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Bone Density (DXA) (Version 1.0p, May 2009)

1. aee eaae seen setate seta aee eaaa 24 5 Data PEE 25 5 1 Hard of iI 25 5 2 Electronic scan archive ri eno te veo een Kov ee na So nh ans 25 5 3 Transfer of data to the MOST DXA Quality Assurance Center 26 5 4 Return materials sent by the MOST DXA Quality Assurance Center 30 Appendix Hologic Whole Body Phantom Protocol eee ee eee e ee ee eere een eee seen aeta aen 31 Appendix B St dy FOEFWIS erecto eene rh ore eee eo einen eo eet on apre votes eos teen eoe e duo repe eo Pea eaa reo oc Ou 35 MOST M OVI Soh 36 MOST DXA HOLOGIC BIOGRAPHY INFORMATION eeeee eee eee een eee tn tnos esee ense ette ener seen 39 MOST DXA Participant Scan Log eese cente ee eee eee enne seen eet sese eaae sten asse ease eese etas e essa aee 40 DXA Batch Record FOrm cccz icicccsccsaseveciesssesctivossscstssscesesenvees 41 DXA Repair Service 42 Whole Air QC Scan Worksheet cssssssscssssccsssssssssssssscsssccsssssssssesssssccsssssssssssssssscssccssesssssssscossees 43 Excessive bone loss alert E 45 Whol
2. O Severe degenerative disease Other Please specify Yes Last 2 characters of scan ID Date of scan Which hip was scanned Right O Left MOST Second Follow up DXA Bone Density Dr m Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 39 MOST DXA HOLOGIC BIOGRAPHY INFORMATION Instructions Study Coordinator Fill out this form completely with the official study information Make 2 photocopies Keep the original and send 2 copies to the DXA lab with the study participant DXA operator Create or modify the Hologic Biography from this form Do NOT scan the participant if you do not receive this form for every visit Keep one copy and send one copy with the Participant Scan Log to QA Center 2 Visit circle one Baseline Visit Visit Study Coordinator Include a copy of MOST DXA Form with header filled out The DXA operator must complete the MOST DXA form and return to the Study Coordinator for scanning to the UCSF Coordinating Center Acrostic DXA ID number M followed by clinic letter B or I then 5 digit number with NO separators M Birth date Month Day Year Sex circle Male Female Weight to nearest pound lb To convert 2 2 times kg pounds and round up if needed Height
3. Soc Sec Pat ID MB01010 Comment Follow up Visit Scan Code B01 Zip DOB 10 20 30 Sex M Weight 160 Height 5 9 Ethnic W Ref MD MOST 3 2 Hip scans 3 2 1 Hip acquisition Baseline The appropriate HOLOGIC user s guide should be consulted for the proper hip scanning and analysis procedures Clarifications and exceptions for the MOST Study are noted below l Generally use the default Fast Array for all participant scan acquisition An exception may be made for large participants if the Array mode provides a better quality scan It is not possible to give an exact cut point It is suggested to use Array mode when the participant weighs 170 pounds or more the anatomy being scanned is very thick or the scan image has moth eaten look The decision to use Array rather than Fast Array may be made at the discretion of the operator Array may be used without first trying Fast Array 2 The RIGHT hip is the preferred hip unless it has hardware If the right hip is not appropriate to scan scan the left hip 3 If both hips have hardware or for some other reason a hip scan can not be obtained the participant can be in the study Fill out the appropriate MOST form to inform the study coordinator that no hip scan was performed All missing scans must be accounted for 4 No metal or plastic object should remain in the scanning area Check for jewelry coins or other objects in the hip pockets zippers buttons rivets belts o
4. 3 Leave the Current Height and Weight blank For Operator enter the last three numbers of the MOST staff ID code of the DXA operator performing the scans See your Study Coordinator for a staff ID code Figure 2 MOST Patient Biography Screen for Windows Based Software Patient Biography Last Name Acrostic First Name Middle Initial Sex F Ethnicity White DOB Month Patient ID MI00010 Day Identifier2 Year Referring Physician MOST Menopause Age Weight lb Height in Patient Comment VISIT 1 Figure 3 MOST Patient Confirmation Screen for Windows Based Software Patient Confirmation Patient s Current Height in Patient s Current Weight 16 Operator 101 3 1 3 Patient biography Follow up The Patient Biography was created in the Hologic database for the MOST baseline scan Do not create a new biography for the follow up visit The participant s current weight and height must be entered in the database Do not presume that the weight and height has not changed since baseline Be sure to use the numbers zero 0 and one 1 not the letters and T when entering numerical data into the Patient Biography fields and vice versa Whole Body and Hip DXA Bone Density Version 1 0p May 2009 MOST Whole Body and Hip DXA Bone Density Operations Manual page 11 Figure 4 MOST Follow up Visit Patient Biography Screen Patient Biography Information Name SMITH JOHN
5. 7 scan It is not possible to give an exact cut point It is suggested to use Array mode when the participant weighs 170 pounds or more the anatomy being scanned is very thick or the scan image has eaten look The decision to use Array rather than Fast Array may be made at the discretion of the operator Array may be used without first trying Fast Array NOTE Default mode is the only mode available for whole body scans Be sure to completely fill out the appropriate MOST forms before and after scanning the participant see Appendix B This includes the Participant Scan Log and any forms provided by the Study Coordinator Follow up Use the same scan mode e g fast array or array as was used on the baseline scan 3 1 Participant biography 3 1 1 Patient biography Baseline Be sure to use the capital letter I not the number one 1 when entering character data into the Patient Biography fields Be sure to use zero 0 and one 1 and not the letter or lower case letter T or capital letter I when entering numerical data into the Patient Biography fields The Study Coordinator will send a DXA Biography Form with the participant listing the acrostic MOST ID sex and ethnicity to be used in the Hologic biography If you do not get this form insist on having it before scanning the participant It is important that this information match the study records Do NOT ask the participant Get the
6. and repeat the scan If the scan also falls outside the limits and or the CV of the BMD exceeds 0 60 contact both Hologic and the QA Center 7 After the spine and hip phantom scans have been analyzed and added to the QC database delete the scans from the hard drive Note the Whole Body phantom scans should be archived to the clinic optical and copied to the traveling optical disks before being deleted Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 21 from the hard drive 8 Check the system drift weekly by pressing R while viewing the plot The slope of the calculated regression line should be within the range of the standard deviation shown If the drift is greater than the standard deviation contact both Hologic and the QA Center 9 Generate a printout of the daily phantom plots BMD BMC and AREA for hip and spine once a week on your designated day This will facilitate detection of long term drifts as well as short term inconsistencies Store these plots in a QC log book 10 Original printouts including the scan results of the most recent phantom QC plots BMD BMC and AREA for hip and spine are to be sent to the QA Center with each batch The date range for the plots should cover the previous 12 months to the present 11 Perform a dbArchive at least once a week and store at the clinical site Disks may be rotated monthly
7. are exceptions to this Pack the materials carefully The optical disk should be placed in a plastic bag and then wrapped in plastic bubble wrap to avoid damage Batches containing the optical disk should be sent via FedEx UPS Assign a number to each batch of BMD data beginning with the first batch of BMD materials sent Start with batch number 001 The batch number should be the clinic identifier followed by this 3 digit number For follow up use the next sequential number e g if the last baseline batch number was 057 the following batch number will start with 058 Complete a BMD Batch Checklist indicating the number and which materials are included in the batch and send it along with the batch materials The materials in the batch should be bundled separately by type Ship these items every other month on or about the 1 month February April June August October to the following address DXA Coordinator MOST DXA Quality Assurance Center SF Coordinating Center 185 Berry Street Lobby 4 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 30 5 4 Return materials sent by the MOST DXA Quality Assurance Center The QA Center will return the following items to the clinical center after review 1 Annotated printouts of flagged scans random sample scans and any other requested s
8. be archived each day to the clinic opticals and traveling optical disks include 1 All new participant scans acquired since the last archive was performed 2 Allscans that have been reanalyzed since the last archive Note that if a scan needs to be restored and reanalyzed for any reason it will need to be re archived Clinic opticals will remain at the clinical center at all times The traveling opticals will be sent back and forth between the clinical center and the QA Center The clinical centers are responsible for following the archive schedule and for keeping the optical disk archives safe until the end of the study Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 26 5 3 Transfer of data to the MOST DXA Quality Assurance Center Baseline The following items are to be sent to QA Center once a month 1 BATCH RECORD FORM see Appendix B a Assign a number to each batch of BMD data beginning with the first batch of BMD materials sent Start with the clinic code initials then a 3 digit sequential batch number from 001 999 For example the first batch from Birmingham will be numbered B001 the second batch B002 etc For Iowa the first batch will be numbered 1001 the second batch 1002 etc The following are the clinical center codes that will be used for the MOST study Birmingham B Iowa City I b Complete a Batch Record Form indicating
