Health-related quality of life one year after refractory cardiac arrest treated with conventional or extracorporeal CPR; a secondary analysis of the INCEPTION-trial.

Background: Prospective, trial-based data comparing health-related quality of life (HRQoL) in patients surviving out-of-hospital cardiac arrest (OHCA) through extracorporeal cardiopulmonary resuscitation (ECPR) or conventional CPR (CCPR) are scarce. We aimed to determine HRQoL during 1-year after refractory OHCA in patients treated with ECPR and CCPR. Methods: We present a secondary analysis of the multicenter INCEPTION-trial, which studied the effectiveness of ECPR versus CCPR in patients with refractory OHCA. HRQoL was prospectively assessed using the EQ-5D-5L questionnaire. Poor HRQoL was pragmatically defined as an EQ-5D-5L health utility index (HUI) > 1 SD below the age-adjusted norm. We used mixed linear models to assess the difference in HRQoL over time and univariable analyses to assess factors potentially associated with poor HRQoL. Results: A total of 134 patients were enrolled, and hospital survival was 20% (27 patients). EQ-5D-5L data were available for 25 patients (5 ECPR and 20 CCPR). One year after OHCA, the estimated mean HUI was 0.73 (0.05) in all patients, 0.84 (0.12) in ECPR survivors, and 0.71 (0.05) in CCPR survivors (p-value 0.31). Eight (32%) survivors had a poor HRQoL. HRQoL was good in 17 (68%) patients, with 100% in ECPR survivors versus 60% in CCPR survivors (p-value 0.14). Conclusion: One year after refractory OHCA, 68% of the survivors had a good HRQoL. We found no statistically significant difference in HRQoL one year after OHCA in patients treated with ECPR compared to CCPR. However, numerical differences may be clinically relevant in favor of ECPR.

Unravelling Low-Value Care Decision-Making: Residents' Perspectives on the Influence of Contextual Factors.

BACKGROUND: Several initiatives have been developed to target low-value care (i.e. waste) in decision-making with varying success. As such, decision-making is a complex process and context's influence on decisions concerning low-value care is limitedly explored. Hence, a more detailed understanding of residents' decision-making is needed to reduce future low-value care. This study explores which contextual factors residents experience to influence their decision-making concerning low-value care. Methods: We employed nominal group technique to select four low-value care vignettes. Prompted by these vignettes, we conducted individual interviews with residents. We analyzed the qualitative data thematically using an inductive-deductive approach, guided by Bronfenbrenner's social-ecological framework. This framework provided guidance to 'context' in terms of sociopolitical, environmental, organizational, interpersonal, and individual levels. RESULTS: In 2022, we interviewed 19 residents from a Dutch university medical center. We identified 33 contextual factors influencing residents' decision-making, either encouraging or discouraging low-value care. The contextual factors resided in the following levels with corresponding categories: (1) environmental and sociopolitical: society, professional medical association, and governance; (2) organizational: facility characteristics, social infrastructure, and work infrastructure; (3) interpersonal: resident-patient, resident-supervising physician, and resident-others; and (4) individual: personal attributes and work structure. CONCLUSION: This paper describes 33 contextual factors influencing residents' decision-making concerning low-value care. Residents are particularly influenced by factors related to interactions with patients and supervisors. Furthermore, organizational factors and the broader environment set margins within which residents make decisions. While acknowledging that a multi(faceted)-intervention approach targeting all contextual factors to discourage low-value care delivery may be warranted, improving communication skills in the resident-patient dynamics to recognize and explain low-value care seems a particular point of interest over which residents can exercise an influence themselves.

Patient satisfaction and patient accessibility in a small fiber neuropathy diagnostic service in the Netherlands: A single-center, prospective, survey-based cohort study.

