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Background The items of the Patient Health Questionnaire-9 (PHQ-9) represent the criterion symptoms for DSM-IV major depression. This study evaluated the extent to which the PHQ-9 functions as a patient-reported outcome measure (PROM) specific to patients with major depressive disorder. Method Data were from the Veterans Outcome Assessment survey for 8848 patients beginning treatment in VA general mental health clinics, including 5754, re-surveyed after 3 months. The PHQ-9’s performance as a PROM was evaluated by comparing rank order correlations between both initial scores and improvements over 3 months between the PHQ-9 and several transdiagnostic PROMs across a range of diagnoses and comorbidities. Performance of PHQ-9-related patient-reported outcome-based performance measures (PROM-PM) were evaluated by comparing rates of response and remission across patient groups. Results Correlations between the PHQ-9 and transdiagnostic measures were significant and comparable in magnitude across a range of diagnoses and for cases with depression with or without comorbidities. Rates of response and remission were comparable across most patient groups. Limitations Limitations include use of clinical diagnoses as recorded in health records, and the relatively short time between assessments. Conclusions In these settings, the PHQ-9 functions more as a general measure of symptoms or distress than as a disease-specific scale. This supports its use as a PROM for patients beyond those with major depression, including those with related diagnoses and those with comorbidities, and use of related PROM-PMs in clinical settings where diagnoses may not be precise and comorbidities may be common.

Individuals with mental or substance use disorders have higher mortality rates than people in the general population. How excess mortality varies across health care facilities is unknown. The authors sought to investigate facility-level mortality rates among Veterans Health Administration (VHA) patients who had received diagnoses of mental or substance use disorders.An electronic medical records-based retrospective cohort study was conducted, encompassing 8,812,373 unique users of 139 VHA facilities from 2011 to 2016. Covariates included age, sex, and past-year diagnoses of serious mental illness, posttraumatic stress disorder, major depressive disorder, other mental health conditions, or substance use disorders. The outcome was all-cause mortality per comprehensive Veterans Affairs/Department of Defense searches of the National Death Index. Proportional hazards regression was used to calculate overall and facility-specific hazard ratios (HRs) for each diagnosis group, adjusted for age, sex, and comorbid medical conditions.Overall, all-cause mortality was statistically significantly elevated among VHA users with mental health diagnoses (HR=1.21, 95% confidence interval=1.20-1.22). HRs varied across facilities consistently over time. At the VHA facility level, diagnostic groups were significantly correlated with the degree of excess mortality. Results were similar in sensitivity analyses that excluded deaths from suicide or drug or alcohol overdose.VHA users with mental or substance use disorder diagnoses had elevated mortality rates. Correlation in excess mortality across two periods indicated that facility differences in excess mortality were persistent and therefore potentially associated with facility- and community-level factors, which may help inform quality improvement efforts to reduce mortality rates.

Objectives To assess outcomes for Veterans Health Administration (VHA) patients following calls to the Veterans Crisis Line (VCL). Methods 158,927 VHA patients had an initial VCL call in 2010-2015 with documented identifiers. Multivariable proportional hazards regressions assessed risks of suicide and suicide-related behavior through 12 months. Covariates included age, sex, region, mental health encounters in the prior year, time of day, weekday/weekend status, call outcome, and responder determination of caller risk. Results Annualized suicide rates per 100,000 within 1, 3, 6, and 12 months were 797, 520, 387, and 298, respectively. Average age was 49.9 (SD = 15.2), 86.5% were male, 68.6% received mental health encounters in the prior year, and 5.9% had calls categorized as at high risk. Adjusting for covariates, suicide risk was greater among male callers and those with calls categorized as at high or moderate risk. Conclusions Veterans Crisis Line serves a high-risk population at a critical time. Rates were particularly high within one month and remained substantially elevated through 12 months. Findings have directly informed ongoing efforts to enhance coordination between VCL and VHA to support suicide prevention.

The Veterans Health Administration (VHA) provides a continuum of care over the life course. Among U.S. adults, bipolar disorder and schizophrenia are associated with increased risk of dementia. To inform service planning, this study assessed the incidence of dementia among veteran VHA patients with bipolar disorder or schizophrenia, with adjustment for comorbid medical conditions.Using data from the VHA Corporate Data Warehouse, the authors identified all veterans who received VHA care in 2004 and 2005 without a dementia diagnosis and who were alive and between ages 18 and 100 as of January 1, 2006. Individuals were categorized as having bipolar disorder, schizophrenia, or neither condition on the basis of diagnoses in 2004-2005. Among ongoing VHA users, incidence of dementia was assessed for up to 10 years (2006-2015).The cohort included 3,648,852 individuals. After analyses controlled for baseline comorbid general medical conditions and substance use disorders, the incidence rate ratios (IRRs) for dementia were 2.92 for those with schizophrenia and 2.26 for those with bipolar disorder, compared with VHA patients with neither condition.Among veterans receiving VHA care, diagnoses of bipolar disorder and schizophrenia were each associated with increased risk of receiving a new diagnosis of dementia, even when analyses controlled for baseline medical comorbidities. IRRs were elevated for patients with either condition, compared with those with neither condition, and highest for those with schizophrenia. VHA clinicians should evaluate patients for dementia when signs or symptoms of cognitive impairment are present.

