BMJ global health · 2025
A pilot study on the acceptability and safety of collaborative triage and treatment with traditional bonesetters for extremity fracture patients: a stepped-wedge, cluster-randomised controlled trial in rural Tanzania.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Binnerts Joost J, Hendriks Thom Cc, Okoth Jovine, Harun Nkaina W, Gill-Wiehl Annelise, Bempong-Ahun Nefti, Ibbotson Geoffrey C, Harrison William J, Martin Claude, Edwards Michael J, Hermans Erik, Chirangi Bwire M
Аннотация
INTRODUCTION: Fracture patients in resource-limited settings frequently attend traditional bonesetters (TBSs), often resulting in non/malunion or infectious complications. Intersectoral collaboration between formal healthcare and TBSs has the potential to make this practice safer but has never been tested previously. This pilot study assesses the acceptability and safety of collaborative fracture management (CFM).
METHODS: Within a pilot stepped-wedge cluster-randomised controlled trial, we included three TBSs (clusters) and their extremity fracture patients from Rorya district, Tanzania. We randomly assigned TBS timepoints to transition from standard TBS care (control) to CFM (intervention). CFM consisted of X-ray imaging, analgesia and guideline-based discussion between a doctor and TBS to guide definitive fracture management. Patient follow-up was at 1, 3 and 6 months postinclusion. In an intention-to-treat analysis, we estimated average treatment effects through ordinary least squares and Poisson regression for primary outcomes of protocol adherence, patient satisfaction and number of complications. The trial is registered at the Pan-African Clinical Trial Registry (PACTR202307910320431) and is completed.
RESULTS: Between 28 August 2023 and 28 April 2024, we included 21 intervention (9 females, 12 males) and 31 control patients (11 females, 20 males). Protocol adherence was 66.7% in the intervention group, with prohibitive cost and fear of surgery being the most common reasons for non-adherence. Mean satisfaction, quality of life and disability did not differ statistically between groups. Intervention patients had 0.072 less complications than control patients (95% CI -0.11 to -0.031, p=0.001), corresponding with a number-needed-to-treat of 13.9 patients to prevent one complication.
CONCLUSION: Our results suggest CFM is acceptable and safe to patients and TBSs, offering a model to improve fracture care in resource-limited settings worldwide. To improve the model's efficacy, additional strategies are necessary to overcome socioeconomical and educational barriers to surgery. Future research could investigate the generalisability of our findings in other settings.
METHODS: Within a pilot stepped-wedge cluster-randomised controlled trial, we included three TBSs (clusters) and their extremity fracture patients from Rorya district, Tanzania. We randomly assigned TBS timepoints to transition from standard TBS care (control) to CFM (intervention). CFM consisted of X-ray imaging, analgesia and guideline-based discussion between a doctor and TBS to guide definitive fracture management. Patient follow-up was at 1, 3 and 6 months postinclusion. In an intention-to-treat analysis, we estimated average treatment effects through ordinary least squares and Poisson regression for primary outcomes of protocol adherence, patient satisfaction and number of complications. The trial is registered at the Pan-African Clinical Trial Registry (PACTR202307910320431) and is completed.
RESULTS: Between 28 August 2023 and 28 April 2024, we included 21 intervention (9 females, 12 males) and 31 control patients (11 females, 20 males). Protocol adherence was 66.7% in the intervention group, with prohibitive cost and fear of surgery being the most common reasons for non-adherence. Mean satisfaction, quality of life and disability did not differ statistically between groups. Intervention patients had 0.072 less complications than control patients (95% CI -0.11 to -0.031, p=0.001), corresponding with a number-needed-to-treat of 13.9 patients to prevent one complication.
CONCLUSION: Our results suggest CFM is acceptable and safe to patients and TBSs, offering a model to improve fracture care in resource-limited settings worldwide. To improve the model's efficacy, additional strategies are necessary to overcome socioeconomical and educational barriers to surgery. Future research could investigate the generalisability of our findings in other settings.