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Perspective
The Risks and Benefits of 5α-Reductase Inhibitors for Prostate-Cancer Prevention
The use of 5α-reductase inhibitors for prevention of prostate cancer continues to be widely discussed within the scientific and medical communities. Much of this discussion has been fueled by the findings of two large randomized, placebo-controlled trials — the Prostate Cancer Prevention Trial…
- July 14, 2011
- Theoret M.R., Ning Y.-M., Zhang J.J., et al.
- N Engl J Med 2011; 365:97-99
- Free Full Text
5α-reductase inhibitors' potential benefits in preventing prostate cancer and potential increased risk for high-grade cancers have been central issues for the FDA, which convened its Oncologic Drugs Advisory Committee to address the topic last December.
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Editorial
Meaningful Placebos — Controlling the Uncontrollable
In this issue of the Journal, Wechsler et al. report data from a study that compared four interventions involving patients with asthma (ClinicalTrials.gov number, NCT01143688). They found that three of the interventions — active albuterol, sham albuterol, and sham acupuncture — were all equally…
- July 14, 2011
- Moerman D.E.
- N Engl J Med 2011; 365:171-172
In this issue of the Journal, Wechsler et al.¹ report data from a study that compared four interventions involving patients with asthma (ClinicalTrials.gov number, NCT01143688). They found that three of the interventions — active albuterol, sham albuterol,...
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Perspective
Assessing the Safety of Adding LABAs to Inhaled Corticosteroids for Treating Asthma
Long-acting beta-agonists (LABAs) — drugs that provide bronchodilation for 12 hours or longer by stimulating the β2-adrenergic receptor — have been associated with serious adverse asthma outcomes such as asthma-related hospitalization, need for intubation, and even death in some patients. In…
- June 30, 2011
- Chowdhury B.A., Seymour S.M., Levenson M.S.
- N Engl J Med 2011; 364:2473-2475
The FDA has issued a requirement for manufacturers of long-acting beta-agonists (LABAs) marketed for asthma to conduct controlled clinical trials to assess the safety of a regimen of LABAs plus inhaled corticosteroids as compared with inhaled corticosteroids alone.
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Original Article
Leukotriene Antagonists as First-Line or Add-on Asthma-Controller Therapy
Results of double-blind, randomized, controlled trials provide, appropriately, the bedrock of evidence in determining the efficacy of therapeutic interventions. Proof of efficacy in the trial setting of optimized adherence and follow-up for selective patient populations does not, however, guarantee…
- May 5, 2011
- Price D., Musgrave S.D., Shepstone L., et al.
- N Engl J Med 2011; 364:1695-1707
- Free Full Text
In this pragmatic trial, patients with asthma who required first-line controller therapy or were already using an inhaled glucocorticoid and needed additional therapy received a leukotriene-receptor antagonist (LTRA) or an inhaled glucocorticoid as first-line treatment or an LTRA or a long-acting beta₂-agonist as an add-on.
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Perspective
Statistics in Medicine: Pragmatic Trials — Guides to Better Patient Care?
Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients' and clinicians' actual…
- May 5, 2011
- Ware J.H. and Hamel M.B.
- N Engl J Med 2011; 364:1685-1687
Because of concerns about the real-world applicability of clinical trials and about improving the quality and value of health care, “pragmatic” trials are attracting increasing attention. These trials have both important strengths and inherent limitations.
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Perspective
Collaborative Clinical Trials
Ongoing improvement in health care requires, among other things, the introduction of new therapies that have been evaluated in clinical trials. Unfortunately, the clinical trial environment is facing a crisis, produced by burgeoning costs, burdensome regulatory requirements, and other factors that…
- March 3, 2011
- Moss A.J., Francis C.W., Ryan D.
- N Engl J Med 2011; 364:789-791
Burgeoning costs, burdensome regulatory requirements, and other factors are reducing the likelihood of successfully completing pivotal clinical trials. Conducting clinical trials in a collaborative manner would overcome many of these problems.
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Special Article
Variability in the Measurement of Hospital-wide Mortality Rates
Hospital-performance metrics are increasingly used for value-based purchasing and public reporting. For example, Section 3001 of the Patient Protection and Affordable Care Act mandates incentive payments to hospitals that meet quality performance standards, which remain unspecified. In 2008, the…
- December 23, 2010
- Shahian D.M., Wolf R.E., Iezzoni L.I., Kirle L., Normand S.-L.T.
- N Engl J Med 2010; 363:2530-2539
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This study showed that four commonly used methods to calculate hospitals' risk-adjusted rates of death produced different results. The same hospitals were classified as having higher-than-expected mortality by one method and lower-than-expected mortality by other methods.
