Patient and public co-creation of healthcare safety and healthcare system resilience: The case of COVID-19.

INTRODUCTION: Healthcare system resilience is a conceptual approach that seeks to explore how health services adapt and respond to variability in demand and resources. As has been witnessed since the beginning of the COVID-19 pandemic, healthcare services have undergone many reconfigurations. One understudied aspect of how the 'system' is able to adapt and respond is the contribution of key stakeholders-patients and families, and in the context of the pandemic, the general public as a whole. This study aimed to understand what people were doing during the first wave of the pandemic to protect the safety of their health, and the health of others from COVID-19, and the resilience of the healthcare system. METHODS: Social media (Twitter) was used as a method of recruitment due to its ability for social reach. Twenty-one participants took part in 57 semistructured interviews over three time points from June to September 2020. The included an initial interview and invitation to two follow-up interviews after 3 and 6 weeks. Interviews were conducted virtually using Zoom-an encrypted secure video conferencing software. A reflexive thematic analysis approach to analysis was used. RESULTS: Three themes, each with its own subthemes were identified in the analysis: (1) A 'new safety normal'; (2) Existing vulnerabilities and heightened safety and (3) Are we all in this together? CONCLUSION: This study found that the public had a role in supporting the resilience of healthcare services and systems during the first wave of the pandemic by adapting their behaviour to protect themselves and others, and to avoid overwhelming the National Health Service. People who had existing vulnerabilities were more likely to experience safety gaps in their care, and be required to step in to support their safety, despite it being more difficult for them to do so. It may be that the most vulnerable were previously required to do this extra work to support the safety of their care and that the pandemic has just illuminated this issue. Future research should explore existing vulnerabilities and inequalities, and the heightened safety consequences created by the pandemic. PATIENT AND PUBLIC CONTRIBUTION: The National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC), Patient and Public Involvement and Engagement Research Fellow and NIHR Yorkshire and Humber PSTRC Patient Involvement in Patient Safety theme lay leader are involved in the preparation of a lay version of the findings within this manuscript.

Patient public involvement (PPI) in health literacy research: Engagement of adults with literacy needs in the co-creation of a hospital-based health literacy plan.

BACKGROUND: People with literacy needs can experience many challenges in accessing, understanding and using health services and health information. Such challenges can adversely impact patient-provider interactions and ultimately, health outcomes. Healthcare providers need to be aware of health literacy (HL) to address the demands of healthcare systems, improve their interactions with communities and patients and promote patient engagement for improved health outcomes. METHODS: This paper reports on a process of patient and public involvement (PPI) with participants in an adult literacy programme acting as PPI contributors to identify priority areas for a local hospital HL action plan and to develop a protocol for a PPI process with other groups. A qualitative community-based participatory research study design informed by principles of PPI was undertaken, drawing on the tools of participatory and visual methods, open discussion and workshop format to facilitate a process of co-creation. Three workshops with six PPI contributors took place to identify issues to be included in the hospital action plan. PPI contributors identified issues and grouped these into priority areas using discussion and ranking procedures. RESULTS: Key areas prioritised for HL action by the PPI contributors were: verbal communication, emphasising the patient's right to understand, and improved understanding of medication use. These were incorporated into the action plan. The workshop format and process were deemed acceptable to the group and input on improvements will be incorporated into further work in this area. CONCLUSION: PPI acts as a lever in the knowledge translation process. Genuine engagement with service users can meaningfully contribute to relevant and sustainable changes to services as well as foster the empowerment of service users. PATIENT OR PUBLIC CONTRIBUTION: Members of the public with literacy needs actively participated in the co-creation of a HL action plan for a local hospital and in the development of a protocol for a patient and public process for HL research.

Adapting Patient and Public Involvement processes in response to the Covid-19 pandemic.

