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Assessment Center User Manual

1. Page 34 SH Assessment Center How do I administer every item from a CAT instrument A CAT engine does not administer all items within the instrument If you want to administer all items that make up the item bank you will need to access the Set CAT Parameters page and change the standard error to 0 As this is statistically impossible all items will be administered You will also need to ensure that the value in the Maximum Number of Items field is larger than the total number of items in the bank Assessment Center E p PDF Admi My A t Hel L t ST instruments Mena me E a T y ee Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization gt gt CAT Parameters CAT Parameters Set Parameters for New Language Save Cancel Instrument AC User Manual Example Instrument IRT Model Graded Response Model CAT Parameters Language All Languages Calibration Sample Promis Wave 1 Reset to Default Parameters Item Section Selection Method Max Posterior Weighted Info MPWI v First ltem Select Y Theta Item ID Prior Distribution Mean 0 Standard Deviation 1 Stopping Conditions Number Of Items Minimum 4 Maximum 12 Standard Error 0 CAT Short Form No Duplicates Engine How do administer a CAT followed by every tem in a short form not selected by the CAT engine Some researchers may want to be able to
2. Page 11 SH Assessment Center Assessment Center E gt E sare PDFs Admin MyA t Help Logout Studies BS a Co TS mn MyAccount heip Logou Current Study AC User Manual_Example Study List AC User Manual Example gt gt Study Team Study Team Save Cancel 1 Identify the members of your team by selecting their names and using the arrow keys to move their names to the Team Members for Current Study box 2 Highlight a team member s name from the list then select the role s they hold for this study other than Associate read only All Users Team Members for Current Study Roles 123 login NU Hanrahan Rachel Northwestern University Y Study Administrator Create studies manage team AAKRE CHARLEY ABAJA CHANTE E _ Instrument Item Administrator Create change instruments manage study set up pera tomate D Study Participant Administrator Recruit manage demographics ABATE ERVIN mm Study Data Entry Administrator Enter Edit study participant responses ABATO JERRELL D Data Statistics Administrator Export data for statistical analysis ABBOUD HORACIO ABDELRAHMAN NELLA Associate Default read only access Abel Rebekah Northwestern University Instruments How do view my study Instruments All instruments selected for use in a study are displayed on the Study Content page the default page in the Instruments tab From the Study Content page users can add ins
3. Assessment Center CAT IRT Parameters Do need to enter parameters in order for an instrument to be scored CAT IRT parameters inform the administration engine how to give an assessment accurately according to the algorithm established for that instrument All CAT Computerized Adaptive Testing instruments and all short form instruments with an IRT Model field set to Graded Response Model Scored are scored An instrument s CAT IRT parameters cannot be changed within a study once that study has been launched Default CAT IRT parameters have been set for all public instruments e g PROMIS and NeuroQOL CATs in Assessment Center If you utilize a public scored instrument in a study you will have the option of modifying the default CAT IRT parameters Assessment Center will then administer the public instrument using the parameters you entered on the CAT Parameters page You must set parameters for scored instruments you have created The parameters you set for a custom scored instrument will become the default parameters for that instrument Other users utilizing your custom scored instrument will have the option of using the default parameters or modifying them to their specifications Any modifications made to default parameters will only be applied for the current study i e the default parameters will not change Users with Study Administrator or Instrument Item Administrator roles may add or modify CAT IRT parameters You may acce
4. Additional information including limitations of use copyright and expectations for sharing summary data are outlined in the Terms and Conditions https www assessmentcenter net TandC aspx All users indicate agreement in adhering to the Terms and Conditions at the time that they register in Assessment Center The Terms and Conditions include a lot of information Here are a few highlights First users of PROMIS version 1 0 tools are required to submit a brief report to helo assessmentcenter net including sample demographic information clinical data sufficient to define the sample without indicating treatment response data and PROMIS score distributions e g baseline mean and standard deviations or change scores blinded to treatment information for internal review No data will be published without the participation of the submitter Second clinical researchers are strongly encouraged to collaborate with a PROMIS investigator when applying these instruments to their research Third any publication or presentation of results should include a statement that PROMIS v1 0 instruments were used and reference www nihpromis org for further information Finally permission to use PROMIS v1 0 instruments does not grant permission to modify the wording or layout of items to distribute to others for a fee or to translate items into any other language Page 78 SH Assessment Center What are my responsibilities when using Assessment Center Ass
5. Fatigue In the past 7 days How often did you feel tired Responses Never a Sample Population Description PROMIS Wave 1 Full Bank Mean Alpha Adj Alpha Item Total Adj Item Total o Score Reliability Reliability Correlation Correlation Omit Option Option Option Option Option 1530 52 2000 ee ee i i Differential Item Functioning DIF Information Update IA E PROMIS Male Female a 0 0920 oo O 0 9852 Calibration Sample Description PROMIS Cancer Sample Population PROMIS Age lt 65 IRT Model Graded Response Model Category Response Function U Item Information Function Y Model Ft amp Scalability Iudices L Jivatwe Prob sx eoo owwo so foon fe o oo Jo ccco cz ooo foo Loevinger H Scalability Location At Max Information Threshold 1 is between the lowest scored response and the next highest response s IRT Parameters Se CB Threshold CB Threshold CB Threshold CB a How do create more than one set of item level parameters Items within Assessment Center may have more than one set of item level parameters This enables the system to administer the same item but with different calibrations Calibrations are identified by the name of the calibration sample All calibration sample statistics e g IRT parameters are entered at the item level on the Item Statistics page It is necessary to complete the Sample Population section of the
6. If a study researcher is registering participants the study arm can be assigned during registration The Advanced Study Set up page defaults to having a single armed study with a single assessment If you wish to create multiple arms click the New Row button Enter the arm name in the Arm field Any variation in the text entered into the Arm field will indicate a new study arm Therefore it is important to ensure the names given to a particular arm e g control are spelled exactly the same in each new row Page 43 SH Assessment Center Assessment Center LS es LL e PDF Admi t Hel L Studies instruments Set up Assemble Administration gt io E Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual_Example Advanced Study Setup Create at least one arm assessment instance and click Save You will then be able to click on the Specify Instruments link a Advanced Study Setup has been saved Arm Assessment Day Assessment Opens Window Save Cancel Control f E Day 0 4 Days Specify Instruments Delete Control 2 Day 17 4 Days Specify Instruments Delete Intervention i EN f Day 0 a 4 _ Days Specify Instruments Delete Intervention Day 17 4 Days Specify Instruments Delete How do I determine how many arms to use in Advanced Set up There are a number of factors to consider when determining how many ar
7. amp Statistics Administrator may export raw data files You can check more than one Role box for your team members in any combination that is useful to you Each role has very specific rights For example some roles allow a team member to modify items whereas some roles allow a team member to manage participant data It is likely that you will assign team members to multiple roles unless you have a very large team with individuals holding narrow responsibilities Second Assessment Center data is segregated into different files Participants registration consent and assessment responses are stored separately This means that PHI that is needed for study management e g participant name contact information for sending study incentive or endorsement text for an online consent form are stored in files separated from participants responses to study items Finally all data collected in Assessment Center including confidential personal health information is maintained and secured at Northwestern University Research Data Center in Chicago IL The following text will provide information about security measures at Northwestern University Research Data Center which ensure all data collected stored and maintained in Assessment Center is protected We observe high standards of data security practices Our approach to security consists of a collection of policies procedures and practices that are designed to balance the following three chara
8. than 66 percent of people in the general population 56 percent of people age 45 54 30 80 62 percent of females Better Average Your estimated score on the Physical Function questionnaire is 39 Your estimated score indicates that your level of Physical Function is higher better than The diamond is your estimated score For each of the areas above a score of 50 is p average for the United States general population Most people will score between 40 5 be al aba se seed and 60 and almost all people will score between 30 and 70 22 percent of females The Standard Error SE is a statistical measure of variance and represents a margin A A of error around your estimated score The lines on either side of each diamond reflect Your estimated score on the Satisfaction with Social Roles questionnaire is 45 Your the likely range of your actual score estimated score Indicates that your level of Satisfaction with Social Roles ls higher batter than 34 percent of people in the general population 32 percent of people age 45 54 38 percent of females Researcher Reports Are there study reports available There are three standard reports for researchers on the Study Overview page the Data Dictionary report the NIH Inclusion Enrollment Report and the Enrollment Report These reports open in PDF format They can be printed or saved outside of Assessment Center Assessment Center Studies Instruments Set up ES 11 a A
9. 51275 and Password mus Begin Administration What is the purpose of the Administration tab The Administration section of Assessment Center is used to track accrual review participant information run reports and export study data The default page under the Administration tab is the Study Overview page There are several features on this page that will be frequently accessed once a study is in data collection The Study Overview page will provide users with essential accrual information and reports The other sub menu tabs Registration Details Participant Details Contact Information Custom Fields Reports and Participant Data are only accessed from within an individual participant s record Accrual How do track study participant accrual The Study Overview page displays the current study name in the top left hand corner Below this is the Accrual Dashboard The dashboard provides a quick summary of current accrual status and can be used to calculate Page 61 Assessment Center response rates Users may also access the Enrollment Report to review study accrual in more detail The accrual dashboard is updated on 20 minute intervals Assessment Center SU TES A ee Cot ae Administration a ee Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 Study Overview Study AC User Manual_Example2 Goal Partici
10. Archive a study You should only select this status if all work within Assessment Center is complete Archived studies remain in Assessment Center for historical review although you do have the option to hide Archived studies Page 9 SH Assessment Center Assessment Center Studies MUS Sn at EE Current Study AC User Manual_Example Study List AC User Manual Example gt gt Study Properties Study Properties Name of Study AC User Manual_Exarr Description AC User Manual_Example Study Status fields are required Study Team How do I determine my study team You may want to add other Assessment Center users to your study team Adding others to a study team will enable these users to view your study and depending on the roles you assign them conduct various study related tasks e g pick instruments or export data It is important to carefully consider who should be added to your study and what roles i e permissions these users should be assigned All team members will need to have registered and logged into Assessment Center at least once before they may be added to your team Designate which team members you want to be part of your study as well as their roles by first selecting the Team hyperlink from the Studies page The All Users list box on the left of the Study Team page lists the names of all users across all institutions registered in Assessment Center To add one of these
11. Border lacinia tortor Nunc iaculis nibh non iaculis aliquam User Manual_ Example https msswebtest fsm northwestern e f orci felis euismod neque sed ornare massa 5 mauris sed velit Nulla pretium mi et risus Fusce mi pede tempor id cursus ac ullamcorper nec enim a Sed tortor Curabitur molestie Duis velit augue VSpace condimentum at ultrices a luctus ut orci Donec pellentesque egestas eros Integer cursus augue Alignment in cursus faucibus eros pede bibendum sem in tamnna talla innta nuin tiesto Tnn anntindar not set gt AC_User_Manual_Exa HSpace Advanced Study Set up How do I set up a more complex study Advanced is the second sub menu tab under Set up The Advanced Study Set Up page allows you to create studies that have multiple arms e g intervention and control multiple assessments for longitudinal study designs and customized instrument presentation per arm assessment Create Multiple Study Arms How do create a study with more than one arm Frequently research designs have multiple arms An arm can be defined as a grouping of study participants Multiple study arms should be used when study participants will not all have the same protocol e g different instruments different assessment schedule Assessment Center allows a researcher to tailor the content of the assessment within each arm If a study utilizes participant self registration Assessment Center assigns a participant to a study arm
12. Center allows researchers to complete the registration process for participants within the Administration tab Note that the study must be launched in order for registration to occur To register a participant click on the Find Create Login button Complete applicable fields on the Registration Details page Click on the additional registration submenu tabs Participant Details Contact Information Custom Fields and fill in any required information When finished click on the Register Participant button at the bottom of the page The Login will appear in the top right Note that researcher based registration requires that consent is obtained outside of Assessment Center A login is not able to be created if the Consent Field is not completed Additionally researcher based registration assumes that a researcher is entering all required registration information e g demographic variables A participant will not see any consent or registration screens if his or her login was created by a researcher Page 65 SH Assessment Center How should a participant registered by study staff access the data collection website After registration is complete a study participant should be provided the data collection website URL which can be found on the Launch page within Set up Once they access the study Welcome home page they will be asked to enter their assigned login and password and click Start They will then be navigated to the first assessment
13. I look at my data in the middle of a study Users can run exports at any time during a study To retain a version of the export without adding additional cases users must save the export files outside of Assessment Center The data exports will always contain all study data and will not be able to truncate data based upon previous exports Pivot Data Export How can pivot the Assessment Data export or other export files As previously noted the Assessment Data export is organized with each item in each assessment for each participant in its own unique row The Pivoted Assessment export is functional only for smaller studies However one can pivot or transpose larger datasets using Excel s PivotTable function Using this method the numeric data from any Assessment Center export can be transposed into a flat file as long as there are no more than 1 048 576 rows in the data export file If using a version prior to 2007 the row limit is 65 536 To pivot a data export first open the Assessment Center data export csv file in Excel and saved on your computer Next delete the first two header rows at the top of the worksheet Then select the insert tab and click on the PivotTable button Page 75 SH Assessment Center Once you have clicked on the PivotTable button the Create PivotTable dialog box will appear see Figure 1 Select the options Select a table or range and New Worksheet It is important to verif
14. Instrument AC User Manual Example Instrument Administration Method Set IRT Parameters Instrument order is Random Define Randomization below Y Randomize Item Blocks Y Randomize Items within Item Blocks Templates determine how an item will appear to study respondents on the data collection screens Change all item faites to Please select Branching If Then Go To Template ACUM_4914 Inthe past 7 days I felt very tired Not at all Please Select v Vertical 01 A Little bit Somewhat Quite a bit Very much FATIMP15 In the past 7 days How often did your fatigue interfere with your ability to engage Never Please Select v Vertical 01 in recreational activities Rarely Sometimes Often Branching Sometimes you may want a participant to skip specific items dependent upon his or her response to a previous item This is can be accommodated by selecting an Administration Method of Branch Using the Branching If and Then Go To fields for each item you can select the response choice that will result in skipping a specific item s and direct the participant to the next desired item To select multiple response choices in the Branching If field hold down the Ctrl Control button and use your mouse to make multiple selections Assessment Center Ser ae instruments Mr T Cer Dl o pas Current Study AC User Manual_Example Study Content AC User Manual Example
15. Intensity IRT Model Graded Response Model Scored Y Pain Interference Physical Function Upload PDF Mobility Upper Extremity Description of AC User Manual Example Instrument Comments 5 fields are required To add existing items to your instrument first on the Study Content page click on your custom instrument name hyperlink This will take you to the Instrument Detail page From here access the Assessment Center Item Library by clicking on the Find Items button Once on the Add Items to a Custom Instrument page you may select items to include in the custom instrument The Add Items to a Custom Instrument page looks very similar to the Add an Instrument page The search drop lists the default instruments and the hyperlinks are the same When adding items to a custom instrument you can select all or some items from within an instrument To view items click on the plus minus box next to an instrument name To select all items from an instrument check the box next to the instrument name To only add some items from an instrument expand the instrument and check the boxes next the desired items The library defaults to display All Public instruments However you can select any study that is publicly available or any study on which you are a team member All instruments that have a status of Administered or Public may be viewed Therefore if you create an instrument
16. Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Study Arm Schedule Date Approach Site Login optional Password Study code Baseline Consent Mon Enrollment Reason Off Study Language Only required for consented participants default Default 4 9 2014 Internet 45454 04 09 2014 Yes English Participant Schedule View Schedule Details Y Create participant login Preview Participant Data Assessment 3 Assessment 3 Assessment 4 Assessment 4 Assessment 5 Assessment 5 Assessment 6 Assessment 6 Assessment 7 Assessment 7 amp SS A BS BS BS BS KE Assessment 8 Participant View Clinician View Participant View Clinician View Participant View Clinician View Participant View Clinician View Participant View Clinician View Participant View 11 15 2011 11 18 2011 11 18 2011 12 01 2011 12 01 2011 12 08 2011 12 08 2011 12 15 2011 42 15 2011 12 22 2011 12 22 2011 12 29 2011 12 29 2011 01 05 2012 End Date 11 97 2011 11 17 2011 12 03 2011 12 03 2011 12 10 2011 12 10 2011 12 17 2011 12 17 2011 12 24 2011 12 24 2011 12 31 2011 12 31 2011 01 07 2012 PDFs Admin MyAc
17. Statistics Save Cancel ID ACUM_4914 Version Text Domain Communication ee Emotion Type Multiple Choice Y Add another row Emotional Distress Negative Affect Anger Anxi Fear 7 Poll on ore Response Text o Show Response Score Depression Sadness Not at all Delete Responses End of Life Concerns Item Contains Protected A Little bit Delete Fatigue TA Motor Health Information PHI H Somewhat ley Delete Context Delete In the past 7 days Em Delete Delete Stem I felt tired Administration AC User Original AC User Manual Example Creation 4 9 2014 Study Manual_Example Instrument Instrument Date Thresholds Item Statistics page are another item characteristics that should be considered when there are collapsed categories Assessment Center uses the number of response scores to determine how many thresholds are available for an item Normally when utilizing graded response model GRM an item with 5 response options would have 4 thresholds Since the collapsed response categories are treated as a single response the result is that you would see one less threshold i e 3 thresholds The data export will still show you the answer provided by a participant in the Rspnse Assessment Data Export field This field indicates the position within the response options of a participant s selection e the response option listed first is coded as 1 How
18. Updated versions of some PROMIS Instruments Some PROMIS item banks have had minor modifications typically removal of 1 2 items Assessment Center reserves the right to have regular scheduled maintenance windows Weekly maintenance may be performed on Sunday momings from 7am to 9am CST During this time Assessment Center may be unavailable We apologize for any inconvenience this may have If you have any questions please contact us at help assessmentcenter net Page 7 Assessment Center Alternatively you may log into Assessment Center zip files of PROMIS Instrument PDFs are available from the PDF link in the upper right hand corner of the application This provides quick access to PROMIS instruments without having to navigate further into Assessment Center You must agree to the terms and conditions in order to access the PROMIS instrument zip files Assessment Center ies Mea r Sere a A Na PDFs Admin MyA t Help Logout Studies BUS a Cc MSL mn MyAccount Help Logou Current Study AC User Manual_Example PROMIS PDFs Below are PROMIS Instruments in PDF format Prior to downloading you must accept the terms of use Click on read the terms of use and click agree to accept Study Document Date Published Terms of Use PROMIS 02 13 2011 PROMIS PROMIS Adult Short Forms 02 13 2011 PROMIS PROMIS Cancer Item Banks 03 22 2012 PROMIS PROMIS Adult Profile 29 43 57 04 16 2009 PROMIS PROMIS Pediatric Profile 25 37 49
19. a study This enables users to keep research activities separate and move from the various stages of research easily i e instrument selection to data collection To create a new Study you must click on the Create New Study button and fill out the Study Properties page Study Names must be unique across Assessment Center Page 8 SH Assessment Center Assessment Center Mo ga o qe PDFs Admin M Hel Studies SEE A E TSE DFs Admin MyAccount Help Logout Current Study PROMIS Study List PROMIS Study List To get started please select an existing study or create a new one Then continue work in the system by selecting from the tabs above Create New Study To select click on study name Hide Archived Studies My Studies Name Created By PROMIS Hanrahan Rachel 7 3 2007 Properties ist time Practice ALDERSON JETTIE 7 17 2009 Properties 6723 Sat with Social Roles Profile 29 Hanrahan Rachel 7 17 2013 Properties 6916 ProxyDepSansLocal Hanrahan Rachel 7 19 2013 Properties How many studies should create Assessment Center will allow you to administer instruments from its library as well as create your own instruments If you have a number of instruments to create we suggest making a master study in which you will create and manage all of your custom study instruments This study will not be launched as it is not intended to be used in data collection Instead it is a workspace within Assessment Cent
20. accuracy of financial documents e g bills checkbook or bank statements NOCOG17 How much DIFFICULTY do you currently have counting the None 7 Statistics correct amount of money when making purchases Item components e g stem responses and instrument of origin can be reviewed on the Item Detail page To access the Item Detail page click on the item ID hyperlink Page 14 SH Assessment Center Assessment Center AT instruments EA E T EET a rl ee ee Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Add an Instrument Add an Instrument First select instrument or battery a fixed set of instruments Use search criteria to find and add instruments batteries to your study Instrument O Battery Study Domain All Public All Show Results Search Results Add to Study Administration Study Type Domain Neuro QOL Bank v1 0 Ability to Part Neuro QOL Item Bank CAT Social Function Ability to Participate in Social Roles Activities Statistics in SRA Computerized Adaptive Testing Neuro QOL Bank v1 0 AC Executive Neuro QOL Item Bank CAT Applied Cognition Executive Function Function Computerized Adaptive Testing NOCOG16 How much DIFFICULTY do you currently have checking the accuracy of financial documents e g bills checkbook or bank statements NOCOG17 How much DIFFICULTY do you currently have counti
