An Assessment of Reproducibility Crisis in Published Randomised Controlled Trials in Oral Health - An Evaluative Study.

Intervention Reporting of Published Trials Is Insufficient in Orthopaedic Surgery Journals: Application of the Template for Intervention Description and Replication Checklist

The purpose of this systematic review is to assess adherence to the "template for intervention description and replication" checklist among all published randomized controlled trials of sensory retraining strategies for patients with a history of stroke. Medline, the Cochrane Register of Controlled Trials, and the Physiotherapy Evidence Database were investigated, without time restrictions, until September 1, 2021. In addition, a search for additional studies was carried out using the included studies' reference list. Only randomized controlled trials of adults with a history of stroke who aimed to improve sensation, via any type of intervention, were included. The template for intervention description and replication checklist was used to assess the completeness of reporting on each intervention. A total of 61 trials were included. None of the included studies declared to have used the template for intervention description and replication checklist to report interventions. Overall, the median percentage of adherence to the 12 items of the template for intervention description and replication was 33% (interquartile range, 25%-50%). Only five of the single items were adequately described in more than 50% of the studies. None of the randomized controlled trials reported the entirety of the core intervention components, as described in items 3 to 9. This systematic review demonstrates that interventions in sensory retraining strategy trials are described below desirable standards. Without this information, clinicians and researchers cannot reliably replicate interventions.

Randomized controlled trials (RCTs) play a crucial role in advancing patient care within otolaryngology-head and neck surgery (OTL-HNS), yet studies have shown the reporting of these trials needs improvement. Here, we evaluate the completeness of intervention reporting of RCTs in OTL-HNS and evaluate whether the publication of the Template for Intervention Description and Replication (TIDieR) checklist has influenced intervention reporting. Retrospective Cross-Sectional Analysis. We searched PubMed for RCTs published in top OTL-HNS journals in two cohorts, one before the release of the TIDieR and one afterward. A sample of 300 RCTs was randomly selected and screened for inclusion. Once the dataset was finalized, we extracted trial characteristics and assessed each trial's adherence to the TIDieR checklist. We then used descriptive characteristics, a generalized estimated equation, time-series analysis, and a two-sample t test to analyze our data. After screening was completed, 173 RCTs were included in our analysis. Of these RCTs, 103 (59.5%) showed <60% adherence to the TIDieR checklist. We found a slight increase in adherence to TIDieR items after the checklist was released, although this was not statistically significant (P = .91). In addition, we found that trials with a crossover study design or multiple interventions and those that provided a Consolidated Standards for Reporting Trials statement were associated with greater adherence to the TIDieR checklist. The majority of OTL-HNS RCTs included in our analysis showed suboptimal reporting factors related to the TIDieR checklist. Requiring a TIDieR statement and automating the journal requirements process for all OTL-HNS clinical trials would be a worthwhile, efficient approach to improving research quality and ultimately patient care within OTL-HNS. NA Laryngoscope, 130:E507-E514, 2020.

How completely are physiotherapy interventions described in reports of randomised trials?

BackgroundJournal articles describing randomized controlled trials (RCTs) and systematic reviews with meta-analysis of RCTs are not optimally reported and often miss crucial details. This poor reporting makes assessing these studies’ risk of bias or reproducing their results difficult. However, the reporting quality of diet- and nutrition-related RCTs and meta-analyses has not been explored.ObjectiveWe aimed to assess the reporting completeness and identify the main reporting limitations of diet- and nutrition-related RCTs and meta-analyses of RCTs, estimate the frequency of reproducible research practices among these RCTs, and estimate the frequency of distorted presentation or spin among these meta-analyses.MethodsTwo independent meta-research studies will be conducted using articles published in PubMed-indexed journals. The first will include a sample of diet- and nutrition-related RCTs; the second will include a sample of systematic reviews with meta-analysis of diet- and nutrition-related RCTs. A validated search strategy will be used to identify RCTs of nutritional interventions and an adapted strategy to identify meta-analyses in PubMed. We will search for RCTs and meta-analyses indexed in 1 calendar year and randomly select 100 RCTs (June 2021 to June 2022) and 100 meta-analyses (July 2021 to July 2022). Two reviewers will independently screen the titles and abstracts of records yielded by the searches, then read the full texts to confirm their eligibility. The general features of these published RCTs and meta-analyses will be extracted into a research electronic data capture database (REDCap; Vanderbilt University). The completeness of reporting of each RCT will be assessed using the items in the CONSORT (Consolidated Standards of Reporting Trials), its extensions, and the TIDieR (Template for Intervention Description and Replication) statements. Information about practices that promote research transparency and reproducibility, such as the publication of protocols and statistical analysis plans will be collected. There will be an assessment of the completeness of reporting of each meta-analysis using the items in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement and collection of information about spin in the abstracts and full-texts. The results will be presented as descriptive statistics in diagrams or tables. These 2 meta-research studies are registered in the Open Science Framework.ResultsThe literature search for the first meta-research retrieved 20,030 records and 2182 were potentially eligible. The literature search for the second meta-research retrieved 10,918 records and 850 were potentially eligible. Among them, random samples of 100 RCTs and 100 meta-analyses were selected for data extraction. Data extraction is currently in progress, and completion is expected by the beginning of 2023.ConclusionsOur meta-research studies will summarize the main limitation on reporting completeness of nutrition- or diet-related RCTs and meta-analyses and provide comprehensive information regarding the particularities in the reporting of intervention studies in the nutrition field.International Registered Report Identifier (IRRID)DERR1-10.2196/43537

