Hypofractionation (HF) has been established as safe in prostate cancer (PCa) trial populations. We evaluated post-treatment changes in health-related quality of life (HRQoL) outcomes after moderate (MHF) or ultra-hypofractionated (UHF) radiotherapy in a real-world PCa patient population.

In this prospective cohort study, T1-4N0M0 PCa patients receiving MHF (20x3/3.1 Gy, n = 140) or UHF (7x6.1 Gy, n = 138) were assessed. UHF was not prescribed in case of T3b/T4 disease or an impaired baseline urinary function. Patients completed the EPIC urinary and bowel domains and the EQ-5D-5L (general HRQoL) at baseline and 6 months post-treatment. Thresholds for minimal clinically important differences (MCID) were defined at 8 %. Prognostic factors were assessed using regression models.

Proportion of the total cohort with MCID deterioration for bowel and urinary function was 20 % and 17 %, respectively. Deteriorations in bladder and bowel function significantly correlated with declined scores for general health, usual activities, pain/discomfort, and depression/anxiety. Predictive factors for urinary function deterioration at multivariable analysis were androgen deprivation therapy, age ≥ 75 year, MHF, and grade ≥ 2 acute urinary toxicity. For bowel function deterioration, no factors were identified.

We assessed post-treatment changes in HRQoL in a clinical PCa patient population treated with MHF and UHF, and observed changes comparable to previous trial reports. Deteriorations in bowel and urinary function correlated with worse general health scores. Results for urinary function loss suggested a consequential effect of acute urinary toxicity.

The utilities elicited with the composite time trade-off (cTTO) method for health states worse-than-dead (WTD) often correlate poorly with other severity measures, indicating a poor sensitivity of cTTO. We aimed to explore modifications to cTTO to better understand this phenomenon and identify potential improvements.

A total of 480 respondents completed an online TTO interview, each valuing 12 EQ-5D-5L health states. The participants were randomized into four arms, A-D. Arm A followed the standard cTTO, serving as a reference. In arm B, we removed the sorting question comparing immediate death versus 10 years in a valued state. Arm C allowed for utility values < - 1 by reducing the time in the valued state in the lead-time TTO (LT-TTO) part of cTTO. In arm D, we randomly selected the starting negative utility in LT-TTO. Utility value distributions, correlations between utilities and level sum score (LSS), and inconsistencies between Pareto-ordered states were analyzed.

Arm A replicated the lack of significant correlation between LSS and the negative utility observed in previous work. Of the experimental arms, only arm B exhibited a significant negative correlation. Compared with arm A, arm B produced a higher proportion of WTD states ( 46.5 % versus  26.3 % ), less negative utility for WTD states on average ( - 0.571 versus  - 0.752 ), and a lower mean censored utility for 55555 ( - 0.486 versus  - 0.406 ).

The observed lack of correlation between LSS and utility for WTD states appears linked to the use of comparison with immediate death in the sorting question. LT-TTO is capable of eliciting utility values in a way that is sensitive to severity. Modifying the initial questions in cTTO to identify whether health states are BTD or WTD should be considered.

There is a growing interest in Health Technology Assessment (HTA) in Morocco. A national EQ-5D-5L value set would allow for the computation of Quality Adjusted Life Years (QALYs) in economic evaluations of healthcare interventions to support decision-making. This study aimed to develop a Moroccan EQ-5D-5L value set based on data from a representative sample of the Moroccan adult general population.

A Moroccan representative sample of adults was recruited using stratified quota sampling based on gender, age category, and place of residence. Data were collected between November 2022 and December 2023 using the international EuroQol valuation protocol, EQ-VT version 2.6.1. This protocol includes two elicitation techniques: the composite time trade-off (cTTO) and the discrete choice experiment (DCE). cTTO and DCE data were modeled using a heteroskedastic Tobit model and a conditional logit model, respectively. In addition, these models were combined using a hybrid model.

A total of 976 respondents were included in the final analysis. The hybrid heteroskedastic model was considered the preferred model. The predicted utility values ranged from -1.492 for the worst health state (55555) to 1 for full health (11111), where the two mildest impaired states (11211 and 21111) had a utility value of 0.979. Pain/discomfort had the largest effect on health utility values, followed by anxiety/depression, mobility, self-care and usual activities.

Morocco is the third country in the Middle East and North Africa (MENA) region with an EQ-5D-5L value set. This study supports the use of EQ-5D-5L data for healthcare decision-making in the Moroccan context.

A substantial untapped potential for risk reduction may be fulfilled by applying intensive lifestyle interventions targeting the co-existing risky lifestyle factors Smoking, Nutrition (both malnutrition and obesity), risky Alcohol intake, and Physical inactivity (SNAP) before surgery. This trial will compare the effect of combined and individually tailored prehabilitation with standard care on postoperative outcomes, health, and cost-effectiveness in short and long term in participants undergoing ventral hernia repair. An interview study will be nested within the randomised trial.

The study is a multicenter, parallel-group, superiority randomised clinical trial. A total of 400 adult participants undergoing ventral hernia repair with ≥1 SNAP factor will be allocated to the individually tailored STRONG programme or standard care. The STRONG programme is initiated at least four weeks prior to surgery and consists of six sessions. It is delivered as one session a week, approximately, and includes patient education, motivational, and pharmaceutical supports. The primary outcome is postoperative complications requiring treatment within 30 days. Secondary outcomes address other surgical outcomes, changes in lifestyle, health, and cost-effectiveness. Follow-up takes place after 6 weeks (the end of intervention), at surgery, and 30 days, 90 days, and 6 months after surgery, respectively. Long-term data on health and costs will be obtained from nationwide registries after two years. Eligible trial participants will be invited to a semi-structured interview study at baseline. Their reflections on the STRONG programme and the choice of participating in the trial or not will be explored.

Many patients have multiple SNAP factors adding to the risk of complications related to surgery. As these are modifiable, prehabilitation may be an area with great potential for risk reduction. Nevertheless, no well-acknowledged and evidence-based strategies exist in the preoperative period. The STRONG programme is tailored specifically to the individual patient's preidentified needs including up to all five common risky SNAP factors and may tap into the large unused potential for risk reduction. Overall, the study will add important new knowledge on the effect of individually tailored prehabilitation on complications and other important outcomes in elective surgery, and also clarify if this intervention will have long-lasting implications.

www.clinicaltrials.gov (NCT06611462).

Online elicitation of Personal Utility Functions (OPUF) is an innovative approach to valuing health states. OPUF uses a combination of ranking, swing-weighting, levels-rating and anchoring dead tasks. Little is known about how participants interpret and engage with OPUF tasks. This study aimed to address this gap.

