Single Cohort Before and After Mixed-methods Prospective Study to Investigate the Impact of the Salutare One Referral Software on Patient Outcomes, Safety and Effectiveness of Multi-Disciplinary Team (MDT) Meetings
Phase: NA
Conditions: Cancer (Solid Tumors), Sarcoma
Sponsor: Salutare Group Ltd.

 Salutare Dialogue for MDTs 
 
CONFIDENTIAL
 
 
 
Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 0 of 32 
 
 
 
 
 
Salutare One Referral for MDTs 
Single cohort before and after mixed-methods prospective study to 
investigate the impact of the Salutare One Referral software on patient 
outcomes, safety and effectiveness of Multi-Disciplinary Team (MDT) 
meetings    
PROTOCOL 
Version 2  (22/01/2025) 
Chief Investigator:  
Prof Kevin Moore, Salutare  
Co-Investigators: 
 
 
Dr Ameet Bakhai, Salutare, Royal Free  
Dr Dara Vakili, Salutare  
Dr Rachel Baumber, RNOH 
Mr Reza Mirnezami, Royal Free 
Liba Stones, DiCro 
Sponsor:  
 
 
Salutare Group Ltd.  
This protocol is a controlled confidential document and should not be copied, distributed, or reproduced without 
the written permission of the Sponsor. This study has been approved by the Chief Investigator and the Health 
Research Authority (HRA) 
 
  

 Salutare Dialogue for MDTs 
 
CONFIDENTIAL
 
 
 
Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 1 of 32 
 
Chief Investigator 
Prof Kevin Moore 
Medical Director,  
Salutare Group Ltd., 1110 Elliott Court Coventry Business Park, Herald Avenue, Coventry, West Midlands, United 
Kingdom, CV5 6UB 
Consultant Hepatologist, Professor of Hepatology, Royal Free London NHS Foundation Trust, University College 
London 
kevin@salutare.co.uk  
http://www.salutare.co.uk 
Co-Investigators 
Dr Ameet Bakhai 
Clinical Safety Officer, Lead Statistician 
Consultant Cardiologist (Royal Free London NHS 
Foundation Trust)  
ameet@salutare.co.uk  
http://www.salutare.co.uk  
Dr Dara Vakili 
Product Manager, Study Manager 
FY1 Doctor, Princess Alexandra Hospital NHS Trust 
Salutare Group Ltd. 
1110 Elliott Court Coventry Business Park, Herald 
Avenue, Coventry, West Midlands, United Kingdom, 
CV5 6UB 
Dara@salutare.co.uk  
 
Dr Rachel Baumber 
Consultant Anaesthesiologist  
Royal National Orthopaedic Hospital  
Brockley Hill, Stanmore,  
Middlesex, HA7 4LP 
Email: rachel.baumber@nhs.net  
 
Liba Stones, MA, MBA  
DiCro 
Director 
20 Wenlock Road 
London, N17GU 
liba@dicro.co.uk 
liba.stones1@nhs.net 
http://www.dicro.co.uk  
 
Sponsor organisation:  
Sponsor:   
Salutare Group Ltd.  
1110 Elliott Court Coventry Business Park, Herald 
Avenue, Coventry, West Midlands, United Kingdom, 
CV5 6UB 
Sponsor representative  
Prof Kevin Moore 
Salutare Group Ltd., 1110 Elliott Court Coventry Business 
Park, Herald Avenue, Coventry, West Midlands, United 
Kingdom, CV5 6UB 
kevin@salutare.co.uk  
http://www.salutare.co.uk 
 
 
 
 

 Salutare Dialogue for MDTs 
 
CONFIDENTIAL
 
 
 
Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 2 of 32 
 
Host Institution: Royal National Orthopaedic Hospital,  
Lead R&D contact:  
Nnebuife Oji 
Acting Head of R&D 
Royal National Orthopaedic Hospital  
Brockley Hill, Stanmore,  
Middlesex, HA7 4LP 
Principal Investigator (RNOH)  
Dr Rachel Baumber 
Consultant Anaesthesiologist  
Royal National Orthopaedic Hospital  
Brockley Hill, Stanmore,  
Middlesex, HA7 4LP 
Email: rachel.baumber@nhs.net 
Principal Investigator (Royal Free, Colorectal Cancer 
MDT)  
Mr Reza Mirnezami 
Consultant in Colorectal, General and Emergency 
Surgery 
Royal Free London NHS Foundation Trust  
Pond Street  
London, NW3 2QG 
Email: reza.mirnezami@nhs.net   
 
Investigator (Royal Free, Breast Cancer MDT)  
Mr Muneer Ahmed 
Consultant in Breast Surgery 
Royal Free London NHS Foundation Trust  
Pond Street  
London, NW3 2QG 
Email: muneer.ahmed@nhs.net   
 
 
Any questions relating to this protocol should be addressed to:  
Kevin Moore, Sponsor Representative 
kevin@salutare.co.uk    
Salutare Group Ltd.  
Address:  
1110 Elliott Court Coventry Business Park, Herald Avenue, Coventry, West Midlands, United Kingdom, CV5 6UB 
Protocol Authorised by: 
Name & Role:  
Signature:  
Date:  
 
Prof Kevin Moore (Chief Investigator) 
 
 
Prof Kevin Moore  
 
22/01/2025 
 
 
 
 

 Salutare Dialogue for MDTs 
 
CONFIDENTIAL
 
 
 
Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 3 of 32 
 
TABLE OF CONTENTS 
1. 
Summary of Study Design 
5 
2. 
Background and rationale 
8 
2.1. 
Salutare One Referral 
8 
3. 
The problem 
9 
4. 
User Involvement 
10 
5. 
One Referral safety and performance testing 
10 
5.1. 
Functional, integration, and performance testing 
10 
5.2. 
User Acceptance Testing (UAT) 
10 
5.3. 
Beta Testing 
11 
6. 
Study rationale 
12 
7. 
Objectives 
13 
7.2 Primary objective 
13 
7.3 Secondary objectives 
13 
8. 
Study Design 
14 
8.1 
Primary Endpoint 
14 
8.2 
Secondary endpoints 
14 
8.3 
The Study Evaluation Model 
15 
8.4 
Risk Scores 
16 
8.5 
Statistical Analysis 
17 
8.6 
Expected Outcomes 
18 
8.7 
Study Group 
18 
8.8 
Inclusion criteria 
18 
8.9 
Exclusion criteria 
18 
9. 
Approaching participants to join the study 
18 
10. Study Phases 
19 
10.1. 
Pre-intervention phase 
19 
10.2. 
Onboarding phase 
19 
10.3. 
Intervention phase 
19 
10.4. 
Post intervention phase 
20 
11. Study Assessments 
20 
11.1 Baseline Assessment 
20 
11.2 
Onboarding Assessment 
20 

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Title: Salutare Dialogue for MDTs 
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11.3 
Intervention Assessment 
20 
11.4 
Post-Study Assessment 
21 
12. Data collection from One Referral 
21 
13. Schedule of interventions and assessments 
22 
14. Study duration 
23 
15. Early Discontinuation/Withdrawal of Participants 
23 
16 
Legal and Regulatory Requirements 
24 
16.1 
NICE and DH requirements for Digital Health Technologies 
24 
16.2 
Clinical safety 
25 
16.3 
Study risk management 
25 
16.4 
Adverse Event monitoring 
26 
16.5 
Incident reporting 
27 
16.6 
Confidentiality 
27 
16.7 
Cybersecurity 
28 
16.8 
Medical Device Regulations 
28 
16.9 
Ethical compliance 
28 
17. Quality Assurance Procedures 
29 
17.1 
Study Monitoring 
29 
17.2 
Protocol Deviations 
29 
18. Payments and incentives 
29 
19. Funding 
29 
20. Indemnity 
29 
21. Intellectual Property 
29 
22. Presentation and publication plans 
30 
23. End of Study 
30 
References 
31 
 
 
 
 

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 5 of 32 
 
1. Summary of Study Design 
Title 
Single cohort before and after mixed-methods prospective study to investigate 
the impact of the Salutare One Referral software on patient outcomes, safety 
and effectiveness of Multi-Disciplinary Team (MDT) meetings 
Short Title/acronym 
Salutare One Referral for MDTs   
IRAS number 
347710 
Sponsor  
Salutare Group Ltd. 
Funder name & reference 
Salutare Group Ltd. 
Clinicaltrials.gov no 
TBC
 
