Feasibility of connecting regional research programs to national multisite trials emanating from the CTSA Trial Innovation Network.

A collaborative research model was developed and tested to enable regional healthcare systems to join multisite clinical trials emanating from the Clinical and Translational Science Award (CTSA) Trial Innovation Network (TIN) by the Institute of Translational Health Sciences at the University of Washington and the Northwest Participant and Clinical Interactions (NW PCI) Network. The NW PCI is a collaborative group of regional research programs located at medical centers, healthcare systems, and universities across Washington, Wyoming, Alaska, Montana, and Idaho. This article describes the purpose, development, barriers, and initial experience with feasibility assessment for TIN-supported studies in the NW PCI. The tools and processes of the NW PCI Network were adapted to enable network sites to assess studies for clinical relevance and feasibility. Seven of seventeen TIN-supported studies were reviewed for consideration; three of which resulted in successful completion of study documentation for site selection by NW PCI sites. The NW PCI/TIN model can be adapted by other CTSAs to increase involvement of regional research programs in national multisite clinical research studies. Barriers to expanding TIN-supported trials to regional networks include short timelines for study document submissions, insufficient site reimbursement rates, and non-feasible study designs.

Delay in Treatment After Cancer Diagnosis in Adolescents and Young Adults: Does Facility Transfer Matter?

Background: Timeliness is one of the fundamental yet understudied quality metrics of cancer care. Little is known about cancer treatment delay among adolescent and young adult (AYA) cancer patients. This study assessed cancer treatment delay, with a specific focus on facility transfer and diagnosis/treatment interval. Methods: Based on MultiCare Health System's (MHS's) institutional cancer registry data of AYA patients diagnosed during 2006-2015, this study analyzed patient demographics, insurance, clinical characteristics, and time of diagnosis and treatment initiation. Chi-squared tests, cumulative hazard estimates, and Cox proportional regression were used for univariable analysis. Multivariate regression models were used to test the association between care transfer and days of interval or prolonged delay, controlling for baseline parameters. Results: Of 840 analytic AYA cases identified, 457 (54.5%) were both diagnosed and treated within MHS. A total of 45.5% were either diagnosed or treated elsewhere. Mean and median intervals for treatment initiation were 27.03 (95% CI = 21.94-33.14) and 8.00 days (95% CI = 5.00-11.00), respectively, with significant differences between patients with and without facility transfer. Transfer was significantly correlated with longer length of diagnosis-to-treatment interval. Treatment delay, ≥1 week, was associated with transfer, female sex, older age, no surgery involvement, and more treatment modalities. Treatment delay, ≥4 weeks, was associated with transfer, female sex, no insurance, and no surgery involvement. Conclusion: In a community care setting, the diagnosis-to-treatment interval is significantly longer for transferred AYA cancer patients than for patients without a transfer. Future studies are warranted to explore the prognostic implications and the reasons for delays within specific cancer types.

The discriminative power of STOP-Bang as a screening tool for suspected obstructive sleep apnea in clinically referred patients: considering gender differences.

PURPOSE: Obstructive sleep apnea (OSA) is the most commonly seen clinical sleep disorder. STOP-Bang, a widely used screening tool, yields a composite score based on eight dichotomized items including male gender. This study was designed to validate STOP-Bang among clinically referred patients and tested alternative scoring designs on tool performance, with a focus on gender differences in OSA. METHOD: STOP-Bang was administered to 403 female and 532 male subjects, followed by comprehensive sleep evaluation that included measurement of apnea-hypopnea indexes. Gender differences in STOP-Bang scores, OSA diagnosis, and severities were explored, and gender-specific alternative score cutoffs evaluated. Optimal operating points (OOP) were tested for female body mass index (BMI) and male neck circumference to inform STOP-Bang threshold refinement. Receiver operating characteristic curves were used to compare conventional and modified STOP-Bang. RESULTS: STOP-Bang performance by gender showed extremely low specificity in males at the recommended cutoff of ≥3. Better utility was presented at a cutoff of 4 or 5 among clinically referred patients irrespective of gender differences. Screening performance was improved by modifying BMI and/or neck circumference thresholds using gender-triaged OOP estimation. Three gender-based model revisions outperformed conventional STOP-Bang. CONCLUSION: Our study suggests that gender-specific consideration needs to be incorporated into the application of STOP-Bang in a clinically referred patient population with a higher risk of OSA. Alternative scoring systems may improve predictive performance of STOP-Bang.