Key Points Question Is the Veterans Health Administration Recovery Engagement and Coordination for Health–Veterans Enhanced Treatment (REACH VET) program, which facilitates care enhancements for individuals in the top 0.1% suicide risk tier using a validated algorithm, associated with health care utilization, treatment engagement, suicide attempts, suicide safety plan documentation, and suicide mortality? Findings In this cohort study including 173 313 individuals before and after implementation of the REACH VET program using triple differences, inclusion in the REACH VET program was associated with having more outpatient encounters, increased documentation of new suicide prevention safety plans, and fewer inpatient mental health admissions, emergency department visits, and documented suicide attempts. Meaning These findings suggest that clinical programs using predictive modeling can support care enhancements and risk reduction., This cohort study examines treatment engagement, health care utilization, and suicide-related outcomes associated with the Veterans Health Administration's Recovery Engagement and Coordination for Health–Veterans Enhanced Treatment (REACH VET) suicide risk modeling clinical program., Importance The Veterans Health Administration (VHA) implemented a national clinical program using a suicide risk prediction algorithm, Recovery Engagement and Coordination for Health–Veterans Enhanced Treatment (REACH VET), in which clinicians facilitate care enhancements for individuals identified in local top 0.1% suicide risk tiers. Evaluation studies are needed. Objective To determine associations with treatment engagement, health care utilization, suicide attempts, safety plan documentation, and 6-month mortality. Design, Setting, and Participants This cohort study used triple differences analyses comparing 6-month changes in outcomes after vs before program entry for individuals entering the REACH VET program (March 2017-December 2018) vs a similarly identified top 0.1% suicide risk tier cohort from prior to program initiation (March 2014-December 2015), adjusting for trends across subthreshold cohorts. Subcohort analyses (including individuals from March 2017-June 2018) evaluated difference-in-differences for cause-specific mortality using death certificate data. The subthreshold cohorts included individuals in the top 0.3% to 0.1% suicide risk tier, below the threshold for REACH VET eligibility, from the concurrent REACH VET period and from the pre–REACH VET period. Data were analyzed from December 2019 through September 2021. Exposures REACH VET–designated clinicians treatment reevaluation and outreach for care enhancements, including safety planning, increased monitoring, and interventions to enhance coping. Main Outcomes and Measures Process outcomes included VHA scheduled, completed, and missed appointments; mental health visits; and safety plan documentation and documentation within 6 months for individuals without plans within the prior 2 years. Clinical outcomes included mental health admissions, emergency department visits, nonfatal suicide attempts, and all-cause, suicide, and nonsuicide external-cause mortality. Results A total of 173 313 individuals (mean [SD] age, 51.0 [14.7] years; 161 264 [93.1%] men and 12 049 [7.0%] women) were included in analyses, including 40 816 individuals eligible for REACH VET care and 36 604 individuals from the pre–REACH VET period in the top 0.1% of suicide risk. The REACH VET intervention was associated with significant increases in completed outpatient appointments (adjusted triple difference [ATD], 0.31; 95% CI, 0.06 to 0.55) and proportion of individuals with new safety plans (ATD, 0.08; 95% CI, 0.06 to 0.10) and reductions in mental health admissions (ATD, −0.08; 95% CI, −0.10 to −0.05), emergency department visits (ADT, −0.03; 95% CI, −0.06 to −0.01), and suicide attempts (ADT, −0.05; 95% CI, −0.06 to −0.03). Subcohort analyses did not identify differences in suicide or all-cause mortality (eg, age-and-sex-adjusted difference-in-difference for suicide mortality, 0.0007; 95% CI, −0.0006 to 0.0019). Conclusions and Relevance These findings suggest that REACH VET implementation was associated with greater treatment engagement and new safety plan documentation and fewer mental health admissions, emergency department visits, and suicide attempts. Clinical programs using risk modeling may be effective tools to support care enhancements and risk reduction.

Objective To evaluate the associations of self-reports of suicidal ideation and behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) in a survey of patients receiving mental health services in the Veterans Health Administration (VHA) with reports of attempts documented in medical records and administrative data. Method The C-SSRS was administered to 15,373 Veterans in the Veterans Outcome Assessment (VOA) survey. Concurrent validity was evaluated by comparing self-reports from the past 3 months with VHA records. Predictive validity was evaluated by logistic regression models using attempts over the subsequent 3 months as the outcome. Results Tests of concurrent validity found strong associations between self-reports and attempts documented in VHA records, but there were substantial numbers of discordant responses. In tests of predictive validity, area under the ROC curve for predicting future attempts was >0.8. There were differences in the distribution of responses and of psychometric properties across VHA mental health programs. Conclusions Findings support the value of screening and the validity of the self-reports based on the C-SSRS, but limitations in concordance with medical records and variability across programs suggest the need for clinical judgment in interpreting responses.

Objective:Studies of patients in the U.S. Department of Veterans Affairs (VA) health system and elsewhere have documented elevated mortality from suicide during a critical period within 30 to 90 da...

INTRODUCTION Veterans who receive Veterans Health Administration (VHA) Home Based Primary Care (HBPC) services and those discharged from VHA Community Living Centers (CLC) may be at increased risk of suicide. No studies to date have assessed suicide risks among HBPC patients. This study examined suicide risks among recipients of VHA HBPC services and following discharge from VHA CLCs, as compared to other Veteran VHA users. METHODS We identified three cohorts of 2013 Veteran VHA patients: 47,842 HBPC users, 17,725 with live discharges from CLCs, and 5,554,635 other VHA users. Using proportional hazards regression, we assessed risk of suicide through 2016. RESULTS Overall, HBPC recipients did not differ from the other cohorts in suicide risk. Although in unadjusted analyses CLC discharged patients had greater suicide risk than the general VHA patient cohort (hazard ratio (HR) = 1.73, 95% confidence interval = 1.25-2.41), this became nonsignificant when controlling for diagnoses. CONCLUSIONS Overall findings did not identify differential suicide risk among VHA HBPC recipients in 2013, when compared to other Veteran VHA patient cohorts. Veterans discharged from VHA CLCs have increased mental health morbidity, which was associated with increased suicide risk.

For mental health, evidence linking the patients' experiences of care with treatment outcomes is limited. We report findings from the Veterans Outcome Assessment (VOA) survey of Veterans beginning treatment in Veterans Health Administration (VHA) mental health programs with follow-up after approximately 3 months. In addition to assessments of symptoms and functioning, it includes key components of the Experience of Care and Health Outcomes (ECHO) survey including patient reports of communication with clinicians and of the overall quality of mental health care. For Veterans treated in VHA general mental health clinics, significant associations between ratings of communication and quality at baseline, and both retention in treatment and patient-reported outcomes assessed at follow-up demonstrate that better patient experience predicts more favorable outcomes. Further research is necessary to determine whether including them in measurement-based care could improve outcomes by facilitating the early identification of problems in providing care.

The Veterans Outcomes Assessment (VOA) program surveys Veteran Health Administration (VHA) patients when they begin mental health treatment and at follow-up at three months to obtain patient-reported outcomes measures (PROM). It complements VA's evolving program in measurement-based care by providing additional data that can be useful for program evaluation including assessments of patients who have not been seen for ongoing mental health care. In principle, it provides data on intention-to-treat outcomes for program evaluation to complement the outcomes for patients who are receiving ongoing treatment that can be derived from measurement-based care. VOA findings confirm differences in outcomes between patients who have continued to be seen for treatment and those who have not. Patients in general mental health clinics with no encounters between the baseline and follow-up assessments who reported discontinuing care because they did not want or need treatment improved more, and those who discontinued due to problems improved less than those who remained in treatment. Experience with VOA has identified a number of issues that must be addressed before it is possible to use intention-to-treat outcomes for program evaluation.

