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Aim: In this study we aimed to assess the responsiveness of the symptom score of the recently developed Patient‐Reported Outcome Measure‐Haemorrhoidal Impact and Satisfaction Score (PROM‐HISS). Furthermore, the minimally relevant difference (MRD) was determined. Method: The responsiveness of PROM‐HISS was tested using a criterion‐based (i.e. anchor) and construct‐based (i.e. hypotheses testing) approach. Patients with haemorrhoidal disease (HD) completed the PROM‐HISS before and 1 week after treatment in hospital. A global self‐assessment of change question (SCQ) was administered 1‐week after treatment and functioned as the criterion. The following analyses were performed: (1) correlation between the PROM‐HISS symptom score and the criterion (SCQ) and (2) hypotheses testing. The MRD was determined as change in symptoms of the subgroup reporting 'somewhat fewer complaints' on the SCQ. Results: Between February and August 2022, 94 patients with grade II–IV HD from three hospitals were included. The correlation between the SCQ and a change on the PROM‐HISS symptom score was 0.595 indicating that an improvement on the SCQ corresponds to an improvement on the PROM‐HISS symptom score. As hypothesized, the mean change in PROM‐HISS scores was significantly different between subgroups of patients based on their SCQ responses. Patients reporting a small change in HD symptoms on the SCQ corresponded to a mean change of 0.3 on the PROM‐HISS symptom score. Conclusion: The PROM‐HISS symptom score is a responsive instrument as it identifies change in HD symptoms because of treatment. The estimated MRD of 0.3 can be used to inform clinical research and practice. [ABSTRACT FROM AUTHOR]

Personalising aftercare for curatively treated breast cancer patients is expected to improve patient satisfaction with care. A patient decision aid can support women in making decisions about their aftercare trajectory, but is currently not available. The aim of this study was to assess the needs of patients and health professionals with regard to an aftercare decision aid to systematically develop such a decision aid. Focus groups with patients and individual interviews with health professionals were digitally recorded and coded using the Framework analysis. Although most patients felt few aftercare options were available to them, health professionals reported to provide various options on the patients' request. Patients reported difficulty in expressing their need for options to their health professional. Although most patients were unfamiliar with decision aids, the majority preferred a paper‐based patient decision aid, while most health professionals preferred an online tool. The practical implications for the intended patient decision aid are: that a digital tool with paper‐based element should be developed, the patient decision aid should facilitate both rational and intuitive processes and should provide insight in patients' preferences concerning aftercare to discuss these explicitly. [ABSTRACT FROM AUTHOR]

The study’s aim was to estimate the societal costs of children with high-functioning ASD and comorbid anxiety disorder(s) (ASD + AD-group; n = 73), and to compare these costs to children with anxiety disorders (AD-group; n = 34), and typically developing children (controls; n = 87). Mean total costs for the ASD + AD-group amounted €17,380 per year. Societal costs were estimated at almost 142 million euro per year. Costs in the ASD + AD-group were four times higher compared to the AD-group, and 27 times higher compared to controls. ASD-related costs were higher in the ASD + AD-group; anxiety-related costs did not differ between the ASD + AD- and AD-group; costs due to physical or other reasons did not differ across groups. The findings suggest that costs can be decreased if effective treatment options for treating anxiety in ASD are established, however, the remaining costs associated with ASD would still be large. A limitation of the study is that a group of children with ASD without anxiety disorders is lacking. [ABSTRACT FROM AUTHOR]

Anxiety in children is highly frequent and causes severe dysfunction. Various studies have used screening procedures to identify high-anxious children and offer them indicated prevention, but the cost-effectiveness of these screening procedures in combination with a preventive intervention has never been examined. This study compared four potential strategies in relation to the prevention of child anxiety: (1) a one-time school-based screening which offers a child-focused intervention, (2) the screening and offering of a parent-focused intervention, (3) the screening and differentially offering a child- or parent-focused intervention, depending on whether or not the parents are anxious themselves, and (4) or doing nothing. An economic evaluation from a societal perspective (i.e. including direct healthcare costs, direct non-healthcare costs, indirect costs, and out-of-pocket costs), using a decision-analytic model. The model was based on the real-world 2-year participation rates of screening and intervention, and real-world costs and effects of high- and median-anxious children (aged 8-12) from regular primary schools. Incremental cost-effectiveness ratios were calculated, and several secondary and one-way sensitivity analyses were performed. The strategy of doing nothing and the strategy of screening and differentially offering the child- or parent-focused intervention, depending on parental anxiety levels were both worthwhile, with the latter strategy costing relatively little extra money compared to doing nothing. In conclusion, some evidence for the cost-effectiveness of screening and intervening was found. Screening and offering a parent-focused intervention to children of anxious parents, and a child-focused intervention to children of non-anxious parents, were found to be the most cost-effective approach. [ABSTRACT FROM AUTHOR]

Background: Despite a strong movement towards active patient involvement in healthcare policy decisions, systematic and explicit consideration of evidence of this research on patient preferences seems limited. Furthermore, little is known about the opinions of several stakeholders towards consideration of research evidence on patient preferences in healthcare policy decisions. This paper describes the protocol for an explorative study on the integration of research on patient preferences in healthcare policy decisions. The study questions: to what extent research evidence on patient preferences is considered in current procedures for healthcare policy decisions; opinions of stakeholders regarding the integration of this type of evidence in healthcare policy decisions; and what could be a decision framework for the integration of such research evidence in healthcare policy decisions. Methods/design: The study is divided in three sub-studies, predominantly using qualitative methods. The first sub-study is a scoping review in five European countries to investigate whether and how results of research on patient preferences are considered in current procedures for coverage decisions and clinical practice guideline development. The second sub-study is a qualitative study to explore the opinions of stakeholders with regard to the possibilities for integrating evidence on patient preferences in the process of healthcare decision-making in the Netherlands. The third sub-study is the development of a decision framework for research on patient preferences. The framework will consist of: a process description regarding the place of evidence on patient preferences in the decision-making process; and a taxonomy describing different terminologies and conceptualisations of 'preferences' and an overview of existing methodologies for investigating preferences. The concept framework will be presented to and discussed with experts. Discussion: This study will create awareness regarding the existence and potential value of research evidence on patient preferences for healthcare policy decision-making and provides insight in the methods for investigating patient preferences and the barriers and facilitators for integration of such research in healthcare policy decisions. Results of the study will be useful for researchers, clinical practice guideline developers, healthcare policy makers, and patient representatives. [ABSTRACT FROM AUTHOR]

Women who suffered from pregnancy complications are at increased risk for anxiety and depression. The aim of this study was to evaluate whether having suffered from preeclampsia (PE) or HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome is associated with anxiety and depression, and whether PE/ HELLP is an independent risk factor for developing anxiety and depression. Systematic search on PubMed and PsycInfo with no time limit. Studies presenting original data, including women with a history of PE/ HELLP and at least one comparison group of women without PE/ HELLP, reporting the results for each group separately or in a multivariate regression analysis with PE/ HELLP as an independent variable. Study characteristics and outcomes were extracted using a prespecified form. If necessary, additional calculations were performed. The search yielded 267 articles, with only six being suitable for inclusion in this review. Studies on depression (six studies) showed generally positive associations between PE/ HELLP and the prevalence of depression or severity of depressive symptoms. However, the results of three studies were not statistically significant. Studies addressing anxiety (two studies) did not show significant associations between PE/ HELLP and anxiety scores. Associations between post-traumatic stress and PE/ HELLP, investigated in four studies, were often nonsignificant. Due to heterogeneity of study methods, a meta-analysis of the results was not possible. In most studies, confounder control was poor. Evidence is mixed but generally points to positive associations between various forms of psychopathology and previous PE/ HELLP. Causality of the associations can, however, not be judged adequately. [ABSTRACT FROM AUTHOR]

