颈阔肌突出的患者报告结果测量的发展和验证。

IF 2.2 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Current Medical Research and Opinion Pub Date : 2025-07-01 Epub Date: 2025-07-31 DOI:10.1080/03007995.2025.2537898
Julia K Garcia, Rene M Hopfinger, Catherine Foley, Julie Whyte, Martha Gauthier, Brandon Foster, Vaishali Patel
{"title":"颈阔肌突出的患者报告结果测量的发展和验证。","authors":"Julia K Garcia, Rene M Hopfinger, Catherine Foley, Julie Whyte, Martha Gauthier, Brandon Foster, Vaishali Patel","doi":"10.1080/03007995.2025.2537898","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Platysma prominence (PP) is characterized by vertical bands along the length of the neck and blunting of the jawline, impacting aesthetic appearance. No validated patient-reported outcome (PRO) measures are available to assess patient experiences specific to PP.</p><p><strong>Objective: </strong>Develop and validate fit-for-purpose PRO measures that capture patient experiences with PP and treatment outcomes.</p><p><strong>Methods: </strong>PRO measures were developed and validated in alignment with the FDA's patient-focused drug development guidance. Three interviews (concept elicitation [CE], <i>N</i> = 30; cognitive debriefing [CD] round 1, <i>N</i> = 20; round 2, <i>N</i> = 5) were conducted with treatment-naive and previously treated adults with PP. Instruments were drafted based on concepts emerging from CE interviews. Psychometric testing for reliability and validity was conducted using phase 2 PP treatment study (ClinicalTrials.gov; NCT03915067) data (<i>N</i> = 164). While there were no available gold standard measures, convergent and known-groups validity were assessed using multiple FACE-Q modules, the Participant Global Impression of Severity (PGIS)-Jawline, and the Participant Global Impression of Treatment Satisfaction (PGI-TS). The 2-way random intraclass correlation coefficient ICC(2,1) and R<sub>λ</sub> were calculated to evaluate test-retest reliability. Values of ≥0.70 were considered success for both the ICC(2,1) and R<sub>λ</sub>. Spearman correlations (ρ) between scores from draft instruments and co-validators were used to assess convergent validity (|ρ|≥0.40). Additionally, internal consistency reliability was examined for multi-item measures where Cronbach's α ≥ 0.70 was considered success.</p><p><strong>Results: </strong>\"Bands\" or a variation (e.g., cords, ridges, lines) were the most common terms used to describe PP, reported by 50% of participants. The most frequently reported psychosocial impacts were looking older than desired (<i>n</i> = 28, 93.3%), feeling self-conscious (<i>n</i> = 24, 80.0%), feeling less attractive (<i>n</i> = 20, 66.7%), and looking less attractive and dressing differently (both: <i>n</i> = 19, 63.3%). Reduced platysma band prominence was the most cited change that would increase satisfaction (<i>n</i> = 15, 50.0%). Following CE interviews, 3 PRO measures were drafted: Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, ANLFQ: Satisfaction (Baseline/Follow-up), and the Bother Assessment Scale-Platysma Prominence (BAS-PP). CD interviews indicated that participants found the questionnaires understandable and relevant. In psychometric testing, established criteria for reliability and validity were predominantly met, with some exceptions. Three correlations were under the 0.40 threshold, and while these correlations were all in the expected direction, their smaller magnitudes were not unexpected given the restricted conceptual alignment between the PP PROs and co-validating measures.</p><p><strong>Conclusion: </strong>These PRO measures demonstrated content and psychometric validity and are ready for use in research and practice to better understand the impact of PP from the patient perspective.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1277-1290"},"PeriodicalIF":2.2000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and validation of patient-reported outcome measures for platysma prominence.