9. dbArchive before any work is done on your QDR 2 If possible contact the QA Center before the repairs or adjustments are made to find out whether additional measures are required 3 Perform baseline 5 follow up 10 scans of the Hologic daily QC spine phantom before if possible and after the repairs or adjustments are made 4 Perform baseline 5 follow up 10 scans of the Hologic daily QC hip phantom before if possible and after the repairs or adjustments are made 5 Send the repair technician s notes and a copy of the completed Hologic Repair Service Upgrade Log to the QA Center with the data transfer sent every baseline or every other follow up month The log should contain complete information on all repairs and upgrades done on your machine Please keep a repair log with your machine 4 5 Hardware software change control Unauthorized hardware software changes must be avoided If for any reason you think you have to change the hardware software or your Hologic service representative recommends a hardware software change contact the QA Center before any changes are made Future hardware software upgrades will be checked by the QA Center in conjunction with Hologic technical support personnel to assure that the upgrade will not adversely affect the study Authorized upgrades must be cleared by the QA Center before installation at the clinical centers Record hardware software upgrades on the Hologic DXA Repair Servic
10. feet inches To convert mm divided by 25 4 z inches 48 inches 4 feet 60 inches 5 feet 72 inches 6 feet 9 Ethnicity Form completed by Print Name Initials Date Whole Body and Hip DXA Bone Density Version 1 0p May 2009 MOST Whole Body and Hip DXA Bone Density Operations Manual page 40 Circle CLINIC Birmingham VISIT Visit 1 MOST DXA Participant Scan Log Visit Iowa Circle Date of Scan DXA ID MI00010 Acrosti c Ex JSMI Scan Type Hologic Scan File number Ex A06010201 Comments Reason for Flag Hip Whole Body Hip Whole Body Hip Whole Body Hip Whole Body Hip Whole Body Hip Whole Body Hip Whole Body Use the same DXA ID that was assigned to the MOST study participant at the baseline visit Whole Body and Hip DXA Bone Density May 2009 Version 1 0p DXA MOST Operations Manual page 41 DXA Batch Record Form DXA Batch Record Form Batch Number ____________ Date Batch Mailed j j B l 001 Sequentially to 999 Month Day Year MOST Circle City Birmingham lowa Staff ID Contents QC Plots Hip amp Spine No Date Printed BMD BMC Area Month Day Year Participant Scan Log amp No Yes Hologic Biography Forms Flagged Hip and No Yes gt Number Whol
11. forms should be available MOST DXA Bone Density form as provided by the MOST Coordinating Center Do NOT photocopy Baseline only DXA Hologic Biography Form to go with participant to DXA clinic Photocopy as needed DXA Participant Scan Log Photocopy as needed DXA Batch Record Form Print form from MOST website Hologic DXA Repair Service Upgrade Log Print form from MOST website Whole Body Air QC Scan Worksheet Photocopy as needed Follow up only Excessive Bone Loss Form Follow up only Excessive bone loss alert letter Master copies of the forms will be provided with this manual Photocopy these forms at your clinical center as needed except the MOST DXA Form or Repeat DXA Form Always keep a copy of any form you send to the QA Center Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 36 MOST DXA Form DXA ari MOST ID E Completed Staff IDs m Draft Office Use Only Month Day Have you ever had a hip surgery for joint replacement or fracture repair O Yes No O Refused Scan right hip On which side did you have hip surgery Right Left 1 Both Scan left hip Scan right hip Do NOT scan either hip Qo Do you have any metal objects or implants in your body such as a pacemaker staples screws plates breast implants etc OYes ODon t Know O Refused a Flag scan for r
12. fracture This bone loss may also be related to other health conditions or could result from use of certain medications We have enclosed both copies of your hip scan your baseline measurement and your last measurement We suggest that you consult with your personal doctor to find out why this is occurring and we would be happy to forward these results to your doctor If you do not have a source of medical care we can provide you with the name of a doctor who specializes in treating osteoporosis in Birmingham Thank you for your time and interest in the MOST study Please do not hesitate to call us if you have questions at and ask for Sincerely Cora Beth Lewis M D MOST Principal Investigator Whole Body and Hip DXA Bone Density Version 1 0p May 2009
13. hip axis length software the top and medial edges of the ROI should be expanded past the acetabulum to include the medial edge of the pelvic bone 4 Inthe event that the global ROI must be expanded to allow complete filling of the bone edges see below in low BMD participants all edges must be at least two steps away from the border of the scan field Bone Edges If the bone edges are not properly determined by the analysis program increase the size of the global ROI by first moving the top border up 10 lines further from the femoral head then by moving the medial border 10 lines further out if possible to include more soft tissue in the analysis Repeat as needed Do not move the bottom or lateral border Do not fill in bone edges manually unless absolutely necessary The software will automatically fill any holes within the bone Occasionally the bursa or tendons surrounding the greater trochanter can be calcified This will produce knobs that can merge with the trochanter and throw off the automatic placement of the four regions Expanding the global ROI will not always separate these from the trochanter and they will have to be manually excluded Flag for review by the QA Center any cases in which you manually alter the bone edge Femoral Midline Unevenness notches in the upper or lower edge of the femoral neck can throw off the femoral midline so that it does not run down the center of the neck This will in turn cause the fe
14. information from the DXA Biography Form provided by the Study Coordinator An example of the PATIENT BIOGRAPHY screen for a participant is shown in Fig 1 Sex and Ethnic fields should be entered as described in the appropriate Hologic user s guide Patient Name Field Please enter the participant s MOST acrostic The acrostic will be provided by the study coordinator Use capital letters in this field The acrostic entered in the Name Field MUST match the official study acrostic that will be provided by the Study Coordinator Do not make up the acrostic yourself Get it from the DXA Biography Form provided by the Study Coordinator Patient ID Field The MOST ID used for tracking participants consists of the capital letter M followed by the capital letter B for Birmingham clinic or capital letter I for lowa clinic followed by 5 numbers Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 8 It is the single most important piece of information associated with each participant and must be entered correctly Do not use spaces dashes or commas Iowa staff must be careful to use the letter I not the number 1 for the second character Use the number keys for the numbers zero and one Consider the sample participant discussed above Suppose the clinical center is Iowa and the five digit number is 00010 then Figure 1 demonstrates the correct method for entering t
15. 12 Follow these procedures for the Whole Body phantom Scan and analyze the phantom three times a week according to the instructions provided by Hologic and Appendix A of this manual COPY the whole body phantom scans to the traveling optical disk then ARCHIVE to the clinic optical before deleting scans from the hard drive The QA Center will retrieve the scans from the traveling optical plot the desired variables and notify the clinical centers of any problems 4 2 Whole body air scan for the QDR 4500 4 2 1 DOS based software A Whole Body WB scan of air i e nothing on the table but a clean pad should be performed once a week The air scan will assess the proper functionality of the QDR 4500 scanner and indicate any potential problems with the x ray beam if present 1 Clear the entire tabletop of any objects and clean the pad of any debris Only the table pad should remain on the table This is critical since the test can detect items as thin as a single piece of Scotch tape 2 Enter a Patient Biography with WB AIR QC SCAN in the Name field Enter the system serial number in the Pat ID field Leave the remaining fields blank Press lt F10 gt when completed Please be certain to use this biography for all future WB air scans Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 22 3 Perform a scan by choosing whole body from the
