BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct.
METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of \"brief reflections\" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources.
RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible.
CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct.
BACKGROUND: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Background: The COVID-19 pandemic has accelerated and amplified the use of virtual research methods. While online research has several advantages, it also provides greater opportunity for individuals to misrepresent their identities to fraudulently participate in research for financial gain. Participant deception and fraud have become a growing concern for virtual research. Reports of deception and preventative strategies have been discussed within online quantitative research, particularly survey studies. Though, there is a dearth of literature surrounding these issues pertaining to qualitative studies, particularly within substance use research. Results: In this commentary, we detail an unforeseen case study of several individuals who appeared to deliberately misrepresent their identities and information during participation in a virtual synchronous qualitative substance use study. Through our experiences, we offer strategies to detect and prevent participant deception and fraud, as well as challenges to consider when implementing these approaches. Conclusions: Without general awareness and protective measures, the integrity of virtual research methods remains vulnerable to inaccuracy. As online research continues to expand, it is essential to proactively design innovative solutions to safeguard future studies against increasingly sophisticated deception and fraud.

BACKGROUND: Using digital technologies to provide services and supports remotely may improve efficiency and accessibility of healthcare, and support people with disabilities to live independently. This study aimed to explore the experience of using digital technologies to access and provide disability services and supports during the Covid-19 pandemic, from the perspective of people with disabilities, families and service providers.
METHODS: Using a multiple case study design, we purposively sampled three cases based on service user characteristics and geographical reach of the service. We conducted semi-structured interviews with 40 service users and service providers. Topic guides and analysis were informed by the Consolidated Framework for Implementation Research (CFIR). Analysis followed a largely deductive approach, using the CFIR constructs as a coding framework. A summary memo was developed for each case. Influence and strength of each construct was rated to identify constructs that influenced implementation of digital technologies. Ratings were compared across services to identify facilitators and barriers to implementation.
RESULTS: Service users and providers were positive about using digital technologies to access and provide disability services and supports remotely. Advantages over in-person delivery included reduced travel time, increased opportunity for peer support and peer learning, more choice and opportunity to participate in activities, and an enhanced sense of self while accessing services from the secure environment of their home. The urgency to identify new modes of service delivery to meet the needs of service users during Covid-19 was a strong facilitator but did not necessarily result in successful implementation. Other factors that were strong facilitators were the use of adaptations to enable service users to access the online service, service users\' willingness to try the online service, service users\' persistence when they encountered challenges, and the significant time and effort that service providers made to support service users to participate in the online service. Barriers to implementation included the complexity of accessing online platforms, poor design quality of online platforms, and organisations prioritising in-person delivery over online services.
CONCLUSIONS: These findings may allow service providers to leverage facilitators that support implementation of online disability services and supports.

