Methodological and ethical quality checklist assessment in issues of Annals of Family Medicine Clinical Trials (2010-2013)

Abstract

Abstract Introduction: At present, the quality of the publication of Control Trials (CTs) in medical journals improved due to the inclusion of the CONSORT (CONsolidated Standards of Reporting Trials) standards and the Declaration of Helsinki. The aim is to analyse methodological and ethical quality of published CTs in Annals of Family Medicine journal. Material and methods: We use a 133-item checklist divided into 11 sections based on CONSORT and the Declaration of Helsinki. The Confidence Interval of 95% (95% CI) of Clopper-Pearson for κ average is calculated. Results: We found 35 CTs in a literature review (2010-2013) on March 25, 2014 according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analysis). CT was mentioned in all heading/subheadings; CT controlled parallels in 80%; cluster type 45.7%. The most observed method was masked, active-controlled, decentralized randomization. The most frequently found category was an open CT assessing a medical intervention, with a positive significant result surveyed. The most common Informed Consent (IC) was in writing, not clearly voluntary, without prior knowledge and doubtful. It was not withdrawn in 45.7% of cases. A grant/scholarship was found to be the most frequent incentive for researchers. In 28 CTs there was no conflict of interest. The κ average was 0.93 (95% CI, 0.90-0.96). Conclusions: CT published “standard” characteristic are indicated. Following the CONSORT standards publication, it has increased the overall quality of the CTs published. But there are some areas for improvement in the methodological and ethical quality of the CTs published from 2010 to 2013 in Annals of Family Medicine.