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1.
Injury ; 54(10): 110913, 2023 Oct.
Article En | MEDLINE | ID: mdl-37536004

BACKGROUND: The incidence of Lisfranc fractures is rising, along with the incidence of foot fractures in general. These injuries can lead to long-term healthcare use and societal costs. Current economic evaluation studies are scarce in Lisfranc fracture research, and only investigate the healthcare costs. The aim of the present study was to accurately measure the monetary societal burden of disease and quality of life in the first 6 months after the injury in patients with Lisfranc fractures in the Netherlands. MATERIALS AND METHODS: This study used a prevalence-based, bottom-up approach. Patients were included through thirteen medical centres in the Netherlands. Both stable and unstable injuries were included. The societal perspective was used. The costs were measured at baseline, 12 weeks and 6 months using the iMTA MCQ and PCQ questionnaires. Reference prices were used for valuation. Quality-of-life was measured using the EQ-5D-5 L and VAS scores. RESULTS: 214 patients were included. The mean age was 45.9 years, and 24.3% of patients had comorbidities. The baseline questionnaires yielded approximately €2023 as the total societal costs in the 3 months prior to injury. The follow-up questionnaires and surgery costs assessment yielded approximately €17,083 as the total costs in the first 6 months after injury. Of these costs, approximately two thirds could be attributed to productivity losses. The EQ-5D-5 L found a mean index value of 0.449 at baseline and an index value of 0.737 at the 6-month follow-up. CONCLUSION: The total monetary societal costs in the first 6 months after injury are approximately €17,083. Approximately two thirds of these costs can be attributed to productivity losses. These costs appear to be somewhat higher than those found in other studies. However, these studies only included the healthcare costs. Furthermore, the baseline costs indicate relatively low healthcare usage before the injury compared to the average Dutch patient. The mean QoL index was 0.462 at baseline and 0.737 at 6 months, indicating a rise in QoL after treatment as well as a long-lasting impact on QoL. To our knowledge, this is only the first study investigating the societal costs of Lisfranc injuries, so more research is needed.


Fractures, Bone , Quality of Life , Humans , Middle Aged , Cost of Illness , Netherlands/epidemiology , Health Care Costs , Fractures, Bone/epidemiology , Fractures, Bone/surgery , Surveys and Questionnaires
2.
Expert Rev Pharmacoecon Outcomes Res ; 23(4): 383-389, 2023 Apr.
Article En | MEDLINE | ID: mdl-36880336

BACKGROUND: The think-aloud (TA) approach is a qualitative research method that allows for gaining insight into thoughts and cognitive processes. It can be used to incorporate a respondent's perspective when developing resource-use measurement (RUM) instruments. Currently, the application of TA methods in RUM research is limited, and so is the guidance on how to use them. Transparent publication of TA methods for RUM in health economics studies, which is the aim of this paper, can contribute to reducing the aforementioned gap. METHODS: Methods for conducting TA interviews were iteratively developed by a multi-national working group of health economists and additional qualitative research expertise was sought. TA interviews were conducted in four countries to support this process. A ten-step process was outlined in three parts: Part A 'before the interview' (including translation, recruitment, training), Part B 'during the interview' (including setting, opening, completing the instrument, open-ended questions, closing), and part C 'after the interview' (including transcription and data analysis, trustworthiness). CONCLUSIONS: This manuscript describes the step-by-step approach for conducting multi-national TA interviews with potential respondents of the PECUNIA RUM instrument. It increases the methodological transparency in RUM development and reduces the knowledge gap of using qualitative research methods in health economics.


