Modelling Informal Carers' Health-Related Quality of Life: Challenges for Economic Evaluation.

There has been increasing interest in including carers' health-related qualify of life (HRQoL) in decision models, but currently there is no best practice guidance as to how to do so. Models thus far have typically assumed that carers' HRQoL can be predicted from patient health states, as we illustrate with three examples of disease-modifying treatments. However, this approach limits the mechanisms that influence carers' HRQoL solely to patient health and may not accurately reflect carers' outcomes. In this article, we identify and discuss challenges associated with modelling intervention effects on carers' HRQoL: attaching carer utilities to patient disease states, the size of the caring network, aggregation of carer and patient HRQoL, patient death, and modelling longer-term carer HRQoL. We review and critique potential alternatives to modelling carers' HRQoL in decision models: trial-based analyses, qualitative consideration, cost-consequence analysis, and multicriteria decision analysis, noting that each of these also has its own challenges. We provide a framework of issues to consider when modelling carers' HRQoL and suggest how these can be addressed in current practice and future research.

Recommendations for Emerging Good Practice and Future Research in Relation to Family and Caregiver Health Spillovers in Health Economic Evaluations: A Report of the SHEER Task Force.

BACKGROUND: Omission of family and caregiver health spillovers from the economic evaluation of healthcare interventions remains common practice. When reported, a high degree of methodological inconsistency in incorporating spillovers has been observed. AIM: To promote emerging good practice, this paper from the Spillovers in Health Economic Evaluation and Research (SHEER) task force aims to provide guidance on the incorporation of family and caregiver health spillovers in cost-effectiveness and cost-utility analysis. SHEER also seeks to inform the basis for a spillover research agenda and future practice. METHODS: A modified nominal group technique was used to reach consensus on a set of recommendations, representative of the views of participating subject-matter experts. Through the structured discussions of the group, as well as on the basis of evidence identified during a review process, recommendations were proposed and voted upon, with voting being held over two rounds. RESULTS: This report describes 11 consensus recommendations for emerging good practice. SHEER advocates for the incorporation of health spillovers into analyses conducted from a healthcare/health payer perspective, and more generally inclusive perspectives such as a societal perspective. Where possible, spillovers related to displaced/foregone activities should be considered, as should the distributional consequences of inclusion. Time horizons ought to be sufficient to capture all relevant impacts. Currently, the collection of primary spillover data is preferred and clear justification should be provided when using secondary data. Transparency and consistency when reporting on the incorporation of health spillovers are crucial. In addition, given that the evidence base relating to health spillovers remains limited and requires much development, 12 avenues for future research are proposed. CONCLUSIONS: Consideration of health spillovers in economic evaluations has been called for by researchers and policymakers alike. Accordingly, it is hoped that the consensus recommendations of SHEER will motivate more widespread incorporation of health spillovers into analyses. The developing nature of spillover research necessitates that this guidance be viewed as an initial roadmap, rather than a strict checklist. Moreover, there is a need for balance between consistency in approach, where valuable in a decision making context, and variation in application, to reflect differing decision maker perspectives and to support innovation.

Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial.

BACKGROUND: Depressive episodes are common after first-episode psychosis (FEP), affecting more than 40% of people, adding to individual burden, poor outcomes, and healthcare costs. If the risks of developing depression were lower, this could have a beneficial effect on morbidity and mortality, as well as improving outcomes. Sertraline is a selective serotonin reuptake inhibitor and a common first-line medication for the treatment of depression in adults. It has been shown to be safe when co-prescribed with antipsychotic medication, and there is evidence that it is an effective treatment for depression in established schizophrenia. We present a protocol for a multi-centre, double-blind, randomised, placebo-controlled clinical trial called ADEPP that aims to investigate the efficacy and cost-effectiveness of sertraline in preventing depression after FEP. METHODS: The recruitment target is 452 participants between the ages of 18 and 65 years who are within 12 months of treatment initiation for FEP. Having provided informed consent, participants will be randomised to receive either 50 mg of sertraline daily or matched placebo for 6 months, in addition to treatment as usual. The primary outcome measure will be a comparison of the number of new cases of depression between the treatment and placebo arms over the 6-month intervention phase. Secondary outcomes include suicidal behaviour, anxiety, rates of relapse, functional outcome, quality of life, and resource use. DISCUSSION: The ADEPP trial will test whether the addition of sertraline following FEP is a clinically useful, acceptable, and cost-effective way of improving outcomes following FEP. TRIAL REGISTRATION: ISRCTN12682719 registration date 24/11/2020.