BACKGROUND: The COVID-19 pandemic brought rapid and major changes to research, and those wishing to carry out Patient and Public Involvement (PPI) activities faced challenges, such as restrictions on movement and contact, illness, bereavement and risks to potential participants. Some researchers moved PPI to online settings during this time but remote consultations raise, as well as address, a number of challenges. It is important to learn from PPI undertaken in this period as face-to-face consultation may no longer be the dominant method for PPI. METHODS: UK stay-at-home measures announced in March 2020 necessitated immediate revisions to the intended face-to-face methods of PPI consultation for the ESORT Study, which evaluated emergency surgery for patients with common acute conditions. PPI plans and methods were modified to all components being online. We describe and reflect on: initial plans and adaptation; recruitment; training and preparation; implementation, contextualisation and interpretation. Through first-hand accounts we show how the PPI processes were developed, experienced and viewed by different partners in the process. DISCUSSION AND CONCLUSIONS: While concerns have been expressed about the possible limiting effects of forgoing face-to-face contact with PPI partners, we found important benefits from the altered dynamic of the online PPI environment. There were increased opportunities for participation which might encourage the involvement of a broader demographic, and unexpected benefits in that the online platform seemed to have a 'democratising' effect on the meetings, to the benefit of the PPI processes and outcomes. Other studies may however find that their particular research context raises particular challenges for the use of online methods, especially in relation to representation and inclusion, as new barriers to participation may be raised. It is important that methodological challenges are addressed, and researchers provide detailed examples of novel methods for discussion and empirical study. PATIENT AND PUBLIC CONTRIBUTION: We report a process which involved people with lived experience of emergency conditions and members of the public. A patient member was involved in the design and implementation, and two patients with lived experience contributed to the manuscript.

Intervention development of 'Diabetes Together' using the person-based approach: a couples-focused intervention to support self-management of type 2 diabetes in South Africa.

OBJECTIVES: Type 2 diabetes (T2D) is a growing concern in South Africa, where many find self-management challenging. Behaviour-change health interventions are enhanced by involving partners of patients. We aimed to develop a couples-focused intervention to improve self-management of T2D among adults in South Africa. DESIGN: We used the person-based approach (PBA): synthesising evidence from existing interventions; background research; theory; and primary qualitative interviews with 10 couples to ascertain barriers and facilitators to self-management. This evidence was used to formulate guiding principles that directed the intervention design. We then prototyped the intervention workshop material, shared it with our public and patient involvement group and ran iterative co-discovery think-aloud sessions with nine couples. Feedback was rapidly analysed and changes formulated to improve the intervention, optimising its acceptability and maximising its potential efficacy. SETTING: We recruited couples using public-sector health services in the area of Cape Town, South Africa, during 2020-2021. PARTICIPANTS: The 38 participants were couples where one person had T2D. INTERVENTION: We developed the 'Diabetes Together' intervention to support self-management of T2D among couples in South Africa, focussing on: improved communication and shared appraisal of T2D; identifying opportunities for better self-management; and support from partners. Diabetes Together combined eight informational and two skills-building sections over two workshops. RESULTS: Our guiding principles included: providing equal information on T2D to partners; improving couples' communication; shared goal-setting; discussion of diabetes fears; discussing couples' roles in diabetes self-management; and supporting couples' autonomy to identify and prioritise diabetes self-management strategies.Participants viewing Diabetes Together valued the couples-focus of the intervention, especially communication. Feedback resulted in several improvements throughout the intervention, for example, addressing health concerns and tailoring to the setting. CONCLUSIONS: Using the PBA, our intervention was developed and tailored to our target audience. Our next step is to pilot the workshops' feasibility and acceptability.

Challenges in Recruitment and Retention: Leveraging Health-Related Antecedents and Information Carrier Factors to Improve Patient Participation in Pancreatic Cancer Research-A Review Article.

