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Heemsbergen W, Sinzabakira F, de Vries K, Franckena M, Christianen M, Froklage F, Westerveld H, Incrocci L. Post-treatment changes in bowel and urinary function in prostate cancer patients treated with moderate or ultra-hypofractionation: A prospective cohort study. Clin Transl Radiat Oncol 2025; 53:100955. [PMID: 40248007 PMCID: PMC12005851 DOI: 10.1016/j.ctro.2025.100955] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/08/2025] [Revised: 03/21/2025] [Accepted: 04/05/2025] [Indexed: 04/19/2025] Open
Abstract
Objective/Purpose 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. Methods 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. Results 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. Conclusion 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.
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Affiliation(s)
- W.D. Heemsbergen
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - F. Sinzabakira
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - K.C. de Vries
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - M. Franckena
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - M.E.M.C. Christianen
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - F.E. Froklage
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - H. Westerveld
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
| | - L. Incrocci
- Department of Radiotherapy, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
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Jakubczyk M, Roudijk B, Lipman SA, Stalmeier P. Making Composite Time Trade-Off Sensitive for Worse-than-Dead Health States. PHARMACOECONOMICS 2025; 43:665-675. [PMID: 40009331 DOI: 10.1007/s40273-025-01471-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 01/19/2025] [Indexed: 02/27/2025]
Abstract
OBJECTIVE 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. METHODS 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. RESULTS 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 ). CONCLUSIONS 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.
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Affiliation(s)
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
| | - Stefan A Lipman
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Peep Stalmeier
- Science Department IQ Health, Radboud University Medical Center, Nijmegen, The Netherlands
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Azizi A, Boutib A, Achak D, Purba FD, Rencz F, Saad E, Hilali A, Ahid S, Nejjari C, Stolk EA, Roudijk B, Youlyouz-Marfak I, Marfak A. Valuing health-related quality of life: an EQ-5D-5L value set for Morocco. Qual Life Res 2025; 34:1783-1796. [PMID: 40019677 PMCID: PMC12119695 DOI: 10.1007/s11136-025-03930-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/14/2025] [Indexed: 03/01/2025]
Abstract
PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Asmaa Azizi
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | - Amal Boutib
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | - Doha Achak
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | | | - Fanni Rencz
- Department of Health Policy, Corvinus University of Budapest, Budapest, Hungary
| | - Elmadani Saad
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | - Abderraouf Hilali
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | - Samir Ahid
- Euromed Research Center, Euromed University of Fez (UEMF), Fez, Morocco
- Pharmacoeconomics and Pharmacoepidemiology Research Team. Pharmacology and Toxicology Laboratory, Faculty of Medicine and Pharmacy, Mohammed V University of Rabat, Rabat, Morocco
| | - Chakib Nejjari
- Euromed Research Center, Euromed University of Fez (UEMF), Fez, Morocco
- Faculty of Medicine, Pharmacy, and Dentistry, Sidi Mohamed Ben Abdellah University, Fez, Morocco
| | - Elly A Stolk
- EuroQol Research Foundation, Marten Meesweg 107, Rotterdam, The Netherlands
| | - Bram Roudijk
- EuroQol Research Foundation, Marten Meesweg 107, Rotterdam, The Netherlands
| | - Ibtissam Youlyouz-Marfak
- Laboratory of Health Sciences and Technologies, Higher Institute of Health Sciences, Hassan First University of Settat, 26000, Settat, Morocco
| | - Abdelghafour Marfak
- Euromed Research Center, Euromed University of Fez (UEMF), Fez, Morocco.
- Ministry of Health and Social Protection, National School of Public Health, Rabat, Morocco.
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Jensen SAMS, Lauridsen SV, Fonnes S, Rosenberg J, Tønnesen H. Effect of tailored, intensive prehabilitation for risky lifestyles before ventral hernia repair on postoperative outcomes, health, and costs - study protocol for a randomised controlled trial (STRONG-Hernia). PLoS One 2025; 20:e0324002. [PMID: 40435308 PMCID: PMC12118980 DOI: 10.1371/journal.pone.0324002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2025] [Accepted: 04/14/2025] [Indexed: 06/01/2025] Open
Abstract
BACKGROUND 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. METHODS 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. DISCUSSION 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. TRIAL REGISTRATION www.clinicaltrials.gov (NCT06611462).
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Affiliation(s)
- Sofie Anne-Marie Skovbo Jensen
- WHO-CC/Clinical Health Promotion Centre, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark
- Department of Surgery, Centre for Perioperative Optimization, University of Copenhagen, Herlev Hospital, Herlev, Denmark
| | - Susanne Vahr Lauridsen
- WHO-CC/Clinical Health Promotion Centre, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark
- Department of Surgery, Centre for Perioperative Optimization, University of Copenhagen, Herlev Hospital, Herlev, Denmark
- Department of Urology, University of Copenhagen, Herlev Hospital, Herlev, Denmark
| | - Siv Fonnes
- Department of Surgery, Centre for Perioperative Optimization, University of Copenhagen, Herlev Hospital, Herlev, Denmark
| | - Jacob Rosenberg
- Department of Surgery, Centre for Perioperative Optimization, University of Copenhagen, Herlev Hospital, Herlev, Denmark
- Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Hanne Tønnesen
- WHO-CC/Clinical Health Promotion Centre, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark
- Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden
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Peasgood T, Devlin N, Ludwig K, Marten O, McDool E, Schneider P, Shah K, Mukuria C. How well do participants understand the questions asked in the Online Personal Utility Functions (OPUF) approach? A cognitive debrief of the EQ-HWB-S (EQ Health and Wellbeing Short version) valuation. Qual Life Res 2025:10.1007/s11136-025-03989-w. [PMID: 40381096 DOI: 10.1007/s11136-025-03989-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/01/2025] [Indexed: 05/19/2025]
Abstract
PURPOSE 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. METHOD 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Tessa Peasgood
- School of Medicine and Population Health, University of Sheffield, Sheffield, UK.
| | - Nancy Devlin
- School of Population and Global Health, University of Melbourne, Melbourne, Australia
| | - Kristina Ludwig
- School of Public Health, Universitat Bielefeld, Bielefeld, Germany
| | - Ole Marten
- School of Public Health, Universitat Bielefeld, Bielefeld, Germany
| | - Emily McDool
- School of Medicine and Population Health, University of Sheffield, Sheffield, UK
| | | | - Koonal Shah
- National Institute for Health and Care Excellence, London, UK
| | - Clara Mukuria
- School of Medicine and Population Health, University of Sheffield, Sheffield, UK
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Nazari JL, Ramos-Goñi JM, Gu NY, Pickard AS. An Acquired Taste: Latent Class Analysis to Compare Adolescent and Adult Preferences for EQ-5D-Y-3L Health States. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2025; 28:781-789. [PMID: 39954857 DOI: 10.1016/j.jval.2025.01.020] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/10/2024] [Revised: 10/07/2024] [Accepted: 01/29/2025] [Indexed: 02/17/2025]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Affiliation(s)
- Jonathan L Nazari
- Department of Pharmacy Systems, Outcomes, and Policy, College of Pharmacy, University of Illinois Chicago, Chicago, IL, USA.
| | - Juan M Ramos-Goñi
- Maths in Health B.V, Klimmen, The Netherlands; Decision Analysis and Support Unit, SGH, Warsaw School of Economics, Warsaw, Poland
| | - Ning Yan Gu
- School of Nursing and Health Professions, University of San Francisco, San Francisco, CA, USA
| | - A Simon Pickard
- Department of Pharmacy Systems, Outcomes, and Policy, College of Pharmacy, University of Illinois Chicago, Chicago, IL, USA; Maths in Health B.V, Klimmen, The Netherlands
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Pullenayegum EM, Jonker MF, Bailey H, Roudijk B. Immediate Death: Not So Bad If You Discount the Future but Still Worse than It Should Be. Med Decis Making 2025; 45:376-384. [PMID: 40110719 PMCID: PMC11992645 DOI: 10.1177/0272989x251325828] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2024] [Accepted: 01/23/2025] [Indexed: 03/22/2025]
Abstract
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.
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Affiliation(s)
- Eleanor M. Pullenayegum
- Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada
- Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
| | - Marcel F. Jonker
- Erasmus School of Health Policy & Management, Erasmus Centre for Health Economics and Erasmus Choice Modelling Centre, Erasmus University Rotterdam, The Netherlands
| | - Henry Bailey
- Department of Economics & HEU Centre for Health Economics, the University of the West Indies, St Augustine, Trinidad, West Indies
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
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Patel J, Qiu Q, Fluet GG, Gorin H, Gutterman J, Karunakaran K, Nolan KJ, Kaplan E, Merians AS, Adamovich SV. A randomized controlled trial of timing and dosage of upper extremity rehabilitation in virtual environments in persons with subacute stroke. Sci Rep 2025; 15:13834. [PMID: 40263476 PMCID: PMC12015485 DOI: 10.1038/s41598-025-98618-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2024] [Accepted: 04/14/2025] [Indexed: 04/24/2025] Open
Abstract
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.
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Affiliation(s)
- Jigna Patel
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA.
| | - Qinyin Qiu
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA
| | - Gerard G Fluet
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA
| | - Holly Gorin
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA
| | - Jennifer Gutterman
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA
| | | | | | - Emma Kaplan
- Kessler Foundation, West Orange, NJ, 07052, USA
| | - Alma S Merians
- Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers The State University of New Jersey, 65 Bergen St, Newark, NJ, 07101, USA
| | - Sergei V Adamovich
- Department of Biomedical Engineering, New Jersey Institute of Technology, University Heights, Newark, NJ, 07102, USA
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Abdelmegeed M, Yahya S, El-Razaz A, Soliman ES. Cross-Cultural adaptation, validity, and reliability of the arabic version of the short musculoskeletal function assessment questionnaire. J Back Musculoskelet Rehabil 2025:10538127251325425. [PMID: 40255136 DOI: 10.1177/10538127251325425] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/22/2025]
Abstract
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.