 
Design 
A mixed-methods prospective Before and After Study 
Primary objective  
The primary objective is to evaluate safety, acceptability and implementation 
feasibility of the Salutare One Referral Software 
Secondary objectives 
Determination of the following metrics with and without the use of the Salutare 
One Referral software: 
 
(1) MDT administration time 
(2) Completeness of pre-assessment information  
(3) Clinical engagement 
(4) Time spent by MDT panel members attending meetings 
(5) MDT performance rating 
(6) Duration of MDT per-patient discussion time 
(7) Overall time for MDT meetings 
(8) Time from referral submission to the generation of MDT definitive 
decisions.  
(9) Time from referral submission to the implementation of MDT 
recommendations (OPTIONAL) 
(10) Number and rate of cases re-presented for MDT review – breast cancer 
only 
(11) Drug changes to accommodate surgery or any disease optimisation 
advice 
(12) Presence or absence of  peri-operative and post-operative 
complications (OPTIONAL) 
 
 
Primary endpoint 
The study aims to assess the Salutare One Referral Software's safety, 
implementation feasibility and users acceptability in facilitating effective MDT 
meetings. System Usability Score (SUS) and user questionnaires will be 
administered to MDT panel members, with modifications to the SUS as 
necessary. The primary and secondary endpoints of the study will inform future 

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
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protocol amendments and expansion to additional sites. This will enable the 
selection of suitable endpoints most relevant to the patient pathway and care 
outcomes, such as the “time from referral to recommendation 
implementation”.  
Secondary endpoints 
 
Measure 
Assessed via 
(1) MDT administration time 
Participant questionnaire 
MDT meetings observation dataset 
(2) Completeness of pre-
assessment information 
• 
Medical history Risk score 
completion 
• 
TNM recording (radiological 
and pathological) - breast 
cancer only 
 
Participant questionnaire 
MDT meetings observation dataset 
Note: If access to the patient’s 
medical record is required, for 
example if any aspects of the pre-
assessment information are missing 
in the forms, the data would be 
provided by a member of the direct 
care team.  
(3) Clinical engagement  
 
Participant questionnaire  
MDT meetings observation dataset  
(4) Time spent by MDT panel 
members attending meetings 
Participant questionnaire  
MDT meetings observation dataset 
 
(5) MDT performance rating 
Participant questionnaire  
(6) Duration of MDT per-patient 
discussion time 
MDT meetings observation dataset 
 
(7) Overall time for MDT 
meetings 
Participant questionnaire  
MDT meetings observation dataset 
 
(8) Time from referral to the 
generation of MDT 
recommendation 
MDT meetings observation dataset 
Note: If access to the patient’s 
medical record is require, for example 
if the MDT recommendation date is 
not clear in the forms, the data would 
be provided by a member of the 
direct care team.  
(9) Time from referral to the 
implementation of MDT 
recommendations 
(OPTIONAL) 
• 
“Decision to Treat” 
(cancer MDT) 
• 
Date of operation 
(Anaesthetics) 
MDT meetings observation dataset 
Participant questionnaire 
Note: If access to the patient’s 
medical record is required, for 
example if any aspects of the pre-
assessment information are missing 
in the forms, the data would be 
provided by a member of the direct 
care team.  
(10) Number and rate of cases re-
presented for MDT review – 
breast cancer only  
MDT meetings observation dataset 

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
22/01/2025 
Page 7 of 32 
 
(11) Drug changes to 
accommodate surgery or any 
disease optimisation advice. 
 
MDT meetings observation dataset 
 
(12) Presence or absence of peri-
operative and immediate 
post-operative complications 
(OPTIONAL) 
Medical records to be reviewed by a 
member of the NHS direct care team  
Target  
RNOH Anaesthetic MDT: Approximately 20 staff taking part in MDT 
meeting  taking part in the MDT meeting preparation and discussion. We 
aim to collect data for approximately 40 cases discussed without the 
Salutare One Referral software and approximately 40 patients discussed 
with Salutare One Referral.  
Royal Free (Colorectal Cancer):  Approximately 20 staff taking part in MDT 
meeting  taking part in the MDT meeting preparation and discussion. We 
aim to collect data for approximately 120 cases discussed without the 
Salutare One Referral software and approximately 120 cases discussed 
with Salutare One Referral. 
Royal Free (Breast Cancer): Approximately 50 staff taking part in the MDT 
meeting preparation and discussion. We aim to collect data for 
approximately 150 cases discussed without the Salutare One Referral 
software and 150 patients discussed with Salutare One Referral. (Note: The 
Royal Free Breast Cancer MDT testing is currently on hold, subject further 
discussions).  
Inclusion criteria (Active 
Study Group) 
MDT meeting Panel Members, Coordinators and staff submitting MDT 
referrals will take part in this study.  
Exclusion criteria (Main 
study) 
MDT meeting Panel Members, Coordinators and staff submitting MDT 
referrals who are unwilling or unable to take part in the study. 
Duration of study  
The study consists of 4 phases:  
1. Pre-intervention period (before-study control) with no access to 
the Salutare One Referral software.  
2. Onboarding period to allow for software installation and staff 
training and adjustment to the technology  
3. Salutare One Referral intervention period  
4. Post-intervention period (after-study control) with no access to the 
Salutare One Referral software 
The total duration of the study will depend on the frequency of MDT 
meetings and the number of cases discussed.  

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
Authors  
K Moore, A Bakhai, L Stones 
Ver.2 
 
Date Authorised 
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2. Background and rationale  
2.1. Salutare One Referral 
The One Referral product from Salutare Group Ltd is a cloud-based, patient-centred multi-disciplinary team 
(MDT) meeting application designed to facilitate,  standardise and partially automate the referral and review of 
patient cases. Salutare Group Ltd is a UK-based software company. 
The primary objective of One Referral is to simplify and standardize the referral process to hospital or 
community-based MDTs, aiming to enhance patient safety, efficiency, and the effectiveness of MDT discussions. 
It achieves this by providing all panel members with essential information necessary for discussing and 
contributing to MDT clinical decision-making, thereby replacing paper or email-based referrals with a fail-safe 
system that enables tracking of patient pathways. 
Moreover, One Referral facilitates and partially automates the uploading of patient medical history, including 
laboratory and radiology examinations, distributing this information to MDT panel members. Additionally, One 
Referral has the capability to access the Summary Care Record via the Spine. 
The platform features a comprehensive dashboard that provides a summary of MDT review outcomes and 
recommendations/actions, such as requests for further medical information. Completed and reviewed referrals 
can be exported as PDF documents, which are compatible with Electronic Patient Record (EPR) systems. 
Future plans for One Referral include the development of a patient engagement module. This module will enable 
the collection of patient feedback and background clinical data, while also keeping patients informed about the 
progress and outcomes of MDT reviews.  
• 
Stanmore Anaesthetics MDT and Royal Free Colorectal Cancer 
MDT: The study duration will be approximately 18 weeks (4-week 
pre-intervention period, 2-week onboarding period, 8-week 
intervention period, 4-week post-intervention period)  
• 
Royal Free Breast Cancer MDT: The study duration will be 
approximately 10 weeks (2-week pre-intervention period, 2-week 
onboarding period, 4-week intervention period, and a 2-week 
post-intervention period).  
Additionally, 4 weeks are allowed to complete the study data collection.  
Definition of the start of 
the study  
Following the issue of the HRA approval and the Trust Capacity & Capability 
approval, the study data collection with start by distributing surveys to the 
MDT panel members.  
Definition of end of study 
The study will end when the last study participant returns the last study 
questionnaire.  

