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Biomedical subjects

Dennis A Revicki

Publications and source records attributed to Dennis A Revicki.

14 recordsLinked to original sources
PubMed2003

Treating depression in predominantly low-income young minority women: a randomized controlled trial.

CONTEXT: Impoverished minority women experience a higher burden from depression than do white women because they are less likely to receive appropriate care. Little is known about the effectiveness of guideline-based care for depression with impoverished minority women, most of whom do not seek care. OBJECTIVE: To determine the impact of an intervention to deliver guideline-based care for depression compared with referral to community care with low-income and minority women. DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled trial conducted in the Washington, DC, suburban area from March 1997 through May 2002 of 267 women with current major depression, who attended county-run Women, Infants, and Children food subsidy programs and Title X family planning clinics. Outcomes Hamilton Depression Rating Scale measured monthly from baseline through 6 months; instrumental role functioning (Social Adjustment Scale) and social functioning (Short Form 36-Item Health Survey) measured at baseline and 3 and 6 months. INTERVENTIONS: Participants were randomly assigned to an antidepressant medication intervention (trial of paroxetine switched to buproprion, if lack of response) (n = 88), a psychotherapy intervention (8 weeks of manual-guided cognitive behavior therapy) (n = 90), or referral to community mental health services (n = 89). RESULTS: Both the medication intervention (P<.001) and the psychotherapy intervention (P =.006) reduced depressive symptoms more than the community referral did. The medication intervention also resulted in improved instrumental role (P =.006) and social (P =.001) functioning. The psychotherapy intervention resulted in improved social functioning (P =.02). Women randomly assigned to receive medications were twice as likely (odds ratio, 2.04; 95% confidence interval, 0.98-4.27; P =.057) to achieve a Hamilton Depression Rating Scale score of 7 or less by month 6 as were those referred to community care. CONCLUSIONS: Guideline-concordant care for major depression is effective for these ethnically diverse and impoverished patients. More women engaged in a sufficient duration of treatment with medications compared with psychotherapy, and outcome gains were more extensive and robust for medications.

Adult↗
PubMed2003

Health-related quality-of-life outcomes of sirolimus-treated kidney transplant patients after elimination of cyclosporine A: results of a 2-year randomized clinical trial.

BACKGROUND: This study compared 2-year health-related quality-of-life (HRQL) outcomes of sirolimus (SRL)-treated kidney transplant patients after elimination of cyclosporine A (CsA) to patients continuing on a combined CsA and SRL regimen. METHODS: A randomized, open-label, clinical trial was performed in Europe, Australia, and Canada. Four hundred thirty kidney transplant patients were randomly assigned to sirolimus plus steroids (ST) (n=215) or SRL and CsA+ST (n=215) therapy after 3 months of combined SRL+CsA+ST treatment. HRQL was measured using the Kidney Transplant Questionnaire (KTQ) and the SF-36 Health Survey at month 3 (time of randomization) and months 12 and 24 after transplantation. Repeated-measures analysis of covariance was used to evaluate treatment differences in HRQL scores over the 2-year period. RESULTS: HRQL scores were available for 361 (86%) eligible study patients. Statistically significant treatment-by-assessment time interactions, favoring SRL+ST, were found on KTQ Fatigue (P=0.0158) and Appearance scores (P=0.0007). No treatment differences were observed in KTQ Physical Symptom, Uncertainty-Fear, and Emotion scores. Statistically significant treatment-by-assessment time interactions were observed for SF-36 Vitality scores (P=0.0203) but not other SF-36 scores (P>0.05). For Vitality scores, the SRL+ST group remained stable (mean, 0.4-point change) from month 3 to month 24 compared with decreases in the SRL+CsA+ST group (mean, -6.5-point change). CONCLUSIONS: SRL-based therapy with early elimination of CsA results in fewer appearance-related problems, less fatigue, and better vitality compared with continuous treatment with SRL, CsA, and ST.

Adult↗
PubMed2003

Depression with atypical features in the National Comorbidity Survey: classification, description, and consequences.

