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.

A Systematic Review and Meta-analysis of the Effects of Music Therapy on Postpartum Anxiety and Pain Levels

Introduction: Postpartum anxiety may be associated with depression, postpartum blues, and maternal mood disorders. This systematic review investigated the effects of music therapy on postpartum anxiety and pain levels. Methods: English databases including Cochrane, Medline, Embase, Web of Science, Scopus, and PubMed and Persian databases including Scientific Information Database (SID) and the Iranian Registry of Clinical Trials (IRCT) were searched. The data were analyzed in RevMan 5.3 and reported as forest plots. The present study was conducted on postpartum women (i.e., the participants). All randomized controlled trials comparing the effects of music (i.e., the intervention) and placebo or routine care (i.e., the control) on postpartum anxiety and pain (i.e., the outcome) were included in the study. Results: Out of a total of 60 retrieved articles, four eligible articles were selected and entered the meta-analysis process. According to the results, anxiety (MD=-0.68, 95% CI=-1.90 to -0.54, P<0.001) and pain (MD=-1.85, 95% CI=-3.96 to 0.26, P<0.001) levels of patients in the music therapy group were reduced more significantly than those in the control group. Conclusion: The results showed that music therapy can significantly reduce both postpartum anxiety and pain scores. However, due to the high heterogeneity of the studies, more randomized trials using a standard tool such as the Consolidated Standards of Reporting Trials (CONSORT) statement are needed.

Effectiveness of Two Different Methods on the Perceived Pain and Satisfaction During Intramuscular Antibiotic Injection: ShotBlocker and Local Vibration

In this study aimed to examine the effectiveness of ShotBlocker and local vibration on the perceived pain and satisfaction during intramuscular antibiotic injection. The sample of the randomized controlled experimental study consisted of 100 patients (32 in vibration group, 35 in ShotBlocker group, 33 in control group) who applied to the adult emergency clinic for antibiotic (amoxicillin/cefuroxime sodium) injection between April and May 2021. The study data were collected using the Structured Information Form, VAS for Pain and VAS for Satisfaction. CONSORT statement was followed for reporting. After the intramuscular antibiotic injection, a significant difference was found between the groups in terms of the mean scores of VAS for Pain and VAS for Injection Satisfaction ( p < .001). It was determined that local vibration application was more effective in reducing the pain and in increasing satisfaction that occurs during intramuscular antibiotic injection according to ShotBlocker and control groups.

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.

1041 A Systematic Review of the Reporting Quality of Surgical Randomised Controlled Trials in Head and Neck Cancer using the CONSORT Statement

Introduction Randomised controlled trials (RCTs) are considered the gold standard for evaluating the efficacy of an intervention. However, previous research has shown that surgical specialities poorly report RCTs, making it difficult to ascertain if various biases have been appropriately minimised. This systematic review assesses the reporting quality of surgical head and neck cancer RCTs. Method A literature search of PubMed and Embase was performed. Papers were included if they reported RCTs which assessed a surgical technique used to treat or diagnose head and neck cancer published during or after 2011. Therefore, the CONSORT 2010 checklist was used to evaluate the reporting quality of these trials. Results 41 papers were included. The mean CONSORT score was 16.5/25 (66% adherence) and the scores ranged from 7.5 (30%) to 25. The most common omissions were full trial protocol (found in 14.6%), participant recruitment method (22%) and effect size with precision estimate for all outcome measures (29.3%). The full design and implementation of the randomisation method was reported in 6 (14.6%). Papers published in journals which endorsed CONSORT had significantly higher scores (p = 0.02) and journal impact factor was significantly correlated with CONSORT score (p = 0.01). Conclusions We have identified several pieces of information that are underreported in surgical head and neck cancer RCTs. These omissions make understanding and comparing the methodologies and conclusions of RCTs more difficult. The endorsement of CONSORT by journals improved adherence, suggesting that wider adoption of the checklist may improve reporting.

Recruiter Characteristics, Recruitment Strategies And The Influence On Recruitment Targets And Timelines In Randomised Controlled Trials: An Observational Retrospective Study of Ovarian Cancer Trials

BackgroundAchieving recruitment targets is a challenge to every clinical trial’s success. Ovarian cancer (OC) accounted for 1.7% of all cancers diagnosed in Europe in 2012, equating to 238,719 women. As these patients have limited treatments available, it is essential that OC trials achieve their recruitment targets to prevent early termination and unanswered research questions. There is evidence to suggest that the characteristics of the recruiter has an influence on a patient’s clinical trial acceptance, however there is little real world evidence to support this. The aims, and primary outcomes, of this study were to determine if recruiter characteristics reported in OC clinical trials have an influence on recruitment targets and timelines. The secondary outcome was the number of OC clinical trials with publically available recruitment strategies.MethodsA two-step search strategy was applied to identify OC clinical trials. Searches were conducted in Cinahl, PubMed, Medline (OVID and EBSCO) and separately in the New England Journal of Medicine, American Cancer Society Journals, Lancet Oncology, Journal of Clinical Oncology and BMC Cancer and clinicaltrials.gov. Data extracted were recorded as dichotomous variables (reported=1, not reported=0).ResultsA total of 88 OC clinical trials were included. 31% (n=28) made reference to the recruiter but this was reported only in the protocol. None of the trials reviewed which closed early or extended recruitment timelines due to slow accrual reported measures taken to improve recruitment rates before stoppages or changes took place. Due to poor reporting, it is not possible to determine whether recruiter characteristics in clinical trials have any influence on recruitment targets or timelines. None of the trials included published their recruitment strategy. Two trials (2%) referred to recruitment strategies in the protocol.ConclusionsIt was not possible to determine the influence of recruiter characteristics on recruitment timelines and targets due to a lack of reporting. None of the included trials published their recruitment strategies. Reporting standards of recruiter characteristics and recruitment strategies must improve to allow identification of effective interventions and dismissal of ineffective ones. This should be done through addition to the CONSORT statement.

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