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Affiliation(s)
- Mohamed Abdelmegeed
- Orthopedic Physical Therapy Department, Cairo University, Giza, Egypt
- Department of Allied Health and Kinesiology, Hofstra University, New York, NY, USA
| | - Sara Yahya
- Ministry of Health, Elsayda Elkhadra Family Medicine Center, Cairo, Egypt
| | - Aya El-Razaz
- Physical Therapist and Nutritionist, Cairo University, Giza, Egypt
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Cao H, Yin G, Bao X, Tao H. Patient-centered evaluation of integrated care and health equity: evidence from county medical alliances in Henan province. Int J Equity Health 2025; 24:101. [PMID: 40221792 PMCID: PMC11992723 DOI: 10.1186/s12939-025-02468-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2024] [Accepted: 03/31/2025] [Indexed: 04/14/2025] Open
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Affiliation(s)
- Hengkui Cao
- School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Gang Yin
- School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xinyu Bao
- School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Hongbing Tao
- School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
- Research Center for Hospital High Quality Development, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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Hoogenboom AFH, Lipman SA. Loss aversion in EQ-5D-Y-3L: does it explain differences in willingness to trade-off life years in adults and children? THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2025:10.1007/s10198-025-01775-6. [PMID: 40220215 DOI: 10.1007/s10198-025-01775-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Accepted: 03/24/2025] [Indexed: 04/14/2025]
Abstract
INTRODUCTION 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. METHODS 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. RESULTS 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. DISCUSSION 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.
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Affiliation(s)
- Ava F H Hoogenboom
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, The Netherlands.
- Erasmus Centre for Health Economics Rotterdam (EsCHER), Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, The Netherlands.
| | - Stefan A Lipman
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, The Netherlands
- Erasmus Centre for Health Economics Rotterdam (EsCHER), Erasmus University Rotterdam, Burgemeester Oudlaan 50, Rotterdam, 3062 PA, The Netherlands
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Milrod CJ, Rubin L, Martinez B, Ollila TA, Olszewski AJ, Pelcovits A. Quality-of-life endpoints collection, reporting, and framing in randomised trials of indolent lymphomas: a systematic review. Lancet Haematol 2025; 12:e312-e317. [PMID: 40175003 DOI: 10.1016/s2352-3026(25)00032-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/12/2024] [Revised: 01/24/2025] [Accepted: 02/03/2025] [Indexed: 04/04/2025]
Abstract
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.
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Affiliation(s)
- Charles J Milrod
- Division of Hematology and Oncology, Department of Medicine, Brown University Health, Providence, RI, USA.
| | - Lila Rubin
- Department of Medicine, Brown University Health, Providence, RI, USA
| | - Boris Martinez
- Division of Hematology and Oncology, Department of Medicine, Brown University Health, Providence, RI, USA
| | - Thomas A Ollila
- Division of Hematology and Oncology, Department of Medicine, Brown University Health, Providence, RI, USA
| | - Adam J Olszewski
- Division of Hematology and Oncology, Department of Medicine, Brown University Health, Providence, RI, USA
| | - Ari Pelcovits
- Division of Hematology and Oncology, Department of Medicine, Brown University Health, Providence, RI, USA
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Al Rabayah A, Roudijk B, Purba FD, Rencz F, Jaddoua S, Siebert U. Valuation of the EQ-5D-3L in Jordan. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2025; 26:487-501. [PMID: 39225720 PMCID: PMC11937146 DOI: 10.1007/s10198-024-01712-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/19/2023] [Accepted: 07/17/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND In Jordan, no national value set is available for any preference-accompanied health utility measure. OBJECTIVE This study aims to develop a value set for EQ-5D-3L based on the preferences of the Jordanian general population. METHODS 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Abeer Al Rabayah
- Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Hall in Tirol, Austria.
- Center for Drug Policy and Technology Assessment, Pharmacy Department, King Hussein Cancer Center, Amman, Jordan.
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
| | | | - Fanni Rencz
- Department of Health Policy, Corvinus University of Budapest, Budapest, Hungary
| | - Saad Jaddoua
- Pharmacy Department, King Hussein Cancer Center, Amman, Jordan
| | - Uwe Siebert
- Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT TIROL-University for Health Sciences and Technology, Hall in Tirol, Austria
- Division of Health Technology Assessment, ONCOTYROL-Center for Personalized Cancer Medicine, Innsbruck, Austria
- Center for Health Decision Science, Departments of Epidemiology and Health Policy & Management, Harvard T.H. Chan School of Public Health, Boston, MA, USA
- Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
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Robinson T, Hill S, Oluboyede Y. A United Kingdom Value Set for the Weight-Specific Adolescent Instrument for Economic Evaluation. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2025; 28:633-642. [PMID: 39880199 DOI: 10.1016/j.jval.2025.01.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/16/2024] [Revised: 11/19/2024] [Accepted: 01/06/2025] [Indexed: 01/31/2025]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Affiliation(s)
- Tomos Robinson
- Health Economics Group, Population Health Sciences Institute, Newcastle University, Nescastle, England, UK.
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Al Sayah F, Roudijk B, El Sadig M, Al Mannaei A, Farghaly MN, Dallal S, Kaddoura R, Metni M, Elbarazi I, Kharroubi SA. A Value Set for EQ-5D-5L in the United Arab Emirates. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2025; 28:611-621. [PMID: 39880198 DOI: 10.1016/j.jval.2025.01.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/29/2024] [Revised: 11/15/2024] [Accepted: 01/06/2025] [Indexed: 01/31/2025]
Abstract
OBJECTIVES 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). METHODS 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Fatima Al Sayah
- Center for Clinical, Health Economics and Outcomes Research (CCHO), Dubai, United Arab Emirates.
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
| | - Mohamed El Sadig
- Institute of Public Health, College of Medicine and Health Sciences, United Arab Emirates University, Abu Dhabi, United Arab Emirates
| | - Asma Al Mannaei
- Department of Health, Abu Dhabi Health Authority, Abu Dhabi, United Arab Emirates
| | - Mohamad N Farghaly
- Dubai Health Authority and Dubai Medical College, Dubai, United Arab Emirates
| | - Sara Dallal
- Emirates Health Economics Society, Dubai, United Arab Emirates
| | - Rima Kaddoura
- Center for Clinical, Health Economics and Outcomes Research (CCHO), Dubai, United Arab Emirates
| | - Mirna Metni
- Center for Clinical, Health Economics and Outcomes Research (CCHO), Dubai, United Arab Emirates
| | - Iffat Elbarazi
- Institute of Public Health, College of Medicine and Health Sciences, United Arab Emirates University, Abu Dhabi, United Arab Emirates
| | - Samer A Kharroubi
- Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut, Beirut, Lebanon
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Liao M, Yang Z, Karimi M, Rand K, Luo N. How Do Individuals Value Worse-Than-Dead EQ-5D-5L Health States in Composite Time Trade-Off Tasks? A Qualitative Study. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2025; 28:622-632. [PMID: 39922298 DOI: 10.1016/j.jval.2025.01.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/11/2024] [Revised: 12/04/2024] [Accepted: 01/03/2025] [Indexed: 02/10/2025]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Affiliation(s)
- Meixia Liao
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore
| | - Zhihao Yang
- Health Services Management Department, Guizhou Medical University, Guiyang, Guizhou Province, China
| | | | - Kim Rand
- Health Services Research Center, Akershus University Hospital, Lørenskog, Norway; Maths in Health B.V., Klimmen, The Netherlands
| | - Nan Luo
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
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Kim J, Chu HH, Jung KH, Kim JH, Shin JH. Feasibility and Safety of Transradial Access for Renal Artery Embolization: A Single Center Prospective Study. Korean J Radiol 2025; 26:360-367. [PMID: 40150923 PMCID: PMC11955378 DOI: 10.3348/kjr.2024.1324] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/26/2024] [Revised: 02/07/2025] [Accepted: 02/08/2025] [Indexed: 03/29/2025] Open
Abstract
OBJECTIVE 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. MATERIALS AND METHODS 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). RESULTS 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). CONCLUSION 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.
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Affiliation(s)
- Jihoon Kim
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
| | - Hee Ho Chu
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
| | - Kyung-Hyun Jung
- Biomedical Research Center, Asan Medical Center, Seoul, Republic of Korea
| | - Jin Hyoung Kim
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
| | - Ji Hoon Shin
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
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Bailey H, Roudijk B, Brathwaite R. The EQ-5D-3L valuation study for Bermuda: using an on-line EQ-VT protocol. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2025; 26:275-297. [PMID: 38982011 PMCID: PMC11889000 DOI: 10.1007/s10198-024-01701-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/05/2024] [Accepted: 05/15/2024] [Indexed: 07/11/2024]
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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). DISCUSSION 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.
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Affiliation(s)
- Henry Bailey
- Department of Economics, The University of the West Indies, St Augustine Campus, St. Augustine, Trinidad and Tobago.
- HEU, Centre for Health Economics, The University of the West Indies, St Augustine Campus, St. Augustine, Trinidad and Tobago.
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
- Department of Psychiatry, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - Ricky Brathwaite
- Bermuda Health Council, Health Economics Directorate, Hamilton, Bermuda
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Péntek M, Jáger V, Kincses Á, Hölgyesi Á, Zrubka Z, Baji P, Kovács L, Gulácsi L. Population norms for the EQ-5D-5L for Hungary: comparison of online surveys and computer assisted personal interviews. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2025:10.1007/s10198-024-01755-2. [PMID: 39982665 DOI: 10.1007/s10198-024-01755-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/06/2024] [Accepted: 12/18/2024] [Indexed: 02/22/2025]
Abstract
BACKGROUND AND OBJECTIVES 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). METHODS 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. RESULTS '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. CONCLUSIONS 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.
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Affiliation(s)
- Márta Péntek
- University Research and Innovation Center, Health Economics Research Center, Óbuda University, Budapest, Hungary.
