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At least 91 records · Page 5Linked to original sources
PubMed2005

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.

Acute Disease↗
PubMed1983

The privilege study.

We evaluated the impact of the Texas limited privilege statute, enacted in 1979, through a questionnaire study of 121 lay persons, 79 patients receiving psychiatric outpatient treatment, and 84 psychiatrists. An almost equal percentage of lay persons and patients knew or guessed correctly that the statute existed (26% v 27%), but only 45% of the psychiatrists knew or guessed correctly that it had been enacted. Lay persons indicated that they might disclose more to a psychiatrist or psychologist if they had statutory protection, but only a few of the patients said they would have sought treatment earlier or would have disclosed more had they known of a privilege statute. Patients reported that they relied more heavily on their psychiatrists' ethics than on the statute to protect their privacy.

Adolescent↗
PubMed1998

Physicians disciplined for sex-related offenses.

CONTEXT: Physicians who abuse their patients sexually cause immense harm, and, therefore, the discipline of physicians who commit any sex-related offenses is an important public health issue that should be examined. OBJECTIVES: To determine the frequency and severity of discipline against physicians who commit sex-related offenses and to describe the characteristics of these physicians. DESIGN AND SETTING: Analysis of sex-related orders from a national database of disciplinary orders taken by state medical boards and federal agencies. SUBJECTS: A total of 761 physicians disciplined for sex-related offenses from 1981 through 1996. MAIN OUTCOME MEASURES: Rate and severity of discipline over time for sex-related offenses and specialty, age, and board certification status of disciplined physicians. RESULTS: The number of physicians disciplined per year for sex-related offenses increased from 42 in 1989 to 147 in 1996, and the proportion of all disciplinary orders that were sex related increased from 2.1% in 1989 to 4.4% in 1996 (P<.001 for trend). Discipline for sex-related offenses was significantly more severe (P<.001) than for non-sex-related offenses, with 71.9% of sex-related orders involving revocation, surrender, or suspension of medical license. Of 761 physicians disciplined, the offenses committed by 567 (75%) involved patients, including sexual intercourse, rape, sexual molestation, and sexual favors for drugs. As of March 1997, 216 physicians (39.9%) disciplined for sex-related offenses between 1981 and 1994 were licensed to practice. Compared with all physicians, physicians disciplined for sex-related offenses were more likely to practice in the specialties of psychiatry, child psychiatry, obstetrics and gynecology, and family and general practice (all P<.001) than in other specialties and were older than the national physician population, but were no different in terms of board certification status. CONCLUSIONS: Discipline against physicians for sex-related offenses is increasing over time and is relatively severe, although few physicians are disciplined for sexual offenses each year. In addition, a substantial proportion of physicians disciplined for these offenses are allowed to either continue to practice or return to practice.

Criminal Law↗
PubMed1998

Physicians disciplined by a state medical board.

CONTEXT: State medical boards discipline several thousand physicians each year. Although certain subgroups, such as those disciplined for malpractice, substance use, or sexual abuse, have been studied, little is known about disciplined physicians as a group. OBJECTIVE: To assess the offenses, contributing factors, and type of discipline of a consecutive series of disciplined physicians. DESIGN: Case-control study on publicly available data matching 375 disciplined physicians with 2 groups of control physicians, one matched solely by locale, and a second matched for sex, type of practice, and locale. SUBJECTS: All disciplined physicians publicly reported by the Medical Board of California from October 1995 through April 1997. MAIN OUTCOME MEASURES: Characteristics of disciplined physicians, offenses leading to discipline, and type of discipline. RESULTS: A total of 375 physicians licensed by the Medical Board of California (approximately 0.24% per year) were disciplined for 465 offenses. The most frequent causes for discipline were negligence or incompetence (34%), abuse of alcohol or other drugs (14%), inappropriate prescribing practices (11%), inappropriate contact with patients (10%), and fraud (9%). Discipline imposed was revocation of medical license (21%), actual suspension of license (13%), stayed suspension of license (45%), and reprimand (21%). Type of offense was significantly associated with severity of discipline (P=.03). In logistic regression models comparing disciplined physicians with controls matched by locale, board discipline was significantly associated with physicians' sex (odds ratio [OR] for women, 0.44; 95% confidence interval [CI], 0.28-0.70) and involvement in direct patient care (OR, 2.56; 95% CI, 1.75-3.75). In the regression model with additional matching criteria, disciplinary action was negatively associated with specialty board certification (OR, 0.42; 95% CI, 0.29-0.60) and positively associated with being in practice more than 20 years (OR, 2.02; 95% CI, 1.39-2.92). CONCLUSIONS: A small but substantial proportion of physicians is disciplined each year for a variety of offenses. Further study of disciplined physicians is necessary to identify physicians at high risk for offenses leading to disciplinary action and to develop effective interventions to prevent these offenses.

