Evaluation of the Quality of Publications on Randomized Clinical Trials Using the Consolidated Standards of Reporting Trials (CONSORT) Statement Guidelines in a Spanish Tertiary Hospital

Abstract

The main reason for conducting a clinical trial (CT) is to test the effect of a drug or medical procedure to improve treatment of a disease. CTs contribute most when they are rigorously conducted and the results are published adequately. The aim of this study is to assess, using the CONSORT statement guidelines, the quality of reporting of completed CTs conducted at a tertiary hospital to determine which sections of the articles should be improved. CTs published between 2002 and 2008 were identified by searching the MEDLINE and Cochrane Library. Forty of 127 completed CTs were published. There was a marked increase in the number of articles and the quality of the journals that published the CTs over time. Although the articles were published in high-impact index journals, the Consolidated Standards of Reporting Trials (CONSORT) score reporting quality of the articles varied substantially, which indicates that they should be improved. The title, abstract, introduction, and discussion sections received the highest CONSORT scores and need little improvement. Poor reporting of methodological details and discussion on limitations and strengths were observed. In conclusion, much improvement remains to be made in the quality of reporting of CTs to allow reliable quality assessment of published trials.

Assessment of the Reporting Quality of Randomized Controlled Trials on the Treatment of Diabetes Mellitus with Traditional Chinese Medicine: A Systematic Review

“…Firstly, CONSORT is officially supported by the World Association of Medical Authors and the International Committee of Medical Journal Editors. Secondly, several reports demonstrated that the quality of reporting could be improved if the CONSORT statement was followed more closely[37]–[40]. Thirdly, CONSORT has been applied in many other medical specialities[41]–[43].…”

“…Francisco Dasí et al concluded that “even high-impact journals publish articles of unsuitable quality” [40].…”

Clinical Predictors for Upper Limb Recovery after Stroke Rehabilitation: Retrospective Cohort Study

“…The primary outcome measure was the FMA-UE, a reliable and validated 66-points outcome measure quantifying arm motor function after stroke [25]. Other clinical outcome measures were: FMA for sensory function (FMA-sensation); Box and Blocks Test (BBT) for gross manual dexterity [26]; Modified Ashworth Scale (MAS) for measuring muscle tone at biceps brachii [27]; Functional Independence Measure ( FIM) for autonomy in ADLs [28].…”

From the Editor's desk

“…Have these guidelines had sufficient impact on the reporting and the accessibility of research to the wider public, as well as clinicians and researchers? It appears that the answer to this is no, at least not in psychiatry 8,9 nor for pharmacological 10 and nonpharmacological trials in general, 11 for trials of treatments for cancer 12 nor for some trials in anaesthetics. 13 Psychiatric studies are especially challenging as the trials can include pharmacological and non-pharmacological interventions, devices, surgery, psychological treatments, complex multi-component interventions in hospital or community settings, public health and policy interventions in single or cluster randomised designs, and more.…”