Functional electrical stimulation improves quality of life by reducing intermittent claudication.

OBJECTIVE: To determine if Functional Electrical Stimulation (FES) would improve ischemic pain, walking distance, and quality of life of patients with intermittent claudication. DESIGN: Single blind, randomized block, two factorial design. PATIENTS: Patients diagnosed with Peripheral Artery Disease (PAD) and intermittent claudication (IC). Ankle Brachial Index ranged 0.4-0.9 on at least one leg. Patients were randomly assigned to experimental (FES+Walk, N=13) or control (WALK, N=14) groups. INTERVENTION: Experimental group patients received FES to the dorsiflexor and plantarflexor muscles while walking for 1h/day, six days/week for eight weeks. Control group patients received similar intervention without FES. A Follow-up period of both groups lasted eight weeks. OUTCOME MEASURES: Outcome measures were taken at baseline (T0), after intervention (T1), and after follow-up (T2). Primary measures included Perceived Pain Intensity (PPI), Six minute walk (6MW), and Peripheral Arterial Disease Quality of Life (PADQOL). Secondary measures included Intermittent Claudication Questionnaire (ICQ) and Timed Up and Go (TUG). RESULTS: Group by time interactions in PPI were significant (P<0.001) with differences of 27.9 points at T1 and 36.9 points at T2 favoring the FES+Walk group. Groups difference in Symptoms and Limitations in Physical Function of the PADQOL reached significance (T1=8.9, and T2=8.3 improvements; P=0.007). ICQ was significant (T1=9.3 and T2=13.1 improvements; P=0.003). Improvement in 6MW and TUG tests were similar between groups. CONCLUSIONS AND RELEVANCE: Walking with FES markedly reduced ischemic pain and enhanced QOL compared to just walking. FES while walking may offer an effective treatment option for the elderly with PAD and Intermittent Claudication. TRIAL REGISTRATION: NIH-NIA 1R21AG048001 https://projectreporter.nih.gov/project_info_description.cfm?aid=8748641&icde=30695377&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC. https://clinicaltrials.gov/ct2/show/NCT02384980?term=David+Embrey&rank=1.

Assessment of clinical trial participant patient satisfaction: a call to action.

BACKGROUND: As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. METHODS: We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. RESULTS: Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p < 0.0001). Reasons cited for clinical trial enrollment were generally altruistic. CONCLUSIONS: Querying this special patient population is feasible and yields valuable insight into their experience with healthcare system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

Development of a systematic protocol to identify victims of non-accidental trauma.

PURPOSE: Each year, nearly 1 million children in the USA are victims of non-accidental trauma (NAT). Missed diagnosis or poor case management often leads to repeat/escalation injury. Victims of recurrent NAT are at higher risk for severe morbidity and mortality resulting from abuse. The objective of this review is to describe the evolution and implementation of this tool and evaluate our institutional response to NAT prior to implementation. METHODS: A systematic guideline for the evaluation of pediatric patients in which NAT is suspected or confirmed was developed and implemented at a level II pediatric trauma hospital. To understand the state of our institution prior to implementation of the guideline, a review of 117 confirmed NAT cases at our hospital over the prior 4 years was conducted. RESULTS: In the absence of a systematic management guideline, important and relevant social and family history red flags were often missing in the initial evaluation. Patients with perineal bruising experienced significantly higher mortality than patients without perineal bruising (27.3 vs. 5.7%; p = 0.03) and were significantly more likely to require surgery (45.5 vs. 14.2%; p = 0.02). CONCLUSION: Development and implementation of a standardized tool for the differentiation and diagnosis of NAT and creation of a structured electronic medical record note should improve the description and documentation of child abuse cases in a community hospital setting. A retrospective analysis demonstrated that in the absence of such a tool, management of NAT may be inconsistent or incomplete. Perineal injury is an especially ominous red flag finding.

Quality improvement measures in pulse-oximetry newborn heart screening: a time series analysis.

