Assessing Per- and Polyfluoroalkyl Substances in Fish Fillet Using Non-Targeted Analyses.

Per- and polyfluoroalkyl substances (PFAS) are a class of thousands of man-made chemicals that are persistent and highly stable in the environment. Fish consumption has been identified as a key route of PFAS exposure for humans. However, routine fish monitoring targets only a handful of PFAS, and non-targeted analyses have largely only evaluated fish from heavily PFAS-impacted waters. Here, we evaluated PFAS in fish fillets from recreational and drinking water sources in central North Carolina to assess whether PFAS are present in these fillets that would not be detected by conventional targeted methods. We used liquid chromatography, ion mobility spectrometry, and mass spectrometry (LC-IMS-MS) to collect full scan feature data, performed suspect screening using an in-house library of 100 PFAS for high confidence feature identification, searched for additional PFAS features using non-targeted data analyses, and quantified perfluorooctanesulfonic acid (PFOS) in the fillet samples. A total of 36 PFAS were detected in the fish fillets, including 19 that would not be detected using common targeted methods, with a minimum of 6 and a maximum of 22 in individual fish. Median fillet PFOS levels were concerningly high at 11.6 to 42.3 ppb, and no significant correlation between PFOS levels and number of PFAS per fish was observed. Future PFAS monitoring in this region should target more of these 36 PFAS, and other regions not considered heavily PFAS contaminated should consider incorporating non-targeted analyses into ongoing fish monitoring studies.

He/She/They - gender inclusivity in developing and using health-related questionnaires: a scoping review.

PURPOSE: To ensure the recognition and participation of all potential respondents in health research, surveys and care, including LGBTQIA + broadly, and trans people, specifically, the use of inclusive language should be considered. This scoping review aimed to identify and describe strategies considered for gender inclusivity in development and use of health questionnaires and Patient Reported Outcomes Measures (PROMs). METHODS: A systematic search of peer reviewed publications between January 2000 and September 2022 was conducted in Scopus, ProQuest Central, Ovid Medline (PubMed and EBSCO). Two reviewers independently screened identified publications titles and abstracts, followed by full text screening and data extraction from eligible articles. RESULTS: The search of over 5000 publications, retained 18; most acknowledged gaps in representation and advocated for gender-inclusive language. Eight articles discussed exclusion from health care and health research for gender minority groups due to the use of gendered language. Improved reliability, validity and response rates were associated with the use of gender-neutral language in seven articles. Only one article reported finding irritation among cisgender males when non-binary gender response options were used. One paper, focussing on instruments for Rheumatoid Arthritis, discussed gaps in representation if diverse gender identities were not considered when developing PROMs. CONCLUSION: This scoping review points to the importance of adopting gender-inclusive language in health questionnaires and surveys to reduce the risk of excluding gender minority groups. Despite finding very few specific examples of how others have used gender-inclusive language in health questionnaires, many strengths of gender-inclusive language usage were identified.

People from the LGBTQIA + communities are often excluded from health research and from completing heath surveys as they are not able to identify with the questions about male or female genders. This scoping review aimed to examine the literature for any strategies developers of health questionnaires may have come up with to ensure inclusion of all demographic groups. Most of the identified literature highlights the importance of adopting gender-inclusive language in health questionnaires to reduce the risk of excluding gender minority groups. Despite many strengths of gender-inclusive language usage being identified, only a few specific examples were identified of how others have used gender-inclusive language in health questionnaires.

Cancer in pregnancy - The obstetrical management.

Cancer in pregnancy, defined as a cancer diagnosed during pregnancy, is a rare but severe condition presenting both clinical and ethical challenges. During the last two decades a paradigm shift has occurred towards recommending similar staging and treatment regimens of pregnant and non-pregnant cancer patients. This strategy is a result of an increasing number of reassuring reports on chemotherapy treatment in pregnancy after the first trimester. The management of cancer in pregnancy should be managed in a multidisciplinary team where staging, oncological treatment, social and mental care, timing of delivery, and follow-up of the infant should be planned. Due to the rarity, centralization is recommended to allow experience accumulation. Furthermore, national and international advisory boards are supportive when there is a lack of expertise.

