Fecal immunochemical testing (FIT) screens for colorectal cancer (CRC) through detection of hemoglobin. Specimens without a collection date are a common source of test cancellation. We implemented a quality improvement intervention to improve collection date documentation and screening completion using a pre-post design. Within a large US Veterans Affairs (VA) CRC screening trial, we modified the FIT return envelope instructions, including a field for collection date documentation on the envelope. Preintervention 6654/7083 FIT kits (93.9%) were received with a collection date compared to 3069/3105 (98.8%) postintervention (p < .00001). Preintervention, 35.2% of kits without a date were received within 15 days of original outbound mailing of the kit from VA, thereby allowing testing in 95.4% of all kits received. Postintervention, 44.4% of undated kits were received within 15 days of mailing from the VA, allowing for testing of 98.8% of all kits (p < .00001 compared to preintervention). The intervention was associated with an absolute 3.5% (95% CI: 2.8%-4.1%) increase in testable kits, thereby reducing the proportion of individuals requiring retesting from 4.6% to 1.2%. This no-cost, targeted intervention was associated with a significantly increased proportion of individuals successfully completing screening. Programs using FIT should consider implementation of this no-cost intervention to enhance program effectiveness.
Background: Effectively managing acute postoperative pain after laparoscopic surgery (M-PALS) is essential to optimize outcomes, enhance recovery, and mitigate opioid-related risks. We aimed to systematically map evidence on effectiveness and harms of pharmacologic and non-pharmacologic interventions for M-PALS. Methods: We searched three databases (2012-2025) for randomized clinical trials (RCTs) that reported postoperative opioid use and pain-related outcomes. We assessed study quality using the Cochrane Risk of Bias (ROB)-2 tool. Results: From 7638 citations, we included 101 RCTs. Postoperative opioid use was reported variably (e.g., total use over 24 or 48 h postoperatively, frequency of rescue-opioid use, and time to first rescue-opioid use). One out of 101 RCTs evaluated opioid prescription at discharge. No RCT reported opioid use at ≥3 months postoperatively. Eleven strategies were evaluated in ≥2 RCTs, with usual care/ sham as comparators. None of the 101 RCTs favored usual care over any intervention for pain or opioid use outcomes. For regional anesthesia (21 RCTs total; 12 with low ROB), intraperitoneal/preperitoneal local anesthetic instillation (10 RCTs; 4 with low ROB), intravenous dexamethasone (3 RCTs; 1 with low ROB), and the Enhanced Recovery After Surgery (ERAS) protocol (3 RCTs; 0 with low ROB), compared to usual care, >50% of RCTs favored the intervention for reducing pain and opioid use. For adverse events, only 3 out of 101 RCTs favored comparators. Inconsistent outcome reporting across all RCTs and, for multimodal strategies, the uniqueness of intervention-comparator combinations hindered comparisons. Conclusions: Interventions for M-PALS appear safe, with no RCT indicating worse efficacy of intervention than usual care; but evidence regarding superiority is conflicting. Future research should establish standardized and longer-term core outcome sets and make head-to-head comparisons between optimal strategies.
OBJECTIVES:We aimed to determine whether the existing risk of bias assessment tools addressed constructs other than risk of bias or internal validity and whether they used numerical scores to express quality, which is discouraged and may be a misleading approach. METHODS:We searched Ovid MEDLINE and Embase to identify quality appraisal tools across all disciplines in human health research. Tools designed specifically to evaluate reporting quality were excluded. Potentially eligible tools were screened by independent pairs of reviewers. We categorized tools according to conceptual constructs and evaluated their scoring methods. RESULTS:We included 230 tools published from 1995 to 2023. Access to the tool was limited to a peer-reviewed journal article in 63% of the sample. Most tools (76%) provided signaling questions, whereas 39% produced an overall judgment across multiple domains. Most tools (93%) addressed concepts other than risk of bias, such as the appropriateness of statistical analysis (65%), reporting quality (64%), indirectness (41%), imprecision (38%), and ethical considerations and funding (22%). Numerical scoring was used in 25% of tools. CONCLUSION:Currently available study quality assessment tools were not explicit about the constructs addressed by their items or signaling questions and addressed multiple constructs in addition to risk of bias. Many tools used numerical scoring systems, which can be misleading. Limitations of the existing tools make the process of rating the certainty of evidence more difficult. PLAIN LANGUAGE SUMMARY:Many tools have been made to assess how well a scientific study was designed, conducted, and written. We searched for these tools to better understand the types of questions they ask and the types of studies to which they apply. We found 230 tools published between 1995 and 2023. One in every four tools used a numerical scoring system. This approach is not recommended because it does not distinguish well between different ways quality can be assessed. Tools assessed quality in a number of different ways, with the most common ways being risk of bias (how a study is designed and run to reduce biased results; 98%), statistical analysis (how the data were analyzed; 65%), and reporting quality (whether important details were included in the article; 64%). People who make tools in the future should carefully consider the aspects of quality that they want the tool to address and distinguish between questions of study design, conduct, analysis, ethics, and reporting.
