Study Design: Literature review.Objective: To describe whether practice variation studies on surgery in patients with lumbar degenerative disc disease used adequate study methodology to identify... Show moreStudy Design: Literature review.Objective: To describe whether practice variation studies on surgery in patients with lumbar degenerative disc disease used adequate study methodology to identify unwarranted variation, and to inform quality improvement in clinical practice. Secondary aim was to describe whether variation changed over time.Methods: Literature databases were searched up to May 4th, 2021. To define whether study design was appropriate to identify unwarranted variation, we extracted data on level of aggregation, study population, and case-mix correction. To define whether studies were appropriate to achieve quality improvement, data were extracted on outcomes, explanatory variables, description of scientific basis, and given recommendations. Spearman's rho was used to determine the association between the Extreme Quotient (EQ) and year of publication.Results: We identified 34 articles published between 1990 and 2020. Twenty-six articles (76%) defined the diagnosis. Prior surgery cases were excluded or adjusted for in 5 articles (15%). Twenty-three articles (68%) adjusted for case-mix. Variation in outcomes was analyzed in 7 articles (21%). Fourteen articles (41%) identified explanatory variables. Twenty-six articles (76%) described the evidence on effectiveness. Recommendations for clinical practice were given in 9 articles (26%). Extreme Quotients ranged between 1-fold and 15-fold variation and did not show a significant change over time (rho= -.33, P= .09).Conclusions: Practice variation research on surgery in patients with degenerative disc disease showed important limitations to identify unwarranted variation and to achieve quality improvement by public reporting. Despite the availability of new evidence, we could not observe a significant decrease in variation over time. Show less
Suvaal, I.; Hummel, S.B.; Mens, J.W.M.; Doorn, H.C. van; Hout, W.B. van den; Creutzberg, C.L.; Kuile, M.M. ter 2021
Background: Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy ... Show moreBackground: Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy (EBRT+BT). Studies demonstrate that psychosexual support should include cognitive behavioural interventions and involvement of the patient's partner, if available. Therefore, we developed a nurse-led sexual rehabilitation intervention, including these key components. The intervention was previously pilot-tested and results demonstrated that this intervention improves women's sexual functioning and increases dilator compliance. The objective of the current study is to investigate the (cost-)effectiveness of the intervention compared to optimal care as usual (CAU). We expect that women who receive the intervention will report a statistically significant greater improvement in sexual functioning and - for women who receive EBRT+BT - higher compliance with dilator use, from baseline to 12 months post-RT than women who receive optimal care as usual (CAU).Methods/design: The intervention is evaluated in the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre, randomized controlled trial (RCT). The primary endpoint is sexual functioning. Secondary outcomes include body image, fear of sexual activity, sexual-, treatment-related- and psychological distress, health-related quality of life and relationship satisfaction. A cost-effectiveness analysis (CEA) will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. The study sample will consist of 220 women with GC treated with RT in specialized GC treatment centres (N = 10). Participants are randomized to either the intervention- or CAU control group (1:1), and within each centre stratified by type of radiotherapy (EBRT+BT vs. EBRT only) and having a partner (yes/no). All women complete questionnaires at baseline (T1) and at 1, 3, 6, and 12 months post-RT (T2, T3, T4 and T5, respectively).Discussion: There is a need to improve sexual functioning after RT for GC. This RCT will provide evidence about the (cost-)effectiveness of a nurse-led sexual rehabilitation intervention. If proven effective, the intervention will be a much needed addition to care offered to GC survivors and will result in improved quality of life. Show less
Wissen, M.A.T. van; Teuwen, M.M.H.; Ende, C.H.M. van den; Vlieland, T.P.M.V.; Broeder, A.A. den; Hout, W.B. van den; ... ; Weely, S.F.E. van 2021
