Barriers and Facilitators Impacting Lung Cancer Screening Uptake Among Black Veterans: A Qualitative Study.

BACKGROUND: Racial disparities in lung cancer screening (LCS) are well established. Black Veterans are among those at the highest risk for developing lung cancer but are less likely to complete LCS. We sought to identify barriers and facilitators to LCS uptake among Black Veterans. PATIENTS AND METHODS: A qualitative study using semistructured interviews was conducted with 32 Black Veterans to assess for barriers, facilitators, and contextual factors for LCS and strategies to improve screening. Veterans were purposively sampled by age, sex, and LCS participation status (ie, patients who received a low-dose CT [LDCT], patients who contacted the screening program but did not receive an LDCT, and patients who did not connect with the screening program nor receive an LDCT). Interview guides were developed using the Theoretical Domains Framework and Health Belief Model. Data were analyzed using rapid qualitative analysis. RESULTS: Barriers of LCS uptake among Black Veterans include self-reported low LCS knowledge and poor memory, attention, and decision processes associated with the centralized LCS process. Facilitators of LCS uptake among Black Veterans include social/professional role; identity and social influences; perceived susceptibility, threat, and consequences due to smoking status and military or occupational exposures; emotion, behavioral regulation, and intentions; and high trust in providers. Environmental context and resources (eg, transportation) and race and racism serve as contextual factors that did not emerge as having a major impact on LCS uptake. Strategies to improve LCS uptake included increased social messaging surrounding LCS, various forms of information dissemination, LCS reminders, balanced and repeated shared decision-making discussions, and streamlined referrals. CONCLUSIONS: We identified addressable barriers and facilitators for LCS uptake among Black Veterans that can help focus efforts to improve disparities in screening. Future studies should explore provider perspectives and test interventions to improve equity in LCS.

Mobile Application-Based Communication Facilitation Platform for Family Members of Critically Ill Patients: A Randomized Clinical Trial.

Importance: Unmet and racially disparate palliative care needs are common in intensive care unit (ICU) settings. Objective: To test the effect of a primary palliative care intervention vs usual care control both overall and by family member race. Design, Setting, and Participants: This cluster randomized clinical trial was conducted at 6 adult medical and surgical ICUs in 2 academic and community hospitals in North Carolina between April 2019 and May 2022 with physician-level randomization and sequential clusters of 2 Black patient-family member dyads and 2 White patient-family member dyads enrolled under each physician. Eligible participants included consecutive patients receiving mechanical ventilation, their family members, and their attending ICU physicians. Data analysis was conducted from June 2022 to May 2023. Intervention: A mobile application (ICUconnect) that displayed family-reported needs over time and provided ICU attending physicians with automated timeline-driven communication advice on how to address individual needs. Main Outcomes and Measures: The primary outcome was change in the family-reported Needs at the End-of-Life Screening Tool (NEST; range 0-130, with higher scores reflecting greater need) score between study days 1 and 3. Secondary outcomes included family-reported quality of communication and symptoms of depression, anxiety, and posttraumatic stress disorder at 3 months. Results: A total of 111 (51% of those approached) family members (mean [SD] age, 51 [15] years; 96 women [86%]; 15 men [14%]; 47 Black family members [42%]; 64 White family members [58%]) and 111 patients (mean [SD] age, 55 [16] years; 66 male patients [59%]; 45 Black patients [41%]; 65 White patients [59%]; 1 American Indian or Alaska Native patient [1%]) were enrolled under 37 physicians randomized to intervention (19 physicians and 55 patient-family member dyads) or control (18 physicians and 56 patient-family member dyads). Compared with control, there was greater improvement in NEST scores among intervention recipients between baseline and both day 3 (estimated mean difference, -6.6 points; 95% CI, -11.9 to -1.3 points; P = .01) and day 7 (estimated mean difference, -5.4 points; 95% CI, -10.7 to 0.0 points; P = .05). There were no treatment group differences at 3 months in psychological distress symptoms. White family members experienced a greater reduction in NEST scores compared with Black family members at day 3 (estimated mean difference, -12.5 points; 95% CI, -18.9 to -6.1 points; P < .001 vs estimated mean difference, -0.3 points; 95% CI, -9.3 to 8.8 points; P = .96) and day 7 (estimated mean difference, -9.5 points; 95% CI, -16.1 to -3.0 points; P = .005 vs estimated mean difference, -1.4 points; 95% CI, -10.7 to 7.8; P = .76). Conclusions and Relevance: In this study of ICU patients and family members, a primary palliative care intervention using a mobile application reduced unmet palliative care needs compared with usual care without an effect on psychological distress symptoms at 3 months; there was a greater intervention effect among White family members compared with Black family members. These findings suggest that a mobile application-based intervention is a promising primary palliative care intervention for ICU clinicians that directly addresses the limited supply of palliative care specialists. Trial Registration: ClinicalTrials.gov Identifier: NCT03506438.

