Review Article
Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review
Table 1
Data extraction items: characteristics of trial design, intervention dose, risk of bias, and other methodological features.
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Note. Based on Medical Research Council guidelines for developing and evaluating complex interventions [13]. †If authors did not report these details, this was recorded as "no" in data extraction. ‡Based on best practice methods but not stated in Medical Research Council guidelines. §TIDieR guidelines [12]. | |Reported in Cochrane review as "Blinding all outcomes", "Blinding: performance and detection bias", or "Blinding: outcome assessors". #When no primary outcome was specified by authors, the outcome most closely matching the purpose of the trial was nominated by data extractors. Comparison group categories: usual care, other active intervention, waitlist, sham intervention, or attention control. Dose intensity: prespecified treatment target (i.e., the amount of physical or mental work) that participants attempted to reach in a given session (either uniform for all participants or individually tailored) [15]. Dose schedule: session length (minutes), number of sessions per day, number of sessions per week, duration of intervention (weeks), and total number of sessions. Positive trial: a significant difference between groups on the primary outcome after intervention, in favour of the intervention group [1]. Sites: single site= hospital inpatient-based intervention conducted at a single site. Multi-site= inpatient based intervention conducted at 2 or more sites. Multi-country= studies conducted in more than one country. Trial phase: research phase of randomised controlled trial—development, feasibility or piloting, and evaluation—based on the Medical Research Council Guidelines for developing and evaluating complex interventions [13]. |