John M. McLaughlin

Recruitment of minority and underserved populations in the United States: The centers for population health and health disparities experience

OBJECTIVE The recruitment of minority and underserved individuals to research studies is often problematic. The purpose of this study was to describe the recruitment experiences of projects that actively recruited minority and underserved populations as part of The Centers for Population Health and Health Disparities (CPHHD) initiative. METHODS Principal investigators and research staff from 17 research projects at eight institutions across the United States were surveyed about their recruitment experiences. Investigators reported the study purpose and design, recruitment methods employed, recruitment progress, problems or challenges to recruitment, strategies used to address these problems, and difficulties resulting from Institutional Review Board (IRB) or Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements. Additionally, information was collected about participant burden and compensation. Burden was classified on a three-level scale. Recruitment results were reported as of March 31, 2007. RESULTS Recruitment attainment ranged from 52% to 184% of the participant recruitment goals. Commonly reported recruitment problems included administrative issues, and difficulties with establishing community partnerships and contacting potential participants. Long study questionnaires, extended follow-up, and narrow eligibility criteria were also problematic. The majority of projects reported difficulties with IRB approvals, though few reported issues related to HIPAA requirements. Attempted solutions to recruitment problems varied across Centers and included using multiple recruitment sites and sources and culturally appropriate invitations to participate. Participant burden and compensation varied widely across the projects, however, accrual appeared to be inversely associated with the amount of participant burden for each project. CONCLUSION Recruitment of minority and underserved populations to clinical trials is necessary to increase study generalizbility and reduce health disparities. Our results demonstrate the importance of flexible study designs which allow adaptation to recruitment challenges. These experiences also highlight the importance of involving community members and reducing participant burden to achieve success in recruiting individuals from minority and underserved populations.

Effect on Survival of Longer Intervals Between Confirmed Diagnosis and Treatment Initiation Among Low-Income Women With Breast Cancer

PURPOSE To determine the impact of longer periods between biopsy-confirmed breast cancer diagnosis and the initiation of treatment (Dx2Tx) on survival. PATIENTS AND METHODS This study was a noninterventional, retrospective analysis of adult female North Carolina Medicaid enrollees diagnosed with breast cancer from January 1, 2000, through December, 31, 2002, in the linked North Carolina Central Cancer Registry-Medicaid Claims database. Follow-up data were available through July 31, 2006. Cox proportional hazards regression models were constructed to evaluate the impact on survival of delaying treatment ≥ 60 days after a confirmed diagnosis of breast cancer. RESULTS The study cohort consisted of 1,786 low-income, adult women with a mean age of 61.6 years. A large proportion of the patients (44.3%) were racial minorities. Median time from biopsy-confirmed diagnosis to treatment initiation was 22 days. Adjusted Cox proportional hazards regression showed that although Dx2Tx length did not affect survival among those diagnosed at early stage, among late-stage patients, intervals between diagnosis and first treatment ≥ 60 days were associated with significantly worse overall survival (hazard ratio [HR], 1.66; 95% CI, 1.00 to 2.77; P = .05) and breast cancer-specific survival (HR, 1.85; 95% CI, 1.04 to 3.27; P = .04). CONCLUSION One in 10 women waited ≥ 60 days to initiate treatment after a diagnosis of breast cancer. Waiting ≥ 60 days to initiate treatment was associated with a significant 66% and 85% increased risk of overall and breast cancer-related death, respectively, among late-stage patients. Interventions designed to increase the timeliness of receiving breast cancer treatments should target late-stage patients, and clinicians should strive to promptly triage and initiate treatment for patients diagnosed at late stage.