Cognitive debrief interviews, which included 'think-aloud' and probing questions, were undertaken in the UK to understand how members of the public engage with OPUF when used to value the EQ-HWB-S (EQ Health and Wellbeing Short version). Coding drew upon a Framework approach, with final codes including an assessment of how participants engaged with each of the five OPUF tasks based on whether (1) they completed as expected, (2) minor concerns were identified or (3) major concerns were identified. The presence of major concerns was judged to undermine the validity of responses.

All 27 interviews were identified to have at least minor concern and 18 (67%) were identified as having major concerns. Major concerns were identified in four of the tasks: ranking (in 19% of interviews), swing-weighting (30%), levels-rating (56%), anchoring dead task (48%). Older participants were more likely to have major errors.

Think-aloud and probing interviews with 27 participants completing the OPUF identified multiple concerns, to the extent that their data is unlikely to be a valid reflection of their preferences. The extent of concerns identified here suggests the need for interviewer led data collection within OPUF to ensure data quality.

US stakeholders advised including adolescents in the valuation study for the EQ-5D-Y-3L, a step toward greater acknowledgment of children in informing societal values. This study aimed to assess the relative contribution of adolescent and adult preferences to a model when combined.

Discrete choice experiment data were collected from an online sample of 1529 adults and 714 adolescents (ages 11-17). Each respondent completed 15 discrete choice experiment tasks, which were analyzed using latent class models representing varying number of preference classes. Within the best-fitting model, the contribution of each class was determined by the scale-adjusted class share (SACS), combining the class's proportion of respondents (class share) and the magnitude of coefficients (within-class scale). We estimated the contribution of adolescent and adult respondents to SACS for each class, with lower SACS representing less contribution to the combined model.

The best-fitting model described 6 classes. Adults had higher contribution to all except 1 class, accounting for 78.7% of the total contribution. After adjusting for the unequal sample size of adolescent and adult respondents, adults contributed approximately 65.0%, and adolescents contributed 35.0% of the weights toward a combined model.

Adolescents showed diminished, disproportionate representation in a combined model, due in part to more indifferent, less informative preferences for EQ-5D-Y-3L health states compared with adults. Latent class analysis showcases one approach to estimate and weight contributions from intentionally sampled subgroups in a combined model.

ObjectivesDiscrete choice experiments (DCEs) as a valuation method require preferences to be anchored on the quality-adjusted life-year scale, usually through tasks involving choices between immediate death and various impaired health states or between health states with varying durations of life. We sought to determine which anchoring approach aligns best with the composite time tradeoff (cTTO) method, with a view to informing a valuation protocol that uses DCEs in place of the cTTO.MethodsA total of 970 respondents from Trinidad and Tobago completed a DCE with duration survey. Tasks involved choosing between 2 lives with identical durations, followed by a third option, representing either full health for a number of years or immediate death. Data were analyzed using mixed logit models, both with and without exponential discounting for time preferences.ResultsAssuming linear time preferences, the estimated utility of immediate death was -2.1 (95% credible interval [CrI] -3.2 to -1.2) versus -0.28 (95% CrI -0.47, -0.10) when allowing for nonlinear time preferences. Under linear time preferences, the predicted health-state values anchored on duration had range (-1.03, 1) versus (0.34, 1) when anchored on immediate death. The ranges under nonlinear time preferences were (-0.54, 1) versus (-0.22, 1). The estimated discount parameter was 23% (95% CrI 22% to 25%).ConclusionsThe nonzero discount parameter indicates that time preferences were nonlinear. Nonlinear time preferences anchored on duration provided the closest match to the benchmark EQ-VT cTTO values in Trinidad and Tobago, whose range was (-0.6, 1). Thus, DCE with duration can provide similar values to cTTO provided that nonlinear time preferences are accounted for and anchoring is based on duration.HighlightsTime preferences for health states in Trinidad and Tobago were nonlinear.In discrete choice tasks, we show that immediate death has a utility less than zero.DCE utilities under nonlinear time preferences with anchoring on duration agreed well with cTTO utilities.

Many people with stroke experience incomplete recoveries, leaving them with upper extremity (UE) deficits affecting their long-term independence. Interventions including virtual reality (VR) and robotics have been developed to foster neuroplasticity post stroke. Few of the many studies examining these interventions consider the impact of both timing and dosage. The primary aim of this randomized controlled trial was to investigate (1) dosage and (2) timing of UE VR/robotic training in the subacute period post stroke. 100 participants were consented 5-30 days after stroke. They were randomized to an Early (first month) or Delayed (second month) VR/robotic group (EVR/DVR), a dose matched usual care group (DMUC) or a usual care group (UC). Participants were evaluated using impairment, motor function, and quality of life measures immediately before, after, and 1 month after training, and 4 and 6 months post stroke. At 4 months post stroke the DVR group showed a higher rate of change from baseline on the Action Research Arm Test compared to the EVR group. This difference was not sustained; none of the training groups demonstrated significantly better scores on any outcome measure 6 months post stroke. Growth mixture modeling revealed three groups with patterns of recovery associated with early finger movement. At 6 months post stroke, the EuroQol was moderately correlated with impairment and activity.

BackgroundThe evaluation and intervention process of musculoskeletal disorders necessitates the assessment of functional disabilities. An Arabic version of the short musculoskeletal function assessment questionnaire (SMFA) is unavailable and necessary to be delivered.ObjectiveTo cross-culturally adapt the SMFA into the Arabic language (SMFA-AR) and then to examine its measurement properties.MethodsFour hundred and forty-six patients with a mean age of 40.99 ± 11.74 were recruited through direct referrals. The translation process was performed using published guidelines. Patients were asked to fill out the SMFA-AR twice within a 2-7-day interval for the reliability assessment which was calculated using Intraclass Correlation Coefficient (ICC) for test-retest and by using Cronbach's alpha for internal consistency. Construct and concurrent validity were tested by calculating the Pearson's correlation coefficient between the SMFA-AR, the Arabic version of the quick Disability of the Arm, Shoulder, and Hand (Quick DASH-AR), the Arabic Lower Extremity Functional Scale (LEFS- Arabic), the Arabic version of the European quality of life questionnaire (EQ-5D- AR), and the Arabic numeric pain rating scale (NPRS-AR).ResultsThe SMFA-AR showed excellent test-retest reliability (ICC = .988) and excellent internal consistency (Cronbach's alpha = 0.89). The standard error of measurement (SEM) and the minimal detectable change (MDC95) values were 1.419 and 3.933 respectively. On the other hand, the SMFA-AR showed a weak to moderate construct and concurrent validity with the quick DASH-AR, LEFS-AR, EQ-5D-AR, and NPRS-AR (r = 0.56, -0.24, -0.58, 0.31 respectively). There was no floor or ceiling effect for the SMFA-Ar. All the reported P values were less than 0.01ConclusionRegarding test-retest reliability and internal consistency, an excellent result was reported by the newly adapted SMFA-AR. Additionally, a weak to moderate construct and concurrent validity was found. It is advised to use the newly adapted SMFA-AR with Arabic-speaking patients having different musculoskeletal dysfunctions.