BACKGROUND AND OBJECTIVES: The use of pulse-oximetry screening to detect critical congenital heart defects in newborns has gained national and international momentum in the past decade. Our hospital system began screening in 2008. Since then, our program has undergone leadership changes and multiple quality improvement interventions. The aims of this study are to evaluate the evolution of our pulse-oximetry program and to provide insights from lessons learned over the course of a long-standing program. METHODS: We reviewed 6 years of screening data and evaluated trends of missed screens, false-positives, protocol violations, and parental decline of screening. We implemented 3 quality improvement interventions (change in protocol, redesign of an electronic medical record documentation system to autocalculate results, and transition from research to standard-of-care) and reviewed the impact of a rigorous quality assurance review process. We used linear regression and statistical process control charts to evaluate the data. RESULTS: A total of 18,363 newborns were screened; we identified 5 critical cases. We observed a significant decrease in missed (P < .001) and false-positive (P = .03) screens over time but found no significant trend in the rate of percentage of protocol violations (P = .26) or decline of screening (P = .99). Each metric showed behavior attributable to at least 1 quality improvement intervention. CONCLUSIONS: We established a sustainable pulse-oximetry screening program in our community hospital system, and the screening has now become routine. The quality of our screening was influenced by choice of screening protocol, rigor of quality assurance reviews, and the process used to interpret screening results.

Fructose intolerance/malabsorption and recurrent abdominal pain in children.

OBJECTIVES: The purpose of the present study was to ascertain whether pediatric patients with chronic abdominal pain had concurrent fructose intolerance as determined by a standardized dose breath hydrogen test (BHT), and whether symptoms would improve with a low-fructose diet. METHODS: The fructose BHT test was administered to patients evaluated in clinic with unexplained chronic abdominal pain alone or associated with constipation, gas or bloating, and/or diarrhea. The patients were given a standard dose of 1 g/kg fructose to maximum of 25 g. Hydrogen and methane were measured at 8 time points. The test was presumed positive if breath hydrogen exceeded 20 ppm above baseline. If positive, patients were given a dietitian-prescribed low-fructose diet. RESULTS: A total of 222 patients were part of the study. Ages ranged from 2 to 19 years with a mean of 10.5. BHT for fructose was performed in all of the patients and it was positive for fructose intolerance in 121 of 222 patients (54.5%). A total of 101 of 222 (45.5%) patients had negative BHT for fructose intolerance. All BHT-positive patients had a nutrition consult with a registered dietitian and were placed on a low-fructose diet. Using a standard pain scale for children, 93 of 121 patients (76.9%) reported resolution of symptoms on a low-fructose diet (P < 0.0001). Furthermore, 55 of 101 patients (54.4%) with negative BHT for fructose reported resolution of symptoms without a low-fructose diet (P = 0.37). CONCLUSIONS: Fructose intolerance/malabsorption is common in children with recurrent/functional abdominal pain and a low-fructose diet is an effective treatment.

Disability among US Army Veterans vaccinated against anthrax.

CONTEXT: To protect troops against the use of anthrax as a biological weapon, the US Department of Defense began an anthrax vaccination program in 1998. 14 years after the inception of the vaccination program, there is no evidence suggesting vaccination against anthrax carries long-term health risks for Active Duty Soldiers. OBJECTIVE: To investigate the association between Anthrax Vaccine Adsorbed (AVA) received while on Active Duty and subsequent disability determined by the Veterans Benefits Administration. DESIGN, SETTING AND PARTICIPANTS: Case-control study nested in the cohort of all Active Duty personnel known to have separated from the US Army between December 1, 1997 and December 31, 2005. Cases were ≥10% disabled, determined either by the Army prior to separation (N=5846) or by the Veterans Benefits Administration (VBA) after separation (N=148,934). Controls (N=937,705) separated from the Army without disability, and were not receiving pensions from the VBA as of April 2007. Data were from the Total Army Injury and Health Outcomes Database and the VBA Compensation and Pension and Benefits database. MAIN OUTCOMES: Disability status (yes/no); for primary disability, percent disabled (≥10%, 20%, >20%) and type of disability. RESULTS: Vaccination against anthrax was four times more likely among disabled Veterans with hostile fire pay records (HFP, a surrogate for deployment). Vaccinated Soldiers with HFP had lower odds of disability separation from the Army 0.89 (0.80, 0.98); there was no association between vaccine and receiving Army disability benefits among those without HFP (OR=1.05, CI: 0.96, 1.14). Vaccination was negatively associated with receiving VA disability benefits for those with HFP (OR=0.66, CI: 0.65, 0.67), but there was little or no association between vaccine and receipt of VA disability benefits for those without HFP (OR=0.95, CI: 0.93, 0.97). CONCLUSIONS: Risk of disability separation from the Army and receipt of disability compensation from the VA were not increased in association with prior exposure to AVA. This study provides evidence that vaccination against anthrax is not associated with long term disability.

