What is important to people living with dementia?: the ‘long-list’ of outcome items in the development of a core outcome set for use in the evaluation of non-pharmacological community-based health and social care interventions

Abstract

Background Core outcome sets (COS) prioritise outcomes based on their importance to key stakeholders, reduce reporting bias and increase comparability across studies. The first phase of a COS study is to form a ‘long-list’ of outcomes. Key stakeholders then decide on their importance. COS reporting is described as suboptimal and this first phase is often under-reported. Our objective was to develop a ‘long-list’ of outcome items for non-pharmacological interventions for people with dementia living at home. Methods Three iterative phases were conducted. First, people living with dementia, care partners, health and social care professionals, policymakers and researchers ( n = 55) took part in interviews or focus groups and were asked which outcomes were important. Second, existing dementia trials were identified from the ALOIS database. 248 of 1009 pharmacological studies met the inclusion criteria. Primary and secondary outcomes were extracted from a 50% random sample ( n = 124) along with eight key reviews/qualitative papers and 38 policy documents. Third, extracted outcome items were translated onto an existing qualitative framework and mapped into domains. The research team removed areas of duplication and refined the ‘long-list’ in eight workshops. Results One hundred seventy outcome items were extracted from the qualitative data and literature. The 170 outcome items were consolidated to 54 in four domains (Self-Managing Dementia Symptoms, Quality of Life, Friendly Neighbourhood & Home, Independence). Conclusions This paper presents a transparent blueprint for ‘long-list’ development. Though a useful resource in their own right, the 54 outcome items will be distilled further in a modified Delphi survey and consensus meeting to identify core outcomes.

A survey of the experience of living with dementia in a dementia-friendly community

“…Although the researchers cannot be certain that the supporter did not influence the participant's answers, allowing this support enabled the researchers to capture the voice of a large percentage of people living with dementia who would otherwise be excluded from sharing their experience. The results from this study complement the work of other studies that have developed outcome measures with people living with dementia (e.g., Harding et al, 2019) and resonates with their findings.…”

What is important to people with dementia living at home? A set of core outcome items for use in the evaluation of non-pharmacological community-based health and social care interventions

“…To date, this study has included 62 instances of people living with dementia being involved (17 participants in phase 1 and 18 consulted as co-researchers when designing the accessible Delphi process, 21 participated in the Delphi survey and 6 in the consensus meeting) [ 23 , 25 ]. We ensured that the views and opinions of people living with dementia were given equal weight when compared with those from other stakeholder groups.…”

“…The initial phase of the study involved extracting outcome items of importance from 35 face-to-face and telephone interviews and four focus groups with 55 participants (people living with dementia n = 17; care partners n = 18; health and social care professionals n = 15; policy makers n = 4; researchers n = 1) and a literature review of existing research, key reviews and policy documents. We initially produced a long list of 170 outcome items which we distilled into 54 outcome items in four conceptual categories (friendly neighbourhood and home, independence, self-managing dementia symptoms, quality of life) [ 25 ]. The second phase includes a modified Delphi approach and a consensus meeting and is outlined in this paper.…”

Fall‐Related Hospitalizations in Nursing Home Residents Co‐Prescribed a Cholinesterase Inhibitor and Beta‐Blocker

“…Although the FDA medication review for galantamine was conducted in 2001 and risk of falling was prioritized by caregivers and persons with dementia, the risk of falling associated with ChEI use in persons with cognitive impairment has not been extensively studied, and this risk is poorly reported in RCTs. 9,[15][16][17][18] A recent meta-analysis of RCTs, including persons with dementia or mild cognitive impairment who were randomized to receive a ChEI or placebo, did not demonstrate an increased risk of falling associated with ChEI use in persons with dementia; however, another meta-analysis highlighted that risk of falling was not reported in the primary publication for 10 RCTs of ChEIs, which creates uncertainty about the reliability of adverse event data reported in trials of medications. 17,18 Risk of falling is an important outcome to persons with dementia and their caregivers, so ongoing studies looking at individual drug risks and drug-drug interactions with population-based data, such as we presented in this study, are critical.…”

“…42 We urge clinicians to discuss our findings when engaging in shared decision making, especially given the importance placed on risk of falling as a core outcome identified by persons with dementia and caregivers. 15…”