Can you Understand your ICD Safety Alerts or Recalls?


Saw this today and thought would be good to share. Most educational materials are aimed at an 8th grade reading level, however this doesn’t hold true for pharmaceuticals and medical devices. Then to top it all off when patients hear about the problems and call their cardiologist, for the most part it seems to tick of the MD, because it takes up considerable amounts of their precious time to discuss. I brought up a recall alert once as a teaching opportunity, posted the notice, informed the clients to call their cardiologist and then got my rear end chewed off as the cardiology office didn’t want to have to deal with it. They eventually drafted a letter of their own and sent to all pacemaker/ICD patients to notify them.  What has been your experience?

Rochester and St Paul, MN - Those letters in which companies inform patients about “recalls” or “safety alerts” that involve their implanted pacemakers or defibrillators? They are written at such a complex level that they “may be incomprehensible for most patients,” according to researchers who rated the readability of such letters from one device company [1].

In 2006, the Heart Rhythm Society (HRS) recommended that device manufacturers communicate with patients affected by their safety advisories with a letter that should also be posted on the company’s website, observe Luke A Mueller (Mayo Clinic, Rochester, MN) and associates in their report published online January 2, 2013 Heart Rhythm.

But in their analysis of 25 such “Dear Patient” letters issued by Boston Scientific (including Guidant) from 2005 to 2011, their readability as measured by standard software was found to be at median grade level of 12.8, or college level in the US. Their reading levels were consistent over the six-year period.

None of the company letters, they note, met the National Working Group on Literacy and Health‘s recommendation of a fifth-grade level of readability for healthcare materials (p<0.001) or even the average US reading level corresponding to eighth grade (p<0.001). A sample letter devised by the HRS didn’t fare much better, coming in at a 12.5-grade level.

According to Mueller et al, who note that “patients affected by [implantable-device] advisories may experience psychological distress” and that poor communication can make that distress worse, “Device manufacturers should ensure advisory letters are comprehensible to most patients. Such letters may serve as a springboard for clinician discussions with patients of all reading skill levels about advisories and help the clinicians discern whether patients understand the clinical implications of the advisories affecting them and correct misinformation.”

Neither lead author Mueller nor coauthor Abigale L Ottenberg (Mayo Clinic) had disclosures. Coauthor Dr Arjun Sharma is the senior medical director at Boston Scientific. Senior author Dr Paul S Mueller (Mayo Clinic) is a member of the Boston Scientific Patient Safety Advisory Board.

Readability of “Dear Patient” device advisory notification letters created by a device manufacturer

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