Change, Challenge and Opportunity: Departments of Medicine and Their Leaders.

Academic Health Centers are evolving to larger and more complex Academic Health Systems (AHS), reflecting financial stresses requiring them to become nimble, efficient, and patient (consumer) and faculty (employee) focused. The evolving AHS organization includes many positive attributes: unity of purpose, structural integration, collaboration and teamwork, alignment of goals with resource allocation, and increased financial success. The organization, leadership, and business acumen of the AHS influence directly opportunities for Departments of Medicine.

Communicating and advocating for science and medicine: beyond the basics.

I have discussed several advocacy strategies to improve effective communications for those motivated to do the necessary work to make a difference in policy decisions involving science and health care. I encourage you to get involved personally with members of Congress, their key “staffers,” and to contribute financially to their election efforts. Other suggestions are self-evident, for example, think strategically, only advocate for important policies and do not “over promise” or “under deliver.

Clinical aspects of ALS in Gulf War veterans.

The increased incidence of ALS in military veterans of the first Persian Gulf War raised speculation that they may have a 'Persian Gulf' variant of ALS with atypical clinical features. Medical records of military veterans with ALS, previously identified in our epidemiological study, were evaluated for clinical features (age and site of onset, race, unexplained atypical findings) and ventilator-free survival. Comparisons between deployed versus non-deployed cohorts were made with deployment status based on designation by the Department of Defense Manpower Data Center (DMDC) or by self-report.

The effect of geriatrics evaluation and management on nursing home use and health care costs: results from a randomized trial.

Background: The Geriatric Evaluation and Management study was developed to assess the impact of a comprehensive geriatric assessment service on the care of the elderly.

Objectives: We sought to evaluate the cost and clinical impact of inpatient units and outpatient clinics for geriatric evaluation and management.

Research Design: We undertook a prospective, randomized, controlled trial using a 2x2 factorial design, with 1-year follow-up.

Geriatric evaluation and management units in the care of the frail elderly cancer patient.

Background: Geriatric assessment has been suggested as a possibly useful approach in dealing with frail elderly cancer patients.

Methods: This was a secondary subset analysis from a randomized 2 x 2 factorial trial in 11 Department of Veterans Affairs medical centers. Hospitalized, frail patients at least 65 years old, after stabilization of their acute illness, were randomized to receive care in a geriatric inpatient unit, a geriatric outpatient clinic, both, or neither.

Creating a new structure for research on health care effectiveness.

Effectiveness research (a term we use in preference to the more confining and difficult health services or outcomes research) evaluates the clinical setting and the health care system on which it depends. It uses a variety of health care assessment techniques and the practical clinical trial to inform clinical practice, quality interventions, and health policy decisions. Effectiveness research had not had sufficient public or private funding to produce the information needed to facilitate evidence-based health care improvement.

Enrollment in clinical trials according to patients race: experience from the VA Cooperative Studies Program (1975-2000).

Background: Racial distribution of clinical trial participants is important because results from these studies serve to define evidence-based practice. This report summarizes the experience of the VA Cooperative Studies Program (CSP) in enrolling white, black and Hispanic patients.

Methods: An analysis of enrollment in randomized controlled trials conducted by VA CSP between 1975 and 2000.

Benefits and harms of doxycycline treatment for Gulf War veterans' illnesses: a randomized, double-blind, placebo-controlled trial.

Background: It has been hypothesized that certain Mycoplasma species may cause Gulf War veterans' illnesses (GWVIs), chronic diseases characterized by pain, fatigue, and cognitive symptoms, and that affected patients may benefit from doxycycline treatment.

Objective: To determine whether a 12-month course of doxycycline improves functional status in Gulf War veterans with GWVIs.

Design: A randomized, double-blind, placebo-controlled clinical trial with 12 months of treatment and 6 additional months of follow-up.

Effects of geriatric evaluation and management on adverse drug reactions and suboptimal prescribing in the frail elderly.

Purpose: To determine if inpatient or outpatient geriatric evaluation and management, as compared with usual care, reduces adverse drug reactions and suboptimal prescribing in frail elderly patients.

Methods: The study employed a randomized 2 x 2 factorial controlled design. Subjects were patients in 11 Veterans Affairs (VA) hospitals who were > or =65 years old and met criteria for frailty (n = 834).

Occurrence of amyotrophic lateral sclerosis among Gulf War veterans.

Background: In response to Gulf War veterans' concerns of high rates of ALS, this investigation sought to determine if Gulf War veterans have an elevated rate of ALS.

Methods: A nationwide epidemiologic case ascertainment study design was used to ascertain all occurrences of ALS for the 10-year period since August 1990 among active duty military and mobilized Reserves, including National Guard, who served during the Gulf War (August 2, 1990, through July 31, 1991). The diagnosis of ALS was confirmed by medical record review.

Promoting good clinical practices in the conduct of clinical trials: experiences in the Department of Veterans Affairs Cooperative Studies Program.

The ever-increasing concern for the welfare of volunteers participating in clinical trials and for the integrity of the data derived from those trials has generated the concept of Good Clinical Practice (GCP). The Veterans Affairs Cooperative Studies Program, in anticipation of the need to comply with GCP guidelines, developed a Site Monitoring and Review Team (SMART), which consists of a Good Clinical Practice Monitoring Group and a Good Clinical Practice Review Group. The review group conducted 335 site reviews from fiscal years (FY) 1999 through 2001 to assess and encourage adherence to GCP.

An overview of variance inflation factors for sample-size calculation.

For power and sample-size calculations, most practicing researchers rely on power and sample-size software programs to design their studies. There are many factors that affect the statistical power that, in many situations, go beyond the coverage of commercial software programs. Factors commonly known as design effects influence statistical power by inflating the variance of the test statistics.