- Doctoral School of Innovation Management, Óbuda University, Budapest, Hungary.
| | - Viktor Jáger
- Hungarian Central Statistical Office, Budapest, Hungary
| | - Áron Kincses
- Hungarian Central Statistical Office, Budapest, Hungary
- Institute of World and Regional Economics, University of Miskolc, Miskolc, Hungary
| | - Áron Hölgyesi
- University Research and Innovation Center, Health Economics Research Center, Óbuda University, Budapest, Hungary
- Doctoral School of Molecular Medicine, Semmelweis University, Budapest, Hungary
| | - Zsombor Zrubka
- University Research and Innovation Center, Health Economics Research Center, Óbuda University, Budapest, Hungary
- Doctoral School of Innovation Management, Óbuda University, Budapest, Hungary
| | - Petra Baji
- Musculoskeletal Research Unit, University of Bristol, Bristol, UK
| | - Levente Kovács
- University Research and Innovation Center, Physiological Controls Research Center, Óbuda University, Budapest, Hungary
| | - László Gulácsi
- University Research and Innovation Center, Health Economics Research Center, Óbuda University, Budapest, Hungary
- Doctoral School of Innovation Management, Óbuda University, Budapest, Hungary
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Yan J, Humphries B, Xie R, Yin Z, Bo Z, Diao S, Cai J, Tse P, Li M, Pullenayegum E, Lee SF, Xie F. Statistical Methods for Analyzing EQ-5D in Randomized Clinical Trials: A Systematic Literature Review. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2025:S1098-3015(25)00067-1. [PMID: 39954858 DOI: 10.1016/j.jval.2025.02.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/29/2024] [Revised: 01/20/2025] [Accepted: 02/04/2025] [Indexed: 02/17/2025]
Abstract
OBJECTIVES 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). METHOD We searched 2 electronic databases (MEDLINE and EMBASE, from inception through 2021) and www. CLINICALTRIAL 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. RESULTS 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). CONCLUSIONS 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.
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Affiliation(s)
- Jiajun Yan
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
| | - Brittany Humphries
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
| | - Ruinan Xie
- Department of Applied Mathematics, Hong Kong Polytechnic University, Hong Kong, China
| | - Ziran Yin
- Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, Chapel Hill, NC, USA
| | - Zhenyan Bo
- Department of Pharmacy/Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Sichuan, China
| | - Sha Diao
- Department of Pharmacy/Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Sichuan, China
| | - Jing Cai
- Department of Mathematics and Statistics, McMaster University, Hamilton, ON, Canada
| | - Preston Tse
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
| | - Meixuan Li
- Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China; Health Technology Assessment Centre, Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou, China
| | - Eleanor Pullenayegum
- Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
| | - Shun Fu Lee
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada
| | - Feng Xie
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, ON, Canada.
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Redfern J, Li E, Maiorana A, Zecchin R, Hyun KK, Shi W, Weddell J, Liang S, Candelaria D, Briffa T, Bauman A, Figtree G, Hackett ML, Law CK, Tu Q, Lindley R, Gallagher R. Heart2Heart: a digital peer support programme for people with heart disease: protocol for a community-based, investigator-blinded randomised controlled trial conducted in Australia. BMJ Open 2025; 15:e088740. [PMID: 39947825 PMCID: PMC11831262 DOI: 10.1136/bmjopen-2024-088740] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2024] [Accepted: 02/01/2025] [Indexed: 02/19/2025] Open
Abstract
INTRODUCTION 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. METHODS AND ANALYSIS 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. ETHICS AND DISSEMINATION 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. TRIAL REGISTRATION NUMBER ACTRN12624000386538.
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Affiliation(s)
- Julie Redfern
- Sydney Nursing School, University of Sydney, Sydney, New South Wales, Australia
- Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Queensland, Australia
| | - Emily Li
- Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
| | - Andrew Maiorana
- School of Physiotherapy and Exercise Science, Curtin University-Perth City Campus, Perth, Western Australia, Australia
| | - Robert Zecchin
- Cardiac Rehabilitation Services, Westmead Hospital, Westmead, New South Wales, Australia
| | - Karice K Hyun
- School of Health Sciences, University of Sydney, Camperdown, New South Wales, Australia
| | - Wendan Shi
- Sydney Nursing School, University of Sydney, Sydney, New South Wales, Australia
| | - Joseph Weddell
- Sydney Nursing School, University of Sydney, Sydney, New South Wales, Australia
| | - Shuang Liang
- The University of Sydney, Sydney, New South Wales, Australia
| | - Dion Candelaria
- Nursing, The University of Sydney, Sydney, New South Wales, Australia
| | - Tom Briffa
- School of Population Health, University of Western Australia, Crawley, Western Australia, Australia
| | - Adrian Bauman
- School of Public Health, University of Sydney, Sydney, New South Wales, Australia
| | - Gemma Figtree
- Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
- Kolling Institute of Medical Research, Saint Leonards, New South Wales, Australia
| | - Maree L Hackett
- Faculty of Medicine, University of New South Wales, George Institute for Global Health, Camperdown, New South Wales, Australia
- Faculty of Health and Wellbeing, University of Central Lancashire, Preston, UK
| | - Chi Kin Law
- The University of Sydney, Sydney, New South Wales, Australia
| | - Qiang Tu
- Faculty of Medicine and Health, The University of Sydney, Westmead, New South Wales, Australia
| | - Richard Lindley
- Medicine, University of Sydney, Westmead, New South Wales, Australia
| | - Robyn Gallagher
- Sydney Nursing School, University of Sydney, Sydney, New South Wales, Australia
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22
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Luquiens A, Panjo H, Bonnaire C, Pelletier-Fleury N. Developing a utility value set for the Gambling Quality of Life Scale-Brief (GQoLS-Brief) using a discrete choice experiment. Qual Life Res 2025; 34:457-469. [PMID: 39592497 DOI: 10.1007/s11136-024-03835-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/05/2024] [Indexed: 11/28/2024]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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." CONCLUSIONS 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.
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Affiliation(s)
- Amandine Luquiens
- Department of Addictology, CHU Nîmes, Univ. Montpellier, Nîmes, France.
- CESP, Univ. Paris-Sud, UVSQ, INSERM, Université Paris-Saclay, Villejuif, France.
| | - Henri Panjo
- CESP, Univ. Paris-Sud, UVSQ, INSERM, Université Paris-Saclay, Villejuif, France
| | - Céline Bonnaire
- Laboratoire de Psychopathologie Et Processus de Santé, Université Paris Cité, F-92100, Boulogne Billancourt, France
- Centre de Soins d'Accompagnement Et de Prévention en Addictologie Pierre Nicole, Croix-Rouge Française, 75005, Paris, France
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23
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Nordblom NF, Hertrampf K, Habig S, Gabelmann S, Schlattmann P, Orawa H, Meyer G, Gaßmann G, Abraham J, Wobst LM, Schwendicke F. Cost-effectiveness-analysis of oral health remotivation and reinstruction in nursing homes in a cluster-randomized controlled trial. J Dent 2025; 153:105520. [PMID: 39673909 DOI: 10.1016/j.jdent.2024.105520] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2024] [Revised: 12/03/2024] [Accepted: 12/06/2024] [Indexed: 12/16/2024] Open
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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. CLINICAL SIGNIFICANCE Reinstruction and remotivation by dental assistants did not improve OHrQoL, but generated significant costs, mainly due to an uptake of dental services. TRIAL REGISTRATION ClinicalTrials.gov (Trial registration number NCT04140929).
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Affiliation(s)
- N F Nordblom
- Department of Oral Diagnostics, Digital Health and Health Services Research, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - K Hertrampf
- Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Str. 16, 24105 Kiel, Germany
| | - S Habig
- Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Str. 16, 24105 Kiel, Germany
| | - S Gabelmann
- Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Str. 16, 24105 Kiel, Germany
| | - P Schlattmann
- Institut für Medizinische Statistik, Informatik und Datenwissenschaften, Universitätsklinikum Jena, Germany
| | - H Orawa
- Institut für Medizinische Statistik, Informatik und Datenwissenschaften, Universitätsklinikum Jena, Germany
| | - G Meyer
- Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
| | - G Gaßmann
- PraxisHochschule, University of Applied Sciences, Cologne, Germany
| | - J Abraham
- Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
| | - L M Wobst
- Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
| | - F Schwendicke
- Conservative Dentistry and Periodontology, LMU University Hospital, LMU Munich, Munich, Germany.
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24
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Garratt AM, Stavem K, Shaw JW, Rand K. EQ-5D-5L value set for Norway: a hybrid model using cTTO and DCE data. Qual Life Res 2025; 34:417-427. [PMID: 39565555 PMCID: PMC11865167 DOI: 10.1007/s11136-024-03837-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/07/2024] [Indexed: 11/21/2024]
Abstract
PURPOSE To develop the Norwegian value set for the EQ-5D-5L based on interviews with a representative sample of the Norwegian adult population. METHODS 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Andrew M Garratt
- Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
- Health Services Research Unit, Akershus University Hospital, Nordbyhagen, Norway.
| | - Knut Stavem
- Health Services Research Unit, Akershus University Hospital, Nordbyhagen, Norway
- Institute of Clinical Medicine, University of Oslo, Oslo, Norway
- Department of Pulmonary Medicine, Medical Division, Akershus University Hospital, Nordbyhagen, Norway
| | | | - Kim Rand
- Health Services Research Unit, Akershus University Hospital, Nordbyhagen, Norway
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25
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Hofmann AL, Widmann J, Brandstetter L, Selig U, Haug F, Haug J, Pryss R, Mecklenburg J, Kreichgauer A, Capetian P, Hartmann CJ, Niklas C, Ritter P, Krause P, Schnitzler A, Volkmann J, Kühn AA, Heuschmann P, Haas K. Development and application of a clinical core data set for deep brain stimulation in Parkinson's disease, dystonia or tremor: from data collection to data exchange and data sharing. Neurol Res Pract 2025; 7:5. [PMID: 39881414 PMCID: PMC11780920 DOI: 10.1186/s42466-024-00362-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2024] [Accepted: 11/28/2024] [Indexed: 01/31/2025] Open
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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).
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Affiliation(s)
- Anna-Lena Hofmann
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany.
