Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)—a review

Background In 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects underwent fast-track peer review procedures and were published in freely accessible formats. Although full texts about COVID-19 are currently available for free, abstracts continue to play a key role since they provide essential information and possibly a decision basis for therapies. Abstracts are particularly important in case the full texts are not free, not all reports have been published in English and in emergency situations when there is less time for comprehensive analysis of all full texts. It is therefore necessary to ensure that abstracts—as publications in miniature format—contain comprehensive and transparent information. The CONSORT statement for abstracts (CONSORT-A) offers guidelines to authors how to include all necessary information in an abstract. Prior to the COVID-19 pandemic, the quality of reporting in medical research had already been the object of debate and criticism. The current crisis makes comprehensive documentation all the more important. Abstracts of COVID-19 RCTs should therefore report the criteria listed in the CONSORT-A statement fully and verifiably. The objective of this study is to check the completeness of abstracts of all COVID-19 RTCs published to date. Methods Based on a literature search in PubMed, Embase and the Cochrane Library, all publications up to 29 October 2020 are identified and examined in terms of the subject matter (reported results from COVID-19 studies) and their study design (RTC). Subsequently, suitable publications are examined for completeness and quality of abstracts. The CONSORT checklist for RTC abstracts serves as a basis in this procedure. The primary endpoint of the study is the percentage of correctly implemented items of the CONSORT statement for abstracts. The frequency of correct reporting of each individual item is checked in a second step. Discussion The study is expected to contribute to evaluating the reporting quality on COVID-19 studies, and specifically the completeness of abstracts of RTCs. It may thus support the assessment of current research into COVID-19. Trial registration Registration was not required as the study investigated existing literature.

Effect of Crocus sativus (Saffron) Intake on Top of Standard Treatment, on Disease Outcomes and Comorbidities in Patients with Rheumatic Diseases: Synthesis without Meta-Analysis (SWiM) and Level of Adherence to the CONSORT Statement for Randomized Controlled Trials Delivering Herbal Medicine Interventions

Rheumatic diseases (RDs) are often complicated by chronic symptoms and frequent side-effects associated with their treatment. Saffron, a spice derived from the Crocus sativus L. flower, is a popular complementary and alternative medicine among patients with RDs. The present systematic review aimed to summarize the available evidence regarding the efficacy of supplementation with saffron on disease outcomes and comorbidities in patients with RD diagnoses. PubMed, CENTRAL, clinicaltrials.gov and the grey literature were searched until October 2021, and relevant randomized controlled trials (RCTs) were screened for eligibility using Rayyan. Risk of bias was assessed using the Cochrane’s Risk of Bias-2.0 (RoB) tool. A synthesis without meta-analysis (SWiM) was performed by vote counting and an effect direction plot was created. Out of 125 reports, seven fulfilled the eligibility criteria belonging to five RCTs and were included in the SWiM. The RCTs involved patients with rheumatoid arthritis, osteoarthritis and fibromyalgia, and evaluated outcomes related to pain, disease activity, depression, immune response, inflammation, oxidative stress, health, fatigue and functional ability. The majority of trials demonstrated some concerns regarding overall bias. Moreover, the majority of trialists failed to adhere to the formula elaborations suggested by the CONSORT statement for RCTs incorporating herbal medicine interventions. Standardization of herbal medicine confirms its identity, purity and quality; however, the majority of trials failed to adhere to these guidelines. Due to the great heterogeneity and the lack of important information regarding the standardization and content of herbal interventions, it appears that the evidence is not enough to secure a direction of effect for any of the examined outcomes.

Evaluation of reporting quality of randomized controlled trials in patients with COVID-19 using the CONSORT statement

Objective To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors. Methods PubMed, Embase, Web of Science and the Cochrane Library databases were searched to collect RCTs regarding patients with COVID-19. The retrieval time was from the inception to December 1, 2020. The CONSORT 2010 statement was used to evaluate the overall reporting quality of these RCTs. Results 53 RCTs were included. The study showed that the average reporting rate for 37 items in CONSORT checklist was 53.85% with mean overall adherence score of 13.02±3.546 (ranged: 7 to 22). The multivariate linear regression analysis showed the overall adherence score to the CONSORT guideline was associated with journal impact factor (P = 0.006), and endorsement of CONSORT statement (P = 0.014). Conclusion Although many RCTs of COVID-19 have been published in different journals, the overall reporting quality of these articles was suboptimal, it can not provide valid evidence for clinical decision-making and systematic reviews. Therefore, more journals should endorse the CONSORT statement, authors should strictly follow the relevant provisions of the CONSORT guideline when reporting articles. Future RCTs should particularly focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size.

