Research Topics
| BENJAMIN M DJULBEGOVICSummaryAffiliation: University of South Florida Country: USA Publications
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Publications
At what degree of belief in a research hypothesis is a trial in humans justified?Benjamin Djulbegovic
Interdisciplinary Oncology Programme, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA
J Eval Clin Pract 8:269-76. 2002..The purpose of this study is to determine the degree of uncertainty in a research hypothesis before it can empirically be tested in an RCT...
Screening mammography at 40-49 years: regret or no regret?Benjamin Djulbegovic
H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Department of Interdisciplinary Oncology, Tampa, FL 33612, USA
Lancet 368:2035-7. 2006
Use of re-randomized data in meta-analysisIztok Hozo
Department of Mathematics, Indiana University Northwest, Gary, IN, USA
BMC Med Res Methodol 5:17. 2005..The probability of an event is not always the same when a patient is re-randomized; there is probably a non-zero covariance coming from observations on the same patient. This is of particular importance to the meta-analysts...
Choosing a control intervention for a randomised clinical trialHoward Mann
Department of Radiology, 1A71 University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA
BMC Med Res Methodol 3:7. 2003..The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated...
Estimating the mean and variance from the median, range, and the size of a sampleStela Pudar Hozo
Department of Mathematics, Indiana University Northwest, Gary, IN 46408, USA
BMC Med Res Methodol 5:13. 2005..However, sometimes the published reports of clinical trials only report the median, range and the size of the trial...
Quality and methods of developing practice guidelinesHugh Cruse
H Lee Moffitt Cancer Center and Research Institute, The University of South Florida, Tampa, FL, USA
BMC Health Serv Res 2:1. 2002..It is not known whether there are differences in the quality and recommendations between evidence-based (EB) and consensus-based (CB) guidelines. We used breast cancer guidelines as a case study to assess for these differences...
Erythropoietin, uncertainty principle and cancer related anaemiaOtavio Clark
Interdisciplinary Oncology Program H, Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, FL, USA
BMC Cancer 2:23. 2002..We also wanted to demonstrate that cumulative meta-analysis (CMA) can be used to resolve uncertainty regarding clinical questions...
The uncertainty principle and industry-sponsored researchB Djulbegovic
Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA
Lancet 356:635-8. 2000..Studies in which intervention and control are thought to be non-equivalent violates the uncertainty principle...
Erythropoietin use in oncology: a summary of the evidence and practice guidelines comparing efforts of the Cochrane Review group and Blue Cross/Blue Shield to set up the ASCO/ASH guidelinesBenjamin Djulbegovic
H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Dr, Tampa, FL 33612, USA
Best Pract Res Clin Haematol 18:455-66. 2005..In this paper, the findings from the guidelines set by ASH/ASCO that were culled from systematic reviews by BCBSA TEC and the Cochrane Review are compared and contrasted...
What kind of evidence do patients and practitioners need: evidence profiles based on 5 key evidence-based principles to summarize data on benefits and harmsBenjamin Djulbegovic
Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, 12902 Magnolia Drive, Tampa, FL 33612, USA
Cancer Treat Rev 32:572-6. 2006
Articulating and responding to uncertainties in clinical researchBenjamin Djulbegovic
Department of Interdisciplinary Oncology, University of South Florida, Tampa, Florida 33612, USA
J Med Philos 32:79-98. 2007..That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries...
The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trialsBenjamin Djulbegovic
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Dr, Tampa, FL 33612, USA
Account Res 10:301-15. 2003..We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."..
Acknowledgment of uncertainty: a fundamental means to ensure scientific and ethical validity in clinical researchB Djulbegovic
Interdisciplinary Oncology Program, Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center, University of South Florida, 12902 Magnolia Drive, Tampa, FL 33612, USA
Curr Oncol Rep 3:389-95. 2001..We postulate that about 50% of innovations are successful, leading to the conclusion that preserving the ethics of clinical research may be the best investment strategy available...
Nonmyeloablative allogeneic stem-cell transplantation for hematologic malignancies: a systematic reviewBenjamin Djulbegovic
Malignant Hematology Program, H Lee Moffitt Cancer Center Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, USA
Cancer Control 10:17-41. 2003..They hypothesize that NM-allo-SCT is equally efficacious to standard allo-SCT but produces less regimen-related toxicity...
Management of multiple myeloma: a systematic review and critical appraisal of published studiesAmbuj Kumar
Interdisciplinary Oncology Program of the H Lee Moffitt Cancer and Research Institute, University of South Florida, Tampa, FL 33612, USA
Lancet Oncol 4:293-304. 2003..We conclude that the quality of total evidence supporting treatment recommendations in myeloma is modest at best and has an ample scope for improvement...
