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Biomedical subjects

T R Hylan

Publications and source records attributed to T R Hylan.

At least 19 recordsLinked to original sources

Antidepressant use in clinical practice: efficacy v. effectiveness.

BACKGROUND: Although the efficacy of antidepressants has been demonstrated in randomised, controlled clinical trials, it is how an antidepressant is used in clinical practice that determines its clinical effectiveness, or real-world efficacy. AIMS: To explore the frequency with which antidepressants are used at adequate dose and duration to obtain remission of symptoms and prevent relapse in clinical practice and discuss potential implications for clinical outcomes. METHOD: Studies of antidepressant prescribing were reviewed and comparisons made between antidepressant classes and individual compounds within those classes. RESULTS: Naturalistic studies show that patients who begin therapy on tricyclic antidepressants often receive sub-therapeutic doses for inadequate duration; conversely, patients who begin therapy on selective serotonin reuptake inhibitors more often receive an adequate dose of therapy for a longer duration. CONCLUSIONS; How antidepressants are used in clinical practice can determine the clinical outcomes that are achieved. Antidepressants that are more forgiving of sub-optimal prescribing and use patterns by providers and patients, respectively, may help to improve real-world efficacy.

Antidepressive Agents↗

Initial treatment choice in depression: impact on medical expenditures.

OBJECTIVE: The purpose of this study was to examine the economic outcomes associated with initial treatment choice following a diagnosis of depression. METHODS: Insurance claims data were used to classify patients into one of 4 treatment cohorts: no therapy, psychotherapy, drug therapy and combination therapy. Potential sample selection bias was accounted for by using a 2-stage econometric estimation procedure where initial treatment choice was estimated using a multinomial logistic regression model in the first stage, and total and mental healthcare costs were estimated in ordinary least squares regression models in the second stage. Log predicted costs from the second stage were compared to determine the relative costs associated with each cohort. RESULTS: Significant differences (p < 0.008) in total costs were found between the combination therapy (log predicted cost = 9.526) and psychotherapy cohorts (log predicted cost = 8.120) in the analysis that included all observations (n = 9110). In the analysis that included patients who initiated therapy with a non-mental health provider (n = 2673), the drug therapy cohort (log predicted cost = 8.238) was found to be significantly more costly as compared to the no therapy cohort (log predicted cost = 7.788). CONCLUSIONS: These results indicate that after controlling for both observed and unobserved factors, total healthcare costs may be higher in patients who initiate therapy with drug therapy and combination therapy as opposed to no therapy or psychotherapy. In addition, the finding that patients initially receiving psychotherapy alone tend to have higher mental healthcare costs but lower total healthcare costs than other patients may indicate that psychotherapy has an impact on comorbid illness and may subsequently reduce total healthcare costs.

Antidepressive Agents↗

The impact of premenstrual symptomatology on functioning and treatment-seeking behavior: experience from the United States, United Kingdom, and France.

Up to 80% of women experience mood and physical symptoms associated with the menstrual cycle. This study assessed the impact of premenstrual symptomatology on functioning and treatment-seeking behavior for a community-based sample of women in the United States, United Kingdom, and France. A sample of 1045 menstruating women (aged 18-49) completed a telephone questionnaire that measured, at a point in time, premenstrual symptoms, impact on functioning, and treatment-seeking behavior. Results were generally consistent across the three countries. Irritability/anger, fatigue, and physical swelling/bloating, or weight gain were among the most commonly reported symptoms (approximately 80%). Functional impairment tended to be highest at home, followed by social, school, and occupational situations. Among working women, over 50% reported at least somewhat affected occupational functioning. Of women who ever missed work because of symptoms, 1-7 days were missed in the past year. Almost three fourths of the women had never sought treatment, and symptom severity was an important factor in treatment-seeking behavior. Treatment with selective serotonin reuptake inhibitors (SSRIs), which have demonstrated efficacy in this population, occurred with surprisingly low frequency. The functional impairment of premenstrual symptomatology (home, social, and occupational) and treatment-seeking behavior is consistent across countries. Women who experience more impairment are more likely to have severe symptoms and are more likely to believe, relative to women with less severe symptoms, that no treatment is available. This suggests significant unmet medical need in this more severely affected population. Improved clinical identification of these women and increasing awareness of the efficacy of SSRIs in treating premenstrual symptomatology may be of benefit.

Adaptation, Physiological↗

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.

Adult↗

A framework for drug utilization evaluation in depression: insights from outcomes research.

