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Amy S Mudano,1,2,3 Lisa C Gary,1,2,3 Ana L Oliveira,1,2,3 Mary Melton,1,2,3 Nicole C Wright,1,2,3 Jeffrey R Curtis,1,2,3 Elizabeth Delzell,1,2,3 T Michael Harrington,1,2,3 Meredith L Kilgore,1,2,3 Cora Elizabeth Lewis,1,2,3 Jasvinder A Singh,1,2,3,4 Amy H Warriner,1,2,3 Wilson D Pace,5 Kenneth G Saag1,2,31Center for Education and Research on Therapeutics (CERTs), 2Center for Outcomes Effectiveness Research and Education (COERE), and 3Center for Clinical and Translational Sciences (CCTS), (University of Alabama at Birmingham, Birmingham, AL, USA); 4Veterans Affairs Medical Center, Birmingham, AL, USA; 5Distributed Ambulatory Research in Therapeutics Network (DARTNet), American Academy of Family Physicians (AAFP), University of Colorado, Denver, CO, USAIntroduction: Pragmatic clinical trials (PCTs) provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS) for patient recruitment and screening for an osteoporosis PCT in community physician offices.Materials and methods: We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.Results: A total of 160 women (80% of those approached) agreed to complete the osteoporosis screening questions in ten family physicians’ offices. Women using the tablet computer were able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician's office compared to those using IVRS. Using the proportion of women found to be eligible in this study (almost 20%) and other eligibility scenarios, we determined that between 240 and 670 community physician offices would be needed to recruit ample patients for our hypothetical study.Conclusion: We found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings. In addition, we used this experience to estimate the number of research sites needed for such a study.Keywords: osteoporosis, clinical trial, pragmatic clinical trials, computer applications

Context: Although tumor necrosis factor (TNF)-α antagonists are increasingly used in place of nonbiologic comparator medications, their safety profile remains incomplete.Objectives: To determine whether initiation of TNF-α antagonists compared with nonbiologic comparators is associated with an increased risk of serious infections requiring hospitalization.Design, Setting, and Patients: Within a US multi-institutional collaboration, we assembled retrospective cohorts (1998-2007) of patients with rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis, psoriatic arthritis, or ankylosing spondylitis (psoriasis and spondyloarthropathies) combining data from Kaiser Permanente Northern California, New Jersey and Pennsylvania Pharmaceutical Assistance programs, Tennessee Medicaid, and national Medicaid/Medicare. TNF-α antagonists and nonbiologic regimens were compared in disease-specific propensity score (PS)-matched cohorts using Cox regression models with nonbiologics as the reference. Baseline glucocorticoid use was evaluated as a separate covariate.Main Outcome Measure: Infections requiring hospitalization (serious infections) during the first 12 months after initiation of TNF-α antagonists or nonbiologic regimens.Results: Study cohorts included 10,484 RA, 2323 IBD, and 3215 psoriasis and spondyloarthropathies matched pairs using TNF-α antagonists and comparator medications. Overall, we identified 1172 serious infections, most of which (53%) were pneumonia and skin and soft tissue infections. Among patients with RA, serious infection hospitalization rates were 8.16 (TNF-α antagonists) and 7.78 (comparator regimens) per 100 person-years (adjusted hazard ratio [aHR], 1.05 [95% CI, 0.91-1.21]). Among patients with IBD, rates were 10.91 (TNF-α antagonists) and 9.60 (comparator) per 100 person-years (aHR, 1.10 [95% CI, 0.83-1.46]). Among patients with psoriasis and spondyloarthropathies, rates were 5.41 (TNF-α antagonists) and 5.37 (comparator) per 100 person-years (aHR, 1.05 [95% CI, 0.76-1.45]). Among patients with RA, infliximab was associated with a significant increase in serious infections compared with etanercept (aHR, 1.26 [95% CI, 1.07-1.47]) and adalimumab (aHR, 1.23 [95% CI, 1.02-1.48]). Baseline glucocorticoid use was associated with a dose-dependent increase in infections.Conclusion: Among patients with autoimmune diseases, compared with treatment with nonbiologic regimens, initiation of TNF-α antagonists was not associated with an increased risk of hospitalizations for serious infections. [ABSTRACT FROM AUTHOR]

