Peer education for secondary stroke prevention in inner-city minorities: Design and methods of the Prevent Recurrence of All Inner-city Strokes through Education randomized controlled trial

Background The highest risk for stroke is among survivors of strokes or transient ischemic attacks (TIA). However, use of proven-effective cardiovascular medications to control stroke risk is suboptimal, particularly among the Black and Latino populations disproportionately impacted by stroke. Methods A partnership of Harlem and Bronx community representatives, stroke survivors, researchers, clinicians, outreach workers and patient educators used community-based participatory research to conceive and develop the Prevent Recurrence of All Inner-city Strokes through Education (PRAISE) trial. Using data from focus groups with stroke survivors, they tailored a peer-led, community-based chronic disease self-management program to address stroke risk factors. PRAISE will test, in a randomized controlled trial, whether this stroke education intervention improves blood pressure control and a composite outcome of blood pressure control, lipid control, and use of antithrombotic medications. Results Of the 582 survivors of stroke and TIA enrolled thus far, 81% are Black or Latino and 56% have an annual income less than $15,000. Many (33%) do not have blood pressures in the target range, and most (66%) do not have control of all three major stroke risk factors. Conclusions Rates of stroke recurrence risk factors remain suboptimal in the high risk, urban, predominantly minority communities studied. With a community-partnered approach, PRAISE has recruited a large number of stroke and TIA survivors to date, and may prove successful in engaging those at highest risk for stroke and reducing disparities in stroke outcomes in inner-city communities

Effect of Peer Education on Stroke Prevention: The Prevent Recurrence of All Inner-City Strokes Through Education Randomized Controlled Trial

Background and Purpose—Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success. We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors. Methods—Between 2009 and 2012, we enrolled 600 stroke or transient ischemic attack survivors from diverse, low-income communities in New York City into a 2-arm randomized clinical trial that compared a 6 week (1 session/week), peer-led, community-based, stroke prevention self-management group workshop (N=301) to a wait-list control group (N=299). The primary outcome was the proportion with a composite of controlled blood pressure (<140/90 mm Hg), low-density lipoprotein cholesterol <100 mg/dL, and use of antithrombotic medications at 6 months. Secondary outcomes included control of the individual stroke risk factors. All analyses were by intent-to-treat. Results—There was no difference in the proportion of intervention and control group participants achieving the composite outcome (34% versus 34%; P=0.98). The proportion with controlled blood pressure at 6 months was greater in the intervention group than in the control group (76% versus 67%; P=0.02). This corresponded to a greater change in systolic blood pressure in the intervention versus control group (−3.63 SD, 19.81 mm Hg versus +0.34 SD, 23.76 mm Hg; P=0.04). There were no group differences in the control of cholesterol or use of antithrombotics. Conclusions—A low-cost peer education self-management workshop modestly improved blood pressure, but not low-density lipoprotein cholesterol or antithrombotic use, among stroke and transient ischemic attack survivors from vulnerable, predominantly minority urban communities

Correlates of Post-traumatic Stress Disorder in Stroke Survivors

Background Post-traumatic stress disorder (PTSD) can occur after life-threatening events, including illness, but correlates of PTSD after stroke or transient ischemic attack (TIA) have not been well described. Methods We measured the prevalence of stroke-induced PTSD with the PTSD Checklist Specific for stroke (PCL-S) in adults who had a stroke or TIA within 5 years. A PCL-S score of 50 or more indicated likely PTSD. We tested for potential predictors of stroke-associated PTSD, including demographics, stroke history, disability, medical comorbidities, depression, and emotional support and then examined the association between poststroke PTSD and measures of physical and mental health. Results Of 535 participants, 95 (18%) had a PCL-S score of 50 or more; the mean score was 35.4 ± 13.7 (range 17-80 of 85). In logistic regression analysis, low income (odds ratio [OR] 1.98, 95% confidence interval [CI] 1.01-3.61), recurrent stroke or TIA (OR 1.86, 1.10-3.16), more disability (OR 1.79, 1.43-2.23), and increased comorbidities (OR 1.90, 1.05-3.45) were independently associated with PTSD. Older age (OR .93, .90-.95), marriage or partnership (OR .52, .28-.98), and having emotional support (OR .25, .11-.54) were protective against developing PTSD. Participants with likely PTSD had worse physical and mental health. Conclusions In this racially and ethnically diverse cohort of stroke and TIA survivors, stroke-induced PTSD was associated with younger age, recurrent strokes, greater disability, and comorbidities. PTSD was associated with a substantially increased physical, mental, and quality of life burden in this already vulnerable population. Having social support was protective, suggesting a potential target for intervention

