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"Walker, Daniel M."
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Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions—A report from the “Health Equity through Diversity” seminar series
by
Nolan, Timiya S.
,
Wilson, Gerren
,
Grever, Jeff
in
Access
,
African Americans
,
Biology and Life Sciences
2023
In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts.
Two webinars in a four-part series, titled \"Health Equity through Diversity,\" were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room's conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes.
The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential.
Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.
Journal Article
Addressing non-medical health-related social needs through a community-based lifestyle intervention during the COVID-19 pandemic: The Black Impact program
2023
Non-medical health-related social needs (social needs) are major contributors to worse health outcomes and may have an adverse impact on cardiovascular risk factors and cardiovascular disease. The present study evaluated the effect of a closed-loop community-based pathway in reducing social needs among Black men in a lifestyle change program.
Black men (n = 70) from a large Midwestern city participated in Black Impact, a 24-week community-based team lifestyle change single-arm pilot trial adapted from the Diabetes Prevention Program and American Heart Association's (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's Life's Simple 7 (LS7) framework. Participants were screened using the Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities Health-Related Social Needs Screening Tool. Participants with affirmative responses were referred to a community hub pathway to address social needs. The primary outcome for this analysis is change in social needs based on the CMS social needs survey at 12 and 24 weeks using mixed effect logistic regressions with random intercepts for each participant. Change in a LS7 score (range 0-14) from baseline to 12 and 24 weeks was evaluated using a linear mixed-effects model stratified by baseline social needs.
Among 70 participants, the mean age of participants was 52 ±10.5 years. The men were sociodemographically diverse, with annual income ranging from <$20,000 (6%) to ≥$75,000 (23%). Forty-three percent had a college degree or higher level of education, 73% had private insurance, and 84% were employed. At baseline 57% of participants had at least one social need. Over 12 and 24 weeks, this was reduced to 37% (OR 0.33, 95%CI: 0.13, 0.85) and 44% (OR 0.50, 95%CI: 0.21, 1.16), respectively. There was no association of baseline social needs status with baseline LS7 score, and LS7 score improved over 12 and 24 weeks among men with and without social needs, with no evidence of a differential effect.
The Black Impact lifestyle change single-arm pilot program showed that a referral to a closed-loop community-based hub reduced social needs in Black men. We found no association of social needs with baseline or change in LS7 scores. Further evaluation of community-based strategies to advance the attainment of LS7 and address social needs among Black men in larger trials is warranted.
Journal Article
Human Seroprevalence for Dengue, Ross River, and Barmah Forest viruses in Australia and the Pacific: A systematic review spanning seven decades
2022
Dengue (DENV), Ross River (RRV) and Barmah Forest viruses (BFV) are the most common human arboviral infections in Australia and the Pacific Island Countries and Territories (PICTs) and are associated with debilitating symptoms. All are nationally notifiable in Australia, but routine surveillance is limited to a few locations in the PICTs. Understanding the level of human exposure to these viruses can inform disease management and mitigation strategies. To assess the historic and current seroprevalence of DENV, RRV and BFV in Australia and the PICTs we conducted a systematic literature review of all published quantitative serosurveys.
The Preferred Reporting of Items for Systematic Reviews and Meta-Analyses procedures were adopted to produce a protocol to systematically search for published studies reporting the seroprevalence of DENV, RRV and BFV in Australia and the PICTs. Data for author, research year, location, study population, serosurvey methods and positive tests were extracted. A total of 41 papers, reporting 78 serosurveys of DENV, RRV and BFV including 62,327 samples met the inclusion criteria for this review. Seroprevalence varied depending on the assay used, strategy of sample collection and location of the study population. Significant differences were observed in reported seropositivity depending on the sample collection strategy with clinically targeted sampling reporting the highest seroprevalence across all three viruses. Non-stratified seroprevalence showed wide ranges in reported positivity with DENV 0.0% - 95.6%, RRV 0.0% - 100.0%, and BFV 0.3% - 12.5%. We discuss some of the causes of variation including serological methods used, selection bias in sample collection including clinical or environmental associations, and location of study site. We consider the extent to which serosurveys reflect the epidemiology of the viruses and provide broad recommendations regarding the conduct and reporting of arbovirus serosurveys.