BACKGROUND: Lifestyle medicine (LM) is the use of therapeutic lifestyle changes (including a whole-food, plant-predominant eating pattern; regular physical activity; restorative sleep; stress management; avoidance of risky substances; and positive social connection) to prevent and treat chronic illness. Despite growing evidence, LM is still not widely implemented in health care settings. Potential challenges to LM implementation include lack of clinician training, staffing concerns, and misalignment of LM services with fee-for-service reimbursement, but the full range of factors facilitating or obstructing its implementation and long-term success are not yet understood. To learn important lessons for success and failure, it is crucial to understand the experiences of different LM programs.
OBJECTIVE: This study aims to describe in depth the protocol used to identify barriers and facilitators impacting the implementation of LM in health systems.
METHODS: The study team comprises team members at the American College of Lifestyle Medicine (ACLM), including staff and researchers with expertise in public health, LM, and qualitative research. We recruited health systems that were members of the ACLM Health Systems Council. From among 15 self-nominating health systems, we selected 7 to represent a diversity of geographic location, type, size, expertise, funding, patients, and LM services. Partway through the study, we recruited 1 additional contrasting health system to serve as a negative case. For each case, we conducted in-depth interviews, document reviews, site visits (limited due to the COVID-19 pandemic), and study team debriefs. Interviews lasted 45-90 minutes and followed a semistructured interview guide, loosely based on the Consolidated Framework for Implementation Research (CFIR) model. We are constructing detailed case narrative reports for each health system that are subsequently used in cross-case analyses to develop a contextually rich and detailed understanding of various predetermined and emergent topics. Cross-case analyses will draw on a variety of methodologies, including in-depth case familiarization, inductive or deductive coding, and thematic analysis, to identify cross-cutting themes.
RESULTS: The study team has completed data collection for all 8 participating health systems, including 68 interviews and 1 site visit. We are currently drafting descriptive case narratives, which will be disseminated to participating health systems for member checking and shared broadly as applied vignettes. We are also conducting cross-case analyses to identify critical facilitators and barriers, explore clinician training strategies to facilitate LM implementation, and develop an explanatory model connecting practitioner adoption of LM and experiences of burnout.
CONCLUSIONS: This protocol paper offers real-world insights into research methods and practices to identify barriers and facilitators to the implementation of LM in health systems. Findings can advise LM implementation across various health system contexts. Methodological limitations and lessons learned can guide the execution of other studies with similar methodologies.
UNASSIGNED: DERR1-10.2196/51562.

UNASSIGNED: In 2016, Brazil scaled up the Criança Feliz Program (PCF, from the acronym in Portuguese), making it one of the largest Early Childhood Development (ECD) programs worldwide. However, the PCF has not been able to achieve its intended impact. We aimed to identify barriers and facilitators to achieving the PCF implementation outcomes across the RE-AIM dimensions (Reach, Effectiveness or Efficacy, Adoption, Implementation and Maintenance) during the COVID-19 pandemic.
UNASSIGNED: This comparative case study analysis selected five contrasting municipalities based on population size, region of the country, implementation model, and length of time implementing the PCF. We conducted 244 interviews with PCF municipal team (municipal managers, supervisors, home visitors), families, and cross-sectoral professionals. A rapid qualitative analysis was used to identify themes across RE-AIM dimensions.
UNASSIGNED: Families\' limited knowledge and trust in PCF goals were a barrier to its reach. While the perceived benefit of PCF on parenting skills and ECD enabled reach, the lack of referral protocols to address social needs, such as connecting food-insecure families to food resources, undermined effectiveness. Questions about whether the social assistance sector should be in charge of PCF challenged its adoption. Implementation barriers exacerbated by the COVID-19 pandemic included low salaries, temporary contracts, high turnover, infrequent supervision, lack of an effective monitoring system, and nonexistence or non-functioning multisectoral committees. The absence of institutionalized funding was a challenge for sustainability.
UNASSIGNED: Complex intertwined system-level barriers may explain the unsuccessful implementation of PCF. These barriers must be addressed for Brazil to benefit from the enormous reach of the PCF and the evidence-based nurturing care principles it is based upon.
UNASSIGNED: NIH/NICHD.

