Development Of Decision Aid Research Articles

100: Engaging stakeholders in the development of a reproductive goals decision aid for women with cystic fibrosis

100: Engaging stakeholders in the development of a reproductive goals decision aid for women with cystic fibrosis

Towards a mass customization in the fashion industry: An evolutionary decision aid model for apparel product platform design and optimization

To meet the diverse needs of customers with a competitive offering, many companies are utilizing product families and platform-based product development to increase variety, shorten lead times and reduce costs. However, current research in this area does not sufficiently examine broader enterprise considerations, such as production and inventory management complexity and costs, or expected sales. Furthermore, very few existing platform design methods integrate fitting and ergonomic considerations in their formulation.This study proposes a two-stage platform-based design process to support apparel brands to implement mass customization (MC) strategies. This work has been conducted in collaboration with Yamamay, an Italian underwear and lingerie brand. In the first stage, the characteristics of a scale-based platform (i.e. the number of product variants) are determined based on (i) the results of the anthropometric analysis of a large Italian female population sample, (ii) business considerations discussed together with brand managers and experts, (iii) and benchmarking data. In the second stage, a novel and ad-hoc developed evolutionary-based decision aid model stretches and shrinks the resulting classes looking for the optimal trade-off based on anthropometric data between the demand of garments that fit well and the percentage of the population that is satisfied with the proposed product family.The approach proposed here has been proved effective not only in theory but also in practice through a pilot launch of a test product family. Integrating scale-based platform design of apparel with ergonomic, production, inventory, and sales considerations makes this study unique and paves the way for the implementation of customization-as-a-service business model and for the transformation of the fashion industry into a technology- and knowledge-intensive industry.

"Lock and Protect": Development of a Digital Decision Aid to Support Lethal Means Counseling in Parents of Suicidal Youth.

Objective: Reducing access to lethal methods is an effective suicide prevention strategy that is often neglected in routine care. Digital interventions have shown promise for addressing such gaps in care; and decision aids have proven useful for supporting complicated health-related decisions, like those involving lethal means restriction. This article describes a parent/caregiver-facing web-based decision aid, the development process, and user testing.Method: A user-centered, participatory, mixed methods development design was employed. Beginning with an adult-focused decision aid developed by members of our team, we assessed ten iterations of the parent/caregiver decision aid with stakeholders (N = 85) using qualitative interviews and quantitative surveys. Stakeholders included: parents/caregivers whose children had histories of suicidal episodes before age 25, young adults with histories of suicidal thoughts/behaviors, firearm owners/representatives from firearm stores/ranges/groups, mental and medical health care providers, and emergency responders.Results: The final “Lock and Protect” decision aid was viewed as “useful for changing access to lethal means” by 100% of participants. Ninety-four percent of participants rated the information on reducing access to lethal means as good to excellent, and 91% rated the information on storage options as good to excellent. Qualitative feedback underscored a preference for offering this digital tool with a “human touch,” as part of safety and discharge planning.Conclusions: “Lock and Protect” is a user-friendly web-based tool with potential for improving rates of lethal means counseling for parents/caregivers of suicidal youth and ultimately reducing pre-mature deaths by suicide.

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, and CINAHL.Study SelectionWe 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 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-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).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.

Patient Decision Aid Development for Older Adults With End-Stage Kidney Disease in Singapore

IntroductionIn managing end-stage kidney disease (ESKD), older adults face a decision regarding whether to undergo dialysis or manage symptoms through kidney supportive care (KSC). This article describes the development of a patient decision aid (PDA) that is designed specifically for older adults with ESKD.MethodsThe decision context of the PDA was to choose a treatment between hemodialysis, peritoneal dialysis, and KSC. The development process used insights obtained from qualitative interviews with patients, informal caregivers, and health care providers. The PDA was then developed in English and Mandarin and was pilot-tested with patients, caregivers, and health care providers. We finalized the PDA based on feedback from pilot testing and performed a preliminary evaluation based on the International Patient Decision Aid Standards (IPDASi v4.0) criteria.ResultsThe final PDA consists of 2 booklets and a video. During pilot testing, patients and caregivers reported high levels of ease of understanding and usefulness with ≥92.5% providing agree/strongly agree responses for the “Content”-related criteria, and ≥75% providing agree/strongly agree responses for the “Development Process and Effectiveness”–related criteria. The final PDA met 10 of 12 IPDASi v4.0 criteria.ConclusionsThis PDA was found useful during pilot-testing. It will be used during renal counseling in Singapore to help older adults with ESKD and their caregivers make informed decisions on which treatment option is best for the patients.

