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Charles C Engel

Publications and source records attributed to Charles C Engel.

30 records · Page 2Linked to original sources

Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study.

In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.

Focus Groups↗

The antibiotic treatment trial of Gulf War Veterans' Illnesses: issues, design, screening, and baseline characteristics.

Many veterans who were deployed to the Persian Gulf during the 1990-1991 Gulf War developed multiple unexplained symptoms such as pain, fatigue, and neurocognitive problems. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWVI). Although there is no proven explanation for the cause of GWVI, one fairly widespread explanation is systemic Mycoplasma fermentans infection. The Antibiotic Treatment Trial of GWVI is a randomized placebo-controlled trial to determine whether a 1-year course of doxycycline treatment in deployed Gulf War veterans with GWVI and testing as Mycoplasma species positive will improve their overall functional status as measured by the Physical Component Summary of the SF-36V questionnaire. The study of a multisymptom illness such as GWVI is complicated by the nonspecific nature of the illness, the unknown etiology, and the lack of a widely accepted outcome measure. The presumption of mycoplasma infection raises concerns regarding the methodology for determination of mycoplasma infection, the choice of treatment, and the duration of treatment. However, such a presumption allows the formulation of a clear testable hypothesis that can be tested with treatments with known rates of adverse events and known activity against Mycoplasma species. This paper describes the major issues faced by the investigators during planning, the study design, the patient screening results, and the baseline characteristics of the study patients. There were 2712 patients screened for study entry at 26 Department of Veterans Affairs and two Department of Defense medical centers. Of these, 491 met all study entry criteria and were randomized to either 1 year of doxycycline (200 mg/day) or 1 year of placebo. All patients were seen monthly during treatment and at 6 months after the end of treatment. Study patients had a mean age of 41 years and were mostly male (86%), white (64%), married (68%), and employed full-time (71%).

Adult↗

Multiple idiopathic physical symptoms in the ECA study: competing-risks analysis of 1-year incidence, mortality, and resolution. Epidemiological Catchment Area.

OBJECTIVE: Competing-risks analysis was used to determine the 1-year longitudinal outcomes, including mortality, associated with multiple idiopathic physical symptoms in a population sample. METHOD: The authors analyzed baseline and 1-year follow-up data from the population-based NIMH Epidemiological Catchment Area Study. Multinomial logit regression was used to examine the incidence of multiple idiopathic physical symptoms, resolution of such symptoms, and related mortality among individuals in the general population, with adjustment for demographic characteristics and the presence or absence at baseline of a lifetime diagnosis of major depression, dysthymia, anxiety disorder, and alcohol abuse. Multinomial logit modeling also accounts for the impact of competing outcomes, such as survey nonresponse. RESULTS: Most of the individuals with multiple idiopathic physical symptoms recovered over the ensuing year. The incidence of multiple idiopathic physical symptoms among those without such symptoms at baseline was 1.7%. The predicted mortality among individuals with multiple idiopathic physical symptoms at baseline was higher than for individuals not having such symptoms at baseline (0.28% versus 0.18%). The higher mortality rate among those with multiple idiopathic physical symptoms at baseline persisted after adjustment for covariates and competing outcomes. CONCLUSIONS: Outcomes associated with multiple idiopathic physical symptoms vary widely. Most individuals improve over time. However, the course for a few individuals is less benign than perhaps previously thought. Further research is needed to determine the mechanisms behind increases in mortality related to multiple idiopathic physical symptoms, the predictors of poor prognosis, and whether mortality remains elevated over longer periods of follow-up.

Adult↗

Mental disorders among U.S. military personnel in the 1990s: association with high levels of health care utilization and early military attrition.