BACKGROUND: Drug utilization evaluation (DUE) offers the prospect of improving the quality of care in depression by focusing on drug-related problems (DRPs). Outcomes research in depression can provide a basis on which to address difficulties in implementing DUE programs in the outpatient environment of managed care. OBJECTIVE: The purpose of this paper is to facilitate the development of a drug utilization evaluation program for depressed patients receiving care in an outpatient environment. METHODS: The literature was reviewed in the area of depression treatment, drug-related problems, and current outcomes research. This information was synthesized into a framework with potential DUE criteria. CONCLUSION: The quality of care for depression can be improved if these efforts are focused on solving DRPs. Outcomes research findings may be used as the basis for developing DUE criteria and as a first step in selecting and targeting interventions.

Ambulatory Care↗

Longitudinal patterns of antidepressant prescribing in primary care in the UK: comparison with treatment guidelines.

The objective of this study was to determine whether patients beginning therapy on the most common tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs) differed in their likelihood of having antidepressant treatment that was consistent with recommended treatment guidelines in the UK. An analytical file constructed from a large general practitioner medical records database (DIN-LINK) from the UK for the years 1992-97 was constructed. A total of 16,204 patients with a new episode of antidepressant therapy who initiated therapy on one of the most often prescribed TCAs (amitriptyline, dothiepin, imipramine and lofepramine) or SSRIs (fluoxetine, paroxetine and sertraline) were analysed. A dichotomous measure was defined to indicate whether subjects were prescribed at least 120 days of antidepressant therapy at an adequate average daily dose within the first 6 months after initiation of therapy. Only 6.0% of patients initiating therapy on aTCA and 32.9% of patients initiating therapy on a SSRI were prescribed antidepressant treatment that was consistent with treatment guidelines. After controlling for observable characteristics, patients who initiated therapy on a SSRI were much more likely (odds ratio=7.473, p<0.001) to have a prescribed average daily dose and duration consistent with recommended treatment guidelines within the first 6 months of initiating therapy than were patients who initiated therapy on a TCA. These findings suggest that initial antidepressant selection is an important determinant of whether the subsequent course of treatment is consistent with current national guidelines for the treatment of depression in the UK.

Adult↗

[The costs of treatment with the new antidepressants in clinical practice].

OBJECTIVE: To assess if, in usual clinical practice, the patterns of use of new antidepressant are associated to different health resource utilisation. DESIGN: Naturalistic, retrospective, observational study. SETTING: Urban health center. PATIENTS: DSM-IIIR diagnostic criteria of depressive disorder and treatment with a new antidepressant (n = 328). INTERVENTIONS: Information on resource utilisation was collected in those patients treated with fluoxetine (FLX), fluvoxamine (FLV) sertraline (SER), paroxetine (PAR) and venlafaxine (VLF). Direct, indirect and total costs were compared according to the different patterns of use (stable therapy, upward dose titration, switching or augmentation) and according to the initially prescribed antidepressant. The follow-up period was 6 months. RESULTS: Direct and total daily costs of those patients with unestable therapy (upward dose titration, switching or augmentation) were 55% (p < 0.01) and 87% (p = 0.001) higher than for patients with stable therapy, respectively. Patients who initiated therapy on SER, VLF and PAR had 35% (p < 0.05), 80% (p < 0.05) and 37% (p < 0.05), respectively, higher average total costs per day than patients who initiated therapy with FLX. Regarding direct costs, patients who initiated therapy on SER and VLF had 48% (p < 0.001) and 58% (p < 0.05) higher average costs per day than patients who initiated therapy with FLX. CONCLUSIONS: New antidepressants show different patterns of use in a clinical practice setting, being FLX the agent more associated to a stable pattern of use. The pattern of use is associated to different health resource utilisation. Patients under stable therapy show lower health costs than those who need upward titration, switching or augmentation strategies. It is necessary to conduct randomized naturalistic studies to confirm these results.

Adult↗

Antidepressant use and resource utilization in the general practitioner setting in The Netherlands.

OBJECTIVE: To assess antidepressant use and resource utilization in the general practitioner (GP) setting in the Netherlands following initiation of antidepressant therapy. DESIGN: Longitudinal study in a retrospective database. PARTICIPANTS: Sample of 869 patients from a new database in the Netherlands who initiated therapy on a selective serotonin re-uptake inhibitor (SSRI) or a tricyclic antidepressant (TCA). MAIN OUTCOME MEASURES: Mean length of antidepressant therapy within the first 90 days and resource utilization in the GP setting in the first 180 days following therapy initiation. RESULTS: (1) patients who initiated therapy on an SSRI were younger (48.6 years old versus 54.1 years old, p<0.01) and more likely to have a depression diagnosis (58% versus 30%, p<0.01) than patients who initiated therapy on a TCA; (2) patients who initiated therapy on an SSRI were more likely than patients who initiated therapy on a TCA (65% versus 52%, p<0.01) to have more than 30 days of therapy within the first 90 days and to receive antidepressant doses consistent with Dutch guidelines; (3) patients with greater than 30 days of antidepressant therapy within the first 90 days had more general practitioner visits than patients with 30 days of therapy or less (TCA patients: 9.6 versus 7.0; SSRI patients: 8.8 versus 6.9, p<0.01). CONCLUSIONS: Patients in the GP setting in the Netherlands who initiate therapy on SSRIs are more likely than patients who initiate therapy on TCAs to receive recommended doses and duration of therapy consistent with Dutch antidepressant treatment guidelines.