ABSTRACT: Advancements in pancreatic ductal adenocarcinoma (PDAC) prevention, diagnosis, and treatment rely on representative and robust clinical trial participation. Given the severity of PDAC, along with the lack of effective early detection approaches, the need for accessible screening tools and new treatments is dire. Unfortunately, enrollment barriers often result in low participant accrual rates for PDAC studies and illustrate the challenging terrain researchers are facing. Research participation along with access to preventative care has been further impacted by the coronavirus disease 2019 pandemic. In this review, we use the Comprehensive Model for Information Seeking to discuss underexplored factors that influence patient participation in clinical studies. Adequate staffing, flexible scheduling, effective patient and physician communication, and culturally responsive messaging, along with the use of telehealth, can support enrollment objectives. Clinical research studies are a key component of health care, informing medical advancements, and improving outcomes. By leveraging health-related antecedents and information carrier factors, researchers can more effectively address barriers to participation and implement potential evidence-based mitigating strategies. While this work focuses on the PDAC research context, the lessons delineated here are applicable to the wider cancer research setting.

COVID-19 Public Health Measures and Patient and Public Involvement in Health and Social Care Research: An Umbrella Review.

An umbrella review of previously published systematic reviews was conducted to determine the nature and extent of the patient and public involvement (PPI) in COVID-19 health and social care research and identify how PPI has been used to develop public health measures (PHM). In recent years, there has been a growing emphasis on PPI in research as it offers alternative perspectives and insight into the needs of healthcare users to improve the quality and relevance of research. In January 2022, nine databases were searched from 2020-2022, and records were filtered to identify peer-reviewed articles published in English. From a total of 1437 unique records, 54 full-text articles were initially evaluated, and six articles met the inclusion criteria. The included studies suggest that PHM should be attuned to communities within a sociocultural context. Based on the evidence included, it is evident that PPI in COVID-19-related research is varied. The existing evidence includes written feedback, conversations with stakeholders, and working groups/task forces. An inconsistent evidence base exists in the application and use of PPI in PHM. Successful mitigation efforts must be community specific while making PPI an integral component of shared decision-making.

The Patient Activation Measure (PAM) and the pandemic: Predictors of patient activation among Australian health consumers during the COVID-19 pandemic.

BACKGROUND: Preventative healthcare is crucial for improving individual patient outcomes and is integral to sustainable health systems. The effectiveness of prevention programs is enhanced by activated populations who are capable of managing their own health and are proactive to keep themselves well. However, little is known about the level of activation among people drawn from general populations. We used the Patient Activation Measure (PAM) to address this knowledge gap. METHODS: A representative, population-based survey of Australian adults was conducted in October 2021 during the Delta strain outbreak of the COVID-19 pandemic. Comprehensive demographic information was collected, and the participants completed the Kessler-6 psychological distress scale (K6) and PAM. Multinomial and binomial logistic regression analyses were performed to determine the effect of demographic factors on PAM scores, which are categorised into four levels: 1-participants disengaged with their health; 2-becoming aware of how to manage their health; 3-acting on their health; and 4-engaging with preventative healthcare and advocating for themselves. RESULTS: Of 5100 participants, 7.8% scored at PAM level 1; 13.7% level 2, 45.3% level 3, and 33.2% level 4. The mean score was 66.1, corresponding to PAM level 3. More than half of the participants (59.2%) reported having one or more chronic conditions. Respondents aged 18 to 24 years old were twice as likely to score PAM level 1 compared with people aged 25-44 (p < .001) or people aged over 65 years (p < .05). Speaking a language other than English at home was significantly associated with having low PAM (p < .05). Greater psychological distress scores (K6) were significantly predictive of low PAM scores (p < .001). CONCLUSION: Overall, Australian adults showed high levels of patient activation in 2021. People with lower incomes, of younger age, and those experiencing psychological distress were more likely to have low activation. Understanding the level of activation enables targeting sociodemographic groups for extra support to increase the capacity to engage in prevention activities. Conducted during the COVID-19 pandemic, our study provides a baseline for comparison as we move out of the pandemic and associated restrictions and lockdowns. PATIENT OR PUBLIC CONTRIBUTION: The study and survey questions were co-designed with consumer researchers from the Consumers Health Forum of Australia (CHF) as equal partners. Researchers from CHF were involved in the analysis of data and production of all publications using data from the consumer sentiment survey.

