Patient preference for radial versus femoral vascular access for elective coronary procedures: The PREVAS study.

OBJECTIVES: To explore patient preference for vascular access site in percutaneous coronary procedures, the perceived importance of benefits and risks of transradial access (TRA) and transfemoral access (TFA) were assessed. In addition, direct preference for vascular access and preference for shared decision making (SDM) were evaluated. BACKGROUND: TRA has gained significant ground on TFA during the last decades. Surveys on patient preference have mostly been performed in dedicated TRA trials. METHODS: In the PREVAS study (Clinicaltrials.gov: NCT02625493) a stated preference elicitation method best-worst scaling (BWS) was used to determine patient preference for six treatment attributes: bleeding, switch of access-site, postprocedural vessel quality, mobilization and comfort, and over-night stay. Based on software-generated treatment scenarios, 142 patients indicated which characteristics they perceived most and least important in treatment choice. Best-minus-Worst scores and attribute importance were calculated. RESULTS: Bleeding risk was considered most important (attribute importance 31.3%), followed by length of hospitalization (22.6%), and mobilization(20.2%). Most patients preferred the approach of their current procedure (85.9%); however, 71.1% of patients with experience with both access routes favored TRA (P < 0.001). Most patients (38.0%) appreciated SDM, balanced between patient and cardiologist. CONCLUSIONS: Patients appreciate lower bleeding risk and early ambulation, factors favoring TRA. Previous experience with a single access route has a major impact on preference, while experience with both routes generally resulted in preference for TRA. Most patients prefer balanced SDM. © 2017 The Authors Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc.

Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials.

OBJECTIVES: To examine patients' perspectives regarding composite endpoints and the utility patients put on possible adverse outcomes of revascularization procedures. DESIGN: In the PRECORE study, a stated preference elicitation method Best-Worst Scaling (BWS) was used to determine patient preference for 8 component endpoints (CEs): need for redo percutaneous coronary intervention (PCI) within 1 year, minor stroke with symptoms <24 hours, minor myocardial infarction (MI) with symptoms <3 months, recurrent angina pectoris, need for redo coronary artery bypass grafting (CABG) within 1 year, major MI causing permanent disability, major stroke causing permanent disability and death within 24 hours. SETTING: A tertiary PCI/CABG centre. PARTICIPANTS: One hundred and sixty patients with coronary artery disease who underwent PCI or CABG. MAIN OUTCOME MEASURES: Importance weights (IWs). RESULTS: Patients considered need for redo PCI within 1 year (IW: 0.008), minor stroke with symptoms <24 hours (IW: 0.017), minor MI with symptoms <3 months (IW: 0.027), need for redo CABG within 1 year (IW: 0.119), recurrent angina pectoris (IW: 0.300) and major MI causing permanent disability (IW: 0.726) less severe than death within 24 hours (IW: 1.000). Major stroke causing permanent disability was considered worse than death within 24 hours (IW: 1.209). Ranking of CEs and the relative values attributed to the CEs differed among subgroups based on gender, age and educational level. CONCLUSION: Patients attribute different weight to individual CEs. This has significant implications for the interpretation of clinical trial data.

Valuing Treatments for Parkinson Disease Incorporating Process Utility: Performance of Best-Worst Scaling, Time Trade-Off, and Visual Analogue Scales.

OBJECTIVE: The objective of this study was to compare treatment profiles including both health outcomes and process characteristics in Parkinson disease using best-worst scaling (BWS), time trade-off (TTO), and visual analogue scales (VAS). METHODS: From the model comprising of seven attributes with three levels, six unique profiles were selected representing process-related factors and health outcomes in Parkinson disease. A Web-based survey (N = 613) was conducted in a general population to estimate process-related utilities using profile-based BWS (case 2), multiprofile-based BWS (case 3), TTO, and VAS. The rank order of the six profiles was compared, convergent validity among methods was assessed, and individual analysis focused on the differentiation between pairs of profiles with methods used. RESULTS: The aggregated health-state utilities for the six treatment profiles were highly comparable for all methods and no rank reversals were identified. On the individual level, the convergent validity between all methods was strong; however, respondents differentiated less in the utility of closely related treatment profiles with a VAS or TTO than with BWS. For TTO and VAS, this resulted in nonsignificant differences in mean utilities for closely related treatment profiles. CONCLUSIONS: This study suggests that all methods are equally able to measure process-related utility when the aim is to estimate the overall value of treatments. On an individual level, such as in shared decision making, BWS allows for better prioritization of treatment alternatives, especially if they are closely related. The decision-making problem and the need for explicit trade-off between attributes should determine the choice for a method.

