Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.

OBJECTIVE: To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy. METHODS: This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined. RESULTS: From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59). CONCLUSION: Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation. CLINICAL TRIAL REGISTRATION: ClinialTrials.gov, NCT01990612.

Drinking, Social Abstaining, and Refusing Invitations: Demographic Differences Persist Across College.

BACKGROUND: Alcohol use and misuse are prevalent on many college campuses. The current study examined participation in college environments where alcohol is present and being consumed. We documented students' alcohol consumption, social abstaining (i.e., attending an alcohol-present event, but not drinking), and refusing invitations to drinking events. We tested for differences by parental education, immigrant status, race-ethnicity, and gender. We charted longitudinal change across college. METHODS: First-year students attending a large public US university (n = 681, 18% first-generation college student, 16% first-generation immigrant, 73% racial-ethnic minority group member, 51% women) were recruited and followed longitudinally for 7 semesters. Each semester, students completed up to 14 daily surveys; responses were aggregated to the semester level (n = 4,267). RESULTS: Multilevel logistic regression models demonstrated that first-generation college students were less likely to drink and refuse invitations to drinking events than students with a college-educated parent (Adjusted Odds Ratios [AORs]: 0.66, 0.72, respectively). Similarly, first-generation immigrants were less likely to drink, socially abstain, and refuse invitations (AORs: 0.58 to 0.73). Compared with White students, Black and Asian American students were less likely to drink (AORs: 0.55, 0.53) and refuse invitations to drinking events (AORs: 0.68, 0.66). The proportion of days spent drinking increased across college, and refusing invitations was the most common at the start and end of college. CONCLUSIONS: First-generation college students, first-generation immigrant students, and Black and Asian students participated less in prodrinking environments during college. These findings indicate that on drinking and nondrinking days, students' participation in alcohol-present situations differed by background. Furthermore, our results indicate that the students who are most likely to refuse invitations to drinking events are the same students who drink most frequently.

[Poliomyelitis--Challenges for the Last Mile of the Eradication Programme]. / Poliomyelitis--Herausforderungen in der Endphase des globalen Eradikationsprogramms.

The World Health Organisation initiated the Global Polio Eradication Initiative in the year 1988. With the large-scale application of routine and mass vaccinations in children under the age of 5 years, polio disease has become restricted to only 3 endemic countries (Afghanistan, Pakistan and Nigeria) by today. However, since the beginning of the 21st century, increasing numbers of secondary polio epidemics have been observed which were triggered through migration, political turmoil and weak health systems. In addition, there emerged serious technical (e. g., back-mutations of oral vaccine virus to wild virus) and socio-political (refusal of vaccinations in Muslim populations of Nigeria and Pakistan) problems with the vaccination in the remaining endemic countries. It thus appears questionable if the current eradiation initiative will reach its goal in the foreseeable future.

Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria.

BACKGROUND: Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups. METHODS: Surveys were administered in face-to-face interviews with 215 participants following their enrollment in the genetic study (106 patients, 109 controls). Audio-taped in-depth interviews were conducted with a sub-sample of 17 (8%) women who completed the survey. RESULTS: The majority of all participants reported being told that participation in the genetic study was voluntary (97%), that they did not feel pressured to participate in the study (99%), and that they could withdraw from the study (81%). The majority of the breast cancer patients (83%) compared to 58% of women in the control group reported that the study purpose was to learn about the genetic inheritance of breast cancer (OR 3.44; 95% CI =1.66, 7.14, p value = 0.001). Most participants reported being told about study procedures (95%) and study benefits (98%). Sixty-eight percent of the patients, compared to 47% of the control group reported being told about study risks (p-value <0.001). Of the 165 married women, 19% reported asking permission from their husbands to enroll in the breast cancer study; no one sought permission from local elders. In-depth interviews highlight the use of persuasion and negotiation between a wife and her husband regarding study participation. CONCLUSIONS: The global expansion of genetic and genomic research highlights our need to understand informed consent practices for studies in ethnically diverse cultural environments such as Africa. Quantitative and qualitative empirical investigations of the informed consent process for genetic and genomic research will further our knowledge of complex issues associated with communication of information, comprehension, decisional authority and voluntary participation. In the future, the development and testing of innovative strategies to promote voluntary participation and comprehension of the goals of genomic research will contribute to our understanding of strategies that enhance the consent process.

Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial.

The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60 to 95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels.

Attitudes and barriers towards participation in an acupuncture trial among breast cancer patients: a survey study.

