Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

HealthViEWS: mortality study of female US Vietnam era veterans, 1965-2010.

We conducted a retrospective study among 4,734 women who served in the US military in Vietnam (Vietnam cohort), 2,062 women who served in countries near Vietnam (near-Vietnam cohort), and 5,313 nondeployed US military women (US cohort) to evaluate the associations of mortality outcomes with Vietnam War service. Veterans were identified from military records and followed for 40 years through December 31, 2010. Information on underlying causes of death was obtained from death certificates and the National Death Index. Based on 2,743 deaths, all 3 veteran cohorts had lower mortality risk from all causes combined and from several major causes, such as diabetes mellitus, heart disease, chronic obstructive pulmonary disease, and nervous system disease relative to comparable US women. However, excess deaths from motor vehicle accidents were observed in the Vietnam cohort (standardized mortality ratio = 3.67, 95% confidence interval (CI): 2.30, 5.56) and in the US cohort (standardized mortality ratio = 1.91, 95% CI: 1.02, 3.27). More than two-thirds of women in the study were military nurses. Nurses in the Vietnam cohort had a 2-fold higher risk of pancreatic cancer death (adjusted relative risk = 2.07, 95% CI: 1.00, 4.25) and an almost 5-fold higher risk of brain cancer death compared with nurses in the US cohort (adjusted relative risk = 4.61, 95% CI: 1.27, 16.83). Findings of all-cause and motor vehicle accident deaths among female Vietnam veterans were consistent with patterns of postwar mortality risk among other war veterans.

Diagnostic accuracy of the Composite International Diagnostic Interview (CIDI 3.0) PTSD module among female Vietnam-era veterans.

The World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) posttraumatic stress disorder (PTSD) module is widely used in epidemiological studies of PTSD, yet relatively few data attest to the instrument's diagnostic utility. The current study evaluated the diagnostic utility of the CIDI 3.0 PTSD module with U. S. women Vietnam-era veterans. The CIDI and the Clinician-Administered PTSD Scale (CAPS) were independently administered to a stratified sample of 160 women, oversampled for current PTSD. Both lifetime PTSD and recent (past year) PTSD were assessed within a 3-week interval. Forty-five percent of the sample met criteria for a CAPS diagnosis of lifetime PTSD, and 21.9% of the sample met criteria for a CAPS diagnosis of past-year PTSD. Using CAPS as the diagnostic criterion, the CIDI correctly classified 78.8% of cases for lifetime PTSD (κ = .56) and 82.0% of past year PTSD cases (κ = .51). Estimates of diagnostic performance for the CIDI were sensitivity of .61 and specificity of .91 for lifetime PTSD and sensitivity of .71 and specificity of .85 for past-year PTSD. Results suggest that the CIDI has good utility for identifying PTSD, though it is a somewhat conservative indicator of lifetime PTSD as compared to the CAPS.

Four Decades after War: Incident Diabetes among Women Vietnam-Era Veterans in the HealthViEWS Study.

OBJECTIVES: We analyzed long-term differences in incident diabetes associated with military service in a warzone among women who served during the Vietnam War era. METHODS: For HealthViEWS, the largest later-life study of women Vietnam War-era U.S. veterans, a population-based retrospective cohort who served during 1965-1973 completed a health interview in 2011-2012. This cohort included women deployed to Vietnam, near Vietnam, or who served primarily in the United States. We hypothesized a warzone exposure gradient: Vietnam (highest exposure), near Vietnam, and the United States (lowest exposure). We used an extended Cox regression to test for differences in incident diabetes by location of wartime service. RESULTS: Of 4,503 women in the analysis, 17.7% developed diabetes. Adjusting for demographics and military service characteristics, hazard of incident diabetes was significantly lower initially in the Vietnam group compared with the U.S. group (hazard ratio, 0.33; 95% confidence interval, 0.15-0.69). However, lower diabetes hazard in the Vietnam group was not constant over time; rather, hazard accumulated faster over time in the Vietnam group compared with the U.S. group (hazard ratio, 1.38; 95% confidence interval, 1.11-1.72). No significant difference in diabetes hazard was found between the near Vietnam and U.S. groups. Older age during military service, minority race/ethnicity, and lower military rank were associated with a higher diabetes hazard. CONCLUSIONS: Women deployed to a warzone might have protective health factors that lower risk for diabetes early in their military career, but delivery systems for long-term health should consider that a lower risk for chronic diseases like diabetes can wane quickly in the decades that follow warzone service.

