CONSORT Items Research Articles

Reporting Quality and Risk of Bias Analysis of Published RCTs Assessing Anti-CGRP Monoclonal Antibodies in Migraine Prophylaxis: A Systematic Review.

Objective: Phase II/III randomized clinical trials (RCTs) are vulnerable to many types of bias beyond randomization. Insights into the reporting quality of RCTs involving migraine patients treated with monoclonal antibodies targeting the calcitonin gene-related peptide system (anti-CGRP MAbs) are currently lacking. Our aim was to analyze the reporting quality of phase II/III RCTs involving migraine patients treated with anti-CGRP MAbs. Methods: A systematic search was performed on the PubMed and EMBASE databases, according to PRISMA guidelines, for relevant RCTs in either episodic or chronic migraine prevention. Additionally, an adapted version of the 2010 CONSORT statement checklist was utilized. The ROBvis online tool was used to document the risk of bias. Results: From the initially identified 179 articles, we finally found 31 RCTs that were eligible for evaluation. The average CONSORT compliance was 88.7% (69.7-100%), while 93.5% (N = 29) of the articles had a compliance greater than 75%. Twenty-eight CONSORT items were reported in more than 75% of the articles. The average compliance of the analyzed RCTs was 93.9% for Galcanezumab, 91.3% for Fremanezumab, followed by 85.4% for Erenumab and Eptinezumab studies. Implementation of the ROB2 tool showed some concerning "missing information" arising from the inadequate reporting. Specifically, 50% of the studies (N = 16) were categorized as having inadequate information regarding the randomization process. Conclusions: Adequate reporting quality was disclosed in the evaluated RCTs with anti-CGRP MAbs in migraine prevention. However, some methodological issues need to be highlighted to be addressed in future studies assessing the efficacy of new molecules targeting CGRP or other candidate pathways implicated in migraine pathophysiology.

Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study

Background and objectiveIntegrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions.MethodsThrough a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared.ResultsA total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44–28.19), 14.17 (13.98–14.37) and 21.06 (20.69–21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items.ConclusionAlthough the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

Completeness of Reporting in Abstracts of Randomized Controlled Trials Assessing Interventional Radiology for Liver Disease

PurposeTo assess the completeness of reporting in abstracts of published randomized controlled trials (RCTs) assessing interventional radiology (IR) for liver disease; to assess whether publication of the 2017 CONSORT update for nonpharmacologic treatments (NPTs) resulted in changes in abstract reporting; and to identify factors associated with better reporting. Materials and MethodsMEDLINE and Embase were searched to identify RCTs of IR for liver disease (January 2015 to September 2020). Two reviewers assessed the completeness of abstract reporting according to the CONSORT-NPT-2017-update. The primary outcome was the mean number of CONSORT items completely reported among 10 items reported in <50% of the abstracts published in 2015. A time series analysis assessed the evolution trend over time. Moreover, a multivariate regression model was used to identify factors associated with better reporting. ResultsA total of 107 abstracts of RCTs published in 61 journals were included. Overall, 74% (45/61) of journals endorsed the main CONSORT guidelines, of which 60% (27/45) had a policy to implement them. The mean number of primary outcome items completely reported increased by 0.19 over the study period. The publication of the CONSORT-NPT update did not lead to an increase in the trend of items reported (increase of 0.04 items/month before vs 0.02 after; P = .41). Factors associated with more complete reporting were impact factor (OR = 1.13; 95% CI: 1.07–1.18) and endorsement of CONSORT with an implementation policy (OR = 8.29; 95% CI: 2.04–33.65). ConclusionsCompleteness of reporting is incomplete in abstracts of trials of IR liver disease and did not improve after publication of the CONSORT-NPT-2017 update with abstract guidance.