Application of latent semantic analysis for open-ended responses in a large, epidemiologic study.

BACKGROUND: The Millennium Cohort Study is a longitudinal cohort study designed in the late 1990s to evaluate how military service may affect long-term health. The purpose of this investigation was to examine characteristics of Millennium Cohort Study participants who responded to the open-ended question, and to identify and investigate the most commonly reported areas of concern. METHODS: Participants who responded during the 2001-2003 and 2004-2006 questionnaire cycles were included in this study (n = 108,129). To perform these analyses, Latent Semantic Analysis (LSA) was applied to a broad open-ended question asking the participant if there were any additional health concerns. Multivariable logistic regression was performed to examine the adjusted odds of responding to the open-text field, and cluster analysis was executed to understand the major areas of concern for participants providing open-ended responses. RESULTS: Participants who provided information in the open-ended text field (n = 27,916), had significantly lower self-reported general health compared with those who did not provide information in the open-ended text field. The bulk of responses concerned a finite number of topics, most notably illness/injury, exposure, and exercise. CONCLUSION: These findings suggest generalized topic areas, as well as identify subgroups who are more likely to provide additional information in their response that may add insight into future epidemiologic and military research.

Risk of disability for US army personnel vaccinated against anthrax, 1998-2005.

To evaluate the potential for long-term or delayed onset health effects, we extended a previous cohort study of disability separation from the army associated with vaccination against anthrax. Analyses included stratified Cox proportional hazards and multiple logistic regression models. Forty-one percent of 1,001,546 soldiers received at least one anthrax vaccination; 5.21% were evaluated for disability. No consistent patterns or statistically significant differences in risk of disability evaluation, disability determination, or reason for disability were associated with anthrax vaccination. There was a dose-related trend in risk of disability for soldiers with 2 years' service, limited to those entering service in 2000 or later. Divergent patterns in risk suggest confounding by temporal or occupational risks of disability.

Preinjury psychiatric status, injury severity, and postdeployment posttraumatic stress disorder.

CONTEXT: Physical injury has been associated with the development of posttraumatic stress disorder (PTSD). Previous studies have retrospectively examined the relationship of preinjury psychiatric status and postinjury PTSD with conflicting results, but no prospective studies regarding this subject have been conducted, to our knowledge. OBJECTIVE: To prospectively assess the relationship of predeployment psychiatric status and injury severity with postdeployment PTSD. DESIGN: Prospective, longitudinal study. SETTING: United States military personnel deployed in support of the conflicts in Iraq and Afghanistan. PARTICIPANTS: United States service member participants in the Millennium Cohort Study who completed a baseline questionnaire (from July 1, 2001, through June 30, 2003) and at least 1 follow-up questionnaire (from June 1, 2004, through February 14, 2006, and from May 15, 2007, through December 31, 2008) and who were deployed in the intervening period. Self-reported health information was used to prospectively examine the relationship between baseline psychiatric status and follow-up PTSD in injured and uninjured deployed individuals. MAIN OUTCOME MEASURES: A positive screening result using the PTSD Checklist-Civilian Version. RESULTS: Of 22 630 eligible participants, 1840 (8.1%) screened positive for PTSD at follow-up, and 183 (0.8%) sustained a deployment-related physical injury that was documented in the Joint Theater Trauma Registry or the Navy-Marine Corps Combat Trauma Registry Expeditionary Medical Encounter Database. The odds of screening positive for PTSD symptoms were 2.52 (95% confidence interval, 2.01-3.16) times greater in those with 1 or more defined baseline mental health disorder and 16.1% (odds ratio, 1.16; 95% confidence interval, 1.01-1.34) greater for every 3-unit increase in the Injury Severity Score. Irrespective of injury severity, self-reported preinjury psychiatric status was significantly associated with PTSD at follow-up. CONCLUSIONS: Baseline psychiatric status and deployment-related physical injuries were associated with screening positive for postdeployment PTSD. More vulnerable members of the deployed population might be identified and benefit from interventions targeted to prevent or to ensure early identification and treatment of postdeployment PTSD.

Health impact of US military service in a large population-based military cohort: findings of the Millennium Cohort Study, 2001-2008.