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
Authors  
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Ver.2 
 
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3. The problem  
MDTs aim to improve treatment standards by ensuring that all patients receive considered and homogeneous 
treatment and care from appropriately skilled professionals. MDTs are widely used in the UK health sector and 
recognised at a policy level as the preferred means of delivering complex care for chronic as well as acute 
diseases (Chinai et al., 2013; Maharaj et al., 2021; Raine et al., 2014). The widespread implementation of MDTs in 
the UK dates back to the early 1990s when the MDT model was recommended as a standard model to improve 
cancer care, following the publication of the EUROCARE study which demonstrated poorer survival in the UK than 
in other European countries for most types of cancer (Chinai et al., 2013).  
However, there remains a significant diversity in the purpose, structure, processes and content of MDT meetings, 
and the degree to which they have been absorbed into clinical practice (Chinai et al., 2013; Maharaj et al., 2021; 
Raine et al., 2014). Issues commonly observed include deferring discussions due to incomplete medical history, 
re-discussing the same cases due to inadequate recording of previous discussions, and failure to systematically 
manage cases to meet local and national targets, such as the RTT deadlines. 
Raine et al. (2014) undertook a mixed-methods prospective observational study of 12 MDTs in the London and 
North Thames area to identify the key characteristics MDT meetings that are associated with “decision 
implementation”, a measure of effectiveness, and made recommendations in three key areas, which expert 
stakeholders from a range of chronic disease specialties agreed were both desirable and feasible. These related to 
the purpose of the meetings (e.g. that agreeing treatment plans should take precedence over other objectives); 
meeting processes (e.g. that MDT decision implementation should be audited annually); content of the discussion 
(e.g. that information on comorbidities and past medical history should be routinely available); and the role of the 
patient (e.g. concerning the most appropriate time to discuss treatment options). Given the core function of 
MDTs, Raine called for further research experimentally evaluating their effectiveness in a pragmatic controlled 
trial, with focus on examining the association between MDT decision implementation and improvements in 
patient outcomes. 
Research shows ICT is improving clinical processes by supporting data-driven care and allows patient outcomes to 
be measured and compared to benchmark performance metrics. The use of health information systems and 
technology are key enabling factors for building the capacity of MDTs to engage in improvement and 
implementation projects but there is scant research on how MDTs make use of technology and information 
systems or the kinds of systems needed (Janssen et al., 2018). Janssen et al. (2018) found that technology was 
most frequently used to display patient imaging, followed by videoconferencing. To our knowledge, there is no 
prospective research the impact of a decision-support system on MDT effectiveness and patient care outcomes.  
Patient communication breakdowns account for 13.2% of complaints in primary and 16.6% in secondary care 
(NHSE, 2023). A recent ground-breaking nation-wide research conducted by the Demos & Patient’s Association 
(2023) reported that 17% patients believe their referrals have been lost and 26% chase up referrals for timely 
attention (Patient Association, 2023). Globally, clinical communication breakdowns are a leading cause of medical 
errors (NIH, 2008), implicated as the root cause of >70% of sentinel events (Joint Commission, 2005). 
Munro et al. (Munro et al., 2015) examined the impact of multidisciplinary team (MDT) processes on colorectal 
cancer outcomes. They found that MDT recommendations were implemented in 70.1% of patients (MDT+), with a 
5-year survival rate of 63.1%, compared to 48.2% in the 29.9% of patients who were not discussed or without 

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
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implemented recommendations (MDT-) (p < 0.0001). The adjusted hazard rate for death was 0.73 (p = 0.047) for 
MDT+ patients, indicating a survival benefit, especially in those with advanced disease (adjusted HR 0.65, 
p = 0.031). 
4. User Involvement 
The Salutare One Referral software was designed and developed by a cross-functional team with expertise in 
systems’ architecture, design, programming, with input from clinicians experienced in MDT meeting operations. 
The software was tested systematically throughout the development phases to provide assurance of compliance 
with design specification, performance criteria and industry standards. The following describes the levels of testing 
which have been completed.   
5. One Referral safety and performance testing 
5.1. Functional, integration, and performance testing 
Functional, integration, and performance testing will be completed by Salutare clinical and engineering staff and 
clinical reviewers.  Functional testing is performed to validate all functionalities of the software in line with the 
agreed design specification. Integration testing is performed to validate interaction across the system modules to 
verify that they work well when compiled. Performance testing is completed to ensure the system meets the 
expected standards in relation to speed and stability prior to deployment for UAT, beta testing, and study feasibility 
testing. These steps are performed to ensure the production environment that will run the software behaves 
accordingly and will be completed when the environment is live.  
5.2. User Acceptance Testing (UAT)  
User Acceptance Testing (UAT) is a type of testing performed by the end user or the client to verify and approve 
the software system before moving the software application to the production environment. A comprehensive 
UAT, encompassing all aspects and features of the system as detailed in the UAT Test Plan, will be completed 8 
weeks before deployment by Salutare internal reviewers – specifically the software technical managers, head of 
product, head of operations, and clinical reviewers. This UAT is conducted in the Salutare Azure demo environment, 
which mirrors the production environment but uses test patient data.  
Following a successful internal UAT, the software undergoes an additional UAT review with end users 6 weeks 
before the anticipated deployment. The UAT testing scenarios include tasks such as sending a referral, tracking its 
changes, receiving a referral as an MDT after set-up, and finalising the referral from both sides. 
During UAT, data on the usability and performance of the software is collected and documented for test evaluation. 
The criteria for passing UAT are based on the following evaluation matrix: 
Criteria 
Sub-Criteria 
Evaluation Metric 
Functionality 
All test scenarios must pass without critical 
errors 
0 critical errors encountered 
 
All test cases passed  
Usability 
User friendly interface 
User feedback on ease of use 

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Title: Salutare Dialogue for MDTs 
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Intuitive navigation 
 
Clear error messages 
 
Time taken to complete key tasks 
 
Clarity and helpfulness of error messages 
Performance 
System response time 
 
System stability 
Average response time under typical load 
 
Number of crashes or performance issues 
Security 
Data protection 
 
Access controls enforced 
Encryption standards compliance 
 
Audit of access control mechanisms 
 
Number of security incidents 
 
Any defects identified during testing are logged with detailed descriptions and steps to reproduce. These defects 
are then reviewed and confirmed by a product owner before being prioritised and resolved by the development 
team. Retesting is conducted to verify the fixes.  
All UAT findings are risk-assessed for their impact on system safety, performance, functionality and cybersecurity. 
Issues with potential adverse impacts are addressed and rectified before deployment for beta testing.  
UAT is considered complete when all high-priority defects are resolved and the system meets the acceptance 
criteria. This process requires sign-off from the software technical managers, head of product, head of operations, 
and clinical reviewers.  
Testing documentation is jointly managed by the Salutare head of operations and the head of product. All UAT 
protocol documentation and result recordings are stored on Confluence, a specialised documentation software for 
software development.  
5.3. Beta Testing   
Beta Testing is an external UAT acceptance testing completed by the intended end-users to validate the product's 
functionality, usability, reliability, and compatibility. This phase is crucial as it provides real-world exposure and 
feedback from a broader user base. 
Beta testing by MDT panel members will be conducted following the successful completion of UAT to the same 
standards previously implemented for internal UAT. The aim is to uncover any issues that may not have been 
evident during internal testing, ensuring the software performs optimally in diverse environments and use cases.  
Beta Testing is deemed complete when the software meets the acceptance criteria, demonstrating it is ready for 
deployment. Sign-off is required from the software technical managers, head of product, head of operations, and 
clinical reviewers before moving to the production environment. All beta testing documentation is maintained on 
Confluence for future reference and compliance. 
Dr Dara Vakili, Study Investigator and Salutare Product Manager, will meet with the MDT chair and Principal 
Investigator and MDT Coordinator (if applicable) to identify 3-5 MDT panel members to complete the site beta 
testing. They will all individually run the beta testing protocol and answer a form based on criteria as specified in 
section 5.2. The form will be hosted on NHS SharePoint so that all stakeholders can access it to assess the software. 

