Core outcome sets for gynaecological conditions (COGS)
Research type
Research Study
Full title
Development of core outcomes sets to standardise reporting in gynaecological conditions
IRAS ID
147729
Contact name
Stamatina Iliodromiti
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
SGL013\1008, Academy of Medical Sciences grant reference number; Strutt and Harper 2015, BMA Strutt and Harper grant reference number
Duration of Study in the UK
5 years, 0 months, 31 days
Research summary
The results of a clinical trial are reported as ‘outcomes’. A commonly used outcome in cancer is ‘survival’. When there are multiple trials examining the same condition, researchers try to put the results together so that they have a larger trial and a stronger result. This method is used when developing clinical guidelines. Unfortunately, trials don’t always report the same outcomes and even if they do, they might measure them differently; thus the results cannot be combined and guideline recommendations have to be based on less robust evidence. If rules were developed that ensured that trials examining the same disease all had to report the same outcomes it would be easier to combine results and develop guidelines based on the strongest available evidence.
Our aim is to develop ‘rules’ for 4 gynaecological conditions; heavy menstrual bleeding, fertility sparing surgery for cervical cancer, endometrial cancer and endometrial hyperplasia. We will decide which outcomes should be reported for each disease based upon the opinions of healthcare workers, patients and carers. These outcomes will be known as ‘core outcomes sets’ (COS).
First we will identify outcomes that have already been reported by conducting literature searches. We will also hold focus groups and interviews to identify outcomes which are important to patients. Next, the list of outcomes will be sent as a survey to doctors, nurses, patients and carers, asking them to rate the importance of each outcome on a scale from 1 to 9, with 1 being ‘not important’ and 9 being ‘very important’. There will be two further rounds of the survey, with each one presenting a summary of the results from the previous round. During round three, participants will be asked to state which outcomes should be included as ‘core outcomes’. A consensus meeting group will finalise the COS for dissemination.Summary of Results
Clinical trials involve research that is intended to add to medical knowledge and improve the way we treat patients. The results of a clinical trial are reported in terms of ‘outcomes’. A commonly used outcome in cancer is ‘survival’ but other outcomes such as ‘quality of life’ and ‘rates of recurrence’ are often reported.Trials are designed to ensure that enough patients are examined to produce accurate results. If a trial can examine more patients, we can be more confident in the trial’s findings. When there are many trials which look at the same condition, researchers try to put all of the results together so that they undertake an analysis with lots of participants and therefore produce a stronger and more reliable result. This method is often used when developing clinical guidelines for different diseases. Unfortunately, trials don’t always report the same outcomes and even if they do, they might measure them in different ways or at a different time. When this happens, the results cannot be combined properly and guideline recommendations must be based on less reliable evidence. If rules were developed that ensured that all trials which examine the same disease had to report the same outcomes it would be much easier to combine results and to develop guidelines. This would allow recommendations about patient care to be based on the strongest available evidence.
The aim of this project was to develop these ‘rules’ for four conditions concerned with women’s health. These were heavy periods (heavy menstrual bleeding), womb cancer (endometrial cancer), pre-cancerous thickening of the womb lining (endometrial hyperplasia) and treatments for cancer of the neck of the womb (cervical cancer) that allow a patient to still be able to be pregnant. The decision about which outcomes should always be explored were based upon the opinions of doctors, nurses, patients and carers and other people with an interest in the condition. This was very important because the set of rules needed to be relevant and important to all these involved people. The group of outcomes for each condition is known as a ‘core outcomes set’.
This project was conducted by researchers and doctors at Queen Mary University of London and Barts Health NHS trust, between February 2017 and December 2020. The work was funded by Cancer Research UK, the British Medical Association and the Academy of Medical Sciences. The lead investigator was employed as a National Institute for Health Research Academic Clinical Lecturer. None of the team had any conflicts of interest during the project.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
15/EM/0565
Date of REC Opinion
9 Dec 2015
REC opinion
Favourable Opinion