We aim to compare the measurement properties of three indirect (EQ-5D-5L, PROPr, SF-6D) and one direct (time trade-off, TTO) utility assessment methods in patients with chronic skin diseases.

120 patients with physician-diagnosed chronic skin diseases (psoriasis 39%, atopic dermatitis 27%, acne 19%) completed a cross-sectional survey. Respondents completed the EQ-5D-5L, PROMIS-29+2 and SF-36v1 questionnaires and a 10-year TTO task for own current health. Utilities were computed using the US value sets. Ceiling, convergent and known-group validity were compared across the utilities derived with these four methods. Known-groups were defined based on general, physical and mental health. The agreement between utilities was assessed using intraclass correlation coefficients (ICC).

Mean utilities for the EQ-5D-5L, PROPr, SF-6D and TTO were 0.79, 0.47, 0.76 and 0.89. In corresponding order, the ceiling was 28%, 0%, 2% and 65%. The SF-6D showed excellent agreement with the EQ-5D-5L (ICC = 0.770). PROPr demonstrated poor agreement with the EQ-5D-5L (ICC = 0.381) and fair with SF-6D utilities (ICC = 0.445). TTO utilities showed poor agreement with indirectly assessed utilities (ICC = 0.058-0.242). The EQ-5D-5L better discriminated between known groups of general and physical health, while the SF-6D and PROPr outperformed the EQ-5D-5L for mental health problems.

There is a great variability in utilities across the four methods in patients with chronic skin conditions. The EQ-5D-5L, despite its higher ceiling, appears to be the most efficient in discriminating between patient groups for physical health aspects. Our findings inform the choice of instrument for quality-adjusted life year calculations in cost-utility analyses.

The EQ-5D-5L five-dimensional instrument, is one of the most widely used generic preference-based questionnaires to measure health-related quality of life and to estimate utility indices for use in economic evaluation. This study aimed to assess the psychometric properties of the Spanish EQ-5D-5L questionnaire in patients with Diabetes Mellitus (DM) assessing reliability, validity, and item-level properties such as item functioning.

We included 133 patients with DM who completed the EQ-5D-5L, the Audit on Diabetes-Dependent Quality of Life (ADDQoL), the Hospital Anxiety and Depression Scale (HADS), one question about general health and sociodemographic, and clinical data. The reliability was assessed by Cronbach's alpha, and the item functioning by the item response theory (IRT). Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L, ADDQoL, HADS and the general health question. We examined known-groups validity by comparing the EQ-5D-5L scores between subgroups defined by age, gender, BMI, regular physical activity, disease duration, glycemic control by glycosylated blood hemoglobin (HbA1c) (%), type of DM, general health and anxiety and depression level using t-test, ANOVA, Wilcoxon or Kruskal-Wallis tests.

The reliability was supported with a Cronbach's alpha of 0.78. The IRT results supported the unidimensionality and showed adequate item functioning, except for the anxiety/depression dimension. The item with highest discriminatory power was usual activities dimension, followed by self-care and mobility dimensions. The EQ-5D-5L showed adequate convergent validity, with high correlation with the ADDQoL, HADS and general health. Older age, women, obese, no regular physical activity, ≥ 10 years of disease duration, poor glycemic control, poorer general health and higher anxiety and depression level linked with lower EQ-5D-5L scores.

These findings support the adequate psychometric properties of the EQ-5D-5L in patients with DM, supporting its use for clinicians and researchers as an outcome measure and for use in economic evaluation studies.

The primary goal of this study was to measure health-state utility values (HUVs) in patients with facial paralysis before and after treatment. A secondary objective was to compare these values with those of other chronic diseases and currently available treatments.

A retrospective chart review.

A tertiary medical center.

Adults with flaccid and non-flaccid facial paralysis were included. Baseline demographics, medical comorbidities, facial paralysis history, treatment details, and disease-specific quality-of-life scores were collected. Utility values were derived using the Short-Form 6D health index at baseline and after treatment.

The mean baseline Short-Form 6D utility value for patients with facial paralysis (n = 134) was 0.73 (± 0.14) (95% confidence interval [CI]: 0.71-0.75). Baseline utility values significantly correlated with disease-specific quality of life as measured by the Facial Clinimetric Evaluation Scale (r = 0.400; P < .001), but not with Sunnybrook Facial Grading Scale or Synkinesis Assessment Questionnaire scores. Post-treatment utility values showed a mean improvement of 0.03 (95% CI: -0.01 to 0.08; P = .14) in the overall cohort. The flaccid group showed a greater average improvement compared to the non-flaccid group (0.05 [± 0.17] vs 0.02 [± 0.17]; P = .62).

Patients with flaccid and non-flaccid facial paralysis reported HUVs that were significantly lower than the US population norm. Treatment improved utility values in both groups. These findings provide initial data for future cost-effectiveness analyses of surgical and non-surgical treatment options for facial paralysis.

'Caregiver health spillovers' refer to the broader impacts of an individual's illness and interventions on informal caregivers' health and well-being. This study focuses on the spillover effects experienced by parental carers of children with coronavirus disease 2019 (COVID-19), aiming to compare the psychometric properties of the EQ-5D-5L and the experimental EQ Health and Wellbeing Short version (EQ-HWB-S) in capturing these effects.

A longitudinal study was conducted with 861 parental carers of children aged 0-18 years with COVID-19 and 231 parents of healthy children as the control group. The EQ-5D-5L and EQ-HWB-S were used to assess parental health and well-being. Analyses included known-groups validity (multivariable regression), test-retest reliability (Gwet's AC1, intraclass correlation coefficient) and responsiveness to health improvement (Glass' Δ effect size).

Parents of infected children reported more problems than those of healthy controls. The EQ-HWB-S better discriminated between sub-groups defined by the child's COVID-19 presence, caring time and work impact. Test-retest reliability was fair to good for EQ-HWB-S dimensions (Gwet's AC1: 0.33-0.79), moderate to good for EQ-5D-5L (Gwet's AC1: 0.40-0.76), and good for index scores and EQ VAS (intraclass correlation coefficient: 0.70-0.77). Parental health and well-being improved as children recovered, with the EQ-5D-5L showing slightly higher responsiveness (effect size: 0.77-0.87) than EQ-HWB-S (effect size: 0.62-0.74).

Both EQ-HWB-S and EQ-5D-5L are valid, reliable and responsive for measuring parental spillover effects related to a child's COVID-19 infection. EQ-HWB-S outperformed in distinguishing social and emotional impacts of caregiving, while EQ-5D-5L better captured physical health improvements. The choice between tools may depend on study objectives.

Patient-reported outcome measures (PROMs) are crucial to capture patients' health and illness status. Selecting the most suitable PROM to measure self-reported health in a specific study population is essential. Shortcomings of much used generic instruments have been identified in certain populations, and more investigation is needed to clarify the extent to which the generic instruments capture the aspects of health that really matter to patients. Therefore, the aim of this study was to determine floor and ceiling effects of a generic health utility instrument (EQ-5D-5L) in an international multi-centre cohort of patients after percutaneous coronary intervention (PCI) and further explore those with perfect health scores by using a disease-specific instrument.

The CONCARDPCI study was conducted at seven large referral PCI centres in Norway and Denmark between June 2017 and May 2020. In all, 2574 unique patients were available for this analysis. The generic EQ-5D-5L descriptive system and visual analogue scale, and the disease-specific Myocardial Infarction Dimensional Assessment Scale (MIDAS) comprising 35 items measuring seven areas of health status and daily life challenges were used to scrutinize the aims. Latent class analyses were conducted to identify classes with similar patterns of daily life challenges based on MIDAS item scores within the group of patients with best possible EQ-5D-5L score ('perfect scorers').

There was a large ceiling effect on the EQ-5D-5L score in patients with coronary artery disease (CAD) with 32% scoring the best possible EQ-5D-5L score, suggesting perfect health. Latent class analysis on the MIDAS revealed, however, four classes where 17-46% of the perfect scorers did perceive challenges in health, particularly related to symptoms of fatigue, and worries about risk factors and side effects of medication.

