Applying cognitive walkthrough methodology to improve the usability of an equity-focused implementation strategy.

BACKGROUND: Our research team partnered with primary care and quality improvement staff in Federally Qualified Community Health Centers (CHCs) to develop Partnered and Equity Data-Driven Implementation (PEDDI) to promote equitable implementation of evidence-based interventions. The current study used a human-centered design methodology to evaluate the usability of PEDDI and generate redesign solutions to address usability issues in the context of a cancer screening intervention. METHODS: We applied the Cognitive Walkthrough for Implementation Strategies (CWIS), a pragmatic assessment method with steps that include group testing with end users to identify and prioritize usability problems. We conducted three facilitated 60-min CWIS sessions with end users (N = 7) from four CHCs that included scenarios and related tasks for implementing a colorectal cancer (CRC) screening intervention. Participants rated the likelihood of completing each task and identified usability issues and generated ideas for redesign solutions during audio-recorded CWIS sessions. Participants completed a pre-post survey of PEDDI usability. Our research team used consensus coding to synthesize usability problems and redesign solutions from transcribed CWIS sessions. RESULTS: Usability ratings (scale 0-100: higher scores indicating higher usability) of PEDDI averaged 66.3 (SD = 12.4) prior to the CWIS sessions. Scores averaged 77.8 (SD = 9.1) following the three CWIS sessions improving usability ratings from "marginal acceptability" to "acceptable". Ten usability problems were identified across four PEDDI tasks, comprised of 2-3 types of usability problems per task. CWIS participants suggested redesign solutions that included making data fields for social determinants of health and key background variables for identifying health equity targets mandatory in the electronic health record and using asynchronous communication tools to elicit ideas from staff for adaptations. CONCLUSIONS: Usability ratings indicated PEDDI was in the acceptable range following CWIS sessions. Staff identified usability problems and redesign solutions that provide direction for future improvements in PEDDI. In addition, this study highlights opportunities to use the CWIS methodology to address inequities in the implementation of cancer screening and other clinical innovations in resource-constrained healthcare settings.

Improving Interdisciplinary Communication and Pathology Reporting for Head and Neck Cancer Resections: 3D Visualizations and Margin Reconciliation.

PURPOSE: Surgical pathology reports play an integral role in postoperative management of head and neck cancer patients. Pathology reports of complex head and neck resections must convey critical information to all involved clinicians. Previously, we demonstrated the utility of 3D specimen and defect scanning for communicating margin status and documenting the location of supplemental margins. We introduce a newly designed permanent pathology report which improves documentation of intraoperative margin mapping and extent of corresponding supplemental margins harvested. METHODS: We test the hypothesis that gaps in understanding exist for head and neck resection pathology reports across providers. A cross-sectional exploratory study using human-centered design was implemented to evaluate the existing permanent pathology report with respect to understanding margin status. Pathologists, surgeons, radiation oncologists, and medical oncologists from United States-based medical institutions were surveyed. The results supported a redesign of our surgical pathology template, incorporating 3D specimen / defect scans and annotated radiographic images indicating the location of inadequate margins requiring supplemental margins, or indicating frankly positive margins discovered on permanent section. RESULTS: Forty-seven physicians completed our survey. Analyzing surgical pathology reports, 28/47 (60%) respondents reported confusion whether re-excised supplemental margins reflected clear margins, 20/47 (43%) reported uncertainty regarding final margin status, and 20/47 (43%) reported the need for clarity regarding the extent of supplemental margins harvested intraoperatively. From this feedback, we designed a new pathology report template; 61 permanent pathology reports were compiled with this new template over a 12-month period. CONCLUSION: Feedback from survey respondents led to a redesigned permanent pathology report that offers detailed visual anatomic information regarding intraoperative margin findings and exact location/size of harvested supplemental margins. This newly designed report reconciles frozen and permanent section results and includes annotated radiographic images such that clinicians can discern precise actions taken by surgeons to address inadequate margins, as well as to understand the location of areas of concern that may influence adjuvant radiation planning.

