RESEARCH PROTOCOL

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RESEARCH PROTOCOL – BREAST CANCER DECISION SUPPORT SYSTEM MULTICENTRIC PROJECT IN DEVELOPED AND EMERGING ECONOMIES

 

I. BACKGROUND AND SIGNIFICANCE

               There is a global disparity in cancer care arising out of patients’ differential access to healthcare, socioeconomic status and geographic location, which is leading to delayed diagnosis of cancer and poor survival. There are various factors which contribute to this disparity, e.g. chronic shortage of trained healthcare professionals, medical malpractice, medical errors, poor patient compliance, lack of evidence-based practice, medical over-investigation and overtreatment.

II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES

-       Broad Objective - Develop computational approaches that can reduce cost and improve cancer care survival. This can be achieved by the use of data science and cutting-edge modern technologies. Thus, the disparity in cancer care due to geographic location, access to healthcare, socioeconomic status and genetic/biological factors can be reduced.

-       Specific Objective – To test and assess the clinical effectiveness of a data-driven, evidence-based, up to date, cancer-specific artificial intelligence matrix which will be delivered to the end-users, i.e. physicians and patients through a user-friendly mobile & web interface which will act as a real-time, dynamic, multidisciplinary decision- making tool. The effectiveness will be assessed by a global multi-centric research project, which will involve research partners from universities/teaching hospitals/and institutes meeting the eligibility criteria. Please refer to the website to understand the details for the partner’s eligibility criteria.

III. METHODS

A.    Study Design

  • This study has both prospective and retrospective component involving breast cancer patients, subject to system readiness and availability of resources.

  • The aim of the project is to try and develop a randomised control trial if logistically possible.

  • This project will be tested in one of the National Health Service’s breast cancer centres in the UK and also in a partner hospital in India.

  • Blinding of the trial is not a mandatory element of this trial. Enrolment of a patient into this trial will involve informed consent and information about data privacy and security.

  • The period of this study will vary between one month to 6 months depending on the outcome of the pilot, case volume and logistic ease in carrying out the trial.

  • The primary endpoint of this trial is to calculate the amount of  a. Time saved by the deployment of the clinical decision support system (only applicable to prospective component) b. The multidisciplinary tumour board outcomes where the human decision will be compared with the decision of the cancer specific algorithm.  

  • The secondary endpoints of this trial include system performance, physician satisfaction and patient satisfaction with use of the system, if applicable.

B. Study Population

Patients with suspected or proven Breast cancer or proven can be enrolled into the project. There are no exclusion criteria for now; however, the final call for exclusion criteria will be made after the piloting of the project is complete. The exclusion criteria will be finalised in consultation with the research team working at the local research partner’s facility.

C. Assessment of Resources

The Institute or research centres should have the following facilities in order to qualify as a research partner.

  • The organisation should have a demonstrated, strong research interest in terms of conducting research projects, contributing to scientific publications and having the resources necessary to carry out projects.

  • The organisation should have a dedicated IT department to deal with information governance and technologies

  • The organizations should have the manpower in place on a part-time or full-time basis to carry out the research

  • The organisation should have a dedicated place for research activities.

  • The organisation should have computers or laptops installed to facilitate digital research projects. 

The study will involve placement of a patient liaison manager, field research officer and field research supervisor. These 3 people will be provided by the UK team and they would

1.     Have sufficient access to the study population

2.     Have adequate place to conduct the study

The research partner should provide a research fellow or research trainee. The research fellow or the research trainee should have

1.     Sufficient time to conduct and complete the study

2.     The qualification to conduct the study

3.     Been adequately trained on the protocol and the specific research-related duties.

D. Study Procedures

  •       Any patient who has got suspected or confirmed breast cancer is an eligible candidate for the trial.

  •       The exclusion criteria are to be set up by the local team in consultation with the UK team at the partner research facility.

  •       Following the recruitment, the patients will be registered in the research database and will be allocated a research identification number and a QR code.