To obtain an accurate picture of patients' health status, these results emphasize that both generic and disease-specific patient-reported outcomes measures are needed to capture the distinct problems that patients with CAD experience after PCI. Caution should be made when using the EQ-5D-5L as the sole measure, particularly in priority settings, due to its potential ceiling effect and the fact that important aspects of patient health may be neglected.

NCT03810612.

Hearing loss, deafness, and other hearing-related conditions can significantly impact quality of life; numerous qualitative studies have sought to describe these impacts. Synthesis of these findings may provide additional or more robust insights.

A qualitative systematic review of studies reporting qualitative data relating to the impact of hearing problems on adults' health-related quality of life. A subset of studies was included in the review and subsequently analysed using a thematic approach.

The literature search yielded 129 studies, of which 22 met our inclusion criteria and were included for analysis. The included studies, primarily from Australia, the UK, and the USA, involved approximately 450 participants with various hearing conditions. Semi-structured interviews and focus groups were the most common data collection methods, with thematic analysis being the predominant analytical approach. Three overarching categories of descriptive themes were identified: Physical, Mental, and Social. Physical encompassed sound localization, sound clarity, speech, and physical fatigue. Social included relationships, isolation, communication, independence, work function, social stigma, and confidence. Mental encompassed depression, anxiety, listening effort, mental fatigue, fear, and identity. The identified themes shed light on the diverse domains of health-related quality of life affected by hearing conditions.

Differences in hearing function impact upon people's health-related quality of life in a variety of ways relating to physical, mental, and social aspects of health, and these themes are clearly demonstrated across qualitative studies. These results will inform the development of hearing-specific questionnaire items for with the EQ-5D descriptive system, a commonly used patient-reported outcome measure.

Type 2 diabetes and obesity are associated with reduced health-related quality of life (HRQoL) and health utility (HU), but long-term effects of metabolic/bariatric surgery (MBS) compared with those of medical/lifestyle intervention (MLI) on these outcomes are unclear.

We studied 228 individuals with type 2 diabetes and obesity randomly assigned to MBS (Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric band; n = 152) or MLI (n = 76) in the ARMMS-T2D study. HRQoL (36-Item Short-Form Health Survey [SF-36], including Physical Component Score [PCS] and Mental Component Score [MCS]) and HU (Short Form 6 Dimensions [SF-6D]) were measured annually up to 12 years.

At baseline, participants' mean ± SD age was 49.2 ± 8.0 years, 68.4% were female, BMI was 36.3 ± 3.4 kg/m2, and HbA1c was 8.7 ± 1.6%. PCS improved significantly more in the MBS versus MLI group over 12 years (+2.37 ± 0.53 vs. -0.95 ± 0.73; difference 3.32 ± 0.85; P < 0.001). MBS was associated with better general health (P < 0.001), physical functioning (P = 0.001), and vitality (P = 0.003). Reduction in BMI was greater after MBS versus MLI (P < 0.001) and correlated with improved PCS (r = -0.43; P < 0.001). Change in PCS was not associated with change in HbA1c. MCS changed minimally from baseline and was similar between MBS and MLI groups during follow-up (-0.21 ± 0.61 vs. -0.89 ± 0.84; difference 0.68 ± 0.97; P = 0.48). Improvements in HU were greater in the MBS versus MLI group over 12 years (+0.02 ± 0.01 vs. -0.01 ± 0.01; difference 0.03 ± 0.01; P = 0.003).

Metabolic surgery produces sustained weight loss and improves PCS, general health, physical functioning, vitality, and HU in individuals with type 2 diabetes and obesity compared with medical therapy up to 12 years after intervention.

Friedreich Ataxia (FA) is a multisystem neurodegenerative disease. Affected individuals rely on mobility assistive technologies (MAT) (e.g. wheelchairs) and require long-term treatments and care. To analyse the patients' health-related quality of life (HRQoL), the EuroQol 5 Dimension 3 Level survey (EQ-5D-3L)-a widely used and recommended generic measure-is used in clinical and in health economic studies. Concerns about using the instrument in mobility-impaired individuals who might have difficulties finding appropriate response options for mobility-related items led us to investigate how the 3L dimensions perform in patients with FA using or not using MAT.

Using longitudinal data from 607 patients with FA of the EFACTS study (from baseline to the 3-year follow-up), we analysed the acceptability, distribution properties, validity, and responsiveness of the EQ-5D-3L, focusing on the mobility item. Analyses were stratified for patients without and with different MAT-usage.

We identified that n = 177 patients used no MAT, n = 299 a wheelchair and n = 131 walking aids. The mobility item non-response was highest in wheelchair users (6.8%) and lowest in patients without MAT. Walking aid users showed the least variability, all selecting the mid-response option "some problems" for mobility. The mobility item correlated moderately with disease severity (rsp = 0.35) and the activities of daily living scale (rsp = 0.36) in wheelchair users. No correlation exists for walking aid users. The strongest health changes occurred for wheelchair users, the weakest for walking aid users. The mobility dimensions showed the highest amount of no changes.

The EQ-5D-3L's mobility item has limitations in MAT users, particularly in walking aid users, due to a tendency towards mid-responses. These limitations may affect the efficacy and (cost)effectiveness conclusions drawn from interventions and clinical trials with mobility-impaired individuals. Further research is needed to explore the understanding and interpretation of responses of the EQ-5D in patients with FA with mobility support.

ClinicalTrials.gov identifier NCT02069509.

Aim: To estimate the cost-effectiveness of cetuximab in combination with radiotherapy compared with radiotherapy alone, for the treatment of locally advanced head and neck cancer patients in Spain. Methods: A probabilistic Markov model (second-order Monte Carlo simulation) with a five-year time horizon and quarterly Markov cycles was performed from the perspective of the Spanish National Health System (NHS). Results: The additional cost and quality-adjusted life-year (QALY) gain per patient receiving radiotherapy in combination with cetuximab compared with radiotherapy alone was €4356 (95% CI: €4350-4362) and 0.2380 (95% CI: 0.2370-0.2391) QALY, respectively. The incremental cost per QALY gain was €18,303 (95% CI: €18,243-18,354) with a probability of cost-effectiveness of 65.4% for a willingness to pay of €30,000 per QALY gained. Conclusion: According to the results of this analysis, the addition of cetuximab to radiotherapy would be a cost-effective alternative to radiotherapy alone in the treatment of locally advanced head and neck cancer in Spain.

In previous efforts, health-related quality of life (HRQoL) improved for individuals at high risk of type 2 diabetes and cardiovascular disease after participation in community-based lifestyle interventions (LI) with a moderate-to-vigorous physical activity (MVPA) movement goal.

It is unknown whether HRQoL improves with LI when the primary movement goal is to reduce sedentary behavior. HRQoL changes were examined among adults with overweight and prediabetes and/or metabolic syndrome randomized to a 12-month Diabetes Prevention Program-based Group Lifestyle Balance (DPP-GLB) community LI work with goals of weight-loss and either increasing MVPA (DPP-GLB) or reducing sedentary time (GLB-SED).

Study participants (N = 269) completed the Euroqol 5 dimension 3 long (EQ5D-3L index and EuroQol Visual Analog Scale (EQVAS)-visual analog scale) at baseline, and 6 and 12 months. Paired t-tests were used to evaluate pre-to-post-intervention changes by arm.

Mean EQVAS improvements for the GLB-SED arm at 6 and 12 months were +5.6 (SE = 1.3; P < .0001) and +4.6 (SE = 1.4; P = .0006), respectively. Similar mean EQVAS improvements were reported for the DPP-GLB arm; +5.9 (SE = 1.2; P < .0001) and +4.9 (SE = 1.2; P = .0001) at 6 and 12 months, respectively. Mean EQ5D index improvements were significant in the GLB-SED arm [6 months: +0.03 (SE = 0.01; P = .004); and 12 months: +0.04 (SE = 0.01; P = .006)], but not in the DPP-GLB arm.