Assessment of the completeness of intervention reporting of randomized clinical trials for alcohol use disorders: Effect of the TIDieR checklist and guide

To assess the completeness of intervention reporting in randomised controlled trials (RCTs) published in nursing journals based on the Template for Intervention Description and Replication (TIDieR) checklist. A cross-sectional study. RCTs published in English in nursing journals between January 2022 and December 2022 were identified through PubMed. Title- and abstract-screening were undertaken independently by two reviewers to select eligible trials, from which data were extracted. Reports of interventions were likewise independently evaluated based on the TIDieR checklist. Binary logistic regression analysis was performed to investigate potential predictors for the compliance of TIDieR. Our analysis included 303 eligible trials, which generally adhered to most items on the TIDieR checklist, though adherence varied across the trials. Slightly fewer than half of the trials demonstrated good reporting quality. Poor reporting was associated in areas such as modifications, tailoring, and the type of locations where the intervention occurred. Additionally, suboptimal reporting on intervention adherence was noted. Compliance with TIDieR was found to be influenced by factors such as funding availability and the journal's ranking. Our study revealed suboptimal reporting of the TIDieR items in RCTs published in nursing journals. More rigorous adherence to the TIDieR checklist is needed to improve the quality of intervention reporting. Additionally, comparing adherence before and after the implementation of TIDieR may be considered in future investigations. This paper represents the first study to appraise the reporting quality of RCTs in nursing journals based on the TIDieR checklist. Evidence of suboptimal compliance of RCTs to the TIDieR checklist items is presented. No patient or public contribution applied.

<h3>Objective</h3> To evaluate the completeness of exercise prescription in randomised controlled trials (RCTs) for patellofemoral pain (PFP), identify which elements are most frequently missing and supplement recommendations based on additional data from authors. <h3>Design</h3> Systematic review. <h3>Data sources</h3> All studies included in the most recent Cochrane review were evaluated. Additionally, the Cochrane search was updated in June 2016 in Cochrane, MEDLINE, EMBASE, PEDro, CINAHL and AMED databases. Two raters independently assessed completeness of reporting using the Toigo and Boutellier mechanobiological exercise descriptors, and Template for Intervention Description and Replication (TIDieR) checklist. Authors were also contacted to provide additional information. <h3>Eligibility criteria for selecting studies</h3> RCTs of exercise interventions for PFP. <h3>Results</h3> We included 38 RCTs. The level of exercise prescription detail was low, with no study providing complete information. The most commonly reported exercise descriptors were the ’duration of the experimental period9 (n=38/38) and ’number of exercise interventions9 (n=35). From TIDieR, the most commonly reported items were the ’intervention name9 (n=38) and ’rationale9 (n=36). The least reported items from the exercise descriptors were ’volitional muscular failure9, ’temporal distribution of contraction modes9, ’time under tension9 and ’recovery between exercise sessions9 (all n=2/38). From TIDieR, the least reported item was ‘How well (fidelity and adherence)’ (n=3/38). 36 authors were contacted, with 22 replies and 13 providing additional exercise prescription details . <h3>Conclusion</h3> Exercise prescriptions in RCTs with proven efficacy for PFP are poorly reported, impairing their implementation in clinical practice. <h3>PROSPERO registration number</h3> CRD42016039138.