Background Patient-centeredness is a cornerstone of substance use disorder (SUD) treatment. Patient-experience measures are potential tools for the routine assessment of patient-centered SUD care and may be valuable measures to inform quality monitoring improvement efforts. Little research exists on the predictive validity of patient-experience measures in SUD care. Purpose We report on findings from the Veterans Outcome Assessment (VOA) survey that provides information on Veterans Health Administration SUD specialty care at treatment initiation and approximately 3-months post-initiation. Methods The VOA includes patient-reported outcomes across multiple domains, including the Brief Addiction Monitor (BAM-R), the Short-Form-12 (SF-12) and the Experience of Care and Health Outcome Survey (ECHO), and provides patient reports of the quality of provider communication and overall quality of SUD care. Results Nearly 40% of veterans in SUD care gave the highest possible ratings for communication and quality at both baseline and follow-up. Ratings of communication at 3-months were associated with treatment discontinuation and both ratings of communication and quality at 3-months and were independently associated with SUD symptoms and with mental well-being at 3-months. Conclusions This study provides preliminary support for the inclusion of patient experience measures, particularly ratings of provider communication, as part of routine assessment in SUD care. However, further work on the validity of ratings of provider communication using additional methodologies is likely important before piloting the inclusion of such measures in routine assessment, such as in measurement base care.

Importance Suicide and suicide attempts are persistent and increasing public health problems. Observational studies and meta-analyses of randomized clinical trials have suggested that lithium may prevent suicide in patients with bipolar disorder or depression. Objective To assess whether lithium augmentation of usual care reduces the rate of repeated episodes of suicide-related events (repeated suicide attempts, interrupted attempts, hospitalizations to prevent suicide, and deaths from suicide) in participants with bipolar disorder or depression who have survived a recent event. Design, Setting, and Participants This double-blind, placebo-controlled randomized clinical trial assessed lithium vs placebo augmentation of usual care in veterans with bipolar disorder or depression who had survived a recent suicide-related event. Veterans at 29 VA medical centers who had an episode of suicidal behavior or an inpatient admission to prevent suicide within 6 months were screened between July 1, 2015, and March 31, 2019. Interventions Participants were randomized to receive extended-release lithium carbonate beginning at 600 mg/d or placebo. Main Outcomes and Measures Time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. Results The trial was stopped for futility after 519 veterans (mean [SD] age, 42.8 [12.4] years; 437 [84.2%] male) were randomized: 255 to lithium and 264 to placebo. Mean lithium concentrations at 3 months were 0.54 mEq/L for patients with bipolar disorder and 0.46 mEq/L for patients with major depressive disorder. No overall difference in repeated suicide-related events between treatments was found (hazard ratio, 1.10; 95% CI, 0.77-1.55). No unanticipated safety concerns were observed. A total of 127 participants (24.5%) had suicide-related outcomes: 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and 3 in the placebo group. Conclusions and Relevance In this randomized clinical trial, the addition of lithium to usual Veterans Affairs mental health care did not reduce the incidence of suicide-related events in veterans with major depression or bipolar disorders who experienced a recent suicide event. Therefore, simply adding lithium to existing medication regimens is unlikely to be effective for preventing a broad range of suicide-related events in patients who are actively being treated for mood disorders and substantial comorbidities. Trial Registration ClinicalTrials.gov Identifier:NCT01928446

Background and Aims Limited information is available regarding links between specific substance use disorders (SUDs) and suicide mortality; however, the preliminary evidence that is available suggests that suicide risk associated with SUDs may differ for men and women. This study aimed to estimate associations between SUDs and suicide for men and women receiving Veterans Health Administration (VHA) care. Design A cohort study using national administrative health records. Setting National VHA system, USA. Participants All VHA users in fiscal year (FY) 2005 who were alive at the beginning of FY 2006 (n = 4 863 086). Measurements The primary outcome of suicide mortality was assessed via FY 2006–2011 National Death Index (NDI) records. Current SUD diagnoses were the primary predictors of interest, and were assessed via FY 2004–2005 VHA National Patient Care Database (NPCD) records. Findings In unadjusted analyses, a diagnosis of any current SUD and the specific current diagnoses of alcohol, cocaine, cannabis, opioid, amphetamine and sedative use disorders were all associated significantly with increased risk of suicide for both males and females [hazard ratios (HRs)] ranging from 1.35 for cocaine use disorder to 4.74 for sedative use disorder for men, and 3.89 for cannabis use disorder to 11.36 for sedative use disorder for women]. Further, the HR estimates for the relations between any SUD, alcohol, cocaine and opioid use disorders and suicide were significantly stronger for women than men (P

Deaths of despair, a composite outcome including suicide and drug- and alcohol-related deaths, have been increasing, especially in subpopulations and geographic areas sensitive to economic and social hardships. The Veterans Health Administration (VHA) has begun evaluating the utility of this concept to guide planning and evaluations of clinical and preventive services for Veterans. In this study, mortality rates for middle-aged American men for 2013 to 2017 were from CDC WONDER, and rates for all Veterans, those using VHA healthcare services (VHA-utilizers), and other (non-VHA) Veterans were derived from National Death Index data. Findings demonstrated that rates for the composite were higher in VHA-utilizers and lower in non-VHA Veterans than middle-aged American men, consistent with use of VHA services by Veterans with the greatest needs. State rates in Veteran men were significantly and positively correlated with state rates for American men, and both were correlated with other characteristics of the social environment. The lack of correlation between rates for suicide and drug-related deaths indicates that deaths of despair cannot be modeled by assuming parallel paths from reactions to community-based stressors to the component outcomes; models should allow for an impact of community characteristics on partitioning between outcomes.

Background and objectives The purpose of this study is to assess trends in opioid-involved overdose mortality among US Veterans. Methods Age-adjusted drug overdose mortality rates, overall and by opioid subtype, were assessed from National Death Index data for US Veterans; statistical significance of trends was assessed for 2010 to 2015 and 2015 to 2016. Results Veteran age-adjusted overdose mortality rates increased 23.7% from 2010 to 2015 (19.7-24.4 of 100 000) and a further 20.4% through 2016 (29.3 of 100 000). Opioid involvement increased from 51.3% in 2010 to 62.1% in 2016, as opioid overdose rates increased from 10.9 to 19.5 of 100 000. Overdose mortality varied substantially by opioid subtype and demographics. Conclusions and scientific significance This report provides the first-ever description of trends and characteristics of overdose mortality and opioid-involved deaths among US Veterans of military service for the period 2010 to 2016. With the exception of female Veterans and Veterans in Western States, it has been found that trends in Veteran overdose mortality paralleled rising rates of drug overdose observed in the United States more broadly. Published 2020. This article is a U.S. Government work and is in the public domain in the USA. (Am J Addict 2020;00:00-00).

