Effectiveness and cost-effectiveness of guided self-help for depression for autistic adults: the Autism Depression Trial (ADEPT-2) - protocol for a multicentre, randomised controlled trial of a remotely delivered low-intensity intervention.

Introduction: Depression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression specifically adapted to meet the needs of autistic adults. ADEPT-2 aims to establish the clinical and cost-effectiveness of an adapted low-intensity psychological intervention (guided self-help) for depression in autistic adults.

Hospital-based Costs to the National Health Service (UK) for Children and Adolescents Born with Cleft from Birth to 20 Years.

Objective: The primary aim was to assess the cost (£) to the National Health Service (NHS) of hospital treatment for individuals born with bilateral cleft lip and palate (BCLP), unilateral cleft lip and palate (UCLP), and cleft palate (CP), from birth to 20 years. The secondary aim was to assess the number of scheduled clinical outpatient and inpatient/outpatient surgical visits for this cohort.

Design: Retrospective micro-costing analysis.

The Development of a New Approach for the Harmonized Multi-Sectoral and Multi-Country Cost Valuation of Services: The PECUNIA Reference Unit Cost (RUC) Templates.

Background: Increasing healthcare costs require evidence-based resource use allocation for which assessing costs rigorously and comparably is crucial. Harmonized cross-country costing methods for evaluating interventions from a societal perspective are lacking. This study presents the development process and content of the service costing templates developed as part of the European project PECUNIA.

A pragmatic cluster randomised controlled trial of air filtration to prevent symptomatic winter respiratory infections (including COVID-19) in care homes (AFRI-c) in England: Trial protocol.

Background: Respiratory tract infections are readily transmitted in care homes. Airborne transmission of pathogens causing respiratory tract illness is largely unmitigated. Portable high-efficiency-particulate-air (HEPA) filtration units capture microbial particles from the air, but it is unclear whether this is sufficient to reduce infections in care home residents.

Identification and prioritisation of items for a draft participant-reported questionnaire to measure use of social care, informal care, aids and adaptations.

Background: Resource-use measurement is integral for assessing cost-effectiveness within trial-based economic evaluations. Methods for gathering resource-use data from participants are not well developed, with questionnaires typically produced for each trial and rarely validated. The healthcare module of a generic, modular resource-use measure, designed for collecting self-report resource-utilisation data, has recently been developed in the UK.

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.

Background: Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, issues to be considered before the decision to use HSD for outcome data in a clinical trial is finalised, a methodological question prioritised by the clinical trials community.

Methods: The PRIMORANT study had three phases.

Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.

Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects.

Development of a brief, generic, modular resource-use measure (ModRUM): piloting with patients.

Background: Bespoke self-report resource-use measures (RUMs) are commonly developed or adapted for each new randomised controlled trial. Consequently, RUMs lack standardisation and validation is rarely conducted. A new generic RUM, ModRUM, has been developed using a rigorous process, including consultation with health economists and patients.

Impact of PSA testing on secondary care costs in England and Wales: estimates from the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

Background: Screening men for prostate cancer using prostate-specific antigen (PSA) testing remains controversial. We aimed to estimate the likely budgetary impact on secondary care in England and Wales to inform screening decision makers.

Methods: The Cluster randomised triAl of PSA testing for Prostate cancer study (CAP) compared a single invitation to men aged 50-69 for a PSA test with usual care (no screening).

Development of an Instrument for the Assessment of Health-Related Multi-sectoral Resource Use in Europe: The PECUNIA RUM.

Background: Measuring objective resource-use quantities is important for generating valid cost estimates in economic evaluations. In the absence of acknowledged guidelines, measurement methods are often chosen based on practicality rather than methodological evidence. Furthermore, few resource-use measurement (RUM) instruments focus on the measurement of resource use in multiple societal sectors and their development process is rarely described.

Commentary/Response: Economic evidence should be routinely collected and reported for studies of intervention effectiveness in mental health. A commentary on Vartiainen et al. (2022).

