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A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial
Hossain MS, Harvey LA, Islam S, Rahman A, Muldoon S, Biering-Sorensen F, Jan S, Liu HF, Li Q, Cameron ID, Taylor V, Lindley RI, Billot L, Herbert RD
Spinal Cord 2021 Jun;59(6):649-658
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Randomised controlled trial. OBJECTIVES: To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. SETTING: Bangladesh. METHODS: A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an intervention or control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. RESULTS: Between July 2015 and March 2018, 410 participants were randomised (204 to intervention, 206 to control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the intervention group and 16 (7.8%) participants in the control group had died (hazard ratio from unadjusted Cox model 0.93 (95% CI 0.46 to 1.89); p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. CONCLUSION: A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.
Reprinted by permission from Spinal Cord, Macmillan Publishers Ltd.

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