 Salutare Dialogue for MDTs 
 
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Title: Salutare Dialogue for MDTs 
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This also means that all corrections will be captured and amalgamated into a single form the product manager can 
hand over to software engineers for fixes.  
6. Study rationale 
This study aims to assess the feasibility and potential benefits of leveraging the Salutare One Referral software to 
facilitate, standardize, and partially automate the referral and review of patient cases within the MDT framework. 
The software offers a promising solution by providing a platform for recording pre-assessment information, thereby 
replacing manual forms and streamlining data entry. Additionally, it has the potential to integrate with the 
Summary Care Record, partially populating the pre-assessment dataset and further enhancing efficiency while 
reducing time spent on list management and administrative tasks. 
The One Referral software will streamline the process of requesting and recording inputs from MDT team members, 
saving significant administrative time and improving collaboration. Furthermore, it can be configured to calculate 
pre-operative risk scores by integrating commonly used risk algorithms to aid in informed decision-making during 
MDT discussions, contributing to patient safety and optimizing treatment plans. 
The study will be conducted at the Royal National Orthopaedic Hospital Trust (RNOH) Orthopaedic MDT and the 
Royal Free London NHS Foundation Trust (RFL) Breast Cancer MDT. The choice of these two sites allows for an 
evaluation of the Salutare One Referral software in two different contexts: 
• 
Complex case review (RNOH Anaesthetics MDT, Royal Free Colorectal Cancer MDT): This setting will test 
One Referral's ability to handle and present detailed, multifaceted patient information effectively. 
• 
High caseload review (RFL Breast Cancer MDT): The RFL Breast Cancer MDT manages a high volume of cases 
as part of a standardized cancer pathway. This setting will evaluate One Referral's efficiency in streamlining 
discussions for a larger number of patients per meeting. (Note: The Royal Free Breast Cancer MDT testing 
is currently on hold, subject further discussions). 
By including both complex and high-volume case reviews, we aim to assess the versatility and adaptability of the 
Salutare One Referral software across different MDT structures, workflows, and patient populations. This approach 
will provide valuable insights into the software's potential benefits and challenges in varied clinical contexts, 
enhancing the generalizability of our findings. The study might be amended following the first phases of tested and 
expanded to MDTs in other clinical pathways and therapy areas.  
RNOH Orthopaedic MDT  
The RNOH Orthopaedic MDT meets every two weeks, with approximately 10-11 participants, including 
Anaesthetists, General Physicians, Medical Consultants, Rehabilitation Specialists, Cardiologists, and as needed, 
Orthopaedic Surgeons, Pharmacists, Haematologists and Radiologists. The MDT is chaired by Dr Rachel Baumber, 
Consultant Anaesthetist, the study Principal Investigator. The MDT focuses on discussing complex surgery cases 
referred by Consultant Anaesthetists, primarily for cancer (e.g. sarcoma) and cardiovascular disease. Each case 
undergoes team discussion facilitated by a pre-assessment document. 
At present, the MDT operates without specialised software, relying on completed documents uploaded to a Shared 
Drive. Typically, Consultants submitting referrals will circulate a Power Point slide deck, explaining the case being 
reviewed. A standard form is also completed and submitted. Administrative responsibilities are shared between a 

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Registrar and the MDT Chair due to the absence of an MDT administrator. A notable time-consuming task involves 
soliciting comments from various specialists, such as Cardiologists, to ensure thorough evaluation of the patient. 
The MDT typically addresses a maximum of 10 complex cases per session. Approximately 20% of cases necessitate 
re-presentation due to missing critical information, such as comorbidities and medication, resulting in delays in 
patient pre-operative pathways. 
Royal Free Colorectal Cancer MDT  
The Royal Free Colorectal Cancer MDT convenes weekly, reviewing approximately 30 cases. The team comprises 
MDT Coordinators, Colorectal Surgeons, Oncologists, Radiologists, Pathologists and Clinical Nurse Specialists. The 
MDT focuses on discussing complex colorectal cancer cases and findings from surgical procedures, with 
approximately 50% of cases presented post-surgery. Each case discussion averages 10 minutes, with surgeons 
typically attending in person. Case submissions are managed through a combined effort between MDT 
Coordinators and Surgeons. 
At present, the MDT operates using paper-based documentation. Cases are recorded on standardized forms, with 
referrals managed jointly by Consultants and the MDT Coordinator. Cases require comprehensive documentation 
of imaging, pathology, and clinical findings to enable effective team discussion and treatment planning. 
Royal Free Breast Cancer MDT 
The Royal Free  Breast Cancer MDT meets once per week discussing approximately 90 breast cancer cases, of which 
there are 60 new cases and 30 roll over cases (cases brought back due to insufficient information).  The team 
comprises MDT Coordinators, Breast Surgeons, Oncologists, Radiologists, Pathologists and Senior Nurse Specialists. 
The MDT focuses on discussing all breast cancer cases in the breast cancer treatment pathway. Each case undergoes 
team discussion of cases referred following triple assessment or other pathways. The MDT involvement in this study 
will be led by the Breast Service Clinical Lead, Dr Muneer Ahmed, Consultant Breast Surgical Oncologist and 
Reconstructive Surgeon.   
At present, the MDT operates without specialised software. Typically, Consultants submit referrals to the MDT 
Coordinator who lists the cases, and the history is presented verbally with minimal information (name, site of lesion, 
and essential facts) listed in a single short paragraph.  The list typically contains the information for 10 patients on 
a single side of A4 and is printed and discussed freehand.   Approximately 30% of new cases need re-presentation 
due to missing critical information, resulting in delays in patient pre-operative pathways. 
7. Objectives  
7.2 Primary objective 
The primary objective is to evaluate safety, acceptability and implementation feasibility of the Salutare One 
Referral Software. 
7.3 Secondary objectives 
Determination of the following metrics with and without the use of the Salutare One Referral software: 
 

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(11) Drug changes to accommodate surgery or any disease optimisation advice 
(12) Presence or absence of peri-operative and post-operative complications (OPTIONAL) 
 
8. Study Design  
The study is designed as a mixed-methods prospective Before and After Study.  
8.1 
Primary Endpoint  
The determination of the Salutare One Referral Software safety, implementation feasibility and user acceptability 
in facilitating effective MDT meetings.  One Referral software System Usability Score (SUS) and user 
questionnaires will be administered to MDT panel members. The intent is to utilise the current study’s primary 
endpoint to inform a future protocol amendment and study expansion to further sites to test for clinically 
relevant and patient relevant outcomes.  
8.2 
Secondary endpoints  
Determination of the following metrics with and without the use of the Salutare One Referral software: 
Measure 
Assessed via 
(1) MDT administration  time 
Participant questionnaire 
MDT meetings observation dataset  
(2) Completeness of pre-
assessment information 
• 
Medical history 
• 
Risk score 
completion 
• 
TNM recording 
(radiological and 
pathological) – 
breast cancer only  
Participant questionnaire 
MDT meetings observation dataset 
Note: If access to the patient’s medical record is required, for example 
if any aspects of the pre-assessment information are missing in the 
forms, the data would be provided by a member of the direct care 
team. 
(3) Clinical engagement  
 
Participant questionnaire  
MDT meetings observation dataset 
(4) Time spent by MDT panel 
members attending meetings 
Participant questionnaire  
MDT meetings observation dataset 
 
(5) MDT performance rating 
Participant questionnaire 
(1) MDT administration time 
(2) Completeness of pre-assessment information 
(3) Clinical engagement 
(4) Time spent by MDT panel members attending meetings 
(5) MDT performance rating 
(6) Duration of MDT per-patient discussion time 
(7) Overall time for MDT meetings 
(8) Time from referral submission to the generation of MDT definitive decisions.  
(9) Time from referral submission to the implementation of MDT recommendations (OPTIONAL) 
(10) Number and rate of cases re-presented for MDT review – breast cancer only 

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(6) Duration of MDT per-patient 
discussion time 
Participant questionnaire  
MDT meetings observation dataset 
 
(7) Overall time for MDT 
meetings 
Participant questionnaire 
MDT meetings observation dataset 
 
(8) Time from referral to the 
generation of MDT 
recommendation 
MDT meetings observation dataset 
Note: If access to the patient’s medical record is require, for example 
if the MDT recommendation date is not clear in the forms, the data 
would be provided by a member of the direct care team.  
(9) Time from referral to the 
implementation of MDT 
recommendations 
(OPTIONAL) 
• 
“Decision to Treat” 
(cancer MDT) 
• 
Date of operation 
(Anaesthetics) 
MDT meetings observation dataset 
Participant questionnaire 
Note: If access to the patient’s medical record is required, for example 
if any aspects of the pre-assessment information are missing in the 
forms, the data would be provided by a member of the direct care 
team. 
(10) Number and rate of cases re-
presented for MDT review – 
breast cancer only 
MDT meetings observation dataset 
MDT meetings recordings 
MDT referral form (local form or Salutare One Referral form – PDF 
extract) 
(11) Drug changes to 
accommodate surgery or any 
disease optimisation advice. 
MDT meetings observation dataset 
 
(12) Presence or absence of peri-
operative and immediate 
post-operative complications  
Medical records to be reviewed by a member of the NHS direct care 
team 
 
8.3 
The Study Evaluation Model 
A Logic Model is used as a theory-based approach to explicitly articulate the underlying theory of change which 
shapes the desired outcomes and impacts achieved by the Salutare One Referral software as per the study 
hypothesis (Kaplan and Garrett, 2005; Hayes et al., 2011; Helitzer et al., 2010, Friedman & Wyatt 2006).  

