Development Of Patient Decision Aid Research Articles

Exploring the burden of actinic keratoses through development of a patient decision aid: a mixed methods study.

Actinic keratoses (AKs) present on sun-exposed sites and are considered precursors of cutaneous squamous cell carcinoma (cSCC). A better understanding of the experiences of patients with this condition may improve patient-provider relationships and guide the introduction of shared-decision making (SDM) to treatment decisions. To develop a patient decision aid (PDA) for field treatment of multiple actinic keratoses in line with the International Patient Decision Aid Standards (IPDAS), by (i) characterising the burden and lived experiences of patients with multiple AKs, (ii) understanding the decisional needs of patients requiring field treatment and (iii) exploring clinician preferences regarding field treatment for multiple AKs. This mixed methods study followed the most up-to-date guidelines set out by the IPDAS Collaboration; a voluntary body which aims to enhance the quality of PDAs by developing an evidence-based systematic process for the development of unbiased and effective PDAs. Multiple actinic keratoses have a psychosocial impact on patients. Patients feel supported through the integration of evidence-based information to guide SDM. We propose that the use of a PDA for multiple AKs provides a key role in supporting informed shared patient-provider decision making and empowers patient involvement in their prospective treatment strategy.

Development and alpha testing of a patient shared decision aid for prosthesis design for new lower limb prosthesis users.

After lower limb amputation, several prosthesis design options exist. However, prosthesis design decisions do not always reflect a prosthesis user's needs, values, and preferences. To develop a patient decision aid (PDA) prototype for prosthetists and new prosthesis users facing prosthesis design decisions after lower limb amputation, and to assess its usability, accuracy, and comprehensibility. Exploratory mixed methods. PDA development was informed by a qualitative needs assessment and guided by the International Patient Decision Aid Standards. The PDA was evaluated by steering groups of experienced prosthesis users and prosthetic professionals (prosthetists and researchers) to test usability, accuracy, and comprehensibility through focus groups, individual interviews, and rating on a Likert scale ranging from 1 to 10. The resulting PDA included 6 sections: (1) Amputation and Early Recovery, (2) Communication, (3) Values, (4) Prosthesis Design, (5) Preferences, and (6) Prosthetic Journey. Usability, accuracy, and comprehensibility were rated as 9.2, 9.6, and 9.6, respectively, by prosthetic professionals, and 9.4, 9.6, and 9.6, respectively, by prosthesis users. The PDA incorporated guidance by relevant stakeholders and was rated favorably, emphasizing a need for shared decision-making support in prosthesis design. One challenge was determining the amount of information in the PDA, highlighting the diversity in end users' informational needs. Future iterations of the PDA should undergo beta testing in clinical settings. A standardized, iterative method was used to develop a PDA for new lower limb prosthesis users and prosthetists when considering prosthesis design decisions. The PDA was considered useable, accurate, and comprehensible.

Why to test for dementia: perspectives of patients, significant others and general practitioners.

This study aims to provide greater insight into the current decision-making process on diagnostic testing for dementia by exploring the expectations, needs and experiences of patients with memory complaints, significant others and general practitioners (GPs). We performed semi-structured interviews with patients (>60years) who consulted their GP on memory complaints, significant others and GPs. Participants were recruited until data saturation was reached in thematic analysis of interview transcripts. We performed 51 interviews (patients n = 20, significant others n = 15, GPs n = 16). Thematic analysis revealed four themes: (i) 'drivers to (not) testing', i.e. need to act on symptoms, beliefs on the necessity and expected outcomes of diagnostic testing; (ii) 'patient preferences and context are critical in the actual decision', i.e. in the actual decision-making process interpretation of symptoms, GPs' desire to meet patient preferences, social context and healthcare system dynamics guided the decision; (iii) 'need for individualised communication in the decision-making process', i.e. for patients feeling heard was a prerequisite for decision-making and GPs tailored communication strategies to individual patients and (iv) 'GP practice and barriers to shared decision-making (SDM)', i.e. although GPs value SDM in the decision on diagnostic testing for dementia, patients express limited awareness of the decision and options at stake. Decision-making on diagnostic testing for dementia is a multifactorial and preference-guided process for all involved stakeholders, but decisions are often not explicitly jointly made. Development of patient decision aids could facilitate better involvement and more informed choices by patients.

Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre–post trial

ObjectivesTo evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM).DesignPre–post study.SettingUniversity Hospital Schleswig-Holstein (UKSH), Kiel Campus.ParticipantsHealthcare...

Abstract P1-08-10: A web-based Patient Decision Aid Toolkit for unaffected BRCA mutation carriers

Abstract Women with a pathogenic mutation in the BRCA1 or BRCA2 genes have an elevated lifetime risk of developing breast and ovarian cancer. To address this risk, women are managed with a combination of surveillance and/or risk-reduction strategies. Decisions about risk management strategies can be complex, personal and multifactorial. Women often struggle with the decision-making process. In addition, within the clinical environment, there may be variations in recommendations between clinicians that can leave women uncertain and less able to choose a risk management pathway. The overall aim of this project is the development of a web-based patient decision aid toolkit for BRCA mutation carriers that will improve the decision-making process by providing the user with information about their cancer risk, options for risk management and potential benefits and side effects. Development of the patient decision aid was guided by the International Patient Decision Aid Standards (IPDAS). With appropriate ethical approval, a mixed methods approach was used to identify suitable content for the decision aid. A decision-making needs assessment was conducted to identify the information needs of women with a BRCA mutation. Semi-structured interviews were held with cancer unaffected BRCA mutation carriers (n = 16) and key stakeholders including healthcare professionals, policy makers and patient group representatives (n= 10). Data were analysed by thematic analysis. Systematic scoping reviews were conducted to synthesise relevant evidence on risk-management options, benefits, harms and the development and testing of patient decision aids in general. Content for the decision aid was refined using a Delphi process to build consensus on items for inclusion in the decision aid amongst a diverse panel of experts (n=13). A prototype patient decision aid was developed which included written information as well as visual depictions of risk, videos and photographs to enhance the patient’s information experience. A ‘values clarification’ activity was included to enable women to work through their own values and preferences relating to risk management interventions and their associated benefits and side-effects. Initial ‘sandpit’ testing of the decision aid prototype was performed by the research team and advisory group. Usability testing was conducted with BRCA mutation carries (n = 8) and healthcare professionals (n = 8) using both qualitative interviews and quantitative surveys. The research team made final revisions to the decision aid based on participant feedback and committee consensus. This evidence-based patient decision aid can be used by BRCA mutation carriers unaccompanied or during a clinical consultation. We envisage that this decision aid will improve the decision-making process by assisting women and clinicians during shared decision-making regarding cancer risk management. Citation Format: Sarah A. McGarrigle, Carol Spillane, Niamh Byrne, Manria Polus, Geraldine Prizeman, Amanda Drury, Elizabeth Connolly, Anne-Marie Brady, Yvonne Hanhauser. A web-based Patient Decision Aid Toolkit for unaffected BRCA mutation carriers [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-08-10.

"SDM:HOSP"- a generic model for hospital-based implementation of shared decision making.

Shared decision making (SDM) is a core element in the meeting between patient and healthcare professionals, but has proved difficult to implement and sustain in routine clinical practice. One of five Danish regions set out to succeed and to develop a model that ensures lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper describes this process and development of a generic implementation model, SDM:HOSP. This project was carried out in the Region of Southern Denmark with five major hospital units. Based on existing theory of SDM, SDM implementation, implementation science and improvement methodology, a process of four phases were described; development of conceptual elements, field-testing, evaluation, and development of the final implementation model. The conceptual elements developed aimed to prepare leaders, train SDM teachers, teach clinicians to perform SDM, support development of patient decision aids, and support systematic planning, execution and follow-up. Field testing was done including continuous participant evaluations and an overall evaluation after one year. Data from field testing and learnings from the implementation process, illustrated the need for a dynamic and easy adjustable model. The final SDM:HOSP model included four themes; i)Training of Leaders, ii) Training of Teachers and Clinicians, iii) Decision Helper, and iv) 'Process', each with details in three levels, 1) shared elements, 2) recommendations, and 3) local adaption. A feasible and acceptable model for implementation of SDM across hospitals and departments that accounts for different organizations and cultures was developed. The overall design can easily be adapted to other organizations and can be adjusted to fit the specific organization and culture. The results from the ongoing and overall evaluation suggest promising avenues for future work in further testing and research of the usability of the model.

