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Effectiveness Study (effectiveness + study)
Selected AbstractsComparison of the metabolic and economic consequences of long-term treatment of schizophrenia using ziprasidone, olanzapine, quetiapine and risperidone in Canada: a cost-effectiveness analysisJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 4 2010Roger S. McIntyre MD FRCPC Abstract Rationale, aims and objectives, Second-generation antipsychotic agents have varying propensities to cause weight gain, elevated lipid levels and associated long-term complications. This study evaluates the cost-effectiveness of four second-generation antipsychotic agents used in Canada for the treatment of schizophrenia (ziprasidone, olanzapine, quetiapine, risperidone) with a focus on their long-term metabolic consequences. Method, Using data from the Clinical Antipsychotic Trials of Intervention Effectiveness Study, a semi-Markov model was developed to predict the incidence and associated costs of type 2 diabetes, cardiovascular complications (e.g. angina, myocardial infarction, stroke, cardiovascular disease death), and acute psychiatric hospitalizations in patients with chronic schizophrenia treated over 5 years. Incremental costs per quality-adjusted life year (QALY) gained were calculated from the perspective of the Canadian provincial ministries of health. Scenario and probabilistic sensitivity analyses were performed. Results, The total average cost of treatment with ziprasidone was $25 301 versus $28 563 with olanzapine, $26 233 with quetiapine and $21 831 with risperidone. Ziprasidone had the lowest predicted number of type 2 diabetes cases and cardiovascular disease events, and the highest QALY gains. Patients receiving quetiapine had the highest predicted number of hospitalizations. Ziprasidone was less costly and resulted in more QALYs compared with olanzapine and quetiapine. Compared with risperidone, ziprasidone was more costly and had higher QALYs, with an incremental cost per QALY gained of $218 060. Conclusion, Compared with olanzapine and quetiapine, ziprasidone produced savings to the health care system. Although ziprasidone generated incremental expenditures versus risperidone, it resulted in more QALYs. Based on this analysis, ziprasidone treatment possesses cost and therapeutic advantages compared with olanzapine and quetiapine. [source] Fine-needle aspiration of primary osseous lesions: A cost effectiveness studyDIAGNOSTIC CYTOPATHOLOGY, Issue 4 2010Lester J. Layfield M.D. Abstract Fine-needle aspiration (FNA) is not widely used in the work-up of osseous lesions because of concerns regarding its high incidence of nondiagnostic specimens. Although several studies have shown that FNA is less expensive than surgical biopsy, the authors are aware of only one prior study evaluating the cost effectiveness of FNA, which includes the cost of incisional or core needle biopsies necessary to establish a diagnosis when the initial FNA was noncontributory. A computerized search of the pathology records of three medical centers was performed to obtain all FNAs of primary osseous lesions. For each FNA case, all subsequent core needle, incisional or excisional biopsies were recorded as was the result of the definitive operative procedure. The cost of obtaining the definitive diagnosis was calculated for each case including the cost of FNA, imaging guidance utilized, and cost of subsequent surgical biopsy when necessary. The cost of an alternate approach using only surgical biopsy was calculated. The average per patient costs of these two protocols were compared. A total of 165 primary bone tumors underwent FNA. One hundred six of these yielded a definitive cytologic diagnosis. In 59 cases, FNA yielded a result insufficient for definitive therapy necessitating surgical biopsy. FNA investigation of the 165 bone lesions cost 575,932 (average of 3,490 per patient). Surgical biopsy alone would have cost 5,760 per patient. FNA resulted in a cost savings of 2,215 per patient. Diagn. Cytopathol. 2010 © 2009 Wiley-Liss, Inc. [source] An Open-Label Study of the Lidocaine Patch 5% in Painful Idiopathic Sensory PolyneuropathyPAIN MEDICINE, Issue 5 2005David N. Herrmann MBBCh ABSTRACT Objective., Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy. Design., A prospective open-label, flexible dosing, 3-week study period with a 5-week extension. Setting., Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility. Patients., Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of ,4 on a visual analog scale. Intervention., Lidocaine patch 5%, maximum of four patches daily for 18 hours. Main Outcome Measure., Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures. Results., Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated. Conclusions., The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies. [source] Using medical records to supplement a claims-based comparative effectiveness analysis of antidepressants,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2010Thomas W. Croghan Abstract Purpose Because health insurance claims lack clinical information, comparative effectiveness research studies that rely on these data may be challenging to interpret and may result in biased inference. We conducted an exploratory study to determine if medical information contained in patient charts could offer clinical details that would assist in interpreting the results of a claims-based comparative effectiveness study of selective serotonin reuptake inhibitors (SSRIs). Methods Retrospective review of 457 charts of patients initiating SSRI treatment. Descriptive data elements included patient diagnosis, symptoms of depressive and anxiety disorders, provider's assessment, and medication treatment and side effects. Results Most subjects were excluded from the study because their charts were not accessible (58.7%), they did not have a follow-up visit (55.6%), providers could not be contacted (58.0%), or providers refused participation in the study (36.5%). Among those included in the study, most patients were noted to have depression, but most charts