Developing a Statewide Strategy for Meaningful Youth Engagement: Insights from a Youth-Driven Program in Wisconsin.

PURPOSE: There are various ways to integrate the lived experiences and perspectives of youth and young adults into Maternal Child Health (MCH) goals, initiatives, and programs. This article describes the history, evolution, and current strategy of a program that engages youth from across the state of Wisconsin. It serves as an example for others who may be interested in building capacity for youth leadership and engagement. DESCRIPTION: The Providers and Teens Communicating for Health (PATCH) Program started as a community-based pilot project and evolved into a robust statewide youth engagement infrastructure. CONCLUSION: Meaningful youth engagement requires capacity, adaptability, and expertise. Thus, in this case, it has proven advantageous to develop complementary and mutually beneficial partnerships to support adolescent health more effectively and efficiently in Wisconsin.

"We don't separate out these things. Everything is related": Partnerships with Indigenous Communities to Design, Implement, and Evaluate Multilevel Interventions to Reduce Health Disparities.

Multilevel interventions (MLIs) are appropriate to reduce health disparities among Indigenous peoples because of their ability to address these communities' diverse histories, dynamics, cultures, politics, and environments. Intervention science has highlighted the importance of context-sensitive MLIs in Indigenous communities that can prioritize Indigenous and local knowledge systems and emphasize the collective versus the individual. This paradigm shift away from individual-level focus interventions to community-level focus interventions underscores the need for community engagement and diverse partnerships in MLI design, implementation, and evaluation. In this paper, we discuss three case studies addressing how Indigenous partners collaborated with researchers in each stage of the design, implementation, and evaluation of MLIs to reduce health disparities impacting their communities. We highlight the following: (1) collaborations with multiple, diverse tribal partners to carry out MLIs which require iterative, consistent conversations over time; (2) inclusion of qualitative and Indigenous research methods in MLIs as a way to honor Indigenous and local knowledge systems as well as a way to understand a health disparity phenomenon in a community; and (3) relationship building, maintenance, and mutual respect among MLI partners to reconcile past research abuses, prevent extractive research practices, decolonize research processes, and generate co-created knowledge between Indigenous and academic communities.

A Roadside Precision Monocular Measurement Technology for Vehicle-to-Everything (V2X).

Within the context of smart transportation and new infrastructure, Vehicle-to-Everything (V2X) communication has entered a new stage, introducing the concept of holographic intersection. This concept requires roadside sensors to achieve collaborative perception, collaborative decision-making, and control. To meet the high-level requirements of V2X, it is essential to obtain precise, rapid, and accurate roadside information data. This study proposes an automated vehicle distance detection and warning scheme based on camera video streams. It utilizes edge computing units for intelligent processing and employs neural network models for object recognition. Distance estimation is performed based on the principle of similar triangles, providing safety recommendations. Experimental validation shows that this scheme can achieve centimeter-level distance detection accuracy, enhancing traffic safety. This approach has the potential to become a crucial tool in the field of traffic safety, providing intersection traffic target information for intelligent connected vehicles (ICVs) and autonomous vehicles, thereby enabling V2X driving at holographic intersections.

Characteristics of water quality mitigation measures that lead to greater adoption on farms.

Globally, agriculture is a significant pressure on water quality. While nutrient and sediment loss from agricultural land to water can be scientifically complex, mitigation measures primarily focus on reducing farm nutrient stocks or blocking loss pathways. The appropriateness of mitigation measures is dependent on the identification of specific context-related risks on individual farms. However, advisers also need to consider the likelihood of uptake of measures by farmers. Past research has looked at uptake of particular mitigation measures or a small range of measures. This research expands the literature with an analysis of uptake of a broad and diverse range of measures. Farm characteristics, farmer norms, knowledge required and costs (direct and indirect) associated with individual mitigation measures are investigated to identify factors that could influence greater adoption. Results show that alignment to farmer norms and lower specific costs were associated with high adoption rates. These results have implications for advisers in relation to the selection of measures most likely to be adopted by farmers, and also for policy-makers in relation to the need to incentivise the adoption of high-cost measures.