Racial Disparities in Lung Cancer Screening Among Veterans, 2013 to 2021.

Importance: Racial disparities in lung cancer screening (LCS) are often ascribed to barriers such as cost, insurance status, access to care, and transportation. Because these barriers are minimized within the Veterans Affairs system, there is a question of whether similar racial disparities exist within a Veterans Affairs health care system in North Carolina. Objectives: To examine whether racial disparities in completing LCS after referral exist at the Durham Veterans Affairs Health Care System (DVAHCS) and, if so, what factors are associated with screening completion. Design, Setting, and Participants: This cross-sectional study assessed veterans referred to LCS between July 1, 2013, and August 31, 2021, at the DVAHCS. All included veterans self-identified as White or Black and met the US Preventive Services Task Force eligibility criteria as of January 1, 2021. Participants who died within 15 months of consultation or who were screened before consultation were excluded. Exposures: Self-reported race. Main Outcomes and Measures: Screening completion was defined as completing computed tomography for LCS. The associations among screening completion, race, and demographic and socioeconomic risk factors were assessed using logistic regression models. Results: A total of 4562 veterans (mean [SD] age, 65.4 [5.7] years; 4296 [94.2%] male; 1766 [38.7%] Black and 2796 [61.3%] White) were referred for LCS. Of all veterans referred, 1692 (37.1%) ultimately completed screening; 2707 (59.3%) never connected with the LCS program after referral and an informational mailer or telephone call, indicating a critical point in the LCS process. Screening rates were substantially lower among Black compared with White veterans (538 [30.5%] vs 1154 [41.3%]), with Black veterans having 0.66 times lower odds (95% CI, 0.54-0.80) of screening completion after adjusting for demographic and socioeconomic factors. Conclusions and Relevance: This cross-sectional study found that after referral for initial LCS via a centralized program, Black veterans had 34% lower odds of LCS screening completion compared with White veterans, a disparity that persisted even after accounting for numerous demographic and socioeconomic factors. A critical point in the screening process was when veterans must connect with the screening program after referral. These findings may be used to design, implement, and evaluate interventions to improve LCS rates among Black veterans.

Trajectories of Palliative Care Needs in the ICU and Long-Term Psychological Distress Symptoms.

OBJECTIVES: While palliative care needs are assumed to improve during ICU care, few empiric data exist on need trajectories or their impact on long-term outcomes. We aimed to describe trajectories of palliative care needs during ICU care and to determine if changes in needs over 1 week was associated with similar changes in psychological distress symptoms at 3 months. DESIGN: Prospective cohort study. SETTING: Six adult medical and surgical ICUs. PARTICIPANTS: Patients receiving mechanical ventilation for greater than or equal to 2 days and their family members. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the 13-item Needs at the End-of-Life Screening Tool (NEST; total score range 0-130) completed by family members at baseline, 3, and 7 days. The Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Post-Traumatic Stress Scale (PTSS) were completed at baseline and 3 months. General linear models were used to estimate differences in distress symptoms by change in need (NEST improvement ≥ 10 points or not). One-hundred fifty-nine family members participated (median age, 54.0 yr [interquartile range (IQR), 44.0-63.0 yr], 125 [78.6%] female, 54 [34.0%] African American). At 7 days, 53 (33%) a serious level of overall need and 35 (22%) ranked greater than or equal to 1 individual need at the highest severity level. NEST scores improved greater than or equal to 10 points in only 47 (30%). Median NEST scores were 22 (IQR, 12-40) at baseline and 19 (IQR, 9-37) at 7 days (change, -2.0; IQR, -11.0 to 5.0; p = 0.12). There were no differences in PHQ-9, GAD-7, or PTSS change scores by change in NEST score (all p > 0.15). CONCLUSIONS: Serious palliative care needs were common and persistent among families during ICU care. Improvement in needs was not associated with less psychological distress at 3 months. Serious needs may be commonly underrecognized in current practice.

Palliative care phenotypes among critically ill patients and family members: intensive care unit prospective cohort study.

