Objective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with... Show moreObjective: To assess the predictive accuracy of the sFlt-1/PlGF ratio cut-off 38 in addition to the standard-of-care spot urine protein/creatinine ratio (PCr) for multiple pregnancies in women with suspected pre-eclampsia. Study design: Post-hoc analysis of a prospective cohort study. Main outcome measures: Primary outcome was the occurrence of pre-eclampsia in one and four weeks after presentation with suspected pre-eclampsia. Test characteristics with 95% confidence intervals (CI) were calculated on pre-eclampsia development in one and four weeks. Results: Twenty-three multiple pregnancies with suspected pre-eclampsia between 20 and 37 weeks gestation were included for analysis. Women who eventually developed pre-eclampsia had a significantly higher PCr (34.0 vs. 16.5, p = 0.015), sFlt-1 (17033 vs. 5270 pg/ml, p = 0.047) and sFlt-1/PlGF ratio (99 vs. 25, p = 0.033) at baseline. Furthermore, PCr ≥ 30 and sFlt-1/PlGF ratio > 38 was respectively seen in 1/16 (6.3 %) and 3/16 (18.8 %) of the women who did not develop pre-eclampsia. For predicting pre-eclampsia within one week the sFlt-1/PlGF ratio sensitivity was 75.0 % [95 % CI 19.4–99.4] and the negative predictive value 93.8 % [73.0–98.8], while no pre-eclampsia developed when PCr was < 30. Consequently, the combination of these tests did not lead to an improvement in test characteristics, with non-significant differences in positive predictive value (50.0 % [29.5–70.5] versus 80.0 % [37.3–96.4]) compared to PCr alone for pre-eclampsia development in one week. Conclusions: In addition to standard-of-care spot urine PCr measurements, this study has not been able to demonstrate that the sFlt-1/PlGF ratio cut-off 38 is of added value in the prediction of pre-eclampsia in multiple pregnancy. Show less
Berg, L.N. van den; Aardoom, J.J.; Kiveron, L.E.; Botterweg, R.D.; Akker-van Marle, M.E. van den; Chavannes, N.H.; Hoitsma, E. 2024
Background: Multiple sclerosis (MS) is a persistent inflammatory condition impacting the brain and spinal cord, affecting globally approximately 2.8 million individuals. Effective self-management... Show moreBackground: Multiple sclerosis (MS) is a persistent inflammatory condition impacting the brain and spinal cord, affecting globally approximately 2.8 million individuals. Effective self-management plays a crucial role in the treatment of chronic diseases, including MS, significantly influencing health outcomes. A personal health record (PHR) is a promising tool to support self-management, potentially empowering patients and enhancing their engagement in treatment and health. Despite these promising aspects, challenges in implementation persist and PHRs are still a relatively new concept undergoing rapid development.Objective: This study aimed to assess the feasibility and usability of the PHR. Secondary objectives included evaluating implementation determinants, and exploring preliminary effects on quality of care for both patients and healthcare professionals (HCPs), self-management, self-efficacy for patients, job satisfaction, efficiency, and demand for HCPs, and preliminary effects on costs and health-related quality of life.Methods: This study had a mixed-methods design. Quantitative data of patients (n = 80) and HCPs (n = 12) were collected via self-reported questionnaires at baseline (T0), after one year (T1), and after two years (T2). One focus group interview was conducted at T2 with patients (n = 7), and another one with HCPs (n = 4), to get a more in-depth understanding of the feasibility and usability of the PHR via the Unified Theory of Acceptance and Use of Technology framework, and to further explore the secondary objectives in-depth.Results: Most patients never logged in during the first year and logged in a couple of times per year during the second year, averaging around 15 min per log-in session. The HCPs mainly logged in a couple of times per year over the two years with an average use of six minutes per session. Patient usability and satisfaction scores were below average and moderate, respectively: with SUS-scores of 59.9 (SD = 14.2, n = 33) at T1 and 59.0 (SD = 16.3, n = 37) at T2, and CSQ-8 scores of 21.4 (SD = 5.0, n = 34) at T1, and 22.1 (SD = 5.0, n = 39) at T2. HCPs had similar usability and satisfaction scores. Multiple facilitators and barriers were identified by both patients and HCPs, such as (in)sufficient knowledge of how to use the PHR, lack of staff capacity and ICT obstacles. No significant differences were found in the preliminary effects. Qualitative data showed, among others, that both patients and HCPs saw the benefit of the PHR in terms of performance expectancy, by gaining more insight into health and health data, but challenges remained regarding effort expectancy, such as log-in issues and experiencing difficulties with information retrieval.Conclusion: The feasibility and usability were considered moderate by patients and HCPs; however, potential regarding the performance of the PHR was observed. Implementation challenges, such as the complexity of usage, lowered the adoption of the PHR. The evolving nature of PHRs requires ongoing evaluation and adaptation to optimize their potential benefits. Utilizing a participatory design approach and a dedicated implementation team could help in achieving this optimization, ultimately enhancing their adoption. Show less