Research Design , Humans , Surveys and Questionnaires
4.
Expert Rev Pharmacoecon Outcomes Res ; 23(1): 135-141, 2023 Jan.
Article En | MEDLINE | ID: mdl-36472303

BACKGROUND: Health problems can lead to costs in the education sector. However, these costs are rarely incorporated in health economic evaluations due to the lack of reference unit costs (RUCs), cost per unit of service, of education services and of validated methods to obtain them. In this study, a standardized unit cost calculation tool developed in the PECUNIA project, the PECUNIA RUC Template for services, was applied to calculate the RUCs of selected education services in five European countries. METHODS: The RUCs of special education services and of educational therapy were calculated using the information collected via an exploratory gray literature search and contact with service providers. RESULTS: The RUCs of special education services ranged from €55 to €189 per school day. The RUCs of educational therapy ranged from €6 to €25 per contact and from €5 to €35 per day. Variation was observed in the type of input data and measurement unit, among other. DISCUSSION: The tool helped reduce variability in the RUCs related to costing methodology and gain insights into other aspects that contribute to the variability (e.g. data availability). Further research and efforts to generate high quality input data are required to reduce the variability of the RUCs.


Health Care Costs , Humans , Cost-Benefit Analysis , Europe , Educational Status
5.
J Ment Health ; 32(1): 150-157, 2023 Feb.
Article En | MEDLINE | ID: mdl-33086874

BACKGROUND: Little is known about the burden of (sub-threshold) mental health problems in youth. AIM: To examine the burden of mental health problems in terms of health-related quality of life (HRQoL) and cost-of-illness, for first visitors of the Dutch youth walk-in centres (@ease). METHOD: A bottom-up, prevalence-based burden of disease study from a societal perspective. HRQoL was assessed through the EuroQoL (EQ-5D-5L), and cost-of-illness via items about truancy and health care utilization. RESULTS: Participants (N = 80) showed a decreased HRQoL compared to the general population of Dutch youth. In the three months prior to their 1st attendance, participants skipped on average 4.11 days of school and had 1.03 health care visits, leading to total costs of €512.64 per person. Females had significantly higher health care costs and lower HRQoL. Health care use was lower in those not speaking the Dutch language. Living alone was a significant predictor of truancy (costs), and therefore total costs. CONCLUSIONS: Mental health problems in youth consulting @ease have a considerable impact on the individual's HRQoL, and an economic impact on society, yet almost 75% is not receiving care. A lack of interventions in this critical period in life may have major lifelong consequences.


Mental Health , Quality of Life , Female , Humans , Adolescent , Cost of Illness , Referral and Consultation , Health Care Costs , Surveys and Questionnaires
6.
BMC Neurol ; 22(1): 423, 2022 Nov 12.
Article En | MEDLINE | ID: mdl-36371162

BACKGROUND: We designed a new multi-modal version of the MSmonitor, called the MSmonitor-Plus and Video calling Care (MPVC), a self-management and education program with e-health interventions that combines frequent use of specific questionnaires with video calling in treating multiple sclerosis (MS) patients. OBJECTIVE: To assess the effectiveness, cost-effectiveness and feasibility of MPVC compared to care as usual (CAU), with the goal of achieving equal or better quality of life for MS patients and their partners/informal caregivers. Our hypothesis is that by using MPVC, monitoring will become more efficient, that patients' self-efficacy, quality of life, and adherence to treatment will improve, and that they will be able to live their lives more autonomously. METHODS: A randomized, parallel-group, open label, non-inferiority trial will be conducted to compare MPVC with CAU in MS patients and their partners/informal caregivers. A total of 208 patients will be included with follow-up measurements for 2 years (at baseline and every 3 months). One hundred four patients will be randomized to MPVC and 104 patients to CAU. Partners/informal caregivers of both groups will be asked to participate. The study will consist of three parts: 1) a clinical effectiveness study, 2) an economic evaluation, and 3) a process evaluation. The primary outcome relates to equal or improved disease-specific physical and mental quality of life of the MS patients. Secondary outcomes relate to self-efficacy, efficiency, cost-effectiveness, autonomy, satisfaction with the care provided, and quality of life of partners/informal caregivers. DISCUSSION: The idea behind using MPVC is that MS patients will gain more insight into the individual course of the disease and get a better grip on their symptoms. This knowledge should increase their autonomy, give patients more control of their condition and enable them to better and proactively interact with health care professionals. As the consulting process becomes more efficient with the use of MPVC, MS-related problems could be detected earlier, enabling earlier multidisciplinary care, treatment or modification of the treatment. This could have a positive effect on the quality of life for both the MS patient and his/her partner/informal caregiver, reducing health and social costs. TRIAL REGISTRATION: NCT05242731 Clinical Trials.gov. Date of registration: 16 February 2022 retrospectively registered.