Level of readiness of employees of Systems Plus College Foundation (SPCF) on Disaster Risk-Reduction Management (DRRM).

OBJECTIVE: To determine the level of readiness on disaster risk-reduction management among employees of an educational institution. METHODS: The descriptive, evaluative study was conducted from March to April 2022 at 6 branches of Systems Plus College Foundation, Philippines, in Balibago, Rizal, Miranda, San Fernando, Caloocan and Cubao after approval from the ethics review committee of the Our Lady of Fatima University, Philippines, and comprised employees who were associated with the college for at least 6 months. Data was collected using Google Forms, and a validated tool was used to assess the disaster risk-reduction management readiness. The responses were categorised into 5 groups, ranging from 'very much ready' to 'not ready'. Gathered data was analysed by using SPSS version 20. Mean results were derived and presented with standard deviation. RESULTS: The responses suggested moderate readiness regarding structural safety codes 3.02±0.98, non-structural safety codes 3.02±1.04, availability of emergency supplies and equipment 2.84±1.09, and servicing and maintenance 2.85±1.03. CONCLUSIONS: Increasing the level of readiness related to disaster risk-reduction management must be given priority to ensure the safety of the employees in a higher education institution.

Risk perception about communicable and vector borne diseases among international travellers to Pakistan: A cross sectional study.

With the rise in air travel, the risk of diseases travelling from one geographical area to another has also increased. Relatively little is known about how travellers know and perceive the health risks associated with travel and how they adopt preventive measures before and while travelling abroad. The objective of this study is to determine the risk perception about communicable and vector-borne diseases among international travellers arriving from different countries and to find any association between the level of risk perception and independent variables. A cross-sectional study was conducted with 426 participants enrolled through convenient sampling technique. An already validated questionnaire was used to collect information. Chi square test was applied to ascertain any significant association between dependent and independent variables. Out of 426 respondents, only 226 (53%) had a high risk perception, whereas 220 (47%) had a low risk perception. A significant association was noted between the level of risk perception and gender (x2=20.9, p=0.000), level of education (x2=42.9, p=0.000), nationality (x2=7.5, p= 0.006) and region of arrival of the passengers (x2=26.2, p= 0.000). The results of the study revealed that 220 (47%) of the travellers had a low risk perception that may lead to an increase in the burden on healthcare system in Pakistan as well as exporting any new disease from Pakistan to other parts of the world where it does not already exist.

Foundational concepts of collaborative practice with parents in occupational therapy for children.

INTRODUCTION: In occupational therapy for children, collaborative practice with parents is crucial for meaningful family-centred interventions, yet it remains undefined and inconsistently addressed. This study aimed to establish foundational concepts for collaborative practice with parents in occupational therapy for children in progressing the field with a universal description. METHODS: This paper encompasses the second dataset of a larger scoping review and a preliminary validation of findings by an advisory panel. Data were gathered from indexed sources on collaborative practice with parents in occupational therapy for children (ages 0-10) using MedLine, PsychInfo, ERIC, Embase, OTSeeker, Scopus, and ProQuest Central. Data were extracted, charted, and descriptively analysed by paired independent reviewers. The Joanna Briggs Institute Manual and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis-extension for Scoping Reviews were used. A draft definition of collaborative practices, developed based on preliminary review findings and an operational definition, was validated by an advisory panel of 13 experienced Australian occupational therapists, whose input was integrated into a final, comprehensive description of collaborative practice. RESULTS: The scoping review encompassed 299 sources, revealing three major components of collaborative practice: 'collaborative practice aims', 'parent-therapist partnership', and 'strategies for collaboration'. The advisory panel endorsed the draft definition, confirmed its professional relevance, and suggested some modifications. CONCLUSION: The major outcome of this study is an evidence-based and discipline-specific preliminary description of collaborative practice with parents in occupational therapy for children. This description provides a common language and foundational concepts for the future development of a collaborative practice framework to guide practice and research. Future studies can explore specific components, exploring their mechanisms and significance. Further expanded validation is required, incorporating the perspectives of a wider community of occupational therapists and families to enhance the description's applicability.