16. Air Scan time week Baseline Hologic Gold Baseline Traveling Phantoms that Standard Hip Spine and Block mailed to the clinical center and scanned phantoms one time usually near the beginning of the study 4 1 Phantom scans Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 20 Perform the spine and hip QC phantom scans as outlined in the Hologic manual Quality Control Chapter Be sure to scan the hip phantom in Array mode not the default Fast Array mode Fast Array hip scans cannot be added to the QC database The results of these scans should be reviewed locally for abrupt changes in machine performance and the results sent to the QA Center once a month Whole body quality control consists of Hologic whole body phantom scans whole body air scans and tissue bar scans Hologic whole body phantom comes with instructions from Hologic and there are supplemental instructions in Appendix A The instructions for the whole body air scans are in Section 4 2 of this manual The tissue bar comes with instructions from Hologic Points of procedure to note 1 Create only one patient biography per phantom There should be a biography for the Spine Hip and Whole Body phantoms Avoid duplication of phantom biographies by using the patient menu to select the appropriate biography prior to scanning the phantom 2 Use the following instructions
17. Boe E HBoe HBoe HiBone E 5 Press the lt ALT gt lt PRINTSCREEN gt keys to obtain a hard copy of the plotted data If this does not work on your scanner do not print the data COPY the WB AIR QC SCAN to your traveling optical and archive to the clinic opticals Delete the air scan from your hard disk 6 IMPORTANT In the event that the SD exceeds the limit of 2 0 units immediately fax the worksheet to Russell Scott at UCSF FAX 415 514 8150 4 3 Cross calibration of scanners In order to assess accurately the absolute variations in scanner performance between clinical centers a set of study phantoms will be circulated and scanned at each clinical center during the first few months of the study The set includes a Hologic hip spine and block phantom A detailed protocol will accompany the phantoms Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 24 Additionally 1 Iowa sends whole body phantom to UAB 2 UAB scans analyzes once a day for ten days 3 Copy scans to disk and make printouts 4 Send disk printouts to UCSF 5 UAB sends whole body phantom back to Iowa and Iowa does same for 10 days Then Iowa follows usual protocol 4 4 Machine software and service problems If your machine needs to be repaired or if any adjustment has to be made that possibly might affect your data 1 Doa
18. Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 3 2 Study logistics Table 1 summarizes the body composition and bone density scan acquisition schedule A whole body and hip scan will be obtained at the initial and 84 month follow up visit Bone mineral density scans will be performed at the hip and whole body Follow up visit scans will be compared to the MOST baseline visit scans for positioning analysis and excessive bone loss at the hip Table 1 Scan Acquisition DXA Scans Baseline 84 Month Whole Body and Hip X X 2 1 Division of quality assurance responsibilities 2 1 1 Clinical center responsibilities The clinical centers must ensure the overall quality and completeness of the DXA data and that all protocols and procedures are strictly followed Specific responsibilities include the following 1 Require that operators are properly trained and certified If there are state requirements for DXA operators these must be met 2 Identify a chief densitometry operator to train and supervise other operators 3 Perform and review daily QC scans all visits and schedule cross calibration scans of traveling phantoms baseline 4 Assure that proper archiving and back up procedures for participant scans are performed and that archives are stored securely on appropriate archiving media until the end of the study 5 Request and review random samples of scans
19. Have you had any of the following in the past ten days Yes Barium enema o Upper GI X ray series Lower GI X ray series Nuclear medicine scan o Other tests using OF either hip 2 Do you have any metal objects or implants in your body such as a pacemaker staples screws plates breast implants etc IZ ONo ODon t Know Refused a Flag scan for review by DXA Reading Center b Indicate the location of the artifacts Sub regions are those defined by the whole body scan analysis e g left breast implant is in left ribs left hip replacement is in pelvis and left leg Sub regions Hardware Other Artifacts i Head o il Left arm iii Right arm contras dye or radioactive materials Examiner Note If Yes to any responses above reschedule bone density measurement so that at least 10 days will have passed since the tests were performed 4 Was a bone density measurement obtained for a Whole body O Yes No Reason Last 2 characters of scan ID Date of scan Reason b Hip O Metal in hip iv Left ribs Right ribs Vi Thoracic spine vii Lumbar spine Pelvis ix Leftleg Oj OJOJOJOJ O X Rightleg
20. Scan menu Scan the entire length of the table Do not interrupt the scan perform a complete scan 4 With the air scan selected lt ESC gt to the Main Menu Choose the UTILITY option and press lt gt Then choose SERVICE and then PLOT A blank image will appear Press the PgDn key once to move to line 10 The image will appear along with a graph At the bottom of the graph an indicator of the reference wheel segment that produced the data will appear along with an attenuation value a SD Standard Deviation See diagram below LoBone 827 9 4 9 sag 3276 2437 1638 602 8 HiBone This number is the SD of the HiBone value Hi 689 Lo 833 Point 2 Line This number indicates which oine of the scan is being measured For example HiBone 602 8 0 9 The last value 0 9 is the value we want to record It represents the SD of the air values across a scan line The value should not exceed 2 0 units Use the z DOWNARROW key to view 9 additional lines to obtain a better estimate of the SD Record all 10 SD values for HiBone for lines 10 through 19 on the worksheet on the next page Please make photocopies of the worksheet for your use Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 23 WHOLE BODY AIR QC SCAN Clinical Center Serial Number HiBone HiBone H
21. Whole Body and Hip DXA Bone Density MOST Operations Manual page 1 DXA Bone Density TABLE OF CONTENTS 1 encor cL 2 2 Study 3 2 1 Division of quality assurance responsibilities eee ee eee eene een eee 3 211 Clinical center responsibilities eee e eee ee eren ee eere ee eere etta netten seta aee ense eese see 3 2 1 2 MOST DXA Quality Assurance Center responsibilities 4 eee e ecce eerte e eerte eene eanu 4 2 2 Training and certification of MOST DXA operators ee eere ee eee een eee en sette seen aset ta ae 5 2 3 Review of DXA E o 5 2 3 1 Flagged sCans E EE O E EEA EEEE ENE EE EEA E E TE A 6 2 3 2 Random sample and outlier checks e sseessesssesssecssecsocesocesocesccesooesoosscosecossooessosssosesosesscesossssesssse 6 3 DXA scan acquisition and analysis procedureS seesseesscessecsccesccesccesocesocesocesocesocesoossooesooesssesoe 6 3 1 Participant sessen EM 7 3 11 Patient biography Baseline sesssesssesssecssccesccesccesocesocesocesocssocsscoossooescoessosssosssosssosesosessssssesssse 7 3 1 2 Windows Based Software 8 3 1 3 Patient biography Follow 10 3 2 Ie PE E 11 324 Hip ac
22. achieve a consistent projection of the femur After proper rotation attach the leg to be scanned to the angled foot block supplied by the manufacturer The participant should be made as comfortable as possible to reduce the chance of unwanted movements Use a pillow for the head and a small pillow under the knee of the leg not being scanned Maintain the participant at a comfortable body temperature for the duration of the Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 13 scan 10 Instruct the participant to remain still until the end of the measurement Make sure that the leg is not moved during the scan Flag any scans in which the participant has moved and has not been rescanned 11 Print out a hard copy of each scan and file in the participant s folder 3 2 2 Hip analysis Baseline Global Region of Interest The procedures outlined in the appropriate Hologic user s guide are to be followed The points listed below are for emphasis 1 The lateral side of the global ROI should be at least 5 mm 5 lines beyond the outer edge of the greater trochanter to provide sufficient soft tissue for analysis although it should not extend outside the participant s body 2 The bottom edge of the global ROI should be at least 1 cm 10 lines below the lesser trochanter to provide sufficient soft tissue for analysis 3 n order to facilitate the use of
23. ant remove all clothing including shoes and dress them in a hospital gown Check that no metal or plastic objects remain in the scanning area This includes hair clips and pins snaps zippers and buttons Have participant remove any jewelry earrings bracelets watches or rings 2 Position the participant in the center of the scanning table with their head just below the head of the table It is extremely important that the participant is correctly positioned on the exact center of the table The arms should be separated from the sides of the body with the hands placed palm down within a few centimeters of the table edge If the hands do not fit in the scan field tuck the hands under the thighs 3 Place loop of tape around the top of the feet so that the feet are slightly inverted this will help to prevent motion during the scan and create a separation between the tibia and fibula If the feet do not fit in the scan field keep the legs straight and cut the feet from the scan field 4 Verify that the participant is aligned with the scanner axis solid line on the table If during scanning it is apparent that part of the participant s body lies outside the scan field restart the scan 5 The participant should be positioned as comfortably as possible since this reduces the chances of unwanted movements In general try to avoid the use of any pillows or blankets If the participant feels uncomfortable in that position you may use pi