- Institute for Medical Data Science, University Hospital Würzburg, Würzburg, Germany.
| | - Jonas Widmann
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
| | - Lilly Brandstetter
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
| | - Udo Selig
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
| | - Fabian Haug
- Institute for Medical Data Science, University Hospital Würzburg, Würzburg, Germany
| | - Julian Haug
- Institute for Medical Data Science, University Hospital Würzburg, Würzburg, Germany
| | - Rüdiger Pryss
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
- Institute for Medical Data Science, University Hospital Würzburg, Würzburg, Germany
| | - Jasper Mecklenburg
- Department of Neurology and Experimental Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Andrea Kreichgauer
- Department of Neurology and Experimental Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Philipp Capetian
- Department of Neurology, University Hospital Würzburg, Würzburg, Germany
| | - Christian J Hartmann
- Institute of Clinical Neuroscience and Medical Psychology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany
| | - Christian Niklas
- Institute for Medical Informatics, University Hospital Heidelberg, Heidelberg, Germany
| | - Petra Ritter
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany
- Department of Neurology With Experimental Neurology, Brain Simulation Section, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität Zu Berlin, Berlin, Germany
- Bernstein Focus State Dependencies of Learning and Bernstein Center for Computational Neuroscience, Berlin, Germany
- Einstein Center for Neuroscience Berlin, Einstein Center Digital Future, Berlin, Germany
| | - Patricia Krause
- Department of Neurology and Experimental Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Alfons Schnitzler
- Institute of Clinical Neuroscience and Medical Psychology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany
| | - Jens Volkmann
- Department of Neurology, University Hospital Würzburg, Würzburg, Germany
| | - Andrea A Kühn
- Department of Neurology and Experimental Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Peter Heuschmann
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
- Institute for Medical Data Science, University Hospital Würzburg, Würzburg, Germany
- Clinical Trial Center, University Hospital Würzburg, Würzburg, Germany
| | - Kirsten Haas
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany
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López-Monzoni S, Hernando Benito G, Romero-Peralta S, Silgado-Martínez L, Viejo-Ayuso ME, Álvarez-Balado L, Rodríguez Matarranz E, Forné Izquierdo C, Sánchez-de-la-Torre M, Masa JF, Barbé F, García-Río F, Martínez-Nicolás A, García-Mediano B, Solano-Pérez E, Mediano O. Improving Anxiety Related to Chronic Pain Through a Sleep Circadian Intervention Program: A Pilot Study. Behav Sci (Basel) 2025; 15:40. [PMID: 39851844 PMCID: PMC11762505 DOI: 10.3390/bs15010040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 12/27/2024] [Accepted: 12/30/2024] [Indexed: 01/26/2025] Open
Abstract
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.
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Affiliation(s)
- Sonia López-Monzoni
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
| | - Gloria Hernando Benito
- Medicine Department, Universidad de Alcalá, 28805 Madrid, Spain;
- Internal Medicine Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain
| | - Sofía Romero-Peralta
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
| | - Laura Silgado-Martínez
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
| | - Maria Esther Viejo-Ayuso
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
| | - Leticia Álvarez-Balado
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
| | | | - Carles Forné Izquierdo
- Heorfy Consulting, 25007 Lleida, Spain;
- Department of Basic Medical Sciences, Universitat de Lleida, 25198 Lleida, Spain
| | - Manuel Sánchez-de-la-Torre
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
- Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, Universidad de Castilla la Mancha, 45071 Toledo, Spain
| | - Juan Fernando Masa
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
- Respiratory Department, Hospital Universitario San Pedro Alcántara, 10003 Cáceres, Spain
| | - Ferrán Barbé
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
- Translational Research in Respiratory Medicine, Hospital Universitari Arnau de Vilanova-Santa Maria, Biomedical Research Institute of Lleida (IRBLleida), 25198 Lleida, Spain
| | - Francisco García-Río
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
- Medicine Department, Universidad Autónoma de Madrid, 28049 Madrid, Spain
- Respiratory Department, Hospital Universitario La Paz, Instituto de Investigación Hospital Universitario La Paz (IdiPaz), 28046 Madrid, Spain
| | - Antonio Martínez-Nicolás
- Chronobiology Lab, Department of Physiology, College of Biology, Universidad de Murcia, Mare Nostrum Campus, IUIE, IMIB-Arrixaca, 30100 Murcia, Spain;
- Human Physiology Area, Faculty of Sport Sciences, Universidad de Murcia, Santiago de La Ribera-San Javier, 30720 Murcia, Spain
- Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), 28029 Madrid, Spain
| | - Belén García-Mediano
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
| | - Esther Solano-Pérez
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
| | - Olga Mediano
- Sleep Unit, Pneumology Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain; (S.L.-M.); (S.R.-P.); (M.E.V.-A.); (L.Á.-B.); (B.G.-M.)
- Group of Precision Medicine in Chronic Diseases, Hospital Nacional de Parapléjicos, Instituto de Investigación Sanitaria de Castilla La Mancha (IDISCAM), 45071 Toledo, Spain
- Internal Medicine Department, Hospital Universitario de Guadalajara, 19002 Guadalajara, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), 28029 Madrid, Spain; (J.F.M.); (F.B.); (F.G.-R.)
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Tungsanga S, Nantanawijit R, Kiatamornrak P, Kulvichit W, Ngoensawat U, Tachaboon S, Dinhuzen J, Chaisuriyong W, Komolpis K, Peerapornratana S, Praditpornsilpa K, Tungsanga K, Bello AK, Srisawat N. Utility of a novel point-of-care test for albuminuria in communities at high risk for chronic kidney disease in Thailand. BMJ PUBLIC HEALTH 2025; 3:e001412. [PMID: 40017920 PMCID: PMC11812891 DOI: 10.1136/bmjph-2024-001412] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/03/2024] [Accepted: 11/14/2024] [Indexed: 03/01/2025]
Abstract
Introduction 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. Methods 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. Results 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. Conclusion 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.
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Affiliation(s)
- Somkanya Tungsanga
- Medicine, Chulalongkorn University, Bangkok, Thailand
- Medicine, University of Alberta, Edmonton, Alberta, Canada
| | | | | | - Win Kulvichit
- Department of Medicine, Chulalongkorn University, Bangkok, Thailand
| | - Umphan Ngoensawat
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | - Sasipa Tachaboon
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | - Janejira Dinhuzen
- Thai Red Cross Society, Bangkok, Thailand
- Chulalongkorn University, Bangkok, Thailand
| | | | - Kittinan Komolpis
- Chulalongkorn University, Bangkok, Thailand
- Research Unit of Chulalongkorn University, Bangkok, Thailand
| | - Sadudee Peerapornratana
- Thai Red Cross Society, Bangkok, Thailand
- Department of Medicine, Chulalongkorn University, Bangkok, Thailand
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28
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Mukuria C, Rowen D, Mulhern B, McDool E, Kharroubi S, Bjorner JB, Brazier JE. The Short Form 6 Dimensions (SF-6D): Development and Evolution. APPLIED HEALTH ECONOMICS AND HEALTH POLICY 2025; 23:19-33. [PMID: 39460886 PMCID: PMC11729076 DOI: 10.1007/s40258-024-00919-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 09/10/2024] [Indexed: 10/28/2024]
Abstract
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.
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Affiliation(s)
- Clara Mukuria
- Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UK.
| | - Donna Rowen
- Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UK
| | - Brendan Mulhern
- Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia
| | - Emily McDool
- Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UK
| | - Samer Kharroubi
- Department of Nutrition and Food Sciences at the American University of Beirut, Beirut, Lebanon
| | | | - John E Brazier
- Division of Population Health, School of Medicine and Population Health, University of Sheffield, Sheffield, UK
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Bauman ZM, Tian Y, Puthoff G, Whitbeck SA, Gardner S, White TW. An early analysis of polyetheretherketone (PEEK) plates for the surgical stabilization of rib fractures: A pilot study. Injury 2024; 55:111969. [PMID: 39499986 DOI: 10.1016/j.injury.2024.111969] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/06/2024] [Revised: 09/30/2024] [Accepted: 10/14/2024] [Indexed: 12/02/2024]
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION PEEK plates for SSRF are safe and effective, allowing for adequate rib fracture healing and are associated with positive patient reported outcomes.
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Affiliation(s)
- Zachary M Bauman
- Division of Trauma, Emergency General Surgery and Critical Care Surgery, Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA.
| | - Yuqian Tian
- Division of Trauma, Emergency General Surgery and Critical Care Surgery, Department of Surgery, University of Nebraska Medical Center, Omaha, NE, USA.
| | - Gregory Puthoff
- Division of Cardiothoracic Radiology, Department of Radiology and Radiologic Science, Medical University of South Carolina, Charleston, SC, USA.
| | - Sarah Ann Whitbeck
- Chief Executive Officer - Chest Wall Injury Society, Salt Lake City, UT, USA.
| | - Scott Gardner
- Division of Trauma and Critical Care Surgery, Department of Surgery, Intermountain Medical Center, Salt Lake City, UT, USA.
| | - Thomas W White
- Division of Trauma and Critical Care Surgery, Department of Surgery, Intermountain Medical Center, Salt Lake City, UT, USA.
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Mahmood MK, Mohammedameen E, Jaff S, Kurda HA, Tassery H, Lan R, Tardivo D, Qadir BH, Fatih MT, Abdulghfor MA. Health and Oral Health-Related Quality of Life and the Associated Factors in Diabetic Patients. Cureus 2024; 16:e75269. [PMID: 39776729 PMCID: PMC11706570 DOI: 10.7759/cureus.75269] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/07/2024] [Indexed: 01/11/2025] Open
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSION 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.
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Affiliation(s)
| | - Esra Mohammedameen
- Internal Medicine, College of Medicine - University of Sulaimani, Sulaymaniyah, IRQ
| | - Salman Jaff
- Pharmacology, College of Pharmacy, Komar University of Science and Technology, Sulaymaniyah, IRQ
| | - Handren A Kurda
- Orthodontics, College of Medicine - University of Sulaimani, Sulaymaniyah, IRQ
| | - Herve Tassery
- Odontology, Timone Hospital, Aix-Marseille University, Marseille, FRA
| | - Romain Lan
- Odontology, Timone Hospital, Aix-Marseille University, Marseille, FRA
| | - Delphine Tardivo
- Odontology, Timone Hospital, Aix-Marseille University, Marseille, FRA
| | - Balen H Qadir
- Prosthodontics, College of Dentistry, Komar University of Science and Technology, Sulaymaniyah, IRQ
| | - Mohammed T Fatih
- Periodontics, College of Dentistry, Komar University of Science and Technology, Sulaymaniyah, IRQ
| | - Mohammed A Abdulghfor
- Oral and Maxillofacial Surgery, College of Medicine - University of Sulaimani, Sulaymaniyah, IRQ
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31
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Eklund A, Karlsson I, Bergström G, Lisa H, Elisabeth BB. The effectiveness of a problem-solving intervention with workplace involvement on self-reported sick leave, psychological symptoms and work ability: a cluster randomised clinical trial. BMC Public Health 2024; 24:3052. [PMID: 39501245 PMCID: PMC11536685 DOI: 10.1186/s12889-024-20564-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2024] [Accepted: 10/29/2024] [Indexed: 11/09/2024] Open
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSIONS 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. TRIAL REGISTRATION NCT3346395, registration date 2017-11-17.