Modelling Spillover Effects on Informal Carers: The Carer QALY Trap.

The provision of informal (unpaid) care can impose significant 'spillover effects' on carers, and accounting for these effects is consistent with the efficiency and equity objectives of health technology assessment (HTA). Inclusion of these effects in health economic models, particularly carer health-related quality of life (QOL), can have a substantial impact on net quality-adjusted life year (QALY) gains and the relative cost effectiveness of new technologies. Typically, consideration of spillover effects improves the value of a technology, but in some circumstances, consideration of spillover effects can lead to situations whereby life-extending treatments for patients may be considered cost ineffective due to their impact on carer QOL. In this piece we revisit the classic 'QALY trap' and introduce an analogous 'carer QALY trap' which may have practical implications for economic evaluations where the inclusion of carer QOL reduces incremental QALY gains. Such results may align with a strict QALY-maximisation rule, however we consider the extent to which this principle may be at odds with the preferences of carers themselves (and possibly society more broadly), potentially leading decision makers into the carer QALY trap as a result. We subsequently reflect on potential solutions, highlighting the important (albeit limited) role that deliberation has to play in HTA.

Smartphones, social Media and Adolescent mental well-being: the impact of school policies Restricting dayTime use-protocol for a natural experimental observational study using mixed methods at secondary schools in England (SMART Schools Study).

INTRODUCTION: Smartphone and social media use is prevalent during adolescence, with high levels of use associated with lower levels of mental well-being. Secondary schools in the UK have introduced policies that restrict daytime use of smartphones and social media, but there is no evaluation on the impact of these policies on adolescent mental well-being. The SMART Schools Study aims to determine the impact of daytime restrictions of smartphone and social media use on indicators of adolescent mental well-being, anxiety, depression, physical activity, sleep, classroom behaviour, attainment and addictive social media use. METHODS AND ANALYSIS: This is a natural experimental observational study using mixed methods. Secondary schools within a 100 mile radius of the recruiting centre in the West Midlands (UK) have been categorised into two groups: Schools that restrict (intervention) and permit (comparator) daytime use of smartphones. We aim to recruit 30 schools (20 restrictive, 10 permissive) and 1170 pupils aged 12-13 and 14-15 years. We will collect data on mental well-being, anxiety and depressive symptoms, phone and social media use, sleep and physical activity from pupil surveys, and accelerometers. Policy implementation measures and data on individual pupil factors will be collected through school staff surveys, and website/policy analysis. Six case study schools will explore individual, school and family/home factors that influence relationships between school smartphone policies, smartphone/social media use, and mental well-being. Economic evaluation will be completed through a cost-consequence analysis from an education sector perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Birmingham's Research Ethics Committee (ERN_22-0723). Parents/carers of pupil participants can complete a form to opt their child out of the study. Pupil, school staff and parent/carer participants are asked to complete online/written consent (or assent). Findings will be disseminated through policy briefings, resources for schools, social media, reports, and open access publications. TRIAL REGISTRATION NUMBER: ISRCTN77948572.

The Feasibility and Validity of Preference-Based Quality of Life Measures With Informal Carers: A Think-Aloud Study.