24. be filled out by the UCSF DXA QA Center O Yes we can confirm excessive bone loss The scans are technically correct and the analyses are performed appropriately Yes we can confirm excessive bone loss However the scans were not analyzed properly Please reanalyze the scan s following our instructions and inform the participant of the correct bone loss O The scans provided indicate possible excessive bone loss However a second scan of the site was not performed in this participant Excessive bone loss can only be confirmed after you have obtained a second scan of the region where bone loss is suspected repeat measurement may or may not confirm excessive bone loss O After scan review we cannot confirm bone loss Comments Signature of UCSF DXA QA Reviewer Date of review Month Day Year Version 1 0 12 1 06 Draft Whole Body and Hip DXA Bone Density Version 1 0p May 2009 DXA MOST Operations Manual page 45 Excessive bone loss alert letter December 30 2006 Jane Doe 1234 Market Street Birmingham AL 35201 Dear Ms Doe During your last clinic visit for the MOST study we repeated measurements of your hip bone density Analysis of the results indicated that you have lost bone in the hip at a rate greater than 2 per year since your baseline measurement was made This loss is greater than average for a person your age and may indicate an increased risk of
25. cans are returned to the clinical center with explicit instructions for reanalysis as necessary The clinic then reanalyzes the problem scans according to the QA Center s recommendations The reanalyzed scan is then saved and re archived and the database at the clinical center is automatically updated An original printout of the reanalyzed scan is sent to the QA Center with the next data transfer to verify compliance 2 Traveling optical 3 Any recommendations for service additional phantom scans etc as necessary based on the quality control data Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 31 Appendix Hologic Whole Body Phantom Protocol I Phantom Assembly Before lifting or transporting the phantom break it down into its individual components Use care the impact force of a phantom component dropped from table height can cause severe injury particularly if the impact is delivered through one of the phantom s beveled edges Having another person help move the phantom components is strongly recommended A thin gray PVC sheet is attached to the large white plastic piece that contains the two plastic locating pins This HDPE PVC combination is the bottom layer base of the phantom Position it on the scanner table such that the PVC is on the bottom i e the gray PVC is in contact with the table pad and the two plastic locating pins project out o
26. e Body Printouts Reanalyzed Scan No Yes gt Number Printouts Other Scans No Yes 3 Number Specify Traveling Optical No Yes Repair Service Upgrade No Yes Log amp Hologic Service Report if service performed DB System Archive Disk No Yes Date Archived f Send once end of visit for 1 t me total Day after all participants have been scanned at visit 1 Certification Scans No Yes Please printout amp mark Certification We need 10 of each scan type i e hip whole body from each staf Can be split between batches MOST Staff ID Number of Scans Scan Type MOST Forms Version 1 0 6 03 02 pjm PM65 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 DXA MOST Operations Manual page 42 DXA Repair Service Log Hologic DXA Repair Service Upgrade Log Instructions Please complete this log thoroughly and attach a copy of the Hologic service report Send copy with monthly DXA data transfer Keep one copy with your scanner in your own repair log Clinic City Date problem s encountered QDR System Month Day Year Serial d Describe problem Were there hardware software changes or upgrades Yes please describe Was the Hologic operational during the problem period Q Yes No 4 4 Did problem affect scans How long was the Hologic out of Yes No service Please describe inc
27. e Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 2 1 Introduction The purpose of this manual is to describe the DXA body composition and bone mineral density BMD quality assurance programs for the clinical centers participating in the MOST study It provides information specific to the Hologic QDR 4500A and QDR 4500W scanner operating under DOS or Windows based software and is intended as a supplement to the appropriate Hologic Users Guide To use this manual effectively it is essential to have read and understood the entire Hologic QDR 4500 User s Manual The study densitometry operators are required to have participated in a Hologic QDR 4500 training session and should be familiar with all instrument features and procedures discussed in the Hologic User s Manual During the study any questions regarding procedures that arise should be directed to MOST DXA Quality Assurance Center University of California San Francisco 185 Berry Street Lobby 5 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Fax 415 514 8150 IMPORTANT Unauthorized changes in scanner software or personnel can have a large impact on the integrity of study data If for any reason changes in any of these areas are anticipated please contact the MOST DXA Quality Assurance Center in San Francisco in advance for further instructions Whole Body and Hip DXA Bone
28. e Upgrade Log Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 25 5 Data management 5 1 Hard copies of scans 1 The clinical center is responsible for maintaining original hard copies of all scans performed during the study Keep the original printouts in the participant s scan printout folder The following printed reports are needed for each scan Hip Print the standard report Whole body Print the BMD and body composition reports 2 pages 5 2 Electronic scan archive Each clinical center works on a four optical disk system two clinic opticals and two traveling opticals Both clinic optical disks and one traveling optical are updated at the end of each day The other traveling optical may be in transit between the QA Center and clinical center Please be sure to re archive any scans that you reanalyze after you have completed the reanalysis In order to use the optical disks efficiently do not save or archive scans individually Saving scans in batches e g at the end of a day will ensure the longevity and efficient usage of the optical disk space The QDR software will give a warning message when optical capacity has been reached Fill side A of the disk first then fill side B See the Hologic User s Manual for detailed instructions One clinic optical should be a dedicated MOST optical used only for archiving scans acquired for MOST Scans to
29. e region markers Vertical or horizontal shifts of these regions by one or more pixels can greatly alter the final values of the analysis Global Region of Interest 1 The width and height of the global ROI must be the same as that used on the baseline 2 The dotted lines from the baseline defining the bone region should overlay the follow up as Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 15 closely as possible Occasionally there are small changes in adduction and rotation of the leg that were not eliminated by rescanning The region surrounding the neck should have the best fit 3 Ifthe global ROI cannot be moved to the appropriate position because it is too large the baseline scan will have to be reanalyzed with a properly reduced global ROI Then the follow up should be analyzed comparing it to the reanalyzed version of the baseline Flag cases in which the baseline had to be reanalyzed 4 Use Control End to accept the global ROI and bone mask Bone Edges If the bone edges do not fill in properly on the follow up analysis first the baseline will have to be reanalyzed with a larger ROI and then proceed with the comparison scan analysis Femoral Midline Unevenness notches in the upper or lower edge of the femoral neck can throw off the femoral midline so that it does not run down the center of the neck This will in turn cause the f
30. emoral neck box to twist If the midline looks like it might be off or the box is twisted on either the baseline or follow up scan it may be necessary to adjust the bone mask e g filling in neck notches deleting the ischium in order to obtain appropriate positioning of the midline The position of the midline itself should not be altered If you have made changes to the scan such as filling in bone in order to alter the midline or if the midline 15 still off flag these cases for review by the QA Center Femoral Neck Box If the current location is optimally matched to the location of the neck box of the baseline analysis use it unchanged 1 If the current location is not optimally matched to the location of the neck box on the baseline adjust the current region to achieve maximum correspondence The size of the neck box must be the same on both baseline and follow up 2 If the current location cannot be satisfactorily adjusted while maintaining the same sized neck box reanalyze the baseline within the constraints outlined above 3 It is most important to have the neck box location and size correspond as closely as possible If you cannot get the neck boxes to match flag the scan for review by the QA Center Ward s Triangle If the Ward s triangle box appears on the follow up scan in a significantly different position than on the baseline or if after reanalysis of the baseline its location is different than that of the original base