  •       The patient will be explained about the project and will be given a clear option to accept or reject

  •       The finalization of the recruitment policy is to be made in consultation with the local partner

E. Case Journey

  • The patient will be taken to an interviewing area where the patient liaison manager will help the patient to fill the history taking form on a web or mobile interface.

  • Following this, the patient will proceed for a consultation with the doctor. The doctor will have the opportunity to view the information provided by the patient.

  • Subsequently, the results of the diagnostic work up e.g. ultrasound, mammogram, biopsy, pathology, histopathology, hormonal study and genetic study will be entered into the system by the research lead from the partner institute or by the field research officer.

  • The delegation of this part of the project is to be clearly agreed upon

  • The primary end point of the study will be a. Time saved by the deployment of the clinical decision support system((only applicable to prospective component) b. The multidisciplinary tumour board outcomes where the human decision will be compared with the decision of the cancer specific algorithm. Also, the human decision vs the machine decision and the human error vs the machine error will be studied.

  • Field troubleshooting - During the conduct of the trial, any technical issue regarding functioning or usability of the software will be dealt through a clear-cut mechanism, which will involve the IT team to troubleshoot at the earliest. This includes bug fixing, enhancement and local customization.

  • The assessment and performance of the project will be reviewed every week and month by the research supervisor and team leader of the local research partner.

F. Data collection

The data collection will include their demographic details, clinical details, physical examination details, pathology results, psychology results, cytology results, histopathology results, radiology investigation results and the consultation details of other allied specialties.

The target sample size is 5000 patients depending on the patient turnover at the research partners facility. If the caseload is inadequate, consideration will be given to retrospective study of known breast cancer cases. The details of the cases will be entered into the application and the results of the decision support system will be compared against the multidisciplinary tumour board outcome.

IV. DATA COLLECTION

We will be collecting the patient's name, date of birth, patient’s identification number with the hospital, research identification number, demographic details, clinical details e.g. nature of the disease, symptoms, duration, treatment taken, investigation results etc.

Mentioned in detail in ethical consideration

V. DATA ANALYSIS

 A. Sample Size Consideration - 5,000 - 10,000 patients, depending on the response we get in our pilot study.

B. Statistical Methodology - Comparisons to be made and statistical tests, depending on the type of study conducted, to be used for the comparisons.

VI. DATA AND SAFETY MONITORING PLAN (if applicable)

A. The provisions for monitoring the data for safety is mentioned in detail in the Ethical Consideration.

VII. STUDY LIMITATIONS

 A. Potential Limitations include, but are not limited to, logistical issues and collaboration necessary to carry out the project at the research partner facility. These may potentially force the project towards a retrospective analysis of the cases, which will not provide the benefits attributed to a prospective case study.

VIII. ETHICAL CONSIDERATIONS

Who Are We?

We are Team YouDiagnose, and the details of the team structure are mentioned on the website, www.youdiagnose.online

What is this project about?

This is a research project which will involve patient data. The project is meant to give us profound insight into how we can make the clinical workflow efficient and cancer-care better. This research, when expanded, will help mitigate the global disparity in cancer care.

What is your stand on patient data safety?

YouDiagnose is committed to patient data safety. A dedicated server will solely be used for this project. Progress will be made after a data protection/privacy impact assessment.

How will the data be collected?

The data will be collected from the patient after a valid informed GDPR(General Data Protection Regulation) consent. The patient will be given a choice to accept or reject. After valid consent, the patient will then interact with the software on a tablet or mobile device and enter the clinical information. Once the patient submits the form, the data will go to the server.

How will the information be stored?

Information will be stored in the military-grade servers located in the United Kingdom.

How long will the data be stored?

The data will be stored until the project is over or for 3 months, whichever is later.

Will that data be erased?

The data will be erased entirely without any option for recovery.

How much data will be collected?

We will be collecting the patient's name, date of birth, patient’s identification number with the hospital, research identification number, demographic details, clinical details e.g. nature of the disease, symptoms, duration, treatment taken, investigation results etc.

Whose data will we collect?

Suspected and proven cancer patients.

What is the nature of the relationship between the researcher and enrolled patients?

We will be researchers and will have no direct relationship with the patient as a doctor.

How much control will the patient have?

