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. 2015 Mar 3;2015(3):CD010523. doi: 10.1002/14651858.CD010523.pub2

Tsay 2004.

Methods Study design: RCT
Unit of randomisation: patient
Unit of analysis: patient
Funding sources: National Science Council of Taiwan
Conflicting interests: not stated
Participants Country: Taiwan
Setting: Dialysis centres in 2 hospitals
Conditions/numbers: 50 patients with end‐stage renal disease (ESRD) (25 intervention, 25 control)
Multi‐morbidity: n/a
Health literacy: n/a
Interventions Theoretical framework: n/a
Focus: patient
Type of intervention: Structured, face‐to‐face self‐management support
Clinicians involved: Nurse (additional)
Tools: The programme focused on helping participants develop skills and self awareness in goal‐setting, problem‐solving, stress management, coping, social support and motivation. It included participant identification of problem areas for self management of ESRD, the exploration of emotions associated with these problems, the development of a set of goals and strategies to overcome these problems and for achieving the goals, making a behavioural change plan, and initiating self‐care behaviours and stress management. Participants received an information package + individual consulting sessions 3 times a week for 4 weeks (p. 61).
Stages completed: Limited ‐ B, C, F
Usual provider aware of patient's goals and action plans: Not stated
Standardisation of clinician input: Strong ‐ single clinical nurse specialist provided coaching (p. 61)
Fidelity: not reported
Attrition: no drop‐outs
Comparison: Information package + usual care
Outcomes Health status:psychological: Beck Depression Inventory
Self‐management capabilities: Empowerment scale, Strategies used by People to Promote Health (SUPPH)
Health behaviours: n/a
Achievement of personal goals: n/a
Service use: n/a
Adverse events: none reported
Length of follow‐up: baseline, 6 weeks
Notes No primary outcome. Power calculation performed and number of participants reported as adequate but few details provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were assigned to experimental or control group based on SPSS statistical randomisation software (p. 60)
Allocation concealment (selection bias) Unclear risk Researcher and nurse were aware of which treatments participants were receiving, but data collector was not.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants' usual caregivers (physicians, nurses, dieticians, and/or social workers) were uninformed about treatment group (p. 61), but not possible to blind participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The data collector was a trained research assistant who was unaware of the participant's status to maintain double‐blind accuracy. (p. 61)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No drop‐outs in either group.
Selective reporting (reporting bias) Unclear risk No published protocol. Results reported for all outcome measures.
Other bias Low risk