BACKGROUND: As breast cancer patients increasingly use complementary and alternative medicine (CAM), clinical trials are needed to guide appropriate clinical use. We sought to identify socio-demographic, clinical and psychological factors related to willingness to participate (WTP) and to determine barriers to participation in an acupuncture clinical trial among breast cancer patients. METHODS: We conducted a cross-sectional survey study among post-menopausal women with stage I-III breast cancer on aromatase inhibitors at an urban academic cancer center. RESULTS: Of the 300 participants (92% response rate), 148 (49.8%) reported WTP in an acupuncture clinical trial. Higher education (p = 0.001), increased acupuncture expectancy (p < 0.001), and previous radiation therapy (p = 0.004) were significantly associated with WTP. Travel difficulty (p = 0.002), concern with experimentation (p = 0.013), and lack of interest in acupuncture (p < 0.001) were significant barriers to WTP. Barriers differed significantly by socio-demographic factors with white people more likely to endorse travel difficulty (p = 0.018) and non-white people more likely to report concern with experimentation (p = 0.024). Older patients and those with lower education were more likely to report concern with experimentation and lack of interest in acupuncture (p < 0.05). CONCLUSIONS: Although nearly half of the respondents reported WTP, significant barriers to participation exist and differ among subgroups. Research addressing these barriers is needed to ensure effective accrual and improve the representation of individuals from diverse backgrounds.

Rate and predictors of service disengagement among patients with first-episode psychosis.

OBJECTIVE: This study determined the rate of service disengagement among patients in the Early Psychosis Intervention Program (EPIP) in Singapore and predictors of disengagement. METHODS: EPIP is a two-year multidisciplinary program targeting first-episode psychosis. The sample comprised patients consecutively accepted (2001-2009) who had two years of follow-up data. Disengagement was assessed with a semistructured scale. Sociodemographic and clinical variables were assessed with the Structured Clinical Interview for DSM-IV Axis I Disorders, the Positive and Negative Syndrome Scale, and the Global Assessment of Functioning. Regression analyses were conducted. RESULTS: Among 775 patients, 109 (14%) disengaged from EPIP within two years. Significant baseline predictors included Malay ethnicity (odds ratio [OR]=1.93, 95% confidence interval [CI]=1.12-3.29) and less than six years of education (OR=2.30, CI=1.23-4.29). CONCLUSIONS: EPIP's engagement strategy should focus on patients of Malay ethnicity and of low educational attainment. Further studies should examine how these factors affect service disengagement.

Recruitment of pregnant women in research.

The aim was to identify factors that could influence recruitment in a prospective longitudinal study involving pregnant women. A total of 269 nulliparous women were enrolled for a prospective longitudinal study, to establish the prevalence of levator ani muscle defects during childbirth. The project was explained verbally and potential participants were given an information leaflet. When eligible and interested, they provided their contact details to enquire if they were willing to participate. Out of the 1,473 women approached, 269 (18.3%) agreed to participate and 1,043 (70.8%) declined; 420 women (40.3%) did not provide a reason for non-participation (see text for further details). Most often mentioned reasons were 'being too busy', 'other pregnancy problems', 'no additional (internal) examination', 'moving (abroad)' and 'husband'. Women from different ethnicities and age groups gave a wide variety of reasons for non-participation. This information can now be used by researchers recruiting women for comparable studies, to enhance recruitment and participation of eligible patients.

Missed opportunities: refusal to confirm reactive rapid HIV tests in the emergency department.

BACKGROUND: HIV infection remains a major US public health concern. While HIV-infected individuals now benefit from earlier diagnosis and improved treatment options, progress is tempered by large numbers of newly diagnosed patients who are lost to follow-up prior to disease confirmation and linkage to care. METHODOLOGY: In the randomized, controlled USHER trial, we offered rapid HIV tests to patients presenting to a Boston, MA emergency department. Separate written informed consent was required for confirmatory testing. In a secondary analysis, we compared participants with reactive results who did and did not complete confirmatory testing to identify factors associated with refusal to complete the confirmation protocol. PRINCIPAL FINDINGS: Thirteen of 62 (21.0%, 95% CI (11.7%, 33.2%)) participants with reactive rapid HIV tests refused confirmation; women, younger participants, African Americans, and those with fewer HIV risks, with lower income, and without primary care doctors were more likely to refuse. We projected that up to four true HIV cases were lost at the confirmation stage. CONCLUSIONS: These findings underscore the need to better understand the factors associated with refusal to confirm reactive HIV testing and to identify interventions that will facilitate confirmatory testing and linkage to care among these populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT00502944; NCT01258582.

