PICO P = women I = diabetes C = no diabetes O = moderate to severe hearing loss
Are the results of this harm study valid Were there clearly defined groups of patients, similar in all important ways other than exposure to the treatment or other cause? Probably yes, subjects were women recruited from Nurses’ Health Studies (NHS) I and II cohort studies which were followed with biennial questionnaires Analysis were limited to those who provided information on their hearing
Are the results of this harm study valid Were the treatment exposures and clinical outcomes measured in the same ways in both groups (e.g., was the assessment of outcomes either objective (e.g., death) or blinded to exposure? Yes, ascertainment of type 2 diabetes, diabetes duration, and hearing loss (Methods, p.2/5)
Are the results of this harm study valid Was the follow-up of study patients complete and long enough Yes, 28 years (1984 to 2012) in NHS 1 and 14-18 years (1995 to 2009 and/or 2013) in NHS II (Methods, p.2/5)
Are the results of this harm study valid Do the results satisfy some “diagnostic test for causation”? Is it clear that the exposure preceded the onset of outcome? Yes, women who reported a hearing problem that started before baseline in the NHS I (1984) and NHS II (1995 ) were excluded Is there a dose-response gradient? Yes, the longer the duration the higher risk in those who had type 2 diabetes (Discussions, p.5/5) Is there positive evidence from a dechallenge – rechallenge study? No
Are the results of this harm study valid Do the results satisfy some “diagnostic test for causation” Is the association consistent from study to study? No, Findings from the few studies investigating the association between the duration of type 2 diabetes and hearing loss have been inconsistent (Discussions, p.5/5) Does the association make biological sense? Yes, similar mechanisms with obesity, including oxidative stress and other pathways of diabetes-related hearing loss which showed atrophy of the spiral ganglion and demyelination of the auditory nerve (Discussions, p.5/5)
Should these valid, potentially important results change the treatment of your patient? Can the results be extrapolated to your patient? Yes, to patients with the same characteristics What are your patients’s risks of the adverse outcome?
Should these valid, potentially important results change the treatment of your patient? What are your patient’s preferences, concerns and expectations from this treatment? Not relevant What alternative treatments are available? Not relevant