All together: Integrated care for youth with type 1 diabetes.

OBJECTIVE: We describe the implementation and evaluation of an integrated, stepped care model aimed to identify and address the concerns of adolescents with type 1 diabetes (T1D) associated with diabetes-related quality of life (DRQoL), emotional well-being, and depression. RESEARCH DESIGN AND METHODS: The care model with 4 steps: (1) Systematic identification and discussion of concerns salient to adolescents; (2) Secondary screening for depressive symptoms when indicated; (3) Developing collaborative treatment plans with joint physical and mental health goals; and (4) Psychiatric assessment and embedded mental health treatment; was implemented into an ambulatory pediatric diabetes clinic and evaluated using quantitative and qualitative methods. RESULTS: There were 236 adolescents (aged 13-18 years) with T1D that were enrolled in the care model. On average adolescents identified three concerns associated with their DRQoL and 25% indicated low emotional well-being. Fifteen adolescents received a psychiatric assessment and embedded mental health treatment. Both adolescents and caregivers were appreciative of a broader, more holistic approach to their diabetes care and to the greater focus of the care model on adolescents, who were encouraged to self-direct the conversation. Parents also appreciated the extra level of support and the ability to receive mental health care for their adolescents from their own diabetes care team. CONCLUSION: The initial findings from this project indicate the acceptability and, to limited extent, the feasibility of an integrated stepped care model embedded in an ambulatory pediatric diabetes clinic led by an interdisciplinary care team. The care model facilitated the identification and discussion of concerns salient to youth and provided a more holistic approach.

Making sense of symptoms, clinicians and systems: a qualitative evaluation of a facilitated support group for patients with medically unexplained symptoms.

OBJECTIVES: Health services to date have inadequately addressed the physical and mental health needs of patients with medically unexplained symptoms. This qualitative study evaluates a piloted facilitated support group (FSG) developed for patients with medically unexplained symptoms to inform recommendations and resources for this patient population. METHODS: Using a qualitative descriptive design, we conducted and thematically analyzed semi-structured interviews with participants (n = 8) and facilitators (n = 4) to explore their experiences of the facilitated support group. Common themes that captured strengths and challenges of the facilitated support group were identified. RESULTS: The following key themes were identified through analysis of the data: Participants described 1) feeling validated through sharing similar experiences with peers; 2) learning practical symptom management and coping strategies; and 3) gaining new perspectives for navigating conversations with PCPs. CONCLUSIONS: Our findings show that a facilitated support group may provide additional forms of support and resources for patients with medically unexplained symptoms, filling a gap in currently available clinical care offered by health care professionals. Potential implications: This paper highlights lessons learned that can inform the design and delivery of future supports and resources directed toward optimizing patient care for this underserved patient population. Our findings are relevant to those who are involved in direct patient care or involved in designing and implementing self-management programs.

Canadian adaptation of the Newest Vital Sign©, a health literacy assessment tool.

OBJECTIVE: The Newest Vital Sign© (NVS) was developed in the USA to measure patient health literacy in clinical settings. We adapted the NVS for use in Canada, in English and French, and created a computerized version. Our objective was to evaluate the reliability of the Canadian NVS as a self-administered computerized tool. DESIGN: We used a randomized crossover design with a washout period of 3-4 weeks to compare health literacy scores obtained using the computerized version with scores obtained using the standard interviewer-administered NVS. ANOVA models and McNemar's tests assessed differences in outcomes assessed with each version of the NVS and order effects of the testing. SETTING: Participants were recruited from multicultural catchment areas in Ontario and Nova Scotia. SUBJECTS: English- and French-speaking adults aged 18 years or older. RESULTS: A total of 180 (81 %) of the 222 adults (112 English/110 French) initially recruited completed both the interviewer-NVS and computer-NVS. Scores for those who completed both assessments ranged from 0 to 6 with a mean of 3·63 (sd 2·11) for the computerized NVS and 3·41 (sd 2·21) for the interview-administered NVS. Few (n 18; seven English, eleven French) participants' health literacy assessments differed between the two versions. CONCLUSIONS: Overall, the computerized Canadian NVS performed as well as the interviewer-administered version for assessing health literacy levels of English- and French-speaking participants. This Canadian adaptation of the NVS provides Canadian researchers and public health practitioners with an easily administered health literacy assessment tool that can be used to address the needs of Canadians across health literacy levels and ultimately improve health outcomes.

