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BackgroundIn cancers with a chronic phase, patients and family caregivers face difficult decisions such as whether to start a novel therapy, whether to enroll in a clinical trial, and when to stop treatment. These decisions are complex, require an understanding of uncertainty, and necessitate the consideration of patients' informed preferences. For some cancers, such as medullary thyroid carcinoma, these decisions may also involve significant out-of-pocket costs and effects on family members. Providers have expressed a need for web-based interventions that can be delivered between consultations to provide education and prepare patients and families to discuss these decisions. To ensure that these tools are effective, usable, and understandable, studies are needed to identify patients', families', and providers' decision-making needs and optimal design strategies for a web-based patient decision aid.ObjectiveFollowing the international guidelines for the development of a web-based patient decision aid, the objectives of this study are to engage potential users to guide development; review the existing literature and available tools; assess users' decision-making experiences, needs, and design recommendations; and identify shared decision-making approaches to address each need.MethodsThis study used the decisional needs assessment approach, which included creating a stakeholder advisory panel, mapping decision pathways, conducting an environmental scan of existing materials, and administering a decisional needs assessment questionnaire. Thematic analyses identified current decision-making pathways, unmet decision-making needs, and decision support strategies for meeting each need.ResultsThe stakeholders reported wide heterogeneity in decision timing and pathways. Relevant existing materials included 2 systematic reviews, 9 additional papers, and multiple educational websites, but none of these met the criteria for a patient decision aid. Patients and family members (n=54) emphasized the need for plain language (46/54, 85%), shared decision making (45/54, 83%), and help with family discussions (39/54, 72%). Additional needs included information about uncertainty, lived experience, and costs. Providers (n=10) reported needing interventions that address misinformation (9/10, 90%), foster realistic expectations (9/10, 90%), and address mistrust in clinical trials (5/10, 50%). Additional needs included provider tools that support shared decision making. Both groups recommended designing a web-based patient decision aid that can be tailored to (64/64, 100%) and delivered on a hospital website (53/64, 83%), focuses on quality of life (45/64, 70%), and provides step-by-step guidance (43/64, 67%). The study team identified best practices to meet each need, which are presented in the proposed decision support design guide.ConclusionsPatients, families, and providers report multifaceted decision support needs during the chronic phase of cancer. Web-based patient decision aids that provide tailored support over time and explicitly address uncertainty, quality of life, realistic expectations, and effects on families are needed.

Abstract Background Coaching and guidance are structured approaches that can be used within or alongside patient decision aids (PtDAs) to facilitate the process of decision making. Coaching is provided by an individual, and guidance is embedded within the decision support materials. The purpose of this paper is to: a) present updated definitions of the concepts “coaching” and “guidance”; b) present an updated summary of current theoretical and empirical insights into the roles played by coaching/guidance in the context of PtDAs; and c) highlight emerging issues and research opportunities in this aspect of PtDA design. Methods We identified literature published since 2003 on shared decision making theoretical frameworks inclusive of coaching or guidance. We also conducted a sub-analysis of randomized controlled trials included in the 2011 Cochrane Collaboration Review of PtDAs with search results updated to December 2010. The sub-analysis was conducted on the characteristics of coaching and/or guidance included in any trial of PtDAs and trials that allowed the impact of coaching and/or guidance with PtDA to be compared to another intervention or usual care. Results Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients in the process of thinking about a decision and in communicating their values/preferences with others. In 98 randomized controlled trials of PtDAs, 11 trials (11.2%) included coaching and 63 trials (64.3%) provided guidance. Compared to usual care, coaching provided alongside a PtDA improved knowledge and decreased mean costs. The impact on some other outcomes (e.g., participation in decision making, satisfaction, option chosen) was more variable, with some trials showing positive effects and other trials reporting no differences. For values-choice agreement, decisional conflict, adherence, and anxiety there were no differences between groups. None of these outcomes were worse when patients were exposed to decision coaching alongside a PtDA. No trials evaluated the effect of guidance provided within PtDAs. Conclusions Theoretical evidence continues to justify the use of coaching and/or guidance to better support patients to participate in decision making. However, there are few randomized controlled trials that have compared the effectiveness of coaching used alongside PtDAs to PtDAs without coaching, and no trials have compared the PtDAs with guidance to those without guidance.

