Alert and Oriented

The clinical trial on trial

Michel AccadJuly 21, 2011December 13, 2016Medical science, Philosophyclinical trials, randomized clinical trial, statistics, statistics in medicine1 Comment

It is the mark of an educated man to look for precision in each class of things just so far as the nature of the subject admits.

Aristotle

UK gastroenterologist and fellow contrarian James Penston has published two books critical of mainstream clinical research methodology. The most recent one, called Stats.con, deals with the misuse of statistics in medicine and expands on the topic of his first book published in 2003 under the title Fiction and Fantasy in Medical Research: The Large-Scale Randomised Trial.Continue reading “The clinical trial on trial”

Huff-puff: previously known as “diastolic” heart failure

Michel AccadJuly 18, 2011December 13, 2016Medical sciencecardiology, diastolic heart failure, heart failureLeave a comment

This week’s JACC offers an excellent paper by Kitzman and co-workers on what is now called “Heart Failure with Preserved Ejection Fraction,” or HFPEF, (or huff-puff…).

The article reports on the cardiopulmonary physiology of 48 patients with “pure” huff-puff (no amyloid or hypertrophic cardiomyopathy) compared to 25 healthy controls. All were subjected to measurement of VO2 max and echocardiography, and the echo-derived cardiac output estimate was validated (to a reasonable extent) by radionuclide angiography.

The findings were surprising but confirm some earlier studies: Huff-puff does not seem to be due to an inability to expand diastolic volume (although end-diastolic volume at rest is decreased in Huff-puff compared to controls). Key pathophysiologic components seem to be 1) inability to increase heart rate with exercise (chronotropic incompetence); 2) inability to reduce end-systolic volume at peak exercise (yielding a relatively lower stroke volume, likely due to decreased contractility); 3) some peripheral phenomenon that interferes with oxygen extraction (calculated A-v O2 difference was reduced at peak exercise in huff-puff patients).

The accompanying editorial also offers a helpful review on the subject and on the evolution of the nomenclature.

A key unanswered question/speculation regards the role of calcium-channel blockers in this condition and to a lesser extent, beta-blockers. Both are currently “class IIb” therapies for huff-puff.

The Statistical Alchemy of Meta-Analyses

Michel AccadJuly 11, 2011December 13, 2016Healthcare policy, Medical scienceclinical research, clinical trials, medical statistics, meta-analysis, randomized controlled trials, statistics, statistics in medicine2 Comments

A recent post by Dr. Wes reminded me of the remarkable article Alvan Feinstein wrote in 1995 “Meta-Analysis: Statistical Alchemy for the 21st Century.” In a few clearly written pages, the founding father of clinical epidemiology brilliantly identifies the wishful thinking underlying meta-analysis and exposes its methodological fallacies.Continue reading “The Statistical Alchemy of Meta-Analyses”

Gotta love them data!

Michel AccadJuly 5, 2011April 14, 2015Medical scienceLeave a comment

Drs. Marc Pfeffer and Marianne Bowler are commenting on the Supreme Court’s ruling in Matrixx vs. Siracusano, which upheld a lower court’s decision that a drug manufacturer must disclose to shareholders information regarding adverse effects, even absent any measure of statistical significance. But the authors would like to go beyond the court’s mandate. They advocate for “more open and better reporting” of any potential adverse effects (calling for drug companies to deliver any available piece of information “transparently,” e.g. directly to their desktop).Continue reading “Gotta love them data!”

Database doctors form new board

Michel AccadJuly 5, 2011December 13, 2016Medical scienceLeave a comment

CHICAGO—June 16, 2011—The American Board of Medical Specialties (ABMS) has announced the creation of a new certifying body, the American Board of Database Medicine (ABDM). The announcement was made jointly by ABMS and the American Association of Database Doctors (AADD), the leading professional organization representing database medicine specialists.