Abstract: In this study, the cost-effectiveness of three indicated anxiety prevention strategies was examined from a societal perspective. Children (aged 8–12) were recruited via primary schools, selecting children scoring as high-anxious on an anxiety screening questionnaire. Participating children and their parents were randomized to a child – a parent-focused, or non-intervention group. All groups completed a diagnostic interview and standardized cost-diaries at pretest, and 1- and 2-year follow-up. Incremental cost-effectiveness ratios per ‘ADIS improved’ child (based on diagnostic information) were calculated and cost-effectiveness acceptability curves and frontiers were plotted. The base-case and most secondary analyses showed it would be cost-effective to offer high-anxious children an intervention, and the parent-focused intervention to be the optimal strategy at lower monetary threshold values than the child-focused intervention and when parents were anxious. The child-focused intervention was dominant when analyses were performed from a healthcare perspective, for boys, and for children of grades 7–8 of primary school. [Copyright &y& Elsevier]

Basal cell carcinoma (BCC) is a slowly growing nonmelanoma type of skin cancer that often is located on the face. Different therapies are available to treat BCC, of which surgical excision (SE) and Mohs micrographic surgery (MMS) are the most frequently used surgical procedures. To examine which attributes of a surgical treatment the general public values as important and to determine the incremental willingness to pay for MMS versus SE. A discrete-choice experiment (DCE) was conducted among members of the general public to examine which attributes of a surgical treatment for primary BCC are valued as important. In addition, based on the attributes included in the experiment, the willingness to pay for MMS versus SE was determined. Respondents ( N=312) preferred a treatment with a lower recurrence rate, shorter surgery time, shorter travelling time, shorter waiting time, no risk for re-excision, and lower cost. The incremental willingness to pay for MMS was 847 euro ($1,203). Results from this DCE indicate that, when outcome and process attributes are considered from a societal perspective, MMS is preferred over SE for primary BCC. The authors have indicated no significant interest with commercial supporters. [ABSTRACT FROM AUTHOR]

Background. Short stay (admission, surgery, and discharge the same day or within 24 hours) following breast cancer surgery is part of an established care protocol but as yet not well implemented in Europe. Alongside a before-after multi-centre implementation study, an economic evaluation was performed exploring the cost-effectiveness of a short stay programme (SSP) versus care as usual (CAU). Material and methods. In the implementation study, 324 patients were included. In the economic evaluation a societal perspective was applied with a six week time horizon. Cost data were obtained from Case Record Forms and cost diaries. Effectiveness was assessed by calculating Quality Adjusted Life Years (QALYs), using the EuroQol-5D. Cost-effectiveness was expressed as the incremental costs per QALY. Results. Mean societal costs decreased by €955,- (95% CI € - 2104,- to €157,-) for patients in SSP (n=127) compared with CAU (n=135). Mean healthcare costs differed €883,- (95% CI € - 1560,- to €870,-) in favour of SSP. The incremental cost-effectiveness ratio could not be calculated due to similar effectiveness for both groups, i.e. the difference in QALYs was zero. The cost-effectiveness acceptability curves showed that the probability that SSP was more cost-effective than CAU was over 90% in the base-case analysis. Discussion. A short stay programme as implemented is cost-effective compared with care as usual. In achieving good and more efficient quality of care, larger scale implementation is warranted. [ABSTRACT FROM AUTHOR]

Background/aim: The EQ-5D is a generic health-related quality of life (HRQoL) measure that is used for the purpose of economic evaluations of health interventions. Therefore, it has to be responsive to meaningful changes in health in the patient population under investigation. The aim of this study was to investigate the responsiveness of the EQ-5D in breast cancer patients in their first year after treatment. Methods: The subscale global health of the disease-specific HRQoL measure EORTC QLQ-C30 was used as a reference instrument to determine meaningful changes in health and identify subgroups of patients: patients reporting a moderate-large deterioration, small deterioration, a small improvement, moderate-large improvement, or no change in health status. Responsiveness was evaluated by calculating standardized response means (SRMs) in the five subgroups of patients and performing analysis of variance procedures. The two HRQoL measures were filled out two weeks and one year after finalizing curative treatment for breast cancer (n = 192). Results: The EQ-5D was able to capture both improvements and deteriorations in HRQoL. SRMs of the EQ VAS and EQ-5D Index were close to zero in the subgroup reporting no change and increased and decreased adequately in the subgroups reporting small and moderate changes. Additional analysis of variance procedures showed that the EQ-5D was able to differentiate between subgroups of patients with no change and moderate-large deterioration or improvement in health. Conclusion: The EQ-5D seems an appropriate measure for the purpose of economic evaluations of health intervention in breast cancer patients after treatment. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the cost-effectiveness of family cognitive-behavioral therapy (CBT) compared with individual CBT in children with anxiety disorders. Clinically anxious children (aged 8-18 years) referred for treatment were randomly assigned to family or individual CBT and were assessed pre-treatment, post treatment, and at 3 months and 1 year after treatment. Cost effectiveness ratios were calculated expressing the incremental costs per anxietyfree child and the incremental costs per Quality Adjusted Life Year (QALY) for the referred child. Neither societal costs nor effectiveness were significantly different between individual and family CBT. However, the point estimates of the cost-effectiveness ratios resulted in dominance for individual CBT, indicating that individual CBT is more effective and less costly than family CBT. These results were confirmed by bootstrap analyses and cost-effectiveness acceptability curves. Several secondary and sensitivity analyses showed that the results were robust. It can be concluded that family CBT is not a cost-effective treatment for clinically anxious children, compared with individual CBT. [ABSTRACT FROM AUTHOR]

Objectives: In trial-based analyses, the Human Capital (HC) approach is currently applied alternately with and without the incorporation of productivity costs for persons who are work disabled at baseline of the trial. We call these methods HC-extended (HCEXT) and HC-limited (HCLIM), respectively. Aim of the paper is to compare productivity costs according to HCEXT with HCLIM and the Friction Cost (FC) method, in patients with Borderline Personality Disorder (BPD). Methods: Data were obtained from a multicenter randomized trial in The Netherlands, comparing two types of outpatient psychotherapy, Schema Focused Therapy (SFT, n = 44) versus Transference Focused Psychotherapy (TFP, n = 42) for BPD. Mean age was 31.7 for SFT and 29.5 for TFP. A cost-interview was administered every three months for three years, and once again after the fourth year. Productivity costs were calculated according to HCLIM, HCEXT and FC. A nonparametric bootstrap resampling method was performed. Results: During the trial, the number of work-disabled patients increased for both treatments. Total productivity costs for HCEXT were higher than for HCLIM and FC. In addition, the incremental bootstrapped costs (TFP − SFT) pointed in the same direction for HCLIM (&U20AC;1168; 95% UI &U20AC;4700, &U20AC;7563) and FC (&U20AC;1206; −&U20AC;2835, &U20AC;4844), but turned around for HCEXT(minus &U20AC;1240; −&U20AC;9973, &U20AC;7911). None of the increments were statistically significantly different from zero. Conclusions: The classical and frequently discussed contrast between HC and FC is not the only difference when it concerns productivity costs. Whether or not including productivity costs for patients who are work-disabled at baseline can lead to contradictory conclusions. [ABSTRACT FROM AUTHOR]

