Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Prepregnancy Obesity Is Not Associated with Iron Utilization during the Third Trimester.

BACKGROUND: An adequate maternal iron supply is crucial for maternal red blood cell (RBC) expansion, placental and fetal growth, and fetal brain development. Obese women may be at risk for poor iron status in pregnancy due to proinflammatory-driven overexpression of hepcidin leading to decreased iron bioavailability. OBJECTIVE: The objective of this study was to determine the impact of prepregnancy (PP) obesity on third-trimester maternal iron utilization. DESIGN: Using the stable isotope 57Fe, we measured iron utilization in the third trimester in PP obese [BMI (in kg/m2): ≥30] and nonobese (BMI: 18.5-29.9) women. We also assessed iron status, hepcidin, inflammation, erythropoietin, dietary iron intake, and gestational weight gain. Descriptive and inferential statistical tests (e.g., Student t test, Pearson correlation) were used for data analysis. RESULTS: Fifty pregnant women (21 PP obese, 29 PP nonobese) were included. Mean age was 27.6 ± 6.8 y and mean gestational age at time of 57Fe administration was 32.7 ± 0.7 wk. Anemia (hemoglobin <11 g/dL for non-black and <10.2 g/dL for black women) affected 38% of women (43% PP obese compared with 35% PP nonobese; P = 0.55). Women with PP obesity had significantly higher C-reactive protein (8.5 compared with 3.4 mg/L, P = 0.0007) and total body iron corrected for inflammation (6.0 compared with 4.3 mg/kg, P = 0.04) compared with the nonobese women. There was no difference in serum hepcidin or iron utilization between the PP BMI groups. CONCLUSION: This is the first study to assess the impact of PP obesity on maternal iron utilization. We found no difference in iron utilization in the third trimester of pregnancy in women with and without PP obesity. Despite higher frequency of anemia, women with PP obesity had less depleted body iron stores, suggesting some degree of iron sequestration. This finding should be followed up and extended to understand effects on fetal iron bioavailability.

Physical Symptom Cluster Subgroups in Chronic Kidney Disease.

BACKGROUND: Symptom burden associated with chronic kidney disease can be debilitating, with a negative effect on patient health-related quality of life. Latent class clustering analysis is an innovative tool for classifying patient symptom experience. OBJECTIVES: The aim of the study was to identify subgroups of patients at greatest risk for high symptom burden, which may facilitate development of patient-centered symptom management interventions. METHODS: In this cross-sectional analysis, baseline data were analyzed from 3,921 adults enrolled in the Chronic Renal Insufficiency Cohort Study from 2003 to 2008. Latent class cluster modeling using 11 items on the Kidney Disease Quality of Life symptom profile was employed to identify patient subgroups based on similar observed physical symptom response patterns. Multinomial logistic regression models were estimated with demographic variables, lifestyle and clinical variables, and self-reported measures (Kidney Disease Quality of Life physical and mental component summaries and the Beck Depression Inventory). RESULTS: Three symptom-based subgroups were identified, differing in severity (low symptom, moderate symptom, and high symptom). After adjusting for other variables in multinomial logistic regression, membership in the high-symptom subgroup was less likely for non-Hispanic Blacks and men. Other factors associated with membership in the high-symptom subgroup included lower estimated glomerular filtration rate, history of cardiac/cardiovascular disease, higher Beck Depression Inventory scores, and lower Kidney Disease Quality of Life physical and mental component summaries. DISCUSSION: Three symptom subgroups of patients were identified among patients with mild-to-moderate chronic kidney disease. Several demographic and clinical variables predicted membership in subgroups. Further research is needed to determine if symptom subgroups are stable over time and can be used to predict healthcare utilization and clinical outcomes.

A Systematic Review and Meta-Analysis on the Effects of Probiotic Species on Iron Absorption and Iron Status.