21. added to the Assessment Center library How do create an instrument To create an instrument in Assessment Center click on the Create button on the Study Content page A blank Instrument Properties page will be presented enter instrument properties e g instrument name type domain language IRT model here There are two instrument types Item Bank CAT Computerized Adaptive Testing or Short Form The options available in the IRT Model drop list are dependent on the type of instrument you select If the instrument type is Item Bank CAT Computerized Adaptive Testing you will need to select Graded Response Model Scored from the IRT Model drop list This is currently the only IRT model available If you are creating a short form you will need to select No Total Score default or Graded Response Model Scored from the IRT Model field Once all study properties have been entered and saved the Study Content page will appear listing the newly created instrument Page 17 SH Assessment Center Assessment Center TN instruments ee Coen T E a a n Togn Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Properties Instrument Properties AC User Manual Example Instrument i i i i EE Select the domain pr domains for this instrument Language Engh y End of Life Concerns ARCOS Fatigue Status Under Development Motor Pain Type Short Form Pain Behavior l Pain
22. aieea nee Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Statistics Instrument Statistics Instrument PROMIS Bank v1 0 Fatigue Update Back Trin tax O A 0490 0 70 0 80 0 90 0100 00 Reltabiity__ 00 52 94 29 99 99 99 99 90 so Total Number of Items 95 Average CAT Length for Target SE Type CAT only Scale Score Definition Sample N Alpha Reliability is Update Promis 14931 Score Distributions Mean so es pio p25 pso p75 poo pos Raw 220 69 91 34 98 00 109 00 142 00 206 00 284 00 356 00 392 00 Scale 51 23 9 41 36 46 39 02 44 31 50 82 57 83 63 97 67 33 Enter Item Statistics 1 Click Statistics link for item Click Update button on Sample Population box Enter data into stats fields Click Update button on Differential Item Functioning DIF box Select sample population in drop lists Enter set of data in stats fields Click Save Click Update button on IRT Model box Enter set of data into stats fields Click Save Click Icon next to Item Information Function and or Category Response Function Click Browse button Select image ee es ee Page 38 Assessment Center Assessment Center Sees Instruments Setup rra IE PDFs Admin MyAccount Help Logout Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Item Statistics Item Statistics ID FATEXP20 Domain
23. can preview all study assessments Once you have launched your study for preview the Administration tab is active and may be utilized during your study preview To review more than one assessment you should manually adjust a preview participant s schedule see Modify Assessment Schedule section above To access follow up assessments re launch the preview by accessing the Preview Study page and clicking the Preview button Enter the preview participant s login and password on the Welcome home page How can endorse Terms amp Conditions Prior to launching study you must agree to applicable Terms amp Conditions Studies which require Terms amp Conditions endorsement will be listed on the Launch Study page To read and accept the Terms amp Conditions click on the symbol for each study listed A pop up will then appear from which you can review and endorse the Terms amp Conditions by clicking the Accept button Assessment Center Dn ane AR Setup Assemble RA eee PDFs Admin My Account Help Logout Build Preview Launch Current Study AC User Manual_Example Launch AC User Manual_Example LAUNCH STUDY You must agree to an instrument s Terms amp Conditions before launching a study Click on the symbol to read and endorse Terms amp Conditions If you do not see a there are no terms and conditions for endorsement PROMIS Endorsed 04 07 2014 Approve your study for data collection by checking the APPROVE b
24. completed your tests navigate to the Administration tab and find the logins test participants by clicking the Participant List button Find the hyperlink next to the test participant s login and password If you collected name in Registration the hyperlink will be the participant s name If not it will be zzzMissingMissing You will then be navigated to the Registration Details page Change the Consent Obtained field from Yes to Test Click Register Participant to save the change In all data exports you will want to only analyze participants with a value of 1 in the Consent field Other values 2 No consent 3 test participant 4 preview participant are not suitable for analyses How can l ensure conduct a comprehensive review using the Preview feature During the preview of your data collection site the study should be reviewed by all applicable study team members e g RAs Study Coordinators Pls to ensure all study elements and requirements are acceptable and accurate It is important to review all study arms and assessments Also it is important to enter test data and export data to confirm data is being recorded as intended All preview participants will appear in study exports with a consent value of 4 If you have created a custom CAT for your study it is important to ensure the CAT is scoring correctly All public CATs and scored short forms have been tested and confirmed by Assessment Center administrators How
25. gt Add an Instrument Add an Instrument First select instrument or battery a fixed set of instruments Use search criteria to find and add instruments batteries to your study Study Domain All Public v All Show Results Search Results Administration Select Name Study Type Domain O Neuro QOL Bank v1 0 Ability to Part Neuro QOL Item Bank CAT Social Function Ability to Participate in Social Roles Activities Statistics in SRA Computerized Adaptive Testing O Neuro QOL Bank v1 0 AC Executive Neuro QOL Item Bank CAT Applied Cognition Executive Function Statistics Function Computerized Adaptive Testing To select an instrument battery for inclusion in your study check the box next to each applicable instrument battery You may select multiple instruments batteries After you have made your selections click on the Add to Study button at the top or bottom of the results list A confirmation message indicating that your selections have been added to your study will appear at the top of the screen The Select box is disabled for all instruments batteries already included in your study so that it cannot be added a second time A single instrument battery may however be administered at multiple time points within a given study How will I know which Instruments to select Review the search results to determine which instrument s would suit your study The search results have information relat
26. hadn t done anything How often did you have trouble finishing things because of your fatigue In the past 7 days Always Never Often Rarely Sometimes How often did you feel tired How often were you bothered by your fatigue How often did you feel tired even when you hadn t don SH En los ltimos 7 d as Siempre Nunca A menudo Rara vez Algunas veces Con qu frecuencia se sinti cansado a Con qu frecuencia le molest el agotamiento Con qu frecuencia se sinti cansado a a pesar 10 PRO Manual Example FATEXP6 anything de no haber hecho nada How often did you have trouble finishing things because of Con qu frecuencia tuvo dificultad para terminar las cosas debido al agotamiento 11 PRO Manual Example FATIMP16 your fatigue It is up to you to ensure the proper translation of your items are entered in the translation file soreadsheet It is recommended that a quality assurance check be completed by a colleague to verify accuracy Once you have entered all translations and saved the exported file on your computer initiate the translation file upload process by navigating to the Instrument Detail page in Assessment Center and clicking the Import button If the file is imported successfully you will receive a confirmation message and the uploaded file will be listed in the File Name column It is important to note to initiate the process of uploading translations items must firs
27. in a pilot study you can create a revised instrument in a second study and add the unchanged items from your first instrument This minimizes the need for re entering custom items Page 18 SH Assessment Center SM Assessment Center TA instruments A E a EEA My Account ee Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument gt gt Add Items to Custom Instrument Add Items to Custom Instrument Select your search criteria Then select the items to add to your custom instrument AC User Manual Example Instrument Study Type Domain All Public EN l Emotional Distress Negative Affect Ma Show Results Search Results Add to Instrument Administration y Select Name Study Type Domain O Neuro QOL Bank v1 0 Neuro QOL Item Bank CAT Anxiety Fear Statistics Anxiety Computerized Adaptive Testing O a Neuro QOL Bank v1 0 Neuro QOL Item Bank CAT Depression Sadness Statistics Depression Computerized Adaptive Testing EDDEP29 In the past 7 days I felt depressed Never Statistics EDDEP19 Inthe past 7 days I felt that I wanted to Never Statistics give up on everything EDDEPOS Inthe past 7 days I felt that I had nothing Never Statistics to look forward to l EDDEPO7 In the past 7 days I withdrew from other Never Statistics le Create an Item How do create my own items to include in a cu
28. item Alternatively you may provide them a participant specific URL created once you finalize their registration i e click Register Participant button This URL will allow the participant to bypass the study Welcome page i e they will not be required to enter their login password before accessing the study assessment The participant specific URL is longer than the URL created on the Launch Study page Therefore the URL should be given to a participant electronically e g email so they may simply click on the hyperlink E e F ee Cee T Administration ee ee ee e a Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 32623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants es bn default Schedule Default View Schedule Details Date Approach 4 30 20 14 Internet Login optional 82623 Create participant login Password usg Study code Baseline Consent C n Preview Non Enrollment Reason Off Study Language The registered
29. of Data and Statistics Administrator will be able to access the data export files Page 74 SH Assessment Center SU STC T E ce Administration So ee Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual Example 3 Study Overview Study AC User Manual Example 3 Goal Participants Accessed Study Registered Started Completed Off Study Refusal 25 0 0 0 0 0 0 To create a new participant registration record click the Find Create Login button To view a list of participants in this study click the Participant List button below Participant List Enter participant login then click Find Create Login button to view an existing participant registration Find create Login NIH Inclusion Enrollment Report Data Dictionary Report Enrollment Report Request and Download Data When your data is available an email notification will be sent to the email below Click buttons to request or download data Please make sure that you are able to accept emails from this r hanrahan northwestern edu Request Assessment Data Assessment Data as of 5 8 2014 2 34 07 PM CST Export Field Descriptions What variables are included in the data exports For a detailed list and description of all the fields in each data export please refer to Assessment Center Help files https www assessmentcenter net ac1 Help index html Can
30. on the Arm Assessment Detail Page to avoid giving a participant the same item multiple times The final warning Translation Warnings will alert you to items which do not have a translation uploaded This warning will only be applicable if your study includes more than one administration language There are also two errors messages which may appear at the top of the Preview page If you receive one of these errors the system will require you to resolve it before launching your study The first error occurs if a study has no instruments added or created To resolve this issue navigate to the Instruments tab and add or create at least one instrument The second error which reads CAT parameters have not been set occurs if you have created a scored instrument but have not set CAT IRT parameters To resolve this error you will need to navigate to the CAT Parameters page to set or modify as applicable and save default CAT parameters How can I review my study before I preview and or launch The Study Configuration Export details your study set up as entered on the Advanced set up tab e g study arms instrument blocks per arm assessment administration engine etc Click the View Export button to open the Study Configuration Export When using a Windows platform the file will open as an Excel file It is recommended you save the report outside of Assessment Center for future reference If the export does not match selections within the Adva
31. or scored Short Form Users have the option to select how the first item in a CAT or scored short form will be determined There are two options within the First Item drop list theta and item ID If theta is selected a text box will appear in which the desired theta value of the first item must be entered If item ID is selected a drop list will appear containing the item IDs of all items within the scored instrument The item selected from this list will be the first item administered in the instrument If no selection is made in the First Item drop list by default the scored instrument will administer the item with the highest information as determined by the algorithm Assessment Center a a PDFs Admin MyA t Help L t So TN instruments AT SO z ames ican br Rane Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization gt gt CAT Parameters CAT Parameters Set Parameters for New Language Save Cancel Instrument AC User Manual Example Instrument IRT Model Graded Response Model CAT Parameters Language All Languages y Calibration Sample Promis Wave 1 y Reset to Default Parameters Item Section Selection Method Max Posterior Weighted Info MPWI v First ltem Select Theta Item ID Prior Distribution Standard Deviation j Maximum 12 Standard Error 0 Upper Bound la Increment 0
32. other important features Assessment Center also enables Downloading library instruments for administration on paper Customization of items or instruments e g format randomization skip patterns Real time scoring of CATs and short forms Storage of protected health information PHI in a separate secure database Automated accrual reports Real time data export Ability to capture endorsement of online consent forms ANNOUNCEMENTS Additional PROMIS Instruments now available in Spanish See the Instrument Library link at left to see what PROMIS instruments are available in Spanish New PROMIS Computer Adaptive Tests for Upper Extremity Function and Mobility Physical Function can now be assessed specifically for upper or lower body function The full Physical Function CAT remains available Updated versions of some PROMIS Instruments Some PROMIS item banks have had minor modifications typically removal of 1 2 items CET ETT Register New User Forgot Password Demonstration CAT Try out a PROMIS Computerized Adaptive Test and get an instant score report CATs include Emotional Physical and Social Health Click here to begin Request PDFs of PROMIS Short Forms 7 Sponsors PROMIS Neuro QOL NIH Toolbox Studies of Interest PROsetta Stone Assessment Center reserves the right to have regular scheduled maintenance windows Weekly maintenance may be performed on Sunday momings from 7am to 9am CST During t
33. participant can access their study at https msswebtest fsm northwestern edu assessmentcenter ga act Action aspx Module 48 amp txtUID2 82623 amp txtPWD2 usg Action autologin amp Study AC_User_Manual_Example2 amp locale en U S May study staff create a participant login A login may be created by study staff on the Registration Details page To enable the login field check the Create Participant Login box The login must be between 5 and 10 characters long may contain both letters and numbers and may not contain spaces or special characters When you create a login you must also enter a password The system will not automatically assign a password Passwords must be at least one character and can be up to 25 characters Passwords may contain any combination of letters numbers or special characters Page 66 SH Assessment Center Assessment Center Studies ara Setup ea Administration PDFs Admin MyAccount Help Logout Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 32623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented par
34. search criteria to find and add instruments batteries to your study Instrument Y Battery Study Domain All Public All Show Results Search Results Add to Study Administration Select Name Study Type Domain O Neuro QOL Bank v1 0 Ability to Part Neuro QOL Item Bank CAT Social Function Ability to Participate in Social Roles Activities Statistics in SRA Computerized Adaptive Testing O E Neuro QOL Bank v1 0 AC Executive Neuro QOL Item Bank CAT Applied Cognition Executive Function Statistics Function Computerized Adaptive Testing NOCOG16 How much DIFFICULTY do you currently have checking the accuracy of financial documents e g bills checkbook or bank statements NOCOG17 How much DIFFICULTY do you currently have counting the correct amount of money when making purchases None Statistics None Statistics Page 15 EH Assessment Center Publicly Available Instruments What instruments for adults are available in Assessment Center Currently PROMIS calibrated item banks which are enabled for Computer Adaptive Testing CAT PROMIS short forms and PROMIS Profile instruments are available in Assessment Center The most recent version v1 0 or v2 0 may be selected for use in a study All publicly available instruments will appear by default when you navigate to the Add an Instrument page The Administration Study field will display the study from w
35. security requirements identified in the AISSP Handbook The following text describes the minimum information security systems safeguards at Northwestern University Data Center as required by federal standards to be used for Assessment Center e Ensure that a complete and current set of documentation exists for all operating systems Operating System documentation can be obtained by visiting the Microsoft website http www microsoft com windowsserver2008 en us product documentation aspx Specific information for supported systems included in a systems profile document is maintained by the System Support team e Require use of current passwords and log on codes to protect sensitive AIS Automated Information System data from unauthorized access All system access requires a user name and password All users who require anything more than internet user security to the Northwestern University campus network must have a unique ID assigned The Northwestern University ID is used to control access to data files and applications that reside on the network Every Northwestern University ID is required to have a complex password assigned Access to Assessment Center is restricted to participants by means of a username and password incorporated within the participant registration process Because SQL Server 2008 R2 is integrated with Windows SQL Server and Windows authentication is used to prevent unauthorized access e Establish procedures to register an
36. so that each item in each assessment for each participant is its own unique row This allows for capturing additional information e g time and date stamp of response but is not organized as typically requested by statistical analysis programs Instructions for pivoting the data set are provided in a later section of this manual The second export Assessment Scores contains participant s t scores for CAT and short form instruments The t scores are based on general population norms These scores can be used to evaluate an individual s status The third export Registration Data contains the data entered into the registration fields The fourth export Consent Data includes information from consent forms It includes whether or not a participant endorsed a consent checkbox the text entered in a consent textbox and the date and time when consent was provided Finally the fifth export Pivoted Assessment Data presents assessment data in a format that is typically used by statistical analysts Each participant is represented in a single row with each column represented scores from an item Item columns are organized in alphabetically order based upon the item ID In a longitudinal study each assessment is stored in a different row Currently the Pivoted Assessment Data Export is only functional for smaller studies Who can view my Study data Only members of the study team with appropriate permission assigned on the Study Team page i e role
37. teams are advised to create standard operating procedures so that staff can consistently follow up when participants meet or exceed the established thresholds Assessment Center does not have the capability of automatically communicating at risk responses to research staff Therefore it is of utmost importance that staff monitors participant data to ensure individuals who are at risk will be followed up with properly How do access the study database Study data can be exported from Assessment Center by running five different exports The data exports open CSV files and can be opened and saved outside of Assessment Center in Excel SAS or SPSS Note that only 255 columns of data will fit in an Excel worksheet If a study has many instruments and assessments the CSV file should be opened in a statistical software package to avoid truncating data The data exports must be requested by clicking the Request Data buttons on the Study Overview page The system will generate the export and send an email to the address entered in the Email Notification field once the export is ready for download Once the email is received you may click on the Download Data button which will open the CSV file The file is organized by participant then assessment What is included in each data export The first export Assessment Data contains a de identified dataset of all study instrument and item data no registration data is included Note that this export is organized
38. the Administration tab Only team members with proper roles on the study may view Study Administrator Study Participant Administrator or enter modify Study Data Entry Administrator data By default participants are presented all instruments On the Arm Assessment Details page you can indicate if an instrument should not be presented to the research participant by unchecking the Completed by Participants box Page 50 SH Assessment Center Assessment Center 2 PP PDF Admi My A t Hel t Studies instruments Set up Assemble Administration san o s7 Ekas Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual Example gt gt Specify Instruments Arm Assessment Details Arm arm1 Assessment 1 Save Back Instruments can be blocked These blocks can be administered randomly or in a fixed order Instruments in the same block are administered together in a random or pre defined order Instrument Block Block Administration Instrument Order within Block Completed by Participant Administer 7 ixec PROMIS Sociodemographic Example 1 All Items PROMIS Clinical Form Example 2 All ltems Random PROMIS Bank v1 0 Depression Random CAT Random Y PROMIS Bank v1 0 Anxiety Random Y CAT Random Y Clinical Performance 1 v All Items Avoiding Redundant Items Am
39. 04 16 2011 PROMIS PROMIS Pediatric Short Forms 06 12 2009 PROMIS PROMIS Sexual Function Profiles 06 20 2012 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 Endorsed 01 10 2013 PROMIS PROMIS Parent Proxy Item Banks and Short Forms 07 07 2011 PROMIS PROMIS Pediatric Item Banks 09 09 2011 PROMIS PROMIS Adult Profile Short Forms Investigator 09 26 2010 PROMIS PROMIS Adult Profile Short Forms Participant 09 26 2010 0000000000 ofo PROMIS PROMIS Sexual Function User Manual 10 19 2011 Studies MyStudies List The first screen you access in Assessment Center will be the Study List page within the Studies tab Note that you may have multiple studies and name them whatever you wish In the MyStudies list you will see studies which you have created and studies in which you have been identified as a team member The MyStudies list first organizes your studies by the most recently accessed and then in alphabetical order Select any study from this list by clicking the study name hyperlink The system will default the current study to the last study you worked on in Assessment Center Create a Study Why do I need to create a Study The structure of Assessment Center is based around studies All research activities conducted within Assessment Center are nested under
40. Additionally registration information is stored in a database separate from the instrument data This allows a researcher to keep PHI separate thereby having access to a de identified dataset Assessment Data export How do select registration variables to include in my study To select registration fields to be administered to participants navigate to the Registration sub menu tab within the Set up tab On the Registration page there are standard registration fields on the left and customizable registration fields on the right click the plus minus symbol to view each field type Check the Include box for all registration Page 53 SH Assessment Center fields you wish to have administered to participants If you would like to require that a participant provide information in a field check the Required box It is important to note participants will not be able to move forward without providing required registration information You may also enter minimum and maximum values for validation This may be useful when you want to ensure only eligible individuals can access the study e g over age 18 Participants who provide responses outside of the range will receive a message noting they are not eligible for the study If you are collecting data in a non English language the standard registration fields will displayed in the participant s selected language Several standard registration fields will always be marked as containing PHI Th
41. Assessment Center ASSESSMENT CENTER USER MANUAL Version 9 6 COPYRIGHT NOTICE Assessment Center User Manual is 2007 2014 David Cella Ph D Richard Gershon Ph D Michael Bass M S Nan Rothrock Ph D Page 1 H Assessment Center Table of Contents RECI OT rre 4 e OA 8 MYStId les stands 8 CROATA Mar oe OT 8 do CA I PERA 10 IVS ETON UVES entera irlanda E A acens 12 Add an instrument Baterista daba 12 VIEW StS UCS PALOS ainia ise 15 P blicly Avallable WS ti IONS sist di isis 16 Ereate a INSUMOS asas adas 17 Create a Meson dise 19 EGTA Response DES ariba iba aa 20 Rin e e OE 22 Lada Sido q ePOS A e UU E E A 25 MAMONT EX DONE ass aE doi er tii ici etica 26 Exclude an WV EU Or Meir acti 27 AO E Po 5 E 28 MSTUMEnt Ccustomizati Dorantes 28 PS e o e o PP Pi E lt lt 28 A e E RA 29 TOMATE necia 30 CATUR Parane tE arias inca E E A E drid lacra tenes 32 CAT Short Form No Duplicates Engine ccccccccccccsssccsecccccceeseeesccecccssessueeeesececessseeeueeesceesessesuuueeeeeesesess 35 aA E EE PP e E E E I 36 AO SUSO ota 37 Instrument Terms Of USC aniston iia aio aiii 39 NSTUument POE S ica 40 Making Instruments Publicly Available susi ii 40 O PPP O E O POC IA 41 PAIN UAC E A E T A EE A E A TO E P A A E A A E E A E TT 41 a A e O E EE AAEE EEA N 42 PV LINCS O Study Seu sasaki ates ate eas pcan swt tetas rane ae nae cea E ees E eens 43 Create Multiple Sta AROS nar oa 43 Create Multi
