DXA OPERATORS’ MANUAL IMPAACT 2010 - PDF Document

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  1. DXA OPERATORS’ MANUAL IMPAACT 2010 Shepherd Research Lab (SRL) University of Hawaii Cancer Center Population Sciences in the Pacific Program 701 Ilalo Street, Honolulu, Hawaii (USA) 96813 Contact info: +1 (808) 356-5792 / +1 (808) 440-5231 (HST) Email: srania@hawaii.edu or lkazemi@hawaii.edu 1 Version 1.0

  2. TABLE OF CONTENTS INTRODUCTION TO QUALITY ASSURANCE ........................................................................................................................... 3 HOLOGIC DXA OPERATOR’S SIGN OFF LOG .......................................................................................................................... 4 A. INTRODUCTION TO THE IMPAACT 2010 PROTOCOL ....................................................................................................... 5 A.1New Subject Registration ...................................................................................................................................................... 5 B. DXA SCAN ACQUISITION- ADULT ....................................................................................................................................... 6 B.1AP Spine Scans: ..................................................................................................................................................................... 7 B.2Hip Scans ............................................................................................................................................................................... 7 C. DXA SCAN ACQUISITION- INFANT ..................................................................................................................................... 8 C.1 Whole Body Scan ................................................................................................................................................................. 8 C.2Infant Lumbar Spine Scans: ................................................................................................................................................. 10 D. QUALITY CONTROL DATA (LONGITUDINAL AND CROSS-CALIBRATION) ............................................................. 11 D.1 Normal Longitudinal QC Procedures (in-house) ................................................................................................................ 11 D1.1Hologic Spine Phantom (The assumption is made that a biography already exists) ...................................................... 11 D1.2 Air Scan Procedure (Table Top Radiographic Uniformity) .......................................................................................... 12 D.2Copying and Archiving: ..................................................................................................................................................... 12 D.3 Scanner Cross-Calibration Plan .......................................................................................................................................... 12 D.4 DXA Bone Densitometer Report (BDR) ............................................................................................................................ 12 E. OPERATOR QUALIFICATIONS ............................................................................................................................................. 13 F. DATA SECURITY..................................................................................................................................................................... 13 G. DATA EXPORT to University of Hawaii Cancer Center (UHCC)-SRL ................................................................................... 13 G.1 Study Subject Data ............................................................................................................................................................... 13 G.2Instrument Quality Control Data .......................................................................................................................................... 13 H. DXA SITE NUMBERS and STUDY COORDINATORS ....................................................................................................... 14 I. Appendix I.1 Bone Densitometer Report (BDR) ........................................................................................................................................ 15 2 Version 1.0

  3. INTRODUCTION TO QUALITY ASSURANCE This manual serves as the official Hologic DXA Operator's Guide for the IMPAACT 2010 study. The purpose of this manual is to standardize DXA scanning acquisition procedures between all study sites participating in 2010 study. The success of the DXA portion of the study depends on several factors, including the qualifications and dedication of the scanner operators, clear specification and understanding of the study requirements as set forth in this manual, and good lines of communication between the sites participating in the study, the UHCC Quality Assurance Center (SRL- Shepherd Research Lab), and members of the IMPAACT 2010 Core Study Team. This manual is intended to serve as the DXA operator's guide for the IMPAACT 2010 study and builds upon (rather than replaces) the operator training and documentation provided by the Hologic Corporation. It is expected that each person performing scan acquisition for IMPAACT 2010 is familiar and competent with the scanning system employed at their study site. In addition, the material in this manual should be read and understood. In the first six months of the start of the study, SRL will certify of the study at each site that each DXA operator is qualified by performing an expert review of 3 images of each DXA scan type: adult spine and hip; and infant whole body and spine. These scans can be from volunteers or from recent patients with patient identifiers removed. If the site is unable to perform these scans on volunteers or patients prior to study initiation, then the site will receive preliminary approval to start the study and will be asked to send scans from the first participation enrolled for final certification. Note: DXA scanner table weight limit is 136-181 kg (300 to 400 lbs.) depending on the model. Please check your scanner’s weight limit. Also, no changes or modifications without prior notification to SRL; this includes hardware, software upgrades and scanner relocation. Please send your notification by email to SRL. Procedures, if required before changes, will be described using SRL-specific forms. Any questions or comments concerning the DXA procedures of this study should be directed to the UHCC SRL clinical coordinator below. Other questions regarding the study protocol should be directed to the site Study Coordinator (list of sites, page 14). Stephanie Rania UHCC/SRL Attn: IMPAACT 2010 701 Ilalo Street B503 Honolulu, HI 96813 Tel: +1 (808) 356-5792 e-mail: srania@hawaii.edu 3 Version 1.0