BACKGROUND: Strategies to prevent iron deficiency anemia (IDA) have varying effectiveness. The purpose of this systematic review of the literature and meta-analysis was to examine the effects of probiotics on iron absorption and iron status-related markers in humans. METHODS: We followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) reporting guidelines. Relevant articles were identified from Embase, Pubmed, Scopus, and CINAHL from inception to February, 2019. We conducted a meta-analysis for eight studies examining the effect of the probiotic Lactobacillus plantarum 299v (Lp299v) on iron absorption. RESULTS: Fifteen studies reported in 12 articles were identified (N = 950). Our meta-analysis of eight studies using a random-effects model demonstrated a significant increase in iron absorption following administration of the probiotic Lp299v with a pooled standardized mean difference (an average intervention effect size) of 0.55 (95% CI 0.22-0.88, p = 0.001). Of the seven randomized clinical trials (RCTs) and nonrandomized clinical trials examining a range of probiotic species on iron status, only one study supplementing with Lp299v showed improvement in serum iron; no other studies reported improvement in iron status-related indices with probiotic treatment. CONCLUSIONS: Lp299v significantly improved iron absorption in humans. Future research should include the assessment of Lp299v effect on iron absorption and iron status in populations at high risk of IDA, including pregnant women.

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial.

BACKGROUND: Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha. OBJECTIVE: This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables. METHODS: We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life. RESULTS: This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020. CONCLUSIONS: We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14705.

Vulvodynia, "A Really Great Torturer": A Mixed Methods Pilot Study Examining Pain Experiences and Drug/Non-drug Pain Relief Strategies.

BACKGROUND: Women with vulvodynia, a chronic pain condition, experience vulvar pain and dyspareunia. Few studies examine the range and combination of treatment strategies that women are actually using to reduce vulvodynia. AIM: To describe pain experiences and pain relief strategies of women with vulvodynia. METHODS: Convenience sample, 60 women with vulvodynia (median age 32.5 [interquartile range {IQR} 8.5] years; 50 white, 10 racial/ethnic minorities) completed PAINReportIt and reported use of drugs and alcohol and responded to open-ended questions. Univariate descriptive statistics and bivariate inferential tests were used to describe average pain intensity scores, alcohol use, smoking, number of pain relief strategies, and their associations. Women's open-ended responses about their pain experiences and drug and non-drug pain relief strategies (NDPRS) were analyzed for patterns. OUTCOMES: Our mixed methods analysis connected data from pain measures, prescribed treatments and self-reported behaviors with women's free responses. This enabled nuanced insights into women's vulvodynia pain experiences. RESULTS: Women's descriptions of their pain and suffering aligned with their reported severe pain and attempts to control their pain, with a median pain intensity of 6.7 (IQR 2.0) despite use of adjuvant drugs (median 2.0 [IQR 2.0]), and opioids (median 1.0 [IQR 2.0]). 36 women (60%) used alcohol to lessen their pain. 26 women (43%) listed combining analgesics and alcohol to relieve their pain. 30 women (50%) smoked cigarettes. 54 women (90%) used ≥1 NDPRS. The mean number of NDPRS used was 2.1 ± 1.3 (range 0-6). The 5 most common NDPRS from women's comments were herbal medicine (40%), acupuncture (27%), massage (22%), hypnosis (15%), and mental healthcare (13%). CLINICAL IMPLICATIONS: Severe pain in women with vulvodynia may be a clinical indicator of those at higher risk of combining prescription pain medications with alcohol, which are all central nervous system depressants and may potentiate overdose. STRENGTHS AND LIMITATIONS: This pilot study demonstrated that the mixed methods approach to help understand the complexity of vulvodynia was feasible. We identified data showing a reliance on a high-risk mix of prescriptions and alcohol to reduce vulvodynia pain and a high prevalence of cigarette smoking. However, as a pilot study, these results are considered preliminary; the sample may not be representative. Perhaps only women at the extreme end of the pain continuum participated, or women took the survey twice because identifiers were not collected. CONCLUSION: Despite attempts to reduce pain using multiple therapies, including alcohol, women's vulvodynia pain is severe and not controlled. Schlaeger JM, Pauls HA, Powell-Roach KL, et al. Vulvodynia, "A Really Great Torturer": A Mixed Methods Pilot Study Examining Pain Experiences and Drug/Non-drug Pain Relief Strategies. J Sex Med 2019;16:1255-1263.

