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. 2021 Jul 1;2021(7):CD003586. doi: 10.1002/14651858.CD003586.pub4

Goedert 2020.

Study characteristics
Methods RCT
Setting: inpatient rehabilitation facility, USA
Participants Less than 60 days post stroke, first clinical stroke, unilateral right brain
Event as confirmed by clinical computed tomography or magnetic resonance imaging, and BIT score at screening indicative of neglect (< 129)
Age, years: 65.6 control, 61.8 prism 
Sex: 5 men/4 women = control, 4/4 = prism 
Hemisphere damaged: right
Time since stroke: 9 to 50 days post stroke
Interventions Prism adaptation. Those randomised to the prism group received prism adaptation treatment once a day for 10 days (5 days per week for 2 weeks). Prism adaptation sessions were timed and each lasted approximately 15 to 20 minutes. Control group received usual care
Outcomes
  • BIT

  • CBS


Outcomes were measured up to 24 weeks post intervention. For comparability with other studies, we used outcomes at week 6 post intervention
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information on process used despite detailed appendix
Allocation concealment (selection bias) Unclear risk Administrative (likely junior?) staff member tasked with list. Unblinded allocation and possibly post‐hoc evaluation “approximately half‐way through data collection” imply absence of proper quality control process
Blinding of participants High risk Not possible
Blinding of personnel High risk Not possible
Blinding of outcome assessment (detection bias)
All outcomes High risk Not attempted
Incomplete outcome data (attrition bias)
All outcomes High risk Omission of 2 (11%) cases from prism arm, who did not (could not?) do more than 4 of planned 10 sessions
Selective reporting (reporting bias) Low risk No evidence of this
Other bias Unclear risk
  • Data‐driven inclusion of co‐variates in analysis and omission of outliers

  • Change to randomisation ratio may favour prism group if (as likely) care improved during trial