Lumbar Puncture Data Management System User`s Manual
Contents
1. University e University of California Irvine e Columbia University e University of California Los Angeles e Duke University Medical Center e University of California San Diego e Emory University School of Medicine e University of California San Francisco e Florida Alzheimers Center e University of Kentucky e Indiana University e University of Michigan e Johns Hopkins University e University of Pennsylvania e Massachusetts ADRC e University of Pittsburgh e Mayo Clinic e University of Southern California e Mount Sinai School of Medicine e University of Texas Southwestern e New York University e University of Washington e Northwestern University e Washington University e Oregon Health amp Science University e Wisconsin e Rush University Medical Center After you click your Center name you will be taken to the following page for your Center NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center CONSULTATJ 2 INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIA NACC LP Survey for Sample When you click this link you will be directed to the following page where you will need to enter a personal identifier Choose a simple identifier one you can remember easily in case you need to go back and modify or complete the form NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coor2. data from subjects and medical records and complete the surveys This particular study is sponsored by the Alzheimer s Association and will ultimately be analyzed along with data from the Global Biomarker Consortium survey conducted outside the U S Blennow et al Please note that on each of the questionnaires in the study responses may be saved and work resumed later in case of interruption For a brief description of the study components click here Lumbar Puncture Data Management System User s Manual Lumbar Puncture Data Collection System e The ADC LP Experience Questionnaire The LP Requestor Questionnaire e The Patient LP Experience Safety Study Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 5 THE LP REQUESTOR QUESTIONNAIRE Clicking the link to The LP requestor questionnaire will bring you to the following page Click your Center s name You can access only the Center for which you are authorized NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS _ FANIILIES The LP Requestor Questionnaire Note If you are using Firefox 4 please click here if you are having trouble with webpages being cut off e Sample e University of Alabama Birmingham e Arizona Alzheimers Center e University of California Davis e Boston
3. s Manual Version 1 00 September 2011 Page 2 Please note The patient LP experience study is to involve only those UDS subjects for whom LP is planned or requested as part of the ADC diagnostic workup or other research protocol thus no patients should be recruited to have an LP simply to provide data for this study Also because study data should be collected only from UDS subjects the survey should not require any ad ditional human studies consent beyond that normally included in ADC enrollment however It is always best to confer with your Institution s IRB Of course the consent for the LP procedure Itself IS a Separate issue Detailed operation of the lumbar puncture data management system ACCESSING THE SYSTEM The system is accessed through the NACC website Before using this system you must contact NACC at naccmail uw edu to let us know you need access to the LP Data Management System In your email please tell us e Your name e The name of your Center e Your ADC role e g Director Administrator Clinical Core Leader e What function you will perform in the study person designated by Director to submit ADC LP Experience form LP requestor or designated patient coordinator If NACC determines that you are authorized to access this area of the website e f you already have a NACC account we will modify the permissions on that account to give you access to the LP Data Management System e f you do not already h
4. Center 4 Name and role of person completing this form First name Last name Your position Center LP activity 4 Are LPs performed as part of Center related activities No Ifyour Center does not perform LPs or if it performs LPs on less that 10 of subjects what would be needed to increase the number of LPs performed at your Center CHECK ALL THAT APPLY If you answered no to Question 4 above then answer Question 5 and end questionnaire here Who usually asks the subject to have an LP CHECK ONLY ONE Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 AD biomarker assays with better diagnostic accuracy Lower cost for assays and or LP procedure More time for doing LPs better reimbursement Better drugs that would improve the value of a more accurate diagnosis Other SPECIFY NIA Other SPECIFY Page 4 Once you have submitted the form automated error checking will begin to ensure that all items have been completed If the form is not complete you will get an error message like the one below At this point you should supply the missing response s and resubmit the form NACC National Alzheimer s Coordinating Center NACC ADC LP Experience Questionnaire Sample Center _ l ADC LP Experience Form has questions unanswered Questions not answered Question 8 has not
5. ERVIEWERS CLINICIANS FAMILIES CAREGIVERS Lumbar Puncture Data Collection Three separate and distinct surveys are included in the LP study database The ADC LP experience The LP requestor e The patient LP experience o Initial questionnaire o Follow up questionnaire The first two surveys are brief and easy to complete and will involve only a few people per ADC The patient LP experience will report on all subjects asked to undergo an LP during about two years of study a designated patient coordinator will be required who will obtain the necessary data from subjects and medical records and complete the surveys This particular study is sponsored by the Alzheimer s Association and will ultimately be analyzed along with data from the Global Biomarker Consortium survey conducted outside the U S Blennow et al Please note that on each of the questionnaires in the study responses may be saved and work resumed later in case of interruption For a brief description of the study components click here Lumbar Puncture Data Management System User s Manual Lumbar Puncture Data Collection System e The ADC LP Experience Questionnaire The LP Requestor Questionnaire e The Patient LP Experience Safety Study Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 7 THE PATIENT LP EXPERIENCE SAFETY STUDY Clicking the link to The patient LP experience Safety Study will bring you to
