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Evaluation and randomised controlled trial of home urinalysis testing in patients with SLE at elevated risk for developing lupus nephritis: a study protocol

Gold, Heather T; El Shahawy, Omar; Izmirly, Peter M; Masson, Mala; Cohen, Brooke; Buyon, Jill P
INTRODUCTION/BACKGROUND:Lupus nephritis (LN) is a frequent complication of SLE, occurring in up to 60% of adult patients and ultimately progressing from acute inflammation to chronicity with fibrosis and end-stage kidney failure in 10%-30% of patients. Racial/ethnic minority patients with lupus have worse long-term outcomes, including progression to end-stage renal disease and overall mortality. A major challenge in the management of patients with SLE is delayed identification of early kidney disease, which ultimately leads to a greater burden on both patients and the health system. METHODS AND ANALYSIS/METHODS:Using a mixed methods approach, this study will develop, adapt and evaluate a home urine sampling protocol with a text-messaging reminder and data capture system for patients at elevated risk of de novo LN or relapse. First, a feasibility pilot using a single-group trial design (n=18) will be implemented, with a feasibility assessment and qualitative, debriefing interviews with patients to further refine the intervention. The second phase is a comparative effectiveness trial of the intervention (n=160) with the primary outcome of biopsy eligibility, that is, the participant has a clinical indication for a kidney biopsy (urine protein-creatinine ratio≥0.5), whether or not the patient actually undergoes the biopsy procedure. The randomised trial includes an economic evaluation of the adapted home urinalysis protocol. DISCUSSION AND DISSEMINATION/CONCLUSIONS:It is unknown whether weekly home-based urine sampling can identify proteinuria sooner than standard care; if found sooner, kidney problems could be diagnosed earlier, hopefully leading to earlier care for less-involved disease and subsequent reduced morbidity. The data collected in this trial will inform future feasibility and effectiveness of text-messaging-based home urine sampling interventions. TRIAL REGISTRATION NUMBER/BACKGROUND:The randomised trial will be registered with ClincialTrials.gov prior to enrolment start.
PMCID:11590779
PMID: 39578016
ISSN: 2053-8790
CID: 5758982

Strengthening policy engagement when scaling up interventions targeting non-communicable diseases: insights from a qualitative study across 20 countries

Ramani-Chander, Anusha; Thrift, Amanda G; van Olmen, Josefien; Wouters, Edwin; Delobelle, Peter; Vedanthan, Rajesh; Miranda, J Jaime; De Neve, Jan-Walter; Esandi, Maria Eugenia; Koot, Jaap; Ojji, Dike; Ortiz, Zulma; R Sherwood, Stephen; Teede, Helena; Joshi, Rohina
Policy engagement is an essential component of implementation research for scaling up interventions targeting non-communicable diseases (NCDs). It refers to the many ways that research team members, implementers and policymakers, who represent government decision-making, connect and interact to explore common interests. Well-conducted engagement activities foster co-production, local contextualization and assist in the successful translation of research evidence into policy and practice. We aimed to identify the challenges and facilitators to policy engagement during the early implementation phase of scale-up research studies. This qualitative study was focused on the research projects that were funded through the Global Alliance for Chronic Diseases in the 2019 round. Nineteen project teams opted to participate, with these studies implemented in 20 countries. Forty-three semi-structured stakeholder interviews, representing research, implementation and government were undertaken between August 2020 and July 2021. Transcripts were open-coded using thematic analysis to extract 63 codes which generated 15 themes reflecting both challenges and facilitators to undertaking policy engagement. Knowledge of the local government structures and trusting relationships provided the foundation for successful engagement and were strengthened by the research. Four cross-cutting concepts for engagement were identified and included: (1) the importance of understanding the policy landscape; (2) facilitating a network of suitable policy champions, (3) providing an environment for policy leaders to genuinely contribute to co-creation and (4) promoting two-way learning during researcher-policymaker engagement. We recommend undertaking formative policy analysis to gain a strategic understanding of the policy landscape and develop targeted engagement plans. Through engagement, researchers must facilitate cohesive vision and build a team of policy champions to advocate NCD research within their networks and spheres of influence. Ensuring equitable partnerships is essential for enabling local ownership and leadership. Further, engagement efforts must create a synergistic policymaker-researcher lens to promote the uptake of evidence into policy.
PMCID:11570794
PMID: 39552340
ISSN: 1460-2237
CID: 5757982