Insufficient vitamin D supplement use during pregnancy and early childhood: a risk factor for positional skull deformation.

Vitamin D insufficiency during pregnancy is associated with disturbed skeletal homeostasis during infancy. Our aim was to investigate the influence of adherence to recommendations for vitamin D supplement intake of 10 µg per day (400 IU) during pregnancy (mother) and in the first months of life (child) on the occurrence of positional skull deformation of the child at the age of 2 to 4 months. In an observational case-control study, two hundred seventy-five 2- to 4-month-old cases with positional skull deformation were compared with 548 matched controls. A questionnaire was used to gather information on background characteristics and vitamin D intake (food, time spent outdoors and supplements). In a multiple variable logistic regression analysis, insufficient vitamin D supplement intake of women during the last trimester of pregnancy [adjusted odds ratio (aOR) 1.86, 95% (CI) 1.27-2.70] and of children during early infancy (aOR 7.15, 95% CI 3.77-13.54) were independently associated with an increased risk of skull deformation during infancy. These associations were evident after adjustment for the associations with skull deformation that were present with younger maternal age and lower maternal education, shorter pregnancy duration, assisted vaginal delivery, male gender and milk formula consumption after birth. Our findings suggest that non-adherence to recommendations for vitamin D supplement use by pregnant women and infants are associated with a higher risk of positional skull deformation in infants at 2 to 4 months of age. Our study provides an early infant life example of the importance of adequate vitamin D intake during pregnancy and infancy.

Clarifying Values: An Updated and Expanded Systematic Review and Meta-Analysis.

BACKGROUND: Patient decision aids should help people make evidence-informed decisions aligned with their values. There is limited guidance about how to achieve such alignment. PURPOSE: To describe the range of values clarification methods available to patient decision aid developers, synthesize evidence regarding their relative merits, and foster collection of evidence by offering researchers a proposed set of outcomes to report when evaluating the effects of values clarification methods. DATA SOURCES: MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, and CINAHL. STUDY SELECTION: We included articles that described randomized trials of 1 or more explicit values clarification methods. From 30,648 records screened, we identified 33 articles describing trials of 43 values clarification methods. DATA EXTRACTION: Two independent reviewers extracted details about each values clarification method and its evaluation. DATA SYNTHESIS: Compared to control conditions or to implicit values clarification methods, explicit values clarification methods decreased the frequency of values-incongruent choices (risk difference, -0.04; 95% confidence interval [CI], -0.06 to -0.02; P < 0.001) and decisional conflict (standardized mean difference, -0.20; 95% CI, -0.29 to -0.11; P < 0.001). Multicriteria decision analysis led to more values-congruent decisions than other values clarification methods (χ2 = 9.25, P = 0.01). There were no differences between different values clarification methods regarding decisional conflict (χ2 = 6.08, P = 0.05). LIMITATIONS: Some meta-analyses had high heterogeneity. We grouped values clarification methods into broad categories. CONCLUSIONS: Current evidence suggests patient decision aids should include an explicit values clarification method. Developers may wish to specifically consider multicriteria decision analysis. Future evaluations of values clarification methods should report their effects on decisional conflict, decisions made, values congruence, and decisional regret.

Heterogeneity in Preferences for Anti-coagulant Use in Atrial Fibrillation: A Latent Class Analysis.

INTRODUCTION: Recent reviews on patients' preferences towards attributes of oral anti-coagulant therapy have shown that preference for convenience of therapy is heterogeneous. In this study, we used a novel approach-latent class analysis (LCA)-to assess heterogeneity. METHODS: We developed a health preference survey that consisted of 12 discrete choice questions. The following attributes of convenience were included: intake frequency; need for regular coagulation monitoring; diet or drug interactions; relation between medication and food intake; and pill type. Background questions about gender, age, current therapy [i.e., direct-acting oral anti-coagulant (DOAC) or vitamin K antagonist (VKA)], self-reported medication adherence, and pill burden were included. Mixed logit analysis (MLA) and LCA were performed. The scale-adjusted LCA model with two scale classes and four preference classes emerged as the model with the best fit and interpretability. RESULTS: A total of 508 patients with non-valvular atrial fibrillation from five European countries (Germany, Italy, Spain, France, and the UK) were surveyed in August 2017. The most important attributes were need for monitoring (37%) and intake frequency (27%). Patient preferences were significantly influenced by country, gender, and current anti-coagulant therapy. Four different preference classes of patients were identified in the LCA. First, most patients (57%) were in the "no need for regular coagulation monitoring" class. Current DOAC users and patients who were the least adherent to therapy were more likely to prefer no coagulation monitoring. Second, 20% of patients were in the "balanced" class of patients. Current VKA users with moderate adherence were more likely to be in this class. Patients who reported the lowest adherence were most likely in the "once daily, interactions likely" class (16%). Fourth, current VKA users and highly adherent patients were most likely to prefer therapies with a need for regular coagulation monitoring (7%). CONCLUSIONS: This study demonstrated significant preference heterogeneity among patients with atrial fibrillation and linked these preferences to differences in background characteristics. Country of residence and currently prescribed therapy influenced patient preferences in both the MLA and LCA models.