The patient will have full control over the data and can edit it till it is submitted. Once it is submitted, the patient can still request a change in the data. Afterwards, the information will be reviewed with the clinician at the time of consultation and later this will be provided to the patient through a clinic consultation letter, if applicable in a geographic location.

What ways should the patients expect the researcher to use their data?

The patient can expect the data to be used for research for the purpose of improving the healthcare system from its current state.

Will children or other vulnerable groups be included?

No, children or any vulnerable groups, e.g. learning disabilities, will not be included.

Are there prior concerns over this type of processing or security flaws?

None at all

What technology will be used?

We will be using state-of-the-art industry-leading technology for data privacy and confidentiality.

Are there any current issues of public concern that should be factored in?

The patient will know all aspects of the trial at the time of enrolment, and therefore, no concerns will be left unaddressed.

Are you signed up to any approved code of conduct or certification scheme (once any have been approved)?

We will be guided by Caldicott's guidelines. https://www.igt.hscic.gov.uk/Caldicott2Principles.aspx

What are your specified plans for data protection?

Amazon AWS Server, London.

Cloud-based or web-based.

Industry-leading standards of security

End-to-end encryption

Advanced features with regular penetration testing.

Details - https://aws.amazon.com/security/  

Only people who are employed in the organisation will have access to the data. No external person will have data access.

How will you ensure the security of the data?

The data will be handled by authorised people from YouDiagnose, viz. the clinical staff and healthcare professionals.

The data will be protected by the following features:

auto-logout, end-to-end data encryption, secure password policy and use of two-factor authentication for every registered user.

Furthermore, the user interface on the website will be compliant with GDPR policies.

How many people will have access to this data?

We aim to keep the number of accesses to a maximum of 25 people. From YouDiagnose, around 10-15 people might have access to the data. However, the number of people who need to have access from the partner side will be determined in consultation with the partner. The effort will be to ensure that minimum people have access to the data and that too on a need to know basis only. 

How long will this project last?

The project is expected to be completed within 3-6 months.

What will be our approach towards patient consent?

At the beginning of enrolment, we will take the patients through a consent process providing them with the details of the process along with privacy policy, cookie policy and terms and conditions with an option for the patient to choose or reject. We will have a leading industry standard of practice with regards to the privacy policy, cookie policy and terms and conditions developed in consultation with a legal consultant.

How will you keep your record of consent?

We store two copies of the consent form in the server.

Will any personal data be anonymised as part of the research?

Yes, following the data collection and review, all the data will be anonymised. Personal data use will be kept to a minimum in keeping with the Caldicott’s principle.

What type of training will the staff have to access the data?

We will ensure that everyone who is using the data has undergone training in project induction protocol or else it will be mandatory for them to do a tutorial on GDPR compliance and Caldicott principles.

What mandatory Information Governance do the researchers have to complete? 

Researchers have to complete mandatory training in IT before anyone can have access to the server data

Does it cover confidentiality?

Yes, it does

If external to the Trust/Hospital/University/Institute, how will you arrange appropriate Information Governance/ confidentiality training? Who will provide this?

This is provided by the Trust/Hospital/University/Institute as a part of induction. If someone hasn’t done this, we will get this done externally.

https://www.virtual-college.co.uk/courses/healthcare-courses/confidentiality

https://www.virtual-college.co.uk/courses/healthcare-courses/statutory-and-mandatory-clinical-bundle

IX - Risks and Side Effects (Applies to studies using human subjects)

1. Potential Risks (includes medical, psychological, legal, financial, social) - The potential risks involved in this project is wrong decision-making by the decision support system. However, such a risk is mitigated or eliminated by the very fact that the decision support system is only to be used for research purpose on an experimental basis without using the decision for patient care. In other words, this project is only for research purpose and is not an integral part of patient care or for patient decision-making process. The outcome of this decision is to be validated by a clinician who will bear the responsibility of implementing such a decision and the research team will not be responsible or answerable for any consequences arising out of wrong decision-making by the clinical decision support system during the research process.

Any adverse effect arising during the research can be emailed to grievances@youdiagnose.online