42. Create Item Find Items Upload Translation Analyze Preview Export Instrument Detail Responses Administration Study ACUM 4914 In the past 7 days I felt very tired Not at all AC User History Statistics Manual_Example FATIMP15 Inthe past 7 days How often did your fatigue interfere with your ability to engage in Never PROMIS History Statistics recreational activities NEV FATIMP16 Inthe past 7 days How often did you have trouble finishing things because of your Never PROMIS History Statistics fatigue FATIMP17 Inthe past 7 days How often did your fatigue make it difficult to make decisions Never PROMIS History Statistics FATIMP18 Inthe past 7 days How often did you have to limit your social activities because of your Never PROMIS History Statistics fatigue 7 Statistics FATIMP20 Inthe past 7 days How often did your fatigue make you feel less alert Never PROMIS History Statistics FATIMP19 Inthe past 7 days How often were you too tired to do your household chores Never PROMIS History Statistics FATIMP21 Inthe past 7 days How often were you too tired to take a bath or shower Never PROMIS History Statistics There are some instruments that cannot be excluded from a study as a whole For example once you add a Toolbox instrument you are not able to exclude that instrument on the Study Content page using the Include Exclude feature However you are able to e
43. Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 82623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants default Default View Schedule Details 4 30 2014 Site Login optional Internet 82623 Create participant login Password usg Study code Baseline Consent O x Preview Non Enrollment Reason Off Study Language English The Participant Details page contains sociodemographic information such as race age and gender This page also includes a comments field that may be used to input additional details about a participant Assessment Center SU STC a E ae Administration OS eee l E e Overview Registration Details Participant Details PM Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 82623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been inclu
44. Instrument Block Block Administration Instrument Order within Block Completed by Participant Administer Fixed v PROMIS Bank v1 0 Fatigue Y CAT Fixed v AC User Manual Example Instrument No Duplicates Y Fixed PROMIS Bank v1 0 Anxiety i CAT v Page 51 SH Assessment Center Add Consent Forms How do I add study consent forms The Consent sub menu tab allows you to include up to three online consent documents per language for participants e g consent assent HIPAA Consent forms are not required by Assessment Center to administer a study and the inclusion of consent forms is dependent on institution specific procedures It is important to verify requirements with your institutional review board IRB prior to launching a study in Assessment Center It is the responsibility of users to ensure compliance with IRB regulations not Assessment Center or Assessment Center administrators What consent forms should I use Assessment Center does not regulate the text that is entered into the consent form fields However it is essential that users consult with their institution s IRB office to ensure their study has been reviewed and approved If a study is approved as exempt and not needing a consent form this can ONLY be determined by the IRB users should not use the Consent page If a study has been reviewed and the institution specific IRB has approved use of the Asse
45. Item Statistics page prior to attempting to complete the Calibration Sample section When entering calibration sample data you will need to select the sample population for which the data applies as there may be more than one calibration sample record per sample population Instrument Terms of Use How do view an instrument s terms of use Instrument may have unique terms of use Clicking on the symbol will present the Terms and Conditions for that instrument You do not have to accept the Terms and Conditions at this point However you will need to accept the Terms and Conditions prior to opening an instrument PDF zip file or launching your study You may accept the terms and conditions for individual instruments on either the Add an Instrument page or the Study Content page You may navigate to the Launch Study page or PDF link to accept the Terms and Conditions for a group of instruments e g PROMIS instruments Page 39 SH Assessment Center Instrument PDFs Are paper versions of instruments available Assessment Center contains PDFs of existing instruments to be used for paper and pencil administration These are accessed through the Study Content or the Add Instruments pages by clicking on the PDF icon to the far right of each instrument listing Additionally zip files of instrument PDFs are available on the PDF page hyperlink in the upper right All of the PROMIS instruments have PDF versions available You must en
46. Manual_Example Study Content Click the Add button to add instruments to your study Click the Create button to create custom instruments in your study add Save Create You have selected the following instruments for this study Order the instruments by entering the desired position into the text box then click Save To exclude an instrument from your study click on the Include checkbox Hide Excluded Instruments Study Content Name Administration Study Include PROMIS Bank v1 0 Fatigue PROMIS Customize Preview Properties Statistics AC User Manual Example Instrument AC User Manual_Example Customize Preview Properties Statistics PROMIS Bank v1 0 Anxiety PROMIS Customize Preview Properties Statistics Instrument Customization Item Order How do define the order of item administration for my study Item order is defined in multiple places in Assessment Center It is important to note that item order is irrelevant for CAT instruments as the CAT administration engine will select order of items Within a non CAT instrument however you have the flexibility to present items in a fixed branched or random order If you want to administer items within a custom instrument in a fixed i e sequential order first navigate to the Instrument Detail page by clicking on the instrument name hyperlink from the Study Content page Then type in the correct order number in the Order field If you wish to present items in a random
47. Parameters Ttem Section Selection Method Max Posterior Weighted Info MPWI v Firstltem Select Y Theta 0 00 Item ID Prior Distribution Mean 0 00 Standard Deviation 1 00 Stopping Conditions A Number Of Items Minimum 14 Maximum 12 Standard Error 0 30 Information Likelihood Function Lower Bound 4 00 Upper Bound 4 00 Increment 0 1000 Exposure Control Group Size 1 Users may enter a set of administration parameters per language To establish an additional set of parameters for an additional language click the Set Parameter for New Language button This will create another instance of a CAT parameters section Within the new section make the appropriate selections from the Language and or Calibration Sample drop lists modify default parameters as applicable and click Save Users only need to set parameters for a language if the parameters are different than those used for the instrument s other languages For example if an instrument is to be administered in English Spanish and French and the English version will use parameters which are different from those to be used for Spanish and French the user should add an additional parameter section where Language English modify applicable parameters and click Save The user does not need to do the same action for the other two languages as they will be using the same set of parameters i e Language All Languages Users may not modify the Languag
48. Sponsors PROMIS Neuro QOL NIH Toolbox Assessment Center reserves the right to have regular scheduled maintenance windows Weekly maintenance may be performed on Sunday momings from 7am to 9am CST During this time Assessment Center may be unavailable We apologize for any inconvenience this may have If you have any questions please contact us at help assessmentcenter net How could I quickly access instrument PDFs A subset of PROMIS instrument PDFs are available from a button on the Assessment Center homepage Click the Request PROMIIS PDFs button to initiate the process of downloading PDFs A short registration and acceptance of PROMIS Terms amp Conditions is required prior to obtaining the PDFs An email will be sent to the address provided containing a link to a zip file from which the instrument PDFs may be accessed Register New User Demonstration CAT Try out a PROMIS Computerized Adaptive Test and get an instant score report CATs include Emotional Physical and Social Health Click here to begin Assessment Center Resources Forgot Password WHAT IS ASSESSMENT CENTER Instrument Libra Scoring Manuals Assessment Center is a free online data collection tool that enables researchers to create study specific websites for capturing participant data securely online Workshops f ee i f Studies can include measures within the Assessment Center library as well as custom instruments entered by the researc
49. ake instruments available to all Assessment Center users the instrument status must be changed to Public This can only be done by an Assessment Center administrator To request that an instrument be made public please contact administrators at help assessmentcenter net or 1 877 283 0596 Administrators will request additional information about the instrument development to determine if the instrument should be publicly available Page 40 Assessment Center Set up What is the purpose of the Set up tab Assessment Center allows a researcher to set up a study website to collect research participant data This encompasses detailing in which language your study will be administered establishing study parameters e g target sample size how instruments should be administered e g randomization adding online consent HIPAA documents and defining participant self registration fields Language How do l indicate the language in which my study should be administered When you first navigate to the Set up tab you are by default on the Language page This page allows you to select the languages which will be available to participants during data collection Assessment Center Studies Setup Assemble Administration a mgd tangy game nica Language Basic Advanced Consent Registration Current Study AC User Manual_Example Language AC User Manual_Example Language In what lanquage s would you like to administer your stud
50. al s other data e g survey responses Other data associated with an individual will be indexed only by a generic ID Encryption will also be used wherever data is transferred SSL for webpages etc Security The importance for confidentiality of the participant s PHI is recognized PHI will be collected and transferred only where necessary Where possible participants will be identified only by generic ID s SSL encryption will be used with all internet web pages to ensure confidential form submission For data files that need to be transferred electronically the information will be encrypted prior to transport The web servers and associated database servers will be housed on dedicated hardware housed at Northwestern University Research Data Center These will be physically protected from intrusion as well as natural disasters The secure facilities are protected electronically by hardware and software firewalls intrusion detection software anti virus scans and 24x7 monitoring by onsite professionals Northwestern University Research Data Center is completely fitted with redundancy for HVAC power and fire detection suppression systems Page 80 SH Assessment Center Redundant HVAC To provide optimum conditions for equipment operation and minimize downtime due to components overheating the HVAC system provides appropriate airflow temperature and humidity Redundancy features provide additional protection for system op
51. and Ability Estimate Language Response Theta Score SE EDDEP29 4 1 50 65 0 4 49 In the past 7 days EDDEP41 3 1 48 64 8 3 03 I felt worthless Never Rarely Sometimes Often Always CAT Settings Min of Max of Items to Admin Items to Admin Selection Criterion Max SE Pop Mean Pop SD Calibration Sample 5 20 MPWI 3 50 10 Promis Wave 1 Add Statistics How do l add statistics to my instrument An important feature in Assessment Center is the ability to store review and update item or instrument statistics Statistics can only be entered by team members who have the Instrument Item Administrator role within the originating Administration study Statistics can be entered into the Instrument or Item Statistics pages by clicking the Update buttons The Item Statistic page also allows users to upload two statistical graphs These graphs must be created in various statistical programs and then copied into an image format e g joeg prior to being uploaded to Page 37 SH Assessment Center Assessment Center It is important to note universal image format should be used so that the graphs can be viewed in various browsers Enter Instrument Statistics 1 Click a Statistics link for an instrument 2 Click the Update button next to the desired statistical field 3 Enter data into the appropriate statistical fields in the popup screen Assessment Center TES instruments eae ee ee oe sori Larges
52. ants 18 Who should participants contact with questions Basic Set up page 19 What information should be on the study welcome screen Basic Set up page 20 When should the study close e g date or accrual goal Basic Set up page 21 Does the study include scored instruments e g CATs do they have parameters CAT Parameters page How can reduce errors in creating a study Utilization of the study Preview featureand going through all assessments as a test participant are highly recommended before beginning participant accrual The Preview feature described earlier will allow you to check the format of items including how they appear in the selected template testadminstraiton engines andverify all instruments are included as planned and instructions or transition screens are appropriate Completing all assessments as a participant and exporting the data will minimize the likelihood of conducting data collection with errors or bugs The Assessment Center Administrator helo assessmentcenter net or 1 877 283 0596 is available to address any problems you may encounter that are not covered within this manual Copyright and Terms of Use What are my responsibilities when using a PROMIS Instrument Additional information about PROMIS instruments including bank development history available banks and short forms domain definitions administration scoring validity and interpretation is available on the PROMIS website www nihpromis org
53. arely 3 Sometimes Unknown or 4 Often LE 5 Always EDDEPOS5 In the past 7 days felt that had nothing to look forward to 1 Never 2 Rarely 3 Sometimes In the past 7 days felt helpless 1 Never 2 Rarely 3 Sometimes 4 Often 5 Always The NIH inclusion enrollment report is a tool for monitoring study accrual The format PART B HISPANIC ENROLLMENT REPORT Number of Hispanics or Latinos Enrolled to Date adheres to the requirements from the National Institutes of Health NIH for periodic progress reports Information about gender is cross tabulated with race and ethnicity information This report is populated by data from the registration fields and is automatically updated as new participants are Racial Category Tota oralsubiess e PROMIS ENROLLED Consented and on study registered Age Gender Race Ethnicity Hatha Hawallan Hon Hoi Site Count Mean 3D Ranga Female Male American Aslan Black Pacificls white Other Hispanic Hispanic Provided The Enrollment Report isa Internat 3 MM 0 0 o 0 00 o 000 o 000 0 200 0 000 o 0srlo oom 000 acon 000 o 0 05 tool for monitoring study o 0 0 0 0 O 000 0 000 O 000 o 000 0 0 00 0 000 0 000 0 0 00 0 0 00 0 00 0 0 00 accrual The report details current counts of study participants by enrolled those off study and those refused by gender and race This report is automatically updated as participants are r
54. arked Panic Hardware is installed on all Emergency Exit doors All Emergency exits are properly marked e Install fire suppression equipment in the computer facility which may include area sprinkler systems with protected control valves and or fire extinguishers Emergency fire suppression equipment is installed in the computer facility and is tested on a periodic basis Fire extinguishers are located throughout the building and are appropriately marked for easy access e Provide emergency power shutdown controls to shut down AIS equipment and air conditioning systems in the event of fire or other emergencies Emergency Power shutdown controls are located at each entrance to the operations center e Establish a fire emergency preparedness plan to include training of fire emergency response teams development and testing of an evacuation plan and on site orientation visits for the local fire department An Emergency preparedness plan is in affect which include training evacuation plan and on site orientation with the local fire department e Northwestern University provides comprehensive data backup All data is stored in a dedicated storage server on top of redundant disk array A snapshot of the virtual machines is taken every night and stored on backup storage that is alternated every two weeks A full backup of the database is taken every night with incremental backups taken every two hours e Secure communication lines Communications lines
55. at all Instrument customization page 6 How are instruments ordered Sequential Randomized Grouped together Arm Assessment Details page 7 Do you need any transition screens How should they be phrased Study Content amp Item Detail page 8 How many assessments are included in this study Advanced Set up page Page 77 SH Assessment Center 9 What is the timing of each assessment Specifically how many days does a participant have to complete an assessment How many days are between each assessment Advanced Set up page 10 Are there multiple arms in the study Advanced Set up page 11 Are participants assigned to a study arm by the system or placed in a study arm by a researcher 12 What instruments are administered in each assessment for each arm Arm Assessment Details page 13 What protected health e g name address date of birth and other registration information e g gender race ethnicity need to be captured Registration page 14 Who else on the study team should have access to the study site What is his her role e g need to export data enter data register participants Team Member page 15 Will an online consent form be needed Consent page 16 Do some participants receive different consents e g 3 sites with 3 different institutional consent forms would require 3 studies with separate URLs 17 Will participants register themselves or will a study team member register particip
56. at occurs if an item or an instrument does not have applicable language translations uploaded All item translations must be uploaded per instrument via the Instrument Detail page If an item or an instrument does not have applicable language translations uploaded these items or instruments will not be administered to participants who select to complete the assessment in the applicable language The Preview tab contains a warning which will list the items which are missing an item translation You may navigate back to the Instrument Detail page at any time prior to Launch to upload additional item translations Basic Study Set up How do start setting up a website to collect participant data The Basic Study Set up page allows you to create a data collection platform by entering study information about sample size study web address start and end dates and contact information You may access a detailed description of each field within the Basic Set up page within Assessment Center Help https www assessmentcenter net ac1 Help index html Assessment Center LL LTS LS LL PDF i A Hel Studies instruments Assemble Administration DFs Admin My Account elp Logout Language Basic Advanced Consent Registration Current Study AC User Manual_Example Basic Study Setup AC User Manual_Example Basic Study Setup You may define participant registration forms below Save Cancel Start Date 4 7 2014 Login screen welcome message maxi
57. ated by commas The custom list responses have a character limit of 500 For each custom registration field you are responsible for entering the field label text This is the text which will inform the participant what to enter in the field e g what is the date of you diagnosis or please select your disease type from the list If your study collects data in multiple languages there will be a section per language so you may enter text in each applicable language You will click the plus minus sign to expand each section The additional custom fields can be marked as PHI by checking the PHI box within each field row Assessment Center gt NTE a ae PDF Admi My A t Hel L t Studies instruments Set up Assemble Administration gt a TORTA E aa Language Basic Advanced Consent Registration Current Study AC User Manual_Example Registration AC User Manual_Example Registration You may define participant registration forms below Custom Demographic Fields Include Field Label Required Validation Min Value Max Value Age a L Date of Birth Gender Ethnicity Race Doctor First Name Last Name Street City Additional Custom Fields Date Field Number Field Validation Include Required PHI Min Value Max Value O Field Label English Label for Number Field French Label for Number Field Number Field Save Cancel Page 54 SH Asses
58. best identifies their responsibilities within the study The only roles that will be able to view participants data and personal health information PHI are Study Administrator Study Participant Administrator Study Data Entry Administrator and Data amp Statistics Administrator It is important to be very thoughtful when assigning these roles Only the Study Data Entry Administrator may edit participant data while only the Data amp Statistics Administrator may export raw data files You can check more than one Role box for your team members in any combination that is useful to you Each role has very specific rights For example some roles allow a team member to modify items whereas some roles allow a team member to manage participant data It is likely that you will assign team members to multiple roles unless you have a very large team with individuals holding narrow responsibilities What is my role as the creator of a study The creator of a study is defaulted to the role of Study Administrator This role may not enter or edit participant level data and export datasets If the Study Administrator needs all permissions within AC click on the Team hyperlink highlight the name and check all boxes under Roles How do remove people from my study team To remove a team member from your study click the person s name and then click the left arrow button Assessment Center removes the name from the Team Members for Current Study box
59. blank Assessment Center Studies Instruments AT 1118 Administration ia is Overview Registration Details Participant Details Contact Information Custom Fields Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 86918 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants Study Arm default ae Default j View Schedule Details Eae a 4 16 2014 Site Internet Login optional 86918 Create participant login Password nsw Study code 6001 Baseline 4 16 2014 a Consent ves Y VU Preview Non Enrollment Reason Off Study Language En gl ish What information do the CAT and Profile reports provide The PROMIS CAT and PROMIS Profile reports open as PDF documents that can be printed or saved outside of Assessment Center For each domain the participant s standard score is provided along with information on how that score compares with other people in the general population If age and gender was collected during registration the participant s score is compared to other individuals in his her age group and of his her gender Th
60. can I display response scores on data collection pages There are instances in which it may be useful to display response scores to study participants For example an item which asks a participants to place themselves on a 0 10 scale with anchoring text either end of the scale On a scale from 0 10 how would you rank your fatigue To make the values entered in the Score field visible to participants check the Show Response Score box next to each applicable response How can indicate an item contains Protected Health Information PHI Assessment Center allows you to indicate certain data fields contain PHI These fields are any custom item consent endorsement text fields and certain custom registration fields Several registration fields will always be marked as containing PHI These are date of birth doctor last name first name street city state zip email phone 1 and phone 2 When a data field item is marked as containing PHI all data collected in this field will be flagged in the database and will be reported as containing PHI in applicable data exports This feature is intended to aid in de identification efforts and protect participant privacy To indicate a custom item may contains PHI check the Item Contains Protected Health Information PHI box on the Item Detail page This field will not be editable after a study is launched Item Translation How do upload item translations Assessment Center enables you to upload transla
61. ccept study specific terms and conditions within the application as they relate to certain publicly available instruments ASSESSMENT CENTER TERMS AND CONDITIONS Last Updated 1 21 2011 You understand and agree that the services that Northwestern University Department of Medical Social Sciences NU MSS provides to you through the Assessment Center websites are subject to the following Terms and Conditions TAC NU MSS reserves the right to update the TAC at any time Changes in the TAC will apply to new users and to new projects created by existing users after these changes are posted The most current version ofthe TAC can be reviewed by clicking on the Terms and Conditions hypertext link located on the Assessment Center Home page DESCRIPTION OF SERVICES Assessment Center provides you with access to a variety of resources including survey measures study administration data management and storage of statistical analysis results collectively the Services The Services including any updates enhancements and or new features are subject to the TAC and your use of the Services constitutes acceptance of all terms and conditions set forth in the TAC PRIVACY AND PROTECTION OF PERSONAL INFORMATION What if I do not have a Login If you are a first time visitor to Assessment Center and do not have a Login click on the Register New User link on the Assessment Center homepage found at www assessmentcenter net Then complete require