BACKGROUND: Familial hypercholesterolemia (FH) is predominantly caused by mutations in the 4 FH candidate genes (FHCGs), namely, low-density lipoprotein receptor (LDLR), apolipoprotein B-100 (APOB-100), proprotein convertase subtilisin/kexin type 9 (PCSK9), and the LDL receptor adaptor protein 1 (LDLRAP1). It is characterized by elevated low-density lipoprotein cholesterol (LDL-c) levels leading to premature coronary artery disease. FH can be clinically diagnosed using established clinical criteria, namely, Simon Broome (SB) and Dutch Lipid Clinic Criteria (DLCC), and can be identified using the Familial Hypercholesterolemia Case Ascertainment Tool (FAMCAT), a primary care screening tool.
OBJECTIVE: This study aims to (1) compare the detection rate of genetically confirmed FH and diagnostic accuracy between the FAMCAT, SB, and DLCC in the Malaysian primary care setting; (2) identify the genetic mutation profiles, including novel variants, in individuals with suspected FH in primary care; (3) explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing in primary care; and (4) evaluate the clinical utility of a web-based FH Identification Tool that includes the FAMCAT, SB, and DLCC in the Malaysian primary care setting.
METHODS: This is a mixed methods evaluation study conducted in 11 Ministry of Health primary care clinics located at the central administrative region of Malaysia. In Work stream 1, the diagnostic accuracy study design is used to compare the detection rate and diagnostic accuracy of the FAMCAT, SB, and DLCC against molecular diagnosis as the gold standard. In Work stream 2, the targeted next-generation sequencing of the 4 FHCGs is used to identify the genetic mutation profiles among individuals with suspected FH. In Work stream 3a, a qualitative semistructured interview methodology is used to explore the experience, concern, and expectation of individuals with suspected FH who have undergone genetic testing. Lastly, in Work stream 3b, a qualitative real-time observation of primary care physicians using the \"think-aloud\" methodology is applied to evaluate the clinical utility of a web-based FH Identification Tool.
RESULTS: The recruitment for Work stream 1, and blood sampling and genetic analysis for Work stream 2 were completed in February 2023. Data collection for Work stream 3 was completed in March 2023. Data analysis for Work streams 1, 2, 3a, and 3b is projected to be completed by June 2023, with the results of this study anticipated to be published by December 2023.
CONCLUSIONS: This study will provide evidence on which clinical diagnostic criterion is the best to detect FH in the Malaysian primary care setting. The full spectrum of genetic mutations in the FHCGs including novel pathogenic variants will be identified. Patients\' perspectives while undergoing genetic testing and the primary care physicians experience in utilizing the web-based tool will be established. These findings will have tremendous impact on the management of patients with FH in primary care and subsequently reduce their risk of premature coronary artery disease.
UNASSIGNED: DERR1-10.2196/47911.

Increasingly, school districts are looking for insights on how to embed a well-being focus across school communities. Well-being in K-12 education is proven to support positive mental health, improve academic performance and contribute to positive outcomes for students and staff. How districts transition to deeply integrate well-being into existing priorities and practices is not well understood. Insights on such shifts can help inform widespread change in education. In 2020, six Canadian school districts participated in case study research to examine how and why districts were able to shift their culture to one that prioritizes well-being. Fifty-five school community members participated in individual semi-structured interviews to explore their perception of well-being in their school communities. Analysis identified six themes: well-being is wholistic and requires balance, student and staff well-being are interconnected, organizational leadership sustains implementation, connection and voice as a catalyst to well-being, building capacity to support well-being action, and charting and re-charting a course. Findings increase our understanding of system-level change, and provide insights to support well-being in education.
Well-being in K-12 education is proven to support positive mental health, improve academic performance and contribute to positive outcomes for students and staff. How school districts can deeply integrate well-being into existing priorities and practices is not well understood. Many districts are looking for insights on how to embed a well-being focus across school communities. These insights can help inform change in K-12 education. In 2020, six Canadian school districts participated in case study research to examine how and why districts were able to shift their culture to one that prioritizes well-being. Fifty-five participants from six districts took part in interviews on the topic of district well-being prioritization. Supporting documents were also reviewed. Qualitative analysis identified six common themes: well-being is wholistic and requires balance, student and staff well-being are interconnected, organizational leadership sustains implementation, connection and voice as a catalyst to well-being, building capacity to support well-being action, and charting and re-charting a course. Study findings increase our understanding of system-level change in K-12 education. Findings provide valuable ‘entry points’ for school and district leaders to consider when making well-being a priority in their own contexts.

