Adaptive design trials in eating disorder research: A scoping review.

OBJECTIVE: This scoping review sought to map the breadth of literature on the use of adaptive design trials in eating disorder research. METHOD: A systematic literature search was conducted in Medline, Scopus, PsycInfo, Emcare, Econlit, CINAHL and ProQuest Dissertations and Theses. Articles were included if they reported on an intervention targeting any type of eating disorder (including anorexia nervosa, bulimia nervosa, binge-eating disorder, and other specified feeding or eating disorders), and employed the use of an adaptive design trial to evaluate the intervention. Two independent reviewers screened citations for inclusion, and data abstraction was performed by one reviewer and verified by a second. RESULTS: We identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge-eating disorder conducted in the USA and Australia. All employed adaptive treatment arm switching based on early response to treatment and identified a priori stopping rules. None of the studies included value of information analysis to guide adaptive design decisions and none included lived experience perspectives. DISCUSSION: The limited use of adaptive designs in eating disorder trials represents a missed opportunity to improve enrolment targets, attrition rates, treatment outcomes and trial efficiency. We outline the range of adaptive methodologies, how they could be applied to eating disorder research, and the specific operational and statistical considerations relevant to adaptive design trials. PUBLIC SIGNIFICANCE: Adaptive design trials are increasingly employed as flexible, efficient alternatives to fixed trial designs, but they are not often used in eating disorder research. This first scoping review identified five adaptive design trials targeting anorexia nervosa, bulimia nervosa and binge-eating disorder that employed treatment arm switching adaptive methodology. We make recommendations on the use of adaptive design trials for future eating disorder trials.

OBJETIVO: Esta revisión exploratoria buscó mapear el alcance de la literatura sobre el uso de ensayos de diseño adaptativo en la investigación de trastornos de conducta alimentaria. MÉTODO: Se realizó una búsqueda sistemática de literatura en Medline, Scopus, PsycInfo, Econlit y CINAHL. Se incluyeron artículos que informaban sobre una intervención dirigida a cualquier tipo de trastorno de conducta alimentaria (incluyendo anorexia nerviosa, bulimia nerviosa, trastorno por atracón y otros trastornos de la conducta alimentaria o de la ingestión de alimentos especificados) y empleaban el uso de un ensayo de diseño adaptativo para evaluar la intervención. Dos revisores independientes examinaron las citas para su inclusión, y la abstracción de datos fue realizada por un revisor y verificada por otro. RESULTADOS: Identificamos cinco ensayos de diseño adaptativo dirigidos a la anorexia nerviosa, bulimia nerviosa y trastorno por atracón realizados en Estados Unidos y Australia. Todos emplearon el cambio adaptativo de brazo de tratamiento basado en la respuesta temprana al tratamiento e identificaron reglas de detención a priori. Ninguno de los estudios incluyó análisis del Valor de la Información para guiar las decisiones de diseño adaptativo y ninguno incluyó perspectivas de experiencia vivida. DISCUSIÓN: El uso limitado de diseños adaptativos en ensayos de trastornos de conducta alimentaria representa una oportunidad perdida para mejorar los objetivos de reclutamiento, tasas de deserción, resultados del tratamiento y eficiencia del ensayo. Esbozamos la gama de metodologías adaptativas, cómo podrían aplicarse a la investigación de trastornos de conducta alimentaria, y las consideraciones operativas y estadísticas específicas relevantes para los ensayos de diseño adaptativo. PÚBLICA SIGNIFICANCIA: Los ensayos de diseño adaptativo se emplean cada vez más como alternativas flexibles y eficientes a los diseños de ensayos fijos, pero no se utilizan con frecuencia en la investigación de trastornos de conducta alimentaria. Esta primera revisión exploratoria identificó cinco ensayos de diseño adaptativo dirigidos a la anorexia nerviosa, bulimia nerviosa y trastorno por atracón que emplearon la metodología adaptativa de cambio de brazo de tratamiento. Hacemos recomendaciones sobre el uso de ensayos de diseño adaptativo para futuros ensayos de trastornos de conducta alimentaria.

Lived experience perspectives on eating disorder research: The use of adaptive trials and research priorities.

OBJECTIVE: This novel study sought to understand lived experience and carer perspectives on the use of adaptive trials to evaluate interventions for eating disorders, in addition to understanding the factors and outcomes of most importance in eating disorder research and treatments from a lived experience perspective. METHOD: A total of 73 people with either lived or carer experience consented, 70 started the questionnaire, and 36 (51%) completed all questions. Participants were asked Likert scale and open-ended questions to understand what factors and outcomes of eating disorder interventions were most important to them and understand their pre-existing knowledge of clinical trials. Two videos were then used to explain randomized controlled trials (RCTs) and adaptive trials and participants were asked their opinions, including perceived benefits and concerns, of each trial type. RESULTS: The thematic analysis found two key themes regarding factors important in eating disorder treatment: Person-centred care and Evidence-based and effective treatment; and two key themes regarding outcomes of treatment: Sustained, full recovery and The bigger picture. Both RCTs and adaptive trials were viewed favorably, however, there was a slight preference for adaptive trials. Key themes for both demonstrated perceived benefits and ethical, practical, and scientific considerations unique to each. DISCUSSION: Findings demonstrate the support of adaptive trials in eating disorder interventions from people with lived experience and their carers. It is recommended that researchers consider the use of adaptive designs and the incorporation of lived experience perspectives when designing future intervention trials. PUBLIC SIGNIFICANCE: This novel study found that the use of adaptive trials in eating disorder intervention research is supported by people with lived experience and carers. Furthermore, the factors and outcomes of most importance to participants in this study are comparable to those previously identified in the emerging literature. The use of adaptive designs and the incorporation of lived experience are recommended in further clinical trials.