OBJECTIVES: A range of preference-based quality of life (QoL) measures have been proposed for use with informal carers. Qualitative evaluation of validity and feasibility of the measures is an important step in understanding whether measures will work as intended. At present, little is known about the performance of different types of preference-based QoL measures with informal carers. The objective of this study was to qualitatively assess the feasibility, content validity (including face validity), and acceptability of 5 QoL measures (the Carer Experience Scale, CarerQoL-7D, ASCOT-C, ICECAP-A, and EQ-5D-5L) with informal carers. METHODS: A total of 24 "think-aloud" interviews were conducted with a cross-section of carers of adults in the United Kingdom. This think-aloud process was followed by semistructured discussion to probe issues of validity and feasibility in more detail. The interview data were transcribed, coded to identify the frequency of errors in completing the QoL measures and thematically analyzed to study the validity, feasibility, and acceptability of the measures. RESULTS: Few errors (3%-7% per item) were identified in completing each of the measures with little distinct pattern. Most participants found the measures to be concise, clear, and relevant. Challenges included relevance, context, time period, missing items, multiple questions, and response options. Informal carers generally expressed a preference for using a care-related QoL measure. CONCLUSIONS: Existing preference-based QoL measures have encouraging validity and feasibility within a mixed sample of informal carers, with minor challenges raised. These challenges ought to be considered, alongside the decision context, when administering QoL measures in this context.

Unmet Parenthood Goals, Health-Related Quality of Life and Apparent Irrationality: Understanding the Value of Treatments for Infertility.

An increasing number of prospective parents are experiencing infertility along with associated negative impacts on mental health and life satisfaction that can extend across a network of individuals and family members. Assistive reproductive technologies (ART) can help prospective parents achieve their parenthood goals but, like any health technology, they must demonstrate acceptable 'value for money' to qualify for public funding. We argue that current approaches to understanding the value of ART, including quality-adjusted life-year (QALY) gains based on changes in health-related quality of life (HRQOL) and, more often, cost per live birth, are too narrow to capture the full impact of unmet parenthood goals and ART. We see a fundamental disconnect between measures of HRQOL and broader measures of wellbeing associated with met and unmet parenthood goals. We also suggest that simple concepts such as 'patient' and 'carer' are of limited applicability in the context of ART, where 'spillovers' extend across a wide network of individuals, and the person receiving treatment is often not the infertile individual. Consideration of individual and societal wellbeing beyond HRQOL is necessary to understand the full range of negative impacts associated with unmet parenthood goals and the corresponding positive impacts of successful ART. We suggest moving towards a wellbeing perspective on value to achieve a fuller understanding of value and promote cross-sector allocative efficiency.

Safeguarding adolescent mental health in India (SAMA): study protocol for codesign and feasibility study of a school systems intervention targeting adolescent anxiety and depression in India.

INTRODUCTION: Symptoms of anxiety and depression in Indian adolescents are common. Schools can be opportune sites for delivery of mental health interventions. India, however, is without a evidence-based and integrated whole-school mental health approach. This article describes the study design for the safeguarding adolescent mental health in India (SAMA) project. The aim of SAMA is to codesign and feasibility test a suite of multicomponent interventions for mental health across the intersecting systems of adolescents, schools, families and their local communities in India. METHODS AND ANALYSIS: Our project will codesign and feasibility test four interventions to run in parallel in eight schools (three assigned to waitlist) in Bengaluru and Kolar in Karnataka, India. The primary aim is to reduce the prevalence of adolescent anxiety and depression. Codesign of interventions will build on existing evidence and resources. Interventions for adolescents at school will be universal, incorporating curriculum and social components. Interventions for parents and teachers will target mental health literacy, and also for teachers, training in positive behaviour practices. Intervention in the school community will target school climate to improve student mental health literacy and care. Intervention for the wider community will be via adolescent-led films and social media. We will generate intervention cost estimates, test outcome measures and identify pathways to increase policy action on the evidence. ETHICS AND DISSEMINATION: Ethical approval has been granted by the National Institute of Mental Health Neurosciences Research Ethics Committee (NIMHANS/26th IEC (Behv Sc Div/2020/2021)) and the University of Leeds School of Psychology Research Ethics Committee (PSYC-221). Certain data will be available on a data sharing site. Findings will be disseminated via peer-reviewed journals and conferences.

