245 results on '"Bosmans JE"'
Search Results
2. Safe shortening of antibiotic treatment duration for complicatedStaphylococcus aureusbacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment
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Buis, DTP, primary, van Werkhoven, CH, additional, van Agtmael, MA, additional, Bax, HI, additional, Berrevoets, M, additional, de Boer, MGJ, additional, Bonten, MJM, additional, Bosmans, JE, additional, Branger, J, additional, Douiyeb, S, additional, Gelinck, LBS, additional, Jong, E, additional, Lammers, AJJ, additional, Van der Meer, JTM, additional, Oosterheert, JJ, additional, Sieswerda, E, additional, Soetekouw, R, additional, Stalenhoef, JE, additional, Van der Vaart, TW, additional, Bij de Vaate, EA, additional, Verkaik, NJ, additional, Van Vonderen, MGA, additional, De Vries, PJ, additional, Prins, JM, additional, and Sigaloff, KCE, additional
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- 2023
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3. Bias? Clarifying the language barrier between epidemiologists and economists
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Varga, AN, primary, Guevara Morel, AE, additional, van Dongen, JM, additional, Lokkerbol, J, additional, Lindeboom, M, additional, van Tulder, MW, additional, Bouter, LM, additional, and Bosmans, JE, additional
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- 2022
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4. PRM202 - COMPARING THE EQ-5D-5L CROSSWALKS AND VALUE SETS FOR ENGLAND, THE NETHERLANDS AND SPAIN: DO CONCLUSIONS CHANGE?
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Ben, Â, primary, Finch, AP, additional, van Dongen, J.M., additional, Wit, Md, additional, van Dijk, S.E., additional, Adriaanse, MC, additional, Snoek, FJ, additional, van Tulder, M.W., additional, and Bosmans, JE, additional
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- 2018
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5. Cost-Effectiveness of Guided Internet-Based Treatments for Depression In Comparison With Control Conditions: An Individual-Participant Data Meta-Analysis
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Kolovos, S, primary, van Dongen, JM, additional, Riper, H, additional, van Tulder, MW, additional, and Bosmans, JE, additional
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- 2017
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6. Quality Of Reporting And Analysis Of Trial-Based Cost Efectiveness Evaluations In Obstetrics And Gynaecology; A Systematic Review
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El Alili, M, primary, van Dongen, JM, additional, Huirne, J, additional, van Tulder, MW, additional, and Bosmans, JE, additional
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- 2017
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7. Investigating the Effects of Testing and Adjusting for Nonlinearity using Categorization in Prediction Models with Costs as Outcome
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Brouwers, DB, primary, Nieboer, D, additional, Bosmans, JE, additional, van Tulder, MW, additional, Heymans, MW, additional, and van Dongen, JM, additional
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- 2016
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8. The Impact of Country-Specific Utility Tariffs on the Outcome of Cost-Utility Analyses; A Case Study
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Bosmans, JE, primary, Rossenaar, MM, additional, van Dongen, JM, additional, and van Tulder, MW, additional
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- 2016
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9. Use of Economic Evaluations of Health Technologies In Dutch Healthcare Decision-Making: Barriers And Facilitators
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Roseboom, KJ, primary, van Dongen, JM, additional, Tompa, E, additional, van Tulder, MW, additional, and Bosmans, JE, additional
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- 2015
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10. Cost-Effectiveness of Manual Therapy Versus Physical Therapy In Patients With Sub-Acute and Chronic Neck Pain: A Randomized Controlled Trial
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van Dongen, JM, primary, Groeneweg, R, additional, Rubinstein, SM, additional, Bosmans, JE, additional, Oostendorp, RA, additional, Ostelo, RW, additional, and van Tulder, MW, additional
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- 2015
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11. MH1 - Discrete Event Simulation Modelling of Long Term Cost-Effectiveness of Internet-Based Blended Cognitive Behavioural Therapy for Major Depressive Disorder: Extrapolation of the E-Compared Randomised Controlled Trial
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O'Connell, MM, Kolovos, S, Bosmans, JE, Forbes, JF, and E-COMPARED Consortium
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- 2017
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12. PRM213 - Quality Of Reporting And Analysis Of Trial-Based Cost Efectiveness Evaluations In Obstetrics And Gynaecology; A Systematic Review
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El Alili, M, van Dongen, JM, Huirne, J, van Tulder, MW, and Bosmans, JE
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- 2017
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13. PMH34 - Cost-Effectiveness of Guided Internet-Based Treatments for Depression In Comparison With Control Conditions: An Individual-Participant Data Meta-Analysis
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Kolovos, S, van Dongen, JM, Riper, H, van Tulder, MW, and Bosmans, JE
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- 2017
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14. PRM160 - The Impact of Country-Specific Utility Tariffs on the Outcome of Cost-Utility Analyses; A Case Study
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Bosmans, JE, Rossenaar, MM, van Dongen, JM, and van Tulder, MW
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- 2016
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15. PRM129 - Investigating the Effects of Testing and Adjusting for Nonlinearity using Categorization in Prediction Models with Costs as Outcome
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Brouwers, DB, Nieboer, D, Bosmans, JE, van Tulder, MW, Heymans, MW, and van Dongen, JM
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- 2016
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16. Potential Savings of a Program to Prevent Ankle Sprain Recurrence: Economic Evaluation of a Randomized Controlled Trial Maarten.
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Hupperets MDW, Verhagen EALM, Heymans MW, Bosmans JE, van Tulder MW, and van Mechelen W
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- 2010
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17. PHP149 - Use of Economic Evaluations of Health Technologies In Dutch Healthcare Decision-Making: Barriers And Facilitators
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Roseboom, KJ, van Dongen, JM, Tompa, E, van Tulder, MW, and Bosmans, JE
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- 2015
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18. PSY63 - Cost-Effectiveness of Manual Therapy Versus Physical Therapy In Patients With Sub-Acute and Chronic Neck Pain: A Randomized Controlled Trial
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van Dongen, JM, Groeneweg, R, Rubinstein, SM, Bosmans, JE, Oostendorp, RA, Ostelo, RW, and van Tulder, MW
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- 2015
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19. PSY63 Cost-Effectiveness of Manual Therapy Versus Physical Therapy In Patients With Sub-Acute and Chronic Neck Pain: A Randomized Controlled Trial
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van Dongen, JM, Groeneweg, R, Rubinstein, SM, Bosmans, JE, Oostendorp, RA, Ostelo, RW, and van Tulder, MW
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20. PHP149 Use of Economic Evaluations of Health Technologies In Dutch Healthcare Decision-Making: Barriers And Facilitators
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Roseboom, KJ, van Dongen, JM, Tompa, E, van Tulder, MW, and Bosmans, JE
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21. Fibromuscular dysplasia presenting as a renal infarction: a case report
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Verpooten Gert A, Ichiche Malika, Van Hul Erik, Van den Driessche Annelies, and Bosmans Jean-Louis
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Medicine - Abstract
Abstract Introduction Fibromuscular dysplasia is a non-atherosclerotic, non-inflammatory disease that most commonly affects the renal and internal carotid arteries. Case presentation We present the case of a 44-year-old Caucasian man who was admitted with complaints of loin pain and hypertension. A computed tomography scan of the abdomen revealed a right renal infarction with a nodular aspect of the right renal artery. Subsequent renal angiography revealed a typical 'string of beads' pattern of the right renal artery with thrombus formation. Oral anticoagulation was started and the secondary hypertension was easily controlled with anti-hypertensive drugs. At follow-up, our patient refused percutaneous transluminal renal angioplasty as a definitive treatment. Conclusions Fibromuscular dysplasia is the most common cause of renovascular hypertension in patients under 50 years of age. Presentation with renal infarction is rare. In fibromuscular dysplasia, angioplasty has been proven to have, at least for some indications, an advantage over anti-hypertensive drugs. Therefore, hypertension secondary to fibromuscular dysplasia is the most common cause of curable hypertension.
