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Objectives: Our objectives were to: 1) describe patient-reported communication with their provider and explore differences in perceptions of racially diverse adherent versus nonadherent patients; and 2) examine whether the association between unanswered questions and patientreported medication nonadherence varied as a function of patients' race. Methods: We conducted a cross-sectional analysis of baseline in-person survey data from a trial designed to improve postmyocardial infarction management of cardiovascular disease risk factors. Results: Overall, 298 patients (74%) reported never leaving their doctor's office with unanswered questions. Among those who were adherent and nonadherent with their medications, 183 (79%) and 115 (67%) patients, respectively, never left their doctor's office with unanswered questions. In multivariable logistic regression, although the simple effects of the interaction term were different for patients of nonminority race (odds ratio [OR]: 2.16; 95% confidence interval [CI]: 1.19-3.92) and those of minority race (OR: 1.19; 95% CI: 0.54-2.66), the overall interaction effect was not statistically significant (P=0.24). Conclusion: The quality of patient-provider communication is critical for cardiovascular disease medication adherence. In this study, however, having unanswered questions did not impact medication adherence differently as a function of patients' race. Nevertheless, there were racial differences in medication adherence that may need to be addressed to ensure optimal adherence and health outcomes. Effort should be made to provide training opportunities for both patients and their providers to ensure strong communication skills and to address potential differences in medication adherence in patients of diverse backgrounds. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to determine how patient preferences guide the course of palliative chemotherapy for advanced colorectal cancer.Methods: Eligible patients with metastatic colorectal cancer (mCRC) were enrolled nationwide in a prospective, population-based cohort study. Data were obtained through medical record abstraction and patient surveys. Logistic regression analysis was used to evaluate patient characteristics associated with visiting medical oncology and receiving chemotherapy and patient characteristics, beliefs, and preferences associated with receiving >1 line of chemotherapy and receiving combination chemotherapy.Results: Among 702 patients with mCRC, 91% consulted a medical oncologist; and among those, 82% received chemotherapy. Patients ages 65 to 75 years and aged ≥75 years were less likely to visit an oncologist, as were patients who were too sick to complete their own survey. In adjusted analyses, patients aged ≥75 years who had moderate or severe comorbidity were less likely to receive chemotherapy, as were patients who were too sick to complete their own survey. Patients received chemotherapy even if they believed that chemotherapy would not extend their life (90%) or that chemotherapy would not likely help with cancer-related problems (89%), or patients preferred treatment focusing on comfort even if it meant not living as long (90%). Older patients were less likely to receive combination first-line therapy. Patient preferences and beliefs were not associated with receipt of >1 line of chemotherapy or combination chemotherapy.Conclusions: The majority of patients received chemotherapy even if they expressed negative or marginal preferences or beliefs regarding chemotherapy. Patient preferences and beliefs were not associated with the intensity or number of chemotherapy regimens. [ABSTRACT FROM AUTHOR]

The increased incidence of ALS in military veterans of the first Persian Gulf War raised speculation that they may have a 'Persian Gulf' variant of ALS with atypical clinical features. Medical records of military veterans with ALS, previously identified in our epidemiological study, were evaluated for clinical features (age and site of onset, race, unexplained atypical findings) and ventilator-free survival. Comparisons between deployed versus non-deployed cohorts were made with deployment status based on designation by the Department of Defense Manpower Data Center (DMDC) or by self-report. Other than the young age of onset in both cohorts (40.8 years overall mean; 40.1 years for DMDC deployed, 41.2 years for DMDC non-deployed), review of the medical records failed to document any atypical features. After adjusting for bulbar onset, median survival from symptom onset in those ≥40 years of age was 35.5 months (2.96 years) compared to 64.7 months (5.39 years) in the group <40 years of age (hazard ratio (HR)=0.47, 95% CI 0.30-0.73, p=0.0006). After adjusting for age, median survival was 45.4 months (3.78 years) and 54.8 months (4.57 years) in bulbar- versus non-bulbar onset groups, respectively (HR=1.41, 95% CI 0.83-2.39, p=0.20). After adjusting for age and site of onset, deployed veterans had significantly shorter survival than non-deployed (40.2 vs. 57.0 months, HR=0.62, 95% CI 0.40-0.96, p=0.03) using DMDC data. In conclusion, although veterans developing ALS after deployment to the Persian Gulf in 1990-1991 exhibited otherwise typical clinical features, they experienced shorter ventilator-free survival than non-deployed veterans. [ABSTRACT FROM AUTHOR]

The article explores the effects of managed care restrictions on resource use on communication between patients and health care professionals. The results indicate that physicians met or offered alternatives for nearly 90 percent during previsit expectations for medications, tests or referrals. Patients generally received what they asked for and altered physician behavior nearly half of the time.