The use of composite time trade-off and discrete choice experiment methods for the valuation of the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS): a think-aloud study.

PURPOSE: To identify patterns and problems in completing composite time trade-off (C-TTO) and discrete choice experiment (DCE) exercises for the valuation of the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) to inform the optimisation of a valuation protocol. METHODS: Fourteen cognitive interviews were conducted in the UK using concurrent and retrospective think-aloud and probing techniques. Each participant completed 8 C-TTO tasks and 8 DCE tasks within a computer-assisted personal interview setting. Verbal information was transcribed verbatim. Axial coding and thematic analysis were used to organise the qualitative data and identify patterns and problems with the completion of tasks. RESULTS: While participants found the tasks generally manageable, five broad themes emerged to explain and optimise the response to the tasks. (1) Format and structure: attention to the design of practice examples, instructions, and layout were needed. (2) Items and levels: underlying relationships were discovered across different combinations of levels of SWEMWBS items. (3) Decision heuristics: participants engaged in diverse strategies to assist trade-off decisions. (4) Valuation feasibility: certain states were difficult to imagine, compare and quantify. (5) Valuation outcome: the data quality was affected by participants' discriminatory ability across states and their time trade-off decisions. CONCLUSION: The interviews contributed insights regarding the robustness of the proposed methods. The application of C-TTO and DCE valuation techniques was practical and suitable for capturing individual attitudes towards different mental well-being scenarios. A modified protocol informed by the results is being tested in a larger sample across the UK.

Financial stress and depression in adults: A systematic review.

Financial stress has been proposed as an economic determinant of depression. However, there is little systematic analysis of different dimensions of financial stress and their association with depression. This paper reports a systematic review of 40 observational studies quantifying the relationship between various measures of financial stress and depression outcomes in adults. Most of the reviewed studies show that financial stress is positively associated with depression. A positive association between financial stress and depression is found in both high-income and low-and middle-income countries, but is generally stronger among populations with low income or wealth. In addition to the "social causation" pathway, other pathways such as "psychological stress" and "social selection" can also explain the effects of financial stress on depression. More longitudinal research would be useful to investigate the causal relationship and mechanisms linking different dimensions of financial stress and depression. Furthermore, exploration of effects in subgroups could help target interventions to break the cycle of financial stress and depression.

The relative value of carer and patient quality of life: A person trade-off (PTO) study.

Carer quality of life is increasingly considered alongside patient quality of life in economic evaluation. Important questions remain about how to value carer and patient quality of life effects alongside one another. In this study, we estimated the relative social value of two conceptualisations of carer quality of life (health-related and care-related) compared to patient quality of life. Relative valuations were estimated using a person trade-off (PTO) study with 990 representative members of the UK public. Participants chose between hypothetical services that improved the quality of life of carers and patients, iterating to a point of indifference. Overall 84% of participants completing the task were willing to trade patient and carer quality of life effects. Relative to a reference point of 1 for patient health-related quality of life, we estimated a social value of 0.74 for carer health-related quality of life effects and 0.69 for carer care-related quality of life effects. In conclusion, public preferences appear to support the inclusion of carer quality of life effects within economic evaluation. The results provide a means to value different carer quality of life outcomes in economic evaluation, where such values are needed and deemed appropriate.

Estimating an exchange-rate between care-related and health-related quality of life outcomes for economic evaluation: An application of the wellbeing valuation method.