Integrated care services have been initiated in China for several years, yet there remains a dearth of substantial evidence and research elucidating the service's efficacy, particularly in underdeveloped areas. This study aims to address this gap by evaluating the effectiveness of integrated care from the patients' perspective, thereby offering practical strategies to improve service effectiveness and promote health equity within county medical alliances.

The Patient Perceptions of Integrated Care (PPIC) and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5 L) scales were employed to gather information on patients' perceptions of integrated care and their self-rated health status. A total of 1093 respondents from two pilot areas were selected for data collection. T-tests and one-way analysis of variance (ANOVA) were recruited, additionally, the study utilized multiple linear regression models to examine the specific impact of various factors on the effectiveness of integrated care services.

The average score for the effectiveness of integrated healthcare services from the patients' perspective was 67.72 (SD = 14.443, n = 1093). Statistical analysis revealed that as the respondents' age increased and their self-rated health declined, the PPIC scores showed an upward trend. Regression analysis found that factors such as age, education level, income, health status, and level of healthcare intervention significantly influenced PPIC scores. Overall, there is a trend where respondents with higher health needs tend to have higher perceptions of the service, while those with relatively higher socioeconomic status are more likely to provide lower ratings. Additionally, increasing the frequency and duration of healthcare interventions can improve respondents' evaluations of the services.

This study analyzes the effectiveness of integrated services in China's county-level medical alliance from the patients' perspective. It finds progress in resource integration and efficiency but identifies limitations in implementation, particularly in balancing equity. Socio-economic factors continue to affect the fairness of service utilization and patient satisfaction. Constraints in finance, human capital, and technology hinder the provision of more targeted services for vulnerable groups. To promote health equity, future services need to focus more on key populations and provide more targeted services, accelerate the integration of information technology, and expand service coverage to address the diverse needs of marginalized communities.

Earlier work has shown that adults valuing health for 10-year-old children (i.e., in a child perspective) are more reluctant to trade-off life duration than for themselves, generating higher utilities in composite time trade-off (cTTO). The main motivation of this study is to explore if this reluctance can be explained through loss aversion, i.e., losses of life duration weighing more than gains of the same size.

100 UK adults completed cTTO tasks for six EQ-5D-Y-3L states and tasks measuring loss aversion. Both sets of tasks were completed from the child perspective and for the respondent themselves, enabling perspective-dependent correction for loss aversion.

A slight majority of participants was explicitly more loss averse for children than for themselves. Health state utilities were higher in the child perspective both before and after correction for loss aversion. Differences between utilities elicited in both perspectives and the variance of cTTO utilities increased considerably after correction.

The results suggest that loss aversion does not explain differences in willingness to trade-off life duration between perspectives. Hence, it remains unclear if correction for loss aversion should be recommended when using EQ-5D-Y-3L utilities in practice.

Indolent lymphomas are generally incurable, with protracted disease courses. The approval of drug treatment options often relies on surrogate endpoints (eg, progression-free survival), which do not capture patient-centred outcomes such as quality of life (QOL). This systematic review characterises the use of QOL as an endpoint in randomised controlled trials (RCTs) of indolent lymphomas, and the association of QOL with survival outcomes. ClinicalTrials.gov was searched from database inception to May 20, 2024, for phase 3 RCTs of indolent lymphomas, including follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia or small lymphocytic lymphoma, gastric mucosa-associated lymphoid tissue lymphoma, and Waldenström macroglobulinaemia. 103 RCTs met eligibility criteria. Data on QOL endpoints were collected in 53 (51%) of 103 trials, but reported in only 25 (24%). Improvements in QOL was reported in 11 (44%) of these RCTs, and these trials were more likely to show progression-free survival and overall survival benefits. We found that trials with neutral or worsened QOL outcomes often framed the results positively, presenting QOL data as supporting treatment use. This systematic review highlights that data on QOL endpoints are undercollected, under-reported, and often positively framed despite a lack of improvement, underscoring the need for transparent QOL reporting to enhance patient-centred care.

In Jordan, no national value set is available for any preference-accompanied health utility measure.

This study aims to develop a value set for EQ-5D-3L based on the preferences of the Jordanian general population.

A representative sample of the Jordanian general population was obtained through quota sampling involving age, gender, and region. Participants aged above 18 years were interviewed via videoconferencing using the EuroQol Valuation Technology 2.1 protocol. Participants completed ten composite time trade-offs (cTTO) and ten discrete choice experiments (DCE) tasks. cTTO and DCE data were analyzed using linear and logistic regression models, respectively, and hybrid models were applied to the combined DCE and cTTO data.

A total of 301 participants with complete data were included in the analysis. The sample was representative of the general population regarding region, age, and gender. All model types applied, that is, random intercept model, random intercept Tobit, linear model with correction for heteroskedasticity, Tobit with correction for heteroskedasticity, and all hybrid models, were statistically significant. They showed logical consistency in terms of higher utility decrements with more severe levels. The hybrid model corrected for heteroskedasticity was selected to construct the Jordanian EQ-5D-3L value set as it showed the best fit and lowest mean absolute error. The predicted value for the most severe health state (33333) was - 0.563. Utility decrements due to mobility had the largest weight, followed by anxiety/depression, while usual activities had the smallest weight.

This study provides the first EQ-5D-3L value set in the Middle East. The Jordanian EQ-5D-3L value set can now be used in health technology assessments for health policy planning by the Jordanian health sector's decision-makers.

The Weight-Specific Adolescent Instrument for Economic Evaluation (WAItE) is a weight-specific patient-reported outcome measure for use in adolescence, consisting of 7 domains, each with 5 response levels. The objective of this study was to generate a UK value set for the WAItE, enabling the calculation of utility values.

An online discrete choice experiment (DCE) completed by an adult sample representative of the working population of the United Kingdom was used to estimate the preferences for the 5 levels of the 7 domains. DCE data were analyzed using multinomial and mixed logit models. The latent values were then anchored onto the 0-1 death-full health quality-adjusted life year scale using 2 different anchoring techniques, the time trade-off method and the DCE-visual analog scale method.

