van den Bosch Anna S, Farkas Melinda, Kemme Frederique M, Stoop Matthea M, van Zuijlen Paul P M, Meij-de Vries Annebeth, Middelkoop Esther, Pijpe Anouk
Alliance of Dutch Burn Care (ADBC), Burn Centre, Red Cross Hospital, Beverwijk, The Netherlands.
Department of Plastic, Reconstructive & Hand Surgery, Amsterdam UMC location VUmc, Amsterdam, The Netherlands.
Methods Mol Biol. 2025;2922:335-354. doi: 10.1007/978-1-0716-4510-9_26.
The clinical application of tissue engineered products aims to regenerate skin and enhance the appearance, texture, sensation, and functionality of affected skin or scars. To evaluate the efficacy and effectiveness of novel products, level 1 randomized controlled trials are required. However, currently a significant challenge in this field is the clinical and statistical heterogeneity of trial designs and outcome measures for tissue engineered products. To address this challenge and improve clinical outcomes, it is essential to standardize high-quality outcome measures. These measures are clinimetrically developed tools designed to reliably and validly assess specific health outcomes across diverse patient populations, clinical settings, and studies. This chapter proposes a core set of outcome measurements designed to evaluate the most relevant, feasible, reliable, and valid parameters in the clinical application of tissue engineered products. For routine clinical practice, we recommend the inclusion of photography, graft take, re-epithelialization, and scar quality assessment using the Patient and Observer Scar Assessment Scale. For clinical trials, additional measures such as colorimetry and elasticity assessment are advised. Detailed protocols for these methods are provided, resulting in a standardized core outcome set. High-quality outcome assessment also necessitates specialized training and the presence of trained personal at all assessment points. The chapter further addresses specific considerations for outcome assessment in pediatric patients, remote assessment strategies, and additional recommendations for optimizing clinical and research practices in this field. The implementation of standardized outcome measurement is essential for improving the outcomes of patients treated with tissue engineered products.
组织工程产品的临床应用旨在再生皮肤并改善受影响皮肤或疤痕的外观、质地、感觉和功能。为了评估新产品的疗效和有效性，需要进行一级随机对照试验。然而，目前该领域的一个重大挑战是组织工程产品试验设计和结果测量的临床和统计异质性。为应对这一挑战并改善临床结果，标准化高质量的结果测量至关重要。这些测量是通过临床测量学开发的工具，旨在可靠且有效地评估不同患者群体、临床环境和研究中的特定健康结果。本章提出了一组核心结果测量指标，旨在评估组织工程产品临床应用中最相关、可行、可靠和有效的参数。对于常规临床实践，我们建议采用摄影、移植物存活、再上皮化以及使用患者和观察者疤痕评估量表进行疤痕质量评估。对于临床试验，建议采用比色法和弹性评估等额外测量方法。文中提供了这些方法的详细方案，从而形成了一个标准化的核心结果集。高质量的结果评估还需要专门培训以及在所有评估点配备经过培训的人员。本章还讨论了儿科患者结果评估的具体注意事项、远程评估策略以及优化该领域临床和研究实践的其他建议。实施标准化结果测量对于改善接受组织工程产品治疗患者的治疗效果至关重要。