Development and usability testing of a multi-criteria value clarification methods for patients with localized prostate cancer.

Current guidelines for the development of decision aids recommend that they have to include a process for helping patients clarify their personal values, for example, by using values clarification methods. In this article, we extensively described the development process of the web-based values clarification method for patients with localized low- to intermediate-risk prostate cancer based on the analytic hierarchy process. With analytic hierarchy process, the relative importance of different attributes of available treatments can be determined through series of pairwise comparisons of potential outcomes. Furthermore, analytic hierarchy process is able to use this information to present respondents with a quantitative overall treatment score and can therefore give actual treatment advice upon patients' request. The addition of this values clarification method to an existing web-based treatment decision aid for patients with localized prostate cancer is thought to improve the support offered to patients in their decision-making process and their decision quality.

Individual Value Clarification Methods Based on Conjoint Analysis: A Systematic Review of Common Practice in Task Design, Statistical Analysis, and Presentation of Results.

BACKGROUND: There is an increased practice of using value clarification exercises in decision aids that aim to improve shared decision making. Our objective was to systematically review to which extent conjoint analysis (CA) is used to elicit individual preferences for clinical decision support. We aimed to identify the common practices in the selection of attributes and levels, the design of choice tasks, and the instrument used to clarify values. METHODS: We searched Scopus, PubMed, PsycINFO, and Web of Science to identify studies that developed a CA exercise to elicit individual patients' preferences related to medical decisions. We extracted data on the above-mentioned items. RESULTS: Eight studies were identified. Studies included a fixed set of 4-8 attributes, which were predetermined by interviews, focus groups, or literature review. All studies used adaptive conjoint analysis (ACA) for their choice task design. Furthermore, all studies provided patients with their preference results in real time, although the type of outcome that was presented to patients differed (attribute importance or treatment scores). Among studies, patients were positive about the ACA exercise, whereas time and effort needed from clinicians to facilitate the ACA exercise were identified as the main barriers to implementation. DISCUSSION: There is only limited published use of CA exercises in shared decision making. Most studies resembled each other in design choices made, but patients received different feedback among studies. Further research should focus on the feedback patients want to receive and how the CA results fit within the patient-physician dialogue.

Perceived advantages and disadvantages of oral anticoagulants, and the trade-offs patients make in choosing anticoagulant therapy and adhering to their drug regimen.

OBJECTIVE: The objective of this study was to explore the perceived advantages and disadvantages of oral anticoagulant therapies (OAT), and the trade-offs patients make in choosing therapy and adhering to their drug regimen. METHODS: Five focus group sessions were conducted across Europe among patients with atrial fibrillation to identify the most important factors impacting OAT's value and adherence. RESULTS: The most frequently identified barriers to OAT were lack of knowledge; poor patient-physician relationships; distraction due to employment or social environment; prior bleeding event(s) or the fear of bleeding; and changes in routine. Factors identified as promoting adherence included patients' personality, motivation, attitudes, and medication-taking habits and routines, as well as good quality health services. Inconvenient aspects of vitamin-K antagonists, such as regular blood monitoring and diet restrictions, were not reported to influence adherence, but may trigger patients to switch to direct oral anticoagulants. CONCLUSION: Most patients reported that a mixture of modifiable and non-modifiable factors helps them to take their drugs as prescribed. Individual patients' particular needs and preferences regarding OAT vary. PRACTICE IMPLICATIONS: OAT adherence can be promoted if therapies are tailored to patients' needs and preferences. Patients should be supported to share their preferences with their clinician.

Patients' Priorities for Oral Anticoagulation Therapy in Non-valvular Atrial Fibrillation: a Multi-criteria Decision Analysis.

