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Article ; Online: The MOMANT study, a caregiver support programme with activities at home for people with dementia: a study protocol of a randomised controlled trial.

Balvert, S C E / Milders, M V / Bosmans, J E / Heymans, M W / van Bommel, S / Dröes, R-M / Scherder, E J A

2022 Volume 22, Issue 1, Page(s) 295

Abstract: Background: Because of the expected increase in the number of people with dementia, and the associated social and economic costs, there is an urgent need to develop effective and cost-effective care for people with dementia and their caregivers. The ... ...

Abstract	Background: Because of the expected increase in the number of people with dementia, and the associated social and economic costs, there is an urgent need to develop effective and cost-effective care for people with dementia and their caregivers. The intervention proposed here combines two approaches to caregiver support that have shown to be effective in empowering caregivers, i.e., multiple components for caregiver support and actively engaging caregivers to involve the person with dementia in activities at home. The aim is to investigate whether the intervention is effective in improving quality of life in the caregiver and the person with dementia. A further aim will be to investigate whether this intervention can improve caregivers' feeling of competence, experience of caregiving, and mood. Methods: The study design is a pragmatic, cluster randomised controlled trial with cost-effectiveness analysis. The study participants are informal caregivers and home-living persons with dementia for whom they care, recruited in various regions in the Netherlands. The trial will compare outcomes in two groups of participants: 85 dyads who receive the intervention, and 85 dyads who receive care as usual. The intervention is a caregiver support training that is manual based and consists of 6 group sessions over 2 months. Training takes place in small groups of caregivers led by a health care professional presented at dementia day care centres. Randomisation occurs at the level of the day care centre. Participants are assessed on the outcome measures at baseline, prior to the intervention, and at 3 and 6 months after baseline. Discussion: The study will provide insight into effectiveness and cost-effectiveness of an intervention that has not previously been evaluated or implemented in the Netherlands. The intervention potentially adds to the effective support options for informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals. Trial registration: The trial is registered at the Dutch Trial Register at NTR6643 August 22
MeSH term(s)	Activities of Daily Living ; Caregivers ; Cost-Benefit Analysis ; Dementia ; Humans ; Quality of Life ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2022-04-07
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2059865-8
ISSN	1471-2318 ; 1471-2318
ISSN (online)	1471-2318
ISSN	1471-2318
DOI	10.1186/s12877-022-02930-x
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Article ; Online: How healthy participants value additional diagnostic testing with amyloid-PET in patients diagnosed with mild cognitive impairment - a bidding game experiment.

van Maurik, I S / Bakker, E D / van Unnik, A A J M / Broulikova, H M / Zwan, M D / van de Giessen, E / Berkhof, J / Bouwman, F H / Bosmans, J E / van der Flier, W M

Alzheimer's research & therapy

2023 Volume 15, Issue 1, Page(s) 208

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 ... ...

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.
MeSH term(s)	Female ; Humans ; Male ; Alzheimer Disease/diagnosis ; Amyloid ; Amyloid beta-Peptides ; Amyloidogenic Proteins ; Cognitive Dysfunction/diagnostic imaging ; Diagnostic Techniques and Procedures ; Healthy Volunteers ; Positron-Emission Tomography/methods ; Sensitivity and Specificity ; Middle Aged ; Aged
Chemical Substances	Amyloid ; Amyloid beta-Peptides ; Amyloidogenic Proteins
Language	English
Publishing date	2023-11-28
Publishing country	England
Document type	Randomized Controlled Trial ; Video-Audio Media ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2506521-X
ISSN	1758-9193 ; 1758-9193
ISSN (online)	1758-9193
ISSN	1758-9193
DOI	10.1186/s13195-023-01346-y
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Article ; Online: 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.

Schotanus, A Y / Dozeman, E / Ikelaar, S L C / van Straten, A / Beekman, A T F / van Nassau, F / Bosmans, J E / van Schaik, A

BMC psychiatry

2023 Volume 23, Issue 1, Page(s) 75

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 ... ...

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
MeSH term(s)	Humans ; Ambulatory Care Facilities ; Cognitive Behavioral Therapy/methods ; Depressive Disorder, Major/complications ; Depressive Disorder, Major/therapy ; Quality of Life ; Randomized Controlled Trials as Topic ; Sleep Initiation and Maintenance Disorders/complications ; Sleep Initiation and Maintenance Disorders/therapy ; Treatment Outcome ; Internet-Based Intervention
Language	English
Publishing date	2023-01-27
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2050438-X
ISSN	1471-244X ; 1471-244X
ISSN (online)	1471-244X
ISSN	1471-244X
DOI	10.1186/s12888-022-04492-z
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Article ; Online: Cost-effectiveness of selective decontamination of the digestive tract to decrease infectious complications in colorectal cancer surgery: An analysis of the SELECT trial.

