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Colorectal Dis. 2019 Nov 8. doi: 10.1111/codi.14899. [Epub ahead of print]

Establishing core outcome sets for gastrointestinal recovery in studies of postoperative ileus and small bowel obstruction: protocol for a nested methodological study.

Author information

1
Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, UK.
2
Academic Directorate of General Surgery, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
3
Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.
4
Patient Representative, Liverpool, UK.
5
Patient Representative, Green Templeton College, Oxford, UK.
6
Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands.
7
Department of Colorectal Surgery, Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio, USA.
8
Discipline of Surgery, Faculty of Health and Medical Science, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
9
Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
10
Department of Surgery, Maulana Azad Medical College, New Delhi, India.
11
Department of Surgery, Faculty of Medicine and Health Sciences, University of Auckland, Auckland, New Zealand.
12
Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
13
Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
14
Department of Surgery, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
15
Department of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium.
16
Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

Abstract

INTRODUCTION:

Gastrointestinal recovery describes the restoration of normal bowel function in patients with bowel disease. This may be prolonged in two common clinical settings: postoperative ileus and small bowel obstruction. Improving gastrointestinal recovery is a research priority but researchers are limited by variation in outcome reporting across clinical studies. This protocol describes the development of core outcome sets for gastrointestinal recovery in the contexts of postoperative ileus and small bowel obstruction.

METHOD:

An international Steering Group consisting of patient and clinician representatives has been established. As overlap between clinical contexts is anticipated, both outcome sets will be co-developed and may be combined to form a common output with disease-specific domains. The development process will comprise three phases, including definition of outcomes relevant to postoperative ileus and small bowel obstruction from systematic literature reviews and nominal-group stakeholder discussions; online-facilitated Delphi surveys via international networks; and a consensus meeting to ratify the final output. A nested study will explore if the development of overlapping outcome sets can be rationalized.

DISSEMINATION AND IMPLEMENTATION:

The final output will be registered with the Core Outcome Measures in Effectiveness Trials initiative. A multi-faceted, quality improvement campaign for the reporting of gastrointestinal recovery in clinical studies will be launched, targeting international professional and patient groups, charitable organizations and editorial committees. Success will be explored via an updated systematic review of outcomes 5 years after registration of the core outcome set.

KEYWORDS:

Ileus; core outcome set; small bowel obstruction

PMID:
31701620
DOI:
10.1111/codi.14899

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