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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 euro8851 (US$11 406) for DMEK and euro8320 (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 euro2500 to euro80.000 (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.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in diabetic patients.SETTING: Seven 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 uncomplicated 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: Mean total healthcare costs and QALYs were: Triamcinolone € 1827 (US$ 2295) / 0.166; Bevacizumab € 2050 (US$ 2575) / 0.144; Combination € 2027 (US$ 2546) / 0.166; Control € 2041 (US$ 2564) / 0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was € 321,984 (US$ 404,503) per QALY for the combination group compared to the triamcinolone group. Assuming the willingness-to-pay is € 20,000 (US$ 25,126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient that 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 triamcinolone is also cost-effective.

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.

INTRODUCTION: The impact of amyloid positron emission tomography (PET) imaging on patient health outcomes for individuals with dementia is unknown. In the present study, we explored the association between diagnostic outcome and clinician's level of certainty with quality of life (QoL) after [18F]flutemetamol PET results were disclosed in young onset dementia patients in a memory clinic cohort.METHODS: In 154 patients suspected of dementia, QoL was measured before and after [18F]flutemetamol PET results were disclosed. Multiple regression analyses were conducted with (changed) general and disease-specific QoL measures as dependent factors [QoL-Alzheimer disease (AD) and EQ-5D Dutch tariff] and etiological diagnosis and clinician's certainty as independent factors.RESULTS: (Change in) diagnosis of AD was associated to QOL in 2 of the 4 analyses (utility-based QoL β=0.15, P=0.010; disease-specific QoL β=2.0, P=0.037). Diagnostic certainty was associated to QOL in 1 of the 4 analyses (generic QoL β=0.002, P=0.028).DISCUSSION: The diverse results in this explorative analysis do not reflect a univocal association between diagnosis, certainty, and QoL. Nevertheless, this result could be interpreted as a possible potential for advanced diagnostic technologies for AD, which requires confirmation in future research.

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. (c) 2021 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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.

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; HBB). Healthcare costs in year 1 were euro7302 (95% confidence interval euro6476-euro8258) for participants with LBB and euro10,738 (euro9141-euro12,708) for participants with HBB. In year 2, costs were euro8830 (euro7372-euro10,562) and euro14,933 (euro12,041-euro18,520), respectively. Main cost drivers were hospitalizations, contact with other healthcare professionals and rehabilitation. Costs outside the healthcare sector in year 1 were euro682 (euro520-euro900) for participants with LBB and euro1520 (euro1210-euro1947) for participants with HBB. In year 2, costs were euro829 (euro662-euro1046) and euro1457 (euro1126-euro1821) 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.

Objectives 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. Methods 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. Results 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. Conclusions 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.

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 447 (US $562) and 0.174 in the bromfenac group, euro421 (US $529) and 0.179 in the dexamethasone group, and euro442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was euro6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is euro 20000 (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.J Cataract Refract Surg 2021; 47:331-339 Copyright (c) 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS

Purpose In current cancer care, there is a growing debate about the value of using patient-reported outcome measures (PROMs) in daily clinical follow-up. A systematic review of the literature was conducted to assess the evidence of the effectiveness of the routine use of PROMs in daily cancer care in terms of patient outcomes, patient experiences and process indicators and to identify the effect of giving feedback about PROM findings to patients and/or health care professionals (HCPs). Methods A systematic search was performed. Studies were eligible for inclusion when they (1) used a PROM as an intervention, with or without feedback to patients and/or HCPs, compared with not using a PROM, and (2) used a PROM as an intervention with feedback to patients and/or HCPs, compared with using a PROM without giving feedback to patients and/or HCPs. Results After screening of 8341 references, 22 original studies met the inclusion criteria. Most studies found a positive effect on survival, symptoms, HRQoL and patient satisfaction. In general, using feedback to patient and/or HCPs about the PROM results led to better symptom control, HRQoL, patient satisfaction and patient-doctor communication. The majority of included studies had insufficient power to detect significant differences in the outcomes assessed. Conclusion This review shows that predominantly positive findings were found in the use of a PROM in daily cancer care. Additionally, more positive effects were seen when feedback is provided to patient and/or health care professionals, and it is thus highly recommended that this is always done.