EHR-Driven Delivery of EPA Assessments Significantly Improves Participation.

INTRODUCTION: Digital education tools are a cornerstone in the evolution to CBME through EPAs. Successful implementation requires understanding the variable impacts of EHR-driven delivery of EPAs, flexible digital device access to EPAs, and user-behavior trends. METHODS: Through a HIPAA compliant, flexible-device accessible, surgical education platform, general surgery training programs at 21 institutions collected EPA from July 2023 to April 2024. At 5 EHR-integrated institutions (EHR+), EPA were created for clinical activities based on the OR schedule, automatically pushed to attendings and residents with built in completion reminders. At 16 institutions without EHR integration (EHR-), EPA were initiated manually. To improve user experience, care phases were bundled (cEPA). We compared the EHR+ and EHR- groups, computing descriptive statistics on the cEPAs completed and user behavior metrics. RESULTS: We collected 4187 cEPAs in total, with 82% at EHR+ institutions and 18% at EHR- institutions. Platform triggering dramatically drove cEPA completion for both faculty and residents, 88% and 81%, respectively. Only 3% were initiated by the faculty or resident. Faculty at EHR+ institutions strongly preferred the automated OR-triggered workflow to start their EPAs (Chi-squared test, p ≈ 0). Faculty completed all 3 care phases nearly 80% of the time. Time reminders specifically drive EPA completion for residents and faculty on weekdays and build habits on weekends. 71% of cEPAs completed were by computer, and 29% by phone. More comments were provided when computers were used. Residents reviewed feedback with a median lag of 1 hour and 29 min after results were available. CONCLUSIONS: EHR-driven delivery of EPA leads to a 4.6-fold increase in EPAs completed. EPA initiation is the most critical phase in the workflow and EHR-data driven alerts drive this action. These alerts are also effective drivers of habit formation. Flexible device access is important to increase EPAs completed and improve the usefulness through comments for residents.

Incorporating the perspectives of participants and research coordinators on home spirometry into clinical trial design: The example of the OUTREACH study.

BACKGROUND: We undertook a human-centered design approach to design the OUTREACH study of home spirometry as a CF clinical trial endpoint. We conducted a qualitative needs assessment to elicit the perspectives of people with CF (PwCF) and research coordinators (RCs) about home spirometry in the research setting and co-produced written and video home spirometry instructions in partnership with representatives from these stakeholder groups. METHODS: We conducted 7 focus groups of PwCF (N = 27), caregivers of children with CF (N = 6), or RCs (N = 24) to elicit current experiences, barriers and facilitators of home spirometry across 6 target areas, followed by discussion and prioritization. The co-production team, composed of 3 PwCF, 3 RCs and study team members created written and video training materials. RESULTS: While most PwCF and caregivers found home spirometry convenient, many experienced technical barriers, reported a "learning curve", and expressed uncertainty about the quality and reliability of measurements. Major barriers identified by RCs included tailoring participant training to individual needs, scheduling remote coaching, and performing effective coaching remotely. Participants offered age-specific recommendations in key domains: training materials and procedures, remote coaching, monitoring progress and maintaining engagement. Co-produced training materials included handouts and videos on how to perform spirometry, and troubleshooting, cleaning, and maintaining home spirometers. CONCLUSIONS: The OUTREACH design was improved by incorporating results of the needs assessment. The home spirometry training materials are freely available for public use. We hope our results and materials can help to inform the design and success of remote clinical trials of the future.

Teach Design to Surgical Trainees: One Small Step for Surgeons, One Giant Leap for Surgery.

The field of surgery faces complex, systemic challenges that will require new academic frameworks. In this paper, we propose design thinking as a useful problem-solving technique to apply to such challenges. We define design thinking and provide a brief history of this practice. Finally, we offer suggestions to introduce design thinking to surgical trainees, drawing from the experience of innovation programs that have incorporated this technique.

Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening.