Sensory pain characteristics of vulvodynia and their association with nociceptive and neuropathic pain: an online survey pilot study.

OBJECTIVES: To evaluate self-reported sensory pain scores of women with generalized vulvodynia (GV) and provoked vestibulodynia (PVD), characterize pain phenotypes, and assess feasibility of using the Internet for recruitment and data collection among women with vulvodynia. METHODS: Descriptive online survey. Data collected using an online survey accessed via a link on the National Vulvodynia Association web site. Convenience sample, 60 women aged 18 to 45 years (mean = 32.7 ± 5.5); 50 white, 2 black/African American, 4 Hispanic/Latino, and 4 Native American/Alaskan Native, diagnosed with vulvodynia, not in menopause. Pain assessment and medication modules from PAINReportlt. RESULTS: Women with GV (n = 35) compared to PVD (n = 25). Estimated mean pain sites (2.5 ± 1.4 vs 2.2 ± 1.0, P = 0.31), mean current pain (8.7 ± 1.4 vs 5.5 ± 4.0, P = 0.0008), worst pain (8.1 ± 1.8 vs 6.1 ± 3.6, P = 0.02), and least pain in the past 24 hours (4.4 ± 1.8 vs 2.0 ± 2.0, P < 0.0001). Average pain intensity (7.1 ± 1.2 vs 4.6 ± 2.9, P = 0.0003) on a scale of 0 to 10, mean number of neuropathic words (8.3 ± 3.6 vs 7.7 ± 5.0), and mean number of nociceptive words (6.9 ± 4 vs 7.5 ± 4.4). Nineteen (54%) women with GV compared to 9 (38%) with PVD were not satisfied with pain levels. CONCLUSION: Women with GV reported severe pain, whereas those with PVD reported moderate to severe pain. Pain quality descriptors may aid a clinician's decisions about whether to prescribe adjuvant drugs vs opioids to women with vulvodynia.

Estimating Maternal Mortality in Remote Rural Regions: an Application of the Sisterhood Method in Tajikistan.

INTRODUCTION: The sisterhood method of maternal mortality data collection and analysis provides a validated framework for estimating maternal mortality ratios in situations of limited infrastructure. The aim of this study is to assess sub-national maternal mortality in the Badakhshan region of Tajikistan using the sisterhood method as part of a larger ethnographic study on maternal risk. METHODS: In 2006-2007, 1004 married women of reproductive age in Gorno-Badakhshan Autonomous Oblast, Tajikistan were surveyed using the sisterhood method. Respondents were asked eleven questions about the sex, age and survivorship of all children born to the respondent's mother. RESULTS: Using a national total fertility rate (TFR) estimate of 4.88, the maternal mortality ratio (MMR) in Tajik Badakhshan was 141 maternal deaths per 100,000 live births (95% CI 49-235). The lifetime risk of maternal death was 1 in 141 (95% CI 34-103). CONCLUSION: Given the inherent time-lag of the sisterhood method, precise estimates of maternal mortality are dependent on accurate TFRs, which may vary based upon regional experiences of demographic transitions. Socio-political instability and the dismantling of Soviet welfare programs and civil war following Tajikistan's independence from the Soviet Union in 1991 likely impacted TFR in Tajik Badakhshan. Socio-political trends influencing TFR in rural regions compared to urban, and the investigation of factors associated with maternal mortality, require additional investigation.

Racial Disparities in Breast Cancer Survival: The Mediating Effects of Macro-Social Context and Social Network Factors.