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Figure 1: One Referral Logic Model 
The chosen secondary endpoints are the observed clinical outputs. The study is a pilot project and therefore not 
powered to collect data on health outcomes mediated by the clinical outputs. Note: The patient communication 
module is currently not yet available and therefore will not be assessed in the present study. Observing the duration 
of MDT per-patient discussion time with and without One Referral contributes to understanding the software's 
influence on MDT efficiency. This endpoint sheds light on whether One Referral facilitates more concise and 
productive discussions among team members. 
User questionnaires assessing MDT discussions' effectiveness and referral information completeness with and 
without One Referral provide further qualitative data on the software's impact. Lastly, evaluating MDT preparation 
time through user questionnaires offers insights into the software's efficiency in streamlining preparatory tasks. 
The System Usability Score (SUS) (Brooke, 1996), the only validated tool used in this study, offers valuable insights 
into the acceptability of the One Referral software. SUS is a simple, widely used 10-statement survey that asks users 
to rate their level of agreement or disagreement to the 10 statements (half worded positively, half worded 
negatively) about the software under review.  
Usability research within the human-computer interaction field shows that user scores differ substantially over 
time, with users reporting more favourable scores as they expand their experience with the product (Mendoza and 
Novick, 2005; McLellan, 2012). Repeated observations of a group of users over time are recommended in order to 
follow up changes with respect to one or more evaluation variables., with initial use evaluation affording insights 
on ‘discoverability’ or ‘learnability’ and further evaluations elucidating true usability experiences. 
8.4 
Risk Scores 
Breast Risk Scores 

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PREDICT (Wishart GC et al, 2010) is a risk score that shows how different treatments for early invasive breast 
cancer might improve survival rates after surgery. It is widely used in breast cancer MDTs and by the Royal Free 
Breast Cancer team. It is an important clinical decision-making factor for the MDT outcomes and its completion 
rate in referrals before and after the implementation of One Referral software will be assessed.  
Anaesthetic risk scores  
The ASA (American Society of Anesthesiologists) Physical Status Classification System (ASA. 2024) is a tool used to 
assess peri-operative risks for surgical patients. This system categorises patients into six classes based on their 
preoperative health status, ranging from ASA I (healthy) to ASA VI (brain-dead organ donor).  
The SORT is a tool designed to predict the risk of death within 30 days after inpatient surgery. Developed through 
a collaboration between NCEPOD researchers (Protopapa and Smith, 2014) and clinicians at the UCL/UCLH 
Surgical Outcomes Research Centre, the SORT model has undergone various evaluations in different patient 
groups and contexts since its initial release. It is recommended to use this model, incorporating clinical estimates 
from senior decision-makers and, ideally, the input of a multidisciplinary team. 
In this study, the ASA Physical Status Classification System and SORT scores will be employed to evaluate patients' 
peri-operative risk profiles. The presence or absence of the scores in the pre-assessment documentation will be 
evaluated as one of the key indicators of the pre-assessment information completeness.  
8.5 
Statistical Analysis  
This study will employ a descriptive approach to analyse the collected data. Prior to finalising the statistical 
approach, the distribution of key variables will be assessed. In cases where variables show significant skewness, 
data transformation techniques, such as logarithmic transformation, will be considered to improve normality.  
Patient records discussed by the MDT panels will be reviewed and analysed. For the complex case MDTs (RNOH 
Anaesthetics MDT and Royal Free Colorectal Cancer MDT), all cases discussed during the study pre-intervention, 
intervention and post-intervention phases will be included in the study analysis.  
For the high-volume MDTs (Royal Free Breast Cancer MD), approximately 25% cases are expected to be 
submitted using Salutare One Referral during the intervention period. A formal comparison of the pre-
intervention and intervention study cohort will be made. At the end of the study, raw data will be processed for 
summary and descriptive statistics. The distribution of times from referral to MDT decision & implementation will 
be assessed to check if mean or median most appropriate to use.  
Normally distributed data will be reported as means with 95% confidence intervals (CIs), while non-normally 
distributed data will be presented as medians with interquartile ranges (IQRs). Categorical variables will be 
summarized using proportions or percentages, accompanied by their corresponding 95% CIs.  
Pending normality testing using the Kolmogorov-Smirnov Test, a combination of Multivariate Mixed-Effects Models 
and Generalized Linear Mixed Models (GLMMs), the latter for categorical, ordinal, and binary measures, will be 
carried out for comparing the system usability scales the acceptance of the null hypothesis.   

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8.6 
Expected Outcomes  
The implementation of the Salutare One Referral Software is anticipated to enhance operational efficiencies by 
improving the quality of pre-assessment information and reducing the time spent preparing for meetings. These 
enhancements are expected to result in a higher percentage of patients receiving definitive MDT decisions, 
thereby shortening the patient pathway, including the pre-operative phase for surgical cases. Primary outcomes 
of the study will evaluate the increased confidence and satisfaction among MDT members in making complex 
clinical decisions. While this pilot study is not powered to comprehensively evaluate secondary outcomes, future 
study extension will be conducted to systematically assess the software's effectiveness in supporting MDT 
meetings and its impact on both patient outcomes and the experiences of MDT members. 
8.7 
Study Group 
The MDT panel members will be invited by the MDT Panel Chairs (Principal Investigators) and Coordinators to invite 
them to participate in the study.  The panel members will be informed of the purpose of the study and time 
commitment needed to complete the study questionnaires. 
8.8 Inclusion criteria  
MDT meeting panel members, Coordinators and staff submitting MDT referrals will take part.   
8.9 Exclusion criteria  
There are no formal exclusion criteria.  
9. Approaching participants to join the study 
MDT panel members will be invited to participate in the study through their respective Principal Investigators, who 
act as the MDT chairs. A notification will be sent outlining the study's purpose and the One Referral intervention. 
While the effectiveness of this study relies on strong participation across the entire MDT, we acknowledge the 
importance of individual choice and informed consent. Therefore, each MDT member will be asked to provide 
individual informed consent to participate in the study. This approach ensures that ethical standards are maintained 
while also recognizing the collaborative nature of MDT work. 
MDT members will be provided with a Participant Information Sheet detailing the study's objectives, procedures, 
potential risks and benefits, and their rights as research participants. They will also receive a Consent Form to 
document their informed agreement to participate. 
Patient consent for the use of their data in the One Referral system, both for the purpose of the clinical treatment 
and for the research study will not sought.  
Clinical treatment: Personal data processing falls under the common law duty of confidentiality. When patients 
consent to investigation and treatment, this implies consent for care providers to process relevant information to 
facilitate their referral. Research study: No patient identifiable data will be accessed by external researchers. 