BACKGROUND: Implementation strategies are strategies to improve uptake of evidence-based practices or interventions and are essential to implementation science. Developing or tailoring implementation strategies may benefit from integrating approaches from other disciplines; yet current guidance on how to effectively incorporate methods from other disciplines to develop and refine innovative implementation strategies is limited. We describe an approach that combines community-engaged methods, human-centered design (HCD) methods, and causal pathway diagramming (CPD)-an implementation science tool to map an implementation strategy as it is intended to work-to develop innovative implementation strategies. METHODS: We use a case example of developing a conversational agent or chatbot to address racial inequities in breast cancer screening via mammography. With an interdisciplinary team including community members and operational leaders, we conducted a rapid evidence review and elicited qualitative data through interviews and focus groups using HCD methods to identify and prioritize key determinants (facilitators and barriers) of the evidence-based intervention (breast cancer screening) and the implementation strategy (chatbot). We developed a CPD using key determinants and proposed strategy mechanisms and proximal outcomes based in conceptual frameworks. RESULTS: We identified key determinants for breast cancer screening and for the chatbot implementation strategy. Mistrust was a key barrier to both completing breast cancer screening and using the chatbot. We focused design for the initial chatbot interaction to engender trust and developed a CPD to guide chatbot development. We used the persuasive health message framework and conceptual frameworks about trust from marketing and artificial intelligence disciplines. We developed a CPD for the initial interaction with the chatbot with engagement as a mechanism to use and trust as a proximal outcome leading to further engagement with the chatbot. CONCLUSIONS: The use of interdisciplinary methods is core to implementation science. HCD is a particularly synergistic discipline with multiple existing applications of HCD to implementation research. We present an extension of this work and an example of the potential value in an integrated community-engaged approach of HCD and implementation science researchers and methods to combine strengths of both disciplines and develop human-centered implementation strategies rooted in causal perspective and healthcare equity.

Engaging Cancer Care Physicians in Off-Label Drug Clinical Trials: Human-Centered Design Approach.

BACKGROUND: Using a human-centered design (HCD) approach can provide clinical trial design teams with a better understanding of the needs, preferences, and attitudes of clinical trial stakeholders. It can also be used to understand the challenges and barriers physician stakeholders face in initiating and completing clinical trials, especially for using off-label drugs (OLDs) to treat unmet clinical needs in cancer treatment. However, the HCD approach is not commonly taught in the context of clinical trial design, and few step-by-step guides similar to this study are available to demonstrate its application. OBJECTIVE: This study aims to demonstrate the feasibility and process of applying an HCD approach to creating clinical trial support resources for physician stakeholders to overcome barriers to pursuing clinical trials for OLDs to treat cancer. METHODS: An HCD approach was used to develop OLD clinical trial support concepts. In total, 45 cancer care physicians were contacted, of which 15 participated in semistructured interviews to identify barriers to prescribing OLDs or participating in cancer OLD clinical trials. Design research is qualitative-it seeks to answer "why" and "how" questions; thus, a sample size of 15 was sufficient to provide insight saturation to address the design problem. The team used affinity mapping and thematic analysis of qualitative data gathered from the interviews to inform subsequent web-based co-design sessions, which included creative matrix exercises and voting to refine and prioritize the ideas used in the final 3 recommended concepts. RESULTS: The findings demonstrate the potential of HCD methods to uncover important insights into the barriers physicians face in participating in OLD clinical trials or prescribing OLDs, such as recruitment challenges, low willingness to prescribe without clinical data, and stigma. Notably, only palliative care participants self-identified as "frequent prescribers" of OLDs, despite high national OLD prescription rates among patients with cancer. Participants found the HCD approach engaging, with 60% (9/15) completing this study; scheduling conflicts caused most of the dropouts. Over 150 ideas were generated in 3 co-design sessions, with the groups voting on 15 priority ideas that the design team then refined into 3 final recommendations, especially focused on increasing the participation of physicians in OLD clinical trials. CONCLUSIONS: Using participatory HCD methods, we delivered 3 concepts for clinical trial support resources to help physician stakeholders overcome barriers to pursuing clinical trials for OLDs to treat cancer. Overall, integrating the HCD approach can aid in identifying important stakeholders, such as prescribing physicians; facilitating their engagement; and incorporating their perspectives and needs into the solution design process. This paper highlights the process, methods, and potential of HCD to improve cancer clinical trial design. Future work is needed to train clinical trial designers in the HCD approach and encourage adoption in the field.