A practical method for integrating community priorities in planning and implementing cancer control programs.

PURPOSE: Community engagement is essential in effective public health programs. This paper illustrates the methods used to engage community in the development of a multi-level implementation intervention to address cancer disparities related to hereditary cancer syndromes. METHODS: Implementation Mapping (IM), was used to guide the co-creation of an intervention. Key partners were recruited to a 13-member statewide community advisory board (CAB) representing healthcare and community-based organizations. As part of a needs assessment, a 3-round modified Delphi method with the CAB was used to identify implementation outcomes to use in later steps of IM. An anonymous online survey of a validated community engagement measure assessed CAB members' satisfaction with the process. RESULTS: Using a modified Delphi method as part of the needs assessment of IM, the CAB identified three broad categories of strategies: Changing infrastructure using patient navigation; training and educating patients, navigators and providers; and supporting clinicians in case identification and management. Self-reported satisfaction with the IM and Delphi process was high. CONCLUSIONS: Implementation Mapping facilitated the use of available evidence, new data, and community engagement to identify strategies to improve the delivery of programs to reduce hereditary cancer disparities. The modified Delphi method was easy to administer in a virtual environment and may be a useful for others in community-engaged research.

Twenty-five years of novel drug approvals in rheumatology.

The field of rheumatology has experienced dozens of novel drug approvals in the past two and a half decades, but the regulatory mechanisms underpinning these decisions are not well understood. In the USA, the Food and Drug Administration (FDA) evaluates the safety and efficacy of novel drugs through the New Drug Application (NDA) process. When additional content expertise is required to evaluate scientific or technical matters, the FDA may convene Human Drug Advisory Committees. To better understand the landscape of rheumatology NDAs and the FDA use of advisory committees, we performed a review of all rheumatic disease drug applications from 1996 to 2021 that were granted approval by the FDA. Our review identified 31 NDAs, seven of which utilized an advisory committee. The indications for using advisory committees and their influence on ultimate approvals was not clear. Recommendations to improve transparency and increase public trust in FDA decisions are provided.

Human papillomavirus vaccination guideline update: American Cancer Society guideline endorsement.

Answer questions and earn CME/CNE The American Cancer Society (ACS) reviewed and updated its guideline on human papillomavirus (HPV) vaccination based on a methodologic and content review of the Advisory Committee on Immunization Practices (ACIP) HPV vaccination recommendations. A literature review was performed to supplement the evidence considered by the ACIP and to address new vaccine formulations and recommendations as well as new data on population outcomes since publication of the 2007 ACS guideline. The ACS Guideline Development Group determined that the evidence supports ACS endorsement of the ACIP recommendations, with one qualifying statement related to late vaccination. The ACS recommends vaccination of all children at ages 11 and 12 years to protect against HPV infections that lead to several cancers and precancers. Late vaccination for those not vaccinated at the recommended ages should be completed as soon as possible, and individuals should be informed that vaccination may not be effective at older ages. CA Cancer J Clin 2016;66:375-385. © 2016 American Cancer Society.

National advisory panels for childhood cancer in the United Kingdom: An evaluation of current practice and a best practice statement for the future.

BACKGROUND: National advisory panels (NAPs) have been established for the care of children and young people (CYP) with cancer in the United Kingdom since 2011, with an increase in panel number in recent years. Their practice has not previously been reviewed; therefore, we sought to evaluate the role, practice and impact of six selected NAPs offering expertise in ependymoma, histiocytosis, leukaemia, neuroblastoma, renal tumours and sarcoma. PROCEDURE: This service evaluation used mixed methodology, including review of NAP documentation, semi-structured interviews with the NAP chairs and an analysis of the cases referred for discussion. RESULTS: Total 1110 referrals were analysed. Results demonstrated the significant scope and amount of work undertaken by the NAPs, largely testament to the commitment of the panel members. Specific roles fulfilled have been highlighted, and NAP recommendations have been shown to influence clinical decision-making and be implemented in the majority of cases. Despite widespread good practice, areas to address have been identified; these include clarity regarding NAP membership, consistency in recommendations, the consideration of holistic information to promote personalised management and the exploration of wider multidisciplinary team roles. CONCLUSIONS: In the context of increasing demand and the escalating number of NAPs, it is timely to consider how service improvement can be facilitated. Best practice guidelines have been formulated as a product of this study, to promote a sustainable and effective model for NAPs. Review and benchmarking national panel performance against these guidelines will drive high standards of care going forward and they should be embedded as standard practice.

