Longitudinal investigation of depression outcomes in primary care in six countries: the LIDO study. Functional status, health service use and treatment of people with depressive symptoms.

BACKGROUND: Screening surveys of depressive symptoms were conducted among primary care patients at six sites in different countries. The LIDO Study was designed to assess quality of life and economic correlates of depression and its treatment in culturally diverse primary health care settings. This paper describes: (1) the association between depressive symptoms and functional status, global health-related quality of life (QoL), and use of general health services across different cultural settings; and (2) among subjects with depressive symptoms, the factors associated with recent treatment for depression. METHODS: Subjects aged 18 to 75 were recruited from participating primary care facilities in Be'er Sheva (Israel), Porto Alegre (Brazil), Melbourne (Australia), Barcelona (Spain), St Petersburg (Russian Federation) and Seattle (USA). Depressive symptoms were measured using the CES-D. Also administered were the SF-12, global questions on QoL, selected demographic and social measures, and questions on recent treatment for depression, use of health care services, and lost workdays. RESULTS: A total of 18,489 patients were screened, of whom 37% overall (range 24-55%) scored > or = 16 on the CES-D and 28% (range 17-42%) scored > or = 20. Overall, 13% reported current treatment for depression (range 4 to 23%). Patients with higher depressive symptom scores had worse health, functional status, QoL, and greater use of health services across all sites. Among those with a CES-D score > or = 16, subjects reporting treatment for depression were more likely than those reporting no treatment to be dissatisfied with their health (except in St Petersburg), and to have higher depressive symptom scores. CONCLUSIONS: Higher depressive symptom scores in primary care patients were consistently associated with poorer health, functional status and QoL, and increased health care use, but not with demographic variables. The likelihood of treatment for depression was associated with perceptions of health, as well as severity of the depression.

A review of the health-related quality of life literature in bipolar disorder.

This paper reviews the existing literature on health-related quality of life assessments conducted in bipolar disorder patients, and provides recommendations for the use of specific scales to measure health-related quality of life in this population. A comprehensive review of the literature revealed only a handful of studies in bipolar disorder that had incorporated quality of life assessments. While instruments from the medical outcomes study (MOS) were the most frequently used to measure health-related quality of life, a number of other instruments like the psychological general well being scale (PGWB), the streamlined longitudinal interview clinical evaluation from the longitudinal interval follow-up evaluation (SLICE/LIFE), the Euroqol, (EQ-5D), the Lehman's quality of life interview (QLI), and the quality of life in depression scale (QLDS) were also used. Only three studies out of ten reported the psychometric properties of the measures used. In the absence of a disease-targeted measure, a combination of the SF-36 and the PGWB is presently recommended as the battery of choice to assess the health-related quality of life of individuals with bipolar disorder. There is also the need to develop a disease-targeted health-related quality of life measure for bipolar disorder, which will obviate the use of a burdensome battery of generic quality of life instruments.

Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial.

Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.

Cultural adaptation of a quality-of-life measure for urinary incontinence.

OBJECTIVES: To translate and validate a urinary incontinence-specific measure of quality of life (I-QOL) in French, Spanish, Swedish, and German and provide translations only into seven other languages and variants of these languages. METHODS: Quality of life and linguistic experts prepared two forward translations from American English to their native languages and helped to harmonize these translations at a meeting. In the four European countries, the adapted versions of the I-QOL were administered to 259 women with stress, urge, and mixed incontinence. Principal component analyses were used to confirm the proposed measurement model suggested by patient interviews. Psychometric testing was conducted using standardized procedures. RESULTS: Translation procedures resulted in a change in the original instrument's Likert response scale from 4 to 5 points. Principal component analyses confirmed three patient-derived subscales and higher-order factor analysis confirmed a total summary score. In all countries, the internal consistency (alpha) and reproducibility (ICC) were high (alpha ranged between 0.87 and 0.93); (ICC ranged between 0.92 and 0.95). In all countries, I-QOL scores were significantly worse (p < 0.001) as perceived severity of incontinence, use of services, and number of incontinent episodes increased. CONCLUSIONS: The I-QOL has been adapted successfully into eleven languages and six variants of these languages. The cross-sectional psychometric properties of the US version were confirmed in four European countries. The I-QOL fills the need for a valid, international quality-of-life instrument for incorporation in clinical trials covering patients with varying types and severity of urinary incontinence.