Anxiety and related disorders are increasingly widespread amongst children and adolescents. Preventing mental health disorders from developing has the potential to realise long-term benefits for children and adolescents. In their paper, 'Economic evidence of preventive interventions for anxiety disorders in children and adolescents-a systematic review', Vartiainen et al.

Brief intervention to reduce fatigue impact in patients with inflammatory arthritis: design and outcomes of a single-arm feasibility study.

Objectives: Patients with inflammatory arthritis report that fatigue is challenging to manage. We developed a manualised, one-to-one, cognitive-behavioural intervention, delivered by rheumatology health professionals (RHPs). The Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis (FREE-IA) study tested the feasibility of RHP training, intervention delivery and outcome collection ahead of a potential trial of clinical and cost-effectiveness.

Cost-Effectiveness of Group-Based Outpatient Physical Therapy After Total Knee Replacement: Results From the Economic Evaluation Alongside the ARENA Multicenter Randomized Controlled Trial.

Objective: To assess the cost-utility and cost-effectiveness of a group-based outpatient physical therapy intervention delivered 6 weeks after primary total knee replacement (TKR) compared with usual care, alongside the Activity-Orientated Rehabilitation Following Knee Arthroplasty (ARENA) multicenter, randomized, controlled trial.

Methods: The economic analyses were performed from the perspective of the health and social care payer. We collected resource use for health and social care and productivity losses and patient outcomes for 12 months after surgery to derive costs and quality-adjusted life years (QALYs).

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

Introduction: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging.

Aspects and Challenges of Resource Use Measurement in Health Economics: Towards a Comprehensive Measurement Framework.

Background: While the methods for conducting health economics research in general are improving, current guidelines provide limited guidance regarding resource use measurement (RUM). Consequently, a variety of methods exists, yet there is no overview of aspects to consider when deciding on the most appropriate RUM methodology. Therefore, this study aims to (1) identify and categorize existing knowledge regarding aspects of RUM, and (2) develop a framework that provides a comprehensive overview of methodological aspects regarding RUM.

Development of a brief, generic, modular resource-use measure (ModRUM): cognitive interviews with patients.

Background: Self-report resource-use measures (RUMs) are often used to collect healthcare use data from participants in healthcare studies. However, RUMs are typically adapted from existing measures on a study-by-study basis, resulting in a lack of standardisation which limits comparability across studies. Psychometric testing of RUMs is rarely conducted.

Content of Health Economics Analysis Plans (HEAPs) for Trial-Based Economic Evaluations: Expert Delphi Consensus Survey.

Objectives: Health economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials.

Methods: A list of potential items for inclusion was developed by examining existing HEAPs.

The ProtecT randomised trial cost-effectiveness analysis comparing active monitoring, surgery, or radiotherapy for prostate cancer.

Background: There is limited evidence relating to the cost-effectiveness of treatments for localised prostate cancer.

Methods: The cost-effectiveness of active monitoring, surgery, and radiotherapy was evaluated within the Prostate Testing for Cancer and Treatment (ProtecT) randomised controlled trial from a UK NHS perspective at 10 years' median follow-up. Prostate cancer resource-use collected from hospital records and trial participants was valued using UK reference-costs.

Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial.

Objective: Patients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.

Design: Economic evaluation conducted alongside a pragmatic cluster-randomised trial.

Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.

Background: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists.

Objectives: To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.

Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT).

Objectives: To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.

Methods: Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses.

Self-reported and routinely collected electronic healthcare resource-use data for trial-based economic evaluations: the current state of play in England and considerations for the future.

Background: Randomised controlled trials (RCTs) are generally regarded as the "gold standard" for providing quantifiable evidence around the effectiveness and cost-effectiveness of new healthcare technologies. In order to perform the economic evaluations associated with RCTs, there is a need for accessible and good quality resource-use data; for the purpose of discussion here, data that best reflect the care received. Traditionally, researchers have developed questionnaires for resource-use data collection.