Participation in community LI with a primary movement goal to reduce sedentary behavior improved HRQoL at least as well as traditional LI focused more on MVPA improvement, supporting an alternate intervention strategy for those who can't or won't engage in MVPA as the primary movement goal.

This study aimed to identify a preference-based health-related quality of life (HRQOL) measure that best reflects disease-specific features in patients with neck pain by comparing the characteristics of the instruments.

Pooled data from three multicentre randomised controlled clinical trials (RCTs) on neck pain were included for analysis in this study.

All three RCTs were conducted between 2017 and 2020 in Korea, and patients were recruited from four hospitals and one university teaching hospital.

In total, 313 patients with neck pain were included in the three RCTs.

A correlation analysis was conducted using Spearman's correlation coefficients between preference-based HRQOL scores (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) and Short-Form 6-Dimension version 1 (SF-6Dv1)) and the disease-specific measures for pain and function (Numerical Rating Scale (NRS), Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Northwick Park Questionnaire).

Spearman's correlation analyses (p value <0.01 for all) showed that EQ-5D-5L exhibited slightly stronger negative correlations with pain-related measures (VAS: -0.277, NRS: -0.262) compared with SF-6Dv1 (VAS: -0.207, NRS: -0.182). For functional outcomes, EQ-5D-5L demonstrated stronger negative correlations with function-related measures such as NDI (-0.636 to -0.711) compared with SF-6Dv1 (-0.506 to -0.579). In patients with moderate-to-severe neck pain (VAS>5), EQ-5D-5L appeared to better capture functional and pain aspects. Despite these differences, both instruments consistently reflected treatment-related improvements in pain and function. Distribution analysis further indicated that EQ-5D-5L and SF-6Dv1 were not fully interchangeable due to variations in domain-level scoring patterns and ceiling effects observed in EQ-5D-5L.

EQ-5D-5L showed stronger negative correlations with both pain and functional outcomes compared with SF-6Dv1, suggesting that it may better capture the functional aspects of chronic neck pain, particularly in moderate-to-severe conditions. However, the ceiling effect observed in EQ-5D-5L warrants caution when interpreting results in patients with mild neck pain. These findings provide practical guidance for selecting preference-based HRQOL measures in economic evaluations of musculoskeletal conditions, supporting more informed healthcare decision-making.Trial registration numberNCT03294785, Post-results; NCT03558178, Results; NCT04035018, Post-results.

As one of the main goals of hip and knee replacements is to improve patients' health-related quality of life, a meaningful evaluation can be achieved by calculating minimal important changes (MICs) for improvements in patient-reported outcome measures (PROMs). This study aims at providing MICs adjusted for patient characteristics for EQ-5D-3L index score improvements after hip and knee replacements. It adds to existing literature by relying on a large national sample and precise clustering algorithms, and by employing a state-of-the-art methodology for the calculation of improved adjusted MICs.

A retrospective observational study was conducted using the publicly available National Health Service (NHS) PROMs dataset for primary hip and knee replacements. We used information on 252,331 hip replacements and 279,668 knee replacements from all NHS-funded providers in England between 2013 and 2020. Clusters of patients were created based on pre-operative EQ-VAS, depression status, and sex. Unstratified and stratified estimates for meaningful EQ-5D-3L improvements were obtained through anchor-based predictive MICs corrected for the proportion of improved patients and the reliability of transition ratings.

Stratifying patients showed that MICs varied across subgroups based on pre-operative EQ-VAS, depression status, and sex. MICs were larger for patients with worse pre-operative EQ-VAS scores, while patients with better pre-operative scores required smaller MICs to achieve a meaningful change. We show how after stratification the percentage of patients achieving their stratified MIC was better in line with the actual share of improved patients. Larger MICs were found for patients with depression and for female patients. MICs calculated for knee replacements were consistently lower than those for hip replacements.

Our findings show the importance of adjusting MICs for patients' characteristics and should be considered for quality-related choices and policy initiatives.

The objective of this study is to compare different information retrieval methods that can be used to identify utility inputs for health economic models.

The usual practice of using systematic review methods was compared with two alternatives (iterative searching and rapid review), using a health technology assessment (HTA) case study in ulcerative colitis (UC). We analysed whether there were differences in the utility values identified when using the alternative search methods. Success was evaluated in terms of time, burden and relevance of identified information. The identified utility values were tested in an executable health economic model developed for UC, and the model results were compared.

The usual practice of using systematic review search approaches identified the most publications but was also the least precise method and took longest to complete. The inclusion of data from the different search methods in the model did not lead to different conclusions across search methods.

In this case study, usual practice was less efficient and resulted in the same health economic model conclusions as the alternative search methods. Further case studies are required to examine whether this conclusion might be generalisable.

The epidemiology data and global burden of diabetic foot disease underscores the need for effective prevention strategies, which requires an early diagnosis. Patient-reported outcome measures are instruments based on a simple format, which favours their application. Currently, there is an absence of instruments with a broad enough scope to capture the diverse aspects involved in diabetic foot disease.

To develop a questionnaire for the assessment of patients with diabetic foot disease and carry out an analysis of its validity and reliability.

The study was developed in two stages. Stage 1: the Delphi Panel was composed of 22 experts. The questionnaire is made up of 25 questions selected, after three rounds, from an initial sample of 68 questions. Stage 2: A validation study was performed. With a sample of 273 subjects, an exploratory factor analysis and an analysis of internal consistency, items response, and validity were carried out using the Diabetes Quality of Life, SF-12v2, Foot Function Index and EuroQol EQ5D questionnaires. Measurements of error and sensitivity to change were also analyzed.

A 25-item questionnaire (DiaFootQ) was developed. It comprised two dimensions: 1) lifestyle and function; and 2) footwear and foot self-care. Sample (n=273) mean age was 69.77 years (±11.08). The internal consistency of DiafootQ was α=0.916, and item response values were ICC=0.862-0.998. External validity correlation levels ranged from r=0.386 to r=0.888.

DiaFootQ was developed. Integrating the main aspects involved in diabetic foot disease could help to detect more accurately the risk or severity of these patients. DiaFootQ is a well-structured, valid, and reliable tool whose use should be promoted in clinical and research settings.

Patient-reported outcome measures (PROMs) have emerged as a promising approach to involve patients in their treatment process. Beyond serving as outcome measures, PROMs can be applied to provide feedback to healthcare providers and patients, thereby offering valuable insights that can improve health outcomes and care processes. This overview offers a comprehensive synthesis of the effects of PROM feedback, contributing to the evidence-based discussion on PROMs' potential to enhance patient care.

Following Cochrane Collaboration recommendations, this overview included literature reviews across diverse treatment areas, investigating the impact of PROM feedback on patient health outcomes (including quality of life, symptoms, or survival) and care process outcomes (including communication, symptom identification, or clinical practice). The methodological quality of the evidence was assessed with a modified version of A Measurement Tool to Assess Systematic Reviews 2, and the potential overlap of primary studies was quantified. Results were narratively synthesized.

Forty reviews grouped into 4 categories of treatment areas were included. Overall, their methodological quality was low. The overall overlap of primary studies was 2.2%, reaching up to 15.7% within specific treatment areas. The results indicate that PROM feedback may enhance the quality-of-care processes, whereas its effects on patient health outcomes remained less conclusive.

PROM feedback positively influences the interaction between physicians and patients across the included treatment areas. Further research is needed to comprehend the trickle-down effects of PROM feedback and how to enhance its potential in yielding health benefits for patients.