Objectives Research on effectiveness and cost-effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly... Show moreObjectives Research on effectiveness and cost-effectiveness of longstanding exercise therapy in patients with axial SpondyloArthritis (axSpA) or Rheumatoid Arthritis (RA) is scarce, and mainly concerned patients with a relatively favorable health status. We aim to evaluate the effectiveness and cost-effectiveness of longstanding exercise therapy compared to usual care in the subgroup of patients with axSpA or RA and severe limitations in functioning. Methods In two separate, parallel randomized controlled trials the effectiveness and cost-effectiveness of longstanding, active exercise therapy (52 weeks) compared with usual care (1:1) will be evaluated. The longstanding, active exercise therapy will focus on improving individual limitations in daily activities and participation and will be given by a trained physical therapist in the vicinity of the participant. For each diagnosis, 215 patients with severe limitations in activities and participation will be included. Assessments are performed at baseline, 12, 26, and 52 weeks. The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument at 52 weeks. For cost-effectiveness analyses, the EuroQol (EQ-5D-5L) and questionnaires on healthcare use and productivity will be administered. The economic evaluation will be a cost-utility analysis from a societal perspective. After 52 weeks, the patients in the usual care group are offered longstanding, active exercise therapy as well. Follow-up assessments are done at 104, 156, and 208 weeks. Conclusion The results of these studies will provide insights in the effectiveness and cost-effectiveness of longstanding exercise therapy in the subgroup of axSpA and RA patients with severe functional limitations. Show less
Neve, O.M.; Boerman, J.A.; Hout, W.B. van den; Briaire, J.J.; Benthem, P.P.G. van; Frijns, J.H.M. 2021
Objectives: While the costs and outcomes of cochlear implantation (CI) have been widely assessed, most of these analyses were solely performed from the perspective of healthcare costs. This study... Show moreObjectives: While the costs and outcomes of cochlear implantation (CI) have been widely assessed, most of these analyses were solely performed from the perspective of healthcare costs. This study assesses the costs and benefits of CI in the Netherlands from a broader societal perspective, including health outcomes, healthcare cost, educational cost, and productivity losses and gains. Design: The cost and benefits of CI were analyzed in this cost-benefit analysis, in which a monetary value is put on both the resources needed and the outcomes of CI. The costs and benefits were analyzed by prototypical instances of three groups, representing the majority of cochlear implant patients: prelingually deaf children implanted at the age of 1, adults with progressive profound hearing loss implanted at the age of 40 and seniors implanted at the age of 70 with progressive profound hearing loss. Costs and benefits were estimated over the expected lifetimes of the members of each group, using a Markov state transition model. Model parameters and assumptions were based on published literature. Probabilistic and one-way sensitivity analyses were performed. Results: In all three patient groups, the total benefits of CI exceeded the total cost, leading to a net benefit of CI. Prelingually deaf children with a bilateral CI had a lifetime positive outcome net benefit of euro433,000. Adults and seniors with progressive profound hearing loss and a unilateral CI had a total net benefit of euro275,000 and euro76,000, respectively. These results ensue from health outcomes expressed in monetary terms, reduced educational cost, and increased productivity. Conclusions: Based on estimates from modeling, the increased healthcare costs due to CI were more than compensated by the value of the health benefits and by savings in educational and productivity costs. In particular, for children and working adults, the societal benefit was positive even without taking health benefits into account. Therefore, CI generates an advantage for both patients and society. Show less
Boon, G.J.A.M.; Hout, W.B. van den; Barco, S.; Bogaard, H.J.; Delcroix, M.; Huisman, M.V.; ... ; Klok, F.A. 2021
Background Diagnostic delay of chronic thromboembolic pulmonary hypertension (CTEPH) exceeds 1 year, contributing to higher mortality. Health economic consequences of late CTEPH diagnosis are... Show moreBackground Diagnostic delay of chronic thromboembolic pulmonary hypertension (CTEPH) exceeds 1 year, contributing to higher mortality. Health economic consequences of late CTEPH diagnosis are unknown. We aimed to develop a model for quantifying the impact of diagnosing CTEPH earlier on survival, quality-adjusted life-years (QALYs) and healthcare costs.Material and methods A Markov model was developed to estimate lifelong outcomes, depending on the degree of delay. Data on survival and quality of life were obtained from published literature. Hospital costs were assessed from patient records (n=498) at the Amsterdam UMC - VUmc, which is a Dutch CTEPH referral center. Medication costs were based on a mix of standard medication regimens.Results For 63-year-old CTEPH patients with a 14-month diagnostic delay of CTEPH (median age and delay of patients in the European CTEPH Registry), lifelong healthcare costs were estimated at EUR 117100 for a mix of treatment options. In a hypothetical scenario of maximal reduction of current delay, improved survival was estimated at a gain of 3.01 life-years and 2.04 QALYs. The associated cost increase was EUR 44654, of which 87% was due to prolonged medication use. This accounts for an incremental cost-utility ratio of EUR 21900/QALY.Conclusion Our constructed model based on the Dutch healthcare setting demonstrates a substantial health gain when CTEPH is diagnosed earlier. According to Dutch health economic standards, additional costs remain below the deemed acceptable limit of EUR 50000/QALY for the particular disease burden. This model can be used for evaluating cost-effectiveness of diagnostic strategies aimed at reducing the diagnostic delay. Show less