Multiple Sclerosis , Self-Management , Female , Humans , Male , Caregivers , Cost-Benefit Analysis , Multiple Sclerosis/therapy , Quality of Life , Randomized Controlled Trials as Topic , Surveys and Questionnaires , Equivalence Trials as Topic
7.
Injury ; 53(12): 4152-4158, 2022 Dec.
Article En | MEDLINE | ID: mdl-36273922

AIM: To determine from a patient perspective what improves the quality of care and patient satisfaction during the treatment and recovery process of Lisfranc fractures and to reveal possible points for improvement in this process. METHODS: We performed a qualitative study based on semi-structured interviews with patients treated for a Lisfranc fracture-dislocation in the Netherlands with either open reduction and internal fixation or primary arthrodesis, until data saturation was reached, focusing on the quality of care during treatment and recovery, from a patient perspective. RESULTS: Data saturation was reached after interviewing 10 patients. The main themes emerging from the analysis were expectation management regarding the recovery period; communication with and between health care providers; information provided during consultations; and support during the recovery period. Participants expressed a need for improved provision of information about the different treatment options, the different kinds of pain that can arise, the expected duration of the recovery period, education on strong pain killers, likelihood of a second surgery, risks of osteoarthritis, risks of the surgery itself, allied health care and patient experiences. Participants mentioned the importance of good allied health care and a preference for starting allied health care as soon as possible. Insoles and compression socks were also appreciated by various participants. Finally, multiple patients saw a positive attitude on the part of the health care providers towards the recovery period as a key factor in recovery. CONCLUSION: This study found that patients value more tailored approaches to the pre-and post-operative care program, more guidance regarding allied health care (physiotherapy), and a broader scope of available references and information for patients, both oral (during consultations and in informative videos) and written, such as brochures or evidence-based web pages and mobile platforms, which may be offered during consultations or when being discharged from the hospital.


Foot Joints , Fractures, Bone , Humans , Foot Joints/surgery , Fractures, Bone/surgery , Fracture Fixation, Internal , Arthrodesis , Qualitative Research , Pain , Patient Outcome Assessment , Treatment Outcome
8.
Eur Spine J ; 31(5): 1206-1218, 2022 05.
Article En | MEDLINE | ID: mdl-35224672

PURPOSE: No clear consensus exists on which anterior surgical technique is most cost-effective for treating cervical degenerative disk disease (CDDD). One of the most common treatment options is anterior cervical discectomy with fusion (ACDF). Anterior cervical discectomy with arthroplasty (ACDA) was developed in an effort to reduce the incidence of clinical adjacent segment pathology and associated additional surgeries by preserving motion. This systematic review aims to evaluate the evidence regarding the cost-effectiveness of anterior surgical decompression techniques used to treat radiculopathy and/or myelopathy caused by CDDD. METHODS: The search was conducted in PubMed, EMBASE, Web of Science, CINAHL, EconLit, NHS-EED and the Cochrane Library. Studies were included if healthcare costs and utility or effectivity measurements were mentioned. RESULTS: A total of 23 studies were included out of the 1327 identified studies. In 9 of the 13 studies directly comparing ACDA and ACDF, ACDA was the most cost-effective technique, with an incremental cost effectiveness ratio ranging from $2.900/QALY to $98.475/QALY. There was great heterogeneity between the costs of due to different in- and exclusion criteria of costs and charges, cost perspective, baseline characteristics, and calculation methods. The methodological quality of the included studies was moderate. CONCLUSION: The majority of studies report ACDA to be a more cost-effective technique in comparison with ACDF. The lack of uniform literature impedes any solid conclusions to be drawn. There is a need for high-quality cost-effectiveness research and uniformity in the conduct, design and reporting of economic evaluations concerning the treatment of CDDD. TRIAL REGISTRATION: PROSPERO Registration: CRD42020207553 (04.10.2020).