62. complete the remaining items Assessment Schedule How can I view a participant s assessment schedule To view a participant s schedule you must access his her registration record within the Administration tab and then click the View Schedule Details hyperlink on the Registration Details sub menu tab Assessment Center aT ne ee Cee Administration ee di ee Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 32623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants Study Arm default v Schedule Default vB View Schedule Details Date Approach 4 30 2014 Site Login optional Internet v 82623 Create participant login Password usg Study code 6002 Baseline an f Consent y No Test 3 Preview Non Enrollment Reason Off Study Language English How can I change a participant s assessment schedule Sometimes a researcher may wish to change a participant s assessment schedule For example when pilot testing a longitudinal study to ensure that it is
63. count Help Logout Current Study AC User Manual_Example Close Window How would set up assessments without a predefined assessment schedule To create a flexible assessment schedule in Assessment Center first set up the max number of assessments a participant could possibly take on the Advanced Study Set up page Next set the Day Assessment Opens and window fields so no assessments overlap e g opens every 3 6 months Finally each time a participant comes in for a follow up assessment manually modify the assessment schedule via the participant s registration record please see Modify Assessment Schedule section for details T he final step will open up the assessment being modified so that it will be Page 47 SH Assessment Center administered to the user when they log into the study website Please note this step is not necessary for the baseline assessment Assessment Center Studies instruments Soup Assemble Administration A ee ee eee Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual_Example Advanced Study Setup Create at least one arm assessment instance and click Save You will then be able to click on the Specify Instruments link Save Cancel Window Day 0 Days Specify Instruments Delete Day 100 Days Specify Instruments Delete Day 200 Days Specify Instruments Delete Day 300 Days Specify In
64. cteristics for critical resources confidentiality integrity and availability Secure communication lines are set in place to prevent the interception of data transmission by utilizing various data encryption technologies such as Secured Socket Layer SSL and digital certificates signatures may be used to encrypt data validate data integrity and authenticate the parties ina transaction An infrastructure for confidential data management that includes the sophisticated use of firewall technologies dedicated database and application servers automatic failover design real time monitoring and related technological capabilities has been established Page 79 SH Assessment Center Comprehensive Information Systems IS operating procedures and guidelines which include descriptions of system architecture delivery platform data sharing plan privacy security and issues of ADA Accessibility has been developed Each is presented below in greater detail System Architecture Our web based research application Assessment Center has been developed using ASP NET technology in the CH programming language CH offers rapid development and true object oriented programming While CH is a Microsoft proprietary language Microsoft HP and Intel co sponsored submission of the language specifications to the ECMA for standardization and is currently ratified under the ECMA 334 standard Itis also ratified under the ISO IEC 23270 standard Centraliz
65. d information What if I forgot my Login If you have a Login but cannot remember it contact the Assessment Center Administrator Email helo assessmentcenter net Assessment Center support line 1 877 283 0596 What if forgot my password If you remember your Login but not your password enter your Login and click on the Forgot Password link Assessment Center will automatically email your password to you at the address currently on file in your Login Page 6 Assessmen Assessment Center Resources Instrument Libra Scoring Manuals Workshops Publications Presentations User Manual Terms and Conditions FAO Release History Usage Statistics About Us Video Tutorials Contact Us help assessmentcenter net Help Line 877 283 0596 Support Hours 9 00am 5 00pm CST Monday Friday SH Center WHAT IS ASSESSMENT CENTER Assessment Center is a free online research management tool It enables researchers to create study specific websites for capturing participant data securely Studies can include measures within the Assessment Center library as well as custom instruments created or entered by the researcher PROMIS instruments short forms CATs profiles are a central feature of the instrument library within Assessment Center Any PROMIS measure can be downloaded for administration on paper or be included in an online study Detailed statistical information and development history about PROMIS items and inst
66. d protect secrecy of passwords and log on codes including the use of a non print non display feature Procedures have been established and maintained by Northwestern University to maintain passwords and log in codes All application and network passwords are non printing and non display User level access to Assessment Center is maintained by the Assessment Center team Page 81 SH Assessment Center e Limit the number of unsuccessful attempts to access an AIS or database Intrusion detection is enabled and will lock out user after 5 unsuccessful logins e Develop means whereby the user s authorization can be determined This may include answer back capability Restriction to Assessment Center involves maintaining an encrypted list of current users and authorizations based on permissions and roles assigned to each user Northwestern University provides Assessment Center administrators with secure Virtual Private Network VPN access Operating system and database based permissions are set by the Assessment Center administrators e Ensure that the operating system contains controls to prevent unauthorized access to the executive or control software system Root and administrator passwords are limited to authorized Information Systems administrators User accounts have limited system resource access e Ensure that the operating system contains controls that separate user and master modes of operations Operating Systems in use allow for th
67. data collection The data collection module may be run on any windows PC laptop or tablet PC We currently support Internet Explorer in all the Windows environments The Apple iPad is supported for data collection only Apple iPhone and touch devices Android tablets and handhelds and other mobile devices are not yet supported What does the data collection website look like The Welcome home page of the data collection website contains the welcome message created on the Basic Set up page and default login text When a participant navigates to the website for the first time he or she will click the Start button to begin the assessment The home page contains login and password fields for participants to enter their information so they may complete follow up assessments or complete an incomplete assessment Participants will also enter a login and password if the research team has previously registered them within the Administration tab Once a researcher registers a participant they should provide the participant their login password information so that the participant may enter them on the home page and be immediately navigated to the study instruments Assessment Center Welcome to PRO Manual Example If you already have a Login and Password please enter them in the boxes Login Password If you are a first time user click Start below If you have any questions or problems please contact r hanrahan northwestern edu If you would lik
68. ded Required Fields Only required for consented participants Age 33 DOB o1 14 1965 Gender Y Male Female Ethnicity 22 Hispanic or Latino Not Hispanic or Latino Not Provided White Black or African American Asian American Indian or Alaska Native Native Hawaiian or Other Pacific Islanders y Other LJ Not Provided The Contact Information page contains details of how a participant may be contacted If this information was provided by participants on the registration screens only those variables marked as Include in the Registration sub menu tab will be populated with data It is important to record the first and last name of participants if conducting a longitudinal study as this is the best means of locating registration records when a participant has a question issue or has lost their login password Page 64 SH Assessment Center Assessment Center Studies Instruments Set up tee Administration ie Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 82623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data ha
69. dministration HE GITO E D EEN Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 Study Overview Study AC User Manual_Example2 Goal Participants Accessed Study Registered Started Completed Off Study Refusal 25 3 2 1 0 0 0 To create a new participant registration record click the Find Create Login button To view a list of participants in this study click the Participant List button below Enter participant login then click Find Create Login button Participant List to view an existing participant registration Find create Login NIH Inclusion Enrollment Report Data Dictionary Report Enrollment Report Request and Download Data When your data is available an email notification will be sent to the email below Click buttons to request or download data Please make sure that you are able to accept emails from this site r hanrahanQnorthwestern edu Page 71 Assessment Center SH The data dictionary report is a tool for study analysts The report details all instruments items and provides a list of item IDs and scoring information Data Dictionary UAT215 PROMIS SF Depression 1 0 EDDEP04 In the past 7 days Inclusion Enrollment Report PART A TOTAL ENROLLMENT REPORT Number of Subjects Enrolled to Date Cumulative by Ethnicity and Race felt worthless 1 Never 2 R
70. dorse Terms and Conditions before opening an instrument PDF In future releases you may create PDFs of your custom instruments and submit it to Center Administrators helpo assessmentcenter net for uploading If you do not have Adobe Reader you can download it for free by clicking on the Get Adobe Reader button at the bottom of the page Assessment Center x FR PDF A i My A t Hel t A instruments MEAE E T e di ie ee e Ee Current Study AC User Manual_Example Study Content AC User Manual_Example Study Content Click the Add button to add instruments to your study Click the Create button to create custom instruments in your study Add Save Create You have selected the following instruments for this study Order the instruments by entering the desired position into the text box then click Save To exclude an instrument from your study click on the Include checkbox O Hide Excluded Instruments Study Content Administration Study PROMIS Bank v1 0 Fatigue PROMIS Customize Preview Properties Statistics Notes AC User Manual Example Instrument AC User Manual_Example Customize Preview Properties Statistics Y Notes PROMIS Bank v1 0 Anxiety PROMIS Customize Preview Properties Statistics Y Notes Making Instruments Publicly Available How do I share my instrument with other Assessment Center users You are able to create your own instruments by compiling items within the library or entering new items To m
71. e second portion of the report includes a graph showing scores with standard error bars Page 70 SH Assessment Center Your scores for the instruments you completed are shown below Your SE Score August 20 200 PROMIS 29 Profile 1 0 Report Yourage 50 Your gender Female Anxiety 54 Depressive Symptoms 62 For every questionnaire the average score is 50 in the US general population Fatigue 61 Your estimated score on the Anxiety questionnaire is 64 Your estimated score e m Indicates that your lavel of Anxlaty ls higher worse than 66 percent of people in the general population 60 percent of people age 46 54 61 percent of females Sleep Disturbance Your estimated score on the Depression questionnaire is 62 Your estimated score indicates that your level of Depressive Symptoma is higher worse than 88 percent of people In the general population 23 parcant of people age 45 54 26 percent of females Your estimated score on the Fatigue questionnaire ls 61 Your estimated score indicates that your level of Fatigue is higher worse than 85 percent of people in the general population T8 percent of people age 45 54 21 percent of females Physical Function SS _ _ _ gt e _ _ Satisfaction with Social Your astimated score on the Falin Impact questionnaire ls 56 Your estimated score Roles indicates that your level of Pain Impact is higher worse
72. e event of a power shutdown These units are tested on a routine basis e Ensure that all personnel positions have been assigned security level designations Each Northwestern University s Department of Medical Social Sciences employee receives a pre defined data access security designation based on their employment position The internal security feature of Assessment Center limits these individual s ability to view or access data based on pre defined roles For example only users with the data entry administrator role will have the ability to insert data directly into the repository No Northwestern University s Department of Medical Social Sciences employee with the exception of the database owner s will have the ability to manipulate data directly from the base tables All data manipulations are conducted through SQL views which are also restricted by means of established data access guidelines Any transaction made against Assessment Center is captured by means of an audit trail e Conduct periodic security level designation reviews An audit on the database that controls the card swipe system is performed on a routine basis to review appropriate employee access The results are reviewed by the IS Director The database administrator conducts similar reviews for Assessment Center and will be responsible for keeping an updated employee list e Ensure that all personnel including contractors have received appropriate background investigatio
73. e of a card swiping system and biometric reader on the entrance doors The data center is manned 10 hours a day 5 days a week 260 days a year but access is 24x7 throughout the year e Dispose of unneeded sensitive hard copy documents and erase sensitive data from storage media ina manner which will prevent unauthorized use Unneeded sensitive data on storage media is degaussed from disk drives after the equipment has been taken out of service This procedure is defined in a best practice document Sensitive printed information is disposed of through a bonded document destruction service that performs this service on site at a regularly defined basis Northwestern University s Department of Medical Social Sciences has established standard operating procedures relevant to data retention and removal based on NIH data retention requirements Sensitive participant identifiers of on going studies are encrypted and kept confidential This procedure was initially designed to comply with HIPAA requirements Terminated studies will have all participant identifiers removed from electronic media storage after the retention period Hard copy documents with participant identifiers will be shredded in a timely manner Page 82 SH Assessment Center e Prepare and maintain lists of persons authorized to access facilities and AlSs processing sensitive data All authorized employee access ID s are maintained in a secure database for the badge system that secur
74. e selection All Languages in the default CAT parameters section The parameters defined in this section will be used for any language not defined in an additional language parameters section As in the example detailed above Spanish and French will be administered based upon the parameters defined in the default CAT parameters All Languages section while English will be administered based upon the parameters defined in the additional CAT parameters section Language English see below Page 33 SH Assessment Center Assessment Center PDFs Admin MyA t Help Logout Sip instruments ETT TS min My Accoun cee goes Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization gt gt CAT Parameters CAT Parameters Set Parameters for New Language Save Cancel Instrument AC User Manual Example Instrument IRT Model Graded Response Model CAT Parameters Language English Calibration Sample Promis Wave 1 Item Section Selection Method Max Posterior Weighted Info MPWI Firstltem Select v Theta Item ID Prior Distribution Mean fo Standard Deviation 11 Stopping Conditions Number Of Items Minimum l Maximum 12 Standard Error 0 Information Likelihood Function Theta Lower Bound Fa Upper Bound r Increment 0 May I determine the first item to be administered in a CAT
75. e separation of different classes of users and administrators e Install software feature s that will automatically lock out the terminal if it is not used for a predetermined period of lapsed inactive time and or if a password is not entered correctly after a specified number of attempts Standard timeouts for PC access to systems lock after 10 minutes of inactivity for terminals or 30 minutes for an office PC e Establish controls over the handling of sensitive data including labeling materials and controlling the availability and flow of data The availability and flow of data is limited to the security access identified and signed off by management The availability and flow of participant data in Assessment Center is controlled by the database administrator who will pre define security access levels This will ensure that only data necessary for that individual s work function are viewable All requests are validated before attempting to submit data to the database Any internal or stored reference to a participant is accomplished through a unique identifier key Data is stored and accessed in full compliance with institutional and governmental regulations regarding privacy and security e Require that all sensitive material be stored in a secure location when not in use Sensitive data is stored in the data center Northwestern University has a secure data center that houses all servers This center is limited to authorized employees via the us
76. e to bookmark this page click this Add to Favorites link If the participant has opted to complete the assessment in a non English language see Language section above the Welcome page and all introductory pages will be presented in the specified language The navigation button and messages on item pages will also be in the appropriate language Page 60 SH Assessment Center Assessment Center Welcome to PRO Manual Example Si ya tiene informaci n de acceso y contrase a ingr selos en los espacios correspondientes Informaci n de acceso Contrase a Haga clic en Empezar a continuaci n si usa el sistema por primera vez Empezar Si tiene preguntas o alg n problema comun quese con r hanrahan northwestern edu If you would like to bookmark this page click this Add to Favorites link After the Home page participants will be navigated to applicable online consent forms and the registration pages After these pages have been completed users will receive a system generated login number and password so they may log back into the website to complete future assessments or if they do not complete the current in one sitting The same login and password will be used for all study assessments Assessment Center Click the button below to begin the survey Your participation in the study is appreciated Below is your password for the study Please write down this login and password for your records Your Login
77. ed each item screen but chose to skip it without answering To review or enter participant data click on the applicable assessment then the instrument name This action will open the questionnaire in the main panel of the page The system defaults to presenting all items in a sequential list For CAT instruments all items are listed but only those that were presented to the participant will have a response option selected Item response score and response text will be displayed While response scores are always shown on the Participant Data page scores are only displayed on the data collection website if the Show Response Scores box is checked on the Item Detail page You can use the scroll bar on the right to navigate to see every tem in the instrument If you are entering data using these screens be sure to click on the Save button before moving on to the next instrument To be able to view the Participant Data page staff must have the Study Administrator or Study Participant Administrator roles To be able to modify participant data staff must have the Study Data Entry Administrator role Assessment Center SOTA E CAS a E ae Administration ee E Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Login 16610 Current Study AC User Manual Example 3 Scheduled Events Assessment 1 In the past 7 days I tried to sleep whenever I could 1 Never PROS t
78. ed databases commonly used in data collection have been constructed using Microsoft SQL Server 2008 R2 Direct data access will be allowed only through views and stored procedures and all data changes will be logged In compliance with FDA 21 CFR Part 11 all data will be time stamped and no data will be overwritten thus preserving an audit trail All data transfers will occur through XML files defined by published XML schemas Delivery Platform The internet will provide the primary delivery platform Expertise lies with the Microsoft line of software which will be used to develop the website GUI and backend Study websites will be accessible only through a SSL encryption layer ensuring the confidentiality of the data transferred Study websites will comply with the accessibility guidelines outlined by the World Wide Web Consortium Web Content Accessibility Guidelines 1 0 http www w3 org TR 1999 WAI WEBCONTENT 19990505 These guidelines help promote accessibility by people with disabilities See also ADA Issues below Data Sharing XML is an industry standard method of data sharing The application will implement a standard set of XML schemas for data transfer These XML schemas will be publicly published outlining the format of the data The XML files containing the data itself will be encrypted prior to transport Privacy HIPAA requirements will drive the privacy of data The PHI will be stored separately from the individu
79. egistered for the study Demographic information in this report is pulled from registration information Page 72 SH Assessment Center Study Data Data Entry How can study staff review and enter participant level data The Administration tab allows for a researcher with appropriate permission to review and or enter participant level data from the Participant Data page For example a research assistant in the clinic may want to review a participant s responses to check for missing data or enter data on a clinician rated form The Participant Data page is NOT intended for participant self report or researcher interview The CAT administration engine and customization templates branching randomization are NOT integrated into the Participant Data page The Participant Data page displays a list of all applicable assessments on the left panel of the page Clicking on the name of the assessment will expand the list to show all instruments Text color indicates a participant s progress within the study schedule red indicates an assessments has occurred in the past e the participant is no longer in the defined assessment window green indicates an assessment is currently open and black indicates an assessment is in the future and not currently available If an instrument has line through it the participant viewed all items within that instrument This could mean that a participant responded to all items within the instrument or access
80. elect m Vertical 01 because of your fatigue A little bit Somewhat Quite a bit Very much FATIMP2 In the past 7 days To what degree did your fatigue make you feel slowed down in your Not at all Please Select v Vertical 01 thinking A little bit Somewhat Quite a bit To set parameters for a calibration sample make a selection from both the Language and Calibration Sample drop lists at the top of each CAT parameters section modify default parameters as applicable and click Save The Language drop list is populated with all languages currently supported by Assessment Center The Calibration Sample drop list is populated with all the calibration samples entered on the Item Statistics page for items within the instrument If Page 32 SH Assessment Center the drop list selection made on the CAT Parameters page is not applicable for all items within an instrument the CAT instrument will still run but only administer items which have item parameters for the selected calibration sample Assessment Center et ae instruments MESSA Cote Sa heat an ee a BL Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization gt gt CAT Parameters CAT Parameters Instrument PROMIS Bank v1 0 Fatigue IRT Model Graded Response Model Set Parameters for New Language Save Cancel Language All Languages Calibration Sample Promis Wave 1 y Reset to Default
81. ents Delete Specify Instruments Delete Specify Instruments Delete How does Assessment Center calculate the assessment schedule The assessment schedule for a study is established on the Advanced Study Setup page with the Day Assessment Opens and Window fields A day is based on the Central Standard Time CST Zone That means that if a participant in Chicago begins an assessment at 8pm that is only available that day s he will have until midnight to complete the assessment After midnight the assessment will not be available If a participant is in New York his or her schedule will still be based on Central time even though s he is physically located in the Eastern Time Zone Modify Assessment Schedule How can I change the assessment schedule for one participant In Assessment Center the assessment schedule is set for a study as a whole on the Advanced Set up page Sometimes you may need to adjust the schedule for a single participant This is done in the Administration tab within a participant s individual registration record see steps below Page 46 Assessment Center Assessment Center Studies instruments Set up Assemble Administration Overview Registration Details Participant Details Contact Information Custom Fields Reports To register a new participant enter information below and click Register Participant Login button Please navigate to
