Clarifying Values: An Updated and Expanded Systematic Review and Meta-Analysis.

BACKGROUND: Patient decision aids should help people make evidence-informed decisions aligned with their values. There is limited guidance about how to achieve such alignment. PURPOSE: To describe the range of values clarification methods available to patient decision aid developers, synthesize evidence regarding their relative merits, and foster collection of evidence by offering researchers a proposed set of outcomes to report when evaluating the effects of values clarification methods. DATA SOURCES: MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, and CINAHL. STUDY SELECTION: We included articles that described randomized trials of 1 or more explicit values clarification methods. From 30,648 records screened, we identified 33 articles describing trials of 43 values clarification methods. DATA EXTRACTION: Two independent reviewers extracted details about each values clarification method and its evaluation. DATA SYNTHESIS: Compared to control conditions or to implicit values clarification methods, explicit values clarification methods decreased the frequency of values-incongruent choices (risk difference, -0.04; 95% confidence interval [CI], -0.06 to -0.02; P < 0.001) and decisional conflict (standardized mean difference, -0.20; 95% CI, -0.29 to -0.11; P < 0.001). Multicriteria decision analysis led to more values-congruent decisions than other values clarification methods (χ2 = 9.25, P = 0.01). There were no differences between different values clarification methods regarding decisional conflict (χ2 = 6.08, P = 0.05). LIMITATIONS: Some meta-analyses had high heterogeneity. We grouped values clarification methods into broad categories. CONCLUSIONS: Current evidence suggests patient decision aids should include an explicit values clarification method. Developers may wish to specifically consider multicriteria decision analysis. Future evaluations of values clarification methods should report their effects on decisional conflict, decisions made, values congruence, and decisional regret.

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

BACKGROUND: 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. OBJECTIVE: To summarize and update the evidence used to inform the systematic development of patient decision aids from the IPDAS Collaboration. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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].

Harmonizing evidence-based practice, implementation context, and implementation strategies with user-centered design: a case example in young adult cancer care.

BACKGROUND: Attempting to implement evidence-based practices in contexts for which they are not well suited may compromise their fidelity and effectiveness or burden users (e.g., patients, providers, healthcare organizations) with elaborate strategies intended to force implementation. To improve the fit between evidence-based practices and contexts, implementation science experts have called for methods for adapting evidence-based practices and contexts and tailoring implementation strategies; yet, methods for considering the dynamic interplay among evidence-based practices, contexts, and implementation strategies remain lacking. We argue that harmonizing the three can be facilitated by user-centered design, an iterative and highly stakeholder-engaged set of principles and methods. METHODS: This paper presents a case example in which we used a three-phase user-centered design process to design and plan to implement a care coordination intervention for young adults with cancer. Specifically, we used usability testing to redesign and augment an existing patient-reported outcome measure that served as the basis for our intervention to optimize its usability and usefulness, ethnographic contextual inquiry to prepare the context (i.e., a comprehensive cancer center) to promote receptivity to implementation, and iterative prototyping workshops with a multidisciplinary design team to design the care coordination intervention and anticipate implementation strategies needed to enhance contextual fit. RESULTS: Our user-centered design process resulted in the Young Adult Needs Assessment and Service Bridge (NA-SB), including a patient-reported outcome measure and a collection of referral pathways that are triggered by the needs young adults report, as well as implementation guidance. By ensuring NA-SB directly responded to features of users and context, we designed NA-SB for implementation, potentially minimizing the strategies needed to address misalignment that may have otherwise existed. Furthermore, we designed NA-SB for scale-up; by engaging users from other cancer programs across the country to identify points of contextual variation which would require flexibility in delivery, we created a tool intended to accommodate diverse contexts. CONCLUSIONS: User-centered design can help maximize usability and usefulness when designing evidence-based practices, preparing contexts, and informing implementation strategies-in effect, harmonizing evidence-based practices, contexts, and implementation strategies to promote implementation and effectiveness.

An 11-Item Measure of User- and Human-Centered Design for Personal Health Tools (UCD-11): Development and Validation.