Intervertebral Disc Degeneration , Spinal Fusion , Cervical Vertebrae/surgery , Cost-Benefit Analysis , Diskectomy/methods , Humans , Intervertebral Disc Degeneration/surgery , Spinal Fusion/methods , Treatment Outcome
9.
BMC Public Health ; 22(1): 46, 2022 01 07.
Article En | MEDLINE | ID: mdl-34996413

BACKGROUND: Little is known about the burden that overweight and obesity impose on Dutch society. The aim of this study is to examine this burden in terms of cost-of-illness and health-related quality of life. METHOD: A bottom-up, prevalence-based burden of disease study from a societal perspective was performed. Cost-of-illness information including healthcare costs, patient and family costs, and other costs was obtained via the Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) questionnaire. Health-related quality of life was assessed through the EuroQol (EQ-5D-5L) and the BODY-Q instruments. Non-parametric bootstrapping was applied to test for significant differences in costs. Subgroup analyses were performed on all outcomes. RESULTS: A total of 97 people with overweight and obesity completed the survey. Per respondent, mean healthcare costs were €2907, patient and family costs were €4037, and other costs were €4519, leading to a total societal cost of €11,463 per respondent per year. Total costs were significantly higher for respondents with obesity versus overweight and between low & intermediate versus highly educated respondents. The mean utility score of our population was 0.81. A significantly lower utility score was found for respondents with obesity in comparison with respondents with overweight. BODY-Q results show that respondents with obesity scored a significantly lower Rasch-score than did respondents with overweight in three scales. Respondents with a high education level and having paid work scored significantly higher Rasch-scores in two scales than did those with a low education level and without having paid work. The age group 19-29 have significantly higher Rasch-scores in three scales than respondents in the other two age categories. CONCLUSIONS: Overweight and obesity have a considerable impact on the societal costs and on health-related quality of life. The results show that the impact of overweight and obesity go beyond the healthcare sector, as the other costs have the biggest share of the total costs. Another interesting finding of this study is that obesity leads to significant higher costs and lower health-related quality of life than overweight. These findings draw attention to policy making, as collective prevention and effective treatment are needed to reduce this burden.


Overweight , Quality of Life , Cost of Illness , Health Care Costs , Humans , Obesity/epidemiology , Overweight/epidemiology , Surveys and Questionnaires
10.
BMC Surg ; 21(1): 323, 2021 Aug 12.
Article En | MEDLINE | ID: mdl-34384419

BACKGROUND: The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness. METHODS: Study design: A prospective multicenter RCT. STUDY POPULATION: All patients of 18 years and older with an acute (< 6 weeks) traumatic fracture dislocation in the Lisfranc midfoot joints, displaced on static radiographic evaluation or unstable with dynamic evaluation, weight bearing radiographs or fluoroscopic stress testing under anesthesia, and eligible for either one of the surgical procedures. In total, this study will include n = 112 patients with Lisfranc fracture dislocation. INTERVENTIONS: Patients with Lisfranc fracture dislocation will be randomly allocated to treatment in "The Better to Fix or Fuse Study" (The BFF Study) with either PA or ORIF. Main study parameters/endpoints: Primary outcome parameter: the quality of life. SECONDARY OUTCOMES: complications, functional outcomes, secondary surgical interventions and cost effectiveness. Nature and extent of the burden: PA is expected to have a better outcome, however both treatments are accepted for this injury with a similar low risk of complications. Follow up is standardized and therefore this study will not add extra burden to the patient. DISCUSSION: This study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. Trial registration Current controlled Trial: NCT04519242 with registration date: 08/13/2020. Retrospectively registered; Protocol date and version: Version 4 05/06/2020.