82. er to maintain instruments create new instruments and modify existing instruments When your custom instruments are finalized and you wish to add instruments from the master study to other studies access the Instrument Properties page and change the Status field from Under Development to Administered Then you can add these custom instruments to any other study Why would need to break up my project into multiple studies within Assessment Center You may find that you need to have multiple data collection websites and therefore Assessment Center studies for your research plan This happens if you need to administer different consent forms to different participants For example you may have one Assessment Center study with a Lombardi Cancer Center consent form and a second Assessment Center study that is identical in content except that it has a Fred Hutchinson Cancer Center consent form You may also want different URLs if participants are self registering but need to receive different instruments For example one Assessment Center URL may be advertised on a breast cancer support website for a study that includes both global and breast cancer specific measures but a different Assessment Center URL may be advertised on a prostate cancer website for a study that contains the global and prostate cancer specific instruments What should I do when I have completed a study If your data collection and export are complete you have the option to
83. erations Fire Detection and Suppressions The data centers are equipped with either a Halon or FM 200 fire extinguishing systems This system provides a highly effective gas based method of fire suppression that diminishes the risk of damage to computer equipment and storage media that can result from a water based system The data center Halon and FM 200 are maintained under contract with an outside fire systems vendor and are inspected and tested semi annually Flood Control The data center is located above ground with tightly sealed conduits moisture barriers on exterior walls and dedicated pump rooms drainage evacuation systems moisture detection sensors Earthquake The data center adheres to location specific seismic compliance Structural systems meet or exceed seismic design requirements of local building codes for lateral seismic design forces In addition equipment and nonstructural components including cabinets are anchored and braced in accordance with the requirements of the 1997 Uniform Building Code Data Management Systems Security All data collected via Assessment Center will be securely stored at the Northwestern University Research Data Center The following information details how Northwestern University Research Data Center protects its network and all data stored at the Research Data Center The Assessment Center repository is built using the SQL Server 2008 R2 platform The data management environment will meet the
84. es the Building and Data Center doors Access to this database is limited to system administrators and is audited on a regular basis New access requests must be signed off by an IS Director Level or above Only Northwestern University s Department of Medical Social Sciences employees actively participating in the NIH project s will have access to the NIH participant data This is accomplished by system and application level security based on application roles cross referenced with Windows authentication e Establish procedures for controlling access to facilities and AlSs processing sensitive data Authorized personnel s visit to the data center is automatically logged by the biometric key control system Visitors are required to sign a visitor s log and are required to be escorted whenever they are in the Data Center Assessment Center is housed in Northwestern University s Data Center e Furnish locks and other protective measures on doors and windows to prevent unauthorized access to computer and support areas The Operations Center has limited access to unauthorized employees via the use of a card swiping system and biometric reader on the entrance doors The data center is also manned 10 hours a day 5 days a week 260 days a year but access is 24x7 throughout the year After hour entrance to the building is also on a card swipe system e Install emergency panic hardware on Emergency Exit doors ensure that emergency exits are appropriately m
85. ese are date of birth doctor last name first name street city state zip email phone 1 and phone 2 When a data field is marked as containing PHI all data collected in this field will be flagged in the database and will be reported as containing PHI in applicable data exports This feature is intended to aid in de identification efforts and protect participant privacy The Ethnicity and Race fields utilize responses recommended by current NIH guidelines For Ethnicity participants indicate if they are Hispanic or Latino Not Hispanic or Latino or Not Provided For Race participants can select all that apply American Indian or Alaska Native Asian Black or African American Native Hawaiian or other Pacific Islander Not Provided Other and White If this information is collected in registration it will automatically populate an NIH Inclusion Enrollment report that meets the criteria for NIH progress reports There are five custom registration fields They are organized based on response type One field allows collection of a date response e g date of diagnosis There are two fields to collect numeric responses e g number of hospitalizations in the last year A custom text field allows for open text responses e g name of hospital Finally a custom list registration field presents a drop list e g type of cancer breast colon lung etc For this customizable field responses must be entered in the validation section and be separ
86. essment Centeris provided for use by the clinical research community without charge Additional information about use is available in the Terms and Conditions document https www assessmentcenter net TandC aspx As an Assessment Center user adherence to the Terms and Conditions guidelines is required Security What security exists for Assessment Center Assessment Center utilizes multiple layers of protection for its users First it uses role based permissions The study creator decides who to add to the study team and assign each member the appropriate level of permission Team members will be able to view information in your study based on their roles Assessment Center users that are not part of the study team will not have access to any study information or participant data New team members are automatically assigned the role of Associate this role has read only access to study elements To reassign roles select a team member s name and then check the Role box s that best identifies their responsibilities within the study The only roles that will be able to view participants data and personal health information are Study Administrator study creator s default role Study Participant Administrator Study Data Entry Administrator and Data amp Statistics Administrator It is important to be very cautious and thoughtful when assigning these roles Only the Study Data Entry Administrator may edit participant data while only the Data
87. f Treatment_Regimen ne then do treatmenta band Treatment_Regimen 1 gt 0 treatmentb band Treatment _Regimen 2 gt 0 treatmentc band Treatment _Regimen 4 gt 0 treatmentd band Treatment _Regimen 8 gt 0 end Page 76 SH Assessment Center Protected Health Information PHI Is there Protected Health Information PHI in data exports Any data export could contain PHI based upon the data fields included in your study If include in a study the system will flag the following registration fields as containing PHI in data exports date of birth doctor last name first name street city state zip email phone 1 phone 2 will always be marked as containing PHI Users may choose to flag other fields as PHI i e any custom item consent endorsement text fields and certain custom registration fields When a data field is marked as containing PHI all data collected in this field will be flagged in the database and will be reported as containing PHI in applicable data exports In applicable data export PHI fields True indicates a PHI checkbox was endorsed by study staff during set up This feature is intended to aid in de identification efforts and protect participant privacy Data exports can only be accessed by study team members with appropriate permissions However once the data is exported outside of Assessment Center the user is responsible for adopting security measures and regulations Help What shou
88. f you require item specific variations of the same response option please contact helo assessmentcenter net to review alternatives Within the translation file export Translation is the only field which may be modified No changes are allowed in the instrument name language item ID and description fields If you change any of these fields you will receive errors when importing the file back into Assessment Center Page 23 W0 TDW wine 0 JO 0 2 w Nje 9 A PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example PRO Manual Example E Context Response Option Response Option Response Option Response Option Response Option FATEXP19 FATEXP20 FATEXP22 FATEXP26 FATEXP6 FATIMP16 Context Response Option Response Option Response Option Response Option Response Option FATEXP20 FATEXP22 Assessment Center In the past 7 days Always Never Often Rarely Sometimes How often were you physically drained How often did you feel tired How often were you bothered by your fatigue How often were you too tired to enjoy life How often did you feel tired even when you
89. ften Always Buttons01 also displays response options vertically but has the response text printed on a large button When a participant clicks anywhere on the button to select it the button becomes to yellow Because this template has a larger selection area it may be helpful for populations with less fine motor control e g children physically impaired Please rate how you feel you are doing today compared with how you were doing at your last study assessment Somewhat better Page 30 SH Assessment Center The Cartoon templates mimic either the Vertical 01 or Buttons 01 templates with the inclusion of a cartoon image This template is intended to be used with children or other similar populations to put them at ease and encourage them during an assessment What is your level of pain right now No pain Mild Moderate severe Very severe Horizontal01 displays response options horizontally with radio buttons The Horizontal 01 templates are only an option in the Template drop list for multiple choice items Horizontal 01 templates may only be selected on the item level Therefore they do not appear as an option on the Change all item templates to drop list Response scores are displayed in data collection when the Show Response Score box in checked on the Item Detail page In the past 7 days How would you rate your pain on average No Worst pain pain imaginable Page 31 SH
90. functioning correctly a researcher may want to be able to access follow up assessments on the same day as the baseline assessment Or a participant may be granted an extension of the assessment After clicking on the View Schedule Details hyperlink a pop up window with the participant s assessment schedule will appear Assessments that are currently open are green Assessments that are past due are red Assessments that are in the future are gray Start and end dates are displayed The span between start and end date corresponds with the Window variable entered on the Advanced Study Set up page To implement a date change first enter the new date and then click the pencil icon to the left of the row It is necessary to modify one row at a time Note that each assessment has a row labeled Participant View and a row labeled Clinician View You will want to change both rows Participant Schedule 06 20 2009 06 24 2009 08 20 2009 MN 08 24 2009 Page 69 SH Assessment Center Participant Reports What participant level reports are available Studies that include a PROMIS Profile instrument or a subset of adult PROMIS CATs will automatically generate single time point reports for each participant These reports are located under the Reports sub menu tab The date an instrument was completed is listed as a hyperlink click to open the report If no PROMIS v1 0 CATs or Profile instruments were included in your study this page will be
91. goal was to identify 6 8 items that represented the range of the trait and also represented the content of the item bank Domain experts reviewed short forms to give input on the relevance of each item Each domain group worked independently and the original short forms are 6 10 items long Psychometric properties and clinical input were both used and likely varied in importance across domains Later PROMIS Profile instruments were developed The PROMIS Profile Instruments are a collection high information PROMIS short forms for seven domains Anxiety Depression Sleep Disturbance Fatigue Pain Interference Impact Physical Function and Satisfaction with Participation in Social Roles Three PROMIS Profile Instruments were created in which 4 item 6 item or 8 items were selected from each domain The items within each instrument are nested overlap e g the 8 item form is the 6 item form plus two additional items The selection of items was in part based on two sets of item rankings within each domain using two psychometric criteria 1 maximum interval information and 2 CAT simulations Item rankings were similar for both criteria For the maximum interval criterion each item information function was integrated without weighting for the interval from the mean to 2 SDS worse than the mean For the CAT simulations responses to all items in each bank were generated using a random sample of 1 000 simulees drawn separately for each bank ce
92. gt gt Instrument Customization Instrument Customization Instrument AC User Manual Example Instrument Set IRT Parameters Instrument order is Branched Define Branch criteria below Randomize Item Blocks Randomize Items within Item Blocks Templates determine how an item will appear to study respondents on the data collection screens Change all item templates to Item Block gt Number Branching If Then Go To Template ACUM_4914 Inthe past 7 days I felt very tired Not at all FATIMP20 v Vertical 01 A Little bit Somewhat Quite a bit Very much Please select FATIMP15 In the past 7 days How often did your fatigue interfere with your ability to engage Please Select Vertical 01 in recreational activities Page 29 SH Assessment Center Templates What templates are available in Assessment Center There are five item templates Vertical 01 Buttons 01 Cartoon Harry 01 Cartoon Harry Buttons 01 and Horizontal 01 All templates have an Auto Advance version as well which uses the same format but navigates a participant to the next item as soon as a response is selected Vertical 01 displays responses in a vertical list with radio buttons A participant can click on the radio button or the response word s to select his her choice This is the default template in Assessment Center In the past 7 days How often did you feel tired 5 Never Rarely Sometimes O
93. he text they would like accompany these fields e g Please check this box if you agree to participate within each consent language section Users may opt to use one both or none of these endorsement indicators although IRBs may have institution specific requirements that may guide a user s decision The endorsement field will appear at the bottom of the consent form when presented to research participants If you are collecting data in multiple languages you should include a consent form in each language Consent forms within Assessment Center are for online use only Do not use this feature if you intend to obtain informed consent with paper based forms Consent status is recorded within a study participant s registration record Registration Details page within the Administration tab and Export Consent Data export Page 52 SH Assessment Center Language Basic Advanced Consent Registration Current Study ACUM_R8 5 Consent ACUM_R8 5 Consent Forms To add up to three consents forms to your study expand applicable consent boxes and enter information E Consent 1 Include W E Consent contains Protected Health Information PHI E Include an endorsement checkbox de an endorsement text entry Endorsement checkbox text Endorsement text entry text I accept Please type in your name Please copy and paste your consent form content into the box below 9 size B Ar A a Consent 2 Include W When are consent fo
94. her The instrument library includes self and proxy report short forms computerized adaptive tests CATs and batteries or profiles from Request PDFs of J j ON a Patient Reported Outcomes Measurement Information System PROMIS PROMIS Short Forms a Quality of Life in Neurological Diseases Neuro QOL a NIH Toolbox Publications Presentations User Manuals os Among other important features Assessment Center also enables Sponsors Downloading library instruments for administration on paper Customization of items or instruments e g format randomization skip patterns Real time scoring of CATs and short forms Neuro OOL FAO Storage of protected health information PHI in a separate secure database Automated accrual reports Real time data export Ability to capture endorsement of online consent forms PROMIS Terms and Conditions NIH Toolbox Release History Studies of Interest Usage Statistics PROsetta Stone About Us ANNOUNCEMENTS Video Tutorials Contact Us help assessmentcenter net Help Line 877 283 0596 2007 2013 David Cella Ph D Additional PROMIS Instruments now available in Spanish See the Instrument Library link at left to see what PROMIS instruments are available in Spanish New PROMIS Computer Adaptive Tests for Upper Extremity Function and Mobility Physical Function can now be assessed specifically for upper or lower body function The full Physical Function CAT remains available
95. hich an instrument was created To learn more about publically available instruments access the Assessment Center Instrument Library document http assessmentcenter net documents InstrumentLibrary pdf As of January 2013 NeuroQOL Quality of Life in Neurological Disorders item banks which are enabled for Computer Adaptive Testing CAT and NeuroQOL short forms are publicly available in Assessment Center As with PROMIS instruments they will appear by default on the Add an Instrument page More information about NeuroQOL may be found at www neuroqol org What are the PROMIS Profile instruments PROMIS Profile instruments are short forms containing items from seven of the PROMIS domains depression anxiety physical function pain impact fatigue sleep disturbance and satisfaction with participation in social roles The PROMIS 29 includes 4 items from each domain plus one pain intensity item The PROMIS 43 includes 6 items from each domain plus a pain intensity item The PROMIS 57 includes 8 items from each domain plus the pain intensity item When a study participant completes a Profile instrument an individual functional report is created see Reporting section below What is the difference between PROMIS short forms You will notice that there are several versions of many of the PROMIS short forms e g the original 1 0 short form as well as the 4a 6a and 8a versions The original short forms were constructed by the domain teams The
96. his time Assessment Center may be unavailable We apologize for any inconvenience this may have If you have any questions please contact us at help assessmentcenter net Several registration elements are required to be unique across Assessment Center i e the registration elements cannot already exist in Assessment Center These elements include Login and the combination of last name first name and institution If another user has already registered with the same combination of last name first name and institution you must change at least one of these three registration elements Assessment Center Registration step 1 Please complete fields below Password Re enter Password Title First Name Last Name Institution Email Re enter Email Phone Mailing Address City State Province Please Select y Country Postal Code Single Sign On ID Page 5 Assessment Center You are required to agree to the Assessment Center Terms and Conditions The terms and conditions will appear in a pop up window once you have clicked Save on the User Registration page You will want to review the entire document and then click on the Accept button to move forward The Assessment Center Terms and Conditions address issues related to software security use and copyrights You will also be required to a
97. ications have been made after this date click the PREVIEW button Be sure to review your data exports on the Administration tab prior to launching your study Click the Preview sub menu tab to access the Preview Study page To initiate the preview click on the Preview button The system will launch your study for preview The preview launch pop up will indicate the launch is Page 56 SH Assessment Center complete and after you have clicked the Continue button you will be navigated to your preview data collection website The data collection pages will have a Preview watermark only while in preview mode Assessment Center Welcome to PRO Manual Example If you already have a Login and Password please enter them in the boxes Login Password If you are a first time user click Start below If you have any questions or problems please contact r hanrahan northwestern edu Complete all assessments to ensure everything is working as intended If study configuration is not as expected or if an instrument item or study parameter is identified as needing modification you will need to make the appropriate modifications within the Instruments or Set up tabs Most study parameters e g add create instrument item create study arm instrument order etc may not be modified once the study has been launched Therefore it is essential to make any applicable revisions prior to launching your study If you have problems
98. ig Assessment 2 1Form s PROMIS Bank v1 0 Sleep Relsted Impsirment Rarely a 4 5 PROMIS Bank v1 0 Pain Behavior PROMIS Bank v1 0 Fatigue PROMIS SF v1 0 Depression 8b Assessment 3 Sometimes Often Always In the past 7 days My daytime activities were disturbed by poor sleep 4 2 3 4 5 Never Rarely Sometimes Often Alwavs Save Page 73 SH Assessment Center Response Tracking How can research staff track participant responses to identify at risk responses A researcher may want to track responses to specific items in a timely manner over the course of a study please see previous topic to understand how to access participant data For example a researcher may want to identify responses that may indicate a participant is experiencing thoughts that may result in self harm or harm to other people The first step in tracking participant s at risk responses is to identify which instruments within your study contain items which have concepts e g suicidal ideation that should be monitored Research staff should be instructed to review a participant s response to such items after each assessment Intervention thresholds should be established by the research team prior to the start of the study e g response of quite a bit or very much to the tem have thought about suicide will result in the research staff contacting available mental health staff Research
99. ing to the instrument and its items that will help you determine if you would like to include the instrument in your study Page 13 SH Assessment Center Are additional instruments required when using NIH Toolbox instruments batteries All NIH Toolbox instruments were normed by level of education Therefore when any NIH Toolbox battery or instrument is added to your study an education instrument will automatically be included The education instrument MUST be administered prior to the NIH Toolbox instruments in order for accurate scoring to occur For example in language tests education level determines where to begin the presentation of items For children under the age of 18 a second education instrument about parental education is included Parental education was used in norming for this age group Additionally some instruments Cognition Motor were normed for use of one s dominant hand Depending on the battery or instrument a handedness instrument may be included automatically This instrument includes a series of questions e g what hand is used to write to throw a ball if the respondent doesn t know the dominant hand The handedness instrument should be administered prior to the NIH Toolbox instruments If you are selecting individual NIH Toolbox instruments rather than using an entire battery Assessment Center will automatically include the education and handedness instruments where needed Finally a couple regi
100. irst line and the item stem appears on the second line If an item that is just one sentence or should be displayed as one statement enter the text into the stem field only Item Response Types What are the available item response types There are eight different item response types available within Assessment Center One response option informational should be used when an item has no text or scores applied to the response section This type should be used for items that give participants additional information such as additional instructions or text transitioning participants from one concept to another Four of the response options have a pre determined format text numeric date and comments This means that a participant will be presented with a field to type text a small field for text and a larger field for comments a number or be prompted to enter a date using drop lists for month date and year The comments response type can be utilized to obtain qualitative data and feedback Two other response options multiple choice and drop list need user defined scoring and response text e g 1 Not at all A final response option checkbox is similar to a multiple choice item although it allows more than one response to be checked e g indicating more than one race The scoring for this response type is system generated and can be found in the Data Dictionary report within the Administration tab once a study has been launched These final
101. ite per participant population For example you could create one study website for breast cancer patients and one study website for prostate cancer patients How do create study arms that have an unequal number of participants If you are having participants self register they will be automatically assigned to a study arm in EQUAL numbers This is appropriate if you want say 100 people in Arm A and 100 people in Arm B If you have uneven group sizes you can create multiple arms that are identical For example in a given study you may want 300 people in Arm A but only 100 people in Arm B You can create four arms Arm Al A2 and A3 are all identical to each other and Arm B is different Equal numbers of participants are assigned to each arm and as a result you will have 300 people in the A arms and 100 people in the B arm Page 44 SH Assessment Center Study arm assignment can be summarized from the Registration Data export Study Arm appears as column AB when the export is opened in Excel If your study has specific accrual goals per study arm it will be important to periodically run the export and assess the number of participants in each arm Create Multiple Assessments How do I set up a longitudinal study Assessment Center allows for data collection at multiple points in time For example a researcher may want to collect initial baseline data a 1 month and 6 month follow up This can be accomplished through the Assess