Using implementation science to develop a familial hypercholesterolemia screening program in primary care: The CARE-FH study.

BACKGROUND: We designed the Collaborative Approach to Reach Everyone with Familial Hypercholesterolemia (CARE-FH) clinical trial to improve FH screening in primary care and facilitate guideline-based care. OBJECTIVE: The goal was to incorporate perspectives from end-users (healthcare system leaders, primary care clinicians, cardiologists, genetic counselors, nurses, and clinic staff) and improve translation of screening guidance into practice. METHODS: We partnered with end-users to sequentially define the current state of FH screening, assess acceptability, feasibility, and appropriateness of implementing an FH screening program, and select clinically actionable strategies at the patient-, clinician-, and system-level to be deployed as a package in the CARE-FH clinical trial. Methods informed by implementation science and human centered design included: contextual inquiries, surveys, and deliberative engagement sessions. RESULTS: Screening for FH occurred rarely in primary care, and then only after a cardiovascular event or sometimes due to a family history of high cholesterol or early heart attack. Surveys suggested FH screening in primary care was acceptable, appropriate, and feasible. Reported and observed barriers to screening include insufficient time at patient encounters to screen, cost and convenience of testing for patients, and knowledge regarding causes of dyslipidemia. Facilitators included clear guidance on screening criteria and new therapies to treat FH. These results led to the development of multilevel strategies that were presented to end-users, modified, and then pilot tested in one primary care clinic. CONCLUSIONS: A refined implementation strategy package for FH screening was created with a goal of improving FH awareness, identification, and initiation of guideline-based care. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05284513?id=NCT05284513&rank=1 Unique Identifier: NCT05284513.

Multilevel needs assessment of physical activity, sport, psychological needs, and nutrition in rural children and adults.

Introduction: Physical activity yields significant benefits, yet fewer than 1 in 4 youth meet federal guidelines. Children in rural areas from low socioeconomic (SES) backgrounds face unique physical activity contextual challenges. In line with Stage 0 with the NIH Stage Model for Behavioral Intervention Development, the objective of the present study was to conduct a community-engaged needs assessment survey with middle school children and adults to identify perceptions, barriers, and facilitators of physical activity, sport, psychological needs, and nutrition from a multi-level lens. Methods: A cross-sectional survey data collection was conducted with children (n = 39) and adults (n = 63) from one middle school community in the Midwestern United States. The child sample was 33% 6th grade; 51% 7th grade and was 49% female. The adult sample was primarily between 30 and 39 years old (70%) and comprised predominantly of females (85%). Multi-level survey design was guided by the psychological needs mini-theory within self-determination theory and aimed to identify individual perceptions, barriers, and facilitators in line with the unique context of the community. Results: At the individual level, 71.8% of children and 82.2% of the overall sample (children and adults) were interested in new physical activity/sport programming for their school. Likewise, 89.7% of children and 96.8% of adults agree that PA is good for physical health. For basic psychological needs in the overall sample, relatedness was significantly greater than the autonomy and competence subscales. Children's fruit and vegetable intake were below recommended levels, yet only 43.6% of children were interested in nutritional programming. Conversely, 61.5% indicated interest at increasing leadership skills. At the policy-systems-environmental level, the respondents' feedback indicated that the condition and availability of equipment are areas in need of improvement to encourage more physical activity. Qualitative responses are presented within for physical activity-related school policy changes. Discussion: Interventions addressing children's physical activity lack sustainability, scalability, and impact due to limited stakeholder involvement and often neglect early behavioral intervention stages. The present study identified perspectives, barriers, and facilitators of physical activity, sport, psychological needs, and nutrition in a multi-level context and forms the initial campus-community partnership between scientists and community stakeholders.

Design and Early Evaluation of a Device to Improve the Sharp Count Process in Operating Rooms.