A total of 1004 adults from the United Kingdom were included in the final estimation sample for the DCE. From the latent estimates, the majority of the levels of the dimensions followed the monotonic nature of the WAItE; however, some levels of the Tiredness-, Walking-, and Sports-related dimensions were not monotonic and combined to generate the final value set. The results from the time trade-off and DCE-visual analog scale anchoring methods were similar, with values for the PITS state (the worst health state possible from the WAItE) of 0.289 and 0.230.

This study has developed a value set for the WAItE based on the preferences of the UK population, enabling the use of the WAItE in cost-utility analyses of interventions targeting obesity in adolescents.

This study aimed to develop a value set for the EQ-5D-5L based on preferences of the general adult population of the United Arab Emirates (UAE).

The study followed the EuroQol EQ-5D-5L valuation protocol and involved conducting interviewer-administered face-to-face or online interviews in Arabic or English, using the EuroQol Valuation Technology with a sample of 1005 adults representing the UAE general population. Sample recruitment involved a 2-stage quota sampling strategy across the 7 emirates of the UAE, ensuring representation of nationals and expatriates. Various models using composite time trade-off data only, discrete choice experiment data only, and hybrid using both composite time trade-off and discrete choice experiment data were examined, along with various sensitivity analyses to examine the robustness of the models.

The average age of respondents was 39 years (SD 10.8), 44.5% were female, and 11% were UAE nationals. The best-performing model to generate the value set for the EQ-5D-5L was the hybrid tobit model censored at -1.0, corrected for heteroskedasticity. Values ranged from -0.654 for the worst health state (55555) to 1 for full health (11111) and 0.962 for 11211, with 15.3% of predicted values worse than dead. Mobility problems had the largest impact on health state preference values relative to other dimensions.

This value set will facilitate the application and use of the EQ-5D-5L instrument in the UAE population in generating local evidence on the cost-effectiveness of healthcare interventions, as well as to enhance other applications of EQ-5D in population health assessment and health systems.

Limited knowledge exists regarding individuals' thought processes when valuing health states using composite time trade-off (cTTO) tasks, particularly for health states considered worse than dead (WTD). This study aimed to explore the reasons for WTD perception, the strategies respondents used to value WTD states, and the challenges they faced during cTTO tasks.

This qualitative investigation was embedded within a methodological EQ-5D-5L valuation study involving the general public in Singapore, where respondents completed 7 cTTO and 7 novel TTO tasks. Semistructured interviews were conducted with respondents who assigned WTD values to 1 or more health states in the cTTO tasks. Interviews were recorded, transcribed verbatim, and analyzed using framework analysis.

Nineteen respondents were interviewed (age range: 21-71 years old). Respondents identified a range of interconnected factors leading to WTD valuation, including health state and its duration, personal beliefs and circumstances, and consequences of poor health. Although respondents usually considered these factors thoroughly and were capable of complex trading-off between life years and health, some respondents resorted to heuristic strategies to simplify the valuation process, including attribute nonattendance, affect heuristic, and elimination-by-aspects strategies. Respondents encountered various difficulties when they completed the cTTO tasks, including identifying the indifference point, transitioning from conventional TTO to lead-time TTO, and interpreting and imagining health states.

This study investigated how individuals value WTD health states in cTTO tasks. It suggested that cTTO needs improvement and provided insights into how to improve the design of valuation tasks for severe health states.

The objective of this study is to evaluate the feasibility and safety of renal artery embolization (RAE) via transradial access (TRA) in patients with renal angiomyolipoma (AML) or renal hemorrhage.

Data were collected for this prospective single-center study from 50 patients (51 ± 12 years; male:female, 11:39) who underwent RAE for renal AML (n = 46) or renal hemorrhage (n = 4) between November 2020 and January 2024. Patients with a Barbeau D waveform or a radial artery diameter of <1.5 mm were excluded. Technical success in patients with renal AML and renal hemorrhage was defined as achieving selective catheterization of the culprit artery with embolization, leading to flow stasis and the absence of bleeding evidence, respectively. Clinical success was indicated by a reduction in AML size on follow-up CT scans and the absence of bleeding signs without necessitating additional RAE. The EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire was utilized to assess health-related quality of life (HRQoL).

In one patient with AML, embolization could not be performed following selective catheterization and angiography due to the lack of visible tumor vascularity, resulting in a technical success rate of 98% (49/50). The clinical success rate was 96% (48/50 patients). No instances of TRA failure, conversion to transfemoral access (TFA), or hemostasis failure were noted. During the follow-up period, no major adverse events associated with the RAE occurred. Two patients exhibited asymptomatic radial artery occlusion, and one patient displayed asymptomatic partial thrombosis of the renal artery at the first follow-up visit. The EQ-5D-5L scores were 0.90 (95% confidence interval [CI]: 0.86-0.95) within 24 hours post-procedure and 0.89 (95% CI: 0.85-0.92) at the first follow-up (P = 0.332).

TRA is a feasible and safe approach for performing RAE in patients with renal AML or hemorrhage. RAE performed using TRA demonstrated high HRQoL outcomes and may serve as a viable alternative to TFA for performing RAE.

In many countries, methods of economic evaluation and Health Technology Assessment are used to inform healthcare resource allocation decisions. These approaches often require EQ-5D health outcomes measures. This study aimed to create an EQ-5D-3L value set for Bermuda from which EQ-5D-5L Crosswalk values could be obtained.

Respondents in Bermuda were recruited locally. A team of Trinidad-based interviewers with prior EQ-5D-3L valuation experience conducted valuation interviews on-line using the EQ-VT protocol. Respondents completed composite time-trade off (cTTO) and discrete choice experiment (DCE) tasks. A hybrid model that included both the cTTO and DCE data was estimated. An EQ-5D-5L crosswalk value set was then created from the EQ-5D-3L index values. Coefficients in the resulting crosswalk model were compared with those of crosswalk and valuation studies from other countries.

The valuation tasks were completed by a near-representative sample of 366 adult Bermuda citizens. Half of the respondents reported being in state 11111. The lowest EQ VAS and EQ-5D-3L index values were 20 and - 0.120 respectively. The hybrid model produced all logically consistent and statistically significant coefficients that in turn produced index values that were very similar to those obtained in a preliminary model (MAD of 0.027).

The on-line EQ-VT valuation study was successfully conducted in Bermuda and the values therein can now be used for economic analysis in Bermuda. The Bermuda values differed considerably from those of the other countries against which they were compared. Challenges were encountered with recruitment for an on-line survey in a small population.

The aims of this study were to provide population norms for EQ-5D-5L in Hungary and investigate the differences in EQ-5D-5L normative data by survey mode, i.e. online surveys and computer assisted personal interviews (CAPI).