A prevalence-based cost-of-illness study using a societal perspective was conducted to investigate the cost-of-illness in clinically anxious youth aged 8-18 in The Netherlands. Discriminant validity of the cost diary used was obtained by comparing costs of families with an anxious child (n = 118) to costs of families from the general population (n = 41). To examine the convergent validity, bottom-up acquired costs derived from cost diaries were compared to top-down acquired costs obtained from national registrations. Bottom-up acquired costs measured by means of cost diaries amounted to Euro 2,748 per family of a clinically referred anxious child per annum. Societal costs of families with clinically anxious children were almost 21 times as high compared to families from the general population. With respect to convergent validity, total health care costs using the bottom-up approach from clinically anxious children were quite comparable to those of top-down data of anxious children, although costs within the subcategories differed considerably. Clinical anxiety disorders in childhood cost the Dutch society more than 20 million euros a year. Based on results of discriminate and convergent validity, the cost diary seems a valid method in establishing cost-of-illness in childhood anxiety disorders. [ABSTRACT FROM AUTHOR]

Background: The EQ-5D is a reliable tool for measuring Health-Related Quality of Life (HRQoL). However, concern has been expressed that it may ignore elements of HRQoL, particularly cognition. In response to this concern, the EQ-5D has been extended with a cognitive dimension (EQ-5D+C). The aim of this study was to compare the performance of the EQ-5D and the EQ- 5D+C in elderly patients with cognitive impairments by assessing their construct validity and responsiveness. Methods: Data from the MEDICIE study (n = 196) were used, in which all questionnaires were rated by proxies. Results: Regarding construct validity, we found similar correlations between the EQ-5D and the Mini Mental State Examination (MMSE) and between the EQ-5D+C and the MMSE. Furthermore, both the EQ-5D and the EQ-5D+C were responsive to changes in the MMSE, with the EQ-5D performing slightly better. Conclusion: We conclude that the EQ-5D performs well for evaluating HRQoL in a population with cognitive impairments. Based on the results of this explorative study, it does not seem necessary to adjust the current classification system by adding a cognitive dimension. However, in order to compare both instruments regarding utility values, it is necessary to develop a new scoring algorithm for the EQ-5D+C by conducting a general population study. Considering the explorative nature of this study, it is recommended that more aspects of the validity of both the EQ-5D and the EQ-5D+C are explored in patients with cognitive impairments using a more tailored study design. [ABSTRACT FROM AUTHOR]

BackgroundThe impact of dementia constitutes a major public health challenge to our society. A multidisciplinary approach to dementia is generally recommended. ObjectiveThe objective of this review is to give an overview of the reported empirical studies on the added value of a multidisciplinary approach to diagnosing dementia, i.e. whether differences can be found between diagnostic multidisciplinary approaches, and/or monodisciplinary ones with respect to the diagnostic outcomes, the impact of diagnostics and their effects on quality of life and costs. MethodCritical review of studies which involve a multidisciplinary assessment of dementia. Literature was systematically searched in a number of international databases (Medline, PsychInfo, Pubmed and EconLit). A first selection was based on screening titles by one author. Interrater reliability was determined by scoring all abstracts by two authors. The reliability of selecting full articles was based on scoring a random sample by two authors. Kappa values were calculated. The Kappa statistic (k) was also used as an indicator of the diagnostic agreement between single disciplines and multidisciplinary teams. ResultsFive studies were identified as relevant for the purpose of this review. The most important outcome was the level of diagnostic agreement between single disciplines and multidisciplinary teams (MTs). Overall, there was substantial agreement (kappa: 0.37–0.76) on the diagnosis dementia (syndrome), but not on the subtypes (aetiology) (AD: 0.26–0.60; VD: 0.35–0.52; depression: 0.30–0.46). Diagnoses also differed between the disciplines. ConclusionsMerely studies on diagnostic accuracy were found, all using different reference standards. Kappa values were chosen as outcome measure and every diagnosis was considered of equal value. Therefore, the added value could not definitively be demonstrated. However, the potential added value of a multidisciplinary approach to diagnosing dementia probably lies in the ability to differentiate among the subtypes of dementia and to detect comorbid psychiatric conditions such as depression. Disciplines within an MT complement each other in establishing a specific diagnosis, which is considered to be the added value of such a multidisciplinary team. Copyright © 2006 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

To determine the costs associated with the diagnostic work-up and percutaneous revascularization of renal artery stenosis from various perspectives. A prospective multicenter comparative study was conducted between 1998 and 2001. A total of 402 hypertensive patients with suspected renal artery stenosis were included. Costs were assessed of computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA), and percutaneous revascularization. From the societal perspective, DSA was the most costly (euro 1,721) and CTA the least costly diagnostic technique (euro 424). CTA was the least costly imaging procedure irrespective of the perspective used. The societal costs associated with percutaneous renal artery revascularization ranged from euro 2,680 to euro 6,172. Overall the radiology department incurred the largest proportion of the total societal costs. For the management of renal artery stenosis, performing the analysis from different perspectives leads to the same conclusion concerning the least costly diagnostic imaging and revascularization procedure. [ABSTRACT FROM AUTHOR]

Although the disease burden of coloproctological complaints on a patient level may be limited, the disease burden on a population level is huge; the same holds true regarding the economic burden [4]. If compared with the prevalence figures of patients having Inflammatory Bowel Disease (IBD), ranging around 0.3%, the former is a noticeably larger group [2]. This venture was underwritten by the ESCP in the publication of a Core Outcome Set (COS) for HD; in this COS, "patient-reported symptoms" was the item selected as the primary outcome [5]. [Extracted from the article]

Objective: To compare the effectiveness of open and laparoscopic primary inguinal hernia repair. Design: Randomised controlled trial. Setting: University hospital, The Netherlands. Subjects: 87 patients had 103 open repairs and 88 patients had 114 laparoscopic repairs between November 1993 and July 1995. Interventions: Laparoscopic repair by the transabdominal preperitoneal (TAPP) technique and open repair by the Bassini technique. Main outcome measures: Recurrence, morbidity, pain, and duration of convalescence. Results: Operating time was longer for laparoscopy (mean (SD): 82 (28) compared with 45 (15) minutes p < 0.001). Patients in the Bassini group had higher postoperative painscores (mean (SD)VAS: 2.9 (1.6) compared with 2.0 (1.6) p = 0.002), used more analgesics (median total intake: 2 (0–54) compared with 0 tablets (0–42) p = 0.008), and needed a longer convalescence time (mean (SD) time to return to work: 22 (12.6) compared with 14 (10.1) days p < 0.001; mean (SD) time to return to physical activities: 27 (12.6) compared with 17 (12.2) days p < 0.001). Mean follow up was 24 months. Recurrence rates were 21% (22/103) after Bassini and 6% (7/114) after laparoscopic repair (p = 0.001). Conclusion: Laparoscopic hernia repair is a safe operation, which has obvious advantages over the Bassini repair in terms of pain, use of analgesic drugs, resumption of activities, and recurrence. A disadvantage of the laparoscopic repair is the longer operating time. [ABSTRACT FROM AUTHOR]

Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. ClinicalTrials.gov identifier: NCT04101773 • There is a lack of consensus on the treatment of recurrent haemorrhoidal disease • A randomized controlled trial is the gold standard for effectiveness research • This study aims to provide high-level evidence on the comparative (cost)effectiveness of three generally accepted treatments. [ABSTRACT FROM AUTHOR]

