Introduction of Nurse-Led Rehabilitation Services for Patients With Stroke After Discharge to Improve Self-Care Management in Bangladesh: Pilot Randomized Controlled Trial.
Salma Akhter, Katm Ehsanul Huq, Shota Date and 7 others
No significant difference between the nurse-led group and usual care on functional independence, self-efficacy, social participation, or caregiver burden at 3 months.
Both groups improved, and the control group also received external rehabilitation, so the null result does not mean the intervention failed.
Key findings
1The primary outcome, functional independence on the FIM scale, showed no significant difference between the nurse-led group and usual care at 3 months, although both groups improved over time.
2The control group also received rehabilitation from external sources (home-based services and the Centre for the Rehabilitation of the Paralyzed), which the authors could not restrict for ethical reasons, and this likely accounts for the comparable improvements seen in both groups.
3Sixteen of 64 participants (25%) died during the first month of the study, leaving 47 for analysis and underpowering the trial.
Still to come
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What it does not show
25% of participants died in the first month, leaving only 47 of 64 for analysis and underpowering the study The control group received external rehabilitation (home-based and CRP services) that the authors could not restrict for ethical reasons, making it impossible to isolate the effect of the nurse-led intervention Three-month duration is short for measuring functional recovery after stroke Conducted only in urban Dhaka, limiting generalizability to rural Bangladesh Open-label design with no blinding of participants or assessors mRS 4 (severe disability) was included, which may limit the potential for measurable physical improvement Per-protocol analysis excluded 17 participants (16 deaths, 1 lost to follow-up), which may bias results
Declared interests
None declared.
The easy way to misread this
Do not read the null result as evidence that nurse-led rehabilitation or assistive devices are ineffective. The control group also received external rehabilitation services (home-based and CRP) that the authors could not restrict for ethical reasons, and 25% of participants died in the first month, leaving the study underpowered. The absence of a between-group difference here does not mean the intervention has no effect; it means this study could not detect one.
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