Design, Analyze and Communicate: Working together to improve clinical study outcomes.
Standard of Practice Dataset (SOPD)
The State of Practice Dataset 2 (SOPD2) identifies randomized pharmacological intervention trials conducted in Africa and South Asia across disease areas falling under the categories of communicable, maternal, neonatal, and nutrition (CMNN) (excluding COVID-19). This dataset provides a recent evidence map that is representative of such trials and will be utilized to answer questions about trial characteristics, including methodological attributes.
Despite a trend from 1990-2019 of improving health globally, the greatest proportion of disease burden among the world’s poorest billion is still communicable, maternal, neonatal, and nutrition (CMNN) diseases (65%)(1). Compared with the disease burden in high-income countries, CMNN diseases also account for the largest disparities, with age-standardized DALY rates for CMNN conditions 2,147% higher in the poorest billion. For SOPD2, CMNN disease areas were defined by the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) conducted by the Institute for Health Metrics (IHME)(2). The GBD is global in scope and provides a comprehensive list of CMNN diseases organized into a levelled hierarchy.
To find relevant treatment trials, a systematic literature search was conducted to identify trial publications that were in scope. While limited, the trial publication is likely the most accurate record of the methods used, regardless of what is recorded in the protocol. Systematic literature searches explicitly describe the methodology that will be used to undertake the search which should include clearly stated objectives, eligibility criteria for evidence, and a documented search strategy(3). The key advantages of this systematic approach are that the search results are transparent and reproducible, reducing the potential for bias. The explicit methodology increases the potential utility of the search results and contextualizes the dataset to enable appropriate use. Systematic literature searches are also easily updated over time as new evidence becomes available, reducing duplication of effort.
1. Coates MM, Ezzati M, Robles Aguilar G, Kwan GF, Vigo D, Mocumbi AO, et al. Burden of disease among the world’s poorest billion people: An expert-informed secondary analysis of Global Burden of Disease estimates. PloS One. 2021;16(8):e0253073.
2. Naghavi M, Ong KL, Aali A, Ababneh HS, Abate YH, Abbafati C, et al. Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021. The Lancet. 2024 May 18;403(10440):2100–32.
3. Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, et al., editors. Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022) [Internet]. Cochrane; 2022. Available from: www.training.cochrane.org/handbook