Adolescents with chronic conditions: Engagement with children's mental health systems during the Covid-19 pandemic.

PURPOSE: The Covid-19 pandemic contributed to adverse adolescent mental health outcomes globally. Adolescents with chronic conditions have four times the odds of self-harm than peers. Little evidence exists to guide pediatric nurses on how to engage this vulnerable population with mental health support as the pandemic continues. In adults with chronic conditions, positive health assets (health access literacy, health self-efficacy, and emotional well-being) are directly related to improved patient engagement. The objective of this study was to gain a deeper understanding of engagement with mental health supports in adolescents with chronic conditions to inform practice. DESIGN AND METHODS: Using mixed methods, we surveyed and interviewed adolescents with chronic conditions aged 10-20 years. Random sampling was applied to avoid bias. Valid and reliable scales were used to measure health access literacy, health self-efficacy, and emotional well-being. Textual data were collected using a semistructured interview guide. Integrated data analysis was conducted using structural equation models and interpretive phenomenology. RESULTS: One hundred fifty-four participants provided numerical data and 17 participants provided textual data (mean age 15.5 years; 56% female, 5.8% agender; 56% White; 16.9% Black or African American, 4.5% Asian; 51.9% Hispanic or Latinx; 23.4% LGBTQ+). The structural model was an acceptable fit for the data (comparative fit index [CFI] = 0.97, Tucker-Lewis index [TLI] = 0.95). Participants reported higher levels of health access literacy (M = 3.88, SD = 0.848) than health self-efficacy (M = 2.98, SD = 0.646), and engagement (M = 1.78, SD = 1.71). Health access literacy predicted emotional well-being (ß = .33, p < .001, 95% confidence interval [CI] [.20, .50]) and health self-efficacy (ß = .52, p < .001, 95% CI [0.42, .062]). Emotional well-being positively predicted health self-efficacy (ß = .21, p < .003, 90% CI [0.10, 0.033]). Health self-efficacy predicted engagement (ß = .20, p < .01, 90% CI [0.07, 0.034]). Participants reported not engaging until "it was really, really bad" citing fear, stigma, and lack of connectedness with providers as barriers. PRACTICE IMPLICATIONS: Regardless of health access literacy and health self-efficacy, adolescents with chronic conditions may not engage until crisis levels. Pediatric nurses can aim to engage with this vulnerable population proactively.

Rapid response nursing triage outcomes for COVID-19: factors associated with patient's participation in triage recommendations.

BACKGROUND: COVID-19 is an ongoing global health crisis with prevention and treatment recommendations rapidly changing. Rapid response telephone triage and advice services are critical in providing timely care during pandemics. Understanding patient participation with triage recommendations and factors associated with patient participation can assist in developing sensitive and timely interventions for receiving the treatment to prevent adverse health effects of COVID-19. METHODS: This cohort study aimed to assess patient participation (percentage of patients who followed nursing triage suggestions from the COVID hotline) and identify factors associated with patient participation in four quarterly electronic health records from March 2020 to March 2021 (Phase 1: 14 March 2020-6 June 2020; Phase 2: 17 June 2020-16 September 2020; Phase 3: 17 September 2020-16 December 2020; Phase 4: 17 December 2020-16 March 2021). All callers who provided their symptoms (including asymptomatic with exposure to COVID) and received nursing triage were included in the study. Factors associated with patient participation were identified using multivariable logistic regression analyses, including demographic variables, comorbidity variables, health behaviors, and COVID-19-related symptoms. RESULTS: The aggregated data included 9849 encounters/calls from 9021 unique participants. Results indicated: (1) 72.5% of patient participation rate; (2) participants advised to seek emergency department care had the lowest patient participation rate (43.4%); (3) patient participation was associated with older age, a lower comorbidity index, a lack of unexplained muscle aches, and respiratory symptoms. The absence of respiratory symptoms was the only factor significantly associated with patient participation in all four phases (OR = 0.75, 0.60, 0.64, 0.52, respectively). Older age was associated with higher patient participation in three out of four phases (OR = 1.01-1.02), and a lower Charlson comorbidity index was associated with higher patient participation in phase 3 and phase 4 (OR = 0.83, 0.88). CONCLUSION: Public participation in nursing triage during the COVID pandemic requires attention. This study supports using a nurse-led telehealth intervention and reveals crucial factors associated with patient participation. It highlighted the importance of timely follow-up in high-risk groups and the benefit of a telehealth intervention led by nurses serving as healthcare navigators during the COVID-19 pandemic.

Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial.

Importance: Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae. Objective: To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery. Design, Setting, and Participants: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic. Interventions: The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed. Main Outcomes and Measures: Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively. Results: In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care. Conclusions and Relevance: This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care. Trial Registration: trialregister.nl Identifier: NTR5947.

A qualitative study exploring how patient engagement activities were sustained or adapted in Canadian healthcare organizations during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic caused disruptions across healthcare systems globally exposing the precarious state of patient engagement across all levels of healthcare. While evidence is emerging to describe how engagement was affected across various settings, insights about how some organizations at the policy and practice level of healthcare were able to sustain or adapt patient engagement activities is lacking. OBJECTIVE: This paper addresses the following research question: "How were healthcare, government, and patient partner organizations able to sustain or adapt patient engagement activities during the COVID-19 pandemic?" METHODS: A qualitative descriptive study was conducted to understand how patient engagement activities were maintained or adapted in a variety of healthcare, government, and patient partner organizations in Canada throughout the pandemic. This analysis was part of a larger qualitative, multiple case study where one-to-one interviews were conducted with organizational leaders, managers and patient partners. RESULTS: The following themes were identified as key aspects of maintaining or adapting patient engagement activities: 1) having an embedded organizational culture of patient engagement; 2) adapting patient engagement activities to focus on COVID-19 response efforts; 3) having patient partners who exercised leadership and advocacy to support patient care and experiences during the pandemic; and 4) leveraging virtual technology as a communication tool to engage patient partners. CONCLUSION: This paper highlights important insights that may be useful to other health care organizations on how to sustain or adapt patient engagement activities during a healthcare crisis. Having patient engagement embedded within an organization's culture supported by, but not limited to, infrastructure, resources, investments in dedicated staff and patient partner leadership, and communication strategies and tools enabled continued patient engagement activities during the pandemic.

Characteristics of Emergency Medicine Specimen Bank Participants Compared to the Overall Emergency Department Population.

INTRODUCTION: Biorepositories lack diversity both demographically and with regard to the clinical complaints of patients enrolled. The Emergency Medicine Specimen Bank (EMSB) seeks to enroll a diverse cohort of patients for discovery research in acute care conditions. Our objective in this study was to determine the differences in demographics and clinical complaints between participants in the EMSB and the overall emergency department (ED) population. METHODS: This was a retrospective analysis of participants of the EMSB and the entire UCHealth at University of Colorado Anschutz Medical Center (UCHealth AMC) ED population across three periods: peri-EMSB; post-EMSB; and COVID-19. We compared patients consented to the EMSB to the entire ED population to determine differences in age, gender, ethnicity, race, clinical complaints, and severity of illness. We used chi-square tests to compare categorical variables and the Elixhauser Comorbidity Index to determine differences in the severity of illness between the groups. RESULTS: Between February 5, 2018-January 29, 2022, there were 141,670 consented encounters in the EMSB, representing 40,740 unique patients and over 13,000 blood samples collected. In that same time, the ED saw approximately 188,402 unique patients for 387,590 encounters. The EMSB had significantly higher rates of participation from the following: patients 18-59 years old (80.3% vs 77.7%); White patients (52.3% vs 47.8%), and women (54.8% vs 51.1%) compared to the overall ED population. The EMSB had lower rates of participation from patients ≥70 years, Hispanic patients, Asian patients, and men. The EMSB population had higher mean comorbidity scores. During the six months after Colorado's first COVID-19 case, the rate of consented patients and samples collected increased. The odds of consent during the COVID-19 study period were 1.32 (95% CI 1.26-1.39), and the odds of sample capture were 2.19 (95% CI 2.0-2.41). CONCLUSION: The EMSB is representative of the overall ED population for most demographics and clinical complaints.

