痤疮瘢痕：临床试验核心结局集的制定方案。

Acne scarring: protocol for development of a core outcome set for clinical trials.

作者信息

Haq Misha, Koza Eric, Ma Melissa S, Ahmed Areeba, Shi Victoria J, Cahn Brian, Kirkham Jamie J, Maher Ian A, Sobanko Joseph F, Cartee Todd V, Alam Murad

机构信息

Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Department of Dermatology, University of Illinois Chicago, Chicago, Illinois, USA.

出版信息

BMJ Open. 2025 Apr 29;15(4):e088049. doi: 10.1136/bmjopen-2024-088049.

DOI:10.1136/bmjopen-2024-088049

PMID:40306913

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12049930/

Abstract

INTRODUCTION

Acne scarring is one of the primary sequelae that affect patients with acne, with facial scarring occurring to some extent in 95% of patients with active acne. Subtypes include atrophic, hypertrophic and keloid scarring. Treatment options include topical and surgical approaches. Despite numerous clinical trials focusing on acne scarring treatments, the absence of standardised outcome reporting across these trials raises concerns in evaluating treatment methods. To address this issue, this project aims to develop a core set of outcomes which should be uniformly assessed in all clinical trials involving acne scarring.

METHODS AND ANALYSIS

Outcomes will be extracted from four sources: a systematic literature review, patient interviews, printed and electronic sources and stakeholder involvement. The steering committee will assess the potential outcomes, adding or removing outcomes if needed. The Delphi process will be performed to understand the importance of outcomes. Two rounds of Delphi surveys will be completed by physicians, researchers and patients. Following this, a consensus meeting involving stakeholders will be held to refine the outcomes based on participant scores. The meeting will end in a voting process to determine a final recommended core outcome set (COS). This study will be conducted in collaboration with the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the CHORD COUSIN Collaboration (C3). This study aims to develop a global COS to standardise assessment approaches in clinical trials of acne scarring. The final goal is to enhance uniformity of outcome reporting.

ETHICS AND DISSEMINATION

Ethical approval and consent to participate for the study have been granted by Northwestern University Institutional Review Board protocol ID: STU00097285. On completion of the COS, we plan to publish our results in peer-reviewed journals and send participants the finalised COS.

PROSPERO REGISTRATION DETAILS

This study is registered with PROSPERO (CRD42023460964), COMET (754) and C3 (https://www.c3outcomes.org/improved-acne-scarring).

摘要

引言

痤疮瘢痕是影响痤疮患者的主要后遗症之一，95%的活动性痤疮患者面部会出现一定程度的瘢痕。亚型包括萎缩性、增生性和瘢痕疙瘩性瘢痕。治疗选择包括局部和手术方法。尽管有许多临床试验聚焦于痤疮瘢痕治疗，但这些试验缺乏标准化的结果报告，这在评估治疗方法时引发了担忧。为解决这一问题，本项目旨在制定一套核心结局指标，在所有涉及痤疮瘢痕的临床试验中应统一进行评估。

方法与分析

结局指标将从四个来源提取：系统文献综述、患者访谈、印刷和电子资料以及利益相关者参与。指导委员会将评估潜在的结局指标，必要时进行增减。将进行德尔菲法以了解结局指标的重要性。医生、研究人员和患者将完成两轮德尔菲调查。在此之后，将举行一次利益相关者共识会议，根据参与者的评分完善结局指标。会议将以投票过程结束，以确定最终推荐的核心结局指标集（COS）。本研究将与有效性试验核心结局指标（COMET）倡议和CHORD COUSIN合作项目（C3）合作开展。本研究旨在制定一个全球COS，以规范痤疮瘢痕临床试验中的评估方法。最终目标是提高结局报告的一致性。