Journal Article↗

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.

1-Naphthylamine↗

Randomized database studies: a new method to assess drugs' effectiveness?

The need to evaluate drugs' effects in real clinical practice is increasingly important. Randomized clinical trials (RCTs) and database analyses (DBA) are the two main methods to assess treatments effectiveness. RCTs remain the "gold standard" for comparing alternative treatments. However, they are conducted under strict, protocol-driven conditions that may limit their generalizability. Advantages of new high quality clinical databases, on the other hand, include the simple and economic access to large number and range of cases, and the ability to capture all aspects of actual medical practice. The main potential limitation of DBA is the potential for comparison bias due to the lack of randomization. Despite the efforts to design naturalistic trials and to use sophisticated statistical techniques to minimize selection bias, the inherent limitations of both methods (problems of external and internal validity, respectively) have not been completely solved. Thus, the actual challenge is the development of some new strategy capable of generating results with an acceptable balance between internal and external validity. As randomization is essential to minimize comparison bias, we point out the possibility to include randomization modules in computer-based patient records. The theoretical foundation of these "randomized database studies" is the simultaneous use of both experimental and observational methods in the assessment of drugs' effectiveness. The progressive standardization of clinical practice and the development and adoption of improved computer-based patient records could facilitate the use of this new research strategy.

Databases, Factual↗

Gaps in antidepressant prescribing in primary care in the United Kingdom.

An important determinant for achieving efficacy results in clinical practice comparable to those demonstrated in clinical trials is whether or not patients take their medication as prescribed. Recent studies have shown that 30-60% of patients do not take their medications as prescribed. Gaps between antidepressant prescriptions raise questions about the possibility of periods of nonadherence to medication in clinical practice. The purpose of conducting this study was to assess the likelihood of experiencing a gap of > 15 days between antidepressant prescriptions for patients with a depression-related diagnosis and to assess whether this likelihood varied across different antidepressants with tricyclic antidepressants and selective serotonin reuptake inhibitors. Episodes of antidepressant treatment were constructed using the Doctors' Independent Network general practitioner medical records database. For all antidepressant agents considered, approximately 50% of patients had a gap between prescriptions and 15-25% of patients had a gap of > 15 days between prescriptions. A significant proportion of patients in a general practitioner setting in the UK have gaps recorded of > 15 days between antidepressant prescriptions. Gaps between prescriptions raise the question of whether patients may be at risk for clinical consequences associated with nonadherence to therapy, such as reduced effectiveness or treatment interruption symptomatology.

Antidepressive Agents↗

Predictors of a medical-offset effect among patients receiving antidepressant therapy.

OBJECTIVE: Characteristics of patients receiving antidepressant therapy were examined to identify factors that may be associated with a medical-offset effect. METHOD: In a retrospective study, the authors analyzed claims data from a large health insurer in New England. The study subjects included 1,661 persons initiating treatment for depression with selective serotonin reuptake inhibitors or tricyclic antidepressants between July 1991 and June 1993. RESULTS: Patients with anxiety disorders, coronary heart disease, cancer, and chronic fatigue syndrome and those remaining on their initial regimens of antidepressant therapy for at least 6 months were more likely to experience significant reductions in the costs of medical care services. The number of visits to mental health providers had no effect on the costs of medical services. CONCLUSIONS: Specific comorbid conditions and sustained use of antidepressant drugs may be associated with a medical-offset effect for patients receiving treatment for depression.

Adult↗

Antidepressant selection and use and healthcare expenditures. An empirical approach.

The purpose of this study was to evaluate whether 1-year total healthcare expenditures differed between patients who initiated therapy on a tricyclic antidepressant (TCA) or a selective serotonin reuptake inhibitor (SSRI) after controlling for initial antidepressant selection and antidepressant use pattern. A retrospective claims database covering a privately insured population in the US was used. Patients who initiated therapy in the outpatient setting (primary care or psychiatrist) were considered. Two-stage sample selection models were estimated that included controls for initial antidepressant selection and use pattern. The analyses indicated that: (i) self-selection due to initial antidepressant selection was a statistically significant determinant of expenditures for patients who initiated therapy on a TCA but not an SSRI; (ii) after controlling for initial antidepressant selection, antidepressant use pattern was a statistically significant and positive determinant of expenditures for both TCA and SSRI patients; and (iii) after controlling for initial antidepressant selection and use pattern, 1-year total direct healthcare expenditures were significantly lower for patients who initiated therapy on an SSRI than for patients who initiated therapy on a TCA.

