Veterans Affairs Cooperative Studies Program Study #553: Chemotherapy After Prostatectomy for High-risk Prostate Carcinoma: A Phase III Randomized Study.

BACKGROUND: The Veterans Affairs Cooperative Studies Program study #553 was designed to evaluate the efficacy of adjuvant chemotherapy added to the standard of care (SOC) for patients who are at high risk for relapse after prostatectomy. OBJECTIVE: To test whether addition of chemotherapy to surgery for high-risk prostate cancer improves progression-free survival (PFS). DESIGN, SETTING, AND PARTICIPANTS: Eligible patients after prostatectomy were randomized to the SOC group with observation or to the chemotherapy group with docetaxel and prednisone administered every 3 wk for six cycles. Randomization was stratified for prostate-specific antigen, Gleason, tumor stage, and surgical margin status. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was PFS. Secondary endpoints included overall, prostate cancer-specific, and metastasis-free survival, and time to androgen deprivation therapy. RESULTS AND LIMITATIONS: A total of 298 of the planned 636 patients were randomized. The median follow-up was 59.1 mo (0.2-103.7 mo). For the primary endpoint, the two groups did not statistically differ in PFS (median 55.5 mo in the chemotherapy group and 42.2 mo in the SOC group; test adjusted for site via gamma frailty p=0.21; adjusted hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.58-1.11; p=0.18). Prespecified subgroup analyses showed benefit in PFS for patients with tumor stage ≥T3b (HR 0.54, 95% CI 0.32-0.92; p=0.022) and patients with Gleason score ≤7 (HR 0.65, 95% CI 0.43-0.99; p=0.046). Secondary endpoint analyses are hampered by low event rates. The most common adverse events (≥grade 3 related or possibly related to chemotherapy) included neutropenia (43%), hyperglycemia (20%), and fatigue (5%), with febrile neutropenia in 2%. CONCLUSIONS: Adjuvant chemotherapy in high-risk prostate cancer using docetaxel and prednisone did not lead to statistically significant improvement in PFS for the intention-to-treat population as a whole. The analysis was challenged by lower power due to accrual limitation. Subgroup analyses suggest potential benefit for patients with Gleason grade ≤7 and stage≥pT3b (ClinicalTrials.gov number NCT00132301). PATIENT SUMMARY: In this randomized trial, we tested whether addition of chemotherapy to surgery for high-risk prostate cancer decreased the risk of prostate-specific antigen rise after surgery. We found no benefit from docetaxel given after radical prostatectomy, although some subgroups of patients may benefit.

Trends in diagnosis of painful neck and back conditions, 2002 to 2011.

Neck and back pain are pervasive problems. Some have suggested that rising incidence may be associated with the evidence of rising prevalence.To describe the trends in diagnosis of painful neck and back conditions in a large national healthcare system.A retrospective observational cohort study to describe the incidence and prevalence of diagnosis of neck and back pain in a national cohort.Patients were identified by International Classification of Diseases, 9 Revision (ICD-9) codes in Department of Veterans Affairs (VA) national utilization datasets in calendar years 2002 to 2011.Descriptive statistics were used to analyze the data. Prevalent cases were compared with all veterans who sought health care in each year. Incident cases were identified following a 2 years clean period in which the patient was enrolled and received care, but not services for any back or neck pain conditions.From 2004 to 2011, 3% to 4% of the population was diagnosed with incident back pain problems, the rate increasing on average, 1.75% per year. During the same period, 12.3% to 16.2% of the population was diagnosed with a prevalent back pain problem, the rate increasing on average 4.09% per year.In a national population, the prevalence rate for diagnosis of neck and back pain grew 1.8 to 2.3 times faster than the incidence rate. This suggests that the average duration of episodes of care is increasing. Additional research is needed to understand the influences on the differential rate of change and to develop efficient and effective care systems.

Evaluating Two Measures of Lumbar Spine MRI Overuse: Administrative Data Versus Chart Review.

