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.
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.
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).
Low socioeconomic status and increased travel burden are barriers to care disproportionately experienced by nH Black colon cancer patients.
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.
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.
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.
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.
Abstract 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.
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
Pilot results from Malawi and Tanzania show that group prenatal care is associated with increased healthcare utilization and that a randomized controlled trial is feasible.
Abstract 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.
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.
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.
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.
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.
This study is responsive to the need for efficacious pain management for women with vulvodynia.
ClinicalTrials.gov Identifier: NCT03364127.
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.
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.
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).
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.
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.
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 PAIN
lt.
Women with GV (n = 35) compared to PVD (n = 25). Estimated mean pain sites (2.5 ± 1.4 vs 2.2 ± 1.0,
= 0.31), mean current pain (8.7 ± 1.4 vs 5.5 ± 4.0,
= 0.0008), worst pain (8.1 ± 1.8 vs 6.1 ± 3.6,
= 0.02), and least pain in the past 24 hours (4.4 ± 1.8 vs 2.0 ± 2.0,
< 0.0001). Average pain intensity (7.1 ± 1.2 vs 4.6 ± 2.9,
= 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.
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.
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