Under-representation of minority ethnic groups in cardiovascular research: a semi-structured interview study.

BACKGROUND: Minority ethnic groups are often excluded from research, and the reasons for this are complex. OBJECTIVE: This study aimed to explore why minority ethnic groups do not participate in research, and how their participation can be increased. METHODS: Ninety-one interviews were undertaken with people who either had (n = 48) or had not (n = 43) responded to the invitation to take part in a community heart failure screening study. These were split across four ethnic groups (African Caribbean, Bangladeshi, Indian and Pakistani) and between men and women. Participants were interviewed once, face-to-face, either in English or with an interpreter if they wished. Interview transcripts were analysed thematically. RESULTS: The main reason for participating in the screening study was for a health/heart check. Many participants either had not understood that it was research or had not known what this meant. Most people who did not participate had not remembered receiving the invitation or had been unavailable at the time. Few participants, including those who had and those who had not participated in the screening study, had any understanding of the objectives and nature of research. Once this had been briefly explained to them, many described altruistic reasons for why they would participate in research in the future. CONCLUSIONS: We have shown that South Asians and Black African-Caribbean communities are willing to take part in research as long as they are approached directly and the reasons for the research and potential benefits are explained clearly to them.

Barriers to therapeutic clinical trials enrollment: differences between African-American and white cancer patients identified at the time of eligibility assessment.

BACKGROUND: Clinical trials (CTs) are the mechanism by which research is translated into standards of care. Low recruitment among underserved and minority populations may result in inequity in access to the latest technology and treatments, compromise the generalizability, and lead to failure in identification of important positive or negative treatment effects among under-represented populations. METHODS: Data were collected over a 39-month period on patient eligibility for available therapeutic cancer CTs. Reasons for ineligibility and refusal were collected. The data were captured using an automated software tool for tracking eligibility pre-enrollment. We examined characteristics associated with being evaluated for a trial, and reasons for ineligibility and refusal, overall and by patient race. RESULTS: African-Americans (AAs) were more likely than Whites to be ineligible (odds ratio, (OR) = 1.26, 95% confidence interval (CI) = 1.0-1.58) and if eligible, to refuse participation (OR = 1.79, 95% CI = 1.27-2.52), even after adjusting for insurance, age, gender, study phase, and cancer type. White patients were more likely to be ineligible due to study-specific or cancer characteristics. AAs were more likely to be ineligible due to mental status or perceived noncompliance. Whites were more likely to refuse due to extra burden, due to concerns with randomization and toxicity, or because they express a positive treatment preference. AAs were more likely to refuse because they were not interested in CTs, because of family pressures, or they felt overwhelmed (NS)). DISCUSSION: This study is the first to directly compare ineligibility and refusal rates and reasons captured prospectively in AA and White cancer patients. The data are consistent with earlier studies that indicated that AA patients more often are deemed ineligible and, when eligible, more often refuse participation. However, differences in reasons for ineligibility and refusal by race have implications for a cancer center to participate in CTs appropriate for the population of patients served. On a broader scale, consideration should be given to modifying eligibility criteria and other design aspects to permit broader participation of minority and other underserved groups.

Organized ambivalence: when sickle cell disease and stem cell research converge.

OBJECTIVE: This article analyzes sickle cell patient families' responses to stem cell transplant recruitment efforts. It identifies key dynamics that explain why sickle cell patient families are not undergoing stem cell transplants at the rate of other patient populations. It challenges the conventional focus on 'African-American distrust' as a set of attitudes grounded in collective memories of past abuses and projected on to current initiatives, by examining the sociality of distrust produced daily in the clinic and reinforced in broader politics of health investment. DESIGN: It draws upon a two-year multi-sited ethnography of a US-based stem cell research and cures initiative. Fieldwork included participant observation in a state stem cell agency, a publicly-funded stem cell transplant program, a sickle cell clinic, and semi-structured, open-ended interviews with caregivers and stem cell research stakeholders, all of which were subject to qualitative analysis. FINDINGS AND IMPLICATIONS: This paper finds ambivalence-in-action structured by three contextual strands: therapeutic uncertainties of the clinic, institutionalized conflation of healthcare and medical research, and political contests over scientific and medical investments. The paper posits that organized ambivalence is an analytic alternative to individualized notions of distrust and as a framework for implementing more participatory research initiatives that better account for the multiple uncertainties characteristic of regenerative medicine.

Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials.

