RAMBO: Research Assessment Outcome Measures for Malignant Bowel Obstruction

Information

Principal Investigator:  Professor Simon Noble                
Researcher:  Elin Baddeley  
Funder: Marie Curie (MCRGS-20171220-8020)                                    
General enquiries: Elin Baddeley

Start Date: 01 Apr 2019
End date:  31 Mar 2022
Status:Reporting
Ethics Approval: This study was approved by the Wales Research Ethics Committee (Wales REC 5) on 10th December 2019 (Ref 19/WA/0340).
Research Networks: Health Wise Wales, Public Health Wales, Councils, Charities, Universities, and other public organisation across Wales promoted recruitment.

Background

Malignant bowel obstruction (MBO) is a common problem faced by patients with advanced cancer. MBO is when the cancer causes a blockage or blockages in the bowel. The symptoms are very distressing for patients and their families with large, frequent vomits, which may contain part-digested food. In addition, people with MBO may feel sick and bloated, have painful stomach cramps, and be constipated. The vomiting caused by MBO stops patients from keeping food or water down, making it hard for the person to be cared for at home. An operation is usually not possible, and treatment aims to ease symptoms using injections and/or tubes to drain any build-up of fluid in the stomach.

There have been some studies about how to manage MBO, but they have used varied measurements. This makes it impossible to compare studies and agree on the best treatment. Also, as they have not been formally asked, it is not known if the measures we use are important to the patient and their families or whether they are just the ones that researchers, doctors or nurses think are important.

As a first step, we wanted to agree a standard way of measuring MBO symptoms important to patients, so treatments can immediately be tested consistently in hospitals, hospices and in patients’ homes, both in care and in research studies. To do this we started with what we already know by looking at the published research. We then asked patients and their companions what is most important to them. We compared this to understand the current gaps and limitations in research of measuring MBO symptoms. Finally, we worked with patients, family representatives, researchers, and clinicians to agree together on what measures should be used in the future.

Aims

1. To review the current scope of outcome measures used to evaluate MBO though answering the following questions.

• What outcome measures are currently used to evaluate MBO within the context of clinical studies and practice?
• What symptoms and effects do patients with MBO, their carers and clinicians consider most important, and what improvement would be considered clinically meaningful?
• How do currently used outcomes map to those important to patients, carers and clinicians, and, in consequence, what are the gaps and limitations in current practice?

2. To develop a set of core outcomes that is specific to MBO.

Progress

Reporting stage:

Baddeley E, Mann M, Bravington A, Johnson MJ, Currow D, Murtagh FE, Boland EG, Obita G, Oliver A, Seddon K, Nelson A. Symptom burden and lived experiences of patients, caregivers and healthcare professionals on the management of malignant bowel obstruction: A qualitative systematic review. Palliative Medicine. 2022 Mar 8:02692163221081331.

Bravington A, Obita G, Baddeley E, Johnson MJ, Murtagh FE, Currow DC, Boland EG, Nelson A, Seddon K, Oliver A, Noble SI. The range and suitability of outcome measures used in the assessment of palliative treatment for inoperable malignant bowel obstruction: A systematic review. Palliative Medicine. 2022 Oct;36(9):1336-50.

Baddeley E, Bravington A, Johnson M, Currow DC, Murtagh FE, Boland E, Obita G, Nelson A, Seddon K, Oliver A, Noble S. Development of a core outcome set to use in the research and assessment of malignant bowel obstruction: protocol for the RAMBO study. BMJ open. 2020 Jun 1;10(6):e039154.

Methods

Full details of the study methods are available in the published protocol paper. The final results paper will be published shortly.