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Internal NHS staff will observe MDT meetings to collect data on the MDT review duration, quality and outcomes. 
This data will be pseudonymized by NHS researchers.    
10. 
Study Phases 
The duration of each study phase is designed to align with the frequency of Multi-Disciplinary Team (MDT) 
meetings. This design ensures that an adequate number of MDT meetings are observed in each phase of the 
study. It is important to note that this study duration is indicative and may be subject to adjustment based on 
operational factors. For instance, if an MDT meeting is cancelled or rescheduled, the study period might be 
extended to ensure the target number of MDT meetings is observed in each phase. This flexibility in the study 
design allows for adaptation to the real-world clinical environment while maintaining the integrity of the research 
protocol. 
10.1. 
Pre-intervention phase 
Prospective review of complex cases discussed by the MDT will be completed.  
10.2. 
Onboarding phase 
MDT panel members will be registered on Salutare One Referral via their secure NHS accounts and provided with 
system training. The system training will consist of an instructional video demonstrating how to:  
- 
Set up accounts via NHS account authentication  
- 
Manage notification settings and configure profiles  
- 
Set up a multi-disciplinary team   
- 
Complete a referral form  
- 
Send a referral form  
- 
Report software issues and request assistance  
- 
What to do in the event of system unavailability  
All study participants will be required to complete the onboarding training.  
Additionally, the Salutare support team provides assistance for any difficulties via email and an email chat 
feature. The support team is available during working hours from 8 am to 7 pm, with a response within the same 
working day. If issues cannot be resolved through the video and email support, a call will be scheduled to address 
the problem. The Salutare support team will also update instructional materials based on these interactions. 
10.3. 
Intervention phase 
The study intervention involves NHS staff interacting with the Salutare One Referral software. The interaction with 
the One Referral digital tool is classed as and evaluated as a ‘digital health intervention’. The term, ‘digital health 
intervention’ - first used in the field of digital therapeutics to describe diagnosis, treatment and monitoring of health 
conditions using software and digital applications (FDA, 2022) - has more recently been expanded to cover the use 
of information and communication technology (ICT) in support of health and health-related fields, encompassing 
emerging areas such as the use of advanced computing sciences in big data, genomics, and artificial intelligence 
(WHO, 2019).  

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Clinicians participating in the study will engage with the Salutare One Referral software by initiating patient referrals 
to the MDT through a structured workflow facilitated by the platform. Upon logging into Salutare One Referral 
using their secure NHS accounts, they are guided through the process of creating referrals, leveraging instructional 
videos and software-provided completion instructions. 
The platform automatically populates essential patient data from the NHS Spine, including demographics. Doctors 
supplement this data by inputting specific clinical information pertinent to the referral, such as details about the 
reason for referral, recent test results, and any additional context that could aid in MDT decision-making. 
Once a referral is submitted, MDT panel members utilise the platform to engage in virtual discussions with their 
colleagues as part of pre-MDT preparation. This collaborative environment allows them to share and review 
essential patient information, including medical histories, laboratory results, and radiology examinations, all 
seamlessly integrated into the platform. Salutare One Referral ensures that MDT panel members have 
comprehensive access to the necessary clinical data required for informed decision-making. 
During MDT meetings facilitated by One Referral panel members actively contribute to discussions on patient cases, 
aided by the platform's capabilities to standardise and automate aspects of the referral and review process. As part 
of this process, doctors complete the risk scores of the respective MDTs including, for example, the ASA and SORT 
scores for each patient.  
Following review completion, panel members export the finalised referrals as PDF documents compatible with 
Electronic Patient Record (EPR) systems, ensuring seamless integration of reviewed information back into clinical 
workflows. This integration supports continuity of patient care across healthcare settings and enhances overall 
efficiency in patient management. 
10.4. 
Post intervention phase 
Prospective review of complex cases discussed by the MDT will be completed.  
11. Study Assessments  
11.1 Baseline Assessment  
The Baseline Assessment will be administered to the study participants on the first day of joining the study (Day 0). 
The Baseline Assessment survey will collect the user baseline information, such as their job role and MDT role, 
digital competency level and their views regarding the current safety, efficiency and effectiveness of the MDT.  
11.2 Onboarding Assessment  
The Onboarding Assessment will be administered at the end of the Onboarding Study Phase. This will include the  
System Usability Assessment (SUS) to collect participant feedback following completion of system training.  
11.3 Intervention Assessment  
An intervention assessment will be administered to collect participant views regarding the current safety, efficiency 
and effectiveness of the MDT.  

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11.4 Post-Study Assessment  
Post-study assessment will be administered at the end of the post-study control period. The assessment will 
comprise the assessment of any safety, efficiency and effectiveness gains/losses associated with discontinuing the 
use of the Salutare One Referral Software.  
12. 
Data collection from One Referral 
KPI type  
KPI collected 
Engagement with One Referral 
Number of users set up on One Referral 
Number of comments by users  
Number of referrals processed by MDTs 
This study will employ a mixed reporting strategy to accurately represent different types of data collected 
throughout the study phases: 
Time-Series Reporting: 
Variables that can be meaningfully measured and reported for each MDT instance will be presented as a time 
series. This approach allows for the observation of trends over time and the potential identification of immediate 
and gradual effects of the Salutare One Referral software implementation. Examples include: 
• 
Number of users engaging with the system per MDT 
• 
MDT preparation time 
• 
Duration of MDT per-patient discussion time 
• 
Overall time for MDT meetings 
Aggregate Reporting: 
Some metrics are more appropriately reported as aggregate figures over the entire intervention period or for 
each study phase. Examples include: 
• 
Percentage of cases re-presented to the MDT 
• 
Mean or median time from referral submission to MDT decision implementation 
Where possible and informative, we will provide both time-series and aggregate data. For instance, while the 
percentage of re-presented cases will be reported as an aggregate figure, we may also track the absolute number 
of re-presentations per MDT meeting as a time series to identify any trends. This multi-faceted approach to data 
reporting significantly strengthens the study design and allows for a more comprehensive evaluation of the 
Salutare One Referral software's impact. By incorporating time-series data where applicable, we observe learning 
effects, showing how users' proficiency evolves throughout the intervention period, while also allowing us to 
detect any fatigue effects or declining engagement over time. Regular data collection helps us assess the 
Hawthorne effect, determining whether participants' behaviour changes due to being observed and if this effect 
diminishes. Furthermore, the post-intervention phase data will reveal any carryover effects, indicating whether 
the software's impact persists after its use is discontinued (Friedman, Wyatt & Ash, 2022).  

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13. Schedule of interventions and assessments 
Complex case MDTs (Stanmore Anaesthetics and Royal Free Colorectal Cancer) 
 
Day 0 
Day 1 - 
28  
Day 29 
- 42 
Day 42 
Day 43 
- 98 
Day 98 
Day  99 
- 126 
Day 
126 
Baseline survey 
x 
 
 
 
 
 
 
 
Pre-intervention period  
 
x 
 
 
 
 
 
 
Onboarding period  
 
 
x 
 
 
 
 
 
Onboarding survey  
 
 
 
x 
 
 
 
 
Intervention period  
 
 
 
 
x 
 
 
 
Intervention survey 
 
 
 
 
 
x 
 
 
Post-intervention period  
 
 
 
 
 
 
x 
 
Post-intervention survey 
 
 
 
 
 
 
 
x 
 
High-volume MDTs (Breast Cancer) 
 
Day 0 
Day 1 - 
14 
Day 15 
- 28 
Day 28 
Day 29 
- 56 
Day 56 
Day 57-
70 
Day 70 
Baseline survey 
x 
 
 
 
 
 
 
 
Pre-intervention period  
 
x 
 
 
 
 
 
 
Onboarding period  
 
 
x 
 
 
 
 
 
Onboarding survey  
 
 
 
x 
 
 
 
 
Intervention period  
 
 
 
 
x 
 
 
 
Intervention survey 
 
 
 
 
 
x 
 
 
Post-intervention period  
 
 
 
 
 
 
x 
 
Post-intervention survey 
 
 
 
 
 
 
 
x 
 
High-volume MDTs (Breast Cancer) 
 
Day 0 
Day 1 - 
14 
Day 15 
- 28 
Day 28 
Day 29 
- 56 
Day 56 
Day 57-
70 
Day 70 
Baseline survey 
x 
 
 
 
 
 
 
 

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Pre-intervention period  
 
x 
 
 
 
 
 
 
Onboarding period  
 
 
x 
 
 
 
 
 
Onboarding survey  
 
 
 
x 
 
 
 
 
Intervention period  
 
 
 
 
x 
 
 
 
Intervention survey 
 
 
 
 
 
x 
 
 
Post-intervention period  
 
 
 
 
 
 
x 
 
Post-intervention survey 
 
 
 
 
 
 
 
x 
 
14. 
Study duration 
The total duration of the study will depend on the frequency of MDT meetings and the number of cases 
discussed.  
• 
Stanmore Anaesthetics MDT and Royal Free Colorectal Cancer MDT: The study duration will be 
approximately 18 weeks (4-week pre-intervention period, 2-week onboarding period, 8-week 
intervention period, 4-week post-intervention period)  
• 
Royal Free Breast Cancer MDT: The study duration will be approximately 10 weeks (2-week pre-
intervention period, 2-week onboarding period, 4-week intervention period, and a 2-week post-
intervention period).  
Additionally, 4 weeks are allowed to complete the study data collection.  
15. 
Early Discontinuation/Withdrawal of Participants  
This protocol ensures adherence to ethical considerations while respecting the operational dynamics of the study 
involving multidisciplinary teams, in accordance with UK Health Research Authority guidelines. Given that the 
collective participation of the whole MDT panel is required for the study to proceed, participants cannot withdraw 
individually without providing a reason. Therefore, a collective decision by the MDT is needed to pause or terminate 
the study, ensuring that the integrity and continuity of the research are maintained. 
Study participants will be encouraged to contact the study team with any issues and questions and if they wish to 
opt out. All efforts will be made to resolve any issues. In the unlikely situation that issues cannot be resolved, the 
research team will discuss appropriate measures, such as allowing the panel members to submit referrals using the 
existing process. 
Participants whose employment at the Participating Organisation is terminated during the study will be 
automatically withdrawn effective from their last day of employment, with no further data collected after 
employment ends or after the closure of their email account, whichever occurs first. 