Human serosurveys provide important information on the extent of human exposure to arboviruses across: (1) time, (2) place, and (3) person (e.g., age, gender, clinical presentation etc). Interpreting results obtained at these scales has the potential to inform us about transmission cycles, improve diagnostic surveillance, and mitigate future outbreaks. Future research should streamline methods and reduce bias to allow a better understanding of the burden of these diseases and the factors associated with seroprevalence. Greater consideration should be given to the interpretation of seroprevalence in studies, and increased rigour applied in linking seroprevalence to transmission dynamics.
Journal Article
Development of a conceptual model of the capacity for patients to engage in their health care: a group concept mapping study
by
Walker, Daniel M.
,
Sieck, Cynthia J.
,
Hefner, Jennifer L.
in
Advisors
,
Concept mapping
,
Evaluation
2023
Background
Patient engagement is seen as a necessary component in achieving the triple aim of improved population health, improved experience of care, and lower per capita health care costs. While there has been a substantial increase in the number of tools and patient-centered initiatives designed to help patients participate in health decisions, there remains a limited understanding of engagement from the perspective of patients and a lack of measures designed to capture the multi-faceted nature of the concept.
Methods
Development of a concept map of patient engagement followed a five-step modified Group Concept Mapping (GCM) methodology of preparation, generation, structuring, analysis and interpretation. We engaged a Project Advisory Committee at each step, along with three rounds of survey collection from clinicians and patients for element generation (272 clinicians, 61 patients), statement sorting (30 clinicians, 15 patients), and ranking and rating of statements (159 clinicians, 67 patients). The survey of three separate samples, as opposed to focus groups of ‘experts,’ was an intentional decision to gain a broad perspective about the concept of patient engagement. We conducted the structure and analysis steps within the groupwisdom concept mapping software.
Results
The final concept map comprised 47 elements organized into 5 clusters: Relationship with Provider, Patient Attitudes and Behaviors, Access, Internal Resources and External Resources. There was considerable agreement in the way elements in each cluster were rated by patients and clinicians. An analysis of the importance of the constitutive elements of patient engagement relative to their addressability highlighted actionable items in the domain of Relationship with Provider, aimed at building trust and enabling patients to ask questions. At the same time, the analysis also identified elements traditionally considered barriers to engagement, like personal access to the internet and the patient’s level of digital literacy, as difficult to address by the healthcare system, but also relatively less important for patients.
Conclusions
Through our GCM approach, incorporating perspectives of both patients and clinicians, we identified items that can be used to assess patient engagement efforts by healthcare systems. As a result, our study offers specific insight into areas that can be targeted for intervention by healthcare systems to improve patient engagement.
Journal Article
Perspectives on Challenges and Opportunities for Interoperability: Findings From Key Informant Interviews With Stakeholders in Ohio
by
Ford, Eric W
,
Walker, Daniel M
,
Ranbom, Lorin
in
Data collection
,
Data exchange
,
Decision making
2023
Interoperability-the exchange and integration of data across the health care system-remains a challenge despite ongoing policy efforts aimed at promoting interoperability.
This study aimed to identify current challenges and opportunities to advancing interoperability across stakeholders.
Primary data were collected through qualitative, semistructured interviews with stakeholders (n=24) in Ohio from July to October 2021. Interviewees were sampled using a stratified purposive sample of key informants from 4 representative groups as follows: acute care and children's hospital leaders, primary care providers, behavioral health providers, and regional health information exchange networks. Interviews focused on key informant perspectives on electronic health record implementation, the alignment of public policy with organizational strategy, interoperability implementation challenges, and opportunities for health information technology. The interviews were transcribed verbatim followed by rigorous qualitative analysis using directed content analysis.
The findings illuminate themes related to challenges and opportunities for interoperability that align with technological (ie, implementation challenges, mismatches in interoperability capabilities across stakeholders, and opportunities to leverage new technology and integrate social determinants of health data), organizational (ie, facilitators of interoperability and strategic alignment of participation in value-based payment programs with interoperability), and environmental (ie, policy) domains.