Information needs for medication coverage decisions in a state Medicaid program.

BACKGROUND: Health plans commonly face the conflicting demands of trying to provide access to novel technologies, including new classes of medications, while trying to contain costs. These demands are particularly acute for California's Medicaid program, known as Medi-Cal, which is responsible for delivery of medical care to an unusually large population of mentally ill individuals in the context of a culturally diverse environment. To meet the challenge, Medi-Cal has instituted a formal process for technology assessment of new and existing pharmaceutical products known as the Therapeutic Class Review (TCR). OBJECTIVE: The purpose of this paper is to describe the information produced for Medi-Cal in the TCR process for antidepressant medications and the individual petition review of antipsychotic medications, and to synthesize our experience in a series of policy recommendations designed to improve the quality of coverage decisions. OUTCOME: A collaborative process between Medi-Cal and Lilly resulted in a substantive body of new evidence regarding the needs of Medi-Cal recipients, the quality of current treatment, and prospects regarding the cost-effectiveness of introducing newer treatments. CONCLUSION: Medi-Cal has a formal process for evaluating new medicines. This process allows researchers to understand the needs of those who make coverage decisions. We recommend increasing routine epidemiologic surveillance, including service use, and clinical trials that include aspects of usual medical care early in the drug development process.

SSRI antidepressant drug use patterns in the naturalistic setting: a multivariate analysis.

BACKGROUND: The study of the duration and pattern of antidepressant use in actual clinical practice can provide important insights into how antidepressant prescribing patterns compare with recommended depression treatment guidelines. OBJECTIVE: The purpose of this study, using data available from depressed outpatients in the United States, is to assess the effects of initial SSRI antidepressant selection on the subsequent pattern and duration of antidepressant use. RESEARCH DESIGN: Multiple logistic regression analysis of data from a large prescription and medical claims database (MarketScan) for the years 1993 and 1994 were used to estimate the determinants of antidepressant drug use patterns for 1,034 patients with a "new" episode of antidepressant therapy who were prescribed one of three most often prescribed selective serotonin reuptake inhibitors (SSRIs), paroxetine, sertraline, or fluoxetine. RESULTS: Patients initiating therapy on sertraline or paroxetine were less likely than patients initiating therapy on fluoxetine to have four or more prescriptions of their initial antidepressant within the first 6 months. CONCLUSIONS: The findings suggest that antidepressant selection is an important determinant of the initial duration and pattern of antidepressant use which is consistent with current recommended depression treatment guidelines.

Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL)

OBJECTIVES: To report on the further development of the Incontinence Quality of Life Instrument (I-QOL), a self-report quality of life measure specific to urinary incontinence (UI), including its measurement model, responsiveness, and effect size. METHODS: Incontinent female patients (141 with stress, 147 with mixed UI) completed the I-QOL and comparative measures at screening, pretreatment, and four subsequent follow-up visits during participation in a multicenter, double-blind, placebo-controlled, randomized trial assessing the efficacy of duloxetine. Psychometric testing followed standardized procedures. RESULTS: Factor analysis confirmed an overall score and three subscale scores (avoidance and limiting behaviors, psychosocial impacts, and social embarrassment). All scores were internally consistent (alpha = 0.87 to 0.93) and reproducible (ICC = 0.87 to 0.91). The pattern of previously reported correlations with the Short-Form 36-item Health Survey and Psychological Well-Being Schedule were confirmed. Responsiveness statistics using changes in the independent measures of stress test pad weight, number of incontinent episodes, and patient global impression of improvement ranged from 0.4 to 0.8. Minimally important changes ranged from 2% to 5% in association with these measures and effect sizes. CONCLUSIONS: In a clinical trial, the I-QOL proved to be valid, reproducible, and responsive to treatment for UI in women.

The application of sample selection models to outcomes research: the case of evaluating the effects of antidepressant therapy on resource utilization.