A framework for implementing Patient and Public Involvement in mental health research: The PATHWAY research programme benchmarked against NIHR standards.

BACKGROUND: Patient and Public Involvement (PPI) in research has become a key component recommended by research commissioners, grant award bodies and specified in government policies. Despite the increased call for PPI, few studies have demonstrated how to implement PPI within large-scale research studies. OBJECTIVE: The aim of the current study was to provide a case example of the implementation of a patient advisory group in a large-scale mental health research programme (PATHWAY) and to benchmark this against UK standards. METHOD: A PPI group was incorporated throughout the PATHWAY research programme, from grant development to dissemination. The group attended regular meetings and supported participant recruitment, evaluated patient-facing documents, supported the piloting of the research intervention and co-developed the dissemination and impact strategy. The implementation of PPI throughout the project was benchmarked against the UK standards for PPI. RESULTS: The inclusion of PPI in the PATHWAY project provided tangible changes to the research project (i.e., improving study documents, co-developing dissemination materials) but also proved to be a beneficial experience to PPI members through the development of new skills and the opportunity to provide a patient voice in research. We show how PPI was involved across seven study phases and provide examples of implementation of the six UK standards. The study did not include PPI in data analysis but met all the UK standards for PPI. Challenges regarding practical components (i.e., meeting frequency, language use), increasing diversity and PPI members' knowledge of research were highlighted as areas for further improvement. CONCLUSIONS: We provide a case example of how PPI can be implemented throughout a research lifecycle and we note the barriers faced and make suggestions for PPI in future implementation and research. PATIENT AND PUBLIC CONTRIBUTION: PPI members were involved throughout the lifecycle of the research programme. The PPI lead was a co-author on the manuscript and contributed to report writing.

The art of shared decision making.

ABSTRACT: Now more than ever, we know that there is uncertainty in medicine. Over the past 2 years, we have witnessed the evolution of knowledge that occurs in medicine and how this informs medical recommendations. Similarly, we have learned that patients have varying levels of risk tolerance, goals, and values. Although this is not a new reality, the COVID-19 pandemic has put it on display. Shared decision making is a tool for clinicians to use that recognizes this reality, honors the individuality of each patient, and guides us to the best decision for each patient.

Co-developing patient and family engagement indicators for health system improvement with healthcare system stakeholders: a consensus study.

OBJECTIVE: To develop a set of patient and family engagement indicators (PFE-Is) for measuring engagement in health system improvement for a Canadian provincial health delivery system through an evidence-based consensus approach. DESIGN: This mixed-method, multiphase project included: (1) identification of existing measures of patient and family engagement through a review of the literature and consultations with a diverse provincial council of patients, caregivers, community members and researchers. The Public and Patient Engagement Evaluation Tool (PPEET) was selected; (2) consultations on relevance, acceptability and importance with patient and family advisors, and staff members of Alberta Health Services' Strategic Clinical Networks. This phase included surveys and one-on-one semi-structured interviews aimed to further explore the use of PPEET in this context. Findings from the survey and interviews informed the development of PFE-Is; (3) a Delphi consensus process using a modified RAND/UCLA Appropriateness Method to identify and refine a core set of PFE-Is. PARTICIPANTS: The consensus panel consisted of patients, family members, community representatives, clinicians, researchers and healthcare leadership. RESULTS: From an initial list of 33 evidence-based PFE-Is identified, the consensus process yielded 18 final indicators. These PFE-Is were grouped into seven themes: communication, comfort to contribute, support needed for engagement, impact and influence of engagement initiative, diversity of perspectives, respectful engagement, and working together indicators. CONCLUSIONS: This group of final patient, family and health system leaders informed indicators can be used to measure and evaluate meaningful engagement in health research and system transformation. The use of these metrics can help to improve the quality of patient and family engagement to drive health research and system transformation.

Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial.

INTRODUCTION: Socioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may reduce health disparities by addressing barriers to patient engagement in decision-making that disproportionately impact socioeconomically disadvantaged patients. In this trial, we test the impact of a decision aid on increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making. METHODS AND ANALYSIS: This multisite randomised trial is conducted through 10 surgical clinics within the National Cancer Institute Community Oncology Research Program (NCORP). We plan a stepped-wedge design with clinics randomised to the time of transition from usual care to the decision aid arm. Study participants are female patients, aged ≥18 years, with newly diagnosed stage 0-III breast cancer who are planning breast surgery. Data collection includes a baseline surgeon survey, baseline patient survey, audio-recording of the surgeon-patient consultation, a follow-up patient survey and medical record data review. Interviews and focus groups are conducted with a subset of patients, surgeons and clinic stakeholders. The effectiveness of the decision aid at increasing patient engagement (primary outcome) is evaluated using generalised linear mixed-effects models. The extent to which the effect of the decision aid intervention on patient engagement is mediated through the mitigation of barriers is tested in joint linear structural equation models. Qualitative interviews explore how barriers impact engagement, especially for socioeconomically disadvantaged women. ETHICS AND DISSEMINATION: This protocol has been approved by the National Cancer Institute Central Institutional Review Board, and Certificate of Confidentiality has been obtained. We plan to disseminate the findings through journal publications and national meetings, including the NCORP network. Our findings will advance the science of medical decision-making with the potential to reduce socioeconomic health disparities. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03766009).

Integrating a Patient Engagement App into an Electronic Health Record-Enabled Workflow Using Interoperability Standards.

BACKGROUND: Patient use of mobile health applications is increasing. To promote patient-centered care, data from these apps must be integrated into clinician workflows within the electronic health record (EHR). Health Level 7 Fast Healthcare Interoperability Resources (FHIR) offers a standards-based application programming interface (API) that may support such integration. OBJECTIVE: We aimed to use interoperability standards to integrate a patient mobile application (coronavirus 2019 [COVID-19] Tracker) with an EHR. The COVID-19 Tracker engages patients by sending introductory and reminder text messages, collecting vital signs and symptom data from COVID-19 patients, and providing actionable guidance if concerning issues are identified. This case report explored the use of FHIR APIs to integrate the app into EHR-enabled clinical workflows. METHODS: The authors used notes from project meetings and from semistructured discussions among the application development team to track the design and implementation processes. Seven points of integration between the application and the EHR were identified, and approaches using FHIR to perform these integrations were delineated. RESULTS: Although this clinical decision support integration project benefited from its standards-based approach, many challenges were encountered. These were due to (1) partial implementation of the FHIR standard in the EHR, particularly, components needed for patient engagement applications; (2) limited experience with the adoption of FHIR standards; and (3) gaps in the current FHIR standard. Alternative approaches, often not based on interoperability standards, were developed to overcome these limitations. CONCLUSION: Despite the challenges encountered due to the early stages of FHIR development and adoption, FHIR standards provide a promising mechanism for overcoming longstanding barriers and facilitating the integration of patient engagement apps with EHRs. To accelerate the integration of apps into clinical workflows, additional components of the FHIR standard must be implemented within the EHR and other clinical systems. Continued expansion of available FHIR resources will help with tighter workflow integration.