PURPOSE: Lumbar spine (LS) MRI overuse may be identified in administrative data, but these data may lack the detailed clinical information needed to correctly assess overuse. The aim of this study was to compare chart review with analysis of administrative data to determine the appropriateness of LS MRI. METHODS: The sensitivity and specificity of the administrative method were determined, with inappropriateness regarded as the positive result, as if chart review determined the true state. Patients were the first 146 veterans who underwent LS MRI in the outpatient setting in fiscal year 2012 at the Veterans Affairs Palo Alto Health Care System. The InterQual criteria for chart review and the method of evaluating administrative data developed by CMS and endorsed by the National Quality Forum were used. Slight modifications were made to each measure to ensure completeness and comparability. RESULTS: Of the 146 scans reviewed, 23% were considered inappropriate by the administrative measure, whereas 59% were considered inappropriate by chart review. Compared with chart review, the administrative measure had specificity of 82% for identifying inappropriate scans and sensitivity of 27% for identifying appropriate scans. CONCLUSIONS: Compared with chart review, analysis of administrative data identified scans that were appropriate but underestimated inappropriate ordering. Contrary to expectations, chart review resulted in more scans being classified as inappropriate. The administrative method is economically feasible for identifying the overuse of LS MRI, but it underestimates the true extent of inappropriate ordering.

Inappropriate ordering of lumbar spine magnetic resonance imaging: are providers Choosing Wisely?

OBJECTIVES: To analyze inappropriate use of magnetic resonance imaging (MRI) for patients with low back pain in a healthcare system with no financial incentives for overuse. STUDY DESIGN: We used administrative data to assess the appropriateness of lumbar spine (LS) MRI in the Veterans Health Administration. METHODS: All veterans who received LS MRI in the outpatient setting in fiscal year 2012 were included. We based our assessments of appropriateness on CMS criteria, which have been endorsed by the National Quality Forum. Generalized estimating equations were used to evaluate characteristics of inappropriate scans. RESULTS: Of the 110,661 LS MRIs performed, 31% were classified as inappropriate. Most scans that were considered appropriate were characterized as such because they were preceded by conservative therapy (53%). "Red flag" conditions were responsible for a much smaller percentage of scans being considered appropriate; 13% of scans were preceded by conservative therapy and were performed in patients with a red flag condition, while only 4% of scans were considered appropriate because of red flag conditions only. Scans ordered in the emergency department and in urgent care, primary care, and internal medicine clinics were most likely to be classified as inappropriate. Resident physicians were significantly less likely than other provider types to order inappropriate LS MRIs (odds ratio, 0.80; P < .0001). Approximately 24% of providers ordered 74% of inappropriate scans. CONCLUSIONS: We found that 31% of LS MRIs were inappropriate in a healthcare system largely absent of financial and other incentives for ordering. The problem of inappropriate ordering of LS MRI is concentrated in a small number of providers; any provider-facing interventions to reduce inappropriate order should therefore be targeted, rather than aimed at all providers who order LS MRI.

Workforce Projections 2010-2020: Annual Supply and Demand Forecasting Models for Physical Therapists Across the United States.