A pooled database was built comprising six online (N = 7,034) and two CAPI (N = 3,020) population-based studies with the EQ-5D-5L. Descriptive statistics were performed. Multinominal logistic and linear regression analyses were applied to compare the online and CAPI samples. Traditional and machine learning regression tools were used to investigate the determinants of EQ-5D-5L index values.

'No problems' in any of the five EQ-5D-5L domains were reported by 33.9% (online) and 58.9% (CAPI) of the participants. Most problems were reported on the pain/discomfort domain in both study types (51.9% and 33.6%, respectively). Men and more educated respondents had significantly higher average EQ-5D-5L index values. EQ-5D-5L index values and EQ VAS scores were significantly higher in the CAPI sample, except in age groups 65-74 (no difference) and 75+ (online scores were significantly higher). Only 7-10% of variance in the EQ-5D-5L index values was explained by the variables survey mode, education, sex and age, with age having the largest and sex the smallest effect.

EQ-5D-5L population norms derived from online and CAPI studies may differ significantly from each other. It is recommended to consider the survey mode, sampling and sociodemographic characteristics of the participants when choosing population norms as reference set. Further comparative studies investigating EQ-5D-5L population norms by different study designs and administration modes are encouraged.

We conducted a systematic literature review to summarize the application of statistical methods for analyzing treatment effect on EQ-5D in randomized clinical trials (RCTs).

We searched 2 electronic databases (MEDLINE and EMBASE, from inception through 2021) and www.

gov. Eligible studies were RCTs that analyzed postbaseline EQ-5D data by treatment group. Information on trial characteristics, EQ-5D data characteristics, and statistical methods were extracted. Descriptive statistics were used to summarize results by dimension response, EQ visual analog scale (EQ VAS), and EQ-5D utility.

A total of 2125 trials met the eligibility criteria. EQ-5D was commonly considered a secondary (n = 1219, 57.4%) or exploratory (n = 775, 36.5%) endpoint in RCTs. EQ-5D utilities were the most analyzed. Both utilities and EQ VAS were primarily analyzed in numerical format. The most common statistical models for analyzing utilities were the linear fixed-effect model for single postbaseline (192/589, 32.6%) and the linear mixed-effect model for multiple post-baselines (338/984, 34.3%). Of the 2054 studies that analyzed numerical EQ-5D, 221 (10.8%) examined model assumptions and 438 (21.3%) adjusted for the baseline score. Missing data were explicitly assessed in 661 trials, among which 347 (52.5% of 661) applied imputations, with the 2 most used imputation methods being multiple imputations (n = 200, 57.6% of 347) and last observation carried forward (n = 106, 30.5% of 347).

This review found that health utilities are the most frequently analyzed EQ-5D data collected in clinical trials, followed by EQ VAS. Significant variation was observed in the selection of models, with most trials lacking adjustments for baseline data and appropriate methods for handling missing data.

Cardiac rehabilitation is known to reduce morbidity and improve quality of life in people living with heart disease, however, adherence, access and completion of these programmes is suboptimal. Peer support may offer an opportunity to close this service gap. The aim of the study is to determine whether the effectiveness of a digital peer support programme for people living with heart disease is effective in improving social connectedness, clinical and patient-reported outcomes and experience measures.

Heart2Heart is a community-based randomised controlled trial with 6 months follow-up for the primary outcome and 6 and 12 months for secondary outcomes. Approximately 752 adults with a diagnosis of heart disease in the past 12 months will be recruited from the general community and Australian cardiac rehabilitation programmes. Control group will participate in usual care, while intervention group will have access to a 6 months intervention that enables peer support via an interactive mobile application, in addition to usual care. The intervention includes online discussion groups, access to resources and facilitated conversations with health professionals. Primary outcome is social connectedness at 6 months follow-up. Secondary outcomes (6 and 12 months) will be all-cause/cardiovascular disease hospital admissions, all-cause mortality, lifestyle (sufficiently physically active, not smoking, sufficient fruit and vegetable consumption), proportion taking prescribed medications and health service utilisation (medical appointments, cardiac rehabilitation, participation in any other in-person peer support activities). Patient-reported outcome and experience measures including self-efficacy, quality of life, satisfaction and programme engagement will be analysed at 6 months. Process measures will include application analytics, barriers and facilitators to engagement with the intervention from participant's perspective. An intention-to-treat analysis will be used.

Ethical clearance was obtained from Western Sydney Local Health District Ethics Committee. Heart2Heart has potential to improve social connectedness and provide a valuable addition to traditional cardiac rehabilitation.

ACTRN12624000386538.

The Gambling Quality of Life Scale -brief (GQoLS-Brief) assesses the impact of gambling disorder (GD) on quality of life (QoL). Preference-based measures are essential for obtaining the quality adjustment weight (i.e. utility score) needed to calculate quality-adjusted life years (QALYs) in economic evaluations. We aimed to derive a value set for the GQoLS-Brief.

We employed a discrete choice experiment for preference elicitation. An online survey was administered (n = 928). Respondents completed 10 choice tasks, each presenting two GQoLS-Brief health states alongside life expectancy. Conditional logit regression, parameterized to fit the QALY framework, was used for data analysis. QALY weights for each health state defined by the GQoLS-Brief were calculated.

The estimated coefficients from the conditional logit models aligned with expectations: utility increased with survival time and decreased with QoL impairment. Utility values for health states ranged from - 1.48 (worse than death) to 1.0. "Financial difficulties" exhibited the highest utility decrement, followed by "Sleep disturbance related to financial difficulties."

This reference set facilitates the calculation of QALYs for economic evaluations of GD interventions. The weight of subjective financial difficulties underscores the need for therapeutic interventions to target this aspect.

We conducted a cluster-randomized-controlled trial (cRCT) in 18 German nursing homes (NH) to evaluate the cost-effectiveness of reinstruction and remotivation of nursing staff by dental assistants (DAs) over 13 months.

In the intervention arm, dentists examined NH residents, identified oral health conditions, and prescribed individualized oral care interventions. Nursing staff delivered these interventions, with regular follow-up support from DAs (reinstruction and remotivation). In the control group, similar interventions were prescribed via a standardized form, without reinstruction and remotivation (standard of care). The primary outcome was Oral-Health-related Quality-of-Life (OHrQoL) using the Geriatric/General Oral Health Assessment Index (ADD-GOHAI). Secondary outcomes included Health-related Quality-of-Life (HrQoL) using the EQ-5D summary index and caries experience (DMFT index). Costs, including those for staff, materials, and travel, were assessed in Euro 2022. Cost-effectiveness ratios and bootstrapping simulations assessed cost-effectiveness-acceptability at different willingness-to-pay thresholds.