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Affiliation(s)
- Andreas Eklund
- Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Box 210, Sweden.
| | - Ida Karlsson
- Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Box 210, Sweden
| | - Gunnar Bergström
- Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Box 210, Sweden
- Department of Occupational Health, Psychology and Sports Science, Faculty of Health and Occupational Studies, University of Gävle, Gävle, Sweden
| | - Holmlund Lisa
- Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Box 210, Sweden
- Department of Neurobiology, Care Sciences and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden
| | - Björk Brämberg Elisabeth
- Institute of Environmental Medicine, Unit of Intervention and Implementation Research for Worker Health, Karolinska Institutet, Karolinska Institutet, 171 77, Stockholm, Box 210, Sweden
- School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
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Lönnrot K, Taimela S, Satopää J, Saarenpää I, Leinonen V, Kivelev J, Silvasti-Lundell M, Förster J, Pitkänen M, Raj R, Kauppinen M, Westermarck R, Jahromi BR, Koski-Palkén A, Seppälä M, Kivipelto L, Antinheimo J, Korja M, Czuba T, Järvinen TLN. Ambulatory Care vs Overnight Hospitalization After Anterior Surgery for Cervical Radiculopathy: The FACADE Randomized Clinical Trial. JAMA Netw Open 2024; 7:e2447459. [PMID: 39602120 PMCID: PMC12124692 DOI: 10.1001/jamanetworkopen.2024.47459] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2024] [Accepted: 09/28/2024] [Indexed: 11/29/2024] Open
Abstract
Importance 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. Objective 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. Design, Setting, and Participants 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. Interventions 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. Main Outcomes and Measures 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. Results 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). Conclusions and Relevance In this RCT comparing functional outcomes of ambulatory care vs overnight hospital surveillance after ACDF, ambulatory care resulted in noninferior functional outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT03979443.
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Affiliation(s)
- Kimmo Lönnrot
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
- Finnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland
- Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Simo Taimela
- Finnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland
- Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Jarno Satopää
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Ilkka Saarenpää
- Neurocenter, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland
| | - Ville Leinonen
- Department of Neurosurgery, Kuopio University Hospital, Kuopio, Finland
- Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland
| | - Juri Kivelev
- Neurocenter, Department of Neurosurgery, Turku University Hospital and University of Turku, Turku, Finland
| | - Marja Silvasti-Lundell
- Department of Anesthesiology, Intensive Care and Pain Medicine, Helsinki University Hospital, Helsinki, Finland
| | - Johannes Förster
- Department of Anesthesia, Orthopedic Hospital Orton, Helsinki, Finland
| | - Mikko Pitkänen
- Department of Anesthesia, Orthopedic Hospital Orton, Helsinki, Finland
| | - Rahul Raj
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Mikko Kauppinen
- Research Unit of Clinical Neuroscience, University of Oulu, Oulu, Finland
- Department of Neurosurgery, Oulu University Hospital, Oulu, Finland
| | - Riitta Westermarck
- Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Turku, Finland
- Department of Anesthesiology and Intensive Care, University of Turku, Turku, Finland
| | - Behnam Rezai Jahromi
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Anniina Koski-Palkén
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Matti Seppälä
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Leena Kivipelto
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Jussi Antinheimo
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Miikka Korja
- Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
| | - Tomasz Czuba
- Department of Clinical Sciences, Orthopaedics, Lund University, Lund, Sweden
- Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
| | - Teppo L. N. Järvinen
- Finnish Centre for Evidence-Based Orthopaedics, University of Helsinki, Helsinki, Finland
- Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
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Yang Z, Rand K, Luo N. Valuation of Multidimensional Health States With a Bolt-On: Is There a Shortcut? VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1544-1552. [PMID: 38977194 DOI: 10.1016/j.jval.2024.06.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/04/2024] [Revised: 06/21/2024] [Accepted: 06/21/2024] [Indexed: 07/10/2024]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
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Affiliation(s)
- Zhihao Yang
- Health Services Management Department, Guizhou Medical University, Guian, China; Medical Psychiatry and Psychotherapy, Erasmus Medical Center, Rotterdam, The Netherlands
| | - Kim Rand
- Health Services Research Center, Akershus University Hospital, Lørenskog, Norway; Math in Health B.V., Rotterdam, The Netherlands
| | - Nan Luo
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
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Lipman SA, Reckers-Droog VT. Comparing heuristic valuation processes between health state valuation from child and adult perspectives. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2024; 25:1345-1360. [PMID: 38308719 PMCID: PMC11442527 DOI: 10.1007/s10198-023-01668-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/03/2023] [Accepted: 12/21/2023] [Indexed: 02/05/2024]
Abstract
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSION 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.
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Affiliation(s)
- Stefan A Lipman
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.
- Erasmus Centre for Health Economics Research Rotterdam, Erasmus University Rotterdam, Rotterdam, The Netherlands.
| | - Vivian T Reckers-Droog
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
- Erasmus Centre for Health Economics Research Rotterdam, Erasmus University Rotterdam, Rotterdam, The Netherlands
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Fraser SDS, Phillips T. Quality of life in people with chronic kidney disease: focusing on modifiable risk factors. Curr Opin Nephrol Hypertens 2024; 33:573-582. [PMID: 39115435 PMCID: PMC11426990 DOI: 10.1097/mnh.0000000000001013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/28/2024]
Abstract
PURPOSE OF REVIEW 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. RECENT FINDINGS 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. SUMMARY 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.
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Affiliation(s)
- Simon D S Fraser
- School of Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK
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Davis J, Talati Z, Whalan S, Billingham W, D’Vaz N, Gibson L, Prescott SL, Silva DT. Cohort Profile: The ORIGINS pregnancy and birth cohort. Int J Epidemiol 2024; 53:dyae146. [PMID: 39521953 PMCID: PMC11550191 DOI: 10.1093/ije/dyae146] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2024] [Accepted: 10/24/2024] [Indexed: 11/16/2024] Open
Affiliation(s)
- Jacqueline Davis
- The Kids Research Institute Australia, Nedlands, WA, Australia
- Medical School, University of Western Australia, Crawley, WA, Australia
- School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
- School of Population Health, Curtin University, Bentley, WA, Australia
| | - Zenobia Talati
- The Kids Research Institute Australia, Nedlands, WA, Australia
- Medical School, University of Western Australia, Crawley, WA, Australia
- School of Population Health, Curtin University, Bentley, WA, Australia
| | - Sarah Whalan
- The Kids Research Institute Australia, Nedlands, WA, Australia
| | | | - Nina D’Vaz
- The Kids Research Institute Australia, Nedlands, WA, Australia
- School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
| | - Lisa Gibson
- The Kids Research Institute Australia, Nedlands, WA, Australia
- School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
| | - Susan L Prescott
- The Kids Research Institute Australia, Nedlands, WA, Australia
- Medical School, University of Western Australia, Crawley, WA, Australia
- School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia
- Nova Institute for Health, Baltimore, MD, USA
- Family and Community Medicine, University of Maryland, Baltimore, MD, USA
| | - Desiree T Silva
- The Kids Research Institute Australia, Nedlands, WA, Australia
- Medical School, University of Western Australia, Crawley, WA, Australia
- School of Population Health, Curtin University, Bentley, WA, Australia
- Joondalup Health Campus, Joondalup, WA, Australia
- Perth Children’s Hospital, Nedlands, WA, Australia
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Chandan N, Matthews V, He H, Lachlan T, Lim VG, Joshi S, Hee SW, Noufaily A, Parkes E, Patel S, Andronis L, Shakespeare J, Eftekhari H, Ali A, McGregor G, Osman F. Cardiac prehabilitation, rehabilitation and education in first-time atrial fibrillation (AF) ablation (CREED AF): Study protocol for a randomised controlled trial. PLoS One 2024; 19:e0310951. [PMID: 39361572 PMCID: PMC11449326 DOI: 10.1371/journal.pone.0310951] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/15/2024] [Accepted: 09/01/2024] [Indexed: 10/05/2024] Open
Abstract
BACKGROUND 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. METHODS 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)). CONCLUSIONS 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. TRIAL REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT06042231.Date registered: September 18, 2023.
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Affiliation(s)
- Nakul Chandan
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Centre for Healthcare & Communities, Coventry University, Coventry, United Kingdom
| | - Violet Matthews
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Research and Development Institutes of Excellence, University Hospital Coventry, Coventry, United Kingdom
| | - Hejie He
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Thomas Lachlan
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Ven Gee Lim
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Shivam Joshi
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Research and Development Institutes of Excellence, University Hospital Coventry, Coventry, United Kingdom
| | - Siew Wan Hee
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Research and Development Institutes of Excellence, University Hospital Coventry, Coventry, United Kingdom
| | - Angela Noufaily
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Edward Parkes
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Shilpa Patel
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Lazaros Andronis
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Joanna Shakespeare
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Helen Eftekhari
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Asad Ali
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
| | - Gordon McGregor
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Centre for Healthcare & Communities, Coventry University, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
| | - Faizel Osman
- Institute for Cardio-Metabolic Medicine, University Hospital Coventry, Coventry, United Kingdom
- Centre for Healthcare & Communities, Coventry University, Coventry, United Kingdom
- Warwick Medical School, University of Warwick, Coventry, United Kingdom
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Jonker MF, Roudijk B. A New and Improved Experimental Design for the Discrete Choice Experiment Module of the EuroQol Valuation Technology Protocol. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1311-1317. [PMID: 38977189 DOI: 10.1016/j.jval.2024.05.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/06/2023] [Revised: 05/07/2024] [Accepted: 05/30/2024] [Indexed: 07/10/2024]
Abstract
OBJECTIVES The EuroQol Valuation Technology (EQ-VT) protocol, which is used to value the EQ-5D-5L instrument, comprises a composite time trade-off and a discrete choice experiment (DCE) module. Despite significant limitations, the DCE module has not been updated since its inception in 2012. This study aimed to update the EQ-VT DCE design using state-of-the-art methods. METHODS DCE data from 19 EQ-5D-5L valuation studies were summarized using a Bayesian hierarchical meta-analysis model, which created the priors for our Bayesian efficient DCE design. This design comprised 20 subdesigns, each with 12 choice tasks, and included 2 levels that overlapped to reduce the complexity of the choice tasks. The relative efficiency and robustness of the new design were established by comparing the D-errors and minimal sample size requirements for the 19 within-sample and 7 out-of-sample countries with the previous DCE design. RESULTS The updated DCE design shows large reductions in the D-error: by 20% and 22% for the 19 within-sample and 7 out-of-sample countries, respectively. Sample size requirements were also reduced, resulting in an average reduction of 45% for both the within and out-of-sample countries. CONCLUSIONS The updated DCE design outperforms the current EQ-VT design. Given its enhanced performance and reduced complexity, it is set to replace the existing DCE design in future EQ-5D-5L valuation studies using the EQ-VT protocol.
