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Purpose: Reporting guidelines (eg, Consolidated Standards of Reporting Trials [CONSORT] statement) are intended to improve reporting standards and enhance the transparency and reproducibility of research findings. Despite accessibility of such guidelines, researchers are not required to adhere to them. Our goal was to determine the current status of reporting quality in the medical literature and examine whether adherence of reporting guidelines has improved since the inception of reporting guidelines. Materials and methods: Eight reporting guidelines, such as CONSORT, Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), STrengthening the Reporting of OBservational studies in Epidemiology (STROBE), Quality of Reporting of Meta-analysis (QUOROM), STAndards for Reporting of Diagnostic accuracy (STARD), Animal Research: Reporting In Vivo Experiments (ARRIVE), Consolidated Health Economic Evaluation Reporting Standards (CHEERS), and Meta-analysis of Observational Studies in Epidemiology (MOOSE) were examined. Our inclusion criteria included reviews published between January 1996 to September 2016 which investigated the adherence to reporting guidelines in the literature that addressed clinical trials, systematic reviews, observational studies, meta-analysis, diagnostic accuracy, economic evaluations, and preclinical animal studies that were in English. All reviews were found on Web of Science, Excerpta Medical Database (EMBASE), MEDLINE, and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Results: Among the general searching of 26,819 studies by using the designed searching method, 124 studies were included post screening. We found that 87.9% of the included studies reported suboptimal adherence to reporting guidelines. Factors associated with poor adherence included non-pharmacological interventions, year of publication, and trials concluding with significant results. Improved adherence was associated with better study designs such as allocation concealment, random sequence, large sample sizes, adequately powered studies, multiple authorships, and being published in journals endorsing guidelines. Conclusion: We conclude that the level of adherence to reporting guidelines remains suboptimal. Endorsement of reporting guidelines by journals is important and recommended. [ABSTRACT FROM AUTHOR]

Purpose: This systematic survey evaluates the completeness of reporting in pilot and feasibility randomized controlled trials investigating behavioral interventions based on the Consolidated Standards of Reporting Trials (CONSORT) extension for pilot trials. Methods: The authors searched Medline/Pubmed and randomly selected 100 articles from 2012 through 2016 to determine the proportion of reported CONSORT extension items. They examined study factors related to reporting, including year and country of publication, psychotherapy intervention, multiple centers, industry funding, and journal endorsement of CONSORT. Results: The authors found that the mean reporting score on the CONSORT extension was 51.6% (SD = 15.1). Studies of psychotherapy interventions had significantly higher reporting scores than other interventions (incidence rate ratio = 1.10, 95% confidence interval: 1.01-1.20). Conclusions: Our findings indicate that current reporting quality is suboptimal. Many included trials failed to provide rationale for piloting, assess feasibility objectives, or indicate clear progression to a future large trial. Reporting quality should be reevaluated following uptake of the 2016 CONSORT extension for pilot trials. [ABSTRACT FROM AUTHOR]

Behavioral and social sciences randomized controlled trials (BSSTs) have a significant role in life sciences. Choosing an appropriate control or comparator group for BSSTs is critical, to provide true intervention effects. The objective of this study was to determine the types of control groups used in BSSTs, and the rationale provided to justify these choices. We conducted a systematic survey of BSST protocols published between January 2012 and October 2016 in the Cochrane Library and Medline databases. We randomly selected 200 protocols. The study selection and data extraction were performed independently in duplicate. The most frequent control groups were active concurrent (97/200, 48.5%), and no treatment concurrent controls (88/200, 44.0%). The majority of studies (71.5%) did not provide justification for comparators choice. We concluded that BSSTs trials compare interventions to active and no treatment controls however the majority of trials lacked rationale for the selection of the study comparator. [ABSTRACT FROM AUTHOR]

The article reports on the systematic review showing inconsistent findings of the effect of denosumab on children with osteogenesis imperfecta (OI), a rare, inherited disorder characterised by increased bone fragility, reduced bone mass and often short stature. It calls on for the need of large-scale, well-designed, long-term studies to clarify the effect of denosumab on paediatric patients with OI.

