Measuring Clinical Effectiveness: METHODOLOGY

Mix Measurement

Comparing the effects of two drugs on patient-care costs and outcomes requires adjusting for differences in the clinical conditions of patients. The CEI started with the standard Diagnosis-Related Groups (DRGs), which are used nationally in the Medicare Prospective Payment System (PPS). Modifications were made to tailor these DRGs to the needs of the class of drugs being studied—anticoagulants in this study—and referred to as CEI-DRGs.

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Measuring Clinical Effectiveness

Clinical EffectivenessBACKGROUND AND NEED

Contemporary issues facing institutional managers, as well as P&T committee members, focus heavily on balancing patient care costs and outcomes. That balance should assist organizations in achieving their value propositions in providing optimal patient care—in this case, through the appropriate use of pharmaceutical agents. Achieving a balance requires informed decision-making along with access to the appropriate data that will assist in assessing both cost and outcomes.

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American Society of Clinical Oncology: Oral Drug Combination for Multiple Myeloma

Oral Drug CombinationSpeaker: Vincent Rajkumar, MD, Hematologist, Mayo Clinic, Rochester, Minnesota.

Patients with newly diagnosed multiple myeloma responded better to treatment with the oral drug combination of thalidomide (Thalomid®, Celgene) plus dexamethasone (Decadron generic, Merck) (thal/dex) than to dexamethasone therapy alone.

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American Society of Clinical Oncology: Oral Fluoropyrimidine for Metastatic Colon Cancer

Speaker: Joseph J. McKendrick, MD, Director of Medical Oncology, Department of Clinical Hematology and Clinical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.

Adjuvant chemotherapy with oral capecitabine (Xeloda®, Roche), an oral fluoropyrimidine preferentially activated to 5-fluorouracil (5-FU) in tumors by enzymatic action, was more cost-effective than the standard Mayo Clinic regimen of IV 5-FU and leucovorin (LV) in the adjuvant treatment of meta-static colon cancer.

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American Society of Clinical Oncology: Chemotherapy and Radiation Therapy in Glioblastoma Multiforme

Speaker: Roger Stupp, MD, Professor of Medicine and Director, Brain Tumor and Chest Oncology Clinic, Multi-disciplinary Oncology Center, University of Lausanne Hospital, Vaudois, Lausanne, Switzerland.

The addition of temozolomide (Temodar®, Schering), a chemotherapeutic agent indicated for the treatment of ana-plastic astrocytoma, to standard radiation therapy significantly improved both progression-free survival and overall survival in patients with glioblastoma multiforme, a fast-growing primary brain tumor that is difficult to treat.

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American Society of Clinical Oncology

Clinical OncologyNanoparticle Albumin-Bound Paclitaxel for Metastatic Breast Cancer

Speaker: William J. Gradishar, MD, Associate Professor of Medicine; Director, Breast Oncology; and Director, Fellowship Program, Division of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

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Advocates Pursue: BENEFITS AND DRAWBACKS OF PUBLIC DISCLOSURE

Proponents point to a range of benefits to be gained from public disclosure of all clinical trial results. The most obvious advantage is the increased transparency of findings that suggest health risks or questionable efficacy of a medication. Patients and physicians would have a more powerful tool to compare different drugs for similar medical conditions. Registry data could also help investigators to design future trials more efficiently, perhaps enabling them to use fewer subjects and simpler protocols by targeting their research.

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