OBJECTIVE: Epidemiological studies have shown that mental disorders are associated with reduced health-related quality of life, high levels of health care utilization, and work absenteeism. However, measurement of the burden of mental disorders by using population-based methods in large working populations, such as the U.S. military, has been limited. METHOD: Analysis of hospitalizations among all active-duty military personnel (16.4 million person-years) from 1990 to 1999 and ambulatory visits from 1996 to 1999 was conducted by using the Defense Medical Surveillance System. Rates of hospitalization, ambulatory visits, and attrition from military service were compared for persons with mental disorder diagnoses and those with diagnoses in 15 other ICD-9 disease categories. RESULTS: Mental disorders was the leading category of discharge diagnoses among men and the second leading category among women; 13% of all hospitalizations and 23% of all inpatient bed days were attributed to mental disorders. Six percent of the military population received ambulatory services for mental disorders annually in 1998 and 1999. Among a 1-year cohort of personnel, 47% of those hospitalized for the first time for a mental disorder left military service within 6 months. This attrition rate was significantly different from the rate of only 12% after hospitalization for any of the 15 other disease categories (range=11%-18%) (relative risk=4.04, 95% confidence interval=3.91-4.17). The difference remained significant after controlling for effects of age, gender, and duration of service. CONCLUSIONS: Mental disorders appear to represent the most important source of medical and occupational morbidity among active-duty U.S. military personnel. These findings provide new population-based evidence that mental disorders are common, disabling, and costly to society.

Adolescent↗

Caring for medically unexplained physical symptoms after toxic environmental exposures: effects of contested causation.

Medically unexplained physical symptoms (MUPS) are persistent idiopathic symptoms that drive patients to seek medical care. MUPS syndromes include chronic fatigue syndrome, fibromyalgia syndrome, and multiple chemical sensitivities. When MUPS occur after an environmental exposure or injury, an adversarial social context that we call "contested causation" may ensue. Contested causation may occur publicly and involve media controversy, scientific disagreement, political debate, and legal struggles. This adversarial social context may diminish the effectiveness of the provider-patient relationship. Contested causation also may occur privately, when disagreement over the causes of MUPS takes place in the patient-provider context. These patient-provider disagreements over causation often occur because of the enigmatic nature of MUPS. We suggest that a context of contested causation may have serious negative effects on healthcare for individuals with MUPS. Context plays a larger role in MUPS care than it does for most medical care because of the uncertain nature of MUPS, the reliance of standard MUPS therapies on a potentially tenuous patient-provider partnership, and the clinical need to rely routinely on subjective MUPS assessments that often yield discordant patient and provider conclusions. Contested causation may erode patient-provider trust, test the provider's self-assurance and capacity to share power with the patient, and raise problematic issues of compensation, reparation, and blame. These issues may distract patients and providers from therapeutic goals. In occupational and military settings, the adverse impact of contested causation on the patient-provider partnership may diminish therapeutic effectiveness to a greater degree than it does in other medical settings. Contested causation therefore raises questions regarding generalizability of standard therapies for MUPS and related syndromes to these settings. Future research is needed to learn whether intuitively sensible and evidence-based MUPS therapies benefit occupational and military medical patients who are afforded care in the context of contested causation.

Cognitive Behavioral Therapy↗

The Recruit assessment Program: a program to collect comprehensive baseline health data from U.S. military personnel.

Pilot testing has begun on the Recruit Assessment Program (RAP). The RAP is a proposed Department of Defense (DoD) program for the routine collection of baseline demographic, medical, psychosocial, occupational, and health risk factor data from all U.S. military personnel at entry into the armed forces. The RAP currently uses an optically scannable paper questionnaire, which will provide data for the first building block of an electronic medical record within the DoD and the Department of Veterans Affairs. The RAP will serve several important functions, including automating enrollment into the military health care system, improving patient care and preventive medicine efforts, and providing critical data for investigations of health problems among military personnel and veterans. If the feasibility of the RAP is demonstrated and the program is fully implemented throughout the DoD, it could provide a substantial improvement in health care delivery. For the first time, DoD and Department of Veterans Affairs physicians, public health officers, and researchers will have access to comprehensive baseline health status data.

Feasibility Studies↗

Clinical management of Gulf War veterans with medically unexplained physical symptoms.

Veterans of the Persian Gulf War have increased rates of medically unexplained physical symptoms (MUPS). This article describes a model for the clinical management of MUPS in Gulf War veterans. Predisposing, precipitating, and perpetuating factors contribute to the emergence and clinical course of MUPS. Predisposing factors include biologically and psychosocially determined vulnerabilities that render individuals more susceptible to MUPS and related morbidity. Precipitating factors promote the onset of MUPS. These factors are triggering events that serve to initiate episodes of MUPS. Perpetuating factors sustain illness. They maintain, exacerbate, or prolong MUPS and associated distress and disability. Intervention involves identifying and addressing all relevant predisposing, precipitating, and perpetuating factors. A representative patient vignette is presented to illustrate the clinical utility of the model for a Gulf War veteran with MUPS.