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Affiliation(s)
- Marcel F Jonker
- Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands.
| | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands; Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus Medical Center, Rotterdam, The Netherlands
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Sokolova V, Faller J, Asfia SKBM, Engel L. Assessing the psychometric performance of the EQ-5D-5L among informal caregivers of people with dementia. Qual Life Res 2024; 33:2693-2704. [PMID: 39046615 PMCID: PMC11452493 DOI: 10.1007/s11136-024-03737-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/12/2024] [Indexed: 07/25/2024]
Abstract
PURPOSE This study aimed to examine the psychometric performance of the EQ-5D-5L in informal caregivers of people with dementia. METHODS Data were obtained from an online survey administered to informal caregivers of people with dementia in Australia. Known-group comparisons were examined by formulating 15 a priori hypotheses, where a difference was made between weak and strong hypotheses. Group comparisons were tested using the non-parametric Wilcoxon-rank and the Kruskal-Wallis test, as well as regression analysis. Floor and ceiling effects were considered to be present if more than 15% of respondents achieved the lowest or highest possible score, respectively. RESULTS In total, 212 informal caregivers of people with dementia were included in the analysis. On average, participants were 47 years old (SD: 17) and 61% of them were female. The mean EQ-5D-5L utility score was 0.88 (SD: 0.16) and the mean EQ-VAS was 72.47 (SD: 17.86). While there was no floor effect, 26% reported full health. Nine strong and three weak hypotheses were confirmed, supporting the ability of the EQ-5D-5L to discriminate between groups with respect to: self-reported health status, happiness levels, presence of mental or physical health conditions, ability to engage in enjoyable activities, and availability of support. CONCLUSION Findings provide supporting evidence for the EQ-5D-5L in terms of its discriminant validity in informal caregivers of patients with dementia. However, the present ceiling effect suggests that the sensitivity of the EQ-5D-5L to detect improvements may be limited. Further studies are warranted examining other psychometric criteria, including reliability and responsiveness to change.
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Affiliation(s)
- Valeriia Sokolova
- School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University, Melbourne, VIC, Australia.
| | - Jan Faller
- School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University, Melbourne, VIC, Australia
| | | | - Lidia Engel
- School of Public Health and Preventive Medicine, Monash University Health Economics Group, Monash University, Melbourne, VIC, Australia
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Glavas C, Scott D, Sood S, George ES, Daly RM, Gvozdenko E, de Courten B, Jansons P. Exploring the Feasibility of Digital Voice Assistants for Delivery of a Home-Based Exercise Intervention in Older Adults With Obesity and Type 2 Diabetes Mellitus: Randomized Controlled Trial. JMIR Aging 2024; 7:e53064. [PMID: 39270212 PMCID: PMC11437229 DOI: 10.2196/53064] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Revised: 05/05/2024] [Accepted: 06/14/2024] [Indexed: 09/15/2024] Open
Abstract
BACKGROUND Current clinical guidelines for the management of type 2 diabetes mellitus (T2DM) in older adults recommend the use of antihyperglycemic medications, monitoring of blood glucose levels, regular exercise, and a healthy diet to improve glycemic control and reduce associated comorbidities. However, adherence to traditional exercise programs is poor (<35%). Common barriers to adherence include fear of hypoglycemia and the need for blood glucose level monitoring before exercise. Digital health strategies offer great promise for managing T2DM as they facilitate patient-practitioner communication, support self-management, and improve access to health care services for underserved populations. We have developed a novel web-based software program allowing practitioners to create tailored interventions and deliver them to patients via digital voice assistants (DVAs) in their own homes. OBJECTIVE We aim to evaluate the feasibility of a 12-week, home-based, personalized lifestyle intervention delivered and monitored by DVAs for older adults with obesity and T2DM. METHODS In total, 50 older adults with obesity aged 50-75 years with oral hypoglycemic agent-treated T2DM were randomized to the intervention (DVA, n=25) or a control group (n=25). Participants allocated to the DVA group were prescribed a home-based muscle strengthening exercise program (~20- to 30-min sessions) and healthy eating intervention, delivered via DVAs (Alexa Echo Show 8; Amazon) using newly developed software ("Buddy Link"; Great Australian Pty Ltd). Control group participants received generalized physical activity information via email. Outcomes were feasibility, DVA usability (System Usability Scale), and objectively assessed physical activity and sedentary time (wrist-worn accelerometers). RESULTS In total, 45 (90%) out of 50 participants completed this study. Mean adherence to prescribed exercise was 85% (SD 43%) with no intervention-related adverse events. System usability was rated above average (70.4, SD 16.9 out of 100). Compared with controls, the DVA group significantly decreased sedentary time (mean difference -67, SD 23; 95% CI -113 to -21 min/d), which was represented by a medium to large effect size (d=-0.6). CONCLUSIONS A home-based lifestyle intervention delivered and monitored by health professionals using DVAs was feasible for reducing sedentary behavior and increasing moderate-intensity activity in older adults with obesity and T2DM. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000307808; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381364&isReview=true.
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Affiliation(s)
- Costas Glavas
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
| | - David Scott
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
- Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia
| | - Surbhi Sood
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
| | - Elena S George
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
| | - Robin M Daly
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
| | | | - Barbora de Courten
- Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia
- School of Health and Biomedical Sciences, RMIT University, Bundoora, Australia
| | - Paul Jansons
- Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia
- Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia
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Liao M, Yang Z, Rand K, Luo N. Testing "Pits" Time Trade-Off: Can Data Quality be Improved by Removing Death From Valuation of Health States? VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1261-1269. [PMID: 38795961 DOI: 10.1016/j.jval.2024.05.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/18/2023] [Revised: 03/26/2024] [Accepted: 05/01/2024] [Indexed: 05/28/2024]
Abstract
OBJECTIVES Composite time trade-off (cTTO) often exhibits issues such as a value clustering at -1, potentially due to suboptimal valuation task design. We developed a novel time trade-off which uses the "pits" state as an anchor state and enables a unified time trade-off procedure for all health states (referred to as "pTTO"). This study aimed to test the pTTO for valuation of EQ-5D-5L health states. METHODS A total of 120 members of the general public were invited to value 3 pairs of dominant/dominated EQ-5D-5L states using both cTTO and pTTO and the "pits" state using cTTO. We compared the pTTO with cTTO in terms of feasibility (interviewer-rated task-completing difficulty), acceptability (participant-reported task experience), value distribution, logical consistency, and discriminatory ability (using the standardized response mean, an effect size measure, derived from 3 pairwise comparisons of states with dominant/dominated relationship). RESULTS The pTTO demonstrated similar feasibility to cTTO but slightly lower acceptability. The pTTO values exhibited a smoother and more continuous distribution compared with cTTO values. Relative to the cTTO, the pTTO showed higher individual-level logical consistency rate for the pairs comprising severe states (stringent criterion: 53.04% vs 17.39%; less stringent criterion: 82.61% vs 78.26%). The standardized response mean value based on pTTO values were higher than those based on cTTO values for the pair comprising severe states (0.388 vs -0.140). CONCLUSIONS The pTTO appeared to be feasible and acceptable to value EQ-5D-5L states. The pTTO values were less clustered, more logically consistent, and discriminative compared with the cTTO values for severe health states.
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Affiliation(s)
- Meixia Liao
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore
| | - Zhihao Yang
- Health Services Management Department, Guizhou Medical University, Guiyang, Guizhou Province, China
| | - Kim Rand
- Health Services Research Center, Akershus University Hospital, Lørenskog, Norway; Maths in Health B.V., Rotterdam, The Netherlands
| | - Nan Luo
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
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Sten-Gahmberg S, Pedersen K, Harsheim IG, Løyland HI, Snilsberg Ø, Iversen T, Godager G, Sæther EM, Abelsen B. Pragmatic randomized controlled trial comparing a complex telemedicine-based intervention with usual care in patients with chronic conditions. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2024; 25:1275-1289. [PMID: 38291176 PMCID: PMC11377648 DOI: 10.1007/s10198-023-01664-w] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/22/2023] [Accepted: 12/21/2023] [Indexed: 02/01/2024]
Abstract
This study evaluates a complex telemedicine-based intervention targeting patients with chronic health problems. Computer tablets and home telemonitoring devices are used by patients to report point-of-care measurements, e.g., blood pressure, blood glucose or oxygen saturation, and to answer health-related questions at a follow-up center. We designed a pragmatic randomized controlled trial to compare the telemedicine-based intervention with usual care in six local centers in Norway. The study outcomes included health-related quality of life (HRQoL) based on the EuroQol questionnaire (EQ-5D-5L), patient experiences, and utilization of healthcare. We also conducted a cost-benefit analysis to inform policy implementation, as well as a process evaluation (reported elsewhere). We used mixed methods to analyze data collected during the trial (health data, survey data and interviews with patients and health personnel) as well as data from national health registers. 735 patients were included during the period from February 2019 to June 2020. One year after inclusion, the effects on the use of healthcare services were mixed. The proportion of patients receiving home-based care services declined, but the number of GP contacts increased in the intervention group compared to the control group. Participants in the intervention group experienced improved HRQoL compared to the control group and were more satisfied with the follow-up of their health. The cost-benefit of the intervention depends largely on the design of the service and the value society places on improved safety and self-efficacy.
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Affiliation(s)
- Susanna Sten-Gahmberg
- Oslo Economics, Klingenberggata 7, 0161, Oslo, Norway.