Using Mixed Methods with Multiple Stakeholders to Inform Development of a Breast Cancer Screening Decision Aid for Women with Limited Health Literacy

Research ObjectiveLittle is known about the best process for selecting content for decision aids (DAs) on mammography screening. This analysis triangulates perspectives (experts, primary care providers, and patients) to understand areas of divergent and convergent input across stakeholder groups in developing a breast cancer screening DA for women ages 40–54 with limited health literacy.Study DesignA 3‐round modified Delphi panel was conducted among national breast cancer screening and decision science experts. They rated the importance of 57 statements for possible inclusion in a breast cancer screening DA. Qualitative comments about each statement were collected via open‐ended text fields. Analysis was conducted following the RAND Appropriateness methodology. Separately, 25 women with limited health literacy (patients) and 20 primary care providers (PCPs) from outpatient clinics at a Boston‐based safety net hospital completed interviews exploring mammography‐related informational needs. To identify areas where stakeholder perspectives converged or diverged from each other, we conducted a qualitative synthesis using a constant comparison technique. Codes were developed and compared: (1) at the level of the individual interview; (2) within stakeholder groups; and, (3) across stakeholder groups.Population StudiedEight experts participated in the Delphi panel. Participants had an advanced degree (MD, PhD), &gt; 3 years of either professional, clinical or research experience, and content expertise in breast cancer screening, health literacy, or DA design. Patients included mammography‐eligible, primary care patients ages 40–54 with upcoming visits, and limited health literacy as defined by a score of &lt;7 on the Health Literacy Skills Instrument‐10. PCPs included physicians and nurse practitioners in family medicine or general internal medicine clinics.Principal FindingsIn the multi‐stakeholder synthesis, four themes regarding informational needs were identified related to: (a) the benefits and harms of screening, (b) different screening modalities, (c) the experience of mammography, and (d) communication about breast cancer risk. Convergence occurred around personal risk information, with all stakeholders describing it as important. Divergence occurred within the other three themes. Patients viewed pain as the primary harm, while PCPs and experts emphasized false positives as the primary harm. Process information about the mammography experience was critical to patient decisions; Experts and PCPs described process as less relevant. Patients valued breast self‐exam information, while PCPs and experts did not since self‐exams have been shown to be ineffective.ConclusionsWhile experts and PCPs prioritized providing evidence‐based options only, emphasized technology‐related harms, and downplayed the relevance of delivering mammography process information, patients were more concerned about pain, breast self‐exam (which is not supported by evidence), and viewed process information as fundamental to their decision‐making. These differences indicate opportunities to address patient‐identified unmet informational needs in breast cancer screening DAs.Implications for Policy or PracticeEvidence and guidance to advance best practices in integrating diverse and potentially divergent input across groups in DAs is warranted. Greater integration of patient voices, especially of those who are underserved, requires additional efforts to address patients' informational needs, which may differ from expert‐ and PCP‐defined priorities.Primary Funding SourceNational Institutes of Health.

Factors influencing the degree of participation in surgical decision-making among Chinese patients with prostate cancer: A qualitative research

