Methodology and outcome of trials involving older adults in UK care homes: A rapid review.

Background: The United Kingdom (UK) has a well-developed health and social care system, and strong research governance. However, there is limited evidence to guide best research practice among vulnerable older people in care homes and there is no consensus on clinical trial methodology that is deliverable in this setting.

Objectives: To review the literature on trials conducted among older adults residing in care homes within the UK and collate evidence on their methodological characteristics and outcomes.

Methods: A systematic rapid review methodology was employed. MEDLINE, EMBASE and CENTRAL were searched in two incremental stages: stage 1 searched for oral health-related trials conducted within the UK care homes up to July 2021, whereas stage 2 sought for general health-related trials in the same setting from 2011 to 2021. The quality of included studies was assessed using Cochrane's RoB 2 and ROBINS-I tools. Findings were summarised descriptively.

Results: Five oral health and 33 general health-related trials involving care home residents were included for analysis. The most common trial design was parallel group with two arms (n = 25) involving individual randomisation (n = 21). Consent was mainly obtained from residents and/or their proxies (n = 24), followed by residents only (n = 13) and care homes only (n = 1). Based on available data, the number needed to screen to recruit one participant ranged from 2 to 40 (median: 3; Q1-Q3: 2-9). Attrition rates ranged from 0% to 73% (median: 21%; Q1-Q3: 13%-32%) for follow-up periods between 1 and 52 weeks. The studies were of mixed methodological quality.

Conclusion: This rapid review outlines the methodological characteristics and outcomes of trials conducted among older adults in UK care homes. The findings of this review provide valuable information to assist in navigating and designing future research in this complex setting.