Transparency and reporting characteristics of COVID-19 randomized controlled trials

BackgroundIn the context of the COVID-19 pandemic, randomized controlled trials (RCTs) are essential to support clinical decision-making. We aimed (1) to assess and compare the reporting characteristics of RCTs between preprints and peer-reviewed publications and (2) to assess whether reporting improves after the peer review process for all preprints subsequently published in peer-reviewed journals.MethodsWe searched the Cochrane COVID-19 Study Register and L·OVE COVID-19 platform to identify all reports of RCTs assessing pharmacological treatments of COVID-19, up to May 2021. We extracted indicators of transparency (e.g., trial registration, data sharing intentions) and assessed the completeness of reporting (i.e., some important CONSORT items, conflict of interest, ethical approval) using a standardized data extraction form. We also identified paired reports published in preprint and peer-reviewed publications.ResultsWe identified 251 trial reports: 121 (48%) were first published in peer-reviewed journals, and 130 (52%) were first published as preprints. Transparency was poor. About half of trials were prospectively registered (n = 140, 56%); 38% (n = 95) made their full protocols available, and 29% (n = 72) provided access to their statistical analysis plan report. A data sharing statement was reported in 68% (n = 170) of the reports of which 91% stated their willingness to share. Completeness of reporting was low: only 32% (n = 81) of trials completely defined the pre-specified primary outcome measures; 57% (n = 143) reported the process of allocation concealment. Overall, 51% (n = 127) adequately reported the results for the primary outcomes while only 14% (n = 36) of trials adequately described harms. Primary outcome(s) reported in trial registries and published reports were inconsistent in 49% (n = 104) of trials; of them, only 15% (n = 16) disclosed outcome switching in the report. There were no major differences between preprints and peer-reviewed publications. Of the 130 RCTs published as preprints, 78 were subsequently published in a peer-reviewed journal. There was no major improvement after the journal peer review process for most items.ConclusionsTransparency, completeness, and consistency of reporting of COVID-19 clinical trials were insufficient both in preprints and peer-reviewed publications. A comparison of paired reports published in preprint and peer-reviewed publication did not indicate major improvement.

Assessment of transparency and selective reporting of interventional trials studying colorectal cancer

BackgroundColorectal cancer (CRC) is currently one of the most frequently diagnosed cancers. Our aim was to evaluate transparency and selective reporting in interventional trials studying CRC.MethodsFirst, we assessed indicators of transparency with completeness of reporting, according to the CONSORT statement, and data sharing. We evaluated a selection of reporting items for a sample of randomized controlled trials (RCTs) studying CRC with published full-text articles between 2021–03-22 and 2018–03-22. Selected items were issued from the previously published CONSORT based peer-review tool (COBPeer tool). Then, we evaluated selective reporting through retrospective registration and primary outcome(s) switching between registration and publication. Finally, we determined if primary outcome(s) switching favored significant outcomes.ResultsWe evaluated 101 RCTs with published full-text articles between 2021–03-22 and 2018–03-22. Five trials (5%) reported all selected CONSORT items completely. Seventy-four (73%), 53 (52%) and 13 (13%) trials reported the primary outcome(s), the allocation concealment process and harms completely. Twenty-five (25%) trials were willing to share data. In our sample, 49 (49%) trials were retrospectively registered and 23 (23%) trials had primary outcome(s) switching. The influence of primary outcome(s) switching could be evaluated in 16 (16/23 = 70%) trials, with 6 (6/16 = 38%) trials showing a discrepancy that favored statistically significant results.ConclusionsOur results highlight a lack of transparency as well as frequent selective reporting in interventional trials studying CRC.

Unusual Findings in Trials Evaluating Adjuncts to Scaling and Root Planing: Reporting Quality (Part 2).