BACKGROUND: Combat-intense, lengthy, and multiple deployments in Iraq and Afghanistan have characterized the new millennium. The US military's all-volunteer force has never been better trained and technologically equipped to engage enemy combatants in multiple theaters of operations. Nonetheless, concerns over potential lasting effects of deployment on long-term health continue to mount and are yet to be elucidated. This report outlines how findings from the first 7 years of the Millennium Cohort Study have helped to address health concerns related to military service including deployments. METHODS: The Millennium Cohort Study was designed in the late 1990s to address veteran and public concerns for the first time using prospectively collected health and behavioral data. RESULTS: Over 150,000 active-duty, reserve, and National Guard personnel from all service branches have enrolled, and more than 70% of the first 2 enrollment panels submitted at least 1 follow-up survey. Approximately half of the Cohort has deployed in support of operations in Iraq and Afghanistan. CONCLUSION: The Millennium Cohort Study is providing prospective data that will guide public health policymakers for years to come by exploring associations between military exposures and important health outcomes. Strategic studies aim to identify, reduce, and prevent adverse health outcomes that may be associated with military service, including those related to deployment.

Effectiveness of an external ankle brace in reducing parachuting-related ankle injuries.

Outside-the-boot parachute ankle braces (PABs) worn during US Army paratrooper training have been shown to reduce the risk of severe ankle injuries. In spite of evidence to the contrary, anecdotal reports continue to suggest increases in risk of other types of injury, and the cost of obtaining and periodically replacing the PAB has been used to justify its discontinued use. The authors identified inpatient and outpatient treatment for injuries during US Army paratrooper training. Those undergoing training during two periods when PAB use was mandated had 40% lower risks of ankle injury (brace I, RR=0.60 (95% CI 0.47 to 0.75); brace II, RR=0.62 (95% CI 0.49 to 0.78)), with no difference in risks of other types of injury. There were no differences in risk of ankle injury during periods when brace use was not mandated. The PAB is safe, effective and cost effective.

Assessing nonresponse bias at follow-up in a large prospective cohort of relatively young and mobile military service members.

BACKGROUND: Nonresponse bias in a longitudinal study could affect the magnitude and direction of measures of association. We identified sociodemographic, behavioral, military, and health-related predictors of response to the first follow-up questionnaire in a large military cohort and assessed the extent to which nonresponse biased measures of association. METHODS: Data are from the baseline and first follow-up survey of the Millennium Cohort Study. Seventy-six thousand, seven hundred and seventy-five eligible individuals completed the baseline survey and were presumed alive at the time of follow-up; of these, 54,960 (71.6%) completed the first follow-up survey. Logistic regression models were used to calculate inverse probability weights using propensity scores. RESULTS: Characteristics associated with a greater probability of response included female gender, older age, higher education level, officer rank, active-duty status, and a self-reported history of military exposures. Ever smokers, those with a history of chronic alcohol consumption or a major depressive disorder, and those separated from the military at follow-up had a lower probability of response. Nonresponse to the follow-up questionnaire did not result in appreciable bias; bias was greatest in subgroups with small numbers. CONCLUSIONS: These findings suggest that prospective analyses from this cohort are not substantially biased by non-response at the first follow-up assessment.

Prior health care utilization patterns and suicide among U.S. Army soldiers.

Suicides among U.S. Army soldiers are increasing and, in January 2009, outpaced deaths due to combat. For this study, 1,873 army suicides identified through death, inpatient, and emergency room records were matched with 5,619 controls. In multivariate models, older, male, White, single, and enlisted soldiers with a prior injury (OR = 2.04, 95% CI = 1.64-2.54), alcohol (OR = 3.41, 95% CI = 2.32-4.99), or mental health hospitalization (OR = 6.62, 95% CI = 4.77-9.20) were at increased risk for suicide. Risk was greatest immediately following diagnoses, but remained elevated even after 5 or more years of follow-up. Most injury hospitalizations were unintentional but, nonetheless, significantly associated with suicide. Interactions indicate soldiers with both mental health and injury history are particularly vulnerable.

Risk of diabetes in U.S. military service members in relation to combat deployment and mental health.

