Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials.

OBJECTIVES: The National Cancer Institute (NCI) National Clinical Trials Network performs phase II and III clinical trials, which increasingly rely on the submission of diagnostic formalin-fixed, paraffin-embedded tissue blocks for biomarker assessment. Simultaneously, advances in precision oncology require that clinical centers maintain diagnostic specimens for ancillary, standard-of-care diagnostics. This has caused tissue blocks to become a limited resource for advancing the NCI clinical trial enterprise and the practice of modern molecular pathology. METHODS: The NCI convened a 1-day workshop of multidisciplined experts to discuss barriers and strategic solutions to facilitate diagnostic block submission for clinical trial science, from the perspective of patient advocates, legal experts, pathologists, and clinical oncologists. RESULTS: The expert views and opinions were carefully noted and reported. CONCLUSIONS: Recommendations were proposed to reduce institutional barriers and to assist organizations in developing clear policies regarding diagnostic block submission for clinical trials.

Do US Medical Licensing Applications Treat Mental and Physical Illness Equivalently?

BACKGROUND AND OBJECTIVES: State medical licensing boards are responsible for evaluating physician impairment. Given the stigma generated by mental health issues among physicians and in the medical training culture, we were interested in whether states asked about mental and physical health conditions differently and whether questions focused on current impairment. METHODS: Two authors reviewed physician medical licensing applications for US physicians seeking first-time licensing in 2013 in the 50 states and the District of Columbia. Questions about physical and mental health, as well as substance abuse, were identified and coded as to whether or not they asked about diagnosis and/or treatment or limited the questions to conditions causing physician impairment. RESULTS: Forty-three (84%) states asked questions about mental health conditions, 43 (84%) about physical health conditions, and 47 (92%) about substance use. States were more likely to ask for history of treatment and prior hospitalization for mental health and substance use, compared with physical health disorders. Among states asking about mental health, just 23 (53%) limited all questions to disorders causing functional impairment and just 6 (14%) limited to current problems. CONCLUSIONS: While most state medical licensing boards ask about mental health conditions or treatment, only half limited queries to disorders causing impairment. Differences in how state licensing boards assess mental health raise important ethical and legal questions about assessing physician ability to practice and may discourage treatment for physicians who might otherwise benefit from appropriate care.

"I would never want to have a mental health diagnosis on my record": A survey of female physicians on mental health diagnosis, treatment, and reporting.

INTRODUCTION: Physicians have high rates of suicide and depression. Most state medical boards require disclosure of mental health problems on physician licensing applications, which has been theorized to increase stigma about mental health and prevent help-seeking among physicians. METHODS: We surveyed a convenience sample of female physician-parents on a closed Facebook group. The anonymous 24-question survey asked about mental health history and treatment, perceptions of stigma, opinions about state licensing questions on mental health, and personal experiences with reporting. RESULTS: 2106 women responded, representing all 50 states and the District of Columbia. Most respondents were aged 30-59. Almost 50% of women believed that they had met the criteria for mental illness but had not sought treatment. Key reasons for avoiding care included a belief they could manage independently, limited time, fear of reporting to a medical licensing board, and the belief that diagnosis was embarrassing or shameful. Only 6% of physicians with formal diagnosis or treatment of mental illness had disclosed to their state. CONCLUSIONS: Women physicians report substantial and persistent fear regarding stigma which inhibits both treatment and disclosure. Licensing questions, particularly those asking about a diagnosis or treatment rather than functional impairment may contribute to treatment reluctance.

The perils of SNP microarray testing: uncovering unexpected consanguinity.

BACKGROUND: Although single nucleotide polymorphism chromosomal microarrays identify areas of small genetic deletions or duplications, they can also reveal regions of homozygosity indicative of consanguinity. As more nongeneticists order single nucleotide polymorphism microarrays, they must prepare for the potential ethical, legal, and social issues that result from revelation of unanticipated consanguinity. PATIENT: We describe an infant with multiple congenital anomalies who underwent single nucleotide polymorphism microarray testing. RESULTS: The results of the single nucleotide polymorphism microarray revealed several large regions of homozygosity that indicated identity by descent most consistent with a second-degree or third-degree relative mating (e.g., uncle/niece, half-brother/sister, first cousins). The mother was not aware of the test's potential to reveal consanguinity. When informed of the test results, she reluctantly admitted to being raped by her half-brother around the time of conception. CONCLUSIONS: During the pretesting consent process, providers should inform parents that single nucleotide polymorphism microarray testing could reveal consanguinity. Providers must also understand the psychological implications, as well as the legal and moral obligations, that accompany single nucleotide polymorphism microarray results that indicate consanguinity.

Observational study of telephone consults by stroke experts supporting community tissue plasminogen activator delivery.