Compliance of RCTs in endodontic instrumentation with the CONSORT Statement: A systematic review

This systematic review aimed to evaluate the adherence to the CONSORT Statement in clinical studies comparing different instrumentation techniques in Endodontics. Methodology: A systematic search was carried out through Medline databases. There was no restriction on publication year or idiom. Solely randomized controlled trials (RCTs) were included. The articles were evaluated in compliance with CONSORT. Descriptive analyses of the number of studies by journal, country, and quality assessments were performed with RoB 2.0 Cochrane Collaboration’s tool for assessing risk of bias in RCTs. A total of 6779 studies were identified, and only 33 meet the eligibility criteria. In relation to the overall risk of bias, eight out of 33 were classified as at ‘low’ risk of bias. The overall CONSORT score for the included studies in this review was 22 ± 6.2 points. Significant differences among countries were observed (p = 0.03). The range of years had a significant influence on the average CONSORT score (p = 0.01). The adherence of RCTs of endodontic instrumentation to the CONSORT Statement requires improvements. Adherence to the CONSORT statement will also reduce the high or some concerns risk of bias of studies in the field. CRD42020160552

Quality Evaluation of Randomized Controlled Trials of Rhodiola Species: A Systematic Review

Background. Rhodiola is a worldwide used medicinal plant for its various medicinal functions, and the number of randomized controlled trials (RCTs) of Rhodiola is increasing in recent years. This study aims to evaluate the reporting quality and risk of bias of the current RCT reports of different Rhodiola species. Methods. Six databases including Embase, PubMed, Web of Science, the Cochrane Library, ClinicalTrial.gov, and China National Knowledge Infrastructure were searched to identify RCTs that used Rhodiola as a single intervention and were published in English or Chinese from inception to December 2020. The Consolidated Standards of Reporting Trials (CONSORT) 2010 statement was used as the checklist for assessment, and a scoring system was applied to the evaluation of RCTs. Score 0 represents no reporting or inadequate reporting, and score 1 represents adequate reporting. The risk of bias of the included studies was also assessed using the Cochrane Risk of Bias tool. Results. A total of 39 RCTs were included in this study, including 23 RCTs of Rhodiola rosea (R. rosea), 8 RCTs of Rhodiola crenulata (R. crenulata), and 8 RCTs of Rhodiola wallichiana (R. wallichiana). None of the included studies met all the CONSORT statement criteria, and the reporting quality of RCTs of the three Rhodiola species was all generally poor. Based on the risk of bias assessment, the majority of included studies were judged to have an unclear risk of bias in most domains due to inadequate reporting. Conclusions. There is inadequate reporting among the included RCTs of different Rhodiola species, and RCTs of Rhodiola with higher reporting quality and better methodological quality are needed.

A Multistate Trial of an Early Surveillance Program for Autism Within General Practices in Australia

Background: The early detection of developmental conditions such as autism is vital to ensure children can access appropriate and timely evidence-based supports, services, and interventions. Children who have undetected developmental conditions early in life are more likely to develop later health, developmental, learning, and behavioral issues, which in turn can have a cumulative effect over the life course.Methods: The current protocol describes a multi-site, cluster randomized control trial comparing a developmental surveillance pathway for autism to usual care, using opportunistic visits to general practitioners (GPs). Units of randomization are GP clinics across two Australian states (New South Wales and Victoria), with thirty clinics within each state, each of which will aim to recruit approximately forty children aged between ~18- and 24-months, for a total of ~2,400 participants. Children will be randomized to two clusters; namely, an autism surveillance pathway (ASP) or surveillance as usual (SaU). The screening process for the ASP arm involves primary and secondary screenings for developmental concerns for autism, using both parent and GP reports and observations. Children in both arms who show signs of developmental concerns for autism will be offered a full developmental assessment by the research team at 24 months of age to determine the efficacy of developmental surveillance in successfully identifying children with autism.Trial Registration: The trial is registered with ANZCTR (ACTRN12619001200178) and reporting of the trial results will be according to recommendations in the CONSORT Statement.

The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement

Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.