The SF-6D health descriptive system and its second version published in 2020, the SF-6Dv2, is used worldwide for valuing health-related quality of life (HRQoL) for economic evaluation and measuring patient-reported health outcomes. In this study, a valuation tool was developed and applied to create a social value set, comprising 18,750 health state values, for the SF-6Dv2 for New Zealand (NZ). This tool was adapted and extended from the one used to create a social value set for the EQ-5D-5L, a simpler health descriptive system with fewer dimensions and health states. The tool implements the PAPRIKA method, a type of adaptive discrete choice experiment, and a binary search algorithm to identify health states worse than dead and has extensive data quality controls to ensure the validity and reliability of the social value set derived from participants' personal value sets. The tool, accompanied by a short introductory video designed specifically for the SF-6Dv2, was distributed via an online survey to a large representative sample of adult New Zealanders in June-July 2022. The tool's data quality controls enabled participants who failed to understand or sincerely engage with the valuation tasks to be identified and excluded, resulting in the participants being pared down to a sub-sample of 2985 'high-quality' participants whose personal value sets were averaged for the social value set. These results, including participants' positive feedback, demonstrate the feasibility and acceptability of using the tool to value larger health descriptive systems such as the SF-6Dv2. Having successfully created an SF-6Dv2 social value set for NZ, the valuation tool can be readily applied to other countries, used to generate personal value sets for personalised medicine and adapted to create value sets for other health descriptive systems.

There are limited studies comparing the health utility values of EQ-5D-5L and SF-6Dv2 within the same patient cohorts. The widespread transmission and recurring infections associated with Omicron variants amid the COVID-19 pandemic have resulted in substantial health detriments and increased utilisation of health care resources. This highlights the crucial need to assess the loss in quality-adjusted life years (QALYs). Therefore, this study aims to compare the ceiling and floor effects, agreement, correlation and responsiveness between EQ-5D-5L and SF-6Dv2 based on COVID-19 patients during the Omicron outbreak in China.

We recruited 694 COVID-19 patients across mainland China to participant in an online questionnaire survey from January to February 2023. The questionnaire encompassed queries concerning the sociodemographic and health details of the participants, who were requested to recollect their health status during and after experiencing COVID-19 using the EQ-5D-5L and SF-6Dv2 questionnaires. Epanechnikov kernel density plots were used to visualise the ceiling and floor effects for both instruments. Agreement was assessed by Bland-Altman graph and intraclass correlation coefficient (ICC). Correlation was evaluated using linear regression, Pearson's correlation and Spearman's correlation. The standardised response mean (SRM) and relative efficiency (RE) were used to examine the responsiveness of EQ-5D-5L and SF-6Dv2 at detecting the health improvement after COVID-19 infection and the difference in dichotomous health indicators.

In total, 648 valid responses from patients aged 35.6 ± 15.0 years were involved in analysis. The EQ-5D-5L utility indices were 0.58 ± 0.33 and 0.92 ± 0.14 during and after COVID-19 infection, respectively, which were significantly higher than indices of the SF-6Dv2 utility (0.43 ± 0.31 and 0.81 ± 0.19, p < 0.001). A ceiling effect of EQ-5D-5L larger than that of SF-6Dv2 was observed during COVID-19 infection (49.5% vs 21.6%). Intraclass correlation coefficients between EQ-5D-5L and SF-6Dv2 during and after COVID-19 infection were 0.69 and 0.55, respectively. The utility indices of EQ-5D-5L and SF-6Dv2 were highly correlated, with Pearson's correlation coefficients of 0.76 and 0.70 (p < 0.001) during and after COVID-19 infection, respectively. The spearman's correlations were moderate to high between dimensions of EQ-5D-5L and SF-6Dv2 (p < 0.01). Both EQ-5D-5L and SF-6Dv2 were responsive to detect health improvement after COVID-19 and the differences in dichotomous health indicators.

The utility indices generated by EQ-5D-5L and SF-6Dv2 in COVID-19 patients demonstrate strong correlation and responsiveness. However, the agreement between these two instruments does not reach a satisfactory level. Consequently, these two measures cannot be used interchangeably. In situations where apprehensions about ceiling effects affecting outcome measurement arise, it is advisable to consider SF-6Dv2 as a preferable outcome measure for studies on patients with COVID-19.

This review aims to examine the ceiling effects of EQ-5D-3L (3L) and EQ-5D-5L (5L) in general adult populations and identify the factors influencing these effects.

We searched 8 databases for observational studies published in English from inception to 24 July 2023. Ceiling effects were calculated by dividing the number of participants reporting full health at dimension or profile level by the total sample size. Subgroup analysis and meta-regression using the metafor package in R software were performed.

We identified 94 studies from 70 articles, including 4 543 647 adults across 37 countries. The global pooled proportion of individuals reporting full health ("11111") was 56% (95% CI 51%-62%) for 3L and 49% (95% CI 44%-54%) for 5L. The self-care dimension showed the highest ceiling effects (3L: 97%; 5L: 94%), whereas pain/discomfort had the lowest (3L: 69%; 5L: 60%). The ceiling effects in East/South-East Asia were higher than in Europe by 25% (95% CI 18%-32%) in 3L and 9% (95% CI -2%-20%) in 5L. Adjusting for mean age and proportion of males, significant regional differences persisted in the overall profile level of 3L, in all 3L dimensions (except for self-care), and 5L dimensions (except for pain/discomfort and anxiety/depression).

This review highlights significant ceiling effects in the EQ-5D, especially in Asian populations. The 5L version exhibited fewer ceiling effects than the 3L, indicating its superiority for general population surveys. Further research is crucial to understand the disparities in self-reported health outcomes between Asians and other populations.

Assessment of quality of life (QoL) in people living with sleep disorders using questionnaires is necessary to compare intervention benefits. Knowledge of the content and concepts covered by specific QoL instruments is essential to determine which instruments are best suited for conducting economic evaluations of sleep-related interventions.

This review aims to identify the QoL instruments that have been applied in economic evaluations of sleep disorder interventions and compare their conceptual overlap and content coverage using the framework of the International Classification of Functioning, Disability and Health (ICF).

A systematic review of full economic evaluations in sleep published in peer-reviewed journals from conception to 30 May, 2023 was conducted. MEDLINE, PsychInfo, ProQuest, Cochrane, Scopus, CINAHL, Web of Science and Emcare were searched for eligible studies. Studies incorporating either generic or sleep-specific QoL instruments as the primary or secondary measures of effectiveness within a full economic evaluation were included. Quality appraisal against the JBI Critical Appraisal Checklist for Economic Evaluations and EURONHEED checklists and mapping of QoL items to ICF categories were performed by two reviewers, with a third helping settle any potential differences.

Sixteen instruments were identified as having been used in sleep health economic evaluations. The EQ-5D-3L, Epworth Sleepiness Scale, and Insomnia Severity Index were the most widely used, but the latter two are predominantly diagnostic tools and not specifically designed to guide economic evaluations. Other instruments with broader ICF content coverage have been least used, and these include the Sleep Apnea Quality of Life Index, Functional Outcomes of Sleep Questionnaire, 15 Dimensions, Short-Form 6 Dimensions, 12-item Short Form Survey, 36-item Short Form Survey and the GRID Hamilton Rating Scale for Depression.

This study provides an overview of current QoL instruments used in economic evaluations of sleep with respect to their content coverage. A combination of generic and sleep-specific instruments with broader ICF content coverage is recommended for such evaluations.

Problem gambling can lead to health-related harms, such as poor mental health and suicide. In the UK there is interest in introducing guidance around effective and cost-effective interventions to prevent harm from gambling. There are no estimates of the health state utilities associated with problem gambling severity from the general population in the UK. These are required to determine the cost-effectiveness of interventions. This study aims to use an indirect elicitation method to estimate health state utilities, using the EQ-5D, for various levels of problem gambling and gambling-related harm.

We used the Health Survey for England to estimate EQ-5D-derived health state utilities associated with the different categories of the Problem Gambling Severity Index (PGSI), PGSI score and a 7-item PGSI-derived harms variable. Propensity score matching was used to create a matched dataset with respect to risk factors for problem gambling and regression models were used to estimate the EQ-5D-derived utility score and the EQ-5D domain score whilst controlling for key comorbidities. Further exploratory analysis was performed to look at the relationship between problem gambling and the individual domains of the EQ-5D.

