Lee Matthew J, Baker Daniel M, Hawkins Debby, Blackwell Sue, Arnott Robert, Harji Deena, Thorpe Gabrielle, Chapman Stephen J, Jones Georgina L
Department of Applied Health Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Division of Clinical Medicine, Sheffield Medical School, University of Sheffield, Sheffield, UK.
Br J Surg. 2025 Mar 28;112(4). doi: 10.1093/bjs/znaf055.
After major abdominal surgery, patients may experience significant gastrointestinal dysfunction, including postoperative ileus. Many clinical tools are used to measure this dysfunction, but there is no patient-reported outcome measure (PROM) specific to this group. The aim of this study was to develop a new PROM for this common condition.
A four-stage approach was undertaken. Stage 1 used semi-structured interviews with 29 patients to explore experiences of gastrointestinal recovery and develop a draft questionnaire. Stage 2 solicited feedback from 18 patients and 15 clinical experts on the face validity of the proposed tool using the Questionnaire on Questionnaires (QQ-10). Stage 3 recruited 297 patients to complete the questionnaire. Principal component analysis reduced the items and identified the domain structure. Test-retest reliability and a pilot assessment of responsiveness were assessed in stage 4 in a sample of 100 patients and in a sample of 68 patients respectively.
The interviews generated 26 subthemes across gastrointestinal recovery and general well-being. An initial questionnaire containing 44 items was developed. The QQ-10 demonstrated high value and low burden, supporting face validity. Tests to reduce the items and identify the domain structure resulted in a 15-item questionnaire across four domains (nausea, eating, well-being, and bowels). Test-retest reliability showed intraclass correlation coefficient values ≥0.7 for all domains. Pilot responsiveness was demonstrated through differences in pre- and post-surgical scores.
PRO-diGI is a PROM for gastrointestinal dysfunction after major abdominal surgery that shows good psychometric properties and demonstrates face validity, reliability, and responsiveness. This now needs external validation to facilitate broader implementation.
腹部大手术后，患者可能会出现明显的胃肠功能障碍，包括术后肠梗阻。许多临床工具用于测量这种功能障碍，但尚无针对该群体的患者报告结局指标（PROM）。本研究的目的是为这种常见情况开发一种新的PROM。
采用四阶段方法。第1阶段对29名患者进行半结构化访谈，以探索胃肠功能恢复的经历并制定问卷初稿。第2阶段使用问卷质量问卷（QQ-10）征求18名患者和15名临床专家对所提议工具表面效度的反馈。第3阶段招募297名患者完成问卷。主成分分析减少了条目数量并确定了领域结构。第4阶段分别在100名患者样本和68名患者样本中评估了重测信度和反应性的初步评估。
访谈产生了26个关于胃肠功能恢复和总体健康状况的子主题。开发了一份包含44个条目的初始问卷。QQ-10显示出高价值和低负担，支持表面效度。减少条目数量并确定领域结构的测试产生了一份包含四个领域（恶心、饮食、健康状况和肠道）的15个条目的问卷。重测信度显示所有领域的组内相关系数值≥0.7。通过手术前后评分的差异证明了初步反应性。
PRO-diGI是一种用于腹部大手术后胃肠功能障碍的PROM，具有良好的心理测量特性，并显示出表面效度、信度和反应性。现在需要进行外部验证以促进更广泛的应用。