- The Finnish Centre for Pensions, 00065, ELÄKETURVAKESKUS, Finland.
| | - Kine Pedersen
- Oslo Economics, Klingenberggata 7, 0161, Oslo, Norway
- Department of Health Management and Health Economics, University of Oslo, Postboks 1089 Blindern, 0317, Oslo, Norway
| | | | | | - Øyvind Snilsberg
- Department of Health Management and Health Economics, University of Oslo, Postboks 1089 Blindern, 0317, Oslo, Norway
| | - Tor Iversen
- Department of Health Management and Health Economics, University of Oslo, Postboks 1089 Blindern, 0317, Oslo, Norway
| | - Geir Godager
- Department of Health Management and Health Economics, University of Oslo, Postboks 1089 Blindern, 0317, Oslo, Norway
| | | | - Birgit Abelsen
- Norwegian Centre for Rural Medicine, Department of Community Medicine, UiT - The Arctic University of Norway, 9037, Tromsø, Norway
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Roudijk B, Jonker MF, Bailey H, Pullenayegum E. A Direct Comparison Between Discrete Choice With Duration and Composite Time Trade-Off Methods: Do They Produce Similar Results? VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1280-1288. [PMID: 38843979 DOI: 10.1016/j.jval.2024.05.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/09/2024] [Revised: 05/02/2024] [Accepted: 05/17/2024] [Indexed: 07/14/2024]
Abstract
OBJECTIVES Discrete choice experiments including a duration attribute (DCEd) represent a promising candidate method for valuing health-related quality-of-life instruments. However, it has not been established that DCEd can produce similar results as composite time trade-off (cTTO) or EuroQol Valuation Technology (EQ-VT) valuations of the EQ-5D-5L instrument. This study provides a direct comparison between cTTO and EQ-VT, and DCEd valuation methods. METHODS An EQ-VT study was conducted in Trinidad and Tobago to value the EQ-5D-5L. 1079 respondents each completed 10 cTTO tasks and 12 discrete choice experiments tasks without a duration attribute. A separate sample of 970 respondents each completed 18 split-triplet DCEd tasks. Several regression models were applied to the EQ-VT data, and the DCEd data were analyzed using mixed logit models with an exponential discount rate. The estimated values were compared using scatterplots and Bland-Altman plots. RESULTS The ordering of dimensions was identical in level 5 for cTTO/EQ-VT and DCEd models, with pain/discomfort being the most important dimension and usual activities being least important. cTTO/EQ-VT models produced a value for state 55555 ranging between -0.52 and -0.69, whereas this was -0.543 for the nonlinear mixed logit model for the DCEd data. Scatterplots and Bland-Altman plots suggested excellent agreement between cTTO/EQ-VT and DCEd-based estimates. CONCLUSIONS CTTO/EQ-VT and DCEd valuations produce similar results when correcting DCEd for nonlinear time preferences. The ordering of importance of the dimensions and scale are identical, suggesting that the 2 methods measure the same construct and produce similar results.
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Affiliation(s)
- Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands; Department of Psychiatry, Erasmus University Medical Center, Rotterdam, The Netherlands.
| | - Marcel F Jonker
- Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Centre for Health Economics Rotterdam, Erasmus University Rotterdam, Rotterdam, The Netherlands; Erasmus Choice Modelling Centre, Erasmus University Rotterdam, Rotterdam, The Netherlands
| | - Henry Bailey
- Department of Economics, The University of the West Indies, St Augustine Campus, St Augustine, Trinidad and Tobago; HEU, Centre for Health Economics, The University of the West Indies, St Augustine Campus, St Augustine, Trinidad and Tobago
| | - Eleanor Pullenayegum
- Child Health Evaluative Sciences, The Hospital for Sick Children, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada
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McDool E, Mukuria C, Peasgood T. Psychometric Performance of the EQ Health and Wellbeing Short in a United Kingdom Population Sample. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1215-1224. [PMID: 38795959 DOI: 10.1016/j.jval.2024.05.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/04/2023] [Revised: 04/22/2024] [Accepted: 05/13/2024] [Indexed: 05/28/2024]
Abstract
OBJECTIVES This study assessed the psychometric performance and construct validity of the EQ Health and Wellbeing Short (EQ-HWB-S), using a validated measure, the EQ-5D-5L, as a comparator. METHODS The experimental version of the EQ-HWB-S was compared with the EQ-5D-5L to assess the psychometric performance of the measures. Data were drawn from the valuation stages of the Extending the Quality-Adjusted Life-Year project (UK general population, n = 429) and the EQ-5D-5L UK valuation pilot study (UK general population, n = 248). Construct validity was assessed based on convergent validity, using Spearman correlations and Pearson correlations. Known-group validity was assessed by estimating effect sizes to assess the ability of the EQ-HWB-S and EQ-5D-5L to discriminate between known groups based on "healthy" status, presence of a long-term condition, health and life satisfaction, age, and employment status. The degree of agreement in utility values across instruments was also evaluated using Bland-Altman plots. RESULTS Strong associations (rs ≥ 0.5, P < .001) were found between conceptually overlapping dimensions and the utility scores of the EQ-HWB-S and EQ-5D-5L. The instruments performed comparably in discriminating between known groups including healthy versus unhealthy groups (based on the visual analog scale ≥ 80), long-term condition (vs no long-term condition), and above versus below average health and life satisfaction and employed (vs unemployed and long-term sick). CONCLUSIONS The EQ-HWB-S performs favorably with utility values successfully discriminating between groups in which differences are expected. Convergence between the EQ-HWB-S and EQ-5D-5L is evident, especially between conceptually overlapping dimensions.
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Affiliation(s)
- Emily McDool
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Sheffield, England, UK
| | - Clara Mukuria
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Sheffield, England, UK.
| | - Tessa Peasgood
- Sheffield Centre for Health and Related Research (SCHARR), University of Sheffield, Sheffield, England, UK
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Ativor V, Konadu-Yeboah D, O'Marr J, Brown K, Rodarte P, Kumah R, Quartey R, Awariyah D, Konadu P, Baidoo PK, Okike K, Morshed S, Shearer D, Roberts H. Predictors of quality of life, economic impact, and loss to follow-up after open tibial shaft fractures in Ghana. OTA Int 2024; 7:e340. [PMID: 39006124 PMCID: PMC11239167 DOI: 10.1097/oi9.0000000000000340] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2023] [Revised: 04/05/2024] [Accepted: 05/15/2024] [Indexed: 07/16/2024]
Abstract
Objectives Open tibia fractures are associated with substantial morbidity and impact on quality of life. Despite increasing incidence in low-resource settings, most open tibia fracture research comes from high-resource settings. This study aimed to assess the impact of socioeconomic status on treatment modality and evaluate predictors of health-related quality of life following open tibia fractures in Ghana. Design A single-center prospective observational study was conducted in Kumasi, Ghana, from May 2020 to April 2022. Adults with open tibial shaft fractures presenting within 2 weeks of injury were eligible. Demographics, comorbidities, socioeconomic factors, and hospital course were collected at enrollment. Follow-up was scheduled at 8, 12, 26, and 52 weeks. A telephone survey assessing reasons for loss to follow-up was initiated on enrollment completion. Results A total of 180 patients were enrolled. Most patients were employed before injury (79.9%), had government insurance (67.2%), and were from rural areas (59.4%). Fracture classification was primarily Gustilo-Anderson type 3A (49.1%). No relationship between socioeconomic predictors and treatment modality was identified. The largest barriers to follow-up were preference for bonesetter treatment (63.1%), treatment cost (48.8%), and travel cost (29.8%). Of the lost to follow-up patients contacted, 67 (79.8%) reported receiving traditional bonesetter care. Reasons for seeking traditional bonesetter care included ease of access (83.6%), lower cost (77.6%), and familial influence (50.7%). Conclusion No association was identified between socioeconomic predictors and choice of treatment. Bonesetter treatment plays a substantial role in the care of open tibia fractures in Ghana, largely because of ease of access and lower cost.
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Affiliation(s)
- Vincent Ativor
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Dominic Konadu-Yeboah
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Jamieson O'Marr
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - Kelsey Brown
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - Patricia Rodarte
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - Ralph Kumah
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Ralph Quartey
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Dominic Awariyah
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Peter Konadu
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Paa Kwesi Baidoo
- Komfo Anokye Teaching Hospital, Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti Region, Ghana
| | - Kanu Okike
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - Saam Morshed
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - David Shearer
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
| | - Heather Roberts
- Institute for Global Orthopaedics and Traumatology, University of California, San Francisco, San Francisco, CA
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Abellan-Perpiñan JM, Martinez-Perez JE, Sanchez-Martinez FI, Pinto-Prades JL. A Feasible Estimation of a "Corrected" EQ-5D Social Tariff. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2024; 27:1243-1250. [PMID: 38795962 DOI: 10.1016/j.jval.2024.05.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/11/2023] [Revised: 04/25/2024] [Accepted: 05/07/2024] [Indexed: 05/28/2024]
Abstract
OBJECTIVES To demonstrate the feasibility of estimating a social tariff free of utility curvature and probability weighting biases and to test transferability between riskless and risky contexts. METHODS Valuations for a selection of EQ-5D-3L health states were collected from a large and representative sample (N = 1676) of the Spanish general population through computer-assisted personal interviewing. Two elicitation methods were used: the traditional time trade-off (TTO) and a novel risky-TTO procedure. Both methods are equivalent for better than death states, which allowed us to test transferability of utilities across riskless and risky contexts. Corrective procedures applied are based on rank-dependent utility theory, identifying parameter estimates at the individual level. All corrections are health-state specific, which is a unique feature of our corrective approach. RESULTS Two corrected value sets for the EQ-5D-3L system are estimated, highlighting the feasibility of developing national tariffs under nonexpected utility theories, such as rank-dependent utility. Furthermore, transferability was not supported for at least half of the health states valued by our sample. CONCLUSIONS It is feasible to estimate a social tariff by using interviewing techniques, sample sizes, and sample representativeness equivalent to prior studies designed to generate national value sets for the EQ-5D. Utilities obtained in distinct contexts may not be interchangeable. Our findings caution against routinely taking transferability of utility for granted.