Doornenbal, B.M.; Zutphen, T. van; Beumeler, L.F.E.; Vos, R.C.; Derks, M.; Haisma, H.; ... ; Kiefte-de Jong, J.C. 2024
Background The concept of Positive Health (PH) has gained increasing attention as a way of measuring individuals’ ability to adapt in the face of contextual challenges. However, a suitable... Show moreBackground The concept of Positive Health (PH) has gained increasing attention as a way of measuring individuals’ ability to adapt in the face of contextual challenges. However, a suitable measurement instrument for PH that encompasses contextual factors has not yet been developed. This paper responds to this need by developing a Context-specific Positive Health (CPH) measurement instrument that aligns with the Capability Approach (CA). Methods The measurement instrument was developed and tested among a representative sample of 1002 Dutch internet survey panel members with diverse sociodemographic backgrounds. The instrument was developed in two stages: a preparation phase consisting of focus groups and expert consultations, and a validation among a representative panel of Dutch citizens. The goal of the preparation phase, was to pilot test and refine previously proposed Positive Health questionnaires into an initial version of the CPHQ. The validation phase aimed to examine the initial CPHQ’s factorial validity using Factor Analysis, and its concurrent validity using Multivariate Regression Analysis. Results The developed questionnaire demonstrated adequate factorial and concurrent validity. Furthermore, it explicitly includes an assessment of resilience, this being a key component of PH. Conclusions The introduced measurement tool, the CPHQ, comprises 11 dimensions that we have labeled as follows: relaxation, autonomy, fitness, perceived environmental safety, exclusion, social support, financial resources, political representation, health literacy, resilience, and enjoyment. In this article, we present four major contributions. Firstly, we embedded the measurement in a theoretical framework. Secondly, we focused the questionnaire on a key concept of Positive Health - the “ability to adapt.” Thirdly, we addressed issues of health inequality by considering contextual factors. Finally, we facilitated the development of more understandable measurement items Show less
Straatmijer, T.; Akker-van Marle, M.E. van den; Ponsioen, C.Y.; Horst, D. van der; Scherpenzeel, M.P.M.; Duijvestein, M.; Meulen-de Jong, A.E. van der 2023
IntroductionSince the number of medical treatment options for Ulcerative Colitis (UC) has expanded over the last decades, patients and physicians face challenges regarding decisions about the... Show moreIntroductionSince the number of medical treatment options for Ulcerative Colitis (UC) has expanded over the last decades, patients and physicians face challenges regarding decisions about the medication options. We aimed to identify patients' preferences about their UC treatment options in the Netherlands. Furthermore, we assessed after how many failed treatment options, patients are willing to consider surgical treatment.MethodsWe conducted a web-based, multicenter, discrete choice experiment (DCE) among adult UC patients. Patients were repeatedly asked to choose between two hypothetical medicinal treatment options. The choice tasks were based on administration route, administration location, chance of symptom reduction (on short and long term) and chances on infection and other adverse events. Data were analyzed by using Hierarchical Bayes estimation.ResultsA total of 172 UC patients participated in the DCE. More than half were anti-TNF experienced (52.9%). The chance of symptom reduction after one year (relative importance (RI) 27.7 (95% CI 26.0-29.4)) was most important in choosing between medicinal treatments, followed by the chance of infection (RI 22.3 (21.4 - 23.3)) and chance of symptom reduction after eight weeks (RI 19.5 (18.3 - 20.6)). Considering surgical treatment, nineteen patients (14.3%) would not even consider surgery after failing eight treatment options without any new available therapies left. Nine patients would consider surgery before trying any treatment options.ConclusionWe found that symptom reduction after one year was the most important attribute in choosing between treatments in UC patients. These outcomes can help understand the trade-offs and preferences of UC patients. Show less
Jans, S.; Westra, X.; Crone, M.; Akker-van Marle, M.E. van den; Rijnders, M. 2023
IntroductionGroup antenatal care (gANC) is a group-based care-model combining routine antenatal care, with health assessment, education, and community building. GANC has shown positive results on... Show moreIntroductionGroup antenatal care (gANC) is a group-based care-model combining routine antenatal care, with health assessment, education, and community building. GANC has shown positive results on perinatal outcomes. However, midwives in Dutch primary care have reported higher costs when providing gANC. The purpose of this study was to assess the effect of replacing individual prenatal care (IC) by gANC on (expected future) health care costs and health outcomes.MethodsWe performed an exploratory cost-benefit analysis comparing costs and consequences of gANC with those of IC, using a hypothetical cohort of 12,894 women in gANC. Primary input data were derived from