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- 2010
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22. Is behavioral graded activity cost-effective in comparison with manual therapy for patients with subacute neck pain?: an economic evaluation alongside a randomized clinical trial.
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Bosmans JE, Pool JJ, de Vet HC, van Tulder MW, and Ostelo RW
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STUDY DESIGN.: An economic evaluation alongside a randomized controlled trial comparing behavioral graded activity (BGA) with manual therapy (MT). OBJECTIVE.: To evaluate the cost-effectiveness of BGA in comparison with MT for patients with subacute neck pain from a societal perspective. SUMMARY OF BACKGROUND DATA.: Neck pain is common and poses an important socioeconomic burden to society. Data on the cost-effectiveness of treatments for neck pain are scarce. METHODS.: A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. MT consists of specific spinal mobilization techniques and exercises. Clinical outcomes included recovery, pain, disability, and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using cost diaries. The follow-up period was 52 weeks. Multiple imputation was used for missing cost and effect data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability (CEA) curves were estimated. RESULTS.: BGA had no significant effect on recovery or QALYs gained in comparison with MT but pain and disability did improve significantly in the BGA group in comparison with the MT group. Total societal costs in the BGA group were nonsignificantly higher than in the MT group. Cost-effectiveness analyses showed that BGA is not cost-effective in comparison with MT for recovery and QALYs gained. Substantial investments are needed to reach a 0.95 probability that BGA is cost-effective in comparison with MT for pain and disability. CONCLUSION.: On the basis of the data presented, we consider BGA not cost-effective in comparison with MT. [ABSTRACT FROM AUTHOR]
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- 2011
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23. Cost-effectiveness of tailored print communication, telephone motivational interviewing, and a combination of the two: results of an economic evaluation alongside the Vitalum randomized controlled trial [corrected] [published erratum appears in INT J BEHAV NUTR PHYS ACT 2011;8:2p].
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van Keulen HM, Bosmans JE, van Tulder MW, Severens JL, de Vries H, Brug J, and Mesters I
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- 2010
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24. Economic evaluation of donepezil in moderate to severe Alzheimer disease.
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van Hout HPJ, Bosmans JE, Stalman WAB, Feldman H, Hux M, Schwam EM, van Hout, Hein P J, Bosmans, Judith E, and Stalman, Wim A B
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- 2005
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25. The interplay between costs, quality, and organisation of home care in Europe
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van Lier, Lisanne Irene, van Hout, Hein, van der Roest, Henriëtte, Bosmans, JE, APH - Aging & Later Life, General practice, van der Roest, Henriëtte Geralde, and Bosmans, Judith E.
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benchmarking analyses,societal costs ,predictiemodel ,maatschappelijke kosten ,kwaliteit van zorg ,aanbevelingen kostenonderzoek ,thuiszorg ,benchmarking analyses ,Europe ,prediction model ,costing recommendations ,quality of care ,ouderen ,thuiszorgmodellen ,models of home care delivery ,Europa ,home care ,societal costs ,older adults - Abstract
Health and long-term care systems in Europe are under pressure, as a shrinking labour force may no longer be able to provide for the needs of the growing number of older people living at home. The research described in this thesis was part of the ‘Identifying best practices for care-dependent elderly by Benchmarking Costs and outcomes of Community Care’ (IBenC) project which was funded within the 7th Framework Program of the European Commission. The aim of the IBenC project was to develop a new benchmark methodology based on quality of care and cost of care utilisation to identify best practices in home care. Best practices that are able to produce good outcomes with limited resource use may make long-term care systems more sustainable. In this thesis, we developed consensus-based recommendations for the identification, measurement and valuation of healthcare utilisation and lost productivity that are applicable for cross-European economic evaluations. In addition, we showed that the interRAI-HC, a comprehensive geriatric assessment instrument that is widely used in routine care for care planning, can be validly used to estimate societal costs next to quality of care outcomes. This substantially improves the feasibility of performing economic evaluations among older home care clients, since there is no need to burden them with additional assessments. Next, we identified potentially modifiable (ADL and iADL impairment, limitations of going out because of fear of falling, oral problems, caregiver distress, presence of pain, urinary incontinence) and non-modifiable predictors (country of residence, living status, cognitive impairment, arthritis, history of a Cerebrovascular Accident, health instability, behavioural problems, multimorbidity, and number of prescribed medications) of societal costs generated by older home care clients across European countries. We showed that specific characteristics of home care models (patient-centred care; availability of specialised care professionals, level of monitoring of care performance) are related to societal costs. Further, we developed a novel method to benchmark home care organisations on two case-mix adjusted quality of care summary scales and healthcare costs. Last, internationally applicable benchmarks like the one we present in this thesis can provide information on the performance of home care within and across countries and regions with regard to both quality of care and costs.
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- 2021
26. Cost-effectiveness of general practitioner- versus surgeon-led colon cancer survivorship care: an economic evaluation alongside a randomised controlled trial.
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Vos JAM, El Alili M, Duineveld LAM, Wieldraaijer T, Wind J, Sert E, Donkervoort SC, Govaert MJPM, van Geloven NAW, van de Ven AWH, Heuff G, van Weert HCPM, Bosmans JE, and van Asselt KM
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- Humans, Male, Female, Middle Aged, Aged, Surgeons economics, Survivorship, Health Care Costs, Quality-Adjusted Life Years, Cost-Benefit Analysis, General Practitioners, Colonic Neoplasms economics, Colonic Neoplasms mortality, Colonic Neoplasms therapy, Cancer Survivors, Quality of Life
- Abstract
Purpose: The aim of this study is to assess cost-effectiveness of general practitioner (GP) versus surgeon-led colon cancer survivorship care from a societal perspective., Methods: We performed an economic evaluation alongside the I CARE study, which included 303 cancer patients (stages I-III) who were randomised to survivorship care by a GP or surgeon. Questionnaires were administered at baseline, 3-, 6-, 12-, 24- and 36-months. Costs included healthcare costs (measured by iMTA MCQ) and lost productivity costs (SF-HLQ). Disease-specific quality of life (QoL) was measured using EORTC QLQ-C30 summary score and general QoL using EQ-5D-3L quality-adjusted life years (QALYs). Missing data were imputed. Incremental cost-effectiveness ratios (ICERs) were calculated to relate costs to effects on QoL. Statistical uncertainty was estimated using bootstrapping., Results: Total societal costs of GP-led care were significantly lower compared to surgeon-led care (mean difference of - €3895; 95% CI - €6113; - €1712). Lost productivity was the main contributor to the difference in societal costs (- €3305; 95% CI - €5028; - €1739). The difference in QLQ-C30 summary score over time between groups was 1.33 (95% CI - 0.049; 3.15). The ICER for QLQ-C30 was - 2073, indicating that GP-led care is dominant over surgeon-led care. The difference in QALYs was - 0.021 (95% CI - 0.083; 0.040) resulting in an ICER of 129,164., Conclusions: GP-led care is likely to be cost-effective for disease-specific QoL, but not for general QoL., Implications for Cancer Survivors: With a growing number of cancer survivors, GP-led survivorship care could help to alleviate some of the burden on more expensive secondary healthcare services., (© 2023. The Author(s).)