BACKGROUND: Researchers developing personal health tools employ a range of approaches to involve prospective users in design and development. OBJECTIVE: The aim of this paper was to develop a validated measure of the human- or user-centeredness of design and development processes for personal health tools. METHODS: We conducted a psychometric analysis of data from a previous systematic review of the design and development processes of 348 personal health tools. Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis. RESULTS: We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. The Cronbach alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver, or surrogate users were involved in the steps that help tool developers understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool or (5) involved in steps intended to evaluate the tool, (6) the process had 3 or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion and (9) consulted before the first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved. CONCLUSIONS: The User-Centered Design 11-item measure (UCD-11) may be used to quantitatively document the user/human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to people who will use them, rather than requiring people to adapt to tools.

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

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.

Designing Emails Aimed at Increasing Family Physicians' Use of a Web-Based Audit and Feedback Tool to Improve Cancer Screening Rates: Cocreation Process.

BACKGROUND: Providing clinical performance data to health professionals, a process known as audit and feedback, can play an important role in health system improvement. However, audit and feedback tools can only be effective if the targeted health professionals access and actively review their data. Email is used by Cancer Care Ontario, a provincial cancer agency, to promote access to a Web-based audit and feedback tool called the Screening Activity Report (SAR); however, current emails that lack behavior change content have been ineffective at encouraging log-in to the SAR. OBJECTIVE: The objective of our study was to describe the process and experience of developing email content that incorporates user input and behavior change techniques (BCTs) to promote the use of the SAR among Ontario primary care providers. METHODS: Our interdisciplinary research team first identified BCTs shown to be effective in other settings that could be adapted to promote use of the SAR. We then developed draft BCT-informed email content. Next, we conducted cocreation workshops with physicians who had logged in to the SAR more than once over the past year. Participants provided reactions to researcher-developed BCT-informed content and helped to develop an email that they believed would prompt their colleagues to use the SAR. Content from cocreation workshops was brought to focus groups with physicians who had not used the SAR in the past year. We analyzed notes from the cocreation workshops and focus groups to inform decisions about content. Finally, 8 emails were created to test BCT-informed content in a 2×2×2 factorial randomized experiment. RESULTS: We identified 3 key tensions during the development of the email that required us to balance user input with scientific evidence, organizational policies, and our scientific objectives, which are as follows: conflict between user preference and scientific evidence, privacy constraints around personalizing unencrypted emails with performance data, and using cocreation methods in a study with the objective of developing an email that featured BCT-informed content. CONCLUSIONS: Teams tasked with developing content to promote health professional engagement with audit and feedback or other quality improvement tools might consider cocreation processes for developing communications that are informed by both users and BCTs. Teams should be cautious about making decisions solely based on user reactions because what users seem to prefer is not always the same as what works. Furthermore, implementing user recommendations may not always be feasible. Teams may face challenges when using cocreation methods to develop a product with the simultaneous goal of having clearly defined variables to test in later studies. The expected role of users, evidence, and the implementation context all warrant consideration to determine whether and how cocreation methods could help to achieve design and scientific objectives.

Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial Randomized Experiment of Email Content.

BACKGROUND: Cancer Care Ontario's Screening Activity Report (SAR) is an online audit and feedback tool designed to help primary care physicians in Ontario, Canada, identify patients who are overdue for cancer screening or have abnormal results requiring follow-up. Use of the SAR is associated with increased screening rates. To encourage SAR use, Cancer Care Ontario sends monthly emails to registered primary care physicians announcing that updated data are available. However, analytics reveal that 50% of email recipients do not open the email and less than 7% click the embedded link to log in to their report. OBJECTIVE: The goal of the study is to determine whether rewritten emails result in increased log-ins. This manuscript describes how different user- and theory-informed messages intended to improve the impact of the monthly emails will be experimentally tested and how a process evaluation will explore why and how any effects observed were (or were not) achieved. METHODS: A user-centered approach was used to rewrite the content of the monthly email, including messages operationalizing 3 behavior change techniques: anticipated regret, material incentive (behavior), and problem solving. A pragmatic, 2x2x2 factorial experiment within a multiphase optimization strategy will test the redesigned emails with an embedded qualitative process evaluation to understand how and why the emails may or may not have worked. Trial outcomes will be ascertained using routinely collected administrative data. Physicians will be recruited for semistructured interviews using convenience and snowball sampling. RESULTS: As of April 2017, 5576 primary care physicians across the province of Ontario, Canada, had voluntarily registered for the SAR, and in so doing, signed up to receive the monthly email updates. From May to August 2017 participants received the redesigned monthly emails with content specific to their allocated experimental condition prompting use of the SAR. We have not yet begun analyses. CONCLUSIONS: This study will inform how to communicate effectively with primary care providers by email and identify which behavior change techniques tested are most effective at encouraging engagement with an audit and feedback report. TRIAL REGISTRATION: ClinicalTrials.gov NCT03124316; https://clinicaltrials.gov/ct2/show/NCT03124316 (Archived by WebCite at http://www.webcitation.org/6w2MqDWGu).