Patients' preferences regarding changing or maintaining their breast size after mastectomy and reconstruction are important but understudied determinants of post-surgical satisfaction and quality of life. The goal of this study was to identify factors associated with preferences for changing or maintaining breast size for women undergoing breast reconstruction at The University of Texas MD Anderson Cancer Center in the United States from 2011 to 2014. The average age of participants was 45.7 ± 9.1 years. At baseline, mean average breast volumes were 755.7 ± 328.4 mL for all women (n = 48), 492.3 mL ± 209.3 for 13 women who preferred to be "bigger than now," 799.2 mL ± 320.9 for 25 women who preferred to remain "about the same," and 989.3 mL ± 253.1 for 10 women who preferred "smaller than now." Among the 23 women who preferred to change their breast size, 19 desired to shift toward the mean. Women with the smallest and largest 20% of baseline breast size were more likely to desire a change toward the mean (p = 0.006). Multinomial logistic regression models found average breast volume and satisfaction with breast size to be the most important factors associated with preferences for changing or maintaining breast size for women undergoing breast reconstruction. This study provides preliminary evidence for a "Goldilocks principle" in women's preferences for breast size change in the context of breast reconstruction, and identifies hypotheses for future studies of the associations among preference for change in breast size, preference achievement, and post-reconstruction body image. [ABSTRACT FROM AUTHOR]

Background: 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. Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

This study assessed the needs and perspective of (1) couples and (2) spouses/partners when considering fertility preservation after a cancer diagnosis. Semi-structured interviews explored (1) couples' shared decision-making and (2) spouses'/partners' individual perspectives. Twelve female cancer survivors and their partners (spouses or domestic/romantic partners) (n = 24). Dyadic and individual interviews were conducted using a Decisional Needs Assessment interview guide. Thematic analysis identified key themes. Couples reported making fertility preservation decisions like other major decisions, including prioritizing mutual satisfaction. Partners also reported concerns about patients' health, variable decision-making needs, and letting patients lead. Couples unanimously recommended fertility preservation consultations, and designing resources that provide information and assess needs for both patients and partners. Patients and partners have shared and unique needs when facing fertility preservation decisions. Whenever feasible, psychosocial providers should assess and address couples' and partners' fertility preservation decision-making needs. [ABSTRACT FROM AUTHOR]

Background and Objectives Decisions about long-term care and financing can be difficult to comprehend, consider, and communicate. In a previous needs assessment, families in rural areas requested a patient-facing website; however, questions arose about the acceptability of an online tool for older adults. This study engaged older adults and family caregivers in (a) designing and refining an interactive, tailored decision aid website, and (b) field testing its utility, feasibility, and acceptability. Research Design and Methods Based on formative work, the research team engaged families in designing and iteratively revising paper drafts, then programmed a tailored website. The field test used the ThinkAloud approach and pre-/postquestionnaires to assess participants' knowledge, decisional conflict, usage, and acceptability ratings. Results Forty-five older adults, family members, and stakeholders codesigned and tested the decision aid, yielding four decision-making steps: Get the Facts , What Matters Most, Consider Your Resources, and Make an Action Plan. User-based design and iterative storyboarding enhanced the content, personal decision-making activities, and user-generated resources. Field-testing participants scored 83.3% correct on knowledge items and reported moderate/low decisional conflict. All (100%) were able to use the website, spent an average of 26.3 min, and provided an average 87.5% acceptability rating. Discussion and Implications A decision aid website can educate and support older adults and their family members in beginning a long-term care plan. Codesign and in-depth interviews improved usability, and lessons learned may guide the development of other aging decision aid websites. [ABSTRACT FROM AUTHOR]

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 2 years with bimonthly conference calls and three inperson 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 96/1 17 (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. [ABSTRACT FROM AUTHOR]

This Explanation and Elaboration (E&E) article expands on the 26 items in the Standards for UNiversal reporting of Decision Aid Evaluations guidelines. The E&E provides a rationale for each item and includes examples for how each item has been reported in published papers evaluating patient decision aids. The E&E focuses on items key to reporting studies evaluating patient decision aids and is intended to be illustrative rather than restrictive. Authors and reviewers may wish to use the E&E broadly to inform structuring of patient decision aid evaluation reports, or use it as a reference to obtain details about how to report individual checklist items. [ABSTRACT FROM AUTHOR]