INTRODUCTION: Small fiber neuropathy (SFN) is a common cause of neuropathic pain in peripheral neuropathies. Good accessibility of diagnostics and treatment is necessary for an accurate diagnosis and treatment of SFN. Evidence is lacking on the quality performance of the diagnostic SFN service in the Netherlands. Our aim was to determine the patient satisfaction and -accessibility of the diagnostic SFN service, and to identify areas for improvement. METHODS: In a single-center, prospective, survey-based cohort study, 100 visiting patients were asked to fill in the SFN patient satisfaction questionnaire (SFN-PSQ), with 10 domains and 51 items. Cut-off point for improvement was defined as ≥ 25% dissatisfaction on an item. A chi-square test and linear regression analyses was used for significant differences and associations of patient satisfaction. RESULTS: From November 2020 to May 2021, 98 patients with SFN-related complaints filled in the online SFN-PSQ within 20 minutes. In 84% of the patients SFN was confirmed, average age was 55.1 (52.5-57.8) years and 67% was female. High satisfaction was seen in the domains 'Waiting List Period', Chest X-ray', 'Consultation with the Doctor or Nurse Practitioner (NP)', 'Separate Consultation with the Doctor or NP about Psychological Symptoms', and 'General' of the SFN service. Overall average patient satisfaction score was 8.7 (IQR 8-10) on a 1-to-10 rating scale. Main area for improvement was shortening the 8-week period for receiving the results of the diagnostic testing (p < 0.05). General health status was statistically significant associated with patient satisfaction (p < 0.05). CONCLUSION: A good reflection of the high patient satisfaction and -accessibility of the SFN-service is shown, with important points for improvement. These results could help hospitals widely to optimize the logistic and diagnostic pathway of SFN analysis, benchmarking patient satisfaction results among the hospitals, and to improve the quality of care of comparable SFN services.

Cost-effectiveness of ECPR versus CCPR in OHCA; A pre-planned, trial-based economic evaluation.

INTRODUCTION: When out-of-hospital cardiac arrest (OHCA) becomes refractory, extracorporeal cardiopulmonary resuscitation (ECPR) is a potential option to restore circulation and improve the patient's outcome. However, ECPR requires specific materials and highly skilled personnel, and it is unclear whether increased survival and health-related quality of life (HRQOL) justify these costs. METHODS: This cost-effectiveness study was part of the INCEPTION study, a multicenter, pragmatic randomized trial comparing hospital-based ECPR to conventional CPR (CCPR) in patients with refractory OHCA in 10 cardiosurgical centers in the Netherlands. We analyzed healthcare costs in the first year and measured HRQOL using the EQ-5D-5L at 1, 3, 6, and 12 months. Incremental cost-effectiveness ratio's (ICER), cost-effectiveness planes, and acceptability curves were calculated. Sensitivity analyses were performed for per-protocol and as-treated subgroups as well as imputed productivity loss in deceased patients. RESULTS: In total 132 patients were enrolled: 62 in the CCPR and 70 in the ECPR group. The difference in mean costs after one year was €5,109 (95%CI -7,264-15,764). Mean QALY after one year was 0.15 in the ECPR group and 0.11 in the CCPR group, resulting in an ICER of €121,643 per additional QALY gained. The acceptability curve shows that at a willingness-to-pay threshold of €80.000, the probability of ECPR being cost-effective compared to CCPR is 36%. Sensitivity analysis showed increasing ICER in the per-protocol and as-treated groups and lower probabilities of acceptance. CONCLUSION: Hospital-based ECPR in refractory OHCA has a low probability of being cost-effective in a trial-based economic evaluation.

Development, validation and feasibility of a Patient Satisfaction Questionnaire for evaluating the quality performance of a diagnostic small fibre neuropathy service: A qualitative study.

