Analysis of the quality of reporting of randomized controlled trials in anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis as governed by the CONSORT statement
“…Of the 37 checklist items, 25 were addressed in ≥75% ( Figure1B ). The Methods domain rate was lower (69.7%), consistent with previous findings [ 7 , 8 , 9 ], but important to report methodological items for validity and applicability of trial results. Figure 1 (A) PRISMA Flow diagram of the study selection process.…”
“…Of the 37 checklist items, 25 were addressed in ≥75% ( Figure1B ). The Methods domain rate was lower (69.7%), consistent with previous findings [ 7 , 8 , 9 ], but important to report methodological items for validity and applicability of trial results. Figure 1 (A) PRISMA Flow diagram of the study selection process.…”
“…Only RCTs of high-ranked medical journals showed superior adherence to the CONSORT statement giving statistically significant results ( p < 0.05) and additionally a strong linear correlation ( r = 0.740). IF was previously studied and a number of studies demonstrated an important association between IF and reporting quality [ 28 , 29 , 32 , 34 ]. This is because journals with a higher IF have more strictrules for the publication of studies.…”
Section: Discussionmentioning
confidence: 99%
“…The period from January 2011until December 31st, 2021 was assessed.It was decided that the remaining part of 2020 would not be evaluated in order to provide a sufficient time for authors to conform with the newest recommendations.The primary outcome measure was the mean CONSORT adherence of the included RCTs.Compliance above 75% with the CONSORT items was regarded as cut-off [ 31 , 32 ]. We investigated the adherence of each itemseparately and the existence of possible determinant factors were also investigated.…”
Section: Methodsmentioning
confidence: 99%
“…Our team, in a previous study concerning anticoagulant versus antiplatelet medication for venous thromboembolism prophylaxis, the average CONSORT compliance score was found to be 59.69% (38–83%). Only one RCT achievedmore than 75% of the CONSORT items (83%) [ 32 ].…”
Background—Purpose
Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine, yet their quality is often suboptimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is a list of advice to upgrade the quality of RCTs. The aim of this study was the assessment of the quality of RCTs for vitamin D supplements in thyroid autoimmunity according to the revised CONSORT 2010 checklist.
Methods
Databases were searched for RCTs involving patients with autoimmune thyroid disorders (AITDs) who received vitamin D supplements published from 2011 to 2021. A list of 37-items was used and adherence ≥75% was considered of optimal quality. The primary outcome was the mean CONSORT adherence of studies. Secondary outcomes were the estimation of compliance per CONSORT item and the examination for possible determinants of the reporting quality.
Results
Thirteen eligible trials were finally included. The mean compliance was 61.15% ± 14.86%. Only threeof the studies (23%) achieved a good reporting quality (≥75%), while ten (77%) were presented with inadequate reporting (<75%). Randomization and blinding were mainly poorly reported. Impact Factor (IF) of journal was associated with the reporting quality in the univariate analysis [
p
= 0.033, OR = 1.65, 95%CI = (1316, 1773)]. Sample size (
p
= 0.067), number of authors (
p
= 0.118) and number of citations (
p
= 0.125) were marginally not significant. None of the factors showed significant results in multivariate analysis. Reporting quality and IF were strongly positively correlated [Pearson’s r = 0.740,
p
= 0.04].
Conclusion
This study shows that mean CONSORT adherence of RCTs for Vitamin D supplementation in AITDs is moderate, reflecting that study quality and transparency could be improved with better adherence to CONSORT rules.
“…[3] Finally, each item in the CONSORT Checklist carries an equal weight that can be weighed differently in different studies; hence, reporting the entire score may not reflect the overall quality of the reported RCTs. [22,25] To compensate for this, we modified the CONSORT Checklist from 37 to 28 items and investigated the reporting of certain important issues in detail (Tables 1-3). [21,31] Our study has several implications.…”
Background:
Medical therapy has become an increasingly important intervention owing to improvements in the multidisciplinary care for pituitary adenomas (PAs). This study aimed to assess the reporting quality of randomized controlled trials (RCTs) on PAs pharmacotherapy.
Methods:
RCTs evaluating the efficacy of pharmacotherapy in PAs published in English between January 1, 1974, and December 31, 2022, were searched for and collected from PubMed and MEDLINE. The 2010 Consolidated Standards for Test Reports (CONSORT) statement-based 28 items overall quality score (OQS) was used to evaluate the overall quality of each report.
Results:
Twenty-seven related RCTs including 1816 patients were retrieved. The median OQS score was 12 (range, 6–19) on a scale of 0 to 28. Important items, such as background, objectives, participants, interventions, and outcomes, were sufficiently reported in 100% (27/27) of the articles. Statistical methods were adequately described in 93% (25/27) of patients. However, RCTs underreported identification as randomized trials in the title (3/27, 11%), sample size, allocation concealment, implementation, ancillary analysis method, and Diagram and Ancillary analyses (1/27, 4%). The OQS of published RCTs has significantly increased since 2010 (P = .012). The multivariate final model showed significant associations between higher OQS and publication since 2010 and enrollment of more than 100 patients.
Conclusions:
The overall reporting quality of RCTs on pharmacotherapy in PAs was poor, based on the 2010 CONSORT statement. However, we noticed an improvement in the OQS over the years and identified the factors associated with a better report. Increased effort is necessary to raise awareness of these issues among writers, readers, reviewers, and editors.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
