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Specific guide to this web site for:

 1.  Medical School
      Educators 
      in Statistics

 2.  Medical Students

 3.  Science media writers

 4.  High School & College
     Statistic Teachers

   Misadventures:

1. Harvard led MI study

2. JACC study 
   (J. of Amer. Coll.
   Cardio.)

3. NEJM cath study

4. Amer. J. of Cardio.
    review of literature

5. ALLHAT
    controversy 

6. Oat bran study

7. Pregnancy & Alcohol

8. Are Geminis really
    different?
      
9. Columbia 'Miracle' Study  
                                                 

Additional Topics:

Celebrex

Limitations of Meta-Analyses

Large Randomized Clinical Trials

Tale of Two Large
Trials

Advocate meta-analyses

Network meta-analyses

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Details of the study:

This study concerned cardiac patients undergoing outpatient cardiac catheterization¹.  In this study there were 192 outpatients, and 189 inpatients. There were three heart attacks in the outpatient group, and one heart attack in the inpatient group.  The authors conclude that heart catheterization is safe to perform as an outpatient.

The conclusions of this study were the opposite of what the troubling data suggested.  This study is a primer on how to ignore trends in data, use an inadequate sample size, and miscount data points, all in a major medical journal. 

Elective heart catheterization in stable patients is usually associated with a major complication (stroke, MI. or death) in only 1 out of 1000 patients². This study reported that 3 patients out of 192 patients (approximately 1 out of 64) of outpatients experienced an MI with elective outpatient cardiac catheterization and that 1 patient out of 189 patients with inpatient cardiac catheterization had an MI.

Implausibly, the authors concluded that these patient results demonstrated that outpatient heart catheterization is safe. Outpatient catheterization actually is safe, but the data in this study suggests the opposite.  (The authors did note that because of the small sample size they could not exclude a small increase in complication rates. Nevertheless, their data did not suggest outpatient catheterization was safe. As it turned out, the seemingly high complication rate with outpatient catheterization in this study was a result of the authors miscounting data points as well as not following their own trial protocol.) 

In contrast, if a heart catheterization laboratory was actually found to have 1 out of 65 patients of the last 190 stable patients undergoing low risk diagnostic heart catheterization develop a heart attack, that program would need to intensely investigate if a significant procedural problem exists.

The authors subsequently reveal in a follow-up letter³ they had mistakenly counted patients having a heart attack twice rather than once. This occurred even though having a heart attack as a complication of the procedure was the most important primary trial data endpoint and they only counted a total of 4 heart attacks.  Furthermore, contrary to their descriptions of the patients as being low risk outpatient cardiac catheterization, they accidentally included at least one patient in the outpatient group that had a much higher risk procedure, elective balloon angioplasty who went on to have a heart attack.  This was a clear and unacceptable violation of their description of the patients being studied in their trial.

Hence, in this one study the authors not only misinterpreted their data and ignored adverse trends, they miscounted their data endpoints and unintentionally broke trial protocol as well.

1.  Block P, Ockene I, Goldberg R, et al. A Prospective Randomized Trial of Outpatient versus Inpatient Cardiac Catheterization; N Engl J Med 1988: 219: 1251-55.

2. Davis K, Kennedy J,Kemp J, et al. Complications of Coronary Arteriography from the Collaborative Study of Coronary Artery Surgery (CASS). Circulation 1979: 59: 1105-12.

3.  Letter. Outpatient versus inpatient catheterization; Block P. NEJM 1989; 320:938-939