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Dennis Revicki

Publications and source records attributed to Dennis Revicki.

14 recordsLinked to original sources
PubMed2006

Impact of PTSD comorbidity on one-year outcomes in a depression trial.

Low-income African American, Latino, and White women were screened and recruited for a depression treatment trial in social service and family planning settings. Those meeting full criteria for major depression (MDD; N = 267) were randomized to cognitive-behavior therapy (CBT), antidepressant medication, or community mental health referral. All randomly assigned participants were evaluated by baseline telephone and clinical interview, and followed by telephone for one year. Posttraumatic stress disorder (PTSD) comorbidity was assessed at baseline and one-year follow-up in a clinical interview. At baseline, 33% of the depressed women had current comorbid PTSD. These participants had more exposure to assaultive violence, had higher levels of depression and anxiety, and were more functionally impaired than women with depression alone. Depression in both groups improved over the course of one year, but the PTSD subgroup remained more impaired throughout the one-year follow-up period. Thus, evidence-based treatments (antidepressant medication or structured psychotherapy) decrease depression regardless of PTSD comorbidity, but women with PTSD were more distressed and impaired throughout. Including direct treatment of PTSD associated with interpersonal violence may be more effective in alleviating depression in those with both diagnoses.

Adult↗
PubMed2006

One-year outcomes of a randomized clinical trial treating depression in low-income minority women.

This study examines 1-year depressive symptom and functional outcomes of 267 predominantly lowincome, young minority women randomly assigned to antidepressant medication, group or individual cognitive- behavioral therapy (CBT), or community referral. Seventy-six percent assigned to medications received 9 or more weeks of guideline-concordant doses of medications; 36% assigned to psychotherapy received 6 or more CBT sessions. Intent-to-treat, repeated measures analyses revealed that medication (p=.001) and CBT (p=.02) were superior to community referral in lowering depressive symptoms across 1-year follow-up. At Month 12, 50.9% assigned to antidepressants, 56.9% assigned to CBT, and 37.1% assigned to community referral were no longer clinically depressed. These findings suggest that both antidepressant medications and CBT result in clinically significant decreases in depression for low-income minority women.

Adult↗
PubMed2005

Psychometric evaluation of the Readiness for Discharge Questionnaire.

OBJECTIVE: The Readiness for Discharge Questionnaire (RDQ) was developed as an easy to use tool for assessing readiness for discharge, independent of socio-economic factors, for inpatients with schizophrenia. The psychometric properties of the RDQ are described. METHODS: The RDQ consists of 6 items assessing suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, delusions/hallucinations interfering with functioning and global status. A final yes/no question assesses readiness for discharge. Data derived from 3 studies (500 patients in 3 countries) were used in analyzing inter-rater and test-retest reliability, content and construct validity, and sensitivity to change. RESULTS: The inter-rater reliability was high for all items of the RDQ (reliability coefficients >0.9) and moderate to high for the readiness for discharge status (Session I: 84% agreement, kappa 0.39, polychoric correlation r=0.81; Session II: 89% agreement, kappa 0.63, polychoric correlation r=0.81. Test-retest reliability was also high for all items of the RDQ (reliability coefficients >0.9) and the readiness for discharge status (kappa=0.743; tetrachoric correlation r=0.819). Overall, 84% of the raters agreed (mean score=5.0 of possible 6.0) that the RDQ was useful in assessing a patient's readiness for discharge from the hospital. Evidence of good construct validity included significant correlations with PANSS total and factor scores, and a significant relationship with actual discharge. Significantly more patients with symptom improvement were judged ready for discharge (compared to those without symptom improvement), indicating that the RDQ was sensitive to change over time. CONCLUSIONS: The RDQ has favorable reliability and validity properties, and is an easy to use instrument in research studies for assessing readiness for discharge of inpatients with schizophrenia. Additional work in naturalistic settings is required to further validate the instrument for routine clinical use.

Activities of Daily Living↗
PubMed2005

Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment.

Hepatitis C virus (HCV) diminishes health related quality of life (HRQOL), and it is now common to measure HRQOL in clinical trials. We sought to summarize the HRQOL data in HCV, and to establish the minimally clinically important difference (MCID) in HRQOL scores in HCV. We performed a systematic review to identify relevant studies, and converted HRQOL data from each study into clinically interpretable statistics. An expert panel used a modified Delphi technique to estimate the MCID in HCV. We found that patients with HCV scored lower than controls across all scales of the SF-36. Patients achieving sustained virological response (SVR) scored higher across all scales versus patients without SVR, especially in the physical health domains. HRQOL differences did not correspond with differences in liver histology or ALT levels. Based upon the published data, the expert panel concluded that the SF-36 vitality scale was most relevant in patients with HCV, and generated a mean MCID of 4.2 points on this scale. In conclusion, patients with HCV have a clinically significant decrement in HRQOL versus controls, and physical HRQOL improves in patients achieving SVR but not in those without SVR. The data further suggest that traditional outcomes fail to capture the full spectrum of illness related to chronic HCV. A difference of 4.2 points on the SF-36 vitality scale can be used as an estimate of the MCID in HCV, and this value may be used as the basis for power calculations in clinical trials evaluating HRQOL. Supplementary material for this article can be found on the HEPATOLOGY website (http://www.interscience.wiley.com/jpages/0270-9139/suppmat/index.html).