Quality of life outcomes for family carers and patients may be measured in different ways within the same economic evaluation. We used the wellbeing valuation method to calculate "exchange rates" between care-related outcomes (the Carer Experience Scale and CarerQoL-7D) and health-related (the EQ-5D-5L) outcomes. Data on quality of life outcomes were collected through a postal quality of life survey in the UK. A random effects model was used to estimate carers' wellbeing as a function of their EQ-5D-5L, Carer Experience Scale (or CarerQoL-7D) and a set of control variables. When life satisfaction was used as the measure of wellbeing, a one-point gain in the Carer Experience Scale (0-100 scale) was equivalent (in wellbeing terms) to a 0.014 gain in EQ-5D-5L value; and a one point gain in the CarerQoL-7D (0-100 scale) was equivalent to a 0.033 gain in EQ-5D-5L. The exchange rate values were reduced when capability was used as the measure of wellbeing. The exchange rates estimated in this study offer a means to place carer and patient outcomes, measured via different quality of life instruments, on a common scale, although there are important issues to consider in operationalising the technique.

The scope of carer effects and their inclusion in decision-making: a UK-based Delphi study.

BACKGROUND AND OBJECTIVE: Health and social care may affect unpaid (family) carers' health and wellbeing in addition to patients' lives. It is recommended that such impacts (carer effects) are considered in decision-making. However, the scope of carer effects and range of decisions where carer effects should be considered is uncertain. This study aimed to identify: (i) how different categories of healthcare and social care were perceived to impact on unpaid carers; and (ii) whether there was consensus about when carer effects should be formally considered in decision-making contexts. METHODS: A two round, online Delphi study was conducted with 65 UK-based participants (unpaid carers, care professionals, and researchers) with expertise in dementia, mental health, and stroke. Participants considered two broad forms of 'interventions' (patient treatment and replacement care) and two broad forms of 'organisational change' (staffing and changes in timing/location of care). Participants assessed the likely impacts of these on unpaid carers and whether impacts should be considered in decision-making. RESULTS: Participants predicted interventions and organisational changes would impact on multiple domains of unpaid carers' lives, with 'emotional health' the most likely outcome to be affected. Patient treatment and replacement care services ('interventions') were associated with positive impacts across all domains. Conversely, timing/location changes and staffing changes ('organisational changes') were perceived to have mixed and negative impacts. There was widespread support (80-81 %) for considering carer effects in research studies, funding decisions, and patient decision-making. CONCLUSIONS: This study highlights a perception that carer effects are widespread and important to consider in economic evaluation and decision-making. It highlights the particular need to measure and value effects on carers' emotional health and the need to use a societal perspective to avoid cost shifting to unpaid carers when introducing interventions and making organisational changes.

Exploring young people's preferences for STI screening in the UK: A qualitative study and discrete choice experiment.

INTRODUCTION: Stigma remains a key issue for many health screening interventions such as screening for sexually transmitted infections (STIs). Young people continue to experience the greatest burden of STI infection. In order to increase uptake, screening services need to be more patient-focused. This study sought to examine young people's preferences for sexual health screening to understand how scarce public health resources can optimise screening uptake. METHODS: This study involved both qualitative and quantitative components. Focus groups and individual interviews were undertaken with young people aged 16-24 recruited from community settings and a specialist clinic. Themes which emerged from the focus groups were used to inform the design of a discrete choice experiment (DCE). A questionnaire survey (incorporating the DCE) was conducted with members of an internet panel, with over-sampling of black, Asian and minority ethnic groups. RESULTS: Overall, 41 participants took part in eight focus groups and two in individual interviews. Six major themes emerged as important when making decisions about STI screening - stigma and embarrassment; knowledge about STIs and risk; where to get tested; how staff would treat them; what STIs to be tested for; and convenience (waiting times). Overall, 1946 participants took part in the survey. The DCE results revealed that the most important factors for young people are that all STIs are tested for, and that staff attitude is non-judgemental. The results also suggest that there is a preference for screening in specialist clinics and for full appointments over limited ones. Although respondents preferred shorter time periods for appointments and results, other 'process' factors were also important. CONCLUSION: This study demonstrates that by combining qualitative and quantitative methods, a richer understanding of STI screening preferences is possible. The findings show that comprehensive testing and a perceived 'non-judgemental' attitude are particularly important to young people, as well as convenience.

Measuring Quality of Life in Carers of People With Dementia: Development and Psychometric Evaluation of Scales measuring the Impact of DEmentia on CARers (SIDECAR).