Targeted peptide measurements in biology and medicine: best practices for mass spectrometry-based assay development using a fit-for-purpose approach.

Adoption of targeted mass spectrometry (MS) approaches such as multiple reaction monitoring (MRM) to study biological and biomedical questions is well underway in the proteomics community. Successful application depends on the ability to generate reliable assays that uniquely and confidently identify target peptides in a sample. Unfortunately, there is a wide range of criteria being applied to say that an assay has been successfully developed. There is no consensus on what criteria are acceptable and little understanding of the impact of variable criteria on the quality of the results generated. Publications describing targeted MS assays for peptides frequently do not contain sufficient information for readers to establish confidence that the tests work as intended or to be able to apply the tests described in their own labs. Guidance must be developed so that targeted MS assays with established performance can be made widely distributed and applied by many labs worldwide. To begin to address the problems and their solutions, a workshop was held at the National Institutes of Health with representatives from the multiple communities developing and employing targeted MS assays. Participants discussed the analytical goals of their experiments and the experimental evidence needed to establish that the assays they develop work as intended and are achieving the required levels of performance. Using this "fit-for-purpose" approach, the group defined three tiers of assays distinguished by their performance and extent of analytical characterization. Computational and statistical tools useful for the analysis of targeted MS results were described. Participants also detailed the information that authors need to provide in their manuscripts to enable reviewers and readers to clearly understand what procedures were performed and to evaluate the reliability of the peptide or protein quantification measurements reported. This paper presents a summary of the meeting and recommendations.

Gender Influences on Return to Work After Mild Traumatic Brain Injury.

OBJECTIVE: To examine the influence of gender on the return to work experience of workers who sustained a work-related mild traumatic brain injury (TBI). DESIGN: Qualitative study using in-depth telephone interviews. SETTING: Community. PARTICIPANTS: Purposive sampling was used to recruit participants. Participants were adults (N=12; males, n=6, females, n=6) with a diagnosis of mild TBI sustained through a workplace injury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Our findings suggest that gender impacts return to work experiences in multiple ways. Occupational and breadwinner roles were significant for both men and women after work-related mild TBI. Women in this study were more proactive than men in seeking and requesting medical and rehabilitation services; however, the workplace culture may contribute to whether and how health issues are discussed. Among our participants, those who worked in supportive, nurturing (eg, feminine) workplaces reported more positive return to work (RTW) experiences than participants employed in traditionally masculine work environments. For all participants, employer and coworker relations were critical elements in RTW outcomes. CONCLUSIONS: The application of a gender analysis in this preliminary exploratory study revealed that gender is implicated in the RTW process on many levels for men and women alike. Further examination of the work reintegration processes that takes gender into account is necessary for the development of successful policy and practice for RTW after work-related MTBI.

Return-to-work challenges following a work-related mild TBI: The injured worker perspective.

PRIMARY OBJECTIVE: To explore how individuals with work-related mild traumatic brain injury (wrMTBI) experience return-to-work (RTW) processes when returning to the workplace where the injury occurred. DESIGN: RTW experiences were explored using in-depth interviews and an inductive analytic approach. Qualitative analysis guided by the research question moved through phases of line-by-line and thematic coding through which categories and the interaction between categories emerged. PARTICIPANTS: Twelve workers diagnosed with a wrMTBI reported on their RTW experiences following wrMTBIs that occurred 3-5 years prior to the time of the interview. MAIN OUTCOMES AND RESULTS: Participants perceived employer and workers' compensation factors as profoundly influencing their RTW experiences. Participants consistently reported that employers and workers' compensation representatives had an inadequate understanding of wrMTBI sequelae. Six of 12 participants were re-injured following their wrMTBI, with three of these injuries occurring at work. CONCLUSION: Employers, co-workers and workers' compensation representatives should be aware of wrMTBI sequelae so injured workers can receive appropriate supports and both stigmatization and re-injury can be mitigated. Greater attention to the structural and social elements of workplace and compensation environments could inform strategies to break down barriers to successful return-to-work following a wrMTBI.

