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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from Treatment of stable chronic obstructive pulmonary disease: a protocol for a systematic review and evidence map Journal: BMJ Open ManuscriptFor ID peerbmjopen-2018-027935 review only Article Type: Protocol Date Submitted by the 15-Nov-2018 Author: Complete List of Authors: Dobler, Claudia; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Farah, Magdoleen; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Morrow, Allison; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery alsawas, mouaz; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Benkhadra, Raed; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Hasan, Bashar; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Prokop, Larry; Mayo Clinic, Library Public Services http://bmjopen.bmj.com/ Wang, Zhen; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Murad, M. Hassan; Mayo Clinic, Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Chronic obstructive pulmonary disease, pharmacological interventions, Keywords: non-pharmacological interventions, umbrella review, evidence map, knowledge translation on September 26, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 43 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from 1 2 3 Treatment of stable chronic obstructive pulmonary disease: a protocol for a 4 5 6 systematic review and evidence map 7 8 9 1 1 1 1 1 10 Claudia C. Dobler, Magdoleen H Farah, Allison S. Morrow, Mouaz Alsawas, Raed Benkhadra Bashar 11 1 2 1 1 12 Hasan, Larry J Prokop, Zhen Wang, M. Hassan Murad 13 14 15 1) Evidence-Based Practice Center, Robert D. and Patricia E. Kern Center for the Science of Health 16 For peer review only 17 Care Delivery, Mayo Clinic, Rochester, Minnesota, USA 18 19 2) Library Public Services, Mayo Clinic, Rochester, Minnesota, USA. 20 21 22 23 24 25 26 27 28 29 Correspondence to 30 31 Dr. Claudia C Dobler 32 http://bmjopen.bmj.com/ 33 Evidence-based Practice Center 34 35 Mayo Clinic 36 Rochester MN 55905 37 38 USA 39 40 [email protected] on September 26, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 1 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 43 BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from 1 2 3 Abstract 4 5 Introduction: Chronic obstructive pulmonary (COPD) disease is a progressive lung disease, usually 6 7 caused by tobacco smoking, but other important risk factors include exposures to combustion products of 8 9 biomass fuels and environmental pollution. The introduction of several new (combination) inhaler 10 11 therapies, increasing uncertainty about the role of inhaled corticosteroids and a rapid proliferation of the 12 13 literature on management of stable COPD in general, call for novel ways of evidence synthesis in this 14 15 area. A systematic review and evidence map can provide the basis for shared decision-making tools and 16 For peer review only 17 help establish a future research agenda. 18 19 Methods and analysis: This systematic review will follow an umbrella systematic review design (also 20 21 called overview of reviews). We plan to conduct a comprehensive literature search of six databases. We 22 23 will include systematic reviews that assessed the effectiveness of any pharmacological or non- 24 25 pharmacological intervention on one or more patient-important outcomes and/or lung function in patients 26 with stable COPD. For every intervention/outcome pair one systematic review will be included. An a priori 27 28 protocol will guide which systematic reviews will be chosen, how their credibility will be evaluated, and 29 30 how the quality of the body of evidence will be rated. Data will be synthesized into an evidence map that 31 32 will present a matrix that depicts each available treatment for stable COPD with a quantitative estimate on http://bmjopen.bmj.com/ 33 34 symptoms/outcomes from the patient perspective, along with an indication of the size and certainty in the 35 36 evidence. 37 38 Ethics and dissemination: Approval by a research ethics committee is not required since the review will 39 40 only include published and publicly accessible data. The systematic review will be published in a peer- on September 26, 2021 by guest. Protected copyright. 41 42 reviewed journal and will provide various stakeholders with an evidence map. 43 44 Systematic review registration: PROSPERO registration number CRD42018095079 45 46 47 48 Keywords 49 Chronic obstructive pulmonary disease, pharmacological interventions, non-pharmacological 50 51 interventions, umbrella review, evidence map, knowledge translation, decision aid 52 53 54 55 56 57 58 2 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 43 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from 1 2 3 Article Summary 4 5 Strengths and limitations of this study 6 7 The planned evidence synthesis will summarise a very large body of literature on 8 9 pharmacological and non-pharmacological interventions thus making research evidence more 10 11 accessible for stakeholders 12 13 The systematic review will be the first to use an evidence map to identify evidence gaps and to 14 15 facilitate evidence communication in clinical encounters for COPD. 16 For peer review only 17 For patients and clinicians, the map will facilitate the production of decision aids. For 18 19 policymakers and researchers, the map helps in establishing a future research agenda. 20 21 The systematic review uses an a priori protocol to identify the most up-to-date systematic reviews 22 23 of the highest possible quality, and the level of evidence for many intervention/outcome pairs will 24 25 therefore likely be high 26 27 As we will only include one systematic review per intervention/outcome pair, it is possible that 28 29 some studies will not have been captured in included systematic reviews 30 31 32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39 40 on September 26, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 3 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 43 BMJ Open: first published as 10.1136/bmjopen-2018-027935 on 5 May 2019. Downloaded from 1 2 3 Introduction 4 5 6 Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by chronic 7 8 obstruction of airflow and permanent damage to the air sacs that leads to breathing problems. COPD is 9 10 mainly a consequence of tobacco smoking, but other important risk factors include exposures to 11 12 combustion products of biomass fuels and environmental pollution.1 COPD is the fourth most common 13 14 cause of death globally and is predicted to be the third by 2030.2 In 2010, the number of COPD cases 15 16 was estimated at 384For million, which peer corresponded review to a global prevalence only of 11.7% (95% confidence 17 18 interval [CI] 8.4%–15.0%).2 COPD was responsible for about 5% of global disability–adjusted life years 19 20 (76.7 million) and 5% of total deaths (2.9 million) based on data from the 2010 Global Burden of Disease 21 3 4 22 study. In some low- and middle income countries COPD has become a growing, but often neglected, 23 epidemic, with a recent study showing a prevalence of COPD of 13.7% (95% CI 12.1–15.5) in Chinese 24 25 people aged 40 years or older.5 Patients with COPD are frequent users of the health care system and 26 27 often need to be admitted to hospital repeatedly, often within short intervals.6 28 29 30 31 Recently, there has been a rapid increase in inhaler therapies available for the management of COPD.
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