Challis 2002.

Methods	A controlled clinical trial with follow‐up at 6 months and 12 months. Collaborating partners Lead agency: Community mental health Strategic involvement (policy making and service planning): No evidence of collaborating at the strategic level. Commissioning (implementing strategy taking account of resources available): Secondary health care, social services. Operational (providing services directly): Primary health care, secondary health care, social services. Set in United Kingdom.
Participants	The study looked at elderly adults with dementia in Lewisham, South London. Forty‐five cases in the intervention group and 50 controls were assessed over a two year period. From these, 43 matched pairs were identified to compare destinational outcome and costs.  30.2% male, mean age 80.8 (intervention)/79.8 yrs (control). Subjects were identified by two community mental health teams for the elderly (CMHTE) as new referrals or cases with a major change in circumstances, or with significant needs unmet by existing services, or perceived as at risk of institutionalisation. Over 70% had severe cognitive impairment and high/maximum disability. 80% had a carer and half of the carers were suffering marked stress.
Interventions	Individuals in the intervention arm received care from Lewisham Case Management Scheme, an intensive case management scheme with case managers in a CMHTE caring for a target population of older people with dementia. Case managers were social services employees with protected case loads of 20‐25 cases and control over a devolved budget. They were integrated into the mental health team and had access to all relevant health and social care resources for the care of older people with dementia. They maintained structured care plans which were completed at regular intervals during the 2 years of the study. Individuals in the control arm received care from a CMHTE without a case management service.
Outcomes	No primary outcome stated. Assessment of need and quality of life was conducted at 6 and 12 months. Destinational outcomes (still being at home, being placed in a care home or dying) were measured every 6 months for 2 years. Quality of life was measured through the CARE schedule to measure depression, disability through CAPE Behaviour Rating Scale for physical disability, social disturbance, communication disorder and apathy. Quality of care was measured through CAPE, assessing dependency. Overall need ratings and level of risk judged by research assessors. Carers' health was assessed through the Malaise scale as a global indicator of stress.
Notes	No power calculation was reported. Main changes 44% extra for home care, 24% for extra professional care including case management, 27% acute hospital care. Mean costs per annum: £23,402 for intervention group, £19,053 for control group. Additional resources required could account for any benefits achieved. Majority of additional costs were incurred by Social Services (£8815 per patient per year intervention group/ £4676 per patient per year in control) Overall risk of bias was high.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk	Groups were not randomised. One community health team received the intervention and another acted as control.
Blinding (performance bias and detection bias) All outcomes	High risk	Not possible due to nature of allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Full outcome data provided for 43 matched pairs (86 of the 95 cases included).
Selective reporting (reporting bias)	High risk	Different outcomes reported at different follow‐up periods.
Other bias	High risk	Patients were identified for inclusion in the study by their clinicians
Randomisation adequately described/protected?	High risk	No randomisation
Protection against contamination?	Low risk	Separate settings so contamination unlikely.
Follow‐up rate adequate?	Low risk	>80% and balanced across both arms but rate varied between individual outcomes.
Reliable primary outcome measure?	Low risk	No primary outcome stated but reliable measures used to assess health outcomes.
Groups measured at baseline?	Low risk	Groups approximately balanced
Appropriate choice of controls (CBA studies only)?	Unclear risk	Not applicable
Contemporaneous data collection (CBA studies only)?	Unclear risk	Not applicable
IS THE STUDY AT LOW RISK OF BIAS?	High risk	OVERALL RISK OF BIAS WAS HIGH