UNASSIGNED: Elevating Voices, Addressing Depression, Toxic Stress and Equity (EleVATE) is a group prenatal care (GC) model designed to improve pregnancy outcomes and promote health equity for Black birthing people. This article outlines the foundational community-engaged process to develop EleVATE GC and pilot study results.
UNASSIGNED: We used community-based participatory research principles and the Ferguson Commission Report to guide creation of EleVATE GC. The intervention, designed by and for Black birthing people, centers trauma-informed care, antiracism, and integrates behavioral health strategies into group prenatal care to address unmet mental health needs. Using a convenience sample of patients seeking care at one of three safety-net health care sites, we compared preterm birth, small for gestational age, depression scores, and other pregnancy outcomes between patients in individual care (IC), CenteringPregnancy™ (CP), and EleVATE GC.
UNASSIGNED: Forty-eight patients enrolled in the study (n=11 IC; n=14 CP; n=23 EleVATE GC) and 86% self-identified as Black. Patients participating in group prenatal care (EleVATE GC or CP) were significantly less likely to experience a preterm birth <34 weeks. Rates of small for gestational age, preterm birth <37 weeks, depression scores, and other pregnancy outcomes were similar across groups. Participants in CP and EleVATE GC were more likely to attend their postpartum visit and breastfeed at hospital discharge than those in IC.
UNASSIGNED: Our findings model a systematic approach to design a feasible, patient-centered, community-based, trauma-informed, antiracist intervention. Further study is needed to determine whether EleVATE GC improves perinatal outcomes and promotes health equity.

Background: Overactive bladder (OAB) is a symptom-defined disorder. A range of instruments are available for assessing OAB symptom bother, urinary urgency and the effects of symptoms on health-related quality of life (HRQoL), but few have been specifically designed and validated for this condition. HRQoL instruments should capture the concepts that are most relevant to patients. To our knowledge, there is no existing published conceptual framework for OAB. Objectives: We performed a qualitative study to explore the impact of symptoms of OAB on affected patients and to develop a conceptual framework for OAB. Methods: Patients diagnosed with OAB living in the United Kingdom were interviewed on the telephone by a trained psychologist using an interview discussion guide. Interview transcripts were analyzed thematically by two psychologists. Data collection and analysis was completed when data saturation, i.e. when little or no new information was obtained, was achieved. Results: A total of 30 patients were interviewed. Fifteen patients (50%) had urge incontinence (i.e. OAB-wet). Interview data showed that OAB affected role functioning, sleep quality, social functioning, and emotional/mental functioning. In addition, patients often adopted non-medical coping strategies to manage their symptoms (e.g. planning activities). Factors which affected more than 50% of patients were going for a short walk, waking up at night, travelling/holidays, socializing/going out, embarrassment/shame, need to plan activities, and restriction of places visited. More patients with OAB-wet reported impairment of social and emotional/mental functioning than patients with OAB-dry. A conceptual framework for adults with OAB depicting the relationships between OAB concepts (or outcomes) was developed. Conclusions: OAB has a profound effect on patient HRQoL and negatively affects a broad range of functions, including daily and work activities, leisure and social activities, psychological well-being, and sleep capacity. The conceptual framework emerging from this study supports the utilization of existing disease-specific HRQoL instruments, but identifies that work-related effects, which are relevant for OAB patients, are missing from currently available measures.