This study attempts to clarify the associations between macro-social and social network factors and the continuing racial disparities in breast cancer survival. The study improves on prior methodologies by using a neighborhood disadvantage measure that assesses both economic and social disadvantage and an ego-network measurement tool that assesses key social network characteristics. Our population-based sample included 786 breast cancer patients (nHWhite=388; nHBlack=398) diagnosed during 2005-2008 in Chicago, IL. The data included census-derived macro-social context, self-reported social network, self-reported demographic and medically abstracted health measures. Mortality data from the National Death Index (NDI) were used to determine 5-year survival. Based on our findings, neighborhood concentrated disadvantage was negatively associated with survival among nHBlack and nHWhite breast cancer patients. In unadjusted models, social network size, network density, practical support, and financial support were positively associated with 5-year survival. However, in adjusted models only practical support was associated with 5-year survival. Our findings suggested that the association between network size and breast cancer survival is sensitive to scaling of the network measure, which helps to explain inconsistencies in past findings. Social networks of nHWhites and nHBlacks differed in size, social support dimensions, network density, and geographic proximity. Among social factors, residence in disadvantaged neighborhoods and unmet practical support explained some of the racial disparity in survival. Differences in late stage diagnosis and comorbidities between nHWhites and nHBlacks also explained some of the racial disparity in survival. Our findings highlight the relevance of social factors, both macro and inter-personal in the racial disparity in breast cancer survival. Findings suggest that reduced survival of nHBlack women is in part due to low social network resources and residence in socially and economically deprived neighborhoods. To improve survival among breast cancer patients social policies need to continue improving health care access as well as racially patterned social and economic disadvantage.

If you build it, they may not come: modifiable barriers to patient portal use among pre- and post-kidney transplant patients.

BACKGROUND: Patient access to health information using electronic patient portals is increasingly common. Portal use has the potential to improve patients' engagement with their health and is particularly important for patients with chronic illness; however, patients' abilities, attitudes, and use of portals are poorly understood. METHODS: A single-center, cross-sectional survey was conducted of 240 consecutive pre- and post-kidney transplant patients of all levels of technological proficiency who presented to an urban transplant center in the United States. The investigator-developed Patient Information and Technology Assessment-Patient Portal was used to assess patients' attitudes towards the use of patient portals. RESULTS: Most patients surveyed did not use the patient portal (n = 176, 73%). Patients were more likely to use the patient portal if they were White, highly educated, in the post-transplant period, more comfortable with technology, and reported being a frequent internet user (P < .05). The most common reasons for not using the patient portal included: (1) preference for traditional communication, (2) not being aware of the portal, (3) low technological proficiency, and (4) poor interoperability between the portal at the transplant center and the patient's primary care center. CONCLUSIONS: We identified several modifiable barriers to patient portal use. Some barriers can be addressed by patient education and training on portal use, and federal initiatives are underway to improve interoperability; however, a preference for traditional communications represents the most prominent barrier. Additional strategies are needed to improve portal adoption by encouraging acceptance of technologies as a way of clinical communication.

Patient Navigation Improves Subsequent Breast Cancer Screening After a Noncancerous Result: Evidence from the Patient Navigation in Medically Underserved Areas Study.

BACKGROUND: Past efforts to assess patient navigation on cancer screening utilization have focused on one-time uptake, which may not be sufficient in the long term. This is partially due to limited resources for in-person, longitudinal patient navigation. We examine the effectiveness of a low-intensity phone- and mail-based navigation on multiple screening episodes with a focus on screening uptake after receiving noncancerous results during a previous screening episode. METHODS: The is a secondary analysis of patients who participated in a randomized controlled patient navigation trial in Chicago. Participants include women referred for a screening mammogram, aged 50-74 years, and with a history of benign/normal screening results. Navigation services focused on identification of barriers and intervention via shared decision-making processes. A multivariable logistic regression intent-to-treat model was used to examine differences in odds of obtaining a screening mammogram within 2 years of the initial mammogram (yes/no) between navigated and non-navigated women. Sensitivity analyses were conducted to explore patterns across subsets of participants (e.g., navigated women successfully contacted before the initial appointment; women receiving care at Hospital C). RESULTS: The final sample included 2,536 women (741 navigated, 1,795 non-navigated). Navigated women exhibited greater odds of obtaining subsequent screenings relative to women in the standard care group in adjusted models and analyses including women who received navigation before the initial appointment. CONCLUSIONS: Our findings suggest that low-intensity navigation services can improve follow-up screening among women who receive a noncancerous result. Further investigation is needed to confirm navigation's impacts on longitudinal screening.

Examining racial disparities in colon cancer clinical delay in the Colon Cancer Patterns of Care in Chicago study.

