Faculty of Medicine, Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK
Faculty of Medicine, Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.
BMJ Open. 2021 Mar 19;11(3):e034047. doi: 10.1136/bmjopen-2019-034047.
To examine the acceptability and validity of two patient-reported outcome measures (PROMs) for adult acne, comparing them to the validated Acne-specific Quality of Life (Acne-QoL) measure.
Mixed-methods validation study.
Participants were recruited by (1) mail-out through primary care if they had ever consulted for acne and received a prescription for acne treatment within the last 6 months, (2) opportunistically in secondary care and (3) poster advertisement in community venues.
221 (204 quantitative and 17 qualitative) participants with acne, aged 18-50 years.
Quantitative sub-study participants completed Acne-QoL, Skindex-16 and Comprehensive Acne Quality of Life Scale (CompAQ) at baseline, 24 hours and 6 weeks. Qualitative sub-study participants took part in cognitive think-aloud interviews, while completing the same measures. Transcribed audio recordings were analysed using inductive thematic analysis.
Quantitative analyses suggested high internal consistency (Cronbach's alpha 0.74-0.96) and reliability (intraclass correlation coefficient values 0.88-0.97) for both questionnaires. Both scales showed floor effects on some subdomains. Skindex-16 and CompAQ showed good evidence of construct validity when compared with Acne-QoL with Spearman's correlation coefficients 0.54-0.81, and good repeatability over 24 hours.Qualitative data uncovered wide-ranging views regarding usability and acceptability. Interviewees held strong but differing views about layout, question/response wording, redundant/similar questions and guidance notes. Similarly, interviewees differed in perceptions of acceptability of the different scales, particularly on relatability of questions and emotive reactions to scales.
All PROMs performed well in statistical analyses. No PROM showed superior usability and acceptability in the qualitative study. Any PROM should be acceptable for further research in adult acne but researchers should consider the different domains and whether they will measure only facial or facial and trunk acne before making a selection. A new PROM or further evaluation of novel PROMs may be beneficial.
研究两种成人痤疮患者报告结局测量工具（PROM）的可接受性和有效性，并将其与经过验证的痤疮特异性生活质量（Acne-QoL）测量工具进行比较。
混合方法验证研究。
通过以下三种方式招募参与者：（1）通过初级保健机构邮件发送，如果参与者曾因痤疮就诊并在过去 6 个月内接受过痤疮治疗处方；（2）在二级保健机构中随机选择；（3）在社区场所张贴海报广告。
221 名（204 名定量和 17 名定性）年龄在 18-50 岁之间的痤疮患者。
定量子研究参与者在基线、24 小时和 6 周时完成了 Acne-QoL、Skindex-16 和综合痤疮生活质量量表（CompAQ）。定性子研究参与者在完成相同测量的同时，参加了认知性思考 aloud 访谈。对转录后的音频记录进行了归纳主题分析。
定量分析表明，两个问卷的内部一致性（Cronbach's alpha 0.74-0.96）和可靠性（组内相关系数值 0.88-0.97）均较高。两个量表在某些子领域都存在地板效应。与 Acne-QoL 相比，Skindex-16 和 CompAQ 的 Spearman 相关系数分别为 0.54-0.81，显示出良好的结构效度证据，且在 24 小时内具有良好的可重复性。定性数据揭示了关于可用性和可接受性的广泛观点。受访者对布局、问题/回答措辞、冗余/相似问题和指导说明持广泛但不同的看法。同样，受访者对不同量表的可接受性的看法也不同，特别是对问题的相关性和对量表的情绪反应。
所有 PROM 在统计分析中表现良好。在定性研究中，没有任何一种 PROM 在可用性和可接受性方面表现出优越性。任何 PROM 都可以用于成人痤疮的进一步研究，但研究人员在做出选择之前，应该考虑不同的领域以及他们是否只测量面部或面部和躯干痤疮。开发新的 PROM 或进一步评估新的 PROM 可能会有所帮助。