a stepped wedge cluster randomized controlled trial carried out in the Netherlands, assessing both health and psychosocial effects of gANC comparing them with IC. Other data was retrieved from available literature and an online questionnaire among midwifery practices. The main outcome measure was differential cost of gANC and lifetime direct healthcare costs related to the effects of gANC compared to IC (price level 2019).ResultsResults showed that gANC comes at a differential cost of €45 extra per person when compared to IC. However, projected healthcare cost-savings related to increased breastfeeding rates, reduced prevalence of pregnancy induced hypertension and less postpartum smoking, lead to an average net cost-savings of €67 per gANC participant.DiscussionAlthough gANC shows better health- and psychosocial outcomes when compared to IC, it is more costly to provide. However, findings indicate that the differential costs of gANC are off-set by long-term healthcare cost-savings. Show less
Bulk, S. van den; Petrus, A.H.J.; Willemsen, R.T.A.; Boogers, M.J.; Meeder, J.G.; Rahel, B.M.; ... ; Bonten, T.N. 2023
Introduction Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the... Show moreIntroduction Chest pain is a common reason for consultation in primary care. To rule out acute coronary syndrome (ACS), general practitioners (GP) refer 40%-70% of patients with chest pain to the emergency department (ED). Only 10%-20% of those referred, are diagnosed with ACS. A clinical decision rule, including a high-sensitive cardiac troponin-I point-of-care test (hs-cTnI-POCT), may safely rule out ACS in primary care. Being able to safely rule out ACS at the GP level reduces referrals and thereby alleviates the burden on the ED. Moreover, prompt feedback to the patients may reduce anxiety and stress.Methods and analysis The POB HELP study is a clustered randomised controlled diagnostic trial investigating the (cost-)effectiveness and diagnostic accuracy of a primary care decision rule for acute chest pain, consisting of the Marburg Heart Score combined with a hs-cTnI-POCT (limit of detection 1.6ng/L, 99th percentile 23ng/L, cut-off value between negative and positive used in this study 3.8ng/L). General practices are 2:1 randomised to the intervention group (clinical decision rule) or control group (regular care). In total 1500 patients with acute chest pain are planned to be included by GPs in three regions in The Netherlands. Primary endpoints are the number of hospital referrals and the diagnostic accuracy of the decision rule 24 hours, 6 weeks and 6 months after inclusion.Ethics and dissemination The medical ethics committee Leiden-Den Haag-Delft (the Netherlands) has approved this trial. Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses. Show less
Wind, M.; Akker-van Marle, M.E. van den; Ballieux, B.E.P.B.; Cobbaert, C.M.; Rabelink, T.J.; Lith, J.M.M. van; ... ; Sueters, M. 2022
Background: This study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia. Methods: This was a... Show moreBackground: This study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia. Methods: This was a prospective cohort study performed in a tertiary referral centre. Based on the combination of PCr (< 30) and sFlt-1/PlGF (& LE;38) results, four groups were described: a double negative result, group A-/-; a negative PCr and positive sFlt-1/PlGF, group B-/+; a positive PCr and negative sFlt-1/PlGF, group C+/-; and a double positive result, group D+/+. The primary outcome was the proportion of false negatives of the combined tests in comparison with PCr alone in the first week after baseline. Secondary, a cost analysis comparing the costs and savings of adding the sFlt-1/PlGF ratio was performed for different follow-up scenarios. Results: A total of 199 women were included. Pre-eclampsia in the first week was observed in 2 women (2%) in group A-/-, 12 (26%) in group B-/+, 4 (27%) in group C+/-, and 12 (92%) in group D+/+. The proportion of false negatives of 8.2% [95% CI 4.9-13.3] with the PCr alone was significantly reduced to 1.6% [0.4-5.7] by adding a negative sFlt-1/PlGF ratio. Furthermore, the addition of the sFlt-1/PlGF ratio to the spot urine PCr, with telemonitoring of women at risk, could result in a reduction of 41% admissions and 36% outpatient visits, leading to a cost reduction of euro46,- per patient. Conclusions: Implementation of the sFlt-1/PlGF ratio in addition to the spot urine PCr, may lead to improved selection of women at low risk and a reduction of hospital care for women with suspected pre-eclampsia. Show less
Wind, M.; Akker-van Marle, M.E. van den; Ballieux, B.E.P.B.; Cobbaert, C.M.; Rabelink, T.J.; Lith, J.M.M. van; ... ; Sueters, M. 2022
