NIHR Global Health Research Unit on Global Surgery, University of Birmingham, Institute of Translational Medicine, Birmingham, UK.
Br J Surg. 2023 May 16;110(6):685-700. doi: 10.1093/bjs/znad058.
The Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation.
This was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model.
In the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach's α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever).
This study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways.
Bluebelle 伤口愈合问卷（WHQ）是一种通用报告结局测量工具，在英国开发，用于远程检测腹部手术后的手术部位感染。本研究旨在探索 WHQ 在低中等收入国家使用的跨文化等效性、可接受性和内容有效性，并提出其改编建议。
这是一项混合方法研究，嵌入在一项国际随机试验（SWAT）中，根据最佳实践指南进行，并与社区和患者合作伙伴（TALON-1）共同开展。使用结构化访谈和焦点小组收集有关个体项目和量表的跨文化、跨情境等效性的数据，并进行可翻译性评估。根据 Mapi 建议，将翻译完成成五种语言。接下来，使用 Rasch 分析对前瞻性队列（SWAT）的数据进行解释，以探讨 WHQ 的定标和测量特性。最后，使用改良的、探索性的、仪器设计模型对定性和定量数据进行三角剖分。
在定性阶段，来自六个国家的 47 名调查员共进行了 10 次结构化访谈和 6 次焦点小组。确定了与理解、反应映射、检索和判断相关的主题，并提供了丰富的跨文化见解。在定量阶段，根据 Rasch 模型拟合了 537 名患者的数据（369 名排除极值）。由于极端值（地板值）的数量较多，整体功效较低。单一的 WHQ 量表满足了有序总 WHQ 评分的维度性测试。有 5 个项目（5、9、14、15、16）和 11 个项目对整体模型拟合不良，存在局部依赖性。人的分离指数估计为 0.48，表明类别之间的区分度较弱，而 Cronbach's α 为 0.86，较高。定性数据与 Rasch 分析的三角剖分支持 WHQ 项目 1（红肿）、3（清亮液）、7（深部伤口开口）、10（疼痛）、11（发热）、15（抗生素）、16（清创术）、18（引流）和 19（再手术）的跨文化适应建议。对症状项目 1 至 10 的三个项目反应类别（1，一点也不；2，有点；3，很多）进行了修改，并对项目 11（发热）的两个类别（0，否；1，是）进行了修改。
本研究使用来自三大洲的合作产生的混合方法数据，为 WHQ 在全球外科研究和实践中的跨文化适应提出了建议。现在提供了翻译版本，可用于远程伤口评估途径。