We did not find any significant attributable decrements to health state utility for any of the PGSI variables (categories, score and 7-item PGSI derived harms variable) when key comorbidities were controlled for. However, we did find a significant association between the 7-item PGSI derived harms variable and having a higher score (worse health) in the anxiety/depression domain of the EQ-5D, when comorbidities were controlled for.

This study found no significant association between problem gambling severity and HRQoL measured by the EQ-5D when controlling for comorbidities. There might be several reasons for this including that this might reflect the true relationship between problem gambling and HRQoL, the sample size in this study was insufficient to detect a significant association, the PGSI is insufficient for measuring gambling harm, or the EQ-5D is not sensitive enough to detect the changes in HRQoL caused by gambling. Further research into each of these possibilities is needed to understand more about the relationship between problem gambling severity and HRQoL.

To explore the comparative performance and develop the mapping algorithms between EQ-5D-5L and SF-6Dv2 in China.

Respondents recruited from the Chinese general population completed both EQ-5D-5L and SF-6Dv2 during face-to-face interviews. Ceiling/floor effects were reported. Discriminative validity in self-reported chronic conditions was investigated using the effect sizes (ES). Test-retest reliability was evaluated using intra-class correlation coefficient (ICC) and Bland-Altman plots in a subsample. Correlation and absolute agreements between the two measures were estimated with Spearman's rank correlation coefficient and ICC, respectively. Ordinary least squares (OLS), generalized linear model, Tobit model, and robust MM-estimator were explored to estimate mapping equations between EQ-5D-5L and SF-6Dv2.

3320 respondents (50.3% males; age 18-90 years) were recruited. 51.1% and 12.2% of respondents reported no problems on all EQ-5D-5L and SF-6Dv2 dimensions, respectively. The mean EQ-5D-5L utility was higher than SF-6Dv2 (0.947 vs. 0.827, p < 0.001). Utilities were significantly different across all chronic conditions groups for both measures. The mean absolute difference of utilities between the two tests for EQ-5D-5L was smaller (0.033 vs. 0.043) than SF-6Dv2, with a slightly higher ICC (0.859 vs. 0.827). Fair agreement (ICC = 0.582) was observed in the utilities between the two measures. Mapping algorithms generated by the OLS models performed the best according to the goodness-of-fit indicators.

Both measures showed comparable discriminative validity. Systematic differences in utilities were found, and on average, the EQ-5D-5L generates higher values than the SF-6Dv2. Mapping algorithms between the EQ-5D-5L and SF-6Dv2 are reported to enable transformations between these two measures in China.

Current classification systems based on bowel habit fail to capture the multidimensional nature of irritable bowel syndrome (IBS). We previously derived and validated a classification system, using latent class analysis, incorporating factors beyond bowel habit. We applied this in another cohort of people with IBS to assess its ability to capture the impact of IBS on the individual, the health care system, and society.

We collected demographic, symptom, and psychological health data from adults in the community self-identifying as having IBS, and meeting Rome IV criteria. We applied our latent class analysis model to identify the 7 subgroups (clusters) described previously, based on overall gastrointestinal symptom severity and psychological burden. We assessed quality of life, health care costs (£1 = $1.20), employment status, annual income, work productivity, and ability to perform work duties in each cluster.

Of 1278 responders, 752 (58.8%) met Rome IV criteria. The 7-cluster model fit the data well. The patients in the 4 clusters with the highest psychological burden, and particularly those in cluster 6 with high overall gastrointestinal symptom severity and high psychological burden, showed lower educational levels, higher gastrointestinal symptom-specific anxiety, were more likely to have consulted a gastroenterologist, and used more drugs for IBS. IBS-related and generic quality of life were impaired significantly in these 4 clusters and significantly fewer individuals reported earning ≥£30,000 per year. Productivity and the ability to work, manage at home, engage in social and private leisure activities, and maintain close relationships all were impacted significantly, and IBS-related health care costs over the previous 12 months were highest in these 4 clusters. In those in cluster 6, costs were more than £1000 per person per year.

Our clusters identify groups of individuals with significant impairments in quality of life, earning potential, and ability to work and function socially, who are high utilizers of health care.

This study investigates the relationship between long COVID and health-related quality of life (HRQOL) in patients discharged for 6 months. It included 192 patients with a history of severe COVID-19 and 192 patients with a history of non-severe COVID-19 patients that were selected through quota sampling methods from the Medical Care Monitoring Center (MCMC) of hospitals in Shiraz, Iran, in 2020. Phone-based interviews were conducted to collect data using the short form of the 12-item health-related quality of life (SF-12) questionnaire. Descriptive statistics, including mean (standard deviation) and frequency (percentage), were utilized. Statistical tests, such as the chi-squared test, independent samples t-test, Fisher's exact test, and multiple linear regression models were performed. Statistical analysis was performed using SPSS software version 24, with a significance level of 0.05. Among 384 patients, 79.95% were married, with a mean age of 53.95 years. The majority of patients in both groups were male (57.81% in the severe group and 51.04% in the non-severe group). Patients with severe COVID-19 had significantly lower quality of life scores compared to those with non-severe COVID-19 (p < 0.001, 34.45 [SD = 6.59] versus 39.64 [SD = 5.07]). Furthermore, multiple linear regression analysis indicated that severe COVID-19 inducts a significant negative effect on HRQOL in patients after adjustment of confounders (p < 0.001, B =  - 4.84). Patients with severe COVID-19 had lower HRQOL compared to those with a non-severe level. It is necessary to consider implementing policies aimed at providing social, psychological, or medical support to improve the HRQOL of patients with a history of severe COVID-19.

The utility measure is a method to quantify health-related quality of life according to the preference values that patients attach to their health status. This study aimed to estimate the utility measure of patients with controlled and uncontrolled severe asthma (SA) in Spain, separately. Additionally, other characteristics (sociodemographic, clinical, and healthcare resource use [HCRU]) were also assessed for both SA populations.

This cross-sectional study included 159 patients with SA in Spain. Data were collected from medical records and directly from the patients during the study visit. Asthma Control Questionnaire (ACQ)-5 was used to classify patients with controlled and uncontrolled SA.

Most of the patients were female (72.0% uncontrolled SA and 63.6% controlled SA). The mean (SD) EuroQol-5D (EQ-5D-5L) score was 0.88 (0.14) and 0.70 (0.25) in controlled and uncontrolled SA, respectively. The mean (SD) Asthma Quality-of-Life-5D (AQL-5D) score was 0.93 (0.09) and 0.85 (0.09) in controlled and uncontrolled SA, respectively. Emergency visits (19.2 vs. 2.7%) and hospitalizations (7.7% vs. no hospitalization) were more common among uncontrolled SA than controlled SA. Mean (SD) number of visits to primary care and pneumologists in uncontrolled SA vs. controlled SA was 4.1 (2.8) vs. 2.5 (3.0) and 3.7 (3.5) vs. 2.8 (2.2), respectively.

The study provides data on utility measures among patients with SA in Spain for the first time. Patients with uncontrolled SA had lower HRQoL and higher HCRU than patients with controlled SA. Therefore, the implementation of measures that improve HRQoL among patients with uncontrolled SA is highly recommended.

To measure the health spillover effect in caregivers of patients with multiple sclerosis (MS), we aimed to select the best instrument from 2 common health-related quality of life (QoL) instruments, the 3-level EQ-5D (EQ-5D-3L) and the Health Utilities Index Mark 3 (HUI-3), by assessing them.

Using consecutive sampling, 452 primary caregivers of patients with MS were asked to fill out a Care-related QoL instrument (CarerQol-7D), EQ-5D-3L, HUI-3, and the Center for Epidemiologic Studies Depression Scale between October 2019 and May 2020. Convergent and clinical validity were assessed to measure spillover effect in caregivers of patients with MS.

