Volume 44 Number 3

Evolution and evidence in convexity

Paris Purnell

For referencing Purnell P. Foreword: Evolution and evidence in convexity. WCET® Journal Supplement 2024;44(3)Sup:s2.

DOI 10.33235/wcet.44.3.sup.s2

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Author(s)

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中文

While convexity products for ostomy care have been available now for decades, until recently, there has been a dearth of evidence and fragmented citations supporting their usage.1,3 Additionally, product descriptors and accompanying nomenclature have been both primarily subjective and, as such, confusing.1 Relying on clinician interpretation of such descriptors and the clinician’s individual experiences in using these products neither supports evidence-based practice, nor aids in developing educational frameworks for the novice clinician when choosing convex skin barriers.

The first concept to reach the market in around 2001, of the more compressible and flexible convex products2 (commonly referred to as ‘soft’), was quickly followed by products from other manufacturers and proved a boon to the clinician in helping solve clinical challenges. Often seen as the ‘safer’ option to their less compressible and flexible counterparts1 (‘firm convex’), this wider range of options now helps to further complete the clinician’s armamentarium in managing their patients. However, while these newer convexity additions have quickly become popular, they also lacked clinical guidance and once again, descriptors and indications for use lack objectivity.1,3 Furthermore, there are no regulatory bodies, such as the International Standards Organisation (ISO), governing any convex products for ostomy product manufacturers regarding specific measurements.1,3 While more products are being introduced and accompanying evidence is being produced, standards have yet to follow.

In 2013, a comprehensive literature review was undertaken with an accompanying publication that identified these gaps in evidence and nomenclature.1 Myths around convexity use in the clinical setting were explored, questioned and in part debunked based on the paucity of evidence.1 Such myths included the historical recommendations that convexity was the cause of mucocutaneous separation in the post-operative period and thus, should be avoided. Additionally, contraindications led to cautionary statements around specific peristomal skin disorders, such as pyoderma gangrenosum or caput medusae, and the use of convexity. This publication became the catalyst in generating the more recent evidence that was soon to follow.

This supplement explores the current landscape in the journey of the evolution of evidence in convexity products and their use, the potential for the future, and changes to clinical practice resulting from such evidence – evidence-based practice. In the first section, The role of standardised product terminology in product development and clinical practice, Czaplewski and Smitka revisit the five characteristics of convexity. Published in 2021, these product characteristics and clinical practice impact statements have been instrumental in how clinicians and manufacturers frame discussions about convexity products.3 Setting common nomenclature will be influential for both research opportunities and novice nurse education, as clinicians can now describe specific convexity attributes and the clinical decision making for correct product selection.3 Also described are how these descriptors are already influencing current and future product development with recommendations for the future.

In the next article, The World is No longer flat, authors Malandrino, Skountrianos, Simmons, Walker and Drolshagen fuse together the existing pieces of evidence regarding convexity products, peristomal skin complication rates, and link to the need for creating evidence-based practice. Additionally, they discuss the impact evidence has had on clinical practice, as well as discussing the rationale for choosing convexity earlier in the patient journey to help optimise patient outcomes.

In the third article, Translating the evidence into clinical practice – a journey through change, author Hill describes her recent journey in making changes to her practice based on evidence. Recent publications and conference symposia describing convexity earlier in the patient journey were catalysts in triggering her recognition of the significant physical and psychological challenges placed on her patients by early leakage. She describes using the Lewin Model of Change in facilitating transformation in practice and prescribing at her institution. Change can be both arduous and daunting, yet vital, if a real, positive change is to occur and Hill discusses her process and suggests recommendations for the future.

In conclusion, Purnell summarises these findings with recommendations for future opportunities in both evidence generation and product development. There are still significant developments to occur concerning manufacturing standards for convexity products, new product introductions, proactive decision-making vs reactive decision-making, as well as ongoing evidence generation supporting evidence-based practices.


