扁平苔藓PRP治疗的方法学考虑:解决潜在的偏见

IF 2.3 4区 医学 Q2 DERMATOLOGY
Mathias Willaert, DirkJan Hijnen, Rick Waalboer-Spuij
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引用次数: 0

摘要

Behrangi等人(2024)在《美容皮肤病学杂志》上发表了一篇题为“富血小板血浆作为一种新的、成功的平栉苔藓治疗方法:一项对照盲法随机临床试验”的文章,我们正在撰写这篇文章。该研究为富血小板血浆(PRP)治疗扁平苔藓(LPP)提供了有价值的数据;然而,我们希望解决一个与可能影响研究结果的表现偏差相关的重要方法学问题。研究设计采用单盲方法,只有结果评估者对治疗组进行盲测。尽管如此,参与者知道他们是在服用氯倍他索的同时服用PRP还是单独服用氯倍他索。在参与者中缺乏盲法引入了表现偏差的风险。这种类型的信息偏差在像LPP这样的情况下尤其显著,因为主观症状——如瘙痒、疼痛和灼烧——在结果评估中起着至关重要的作用。患者意识到接受被认为是更新颖或更先进的治疗(在这种情况下,PRP)可能会期望更大的改善并报告更好的结果。这种期望会影响他们对症状的主观报告,可能导致对治疗效果的高估。相反,控制组的患者可能报告的改善较少,因为他们的期望值较低,即使他们经历了类似的生理益处。了解治疗组的心理影响可以显著影响患者报告的结果,这是涉及主观症状负担的慢性病研究的核心。此外,本研究中使用的扁平苔藓活动指数(LPPAI)严重依赖于患者报告的症状,特别容易受到这种偏差的影响。PRP组和对照组之间症状报告的差异可能会扭曲PRP的疗效,从而使研究结果的解释复杂化。该研究的结论是PRP在治疗LPP方面优于氯倍他索,这可能部分归因于这种偏倚,而不是治疗的内在功效。为了减轻表现偏差,双盲设计,参与者和评估者都不知道治疗分配将解决这个问题。这种方法将减少患者期望对症状报告的影响,更清楚地了解PRP治疗LPP的真实疗效。鉴于这些担忧,我们建议未来对LPP或类似情况的PRP研究采用双盲方法,以确保更可靠和公正的结果。这样的设计将提高研究结果的有效性,并支持在临床实践中关于PRP疗效的更有力的结论。马蒂亚斯·威拉尔特:概念,方法论,写作-原稿准备。DirkJan Hijnen和Rick Waalboer-Spuij:概念化,监督。作者没有什么可报道的,d.j.h。曾担任AbbVie、Almirall、Galderma、LEO pharma和Sanofi的研究员,并担任AbbVie、Eli Lilly、Galderma、Pfizer和LEO pharma的顾问。M.W.和r.w.s。声明没有利益冲突。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Methodological Considerations in PRP Treatment for Lichen Planopilaris: Addressing Potential Bias

We are writing in response to the recent publication titled “Platelet-Rich Plasma as a New and Successful Treatment for Lichen Planopilaris: A Controlled Blinded Randomized Clinical Trial” by Behrangi et al. (2024) in the Journal of Cosmetic Dermatology. The study contributes valuable data on the use of platelet-rich plasma (PRP) for lichen planopilaris (LPP); however, we wish to address a significant methodological issue related to performance bias that could have influenced the study's outcomes.

The study design involved a single-blinded approach, where only the outcome assessor was blinded to the treatment groups. Nonetheless, the participants were aware of whether they were receiving PRP in addition to clobetasol or clobetasol alone. This lack of blinding among participants introduces a risk of performance bias. This type of information bias is particularly significant in a condition like LPP where subjective symptomatology—such as pruritus, pain, and burning—plays a crucial role in outcome assessment.

Patients aware of receiving what is perceived as a more novel or advanced treatment (in this case, PRP) might expect greater improvement and report better outcomes. This expectation can influence their subjective reporting of symptoms, potentially leading to an overestimation of the treatment's effectiveness. Conversely, patients in the control group might report less improvement because of lower expectations, even if they experience similar physiological benefits. The psychological impact of knowing one's treatment group can significantly affect patient-reported outcomes, which are central to studies involving chronic conditions with a subjective symptom burden.

Moreover, the Lichen Planopilaris Activity Index (LPPAI) used in this study, which heavily relies on patient-reported symptoms, is particularly vulnerable to such bias. The differences in symptom reporting between the PRP and control groups could skew the perceived efficacy of PRP, thereby complicating the interpretation of the study's findings. The study's conclusion that PRP is superior to clobetasol in managing LPP might be partially attributable to this bias rather than the treatment's inherent efficacy.

To mitigate performance bias, a double-blinded design where both participants and assessors are unaware of the treatment allocation would address this issue. This approach would reduce the influence of patient expectations on symptom reporting, providing a clearer picture of the true efficacy of PRP in treating LPP.

In light of these concerns, we recommend that future studies on PRP for LPP or similar conditions employ a double-blinded methodology to ensure more reliable and unbiased results. Such a design would enhance the validity of the findings and support more robust conclusions about the efficacy of PRP in clinical practice.

Mathias Willaert: conceptualization, methodology, writing – original draft preparation. DirkJan Hijnen and Rick Waalboer-Spuij: conceptualization, supervision.

The authors have nothing to report.

D.J.H. served as the investigator for AbbVie, Almirall, Galderma, LEO pharma, and Sanofi, and as a consultant for AbbVie, Eli Lilly, Galderma, Pfizer, and LEO pharma. M.W. and R.W.-S. declare no conflicts of interest.

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来源期刊
CiteScore
4.30
自引率
13.00%
发文量
818
审稿时长
>12 weeks
期刊介绍: The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.
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