Fractures, Bone , Quality of Life , Arthrodesis , Cost-Benefit Analysis , Fracture Fixation, Internal , Humans , Multicenter Studies as Topic , Prospective Studies , Randomized Controlled Trials as Topic , Review Literature as Topic , Treatment Outcome
11.
BMC Med Inform Decis Mak ; 21(1): 123, 2021 04 09.
Article En | MEDLINE | ID: mdl-33836742

BACKGROUND: Since decision making about treatment with disease-modifying drugs (DMDs) for multiple sclerosis (MS) is preference sensitive, shared decision making between patient and healthcare professional should take place. Patient decision aids could support this shared decision making process by providing information about the disease and the treatment options, to elicit the patient's preference and to support patients and healthcare professionals in discussing these preferences and matching them with a treatment. Therefore, a prototype of a patient decision aid for MS patients in the Netherlands-based on the principles of multi-criteria decision analysis (MCDA) -was developed, following the recommendations of the International Patient Decision Aid Standards. MCDA was chosen as it might reduce cognitive burden of considering treatment options and matching patient preferences with the treatment options. RESULTS: After determining the scope to include DMDs labelled for relapsing-remitting MS and clinically isolated syndrome, users' informational needs were assessed using focus groups (N = 19 patients) and best-worst scaling surveys with patients (N = 185), neurologists and nurses (N = 60) to determine which information about DMDs should be included in the patient decision aid. Next, an online format and computer-based delivery of the patient decision aid was chosen to enable embedding of MCDA. A literature review was conducting to collect evidence on the effectiveness and burden of use of the DMDs. A prototype was developed next, and alpha testing to evaluate its comprehensibility and usability with in total thirteen patients and four healthcare professionals identified several issues regarding content and framing, methods for weighting importance of criteria in the MCDA structure, and the presentation of the conclusions of the patient decision aid ranking the treatment options according to the patient's preferences. Adaptations were made accordingly, but verification of the rankings provided, validation of the patient decision aid, evaluation of the feasibility of implementation and assessing its value for supporting shared decision making should be addressed in further development of the patient decision aid. CONCLUSION: This paper aimed to provide more transparency regarding the developmental process of an MCDA-based patient decision aid for treatment decisions for MS and the challenges faced during this process. Issues identified in the prototype were resolved as much as possible, though some issues remain. Further development is needed to overcome these issues before beta pilot testing with patients and healthcare professionals at the point of clinical decision-making can take place to ultimately enable making conclusions about the value of the MCDA-based patient decision aid for MS patients, healthcare professionals and the quality of care.


Multiple Sclerosis , Pharmaceutical Preparations , Decision Making , Decision Support Techniques , Humans , Multiple Sclerosis/drug therapy , Netherlands , Patient Preference
12.
BMC Health Serv Res ; 20(1): 1049, 2020 Nov 17.
Article En | MEDLINE | ID: mdl-33203405

BACKGROUND: Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke. METHODS / DESIGN: A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside. DISCUSSION: This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke. TRIAL REGISTRATION: Netherlands Trial Register: NL7295 , registered 25 September 2018.


Brain Ischemia , Ischemic Stroke , Stroke Rehabilitation , Stroke , Adolescent , Cognition , Cost-Benefit Analysis , Humans , Multicenter Studies as Topic , Netherlands , Patient Discharge , Quality of Life , Randomized Controlled Trials as Topic , Stroke/therapy
13.
Diabet Med ; 37(10): 1759-1765, 2020 10.
Article En | MEDLINE | ID: mdl-32112462

AIMS: To estimate the societal costs and quality of life of people with type 2 diabetes and to compare these results with those of people with normal glucose tolerance or prediabetes. METHODS: Data from 2915 individuals from the population-based Maastricht Study were included. Costs were assessed through a resource-use questionnaire completed by the participants; cost prices were based on Dutch costing guidelines. Quality of life was expressed in utilities using the Dutch EuroQol 5D-3L questionnaire and the SF-36 health survey. Based on normal fasting glucose and 2-h plasma glucose values, participants were classified into three groups: normal glucose tolerance (n = 1701); prediabetes (n = 446); or type 2 diabetes (n = 768). RESULTS: Participants with type 2 diabetes had on average 2.2 times higher societal costs than those with normal glucose tolerance (€3,006 and €1,377 per 6 months, respectively) and had lower utilities (0.77 and 0.81, respectively). No significant differences were found between participants with normal glucose tolerance and those with prediabetes. Subgroup analyses showed that higher age, being female and having two or more diabetes-related complications resulted in higher costs (P < 0.05) and lower utilities. CONCLUSIONS: This study showed that people with type 2 diabetes have substantially higher societal costs and lower quality of life than people with normal glucose tolerance. The results provide important input for future model-based economic evaluations and for policy decision-making.