凸面装置的演变与使用证据

Paris Purnell

DOI: 10.33235/wcet.44.3.sup.s2

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虽然用于造口护理的凸面产品已问世数十年,但直到最近,支持使用这些产品的证据和引文依旧十分匮乏。1,3此外,产品描述词及相关术语大多基于主观判断,这无疑増加了理解的难度。1依赖临床医生对产品描述词的理解以及他们在使用这些产品时的个人经验,既无法为循证实践提供有力支持,也不利于为新手临床医生选择凸面皮肤底盘搭建教育框架。

2001年左右,首个概念产品Å\Å\一种可压缩性、柔韧性更强的凸面产品2(通常称为“软产品”)进入市场,其他制造商的产品也迅速跟进,这种产品的出现帮助临床医生解决了许多临床难题。与可压缩性和柔韧性较低的同类产品1(“坚硬凸面”)相比,这种产品通常被视作“更安全”的选择。如今,这种更为广泛的选择进一步充实了临床医生管理患者时的工具库。然而,尽管这些新的凸面装置迅速受到欢迎,但也缺乏临床指导,产品描述词和使用适应症仍然缺乏客观性。1,3再加上没有如国际标准化组织(ISO)这样的监管机构来规定造口产品制造商的具体测量标准。1,3尽管新产品不断涌现并且相关的证据也在増加,但统一的标准尚未形成。

2013年,有研究者进行了一次全面的文献综述,并发表了相关文章,该文章指出了证据和术语方面的差距。1文章对临床环境中关于凸面装置使用的误解进行了探讨,提出了质疑,并在一定程度上揭穿了证据不足的说法。1这些误解包括历史性的建议,即认为术后应避免使用凸面产品以防止皮肤黏膜分离。此外,对于某些特定的造口周围皮肤疾病,例如坏疽性脓皮病或脐周静脉曲张,也有禁忌症指出不宜使用凸面产品。这一出版物成为后续更多证据产生的催化剂。

本増刊探讨了凸面产品及其使用的证据演变历程中的现状、未来的潜力以及由这些证据引发的临床实践变化Å\Å\循证实践。在第一部分,《标准化产品术语在产品开发和临床实践中的作用》一文中,Czaplewski和Smitka回顾了凸面装置的五个特征。这些产品特征及临床实践影响声明在2021年发布后,有助于临床医生和制造商构建关于凸面产品的讨论。3制定通用术语将对研究机会和护士新手教育产生影响,因为临床医生现在可以描述特定的凸面装置属性和正确选择产品的临床决策。3文章还描述了这些描述词如何已经影响到当前和未来的产品开发,并对未来提出了建议。

在下一篇文章《告别平面时代》中,Malandrino、Skountrianos、Simmons、Walker和Drolshagen结合关于凸面装置、造口周围皮肤并发症发生率的现有证据,探讨了创建循证实践的需求。此外,他们还讨论了这些证据对临床实践的影响,并讨论了在患者治疗过程中较早选择凸面装置以帮助改善患者结局的理由。

在第三篇文章《将证据转化为临床实践Å\Å\变革之旅》中,作者Hill描述了她近期依据证据对其临床实践进行变革的经历。最近发表的文章和会议专题讨论会对患者早期的凸面装置进行了描述,这促使她认识到早期渗漏给患者带来的巨大生理和心理挑战。她介绍了自己所在机构采用Lewin变革模型促进实践和处方转型的过程。若要实现真正的、积极的变革,这一过程或许艰难且令人心生畏惧,然而却极为关键。Hill阐释了她的变革历程,并对未来给出了建议。

最后,Purnell对这些研究结果进行了归纳总结,并针对未来在证据生成和产品开发方面的机遇提出了建议。在凸面产品的制造标准、新产品的推出、主动决策与被动决策以及支持循证实践的持续证据生成等方面,仍有诸多工作亟待完成。


Author(s)

Paris Purnell
Senior Manager, Clinical Education
Hollister Incorporated, Libertyville, Illinois, USA
Email paris.purnell@hollister.com

References

  1. Hoeflok J, Kittscha J, Purnell P. Use of convexity in pouching -
  2. A comprehensive review. JWOCN. 2013;40:506–512.
  3. Welland Medical. History of Welland. Welland Medical. Accessed November 2023. https://wellandmedical.com/wp-content/themes/welland/timeline.html
  4. Cobb T, Depaifve Y, Quigley M. et al. Characteristics of convex skin barriers and clinical application – Results of an international consensus panel. JWOCN. 2021; 48: 524–532.