A surveillance tool to assess diets according to Eating Well with Canada's Food Guide.

BACKGROUND: A surveillance tool was developed to assess dietary intake collected by surveys in relation to Eating Well with Canada's Food Guide (CFG). The tool classifies foods in the Canadian Nutrient File (CNF) according to how closely they reflect CFG. This paper describes the validation exercise conducted to ensure that CNF foods determined to be "in line with CFG" were appropriately classified. DATA AND METHODS: With statistical modelling, 8,000 simulated diets (500 for each of the 16 Dietary Reference Intake [DRI] age/sex groups) were generated using commonly consumed foods classified as "in line with CFG." Criteria for assessing the energy content and nutrient distributions of the simulated diets were based on factors considered in the development of CFG, including Estimated Energy Requirement (EER) and Dietary Reference Intake (DRI) values. RESULTS: The median energy content of the simulated diets was at or below reference EERs. Most age/sex group distributions had macronutrient profiles that met the assessment criterion of 80% of the distribution within the Acceptable Macronutrient Distribution Range, and almost all age/sex group distributions had a low prevalence (less than 10%) of micronutrient profiles below the Estimated Average Requirements. Overall, the findings indicate that diets consisting of foods that are commonly consumed by Canadians and that are "in line with CFG" have a low probability of energy excess and nutrient inadequacy. INTERPRETATION: The classification of foods in the CNF accurately reflects CFG recommendations and can be used to assess surveillance data.

Injured workers' perspectives on how workplace accommodations are conceptualized and delivered following electrical injuries.

PURPOSE: Returning to work following an electrical injury can be challenging due to the confluence of physical, cognitive and emotional impairments. Workplace accommodations can facilitate return to work. However, while electrical injuries can have potentially devastating consequences, there is a dearth of understanding of how workplace accommodations are obtained following electrical injury. This paper explores workers' experiences of returning to work and accommodations following an occupation electrical injury. METHODS: Thirteen semi-structured qualitative telephone interviews were conducted with injured workers recruited from acute and rehabilitation burns programs in Ontario, Canada. Thematic analysis was employed to identify themes related to the request and provision of accommodations. FINDINGS: Findings reveal that accommodations are most frequently narrowly defined in relation to physical work restrictions, leading to the exclusion of cognitive and psychosocial concerns. Challenges within the accommodations process such as perceived legitimacy, a do-it-yourself approach to accommodations, and concerns regarding job security can also influence workers' decisions to request accommodations. Process elements that facilitate the effective provision of workplace accommodations include: (1) finding a "just right" fit between workers' abilities and assigned tasks and duties (2) establishing effective lines of communication between relevant stakeholders; (3) prompt response to needs; (4) having a knowledgeable individual in a position of power to advocate on workers' behalf. CONCLUSIONS: Further education regarding electrical injuries and workplace accommodations is warranted to increase workers', employers', health and insurance personnels' knowledge about electrical injury and best practices for providing workplace accommodations.

After the storm: the social relations of return to work following electrical injury.

In this study, we explored the experiences of 13 individuals who had suffered an electrical injury at work and had subsequently returned to work. In this article, we report on the social, institutional, and relational elements that workers perceived to influence return to work experiences and the provision of workplace accommodations. These elements included (a) worker resources, (b) job characteristics, (c) workplace setting, (d) injury elements, (e) workers' compensation context, and (f) supports and advocacy provided. We conclude that the availability and provision of supportive accommodations are influenced by a multiplicity of interrelated factors including the legitimacy of resulting impairments following electrical injury, institutional structures (e.g., compensation and health care systems), the social relations of work, and broader labor market and economic contexts. Those workers who were vulnerable because of factors such as employment circumstances or labor market conditions were often poorly supported when returning to work following electrical injury.