Aim: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost‐effectiveness of SNM in children and adults with refractory idiopathic slow‐transit constipation (STC). Method: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost‐effectiveness outcomes, trial‐ and model‐based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost‐effectiveness outcomes were, respectively, adverse events and incremental cost‐effectiveness ratios. Results: Of 1390 records reviewed, 67 studies were selected for full‐text screening. For effectiveness, one cross‐over and one parallel‐group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial‐based economic evaluation was included, which concluded that SNM was not cost‐effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. Conclusion: Evidence for the (cost‐)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported. [ABSTRACT FROM AUTHOR]

Breathlessness is one of the most frequent symptoms in chronic obstructive pulmonary disease (COPD). COPD may result in disability, decreased productivity and increased healthcare costs. The presence of comorbidities increases healthcare utilization. However, the impact of breathlessness burden on healthcare utilization and daily activities is unclear. This study's goal was to analyze the impact of breathlessness burden on healthcare and societal costs. In this observational single-center study, patients with COPD were followed-up for 24 months after completion of a comprehensive pulmonary rehabilitation program. Every three months participants completed a cost questionnaire, covering healthcare utilization and impact on daily activities. The results were compared between participants with low (modified Medical Research Council (mMRC) grade <2; LBB) and high baseline breathlessness burden (mMRC grade ≥2; HBB). Healthcare costs in year 1 were €7302 (95% confidence interval €6476–€8258) for participants with LBB and €10,738 (€9141–€12,708) for participants with HBB. In year 2, costs were €8830 (€7372-€10,562) and €14,933 (€12,041–€18,520), respectively. Main cost drivers were hospitalizations, contact with other healthcare professionals and rehabilitation. Costs outside the healthcare sector in year 1 were €682 (€520–€900) for participants with LBB and €1520 (€1210–€1947) for participants with HBB. In year 2, costs were €829 (€662–€1046) and €1457 (€1126–€1821) respectively. HBB in patients with COPD is associated with higher healthcare and societal costs, which increases over time. This study highlights the relevance of reducing costs with adequate breathlessness relief. When conventional approaches fail to improve breathlessness, a personalized holistic approach is warranted. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in patients without diabetes. Setting: Seven ophthalmology clinics in the Netherlands and Belgium. Design: Prospective cost-effectiveness analysis using data from a European multicenter randomized clinical trial (ESCRS PREMED). Methods: Patients without diabetes planned for expected uneventful cataract surgery were randomized to topical bromfenac (Yellox, n = 242), topical dexamethasone (n = 242), or a combination treatment (n = 238). All relevant resources from a healthcare perspective were included in the cost analysis within a time horizon of 12 weeks postoperatively. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) based on the cost per QALY. Results: The study comprised 722 patients without diabetes. Total healthcare costs and QALYs were [Euro sign] 447 (US $562) and 0.174 in the bromfenac group, [Euro sign]421 (US $529) and 0.179 in the dexamethasone group, and [Euro sign]442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was [Euro sign]6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is [Euro sign] 20 000 (US $25 126) per QALY, the cost-effectiveness probability was 3%, 32%, and 65% in the bromfenac, dexamethasone, and combination groups, respectively. Conclusions: In patients without diabetes, combination treatment with topical bromfenac and dexamethasone was effective and cost-effective in preventing CME after cataract surgery compared with treatment with either drug alone. [ABSTRACT FROM AUTHOR]

Objectives: For older people who worry about their memory, their general practitioner (GP) is often the first healthcare professional they turn to. This study aims to increase knowledge of GPs' daily practice on diagnostic strategies for patients who present themselves with memory complaints and/or worries about dementia for the first time in general practice and to explore associations of patients' characteristics with these strategies. Method: Retrospective observational study using electronic patient records from patients presenting with memory complaints between 2012 and 2019. The patient records are derived from a Dutch primary care registration network. The decision on diagnostic strategy was extracted and categorized as (1) wait and see, (2) diagnostic testing in primary care, or (3) referral. Patient characteristics (gender, age, general practice, level of comorbidities, chronic polypharmacy, and the number of consultations on memory complaints), fear of developing dementia, and information on why the first consultation on memory complaints was scheduled were extracted. Results: A total of 228 patients were included. Most patients were cared for within primary care, either for further primary care diagnostics (56.1%) or because a wait‐and‐see strategy was pursued (14.9%). One‐third (28.9%) of patients were referred. Differences between diagnostic strategies in patient characteristics, fear of developing dementia, or reason for first consultation between these diagnostic strategies were not found, nor were these variables predictive of referral. Conclusion: Most Dutch patients with memory complaints and/or worries about dementia who seek help from their GP for the first time are cared for in the primary care setting for the following 6 months. The lack of association between included patient characteristics and diagnostic strategies highlights the complexity of the decision‐making process on diagnostic testing for dementia in general practice. Key points: Most Dutch patients who seek help for memory complaints from their general practitioner (GP) for the first time are not referred for specialized diagnostic testing, which underlines the crucial and gatekeeper role GPs play in the management and care for this patient group.Previous qualitative research indicates that GPs consider patient characteristics important in decisions on diagnostic trajectories for memory complaints. Retrospective data from the studied electronic patient records, however, indicates that patient characteristics such as age and comorbidity do not differ between diagnostic strategies nor are they predictive for referrals.Further unraveling of the complex decision‐making process for diagnostic testing for dementia is needed to facilitate timely dementia diagnoses. [ABSTRACT FROM AUTHOR]

Background This study aims to provide greater insight into the current decision-making process on diagnostic testing for dementia by exploring the expectations, needs and experiences of patients with memory complaints, significant others and general practitioners (GPs). Methods We performed semi-structured interviews with patients (>60 years) who consulted their GP on memory complaints, significant others and GPs. Participants were recruited until data saturation was reached in thematic analysis of interview transcripts. Results We performed 51 interviews (patients n  = 20, significant others n  = 15, GPs n  = 16). Thematic analysis revealed four themes: (i) 'drivers to (not) testing', i.e. need to act on symptoms, beliefs on the necessity and expected outcomes of diagnostic testing; (ii) 'patient preferences and context are critical in the actual decision', i.e. in the actual decision-making process interpretation of symptoms, GPs' desire to meet patient preferences, social context and healthcare system dynamics guided the decision; (iii) 'need for individualised communication in the decision-making process', i.e. for patients feeling heard was a prerequisite for decision-making and GPs tailored communication strategies to individual patients and (iv) 'GP practice and barriers to shared decision-making (SDM)', i.e. although GPs value SDM in the decision on diagnostic testing for dementia, patients express limited awareness of the decision and options at stake. Conclusions Decision-making on diagnostic testing for dementia is a multifactorial and preference-guided process for all involved stakeholders, but decisions are often not explicitly jointly made. Development of patient decision aids could facilitate better involvement and more informed choices by patients. [ABSTRACT FROM AUTHOR]

Background: As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events. Methods/design: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months. Discussion: PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice. Trial registration: ClinicalTrials.gov NCT05703230. Registered on 11/09/2022. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to translate the Dutch patient‐reported outcome measure‐haemorrhoidal impact and satisfaction score (PROM‐HISS) to English and perform a cross‐cultural validation. Method: The ISPOR good practice guidelines for the cross‐cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM‐HISS. Results: Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM‐HISS was reached. Interviews were conducted with 10 native English‐speaking HD patients (30% female), with a mean age of 44 years (24–83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM‐HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics. Conclusion: The translated English language PROM‐HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment. [ABSTRACT FROM AUTHOR]

In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness. We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of –5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number NCT03400124 , and is now closed for recruitment. Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was –1% (90% CI –3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500–80 000 (US$3145–100 629) per quality-adjusted life-year. Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied. Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society. [ABSTRACT FROM AUTHOR]

