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.

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.