Development of the Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology: a qualitative synthesis of interventions in randomised controlled trials.

INTRODUCTION: Community-based services to sustain independence for older people have varying configurations. A typology of these interventions would improve service provision and research by providing conceptual clarity and enabling the identification of effective configurations. We aimed to produce such a typology. METHOD: We developed our typology by qualitatively synthesising community-based complex interventions to sustain independence in older people, evaluated in randomised controlled trials (RCTs), in four stages: (i) systematically identifying relevant RCTs; (ii) extracting descriptions of interventions (including control) using the Template for Intervention Description and Replication; (iii) generating categories of key intervention features and (iv) grouping the interventions based on these categories. PROSPERO registration: CRD42019162195. RESULTS: Our search identified 129 RCTs involving 266 intervention arms. The Community-based complex Interventions to sustain Independence in Older People (CII-OP) typology comprises 14 action components and 5 tailoring components. Action components include procedures for treating patients or otherwise intended to directly improve their outcomes; regular examples include formal homecare; physical exercise; health education; activities of daily living training; providing aids and adaptations and nutritional support. Tailoring components involve a process that may result in care planning, with multiple action components being planned, recommended or prescribed. Multifactorial action from care planning was the most common tailoring component. It involves individualised, multidomain assessment and management, as in comprehensive geriatric assessment. Sixty-three different intervention types (combinations) were identified. CONCLUSIONS: Our typology provides an empirical basis for service planning and evidence synthesis. We recommend better reporting about organisational aspects of interventions and usual care.

Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review.

OBJECTIVES: To report our experience using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). STUDY DESIGN AND SETTING: Two reviewers independently applied RoB 2 to results of interest in a large systematic review of complex interventions and reached consensus. We recorded the time taken, and noted and discussed our difficulties using the tool, and the resolutions we adopted. We explored the time taken with regression analysis and summarized our experience of implementing the tool. RESULTS: We assessed risk of bias in 860 results of interest in 113 studies. Staff resource averaged 358 minutes per study (SD 183). Number of results (ß = 22) and reports (ß = 14) per study and experience of the team (ß = -6) significantly affected assessment time. To implement the tool consistently, we developed cut points for missingness and considerations of balance regarding missingness, assumed some concerns with intervention deviations unless otherwise prevented or investigated, some concerns with measurements from unblinded self-reporting participants, and judged low risk of selection for certain dichotomous outcomes despite the absence of an analysis plan. CONCLUSION: The RoB 2 tool and guidance are useful but resource-intensive and challenging to implement. Critical appraisal tools and reporting guidelines should detail risk of bias implementation. Improved guidance focusing on implementation could assist reviewers.