Using real-world data to accelerate the search for long COVID therapies.

Long COVID, a spectrum of symptoms and syndromes that can develop after SARS-COV-2 infection, can significantly affect patients' health, quality of life and impact their ability to productively function in society. There is currently no approved therapy for Long COVID and there is an urgent need for rigorous clinical trials to find such treatments. Although research into the pathophysiology of Long COVID is advancing, investigations into treatment for patients remain underfunded and, as a result, understudied. Owing to the urgency of the Long COVID pandemic and as a research collaborative across a diversity of biomedical innovation value propositions, we are calling for a new approach that parallelizes pathophysiologic and therapeutic research into this condition, leveraging patient-centered research and real-world data to generate hypotheses to assess the effectiveness of existing FDA approved drugs. Accelerated discovery of therapeutics for Long COVID can then be confirmed through efficient and cost-effective adaptive platform clinical trials.

A mixed-methods analysis of moral injury among healthcare workers during the COVID-19 pandemic.

During the COVID-19 pandemic, healthcare workers faced grave responsibilities amidst rapidly changing policies and material and staffing shortages. Moral injury, psychological distress following events where actions transgress moral beliefs/ expectations, increased among healthcare workers. We used a sequential mixed methods approach to examine workplace and contextual factors related to moral injury early in the pandemic. Using a Total Worker Health® framework, we 1) examined factors associated with moral injury among active healthcare professionals (N = 14,145) surveyed between May-August 2020 and 2) qualitatively analyzed open-ended responses from 95 randomly selected participants who endorsed moral injury on the survey. Compared to inpatient hospital, outpatient (OR = 0.74 [0.65, 0.85]) or school clinic settings (OR = 0.37 [0.18, 0.75]) were associated with lower odds of moral injury; while group care settings increased odds (OR = 1.36 [1.07, 1.74]). Working with COVID+ patients (confirmed+ OR = 1.27 [1.03, 1.55]), PPE inadequacy (OR = 1.54 [1.27, 1.87]), and greater role conflict (OR = 1.57 [1.53, 1.62]) were associated with greater odds of moral injury. Qualitative findings illustrate how outside factors as well as organizational policies and working conditions influenced moral injury. Moral injury experiences affected staff turnover and patient care, potentially producing additional morally injurious effects. Worker- and patient-centered organizational policies are needed to prevent moral injury among healthcare workers. The generalizability of these findings may be limited by our predominantly white and female sample. Further research is indicated to replicate these findings in minoritized samples.

Promoting equity, diversity, and inclusion in surveys: insights from a patient-engaged study to assess long COVID health-care needs in Brazil.

BACKGROUND AND OBJECTIVE: Long COVID (LC) refers to persistent symptoms after acute COVID-19 infection, which may persist for months or years. LC affects millions of people globally, with substantial impacts on quality of life, employment, and social participation. Ensuring access to effective, patient-centered care for LC demands evidence, grounded in inclusive representation of those affected by the condition. Yet survey studies frequently under-represent people with the most disabling disease presentations and racially and socioeconomically marginalized groups. We aimed to describe a patient-engaged approach to developing a survey to inform public LC health care and to assess its implementation in terms of enabling participation by diverse LC patients in Brazil. METHODS: Survey development was iterative, achieved through an interdisciplinary collaboration among researchers including people living with LC, and grounded in 3 guiding principles: (1) evidence-based; (2) inclusive, intersectional, and patient-centered understanding of chronic illness and research participation; and (3) sensitivity to the context of health-care access. RESULTS: The product of our collaboration was a longitudinal survey using a questionnaire assessing: LC symptoms; their clinical and functional evolution; and impacts on quality of life, household income, health service access, utilization, and out-of-pocket expenses. We illustrate how we operationalized our 3 principles through survey content, instrument design, and administration. Six hundred fifty-one participants with diverse LC symptoms, demography, and socioeconomic status completed the survey. We successfully included participants experiencing disabling symptoms, Black and mixed race participants, and those with lower education and income. CONCLUSION: By centering patient experience, our novel, principles-based approach succeeded in promoting equity, diversity, and inclusion in LC survey research. These principles guiding patient-engaged collaboration have broad transferability. We encourage survey researchers working on chronic illness and in other contexts of marginalization and inequality to adopt them.

Adding injury to insult: Unfair treatment at work and occupational injury among hospital patient-care workers.

