REPORTING QUALITY OF DOUBLE-BLIND RANDOMIZED CONTROLLED TRIALS AND ITS ASSOCIATION WITH THE FUNDING AGENCY
Author(s)
Nitesh Singh, MPharm, Senior Associate, Rumjhum Agrawal, MPharm, Executive Associate, Seema Dimri, MPharm, Associate, Bhavesh S Ubhadiya, MPharm, Senior Associate, Pushkar Narvilkar, MPharm, Executive Associate, Mayank Bhanderi, MPharm, Senior AssociateHeron Health Private Limited, Chandigarh, India
OBJECTIVE: To assess the reporting quality of double-blind randomized controlled trials (RCTs) published in the New England Journal of Medicine (NEJM) using Jadad scale and to examine the relationship between funding source and quality of reporting. METHODS: Medline database was searched for RCTs. Search was limited to RCTs published in the last five years in the NEJM and performed on humans. Quality of reporting was assessed using the Jadad scale (1 to 5). The analysis was limited only to the double-blind RCTs assessing drug or vaccine based intervention. RESULTS: A total of 207 double-blind trials out of 489 RCTs were assessed for reporting quality. Median (mean) Jadad score was 4 (3.8). The proportion of trials with Jadad score 5 was 20.8% whereas 5.8% trials received a Jadad score of 2. None of the trials received a Jadad score of 1. Method of randomization and concealment of allocation was adequate in 35.3% and 47.8% trials, respectively. Method of blinding was adequate in 51.2% of trials. A total of 89.4% trials reported details of follow-up and reasons for withdrawal. The quality of reporting was good (Jadad score ≥ 3) in 94.2% studies. Year-wise analysis showed that 100%, 91%, 91%, 94% and 96% studies were of good reporting quality in the year 2004, 2005, 2006, 2007, and 2008, respectively. A Jadad score of 5 was received by 41% (9 out of 22) government sponsored trials as compared to only 14% (15 out of 107) trials sponsored by industry. CONCLUSION: There is a scope for further improvement in reporting of method for randomization, concealment of allocation and method of blinding. Influence of funding agency on the quality of reporting could be analyzed further.
Conference/Value in Health Info
2009-05, ISPOR 2009, Orlando, FL, USA
Value in Health, Vol. 12, No. 3 (May 2009)
Code
PMC91
Topic
Methodological & Statistical Research
Topic Subcategory
Modeling and simulation
Disease
Multiple Diseases