102. l able to eliminate an item being administered twice The Administer drop lists allow a user to specify whether or not they would like the system to check if an item has already been administered in an assessment and if that is the case not administer the item on a subsequent instrument within the same arm assessment If a user selects No Duplicates under the Administration field any item already administered in the preceding instruments will not be administered a second time The score recorded when the item was first administered will appear in the export files for both instruments The Mode field in the Assessment Data export will indicate if the participant s response was captured for that instrument Participant via Web or copied from a prior instrument Algorithm System Generated The administration of All Items is the default An Administer selection is not available if an instrument is using a non sequential administration engine i e CAT branch random Assessment Center Studies i instruments i Assemble Administration O a Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual Example gt gt Specify Instruments Arm Assessment Details Arm default Assessment 1 Save Back Instruments can be blocked These blocks can be administered randomly or in a fixed order Instruments in the same block are administered together in a random or pre defined order
103. ld I do if I am having problems with Assessment Center Assessment Center includes a Help feature which can be accessed at any time via the link in the top right corner of the application The organization of Help parallels that of Assessment Center Help includes field definitions explanations of how to complete particular tasks tips and additional useful information Help opens into a second window to allow the user s work to not be disturbed while seeking additional information Users may also contact center administrators at helo assessmentcenter net or 1 877 283 0596 for assistance or access further Assessment Center technical documentation e g FAQs Scoring Manuals from the Assessment Center homepage http assessmentcenter net Requirement Questions What information should I know about my study before setting it up in Assessment Center It is helpful to know your study protocol before attempting to set up a study specific website in Assessment Center Information you should know includes 1 What instruments are in my study Study Content page 2 Are any instruments included that are completed by someone other than the participant e g clinician rating Arm Assessment Details page 3 How are responses for each item scored Item detail page 4 How should items appear on a computer screen to participants template Instrument Customization page 5 How are items ordered Sequential Branched Randomized Grouped together
104. le soreadsheet will be protected Therefore to Page 24 SH Assessment Center make modifications to the Translation column you need to first unprotect the spreadsheet In Excel this is done by accessing the Review tab and clicking Unprotect Sheet It is important to note this action will unprotect all fields You must take caution to only modify the content within the Translation column Modifications to content in other columns will prevent a successful import of the translation file Once you have made the desired modifications to your translation file navigate to the Instrument Detail page and click Import This will initiate the process of uploading the modified translation file Are any public instruments available in other languages Yes several of the public PROMIS instruments are available for administration in Spanish via Assessment Center Please refer to Table 1 within the Assessment Center Instrument Library document located here http assessmentcenter net documents InstrumentLibrary pdf for more detailed information Am l able to upload translations of items from publicly available instruments Item translations are associated with an instrument You may not make edits to item translations for public instruments any other custom instruments which have already been launched for data collection or not yet launched instruments for which you do not have appropriate permissions However once you have added an item from a p
105. lick Export and choose Save Language File Name Date of Upload Spanish No translation file currently exists for this language N A instrument Detail ID Responses Administration Study Include ACUM 4914 In the past 7 days I felt tired Not at all AC User Manual_Example History Statistics Y Notes Upload Item Translations 1 Navigate to the Instrument Detail Page Click Upload Translations button Make selection from Language drop list Click Export button within Translation box Save translation file soreadsheet to your computer Open translation file soreadsheet Enter appropriate translations into Translation column Save translation file changes Click Import button within Translation box 10 Select appropriate translation file 11 Verify File Name and Date of Upload fields have been updated OPNDNPWN Once you click on Export you will be prompted to download an Excel file This file includes columns containing instrument information i e instrument name default language etc and item elements e g item ID item stem response text etc A column titled Translation is where you will type or copy paste in the direct translation of the content in the corresponding Description field The Description column will contain all items context and stem together and all response options included in the instrument You will only need to enter a translation for each response option once even if it is used for multiple items within the instrument I
106. making corrections please contact administrators at helo assessmentcenter net or 1 877 283 0596 How do create preview test logins When previewing a study you will first have to self register a participant by clicking the Start button on the Welcome page After the initial preview you can create additional pins to test different arms and time points Go to the Administration tab and click the Find Create Login button This will navigate you to a blank registration page Complete all applicable fields be sure to select Preview from the Consent Obtained field and then click the Register Participant button This will register a test participant You may then navigate to the study s data collection preview site and complete the assessment as a participant Please note there are some instances in which it may be necessary to review test a data collection website after a study has officially been launched into data collection A specific example is when administering Toolbox Page 57 SH Assessment Center instruments batteries In order to learn how to administer NIH Toolbox instruments it is strongly recommended that you practice prior to working with a patient participant It is easiest to do this in the study you plan on using for actual data collection To ensure preview test data is not included in the dataset you will later use for analyses you must flag these logins as Test participants To do so after you have
107. ment Day Assessment Opens and Window fields Enter the assessment number in the Assessment field The Day Assessment Opens field indicates when an assessment is made available to study participants This information is not relevant to the first baseline assessment and no data will be entered in this field when the Assessment field equals 1 For subsequent assessments enter the number of days after the first assessment that you want the assessment to be available In the example below the 1 week follow up would be 7 days after baseline and the 2 week follow up would be 14 days after baseline The Window field establishes how many calendar days an assessment will remain open to study participants For example if participants have one week to complete the assessment enter 7 in the Window field A study participant may exit the assessment and return at a later time as long as it is within the assessment window In the example below Assessment 2 will be open from Day 7 to Day 9 Assessment 3 will be open from Day 14 to Day 16 It is recommended that you do not have overlapping assessments If you do a person would be immediately transitioned to from one assessment to the following assessment Assessment Center Studies instruments Setup Assemble Administration ee ee oe ns Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual_Example Advanced Study Setup Create at least o
108. ments included in the study are listed Select Not Included under the Instrument Block field for any instrument within your study that you do not want administered for this arm assessment Assessment Center Studies Instruments Set up BC SU e eee Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual Example gt gt Specify Instruments Arm Assessment Details Arm arm1 Assessment 1 Save Back Instruments can be blocked These blocks can be administered randomly or in a fixed order Instruments in the same block are administered together in a random or pre defined order Instrument Block Block Administration Instrument Order within Block Completed by Participant Administer 1 M Fixed Y PROMIS Bank v1 0 Fatigue Y CAT Not Included Y Fixed Y AC User Manual Example Instrument l Y All items Y 4 v Fixed Y PROMIS Bank v1 0 Anxiety CAT Instrument Order How do I define the order of instrument administration for each arm assessment Instruments can be grouped together for administration For example you may wish to group sociodemographic instruments or patient reported outcome instruments together On the Arm Assessment Details page each instrument can be assigned to a group using the Instrument Block field For example all sociodemographic instruments could be assigned to Instrument Block 1 and all patient
109. ms to have in your study For example if you have a study design in which different people are getting different measures you will want to have multiple arms How do participants get assigned to a study arm If participants self register i e access the study specific website enter registration or consent information and obtain a login they are assigned to a study arm by Assessment Center Generally this works for item calibration testing when you don t need to control who answers what instruments items However this is not appropriate if you want for example all patients with breast cancer to get one set of instruments and patients with prostate cancer to get a different set of instruments If you need to direct participants to a specific arm researchers should register the participants from the Administration tab assigning each participant to the correct arm This means that participants will enter their login and password information on the Welcome home page of the data collection website By doing so they will bypass the registration and consent screens Therefore it is important for the researcher registering the participant to collect all applicable registration data and consent the participant or verify consent has been obtained If participant registration by a researcher is not feasible e g participants will complete assessment at home after receiving a newsletter you can set up a study and subsequently a data collection webs
110. mum 10 000 characters re English Accrual End Date 4 7 2015_ Close data collection when sample size 25 equals Contact information for participant questions r hanrahan northwestern edu Welcome to AC User Manual_Example a https msswebtest fsm northwestern edu assessmentcenter qa ac1 Assessments URL Extension AC_User_Manual_Exa French May include an image on my study s home page An image can be uploaded to Assessment Center for inclusion on your study websites home page To begin the upload process click on the image icon within the Login Screen box toolbar An Image Properties window will open Within this window navigate to the Upload tab and Browse your computer for the appropriate image Once the image is found click the Send it to the Server button to complete the upload You will receive a confirmation message To finalize the upload click Ok on the Image Properties window and you will then see the image within the login screen page Page 42 Assessment Center PDFs Admin MyAccount Help Logout ser Manual Example Image Properties Image Info Link Upload Advanced URL Save Cancel 9 00C 3 Alternative Text Width Preview Lorem ipsum dolor sit amet consectetuer 25 Height adipiscing elit Maecenas feugiat consequat diam gt Maecenas metus Vivamus diam purus cursus a commodo non facilisis vitae nulla Aenean dictum r hanrahan northwestern edu
111. n on the tabs at the E bottom of the Excel window Select and copy all fields from the PivotTable you Figure 1 Source Name Score Summarize value field by Choose the type of calculation that you want to use to summarize the data from selected field A Defer Layout Update Update wish to keep in your final data set and then paste them into the new worksheet You can now save the final data set in the format you wish to work with xls csv txt etc by selecting Save As from the menu in the upper left corner of the Excel window Figure 3 When I include checkbox item how do I unbundle the bitwise value in the data export Bitwise values are used for checkbox items Each response is assigned a numeric value i e 1 2 4 8 16 32 64 etc These values are summed and the total is stored as the score for the item ID Therefore if a participant has a score of 9 you know that he or she endorsed the first and fourth responses scores 1 and 8 summed For statistical analyses you will need to unbundle this summed score and create additional variables to indicate if a participant endorsed the first response yes no second response yes no and so on In SAS you can use the BAND bitwise logical AND operator function below In this example below we have a checkbox item named Treatment_Regimen The response choices are Treatment_A Treatment_B Treatment_C and Treatment_D i
112. nced sub menu tab please review the Arm Assessment Details page then contact administrators at help assessmentcenter net or 1 877 283 0596 Should I conduct other reviews before previewing my data collection site A study summary is displayed on the Build Study page detailing the accrual goal start date end date study URL and contact information Also after you initially launch your study for preview the Administration tab is available for use Navigate to the Administration tab to review participant registration and data pages study reports and data exports Page 55 SH Assessment Center Assessment Center SS o RIE CR F i Studies instruments Set up Administration o is o Build Preview Launch Current Study AC User Manual_Example Build AC User Manual_Example BUILD STUDY Assessment Center must assemble study files before creating a preview version of your study Study files must be collected and assembled the first time a study is previewed or anytime changes are made to a study To collect and assemble the study files click on the BUILD button Warnings and Error Messages There are no warnings or errors found in your study Study Configuration Export View Export The export contains details of your study set up as entered on the Advanced set up tab e g study arms instrument blocks per arm assessment administration engine etc y Accrual Goal 25 Go there 9 start Date Apr 7 2014 12 00AM G
113. ndorsement type endorsement text addition deletion of registration fields addition deletion of required status for registration fields and changes to registration field validation After saving any of these modifications it may be necessary to re launch the study from the Launch Study page so that the modifications are applied to the data collection website Note that changes cannot be made to instruments after a study has been launched for data collection Therefore it is highly recommended an extensive review of instruments and items is completed using the Preview feature Why can t I modify a launched study Based on end user feedback Assessment Center does not allow revisions to study content Researchers requested that the system preserve the integrity of a study so that at the time of analyses it would be obvious exactly what instruments a participant completed rather than having to identify the time of completion and the study version that was available at that time For this reason it is critical to review the Study Configuration Report and preview your study prior to launch Page 59 SH Assessment Center Study Specific Data Collection Website How can l access my data collection website Once a data collection website has been generated you may navigate to it by either clicking on the link at the top of the Launch page or typing in copying the web address directly into your internet browser What devices may I use for
114. ne arm assessment instance and click Save You will then be able to click on the Specify Instruments link Save Cancel Assessment Day Assessment Opens Window Control 1 Day 0 2 Days Specify Instruments Delete Control 2 Day 7 2 Days Specify Instruments Delete Control 3 Day 114 2 Days Specify Instruments Delete Intervention Day o Days Specify Instruments Delete Intervention Day 7 Days Specify Instruments Delete Intervention Day 14 Days Specify Instruments Delete How do I set up a daily assessment To create a study that has a daily assessment enter 0 in the Window field A participant will have until midnight central standard time CST to complete an assessment for that day In the example below a participant is asked to complete an assessment every day for 7 days Page 45 SH Assessment Center Assessment Center E PDF i el Studies instruments Set up Assemble Administration A A ea ee Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual_Example Advanced Study Setup Create at least one arm assessment instance and click Save You will then be able to click on the Specify Instruments link Assessment Day Assessment Opens Window 1 Specify Instruments Delete 2 Specify Instruments Delete 3 Specify Instruments Delete Specify Instrum
115. ng the correct amount of money when making purchases NOCOG22 How much DIFFICULTY do you currently have reading and following complex instructions e g directions for a new Statistics Statistics Statistics Statistics View Statistics Pages How do l use Statistics pages Another way you may learn more about an instrument and its items is to review the Instrument and or Item Statistics pages These statistics pages are accessed by clicking on the Statistics hyperlinks For instruments the Statistics hyperlink is visible on the Study Content and Add an Instrument pages For items you must expand an instrument using the plus symbol to see each item along with its Statistics hyperlink The statistics pages contain data analyzed in previous studies allowing you to review how an instrument and or item performed in previous analysis The data entered here has been entered by other Assessment Center users As a user you may enter statistical information for instruments and items you create If you are interested in contributing additional statistics to Public instruments contact the Assessment Center Administrators at helo assessmentcenter net or 1 877 283 0596 Assessment Center ETT instruments eee Coon a tr ee ee ee a Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Add an Instrument Add an Instrument First select instrument or battery a fixed set of instruments Use
116. ns All IS employees and contractors have received background investigations All Northwestern University s Department of Medical Social Sciences employees have had proper background investigations conducted by the human resource department Acknowledgement of Security Requirements A detailed outline of our present and proposed Information Technology systems security program are outlined above and demonstrate compliance with the AISSP security requirements of the Computer Security Act of 1987 Office of Management and Budget OMB Circular A 130 Appendix III Security of Federal Automated Information Systems and the DHHSAISSP Handbook at or above the minimum requirements of a Security Level Designation 2 identified in the DHHS AISSP Handbook Exhibit III A Matrix of Minimum Security Safeguards Page 84
117. nt Center Studies instruments Set up Assemble Administration PaRi Ced a ee e Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual Example gt gt Specify Instruments Arm Assessment Details Arm default Assessment 1 Save Back Instruments can be blocked These blocks can be administered randomly or in a fixed order Instruments in the same block are administered together in a random or pre defined order Instrument Block Block Administration Instrument Order within Block Completed by Participant Administer Fixed Y PROMIS Bank v1 0 Fatigue Y CAT Fixed Y AC User Manual Example Instrument No Duplicates Y Fixed Y PROMIS Bank v1 0 Anxiety Y CAT How do learn more about the instruments in my study There are three hyperlinks for each instrument on the Study Content page These links offer users information about each instrument One of these links is the Statistics link which was also available on the Add an Instrument page The other two are Properties and Preview The Properties link provides detailed information about each instrument This page is view only for administered and public instruments The Preview link opens a pop up screen that will display an instrument in a selected template in any applicable language and if selected will display information about item administration and selecti
118. nter net Your password must be at least six characters You may use any combination of letters numbers or special characters to create a password To complete the registration process you must log into Assessment Center Once you have created a registration record enter your Login and password on the homepage and click Continue After you have logged in at least once your name will appear on the Assessment Center user list and you may be included as a team member on any applicable Assessment Center study Page 4 Assessment Center Assessment Center Resources Instrument Libra Scoring Manuals Workshops Publications Presentations User Manuals Glossary Terms and Conditions FAO Release History Usage Statistics About Us Video Tutorials Contact Us helpG assessmentcenter net Help Line 877 283 0596 O 2007 2013 David Cella Ph D WHAT IS ASSESSMENT CENTER Assessment Center is a free online data collection tool that enables researchers to create study specific websites for capturing participant data securely online Studies can include measures within the Assessment Center library as well as custom instruments entered by the researcher The instrument library includes self and proxy report short forms computerized adaptive tests CATs and batteries or profiles from a Patient Reported Outcomes Measurement Information System PROMIS a Quality of Life in Neurological Diseases Neuro QOL a NIH Toolbox Among
119. ntered on 0 5 SD worse than the general population mean Items were rank ordered based on their average administration rank over the simulees Content experts reviewed the items and rankings and made cuts of 4 6 and 8 items How should I determine which instrument to use In selecting a short form the difference is really the instrument length The reliability and precision of the short forms within a domain is highly similar If you are working in a sample in which you expected huge variability in a domain area and wanted different subdomains covered you would probably go for the original short form If you are Page 16 SH Assessment Center working with a sample in which you wanted the most precise measure you would go for an 8a short form If you had little room for additional measures but really wanted to capture something as a secondary outcome you would go for a 4a short form What instruments for children are available in Assessment Center Currently PROMIS calibrated item banks which are enabled for Computer Adaptive Testing CAT and short forms for children ages 8 to 17 are available in Assessment Center These instruments may be selected for use in a study There are also a set of NeuroQOL items banks enabled for CAT and short forms available for pediatric populations To learn more about publically available instruments access the Assessment Center Instrument Library document http assessmentcenter net documents In
120. o there E End Date Apr 7 2015 12 00AM Go there y Languages of Administration English Go there How do l initiate a preview of my study s data collection site Once you have reviewed the report you will want to preview your study from the perspective of a participant The preview will show all study details e g language items instruments administration engines instrument blocks per arm assessment etc Preview also allows you to review scoring of instruments If you would like to view response scores during preview ensure Yes is endorsed on the Preview Study page It is important to note you will not need to change your endorsement to ensure response scores are not displayed to participants The only instance in which response scores will be displayed to participants once a study is launched is if the Show Response Score boxes are checked on the Item Detail page Assessment Center Studies Instruments Setup ccculsca Administration o ergs ahs mrnsing Build Preview Launch Current Study AC User Manual_Example Preview AC User Manual_Example PREVIEW STUDY Select YES to review item response scores during study preview This will only be enabled during study preview y gt a Ready to preview your study This study was last built on Apr 7 2014 2 22PM If you have modified your study after this date navigate to the Build page and click Build Once your study has been re built click the PREVIEW button If no modif
121. on Assessment Center MPA instruments MAP Conan a Unrate eh So eee Togu Current Study AC User Manual_Example Study Content AC User Manual_Example Study Content Click the Add button to add instruments to your study Click the Create button to create custom instruments in your study Add Save Create You have selected the following instruments for this study Order the instruments by entering the desired position into the text box then click Save To exclude an instrument from your study click on the Include checkbox LJ Hide Excluded Instruments Study Content Name Administration Study Include PROMIS Bank v1 0 Fatigue PROMIS Customize Properties Statistics AC User Manual Example Instrument AC User Manual_Example Customize Preview Properties Statistics PROMIS Bank v1 0 Anxiety PROMIS Customize Preview Properties Statistics Instrument Preview What is the purpose of previewing instruments The Preview link shows what an instrument looks like in various administration templates It includes all items in an instrument Selecting the Preview hyperlink will display a View Options popup box from where you can select to view an item list or simulate how the instrument would be viewed by participants in data collection Page 36 SH Assessment Center View Options Preview item list Simulate instrument administration with customized settings Fl Show Execution Detail e g Item ID