A strong correlation of health-utility scores between EQ-5D-3L and HUI-3 (r = 0.914, P < .01) was observed. The 95% limit of agreement (LoA) for CarerQol-7D and HUI-3 (-10.6 to 8.2) was narrower than the LoA for CarerQol-7D and EQ-5D-3L (-15.1 to 17.1). Both EQ-5D-3L and HUI-3 proved clinical validity for the QoL of caregivers. The CarerQoL-7D score was significantly lower in female (P < .001), single (P < .014), lower-educated (P < .001), parent's relatives (P < .001), and unemployed (P < .001) caregivers.

We found that both, EQ-5D-3L and HUI-3, were appropriate for measuring caregivers' QoL, although HUI-3 was a better choice because of its narrower LoA. Our findings suggest researchers should use HUI-3 to measure the quality-adjusted life-year of caregivers to aggregate with the QoL of patients in the denominator of an economic evaluation equation, such as the cost-effective ratio.

This study assessed patient-reported health-related quality of life (HRQoL) using two generic preference-based measures in Chinese patients with spinal and bulbar muscular atrophy (SBMA) and identified demographic and clinical determinants of health utility scores in this population.

This study used cross-sectional data of 212 Chinese patients with SBMA who completed both the EQ-5D and SF-6D. Association between response to EQ-5D and SF-6D dimensions was examined using Spearman's correlation coefficient, and the association between the two utility scores was assessed using Pearson's correlation coefficient. The variations in utility scores across patients in different subgroups were compared using one-way ANOVA. Bland-Altman (B-A) plot was used to assess the agreement of utility scores between EQ-5D and SF-6D. A multivariate Tobit regression model was employed to estimate the association between utility scores and the presence of symptoms and chronic conditions.

The mean utility scores for the EQ-5D and SF-6D were 0.54 and 0.56, respectively. The hypothesized correlation between the EQ-5D and SF-6D dimensions ranged from 0.31 to 0.58, and the correlation between their utility scores was 0.64. An acceptable agreement between EQ-5D and SF-6D utility scores was identified by B-A plot. Patients with chronic diseases, misdiagnosis, high financial burden, and several clinical symptoms were highly likely to report a low health utility score.

This study is the first to investigate the HRQoL of patients with SBMA worldwide. The estimated health utility scores for EQ-5D and SF-6D can be utilized as baseline data for future cost-utility analyses of SBMA-related interventions.

There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.

Participant engagement in an online physical activity (PA) intervention is described and baseline factors related to engagement are identified.

Longitudinal Study Within Randomized Controlled Trial.

Online/Internet.

Primary care patients (21-70 years).

ActiveGOALS was a 3-month, self-directed online PA intervention (15 total lessons, remote coaching support, and a body-worn step-counter).

Engagement was measured across six outcomes related to lesson completion (total number and time to complete), coach contact, and behavior tracking (PA, sedentary). Self-reported baseline factors were examined from seven domains (confidence, environment, health, health care, demographic, lifestyle, and quality of life).

General linear and nonlinear mixed models were used to examine relationships between baseline factors and engagement outcomes within and across all domains.

Seventy-nine participants were included in the sample (77.2% female; 74.7% white non-Hispanic). Program engagement was high (58.2% completed all lessons; PA was tracked ≥3 times/week for 11.3 ± 4.0 weeks on average). Average time between completed lessons (days) was longer than expected and participants only contacted their coach about 1 of every 3 weeks. Individual predictors related to health, health care, demographics, lifestyle, and quality of life were significantly related to engagement.

Examining multiple aspects of engagement and a large number of potential predictors of engagement is likely needed to determine facilitators and barriers for high engagement in multi-faceted online intervention programs.

A high-quality and widely accepted UK EQ-5D-5L value set is urgently required to enable the latest version of EQ-5D scored using recent UK public preferences to inform policy including health technology assessments submitted to the National Institute for Health and Care Excellence. This article outlines the study protocol for the generation of a new EQ-5D-5L UK value set.

Twelve hundred interviews will be undertaken using the composite time trade-off elicitation technique for 102 health states (86 from the international EQ-5D-5L valuation protocol, plus 16 with best predictive performance in an extended design used in the Native American EQ-5D-5L valuation). The sample will be UK adults (age ≥18 years) proportionately representative across England, Wales, Scotland, and Northern Ireland, representative for age, sex, ethnicity, and socioeconomic group, with inclusion of participants with/without health problems. Participants will choose to be interviewed via videoconference (by Zoom) or in-person in a central venue. Data quality will be rigorously assessed.

The value set will be generated using tobit random effects and heteroscedastic tobit models (with censoring at -1) using all data, excluding time trade-off values highlighted by participants as ones they would reconsider and data from interviewers failing protocol compliance. Quality and acceptance will be achieved by public involvement, regular Steering Group meetings, independent assessment of data quality at 4 time points, and final endorsement of data and analyses.

This study will produce a UK value set for the EQ-5D-5L for use in prospective and retrospective data sets containing EQ-5D-5L data.

Patient-reported outcome measures (PROMs) are commonly collected in trials and some care settings, but preference-based PROMs required for economic evaluation are often missing. For these situations, mapping models are needed to predict preference-based (aka utility) scores. Our objective is to develop a series of mapping models to predict preference-based scores from two mental health PROMs: Patient Health Questionnaire-9 (PHQ-9; depression) and Generalised Anxiety Questionnaire-7 (GAD-7; anxiety). We focus on preference-based scores for the more physical-health-focussed EQ-5D (five-level England and US value set, and three-level UK cross-walk) and more mental-health-focussed Recovering Quality-of-Life Utility Index (ReQoL-UI).

We used trial data from the Improving Access to Psychological Therapies (IAPT) mental health services (now called NHS Talking Therapies), England, with a focus on people with depression and/or anxiety caseness. We estimated adjusted limited dependent variable or beta mixture models (ALDVMMs or Betamix, respectively) using GAD-7, PHQ-9, age, and sex as covariates. We followed ISPOR mapping guidance, including assessing model fit using statistical and graphical techniques.

Over six data collection time-points between baseline and 12-months, 1340 observed values (N ≤ 353) were available for analysis. The best fitting ALDVMMs had 4-components with covariates of PHQ-9, GAD-7, sex, and age; age was not a probability variable for the final ReQoL-UI mapping model. Betamix had practical benefits over ALDVMMs only when mapping to the US value set.

Our mapping functions can predict EQ-5D-5L or ReQoL-UI related utility scores for QALY estimation as a function of variables routinely collected within mental health services or trials, such as the PHQ-9 and/or GAD-7.

Improving survival and health-related quality of life (HRQOL), along with symptom relief, is important for the treatment of metastatic breast cancer (MBC). This study measured HRQOL and analyzed its influence on sociodemographic and clinical factors in patients with MBC.

We interviewed 298 patients with MBC to investigate their sociodemographic characteristics and HRQOL by using EuroQol-5D-5L (EQ-5D) between September and October 2014. We also reviewed medical records to examine the clinical condition of the patients, including disease progression, adverse events, treatments, chronic disease, and metastatic areas. The distribution of the EQ-5D index was compared between different clinical conditions by using the Kruskal-Wallis test. We also conducted multiple regression analyses to identify the factors affecting HRQOL in patients with MBC.

The mean EQ-5D index was 0.79 for all patients surveyed. The mean EQ-5D index score was significantly lower in patients in the progressed state than in those in the progression-free survival state (0.73 vs. 0.80, p = 0.0002). The HRQOL of patients treated with chemotherapy alone was significantly lower than that of patients treated with hormonal or targeted therapy (0.76 vs. 0.82 or 0.85; p = 0.0020). Regression analysis revealed that the clinical factors associated with lower HRQOL were progressed state, chemotherapy, and adverse events, such as hair loss or stomatitis. Finally, young age, high income, and employment were the sociodemographic factors that were positively associated with better HRQOL.

This study provides new information on the health utility of MBC patients on the basis of various patient characteristics and offers insights that can assist medical professionals in treating patients with MBC and help policymakers implement cancer strategies. Further research is needed to reflect the changing environment of cancer treatment and enrich available evidence.