  4. HOLOGIC DXA OPERATOR’S SIGN OFF LOG Dear DXA Operator and Study Coordinator, UHCC/SRL and IMPAACT 2010 require that all DXA operators using the Hologic densitometer read and fully understand the Hologic DXA Operator’s Manual for IMPAACT 2010. Please print your name, copy, sign and date this form to confirm completion of this requirement. Please keep the original at your site to document any future changes in personnel. Principal Investigator: ________________________________ Study Coordinator: ________________________________ Site: _________________ DXA Operators: Printed Name Signature DD/MMM/YY Initials 4 Version 1.0

  5. INTRODUCTION TO THE IMPAACT 2010 PROTOCOL DXA Procedures Introduction: IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1 infected pregnant women initiating either a dolutegravir (DTG)- containing antiretroviral regimen or an efavirenz (EFV)- containing antiretroviral regimen at 14-28 weeks gestation. The study will compare the regimens with regard to safety and virologic efficacy during pregnancy. Our role at UHCC/SRL is to assess bone mineral density/content at 26 weeks post-partum for infants and 50 weeks post-partum for mothers. The mother and infant’s bone density will be tracked with the use of Dual X-Ray Absorptiometry (DXA) scans. Mothers will receive a spine and hip scans at, and the infants will receive a whole body and spine. This section describes the DXA procedures to be followed for the duration of the study. Please read this manual carefully before scanning participants. These instructions assume you are familiar with correct scanning procedures. Schedule of DXA Scans Participants DXA exams Spine Hip Whole Body Spine One-time visit (post partum) Mothers 50 weeks Infants 26 weeks Figure 1: Schedule of DXA scans A.1 New Subject Registration Enter the site number (the site where the subject was recruited (5 digit number, if your site number is not 5 digits then enter the appropriate number of 0’s to make it a 5 digit number, example: Soweto’s site number is 8052, you would enter 08052) in the Last Name field (all sites numbers are on page 14). Leave the First Name field blank. Enter the 8-digit subject code in the Patient ID field exactly as it is entered on the IMPAACT 2010 DXA tracking form. For this reason, you should always obtain the identification number from the Study Coordinator to ensure accuracy. Date of Birth (DOB) and Sex should be entered in the appropriate fields. Ethnicity should be entered for all participants. Enter appropriate height and weight. All leading zeroes must be included. Be sure to use zeroes (Ø) and not the letter "O" when entering the subject information in any of the fields. 5 Version 1.0

  6. ETHNICITY: enter LAST: [Site number] FIRST: leave blank Enter Sex and DOB PATIENT ID: [8 digit subject code] Figure 1: Biography Figure 1: Biography B. DXA SCAN ACQUISITION- ADULT The following sections describe in detail the SRL’s requirements for acquiring adult subject scans for the IMPAACT 2010 study beyond those mentioned in the Hologic operator’s manual. In order to get the most consistent participant results it is important to follow consistent procedures in acquiring all scans. These include the following: 1.Use the same scan mode for each type of scan throughout the study. 2.Remove all radio-opaque objects from the scan area (under-wire bras, jewelry, belts, etc.). 3.The subject should be dressed in a hospital gown or scrubs wearing only underwear and, if necessary, thin socks. A thin sheet may be placed over the subject for warmth. 4.Ensure correct positioning of the subject. 5.Ensure that no movement occurs during scanning. 6.Monitor the scan during acquisition. If positioning is not correct, or the subject moves, etc., abort the scan, reposition the subject if necessary and restart the scan. NOTE: When scanning a subject it is important to keep in mind that it is much less time consuming to rescan the subject immediately if a problem is detected, rather than having to recall the subject for a repeat of the scan on another day. Please note any problems with scan acquisition in the Comment field of the DXA scan form. 6 Version 1.0