Background and Aims: Colonoscopy is the gold standard screening modality for colorectal cancer; however, it is operator-dependent and reliant on exam quality. Incorporating artificial intelligence (AI) into colonoscopy may improve adenoma detection and clinical outcomes, but this is a sociotechnical challenge that requires effective human–AI teaming incorporating provider attitudes. Methods: We conducted a systematic review of studies evaluating attitudes and perspectives of providers toward AI-assisted colonoscopy. Participant responses to outcome questions of interest were combined across the studies to calculate pooled proportion (Pp) and 95% confidence interval (CI). Top-ranked perceived advantages and disadvantages in each study were defined as the items that >50% of the study participants voted for. Results: Out of 2044 abstracts screened, 13 studies were included representing 1538 providers who were mostly gastroenterologists or trainees and 25%–100% had direct experience using AI in a clinical setting. Overall, a large majority were interested in using AI (Pp = 80%, 95% CI 70%–89%, n = 8 studies) and believed it can improve adenoma or polyp detection rate (Pp = 74%, 95% CI 68%–80%, n = 4 studies). Among 5 studies addressing financial implications, about half were concerned about the cost of using AI (52%, 95% CI 24%–79%). An average of 38% of respondents (95% CI 9%–73%) from 4 studies raised concern regarding accountability for misdiagnosis. High number of false positives and an absence of clinical guidelines were top-ranked perceived disadvantages in 2 studies. Conclusion: Most gastroenterology providers expressed interest in using AI systems with colonoscopy and believed it can improve adenoma detection rate. Cost, high number of false positives, and lack of professional society guidelines were among top perceived concerns.
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder, with a prevalence of 4% to 10%. It is a chronic condition characterized by abdominal pain in conjunction with altered bowel habits, abdominal distention, or bloating. IBS can present with 3 different defecation patterns: IBS with constipation, IBS with diarrhea, or mixed IBS. Recent advances in IBS include a positive diagnosis based on symptom-based criteria and a treatment plan based on IBS subtype and bothersome symptoms. In addition to diet and lifestyle modifications, this article discusses the role of new pharmacologic and nonpharmacologic treatment options for the management of IBS.
Introduction:While certainty of evidence assessment is key to a rigorous and transparent systematic review, it is unknown how - and how frequently - it is assessed in systematic reviews. The objective of this study was to examine the prevalence and approaches used for certainty of evidence assessment in systematic reviews published in high-impact medicine journals over the past 11 years. Methods:A PubMed search and hand-searching of relevant journal websites identified systematic reviews published between 24 January 2013 and 23 January 2024 in any of the ten highest-impact journals in the General and Internal Medicine category of the Journal Citation Report. Two reviewers independently selected any systematic review related to health outcomes assessing certainty of evidence using any method. We extracted data related to review characteristics, certainty of evidence and risk of bias/methodological quality assessment frameworks, and reported consideration of certainty of evidence domains. Logistic regression examined year of publication to determine whether the prevalence of certainty of evidence assessment changed over time. Results:Of 1,023 included reviews, 346 (33.8%) assessed certainty of evidence. Prevalence of certainty of evidence assessment increased over time (0.16 ± 0.2; p < .001). Most (89.3%) of reviews used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to assess certainty of evidence. Conclusion:Only one in three systematic reviews published in the highest-impact medical journals over the past 11 years assessed certainty of evidence, though prevalence increased over time. The use of specific domains within each certainty of evidence framework was not clearly described in all reviews.