On the topic of adjuncts to scaling and root planing (SRP), numerous randomized clinical trials (RCTs) were published by a single group of authors and frequently reported unusually large effect sizes. A meta-analysis in part 1 of this project failed to explain the causes for these unusual findings. We assessed the reporting quality and trial registration discrepancies to examine the possibility of replicating the work of this research group as well as the overall rigor of the research methodology. This study was preregistered at the Open Science Framework (https://osf.io/4meyd/). The Scopus platform was utilized for the RCT search on SRP adjuncts in intrabony defects in patients with periodontitis as compared with SRP alone. The search analysis was limited from 2010 to 2017, and RCTs on SRP adjuncts published by a single research group were selected for screening and inclusion. RCT registration records were assessed for consistency. Out of 92 studies that were retrieved from Scopus and PubMed, 32 were included for quality assessment per the CONSORT guidelines (Consolidated Standards of Reporting Trials). Results showed that all RCTs were characterized by a low reporting quality. The majority of CONSORT items scored <50%, including critical items (randomization, registration, and blinding). When registration records were compared with published RCTs, several discrepancies were found. The per-protocol follow-up duration was compared against the study's initiation and termination dates. Only 38% of the RCTs presented a follow-up period within the initiation and termination dates. The remaining RCTs showed inconsistent follow-up in comparison with the initiation and termination dates. RCTs by this group were characterized by poor adherence to reporting quality guidelines. Crucial RCT elements, such as randomization, blinding, and primary outcomes, were not reported properly. RCT registration records revealed systematic inconsistencies when compared with RCT publication. Therefore, the unusually large effects reported by this group should be viewed with extreme caution. The included randomized clinical trials were characterized by poor adherence to reporting quality guidelines, missing information about important trial items, and discrepancies between the reports and trial registrations. This quality assessment should guide clinical research and show clinicians that they should be cautious when applying evidence in their clinical practice.

Assessment of Randomized Clinical Trials articles in Medical Journal of Mashhad University of Medical Sciences based on CONSORT statement

Introduction: Clinical studies have a special value among a variety of studies. The results of these studies have important applications on human populations, including the study of the effects of drugs and therapies. Given the importance of such studies, it seems necessary to review the quality and evaluation of articles related to this field of research. The issue of critical appraisal has a very important place in biomedical studies; And help researchers evaluate the quality of articles. The aim of this study was to evaluate the articles Medical Journal of Mashhad University of Medical Sciences during 1388-1398. Method: The present study was a descriptive cross-sectional study .In this study, the study population was 173 articles that were selected from 741 articles published in the Journal of the Faculty of Medicine of Mashhad University of Medical Sciences during 1388 to the end of 1398. These articles were reviewed using consort checklists in 25 general items by two statistical experts with an agreement of more than 0.91%. Data were analyzed by SPSS software version 23. Findings: In evaluating the articles in this journal, a growing trend was observed in the number of articles published in the review. According to the evaluations based on the Consort Checklist, the lowest score assigned to articles was 6 points, which was related to an article in 1394, and the highest was an article in 1397, which received a score of 27 out of 37. The average score of all articles was 13.53 with a standard deviation of 2.82. The statistical methods used and the mention of the term clinical trial in the title were the items that received the most and the least amount of attention in the research, respectively. Conclusion: In general, the attention of the studied articles to the observance of the points of the consort statement has been less than acceptable, which eliminates the shortcomings and observes more of the consort items to increase the quality of the articles in Medical Journal of Mashhad University of Medical Sciences.

A multiyear systematic survey of the quality of reporting for randomised trials in dentistry, neurology and geriatrics published in journals of Spain and Latin America

