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1.  A Randomized Trial of Genetic and Environmental Risk Assessment (GERA) for Colorectal Cancer Risk in Primary Care: Trial Design and Baseline Findings 
Contemporary clinical trials  2010;32(1):25-31.
This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening.
The trial includes asymptomatic patients who are 50-79 years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA Group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at one and six months. A chart audit is performed at six months.
Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59 years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC.
One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback.
PMCID: PMC3006063  PMID: 20828635
decision making; colorectal neoplasms; mass screening; risk assessment; genetic screening
2.  Effectiveness of Complete Diagnostic Examination in Clinical Practice Settings 
Cancer detection and prevention  2006;30(6):545-551.
Thorough follow-up of a positive fecal occult blood test (FOBT) result, or a complete diagnostic evaluation (CDE), is recommended as routine care on the basis of findings from colorectal cancer (CRC) screening trials. CDE involves either colonoscopy or the combination of flexible sigmoidoscopy and double contrast barium enema x-ray. However, little evidence outside clinical screening trial settings has been reported in the literature to support CDE performance. The focus of this study was to determine the impact of CDE in primary care practice settings.
We determined diagnostic outcomes for 461 adult patients with a positive FOBT result in 318 primary care practices in southeastern Pennsylvania and southern New Jersey. Sociodemographic data were collected and CDE status was ascertained for these patients. Polytomous logistic regression models were used to identify whether having CDE was associated with subsequently being diagnosed with lower gastrointestinal “neoplastic disease” or “other gastrointestinal disease” as compared to “normal findings.”
Patients who underwent CDE were significantly more likely to have a reported diagnosis of colorectal neoplasia than normal findings (adjusted odds ratio = 3.65, 95% confidence interval = 1.58-8.39, p=0.02). CDE performance did not result in the differential diagnosis of other gastrointestinal disease.
Patients with a positive screening FOBT who underwent CDE were more likely to be diagnosed with colorectal neoplasia than with less serious conditions or have normal findings. Results support the use of CDE in CRC screening.
PMCID: PMC1861814  PMID: 17113240
Colorectal neoplasm; occult blood; fecal occult blood test; mass screening; cancer screening; follow-up studies; complete diagnostic evaluation; abnormal findings; chart audit; diagnosis
3.  Preparing African-American men in community primary care practices to decide whether or not to have prostate cancer screening. 
BACKGROUND: This study was a randomized trial to test the impact of an informed decision-making intervention on prostate cancer screening use. METHODS: The study population included 242 African-American men from three primary care practices who were 40-69 years of age and had no history of prostate cancer. Participants completed a baseline survey questionnaire and were randomly assigned either to a Standard Intervention (SI) group (N=121) or an Enhanced Intervention (EI) group (N=121). An informational booklet was mailed to both groups. EI group men were also offered a screening decision education session. Two outcomes were considered: (1) complete screening (i.e., having a digital rectal exam (DRE) and prostate specific antigen (PSA) testing), and (2) complete or partial screening (i.e., having a PSA test with or without DRE). An endpoint chart audit was performed six months after initial intervention contact. The data were analyzed via exact logistic regression. RESULTS: Overall, screening use was low among study participants. EI group men had a screening frequency two times greater than that of SI group men, but the difference was not statistically significant: 8% vs. 4 % (OR = 1.94) fo rcomplete screening, and 19% vs. 10% (OR = 2.08) for complete or partial screening. Multivariable analyses showed that being in the EI group and primary care practice were significant predictors of complete or partial screening (OR = 3.9 and OR = 5.64, respectively). CONCLUSION: Prostate cancer screening use may be influenced by exposure to decision education and the influence of screening-related primary care practice factors.
PMCID: PMC2576013  PMID: 16173330
4.  The effect of ethnicity and maternal birthplace on small-for-gestational-age deliveries to HIV-infected women 
To examine the relative role of ethnicity and maternal birthplace on small-for-gestational-age (SGA) deliveries of a cohort of mothers in New York who were infected with human immunodeficiency virus.
Medicaid claims and linked vital statistics records were examined for 2,525 singleton deliveries to HIV-infected women from 1993 through 1996. We estimated adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of SGA delivery associated with ethnicity (i.e., white, white-Latina, black, and black-Latina) and maternal birthplace (i.e., native US/Puerto Rican vs. foreign born) in a series of multivariate regression models to which we sequentially added demographic, health services, and lifestyle factors (i.e., alcohol, tobacco, and illicit drug use).
Of the deliveries, 10% were SGA. The odds of SGA infants for black and white women did not differ by maternal birthplace. Foreign-born white-Latinas and black-Latinas had lower unadjusted odds of a SGA delivery than their US-born counterparts (OR 0.29, CI 0.14, 0.61 and OR 0.22, CI 0.07, 0.71, respectively). After adjustment for maternal lifestyle characteristics, the odds of SGA delivery were 0.50 (CI 0.23, 1.09) for white-Latina mothers and 0.60 (CI 0.17, 2.08) for black-Latina mothers.
SGA outcomes did not differ by maternal birthplace for black and white women. Differences in lifestyle factors appear to contribute to lower odds of SGA delivery for foreign-born versus US-born white- and black-Latina HIV-infected women.
PMCID: PMC3456377  PMID: 11937623
African American; Hispanic American; HIV Infection; Medicaid; Small for Gestational Age; Substance Abuse-Related Disorders
5.  Clinic HIV-Focused Features and Prevention of Pneumocystis Carinii Pneumonia 
To examine the association of clinic HIV-focused features and advanced HIV care experience with Pneumocystis carinii pneumonia (PCP) prophylaxis and development of PCP as the initial AIDS diagnosis.
Nonconcurrent prospective study.
New York State Medicaid Program.
Medicaid enrollees diagnosed with AIDS in 1990–1992.
We collected patient clinical and health care data from Medicaid files, conducted telephone interviews of directors of 125 clinics serving as the usual source of care for study patients, and measured AIDS experience as the cumulative number of AIDS patients treated by the study clinics since 1986. Pneumocystis carinii pneumonia prophylaxis in the 6 months before AIDS diagnosis and PCP at AIDS diagnosis were the main outcome measures. Bivariate and multivariate analyses adjusted for clustering of patients within clinics. Of 1,876 HIV-infected persons, 44% had PCP prophylaxis and 38% had primary PCP. Persons on prophylaxis had 20% lower adjusted odds of developing PCP (95% confidence interval [CI] 0.64, 0.99). The adjusted odds of receiving prophylaxis rose monotonically with the number of HIV-focused features offered by the clinic, with threefold higher odds (95% CI 1.6, 5.7) for six versus two or fewer such features. Patients in clinics with three HIV-focused features had 36% lower adjusted odds of PCP than those in clinics with one or none. Neither clinic experience nor specialty had a significant association with prophylaxis or PCP.
PCP prevention in our study cohort appears to be more successful in clinics offering an array of HIV-focused features.
PMCID: PMC1496898  PMID: 9462490
Pneumocystis carinii pneumonia (PCP); AIDS; clinical competence; ambulatory care; case management

Results 1-5 (5)