Shahnaz Sultan

American Gastroenterological Association Institute Guideline on the Management of Crohn's Disease After Surgical Resection.

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American Gastroenterological Association Institute Technical Review on the Management of Crohn’s Disease After Surgical Resection

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Methodological quality and synthesis of case series and case reports

Case reports and case series are uncontrolled study designs known for increased risk of bias but have profoundly influenced the medical literature and continue to advance our knowledge. In this guide, we present a framework for appraisal, synthesis and application of evidence derived from case reports and case series. We propose a tool to evaluate the methodological quality of case reports and case series based on the domains of selection, ascertainment, causality and reporting and provide signalling questions to aid evidence-based practitioners and systematic reviewers in their assessment. We suggest using evidence derived from case reports and case series to inform decision-making when no other higher level of evidence is available.

Rating the certainty in evidence in the absence of a single estimate of effect

When studies measure or report outcomes differently, it may not be feasible to pool data across studies to generate a single effect estimate (ie, perform meta-analysis). Instead, only a narrative summary of the effect across different studies might be available. Regardless of whether a single pooled effect estimate is generated or whether data are summarised narratively, decision makers need to know the certainty in the evidence in order to make informed decisions. In this guide, we illustrate how to apply the constructs of the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) approach to assess the certainty in evidence when a meta-analysis has not been performed and data were summarised narratively.

Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM): Rationale for Study Design

Rationale:Colorectal cancer (CRC) is preventable through screening, with colonoscopy and fecal occult blood testing comprising the two most commonly used screening tests. Given the differences in complexity, risk, and cost, it is important to understand these tests’ comparative effectiveness.Study design:The CONFIRM Study is a large, pragmatic, multicenter, randomized, parallel group trial to compare screening with colonoscopy vs. the annual fecal immunochemical test (FIT) in 50,000 average risk individuals. CONFIRM examines whether screening colonoscopy will be superior to a FIT-based screening program in the prevention of CRC mortality measured over 10 years. Eligible individuals 50–75 years of age and due for CRC screening are recruited from 46 Veterans Affairs (VA) medical centers. Participants are randomized to either colonoscopy or annual FIT. Results of colonoscopy are managed as per usual care and study participants are assessed for complications. Participants testing FIT positive are referred for colonoscopy. Participants are surveyed annually to determine if they have undergone colonoscopy or been diagnosed with CRC. The primary endpoint is CRC mortality. The secondary endpoints are (1) CRC incidence (2) complications of screening colonoscopy, and (3) the association between colonoscopists’ characteristics and neoplasia detection, complications and post-colonoscopy CRC. CONFIRM leverages several key characteristics of the VA’s integrated healthcare system, including a shared medical record with national databases, electronic CRC screening reminders, and a robust national research infrastructure with experience in conducting large-scale clinical trials. When completed, CONFIRM will be the largest intervention trial conducted within the VA (ClinicalTrials.gov identifier: NCT01239082).

Stakeholders apply the GRADE evidence-to-decision framework to facilitate coverage decisions

OBJECTIVES Coverage decisions are complex and require the consideration of many factors. A well-defined, transparent process could improve decision-making and facilitate decision-maker accountability. STUDY DESIGN AND SETTING We surveyed key US-based stakeholders regarding their current approaches for coverage decisions. Then, we held a workshop to test an evidence-to-decision (EtD) framework for coverage based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. RESULTS A total of 42 individuals (including 19 US stakeholders as well as international health policymakers and GRADE working group members) attended the workshop. Of the 19 stakeholders, 14 (74%) completed the survey before the workshop. Almost all of their organizations (13 of 14; 93%) used systematic reviews for coverage decision-making; few (2 of 14; 14%) developed their own evidence synthesis; a majority (9 of 14; 64%) rated the certainty of evidence (using various systems); almost all (13 of 14; 93%) denied formal consideration of resource use; and half (7 of 14; 50%) reported explicit criteria for decision-making. At the workshop, stakeholders successfully applied the EtD framework to four case studies and provided narrative feedback, which centered on contextual factors affecting coverage decisions in the United States, the need for reliable data on subgroups of patients, and the challenge of decision-making without formal consideration of resource use. CONCLUSION Stakeholders successfully applied the EtD framework to four case studies and highlighted contextual factors affecting coverage decisions and affirmed its value. Their input informed the further development of a revised EtD framework, now publicly available (http://gradepro.org/).

