A list of tools is NOT enough! Professionals’ advice on how to implement a Core Outcome Set in practice

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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

BackgroundCore 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. MethodsThree 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. ResultsOne 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). ConclusionsThis 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

Collaborative care intervention for individuals with severe mental illness: the PARTNERS2 programme including complex intervention development and cluster RCT

Background and aims: Individuals living with severe mental illness such as schizophrenia and bipolar can have significant emotional, cognitive, physical and social challenges. Most people with severe mental illness in the United Kingdom do not receive specialist mental health care. Collaborative care is a system of support that combines clinical and organisational components to provide integrated and person-centred care. It has not been tested for severe mental illness in the United Kingdom. We aimed to develop and evaluate a primary care-based collaborative care model (PARTNERS) designed to improve quality of life for people with diagnoses of schizophrenia, bipolar or other psychoses when compared with usual care. Methods: Phase 1 included studies to (1) understand context: an observational retrospective study of primary and secondary care medical records and an update of the Cochrane review ‘Collaborative care approaches for people with severe mental illness’; (2) develop and formatively evaluate the PARTNERS intervention: a review of literature on collaborative care and recovery, interviews with key leaders in collaborative care and recovery, focus groups with service users and a formative evaluation of a prototype intervention model; and (3) develop trial science work in this area: a core outcome set for bipolar and recruitment methods. In phase 2 we conducted a cluster randomised controlled trial measuring quality of life using the Manchester Short Assessment of Quality of Life and secondary outcomes including time use, recovery and mental well-being; a cost-effectiveness study; and a mixed-methods process evaluation. Public involvement underpinned all of the workstream activity through the study Lived Experience Advisory Panel and the employment of service user researchers in the project team. Results phase 1: The study of records showed that care for individuals under secondary care is variable and substantial and that people are seen every 2 weeks on average. The updated Cochrane review showed that collaborative care interventions were highly variable, and no reliable conclusions can be drawn about effectiveness. The PARTNERS model incorporated change at organisational, practitioner and individual levels. Coaching was selected as the main form of support for individuals’ personal goals. In the formative evaluation, we showed that more intensive supervision and ‘top-up’ training were needed to achieve the desired shifts in practice. A core outcome set was developed for bipolar, and measures were selected for the trial. We developed a stepped approach to recruitment including initial approach and appointment. Results phase 2: The trial was conducted in four areas. In total, 198 participants were recruited from 39 practices randomised. Participants received either the PARTNERS intervention or usual care. The follow-up rate was 86% at 9–12 months. The mean change in overall Manchester Short Assessment Quality of Life score did not differ between the groups [0.25 (standard deviation 0.73) for intervention vs. 0.21 (standard deviation 0.86) for control]. We also found no difference for any secondary measures. Safety outcomes (e.g. crises) did not differ between those receiving and those not receiving the intervention. Although the costs of intervention and usual care were similar, there is insufficient evidence to draw conclusions about the overall cost-effectiveness of PARTNERS. The mixed-methods process evaluation demonstrated that a significant proportion of individuals did not receive the full intervention. This was partly due to care partner absence and participant choice. The in-depth realist informed case studies showed that participants generally appreciated the support, with some describing having a ‘professional friend’ as very important. For some people there was evidence that delivery of the intervention had led to specific personal changes. Strengths and limitations: The phase 1 records study provided insights into usual care that had not been previously documented. The realist informed complex intervention development was both theoretical and pragmatic. The trial continued through the COVID-19 pandemic with high levels of follow-up. The process evaluation had the depth to explore individual changes in participants’ response to the intervention. Weaknesses in the trial methodology included suboptimal implementation, outcome measures that may not have been sensitive to changes patients most appreciated and difficulties collecting some outcomes. Conclusions: While PARTNERS was not shown to be superior to usual care, the change to PARTNERS care was not shown to be unsafe. Full intervention implementation was challenging, but this is to be expected in studies of care that include those with psychosis. Some individuals responded well to the intervention when psychological support in the form of individualised goal setting was flexibly deployed, with evidence that having access to a ‘professional friend’ was experienced as particularly helpful for some individuals. Future work: Key components of the PARTNERS model could be developed further and tested, along with improved supervision in the context of ongoing community mental health care change. Trial registration: This trial is registered as ISRCTN95702682

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Prevalence, awareness, and associated risk factors of hypertension in older adults in Africa:a systematic review and meta-analysis protocol