INTRODUCTION AND AIM: Small fibre neuropathy (SFN) is a peripheral neuropathy, leading to neuropathic pain and autonomic dysfunction. An evidence-based standardized patient diagnostic SFN service has been implemented in the Netherlands for improving patient-centred SFN care. However, the quality of care of this diagnostic SFN service has never been assessed from a patient perspective. The aim of this study was to develop and validate an SFN-Patient Satisfaction Questionnaire (SFN-PSQ) to measure the quality performance of a standardized diagnostic SFN service. METHODS: A descriptive qualitative study to create the SFN-PSQ was performed using the (COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist. For item generation and content development, domains and/or items from validated PSQs were selected. The content development and content validity were performed using a Delphi method with SFN expert caregivers with different backgrounds. By using the three-step-test method in individual cognitive interviews, the content validity by patients was finalized. RESULTS: In one online Delphi panel round, the content of the first concept of the SFN-PSQ was validated, which resulted in the second concept of the SFN-PSQ. From July 2019 till March 2020, nine patients consented to participate in the individual cognitive interviews. The most significant changes of the new questionnaire were adding domains and items concerning the waiting list, the diagnostic services and consultation by the hospital psychiatrist. Also, a differentiation was made for both an inpatient and outpatient diagnostic SFN service. Furthermore, the clarity and intelligibility of the domains/items were improved, resulting in an increased comprehension of the SFN-PSQ. Ultimately, the new developed SFN-PSQ consisted of 10 domains and 51 items, suitable for measuring patient satisfaction of the neurological analysis in patients with SFN. CONCLUSION: Through item generation, expert opinions and interviews with patients, the SFN-PSQ was developed and validated, and feasibility was confirmed. The structure of the questionnaire, based on the logistic and diagnostic SFN pathway, could be used as a model in other hospitals to improve the quality, continuity and access of SFN care and other chronic diseases taking into account potential cross-cultural differences. PATIENT OR PUBLIC CONTRIBUTION: Caregivers were involved in the item generation and content development of the questionnaire. Patients were directly involved in testing the content validity and feasibility of the SFN-PSQ. CLINICAL TRIAL REGISTRATION: Not applicable.

Surgical excision versus topical 5% 5-fluorouracil and photodynamic therapy in treatment of Bowen's disease: A multicenter randomized controlled trial.

BACKGROUND: Randomized controlled trials comparing the effectiveness of 5-fluorouracil cream, methylaminolevulinate photodynamic therapy (MAL-PDT) and surgical excision in patients with Bowen's disease are lacking. METHODS: In this multicenter noninferiority trial, patients with a histologically proven Bowen's disease of 4-40 mm were randomly assigned to excision with 5 mm margin, 5% 5-fluorouracil cream twice daily for 4 weeks, or 2 sessions of MAL-PDT with 1 week interval. The primary outcome was the proportion of patients with sustained clearance at 12 months after treatment. A noninferiority margin of 22% was used. RESULTS: Between May 2019 and January 2021, 250 patients were randomized. The proportion of patients with sustained clearance was 97.4% (75/77) after excision, 85.7% (66/77) after 5-fluorouracil, and 82.1% (64/78) after MAL-PDT. Absolute differences were -11.7% (95% CI -18.9 to -4.5; P = .0049) for 5-fluorouracil versus excision and -15.4% (95% CI -23.1 to -7.6; P = .00078) for MAL-PDT versus excision. Both noninvasive treatments significantly more often led to good or excellent cosmetic outcome. CONCLUSIONS: Based on our predefined noninferiority margin of 22%, 5-fluorourcail is noninferior to excision and associated with better cosmetic outcome. For MAL-PDT noninferiority to excision cannot be concluded. Therefore, 5-fluorouracil should be preferred over excision and MAL-PDT in treatment of Bowen's disease.

Effectiveness of a patient decision aid for patients with superficial basal cell carcinoma: A pre- and post-implementation study.

