Neurosurgical Randomized Trials in Low- and Middle-Income Countries

Abstract

Background: The setting of a randomized trial can determine whether its findings are generalizable and can therefore apply to different settings. The contribution of low- and middle-income countries (LMICs) to neurosurgical randomized trials has not been systematically described before.

Objective: To perform a systematic analysis of design characteristics and methodology, funding source, and interventions studied between trials led by and/or conducted in high-income countries (HICs) vs LMICs.

Methods: From January 2003 to July 2016, English-language trials with >5 patients assessing any one neurosurgical procedure against another procedure, nonsurgical treatment, or no treatment were retrieved from MEDLINE, Scopus, and Cochrane Library. Income classification for each country was assessed using the World Bank Atlas method.

Results: A total of 73.3% of the 397 studies that met inclusion criteria were led by HICs, whereas 26.7% were led by LMICs. Of the 106 LMIC-led studies, 71 were led by China. If China is excluded, only 8.8% were led by LMICs. HIC-led trials enrolled a median of 92 patients vs a median of 65 patients in LMIC-led trials. HIC-led trials enrolled from 7.6 sites vs 1.8 sites in LMIC-led studies. Over half of LMIC-led trials were institutionally funded (54.7%). The majority of both HIC- and LMIC-led trials evaluated spinal neurosurgery, 68% and 71.7%, respectively.

Conclusion: We have established that there is a substantial disparity between HICs and LMICs in the number of published neurosurgical trials. A concerted effort to invest in research capacity building in LMICs is an essential step towards ensuring context- and resource-specific high-quality evidence is generated.

Keywords: Access to care; Global health; Global neurosurgery; Global surgery; Health disparities; Low- and middle-income countries; Neurosurgery; Neurotrauma; Research; Research capacity strengthening; Spinal surgery.

FIGURE 1.

Application programming interface (API) coordinates of lead sites reveals the concentration of hubs of research. Each blue dot represents the location of the lead site. ArcGIS software was used to generate a kernel density heat map based on the latitude and longitude of each site.

FIGURE 2.

The annual healthcare expenditure per capita ranges from 24.96 international-$ in the Central African Republic to 9402 international-$ in the United States, based on data from fiscal year 2013/2014. Total health expenditure is the sum of public and private health expenditures as a ratio of total population. Data are in international dollars converted using 2011 purchasing power parity (PPP) rates. “Annual healthcare expenditure per capita, 2014” map from “Financing Healthcare” by Estaban Ortiz-Ospina and Max Roser (https://ourworldindata.org/financing-healthcare), licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/deed.en_US). Data are from World Bank–World Development Indicators, World Health Organization Global Health Expenditure database (see http://apps.who.int/nha/database for the most recent updates).