ObjectiveThere was increasingly demand of participation in surgical decision-making among Chinese patients with prostate cancer. However, due to the complex healthcare system and advanced care settings, it is quite challenging for the patients to gain sufficient support from the institute and the government. This research aimed to investigate the factors that impact the degree of participation in surgical decision-making among Chinese prostate cancer patients. MethodsA phenomenological approach of qualitative research based on the results of semi-structured interviews was adopted, to explore the influencing factors which hinder the participation in surgical decision-making. Consolidated Criteria for Reporting Qualitative Research were utilized. Up to 160 post-operative patients who had undergone radical prostatectomy along with 68 medical and nursing staffs, were purposively recruited in this research. This retrospective study was carried out from September 2018 to August 2019. After recording and transcribing the interviews, the interview materials were evaluated via the Colaizzi's seven step approach and the NVivo Version 10 software to analyze the interview content. ResultsAccording to the analysis and summary of the interviews, there were three factors affecting the degree of participation in surgical decision-making. Firstly, insufficient information was provided by medical and nursing staffs because of their lack of time, proper communication skills, and career experience, as well as difficulties in the development of patient decision aid and inconsistent resource availability. Secondly, the cognitive level of decision-making among patients was relatively low due to poor psychological endurance, insufficient amount of education, senility, and less knowledge and information demand. Ultimately, decisions were constantly made by family members with/without patients. ConclusionsThe degree of participation of Chinese prostate cancer patients in the surgical decision-making had much space for improvement.

Development of a patient decision aid on subacromial decompression surgery and rotator cuff repair surgery: an international mixed-methods study

ObjectiveTo develop and user test a patient decision aid for people with subacromial pain syndrome that presents evidence-based information on the benefits and harms of subacromial decompression surgery and rotator...

Implementation of shared decision-making for aortic stenosis: Development of a patient decision aid

Abstract Funding Acknowledgements Type of funding sources: None. Background People living with aortic stenosis (AS) experience poor quality of life (QOL), repeat hospitalizations, and a poor prognosis in the absence of valve replacement. There is increasing equipoise in the evidence supporting the use of surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) in patients likely to derive survival and QOL benefit. A transition to a palliative approach may be a better option in the setting of excessive frailty and comorbid burden. Shared decision-making (SDM) is a bidirectional exchange between patients and health care providers that enables an information exchange about the best available evidence and decisions that consider patients" priorities. The goal is to inform and empower patients to participate in choosing the right decision. Patient decision aids (PDAs) are designed to support the process of SDM and help guide these conversation. To date, Canadians living with AS have not had access to a validated PDA. Study Design We will report on the design of the SharEd DEcision-MaKing for AS (SEEK-AS) study that aims to refine and comprehensively evaluate a set of PDAs and to build capacity for SDM through a unique partnership of patient and clinical knowledge users, multidisciplinary health care providers and researchers, and policy-makers. We will summarize the pilot work completed to obtain a debrief of patient resources used in all Canadian provinces, the draft development of a PDA in concert with a health policy initiative, and the design of an electronic platform to individualize risk in real time during a consultation. We will outline the components of SEEK-AS and the use of a cross-provincial comparative case study design to investigate how to establish an effective and sustainable approach for the implementation of the PDAs using the Knowledge-to-Action conceptual framework. Implications There is a pressing need for the development of evidence-based tools to strengthen the integration of patients" perspectives in the treatment of complex valvular heart disease given the rapid pace of change in technology, indications and practice. The study of the implementation of innovative strategies to achieve this goal is essential to accelerate the pace of change in clinical care.

Development and field testing of a patient decision aid for management of acute Achilles tendon rupture: a study protocol

BackgroundAchilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures.MethodsThis is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes.DiscussionThis comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality.Trial registration Not Applicable.

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

BackgroundFamily 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.MethodsFollowing 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.ResultsThe 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.ConclusionThis 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 ContributionFamily 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.

Using Mixed Methods With Multiple Stakeholders to Inform Development of a Breast Cancer Screening Decision Aid for Women With Limited Health Literacy.