Of 358 recruited participants, 68 and 63 in the intervention and control group completed the study. No significant differences existed between groups in demographics or baseline health measures. After 13 months, changes in ADD-GOHAI and DMFT scores were minimal and non-significant, while EQ-5D scores decreased in the intervention group (p < 0.001). Total costs were higher in the intervention arm (median 121.10 Euro) versus the control (median 0 Euro, p < 0.001), mainly due to travel expenses. The intervention increased dental service use but demonstrated lower cost-effectiveness acceptability.

DA-led reinstruction did not improve OHrQoL, negatively impacted HrQoL, and increased costs. Notably, our study was suffering from significant attrition, impacting on statistical power.

Reinstruction and remotivation by dental assistants did not improve OHrQoL, but generated significant costs, mainly due to an uptake of dental services.

ClinicalTrials.gov (Trial registration number NCT04140929).

To develop the Norwegian value set for the EQ-5D-5L based on interviews with a representative sample of the Norwegian adult population.

Random and quota sampling were used to recruit the sample of adults (age> 18 years) representative of the Norwegian general population. Data collection followed EQ-VT 2.1 undertaken before and after the COVID-19 pandemic from November 2019 to December 2022, using PC-assisted and video conferencing interviews, respectively. Each respondent valued 10 health states using composite time trade-off (cTTO) and 7 health states using a discrete choice experiment (DCE). Different statistical models were assessed for logical consistency and predictive accuracy using cTTO and DCE data alone or in combination as hybrid models.

Of the 1,321 respondents, 1,237 met inclusion criteria. All statistical models demonstrated logical consistency. The weighted hybrid model combining both cTTOand DCE data was preferred and had the highest predictive accuracy. Predicted values ranged from -0.453 to 1, and the dimension of anxiety/depression was the most highly valued by respondents, followed by pain/discomfort, self-care, mobility, and usual activities. These findings are not dissimilar to those for most Western European countries, and regression coefficients are closest to those for other Scandinavian countries.

This study provides the Norwegian value set for the EQ-5D-5L based on health state values obtained from members of the adult general population in Norway. This is an important contribution to economic evaluation and the broader application ofthe EQ-5D-5L in Norway including clinical and health services research, and quality measurement.

Comprehensive clinical data regarding factors influencing the individual disease course of patients with movement disorders treated with deep brain stimulation might help to better understand disease progression and to develop individualized treatment approaches.

The clinical core data set was developed by a multidisciplinary working group within the German transregional collaborative research network ReTune. The development followed standardized methodology comprising review of available evidence, a consensus process and performance of the first phase of the study. To ensure high data quality, measures for standardized training, monitoring as well as plausibility and data quality tests were implemented.

The clinical core data set comprises information about medical history, clinical symptoms, information about deep brain stimulation surgery, complications and outcome for the main neurological movement disorders Parkinson's disease, tremor, and dystonia. Its applicability as well as data exchange and quality control was tested within the first phase of the study in 51 patients from Würzburg.

Within the ReTune project, a standardised clinical core data set for Parkinson's disease, dystonia and tremor was developed. The collection as well as concepts for the implementation of monitoring and data exchange were elaborated and successfully tested. Trial registration number ClinicalTrials.gov (DRKS-ID: DRKS00031878).

The limitations of pharmacological treatments for chronic pain have become increasingly evident: dependency, side effects, resistance, and diminishing efficacy. The urgent need for innovative solutions has become a compelling focus for improving patient outcomes. Innovative non-pharmacological approaches, such as sleep management, as a strategy to reduce opioid consumption and pain control are needed. The aim was to evaluate the impact of a Sleep and Circadian Intervention Program (SCIP) in the control of chronic musculoskeletal pain (CMP). This was a randomized clinical trial (NCT03646084), in which 49 CMP patients were assigned to SCIP (n = 15, mean age 51 years and 40% women) or non-SCIP groups (n = 26, 53 years and 61.5% women). Outcomes were evaluated after 6 months through self-reported questionnaires (pain intensity, physical function, depression/anxiety, and quality of life (QoL)). The SCIP group was assessed by polysomnography and specific questionnaires and was treated for diagnosed sleep disorders according to clinical guidelines. This population showed a moderate pain intensity at baseline, important deterioration of QoL and pathological anxiety/fear related to pain. Fifty percent of them presented restless leg syndrome, 60% moderate/severe insomnia, and 62.5% sleep apnea. During the follow-up, the SCIP group presented a greater reduction in the abnormal risk group for anxiety (from 73.3% to 46.7%) and depression (from 53.3% to 33.3%) on the Hospital Anxiety and Depression Scale compared to the non-SCIP group (from 40% to 29.2% and 33.3% to 29.2%, respectively). Also, a positive significant effect on anxiety/fear related to pain was found in the Pain Anxiety Symptoms Scale multivariable model, with an important improvement in symptoms. The application of SCIP in CMP patients improved anxiety and controlled associated sleep disorders, highlighting the impact on insomnia. Larger studies are needed for better understanding of the sleep intervention in CMP control.

Chronic kidney disease (CKD) is a major public health concern, and early detection is crucial to prevent adverse outcomes. Albuminuria is an early marker and key prognostic marker in CKD, but reliable tools for its detection are limited particularly in low resource settings. We tested the utility of a novel, affordable point-of-care test (POCT) for albuminuria among high-risk individuals for CKD.

This is a community-based cross-sectional study covering 17 primary subdistrict healthcare units in Ban Phaeo District, Samut Sakhon Province, Thailand. The inclusion criteria were asymptomatic adult participants diagnosed with hypertension, diabetes and/or aged over 60 years. We measured serum creatinine and quantitative urine albumin-creatinine ratio (UACR) and administered POCT urine albumin strip test (Albii, K. BioSciences, Bangkok, Thailand) and urine dipstick test for protein. Participants with albuminuria or estimated glomerular filtration rate (eGFR) by CKD-EPI 2009 equation <60 mL/min/1.73 m2 were considered to have suspected CKD. We evaluated diagnostic performance of POCT urine albumin strip.

Among 2307 participants, 489 (20.3%) participants had reduced eGFR and/or albuminuria. The median eGFR was 93.23 (87.82, 98.73) mL/min/m2, and the median UACR was 9.15 (5.09, 20.96) mg/g. The POCT urine albumin strip showed a sensitivity of 0.70, specificity of 0.97 and accuracy of 0.92 compared with the quantitative UACR. Conversely, the POCT urine dipstick for protein had poor sensitivity, positive predictive value and accuracy.