Posttraumatic Stress Disorder and Adherence to Medications in Survivors of Strokes and Transient Ischemic Attacks

Background and Purpose--Posttraumatic stress disorder (PTSD) can be triggered by life-threatening medical events such as strokes and transient ischemic attacks (TIAs). Little is known regarding how PTSD triggered by medical events affects patients' adherence to medications. Methods--We surveyed 535 participants, age ≥40 years old, who had at least 1 stroke or TIA in the previous 5 years. PTSD was assessed using the PTSD Checklist-Specific for stroke; a score ≥50 on this scale is highly specific for PTSD diagnosis. Medication adherence was measured using the 8-item Morisky scale. Logistic regression was used to test whether PTSD after stroke/TIA was associated with increased risk of medication nonadherence. Covariates for adjusted analyses included sociodemographics, Charlson comorbidity index, modified Rankin Scale score, years since last stroke/TIA, and depression. Results--Eighteen percent of participants had likely PTSD (PTSD Checklist-Specific for stroke ≥50), and 41% were nonadherent to medications according to the Morisky scale. A greater proportion of participants with likely PTSD were nonadherent to medications than other participants (67% versus 35%, P<0.001). In the adjusted model, participants with likely PTSD were nearly 3 times more likely (relative risk, 2.7; 95% CI, 1.7–4.2) to be nonadherent compared with participants without PTSD (PTSD Checklist-Specific for stroke <25) even after controlling for depression, and there was a graded association between PTSD severity and medication nonadherence. Conclusion--PTSD is common after stroke/TIA. Patients who have PTSD after stroke or TIA are at increased risk for medication nonadherence

Key Barriers to Medication Adherence in Survivors of Strokes and Transient Ischemic Attacks

Background: Even though medications can greatly reduce the risk of recurrent stroke, medication adherence is suboptimal in stroke survivors. Objective: To identify key barriers to medication adherence in a predominantly low-income, minority group of stroke and transient ischemic attack (TIA) survivors. Design: Cross-sectional study. Participants: Six hundred stroke or TIA survivors, age ≥ 40 years old, recruited from underserved communities in New York City. Main Measures: Medication adherence was measured using the 8-item Morisky Medication Adherence Questionnaire. Potential barriers to adherence were assessed using validated instruments. Logistic regression was used to test which barriers were independently associated with adherence. Models were additionally controlled for age, race/ethnicity, income, and comorbidity. Key Results: Forty percent of participants had poor self-reported medication adherence. In unadjusted analyses, compared to adherent participants, non-adherent participants had increased concerns about medications (26 % versus 7 %, p < 0.001), low trust in their personal doctor (42 % versus 29 %, p = 0.001), problems communicating with their doctor due to language (19 % versus 12 %, p = 0.02), perceived discrimination from the health system (42 % versus 22 %, p <0.001), difficulty accessing health care (16 % versus 8 %, p = 0.002), and inadequate continuity of care (27 % versus 20 %, p = 0.05). In the fully adjusted model, only increased concerns about medications [OR 5.02 (95 % CI 2.76, 9.11); p< 0.001] and perceived discrimination [OR 1.85 (95 % CI 1.18, 2.90); p = 0.008] remained significant barriers. Conclusions: Increased concerns about medications (related to worry, disruption, long-term effects, and medication dependence) and perceived discrimination were the most important barriers to medication adherence in this group. Interventions that reduce medication concerns have the greatest potential to improve medication adherence in low-income stroke/TIA survivors

Effect of Body Mass Index, Testosterone, and Insulin on Breast Cancer: A Mendelian Randomization Study and Investigation of Selection Bias