12130 Background: Patients diagnosed with cancer are at an increased risk of adverse mental health outcomes including suicidal behavior. Suicide rates among Veterans are 50 percent greater than for non-Veteran US adults. To inform Veterans Affairs (VA) suicide prevention initiatives, it is important to understand associations between cancer and suicide risk among Veterans receiving VA healthcare from the Veterans Health Administration (VHA). Study aims were to assess associations between new cancer diagnoses and suicide among Veterans in VHA care to identify high risk diagnostic subgroups and risk-periods. Methods: We used a cohort study design, identifying 4,926,373 Veterans with VHA use in 2011 and either 2012 or 2013 and without a VHA cancer diagnosis in 2011. Incident cancer diagnoses, assessed between first VHA use in 2012-2013 and 12/31/2018, were characterized by subtype and stage using the VHA Oncology Raw Data. Data from the VA/Department of Defense Mortality Data Repository identified date and cause of death. Cox proportional hazards regression, accounting for time-varying cancer diagnosis, was used to evaluate associations between a new cancer diagnosis and suicide risk. An initial model adjusted for VHA regional network and patient age and sex. Cancer subtypes with significant associations with suicide were further assessed using a model that also adjusted for suicide attempts and mental health, tobacco use disorder, and other substance use disorder diagnoses in the prior year. Crude suicide rates following a new cancer diagnoses were calculated among Veterans with new diagnoses, 2012-2018 (N = 240,410). Rates were assessed up to 84 months following diagnosis. Results: On average, Veteran VHA users were followed for 6.0 years after their first VHA use in 2012-2013 and for 2.7 years following a new cancer diagnosis. Receipt of a new cancer diagnosis corresponded to a 43% (Adjusted Hazard Ratio [AHR] = 1.43, 95% CI: 1.29, 1.58) higher suicide risk, adjusting for covariates. The cancer subtype associated with the highest suicide risk was esophageal cancer (AHR = 5.93, 95% CI: 4.05, 10.51) and other significant subtypes included head and neck (AHR = 3.44, 95% CI: 2.65, 4.46) and lung cancer (AHR = 2.28, 95% CI: 1.79, 2.90). Cancer stages 3 (AHR = 2.29, 95% CI: 1.75, 3.01) and 4 (AHR = 3.45, 95% CI: 2.75, 4.34) at diagnosis were also positively associated with suicide risk. Suicide rates were highest in the first three months following a diagnosis (Rate = 128.3 per 100,000 person-years, 95% CI: 100.4, 161.6) and remained elevated through the first 12 months. Conclusions: Among Veteran VHA users, suicide risk was elevated following a new cancer diagnosis and was especially high in the initial 3 months. Additional screening and suicide prevention efforts may be warranted for VHA Veterans newly diagnosed with cancer, particularly among those diagnosed with esophageal, head and neck, or lung cancer or at stages 3 or 4.

Background The estimation of an effect size is an important step in designing an adequately powered, feasible clinical trial intended to change clinical practice. During the planning phase of VA Cooperative Study #590, “Double-Blind Placebo-Controlled Study of Lithium for Preventing Repeated Suicidal Self-Directed Violence in Patients with Depression or Bipolar Disorder (Li+),” it was not clear what effect size would be considered large enough to influence prescribing behavior among practicing clinicians. Methods We conducted an online survey of VA psychiatrists to assess their interest in the study question, their clinical experience with lithium, and their opinion about what suicide reduction rate would change their prescribing habits. The 9-item survey was hosted on SurveyMonkey© and VA psychiatrists were individually emailed an invitation to complete an anonymous online survey. Three email waves were sent over three weeks. Results Overall, 862 of 2713 VA psychiatrists (response rate = 31.8%) responded to the anonymous survey. 74% of the respondents would refer a patient to the proposed trial, 9% would not, and 17% were unsure. Presented with suicide reduction rates in 10% increments ranging from 10 to 100%, 61% of respondents indicated that they would use lithium if suicide attempts were reduced by at least 40%; 83% would use lithium if it reduced attempts by at least 50%. Conclusions Even with the limitations of response bias and the reliability of responses on future prescribing behavior, a survey of potential users of a clinical trial's results offers a convenient, empirical method for determining and justifying clinically relevant effect sizes.

Objectives The US Veterans Health Administration (VHA) has begun using predictive modeling to identify Veterans at high suicide risk to target care. Initial analyses are reported here. Methods A penalized logistic regression model was compared with an earlier proof-of-concept logistic model. Exploratory analyses then considered commonly-used machine learning algorithms. Analyses were based on electronic medical records for all 6,360 individuals classified in the National Death Index as having died by suicide in fiscal years 2009–2011 who used VHA services the year of their death or prior year and a 1% probability sample of time-matched VHA service users alive at the index date (n = 2,112,008). Results A penalized logistic model with 61 predictors had sensitivity comparable to the proof-of-concept model (which had 381 predictors) at target thresholds. The machine learning algorithms had relatively similar sensitivities, the highest being for Bayesian additive regression trees, with 10.7% of suicides occurred among the 1.0% of Veterans with highest predicted risk and 28.1% among the 5.0% of with highest predicted risk. Conclusions Based on these results, VHA is using penalized logistic regression in initial intervention implementation. The paper concludes with a discussion of other practical issues that might be explored to increase model performance.

Background Post-traumatic stress disorder (PTSD) confers risk for suicidal ideation and suicide attempts but a link with suicide is not yet established. Prior analyses of users of the Veterans health administration (VHA) Health System suggest that other mental disorders strongly influence the association between PTSD and suicide in this population. We examined the association between PTSD and suicide in VHA users, with a focus on the influence of other mental disorders. Methods Data were based on linkage of VA National Patient Care Database records and the Centers for Disease Control and Prevention׳s National Death Index, with data from fiscal year 2007–2008. Analyses were based on multivariate logistic regression and structural equation models. Results Among users of VHA services studied ( N =5,913,648), 0.6% ( N =3620) died by suicide, including 423 who had had been diagnosed with PTSD. In unadjusted analysis, PTSD was associated with increased risk for suicide, with odds ratio, OR (95% confidence interval, 95% CI)=1.34 (1.21, 1.48). Similar results were obtained after adjustment for demographic variables and veteran characteristics. After adjustment for multiple other mental disorder diagnoses, PTSD was associated with decreased risk for suicide, OR (95% CI)=0.77 (0.69, 0.86). Major depressive disorder (MDD) had the largest influence on the association between PTSD and suicide. Limitations The analyses were cross-sectional. VHA users were studied, with unclear relevance to other populations. Conclusion The findings suggest the importance of identifying and treating comorbid MDD and other mental disorders in VHA users diagnosed with PTSD in suicide prevention efforts.