BACKGROUND: Age‐related cataract affects both eyes in most cases. Most people undergo cataract surgery in both eyes on separate days, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating on both eyes on the same day, but as two separate procedures, known as immediate sequential bilateral cataract surgery (ISBCS). Potential advantages of ISBCS include fewer hospital visits for the patient, faster visual recovery, and lower healthcare costs. Nevertheless, concerns exist about possible bilateral, postoperative, sight‐threatening adverse effects with ISBCS. Therefore, there is a clear need for evaluating evidence regarding the safety, effectiveness, and cost‐effectiveness of ISBCS versus DSBCS. OBJECTIVES: To assess the safety of ISBCS compared to DSBCS in people with bilateral age‐related cataracts and to summarise current evidence for the incremental resource use, utilities, costs, and cost‐effectiveness associated with the use of ISBCS compared to DSBCS in people with bilateral age‐related cataracts (primary objectives). The secondary objective was to assess visual and patient‐reported outcomes of ISBCS compared to DSBCS in people with bilateral age‐related cataracts. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 5); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; the WHO ICTRP; and DARE and NHS EED on the CRD Database on 11 May 2021. There were no language restrictions. We limited the searches to a date range of 2007 onwards. SELECTION CRITERIA: We included randomised controlled trials (RCTs) to assess complications, refractive outcomes, best‐corrected distance visual acuity (BCDVA) and patient‐reported outcome measures (PROMs) with ISBCS compared to DSBCS. We included non‐randomised (NRSs), prospective, and retrospective cohort studies comparing ISBCS and DSBCS for safety assessment, because of the rare incidence of important adverse events. To assess cost‐effectiveness of ISBCS compared to DSBCS, we included both full and partial economic evaluations, and both trial‐based and model‐based economic evaluations. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures and assessed risk of bias for NRSs using the ROBINS‐I tool. For cost‐evaluations, we used the CHEC‐list, the CHEERS‐checklist, and the NICE‐checklist to investigate risk of bias. We assessed the certainty of evidence with the GRADE tool. We reported results for economic evaluations narratively. MAIN RESULTS: We included 14 studies in the review; two RCTs, seven NRSs, and six economic evaluations (one study was both an NRS and economic evaluation). The studies reported on 276,260 participants (7384 for ISBCS and 268,876 for DSBCS) and were conducted in Canada, the Czech Republic, Finland, Iran, (South) Korea, Spain (Canary Islands), Sweden, the UK, and the USA. Overall, we considered the included RCTs to be at 'high to some concerns' risk of bias for complications, 'some concerns' risk of bias for refractive outcomes and visual acuity, and 'high' risk of bias for PROMs. The overall risk of bias for NRSs was graded 'serious' regarding complications and 'serious to critical' regarding refractive outcomes. With regard to endophthalmitis, we found that relative effects were estimated imprecisely and with low certainty, so that relative estimates were not reliable. Nonetheless, we found a very low risk of endophthalmitis in both ISBCS (1/14,076 participants) and DSBCS (55/556,246 participants) groups. Based on descriptive evidence and partially weak statistical evidence we found no evidence of an increased risk of endophthalmitis with ISBCS. Regarding refractive outcomes, we found moderate‐certainty (RCTs) and low‐certainty (NRSs) evidence there was no difference in the percentage of eyes that did not achieve refraction within 1.0 dioptre of target one to three months after surgery (RCTs: risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.26; NRSs: RR 1.02, 95% CI 0.60 to 1.75). Similarly, postoperative complications did not differ between groups (RCTs: RR 1.33, 95% CI 0.52 to 3.40; NRSs: 1.04, 95% CI 0.47 to 2.29), although the certainty of this evidence was very low for both RCTs and NRSs. Furthermore, we found low‐certainty (RCTs) to very low‐certainty (NRSs) evidence that total costs per participant were lower for ISBCS compared to DSBCS, although results of individual studies could not be pooled. Only one study reported on cost‐effectiveness. This study found that ISBCS is cost‐effective compared to DSBCS, but did not measure quality‐adjusted life years using preferred methods and calculated costs erroneously. Finally, regarding secondary outcomes, we found limited evidence on BCDVA (data of two RCTs could not be pooled, although both studies individually found no difference between groups (very low‐certainty evidence)). Regarding PROMs, we found moderate‐certainty evidence (RCTs only) that there was no difference between groups one to three months after surgery (standardised mean difference −0.08, 95% CI −0.19 to 0.03). AUTHORS' CONCLUSIONS: Current evidence supports there are probably no clinically important differences in outcomes between ISBCS and DSBCS, but with lower costs for ISBCS. However, the amount of evidence is limited, and the certainty of the evidence was graded moderate to very low. In addition, there is a need for well‐designed cost‐effectiveness studies.

Background Two antifibrotic drugs, nintedanib and pirfenidone, are available for treatment of idiopathic pulmonary fibrosis (IPF). Although efficacy and adverse events have been well studied, little is known about patient experiences with these drugs. We aimed to systematically and quantitatively evaluate patient expectations, experiences, and satisfaction with nintedanib and pirfenidone. Furthermore, we assessed which factors were associated with overall patient satisfaction with medication. Methods Outpatients with IPF prospectively completed the Patient Experiences and Satisfaction with Medication (PESaM) questionnaire before start, and after three and 6 months of antifibrotic treatment, as part of a randomized eHealth trial (NCT03420235). The PESaM questionnaire consists of an expectation module, a validated generic module evaluating patient experiences and satisfaction concerning the effectiveness, side-effects, and ease of use of a medication, and a disease-specific module about IPF. Satisfaction was scored on a scale from − 5 (very dissatisfied) to + 5 (very satisfied). Results In total, 90 patients were included, of whom 43% used nintedanib and 57% pirfenidone. After 6 months, the mean overall score for satisfaction with medication was 2.1 (SD 1.9). No differences were found in experiences and satisfaction with medication, and the number and severity of side-effects between nintedanib and pirfenidone. Perceived effectiveness of medication was rated as significantly more important than side-effects and ease of use (p = 0.001). Expectations of patients regarding effectiveness were higher than experiences after 6 months. Self-reported experience with effectiveness was the main factor associated with overall medication satisfaction. Conclusions Patient experiences and satisfaction with antifibrotic treatment were fairly positive, and similar for nintedanib and pirfenidone. Systematic evaluation of patient expectations, experiences, and satisfaction with medication could enhance shared-decision making and guide drug treatment decisions in the future. Trial registration NCT03420235.

BackgroundCataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness.Methods/designMulticenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire.DiscussionThis study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS.Trial registrationThis study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier:NCT03400124.

Background Little is known about the costs of the current treatment strategy in locally advanced rectal cancer, in which patients with a clinical complete response after chemoradiotherapy are treated in a watch-and-wait policy. Objective The aim of this study is to present the oncological outcome and hospital costs of patients with a complete response after chemoradiotherapy (watch-and-wait policy) and patients with an incomplete response after chemoradiotherapy (total mesorectal excision). Design This was a cohort study. Settings This study was conducted at an academic and a nonacademic hospital. Patients Patients with locally advanced rectal cancer received either a watch-and-wait policy or total mesorectal excision depending on their clinical response to chemoradiotherapy. Interventions Watch-and-wait policy and total mesorectal excision were the treatments applied. Main outcome measures The primary outcomes measured were overall, local recurrence-free, and distant metastasis-free survival and hospital costs over a 2-year follow-up period. Results A total of 292 patients with locally advanced rectal cancer were included. Mean age was 65.1 years, and 64.7% were men. One hundred five patients were included in the watch-and-wait subgroup, and 187 patients were in the total mesorectal excision subgroup. Both subgroups showed good oncological outcomes. Hospital costs consisted of 5 categories: costs of primary surgery, costs of adjuvant chemotherapy, costs of examinations, costs of additional surgery, and costs of treatment of regrowth/metastasis. The mean costs per patient were O6713 (watch-and-wait subgroup) and O17,108 (total mesorectal excision subgroup) over the first 2 years. Limitations This study was limited by the following: costs were only from a hospital perspective, follow-up was 2 years, the study was retrospective in part, and there was no comparative study. Conclusions Overall survival was good in both subgroups and comparable to literature. The mean costs per patient differ between the watch-and-wait subgroup (O6713) and the total mesorectal excision subgroup (O17,108). No comparison between the groups could be made. Based on the results of this study, the current strategy, where patients with a clinical complete response are treated in a watch-and-wait policy, and patients with an incomplete response are treated with total mesorectal excision, is likely to be (cost)saving. See Video Abstract at http://links.lww.com/DCR/B177. RESULTADOS ONCOLOGICOS Y COSTOS HOSPITALARIOS EN EL TRATAMIENTO DE PACIENTES CON CANCER DE RECTO: ACTITUD DE ESPERA-VIGILANCIA Y TRATAMIENTO QUIRURGICO ESTANDARD: Se sabe poco sobre el costo del tratamiento actual en casos de cancer de recto localmente avanzado, cuando se aplica una politica de vigilancia y espera en aquellos pacientes que presentan una respuesta clinica completa despues de radio-quimioterapia.El proposito final del presente estudio es dar a conocer el resultado oncologico y los costos hospitalarios de los pacientes que presentan una respuesta clinica completa despues de radio-quimioterapia (actitud de vigilancia-espera) y los pacientes con una respuesta incompleta despues luego de radio-quimioterapia (excision total del mesorrecto-ETM).Estudio de cohortes.Hospitales academicos y no academicos.Todos aquellos pacientes tratados por un cancer de recto localmente avanzado y que fueron seguidos con una politica de vigilancia y espera o la ETM, en funcion de la respuesta clinica a la radio-quimioterapia.Politicas de vigilancia-espera, excision total del mesorrecto.Sobrevida global libre de recurrencia local, metastasis a distancia, sobrevida libre de enfermedad y costos hospitalarios durante un periodo de seguimiento de dos anos.Se incluyeron 292 pacientes diagnosticados de cancer de recto localmente avanzado. La edad media fue de 65,1 anos, 64,7% eran de sexo masculino. Se incluyeron 105 pacientes en el subgrupo de vigilancia-espera, y 187 en el subgrupo de excision total del mesorrecto. Ambos subgrupos mostraron optimos resultados oncologicos. Los costos hospitalarios se dividieron en cinco categorias: costos de cirugia primaria; costos de quimioterapia adyuvante; costos de examenes; costos de cirugia adicional; y costos del tratamiento de rebrote / metastasis. Los costos medios por paciente fueron de O 6.713 (subgrupo de espera-vigilancia) y O 17.108 (subgrupo de excision total del mesorrecto) durante los primeros dos anos.Analisis de costos desde una perspectiva hospitalaria durante un seguimiento de dos anos, estudio parcialmente retrospectivo, no comparativo.La sobrevida general fue optima en ambos subgrupos y comparable con la literatura. El costo promedio por paciente difiere entre el subgrupo de vigilancia y espera (O 6.713) con el subgrupo de la ETM(O 17.108). No se pudieron comparar definitivamente ambos grupos. Basados en los resultados del presente estudio, es probable que la estrategia actual, en la que los pacientes con respuesta clinica completa sean tratados con una politica de vigilancia y espera, presenten muy probablemente un cierto ahorro en el costo con relacion a los pacientes con una respuesta incompleta tratados con excision total del mesorrecto. Consulte Video Resumen en http://links.lww.com/DCR/B177. (Traduccion-Dr. Xavier Delgadillo).