BACKGROUND: Atypical depression has been found to be distinct from other types of depression in terms of psychiatric symptom profile and treatment response. However, debate continues regarding its specific characteristics, impact, and diagnostic criteria. The current study was conducted to increase understanding of atypical depression diagnosed using only the reversed vegetative symptoms of hypersomnia and hyperphagia. METHODS: An atypical depression group (n = 304 [36.4% of the depressed sample; 39.0% when weighted to approximate the national population]) was identified within the US National Comorbidity Survey, which assessed psychiatric disorders among a nationally representative sample using the Composite International Diagnostic Interview. The atypical group was identified based on DSM-III-R criteria for a major depressive episode, in addition to atypical features of hypersomnia and hyperphagia. Comparison groups were those with nonatypical depression (n = 532) and individuals without a psychiatric disorder (n = 4071). RESULTS: Compared with nonatypical depression, atypical depression was associated with a greater percentage of women and an earlier age of onset. The atypical group also reported higher rates of most depressive symptoms, suicidal thoughts and attempts, psychiatric comorbidity (panic disorder, social phobia, and drug dependence), disability and restricted activity days, use of some health care services, paternal depression, and childhood neglect and sexual abuse (P<.05). Compared with people without psychiatric disorders, the atypical group reported higher rates of disability and restricted activity days, use of all mental health care services, parental depression, and childhood abuse (P<.001). CONCLUSIONS: This analysis of a nationally representative US sample suggests that overeating and oversleeping can be used to identify an atypical depression subgroup that is distinct from other depressed patients in terms of demographics, psychiatric comorbidities, and abuse history. Findings also suggest that atypical depression is associated with increased distress, suicidal ideation, and disability compared with nonatypical depression.

Activities of Daily Living↗
PubMed2003

Evaluating effects of method of administration on Walking Impairment Questionnaire.

BACKGROUND: Intermittent claudication resulting from peripheral arterial disease (PAD) can substantially impair walking function. The Walking Impairment Questionnaire (WIQ) assesses patient self-reported difficulty in walking. Currently this questionnaire is validated for interviewer administration only. Since this can be burdensome in a large clinical trial, we examined the effects of alternative methods of administration on patient responses on the WIQ. METHODS: The WIQ, which consists of four subscales (pain severity, distance, speed, stairs), was modified to be self-administered or interviewer-administered by telephone. Patients with PAD were recruited from two sites and randomized into two groups: in group 1 the WIQ was self-administered, then telephone-administered; in group 2 the WIQ was telephone-administered, then self-administered. The two administrations occurred 4 to 7 days apart. Additional measures (SF-36, EQ-5D, and PAD symptom scale) and clinical data were included to further assess the validity of the WIQ and symptoms in patients with claudication. Telephone interviews were conducted by trained interviewers using standardized scripts. Two-week test-retest reliability was assessed for both the self-administered WIQ (group 1) and the telephone-administered WIQ (group 2). RESULTS: Sixty patients were recruited at two sites (n = 30 per group). Seventy-eight percent were men; mean patient age was 67.1 years; and 83% of patients were white. Mean duration of PAD symptoms was 6.8 years. No significant differences were observed in WIQ subscale scores between self administration and telephone administration. No interaction effects between order and method of administration were detected. Cronbach alpha for distance, speed, and stair-climbing subscales ranged from 0.82 to 0.94. Correlations among WIQ subscales and the symptom scale were good (r = -0.34 to -0.57). Correlations of WIQ subscales with physical health subscales of the SF-36 (r = 0.24-0.59) were higher than for mental health-related subscales (r = 0.08-0.26). CONCLUSIONS: The modified WIQ demonstrated good reliability and validity with both methods of administration. These results suggest that the self-administered and telephone-administered versions of the WIQ can be used reliably and efficiently in clinical trials.

Aged↗
PubMed2003

Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.