BACKGROUND: Female breast cancer is the most studied cancer, and the second leading cause of cancer death in women, whose aetiology is still not completely clear. The parallel increase of incident obesity and breast cancer in women worldwide raises the question of the role of adiposity, measured by body mass index (BMI), and of major anabolic hormones, such as insulin and testosterone, on breast cancer. Observational studies are open to confounding making it difficult to clearly demonstrate causal effects. Several mendelian randomization (MR) studies have shown inverse association of BMI with breast cancer. To assess selection bias in MR studies of BMI on breast cancer and to obtain less biased estimates, own and proxy reported breast cancer was used in two-sample MR studies to assess the effect of BMI, insulin, and testosterone on breast cancer for European and East Asian women. METHODS: Genetic instruments from genome-wide association studies (GWAS) of three major exposures: 1) female specific BMI (171,977 women) from the Genetic Investigation of ANthropometric Traits (GIANT) consortium, female specific testosterone (230,454 women) from the UK Biobank, 2) female specific insulin (50,404 women) from the Meta-Analyses of Glucose and Insulin-related traits Consortium (MAGIC)), and 3) liability to breast cancer (Breast Cancer Association Consortium (BCAC), 122,977/105,974 cases/controls) and UK Biobank participant reported sibling breast cancer (16,586/345,223 cases/controls) were applied to a GWAS of maternal lifespan (n=412,937) to assess the harm of these exposures on breast cancer. Then the genetic instruments for BMI, testosterone, insulin were applied to BCAC breast cancer GWAS and participant reported sibling breast cancer, as well as Biobank Japan women’s breast cancer (5,552 cases and 89,731controls). The inverse variance weighted (IVW) method was used as the main analysis. Weighted median and MR-Egger were performed as sensitivity analyses for these univariable MR. Female BMI of East Asian women (n=72,390) from Biobank Japan was used as a positive control since female specific instruments for testosterone or insulin was only available among European women but was applied to assess the effect of testosterone and insulin on breast cancer in East Asian women. Multivariable MR (MVMR) was performed to explore the mechanisms of effect. Multivariable IVW was uses as the main analysis. Multivariable MR-Egger and MR-Lasso were used as sensitivity analyses. RESULTS: Each genetically predicted standard deviation (s.d.) higher BMI was associated with -1.50 (95% confidence interval (CI): -2.30 to -0.70) years of lifespan. Liability to BCAC breast cancer was less strongly associated with lifespan (-0.53; 95% CI: -0.74 to -0.31) than UK Biobank participant reported sibling breast cancer (-1.74; 95% CI: -2.46 to -1.03). Genetically predicted BMI was inversely associated with breast cancer in BCAC compared with unaffected individuals, odds ratio (OR) 0.74 (95% CI: 0.64 to 0.84) but was unrelated to participant reported sibling breast cancer, OR 0.99 (95% CI: 0.84 to 1.13). Each s.d. of genetically predicted higher testosterone was positively associated with participant report of sibling breast cancer in the UK Biobank, odds ratio (OR)=1.09 (95% confidence interval (CI): 1.03, 1.15). In East Asians, the association of testosterone with the positive control outcome of BMI was in the expected direction 0.04 standard deviation higher BMI (95% CI: -0.004, 0.08) per s.d. testosterone. Testosterone was also positively associated with breast cancer in East Asian women (OR=1.21, 95% CI: 1.03, 1.42). Genetically predicted each s.d. higher level of fasting insulin was not associated with participant sibling breast cancer in the UK Biobank, odds ratio (OR)=1.03 (95% confidence interval (CI): 0.86, 1.21). In East Asians, the association of fasting insulin with the positive control outcome of BMI was in the expected direction 0.10 s.d. higher BMI (95% CI: -0.05, 0.25) was resulted from per s.d. higher fasting insulin. Fasting insulin was positively but not significantly associated with breast cancer in East Asian women (OR=1.51, 95% CI: 0.79, 2.87). The MVMR estimate for testosterone on UK Biobank participant reported sibling breast cancer allowing for BMI (odds ratio (OR)=1.10; 95% confidence interval (CI): 1.02 to 1.17) did not differ from the univariable MR estimate. However, the MVMR estimate for testosterone allowing for BMI (OR=1.15; 95% CI: 0.97 to 1.37) was attenuated compared to the univariable MR estimate (OR=1.21; 95% CI: 1.03 to 1.42) in East Asian women. CONCLUSION: MR studies of harmful exposures on outcomes that can cause death before recruitment are open to left truncation. Our finding using an outcome GWAS less open to left truncation suggests higher BMI is unlikely to protect against breast cancer. In the absence of definitive MR studies about the role of BMI in breast cancer, the IARC recommendation that higher BMI is a risk factor for post-menopausal breast cancer provides the best guide to policy. Testosterone in women may increase the risk of breast cancer. Whether testosterone operates by increasing estrogen, which is known to cause breast cancer, should be investigated to clarify the causal pathway. These finding may also have important implications for use of endogenous testosterone for the use of exogenous testosterone in women as a treatment for low sexual desire or for use by transgender men. There is not enough evidence to show that insulin in women plays a role in breast cancer in European or East Asian women. Future studies with stronger and larger female-specific and population-specific genetic instruments for fasting insulin, possibly with repeated measures, are needed to evaluate the effect of insulin on breast cancer risk. BMI does not seem to mediate the effect of testosterone on breast cancer in European women but may partly mediate the effect of testosterone on breast cancer in East Asian women. Larger unbiased breast cancer GWAS are needed to confirm this finding. Larger GWAS of fasting insulin or GWAS of a more comprehensive measure of insulin that provide stronger instruments are needed to investigate whether insulin mediates the effect of testosterone on breast cancer, because the current instruments are too weak

