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. 2023 Jan 31;2023(1):CD005562. doi: 10.1002/14651858.CD005562.pub3

Leroi 2019.

Study characteristics
Methods RCT
Participants N = 61
Parkinson's disease dementia (PDD); dementia with Lewy bodies (DLB) according to standard clinical diagnostic criteria
Median age (whole sample) 75 (range 55‐90)
Community
Interventions Individual cognitive stimulation adapted for Parkinson's disease (delivered by informal carers) (CST‐PD) (N = 31)
Treatment‐as‐usual controls (N = 30)
Outcomes Cognition: ACE‐III; Dementia Cognitive Fluctuation Scale
Quality of Life: EQ‐5D; Parkinson's Disease Questionnaire‐39
Quality of relationship: Relationship Satisfaction Scale
Mood: Hospital Anxiety & Depression Scale; Lille Apathy Rating Scale; Brief Resilience Scale
ADL: The Pill Questionnaire (specific ADL task)
Interpersonal Reactivity Index
Behaviour problems: NPI
Caregiver outcomes: Hospital Anxiety & Depression Scales; EQ‐5D; Short Form‐12 Health Survey (SF‐12); Relationship Satisfaction Scale; Dyadic Relationship Scale; Zarit Burden Interview; Relatives Stress Scale; Family Caregiving Role Scale; Brief Resilience Scale
Notes 30 minutes, 2‐3 times a week for 12 weeks
Study also included mild cognitive impairment in Parkinson's disease (PD‐MCI); study authors have provided data for PDD and DLB separately for this review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "an independent arbiter, applied a single‐stratum, blocked randomization to CST‐PD or TAU at a 1:1 level by participant–dyad".
Allocation concealment (selection bias) Low risk Independent process: "A tamper proof process of single‐strata, blocked randomisation will be applied and communicated via telephone and confirmatory email by an independent arbiter" (trial protocol).
Blinding of outcome assessment (detection bias)
All outcomes Low risk Clearly blinded:"'Procedures were in place to conceal the allocation from the independent, blinded outcome raters".
Incomplete outcome data (attrition bias)
All outcomes Unclear risk In the additional data provided by the study authors for e.g. the main cognition outcome (ACE‐III), 10/28 were missing at post‐treatment (cf. 3/28 for the control group). Analyses were for complete case only, so unclear what effect this might have
Selective reporting (reporting bias) Low risk Results for all outcomes were reported.
Other bias ‐ training and supervision Low risk Care partners received training and support to deliver the intervention.
Other bias ‐ treatment manual Low risk Manual developed (from iCST manual, Yates 2014) for the study