The urine albumin test strip is a highly effective tool to conduct point-of-care identification for early CKD among high-risk populations. Given the test's diagnostic performance and ease of use, such test should be incorporated into health policy.

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. This includes the development of an updated version, SF-6D version 2 (SF-6Dv2), which was generated to deal with some criticisms of the first version, and now includes a standalone version for inclusion in studies without relying on use of SF-36 or SF-12. Valuation methods have also evolved, from standard gamble in-person interviews to online discrete choice experiment surveys. International work related to the SF-6Dv1 and SF-6Dv2 is considered. We also consider recommendations for use, highlighting key psychometric evidence and reimbursement agency recommendations.

Surgical stabilization of rib fractures (SSRF) is a viable treatment option for rib fracture patients. Polyetheretherketone (PEEK) plates have become available for SSRF. The objective of this pilot study was to examine the use of PEEK plates for SSRF.

A prospective, observational, multi-center study of patients undergoing SSRF with PEEK plates from 4/23 through 2/24. Standard indications for SSRF were followed and the decision to use PEEK plates was left to the discretion of the treating surgeon. Basic demographics were obtained. Outcomes included the number of rib fractures stabilized with PEEK plates, complications related to SSRF, and 6-month follow-up with chest computed tomography (CT) to assess healing of PEEK repaired fracture sites, identified as complete or incomplete union. Patients also answered a five-question quality-of-life survey regarding mobility, self-care, usual activities, chest pain/discomfort, and anxiety/depression. Answers were scaled 1 to 5 (1=worse condition possible; 5=best possible condition). Patients rated their health on a scale of 0 to 100 (100=closet to their health preinjury). All data was reported as descriptive.

Forty-six patients were included. Average age was 57(±16) years; 82.6 % were male. Median ISS was 18 (IQR 14,29) and median chest-AIS was 4 (IQR 3,4). 219 rib fractures were stabilized with PEEK plates. Sixteen (34.8 %) had a combination (PEEK + titanium) procedure. Three patients had a complication: one required a second surgery for additional SSRF, and two patients were readmitted. Twenty-seven patients were surveyed at 6 months, and 19 agreed to CT scan. Eighty PEEK repaired rib fractures were assessed for healing. 80 % of fractures had complete union and no hardware failure. Quality-of-life survey averaged >4.5/category and mean overall health was 89.

PEEK plates for SSRF are safe and effective, allowing for adequate rib fracture healing and are associated with positive patient reported outcomes.

Diabetes mellitus, a chronic multi-systemic disease affecting various organs, may negatively influence health-related quality of life (HRQoL) and oral health-related quality of life (OHRQoL). This study aimed to investigate this association in a cross-sectional sample of Iraqi Kurdish diabetic patients.

Two hundred eighty-five type 2 diabetic patients participated in the survey. The EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Oral Health Impact Profile-5 (OHIP-5) instruments were used to measure HRQoL and OHRQoL, respectively.

For the HRQoL, 75%, 64%, 46%, and 20% of the participants reported "some" problems in the fields of pain/discomfort, anxiety/depression, mobility, and interruption in usual activities, respectively. Concerning the OHRQoL, difficulty in chewing, finding less flavor in food, oral/dental pain, uneasiness about appearance, and difficulty in doing usual activities were the most complained fields of OHRQoL in 35%, 30%, 29%, 25%, and 20% of the patients respectively. Women had significantly worse HRQoL and OHRQoL compared to men. There was a positive, directly proportional, and significant correlation between HRQoL and OHRQoL (Pearson correlation test = 0.455, p = 0.000).

Sex, income, duration of diabetes, and smoking were the predictive modifying factors for both HRQoL and OHRQoL. From a public health point of view, raising health awareness is urgently needed among Iraqi diabetic patients for better diabetes management, a healthier lifestyle, and regular oral hygiene measurements.

Problem-solving interventions with workplace involvement (PSI-WPI) have been shown to reduce sick leave and increase return to work in an occupational health services context. However, many employees struggle with reduced work functioning, anxiety-, and depressive symptoms up to 12 months after a sick leave episode, and it is unclear if the intervention affects outcomes other than sick leave. The aim of this study is to investigate if a PSI-WPI added to care as usual (CAU) is superior to CAU with respect to self-reported sick leave, psychological symptoms, work ability, work performance, and health after RTW when provided in primary care.

Employed individuals aged 18-59 years on sick leave (2 to 12 weeks) diagnosed by a physician at a primary care center with mild to moderate depression, anxiety, or adjustment disorder were enrolled in a two-armed cluster-randomised trial evaluating the effectiveness of a PSI-WPI. Multiple outcomes were recorded at baseline, six months, 12 months, and every fourth week during the study period. Outcomes were categorised into psychological symptoms, health, work ability, work performance, and self-reported sick leave. Data were analysed using MANOVA, GEE (Generalized Estimating Equations), and cox regression.

One hundred ninety-nine individuals responded to the invitation to participate; one participant withdrew, one was excluded as the employment ended, nine did not answer the baseline survey, and three were removed from the analysis due to missing data. The analysis included 81 subjects who received the intervention and 104 subjects who received the control. Baseline characteristics were similar across both groups. No differences between the groups were found among either variables except one. There was a significant difference between the groups in self-rated health (EQ5D) in favour of the CAU group from baseline to six-month follow-up, with a mean difference of -8.44 (-14.84, -2.04).

A problem-solving intervention with workplace involvement added to CAU did not result in statistically significant reductions in outcomes. Further research is needed to understand why problem-solving interventions appear to have an effect on sick leave in an occupational health services context and not in a primary care context.

NCT3346395, registration date 2017-11-17.

During the past decade, spinal surgical procedures have been increasingly performed on an ambulatory basis, a change in clinical practice supported only by observational evidence thus far. There have been no randomized clinical trials (RCTs) comparing ambulatory care with inpatient care after any spinal surgery.

To assess whether ambulatory care is noninferior to overnight hospital surveillance in functional outcome, as measured by Neck Disability Index (NDI), in adults after anterior cervical decompression and fusion (ACDF) for cervical radiculopathy.

This parallel group, noninferiority RCT enrolled patients at 3 tertiary neurosurgical centers in Finland (University Hospitals of Helsinki, Turku, and Oulu) between June 2019 and February 2021, with a final follow-up in October 2021. Patients aged 18 to 62 years who underwent 1-level or 2-level ACDF due to cervical radiculopathy were assessed for eligibility. After surgery, participants were randomly assigned to either ambulatory care or overnight hospital surveillance. Intention-to-treat data analyses were conducted in August 2022.