Persons living with HIV/AIDS (PLHA) of color are under-represented in AIDS clinical trials (ACTs), which may limit the generalizability of research findings and denies many individuals access to high levels of care and new treatments available through ACTs. Disproportionately low rates of recruitment in health care settings and by providers are a major barrier to ACTs for this group. Moreover, PLHA of color are more likely than their white peers to decline to participate, mainly due to fear and mistrust (although willingness is also high), negative social norms about ACTs, and difficulty navigating the unfamiliar ACT system. We describe a small number of successful behavioral and structural interventions to increase the participation of PLHA of color in screening for and enrollment into ACTs. HIV care settings, clinical trials sites, and trial sponsors are uniquely positioned to develop procedures, supports, and trials to increase the proportion of PLHA of color in ACTs.

Assessing non-response bias in pediatric palliative care research.

National experts have recognized a need for increased research in pediatric palliative care. However, when conducting research it is important to use rigorous methods, report significant and non-significant findings, and include information on responders and non-responders. Most studies do not present information on non-responders, yet this is critical as the results many not be generalizable if there are inherent differences between the two groups. Using survey data from parents whose children with life-limiting illnesses were enrolled in Florida's publicly funded pediatric palliative care program called Partners in Care: Together for Kids; this study investigates whether non-response bias exists, and if so, what characteristics are associated with non-response. Bivariate and multivariate analyses were conducted to determine whether individual characteristics differed between responders and non-responders. Throughout our analyses, we conducted the analyses using different ways in which 'non-response' can be defined. Our results suggest that regardless of how non-response is defined, Black, non-Hispanic parents were less likely to participate than White non-Hispanic parents. However, we also found that of the Black, non-Hispanic parents who did not participate, their primary reason for doing so was that they had non-working or disconnected phone numbers. Only 3% of the Black, non-Hispanic parents who did not participate flatly refused. Information from this study can be used to design interventions aimed at increasing minority participation in pediatric palliative care research.

Asian women are less likely to express interest in infertility research.

OBJECTIVES: To assess the differences among racial and ethnic groups in their willingness to participate in medical infertility research. We further explored these differences within racial and ethnic subcategories to gain a broader understanding of minority patients' willingness to participate in infertility research. DESIGN: Cross-sectional study. SETTING: University fertility center. PATIENT(S): One thousand forty-nine women presenting for reproductive care. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Willingness to be contacted for recruitment to ongoing research. RESULT(S): Asians were less likely than non-Hispanic Whites to express willingness to be contacted regarding research (odds ratio 0.44, 95% confidence interval 0.33; 0.57), as were Middle Eastern women. Decreased willingness was seen in all Asian subcategories except Vietnamese. Women born outside the United States were less likely to consent to be contacted than those born in the United States. CONCLUSION(S): Asian and Middle Eastern patients are less likely than non-Hispanic Whites to express interest in research participation in the infertility clinic setting. Strategies to target these women for research recruitment are necessary to achieve parity in both research participation and assisted reproductive technology outcomes.

Why don't out-of-treatment individuals enter methadone treatment programmes?

BACKGROUND: Despite the proven effectiveness of methadone treatment, the majority of heroin-dependent individuals are out-of-treatment. METHODS: Twenty-six opioid-dependent adults who met the criteria for methadone maintenance who were neither seeking methadone treatment at the time of study enrollment, nor had participated in such treatment during the past 12 months, were recruited from the streets of Baltimore, Maryland through targeted sampling. Ethnographic interviews were conducted to ascertain participants' attitudes toward methadone treatment and their reasons for not seeking treatment. RESULTS: Barriers to treatment entry included: waiting lists, lack of money or health insurance, and requirements to possess a photo identification card. For some participants, beliefs about methadone such as real or rumored side effects, fear of withdrawal from methadone during an incarceration, or disinterest in adhering to the structure of treatment programmes kept them from applying. In addition, other participants were not willing to commit to indefinite "maintenance" but would have accepted shorter time-limited methadone treatment. CONCLUSION: Barriers to treatment entry could be overcome by an infusion of public financial support to expand treatment access, which would reduce or eliminate waiting lists, waive treatment-related fees, and/or provide health insurance coverage for treatment. Treatment programmes could overcome some of the barriers by waiving their photo I.D. requirements, permitting time-limited treatment with the option to extend such treatment upon request, and working with corrections agencies to ensure continued methadone treatment upon incarceration.

First prospective study on brain stem death and attitudes toward organ donation in India.