BACKGROUND: Hospital patient-care workers have high occupational injury rates. While physical hazards within hospital work environments are established determinants of injury, social exposures may also contribute. This study examined how reports of unfair treatment at work, a dimension of work-related experiences of discrimination, were associated with injury among hospital-based patient-care workers. METHODS: We used data from the Boston Hospital Workers Health Study, a longitudinal cohort of nurses and nursing assistants at two Boston-area hospitals. In 2018, we conducted a worker survey asking about three types of unfair treatment at work and occupational injuries during the past year. We used mixed-effects logistic regression models to evaluate associations between specific types, total load, and high-frequency exposure of unfair treatment with injury, adjusting for age, gender, race and ethnicity, job title, and unit type. RESULTS: Among 1001 respondents, 21% reported being humiliated in front of others at work, 28% reported being watched more closely than other workers, and 47% reported having to work twice as hard as others for the same treatment. For each type of unfair treatment, we observed a monotonic relationship with occupational injury wherein increasing frequency of exposure was associated with increased odds of injury. We also observed monotonic relationships between total load and high-frequency exposure to unfair treatment and odds of injury. CONCLUSIONS: Work-related unfair treatment is associated with injury among hospital workers. Programs and policies that focus on preventing unfair treatment may lessen injury burden in hospital workers.

Return-to-work with long COVID: An Episodic Disability and Total Worker Health® analysis.

A growing number of working individuals have developed long COVID (LC) after COVID-19 infection. Economic analyses indicate that workers' LC symptoms contribute to workforce shortages. However, factors that affect return-to-work from perspectives of people with LC remain largely underexplored. This qualitative study of people with LC conducted by researchers living with LC aimed to identify participants' return-to-work experiences using Total Worker Health® and Episodic Disability frameworks. 10% of participants who participated in a mixed-method global internet survey, had LC symptoms >3 months, and responded in English were randomly selected for thematic analysis using NVivo12. 15% of responses were independently double-coded to identify coding discrepancies. Participants (N = 510) were predominately white and had at least a baccalaureate degree. Four primary work-related themes emerged: 1) strong desire and need to return to work motivated by sense of purpose and financial precarity; 2) diverse and episodic LC symptoms intersect with organization of work and home life; 3) pervasiveness of LC disbelief and stigma at work and in medical settings; and 4) support of medical providers is key to successful return-to-work. Participants described how fluctuation of symptoms, exacerbated by work-related tasks, made returning to work challenging. Participants' ability to work was often predicated on job accommodations and support. Non-work factors were also essential, especially being able to receive an LC medical diagnosis (key to accessing leave and accommodations) and help at home to manage non-work activities. Many participants described barriers accessing these supports, illuminating stigma and disbelief in LC as a medical condition. Qualitative findings indicate needs for workplace accommodations tailored to fluctuating symptoms, continuously re-evaluated by workers and supervisors together. Reductions in medical barriers to access work accommodations is also critical since many medical providers remain unaware of LC, and workers may lack a positive COVID test result.

Residential addiction treatment providers: Identifying the role of social context in worker health and turnover.

Increased lethality and availability of addictive substances has strained US addiction treatment services, further exacerbating workforce shortages in these settings. The emotional and physical health toll of providing treatment may contribute to shortages. This community-initiated qualitative study aimed to identify conditions that affect provider health and turnover in residential addiction treatment from a Total Worker Health® perspective. Providers (direct service, supervisors, leaders) working in nonprofit residential treatment facilities in Massachusetts were recruited by role and geography to participate in interviews and focus groups. NVivo12 facilitated coding and analysis. 25% of transcripts were double coded to assess interrater reliability and coding consistency (mean Kappa = 0.82). Providers (N = 49) participated in 33 interviews and 4 focus groups. Many participants reported personal addiction histories. Analysis revealed how socio-contextual factors originating outside of residential facilities were dominant influences on "downstream" working conditions, worker health, staff turnover, and by extension, client care. Four primary socio-contextual themes surfaced:1) Changes in type and potency of substances and client need not reliably accompanied by shifts in treatment practices; 2) challenges balancing state requirements and state-provided resources; 3) influence of structural discrimination and addiction stigma on pay and professional advancement; and 4) geographic location of facilities shape work and quality of life. Results were used to develop a conceptual model for residential addiction treatment to illustrate pathways by which ecological factors interact to affect provider health and turnover. Findings indicate that protecting health and wellbeing of providers-many of whom are in addiction recovery themselves- is integral to improving addiction treatment. From this workforce's perspective, recent changes in socio-contextual factors have intensified already challenging working conditions (job demands, pay, advancement), negatively impacting worker health, turnover, and client care. Any interventions to improve treatment outcomes or working conditions in nonprofit addiction facilities must consider larger socio-contextual factors influencing these organizations.

Implementation of an organizational intervention to improve low-wage food service workers' safety, health and wellbeing: findings from the Workplace Organizational Health Study.