BACKGROUND AND AIMS: Tobacco use may be a risk factor for suicide mortality; however, prior research has produced equivocal findings, and has been limited by relatively small sample sizes to study the rare event of suicide, as well as a lack of adjustment for other important factors, including psychiatric illness. We estimate the predictive association between tobacco use disorder and the risk of suicide mortality, adjusting for other important variables. DESIGN: A prospective cohort study. SETTING: The United States Veterans Health Administration (VHA). PARTICIPANTS: All individuals who received VHA services in Fiscal Year 2005 and were alive at the start of Fiscal Year 2006 (n= 4,863,086). MEASUREMENTS: Tobacco use disorder was assessed via Fiscal Year 2004-2005 VHA National Patient Care Database records. The outcome of suicide mortality was assessed during the follow-up interval from Fiscal Year 2006 through Fiscal Year 2008 using National Death Index records. FINDINGS: Of the 4,863,086 individuals in the study, 4823 died by suicide during the follow-up interval. In the unadjusted model, tobacco use disorder was associated with an increased risk of suicide (Hazard Ratio=1.88; 95% Confidence Interval=1.76, 2.02). After adjustment for model covariates, the association remained statistically significant, although attenuated (Hazard Ratio =1.36, 95% Confidence Interval =1.27, 1.46). CONCLUSIONS: Tobacco use disorder may confer a modest excess risk of death by suicide. Psychiatric disorders may partially explain the relationship between tobacco use disorder and suicide. Language: en

T issue of the American Journal of Geriatric Psychiatry includes seven articles from investigators in the Veterans Health Administration, the health system of the U.S. Department of Veterans Affairs (VA). Thearticles speak to thebreadthof expertise andexperience in geriatric psychiatry within the VA, in areas of special concern to Veterans as well as those that are of general importance to the entire population. Two of the articles deal with a specific focus for VA, posttraumatic stress disorder (PTSD) as it occurs in late life.1,2 This is a condition that is more common and more likely to be recognized in VA than in other settings, but it is, by no means, unique either to VA or to Veterans. Knowledge gained from the VA can be of value in guiding the diagnosis, evaluation, and treatment of the condition as it occurs, less frequently, in other settings. Four of the articles report on lessons learned from research on Veterans that are important across populations. Two articles report on issues related to the integration of mental health services with primary care,3,4 reflecting lessons learned during VA’s ongoing national implementation of integrated care programs. One article reports a systemwide look at the treatment of late-life depression,5 an investigation that was facilitated by the availability of VA’s electronic medical record system. One article reports on family caregiving for Veterans with dementia6; it is a product of collaborationbetweenVAandcommunitybased investigators and represents the types of partnerships that are needed to address the needs of Veterans with chronic disease and disability as they live within their families and communities. Finally, one of the articles askswhether the clinical features ofmental health conditions (late-life schizophrenia or schizoaffective disorder) differed between Veterans and other older men.7 The answer is that they do, and that, in important ways, older men with a history of military services may have a more benign course when they experience these conditions in late life. The question about whether Veterans are different from other Americans, even years after their military service, is an important one. Veterans are distinguished by their history of service to their country, their training, and their membership in the unique culture shared by military service members and Veterans, all of which are important strengths. However, they may also experience service-connected and combat-relatedmental health andmedical conditions. In many cases, Veterans view these as challenges to be overcome. However, all too often these conditions lead to suffering and disability. Moreover, they interact with the aging process, affecting Veterans in different ways at different periods in their lives. It is useful to extend the question about differences to askwhether healthcare inVA is different fromother healthcare systems in America. VA has specialized services, and VA providers have extensive experience in addressing service-connected and combat-related conditions that may be uncommon in other settings. Moreover, it provides care for these and other conditions in a way that is sensitive and responsive to military and Veterans culture. Beyond the issues related

Suicide crisis lines have a respected history as a strategy for reducing deaths from suicide and suicidal behaviors. Until recently, however, evidence of the effectiveness of these crisis lines has been sparse. Studies published during the past decade suggest that crisis lines offer an alternative to populations who may not be willing to engage in treatment through traditional mental health settings. Given this promising evidence, in 2007, the Department of Veterans Affairs in collaboration with the Department of Health and Human Services’ Substance Abuse and Mental Health Administration implemented a National Suicide Hotline that is staffed 24 hours a day, 7 days a week, by Veterans Affairs clinical staff. We report here on the implementation of this suicide hotline and our early observations of its utilization in a largely male population.

Frequency of suicidal ideation in the past two weeks, assessed by item 9 of the nine-item Patient Health Questionnaire (PHQ-9), has been positively associated with suicide mortality among patients in a setting other than the Veterans Health Administration (VHA). To inform suicide prevention activities at the VHA, it is important to evaluate whether item 9 is associated with suicide risk among patients in the VHA system.PHQ-9 assessments (N=447,245) conducted by the VHA between October 1, 2009, and September 30, 2010, were collected. National Death Index data were used to ascertain suicide mortality from the date of PHQ-9 assessment through September 30, 2011. Multivariable proportional hazards regressions were used to evaluate associations between responses to item 9 and suicide mortality.After the analyses adjusted for covariates, a response of "several days" for item 9 was associated with a 75% increased risk of suicide (hazard ratio [HR]=1.75, 95% confidence interval [CI]=1.24-2.46), a response of "more than half the days" was associated with a 115% increased risk of suicide (HR=2.15, CI=1.32-3.51), and a response of "nearly every day" was associated with a 185% increased risk of suicide (HR=2.85, CI=1.81-4.47), compared with a response of "not at all." However, 71.6% of suicides during the study period occurred among patients who responded "not at all" to item 9 from their most recent PHQ-9.Higher levels of suicidal ideation, indicated by item 9 of the PHQ-9, were associated with increased risk of suicide among patients in the VHA system.

OBJECTIVES: To investigate whether pain severity and interference with normal work activities moderate the effects of depression treatment on changes in depressive symptoms over time in older adults in primary care. DESIGN: Patient-randomized, clinical trial. SETTING: Multisite: three clinics located in Veterans Affairs Medical Centers. PARTICIPANTS: Adults aged 60 and older (n=524) who screened positive for depression and participated in the Primary Care Research in Substance Abuse and Mental Health for the Elderly Study. INTERVENTION: Integrated care versus enhanced specialty referral care. MEASUREMENTS: Pain severity, the degree to which pain interferes with work inside and outside of the home, and depressive symptoms were examined at baseline and 3, 6, and 12 months. RESULTS: Intention-to-treat analyses revealed that both treatment groups showed reduced depressive symptoms over time, although self-reported pain moderated reductions in depressive symptoms. At higher levels of pain severity and interference with work activities, improvements in depressive symptoms were blunted. Furthermore, pain interference appeared to have a greater effect on depressive symptoms than did pain severity; in individuals with major depression, pain interference fully accounted for the moderating effects of pain severity on changes in depressive symptoms over time. CONCLUSION: Pain and its interference with functioning interfere with recovery from depression. Findings highlight the importance of addressing multiple domains of functioning (e.g., physical and social disability) and the degree to which pain and other forms of physical comorbidity may hinder or minimize treatment-related improvements in depressive symptoms.

