Thomas 2015.

Study characteristics
Methods	Aim of study: to assess the feasibility of a full‐scale cluster randomised trial and conduct a preliminary evaluation of supported implementation of a systematic voiding programme for incontinence compared to usual care Study design: cluster randomised trial Unit of randomisation: stroke service Mean cluster size: information not available. 4 clusters in each arm. Unit of analysis: patient Sample size calculation: sample size chosen pragmatically rather than based on formal sample size calculation. The aim was to balance practicalities and the need for 'reasonable precision' in the estimation of effects to inform the sample size calculation. Expected to recruit 780 patients across the 12 services.
Participants	Healthcare professionals: 12 stroke services comprising nurses (ranging in grade from healthcare assistants to ward managers), occupational therapists and physiotherapists. Demographics of staff within clusters not provided. Patients: stroke survivors (n = 413) Intervention A: n = 164, 52% men, median age 77 (IQR 68–83) years Intervention B: n = 125, 42% men, median age 81 (IQR 74–85) years Control: n = 124, 41% men, median age 80 (IQR 72–86) years Ethnicity: Intervention A: white 96% Intervention B: white 95% Control: white 99% Setting: inpatient stroke units (acute and rehabilitation) Country: UK
Interventions	Targeted behaviour change: for staff to deliver a systematic voiding programme with stroke survivors with incontinence Theory used: Normalisation Process Theory Category of implementation intervention: delivery arrangements and implementation strategies Multifacetedintervention: yes Tailoring to barriers: yes Semistructured interviews conducted with staff to identify barriers to successful implementation Description of intervention: Intervention A: interprofessional education, educational materials Intervention B: interprofessional education, educational materials, local opinion leaders, educational outreach visits (See Appendix 2 for full details of intervention) Delivery: Intervention A: training mainly web‐based, face‐to‐face sessions also offered to staff Intervention B: training as per Intervention A. Educational outreach (External facilitators) provided support through a mixture of face‐to‐face meeting, teleconferences and e‐mail correspondence Frequency: information not available Duration of intervention: unclear Control: no intervention
Outcomes	Main outcome: Patient outcomes: presence or absence of urinary incontinence measured by ICIQ‐UI Short Form Secondary outcomes: Quality of life measured by I‐QOL and EQ‐5D Frequency and severity of incontinence measured by the ISI Urinary symptoms measured by Leicester Urinary Symptom Questionnaire Activities of daily living measured by Barthel Index Death Follow‐up: 6, 12 and 52 weeks' poststroke Loss of clusters and individuals: no clusters lost to follow‐up. Adjusted for clustering for each outcome: authors stated little or no evidence of clustering effects, with ICC estimates mostly being very close to 0 Method of cluster adjustment for each outcome: mixed‐effects modelling for continuous, ordinal and dichotomous outcomes were used to compare the 2 groups on primary outcome data and account for clustering ICC reported for each outcome: yes
Notes	Outcomes used in this review: Presence or absence of urinary incontinence measured by ICIQ‐UI Short Form Quality of life measured by I‐QOL Frequency and severity of incontinence measured by the ISI Activities of daily living measured by Barthel Index Death rates We pooled death rates from this trial as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions Section 23.1.4.1 and applied a design effect to the number of participants and events to account for the clustering. Unit of analysis error: no Ethical approval and informed consent obtained (yes/no): yes. Local research ethical approval was granted by Bolton Research Ethics Committee (09/H1009/15). Approval was also obtained from the University of Central Lancashire Faculty of Health and Social Care Ethics Committee (FHEC) (CA 138). Informed consent obtained from all patients. Funding source: National Institute for Health Research Programme Grants for Applied Research programme. Declarations of interest: 1 author was a member of the National Institute for Health Research (NIHR) Programme Grants for Applied Research subpanel and a member of the NIHR Journals Editorial Board. Contact with author? yes Additional outcome data provided from author? no Trial registration: ISRCTN08609907
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Trial arms stratified into 4 strata, randomisation schedule was then generated using block randomisation to allocate 1 site to each arm within each stratum, using computer software package Stata.
Allocation concealment (selection bias)	Unclear risk	Allocation based on clusters, stroke services not informed of intervention allocation until all services recruited. Within each stratum, stroke services were not aware of their allocation until all within that stratum were recruited for trial. However, when 2 sites required substitution, the rest of the stratum were already aware of their allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	After recruitment, all patients, recruiting staff and stroke services were aware of allocation.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Research nurses completed outcome measures, they were not blinded. They originally planned to collect data in sites other than their own to assure blinding; however, this was ultimately not possible due to geographical location.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No clusters lost. Attrition rates between groups were similar at 12 weeks (the primary point of analysis) (24.2% Intervention A, 24% Intervention B, 26.5% control). Overall response rate for questionnaires were similar (97% Intervention A, 92% Intervention B, 98% control).
Selective reporting (reporting bias)	Low risk	Published protocol, all proposed primary and secondary outcomes reported.
Other bias	High risk	Recruitment bias: low risk Incorrect analysis: low risk Similar baseline characteristics: high risk, some differences in baseline characteristics, e.g. more males in intervention group A (52%) compared with control group (41%) and intervention group B (42%). The proportion of participants with no symptoms on the modified Rankin Scale was slightly higher in the control group (42%) compared with intervention group A (33%) and intervention group B (27%). There were also fewer patients with the most severe stroke subtype (total anterior circulation syndrome) in the control group (29.8%) compared with intervention group A (48.8%) and intervention group B (54.4%). Authors discussed that there may have been some consent and recruitment bias by research nurses. Similar baseline outcome measures: low risk, similar continence status at baseline between groups (% incontinent at baseline: 85% intervention group A, 89% intervention group B, 90% control group). Reliability of primary outcome measures: low risk, ICIQ‐UI Short Form is considered to have acceptable reliability, validity and responsiveness. The authors conducted a preliminary validation of the tool with 6 stroke survivors and found it appropriate. Adequate protection against contamination: low risk, allocation by stroke service.

CBS: Carer Burden Scale; CTRU: Clinical Trials Research Unit; ECAQ: Elderly Cognitive Assessment Questionnaire; EQ‐5D: European Quality of Life‐5 Dimensions; EQ‐5D‐3L: 3‐level version of EQ‐5D; FAI: Frenchay Activities Index; GHQ‐12: General Health Questionnaire‐12; HADS: Hospital Anxiety and Depression Scale; iCaPPES: integrated Care Pathway for Post Stroke; ICC: intraclass correlation coefficient; ICIQ‐UI: International Consultation on Incontinence Questionnaire – Urinary Incontinence; IQR: interquartile range; ISI: Incontinence Severity Index; ITT: intention to treat; KT: knowledge translation; KTA: Knowledge to Action; LoTS: Longer‐Term Stroke; LSCTC: London Stroke Carers Training Course; LUNS: Longer‐term Unmet Needs after Stroke; M‐MMSE: Modified Mini‐Mental State Examination; MRC: Medical Research Council; n: number of participants; NEADL: Nottingham Extended Activities of Daily Living; NHMRC: National Health and Medical Research Council; NHS: National Health Service; PHQ‐9: Patient Health Questionnaire‐9; SD: standard deviation; SIS: Stroke Impact Scale; TQWHQ: Two Questions With Help Questionnaire.