Lithium Treatment in the Prevention of Repeat Suicide-Related Outcomes in Veterans With Major Depression or Bipolar Disorder: A Randomized Clinical Trial.

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.

Practitioner-level determinants of inappropriate prostate-specific antigen screening.

BACKGROUND: None of the major clinical practice guidelines recommend that prostate-specific antigen (PSA) screening be routinely performed in asymptomatic men older than 75 years or younger than 40 years. We investigated the practitioner-level determinants of inappropriate PSA screening in 7 Veterans Health Administration (VHA) hospitals. METHODS: Data on PSA test use from 1997 to 2004 were obtained from VHA databases for 181 139 male patients and the 4823 health care providers who ordered their tests. Patients were excluded from the study population if they underwent PSA testing for nonscreening reasons, as indicated by prostate cancer-specific medications, diagnoses, and procedures. Inappropriate PSA test use was defined as PSA screening in patients older than 75 years or younger than 40 years. Univariate and multivariate Poisson regressions were performed. RESULTS: The mean +/- SD percentage of inappropriate tests by health care provider was 19.3% +/- 15.0%, with 18.4% +/- 14.9% in patients older than 75 years and 0.8% +/- 3.0% in patients younger than 40 years. Practitioners who were urology specialists, male, infrequent PSA test orderers, and affiliated with specific hospitals had significantly higher levels of inappropriate PSA screening. Compared with attending physicians, nurses and physician assistants had significantly lower levels of inappropriate screening. Under multivariate modeling, infrequent PSA test ordering and hospital affiliation retained statistical significance. The percentage of inappropriate PSA screening increased significantly with the age of male health care providers (P<.001). CONCLUSIONS: This study elucidates several important provider-level determinants of PSA screening misuse and substantiates that PSA screening is frequently performed counter to evidence-based guidelines. Further work is needed to determine the degree to which "prostatempathy" contributes to PSA misuse by older male providers.

Randomized controlled trial of prophylactic repair of hemodialysis arteriovenous graft stenosis.

BACKGROUND: Previous nonrandomized studies suggest that prophylactic repair of hemodialyisis arteriovenous (AV) graft stenosis reduces thrombosis rates and increases cumulative graft survival. The present study is a randomized trial comparing prophylactic repair of AV graft stenosis with repair at the time of thrombosis. METHODS: Sixty-four patients with elevated static venous pressure measured in an upper extremity AV graft were randomized to Intervention or Observation. Monthly static venous pressure/systolic blood pressure ratios (SVPR) were determined for all patients throughout the duration of study participation. Patients in the Intervention group underwent angiography and repair of identified stenoses if the monthly SVPR was elevated (>/=0.4). Patients in the Observation group underwent stenosis repair only in the event of access thrombosis or clinical evidence of access dysfunction. The primary end point was access abandonment. RESULTS: Access abandonment occurred in 14 patients in the Intervention group and 14 patients in the Observation group during the 3.5-year study period. Time to access abandonment did not differ significantly between the treatment groups (hazard ratio for randomization to Intervention 1.75, 95% CI 0.80-3.82, P= 0.16). The proportion of patients with a thrombotic event was greater in the Observation group (72%) than in the Intervention group (44%) (P= 0.04), but overall thrombosis rates were similar in the groups. CONCLUSION: Compared with a strategy of observation and repair of accesses only in the event of thrombosis, prospective static venous pressure monitoring with prophylactic stenosis repair did not prolong graft survival.

Value of static venous pressure for predicting arteriovenous graft thrombosis.

BACKGROUND: Static venous pressure elevation has been shown to have both high sensitivity and high specificity for hemodialysis arteriovenous (AV) graft venous anastomosis stenosis. However, it is not known how well static venous pressure elevation predicts subsequent AV graft thrombosis. METHODS: Monthly static venous pressure measurements were made during two consecutive dialysis sessions in all patients with a functioning upper extremity AV graft in two hemodialysis units during a 16-month period. Static venous pressure was normalized to systolic blood pressure and corrected for the height difference between the AV graft and the dialysis machine pressure transducer to yield the static venous pressure ratio (SVPR). RESULTS: Fifty-four patients (38%) had a thrombotic event during the study period and thus were labeled as clotters. Among the clotters, SVPR just prior to thrombosis was 0.51 +/- 0.16 (mean +/- SD), and mean time to thrombosis following an elevated SVPR (> or =0.4) was 118 +/- 106 days. Receiver operating characteristic (ROC) curves were generated using the sensitivities and specificities of a range of SVPR values for access thrombosis within one, two, three and four months. The areas under the curve (AUCs) for the ROC curves ranged from 0.557 to 0.638, reflecting the absence of SVPR values with both high sensitivity and high specificity for access thrombosis. An increase in SVPR over time was not a better predictor of access thrombosis than absolute SVPR. CONCLUSION: Static venous pressure measurement is not an optimal screening test for identifying AV grafts at risk for thrombosis.