To explore the preferences of people with memory complaints (PwMC) and their significant others regarding starting a diagnostic trajectory for dementia. A systematic literature search was conducted in PubMed, PsycINFO, CINAHL, Web of Science, and Embase. Selection of abstracts and papers was performed independently by two researchers. Methodological quality was assessed with the Mixed Method Appraisal Tool. Result sections of the selected papers were thematically synthesized. From 2497 citations, seven qualitative studies and two mixed methods studies published between 2010 and 2020 were included. Overall quality of the studies was high to moderate. A thematic synthesis showed that preferences for starting a diagnostic trajectory arose from the feeling of needing to do something about the symptoms, beliefs on the necessity and expected outcomes of starting a diagnostic trajectory. These views were influenced by normalization or validation of symptoms, the support or wishes of the social network, interactions with health care professionals, the health status of the PwMC, and societal factors such as stigma and socioeconomic status. A variety of considerations with regard to decision-making on starting a diagnostic trajectory for dementia were identified. This emphasizes the need to explore individual preferences to facilitate a timely dementia diagnosis. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the cost‐effectiveness of Descemet Membrane Endothelial Keratoplasy (DMEK) versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT‐DSAEK). Methods: A cost‐effectiveness analysis using data from a multicenter randomized clinical trial was performed. The time horizon was 12 months postoperatively. Patients with Fuchs' endothelial dystrophy were randomized to DMEK (n = 29) or UT‐DSAEK (n = 24). Relevant resources from healthcare and societal perspectives were included in the cost analysis. Quality‐Adjusted Life Years (QALYs) were determined using the Health Utilities Index Mark 3 (HUI3) and the EuroQol EQ‐5D‐5L questionnaires. The main outcome was the incremental cost‐effectiveness ratio (ICER; incremental societal costs per QALY). Results: Societal costs averaged €8851 (US$11 406) for DMEK and €8320 (US$10 722) for UT‐DSAEK. Higher costs in the DMEK group were mainly caused by higher rebubbling and regraft rates (21% and 7%, vs. 4% and 0% in the UT‐DSAEK group). HUI3 QALYs were 0.70 (DMEK) and 0.79 (UT‐DSAEK). EQ‐5D‐5L QALYs were 0.83 (DMEK) and 0.86 (UT‐DSAEK). The ICER indicated DMEK was dominated by UT‐DSAEK in both analyses. The cost‐effectiveness probability for DMEK ranged from 21% to 5% (HUI3 QALYs) and 27%–14% (EQ‐5D‐5L QALYs), assuming the maximum acceptable ICER ranged from €2500 to €80.000 (US$3222–US$103 093) per QALY. Conclusion: The base case cost‐effectiveness analysis favoured UT‐DSAEK over DMEK, as costs of DMEK were higher while QALYs were lower. Further studies are required to assess long‐term rebubbling and regraft rates and graft survival. [ABSTRACT FROM AUTHOR]

Background: Expected rise in the demand for healthcare and a dropping supply of healthcare professionals, has generated an increased interest in the most effective deployment of healthcare professionals. Consequently, task shifting has become a common strategy to redistribute tasks between established professional groups, however, little is known about the effects of shifting tasks to emerging professional groups. The aim of this study was to evaluate a legal amendment to facilitate task shifting to an emerging profession in Dutch healthcare: Clinical Technologists (CTs). CTs were introduced and provided an Extended Scope of Practice (ESP) to perform nine 'reserved procedures' independently. Methods: A concurrent multi-phase mixed methods study was used to evaluate whether a legal amendment to facilitate task shifting to CTs was effective and efficient. Results: The results show that CTs use their ESP frequently to perform five categories of reserved procedures independently and suggest that the ESP increased the efficiency of care delivery for those procedures. Additionally, the findings highlight that task shifting was influenced by the setting in which CTs worked, time allotted to patient-contact as well as external factors (e.g., financing). Conclusions: This study provides tentative lessons for policymakers on how task shifting to emerging professional groups can be improved. Providing a legal amendment to facilitate task shifting to CTs seems to be effective and efficient. However, it also poses multiple challenges. While established professional groups can face similar challenges, it is likely that these are exacerbated for emerging professional groups, particularly when shifting tasks occurs horizontally. [ABSTRACT FROM AUTHOR]

Background: Despite a strong movement towards active patient involvement in healthcare policy decisions, systematic and explicit consideration of evidence of this research on patient preferences seems limited. Furthermore, little is known about the opinions of several stakeholders towards consideration of research evidence on patient preferences in healthcare policy decisions. This paper describes the protocol for an explorative study on the integration of research on patient preferences in healthcare policy decisions. The study questions: to what extent research evidence on patient preferences is considered in current procedures for healthcare policy decisions; opinions of stakeholders regarding the integration of this type of evidence in healthcare policy decisions; and what could be a decision framework for the integration of such research evidence in healthcare policy decisions.Methods/design: The study is divided in three sub-studies, predominantly using qualitative methods. The first sub-study is a scoping review in five European countries to investigate whether and how results of research on patient preferences are considered in current procedures for coverage decisions and clinical practice guideline development. The second sub-study is a qualitative study to explore the opinions of stakeholders with regard to the possibilities for integrating evidence on patient preferences in the process of healthcare decision-making in the Netherlands. The third sub-study is the development of a decision framework for research on patient preferences. The framework will consist of: a process description regarding the place of evidence on patient preferences in the decision-making process; and a taxonomy describing different terminologies and conceptualisations of 'preferences' and an overview of existing methodologies for investigating preferences. The concept framework will be presented to and discussed with experts.Discussion: This study will create awareness regarding the existence and potential value of research evidence on patient preferences for healthcare policy decision-making and provides insight in the methods for investigating patient preferences and the barriers and facilitators for integration of such research in healthcare policy decisions. Results of the study will be useful for researchers, clinical practice guideline developers, healthcare policy makers, and patient representatives. [ABSTRACT FROM AUTHOR]

Background: The cesarean section (CS) rate has increased over recent decades with poor guideline adherence as a possible cause. The objective of this study was to explore barriers and facilitators for delivering optimal care as described in clinical practice guidelines.Methods: Key recommendations from evidence-based guidelines were used as a base to explore barriers and facilitators for delivering optimal CS care in The Netherlands. Both focus group and telephone interviews among 29 different obstetrical professionals were performed. Transcripts from the interviews were analysed. Barriers and facilitators were identified and categorised in six domains according to the framework developed by Grol: the guideline recommendations (I), the professional (II), the patient (III), the social context (IV), the organizational context (V) and the financial/legislation context (VI).Results: Most barriers were found in the professional and organizational domain. Barriers mentioned by healthcare professionals were disagreement with specific guideline recommendations, and hesitation to allow women to be part of the decision making process. Other barriers are lack of adequately trained personal staff, lack of collaboration between professionals, and lack of technical equipment.Conclusions: Clear facilitators and barriers for guideline adherence were identified in all domains. Several barriers may be addressed by using decision aids on mode of birth or prediction models to individualise care in women in whom both planned vaginal birth and CS are equal options. In women with an intended vaginal birth, adequate staffing and the availability of both fetal blood sampling and epidural analgesia are important. [ABSTRACT FROM AUTHOR]