Case-Control Studies↗
PubMed2005

Integrating preferences into health status assessment for amyotrophic lateral sclerosis: the ALS Utility Index.

We developed a preference-based measure, the Amyotrophic Lateral Sclerosis Utility Index (ALSUI), allowing computation of US population-based utility weights for the wide range of health states observed among ALS patients. A multi-attribute utility approach was used. An ALS Health State Classification System was developed comprising the following attributes with different severity levels: Speech and Swallowing (A1); Eating, Dressing, and Bathing (A2); Leg Function (A3); and Respiratory Function (A4). An internet-based survey was administered to a random sample of the US population to assess preferences for ALS health states based on this system using visual analog scale (VAS) and standard gamble (SG) questions. Using the VAS and SG data from 1374 individuals in the general population, utility functions were computed that corresponded to each severity level within A1, A2, A3, and A4. ALSUI scores for a given patient are computed by inputting his corresponding utility functions into the following multiplicative formula: ALSUI score = 1.06 x (A1 x A2 x A3 x A4) - 0.06 on a scale where 0.0 reflects death and 1.0 reflects healthy. This study provides a useful tool for classifying ALS patients and determining a general public-based utility score for ALS health states.

Activities of Daily Living↗
PubMed2005

Application of structural equation modeling to health outcomes research.

This article provides an overview of the basic underlying principles of structural equation modeling (SEM). SEM models have two basic elements: a measurement model and a structural model. The measurement model describes the associations between the indicators (observed measures) of the latent variables, whereas the structural model delineates the direct and indirect substantive effects among latent variables and between measured and latent variables. The application of SEM to health outcomes research is illustrated using two examples: (a) assessing the equivalence of the SF-36 and patient evaluations of care for English- and Spanish-language respondents and (b) evaluating a theoretical model of health in myocardial infarction patients. The results of SEM studies can contribute to better understanding of the validity of health outcome measures and of relationships between physiologic, clinical, and health outcome variables.

Cross-Cultural Comparison↗
PubMed2003

Suicide risk in bipolar disorder during treatment with lithium and divalproex.

CONTEXT: Several studies have suggested that lithium treatment reduces risk of suicide in bipolar disorder, but no research has examined suicide risk during treatment with divalproex, the most commonly prescribed mood-stabilizing drug in the United States. OBJECTIVE: To compare risk of suicide attempt and suicide death during treatment with lithium with that during treatment with divalproex. DESIGN AND SETTING: Retrospective cohort study conducted at 2 large integrated health plans in California and Washington. PATIENTS: Population-based sample of 20 638 health plan members aged 14 years or older who had at least 1 outpatient diagnosis of bipolar disorder and at least 1 filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period. MAIN OUTCOME MEASURES: Suicide attempt, recorded as a hospital discharge diagnosis or an emergency department diagnosis; suicide death, recorded on death certificate. RESULTS: In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium for emergency department suicide attempt (31.3 vs 10.8 per 1000 person-years; P<.001), suicide attempt resulting in hospitalization (10.5 vs 4.2 per 1000 person-years; P<.001), and suicide death (1.7 vs 0.7 per 1000 person-years; P =.04). After adjustment for age, sex, health plan, year of diagnosis, comorbid medical and psychiatric conditions, and concomitant use of other psychotropic drugs, risk of suicide death was 2.7 times higher (95% confidence interval [CI], 1.1-6.3; P =.03) during treatment with divalproex than during treatment with lithium. Corresponding hazard ratios for nonfatal attempts were 1.7 (95% CI, 1.2-2.3; P =.002) for attempts resulting in hospitalization and 1.8 (95% CI, 1.4-2.2; P<.001) for attempts diagnosed in the emergency department. CONCLUSION: Among patients treated for bipolar disorder, risk of suicide attempt and suicide death is lower during treatment with lithium than during treatment with divalproex.

Adolescent↗
PubMed2003

Costs of bipolar disorder.