“The last decades have witnessed an unprecedented epidemic of data,” said Dr. Numbar Kruntsher, president of AADD. “Studies are published everyday, and new data is produced before the old data is even digested. Thankfully, growing numbers of dedicated physicians have stepped forward to help manage data by harnessing the power of statistics and information technology. We are delighted this work is getting the recognition it deserves, and we are confident the certification pathway will ensure that data will continue to receive the high quality of care the public has come to expect.”Continue reading “Database doctors form new board”

Adiposopathy: is the evidence too thin?

Michel AccadJuly 2, 2011December 13, 2016Medical scienceadiposopathy, disease definition, fat, nosology, obesity, war on fatLeave a comment

In the June 21 issue of JACC, Dr. Harold E. Bays argues for establishing “adiposopathy” as a full-fledged disease to provide a coherent understanding of the role of fat tissue in cardiovascular disease, dispel the confusion related to the many-named “metabolic syndrome,” and resolve the obesity paradox. Does he succeed in this task? What would Virchow have to say?Continue reading “Adiposopathy: is the evidence too thin?”

CER and MCC: a marriage made in DC

Michel AccadJune 30, 2011December 13, 2016Healthcare policyLeave a comment

The NEJM has just published another promotional piece on “Comparative Effectiveness Research” in its on-going series on health policy and reform. But this time, behind the usual grandiose claims of CER, authors Tinetti and Studenski betray a certain tone of apprehension…

The aim of comparative effectiveness research (CER) is to improve the quality, effectiveness, and efficiency of health care and to help patients, health care professionals, and purchasers make informed decisions. CER is moving forward, with recently defined priorities and a newly funded Patient-Centered Outcomes Research Institute, which we hope will survive congressional cost cutting.

Congressional cost cutting! How dare they! Those tea-party rubes! Anti-quality, that’s what they are!Continue reading “CER and MCC: a marriage made in DC”

On the Squandering of Medicare’s Money

Michel AccadJune 2, 2011June 8, 2017Healthcare economics, Healthcare policyLeave a comment

Emperor Joseph II: My dear young man, don’t take it too hard. Your work is ingenious. It’s quality work. And there are simply too many notes, that’s all. Just cut a few and it will be perfect.

Mozart: Which few did you have in mind, Majesty? (Amadeus, 1984)

The New York Times recently published an opinion editorial entitled “Squandering Medicare’s Money” in which Dr. Rita Redberg, professor of cardiology at UCSF, proposes that much of Medicare’s financial deficit could be reduced if the government did not spend “a fortune each year on procedures that have no proven benefit.” To support her contention, Redberg cites several studies which indicate that many routinely performed tests and treatments do not improve patient outcomes in any measurable way, and are therefore “unnecessary.” Examples given are screening colonoscopies for patients over 75, PAP smears for women over 65, coronary stents for people with stable angina, and so forth. At an estimated cost of $150 billion, these procedures seem like obvious candidates for the deficit-reduction chopping block.Continue reading “On the Squandering of Medicare’s Money”

Risk-Factor Medicine: An Industry Out of Control?

Michel AccadOctober 30, 2010December 13, 2016Medical science, Philosophy1 Comment

I co-wrote this editorial with Herb Fred. We outlined how the concept of risk factor, initially borrowed from the life insurance industry by the Framingham investigators, has spun out of control since the early 1960’s. Published in Cardiology, but unfortunately not free online (but reprints available upon request).

On Redefining Hypertension

Michel AccadJune 3, 2010December 13, 2016Medical scienceLeave a comment

An elevated blood pressure can be a normal physiologic reaction, an abnormality of uncertain significance, a marker of cardiovascular risk, or the cardinal sign of a disease with potentially serious immediate or long-term complications. Depending on the clinical circumstances, therefore, the physician can ignore the finding, extend the scope of observation, engage the patient in a conversation on statistical risk, or initiate antihypertensive therapy. Depending on the circumstances, therefore… Read full article @ PubMed Central.