Development of patient decision aids for the treatment of lentigo maligna and low-risk basal cell carcinoma

To the Editor: As medicine shifts from the traditional doctor-patient relationship toward 1 that empowers patients, shared decision making becomes an effective communication framework for clinicians and patients to make health-related decisions. Patient decision aids (PDAs) foster informed treatment decisions through increasing patient awareness of risks versus benefits, creating realistic outcome expectations and encouraging the implementation of personal values in decision making.1 PDAs differ from typical health education materials, which consist of general information, by focusing more on options and outcomes.

Making 2022 the year of psychosocial care in the kidney care community

Journal of Kidney CareVol. 7, No. 1 EditorialMaking 2022 the year of psychosocial care in the kidney care communityPeter EllisPeter EllisEmail: E-mail Address: [email protected]Health and Social Care Consultant, Writer and EducatorSearch for more papers by this authorPeter EllisPublished Online:15 Feb 2022https://doi.org/10.12968/jokc.2022.7.1.4AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Ellis P. We live and we learn: saying goodbye to 2020. J Kidney Care. 2021; 6(1):4–5. https://doi.org/10.12968/jokc.2021.6.1.4 Link, Google ScholarEllis P. Empowering older patients choosing renal replacement therapy or conservative management. J Kidney Care. 2022; 7(1):XXX Google ScholarEllis P and Abbott J, Supervision, part four: group supervision. J Kidney Care. 2022; 7(1):XXX Google ScholarNewman E, Hynes M. Chronic kidney disease and coronary artery disease treatment. J Kidney Care. 2022; 7(1):XXX Google ScholarNicolai C, Holt A. Chronic kidney disease and coronary artery disease treatment. J Kidney Care. 2022; 7(1):XXX Google ScholarOzdemir S, Choong LHL, Gan SWS et al. Patient decision aid development for older adults with end-stage kidney disease in Singapore. Kidney Int Reports. 2021; 6: 2885–2896. https://doi.org/10.1016/j.ekir.2021.08.027. Google Scholar FiguresReferencesRelatedDetails 2 January 2022Volume 7Issue 1ISSN (print): 2397-9534ISSN (online): 2397-9542 Metrics History Published online 15 February 2022 Published in print 2 January 2022 Information© MA Healthcare LimitedPDF download

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.

Determinants of Knowledge-Sharing Intentions for Shared Decision-Making Platforms

ABSTRACT With patient decision aids (PDAs) to evaluate all available care options and weigh patients’ preferences against evidence-based medicine, medical personnel and patients can make health-related decisions together. However, little research has been conducted on the critical determinants of medical personnel’s intentions to share knowledge with one another within their organization to develop PDAs. This study has developed a socio-technical integrated model to explain medical personnel’s intentions to share knowledge for the development of PDAs. This study employed a field survey in Taiwan to collect data. 421 valid questionnaires were completed for the statistical analysis. The results indicate that social network, social trust, perceived usefulness, compatibility, result demonstrability, and image have positive effects on knowledge-sharing intentions. Social network has a positive influence on shared goals, and ease of use has a positive impact on perceived usefulness. These findings provide valuable insights for medical informatics practices in promoting shared medical decision making.

Informed Consent for Organ Transplantation in Older Adults: Are Patient Decision Aids the Solution for Successful Implementation of Shared Decision-Making in Transplant Clinical Practice?