Interoperability, although technically feasible for most providers, remains challenging for technological, organizational, and environmental reasons. Our findings suggest that the incorporation of end user considerations into health information technology development, implementation, policy, and standard deployment may support interoperability advancement.
Journal Article
Development and psychometric evaluation of a new self-report measure to assess patient engagement behaviours and capacity in the USA: the Patient Engagement Capacity Survey
2025
ObjectivePatient engagement (PE), or a patient’s participation in their healthcare, is an important component of comprehensive healthcare delivery, yet there is not an existing, publicly available, measurement tool to assess PE capacity and behaviours. We sought to develop a survey to measure PE capacity and behaviours for use in ambulatory healthcare clinics.DesignMeasure development and psychometric evaluation.Setting and participantsA total of 1180 adults in the USA from 2022 to 2024, including 1050 individuals who had indicated they had seen a healthcare provider in the prior 12 months who were recruited nationally via social media across three separate samples; 8 patient advisors and healthcare providers recruited from a large, midwestern US Academic Medical Center; and 122 patients recruited from five participating ambulatory clinics in the Midwestern USA.MethodsAn initial survey was developed based on a concept mapping approach with a Project Advisory Board composed of patients, researchers and clinicians. Social media was then used to recruit 540 participants nationally (Sample 1) to complete the initial, 101-item version of the survey to generate data for factor analysis. We conducted exploratory and confirmatory factor analyses to assess model and item fit to inform item reduction, and subsequently conducted cognitive interviews with eight additional participants (patient advisors and providers; Sample 2), who read survey items aloud, shared their thoughts and selected a response. The survey was revised and shortened based on these results. Next, a test–retest survey, also administered nationally via another round of social media recruitment, was administered two times to a separate sample (n=155; Sample 3), 2 weeks apart. We further revised the survey to remove items with low temporal stability based on these results. For clinic administration, research staff approached patients (n=122; Sample 4) in waiting rooms in one of five ambulatory clinics to complete the survey electronically or on paper to determine feasibility of in-clinic survey completion. We engaged in further item reduction based on provider feedback about survey length and fielded a final revised and shortened survey nationally via a final round of social media recruitment (n=355; Sample 5) to obtain psychometric data on this final version.Primary and secondary outcome measuresCronbach’s alphas, intraclass correlations (ICCs), Comparative Fit Index (CFI), root mean square error of approximation (RMSEA), standardised root mean squared residual (SRMR).ResultsThe final PE Capacity Survey (PECS) includes six domains across two scales: ‘engagement behaviours’ (ie, preparing for appointments, ensuring understanding, adhering to care) and ‘engagement capacity’ (ie, healthcare navigation resources, resilience, relationship with provider). The PECS is 18 questions, can be completed during a clinic visit in less than 10 minutes, and produces scores which demonstrate acceptable internal consistency reliability (α=0.72 engagement behaviours, 0.76 engagement capacity), indicating items are measuring the same overarching construct. The scales also had high test–retest reliability (ICC=0.82 behaviours, 0.86 capacity), indicating stability of response over time, and expected dimensionality with high fit indices for the final scales (behaviours: CFI=0.97; RMSEA=0.07; SRMR=0.05; capacity: CFI=0.99; RMSEA=0.06; SRMR=0.06), indicating initial evidence of construct validity.ConclusionsThe PECS is the first known measure to assess patients’ capacity for engagement and represents a step toward informing interventions and care plans that acknowledge a patient’s engagement capacity and supporting engagement behaviours. Future work should be done to validate the measure in other languages and patient populations, and to assess criterion-related validity of the measure against patient outcomes.
Journal Article
Does participation in health information exchange improve hospital efficiency?