Barriers and facilitators to the engagement of physical activity among Black and African American cancer survivors during and after treatments.

PURPOSE: To identify physical activity (PA) barriers and facilitators among Black and African American (Black/AA) cancer survivors that should be considered in future PA intervention development for this population. METHODS: A community advisory board (CAB) of Black/AA cancer survivors and patient advocates guided in-depth qualitative interviews (n = 19) that were completed via telephone using a semi-structured interview guide. Interviews were transcribed verbatim, and data were analyzed using directed content analysis to detail a report of PA barriers and facilitators during and after cancer treatment. The CAB reviewed and interpreted these barriers and facilitators to identify the final results. RESULTS: Survivors (n = 19) of nine different types of cancer completed interviews. PA barriers during cancer treatments included physical and psychological suffering. PA barriers after cancer treatments included social and environmental constraints (e.g., lack of access needed for PA, safety concerns, and competing priorities). PA facilitators both during and after cancer treatments included family support, faith, and support from other survivors. PA facilitators during treatment also included feeling better after doing PA, setting realistic and flexible goals, and gaining a sense of control of one's health by striving for PA goals. CONCLUSIONS: To increase PA among Black/AA cancer survivors, PA interventions are needed that address structural barriers, include the role of faith, leverage family support, highlight the psychological benefits of PA, and use goal setting.

A scoping review of resilience among transition-age youth with serious mental illness: tensions, knowledge gaps, and future directions.

INTRODUCTION: The study of resilience among transition-age youth (aged 16-29 years) living with serious mental illness (SMI) has provided a promising new direction for research with the capacity to explore individuals' strengths and resources. However, variability in how resilience is defined and measured has led to a lack of conceptual clarity. A comprehensive synthesis is needed to understand current trends and gaps in resilience research among this population. The purpose of the current study was to map how resilience has been conceptualized and operationalized among transition-age youth with SMI, explore resilience factors and outcomes that have been studied, and recommend areas for future research. METHODS: A six-stage scoping review methodology was used to systematically identify relevant empirical literature across multiple databases (MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Scopus), addressing transition-age youth diagnosed with SMI and resilience. Topic consultation and reaction meetings were conducted to gather feedback from transition-age youth with SMI, researchers, and clinicians during the review process to enhance the applicability of the review findings. A meta-narrative approach was used to organize included studies into research traditions (i.e., paradigms of inquiry with similar storylines, theoretical and methodological orientations). Resilience factors and outcomes, and the consultative meetings, were analyzed using content analysis. RESULTS: Twenty-four studies met inclusion criteria (14 quantitative, 9 qualitative, 1 mixed-method). Four research traditions were identified, each contributing a unique storyline which conceptualized and operationalized resilience in slightly different ways: Stress Adaptation, Person-Environment Interactions, Recovery-Focused, and Critical and Cultural Perspectives. Resilience factors and outcomes were most commonly evaluated at the individual-level or within the immediate environment (e.g., personal characteristics, social support networks). Limited research has explored the influence of macro-level systems and health inequalities on resilience processes. Results from the consultative meetings further demonstrated the importance of health services and sociocultural factors in shaping processes of resilience among youth. CONCLUSION: The present results may be used to inform future work, as well as the development of age-appropriate, strengths-based, and resilience-oriented approaches to service delivery. Interdisciplinary and intersectional research that prioritizes community and youth engagement is needed to advance current understandings of resilience among transition-age youth with SMI.

'Just because we're younger doesn't mean our opinions should be any less valued': A qualitative study of youth perspectives on a Youth Advisory Council in a mental healthcare context.

