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.

	Trial design	Intervention dose	Risk of bias
Quality Items	Based on MRC guidelines; (1) Trial registered? †‡; (2) Committee oversee of trial? †‡; (3) Hypothesis stated? ‡; (4) Trial phase reported?; (5) Biological rationale of intervention included?; (6) Treatment compliance measured? †; (7) Actual treatment participants received measured & reported?; (8) Adverse events recorded? †; (9) Single- or multi-site trial?; (10) Primary outcome specified? †	Based on TIDIER guidelines§; (1) Intervention dose justified?; (2) Dose schedule reported sufficient for replication?; (3) Dose intensity reported?	Extracted from Cochrane reviews; (1) Sequence generation adequate?; (2) Allocation concealment adequate?; (3) Risk of detection bias addressed? ||
Trial Methods	(1) Purpose of study; (2) Type of comparison group; (3) Was the trial international?; (4) Sample size; (5) Use of stratification; (6) Days post-stroke at baseline; (7) Was intervention piloted (if not a pilot study)? †; (8) Description of intervention components; (9) Use of device in intervention	(1) Individual or group treatment?; (2) Individually tailored dose?; (3) Dose progression?; (4) Dose schedule: session length (minutes), sessions per day & per week, duration (weeks); (5) Dose matched between groups?	(1) What was primary outcome? #; (2) Positive trial? #; (3) Number of outcome measures; (4) List of outcome measures

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].