BACKGROUND: Limited evidence exists about which patient and stakeholder engagement practices support or hinder study teams as they negotiate different viewpoints in decisions about the design and conduct of patient-centered outcomes research.
METHODS: We applied a multiple-embedded descriptive case study design for six studies funded by the Patient-Centered Outcomes Research Institute (PCORI). We interviewed 32 researchers and stakeholder partners, including patients, caregivers and clinicians, and reviewed documents related to each study (e.g., publications, and progress reports submitted to PCORI).
RESULTS: Overall, researchers reported that incorporating different viewpoints was a strength or opportunity to learn rather than something to be avoided or dreaded. Across cases, different viewpoints and priorities, often related to ethical or pragmatic considerations, emerged between researchers and stakeholders, between stakeholder groups (e.g., patients and clinicians) or within groups (e.g., amongst researchers). Examples of navigating different viewpoints arose across study phases. The length of time to resolve issues depended on how strongly people disagreed and the perceived importance or impact of decisions on the study. All cases used collaborative decision-making approaches, often described as consensus, throughout the study. Interviewees described consensus as using negotiation, compromise or working towards an agreeable decision. To encourage consensus, cases actively facilitated group discussions with an openness to diverse opinions, remained flexible and open to trying new things, referenced a ground rule or common goal and delegated decisions to partners or smaller workgroups. When viewpoints were not easily resolved, cases used different approaches to reach final decisions while maintaining relationships with partners, such as elevating decisions to leadership or agreeing to test out an approach. No one engagement structure (e.g., advisory group, coinvestigator) stood out as better able to manage different viewpoints. Teams adjusted engagement structures and behaviours to facilitate an overall culture of inclusion and respect. Partners acknowledged the intentional efforts of researchers to incorporate their perspectives, navigate challenges and communicate the value of partner input.
CONCLUSIONS: By using collaborative decision-making in the early stages and throughout the study, researchers built trust with partners so that when decisions were difficult to resolve, partners still felt listened to and that their input mattered.
UNASSIGNED: Members of the PCORI Patient Engagement Advisory Panel in 2019-2020 provided input into the design of the study, including the research questions and approaches to data collection and analysis.

UNASSIGNED: Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice.
UNASSIGNED: This qualitative study convened eight virtual focus groups, four with investigators and four with patient partners from research studies funded by the Patient-Centered Outcomes Research Institute (PCORI). In total, 23 investigators and 20 partners participated. We explored perspectives, experiences, influences, and recommendations related to aggregate results return.
UNASSIGNED: Focus group participants described the ethical importance of returning aggregate results, as well as the benefits to study participants. They also noted important impediments to results return, emphasizing IRB and logistical challenges and describing a lack of support for the practice both on the part of institutions and the field at large. Participants highlighted the value of patients and caregivers\' perspectives and contributions to results return, which focused on returning the most relevant findings through effective channels and formats. They further emphasized the importance of planning and identified resources that could support results return.
UNASSIGNED: Researchers, funders, and the field can better facilitate results return by promoting standardized processes in research, such as the earmarking of funds for results return and inclusion of results returns milestones in research plans. More intentional policies, infrastructures, and resources that support results return may lead to more widespread return of study results to those who make these studies possible.

Anxiety disorders are a common underlying cause of symptoms among low-risk chest pain patients evaluated in the emergency department setting. However, anxiety is often undiagnosed and undertreated in any setting, and causes considerable functional impairment to work, family, and social life.
The Patient-Centered Treatment of Anxiety after Low-Risk Chest Pain in the Emergency Room (PACER) study is a pragmatic randomized trial to test the comparative effectiveness of existing anxiety treatments of graduated intensities and determine what options work best for patient subgroups based on anxiety severity and other comorbidities.
The PACER trial will enroll 375 emergency department patients with low-risk chest pain and anxiety (GAD-7 score ≥ 8) and randomize them to either: 1) referral to primary care with enhanced care coordination, 2) online self-administered cognitive behavioral therapy with guided peer support, or 3) therapist-administered cognitive behavior therapy. Outcomes include anxiety symptoms (primary) as well as physical symptom burden, depression symptoms, functional impairment, ED recidivism, and occurrence of major adverse cardiac events. Statistical analyses will be conducted primarily using linear mixed models to perform a repeated measures analysis of patient-reported outcomes, assessed at 3, 6, 9, and 12-month follow-ups.
PACER is an innovative and pragmatic clinical trial that will compare the effectiveness of several evidence-based telecare-delivered treatments for anxiety. Results have the potential to inform clinical guidelines for evaluation and management of low-risk chest pain patients and promote adoption of findings in ED departments across the country.

Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement.
To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19?
We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants\' experiences with the impact of COVID-19 on research engagement.
Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript.
We used a content analysis approach and identified the main themes using an inductive process.
Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity.
COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement.
Clinicaltrials.gov NCT02722382.

Engaging patients and other stakeholders as partners in research offers promise in improving the relevance and usefulness of research findings.
To explore the influence and impact of patient and other stakeholder engagement on the planning and conduct of comparative effectiveness research studies.
Qualitative study with virtual, hour-long semi-structured interviews.
Fifty-eight researchers and fifty-one partners from a diverse purposeful sample of fifty-eight studies funded by the Patient-Centered Outcomes Research Institute (PCORI).
Content and thematic analysis of interview data.
Described as an integral, long-term part of the research process, engagement influenced all aspects of the design and execution of studies. Partner influence was also dynamic and iterative, taking different forms over the course of the study. Across studies, we identified 387 discrete examples of influence and classified each as one of five types of influence, derived inductively from the interview data: co-producing, redirecting, refining, confirming, and limited. Most projects exhibited multiple types of influence, with 50 researchers and 41 partners reporting two or more types of influence within a project. Of the 387 examples of stakeholder influence, 306 had at least one reported impact on the study. Such impacts included changes to reflect the needs and preferences of patients or clinicians, as well as impacts on study feasibility, study quality, engagement scope or quality, and study relevance. Both researchers and partners identified multiple types of impact within projects, with 42 researchers and 38 partners reporting two or more types within a project. Because of these observable impacts, researchers and partners described engagement as worthwhile.
Findings provide insights for funders and institutions supporting engagement, measurement efforts, and clinical researchers aiming to conduct engaged research and observe similar influences and impacts in their own studies.

BACKGROUND: Although short-term blood glucose levels and variability are thought to underlie diminished function and emotional well-being in people with type 1 diabetes (T1D), these relationships are poorly understood. The Function and Emotion in Everyday Life with T1D (FEEL-T1D) study focuses on investigating these short-term dynamic relationships among blood glucose levels, functional ability, and emotional well-being in adults with T1D.
OBJECTIVE: The aim of this study is to present the FEEL-T1D study design, methods, and study progress to date, including adaptations necessitated by the COVID-19 pandemic to implement the study fully remotely.
METHODS: The FEEL-T1D study will recruit 200 adults with T1D in the age range of 18-75 years. Data collection includes a comprehensive survey battery, along with 14 days of intensive longitudinal data using blinded continuous glucose monitoring, ecological momentary assessments, ambulatory cognitive tasks, and accelerometers. All study procedures are conducted remotely by mailing the study equipment and by using videoconferencing for study visits.
RESULTS: The study received institutional review board approval in January 2019 and was funded in April 2019. Data collection began in June 2020 and is projected to end in December 2021. As of June 2021, after 12 months of recruitment, 124 participants have enrolled in the FEEL-T1D study. Approximately 87.6% (7082/8087) of ecological momentary assessment surveys have been completed with minimal missing data, and 82.0% (82/100) of the participants provided concurrent continuous glucose monitoring data, ecological momentary assessment data, and accelerometer data for at least 10 of the 14 days of data collection.
CONCLUSIONS: Thus far, our reconfiguration of the FEEL-T1D protocol to be implemented remotely during the COVID-19 pandemic has been a success. The FEEL-T1D study will elucidate the dynamic relationships among blood glucose levels, emotional well-being, cognitive function, and participation in daily activities. In doing so, it will pave the way for innovative just-in-time interventions and produce actionable insights to facilitate tailoring of diabetes treatments to optimize the function and well-being of individuals with T1D.
UNASSIGNED: DERR1-10.2196/30901.