BackgroundThe Iberoamerican Cochrane Network is currently developing an extensive project to identify Spanish-language journals that publish original clinical research in Spain and Latin America. The project is called BADERI (Database of Iberoamerican Essays and Journal) and feeds the research articles, mainly randomised clinical trials (RCTs), into CENTRAL (Cochrane Collaboration Central Register of Controlled Trials). This study aims to assess the quality of reporting of RCTs published in Spanish and Latin American journals for three clinical fields and assess changes over time.MethodsWe did a systematic survey with time trend analysis of RCTs for dentistry, geriatrics, and neurology. These fields were chosen for pragmatic reasons as they had not yet been completed in BADERI. After screening RCTs from 1990 to 2018 for randomised or quasi-randomised clinical trials, we extracted data for 23 CONSORT items. The primary outcome was the total score of the 23 predefined CONSORT 2010 items for each RCT (score range from 0 to 34). The secondary outcome measure was the score for each one of these 23 items.ResultsA total of 392 articles from 1990 to 2018 were included as follows: dentistry (282), neurology (80), and geriatrics (30). We found that the overall compliance score for the CONSORT items included in this study for all 392 RCTs analysed was 12.6 on a scale with a maximum score of 34. With time, the quality of reporting improved slightly for all RCTs. None of the articles achieved the complete individual CONSORT item compliance score. The lowest overall compliance percentage was for item 10 (Randomisation implementation) and item 24 (Protocol registration), with a dismal 1% compliance across all included RCTs, regardless of country.ConclusionsCONSORT compliance is very poor in the 392 analysed RCTs. The impact of the CONSORT statement on improving the completeness of RCT reporting in Latin America and Spain is not clear. Iberoamerican journals should become more involved in endorsing and enforcing adherence to the CONSORT guidelines.

Toward assessing clinical trial publications for reporting transparency

ObjectiveTo annotate a corpus of randomized controlled trial (RCT) publications with the checklist items of CONSORT reporting guidelines and using the corpus to develop text mining methods for RCT appraisal. MethodsWe annotated a corpus of 50 RCT articles at the sentence level using 37 fine-grained CONSORT checklist items. A subset (31 articles) was double-annotated and adjudicated, while 19 were annotated by a single annotator and reconciled by another. We calculated inter-annotator agreement at the article and section level using MASI (Measuring Agreement on Set-Valued Items) and at the CONSORT item level using Krippendorff’s α. We experimented with two rule-based methods (phrase-based and section header-based) and two supervised learning approaches (support vector machine and BioBERT-based neural network classifiers), for recognizing 17 methodology-related items in the RCT Methods sections. ResultsWe created CONSORT-TM consisting of 10,709 sentences, 4,845 (45%) of which were annotated with 5,246 labels. A median of 28 CONSORT items (out of possible 37) were annotated per article. Agreement was moderate at the article and section levels (average MASI: 0.60 and 0.64, respectively). Agreement varied considerably among individual checklist items (Krippendorff’s α= 0.06–0.96). The model based on BioBERT performed best overall for recognizing methodology-related items (micro-precision: 0.82, micro-recall: 0.63, micro-F1: 0.71). Combining models using majority vote and label aggregation further improved precision and recall, respectively. ConclusionOur annotated corpus, CONSORT-TM, contains more fine-grained information than earlier RCT corpora. Low frequency of some CONSORT items made it difficult to train effective text mining models to recognize them. For the items commonly reported, CONSORT-TM can serve as a testbed for text mining methods that assess RCT transparency, rigor, and reliability, and support methods for peer review and authoring assistance. Minor modifications to the annotation scheme and a larger corpus could facilitate improved text mining models. CONSORT-TM is publicly available at https://github.com/kilicogluh/CONSORT-TM.

Describing deprescribing trials better: an elaboration of the CONSORT statement

ObjectiveThe objective of this study was to identify key features to be addressed in the reporting of deprescribing trials and to elaborate and explain CONSORT items in this regard. Study Design and SettingAs a first step in a multistage process and based on a systematic review of deprescribing trials, we elaborated variation in design, intervention, and reporting of the included trials of the review. We identified items that were missed or insufficiently described, using the CONSORT and TIDieR checklists. The resulting list of items, which we considered relevant to be reported in deprescribing trials, were discussed in a single-round Delphi exercise and subsequently in a full-day face-to-face meeting with an international panel of 14 experts. We agreed on CONSORT items for further elaboration with regard to design and reporting of deprescribing trials. ResultsWe identified seven CONSORT items on trial design, participants, intervention, outcomes, flowchart, and harms, where the investigators of deprescribing trials should take into consideration specific aspects, such as whether or not to use placebo or how to inform participants. ConclusionThis article presents an elaboration to the CONSORT statement for the reporting of deprescribing trials. It may also support investigators in motivated design choices.

Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist

BackgroundA considerable amount of randomized controlled trials (RCTs) have been published on statins and/or fibrates for diabetic retinopathy, a clinical condition associated with high social and economic burden. Adherence to the CONSORT statement items is imperative to ensure transparency and reproducibility in clinical research. The aim of this study is to assess the reporting quality and the adherence to CONSORT of RCTs assessing statins and/or fibrates for diabetic retinopathy.MethodsWe conducted a critical appraisal study at Discipline of Evidence-based Medicine, Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). A sensitive literature search was performed to identify all relevant RCTs, with no time or language limits. Two authors independently evaluated the reporting quality of the selected RCTs using the CONSORT statement as a standard.ResultsThirteen reports of RCTs were included in this study. The adherence of the reports to CONSORT items ranged from 24% to 68%. The median score was 11 (interquartile range (IQR) 8 to 13). When analyzed separately, the methods sections of the reports had a median of three items (IQR 2 to 4) judged adherent to the methods items of CONSORT (items 3 to 12). The most underreported items were those related to trial design, title and abstract, allocation concealment, implementation of the randomization sequence, and blinding. Other important items, such as the one related to the description of the inclusion criteria, also had low adherence.ConclusionsThe overall adherence to the CONSORT checklist items was poor, especially in the items related to the methods section. RCT reports on statins and/or fibrates for diabetic retinopathy must be optimized to avoid reporting biases and to improve transparency and reproducibility.

Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study

BackgroundThe peer review process has been questioned as it may fail to allow the publication of high-quality articles. This study aimed to evaluate the accuracy in identifying inadequate reporting in RCT reports by early career researchers (ECRs) using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process.MethodsWe performed a cross-sectional diagnostic study of 119 manuscripts, from BMC series medical journals, BMJ, BMJ Open, and Annals of Emergency Medicine reporting the results of two-arm parallel-group RCTs. One hundred and nineteen ECRs who had never reviewed an RCT manuscript were recruited from December 2017 to January 2018. Each ECR assessed one manuscript. To assess accuracy in identifying inadequate reporting, we used two tests: (1) ECRs assessing a manuscript using the COBPeer tool (after completing an online training module) and (2) the usual peer-review process. The reference standard was the assessment of the manuscript by two systematic reviewers. Inadequate reporting was defined as incomplete reporting or a switch in primary outcome and considered nine domains: the eight most important CONSORT domains and a switch in primary outcome(s). The primary outcome was the mean number of domains accurately classified (scale from 0 to 9).ResultsThe mean (SD) number of domains (0 to 9) accurately classified per manuscript was 6.39 (1.49) for ECRs using COBPeer versus 5.03 (1.84) for the journal’s usual peer-review process, with a mean difference [95% CI] of 1.36 [0.88–1.84] (p < 0.001). Concerning secondary outcomes, the sensitivity of ECRs using COBPeer versus the usual peer-review process in detecting incompletely reported CONSORT items was 86% [95% CI 82–89] versus 20% [16–24] and in identifying a switch in primary outcome 61% [44–77] versus 11% [3–26]. The specificity of ECRs using COBPeer versus the usual process to detect incompletely reported CONSORT domains was 61% [57–65] versus 77% [74–81] and to identify a switch in primary outcome 77% [67–86] versus 98% [92–100].ConclusionsTrained ECRs using the COBPeer tool were more likely to detect inadequate reporting in RCTs than the usual peer review processes used by journals. Implementing a two-step peer-review process could help improve the quality of reporting.Trial registrationClinical.Trials.govNCT03119376 (Registered April, 18, 2017).

Do randomised controlled trials relevant to pharmacy meet best practice standards for quality conduct and reporting? A systematic review.