Antidepressive Agents↗

Outpatient antidepressant utilization in a Dutch sick fund.

OBJECTIVE: To identify quality improvement opportunities in the management of depression by evaluating patterns of antidepressant use and concurrent use of anxiolytics or sedative/hypnotics among patients who initiated therapy with amitriptyline, fluoxetine, fluvoxamine, or paroxetine. DESIGN: A longitudinal, retrospective study using electronic prescription data from a Dutch sick fund, ZAO Zorgverzekeringen. PATIENTS AND METHODS: The study patients (n = 2,554) initiated therapy between October 1, 1994 and December 31, 1995. Follow-up periods were 6 months (antidepressant use) and 60 days (concurrent anxiolytic and sedative/hypnotic use). RESULTS: The three key findings were as follows: (1) the majority of patients received less than 4 months of therapy (more common for patients receiving amitriptyline); (2) the average daily doses for initial prescriptions for all four study drugs were below the recommended therapeutic minimums for depression (overall and final amitriptyline doses also were consistently low); and (3) the incidence of concurrent anxiolytic and sedative/hypnotic use during days 2-60 after antidepressant therapy initiation was 18.2%. CONCLUSION: The study suggests that patients in this Dutch sick fund were not likely to receive either adequate antidepressant doses or adequate durations of therapy relative to Dutch guidelines for the treatment of depression. These findings are consistent with findings in other Dutch, European, and US studies and may present opportunities for quality improvement.

Ambulatory Care↗

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.

Antidepressive Agents↗

A review of methodologies for assessing drug effectiveness and a new proposal: randomized database studies.

The need to evaluate the effects of health technologies in clinical practice is increasingly important. In this article, we review the advantages and limitations of naturalistic randomized clinical trials (RCTs) and database analyses, the two primary methods for evaluating treatment effectiveness. Also, we comment on a newer research strategy, cross-design synthesis, which proposes the complementary use of both experimental RCTs and observational database methodologies to avoid the main weaknesses of each: respectively, the lack of external and internal validity. Finally, we propose a new strategy--randomized database studies--capable of generating results with an acceptable balance between internal and external validity. This strategy consists of the simultaneous use of both experimental and observational tools in the assessment of drugs' effectiveness. Randomization is essential to minimize comparison bias, and one possibility for such studies is that randomization modules could be included in computer-based patient records. Although we identify some of the difficulties in implementing the process, the progressive standardization of clinical practice and the development and widespread adoption of improved computer-based patient records could facilitate the use of randomized database studies as a new method of research.

Economics, Pharmaceutical↗

Prescribing of selective serotonin reuptake inhibitors, anxiolytics, and sedative-hypnotics by general practitioners in The Netherlands: a multivariate analysis.

A study of the prescribing of anxiolytics and sedative-hypnotics and the occurrence of anxiety or sleep disorders before and after the initiation of selective serotonin reuptake inhibitor (SSRI) therapy may provide insight into differences in individual SSRIs. The purpose of our study was to evaluate whether and in what way the likelihood of being prescribed an anxiolytic or sedative-hypnotic or receiving a diagnosis of an anxiety or sleep disorder differed in patients prescribed either fluoxetine or paroxetine by a general practitioner (GP) in the Netherlands, where these two agents are the most commonly prescribed SSRIs. Episodes of SSRI treatment were constructed from a recently available GP database in the Netherlands. Logistic regression analysis was used to determine whether, after controlling for other observable factors, the receipt of paroxetine or fluoxetine was a statistically significant determinant for receipt of an anxiolytic or sedative-hypnotic or a diagnosis of an anxiety or sleep disorder. We found that patients who were prescribed fluoxetine as their index drug were less likely to receive a concomitant sedative-hypnotic on their index date compared with patients receiving paroxetine. After controlling for other observable factors, such as use of anxiolytics and sedative-hypnotics before SSRI therapy or on the index date or the existence of comorbid anxiety or sleep disorders, patients starting fluoxetine therapy were no more likely than patients starting paroxetine therapy to receive an anxiolytic or sedative-hypnotic or a diagnosis of an anxiety or sleep disorder during the 60-day post period. The likelihood of a patient's being diagnosed with or receiving a prescription for an anxiety or sleep disorder does not appear to be a differentiating factor between the prescribing of fluoxetine or paroxetine by GPs in the Netherlands.

Aged↗