Valuation survey for SF-6Dv2 in Japan based on the international protocol.

Purpose: The SF-6D Classification System was recently updated (SF-6Dv2). We performed a valuation survey to construct a value set for the SF-6Dv2 in Japan.

Methods: An online discrete choice experiment (DCE) with duration was used to estimate a value set for the SF-6Dv2 for Japan based on public preferences.

The Short Form 6 Dimensions (SF-6D): Development and Evolution.

This paper considers the development and evolution of the short-form 6 dimensions (SF-6D), a generic preference-weighted measure consisting of a health classification with accompanying value set that was developed from one of the widest used health related quality of life measures, the SF-36 health survey. This enabled health state utility values to be directly generated from SF-36 and SF-12 data for a range of purposes, including to produce quality adjusted life years for use in economic evaluation of healthcare interventions across a range of different conditions and treatments. This paper considers the rationale for the development of the measure, the development process, performance and how the SF-6D has evolved since its conception.

Effect of present state bias on minimal important change estimates: a simulation study.

Purpose: The minimal important change (MIC) in a patient-reported outcome measure is often estimated using patient-reported transition ratings as anchor. However, transition ratings are often more heavily weighted by the follow-up state than by the baseline state, a phenomenon known as "present state bias" (PSB). It is unknown if and how PSB affects the estimation of MICs using various methods.

Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials.

Aims: To summarize the effects of semaglutide 2.4 mg on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning.

Materials And Methods: The STEP 1-4 Phase 3a, 68-week, double-blind, randomized controlled trials assessed the efficacy and safety of semaglutide 2.

Meaningful score changes for SF-36v2, FACIT-fatigue, and RASIQ in rheumatoid arthritis.

Background: Interpretation thresholds for patient-reported outcome (PRO) scores are of crucial importance, particularly when interpreting treatment benefit. This study was designed to determine the within-patient meaningful improvement (WPMI) thresholds for the Short-Form 36 Health Survey version 2 (SF-36v2), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), and the novel Rheumatoid Arthritis Symptoms and Impact Questionnaire (RASIQ) among patients with rheumatoid arthritis (RA).

Methods: In this post-hoc analysis, anchor-based and supportive distribution-based methods were used to derive WPMI based on blinded data from all treatment arms in two Phase 2 RA trials with otilimab.

Patient-Reported Outcomes Measures, Polycystic Kidney Disease Burden, and Outcomes in Autosomal Dominant Polycystic Kidney Disease.

Rationale & Objective: Using OVERTURE (NCT01430494) study data on patient-perceived health, health care utilization, and productivity in autosomal dominant polycystic kidney disease (ADPKD), this research was conducted to characterize the burden of illness in patients with ADPKD and assess whether patient-reported outcome (PRO) assessment scores predict clinical and health-economic outcomes.

Study Design: Data were analyzed from a prospective, observational study.

Setting & Participants: The study cohort comprised 3,409 individuals with ADPKD in 20 countries who were aged 12-78 years and were in chronic kidney disease (CKD) stages G1-G5 and Mayo risk subclasses 1A-1E.

Estimating anchor-based minimal important change using longitudinal confirmatory factor analysis.

Purpose: The minimal important change (MIC) is defined as the smallest within-individual change in a patient-reported outcome measure (PROM) that patients on average perceive as important. We describe a method to estimate this value based on longitudinal confirmatory factor analysis (LCFA). The method is evaluated and compared with a recently published method based on longitudinal item response theory (LIRT) in simulated and real data.

Severity of hypothyroidism is inversely associated with impaired quality of life in patients referred to an endocrine clinic.

Purpose: We investigated the association between health-related quality of life (HRQL) and the severity of hypothyroidism at diagnosis in patients referred to a secondary hospital clinic.

Methods: Sixty-seven adult patients referred from primary care were enrolled. All patients had newly diagnosed hypothyroidism due to autoimmune thyroiditis and were treated with levothyroxine (LT4).

The improved health utility of once-weekly subcutaneous semaglutide 2.4 mg compared with placebo in the STEP 1-4 obesity trials.

Aim: To assess health utility values in the Semaglutide Treatment Effect in People with obesity (STEP) 1-4 trials.

Materials And Methods: The STEP 1-4 phase 3a, 68-week, double-blind randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with a body mass index (BMI) of 30 kg/m or higher or a BMI of 27 kg/m or higher and at least one comorbidity (STEP 1, 3 and 4), or a BMI of 27 kg/m or higher and type 2 diabetes (STEP 2).

Estimating meaningful thresholds for multi-item questionnaires using item response theory.

Purpose: Meaningful thresholds are needed to interpret patient-reported outcome measure (PROM) results. This paper introduces a new method, based on item response theory (IRT), to estimate such thresholds. The performance of the method is examined in simulated datasets and two real datasets, and compared with other methods.

