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The objective of the study is to assess the interrater reliability (IRR) and usability of the revised Cochrane risk of bias tool for randomized trials (RoB 2). This is a cross-sectional study. Four raters independently applied RoB 2 on the primary outcome of a random sample of individually randomized parallel-group trials (randomized controlled trials (RCTs)). We calculated the Fleiss’ kappa for multiple raters, the time needed to complete the tool, and discussed the application of RoB 2 to identify difficulties and reasons for disagreement. A total of 70 outcomes from 70 RCTs were included. IRR was slight for overall judgment (IRR 0.16, 95% confidence interval (CI) 0.08–0.24); individual domain analysis gave IRR as moderate for “randomization process” (IRR 0.45, 95% CI 0.37–0.53), slight for “deviations from intended intervention” for RCTs assessing the effect of the assignment to an intervention (IRR 0.04, 95% CI −0.06 to 0.14), fair for those assessing the effect of adhering (IRR 0.21, 95% CI 0.11–0.31), and fair for the other domains, ranging from 0.22 (95% CI 0.14–0.30) for “missing outcome data” to 0.30 (95% CI 0.22–0.38) for “selection of reported results”. Mean time to apply the tool was 28 minutes (standard deviation 13.4) per study outcome. The main difficulties were due to poor knowledge of the subject matter of primary studies, new terminology, different approaches for some domains compared with the previous tool, and way of formulating signaling questions. RoB 2 is a detailed and comprehensive tool but difficult and demanding, even for raters with substantial expertise in systematic reviews. Calibration exercises and intensive training are needed before its application, to improve reliability.

-AGREE II overall assessments are poorly reported in rehabilitation appraisals of clinical practice guidelines (CPGs).-Two third of appraisals applied cut-offs to judge guideline quality-Quality ratings of guidelines varied moderately applying different cut-offs To analyze the reporting characteristics of Appraisal of Guidelines Research and Evaluation (AGREE) II appraisals in rehabilitation and explore how much quality ratings of Clinical Practice Guidelines (CPGs) vary applying different cut-offs. We conducted a methodological study re-analyzing data of an overview of AGREE II CPG appraisals in rehabilitation. Reporting characteristics of appraisals and methods used for quality rating were abstracted. We applied the most frequent cut-offs retrieved on all CPG sample to explore changes in quality ratings (i.e., high/low). We included 40 appraisals (n = 544 CPGs).The AGREE II overall assessment 1 (overall CPG quality) was reported in 26 appraisals (65%) and the overall assessment 2 (recommendation for use) in 17 (42.5%). Twenty-five appraisals (62.5%) reported the use of cut-offs based on domains and/or overall assessments. Application of the most reported cut-offs led to variability in quality ratings in 26% of the CPGs, of which 92% CPGs shifted their rating from low to high-quality and 8% shifted from high to low-quality. Rehabilitation stakeholders should take care to select the highest quality CPG in view of the poor reporting of AGREE II overall assessment 1 and 2 and moderate variability of quality ratings.

Strongyloides stercoralis infection is a neglected tropical disease which can lead to severe symptoms and even death in immunosuppressed people. Unfortunately, its diagnosis is hampered by the lack of a gold standard, as the sensitivity of traditional parasitological tests (including microscopic examination of stool samples and coproculture) is low. Hence, alternative diagnostic methods, such as molecular biology techniques (mostly polymerase chain reaction, PCR) have been implemented. However, there are discrepancies in the reported accuracy of PCR. A systematic review with meta-analysis was conducted in order to evaluate the accuracy of PCR for the diagnosis of S. stercoralis infection. The protocol was registered with PROSPERO International Prospective Register of Systematic Reviews (record: CRD42016054298). Fourteen studies, 12 of which evaluating real-time PCR, were included in the analysis. The specificity of the techniques resulted high (ranging from 93 to 95%, according to the reference test(s) used). When all molecular techniques were compared to parasitological methods, the sensitivity of PCR was assessed at 71.8% (95% CI 52.2-85.5), that decreased to 61.8% (95% CI 42.0-78.4) when serology was added among the reference tests. Similarly, sensitivity of real-time PCR resulted 64.4% (95% CI 46.2-77.7) when compared to parasitological methods only, 56.5% (95% CI 39.2-72.4) including serology. PCR might not be suitable for screening purpose, whereas it might have a role as a confirmatory test.

Objectives: A combination of chemotherapy and radiotherapy is employed in the curative and postoperative treatment of locally advanced head and neck cancers (HNC). Integrated chemoradiation (CRT) treatments result in a non-negligible rate of severe toxic effects. Treatment-related death (TRD) is a crucial topic for physicians involved in the curative treatment of HNC. This meta-analysis aimed to better address TRD in locally advanced HNC patients treated with CRT through available and relevant literature. Methods: We performed a systematic review of the literature according to the PRISMA statement. The studies fulfilling these criteria included the following: concurrent or alternating CRT; both radical and postoperative settings; published from 2000 to 2020; involving 100+ patients; and available toxicity data. TRD was defined as death occurring from CRT start until a month from the end of CRT. Potential TRD predictors were evaluated. Results: In all, 65 studies were retrieved, with a total of 235 TRDs reported accounting for an overall risk rate of 1.4%. At meta-regression analysis, T stage and neutropenia grade >3 were potential predictors of higher TRD risk, both in univariate and multivariate analyses. Considering only the studies reporting at least one event, laryngeal/hypopharyngeal, oral cavity subsites and renal failure were significant predictors for TRD. The oropharyngeal subsite was protective in both analyses. None of the predictors proved to be independently correlated with TRD at multivariable analysis. Conclusion: CRT in HNC resulted in 1.4% of TRDs. TRD rate reduction may imply better patient selection and more intensive supportive care programs.