lacked information on the majority of depression symptoms at baseline and follow-up. Few concomitant symptoms, side effects, and other important clinical and treatment characteristics were recorded. Conclusions Inability to obtain charts due to plan or provider refusal, lack of available information in charts at key times in the course of illness, and missing data elements posed considerable challenges and prevented firm conclusions beyond those drawn from the parent, claims-based study. Copyright © 2010 John Wiley & Sons, Ltd. [source] Integrating Tobacco Cessation Treatment into Mental Health Care for Patients with Posttraumatic Stress DisorderTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 5 2006Miles McFall PhD The integration of tobacco cessation treatment into mental health care for posttraumatic stress disorder (PTSD), known as Integrated Care (IC), was evaluated in an uncontrolled feasibility and effectiveness study. Veterans (N = 107) in PTSD treatment at two outpatient clinics received IC delivered by mental health practitioners. Outcomes were seven-day point prevalence abstinence measured at two, four, six, and nine months post-enrollment and repeated seven-day point prevalence abstinence (RPPA) obtained across three consecutive assessment intervals (four, six, and nine months). Abstinence rates at the four assessment intervals were 28%, 23%, 25%, and 18%, respectively, and RPPA was 15%. The number of IC sessions and a previous quit history greater than six months predicted RPPA. Stopping smoking was not associated with worsening PTSD or depression. [source] The economic consequences of introducing deep brain stimulation for the treatment of advanced Parkinson's disease in AustraliaAUSTRALASIAN JOURNAL ON AGEING, Issue 3 2003Bruce P. Hollingsworth Objectives: Parkinson's disease is a debilitating condition, which is increasing in prevalence as elderly populations increase in the developed world. As such, resource consumption will also increase. For advanced Parkinsons, where drug therapy is no longer effective, there are two surgical options - ablative surgery, a one-off procedure which destroys part of the brain, and deep brain stimulation (DBS), which uses electrodes to stimulate part of the brain. The specific question to be answered here is what the costs to the community of DBS are compared to ablative surgery (thalmotomy or pallidotomy) in potentially relieving the symptoms of advanced Parkinson's disease, and if there is any improvement in patients' quality of life. Design: A cost effectiveness study is undertaken. UK and Australian data are made use of and cost-effectiveness estimated in terms of cost per change in functional ability. Setting: Hospital, community and home care. Patients: Those with advanced Parkinson's Disease. Main outcome measures: Frenchay index of functional ability. Results: It is estimated that the incremental extra cost for a small change in ability to undertake daily tasks is at least 23,559. Conclusions: As outcomes evidence is of low quality, at this stage it is not possible to establish that Deep Brain Stimulation offers substantial improvements in quality of life. Extra costs over ablative surgery are estimated to be in the range of 17,830 to 51,385 per patient over a five year period. [source] Lamotrigine versus lithium as maintenance treatment in bipolar I disorder: an open, randomized effectiveness study mimicking clinical practice.BIPOLAR DISORDERS, Issue 5 2010The 6th trial of the Danish University Antidepressant Group (DUAG-6) Licht RW, Nielsen JN, Gram LF, Vestergaard P, Bendz H. Lamotrigine versus lithium as maintenance treatment in bipolar I disorder: an open, randomized effectiveness study mimicking clinical practice. The 6th trial of the Danish University Antidepressant Group (DUAG-6). Bipolar Disord 2010: 12: 483,493. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objectives:, In industry-generated pivotal studies, lamotrigine has been found to be superior to placebo and comparable to lithium in the maintenance treatment of bipolar I disorder. Here, we directly compared lamotrigine to lithium under conditions similar to clinical routine conditions. Methods:, Adult bipolar I disorder patients with at least two episodes within the last five years and an index episode requiring treatment were randomized to lithium (n = 78; doses adjusted to obtain serum levels of 0.5,1.0 mmol/L) or to lamotrigine (n = 77; up-titrated to 400 mg/day) as maintenance treatments. Randomization took place when clinically appropriate, and comedication was allowed within the first six months after randomization. The patients were enrolled from March 2001 to December 2005, and observations were censored December 2006, allowing a subgroup of patients to be followed for more than five years. The primary outcome measure was time to predefined endpoints indicating insufficient maintenance treatment, and the major secondary outcome measure was time to any study endpoint. Data were analyzed primarily by Cox proportional regression models. Results:, For the primary outcome measure, the crude Hazard Rate Ratio (HRR) (lamotrigine relative to lithium) was 0.92 [95% confidence interval (CI): 0.60,1.40]. When the primary endpoints were broken down by polarity, the HRRs (lamotrigine relative to lithium) for mania and depression were, respectively, 1.91 (95% CI: 0.73,5.04) and 0.69 (95% CI: 0.41,1.22). There was no between-group difference in terms of staying in study [HRR: 0.85 (95% CI: 0.61,1.19)]. Most treatment failures occurred within the first 1.5 years of treatment, and, among patients followed for at least five years, practically no patients were maintained successfully on monotherapy with either of the drugs. The lithium-treated patients reported diarrhea, tremor, polyuria, and thirst more frequently. Two cases, probably lamotrigine-related, of benign rash occurred. Conclusions:, No differences in maintenance effectiveness between lithium and lamotrigine could be demonstrated. Lamotrigine was better tolerated than lithium, but apparently this did not influence the outcome. [source] | ||||||||||