Patients randomly assigned to ambulatory care were kept under surveillance for 6 to 8 hours after surgery and then discharged. Patients assigned to overnight hospital surveillance were kept in the ward for 24 hours or longer.

The primary outcome was NDI at 6 months. A minimal important difference of 17.3 percentage points for NDI was set as the margin of noninferiority.

Among the 105 patients (mean [SD] age, 47.0 [7.9] years; 54 women [50%]) randomly assigned to ambulatory care (n = 52) or overnight hospital surveillance (n = 53), 94 (90%) completed the trial. Four (8%) patients who received ambulatory care crossed over to overnight hospital surveillance. Seventy-nine patients (75%) had a 1-level ACDF and 26 (25%) had a 2-level ACDF. At 6 months after surgery, the mean NDI was 13.3% (95% CI, 9.3%-17.3%) in the ambulatory care group and 12.2% (95% CI, 8.2%-16.2%) in the overnight hospital surveillance group (between-group mean difference, 1.1 [95% CI, -4.6 to 6.8] percentage points).

In this RCT comparing functional outcomes of ambulatory care vs overnight hospital surveillance after ACDF, ambulatory care resulted in noninferior functional outcomes.

ClinicalTrials.gov Identifier: NCT03979443.

To use the EQ-5D questionnaire with bolt-on dimensions in economic evaluation studies, new value sets are needed. In this study, we explored the feasibility of a new approach called the scaling factor model, which estimates bolt-on value sets using estimated EQ-5D dimensional weights.

We designed a 2-arm study, inviting university students to value health states with and without bolt-on items using the composite time trade-off method. We selected 25 health states from an orthogonal array and added the 5 mildest EQ-5D states in the design. In arm 1, EQ-5D without self-care and standard EQ-5D states were valued, and in arm 2, standard EQ-5D states and EQ-5D with vision were valued. By arm, we compared the mean observed values of health states with and without bolt-on item. Next, by arm, we estimated value sets for the EQ-5D with bolt-on states using both standard model and scaling factor model. Model performances were compared in terms of prediction accuracy and correlation with likelihood-based mean values.

Adding a five-level bolt-on to EQ-5D resulted in statistically lower values. This effect was consistent across 2 arms and bolt-on items. The scaling factor models outperformed the standard models in all statistics.

The scaling factor model offers a methodologically viable and low-cost option for producing value sets for EQ-5D supplemented with bolt-on items. Future studies should further test this method using other bolt-on items and more relevant study populations.

Health state valuation assumes that respondents trade off between all aspects of choice tasks and maximize their utility. Yet, respondents may use heuristic valuation processes, i.e., strategies to simplify or avoid the trade-offs that are core to health state valuation. The objective of this study is to explore if heuristic valuation processes are more prevalent for valuation from a 10-year-old child's perspective compared to the use of an adult perspective.

We reused existing data in which EQ-5D health states were valued from adult and child perspectives with composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks. Our analyses focused on comparing completion time and responding patterns across both perspectives. We also explored how reflective of a set of heuristic strategies respondents' choices were in both perspectives.

We found no evidence for systematic differences in completion time across perspectives. Generally, we find different responding patterns in child perspectives, e.g., more speeding, dominance violations, and clustering of utilities at 1.0, 0.8, and 0. Very few heuristic strategies provide a coherent explanation for the observed DCE responses.

Our results provide some, albeit indirect, evidence for differences in heuristic valuation processes between perspectives, although not across all data sources. Potential effects of heuristic valuation processes, such as transfer of responsibility, may be identified through studying responding patterns in cTTO and DCE responses.

With ageing populations and rising prevalence of key risk factors, the prevalence of many long-term conditions including chronic kidney disease (CKD) is increasing globally. Health-related quality of life (HRQoL) is important to people living with CKD but not all HRQoL determinants are modifiable. This review summarizes recently identified potentially modifiable factors affecting HRQoL for people with CKD and recent trials incorporating HRQoL as an outcome.

Considering a broad definition of 'potentially modifiable', many factors have been associated with HRQoL in recent observational studies. These include mental health conditions, symptoms, medications, health behaviours, weight-related issues, poor social support, lower education, limited literacy and directly CKD- related factors such as anaemia. Some potentially modifiable factors have been tested in CKD trials, though often with HRQoL as a secondary outcome, so may be underpowered for HRQoL. Interventions with evidence of effect on HRQoL include physical activity, education, some nutritional interventions and medications targeting CKD-related anaemia.

Clinicians should consider the range of potentially modifiable factors influencing HRQoL as part of a holistic approach to CKD care. High-quality, adequately-powered trials, with HRQoL as a primary outcome, with interventions focusing on the other potentially modifiable factors identified are needed.

Atrial fibrillation (AF) is associated with significant morbidity/mortality. AF-ablation is an increasingly used treatment. Currently, first-time AF-ablation success is 40-80% at 1-year, depending on individual factors. There is growing evidence for improved outcomes through management of AF risk-factors/comorbidities via patient education/exercise-rehabilitation. There are no studies assessing combined prehabilitation/rehabilitation in this cohort. The aim of this randomised controlled trial is to assess efficacy of comprehensive prehabilitation/rehabilitation and combining supervised exercise-training with AF risk-factor modification/education compared with standard care in people undergoing first-time AF ablation.

This single-centre pragmatic randomised controlled trial will recruit 106 adults with paroxysmal/persistent AF listed for first-time AF-ablation. Participants will be randomised 1:1 to cardiac prehabilitation/rehabilitation/education (CREED AF) intervention or standard care. Both groups will undergo AF-ablation at 8-weeks post-randomisation as per usual care. The CREED AF intervention will involve 6-weeks of prehabilitation (before AF-ablation) followed by 6-weeks rehabilitation (after AF-ablation) consisting of risk factor education/modification and supervised exercise training. Standard care will include a single 30-minute session of risk-factor education. Outcomes will be measured at baseline, 10-weeks and 12-months post AF-ablation, by researchers blinded to treatment allocation. The primary outcome is cardiorespiratory-fitness (peak oxygen uptake, VO2peak) assessed using cardiopulmonary exercise testing (CPET) at 10-weeks post-ablation. Secondary outcomes include health-related quality of life, AF recurrence/burden assessed by 7-day Holter-monitor, requirement for repeat AF-ablation, study defined major adverse cardiovascular events, and cost-effectiveness (incremental cost per quality-adjusted life year (QALY)).

This study will assess clinical-efficacy/cost-effectiveness of comprehensive prehabilitation/rehabilitation/patient-education for people undergoing first time AF-ablation. Results will inform clinical care and design of future multi-centre clinical trials.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.