Adult↗

Using general population data to project idiopathic physical symptoms in the U.S. Army.

Many personnel deployed to the 1991 Persian Gulf War complained of symptoms that sometimes remained unexplained after comprehensive clinical examinations. We used existing population-based data from the Epidemiologic Catchment Area survey to estimate the expected incidence, prevalence, resolution, and mortality for multiple idiopathic physical symptoms (MIPS) among Army active duty personnel. Multinomial logistic regression was used to model the relationship between sociodemographic characteristics and the distribution of MIPS in U.S. workers. We used logit coefficients and known sociodemographic characteristics of U.S. Army active duty personnel to predict MIPS status in the Army. High, medium, and low estimates of MIPS incidence, prevalence, resolution, and MIPS-related mortality were obtained by altering logit intercepts. Among workers, the estimated MIPS prevalence and annual incidence, resolution, and mortality were 4.62%, 2.11%, 63.85%, and 0.26%, respectively. In contrast, the same predicted rates among Army active duty personnel were 3.89%, 1.64%, 71.33%, and 0.15%.

Adult↗

Operation Solace: overview of the mental health intervention following the September 11, 2001 Pentagon attack.

At the direction of the Army Surgeon General, the Army behavioral health consultants in psychiatry, psychology, and social work assembled in Washington, DC immediately after the September 11, 2001 attack to plan and implement a proactive behavioral health response to the Pentagon attack. The goal was to minimize the short- and long-term adverse behavioral health and related medical effects predicted to emerge based on past U.S. mass casualty scenarios. This article summarizes the goals, methods, and rationale used to develop the plan, as well as the key elements of the behavioral health intervention developed in response to the attack.

Aircraft↗

Development of a brief questionnaire to measure mental health outcomes among Pentagon employees following the September 11, 2001 attack.

In the aftermath of the terrorist action at the Pentagon there was a critical operational need to understand and document the extent of injuries, illnesses, and exposures sustained by Service members and civilian employees at the Pentagon. It was decided to develop and administer a brief questionnaire to the Pentagon employees that would contain questions about exposures, new or worsening injuries or illnesses, mental health, and factors suggested by the literature to increase risk or be protective for these outcomes. This report describes the development the mental health portion of this questionnaire. Most mental health instruments are very lengthy, limiting their usefulness as rapid public health assessment tools. This brief instrument was designed to cover four main symptom domains, as well as key risk/protective factors, thought to be most important following the terrorist attack. The symptom domains were: acute and post-traumatic stress symptoms, depression, anxiety/panic attacks, and alcohol abuse. Further analyses will assess the usefulness of this questionnaire as a public health tool for rapid assessment of mental health symptoms following the attack.

Aircraft↗

Are veterans seeking Veterans Affairs' primary care as healthy as those seeking Department of Defense primary care? A look at Gulf War veterans' symptoms and functional status.

OBJECTIVE: This study compared Gulf War veterans seeking VA primary care with Gulf War veterans seeking treatment from a Department of Defense primary care clinic on measures of physical symptoms, psychiatric complaints, and functional status. Additionally, the association between employment status and health was examined. METHODS: Analysis was based on the responses of consecutive patients attending the Gulf War Primary Care clinics at either the VA Puget Sound Health Care System in Seattle, WA (N= 223), or the Walter Reed Army Medical Center in Washington, DC (N= 153), between March 1998 and September 1999. RESULTS: After controlling for demographic variables, Gulf War veterans who sought VA care reported significantly more anxiety and PTSD symptoms than active duty military personnel. The groups did not differ on somatic complaints or summary scores from the SF-36. Employment status was significantly, independently, and consistently associated with greater psychiatric symptoms, physical symptoms, and decreased functional status. CONCLUSIONS: Our findings reveal important differences in health status between veterans seeking primary care at a VA and a Department of Defense facility, differences that are in part related to employment status. Both groups report symptoms of psychiatric distress and decreased functional status, though VA patients are more impaired. Research findings based on clinical samples of veterans at VA sites may not generalize to Gulf War veterans still on active duty (and vice versa).

Adult↗