BACKGROUND: Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a. OBJECTIVES: To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon]. DESIGN: A randomised, international, multicentre, open-label, parallel group study. SETTING: 36 centres worldwide. PATIENTS: Interferon-naïve patients (n = 531) with chronic hepatitis C. INTERVENTIONS: Peginterferon alpha-2a (40kD) 180 mirog once a week (n = 267) for 48 weeks or unmodified interferon alpha-2a 6 million IU three times a week for 12 weeks followed by 36 weeks of 3 million IU three times a week (n = 264). MEASUREMENTS: Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36). RESULTS: At weeks 2 and 12, differences favouring peginterferon alpha-2a (40kD) were seen on seven of eight domains and both summary scores of the SF-36 (p < 0.05 to p < 0.01). At weeks 2, 12 and 24, patients receiving peginterferon alpha-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon alpha-2a. CONCLUSION: Treatment with peginterferon alpha-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon alpha-2a. In addition to safety and efficacy, the impact on health-related quality of life may be an important consideration for physicians when selecting an optimal treatment regimen.

Adult↗
PubMed2003

The impact of treatment for gastro-oesophageal reflux disease on health-related quality of life: a literature review.

Gastro-oesophageal reflux disease (GORD) is common in the general population and is diagnosed based on patient-reported symptoms and clinical tests. Although clinical tests are available, significant percentages of patients report symptoms of heartburn and reflux despite negative endoscopies, and 24-hour pH tests are not often used by primary-care physicians in diagnosis. Consequently, patient-reported symptoms and health-related QOL (HR-QOL) are important in assessing treatment outcome. HR-QOL is significantly impaired in patients with GORD, and HR-QOL is associated with symptom severity and changes in GORD-related symptoms. The objective of this literature review is to examine the impact of pharmacological treatment on HR-QOL in patients with GORD. Generic and disease-specific HR-QOL measures have been used in clinical trials to evaluate the impact of GORD on patient functioning and well-being. The Psychological General Well-Being (PGWB) Index and the 36-Item Short-Form Health Survey (SF-36) have been used in several clinical trials of treatment for GORD and have consistently shown that HR-QOL improves with successful therapy. These trials have been conducted primarily with two pharmacological agents, omeprazole and ranitidine. On the Heartburn-specific Quality of Life questionnaire, patients treated with ranitidine reported better HR-QOL after treatment compared with placebo therapy. In two clinical trials where omeprazole and ranitidine were compared, patients treated with omeprazole reported significantly better HR-QOL (based on the PGWB Index) than those treated with ranitidine; however, 2 other trials did not detect significant differences between the treatments. Results from clinical trials using disease-specific measures (Gastrointestinal Quality of Life Index [GIQLI] and Heartburn-specific Quality of Life questionnaire) demonstrate similar findings, supporting the association between treatment-related symptom resolution and improvements in HR-QOL. The GIQLI was used in a trial comparing pantoprazole and ranitidine, where results favoured pantoprazole therapy. Several studies have demonstrated that resolution of GORD symptoms is associated with improvement in HR-QOL. Although there is evidence that treatment for GORD does improve symptoms and HR-QOL outcomes, further research is needed to more completely understand the value of medical therapy for GORD.

Drug Evaluation↗
PubMed2003

Divalproex sodium versus olanzapine in the treatment of acute mania in bipolar disorder: health-related quality of life and medical cost outcomes.

BACKGROUND: Divalproex sodium is a mood stabilizer used in the United States for the treatment of acute mania associated with bipolar disorder. Recently, olanzapine, an atypical antipsychotic, was approved for the treatment of acute mania. This study compares the clinical, health-related quality of life (HRQL), and economic outcomes of divalproex and olanzapine in the treatment of acute mania associated with bipolar disorder. METHOD: This 12-week, double-blind, double-dummy, randomized clinical trial included 120 subjects with DSM-IV bipolar disorder type I hospitalized for an acute manic episode recruited from 21 U.S. clinical centers. Subjects were randomly assigned to treatment with either divalproex or olanzapine and were followed in hospital for up to 21 days. If after 21 days clinical improvements (based on the Mania Rating Scale [MRS]) were not observed, subjects were discontinued. Subjects showing clinical improvement were treated for up to 12 weeks. HRQL was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) after hospital discharge (baseline) and at 6 and 12 weeks. Medical resource use and costs were collected over the 12-week study. RESULTS: A total of 120 subjects (N = 63 divalproex, N = 57 olanzapine) were randomized, and 78 (65%) were followed beyond 21 days. No statistically significant differences between the treatment groups for baseline-to-endpoint MRS or Q-LES-Q scores were observed. Total 12-week outpatient medical costs were significantly lower for the divalproex-treated group (541 US dollars) compared with the olanzapine-treated group (1080 US dollars) (p =.004). There was no significant difference in total medical costs between the 2 groups (divalproex = 13,703 US dollars; olanzapine = 15,180 US dollars; p =.88). CONCLUSION: Divalproex is associated with lower 12-week outpatient costs compared with olanzapine. Divalproex and olanzapine have similar short-term effects on clinical or HRQL outcomes in bipolar disorder subjects.

