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.

Neurosurgeons’ experiences of conducting and disseminating clinical research in low-income and middle-income countries: a reflexive thematic analysis

“…While neurosurgery is in its infancy in many LMICs the development of relevant guidelines is increasingly important. 8 However, LMICs still do not have sufficient evidence to inform neurosurgical practice and improve health. 30 Neurosurgeons in this study understood that research was integral to improving health outcomes 10 31 and for many drove them to conduct research to affect care.…”

“…29 In the context of advancing neurosurgical technologies funding becomes even more important and more must be done to increase investment in research. 8 Prioritisation of journal publication over improved policy and practice are considered poor incentives to impactful research. 10 Neurosurgeons in this study were aware of both favourable and unfavourable consequences of mandatory research; increasing capacity, while increasing low impact designs.…”

“…Tropeano et al 6 found Latin America, Africa and Southeast Asia had publication outputs of 1.73%, 1.12% and 1.03%, respectively. 7 Griswold et al 8…”

International Neurotrauma Training Based on North-South Collaborations: Results of an Inter-institutional Program in the Era of Global Neurosurgery

“…Fellows have contributed significantly to the global neurosurgery academic community, presenting their research at international conferences such as the International Conference for Recent Advances in Neurotraumatology (ICRAN) and publishing in highly reputable journals like NEUROSURGERY, Frontiers in Neurology, and World Neurosurgery (13)(14)(15)(16). They perform most of the research activities while based in Colombia in different centers in a broad level of resource availability.…”

Neurosurgeons’ experiences of conducting and disseminating clinical research in low- and middle-income countries: a qualitative study protocol

“…A recent review to identify randomised trials of neurosurgical procedures used in cranial and spinal neurosurgical practice found only 8.8% of studies (excluding China) were LMIC-led studies. 8 LMICs need to develop an evidence base that is relevant to the treatments and interventions accessible to them. 3 7 Nurturing an environment that promotes high-quality neurotrauma research is a fundamental part of this.…”