Digital storytelling online: a case report exploring virtual design, implementation opportunities and challenges.

BACKGROUND: Digital storytelling is an arts-informed approach that engages short, first-person videos, typically three to five minutes in length, to communicate a personal narrative. Prior to the pandemic, digital storytelling initiatives in health services research were often conducted during face-to-face workshops scheduled over multiple days. However, throughout the COVID-19 lockdowns where social distancing requirements needed to be maintained, many digital storytelling projects were adapted to online platforms. METHODS: As part of a research project aiming to explore the day surgery treatment and recovery experiences of women with breast cancer in Peel region, we decided to pivot our digital storytelling process to an online format. During the process, we observed that the online digital storytelling format had multiple opportunities and challenges to implementation. RESULTS: This paper outlines our promising practices and lessons learned when designing and implementing an online digital storytelling project including pre-production, production and post-production considerations. CONCLUSIONS: We provide lessons learned for future teams intending to conduct an online digital storytelling project.

Digital storytelling uses pictures, video clips and audio to create a short, first-person video, to share a person's story. Before the pandemic, digital storytelling workshops were often held in-person over multiple days to help members of the community create their own digital stories. However, throughout COVID-19, many digital storytelling workshops were held online instead. This paper outlines our lessons learned when hosting an online digital storytelling workshop series to capture women's experiences with breast cancer in our local community. We hope our lessons learned are helpful for other teams who are considering using online digital storytelling workshops for their own research projects.

"I Am the Last Priority": Factors Influencing Diabetes Management Among South Asian Caregivers in Peel Region, Ontario.

OBJECTIVE: In this study, we aimed to identify sociocultural and systemic factors influencing diabetes management among South Asian (SA) caregivers in Peel Region, Ontario. METHODS: Twenty-one semistructured interviews were conducted with SA caregivers using a qualitative descriptive design. Data were analyzed using thematic analysis and intersectionality analysis. RESULTS: Themes identified included 1) prioritizing family caregiving over diabetes self-management; 2) labour market impacts on diabetes self-management; and 3) challenges navigating Canadian health and social service systems. SA caregivers described social, economic, and systemic challenges impacting type 2 diabetes management. Systemic factors influencing diabetes management included discrimination and inequities in labour policies and lack of social and health resources funding. Recommendations by caregivers included whole-family, community-based, culturally tailored approaches to diabetes prevention and management strategies. CONCLUSIONS: Providing support with system navigation, encouraging family-based approaches, and addressing the social determinants of health could be beneficial for supporting SA families with diabetes management and prevention.

Statistical design for biospecimen cohort size in proteomics-based biomarker discovery and verification studies.

Protein biomarkers are needed to deepen our understanding of cancer biology and to improve our ability to diagnose, monitor, and treat cancers. Important analytical and clinical hurdles must be overcome to allow the most promising protein biomarker candidates to advance into clinical validation studies. Although contemporary proteomics technologies support the measurement of large numbers of proteins in individual clinical specimens, sample throughput remains comparatively low. This problem is amplified in typical clinical proteomics research studies, which routinely suffer from a lack of proper experimental design, resulting in analysis of too few biospecimens to achieve adequate statistical power at each stage of a biomarker pipeline. To address this critical shortcoming, a joint workshop was held by the National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), and American Association for Clinical Chemistry (AACC) with participation from the U.S. Food and Drug Administration (FDA). An important output from the workshop was a statistical framework for the design of biomarker discovery and verification studies. Herein, we describe the use of quantitative clinical judgments to set statistical criteria for clinical relevance and the development of an approach to calculate biospecimen sample size for proteomic studies in discovery and verification stages prior to clinical validation stage. This represents a first step toward building a consensus on quantitative criteria for statistical design of proteomics biomarker discovery and verification research.

Continuing to strengthen FDA's science approach to emerging technologies.

Emerging technologies result when advances and innovation in technology lead to discoveries. Often emerging technologies stimulate novel research in medical product development that contribute to new approaches to manufacturing and can improve the quality of products. By supporting investments in agency coordination, staff training and professional development, regulatory science research, stakeholder engagement, and enhancing opportunities for expert input, the U.S. Food and Drug Administration plays a critical role in translating innovations into novel safe and effective medical products that improve the public health.