Objective: Effective healthcare innovations are often not adopted and implemented. An implementation strategy based on facilitators and barriers for use as perceived by healthcare professionals could increase adoption rates. This study therefore aimed to identify the most relevant facilitators and barriers for use of an innovative breast cancer aftercare decision aid (PtDA) in healthcare practice.Methods: Facilitators and barriers (related to the PtDA, adopter and healthcare organisation) were assessed among breast cancer aftercare health professionals (n = 81), using the MIDI questionnaire. For each category, a backward regression analysis was performed (dependent = intention to adopt). All significant factors were then added to a final regression analysis to identify to most relevant determinants of PtDA adoption.Results: Expecting higher compatibility with daily practice and clinical guidelines, more positive outcomes of use, higher perceived relevance for the patient and increased self-efficacy were significantly associated with a higher intention to adopt. Self-efficacy and perceived patient relevance remained significant in the final model.Conclusions: Low perceived self-efficacy and patient relevance are the most important barriers for health professions to adopt a breast cancer aftercare PtDA.Practice implications: To target self-efficacy and perceived patient relevance, the implementation strategy could apply health professional peer champions. (c) 2019 Published by Elsevier B.V.

BACKGROUND Smoking continues to be a driver of mortality. Various forms of evidence-based cessation assistance exist; however, their use is limited. The choice between them may also induce decisional conflict. Offering decision aids (DAs) may be beneficial; however, insights into their effective elements are lacking. OBJECTIVE This study tested the added value of an effective element (ie, an “explicit value clarification method” paired with computer-tailored advice indicating the most fitting cessation assistance) of a web-based smoking cessation DA. METHODS A web-based randomized controlled trial was conducted among smokers motivated to stop smoking within 6 months. The intervention group received a DA with the aforementioned elements, and the control group received the same DA without these elements. The primary outcome measure was 7-day point prevalence abstinence 6 months after baseline (time point 3 [t=3]). Secondary outcome measures were 7-day point prevalence of abstinence 1 month after baseline (time point 2 [t=2]), evidence-based cessation assistance use (t=2 and t=3), and decisional conflict (immediately after DA; time point 1). Logistic and linear regression analyses were performed to assess the outcomes. Analyses were conducted following 2 (decisional conflict) and 3 (smoking cessation) outcome scenarios: complete cases, worst-case scenario (assuming that dropouts still smoked), and multiple imputations. A priori sample size calculation indicated that 796 participants were needed. The participants were mainly recruited on the web (eg, social media). All the data were self-reported. RESULTS Overall, 2375 participants were randomized (intervention n=1164, 49.01%), of whom 599 (25.22%; intervention n=275, 45.91%) completed the DAs, and 276 (11.62%; intervention n=143, 51.81%), 97 (4.08%; intervention n=54, 55.67%), and 103 (4.34%; intervention n=56, 54.37%) completed time point 1, t=2, and t=3, respectively. More participants stopped smoking in the intervention group (23/63, 37%) than in the control group (14/52, 27%) after 6 months; however, this was only statistically significant in the worst-case scenario (crude P=.02; adjusted P=.04). Effects on the secondary outcomes were only observed for smoking abstinence after 1 month (15/55, 27%, compared with 7/46, 15%, in the crude and adjusted models, respectively; P=.02) and for cessation assistance uptake after 1 month (26/56, 46% compared with 18/47, 38% only in the crude model; P=.04) and 6 months (38/61, 62% compared with 26/50, 52%; crude P=.01; adjusted P=.02) but only in the worst-case scenario. Nonuse attrition was 34.19% higher in the intervention group than in the control group (P CONCLUSIONS Currently, we cannot confidently recommend the inclusion of explicit value clarification methods and computer-tailored advice. However, they might result in higher nonuse attrition rates, thereby limiting their potential. As a lack of statistical power may have influenced the outcomes, we recommend replicating this study with some adaptations based on the lessons learned. CLINICALTRIAL Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 INTERNATIONAL REGISTERED REPORT RR2-10.2196/21772

Despite recent studies confirming task shifting is both safe and effective, its implementation has proven difficult in practice. So too in the Netherlands, where legal barriers enforcing strict professional boundaries have historically limited task shifting. In recent years, Dutch policymakers have experimented with temporary expanded scopes of practice (ESP) for several professional groups, with the aim to facilitate task shifting in order to increase the overall effectiveness and efficiency of health care. The Clinical Technologist (CT), is an emerging new professional group that has received such a temporary ESP pending an evaluation. This paper reports the qualitative findings of the implementation process of providing CTs with an temporary ESP. Data collection consisted of 69 semi-structured interviews, 3 focus group interviews and 9 participant observations, conducted between September 2015 and October 2017. Analysis was conducted through an 'editing analysis style' whereby data were categorized using the conceptual framework of Grol & Wensing's implementation model. The study suggests that social features are of great importance when implementing task shifting. In situations with few social barriers, organizational and administrative barriers seem to be less dominant, thereby expediting the overall implementation process. Consequently, we recommend that policymakers should prioritize social features over organizational features when implementing task shifting. (C) 2019 Elsevier B.V. All rights reserved.