INTRODUCTION: Recognition of the importance of youth engagement in youth mental health and/or addiction (MHA) service design and delivery is increasing. Youth Advisory Councils embedded in MHA organizations represent one strategy that allows youth to be involved in MHA at the individual, organization and systemic levels. This level of involvement can facilitate positive outcomes for both the youth and the organization. As these councils become more common, it is important that organizations are prepared to partner with the participating youth. This study uses a descriptive qualitative approach to understand the motivations and expectations of youth with lived experience with MHA concerns who were beginning to work on a Youth Advisory Council in an MHA setting in the Greater Toronto Area. METHODS: Semistructured interviews were conducted with each youth, ages 16-26, on the advisory council (N = 8) to understand their motivations, expectations and goals coming into the work. Interviews were transcribed verbatim and analysed using a reflexive thematic analysis. RESULTS: Analysis resulted in five overarching themes: providing opportunities for youth learning and growth, platforming youth, empowering youth, embracing youth leadership and promoting youth-driven change. The findings illustrate that these youth came into the Youth Advisory Council motivated to create positive change in the mental health system, take on leadership roles and had high expectations for organizational support. Our analyses provide insight for organizations planning and implementing Youth Advisory Councils in the MHA sector with the goal of best supporting youth in driving positive change across the system. CONCLUSION: Youth want to be provided authentic opportunities for their engagement to make a difference. MHA organizations must embrace youth leadership and move towards listening to youth experience and acting on youth recommendations to enhance service design and implementation to improve access and to better meet the needs of youth utilizing these services. PATIENT OR PUBLIC CONTRIBUTIONS: This study incorporated service users, including youth ages 16-26 with lived experience of MHA concerns who served on the Youth Advisory Council at the Family Navigation Project, Sunnybrook. Youth Advisory Council members contributed to two relevant research activities: (1) youth reviewed the draft interview guide before data collection, and their feedback was prioritized in the final version and (2) youth contributed to knowledge translation through contributing to academic conference presentations.

Evaluating the effect of a 12-month youth advisory group on adolescent's leadership skills and perceptions related to chronic disease prevention research: a mixed-methods study.

BACKGROUND: Youth Advisory Groups (YAGs) represent a promising method to engage adolescents in research of relevance to them and their peers. However, YAGs are rarely implemented or evaluated in chronic disease prevention research. The aims of this study were firstly, to evaluate the effect of participation in a 12-month YAG on adolescents' leadership skills and perceptions related to chronic disease prevention research and secondly, to evaluate the process of establishing and facilitating a 12-month YAG and identify barriers and enablers to establishment and facilitation. METHODS: This study was a 12-month pre-post study. Eligible participants were adolescents (13-18-years) and current members of an established YAG. Data collection involved online surveys and semi-structured interviews at baseline, six-months and 12-months follow-up. Participatory outcomes such as self-efficacy, leadership skills, and collective participation were derived from Youth Participatory Action Research Principles (YPAR), and the Lansdown-UNICEF conceptual framework for measuring outcomes of adolescent participation. Process evaluation data were captured via meeting minutes, Slack metrics and researcher logs. Quantitative data was analysed using descriptive statistics and qualitative data was thematically analysed using a reflexive thematic analysis approach. RESULTS: Thirteen (13/16) YAG youth advisors consented to participate in the evaluation study (mean age 16.0 years, SD 1.3; 62% (8/13) identified as female). Survey data assessing participatory outcomes found an increase in leadership and life skills scores over 12-months (+ 8.90 points). Semi-structured interview data collected over the 12-month term revealed three key themes namely: influence, empowerment, and contribution. Comparison of pre-post themes determined a positive trend at follow-ups, demonstrating improved participatory outcomes. Process indicators revealed that at 12-month follow-up the YAG was implemented as planned. Semi-structured interview data determined barriers to YAG facilitation included time and limited face-to-face components, while enablers to YAG facilitation included flexibility, accessible delivery methods, and a supportive adult facilitator. CONCLUSION: This study found that a YAG fostered positive participatory outcomes and unique opportunities for youth participants. A successful YAG based on YPAR principles requires researchers to ensure YAG establishment and facilitation is an iterative process. Taking into consideration important barriers and enablers to YAG facilitation ensures adolescent engagement in a YAG is both meaningful and impactful.

