Where Is the Community Dimension in the Updated Common Rule?

THE PROBLEM: Changes to the Federal Policy for the Pro tection of Human Subjects (the Common Rule) as presented in the Notice of Proposed Rulemaking (NPRM) are both logical and necessary. However, the proposed changes con tinue to focus entirely on the individual and fail to take into account the rapidlyemerging types of research that involve patients and communities directly in the research process.Purpose of Article: We propose several changes and amendments that address the interests of communities and underscore the principle of justice, especially social justice. KEY POINTS: Our recommendations seek to revise human subjects' protections that currently overemphasize individualism and autonomy to reflect a collectivist ethos that would extend protections to communities engaged in medical research. CONCLUSION: We believe this is necessary to effectively and efficiently conduct the types of research that will ultimately rectify health inequities that continue to exist in many communities, but particularly communities of color.

Subclinical hypothyroidism and risk for incident ischemic stroke among postmenopausal women.

BACKGROUND: Subclinical hypothyroidism (SCH) is postulated to increase stroke risk via atherogenic changes associated with abnormal thyroid function. However, the direct relationship of SCH with subsequent stroke is poorly studied. METHODS: In this nested case-cohort study, we prospectively evaluated the association between any SCH and severity of SCH in relation to incident ischemic stroke risk among postmenopausal women in the Women's Health Initiative Observational Study. Trained Women's Health Initiative staff, masked to thyroid status, adjudicated stroke cases. We assessed thyroid function using baseline blood specimens. Women with normal free thyroxine levels and thyrotropin (TSH) levels ≥4.69 mU/L were considered to have SCH. Primary analysis included 639 ischemic stroke cases and 2927 randomly selected subcohort members with an average of seven years of follow-up. RESULTS: The multivariable adjusted hazard ratios (HR) from weighted Cox models were 1.06 (95% confidence interval [CI]: 0.77, 1.46) and 0.99 (95% CI: 0.67, 1.47) for women with any SCH and with mild SCH (TSH 4.69 to 6.99 mU/L), when compared with women with normal thyroid function. The HR for moderate/severe SCH (TSH ≥7.00 mU/L) was modestly elevated (HR: 1.22; 95% CI: 0.73, 2.05). CONCLUSIONS: We found no evidence to suggest an association between SCH and ischemic stroke among healthy postmenopausal women.

Subclinical hypothyroidism and risk for incident myocardial infarction among postmenopausal women.

CONTEXT: Subclinical hypothyroidism (SCH) has been associated with an increased risk for cardiovascular disease. However, few studies have specifically examined the association between SCH and myocardial infarction (MI), and the relationship is poorly understood. OBJECTIVES: The purpose of this study was to evaluate incident MI risk in relation to SCH and severities of SCH among postmenopausal women. METHODS: We used a population-based nested case-cohort design within the Women's Health Initiative observational study to examine the association between SCH and incident first-time MI risk among postmenopausal women in the United States. SCH was assessed using blood specimens collected at baseline. Participants presenting with normal free T4 levels and with thyrotropin levels of greater than 4.68-6.99 mU/L or 7.00 mU/L or greater were defined as having mild SCH or moderate/severe SCH, respectively. MI cases were centrally adjudicated by trained Women's Health Initiative staff. The primary analysis included 736 incident MI cases and 2927 randomly selected subcohort members. Multivariable adjusted Cox-proportional hazard models were used to assess MI risk in relation to SCH. RESULTS: Compared with euthyroid participants, the multivariable adjusted hazard ratio (HR) for participants with any SCH was 1.05 [95% confidence interval (CI) 0.77-1.44]. HRs for participants with mild SCH, moderate/severe SCH, and moderate/severe SCH and the presence of antithyroid peroxidase antibodies (TPOAb) were 0.99 (95% CI 0.67-1.46), 1.19 (95% CI 0.72-1.96), and 0.90 (95% CI 0.47-1.74), respectively. CONCLUSION: We did not find evidence to suggest that SCH is associated with increased MI risk among a population of predominantly older postmenopausal women with no prior history of MI.

Severe preeclampsia and maternal self-report of oral health, hygiene, and dental care.

