This project has been developed by Mr Hasan Asfour (ST3 trainee in General Surgery at NHS Tayside, Dundee. Honorary Fellow at the University of Leicester).

Phase 2 will be led by the Human Factors in Surgery Network (HFSN) along with the project steering committee and will utilise a trainee collaborative model for data collection. All UK and Ireland NHS Trusts/Boards in which surgical procedures are undertaken will be eligible for the study.

The study will consist of 3 phases:

Phase 1: Pilot audit study and model development (Completed)

This phase has already been completed under the regulations of the University Hospitals of Leicester NHS Trust

Phase 1A: Pilot data collection (Completed)

 A pilot survey study was conducted at the University Hospitals of Leicester NHS Trust involving 60 participants. Data were collected locally under institutional audit approval and stored in accordance with Trust data governance policies. 

The primary objectives of the pilot study were to: 

• Investigate the WRMDs prevalence among local surgeons 
• Explore gender disparities within the study population 
• Identify modifiable workplace or lifestyle risk factors 

Data from the pilot study have been analysed and submitted for publication. The pilot dataset is controlled and owned by the University Hospitals of Leicester NHS Trust. 

Phase 1B: Prediction Model Development (Completed)

Using the pilot dataset described in Phase 1A, an initial prediction model was developed and internally validated. Model training and parameter development were conducted using the Phase 1 pilot dataset. The developed prediction model constitutes a pre-existing intellectual property (IP), developed prior to initiation of the multi-centre study described in Phase 2 and is currently under review for publication.

Phase 2: Multi-centre audit and study  

This phase will be led by the Human Factors in Surgery Network (HFSN) along with the project steering committee and will utilise a trainee collaborative model for data collection. All UK and Ireland NHS Trusts/Boards in which surgical procedures are undertaken will be eligible for the study.

Phase 2A: Multi-centre data collection

A multicentre survey across the UK and Ireland will be conducted under the governance of HFSN/University of Oxford, with participating centres contributing data in accordance with HFSN/University of Oxford ethics approvals and data governance frameworks.   

The objective of the multicentre survey is to expand the pilot dataset generated in phase 1A by collecting multi-centre representative data relevant to the initial study aim.

Data collected during Phase 2 will be centrally managed by HFSN. The Phase 2 dataset is independent of the Phase 1 pilot dataset. The Steering Committee will oversee study conduct, data quality, and analysis planning in accordance with HFSN/university of Oxford governance arrangements. 

Phase 3: Validation of the prediction model using the multi-centre data 

Data collected during Phase 2 will be used for external validation of the prediction model developed in Phase 1B and will be published separately as an external validation and refinement of the model. 

Model parameters are expected to remain fixed as defined at the conclusion of Phase 1B. Use of Phase 2 data for external validation does not confer ownership, inventorship, or IP rights over the prediction model. Any future modification, retraining, or commercial development of the prediction model using multi-centre data will require separate approvals and agreements. 

Local collaborators (i.e. hospital leads) will be recruited from UK and Ireland hospitals and will be required to distribute the survey and to support data collection in their local Trust/Board.

Further information and guidance on how to obtain the above data will be provided after sign-up. The data from the checklist and survey will be analysed by the steering committee. Local collaborators will also be encouraged to audit their local checklist(s) and guidance will be provided by the steering committee.