OBJECTIVE: Because the heterogeneity of patients in intensive care units (ICUs) and family members represents a challenge to palliative care delivery, we aimed to determine if distinct phenotypes of palliative care needs exist. METHODS: Prospective cohort study conducted among family members of adult patients undergoing mechanical ventilation in six medical and surgical ICUs. The primary outcome was palliative care need measured by the Needs at the End-of-Life Screening Tool (NEST, range from 0 (no need) to 130 (highest need)) completed 3 days after ICU admission. We also assessed quality of communication, clinician-family relationship and patient centredness of care. Latent class analysis of the NEST's 13 items was used to identify groups with similar patterns of serious palliative care needs. RESULTS: Among 257 family members, latent class analysis yielded a four-class model including complex communication needs (n=26, 10%; median NEST score 68.0), family spiritual and cultural needs (n=21, 8%; 40.0) and patient and family stress needs (n=43, 31%; 31.0), as well as a fourth group with fewer serious needs (n=167, 65%; 14.0). Interclass differences existed in quality of communication (median range 4.0-10.0, p<0.001), favourable clinician-family relationship (range 34.6%-98.2%, p<0.001) and both the patient centredness of care Eliciting Concerns (median range 4.0-5.0, p<0.001) and Decision-Making (median range 2.3-4.5, p<0.001) scales. CONCLUSIONS: Four novel phenotypes of palliative care need were identified among ICU family members with distinct differences in the severity of needs and perceived quality of the clinician-family interaction. Knowledge of need class may help to inform the development of more person-centred models of ICU-based palliative care.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

Assessment of Clinical Palliative Care Trigger Status vs Actual Needs Among Critically Ill Patients and Their Family Members.

Importance: Palliative care consultations in intensive care units (ICUs) are increasingly prompted by clinical characteristics associated with mortality or resource utilization. However, it is not known whether these triggers reflect actual palliative care needs. Objective: To compare unmet needs by clinical palliative care trigger status (present vs absent). Design, Setting, and Participants: This prospective cohort study was conducted in 6 adult medical and surgical ICUs in academic and community hospitals in North Carolina between January 2019 and September 2020. Participants were consecutive patients receiving mechanical ventilation and their family members. Exposure: Presence of any of 9 common clinical palliative care triggers. Main Outcomes and Measures: The primary outcome was the Needs at the End-of-Life Screening Tool (NEST) score (range, 0-130, with higher scores reflecting greater need), which was completed after 3 days of ICU care. Trigger status performance in identifying serious need (NEST score ≥30) was assessed using sensitivity, specificity, positive and negative likelihood ratios, and C statistics. Results: Surveys were completed by 257 of 360 family members of patients (71.4% of the potentially eligible patient-family member dyads approached) with a median age of 54.0 years (IQR, 44-62 years); 197 family members (76.7%) were female, and 83 (32.3%) were Black. The median age of patients was 58.0 years (IQR, 46-68 years); 126 patients (49.0%) were female, and 88 (33.5%) were Black. There was no difference in median NEST score between participants with a trigger present (45%) and those with a trigger absent (55%) (21.0; IQR, 12.0-37.0 vs 22.5; IQR, 12.0-39.0; P = .52). Trigger presence was associated with poor sensitivity (45%; 95% CI, 34%-55%), specificity (55%; 95% CI, 48%-63%), positive likelihood ratio (1.0; 95% CI, 0.7-1.3), negative likelihood ratio (1.0; 95% CI, 0.8-1.2), and C statistic (0.50; 95% CI, 0.44-0.57). Conclusions and Relevance: In this cohort study, clinical palliative care trigger status was not associated with palliative care needs and no better than chance at identifying the most serious needs, which raises questions about an increasingly common clinical practice. Focusing care delivery on directly measured needs may represent a more person-centered alternative.

Improving racial disparities in unmet palliative care needs among intensive care unit family members with a needs-targeted app intervention: The ICUconnect randomized clinical trial.