Reuvers, J R D / Gaikhorst, E / Ben, Â Jornada / Scholten, J / van Egmond, M / Bosmans, J E / Stockmann, H B A C / Kazemier, G / Tuynman, J B / Abis, G S A / Oosterling, S J

European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology

2023 Volume 49, Issue 12, Page(s) 107116

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 ... ...

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.
MeSH term(s)	Humans ; Anti-Bacterial Agents/therapeutic use ; Cost-Benefit Analysis ; Decontamination ; Postoperative Complications/epidemiology ; Postoperative Complications/prevention & control ; Colorectal Neoplasms/surgery ; Colorectal Neoplasms/drug therapy
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-10-27
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ZDB-ID	632519-1
ISSN	1532-2157 ; 0748-7983
ISSN (online)	1532-2157
ISSN	0748-7983
DOI	10.1016/j.ejso.2023.107116
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Article ; Online: Cost-effectiveness of a stepped care program to prevent depression among primary care patients with diabetes mellitus type 2 and/or coronary heart disease and subthreshold depression in comparison with usual care.

van Dijk, S E M / Pols, A D / Adriaanse, M C / van Marwijk, H W J / van Tulder, M W / Bosmans, J E

BMC psychiatry

2021 Volume 21, Issue 1, Page(s) 402

Abstract: Background: Patients with diabetes mellitus type 2 (DM2) and/or coronary heart disease (CHD) are at high risk to develop major depression. Preventing incident major depression may be an important tool in reducing the personal and societal burden of ... ...

Abstract	Background: Patients with diabetes mellitus type 2 (DM2) and/or coronary heart disease (CHD) are at high risk to develop major depression. Preventing incident major depression may be an important tool in reducing the personal and societal burden of depression. The aim of the current study was to assess the cost-effectiveness of a stepped care program to prevent major depression (Step-Dep) in diabetes mellitus type 2 and/or coronary heart disease patients with subthreshold depression in comparison with usual care. Methods: An economic evaluation with 12 months follow-up was conducted alongside a pragmatic cluster-randomized controlled trial from a societal perspective. Participants received care as usual (n = 140) or Step-Dep (n = 96) which consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to a general practitioner. Primary outcomes were quality-adjusted life years (QALYs) and cumulative incidence of major depression. Costs were measured every 3 months. Missing data was imputed using multiple imputation. Uncertainty around cost-effectiveness outcomes was estimated using bootstrapping and presented in cost-effectiveness planes and acceptability curves. Results: There were no significant differences in QALYs or depression incidence between treatment groups. Secondary care costs (mean difference €1644, 95% CI €344; €3370) and informal care costs (mean difference €1930, 95% CI €528; €4089) were significantly higher in the Step-Dep group than in the usual care group. The difference in total societal costs (€1001, 95% CI €-3975; €6409) was not statistically significant. The probability of the Step-Dep intervention being cost-effective was low, with a maximum of 0.41 at a ceiling ratio of €30,000 per QALY gained and 0.32 at a ceiling ratio of €0 per prevented case of major depression. Conclusions: The Step-Dep intervention is not cost-effective compared to usual care in a population of patients with DM2/CHD and subthreshold depression. Therefore, widespread implementation cannot be recommended. Trial registration: The trial was registered in the Netherlands Trial Register ( NTR3715 ).
MeSH term(s)	Coronary Disease/complications ; Coronary Disease/prevention & control ; Cost-Benefit Analysis ; Depression/prevention & control ; Depressive Disorder, Major ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/therapy ; Humans ; Primary Health Care ; Quality-Adjusted Life Years
Language	English
Publishing date	2021-08-13
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1471-244X
ISSN (online)	1471-244X
DOI	10.1186/s12888-021-03367-z
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Article ; Online: Diabetes prevalence, diabetes regimen and co-morbidity in depressed patients compared with non-depressed patients in primary care in the Netherlands.

Adriaanse, M C / Bosmans, J E

Diabetic medicine : a journal of the British Diabetic Association

2010 Volume 27, Issue 6, Page(s) 718–722

Abstract: Aims: To assess the prevalence of diabetes in depressed patients compared with non-depressed matched controls and to compare diabetes regimen and co-morbidity in depressed patients with diabetes vs. non-depressed patients with diabetes in primary care ... ...