"Informed consent (IC) in older adults (≥ 70 years of age) is often complex. This holds even truer in the setting of organ transplantation (OTx), requiring patients to be informed of the risks and benefits associated with multiple options: whether or not to pursue a transplant, to opt for a living – where appropriate – or deceased donor, to consider a variety of choices concerning the potential for poorer organ quality or increased risk of disease transmission and others. IC overlaps with shared decision-making (SDM) in the presence of high-risk procedures, with low levels of certainty, and when two or more treatment alternatives exist. Patient decision aids (PDAs) (i.e. paper-based/electronic evidence-based tools) have been developed to complement and enhance SDM in clinical practice. Studies have proven PDAs to be an effective means to improve transplant knowledge, to foster patient participation, and to diminish decisional conflict across different settings in OTx. However, research is lacking on the effectiveness and appropriateness of these tools in older adults, which are increasingly entitled to receive OTx. The objective of our work is 1) to present the challenges posed by the use of PDAs in this group of patients and 2) to identify gaps so as to inform the agenda for research on this emergent issue. Our findings suggest that future studies should aim to the development, implementation and evaluation of PDAs for the oldest, more vulnerable segments of this specific patient population. "

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.

Developing a decision aid for youth with brachial plexus birth injuries facing treatment decisions for an elbow flexion contracture.

A common sequela of brachial plexus birth injury (BPBI) is an elbow flexion contracture. Youth with BPBI and their families face rehabilitation or surgical decisions that ideally entail careful deliberation of the risks and benefits of treatment within the context of the child's and family's functional and appearance-related goals. To develop a patient decision aid (PtDA) following International Patient Decision Aid Standards to help these youth and their families make treatment decisions. Mixed-methods study. Brachial plexus clinic in a pediatric tertiary care center. Five young adults (21-24 years), 14 youth (8-19 years) and their parents, 15 families (children 2-16 years), and 19 clinicians from a brachial plexus clinic participated in the PtDA development. Seventeen other youth (8-18 years) facing treatment decisions regarding their elbow contracture field tested the PtDA prototype. Not applicable. In-depth interviews and participant observation to conduct a decisional needs assessment of young adults, youth, parents, and health care professionals involved in these shared decisions. Cognitive interviews to field test the PtDA prototype. Evidence from previously conducted knowledge synthesis and the youth-focused decisional needs assessment qualitative data informed the development of new PtDA prototype, which included a questionnaire-based values clarification method for youth to rate what matters most to them regarding their elbow function, appearance, psychosocial impact, and treatment options. The majority (90%) of youth >11 years who field tested the PtDA prototype understood its content, whereas only 29% of those between 8 and 11 years demonstrated independent comprehension. The majority (69%) responded that they would prefer to use the PtDA on their own either at home or in the clinic waiting room. This new PtDA can be used to help youth with BPBI and their families to make a personal value-based informed decision regarding treatment options for their elbow flexion contracture.

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.

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].

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

BackgroundPatient 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.ObjectiveTo reach the consensus on an evidence summarization process for PDAs.DesignA two‐round modified Delphi survey.Setting and participantsA group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys.Data collectionWe 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.AnalysisCriteria 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.ResultsFollowing 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).ConclusionA multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high‐quality PDAs.Patient contributionA patient partner was part of the steering group and involved in the development of the Delphi survey.

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.

User Involvement in the Design and Development of Patient Decision Aids and Other Personal Health Tools: A Systematic Review.