Objectives. To estimate the preferences of osteoporotic patients for medication attributes, and analyse data from seven European countries. Methods. A discrete choice experiment was conducted in Belgium, France, Ireland, the Netherlands, Spain, Switzerland and the UK. Patients were asked to choose repeatedly between two hypothetical unlabelled drug treatments (and an opt-out option) that varied with respect to four attributes: efficacy in reducing the risk of fracture, type of potential common side effects, and mode and frequency of administration. In those countries in which patients contribute to the cost of their treatment directly, a fifth attribute was added: out-of-pocket cost. A mixed logit panel model was used to estimate patients' preferences. Results. In total, 1124 patients completed the experiment, with a sample of between 98 and 257 patients per country. In all countries, patients preferred treatment with higher effectiveness, and 6-monthly subcutaneous injection was always preferred over weekly oral tablets. In five countries, patients also preferred a monthly oral tablet and yearly i.v. injections over weekly oral tablets. In the three countries where the out-of-pocket cost was included as an attribute, lower costs significantly contributed to the treatment preference. Between countries, there were statistically significant differences for 13 out of 42 attribute/level interactions. Conclusion. We found statistically significant differences in patients' preferences for anti-osteoporosis medications between countries, especially for the mode of administration. Our findings emphasized that international treatment recommendations should allow for local adaptation, and that understanding individual preferences is important if we want to improve the quality of clinical care for patients with osteoporosis. [ABSTRACT FROM AUTHOR]

Background: This study aimed to assess the short- and long-term safety and efficacy of the sutured haemorrhoidopexy (SH) in patients with haemorrhoidal disease (HD). Methods: A retrospective study was performed, assessing the following treatment characteristics: number of sutures needed; operation time; perioperative complications; postoperative pain; hospital stay. The short- and long-term postoperative complications, HD recurrence and data on current HD symptoms were assessed according to the Core Outcome Set for HD. Results: Between January 2009 and December 2021, 149 patients with HD underwent a SH. One-hundred and forty-five patients were included, with a mean age of 61 years (±12.8), of which 70 were women (48.3%). Patients were predominantly diagnosed with grade III (37.2%) HD and the median follow-up was nine years (5–11). Perioperative complications occurred in four cases (2.8%). In two patients (1.4%), short-term postoperative complications were reported, and in seven patients (6.2%), long-term complications were reported. The cumulative efficacy in terms of freedom of recurrence was 88.3% (95% CI, 83.1–93.5) at six months, 80.0% (95% CI, 73.5–86.5) at one year, and 67.7% (95% CI, 59.7–75.7) at five years. Conclusions: Sutured haemorrhoidopexy is a safe treatment for patients with HD and can be proposed as a minimally invasive surgical treatment if basic and outpatient procedures fail. [ABSTRACT FROM AUTHOR]

Currently, ISBCS is no routine procedure in the Netherlands. Potential implementation barriers include fear of bilateral endophthalmitis, medicolegal issues, and a lack of availability of separate products for both eyes. Purpose: To evaluate current practice patterns of immediate sequential bilateral cataract surgery (ISBCS) in the Netherlands and assess ophthalmologists' attitudes toward performing ISBCS in future cataract care. Setting: Dutch ophthalmic society members. Design: Cross-sectional study (national survey). Methods: An electronic survey on ISBCS was sent as part of an annual survey on cataract practice patterns to members of the Dutch ophthalmic society. Questions regarding current ISBCS practice patterns, willingness to perform ISBCS routinely in future care, reasons for performing ISBCS, and reasons for not performing ISBCS were included. Data were analyzed using descriptive statistics. Results: 237 (45.6%) of 520 survey recipients responded to the overall survey. Data on the ISBCS questions were available from 227 respondents. 62 ophthalmologists (27.3%) currently performed ISBCS, predominantly in low patient volumes (90.3% on 1 to 5 patients per month). However, 108 (47.6%) of 227 ophthalmologists considered performing ISBCS routinely in future practice. Procedures for which ISBCS was mainly considered included age-related cataract surgery using topical and general anesthesia. Availability of separate products and instruments for both eyes and patient advantages were considered of high importance when performing ISBCS. Main reasons for not performing ISBCS included the risk for endophthalmitis and potential medicolegal aspects. Conclusions: Although ISBCS is currently not a routine procedure in the Netherlands, it is considered by almost 50% of surgeons. To improve implementation on a national level, potential barriers identified in this survey (fear of bilateral endophthalmitis, potential medicolegal issues, and a lack of availability of separate products for both eyes) should be addressed. [ABSTRACT FROM AUTHOR]

Aim: Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient's quality of life. Here, we describe the development and validation of the Dutch patient reported outcome measure‐haemorrhoidal impact and satisfaction score (PROM‐HISS). Methods: The development of the PROM‐HISS followed recommended guidelines. Face and content validity, structural properties, reliability and construct validity were evaluated in a HD population. Reliability was tested by assessing the test‐retest reliability, defined by the intraclass correlation coefficient (ICC), and internal consistency measured with Cronbach's alpha. Construct validity was evaluated using confirmatory factor analysis (CFA) and hypotheses testing. Results: The PROM‐HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms on daily activities, and (3) satisfaction with treatment. The PROM‐HISS showed good face and content validity. The PROM‐HISS was completed by 102 patients (65% male), with a mean age of 58 years (23–81 years). The ICCs of the different items in the domain HD symptoms ranged between 0.56 and 0.79 and were interpreted as good. The Cronbach's alpha value was 0.80 and considered satisfactory. The CFA provided further evidence for construct validity with a good model fit. A high score on the symptoms of HD correlated with a high impact of HD on daily activities (Pearson's r = 0.632, p < 0.01) and a low degree of satisfaction (Pearson's r = 0.378, p < 0.01). Conclusion: The PROM‐HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment. [ABSTRACT FROM AUTHOR]

Background: Subclinical depressive symptoms are highly prevalent among adolescents and are associated with negative consequences, which may pose an economic burden for society. We conducted a prevalence‐based cost‐of‐illness study using a societal perspective to investigate the cost‐of‐illness of subclinical depressive symptoms among adolescents. Methods: Using a bottom‐up approach, cost questionnaires were assessed to measure costs from 237 Dutch families with an adolescent aged 11–18 with subclinical depressive symptoms (of which 34 met the criteria of a depressive disorder). The study is registered in the Dutch Trial Register (Trial NL5584/NTR6176; www.trialregister.nl/trial/5584). Results: Our calculations show that adolescents with subclinical depressive symptoms cost the Dutch society more than €42 million annually, expressed in costs related to depressive symptoms. Secondary analyses were performed to test the reliability and stability of the costs. When costs related to psychological problems were considered, the annual costs amounted to €67 million. The total societal costs related to physical problems amounted to approximately €126 million. All costs combined (depressive, psychological, behavioural and physical problems and other reasons) amounted to a €243 million. Total costs were highest for physical‐related problems of the adolescent (52% of the total costs), followed by psychological (28%), depressive (17%) and behavioural problems (1%). Using an international prevalence rate, societal costs related to depressive symptoms resulted in €54 million a year. Conclusions: Cost‐effective prevention programmes seem warranted given the high societal costs and risk of future costs as subclinical depressive symptoms could be a precursor of clinical depression later in life. [ABSTRACT FROM AUTHOR]

The ESCRS PREMED study showed that perioperative subconjunctival triamcinolone acetonide was effective in prevention of pseudophakic cystoid macular edema in diabetic patients. This study confirmed that it is also cost-effective. Purpose: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. Setting: 7 ophthalmology clinics in the Netherlands and Belgium. Design: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. Methods: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). Results: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. Conclusions: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective. [ABSTRACT FROM AUTHOR]