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Affiliation(s)
- Jose-Maria Abellan-Perpiñan
- Applied Economics Department, Faculty of Economics and Business, University of Murcia, Murcia, Región de Murcia, Spain.
| | - Jorge-Eduardo Martinez-Perez
- Applied Economics Department, Faculty of Economics and Business, University of Murcia, Murcia, Región de Murcia, Spain
| | | | - Jose-Luis Pinto-Prades
- Department of Economics, School of Economics and Business, University of Navarra, Pamplona, Navarra, Spain
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Espirito Santo CM, Miyamoto GC, Santos VS, Ben ÂJ, Finch AP, Roudijk B, de Jesus-Moraleida FR, Stein AT, Santos M, Yamato TP. Estimating an EQ-5D-Y-3L Value Set for Brazil. PHARMACOECONOMICS 2024; 42:1047-1063. [PMID: 38954389 PMCID: PMC11343814 DOI: 10.1007/s40273-024-01404-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 05/27/2024] [Indexed: 07/04/2024]
Abstract
INTRODUCTION The EQ-5D-Y-3L is a generic measure of health-related quality of life in children and adolescents. Although the Brazilian-Portuguese EQ-5D-Y-3L version is available, there is no value set for it, hampering its use in economic evaluations. This study aimed to elicit a Brazilian EQ-5D-Y-3L value set based on preferences of the general adult population. METHODS Two independent samples of adults participated in an online discrete choice experiment (DCE) survey and a composite time trade-off (cTTO) face-to-face interview. The framing was "considering your views for a 10-year-old child". DCE data were analyzed using a mixed-logit model. The 243 DCE predicted values were mapped into the observed 28 cTTO values using linear and non-linear mapping approaches with and without intercept. Mapping approaches' performance was assessed to estimate the most valid method to rescale DCE predicted values using the model fit (R2), Akaike Information Criteria (AIC), root mean squared error (RMSE), and mean absolute error (MAE). RESULTS A representative sample of 1376 Brazilian adults participated (DCE, 1152; cTTO, 211). The linear mapping without intercept (R2 = 96%; AIC, - 44; RMSE, 0.0803; MAE, - 0.0479) outperformed the non-linear without intercept (R2 = 98%; AIC, - 63; RMSE, 0.1385; MAE, - 0.1320). Utilities ranged from 1 (full health) to - 0.0059 (the worst health state). Highest weights were assigned to having pain or discomfort (pain/discomfort), followed by walking about (mobility), looking after myself (self-care), doing usual activities (usual activities), and feeling worried, sad, or unhappy (anxiety/depression). CONCLUSION This study elicited the Brazilian EQ-5D-Y-3L value set using a mixed-logit DCE model with a power parameter based on a linear mapping without intercept, which can be used to estimate the quality-adjusted life-years for economic evaluations of health technologies targeting the Brazilian youth population.
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Affiliation(s)
- Caique Melo Espirito Santo
- Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuapé, São Paulo, 03071-000, Brazil
| | - Gisela Cristiane Miyamoto
- Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuapé, São Paulo, 03071-000, Brazil
| | - Verônica Souza Santos
- Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuapé, São Paulo, 03071-000, Brazil
| | - Ângela Jornada Ben
- Department of Health Sciences, Faculty of Science, Amsterdam Public Health Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
| | | | - Bram Roudijk
- EuroQol Research Foundation, Rotterdam, The Netherlands
| | | | - Airton Tetelbom Stein
- Department of Public Health, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
| | - Marisa Santos
- Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil
| | - Tiê Parma Yamato
- Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuapé, São Paulo, 03071-000, Brazil.
- Faculty of Medicine and Health, School of Health Sciences, The University of Sydney, Sydney, Australia.
- Nepean Blue Mountains Local Health District, Penrith, NSW, Australia.
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Yang Z, Rand K, Stolk E, Busschbach J, Luo N. Exploring non-iterative time trade-off methods for valuation of EQ-5D-5L health states. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2024; 25:1087-1094. [PMID: 38104294 DOI: 10.1007/s10198-023-01647-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/27/2023] [Accepted: 11/07/2023] [Indexed: 12/19/2023]
Abstract
INTRODUCTION The composite time trade-off (cTTO) method is used as the primary method for valuing EQ-5D-5L health states, but it requires intensive interviewer training and stringent quality control, which increases the burden of conducting cTTO studies. In this study, two non-iterative variants of the TTO method, non-stopping TTO (nTTO) and open-ended TTO (oTTO), were tested head-to-head with the cTTO method aiming to reduce the administration burden. METHODS 31 EQ-5D-5L health states from an orthogonal array was selected and valued by a general public sample in China. Data were collected by 7 interviewers with all interviewers performed an equal number of interviews using all three TTO methods. We compared the value distribution, logical consistency, administration burden, and modeling performance of these three TTO methods. RESULTS In total, 422 participants participated in the valuation interviews, with 139 using the nTTO method, 140 using the oTTO method, and 143 using the cTTO method. Both oTTO and nTTO methods saved around 10 min for conducting an interview. The mean values of three methods were similar with each method showed different characteristics in their value distributions. cTTO outperformed the other two methods in terms of modeling performance. DISCUSSION Both non-iterative TTO methods showed potential for valuing EQ-5D health states, although their data distributions and modeling performance were inferior to the cTTO method. The results of this study showed the potential of these two alternative non-iterative TTO methods.
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Affiliation(s)
- Zhihao Yang
- Department of Health Services Management, Guizhou Medical University, Guiyang, China
- Center of Medicine Economics and Management Research, Guizhou Medical University, Guiyang, China
| | - Kim Rand
- Health Services Research Centre, Akershus University Hospital, Lørenskog, Norway
- Maths in Health B.V, Rotterdam, The Netherlands
| | - Elly Stolk
- EuroQol Research Foundation, Rotterdam, The Netherlands
| | - Jan Busschbach
- Section of Medical Psychiatry and Psychotherapy, Erasmus Medical Centrum, Rotterdam, The Netherlands
| | - Nan Luo
- Saw Swee Hock School of Public Health, Tahir Foundation Building, National University of Singapore, 12 Science Drive 2, Singapore, Singapore.
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LaForce C, Albers FC, Cooper M, Danilewicz A, Dunsire L, Rees R, Cappelletti C. A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design. J Asthma Allergy 2024; 17:801-811. [PMID: 39193207 PMCID: PMC11348984 DOI: 10.2147/jaa.s471134] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Accepted: 07/31/2024] [Indexed: 08/29/2024] Open
Abstract
Purpose Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma. Methods BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥12 years using as-needed short-acting β2-agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol-budesonide 180/160 µg or albuterol 180 µg pMDI for up to 52 weeks (minimum 12 weeks). Participants continue their current maintenance therapy, if applicable. Participants must have used SABA for ≥2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥2 at screening and randomization. All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant's residence. The primary objective is to evaluate the efficacy of as-needed albuterol-budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint). Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure. Study medication use is captured via a Hailie sensor attached to the study medication pMDI. The intended sample size is 2500 participants. Conclusion BATURA evaluates as-needed albuterol-budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.
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Affiliation(s)
- Craig LaForce
- North Carolina Clinical Research, Chapel Hill, NC, USA
| | | | - Mark Cooper
- BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, UK
| | | | - Lynn Dunsire
- BioPharmaceuticals Research and Development, AstraZeneca, Cambridge, UK
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Chang JYA, Hsu CN, Ramos-Goñi JM, Luo N, Lin HW, Lin FJ. Beyond 10-year lead-times in EQ-5D-5L: leveraging alternative lead-times in willingness-to-accept questions to capture preferences for worse-than-dead states and their implication. THE EUROPEAN JOURNAL OF HEALTH ECONOMICS : HEPAC : HEALTH ECONOMICS IN PREVENTION AND CARE 2024; 25:1041-1055. [PMID: 38072877 DOI: 10.1007/s10198-023-01642-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/25/2023] [Accepted: 10/18/2023] [Indexed: 07/28/2024]
Abstract
BACKGROUND A fixed 10-year lead-time in composite time-trade-off (C-TTO) tasks might compromise the precision of utility values below - 1. This study explored how alternative lead-times (ALTs) influence EQ-5D-5L value sets and their implications in economic evaluations. METHODS Leveraging data from Taiwan's EQ-5D-5L valuation and capitalizing on its exploratory willingness-to-accept question, we explored participants' quantification of "worse-than-dead (WTD)" health states with ALTs up to 50 years. We then derived alternative value sets incorporating these ALTs through interval regression and compared them against those from conventional models. To evaluate their impact on health change valuation, we simulated utility differences for all possible EQ-5D-5L health-state-pairs using each value set. RESULTS With a salient floor effect observed in the C-TTO values, the model with ALT led to a wider range of predicted utilities ( - 2.3897 ~ 1), compared with those of conventional models (generalized least squares (GLS): - 0.7773 ~ 1; Tobit-GLS: - 0.9583 ~ 1). Compared to the Tobit-GLS model, the model with ALT increased the numerical distance in 80% of health-state-pairs, with 11% decreasing and 9% altering direction (e.g., positive to negative) in utility differences. CONCLUSIONS While ALTs offer insights into patient preferences, their integration into economic evaluations might require rescaling. Future research should prioritize advanced rescaling methods or enhanced elicitation strategies for populations with substantial censoring. This is pivotal for improving the elicitation of extreme WTD states and accurately discerning the relative distances between health states. Countries developing EQ-5D-5L value sets should consider pilot studies and incorporating region-specific questions on social determinants, especially where pronounced floor effects are suspected.
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Grants
- EQ project 2016440 EuroQol Research Foundation
- 10542652 The Center for Drug Evaluation, Taiwan
- NSC102-2320-B-039-007 Ministry of Science and Technology, Taiwan
- MOST 109-2622-8-039-001-TB1; MOST 110-2622-8-039-004 -TB1 Ministry of Science and Technology, Taiwan
- NHRI-EX103-10318PC The National Health Research Institute, Taiwan
- NHRI-EX104-10318PC The National Health Research Institute, Taiwan
- NHRI-EX105-10318PC The National Health Research Institute, Taiwan
- NHRI-EX106-10318PC The National Health Research Institute, Taiwan
- CMU108-N-03 China Medical University, Taiwan
- CMU108-Z-7 China Medical University, Taiwan
- CMU109-Z-07 China Medical University, Taiwan
- CMU110-Z-07 China Medical University, Taiwan
- DMR-110-080 China Medical University Hospital, Taiwan
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Affiliation(s)
- Jen-Yu Amy Chang
- School of Health and Related Research, University of Sheffield, Sheffield, UK
| | - Chien-Ning Hsu
- Department of Pharmacy, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
- School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan
| | | | - Nan Luo
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore
| | - Hsiang-Wen Lin
- School of Pharmacy and Graduate Institute, College of Pharmacy, China Medical University, Taichung, Taiwan.
- Department of Pharmacy, China Medical University Hospital, Taichung, Taiwan.
- Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, USA.
| | - Fang-Ju Lin
- Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
- School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
- Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.
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