The Emergency Department: Challenges and Opportunities for Suicide Prevention.

Emergency departments (EDs) can offer life-saving suicide prevention care. This article focuses on the ED and emergency services as service delivery sites for suicide prevention. Characteristics of EDs, models of emergency care, ED screening and brief intervention models, and practice guidelines and parameters are reviewed. A care process model for youths at risk for suicide and self-harm is presented, with guidance for clinicians based on the scientific evidence. Strengthening emergency infrastructure and integrating effective suicide prevention strategies derived from scientific research are critical for advancing suicide prevention objectives.

Retaining HIV-infected patients in care: Where are we? Where do we go from here?

Retaining human immunodeficiency virus (HIV)-infected patients in medical care at regular intervals has been shown to be linked to positive health outcomes. This article examines the available literature and research on retention and engagement in care of HIV-infected patients. We identify the extent of the problem of keeping patients engaged in care, as well as analyze which groups of patients are likely to be lost to follow-up. A review of different ways to measure patient retention is considered, as well as some preliminary data that suggest successful ways to re-engage patients in care. The need to ensure that HIV-infected patients are retained in care is a pressing public health issue and one that affects multiple populations. Further research and exchange of information are needed to keep patients in continuous care and to ensure that all patients are provided with regular, high-quality care that achieves both desired patient and population health outcomes.

Participants in phase 1 oncology research trials: are they vulnerable?

Phase 1 oncology trials involve risk and offer a relatively low prospect of benefit to participants. Some claim that participants constitute a vulnerable population requiring special protections. We undertook this study to determine whether phase 1 oncology trial participants have demographic and health status characteristics of a vulnerable population. We reviewed participant demographic and health status data from phase 1 trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute that began between 1991 and 2002 and from 11 previously published studies. Main outcome measures were median age, sex, race/ethnicity, performance status, previous therapy, educational achievement level, and health insurance coverage. Almost 10 000 participants in trials sponsored by the Cancer Therapy Evaluation Program had a median age of 57 years, 90% self-identified as white, 93% had near-normal performance status, 85% had some form of health insurance, and 92% had been previously treated for cancer; 20 000 individuals from published studies had comparable profiles. The demographic and health status characteristics of phase 1 oncology trial participants are not those of a conventional vulnerable population and suggest little reason to assume that, as a group, they have a compromised ability to understand information or to make informed and voluntary decisions.

The limits of disclosure: what research subjects want to know about investigator financial interests.

Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially when participation is desired because of illness.

Risks and benefits of phase 1 oncology trials, 1991 through 2002.

BACKGROUND: Previous reviews of phase 1 oncology trials reported a rate of response to treatment of 4 to 6 percent and a toxicity-related death rate of 0.5 percent. These results may not reflect the rates in current phase 1 oncology trials. METHODS: We reviewed all nonpediatric phase 1 oncology trials sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute between 1991 and 2002. We report the rates of response to treatment, of stable disease, of grade 4 toxic events, and of treatment-related deaths. RESULTS: We analyzed 460 trials involving 11,935 participants, all of whom were assessed for toxicity and 10,402 of whom were assessed for a response to therapy. The overall response rate (i.e., for both complete and partial responses) was 10.6 percent, with considerable variation among trials. "Classic" phase 1 trials of single investigational chemotherapeutic agents represented only 20 percent of the trials and had a response rate of 4.4 percent. Studies that included at least one anticancer agent approved by the Food and Drug Administration constituted 46.3 percent of the trials and had a response rate of 17.8. An additional 34.1 percent of participants had stable disease or a less-than-partial response. The overall rate of death due to toxic events was 0.49 percent. Of 3465 participants for whom data on patient-specific grade 4 toxic events were available, 14.3 percent had had at least one episode of grade 4 toxic events. CONCLUSIONS: Overall response rates among phase 1 oncology trials are higher than previously reported, although they have not changed for classic phase 1 trials, and toxicity-related death rates have remained stable. Rates of response and toxicity vary, however, among the various types of phase 1 oncology trials.