ESTABLISHING THRESHOLDS FOR CLINICAL SIGNIFICANCE WITH A PHYSICIAN DELPHI PANEL
Author(s)
Merikle E1, McClure E2, Yu TC3, Smiell JM3, Boing E4
1Covance Market Access, Inc., Gaithersburg, MD, USA, 2Covance Market Access, Gaithersburg, MD, USA, 3Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA, 4Mallinckrodt Pharmaceuticals, Lawrenceville, GA, USA
OBJECTIVES Reducing the amount of harvested donor skin (HDS; autograft) needed for definitive wound closure can improve outcomes in patients with severe burns. Consensus for what constitutes a clinically significant reduction in the amount of HDS is not available. Our objective was to convene a Delphi Consensus Panel (DCP) to determine the threshold of clinical significance for reduction in the amount of HDS to achieve definitive closure in deep-partial-thickness (DPT) and full-thickness (FT) burns. METHODS A two-round DCP (defined a priori as > 70% panelist agreement) was conducted among 15 burn physicians with at least three years of post-residency experience and total career experience of caring for ≥ 500 patients. Round 1 consisted primarily of open-ended questions about clinical decision making and treatment practices for DPT and FT. Round 2 required evaluation of treatment scenarios to gain consensus regarding thresholds for clinical significance for the reduction in amount of HDS for treatment of DPT and FT burns. RESULTS Fourteen (93.3%) panelists completed both rounds. In Round 1, most panelists reported that reduction of HDS was important for both DPT (n=10; 66.7%) and FT (n=9; 60.0%) burns with the percent total body surface area (%TBSA) being the most important factor in clinical decisions. The most important outcomes after definitive closure were scar quality/cosmesis and functioning. In Round 2, consensus was achieved in a meaningful reduction in the amount of HDS in improving patient outcomes (n=14; 100%). Consensus was also achieved for a threshold for clinical significance for reduction in HDS: 50% reduction for DPT [20 %TBSA] and FT [10 %TBSA] burns (n=13; 92.9% and n=12; 85.7%, respectively) and 35% reduction for mixed DPT and FT burns [45 %TBSA] (n=14; 100%). CONCLUSIONS Thresholds for clinical significance of HDS reduction in DPT and FT burns were established via the DCP.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PIT1
Topic
Clinical Outcomes, Health Service Delivery & Process of Care, Methodological & Statistical Research
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes, Survey Methods, Treatment Patterns and Guidelines
Disease
Injury and Trauma