BACKGROUND: Cystic fibrosis (CF) is a rare, life-shortening, multiorgan disease, the treatment of which has seen significant increases in the life expectancy of those with CF. Many advances in CF care are thanks to the dedicated and active participation of people with CF as research participants. Unfortunately, most CF research teams still do not fully partner with people with CF or their caregivers.
OBJECTIVE: The aim of this study was to determine the interest, knowledge gaps, and desired format for patient-centered outcomes research (PCOR) training in the CF community.
METHODS: We surveyed patients, caregivers, researchers, research staff, and diverse health care providers via list servers and social media outreach about their knowledge of, experience with, and preferences for PCOR training components. We followed the survey with 3 small-group discussion sessions with 22 participants who completed the survey to establish consensus and prioritize key learning components of a PCOR training program. We summarized results using descriptive statistics.
RESULTS: A total of 170 participants completed the survey (patients/caregivers: 96/170, 56.5%; researchers/health care providers: 74/170, 43.5%). Among providers, 26% (19/74) were physicians/advanced practice providers, 20% (15/74) were nurses, and 54% (40/74) were from other disciplines. Among all participants, 86.5% (147/170) expressed interest in learning about PCOR, although training topics and training format differed between the patient/caregiver and researcher/health care provider groups. Before participating in PCOR, patients/caregivers wanted to understand more about expectations of them as partners on PCOR research teams (82/96, 85%). Meanwhile, researchers/health care providers desired information on how to include outcomes important to patients/caregivers (55/74, 74%) and the quality and impact of PCOR research (52/74, 70% and 51/74, 69%, respectively). Patients/caregivers were most interested in learning about the time commitment as a PCOR team member (75/96, 78%). Researchers/health care providers wanted to receive training about how to establish trust (47/74, 64%) and maintain confidentiality (47/74, 64%) when including patient or caregiver partners on the PCOR team. During follow-up discussions, participants emphasized the importance of addressing the traditional patient/caregiver and researchers/health care provider hierarchy by teaching about transparency, appreciation, creating a common language between the groups, and providing specific training on \"how\" to do PCOR.
CONCLUSIONS: Our findings suggest CF community members are interested in PCOR. A high-quality training program would fill a current deficit in methodological research. This assessment identified the topics and formats desired and can be used to develop targeted training to enhance meaningful PCOR in CF.

BACKGROUND: Patient-centered outcomes research (PCOR) engages patients as partners in research and focuses on questions and outcomes that are important to patients. The COVID-19 pandemic has forced PCOR teams to engage through web-based platforms rather than in person. Similarly, virtual engagement is the only safe alternative for members of the cystic fibrosis (CF) community, who spend their lives following strict infection control guidelines and are already restricted from in-person interactions. In the absence of universal best practices, the CF community has developed its own guidelines to help PCOR teams engage through web-based platforms.
OBJECTIVE: This study aimed to identify the important attributes, facilitators, and barriers to teams when selecting web-based platforms.
METHODS: We conducted semistructured interviews with CF community members, nonprofit stakeholders, and researchers to obtain information regarding their experience with using web-based platforms, including the effectiveness and efficiency of these platforms and their satisfaction with and confidence while using each platform. Interviews conducted via Zoom were audio recorded and transcribed. We identified key themes through content analysis with an iterative, inductive, and deductive coding process.
RESULTS: In total, 15 participants reported using web-based platforms for meetings, project management, document sharing, scheduling, and communication. When selecting web-based platforms, participants valued their accessibility, ease of use, and integration with other platforms. Participants speculated that successful web-based collaboration involved platforms that emulate in-person interactions, recognized the digital literacy levels of the team members, intentionally aligned platforms with collaboration goals, and achieved team member buy-in to adopt new platforms.
CONCLUSIONS: Successful web-based engagement in PCOR requires the use of multiple platforms in order to fully meet the asynchronous or synchronous goals of the project. This study identified the key attributes for the successful practice of PCOR on web-based platforms and the common challenges and solutions associated with their use. Our findings provide the best practices for selecting platforms and the lessons learned through web-based PCOR collaborations.