This study revealed patterns in osteoporosis patients' treatment preferences, which cannot be related to socio-demographic or clinical characteristics, implicating unknown underlying reasons. Therefore, to improve quality of care and treatment, patients should have an active role in treatment choice, irrespective of their characteristics. Introduction Patient centeredness is important to improve the quality of care. Accounting for patient preferences is a key element of patient centeredness, and understanding preferences are important for successful and adherent treatment. This study was designed to identify different preferences profiles and to investigate how patient characteristics influence treatment preferences of patients for anti-osteoporosis drugs. Methods Data from a discrete choice experiment among 188 osteoporotic patients were used. The hypothetical treatment options were characterized by three attributes: treatment efficacy, side effects, and mode/frequency of administration. A mixed logit model was used to measure heterogeneity across the sample. Subgroup analyses were conducted to identify potential effect of patient characteristics. Latent class modeling (LCM) was applied. Associations between patients' characteristics and the identified latent classes were explored with chi-square. Results All treatment options were important for patients' decision regarding osteoporotic treatment. Significant heterogeneity was observed for most attributes. Subgroup analyses revealed that patients with a previous fracture valued efficacy most, and patients with a fear of needles or aged > 65 years preferred oral tablets. Elderly patients disliked intravenous medication. Three latent classes were identified, in which 6-month subcutaneous injection was preferred in two classes (86%), while oral tablets were preferred in the third class (14%). No statistically significant associations between the profiles regarding socio-demographic or clinical characteristics could be found. Conclusions This study revealed patterns in patients' preferences for osteoporosis treatment, which cannot be related to specific socio-demographic or clinical characteristics. Therefore, patients should be involved in clinical decision-making to reveal their preferences.

Purpose To evaluate the cost-effectiveness of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) versus standard DSAEK. Methods A cost-effectiveness analysis using data from a multicentre randomized clinical trial was performed. The time horizon was 12 months postoperatively. Sixty-four eyes of 64 patients with Fuchs' endothelial dystrophy were included and randomized to UT-DSAEK (n = 33) or DSAEK (n = 31). 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 questionnaire. The main outcome was the incremental cost-effectiveness ratio (ICER; incremental societal costs per QALY). Results Societal costs were euro9431 (US$11 586) for UT-DSAEK and euro9110 (US$11 192) for DSAEK. Quality-adjusted life years (QALYs) were 0.74 in both groups. The ICER indicated inferiority of UT-DSAEK. The cost-effectiveness probability ranged from 37% to 42%, assuming the maximum acceptable ICER ranged from euro2500-euro80 000 (US$3071-US$98 280) per QALY. Additional analyses were performed omitting one UT-DSAEK patient who required a regraft [ICER euro9057 (US$11 127) per QALY, cost-effectiveness probability: 44-62%] and correcting QALYs for an imbalance in baseline utilities [ICER euro23 827 (US$29 271) per QALY, cost-effectiveness probability: 36-59%]. Furthermore, the ICER was euro2101 (US$2581) per patient with clinical improvement in best spectacle-corrected visual acuity (>= 0.2 logMAR) and euro3274 (US$4022) per patient with clinical improvement in National Eye Institute Visual Functioning Questionnaire-25 composite score (>= 10 points). Conclusion The base case analysis favoured DSAEK, since costs of UT-DSAEK were higher while QALYs were comparable. However, additional analyses revealed no preference for UT-DSAEK or DSAEK. Further cost-effectiveness studies are required to reduce uncertainty.

Background The scope of implementation research is often restricted to the analysis of organizations that participate voluntarily in implementation interventions. The recruitment of participants for a quality improvement collaborative increases awareness of the specific innovation. The objective of this multiphase observational study was to identify differences between organizations that participated in a large-scale implementation project aiming to improve perioperative care, functional recovery, and length of hospital stay after gynecologic surgery and organizations that did not participate. A secondary objective was to explore how perioperative practice changed among nonparticipants. Methods Of the seven gynecology departments of nonparticipating Dutch hospitals, five agreed to participate in a retrospective analysis. Baseline data of participating hospitals’ (N = 19) characteristics, time to functional recovery, and length of hospital stay were compared. Outcome measures for the subsequent pre-post awareness study in the five nonparticipating hospitals were: (1) overall adherence to predefined evidence-based perioperative elements; and (2) change in functional recovery and length of hospital stay. Multivariable regression models, adjusted for baseline characteristics, were used for analysis. Results In retrospect, nonparticipating and participating hospitals did not differ in baseline characteristics, functional recovery, and length of hospital stay. In three of the five nonparticipating hospitals, adherence to the selected evidence-based perioperative elements increased significantly after awareness of the trial (overall mean difference 9.7%, 95% CI 6.9 to 12.5%, p

