Cartee, Todd V.

Importance Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.

BACKGROUND Success in skin cancer treatment is determined through outcome measurement. Patients and physicians may prioritize different outcomes of care, and identification of such may enhance patient-centered care. OBJECTIVE To identify gaps between patient and physician attitudes toward skin cancer outcomes. MATERIALS AND METHODS A single-day, 21-patient, modified, in-person Delphi process to solicit and rate the importance of skin cancer–related outcomes was conducted. Twelve masked dermatologic surgeons rated patient-generated outcomes in a 2-round modified Delphi process. Each item was rated on a 1 to 9 scale (1, least important; 9, most important) using the Qualtrics web platform (Qualtrics, Provo, UT). Results of the physician ratings were compared with the patient ratings. RESULTS A list of 53 skin cancer treatment–related themes and outcomes was generated. Eight items were ranked by physicians as “very high” (>80% importance), 5 as “high” (>70% importance), 19 as intermediate, and 21 as low. The physician and patient panels' ratings were concordant for 56% of items, whereas 7 outcome items showed a 2-category discordance. CONCLUSION Physicians and patients were concordant regarding skin cancer treatment on multiple spheres. Areas of discordance include patient fear of unknown future risk, recurrence, or empowering patients to make treatment choices, and may be areas of continued improvement for delivery of patient-centered care.

BACKGROUND Patient-reported outcomes are critical to research directed at maximizing patient benefit. The outcomes patients consider most relevant in the treatment of skin cancer have not been directly investigated. OBJECTIVE To develop a ranked list of outcomes deemed most important by patients with skin cancer through a proctored Delphi process. METHODS Twenty-one patients with a history of skin cancer volunteered to participate in the patient summit. The patient members participated in a guided discussion to generate a long list of potentially relevant outcomes. The list was then condensed and ranked through 2 rounds of a proctored Delphi process. RESULTS Patients were diverse in their skin cancer histories and complexities, ages, and states of residence. Twelve themes were rated as highly important by 70% or more of participants. Most of these themes related to patient education and the collaborative nature of the physician–patient relationship. Fear of recurrence and cosmetic outcome were also highly rated. Limitations include a preponderance of older patients and patients from the midwest and northeast. CONCLUSION Patients with skin cancer overwhelmingly prioritize a shared decision-making process, in which they are actively engaged and value detailed education regarding their disease. This should inform future research directed at skin cancer treatment and current physician–patient interactions.

e21079 Background: Increased emphasis is being placed on patient centered outcomes. There is little existing literature on the patient population's prioritization of outcomes in skin cancer care. A PCORI-supported Patient Outcomes Summit was organized to address this. Methods: Patients were recruited from patient support groups, solicitation of ASDS member practices, as well as personal recruitment of patients from the practices of the investigators. A one-day Patient Outcome Summit was convened in Arlington, VA in August 2016. Patients attendees were given orientation to existing outcomes for skin cancer as well as the Delphi process. They then participated in a two round Delphi process by run non-physician facilitators (AB and EA). Group discussion was used to solicit outcomes for inclusion in the rating rounds. Outcomes were then rated anonymously on a 1 (lowest relevance) to 9 (highest relevance) scale. Patients were then able to view the anonymous feedback of the group and rerate the items as they deemed fit based on the group feedback. Results: 21 patients participated in the Delphi process (5 men and 21 women). 10 were melanoma and 11 were non-melanoma patients. 56 treatment related outcomes and themes were identified. The ten most highly rated themes are shown in the table. Conclusions: The first ever skin cancer patient outcome summit was convened to address the lack of patient-centered data in the skin cancer literature and guide measure development. Some traditional outcomes (recurrence) were identifiend. However, the majority of the themes rated most important by the patient attendees center around inclusion of the patient in the decision making process and the physician-patient communication. Increased emphasis and education in these domains may drive increased patient satisfaction in skin cancer care. [Table: see text]