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Correction to Plaisance et al., N Engl J Med 341(8):569-575 August 19, 1999.

Correspondence
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Volume 341:1770-1772 December 2, 1999 Number 23
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Active Compression–Decompression Cardiopulmonary Resuscitation

 

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To the Editor: As an investigator in four initial studies of active compression–decompression cardiopulmonary resuscitation (CPR), including a large randomized trial,1 I would like to comment on the report by Plaisance et al. (Aug. 19 issue).2 All studies of active compression–decompression CPR are seriously flawed by their complete lack of blinding. My own experience with the active compression–decompression device has demonstrated its powerful effect on participants' efforts. Imagine the additional effect when an unblinded intervention is not a pharmacologic or electrical therapy, but a mechanical device, the efficacy of which depends on the vigor and technique of its use.

Additional opportunities for error arise when, as in the study by Plaisance et al., unblinded investigators both supervise the use of the device and directly manage the resuscitation that determines its success. If the chance of survival increases, the quality of neurologic outcome becomes crucial, but scoring is reliable only when blinded investigators with proved interrater reliability directly examine patients with use of validated instruments.3 In the study by Plaisance et al., subjective outcomes were obtained from third parties (proved unreliable in previous research) by unblinded investigators, and the reproducibility of ratings was not tested.

The sophisticated, intensive resuscitation resources of the Service d'Aide Médicale Urgente are the diametric opposite of most of the world's emergency medical services. In the current study, 25 percent of one-year survivors had an arrest that was witnessed by advanced-life-support personnel (and apparently another 25 percent had an arrest that was witnessed by basic-life-support personnel). These are small, atypical subpopulations, different from those with the citizen-witnessed arrests studied in most CPR research, and should be analyzed separately in the Utstein model.

I admire the investigators' hard work, but it is well known that we researchers (like all humans) are strongly motivated to find better treatments. The less rigorous a study's methods, the greater the likelihood that it will yield positive results.4 Even when investigators are blinded, failure to implement blinding as rigorously as possible increases the odds of a positive result by 40 percent.5 There were so many opportunities for positive-outcome bias in this investigation (and previous investigations) of active compression–decompression CPR that it would be surprising statistically if some studies did not report efficacy.


Michael Callaham, M.D.
University of California San Francisco
San Francisco, CA 94143-0208

References

  1. Schwab TM, Callaham ML, Madsen CD, Utecht TA. A randomized clinical trial of active compression-decompression CPR vs standard CPR in out-of-hospital cardiac arrest in two cities. JAMA 1995;273:1261-1268. [Free Full Text]
  2. Plaisance P, Lurie KG, Vicaut E, et al. A comparison of standard cardiopulmonary resuscitation and active compression-decompression resuscitation for out-of-hospital cardiac arrest. N Engl J Med 1999;341:569-575. [Free Full Text]
  3. Hsu JW, Madsen CD, Callaham ML. Quality-of-life and formal functional testing of survivors of out-of-hospital cardiac arrest correlates poorly with traditional neurologic outcome scales. Ann Emerg Med 1996;28:597-605. [CrossRef][Medline]
  4. Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998;352:609-613. [CrossRef][Medline]
  5. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-412. [Free Full Text]

 
To the Editor: In the study by Plaisance et al. on the use of active compression–decompression resuscitation in France, approximately 10 percent of witnessed arrests involved CPR by a bystander. The importance of this observation is diminished by the authors' statement, "The use of CPR by a bystander was not found to affect one-year survival in this study." However, this statement is confusing, since Table 3 of their article implies that for 14 of the 24 long-term survivors, CPR was performed by a bystander. Since 14 of the 57 who received bystander-initiated CPR survived, as compared with only 10 survivors among the other 693, this difference corresponds to an odds ratio of 22 in favor of bystander-initiated CPR. Recognizing that other factors may be pertinent (for instance, bystanders providing CPR may be more familiar with available emergency medical resources, resulting in earlier introduction of advanced-life-support protocols), this odds ratio makes the benefits of active compression–decompression resuscitation (odds ratio for survival, 2.5) seem minor in comparison and suggests that efforts to increase the extremely low rate of bystander-initiated CPR are well justified.