Objective: To estimate societal costs and changes in health-related quality of life in stroke patients, up to one year after start of medical specialist rehabilitation.& nbsp; Design:... Show moreObjective: To estimate societal costs and changes in health-related quality of life in stroke patients, up to one year after start of medical specialist rehabilitation.& nbsp; Design: Observational.& nbsp; Patients: Consecutive patients who received med ical specialist rehabilitation in the Stroke Cohort Out-comes of REhabilitation (SCORE) study.& nbsp; Methods: Participants completed questionnaires on health-related quality of life (EuroQol EQ-5D-3L), absenteeism, out-of-pocket costs and healthcare use at start and end of rehabilitation and 6 and 12 months after start. Clinical characteristics and reha-bilitation costs were extracted from the medical and financial records, respectively.& nbsp; Results: From 2014 to 2016 a total of 313 stroke patients completed the study. Mean age was 59 (standard deviation (SD) 12) years, 185 (59%) were male, and 244 (78%) inpatients. Mean costs for inpatient and outpatient rehabilitation were US$70,601 and US$27,473, respectively. For in-patients, utility (an expression of quality of life) in-creased significantly between baseline and 6 months (EQ-5D-3L 0.66 & ndash;0.73, p = 0.01; visual analogue scale 0.77 & ndash;0.82, p < 0.001) and between baseline and 12 months (visual analogue scale 0.77 & ndash;0.81, p < 0.001).& nbsp; Conclusion: One-year societal costs from after the start of rehabilitation in stroke patients were con-siderable. Future research should also include costs prior to rehabilitation. For inpatients, health-related quality of life, expressed in terms of utility, improved significantly over time. Show less
Hendriks, S.V.; Hout, W.B. van den; Bemmel, T. van; Bistervels, I.M.; Eijsvogel, M.; Faber, L.M.; ... ; YEARS Investigators 2021
Background Venous thromboembolism constitutes substantial health care costs amounting to approximately 60 million euros per year in the Netherlands. Compared with initial hospitalization, home... Show moreBackground Venous thromboembolism constitutes substantial health care costs amounting to approximately 60 million euros per year in the Netherlands. Compared with initial hospitalization, home treatment of pulmonary embolism (PE) is associated with a cost reduction. An accurate estimation of cost savings per patient treated at home is currently lacking.Aim The aim of this study was to compare health care utilization and costs during the first 3 months after a PE diagnosis in patients who are treated at home versus those who are initially hospitalized.Methods Patient-level data of the YEARS cohort study, including 383 normotensive patients diagnosed with PE, were used to estimate the proportion of patients treated at home, mean hospitalization duration in those who were hospitalized, and rates of PE-related readmissions and complications. To correct for baseline differences within the two groups, regression analyses was performed. The primary outcome was the average total health care costs during a 3-month follow-up period for patients initially treated at home or in hospital.Results Mean hospitalization duration for the initial treatment was 0.69 days for those treated initially at home ( n =181) and 4.3 days for those initially treated in hospital ( n =202). Total average costs per hospitalized patient were Euro3,209 and Euro1,512 per patient treated at home. The adjusted mean difference was Euro1,483 (95% confidence interval: Euro1,181-1,784).Conclusion Home treatment of hemodynamically stable patients with acute PE was associated with an estimated net cost reduction of Euro1,483 per patient. This difference underlines the advantage of triage-based home treatment of these patients. Show less
Dam, L.F. van; Hout, W.B. van den; Gautam, G.; Dronkers, C.E.A.; Ghanima, W.; Gleditsch, J.; ... ; Klok, F.A. 2021
The diagnostic workup of recurrent ipsilateral deep vein thrombosis (DVT) using compression ultrasonography (CUS) can be complicated by persistent intravascular abnormalities after a previous DVT.... Show moreThe diagnostic workup of recurrent ipsilateral deep vein thrombosis (DVT) using compression ultrasonography (CUS) can be complicated by persistent intravascular abnormalities after a previous DVT. We showed that magnetic resonance direct thrombus imaging (MRDTI) can exclude recurrent ipsilateral DVT. However, it is unknown whether the application of MRDTI in daily clinical practice is cost effective. The aim of this study was to evaluate the cost effectiveness of MRDTI-based diagnosis for suspected recurrent ipsilateral DVT during first year of treatment and follow-up in the Dutch health care setting. Patientlevel data of the Theia study (NCT02262052) were analyzed in 10 diagnostic scenarios, including a clinical decision rule and D-dimer test and imaging with CUS and/or MRDTI. The total costs of diagnostic tests and treatment during 1-year follow-up, including costs of false-positive and false-negative diagnoses, were compared and related to the associated mortality. The 1-year health care costs with MRDTI (range, (sic)1219-1296) were generally lower than strategies without MRDTI (range, (sic)1278-1529). This was because of superior specificity, despite higher initial diagnostic costs. Diagnostic strategies including CUS alone and CUS followed by MRDTI in case of an inconclusive CUS were potential optimal cost-effective strategies, with estimated average costs of (sic)1529 and (sic)1263 per patient and predicted mortality of 1 per 737 patients and 1 per 609 patients, respectively. Our model shows that diagnostic strategies with MRDTI for suspected recurrent ipsilateral DVT have generally lower 1-year health care costs than strategies without MRDTI. Therefore, compared with CUS alone, applying MRDTI did not increase health care costs. Show less