Evidence-based pharmacy practice requires a dependable evidence base. Randomised controlled trials (RCTs) are the gold standard of high-quality primary research, and tools exist to assist researchers in conducting and reporting high-quality RCTs. This review aimed to explore whether RCTs relevant to pharmacy are conducted and reported in line with Cochrane risk of bias and CONSORT standards, respectively. A MEDLINE search identified potential papers. After screening of titles, abstracts and full texts, the 50 most recent papers were reviewed and assessment of bias according to Cochrane domains and compliance with CONSORT checklist items was recorded. Each domain of the Cochrane tool and CONSORT checklist item and each article were given a percentage score, reported as median and interquartile range (IQR). Correlation between quality of conduct, quality of reporting, continent of origin, and journal impact factor was conducted using the R2 statistic. The median domain score for risk of bias by paper according to the Cochrane risk of bias tool was 53.0% (IQR 38.5-68.5), while the median compliance score by paper for the CONSORT checklist was 64.0% (IQR 36.0-94.0%). The median Cochrane domain and median CONSORT item completion scores, respectively, were 50.0% (IQR 33.3-66.7%) and 59.5% (IQR 52.0-70.3%). The highest risk of bias was associated with allocation concealment and blinding, and the least well-reported items were randomisation details, sequence generation and allocation concealment. A positive relationship between conduct and reporting of RCTs was found (R2 =0.75), while no correlation was found between quality of conduct or quality of reporting and journal impact factor, correlation coefficients (R2 =0.06 and R2 =0.05, respectively). This review identified that issues related to randomisation and blinding are often inadequately conducted or not comprehensively reported by researchers conducting pharmacy relevant RCTs, providing useful information for education and future research.

Randomized Controlled Trials on Intracerebral Hemorrhage: A Cross Sectional Retrospective Analysis of CONSORT Item Adherence

Object: Intracranial hemorrhage (ICH) is the second most common cause of stroke but still there is little consolidated knowledge about the optimal treatment strategies (e.g., the benefit of surgical evacuation). We evaluated the current randomized controlled trials (RCTs) on primary ICH (01.2013–03.2017) according to their fulfillment of the CONSORT statement's criteria (published in 2010) –as a marker of transparency and quality of study planning and realization.Methods: A Pubmed and a Cochrane database (including clinicaltrials.gov) search was carried out (01.2014–3.2017, respectively 01.2013–12.2013). s were screened for inclusion. Eligible full text manuscripts were assessed for the implementation of the CONSORT criteria. Citation frequencies and impact factors of the journals were related to ratio of CONSORT criteria fulfillment. Further, the risk of bias according to the Risk of bias tool 2 (RoB 2) was assessed.Results: Overall 3097 abstracts were screened for inclusion; 39 studies were suitable for final analysis. A mean fulfillment ratio of 51% (±28%) was found. A high correlation between impact factor and adherence to CONSORT criteria was shown (r = 0.7664; p < 0.0001). Citation frequency per year was related to ratio of CONSORT item fulfillment (r = 0.6747; p < 0.0001) and to the impact factor of the publishing journal (r = 0.7310; p < 0.0001). Of note, the items 10 (randomization: implementation) and 21 (generalizability) showed particularly high rates of non-fulfillment (87 and 85%). The majority of studies (95%) complied with item 2b (specific objectives or hypotheses), but strikingly objectives were mostly described vaguely. Other essential criteria such as sample size determination, definition of outcome parameters, and participant flow were only fulfilled weakly (51, 54, and 39%).Conclusions: Over 20 years after its inception there is still weak adherence to the CONSORT statement. As a consequence, conclusions are hampered by inadequate planning and/or reporting. Particularly with respect to pathologies as ICH lacking clear, evidence-based guidelines adherence to the CONSORT statement might improve research quality in order to define valuable treatment strategies.

Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement.