Objectives. The Veterans Health Administration (VHA) evaluated the use of predictive modeling to identify patients at risk for suicide and to supplement ongoing care with risk-stratified interventions. Methods. Suicide data came from the National Death Index. Predictors were measures from VHA clinical records incorporating patient-months from October 1, 2008, to September 30, 2011, for all suicide decedents and 1% of living patients, divided randomly into development and validation samples. We used data on all patients alive on September 30, 2010, to evaluate predictions of suicide risk over 1 year. Results. Modeling demonstrated that suicide rates were 82 and 60 times greater than the rate in the overall sample in the highest 0.01% stratum for calculated risk for the development and validation samples, respectively; 39 and 30 times greater in the highest 0.10%; 14 and 12 times greater in the highest 1.00%; and 6.3 and 5.7 times greater in the highest 5.00%. Conclusions. Predictive modeling can identify high-risk patients who were not identified on clinical grounds. VHA is developing modeling to enhance clinical care and to guide the delivery of preventive interventions.

Objectives The objectives of this study were to evaluate the efficacy, safety, and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning. Method The authors conducted a multicenter, double-blind, placebo-controlled, randomized trial of flexibly dosed quetiapine and haloperidol. Primary outcomes were change in total Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impressions–Severity of Illness (CGI-S) scores at week 10. Secondary outcomes included BPRS factors, Neuropsychiatric Inventory (NPI), Multidimensional Observation Scale for Elderly Subjects (MOSES), and Physical Self-Maintenance Scale (PSMS). Results Two hundred eighty-four participants (mean age: 83.2 years) were randomized; 63.4% completed; and mean Mini-Mental State Examination score was 12.8. Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol. No differential benefit was seen on any psychosis measure. BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol. BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo. No NPI factors showed change, including the agitation factor. MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine. Somnolence occurred in 25.3%, 36.2%, and 4.1% of the quetiapine, haloperidol, and placebo groups, respectively; parkinsonism was most prevalent in the haloperidol group; other safety and tolerability measures differed little among groups. Conclusion All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed. Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation. Tolerability was better with quetiapine compared with haloperidol.

OBJECTIVES: To evaluate patient reports of changes in depressive symptoms as information that can be used in treatment decision-making. DESIGN: Longitudinal cohort study. SETTING: The Prevention of Suicide in Primary Care Elderly: Collaborative Trial and the Primary Care Research in Substance Abuse and Mental Health for the Elderly trial, multisite studies investigating the effect of depression interventions on outcomes in primary care. PARTICIPANTS: Fifty-six patients aged 60 and older. MEASUREMENTS: Patient demographics were collected from patient reports. Symptoms of depression were measured using the Centers for Epidemiologic Studies Depression Scale (CES-D) and Hamilton Depression Scale (HAM-D). Changes in depressive symptoms were also measured using the Clinical Global Impressions of Change (CGI-C) as rated by patients in ongoing treatment. RESULTS: Patient ratings of CGI-C were significantly correlated with percentage improvement on the HAM-D as rated by the depression care manager (correlation coefficient (r)=0.44, P

OBJECTIVES: To test for simvastatin-induced changes in affect and affective processes in elderly volunteers. DESIGN: Randomized, clinical trial. SETTING: The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania. PARTICIPANTS: Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol. INTERVENTION: Simvastatin up to 20 mg/d or placebo for 15 weeks. MEASUREMENTS: Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events. RESULTS: Thirty-one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication-by-time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication-by-event, and medication-by-event-by-time interactions, reflecting a time-limited increase in the apparent effect of negative events. CONCLUSION: Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.

The aim of this study was to develop the use of daily diaries of affects and events as measures of pharmacological effects on affective processes and to apply them to evaluate the possible affective toxicity of metoclopramide and naproxen, two medications commonly used in geriatric practice. In all, 105 adults aged 65 years or older were randomized to receive metoclopramide (up to 40 mg/day), naproxen (up to 1000 mg/day), or placebo under double-blind conditions for a period of 5 weeks. Patients were seen weekly for evaluations of affective and cognitive outcomes as well as safety. In addition, patients kept diaries with daily records of positive and negative affect and reports of significant daily events. Findings included mixed model analyses of drug assignment, time, events, and interactions for both positive affect and days with significant negative affect. Subjects exhibited high levels of adherence in completing daily diaries. Neither the pattern of dropouts nor the weekly assessments demonstrated significant drug effects on mood or affect. However, diary data demonstrated that metoclopramide increased the apparent impact of negative events on both positive and negative affect relative to placebo, and that naproxen increased the apparent impact of positive events on positive affect and, possibly, of negative events on negative affect relative to placebo. The findings confirm the utility of diary methods for studying drug effects on affective processes in normal elderly subjects. They suggest that both metoclopramide and naproxen can affect the associations between daily events and affects. If replicated, they would demonstrate that drug effects can extend beyond the intensity of affect and/or the emergence of full-fledged psychiatric disorders to include moderation of the interactions between daily events and affect.

This study compared time to first remission for elderly depressed patients in primary care for practices that implemented a care management model versus those providing usual care. In addition, it sought to identify risk factors for nonremission that could guide treatment planning and referral to care managers or specialists.Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) data were analyzed. Participants were older patients (or =60 years) selected following screening of 9,072 randomly identified primary care patients. The present analysis examined patients with major depression and a 24-item Hamilton Depression Rating Scale score of 18 or greater who were followed for at least 4 months (N=215). Primary care practices were randomly assigned to offer the PROSPECT intervention or usual care. The intervention consisted of services of trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 18 months.First remission occurred earlier and was more common among patients receiving the intervention than among those receiving usual care. For all patients, limitations in physical and emotional functions predicted poor remission rate. Patients experiencing hopelessness were more likely to achieve remission if treated in intervention practices. Similarly, the intervention was more effective in patients with low baseline anxiety.Longitudinal assessment of depression, hopelessness, anxiety, and physical and emotional functional limitations in depressed older primary care patients is critical. Patients with prominent symptoms or impairment in these areas may be candidates for care management or mental health care, since they are at risk for remaining depressed and disabled.