Sawatzky, R.; Kwon, J.Y.; Barclay, R.; Chauhan, C.; Frank, L.; Hout, W.B. van den; ... ; Response Shift Syn 2021
Purpose Results of patient-reported outcome measures (PROMs) are increasingly used to inform healthcare decision-making. Research has shown that response shift can impact PROM results. As part of... Show morePurpose Results of patient-reported outcome measures (PROMs) are increasingly used to inform healthcare decision-making. Research has shown that response shift can impact PROM results. As part of an international collaboration, our goal is to provide a framework regarding the implications of response shift at the level of patient care (micro), healthcare institute (meso), and healthcare policy (macro). Methods Empirical evidence of response shift that can influence patients' self-reported health and preferences provided the foundation for development of the framework. Measurement validity theory, hermeneutic philosophy, and micro-, meso-, and macro-level healthcare decision-making informed our theoretical analysis. Results At the micro-level, patients' self-reported health needs to be interpreted via dialogue with the clinician to avoid misinterpretation of PROM data due to response shift. It is also important to consider the potential impact of response shift on study results, when these are used to support decisions. At the meso-level, individual-level data should be examined for response shift before aggregating PROM data for decision-making related to quality improvement, performance monitoring, and accreditation. At the macro-level, critical reflection on the conceptualization of health is required to know whether response shift needs to be controlled for when PROM data are used to inform healthcare coverage. Conclusion Given empirical evidence of response shift, there is a critical need for guidelines and knowledge translation to avoid potential misinterpretations of PROM results and consequential biases in decision-making. Our framework with guiding questions provides a structure for developing strategies to address potential impacts of response shift at micro-, meso-, and macro-levels. Show less
Bonten, T.N.; Verkleij, S.M.; Kleij, R.M.J.J. van der; Busch, K.; Hout, W.B. van den; Chavannes, N.H.; Numans, M.E. 2021
Introduction Lifestyle interventions are shown to be effective in improving cardiovascular disease (CVD) risk factors. It has been suggested that general practitioners can play an essential role in... Show moreIntroduction Lifestyle interventions are shown to be effective in improving cardiovascular disease (CVD) risk factors. It has been suggested that general practitioners can play an essential role in CVD prevention. However, studies into lifestyle interventions for primary care patients at high cardiovascular risk are scarce and structural implementation of lifestyle interventions can be challenging. Therefore, this study aims to (1) evaluate (cost-)effectiveness of implementation of an integrated group-based lifestyle programme in primary care practices; (2) identify effective intervention elements and (3) identify implementation determinants of an integrated group-based lifestyle intervention for patients with high cardiovascular risk. Methods and analysis The Healthy Heart study is a non-randomised cluster stepped-wedge trial. Primary care practices will first offer standard care during a control period of 2-6 months, after which practices will switch (step) to the intervention, offering participants a choice between a group-based lifestyle programme or standard care. Participants enrolled during the control period (standard care) will be compared with participants enrolled during the intervention period (combined standard care and group-based lifestyle intervention). We aim to include 1600 primary care patients with high cardiovascular risk from 55 primary care practices in the area of The Hague, the Netherlands. A mixed-methods process evaluation will be used to simultaneously assess effectiveness and implementation outcomes. The primary outcome measure will be achievement of individual lifestyle goals after 6 months. Secondary outcomes include lifestyle change of five lifestyle components (smoking, alcohol consumption, diet, weight and physical activity) and improvement of quality of life and self-efficacy. Outcomes are assessed using validated questionnaires at baseline and 3, 6, 12 and 24 months of follow-up. Routine care data will be used to compare blood pressure and cholesterol levels. Cost-effectiveness of the lifestyle intervention will be evaluated. Implementation outcomes will be assessed using the RE-AIM model, to assesses five dimensions of implementation at different levels of organisation: reach, efficacy, adoption, implementation and maintenance. Determinants of adoption and implementation will be assessed using focus groups consisting of professionals and patients. Ethics and dissemination This study is approved by the Ethics Committee of the Leiden University Medical Center (P17.079). Results will be shared with the primary care group, healthcare providers and patients, and will be disseminated through journal publications and conference presentations. Show less