Purpose Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly prescribed drugs for the treatment of osteoarthritis (OA). While there are documented racial differences in the use of opioid analgesics, little is known about racial differences in the use of NSAIDs. Methods This was a retrospective cohort study among a national sample of 6038 veterans with OA. Patients were new NSAID users, followed for approximately 6 months. Primary outcomes included: type of NSAID prescribed (COX-2 selective or preferentially COX-2 selective NSAIDs vs other NSAIDs), days' supply of initial prescription and time to discontinuation of the index NSAID. Results In an analysis adjusted for demographic and gastrointestinal (GI) bleeding risk factors (age, sex, geographic region, history of GI bleeding, comorbid illnesses, use of anti-coagulants and glucocorticoids), Hispanics were less likely than whites to be prescribed an NSAID with some degree of COX-2 selectivity (odds ratio (OR): 0.47, p < 0.01). The days' supply of the initial prescription was lower for both blacks and Hispanics compared to whites (mean: 38, 31 and 43 days respectively, p < 0.01). In an analysis adjusted for demographics, GI bleeding risk factors and type of NSAID prescribed, blacks discontinued use of the index NSAID earlier than whites (hazard ratio = 1.19, p < 0.001) and there was a similar trend for Hispanics. Conclusion Minorities with OA were prescribed NSAIDs with less COX-2 selectivity and lower days' supply than whites. Further research should address underlying reasons and whether these differences impact outcomes such as pain control, side effects and cost-effectiveness of care. Published in 2003 by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

With increased access to biomedical and electronic health records data and the complexity of research questions, individuals in residency programmes who aim to conduct research require specialized educational programmes and biostatistics support. Biostatistics collaboration units in academic health centres often work with residents to conduct data‐intensive research. These units face numerous challenges related to providing training in statistical literacy and collaborating on resident‐led research within very restricted timelines. Since 2019, the Duke Biostatistics, Epidemiology, and Research Design (BERD) Methods Core has supported over 247 resident‐led projects by developing tools and resources to address these challenges. This manuscript presents novel processes and training materials that other institutions can use to help biostatistics collaboration units effectively support resident training programmes. We provide a framework to support the development of collaborative teams, along with specialized training materials for residents who collaborate with these teams. [ABSTRACT FROM AUTHOR]

Background: Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies. Objective: This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement. Methods: The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%). Results: Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement. Conclusions: Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention. [ABSTRACT FROM AUTHOR]

The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate different approaches to data collection or outcome measurement. However, pilot trials are unreliable for assessing treatment efficacy due to the statistical phenomenon called sampling variability. In this tutorial we use computer simulation to demonstrate the influence of sampling variability on efficacy estimates from pilot trials, illustrating why pilot trial designs should not be used to evaluate whether a treatment is promising or not. We simulate a 2-arm parallel group trial (N=20 per group) with a survival outcome as an example. Simulations are done under two scenarios: 1) the treatment is efficacious at the level of a hypothetical minimum clinically important difference (hazard ratio [HR] = 0.75); and 2) the treatment is not efficacious (HR=1). As expected, in both simulated scenarios the range of observed results is distributed around the true treatment effect, HR=0.75 or HR=1. Importantly, ∼20% of trials simulated under scenario 1 incorrectly suggest the treatment may be harmful (HR > 1). Under scenario 2, half of the simulated studies incorrectly suggest the treatment is beneficial. Treatment effect estimates from pilot trials should not be used to make future development decisions regarding a novel therapy because of the high risk of misleading conclusions. [ABSTRACT FROM AUTHOR]