Patient experiences in outpatient substance use disorder treatment: A qualitative study exploring both clinical and non-clinical contexts

Choi, Sugy; Choi, Jasmin; O'Grady, Megan; Renteria, Diego; Oueles, Crissy; Liebmann, Eddie; Lincourt, Pat; Jordan, Ashly E; Neighbors, Charles J
BACKGROUND:Addressing the persistent treatment gap in substance use disorder (SUD) remains a critical challenge, with only 13 % of Americans with SUDs receiving necessary treatment. We explored the complexities of engaging in SUD treatment from patients' perspectives and aims to provide a comprehensive understanding of their treatment experiences. METHODS:We conducted semi-structured interviews with 34 patients who had been attending outpatient SUD clinics in New York State for 6 or less months. Participants were recruited from seven clinics using purposive sampling. Interviews were conducted between June and August 2022. We conducted thematic analysis of coded data to explore patients' experiences and preferences while navigating their treatment journeys. RESULTS:Critical elements for a positive treatment experience included cultural humility, confidentiality, consistency, trust, peer counselors with SUD experience, a strong sense of connection, and addressing needs beyond clinical settings. These included assistance with housing and employment, participation in external clinic events, and access to amenities like coffee and snacks. Participants favored holistic treatment approaches integrating mental health and involving peer recovery counselors. However, participants also identified ineffective aspects, including rigid and generic approaches, stigmatizing attitudes, and challenges related to communities and environmental influences. CONCLUSION/CONCLUSIONS:The study highlights the multifaceted nature of outpatient SUD treatment, emphasizing the integration of patient-centered, holistic, and culturally competent approaches. Tailoring interventions to individual circumstances and acknowledging the diverse needs of patients are imperative for effective healthcare practices.
PMID: 39557341
ISSN: 2949-8759
CID: 5758222

Don't Just Look East (the Other Way) When There's Smoke Billowing to the West

Myers, Laura C; Pak, Nina; Balaban, Eric; Thakur, Neeta; Cromar, Kevin
PMCID:11568446
PMID: 39312199
ISSN: 1535-4970
CID: 5802882

Lightening the Load: Generative AI to Mitigate the Burden of the New Era of Obesity Medical Therapy

Stevens, Elizabeth R; Elmaleh-Sachs, Arielle; Lofton, Holly; Mann, Devin M
Highly effective antiobesity and diabetes medications such as glucagon-like peptide 1 (GLP-1) agonists and glucose-dependent insulinotropic polypeptide/GLP-1 (dual) receptor agonists (RAs) have ushered in a new era of treatment of these highly prevalent, morbid conditions that have increased across the globe. However, the rapidly escalating use of GLP-1/dual RA medications is poised to overwhelm an already overburdened health care provider workforce and health care delivery system, stifling its potentially dramatic benefits. Relying on existing systems and resources to address the oncoming rise in GLP-1/dual RA use will be insufficient. Generative artificial intelligence (GenAI) has the potential to offset the clinical and administrative demands associated with the management of patients on these medication types. Early adoption of GenAI to facilitate the management of these GLP-1/dual RAs has the potential to improve health outcomes while decreasing its concomitant workload. Research and development efforts are urgently needed to develop GenAI obesity medication management tools, as well as to ensure their accessibility and use by encouraging their integration into health care delivery systems.
PMCID:11611792
PMID: 39622675
ISSN: 2371-4379
CID: 5804302

Prenatal chemical exposures and the methylome: current evidence and opportunities for environmental epigenetics