A systematic review of quality of life associated with standard chemotherapy regimens for advanced non-small cell lung cancerTawee Tanvetyanon
H Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, Florida 33612, USA
J Thorac Oncol 2:1091-7. 2007..We evaluated available literatures to summarize the state of current knowledge and provide suggestions for future studies...
Systematic review of high dose chemotherapy and autologous haematopoietic stem cell transplantation for chronic lymphocytic leukaemia: what is the published evidence?Mohamed A Kharfan-Dabaja
Division of Blood and Marrow Transplantation, Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Rsearch Institute, University of South Florida, Tampa, FL 33612, USA
Br J Haematol 139:234-42. 2007..It is uncertain whether autograft is superior to conventional therapy. The high incidence of myelodysplastic syndrome (9-12%) is particularly concerning in CLL, where median survival is 9 years...
Epistemologic inquiries in evidence-based medicineBenjamin Djulbegovic
Center for Evidence Based Medicine and Health Outcomes Research and the Clinical Translational Science Institute at the University of South Florida, Tampa, Florida 33612, USA
Cancer Control 16:158-68. 2009..Undertaking epistemological inquiry is important because the adoption of a particular epistemological view defines how science is conducted...
Impact of quality of evidence on the strength of recommendations: an empirical studyBenjamin Djulbegovic
Center for Evidence based Medicine and Health Outcome Research, Clinical Translational Science Institute, Florida, USA
BMC Health Serv Res 9:120. 2009..Surprisingly, and despite the widespread penetration of EBM in health care, there has been no empirical research to date investigating the impact of quality of evidence on the strength of recommendations made by guidelines panels...
The paradox of equipoise: the principle that drives and limits therapeutic discoveries in clinical researchBenjamin Djulbegovic
Center for Evidence Based Medicine and Health Outcomes Research and the Clinical Translational Science Institute, The University of South Florida, Tampa, Florida 33612, USA
Cancer Control 16:342-7. 2009..This guarantee is provided by the acknowledgment of uncertainty (equipoise), which removes ethical dilemmas and makes it easier for patients to enroll in clinical trials...
Management of venous Thromboembolism in cancer: a brief review of risk-benefit approaches and guidelines' recommendationsBenjamin Djulbegovic
Medicine and Oncology, University of South Florida, Tampa, FL 33612, USA
J Support Oncol 8:84-91. 2010..Hence, there is an urgent need to develop a clinical decision-support system that can help integrate benefits and risks as well as take into account patients' preferences and values in managing VTE...
Thalidomide versus bortezomib based regimens as first-line therapy for patients with multiple myeloma: a systematic reviewAmbuj Kumar
Center for Evidence based Medicine and Health Outcome Research, University of South Florida
Am J Hematol 86:18-24. 2011..53, 95% CI 0.38-0.73) favoring MPB. There is an uncertainty about definitive superiority of one type of regimen over the other. Therefore, direct head-to-head comparison between these competing regimens is warranted...
The Australian 'FORM' approach to guideline development: the quest for the perfect systemPhilipp Dahm
Department of Urology and Prostate Disease Center, University of Florida, College of Medicine, Gainesville, FL, USA
BMC Med Res Methodol 11:17. 2011..The Australian National Health and Medical Research Council has developed and pilot-tested a new framework for guideline development, the FORM approach, the role of which has yet to be further defined...
A systematic review and lessons learned from early lung cancer detection trials using low-dose computed tomography of the chestGerold Bepler
Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA
Cancer Control 10:306-14. 2003..Computed tomography (CT) screening of the chest has shown promise for early detection of lung cancer, but evidence for a reduction in lung cancer mortality by CT screening is not available...
Evidence profiles for colo-rectal cancer: benefit/harms data based on the totality of randomized evidenceAmbuj Kumar
H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Department of Interdisciplinary Oncology and Cancer Prevention and Control, 12902 Magnolia Drive, Tampa, FL 33612, USA
Cancer Treat Rev 32:577-80. 2006
Evidence-based medicine for rare diseases: implications for data interpretation and clinical trial designMadhusmita Behera
Malignant Hematology Program, H Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, USA
Cancer Control 14:160-6. 2007..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...
Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology GroupAmbuj Kumar
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL 33612, USA
BMJ 331:1295. 2005....