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Perspective
Public Release of Clinical Outcomes Data — Online CABG Report Cards
On September 7, 2010, Consumers Union (publisher of Consumer Reports) reported the results of coronary-artery bypass grafting (CABG) procedures at 221 U.S. cardiac surgery programs. The voluntary reporting of risk-adjusted outcomes in approximately 20% of U.S. cardiac surgery programs is a…
- October 21, 2010
- Ferris T.G. and Torchiana D.F.
- N Engl J Med 2010; 363:1593-1595
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On September 7, 2010, Consumers Union (publisher of Consumer Reports) reported the results of coronary-artery bypass grafting (CABG) procedures at 221 U.S. cardiac surgery programs.¹ The voluntary reporting of risk-adjusted outcomes in approximately 20% ...
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Statistics in Medicine
The Delayed-Start Study Design
To advance our understanding of treatments for diseases that progress slowly but that are ultimately debilitating, such as Alzheimer's disease, Parkinson's disease, rheumatoid arthritis, and chronic obstructive pulmonary disease, it is essential to evaluate the disease-modifying effects of…
- September 24, 2009
- D'Agostino R.B.
- N Engl J Med 2009; 361:1304-1306
Delayed-start study designs are a new way to distinguish a treatment's effects on long-term disease progression from its potential short-term effects on disease symptoms. In this article, the strengths, weaknesses, and key design assumptions of this type of trial are examined.
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Correspondence
Calculation of Number Needed to Treat
To the Editor: The number of patients who would need to be treated to prevent a given adverse outcome in one patient, called the number needed to treat, is often used in randomized trials and observational studies to provide a simple measure of the effect of a treatment. The computation of the…
- July 23, 2009
- N Engl J Med 2009; 361:424-425
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To the Editor: The number of patients who would need to be treated to prevent a given adverse outcome in one patient, called the number needed to treat, is often used in randomized trials and observational studies to provide a simple measure of the ...
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Perspective
Redefining Quality — Implications of Recent Clinical Trials
Simple approaches to patient care are better — except when they are not. Recent clinical studies are leading to a reexamination of the paradigm whereby efforts to prevent vascular disease focus on the achievement of particular levels of risk factors such as low-density lipoprotein (LDL)…
- June 12, 2008
- Krumholz H.M. and Lee T.H.
- N Engl J Med 2008; 358:2537-2539
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The conventional wisdom for guidelines and performance measures has been that the clinician's key focus ought to be on reducing risk factors below specific levels. Drs. Harlan Krumholz and Thomas Lee argue that this approach neglects the importance of ...
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Correspondence
More on Subgroup Analyses in Clinical Trials
To the Editor: With regard to the article by Wang et al. (Nov. 22 issue), it is increasingly recognized that subgroup analyses in clinical trials are sometimes misused and require appropriate presentation and cautious interpretation. However, we would recommend that one type of subgroup analysis…
- May 8, 2008
- N Engl J Med 2008; 358:2076-2077
- Free Full Text
To the Editor: With regard to the article by Wang et al. (Nov. 22 issue), it is increasingly recognized that subgroup analyses in clinical trials are sometimes misused and require appropriate presentation and cautious interpretation.¹,² However, we would ...
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Correspondence
Subgroup Analyses in Clinical Trials
To the Editor: Wang et al. (Nov. 22 issue) provide a well-reasoned assessment of the statistical issues related to subgroup analyses. However, one important point that should be made is that significance testing during subgroup analyses is seldom appropriate. The majority of subgroup analyses are…
- March 13, 2008
- N Engl J Med 2008; 358:1199-1200
- Free Full Text
To the Editor: Wang et al. (Nov. 22 issue)¹ provide a well-reasoned assessment of the statistical issues related to subgroup analyses. However, one important point that should be made is that significance testing during subgroup analyses is seldom ...
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Perspective
In Defense of Pharmacoepidemiology — Embracing the Yin and Yang of Drug Research
The past decade has not been kind to observational studies of medications. The damage began in 1998 with the publication of the Heart and Estrogen–Progestin Replacement Study, a randomized controlled trial showing that hormone replacement increased the risk of cardiac events among postmenopausal…
- November 29, 2007
- Avorn J.
- N Engl J Med 2007; 357:2219-2221
The past decade has not been kind to observational studies of medications. Dr. Jerry Avorn writes that, when done correctly, epidemiologic studies of drug effects can be more powerful than the average randomized, controlled trial, especially in assessing ...
