Laura M. Lee

Assessing Research Participants’ Perceptions of their Clinical Research Experiences

Introduction: Participants’ perceptions of their research experiences provide valuable measures of ethical treatment, yet no validated instruments exist to measure these experiences. We conducted focus groups of research participants and professionals as the initial step in developing a validated instrument.

Tolerability of postexposure antiretroviral prophylaxis for occupational exposures to HIV

A substantial body of evidence provides support (but not definitive proof of efficacy) for the use of antiretroviral agents as postexposure prophylaxis for occupational exposures to HIV in the healthcare workplace. Despite the lack of definitive evidence of the efficacy of these agents in this setting, over the past decade this intervention has become the standard of care for healthcare workers who sustain occupational exposures to HIV.Administration of these agents — even for a relatively short 28-day postexposure course — is often fraught with difficulty. All of the agents currently used for postexposure prophylaxis regimens have substantial adverse effects, and significant adverse effects occur in more than two-thirds of individuals electing prophylaxis. This manuscript reiterates current US Federal Government guidelines for the administration of postexposure prophylaxis, specifically noting that zidovudine plus lamivudine (with or without a protease inhibitor) remains the recommended regimen. The paper summarises the significant toxicities associated with nucleoside reverse transcriptase inhibitors (primarily nausea, vomiting, diarrhoea and bone marrow suppression), non-nucleoside reverse transcriptase inhibitors (rash, fever, gastrointestinal symptoms and hepatitis, including hepatic decompensation necessitating liver transplantation) and protease inhibitors (nausea, vomiting, diarrhoea, abdominal pain, hyperglycaemia, hyperlipidaemia, headache and anorexia).As a class, the antiretroviral agents have an extraordinary number of drug interactions. The non-nucleoside reverse transcriptase inhibitors and the protease inhibitors are metabolised through the cytochrome P450 pathway, and the effects of concomitant administration of protease inhibitors with other agents in the same class are discussed, as well as the effects of concomitant administration of protease inhibitors with non-nucleoside agents. The potential for numerous and medically risky drug interactions emphasises the importance of planning antiretroviral prophylaxis in consultation with practitioners or clinical pharmacists who are skilled in the use of these agents and knowledgeable about the potential for significant drug interactions that could either reduce the benefit of prophylaxis or increase the potential for toxicity.Another common problem encountered by individuals managing postexposure prophylaxis programmes relates to the administration of chemoprophylaxis to a pregnant healthcare worker who has sustained an occupational exposure to HIV. We address what is known about the potential for toxicity and emphasise the recently published warning concerning the deaths of pregnant women and their offspring from lactic acidosis while receiving regimens containing stavudine and didanosine.

Suicide in the Medical Setting

BACKGROUND Little is known about suicide in the hospital setting. Although suicide is a major public health concern, the literature on suicide in the medical setting is limited, and accurate data on hospital-based suicides are unavailable. Consequently, the prevalence, demographic characteristics, and risk factors for suicide in this population are unknown. The literature on completed suicides in medical or surgical wards of a general hospital was summarized to generate hypotheses for further investigation regarding in-hospital suicides. METHODS MEDLINE, PsycINFO, IndexCat, and Scopus were queried for English-language articles on inpatient suicides in a general hospital. These data were compared with reports of suicide by psychiatric inpatients and the annual suicide statistics from the U.S. general population. RESULTS Twelve articles detailing 335 suicides in the medical setting were included. Published data on hospital-based suicides are limited by selection bias, incomplete reporting, and a small number of completed suicides. Consequently, no significant setting-specific findings emerge from the existing literature. Reported cases suggest that inpatients who commit suicide in the medical setting may have a different demographic profile and employ different methods of suicide in comparison with individuals who commit suicide in psychiatric settings or the general population. DISCUSSION Given the absence of systematic data collection and the highly variable nature of reported suicides, it could not be determined if clinically relevant distinctions exist between suicides in different health care settings. Prospective and more detailed data collection are needed because a more complete characterization of suicide in medical inpatients may be useful in both prevention approaches and institutional policies with respect to hospital-based suicides.

Emerging viral infections.