Background: Quality of life (QoL) is an important patient-reported outcome that has been studied extensively as an endpoint. There is a growing interest in factors that may influence QoL, such as personality. This descriptive systematic review examined the relationship between personality and QoL in women with non-metastatic breast cancer.  METHODS: On November 24th, 2020, with a update on March 7th, 2022, PubMed, PsycINFO, CINAHL, Web of Science and Embase were systematically searched for studies that assessed the direct relationship between personality traits and QoL among adult women diagnosed with non-metastatic breast cancer. The National Institutes of Health Study Quality Assessment Tool was used to assess the quality and risk of bias of the included studies. Three reviewers independently extracted data regarding objectives, population, setting, design, method, outcome measurements and key results. The results are descriptively reported.Results: Twelve studies (6 cohort studies and 6 cross-sectional studies) were included. Three studies were rated as poor, one study was rated as good, and the remaining studies were rated as moderate. There was a small to moderate effect of personality on QoL as correlation coefficients ranged from 0.10 to 0.77, and the explained variance ranged from 4 to 43%. The (strength of the) relationship depended on the personality trait and QoL domain that was measured and was most apparent for the personality traits 'optimism' and 'trait anxiety' on psychosocial QoL domains. The results for the personality traits (unmitigated) agency, agreeableness, conscientiousness, novelty seeking, and self-efficacy indicated a smaller but statistically significant correlation between these personality traits and QoL.Conclusions: The results confirm that personality affects QoL in women with non-metastatic breast cancer and thus provides evidence that personality traits are indeed important influential factors of QoL. It is therefore strongly recommended for all future QoL research to measure personality traits and use these variables as predictive factors, as they are needed to accurately interpret QoL. Information regarding personality traits provide physicians and patients with an interpretation of low or deterioration of QoL, which could guide physicians to improve their patients' health outcomes and subsequently QoL using psycho-oncological support or treatment. [ABSTRACT FROM AUTHOR]

Background: Standardized risk assessment tools can be used to identify patients at higher risk for postoperative complications and death. In this study, we validate the PreOperative Score to predict Post-Operative Mortality (POSPOM) for in-hospital mortality in a large cohort of non-cardiac surgery patients. In addition, the performance of POSPOM to predict postoperative complications was studied. Methods: Data from the control cohort of the TRACE (routine posTsuRgical Anesthesia visit to improve patient outComE) study was analysed. POSPOM scores for each patient were calculated post-hoc. Observed in-hospital mortality was compared with predicted mortality according to POSPOM. Discrimination was assessed by receiver operating characteristic curves with C-statistics for in-hospital mortality and postoperative complications. To describe the performance of POSPOM sensitivity, specificity, negative predictive values, and positive predictive values were calculated. For in-hospital mortality, calibration was assessed by a calibration plot. Results: In 2490 patients, the observed in-hospital mortality was 0.5%, compared to 1.3% as predicted by POSPOM. 27.1% of patients had at least one postoperative complication of which 22.4% had a major complication. For in-hospital mortality, POSPOM showed strong discrimination with a C-statistic of 0.86 (95% CI, 0.78–0.93). For the prediction of complications, the discrimination was poor to fair depending on the severity of the complication. The calibration plot showed poor calibration of POSPOM with an overestimation of in-hospital mortality. Conclusion: Despite the strong discriminatory performance, POSPOM showed poor calibration with an overestimation of in-hospital mortality. Performance of POSPOM for the prediction of any postoperative complication was poor but improved according to severity. [ABSTRACT FROM AUTHOR]

Background. The introduction of innovative non-invasive screening tests (e.g. tests based on stool and blood samples or both) may be a solution to increase colorectal cancer (CRC) screening uptake. However, preferences for these non-invasive screening tests have not been investigated in great detail yet. The purpose of this article therefore is to elicit individuals' preferences for different non-invasive screening tests in a Dutch screening campaign context. Material and methods. We investigate preferences by means of a labeled discrete choice experiment. Data of 815 individuals, aged 55-75 years, are used in the analysis. Results. Multinomial logit model analysis showed that the combi-test is generally preferred over the blood-test and the (currently available) stool-test. Furthermore, besides the large effect of screening test type, there are significant differences in preference depending on participants' socio-demographic background. Finally, the analysis showed a significant positive effect on screening test choice for the attributes sensitivity, risk reduction, and level of evidence and a non-significant effect for the attribute unnecessary follow-up test. Conclusion. Introducing new non-invasive screening tests that are based on a combination of stool and blood samples (or blood sample only) has the potential to increase CRC screening participation compared to the current standard stool-based test. [ABSTRACT FROM AUTHOR]

Background: Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives). Methods: An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs. Discussion: This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Customized care can be beneficial for patients when preferences for health care programs are heterogeneous. Yet, there is little guidance on how individual-specific preferences and cost data can be combined to inform health care decisions about customized care. Therefore, we propose a discrete choice experiment–based approach that illustrates how to analyze the cost-effectiveness of customized (and noncustomized) care programs to provide information for hospital managers. Methods: We exploit the fact that choice models make it possible to determine whether preference heterogeneity exists and to obtain individual-specific parameter estimates. We present an approach of how to combine these individual-specific parameter estimates from a random parameter model (mixed logit model) with cost data to analyze the cost-effectiveness of customized care and demonstrate our method in the case of follow-up after breast cancer treatment. Results: We found that there is significant preference heterogeneity for all except two attributes of breast cancer treatment follow-up and that the fully customized care program leads to higher utility and lower costs than the current standardized program. Compared with the single alternative program, the fully customized care program has increased benefits and higher costs. Thus, it is necessary for health care decision makers to judge whether the use of resources for customized care is cost-effective. Conclusions: Decision makers should consider using the results obtained from our methodological approach when they consider implementing customized health care programs, because it may help to find ways to save costs and increase patient satisfaction. [Copyright &y& Elsevier]

BACKGROUND This study aimed to calculate costs and health-related quality of life of women with endometriosis-associated symptoms treated in referral centres. METHODS A prospective, multi-centre, questionnaire-based survey measured costs and quality of life in ambulatory care and in 12 tertiary care centres in 10 countries. The study enrolled women with a diagnosis of endometriosis and with at least one centre-specific contact related to endometriosis-associated symptoms in 2008. The main outcome measures were health care costs, costs of productivity loss, total costs and quality-adjusted life years. Predictors of costs were identified using regression analysis. RESULTS Data analysis of 909 women demonstrated that the average annual total cost per woman was €9579 (95% confidence interval €8559–€10 599). Costs of productivity loss of €6298 per woman were double the health care costs of €3113 per woman. Health care costs were mainly due to surgery (29%), monitoring tests (19%) and hospitalization (18%) and physician visits (16%). Endometriosis-associated symptoms generated 0.809 quality-adjusted life years per woman. Decreased quality of life was the most important predictor of direct health care and total costs. Costs were greater with increasing severity of endometriosis, presence of pelvic pain, presence of infertility and a higher number of years since diagnosis. CONCLUSIONS Our study invited women to report resource use based on endometriosis-associated symptoms only, rather than drawing on a control population of women without endometriosis. Our study showed that the economic burden associated with endometriosis treated in referral centres is high and is similar to other chronic diseases (diabetes, Crohn's disease, rheumatoid arthritis). It arises predominantly from productivity loss, and is predicted by decreased quality of life. [ABSTRACT FROM PUBLISHER]

