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

Introduction: Parents 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 analysis: Parents 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 dissemination: This 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 number: NCT04437069 (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

Understanding vaccine hesitancy in Canada: Results of a consultation study by the Canadian Immunization Research Network

"Vaccine hesitancy" is a concept now frequently used in vaccination discourse. The increased popularity of this concept in both academic and public health circles is challenging previously held perspectives that individual vaccination attitudes and behaviours are a simple dichotomy of accept or reject. A consultation study was designed to assess the opinions of experts and health professionals concerning the definition, scope, and causes of vaccine hesitancy in Canada. We sent online surveys to two panels (1- vaccination experts and 2- front-line vaccine providers). Two questionnaires were completed by each panel, with data from the first questionnaire informing the development of questions for the second. Our participants defined vaccine hesitancy as an attitude (doubts, concerns) as well as a behaviour (refusing some / many vaccines, delaying vaccination). Our findings also indicate that both vaccine experts and front-line vaccine providers have the perception that vaccine rates have been declining and consider vaccine hesitancy an important issue to address in Canada. Diffusion of negative information online and lack of knowledge about vaccines were identified as the key causes of vaccine hesitancy by the participants. A common understanding of vaccine hesitancy among researchers, public health experts, policy-makers and health care providers will better guide interventions that can more effectively address vaccine hesitancy within Canada

Combining deliberation and intuition in patient decision support

Objective To review the strengths and weaknesses of deliberative and intuitive processes in the context of patient decision support and to discuss implications for decision aid (DA) design. Methods Conceptual review of the strengths and weaknesses of intuitive and analytical decision making and applying these findings to the practice of DA design. Results DAs combine several important goals: providing information, helping to clarify treatment related values, supporting preference construction processes, and facilitating more active engagement in decision making. Many DAs encourage patients to approach a decision analytically, without solid theoretical or empirical grounding for this approach. Existing research in other domains suggests that both intuition and deliberation may support decision making. We discuss implications for patient decision support and challenge researchers to determine when combining these processes leads to better outcomes. Conclusions Intuitive and analytical decision processes may have complementary effects in achieving the desired outcomes of patient decision support. Practice implications DA developers should be aware that tools solely targeted at supporting deliberation may limit DA effectiveness and harm preference construction processes. Patients may be better served by combined strategies that draw on the strengths and minimize the weaknesses of both deliberative and intuitive processes. Keywords: Patient decision aids (DAs), Values clarification methods (VCMs), Preference construction, Decision making, Intuition, Deliberatio

Trust in deliberation: The consequences of deliberative decision strategies for medical decisions

Oblective: Decision aids (DAs) play an increasingly critical role in supporting patients in making preference-sensitive treatment decisions. One largely untested assumption of DA design is that patients should be encouraged to deliberate carefully about their options after being informed of those options. The purpose of the present research is to test the impact of deliberative versus intuitive decision strategies in medical decision contexts. Methods: In 3 experiments, participants were randomly assigned to make a hypothetical medical decision either intuitively, or using various deliberative strategies. In Study 1, we predicted that deliberation would improve decision confidence while not changing decisions. In Study 2, our aim was to establish whether the observed increase in confidence was due to decision-making effort, confirmation bias, or both. In Study 3, it was predicted that deliberation would cause participants to become more confident in suboptimal decisions. Results: Across 3 studies, participants who deliberated felt better about their decisions and decision process, even when the decision was the same as what would have been chosen intuitively (Studies 1 and 2), and even when the decision was normatively bad (Study 3). Study 2 additionally indicated that participants' confidence was driven by confirmation bias rather than effort justification. Conclusions: Deliberative tasks may often fail to be an effective debiasing tool, and components of patient decision aids that ask patients to deliberate may serve to improve how patients feel without improving the quality of their decisions

Implementation and Evaluation of a Wiki Involving Multiple Stakeholders Including Patients in the Promotion of Best Practices in Trauma Care: The WikiTrauma Interrupted Time Series Protocol

Contains fulltext : 152344.pdf (publisher's version ) (Open Access)BACKGROUND: Trauma is the most common cause of mortality among people between the ages of 1 and 45 years, costing Canadians 19.8 billion dollars a year (2004 data), yet half of all patients with major traumatic injuries do not receive evidence-based care, and significant regional variation in the quality of care across Canada exists. Accordingly, our goal is to lead a research project in which stakeholders themselves will adapt evidence-based trauma care knowledge tools to their own varied institutional contexts and cultures. We will do this by developing and assessing the combined impact of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma. WikiTrauma has the potential to ensure that all stakeholders (eg, patients, clinicians, and decision makers) can all contribute to, and benefit from, evidence-based clinical knowledge about trauma care that is tailored to their own needs and clinical setting. OBJECTIVE: Our main objective will be to study the combined effect of WikiTrauma and Wiki101 on the quality of care in four trauma centers in Quebec. METHODS: First, we will pilot-test the wiki with potential users to create a version ready to test in practice. A rapid, iterative prototyping process with 15 health professionals from nonparticipating centers will allow us to identify and resolve usability issues prior to finalizing the definitive version for the interrupted time series. Second, we will conduct an interrupted time series to measure the impact of our combined intervention on the quality of care in four trauma centers that will be selected-one level I, one level II, and two level III centers. Participants will be health care professionals working in the selected trauma centers. Also, five patient representatives will be recruited to participate in the creation of knowledge tools destined for their use (eg, handouts). All participants will be invited to complete the Wiki101 training and then use, and contribute to, WikiTrauma for 12 months. The primary outcome will be the change over time of a validated, composite, performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry. RESULTS: This project was funded in November 2014 by the Canadian Medical Protective Association. We expect to start this trial in early 2015 and preliminary results should be available in June 2016. Two trauma centers have already agreed to participate and two more will be recruited in the next months. CONCLUSIONS: We expect that this study will add important and unique evidence about the effectiveness, safety, and cost savings of using collaborative platforms to adapt knowledge implementation tools across jurisdictions