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Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection [Entered Retrospectively]

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Statistics: 112 Studies, 10 Key Questions, 10 Extraction Forms,
Date Published: Jul 23, 2015 02:29PM
Description: 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). 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. Conclusions: Given the frequency and severity of CDI and the fact that future reimbursement policy may withhold payment for hospital-acquired infections, this is an under-researched topic. More precise estimates of the magnitude of differences in test sensitivities and specificities are needed. More importantly, studies have not established that any of the possible differences in test accuracy would lead to substantially different patient outcomes in clinical practice. More research on effective treatment and unintended consequences of treatment, such as resistance, is needed. Gut flora may be important, but improved understanding of healthy gut ecology and the complex interactions is necessary before continuing to pursue probiotics.
Contributor(s): Mary Butler, PhD, MBA; Donna Bliss, RN, PhD; Dimitri Drekonja, MD; Gregory Filice, MD; Thomas Rector, PharmD, PhD; Roderick MacDonald, MS; Timothy Wilt, MD, MPH
Funding Source: The Agency for Healthcare Research and Quality (AHRQ)
Methodology Description: None Provided

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Benefits and Harms of Routine Preoperative Testing: Comparative Effectiveness Review 2013

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Statistics: 220 Studies, 4 Key Questions, 4 Extraction Forms,
Date Published: Jul 23, 2015 02:19PM
Description: Objectives: Preoperative testing is used to guide the action plan for patients undergoing surgical and other procedures that require anesthesia and to predict potential postoperative complications. There is uncertainty whether routine or per-protocol testing in the absence of a specific indication prevents complications and improves outcomes, or whether it causes unnecessary delays, costs, and harms due to false-positive results. Data sources: We searched MEDLINE® and Ovid Healthstar® (from inception to July 22, 2013), as well as Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews. Review methods: We included comparative and cohort studies of both adults and children undergoing surgical and other procedures requiring either anesthesia or sedation (excluding local anesthesia). We included all preoperative tests that were likely to be conducted routinely (in all patients) or on a per-protocol basis (in selected patients). For comparative studies, the comparator of interest was either no testing or ad hoc testing done at the discretion of the clinician. We also looked for studies that compared routine and per-protocol testing. The outcomes of interest were mortality, perioperative events, complications, patient satisfaction, resource utilization, and harms related to testing. Results: Fifty-seven studies (14 comparative and 43 cohort) met inclusion criteria for the review. Well-conducted randomized controlled trials (RCTs) of cataract surgeries suggested that routine testing with electrocardiography, complete blood count, and/or a basic metabolic panel did not affect procedure cancellations (2 RCTs, relative risks [RRs] of 1.00 or 0.97), and there was no clinically important difference for total complications (3 RCTs, RR = 0.99; 95% confidence interval, 0.86 to 1.14). Two RCTs and six nonrandomized comparative studies of general elective surgeries in adults varied greatly in the surgeries and patients included, along with the routine or per-protocol tests used. They also mostly had high risk of bias due to lack of adjustment for patient and clinician factors, making their results unreliable. Therefore, they yielded insufficient evidence regarding the effect of routine or per-protocol testing on complications and other outcomes. There was also insufficient evidence for patients undergoing other procedures. No studies reported on quality of life, patient satisfaction, or harms related to testing. Conclusions: There is high strength of evidence that, for patients scheduled for cataract surgery, routine preoperative testing has no effect on total perioperative complications or procedure cancellation. There is insufficient evidence for all other procedures and insufficient evidence comparing routine and per-protocol testing. There is no evidence regarding quality of life or satisfaction, resource utilization, or harms of testing and no evidence regarding other factors that may affect the balance of benefits and harms. The findings of the cataract surgery studies are not reliably applicable to other patients undergoing other higher risk procedures. Except arguably for cataract surgery, numerous future adequately powered RCTs or well-conducted and analyzed observational comparative studies are needed to evaluate the benefits and harms of routine preoperative testing in specific groups of patients with different risk factors for surgical and anesthetic complications undergoing specific types of procedures and types of anesthesia.
Contributor(s): Ethan M Balk, MD, MPH; Amy Earley, BS; Nira Hadar, MS; Nirav Shah, MD; Thomas A Trikalinos, MD, PhD
Funding Source: National Eye Institute; National Institutes of Health (NIH); the Agency for Health Research and Quality (AHRQ).
Methodology Description: We conducted literature searches of studies in MEDLINE® and Ovid Healthstar® (inception – 22 July 2013), as well as the Cochrane Central Trials Registry® and Cochrane Database of Systematic Reviews® (through 2nd Quarter, 2013). The reference lists of prior systematic reviews and relevant guidelines were hand-searched. All citations were screened to identify articles relevant to each Key Question. The search included terms for surgical procedures, preoperative care, diagnostic tests, including the specific tests ECG, chest radiography, blood counts, coagulation tests, biochemistry, glucose, urinalysis, kidney function tests, liver function tests, pregnancy tests, hemoglobinopathies, and pulmonary function tests (see Appendix A for complete search strings). The EPC has developed a computerized screening program, Abstrackr, to automate the screening of abstracts for eligible articles for full-text screening ( Three team members double-screened all abstracts after an iterative training period to ensure that all screeners agreed upon the eligibility criteria. Abstrackr allowed us to label each citation as "accept," "reject," or "maybe." All abstracts with disagreements between readers or labeled as "maybe" were reconciled by the whole team in conference. Full-text articles were retrieved for all potentially relevant articles. These were rescreened for eligibility. All rejected articles were confirmed by the team leader. The reasons for excluding these articles are tabulated in Appendix B. Study eligibility was based on the following selection criteria: population and surgical procedure of interest, interventions (i.e., tests) and comparators of interest, outcomes of interest, and study designs. We did not consider outcomes when conducting abstract screening.

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