122. on and creation of items within a custom instrument you have the option to export items into an external file This functionality is useful when wishing to distribute instrument item content to study collaborators who may not have access to Assessment Center To begin the export process click the Export button on the Instrument Detail page Once the button is clicked an automatic process will guide the user through how to save and or open the instrument export What are the guidelines for item ID naming for export in SAS Exporting is useful when wishing to distribute instrument item content to study collaborators who may not have access to Assessment Center When exporting transposed data in statistical analysis software package SAS you should keep ID name rules consistent with variable naming rules for that package If you are going to be exporting items into SAS please be aware that there are some guidelines when it comes to the naming of item ID s If these guidelines are not followed you may have errors when you try and upload your data Below are some guidelines for exporting into SAS e With the exception of underscore SAS does not read non alpha numeric characters well All variables must start with a letter or an underscore no numbers e Although item names can be up to 32 characters it s best to limit your names to 8 characters Page 26 SH Assessment Center Exclude an Instrument or Item Why would I exclude an Ins
123. order navigate to the Instrument Customization page by clicking on the Customize hyperlink next to the instrument name on the Study Content page Select Random from the Administration Method drop list If you select an Administration Method of Random or Sequential you may group similar items e g shared response options within an instrument together for administration All items from an instrument will appear You may use the Item Block Number field to group similar items together For example all items with a not at all to very much response scale may be in item block 1 whereas all items with never to always response scale may be in item block 2 If you have selected the administration method of random you may use the checkboxes at the top of the page to indicate if randomization of blocks and or items within blocks is desired If you have selected sequential the blocks will be administered in sequential order based upon their block number and the items within each block will Page 28 SH Assessment Center be administered in the order they appear on the Instrument Customization page To modify the order in which items appear on the Instrument Customization page access the Instrument Detail page and use the Order field Assessment Center CPP instruments MAPA a a tac Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization Instrument Customization
124. pants Accessed Study Registered Started Completed Off Study Refusal 25 2 2 1 0 0 0 To create a new participant registration record click the Find Create Login button To view a list of participants in this study click the Participant List button below Enter participant login then click Find Create Login button Participant Em to view an existing participant registration Find create Login NIH Inclusion Enrollment Report Data Dictionary Report Enrollment Report Request and Download Data When your data is available an email notification will be sent to the email below Click buttons to request or download data Please make sure that you are able to accept emails from this site 1 hanrahan northwestern edu Participant Registration How can l access a participant s registration information There are two ways in which a user can access a specific participant s registration records The first is an open search field in which a user must input a participant s study login number and click the Find Create Login button This is particularly useful when a study participant has contacted the study team because of a lost or forgotten password The second way to access registration information is the Participant List button When a user clicks on this button a dialog box will appear which contains the last name first name login and password of each participant within a given study The user may click on a participant
125. ple Assessments cera isolated 45 Modify Assessment Schedule sssessessssressreserresressressrersressressressressressressressresrresreesrersrersreeseerereseresreeseeees 46 Assign Instruments to Study Arms and ASSESSMENIS cccccsseccsecccsececnceceneeceeceeeceeenseeeueeteueseeeeceeeneens 48 M Um O ce iana T E O E E AAA 49 Identifying Clinician Rated InStruMentS cccoooccnncnicccnnnacnnnnaconnnanonnnnnccnnnnacnnonanononarnnonnrrnnonanononarcnonnncnnonanoso 50 Avoiding Redundant UCTS acia 51 Ada COS SUE Oa par E E A E A E E EAEE E E E 52 FS ON soi 53 ASC AP o o e AAA 55 Assessment Center Study Specific Data Collection Website sion aaa 60 ACUISTA 61 PC CF e E E E 61 Parucinant Fe USE ee OND dr did 62 PETTUS PUL CII Data ns tte caer tene E E E E A 68 Assessment SC WOO UNS odaran E E NE EE NE 69 Parcial RENO Sanar 70 RESC PER DOS setenta 71 MOY DI id 73 DE A E E saeinnpnieis ses sseitenpnoncsenss wanes ateossipssueiacsnontarmiseiipnedapars 73 RESPONSE TRACI tata 74 Export Field Describa asas oicadis 75 PIVOT Data EXDO rustico Ri 75 Protected Health Information PHI iaa rar ii ii 77 FHS EE eo io E Eo A E EIA 77 PRO UFO TING TAT QUESOS saint oa 7 COpyrent Nl Terms Ol USO crios eii noticias 78 A e E o OPC III nen seevsusecsiesaueat tocesaceeaciescoeieesser 79 Page 3 SH Assessment Center What Is Assessment Center Assessment Center is a free online research management tool It enables researchers to crea
126. r E instruments E Coe io Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument gt gt Item Details ACUM_4914 Item Detail new copr Statistics Save Cancel my ACUM_4914 Version Text Domain Communication g Emotion Type Multiple Choice Y Add another row Emotional Distress Negative Affect Anger Anxiety Fear E Pa ore Response Text Show Response Score Depression Sadness Not at all laa Delete End of Life Concerns Item Contains Protected A Little bit J Delete Fatigue f L le Delete Matar E Health Information PHI Responses Somewhat Delete Quite a bit an Delete Context In the past 7 days Very much Delete Stem I felt tired Administration AC User Original AC User Manual Example Creation 4 9 2014 Study Manual_Example Instrument Instrument Date What is the difference between an item context and item stem Assessment Center defines an item as the combination of an item context stem and responses The context field is intended for text that will frame the item such as timeframes During the past week or conditional statements Because of my illness The item context field is optional The stem field is intended for the text of the actual item or question and is required During data collection the item context appears on the f
127. reported outcome instruments to Instrument Block 2 The order of instruments within a given block can be fixed or random Under Block Administration select Fixed if you want blocks presented sequentially Select Random if blocks should be presented randomly You can have some blocks presented randomly and some fixed The Order Within Block field can be used to fix the instrument order or assign random order within an Instrument Block In the example below Block 1 is fixed while Blocks 2 and 3 are set to be administered in a random order The order of instruments within a given block see Order within Block column is sometimes fixed and sometimes random Here Instrument Block 1 is always administered first with the demographics instrument followed by clinical instrument Blocks 2 and 3 are always presented next but the system will randomly determine if Block 2 or Block 3 will be presented first The PROMIS instruments within Blocks 2 and 3 are also presented in a randomized order If you add an instrument to your study after you have initially set the instrument administration on the Arm Assessment Details page the newly included instrument will be placed in the last Order within Block position under the first block block 1 This will be done for all arm assessments You will need to access each Arm Assessment Details instance to make necessary revisions Page 49 SH Assessment Center Assessment Center So P E E REY A PDF Admi M
128. review scores from a CAT instrument as well as from a fixed short form of items from the same item bank If one were to add the CAT and short form to a single study it would be possible for the same item to be administered in each instrument To avoid presentation of duplicate items navigate to the Advanced sub menu tab within Set up Click on the Specify Instruments hyperlink for the appropriate arm assessment The CAT instrument will need to be administered first Select No Duplicates from the Administer drop list for the appropriate short form This instructs the administration engine to administer all the CAT items as defined by the parameters but not administer any items within the short form that have been administered in the CAT In order for the No Duplicates Engine to be applied the applicable CAT s and short form s must have the same Block value An Administer selection is not available if an instrument is using a non sequential administration engine i e CAT branch random Note that in the exported data files the items which appear on both the CAT and short form will appear twice once with the CAT and once with the short form even though it was only administered once In the Mode column of the Assessment Data export a redundant item will be coded as Participant via Web if a respondent was administered the item or Algorithm System Generated if the participant was not administered the item Page 35 SH Assessment Center Assessme
129. rms viewed by participants A consent form appears after the Welcome home page A participant is not able to move forward unless the consent is endorsed However if a researcher registers a participant from the Administration tab that participant will NOT view a consent The system assumes a researcher procured consent before registering a participant in a study When researchers register participants consent status is required within a study participant s registration record Registration What is registration Registration in Assessment Center is used to collect participant demographic and contact information Registration screens as defined on the Registration tab within Setup are presented after consent forms and before instruments Assessment Center allows for participants to self register or for study staff to register participants Registration information is to be completed by whoever is completing the registration form i e participant or researcher This means that if a researcher registers a participant the participant will not view the registration screens Registration fields are used in tracking participant accrual Data from these fields is used to populate accrual reports Age ethnicity gender race must be collected in Registration to take full advantage of the reports i e Enrollment Report and NIH Inclusion Enrollment Report If you collect these in a study instrument you will have to MANUALLY construct an accrual report
130. rticipant Data Current Study AC User Manual_Example2 To register a new participant enter information below and click Register Participant Login 82623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants a default Y Schedule Default w View Schedule Details Date Approach 4 30 20 14 e Internet Login optional 82623 Create participant login Password usg Study code 6002 Baseline gt Consent Test Preview Non Enrollment Reason Off Study Link Participant Data How can l link multiple participants In some studies multiple participants need to be linked to one another so that their data can be analyzed together e g proxy studies This can be achieved in Assessment Center through a variety of strategies 1 When a participant is registered by a researcher the Study code field can be used to link participants by entering a researcher defined ID code For example you would create registration records for a parent and child and give them both the same Study code e g 1001 so that statisticians can use this field to associate the two sets of data Another way to link participant records when participants are registered by a researcher would be to use the Create Participant Login feature and as
131. ruments is available for review Assessment Center enables customization of items or instruments e g format randomization skip patterns real time scoring of CATs storage of protected health information in a separate secure database automated accrual reports real time data export graphing of individual CAT or Profile scores and ability to capture endorsement of online consent forms among many other features ANNOUNCEMENTS PROMIS and Assessment Center Workshop in Chicago February 17 2012 Learn more about PROMIS item response theory computerized adaptive testing and Assessment Center at a full day workshop in downtown Chicago on Friday February 17 2012 For more information click on the Workshop hyperlink to the left New Feature Setup and administer assessments in English and nish Assessment Center can now administer the same study in English and Spanish A researcher can create a study and allow a participant to choose to view instruments in English or Spanish The researcher is responsible for uploading Spanish versions of instruments Additional features consent registration will be enabled in Spanish in the next release Future development will enable data collection in other languages Password continue Register New User Forgot Password Demonstration CAT Try out a PROMIS Computerized Adaptive Test and get an instant score report CATs include Emotional Physical and Social Health Click here to begin
132. s been included Required Fields Only required for consented participants First Name Rachel Last Name Hanrahan 625 N Michigan Street city Chicago IL Zie 60611 EMail State Day Ph Cell Ph 555 555 6767 Call Time Evenings Comments The Custom Fields page contains the custom registration fields as defined on the Registration page of the Set up tab The custom label field s and participant s response s will be displayed If no custom fields were included this page will be blank Assessment Center Studies Instruments Set up feet Administration ee ee Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual Example2 ustom Fields y pul p To register a new participant enter information below and click Register Participant Login 82623 button Please navigate to Participant Details Contact Information and Custom Fields tabs prior to clicking Register Participant button to ensure all necessary registration data has been included Required Fields Only required for consented participants Enter your date of diagnosis 09 13 20 13 Enter the number of nights you have spent in the hospital in the past year which you had surgery Northwestern Memorial How can study staff register participants Assessment
133. s name and be directed to his her registration information If name was not collected during at registration the list will display the text zzz Missing Missing This text is also a hyperlink which may be used to access the participant s registration Page 62 SH Assessment Center Assessment Center SU CE T 1 a Administration HSS GLE ia e Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant Data Current Study AC User Manual_Example2 Study Overview Study AC User Manual_Example2 Goal Participants Accessed Study Registered Started Completed Off Study Refusal 25 2 2 1 0 0 0 To create a new participant registration record click the Find Create Login button To view a list of participants in this study click the Participant List button below Enter participant login then click Find Create Login button Participant List to view an existing participant registration Find create Login NIH Inclusion Enrollment Report Data Dictionary Report Enrollment Report Request and Download Data When your data is available an email notification will be sent to the email below Click buttons to request or download data Please make sure that you are able to accept emails from this site r hanrahanQnorthwestern edu o What participant registration information can be accessed by study staff To be able to access registration pages for a partic
134. s text is used to inform participants of content changes give more in depth item specific instructions or indicate assessment progress To create these screens select Informational from the Response Type drop list This will only display item context where applicable and item stem There will be no response choices Note that embedding an instruction or transition item within an instrument is useful when a fixed item order is used If randomizing the order of items within an instrument or utilizing CAT is planned create a custom instrument that only includes the transition or instruction item What is a collapsed response category and how should one be handled There are instances when an analyst will collapse two response categories together because of infrequent responses in one of those categories This means that the two responses are treated identically in an IRT model When response categories are collapsed you should change the response scores to reflect which categories are collapsed i e the collapsed categories should have the same response score Doing this results in the appropriate number of thresholds appearing on the Item Statistics page Page 21 SH Assessment Center Assessment Center A instruments EE E a ET ee Cogn Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument gt gt Item Details ACUM_4914 Item Detail New Copy
135. sign the linked participants similar logins For example in a parent proxy study you could assign a parent and child the same login number followed by differing letters e g 1001p and 1001c In this example it would be important for the research staff to record the meaning of each letter and communicate this with the analysis team Please note multiple participants may not have the exact same login within the same study 2 Ifa participant is registering themselves via the data collection website a custom registration field or an item could be used to link participants In this case the custom registration or item would need to ask a question in which the participant could easily answer but would also be unique enough so that multiple participants would not respond with the same response For example in a parent proxy study you could ask the parent to provide their child s name and or date of birth while asking the child to provide this same information Another way to link participant records when utilizing participant self registration is to have the participant and proxy complete the same assessment For example the proxy instruments could be the first set of instruments a transition screen i e item with Informational response type could be Page 68 SH Assessment Center included immediately prior to the participant items which informs the proxy they have completed their part of the assessment and the participant should
136. sment Center Assemble From the Assemble tab you will be able to review and launch your study for data collection How do I create my study s data collection site The first step in preparing your study for preview and or actual data collection is to navigate to the Build Study page From this page click the Build button in order for Assessment Center to assemble your study s data collection site What do the warning and error messages on the Build Study page mean There are warnings which may appear within the Build Study page providing a check on the instruments you have included in your study Warnings will not prevent a study from being launched Instead they are a final check for you to ensure you have no problematic instruments in your study The first warning is The following items contain missing mismatched calibrations Please set IRT Parameters This warning identifies if a scored instrument includes uncalibrated items If this occurs the uncalibrated items will not be administered to participants Second the instruments listed in the Items from Multiple Domains check indicate that a CAT has items from more than one domain CAT construction involves calibrating a unidimensional construct Consequently if you have created a CAT from multiple constructs it may be problematic Third the Instruments with Duplicate Items warning notes instruments that share items You may consider using the No Duplicates function
137. ss a complete list of CAT IRT parameter variables and their definitions within Assessment Center Help https www assessmentcenter net ac1 Help index html What CAT IRT parameters are used for a given instrument To view CAT IRT parameters click on the Set IRT Parameters button on the Instrument Customization page On the CAT Parameters page users determine the set of item parameters i e threshold and slope values and where applicable modify the default administration parameters i e item selection and stopping conditions which should be used to administer a scored instrument An instrument may have one set of administration parameters per language calibration sample combination Assessment Center TA instruments SRS Cotas Sa ET SE My Accon Hop coga Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Customization Instrument Customization Instrument PROMIS Bank v1 0 Fatigue Save Cancel Administration Method CAT Set IRT Parameters Instrument type is CAT Only customization available is template selection Randomize Item Blocks Randomize Items within Item Blocks Templates determine how an item will appear to study respondents on the data collection screens Change all item templates to Please select Branching If Then Go To Template FATIMP1 In the past 7 days To what degree did you have to push yourself to get things done Not at all Please S
138. ssment It is important to ensure the logins from the two studies are the same i e login from first study used when registering participant to second study so the databases may be linked together during analyses An advantage of this solution is that it reduces the amount of manipulation to the study schedule for each individual participant However it does require merging data from the two studies In both scenarios it may be useful for data cleaning and analyses purposes to record the event date in a custom instrument item e g Please enter date of surgery Assign Instruments to Study Arms and Assessments How do establish what instruments are administered within an arm and an assessment Assessment Center allows you to tailor each assessment within a study arm For example you may wish to administer a sociodemographic instrument only at the first assessment and a study evaluation instrument only at the final assessment On the Advanced Study Set up page first establish the arm assessment schedule for your study by Page 48 SH Assessment Center naming each arm and entering values in the Assessment Day Assessment Opens and Window fields Once you have saved your assessment schedule the Specify Instruments hyperlink will become active Click on this hyperlink for the arm assessment row of interest to access the Arm Assessment Details page The arm name and assessment number will be listed at the top of this page All instru
139. ssment Center online consent feature then users should copy and paste their institution specific IRB approved consent form s into the Consent 1 2 or 3 fields as applicable To do so expand the applicable section by clicking on the plus minus sign next to the consent title You will then be presented additional sections for each language you have determined to use in data collection Click the plus minus sign next to the language title to expand the section and view the text box in which you may cut paste a consent form The easiest way to add consent forms in your study is to create them in a word processing program such as Word and use the copy paste functions to add them into Assessment Center This will allow you to take full advantage of formatting options e g spell checking fonts Within each consent section there are three checkboxes The first allows you to denote the consent form may contain Protected Health Information PHI by checking the Consent contains Protected Health Information PHI box When a data field is marked as containing PHI all data collected in this field will be flagged in the database and will be reported as containing PHI in applicable data exports This feature is intended to aid in de identification efforts and protect participant privacy The next two checkboxes are used to indicate how a participant will provide consent endorsement The first is a checkbox and the second is an open text field Users can specify t
140. stom instrument All items are created within an instrument To create new items first click the Create Item button from the Instrument Detail page You will be navigated to a blank Item Detail page to enter item components Required components include item ID item domain and item stem Once an item has been created you can continue to enter new items from the Item Detail page by clicking on the New button or the Copy button Clicking the Copy will generate an Item Detail page containing all previous item components except for the Item ID field which will be blank When copying an item you must enter a new Item ID and may modify any other item components Once you are done entering new items it is helpful to navigate back to the Instrument Detail page and review all items in your custom instrument Only users with the proper permissions for the current study may add or modify items The roles with permission to perform this function are the Study Administrator and Instrument Item Administrator If you would like to make revisions or create new items but do not have the appropriate permissions please contact the study administrator The Item Detail page is editable when an item only appears on a single instrument with a status of Under Development An item is view only when it has been added to more than one instrument or it is on an instrument with a status of Public Administered or Locked Page 19 SH Assessment Center Assessment Cente
141. stration questions e g Age are also added to your study when you opt to use certain Toolbox instrument These fields can be reviewed from the Registration tab within Set up How can learn more about an item After reviewing instrument information it may be useful to review the items within an instrument To view the items within an instrument click on the plus sign next to the instrument name the screen will expand to display all items To hide the items click on the minus sign Assessment Center mem x prere ar eng PDFs Admin MyA t Hel Soria Instruments AT Ce TSE y ys E o i iogoal Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Add an Instrument Add an Instrument First select instrument or battery a fixed set of instruments Use search criteria to find and add instruments batteries to your study Instrument 2 Battery Study Domain All Public All Show Results Search Results Add to Study Administration Select Name Study Type Domain O Neuro QOL Bank v1 0 Ability to Part Neuro QOL Item Bank CAT Social Function Ability to Participate in Social Roles Activities Statistics in SRA Computerized Adaptive Testing O E Neuro ooL Bank v1 0 AC Executive Neuro QOL Item Bank CAT Applied Cognition Executive Function Statistics unction Computerized Adaptive Testing NOCOG16 How much DIFFICULTY do you currently have checking the None Statistics