OBJECTIVE: This study evaluates whether using a patient decision aid (PDA) for patients with superficial basal-cell carcinoma (sBCC) results in a decreased decisional conflict level and increased knowledge. METHODS: In a prospective multicentre study, patient groups were included before and after implementation of a PDA. Decisional conflict levels were compared directly after making the treatment decision, measured once as the mean score on the decisional conflict scale (DCS). Higher scores correspond with higher conflict levels (0-100). Secondary outcomes were knowledge on treatment options, recognizing a BCC, and risk factors for developing a BCC measured on an adapted version of a validated knowledge questionnaire for melanoma patients, and patient satisfaction with the PDA. RESULTS: Data was available for 103 patients in the control-group and 109 in the PDA-group. The mean DCS score in the control-group was 22.78 (SD 14.76) compared to 22.34 (SD 14.54) in the PDA-group; the decrease was non-significant (p = 0.828). The average percentage correct answers on the knowledge questionnaire increased from 76.5% in the control-group to 80.5% in the PDA-group (p = 0.044). According to the majority of patients in the PDA-group (73.7%) the PDA had added value. CONCLUSION: Using the PDA had no significant effect on decisional conflict levels, but increased overall knowledge on relevant issues concerning sBCC. PRACTICE IMPLICATIONS: The PDA can be used as an informational tool by patients with sBCC.

Gynecologists' perspectives on surgical treatment for apical prolapse: a qualitative study.

INTRODUCTION AND HYPOTHESIS: Vaginal sacrospinous fixation (VSF) without mesh and sacrocolpopexy (SCP) with mesh are the most frequently performed surgical procedures for apical prolapse in the Netherlands. There is no long-term evidence suggesting the optimal technique, however. The aim was to identify which factors play a role in the choice between these surgical treatment options. METHODS: A qualitative study using semi-structured interviews amongst Dutch gynecologists was carried out. An inductive content analysis was performed with Atlas.ti. RESULTS: Ten interviews were analyzed. All gynecologists performed vaginal surgeries for apical prolapse, six gynecologists perform SCP themselves. Six gynecologists would perform VSF for a primary vaginal vault prolapse (VVP); three gynecologists preferred a SCP. All participants prefer a SCP for recurrent VVP. All participants have stated that multiple comorbidities could be a reason for choosing VSF, as this procedure is considered less invasive. Most participants choose a VSF in the case of older age (6 out of 10) or higher body mass index (7 out of 10). All treat primary uterine prolapse with vaginal, uterine-preserving surgery. CONCLUSIONS: Recurrent apical prolapse is the most important factor in advising patients which treatment they should undergo for VVP or uterine descent. Also, the patient's health status and the patient's own preference are important factors. Gynecologists who do not perform the SCP in their own clinic are more likely to perform a VSF and find more reasons not to advise a SCP. All participants prefer a vaginal surgery for a primary uterine prolapse.

A Social Network Analysis of Influences on Residents' Value-Based Decisions.

PURPOSE: To ensure a value-based health care system, it is becoming increasingly important that residents are trained in making value-based decisions. This study explored the social network influencing residents' value-based decisions. METHOD: To explore the social network influencing residents' value-based decisions, the authors used a semistructured individual and mini-group interviewing approach and participatory visual mapping. In total, 17 residents across 13 different specialties were interviewed from the southeastern postgraduate medical education and training region of the Netherlands, May-November 2021. Two researchers independently coded the transcribed data using an integrated inductive thematic approach. Subsequently, social network analysis was used to visualize the results. RESULTS: Residents indicated that their value-based decisions were influenced by direct actors who influenced decisions related to patients and indirect actors who shaped decisions related to patients without directly modifying them. Different interaction-aspects (i.e., personal, situational, and institutional) further affected residents' ability to make value-based decisions. Thus, residents' value-based decisions were a product of the interplay between various interactions with actors and different interaction-aspects. Residents defined value-based decisions differently, even within an interview. CONCLUSIONS: These results suggest residents' value-based decisions are influenced by a multitude of actors, including hierarchically superior colleagues who can directly alter decisions and patients (and their families) and nurses with whom residents consider it important to maintain good relationships. In addition, more experienced actors, mainly from the medical and nursing profession, contribute most to learning. Furthermore, residents' value-based decisions are deeply underpinned by the hidden curriculum. However, many senior physicians may not have received sufficient training in the concept of value-based health care. Consequently, an approach of formally educating residents in value-based health care will likely have limited effects unless social influences in day-to-day clinical settings reinforce its importance.