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- 2024
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27. Subjective household poverty as a moderator for the association between employment precariousness and mental health across five european welfare state types.
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Pauls C, Fleischmann M, Klein M, Bouwhuis S, and Bosmans JE
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Objectives: To create better understanding of the mechanisms underlying the association between employment precariousness (EP) and mental health by considering household poverty as a moderator while stratifying for gender across welfare state types (WSTs): Scandinavian, South European, Central- and East European, Bismarckian and Anglo-Saxon., Methods: Data from the sixth wave of the European Working Conditions Survey (N = 18,725) was used. The Employment Precariousness Scale was used to assess EP on a continuous scale. Mental health was measured using the WHO-5 Well-Being Index. A binary variable for subjective household poverty was created. We estimated gender-stratified, multi-level models with a random intercept at country-level for the association between EP and mental health, with an interaction term between EP and subjective household poverty, for each WST separately. Models were adjusted for age, education, having a partner and having children under age 18 in the household., Results: In all WSTs, among men as well as women, we found a negative relation between EP and mental health. Among women, this relation was not moderated by household poverty. Among men in the Anglo-Saxon WST, the negative relation between EP and mental health was stronger among employees that reported household poverty compared to those who did not report household poverty., Conclusions: Evidence of a moderating effect of household poverty on the association between EP and mental health was only found amongst men in the Anglo-Saxon WSTs and the combined full sample. Other factors that might affect the association between EP and mental health should be investigated., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
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- 2024
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28. Antenatal cardiotocography in primary midwife-led care: a budget impact analysis.
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Neppelenbroek E, Jornada Ben Â, Nij Bijvank BSWA, Bosmans JE, Groenen CJM, Jonge A, and Verhoeven CJM
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- Humans, Female, Netherlands, Pregnancy, Adult, Prospective Studies, Prenatal Care statistics & numerical data, Prenatal Care economics, Prenatal Care methods, Midwifery statistics & numerical data, Midwifery economics, Midwifery methods, Cardiotocography methods, Cardiotocography statistics & numerical data, Cardiotocography economics, Cardiotocography standards, Budgets statistics & numerical data, Budgets methods
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Objectives: In many countries, the healthcare sector is dealing with important challenges such as increased demand for healthcare services, capacity problems in hospitals and rising healthcare costs. Therefore, one of the aims of the Dutch government is to move care from in-hospital to out-of-hospital care settings. An example of an innovation where care is moved from a more specialised setting to a less specialised setting is the performance of an antenatal cardiotocography (aCTG) in primary midwife-led care. The aim of this study was to assess the budget impact of implementing aCTG for healthy pregnant women in midwife-led care compared with usual obstetrician-led care in the Netherlands., Methods: A budget impact analysis was conducted to estimate the actual costs and reimbursement of aCTG performed in midwife-led care and obstetrician-led care (ie, base-case analysis) from the Dutch healthcare perspective. Epidemiological and healthcare utilisation data describing both care pathways were obtained from a prospective cohort, survey and national databases. Different implementation rates of aCTG in midwife-led care were explored. A probabilistic sensitivity analysis was conducted to estimate the uncertainty surrounding the budget impact estimates., Results: Shifting aCTG from obstetrician-led care to midwife-led-care would increase actual costs with €311 763 (97.5% CI €188 574 to €426 072) and €1 247 052 (97.5% CI €754 296 to €1 704 290) for implementation rates of 25% and 100%, respectively, while it would decrease reimbursement with -€7 538 335 (97.5% CI -€10 302 306 to -€4 559 661) and -€30 153 342 (97.5% CI -€41 209 225 to -€18 238 645) for implementation rates of 25% and 100%, respectively. The sensitivity analysis results were consistent with those of the main analysis., Conclusions: From the Dutch healthcare perspective, we estimated that implementing aCTG in midwife-led care may increase the associated actual costs. At the same time, it might lower the healthcare reimbursement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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29. Cost-effectiveness of the FindMyApps eHealth intervention vs. digital care as usual: results from a randomised controlled trial.
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Neal DP, Kucera M, van Munster BC, Ettema TP, Dijkstra K, Muller M, Dröes RM, and Bosmans JE
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Objectives: Despite growing interest, the cost-effectiveness of eHealth interventions for supporting quality of life of people with dementia and their caregivers remains unclear. This study evaluated the cost-effectiveness of the FindMyApps intervention, compared to digital care-as-usual. FindMyApps aims to help people with dementia and their caregivers find and learn to use tablet apps that may support social participation and self-management of people with dementia and sense of competence of caregivers., Method: A randomised controlled trial (Netherlands Trial Register NL8157) was conducted, including people with mild cognitive impairment (MCI) or mild dementia and their informal caregivers (FindMyApps n = 76, digital care-as-usual n = 74). Outcomes for people with MCI/dementia were Quality-Adjusted Life-Years (QALYs), calculated from EQ-5D-5L data and the Dutch tariff for utility scores, social participation (Maastricht Social Participation Profile) and quality of life (Adult Social Care Outcomes Toolkit), and for caregivers, QALYs and sense of competence (Short Sense of Competence Questionnaire). Societal costs were calculated using data collected with the RUD-lite instrument and the Dutch costing guideline. Multiple imputation was employed to fill in missing cost and effect data. Bootstrapped multilevel models were used to estimate incremental total societal costs and incremental effects between groups which were then used to calculate Incremental Cost-Effectiveness Ratios (ICERs). Cost-effectiveness acceptability curves were estimated., Results: In the FindMyApps group, caregiver SSCQ scores were significantly higher compared to care-as-usual , n = 150, mean difference = 0.75, 95% CI [0.14, 1.38]. Other outcomes did not significantly differ between groups. Total societal costs for people with dementia were not significantly different, n = 150, mean difference = €-774, 95%CI [-2.643, .,079]. Total societal costs for caregivers were significantly lower in the FindMyApps group compared to care-as-usual, n = 150, mean difference = € -392, 95% CI [-1.254, -26], largely due to lower supportive care costs, mean difference = €-252, 95% CI [-1.009, 42]. For all outcomes, the probability that FindMyApps was cost-effective at a willingness-to-pay threshold of €0 per point of improvement was 0.72 for people with dementia and 0.93 for caregivers., Conclusion: FindMyApps is a cost-effective intervention for supporting caregivers' sense of competence. Further implementation of FindMyApps is warranted.
