Quality assessment of published randomized controlled trials in the journal of military medicine during 1999-2015

Abstract

Background and Aim: Randomized Controlled Trials (RCT) are important tools for evidence based health care decisions. The aim of this study was to evaluate the quality of published randomized controlled trials in the Journal of Military Medicine and also follow the trend of changing process of the quality of the report during time. Methods: This study is a journal based assessment. All clinical trials that had been conducted on humans and had a control group during 1999-2015 and were published in the Journal of Military Medicine were included in the current survey. For all articles, data (descriptive) such as year of publication, the university, the sample size and gender of the subjects, the scope of patients, type of outcome, trial and comparison group and the university ethics approval, was extracted. Also, the quality of each clinical trial was carried out by one assessor using CONSORT 2010 and Jadad scale. In this study, in addition to the items individually, the trend of overall score for checklist (Consort 2010) and scale (Jadad) over time (1999 to 2015) were also assessed. Results: Results revealed that 36 RCTs with the consideration of the study criteria (having control group, the study is conducted on humans) were published from 1999 to 2015 in the Journal of Military Medicine. As observed, in 22 (61.1) of the studies, the first author or the corresponding author were from the Baqiyatallah University of Medical Sciences. The parameters which measured the level of physical health, knowledge and skills and readiness, pain, mental and social health outcomes were 23 (63.8 ), 9(25 ), 2 (5.6 ) and 2 (5.6 ) reports, respectively. Also, the cover and dress, chemotherapy, other drug therapy, education, training and other interventions were 4 (11.1), 9 (25), 4 (11.1), 10 (27.8), 7 (19.4) and 2 (5.6), respectively. According to CONSORT checklist (7 items), the best report was related to completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed (6a). In order to survey the trend of CONSORT and Jadad during time periods, time periods were divided them into 4 categories; 2005 and before that, 2006 to 2008, 2009 to 2011 and 2012 to 2015. The changes of the CONSORT index is not significant. The average score of RCT according to the Jadad scale was 1.78±1.12 (35.55 of their maximum possible total score of scale). According to the time period categorization, the changes of the Jadad index was not significant. Conclusion: Some of the weaknesses in the quality of reporting, including the method of randomization, blinding and registration of trial can be improved by using standard reporting tools (e.g. CONSORT checklist and Jadad Scale) in the process of submitting and thesis judgment, by training courses held by journal editors for researchers and also by using methodologists' consult.