Assessment of a Revised Wartime Experiences Scale for Vietnam-Era Women: The Health of Vietnam-Era Women's Study (HealthViEWS).

PURPOSE: Few wartime experiences scales capture unique issues related to women's service, address their military roles, or have been validated with women. The Women's Wartime Stressor Scale was developed for use with women who served during the Vietnam era, primarily as nurses in Vietnam. We revised this measure by modifying existing items, adding new items, and revising response formats to create a scale less nursing specific and nondeployment specific, and conducted a preliminary assessment of the revised scale. METHODS: The Women's Wartime Exposure Scale-Revised (WWES-R) was included in a mail survey as part of the U.S. Department of Veterans Affairs Health of Vietnam-Era Women's Study (HealthViEWS) study. Construct and criterion validity, and internal consistency, were assessed with a sample of 4,839 women veterans using exploratory factor analysis, analysis of variance, and multiple linear regression. RESULTS: Six wartime experience factors consistent with previous research were identified and scales were created based on salient item loadings. Compared with women serving in the United States, women serving in Vietnam had higher mean scores on all scales, and nurses had significantly higher scores on three scales than non-nurses. CONCLUSIONS: Evaluation of the WWES-R suggests service and/or deployment location and service in a military health care versus a non-health care role may predict women veterans' reports of certain wartime experiences. Further psychometric evaluation of the WWES-R is recommended with later era veterans and through comparisons to other wartime exposure measures.

Design and challenges for a randomized, multi-site clinical trial comparing the use of service dogs and emotional support dogs in Veterans with post-traumatic stress disorder (PTSD).

Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD. Trial design considerations prioritized participant and intervention (dog) safety, selection of an intervention comparison group that would optimize enrollment in all treatment arms, pragmatic methods to ensure healthy well-trained dogs, and the selection of outcomes for achieving scientific and clinical validity in a Veteran PTSD population. Since there is no blueprint for conducting a randomized clinical trial examining the impact of dogs on PTSD of this size and scope, it is our primary intent that the successful completion of this trial will set a benchmark for future trial design and scientific rigor, as well as guiding researchers aiming to better understand the role that dogs can have in the management of Veterans experiencing mental health conditions such as PTSD.

Physical Health Conditions Among a Population-Based Cohort of Vietnam-Era Women Veterans: Agreement Between Self-Report and Medical Records.

BACKGROUND: Little is known about medical morbidity among women Vietnam-era veterans, or the long-term physical health problems associated with their service. This study assessed agreement comparing data on physical health conditions from self-report and medical records from a population-based cohort of women Vietnam-era Veterans from the Health of Vietnam Era Women's Study (HealthViEWS). MATERIALS AND METHODS: Women Vietnam-era veterans (n = 4219) self-completed a survey and interview on common medical conditions. A subsample (n = 900) were contacted to provide permission to obtain medical records from as many as three of their providers. Medical record reviews were conducted using a standardized checklist. Agreement and kappa (agreement beyond chance) were calculated for physical health condition groups. RESULTS: Of the 900, 449 had medical records returned, and of those, 412 had complete surveys/interviews. The most commonly reported conditions based on self-report or medical record review included hypertension, hyperlipidemia, or arthritis. Kappa scores between self-reported conditions and medical record documentation were 0.75-0.91 for hypertension, diabetes, most cancers, and neurological conditions, but lower (k = 0.29-0.55) for cardiovascular diseases, musculoskeletal, and gastrointestinal conditions. Generally, agreement did not significantly vary by different sociodemographic groups. CONCLUSIONS: There was relatively high agreement for physical health conditions when self-report was compared with medical record review. As more women are increasingly represented in the military and more veterans in general seek care outside the Veterans Health Administration, accurate measurement of physical health conditions among population-based samples is crucial.