BackgroundThis study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia.MethodsThis was a... Show moreBackgroundThis study investigated the clinical value of adding the sFlt-1/PlGF ratio to the spot urine protein/creatinine ratio (PCr) in women with suspected pre-eclampsia.MethodsThis was a prospective cohort study performed in a tertiary referral centre. Based on the combination of PCr (< 30) and sFlt-1/PlGF (≤38) results, four groups were described: a double negative result, group A−/−; a negative PCr and positive sFlt-1/PlGF, group B−/+; a positive PCr and negative sFlt-1/PlGF, group C+/−; and a double positive result, group D+/+. The primary outcome was the proportion of false negatives of the combined tests in comparison with PCr alone in the first week after baseline. Secondary, a cost analysis comparing the costs and savings of adding the sFlt-1/PlGF ratio was performed for different follow-up scenarios.ResultsA total of 199 women were included. Pre-eclampsia in the first week was observed in 2 women (2%) in group A−/−, 12 (26%) in group B−/+, 4 (27%) in group C+/−, and 12 (92%) in group D+/+. The proportion of false negatives of 8.2% [95% CI 4.9–13.3] with the PCr alone was significantly reduced to 1.6% [0.4–5.7] by adding a negative sFlt-1/PlGF ratio. Furthermore, the addition of the sFlt-1/PlGF ratio to the spot urine PCr, with telemonitoring of women at risk, could result in a reduction of 41% admissions and 36% outpatient visits, leading to a cost reduction of €46,- per patient.ConclusionsImplementation of the sFlt-1/PlGF ratio in addition to the spot urine PCr, may lead to improved selection of women at low risk and a reduction of hospital care for women with suspected pre-eclampsia. Show less
Knol, R.; Brouwer, E.; Akker, T. van den; DeKoninck, P.L.J.; Lopriore, E.; Onland, W.; ... ; Pas, A.B. te 2022
Background International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However,... Show moreBackground International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However, clamping the cord prior to lung aeration may severely limit circulatory adaptation resulting in a reduction in cardiac output and hypoxia. Delaying cord clamping until lung aeration and ventilation have been established (physiological-based cord clamping, PBCC) allows for an adequately established pulmonary circulation and results in a more stable circulatory transition. The decline in cardiac output following time-based delayed cord clamping (TBCC) may thus be avoided. We hypothesise that PBCC, compared to TBCC, results in a more stable transition in very preterm infants, leading to improved clinical outcomes. The primary objective is to compare the effect of PBCC on intact survival with TBCC. Methods The Aeriation, Breathing, Clamping 3 (ABC3) trial is a multicentre randomised controlled clinical trial. In the interventional PBCC group, the umbilical cord is clamped after the infant is stabilised, defined as reaching heart rate > 100 bpm and SpO(2) > 85% while using supplemental oxygen < 40%. In the control TBCC group, cord clamping is time based at 30-60 s. The primary outcome is survival without major cerebral and/or intestinal injury. Preterm infants born before 30 weeks of gestation are included after prenatal parental informed consent. The required sample size is 660 infants. Discussion The findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management in very preterm infants at birth. Show less
Haspels, H.N.; Vries, M. de; Akker-van Marle, M.E. van den 2022
Purpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost... Show morePurpose Financial resources for health care are limited, so assessment of intervention effectiveness in terms of health in relation to its costs is important. Measuring health outcomes in cost-effectiveness analyses is usually done by health-related quality of life measures, like the EQ-5D. However, over the past decade, innovations on the conceptual level of health have evolved and novel approaches are rising such as the capability approach, subjective wellbeing, and Positive Health. This study assesses the psychometric properties of the subjective wellbeing-5 dimension (SWB-5D) outcome measure. Methods A quantitative, cross-sectional study design was used to determine the concurrent and construct (convergent and known group) validity for the SWB-5D. Concurrent and convergent validity were estimated as correlations between the SWB-5D and the Dutch version of the EQ-5D, ICECAP-A, and PH-17. Assessment of known-groups validity was based on the variables illness, education, and the overall happiness (Cantril Ladder) and overall health scale (EQ-5D VAS). Results A representative sample of 1016 respondents of the Dutch population completed an online questionnaire. The SWB-5D showed reasonable concurrent validity and showed good convergent and known-group validity. The SWB-5D had a lower ceiling effect compared to the EQ-5D and ICECAP-A. Conclusion Compared to traditional health measurement approaches, novel approaches are more focused on the mental and social pillars of health. The SWB-5D shows psychometric feasibility of comprehensive measurement of health, as indicated by a range of validity measures in a large representative sample of the Dutch population. Show less
Treskes, R.W.; Akker-van Marle, M.E. van den; Winden, L. van; Keulen, N. van; Velde, E.T. van der; Beeres, S.; ... ; Schalij, M.J. 2022
Background: Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care.Objective:... Show moreBackground: Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care.Objective: The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI).Methods: In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated.Results: Mean costs per patient were euro 2417 +/- 2043 (US $2657 +/- 2246) for the intervention and euro 2888 +/- 2961 (US $3175 +/- 3255) for the control group. This yielded a cost reduction of euro 471 (US $518) per patient. This difference was not statistically significant (95% CI - euro 275 to euro 1217; P=.22, US $-302 to $1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference -0.05, 95% CI -0.09 to -0.01; P=.01).Conclusions: eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. Show less
