Stakeholder engagement in eight comparative effectiveness trials in African Americans and Latinos with asthma.

BACKGROUND: The effects of stakeholder engagement, particularly in comparative effectiveness trials, have not been widely reported. In 2014, eight comparative effectiveness studies targeting African Americans and Hispanics/Latinos with uncontrolled asthma were funded by the Patient-Centered Outcomes Research Institute (PCORI) as part of its Addressing Disparities Program. Awardees were required to meaningfully involve patients and other stakeholders. Using specific examples, we describe how these stakeholders substantially changed the research protocols and in other ways participated meaningfully as full partners in the development and conduct of the eight studies. METHODS: Using the method content analysis of cases, we identified themes regarding the types of stakeholders, methods of engagement, input from the stakeholders, changes made to the research protocols and processes, and perceived benefits and challenges of the engagement process. We used summaries from meetings of the eight teams, results from an engagement survey, and the final research reports as our data source to obtain detailed information. The descriptive data were assessed by multiple reviewers using inductive and deductive qualitative methods and discussed in the context of engagement literature. RESULTS: Stakeholders participated in the planning, conduct, and dissemination phases of all eight asthma studies. All the studies included clinicians and community representatives as stakeholders. Other stakeholders included patients with asthma, their caregivers, advocacy organizations, and health-system representatives. Engagement was primarily by participation in advisory boards, although six of the eight studies (75%) also utilized focus groups and one-on-one interviews. Difficulty finding a time and location to meet was the most reported challenge to engagement, noted by four of the eight teams (50%). Other reported challenges and barriers to engagement included recruitment of stakeholders, varying levels of enthusiasm among stakeholders, controlling power dynamics, and ensuring that stakeholder involvement was reflected and had true influence on the project. CONCLUSION: Engagement-driven modifications led to specific changes in study design and conduct that were felt to have increased enrollment and the general level of trust and support of the targeted communities. The level of interaction described, between investigators and stakeholders in each study and between investigator-stakeholder groups, is-we believe-unprecedented and may provide useful guidance for other studies seeking to improve the effectiveness of community-driven research.

The goal of comparative clinical effectiveness research is to compare healthcare options and learn which work best for patients depending on their preferences and circumstances. Research efforts can be more effective when researchers engage stakeholders, such as patients, healthcare providers, and other members of the community­especially those communities or groups targeted by the planned research. Stakeholders can give their input throughout the research process to make sure the study will address questions and concerns that are most important and useful for participants. In 2014, the PCORI funded eight research studies that evaluated various ways to help African Americans and Hispanics/Latinos with poorly controlled asthma. These groups are underrepresented in asthma research but have higher rates of and more severe asthma for reasons that are poorly understood. The goal of this report is to show how stakeholders­including patients with asthma from these underrepresented groups, healthcare providers who care for patients with asthma, key representatives from the communities and others­participated as full partners in the eight studies and helped to improve the overall quality of the research and the relationship between the researchers and the community.

Houston hurricane Harvey health (Houston-3H) study: assessment of allergic symptoms and stress after hurricane Harvey flooding.

BACKGROUND: In August 2017, Hurricane Harvey caused unprecedented flooding across the greater Houston area. Given the potential for widespread flood-related exposures, including mold and sewage, and the emotional and mental toll caused by the flooding, we sought to evaluate the short- and long-term impact of flood-related exposures on the health of Houstonians. Our objectives were to assess the association of flood-related exposures with allergic symptoms and stress among Houston-area residents at two time points: within approximately 30 days (T1) and 12 months (T2) after Hurricane Harvey's landfall. METHODS: The Houston Hurricane Harvey Health (Houston-3H) Study enrolled a total of 347 unique participants from four sites across Harris County at two times: within approximately 1-month of Harvey (T1, n = 206) and approximately 12-months after Harvey (T2, n = 266), including 125 individuals who participated at both time points. Using a self-administered questionnaire, participants reported details on demographics, flood-related exposures, and health outcomes, including allergic symptoms and stress. RESULTS: The majority of participants reported hurricane-related flooding in their homes at T1 (79.1%) and T2 (87.2%) and experienced at least one allergic symptom after the hurricane (79.4% at T1 and 68.4% at T2). In general, flood-exposed individuals were at increased risk of upper respiratory tract allergic symptoms, reported at both the T1 and T2 time points, with exposures to dirty water and mold associated with increased risk of multiple allergic symptoms. The mean stress score of study participants at T1 was 8.0 ± 2.1 and at T2, 5.1 ± 3.2, on a 0-10 scale. Participants who experienced specific flood-related exposures reported higher stress scores when compared with their counterparts, especially 1 year after Harvey. Also, a supplementary paired-samples analysis showed that reports of wheezing, shortness of breath, and skin rash did not change between T1 and T2, though other conditions were less commonly reported at T2. CONCLUSION: These initial Houston-3H findings demonstrate that flooding experiences that occurred as a consequence of Hurricane Harvey had lasting impacts on the health of Houstonians up to 1 year after the hurricane.

Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial.

A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults-a population disproportionately affected by asthma. The primary goals were to help participants reduce allergens and irritants in their homes and better manage their disease through knowledge, improved medication use, and behavior change. HIITBAC had two groups: clinic-only and home-visit groups. Both groups received enhanced clinical care, but the home-visit group also received a detailed home assessment and four additional home visits spaced over roughly one year. We recruited 263 participants. Of these, 152 (57.8%) were recruited through electronic health record data, 51 (19.4%) through Emergency Medical Services data, and 60 (22.8%) through other efforts (e.g., emergency departments, community events, outreach). Seventy participants (26.6%) were lost to follow up, substantially more in the home-visit than in the clinic-only group. We describe the HIITBAC methodology and cohort, discuss lessons learned about recruitment and retention, and highlight adaptations we implemented to address these lessons.

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies.

BACKGROUND: African-American and Latino patients are often difficult to recruit for asthma studies. This challenge is a barrier to improving asthma care and outcomes for these populations. OBJECTIVES: We sought to examine the recruitment experiences of 8 asthma comparative effectiveness studies that specifically targeted African-American and Latino patients, and identify the solutions they developed to improve recruitment. METHODS: Case report methodology was used to gather and evaluate information on study design, recruitment procedures and outcomes from study protocols and annual reports, and in-depth interviews with each research team. Data were analyzed for themes, commonalities, and differences. RESULTS: There were 4 domains of recruitment challenges: individual participant, institutional, research team, and study intervention. Participants had competing demands for time and some did not believe they had asthma. Institutional challenges included organizational policies governing monetary incentives and staff hiring. Research team challenges included ongoing training needs of recruitment staff, and intervention designs often were unappealing to participants because of inconveniences. Teams identified a host of strategies to address these challenges, most importantly engagement of patients and other stakeholders in study design and troubleshooting, and flexibility in data collection and intervention application to meet the varied needs of patients. CONCLUSIONS: Asthma researchers may have greater success with recruitment by addressing uncertainty among patients about asthma diagnosis, engaging stakeholders in all aspects of study design and implementation, and maximizing flexibility of study and intervention protocols. However, even with such efforts, engagement of African-American and Latino patients in asthma research may remain low. Greater investment in research on engaging these populations in asthma research may ultimately be needed to improve their asthma care and outcomes.

Preterm birth and its associations with residence and ambient vehicular traffic exposure.

BACKGROUND: Preterm birth (PTB) is a multifactorial disorder, and air pollution has been suggested to increase the risk of occurrence. However, large population studies controlling for multiple exposure measures in high-density settings with established commuter patterns are lacking. OBJECTIVE: We performed a geospatial analysis with the use of a publicly available database to identify whether residence during pregnancy, specifically with regard to exposure to traffic density and mobility in urban and suburban neighborhoods, may be a contributing risk factor for premature delivery. STUDY DESIGN: In our cohort study, we analyzed 9004 pregnancies with as many as 4900 distinct clinical and demographic variables from Harris County, Texas. On the basis of primary residency and occupational zip code information, geospatial analysis was conducted. Data on vehicle miles traveled (VMT) and percentages of inhabitants traveling to work were collected at the zip code level and additionally grouped by the three recognized regional commuter loop high-density thoroughfares resulting from two interstate/highway belts (inner, middle, and outer loops). PTB was categorized as late (34 1/7 to 36 6/7 weeks) and early PTB (22 1/7 to 33 6/7 weeks), and unadjusted odds ratios (OR) and adjusted ORs were ascribed. RESULTS: PTB prevalence in our study population was 10.1% (6.8% late and 3.3% early preterm), which is in accordance with our study and other previous studies. Prevalence of early PTB varied significantly between the regional commuter loop thoroughfares [OR for inner vs outer loop: 0.58 (95% confidence interval, 0.39-0.87), OR for middle vs outer loop, 0.74 (0.57-0.96)]. The ORs for PTB and early PTB were shown to be lower in gravidae from neighborhoods with the highest VMT/acre [OR for PTB, 0.82 (0.68-0.98), OR for early PTB, 0.78 (0.62-0.98)]. Conversely, risk of PTB and early PTB among subjects living in neighborhoods with a high percentage of inhabitants traveling to work over a greater distance demonstrated a contrary tendency [OR for PTB, 1.18 (1.03-1.35), OR for early PTB, 1.48 (1.17-1.86)]. In logistic regression models, the described association between PTB and residence withstood and could not be explained by differences in maternal age, gravidity or ethnicity, tobacco use, or history of PTB. CONCLUSION: While PTB is of multifactorial origin, the present study shows that community-based risk factors (namely urban/suburban location, differences in traffic density exposure, and need for traveling to work along high-vehicle density thoroughfares) may influence risk for PTB. Further research focusing on previously unrecognized community-based risk factors may lead to innovative future prevention measures.

