A patient decision aid for risk-reducing surgery in premenopausal BRCA1/2 mutation carriers: Development process and pilot testing

Background: BRCA1/2 mutation carriers’ choice between risk-reducing salpingo-oophorectomy (RRSO) and salpingectomy with delayed oophorectomy is very complex. Aim was to develop a patient decision aid that combines evidence with patient preferences to facilitate decision making. Design: Systematic development of a patient decision aid in an iterative process of prototype development, alpha testing by patients and clinicians and revisions using International Patient Decision Aid Standards (IPDAS) quality criteria. Information was based on the available literature and current guidelines. A multidisciplinary steering group supervised the process. Setting and participants: Pre-menopausal BRCA1/2 mutation carriers choosing between RRSO and salpingectomy with delayed oophorectomy in Family Cancer Clinics in the Netherlands. Main outcome measures: IPDAS quality criteria, relevance, usability, clarity. Results: The patient decision aid underwent four rounds of alpha testing and revisions. Finally, two paper decision aids were developed: one for BRCA1 and one for BRCA2. They both contained a general introduction, three chapters and a step-by-step plan containing a personal value clarification worksheet. During alpha testing, risk communication and information about premature menopause and hormone therapy were the most revised items. The patient decision aids fulfil 37 of 43 (86%) IPDAS criteria for content and development process. Discussion and conclusions: Both BRCA1/2 mutation carriers and professionals are willing to use or offer the developed patient decision aids for risk-reducing surgery. The patient decision aids have been found clear, balanced and comprehensible. Future testing among patients facing the decision should point out its effectiveness in improving decision making

Comparison of analog and digital patient decision aids for the treatment of depression: a scoping review

Introduction: Patient decision aids (PDAs) are important tools to empower patients and integrate their preferences and values in the decision-making process. Even though patients with mental health problems have a strong interest in being more involved in decision making about their treatment, research has mainly focused on PDAs for somatic conditions. In this scoping review, we focus on patients suffering from depression and the role of PDAs for this patient group. The review offers an overview of digital and analog PDAs, their advantages and disadvantages as well as recommendations for further research and development. Methods: A systematic search of the existing literature guided by the Cochrane Handbook for Systematic Reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - extension for scoping reviews (PRISMA-ScR) was conducted. Three electronic literature databases with the appropriate thematic focus were searched (PubMed, PsycInfo, and Web of Science). The search strategy used controlled and natural language to search for the key concepts decision aids and depression. The articles were selected in a two-step process guided by predefined inclusion and exclusion criteria. We narratively synthetized information extracted from 40 research articles. Results: We included 40 articles in our review. Our review revealed that there is more focus on digital PDAs in research than in clinical practice. Digitalization can enhance the benefits of PDAs by developing tools that are more efficient, interactive, and personalized. The main disadvantages of both types of PDAs for the treatment of depression are related to time, dissemination, and capacity building for the health care providers. Digital PDAs need to be regularly updated, effective strategies for their dissemination and acceptance need to be identified, and clinicians need sufficient training on how to use digital PDAs. There is more research needed to study which forms of PDAs are most appropriate for various patient groups (e.g., older adults, or patients with comorbidities), and to identify the most effective ways of PDAs' integration in the clinical workflow. The findings from our review could be well aligned with the International Patient Decision Aids Standards. Discussion: More research is needed regarding effective strategies for the implementation of digital PDAs into the clinical workflow, ethical issues raised by the digital format, and opportunities of tailoring PDAs for diverse patient groups

A decision aid to support family carers of people living with dementia towards the end-of-life: Coproduction process, outcome and reflections

BACKGROUND: Family carers of people living with dementia often need support with making decisions about care. Many find end-of-life care decisions particularly difficult. The aim of this article is to present an evidence- and theoretical-based process for developing a decision aid to support family carers of people with dementia towards the end-of-life. METHODS: Following a systematic process, we developed a decision aid using coproduction methods and matrices to synthesize data from a systematic review and qualitative interviews with people living with dementia and family carers. Data were presented to coproduction workshops of people living with dementia, family carers, practitioners and professionals. Development was guided by the Ottawa Decision Support Framework and a modified Interprofessional Shared Decision-Making model. RESULTS: The decision aid covers four decision areas: (1) changes in care; (2) eating and drinking difficulties; (3) everyday well-being; and (4) healthcare, tests and medication. We present an interactive decision aid, using a variety of approaches including written text, Frequently Asked Questions, top tips and illustrative quotes from people living with dementia and family carers. CONCLUSION: This is the first decision aid that focusses on multiple decisions towards the end-of-life in dementia care. The process offers a template for others to develop decision aids or similar interventions, and how to include people living with dementia in coproduction. PATIENT OR PUBLIC CONTRIBUTION: Family carers provided feedback on data collection, data analysis and the decision aid, and one is a coauthor. People living with dementia and family carers were integral to the coproduction workshops

Processes for evidence summarization for patient decision aids: A Delphi consensus study

Abstract Background Patient decision aids (PDAs) should provide evidence‐based information so patients can make informed decisions. Yet, PDA developers do not have an agreed‐upon process to select, synthesize and present evidence in PDAs. Objective To reach the consensus on an evidence summarization process for PDAs. Design A two‐round modified Delphi survey. Setting and participants A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. Data collection We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. Analysis Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. Results Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). Conclusion A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high‐quality PDAs. Patient contribution A patient partner was part of the steering group and involved in the development of the Delphi survey

Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke

Objectives: Families in the neurologic ICU urgently request goals-of-care decision support and shared decision-making tools. We recently developed a goals-of-care decision aid for surrogates of critically ill traumatic brain injury patients using a systematic development process adherent to the International Patient Decision Aid Standards. To widen its applicability, we adapted this decision aid to critically ill patients with intracerebral hemorrhage and large hemispheric acute ischemic stroke. Design: Prospective observational study. Setting: Two academic neurologic ICUs. Subjects: Twenty family members of patients in the neurologic ICU were recruited from July 2018 to October 2018. Interventions: None. Measurements and Main Results: We reviewed the existing critically ill traumatic brain injury patients decision aid for content and changed: 1) the essential background information, 2) disease-specific terminology to hemorrhagic stroke and ischemic stroke , and 3) disease-specific prognosis tailored to individual patients. We conducted acceptability and usability testing using validated scales. All three decision aids contain information from validated, disease-specific outcome prediction models, as recommended by international decision aid standards, including careful emphasis on their uncertainty. We replaced the individualizable icon arrays graphically depicting probabilities of a traumatic brain injury patient\u27s prognosis with icon arrays visualizing intracerebral hemorrhage and hemispheric acute ischemic stroke prognostic probabilities using high-quality disease-specific data. We selected the Intracerebral Hemorrhage Score with validated 12-month outcomes, and for hemispheric acute ischemic stroke, the 12-month outcomes from landmark hemicraniectomy trials. Twenty family members participated in acceptability and usability testing (n = 11 for the intracerebral hemorrhage decision aid; n = 9 for the acute ischemic stroke decision aid). Median usage time was 22 minutes (interquartile range, 16-26 min). Usability was excellent (median System Usability Scale = 84/100 [interquartile range, 61-93; with \u3e 68 indicating good usability]); 89% of participants graded the decision aid content as good or excellent, and greater than or equal to 90% rated it favorably for information amount, balance, and comprehensibility. Conclusions: We successfully adapted goals-of-care decision aids for use in surrogates of critically ill patients with intracerebral hemorrhage and hemispheric acute ischemic stroke and found excellent usability and acceptability. A feasibility trial using these decision aids is currently ongoing to further validate their acceptability and test their feasibility for use in busy neurologic ICUs

Enhancing treatment decision-making in bipolar II disorder: Development and evaluation of a treatment decision-aid for patients and their families

Background/Aims. A diagnosis of bipolar II disorder (BPII) is commonly accompanied by a need to make complex treatment decisions. As most research on treatment efficacy relates to bipolar I disorder, BPII treatment decisions have less evidence to support available treatment options and are more finely balanced in terms of benefits and side-effects. Yet, there is currently no resource to support patients with BPII (and their families) to make informed, preference-based treatment decisions. Patient decision-aids (DAs) are interventions designed to facilitate this process. This thesis aimed to develop and evaluate the first known DA for patients considering BPII treatment options. Methods. The thesis comprised four phases: i) a systematic literature review (Chapter 2); ii) qualitative interviews with patients with BPII (n=28), their families (n=13), and clinicians (n=20) (Chapters 3 – 5); iii) development of a DA according to International Patient Decision-Aid Standards (Chapter 6); iv) pilot of the DA to obtain evidence on its acceptability, feasibility, safety, and potential usefulness within a sample of potential end-users (30 patients with BPII, and 10 families; Chapter 7). Results. Phases i) and ii) identified key informational and decision-support priorities for patients with BPII and their families, as well as clinician-endorsed strategies for addressing barriers to treatment decision-making. These priorities and strategies then informed the content, format and delivery of the DA. Pilot data indicated that potential end-users strongly endorsed the DA, and provided preliminary evidence to support DA-related improvements in treatment decision-making. Conclusion. This innovative and comprehensive program of research culminated in the development and evaluation of a world-first DA for patients deciding on BPII treatment. The final DA has the potential to facilitate informed treatment decisions, which are both evidence-based and consistent with patient preferences

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist

Background: Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods, and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. Methods: An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases (1) Planning, (2) Drafting, and (3) Consensus, which included a modified, two stage, online international Delphi process. The work was conducted over two years with bi-monthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. Results: The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. Conclusion: The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent, and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the Checklist

Developing a decision aid to guide public sector health policy decisions: A study protocol

<p>Abstract</p> <p>Background</p> <p>Decision aids have been developed in a number of health disciplines to support evidence-informed decision making, including patient decision aids and clinical practice guidelines. However, policy contexts differ from clinical contexts in terms of complexity and uncertainty, requiring different approaches for identifying, interpreting, and applying many different types of evidence to support decisions. With few studies in the literature offering decision guidance specifically to health policymakers, the present study aims to facilitate the structured and systematic incorporation of research evidence and, where there is currently very little guidance, values and other non-research-based evidence, into the policy making process. The resulting decision aid is intended to help public sector health policy decision makers who are tasked with making evidence-informed decisions on behalf of populations. The intent is not to develop a decision aid that will yield uniform recommendations across jurisdictions, but rather to facilitate more transparent policy decisions that reflect a balanced consideration of all relevant factors.</p> <p>Methods/design</p> <p>The study comprises three phases: a modified meta-narrative review, the use of focus groups, and the application of a Delphi method. The modified meta-narrative review will inform the initial development of the decision aid by identifying as many policy decision factors as possible and other features of methodological guidance deemed to be desirable in the literatures of all relevant disciplines. The first of two focus groups will then seek to marry these findings with focus group members' own experience and expertise in public sector population-based health policy making and screening decisions. The second focus group will examine issues surrounding the application of the decision aid and act as a sounding board for initial feedback and refinement of the draft decision aid. Finally, the Delphi method will be used to further inform and refine the decision aid with a larger audience of potential end-users.</p> <p>Discussion</p> <p>The product of this research will be a working version of a decision aid to support policy makers in population-based health policy decisions. The decision aid will address the need for more structured and systematic ways of incorporating various evidentiary sources where applicable.</p

Determining information for inclusion in a decision-support intervention for clinical trial participation : A modified Delphi approach

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