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Noninvasive Positive Pressure Ventilation in the Home Technology Assessment Program Noninvasive Positive Pressure Ventilation in the Home Final Technology Assessment Project ID: PULT0717 2/4/2020 Technology Assessment Program Project ID: PULT0717 Noninvasive Positive Pressure Ventilation in the Home (with addendum) Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No: HHSA290201500013I_HHSA29032004T Prepared by: Mayo Clinic Evidence-based Practice Center Rochester, MN Investigators: Michael Wilson, M.D. Zhen Wang, Ph.D. Claudia C. Dobler, M.D., Ph.D Allison S. Morrow, B.A. Bradley Beuschel, B.S.P.H. Mouaz Alsawas, M.D., M.Sc. Raed Benkhadra, M.D. Mohamed Seisa, M.D. Aniket Mittal, M.D. Manuel Sanchez, M.D. Lubna Daraz, Ph.D Steven Holets, R.R.T. M. Hassan Murad, M.D., M.P.H. Key Messages Purpose of review To evaluate home noninvasive positive pressure ventilation (NIPPV) in adults with chronic respiratory failure in terms of initiation, continuation, effectiveness, adverse events, equipment parameters and required respiratory services. Devices evaluated were home mechanical ventilators (HMV), bi-level positive airway pressure (BPAP) devices, and continuous positive airway pressure (CPAP) devices. Key messages • In patients with COPD, home NIPPV as delivered by a BPAP device (compared to no device) was associated with lower mortality, intubations, hospital admissions, but no change in quality of life (low to moderate SOE). NIPPV as delivered by a HMV device (compared individually with BPAP, CPAP, or no device) was associated with fewer hospital admissions (low SOE). In patients with thoracic restrictive diseases, HMV (compared to no device) was associated with lower mortality (low SOE). In patients with neuromuscular diseases, home BPAP (compared to no device) was associated with lower mortality and better quality of life (low SOE). In patients with obesity hypoventilation syndrome, HMV/BPAP mix (compared to no device) was associated with lower mortality (low SOE). BPAP (compared to no device) was associated with improved sleep quality. • Current evidence is insufficient to assess the comparative effectiveness of many NIPPV device capabilities on patient outcomes; particularly comparing HMV to BPAP. Future studies should address which device capabilities are associated with improved patient outcomes. • Criteria to initiate home NIPPV and home respiratory services were summarized in this report but varied and were not validated in comparative studies. • Incidence of non-serious adverse events such as facial rash, dry eyes, mucosal dryness, and mask discomfort across devices was approximately 0.3 events over a median duration of device used of 6 months. The most commonly reported serious adverse event was acute respiratory failure. Based on direct comparisons, we found no statistically significant differences in number of treatment withdrawals or adverse events when comparing different devices or when comparing device use with no device use. iii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The Centers for Medicare & Medicaid Services requested this report from the EPC Program at AHRQ. AHRQ assigned this report to the following EPC: Mayo Clinic Evidence-based Practice Center (Contract Number: HHSA290201500013I_ HHSA29032004T). The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new health care technologies and strategies. They also identify research gaps in the selected scientific area, identify methodological and scientific weaknesses, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of the available literature. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review and public comment prior to their release as a final report. AHRQ expects that the EPC evidence reports and technology assessments, when appropriate, will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. If you have comments on this evidence report, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to [email protected] Gopal Khanna, M.B.A. Arlene Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Lionel L. Bañez, M.D. Director Task Order Officer Evidence-based Practice Center Program Center for Evidence and Practice Improvement Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Elise Berliner, PhD Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality iv A draft of this technology assessment was distributed solely for the purpose of public and peer review. This final report does not represent and should not be construed to represent an AHRQ determination or policy. This report is based on research conducted by the Mayo Clinic Evidence-based Practice Center (Contract Number: HHSA290201500013I_HHSA29032004T). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ and CMS. No statement in this article should be construed as an official position of AHRQ, CMS, or the U.S. Department of Health and Human Services. None of the investigators has any affiliations or financial involvement related to the material presented in this report. Persons using assistive technology may not be able to fully access information in this report. For assistance, contact [email protected]. Suggested citation: Wilson M, Wang Z, Dobler C, Morrow A, Beuschel B, Alsawas M, Benkhadra R, Seisa M, Mittal A, Sanchez M, Daraz L, Holets S, Murad MH. Noninvasive Positive Pressure Ventilation in the Home. Project ID: PULT0717 (Prepared by the Mayo Clinic Evidence-Based Practice Center under Contract No. HHSA290201500013I_HHSA29032004T). Rockville, MD: Agency for Healthcare Research and Quality. March 2019. http://www.ahrq.gov/ clinic/epcix.htm. v Acknowledgments The authors gratefully acknowledge the following individuals for their contributions to this project: from the Agency for Healthcare Research and Quality our task order officers, Lionel Bañez, M.D. and Elise Berliner, Ph.D., from Centers for Medicare and Medicaid Services Susan M. Miller, M.D and James Rollins, M.D. Key Informants In designing the study questions, the EPC consulted several Key Informants who represent the end-users of research. The EPC sought the Key Informant input on the priority areas for research and synthesis. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches, and/or conclusions do not necessarily represent the views of individual Key Informants. Key Informants must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any conflicts of interest. The list of Key Informants who provided input to this report follows: Key Informants Mark Calmes Sairam Parthasarathy, MD* ALS Association University of Arizona Decatur, IL Tucson, AZ Gerard Criner, MD Temple University Lora Reineck, MD Philadelphia, PA National Heart, Lung, and Blood Institute Bethesda, MD Marny Eulberg, MD Easter Seals Colorado Steven Ziegler Westminster, CO ALS Association St. Louis, MO Louis Libby, MD* The Oregon Clinic Portland, OR * This Key Informant also provided input on the draft report. vi Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers. Peer Reviewers must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential non-financial conflicts may be retained. The TOO and the EPC work to balance,
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