Databases have become an important tool in understanding trends and correlations in health care by collecting demographic and clinical information. Analysis of data collected from large cohorts of patients can have the potential to generate insights into factors identifying treatments and the characteristics of subgroups of patients who respond to certain types of care. The Care Response (CR) database was designed to capture patient-reported outcome measures (PROMs) for chiropractic patients internationally. Although several papers have been published analysing some of the data, its contents have not yet been comprehensively documented. The primary aim of this study was to describe the information in the CR database. The secondary aim was to determine whether there was suitable information available to better understand subgroups of chiropractic patients and responsiveness to care. This would be achieved by enabling correlations among patient demographics, diagnoses, and therapeutic interventions with machine learning approaches.

Data in all available fields were requested with no date restriction. Data were collected on 12 April 2022. The output was manually scanned for scope and completeness. Tables were created with categories of information. Descriptive statistics were applied.

The CR database collects information from patients at the first clinical visit, 14, 30, and 90 days subsequently. There were 32,468 patient responses; 3210 patients completed all fields through the 90 day follow up period. 45% of respondents were male; 54% were female; the average age was 49. There was little demographic information, and no information on diagnoses or therapeutic interventions. We received StartBack, numerical pain scale, patient global impression of change, and Bournemouth questionnaire data, but no other PROMs.

The CR database is a large set of PROMs for chiropractic patients internationally. We found it unsuitable for machine learning analysis for our purposes; its utility is limited by a lack of demographic information, diagnoses, and therapeutic interventions. However, it can offer information about chiropractic care in general and patient satisfaction. It could form the basis for a useful clinical tool in the future, if reformed to be more accessible to researchers and expanded with more information collected.

Quality-adjusted life-year instruments help comparison among programs by capturing their effects in terms of utility. Generic instruments are applicable to everyone, and for this reason, they are known to lack sensitivity when measuring gains in some domains. Specific instruments tend to fill this gap but, in domains like cancer, existing instruments are either nonpreferences-based or based on the general population's preferences.

This study describes the development of a new value set for a well-known and highly used generic instrument, the Second Version of the Short Form 6-Dimension, to better consider the preferences of patients with cancer. In this aim, a hybrid approach combining the time trade-off and the discrete choice experiment was used. The population of interest was the Quebec population, Canada, with breast or colorectal cancer. Their preferences were elicited in 2 periods: before (T1) and 8 days after the beginning of a chemotherapy procedure (T2).

A total of 2808 observations for the time trade-off and 2520 observations for the discrete choice experiment were used. The parsimonious model encompassing the 2 periods was the preferred model. The new value set allows a greater utility range than the EQ-5D-5L and the Second Version of the Short Form 6-Dimension reference value sets and helps in better considering patients experiencing severe health situations. A good correlation between these 2 instruments and other specific cancer instruments (ie, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, QLU-C10D, and Functional Assessment of Cancer Therapy-General) was observed. Significative differences in utility values were also noted within periods and types of cancer.

To compare long term outcomes after great saphenous vein (GSV) treatment with three radiofrequency (RF) thermal devices: Venefit (Closurefast), Radiofrequency Induced Thermal Therapy (RFITT), and Endovenous Radiofrequency (EVRF).

A 72 month follow up of patients who were treated in the randomised 3RF study.

A total of 172 participants from the 3RF study were invited to take part in a single visit, long term, follow up study. Failure of GSV closure was assessed with duplex ultrasound (DUS) and constituted the primary outcome. Patients completed questionnaires for secondary outcomes: Aberdeen Varicose Vein Questionnaire (AVVQ), Euroqol 5D (EQ-5D), and patient reported varicose veins measured by counting vein occupying boxes in AVVQ question 1.

Twenty-two patients (12%) had already been re-treated. Of the remainder, 13 (7%) could not be contacted, 20 (11%) declined invitation, and one did not consent. Therefore, 116 (64%) and 95 (53%) participants completed questionnaires and DUS, respectively. Failure of GSV closure on 72 month DUS was 16%, 21%, and 37% for Venefit, RFITT, and EVRF, respectively (p = .14), whilst outcomes for all failures were 14%, 17%, and 44% (p < .001) (Venefit vs. EVRF: p < .001; RFITT vs. EVRF: p < .001; and Venefit vs. RFITT: p = .63). There were no between group differences in AVVQ or EQ-5D scores. Rates of patient reported presence of any varicose veins were high for all groups (97%, 92%, and 97% after Venefit, RFITT, and EVRF, respectively; p = .48). The EVRF treated participants reported more extensive recurrence than the Venefit and RFITT participants (p = .008).

Long term technical outcomes after RF ablation for GSV varicose veins were significantly better after Venefit and RFITT compared with EVRF treatment. However, quality of life scores showed no differences after 72 months. Rates of patient reporting any varicose veins were high for all treatments.

gov Identifier: NCT04720027.

To analyze the cost-effectiveness of weekly somatrogon compared to daily growth hormones (GH-d) in the pediatric population of Spain with growth hormone deficiency (GHD).

Markov model with two states (patients with or without GH-d or somatrogon treatment) in prepubertal children (3 to 11 years and 3 to 12 years in girls and boys, respectively) with GHD in isolation or as part of multiple pituitary hormone deficiency and without previous treatment, from the perspective of the National Health System. The simulation of the economic model ends at the age of 18. The costs of hormones and monitoring were obtained from Spanish sources. The utilities were obtained from the literature. Spanish clinical experts validated the assumptions of the model.

In the deterministic analysis, somatrogon would be cost-effective, compared to GH-d, with a cost per QALY (quality-adjusted life year) gained of €19,259 and a clinically relevant QALY gain (0.336). This result was confirmed in deterministic sensitivity analyses. According to the probabilistic analysis, somatrogon would be the dominant treatment, with a 61% probability of a willingness to pay of €25,000 per QALY gained.

Compared to GH-d, somatrogon is cost-effective in the Spanish pediatric population with GHD.

We aimed to compare measurement properties of the 5-level version of EQ-5D (EQ-5D-5L) and 2 Patient-Reported Outcomes Measurement Information System (PROMIS) short forms, PROMIS-29+2 and PROMIS Global Health (PROMIS-GH-10), and of EQ-5D-5L and PROMIS-preference scoring system (PROPr) utilities.

A cross-sectional survey was conducted in a general population sample in Hungary (N = 1631). We compared the following measurement properties at the level of items, domains, and utilities, the latter using corresponding US value sets: ceiling and floor, informativity (Shannon's indices), agreement, convergent, and known-group validity. For the analyses, PROMIS items/domains were matched to EQ-5D-5L domains that cover similar concepts of health.

The majority of PROMIS items showed enhanced distributional characteristics, including lower ceilings and higher informativity than the EQ-5D-5L. Good convergent validity was established between EQ-5D-5L and PROMIS domains capturing similar aspects of health. Mean EQ-5D-5L utilities were substantially higher than those of PROPr (0.864 vs 0.535). EQ-5D-5L utilities correlated moderately or strongly with PROPr (r = 0.61), PROMIS-GH-10 physical (r = 0.68), and mental health summary scores (r = 0.53). EQ-5D-5L utilities decreased with age, whereas PROPr utilities slightly increased with age. EQ-5D-5L utilities discriminated significantly better in 12/28 (ratio of F-statistics) and 18/26 (area under the receiver-operating characteristics curve ratio) known groups defined by age, self-perceived health status, and self-reported physician-diagnosed health conditions, including hypertension, diabetes, coronary heart disease, chronic kidney disease, and stroke.

This study provides comparative evidence on the measurement properties of EQ-5D-5L, PROMIS-29+2, and PROMIS-GH-10 and informs decisions about the choice of instruments in population health surveys for assessment of patients' health and for cost-utility analyses.