BACKGROUND AND OBJECTIVES: A 2008 European consensus on research outcome measures in dementia care concluded that measurement of carer quality of life (QoL) was limited. Three systematic reviews (2012, 2017, and 2018) of dementia carer outcome measures found existing instruments wanting. In 2017, recommendations were published for developing reliable measurement tools of carers' needs for research and clinical application. The aim of this study was to develop a new instrument to measure the QoL of dementia carers (family/friends). METHODS: Items were generated directly from carers following an inductive needs-led approach. Carers (n = 566) from 22 English and Welsh locations then completed the items and comparator measures at three time points. Rasch, factor, and psychometric (reliability, validity, responsiveness, and minimally important differences [MIDs]) analyses were undertaken. RESULTS: Following factor analysis, the pool of 70 items was refined to three independent scales: primary SIDECAR-D (direct impact of caring upon carer QOL, 18 items), secondary SIDECAR-I (indirect impact, 10 items), and SIDECAR-S (support and information, 11 items). All three scales satisfy Rasch model assumptions. SIDECAR-D, I, S psychometrics: reliability (internal ≥ .70; test-retest ≥ .85); convergent validity (as hypothesized); responsiveness (effect sizes: D: moderate; I and S: small); MIDs (D = 9/100, I = 10/100, S = 11/100). DISCUSSION AND IMPLICATIONS: SIDECAR scales demonstrate robust measurement properties, meeting COSMIN quality standards for study design and psychometrics. SIDECAR provides a theoretically based needs-led QoL profile specifically for dementia carers. SIDECAR is free for use in public health, social care, and voluntary sector services, and not-for-profit organizations.

Patient and Public Involvement (PPI) in Health Economics Methodology Research: Reflections and Recommendations.

Patient and public involvement (PPI) can be used in methods research, as well as applied research, in health economics. However, methods research goals may seem quite abstract when compared to the lived experiences of lay participants. This article draws on 4 years of PPI in a research project to develop methods for including family carer outcomes in economic evaluation. Key challenges in using PPI for health economics methods research relate to (1) training and preparation, (2) maintaining involvement, and (3) selecting suitable tasks. We suggest three criteria for selecting a research task for PPI input based on task importance, professional researcher skills gap, and potential PPI contribution.

UK General Population Utility Values for the SIDECAR-D Instrument Measuring the Impact of Caring for People With Dementia.

OBJECTIVES: Dementia affects many people, with numbers expected to grow as populations age. Many people with dementia receive informal/family/unpaid care, for example, from a spouse or child, which may affect carer quality of life. Measuring the effectiveness of health/social care interventions for carers requires a value measure of the quality-of-life impact of caring. This motivated development of the Scales Measuring the Impact of Dementia on Carers-D (SIDECAR-D) instrument. This study aimed to obtain general population values for SIDECAR-D to aid incorporating the impact of caring in economic evaluation. METHODS: Members of the UK general public completed a best-worst scaling object case survey, which included the 18 SIDECAR-D items and EQ-5D-3L descriptions. Responses were analyzed using scale-adjusted finite mixture models. Relative importance scores (RISs) for the 18 SIDECAR-D items formed the SIDECAR-D relative scale measuring the relative impact of caring. The SIDECAR-D tariff, on the full health = 1, dead = 0 scale, was derived by rescaling EQ-5D-3L and SIDECAR-D RISs so the EQ-5D-3L RISs equaled anchored valuations of the EQ-5D-3L pits state from a visual analog scale task. RESULTS: Five hundred ten respondents completed the survey. The model had 2 parameter and 3 scale classes. Additive utility decrements of SIDECAR-D items ranged from -0.05 to -0.162. Utility scores range from 0.95 for someone affirming 1 item to -0.297 for someone affirming all 18. CONCLUSION: SIDECAR-D is a needs-based scale of the impact on quality of life of caring for someone with dementia, with a valuation tariff to support its use in economic evaluation.