Polysomnography in Multicenter Trials Nuts and Bolts

1. Polysomnography in Multicenter Trials(Nuts and Bolts) Samuel T. Kuna, M.D. Pulmonary Critical Care & Sleep Section Philadelphia VAMC and University of Pennsylvania

2. Standardization of Policies and Procedures In-lab versus out-of-lab testing Selecting PSG equipment Training and certifying personnel Identifying Medical Alerts Establishing scoring criteria Standardizing study forms and surveys Developing a Quality Assurance Program

3. Sleep Heart Health Study Policies and Procedures Manual www.jhsph.edu/shhs/manual/procedures/

4. Sleep AHEAD Study Ancillary study of Look AHEAD clinical trial Primary aim: to determine the effect of weight loss on sleep disordered breathing in obese individuals with type 2 diabetes mellitus PSG in a total of 200 participants prior to and one and two years following randomization to weight loss program or conservative care Primary outcome parameter: RDI 4 sites: Brown, Pittsburgh, St. Lukes, Penn

7. PSG Reading Lab Objectives Standardize the performance of sleep studies among the Clinical Sites Score all records, generating reports of needed PSG outcome measures Provide information to participants and Data Coordinating Center Identify Medical Alerts Participate in on-going quality assurance and control to maintain: High levels of technical performance of tests at the Clinical Sites Scoring accuracy in the PSG Reading Laboratory

8. In-Lab vs Out-of-Lab PSGs in a Multicenter Study Advantages of in-laboratory fewer lost studies better quality studies Disadvantages of in-laboratory Long wait times for in-laboratory slots Expense of in-laboratory study Increased patient burden Different equipment in different labs

9. Networking Different Equipment in Different Labs European Data Format software allows interchange of PSG files from one computer system to another Many systems can export files into EDF Systems with EDF import software: Sandman (Mallinckrodt) Embla (ResMed/Flaga) Compumedics Use same montage, sensors, filters, and digitization rates across labs

10. In-Lab vs Out-of-Lab PSGs in a Multicenter Study Advantages of out-of-laboratory Same equipment in different labs Greater flexibility in scheduling Decreased participant burden Disadvantages of out-of-laboratory Greater number of lost studies Poorer quality of studies Expense of in-laboratory study

12. Training and Certification of PSG Set-up Personnel at Clinical Sites One technician from each site trained at a 2 day central training session held at the PSGRL before the start of recruitment PSGRL certification requires successful performance of at least 3 practice studies Technicians trained at the PSGRL will train technicians at their local sites To become certified, locally trained technicians must successfully perform at least 3 practice studies

13. Training and Certification of PSG Set-up Personnel at Clinical Sites (Continued) Certified technicians lose certification if 2 consecutive PSG studies are unacceptable The PSGRL medical director visits each site prior to subject recruitment and at least once each year of the project to reinforce training

14. SHHS Criteria for Apneas and Hypopneas Apnea: A > 10 sec reduction in airflow or chest wall movement to below approximately 25% of �baseline� amplitude Hypopnea: A > 10 sec reduction in airflow or chest wall movement to below approximately 70% of �baseline� associated with a 3% desaturation or arousal SHHS uses thermistor to measure airflow

15. Hypopnea � A Floating MetricRedline et al. AJRCCM 161:369, 2000

16. Identifying and Responding to Medical Alerts Establish detailed policies and procedures for response to specific Medical Alerts Medical Alerts triggered during home visit at Clinical Sites Medical Alert for Immediate Referral Medical Alert for Urgent Referral Medical Alerts triggered by PSG results at PSGRL Medical Alert for Urgent Referral

22. Quality Assurance/Control of PSG Data Collection Training/certification of technicians performing PSG Forms standardized across clinical sites Monthly reports on the quality of PSG data specific to each technician, monitor, and site Identify sites and technicians who have do not have 85% of studies with a grade of �good� or better Recertify sites and techs failing to meet the acceptable level of performance Schedule monthly conference calls with technicians Establish e-mail chat room for technicians

23. Quality Assurance Program for PSGRL Scoring Weekly quality assurance meetings in the PSGRL reviewing interesting/problem studies Maintain minutes for these meetings and print copies of problem epochs discussed On alternate weeks, one hour of paired scoring (PSG scorer scoring, Chief PSG technologist observing) Chief PSG Tech and PSG Scorer rescore 10% of the PSG studies, randomly selected by DCC, to monitor inter- and intra-scorer reliability

24. Tracking Results From Scorers and Sites by Data Coordinating Center DCC reports on a regular basis to the PSGRL the overall means of the following parameters for PSG scorer and Clinical Site: RDI sleep stage percentage arousal index Differences detected in scoring are discussed at weekly QA meetings

25. Standardization of Policies and Procedures In-lab versus out-of-lab testing Selecting PSG equipment Training and certifying personnel Identifying Medical Alerts Establishing scoring criteria Standardizing study forms and surveys Developing a Quality Assurance Program

27. Polysomnography in Multicenter Trials Samuel T. Kuna, M.D. Pulmonary Critical Care & Sleep Section Philadelphia VAMC and University of Pennsylvania