Background Systematic reviews can apply the Appraisal of Guidelines for Research & Evaluation (AGREE) II tool to critically appraise clinical practice guidelines (CPGs) for treating low back pain (LBP); however, when appraisals differ in CPG quality rating, stakeholders, clinicians, and policy-makers will find it difficult to discern a unique judgement of CPG quality. We wanted to determine the proportion of overlapping CPGs for LBP in appraisals that applied AGREE II. We also compared inter-rater reliability and variability across appraisals. Methods For this meta-epidemiological study we searched six databases for appraisals of CPGs for LBP. The general characteristics of the appraisals were collected; the unit of analysis was the CPG evaluated in each appraisal. The inter-rater reliability and the variability of AGREE II domain scores for overall assessment were measured using the intraclass correlation coefficient and descriptive statistics. Results Overall, 43 CPGs out of 106 (40.6%) overlapped in seventeen appraisals. Half of the appraisals (53%) reported a protocol registration. Reporting of AGREE II assessment was heterogeneous and generally of poor quality: overall assessment 1 (overall CPG quality) was rated in 11 appraisals (64.7%) and overall assessment 2 (recommendation for use) in four (23.5%). Inter-rater reliability was substantial/perfect in 78.3% of overlapping CPGs. The domains with most variability were Domain 6 (mean interquartile range [IQR] 38.6), Domain 5 (mean IQR 28.9), and Domain 2 (mean IQR 27.7). Conclusions More than one third of CPGs for LBP have been re-appraised in the last six years with CPGs quality confirmed in most assessments. Our findings suggest that before conducting a new appraisal, researchers should check systematic review registers for existing appraisals. Clinicians need to rely on updated CPGs of high quality and confirmed by perfect agreement in multiple appraisals. Trial Registration Protocol Registration OSF: https://osf.io/rz7nh/

Background The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM). Methods The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes. Results Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low. Conclusions NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.

Background The use of systematic review methods are widely recognized to be essential in the development of recommendations in clinical practice guidelines to prove their trustworthiness. The objective of this study was to assess the use of systematic search methods by authors of guidelines published in the oncology field. Methods We analyzed 590 guidance documents identified in PubMed, NGC, GIN and web sites for guidelines in 2009–2015 in oncology. The main outcome measure used was incidence of guidance documents supported by a systematic search of the literature. In addition to descriptive analyses, logistic regression was used to evaluate if adequate search methods were explained by guideline characteristics. Results Of 590 guidance documents included in the study, 305 (51.7%) declared the use of systematic search methods but only 168 (28.5%) applied methods meeting minimum standards for quality and provided sufficient details to allow classification. 164 (27.8%) guidance documents did not report any use of literature evaluation. Guidance documents produced by a Government Agency in North America (OR 2.16, 95% CI 1.16–4.17) and those with a focused scope (OR 2.35, 95% CI 0.97–5.56) were positively associated with the use of systematic search methods. We found no association between the year of publication and use of systematic search methods. Conclusions A relatively small number of guidance documents was informed by scientific evidence identified through adequate systematic search methods. We observed substantial room for improvement of applied methods and reporting, especially in documents with a broad focus, or those produced by professional societies or independent expert panels in other continents than North America.

Background Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. Methods/Design The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. Discussion The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. Trial registration ClinicalTrials.gov, NCT02645357

The objective of the study was to assess the inter-rater reliability (IRR) of AMSTAR and ROBIS in judging individual domains and overall methodological quality/risk of bias of systematic reviews, the concurrent validity of the tools, and the time required to apply them. This is a cross-sectional study. Five raters independently read 31 systematic reviews and applied AMSTAR and ROBIS. Fleiss' k for multiple raters for individual domains and overall methodological quality/risk of bias was calculated. Similar domains assessed by both tools and final scores were matched to explore the concurrent validity, using the Kendall tau correlation. IRR ranged from fair to perfect for AMSTAR and from moderate to substantial for ROBIS. Kappa for overall quality/risk of bias was 0.73 (95% confidence interval [CI] 0.65–0.81) for AMSTAR and 0.64 (95% CI 0.54–0.74) for ROBIS. We judged most of the reviews at intermediate quality with AMSTAR (53%), while judgments were split in high (53%) and low (47%) risk of bias with ROBIS. The correlation between judgments on similar domains ranged from moderate to high, while it was fair on the overall judgment (K = 0.35, 95% CI 0.21–0.49). The mean time to complete ROBIS was about double that for AMSTAR. AMSTAR and ROBIS offer similar IRR but differ in their construct and applicability.

To assess the inter-rater reliability (IRR) and usability of the risk of bias in nonrandomized studies of interventions tool (ROBINS-I). We designed a cross-sectional study. Five raters independently applied ROBINS-I to the nonrandomized cohort studies in three systematic reviews on vaccines, opiate abuse, and rehabilitation. We calculated Fleiss' Kappa for multiple raters as a measure of IRR and discussed the application of ROBINS-I to identify difficulties and possible reasons for disagreement. Thirty one studies were included (195 evaluations). IRRs were slight for overall judgment (IRR 0.06, 95% CI 0.001 to 0.12) and individual domains (from 0.04, 95% CI −0.04 to 0.12 for the domain “selection of reported results” to 0.18, 95% CI 0.10 to 0.26 for the domain “deviation from intended interventions”). Mean time to apply the tool was 27.8 minutes (SD 12.6) per study. The main difficulties were due to poor reporting of primary studies, misunderstanding of the question, translation of questions into a final judgment, and incomplete guidance. We found ROBINS-I difficult and demanding, even for raters with substantial expertise in systematic reviews. Calibration exercises and intensive training before its application are needed to improve reliability.