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- 2024
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30. Costs of care trajectories of people with dementia compared with matched controls. Longitudinal analysis of linked health and administrative data.
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Bosmans JE, van der Heide I, van Hout HPJ, and Joling KJ
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- Humans, Male, Female, Aged, Longitudinal Studies, Aged, 80 and over, Case-Control Studies, Home Care Services economics, Home Care Services statistics & numerical data, Electronic Health Records statistics & numerical data, Institutionalization economics, Institutionalization statistics & numerical data, Middle Aged, Long-Term Care economics, Long-Term Care statistics & numerical data, Dementia economics, Dementia therapy, Health Care Costs statistics & numerical data
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Objectives: To provide insight into the health and social care costs during the disease trajectory in persons with dementia and the impact of institutionalization and death on healthcare costs compared with matched persons without dementia., Methods: Electronic health record data from family physicians were linked with national administrative databases to estimate costs of primary care, medication, secondary care, mental care, home care and institutional care for people with dementia and matched persons from the year before the recorded dementia diagnosis until death or a maximum of 4 years after the diagnosis., Results: Total mean health and social care costs among persons with dementia increased substantially during the disease trajectory, mainly due to institutional care costs. For people who remained living in the community, mean health and social care costs are higher for people with dementia than for those without dementia, while for those who are admitted to a long-term care facility, mean health and social care costs are higher for people without dementia than for those with dementia., Conclusions: The steep rise in health and social care costs across the dementia care trajectory is mainly due to increasing costs for institutional care. For those remaining in the community, home care costs and hospital care costs were the main cost drivers. Future research should adopt a societal perspective to investigate the influence of including social costs., (© 2024 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd.)
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- 2024
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31. Cost-effectiveness of behavioral activation compared to treatment as usual for depressed older adults in primary care: A cluster randomized controlled trial.
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Janssen NP, Hendriks GJ, Sens R, Lucassen P, Oude Voshaar RC, Ekers D, van Marwijk H, Spijker J, and Bosmans JE
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- Humans, Aged, Cost-Benefit Analysis, Behavior Therapy, Quality-Adjusted Life Years, Primary Health Care, Quality of Life, Cognitive Behavioral Therapy methods
- Abstract
Introduction: Depression in older adults is associated with decreased quality of life and increased utilization of healthcare services. Behavioral activation (BA) is an effective treatment for late-life depression, but the cost-effectiveness compared to treatment as usual (TAU) is unknown., Methods: An economic evaluation was performed alongside a cluster randomized controlled multicenter trial including 161 older adults (≥65 years) with moderate to severe depressive symptoms (PHQ-9 ≥ 10). Outcome measures were depression (response on the QIDS-SR), quality-adjusted life-years (QALYs) and societal costs. Missing data were imputed using multiple imputation. Cost and effect differences were estimated using bivariate linear regression models, and statistical uncertainty was estimated with bootstrapping. Cost-effectiveness acceptability curves showed the probability of cost-effectiveness at different ceiling ratios., Results: Societal costs were statistically non-significantly lower in BA compared to TAU (mean difference (MD) -€485, 95 % CI -3861 to 2792). There were no significant differences in response on the QIDS-SR (MD 0.085, 95 % CI -0.015 to 0.19), and QALYs (MD 0.026, 95 % CI -0.0037 to 0.055). On average, BA was dominant over TAU (i.e., more effective and less expensive), although the probability of dominance was only 0.60 from the societal perspective and 0.85 from the health care perspective for both QIDS-SR response and QALYs., Discussion: Although the results suggest that BA is dominant over TAU, there was considerable uncertainty surrounding the cost-effectiveness estimates which precludes firm conclusions., Competing Interests: Declaration of competing interest GJH occasionally receives honoraria for lectures at symposia. On a yearly basis it is never more than €1000. DE is Chief investigator for UK NIHR funded multimorbidity in older adults program of research. A program in a similar clinical area looking at BA in people 65 and over with 2 or more health problems and depression. HvM was supported by the National Institute of Health Research (NIHR) Applied Health Collaboration Kent, Surrey, Sussex. The views expressed are those of the author(s) and not necessarily the NHS, the NIHR or the Department of Health and Social Care. All other authors declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
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- 2024
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32. Optimizing and Implementing a Community-Based Group Fall Prevention Program: A Mixed Methods Study.
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van Gameren M, Voorn PB, Bosmans JE, Visser B, Frazer SWT, Pijnappels M, and Bossen D
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- Humans, Aged, Focus Groups, Costs and Cost Analysis, Netherlands, Accidental Falls prevention & control
- Abstract
Falls and fall-related injuries among older adults are associated with decreased health. Therefore, fall prevention programs (FPPs) are increasingly important. However, the translation of such complex programs into clinical practice lacks insight into factors that influence implementation. Therefore, the aim of this study was to identify how to optimize and further implement a widely used group-based FPP in the Netherlands among participants, therapists and stakeholders using a mixed methods study. FPP participants and therapists filled out a questionnaire about their experiences with the FPP. Moreover, three focus groups were conducted with FPP participants, one with therapists and one with other stakeholders. Data were analysed according to the thematic analysis approach of Braun and Clarke. Overall, 93% of the 104 FPP participants were satisfied with the FPP and 86% (n = 12) of the therapists would recommend the FPP to older adults with balance or mobility difficulties. Moreover, six themes were identified regarding further implementation: (1) recruiting and motivating older adults to participate; (2) structure and content of the program; (3) awareness, confidence and physical effects; (4) training with peers; (5) funding and costs; and (6) long-term continuation. This study resulted in practical recommendations for optimizing and further implementing FPPs in practice.
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- 2024
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33. Don't be late! Postponing cognitive decline and preventing early unemployment in people with multiple sclerosis: a study protocol.
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Aarts J, Saddal SRD, Bosmans JE, de Groot V, de Jong BA, Klein M, Ruitenberg MFL, Schaafsma FG, Schippers ECF, Schoonheim MM, Uitdehaag BMJ, van der Veen S, Waskowiak PT, Widdershoven GAM, van der Hiele K, and Hulst HE
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- Humans, Quality of Life, Unemployment, Exercise, Randomized Controlled Trials as Topic, Multiple Sclerosis complications, Multiple Sclerosis therapy, Cognitive Dysfunction prevention & control
- Abstract
Background: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS., Aims: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL)., Methods: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) 'strengthening the brain' - a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) 'strengthening the mind' - a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group-receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don't be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions., Discussion: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice., Trial Registration: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023., (© 2024. The Author(s).)
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- 2024
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34. Cost-effectiveness of selective decontamination of the digestive tract to decrease infectious complications in colorectal cancer surgery: An analysis of the SELECT trial.