\",\"authors\":\"Julia K Garcia, Rene M Hopfinger, Catherine Foley, Julie Whyte, Martha Gauthier, Brandon Foster, Vaishali Patel\",\"doi\":\"10.1080/03007995.2025.2537898\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Platysma prominence (PP) is characterized by vertical bands along the length of the neck and blunting of the jawline, impacting aesthetic appearance. No validated patient-reported outcome (PRO) measures are available to assess patient experiences specific to PP.</p><p><strong>Objective: </strong>Develop and validate fit-for-purpose PRO measures that capture patient experiences with PP and treatment outcomes.</p><p><strong>Methods: </strong>PRO measures were developed and validated in alignment with the FDA's patient-focused drug development guidance. Three interviews (concept elicitation [CE], <i>N</i> = 30; cognitive debriefing [CD] round 1, <i>N</i> = 20; round 2, <i>N</i> = 5) were conducted with treatment-naive and previously treated adults with PP. Instruments were drafted based on concepts emerging from CE interviews. Psychometric testing for reliability and validity was conducted using phase 2 PP treatment study (ClinicalTrials.gov; NCT03915067) data (<i>N</i> = 164). While there were no available gold standard measures, convergent and known-groups validity were assessed using multiple FACE-Q modules, the Participant Global Impression of Severity (PGIS)-Jawline, and the Participant Global Impression of Treatment Satisfaction (PGI-TS). The 2-way random intraclass correlation coefficient ICC(2,1) and R<sub>λ</sub> were calculated to evaluate test-retest reliability. Values of ≥0.70 were considered success for both the ICC(2,1) and R<sub>λ</sub>. Spearman correlations (ρ) between scores from draft instruments and co-validators were used to assess convergent validity (|ρ|≥0.40). Additionally, internal consistency reliability was examined for multi-item measures where Cronbach's α ≥ 0.70 was considered success.</p><p><strong>Results: </strong>\\\"Bands\\\" or a variation (e.g., cords, ridges, lines) were the most common terms used to describe PP, reported by 50% of participants. The most frequently reported psychosocial impacts were looking older than desired (<i>n</i> = 28, 93.3%), feeling self-conscious (<i>n</i> = 24, 80.0%), feeling less attractive (<i>n</i> = 20, 66.7%), and looking less attractive and dressing differently (both: <i>n</i> = 19, 63.3%). Reduced platysma band prominence was the most cited change that would increase satisfaction (<i>n</i> = 15, 50.0%). Following CE interviews, 3 PRO measures were drafted: Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, ANLFQ: Satisfaction (Baseline/Follow-up), and the Bother Assessment Scale-Platysma Prominence (BAS-PP). CD interviews indicated that participants found the questionnaires understandable and relevant. In psychometric testing, established criteria for reliability and validity were predominantly met, with some exceptions. Three correlations were under the 0.40 threshold, and while these correlations were all in the expected direction, their smaller magnitudes were not unexpected given the restricted conceptual alignment between the PP PROs and co-validating measures.</p><p><strong>Conclusion: </strong>These PRO measures demonstrated content and psychometric validity and are ready for use in research and practice to better understand the impact of PP from the patient perspective.</p>\",\"PeriodicalId\":10814,\"journal\":{\"name\":\"Current Medical Research and Opinion\",\"volume\":\" \",\"pages\":\"1277-1290\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Medical Research and Opinion\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/03007995.2025.2537898\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Medical Research and Opinion","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/03007995.2025.2537898","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/31 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