Bozack, Anne K; Trasande, Leonardo
Exposure to pollutants and chemicals during critical developmental periods in early life can impact health and disease risk across the life course. Research in environmental epigenetics has provided increasing evidence that prenatal exposures affect epigenetic markers, particularly DNA methylation. In this article, we discuss the role of DNA methylation in early life programming and review evidence linking the intrauterine environment to epigenetic modifications, with a focus on exposure to tobacco smoke, metals, and endocrine-disrupting chemicals. We also discuss challenges and novel approaches in environmental epigenetic research and explore the potential of epigenetic biomarkers in studies of pediatric populations as indicators of exposure and disease risk. Overall, we aim to highlight how advancements in environmental epigenetics may transform our understanding of early-life exposures and inform new approaches for supporting long-term health.
PMID: 39539208
ISSN: 1750-192x
CID: 5753362

The criticality of reasonable accommodations: A scoping review revealing gaps in care for patients with blindness and low vision

Keegan, Grace; Rizzo, John-Ross; Morris, Megan A; Joseph, Kathie-Ann
BACKGROUND:Health and healthcare disparities for surgical patients with blindness and low vision (pBLV) stem from inaccessible healthcare systems that lack universal design principles or, at a minimum, reasonable accommodations (RA). OBJECTIVES/OBJECTIVE:We aimed to identify barriers to developing and implementing RAs in the surgical setting and provide a review of best practices for providing RAs. METHODS:We conducted a search of PubMed for evidence of reasonable accommodations, or lack thereof, in the surgical setting. Articles related to gaps and barriers to providing RAs for pBLV or best practices for supporting RAs were reviewed for the study. RESULTS:Barriers to the implementation of reasonable accommodations, and, accordingly, best practices for achieving equity for pBLV, relate to policies and systems, staff knowledge and attitudes, and materials and technology. CONCLUSIONS:These inequities for pBLV require comprehensive frameworks that offer, maintain, and support education about disability disparities and RAs in the surgical field. Providing RAs for surgical pBLV, and all patients with disabilities is an important and impactful step towards creating a more equitable and anti-ableist health system.
PMID: 39550827
ISSN: 1879-1883
CID: 5757912

The Pittsburgh Study: A Tiered Model To Support Parents During Early Childhood

Krug, Chelsea Weaver; Mendelsohn, Alan L; Wuerth, Jordan; Roby, Erin; Shaw, Daniel S
OBJECTIVE:To test the feasibility of implementing The Pittsburgh Study's (TPS) Early Childhood Collaborative, a population-level, community-partnered initiative to promote relational health by offering accessible preventive parenting program options for families with young children. STUDY DESIGN/METHODS:TPS partnered with healthcare and community agencies serving families in Allegheny County, Pennsylvania, to enroll and screen 878 parents of 1,040 children 4-years-old and under. Participants were assigned to one of four tiered groups based on identified needs: (1) universal, (2) targeted/universal, (3) secondary/tertiary, or (4) tertiary programs. Parents were offered choices in empirically supported parenting programs within group ranging from texting programs to intensive home visiting. Program selection was optional. Chi-square tests were conducted to examine the likelihood of selecting a program by group. RESULTS:About 25% of participants were assigned to each tiered group; 78% of parents chose to enroll in a parenting program. In general, parents with higher levels of adversity were more likely to select a parenting program compared with those reporting less adversity, including secondary/tertiary versus targeted/universal groups (81.4% vs. 72.8%), and tertiary versus universal and targeted/universal groups (83% vs. 74.1% and 72.8%, respectively; p < .001). CONCLUSION/CONCLUSIONS:Our high program enrollment rate supports the feasibility of TPS. TPS successfully engaged families in the study by offering choices in, and optimizing accessibility to, parenting programs. TPS is highly aligned with recent recommendations by the American Academy of Pediatrics for tiered approaches as part of a broad public health strategy for supporting early relational health.
PMID: 39536860
ISSN: 1097-6833
CID: 5753232

Identifying important and feasible primary care structures and processes in the US healthcare system: a modified Delphi study