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Reuvers JRD, Gaikhorst E, Ben ÂJ, Scholten J, van Egmond M, Bosmans JE, Stockmann HBAC, Kazemier G, Tuynman JB, Abis GSA, and Oosterling SJ
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- Humans, Cost-Benefit Analysis, Decontamination, Postoperative Complications epidemiology, Postoperative Complications prevention & control, Anti-Bacterial Agents therapeutic use, Colorectal Neoplasms surgery, Colorectal Neoplasms drug therapy
- Abstract
Introduction: Selective decontamination of the digestive tract (SDD) is effective in reducing infectious complications in elective colorectal cancer (CRC) surgery. However, it is unclear whether SDD is cost-effective compared to standard antibiotic prophylaxis., Material & Methods: Economic evaluation alongside multicenter randomized controlled trial, the SELECT-trial, from a healthcare perspective. Patients included underwent elective surgery for non-metastatic CRC. The intervention group received oral non-absorbable colistin, tobramycin and amphotericin B (SDD) next to standard antibiotic prophylaxis. Both groups received a single shot intravenous cefazolin and metronidazole preoperatively as standard prophylaxis. Occurrence of postoperative infectious complication in the first 30 postoperative days was extracted from medical records, Quality-Adjusted Life-Years (QALYs) based on the ED-5D-3L, and healthcare costs collected from the hospital's financial administration., Results: Of the 455 patients, 228 were randomly assigned to intervention group and 227 patients to the control group. SDD significantly reduced the number of infectious complications compared to control (difference = -0.13, 95 % CI -0.05 to -0.20). No difference was found for QALYs (difference = 0.002, 95 % CI -0.002 to 0.005). Healthcare costs were statistically significantly lower in the intervention group (difference = -€1258, 95 % CI -2751 to -166). The ICER was -9872 €/infectious complication prevented and -820,380 €/QALY gained. For all willingness-to-pay thresholds, the probability that prophylactic SDD was cost-effective compared to standard prophylactic practice alone was 1.0., Conclusion: The addition of SDD to the standard preoperative intravenous antibiotic prophylaxis is cost-effective compared to standard prophylactic practice from a healthcare perspective and should be considered as the standard of care., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 Published by Elsevier Ltd.)
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- 2023
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35. How healthy participants value additional diagnostic testing with amyloid-PET in patients diagnosed with mild cognitive impairment - a bidding game experiment.
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van Maurik IS, Bakker ED, van Unnik AAJM, Broulikova HM, Zwan MD, van de Giessen E, Berkhof J, Bouwman FH, Bosmans JE, and van der Flier WM
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- Female, Humans, Male, Amyloid, Amyloid beta-Peptides, Amyloidogenic Proteins, Diagnostic Techniques and Procedures, Healthy Volunteers, Positron-Emission Tomography methods, Sensitivity and Specificity, Middle Aged, Aged, Alzheimer Disease diagnosis, Cognitive Dysfunction diagnostic imaging
- Abstract
Background: To estimate the perceived value of additional testing with amyloid-PET in Euros in healthy participants acting as analogue patients with mild cognitive impairment (MCI)., Methods: One thousand four hundred thirty-one healthy participants acting as analogue MCI patients (mean age 65 ± 8, 929 (75%) female) were recruited via the Dutch Brain Research Registry. Participants were asked to identify with a presented case (video vignette) of an MCI patient and asked whether they would prefer additional diagnostic testing with amyloid PET in this situation. If yes, respondents were asked how much they would be willing to pay for additional diagnostic testing. Monetary value was elicited via a bidding game in which participants were randomized over three conditions: (A) additional testing results in better patient management, (B) Same as condition A and a delay in institutionalization of 3 months, and (C) same as A and a delay in institutionalization of 6 months. Participants who were not willing to take a test were compared with participants who were willing to take a test using logit models. The highest monetary value per condition was analyzed using random-parameter mixed models., Results: The vast majority of participants acting as analogue MCI patients (87% (n = 1238)) preferred additional testing with amyloid PET. Participants who were not interested were more often female (OR = 1.61 95% CI [1.09-2.40]) and expressed fewer worries to get AD (OR = 0.64 [0.47-0.87]). The median "a priori" (i.e., before randomization) monetary value of additional diagnostic testing was €1500 (IQR 500-1500). If an additional amyloid PET resulted in better patient management (not further specified; condition A), participants were willing to pay a median price of €2000 (IQR = 1000-3500). Participants were willing to pay significantly more than condition A (better patient management) if amyloid-PET testing additionally resulted in a delay in institutionalization of 3 months (€530 [255-805] on top of €2000, condition B) or 6 months (€596 [187-1005] on top of €2000, condition C)., Conclusions: Members of the general population acting as MCI patients are willing to pay a substantial amount of money for amyloid-PET and this increases when diagnostic testing leads to better patient management and the prospect to live longer at home., (© 2023. The Author(s).)
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- 2023
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36. To what extent does the use of crosswalks instead of EQ-5D value sets impact reimbursement decisions?: a simulation study.
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Ben ÂJ, van Dongen JM, Finch AP, Alili ME, and Bosmans JE
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- Humans, Health Status, Quality of Life, Surveys and Questionnaires, Psychometrics, Reproducibility of Results, Osteoarthritis, Neoplasms
- Abstract
Purpose: Inconsistent results have been found on the impact of using crosswalks versus EQ-5D value sets on reimbursement decisions. We sought to further investigate this issue in a simulation study., Methods: Trial-based economic evaluation data were simulated for different conditions (depression, low back pain, osteoarthritis, cancer), severity levels (mild, moderate, severe), and effect sizes (small, medium, large). For all 36 scenarios, utilities were calculated using 3L and 5L value sets and crosswalks (3L to 5L and 5L to 3L crosswalks) for the Netherlands, the United States, and Japan. Utilities, quality-adjusted life years (QALYs), incremental QALYs, incremental cost-effectiveness ratios (ICERs), and probabilities of cost-effectiveness (pCE) obtained from values sets and crosswalks were compared., Results: Differences between value sets and crosswalks ranged from -0.33 to 0.13 for utilities, from -0.18 to 0.13 for QALYs, and from -0.01 to 0.08 for incremental QALYs, resulting in different ICERs. For small effect sizes, at a willingness-to-pay of €20,000/QALY, the largest pCE difference was found for moderate cancer between the Japanese 5L value set and 5L to 3L crosswalk (difference = 0.63). For medium effect sizes, the largest difference was found for mild cancer between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.06). For large effect sizes, the largest difference was found for mild osteoarthritis between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.08)., Conclusion: The use of crosswalks instead of EQ-5D value sets can impact cost-utility outcomes to such an extent that this may influence reimbursement decisions., (© 2022. The Author(s).)
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- 2023
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37. Conducting Trial-Based Economic Evaluations Using R: A Tutorial.
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Ben ÂJ, van Dongen JM, El Alili M, Esser JL, Broulíková HM, and Bosmans JE
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Trial-based economic evaluations are increasingly being conducted to support healthcare decision-making. When analysing trial-based economic evaluation data, different methodological challenges may be encountered, including (i) missing data, (ii) correlated costs and effects, (iii) baseline imbalances and (iv) skewness of costs and/or effects. Despite the broad range of methods available to account for these methodological challenges in effectiveness studies, they may not always be directly applicable in trial-based economic evaluations where costs and effects are analysed jointly, and more than one methodological challenge typically needs to be addressed simultaneously. The use of inappropriate methods can bias results and conclusions regarding the cost-effectiveness of healthcare interventions. Eventually, such low-quality evidence can hamper healthcare decision-making, which may in turn result in a waste of already scarce healthcare resources. Therefore, this tutorial aims to provide step-by-step guidance on how to combine appropriate statistical methods for handling the abovementioned methodological challenges using a ready-to-use R script. The theoretical background of the described methods is provided, and their application is illustrated using a simulated trial-based economic evaluation., (© 2023. The Author(s).)