Bipolar disorder is a chronic affective disorder that causes significant economic burden to patients, families and society. It has a lifetime prevalence of approximately 1.3%. Bipolar disorder is characterised by recurrent mania or hypomania and depressive episodes that cause impairments in functioning and health-related quality of life. Patients require acute and maintenance therapy delivered via inpatient and outpatient treatment. Patients with bipolar disorder often have contact with the social welfare and legal systems; bipolar disorder impairs occupational functioning and may lead to premature mortality through suicide. This review examines the symptomatology of bipolar disorder and identifies those features that make it difficult and costly to treat. Methods for assessing direct and indirect costs are reviewed. We report on comprehensive cost studies as well as administrative claims data and program evaluations. The majority of data is drawn from studies conducted in the US; however, we discuss European studies when appropriate. Only two comprehensive cost-of-illness studies on bipolar disorder, one prevalence-based and one incidence-based, have been reported. There are, however, several comprehensive cost-of-illness studies measuring economic burden of affective disorders including bipolar disorder. Estimates of total costs of affective disorders in the US range from $US30.4-43.7 billion (1990 values). In the prevalence-based cost-of-illness study on bipolar disorder, total annual costs were estimated at $US45.2 billion (1991 values). In the incidence-based study, lifetime costs were estimated at $US24 billion. Although there have been recent advances in pharmacotherapy and outpatient therapy, hospitalisation still accounts for a substantial portion of the direct costs. A variety of outpatient services are increasingly important for the care of patients with bipolar disorder and costs in this area continue to grow. Indirect costs due to morbidity and premature mortality comprise a large portion of the cost of illness. Lost workdays or inability to work due to the disease cause high morbidity costs. Intangible costs such as family burden and impaired health-related quality of life are common, although it has proved difficult to attach monetary values to these costs.

Adolescent↗
PubMed2002

An assessment of the independent effects of olanzapine and risperidone exposure on the risk of hyperlipidemia in schizophrenic patients.

BACKGROUND: The newer antipsychotic agents exhibit a superior safety profile compared with conventional antipsychotic agents in terms of extrapyramidal symptoms. Previous studies have suggested an association between olanzapine treatment and hyperlipidemia. We evaluated this association using a large health care database. METHODS: The study was derived from the England and Wales-based General Practice Research Database, composed of 3.5 million subjects followed up between June 1, 1987, and September 24, 2000. A total of 18 309 individuals diagnosed as having schizophrenia were identified. A 6:1 matched nested case-control design was used. Conditional logistic regression was used to derive adjusted odds ratios (ORs), controlling for sex, age, and other medications and disease conditions influencing lipid levels. Antipsychotic drug exposure was defined as the receipt of at least 1 prescription for an antipsychotic medication within the 3 months before the date of diagnosis of hyperlipidemia. RESULTS: There were 1268 incident cases of hyperlipidemia in the cohort, matched to 7598 control subjects. Olanzapine use was associated with nearly a 5-fold increase in the odds of developing hyperlipidemia compared with no antipsychotic exposure (OR, 4.65; 95% confidence interval [CI], 2.44-8.85) (P<.001) and more than a 3-fold increase compared with those receiving conventional agents (OR, 3.36; 95% CI, 1.77-6.39) (P<.001). Risperidone was not associated with increased odds of hyperlipidemia compared with no antipsychotic exposure (OR, 1.12; 95% CI, 0.60-2.11) (P =.72) or conventional antipsychotic exposure (OR, 0.81; 95% CI, 0.44-1.52) (P =.52). CONCLUSIONS: We observed a strong association between olanzapine exposure and hyperlipidemia in schizophrenic patients. The possible metabolic consequences of olanzapine use should be given serious consideration by treating physicians.

Adult↗
PubMed2002

Atopic dermatitis is associated with a decrement in health-related quality of life.

BACKGROUND: Although atopic dermatitis is a chronic skin disease that can have a major impact on a patient's life, the burden of illness associated with this condition has not been well characterized. OBJECTIVE: To determine the health-related quality of life (HRQL) of patients with atopic dermatitis by disease severity and to compare it with that of the general public and of patients suffering from other chronic illnesses or skin disorders. METHODS: Two hundred and thirty-nine atopic dermatitis patients aged 4-70 years completed the Medical Outcomes Study Short Form-36 Health Survey (SF-36) and the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index. These HRQL scores were compared by self-reported patient disease severity ratings. Health-related quality of life scores were compared with those of the general population and those of patients with other chronic conditions (clinical depression, hypertension, type 2 diabetes) or skin disease (psoriasis). Dermatology Life Quality Index scores were also compared with those of other skin diseases (such as psoriasis, Darier's disease, and Hailey-Hailey disease). RESULTS: Patients with atopic dermatitis had inferior scores on the SF-36 vitality, social functioning, and mental health subscales compared with individuals in the general population. In seven of eight subscales, individuals reporting more severe disease had inferior DLQI and SF-36 scores. Patients with atopic dermatitis had inferior mental health scores compared with those with diabetes or hypertension, and inferior social functioning scores compared with patients with hypertension. When compared with a psoriasis cohort, patients with atopic dermatitis had inferior scores in the role-physical, vitality, social functioning, role-emotional, and mental health SF-36 domains. Patients with atopic dermatitis had similar DLQI scores to patients with other chronic dermatologic diseases. CONCLUSIONS: These results demonstrate that atopic dermatitis has an impact on HRQL, particularly in social functioning and psychological wellbeing. Patient-assessed severity of atopic dermatitis correlates with HRQL decrements, indicating greater HRQL impact with greater disease severity. Atopic dermatitis has as large an impact on HRQL as several chronic conditions and other dermatologic conditions.