INTRODUCTION: Effectiveness of oral anticoagulants (OACs) is critically dependent on patients' adherence to intake regimens. We studied the relative impact of attributes related to effectiveness, safety, convenience, and costs on the value of OAC therapy from the perspective of patients with non-valvular atrial fibrillation. METHODS: Four attributes were identified by literature review and expert interviews: effectiveness (risk of ischemic stroke), safety (risk of major bleeding, minor bleeding, gastrointestinal complaints), convenience (intake frequency, diet restrictions, international normalized ratio [INR] blood monitoring, pill type/intake instructions), and out-of-pocket costs. Focus groups were held in Spain, Germany, France, Italy and the United Kingdom (N = 48) to elicit patients' preferences through the use of the analytical hierarchy process method. RESULTS: Effectiveness (60%) and side effects (27%) have a higher impact on the perceived value of OACs than drug convenience (7%) and out-of-pocket costs (6%). As for convenience, eliminating monthly INR monitoring was given the highest priority (40%), followed by reducing diet restrictions (27%), reducing intake frequency (17%) and improving the pill type/intake instructions (15%). The most important side effect was major bleeding (75%), followed by minor bleeding (15%) and gastrointestinal complaints (10%). Furthermore, 71% of patients preferred once-daily intake to twice-daily intake. DISCUSSION: Although the relative impact of convenience on therapy value is small, patients have different preferences for options within convenience criteria. Besides considerations on safety and effectiveness, physicians should also discuss attributes of convenience with patients, as it can be assumed that alignment to patient preferences in drug prescription and better patient education could result in higher adherence.

Patient and Public Preferences for Treatment Attributes in Parkinson's Disease.

BACKGROUND: Patient and public preferences for therapeutic outcomes or medical technologies are often elicited, and discordance between the two is frequently reported. OBJECTIVE: Our main objective was to compare patient and public preferences for treatment attributes in Parkinson's disease (PD). METHODS: A representative sample from Dutch PD patients and the general public were invited to complete a best-worst scaling case 2 experiment consisting of six health-related outcomes and one attribute describing the specific treatment (brain surgery, pump, oral medication). Data were analyzed using mixed logit models, and attribute impact was estimated and compared between populations (and population subgroups). RESULTS: Both the public (N = 276) and patient (N = 198) populations considered treatment modality the most important attribute, although patients assigned higher relative importance. Both groups assigned high disutility to pump infusion and brain surgery and preferred drug treatment. Most health outcomes were valued equally by patients and the public, with the exception of reducing dizziness (more important to the public) and improving slow movement (more important to patients). DISCUSSION: Although these data do not support definite conclusions on whether patients are less likely to undergo invasive treatments, the (predicted) choice probability of undergoing brain surgery or having pump infusion technology would be low based on the (un)desirability of the attribute levels. Patients with PD might have adapted to their condition and are not willing to undergo advanced treatments in order to receive health improvements. Both public and patient preferences entail information that is potentially relevant for decision makers, and patient preferences can inform decision makers about the likelihood of adaptation to a specific condition.

Involving Patients in Weighting Benefits and Harms of Treatment in Parkinson's Disease.

INTRODUCTION: Little is known about how patients weigh benefits and harms of available treatments for Parkinson's Disease (oral medication, deep brain stimulation, infusion therapy). In this study we have (1) elicited patient preferences for benefits, side effects and process characteristics of treatments and (2) measured patients' preferred and perceived involvement in decision-making about treatment. METHODS: Preferences were elicited using a best-worst scaling case 2 experiment. Attributes were selected based on 18 patient-interviews: treatment modality, tremor, slowness of movement, posture and balance problems, drowsiness, dizziness, and dyskinesia. Subsequently, a questionnaire was distributed in which patients were asked to indicate the most and least desirable attribute in nine possible treatment scenarios. Conditional logistic analysis and latent class analysis were used to estimate preference weights and identify subgroups. Patients also indicated their preferred and perceived degree of involvement in treatment decision-making (ranging from active to collaborative to passive). RESULTS: Two preference patterns were found in the patient sample (N = 192). One class of patients focused largely on optimising the process of care, while the other class focused more on controlling motor-symptoms. Patients who had experienced advanced treatments, had a shorter disease duration, or were still employed were more likely to belong to the latter class. For both classes, the benefits of treatment were more influential than the described side effects. Furthermore, many patients (45%) preferred to take the lead in treatment decisions, however 10.8% perceived a more passive or collaborative role instead. DISCUSSION: Patients weighted the benefits and side effects of treatment differently, indicating there is no "one-size-fits-all" approach to choosing treatments. Moreover, many patients preferred an active role in decision-making about treatment. Both results stress the need for physicians to know what is important to patients and to share treatment decisions to ensure that patients receive the treatment that aligns with their preferences.