Medical comorbidity and health-related quality of life in bipolar disorder across the adult age span.

BACKGROUND: Little is known about medical comorbidity or health-related quality of life (HRQOL) in bipolar disorder across the adult age span, especially in public sector patients. METHODS: We obtained cross-sectional demographic, clinical, and functional ratings for 330 veterans hospitalized for bipolar disorder with Mini-Mental State score > or = 27 and without active alcohol/substance intoxication or withdrawal, who had had at least 2 prior psychiatric admissions in the last 5 years. Structured medical record review identified current/lifetime comorbid medical conditions. SF-36 Physical (PCS) and Mental (MCS) Component Scores, measured physical and mental HRQOL. Univariate and multivariate analyses addressed main hypotheses that physical and mental function decrease with age with decrements due to increasing medical comorbidity. RESULTS: PCS decreased (worsened) with age; number of current comorbid medical diagnoses, but not age, explained the decline. Older individuals had higher (better) MCS, even without controlling for medical comorbidity. Multivariate analysis indicated association of MCS with age, current depressed/mixed episode, number of past-year depressive episodes, and current anxiety disorder, but not with medical comorbidity, number of past-year manic episodes, current substance disorder or lifetime comorbidities. LIMITATIONS: This cross-sectional design studied a predominantly male hospitalized sample who qualified for and consented to subsequent randomized treatment. CONCLUSIONS: Medical comorbidity is associated with lower (worse) physical HRQOL, independent of age. Surprisingly, younger rather than older subjects reported lower mental HRQOL. This appears due in part to more complex psychiatric presentations, and several mechanisms are discussed. Both results suggest that age-specific assessment and treatment may enhance HRQOL outcome.

The effect of vitreous presentation during extracapsular cataract surgery on the postoperative visual acuity at one year.

PURPOSE: The purpose of this study was to determine the effects that vitreous presentation (VP) during extracapsular cataract surgery has on patients' 1-year postoperative vision. DESIGN: The study was a prospective, long-term, clinical trial. METHODS: The study took place at 19 Department of Veterans Affairs medical centers. Patients having VP during cataract surgery and receiving a posterior chamber (PC) intraocular lens (IOL) (230 patients) were prospectively compared with a 5% random sample of nonvitreous presentation (NVP) cataract surgery patients (521 patients). Best-corrected visual acuity (BCVA) at 1 year was obtained by a masked, certified examiner. RESULTS: There was no statistical difference (P = .089) between the VP patients receiving PC IOL and the NVP patients in percentage of patients having BCVA of 20/40 or better at 1 year (91.1% vs 94.9%). There were significantly more PC IOL VP patients than NVP patients with BCVA of 20/50 or worse at some time during the first postoperative year (21.6% vs 10.9%; P = .0003), significantly fewer with BCVA of 20/20 or better at 1 year (27.8% vs 38.8%; P = .013), and significantly more with cystoid macular edema (11.5% vs 3.6%; P = .0002), retinal detachment (4.3% vs 0.2%; P = .0002), and uveitis (3.4% vs 0.6%; P = .012). The NVP patients rated their vision as very good or excellent significantly more often than the VP patients (71% vs 58%; P = .025). CONCLUSIONS: Vitreous presentation during extracapsular cataract surgery leads to somewhat worse overall outcomes in patients, although the majority of patients with VP do reasonably well.

A comparison of anterior chamber and posterior chamber intraocular lenses after vitreous presentation during cataract surgery: the Department of Veterans Affairs Cooperative Cataract Study.

PURPOSE: To compare the efficacy and safety of anterior chamber (AC) intraocular lenses (IOLs) and posterior chamber (PC) IOLs implanted after vitreous presentation during extracapsular cataract extraction (ECCE). DESIGN: The study was a prospective, long-term, randomized clinical trial conducted at 19 Department of Veterans Affairs medical centers across the United States. METHODS: There were 438 eyes (438 patients) that met preliminary eligibility criteria, suffered vitreous presentation during ECCE (phacoemulsification or classical extracapsular technique), and had sufficient capsular support for a PC IOL without sutures after anterior vitrectomy randomized to either a PC IOL (230 patients) or an AC IOL (208 patients). Patients were examined at 3, 6, and 12 months post-surgery and yearly thereafter. Minimum follow-up was 1 year. The primary outcome measure of best-corrected visual acuity at 1 year was obtained by a masked certified examiner. RESULTS: More PC IOL patients (91%) achieved visual acuity of 20/40 or better at 1 year than AC IOL patients (79%), a highly significant difference (P =.003). There was no significant difference between the two groups for patient's rating of vision or adverse events. Over 84% of the PC IOL patients and over 77% of the AC IOL patients rated their vision as good or better at 1 year as opposed to only 7% giving such ratings before surgery. For at least one rating period during the first year, 13.2% of the combined study patients had cystoid macular edema, 8.5% had posterior capsule opacification, 5.7% had glaucoma, and 3.7% had retinal detachment. CONCLUSION: In the presence of sufficient capsular support, a PC IOL should be implanted after vitreous presentation during ECCE.

