Development of a Core Outcome Domain Set for Facial Aging.

IF 10.9 1区医学 Q1 DERMATOLOGY

JAMA dermatology Pub Date : 2026-08-01 DOI:10.1001/jamadermatol.2026.1697

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

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引用次数: 0

Abstract

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.

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面部老化的核心结果域集的开发。

重要性：目前，在面部衰老的临床试验中没有标准化的结果域或测量方法。临床试验结果域和测量工具的异质性给直接比较干预措施、确定更好的治疗方法和开展高质量的荟萃分析带来困难。目的：建立一个核心结果集（COS），用于评估面部衰老干预措施的临床试验。证据回顾：检索自2005年9月至2015年9月的PubMed/Medline、Embase、Cochrane Central Register of Controlled Trials和CINAHL。从2015年9月到2026年2月对同一数据库进行了更新搜索。如果研究包括：(1)他们是随机临床试验或对照临床试验设计，(2)他们评估了干预面部衰老的有效性或安全性，(3)他们用英文发表，(4)他们涉及人类参与者。补充来源，包括患者访谈，用于获取进一步的相关结果。两轮德尔菲调查，随后是共识会议，用于确定患者和医生利益相关者认为最重要的结果领域。结果：最终COS由6个结果域组成：(1)总体治疗便利性；（二）恢复正常工作和社会活动的时间；(3)对治疗重点区域的总体评估（在治疗预计提供最大效益的时间点）；(4)治疗效果持续时间；(5)持续的局部或全身不良事件的严重程度，包括色素改变、皮肤质地改变、延迟愈合、瘢痕形成和严重不良事件；(6)患者对治疗的满意度。结论和相关性：通过德尔菲共识确定的6个结果域被推荐用于未来面部衰老试验的报告，以确保对患者和临床医生最重要的结果被测量，并且结果在干预措施中具有可比性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JAMA dermatology DERMATOLOGY-

CiteScore

14.10

自引率

5.50%

发文量

300

期刊介绍： JAMA Dermatology is an international peer-reviewed journal that has been in continuous publication since 1882. It began publication by the American Medical Association in 1920 as Archives of Dermatology and Syphilology. The journal publishes material that helps in the development and testing of the effectiveness of diagnosis and treatment in medical and surgical dermatology, pediatric and geriatric dermatology, and oncologic and aesthetic dermatologic surgery. JAMA Dermatology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. It is published online weekly, every Wednesday, and in 12 print/online issues a year. The mission of the journal is to elevate the art and science of health and diseases of skin, hair, nails, and mucous membranes, and their treatment, with the aim of enabling dermatologists to deliver evidence-based, high-value medical and surgical dermatologic care. The journal publishes a broad range of innovative studies and trials that shift research and clinical practice paradigms, expand the understanding of the burden of dermatologic diseases and key outcomes, improve the practice of dermatology, and ensure equitable care to all patients. It also features research and opinion examining ethical, moral, socioeconomic, educational, and political issues relevant to dermatologists, aiming to enable ongoing improvement to the workforce, scope of practice, and the training of future dermatologists. JAMA Dermatology aims to be a leader in developing initiatives to improve diversity, equity, and inclusion within the specialty and within dermatology medical publishing.