Rietbergen, T.; Marang-van de Mheen, P.J.; Graaf, J. de; Diercks, R.L.; Janssen, R.P.A.; Linden-van der Zwaag, H.M.J. van der; ... ; SMART Study Grp 2022
Purpose: To evaluate the effectiveness of a tailored intervention to reduce low value MRIs and arthroscopies among patients >= 50 years with degenerative knee disease in 13 Dutch orthopaedic... Show morePurpose: To evaluate the effectiveness of a tailored intervention to reduce low value MRIs and arthroscopies among patients >= 50 years with degenerative knee disease in 13 Dutch orthopaedic centers (intervention group) compared with all other Dutch orthopaedic centers (control group). Methods: All patients with degenerative knee disease >= 50 years admitted to Dutch orthopaedic centers from January 2016 to December 2018 were included. The tailored intervention included participation of clinical champions, education on the Dutch Choosing Wisely recommendation for MRI's and arthroscopies in degenerative knee disease, training of orthopaedic surgeons to manage patient expectations, performance feedback, and provision of a patient brochure. A difference-in-difference analysis was used to compare the time trend before (admitted January 2016-June 2017) and after introduction of the intervention (July 2017-December 2018) between intervention and control hospitals. Primary outcome was the monthly percentage of patients receiving a MRI or knee arthroscopy, weighted by type of hospital. Results: 136,446 patients were included, of whom 32,163 were treated in the intervention hospitals. The weighted percentage of patients receiving a MRI on average declined by 0.15% per month (beta = - 0.15, P < 0.001) and by 0.19% per month for arthroscopy (beta = - 0.19, P < 0.001). However, these changes over time did not differ between intervention and control hospitals, neither for MRI (beta = - 0.74, P = 0.228) nor arthroscopy (beta = 0.13, P = 0.688). Conclusions: The extent to which patients >= 50 years with degenerative knee disease received a MRI or arthroscopy declined significantly over time, but could not be attributed to the tailored intervention. This secular downward time trend may reflect anoverall focus of reducing low value care in The Netherlands. Show less
Staalduinen, D.J. van; Bekerom, P. van den; Groeneveld, S.; Kidanemariam, M.; Stiggelbout, A.M.; Akker-van Marle, M.E. van den 2022
Background: The aim of this study was to identify and summarize how value-based healthcare (VBHC) is conceptualized in the literature and implemented in hospitals. Furthermore, an overview was... Show moreBackground: The aim of this study was to identify and summarize how value-based healthcare (VBHC) is conceptualized in the literature and implemented in hospitals. Furthermore, an overview was created of the effects of both the implementation of VBHC and the implementation strategies used.Methods: A scoping review was conducted by searching online databases for articles published between January 2006 and February 2021. Empirical as well as non-empirical articles were included.Results: 1729 publications were screened and 62 were used for data extraction. The majority of the articles did not specify a conceptualization of VBHC, but only conceptualized the goals of VBHC or the concept of value. Most hospitals implemented only one or two components of VBHC, mainly the measurement of outcomes and costs or Integrated Practice Units (IPUs). Few studies examined effects. Implementation strategies were described rarely, and were evaluated even less.Conclusions: VBHC has a high level of interpretative variability and a common conceptualization of VBHC is therefore urgently needed. VBHC was proposed as a shift in healthcare management entailing six reinforcing steps, but hospitals have not implemented VBHC as an integrative strategy. VBHC implementation and effectiveness could benefit from the interdisciplinary collaboration between healthcare and management science. Show less
Staalduinen, D.J. van; Bekerom, P.E.A. van den; Groeneveld, S.M.; Kidanemariam, M.; Stiggelbout, A.M.; Akker-van Marle, M.E. van den 2022
Background: The aim of this study was to identify and summarize how value-based healthcare (VBHC) is conceptualized in the literature and implemented in hospitals. Furthermore, an overview was... Show moreBackground: The aim of this study was to identify and summarize how value-based healthcare (VBHC) is conceptualized in the literature and implemented in hospitals. Furthermore, an overview was created of the effects of both the implementation of VBHC and the implementation strategies used.Methods: A scoping review was conducted by searching online databases for articles published between January 2006 and February 2021. Empirical as well as non-empirical articles were included.Results: 1729 publications were screened and 62 were used for data extraction. The majority of the articles did not specify a conceptualization of VBHC, but only conceptualized the goals of VBHC or the concept of value. Most hospitals implemented only one or two components of VBHC, mainly the measurement of outcomes and costs or Integrated Practice Units (IPUs). Few studies examined effects. Implementation strategies were described rarely, and were evaluated even less.Conclusions: VBHC has a high level of interpretative variability and a common conceptualization of VBHC is therefore urgently needed. VBHC was proposed as a shift in healthcare management entailing six reinforcing steps, but hospitals have not implemented VBHC as an integrative strategy. VBHC implementation and effectiveness could benefit from the interdisciplinary collaboration between healthcare and management science. Show less