Acute Disease↗
PubMed2002

Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case-control study.

OBJECTIVE: To quantify the association between olanzapine and diabetes. DESIGN: Population based nested case-control study. SETTING: United Kingdom based General Practice Research Database comprising 3.5 million patients followed between 1987 and 2000. PARTICIPANTS: 19 637 patients who had been diagnosed as having and treated for schizophrenia. 451 incident cases of diabetes were matched with 2696 controls. MAIN OUTCOME MEASURES: Diagnosis and treatment of diabetes. RESULTS: Patients taking olanzapine had a significantly increased risk of developing diabetes than non-users of antipsychotics (odds ratio 5.8, 95% confidence interval 2.0 to 16.7) and those taking conventional antipsychotics (4.2, 1.5 to 12.2). Patients taking risperidone had a non-significant increased risk of developing diabetes than non-users of antipsychotics (2.2, 0.9 to 5.2) and those taking conventional antipsychotics (1.6, 0.7 to 3.8). CONCLUSION: Olanzapine is associated with a clinically important and significant increased risk of diabetes.

Adult↗
PubMed2002

Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients.

Interferon therapy may exacerbate health-related quality of life (HRQL) deficits associated with hepatitis C virus (HCV) early in the course of therapy. Treatment with polyethylene glycol-modified interferon (peginterferon) alfa-2a (40 kd) provides improved sustained response over interferon alfa-2a, but its effect on HRQL is unknown. The objective of this study was to (1) evaluate the effect of sustained virologic response on HRQL in patients with HCV and (2) determine whether impairment of HRQL during treatment contributes to early treatment discontinuation. Data consisted of a pooled secondary analysis of patients (n = 1,441) across 3 international, multicenter, open-label, randomized studies that compared peginterferon alfa-2a (40 kd) with interferon alfa-2a. ANCOVA was used to examine the effect of sustained virologic response on HRQL. Repeated-measures mixed-models ANCOVA was used to compare Fatigue Severity Scale (FSS) and SF-36 scores during treatment by treatment group. Logistic regression analysis was used to examine the association between changes at baseline in on-treatment HRQL and early treatment discontinuation. Sustained virologic response was associated with marked improvements from baseline to end of follow-up in all subjects, including patients with cirrhosis. During treatment, patients receiving peginterferon alfa-2a (40 kd) had statistically significantly better scores on both the SF-36 and FSS. Baseline to 24-week changes in fatigue and SF-36 mental and physical summary scores significantly predicted treatment discontinuation. In conclusion, sustained virologic response is associated with improvements in quality of life in patients with or without advanced liver disease. This parameter may be an important consideration in maximizing treatment adherence.

Adult↗
PubMed2002

Vision-specific instruments for the assessment of health-related quality of life and visual functioning: a literature review.

Clinically objective measures such as visual acuity or visual field provide an assessment of a patient's visual status. However such measures may not reflect the degree of visual impairment the patient experiences in his or her daily activities. Visual impairment has been shown to have negative effects on health-related quality of life (HR-QOL) and a significant impact on daily functioning, including social activities. As such, there is a growing recognition of the importance of patient-reported outcomes of visual functioning. This review examines the development and psychometric properties of 22 vision-specific instruments assessing visual functioning and/or the impact of visual impairment on HR-QOL or daily activities. Issues relevant to assessing vision-specific subjective outcomes are reviewed, with specific application of the reviewed instruments. Three instruments, the Activities of Daily Vision Scale, National Eye Institute Visual Function Questionnaire, and Visual Function Index have been well validated and widely used, but others also show promise. To fully capture the benefits of a new ophthalmology treatment (or new treatment for eye disease) a valid and reliable visual instrument, in which the psychometric performance has been demonstrated in the particular ocular condition being treated, should be utilised.