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While every effort has been made to ensure the safety and efficacy of the Salutare One Referral software, it is 
important to outline potential adverse events that might necessitate early termination of the study. The MDT panel, 
in consultation with the study team, may discuss early study termination if any of the following events occur: 
• 
Cybersecurity Incidents: Any breach or attempted breach of the system that compromises or potentially 
compromises patient data or system integrity. 
• 
Severe Usability Problems: Persistent issues that significantly impair the MDT's ability to function 
effectively, such as consistent system crashes during meetings or inability to access critical patient 
information. 
• 
Unexpected Patient Safety Issues or Near Misses: Any incidents or near misses that could potentially harm 
patients due to software malfunction, such as incorrect display of patient data or loss of critical medical 
information. 
• 
Prolonged System Malfunction or Outage: Extended periods of system unavailability that disrupt MDT 
operations and patient care pathways. 
• 
Significant Negative Impact on MDT Efficiency: If the software consistently leads to prolonged MDT sessions 
or increased workload that cannot be attributed to a learning curve. 
• 
Unresolved Critical Bugs: The discovery of critical software bugs that cannot be promptly resolved and pose 
risks to MDT operations or patient safety. 
• 
Ethical Concerns: Any unforeseen ethical issues that arise during the course of the study. 
If any of these events occur, they will be promptly reported to the study's Chief Investigator, Principal Investigator 
and Sponsor. The severity and impact of the event will be assessed, and a decision regarding study continuation 
will be made in consultation with the MDT panel, ethics committee, and other relevant stakeholders. The wellbeing 
of patients and MDT members will always be the paramount consideration in any such decision. 
16 Legal and Regulatory Requirements 
16.1 NICE and DH requirements for Digital Health Technologies  
The One Referral software is classified as a Digital Health Technology (DHT) to be commissioned for use in the 
health and social care system. The design of this study follows standards for evaluating the effectiveness of Digital 
Health Technologies (DHTs) as outlined in the Evidence Standards Framework for Digital Health Technologies (NICE, 
2019) developed in collaboration with NHS England, NHS Digital and other stakeholders. The framework classifies 
DHTs by function and stratifies them into evidence tiers based on the potential risk to users.  
One Referral is functionally classed as a ‘system service’ aimed to improve system efficiency and unlikely to have 
direct and measurable individual patient outcomes. Consequently, it has been classified as Tier A: DHT with 
potential system benefits but no direct user benefits. This pilot has been designed to generate best practice 
evidence standard required by the NICE framework to generate evidence of safety, efficacy, and a value proposition 
to users. As part of this study, we will investigate and evaluate the system’s effectiveness on the duration of the 
patient pathway, from referral to MDT discussion to the decision outcome implementation, e.g. surgery.   
Minimum evidence standard:  
• 
DHT performs its intended function to the scale needed 

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• 
DHT meets Government accessibility requirements  
Best practice evidence standard:  
• 
Published evidence that DHT has a plausible mode of action that is viewed as useful and relevant by 
professional experts or expert groups in the relevant field 
• 
Relevant clinical or social care professionals working in the UK health and social care system have either 
been involved in designing, developing or testing the DHT  
• 
Published evidence to show that representatives from intended user groups were involved in the design, 
development or testing of the DHT and to show that users are satisfied with the DHT 
Salutare Limited abides by the principles of good practice outlined in ‘A guide to good practice for digital and data-
driven health technologies (DH, 2019 as updated).  
16.2 Clinical safety 
Salutare, the manufacturer of One Referral, is committed to meeting the highest standards of patient safety in 
respect of the use of the One Referral software. The Chief Investigator, Prof Kevin Moore, has the lead 
accountability for scientific conduct of the study. Dr Ameet Bakhai acts as the Clinical Safety Officer (CSO) for 
Salutare Limited having completed the required Clinical Risk Management Training (e-learning and CSO course) 
provided by NHS Digital.  Dr Bakhai provides clinical safety expertise and oversight, leads the development of 
Salutare clinical safety processes and documentation, signs off documentation, and oversees compliance with the 
required standards.  
Salutare Limited has developed a ‘Clinical Safety Management System’, defining a systematic process for the 
identification of risk and mitigating actions, in compliance with the requirements set out by the clinical risk 
management standards referred to as DCB0129 and DCB0160. These standards, applicable to Health IT Systems for 
use within the health and care environment, are mandated under section 250 of the Health and Social Care Act 
2012. 
Potential risks have been identified and analysed via a review of potential hazards. A Clinical Hazard Workshop has 
been completed and Clinical Safety Case Report produced. The Clinical Safety Case Report authorises the One 
Referral deployment in this research study.  
16.3 Study risk management  
The following mitigations have been implemented to minimise and manage the risks arising from the deployment 
of the Salutare One Referral software: 
• 
Collaborative Creation and Beta Testing of MDT Referral Form: The MDT referral form will be created in 
collaboration with MDT panel members and comprehensively beta tested prior to live use. This ensures 
that the form meets the specific needs and expectations of the panel, and any issues can be identified 
and resolved early. 
• 
User-Friendly Design: The One Referral software deploys an intuitive, user-friendly design that allows 
users to complete referrals with minimal training. This reduces the likelihood of errors and enhances the 
overall user experience. 

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• 
Instructional Video for Trial Participants: MDT panel members participating in the trial will be required to 
watch an instructional video. This video will explain how to complete and send a referral form, request 
input from others within and outside the MDT, report software issues, and what to do in the event of 
system unavailability. This ensures that all users are well-informed and prepared to use the software 
effectively. 
• 
Back-Up System for Offline Operation: A back-up system will be implemented to create an offline copy of 
a list of patients who need to be discussed at an upcoming MDT. This allows the MDT to proceed even if 
the system is down due to a disruption in network or cloud services, ensuring continuity of operations. 
• 
Comprehensive Application Support: Application support will be provided to address any difficulties via 
email and an email chat feature during working hours from 8 am to 7 pm, with responses within the same 
working day. If issues cannot be resolved through the video and email support, a call will be scheduled to 
address the problem. This ensures that users have access to timely assistance and can quickly resolve any 
issues they encounter. 
• 
Regular Software Updates and Maintenance: Regular software updates and maintenance will be 
scheduled to ensure the system remains secure, up-to-date, and functional. These updates will address 
any identified vulnerabilities, improve performance, and introduce new features or improvements based 
on user feedback. 
16.4 Adverse Event monitoring  
Serious adverse events are any unfavourable and unintended signs, symptoms or a disease associated with 
clinical study intervention. Adverse events in IMP clinical trials are typically categorised as follows:   
• 
Adverse Event: (AE) Any untoward medical occurrence in a patient or clinical trial subject administered a 
medicinal product and which does not necessarily have a causal relationship with this treatment.  
• 
Adverse Reaction (AR) Any untoward and unintended response to an investigational medicinal product 
related to any dose administered.   
• 
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR): Any adverse event or adverse reaction 
that:  1. Results in death 2. Is life –threatening 3. Requires inpatient hospitalisation or prolongation of 
existing hospitalisation 4. Results in persistent or significant disability/incapacity 5. Is a congenital 
anomaly/birth defect. 
• 
Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both unexpected 
(not consistent with the applicable product information) and meets the definition of a Serious Adverse 
Event/Reaction.   
There is limited literature and regulatory consensus on adapting the above adverse event monitoring framework 
for the purpose of digital intervention studies. Bradstreet (2019) reviewed adverse event monitoring in mHealth 
studies for psychosis interventions, concluding that monitoring and reporting of adverse events or effects is largely 
neglected in these studies, with majority of reviewed studies only reporting levels of acceptability, usability and/or 
engagement that are poor surrogates for the direct and contemporaneous assessment of adverse or unwanted 
experiences.  
Bradstreet reports standards and outputs of the adverse event procedure used in the EMPOWER (Early signs 
Monitoring to Prevent relapse in psychosis and promote Wellbeing, Engagement and Recovery, ISRCTN: 99559262) 
feasibility study of the EMPOWER App, an mHealth intervention to enhance detection of Early Warning Signs of 