Metzemaekers, J.; Akker-van Marle, M.E. van den; Sampat, J.; Smeets, M.J.G.H.; English, J.; Thijs, E.; ... ; Essers, B. 2021
Objective To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. Design Labelled... Show moreObjective To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. Design Labelled discrete choice experiment (DCE). Setting Dutch academic and non-academic hospitals and online recruitment. Population or Sample A total of 169 women diagnosed with DE of the bowel. Methods Baseline characteristics and the fear of surgery were collected. Women were asked to rank attributes and choose between hypothetical conservative or surgical treatment in different choice sets (scenarios). Each choice set offered different levels of all treatment attributes. Data were analysed by using multinomial logistic regression. Main Outcome Measures The following attributes - effect on/risk of pain, fatigue, pregnancy, endometriosis lesions, mood swings, osteoporosis, temporary stoma and permanent intestinal symptoms - were used in this DCE. Results In the ranking, osteoporosis was ranked with low importance, whereas in the DCE, a lower chance of osteoporosis was one of the most important drivers when choosing a conservative treatment. Women with previous surgery showed less fear of surgery compared with women without surgery. Low anterior resection syndrome was almost equally important for patients as the chance of pain reduction. Pain reduction had higher importance than improving fertility chances, even in women with desire for a future child. Conclusions The risk of developing low anterior resection syndrome as a result of treatment is almost equally important as the reduction of pain symptoms. Women with previous surgery experience less fear of surgery compared with women without a surgical history. Tweetable Abstract First discrete choice experiment in patients with deep endometriosis. Show less
Brouwers, R.W.M.; Poort, E.K.J. van der; Kemps, H.M.C.; Akker-van Marle, M.E. van den; Kraal, J.J. 2021
IMPORTANCE Cardiac telerehabilitation (CTR) has been found to be a safe and beneficial alternative to traditional center-based cardiac rehabilitation (CR) and might be associated with higher... Show moreIMPORTANCE Cardiac telerehabilitation (CTR) has been found to be a safe and beneficial alternative to traditional center-based cardiac rehabilitation (CR) and might be associated with higher participation rates by reducing barriers to CR use. However, implementation of CTR interventions remains low, which may be owing to a lack of cost-effectiveness analyses of data from large-scale randomized clinical trials.OBJECTIVE To assess the cost-effectiveness of CTR with relapse prevention compared with centerbased CR among patients with coronary artery disease.DESIGN, SETTING, AND PARTICIPANTS This economic evaluation performed a cost-utility analysis of data from the SmartCare-CAD (Effects of Cardiac Telerehabilitation in Patients With Coronary Artery Disease Using a Personalized Patient-Centred ICT Platform) randomized clinical trial. The costeffectiveness and utility of 3 months of cardiac telerehabilitation followed by 9 months of relapse prevention were compared with the cost-effectiveness of traditional center-based cardiac rehabilitation. The analysis included 300 patients with stable coronary artery disease who received care at a CR center serving 2 general hospitals in the Netherlands between May 23, 2016, and July 26, 2018. All patients were entering phase 2 of outpatient CR and were followed up for 1 year (until August 14, 2019). Data were analyzed from September 21, 2020, to September 24, 2021.INTERVENTION After baseline measurements were obtained, participants were randomly assigned on a 1:1 ratio to receive CTR (intervention group) or center-based CR (control group) using computerized block randomization. After 6 supervised center-based training sessions, patients in the intervention group continued training at home using a heart rate monitor and accelerometer. Patients uploaded heart rate and physical activity data and discussed their progress during a weekly video consultation with their physical therapist. After 3 months, weekly coaching was concluded, and on-demand coaching was initiated for relapse prevention; patients were instructed to continue using their wearable sensors and were contacted in cases of nonadherence to the intervention or reduced exercise or physical activity volumes.MAIN OUTCOMES AND MEASURES Quality-adjusted life-years were assessed using the EuroQol 5-Dimension 5-Level survey (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS), and cardiac-associated health care costs and non-health care costs were measured by health care consumption, productivity, and informal care questionnaires (the Medical Consumption Questionnaire, the Productivity Cost Questionnaire, and the Valuation of Informal Care Questionnaire) designed by the Institute for Medical Technology Assessment. Costs were converted to 2020 