Diabetes and obesity pose a significant burden for the U.S. military beneficiary population, creating a great need to provide evidence-based diabetes and obesity prevention services for military personnel, retirees, and their dependents. Despite increasing dissemination of the Diabetes Prevention Program (DPP) lifestyle intervention nationwide, formal evaluation of implementation of this highly successful program is limited in the military setting. The purpose of this study is to prospectively evaluate delivery of a direct adaptation of a 1-year DPP lifestyle intervention at a U.S. Air Force medical facility, Wright-Patterson Medical Center (WPMC), to determine the feasibility of delivery of the program in a group of at-risk active duty military, retirees, and family members, as well as assess effectiveness in improving weight and other risk factors for type 2 diabetes.

A pre/post study design was utilized to evaluate feasibility and effectiveness of the DPP Group Lifestyle Balance (GLB), an up-to-date, 22-session direct adaptation of the DPP curriculum, at WPMC. Participants chose to complete the 1-year program either in coach-led face-to-face groups or via DVD with weekly telephonic coach contact. The study was approved by the University of Pittsburgh and WPMC Institutional Review Boards.

A total of 99 individuals enrolled in the study, with 83 (84%) and 77 (78%) completing 6- and 12-month follow-up assessments, respectively. The mean age of participants at baseline was 57 (range 20-85 years), with 63% being female. The group was comprised of individuals who were non-Hispanic White (73.7%), non-Hispanic Black (18.2%), and other race or Hispanic ethnicity (8.1%). Within this group, there were 10 active duty military, 37 retirees, and 52 family members. The DPP-GLB program was shown to be feasible to implement in this military healthcare setting as demonstrated by the high engagement over the course of the year-long program. Significant improvements were shown in the two main behavioral goals: mean weight (-12.8 lbs, -6.3%, P < .001) and mean physical activity (PA) (+18.9 Met-hrs/wk, P < .001). In addition, significant improvements in other diabetes and cardiovascular risk factors including low-density lipoprotein cholesterol, fasting insulin, diastolic blood pressure, and waist circumference were noted, as well as improvement in health-related quality of life.

These results demonstrate that the DPP-GLB program delivered via face-to-face groups or DVD was feasible and effective in improving weight, PA levels, and diabetes and cardiovascular risk factors in this group of active and retired military personnel and their family members. The program was well received by the program participants as well as the WPMC team. These findings offer a model for provision of the DPP-GLB program throughout the Military Health System.

Virtual and low-touch behavioral interventions are needed for African American/Black and Latino persons living with HIV (PLWH) with barriers to HIV viral suppression, particularly during COVID-19. Guided by the multiphase optimization strategy, we explored three components for PLWH without viral suppression, grounded in motivational interviewing and behavioral economics: (1) motivational interviewing counseling, (2) 21-weeks of automated text messages and quiz questions about HIV management, and (3) financial rewards for viral suppression (lottery prize vs. fixed compensation).

This pilot optimization trial used sequential explanatory mixed methods to explore the components' feasibility, acceptability, and preliminary evidence of effects using an efficient factorial design. The primary outcome was viral suppression. Participants engaged in baseline and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. A subset engaged in qualitative interviews. We carried out descriptive quantitative analyses. Then, qualitative data were analyzed using directed content analysis. Data integration used the joint display method.

Participants (N = 80) were 49 years old, on average (SD = 9), and 75% were assigned male sex at birth. Most (79%) were African American/Black, and the remainder were Latino. Participants were diagnosed with HIV 20 years previously on average (SD = 9). Overall, components were feasible (>80% attended) and acceptability was satisfactory. A total of 39% (26/66) who provided laboratory reports at follow-up evidenced viral suppression. Findings suggested no components were entirely unsuccessful. The lottery prize compared to fixed compensation was the most promising component level. In qualitative analyses, all components were seen as beneficial to individual wellbeing. The lottery prize appeared more interesting and engaging than fixed compensation. However, structural barriers including financial hardship interfered with abilities to reach viral suppression. The integrated analyses yielded areas of convergence and discrepancy and qualitative findings added depth and context to the quantitative results.

The virtual and/or low-touch behavioral intervention components tested are acceptable and feasible and show enough potential to warrant refinement and testing in future research, particularly the lottery prize. Results must be interpreted in the context of the COVID-19 pandemic.

NCT04518241 (https://clinicaltrials.gov/ct2/show/NCT04518241).

The EQ-5D-5L and 15D are generic preference-accompanied health status measures with similar dimensions. In this study, we aim to compare the measurement properties of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample.

In August 2021, an online cross-sectional survey was conducted in a representative adult general population sample (n = 1887). The EQ-5D-5L and 15D descriptive systems and index values were compared in terms of ceiling and floor, informativity (Shannon's Evenness index), agreement, convergent and known-groups validity for 41 chronic physical and mental health conditions. Danish value sets were used to compute index values for both instruments. As a sensitivity analysis, index values were also estimated using the Hungarian EQ-5D-5L and Norwegian 15D value sets.

Overall, 270 (8.6%) and 1030 (3.4*10-6%) unique profiles occurred on the EQ-5D-5L and 15D. The EQ-5D-5L dimensions (0.51-0.70) demonstrated better informativity than those of 15D (0.44-0.69). EQ-5D-5L and 15D dimensions capturing similar areas of health showed moderate or strong correlations (0.558-0.690). The vision, hearing, eating, speech, excretion and mental function 15D dimensions demonstrated very weak or weak correlations with all EQ-5D-5L dimensions, which may indicate potential room for EQ-5D-5L bolt-ons. The 15D index values showed lower ceiling than the EQ-5D-5L (21% vs. 36%). The mean index values were 0.86 for the Danish EQ-5D-5L, 0.87 for the Hungarian EQ-5D-5L, 0.91 for the Danish 15D and 0.81 for the Norwegian 15D. Strong correlations were found between the index values (Danish EQ-5D-5L vs. Danish 15D 0.671, Hungarian EQ-5D-5L vs. Norwegian 15D 0.638). Both instruments were able to discriminate between all chronic condition groups with moderate or large effect sizes (Danish EQ-5D-5L 0.688-3.810, Hungarian EQ-5D-5L 1.233-4.360, Danish 15D 0.623-3.018 and Norwegian 15D 1.064-3.816). Compared to the 15D, effect sizes were larger for the EQ-5D-5L in 88-93% of chronic condition groups.

This is the first study to compare the measurement properties of the EQ-5D-5L and 15D in a general population sample. Despite having 10 fewer dimensions, the EQ-5D-5L performed better than the 15D in many aspects. Our findings help to understand the differences between generic preference-accompanied measures and support resource allocation decisions.

Little is known about associations with reduced quality of life in irritable bowel syndrome (IBS) or impact of IBS on quality of life compared with other chronic conditions.

We collected demographic, gastrointestinal and psychological symptoms, healthcare usage, direct healthcare costs, impact on work and activities of daily living data from 752 individuals with Rome IV-defined IBS. We used the irritable bowel syndrome quality of life (IBS-QOL) and the EQ-5D-5L questionnaires to examine characteristics associated with lower quality of life.

The mean IBS-QOL among all 752 individuals with Rome IV IBS was 48.4 (SD 22.3) and the mean EQ-5D score was 0.570 (SD 0.283), the latter being comparable to people with stroke, leg ulcers or chronic obstructive pulmonary disease. Lower levels of both disease-specific and generic quality of life were associated with severe IBS symptom scores, abnormal anxiety or depression scores, and higher somatoform symptom-reporting and gastrointestinal symptom-specific anxiety scores (p < 0.001 for all analyses). Those with lower quality of life had significantly higher healthcare usage and direct healthcare costs and more impairment in work and activities of daily living (p < 0.01 for all analyses). Avoidance of alcohol, lower educational level, abnormal anxiety, depression or somatoform symptom-reporting scores, and impairment in social leisure activities, home management or maintaining close relationships were all independently associated with lower quality of life.

IBS has a substantial impact on the quality of life of those affected, and worse than observed in some severe chronic organic conditions.