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

Battersby 2007.

Methods Study design: 8 studies in 4 regions, including 4 RCTs (the others used geographic controls).
Unit of randomisation: patient
Unit of analysis: patient
Funding sources: South Australian Health Commission; Commonwealth Department of Health and Aged Care
Conflicting interests: none declared
Participants Country: Australia
Setting: Primary care
Conditions/numbers: 1703 patients with various conditions: Central region: cardiac (n = 271 intervention, 138 control); Southern region: respiratory (n = 165 intervention, 62 control), somatisation (n = 90 intervention, 35 control), aged care (n = 632 intervention, 310 control) ‐ total 1158 intervention, 545 control. (Battersby 2005 p. 663)
Health literacy: n/a
Multi‐morbidity: n/a
Interventions Theoretical framework: Chronic Care Model
Focus: Both clinician and patient
Type of intervention: Structured, face‐to‐face planning and care co‐ordination + staff training
Clinicians involved: Service co‐ordinators (nurses + allied health professionals ‐ additional) and regular GP
Tools: SA HealthPlus Co‐ordinated Care. Service co‐ordinator assisted the GP to develop a care plan based on a care plan generator. This included patient's self‐defined problems and goals. Based on this and the GP's knowledge of the patient, as well as the patient's 'Problems & Goals' statements, the GP and patient made a joint decision on what support and services were needed. Both the GP and the patient signed the care plan, and copies were made for patient, service co‐ordinator, other providers and GP. Service co‐ordinators received 2 days training + competency assessment and group supervision. The service co‐ordinator helped the patient gain access to and co‐ordinate community and patient education services and worked with the patient to achieve his or her goals.GPs were paid a fee to develop each care plan and an annual fee to oversee patients' care, supported by the service co‐ordinators.
Stages completed: Extended ‐ A, B,C,D,E,F,G
Usual provider aware of patient's goals and action plans: Yes
Standardisation of clinician input: Good (training and ongoing supervision), but "The [intervention group] GPs needed reminders to order the services scheduled on the care plan." (p. 62)
Fidelity: Weak. "The intervention was not in place long enough for its full implementation" (p. 62)
Attrition: High. More than 50% of participants lost to follow‐up following trial extension (p. 48)
Comparison: Usual care
Outcomes Health status:subjective: Medical Outcomes Study short form (SF‐36), Work and Social Adjustment Scale (WSAS); psychological: Beck Depression Inventory (BDI), State‐Trait Anxiety Inventory (STAI), Hostility and Direction of Hostility Questionnaire (HDHQ) (Pols 2008)
Self‐management capabilities: n/a
Health behaviours: n/a
Attainment of personal goals: problems and goals score
Service use: *service use and costs
Adverse events: none reported
Timing of outcome measures: 12 months; baseline measures not reported
Notes *Primary outcome. Negative results not reported in full. Author contacted ‐ more papers supplied but no relevant additional data obtained. Data from one sub‐trial with complete results (Pols 2008) included in meta‐analysis. Pols 2008: power calculation ‐ required sample size of 300 participants to detect 15% reduction in hospital admissions but only 124 recruited, so under‐powered.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Pols 2008: randomisation performed by random number allocation (p. S133).
Allocation concealment (selection bias) Low risk Pols 2008: random number allocation provided to the research officer by telephone from the local evaluation team (p. S133).
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Pols 2008: GPs were not blinded to participant allocation. All GPs looked after participants in both intervention and control groups, (p. S133)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Pols 2008: research officers were not blinded to participant allocation, but outcome assessments were administered independently by separate contractors using postal questionnaires mailed to participants (p. S134)
Incomplete outcome data (attrition bias) 
 All outcomes High risk Pols 2008: High levels of attrition: only 42 out of 89 in the intervention group (47%) and 22 of 44 in the control group (50%) completed the study. Reasons for loss to follow‐up reported for study as a whole but not for the two randomised sub‐trials, so not possible to isolate these. Service use analysed on an intention‐to‐treat basis but not possible for SF‐36 and WSAS
Selective reporting (reporting bias) High risk Battersby 2007 reports significant results only for SF‐36 and WSAS, not non‐significant findings, and RCTs and those with geographical controls are lumped together. Battersby 2005 reports only significant results for SF‐36, not total scores or non‐significant results for subscales. Cost data include only those who had an inpatient admission prior to entry. These facts are made clear in the papers. Pols 2008 reports full results for SF‐36 but not for WSAS, but they state that there was no significant difference in results for WSAS (p. S136).
Other bias Unclear risk Work and Social Adjustment Scale has not been validated in a chronically ill population and the work questions were omitted because not relevant to most participants (p. 46).