price levels (in euros) using the Dutch consumer price index (to convert to US dollars, euro values were multiplied by 1.142, which was the mean exchange rate in 2020).RESULTS Among 300 patients (266 men [88.7%]), the mean (SD) age was 60.7 (9.5) years. The quality of life among patients receiving CTR vs center-based CR was comparable during the study according to the results of both utility measures (mean difference on EQ-5D-5L: -0.004; P =.82; mean difference on EQ-VAS: -0.001; P =.92). Intervention costs were significantly higher for CTR (mean [SE], (sic)224 [(sic)4] [$256 ($4)]) compared with center-based CR (mean [SE], (sic)156 [(sic)5] [$178 ($6)]; P <.001); however, no difference in overall cardiac health care costs was observed between CTR (mean [SE], (sic)4787 [(sic)503] [$5467 ($574)] and center-based CR (mean [SE], (sic)5507 [(sic)659] [$6289 ($753)]; P =.36). From a societal perspective, CTR was associated with lower costs compared with center-based CR (mean [SE], (sic)20 495 [(sic)2751] [$23 405 ($3142)] vs (sic)24 381 [(sic)3613] [$27 843 ($4126)], respectively), although this difference was not statistically significant (-(sic)3887 [-$ 4439]; P =.34).CONCLUSIONS AND RELEVANCE In this economic evaluation, a CTR intervention with relapse prevention was likely to be cost-effective compared with center-based CR, suggesting that CTR maybe used as an alternative intervention for the treatment of patients with coronary artery disease. These results add to the evidence base in favor of CTR and may increase the implementation of CTR interventions in clinical practice. Show less
Doornenbal, B.M.; Vos, R.C.; Vliet, M. van; Kiefte-De Jong, J.C.; Akker-van Marle, M.E. van den 2021
The definition of health has been shifting from disease absence to physical, emotional and social well-being. To demedicalise societal problems, the term Positive Health (PH) was introduced-a... Show moreThe definition of health has been shifting from disease absence to physical, emotional and social well-being. To demedicalise societal problems, the term Positive Health (PH) was introduced-a concept focused on the ability to adapt and to self-manage, in the face of physical, emotional and social challenges. The concept of PH receives broad attention, among others because a PH dialogue tool is intensively being used as a communication instrument while reflecting on patients' health, but a PH measurement instrument is not yet fully established. Recently, however, a 17-item PH measurement model was proposed. In this paper, a factor analysis and regression analyses were performed to test the factorial validity and concurrent validity of this PH measurement model based on a representative sample of the Dutch population (n = 1016, 50.0% women; age: from 15 until 39 = 29.8%, from 40 until 65 = 43.0%, older than 65 = 27.2%; education levels: low = 28.7%, medium = 42.6%, high = 28.7%). These tests are crucial to understand how well the PH measurement model is suitable as a measurement instrument. The factor analysis provided support for the factorial validity of the proposed PH measurement model. When comparing the proposed PH measurement model with domains of other measurements of health (i.e. BRS, HR-SWB, ICECAP, and EQ5D), to test the concurrent validity, the model explained more than half of the variance in measurements of the domains happiness (R-2 = 0.60) and overall self-rated health (R-2 = 0.57), but explained less than a quarter of the variance in measurements of autonomy (R-2 = 0.17 / R-2 = 0.13), personal growth (R-2 = 0.21), stability (R-2 = 0.20), self-care (R-2 = 0.15), and resilience (R-2 = 0.24). Two of the six domains of the PH measurement model-mental functioning and daily functioning-were weakly related to the other measurements of health. The results of this study imply that the PH measurement model is suitable to measure multiple dimensions of health. They also suggest that the PH measurement model may not be an encompassing measure for the concepts measured through other health measurements and might explain variance in health beyond these other measurements. Show less
Background: First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal... Show moreBackground: First-line treatment for prolactinomas is a medical treatment with dopamine agonists (DAs), which effectively control hyperprolactinaemia in most patients, although post-withdrawal remission rates are approximately 34%. Therefore, many patients require prolonged DA treatment, while side effects negatively impact health-related quality of life (HRQoL). Endoscopic transsphenoidal resection is reserved for patients with severe side effects, or with DA-resistant prolactinoma. Surgery has a good safety profile and high probability of remission and may thus deserve a more prominent place in prolactinoma treatment. The hypothesis for this study is that early or upfront surgical resection is superior to DA treatment both in terms of HRQoL and remission rate in patients with a non-invasive prolactinoma of limited size.Methods: We present a combined randomised clinical trial and observational cohort study design, which comprises three unblinded randomised controlled trials (RCTs; PRolaCT-1, PRolaCT-2, PRolaCT-3), and an observational study arm (PRolaCT-O) that compare neurosurgical counselling, and potential subsequent endoscopic transsphenoidal adenoma resection, with current