Survey determines core outcome sets for actinic keratosis trials
The Delphi consensus determined that six core outcomes should be reported in regard to actinic keratosis trials, according to a survey study and review published in JAMA Dermatology.
The keywords “actinic keratosis” (AK) and “treatment” were searched in PubMed, Embase, CINAHL and the Cochrane Library to find English-language studies investigating treatments for AK published between 1980 and 2015. Patients with a history of AK were recruited from six dermatology clinics. International and U.S. physician stakeholders were recruited by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) steering committee based on whether the physician had been involved in core outcome set (COS) development and/or expertise with AK.
The stakeholders participated in the eDelphi process and rated the importance of each outcome in the survey on a scale of 1 to 9 as not important (1 to 3), important but not critical (4 to 6) and critically important (7 to 9).
“Outcomes were considered for inclusion in the final core set if at least 70% of physician or patient stakeholders rated them as critically important and the mean score in either stakeholder group was 7.5 or higher,” Kelly A. Reynolds, BA, of the University of Cincinnati College of Medicine, and colleagues wrote.
In total, 137 unique outcomes were included in the eDelphi surveys. For the first round, 12 patients and 21 physicians participated, and all patients and 17 physicians (81%) completed the second round.
The final COS included the following outcomes: completed clearance of AKs, treatment percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference and recurrence rates.
“This study establishes what should be measured in AK trials,” the researchers wrote. “Next steps for research include the development of a set of core outcome measures to further standardize how these outcomes should be addressed.”
This is an important study that identified a set of outcomes that were not only highly valuable, but also feasible in trials that investigate safety and efficacy of interventions for AK, Aditya K. Gupta, MD, PhD, of the division of dermatology in the department of medicine at the University of Toronto, and colleagues wrote in an accompanying editorial.
“The proposed set of core outcomes by Reynolds et al is a great start in standardizing outcomes guidelines for trials on actinic keratosis interventions,” Gupta and colleagues wrote. – by Erin T. Welsh
Disclosure s : Reynolds and the editorial authors report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.