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Development of a Core Outcome Domain Set for Facial Aging.

Researchers

McKenzie A Dirr, Areeba Ahmed, Daniel I Schlessinger, Vanessa Lazaro-Camp, Sabrina Smith, Thanvi Gullapalli, Doroteja Dragovic, Joycie Chang, Elizabeth Zhang, Murad Alam, Noor Anvery, Rachel E Christensen, Sarah A Ibrahim, Bianca Y Kang, Clarissa Wong, Sanjana Iyengar, Arianna F Yanes, Jill Cotseones, Hovik J Ashchyan, Payal M Patel, Umar A Sheikh, Matthew J Franklin, Courtney C Hanna, Sarah G Chiren, Jochen Schmitt, Karina C Furlan, Macrene Alexiades, Raed Alhusayen, Tina S Alster, Kenneth Beer, Vince Bertucci, Jason D Bloom, César A Briceño, Vivian Bucay, Kimberly J Butterwick, Cartier Hugues, Gabriela Casabona, Karen L Connolly, Sebastian Cotofana, Martha Laurin Council, Sue Ellen Cox, Monica Darmanescu, Koenraad De Boulle, Shraddha Desai, Lisa M Donofrio, Jeffrey S Dover, Zoe Draelos, Daniel B Eisen, Moetaz El-Domyati, Yehia El-Garem, John Fischer, Rebecca Fitzgerald, Daniel P Friedmann, Hassan Galadari, Hayes B Gladstone, Mitchel P Goldman, Greg J Goodman, Jeremy B Green, Shlomit Halachmi, C William Hanke, Shannon Humphrey, Sherrif F Ibrahim, Jared Jagdeo, Shang I Brian Jiang, Julie K Karen, Arielle Kauvar, Abdul-Ghani Kibbi, John V S Kim, Jenny Kim, Davi de Lacerda, Gary Lask, Grace M Lopez, Mary P Lupo, Kavita Mariwalla, Seth Matarasso, Lally Mekokishvili, Rhoda S Narins, Patricia Ogilvie, Jeffrey S Orringer, Tammy H Osaki, David Ozog, Theresa Pacheco, Kristel Polder, Anthony M Rossi, Neil Sadick, Nazanin Saedi, Joel Schlessinger, Jaishree Sharad, Manjunath M Shenoy, Rodney Sinclair, Nowell Solish, Miriam Emily Piansay-Soriano, Omotara Sulyman, Rolf-Markus Szeimies, Elizabeth L Tanzi, Amy Forman Taub, Mark B Taylor, J Regan Thomas, Luis Torezan, Antonella Tosti, Dany Touma, Ada Regina Trindade de Almeida, Maya Vedamurthy, Giovanni Viana, Abigail Waldman, Susan H Weinkle, Robert Weiss, Emily Poon, Ian A Maher, Todd V Cartee, Joseph F Sobanko, Jamie J Kirkham

Abstract

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. To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. 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. 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. 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.
Source: PubMed (PMID: 42307924)View Original on PubMed