Regulation of community advisory boards during conduct of clinical trials in Uganda: a qualitative study involving stakeholders.

BACKGROUND: Community advisory structures such as Community Advisory Boards (CABs) play an important role of helping researchers to better understand the community at each phase of the clinical trial. CABs can be a source of accurate information on the community, its perception of proposed research and may identify factors that make community members vulnerable to the problem under investigation. Although CABs help to build mutually beneficial relationships between the researcher(s) and the communities in which the clinical trial is being implemented, effective engagement would require ethical guidance and regulatory oversight. The study assessed the stakeholders' perspectives regarding the regulatory oversight of CABs in Uganda. METHODS: This was an exploratory study employing qualitative methods of data collection and analysis. Key informant interviews (KIIs) with the trial investigators, CAB chairpersons, community liaison officers, regulators and Research Ethics Committee (REC) chairpersons were conducted. A KII guide was designed and utilized during key informant interviews. The guide included questions on role of investigators and CAB members in clinical trials; challenges of community engagement; facilitation of CABs; regulatory oversight of CABs; work relationships between investigators and CABs; and opinions on how community trials should be conducted among others. All interviews were conducted in English. Qualitative data were transcribed verbatim. A code book was generated based on the transcripts and study objectives. Thematic analysis was used to analyze data and identify themes. Atlas ti was used to support data analysis. RESULTS: Of the 34 respondents, 35.3% were investigators, 32.3% CAB chairpersons, 23.5% research regulators/REC Chairs and 8.8% community liaison officers. The findings of the study revealed that CABs are appointed by the research institution/researcher, operate under the guidance of the researcher with limited independence. Additionally, the CABs provide voluntary service and lack guidelines or regulatory oversight. Four themes emerged. CONCLUSION: The operations and activities of CABs are not regulated by the national regulators or RECs. The regulatory oversight of CABs should be based on contextualized ethical guidelines. Need for additional training in research ethics, community engagement and sensitization on available ethics guidelines for research.

Addressing non-response data for standardized post-acute functional items.

BACKGROUND: The post-acute patient standardized functional items (Section GG) include non-response options such as refuse, not attempt and not applicable. We examined non-response patterns and compared four methods to address non-response functional data in Section GG at nation-wide inpatient rehabilitation facilities (IRF). METHODS: We characterized non-response patterns using 100% Medicare 2018 data. We applied four methods to generate imputed values for each non-response functional item of each patient: Monte Carlo Markov Chains multiple imputations (MCMC), Fully Conditional Specification multiple imputations (FCS), Pattern-mixture model (PMM) multiple imputations and the Centers for Medicare and Medicaid Services (CMS) approach. We compared changes of Spearman correlations and weighted kappa between Section GG and the site-specific functional items across impairments before and after applying four methods. RESULTS: One hundred fifty-nine thousand six hundred ninety-one Medicare fee-for-services beneficiaries admitted to IRFs with stroke, brain dysfunction, neurologic condition, orthopedic disorders, and debility. At discharge, 3.9% (self-care) and 61.6% (mobility) of IRF patients had at least one non-response answer in Section GG. Patients tended to have non-response data due to refused at discharge than at admission. Patients with non-response data tended to have worse function, especially in mobility; also improved less functionally compared to patients without non-response data. Overall, patients coded as 'refused' were more functionally independent in self-care and patients coded as 'not applicable' were more functionally independent in transfer and mobility, compared to other non-response answers. Four methods showed similar changes in correlations and agreements between Section GG and the site-specific functional items, but variations exist across impairments between multiple imputations and the CMS approach. CONCLUSIONS: The different reasons for non-response answers are correlated with varied functional status. The high proportion of patients with non-response data for mobility items raised a concern of biased IRF quality reporting. Our findings have potential implications for improving patient care, outcomes, quality reporting, and payment across post-acute settings.