31. eview by DXA Reading Center b Indicate the location of the artifacts Sub regions are those defined by the whole body scan analysis e g left breast implant is in left ribs left hip replacement is in pelvis and left leg Sub regions Hardware Other Artifacts Head Left arm iii Right arm iv Left ribs Right ribs i Thoracic spine ii Lumbar spine Pelvis ix Left Leg Right leg Page 27 Have you had any of the following in the past ten days Yes a Barium enema b Upper GI X ray series Lower X ray series o d Nuclear medicine scan Other tests using contrast dye or radioactive materials Examiner note If Yes to any responses above reschedule bone density measurement so that at least 10 days will have passed since the tests were performed 4 Was bone density measurement obtained a Whole body Reason OYes ONo Last 2 characters of scan ID messe Metal in hip Severe degenerative disease O Other Please specify Last 2 characters of scan ID EN peores Which hip was scanned O Right O Left b Hip O Yes Draft MOST Clinic Visit Workbook Version 1 0 8 13 2002 pjm Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manua
32. f the plane of the table towards the ceiling Place the large white plastic piece on top of the phantom base using the locating pins as a guide The piece should be placed such that the beveled edge forms a V with the base Next place the medium size white plastic pieces on the phantom again forming with the two beveled edges of the middle pieces Then place the small white plastic pieces on top forming another V with the small pieces The final assembly will form a pyramid see Figure 1 side view This is the only valid configuration for the phantom measurement other configurations including adding materials to the phantom removing pieces of the phantom scanning the phantom upside down etc violate the intended use of the phantom and may produce invalid results II Phantom Positioning Carefully position the whole body phantom in the center of the scanner table with the head of the phantom at the head of the table Allow 24 61cm of empty air space at the head of the table Carefully position the phantom parallel with the long axis of the table using the table pad markings as a guide When properly centered there will be a constant 3 5 8 9 cm gap between the side of the phantom and the front and back limits of the QDR 4500 scanner table see Figure 1 Head of Scanner Table Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operat
33. from each clinical center 6 Once per month baseline and every other month follow up on or about the 17 of the month February April June August October send the following materials to the QA Center a Printouts of plots of the daily QC data b Updated copies of participant scan and machine repair logs c Original printouts of flagged scans d Original printouts of other requested scans e Traveling optical disk with all newly acquired scan files obtained since the last data transfer Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 4 7 Reanalyze centrally reviewed scans as requested by the QA Center 8 Assure proper functioning of hardware software and request service from Hologic a Notify Hologic and the QA Center of any machine or software problems or if the QDR machine is being relocated b Record machine software problems and service on the Hologic DXA Repair Service Upgrade Log c Perform 5 baseline 10 follow up QC phantom scans before if possible and after service d Perform 5 baseline 10 follow up QC phantom scans before and after machine relocation 9 Contact the QA Center with any questions or problems that cannot be dealt with in the batch mailings 10 Send a complete dbArchive at the end of each visit 1 end of baseline visit and end of follow up visit after all participants have been scanned 2 1 2 MOST DXA Qual
34. h the annotated printouts sent by the QA Center that indicated the problems requiring reanalysis You MUST also send back the reanalyzed scan images on the traveling optical 6 TRAVELING OPTICAL DISK Send electronic copies of all scans acquired and reanalyzed since the last data transfer Archive scans using the COPY feature Do not archive the scans individually as this will use up the disk space rapidly 7 HOLOGIC DXA REPAIR SERVICE UPGRADE LOG with a copy of the Hologic service report if service has been done This form only needs to be sent for months where service or upgrades were performed 8 DB ARCHIVE or System Backup An archive of the participant database dBarchive in DOS based software and System Backup in Windows based software will be sent at the end of the visit This means one time at the completion of the visit unless otherwise instructed by the QA Center Please include the following on the disk label MOST DB ARCHIVE Clinic name Date of Archive If more than 1 disk label each disk as above and 1 of 3 2 of 3 etc Please note The QA Center will use the most recent scan data for participants whenever there are multiple analyzed scans from the same date in the data base Please notify us if there are exceptions to this Pack the materials carefully The optical disk should be placed in a plastic bag and then wrapped in plastic bubble wrap to avoid damage Batches containing the optical disk should be sen
35. he Most ID within the Pat ID field 100010 Comment Field Enter VISIT 1 in this field Use all capital letters Operator field Enter the staff ID code provided by your study coordinator You will always use this code when scanning MOST participants Use uppercase for characters Ref MD Field Enter MOST in this field Use all capital letters Leave all other fields blank Figure 1 MOST Patient Biography Screen for DOS Based Software Patient Biography Information Name Acrostic Soc Sec Pat ID 100010 Comment VISIT 1 Operator I01 Zip DOB Sex F Weight Height Ethnic W Ref MD MOST 3 1 2 Windows Based Software Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 9 Details about the Biography entry screen of the QDR for Windows software can be found in the QDR for Windows User s Guide Chapter 6 Managing Patient Records Please use the following instructions to enter your MOST Biographies in the Windows software An example of the PATIENT BIOGRAPHY and PATIENT CONFIRMATION screens for a participant with acrostic JSMI scanned by staff with MOST staff number 01 etc at Iowa are shown in Figures 2 and 3 Last Name Field Enter the participant s MOST acrostic The acrostic will be provided by the study coordinator Use capital letters in this field The acrostic entered in the Last Name Field MUST match the offic
36. ial study acrostic that will be provided by the Program Coordinator Do not make up the acrostic yourself Get it from the form provided by the Study Coordinator First Name and Middle Initial fields Leave blank Patient ID Field The MOST ID used for tracking participants consists of the capital letter M followed by the capital letter B for Birmingham clinic or capital letter I for Iowa clinic followed by 5 numbers It is the single most important piece of information associated with each participant and must be entered correctly Do not use spaces dashes or commas Iowa staff must be careful to use the letter I not the number 1 for the second character Use the number keys for the numbers zero and one Use uppercase for characters Consider the sample participant discussed above Suppose the clinical center is Iowa and the five digit number is 00010 then Figure 2 demonstrates the correct method for entering the Most ID within the Patient ID field MI00010 Sex Ethnicity Enter information Referring Physician Field Enter MOST Patient Comment Enter VISIT 1 Use all capital letters Leave all other fields blank PLEASE NOTE THE STAFF ID CODE and CURRENT HEIGHT AND WEIGHT ARE ENTERED AS FOLLOWS Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 10 After entering or selecting a Biography the Patient Confirmation screen will appear Figure
37. ions Manual page 32 Figure 1 Layout of Whole Body Phantom positioned on the QDR 4500 scanner table Also shown the fully assembled phantom viewed from the side Note that the amount of empty space between the side of the phantom and the sides of the table will vary depending upon scanner model III Data acquisition Scanning the whole body phantom 1 Make sure that the phantom is centered is parallel to the long axis of the table and is correctly oriented with respect to the head of the table 2 Enter Whole Body Phantom in the Name field of the Patient Biography where XXXX is the phantom serial number including any letters found on the phantom label Enter XXXX in the Pat ID field of the Patient Biography where XXXX is the phantom serial number including any letters found on the phantom label 3 Remove all artifacts from the table surface Extraneous objects in the scan field will interfere with the measured results in an unpredictable fashion 4 Select the standard Adult Whole Body scan mode commonly employed at your facility Accept the default scan length and scan width Perform a complete scan of the entire table surface including the phantom Do not interrupt the scanner during the measurement 5 Carefully inspect the scan image to ensure that the phantom was 1 centered ii parallel to the long axis of the scanner table and iii the phantom s head appears at the top of the image If the scan image appear
38. ions Manual page 33 B Specific Instructions Hologic QDR systems Follow the instructions in Sections II and III of Appendix A to acquire a technically adequate scan of the Whole Body phantom Restore the appropriate scan from the Hologic diskette labeled SAMPLE ANALYSES WB PHANTOM or Whole Body Phantom Analysis Template to the analysis workstation see Table 1 for the correct scan to restore for your QDR model Select the newly acquired WB Phantom scan Then use the Compare feature to register the ROI cutlines of the sample scan to the newly acquired scan of the WB Phantom Once the have been matched as nearly as possible complete the analysis and print the first and last pages of the report Archive the baseline measurement for safekeeping but do not delete it from the analysis workstation All future whole body phantom measurements will be compared to the initial baseline measurement After the initial measurement the sample scan restored from the sample diskette should be deleted Archive Whole Body Phantom scans to both the clinic and traveling opticals then delete the scans from the hard drive Table 1 Scans to restore for a given QDR model number WB PHANTOM SCAN RESTORE RDISMODEDNUMBER FROM SAMPLE DISK 1000W 1500 2000 Pencil beam 1000 1500 2000 Pencil WB Phantom 2000 Fan Beam 2000 Fan WB Phantom 4500W 4500W WB Phantom 4500A 4500A WB Phantom V Interpretation of measured values The phantom measure