Randomized controlled trials (RCTs) are the cornerstone of evidence based medicine. Ιt is crucial that RCTs have transparent reporting to facilitate their interpretation. Thepurpose of the present study is the evaluation of the reporting quality of RCTs for novel oral anticoagulants (NOACs) in venous thromboembolism (VTE) based on the CONSORT statement. MEDLINE was meticulously searched, while quoted references by retrieved RCTs were manually screened. The primary objective was to establish the mean CONSORT compliance of RCTs for NOACs in VTE. Secondary objectives were the calculation of compliance per CONSORT item and the investigation for probable determining factors with regards to the reporting quality of RCTs. Reporting above 70% of the items was defined as adequate compliance to the CONSORT statement. A total of 83 articles were considered eligible. Mean adherence to the CONSORT statement was 61.84%, standard deviation (SD) = 18.72. Among retrieved studies, 35 (42.17%) reported above 70% of the items, while 48 (57.83%) described less than 70% of the items. Inter-rater agreement was satisfactory (Cohen's kappa ≥ 0.75). Items with respect to randomization and blinding were principally underreported, whereas the rest of the methodological features and results were more sufficiently reported. Logistic regression failed to demonstrate significant effect for any of the factors investigated. Impact factor [odds ratio (OR) = 1.347, 95% confidence interval (CI) (0.994, 1.826), p = 0.055], number of authors [OR = 1.277, 95% CI (0.975, 1.672), p = 0.076] and presentation of participant flow-diagram [OR = 55.358, 95% CI (0.914, 3351.765), p = 0.055], came closer to significance. Exploratory analysis revealed significant, strong, positive correlation between abstract and article adherence to the CONSORT guidelines (r = 0.851, p < 0.001). Reporting quality of RCTs for NOACs in VTE is moderate. A superior reporting quality is desirable, especially relating to randomization and blinding.

Do Clinical Trial Publications in AMD Healthcare Provide Sufficient Information on the Underlying Samples' Baseline Characteristics to Enable Generalizability Considerations on the Trial Design?

Results of RCTs must enable readers to assess applicability of the presented information into clinical routine. Therefore, the CONSORT statement's item 15 recommends explicit information on (baseline) characteristics for RCT samples. We sought to quantify the adherence to this CONSORT item by evaluation of RCTs on "age-related macular degeneration" (AMD). A full survey comprised of 132 RCTs (01/2004 - 12/2013). Two parallel independent readers evaluated, and then consented, whether baseline characteristics as recommended were provided in the publication, and whether this information was formally and correctly presented. The evaluation was performed hierarchically in accordance to the sub-criteria of the CONSORT-statement. In the case of formally correct documentation, characteristics for age, gender, the primary clinical endpoint outcome, and the stage of AMD were checked, as well as for systemic or ophthalmological pre-existing conditions. 129 of 132 (98%) publications provided the documentation of baseline data, but only 67 (51%) showed a correct implementation. 77 (58%) RCT reports presented baseline data at study initiation, among which n = 67 (87%) publications presented the data stratified for samples. The implementation rate of the CONSORT criterion "baseline data" in publications appeared high. On closer inspection, publications often provided incomplete or even misleading baseline data. As a consequence, everybody in the publication process should be aware of the conditions for publishing.

The Methodological Quality of an Article of Treatment on Early Ductal Decompression Versus Conservative Treatment for Gallstone Pancreatitis with Ampullary Obstruction

Early ductal decompression in the treatment of acute biliary pancreatitis with ampullary obstruction is controversial. The objective of this study is to determine the methodological quality, internal and external validity of the article of Acosta et al. (2006), that compares the effectiveness of early ductal decompression versus conservative management in acute biliary pancreatitis with ampullary obstruction. Acosta et al., article was subjected to a therapy User’s Guide. Subsequently its methodological quality was analyzed applying 3 instruments; MINCIR therapy, CONSORT and SIGN. The application of these instruments was performed independently by four researchers, trained in critical analysis of the literature and clinical epidemiology. The article is not oriented to a definite question. It has a random assignment of participants, but these were not properly considered until the end of the study. It has 16 points of MINCIR scale (cut-off of the methodological quality construct is 18). Fulfills with only 10 of the 21 items of CONSORT. All the instruments used put in evidence similar methodological weaknesses that lead to questioning of the internal and external validity of the study, a fact that in turn makes questioning the logic of the applicability of this protocol.