NEED: Counting surgical sharps in surgeries mitigates the risk of retained surgical items in patients. Current procedures rely on manual counts throughout and at the end of each surgery. The manual count is lengthy, burdensome, and carries the risk of injuries. TECHNICAL SOLUTION: This paper presents the design and early evaluation of a technology aid to automatize the sharps' counting process; it is composed of a shell holding a set of optical sensors that count needles that pass through the shell's top slot. PROOF OF CONCEPT: The device was tested with needles originating from 20 surgeries. Users surveyed reported a decrease in counting time and perceived injury risk. The average count error was 4.4%, indicating the need to continue advancing the technology. NEXT STEPS: The counting technology needs to be refined to increase accuracy, and a user guide for the equipment must be prepared. Thereafter, a new set of trials must be performed. CONCLUSION: Our work provides a detailed requirements list for developing a technology aid to improve the needle count process and investigates one possible technological route to address this problem.

Integrating Human-Centered Design Methods Into a Health Promotion Project: Supplemental Nutrition Assistance Program Education Case Study for Intervention Design.

BACKGROUND: Human-centered design, or design thinking, offers an extensive toolkit of methods and strategies for user-centered engagement that lends itself well to intervention development and implementation. These methods can be applied to the fields of public health and medicine to design interventions that may be more feasible and viable in real-world contexts than those developed with different methods. OBJECTIVE: The design team aimed to develop approaches to building food skills among caregivers of children aged 0-5 years who are eligible for a federal food assistance program while they were in the grocery store. METHODS: They applied 3 specific human-centered design methods-Extremes and Mainstreams, Journey Mapping, and Co-Creation Sessions-to collaboratively develop intervention approaches to enhance Supplemental Nutrition Assistance Program Education (SNAP-Ed) reach and impact across food retail settings. Extremes and Mainstreams is a specific kind of purposive sampling that selects individuals based on characteristics beyond demographics. Journey Mapping is a visual tool that asks individuals to identify key moments and decision points during an experience. Co-Creation Sessions are choreographed opportunities for individuals to explicitly contribute to the design of a solution alongside research or design team members. RESULTS: Ten caregivers with diverse lived experiences were selected to participate in remote design thinking workshops and create individual journey maps to depict their grocery store experiences. Common happy points and pain points were identified. Nine stakeholders, including caregivers, SNAP-Ed staff, and grocery store dieticians, cocreated 2 potential intervention approaches informed by caregivers' experiences and needs: a rewards program and a meal box option. CONCLUSIONS: These 3 human-centered design methods led to a meaningful co-design process where proposed interventions aligned with caregivers' wants and needs. This case study provides other public health practitioners with specific examples of how to use these methods in program development and stakeholder engagement as well as lessons learned when adapting these methods to remote settings.

Human-Centered Design Study to Inform Traceback Cascade Genetic Testing Programs at Three Integrated Health Systems.

INTRODUCTION: A traceback genetic testing program for ovarian cancer has the potential to identify individuals with hereditary breast and ovarian cancer and their relatives. Successful implementation depends on understanding and addressing the experiences, barriers, and preferences of the people served. METHODS: We conducted a remote, human-centered design research study of people with ovarian, fallopian tube, or peritoneal cancer (probands) and people with a family history of ovarian cancer (relatives) at three integrated health systems between May and September 2021. Participants completed activities to elicit their preferences about ovarian cancer genetic testing messaging and to design their ideal experience receiving an invitation to participate in genetic testing. Interview data were analyzed using a rapid thematic analysis approach. RESULTS: We interviewed 70 participants and identified five preferred experiences for a traceback program. Participants strongly prefer discussing genetic testing with their doctor but are comfortable discussing with other clinicians. The most highly preferred experience for both probands and relatives was to discuss with a knowledgeable clinician who could answer questions, followed by directed (sent directly to specific people) or passive (shared in a public area) communication. Repeated contact was acceptable for reminders. CONCLUSION: Participants were open to receiving information about traceback genetic testing and recognized its value. Participants preferred discussing genetic testing with a trusted clinician. Directed communication was preferable to passive communication. Other valued information included how genetic tests help their family and the cost of genetic testing. These findings are informing traceback cascade genetic testing programs at all three sites.