BACKGROUND: The health of older persons has not been a major priority in many African countries. Hypertension is one of the common health problems of older persons. However, there is little information on the prevalence of hypertension in older adults in Africa. This is in spite of the fact that Africa has the highest age-standardized prevalence of hypertension in the world. We therefore present this protocol to conduct a systematic review and meta-analysis on the prevalence of hypertension and the level of its awareness among older persons living in Africa. METHODS: Major databases (EMBASE, MEDLINE, Academic Search Complete, CINAHL, PsycINFO) and unpublished literature will be searched to identify population-based studies on hypertension in adults aged 50 years and older living in Africa. Eligible articles are those which use the 140/90-mmHg cutoff to diagnose hypertension and were published from 1980 to present. We will exclude subjects in restricted environments such as patients and refugees. Articles will be independently evaluated by two reviewers to determine if they meet the inclusion criteria. They will also evaluate the quality of included studies using a validated tool by Hoy and colleagues for prevalence studies. The main outcome is the prevalence of hypertension while the explanatory variables include demographic, socio-economic, dietary, lifestyle and behavioural factors. Effect sizes in bivariate and multivariate analyses will be presented as odds or prevalence ratios. We will explore for heterogeneity of the standard errors across the studies, and if appropriate, we will perform a meta-analysis using a random-effects model to present a summary estimate of the prevalence of hypertension in this population. DISCUSSION: The estimates of the prevalence, the risk factors and the level of awareness of hypertension could help in galvanizing efforts at prioritizing the cardiovascular health of older persons in Africa. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017056474

What is Important to People with Dementia Versus Trial Outcomes:A Neighbourhoods and Dementia Study

The outcomes assessed in non-pharmacological interventions for people with dementia vary, making it difficult to compare their effectiveness. This study, part of the Neighbourhoods and Dementia programme, seeks to create a core outcome set for use within intervention studies and has a rigorous 4-phase study design: qualitative interviews/focus groups and literature review; Delphi survey; systematic review; and stated preference survey. This presentation will focus on Phase 1, comparing outcomes identified through the qualitative work to those measured by previous non-pharmacological intervention trials. Thirty-one interviews and four focus groups were conducted with people with dementia, care partners, health and social care professionals, and policy makers, service commissioners and research leaders and the outcome measures extracted from 129 studies. The interviews and focus group were analysed using a thematic framework to identify outcomes considered important to people with dementia from their own perspective and the other stakeholders’ perspectives. Comparing the outcomes identified in the literature to those from the qualitative data revealed differences in the emphasis of the outcomes, indicating that the outcomes previously used to evaluate interventions do not necessarily reflect what is important to people with dementia. For example, within previous studies activities were assessed in terms of frequency; however, in the interviews it became clear that the meaningfulness of the activities rather than the frequency is important. Creating this core outcome set to evaluate non-pharmacological interventions will enable better comparison of the effectiveness of the intervention and ensure that the outcomes considered are important to people with dementia

Involving people living with dementia in research:an accessible modified Delphi survey for core outcome set development

Background Recent recommendations promote the inclusion of people living with dementia beyond the role of ‘participant’ to involvement in all areas of the research process. This reflects shifts in dementia studies from ‘research on’ to ‘research with’ people living with the condition. In this paper, we describe the design process and features of a modified Delphi survey devised through consultation with people living with dementia. Methods This article focusses on consultation with people living with dementia and care partners to design an accessible Delphi survey to facilitate participation in core outcome set development. We used the COINED model of co-research developed through the ESRC/NIHR Neighbourhoods and Dementia Study to structure consultation on three features of modified Delphi design. Consultation was achieved through 1:1 and group sessions with a total of 28 individuals (18 people living with dementia and seven care partners). Results A flexible, responsive and adaptive approach to ongoing consultation with people living with dementia and care partners through 1:1 face-to-face sessions facilitated: (1) the development of a 3-point non-categorical importance scale; (2) the translation of 54 outcome areas into ‘accessible statements’ for a two-round Delphi survey administered to five stakeholder groups (people living with dementia, care partners, health and social care professionals, policy-makers and researchers); and (3) the delivery of a Delphi survey. These features of core outcome set development facilitated the involvement of people living with dementia in study design and as research participants in the data collection phase. Conclusions Involvement of people living with dementia as a key stakeholder group is not reflected in studies using Delphi survey methods for core outcome set development. Time, resources, researcher expertise and support, underpinned through targeted funding facilitate meaningful and productive inclusive approaches, now an expectation of dementia research