摘要

背景:突出颈阔肌(PP)的特征是沿颈部长度呈垂直带,下颌线变钝,影响美观。目前还没有经过验证的患者报告结果(PRO)措施可用于评估PP患者的具体经历。目的:开发和验证符合目的的PRO措施,以捕获PP患者的经历和治疗结果。方法:根据FDA以患者为中心的药物开发指南,开发和验证PRO措施。3次访谈(概念启发[CE], N = 30;认知汇报[CD]第1轮,N = 20;第2轮(N = 5)研究对象为未接受治疗和之前接受过治疗的PP成人。工具是根据CE访谈中出现的概念起草的。采用二期PP治疗研究(ClinicalTrials.gov;NCT03915067)数据(N = 164)。虽然没有可用的金标准测量方法,但使用多个FACE-Q模块,参与者严重程度总体印象(PGIS)-下颌线和参与者治疗满意度总体印象(PGI-TS)来评估收敛和已知组效度。计算双向随机类内相关系数ICC(2,1)和Rλ来评估重测信度。对于ICC(2,1)和Rλ,值≥0.70被认为是成功的。草稿工具和共同验证者得分之间的Spearman相关性(𝜌)用于评估收敛效度(|𝜌|≥0.40)。此外,对多项目测量进行内部一致性信度检验,Cronbach's α≥0.70被认为是成功的。结果:50%的参与者报告说,“带状”或其变体(如绳状、脊状、线状)是描述PP最常用的术语。最常见的心理社会影响报告是看起来比预期年龄大(n = 28, 93.3%),感到自我意识(n = 24, 80.0%),感觉不那么有吸引力(n = 20, 66.7%),以及看起来不那么有吸引力和穿着不同(n = 19, 63.3%)。颈阔肌带突出度降低是最常被引用的能提高满意度的改变(n = 15.0%, 50.0%)。在CE访谈之后,起草了3项PRO测量:颈部和下面部外观问卷(ANLFQ):影响,ANLFQ:满意度(基线/随访)和BAS-PP。CD访谈显示,参加者认为问卷可理解及切合实际。在心理测试中,除了一些例外,主要符合既定的信度和效度标准。三个相关性低于0.40阈值,虽然这些相关性都在预期的方向上,但考虑到PP PROs和共同验证措施之间有限的概念一致性,它们的较小幅度并不意外。结论:这些PRO量表具有较好的内容和心理效度,可用于研究和实践,从患者的角度更好地了解PP的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of patient-reported outcome measures for platysma prominence.

Background: Platysma prominence (PP) is characterized by vertical bands along the length of the neck and blunting of the jawline, impacting aesthetic appearance. No validated patient-reported outcome (PRO) measures are available to assess patient experiences specific to PP.

Objective: Develop and validate fit-for-purpose PRO measures that capture patient experiences with PP and treatment outcomes.

Methods: PRO measures were developed and validated in alignment with the FDA's patient-focused drug development guidance. Three interviews (concept elicitation [CE], N = 30; cognitive debriefing [CD] round 1, N = 20; round 2, N = 5) were conducted with treatment-naive and previously treated adults with PP. Instruments were drafted based on concepts emerging from CE interviews. Psychometric testing for reliability and validity was conducted using phase 2 PP treatment study (ClinicalTrials.gov; NCT03915067) data (N = 164). While there were no available gold standard measures, convergent and known-groups validity were assessed using multiple FACE-Q modules, the Participant Global Impression of Severity (PGIS)-Jawline, and the Participant Global Impression of Treatment Satisfaction (PGI-TS). The 2-way random intraclass correlation coefficient ICC(2,1) and Rλ were calculated to evaluate test-retest reliability. Values of ≥0.70 were considered success for both the ICC(2,1) and Rλ. Spearman correlations (ρ) between scores from draft instruments and co-validators were used to assess convergent validity (|ρ|≥0.40). Additionally, internal consistency reliability was examined for multi-item measures where Cronbach's α ≥ 0.70 was considered success.

Results: "Bands" or a variation (e.g., cords, ridges, lines) were the most common terms used to describe PP, reported by 50% of participants. The most frequently reported psychosocial impacts were looking older than desired (n = 28, 93.3%), feeling self-conscious (n = 24, 80.0%), feeling less attractive (n = 20, 66.7%), and looking less attractive and dressing differently (both: n = 19, 63.3%). Reduced platysma band prominence was the most cited change that would increase satisfaction (n = 15, 50.0%). Following CE interviews, 3 PRO measures were drafted: Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, ANLFQ: Satisfaction (Baseline/Follow-up), and the Bother Assessment Scale-Platysma Prominence (BAS-PP). CD interviews indicated that participants found the questionnaires understandable and relevant. In psychometric testing, established criteria for reliability and validity were predominantly met, with some exceptions. Three correlations were under the 0.40 threshold, and while these correlations were all in the expected direction, their smaller magnitudes were not unexpected given the restricted conceptual alignment between the PP PROs and co-validating measures.

Conclusion: These PRO measures demonstrated content and psychometric validity and are ready for use in research and practice to better understand the impact of PP from the patient perspective.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Current Medical Research and Opinion
Current Medical Research and Opinion 医学-医学:内科
CiteScore
4.40
自引率
4.30%
发文量
247
审稿时长
3-8 weeks
期刊介绍: Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信