Objective Authors evaluated the association between use/dosage of risperidone (RIS) and falls in a residential-care dementia population. Methods Authors performed secondary analysis of data from ambulatory patients in a randomized, double-blind, placebo-controlled, 12-week trial of three RIS dosages (0.5 mg/day, 1 mg/day, 2 mg/day). Outcomes included number of fallers, rate of falls, and time until the first fall after randomization. Additional analyses evaluated wandering as a potential moderating or mediating variable. Results The ambulatory sample included 537 subjects. Of those, 22.3% on placebo, 18.0% on RIS 0.5 mg/day, 12.7% on 1 mg/day, and 27.3% on 2 mg/day, respectively, fell during the trial. The difference between the RIS 1 mg/day group and placebo was significant, with a significantly lower hazard ratio in the RIS 1-mg/day group than placebo. Wandering was associated with an increased risk of falls. Among 205 patients with the highest levels of wandering at baseline, RIS 1 mg/day was associated with approximately a 70% reduction in risk for falls versus placebo condition. However, in those with the lowest levels of wandering at baseline, RIS 2 mg/day may have increased the risk of falls. Conclusions Evaluating the benefits versus risks of risperidone in patients with dementia is complex and must consider multiple outcomes as a function of dose. At 1 mg/day, RIS was associated with decreased falls, especially in patients who exhibit wandering. However, at 2 mg/day, it may increase the risk of falls in ambulatory individuals with low levels of wandering.

Objectives: To examine the effect of depression and other nonmotor symptoms on functional ability in Parkinson's disease (PD). Design: A cross-sectional study of a convenience sample of PD patients receiving specialty care. Setting: The Parkinson's Disease Research, Education and Clinical Center at the Philadelphia Veterans Affairs Medical Center. Participants: One hundred fourteen community-dwelling patients with idiopathic PD. Measurements: The Unified Parkinson's Disease Rating Scale (UPDRS); Hoehn and Yahr Stage; Mini-Mental State Examination; Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, depression module; probes for psychotic symptoms; Hamilton Depression Rating Scale; Geriatric Depression Scale—Short Form; Apathy Scale; and Epworth Sleepiness Scale. Disability was rated using the UPDRS activity of daily living (ADL) score and the Schwab and England ADL score. Multivariate analysis determined effect of depression and other nonmotor symptoms on disability. Results: The presence of psychosis, depressive disorder, increasing depression severity, age, duration of PD, cognitive impairment, apathy, sleepiness, motor impairment, and percentage of time with dyskinesias were related to greater disability in bivariate analyses. Entering these factors into two multiple regression analyses, only the increasing severity of depression and worsening cognition were associated with greater disability using the UPDRS ADL score, accounting for 37% of the variance in disability (P

Summary: PROSPECT (Prevention of Suicide in Primary care Elderly—Collaborative Trial) is testing whether a trained clinician (the ‘health specialist’) can work in close collaboration with a primary care physician to implement a comprehensive depression management program and improve outcomes in older depressed patients. An algorithm guiding the selection and use of antidepressant medications has been developed to assist PROSPECT health specialists. This algorithm is presented and the rationale underlying the proposed treatment sequence is discussed. The PROSPECT algorithm builds upon existing guidelines after updating them and adapting them to the special circumstances of older primary care patients. Special attention has been paid to the tolerability and the target doses of the recommended antidepressant agents and to the duration of antidepressant trials. Patients who are unable to tolerate or do not respond to an antidepressant can be switched to another agent or be treated with interpersonal psychothe...

Objective Seeking to enhance nursing home residents' involvement in their care, the authors examined whether the Minimum Data Set, Version 2.0 (MDS) Mood Disturbance items could be administered by self-report. They compared the MDS to the Geriatric Depression Scale (GDS) in terms of its association with depression diagnosis. Methods Subjects (N=204) were nursing home residents who were interviewed with a psychiatric diagnostic instrument, the GDS, and a self-report version of the MDS mood disturbance items. Results Analyses of variance and receiver operating characteristics analyses demonstrated that MDS items distinguished subjects with any versus no depression about as well as did the GDS. This pattern held within cognitive, gender, and ethnicity subgroups. Conclusion The MDS Mood Disturbance items can be reliably and validly administered via self-report to persons scoring at least 12 on the Mini-Mental State Exam.

Recognition of gaps between evidence gained from mental health research and clinical practice in the community together with changes in treatment patterns and patient/provider preferences for care have led to interest in enhancements in the designs and analyses of clinical and community trials of mental health interventions. Gaps between clinical trials and community care include differences in populations and treatment strategies. To bridge these gaps, we propose enhancing the simple randomized trial with several different designs with the immediate aims of improving patient recruitment and adherence in psychiatric intervention studies thus bringing study designs more in line with clinical practice. The goals are to estimate treatment efficacy and effectiveness so that both internal and external validity are optimized. In this discussion, we address design and analytic issues with respect to a number of enhancements of the randomized trial design, including partial patient-provider preference designs, randomized encouragement and consent designs, fixed adaptive design, and random between- and within-patient adaptive designs. Each has advantages and disadvantages depending on the effect under investigation. Some of these enhancements, such as the fixed adaptive design, have begun to be implemented in effectiveness trials in mental health services research, but all are worthy of more attention.

This review centers on the development of diagnostic criteria for depression of Alzheimer's disease. It describes: risk-factors and neurobiological correlates, epidemiology, clinical characteristics and course, assessment, treatment, economics, a description of the criteria and future research directions. Overall, there is substantial evidence for depression of Alzheimer's disease. Further research is needed to better define core symptoms, clinical course and efficacy of treatments.

The relationships between military service and suicide are not clear, and comparatively little is known about the characteristics and correlates of suicide ideation and attempts among those with history of military service. We used data from a national health survey to estimate the prevalence and correlates of suicidal behaviors among veterans and service members in 2 states. The prevalence of suicidal behaviors among Veterans was similar to previous estimates of ideation and attempts among adults in the US general population.

This study characterizes those patients of an urban VA Medical Center (VAMC) who had committed suicide. A cause-of-death search of the 1,075 veterans from the VAMC's case rolls who died during 1998 was conducted. For confirmed and suspected suicides, a chart review was conducted, noting psychiatric history and recent contact with the VAMC. Nineteen patients were either confirmed or suspected suicides. Few of these patients had made recent contact with the VAMC, although the majority of them had received psychiatric services from the VA at some time. The proportion of deaths due to suicide was similar in African American and White patients. Rates of suicide were elevated, primarily because of the high proportion of patients receiving psychiatric treatment. Elderly suicides were less likely to have had psychiatric services or previous psychiatric diagnoses than were younger suicides. Patients with past contact with psychiatric services may be especially at risk of suicide, particularly as contact with these services diminishes. Elderly patients in medical settings with undiagnosed or undertreated psychiatric disorders are also likely to have elevated risk for suicide. These findings demonstrate the importance of acknowledging that risk factors for suicide are specific to sites or populations; this information can be used in allocating resources for developing site-specific strategies for prevention.