BACKGROUND: Health human resources continue to emerge as a critical health policy issue across the United States. OBJECTIVE: The purpose of this study was to develop a strategy for modeling future workforce projections to serve as a basis for analyzing annual supply of and demand for physical therapists across the United States into 2020. DESIGN: A traditional stock-and-flow methodology or model was developed and populated with publicly available data to produce estimates of supply and demand for physical therapists by 2020. METHODS: Supply was determined by adding the estimated number of physical therapists and the approximation of new graduates to the number of physical therapists who immigrated, minus US graduates who never passed the licensure examination, and an estimated attrition rate in any given year. Demand was determined by using projected US population with health care insurance multiplied by a demand ratio in any given year. The difference between projected supply and demand represented a shortage or surplus of physical therapists. RESULTS: Three separate projection models were developed based on best available data in the years 2011, 2012, and 2013, respectively. Based on these projections, demand for physical therapists in the United States outstrips supply under most assumptions. LIMITATIONS: Workforce projection methodology research is based on assumptions using imperfect data; therefore, the results must be interpreted in terms of overall trends rather than as precise actuarial data-generated absolute numbers from specified forecasting. CONCLUSIONS: Outcomes of this projection study provide a foundation for discussion and debate regarding the most effective and efficient ways to influence supply-side variables so as to position physical therapists to meet current and future population demand. Attrition rates or permanent exits out of the profession can have important supply-side effects and appear to have an effect on predicting future shortage or surplus of physical therapists.

Using lean management to reduce blood culture contamination.

BACKGROUND: Blood culture contamination (BCC) is a common and avoidable complication of patient care and incurs considerable cost. A quality improvement (QI) initiative was undertaken at a large Department of Veterans Affairs (VA) medical center to reduce the BCC rate. METHODS: Lean management QI methods, including a rapid process improvement workshop (RPIW), were used to identify root causes of variation in blood culture procedures and countermeasures (potential improvement strategies) to address each problem were developed. BCC rates were collected for five and one quarter years, including the pre-RPIW (baseline) period, and changes in the contamination rates were calculated. The observed change in BCC rates was compared to a forecast of the pre-RPIW trend and estimated BCCs avoided. Results for the primary medical center were compared with those of a similarly complex VA medical center during the same time periods using difference-in-differences methodology. RESULTS: Qualitative assessment of the processes of care identified four root cause problems, each of which was addressed with countermeasures. The BCC rate at the primary medical center decreased significantly from the baseline period in each year of follow-up, improving from 4.2% in the 19-month baseline period to 2.8% in the last 12 months of follow-up (April 2013-March 2014), while changes from baseline in the BCC rate at the comparison site were significant in only one year of follow-up. An estimated 261 BCCs were avoided at the primary medical center in the follow-up period. CONCLUSION: The QI initiative was successful in reducing BCC rates and in producing continued improvement for nearly four years of follow-up. Further study will determine if these results are generalizable to other settings.

Cost-effectiveness of supported employment for veterans with spinal cord injuries.

OBJECTIVE: To estimate the cost-effectiveness of a supported employment (SE) intervention that had been previously found effective in veterans with spinal cord injuries (SCIs). DESIGN: Cost-effectiveness analysis, using cost and quality-of-life data gathered in a trial of SE for veterans with SCI. SETTING: SCI centers in the Veterans Health Administration. PARTICIPANTS: Subjects (N=157) who completed a study of SE in 6 SCI centers. Subjects were randomly assigned to the intervention of SE (n=81) or treatment as usual (n=76). INTERVENTION: A vocational rehabilitation program of SE for veterans with SCI. MAIN OUTCOME MEASURES: Costs and quality-adjusted life years, which were estimated from the Veterans Rand 36-Item Health Survey, extrapolated to Veterans Rand 6 Dimension utilities. RESULTS: Average cost for the SE intervention was $1821. In 1 year of follow-up, estimated total costs, including health care utilization and travel expenses, and average quality-adjusted life years were not significantly different between groups, suggesting the Spinal Cord Injury Vocational Integration Program intervention was not cost-effective compared with usual care. CONCLUSIONS: An intensive program of SE for veterans with SCI, which is more effective in achieving competitive employment, is not cost-effective after 1 year of follow-up. Longer follow-up and a larger study sample will be necessary to determine whether SE yields benefits and is cost-effective in the long run for a population with SCI.

Racial differences in veterans' satisfaction with examination of disability from posttraumatic stress disorder.