OBJECTIVES: Barriers to intravenous (IV) tissue plasminogen activator (tPA) use in ischemic stroke include limited treatment experience of community physicians. Models of acute stroke care have been designed to address these limitations by providing community support. These include support by telephone or televideo, with or without subsequent transport to tertiary care centers. The authors describe the frequency, characteristics, and effect of community phone consultations to a 24/7 stroke "hotline" staffed by stroke physicians at an academic stroke center using such a model. METHODS: Twelve intervention hospitals participating in the INcreasing Stroke Treatment through Interventional behavior Change Tactics (INSTINCT) trial were provided a single-access number ("hotline") for expert consultation on tPA use. Experts consisted of stroke-trained physicians at an academic medical center. Hotline use was not mandated by the study protocol, nor was patient transfer required. Consultants were required to record all treatment questions in a Web-based log. All patients discussed over the hotline and/or treated with tPA in an INSTINCT hospital underwent multilevel chart review by trained nurse coordinators. Cases were linked to logged hotline calls, based on the time of treatment and the initial treating hospital. Physician adjudicators assessed appropriateness of tPA treatment, presence of deviation from standard guidelines, and treatment complications (intracranial hemorrhage [ICH], systemic hemorrhage, or death). RESULTS: Over 27 months, there were a total of 204 hotline calls regarding 116 patients. Ninety-one percent of calls were between 8 a.m. and midnight, and 77% of questions explored issues of eligibility for IV tPA, particularly for minor stroke or improving stroke (26%). A total of 243 patients were treated with IV tPA at the 12 intervention hospitals, 54 of which were following hotline consult. Seventy-six percent of hotline patients in whom tPA was recommended actually received tPA, while 2% of those in whom tPA was not recommended received the medication. There were no differences in protocol deviations (27.8% hotline group vs. 23.8% nonhotline group), incidence of symptomatic ICH (5.6% vs. 7.3%), or in-hospital mortality (5.6% vs. 13.2%). No medico-legal issues have been reported for any case in the study. CONCLUSIONS: Providing tPA decision-making support via telephone consult to community physicians is feasible and safe. Consultants may play a more prominent role in determining tPA ineligibility than acceptance. Future work should include a real-time survey of physician providers to ascertain such potential qualitative benefits of a stroke hotline.

Committee report: Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening.

Newborn screening programs are state based with variable policies. Guidance regarding the retention, storage, and use of portions of newborn screening dried blood spots that remain after screening (residual specimens) was first published in 1996. Since then, newborn screening programs have paid increased attention to specimen storage and usage issues. Standard residual specimen uses include quality assurance and program evaluation, treatment efficacy, test refinement, and result verification. In all cases, privacy and security are primary concerns. In general, two distinct state practices regarding the storage and use of residual newborn screening specimens exist: (1) short-term storage (<3 years), primarily for standard program uses and (2) long-term storage (>18 years), for standard program uses and possible important public health research uses. Recently, there have been concerns in some consumer communities regarding both the potential uses of residual specimens and patient (newborn and family) privacy. To assist in policy improvements that can protect the individual's privacy and allow for important public health uses of residual newborn screening specimens, the Secretary of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children has developed recommendations (with requested action by the Secretary where applicable). This report presents the Committee's recommendations and reviews the pertinent associated issues.

Ethical issues in the conduct of clinical trials in obstructive sleep apnea.

Scientifically rigorous clinical trials are needed to test continuous positive airway pressure's (CPAP) effect on important clinical endpoints known to be associated with obstructive sleep apnea, such as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive function. In this "Special Article," we review the regulatory and ethical issues that surround the design and conduct of CPAP trials, including selection of the appropriate control condition, exclusion criteria, and follow-up duration.

Do radiology and other health care presentations posted on the Internet contain accessible protected health information?

PURPOSE: To determine the prevalence of protected health information (PHI) in PowerPoint presentations available for downloading from the Internet. MATERIALS AND METHODS: No institutional review board approval was needed for this project, which involved no patient subjects. Two Google searches, each limited to PowerPoint files, were performed by using the criteria "Cardiac CT" and "Magnetic Resonance Imaging." The first 100 hits of each search were downloaded from the source Web site. The presentations were examined for the PHI contained on any images, links, or notes pages. RESULTS: Two hundred presentations were evaluated. There were 143 presentations with images, image links, or notes, and 52 (36%) of these contained PHI. There were 129 presentations containing radiologic images; 51 (40%) of these contained PHI, and 31 (24%) showed the patient's name. At least 132 (66%) of the 200 presentations originated from the United States. Thirty-five (37%) of 94 presentations with images, image links, or notes contained PHI. Eighty-six U.S. presentations contained radiologic images; 34 (40%) of these contained PHI, and 19 (22%) showed the patient's name. CONCLUSION: Online or other distributions of PowerPoint presentations that contain radiologic images often contain PHI, and this may violate laws, including the U.S. Health Insurance Portability and Accountability Act.

Potential impact of the HIPAA privacy rule on data collection in a registry of patients with acute coronary syndrome.

BACKGROUND: Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule has the potential to affect data collection in outcomes research. METHODS: To examine the extent to which data collection may be affected by the HIPAA Privacy Rule, we used a quasi-experimental pretest-posttest study design to assess participation rates with informed consent in 2 cohorts of patients eligible for the University of Michigan Acute Coronary Syndrome registry. The pre-HIPAA period included telephone interviews conducted at 6 months that sought verbal informed consent from patients. In the post-HIPAA period, informed consent forms were mailed to ask for permission to call to conduct a telephone interview. The primary outcome measure was the percentage of patients who provided consent. Incremental costs associated with the post-HIPAA period were also assessed. RESULTS: The pre-HIPAA period included 1221 consecutive patients with acute coronary syndrome, and the post-HIPAA period included 967 patients. Consent for follow-up declined from 96.4% in the pre-HIPAA period to 34.0% in the post-HIPAA period (P<.01). In general, patients who returned written consent forms during the post-HIPAA period were older, were more likely to be married, and had lower mortality rates at 6 months. Incremental costs for complying with the HIPAA Privacy Rule were $8704.50 for the first year and $4558.50 annually thereafter. CONCLUSIONS: The HIPAA Privacy Rule significantly decreases the number of patients available for outcomes research and introduces selection bias in data collection for patient registries.