Timing of neuroprognostication in postcardiac arrest therapeutic hypothermia*.

OBJECTIVE: Early assessment of neurologic recovery is often challenging in survivors of cardiac arrest. Further, little is known about when to assess neurologic status in comatose, postarrest patients receiving therapeutic hypothermia. We sought to evaluate timing of prognostication in cardiac arrest survivors who received therapeutic hypothermia. DESIGN: A retrospective chart review of consecutive postarrest patients receiving therapeutic hypothermia (protocol: 24-hr maintenance at target temperature followed by rewarming over 8 hrs). Data were abstracted from the medical chart, including documentation during the first 96 hrs post arrest of "poor" prognosis, diagnostic tests for neuroprognostication, consultations used for determination of prognosis, and outcome at discharge. SETTING: Two academic urban emergency departments. PATIENTS: A total of 55 consecutive patients who underwent therapeutic hypothermia were reviewed between September 2005 and April 2009. INTERVENTION: None. RESULTS: Of our cohort of comatose postarrest patients, 59% (29 of 49) were male, and the mean age was 56 ± 16 yrs. Chart documentation of "poor" or "grave" prognosis occurred "early": during induction, maintenance of cooling, rewarming, or within 15 hrs after normothermia in 57% (28 of 49) of cases. Of patients with early documentation of poor prognosis, 25% (seven of 28) had care withdrawn within 72 hrs post arrest, and 21% (six of 28) survived to discharge with favorable neurologic recovery. In the first 96 hrs post arrest: 88% (43 of 49) of patients received a head computed tomography, 90% (44 of 49) received electroencephalography, 2% (one of 49) received somatosensory evoked potential testing, and 71% (35 of 49) received neurology consultation. CONCLUSIONS: Documentation of "poor prognosis" occurred during therapeutic hypothermia in more than half of patients in our cohort. Premature documentation of poor prognosis may contribute to early decisions to withdraw care. Future guidelines should address when to best prognosticate in postarrest patients receiving therapeutic hypothermia.

Infected physicians and invasive procedures: safe practice management.

There is currently no public policy that provides guidance concerning whether and when physicians infected with hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) can safely perform invasive procedures. A committee of experts in the fields of medicine, law, and biomedical ethics and 1 community member, aided by an advisory board, was established to produce recommendations for policy reform. An extensive literature review was conducted for these 3 infectious diseases, medicine, surgery, epidemiology, law, and bioethics to gather all relevant data. Special recommendations are made regarding the management of physicians who are infected with HIV, HBV, and/or HCV. This policy proposal includes a list of exposure-prone procedures and a decision chart that indicates under what conditions infected physicians can practice beyond the need for disclosure of their serological status.

Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudes.

BACKGROUND: Innovative surgery is not clearly defined, nor is it formally regulated by governing bodies as is the development of drugs and medical devices. This unclear status and the subsequent questionable applicability of existing federal guidelines for human subject research pose an ethical concern. To clarify its position, we solicited US surgeons' definitions of, opinions toward, and attitudes about innovative surgery. Surgeons were also invited to self-report knowledge about current federal regulations guiding human subject research and rules for informed consent for and IRB review of clinical research. STUDY DESIGN: A group of US surgeons received a 46-item questionnaire addressing the definition of innovative surgery versus those for research and practice, regulations for human subject research, need for specific informed consent, and IRB review of surgical innovations. RESULTS: A total of 665 responses were used in the content analysis. Respondents expressed a fairly prudent stance when judging hypothetical innovative scenarios. Hallmarks for experimentation and clinical research as modes of innovation were defined more clearly for the surgical situation. CONCLUSIONS: Defining criteria exist that prompt added scrutiny and previous review of surgical innovations. Some forms of innovation clearly fall under the current regulations for human subject research; others might not fully meet the definition but could still require some additional oversight.

Ethical regulations for innovative surgery: the last frontier?

BACKGROUND: There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research. STUDY DESIGN: In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire. RESULTS: The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate. CONCLUSIONS: The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.

Maternal-fetal research and human research protections policy.

It may be that the current system of formal definitions, ethical theories, and voluntary professional guidelines to protect patients from unwittingly becoming subjects of research is inadequate to meet the challenge of surgical innovation. Important questions, such as when surgical innovation becomes research involving human subjects or how to distinguish between variations on an existing technique and true innovations, are key. These questions also apply to MFS as an innovative surgical therapy. Now that MFS has been recognized as experimental and formal clinical trials will be conducted, it is important to ensure adequate protection of the pregnant women and fetuses involved as human research subjects. This issue is even more pertinent in light of the new regulations regarding fetuses as research subjects. Those responsible for reviewing study protocols will have to be especially careful when examining the new version of DHHS regulations as they apply to future studies in the field of MFS.

Experiences of sudden cardiac arrest survivors regarding prognostication and advance care planning.

OBJECTIVE: We sought to better understand SCA survivors' beliefs about complex issues that arise in the immediate post-arrest period and explore advance care planning. Specifically, we wished to explore four themes: (1) patient and family perception of medical providers' prognostication in the immediate post-arrest phase; (2) patient definitions of death; (3) use of advance directives (ADs); and (4) perceptions of health and organ donation. METHODS: We conducted a qualitative study of adult arrest survivors using semi-structured telephone interviews. Participants were recruited from a nonprofit national organization for SCA. RESULTS: Nine of 11 subjects contacted completed the survey. In the immediate post-arrest phase, subjects believed that medical professionals made errors in giving poor prognosis early in the course of resuscitation. While some subjects felt they had experienced "death," some subjects felt the term "death" was an inappropriate term to describe their experience. The majority of the subjects did not have an AD prior to their SCA and no subjects reported having a conversation about ADs with their medical team. While the majority of subjects classified their health as "very good" or "excellent," few subjects were registered organ donors, citing comorbidities and skepticism about future resuscitative efforts as rationale. CONCLUSIONS: Our study elucidated the attitudes and experiences of SCA survivors. Variability in prognostication timing and inconsistency in describing SCA can complicate discussions between the medical team and families. AD and organ donation discussions may help to provide sensitive care concordant with a patient's wishes.