Purpose: To improve survivors' awareness and knowledge of fertility preservation counseling and treatment options, this study engaged survivors and providers to design, develop, and field-test Pathways: a fertility preservation patient decision aid website for young women with cancer©.Methods: Using an adapted user-centered design process, our stakeholder advisory group and research team designed and optimized the Pathways patient decision aid website through four iterative cycles of review and revision with clinicians (n = 21) and survivors (n = 14). Field-testing (n = 20 survivors) assessed post-decision aid scores on the Fertility Preservation Knowledge Scale, feasibility of assessing women's decision-making values while using the website, and website usability/acceptability ratings.Results: Iterative stakeholder engagement optimized the Pathways decision aid website to meet survivors' and providers' needs, including providing patient-friendly information and novel features such as interactive value clarification exercises, testimonials that model shared decision making, financial/referral resources, and a printable personal summary. Survivors scored an average of 8.2 out of 13 (SD 1.6) on the Fertility Preservation Knowledge Scale. They rated genetic screening and having a biological child as strong factors in their decision-making, and 71% indicated a preference for egg freezing. Most women (> 85%) rated Pathways favorably, and all women (100%) said they would recommend it to other women.Conclusions: The Pathways decision aid is a usable and acceptable tool to help women learn about fertility preservation.Implications For Cancer Survivors: The Pathways decision aid may help women make well-informed values-based decisions and prevent future infertility-related distress. [ABSTRACT FROM AUTHOR]

Introduction National guidelines recommend that all reproductive-age women with cancer be informed of their fertility risks and offered referral to fertility specialists to discuss fertility preservation options. However, reports indicate that only 5% of patients have consultations, and rates of long-term infertility-related distress remain high. Previous studies report several barriers to fertility preservation; however, initial success has been reported using provider education, patient decision aids and navigation support. This protocol will test effects of a multicomponent intervention compared with usual care on women's fertility preservation knowledge and decision-making outcomes. Methods and analysis This cluster-randomised trial will compare the multicomponent intervention (provider education, patient decision aid and navigation support) with usual care (consultation and referral, if requested). One hundred newly diagnosed English-speaking women of reproductive age who are at risk of cancer-related infertility will be recruited from four regional oncology clinics. The Pathways patient decision aid website provides (1) up-to-date evidence and descriptions of fertility preservation and other family-building options, tailored to cancer type; (2) structured guidance to support personalising the information and informed decision-making; and (3) a printable summary to help women prepare for discussions with their oncologist and/or fertility specialist. Four sites will be randomly assigned to intervention or control groups. Participants will be recruited after their oncology consultation and asked to complete online questionnaires at baseline, 1 week and 2 months to assess their demographics, fertility preservation knowledge, and decision-making process and quality. The primary outcome (decisional conflict) will be tested using Fisher's exact test. Secondary outcomes will be assessed using generalised linear mixed models, and sensitivity analyses will be conducted, as appropriate. Ethics and dissemination The University of Texas MD Anderson Cancer Center provided approval and ongoing review of this protocol. Results will be presented at relevant scientific meetings and submitted for publication in a peer-reviewed journal. Trial registration number NCT03141437; Pre-results. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer screening rates for African American patients remain suboptimal. Patient decision aids designed with an entertainment-education approach have been shown to improve saliency and foster informed decision making. The purpose of this study was to assess whether an entertainment-education decision aid tailored for African American patients improved patients' decision making, attitudes, intentions, or colorectal cancer screening behavior.Methods: Eighty-nine participants were randomized to view 1) a patient decision aid video containing culturally tailored information about colorectal cancer screening options and theory-based support in decision making presented in an entertainment-education format or 2) an attention control video about hypertension that contained similarly detailed information. Participants met with their clinician and then completed follow-up questionnaires assessing their knowledge, decisional conflict, self-advocacy, attitudes, perceived social norms, and intentions. At 3 months, completion of screening was assessed by chart review.Results: Viewing the culturally tailored decision aid significantly increased African American patients' knowledge of colorectal cancer screening recommendations and options. It also significantly reduced their decisional conflict and improved their self-advocacy. No significant differences were observed in participants' attitudes, norms, or intentions. At three months, 23% of all patients had completed a colonoscopy.Conclusions: Designing targeted, engaging patient decision aids for groups that receive suboptimal screening holds promise for improving patient decision making and self-advocacy. Additional research is warranted to investigate the effectiveness of such aids in clinical practices with suboptimal screening rates and on downstream behaviors (such as repeat testing). Cancer 2017;123:1401-1408. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: Patient decision aids aim to present evidence relevant to a health decision in understandable ways to support patients through the process of making evidence-informed, values-congruent health decisions. It is recommended that, when developing these tools, teams involve people who may ultimately use them. However, there is little empirical evidence about how best to undertake this involvement, particularly for specific populations of users such as vulnerable populations.Methods: To describe and compare the development practices of research teams that did and did not specifically involve members of vulnerable populations in the development of patient decision aids, we conducted a secondary analysis of data from a systematic review about the development processes of patient decision aids. Then, to further explain our quantitative results, we conducted semi-structured telephone interviews with 10 teams: 6 that had specifically involved members of vulnerable populations and 4 that had not. Two independent analysts thematically coded transcribed interviews.Results: Out of a total of 187 decision aid development projects, 30 (16%) specifically involved members of vulnerable populations. The specific involvement of members of vulnerable populations in the development process was associated with conducting informal needs assessment activities (73% vs. 40%, OR 2.96, 95% CI 1.18-7.99, P = .02) and recruiting participants through community-based organizations (40% vs. 11%, OR 3.48, 95% CI 1.23-9.83, P = .02). In interviews, all developers highlighted the importance, value and challenges of involving potential users. Interviews with developers whose projects had involved members of vulnerable populations suggested that informal needs assessment activities served to center the decision aid around users' needs, to better avoid stigma, and to ensure that the topic truly matters to the community. Partnering with community-based organizations may facilitate relationships of trust and may also provide a non-threatening and accessible location for research activities.Conclusions: There are a small number of key differences in the development processes for patient decision aids in which members of vulnerable populations were or were not specifically involved. Some of these practices may require additional time or resources. To address health inequities, researchers, communities and funders may need to increase awareness of these approaches and plan accordingly. [ABSTRACT FROM AUTHOR]