Michael R. Bubb, M.D.
University of Florida
Gainesville, FL 32610


 
To the Editor: Plaisance et al. report the results of a randomized trial that showed improved survival with the use of active compression–decompression resuscitation as opposed to conventional heart massage for persons with out-of-hospital cardiac arrest. I am surprised that allocation of the experimental treatment on alternate days (odd days) continues to be accepted by authoritative journals as randomized — that is, without any pattern.

Moreover, and more important, their conclusion is based on an increase in long-term survival by a factor of less than three (5 percent, vs. 2 percent with standard CPR) in a population with cardiac arrest with a remarkably high incidence of asystole as the first monitored rhythm. Five years ago, a doubling of the rate of good outcomes as a result of external pacing in a smaller but similar population was not considered a result substantial enough to alter current guidelines.1 The obvious question — whether emergency medical systems that have already achieved far better outcomes without the active compression–decompression device than the French emergency medical system have achieved with it, should nevertheless adopt this technique — remains unanswered.


Patrick Martens, M.D.
Sint Jan Hospital
8000 Brugge, Belgium

References

  1. Martens P. Equal judging of new treatments in resuscitative medicine. Resuscitation 1994;27:261-262. [Medline]

 
Dr. Plaisance replies:

To the Editor: Dr. Callaham is aware of the hemodynamic data from studies in animals and in humans in support of active compression–decompression CPR. Unlike his prehospital field experience, in which use of the gauge was not emphasized and the device was not widely used before its efficacy was evaluated, we had the benefit in Paris of knowing with a high degree of certainty that active compression–decompression was being performed correctly, since it had been introduced into the Paris emergency medical system two years before the study began. Although the limitations of performing a new technique in an unblinded manner are important, issues related to proper training, use of the gauge, and widespread implementation of a technique before it is compared with the widely accepted standard are most likely more important. There are probably many opportunities for positive-outcome bias in research, but there are also opportunities for negative-outcome bias, as stated by Nolan et al.1 Finally, the survivors in the standard-CPR group, not the active compression–decompression group, had a very high percentage of arrests witnessed by advanced-life-support personnel.

As noted by Dr. Bubb, few patients in Paris receive CPR from a bystander. This is an unfortunate situation but may slowly be improving, as noted in the conclusion of our article. Nonetheless, the standard-CPR group and the active compression–decompression group were similar with regard to the number of patients who received bystander CPR, but the outcomes were clearly better in the active compression–decompression group.

In response to Dr. Martens: we did not randomize by patient number because of the logistic problem that would be involved in trying to coordinate all the rescue units at any point in time. Our low randomization errors support our approach.

In view of a meaningful improvement in outcome when this technique is performed by well-trained personnel, we continue to support, as do other investigators,2,3,4 more widespread use of this technique.


Patrick Plaisance, M.D.
Lariboisière University Hospital
75475 Paris, France

Editor's note: The following disclosure statement was omitted from the article entitled "A Comparison of Standard Cardiopulmonary Resuscitation and Active Compression–Decompression Resuscitation for Out-of-Hospital Cardiac Arrest," by Plaisance et al. "Dr. Lurie is a co-inventor of the CardioPump, the device used to perform active compression–decompression cardiopulmonary resuscitation, and is entitled to potential royalties from the sale of the device." We regret the omission.

References

  1. Nolan J, Smith G, Evans R, et al. The United Kingdom pre-hospital study of active compression-decompression resuscitation. Resuscitation 1998;37:119-125. [CrossRef][Medline]
  2. Gueugniaud P-Y, Mols P, Goldstein P, et al. A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. N Engl J Med 1998;339:1595-1601. [Free Full Text]
  3. Lurie KG, Shultz JJ, Callaham ML, et al. Evaluation of active compression-decompression CPR in victims of out-of-hospital cardiac arrest. JAMA 1994;271:1405-1411. [Free Full Text]
  4. Lefrançois D. Prehospital use of ACD-CPR in a EMT-D level EMS system. Resuscitation 1998;37:S31-S31.abstract 

 


 

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