When is diagnostic testing inappropriate or irrational? Acceptable regret approach.

The authors provide a new model within the framework of theories of bounded rationality for the observed physicians' behavior that their ordering of diagnostic tests may not be rational. Contrary to the prevailing thinking, the authors find that physicians do not act irrationally or inappropriately when they order diagnostic tests in usual clinical practice. When acceptable regret (i.

Treatment success in cancer: new cancer treatment successes identified in phase 3 randomized controlled trials conducted by the National Cancer Institute-sponsored cooperative oncology groups, 1955 to 2006.

Background: The evaluation of research output, such as estimation of the proportion of treatment successes, is of ethical, scientific, and public importance but has rarely been evaluated systematically. We assessed how often experimental cancer treatments that undergo testing in randomized clinical trials (RCTs) result in discovery of successful new interventions.

Methods: We extracted data from all completed (published and unpublished) phase 3 RCTs conducted by the National Cancer Institute cooperative groups since their inception in 1955.

Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia.

Context: The erythropoiesis-stimulating agents (ESAs) erythropoietin and darbepoetin are licensed to treat chemotherapy-associated anemia in patients with nonmyeloid malignancies. Although systematic overviews of trials have identified venous thromboembolism (VTE) risks, none have identified mortality risks with ESAs.

Objective: To evaluate VTE and mortality rates associated with ESA administration for the treatment of anemia among patients with cancer.

Recommendations on the use of 18F-FDG PET in oncology.

Unlabelled: The rationale was to develop recommendations on the use of (18)F-FDG PET in breast, colorectal, esophageal, head and neck, lung, pancreatic, and thyroid cancer; lymphoma, melanoma, and sarcoma; and unknown primary tumor. Outcomes of interest included the use of (18)F-FDG PET for diagnosing, staging, and detecting the recurrence or progression of cancer.

Methods: A search was performed to identify all published randomized controlled trials and systematic reviews in the literature.

A systematic review of quality of life associated with standard chemotherapy regimens for advanced non-small cell lung cancer.

Purpose: Systemic chemotherapy is accepted as a standard of care for patients with advanced non-small cell lung cancer (NSCLC). Although survival outcomes are equivalent among standard chemotherapy regimens, it is unknown whether the quality of life (QOL) outcomes are also comparable. We evaluated available literatures to summarize the state of current knowledge and provide suggestions for future studies.

Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update.

Purpose: To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents.

Method: An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007.

Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update.

Purpose: To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents.

Method: An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007.

Systematic review of high dose chemotherapy and autologous haematopoietic stem cell transplantation for chronic lymphocytic leukaemia: what is the published evidence?

Despite improved responses, chronic lymphocytic leukaemia (CLL) remains incurable with conventional chemotherapy. Patients with poor-risk factors or who fail conventional chemoimmunotherapy are offered autografts, preferably after achieving remission. This report presents the totality of evidence through a systematic review that assessed the efficacy of autografts in CLL.

Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers.

Background: The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data mining of databases. In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases.

Articulating and responding to uncertainties in clinical research.

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified.

Treatment tolerance and efficacy in geriatric oncology: a systematic review of phase III randomized trials conducted by five National Cancer Institute-sponsored cooperative groups.

Purpose: Elderly patients share the majority of the disease burden in cancer. Although 61% of new cancer cases occur among elderly, they comprise only 25% of the patients enrolled onto randomized clinical trials (RCTs). A systematic review to assess the accurate participation of elderly patients in RCTs has not been performed.

Evidence-based medicine for rare diseases: implications for data interpretation and clinical trial design.

Background: The randomized, controlled trial (RCT) is the "gold standard" for establishing the effect of any intervention. This approach, however, is often not feasible with rare diseases such as cutaneous T-cell lymphoma.

Methods: We review the principles of evidence-based medicine to see which are particularly pertinent to the study of rare diseases.

When should potentially false research findings be considered acceptable?

Ioannidis estimated that most published research findings are false, but he did not indicate when, if at all, potentially false research results may be considered as acceptable to society. We combined our two previously published models to calculate the probability above which research findings may become acceptable. A new model indicates that the probability above which research results should be accepted depends on the expected payback from the research (the benefits) and the inadvertent consequences (the harms).

High-dose therapy with single autologous transplantation versus chemotherapy for newly diagnosed multiple myeloma: A systematic review and meta-analysis of randomized controlled trials.

Myeloablative high-dose therapy and single autologous stem cell transplantation (HDT) is frequently performed early in the course of multiple myeloma, supported by some randomized controlled trials (RCTs) indicating overall survival (OS) and progression-free survival (PFS) benefit compared with nonmyeloablative standard-dose therapy (SDT). Other RCTs, however, suggest variable benefit. We therefore undertook a systematic review and meta-analysis of all RCTs evaluating upfront HDT versus SDT in myeloma.

Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Purpose: Evaluate response rate, duration of response (DOR), time-to-progression (TTP), overall survival (OS), and safety of bortezomib treatment in patients with relapsed or refractory mantle cell lymphoma (MCL).

Patients And Methods: Bortezomib 1.3 mg/m(2) was administered on days 1, 4, 8, and 11 of a 21-day cycle, for up to 17 cycles.