Background Over 100 trials show that patient decision aids effectively improve patients' information comprehension and values-based decision making. However, gaps remain in our understanding of several fundamental and applied questions, particularly related to the design of interactive, personalized decision aids. This paper describes an interdisciplinary development process for, and early field testing of, a web-based patient decision support research platform, or virtual decision lab, to address these questions. Methods An interdisciplinary stakeholder panel designed the web-based research platform with three components: a) an introduction to shared decision making, b) a web-based patient decision aid, and c) interactive data collection items. Iterative focus groups provided feedback on paper drafts and online prototypes. A field test assessed a) feasibility for using the research platform, in terms of recruitment, usage, and acceptability; and b) feasibility of using the web-based decision aid component, compared to performance of a videobooklet decision aid in clinical care. Results This interdisciplinary, theory-based, patient-centered design approach produced a prototype for field-testing in six months. Participants (n = 126) reported that: the decision aid component was easy to use (98%), information was clear (90%), the length was appropriate (100%), it was appropriately detailed (90%), and it held their interest (97%). They spent a mean of 36 minutes using the decision aid and 100% preferred using their home/library computer. Participants scored a mean of 75% correct on the Decision Quality, Knowledge Subscale, and 74 out of 100 on the Preparation for Decision Making Scale. Completing the web-based decision aid reduced mean Decisional Conflict scores from 31.1 to 19.5 (p < 0.01). Conclusions Combining decision science and health informatics approaches facilitated rapid development of a web-based patient decision support research platform that was feasible for use in research studies in terms of recruitment, acceptability, and usage. Within this platform, the web-based decision aid component performed comparably with the videobooklet decision aid used in clinical practice. Future studies may use this interactive research platform to study patients' decision making processes in real-time, explore interdisciplinary approaches to designing web-based decision aids, and test strategies for tailoring decision support to meet patients' needs and preferences. [ABSTRACT FROM AUTHOR]

Background: In 2005, the International Patient Decision Aids Standards Collaboration identified twelve quality dimensions to guide assessment of patient decision aids. One dimension-the delivery of patient decision aids on the Internet-is relevant when the Internet is used to provide some or all components of a patient decision aid. Building on the original background chapter, this paper provides an updated definition for this dimension, outlines a theoretical rationale, describes current evidence, and discusses emerging research areas. Methods: An international, multidisciplinary panel of authors examined the relevant theoretical literature and empirical evidence through 2012. Results: The updated definition distinguishes Internet-delivery of patient decision aids from online health information and clinical practice guidelines. Theories in cognitive psychology, decision psychology, communication, and education support the value of Internet features for providing interactive information and deliberative support. Dissemination and implementation theories support Internet-delivery for providing the right information (rapidly updated), to the right person (tailored), at the right time (the appropriate point in the decision making process). Additional efforts are needed to integrate the theoretical rationale and empirical evidence from health technology perspectives, such as consumer health informatics, user experience design, and human-computer interaction. Despite Internet usage ranging from 74% to 85% in developed countries and 80% of users searching for health information, it is unknown how many individuals specifically seek patient decision aids on the Internet. Among the 86 randomized controlled trials in the 2011 Cochrane Collaboration's review of patient decision aids, only four studies focused on Internet-delivery. Given the limited number of published studies, this paper particularly focused on identifying gaps in the empirical evidence base and identifying emerging areas of research. Conclusions: As of 2012, the updated theoretical rationale and emerging evidence suggest potential benefits to delivering patient decision aids on the Internet. However, additional research is needed to identify best practices and quality metrics for Internet-based development, evaluation, and dissemination, particularly in the areas of interactivity, multimedia components, socially-generated information, and implementation strategies. [ABSTRACT FROM AUTHOR]