Background. When stakeholders offer divergent input, it can be unclear how to prioritize information for decision aids (DAs) on mammography screening. Objectives. This analysis triangulates perspectives (breast cancer screening experts, primary care providers [PCPs], and patients with limited health literacy [LHL]) to understand areas of divergent and convergent input across stakeholder groups in developing a breast cancer screening DA for younger women with LHL. Design. A modified online Delphi panel of 8 experts rated 57 statements for inclusion in a breast cancer screening DA over three rounds. Individual interviews with 25 patients with LHL and 20 PCPs from a large safety net hospital explored informational needs about mammography decision making. Codes from the qualitative interviews and open-ended responses from the Delphi process were mapped across stakeholders to ascertain areas where stakeholder preferences converged or diverged. Results. Four themes regarding informational needs were identified regarding 1) the benefits and harms of screening, 2) different screening modalities, 3) the experience of mammography, and 4) communication about breast cancer risk. Patients viewed pain as the primary harm, while PCPs and experts emphasized the harm of false positives. Patients, but not PCPs or experts, felt that information about the process of getting a mammogram was important. PCPs believed that mammography was the only evidence-based screening modality, while patients believed breast self-exam was also important for screening. All stakeholders described incorporating personal risk information as important. Limitations. As participants came from one hospital, perceptions may reflect local practices. The Delphi sample size was small. Conclusions. Patients, experts, and PCPs had divergent views on the most important information needed for screening decisions. More evidence is needed to guide integration of multiple stakeholder perspectives into the content of DAs. Article HighlightsThis study combines data from patients with limited health literacy, primary care providers (PCPs), and experts to examine priorities for information inclusion in a breast cancer screening decision aid.All stakeholders described including personal risk information as important.While experts and PCPs prioritized providing evidence-based screening options only, emphasized false positives as the primary mammography harm, and downplayed the relevance of delivering mammography process information, patients had a broader scope of harms (e.g., pain), wanted more information on breast self- exam, and viewed process information as fundamental to their decision making.This study demonstrates that there are differences in what doctors and experts prioritize communicating about breast cancer screening and what patients want to learn about.

Systematic Development of Patient Decision Aids: An Update from the IPDAS Collaboration.

The 2013 update of the evidence informing the quality dimensions behind the International Patient Decision Aid Standards (IPDAS) offered a model process for developers of patient decision aids. To summarize and update the evidence used to inform the systematic development of patient decision aids from the IPDAS Collaboration. To provide further details about design and development methods, we summarized findings from a subgroup (n = 283 patient decision aid projects) in a recent systematic review of user involvement by Vaisson et al. Using a new measure of user-centeredness (UCD-11), we then rated the degree of user-centeredness reported in 66 articles describing patient decision aid development and citing the 2013 IPDAS update on systematic development. We contacted the 66 articles' authors to request their self-reports of UCD-11 items. The 283 development processes varied substantially from minimal iteration cycles to more complex processes, with multiple iterations, needs assessments, and extensive involvement of end users. We summarized minimal, medium, and maximal processes from the data. Authors of 54 of 66 articles (82%) provided self-reported UCD-11 ratings. Self-reported scores were significantly higher than reviewer ratings (reviewers: mean [SD] = 6.45 [3.10]; authors: mean [SD] = 9.62 [1.16], P < 0.001). Decision aid developers have embraced principles of user-centered design in the development of patient decision aids while also underreporting aspects of user involvement in publications about their tools. Templates may reduce the need for extensive development, and new approaches for rapid development of aids have been proposed when a more detailed approach is not feasible. We provide empirically derived benchmark processes and a reporting checklist to support developers in more fully describing their development processes.[Box: see text].

Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

BackgroundFor patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design.MethodsPDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect.ResultsFive hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video.ConclusionThe low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.

Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making

BackgroundWomen with pathogenic BRCA1 and BRCA2 mutations possess a high risk of developing breast and ovarian cancer. They face difficult choices when considering preventive options. This study presents the development process of the first decision aids to support this complex decision-making process in the German healthcare system.MethodsA six-step development process based on the International Patient Decision Aid Standards was used, including a systematic literature review of existing decision aids, a topical medical literature review, preparation of the decision aids, focus group discussions with women with BRCA1/2 mutations, internal and external reviews by clinical and self-help experts, and user tests. All reviews were followed by iterative revisions.ResultsNo existing decision aids were transferable to the German setting. The medical research revealed a need to develop separate decision aids for women with BRCA1/2 mutations (A) without a history of cancer (previvors) and (B) with a history of unilateral breast cancer (survivors). The focus group discussions confirmed a high level of approval for the decision aids from both target groups. Additionally, previvors requested more information on risk-reducing breast surgery, risk-reducing removal of both ovaries and Fallopian tubes, and psychological aspects; survivors especially wanted more information on breast cancer on the affected side (e.g. biological parameters, treatment, and risk of recurrence).ConclusionsIn a structured process, two target-group-specific DAs for previvors/survivors with BRCA1/2 mutations were developed to support decision-making on risk-adapted preventive options. These patient-oriented tools offer an important addition to existing specialist medical care in Germany.