California↗
PubMed2001

Mandatory reporting of domestic violence injuries to the police: what do emergency department patients think?

CONTEXT: Laws requiring mandatory reporting of domestic violence to police exist in 4 states. Controversy exists about the risks and benefits of such laws. OBJECTIVE: To examine attitudes of female emergency department patients toward mandatory reporting of domestic violence injuries to police and how these attitudes may differ by abuse status. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey conducted in 1996 of 1218 women patients (72.8% response rate) in 12 emergency departments in California (a state with a mandatory reporting law) and Pennsylvania (without such a law). MAIN OUTCOME MEASURES: Opposition to mandatory reporting to police and the characteristics associated with this belief. RESULTS: Twelve percent of respondents (n = 140) reported physical or sexual abuse within the past year by a current or former partner. Of abused women, 55.7% supported mandatory reporting and 44.3% opposed mandatory reporting (7.9% preferred that physicians never report abuse to police and 36.4% preferred physicians report only with patient consent). Among nonabused women, 70.7% (n = 728) supported mandatory reporting and 29.3% opposed mandatory reporting. Patients currently seeing/living with partners (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1-2.0), non-English speakers (OR, 2.1; 95% CI, 1.4-3.0), and those who had experienced physical or sexual abuse within the last year (OR, 2.2; 95% CI, 1.6-2.9) had higher odds of opposing mandatory reporting of domestic violence injuries. There were no differences in attitudes by location (California vs Pennsylvania). CONCLUSIONS: The efficacy of mandatory reporting of domestic violence to police should be further assessed, and policymakers should consider options that include consent of patients before wider implementation.

Adult↗
PubMed2004

How do institutional review boards apply the federal risk and benefit standards for pediatric research?

CONTEXT: Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, or that the research offers a prospect of direct benefit. Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric research. OBJECTIVE: To determine how IRB chairpersons apply the federal risk and benefit categories for pediatric research. DESIGN, SETTING, AND PARTICIPANTS: Telephone survey, conducted between May and August 2002 of 188 randomly selected chairpersons of IRBs in the Unites States. The survey consisted of 21 questions to assess the application of federal risk standards to research procedures, whether certain interventions offer a prospect of direct benefit to participating children, and the extent to which IRBs use the federal definition of minimal risk when categorizing the risks of research procedures in children. MAIN OUTCOME MEASURES: Responses regarding categorization of the risk level and direct benefits of pediatric research procedures. RESULTS: A single blood draw was the only procedure categorized as minimal risk by a majority (152 or 81%) of the 188 respondents. An electromyogram was categorized as minimal or a minor increase over minimal risk by 100 (53%) and as more than a minor increase over minimal risk by 77 (41%). Allergy skin testing was categorized as minimal risk by 43 IRB chairpersons (23%), a minor increase over minimal risk by 81 (43%), and more than a minor increase over minimal risk by 51 (27%). Regarding benefits, 113 chairpersons (60%) considered added psychological counseling to be a direct benefit, while participant payment was considered a direct benefit by 10% (n = 19). CONCLUSIONS: Application of the federal risk and benefit categories for pediatric research by IRB chairpersons is variable and sometimes contradicted by the available data on risks and the regulations themselves. To protect children from excessive risks while allowing appropriate research, IRB chairpersons need guidance on applying the federal risk and benefit categories and also need data on the risks children face in daily life and during routine physical or psychological tests.

Biomedical Research↗
PubMed2005

Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit.

United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments. Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research. Current data reveal that car trips pose the highest risk of mortality ordinarily encountered by healthy children. On average, these risks are approximately 0.06 per million for children aged 14 years and younger, and approximately 0.4 per million for children aged 15 through 19 years. Riskier, but still ordinary, car trips pose an approximately 0.6 per million chance of death for children aged 14 years and younger and an approximately 4 per million chance of death for children aged 15 through 19 years. Participation in sports represents the upper end of the range of morbidity risks for healthy children. For every million instances of playing basketball, approximately 1900 individuals will sustain injuries, including 180 broken bones and 58 permanent disabilities. These findings suggest IRBs are implementing the federal minimal risk standard too cautiously in many cases. These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards.

Activities of Daily Living↗