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. Risk was assessed by the age-adjusted, average, annual 10-year cumulative incidence rate. RESULTS: Among approximately 2.5 million eligible military personnel, 107 confirmed cases of ALS were identified for an overall occurrence of 0.43 per 100,000 persons per year. A significant elevated risk of ALS occurred among all deployed personnel (RR = 1.92; 95% CL = 1.29, 2.84), deployed active duty military (RR = 2.15, 95% CL = 1.38, 3.36), deployed Air Force (RR = 2.68, 95% CL = 1.24, 5.78), and deployed Army (RR = 2.04; 95% CL = 1.10, 3.77) personnel. Elevated, but nonsignificant, risks were observed for deployed Reserves and National Guard (RR = 2.50; 95% CL = 0.88, 7.07), deployed Navy (RR = 1.48, 95% CL = 0.62, 3.57), and deployed Marine Corps (RR = 1.13; 95% CL = 0.27, 4.79) personnel. Overall, the attributable risk associated with deployment was 18% (95% CL = 4.9%, 29.4%). CONCLUSIONS: Military personnel who were deployed to the Gulf Region during the Gulf War period experienced a greater post-war risk of ALS than those who were not deployed to the Gulf.

A multicenter two by two factorial trial of cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: design of a veterans affairs cooperative study (CSP #470).

The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) Study #470 is a 2 x 2 factorial trial designed to evaluate the hypothesis that both cognitive behavioral therapy (CBT) and aerobic exercise will significantly improve physical function in participants with Gulf War veterans' illnesses (GWVI), and that adding CBT to aerobic exercise will provide further incremental benefit. One thousand three hundred fifty-six veterans will be randomized to one of four treatment arms: CBT plus aerobic exercise plus usual and customary care, aerobic exercise plus usual and customary care, CBT plus usual and customary care, or usual and customary care alone. The study duration is 2.5 years with 1.5 years of intake and 1 year of follow-up. The primary outcome measure is the proportion of veterans improved more than seven units on the physical component summary (PCS) scale of the Short Form Health Survey for Veterans (SF-36V) measured 12 months after randomization. This generic quality-of-life measure was chosen because there is no disease-specific measure for GWVI and the symptoms of GWVI span a wide range of physical manifestations that are related to the domains covered by the PCS scale. Sample size was determined to detect all six pairwise comparisons between the four treatment arms with 90% power and a Bonferroni adjustment for an overall type I error of 0.05 or 0.05/6 = 0.0083. CSP #470 was initiated in May 1999 in 18 VA and two Department of Defense medical centers. To date this represents the largest randomized trial designed to evaluate treatments for individuals with unexplained physical symptoms. This paper will focus on the rationale and unique features of the study design. Control Clin Trials 2001;22:310-332

Multisite randomized controlled trials in health services research: scientific challenges and operational issues.

Although well-designed randomized controlled trials (RCT) provide the strongest evidence regarding causation, only relatively recently have they been used by health services researchers to study the organization, delivery, quality, and outcomes of care. More recent yet is the extension of multisite RCTs to health services research. Such studies offer numerous methodological advantages over single-site trials: (1) enhanced external validity; (2) greater statistical power when studying conditions with a low incidence or prevalence, small event rate in the outcome (eg, mortality), and/or large variance in the outcome (eg, health care costs); and (3) rapid recruitment to provide health care organizations and policy makers with timely results. This paper begins by outlining the advantages of multisite RCTs over single-site trials. It then discusses both scientific challenges (ie, standardizing eligibility criteria, defining and standardizing the intervention, defining usual care, standardizing the data collection protocol, blinded outcome assessment, data management and analysis, measuring health care costs) and operational issues (ie, site selection, randomization procedures, patient accrual, maintaining enthusiasm, oversight) posed by multisite RCTs in health services research. Recommendations are offered to health services researchers interested in conducting such studies.

Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions.