Organ donation following brain stem death is infrequent in India. There is no prospective study on prevalence of brain stem death and causes of non-donation. Consecutive patients admitted to intensive care unit from Sep 2006 to Sep 2008 were studied prospectively. Families of those with brain stem death were approached for organ donation by transplant coordinator. Extensive awareness drive was launched. Reasons for non-donation, if any, were documented. Of 2820 patients admitted, 994 (35%) were on mechanical ventilator and 657 (23%) died. Brain stem death could be diagnosed in 55, 37 males, median age 46 years (range 7 to 87 years) i.e., 1.9% of all admissions and 8.3% of all deaths. Among neurology and neurosurgery patients brain stem death was seen in 45 of 1037 (4.3%) admissions and 45 of 161 (27.9%) deaths. Complications of brain stem death were hypotension in 49, diabetes insipidus in 17 and hypertension in 5 patients. Of 33 families counselled, 16(48%) consented to organ donation. In 14(42%), organs and tissues retrieved and transplanted included 13 livers, 23 kidneys, 25 corneas and 5 cardiac valves. Consent was more likely in females (10 of 14 as compared to 6 of 19 males, p = 0.037). Consent did not correlate with age of donor or medico-legal issues (p = 0.227 & 0.579 respectively). Trained staff with requisite systems in place produced significant organ donation rates. Religious issues and medico legal concerns were not a major hurdle towards organ donation. Female patients with brain stem were more likely to become organ donors.

Opting out increases HIV testing in a large sexually transmitted infections outpatient clinic.

OBJECTIVES: In January 2007, opt-out HIV testing replaced provider-initiated testing at the sexually transmitted infections (STI) outpatient clinic in Amsterdam, The Netherlands. The effect of the opt-out strategy on the uptake of HIV testing was studied and factors associated with refusal of HIV testing were identified. STUDY DESIGN: Data routinely collected at the STI clinic were analysed separately for men who have sex with men (MSM) and heterosexuals. Logistic regression analysis was used to identify factors associated with opting out. RESULTS: In 2007, 12% of MSM and 4% of heterosexuals with (presumed) negative or unknown HIV serostatus declined HIV testing. Refusals gradually decreased to 7% and 2% by the year end. In 2006, before the introduction of opt-out, 38% of MSM and 27% of heterosexuals declined testing. The proportion of HIV-positive results remained stable among MSM, 3.4% in 2007 versus 3.7% in 2006, and among heterosexuals, 0.2% in 2007 versus 0.3% in 2006. In both groups factors associated with opting out were: age >or=30 years, no previous HIV test, the presence of STI-related complaints and no risky anal/vaginal intercourse. Among heterosexuals, men and non-Dutch visitors refused more often; among MSM, those warned of STI exposure by sexual partners and those diagnosed with gonorrhoea or syphilis refused more often. CONCLUSIONS: An opt-out strategy increased the uptake of HIV testing. A sharp increase in testing preceeded a more gradual increase, suggesting time must pass to optimise the new strategy. A small group of visitors, especially MSM, still opt out. Counselling will focus on barriers such as fear and low risk perception among high-risk visitors considering opting out.

Individual, household and community factors associated with HIV test refusal in rural Malawi.

OBJECTIVE: To investigate individual, household and community factors associated with HIV test refusal in a counselling and testing programme offered at population level in rural Malawi. METHODS: HIV counselling and testing was offered to individuals aged 18-59 at their homes. Individual variables were collected by interviews and physical examinations. Household variables were determined as part of a previous census. Multivariate models allowing for household and community clustering were used to assess associations between HIV test refusal and explanatory variables. RESULTS: Of 2303 eligible adults, 2129 were found and 1443 agreed to HIV testing. Test refusal was less likely by those who were never married [adjusted odds ratio (aOR) 0.50 for men (95% CI 0.32; 0.80) and 0.44 (0.21; 0.91) for women] and by farmers [aOR 0.70 (0.52; 0.96) for men and 0.59 (0.40; 0.87) for women]. A 10% increase in cluster refusal rates increased the odds of refusal by 1.48 (1.32; 1.66) in men and 1.68 (1.32; 2.12) in women. Women counsellors increased the odds of refusal by 1.39 (1.00; 1.92) in men. Predictors of HIV test refusal in women were refusal of the husband as head of household [aOR 15.08 (9.39; 24.21)] and living close to the main road [aOR 6.07 (1.76; 20.98)]. Common reasons for refusal were fear of testing positive, previous HIV test, knowledge of HIV serostatus and the need for more time to think. CONCLUSION: Successful VCT strategies need to encourage couples counselling and should involve participation of men and communities.