A risk-based labelling strategy for supplemented foods in Canada: consumer perspectives.

NOVELTY: Risk-based labelling strategy for supplemented foods Strategy goes beyond the general requirements for prepackaged foods.

The Perceived Ease of Use and Perceived Usefulness of a Web-Based Interprofessional Communication and Collaboration Platform in the Hospital Setting: Interview Study With Health Care Providers.

BACKGROUND: Hospitalized patients with complex care needs require an interprofessional team of health professionals working together to support their care in hospitals and during discharge planning. However, interprofessional communication and collaboration in inpatient settings are often fragmented and inefficient, leading to poor patient outcomes and provider frustration. Health information technology can potentially help improve team communication and collaboration; however, to date, evidence of its effectiveness is lacking. There are also concerns that current implementations might further fragment communication and increase the clinician burden without proven benefits. OBJECTIVE: In this study, we aimed to generate transferrable lessons for future designers of health information technology tools that facilitate team communication and collaboration. METHODS: A secondary analysis of the qualitative component of the mixed methods evaluation was performed. The electronic communication and collaboration platform was implemented in 2 general internal medicine wards in a large community teaching hospital in Mississauga, Ontario, Canada. Fifteen inpatient clinicians in those wards, including nurses, physicians, and allied health care providers, were recruited to participate in semistructured interviews about their experience with a co-designed electronic communication and collaboration tool. Data were analyzed using the Technology Acceptance Model, and themes related to the constructs of perceived ease of use (PEOU) and perceived usefulness (PU) were identified. RESULTS: A secondary analysis guided by the Technology Acceptance Model highlighted important points. Intuitive design precluded training as a barrier to use, but lack of training may hinder participants' PEOU if features designed for efficiency are not discovered by users. Organized information was found to be useful for creating a comprehensive clinical picture of each patient and facilitating improved handovers. However, information needs to be both comprehensive and succinct, and information overload may negatively impact PEOU. The mixed paper and electronic practice environment also negatively impacted PEOU owing to unavoidable double documentation and the need for printing. Participants perceived the tool to be useful as it improved efficiency in information retrieval and documentation, improved the handover process, afforded another mode of communication when face-to-face communication was impractical, and improved shared awareness. The PU of this tool depends on its optimal use by all team members. CONCLUSIONS: Electronic tools can support communication and collaboration among interprofessional teams caring for patients with complex needs. There are transferable lessons learned that can improve the PU and PEOU of future systems.

Individual, social and environmental factors influencing physical activity levels and behaviours of multiethnic socio-economically disadvantaged urban mothers in Canada: a mixed methods approach.

BACKGROUND: Existing data provide little insight into the physical activity context of multiethnic socio-economically disadvantaged mothers in Canada. Our primary objectives were: (1) to use focus group methodology to develop tools to identify the individual, social, and environmental factors influencing utilitarian and leisure time physical activities (LTPA) of multiethnic SED mothers; and (2) to use a women specific physical activity survey tool to assess psychosocial barriers and supports and to quantify individual physical activity (PA) levels of multi-ethnic SED mothers in Canada. METHODS: Qualitative focus group sessions were conducted in West, Central and Eastern Canada with multiethnic SED mothers (n = 6 focus groups; n = 42 SED mothers) and with health and recreation professionals (HRPs) (n = 5 focus groups; n = 25 HRPs) involved in community PA programming for multiethnic SED mothers. Administration of the women specific Kaiser Physical Activity Survey (KPAS) tool was completed by consenting SED mothers (n = 59). RESULTS: More than half of SED mothers were employed and had higher total PA scores with occupation included than unemployed mothers. However, nearly 60% of both groups were overweight or obese. Barriers to LTPA included the lack of available, affordable and accessible LTPA programs that responded to cultural and social needs. Concerns for safety, nonsupportive cultural and social norms and the winter climate were identified as key barriers to both utilitarian and LTPA. CONCLUSIONS: Findings show that multiethnic SED mothers experience many barriers to utilitarian and LTPA opportunities within their communities. The varying LTPA levels among these multi-ethnic SED mothers and the occurrence of overweight and obesity suggests that current LTPA programs are likely insufficient to maintain healthy body weights.