Endovascular treatment and neurosurgical clipping in subarachnoid hemorrhage: a systematic review of economic evaluations.

INTRODUCTION: There are two treatment modalities for aneurysmal subarachnoid hemorrhage: endovascular treatment (EVT) and neurosurgical clipping. Results of economic evaluations are needed to gain insight into the relationship between clinical effectiveness and costs of these treatment modalities. This important information can inform both clinical decision-making processes and policymakers in facilitating Value-Based Healthcare. EVIDENCE ACQUISITION: Databases (PubMed, Embase, Cochrane Library, the Centre for Reviews and Dissemination, EBSCO, and Web of Science) were searched for studies published until October 2020 that had performed economic evaluations in aneurysmal subarachnoid hemorrhage patients by comparing EVT with neurosurgical clipping. The quality of reporting and methodology of these evaluations was assessed using the associated instruments (i.e. CHEERS statement and CHEC-list, respectively). EVIDENCE SYNTHESIS: A total of 6 studies met the inclusion criteria. All included studies reported both effects and costs, however five did not relate effects to costs. Only one study related effects directly to costs, thus conducted a full economic evaluation. The reporting quality scored 81% and the methodological quality scored 30%. CONCLUSIONS: The quality of published cost-effectiveness studies on the treatment of aneurysmal subarachnoid hemorrhage is poor. Six studies reported both outcomes and costs, however only one study performed a full economic evaluation comparing EVT to neurosurgical clipping. Although the reporting quality was sufficient, the methodological quality was poor. Further research that relates health-related quality of life measures to costs of EVT and neurosurgical clipping is required - specifically focusing on both reporting and methodological quality. Different subgroup analyses and modeling could also enhance the findings.

In a Child's Shoes: Composite Time Trade-Off Valuations for EQ-5D-Y-3L with Different Proxy Perspectives.

BACKGROUND AND OBJECTIVES: EQ-5D-Y-3L health states are commonly valued by asking adults to complete stated preference tasks, 'given their views about a 10-year-old child' (hereafter referred to as proxy 1). The use of this perspective has been a source of debate. In this paper, we investigated an alternative proxy perspective: i.e. adults considered what they think a 10-year old-child would decide for itself (hereafter, proxy 2 (substitute)]. Our main objective was to explore how the outcomes, dispersion and response patterns of a composite time trade-off valuation differ between proxy 1 and proxy 2. METHODS: A team of four trained interviewers completed 402 composite time trade-off interviews following the EQ-5D-Y-3L protocol. Respondents were randomly allocated to value health states in either the proxy 1 or proxy 2 (substitute) perspective. Each respondent valued ten health states with the perspective they were assigned to, as well as one health state with the alternative perspective (33333). RESULTS: The use of different proxy perspectives yielded differences in EQ-5D-Y-3L valuation. For states in which children had considerable pain and were very worried, sad or unhappy, respondents' valuations were lower in proxy 1 than in proxy 2 (substitute) perspectives, by about 0.2. Within-subject variation across health states was lower for proxy 2 (substitute) than proxy 1 perspectives. Analyses of response patterns suggest that data for proxy 2 (substitute) perspectives were less clustered. CONCLUSIONS: There are systematic differences between composite time trade-off responses given by adults deciding for children and adults considering what children would want for themselves. In addition to warranting further qualitative exploration, such differences contribute to the ongoing normative discussion surrounding the source and perspective used for valuation of child and adolescent health.

Incorporating value-based healthcare projects in residency training: a mixed-methods study on the impact of participation on understanding and competency development.