BACKGROUND: Maternal periodontal disease diagnosed by a detailed oral health examination is associated with preeclampsia. Our objective was to measure the association between maternal self-report of oral symptoms/problems, oral hygiene practices, and/or dental service use before or during pregnancy and severe preeclampsia. METHODS: A written questionnaire was administered to pregnant females at the time of prenatal ultrasound and outcomes were ascertained by chart abstraction. The χ(2) test compared maternal oral symptoms/problems, hygiene practices, and dental service use between females with severe preeclampsia versus normotensive females. Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for severe preeclampsia. RESULTS: A total of 48 (10%) of 470 females reported ≥2 oral symptoms/problems in the 6 months before pregnancy and 77 (16%) since pregnancy. Fifty-one (11%) reported previous periodontal treatment. Twenty-eight (6%) of 470 developed severe preeclampsia. Females with a history of periodontal treatment were more likely to develop severe preeclampsia (aOR = 3.71; 95% CI = 1.40 to 9.83) than females without a history of periodontal treatment. Self-reported oral health symptoms/problems, oral hygiene practices, or dental service use before or during pregnancy were not associated with severe preeclampsia when considered in the context of other maternal risk factors. CONCLUSION: Maternal self-report of previous periodontal treatment before pregnancy is associated with severe preeclampsia.

Knowledge and beliefs regarding oral health among pregnant women.

BACKGROUND: Racial or ethnic and economic disparities exist in terms of oral diseases among pregnant women and children. The authors hypothesized that women of a racial or ethnic minority have less oral health knowledge than do women not of a racial or ethnic minority. Therefore, the authors conducted a study to assess and compare maternal oral health knowledge and beliefs and to determine if maternal race and ethnicity or other maternal factors contributed to women's knowledge or beliefs. METHODS: The authors administered a written oral health questionnaire to pregnant women. The authors calculated the participants' knowledge and belief scores on the basis of correct answers or answers supporting positive oral health behaviors. They conducted multivariable analysis of variance to assess associations between oral health knowledge and belief scores and characteristics. RESULTS: The authors enrolled 615 women in the study, and 599 (97.4 percent) completed the questionnaire. Of 599 participants, 573 (95.7 percent) knew that sugar intake is associated with caries. Almost one-half (295 participants [49.2 percent]) did not know that caries and periodontal disease are oral infections. Median (interquartile range) knowledge and belief scores were 6.0 (5.5-7.0) and 6.0 (5.0-7.0), respectively. Hispanic women had median (interquartile range) knowledge and belief scores significantly lower than those of white or African American women (6.0 [4.0-7.0] versus 7.0 [6.0-7.0] versus 7.0 [6.0-7.0], respectively [P < .001]; and 5.0 [4.0-6.0] versus 6.0 [5.0-7.0] versus 6.0 [5.0-7.0], respectively [P < .001]). Multivariable analysis of variance results showed that being of Hispanic ethnicity was associated significantly with a lower knowledge score, and that an education level of eighth grade or less was associated significantly with a lower belief score. CONCLUSIONS: Pregnant women have some oral health knowledge. Knowledge varied according to maternal race or ethnicity, and beliefs varied according to maternal education. Including oral health education as a part of prenatal care may improve knowledge regarding the importance of oral health among vulnerable pregnant women, thereby improving their oral health and that of their children. CLINICAL IMPLICATIONS: Including oral health education as a part of prenatal care should be considered.

Oral hygiene practices and dental service utilization among pregnant women.