  7. B.1 AP Spine Scans: 1.Select Fast Array scan mode. 2.Keep the scan width and length set to the default settings*. 3.Scan the Lumbar spine to include L1 through L4. Make sure that the AP spine scan includes both iliac crests at the bottom of the image and at least one vertebra with ribs at the top (Figure 3). To assist in positioning the spine correctly, use the spinal positioning block. Ensure optimal participant positioning by consistently using the same positioning cushions for each scan. 4. Confirm that the subject’s back and pelvis are flat against the tabletop. If the Hologic positioning block is too large and raises the pelvis and lower spine off the table, use pillows or standard radiographic positioning blocks under the knees and legs for proper flexion. 1st set of ribs Iliac crests visible Straight and Centered 5 vertebral bodies visualized. *The common default length is 8 inches or 20 cm, depending on the set up of a particular scanner. When a participant measures 170 cm in height, the length of the scan may be increased by 4 cm to assure inclusion of the crests and the first set of ribs. Figure 3: Properly Positioned Adult AP Spine Scan B.2 Hip Scans 1.Scan the LEFT hip. (If for any reason, e.g. history of fracture of the left hip, surgery to replace all or part of hip joint, existing disease -such as osteoarthritis, osteonecrosis, anatomical malformation, the left hip cannot be scanned, please scan the right hip.) 2.Select Fast Array scan mode. Keep the scan width and length set to the default settings. 3.Make sure the leg to be scanned is properly rotated and abducted. Ensure optimal subject positioning by consistently using the hip scan positioning fixture for every scan. Always position the subject’s leg by applying rotating force abovethe knee. This will ensure that the hip itself is rotated, not just the lower leg. Proper rotation and abduction will alleviate many analysis problems. With optimal positioning the lesser trochanter will be barely visible (Figure 4). 7 Version 1.0

  8. Femur straight and rotated properly Lesser Trochanter barely visible Nicely centered Figure 4: Properly positioned adult hip scan C. DXA SCAN ACQUISITION- INFANT C.1 Whole Body Scan 1.Choose the Infant Whole Body scan mode. Keep the scan width and length set to the default settings as the default length of 92 cm (36 inches) is adequate. Only half the length of the table will be scanned during this scan. However, the scan time is about the same as the adult scan as the detector array is moving slower for better image resolution. 2.A heat lamp may be useful to keep the scan area warm and /or darken the room. 3.To save time and decrease the amount of stimulation to the infant while the table is being centered, please do the following. Manually move the detector array system to the upper right hand corner of the table which is close to the starting point of the scan before placing the infant on the table. This is especially important on model “W” scanners. 4. 5.Position the subject in the center of the table aligned with the long axis of the scanner, head near the head end of table. The subject’s head should face straight up if possible, not turned to the left or right. The head should be 5 centimeters from top of the scanning area. A rolled towel may be placed around the infant’s head to help keep it straight. 8 Version 1.0

  9. Figure 5: Positioning of infant for WB scan 6.Monitor the scan during acquisition for subject movement. If there is only slight movement, allow the scan to complete and then repeat the scan. Do not make more than 3 attempts to acquire a satisfactory scan. ***Submit all completed scans to SRL**** Figures 6, 7: Infant with towel around the head/tape across knees and darkened room Figure 8: Properly positioned infant whole body: Correct alignment, head straight, feet together, and hands on table. This is an acceptable positioning of an infant whole body scan. 9 Version 1.0

  10. C.2 Infant Lumbar Spine Scans: 1.Select AP Lumbar Spine scan mode and uncheck the Use Default Scan Mode check box. 2.In the Select AP Lumbar Spine Scan Mode window, select Fast Array. It should not be necessary to change the default scan length for Infant Spine Scans as 15 cm (6 inches) should be adequate. 3.Confirm that the infant’s back and pelvis are flat against the table top. 4.Scan the Lumbar spine to include L1 through L4. Make sure that the AP spine scan includes both iliac crests at the bottom of the image and at least one vertebra with ribs at the top. 5.Inspect the image as it is being acquired. Hit Stop Scan when T12 is visible. 6.If there is only slight movement, allow the scan to complete and then repeat the scan. Submit all completed scans to SRL. 7.There will be motion artifact from breathing so don’t get confused. 8.Do not make more than 3 attempts to acquire a satisfactory scan. At least one set of ribs Sacrum Figure 9: Properly positioned AP spine scan Figure 10: Positioning for spine scans 10 Version 1.0