Addressing Health Literacy in Patient Decision Aids: An Update from the International Patient Decision Aid Standards.

There is increasing recognition of the importance of addressing health literacy in patient decision aid (PtDA) development. An updated review as part of IPDAS 2.0 examined the extent to which PtDAs are designed to meet the needs of people with low health literacy/socially-disadvantaged populations. Reference lists of Cochrane reviews of randomized controlled trials (RCTs) of PtDAs (2014, 2017, and upcoming 2021 versions). RCTs that assessed the impact of PtDAs on low health literacy or other socially-disadvantaged groups (i.e., ≥50% participants from socially-disadvantaged groups and/or subgroup analysis in socially-disadvantaged group/s). Two researchers independently extracted data into a standardized form including PtDA development and evaluation details. We searched online repositories and emailed authors to access PtDAs to verify grade reading level, understandability, and actionability. Twenty-five of 213 RCTs met the inclusion criteria, illustrating that only 12% of studies addressed the needs of low health literacy or other socially-disadvantaged groups. Grade reading level was calculated in 8 of 25 studies (33%), which is recommended in previous IPDAS guidelines. We accessed and independently assessed 11 PtDAs. None were written at sixth-grade level or below. Ten PtDAs met the recommended threshold for understandability, but only 5 met the recommended threshold for actionability. We also conducted a post hoc subgroup meta-analysis and found that knowledge improvements after receiving a PtDA were greater in studies that reported using strategies to reduce cognitive demand in PtDA development compared with studies that did not (χ2 = 14.11, P = 0.0002, I2 = 92.9%). We were unable to access 13 of 24 PtDAs. Conclusions. Greater attention to health literacy and socially-disadvantaged populations is needed in the field of PtDAs to ensure equity in decision support.

Shared Decision-Making and Information Needs among People with Generalized Anxiety Disorder.

Shared decision making (SDM) aims to involve patients in the decisions about their care, considering their preferences, values and concerns about the different treatment options. However, research shows that people with mental health problems have considerable unmet information needs about their condition. This community-based cross-sectional study explores the SDM process and information needs among people with Generalized Anxiety Disorder (GAD), as an initial step in the design and development of a Patient Decision Aid for this population. Seventy participants completed an online survey with the Control Preference Scale, and questions about the perceived difficulty of past treatment decisions and the use of the Internet for searching for GAD-related information. Most participants preferred an active (42.9%) or collaborative role (41.4%) in the SDM process, and 53% did not perceive their preferred role. Information provided by healthcare professionals was considered insufficient by 28% of the sample, and over 30% reported using the Internet to look for GAD-related information at least once a week or more. The most relevant GAD-related information needs were general information (71.4%), information on self-help groups (65.7%), recommendations on how to face this disorder (61.4%) and information on treatment options (50%). Exploratory analyses showed that patients who perceived an active participation were more likely to search for information frequently (p = 0.038), and those who felt more involved than desired tended to search for more themes (p = 0.049). In summary, the study showed that a considerable percentage of GAD patients have unmet needs related to decision-making participation and information.