Cost of Illness , Diabetes Mellitus, Type 2/economics , Health Care Costs , Prediabetic State/economics , Quality of Life , Adult , Aged , Case-Control Studies , Diabetes Mellitus, Type 2/physiopathology , Diabetes Mellitus, Type 2/psychology , Female , Humans , Linear Models , Male , Middle Aged , Netherlands , Prediabetic State/physiopathology , Prediabetic State/psychology
14.
Expert Rev Pharmacoecon Outcomes Res ; 20(2): 193-198, 2020 Apr.
Article En | MEDLINE | ID: mdl-31190575

Objective: To assess the quality of life and societal costs of patients prior to colorectal surgery in the Netherlands.Methods: This study is embedded in a previous randomized controlled trial (SANICS II). The quality of life was measured using EQ-5D-5L questionnaires. The iMTA medical consumption questionnaire (iMCQ) and the iMTA productivity costs questionnaire (iPCQ) were used to identify and measure healthcare and productivity costs. Subgroup analyses were performed based on age and gender.Results: A total of 178 patients were included in the cost analysis and a total of 161 patients in the quality of life analysis. The three-month mean societal cost per patient amounted to €3,211 of which €1,459 was due to productivity losses. The mean utility was 0.88 per patient. Gender was an important predictor in quality of life with men scoring significantly higher than women (0.92 versus 0.82) at p < 0.0001.Conclusion: Colorectal cancer represents a high economic burden in the Netherlands. Further research with repeated cost and quality of life measurements would be needed to explore the change over time and the effects of surgery.


Colorectal Neoplasms/economics , Cost of Illness , Health Care Costs/statistics & numerical data , Quality of Life , Aged , Colorectal Neoplasms/pathology , Colorectal Neoplasms/therapy , Efficiency , Female , Humans , Male , Middle Aged , Netherlands , Sex Factors , Surveys and Questionnaires
15.
BMC Psychiatry ; 19(1): 130, 2019 04 30.
Article En | MEDLINE | ID: mdl-31039765

BACKGROUND: Despite multiple pharmacological interventions, many people with bipolar disorder (BD) experience substantial residual mood symptoms, even in the absence of severe mood episodes, which have a negative impact on the course of illness and quality of life. Limited data are available on how to optimize treatment for BD, especially for those who suffer from persistent and residual depressive symptoms. Preliminary evidence suggests Mindfulness-Based Cognitive Therapy (MBCT) as a psychological treatment option for BD. This study aims to investigate whether adding MBCT to treatment as usual (TAU) will result in symptomatic and functional improvements in adults with BD compared to TAU alone. METHODS/DESIGN: This study is a prospective, evaluator blinded, multicenter, randomized controlled trial of MBCT + TAU and TAU alone in 160 adults with bipolar type I and type II. Assessments will be conducted at baseline (T0), mid-treatment (Tmid), and at 3 (T1), 6 (T2), 9 (T3), 12 (T4), and 15 (T5) months follow-up. Primary outcome is post-treatment severity of depressive symptoms (Inventory of Depressive Symptomatology- Clinician administered). Secondary outcomes are severity of (hypo) manic symptoms, anxiety, relapse rates, overall functioning, positive mental health, and cost-effectiveness. As possible mediators will be assessed rumination of negative affect, dampening and rumination of positive affect, mindfulness skills, and self-compassion. DISCUSSION: This study will provide valuable insight into the (cost-)effectiveness of MBCT on clinician- and self-rated symptoms of BD, relapse rates, positive mental health, and overall functioning. TRIAL REGISTRATION: NCT03507647 . Registered 25th of April 2018.