Health effects associated with particulate matter (PM) show seasonal variations. We hypothesized that these heterogeneous effects may be attributed partly to the differences in the elemental composition of PM. Normal human bronchial epithelial (NHBE) cells and alveolar macrophages (AMs) were exposed to equal mass of coarse [PM with aerodynamic diameter of 2.5–10 μm (PM2.5–10)], fine (PM2.5), and ultrafine (PM < 0.1) ambient PM from Chapel Hill, North Carolina, during October 2001 (fall) and January (winter), April (spring), and July (summer) 2002. Production of interleukin (IL)-8, IL-6, and reactive oxygen species (ROS) was measured. Coarse PM was more potent in inducing cytokines, but not ROSs, than was fine or ultrafine PM. In AMs, the October coarse PM was the most potent stimulator for IL-6 release, whereas the July PM consistently stimulated the highest ROS production measured by dichlorofluorescein acetate and dihydrorhodamine 123 (DHR). In NHBE cells, the January and the October PM were consistently the strongest stimulators for IL-8 and ROS, respectively. The July PM increased only ROS measured by DHR. PM had minimal effects on chemiluminescence. Principal-component analysis on elemental constituents of PM of all size fractions identified two factors, Cr/Al/Si/Ti/Fe/Cu and Zn/As/V/Ni/Pb/Se, with only the first factor correlating with IL-6/IL-8 release. Among the elements in the first factor, Fe and Si correlated with IL-6 release, whereas Cr correlated with IL-8 release. These positive correlations were confirmed in additional experiments with PM from all 12 months. These results indicate that elemental constituents of PM may in part account for the seasonal variations in PM-induced adverse health effects related to lung inflammation. [ABSTRACT FROM AUTHOR]

Importance: The natural history of C. difficile progression in nucleic acid amplification test (NAAT) positive, toxin enzyme immunoassay-negative patients remains poorly described. Better understanding risk for subsequent disease may improve prevention strategies., Objective: Describe the natural history of C. difficile NAAT+/toxin- adults., Design: A cohort of adults (≥18 years) tested for C. difficile within Duke University Health System between 15 March 2020 and 31 December 2023 were classified as NAAT-, NAAT+/toxin-, or NAAT+/toxin+ and followed up to 90 days. Three time-to-event analyses were conducted. Incidence of toxin+ episodes was assessed by initial test status (analysis 1). Treatment of NAAT+/toxin- adults was described using cumulative incidence curves (analysis 2). Rates of toxin+ episodes and severe disease were compared between treated and untreated NAAT+/toxin- adults (analysis 3)., Results: The cohort included 24,474 tests and 440 toxin+ episodes among 18,337 unique subjects followed for a median 71 days. NAAT+/toxin- status was associated with subsequent toxin positivity (adjusted hazard ratio, aHR 5.06, 95% CI 3.61-7.10) - especially after antibiotic receipt (aHR 15.71, 95% CI 9.85-25.06). Among 2,334 NAAT+/toxin- episodes, 33% received presumptive treatment. Just 5% of NAAT+/toxin- subjects progressed to toxin positivity. Presumptive treatment was associated with lower hazard of subsequent toxin positivity (aHR 0.12, 95% CI 0.05-0.29) but not fulminant disease (aHR 1.93, 95% CI 0.50-7.45)., Conclusions and Relevance: C. difficile NAAT+/toxin- status was associated with subsequent toxin positivity, especially after antibiotic receipt, though absolute risk was low overall. Further research is needed to determine whether and for whom presumptive treatment might be beneficial., (© The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies., Objective: This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement., Methods: The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%)., Results: Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement., Conclusions: Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention., Trial Registration: ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X)., (©Pao-Hwa Lin, Steven Grambow, Stephen Intille, John A Gallis, Tony Lazenka, Hayden Bosworth, Corrine L. Voils, Gary G Bennett, Bryan Batch, Jenifer Allen, Leonor Corsino, Crystal Tyson, Laura Svetkey. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 18.10.2018.)

Introduction: It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from 'fundamental' (necessary for all) to 'specialized' (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized., Methods: We surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by 'fundamental' and 'specialized.', Results: There were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one's own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%)., Conclusion: We have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.

We describe the computer use characteristics of 406 post-myocardial infarction (MI) patients and their willingness to engage online for health communication and monitoring. Most participants were computer users (n = 259; 63.8%) and half (n = 209; 51.5%) read health information online at least monthly. However, most participants did not go online to track health conditions (n = 283; 69.7%), look at medical records (n = 287; 70.7%), or e-mail doctors (n = 351; 86.5%). Most participants would consider using a Web site to e-mail doctors (n = 275; 67.7%), share medical information with doctors (n = 302; 74.4%), send biological data to their doctor (n = 308; 75.9%), look at medical records (n = 321; 79.1%), track health conditions (n = 331; 81.5%), and read about health conditions (n = 332; 81.8%). Sharing health information online with family members (n = 181; 44.6%) or for support groups (n = 223; 54.9%) was not of much interest. Most post-MI participants reported they were interested in communicating with their provider and tracking their health conditions online. Because patients with a history of MI tend to be older and are disproportionately minority, researchers and clinicians must be careful to design interventions that embrace post-MI patients of diverse backgrounds that both improve their access to care and health outcomes.

