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IIR 04-021 – HSR&D Study

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IIR 04-021
Cost Effective Strategy to Evaluate Veterans with Sleep Apnea
Samuel T. Kuna MD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, PA
Funding Period: February 2006 - September 2010

BACKGROUND/RATIONALE:
Portable monitors are commercially available to diagnose veterans with suspected obstructive sleep apnea (OSA). However, their application to home testing is not widely accepted because it is not known whether home testing, when compared to conventional in-laboratory testing, is cost effective and produces similar clinical outcomes.

OBJECTIVE(S):
The specific goals of the proposed research were to compare the functional impact, cost, and cost-effectiveness of evaluating veterans with suspected OSA using home versus in-laboratory testing.

METHODS:
296 veterans with suspected OSA were randomized to management using either home testing or standard in-laboratory testing. Home testing consisted of an overnight recording with a type 3 portable monitor (Embla) followed by at least 3 nights using an autoCPAP apparatus (Philips). Participants diagnosed with OSA were treated with continuous positive airway pressure (CPAP). Aim 1 was to determine if veterans with suspected OSA who receive home testing have the same functional outcomes and the same adherence to subsequent CPAP treatment as veterans receiving in-laboratory testing. The primary outcome measure was the global score on the Functional Outcomes of Sleep Questionnaire (FOSQ), a disease-specific quality of life questionnaire. Hypothesis 1: Following 3 months of CPAP treatment, there would be no clinically significant reduction in functional outcomes, with an a priori non-inferiority delta of -1 point, and no clinically significant decline in mean CPAP adherence, with an a priori non-inferiority delta of -0.75 hr/day, in veterans receiving home versus in-laboratory testing. Aim 2 was to compare the differences in cost and quality-adjusted life years saved (QALYS) between home versus in-lab testing to estimate a cost-effectiveness ratio. Veteran preference was assessed with the EuroQol (EQ-5D) and Health Utilities Index 2 (HUI). Hypothesis 2a: Average total health-care delivery cost would be lower for veterans receiving home testing relative to those receiving in-lab testing. Hypothesis 2b: Because we believe that at-home testing will have lower costs and equivalent outcomes, we were 90% confident that the cost per QALY ratio comparing at-home testing with in-lab testing would be less than $100,000.

FINDINGS/RESULTS:
The mean functional outcome score improved 1.74 +/- 2.81 in the home group (p<0.001) and 1.85 +/- 2.46 in the in-lab group (p<0.0001). The lower bound of the one-sided 95% non-inferiority confidence interval was -0.54. The mean hours of daily positive airway pressure adherence over the 3-month intervention was 3.5 +/- 2.5 hr/day in the home group and 2.9 +/- 2.3 hr/day in the in-lab group (p=0.08). The lower bound of the one-sided 95% non-inferiority confidence interval was 0.03. Improvements in the scores on the mental health component of the SF-12, the Epworth Sleepiness Scale, and a depression questionnaire (CES-D) following 3 months of CPAP treatment were significant within both groups but similar between groups.

IMPACT:
The finding that veterans receiving home versus in-laboratory testing have similar outcomes will lead to wider acceptance of home portable monitor testing and increase veterans access to care.

PUBLICATIONS:

Journal Articles

  1. Kuna ST. Home portable monitoring for obstructive sleep apnea. Sleep medicine clinics. 2011 Sep 1; 6(3):293-307.
  2. Kuna ST, Gurubhagavatula I, Maislin G, Hin S, Hartwig KC, McCloskey S, Hachadoorian R, Hurley S, Gupta R, Staley B, Atwood CW. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. American journal of respiratory and critical care medicine. 2011 May 1; 183(9):1238-44.
  3. Sunwoo B, Kuna ST. Ambulatory management of patients with sleep apnea: is there a place for portable monitor testing? Clinics in Chest Medicine. 2010 Jun 1; 31(2):299-308.
Conference Presentations