  11. D. QUALITY CONTROL DATA (LONGITUDINAL AND CROSS-CALIBRATION) Scanner Quality Control (QC) procedures are used to monitor scanner performance throughout the course of the study. Longitudinal QC procedures consist of daily procedures used to monitor the performance of a single scanner over time. Cross–calibration procedures are used to monitor scanner variation from machine to machine. An additional QC measure is the use of the "DXA Bone Densitometer Report" (see G and page 17). The DXA operator completes and sends this report monthly to UHCC in addition to the QC scans (Air scans and Hologic Spine Phantom) to the FTP (see FTP Quick Reference Guide). D.1 Normal Longitudinal QC Procedures (in-house) This study will make use of data obtained by your standard daily QC procedures using the Hologic Spine Phantom and a Table Top Radiographic Uniformity Test (Air Scan procedure). Typical Schedule for Phantom Scanning – Longitudinal QC Sunday Monday Tuesday Hologic Spine Phantom Wednesday X Thursday X Friday Saturday X X X Air Scan D1.1 Hologic Spine Phantom (The assumption is made that a biography already exists) 1.Make sure that the phantom serial number is entered in the Pat ID field. The phantom number may be read from the label on the side of the phantom. 2.Scan the Hologic Spine phantom at least every day that a study subject is scanned, but at a minimum of three days per week for the duration of the study. 3.These scans are analyzed automatically and added to the QC database. 4.Review the QC plot for BMD. If the BMD for L1-L4 falls outside acceptable limits, re-scan the phantom. If the BMD from the second scan also falls outside the limits, call for service. If the BMD from the second scan falls within the limits, continue with normal scanning for the day. 11 Version 1.0

  12. D1.2 Air Scan Procedure (Table Top Radiographic Uniformity) Perform a scan of the table once per week. This is an automatic procedure called “Table Top Radiographic Uniformity.” No biography needs to be created. Remove everything from the table and perform a scan of the entire table using the whole body scan mode. Analysis: automatic The computer will provide you with the results of a pass/fail. If it fails, repeat the scan. If it fails again, call service. Note: If the global standard deviation (SD) is less than 2.0, the scanner is functioning properly. If the results are above 2.0, please repeat the air scan and review results. If the SD remains over 2.0, please send an email to Stephanie Rania for immediate review. No further analysis should be performed on these scans. D.2 Copying and Archiving: Use Copy for copying scans to transfer media. Archive to your site’s regular archive modality. D.3 Scanner Cross-Calibration Plan In order to accurately assess differences in scanner performance among investigator sites, cross-calibration phantoms will be brought to each site by a SRL representative at least once during the course of the study. Coordination will be made in advance between the UHCC Quality Assurance Center and each site for this cross-calibration phantoms visit. Detailed scanning (10 scans per phantom on the same day) and analysis will be done using the following phantoms: Hologic Block Phantom, Hologic Femur Phantom, European Spine Phantom and Whole Body Phantom. This procedure will be conducted by the SRL representative during their 1-2 day visit. D.4 DXA Bone Densitometer Report (BDR) The BDR is completed by the site operator at the end of each month and submitted to SRL either by fax, email or uploading it to the FTP. It provides a record of additional information about each study scanner. The BDR tracks scanner maintenance and repairs as well as operator changes, which are then reviewed by the SRL. The scanner serial number and the Hologic spine phantom serial number are critical identification numbers. For reference purposes, an original blank BDR form is supplied with this DXA Operator’s Guide. Remember to keep your own copy for reference. 12 Version 1.0