INTRODUCTION: The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced. However, the quality of ICU-based communication has remained suboptimal, particularly concerning for Black patients and their family members. Therefore we developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care. OBJECTIVE: To describe the methods and early experiences of a clustered randomized clinical trial (RCT) being conducted to compare ICUconnect vs. usual care. METHODS AND ANALYSIS: The goal of this two-arm, parallel group clustered RCT is to determine the clinical impact of the ICUconnect intervention in improving outcomes overall and for each racial subgroup on reducing racial disparities in core palliative care outcomes over a 3-month follow up period. ICU attending physicians are randomized to either ICUconnect or usual care, with outcomes obtained from family members of ICU patients. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 3 days post-randomization. Secondary outcomes include goal concordance of care and interpersonal processes of care at 3 days post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use hierarchical linear models to compare outcomes between the ICUconnect and usual care arms within all participants and assess for differential intervention effects in Blacks and Whites by adding a patient-race interaction term. We hypothesize that both compared to usual care as well as among Blacks compared to Whites, ICUconnect will reduce unmet palliative care needs, psychological distress and healthcare resource utilization while improving goal concordance and interpersonal processes of care. In this manuscript, we also describe steps taken to adapt the ICUconnect intervention to the COVID-19 pandemic healthcare setting. ENROLLMENT STATUS: A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date. Enrollment will continue until the end of 2021.

A Scoping Review of International Barriers to Asthma Medication Adherence Mapped to the Theoretical Domains Framework.

BACKGROUND: Internationally, adult asthma medication adherence rates are low. Studies characterizing variations in barriers by country are lacking. OBJECTIVE: To conduct a scoping review to characterize international variations in barriers to asthma medication adherence among adults. METHODS: MEDLINE, EMBASE, Web of Science (WOS), and CINAHL were searched from inception to February 2017. English-language studies employing qualitative methods (eg, focus groups, interviews) were selected to assess adult patient- and/or caregiver-reported barriers to asthma medication adherence. Two investigators independently identified, extracted data, and collected study characteristics, methodologic approach, and barriers. Barriers were mapped using the Theoretical Domains Framework and findings categorized according to participants' country of residence, countries' gross national income, and the presence of universal health care (World Health Organization definitions). RESULTS: Among 2942 unique abstracts, we reviewed 809 full texts. Among these, we identified 47 studies, conducted in 12 countries, meeting eligibility. Studies included a total of 2614 subjects, predominately female (67%), with the mean age of 19.1 to 70 years. Most commonly reported barriers were beliefs about consequences (eg, medications not needed for asthma control, N = 29, 61.7%) and knowledge (eg, not knowing when to take medication, N = 27, 57.4%); least common was goals (eg, asthma not a priority, N = 1, 2.1%). In 27 studies conducted in countries classified as high income (HIC) with universal health care (UHC), the most reported barrier was participants' beliefs about consequences (N = 17, 63.3%). However, environmental context and resources (N = 12, 66.7%) were more common in HIC without UHC. CONCLUSION: International adherence barriers are diverse and may vary with a country's sociopolitical context. Future adherence interventions should account for trends.

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

BACKGROUND: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review.

BACKGROUND: Cluster-randomized trials (CRTs) are being increasingly used to test a range of interventions, including medical interventions commonly used in clinical practice. Policies created by the NIH and the Food and Drug Administration (FDA) require the reporting of demographics and the examination of demographic heterogeneity of treatment effect (HTE) for individually randomized trials. Little is known about how frequent demographics are reported and HTE analyses are conducted in CRTs. OBJECTIVES: We sought to understand the prevalence of HTE analyses and the statistical methods used to conduct them in CRTs focused on treating cardiovascular disease, cancer, and chronic lower respiratory diseases. Additionally, we also report on the proportion of CRTs that reported on baseline demographics of its populations and conducted demographic HTE analyses. DATA SOURCES: We searched PubMed and Embase for CRTs published between 1/1/2010 and 3/29/2016 that focused on treating the top 3 Center for Disease Control causes of death (cardiovascular disease, chronic lower respiratory disease, and cancer). Evidence Screening And Review: Of 1,682 unique titles, 117 abstracts were screened. After excluding 53 articles, we included 64 CRT publications and abstracted information on study characteristics and demographic information, statistical analysis, HTE analysis, and study quality. RESULTS: Age and sex were reported in greater than 95.3% of CRTs, while race and ethnicity were reported in only 20.3% of CRTs. HTE analyses were conducted in 28.1% (n = 18) of included CRTs and 77.8% (n = 12) were prespecified analyses. Four CRTs conducted a demographic subgroup analysis. Only 6/18 CRTs used interaction testing to determine whether HTE existed. CONCLUSIONS: Baseline demographic reporting was high for age and sex in CRTs, but was uncommon for race and ethnicity. HTE analyses were uncommon and was rare for demographic subgroups, which limits the ability to examine the extent of benefits or risks for treatments tested with CRT designs.

A Systematic Review of Patient- and Family-Level Inhaled Corticosteroid Adherence Interventions in Black/African Americans.