Objective In the past few decades, there has been an increase in high-quality studies providing evidence on the effectiveness of commonly performed procedures in paediatric otolaryngology. We... Show moreObjective In the past few decades, there has been an increase in high-quality studies providing evidence on the effectiveness of commonly performed procedures in paediatric otolaryngology. We believe that now is the time to re-evaluate the care process. We aimed to analyse (1) the regional variation in incidence and referrals of adenoidectomies, tonsillectomies and ventilation tube insertions in children in the Netherlands between 2016 and 2019, (2) whether regional surgical rates, referral rates and in-hospital surgical rates were associated with one another, and (3) the hospital variation in healthcare costs, which indicates the utilisation of resources. Design Repeated cross-sectional analysis. Setting Four neighbouring Dutch provinces comprising 2.8 million inhabitants and 14 hospitals. Participants Children aged 0-15 years. Outcome measures We analysed variation in regional surgical rates and referral rates per 1000 inhabitants and in-hospital surgical rates per 1000 clinic visitors, adjusted for age and socioeconomic status. Furthermore, the relationships between referral rates, regional surgical rates and in-hospital surgical rates were estimated. Lastly, variation in resource utilisation between hospitals was estimated. Results Adenoidectomy rates differed sixfold between regions. Twofold differences were observed for adenotonsillectomy rates, ventilation tube insertion rates and referral rates. Referral rates were negatively associated with in-hospital surgical rates for adenotonsillectomies, but not for adenoidectomies and ventilation tube insertions. In-hospital surgical rates were positively associated with regional rates for adenoidectomies and adenotonsillectomies. Significant variation between hospitals was observed in costs for all resources. Conclusions We observed low variation in tonsillectomies and ventilation tube insertion and high variation in adenoidectomies. Indications for a tonsillectomy and ventilation tube insertion are well defined in Dutch guidelines, whereas this is not the case for an adenoidectomy. Lack of agreement on indications can be expected and high-quality effectiveness research is required to improve evidence-based guidelines on this topic. Show less
Introduction Outcomes of surgery for Meniere's disease (MD) remain discordant. Recently, a new surgical procedure in which the endolymphatic duct is clipped was proposed. To date, only one... Show moreIntroduction Outcomes of surgery for Meniere's disease (MD) remain discordant. Recently, a new surgical procedure in which the endolymphatic duct is clipped was proposed. To date, only one prospective trial assessing this technique was published, yielding promising results. This protocol describes a prospective, double-blinded, randomised controlled trial that will be carried out to assess the effectiveness of this surgical intervention.Methods Eighty-four patients with intractable MD will be recruited from 13 hospitals in the Netherlands. Intraoperatively, randomisation will determine whether endolymphatic duct blockage (EDB) or endolymphatic sac decompression (ESD) will be performed. Randomisation will be 1:1 stratified for gender and duration of MD (recent-onset versus mature MD). All participants receive vestibular rehabilitation after surgery. Patients are followed up during 1 year after surgery. Follow-up visits will take place at 1 week, 3 months, 6 months and 12 months after surgery. The main study endpoint is proportion of patients who are free of vertigo spells at 12 months postoperatively. Secondary parameters include cumulative number of vertigo bouts, co-intervention, tinnitus, hearing, quality of life, cost effectiveness and a budget impact analysis. Total duration of the study is 4 years.Analysis The primary analysis will follow the intention-to-treat principle. For the primary outcome, a chi(2) test will be performed. Secondary outcomes will be analysed using a linear mixed model (EDB versus decompression group) at the different time measurement point.Ethics and dissemination This study was reviewed and approved by a board of specialists before funding was obtained, as well as by the Medical Research Ethics Committee Leiden-The Hague-Delft and the boards of all participating centres. Results of this study will be published in international peer-reviewed scientific journals and will be presented on (inter)national scientific conferences and meetings. Show less