PURPOSE: We explored a potential racial disparity in clinical delay among non-Hispanic (nH) Black and White colon cancer patients and examined factors that might account for the observed disparity. METHODS: Patients aged 30-79 years with a newly diagnosed colon cancer from 2010 to 2014 (n = 386) were recruited from a diverse sample of nine public, private, and academic hospitals in and around Chicago. Prolonged clinical delay was defined as 60 days or more or 90 days or more between medical presentation (symptoms or a screen-detected lesion) and treatment initiation (surgery or chemotherapy). Multivariable logistic regression with model-based standardization was used to estimate the disparity as a difference in prevalence of prolonged delay by race. RESULTS: Prevalence of delay in excess of 60 days was 12 percentage points (95% confidence interval: 2%, 22%) higher among nH Blacks versus Whites after adjusting for age, facility, and county of residence. Travel burden (time and distance traveled from residence to facility) explained roughly one-third of the disparity (33%, P = .05), individual and area-level socioeconomic status measures explained roughly one-half (51%, P = .21), and socioeconomic measures together with travel burden explained roughly four-fifths (79%, P = .08). CONCLUSIONS: Low socioeconomic status and increased travel burden are barriers to care disproportionately experienced by nH Black colon cancer patients.

Randomized controlled pilot of a group antenatal care model and the sociodemographic factors associated with pregnancy-related empowerment in sub-Saharan Africa.

BACKGROUND: The links between empowerment and a number of health-related outcomes in sub-Saharan Africa have been documented, but empowerment related to pregnancy is under-investigated. Antenatal care (ANC) is the entry point into the healthcare system for most women, so it is important to understand how ANC affects aspects of women's sense of control over their pregnancy. We compare pregnancy-related empowerment for women randomly assigned to the standard of care versus CenteringPregnancy-based group ANC (intervention) in two sub-Saharan countries, Malawi and Tanzania. METHODS: Pregnant women in Malawi (n = 112) and Tanzania (n = 110) were recruited into a pilot study and randomized to individual ANC or group ANC. Retention at late pregnancy was 81% in Malawi and 95% in Tanzania. In both countries, individual ANC, termed focused antenatal care (FANC), is the standard of care. FANC recommends four ANC visits plus a 6-week post-birth visit and is implemented following the country's standard of care. In group ANC, each contact included self- and midwife-assessments in group space and 90 minutes of interactive health promotion. The number of contacts was the same for both study conditions. We measured pregnancy-related empowerment in late pregnancy using the Pregnancy-Related Empowerment Scale (PRES). Independent samples t-tests and multiple linear regressions were employed to assess whether group ANC led to higher PRES scores than individual ANC and to investigate other sociodemographic factors related to pregnancy-related empowerment. RESULTS: In Malawi, women in group ANC had higher PRES scores than those in individual ANC. Type of care was a significant predictor of PRES and explained 67% of the variation. This was not so in Tanzania; PRES scores were similar for both types of care. Predictive models including sociodemographic variables showed religion as a potential moderator of treatment effect in Tanzania. Muslim women in group ANC had a higher mean PRES score than those in individual ANC; a difference not observed among Christian women. CONCLUSIONS: Group ANC empowers pregnant women in some contexts. More research is needed to identify the ways that models of ANC can affect pregnancy-related empowerment in addition to perinatal outcomes globally.

Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

OBJECTIVE: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS: The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION: Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.

Physician Decisions to Defer Antiretroviral Therapy in Key Populations: Implications for Reducing Human Immunodeficiency Virus Incidence and Mortality in Malaysia.