BACKGROUND: Daily oral hygiene and regular dental visits are important components of oral health care. The authors' objective in this study was to examine women's oral hygiene practices and use of dental services during pregnancy. METHODS: The authors developed a written oral health questionnaire and administered it to 599 pregnant women. They collected demographic information, as well as data on oral hygiene practices and use of dental services during pregnancy. They used chi2 and multivariable logistic regression models to assess associations between oral hygiene practice and dental service use during pregnancy and to identify maternal predictor variables. RESULTS: Of the 599 participants, 83 percent (n=497) reported brushing once or twice per day. Twenty-four percent (n=141) reported flossing at least once daily; Hispanic women were more likely to floss than were white or African American women (28 percent [52 of 183] versus 22 percent [54 of 248] versus 19 percent [23 of 121], respectively, P<.001). Seventy-four percent (n=442) of the participants reported having received no routine dental care during pregnancy. Hispanic women were significantly less likely than were black or white women to receive routine dental care during pregnancy (13 percent versus 21 percent versus 36 percent, respectively, P<.001). The authors found that being older than 36 years, being of Hispanic race or ethnicity, having an annual income of less than $30,000, flossing infrequently and receiving no dental care when not pregnant were significantly associated with lack of routine dental care during pregnancy (adjusted odds ratios, 95 percent confidence intervals: 2.56 [1.33-4.92]; 2.19 [1.11-4.29]; 2.02 [1.12-3.65]; 1.86 [1.13-3.07]; and 4.35 [2.5-7.69], respectively). A woman's lack of receiving routine dental care when not pregnant was the most significant predictor of lack of receiving dental care during pregnancy. CONCLUSION: Racial, ethnic and economic disparities related to oral hygiene practices and dental service utilization during pregnancy exist. CLINICAL IMPLICATIONS: Medical and dental care providers who treat women of reproductive age and pregnant women need to develop policy strategies to address this population's access barriers to, and use of, dental care services.

Barriers to adherence to screening mammography among women with disabilities.

OBJECTIVES: Given the lack of screening mammography studies specific to women with disabilities, we compared reasons offered by women with and without disabilities for not scheduling routine screening visits. METHODS: We surveyed women in the Carolina Mammography Registry aged 40 to 79 years (n = 2970), who had been screened from 2001 through 2003 and did not return for at least 3 years, to determine reasons for noncompliance. In addition to women without disabilities, women with visual, hearing, physical, and multiple (any combination of visual, hearing, and physical) limitations were included in our analyses. RESULTS: The most common reasons cited by women both with and without disabilities for not returning for screening were lack of a breast problem, pain and expense associated with a mammogram, and lack of a physician recommendation. Women with disabilities were less likely to receive a physician recommendation. CONCLUSIONS: Women with disabilities are less likely than those without disabilities to receive a physician recommendation for screening mammography, and this is particularly the case among older women and those with multiple disabilities. There is a need for equitable preventive health care in this population.

Racial differences among reasons for participating in research of pregnancy outcomes: the right from the start experience.

BACKGROUND: Historically, racial minorities and women are less likely to participate in medical research than are whites and men. Although much is known about barriers to enrollment for those who decline to participate, much less is known about factors that motivate those who choose to enroll. OBJECTIVE: This study examines the reasons for participation in pregnancy outcomes research and determines whether these reasons varied by race. METHODS: Right From The Start is an ongoing prospective cohort study. Pregnant women aged >or=18 years, who enrolled in and completed the study between December 2000 and June 2003, were interviewed by telephone at the conclusion of their participation and asked about motivators for enrolling. Univariate and bivariate statistics were used to determine the relationship between self-identified race and main reason for participating in the study. Logistic regression was used to adjust for the influence of age, gravidity, education, marital status, and income. RESULTS: A total of 1106 women were interviewed: 735 (66.5%) whites; 285 (25.8%) blacks; 30 (2.7%) Hispanics; and 56 (5.1%) others (Asians, Pacific Islanders). Black women listed a free ultrasound (73/247, 29.6%), contribution to medical knowledge (60/247, 24.3%), wanting to learn about pregnancy health (46/247, 18.6%), and concern about pregnancy health (30.247, 12.1%) as their main reason for participation. Black women were significantly less likely than white women to cite contribution to medical knowledge as the main reason for participation (odds ratio [OR] = 0.44; 95% CI, 0.36-0.63). Blacks were more likely than whites to list wanting to learn about pregnancy health (OR = 3.12; 95% CI, 1.88-5.55) or concern about pregnancy health (OR = 3.0; 95% CI, 1.56-5.94), even after adjusting for age, gravidity, pregnancy loss, education, marital status, and income. CONCLUSIONS: Access to free pregnancy ultrasounds and contribution to medical knowledge were important motivators for both white and black women. However, whereas black women were more likely to report concerns about pregnancy health or pregnancy health education as the main reason for participation, white women were more likely to report a desire to contribute to medical knowledge.