OBJECTIVE: Few prospective data exist on the risk of diabetes in individuals serving in the U.S. military. The objectives of this study were to determine whether military deployment, combat exposures, and mental health conditions were related to the risk of newly reported diabetes over 3 years. RESEARCH DESIGN AND METHODS: Data were from Millennium Cohort Study participants who completed baseline (July 2001-June 2003) and follow-up (June 2004-February 2006) questionnaires (follow-up response rate = 71.4%). After exclusion criteria were applied, adjusted analyses included 44,754 participants (median age 36 years, range 18-68 years). Survey instruments collected demographics, height, weight, lifestyle, military service, clinician-diagnosed diabetes, and other physical and mental health conditions. Deployment was defined by U.S. Department of Defense databases, and combat exposure was assessed by self-report at follow-up. Odds of newly reported diabetes were estimated using logistic regression analysis. RESULTS: Occurrence of diabetes during follow-up was 3 per 1,000 person-years. Individuals reporting diabetes at follow-up were significantly older, had greater baseline BMI, and were less likely to be Caucasian. After adjustment for age, sex, BMI, education, race/ethnicity, military service characteristics, and mental health conditions, only baseline posttraumatic stress disorder (PTSD) was significantly associated with risk of diabetes (odds ratio 2.07 [95% CI 1.31-3.29]). Deployments since September 2001 were not significantly related to higher diabetes risk, with or without combat exposure. CONCLUSIONS: In this military cohort, PTSD symptoms at baseline but not other mental health symptoms or military deployment experience were significantly associated with future risk of self-reported diabetes.

Demographic, physical, and mental health factors associated with deployment of U.S. Army soldiers to the Persian Gulf.

A total of 675,626 active duty Army soldiers who were known to be at risk for deployment to the Persian Gulf were followed from 1980 through the Persian Gulf War. Hospitalization histories for the entire cohort and Health Risk Appraisal surveys for a subset of 374 soldiers were used to evaluate prewar distress, health, and behaviors. Deployers were less likely to have had any prewar hospitalizations or hospitalization for a condition commonly reported among Gulf War veterans or to report experiences of depression/suicidal ideation. Deployers reported greater satisfaction with life and relationships but displayed greater tendencies toward risk taking, such as drunk driving, speeding, and failure to wear safety belts. Deployed veterans were more likely to receive hazardous duty pay and to be hospitalized for an injury than nondeployed Gulf War-era veterans. If distress is a predictor of postwar morbidity, it is likely attributable to experiences occurring during or after the war and not related to prewar exposures or health status. Postwar excess injury risk may be explained in part by a propensity for greater risk taking, which was evident before and persisted throughout the war.

Early mortality experience in a large military cohort and a comparison of mortality data sources.

BACKGROUND: Complete and accurate ascertainment of mortality is critically important in any longitudinal study. Tracking of mortality is particularly essential among US military members because of unique occupational exposures (e.g., worldwide deployments as well as combat experiences). Our study objectives were to describe the early mortality experience of Panel 1 of the Millennium Cohort, consisting of participants in a 21-year prospective study of US military service members, and to assess data sources used to ascertain mortality. METHODS: A population-based random sample (n = 256,400) of all US military service members on service rosters as of October 1, 2000, was selected for study recruitment. Among this original sample, 214,388 had valid mailing addresses, were not in the pilot study, and comprised the group referred to in this study as the invited sample. Panel 1 participants were enrolled from 2001 to 2003, represented all armed service branches, and included active-duty, Reserve, and National Guard members. Crude death rates, as well as age- and sex-adjusted overall and age-adjusted, category-specific death rates were calculated and compared for participants (n = 77,047) and non-participants (n = 137,341) based on data from the Social Security Administration Death Master File, Department of Veterans Affairs (VA) files, and the Department of Defense Medical Mortality Registry, 2001-2006. Numbers of deaths identified by these three data sources, as well as the National Death Index, were compared for 2001-2004. RESULTS: There were 341 deaths among the participants for a crude death rate of 80.7 per 100,000 person-years (95% confidence interval [CI]: 72.2,89.3) compared to 820 deaths and a crude death rate of 113.2 per 100,000 person-years (95% CI: 105.4, 120.9) for non-participants. Age-adjusted, category-specific death rates highlighted consistently higher rates among study non-participants. Although there were advantages and disadvantages for each data source, the VA mortality files identified the largest number of deaths (97%). CONCLUSIONS: The difference in crude and adjusted death rates between Panel 1 participants and non-participants may reflect healthier segments of the military having the opportunity and choosing to participate. In our study population, mortality information was best captured using multiple data sources.