OBJECTIVE: The examination that determines if a veteran has service-connected posttraumatic stress disorder (PTSD) affects veterans' lives for years. This study examined factors potentially associated with veterans' perception of their examination's quality. METHODS: Veterans (N=384) being evaluated for an initial PTSD service-connection claim were randomly assigned to receive either a semistructured interview or the examiner's usual interview. Immediately after the interview, veterans completed confidential ratings of the examinations' quality and of their examiners' interpersonal qualities and competence. Extensive data characterizing the veterans, the 33 participating examiners, and the examinations themselves were collected. RESULTS: Forty-seven percent of Caucasian veterans and 34% of African-American veterans rated their examination quality as excellent. African Americans were less likely than Caucasians to assign a higher quality rating (odds ratio=.61, 95% confidence interval=.38-.99, p=.047). Compared with Caucasians, African Americans rated their examiners as having significantly worse interpersonal qualities but not lower competence. Ratings were not significantly related to the veterans' age, gender, marital status, eventual diagnosis of PTSD, Global Assessment of Functioning score, the examiner's perception of the prevalence of malingering, or the presence of a third party during the examination. CONCLUSIONS: Ratings of disability examinations were generally high, although ratings were less favorable among African-American veterans than among Caucasian veterans.

Impact of evidence-based standardized assessment on the disability clinical interview for diagnosis of service-connected PTSD: a cluster-randomized trial.

Posttraumatic stress disorder (PTSD) is one of the fastest growing compensated medical conditions. The present study compared usual disability examiner practices for PTSD with a standardized assessment that incorporates evidence-based assessments. The design was a multicenter, cluster randomized, parallel-group study involving 33 clinical examiners and 384 veterans at 6 Veterans Affairs medical centers. The standardized group incorporated the Clinician Administered PTSD Scale and the World Health Organization Disability Assessment Schedule-II into their assessment interview. The main outcome measures were completeness and accuracy of PTSD diagnosis and completeness of functional assessment. The standardized assessments were 85% complete for diagnosis compared to 30% for nonstandardized assessments (p < .001), and, for functional impairment, 76% versus 3% (p < .001). The findings demonstrate that the quality of PTSD disability examination would be improved by using evidence-based assessment.

Effectiveness of supported employment for veterans with spinal cord injuries: results from a randomized multisite study.

OBJECTIVE: To examine whether supported employment (SE) is more effective than treatment as usual (TAU) in returning veterans to competitive employment after spinal cord injury (SCI). DESIGN: Prospective, randomized, controlled, multisite trial of SE versus TAU for vocational issues with 12 months of follow-up data. SETTING: SCI centers in the Veterans Health Administration. PARTICIPANTS: Subjects (N=201) were enrolled and completed baseline interviews. In interventional sites, subjects were randomly assigned to the SE condition (n=81) or the TAU condition (treatment as usual-interventional site [TAU-IS], n=76). In observational sites where the SE program was not available, 44 subjects were enrolled in a nonrandomized TAU condition (treatment as usual-observational site [TAU-OS]). INTERVENTIONS: The intervention consisted of an SE vocational rehabilitation program called the Spinal Cord Injury Vocational Integration Program, which adhered as closely as possible to principles of SE as developed and described in the individual placement and support model of SE for persons with mental illness. MAIN OUTCOME MEASURES: The primary study outcome measurement was competitive employment in the community. RESULTS: Subjects in the SE group were 2.5 times more likely than the TAU-IS group and 11.4 times more likely than the TAU-OS group to obtain competitive employment. CONCLUSIONS: To the best of our knowledge, this is the first and only controlled study of a specific vocational rehabilitation program to report improved employment outcomes for persons with SCI. SE, a well-prescribed method of integrated vocational care, was superior to usual practices in improving employment outcomes for veterans with SCI.

Identifying neck and back pain in administrative data: defining the right cohort.