Involving members of vulnerable populations in the development of patient decision aids: a mixed methods sequential explanatory study.

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.

User-centered design and the development of patient decision aids: protocol for a systematic review.

BACKGROUND: Providing patient-centered care requires that patients partner in their personal health-care decisions to the full extent desired. Patient decision aids facilitate processes of shared decision-making between patients and their clinicians by presenting relevant scientific information in balanced, understandable ways, helping clarify patients' goals, and guiding decision-making processes. Although international standards stipulate that patients and clinicians should be involved in decision aid development, little is known about how such involvement currently occurs, let alone best practices. This systematic review consisting of three interlinked subreviews seeks to describe current practices of user involvement in the development of patient decision aids, compare these to practices of user-centered design, and identify promising strategies. METHODS/DESIGN: A research team that includes patient and clinician representatives, decision aid developers, and systematic review method experts will guide this review according to the Cochrane Handbook and PRISMA reporting guidelines. A medical librarian will hand search key references and use a peer-reviewed search strategy to search MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, the ACM library, IEEE Xplore, and Google Scholar. We will identify articles across all languages and years describing the development or evaluation of a patient decision aid, or the application of user-centered design or human-centered design to tools intended for patient use. Two independent reviewers will assess article eligibility and extract data into a matrix using a structured pilot-tested form based on a conceptual framework of user-centered design. We will synthesize evidence to describe how research teams have included users in their development process and compare these practices to user-centered design methods. If data permit, we will develop a measure of the user-centeredness of development processes and identify practices that are likely to be optimal. DISCUSSION: This systematic review will provide evidence of current practices to inform approaches for involving patients and other stakeholders in the development of patient decision aids. We anticipate that the results will help move towards the establishment of best practices for the development of patient-centered tools and, in turn, help improve the experiences of people who face difficult health decisions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014013241.

Hoxa9 collaborates with E2A-PBX1 in mouse B cell leukemia in association with Flt3 activation and decrease of B cell gene expression.

BACKGROUND: The fusion protein E2A-PBX1 induces pediatric B cell leukemia in human. Previously, we reported oncogenic interactions between homeobox (Hox) genes and E2A-PBX1 in murine T cell leukemia. A proviral insertional mutagenesis screen with our E2A-PBX1 B cell leukemia mouse model identified Hoxa genes as potential collaborators to E2A-PBX1. Here we studied whether Hoxa9 could enhance E2A-PBX1 leukemogenesis. RESULTS: We show that Hoxa9 confers a proliferative advantage to E2A-PBX1 B cells. Transplantation experiments with E2A-PBX1 transgenic B cells overexpressing Hoxa9 isolated from bone marrow chimeras showed that Hoxa9 accelerates the generation of E2A-PBX1 B cell leukemia, but Hoxa9 is unable to transform B cells alone. Quantitative-reverse transcriptase polymerase chain reaction analysis demonstrated a strong repression of B cell specific genes in these E2A-PBX1/Hoxa9 leukemias in addition to Flt3 activation, indicating inhibition of B cell differentiation in combination with enhanced proliferation. Overexpression of Hoxa9 in established E2A-PBX1 mouse leukemic B cells resulted in a growth advantage in vitro, which was also characterized by an enhanced expression of Flt3. CONCLUSIONS: we show for the first time that Hoxa9 collaborates with E2A-PBX1 in the oncogenic transformation of B cells in a mouse model that involves Flt3 signaling, which is potentially relevant to human disease.