BACKGROUND: Many organizational interventions aim to improve working conditions to promote and protect worker safety, health, and well-being. The Workplace Organizational Health Study used process evaluation to examine factors influencing implementation of an organizational intervention. This paper examines the extent to which the intervention was implemented as planned, the dose of intervention implemented, and ways the organizational context hindered or facilitated the implementation of the intervention. METHODS: This proof-of-concept trial was conducted with a large, multinational company that provides food service through contractual arrangements with corporate clients. The 13-month intervention was launched in five intervention sites in October 2018. We report findings on intervention implementation based on process tracking and qualitative data. Qualitative data from 25 post-intervention interviews and 89 process tracking documents were coded and thematically analyzed. RESULTS: Over the 13-month intervention, research team representatives met with site managers monthly to provide consultation and technical assistance on safety and ergonomics, work intensity, and job enrichment. Approximately two-thirds of the planned in-person or phone contacts occurred. We tailored the intervention to each site as we learned more about context, work demands, and relationships. The research team additionally met regularly with senior leadership and district managers, who provided corporate resources and guidance. By assessing the context of the food service setting in which the intervention was situated, we explored factors hindering and facilitating the implementation of the intervention. The financial pressures, competing priorities and the fast-paced work environment placed constraints on site managers' availability and limited the full implementation of the intervention. CONCLUSIONS: Despite strong support from corporate senior leadership, we encountered barriers in the implementation of the planned intervention at the worksite and district levels. These included financial demands that drove work intensity; turnover of site and district managers disrupting continuity in the implementation of the intervention; and staffing constraints that further increased the work load and pace. Findings underscore the need for ongoing commitment and support from both the parent employer and the host client. TRIAL REGISTRATION: This study was retrospectively registered with the Clinical Trials. Gov Protocol and Results System on June 2, 2021 with assigned registration number NCT04913168 .

Using Total Worker Health® Implementation Guidelines to Design an Organizational Intervention for Low-Wage Food Service Workers: The Workplace Organizational Health Study.

Total Worker Health® (TWH) interventions that utilize integrated approaches to advance worker safety, health, and well-being can be challenging to design and implement in practice. This may be especially true for the food service industry, characterized by high levels of injury and turnover. This paper illustrates how we used TWH Implementation Guidelines to develop and implement an organizational intervention to improve pain, injury, and well-being among low-wage food service workers. We used the Guidelines to develop the intervention in two main ways: first, we used the six key characteristics of an integrated approach (leadership commitment; participation; positive working conditions; collaborative strategies; adherence; data-driven change) to create the foundation of the intervention; second, we used the four stages to guide integrated intervention planning. For each stage (engaging collaborators; planning; implementing; evaluating for improvement), the Guidelines provided a flexible and iterative process to plan the intervention to improve safety and ergonomics, work intensity, and job enrichment. This paper provides a real-world example of how the Guidelines can be used to develop a complex TWH intervention for food service workers that is responsive to organizational context and addresses targeted working conditions. Application of the Guidelines is likely transferable to other industries.

Consensus agreement to rename burning mouth syndrome and improve International Classification of Diseases-11 disease criteria: an international Delphi study.

ABSTRACT: The International Classification of Diseases (ICD-11) proposes revisions in the nomenclature, disease definition, and diagnostic criteria for "burning mouth syndrome" (BMS). This process could benefit from additional systematically collected expert input. Thus, the purpose of this study was to use the Delphi method to (1) determine whether revision in nomenclature and alternative names for "BMS" are warranted and (2) identify areas of consensus among experts for changes to the disease description and proposed diagnostic criteria of "BMS," as described in the ICD-11 (World Health Organization). From 31 international invited experts, 23 who expressed interest were sent the survey. The study used 4 iterative surveys, each with a response rate of ≥82%. Consensus was predefined as 70% of participants in agreement. Data were summarized using both descriptive statistics and qualitative thematic analysis. Consensus indicated that BMS should not be classified as a syndrome and recommended instead renaming to "burning mouth disorder." Consensus included deletion of 2 diagnostic criteria: (1) emotional distress or functional disability and (2) the number of hours symptoms occur per day. Additional items that reached consensus clarified the disease definition and proposed more separate diagnostic criteria, including a list of local and systemic factors to evaluate as potential secondary causes of oral burning. Experts in this study recommended and came to consensus on select revisions to the proposed ICD-11 BMS nomenclature, diagnostic criteria, and disease definition. The revisions recommended have the potential to improve clarity, consistency, and accuracy of diagnosis for this disorder.

COVID and Camus: Reflections on The Plague, collective experience, and qualitative inquiry during a pandemic.

As a social worker and qualitative researcher, I read Albert Camus's The Plague as I lay recovering from COVID-19. The existential novella documents the experience of the citizens of Oran, Algeria during a fictional epidemic, and The Narrator's documentation is explicitly based on qualitative "data" from participant observation, key informant accounts, and document analysis. Camus's text forces the reader to reflect on what it means to qualitatively study an issue or an event when the researcher is also affected by it. Just as readers of The Plague must ponder the objectives and interpretation of The Narrator who is "closely involved in all that he proposed to narrate," qualitative researchers must contemplate their own assumptions, aims, and subjectivity, which is both foundational and often overlooked in qualitative inquiry. While this is particularly critical when studying shared or collective experiences, like that of a pandemic, these assumptions and aims should always be made transparent in qualitative research. To this end, I suggest a series of reflective questions for researchers to iteratively grapple with throughout the research process.

