Why Johnny can't read (his ICD safety-advisory letter)

January 05, 2013

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.

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