Geospatial analysis of food environment demonstrates associations with gestational diabetes.

BACKGROUND: Gestational diabetes mellitus (GDM) is one of most common complications of pregnancy, with incidence rates varying by maternal age, race/ethnicity, obesity, parity, and family history. Given its increasing prevalence in recent decades, covariant environmental and sociodemographic factors may be additional determinants of GDM occurrence. OBJECTIVE: We hypothesized that environmental risk factors, in particular measures of the food environment, may be a diabetes contributor. We employed geospatial modeling in a populous US county to characterize the association of the relative availability of fast food restaurants and supermarkets to GDM. STUDY DESIGN: Utilizing a perinatal database with >4900 encoded antenatal and outcome variables inclusive of ZIP code data, 8912 consecutive pregnancies were analyzed for correlations between GDM and food environment based on countywide food permit registration data. Linkage between pregnancies and food environment was achieved on the basis of validated 5-digit ZIP code data. The prevalence of supermarkets and fast food restaurants per 100,000 inhabitants for each ZIP code were gathered from publicly available food permit sources. To independently authenticate our findings with objective data, we measured hemoglobin A1c levels as a function of geospatial distribution of food environment in a matched subset (n = 80). RESULTS: Residence in neighborhoods with a high prevalence of fast food restaurants (fourth quartile) was significantly associated with an increased risk of developing GDM (relative to first quartile: adjusted odds ratio, 1.63; 95% confidence interval, 1.21-2.19). In multivariate analysis, this association held true after controlling for potential confounders (P = .002). Measurement of hemoglobin A1c levels in a matched subset were significantly increased in association with residence in a ZIP code with a higher fast food/supermarket ratio (n = 80, r = 0.251 P < .05). CONCLUSION: As demonstrated by geospatial analysis, a relationship of food environment and risk for gestational diabetes was identified.

A survey of environmental safety issues at 20 medical clinics.

In the study described in this article, the authors performed safety walk-throughs or inspections for 20 clinics located both inside a major medical center clinic (onsite) and away from the main clinic site (offsite). A checklist was used to evaluate compliance with institutional, local, state, and federal guidelines and regulations. The results obtained at onsite clinics were compared with the results from offsite clinics. Findings suggested no overall difference in the number of yes (desirable) answers. A marginally significant difference, however, was observed between the onsite and offsite clinics with regard to knowledge of infection control and waste/infection control questions. The walk-throughs helped create an improved working relationship between clinic personnel and environmental safety personnel, allowed for correction of safety issues, enabled an informal training opportunity, and increased institutional compliance with guidelines and regulations.

Memory, emotional and vocational impairments before and after anterior temporal lobectomy for complex partial seizures.

PURPOSE: To assess the pre- and postsurgical frequency of memory, emotional, and vocational impairments in patients who underwent anterior temporal lobectomy (ATL), and to assess the relationship between emotional disturbance and memory abilities after ATL. METHODS: Retrospective analysis of data was performed on 90 patients with medically intractable complex partial seizures who underwent ATL between 1981 and 2003. Patients were evaluated an average of 5 months before surgery and 11.3 months after surgery. RESULTS: A moderate to high frequency of memory impairment (44.4%; verbal or nonverbal), emotional disturbance (38.9%) and unemployment (27.8%) existed in the same individuals both before and after surgery. There were small to moderate rates of new onset memory (18.9%), emotional (11.1%), and vocational (7.8%) difficulties after surgery often regardless of seizure control outcome. Patients who underwent left-ATL and had emotional disturbance after surgery had the lowest verbal memory test scores. CONCLUSIONS: Results highlight the importance of taking into account emotional status when assessing memory abilities after ATL. Results replicate the finding of moderate to high frequencies of memory impairment, emotional disturbance, and unemployment both before and after ATL. Results provide support for the rationale that cognitive, psychiatric and vocational interventions are indicated to mitigate the problems that exist before and persist after ATL.