IntroductionEvidence-based cessation assistance is known to increase cessation rates. Activating personal preferences as part of the decision for smoking cessation assistance tools could further improve tools’ effectiveness. Decision aids (DAs) help individuals to choose amongst the various options by taking these preferences into account and, therefore, could have a positive effect on cessation rates. To develop attractive and effective DAs, potential end users’ needs, and experts’ viewpoints should be considered during development processes. Therefore, the aim of this study was: (1) To explore smokers’ needs and viewpoints regarding a smoking cessation assistance DA, and (2) to obtain consensus among smoking cessation counsellors and scientific experts about the content and format of such a DA.Materials and methodsData was gathered via two approaches applied across three studies: (1) 20 semi-structured interviews with potential end users, (2) two three-round Delphi studies with 61 smoking cessation counsellors and 44 scientific experts. Data from the interviews and the first round of the Delphi studies were analysed qualitatively using the Framework method, while data from the second and third round of the Delphi studies were analysed quantitatively using medians and interquartile ranges.ResultsPotential end users reported to acquire information in different ways: Via own experiences, their social environment, and the media. Important characteristics to decide between tools also varied, however effectiveness and costs were commonly reported as the most important characteristics. The experts reached consensus on 38 (smoking cessation counsellors) and 40 (scientific experts) statements regarding important cessation assistance tools’ characteristics and their viewpoints on a smoking cessation assistance DA, e.g., that a tool should be appropriate for users’ level of addiction.Discussion and conclusionSome clear trends emerged among the potential end users (especially regarding important characteristics). Experts also reached consensus among a number of statements. However, there was some variation in the needs and wishes among the (different) stakeholders. The combination of these studies highlights that a ‘one size fits all’ approach is not desirable. In the development of DAs, this heterogeneity should be taken into account, e.g., by enabling users to customize a DA based on their personal preferences while safeguarding essential elements.HighlightsPotential end users’ needs for a smoking cessation DA vary greatlyHowever, tools’ effectiveness and costs were commonly named as importantCustomizable elements within a DA could be used to deal with this heterogeneityConceptualizations (e.g., of effectiveness) may vary between stakeholdersInformation should be provided to end users in an easily understandable manner

Background Chronic breathlessness is a frequent symptom in advanced Chronic Obstructive Pulmonary Disease (COPD) and has major impact on quality of life, daily activities and healthcare utilization. Morphine is used as palliative treatment of chronic breathlessness. The aim is to analyze cost-effectiveness of regular, low-dose morphine in patients with advanced COPD from a healthcare and societal perspective. Methods In a randomized controlled trial, participants with advanced COPD were assigned to 10 mg regular, oral sustained-release morphine or placebo twice daily for four weeks. Quality of life (COPD Assessment Test; CAT), quality-adjusted life years (QALY's; EQ-5D-5L), healthcare costs, productivity, and patient and family costs were collected. Incremental cost-effectivity ratio's (ICERs) using healthcare costs and CAT scores, and incremental cost-utility ratio's (ICURs) using societal costs and QALY's were calculated. Results Data of 106 of 124 participants were analyzed, of which 50 were in the morphine group (mean [SD] age 65.4 [8.0] years; 58 [55%] male). Both ICER and ICUR indicated dominance for morphine treatment. Sensitivity analyses substantiated these results. From a healthcare perspective, the probability that morphine is cost-effective at a willingness to pay €8000 for an minimal clinically important difference of 2 points increase in CAT score is 63%. From a societal perspective, the probability that morphine is cost-effective at a willingness to pay €20,000 per QALY is 78%. Conclusion Morphine for four weeks is cost-effective regarding the healthcare and the societal perspective. To estimate the long-term costs and effects of morphine treatment, a study of longer follow-up should be performed. Trial registration ClinicalTrials.gov (NCT02429050).

IntroductionResearchers, policy-makers and healthcare professionals often stress the importance of an early dementia diagnosis. Empirical evidence, however, is scarce leading to a lack of consensus on the necessity of diagnosing dementia early. We emphasise the need for a ‘timely’ diagnosis, that is, one that occurs at the right moment for a person with memory complaints and his/her significant other. As the optimal timing differs between individuals, the implementation of shared decision making (SDM), preferably by the general practitioner (GP), as the start of a diagnostic trajectory, could help to determine this timely moment. SDM, however, is rarely practised with respect to dementia diagnoses. Therefore, in the context of the Shared Decision-Making regarding Dementia Diagnosis project, a patient decision aid (PtDA) for ‘timely’ dementia diagnosis in general practice will be developed. This protocol will describe the planned before and after evaluation of its implementation.Methods and analysisIn a mixed-methods pilot study, we will investigate decision-making processes and experiences regarding a diagnostic trajectory before and after the introduction of a PtDA for people with memory complaints, their significant others and their GPs. The ‘before group’ will receive diagnostics as usual from their GPs. The ‘after group’ will use the PtDA. We expect the PtDA to increase the level of SDM and to contribute to a timely and personalised diagnostic trajectory. Data will be collected using semistructured interviews, questionnaires and information retrieved from people with memory complaints’ medical records.Ethics and disseminationThis study protocol was approved by the Medical Review Ethics Committee of the Maastricht University Medical Centre. The findings will be published in peer-reviewed international journals and presented at conferences. This study was funded by the public funded Dutch Research Institute for Care and Medical Sciences (ZonMw).Trial registration numberNCT04531956.

