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Development of a core outcome set to use in the research and assessment of malignant bowel obstruction: protocol for the RAMBO study

Baddeley, Elin; Bravington, Alison; Johnson, Miriam; Currow, David; Murtagh, Fliss Em; Boland, Elaine; Obita, George; Nelson, Annmarie; Seddon, Kathy; Oliver, Alf; Noble, Simon; Boland, Jason

Authors

Elin Baddeley

Alison Bravington

David Currow

Elaine Boland

George Obita

Annmarie Nelson

Kathy Seddon

Alf Oliver

Simon Noble

Jason Boland



Abstract

INTRODUCTION: Studies regarding the management of malignant bowel obstruction (MBO) report conflicting findings. This is partly due to different outcome measures being used to evaluate severity of MBO and the response to treatments. Furthermore, current outcome measures focus mainly on measurable physiological parameters which may not correlate strongly with patient-defined quality of life. The development of core outcome sets allows a consistent approach to evaluating clinical conditions taking into consideration patient, healthcare professional and researcher viewpoints. It follows an internationally recognised standard methodology. We present a protocol for the development of a core outcome set for Research and Assessment of MBO (RAMBO). METHODS: RAMBO is a multicentre study, comprising of four phases: a systematic review to examine current scope of outcome measures associated with MBO (phase I). Interviews with patients, companions and healthcare professionals will explore priorities and preferences for care and outcomes (phase II). An expert panel meeting will collate the findings into a set of outcomes (phase III), refined by consensus through a Delphi survey with key stakeholders (phase IV). The final set of outcomes will be ratified at a consensus meeting. Each step will actively include patient partners. Thematic analysis and descriptive statistics will be used to analyse qualitative and quantitative data, respectively. ETHICS AND DISSEMINATION: Ethical approval was obtained (Wales REC 5, REF: 19/LO/1876). Study participants and relevant stakeholders will be updated with newsletters and a lay summary at the end of the study. Abstracts will be submitted to national and international conferences, result papers will be submitted to peer-reviewed, open access journals. TRIAL AND PROSPERO REGISTRATION NUMBERS: Core Outcome Measures in Effectiveness Trials (1402); Systematic Literature Review (CRD42019150648); Rapid Review (CRD42020176393).

Journal Article Type Article
Publication Date Jun 28, 2020
Journal BMJ open
Print ISSN 2044-6055
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 10
Issue 6
Article Number 039154
APA6 Citation Currow, D. C., Currow, D. C., Murtagh, F. E., Oliver, A., Baddeley, E., Bravington, A., …Boland, J. (2020). Development of a core outcome set to use in the research and assessment of malignant bowel obstruction: protocol for the RAMBO study. BMJ open, 10(6), https://doi.org/10.1136/bmjopen-2020-039154
DOI https://doi.org/10.1136/bmjopen-2020-039154
Publisher URL https://bmjopen.bmj.com/content/10/6/e039154

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© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.





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