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

ABSTRACT: BACKGROUND:A 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. METHODS:We 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. RESULTS:Thirteen 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. CONCLUSIONS:The 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.

SUBMITTER: Mozetic V

PROVIDER: S-EPMC6916100 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

Mozetic Vânia V Leonel Letícia L Leite Pacheco Rafael R de Oliveira Cruz Latorraca Carolina C Guimarães Taís T Logullo Patricia P Riera Rachel R

Trials 20191216 1

<h4>Background</h4>A 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.<h4> ...[more]

PMID: 31842982

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Project description:Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n?=?4), statins (n?=?3) and fibrate plus statins (n?=?1) for therapy (n?=?8) or prevention (n?=?4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2?=?0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746.

Project description:BackgroundRandomised Controlled Trials (RCTs) are the preferred study design when comparing therapeutical interventions in medicine. To improve clarity, consistency and transparency of reporting RCTs, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed.Objectives(1) To assess the quality of reports and abstracts of RCTs in otorhinolaryngologic literature by using CONSORT checklists, (2) to compare the quality of reports and abstracts of otorhinolaryngologic RCTs between the top 5 general medical journals and top 5 otorhinolaryngologic journals, and (3) to formulate recommendations for authors and editors of otorhinolaryngologic ('ENT') journals.MethodsBased on 2012 ISI Web of Knowledge impact factors, the top 5 general medical and ENT journals were selected. On 25 June 2014, using a highly sensitive Cochrane RCT filter and ENT filter, possibly relevant articles since January 1st, 2010 were retrieved and relevant RCTs were selected. We assessed how many CONSORT items were reported adequately in reports and abstracts and compared the two journal types.ResultsOtorhinolaryngologic RCTs (n = 15) published in general medical journals reported a mean of 92.1% (95% confidence interval: 89.5%-94.7%) of CONSORT items adequately, whereas RCTs (n = 18) published in ENT journals reported a mean of 71.8% (66.7%-76.8%) adequately (p < 0.001). For abstracts, means of 70.0% (63.7%-76.3%) and 32.3% (26.6-38.0%) were found respectively (p < 0.001). Large differences for specific items exist between the two journal types.ConclusionThe quality of reporting of RCTs in otorhinolaryngologic journals is suboptimal. RCTs published in general medical journals have a higher quality of reporting than RCTs published in ENT journals. We recommend authors to report their trial according to the CONSORT Statement and advise editors to endorse the CONSORT Statement and implement the CONSORT Statement in the editorial process to ensure more adequate reporting of RCTs and their abstracts.

Project description:ImportanceAdherence to the Consolidated Standards of Reporting Trials (CONSORT) for randomized clinical trials is associated with improvingquality because inadequate reporting in randomized clinical trials may complicate the interpretation and the application of findings to clinical care.ObjectiveTo evaluate an automated reporting checklist generation tool that uses natural language processing (NLP), called CONSORT-NLP.Design, setting, and participantsThis study used published journal articles as training, testing, and validation sets to develop, refine, and evaluate the CONSORT-NLP tool. Articles reporting randomized clinical trials were selected from 25 high-impact-factor journals under the following categories: (1) general and internal medicine, (2) oncology, and (3) cardiac and cardiovascular systems.Main outcomes and measuresFor an evaluation of the performance of this tool, an accuracy metric defined as the number of correct assessments divided by all assessments was calculated.ResultsThe CONSORT-NLP tool uses the widely used Portable Document Format as an input file. Of the 37 CONSORT reporting items, 34 (92%) were included in the tool. Of these 34 reporting items, 30 were fully implemented; 28 (93%) of the fully implemented CONSORT reporting items had an accuracy of more than 90% for the validation set. The remaining 2 (7%) had an accuracy between 80% and 90% for the validation set. Two to 5 articles were selected from each of these journals for a total of 158 articles to establish a training set of 111 articles to train CONSORT-NLP for CONSORT reporting items, a testing set of 25 articles to refine CONSORT-NLP, and a validation set of 22 articles to assess the performance of CONSORT-NLP. The CONSORT-NLP tool used the Portable Document Format of the articles as input files. A CONSORT-NLP graphical user interface was built using Java in 2019. The time required to complete the CONSORT checklist manually vs using the CONSORT-NLP tool was compared for 30 articles. Two case studies for randomized clinical trials are provided as an illustration for the CONSORT-NLP tool. For the 30 articles investigated, CONSORT-NLP required a mean (SD) 23.0 (4.1) seconds, whereas the manual reviewer required a mean (SD) 11.9 (2.2), 22.6 (4.6), and 57.6 (7.1) minutes, for 3 reviewers, respectively.Conclusions and relevanceThe CONSORT-NLP tool is designed to assist in the reporting of randomized clinical trials. Potential users of CONSORT-NLP include clinicians, researchers, and scientists who plan to publish a randomized trial study in a peer-reviewed journal. The use of CONSORT-NLP may help them save substantial time when generating the CONSORT checklist. This tool may also be useful for manuscript reviewers and journal editors who review these articles.

Project description:BACKGROUND:Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite the availability of pharmacologic treatment options such as opioids, many patients continue to experience persistent pain. Cannabinoids present an alternative option with some data on efficacy; however, to date, a systematic review of adverse events (AEs) assessment and reporting in randomized clinical trials (RCTs) involving cannabinoids has not been performed. As a result, it is unclear whether a clear profile of cannabinoid-associated AEs has been accurately detailed in the literature. As cannabinoids are likely to become readily available for patients in the near future, it is important to study how well AEs have been reported in trials so that the safety profile of cannabinoids can be better understood. OBJECTIVE:With a potentially enormous shift toward cannabinoid use for managing chronic pain and spasticity, this study aims to reveal the adequacy of AE reporting and cannabinoid-specific AEs in this setting. Spasticity is a major contributor to chronic pain in patients with multiple sclerosis (MS), with a comorbidity of 75%. Many cannabinoid studies have been performed in MS-related painful spasticity with relevant pain outcomes, and these studies will be included in this review for comprehensiveness. The primary outcome will be the quality of AE assessment and reporting by adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Secondary outcomes will include the type of AE, method of AE reporting, severity of AE, frequency of AEs, patient withdrawals, and reasons for withdrawals. METHODS:We will perform a systematic review by searching for primary reports of double-blind, randomized controlled trials of cannabinoids compared with placebo and any active comparator treatments for chronic pain, with a primary outcome directly related to pain (eg, pain intensity, pain relief, and pain-related interference). We will search the following databases: MEDLINE, Embase, Cochrane Library, and PsycINFO. RevMan software will be used for meta-analysis. RESULTS:The protocol has been registered on the International Prospective Register of Systematic Reviews (CRD42018100401). The project was funded in 2018 and screening has been completed. Data extraction is under way and the first results are expected to be submitted for publication in January or February 2019. CONCLUSIONS:This review will better elucidate the safety of cannabinoids for the treatment of chronic pain and spasticity through identifying gaps in the literature for AE reporting. Like in any new therapy, it is essential that accurate information surrounding the safety and efficacy of cannabinoids be clearly outlined and identified to balance the benefit and harm described for patients. TRIAL REGISTRATION:PROSPERO CRD42018100401; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=100401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11637.

Dataset Information

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

Publications

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

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