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Quantitative estimates of exposure to 1,3-butadiene (BD), styrene (STY), and dimethyldithiocarbamate (DMDTC) were developed for a follow-up study of workers at six North American synthetic rubber plants. Procedures entailed identifying tasks and jobs involving exposure, identifying factors influencing historical changes in exposure potential, and using mathematical models to calculate job- and time-period-specific exposures. Exposure metrics included 8-hour time-weighted average (TWA) intensity, the annual number of peak exposures (BD: >100 ppm, STY: >50 ppm) and TWA intensity below and above the peak threshold. The 5th and 95th percentiles of the approximate probability distribution of each exposure estimate served as its 90% uncertainty interval. Job- and year-specific estimates were linked with subjects' work histories to obtain cumulative exposure indices. Exposure estimates varied among tasks, jobs, plants, and time periods. BD TWAs were approximately 10 ppm during the 1940s-1960s and declined during the 1970s and 1980s. STY TWAs were always <2 ppm. DMDTC exposure began in the 1950s, was high through the 1960s, and later declined. BD peak exposure accounted for a large proportion of cumulative BD exposure, whereas almost none of the STY exposure was experienced at levels >50 ppm. Exposure indices were correlated. Exposures were higher than previously estimated. Multiple correlations among DMDTC, BD, and STY exposure estimates make it difficult to estimate agent-specific effects. Limitations of the methodology include the potential inaccuracy of the estimates, the lack of adequate industrial hygiene data to validate the estimates, the additional inaccuracy of linkage with poorly specified job groups, and the potential for differential exposure misclassification because the jobs and work areas where excess leukemia mortality occurred were well-known at the time of this study. Nevertheless, the new exposure estimates were highly correlated with the old, yielding equivalent exposure ranking of workers and were comparable to limited industrial hygiene data published by NIOSH. [ABSTRACT FROM AUTHOR]

This investigation evaluated the mortality experience of workers at a dye and resin manufacturing plant in New Jersey. The retrospective follow-up study included 3266 workers employed for at least 6 months at the plant. Plant production areas were South Dyes, where anthraquinone dyes and intermediates were produced; North Dyes, where azo dyes and intermediates were produced; and plastics and additives, where various resins and additives for plastics were made. Analyses used standardized mortality ratio (SMRs) to compare the cohort's cause-specific mortality rates during 1952 to 1995 with the rates of the New Jersey population. There were fewer than expected deaths from all causes combined (728 observed vs 810 expected) and similar numbers of observed and expected cancer deaths (225 vs 232). Statistically significant work area-specific cancer excesses were limited to white men and included an excess of lung cancer in Maintenance workers (40 observed vs 26 expected; SMR, 153; 95% confidence interval [CI], 109 to 208) and in South Dyes workers (32 observed vs 19 expected; SMR, 168; CI, 115 to 237) and an excess of stomach cancer (5 observed vs 1.3 expected; SMR, 386; CI, 125 to 901), bladder cancer (4 observed vs 0.8 expected; SMR, 515; CI, 140 to 1318) and central nervous system cancer (5 observed vs 1 expected; SMR, 517; CI, 168 to 1206) in North Dyes workers. None of these increases was concentrated in work area subgroups with long duration of employment and long potential induction time. It was concluded that the excess of bladder cancer probably was due to exposure to carcinogenic arylamines at another facility, where some employees had worked before coming to the study plant. The other cancer increases may be attributable to chance, to uncontrolled confounding by smoking, or to an unidentified occupational exposure. [ABSTRACT FROM AUTHOR]

Hodgkin's disease displays an intriguing variation in incidence with age. For adult disease, there is striking bimodality in incidence with peaks in young adulthood and in older adulthood. On epidemiologic grounds, there appear to be three different diseases: childhood (0-14 years), young adult (15-34 years), and older adult Hodgkin's disease (55+ years). There are marked geographic variations in Hodgkin's disease incidence, but the variations are different for the three age groups. There are also interesting associations between Hodgkin's disease and markers of social class. For the young adult disease, the higher the socioeconomic status of a person, the greater the Hodgkin's disease risk. Additionally, Hodgkin's disease patients appear to have had fewer of the childhood infectious diseases or to have had these diseases at older ages than controls. These factors suggest an analogy between young adult Hodgkin's disease and Epstein-Barr virus, poliomyelitis, and tuberculosis infections. Thus, the descriptive epidemiology of Hodgkin's disease suggests an infectious disease process underlying its etiology in young adulthood and perhaps in childhood. There is a curious relationship between Hodgkin's disease and Epstein-Barr virus infection. Persons with Epstein-Barr virus infection have an increased risk of developing Hodgkin's disease, and the Epstein-Barr virus infection precedes the development of Hodgkin's disease. The virus has never been isolated from or identified in Hodgkin's disease tissue. The mechanisms underlying this association are unknown and may provide important clues to the etiology of Hodgkin's disease and other lymphomas. It is likely that there is no direct person-to-person spread of Hodgkin's disease. This is suggested by several negative studies of linkages between cases, time-space clustering, and aggregation of exposures at schools. Studies have shown that neither physicians nor nurses, groups with greater likelihood of encountering Hodgkin's disease patients than the general public, have an increased risk. There appears to be familial aggregation of Hodgkin's disease. Siblings of young adult cases are at increased risk, whereas siblings of older adult cases have no increase in risk. Among sibling pairs with Hodgkin's disease, there is a marked excess of like-sex pairs. Like-sex siblings have almost twice the risk of discordant-sex siblings, suggesting an interaction between environmental and genetic factors. Thus, it would be of interest to known the risk to spouses of cases who share environments but who do not share genes.(ABSTRACT TRUNCATED AT 400 WORDS) [ABSTRACT FROM AUTHOR]