OBJECTIVE: To determine clinical and patient-centered factors predicting non-elective hospital readmissions. DESIGN: Secondary analysis from a randomized clinical trial. CLINICAL SETTING: Nine VA medical centers. PARTICIPANTS: Patients discharged from the medical service with diabetes mellitus, congestive heart failure, and/or chronic obstructive pulmonary disease (COPD). MAIN OUTCOME MEASUREMENT: Non-elective readmission within 90 days. RESULTS: Of 1378 patients discharged, 23.3% were readmitted. After controlling for hospital and intervention status, risk of readmission was increased if the patient had more hospitalizations and emergency room visits in the prior 6 months, higher blood urea nitrogen, lower mental health function, a diagnosis of COPD, and increased satisfaction with access to emergency care assessed on the index hospitalization. CONCLUSIONS: Both clinical and patient-centered factors identifiable at discharge are related to non-elective readmission. These factors identify high-risk patients and provide guidance for future interventions. The relationship of patient satisfaction measures to readmission deserves further study.

Reinventing VA health care: systematizing quality improvement and quality innovation.

The Veterans Health Administration (VHA) in the US Department of Veterans Affairs (VA) manages the largest fully integrated health care system in the United States. In 1995, the VHA initiated a reinvention effort that included the most radical redesign of VA health care to occur since the veterans health care system was formally established in 1946. The 2 paramount goals of this reinvention effort were to ensure the predictable and consistent provision of high-quality care everywhere in the system and to optimize the value of VA health care. Although still a work in progress, dramatic results have been achieved toward these ends during the past 5 years. This article provides an overview of the veterans health care system, and it highlights selected aspects of the system's reengineering. It also describes various steps that have been taken to better manage performance and to systematize quality improvement and quality innovation. This information provides a global context that should facilitate understanding of the genesis and purposes of the Quality Enhancement Research Initiative that is described in other articles in this issue of Medical Care.

Quality Enhancement Research Initiative (QUERI): A collaboration between research and clinical practice.

This article provides an overview of the Quality Enhancement Research Initiative (QUERI), an ambitious attempt to develop a data-driven national quality-improvement program for the Veterans Health Administration (VHA) that is fully integrated within VHA's Strategic Framework for Quality Management, as discussed elsewhere in this supplement. QUERI is designed to ensure the systematic translation of findings and products (quality tools that promote use of research findings) to promote optimal patient outcomes and system-wide improvements. In developing QUERI, a framework was created to integrate structural elements (organizational characteristics) and process considerations (those actions and action sequences associated with positive change) with outcomes (both at the patient level and at the systems level). In developing this framework, a process for translation of evidence into action was born. The QUERI process depends on having or discovering accurate information about what services are needed, who needs them, how they should be provided, and relevant outcomes and costs. This article describes the 6-step QUERI process and presents an overview of relevant programmatic details, including QUERI's rigorous review process, and VHA's unique qualifications for establishing a national model for quality improvement.

US Department of Veterans Affairs medical care system as a resource to epidemiologists.

Epidemiologists have utilized several health care systems with large numbers of enrollees and centralized databases to achieve their research aims. Although containing many of the features that have made certain health care systems valuable to the conduct of epidemiologic research, the US Department of Veterans Affairs (VA) medical care system has not been well utilized by epidemiologists. This article will describe existing and planned features of this health care system that should be of interest to epidemiologists, including centralized databases that capture hospital discharge and outpatient clinic diagnostic data, a planned enrollment file that would contain all persons eligible for VA medical care, and the size and national dispersion of VA medical care facilities. Also, VA leadership has demonstrated an interest in the promotion of epidemiologic research by initiating several new programs, including the creation of three Epidemiologic Research and Information Centers (ERICs) to foster VA epidemiologic research, and announcing a program to support investigator-initiated epidemiologic research projects with VA funding. Epidemiologists with interests in medical problems that afflict veterans should consider partnerships with VA investigators to achieve their research aims.

Research in the Veterans Health Administration: the report of the Research Realignment Advisory Committee.

In 1995 the Under Secretary for Health of the Department of Veterans Affairs constituted the Research Realignment Advisory Committee and charged it with reviewing the VA's research program. After meeting in 1995 and 1996, the committee identified 12 findings, which fall into four broad categories: allocation of research resources among VA research programs, acquisition and protection of resources, stability and maintenance of infrastructure, and outreach and communications. The most far-reaching recommendation was to establish designated research areas so that VA research could be focused more sharply on the specific needs of veterans while maintaining a research base for relatively less common conditions and needs integral to the VA's mission. The second major issue was that research funding should be increased (because it had fallen in inflation-adjusted dollars while the cost of doing research continued to rise). The third major area dealt with operational issues about how research was administered in the newly created system of geographically defined "veterans integrated service networks" and at the medical centers and how research monies flowed to medical centers. The final major area had to do with career development, for the committee considered the recruitment and retention of outstanding junior investigators to be a core function of VA research. The committee's recommendations, some of which have already been implemented, form the basis for strengthening the VA's research enterprise and for fully integrating it within the new structure of health care delivery in the VA.