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psychosis and prevent relapse. He recommends that future mHealth studies adopt a pro-active within-study 
process for the reporting and assessment of adverse events to improve the researcher ability to modify 
interventions as required and to respond adequately to safety issues as and when they arise.  
Unlike the EMPOWER App, One Referral is not classed as MHRA regulated medical device. It is an information 
management and administration system. Nevertheless we have carried out a full risk and hazard assessment that 
is included withing our DCB0129/DPIA which are affixed to this submission and include full details of our risks and 
mitigations.  
Any incidents or events related to the operations of the One Referral software, which result have resulted or could 
have resulted (near miss) in patient care errors, omissions or a delay in patient care provision, will be classed as 
SAEs and Datix reportable incidents.  
In line with the standards proposed by Bradstreet (2019) as implemented in the EMPOWER trial, we will encourage 
participants to report all negative experiences, in particular examples or types of incidents that may occur arising 
or potentially arising from the One Referral software, their seriousness and intensity. All reported adverse events 
will be reviewed by the Chief Investigator, Principal Investigator, Clinical Safety Officer, and other delegated 
research team members for relatedness and severity. Each incident investigation will be accompanied by Corrective 
and Preventive Actions (CAPA). Unresolved critical incidents might lead to early study  discontinuation.  
Detailed Trial Operating Procedures (TOPs) for adverse event reporting will be adopted, detailing the study 
procedures to encourage study participants to report SAEs.  
16.5 Incident reporting  
An incident reporting process has been implemented. All study participants will be asked to report any suspected 
or actual issues to the research team for investigation and resolution. The Salutare research team operates an 
incident reporting system and provides support within working hours, between 9:00 and 17:00 Hrs. An Out-of-
hours IT support is provided by the participating NHS Trust IT service desk, as per standard arrangements.  
16.6 Confidentiality  
All information collected about study participants in relation to this study will be kept strictly confidential. All 
participants will be assigned a non-identifiable study number and the data collected in the study will be linked to 
this number. The study participation itself cannot be kept confidential as the study participants might need to 
engage with the Salutare study research team. Their participation will also be known to other study participants as 
they will interact daily as part of the MDT panels.  
MDT meetings will be observed (either directly or via reviewing MDT meeting transcripts) by NHS researchers to 
collect data on the MDT review duration, quality and outcomes. This data will be pseudonymized by NHS 
researchers.   
The patient information processed by the One Referral system includes information required to complete an MDT 
referral. This includes five key sections for each referral, plus any additional information the referrer wishes to 
provide. It should be noted that images and histology are not accessed through the platform, but the system is a 
means to allow transfer requests.  

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1. Brief medical history  
2. Details of prior MDT discussions, treatments, or relevant history  
3. The question or questions being asked to the MDT 
4. Whether the patient is aware of the referral to the MDT  
5. An assessment of frailty or fitness of the patient 
This data will be processed for the purpose of direct care provision.  
16.7 Cybersecurity 
The One Referral software is fully compliant with the Data Security and Protection Toolkit (DSPT) standards. We 
prioritise the security and privacy of our users by implementing robust cybersecurity measures, including: 
• 
Data Encryption: All data in transit and at rest is encrypted using industry-standard protocols to ensure 
confidentiality. 
• 
Access Controls: Strict access controls are in place, ensuring that only authorised personnel can access 
sensitive information. 
• 
Regular Audits: We conduct regular security audits and vulnerability assessments to identify and address 
potential threats. 
• 
Incident Response: A comprehensive incident response plan is established to promptly address and 
mitigate any security incidents. 
• 
Compliance: Our platform adheres to all relevant regulatory requirements and best practices to ensure 
the highest level of data protection. 
By maintaining these stringent security measures, we ensure the safety and integrity of our users' data. 
16.8 Medical Device Regulations 
The existing One Referral software does not fall under the definition of software that is considered to be a medical 
device, as defined by the Medicines and Healthcare Products Regulatory Agency (MHRA). As such, it is excluded 
from medical device regulations. Therefore, this research study is not considered a clinical investigation aimed to 
access patient data for the generation of clinical evidence for CE marking and is not required to be registered with 
the MHRA. Ethics approval is sought through the Health Research Authority (HRA). 
16.9 Ethical compliance  
The study will only commence once evidence of d Health Research Authority (HRA) approval is in place.  This study 
will adhere to the principles outlined in the NHS Research Governance Framework for Health and Social Care and 
the principles of good clinical practice.  It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  In conducting the study, the sponsor shall comply with all 
laws and statutes as amended from time to time, applicable to the performance of the study.  

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17. 
Quality Assurance Procedures 
The Sponsor Quality Assurance Manager will provide the study monitoring plan. Access will also be granted to the 
authorised representatives of the inspecting regulatory bodies, the Sponsor organisations, and the funding body, 
to ensure the study maintains protocol and regulatory compliance and adherence to Standard operational 
procedures and local policies.   
17.1 Study Monitoring  
The study may be monitored or audited in accordance with the current approved protocol, Good Clinical Practice 
(GCP), relevant regulations and standard operating procedures. Lead researchers involved in the study will have up 
to date GCP training. 
17.2 Protocol Deviations  
A study-related deviation is a departure from the ethically approved study protocol or other study document or 
process (e.g. consent process or administration of study intervention) or from Good Clinical Practice (GCP) or any 
applicable regulatory requirements. Any deviations from the protocol will be documented in a protocol deviation 
form and filed in the study master file. 
The reporting procedure for any potential protocol breaches will be for the study team to report to Prof Kevin 
Moore, Chief Investigator. Any potential breach will be assessed by Prof Moore and Dr Bakhai (CSO) to establish 
whether a non-compliance/deviation may be a potential serious breach.  
18. Payments and incentives 
Study participants will receive Amazon Vouchers valued at up to £20 as a token of appreciation for their time.  
19.  Funding  
Salutare Limited and the North Central London Cancer Alliance are providing funding to undertake this study.  
20. Indemnity  
Salutare Limited, the study sponsor, is providing indemnity to meet the potential legal liability for harm to 
participants arising from the design and management of the research, arising from the Sponsor’s negligent 
performance. The participating NHS organisation (host institution) is providing indemnity to meet the potential 
legal liability for harm to participants arising from negligent study conduct.  
21. Intellectual Property 
All Intellectual Property Rights and Know-How arising from this study, Salutare One Referral (including but not 
limited to its design and use alone or in combination with other tools, devices, technology products or interventions, 

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and/or the study protocol and associated documentation, but excluding any clinical procedure and improvements 
thereto that are clinical procedures of the Study Site), shall vest in the Sponsor of the study, Salutare Limited.  
22. Presentation and publication plans 
Research outputs and outcomes will be submitted for publication in healthcare journals and may be presented at 
relevant conferences or used for any subsequent guidance discussions with NHS executive bodies. Participants will 
not be identifiable from any summary of findings or papers written for publication. A Steering Committee chaired 
by the Chief Investigator, formed to supervise the conduct of this research study, will authorize publications and 
presentations relating to the study. Named authors on the main study publication will include the Chief Investigator, 
the Principal Investigator and other investigators who have contributed to the design, delivery, and analysis of the 
study.    
23. 
End of Study  
The study end date is deemed to be the date of the last data capture. It is expected to be 10 weeks after the last 
participants joins the study, allowing for additional 2 weeks of assessment data collection.  At the end of study, the 
Sponsor will archive securely all centrally held study related documentation for a minimum of 5 years.  
 
 
 
 

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