Adolescent↗
PubMedDate not supplied

Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001.

BACKGROUND: The extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group. METHODS: Working with a member of the US Food and Drug Administration (FDA), four key issues requiring clarification were identified: how PROs are defined and put into operation for research purposes; the added value of PROs in the drug review and evaluation process; selected questions related to the PRO measurement and research methodology; and the interest and demand for PRO information by decision makers. On February 15, 2001, all members of the PRO Harmonization Group attended a meeting in Rockville, Maryland, to discuss these four issues further, and on February 16, 2001, a formal presentation was made to representatives from various departments and reviewing divisions of the FDA. These presentations are summarized in this report. RESULTS: All participants agreed that PROs are important for understanding the impact of treatment on patient functioning and well-being. They also stressed the need to communicate PRO information to key decision makers, including regulatory agencies, clinicians, patients and their families, and payers. Finally, the meeting resulted in plans for continuing the dialogue on PRO measurement and interpretation. SUMMARY: The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.

Advisory Committees↗
PubMedDate not supplied

Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003.

OBJECTIVES: The objective of this study was to review and analyze the use of health-related quality of life (HRQL) and other patient-reported outcome (PRO) evaluations for the approval of new pharmaceutical products by the European Medicines Agency (EMEA). METHODS: All published EMEA guidance documents and regulatory information for products authorized at the EMEA and appearing in the European Public Assessment Report (EPAR) database between 1995 and 2003 were examined for reference to HRQL and other PROs. RESULTS: More than half of the guidance documents for clinical investigation of pharmaceutical products in specific disease areas included reference to HRQL or other PROs. Guidance notes for 10 conditions indicated PROs can serve as primary endpoints in clinical trials, among which three included HRQL outcomes. The review of EPAR documentation uncovered HRQL and other PRO data for 34% of the drugs registered during the period of the review, with cancer-related treatments most frequently including PRO data. There was a trend toward increasing HRQL and other PRO claims in regulatory documents of pharmaceutical products in recent years, with the proportion exceeding 30% from 1999 to 2003. CONCLUSIONS: There is further scope for health outcomes researchers and regulatory decision-makers to contribute to the more efficient utilization of PROs and HRQL outcomes. Health researchers need to better justify the inclusion of these outcomes in clinical trials and highlight the added value of PRO data; while the regulators should develop harmonized procedures and capacities to adequately appraise the submitted information.

Chronic Disease↗
PubMedDate not supplied

Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication.

PURPOSE: The 20-item Subcutaneous Injection Survey (SIS) was developed to assess patients' experience with subcutaneous self-injection of an innovative anti-HIV fusion inhibitor (T-20). It measures ease of use and impact of treatment on daily life. This study presents the results of a psychometric evaluation of the SIS. METHOD: The SIS and MOS-HIV data (N = 547) from two multinational, phase III clinical trials of optimized background therapy (OBT) vs. OBT + T-20 were utilized for this evaluation. Item performance and internal consistency reliability were assessed. Exploratory factor analysis was used to identify subscales. Pearson correlations were used to examine the relationship between the SIS and the MOS-HIV scores. RESULTS: Patients were predominately white males. SIS items had low rates of missing data (0.9%-5.5%) and with two exceptions were not redundant, as indicated by generally moderate item-to-item correlations. Three factors were identified: daily functioning, ease of injections, and activities of daily living. The SIS also includes three individually scored items on overall injection interference with daily activities, effect of injections on daily activities, and satisfaction with personal appearance. Cronbach's alphas ranged from 0.71 to 0.87. Correlations between SIS and MOS-HIV subscales were low to moderate. CONCLUSION: The SIS is a reliable instrument for measuring patients' assessment of self-injection in HIV clinical trials. Patients' experiences with self-injection are not strongly associated with health-related quality of life.

Adult↗