Non-randomized studies of treatment effects have come under criticism because of their failure to control for potential biases introduced by unobserved variables correlated with treatment selection and outcomes. This paper describes the basic concepts of sample selection models--a technique used widely in the economics evaluation literature for nearly two decades--and discusses the potential role of these models in outcomes research. In addition, it presents a case study of the application of the sample selection modelling approach to evaluation of the effects of antidepressant therapies on medical expenditures for physician services. This case study presents empirical comparisons of alternative model specifications and discusses practical issues in evaluation of sample selection models. We demonstrate that, in this particular case, sample selection models yield very different conclusions regarding treatment effects than traditional ordinary least squares regression.

Health state preferences of persons with anxiety.

We compared patient ratings of the desirability of anxiety health states with measures of psychological distress and functional status and investigated how these ratings predicted treatment by primary care and mental health clinicians. As expected, associations between desirability ratings and psychological and physical health status were low to moderate. Persons who rated their current anxiety health state as more desirable received fewer mental health referrals and were statistically more likely to receive a prescription for psychotropic medication. Simple ratings of health state desirability may help clinicians evaluate patients' views of their health status and discuss potential treatment options.

Health economic evaluations of antidepressants: a review.

In an era of constrained health care financing, clinicians are increasingly faced with considering the economic consequences in addition to the clinical outcomes associated with initiating a patient on antidepressant therapy. This has increased the demand for health economic studies comparing antidepressant use and associated health care expenditures in clinical practice. These health economics studies have used methods ranging from clinical trials to other types of analyses including prospective naturalistic trials or retrospective studies which may be less familiar to clinicians. Prospective and retrospective health economics studies performed in clinical practice complement the experience gained from clinical trials in assessing antidepressant use and economic outcomes in light of patient and provider behavior within the usual care environment of a complex health care system. Broadly considered, health economic studies of antidepressants have consistently found differences in clinical practice between the tricyclic antidepressants (TCAs) and the selective serotonin reuptake inhibitors (SSRIs) as well as among the SSRIs. These differences relate to the pattern and duration of antidepressant use as well as total direct health care expenditures. Future health economic research studies in clinical practice should focus on the economic consequences of long-term antidepressant use as well as the impact of antidepressant use on indirect costs such as productivity and absenteeism.

Tricyclic antidepressant and selective serotonin reuptake inhibitors antidepressant selection and health care costs in the naturalistic setting: a multivariate analysis.

BACKGROUND: Providers and payers have an interest in the total health care costs following the initiation of antidepressant treatment in the real world of clinical practice. Analyses of these costs can help evaluate the economic consequences of patient management decisions associated with initial antidepressant selection. OBJECTIVE: The purpose of this study was to assess the 1-year total direct health care costs for patients initiating therapy with one of the available tricyclic antidepressants (TCAs) or one of the three most often prescribed selective serotonin reuptake inhibitors (SSRIs) - paroxetine, sertraline, or fluoxetine. METHOD: A two-stage multivariate econometric model and data from fee-for-service private insurance claims between 1990 and 1994 were used to estimate the total direct health care costs following initial antidepressant drug selection for 2693 patients with a 'new' episode of antidepressant treatment. After controlling for both observed and unobserved characteristics, the 1-year total direct health care costs were found to be (1) statistically significantly lower for patients initiating therapy on fluoxetine than for patients initiating therapy on a TCA; (2) statistically significantly lower for patients who initiated therapy on fluoxetine than for patients initiating therapy on sertraline. CONCLUSIONS: Broadly considered, the findings in this study suggest that total direct health care costs differ across initial antidepressant selection after controlling for both observed and unobserved characteristics.

Effect of antidepressant therapy on health care utilization and costs in primary care.

OBJECTIVE: Four groups of patients receiving different antidepressant drugs in a primary care setting were compared in terms of duration of antidepressant therapy and health and mental health care utilization and costs. METHODS: A retrospective analysis of the medical and pharmacy claims of an employed population and their families was conducted. A total of 1,242 patients with a diagnosis of depression were included in the analyses. The four antidepressant cohorts were fluoxetine (N = 799), trazodone (N = 89), the tricyclics amitriptyline and imipramine (N = 104), and the secondary amine tricyclics desipramine and nortriptyline (N = 250). The primary outcome measures were total health care charges, total charges for mental health services, and the pattern of antidepressant use. Secondary measures included charges for outpatient care and pharmacy and the number of outpatient visits. Data analysis involved use of two-stage multivariate regression modeling known as sample selection models. RESULTS: Patients taking fluoxetine achieved higher rates of continuous use for at least six months compared with those taking the other drugs. After selection bias due to observed and unobserved characteristics and other confounding variables was adjusted for, no significant differences were found between drug cohorts in total medical charges. CONCLUSIONS: Improvements in the process of care at no apparent increase in total charges appear possible through appropriate medication therapy.

