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Gaining on death, cooling therapy catches on slowly

Rating

5 Star

Gaining on death, cooling therapy catches on slowly

Our Review Summary

This in-depth (3400 word) report on cooling patients after cardiac arrest in order to reduce the risk of brain damage offers readers a wealth of detail on therapeutic hypothermia, the available evidence of its effects, and some of the apparent reasons most hospitals have yet to put it into routine use. The story specifically notes the small numbers of patients that have been studied in controlled trials, as well as the fact that many patients would need to be treated in order for one additional person to recover fully. The story also makes a potent case that institutional and individual inertia and resistance to change has slowed the adoption of this technique despite recommendations from leading professional groups.

However, the only patient featured in the story is a man who fully recovered. The powerfully emotional telling of his cardiac arrest, his treatment, the strain on his family and their joy at his recovery may overwhelm the hard data indicating that while cooling does appear to offer benefits (and no greater risk of harm), the overwhelming majority of such patients will not recover despite receiving therapeutic hypothermia.

We couldn’t ask for a more comprehensive statement of the available facts, and yet it seems likely that most readers will come away from the story believing that cooling has more powerful effects than even its strongest advocates would claim.

 

Why This Matters

The likelihood of surviving and thriving after an out of hospital cardiac arrest has been low for a host of reasons.  As the story notes approximately 300,000 Americans suffer a heart attack outside the hospital with only a minority surviving and going back to their pre-event status.  Over the years, evidence has been mounting that cooling may improve both survival and brain function in cardiac arrest patients.  The balance of the data has now swung to the recommendation side.  Unfortunately, American medicine is notoriously slow to embrace recommendations by national and international organizations.  The reasons for this hesitancy are not clear.

 

The story highlights what has been a decade-long debate and an ongoing implementation challenge.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does a good job in articulating the expense associated with universal adoption of cooling methods including a calculation of cost per life saved and number needed to treat. The story notes that the calculations of costs are based on limited data and certain assumptions; nevertheless, some readers may still get the sense that the calculations are more precise than they actually are.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story does a generally careful job of pointing out that while the evidence indicates more cardiac arrest patients could benefit from cooling, many patients either don’t fit the profile and most of those that do still are unlikely to fully recover even if treated with cooling. The story describes the presumed benefits of cooling in both absolute and relative terms. At various points in the story in gives both percentages (which give a generous impression of the potential benefit), but also absolute numbers and the number of patient that would need to be treated in order to see at least one benefit (that give readers a more conservative impression.)

However, the personal story of a patient who recovered well may overwhelm the careful presentation of the statistics showing that the large majority of patients do not recover fully despite cooling, thus giving readers an inflated sense of the benefits of the technique.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story accurately reports that the trials done to date have not found that patients who underwent cooling had any higher rate of adverse effects than those who received standard care. However, as the Cochrane Collaboration review of the evidence noted, the studies have included a small number of patients and have not always used consistent or carefully controlled; therefore there may be a risk of adverse events that hasnot been documented.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story points out that the clinical trials of therapeutic hypothermia for people who have been resuscitated after cardiac arrest involve a total of only a few hundred patients. The story also refers to some of the conclusions of a systematic review of the evidence by the Cochrane Collaboration and a 2005 guideline statement from the American Heart Association that support the use of cooling in such cases.

However, the story does present an optimistic view of these reports.  For example, referring to the Cochrane review, the story suggests that, “…cooling increased the number of people with good brain function by more than half, and overall survival to hospital discharge by slightly more than one-third.”  The language suggests that these outcomes were actually seen in studies.  In reality these are projections based on the studies surveyed.  This is perhaps a subtle point but important because the number is based on a statistical inference and not on “real data.”

Readers are likely to get the sense that the evidence is conclusive, when actually there is still considerable uncertainty. The guideline of the American Heart Association rates the evidence supporting cooling for patients who had ventricular fibrillation as being Class IIa, meaning that while the weight of the evidence favors efficacy, “there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy.”

 

References:

 

Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation

Cochrane Collaboration 2010

http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD004128/frame.html

 

2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care

Part 7.5: Postresuscitation Support

http://circ.ahajournals.org/cgi/content/full/112/24_suppl/IV-84

Does the story commit disease-mongering?

Satisfactory

The story provides statistics related to out-of-hospital cardiac arrest and outcomes associated with standard as well as hypothermic resuscitation. The information is provided in an objective fashion.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quotes numerous sources including several with noted ties to the manufacturers of cooling devices.  Those with ties to industry are clearly identified in the story.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story does a reasonable job articulating the outcome differences seen with standard and hypothermic resuscitation and in providing information on expected outcomes with more widespread acceptance. It also notes that there are a variety of ways to cool the body and that while expensive devices are available that can rapidly cool the body from the outside or using intravenous saline, there is not yet enough evidence to conclude that one technique produces better outcomes than another.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story makes clear that most hospitals capable of treating cardiac arrest patients could apply therapeutic hypothermia using either simple techniques, such as ice bags, or sophisticated cooling systems. It also points out that many hospitals do not routinely use the technique. Comments from experts point to organizational roadblocks and resistance to change as the reason that therapeutic hypothermia is not used more often in appropriate cases.

Does the story establish the true novelty of the approach?

Satisfactory

The story points out that key clinical trials on this technique were published in 2002 and that it has been recommended by major professional groups since 2005. The heart of the story is about the barriers to adoption of a therapy that appears to be beneficial. It does not try to portray cooling as a new discovery.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not rely on a press release.  Numerous experts in the field are quoted and a summary of a well respected Cochrane Collaboration review as well as references to trials and guidelines are provided as background.

Total Score: 10 of 10 Satisfactory

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