Convergent validity of EQ-5D with core outcomes in dementia: a systematic review.

OBJECTIVES: To explore through a systematic review, the convergent validity of EQ-5D (EQ-5D-3L and EQ-5D-5L (total score and dimensions)) with core outcomes in dementia and investigate how this may be impacted by rater-type; with the aim of informing researchers when choosing measures to use in dementia trials. METHODS: To identify articles relevant to the convergent validity of EQ-5D with core dementia outcomes, three databases were electronically searched to September 2022. Studies were considered eligible for inclusion within the review if they included individual level data from people with dementia of any type, collected self and/or proxy reported EQ-5D and collected at least one core dementia outcome measure. Relevant data such as study sample size, stage of dementia and administration of EQ-5D was extracted, and a narrative synthesis was adopted. RESULTS: The search strategy retrieved 271 unique records, of which 30 met the inclusion criteria for the review. Twelve different core outcome measures were used to capture dementia outcomes: cognition, function, and behaviour/mood across the studies. Most studies used EQ-5D-3L (n = 27). Evidence related to the relationship between EQ-5D and measures of function and behaviour/mood was the most robust, with unanimous directions of associations, and more statistically significant findings. EQ-5D dimensions exhibited associations with corresponding clinical outcomes, whereby relationships were stronger with proxy-EQ-5D (than self-report). CONCLUSION: Measuring health-rated quality of life in dementia populations is a complex issue, particularly when considering balancing the challenges associated with both self and proxy report. Published evidence indicates that EQ-5D shows evidence of convergent validity with the key dementia outcomes, therefore capturing these relevant dementia outcomes. The degree of associations with clinical measures was stronger when considering proxy-reported EQ-5D and differed by EQ-5D dimension type. This review has revealed that, despite the limited targeted psychometric evidence pool and reliance on clinical and observational studies, EQ-5D exhibits convergent validity with other dementia outcome measures.

Assessing the psychometric performance of EQ-5D-5L in dementia: a systematic review.

BACKGROUND: EQ-5D is widely used for valuing changes in quality of life for economic evaluation of interventions for people with dementia. There are concerns about EQ-5D-3L in terms of content validity, poor inter-rater agreement and reliability in the presence of cognitive impairment, but there is also evidence to support its use with this population. An evidence gap remains regarding the psychometric properties of EQ-5D-5L. OBJECTIVES: To report psychometric evidence around EQ-5D-5L in people with dementia. METHODS: A systematic review identified primary studies reporting psychometric properties of EQ-5D-5L in people with dementia. Searches were completed up to November 2020. Study selection, data extraction and quality assessment were undertaken independently by at least 2 researchers. RESULTS: Evidence was extracted from 20 articles from 14 unique studies covering a range of dementia severity. Evidence of known group validity from 5 of 7 studies indicated that EQ-5D-5L distinguishes severity of disease measured by cognitive impairment, depression, level of dependence and pain. Convergent validity (9 studies) showed statistically significant correlations of weak and moderate strengths, between EQ-5D-5L scores and scores on other key measures. Statistically significant change was observed in only one of 6 papers that allowed this property to be examined. All seven studies showed a lack of inter-rater reliability between self and proxy reports with the former reporting higher EQ-5D-5L scores than those provided by proxies. Five of ten studies found EQ-5D-5L to be acceptable, assessed by whether the measure could be completed by the PwD and/or by the amount of missing data. As dementia severity increased, the feasibility of self-completing EQ-5D-5L decreased. Three papers reported on ceiling effects, two found some evidence in support of ceiling effects, and one did not. CONCLUSIONS: EQ-5D-5L seems to capture the health of people with dementia on the basis of known-group validity and convergent validity, but evidence is inconclusive regarding the responsiveness of EQ-5D-5L. As disease progresses, the ability to self-complete EQ-5D-5L is diminished.

Cost-effectiveness evidence for strategies to promote or support breastfeeding: a systematic search and narrative literature review.

BACKGROUND: Global health policy recommends exclusive breastfeeding until infants are 6 months. Little is known about the cost-effectiveness of breastfeeding promotion strategies. This paper presents a systematic search and narrative review of economic evaluations of strategies to support or promote breastfeeding. The aim of the review is to bring together current knowledge to guide researchers and commissioners towards potentially cost-effective strategies to promote or support breastfeeding. METHODS: Searches were conducted of electronic databases, including MEDLINE and Scopus, for economic evaluations relevant to breastfeeding, published up to August 2019. Records were screened against pre-specified inclusion/exclusion criteria and quality was assessed using a published checklist. Costs reported in included studies underwent currency conversion and inflation to a single year and currency so that they could be compared. The review protocol was registered on the PROSPERO register of literature reviews (ID, CRD42019141721). RESULTS: There were 212 non-duplicate citations. Four were included in the review, which generally indicated that interventions were cost-effective. Two studies reported that breastfeeding promotion for low-birth weight babies in critical care is associated with lower costs and greater health benefits than usual care and so is likely to be cost-effective. Peer-support for breastfeeding was associated with longer duration of exclusivity with costs ranging from £19-£107 per additional month (two studies). CONCLUSIONS: There is limited published evidence on the cost-effectiveness of strategies to promote breastfeeding, although the quality of the current evidence is reasonably high. Future studies should integrate evaluations of the effectiveness of strategies with economic analyses.

Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis, people experiencing other mental health problems and for informal carers: Narrative Experiences Online (NEON) study protocol for three randomised controlled trials.

