Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect

IntroductionParents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter.Methods and analysisParents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision.Ethics and disseminationThis study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals.Trial registration numberNCT04437069 (Pre-results).

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.

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

BackgroundPatient decision aids should help people make evidence-informed decisions aligned with their values. There is limited guidance about how to achieve such alignment.PurposeTo 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 SourcesMEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, CINAHLStudy SelectionWe included articles that described randomized trials of one or more explicit values clarification methods. From 30,648 records screened, we identified 33 articles describing trials of 43 values clarification methods.Data ExtractionTwo independent reviewers extracted details about each values clarification method and its evaluation.Data SynthesisCompared to control conditions or to implicit values clarification methods, explicit values clarification methods decreased the frequency of values-disgruent choices (risk difference -0.04 95% CI [-0.06 to -0.02], p<.001) and decisional regret (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 (Chi-squared(2)=9.25, p=.01). There were no differences between different values clarification methods regarding decisional conflict (Chi-squared(2)=6.08, p=.05).LimitationsSome meta-analyses had high heterogeneity. We grouped values clarification methods into broad categories.ConclusionsCurrent 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.

Observer Ratings of Shared Decision Making Do Not Match Patient Reports: An Observational Study in 5 Family Medicine Practices

Background Measuring shared decision making (SDM) in clinical practice is important to improve the quality of health care. Measurement can be done by trained observers and by people participating in the clinical encounter, namely, patients. This study aimed to describe the correlations between patients’ and observers’ ratings of SDM using 2 validated and 2 nonvalidated SDM measures in clinical consultations. Methods In this cross-sectional study, we recruited 238 complete dyads of health professionals and patients in 5 university-affiliated family medicine clinics in Canada. Participants completed self-administered questionnaires before and after audio-recorded medical consultations. Observers rated the occurrence of SDM during medical consultations using both the validated OPTION-5 (the 5-item “observing patient involvement” score) and binary questions on risk communication and values clarification (RCVC-observer). Patients rated SDM using both the 9-item Shared Decision-Making Questionnaire (SDM-Q9) and binary questions on risk communication and values clarification (RCVC-patient). Results Agreement was low between observers’ and patients’ ratings of SDM using validated OPTION-5 and SDM-Q9, respectively (ρ = 0.07; P = 0.38). Observers’ ratings using RCVC-observer were correlated to patients’ ratings using either SDM-Q9 ( rpb = −0.16; P = 0.01) or RCVC-patients ( rpb = 0.24; P = 0.03). Observers’ OPTION-5 scores and patients’ ratings using RCVC-questions were moderately correlated ( rφ = 0.33; P = 0.04). Conclusion There was moderate to no alignment between observers’ and patients’ ratings of SDM using both validated and nonvalidated measures. This lack of strong correlation emphasizes that observer and patient perspectives are not interchangeable. When assessing the presence, absence, or extent of SDM, it is important to clearly state whose perspectives are reflected.

Group Counseling with Values Clarification Techniques to Increase Students' Respect

Individuals must own respect because it can be an internal controller in making logical decisions to behave by moral values. This study aimed to confirm the effectiveness of the values clarification group counselling on respect. This study used a repeated measure experimental design. The subjects in this study were 10 students at SMK Negeri 2 Mataram who indicated having a low category of respect. Data were collected using a respectful attitude questionnaire. Data analysis used repeated measure statistics ANOVA. The results of this study indicate that values clarification group counselling is effective in increasing student respect. Students' understanding regarding respect is inseparable from how to create good relationships between students and teachers as a form of creating a healthy and conducive school climate.