6. Lumbar Puncture Data Management System USER S MANUAL Version 1 00 September 2011 National Alzheimer s Coordinating Center www alz washington edu The Lumbar Puncture Data Management system Introduction The Lumbar Puncture LP Data Management System was designed by the National Alzheimer s Coordinating Center to permit web data entry for each of the three LP Study components The ADC LP experience questionnaire The LP requestor questionnaire and The Patient LP experience which comprises two forms an initial and a follow up questionnaire Each Center s data are secured and available only to authorized personnel at that Center Reports may be generated by each Center and across Centers by the project PI and staff Requirements The following are recommended for use of the LP Data Management System e Hard wired Internet connection A modem may be used but can be slow and tedious e Minimum browser Microsoft Explorer 8 0 or Firefox 4 0 Other browsers and versions will work but the displays may be difficult to use e Minimum screen size 17 inches Smaller sizes will work but will be more difficult to use Contacts For any type of assistance with the website or data entry please use the contact information below Email naccmail u washington edu Phone 206 543 8637 For clinical questions related to the survey contact John Morris MD at morrisj abraxas wustl edu Security Only personnel authorized
7. NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center ONSULTA INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATACORES DATAMANAGERS INTERVIEWERS CLINICIANS NACC The Patient LP Experience Safety Study for Sample The Patient LP Experience To enter data for The patient LP experience initial questionnaire click the appropriate link and the following page will be displayed NACC he NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION NACC The Patient LP Experience Initial Questionnaire Sample Center Enter a personal identifer Initials etc Select an PTID to Fill out an LP Survey for New LP 000018 LP entered for 5 7 2012 Patient ID 000018 Add New LP Patient ID 003wd LP entered for 8 18 2011 Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 8 Enter a personal identifier one you can remember easily in case you need to go back and modify or complete the form You also must use the same identifier when you complete The patient expe rience follow up form during the following week Choose the NACC ID of the patient whose form you are entering and click Continue to go to the electronic form where you can enter data and save it to resume later or submit it when completed NACC atonal Alzheimers Coordinating Conter QUESTIONNAIRE
8. The patient LP experience initial Adapted from the Alzheimer s Association Multi center Study on Lumbar Puncture Kaj Blennow et al and the Alzheimer s Association used by permission INSTRUCTIONS Please complete this form for each ADC patient subject who is asked to undergo an LP This form is to be completed by the designated patient coordinator at the time a patient is first asked to have an LP Information should be based on medical records patient or co participant report and clinician observation and or judgment 1 Today s date X 2011 2 ADC name Sample Center 3 Patient ID use UDS ADC ID 0 4 Person performing the LP Neurologist Geriatrician Psychiatrist internist Resident INDICATE SPECIALTY e g neurology psychiatry Medical student Other SPECIFY 5 How experienced is this person in performing LPs Limited experience has performed lt 10 LPs Experienced has performed 10 100 LPs Very experienced has performed gt 100 LPs ry Reason for performing the LP HECK PRIMAR A ininal ranaarah antich Patient demographics and medical history Once you have submitted the form automated error checking will begin to ensure that all items have been completed If any errors are found modify the form and resubmit To enter the follow up data which are collected one week after the LP is performed go to the follow up form under The patient LP experien
9. ave a NACC account we will ask you to choose a user name and pass word so that we can create one for you You may then access the system by going to the entrance portal at https www alz washington edu LP Ipdata html NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center SULTATIO INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS FAMILIES CAREGIVERS Lumbar Puncture Data Collection Three separate and distinct surveys are included in the LP study database The ADC LP experience e The LP requestor e The patient LP experience o Initial questionnaire o Follow up questionnaire The first two surveys are brief and easy to complete and will involve only a few people per ADC The patient LP experience will report on all subjects asked to undergo an LP during about two years of study a designated patient coordinator will be required who will obtain the necessary data from subjects and medical records and complete the surveys This particular study is sponsored by the Alzheimer s Association and will ultimately be analyzed along with data from the Global Biomarker Consortium survey conducted outside the U S Blennow et al Please note that on each of the questionnaires in the study responses may be saved and work resumed later in case of interruption For a brief description of the study components click here Lumbar Puncture Data Manageme