Psychosocial predictors of adherence to risk-appropriate cervical cancer screening guidelines: A cross sectional study of women in Ohio Appalachia participating in the Community Awareness Resources and Education (CARE) project

OBJECTIVE We describe factors, in the context of the Social Determinants of Health model, associated with receiving Pap smears within risk-appropriate guidelines (i.e., guidelines that specify screening intervals based upon a womans individual risk of developing cervical cancer). METHODS Completed in June 2006, we conducted a cross-sectional survey of women from 14 health clinics in Ohio Appalachia pertaining to psychosocial, demographic, biological, and health-related factors. A logistic regression model was constructed to predict whether or not a woman was within risk-appropriate cervical cancer screening guidelines. RESULTS Of 562 women with a date of last Pap smear, 380 (68%) were within risk-appropriate guidelines. Logistic regression showed that, compared to women with low-level SES, women with middle- and high-level SES had 3.39 [1.85, 6.21] and 3.86 [2.03, 7.34] times the odds, respectively, of being within risk-appropriate guidelines. Odds of being within guidelines increased 1.09 [1.04, 1.15] fold for each decrease of one major life event. Additionally, women that were financially better off or financially worse off than their parents at the same age had lower odds (0.41 [0.23, 0.73] and 0.49 [0.24, 0.98], respectively) of being within guidelines than women who reported their finances were the same as their parents. Results also showed an interaction between marital status and age at first intercourse (p=0.001). CONCLUSION The results suggest an impact of psychosocial factors on Pap smear testing behaviors, and illustrate the need to examine risk-appropriate interventions to improve screening.

Evaluating the Efficacy of Lay Health Advisors for Increasing Risk-appropriate Pap Test Screening: A randomized controlled trial among Ohio Appalachian women

Background: Cervical cancer is a significant health disparity among women in Ohio Appalachia. The goal of this study was to evaluate the efficacy of a lay health advisor (LHA) intervention for improving Papanicolaou (Pap) testing rates, to reduce cervical cancer, among women in need of screening. Methods: Women from 14 Ohio Appalachian clinics in need of a Pap test were randomized to receive either usual care or an LHA intervention over a 10-month period. The intervention consisted of two in-person visits with an LHA, two phone calls, and four postcards. Both self-report and medical record review (MRR) data (primary outcome) were analyzed. Results: Of the 286 women, 145 and 141 were randomized to intervention and usual care arms, respectively. According to MRR, more women in the LHA arm had a Pap test by the end of the study compared with those randomized to usual care (51.1% vs. 42.0%; OR = 1.44, 95% CI: 0.89–2.33; P = 0.135). Results of self-report were more pronounced (71.3% vs. 54.2%; OR = 2.10, 95% CI: 1.22–3.61; P = 0.008). Conclusions: An LHA intervention showed some improvement in the receipt of Pap tests among Ohio Appalachian women in need of screening. Although biases inherent in using self-reports of screening are well known, this study also identified biases in using MRR data in clinics located in underserved areas. Impact: LHA interventions show promise for improving screening behaviors among nonadherent women from underserved populations. Cancer Epidemiol Biomarkers Prev; 20(5); 835–43. ©2011 AACR.

Adherence and asthma control with mometasone furoate versus fluticasone propionate in adolescents and young adults with mild asthma

Introduction. Because adherence to asthma controller medication among adolescents and young adults is poor but critical for asthma control, strategies are needed to improve adherence. One strategy is to reduce the number of daily doses necessary to maintain adequate control. Mometasone furoate delivered through a dry powder inhaler (MF-DPI) is an inhaled corticosteroid (ICS) approved for once-daily dosing in most patients. Fluticasone propionate (FP) is an ICS approved for twice-daily dosing. A retrospective claims analysis was performed to assess treatment adherence and markers of asthma control in adolescent and young adult patients with mild asthma who began treatment with MF-DPI or FP. Methods. Data from approximately 37 million patients in an administrative insurance claims database in the United States were analyzed. Patients, 12–25 years, with mild asthma and previous asthma medication use were assigned an index date based on their first prescription fill of MF-DPI or FP between 1 January 2005 and 10 October 2008. Demographics, prescription claims, and health care utilization data were captured in the 365-day period before (preindex) and after (postindex) the index date. Patients from each cohort were propensity score-matched 1:1 based on preindex data. Adherence was measured by prescription fills and percentage of days covered (PDC); asthma control was measured by exacerbations and short-acting β2-agonist (SABA) canister claims. Bivariate and multivariate generalized linear model (GLM) analyses were conducted to determine differences in outcomes between the cohorts. Results. After matching, 692 patients per group (average age – 16 years) were analyzed. Adherence in the postindex period was significantly higher in the MF-DPI cohort compared with the FP cohort as measured by PDC (23.5% vs. 14.5%; p< .0001) and prescription fills (2.70 vs. 1.91; p< .0001). The mean number of postindex SABA canister claims was significantly lower in the MF-DPI cohort compared with the FP cohort (1.04 vs. 1.40; p< .0001). There was no significant difference in the mean number of postindex exacerbations between the cohorts. Conclusion. Adolescent/young adult patients with mild asthma who received MF-DPI had better postindex adherence and fewer SABA canister claims than patients receiving FP.

