Core Outcome Measures in Effectiveness Trials

RAMBO: Research Assessment outcome measures for Malignant Bowel Obstruction

General Information

Summary:
Malignant bowel obstruction affects people with advanced ovarian (10%-50%) and gastrointestinal cancers (15%) and remains a challenging condition facing palliative care teams. It has a persistent and profound effect on quality of life, and often requires hospitalisation for persistent, unresolved symptoms.

Management options for MBO in patients with advanced cancer are limited; the majority of cases present with multiple level obstructions not amenable to surgical intervention. Non-surgical palliative approaches for inoperable MBO (IMBO) usually involve a combination of antiemetics and parenteral anti-secretory agents (anticholinergics or somatostatin analogues and H2 antagonists), often with gut decompression (nasogastric tube or venting gastrostomy).

The current evidence informing the palliation of MBO is inadequate; clinical guidelines favour somatostatin analogues but recommendations are based largely on case series and insufficiently powered clinical trials. Recently, two adequately powered, well-conducted clinical trials demonstrated no objective benefit and one suggested evidence of harm. Additionally, a recent systematic review of somatostatin analogues, using objective tools to evaluate data quality, concluded that there was moderate evidence of no benefit, and only poor evidence for their use. The authors acknowledged the challenges of evaluating current data given the varied clinical outcomes used and the lack of an agreed core outcome set (COS) for consistent clinical and research evaluation of MBO. Most importantly, there are no data to indicate that the current commonly used outcome measures reflect what is important to patients experiencing MBO and their companions (next of kin/carers), and the benefit they consider to be clinically meaningful.

The lack of consistent or confirmed patient-relevant outcome measures for MBO has led to varied evaluation of MBO across clinical trials, with inconsistent recommendations in clinical guidelines. Arguably the continuation of poorly evidenced clinical practice may cause also harm. Recent publications have called for the development of a core outcome set (COS), to ensure uniformity of symptom assessment within clinical trials and clinical practice.

Contributors:
Professor Simon Noble - Chief Investigator (Cardiff University)
Dr Jason Boland - Co-Chief Investigator (Hull York Medical School, HYMS)

Co-investigators:
Professor Miriam Johnson (HYMS)
Professor David Currow (HYMS and University of Technology Sydney)
Professor Annmarie Nelson (Cardiff University)
Professor Fliss Murtagh (HYMS)
Dr Elaine Boland (Queens Centre for oncology and haematology, Hull)
Dr George Obita (Dove House Hospice)
Dr Kathy Seddon (PPI Lead, Cardiff University)

Researchers:
Dr Alison Bravington (HYMS)
Elin Baddeley (Cardiff University) *primary contact: Please email baddeleye1@cardiff.ac.uk

Further Study Information

Current Stage:
Ongoing
Date:
April 2019 - November 2020
Funding source(s):
Marie Curie Research Grants Scheme (Grant Ref: MCRGS-20171220-8020)

Health Area

Disease Category
Cancer

Disease Name
Malignant bowel obstruction

Target Population

Age Range
18 - 120

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Consensus meeting
Delphi process
Interview
Literature review
Systematic review

A systematic review will be conducted in order to ascertain what outcome measures are used to evaluate MBO within the context of clinical research and practice. In addition, interviews will be conducted with patients (alongside companions/carers should they wish to be involved) and also interviews with healthcare professionals involved in the management of MBO. Interviews aim to discover what symptoms and effects do patients with MBO, their companions and clinicians consider most important, and what improvement would they consider clinically meaningful. The results of the systematic review and interviews will inform an expert panel group meeting in which the most prominent themes will aid the development of a Delphi survey and subsequent Delphi Rounds until consensus is achieved.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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