BackgroundGastrointestinal (GI) complications are the second most common disorders in persons with cystic fibrosis (PwCF). There is limited data on how having a dedicated CF-GI clinic and cystic fibrosis transmembrane conductance regulator (CFTR) modulators may affect rates of GI complications. Our aim was to assess the effect of the CF-GI clinic and CFTR modulators on GI complications with incidence of distal intestinal obstructive syndrome (DIOS).MethodsThis was a retrospective study of adult PwCF who were seen in a CF-GI clinic from 2000-2023. Comparisons were made between the numbers of admissions and emergency department (ED) visits for DIOS at three years before and after CFTR modulator use and the first CF-GI clinic visit.ResultsOf the 1,076 PwCF identified, 242 were seen in CF-GI clinic. Of this, 126 (52.1%) were female, with a median age of 40 (IQR: 30-47) years. There were 146 (60.3%) with regular use of laxatives. Of the 59 PwCF with CF-GI clinic visits for constipation, hospital admissions decreased in 16, were unchanged in 32, and increased in 11 (p = 0.402) while ED visits decreased in 9, remained the same in 40, and increased in 10 (p = 0.862). Of the 125 PwCF with CFTR modulator use, DIOS-related hospital admissions decreased in 15 patients, remained unchanged in 89, and increased in 21 (p = 0.021) while ED visits were fewer in 8, unchanged in 97, and increased in 20 (p = 0.587).ConclusionPwCF had high burden of constipation with a majority of patients regularly using laxatives, and almost half had a history of DIOS. CFTR modulator use and CF-GI clinic were not associated with a decrease of DIOS incidence.
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder, with a prevalence of 4% to 10%. It is a chronic condition characterized by abdominal pain in conjunction with altered bowel habits, abdominal distention, or bloating. IBS can present with 3 different defecation patterns: IBS with constipation, IBS with diarrhea, or mixed IBS. Recent advances in IBS include a positive diagnosis based on symptom-based criteria and a treatment plan based on IBS subtype and bothersome symptoms. In addition to diet and lifestyle modifications, this article discusses the role of new pharmacologic and nonpharmacologic treatment options for the management of IBS.
Objective To review the evidence and provide updated and new recommendations for the pharmacologic management of adults with dyslipidemia to prevent adverse cardiovascular outcomes. These recommendations are intended for use by clinicians, health care team members, patients, caregivers, and other stakeholders. Methods This guideline was developed by a multidisciplinary task force of content experts and guideline methodologists based on systematic reviews of randomized controlled trials or cohort studies from database inception to November 7, 2023. An updated literature search was completed for any additional articles published by May 31, 2024. Clinical questions addressing nonstatin medications and patient-important outcomes were prioritized. The task force assessed the certainty of the evidence and developed recommendations using the Grading of Recommendations Assessment, Development, and Evaluation framework. All recommendations were based on the consideration of the certainty of the evidence across patient-important outcomes, in addition to issues of feasibility, acceptability, equity, and patient preferences and values. Results This guideline update includes 13 evidence-based recommendations for the pharmacologic management of adults with dyslipidemia focused on patient-important outcomes of atherosclerotic cardiovascular disease (ASCVD) risk reduction. The task force issued a good practice statement to assess the risk of ASCVD events for primary prevention in adults with dyslipidemia. The task force suggested the use of alirocumab, evolocumab, or bempedoic acid for adults who have ASCVD or who are at increased risk for ASCVD in addition to standard care. The task force suggested against the use of these medications in adults without ASCVD. There was insufficient evidence to recommend for or against the addition of inclisiran. For adults with hypertriglyceridemia and ASCVD or increased risk of ASCVD, the task force suggested the use of eicosapentaenoic acid but not eicosapentaenoic acid plus docosahexaenoic acid and strongly recommended against the use of niacin. There was insufficient evidence for recommendations regarding pharmacologic management in adults with severe hypertriglyceridemia (≥500 mg/dL). The task force suggested a low-density lipoprotein cholesterol treatment goal of <70 mg/dL in adults with dyslipidemia and ASCVD or at increased risk of ASCVD. Conclusions Pharmacotherapy is recommended in adults with dyslipidemia to reduce the risk of ASCVD events. There are several effective and safe treatment options for adults with dyslipidemia who have ASCVD or at increased risk of ASCVD who need additional lipid-lowering medications. Shared decision-making discussions are essential to determine the best option for each individual.