Background Examine whether the use of different ages has an impact on the valuation of EQ-5D-Y health states for a hypothetical child or adolescent. Methods A survey was administered during regular classes among a convenience sample of university students in the Netherlands. Respondents first valued 6 EQ-5D-Y health states (2 mild, 2 moderate, 2 severe) describing a hypothetical child/adolescent of a certain age on a visual analogue scale (VAS). After 1 h respondents valued the same six health states again but this time the age of the child was different. Age differed between 4, 10 and 16 year old. Results Number of respondents was 311. No significant differences in valuation of the six health states were found between the age of 10 and 16. One moderate health state was valued significantly better for a 4-year old compared to a 10 and a 16 year old. The same applied for one severe health state that was valued higher for a 4-year old compared to a 16-year old. Conclusion Our study shows that, except for one moderate and one severe health state, other EQ-5D-Y health states were not valued significantly different when description of age differed. It is possible that problems in specific health domains are considered more severe for older children/adolescents compared to younger children who might still be dependent on their caregivers. Future research should examine whether our findings are also present in a broader set of EQ-5D-Y health states, with a choice-based method like TTO or DCE, and a more heterogeneous sample.

Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov identifier: NCT04101773

Background In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor. Methods A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women’s satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992). Discussion We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a cost-effective intervention. Trial registration Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.

Contains fulltext : 229440.pdf (Publisher’s version ) (Open Access) BACKGROUND: Obstetric health care relies on an adequate antepartum risk selection. Most guidelines used for risk stratification, however, do not assess absolute risks. In 2017, a prediction tool was implemented in a Dutch region. This tool combines first trimester prediction models with obstetric care paths tailored to the individual risk profile, enabling risk-based care. OBJECTIVE: To assess impact and cost-effectiveness of risk-based care compared to care-as-usual in a general population. METHODS: A before-after study was conducted using 2 multicenter prospective cohorts. The first cohort (2013-2015) received care-as-usual; the second cohort (2017-2018) received risk-based care. Health outcomes were (1) a composite of adverse perinatal outcomes and (2) maternal quality-adjusted life-years. Costs were estimated using a health care perspective from conception to 6 weeks after the due date. Mean costs per woman, cost differences between the 2 groups, and incremental cost effectiveness ratios were calculated. Sensitivity analyses were performed to evaluate the robustness of the findings. RESULTS: In total 3425 women were included. In nulliparous women there was a significant reduction of perinatal adverse outcomes among the risk-based care group (adjusted odds ratio, 0.56; 95% confidence interval, 0.32-0.94), but not in multiparous women. Mean costs per pregnant woman were significantly lower for risk-based care (mean difference, -€2766; 95% confidence interval, -€3700 to -€1825). No differences in maternal quality of life, adjusted for baseline health, were observed. CONCLUSION: In the Netherlands, risk-based care in nulliparous women was associated with improved perinatal outcomes as compared to care-as-usual. Furthermore, risk-based care was cost-effective compared to care-as-usual and resulted in lower health care costs.

BACKGROUND Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness. OBJECTIVE We describe the development process of an online DA (called “VISOR”) that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice. METHODS The development of “VISOR” was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA’s (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA’s effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness. RESULTS Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. CONCLUSIONS By making use of an iterative process that integrated different stakeholders’ perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes. CLINICALTRIAL Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21772

Background: Mental health problems often arise in childhood and adolescence and can have detrimental effects on people's quality of life (QoL). Therefore, it is of great importance for clinicians, policymakers and researchers to adequately measure QoL in children. With this review, we aim to provide an overview of existing generic measures of QoL suitable for economic evaluations in children with mental health problems.Methods: First, we undertook a meta-review of QoL instruments in which we identified all relevant instruments. Next, we performed a systematic review of the psychometric properties of the identified instruments. Lastly, the results were summarized in a decision tree.Results: This review provides an overview of these 22 generic instruments available to measure QoL in children with psychosocial and or mental health problems and their psychometric properties. A systematic search into the psychometric quality of these instruments found 195 suitable papers, of which 30 assessed psychometric quality in child and adolescent mental health.Conclusions: We found that none of the instruments was perfect for use in economic evaluation of child and adolescent mental health care as all instruments had disadvantages, ranging from lack of psychometric research, no proxy version, not being suitable for young children, no age-specific value set for children under 18, to insufficient focus on relevant domains (e.g. social and emotional domains).