Repetitive transcranial magnetic stimulation (rTMS) is an innovative therapeutic option in major depressive disorder (MDD). A complete description of the procedure in reports of randomized controlled trials (RCTs) is a prerequisite for implementation of rTMS in clinical practice. The aim of this study was to evaluate the completeness of descriptions of the intervention in RCTs assessing rTMS in MDD. We performed a systematic review of RCTs evaluating rTMS in MDD and published until August 2016. We searched PubMed, the Cochrane library, and PsycINFO to identify eligible trials. The completeness of the intervention description was evaluated by the use of an adapted-to-rTMS version of the Template for Intervention Description and Replication (TIDieR) checklist. We defined core items that are the most essential to be reported. Missing information was then sought from additional sources and by e-mailing authors. We identified 98 trials reporting 134 interventions. None of the interventions were completely described in the full text of the articles, even after searching additional sources. After contacting the authors, 14 (10.4%) of 134 interventions were completely described. The core items were completely described in 74 (55.2%) of 134 interventions after contacting the authors. We found that rTMS interventions delivered in RCTs are incompletely reported, which prevents their adequate implementation in clinical practice and accurate interpretation of their efficacy. We encourage authors, editors, and reviewers to use the existing reporting guidelines and specifically the TIDieR checklist when describing the intervention. We provide an adapted-to-rTMS TIDieR checklist that could help in the reporting of future trials.

Intervention reporting and dissemination of information for the management of hand osteoarthritis

Purpose To evaluate the quality of the reporting of exercise interventions with Pilates method for the treatment of lower back pain (LBP) in adults. Materials and methods Two independent evaluators selected randomized controlled trials (RCTs) of moderate and high methodological quality included in a Cochrane Systematic Review (SR) and from an additional updated search in the following databases: CENTRAL, MEDLINE, EMBASE, CINAHL, PEDro and SPORTDiscus. Three assessment tools (Consensus on Therapeutic Exercise Training (CONTENT) scale, Template for Intervention Description and Replication (TIDieR) checklist and Consensus on Exercise Reporting Template (CERT) checklist) were utilized by three pairs of two independent researchers trained. The scales’ concordance was measured using the Kappa coefficient. Results Ten RCTs were included. The CONTENT scale score was 5.3 (± 1.33) out of 9 points; the TIDieR checklist was 8.5 (± 1.71) out of 12 points and the CERT checklist was 9.5 (± 3.62) out of 19 points. The CONTENT and CERT had moderate concordance, while there was fair concordance between the other tools. Conclusions The overall reporting quality for the Pilates exercises in ten moderate-to-high quality RTCs for the management of LBP was low according to CONTENT scale and CERT checklist and high according to TIDieR checklist. Implications for Rehabilitation Reporting of Pilates exercise program in moderate-to-high quality RCTs for the management of lower back pain remains incomplete. Pilates exercise program should be personalized and contextualized to individual participants. There may be a need to consider adding to or combining the information available from various trials.

BackgroundOne of the most common pathologic changes in older people is oral and dental problems. The oral health of older people is a public health concern. Promotion of good oral health for this cohort will have beneficial impacts on the longer-term quality of life. This study aimed to identify the types of health education interventions for the oral health of older people and to determine their effects on the oral and dental health of older people.MethodsPotential articles were retrieved from four electronic databases (PubMed/Medline, Scopus, Web of Sciences, and Embase) up to 31 September 2022 in English without limit of time. Experimental and quasi-experimental interventional studies investigating the impact of educational interventions on oral and dental health among older people over 60 years old in both sexes were considered. The quality assessment tool was the Effective Public Health Practice Project (EPHPP).ResultsIn the initial search, 1104 articles were retrieved. Finally, according to the inclusion criteria, 23 studies (seventeen randomized controlled trials (RCT) and six quasi-experimental studies) were reviewed. In this review, educational interventions for older people and their caregivers are classified. Theoretical frameworks were used in only three interventions related to older people. Outcome measures were both self-reported and objective measures. Fifteen of the included studies were of moderate quality.ConclusionThis review provides evidence that the use of oral and dental health educational interventions was effective in improving the oral health of older people. Educational interventions were carried out both among older people and among their caregivers. Although a variety of interventions were used in the reviewed studies, more lectures were used in the interventions related to older people. In the interventions related to caregivers, in addition to lectures, practical education was also used. It is recommended to perform higher quality studies for assessing the effectiveness of interventions in this field.