BACKGROUND: Inhaled corticosteroid (ICS) adherence rates are suboptimal among adult black/African Americans. Comprehensive studies characterizing the effectiveness and the methodological approaches to the development of interventions to improve ICS adherence in adult black/African Americans have not been performed. OBJECTIVES: Conduct a systematic review of patient/family-level interventions to improve ICS adherence in adult black/African Americans. METHODS: We searched MEDLINE, EMBASE, Web of Science, and CINAHL from inception to August 2017 for English-language US studies enrolling at least 30% black/African Americans comparing patient/family-level ICS adherence interventions with any comparator. Two investigators independently selected, extracted data from, and rated risk of bias. We collected information on intervention characteristics and outcomes, and assessed whether studies were informed by behavior theory, stakeholder engagement, or both. RESULTS: Among 1661 abstracts identified, we reviewed 230 full-text articles and identified 4 randomized controlled trials (RCTs) and 1 quasi-experimental (pre-post design) study meeting criteria. Study participants (N range, 17-333) varied in mean age (22-47 years), proportion black/African Americans studied (71%-93%), and sex (69%-82% females). RCTs evaluated problem-solving classes, self-efficacy training, technology-based motivational interviewing program, and the use of patient advocates. The RCT testing self-efficacy training was the only intervention informed by both behavior theory and stakeholder engagement. All 4 RCTs compared interventions with active control and rated as medium risk of bias. No RCTs found a statistically significant improvement in adherence. CONCLUSIONS: Few studies assessing asthma adherence interventions focused on adult black/African-American populations. No RCTs demonstrated improved ICS adherence in participants. Future studies that are informed by behavior change theory and stakeholder engagement are needed.

Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

Assessing electronic health record phenotypes against gold-standard diagnostic criteria for diabetes mellitus.

OBJECTIVE: We assessed the sensitivity and specificity of 8 electronic health record (EHR)-based phenotypes for diabetes mellitus against gold-standard American Diabetes Association (ADA) diagnostic criteria via chart review by clinical experts. MATERIALS AND METHODS: We identified EHR-based diabetes phenotype definitions that were developed for various purposes by a variety of users, including academic medical centers, Medicare, the New York City Health Department, and pharmacy benefit managers. We applied these definitions to a sample of 173 503 patients with records in the Duke Health System Enterprise Data Warehouse and at least 1 visit over a 5-year period (2007-2011). Of these patients, 22 679 (13%) met the criteria of 1 or more of the selected diabetes phenotype definitions. A statistically balanced sample of these patients was selected for chart review by clinical experts to determine the presence or absence of type 2 diabetes in the sample. RESULTS: The sensitivity (62-94%) and specificity (95-99%) of EHR-based type 2 diabetes phenotypes (compared with the gold standard ADA criteria via chart review) varied depending on the component criteria and timing of observations and measurements. DISCUSSION AND CONCLUSIONS: Researchers using EHR-based phenotype definitions should clearly specify the characteristics that comprise the definition, variations of ADA criteria, and how different phenotype definitions and components impact the patient populations retrieved and the intended application. Careful attention to phenotype definitions is critical if the promise of leveraging EHR data to improve individual and population health is to be fulfilled.

Defining and targeting health disparities in chronic obstructive pulmonary disease.

The global burden of chronic obstructive pulmonary disease (COPD) continues to grow in part due to better outcomes in other major diseases and in part because a substantial portion of the worldwide population continues to be exposed to inhalant toxins. However, a disproportionate burden of COPD occurs in people of low socioeconomic status (SES) due to differences in health behaviors, sociopolitical factors, and social and structural environmental exposures. Tobacco use, occupations with exposure to inhalant toxins, and indoor biomass fuel (BF) exposure are more common in low SES populations. Not only does SES affect the risk of developing COPD and etiologies, it is also associated with worsened COPD health outcomes. Effective interventions in these people are needed to decrease these disparities. Efforts that may help lessen these health inequities in low SES include 1) better surveillance targeting diagnosed and undiagnosed COPD in disadvantaged people, 2) educating the public and those involved in health care provision about the disease, 3) improving access to cost-effective and affordable health care, and 4) markedly increasing the efforts to prevent disease through smoking cessation, minimizing use and exposure to BF, and decreasing occupational exposures. COPD is considered to be one the most preventable major causes of death from a chronic disease in the world; therefore, effective interventions could have a major impact on reducing the global burden of the disease, especially in socioeconomically disadvantaged populations.