10. been filled in Question 9 has not been filled in Question 10 has not been filled in Question 11 has not been filled in Question 15 has not been filled in Question 17 has not been filled in Edit and re submit below Once the form is submitted and complete the following page will be displayed NACC NIA Alzheimer s Disease Centers Program National Alzheimers Coordinating Center CONSULTATI O INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MAN AGERS INTERVEWERS CLINICIANS FAMILIES CAREGIVERS NACC ADC LP Experience Questionnaire Sample Center ADC LP Experience Form has been Updated To enter data for the next form go back to the Lumbar Puncture Data Collection entrance portal NACC NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS FAMILIES CAREGIVERS Lumbar Puncture Data Collection Three separate and distinct surveys are included in the LP study database The ADC LP experience The LP requestor The patient LP experience o Initial questionnaire o Follow up questionnaire The first two surveys are brief and easy to complete and will involve only a few people per ADC The patient LP experience will report on all subjects asked to undergo an LP during about two years of study a designated patient coordinator will be required who will obtain the necessary
11. by the Centers have access to the system Users who already have a NACC account must email NACC to let us know they would like to access the LP survey so that we can build the proper permissions into their accounts Users who do not yet have a NACC account must request one For more details on setting up or modifying NACC accounts see Accessing the system on page 3 of this manual Users have access only to their own Center s data All data transmitted across the Internet are encrypted with at least a 128 bit encryption suite The forms in the survey and who should fill them out Three separate and distinct surveys are included in the LP study database The ADC LP experi ence The LP requestor and The patient LP experience which is further divided into an Initial and a follow up questionnaire the latter to be completed one week after the patient undergoes an LP The first two surveys are brief and easy to complete and will involve only a few persons per ADC The patient LP experience initial questionnaire will report on all subjects asked to undergo an LP during about two years of study while The patient LP experience follow up questionnaire will be submitted only for those subjects who actually undergo an LP A designated patient coordinator will be required who will obtain the necessary data from subjects and medical records and complete the surveys The patient LP experience part of the study is sponsored by the Alzheimer s Ass
12. ce Safety Study tab NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center CONSULTATIO INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS NACC The Patient LP Experience Safety Study for Sample The Patient LP Experience Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 9 To enter data for The patient LP experience Follow up form click the appropriate link and the following page will be displayed NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS FAMILIE NACC The Patient LP Experience Follow up Questionnaire Sample Center Enter a personal identifer Initials etc_ Select an PTID to Fill out an LP Followup Survey for Patient ID 0 LP entered on initial date Enter the same personal identifier that you used when entering the initial patient experience form Choose the NACC ID of the patient whose form you are submitting and click Continue to go to the electronic form where you can enter data and save it to resume later or submit it when it Is completed QUESTIONNAIRE NACC The patient LP experience follow u Adapted from the Alzheimer s Association Multi center Study on Lumbar Puncture Kaj Blennow et al and th
13. d abstract LP procedure data from the medical record to complete the web based questionnaire How many should be One for each time a UDS patient is asked to undergo an LP thus if over time a submitted given patient undergoes more than one LP or additional LPs are requested a form should be completed and submitted for each LP request This study will continue for approximately two years and must include all such patients subjects When Form should be completed just after the patient subject is asked to undergo an LP for the entire two years of the study Both subjects who decline LP and those who agree should be included e The patient experience follow up questionnaire To be completed ONE WEEK after initial questionnaire Number of questions 23 Who should complete The same designated patient coordinator who interviewed the patient subject or co participant a week earlier to complete the Initial survey will perform follow up interviews in person or by telephone How many should be One for each UDS patient who underwent an LP the previous week and was re submitted ported on in The patient LP experience questionnaire ADC UDS patient ID must match Subjects who decline LP will not have a follow up survey When Web based form should be completed approximately ONE WEEK following the LP for each patient during the entire two years of the study Lumbar Puncture Data Management System User
14. dinating Center CONSULTATION INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS Researchers Website NACC LP Requestor Form Identifier Selection Sample Center Enter a personal identifer Initials etc Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 6 After you enter your personal identifier click Continue to go to the electronic form where you can enter data You can enter data and save it to resume later or submit it when completed QUESTIONNAIRE The LP requestor This form shouid bs completed by esoh ADC member who sotusily asks an ADC patient subjeot to undergo 1 Today s cse ADS name Sample Cemer Position of person completing this form LP requestor raphios 4 Are you he person who ususilly asks a patie to have an LP 5 Plesse provide the toliowing information L Amarican indian of Alaska Native U Native Hawaiian o other Pscific islander asian Once you have submitted the form automated error checking will begin to ensure that all items have been completed If any errors are found modify the form and resubmit It To enter data for the next form go back to the Lumbar Puncture Data Collection entrance portal NACC The N sease Centers Progra National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INT