39. iteria Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 19 Follow up Time Point Actual Rate of Change for Total Spine or Total Hip BMD Compared to Baseline Follow up Visit Greater than or equal to 15 If EBL is found rescan by having the participant get off and on the table repeat the positioning and scanning analysis and check again for EBL This will necessitate analyzing the follow up scans while the participant is still on the scan table Whether or not the scan confirms EBL fill out the Excessive Bone Loss Form see Appendix B and notify the study site investigator about procedures for providing the participant and their physician with the appropriate MOST Sample Excessive Bone Loss letter see Appendix B These letters can be altered by the Principal Investigator as desired Do not discuss the presence or implication of EBL with a participant until the principal investigator has been informed confirmed the bone loss and has informed the onsite staff how to proceed 4 Scanner quality control Monitoring of machine performance throughout the study is the joint responsibility of the clinical centers and the QA Center Table 3 lists the quality control procedures and schedule Table 3 Quality Control Scanning Schedule Vocal Hologic Spine Phantom 3to5 times week and always on a day that participants are scanned Whole Body
40. ity Assurance Center responsibilities The following are the responsibilities of the QA Center 1 Write and maintain the quality assurance operations manual 2 Promptly review the QC phantom scan data received from each clinical center in order to identify surges or drifts in machine performance 3 Incorporate new participant data into the study wide database 4 Review certification and flagged scans and return results to each clinical center 5 Baseline Request and review random samples of scans from each clinical center 6 Baseline Arrange for cross calibration of all DXA instruments using traveling phantoms 7 Baseline Prepare quality control summary reports for MOST Steering Committee review 8 Identify possible sources of error and suggest possible solutions However the QA Center will not be responsible for the solution of a hardware or software problem that will rest with the clinical center and Hologic Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 5 Any questions or correspondence regarding this manual or the technical aspects of the DXA measurements should be directed to MOST DXA Quality Assurance Center SF Coordinating Center 185 Berry Street Lobby 5 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Fax 415 514 8150 2 2 Training and certification of MOST DXA operators To obtain consistent resul
41. l page 37 Repeat DXA Bone Density Form EH d MOST ID Acrostic Date Form Completed Staff ID Office Use Month Da Year Was the hip scan repeated pe O No Date scan performed EN j EBEN Month Day Year b Last 2 characters of Scan ID Reason Mark only one O Original scan unacceptable e g corrupted O Scan lost Other Please specify d Which hip was scanned Right hip Left hip 2 Was the whole body scan repeated l1 O No a Date scan performed LII Month Day Year b Last 2 characters of Scan ID Reason Mark only one O Original scan unacceptable e g corrupted O Scanlost O Other Please specify Draft Page1 MOST Repeat DXA E Version 10 9 25 2002 pjm pmm Whole Body and Hip DXA Bone Density Version 1 0p May 2009 MOST Whole Body and Hip DXA Bone Density Operations Manual page 38 83 TR DXA Bone Density Follow up Visit MOST ID Acrostic Date Form Completed Staff ID Month Year Day 1 Have you ever had a hip surgery for joint replacement or fracture repair O Yes O No Scan right hip O Refused Right On which side did you have hip surgery Left Both Scan left hip Scan right hip Do NOT scan 3
42. lem Follow up If the problem involves comparison to the baseline scan include a copy of the baseline scan The printouts will be reviewed for standard positioning and analysis procedures and returned to the clinical centers with instructions for reanalysis if appropriate Often these problem scans have been analyzed correctly and will not require further action 2 3 2 Random sample and outlier checks Periodically during the study a random sample of scans and scans with exceptionally high or low BMD outliers will be reviewed by the QA Center In the initial phases of the study a relatively large number of scans will be checked to verify site performance These checks may result in requests for reanalysis by the QA Center 3 DXA scan acquisition and analysis procedures Standard scanning and analysis procedures for the hip and whole body bone density measurements are described in detail in the Hologic QDR 4500 User s Manual Some of the information from the Hologic manual is repeated in this manual for emphasis Please note however that some of the scanning evaluation protocols for this study differ from those detailed by Hologic Baseline Generally use the default Fast Array for all participant scan acquisition An exception may be made for large participants if the Array mode provides a better quality Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page
43. line placement flag the scan for review by the QA Center Trochanteric Line The trochanteric line should intercept the bone edge at the same point on all scans Matching is easily done during the compare analysis especially since you will have the baseline to consult during the compare 3 3 Whole body scans Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 16 The HOLOGIC Operator s Manual should be consulted for the proper whole body scanning and analysis procedures Clarifications and exceptions for the MOST Study are noted below 3 3 1 Whole body acquisition Before scanning the participant have a printout of the baseline scan available if this 1s a follow up scan and refer to the baseline printout for positioning of the participant this is to ensure consistent scanning of the same area Careful positioning and visual comparison of the current scan with baseline are essential for producing precise measurements Use the DXA Bone Density TELEForm baseline Appendix B or DXA Bone Density Follow up Visit TELEForm follow up see Appendix B to determine and document artifacts Store the DXA Bone Density TELEForm in the participant s clinic binder do not send to the QA center The following points should be followed when possible However if this is a follow up visit repositioning the same as baseline always takes precedence 1 Have the particip
44. llows for the head only after the upper half of the scan is done You may then carefully place a pillow under the head of the participant without causing motion artifacts This procedure should be practiced with the participant before scanning If the participant cannot lie flat at all without the aid of a pillow due to kyphosis use a radio lucent pillow 6 If the participant is very tall try to include their feet in the scan by placing their head Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 17 near the very top of the table 7 Instruct the participant not to move until the end of the measurement 8 Print out a hard copy of each scan and file in the participant s folder 3 3 2 Whole body analysis Baseline 1 Locate the horizontal shoulder line just below participant s chin 2 The vertical shoulder lines should bisect the shoulder joints and separate the arms from the trunk Avoid including any arm soft tissue in the body ROIs It is acceptable for the arms to be out of the scan region if this is the only way to position them 3 Align the spine ROI with the curvature of the spine if possible Divide the spine at the T12 L1 disc space 4 The horizontal line above the pelvis should be just above the iliac crest The angled lines defining the pelvic triangle should bisect the femoral neck 5 vertical line between the legs should ru
45. luding time period ee Describe the action taken Was the problem resolved 1 Yes No gt Explain Date problem resolved Please describe how problem was resolved Was recalibration of the Hologic necessary Yes Were phantom scans performed after the repair or the recalibration 7 Yes No Did you notice a change in the phantom values Yes MOST DXA Forms Version 1 0 6 03 02 PM65 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 DXA MOST Operations Manual page 43 Whole Body Air QC Scan Worksheet Clinical Center Serial Number HiBone HiBone 14 HBoe i E MEUM HiBone ENSE X HBoe 3 9 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 DXA MOST Operations Manual page 44 B s ES Excessive Bone Loss Form MOST ID Acrostic Date Form Completed Month Day Year Suspected Excessive Bone Loss Checklist Examiner Note Please make sure that this form is accompanied by all of the items listed below O Printouts of the baseline and all follow up scans of the hip O Printouts of the rate of change report s you created for the hip O Copies of baseline and all follow up scans of the hip on floppy disk To