When designing and developing patient decision aids, guidelines recommend involving patients and stakeholders. There are myriad ways to do this. We aimed to describe how such involvement occurs by synthesizing reports of patient decision aid design and development within a user-centered design framework and to provide context by synthesizing reports of user-centered design applied to other personal health tools. We included articles describing at least one development step of 1) a patient decision aid, 2) user- or human-centered design of another personal health tool, or 3) evaluation of these. We organized data within a user-centered design framework comprising 3 elements in iterative cycles: understanding users, developing/refining prototype, and observing users. We included 607 articles describing 325 patient decision aid projects and 65 other personal health tool projects. Fifty percent of patient decision aid projects reported involving users in at least 1 step for understanding users, 35% in at least 1 step for developing/refining the prototype, and 84% in at least 1 step for observing users' interaction with the prototype. In comparison, other personal health tool projects reported 91%, 49%, and 92%, respectively. A total of 74% of patient decision aid projects and 92% of other personal health tool projects reported iterative processes, both with a median of 3 iterative cycles. Preliminary evaluations such as usability or feasibility testing were reported in 66% of patient decision aid projects and 89% of other personal health tool projects. By synthesizing design and development practices, we offer evidence-based portraits of user involvement. Those wishing to further align patient decision aid design and development with user-centered design methods could involve users earlier, design and develop iteratively, and report processes in greater detail.

Developing and evaluating a patient decision aid for hormone therapy to manage symptoms of surgical menopause: the story behind the "SheEmpowers" patient decision aid.

To develop and evaluate an evidence-based patient decision aid (PDA) that can support women making decisions on hormone therapy (HT) for the management of early surgical menopause. The PDA development was guided by the Ottawa Decision Support Framework and the International Patient Decision Aid Standards and involved three phases: an exploratory phase to identify women's decisional needs; a development phase to identify evidence related to treatment options and draft initial prototype; and an evaluation phase to evaluate the prototype and elicit views on acceptability in women (N = 12). All phases were driven by a multidisciplinary group of researchers, clinicians, and patient stakeholders to ensure women's priorities were met. A prototype PDA was drafted based on needs identified from the exploratory phase. The PDA has five domains: information on surgical menopause and HT; HT outcome probabilities; patient stories; values clarification; and guidance in deliberation. Participants in the evaluation phase perceived the tool as acceptable and offered suggestions for modifications. Through our adopted, systematic approach the SheEmpowers PDA was developed to help women overcome deterrents to decision-making related to lack of knowledge, decision-making skills, and involvement in therapy decisions. The decisional effectiveness of the tool is to be assessed in future studies.

20th Anniversary Update of the Ottawa Decision Support Framework Part 1: A Systematic Review of the Decisional Needs of People Making Health or Social Decisions

Background. The Ottawa Decision Support Framework (ODSF) has been used for 20 years to assess and address people's decisional needs. The evidence regarding ODSF decisional needs has not been synthesized. Objectives. To synthesize evidence from ODSF-based decisional needs studies, identify new decisional needs, and validate current ODSF decisional needs. Methods. A mixed-studies systematic review. Nine electronic databases were searched. Inclusion criteria: studies of people's decisional needs when making health or social decisions for themselves, a child, or a mentally incapable person, as reported by themselves, families, or practitioners. Two independent authors screened eligibility, extracted data, and quality appraised studies using the Mixed Methods Appraisal Tool. Data were analyzed using narrative synthesis. Results. Of 4532 citations, 45 studies from 7 countries were eligible. People's needs for 101 unique decisions (85 health, 16 social) were reported by 2857 patient decision makers (n = 36 studies), 92 parent decision makers (n = 6), 81 family members (n = 5), and 523 practitioners (n = 21). Current ODSF decisional needs were reported in 2 to 40 studies. For 6 decisional needs, there were 11 new (manifestations): 1) information (overload, inadequacy regarding others' experiences with options), 2) difficult decisional roles (practitioner, family involvement, or deliberations), 3) unrealistic expectations (difficulty believing outcome probabilities apply to them), 4) personal needs (religion/spirituality), 5) difficult decision timing (unpredictable), and 6) unreceptive decisional stage (difficulty accepting condition/need for treatment, powerful emotions limiting information processing, lacking motivation to consider delayed/unpredictable decisions). Limitations. Possible publication bias (only peer-reviewed journals included). Possible missed needs (non-ODSF studies, patient decision aid development studies, 3 ODSF needs added in 2006). Conclusion. We validated current decisional needs, identified 11 new manifestations of 6 decisional needs, and recommended ODSF revisions.