Objectives: Efficient resource use is relevant in all healthcare systems. Although colorectal cancer is common, little has been published regarding the utilization of clinical resources in diagnosis., Study Design: The primary aim was to evaluate the patterns and factors associated with clinical services used to diagnose colorectal cancer at 14 US Department of Veterans Affairs facilities. The secondary aim was to investigate whether using more clinical services was associated with time to diagnosis., Methods: We reviewed medical records for 449 patients with colorectal cancer in an observational study. Study end points were the use of clinical diagnostic services grouped as laboratory tests, imaging studies, and subspecialty consultations. Cumulative logistic regression models were used to explore factors associated with each outcome., Results: Facility variability contributed to the variability of resource use in all models. In adjusted analyses, older patients had higher use of laboratory tests (odds ratio [OR], 1.20; 95% confidence interval [CI], 1.02-1.43) and incidentally discovered colorectal cancer was associated with increased use of consultations (OR, 1.97; 95% CI, 1.27-3.05), imaging studies (OR, 1.70; 95% CI, 1.12-2.58), and laboratory tests (OR, 3.14; 95% CI, 2.06-4.77) compared with screen-detected cancers. There was a strong direct correlation between thenumber of diagnostic services performed and the median time to diagnosis (Spearman correlation coefficient, 0.99; P < .001)., Conclusions: Variability in utilization of diagnostic clinical services was associated with patient age, patient presentation, and facility. Increased resource use was highly correlated with increased time to diagnosis.

The aim of this study was to perform a cost minimization analysis of store-and-forward teledermatology compared to a conventional dermatology referral process (usual care). In a Department of Defense (DoD) setting, subjects were randomized to either a teledermatology consult or usual care. Accrued healthcare utilization recorded over a 4-month period included clinic visits, teledermatology visits, laboratories, preparations, procedures, radiological tests, and medications. Direct medical care costs were estimated by combining utilization data with Medicare reimbursement rates and wholesale drug prices. The indirect cost of productivity loss for seeking treatment was also included in the analysis using an average labor rate. Total and average costs were compared between groups. Teledermatology patients incurred $103,043 in total direct costs ($294 average), while usual-care patients incurred $98,365 ($283 average). However, teledermatology patients only incurred $16,359 ($47 average) in lost productivity cost while usual-care patients incurred $30,768 ($89 average). In total, teledermatology patients incurred $119,402 ($340 average) and usual-care patients incurred $129,133 ($372 average) in costs. From the economic perspective of the DoD, store-and-forward teledermatology was a cost-saving strategy for delivering dermatology care compared to conventional consultation methods when productivity loss cost is taken into consideration.

Carrying the cytosine-adenosine (CA)19 repeat polymorphism in insulin-like growth factor-1 (IGF1) is associated with lower serum proteins and decreased prostate cancer risk. Carrying the -202A/C genotype in insulin-like growth factor binding protein-3 (IGFBP3) also has been associated with lower serum levels of the binding protein. However, the association between this variant and prostate cancer is inconsistent. To test the hypothesis that inconsistencies are partly due to cancer grade-specific differences in strength and direction of associations, we reanalyzed data from our previous Durham Veterans Administration Hospital study of blacks and whites comprising 47 cases (19 African Americans) with Gleason sum > or = 7, 50 cases (30 African Americans) with Gleason sum < 7 and 93 controls (49 African Americans). Compared to controls, the association between carrying the IGFBP3 C allele and prostate cancer risk was in OR(Low-Gleason) = 4.0; 95% CI: 1.4-12.3 compared to OR(High-Gleason) = 1.0; 95% CI: 0.4-2.2. Association patterns were similar in African Americans (OR(Low-Gleason) = 3.6; 95% CI: 1.0-13.2 vs. OR(High-Gleason) = 1.4; 95% CI: 0.4-2.3) and whites (OR(Low-Gleason) = 5.6; 95% CI: 0.6-49.0 vs. OR(High-Gleason) = 0.6; 95% CI: 0.2-2.2). The inverse association between carrying the IGF1 (CA)19 repeat variant did not vary by grade or ethnicity. If confirmed in larger studies, these findings support the hypothesis that the association between IGFBP3 C allele and prostate cancer is grade specific in both ethnic groups.