standard care. Patients with a non-invasive prolactinoma (< 25 mm) will be eligible for one of three RCTs based on the duration of pre-treatment with DAs: PRolaCT-1: newly diagnosed, treatment-naive patients; PRolaCT-2: patients with limited duration of DA treatment (4-6 months); and PRolaCT-3: patients with persisting prolactinoma after DA treatment for > 2 years. PRolaCT-O will include patients who decline randomisation, due to e.g. a clear treatment preference. Primary outcomes are disease remission after 36 months and HRQoL after 12 months.Discussion: Early or upfront surgical resection for patients with a limited-sized prolactinoma may be a reasonable alternative to the current standard practice of DA treatment, which we will investigate in three RCTs and an observational cohort study. Within the three RCTs, patients will be randomised between neurosurgical counselling and standard care. The observational study arm will recruit patients who refuse randomisation and have a pronounced treatment preference. PRolaCT will collect randomised and observational data, which may facilitate a more individually tailored practice of evidence-based medicine. Show less
Objective: To study the experiences, considerations, and motivations of patients with endometriosis in the decision-making process for deep endometriosis (DE) treatment options.Design: Qualitative... Show moreObjective: To study the experiences, considerations, and motivations of patients with endometriosis in the decision-making process for deep endometriosis (DE) treatment options.Design: Qualitative study using semi-structured in-depth focus group methodology.Setting: University medical center.Patient(s): A total of 19 Dutch women diagnosed with DE between 27 and 47 years of age.Intervention(s): Not applicable.Main Outcome Measure(s): Focus group topics were disease impact and motives for treatment, expectations of the treatment process, and important factors in the decision process.Result(s): Women reported that pain, fertility, and strong fear of complications are important decisive factors in the treatment process. The goal of conceiving a child is considered important, however, sometimes doctors emphasize this topic too much. It emerged that complication counseling is frequently about surgical complications, whereas side effects of hormonal treatments are neglected. Shared decisionmaking and information about treatment options, complications, and side effects are not always optimal, making it difficult to make a well-considered choice. Despitenegative experiences encountered after surgery, the positive effect of surgery ensures that mostwomendonot regret their choice.Conclusion(s): In the treatment decision process for patients with DE, pain is almost always the most important decisive factor. The wish to conceive and strong fear of complications can change this choice. Doctors should understand the importance of fertility for the majority of women, but, also, if this is not considered paramount, respect that view. To improve shared decision making, exploration of treatment goals, training of healthcare providers, and better patient information provision are desirable. (C) 2020 by American Society for Reproductive Medicine. Show less
Ploeg, C.P.B. van der; Grevinga, M.; Eekhout, I.; Vlasblom, E.; Lanting, C.I.; Minderhout, H.M. van; ... ; Verkerk, P.H. 2021
Background: Little is known about costs and effects of vision screening strategies to detect amblyopia. Aim of this study was to compare costs and effects of conventional (optotype) vision... Show moreBackground: Little is known about costs and effects of vision screening strategies to detect amblyopia. Aim of this study was to compare costs and effects of conventional (optotype) vision screening, photoscreening or a combination in children aged 3-6 years. Methods: Population-based, cross-sectional study in preventive child health care in The Hague. Children aged 3 years (3y), 3 years and 9 months (3y9m) or 5-6 years (5/6y) received the conventional chart vision screening and a test with a photoscreener (Plusoptix 512C). Costs were based on test duration and additional costs for devices and diagnostic work-up. Results: Two thousand, one hundred and forty-four children were included. The estimated costs per child screened were (sic)17.44, (sic)20.37 and (sic)6.90 for conventional vision screening at 3y, 3y9m and 5/6y, respectively. For photoscreening, these estimates were (sic)6.61, (sic)7.52 and (sic)9.40 and for photoscreening followed by vision screening if the result was unclear (combination) (sic)9.32 (3y) and (sic)9.33 (3y9m). The number of children detected with amblyopia by age were 9, 14 and 5 (conventional screening), 6, 13 and 3 (photoscreening) and 10 (3y) and 15 (3y9m) (combination), respectively. The estimated costs per child diagnosed with amblyopia were (sic)1500, (sic)1050 and (sic)860 for conventional vision screening, (sic)860, (sic)420 and (sic)1940 for photoscreensic)ing and (sic)730 (3y) and (sic)450 (3y9m) for the combination. Conclusions: Combining photoscreening with vision screening seems promising to detect amblyopia in children aged 3y/3y9m, whereas conventional screening seems preferable at 5/6y. As the number of study children with amblyopia is small, further research on the effects of these screening alternatives in detecting children with amblyopia is recommended. Show less