Evidence synthesis and guideline groups have the potential to address health disparities. In June 2024, the Agency for Healthcare Research and Quality (AHRQ) and the Robert Wood Johnson Foundation (RWJF) cosponsored a summit to address racial and ethnic health equity in systematic reviews and other syntheses and guidelines, with support from Cochrane US. This article summarizes cross-cutting themes around future directions for systematic reviews and guidelines. Discussions addressed include the rationale for addressing racial health equity in systematic reviews and guidelines; representation of people with lived experience in systematic reviews and guidelines; approaches to developing and addressing equity-focused scope, including frameworks, methods, and thoughtful interpretation in systematic reviews; challenges and opportunities for guideline recommendations; need for standardized language and reporting for race and ethnicity in primary research studies, systematic reviews, and guidelines; and measures to track the progress of incorporating and addressing racial and ethnic health equity in systematic reviews and guidelines. Participants acknowledged that a one-size-fits-all approach was not possible or desired. Consensus priorities for next steps were to develop methods guidance to address equity in systematic reviews and guidelines; develop measures to track the progress of addressing racial and health equity in systematic reviews and guidelines; operationalize engaging representative interest holders in systematic reviews and guidelines; and share resources and learning for advancing health equity.
BACKGROUND AND AIMS:Primary biliary cholangitis is a chronic cholestatic liver disease that may progress to cirrhosis and liver failure. For patients with inadequate response or intolerance to ursodeoxycholic acid, peroxisome proliferator-activated receptor (PPAR) agonists have emerged as second-line options. This study assessed the comparative effectiveness and safety of PPAR agonists in primary biliary cholangitis through a systematic review and network meta-analysis. APPROACH AND RESULTS:A systematic review identified randomized controlled trials evaluating PPAR agonists versus ursodeoxycholic acid, with or without placebo. A frequentist network meta-analysis assessed biochemical response (primary outcome) and ALP normalization (secondary outcome). Pairwise meta-analyses were performed for percentage change in ALP and total bilirubin, and adverse events leading to treatment discontinuation. Data were stratified by baseline ALP, and a random-effects model was used. Eight randomized controlled trials (727 participants) evaluating 4 PPAR agonists were included. All agents outperformed placebo in achieving biochemical response and ALP normalization. Bezafibrate ranked highest for the primary outcome; both bezafibrate and seladelpar ranked highest for the secondary outcome. Percentage ALP reduction did not vary by baseline ALP. Total bilirubin changes were similar across arms, and treatment discontinuations due to adverse events were infrequent. CONCLUSIONS:PPAR agonists are effective second-line therapies for primary biliary cholangitis. Treatment ranking differences likely reflect variations in outcomes, populations, and drug mechanisms. In the absence of head-to-head trials, network meta-analysis provides important insights into comparative effectiveness. Further studies are warranted to confirm long-term safety and improve the evaluation of patient-centered outcomes.
We performed a systematic review and network meta-analysis (NMA) of individualized patient data (IPD) to inform the development of evidence-informed clinical practice recommendations. We searched MEDLINE, Embase, and Cochrane Central in October 2023 to identify RCTs comparing Hartmann’s resection (HR), primary resection and anastomosis (PRA), or laparoscopic peritoneal lavage (LPL) among patients with class Ib-IV Hinchey diverticulitis. Outcomes of interest were prioritized by an international, multidisciplinary panel including two patient partners. Article screening, data extraction for IPD, and risk of bias appraisal were performed by two reviewers. We used a random-effects NMA to synthesize direct and indirect evidence. Heterogeneity was evaluated using the I2 statistic. The panel appraised the certainty of the evidence using GRADE and CINeMA. Fourteen reports of seven RCTs were derived from 4,659 articles. IPD data were available for 595/678 patients (88.8