Abstract	Aims: To assess the prevalence of diabetes in depressed patients compared with non-depressed matched controls and to compare diabetes regimen and co-morbidity in depressed patients with diabetes vs. non-depressed patients with diabetes in primary care in the Netherlands. Methods: A retrospective case-control study over 3 years (2002-2004). Data for depressed patients (n = 7128) and non-depressed matched controls (n = 23,772) were available from an electronic medical record system of 20 general practices organized in one large primary care organization in the Netherlands. Matching was based on year and month of birth, sex and general practitioner. Diabetes, diabetes regimen (i.e. oral glucose medication, insulin or both) and co-morbidity were defined using Anatomical Therapeutic Chemical classification codes of delivered medication. Results: The prevalence of diabetes was 5.5% (n = 393) among depressed patients, which was 2.6 times higher than in non-depressed matched controls where the figure was 2.1% (n = 494; P < 0.001). Diabetes regimen, i.e. the proportions of subjects on oral glucose medication, insulin or both did not differ among depressed patients with diabetes (51, 27 and 22%, respectively) compared with non-depressed patients with diabetes (51, 30, 19%; P = 0.53). Co-morbidity was significantly more prevalent among depressed patient with diabetes than in non-depressed patients with diabetes. Conclusions: Compared with non-depressed matched controls, adults with treated depression have almost three times higher rates of diabetes. Depressed patients with diabetes had more co-morbidities compared with non-depressed patients with diabetes, whereas diabetes regimen did not differ.
MeSH term(s)	Adult ; Aged ; Case-Control Studies ; Comorbidity ; Depressive Disorder/complications ; Depressive Disorder/psychology ; Diabetes Mellitus/drug therapy ; Diabetes Mellitus/psychology ; Electronic Health Records ; Female ; Humans ; Hypoglycemic Agents/therapeutic use ; Male ; Middle Aged ; Netherlands ; Prevalence ; Primary Health Care ; Retrospective Studies ; Statistics as Topic
Chemical Substances	Hypoglycemic Agents
Language	English
Publishing date	2010-06
Publishing country	England
Document type	Journal Article
ZDB-ID	605769-x
ISSN	1464-5491 ; 0742-3071 ; 1466-5468
ISSN (online)	1464-5491
ISSN	0742-3071 ; 1466-5468
DOI	10.1111/j.1464-5491.2010.03002.x
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Article ; Online: Cost-effectiveness of home-based vs. in-hospital treatment of paediatric tuberculous meningitis.

van Elsland, S L / van Dongen, S I / Bosmans, J E / Schaaf, H S / van Toorn, R / van Furth, A M

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease

2018 Volume 22, Issue 10, Page(s) 1188–1195

Abstract: Setting: Cape Town, South Africa, 2014.: Objective: To assess the societal costs and cost-effectiveness of home-based vs. in-hospital treatment of paediatric tuberculous meningitis.: Design: This was an economic evaluation from a societal ... ...

Abstract	Setting: Cape Town, South Africa, 2014. Objective: To assess the societal costs and cost-effectiveness of home-based vs. in-hospital treatment of paediatric tuberculous meningitis. Design: This was an economic evaluation from a societal perspective using probabilistic analysis. Health care, informal care, lost productivity costs and costs in other sectors, health-related quality of life (HRQoL) and family impact were assessed during interviews with care givers, children, medical staff and management. Results: Societal costs for home-based treatment were USD3857, and USD28 043 for in-hospital treatment. Home-based vs. in-hospital treatment HRQoL scores were 90.9% vs. 84.5%, while family impact scores were 94.8% vs. 73.1%. The point estimate of the incremental cost-effectiveness ratio indicated that improving HRQoL and family impact by 1% was associated with a saving of respectively USD3726 and USD1140 for home-based vs. in-hospital treatment. The probability that home-based treatment was less expensive and more effective than in-hospital treatment was 96.3% for HRQoL and 100% for family impact. Conclusion: Societal costs of home-based treatment were lower than for in-hospital treatment. Children treated at home had a better HRQoL and family impact scores. Home-based treatment was a cost-effective alternative to in-hospital treatment of drug-susceptible tuberculous meningitis.
MeSH term(s)	Child ; Child, Preschool ; Cost-Benefit Analysis ; Female ; Health Care Costs/statistics & numerical data ; Home Care Services/economics ; Hospitalization/economics ; Humans ; Infant ; Male ; Quality of Life ; South Africa ; Tuberculosis, Meningeal/economics ; Tuberculosis, Meningeal/therapy
Language	English
Publishing date	2018-09-20
Publishing country	France
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1385624-8
ISSN	1815-7920 ; 1027-3719
ISSN (online)	1815-7920
ISSN	1027-3719
DOI	10.5588/ijtld.18.0236
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Article ; Online: Quality of life in a broader perspective: Does ASCOT reflect the capability approach?