Bipolar Disorder/therapy , Cognitive Behavioral Therapy/methods , Mindfulness/methods , Adult , Bipolar Disorder/psychology , Female , Follow-Up Studies , Humans , Male , Netherlands , Prospective Studies , Research Design , Treatment Outcome , Young Adult
17.
J Nutr Health Aging ; 22(7): 766-773, 2018.
Article En | MEDLINE | ID: mdl-30080217

OBJECTIVE: To assess the association between muscle parameters (mass, strength, physical performance) and activities of daily living (ADL), quality of life (QoL), and health care costs. DESIGN: Cross-sectional Maastricht Sarcopenia Study (MaSS). SETTING: Community-dwelling, assisted-living, residential living facility. PARTICIPANTS: 227 adults aged 65 and older. MEASUREMENTS: Muscle mass, hand grip strength and physical performance were assessed by bio-electrical impedance, JAMAR dynamometer and the Short Physical Performance Battery, respectively. Health outcomes were measured by the Groningen Activity Restriction Scale (disability in ADL) and the EQ-5D-5L (QoL). Health care costs were calculated based on health care use in the past three months. RESULTS: Muscle strength and physical performance showed a strong correlation with ADL, QoL, and health care costs (P<.01); for muscle mass no significant correlations were observed. Regression analyses showed that higher gait speed (OR 0.06, 95%CI 0.01-0.55) was associated with a lower probability of ADL disability. Furthermore, slower chair stand (OR 1.23, 95%CI 1.08-1.42), and more comorbidities (OR 1.58, 95%CI 1.23-2.02) were explanatory factors for higher ADL disability. Explanatory factors for QoL and costs were: more disability in ADL (OR 1.26, 95%CI 1.12-1.41 for QoL; B = 0.09, P<.01 for costs) and more comorbidities (OR 1.44, 95%CI 1.14-1.82 for QoL; B = 0.35, P<.01 for costs). CONCLUSION: Lower gait speed and chair stand were potential drivers of disability in ADL. Disability in ADL and comorbidities were associated with QoL and health care costs in community-dwelling older adults. Improving physical performance may be a valuable target for future intervention and research to impact health burden and costs.


Activities of Daily Living/psychology , Gait/physiology , Hand Strength/physiology , Health Care Costs/statistics & numerical data , Muscle Strength/physiology , Quality of Life/psychology , Walking Speed/physiology , Aged , Aged, 80 and over , Comorbidity , Cross-Sectional Studies , Disabled Persons , Electric Impedance , Female , Humans , Independent Living , Male , Sarcopenia/epidemiology
18.
Expert Rev Pharmacoecon Outcomes Res ; 18(3): 297-304, 2018 Jun.
Article En | MEDLINE | ID: mdl-29303374

BACKGROUND: To enhance usage of health technology assessment (HTA) in decision-making, it is important to prioritise important barriers and facilitators to the uptake of HTA. This study aims to quantify and compare the relative importance of barriers and facilitators regarding the use of HTA in several European countries. METHODS: A survey containing two best-worst scaling (BWS) object case studies (i.e. barriers and facilitators) were conducted among 136 policy makers and HTA researchers from the Netherlands, Germany, France, and United Kingdom. Hierarchical Bayes analysis generated the mean relative importance score (RIS) for each factor and subgroup analyses assessed differences between countries. RESULTS: Six barriers (RIS≥5) and five facilitators (RIS≥6) were deemed highly important. Eleven barriers and ten facilitators differed in their importance between countries. Policy characteristics, research & researcher characteristics, and organisation & resources were particularly important to facilitate uptake of HTA, such as an explicit framework for decision-making and research of sufficient quality. CONCLUSION: The most paramount barriers and facilitators to HTA usage were quantified. For all countries it is crucial to create an explicit framework for the decision-making context to include HTA evidence. Country differences in the quality of research emphasize the need for enhanced international collaboration in HTA.