Understanding the Challenges of Adjuvant Treatment Measurement and Reporting in Breast Cancer Cancer Treatment Measuring and Reporting

Background: Healthcare accrediting organizations and insurers increasingly require reporting of clinical data, and cancer treatment is one area of enhanced scrutiny. Objectives: To compare rates of received versus reported adjuvant breast cancer treatments, and to assess barriers to measuring and reporting treatments to the tumor registry (TR) of a high-volume medical center with both hospital-based and community-based oncologists. Research Design: We calculated rates of received treatments using data collected using chart abstraction (N = 115) and compared these with rates of reported treatments from the TR (N = 535). We conducted 31 indepth interviews with clinical and administrative informants. Asking about perceptions of the TR, current reporting methods, and reporting barriers. Interviews were recorded, transcribed, and analyzed using deductive and inductive methods. Results: Rates of reported versus received treatments were radiation therapy after breast-conserving surgery 22% versus 84% (P < 0.0001); chemotherapy for stage 2 or 3: 17% versus 79% (P < 0.0001); hormonal therapy for stage 2 or 3: 1% versus 91% (P < 0.0001). Comparing community-based versus hospital-based oncologists' rates reported to the TR, we found the following differences: radiation therapy post-breast conserving surgery 12% versus 32% (< 0.0001); chemotherapy 8% versus 29% (< 0.0001); and hormonal therapy 0% versus 3% (0.09). We found 4 key barriers to measuring and reporting poor understanding about the TR, limited information technology capabilities, poor communication, and mistrust. Conclusions: Efforts to improve cancer care quality by improved treatment reporting must overcome key barriers, especially those involving information exchange and mistrust. Communications between the TR and oncology practices must improve to facilitate better treatment measurement and reporting

Clinical Study Utilization of Oncotype DX in an Inner City Population: Race or Place?

Oncotype DX, a 21-gene-array analysis, can guide chemotherapy treatment decisions for women with ER+ tumors. Of 225 ER+ women participating in a patient assistance trial, 23% underwent Oncotype DX testing: 31% of whites, 21% of blacks, and 14% of Hispanics ( = 0.04) were tested. Only 3 white women were treated at municipal hospitals and none was tested. 3% of women treated in municipal hospital as compared to 30% treated at tertiary referral centers were tested ( = 0.001). Within tertiary referral centers, there was no racial difference in testing: 32% of whites, 29% of blacks, and 19% of Hispanics ( = 0.25). Multivariate analysis (model c-statistic = 0.76; &lt; 0.0001) revealed that women who underwent testing were more likely to have stage 1B (RR = 1.70; 95% CI: 1.45-1.85) and to be treated after 2007 (RR = 1.34; 95% CI: 1.01-1.65) and less likely to be treated at a municipal hospital (RR = 0.20; 95% CI: 0.04-0.94). Women treated at municipal hospitals were less likely to undergo testing resulting in a misleading racial disparity that is driven by site of care. As Oncotype DX can reduce overuse of chemotherapy, it is imperative to expand testing to those who could benefit from yet experience underuse of this test, namely, women treated at safety net hospitals. This trial is registered with NCT00233077

Utilization of Oncotype DX in an Inner City Population: Race or Place?

Oncotype DX, a 21-gene-array analysis, can guide chemotherapy treatment decisions for women with ER+ tumors. Of 225 ER+ women participating in a patient assistance trial, 23% underwent Oncotype DX testing: 31% of whites, 21% of blacks, and 14% of Hispanics (P=0.04) were tested. Only 3 white women were treated at municipal hospitals and none was tested. 3% of women treated in municipal hospital as compared to 30% treated at tertiary referral centers were tested (P=0.001). Within tertiary referral centers, there was no racial difference in testing: 32% of whites, 29% of blacks, and 19% of Hispanics (P=0.25). Multivariate analysis (model c-statistic = 0.76; P<0.0001) revealed that women who underwent testing were more likely to have stage 1B (RR=1.70; 95% CI: 1.45–1.85) and to be treated after 2007 (RR=1.34; 95% CI: 1.01–1.65) and less likely to be treated at a municipal hospital (RR=0.20; 95% CI: 0.04–0.94). Women treated at municipal hospitals were less likely to undergo testing resulting in a misleading racial disparity that is driven by site of care. As Oncotype DX can reduce overuse of chemotherapy, it is imperative to expand testing to those who could benefit from yet experience underuse of this test, namely, women treated at safety net hospitals. This trial is registered with NCT00233077