Bootstrap analyses of cost effectiveness in antidepressant pharmacotherapy.

In this study, we describe 'bootstrap' methodology for placing statistical confidence limits around an incremental cost effectiveness ratio (ICER). This approach was applied to a retrospective study of annual charges for patients undergoing pharmacotherapy for depression. We used MarketScanSM (service mark) data from 1990 to 1992, which includes medical and pharmacy claims for a privately insured group of employed individuals and their families in the US. Our primary effectiveness measure was the proportion of patients who remained stable on their initial antidepressant medication for at least 6 consecutive months. Our primary cost measure was the total annual charge incurred by patients taking the selective serotonin reuptake inhibitor fluoxetine, a tricyclic antidepressant or a heterocyclic antidepressant. On average, fluoxetine pharmacotherapy tended to decrease annual charges by $US16.48 per patient for each percentage increase in depressed patients remaining stable on initial pharmacotherapy for 6 months, resulting in a negative ICER point-estimate. However, the upper ICER confidence limit is positive, which means that fluoxetine treatment may possibly increase annual per patient charges. With 95% confidence, any such increase was no more than $US130 per patient for each percentage increase in patients remaining stable on initial pharmacotherapy for at least 6 months. One advantage of using a bootstrap approach to ICER analysis is that it does not require restrictive distributional assumptions about cost and outcome measures. Bootstrapping also yields a dramatic graphical display of the variability in cost and effectiveness outcomes that result when a study is literally 'redone' hundreds of times. This graphic also displays the ICER confidence interval as a 'wedge-shaped' region on the cost-effectiveness plane. In fact, bootstrapping is easier to explain and appreciate than the elaborate calculations and approximations otherwise involved in ICER estimation. Our discussion addresses key technical questions, such as the role of logarithmic transformation in symmetrising highly skewed cost distributions. We hope that our discussion contributes to a dialogue, leading ultimately to a consensus on analysis of ICERs.

The functioning and well-being of patients with unrecognized anxiety disorders and major depressive disorder.

This study examines the degree to which untreated anxiety disorders and major depressive disorder, occurring either singly or in combination, reduce functioning and well-being among primary care patients. Adult patients were screened using the SCL-52 to identify those with clinically significant anxiety symptoms. They also completed the Rand Short-Form (SF-36) to measure self-reported patient functioning and well-being. Patients with untreated disorders were identified using the Q-DIS-III-R to diagnose six DIS-anxiety disorders (generalized anxiety disorder, post-traumatic stress disorder (PTSD), simple phobia, social phobia, panic/agoraphobia, obsessive/compulsive disorder) and major depression. Of 319 patients identified, 137 (43%) had a single disorder and 182 (57%) had multiple disorders. Regression models estimated the relative effects of these disorders on health status (SF-36) by comparing patients with the disorders to patients screened as being not-anxious. Estimates of these effects were consistent with available national norms. The estimated effect of each single disorder on all subscales for physical, social and emotional functioning was negative, often as much as a 20-30 point reduction on this 100-point scale. Major depression had the greatest negative impact, followed by PTSD and panic/ agoraphobia. For patients with multiple disorders, the presence of major depression was associated with the greatest reduction in functioning status. The impact of untreated anxiety disorders and major depressive disorder on functioning was comparable to, or greater than, the effects of medical conditions such as low back pain, arthritis, diabetes and heart disease.

The mental health patient profile: does it change primary care physicians' practice patterns?

