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BackgroundDecision 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. ObjectiveWe 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. MethodsThe 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. ResultsData regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021. ConclusionsBy 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. Trial RegistrationNetherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID)DERR1-10.2196/21772

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]

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]

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]

Aims: The primary aim was to explore the age dependency of health state values derived via trade-offs between health-related quality of life (HRQoL) and life years in a discrete choice experiment (DCE). The secondary aim was to explore if people weigh life years and HRQoL differently for children, adolescents, adults, and older adults. Methods: Participants from the general population of the Netherlands and China first completed a series of choice tasks offering choices between two EQ-5D-Y states with a given lifespan. The choice model captured the value of a year in full health, disutility determined by EQ-5D-Y, and a discount rate. Next, they received a slightly different choice task, offering choices between two lives that differed in HRQoL and life expectancy but produced the same number of quality-adjusted life years (QALYs). Participants were randomly assigned to fill out the survey for three or four age frames: a hypothetical person of 10, 15, 40, and 70 years (the last one only applicable to China) to allow the age dependency of the responses to be explored. Results: A total of 1,234 Dutch and 1,818 Chinese people administered the survey. Controlling for time preferences, we found that the agreement of health state values for different age frames was generally stronger in the Netherlands than in China. We found no clear pattern of differences in the QALY composition in both samples. The probability distribution over response options variedmost when levels for lifespan or severity were at the extremes of the spectrum. Conclusion/discussion: The magnitude and direction of age effects on values seemed dimension- and country specific. In the Netherlands, we found a few differences in dimension-specific weights elicited for 10- and 15-year-olds compared to 40-year-olds, but the overall age dependency of values was limited. A stronger age dependency of values was observed in China, where values for 70-year-olds differed strongly fromthe values for other ages. The appropriateness of using existing values beyond the age range for which they weremeasured needs to be evaluated in the local context. [ABSTRACT FROM AUTHOR]

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]

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]

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.

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]

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]

Objective: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients. Background: Postoperative complications are the leading cause of perioperative morbidity and mortality. Although modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration. Methods: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in 9 academic and nonacademic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day 1 and 3 to routine use of MEWS in 5473 patients undergoing elective noncardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay, and intensive care unit admission. Results: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0.56% (n = 14) in the control and 0.44% (n = 12) in the intervention group (odds ratio 0.74, 95% Confidence interval 0.34–1.62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1.7% (n = 41) vs 1.0% (n = 27), P = 0.014). Median length of hospital stay did not differ significantly between groups. During the postanesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day 1 and 3, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up. Conclusions: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence to the recommendations provided and in a high-risk population might have a stronger impact on postoperative mortality remains to be determined. Trial Registration: Netherlands Trial Registration, NTR5506/ NL5249, https://www.trialregister.nl/trial/5249. [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]

Comorbid anxiety disorders are common in children with autism spectrum disorders (ASD). However, studies comparing children with ASD to clinically anxious children are rare. This study investigated anxiety problems and health-related quality of life in children with high-functioning ASD and comorbid anxiety disorders (referred to as the ASD group), compared with children with anxiety disorders (referred to as the AD group). In total, 237 families participated; 115 children were in the ASD group (90 boys and 25 girls, "M" age = 11.37 years), and 122 children were in the AD group (62 boys and 60 girls, "M" age = 12.79 years). Anxiety disorders, anxiety symptoms, ASD-like symptoms, and health-related quality of life were assessed with the ADIS-C/P, SCARED-71, CSBQ, and EuroQol-5D, respectively. The number and types of anxiety disorders, as well as their severity, were similar in the ASD and AD groups; however, specific phobias were more common in the ASD group than in the AD group. As compared to the AD group, parents from the ASD group reported their children to have higher scores for total anxiety, social anxiety disorder, and panic disorder. More ASD-like behaviors and higher anxiety severity predicted a lower quality of life, irrespective of group. The results of this study support a highly similar phenotype of anxiety disorders in children with ASD; however, additional research is needed to examine the etiology and treatment effectiveness of anxiety disorders in children with ASD. (Contains 4 tables.)

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 2,748 euros 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.