Efficacy of Treatments for Opioid-Induced Constipation: Systematic Review and Meta-analysis

Background & Aims Opioid‐induced constipation (OIC) is a common problem in patients on chronic opioid therapy for cancer‐related and non–cancer‐related pain. Approved treatments for OIC are methylnaltrexone, naloxone, naloxegol, alvimopan, naldemedine, and lubiprostone. Since a meta‐analysis performed in 2014, 2 new agents have been approved by the Food and Drug Administration for treatment of OIC (naloxegol and naldemedine). Methods We conducted a search of the medical literature following the protocol outlined in the Cochrane Handbook for systematic review. We searched MEDLINE, EMBASE, EMBASE Classic, Web of Science, and the Cochrane Central Register of Controlled Trials until March 2017 to identify randomized controlled trials of peripheral &mgr;‐opioid–receptor antagonists (methylnaltrexone, naloxone, naloxegol, alvimopan, axelopran, or naldemedine), lubiprostone, or prucalopride. Response to therapy was extracted in a dichotomous assessment as an overall response to therapy. The effect of pharmacologic therapies was pooled and reported as a relative risk (RR) of failure to respond to the treatment drug, with 95% CIs. Results We included 27 placebo‐controlled trials in our meta‐analysis (23 trials evaluated &mgr;‐opioid–receptor antagonists, 3 trials evaluated lubiprostone, and 1 trial evaluated prucalopride). In these trials, 5390 patients received a drug and 3491 received a placebo. Overall, &mgr;‐opioid–receptor antagonists, lubiprostone, and prucalopride were superior to placebo for the treatment of OIC, with a RR of failure to respond to therapy of 0.70 (95% CI, 0.64–0.75) and an overall number needed to treat of 5 (95% CI, 4–7). When restricted to only Food and Drug Administration–approved medications for OIC, the RR of failure to respond to therapy was 0.69 (95% CI, 0.62‐0.77), with a number needed to treat of 5 (95% CI, 4–7). Sensitivity analyses and meta‐regression performed to account for heterogeneity showed that treatment was more likely to be effective in study populations taking higher doses of opiates at baseline or refractory to laxatives. Study duration and prespecified primary outcome did not affect the RR of failure. Participants who received &mgr;‐opioid–receptor antagonists were significantly more likely to have diarrhea, abdominal pain, nausea, or vomiting than patients who received placebo. Conclusions In a systematic review and meta‐analysis, we found &mgr;‐opioid–receptor antagonists to be safe and effective for the treatment of OIC. Prescription‐strength laxatives (prucalopride, lubiprostone) are slightly better than placebo in reducing OIC.

What does expert opinion in guidelines mean? a meta-epidemiological study

Guidelines often use the term expert opinion (EO) to qualify recommendations. We sought to identify the rationale and evidence type in EO recommendations. We searched multiple databases and websites for contemporary guidelines published in the last decade that used the term EO. We identified 1106 references, of which 69 guidelines were included (2390 recommendations, of which 907 were qualified as EO). A rationale for using EO designation was not provided in most (91%) recommendations. The most commonly cited evidence type was extrapolated from studies that did not answer guideline question (40% from randomised trials, 38% from observational studies and 2% from case reports or series). Evidence extrapolated from populations that were different from those addressed in the guideline was found in 2.5% of EO recommendations. We judged 5.6% of EO recommendations as ones that could have been potentially labelled as good practice statements. None of the EO recommendations were explicitly described as being solely dependent on the clinical experience of the panel. The use of EO as a level of evidence in guidelines remains common. A rationale for such use is not explicitly provided in most instances. Most of the time, evidence labelled as EO was indirect evidence and occasionally was very low-quality evidence derived from case series. We posit that the explicit description of evidence type, as opposed to using the label EO, may add clarity and transparency and may ultimately improve uptake of recommendations.

Contribution of patient, physician, and environmental factors to demographic and health variation in colonoscopy follow‐up for abnormal colorectal cancer screening test results

Patient, physician, and environmental factors were identified, and the authors examined the contribution of these factors to demographic and health variation in colonoscopy follow‐up after a positive fecal occult blood test/fecal immunochemical test (FOBT/FIT) screening.

Continuing Medical Education Questions: June 2018

2. A 52-year-old male with AIDS is admitted to the hospital with more than 3 months of watery diarrhea. The patient had been diagnosed with HIV infection 3 years prior to admission but had been non-compliant with antiviral therapy. His most recent CD4 count was <100 copies/mL. The patient reported >15 watery stools per day associated with anorexia, right upper quadrant abdominal pain, and weight loss. A single microscopic examination of stool for ova and protozoal parasites was negative. Laboratory tests indicated an elevated GGT and alkaline phosphatase. Which of the following best explains this patient’s current symptoms?