Environmental health: a survey of Texas primary care physicians.

Although the role of environmental health hazards in cancer and other diseases is increasingly appreciated, most physicians have had little or no training in environmental health or in integrating exposure histories into their clinical practice. As part of the Texas Medical Association Physician Oncology Education Program, we mailed a questionnaire to 350 Texas primary care physicians (PCPs) to evaluate their attitudes, practice, training, and preferred sources for information regarding environmental health issues. Of the respondents, 86.1% reported that they had never received specific training in environmental health history-taking and 91.7% indicated a desire to learn more about environmental health hazards. The data also revealed that patients regularly raise questions about environmental topics that PCPs do not routinely discuss. Our findings identify a need for more environmental health education for Texas PCPs, and we suggest several possible mechanisms by which this might be accomplished.

Basal ganglia neuronal discharge in primary and secondary dystonia in patients undergoing pallidotomy.

OBJECTIVE: Basal ganglia neuronal activity in patients undergoing posteroventral pallidotomy (PVP) for the treatment of primary genetic, secondary, or idiopathic dystonia (DYS) was studied to gain a better understanding of the pathophysiology of DYS. METHODS: Intraoperative neurophysiological data recorded from 15 DYS patients were compared with those from 78 patients with Parkinson's disease (PD) who underwent PVP. RESULTS: Putamen neurons in both DYS and PD patients had low discharge rates. Globus pallidus externa (GPe) and globus pallidus interna (GPi) neurons in DYS patients had significantly lower discharge rates and more irregular discharge patterns than in PD patients. GPe and GPi neurons displayed similar discharge rates and patterns in DYS, whereas in PD, the discharge rate of GPe neurons was lower than that of the GPi neurons. The discharge rate and pattern of GPe and GPi neurons in patients whose DYS was ameliorated by PVP were similar to those in DYS patients who did not benefit from PVP. No significant differences in the rate or pattern of neuronal discharge in patients with DYS of different causes were discernible. PVP was most beneficial in patients with primary genetic DYS. Anesthesia with desflurane depressed the discharge rate of the GPe and GPi neurons, particularly in patients with PD. CONCLUSION: Significant differences in the rates and patterns of discharge of GPe and GPi neurons exist in DYS and PD. The findings are discussed with reference to the current model of the functional connections of the basal ganglia.

Seizure control and cognitive outcome after temporal lobectomy: a comparison of classic Ammon's horn sclerosis, atypical mesial temporal sclerosis, and tumoral pathologies.

PURPOSE: Neuropathologic examination of resected tissue after anterior temporal lobectomy (ATL) for treatment of complex partial seizures revealed several distinct histologic substrates. Our study examined the relation between neuropathology, seizure control, and cognition in ATL patients and described preliminary profiles to aid in the prediction of outcome. METHODS: Of the 149 patients who underwent ATL from 1980 to 1999, long-term follow-up was available for 145. Specimens from 124 of the 145 patients had histologic findings consistent with one of three diagnoses: classic Ammon's horn sclerosis (cAHS; n = 75), atypical mesial sclerosis (Atypical; n = 21), or low-grade tumor (Tumor; n = 28). The other 20 patients had diverse pathologies that were insufficient for analysis. ATL patients underwent a complete preoperative and 68 underwent a postoperative neuropsychological evaluation. RESULTS: Of the 145 patients, 84% of cAHS, 57% of Tumor, and 29% of Atypical patients had a > or =95% reduction in seizure frequency. Neuropsychological testing suggested that cAHS patients demonstrate more generalized preoperative cognitive impairment than do the Atypical or Tumor patients. The Atypical group recalled significantly less nonverbal material after surgery than did the cAHS or Tumor groups. Stratification by both pathology and surgery side revealed that the right Atypical patients declined more on information processing and set shifting. CONCLUSIONS: Patients with cAHS or Tumor demonstrated better seizure control and fewer declines in cognitive functioning after ATL than did the Atypical patients, highlighting the need to investigate this group as a distinct entity.