Prevalence of Posttraumatic Stress Disorder in Vietnam-Era Women Veterans: The Health of Vietnam-Era Women's Study (HealthVIEWS).

IMPORTANCE: Many Vietnam-era women veterans served in or near war zones and may have experienced stressful or traumatic events during their service. Although posttraumatic stress disorder (PTSD) is well studied among men who served in Vietnam, no major epidemiologic investigation of PTSD among women has been performed. OBJECTIVES: To assess (1) the onset and prevalence of lifetime and current PTSD for women who served during the Vietnam era, stratified by wartime location (Vietnam, near Vietnam, or the United States), and (2) the extent to which wartime location was associated with PTSD, with adjustment for demographics, service characteristics, and wartime exposures. DESIGN, SETTING, AND PARTICIPANTS: Survey of 8742 women who were active-duty military personnel in the US Armed Forces at any time from July 4, 1965, through March 28, 1973, and alive as of survey receipt as part of Department of Veterans Affairs Cooperative Study 579, HealthVIEWS. Data were obtained from mailed and telephone surveys from May 16, 2011, through August 5, 2012, and analyzed from June 26, 2013, through July 30, 2015. MAIN OUTCOMES AND MEASURES: Lifetime and current PTSD as measured by the PTSD module of the Composite International Diagnostic Interview, version 3.0; onset of PTSD; and wartime experiences as measured by the Women's Wartime Exposure Scale-Revised. RESULTS: Among the 4219 women (48.3%) who completed the survey and a telephone interview, the weighted prevalence (95% CI) of lifetime PTSD was 20.1% (18.3%-21.8%), 11.5% (9.1%-13.9%), and 14.1% (12.4%-15.8%) for the Vietnam, near-Vietnam, and US cohorts, respectively. The weighted prevalence (95% CI) of current PTSD was 15.9% (14.3%-17.5%), 8.1% (6.0%-10.2%), and 9.1% (7.7%-10.5%) for the 3 cohorts, respectively. Few cases of PTSD among the Vietnam or near-Vietnam cohorts were attributable to premilitary onset (weighted prevalence, 2.9% [95% CI, 2.2%-3.7%] and 2.9% [95% CI, 1.7%-4.2%], respectively). Unadjusted models for lifetime and current PTSD indicated that women who served in Vietnam were more likely to meet PTSD criteria than women who mainly served in the United States (odds ratio [OR] for lifetime PTSD, 1.53 [95% CI, 1.28-1.83]; OR for current PTSD, 1.89 [95% CI, 1.53-2.33]). When we adjusted for wartime exposures, serving in Vietnam or near Vietnam did not increase the odds of having current PTSD (adjusted ORs, 1.05 [95% CI, 0.75-1.46] and 0.77 [95% CI, 0.52-1.14], respectively). CONCLUSIONS AND RELEVANCE: The prevalence of PTSD for the Vietnam cohort was higher than previously documented. Vietnam service significantly increased the odds of PTSD relative to US service; this effect appears to be associated with wartime exposures, especially sexual discrimination or harassment and job performance pressures. Results suggest long-lasting mental health effects of Vietnam-era service among women veterans.

Factors influencing admission among children with a traumatic brain injury.