15. e Alzheimer s Association used by permission INSTRUCTIONS Please complete this follow up form for each ADC patient subject who was reported on the initial Patient LP experience form and who actually underwent an LP This form is to be completed by the designated patient coordinator based on records observation and or patient report approximately one week after the patient s LP is done Approximate time of day LP was performed HH MM Was the LP performed with the patient in a fasted state Was the patient given any medication not including local anesthesia E W Yes a premedication e g diazepam for anxiety yes other SPECIFY Position of patient during LP Lying down supine position Sitting Type of needle used for LP Quincke or similar needle with cutting edge Sprotte or similar pen point needle Other SPECIFY 21G 0 8 mm 226 0 7 mm 236 0 6 mm 24G 0 5 mm Once you have submitted the form automated error checking will begin to ensure that all items have been completed If any errors are found modify the form and resubmit It Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 10
16. nt System User s Manual Lumbar Puncture Data Collection System e The ADC LP Experience Questionnaire Entrance portal to the e The LP Requestor Questionnaire Lumbar Puncture e The Patient LP Experience Safety Study niu Data Management System Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 3 THE ADC LP EXPERIENCE QUESTIONNAIRE Clicking the link to The ADC LP experience questionnaire will bring you to the following page Click your Center s name You can access only the Center for which you are authorized NACC e NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center ONSULTATION INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS FAMILIES CAREGIVER ADC LP Experience Questionnaire Note If you are using Firefox 4 please click here if you are having trouble with webpages being cut off e Sample e University of Alabama Birmingham e Arizona Alzheimers Center e Boston University e University of California Davis e University of California Irvine e Columbia University e Duke University Medical Center e University of California Los Angeles e University of California San Diego e Emory University School of Medicine University of California San Francisco e Florida Alzheimers Center e Indiana University e Johns Hopkins University e Massachusett
17. ociation and will ultimately be analyzed along with data from the Global Biomarker Consortium survey conducted outside the U S Blennow et al Lumbar Puncture Data Management System User s Manual Version 1 00 September 2011 Page 1 Please note that on each of the questionnaires in the study responses may be saved and work resumed later in case of interruption Following is a brief description of the study components THE ADC LP EXPERIENCE Number of questions 17 Who should complete One Director designated person per ADC limited to the Director Administrator or Clinical Core Leader When Initially and after one year How many should be submitted One form per Center only THE LP REQUESTOR Number of questions 20 Who should complete Any and all ADC personnel who ask subjects or patients to have an LP and are responsible for explaining the LP procedure to them When Initially in the event of a new requestor and after one year for each person completing initial survey How many should be submitted One for each ADC LP requestor as described above THE PATIENT LP EXPERIENCE SAFETY STUDY e The patient experience initial questionnaire Number of questions 17 Who should complete One designated patient coordinator e g nurse social worker or other health professional per site who will interview the patient subject or co participant in person or by telephone an
18. s ADRC e University of Kentucky e University of Michigan e University of Pennsylvania e University of Pittsburgh e Mayo Clinic e University of Southern California e Mount Sinai School of Medicine e University of Texas Southwestern e New York University e University of Washington e Northwestern University e Washington University e Oregon Health amp Science University e Wisconsin e Rush University Medical Center After you click on your Center name you will be taken to the following page for your Center NACC The NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center ONSULTATIO INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS Researcher s Website NACC LP Survey for Sample ADC LP Experience Questionnaire When you click this link you will be taken to the electronic form where you can enter data and save it to be completed later or submit it when it is complete NACC National Alzheimer s Coordinating Center QUESTIONNAIRE The ADC LP experience INSTRUCTIONS The information reported on this survey must be certified by the ADC Director This form should be completed by the ADC Director Administrator or Core Leader who can authoritatively report ADC experience and or policy concerning LP procedures Only one form per center should be submitted Today s date bd i 2011 _ ADC name Sample
19. the following page Click your Center s name You can access only the Center for which you are authorized NACC NIA Alzheimer s Disease Centers Program National Alzheimer s Coordinating Center INVESTIGATORS RESEARCHERS ADC ADMINISTRATION DATA CORES DATA MANAGERS INTERVIEWERS CLINICIANS FAMILIES CAREGIVERS The Patient LP Experience Safety Study Note If you are using Firefox 4 please click here if you are having trouble with webpages being cut off e Sample e University of Alabama Birmingham e Arizona Alzheimers Center e University of California Davis e Boston University e University of California Inine e Columbia University e University of California Los Angeles e Duke University Medical Center e University of California San Diego e Emory University School of Medicine University of California San Francisco e Florida Alzheimers Center University of Kentucky e Indiana University e University of Michigan e Johns Hopkins University e University of Pennsylvania e Massachusetts ADRC e University of Pittsburgh e Mayo Clinic e University of Southern California e Mount Sinai School of Medicine e University of Texas Southwestern e New York University e University of Washington e Northwestern University e Washington University e Oregon Health amp Science University Wisconsin e Rush University Medical Center After you click your Center name you will be taken to the following page for your Center NACC he
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Lumbar Puncture Data Management System User`s Manual