Emerging research on the treatment of Gulf War veterans' illnesses.

Much of what is known about Gulf War veterans' illnesses is a result of the investment in research by the federal government. Since 1993, the Research Working Group of the Federal Interagency Persian Gulf Veterans Coordinating Board has guided the federal research program. Based on this research, Hodgson and Kipin conclude that the symptom-based conditions reported by Gulf War veterans could be treated through the use of a technique called cognitive behavioral therapy. This past year, the Department of Veterans Affairs launched the largest multisite, randomized, controlled treatment trial of the effectiveness of exercise and cognitive behavioral therapy in relieving the symptoms of ill Gulf War veterans. Despite this important step forward, the Department and its Research Working Group partners continue to explore all aspects of Gulf War veterans' illnesses.

Improving informed consent in clinical trials: a duty to experiment.

Practitioners of clinical trials have a responsibility to ensure that patients' participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. We should test innovations in informed consent in realistic contexts (i.e., in clinical trials) and with randomization, when it is appropriate, at the first opportunity. In this study, we develop a preliminary proposal to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials. We discuss the conceptual, ethical, organizational, and technical bases for such an effort.

Clinical research in the Department of Veterans Affairs: using research to improve patient outcomes.

This brief description of a few VA clinical research activities does not do the program justice but does provide insight concerning priorities and prospects for future clinical research. In addition to doing clinical research, the VA has renewed its commitment to the training and career development of clinical investigators, especially physician investigators. We have had an excellent response to our solicitations for career development awards for medical, surgical, and psychiatric junior faculty who wish to pursue a clinical research career. The continued collaboration between VA and the academic community is critical to this revitalization of our research career development programs. Clinical research short-courses and didactic programs are also available to our investigators through similar collaborative relationships. The future is promising for clinical research in the Department of Veterans Affairs. We enjoy strong support from the Department leadership, Veterans Service Organizations, and many policy makers in Washington who support health related research activities year after year. We work hard to justify their support of and confidence in our abilities to improve health care for the many ill veterans who benefit from our research.

Predictors of mammography use among women veterans.

We examined mammography use patterns of women veterans and explored Veterans Administration (VA) health care use and military experience as predictors of mammography use by this population. We conducted a national telephone survey of women veterans. A sample of 397 women veterans was selected from all military discharges from 1971 through 1994. A 3 x 2 stratification scheme was used: three age groups (35-49, 50-64, > or = 65 years old) and two VA user groups indicating whether (VA user) or not (VA nonuser) they received any health care from a VA Medical Center in the last 5 years. The response rate was 75% (297 of 397). Analyses included bivariate techniques and weighted logistic regression. We found that women veterans told to have a mammogram by a health care professional were more than five times more likely to have ever had a mammogram (OR 5.41, CI 4.63-6.32) and nearly twice as likely to have had a mammogram within the past 2 years (OR 1.81, CI 1.57-2.09) as those who were not told to do so, controlling for age, race, VA user status, and length of military service. Regular VA users were more likely to have had a mammogram ever and within the past 2 years, controlling for other factors. Mammography use was not necessarily at a VA medical center. Interventions that promote better provider-patient communication and target older women veterans may have the most potential benefit. Whether VA health care is filling an important gap in access to mammography for older women veterans is an important policy question and warrants further research.

The cost-effectiveness of a clinical pharmacist intervention among elderly outpatients.

We estimated the cost and cost-effectiveness of a clinical pharmacist intervention known to improve the appropriateness of drug prescribing. Elderly veteran outpatients prescribed at least five drugs were randomized to an intervention (105 patients) or control (103) group and followed for 1 year. The intervention pharmacist provided advice to patients and their physicians during all general medicine visits. Mean fixed and variable costs/intervention patient were $36 and $84, respectively Health services use and costs were comparable between groups. Intervention costs ranged from $7.50-30/patient/unit change in drug appropriateness. The cost to improve the appropriateness of drug prescribing is thus relatively low.