Defending Against Medical Error: Personal Reflections on the Legacy of John Senders.

OBJECTIVE: To honor the legacy of John Senders, a distinguished member of the Human Factors and Ergonomics Society, by a short, personal history of him, but then to honor his legacy by extending it through our own professional opinions, with an emphasis on the study of human error and its implications for healthcare systems-two topics in which he excelled. BACKGROUND: The authors are familiar with the topic and subject matter. One was a friend of Senders for over 50 years. Another was a collaborator and joint author with Senders (as well as his stepdaughter). All three authors have extensive publications in the topic areas. METHOD, RESULTS, AND CONCLUSION: The authors used personal accounts of interactions with Senders at conferences, experiences living and working with him, and a brief review of his most personal, notable publications in healthcare. The reflections indicate a strong resonance on Senders' contributions to system design that are relevant today in healthcare's most challenging period in its history.

Understanding Design Approaches and Evaluation Methods in mHealth Apps Targeting Substance Use: Protocol for a Systematic Review.

BACKGROUND: Substance use and use disorders in the United States have had significant and devastating impacts on individuals and communities. This escalating substance use crisis calls for urgent and innovative solutions to effectively detect and provide interventions for individuals in times of need. Recent mobile health (mHealth)-based approaches offer promising new opportunities to address these issues through ubiquitous devices. However, the design rationales, theoretical frameworks, and mechanisms through which users' perspectives and experiences guide the design and deployment of such systems have not been analyzed in any prior systematic reviews. OBJECTIVE: In this paper, we systematically review these approaches and apps for their feasibility, efficacy, and usability. Further, we evaluate whether human-centered research principles and techniques guide the design and development of these systems and examine how the current state-of-the-art systems apply to real-world contexts. In an effort to gauge the applicability of these systems, we also investigate whether these approaches consider the effects of stigma and privacy concerns related to collecting data on substance use. Lastly, we examine persistent challenges in the design and large-scale adoption of substance use intervention apps and draw inspiration from other domains of mHealth to suggest actionable reforms for the design and deployment of these apps. METHODS: Four databases (PubMed, IEEE Xplore, JMIR, and ACM Digital Library) were searched over a 5-year period (2016-2021) for articles evaluating mHealth approaches for substance use (alcohol use, marijuana use, opioid use, tobacco use, and substance co-use). Articles that will be included describe an mHealth detection or intervention targeting substance use, provide outcomes data, and include a discussion of design techniques and user perspectives. Independent evaluation will be conducted by one author, followed by secondary reviewer(s) who will check and validate themes and data. RESULTS: This is a protocol for a systematic review; therefore, results are not yet available. We are currently in the process of selecting the studies for inclusion in the final analysis. CONCLUSIONS: To the best of our knowledge, this is the first systematic review to assess real-world applicability, scalability, and use of human-centered design and evaluation techniques in mHealth approaches targeting substance use. This study is expected to identify gaps and opportunities in current approaches used to develop and assess mHealth technologies for substance use detection and intervention. Further, this review also aims to highlight various design processes and components that result in engaging, usable, and effective systems for substance use, informing and motivating the future development of such systems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35749.

Using Human-Centered Design to Improve a Surgery Resident Well-Being Program.