BACKGROUND: We conducted a prospective trial randomizing 75 physicians to either a control or intervention arm to evaluate the impact of providing patient-reported information on anxiety and other mental health symptoms and disorders to primary care physicians. METHODS: Five hundred seventy-three patients of the study physicians who met entry criteria were randomized to either usual care or usual care supplemented with feedback of patient-reported mental health information to physicians. This mental health information was derived from initial patient-reported questionnaires completed in waiting rooms of physicians contracted to a mixed-model health maintenance organization in Colorado. Main outcome measures included impact of intervention on rates of (1) chart notation of anxiety, depression, or other mental health diagnoses or symptoms; (2) referral to mental health specialists; (3) prescription of psychotropic medications; (4) hospitalization; and (5) office visits during a 5-month observation period. RESULTS: Physicians receiving feedback on previously unrecognized and untreated anxiety patients were more likely to make chart notations (adjusted odds ratio [AOR] = 2.51, 95 percent confidence interval [CI] = 1.62-3.87), to make referrals to mental health specialists (AOR = 3.86, 95 percent CI = 1.63-9.16), and to see patients for more frequent outpatient visits (AOR = 1.73, 95 percent CI = 1.11-2.70). Use of psychotropic medications and rate of hospitalizations did not differ significantly. CONCLUSIONS: Providing patient-reported mental health information to primary care physicians resulted in increased recognition and referral rates for previously unrecognized and untreated anxiety patients, plus an increase in primary care visits, without concomitant increases in the use of psychotropic medications or rate of hospitalizations.

The impact on unemployment of an intervention to increase recognition of previously untreated anxiety among primary care physicians.

Anxiety is a common, though often unrecognized, problem in primary care settings. This study examines the effect on employment of an intervention designed to attune primary care physicians to previously unrecognized and untreated anxiety. Primary care physicians in a mixed-model health maintenance organization (HMO) were randomized by practice site to groups with (intervention) and without (usual care) intensive one-on-one education about anxiety and periodic feedback about their patients with anxiety. All persons 21-65 years of age presenting to the offices of these primary care providers were screened for anxiety with the SCL-90-R on two occasions. Those meeting the SCL-90-R cutpoints for anxiety and whose medical records provided no evidence of recognition or treatment for a mental health condition within the last 6 months were eligible for the study (n = 637). Of these, 573 (90%) completed two follow-up assessments. The present study evaluates the impact of the intervention aimed at the primary care physicians on the labor force participation rate of the persons with anxiety after 5 months of follow-up. The study also evaluates the impact of the intervention on hours of work and the presence of days spent in bed among the persons with anxiety working at the baseline interview and after 5 months. At baseline, the patients of intervention and usual care physicians with previously unrecognized and untreated anxiety did not differ in labor force participation rates. At the conclusion of the study, the patients of the intervention group physicians had significantly lower rates of labor force participation than those of the usual care group physicians. Among those working both at the beginning and conclusion of the study, the intervention had no impact on hours of work or the presence of days spent in bed. We conclude that attuning physicians may reduce labor force participation rates.

Quality of life of persons with urinary incontinence: development of a new measure.

OBJECTIVES: Our objective was to develop a self-report quality of life measure specific to urinary incontinence (I-QOL) that could be used as an outcome measure in clinical trials and in patient care centers. METHODS: The I-QOL was developed from interviews of 20 individuals with urinary incontinence. Refining the questionnaire was accomplished by structured interviews of 17 individuals with urinary incontinence. Testing the I-QOL's psychometric properties involved two administrations (n = 62) along with measures of psychologic well-being and functional status. RESULTS: The rigorous development process ensured that the measure was complete and understandable. The I-QOL proved to be internally consistent (alpha 0.95) and highly reproducible (r = 0.93; 18 days; SD 4). For discriminant validity, severity of incontinence (P < 0.0001) and number of medical appointments in the past year to treat incontinence (P < 0.0001) significantly predicted I-QOL scores. Convergent validity analyses confirmed our predictions that the I-QOL scores were more closely related to overall well-being than bodily pain. CONCLUSIONS: The I-QOL proved to be valid and reproducible as a self-administered measure for assessing quality of life of patients with urinary incontinence.

Antidepressant pharmacotherapy: economic evaluation of fluoxetine, paroxetine and sertraline in a health maintenance organization.