2018
The federal government allocated nearly $30 billion to spur the development of information technology infrastructure capable of supporting the exchange of interoperable clinical data, leading to growth in hospital participation in health information exchange (HIE) networks. HIEs have the potential to improve care coordination across healthcare providers, leading ultimately to increased productivity of health services for hospitals. However, the impact of HIE participation on hospital efficiency remains unclear. This dynamic prompts the question asked by this study: does HIE participation improve hospital efficiency. This study estimates the effect of HIE participation on efficiency using a national sample of 1017 hospitals from 2009 to 2012. Using a two-stage analytic design, efficiency indices were determined using the Malmquist algorithm and then regressed on a set of hospital characteristics. Results suggest that any participation in HIE can improve both technical efficiency change and total factor productivity (TFP). A second model examining total years of HIE participation shows a benefit of one and three years of participation on TFP. These results suggest that hospital investment in HIE participation may be a useful strategy to improve hospital operational performance, and that policy should continue to support increased participation and use of HIE. More research is needed to identify the exact mechanisms through which HIE participation can improve hospital efficiency.
Journal Article
Embedding Big Qual and Team Science Into Qualitative Research: Lessons From a Large-Scale, Cross-Site Research Study
by
Dasgupta, Anindita
,
Scalise, Ariel
,
Crable, Erika L.
in
Clinical trials
,
Data analysis
,
Data collection
2023
Background: A major part of the HEALing Communities Study (HCS), launched in 2019 to address the growing opioid epidemic, is evaluating the study’s intervention implementation process through an implementation science (IS) approach. One component of the IS approach involves teams with more than 20 researchers collaborating across four research sites to conduct in-depth qualitative interviews with over 300 participants at four time points. After completion of the first two rounds of data collection, we reflect upon our qualitative data collection and analysis approach. We aim to share our lessons learned about designing and applying qualitative methods within an implementation science framework. Methods: The HCS evaluation is based on the RE-AIM/PRISM framework and incorporates interviews at four timepoints. At each timepoint, the core qualitative team of the Intervention Work Group drafts an interview guide based on the framework and insights from previous round(s) of data collection. Researchers then conduct interviews with key informants and coalition members within their respective states. Data analysis involves drafting, iteratively refining, and finalizing a codebook in a cross-site and within-site consensus processes. Interview transcripts are then individually coded by researchers within their respective states. Results: Successes in the evaluation process include having structured procedures for communication, data collection, and analysis, all of which are critical for ensuring consistent data collection and for achieving consensus during data analysis. Challenges include recognizing and accommodating the diversity of training and knowledge among researchers, as well as establishing reliable ways to securely store, manage, and share the large volumes of data. Conclusion: Qualitative methods using a Team Science approach have been limited in their application in large, multi-site randomized controlled trials of health interventions. Our experience provides practical guidance for future studies with large teams that are experientially and disciplinarily diverse and that are seeking to incorporate qualitative or mixed-methods components for their evaluations.
Journal Article
Community coalitions’ navigation of policies to address the opioid epidemic: insights from qualitative interviews in four states
by
Cogan, Allyson G
,
Olvera, Ramona G
,
Kinnard, Elizabeth N
in
Drug overdose
,
Drug use
,
Epidemics
2025
IntroductionThe opioid epidemic in the USA presents a multifaceted challenge regulated by a patchwork of federal, state and local policies. In some communities, cross-sector coalitions navigate this complex policy environment to address the epidemic. However, limited research has explored these public health-oriented community coalitions and their interactions with the policy landscape. This study explores how cross-sector public health-oriented community coalition members perceive and navigate the multidimensional policy landscapes to address the opioid epidemic.MethodsUsing data from 304 semistructured HEALing Communities Study coalition member interviews conducted April–June 2021 in 67 communities in Kentucky, New York, Massachusetts and Ohio, we inductively analysed participants’ discussions of opioid-related policies to characterise themes and subthemes.ResultsWe describe two themes where coalitions and policy intersect: policy landscape barriers and navigation and mitigation strategies to address policy barriers. Participants revealed community misunderstandings and lack of knowledge of opioid-related policies. Furthermore, participants shared how these policies often hindered coalitions’ initiatives to address substance use. Nevertheless, community coalitions functioned despite these policy challenges through knowledge sharing, innovation and policy advocacy.ConclusionsCross-sector public health-oriented community coalitions serve a vital role in navigating the complexities of the multidimensional policy landscape regulating substance use services. Insights from these findings may encourage policy-makers to support community coalitions in pursuing solutions to the opioid crisis and other public health crises.Trial registration numberNCT04111939.
Journal Article