INTRODUCTION: Surgery resident mental health, burnout, and overall well-being are constantly scrutinized, and improving surgery resident well-being programs continuously requires refinement. We sought to evaluate the effectiveness of human-centered design (HCD) sprints to enhance our surgery resident well-being program. METHODS: An HCD sprint was conducted with 34 surgery residents in a single session using seven separate domains, including Mental Health/Reflection and Therapy; Mentoring or Faculty Engagement; Physical Well-being; Retreats; Scheduled Breaks or Free Time; Social Connection; and Well-being Lectures, Emails, or Curriculum. Responses were characterized as: "How might we", Suggestions, Useful, and Not Useful. RESULTS: Well-being Lectures, Emails, or Curriculum were overwhelmingly viewed, as Not Useful (77%), as was Mental Health/Reflection and Therapy (42%). Scheduled Breaks or Free Time was viewed as the most Useful (42%). This category also had the most suggestions and "How might we" ideas for improvement (41%). Lastly, Suggestions and "How might we" ideas were also common for improving Mentoring or Faculty Engagement (31% and 29%, respectively). These results were incorporated into multiple strategies to improve surgery resident well-being and also shared in a Department of Surgery Grand Rounds. CONCLUSIONS: Surgery resident well-being and a targeted approach by a well-being program are critical to a residency program, particularly with the arduous nature of surgical training during the pandemic resulting in periods of prolonged social isolation. HCD sprints are an effective means to refine a surgery resident well-being program and to involve the residents themselves in that process.

Designing a Framework for Remote Cancer Care Through Community Co-design: Participatory Development Study.

BACKGROUND: Recent shifts to telemedicine and remote patient monitoring demonstrate the potential for new technology to transform health systems; yet, methods to design for inclusion and resilience are lacking. OBJECTIVE: The aim of this study is to design and implement a participatory framework to produce effective health care solutions through co-design with diverse stakeholders. METHODS: We developed a design framework to cocreate solutions to locally prioritized health and communication problems focused on cancer care. The framework is premised on the framing and discovery of problems through community engagement and lead-user innovation with the hypothesis that diversity and inclusion in the co-design process generate more innovative and resilient solutions. Discovery, design, and development were implemented through structured phases with design studios at various locations in urban and rural Kentucky, including Appalachia, each building from prior work. In the final design studio, working prototypes were developed and tested. Outputs were assessed using the System Usability Scale as well as semistructured user feedback. RESULTS: We co-designed, developed, and tested a mobile app (myPath) and service model for distress surveillance and cancer care coordination following the LAUNCH (Linking and Amplifying User-Centered Networks through Connected Health) framework. The problem of awareness, navigation, and communication through cancer care was selected by the community after framing areas for opportunity based on significant geographic disparities in cancer and health burden resource and broadband access. The codeveloped digital myPath app showed the highest perceived combined usability (mean 81.9, SD 15.2) compared with the current gold standard of distress management for patients with cancer, the paper-based National Comprehensive Cancer Network Distress Thermometer (mean 74.2, SD 15.8). Testing of the System Usability Scale subscales showed that the myPath app had significantly better usability than the paper Distress Thermometer (t63=2.611; P=.01), whereas learnability did not differ between the instruments (t63=-0.311; P=.76). Notable differences by patient and provider scoring and feedback were found. CONCLUSIONS: Participatory problem definition and community-based co-design, design-with methods, may produce more acceptable and effective solutions than traditional design-for approaches.

Designing a Pro-Equity HPV Vaccine Delivery Program for Girls Who Have Dropped Out of School: Community Perspectives From Uttar Pradesh, India.

India experiences a substantial burden of cervical cancer and accounts for nearly one third of cervical cancer deaths worldwide. While human papillomavirus (HPV) vaccines have been introduced subnationally in some states, HPV has not yet been rolled out nationally. Given the target age group, schools are the most common delivery channel for HPV vaccines, but this fails to account for local girls who never attended or no longer attend school. We conducted a qualitative, design-informed, community-based study conducted in Uttar Pradesh, India. We assessed facilitators and barriers among out-of-school girls and proposed program characteristics to inform the design of pro-equity HPV vaccine delivery programs for out-of-school girls. Programs should improve parental knowledge of the risk of cervical cancer, engage vaccinated girls as vaccine champions, utilize varied media options for low-literacy populations, and ensure that HPV vaccine services are accessible and flexible to accommodate out-of-school girls. In areas with poor or irregular school attendance among adolescent girls, HPV vaccine coverage will remain suboptimal until programs can effectively address their needs and reach this priority population. Our findings present a meaningful opportunity for program planners to purposefully design HPV vaccination programs according to these parameters, rather than modifying existing programs to include HPV vaccine. Adolescent girls, their parents, and other community members should be involved in program design to ensure that the program can effectively meet the needs of adolescent girls who are not in school.