OBJECTIVES: Previous studies have demonstrated an association between major depression and physical disability in late life. The objectives of this study were to examine the relationship between specific medical illnesses and the outcomes of treatment for late-life depression. DESIGN: The study was a longitudinal assessment of medical illness, depression, and disability. Patients were assessed during an initial inpatient psychiatric hospitalization and 3 months postdischarge. SETTING: All patients were initially evaluated after admission to one of 71 inpatient psychiatric treatment facilities. PARTICIPANTS: A sample of 671 older patients who received inpatient treatment for depression was evaluated at entry into the hospital and 3 months after discharge. MEASUREMENTS: Depressive symptoms were measured using the Geriatric Depression Scale. Disability was measured using the instrumental activities of daily living scale and the Medical Outcomes Study 36-item short form. Medical illness was assessed using the medical illness checklist. RESULTS: As previously reported, physical disability and the total number of medical illnesses were significantly related to change in depressive symptoms. In this study, we find that arthritis, circulatory problems, a speech disorder, or a skin problem, but not other general medical conditions, were related to a worse outcome with respect to depression symptoms. The effect of these problems was statistically and clinically significant. After controlling for pretreatment disability, arthritis and skin problems continued to predict a worse outcome. However, the apparent effect of each of these conditions was mediated by the residual disability after treatment. CONCLUSION: The results of this study support the hypothesis that certain somatic disorders play a role in the treatment response of late-life depression and suggest that the effect of specific illnesses on depression may be mediated by the presence of functional disability.

A number of studies, using different research designs and assessment instruments, have been conducted to elucidate the differential effects of drug treatments for psychosis, agitation and aggression in elderly patients with dementia. We have reviewed literature published from 1960 to 2000 on this topic; 48 studies that met our selection criteria were identified from Medline and Science Citation Index. Antipsychotic medication was generally effective for the treatment of psychosis and agitation in elderly patients with dementia. In double-blind, placebo-controlled trials in this population, mean improvement rates were 61% with antipsychotics and 35% with placebo. Atypical antipsychotics appeared promising, but the number of well-designed studies has been small so far. Methodological limitations of the studies reviewed are discussed; future trials should ensure adequate sample size and duration and involve direct comparisons of individual medications. In conclusion, conventional antipsychotics are modestly effective for treatment of psychosis and agitation in elderly individuals with dementia, whereas newer treatments such as atypical antipsychotics appear to be at least as effective while having fewer adverse effects. Nonetheless, there is no currently available ideal pharmacotherapy, and psychosocial management is a necessary part of overall treatment. Additional large-scale, well-controlled studies are needed before conclusive statements regarding the value of treatment of psychosis and agitation with atypical antipsychotics and non-antipsychotic agents can be made.

OBJECTIVES: To evaluate the safety and efficacy of donepezil in the management of patients with Alzheimer's disease (AD) residing in nursing home facilities. DESIGN: Twenty-four-week, randomized, multicenter, parallel-group, double-blind, placebo-controlled trial. SETTING: Twenty-seven nursing homes across the United States. PARTICIPANTS: Two hundred eight nursing home patients with a diagnosis of probable or possible AD, or AD with cerebrovascular disease; mean Mini-Mental State Examination (MMSE) score 14.4; mean age 85.7. MEASUREMENTS: The primary outcome measure was the Neuropsychiatric Inventory—Nursing Home Version (NPI-NH). Secondary efficacy measures were the Clinical Dementia Rating (Nursing Home Version)—Sum of the Boxes (CDR-SB), MMSE, and the Physical Self-Maintenance Scale (PSMS). Safety was monitored by physical examinations, vital signs, clinical laboratory tests, electrocardiograms (ECGs), and treatment-emergent adverse events (AEs). RESULTS: Eighty-two percent of donepezil- and 74% of placebo-treated patients completed the trial. Eleven percent of donepezil- and 18% of placebo-treated patients withdrew because of AEs. Mean NPI-NH 12-item total scores improved relative to baseline for both groups, with no significant differences observed between the groups at any assessment. Mean change from baseline CDR-SB total score improved significantly with donepezil compared with placebo at Week 24 (P < .05). The change in CDR-SB total score was not influenced by age. Differences in mean change from baseline on the MMSE favored donepezil over placebo at Weeks 8, 16, and 20 (P < .05). No significant differences were observed between the groups on the PSMS. Overall rates of occurrence and severity of AEs were similar between the two groups (97% placebo, 96% donepezil). Gastrointestinal AEs occurred more frequently in donepezil-treated patients. In general, AEs were similar in older and younger donepezil-treated patients, with the majority of patients experiencing only AEs that were transient and mild or moderate in severity. Weight loss was reported as an AE more frequently in older patients, although a loss at last visit of ≥7% of screening weight occurred at the same rate in older and younger patients (9% of donepezil- and 6% of placebo-treated patients). No significant differences between groups in vital sign changes, bradycardia, or rates of clinically significant laboratory or ECG abnormalities were observed. CONCLUSION: Patients treated with donepezil maintained or improved in cognition and overall dementia severity in contrast to placebo-treated patients who declined during the 6-month treatment period. The safety and tolerability profile was comparable with that reported in outpatient studies of donepezil. These findings also suggest that advanced age, comorbid illnesses, and high concomitant medication usage should not be barriers to donepezil treatment. Given the apparent improvement in behavior in the placebo group, and the high use of concomitant medications in both groups, the impact of donepezil on behavior in the nursing home setting is unresolved and merits further investigation. In summary, effects on cognition, overall dementia severity, and safety and tolerability findings are consistent with previous findings in outpatients and support the use of donepezil in patients with AD who reside in nursing homes.

The authors describe the development of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) protocol for Alzheimer disease (AD), a trial developed in collaboration with the National Institute of Mental Health (NIMH), assessing the effectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented.

Why focus on the delivery of treatment for late life depression in the primary care setting? Because depression can be a risk factor as well as a complication of many of the chronic diseases of late life, and because it is associated with increased suffering, medical morbidity, and disability.' Moreover, older patients are less likely to seek or accept care from mental health specialists, but the treatments delivered by primary care providers are, most often, inadequate. The past decade of research on strategies to close the gap between the efficacy of treatment achieved in clinical trials and the effectiveness achieved in routine care has