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ASSESSMENT OF THE QUALITY OF RANDOMIZED CONTROLLED TRIALS IN GASTROINTESTINAL SURGERY FROM INDIA USING JADAD SCORE
Vikram Kate*1, Subair Mohsina1, Niranjan Ravichandran1, Souraja Datta1, Gubbi S. Sreenath1, Sathasivam Sureshkumar1, Thulasingam Mahalakshmy2
1Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, Pondicherry, India; 2Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Introduction: This study was carried out to evaluate the quality of randomized controlled trials (RCTs) in surgical gastroenterology (SGE) from India published in various national and international journals and to identify various factors determining study quality.
Methods: This was a retrospective analytical study on surgical RCTs published from India during 2011- 2015. Medline and Embase search was carried out with the key words such as "randomized controlled trials", " random", "gastroenterology", "surgery" and "India". Studies were included if they were truly randomized, human study and on surgical topics. The primary objective was to quantitatively and qualitatively analyse SGE trials based on year of publication and regional division and to compare with other surgical subspecialties.The secondary objectives were to analyse the quality and quantity of the overall surgical trials and to identify factors affecting the quality of RCTs such as type of institution,number of authors,impact factor, type of intervention and institutional board review. Qualitative assessment was done using Jadad score comprising randomization, blinding and drop-out (high-quality for Jadad score of ≥3.
Results: Among the 813 trials identified on PubMed search, 101 trials were included for analysis. 64.3% of trials were found to be of high-quality. There was no difference in quality or quantity with time (Table 1). Regional variation within country was quantitatively (p=0.041) and qualitatively(p=0.016) significant for SGE and overall surgical trials. In terms of high-quality trials, the specilaties were ranked as: Neurosurgery(2/2), CTVS(1/1),General Surgery(17/22),urology (17/29), surgical-gatroeneterology( 19/36) followed by other specialties. However, the difference in quantity (p=0.25) and quality(p=0.32) of SGE trials when compared with other sub specialities were not significant(Table1). Number of authors, higher impact factor(p=0.049), assistance of statistician(p=0.048) and review by IRB (p=0.002) were found to be significantly associated with a better study quality(Table2).
Conclusions: The quality of SGE trials from India was optimal and was similar to other surgical sub-specialties. The quantity and quality of trials in SGE and overall surgical RCTs from India have remained stable over 5 years with good reporting rates in few subspecialties and regions. Institutional review, more number of authors and higher impact factor were found to be associated with a better study quality.
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