Methodological Quality of an Article for Treatment in Early Ductal Decompression versus Conservative Treatment in Gallstone Pancreatitis with Ampullary Obstruction

Early ductal decompression in the treatment of acute biliary pancreatitis with ampullary obstruction is controversial. The objective of this study is to determine the methodological quality, internal and external validity of the article of Acosta et al. (2006), which compares the effectiveness of early ductal decompression versus conservative management in acute biliary pancreatitis with ampullary obstruction. Acosta et al. (2006), article was subjected to a therapy User’s Guide. Subsequently its methodological quality was analyzed applying 3 instruments; MINCIR therapy, CONSORT and SIGN. The application of these instruments was performed independently by four researchers, trained in critical analysis of the literature and clinical epidemiology. The article is not oriented to a definite question. It has a random assignment of participants, but these were not properly considered until the end of the study. It has 16 points of MINCIR scale (cut-off of the methodological quality construct is 18). It complies with only 10 of the 21 items of CONSORT. All instruments used put into evidence similar methodological weaknesses that lead to questioning of the internal and external validity of the study, a fact that in turn questions the logic of the applicability of this protocol.

Comparison of the Quality of Pediatric Randomized Controlled Trials Published in Both Nursing and Medical Journals: Adherence to the CONSORT Statement

Nursing care should be based on scientific evidence. However, studies must be performed rigorously with accurate reporting for their findings to be applicable to practice. Since the body of scientific nursing literature is broad, the quality and validity of its findings should be regularly controlled and verified to ensure their application and their practical impact. To compare reporting quality of pediatric randomized controlled trial (RCT) articles in nursing and medical journals. Randomly selected articles were reviewed and scored to assess the number of CONSORT items that were adequately reported, generating a CONSORT score. The CONSORT scores for 28 items were compared between the two journal types. The CONSORT scores by journal type were not significantly different: (19.2 [16.2; 22] for medical journals and 19.5 [16.1; 21.5] for nursing journals, p=.77). The reporting of CONSORT items was poor for both journal types. However, there were two significant differences: item 19 (Declaration of all important harm or unintended effects, p=.0006) and item 23 (Registration number of the study, p=.0003), were reported more often in medical journals. The adherence of journals to the CONSORT statement and large sample size was associated with better quality of the reporting of studies. Based on reporting quality, nursing studies have the same scientific credibility and rigor as medical studies in the pediatric field. The findings of this study could help researchers improve the reporting of their studies and highlight the importance of reporting quality for future knowledge transfer and practical use. The quality of research and its reporting is necessary to improve knowledge transfer into practice.

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

BackgroundInadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving.MethodsWe aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting, provider, recipient, comparator, intervention intensity, how it was conducted, existence of a manual or protocol, and detail of whether there was an assessment of fidelity). Score per item was ‘1’ if reported adequately and ‘0’ if not.ResultsOf the eligible trials, 42 were published in Time-1 and 134 published in Time-2. The trials included were published in 112 peer-reviewed journals, 52 of these journals currently require authors to follow the CONSORT Statements, while only one recommended adherence to the TIDieR.Most items of CONSORT and TIDieR were reported by more than half of the trials at both time points. Few trials reported fidelity. A large proportion of the trials did not report the existence of a manual or protocol, or what the comparator group received. We found no statistically significant improvement in the eight-item quality score (Time-1: mean 5.71 (standard deviation (SD) 1.09), Time-2: 5.87 (SD 1.28), p = 0.49).ConclusionsWe found no overall evidence that reporting the specifics of multicomponent, non-pharmacological interventions is improving. Details to replicate interventions remain lacking, impairing best implementation or meaningful further research. Editorial endorsement of reporting checklists needs to be more extensive.