Objectives: Efforts to enhance the reporting of clinical trials have intensified in recent years with automated strategies and editorial involvement showing promise in improving compliance with accepted guidelines. This study aimed to evaluate the effectiveness of a concerted approach to adherence to CONSORT (CONsolidated Standards Of Reporting Trials) guidelines in a dental journal.
Materials And Methods: Following the publication of an exemplar clinical trial on the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) website and related changes to the author guidelines, trial submissions were required to follow a standard format incorporating subheadings mirroring the CONSORT guidelines. Compliance with CONSORT was assessed in initial submissions over a 30-month period. Reporting was compared to submissions of randomized controlled trials (RCTs) which did not include subheadings over the same period.
Results: Seventy-one RCTs were submitted to the AJO-DO from January 2014 to June 2016, 49 with subheadings and 22 without. Most CONSORT items (e.g. random sequence generation, allocation concealment and blinding) were more frequently adequately reported when RCTs were submitted with inclusion of subheadings. Overall, reporting quality of the submitted RCTs was 15.2% higher with use of the subheadings format (95%CI: 10.5, 20.0; p<0.001) with a mean overall score of 87.3%.
Conclusion: Enhanced compliance of submitted RCTs was found with use of a bespoke approach to trial presentation utilizing CONSORT item subheadings. The improvement in initial submissions is particularly encouraging as this arose without input either from peer reviewers or journal editors. This simple approach may have wider applicability.
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http://dx.doi.org/10.1016/j.jdent.2017.09.009 | DOI Listing |
Surg Obes Relat Dis
November 2024
Department of Hygiene and Dietetics, Chair of Epidemiology and Preventive Medicine, Jagiellonian University Medical College, Krakow, Poland; Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland. Electronic address:
Background: Metabolic and bariatric surgery (MBS) is considered the most effective treatment for people with severe obesity, and certain interventions could enhance its long-term results. The complete reporting of interventions' details is necessary for their replication in clinical settings.
Objectives: To investigate the completeness of reporting of lifestyle and nutritional interventions applied in immediate perioperative period (30-days preoperatively and postoperatively) in patients undergoing MBS using the 12-item Template for Intervention Description and Replication (TIDieR) checklist, and to explore factors associated with compliant reporting.
Lancet Reg Health Eur
January 2025
Harding Center for Risk Literacy, Faculty of Health Sciences Brandenburg, University of Potsdam, Virchowstr. 2, Potsdam 14482, Germany.
Background: Despite notable advancements in artificial intelligence (AI) that enable complex systems to perform certain tasks more accurately than medical experts, the impact on patient-relevant outcomes remains uncertain. To address this gap, this systematic review assesses the benefits and harms associated with AI-related algorithmic decision-making (ADM) systems used by healthcare professionals, compared to standard care.
Methods: In accordance with the PRISMA guidelines, we included interventional and observational studies published as peer-reviewed full-text articles that met the following criteria: human patients; interventions involving algorithmic decision-making systems, developed with and/or utilizing machine learning (ML); and outcomes describing patient-relevant benefits and harms that directly affect health and quality of life, such as mortality and morbidity.
Indian J Psychol Med
December 2024
Dept. of Biostatistics, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, Karnataka, India.
Background: Though cluster randomized trials (CRTs) provide robust evidence for intervention by controlling contamination of interventions, there could be some loss of statistical efficiency. The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting intraclass correlation coefficients (ICC) to understand this phenomenon, though not many studies follow this. This meta-analysis explored the compliance of CRTs in major depression for reporting ICC besides deriving the pooled ICC and pooled mean differences of intervention outcomes.
View Article and Find Full Text PDFEndocrine
November 2024
Postgraduate Program in Medical Sciences: Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Background: The American Academy of Orthopaedic Surgeons (AAOS) publishes clinical practice guidelines (CPGs) for various pathologies. An extension to the Consolidated Standards for Reporting (CONSORT) checklist provides authors with a framework for reporting harms in randomized controlled trials (RCTs).
Objectives: The purpose of this study was to measure harms reporting among RCTs cited as supporting evidence for the AAOS CPG on the treatment of clavicle fractures.
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