BACKGROUND: Antiretroviral therapy (ART) is recommended for all people living with human immunodeficiency virus (HIV), yet physician attitudes and prescribing behaviors toward members of key risk populations may limit ART access and undermine treatment as prevention strategies. METHODS: Physicians in Malaysia (N = 214) who prescribe antiretroviral therapy (ART) responded in an Internet-based survey to hypothetical clinical scenarios of HIV patients, varying by key risk population and CD4+ T-cell count, on whether they would initiate or defer ART compared with a control patient with sexually acquired HIV. RESULTS: The proportion of physicians who would defer ART in patients with advanced HIV (CD4 = 17 cells/µL) was significantly higher (P < .0001) for 4 key populations, including people who inject drugs ([PWID] 45.3%) or consume alcohol (42.1%), released prisoners (35.0%), and those lacking social support (26.6%), compared with a control patient (4.2%). People who inject drugs with advanced HIV (CD4 = 17 cells/µL) were 19-fold (adjusted odds ratio [AOR] = 18.9; 95% confidence interval [CI], 9.8-36.5) more likely to have ART deferred compared with the control. This effect was partially mitigated for PWID receiving methadone (AOR = 2.9; 95% CI, 1.5-5.7). At the highest CD4+ T-cell count (CD4 = 470 cells/µL), sex workers (AOR = 0.55; 95% CI, .44-.70) and patients with an HIV-uninfected sexual partner (AOR = 0.43; 95% CI, .34-.57) were significantly less likely to have ART deferred. CONCLUSIONS: Physicians who prescribe antiretroviral therapy in Malaysia may defer ART in some key populations including PWID and released prisoners, regardless of CD4+ T-cell count, which may help to explain very low rates of ART coverage among PWID in Malaysia. Reducing HIV incidence and mortality in Malaysia, where HIV is concentrated in PWID and other key populations, requires clinician-level interventions and monitoring physician adherence to international evidence-based treatment guidelines.

Racial disparity in survival from estrogen and progesterone receptor-positive breast cancer: implications for reducing breast cancer mortality disparities.

INTRODUCTION: Non-Latina black breast cancer patients experience a shorter survival from breast cancer than their non-Latina white counterparts. We compared breast cancer-specific survival for the subset of black and white patients with estrogen and/or progesterone receptor-positive tumors that are generally targeted with endocrine therapy. METHODS: Using data collected from a population-based cohort of breast cancer patients from Chicago, IL, Kaplan-Meier survival curves and hazard functions were generated and proportional hazards models were estimated to determine the black/white disparity in time to death from breast cancer while adjusting for age at diagnosis, patient characteristics, treatment-related variables, and tumor grade and stage. RESULTS: In regression models, hazard of breast cancer death among ER/PR-positive patients was at least 4 times higher for black than for white patients in all models tested. Notably, even after adjusting for stage at diagnosis, tumor grade, and treatment variables (including initiation of systemic adjuvant therapies), the hazard ratio for death from ER/PR-positive breast cancer between black and white women was 4.39 (95% CI 1.76, 10.9, p = 0.001). CONCLUSIONS: We observed a racial disparity in breast cancer survival for patients diagnosed with ER/PR-positive tumors that did not appear to be due to differences in tumor stage, grade, or therapy initiation in black patients, suggesting that there may be racial differences in the molecular characteristics of hormone receptor-positive tumors, such that ER/PR-positive tumors in black patients may be less responsive to standard treatments.

Patient Navigation in Medically Underserved Areas study design: A trial with implications for efficacy, effect modification, and full continuum assessment.

BACKGROUND: The Patient Navigation in Medically Underserved Areas study objectives are to assess if navigation improves: 1) care uptake and time to diagnosis; and 2) outcomes depending on patients' residential medically underserved area (MUA) status. Secondary objectives include the efficacy of navigation across 1) different points of the care continuum among patients diagnosed with breast cancer; and 2) multiple regular screening episodes among patients who did not obtain breast cancer diagnoses. DESIGN/METHODS: Our randomized controlled trial was implemented in three community hospitals in South Chicago. Eligible participants were: 1) female, 2) 18+years old, 3) not pregnant, 4) referred from a primary care provider for a screening or diagnostic mammogram based on an abnormal clinical breast exam. Participants were randomized to 1) control care or 2) receive longitudinal navigation, through treatment if diagnosed with cancer or across multiple years if asymptomatic, by a lay health worker. Participants' residential areas were identified as: 1) established MUA (before 1998), 2) new MUA (after 1998), 3) eligible/but not designated as MUA, and 4) affluent/ineligible for MUA. Primary outcomes include days to initially recommended care after randomization and days to diagnosis for women with abnormal results. Secondary outcomes concern days to treatment initiation following a diagnosis and receipt of subsequent screening following normal/benign results. DISCUSSION: This intervention aims to assess the efficacy of patient navigation on breast cancer care uptake across the continuum. If effective, the program may improve rates of early cancer detection and breast cancer morbidity.