46. ments should be printed out placed in a logbook file and kept at the clinic center The QA Center will plot selected variables periodically from the scans sent on the traveling optical and notify the clinic center of any problems Please note a correction to the Biography in the following printout The phantom serial number should be in the ID field I D 001 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 34 HOLOGIC oJun 13 11 33 1997 327 x 1581 Hologic QDR 4568A S N 3886 Whole Body U8 28a 3 88538978 Name Comment I D 5 5 8 ZIP Code Operator BirthDate Phusician Fri Mau 38 13 51 1997 WHOLE BODY PHANTOM 661 7 Sex Ethnic Height Weight Age Image not for diagnostic use TOTAL BMC and BMD CU is lt 1 8 1 823 Region firea R firm L Ribs R Ribs T Spine L Spine Pelvis L Leg R Leg SubTot Head TOTAL L Arm 113 48 112 29 41 81 42 21 31 06 71 67 138 21 89 19 93 17 724 29 127 802 851 31 1 888 BMC Ccm2 grams gms cm2 132 56 134 78 36 69 39 91 33 46 77 02 185 48 119 73 123 91 883 54 311 82 1115 36 E IM m HOLOGIC 1 888 BMD PNB RE ORR Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 35 Appendix Study Forms The following
47. moral neck box to twist If the midline looks like it might be off or the box is twisted it may be necessary to adjust the bone mask e g filling in neck notches in order to obtain appropriate positioning of the midline The position of the midline itself should not be altered If you have made changes to the scan such as filling in bone in order to alter the midline or if the midline still seems off please flag these cases for review by the QA Center Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 14 Femoral Neck Box If the default neck box provided by the Hologic program looks reasonably placed leave it unchanged 1 Whenever possible use the maximum width of the neck box default The neck box should be perpendicular to the neck axis Always anchor the neck box at the inflection or turning point of the greater trochanter On some scans it will be necessary to lengthen the neck box in order to get correct placement of the neckbox If the maximum area of the neck that can be covered by the femoral neck box is less than 1 cm the participant should be rescanned with special care taken to improve the rotation and degree of abduction of the leg Since such a narrow neck box would be only 2 to 3 lines wide you will only rarely have a problem with this constraint 2 If the area of the neck region is less than 2 5 cm attempt to increase the width of
48. n between the participant s feet and evenly divide the legs The lateral leg lines should be moved to include as much of the thigh soft tissue as possible without crossing the hands If necessary it is okay to cross the hands 6 Sub region cut line placement should be such that left right symmetry is maintained i e placement of lines on the left side of the body should match those on the right 7 Print out a hard copy of each scan and file in the participants folder Follow up Display the baseline evaluation using the COMPARE feature and compare it to your current image on the screen Match the location of the region markers as closely as possible to the baseline measurement Optimally matched in this context means that the markers should be at the same position between the body regions as on the baseline image If adjustment cannot be done satisfactorily it will be necessary to reanalyze the baseline scan If it is necessary to reanalyze the baseline measurement all subsequent follow up measurements should be reanalyzed using COMPARE 3 4 Scan flagging criteria Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 18 General e Scan has unusual appearance or is difficult to analyze Any of the following in scan field either in the bone or soft tissue Unusual anatomical variations Surgical hardware Participant motion during scan Su
49. onic copies of all scans acquired and reanalyzed since the last data transfer Archive scans using the COPY feature Do not archive the scans individually as this will use up the disk space rapidly REANALYZED SCANS Send original printouts of all scans that have been reanalyzed according to the QA Center instructions since the last data transfer Attach the annotated printouts sent by the QA Center that indicated the problems requiring reanalysis You MUST also send back the reanalyzed scan images on the traveling optical Copy of the Hologic Repair Service Upgrade Log with a copy of the Hologic service report if service has been done DBARCHIVE An archive of the participant database dbArchive will be sent at the end of each visit i e after the last participant has been scanned at Follow up Visit Please include the following on the disk label MOST Follow up Visit DB ARCHIVE Batch Clinic name Date of Archive If more than 1 disk label each disk as above and 1 of 3 2 of 3 etc Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 29 Diskette Label for DB Archive MOST DB Archive Date Clinic Batch Diskette No of Please note The QA Center will use the most recent scan data for participants whenever there are multiple analyzed scans from the same date in the data base Please notify us if there
50. perimposed buttons pins zippers pacemakers vitamin pills etc e Bone edges have been altered in any way Follow up only ROI used on follow up is different size than used at baseline e Follow up only Follow up scans cannot be reasonably matched to baseline analysis Hips e Femoral midline is not aligned and cannot be corrected by following the analysis procedures as outlined in the MOST operations manual e Neck box width reduced from default Ward s triangle persistently located outside of Ward s region difficulties in redefining search region Analysis program repeatedly fails to place regions appropriately major operator interaction required for analysis Whole Body e Internal or external artifacts that cannot be removed e Participant motion without rescanning these scans are extremely susceptible to motion artifacts Unable to fit both arms in scan field e Follow up only Significant changes in positioning between baseline and follow up scan 3 5 Follow up only excessive bone loss procedures Excessive Bone Loss EBL is defined in Table 2 Use the Hologic Rate of Change plots to determine the actual not annualized percent loss between the baseline and follow up visit For DOS based software this software is in use at the beginning of the follow up visit Do NOT use the first Rate of Change plot that appears this is annualized Instead hit Home key to get the actual Rate of Change Table 2 EBL Cr
51. quisitlOn saavsveasetesnassounsveaseess 11 3 22 Hip analysls niece ebenso eo vae aote toos o anon er rb onse ee VOS Sa an eet oS 13 3 3 Whole body SCANS aen 15 3 31 Whol ACGUISILION 16 332 Whole body analysis eire oto oo coss ne eee ep oo soos en ees bonore seo ae ee va obse esso ee ens 17 3 4 SCAN MAG CNG criteria NM G M 17 3 5 Follow up only excessive bone loss procedures esee ee ee ee eere sten nest 18 4 Scanner duality Control oer aere eere sued sedbadenevessnsesdsencosesessesesssessssossees 19 4 1 Iupiter R 5045 19 4 2 Whole body air scan for the QDR 4500 4 eee ecce esee ee eee eene seen sete en setate ae etna 21 42 1 Sepe e eo ES 21 4 3 Cross calibration Of SCann rs Fee tona eo aeree aire fn PUER e Kioii seni vU 23 4 4 Machine software and service problems 24 4 5 Hardware software change control eee ee ecce ee eee ee
52. r any other clothing fasteners as well as hip and back braces 5 Keep the participant s hands out of the scanning area by placing them well away from the hips Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 12 6 Ensure rotation of the hip by holding the knee and the ankle when positioning the leg Optimum positioning of the leg is most important to achieve a consistent projection of the femur Scan the other side if you cannot rotate the foot inward due to pain small or missing lesser trochanter on the scan image indicates proper hip rotation 7 After proper rotation attach the leg to be scanned to the angled foot positioner supplied by the manufacturer 8 The participant should be made as comfortable as possible to reduce the chance of unwanted movements Use a pillow for the head Maintain the participant at a comfortable body temperature for the duration of the scan 9 Instruct the participant to remain still until the end of the measurement Make sure that the leg is not moved during the scan Rescan if necessary Flag any scans in which the participant has moved and has not been rescanned 10 Print out a hard copy of each scan and file in the participant s folder Follow up 1 Refer to the baseline hip scan printout Use the DXA Bone Density Follow up Visit TELEForm see Appendix B to determine and document which side to scan Sto
53. re the DXA Bone Density Follow up Visit TELEForm in the participant s clinic binder do not send to the QA center If the opposite hip from baseline must be scanned perform the acquisition and analysis according to the baseline MOST DXA operations manual instructions Refer to the baseline hip scan printout Position the hip in exactly the same position as baseline even if the baseline positioning was not optimal In particular the hip rotation must be the same The best way to check hip rotation is to be sure that the lesser trochanter has the same size shape and location on the follow up scan as at baseline If it is impossible to reproduce the positioning from baseline e g pain worsening arthritis produce the best possible scan Flag the follow up scan write the problem on the scan printout and send copies of both the baseline and follow up scan to the QA center Refer to the baseline hip scan printout Use the same scan mode e g fast array or array as was used on the baseline scan No metal or plastic object should remain in the scanning area Check for jewelry coins or other objects in the hip pockets zippers buttons rivets belts or any other clothing fasteners as well as hip and back braces Keep the participant s hands out of the scanning area by placing them well away from the hips Ensure rotation of the hip by holding the knee and the ankle when positioning the leg Optimum positioning of the leg is most important to