Decision Making , Health Policy , Technology Assessment, Biomedical/methods , Administrative Personnel , Europe , Humans , International Cooperation , Research/standards
19.
J Hum Nutr Diet ; 30(5): 554-562, 2017 10.
Article En | MEDLINE | ID: mdl-28322468

BACKGROUND: The Nutrition Education for Management of Osteodystrophy trial showed that stage-based nutrition education by dedicated dietitians surpasses existing practices in Lebanon with respect to lowering serum phosphorus among general haemodialysis patients. The present study explores the effect of nutrition education specifically on hyperphosphataemic patients from this trial. METHODS: Hyperphosphataemic haemodialysis patients were allocated to a dedicated dietitian (DD), a trained hospital dietitian (THD) and existing practice (EP) protocols. From time-point (t)-0 until t-1 (6 months), the DD group (n = 47) received 15 min of biweekly nutrition education by dedicated dietitians trained on renal nutrition; the THD group (n = 89) received the usual care from trained hospital dietitians; and the EP group (n = 42) received the usual care from untrained hospital dietitians. Patients were followed-up from t-1 until t-2 (6 months). Analyses used two-way repeated measures analysis of variance and Cohen's effect sizes (d). RESULTS: At t-1, phosphataemia significantly decreased in all groups (DD:-0.27 mmol L-1 ; EP:-0.15 mmol L-1 ; THD:-0.12 mmol L-1 ; P < 0.05); the DD protocol had the greatest effect relative to EP (d = -0.35) and THD (d = -0.50). Only the DD group showed more readiness to adhere to a low phosphorus diet at t-1; although, at t-2, this regressed to baseline levels. The malnutrition inflammation score remained stable only in the DD group, whereas the EP and THD groups exhibited a significant increase (DD: 6.74, 6.97 and 7.91; EP: 5.82, 8.69 and 8.13; THD: 5.33, 7.92 and 9.42, at t-0, t-1 and t-2, respectively). CONCLUSIONS: The results of the present study suggest that the DD protocol decreases serum phosphorus compared to EP and THD, at the same time as maintaining the nutritional status of hyperphosphataemic haemodialysis patients. Assessing the cost-effectiveness of the DD protocol is recommended.


Disease Management , Health Education , Hyperphosphatemia/diet therapy , Renal Dialysis/adverse effects , Adult , Aged , Body Mass Index , Counseling , Dietary Proteins/administration & dosage , Female , Follow-Up Studies , Humans , Lebanon , Male , Malnutrition/blood , Malnutrition/diagnosis , Malnutrition/diet therapy , Middle Aged , Nutritional Status , Nutritionists , Phosphorus, Dietary/administration & dosage , Phosphorus, Dietary/blood , Socioeconomic Factors
20.
BMC Health Serv Res ; 16(1): 688, 2016 12 13.
Article En | MEDLINE | ID: mdl-27964721

BACKGROUND: Post-stroke healthcare consumption is strongly associated with a mental health diagnosis. This study aimed to identify stroke patients who utilised mental healthcare facilities, explored their mental healthcare consumption pre-stroke and post-stroke, and examined possible predictors of costs incurred by mental healthcare consumption post-stroke. METHODS: Three databases were integrated, namely the Maastricht University Medical Centre (MUMC) Medical Administration, the Stroke Registry from the Department of Neurology at MUMC, and the Psychiatric Case Registry South-Limburg. Patients from the MUMC who suffered their first-ever stroke between January 1 2000 and December 31 2004 were included and their records were analysed for mental healthcare consumption from 5 years preceding to 5 years following their stroke (1995-2009). Regression analysis was conducted to identify possible predictors of mental healthcare consumption costs. RESULTS: A total of 1385 patients were included and 357 (25.8%) received services from a mental healthcare facility during the 10-year reference period around their stroke. The costs of mental healthcare usage increased over time and peaked 1 year post-stroke (€7057; 22% of total mental healthcare costs). The number of hospitalisation days and mental healthcare consumption pre-stroke were significant predictors of mental healthcare costs. Explained variances of these models (costs during the 5 years post-stroke: R 2 = 15.5%, costs across a 10 year reference period: R 2 = 4.6%,) were low. CONCLUSION: Stroke patients have a significant level of mental healthcare comorbidity leading to relatively high mental healthcare costs. There is a relationship between stroke and mental healthcare consumption costs, but results concerning the underlying factors responsible for these costs are inconclusive.


Mental Health Services/statistics & numerical data , Stroke/economics , Aged , Costs and Cost Analysis , Databases, Factual , Epidemiologic Methods , Female , Health Care Costs , Hospitals, Psychiatric/statistics & numerical data , Humans , Male , Mental Health Services/economics , Netherlands
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