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Quality of Reporting in Systematic Reviews of Implantable Medical Devices
Methods Research Reports
Investigators: Gowri Raman, MD, MS, James M Gaylor, BA, Madhumathi Rao, MD, PhD, Jeffrey Chan, BS, Amy Earley, BS, Lina Kong Win Chang, BS, Priyanka Salvi, BDS, MPH, Jenny Lamont, MS, and Joseph Lau, MD.
Author Information and AffiliationsStructured Abstract
Background:
Despite a significant number of published systematic reviews of implantable medical devices, no empirical evaluation of the reviews has been performed. We conducted a critical appraisal of the quality of reporting in systematic reviews of implantable medical devices to understand the methodologies used; identify current strengths, limitations, deficiencies, and unique challenges; and make recommendations to improve future conduct and reporting.
Methods:
A Technical Expert Panel (TEP) of private and public payers, industry, and U.S. Food and Drug Administration representatives helped to refine the scope of the project, identified device categories, and provided feedback on the methodological approach. Five device categories were reviewed: cardiac implantable devices (e.g., defibrillators), vascular interventional devices (e.g., stents), orthopedic implants (e.g., prosthetic discs), skin-replacement grafts (e.g., wound care products), and neurostimulators (e.g., deep brain neurostimulators). Searches were conducted in MEDLINE® and the Cochrane Database of Systematic Reviews for systematic reviews published from January 2009 to December 2010. The search was repeated to cover January 2004 to January 2009 to identify additional eligible reviews for skin-replacement grafts and cardiac implantable devices. We addressed 30 items about quality of reporting in systematic reviews from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. With input from the TEP, we developed eight device- and procedure-specific items relevant to the evaluation of implantable medical devices.
Results:
Our searches yielded 467 citations, of which 181 met the eligibility criteria: 19 (10 percent) evaluated cardiac implantable devices, 124 (69 percent) evaluated vascular interventional devices, 16 (9 percent) evaluated orthopedic implants, 8 (4 percent) evaluated skin-replacement grafts, and 14 (8 percent) evaluated neurostimulators. Of the 181 systematic reviews included, 123 (68 percent) involved meta-analyses and the remaining 58 (32 percent) involved no meta-analyses; 66 (36 percent) reviewed randomized trials only, 51 (28 percent) reviewed nonrandomized studies only, 56 (31 percent) reviewed both, and 8 (4 percent) did not explicitly report the study designs included. Twenty of 30 PRISMA and MOOSE items we ascertained were commonly reported in greater than 50 percent of the reviews. Device-specific information was less commonly reported in reviews—differences in characteristics across devices (47 percent), differences in characteristics within a device (36 percent), and evolution of technology and its potential effects (21 percent). Operator-specific information was rarely reported in reviews—including training of providers (1 percent), ramp-up in provider technique or learning curve (7 percent), evaluation of team expertise (9 percent), practitioner variability (10 percent), and volume at each study site (8 percent).
Conclusion:
Our evaluation of 181 systematic reviews on implantable medical devices reveals a lack of reporting of some important generic items applicable to any systematic review as well as device- and operator-specific information. We identified eight device- or operator-specific items that might be of value in reporting on systematic reviews of implantable devices and could be incorporated into reporting guidelines.
Contents
- Preface
- Technical Expert Panel
- Peer Reviewers
- Background
- Methods
- Results
- Key Question 1 How are items such as literature searches, study selection, and results reported in published systematic reviews of implantable medical devices?
- Key Question 2 How do published systematic reviews of implantable medical devices report device- or operator-specific information?
- Key Question 3 How is the reporting of heterogeneity handled in published systematic reviews of implantable medical devices?
- Key Question 4 What are the limitations and issues related to reporting of quality and generalizability in published systematic reviews of implantable medical devices?
- Other Subgroup Analyses
- Discussion
- Conclusions
- References
- Appendix A Search Strategy
- Appendix B Data Extraction Form
- Appendix C List of Included Studies in the Analyses
- Appendix D Excluded Studies After Full-Text Screening
- Appendix E Tables 1–4 Subgroup Analyses
- Appendix F A Critical Appraisal of Primary Studies of Implantable Medical Devices
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10055-I. Prepared by: Tufts Evidence-based Practice Center, Boston, MA
Suggested citation:
Raman G, Gaylor JM, Rao M, Chan J, Earley A, Chang LKW, Salvi P, Lamont J, Lau J. Quality of Reporting in Systematic Reviews of Implantable Medical Devices. Methods Research Report. (Prepared by the Tufts Evidence-based Practice Center under Contract No. 290-2007-10055-I.) AHRQ Publication No. 12(13)-EHC116-EF. Rockville, MD. Agency for Healthcare Research and Quality; November 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Tufts Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10055-I). 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. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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.ahrq.gov
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