Current medicolegal and confidentiality issues in large, multicenter research programs.

The convenience of fast computers and the Internet have encouraged large collaborative research efforts by allowing transfers of data from multiple sites to a single data repository; however, standards for managing data security are needed to protect the confidentiality of participants. Through Dartmouth Medical School, in 1996-1998, the authors conducted a medicolegal analysis of federal laws, state statutes, and institutional policies in eight states and three different types of health care settings, which are part of a breast cancer surveillance consortium contributing data electronically to a centralized data repository. They learned that a variety of state and federal laws are available to protect confidentiality of professional and lay research participants. The strongest protection available is the Federal Certificate of Confidentiality, which supersedes state statutory protection, has been tested in court, and extends protection from forced disclosure (in litigation) to health care providers as well as patients. This paper describes the careful planning necessary to ensure adequate legal protection and data security, which must include a comprehensive understanding of state and federal protections applicable to medical research. Researchers must also develop rules or guidelines to ensure appropriate collection, use, and sharing of data. Finally, systems for the storage of both paper and electronic records must be as secure as possible.

Life expectancy estimation with breast cancer: bias of the declining exponential function and an alternative to its use.

BACKGROUND: Life expectancy gain (LEG) is an outcome measure commonly estimated with a declining exponential function in a Markov model. The accuracy of such estimates has not been objectively evaluated. PURPOSE: To compare LEGs from declining exponential function estimates with those calculated from population data, using published screening mammography studies as examples. METHOD: SEER-based population data are used to compare LEG calculation with declining exponential function estimation and empiric population data in a new model, the "nested" Markov. RESULTS: Analyses of the LEG of mammographic screening based on the declining exponential function significantly overestimate LEGs for younger women and underestimate them for older women. Because of offsetting errors, all-age analyses paradoxically appear accurate. CONCLUSION: Declining exponential function estimates of LEGs for chronic diseases with low mortality rates and long time horizons are liable to significant bias, especially with limited age cohorts.

Referral patterns for the evaluation of non-palpable breast abnormalities.

BACKGROUND: Non-palpable suspicious mammographic abnormalities require image-guided breast biopsies. In this study, we examined primary care physicians' knowledge of breast biopsy procedures for non-palpable lesions and referral patterns for breast biopsies; we also identified channels to disseminate information. METHODS: We mailed a baseline survey to all primary care physicians, surgeons, and radiologists in Vermont. RESULTS: Primary care physicians are more likely to refer for excisional rather than percutaneous biopsy. Unlike surgeons and radiologists who learned about these procedures through journals and professional meetings, primary care physicians' most common source of information was from radiologists. CONCLUSIONS: Information about indications for using percutaneous breast biopsy should be available in journals and at meetings to help primary care providers decide on the most appropriate algorithm of workup for patients with non-palpable suspicious breast abnormalities requiring biopsy.

Assessment of self-reward strategies for maintenance of breast self-examination.

This study examined the relative impact of different self-reward strategies on maintenance of breast self-examination (BSE) practice among 1649 women trained to do BSE. Training groups were randomized into four conditions: (a) self-reward instructions and materials delivered at the end of the BSE training session; (b) self-reward suggestions delivered through the mail each month, contingent upon the BSE performance; (c) external monetary rewards and self-reward suggestions delivered through the mail each month on an intermittent schedule, contingent upon BSE practice; and (d) a no-reward control condition. Follow-up assessments 12 months following training revealed a pattern of evidence in support of the benefits of external monetary rewards and self-reward prompts on BSE frequency and quality; however, it is likely that the value of that condition lies in the external reward component.