OBJECTIVES: Stimulating the active participation of residents in projects with societally relevant healthcare themes, such as value-based healthcare (VBHC), can be a strategy to enhance competency development. Canadian Medical Education Directions for Specialists (CanMEDS) competencies such as leader and scholar are important skills for all doctors. In this study, we hypothesise that when residents conduct a VBHC project, CanMEDS competencies are developed. There is the added value of gaining knowledge about VBHC. DESIGN: An explorative mixed-methods study assessing residents' self-perceived learning effects of conducting VBHC projects according to three main components: (1) CanMEDS competency development, (2) recognition of VBHC dilemmas in clinical practice, and (3) potential facilitators for and barriers to implementing a VBHC project. We triangulated data resulting from qualitative analyses of: (a) text-based summaries of VBHC projects by residents and (b) semistructured interviews with residents who conducted these projects. SETTING: Academic and non-academic hospitals in the Netherlands. PARTICIPANTS: Out of 63 text-based summaries from residents, 56 were selected; and out of 19 eligible residents, 11 were selected for semistructured interviews and were included in the final analysis. RESULTS: Regarding CanMEDS competency development, the competencies 'leader', 'communicator' and 'collaborator' scored the highest. Opportunities to recognise VBHC dilemmas in practice were mainly stimulated by analysing healthcare practices from different perspectives, and by learning how to define costs and relate them to outcomes. Finally, implementation of VBHC projects is facilitated by a thorough investigation of a VBHC dilemma combined with an in-depth stakeholder analysis. CONCLUSION: In medical residency training programmes, competency development through active participation in projects with societally relevant healthcare themes-such as VBHC-was found to be a promising strategy. From a resident's perspective, combining a thorough investigation of the VBHC dilemma with an in-depth stakeholder analysis is key to the successful implementation of a VBHC project.

Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial.

BACKGROUND: Punch biopsy is the gold standard for diagnosis and subtyping of basal cell carcinoma. The aim of this study was to assess whether use of optical coherence tomography (OCT), a non-invasive imaging tool, might avoid the need for biopsy. METHODS: In a multicentre, randomised, non-inferiority trial, patients (aged ≥18 years) with an indication for biopsy of a suspected basal cell carcinoma outside the H-zone (high-risk zone) of the face were randomly assigned (1:1) to receive either OCT or punch biopsy (regular care) via a web-based randomisation system. Patients were enrolled from three participating centres in the Netherlands: Maastricht University Medical Centre+, Catharina Hospital Eindhoven, and Zuyderland Medical Centre Heerlen. Stratification factors for randomisation were participating centre and the grade of clinical basal cell carcinoma suspicion (high vs low). The primary endpoint was the proportion of patients free from a recurrent or residual lesion (malignant or premalignant) 12 months after treatment. Modified intention-to-treat and per-protocol analyses were conducted, with a predefined non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov number, NCT03848078, and is complete. FINDINGS: Between Feb 25, 2019, and Sept 2, 2020, 598 patients were enrolled and randomly assigned to either the regular care group (n=299) or the OCT group (n=299). Data on the primary endpoint were available in 553 patients (n=268 in the regular care group, n=285 in the OCT group). After median follow-up of 12·7 months (IQR 11·2-14·1) in the OCT group and 12·6 months (10·8-14·3) in the regular care group, 253 (94%) of 268 patients in the OCT group and 266 (93%) of 285 patients in the regular care group were free from recurrent or residual lesions (malignant or pre-malignant) 12 months after treatment. According to our modified intention-to-treat analysis, the absolute difference (OCT vs regular care) was 1·07% (95% CI -2·93 to 5·06; one-sided p=0·30), with the lower limit of the 95% CI not exceeding the predefined non-inferiority margin of -10%. Per-protocol analyses led to proportions free from a residual or recurrent lesion (premalignant or malignant) of 95% (250 of 263) in the OCT group and 94% (262 of 278) in the regular care group, and an absolute difference of 0·81% (95% CI -2·98 to 4·60; one-sided p=0·34). INTERPRETATION: OCT-guided diagnosis and treatment of basal cell carcinoma is non-inferior to regular care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures. FUNDING: The Netherlands Organization for Health Research and Development and Maurits en Anna de Kock Stichting.

Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Treatment of actinic keratosis (AK) aims to prevent cutaneous squamous cell carcinoma (cSCC). However, whether AK can progress into invasive cSCC is a matter of debate, and little is known about the effect of treatment on preventing cSCC. Objectives: To evaluate the risk of invasive cSCC and factors that may contribute to increased risk in patients with multiple AKs. Design, Setting, and Participants: In this secondary analysis of a multicenter randomized clinical trial, 624 patients with a minimum of 5 AKs within an area of 25 to 100 cm2 on the head were recruited from the Department of Dermatology of 4 hospitals in the Netherlands. Long-term follow-up was performed from July 1, 2019, to December 31, 2020. Interventions: Patients were randomized to treatment with 5% fluorouracil, 5% imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015% ingenol mebutate gel. Main Outcomes and Measures: The primary outcome was the proportion of patients with invasive cSCC in the target area during follow-up. Secondary outcomes were the associations between risk of invasive cSCC and a priori defined potential prognostic factors, including type of treatment, severity of AK (Olsen grade), history of nonmelanoma skin cancer, and additional treatment. Results: Of the 624 patients (558 [89.4%] male; median age, 73 years [range, 48-94 years]) in the study, 26 were diagnosed with a histologically proven invasive cSCC in the target area during follow-up. The total 4-year risk of developing cSCC in a previously treated area of AK was 3.7% (95% CI, 2.4%-5.7%), varying from 2.2% (95% CI, 0.7%-6.6%) in patients treated with fluorouracil to 5.8% (95% CI, 2.9%-11.3%) in patients treated with imiquimod. In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, risk of invasive cSCC was highest in patients with Olsen grade III AK and was substantially increased in patients who received additional treatment. These patients should be closely followed up after treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT02281682.

Discrete Choice Experiment Reveals Strong Preference for Dietary Treatment Among Patients With Irritable Bowel Syndrome.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is a highly prevalent, chronic disorder of the gut-brain interaction that significantly affects quality of life. Several treatments, with comparable clinical efficacy, are available. Patient preferences can therefore be an important determinant of an effective management strategy. Treatment preferences of patients regarding decision making remain unclear. We aimed to examine these preferences and estimate trade-offs between different attributes. METHODS: A total of 427 patients from the Maastricht IBS cohort were invited to participate. A labeled discrete choice experiment survey, containing 9 scenarios with each 3 alternatives (medication, diet, psychotherapy), was developed in order to estimate preferences. The treatment scenarios were based on 6 attributes: effectiveness, time to response, time until recurrence, side effects, time required, and frequency of appointments. The preference weights and relative importance were analyzed using a mixed logit model. RESULTS: A total of 185 (43.3%) of 427 potential respondents completed the questionnaire (mean age 49.51 years, 69.2% female). The most preferred treatment was dietary intervention (48.1%), followed by pharmacotherapy (29.2%) and psychotherapy (22.7%). IBS patients preferred a higher effectiveness, shorter time interval to response, longer time interval until recurrence, no severe side effects, and frequent appointments when attending psychotherapy. Younger patients (≤50 years of age) preferred dietary interventions and a long period until recurrence, whereas older patients (>50 years of age) were more inclined to choose pharmacotherapy and the period until recurrence was not important. CONCLUSIONS: Dietary interventions were the most preferred IBS therapy. Identifying patients' treatment preferences during shared decision making will provide more optimal management strategies and could be the best approach to diminish disease burden.

The ICEpop Capability Measure for Adults Instrument for Capabilities: Development of a Tariff for the Dutch General Population.