This study provides insight into circumstances that facilitate or hamper living at home with advanced dementia until the end of life. Interviews were held with 11 bereaved family caregivers, two general practitioners, and nine case managers, related to a total of 12 persons with advanced dementia who had recently died. Persons with dementia who lived at home until the end of life often had family caregivers that received timely support from professionals and their social network. In the cases where the person with dementia could not live at home until the end of life, safety issues, severely challenging behavior, and high care dependency of the person with dementia played key roles. Case management and a continuous process of advance care planning will improve the chance that the end-of-life setting is in accordance with the key values and needs of both the person with dementia and family caregivers.

UNASSIGNED: Infodemic management is an integral part of pandemic management. Ghana Health Services (GHS) together with the UNICEF (United Nations International Children\'s Emergency Fund) Country Office have developed a systematic process that effectively identifies, analyzes, and responds to COVID-19 and vaccine-related misinformation in Ghana.
UNASSIGNED: This paper describes an infodemic management system workflow based on digital data collection, qualitative methodology, and human-centered systems to support the COVID-19 vaccine rollout in Ghana with examples of system implementation.
UNASSIGNED: The infodemic management system was developed by the Health Promotion Division of the GHS and the UNICEF Country Office. It uses Talkwalker, a social listening software platform, to collect misinformation on the web. The methodology relies on qualitative data analysis and interpretation as well as knowledge cocreation to verify the findings.
UNASSIGNED: A multi-sectoral National Misinformation Task Force was established to implement and oversee the misinformation management system. Two members of the task force were responsible for carrying out the analysis. They used Talkwalker to find posts that include the keywords related to COVID-19 vaccine-related discussions. They then assessed the significance of the posts on the basis of the engagement rate and potential reach of the posts, negative sentiments, and contextual factors. The process continues by identifying misinformation within the posts, rating the risk of identified misinformation posts, and developing proposed responses to address them. The results of the analysis are shared weekly with the Misinformation Task Force for their review and verification to ensure that the risk assessment and responses are feasible, practical, and acceptable in the context of Ghana.
UNASSIGNED: The paper describes an infodemic management system workflow in Ghana based on qualitative data synthesis that can be used to manage real-time infodemic responses.

Permanent Supportive Housing (PSH), which provides subsidies for independent housing and supportive services, is an evidence-based practice that improves health and housing for homeless experienced persons. Though most PSH is scattered-site, that is, housing dispersed throughout the mainstream rental market, project-based PSH offers housing and supportive services in dedicated facilities with on-site services. In 2013, the Veterans Health Administration (VA) at Greater Los Angeles opened a novel project-based PSH program located on a VA campus. To inform plans to expand project-based PSH at this VA, we examined participants\' experiences in this program. We aimed to identify participant characteristics that suggested they were well suited for the planned PSH expansion; to characterize services that participants found valuable in this setting; and to highlight gaps between participants\' needs and PSH services provided.
We performed semi-structured interviews with a convenience sample (n = 24) of participants who had engaged in this project-based PSH program. Interviews asked why participants selected housing on a VA campus and explored valued program characteristics, designs, and services. Using rapid analysis methods, we generated templated summaries of each participant\'s responses across the domains of our interview guide, then used matrix analyses to identify salient themes across the interviews.
Participants appreciated the ease of access to medical and mental health services; however, as services were assumed to be optimized by virtue of co-location with VA healthcare, their PSH providers often did not link them with non-VA social services as assertively as desired. Many participants raised concerns about building safety and on-site substance use. A lack of participant engagement in program oversight, often leading to conflicts with staff and building management, was also highlighted in our interviews.
Given the value placed on ease of access to healthcare, these data suggest the value of this PSH model for persons with healthcare vulnerabilities. Specific recommendations for the planned PSH expansion include: (1) continuation of proximate, open-access healthcare; (2) clear tenant policies; (3) tenant councils for each development; (4) staff knowledgeable of non-VA resources and social services; (5) Veteran-preferred hiring practices by Property/Service management; (6) gender-specific accommodations; and (7) robust 24/7 security on-site.