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Special Report
Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials
Medical research relies on clinical trials to assess therapeutic benefits. Because of the effort and cost involved in these studies, investigators frequently use analyses of subgroups of study participants to extract as much information as possible. Such analyses, which assess the heterogeneity of…
- November 22, 2007
- Wang R., Lagakos S.W., Ware J.H., Hunter D.J., Drazen J.M.
- N Engl J Med 2007; 357:2189-2194
- Free Full Text
The analysis of subgroups is often used as a way to glean additional information from data sets. The strengths and weaknesses of this approach and new Journal policies concerning the reporting of subgroup analyses are discussed in this article.
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Perspective
Statistics and Medicine: Drinking from the Fire Hose — Statistical Issues in Genomewide Association Studies
The past 3 months have seen the publication of a series of studies examining the inherited genetic underpinnings of common diseases such as prostate cancer, breast cancer, diabetes, and in this issue of the Journal, coronary artery disease (reported by Samani et al. pages 443–453). These…
- August 2, 2007
- Hunter D.J. and Kraft P.
- N Engl J Med 2007; 357:436-439
Genomewide association studies have been able to examine interpatient differences in inherited genetic variability at an unprecedented level of resolution. David Hunter and Peter Kraft discuss the chief strengths and problems of this new approach.
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Perspective
Statistics and Medicine: Challenges in Using Observational Studies to Evaluate Adverse Effects of Treatment
In this issue of the Journal, Friis-Møller and colleagues (pages 1723–1735) report on results from a prospective observational study involving more than 23,000 patients infected with HIV. The study, called the Data Collection on Adverse Effects of Anti-HIV Drugs (DAD) trial, identified a…
- April 26, 2007
- Hughes M.D. and Williams P.L.
- N Engl J Med 2007; 356:1705-1707
Because randomized studies are rarely well powered for evaluating adverse effects of treatment, well-designed observational studies are important. Michael Hughes and Paige Williams discuss the complex questions concerning both the potential confounding of ...
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Perspective
Statistics and Medicine: The Limitations of Risk Factors as Prognostic Tools
Identification of new risk factors for specific diseases is an enduring theme in medical research. Advances in molecular biology, genetics, and computational biology are accelerating the pace of this work. The research seeks to increase our understanding of the causes of diseases, but there is also…
- December 21, 2006
- Ware J.H.
- N Engl J Med 2006; 355:2615-2617
Research has shown that a risk factor must have a much stronger association with the disease outcome than we ordinarily see in etiologic research if it is to provide a basis for early diagnosis or prediction in individual patients. James Ware explains the ...
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Perspective
Dangerous Deception — Hiding the Evidence of Adverse Drug Effects
September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and the company withdrew the drug from the market after 5 years of use in more than 20 million patients. On September 30, 2006,…
- November 23, 2006
- Avorn J.
- N Engl J Med 2006; 355:2169-2171
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- Audio
On September 30, the New York Times reported that the FDA had issued a warning that the antifibrinolytic drug aprotinin could cause renal failure, congestive heart failure, stroke, and death. Dr. Jerry Avorn writes that many aspects of the aprotinin saga ...
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Perspective
Statistics and Medicine: Time-to-Event Analyses for Long-Term Treatments — The APPROVe Trial
The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial compared rofecoxib with placebo in the prevention of recurrent colorectal polyps, but the researchers also collected data on adverse cardiovascular events, including confirmed serious thrombotic events. Assessment of the cardiovascular data…
- July 13, 2006
- Lagakos S.W.
- N Engl J Med 2006; 355:113-117
Assessment of the cardiovascular data from the APPROVe trial raises important issues about the analysis and interpretation of a time-to-event end point in a randomized, placebo-controlled trial evaluating a long-term treatment. Stephen Lagakos explains.
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Medical Meetings Pediatrics Conferences and Meetings

2012 Certifying Examinations of the American Board of Pediatrics

The general pediatrics examination will be held in various cities, Oct. 16-18. Registration for first-time applicants is ongoing through May 3. Registration for re-registrants is ongoing through May 24. The following subspecialty examinations will be held in various cities: "Hospice and Palliative Medicine" (Oct. 4); "Pediatric Transplant Hepatology" (Oct. 11); "Pediatric Cardiology" (Nov. 7); "Pediatric Pulmonology" (Nov. 8); "Medical Toxicology" (Nov. 12); and "Pediatric Critical Care Medicine" (Nov. 14). Registration for first-time applicants is ongoing through April 30. Registration for re-registrants is ongoing through June 15.

Contact the American Board of Pediatrics, 111 Silver Cedar Court, Chapel Hill, NC 27514-1513; or call (919) 929-0461; or fax (919) 918-7114 or (919) 929-9255; or see http://www.abp.org .

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