OBJECTIVES: The ICEpop Capability Measure for Adults (ICECAP-A) assesses 5 capabilities (stability, attachment, autonomy, achievement, and enjoyment) that are important to one's quality of life and might be an important addition to generic health questionnaires currently used in economic evaluations. This study aimed to develop a Dutch tariff of the Dutch translation of the ICECAP-A. METHODS: The methods used are similar to those used in the development of the UK tariff. A profile case best-worst scaling task was presented to 1002 participants from the general Dutch population. A scale-adjusted latent class analysis was performed to test for preferences of ICECAP-A capabilities and scale heterogeneity. RESULTS: A 3-preference class 2-scale class model with worst choice as scale predictor was considered optimal and was used to calculate the resulting tariff. Results indicated that the capabilities stability, attachment, and enjoyment were considered more important aspects of quality of life than autonomy and achievement. Additionally, improving capabilities from low to moderate levels had a larger effect on quality of life than improving capabilities that were already at a higher level. CONCLUSIONS: The ICECAP-A tariffs found in this study could be used in economic evaluations of healthcare interventions in The Netherlands.

The ICECAP-A instrument for capabilities: assessment of construct validity and test-retest reliability in a general Dutch population.

PURPOSE: The ICEpop CAPability measure for Adults (ICECAP-A) assesses five capabilities that are important to one's well-being. The instrument might be an important addition to generic health questionnaires when evaluating quality of life extending beyond health. This study aimed to conduct a psychometric assessment of the Dutch translation of the ICECAP-A. METHODS: Construct validity of the instrument was assessed in two ways. First, by measuring correlations with the EQ-5D-5L questionnaire and a measure of self-efficacy and, second, by investigating the ability to distinguish between groups known to differ on the construct the ICECAP-A means to capture. Additionally, test-retest reliability was evaluated. RESULTS: In total, 1002 participants representative of the general Dutch population completed an online survey. For test-retest reliability, 252 participants completed the same questionnaire 2 weeks later. The ICECAP-A indicated moderate to strong correlations with the EQ-5D-5L and a strong correlation with self-efficacy. Furthermore, it was capable of differentiating known groups. Moreover, results indicated adequate test-retest reliability with an intraclass correlation coefficient of 0.79. CONCLUSION: In summary, results suggest adequate test-retest reliability and construct validity and indicate that the ICECAP-A might be of added value, especially when considering areas outside of the traditional health intervention model.

The estimation of a preference-based single index for the IBS-QoL by mapping to the EQ-5D-5L in patients with irritable bowel syndrome.

PURPOSE: The Irritable Bowel Syndrome Quality of Life (IBS-QoL) questionnaire is a commonly used and validated IBS-specific QoL instrument. However, this questionnaire is in contrast to the EQ-5D-5L, not preference-based and as such does not allow calculation of QALYs. The objective of this study was to describe the convergent- and known-group validity of both questionnaires and to develop a mapping algorithm from EQ-5D-5L which enable IBS-QoL scores to be transformed into utility scores for use in economic evaluations. METHODS: We used data from two multicenter randomized clinical trials, which represented the estimation and external validation dataset. The convergent validity was investigated by examining correlations between the EQ-5D-5L and IBS-QoL and the known-group validity by calculating effect sizes. Ordinary least squares (OLS), censored least absolute deviations (CLAD), and mixture models were used in this mapping approach. RESULTS: 283 IBS patients were included (n = 189 vs. n = 84). Mean IBS-QoL score was 71.13 (SD 15.66) and mean EQ-5D-5L utility score was 0.73 (SD 0.19). The overall sensitivity of the IBS-QoL and EQ-5D-5L to discriminate between patient and disease characteristics was similar. CLAD model 4, containing the total IBS-QoL score and squared IBS-SSS (IBS severity scoring system), was chosen as the most appropriate model to transform IBS-QoL scores into EQ-5D-5L utility scores. CONCLUSION: This study reports the development of an algorithm where the condition-specific questionnaire IBS-QoL can be used to calculate utility values for use in economic evaluations. Including a clinical measure, IBS-SSS, in the model improved the performance of the algorithm.