  1. Kuna ST. Can the polysomnogram provide guidance for selection of therapy for OSA - which treatment for which patients? Paper presented at: Associated Professional Sleep Societies, LLC Annual Meeting; 2014 Jun 2; Minneapolis, MN.
  2. Atwood CW, Kuna ST, Little KC, Hin S, Gupta R, Gurubhagavatula I, Glick H. Cost-effectiveness of home management of obstructive sleep apnea: the Veterans sleep apnea treatment trial. Paper presented at: American Thoracic Society Annual International Conference; 2014 May 19; San Diego, CA.
  3. Kuna ST. Are full PSG necessary for sleep apnea diagnosis? The role of respiratory polygraphy management. Paper presented at: American College of Chest Physicians Annual International Scientific Assembly (CHEST); 2014 Mar 21; Madrid, Spain.
  4. Kuna ST. Evaluating OSA outside the lab. Paper presented at: Associated Professional Sleep Societies, LLC Annual Meeting; 2012 Jun 13; Boston, MA.
  5. Kuna ST. Ambulatory management of OSA: VA Health System. Paper presented at: American Thoracic Society Annual International Conference; 2012 May 22; San Francisco, CA.
  6. Kuna ST. Controversies in the diagnosis and management of obstructive sleep apnea: cutting-edge debates: pro: in laboratory polysomnography is on life support: the future of sleep medicine is home sleep studies. Paper presented at: American Thoracic Society Annual International Conference; 2012 May 21; San Francisco, CA.
  7. Parthasarathy S, Wendel C, Haynes PL, Atwood CW, Kuna ST. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. Paper presented at: American Thoracic Society Annual International Conference; 2012 May 21; San Francisco, CA.
  8. Kuna ST. Portable monitor testing: ready or not, here it comes. Paper presented at: Associated Professional Sleep Societies, LLC Annual Meet the Professor Sessions; 2011 Jun 3; Minneapolis, MN.
  9. Atwood CW. Home sleep apnea testing: the way forward. Paper presented at: American College of Chest Physicians Annual International Scientific Assembly (CHEST); 2010 Nov 4; Vancouver, Canada.
  10. Atwood CW. Update On Home Diagnosis and Therapy for OSA: Results From the Veterans Sleep Apnea Treatment Trial. Paper presented at: University of Pittsburgh Pulmonary Grand Rounds; 2010 Sep 24; Pittsburgh, PA.
  11. Kuna ST, Maislin G, Hin S, Hartwig KC, Hachadoorian R, Hurley S, Gupta R, Atwood CW. Non-inferiority of functional outcome in ambulatory management of obstructive sleep apnea. Paper presented at: American Thoracic Society Annual International Conference; 2010 May 19; New Orleans, LA.
  12. Atwood CW, Kuna ST. Home sleep apnea testing: state of the art. Presented at: National Association for Medical Direction of Respiratory Care Annual Meeting; 2010 May 18; San Diego, CA.
  13. Kuna ST. Home OSA testing in Veterans: results of the Veterans sleep apnea treatment trial. Paper presented at: American Thoracic Society Annual International Conference; 2010 May 14; New Orleans, LA.
  14. Kuna ST. Diagnosis and medical and positive pressure management of adult sleep disordered breathing. Paper presented at: Associated Professional Sleep Societies, LLC Annual Meeting; 2009 Jun 6; Seattle, WA.
  15. Atwood CW, Paul C, Fitzpatrick C, Hartwig KC. Re-assessment of long-term oxygen therapy after 6 weeks of use: a prospective evaluation. Paper presented at: American Thoracic Society Annual International Conference; 2007 May 18; San Francisco, CA.
  16. Kuna ST. Portable monitor sleep testing. Paper presented at: Associated Professional Sleep Societies, LLC Annual Meeting; 2006 Jun 1; Salt Lake City, UT.
  17. Kuna ST. New approaches to the diagnosis and treatment of sleep apnea. Paper presented at: American Academy of Sleep Medicine Annual Meeting; 2006 Feb 1; San Diego, CA.


DRA: Health Systems
DRE: Diagnosis
Keywords: Assessment, Cost effectiveness, Sleep disorders
MeSH Terms: none