The present study was designed to compare direct health service expenditures, for the treatment of depression, among patients enrolled in a health maintenance organization, and prescribed one of three selective serotonin reuptake inhibitors, fluoxetine, paroxetine or sertraline. Information regarding depression-related health service use was derived from the computer archive of a network-model health maintenance organization system serving 700,000 beneficiaries. A total of 744 health maintenance organization beneficiaries were found to satisfy the study selection criteria. Multivariate regression analysis was used to determine the incremental influence of selected demographic, clinical, financial and provider characteristics on health service expenditures related to the treatment of depression (ICD-9-CM, or DSM-IV code 296.2) 1 year after the start of antidepressant pharmacotherapy. Multivariate findings indicate that treatment with paroxetine increases average expenditures for physician visits ($31.93; P < or = 0.05), psychiatric visits ($19.33; NS), laboratory tests ($2.35; P < or = 0.05), hospitalizations ($85.33; P < or = 0.05), psychiatric hospitalizations ($82.01; P < or = 0.05), and antidepressant pharmacotherapy ($63.72; P < or = 0.05), for a total per capita increase in health service use of $284.68 (P < or = 0.05), compared with treatment with fluoxetine. Sertraline treatment increases average expenditures for physician visits ($21.74; P < or = 0.05), psychiatric visits ($56.79; P < or = 0.05), laboratory tests ($1.21; P < or = 0.05), hospitalizations ($70.59; P < or = 0.05), psychiatric hospitalizations ($95.75; P < or = 0.05), and antidepressant pharmacotherapy ($69.85; P < or = 0.05), for a total per capita increase in health service use of $315.96 (P < or = 0.05), compared with treatment with fluoxetine. Economic comparisons between paroxetine and sertraline did not demonstrate any significant differences in expenditures for the health services examined.

Sleep problems and their correlates in a working population.

OBJECTIVE: To measure the prevalence of sleep problems in a working population and examine their association with health problems, health-related quality-of-life measures, work-related problems, and medical expenditures. Also, to explore the usefulness of a sleep-problems screen for mental health conditions and underlying sleep disorders. DESIGN: Cross-sectional survey administered via voice mail and telephone interview. SETTING: A San Francisco Bay Area telecommunications firm. PARTICIPANTS: Volunteer sample of 588 employees who worked for a minimum of six months at the company and were enrolled in its fee-for-service health plan. MEASUREMENTS AND MAIN RESULTS: Thirty percent of respondents reported currently experiencing sleep problems and were found to have worse functioning and well-being (general health, cognitive functioning, energy), more work-related problems (decreased job performance and lower satisfaction, increased absenteeism), and a greater likelihood of comorbid physical and mental health conditions than were the respondents who did not have sleep problems. They also demonstrated a trend toward higher medical expenditures. CONCLUSIONS: Self-perceived sleep problems were common among the respondents and were associated with poorer health and health-related quality of life. A single question about sleep problems may serve as an effective screen for identifying primary care patients with mental health problems, as well as underlying sleep disorders.

Necessary but not sufficient: the effect of screening and feedback on outcomes of primary care patients with untreated anxiety.

OBJECTIVE: To consider the impact on primary care patient outcomes of using both a screener to determine elevated anxiety levels among patients with previously undetected anxiety and a physician intervention to inform physicians of their patients' conditions. DESIGN: Participating physicians were randomized to either the demonstration or the control arm, and patients were assigned to a study arm based on the randomization of their physicians. The patients were followed for change in outcome measures during the five-month study period. SETTING: A mixed-model health maintenance organization serving approximately 110,000 enrollees in central Colorado. PATIENTS/PARTICIPANTS: 573 patients who had unrecognized and untreated anxiety identified from the approximately 8,000 patients who completed the waiting room screening questionnaire. INTERVENTIONS: A physician intervention served the dual function of 1) providing an educational demonstration of anxiety in the primary care setting and 2) providing a reporting system for summarizing the anxiety symptom levels and functioning status of the patients enrolled in the study. MEASUREMENTS AND MAIN RESULTS: Patient outcomes were measured as changes in global anxiety scores, functioning and well-being, and patients' reports of global improvements. CONCLUSIONS: The findings indicate that this method of reporting symptoms and functioning status to primary care physicians did not significantly change patient outcomes. Improvement in outcomes appeared to be more closely associated with the patient's severity of psychological distress.