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- 2023
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38. Cost-effectiveness of twice-weekly versus once-weekly sessions of cognitive-behavioural therapy and interpersonal psychotherapy for depression at 12 months after start of treatment: randomised controlled trial.
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Bosmans JE, Bruijniks SJE, El Alili M, Hollon SD, Peeters FPML, Arntz A, Cuijpers P, Lemmens LHJM, Dingemanse P, Willems L, van Oppen P, van den Boogaard M, Spijker J, Twisk JWR, and Huibers MJH
- Abstract
Background: Cost-effective treatments are needed to reduce the burden of depression. One way to improve the cost-effectiveness of psychotherapy might be to increase session frequency, but keep the total number of sessions constant., Aim: To evaluate the cost-effectiveness of twice-weekly compared with once-weekly psychotherapy sessions after 12 months, from a societal perspective., Method: An economic evaluation was conducted alongside a randomised controlled trial comparing twice-weekly versus once-weekly sessions of psychotherapy (cognitive-behavioural therapy or interpersonal psychotherapy) for depression. Missing data were handled by multiple imputation. Statistical uncertainty was estimated with bootstrapping and presented with cost-effectiveness acceptability curves., Results: Differences between the two groups in depressive symptoms, physical and social functioning, and quality-adjusted life-years (QALY) at 12-month follow-up were small and not statistically significant. Total societal costs in the twice-weekly session group were higher, albeit not statistically significantly so, than in the once-weekly session group (mean difference €2065, 95% CI -686 to 5146). The probability that twice-weekly sessions are cost-effective compared with once-weekly sessions was 0.40 at a ceiling ratio of €1000 per point improvement in Beck Depression Inventory-II score, 0.32 at a ceiling ratio of €50 000 per QALY gained, 0.23 at a ceiling ratio of €1000 per point improvement in physical functioning score and 0.62 at a ceiling ratio of €1000 per point improvement in social functioning score., Conclusions: Based on the current results, twice-weekly sessions of psychotherapy for depression are not cost-effective over the long term compared with once-weekly sessions.
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- 2023
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39. Effects of a clinical decision support system and patient portal for preventing medication-related falls in older fallers: Protocol of a cluster randomized controlled trial with embedded process and economic evaluations (ADFICE_IT).
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de Wildt KK, van de Loo B, Linn AJ, Medlock SK, Groos SS, Ploegmakers KJ, Seppala LJ, Bosmans JE, Abu-Hanna A, van Weert JCM, van Schoor NM, and van der Velde N
- Subjects
- Humans, Aged, Cost-Benefit Analysis, Accidental Falls prevention & control, Quality of Life, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Decision Support Systems, Clinical, Patient Portals
- Abstract
Background: Falls are the leading cause of injury-related mortality and hospitalization among adults aged ≥ 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs., Methods: A multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged ≥ 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patient's consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression., Discussion: The findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries., Trial Registration: ClinicalTrials.gov NCT05449470 (7-7-2022)., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 de Wildt et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2023
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40. Healthcare costs of different treatment options for condylar fractures.
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Helmer LML, Dubois L, Lobbezoo F, de Lange J, and Bosmans JE
- Abstract
Objective: As treatment options for condylar fractures have comparable outcomes, getting insight into associated costs is a first step towards implementing value-based healthcare (VBH). Therefore, we described the actual costs of the different treatment options (surgical, conservative, and expectative treatment) for condylar fractures. We expected surgical treatment to be the most expensive treatment., Study Design: This is a cost-of-illness study, based on estimates from the literature. Firstly, care pathways of all treatment options were described. Secondly, the costs per step were calculated based on the literature and Dutch guidelines for economic evaluations in health care., Results: The direct treatment costs of surgical treatment (€3721 to €4040) are three to five times higher than conservative treatment (€730 to €1332). When lost productivity costs during the recovery period are included, costs of surgical treatment remain 1.5 times higher (€9511 to €9830 for surgical treatment and €6224 to €6826 for conservative treatment). The costs of expectative treatment (€5436) are lower than both other treatments., Conclusion: The costs for surgical treatment are considerably higher than those for conservative or expectative treatment, mainly related to direct treatment cost. Future research should focus on the patients' perspective, to support implementation of VBH in treating condylar fractures., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)
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- 2023
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41. The handling of missing data in trial-based economic evaluations: should data be multiply imputed prior to longitudinal linear mixed-model analyses?
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Ben ÂJ, van Dongen JM, Alili ME, Heymans MW, Twisk JWR, MacNeil-Vroomen JL, de Wit M, van Dijk SEM, Oosterhuis T, and Bosmans JE
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- Humans, Linear Models, Computer Simulation, Cost-Benefit Analysis
- Abstract
Introduction: For the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data., Methods: Two-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10, 25, and 50% missing data in follow-up costs and effects, assuming a Missing At Random (MAR) mechanism. Six different strategies were compared using empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). These strategies were: LLM alone (LLM) and MI with LLM (MI-LLM), and, as reference strategies, mean imputation with LLM (M-LLM), seemingly unrelated regression alone (SUR-CCA), MI with SUR (MI-SUR), and mean imputation with SUR (M-SUR)., Results: For costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, SUR-CCA, and M-SUR, with smaller EBs and RMSEs as well as CRs closers to nominal levels. However, even though LLM, MI-LLM and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 and 25% missing data. At 50% missing data, all strategies resulted in relatively high EBs and RMSEs for costs., Conclusion: LLM should be combined with MI when analyzing trial-based economic evaluation data. MI-SUR is more efficient and can also be used, but then an average intervention effect over time cannot be estimated., (© 2022. The Author(s).)
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- 2023
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42. Effectiveness and Cost-effectiveness of Minimal Ovarian Stimulation in-vitro Fertilization versus Conventional Ovarian Stimulation in Poor Responders: Economic Evaluation Alongside a Propensity Score Adjusted Prospective Observational Study.