142. strumentLibrary pdf Where are the publically available Pediatric Instruments located Pediatric instruments may be added to your study from the Add an Instrument page Steps required to add the pediatric instruments are the same as those required for all instruments please see Add an Instrument Battery section above All public pediatric instruments will appear on the default instrument list They can be identified by the inclusion of the term Ped in the instrument name e g PROMIS Ped Bank v1 0 Fatigue Are the current instruments all that will ever be available in Assessment Center Instruments will continue to be added to the public Assessment Center Library Users can also create their own instruments from existing items as well as create modify their own items Create an Instrument What is a custom Instrument Users can create their own instruments which are called custom instruments within Assessment Center For example a user could tailor an existing instrument to for his or her study or a user may want to enter an instrument that is not currently in the Assessment Center library A custom instrument can only be viewed by the study team it is not available to the general public Instruments can be created in English Soanish German or French Future development will enable data collection in other languages While PROMIS instruments cannot be translated in Assessment Center in the future translated PROMIS instruments will be
143. struments Delete How can I set follow up assessments to be timed from a particular event e g surgery Assessments may be associated with an event outside of Assessment Center For example a researcher may want to have a baseline assessment completed 7 14 days prior to surgery and follow up assessments completed 6 week and 12 weeks from surgery date not date of baseline In this case Assessment Center needs information on when surgery happened in order to correctly time the follow up assessments There are a couple of ways to complete this requirement First a researcher could set up a study with a flexible assessment schedule see description above Once a participant s surgery occurs research staff should modify that participant s schedule for Assessment 2 and 3 please see Modify Assessment Schedule section for details A second option to accommodate an event based study design is to create multiple Assessment Center studies The first study would include only Assessment 1 i e the baseline pre event assessment The second study would include all follow up assessments which occur after the event During data collection once a participant completed the first study research staff would use the participant s login and password to manually register that participant to the second study In the second study registration the Baseline field on the Registration Details page should be the start date of the first follow up asse
144. t be created in Assessment Center You can only import translations for items existing in the specified custom instrument You cannot create your own translation file soreadsheet first and then upload your items and translations Assessment Center Instruments PDFs Admin My Account Help Logout Studies Set up Assemble Administration Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument Instrument Detail Instrument AC User Manual Example Instrument Save Cancel Order items within the instrument by altering the Order column and clicking Save To exclude an item from this instrument click on the Include checkbox 5 Hide Excluded Items Create Item Find Items Upload Translation Analyze Preview Export Translation Select language you would like to add click Export and choose Save Spanish Your translations were successfully uploaded File Name Date of Upload spanishtrans xlsx Apr 9 2014 10 59AM instrument Detail ID Responses o ACUM 4914 In the past 7 days I felt tired Not at all Include Statistics 4 Administration Study AC User Manual_Example History Notes Am I able to modify my item translations You may modify item translations at any time prior to launching your study into data collection After the initial import of a translation file to Assessment Center the translation fi
145. t recent change at the top In the top left of the screen is the current version of the item Each row in the table contains the previous version of the item that was subjected to a specific activity such as expert or patient review and comments from the reviews To add a new row of activity select a change category enter comments and click on the Add a Comment button To simply add additional text to an existing comment click on the Append hyperlink below the comment you wish to update Page 25 SH Assessment Center Assessment Center TN instruments ee E TN ET ina Logoi Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument gt gt Item Details ACUM _ 4914 gt gt Item History Item History Cancel ID ACUM_4914 Responses Not at al v In the past 7 days Not at all I felt very tired Comments Responses a oe 7 days 1 Not at all 7 i 2 A little bit Cognitive Patient Review 04 09 2014 Changes made 3 Somewhat 4 Quite a bit 5 Very much Stem I felt very tired Context Responses 1 Not at all In the past 7 days gt A little bit 3 Somewhat are a 4 Quite a bit 5 Very much Item History Category Please select 4 9 2014 Add Comment Comments New Item 04 09 2014 Append Instrument Export How can l export a custom instrument At any time during the selecti
146. te study specific websites for capturing participant data securely Studies can include measures within the Assessment Center library as well as custom instruments created or entered by the researcher PROMIS instruments short forms CATs profiles are a central feature of the instrument library within Assessment Center Any PROMIS measure can be downloaded for administration on paper or be included in an online study Detailed statistical information and development history about PROMIS items and instruments is available for review Assessment Center enables customization of item or instruments e g format randomization skip patterns real time scoring of CATs storage of protected health information in a separate secure database automated accrual reports real time data export graphing of individual PROMIS CAT or Profile scores and ability to capture endorsement of online consent forms among many other features SPONSORS PROMIS Neuro QOL NIH TOOLBOX http www nihpromis or http www neurogol or http www nihtoolbox or Registration How do register Before you can work within the Assessment Center you must register This includes setting up a Login and password as well as providing other information regarding your institution how to contact you etc and agreeing to Assessment Center Terms and Conditions To register yourself as a new user click on the Register New User link on the Assessment Center homepage http assessmentce
147. ted items in the language you wish to use during data collection Currently English Spanish German and French are supported by Assessment Center Additional languages will be Page 22 SH Assessment Center supported in future releases To add item translations to Assessment Center you must first export a translation file for your custom instrument then enter item translations into the exported translation file soreadsheet and finally import the spreadsheet containing item translations back into Assessment Center It is best to complete this process once you have added and created all the items in your instrument However it can be done at any time prior to launch To begin the process click on the Upload Translation button on the Instrument Detail page select the language of the translations you will be adding from the Language drop list and click the Export button Assessment Center des instruments Setup Assemble Administration PDFs Admin MyAccount Help Logout Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument Instrument Detail Instrument AC User Manual Example Instrument Save Cancel Order items within the instrument by altering the Order column and clicking Save To exclude an item from this instrument click on the Include checkbox Hide Excluded Items a Gadel ee a Select language you would like to add c
148. terminate in locked PBX rooms and in the data center Physical access is limited to secure and authorized personnel e Establish Computer Systems Security Plans for sensitive systems Security plans are in place for secure systems that house sensitive participant and financial data Page 83 SH Assessment Center e Conduct formal risk analyses Risk analyses are performed periodically as part of a more comprehensive audit process of the Information Systems department e Establish employee security awareness and training programs Security awareness and training programs are in place They are included in employee orientation and are included in the Northwestern University s Emergency Response Procedures In addition Northwestern University s Department of Medical Social Sciences provides its own employees with security training with regards to data collection and storage e Maintain accurate inventory of all hardware and software Computer inventory and software are maintained in both hard copy paper soreadsheet and database programs Northwestern University s Department of Medical Social Sciences maintains an inventory management database detailing all hardware software and software licenses e Establish contingency plan Contingency plan for disaster recovery is in place e Establish emergency power program The Northwestern University Research Data Center has 2 Uninterruptible Power Supplies and a Diesel generator in th
149. ters participants a specific study arm may be selected at that time How can study staff record information about those who didn t enroll in the study Assessment Center allows for a researcher to track participants that were approached but not enrolled in a study First a researcher would click on the Find Create Login button on the Administration tab s Study Overview page and be navigated to a blank Registration Details page A researcher would select No in the Consent field and optionally select a response from the Non enrollment Reason drop list If a researcher has information on other registration variables such as age race or name this information can be entered on the other registration submenu tabs Non enrollment information is aggregated in the Enrollment Report Page 67 SH Assessment Center How can study staff take a participant off of a study From the Administration tab access the participant s record either through the Find Create Login or Participant List buttons On the Registration Details page select the appropriate Off Study reason from the drop list provided Do not modify the Consent field Click on the Register Participant button to save changes This information automatically updates the Accrual Dashboard and the accrual reports purga cs TA Setup pr Administration PDFs Admin MyAccount Help Logout Overview Registration Details Participant Details Contact Information Custom Fields Reports Pa
150. three response option types initially are assigned two response rows To add additional response rows click on the Add Another Row button within the response option box You may also delete response rows A checkbox item is limited to 63 response rows Page 20 SH Assessment Center A t Center IST instruments HEAT T EET a ee ee Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument gt gt Item Details ACUM_4914 Item Detail New Copy Statistics Save Cancel ID ACUM_4914 Version Text Domain Communication Emotion Type Multiple Choice Y Add another row Responses Emotional Distress Negative Affect Anger i F k ay sii Response Text Show Response Score Depression Sadness 1 Not at all Delete Item Contains Protected 7 A Little bit Delete Health Information PHI H Somewhat Delete Context r B In the past 7 days m Quite a bit Delete Very much _ Delete Stem I felt tired Administration AC User Original AC User Manual Example Creation Date Study Manual_Example Instrument Instrument 4 9 2014 How do create transition screens informational item without a response option You may choose not to display a response scale when instructions or transition screens are desired in an instrument Thi
151. ticipants Pa default Schedule Default v View Schedule Details Kaie Appana 4 30 2014 Eae Internet Y Login optional Password usg Study code Baseline Consent O y Preview Non Enrollment Reason Off Study Language En gli sh What triggers Assessment Center to know when to open the first assessment for a given participant A schedule is determined by the date in the Baseline field on Registration Details If a researcher completes the Baseline field when registering a participant the study schedule will be established and the baseline assessment window will open Ifthe baseline field is left blank the study schedule will not be established until the participant logs into the data collection website This is useful if a researcher is not requiring a participant complete the baseline assessment on a specific date but at the participant s convenience in the future If a participant self registers the baseline date is stored as the date the login and password are assigned How can a researcher assign a participant to a specific study arm If a study has more than one arm how a participant registers is important If participant self registration is utilized Assessment Center will assign each participant to a study arm A researcher can look up what study arm was assigned through the Administration tab If the researcher regis
152. trument or Item Assessment Center does not actually delete objects Rather to protect the integrity of the instruments and items that are available to all users features such as Include Exclude and Hide to help you manage the appearance of your study You can choose to exclude an instrument from a study or items from an instrument This functionality is similar to the Archive Study feature previously seen on the Studies page A checkmark in the Include box indicates that an instrument is included in a study Unchecking the box will exclude an instrument When the inclusion status of an instrument is changed you must provide a reason for inclusion exclusion in Notes which will automatically pop up in a second window when inclusion status is changed It may be helpful to record the date of the status change to help track a study s history Excluded instruments will automatically be moved to the bottom of the instrument list Re include an instrument check the Include box Assessment Center MPA instruments MRSS Coren aa Unrate en ee ee Hep Togos Current Study AC User Manual_Example Study Content AC User Manual Example gt gt Instrument Detail AC User Manual Example Instrument Instrument Detail Instrument AC User Manual Example Instrument Save Cancel Order items within the instrument by altering the Order column and clicking Save To exclude an item from this instrument click on the Include checkbox 5 Hide Excluded Items
153. truments to their study from the Instrument Library and initiate the creation of new instruments Add an Instrument Battery How do I add an existing instrument to my study Access the instrument library by clicking the Add button on the Study Content page You will be navigated to the Add an Instrument page The page defaults to display all instruments designated as public in the Assessment Center library You may review and select instruments from this list or you may use the search criteria to target results Assessment Center houses instruments e g a depression short form and batteries collection of instruments NIH Toolbox has batteries for Emotion Motor Cognition and Sensation On the Add an Instrument page you will first need to decide if you want to search for instruments default or batteries At the top of the page are three drop lists that enable you to customize a search Make a selection and click on the Show Results button to view your search results Instruments with a status of Administered or Public are eligible for inclusion Instruments with a status of Under Development or Locked will not appear in the search results If you would like to use NIH Toolbox batteries or instruments in a study you must request access via nihtoolbox org Page 12 Assessment Center Assessment Center A instruments ONS hy Conn Sa Ye nett een di ro ee eee Current Study AC User Manual_Example Study Content AC User Manual Example gt
154. ublicly available instrument to one of your custom instruments you are able to upload a translation for that item The translation of your custom instrument and its items will be available to anyone who uses that instrument Currently study team members may use your custom instrument in other studies The translations of the item will not be available if the item is added to another custom instrument e each custom instrument must upload individual translations within Assessment Center Item History Can review item development In an effort to retain and report steps within item and or instrument development Assessment Center includes an item history feature When an existing item is modified in any way e g addition of response option or grammatical change to stem an item history entry is required The Item History page is accessed by the History hyperlink next to the item on the Study Content and Instrument Detail pages or by clicking the Show Item History button from the Item Detail page A change category and reason for change is required each time an item is modified This information is stored in the Item History page so that changes may be reviewed You may also add comments if you have the appropriate permission on the study in which the instrument was created Item History change categories include Expert Editorial Review Cognitive Patient Review and Translatability Review Entries are listed in chronological order with the mos
155. ular study staff must have the Study Administrator Study Participant Administrator or Study Data Entry Administrator roles After conducting a participant search the first registration page to be accessed is the Registration Details page Once this page has been accessed users may also navigate to the subsequent registration pages i e Participant Details Contact Information Custom Fields Reports and Participant Data by using the sub menu tabs The Registration Details page contains study specific information such as consent status password date of first assessment and administration language Some of the information on the Registration Details pages is default information that is automatically populated when a participant registers to the study If you are completing an assessment yourself for quality assurance purposes you would select Test from the Consent Obtained field This will segregate test data from true participant data in the database and data exports If a participant must withdraw from a study for any reason the reason for withdrawal can be recorded on this page using the Off study drop list Ifa participant refused to participant in the study and you would like to record the reason use the Non Enrollment Reason drop list Page 63 SH Assessment Center Assessment Center SO E 11 Administration A e BOLD Overview Registration Details Participant Details Contact Information Custom Fields Reports Participant
156. users to your study click on that person s name then click the right arrow button The user will be moved from the All Users box to the Team Members for Current Study box Page 10 Assessment Center Assessment Center Studies pana Setup apparsa ra PDFs Admin MyAccount Help Logout Current Study AC User Manual_Example Study List AC User Manual_Example Study List To get started please select an existing study or create a new one Then continue work in the system by selecting from the tabs above Create New Study To select click on study name J Hide Archived Studies My Studies Name Created By AC User Manual Example Hanrahan Rachel 4 7 2014 Properties 6723 Sat with Social Roles Profile 29 Properties 6916 ProxyDepSansLocal Hanrahan Rachel 7 19 2013 Properties 6916 Score Ver AnxPeds DepPeds Proxy Hanrahan Rachel 7 19 2013 Properties Who can see my work on this study in particular participants data Team members will be able to view information in your study based on their roles Assessment Center users that are not part of the study team will not have access to any study information or participant data You may want to click on the Team feature to ensure the team role assignments are appropriate New team members are automatically assigned the role of Associate this role has read only access to study elements To reassign roles select a team member s name and then check the Role box s that
157. utton LAUNCH STUDY f a L h WARNING Study items and instruments may not be revised after Launch be Page 58 Assessment Center Launch How do create a website to collect participant data The Launch function allows you to create a data collection website After you have reviewed your study configuration export previewed your data collection site and endorsed applicable Terms amp Conditions you may click the Launch button to create the data collection website The amount of time it takes for Assessment Center to complete the launch process is dependent upon the size of your study e number of instruments or assessments and how many other studies are concurrently being launched Once the launch is initiated a progress screen will appear detailing the percentage of study content to have completed the launch process Once the launch process is complete a hyperlink to the data collection website will appear at the top of the Launch Study page Your study is being launched If you have any problems during this time please email help assessmentcenter net 50 What information can be modified after a study has been launched Assessment Center allows users to update some Set up fields after a study has been launched for data collection These fields include the study end date accrual goal contact information login screen welcome text date assessments open assessment window text of consent documents e
158. xclude a particular instrument from an individual assessment on the Arm Assessment Details page For more details on Toolbox instrument ordering please click on the hyperlink below http www nihtoolbox org HowDol HowToAdministerTheToolbox Documents NIH 20Toolbox 20Measure s 20order_Adminstration 20Manual 2011 29 20EB pdf There are times where you do not want to exclude an instrument from the whole study but just a particular assessment This is accomplished on the Advanced Study Set up page within the Set up tab Click on the Instrument Block drop list and select Not Included For more information please see the Assign Instruments to Study Arms and Assessments section of this manual Page 27 SH Assessment Center Establish Instrument Order How do I define the order of instrument administration for my study Instrument order is defined in multiple places in Assessment Center Fixed ordering of instruments as well as more complex presentation schemes are allowed If you want to administer instruments in a fixed order you can order them on the Study Content page by typing in the correct order number in the Order field For more complex Instrument ordering you may group instruments on the Arm Assessment Details page More information on how to group instruments is available in the Set up section of this manual Assessment Center E instruments ET Se e a ae Current Study AC User Manual_Example Study Content AC User
159. y U German Z French Y English O Spanish Currently instruments may be administered in English Spanish German or French Upon instrument creation one language was set as the default on the Instrument Properties page If you have uploaded additional language translations or another translation exists those languages will appear as an additional selection on the Language page You will have option to select one or more languages for administration If you select more than one language a screen will appear at the beginning of data collection prompting participants to select their preferred language The selection is recorded on a participant s Registration Detail page and is available in the data exports Select your desired language English Seleccionar el idioma deseado Espa ol Wahlen Sie die gew nschte Sprache Deutsch Veuillez s lectionner une langue Francais Page 41 SH Assessment Center Will all data collection screens be available in my selected language Currently English Spanish German and French are supported in Assessment Center Participants will see all system text default welcome text non custom registration screens login password assignment error messages etc in their selected language If you are collecting data in a non English language be sure to review how to upload consent forms and registration fields in the desired language These instructions are included later in this manual Wh
160. y A Hel t Studies instruments Set up Assemble Administration gt sare si sewers Language Basic Advanced Consent Registration Current Study AC User Manual_Example Advanced Study Setup AC User Manual Example gt gt Specify Instruments Arm Assessment Details Arm armi Assessment 1 Save Back Instruments can be blocked These blocks can be administered randomly or in a fixed order Instruments in the same block are administered together in a random or pre defined order Instrument Block Block Administration Instrument Order within Block Completed by Participant Administer PROMIS Sociodemographic Example All Items PROMIS Clinical Form Example Y All Items PROMIS Bank v1 0 Depression CAT PROMIS Bank v1 0 Anxiety Y CAT PROMIS Bank v1 0 Pain Behavior CAT PROMIS Bank v1 0 Fatigue CAT Identifying Clinician Rated Instruments How can include instruments in my study that are completed by research or clinical staff Sometimes researchers want to include instruments that are tied to a given research participant but are completed by research or clinical staff e g a physician s rating of performance status for a research participant or research assistant completed medical history review Assessment Center allows for some instruments to only be accessed by research staff through the Participant Data page on
161. y that the entire data set is selected selected cells will have a flashing dotted line around the perimeter Next drag PIN to the white field Choose the data that you want to analyze Select a table or range Table Range REA Use an external data source Connection name Choose where you want the PivotTable report to be placed 3 New Worksheet Existing Worksheet Location opmarcs Settings under the heading Row Labels see Figure 2 Drag ItemID to the field under Column Labels Drag Score to the Values Field and DataType to Report Filter Click on the triangle in the yellow field under values Click on Value Field Settings in the drop down menu that appears In the Value Field Settings dialog box select Average on the Summarize by tab and click OK see Figure 3 Click on the upper right hand x to close the PivotTable Field List dialog box On the pivot table click on the triangle button next to DataType all In the box that appears PreotTable Field List Choose fields to add to report Plstcode E Assmnt F mdlOrdr Pl InstOrdr FJ instsctn F ItmOrdr A Inst locale F Mode ItemID Score Drag fields between areas below F Report Filter Column Labels Datalype 7 temo check the box next to Select Multiple Items Click the OK button To complete the process click on the Insert a E aaa l Worksheet ico

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