Community-based services to sustain independence for older people have varying configurations. A typology of these interventions would improve service provision and research by providing conceptual clarity and enabling the identification of effective configurations. We aimed to produce such a typology. We developed our typology by qualitatively synthesising community-based complex interventions to sustain independence in older people, evaluated in randomised controlled trials (RCTs), in four stages: (i) systematically identifying relevant RCTs; (ii) extracting descriptions of interventions (including control) using the Template for Intervention Description and Replication; (iii) generating categories of key intervention features and (iv) grouping the interventions based on these categories. PROSPERO registration: CRD42019162195. Our search identified 129 RCTs involving 266 intervention arms. The Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology comprises 14 action components and 5 tailoring components. Action components include procedures for treating patients or otherwise intended to directly improve their outcomes; regular examples include formal homecare; physical exercise; health education; activities of daily living training; providing aids and adaptations and nutritional support. Tailoring components involve a process that may result in care planning, with multiple action components being planned, recommended or prescribed. Multifactorial action from care planning was the most common tailoring component. It involves individualised, multidomain assessment and management, as in comprehensive geriatric assessment. Sixty-three different intervention types (combinations) were identified. Our typology provides an empirical basis for service planning and evidence synthesis. We recommend better reporting about organisational aspects of interventions and usual care.

Purpose Primary care practitioners (PCPs) are central to managing major depressive disorder (MDD), a leading cause of global disability. However, the translation of research into practice is often hindered by poor reporting of interventions. This study aims to systematically evaluate the completeness of intervention reporting in randomized controlled trials (RCTs) concerning MDD treatments delivered by PCPs, using the Template for Intervention Description and Replication (TIDieR) checklist. It also seeks to identify study characteristics associated with higher-quality reporting to inform future research standards. Design/methodology/approach The authors conducted a cross-sectional metaresearch study, systematically searching six electronic databases for RCTs published up to October 7, 2024. Eligible studies involved adult patients with MDD receiving any intervention from PCPs. Two authors independently screened records, extracted data and assessed the reporting completeness of each intervention against the 12-item TIDieR checklist. Univariate linear regression models were used to explore associations between study characteristics and TIDieR completion scores. Findings Across 22 included RCTs describing 34 interventions, the median TIDieR completion score was 55.64%. No intervention was fully described according to all 12 TIDieR items. While the intervention’s name was always provided (100% compliance), the mode of delivery was the least reported item (20.59%). Pharmacological interventions were the most frequent category (55.88%). Larger trial size was a predictor of better reporting, whereas reporting of participants’ consent was associated with poorer reporting. Research limitations/implications The limited sample size (22 studies) reduces the statistical power and generalizability of our regression analyses. Many included studies were over 20 years old, potentially not reflecting contemporary reporting standards. The variability in diagnostic criteria for MDD across studies also complicates direct comparisons. These limitations highlight the need for greater standardization in both diagnostic and reporting practices in psychiatric research to ensure findings are comparable and replicable. TIDieR itself does not assess intervention quality, only reporting completeness. Practical implications The suboptimal and inconsistent reporting of interventions for MDD severely impedes their replication in clinical practice and slows the implementation of evidence-based care. Clinicians cannot confidently apply interventions when crucial details on delivery, tailoring and fidelity are missing. The findings serve as a call to action for researchers, journal editors and peer reviewers to mandate and adhere to reporting guidelines like TIDieR. This would enhance the transparency, utility and ultimate impact of clinical research in primary care settings. Social implications MDD is a leading contributor to the global burden of disease, with most patients managed in primary care. Poor research reporting acts as a barrier to disseminating effective treatments, meaning patients may not benefit from scientific advances. By improving the clarity and completeness of intervention descriptions, the research community can better support PCPs in delivering effective, evidence-based care. This, in turn, can lead to improved mental health outcomes at a population level, reducing the profound societal impact of depression. Originality/value This study provides a novel, systematic evaluation of intervention reporting quality specifically for MDD management within the crucial context of primary care. By applying the TIDieR checklist, it quantifies specific reporting gaps – such as the near-universal failure to describe the mode of delivery – that directly impact the replicability of research. The findings uniquely highlight that pharmacological trials dominate this research landscape, while other modalities like psychotherapy are underrepresented. The work underscores the urgent need for improved reporting standards to bridge the gap between research and clinical practice.

ObjectiveTo evaluate the completeness of exercise prescription in randomised controlled trials (RCTs) for patellofemoral pain (PFP), identify which elements are most frequently missing and supplement recommendations based on additional data...