An exploration of healthcare use in older people waiting for and receiving Australian community-based aged care services.

AIM: Home care packages (HCPs) facilitate older individuals to remain at home, with longer HCP wait times associated with increased mortality risk. We analyze healthcare cost data pre- and post-HCP access to inform hypotheses around the effects of healthcare use and mortality risk. METHODS: Regression models were used to assess the impact of delayed HCP access on healthcare costs and to compare costs whilst waiting and in the 6- and 12 month periods post-HCP access for 16 629 older adults. RESULTS: Average wait time for a HCP was 89.7 days (SD = 125.6) during the study period. Wait-time length had no impact on any healthcare cost category or time period. However, total per day healthcare costs were higher in the 6 and 12 months post-receipt of a HCP (AU$61.5, AU$63, respectively) compared with those in the time waiting for a HCP (AU$48.1). Inpatient care accounted for a higher proportion of total healthcare costs post-HCP (AU$45.1, AU$46.3, respectively) compared with in the wait time (AU$30.6), whilst spending on medical services and pharmaceuticals reduced slightly in the 6 month (AU$7.1, AU$6.3) and 12 month (AU$7.2, AU$6.3) post-HCP periods compared with in the wait time (AU$7.9, AU$7.1). CONCLUSIONS: Increased spending post-HCP on inpatient care or non-health support afforded by HCPs may offer protective effects for mortality and risk of admission to aged care. Further research should explore the association between delayed access to inpatient care for geriatric syndromes and mortality to inform recommendations on extensions to residential care outreach services into the community to improve the timely identification of the need for inpatient care. Geriatr Gerontol Int 2023; 23: 899-905.

DAta Linkage to Enhance Cancer Care (DaLECC): Protocol of a Large Australian Data Linkage Study.

Cancer is a leading cause of global morbidity and mortality, accounting for 250 Disability-Adjusted Life Years and 10 million deaths in 2019. Minimising unwarranted variation and ensuring appropriate cost-effective treatment across primary and tertiary care to improve health outcomes is a key health priority. There are few studies that have used linked data to explore healthcare utilisation prior to diagnosis in addition to post-diagnosis patterns of care. This protocol outlines the aims of the DaLECC project and key methodological features of the linked dataset. The primary aim of this project is to explore predictors of variations in pre- and post-cancer diagnosis care, and to explore the economic and health impact of any variation. The cohort of patients includes all South Australian residents diagnosed with cancer between 2011 and 2020, who were recorded on the South Australian Cancer Registry. These cancer registry records are being linked with state and national healthcare databases to capture health service utilisation and costs for a minimum of one-year prior to diagnosis and to a maximum of 10 years post-diagnosis. Healthcare utilisation includes state databases for inpatient separations and emergency department presentations and national databases for Medicare services and pharmaceuticals. Our results will identify barriers to timely receipt of care, estimate the impact of variations in the use of health care, and provide evidence to support interventions to improve health outcomes to inform national and local decisions to enhance the access and uptake of health care services.

Empirical Estimates of the Marginal Cost of Health Produced by a Healthcare System: Methodological Considerations from Country-Level Estimates.

Many health technology assessment committees have an explicit or implicit reference value (often referred to as a 'threshold') below which new health technologies or interventions are considered value for money. The basis for these reference values is unclear but one argument is that it should be based on the health opportunity costs of funding decisions. Empirical estimates of the marginal cost per unit of health produced by a healthcare system have been proposed to capture the health opportunity costs of new funding decisions. Based on a systematic search, we identified eight studies that have sought to estimate a reference value through empirical estimation of the marginal cost per unit of health produced by a healthcare system for England, Spain, Australia, The Netherlands, Sweden, South Africa and China. We review these eight studies to provide an overview of the key methodological approaches taken to estimate the marginal cost per unit of health produced by the healthcare system with the aim to help inform future estimates for additional countries. The lead author for each of these papers was invited to contribute to the current paper to ensure all the key methodological issues encountered were appropriately captured. These included consideration of the key variables required and their measurement, accounting for endogeneity of spending to health outcomes, the inclusion of lagged spending, discounting and future costs, the use of analytical weights, level of disease aggregation, expected duration of health gains, and modelling approaches to estimating mortality and morbidity effects of health spending. Subsequent research estimates for additional countries should (1) carefully consider the specific context and data available, (2) clearly and transparently report the assumptions made and include stakeholder perspectives on their appropriateness and acceptability, and (3) assess the sensitivity of the preferred central estimate to these assumptions.

Subjective well-being in older adults: folate and vitamin B12 independently predict positive affect.

Vitamin B12, folate and homocysteine have long been implicated in mental illness, and growing evidence suggests that they may play a role in positive mental health. Elucidation of these relationships is confounded due to the dependence of homocysteine on available levels of vitamin B12 and folate. Cross-sectional and longitudinal relationships between vitamin B12, folate, homocysteine and subjective well-being were assessed in a sample of 391 older, community-living adults without clinically diagnosed depression. Levels of vitamin B12, but not folate, influenced homocysteine levels 18 months later. Vitamin B12, folate and their interaction significantly predicted levels of positive affect (PA) 18 months later, but had no impact on the levels of negative affect or life satisfaction. Cross-sectional relationships between homocysteine and PA were completely attenuated in the longitudinal analyses, suggesting that the cross-sectional relationship is driven by the dependence of homocysteine on vitamin B12 and folate. This is the first study to offer some evidence of a causal link between levels of folate and vitamin B12 on PA in a large, non-clinical population.