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Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium Difficile Infection Comparative Effectiveness Review Number 31

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Comparative Effectiveness Review Number 31 Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection Comparative Effectiveness Review Number 31 Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0009 (EPC2) Prepared by: Minnesota Evidence-based Practice Center Minneapolis, Minnesota Investigators: Mary Butler, Ph.D., M.B.A. Donna Bliss, R.N., Ph.D. Dimitri Drekonja, M.D. Gregory Filice, M.D. Thomas Rector, Pharm.D., Ph.D. Roderick MacDonald, M.S. Timothy Wilt, M.D., M.P.H. AHRQ Publication No. 11(12)-EHC051-EF December 2011 This report is based on research conducted by the Minnesota Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0009—EPC2). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. 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 clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment. This report may be used, in whole or in part, as the basis for the 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. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance, contact [email protected]. No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report. Suggested Citation: Butler M, Bliss D, Drekonja D, Filice G, Rector T, MacDonald R, Wilt T. Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection. Comparative Effectiveness Review No. 31 (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-02-0009.) AHRQ Publication No. 11(12)-EHC051-EF. Rockville, MD. Agency for Healthcare Research and Quality. December 2011. ii Preface The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services to meet the needs of Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). AHRQ has an established network of Evidence-based Practice Centers (EPCs) that produce Evidence Reports/Technology Assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care. The EPCs now lend their expertise to the Effective Health Care Program by conducting Comparative Effectiveness Reviews (CERs) of medications, devices, and other relevant interventions, including strategies for how these items and services can best be organized, managed, and delivered. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about systematic reviews, see http://effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that CERs will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. In addition, AHRQ is committed to presenting information in different formats so that consumers who make decisions about their own and their family’s health can benefit from the evidence. Transparency and stakeholder input are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an e-mail list to learn about new program products and opportunities for input. Comparative Effectiveness Reviews will be updated regularly. We welcome comments on this CER. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Shilpa Amin, M.D., MBsc, FAAFP Director, EPC Program Task Order Officer Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Robert Zuhlke Contracting Officer Agency for Healthcare Research and Quality iii Acknowledgments We sincerely thank all peer and public reviewers and David Samson for their comments and suggestions. The report is better because of their contributions. We would like to thank Christa Prodzinski, Maureen Carlyle, and especially Marilyn Eells, for editing support. We would also like to thank Michelle Brasure, Jim Tacklind, and Indy Rutks, for their librarian expertise, database management, abstracting skills, and all-around general support. iv Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection Structured Abstract Objectives. To conduct a systematic review and synthesize evidence for differences in the accuracy of diagnostic tests, and the effects of interventions to prevent and treat Clostridium difficile infection (CDI) in adult patients. Data Sources. Searching for relevant literature was conducted in MEDLINE, the Cochrane Library, and Allied and Complementary Medicine (AMED). ClinicalTrials.gov and expert consultants provided leads to additional studies. We also manually searched reference lists from relevant literature. Review Methods. Standard Evidence-based Practice Center methods were employed. Screening of abstracts and full text articles to identify studies meeting inclusion/exclusion criteria was performed by two independent reviewers. High-quality direct comparison studies were used to examine differences in diagnostic tests. Randomized controlled trials (RCTs) were used to examine comparative effectiveness of antibiotic treatment for CDI. Quality of data extraction was checked by separate reviewers. Quality ratings and strength of evidence grading was performed on included studies. Evidence on diagnostic tests was quantitatively synthesized focusing on differences between test sensitivities and specificities. Evidence on antibiotic treatment was quantitatively examined using pooled analysis. Qualitative narrative analysis was used to synthesize evidence from all available study types for environmental prevention and nonstandard prevention and treatment, with the exception of probiotics as primary prevention, for which a forest plot is provided. Results. Overall, literature was sparse and strength of evidence was generally low due to small sample sizes or lack of adequate controls. For diagnostic testing, direct comparisons of commercially available enzyme immunoassays for C. difficile toxins A and B did not find major differences in sensitivity or specificity. Limited evidence suggests that tests for genes related to the production of C. difficile toxins may be more sensitive than immunoassays for toxins A and B while the comparisons of these test specificities were inconsistent. Moderate evidence in favor of antibiotic restriction policies for prevention was found. Environmental preventive interventions such as glove use and disposable thermometers have limited evidence. However, this literature is largely based on controlling outbreaks. Use of multiple component interventions further limits the ability to synthesize evidence in a meaningful way. Numerous potential new forms of treatment are being examined in placebo controlled RCTs, case series, and case reports. For standard treatment, no antimicrobial is clearly superior for the initial cure of CDI. Recurrence is less frequent with fidaxomicin than with vancomycin. Monoclonal antibodies for prevention and fecal flora reconstitution for multiple recurrences appear promising. v Conclusions. Given the frequency and severity of CDI and the fact that future reimbursement policy may withhold payment for hospital-acquired infections, this
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