Humans↗
PubMed2002

Assessing meaningful change in quality of life over time: a users' guide for clinicians.

The objective of this article is to help clinicians interpret trial-based quality of life (QOL) changes over time. We address a series of questions and provide guidelines that are fundamental to assessing and interpreting change. The issues addressed are as follows: (1) What are the characteristics of the population for whom changes in QOL are reported? (2) Is the QOL questionnaire reliable, valid, and responsive to change? (3) Are the timing and frequency of assessments adequate? (4) Is the study adequately powered? (5) How are multiple QOL outcomes addressed in analyses? (6) How are multiple time points handled? (7) Can alternative explanations account for the observed change or lack of observed change (eg, handling of missing data, survival differences, and changes in patient's QOL perspective over time)? and (8) How is statistical significance translated into meaningful change? These guidelines will support clinicians in reviewing the clinical trial literature, which in turn can help them use the data in the treatment decision process.

Adenocarcinoma↗
PubMedDate not supplied

A cost-effectiveness clinical decision analysis model for treatment of Schizophrenia.

BACKGROUND: Schizophrenia afflicts approximately 0.7% of Mexican citizens during their lifetime. This study explored whether the difference in clinical efficacy and safety between atypical antipsychotics and conventional neuroleptics results in decreases in use and cost of medical services in Mexico, offsetting the higher price of atypical antipsychotics. METHODS: A U.S. decision analytic Markov model was adapted for use in Mexico to determine cost-effectiveness of treatments and outcomes that Mexican patients with schizophrenia may experience over a 5-year period when treated with olanzapine, haloperidol, or risperidone. Model parameter estimates were based on clinical trial data, published medical literature, and where needed, clinician judgment. Direct medical costs were incorporated into the model and outcomes were estimated using lack of relapse and clinical outcomes based on the Brief Psychiatric Rating Scale (BPRS) as effectiveness indicators. All costs are reported in Mexican pesos. RESULTS: Over a 5-year period, the cost of treating schizophrenia ranged from 196,620 pesos per patient initiating therapy with haloperidol to 226,670 pesos per patient beginning therapy with risperidone. Olanzapine was estimated to have slightly better non-relapse and BPRS-based effectiveness outcomes, but comparative total medical costs compared to risperidone. Patients receiving olanzapine experienced 13 and 2% fewer relapses compared with patients on haloperidol and risperidone, respectively. The 5-year incremental cost-effectiveness ratio of olanzapine compared with haloperidol was 52,740 pesos per improved patient, BPRS-based outcome and 212,540 pesos per avoided relapse. Sensitivity analyses indicated the model was sensitive only to changes in drug costs. CONCLUSIONS: Compared with haloperidol, olanzapine therapy results in improved symptoms, fewer relapses, and is cost-effective, even with conservative values for key model parameters. Olanzapine results in slightly improved patient outcomes and comparable costs compared with risperidone.

Ambulatory Care↗
PubMedDate not supplied

Incorporating quality of life measures in HIV clinical trials.

PURPOSE: To increase awareness regarding issues specific to health-related quality of life (HRQL) assessments for investigators designing clinical trials and for clinicians reading published reports on clinical trials. HQRL measures are becoming more prevalent, alongside conventional therapeutic and laboratory endpoints. However, they differ from these physiologic or biologic measurements because HRQL data are subjective. We discuss the criteria for selecting and implementing HRQL instruments to optimize the usefulness of HRQL assessments in clinical studies. METHOD: We conducted a review of selected design and measurement issues that should be considered when planning for the use of HRQL instruments in HIV/AIDS clinical trials. CONCLUSION: When used appropriately, HRQL measures can indicate the impact of HIV treatment on patient functioning and well-being and can help to inform clinicians about treatment effects.

Clinical Trials as Topic↗