Background: Preeclampsia and HELLP syndrome may have serious consequences for both mother and fetus. Women who have suffered from preeclampsia or the HELLP syndrome, have an increased risk of developing preeclampsia in a subsequent pregnancy. However, most women will develop no or only minor complications. In this study, we intend to determine cost-effectiveness of recurrence risk guided care versus care as usual in pregnant women with a history of early-onset preeclampsia. Methods/design: We developed a prediction model to estimate the individual risk of recurrence of early-onset preeclampsia and the HELLP syndrome. In a before-after study, pregnant women with preeclampsia or HELLP syndrome in their previous pregnancy receiving care as usual (before introduction of the prediction model) will be compared with women receiving recurrence risk guided care (after introduction of the prediction model). Eligible and pregnant women will be recruited at six university hospitals and seven large non-university tertiary referral hospitals in the Netherlands. The primary outcome measure is the recurrence of early-onset preeclampsia or HELLP syndrome in women allocated to the regular monitoring group. For the economic evaluation, a modelling approach will be used. Costs and effects of recurrence risk guided care with those of care as usual will be compared by means of a decision model. Two incremental cost-effectiveness ratios will be calculated: 1) cost per Quality Adjusted Life Year (mother unit of analysis) and 2) cost per live born child (child unit of analysis). Discussion: This is, to our knowledge, the first study that evaluates prospectively the efficacy of a multivariable prediction rule for recurrent hypertensive disease in pregnancy. Results of this study could either be integrated into the current guideline on Hypertensive Disorders in Pregnancy, or be used to develop a new guideline. [ABSTRACT FROM AUTHOR]

Background: Current frequent follow-up after treatment for breast cancer does not meet its intended aims, but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations. The study described in this paper compared patient satisfaction with a reduced follow-up strategy, i.e. nurse-led telephone follow-up, to satisfaction with traditional hospital follow-up. Methods: Patient satisfaction was assessed among patients (n = 299) who were participants of a randomized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer. Data on patient satisfaction were collected at baseline, three, six and 12 months after treatment, using the Dutch version of Ware's Patient Satisfaction Questionnaire III (PSQ III). In addition to general satisfaction, the PSQ III reports on satisfaction scores for technical competence, interpersonal aspects, and access of care. Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received. Results: Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction (p = 0.379), satisfaction with technical competence (p = 0.249), and satisfaction with interpersonal aspects (p = 0.662). Regarding access of care, patient satisfaction scores were significantly higher for patients receiving telephone followup (p = 0.015). However, a mean difference at 12 months of 3.1 points was judged to be not clinically relevant. Conclusions: No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment. With high satisfaction scores and the potential to substantially reduce clinic visits, nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up. Trial registration number: ISRCTN 74071417. [ABSTRACT FROM AUTHOR]

Objectives: Our main objective was to compare willingness to accept (WTA) and willingness to pay (WTP) in a discrete choice experiment on hearing aid provision. Additionally, income effect and endowment effect were explored as possible explanations for the disparity between WTA and WTP, and the impact of using a WTA and/or WTP format to elicit monetary valuations on the net benefit of the new organization of hearing aid provision was examined. Methods: Choice sets were based on five attributes: performer of the initial assessment; accuracy of the initial assessment; duration of the pathway; follow-up at the ear, nose, and throat specialist; and costs. Persons with hearing complaints randomly received a WTP (costs defined as extra payment) or WTA (costs defined as discount) version of the experiment. In the versions, except for the cost attribute, all choice sets were equal. Results: The cost coefficient was statistically significantly higher in the WTP format. Marginal WTA was statistically significantly higher than marginal WTP for the attributes accuracy and follow-up. Disparity was higher in the high educational (as proxy for income) group. We did not find proof of an experience endowment effect. Implementing the new intervention would only be recommended when using WTP. Conclusions: WTA exceeds WTP, also in a discrete choice experiment. As this affects monetary valuations, more research on when to use a payment or a discount in the cost attribute is needed before discrete choice results can be used in cost-benefit analyses. [ABSTRACT FROM AUTHOR]

Background: After curative treatment for breast cancer women frequently attend scheduled follow-up examinations. Usually the follow-up is most frequent in the first 2-3 years (2-4 times a year); thereafter the frequency is reduced to once a year in most countries. Its main aim is to detect local disease recurrence, or a second primary breast cancer, but also to provide information and psychosocial support. However, the cost-effectiveness of these frequent visits is under much debate, leading to a search for less intensive and more cost-effective follow-up strategies. In this paper the design of the MaCare trial is described. This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients. We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme. Methods/design: The MaCare trial is a multi centre randomised clinical trial in which 320 breast cancer patients are randomised into four follow-up strategies, focussed on the first 18 months after treatment: 1) standard follow-up; 2) nurse-led telephone follow-up; 3) arm 1 with the educational group programme; 4) arm 2 with the educational group programme. Data is collected at baseline and 3, 6, 12 and 18 months after treatment. The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30. Secondary outcomes are perceived feelings of control, anxiety, patients' satisfaction with follow-up and costs. A cost-effectiveness analysis will be performed from a societal perspective. Discussion: Reduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice. Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up. The MaCare trial combines a reduced follow-up strategy with additional psychosocial support. Less frequent follow-up can reduce the burden on medical specialists and costs. The educational group programme can improve QoL of patients, but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit. Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009. [ABSTRACT FROM AUTHOR]

Objective: To broadly synthesize literature regarding decision aids (DAs) supporting decision making about diet, physical activity, sleeping and substance use a scoping review was performed.Methods: Multiple sources were used: (1) Scientific literature searches, (2) excluded references from a Cochrane review regarding DAs for treatments and screenings, and (3) results from additional searches. Interventions had to (1) support informed decision making and (2) provide information and help to choose between at least two options. Two researchers screened titles and abstracts. Relevant information was extracted descriptively.Results: Thirty-five scientific articles and four DAs (grey literature) were included. Results were heterogeneous. Twenty-nine (94%) studies described substance use DAs. All DAs offered information and value and/or preference clarification. Many other elements were included (e.g., goal-setting). DA's effects were mixed. Few studies used standardized measures, e.g., decisional conflict (n = 4, 13%). Some positive behavioral effects were reported: e.g., smoking abstinence (n = 1).Conclusions: This research shows only some positive behavioral effects of DAs. However, studies reported heterogeneous results/outcomes, impeding knowledge synthesis. Areas of improvement were identified, e.g., establishing which intervention elements are effective regarding health behavior decision making.Practice Implications: DAs can potentially be beneficial in supporting people to change health behaviors - especially regarding smoking. [ABSTRACT FROM AUTHOR]

Discussing the individual probability of a successful vaginal birth after caesarean (VBAC) can support decision making. The aim of this study is to externally validate a prediction model for the probability of a VBAC in a Dutch population. In this prospective cohort study in 12 Dutch hospitals, 586 women intending VBAC were included. Inclusion criteria were singleton pregnancies with a cephalic foetal presentation, delivery after 37 weeks and one previous caesarean section (CS) and preference for intending VBAC. The studied prediction model included six predictors: pre-pregnancy body mass index, previous vaginal delivery, previous CS because of non-progressive labour, Caucasian ethnicity, induction of current labour, and estimated foetal weight ≥90th percentile. The discriminative and predictive performance of the model was assessed using receiver operating characteristic curve analysis and calibration plots. The area under the curve was 0.73 (CI 0.69–0.78). The average predicted probability of a VBAC according to the prediction model was 70.3% (range 33–92%). The actual VBAC rate was 71.7%. The calibration plot shows some overestimation for low probabilities of VBAC and an underestimation of high probabilities. The prediction model showed good performance and was externally validated in a Dutch population. Hence it can be implemented as part of counselling for mode of delivery in women choosing between intended VBAC or planned CS after previous CS. [ABSTRACT FROM AUTHOR]