STUDY DESIGN: We reviewed existing methods for identifying patients with neck and back pain in administrative data. We compared these methods using data from the Department of Veterans Affairs. OBJECTIVE: To answer the following questions: (1) what diagnosis codes should be used to identify patients with neck pain and back pain in administrative data; (2) because the majority of complaints are characterized as nonspecific or mechanical, what diagnosis codes should be used to identify patients with nonspecific or mechanical problems in administrative data; and (3) what procedure and surgical codes should be used to identify patients who have undergone a surgical procedure on the neck or back. SUMMARY OF BACKGROUND DATA: Musculoskeletal neck and back pain are pervasive problems, associated with chronic pain, disability, and high rates of health care utilization. Administrative data have been widely used in formative research, which has largely relied on the original work of Volinn, Cherkin, Deyo, and Einstadter and the Back Pain Patient Outcomes Assessment Team first published in 1992. Significant variation in reports of incidence, prevalence, and morbidity associated with these problems may be due to nonstandard or conflicting methods to define study cohorts. METHODS: A literature review produced 7 methods for identifying neck and back pain in administrative data. These code lists were used to search Veterans Health Administration data for patients with back and neck problems, and to further categorize each case by spinal segment involved, as nonspecific/mechanical and as surgical or not. RESULTS: There is considerable overlap in most algorithms. However, gaps persist. CONCLUSION: Gaps are evident in existing methods and a new framework to identify patients with neck pain and back pain in administrative data is proposed.

Variation in practices and attitudes of clinicians assessing PTSD-related disability among veterans.

One hundred thirty-eight Veterans Affairs mental health professionals completed a 128-item Posttraumatic Stress Disorder (PTSD) Practice Inventory that asked about their practices and attitudes related to disability assessment of PTSD. Results indicate strikingly wide variation in the attitudes and practices of clinicians conducting disability assessments for PTSD. In a high percentage of cases, these attitudes and practices conflict with best-practice guidelines. Specifically, 59% of clinicians reported rarely or never using testing, and only 17% indicated routinely using standardized clinical interviews. Less than 1% of respondents reported using functional assessment scales.

Outcomes of hospitalized patients with non-acute coronary syndrome and elevated cardiac troponin level.

OBJECTIVE: Cardiac troponin levels help risk-stratify patients presenting with an acute coronary syndrome. Although cardiac troponin levels may be elevated in patients presenting with non-acute coronary syndrome conditions, specific diagnoses and long-term outcomes within that cohort are unclear. METHODS: By using the Veterans Affairs centralized databases, we identified all hospitalized patients in 2006 who had a troponin assay obtained during their initial reference hospitalization. On the basis of the diagnostic codes of the International Classification of Diseases, 9th Revision, primary diagnoses were categorized as acute coronary syndrome or non-acute coronary syndrome conditions. RESULTS: Of a total of 21,668 patients with an elevated troponin level who were discharged from the hospital, 12,400 (57.2%) had a non-acute coronary syndrome condition. Among that cohort, the most common diagnostic category involved the cardiovascular system, and congestive heart failure (N=1661) and chronic coronary artery disease (N=1648) accounted for the major classifications. At 1 year after hospital discharge, mortality in patients with a non-acute coronary syndrome condition was 22.8% and was higher than in the acute coronary syndrome cohort (odds ratio 1.39; 95% confidence interval, 1.30-1.49). Despite the high prevalence of cardiovascular diseases in patients with a non-acute coronary syndrome diagnosis, use of cardiac imaging within 90 days of hospitalization was low compared with that in patients with acute coronary syndrome (odds ratio 0.25; 95% confidence interval, 0.23-0.27). CONCLUSIONS: Hospitalized patients with an elevated troponin level more often have a primary diagnosis that is not an acute coronary syndrome. Their long-term survival is poor and justifies novel diagnostic or therapeutic strategy-based studies to target the highest risk subsets before hospital discharge.

Mental health and substance use disorder spending in the Department of Veterans Affairs, fiscal years 2000-2007.