Additional file 1 Supplementary Table 1. Overview of topics included in PESaM questionnaires in different modules

The Risk of Malignancy Index (RMI) is commonly used to diagnose adnexal masses. The aim of the present study was to determine the cost-effectiveness of the RMI compared with subjective assessment (SA) by an expert and the following novel ultrasound models: Cost-effectiveness and budget impact analyses were performed from a societal perspective. A decision tree was constructed, and short-term costs and effects were examined in women with adnexal masses. Sensitivity, specificity and the costs of diagnostic strategies were incorporated. Incremental cost-effectiveness ratios were expressed as costs/additional percentage of correctly diagnosed patients. Probabilistic and deterministic sensitivity analyses were performed. Effectiveness was highest for SA (90.7% [95% confidence interval = 77.3-100]), with a cost saving of 5.0% (-€398 per patient [-€1403 to 549]) compared with the RMI. The costs of SR + SA were the lowest (€7180 [6072-8436]), resulting in a cost saving of 9.0% (-€709 per patient [-€1628 to 236]) compared with the RMI, with an effectiveness of 89.6% (75.8-100). SR + SA showed the highest probability of being the most cost-effective when willingness-to-pay was

Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation. This is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY). This is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial. This trial was approved by the hospitals’ joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757 .

Purpose Previously published literature regarding treatment of hemorrhoidal disease (HD) revealed a lack of uniform defined outcomes. These differences between outcomes among studies limit transparency and lead to incomparability of results. The aim of this study was to systematically list the types of outcomes used in HD studies. This list will be used to develop a core outcome set. Methods We searched Medline (Pubmed), Embase (OVID), and Cochrane for interventional studies for adult patients with HD. Two authors independently identified and reviewed eligible studies. This resulted in a list of outcomes reported by each clinical trial. All outcomes were categorized using the conceptual framework OMERACT filter 2.0. Results A total of 34 randomized controlled trials and prospective observational studies were included in this study. A total of 59 different types of outcomes were identified. On average, 5.8 different outcomes (range 2–8) were used per study. The outcomes were structured into three core areas and10 ten domains. The most commonly reported core area was pathophysiological manifestations including the domain symptoms, complications, and recurrence. The most frequently reported outcomes were pain (91%), blood loss (94%), prolapse (71%), and incontinence (56%). There was a high variation in definitions of the common outcomes. And often there was no definition at all. Conclusion This study shows a substantial heterogeneity in the types of outcomes in HD studies. We provided an overview of the types of outcomes reported in HD studies and identified a list of potentially relevant outcomes required for the development of a COS. Electronic supplementary material The online version of this article (10.1007/s00384-018-3046-2) contains supplementary material, which is available to authorized users.

Purpose The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. Methods This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF)

Rationale, aims, and objectivesSustainability of innovations is a relatively new concept in health care research and has become an issue of growing interest. The current study explored factors related to the sustainability of 2 multidisciplinary hospital-based programs 3 to 6years after achieving early implementation success.MethodAn exploratory qualitative study was conducted into 2 implementation cases, an Enhanced Recovery After Surgery program for colorectal surgery and a short-stay program for breast cancer surgery. Semistructured interviews were held with key persons involved in the care process in 14 hospitals from both cases minimally 3years after the implementation, between March 2012 and May 2013. The Consolidated Framework for Implementation Research was used to direct the development of the interview guide, during data collection and during analysis. A directed content analysis was performed.ResultsA total of 21 interviews with 26 individuals were held, 18 regarding the Enhanced Recovery After Surgery case and 8 regarding the short-stay program case. Respondents mentioned the following factors associated with sustainability of the programs: modification and adaptability of the program, cost-effectiveness, institutionalization into existing systems, short communication lines within the multidisciplinary team, an innovative culture, benefits for patients, cosmopolitanism, the existence of external policies and incentives, trust and belief in the program, and spread of the program to other settings. Two factors are not covered by the Consolidated Framework for Implementation Research, ie, modification of the program over the years and spread of the program to other contexts.ConclusionsThe factors associated with sustainability put forward in both cases were largely the same. Leadership and the implementation project were not mentioned as having influenced the long-term sustainability of the benefits achieved. Sustainability of the innovations is influenced by determinants stemming from all ecological levels of the health care system and demands continuous effort in the postimplementation phase.

Background Chronic pain is a major economic and social health problem. Up to 79% of chronic pain patients are unsatisfied with their pain management. Meeting patients’ expectations is likely to produce greater satisfaction with care. The challenge is to explore patients’ genuine expectations and needs. However, the term expectation encompasses several concepts and may concern different aspects of health-care provision. Objective This review aimed to systematically collect information on types and subject of patients’ expectations for chronic pain management. Search strategy We searched for quantitative and qualitative studies. Because of the multidimensional character of the term “expectations,” the search included subject headings and free text words related to the concept of expectations. Data extraction and synthesis A framework for understanding patients’ expectations was used to map types of expectations within structure, process or outcome of health care. Main results Twenty-three research papers met the inclusion criteria: 18 quantitative and five qualitative. This review found that assessment of patients’ expectations for treatment is mostly limited to outcome expectations (all 18 quantitative papers and four qualitative papers). Patients generally have high expectations regarding pain reduction after treatment, but expectations were higher when expressed as an ideal expectation (81-93% relief) than as a predicted expectation (44-64%). Discussion and conclusions For health-care providers, for pain management and for pain research purposes, the awareness that patients express different types of expectations is important. For shared decision making in clinical practice, it is important that predicted expectations of the patient are known to the treating physician and discussed. Structure and process expectations are under-represented in our findings. However, exploring and meeting patients’ expectations regarding structure, process and outcome aspects of pain management may increase patient satisfaction.