Tandem versus single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysisAmbuj Kumar
Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA
J Natl Cancer Inst 101:100-6. 2009..We performed a systematic review and meta-analysis to synthesize the existing evidence related to the effectiveness of tandem vs single AHCT in patients with MM...
Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology GroupHeloisa P Soares
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, 12902 Magnolia Drive, Tampa, FL 33612, USA
BMJ 328:22-4. 2004..Reviewing research protocols and contacting trialists for more information may improve quality assessment...
Evidence and decision making. Commentary on M.R. Tonelli (2006), Integrating evidence into clinical practice: an alternative approach to evidence-based approaches. Journal of Evaluation in Clinical Practice 12, 248-256Benjamin Djulbegovic
H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Department of Interdisciplinary Oncology, Tampa, FL, USA
J Eval Clin Pract 12:257-9. 2006
Why evidence based oncology managementAmbuj Kumar
Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL 33612, USA
J Oncol Manag 11:13-6. 2002
When should potentially false research findings be considered acceptable?Benjamin Djulbegovic
Department of Interdisciplinary Oncology, H Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, Florida, United States of America
PLoS Med 4:e26. 2007..Obtaining absolute "truth" in research is impossible, and so society has to decide when less-than-perfect results may become acceptable...
Multiple myeloma: detecting the effects of new treatmentsBenjamin Djulbegovic
Division of Hematologic Malignancies, Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL 33612, USA
Lancet 371:1642-4. 2008
Role of high-dose chemotherapy and autologous hematopoietic cell transplantation in primary systemic amyloidosis: a systematic reviewRahul Mhaskar
Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida 33612, USA
Biol Blood Marrow Transplant 15:893-902. 2009..But the quality of our evidence is low, indicating a need for well-designed and adequately powered RCTs to better address the role of AHCT in AL amyloidosis...
Decision analysis of peripheral blood versus bone marrow hematopoietic stem cells for allogeneic hematopoietic cell transplantationJoseph Pidala
Department of Blood and Marrow Transplantation, Moffitt Cancer Center and Research Institute, Tampa, Florida 33612 9416, USA
Biol Blood Marrow Transplant 15:1415-21. 2009..PBSC is the optimal stem cell source in terms of both overall and quality-adjusted life expectancy, except in conditions with a very low relapse probability, in which BM provides optimal outcomes...
Evaluation of new treatments in radiation oncology: are they better than standard treatments?Heloisa P Soares
H Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa 33612, USA
JAMA 293:970-8. 2005..To describe accurately the outcomes of innovations that are tested in randomized controlled trials (RCTs) 3 factors have to be considered: publication rate, quality of trials, and the choice of the adequate comparator intervention...
Treatment tolerance and efficacy in geriatric oncology: a systematic review of phase III randomized trials conducted by five National Cancer Institute-sponsored cooperative groupsAmbuj Kumar
H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, FL 33612, USA
J Clin Oncol 25:1272-6. 2007..A systematic review to assess the accurate participation of elderly patients in RCTs has not been performed...
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 2006Benjamin Djulbegovic
H Lee Moffitt Cancer Center, 12902 Magnolia Dr, MRC, Room 2067H, Tampa, FL 33612, USA
Arch Intern Med 168:632-42. 2008..We assessed how often experimental cancer treatments that undergo testing in randomized clinical trials (RCTs) result in discovery of successful new interventions...
Farnesyltransferase inhibitor tipifarnib is well tolerated, induces stabilization of disease, and inhibits farnesylation and oncogenic/tumor survival pathways in patients with advanced multiple myelomaMelissa Alsina
Experimental Therapeutics Program, H. Lee Moffitt Cancer Center and Research Institute and Department of Oncology, University of South Florida, Tampa, FL 33612, USA
Blood 103:3271-7. 2004..We conclude that tipifarnib is tolerable, can induce disease stabilization, and can inhibit farnesylation and oncogenic/tumor survival pathways...
Research Grants
- Equipoise and the research integrity of clinical trialsBenjamin Djulbegovic; Fiscal Year: 2003..This proposal will answer both the question "what do trials do for us?" and assess the reliability of the research in which public has invested so much. ..
- Evaluation of the Quality of Clinical TrialsBenjamin Djulbegovic; Fiscal Year: 2006..It is also hoped that public confidence in COG research may further increase, which in turn will enable development of more rapid advances in the war against cancer. ..
- Quality of Research on Treatment Harms in CancerBenjamin Djulbegovic; Fiscal Year: 2007..Finally, the improvement of the reporting of harms would benefit physicians and above all patients, who need to understand the potential harms of the treatments they receive. ..