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Souza TO, Ben ÂJ, Dongen JMV, Bosmans JE, and Cunha-Filho JSLD
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- Pregnancy, Female, Humans, Cost-Benefit Analysis, Propensity Score, Ovulation Induction, Fertilization, Birth Rate, Fertilization in Vitro
- Abstract
Objective: Information on the pregnancy rate after successive in-vitro fertilization (IVF) cycles and their associated costs is relevant for couples undergoing assisted reproduction treatments (ARTs). This study, therefore, sought to investigate the effectiveness and the cost-effectiveness of two ARTs, the minimal ovarian stimulation IVF (MS-IVF) compared to the conventional ovarian stimulation IVF (C-IVF) from the payer's perspective., Methods: A 10-months follow-up prospective observational study was conducted in a sample of couples who sought ARTs in a private clinic in Southern Brazil. Women had to satisfy the Bologna Criteria and be older than 35 years. The effect outcome was pregnancy rate per initiated cycle. Medication costs were based on medical records. Costs and effect differences were estimated using seemingly unrelated regressions adjusted for the propensity score estimated based on women's characteristics., Results: All 84 eligible women who agreed to participate received a total of 92 IVF cycles (MS-IVF, n=27[35 cycles]; C-IVF n=57[57 cycles]. The effect difference between MS-IVF and C-IVF was -5.1% (95%CI, -13.2 to 5.2). Medication costs of MS-IVF were significantly lower than C-IVF by €-1260 (95%CI, -1401 to -1118). The probabilities of MS-IVF being cost-effective compared to C-IVF ranged from 1 to 0.76 for willingness-to-pay of €0 to €15,000 per established pregnancy, respectively., Conclusions: Even though there were no positive effect differences between groups, MS-IVF might be cost-effective compared to C-IVF from the payer's perspective due to its relatively large cost savings compared to C-IVF. However, further investigation is needed to confirm these findings in a larger sample.
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- 2023
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43. Correction: Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): a pragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy.
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Kool M, Van HL, Bartak A, de Maat SCM, Arntz A, van den Eshof JW, Peen J, Blankers M, Bosmans JE, and Dekker JJM
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- 2023
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44. Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?
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Ben ÂJ, Pellekooren S, Bosmans JE, Ostelo RWJG, Maas ET, El Alili M, van Tulder MW, Huygen FJPM, Oosterhuis T, Apeldoorn AT, van Hooff ML, and van Dongen JM
- Subjects
- Humans, Surveys and Questionnaires, Logistic Models, Cost-Benefit Analysis, Algorithms, Quality of Life, Low Back Pain diagnosis
- Abstract
Objectives: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models., Methods: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R
2 ), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations., Results: The Non-p performed the best (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR)., Conclusions: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations., (Copyright © 2023. Published by Elsevier Inc.)- Published
- 2023
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45. Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority trial comparing 4 and 6 weeks of antibiotic treatment.
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Buis D, van Werkhoven CH, van Agtmael MA, Bax HI, Berrevoets M, de Boer M, Bonten M, Bosmans JE, Branger J, Douiyeb S, Gelinck L, Jong E, Lammers A, Van der Meer J, Oosterheert JJ, Sieswerda E, Soetekouw R, Stalenhoef JE, Van der Vaart TW, Bij de Vaate EA, Verkaik NJ, Van Vonderen M, De Vries PJ, Prins JM, and Sigaloff K
- Subjects
- Adult, Humans, Anti-Bacterial Agents, Duration of Therapy, Staphylococcus aureus, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Staphylococcal Infections drug therapy, Staphylococcal Infections microbiology, Bacteremia microbiology
- Abstract
Introduction: A major knowledge gap in the treatment of complicated Staphylococcus aureus bacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of hospital stay and costs. The objective of the SAFE trial is to evaluate whether 4 weeks of antibiotic therapy is non-inferior to 6 weeks in patients with complicated SAB., Methods and Analysis: The SAFE-trial is a multicentre, non-inferiority, open-label, parallel group, randomised controlled trial evaluating 4 versus 6 weeks of antibiotic therapy for complicated SAB. The study is performed in 15 university hospitals and general hospitals in the Netherlands. Eligible patients are adults with methicillin-susceptible SAB with evidence of deep-seated or metastatic infection and/or predictors of complicated SAB. Only patients with a satisfactory clinical response to initial antibiotic treatment are included. Patients with infected prosthetic material or an undrained abscess of 5 cm or more at day 14 of adequate antibiotic treatment are excluded. Primary outcome is success of therapy after 180 days, a combined endpoint of survival without evidence of microbiologically confirmed disease relapse. Assuming a primary endpoint occurrence of 90% in the 6 weeks group, a non-inferiority margin of 7.5% is used. Enrolment of 396 patients in total is required to demonstrate non-inferiority of shorter antibiotic therapy with a power of 80%. Currently, 152 patients are enrolled in the study., Ethics and Dissemination: This is the first randomised controlled trial evaluating duration of antibiotic therapy for complicated SAB. Non-inferiority of 4 weeks of treatment would allow shortening of treatment duration in selected patients with complicated SAB. This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). Results of the study will be published in a peer-reviewed journal., Trial Registration Number: NL8347 (the Netherlands Trial Register)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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46. Dealing with confounding in observational studies: A scoping review of methods evaluated in simulation studies with single-point exposure.
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Varga AN, Guevara Morel AE, Lokkerbol J, van Dongen JM, van Tulder MW, and Bosmans JE
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- Humans, Computer Simulation, Bias, Research
- Abstract
The aim of this article was to perform a scoping review of methods available for dealing with confounding when analyzing the effect of health care treatments with single-point exposure in observational data. We aim to provide an overview of methods and their performance assessed by simulation studies indexed in PubMed. We searched PubMed for simulation studies published until January 2021. Our search was restricted to studies evaluating binary treatments and binary and/or continuous outcomes. Information was extracted on the methods' assumptions, performance, and technical properties. Of 28,548 identified references, 127 studies were eligible for inclusion. Of them, 84 assessed 14 different methods (ie, groups of estimators that share assumptions and implementation) for dealing with measured confounding, and 43 assessed 10 different methods for dealing with unmeasured confounding. Results suggest that there are large differences in performance between methods and that the performance of a specific method is highly dependent on the estimator. Furthermore, the methods' assumptions regarding the specific data features also substantially influence the methods' performance. Finally, the methods result in different estimands (ie, target of inference), which can even vary within methods. In conclusion, when choosing a method to adjust for measured or unmeasured confounding it is important to choose the most appropriate estimand, while considering the population of interest, data structure, and whether the plausibility of the methods' required assumptions hold., (© 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.)
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- 2023
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47. Internet-delivered cognitive behavioural therapy for insomnia disorder in depressed patients treated at an outpatient clinic for mood disorders: protocol of a randomised controlled trial.