BACKGROUND: Mental health recovery narratives have been defined as first-person lived experience accounts of recovery from mental health problems which refer to events or actions over a period of time and which include elements of adversity or struggle, and also self-defined strengths, successes or survival. They are readily available in invariant recorded form, including text, audio or video. Previous studies have provided evidence that receiving recorded recovery narratives can provide benefits to recipients. This protocol describes three pragmatic trials that will be conducted by the Narrative Experiences Online (NEON) study using the NEON Intervention, a web application that delivers recorded recovery narratives to its users. The aim of the NEON Trial is to understand whether receiving online recorded recovery narratives through the NEON Intervention benefits people with experience of psychosis. The aim of the NEON-O and NEON-C trials is to evaluate the feasibility of conducting a definitive trial on the use of the NEON Intervention with people experiencing non-psychosis mental health problems and those who care for others experiencing mental health problems respectively. METHODS: The NEON Trial will recruit 683 participants with experience of psychosis. The NEON-O Trial will recruit at least 100 participants with experience of non-psychosis mental health problems. The NEON-C Trial will recruit at least 100 participants with experience of caring for others who have experienced mental health problems. In all three trials, participants will be randomly allocated into one of two arms. Intervention arm participants will receive treatment as usual plus immediate access to the NEON Intervention for 1 year. Control arm participants will receive treatment as usual plus access to the NEON Intervention after 1 year. All participants will complete demographics and outcome measures at baseline, 1 week, 12 weeks and 52 weeks. For the NEON Trial, the primary outcome measure is the Manchester Short Assessment of Quality of Life at 52 weeks, and secondary outcome measures are the CORE-10, Herth Hope Index, Mental Health Confidence Scale and Meaning in Life Questionnaire. A cost-effectiveness analysis will be conducted using data collected through the EQ-5D-5 L and the Client Service Receipt Inventory. DISCUSSION: NEON Trial analyses will establish both effectiveness and cost-effectiveness of the NEON Intervention for people with experience of psychosis, and hence inform future clinical recommendations for this population. TRIAL REGISTRATION: All trials were prospectively registered with ISRCTN. NEON Trial: ISRCTN11152837 . Registered on 13 August 2018. NEON-C Trial: ISRCTN76355273 . Registered on 9 January 2020. NEON-O Trial: ISRCTN63197153 . Registered on 9 January 2020.

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial.

OBJECTIVES: Hearing, vision, and cognitive impairment commonly co-occur in older adults. Improving sensory function may positively impact outcomes in people with dementia (PwD). We developed a "sensory intervention" (SI) to support hearing and vision in PwD. Here, we report the findings of an international open-label field trial, and nested case series, to explore the impact of the SI on dementia-related outcomes. METHODS: This was a home-based trial conducted in France, England, and Cyprus. Participants were people with mild-to-moderate dementia and hearing and/or vision impairment (n = 19) and their study partners (unpaid carers; n = 19). The "basic" SI included a hearing and vision assessment and provision of glasses and/or hearing aids. A subsample received the "extended" SI with additional weekly visits from a sensory support therapist (SST). Exploratory analyses of dementia-related, health utility and resource utilisation outcomes were performed. RESULTS: Quality of life (QoL) and sensory functional ability improved. Change in QoL exceeded the threshold for a minimum clinically important difference. There was a modest improvement (in absolute terms) post intervention in behavioural disturbance, self-efficacy, and relationship satisfaction. Study partner time assisting instrumental activities of daily living (iADL) and supervision decreased by about 22 and 38 hours per month, respectively, although time for personal ADL support increased. Qualitative data supported effectiveness of the intervention: PwD were more socially engaged, less isolated, less dependent on study partners, and had improved functional ability and communication. CONCLUSIONS: These findings support the need for a definitive randomised controlled trial (RCT) to evaluate the effectiveness of the intervention.

Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE-Cog Field Trial.

OBJECTIVES: People with dementia (PwD) frequently experience hearing and vision impairment that is underrecognized and undertreated, resulting in reduced quality of life. Managing these impairments may be an important strategy to improve outcomes in PwD. Our objective was to field-trial a multifaceted sensory intervention (SI) to enhance hearing and vision in PwD. DESIGN: An international single-arm open-label feasibility, acceptability, and tolerability study. SETTING: Home-based setting in the United Kingdom, France, and Cyprus. PARTICIPANTS: Adults aged 60 years and older with mild-to-moderate dementia and uncorrected or suboptimally corrected hearing and/or vision impairment, and their study partners (n = 19 dyads). INTERVENTION: A sensory intervention (SI), comprising assessment of hearing and vision, fitting of corrective devices (glasses, hearing aids), and home-based support from a sensory support therapist for device adherence and maintenance, communication training, referral to support services, environmental sensory modification, and optimization of social inclusion. MEASUREMENTS: Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews. RESULTS: We successfully delivered all intervention components, and these were received and enacted as intended in all those who completed the intervention. No serious adverse events were reported. Acceptability (ie, understanding, motivation, sense of achievement) and tolerability (ie, effort, fatigue) ratings of the intervention were within a priori target ranges. We met recruitment and retention (93.8%) targets in two of the three sites. Participants completed more than 95% of diary entries, representing minimal missing data. Delays in the logistics circuit for the assessment and delivery of hearing aids and glasses were identified, requiring modification. The need for minor modifications to some outcome measures and the inclusion criteria were identified. CONCLUSION: This is the first study combining home-based hearing and vision remediation in PwD. The positive feasibility, acceptability, and tolerability findings suggest that a full-scale efficacy trial, with certain modifications, is achievable.