Background: Evidence shows that research abstracts are commonly inconsistent with their corresponding full reports, and may mislead readers. In this scoping review, which is part of our series on the state of reporting of primary biomedical research, we summarized the evidence from systematic reviews and surveys, to investigate the current state of inconsistent abstract reporting, and to evaluate factors associated with improved reporting by comparing abstracts and their full reports.Methods: We searched EMBASE, Web of Science, MEDLINE, and CINAHL from January 1st 1996 to September 30th 2016 to retrieve eligible systematic reviews and surveys. Our primary outcome was the level of inconsistency between abstracts and corresponding full reports, which was expressed as a percentage (with a lower percentage indicating better reporting) or categorized rating (such as major/minor difference, high/medium/low inconsistency), as reported by the authors. We used medians and interquartile ranges to describe the level of inconsistency across studies. No quantitative syntheses were conducted. Data from the included systematic reviews or surveys was summarized qualitatively.Results: Seventeen studies that addressed this topic were included. The level of inconsistency was reported to have a median of 39% (interquartile range: 14% - 54%), and to range from 4% to 78%. In some studies that separated major from minor inconsistency, the level of major inconsistency ranged from 5% to 45% (median: 19%, interquartile range: 7% - 31%), which included discrepancies in specifying the study design or sample size, designating a primary outcome measure, presenting main results, and drawing a conclusion. A longer time interval between conference abstracts and the publication of full reports was found to be the only factor which was marginally or significantly associated with increased likelihood of reporting inconsistencies.Conclusions: This scoping review revealed that abstracts are frequently inconsistent with full reports, and efforts are needed to improve the consistency of abstract reporting in the primary biomedical community. [ABSTRACT FROM AUTHOR]

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Objectives: This study aimed to investigate how value is defined and measured in existing value assessment frameworks (VAFs) in healthcare.Methods: We searched PubMed, Embase, the Cochrane Library, and Centre for Reviews and Dissemination from 2008 to 2019. We also performed backward citation chaining of included studies and previously published systematic reviews. Studies reporting the development of a VAF in healthcare were included. For each included framework, we extracted and compared the context, target users, intended use, methods used to identify value attributes, description of the attributes, and attribute scoring approaches.Results: Of the 8151 articles screened, 57 VAFs were included. The value attributes included in 55 VAFs were grouped into 9 categories: health benefits (n = 53, 96%), affordability (n = 45, 82%), societal impact (n = 42, 76%), burden of disease (n = 36, 65%), quality of evidence (n = 32, 58%), cost-effectiveness (n = 31, 56%), ethics and equity (n = 27, 49%), unmet needs (n = 21, 38%), and innovation (n = 15, 27%). The remaining 2 VAFs used broad attributes or user-defined attributes. Literature review was the main approach to identify value attributes in 36 VAFs. Patient or public was engaged through the development of only 11 VAFs. Weighting has been used to score 29 VAFs, of which 19 used the methods of multicriteria decision analysis.Conclusions: There are substantial variations in defining and measuring value. A noticeable weakness of existing VAFs is that patient or public engagement was generally very limited or missing in framework development process. Existing VAFs tend to aggregate multiple value attributes into a single index for decision making. [ABSTRACT FROM AUTHOR]

Background: Evidence on the long-term clinical benefits of individual members of angiotensin II receptor blockers is limited given the lack of head-to-head studies. We conducted a network meta-analysis to determine the comparative efficacy of different members within this drug class with respect to outcomes of (i) blood pressure reduction (at 24 and 52 weeks) and (ii) prevention of cardiovascular disease (>104 weeks).Methods: A systematic literature review was conducted - Protocol registration: (PROSPERO - CRD42014007067) - to identify relevant literature from the following databases: Cochrane Library, PubMed, Medline and EMBASE; searched from inception to July 2016. Randomised controlled trials (RCTs) were included if they reported long-term effectiveness relating to blood pressure, mortality, myocardial infarction or stroke. Eligible studies included those with placebo or specific active-treatment comparators (either another angiotensin II receptor blockers or hydrochlorothiazide). A Bayesian random-effects network model was used to combine direct within-trial comparisons between treatment groups with indirect evidence from other trials.Results: Thirty-six studies were identified, representing 28 unique trials. Blood pressure reduction, based on 12 studies (n=807) with fixed dosing regimen, was found to be similar amongst members of the angiotensin receptor blocker drug class at both 24 and 52 weeks. A network meta-analysis of five studies (n=16,716) with a treat-to-target approach found that prevention of all-cause mortality, stroke and myocardial infarction was similar across the angiotensin-receptor blockers therapies initiated.Conclusions: Current evidence is insufficient to show differences in any members within the angiotensin II receptor blocker drug class with respect to blood pressuring lowering effects or a reduction in cardiovascular diseases. [ABSTRACT FROM AUTHOR]