The past decade has witnessed the emergence of several significant viral pathogens and the further evolution of additional viral pathogens. Transmitted by a variety of differing routes, these organisms have presented substantial intellectual challenges to medicine of the 20th and 21st centuries. As perhaps the benchmark pathogen of the past decade, HIV has provided medicine and society with a most formidable opponent, and one that has yet to be fully conquered. Nonetheless, a variety of additional viral pathogens have also perplexed medicine over the past 10-15 years.

Aftermath of suicide in the hospital: institutional response.

BACKGROUND A suicide can be a devastating event in the hospital, and few guidelines exist to aid an institutions response. METHOD The authors describe a framework of immediate, short-term and long-term responses in the event of an in-hospital suicide. CONCLUSION Implications for administration, communication, assessment, physical environment, and standards of care throughout the hospital are discussed that are relevant to both general-medical and psychiatric settings. Suggestions for the successful management of the aftermath of a suicide, such as the formation of a multidisciplinary leadership team, are included.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes.

Bethesda hospitals' emergency preparedness partnership: a model for transinstitutional collaboration of emergency responses.

The events of September 11, 2001 identified a need for health care institutions to develop flexible, creative, and adaptive response mechanisms in the event of a local, regional, or national disaster. The 3 major health care institutions in Bethesda, MD-the National Naval Medical Center (NNMC), the Suburban Hospital Healthcare System (SHHS), and the National Institutes of Health Clinical Center (NIHCC)-have created a preparedness partnership that outstrips what any of the institutions could provide independently by pooling complementary resources. The creation of the partnership initially was driven by geographic proximity and by remarkably complementary resources. This article describes the creation of the partnership, the drivers and obstacles to creation, and the functioning and initial accomplishments of the partnership. The article argues that similar proximity and resource relationships exist among institutions at academic centers throughout the United States and suggests that this partnership may serve as a template for other similarly situated institutions.

Adrenocortical Insufficiency: A Medical Emergency

Adrenal insufficiency is a deceptive disorder. Insidious in onset, chronic in nature, it can suddenly progress into an acute life-threatening condition that may mimic disorders of vastly different etiologies. The result can be a lethal delay in diagnosis. Prompt diagnosis and replacement of glucocorticoids and fluids are essential for survival. Acute adrenal insufficiency is frequently an exacerbation of an underlying chronic disorder of the adrenal cortex or pituitary gland. Yet any patient who has been treated with suppressive doses of glucocorticoids (e.g., cortisol, prednisone), experienced overwhelming sepsis, has received anticoagulant therapy, or has endstage metastatic carcinoma may suddenly develop adrenal insufficiency along with its deadly sequela of hypovolemic shock, hyperkalemia, hyponatremia, and hypoglycemia. Successful management of this condition requires not only a heightened clinical awareness of adrenal insufficiency, but effective stress reduction interventions and a thorough patient and family teaching program to support lifelong control of the disease.

Challenges in Managing Patients who have Suspected or Confirmed Ebola Virus Infection at the National Institutes of Health

In September 2014, the National Institutes of Health (NIH) Clinical Center admitted as a patient a physician who had been working in an Ebola treatment unit in Sierra Leone and who had sustained a high-risk needle-stick exposure to Ebola virus. He was flown to the United States and was admitted to the NIH Clinical Center’s Special Clinical Studies Unit (SCSU), a high-containment infectious diseases ward. Although the patient arrived with symptoms consistent with Ebola virus disease (EVD), he fortunately did not develop the infection and was discharged 10 days later. In October 2014, a nurse who was diagnosed with EVD after providing care to a Liberian man who had developed fulminant EVD and died at the Dallas hospital where she worked was transferred to our hospital. She received supportive care, recovered, and was discharged 8 days later. The SCSU, to which both patients were admitted, was originally designed to facilitate management of individuals sustaining occupational exposures to select agents being studied at several U.S. Federal Government-run biosafety level 4 (BSL-4) research laboratories near the NIH. The core SCSU nursing and physician staff had been planning and practicing for several years to provide such care. Donning and doffing techniques, infection control policies, and standard operating procedures had been designed for this possibility. In the weeks prior to the admissions, while the first few repatriated healthcare personnel who had acquired EVD were managed at Emory University and the University of Nebraska, the unit made final preparations for admitting EVD patients: developing staffing rosters; training additional nursing and physician staff; refining and rewriting procedures; and restocking supplies. The reality of admitting patients with EVD revealed a wide range of challenges and surprises that we describe here.