Development and user-testing of a brief decision aid for aspirin as a preventive approach alongside colorectal cancer screening

BackgroundSeveral epidemiological and cohort studies suggest that regular low-dose aspirin use independently reduces the long-term incidence and risk of colorectal cancer deaths by approximately 20%. However, there are also risks to aspirin use, mainly gastrointestinal bleeding and haemorrhagic stroke. Making informed decisions depends on the ability to understand and weigh up benefits and risks of available options. A decision aid to support people to consider aspirin therapy alongside participation in the NHS bowel cancer screening programme may have an additional impact on colorectal cancer prevention. This study aims to develop and user-test a brief decision aid about aspirin to enable informed decision-making for colorectal screening-eligible members of the public.MethodsWe undertook a qualitative study to develop an aspirin decision aid leaflet to support bowel screening responders in deciding whether to take aspirin to reduce their risk of colorectal cancer. The iterative development process involved two focus groups with public members aged 60–74 years (n = 14) and interviews with clinicians (n = 10). Interviews (n = 11) were used to evaluate its utility for decision-making. Analysis was conducted using a framework approach.ResultsOverall, participants found the decision aid acceptable and useful to facilitate decision-making. They expressed a need for individualised risk information, more detail about the potential risks of aspirin, and preferred risk information presented in pictograms when offered different options. Implementation pathways were discussed, including the possibility of involving different clinicians in the process such as GPs and/or community pharmacists. A range of potentially effective timepoints for sending out the decision aid were identified.ConclusionAn acceptable and usable decision aid was developed to support decisions about aspirin use to prevent colorectal cancer.

Development and Evaluation of a Prediabetes Decision Aid in Primary Care: Examining Patient-Reported Outcomes by Language Preference and Educational Attainment.

The purpose of this study was to examine the development and preliminary effectiveness of a novel Prediabetes Decision Aid on adoption of intensive lifestyle interventions (ILIs) and metformin. Little research has focused on increasing uptake of these evidence-based treatments, especially among non-English speakers and those with low educational attainment. Investigators developed an English and Spanish decision aid displaying information about type 2 diabetes (T2DM) risk and treatments to prevent T2DM and prompting patients to identify next steps for management. This pilot study was a single-arm, pretest-posttest trial of 40 adult patients with prediabetes, obesity, and ≥1 office visit within the prior 12 months. Participants reviewed this tool briefly with a study team member, and data were collected on 3 coprimary outcomes: knowledge about T2DM risk, decisional conflict, and intention to adopt treatment. Exploratory outcomes included subsequent documentation of prediabetes in chart notes and adoption of ILIs or metformin. Almost all participants were women, with nearly half expressing Spanish language preference and low educational attainment. A nonsignificant increase in knowledge was observed across all subgroups. Decisional conflict was significantly reduced from pretest to posttest and was similar between subgroups defined by language preference and educational attainment. While intention to adopt ILIs increased across all subgroups, this change was only significant among Spanish speakers and participants with low educational attainment. At 6 months, 17 participants had subsequent provider documentation of prediabetes, and 12 adopted ILIs or metformin. The decision aid improved patient-reported outcomes and promoted treatment adoption in a diverse patient sample.

Addressing Conflicts of Interest in Health and Medicine: Current Evidence and Implications for Patient Decision Aid Development.

More stringent policies for addressing conflicts of interest have been implemented around the world in recent years. Considering the value of revisiting conflict of interest quality standards set by the International Patient Decision Aid Standards (IPDAS) Collaboration, we sought to review evidence relevant to 2 questions: 1) What are the effects of different strategies for managing conflicts of interest? and 2) What are patients' perspectives on conflicts of interest? We conducted a narrative review of English-language articles and abstracts from 2010 to 2019 that reported relevant quantitative or qualitative research. Of 1743 articles and 118 abstracts identified, 41 articles and 2 abstracts were included. Most evidence on the effects of conflict of interest management strategies pertained only to subsequent compliance with the management strategy. This evidence highlighted substantial noncompliance with prevailing requirements. Evidence on patient perspectives on conflicts of interest offered several insights, including the existence of diverse views on the acceptability of conflicts of interest, the salience of conflict of interest type and monetary value to patients, and the possibility that conflict of interest disclosure could have unintended effects. We identified no published research on the effects of IPDAS Collaboration conflict of interest quality standards on patient decision making or outcomes. Because we did not conduct a systematic review, we may have missed some evidence relevant to our review questions. In addition, our team did not include patient partners. The findings of this review have implications for the management of conflicts of interest not only in patient decision aid development but also in clinical practice guideline development, health and medical research reporting, and health care delivery.