Service Provider Perspectives on Exploring Social Determinants of Health Impacting Type 2 Diabetes Management for South Asian Adults in Peel Region, Canada.

OBJECTIVES: Individuals from South Asian communities are known to have a higher likelihood of developing type 2 diabetes (T2D), which is often attributed to individual lifestyle and behavioural factors. This focus on individual responsibility can position communities as complicit in their illness, compounding stigmatization and systemic discrimination. In this article, we explore the social determinants of health (SDOH) that influence health behaviours among South Asian adults with T2D from a service provider's perspective. METHODS: Using a qualitative descriptive design, we conducted semistructured interviews with 12 community, social and health-care service providers. We used thematic analysis and the analytical concept of intersectionality to explore how different social locations and SDOH impact T2D management for South Asian adults. RESULTS: Three themes were identified: 1) managing challenges with settlement process, labour policies and job market disparities take priority over T2D management; 2) poor working conditions and low socioeconomic status reduce access to health care and medication; and 3) there are social, economic and cultural barriers to implementing diet and exercise recommendations. CONCLUSIONS: Service providers identified social, economic and systemic factors as influencing the higher prevalence of T2D among South Asian individuals. They also identified their important roles in providing culturally appropriate supports to address SDOH and described advocacy for changes to policies and practices that reinforce systemic racism. The providers further suggested that more equitable employment policies and practices are needed to address the systemic factors that contribute to the higher risk of T2D among South Asian adults in the Peel Region.

Biospecimen reporting for improved study quality (BRISQ).

Human biospecimens are subject to a number of different collection, processing, and storage factors that can significantly alter their molecular composition and consistency. These biospecimen preanalytical factors, in turn, influence experimental outcomes and the ability to reproduce scientific results. Currently, the extent and type of information specific to the biospecimen preanalytical conditions reported in scientific publications and regulatory submissions varies widely. To improve the quality of research utilizing human tissues, it is critical that information regarding the handling of biospecimens be reported in a thorough, accurate, and standardized manner. The Biospecimen Reporting for Improved Study Quality (BRISQ) recommendations outlined herein are intended to apply to any study in which human biospecimens are used. The purpose of reporting these details is to supply others, from researchers to regulators, with more consistent and standardized information to better evaluate, interpret, compare, and reproduce the experimental results. The BRISQ guidelines are proposed as an important and timely resource tool to strengthen communication and publications around biospecimen-related research and help reassure patient contributors and the advocacy community that the contributions are valued and respected.

The journey to regulation of protein-based multiplex quantitative assays.

BACKGROUND: Clinical proteomics presents great promise in biology and medicine because of its potential for improving our understanding of diseases at the molecular level and for detecting disease-related biomarkers for diagnosis, prognosis, and prediction of therapeutic responses. To realize its full potential to improve clinical outcome for patients, proteomic studies have to be well designed, from biosample cohorts to data and statistical analyses. One key component in the biomarker development pipeline is the understanding of the regulatory science that evaluates diagnostic assay performance through rigorous analytical and clinical review criteria. CONTENT: The National Cancer Institute's Clinical Proteomic Technologies for Cancer (CPTC) initiative has proposed an intermediate preclinical "verification" step to close the gap between protein-based biomarker discovery and clinical qualification. In collaboration with the US Food and Drug Administration (FDA), the CPTC network investigators recently published 2 mock submission review documents, first-of-their-kind educational materials that may help the scientific community interested in developing products for the clinic in understanding the likely analytical evaluation requirements for multiplex protein technology-based diagnostic tests. CONCLUSIONS: Building on this momentum, the CPTC continues with this report its collaboration with the FDA, as well as its interactions with the AACC and the Centers for Medicare and Medicaid Services, to further the understanding of regulatory requirements for approving multiplex proteomic platform-based tests and analytically validating multiple analytes.