54. s satisfactory proceed to the analysis section If not carefully reposition the phantom according to the instructions in Section II and repeat the scan 6 After receipt of the whole body phantom scan the phantom four 4 times a day for the first week 20 scans This will allow the setting of a consistent mean for monitoring performance and comparison purposes Note that the whole body phantom scans can NOT be added to the QC database The QA Center will plot and check the data and notify the clinical centers of any problems 7 After the first 20 scans are performed scan the phantom three times a week IV Analysis A General Comments The goal of the analysis is to carefully delineate the various body regions in a standard and reproducible fashion so that measured results will reflect instrument performance not variations in analysis techniques Of particular importance are the placement of the head ROI cutline and the cutlines that delineate the ribs since these two regions affect global body composition and BMD It is essential that the baseline measurement is technically adequate and that the analysis is performed by direct comparison to the sample analysis on the Hologic diskette labeled SAMPLE ANALYSES WB PHANTOM or Whole Body Phantom Analysis Template Use the sample scan for your model of scanner see Table 1 Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operat
55. soon as the first 10 follow up scans have been completed 2 3 Review of DXA scans Scan analysis quality will be ensured by a central review of flagged whole body scans and flagged hip scans Scan analysis quality will be ensured by a central review of some analyzed participant scans Whenever scans are to be reviewed centrally Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 6 1 Anoriginal printout and electronic copy of the scan should be sent to the QA Center Write the reason for the flagged scan on the scan printout and on the Participant Scan Log 2 Itis the responsibility of the operator to reanalyze the scan according to QA Center comments and return a printout of the reanalyzed scan with an electronic copy to the QA Center for verification Procedures for compiling and forwarding scans to the QA Center are outlined in Section 5 Data management 2 3 1 Flagged scans Any scans that appear unusual or difficult to analyze should be flagged for review by the QA Center Guidelines for flagging scans are listed in Section 3 4 Scan flagging criteria Flagged scans should be sent to the QA Center every month at baseline and every other month at follow up on or about the 1 of the month February April June August October Note the reason s for flagging on the MOST Participant Scan Log and on the original printout for clarification of the prob
56. t via FedEx UPS The materials in the batch should be bundled separately by type Ship these items monthly to the following address Be sure to put a personal name in the first line DXA Coordinator MOST DXA Quality Assurance Center SF Coordinating Center 185 Berry Street Lobby 4 Suite 5700 San Francisco CA 94107 1762 Telephone 415 514 8096 Follow up Whole Body and Hip DXA Bone Density Version 1 0p May 2009 MOST Whole Body and Hip DXA Bone Density Operations Manual page 28 The following items are to be sent to QA Center by the 1 of every other month February April June August October 1 PRINTOUT Send a printout of the most recent plots of the QC database spine and hip BMD BMC and AREA The plots are reviewed at the QA Center and problems are reported back to the clinic PARTICIPANT SCAN LOG Send a copy of the written participant scan log covering participants scanned since the last data transfer Use the log sheets to flag individual scans for review at the QA Center SCANS FOR REVIEW Send original printouts of certification scans flagged scans random sample scans and any scans requested for review by the QA Center Please write directly on the printout the reason the scan was flagged requested or being sent These scans will be triaged visually based on the original printouts and analyzed on the Hologic workstation if necessary TRAVELING OPTICAL DISK Send electr
57. the neck box to the maximum possible while still avoiding inclusion of the trochanter ischium or femoral head and acetabulum In order to obtain maximum size of the neck box the ischium may be deleted 3 If the default neck box partially extends into the trochanter or femoral head and acetabulum adjust its location or size while maintaining the maximum possible area 4 The Hologic software is sometimes unable to provide an appropriate placement of the neck box and other regions This can occur if the projected neck axis is too short or the neck is too close to the ischium Soft tissue between the neck and ischium will be read as bone and the automatic placement of the femoral midline will fail If this happens use the procedure described in the appropriate Hologic user s guide for deleting the bone of the ischium Deleting this will not adversely affect the analysis as this bone is not included in the reported regions of interest Trochanteric Line The trochanteric line should intercept the bone edge just below the lateral aspect of the greater trochanter There is no need to correct minor deviations up to about 3 pixels Follow up Load the baseline scan onto the hard disk Display this baseline evaluation using the COMPARE feature along with the current scan to be analyzed It is important to realize that proper comparison of a follow up hip scan to its baseline depends upon maintaining the identical size and relative position of th
58. the number and which materials are included in the batch and send it along with the batch materials Keep a copy 2 QC PRINTOUT Send a printout of the most recent plots of the QC database spine BMD BMC and AREA and hip BMD BMC and AREA Include at least a year s worth of data in the plot The plots are reviewed at the QA Center and problems are reported back to the clinical center 3 PARTICIPANT SCAN LOG and DXA HOLOGIC BIOGRAPHY INFORMATION forms Send a copy of the written Participant Scan Log covering participants scanned since the last data transfer Use the log sheet to flag individual scans for review at the QA Center Include a copy of the DXA Hologic Biography Information form for each participant listed on the Participant Scan Log 4 SCANS FOR REVIEW Send original printouts of flagged whole body and hip scans certification scans and any scans requested for review by the QA Center Please write directly on the printout the reason the scan was flagged requested or being sent e g Certification These scans will be triaged visually based on the original printouts and analyzed on the Hologic workstation if necessary Whole Body and Hip DXA Bone Density Version 1 0p May 2009 Whole Body and Hip DXA Bone Density MOST Operations Manual page 27 5 REANALYZED SCANS Send original printouts of all scans that have been reanalyzed according to the QA Center instructions since the last data transfer Attac
59. to create the phantom biographies The phantom serial number is on the phantom label It may have letters in front of the numbers If this is a new biography put in both letters and numbers The NAME field contains the type of phantom and the phantom serial number indicated by XXXX Spine Phantom Hip Phantom XXXX Whole Body Phantom XXXX The PAT ID field contains the phantom serial number indicated by XXXX XXXX 3 Scan each phantom on top of the pad Ensure alignment with the scanner axis by using the laser cross hairs 4 Add the spine and hip phantom scan data to the QC database immediately after completing scanning and analysis See the Hologic manual Quality Control Chapter section Adding Data to QC Database Note the Whole Body phantom and Whole Body Air scan data can not be added to the QC database 5 Be sure to scan the hip phantom in Array mode not the default Fast Array mode Fast Array hip scans cannot be added to the QC database See the Hologic manual Quality Control Chapter section Setting Up a New QC Plot Graphs Follow the directions to set up the mean and limit lines for the hip QC plot After the set up is done scan the hip phantom two times a week 6 Use the plot feature to verify that the spine and hip phantom BMD BMC and AREA values of your scanner are within normal limits It is best to plot at least one year of data If the most recent scan falls outside the limits reposition the phantom
60. ts the densitometry operators must be aware of possible sources of error that may affect data collection and analysis Only those operators who have been certified through Hologic training and the QA Center review are allowed to perform the scanning and analysis for this study Anyone performing scans for the MOST study must meet the following requirements 1 Read and understand both the Hologic QDR4500 manual and this manual 2 Successfully complete a Hologic QDR4500 training course 3 Satisfactory review of each operator s initial scans by the QA Center It is the clinical center s responsibility to ensure that all of the above certification criteria are met as new operators are brought into the study Since the Hologic central training sessions are held infrequently there may be several months delay between when a new operator is hired and when certification is complete Personnel not meeting these requirements may not scan participants without close supervision by a certified operator unless specifically authorized by the QA Center Follow up In order for an individual operator to be certified to perform scans of a given skeletal site the first 10 follow up scans done on study participants at each skeletal site for each operator must be sent to the QA Center for review Printouts of the corresponding baseline scans must accompany the follow up scans Printouts of the scans should be sent to the QA Center at the address listed above as

Bone Density (DXA) (Version 1.0p, May 2009)

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