OBJECTIVES: To describe the epidemiology of traumatic brain injury (TBI) among children in Maryland and to examine factors that influence hospital admission. METHODS: Statewide mortality, hospital discharge, and ambulatory care data were used to identify all TBI-related emergency department (ED) visits, hospitalizations, and deaths that occurred in 1998 to children aged 0-19 years according to the Centers for Disease Control and Prevention's standard case definition and protocol. Inpatient admission was modeled as a function of patient, injury, and hospital characteristics. RESULTS: The overall incidence of pediatric TBI (i.e., ED visits, hospitalizations, and deaths) in 1998 was 670/100,000. After controlling for injury severity and other factors, uninsured children were 40% less likely to be hospitalized (95% CI = 0.43 to 0.82) and children with Medicaid were 90% more likely to be hospitalized (95% CI = 1.42 to 2.54) than were those with private insurance. The presence of a major associated injury significantly influenced the likelihood of hospitalization, especially among children with a minor (OR = 8.8) to moderate (OR = 11.6) TBI. Children who presented to a trauma center hospital were significantly more likely to be hospitalized than children treated at a non-trauma center hospital, although this varied depending on income (OR = 1.8 for high versus low) and hospital volume (OR = 2.6 for a small hospital and OR = 29.0 for a large hospital). CONCLUSIONS: After adjusting for TBI severity and the presence of associated injuries, significant differences in hospitalization rates may exist among different patient subgroups and hospitals for children who sustain TBIs.

Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial.

AIMS: Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction. DESIGN: Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment. SETTING: The trial was conducted at eight medical centers in the United States. PARTICIPANTS: One hundred and forty methamphetamine-dependent adults took part in the trial. MEASUREMENTS: The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables. FINDINGS: In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated. CONCLUSIONS: Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent.

Analysis of Maryland poisoning deaths using classification and regression tree (CART) analysis.

Our study is a cross-sectional analysis of Maryland poisoning deaths for years 2003 and 2004. We used Classification and Regression Tree (CART) methodology to classify undetermined intent Maryland poisoning deaths as either unintentional or suicidal poisonings. The predictive ability of the selected set of variables (i.e., poisoned in the home or workplace, location type, where poisoned, place of death, poison type, victim race and age, year of death) was extremely good. Of the 301 test cases, only eight were misclassified by the CART regression tree. Of 1,204 undetermined intent poisoning deaths, CART classified 903 as suicides and 301 as unintentional deaths. The major strength of our study is the use of CART to differentiate with a high degree of accuracy between unintentional and suicidal poisoning deaths among Maryland undetermined intent poisoning deaths.

Validity of administrative data for characterizing traumatic brain injury-related hospitalizations.

PRIMARY OBJECTIVE: To examine the validity of Maryland Hospital Discharge (MHD) data for identifying and characterizing traumatic brain injury (TBI)-related hospitalizations. METHODS: All TBI-related hospitalizations in 1999 were identified using MHD and Maryland Trauma Registry (MTR) data. In addition, a sample of records were abstracted to compare agreement between MHD and chart data. RESULTS: The MHD file identified fewer TBI cases (61%) compared to the MTR (95%). Overall, TBI-related hospitalization rates based on MHD were significantly fewer (95; 95% CI 92, 98) vs MHD and MTR (144; 95% CI 140, 147). There was good agreement between the MHD and chart data regarding skull fractures or intracranial lesions (kappa = 0.73 and 0.83, respectively), but poor agreement for neurologic abnormalities or amnesia. The MHD significantly underestimated TBI severity. CONCLUSIONS: TBI cases, especially mild ones, were under-reported by MHD data. MHD data are better at detecting anatomic injuries compared to TBI symptoms and sequella.

Comparison of Maryland hospital discharge and trauma registry data.

BACKGROUND: This study aimed to examine the validity of using Maryland hospital discharge data to characterize injuries sustained by trauma patients. METHODS: Maryland hospital discharge and Maryland trauma registry data for 1999 were merged, and the extent of agreement regarding the presence and severity of injuries sustained was evaluated. RESULTS: The mean Injury Severity Score was 8.4 according to the Maryland hospital discharge data and 10 according to the Maryland trauma registry data (p < 0.0001). The Maryland hospital discharge data identified 95% or more of all moderate to severe injuries (Abbreviated Injury Score, > or =2) for all body regions except the head. There was substantial agreement between the two data sets for mechanism of injury (weighted kappa, 0.62), the number of preexisting conditions present (weighted kappa, 0.45) and final disposition (weighted kappa, 0.78). CONCLUSIONS: The Maryland hospital discharge data are a valid source for documenting the nature and severity of injuries sustained by trauma patients, except for those with a relatively minor head injury.