Perspectives on Breastfeeding from Mothers with Postpartum Depression Symptoms: A Qualitative Assessment of Antecedents, Barriers, Facilitators, and Intervention Suggestions.

Background: Postpartum depression (PPD) is one of the most common birthing complications, and studies negatively associate PPD with breastfeeding initiation and continuation. However, little is known about either the breastfeeding experience of mothers with PPD or what resources mothers need for sustained breastfeeding from their perspectives. This study aimed to identify the antecedents, barriers, and facilitators to breastfeeding for mothers with PPD, understand the relationship between self-efficacy and emergent themes, and generate suggestions to inform supportive interventions. Materials and Methods: Birth mothers who screened positive for PPD and reported breastfeeding were recruited to participate in semistructured interviews. Interviews were transcribed verbatim, and inter-coder discrepancies from double coding were resolved through consensus. Thematic analysis was facilitated using immersion-crystallization methods. Results: Participants identified five antecedent themes that encourage initiation (professional support, infant health, mother's health, cost-effectiveness, and faith), four facilitator themes for sustained breastfeeding (infant connection, decreased stress, personal attributes, and logistical strategies), and seven barrier themes (physical pain, infant nutrition, negative feelings, latching difficulties, medical conditions, public breastfeeding, and sleep). Participants' suggestions fell into three primary themes: supportive services, managing expectations, and respecting self-determination. Conclusion: Antecedent and facilitator themes did not overlap, indicating that factors encouraging breastfeeding initiation differ from sustaining factors. Participant suggestions, barriers, and facilitators did not largely differ from mothers without PPD in other qualitative studies. Therefore, interventions should tailor support to specific breastfeeding phase and may not need to be markedly different for mothers with PPD, in addition to depression management.

Engaging parent-child dyad and healthcare provider stakeholders in a patient-centered comparative effectiveness study.

Aim: Describe engagement activities in a comparative effectiveness study evaluating two interventions for promoting psychosocial health among youth ages 10-17 who have recently experienced a nonintentional injury. Methods: Institutional, community and patient stakeholders from four children's hospitals were engaged through consultation meetings, individual interviews and a collaborative meeting. Results: 67 engagement activities were conducted across four hospitals. Feedback to improve recruitment, retention and continuous engagement in the study was obtained. Finally, disseminating study interventions to school and healthcare settings, and adding alternative delivery formats were identified as priority next steps. Conclusion: Results highlight diverse methods of engaging patient and professional stakeholders, critical recommendations for improving study engagement and retention, and future directions for this patient-engaged comparative effectiveness research.

Social Determinants of Health and What Mothers Say They Need and Want After Release From Jail.

Identifying the biopsychosocial needs of mothers who have been released from jail is critical to understanding the best ways to support their health and stability after release. In May through August 2014, we interviewed 15 mothers who had been released from an urban jail about their reentry experiences, and we analyzed transcripts for themes. Eight domains of community reentry emerged through analysis: behavioral health services, education, employment, housing, material resources, medical care, relationships with children, and social support. Participants defined barriers to successful reentry, which paralleled the social determinants of health, and shared suggestions that could be used to mitigate these barriers.

Perceptions of Family Participation in Intensive Care Unit Rounds and Telemedicine: A Qualitative Assessment.

BACKGROUND: Family-centered rounds involve purposeful interactions between patients' families and care providers to refocus the delivery of care on patients' needs. OBJECTIVES: To examine perspectives of patients' family members and health care providers on family participation in rounds in the surgical intensive care unit (ICU) and the potential use of telemedicine to facilitate this process. METHODS: Patients' family members and surgical ICU care providers were recruited for semistructured interviews exploring stakeholders' perspectives on family participation in ICU rounds and the potential role of telemedicine. Thirty-two interviews were conducted, audio recorded, and transcribed verbatim. Common coding methods were facilitated by using NVivo 10. A mean coding agreement of 97.3% was calculated for 22% of transcripts. RESULTS: Both patients' family members and health care providers described inconsistent practices surrounding family participation in ICU rounds as well as barriers to and facilitators of family participation. Family members identified 3 primary logistical challenges to participation in ICU rounds: distance to hospitals, work/family obligations, and the rounding schedule. Both family members and providers reported receptivity to virtual participation as a potential solution to these challenges. CONCLUSIONS: Understanding the barriers to and facilitators of family participation in ICU rounds is key to encouraging adoption of family-centered rounds. For families that live far away or have competing demands, telemedical options may facilitate participation.