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Structured Abstract
Objective:
Update a 2011 review of differences in accuracy of diagnostic tests and the effects of interventions to prevent and treat Clostridium difficile infection (CDI) in adults.
Data sources:
Medline®, the Cochrane Clinical Trials Registry, and Embase® from 2010 through April 2015 plus reference lists of included studies and recent systematic reviews.
Methods:
Two investigators screened abstracts and full texts of identified references for eligibility. Eligible studies included studies of sensitivity and specificity for diagnostic tests in patients at risk for CDI. We included randomized controlled trials or high-quality cohort studies enrolling adult patients with CDI or suspected CDI for treatment interventions. Prevention studies also included adult patients at risk for CDI and observational study designs. Two investigators extracted data, assessed individual study risk of bias, and evaluated the strength of evidence for each comparison and outcome. Pooled estimates were analyzed to assess the efficacy and comparative effectiveness of a variety of treatments.
Results:
We identified 37 diagnostic studies and 56 studies evaluating prevention or treatment interventions to update the review. High-strength evidence showed that nucleic amplification tests were sensitive and specific for CDI when using culture as the reference standard. Low-strength evidence was found that some institutional prevention interventions, such as antibiotic prescribing practices and transmission interruption (terminal room cleaning with hydrogen peroxide vapor and handwashing campaigns), reduce CDI incidence. Low-strength evidence also suggested that prevention programs can be sustained over several years. For CDI treatment, vancomycin is more effective than metronidazole (high-strength evidence), and the effect does not vary by severity (moderate-strength evidence). Fidaxomicin remains noninferior to vancomycin for the initial cure of CDI (moderate-strength evidence) but is superior to vancomycin for prevention of recurrent CDI (now high-strength evidence). Although both fecal microbiota transplantation (FMT) and probiotics were the subject of a significant number of new studies, the overall high risk of bias of many of these studies necessitated ratings of low strength of evidence. Specifically, low-strength evidence suggests that FMT may have a significant effect on reducing recurrent CDI. Similarly, low-strength evidence suggests that lactobaccilus strains and multiorganism probiotics also can reduce recurrent CDI. However, Saccharomyces boulardii was no more effective than placebo in preventing recurrent CDI. Evidence for FMT for refractory CDI was insufficient. Few studies reported adverse events; when reported, few events were noted.
Conclusions:
Research on diagnostic testing for and interventions to treat CDI expanded considerably in 4 years. Nucleic acid amplification tests have high sensitivity and specificity for CDI. Vancomycin is more effective than metronidazole for initial CDI, while fidaxomicin is more effective than vancomycin for the prevention of recurrent CDI. FMT and lactobacillus probiotics to restore colonic biodiversity and improve patient resistance to CDI or recurrence have low-strength but relatively consistent positive evidence for efficacy.
Contents
- Preface
- Acknowledgments
- Technical Expert Panel
- Peer Reviewers
- Introduction
- Methods
- Results
- Literature Search Results
- KQ1 How do different methods for detection of toxigenic C. difficile to assist with diagnosis of CDI compare in their sensitivity, specificity, and predictive values?
- KQ2 What are effective prevention strategies?
- KQ3 What are the comparative effectiveness and harms of different antibiotic treatments?
- KQ4 What are the effectiveness and harms of other interventions?
- Discussion
- References
- Abbreviations
- Appendix A Analytic Frameworks
- Appendix B Search Strings
- Appendix C Excluded Studies
- Appendix D Risk-of-Bias Assessment Form for Observational Studies
- Appendix E Description and Characteristics of Included Studies
- Appendix F Risk of Bias and Study Quality
- Appendix G Detailed Analyses
- Appendix H Strength of Evidence
- Appendix I Ongoing Studies
- Appendix J References for Appendixes
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-00016-I. Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN
Suggested citation:
Butler M, Olson A, Drekonja D, Shaukat A, Schwehr N, Shippee N, Wilt TJ. Early Diagnosis, Prevention, and Treatment of Clostridium difficile: Update. Comparative Effectiveness Review No. 172. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00016-I.) AHRQ Publication No. 16-EHC012-EF. Rockville, MD: Agency for Healthcare Research and Quality; March 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00016-I). The findings and conclusions in this document are those of the authors, 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.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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.
AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
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.ahrq.gov
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