We are developing methods to optimise the design and conduct of early and later phase evaluations of surgical and invasive procedures.

Methods to optimise trial design

The centre is leading the development of quality assurance measures to use in surgical trials, with the aim of standardising and monitoring the delivery of surgical interventions where appropriate. Within the Biomedical research centre we are also developing quality assurance measures in early phase studies. 

We have developed an initial typology and have written guidance about designing surgical interventions in RCTs. These methods were applied to the surgical interventions in the By-Band-Sleeve and ROMIO studies and are currently being expanded as part of an MRC Clinician Scientist project. 

We are also exploring key methodological considerations for developing invasive placebo interventions in surgical RCTs. We have developed the DITTO framework, which considers the design of invasive placebos systematically, accounting for risk, feasibility and placebo optimisation. Use of the framework can support the design of high-quality RCTs, needed to underpin delivery of healthcare interventions.

Our work includes the development and testing of novel methods to blind study participants, including patients, and outcome assessors 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.

Methods to optimise trial delivery

We are proud to be working with surgical trainee collaboratives to help recruit to studies and optimise trial delivery. The Sunflower study, one of the UK’s largest surgical RCTs, aims to recruit 13500 patients from 50 centres. Over 100 surgical trainees are involved, some of whom are participating in the NIHR Associate PI scheme.

We also work closely with the Qualitative Research Integrated within Trials (QuinteT) group to develop methods to overcome challenges and optimise recruitment into trials that involve surgery. The QuinteT Recruitment Intervention (QRI) aims to understand and optimise recruitment and has been integrated into over thirty nationally funded feasibility, pilot and full RCTs. We are also using these novel qualitative methods, such as recording interactions between patients and healthcare professionals, to understand how new surgical procedures are introduced in the Surgical Innovation workstream on ‘Informed consent for new and evolving surgeries’ within the NIHR Bristol Biomedical Research Centre.

Methods to optimise trial outcome assessment

We are developing electronic data capture methods for use in surgical trials, with a specific focus on patient-reported outcomes. The eRAPID study.

Ongoing work is exploring the use of patient-generated digital images of wounds for remote, blinded outcome assessment of surgical site infection. Initial feasibility and acceptability of the method has been examined in the Selfi wound study

The centre is also working with international collaborators to improve measurement and reporting of patient reported outcomes (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 several PROs and 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 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). 

 

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