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Schotanus AY, Dozeman E, Ikelaar SLC, van Straten A, Beekman ATF, van Nassau F, Bosmans JE, and van Schaik A
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- Humans, Ambulatory Care Facilities, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome, Cognitive Behavioral Therapy methods, Depressive Disorder, Major complications, Depressive Disorder, Major therapy, Sleep Initiation and Maintenance Disorders complications, Sleep Initiation and Maintenance Disorders therapy, Internet-Based Intervention
- Abstract
Background: Major depression is a highly prevalent disorder causing severe personal distress, and high societal costs. Patients with depression often have comorbid insomnia disorder (ID) leading to even worse personal distress and worse treatment outcomes. Recent results from a non-randomised pilot study with internet-delivered Cognitive Behavioural Therapy (CBTi) for Insomnia (I-Sleep) added to regular depression care were promising regarding feasibility and initial effects on insomnia complaints and depression. However, no randomised controlled trial (RCT) has been performed yet to access the (cost-) effectiveness of I-Sleep for depression. Therefore, this protocol article presents the design of an RCT aimed to assess the (cost-) effectiveness of I-Sleep in addition to usual care for depression compared to usual care alone in depressed patients with a comorbid Insomnia Disorder (ID) treated at outpatient clinics for mood disorders. METHODS /DESIGN: This is a multi-centre RCT with measurements at baseline and at 3, 6, 9, and 12 months of follow-up. Patients with depression and an ID are randomised to either I-Sleep treatment followed by regular depression care or to regular depression care alone. Our aim is to recruit one hundred and seventy-five patients from multiple outpatient clinics for mood disorders. The primary outcome is the change in depressive symptoms over 12 months of follow-up measured with the Patient Health Questionnaire (PHQ-9). Secondary outcomes are recovery from depression (PHQ-9), insomnia severity (Insomnia Severity Index, ISI), daily functioning (Work and Social Adjustment Scale, WSAS), general quality of life (EuroQol 5-level version, EQ-5D-5L), and societal costs (Adapted versions of the iMTA Productivity Cost Questionnaire, iPCQ and iMTA Medical Cost Questionnaire, iMCQ)., Discussion: We hypothesize that the addition of I-Sleep to usual care will result in a significant improvement in depression treatment outcomes and quality of life as well as a decrease in healthcare and societal costs compared to usual care alone. This study is the first pragmatic RCT evaluating the effectiveness and cost-effectiveness of adding CBTi to usual care for depression., Trial Registration: Netherlands Trial Register (NL8955). Registered on October 6
th 2020. https://trialsearch.who.int/Trial2.aspx?TrialID=NL8955., (© 2023. The Author(s).)- Published
- 2023
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48. Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial.
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Janssen NP, Lucassen P, Huibers MJH, Ekers D, Broekman T, Bosmans JE, Van Marwijk H, Spijker J, Oude Voshaar R, and Hendriks GJ
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- Humans, Aged, Treatment Outcome, Self Report, Primary Health Care, Cost-Benefit Analysis, Depression psychology, Cognitive Behavioral Therapy
- Abstract
Introduction: Effective non-pharmacological treatment options for depression in older adults are lacking., Objective: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated., Methods: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up., Results: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = -2.77, 95% CI = -4.19 to -1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42-1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = -1.53, 95% CI = -2.81 to -0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07-0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = -0.89 (-2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = -0.82 to 0.24)., Conclusions: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up., (© 2023 The Author(s). Published by S. Karger AG, Basel.)
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- 2023
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49. A scoping review of statistical methods for trial-based economic evaluations: The current state of play.
- Author
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El Alili M, van Dongen JM, Esser JL, Heymans MW, van Tulder MW, and Bosmans JE
- Subjects
- Humans, Cost-Benefit Analysis
- Abstract
The statistical quality of trial-based economic evaluations is often suboptimal, while a comprehensive overview of available statistical methods is lacking. Therefore, this review summarized and critically appraised available statistical methods for trial-based economic evaluations. A literature search was performed to identify studies on statistical methods for dealing with baseline imbalances, skewed costs and/or effects, correlated costs and effects, clustered data, longitudinal data, missing data and censoring in trial-based economic evaluations. Data was extracted on the statistical methods described, their advantages, disadvantages, relative performance and recommendations of the study. Sixty-eight studies were included. Of them, 27 (40%) assessed methods for baseline imbalances, 39 (57%) assessed methods for skewed costs and/or effects, 27 (40%) assessed methods for correlated costs and effects, 18 (26%) assessed methods for clustered data, 7 (10%) assessed methods for longitudinal data, 26 (38%) assessed methods for missing data and 10 (15%) assessed methods for censoring. All identified methods were narratively described. This review provides a comprehensive overview of available statistical methods for dealing with the most common statistical complexities in trial-based economic evaluations. Herewith, it can provide valuable input for researchers when deciding which statistical methods to use in a trial-based economic evaluation., (© 2022 The Authors. Health Economics published by John Wiley & Sons Ltd.)
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- 2022
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50. Cost-effectiveness and return-on-investment of C-reactive protein point-of-care testing in comparison with usual care to reduce antibiotic prescribing for lower respiratory tract infections in nursing homes: a cluster randomised trial.
- Author
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Boere TM, El Alili M, van Buul LW, Hopstaken RM, Verheij TJM, Hertogh CMPM, van Tulder MW, and Bosmans JE
- Subjects
- Anti-Bacterial Agents therapeutic use, Cost-Benefit Analysis, Humans, Nursing Homes, Point-of-Care Testing, Practice Patterns, Physicians', C-Reactive Protein, Respiratory Tract Infections diagnosis, Respiratory Tract Infections drug therapy
- Abstract
Objectives: C-reactive protein point-of-care testing (CRP POCT) is a promising diagnostic tool to guide antibiotic prescribing for lower respiratory tract infections (LRTI) in nursing home residents. This study aimed to evaluate cost-effectiveness and return-on-investment (ROI) of CRP POCT compared with usual care for nursing home residents with suspected LRTI from a healthcare perspective., Design: Economic evaluation alongside a cluster randomised, controlled trial., Setting: 11 Dutch nursing homes., Participants: 241 nursing home residents with a newly suspected LRTI., Intervention: Nursing home access to CRP POCT (POCT-guided care) was compared with usual care without CRP POCT (usual care)., Main Outcome Measures: The primary outcome measure for the cost-effectiveness analysis was antibiotic prescribing at initial consultation, and the secondary outcome was full recovery at 3 weeks. ROI analyses included intervention costs, and benefits related to antibiotic prescribing. Three ROI metrics were calculated: Net Benefits, Benefit-Cost-Ratio and Return-On-Investment., Results: In POCT-guided care, total costs were on average €32 higher per patient, the proportion of avoided antibiotic prescribing was higher (0.47 vs 0.18; 0.30, 95% CI 0.17 to 0.42) and the proportion of fully recovered patients statistically non-significantly lower (0.86 vs 0.91; -0.05, 95% CI -0.14 to 0.05) compared with usual care. On average, an avoided antibiotic prescription was associated with an investment of €137 in POCT-guided care compared with usual care. Sensitivity analyses showed that results were relatively robust. Taking the ROI metrics together, the probability of financial return was 0.65., Conclusion: POCT-guided care effectively reduces antibiotic prescribing compared with usual care without significant effects on recovery rates, but requires an investment. Future studies should take into account potential beneficial effects of POCT-guided care on costs and health outcomes related to antibiotic resistance., Trial Registration Number: NL5054., Competing Interests: Competing interests: The authors declare: LWvB, TMB, MEA, JB and CMPMH report a grant from The Netherlands Organisation for Health Research and Development (ZonMw), for the conduct of the current study. RH receives no support from any organisation for the submitted work. MWvT reports grants from The Netherlands Organisation for Health Research and Development (ZonMw), outside the submitted work. TJMV reports grants from Abbott, Becton Dickinson, Biomerieux, European Commission; grants from European Commission, Orion, during the conduct of the study; grants from European Commission, Janssen Pharmaceuticals; and grants from ZonMw, outside the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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