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一种用于评估术后胃肠道恢复情况的患者报告结局指标(PRO-diGI)的开发。

Development of a patient-reported outcome measure for gastrointestinal recovery after surgery (PRO-diGI).

作者信息

Lee Matthew J, Baker Daniel M, Hawkins Debby, Blackwell Sue, Arnott Robert, Harji Deena, Thorpe Gabrielle, Chapman Stephen J, Jones Georgina L

机构信息

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.

出版信息

Br J Surg. 2025 Mar 28;112(4). doi: 10.1093/bjs/znaf055.


DOI:10.1093/bjs/znaf055
PMID:40207689
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11983275/
Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

摘要

背景: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。 方法: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。 结果: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。 结论: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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/262f0c9a22b6/znaf055f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/77f78e08362d/znaf055f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/a3f417e4a072/znaf055f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/86f8ddb45505/znaf055f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/262f0c9a22b6/znaf055f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/77f78e08362d/znaf055f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/a3f417e4a072/znaf055f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/86f8ddb45505/znaf055f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9302/11983275/262f0c9a22b6/znaf055f4.jpg

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本文引用的文献

[1]
Formation of a conceptual framework during the development of a patient-reported outcome measure for early gastrointestinal recovery: phase I of the PRO-diGi study.

Colorectal Dis. 2023-10

[2]
Global cost of postoperative ileus following abdominal surgery: meta-analysis.

BJS Open. 2023-5-5

[3]
Screening for malnutrition in emergency laparotomy patients: a comparison of three tools.

Ann R Coll Surg Engl. 2023-5

[4]
Core outcome set for clinical studies of postoperative ileus after intestinal surgery.

Br J Surg. 2022-5-16

[5]
A core outcome set for clinical studies of adhesive small bowel obstruction.

Colorectal Dis. 2022-10

[6]
U.S. trends in elective and emergent major abdominal surgical procedures from 2002 to 2014 in older adults.

J Am Geriatr Soc. 2021-8

[7]
Postoperative Ileus.

Clin Colon Rectal Surg. 2019-5

[8]
Systematic review of definitions and outcome measures for return of bowel function after gastrointestinal surgery.

BJS Open. 2018-10-1

[9]
COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures.

Qual Life Res. 2017-12-19

[10]
GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research.

BMJ. 2017-8-2

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