van Loon, M S / van Leeuwen, K M / Ostelo, R W J G / Bosmans, J E / Widdershoven, G A M

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

2017 Volume 27, Issue 5, Page(s) 1181–1189

Abstract: Purpose: Economic evaluation of services and interventions in care services tends to focus on quality of life(QoL) based on health-related measures such as EQ5D, with a major focus on health and functioning. The Capability Approach (CA) provides an ... ...

Abstract	Purpose: Economic evaluation of services and interventions in care services tends to focus on quality of life(QoL) based on health-related measures such as EQ5D, with a major focus on health and functioning. The Capability Approach (CA) provides an alternative framework for measuring QoL and challenges some of the conventional issues in the current practice of measurement of QoL. The Adult Social Care Outcomes Toolkit (ASCOT) aims to measure social care-related QoL in a broad sense. This article investigates whether and, if so, how the ASCOT addresses issues put on the agenda by the CA. Methods: Literature analysis concerning theoretical assumptions and arguments of CA and ASCOT. Results: The Capability Approach (CA) puts three issues on the agenda regarding QoL. First, the focus of evaluation should not be on functioning, but on freedom of choice. Second, evaluation should be critical about adaptive preferences, which entail that people lower expectations in situations of limited possibilities. Third, evaluation should not only address health, but also other domains of life. Our analysis shows that freedom of choice is reflected in the response option 'as I want' in the ASCOT questionnaire. The problem of adaptive preferences is countered in the ASCOT by developing a standard based on preferences of the general population. Third, the ASCOT contains several domains of life. Conclusions: We conclude that the CA and the ASCOT contribute to the discussion on QoL, and that the ASCOT operationalizes core assumptions of the CA, translating the issues raised by the CA in a practical way.
MeSH term(s)	Aged ; Choice Behavior ; Cost-Benefit Analysis/methods ; Female ; Health Status ; Humans ; Male ; Quality of Life/psychology ; Surveys and Questionnaires
Language	English
Publishing date	2017-12-14
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1161148-0
ISSN	1573-2649 ; 0962-9343
ISSN (online)	1573-2649
ISSN	0962-9343
DOI	10.1007/s11136-017-1756-5
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Article ; Online: Safe shortening of antibiotic treatment duration for complicated

BMJ open

2023 Volume 13, Issue 4, Page(s) e068295

Abstract: Introduction: A major knowledge gap in the treatment of complicated : 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 ... ...

Abstract	Introduction: A major knowledge gap in the treatment of complicated 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).
MeSH term(s)	Adult ; Humans ; Anti-Bacterial Agents ; Staphylococcal Infections/drug therapy ; Staphylococcal Infections/microbiology ; Bacteremia/microbiology ; Duration of Therapy ; Staphylococcus aureus ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-04-21
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-068295
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Article ; Online: Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

de Wit, M / Rondags, S M P A / van Tulder, M W / Snoek, F J / Bosmans, J E

Diabetic medicine : a journal of the British Diabetic Association

2017 Volume 35, Issue 2, Page(s) 214–222

Abstract: Aims: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes ... ...

Abstract	Aims: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. Methods: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). Results: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. Conclusions: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).
MeSH term(s)	Cluster Analysis ; Cost-Benefit Analysis ; Diabetes Mellitus, Type 1/economics ; Diabetes Mellitus, Type 1/therapy ; Diabetes Mellitus, Type 2/economics ; Diabetes Mellitus, Type 2/therapy ; Female ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemia/economics ; Hypoglycemia/prevention & control ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/economics ; Insulin/adverse effects ; Insulin/economics ; Internet/economics ; Internet/statistics & numerical data ; Male ; Middle Aged ; Patient Education as Topic/economics ; Patient Education as Topic/methods ; Psychotherapy, Group/methods ; Treatment Outcome
Chemical Substances	Hypoglycemic Agents ; Insulin
Language	English
Publishing date	2017-12-12
Publishing country	England
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605769-x
ISSN	1464-5491 ; 0742-3071 ; 1466-5468
ISSN (online)	1464-5491
ISSN	0742-3071 ; 1466-5468
DOI	10.1111/dme.13548
Database	MEDical Literature Analysis and Retrieval System OnLINE

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