Quality of life in thyroid cancer.

To explore the impact of differentiated thyroid cancer (DTC) on quality of life (QoL) a clinical analytical framework was developed. Based on the clinical analytical framework, a systematic literature search was performed to identify studies applying patient-reported outcomes (PRO) instruments among patients with DTC. Subsequently, the scope was narrowed down to studies comparing scores on the Medical Outcomes Study (MOS) Short form 36 (SF-36) to a reference population (clinical interpretability criterion).

Health and quality of life of patients with haemophilia: A national study of 124 Danish men.

Purpose: In the past decades, haemophilia treatment has greatly improved the health of persons with haemophilia (PWH). This study compares PWH to the general population on social conditions and health.

Methods: In December 2021, all Danes with moderate or severe haemophilia A or B, or von Willebrands disease type 3 were invited to participate in an online self-report survey concerning sociodemographic factors, self-rated health, teeth status, chronic health conditions, symptoms and loneliness.

Implementation of thyroid-related patient-reported outcomes in routine clinical practice.

Patient-reported outcomes (PROs) are increasingly used in clinical practice to improve clinical care. Multiple studies show that systematic use of PROs can enhance communication with patients and improve patient satisfaction, symptom management and quality of life. Further, such data can be aggregated to examine health levels for patient groups, improve quality of care, and compare patient outcomes at the institutional, regional or national level.

The Predictive Validity of the Danish Psychosocial Work Environment Questionnaire With Regard to Onset of Depressive Disorders and Long-Term Sickness Absence.

Objectives: To investigate the predictive validity of 32 measures of the Danish Psychosocial Work Environment Questionnaire (DPQ) against two criteria variables: onset of depressive disorders and long-term sickness absence (LTSA).

Methods: The DPQ was sent to 8958 employed individuals in 14 job groups of which 4340 responded (response rate: 48.4%).

Deciding Between SF-6Dv2 Health States: A Think-Aloud Study of Decision-Making Strategies Used in Discrete Choice Experiments.

Objective: This study aimed to gain insight into decision-making strategies individuals used when evaluating pairs of SF-6Dv2 health states in discrete choice experiments (DCEs).

Methods: This qualitative, cross-sectional, noninterventional study asked participants to use a think-aloud approach to compare SF-6Dv2 health states in DCEs. Thematic analysis focused on comprehension and cognitive strategies used to compare health states and make decisions.

Establishing thresholds for meaningful within-individual change using longitudinal item response theory.

Purpose: Thresholds for meaningful within-individual change (MWIC) are useful for interpreting patient-reported outcome measures (PROM). Transition ratings (TR) have been recommended as anchors to establish MWIC. Traditional statistical methods for analyzing MWIC such as mean change analysis, receiver operating characteristic (ROC) analysis, and predictive modeling ignore problems of floor/ceiling effects and measurement error in the PROM scores and the TR item.

Physical work demands and expected labor market affiliation (ELMA): Prospective cohort with register-follow-up among 46 169 employees.

Objective: This study aimed to estimate the impact of high physical work demands on expected labor market affiliation (ELMA) among men and women of different ages in the general working population.

Methods: After participating in the Danish Work Environment and Health study (2012, 2014, and/or 2016), 46 169 employees were followed for two years in national registers. Using multi-state modeling, taking all day-to-day transition probabilities of labor market affiliation into account (work, unemployment, sickness absence, temporary out, and permanently out), and performing multilevel adjustment, we estimated the prospective association between physical work demands (ergonomic index including 7 factors) and ELMA.

Development of the SF-6Dv2 health utility survey: comprehensibility and patient preference.

Background: The SF-6Dv2 classification system assesses health states in six domains-physical functioning, role function, bodily pain, vitality, social functioning, and mental health. Scores have previously been derived from the SF-36v2® Health Survey. We aimed to develop a six-item stand-alone SF-6Dv2 Health Utility Survey (SF-6Dv2 HUS) and evaluate its comprehensibility.

Developing a New Generic Health and Wellbeing Measure: Psychometric Survey Results for the EQ-HWB.

Objectives: The development of measures such as the EQ-HWB (EQ Health and Wellbeing) requires selection of items. This study explored the psychometric performance of candidate items, testing their validity in patients, social carer users, and carers.

Methods: Article and online surveys that included candidate items (N = 64) were conducted in Argentina, Australia, China, Germany, United Kingdom, and the United States.

Present state bias in transition ratings was accurately estimated in simulated and real data.

Objective: Patient-reported transition ratings are supposed to reflect the change between a previous baseline health state and a present follow-up state, but may reflect the present state to a greater extent. This so-called "present state bias" (PSB) potentially threatens the validity of transition ratings. Several criteria have been proposed to assess PSB.