Clinical, psychosocial, and treatment differences in minority patients with bipolar disorder.

OBJECTIVES: The clinical profile of minorities with bipolar disorder has been largely unexplored. We compared the clinical (e.g. psychiatric and substance use comorbidity), psychosocial, and treatment characteristics between white and minority patients with bipolar disorder (minorities were defined as black or other minority, which included Hispanic, Asian-American, or Native-Americans). METHODS: We collected demographic, diagnosis, and treatment information using the Structured Clinical Interview for DSM-IV (SCID) from 330 inpatients with a current major affective episode across 11 Veterans Affairs (VA) Medical Centers enrolled in the VA Cooperative Study (Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder). RESULTS: Twenty-four percent (n=80) were minority; 9% (n=30) were women, 4% (n=20) were >or=65 years old; and the majority (87%, n=286) had bipolar type I. Minorities compared with whites were no more likely to have a current episode of psychosis (30% versus 37%, respectively; p=0.28). However, minorities were more likely than whites to have a cocaine use disorder (adjusted odd's ratio, OR=2.2; 95% CI: 1.4-3.5; p<0.01) or current alcohol abuse disorder (adjusted OR=1.8; 95% CI: 1.1-3.9;p<0.05). Further breakdown by race/ethnicity revealed that cocaine use disorder was most prevalent among blacks (n=14, 29%), compared with all other minorities (n=2, 6%) or whites (n=10, 4%; p<0.001). Other minorities compared with blacks or whites were more likely involuntarily committed during some part of their index hospitalization (adjusted OR=2.47; 95% CI: 1.1-5.7; p=0.04). CONCLUSIONS: Minorities with bipolar disorder may be a more vulnerable population because of higher rates of substance use disorder and higher rates of involuntary psychiatric commitment. Moreover, the specific profile of vulnerability may differ across minority groups.

Medication compliance feedback and monitoring in a clinical trial: predictors and outcomes.

OBJECTIVE: The objective of this study was to demonstrate the utility of continuous monitoring and enhancement of medication compliance during a long-term clinical trial, predictors of compliance, and relationships to drinking outcomes. METHODS: Alcohol-dependent patients enrolled in a multicenter VA cooperative study were randomly assigned to once-daily naltrexone (NTX) for 3 or 12 months (short-term or long-term NTX) or placebo for 12 months of treatment. All medications were dispensed in bottles with medication event monitoring (MEMS, AARDEX, Union City, CA) caps with a microprocessor that recorded openings as presumptive doses. Patients were trained to develop personal cues as dosing reminders. Monthly feedback sessions included review of compliance data and cues. RESULTS: There were no significant differences among short-term NTX, long-term NTX, and placebo (209 each) groups in measures of compliance. Overall compliance rates were 71% +/- 31% of doses for the first 13 weeks and 43% +/- 33% of doses over 52 weeks. Some doses were taken during 83% +/- 27% of the first 13 weeks. Higher medication compliance predicted fewer drinks per drinking day (P = .02) throughout follow-up and a lower percentage of drinking days (P = .002 during the first 13 weeks) with no significant effect for treatment group. CONCLUSIONS: The feedback and monitoring programs were important features to demonstrate that lack of treatment effect was not a result of poor compliance. Medication compliance data supported the internal validity of the trial by demonstrating that good compliers had better outcomes, irrespective of treatment with NTX or placebo. The MEMS feedback methodology is feasible for use in multicenter trials.

The role of the data coordinating center in the DIG trial.

The Digitalis Investigation Group (DIG) trial was a large simple trial (LST) begun in 1990 as a collaboration between the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs (VA) Cooperative Studies Program (CSP). Its primary objective was to determine whether digitalis had beneficial, harmful, or no effect on total mortality in patients with congestive heart failure and an ejection fraction < or =0.45. The Perry Point VA CSP Coordinating Center served as the trial's data coordinating center (DCC). The DCC was involved in all phases of the study from planning and design, organization and start-up, and patient recruitment and follow-up through closeout, final analyses, and manuscript preparation. While DCC responsibilities for an LST are basically the same as for other multicenter randomized clinical trials, their size and the inclusion of many inexperienced research sites can add a complexity that the DCC must be prepared to handle from the beginning. This paper describes the role of the DCC in the DIG trial.