Albert, Stephanie L; Kwok, Lorraine; Shelley, Donna R; Paul, Maggie M; Blecker, Saul B; Nguyen, Ann M; Harel, Daphna; Cleland, Charles M; Weiner, Bryan J; Cohen, Deborah J; Damschroder, Laura; Berry, Carolyn A
OBJECTIVE:To identify primary care structures and processes that have the highest and lowest impact on chronic disease management and screening and prevention outcomes as well as to assess the feasibility of implementing these structures and processes into practice. DESIGN/METHODS:A two-round Delphi study was conducted to establish consensus on the impact and feasibility of 258 primary care structures and processes. PARTICIPANTS/METHODS:29 primary care providers, health system leaders and health services researchers in the USA. OUTCOMES/RESULTS:Primary outcomes were (1) consensus on the impact of each structure and process on chronic disease management and screening and prevention outcomes, separately and (2) consensus on feasibility of implementation by primary care practices. RESULTS:Consensus on high impact and feasibility of implementation was reached on four items for chronic disease management: 'Providers use motivational interviewing to help patients set goals', 'Practice has designated staff to manage patient panel', 'Practice has onsite providers or staff that speak the most dominant, non-English language spoken by patients' and 'Practice includes mental health providers and/or behavioural health specialists in care team' and seven items for screening and prevention: 'Practice utilizes standing protocols and orders', 'Practice generates reports to alert clinicians to missed targets and to identify gaps in care, such as overdue visits, needed vaccinations, screenings or other preventive services', 'Practice has designated staff to manage patient panel', 'Practice sets performance goals and uses benchmarking to track quality of care', 'Practice uses performance feedback to identify practice-specific areas of improvement', 'Practice builds quality improvement activities into practice operations' and 'Pre-visit planning data are reviewed during daily huddles'. Only 'Practice has designated staff to manage patient panel' appeared on both lists. CONCLUSION/CONCLUSIONS:Findings suggest that practices need to focus on implementing mostly distinct, rather than common, structures and processes to optimise chronic disease and preventive care.
PMCID:11552005
PMID: 39521461
ISSN: 2044-6055
CID: 5752382

Role of social-cognitive factors in the relationship between e-cigarette use and subsequent cigarette smoking among U.S. youth: A causal mediation analysis

Xu, Shu; Coffman, Donna L; Luta, George; Mai, Andi; Jiang, Nan; Niaura, Raymond S
OBJECTIVE:E-cigarette use is associated with subsequent cigarette smoking among youth. The current study examined the mediating role of social-cognitive factors in this association. METHODS:Data from four waves of the Population Assessment of Tobacco and Health study (2013/4 - 2017/8) were analyzed. Among youth who had heard about e-cigarettes at Wave 1 but never used cigarettes before Wave 2, we conducted both causal and traditional mediation analyses to examine the mediated effect of social-cognitive factors (including relative harm perception of e-cigarettes versus cigarettes, harm perception of e-cigarette use, perceptions of addictiveness of e-cigarette use, and e-cigarette use among best friends) in the association between e-cigarette use and subsequent cigarette ever or current smoking, adjusting for covariates. We included sampling weights in all analyses; hence, results are generalizable to the U.S. youth (12 - 14 years) from the 2013-2014 cohort. RESULTS:Results from causal mediation analyses indicated that the total effect of e-cigarette use, compared to no use, increased the risk of cigarette ever smoking (20.9 %) and current smoking (4.6 %). A portion of this effect (4.2 % - 15.1 % for ever smoking; less than 10.6 % for current smoking) can be attributed to changes in social-cognitive factors induced by e-cigarette use. However, these mediated effects were small in magnitude relative to their standard errors and not statistically significant. Results from the traditional mediation analyses largely aligned with these findings, except for a few small sized pathways. CONCLUSIONS:For the U.S. youth population, social-cognitive factors may only minimally or not at all mediate the association between e-cigarette use and subsequent cigarette smoking. Further investigation into the mediation role of social-cognitive factors is warranted. Tobacco control interventions that focus on cigarette smoking initiation among youth should target other mediating factors.
PMID: 39520900
ISSN: 1873-6327
CID: 5752342