The influence of neighborhood socioeconomic status and race on survival from ovarian cancer: a population-based analysis of Cook County, Illinois.

PURPOSE: Despite significant improvements in treatment for ovarian cancer, survival is poorer for non-Hispanic black (NHB) women compared to non-Hispanic white (NHW) women. Neighborhood socioeconomic status (SES) has been implicated in racial disparities across a variety of health outcomes and may similarly contribute to racial disparities in ovarian cancer survival. The purpose of this analysis is to assess the influence of neighborhood SES on NHB-NHW survival differences after accounting for differences in tumor characteristics and in treatment. METHODS: Data were obtained from 2432 women (443 NHB and 1989 NHW) diagnosed with epithelial ovarian cancer in Cook County, Illinois between 1998 and 2007. Neighborhood (i.e., census tract) SES at the time of diagnosis was calculated for each woman using two well-established composite measures of affluence and disadvantage. Cox proportional hazard models measured the association between NHB race and survival after adjusting for age, tumor characteristics, treatment, year of diagnosis, and neighborhood SES. RESULTS: There was a strong association between ovarian cancer survival and both measures of neighborhood SES (P < .0001 for both affluence and disadvantage). After adjusting for age, tumor characteristics, treatment, and year of diagnosis, NHB were more likely than NHW to die of ovarian cancer (hazard ratio [HR] = 1.47, 95% confidence interval [CI]: 1.28-1.68). The inclusion of neighborhood affluence and disadvantage into models separately and together attenuated this risk (HRaffluence = 1.37, 95% CI: 1.18-1.58; HRdisadvantage = 1.28, 95% CI: 1.08-1.52; and HRaffluence + disadvantage = 1.28, 95% CI: 1.08-1.52. CONCLUSIONS: Neighborhood SES, as measured by composite measures of affluence and disadvantage, is a predictor of survival in women diagnosed with ovarian cancer in Cook County, Illinois and may contribute to the racial disparity in survival.

The effect of neighborhood-level socioeconomic status on racial differences in ovarian cancer treatment in a population-based analysis in Chicago.

BACKGROUND: Less than half of women with ovarian cancer and blacks specifically receive therapy adherent to National Comprehensive Cancer Network (NCCN) guidelines. The purpose is to assess the effect of neighborhood-level socioeconomic status (SES) on black-white treatment differences in a population-based analysis in a highly-segregated community. METHODS: Illinois State Cancer Registry data for invasive epithelial ovarian cancer cases diagnosed in Cook County, IL in non-Hispanic white (NHW) or black (NHB) women from 1998 to 2009 was analyzed. As few women receive NCCN-adherent care, variables were constructed to assess extent of treatment, including receipt of: 1) debulking surgery; 2) any surgery; 3) multi-agent chemotherapy; and 4) any chemotherapy. Two measures (concentrated affluence and disadvantage) were used to estimate neighborhood-level SES. Multivariable logistic regression was used to compute odds ratios (OR) and 95% confidence intervals (95% CI), with generalized linear mixed models to account for hierarchical data. RESULTS: 2766 (81.0%) NHW and 647 (19.0%) NHB women were diagnosed. Adjusting for covariates, NHB were less likely to receive debulking surgery (OR: 0.39; 95% CI: 0.30-0.50), any surgery (OR: 0.38; 95%CI: 0.29-0.49), multi-agent chemotherapy (OR: 0.56; 95% CI: 0.45-0.71) and any chemotherapy (OR: 0.58; 95% CI: 0.45-0.74). Concentrated affluence but not disadvantage was significant in final models for multi-agent and any chemotherapy, but not debulking or any surgery. CONCLUSIONS: Results identify black-white differences consistent across treatments that persist despite adjustment for neighborhood-level SES. IMPACT: Results advance inequality awareness beyond "ideal" NCCN-adherent care, indicating inequality exists in delivery of even the most basic oncologic care.