OBJECTIVE: This study analyzed spending for treatment of mental health and substance use disorders in the Department of Veterans Affairs (VA) in fiscal years (FYs) 2000 through 2007. METHODS: VA spending as reported in the VA Decision Support System was linked to patient utilization data as reported in the Patient Treatment Files, the National Patient Care Database, and the VA Fee Basis files. All care and costs from FY 2000 to FY 2007 were analyzed. RESULTS: Over the study period the number of veterans treated at the VA increased from 3.7 million to over 5.1 million (an average increase of 4.9% per year), and costs increased .7% per person per year. For mental health and substance use disorder treatment, the volume of inpatient care decreased markedly, residential care increased, and spending decreased on average 2% per year (from $668 in FY 2000 to $578 per person in FY 2007). FY 2007 saw large increases in mental health spending, bucking the trend from FY 2000 through FY 2006. CONCLUSIONS: VA's continued emphasis on outpatient and residential care was evident through 2007. This trend in spending might be unimpressive if VA were enrolling healthier Veterans, but the opposite seems to be true: over this time period the prevalence of most chronic conditions, including depression and posttraumatic stress disorder, increased. VA spending on mental health care grew rapidly in 2007, and given current military activities, this trend is likely to increase.

Administrative delays and chronic disability in patients with acute occupational low back injury.

OBJECTIVES: This study assessed whether an organizational factor, delays to claim acceptance or administrative delays, had an influence on outcomes for individuals with acute back injuries in the workers' compensation system. METHODS: Multivariate logistic regression was used to test whether individuals who experienced administrative delays were more likely to develop chronic disability than those who did not experience delays. RESULTS: Beyond the first 2 weeks, each interval of administrative delay was associated with increased odds of developing chronic disability. Injury severity, physician experience and weeks to medical treatment were additionally very strong predictors for the development of chronic disability. CONCLUSIONS: Insurers, employers, and policy makers can significantly reduce chronic disability if controls are adopted to reduce administrative and treatment delays and to direct workers to experienced clinicians.

Methods of a multisite randomized clinical trial of supported employment among veterans with spinal cord injury.

This article compares the methods of a randomized multisite clinical trial of evidence-based supported employment with conventional vocational rehabilitation among veterans with spinal cord injury (SCI). The primary hypothesis is that, compared with conventional vocational rehabilitation (i.e., standard care), evidence-based supported employment will significantly improve competitive employment outcomes and general rehabilitation outcomes. The secondary hypothesis is that evidence-based supported employment in SCI will be more cost-effective than standard care. The current article describes the clinical trial and presents baseline data. The present sample includes 301 veterans with SCI, which includes paraplegia (50%), high tetraplegia (32%), and low tetraplegia (18%). Baseline data indicate that 65% of this sample of employment-seeking veterans with SCI had never been employed postinjury, despite the fact that nearly half (41%) had received some type of prior vocational rehabilitation. These rates of unemployment for veterans with SCI are consistent with the rates reported for community samples of persons with SCI. Forthcoming outcome data will provide much needed insights into the best practices for helping these veterans restore vocational goals and improve overall quality of life.

Methodology to update the practice recommendations in the American College of Occupational and Environmental Medicine's Occupational Medicine Practice Guidelines, second edition.

OBJECTIVE: To ensure that revisions to the second edition of the American College of Occupational and Environmental Medicine (ACOEM) guidelines are as valid and useful as possible. METHODS: The ACOEM Guideline Methodology Committee searched and synthesized the evidence-based medicine literature on systematic review and guideline development. The resulting process and tools were tested during guideline revision, and changes were made to the tools and process. RESULTS: The methodology specifies problem formulation, literature search methods, screening of studies, quality rating, summarization of the body of literature, recommendation drafting and rating, "first principles" of medical logic and ethics, training, expert panel review, stakeholder input, external review, pilot testing and Board of Directors approval. CONCLUSIONS: The process and tools developed are consistent with international guideline assessment criteria, robust, and internally and externally valid.