Patients' lived experiences and recommendations for enhanced awareness and use of integrative oncology services in cancer care.

BACKGROUND: Consuming educational content, adhering to treatment plans and managing symptoms and side-effects can be overwhelming to new oncology patients. OBJECTIVE: The purpose of this study is to engage patients in conceptualization of enhanced clinic processes and digital health tools to support awareness and use of integrative oncology services. PATIENT INVOLVEMENT: We engaged patients in participatory design to understand lived experiences surrounding use of integrative oncology services during and after conventional cancer treatment. METHODS: Ten participatory design sessions were held with individual participants. Sessions began with patient story telling regarding diagnosis and paths to awareness and use of integrative oncology services. We then reviewed prototype mobile app screens to solicit feedback regarding digital health functionality to support patient navigation of symptom-alleviating options. RESULTS: Oncology patients are active participants in the management of symptoms and side effects. Patients who utilize yoga, acupuncture, and massage report a need for earlier patient education about these services. Patients express interest in digital health tools to match symptoms to options for relief, provide access to searchable information, and facilitate streamlined access to in-person and remote services. DISCUSSION: Patients co-produce wellbeing by seeking solutions to daily challenges and consuming educational content. Clinics can collaborate with patients to identify high priority needs and challenges. PRACTICAL VALUE: Active collaboration with patients is needed to identify unmet needs and guide development of clinic processes and digital health tools to enhance awareness and use of IO services in conventional cancer care. FUNDING: The principal investigator was supported by the U.S. Agency for Healthcare Research and Quality (AHRQ K12HS026370). The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ. The sponsor had no role in the study design, data collection, analysis, report writing, or decision to submit for publication.

Ethnography and user-centered design to inform context-driven implementation.

Despite pervasive findings pointing to its inextricable role in intervention implementation, context remains poorly understood in implementation science. Existing approaches for describing context (e.g., surveys, interviews) may be narrow in scope or superficial in their elicitation of contextual data. Thus, in-depth and multilevel approaches are needed to meaningfully describe the contexts into which interventions will be implemented. Moreover, many studies assess context without subsequently using contextual information to enhance implementation. To be useful for improving implementation, though, methods are needed to apply contextual information during implementation. In the case example presented in this paper, we embedded an ethnographic assessment of context within a user-centered design approach to describe implementation context and apply that information to promote implementation. We developed a patient-reported outcome measure-based clinical intervention to assess and address the pervasive unmet needs of young adults with cancer: the Needs Assessment & Service Bridge (NA-SB). In this paper, we describe the user-centered design process that we used to anticipate context modifications needed to deliver NA-SB and implementation strategies needed to facilitate its implementation. Our ethnographic contextual inquiry yielded a rich understanding of local implementation context and contextual variation across potential scale-up contexts. Other methods from user-centered design (i.e., translation tables and a design team prototyping workshop) allowed us to translate that information into specifications for NA-SB delivery and a plan for implementation. Embedding ethnographic methods within a user-centered design approach can help us to tailor interventions and implementation strategies to their contexts of use to promote implementation.

The field of implementation science studies how to better integrate research evidence into practice. To accomplish this integration, it is important to understand the contexts into which interventions are being implemented. For example, implementation may be influenced by contextual factors such as patient/provider beliefs about an intervention, budget constraints, leadership buy-in, an organization's readiness to change, and many others. Understanding these factors upfront can allow us to adapt interventions to better suit context (e.g., tailoring intervention content to patients' needs), change context to make it more ready for implementation (e.g., changing provider workflow to accommodate an intervention), and anticipate strategies that may be needed to implement an intervention (e.g., delivering training on the intervention to providers). To do this, the field of implementation science is in need of methods for assessing context and using that information to improve implementation. In this paper, we present several methods, including ethnography and methods from user-centered design, for using context to inform implementation efforts.