Abstract
To evaluate the reporting quality of randomized controlled trials (RCTs) regarding patients with COVID-19 and analyse the influence factors. 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. 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). 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.
Highlights
With the development of evidence-based medicine, randomized controlled trials (RCTs) became the gold standard to compare the effectiveness of different interventions [1]
Future RCTs should focus on improvement of detailed reporting in allocation concealment, blinding and estimation of sample size
Poor reporting quality of RCTs is the major barrier to evidence-based practices, as it can distort the available evidences in the medical literature, and prevent clinical decision-makers from obtaining true results from trials [13]
Summary
Ethical approval was not necessary for this study, as the study did not involve patients and included RCTs can be traced from databases. Two authors independently extracted the general characteristics and reporting data of included studies into Excel, any discrepancy was resolved through discussion. The general characteristics include continent of first-author, number of authors, sample size, age and type of participants, the type of interventions, journal impact factor and journals’ endorsement of the CONSORT statement. The CONSORT statement was chosen as a tool to assess reporting quality of these RCTs [7]. We assessed the compliance of each RCT by 25 items of CONSORT statement, each checklist item and subitem was answered with “yes” or “no”. Descriptive statistics was performed to describe general characteristics of 53 studies and the reporting rate of each checklist item/subitem. T-test and ANOVA were used for univariate analysis, multiple linear regression analyses were used to determine the association between potential predictors and reporting quality.
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