Outcomes

The centre is conducting research to improve outcome selection, measurement, reporting and integration for effective evaluation of surgical interventions and use in routine practice.

Current areas of work and projects include:

Core outcome sets (COSs)

Core outcome sets represent the minimum outcomes that should be measured and reported in all clinical trials of a specific condition. We have developed core outcome sets for multiple surgical specialties including oesophageal and colorectal cancer surgery, breast reconstruction, burn care and bariatric surgery. The centre is working with the COMET initiative to facilitate the ongoing development and implementation of COSs to maximise impact and patient benefit.

We are also developing methodology and COSs for pre-RCT (“early phase”) studies in surgery. Current work includes the COHESIVE study which aims to develop a COS and reporting guidance for new surgical procedures and devices, and the GASTROS study which aims to standardise the way outcomes are reported in research trials examining surgical treatments for gastric cancer.

Patient reported outcomes (PROs) and measures (PROMs)

The centre is working with international collaborators to improve measurement and reporting of PROs in surgical trials. This has included work with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Group to develop and validate a portfolio of PRO measures (PROMS). Other collaborations have produced the SPIRIT-PRO extension and the CONSORT-PRO extension guidelines for incorporating PROs in protocols and trial reports.

We have developed a novel approach to outcome assessment and designed a single questionnaire for completion by patients and/or healthcare professionals; universal-reporter outcome measures (UROMs). UROMs combine plain language alongside medical terminology in items, and are suitable for use when patient and healthcare views on the same subject are required. The use of plain language alongside medical terminology presents a novel technique for evaluating item interpretation and improving content validity during questionnaire development.

We have also led the development and validation of an outcome measure for surgical site infection suitable for patient or healthcare professional completion: The Bluebelle Wound Healing Questionnaire (WHQ). As part of this work, we have developed novel methods for developing measures that can be completed by patients or observers (e.g. healthcare professionals). 

Our work includes the development and testing of novel methods to blind outcome assessors, including patients, in randomised controlled trials (RCTs). The ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study has piloted methods to blind patients and outcome assessors to the type of surgery by using large adhesive dressings positioned similarly on all trial participants regardless of the type of surgery.

Electronic outcome data reporting and digital technologies

A key goal of the centre is to develop and evaluate novel methods for the digital (electronic) capture of outcomes to improve patients’ health. Projects include the development of a real-time electronic symptom reporting, monitoring and feedback system to improve patients’ recovery after discharge from hospital following cancer surgery – the eRAPID study: Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice.

The Selfi wound study is exploring the use of patient-generated digital images of surgical wounds after leaving hospital for remote and blinded assessment of surgical site infection.

MRC-NIHR Trials Methodology Research Partnership: Outcomes Working Group

The Centre contributes to the Trials Methodology Research Partnership, a novel initiative funded by the MRC-NIHR Methodology Research Programme. The TMRP brings together a number of networks, institutions and partners working in trials and trials methodology research. Researchers in the Centre lead the Outcomes Working Group of the TMRP – please contact Kerry Avery if you are interested in finding out more.


 

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