  13. E. OPERATOR QUALIFICATIONS All operators must be qualified by the QA Center prior to scanning any study subjects. Qualification consists of Webinar and on-line exam provided by the UHCC QA Center and the QA Center’s evaluation of printouts of 3 adult AP spine scans and 3 adult hip scans acquired before the study and analyzed by the operator. If possible, send 3 infant AP spine scans and 3 infant whole body printouts from volunteers or other subjects before the study begins. If this is not possible, the tech will be given a provisional certification and pediatric scans from study participants will be evaluated as certification scans. Each study operator should provide a copy, if available, of their manufacturer’s training certificate and license to the QA Center. Please forward with a copy of the Hologic Operator’s Sign off Log found on page 4 as soon as possible after receiving and reviewing this Procedures Manual. When a new operator joins the study, please follow the above instructions. F. DATA SECURITY Subject data and DXA scans will be uploaded to SRL via the UHCC- FTP website (see FTP Quick Reference Guide document). For data security, archive your scan files on a regular basis. The archive should be stored at another site other than the scanner room. The System Backup function is used to back up your Hologic database. The Hologic database contains all biography, report summaries and location information for all patients scanned on your system. Your site should perform a System Backup on a weekly basis. G. DATA EXPORT to University of Hawaii Cancer Center (UHCC)-SRL G.1 Study Subject Data All subject scans for all visits are to be uploaded to our secure UHCC-FTP (Appendix I) website for analysis by SRL group on a monthly basis. Please send an email notifying Stephanie Rania (srania@hawaii.edu) once the data has been uploaded. Remember to follow all the steps on the flow sheet, FTP Quick Reference Guide. G.2 Instrument Quality Control Data Instrument Quality Control data should be sent to UHCC at the end of each month. QC data transfers should consist of the following: ●Completed DXA Bone Densitometer Report (BDR) (page 15) to via email to SRL ● QC scans of the Hologic Spine phantom and Air scans should be uploaded to the FTP at the end of each month. 13 Version 1.0

  14. IMPORTANT: Changes in scanners, software, or location of scanners can have a large impact on the integrity of study data. For this reason, such changes are NOT ALLOWED for the duration of this study without prior notification of SRL and IMPAACT 2010 leadership team. Requests for changes to scanners may be made by telephone or e-mail to SRL (Stephanie Rania, +1 (808) 356-5792, srania@hawaii.edu or Leila Kazemi at +1 (808) 440-5231, lkazemi@hawaii.edu). H. DXA SITE NUMBERS and STUDY COORDINATORS Site Number Site Name Site Location Study Coordinator (Name, email) 31890* Harare Family Care Harare, Zimbabwe 1) Lynda Stranix, lstranix@uzchs-ctrc.org 30303 St. Mary’s (not a DXA site) 2) Sukunena Maturure, sjmaturure@uzcrc.co.zw 30306 Seke North (not a DXA site) 30300 Umlazi Durban, South Africa Vani Chetty, Chettyv1@ukzn.ac.za 8052 Soweto Johannesburg, South Africa Nasreen Abrahams, abrahamsn@phru.co.za 30293 MUJHU Kampala, Uganda Enid Kabugho, ekabugho@mujhu.org 8950 FAM-CRU Cape Town, South African Jeanne Louw, jeannes@sun.ac.za 30301** Blantyre Blantyre, Malawi Hazzie Mvula, hmvula@jhu.medcol.mw * Site 31890 serves at the DXA site for all Zimbabwe sites **Site 30301 no longer a DXA site (11/15/18) 14 Version 1.0

  15. I. Appendix I.1 Bone Densitometer Report (BDR) OPERATORS SHOULD SEND THIS FORM ALONG WITH QC DATA ACCORDING TO INSTRUCTIONS FOR EACH SCANNER. ___________________________________________________________ DXA Bone Densitometer Report • IMPAACT 2010 Site number and code_________________________ Scanner Serial Number ___________ Hologic Spine Phantom Number ____________ 1) Has a new / different scanner been used for any study patients? If so, what make of scanner was used? _____________________________________ Was scanner change approved in advance by UHCC-SRL 2) Has there been any software change? Old software version: _________New software version: _________Date installed: _________ Was software change approved in advance by UHCC-SRL? 3) Were there any operator changes? Operator Departed _____________________________ ___________________________________________________ ____________________________________________________ __________________________________________________ Added / of Change ______________ Date Date of Manufacturer's Training ____________ ____________ ____________ ____________ _________ 4) Were there any maintenance/recalibration/repair problems? ___Yes ___No If yes, indicate below. Please attach a copy of the service report if available. Service/Maintenance performedDate of Service _____________________________________________________________________________ _____________________________________________________________________________________ ____________________________________________________________________ 5) Additional comments (Use another sheet if necessary) Main Operator: _________________Date: ____________Telephone:__________________ 15 Version 1.0