Marital Status and Stage at Diagnosis of Cutaneous Melanoma: Results From the Surveillance Epidemiology and End Results (SEER) Program, 1973-2006

We evaluated the effect of marital status on risk of late‐stage cutaneous melanoma diagnosis.

Effects of Tomato- and Soy-Rich Diets on the IGF-I Hormonal Network: A Crossover Study of Postmenopausal Women at High Risk for Breast Cancer

To determine whether dietary modifications with tomato products and/or a soy supplement affected circulating levels of insulin-like growth factor (IGF)-1 and other markers of cell signaling in postmenopausal women at risk for developing breast cancer. Eligible and consented postmenopausal women at high risk for developing breast cancer were enrolled in a 26-week, two-arm (tomato and soy, 10 weeks each) longitudinal dietary intervention study in which each woman served as her own control. Changes in biochemical endpoints including IGF-I, IGF-binding protein (IGFBP)-3, estradiol, sex hormone–binding globulin (SHBG), C-peptide, and insulin were measured for each intervention arm. Carotenoid and isoflavone levels were measured to assess adherence. Significant increases in carotenoid and isoflavone levels during the tomato and soy study arms, respectively, suggested that women were adherent to both arms of the intervention. The tomato-rich diet had little effect on cell-signaling biomarkers previously associated with breast cancer risk. However, results of the soy intervention showed that concentrations of IGF-I and IGFBP-3 increased by 21.6 and 154.7 μmol/L, respectively (P = 0.001 for both) and SHBG decreased by 5.4 μmol/L (P < 0.001) after consumption of the soy protein supplement. Increased soy protein intake may lead to small, but significant, increases in IGF-I and IGFBP-3. Soy consumption also led to a significant decrease in SHBG, which has been hypothesized to promote, rather than prevent, cancer growth. Previous epidemiologic studies, however, have confirmed protective effect of soy on breast cancer. Additional investigation about the effect of soy on breast cancer risk and its mechanism of action is warranted. Cancer Prev Res; 4(5); 702–10. ©2011 AACR.

Patient and Provider Determinants Associated With the Prescription of Adjuvant Hormonal Therapies Following a Diagnosis of Breast Cancer in Medicaid-Enrolled Patients

PURPOSE This study examined patient and provider characteristics associated with being prescribed an aromatase inhibitor (AI) vs tamoxifen-only therapy among a cohort of postmenopausal North Carolina Medicaid enrollees diagnosed with hormone receptor-positive breast cancer. METHODS A logistic regression model was built to determine the odds of an individual ever receiving an AI during the study period using data from the Linked North Carolina Central Cancer Registry-Medicaid Claims database. RESULTS A total of 452 patients were included, of which 307 (67.9%) and 145 (32.1%) received tamoxifen only and AI (alone or in combination) therapy, respectively. Results of the final logistic model revealed that odds of receiving an AI generally increased over the study period; however, patients who lived in urban areas had 1.86 (95% CI, 1.20-2.89) times the odds of ever receiving some form of AI therapy compared to patients who lived in rural areas. Additionally, patients with distant stage or unstaged breast cancer (opposed to local stage) had 2.15 (95% CI, 1.39-3.32) times the odds of ever receiving an AI. CONCLUSIONS Results suggest that the use of AI therapy is becoming more widespread over time; however, differences in the type of antiestrogenic treatment prescribed based on urban/rural status may represent disparities in access to advanced care. Furthermore, it may be the case that women with local-stage breast cancer are not being treated aggressively enough with novel antiestrogenic drug therapies.