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The Rory Morrison Registry Project

The Rory Morrison Clinical Registry (RMR) Project

Introduction
The Rory Morrison WMUK Registry (RMR) Project focuses on patients who have Waldenström’s macroglobulinaemia (WM) and related conditions including but not restricted to cold agglutinin disease (CAD), amyloidosis, anti-MAG neuropathy and Bing-Neel syndrome. There are about 350 new cases per year of WM diagnosed each year in the UK. Being a rare disease, clinical trials in this field are limited. However, in the light of recent scientific developments, treatment options are on the rise, so it is important to capitalise on this tide of progress and become part of the story, rather than just onlookers.
In order to understand the UK perspective on WM, to contribute to the global effort to improve clinical outcomes, and to work with funding authorities and the Pharmaceutical industry towards more equitable access to novel therapies, there is an urgent need to collect real world data on UK patients affected by WM and related conditions. Accurate demographic and clinical data, robust information around biomarkers, treatment options and patient-related outcomes (PROs) will facilitate the design and entry of UK patients into clinical trials and demonstrate the clinical value of drugs considered for adoption by the Cancer Drugs Fund (CDF) and National Institute for Health and Care Excellence (NICE) within the NHS.
After more than 3 years since the conception of the project, including fundraising by patients and the families as well as financial support from commercial partners, the RMR Project is now being launched using database software provided by Dendrite Clinical Systems.
One of the key roles of the RMR project is to assess the whole process of care for patients diagnosed WM and related conditions in England and Wales, and thereby help improve the quality of clinical services and outcomes for patients. The RMR Project is a collaborative project between patients, who have provided their full support and the WMUK Doctors’ Forum, working closely with organisations such as the Lymphoma Association and the International Waldenström’s macroglobulinaemia Foundation (IWMF) to ensure that the Registry focuses on information that is really relevant to real-world patient outcomes.
 
Registry Front End

Frequently Asked Questions

Who is running the RMR project?
A consortium of WMUK and Dendrite Clinical Systems is running the RMR Project. WMUK is a Registered Charity dedicated to improving outcomes for patients with WM and related conditions by bringing WM patients and medical professionals closer together. Dendrite is a British company specialising in disease registry database systems. The Project’s Lead is Dr Shirley D’Sa, Consultant Haematologist and Lead of the WM Service at University College London Hospitals NHS Foundation Trust, London. Dr Joshua Bomsztyk (pictured) is in post at UCLH to manage data collection and drive the project forward.

Who should contribute data to new RMR Project?
At the time of launch, 10 hospitals in England and 1 in Wales that provides specialist care for patients with WM and related conditions are signed up to submit their data to the national registry on a regular basis.

What data items are collected?
The RMR is designed to collect data on patient demographics, disease profile, treatments and outcomes. The addition of direct entry of patient-related outcome measures (PROMs) will be launched within a few months, via web-based and mobile platforms.
 
Does the RMR hold any sensitive data?
Yes – the registry holds detailed clinical records on patients but the whole system resides on a secure server within the dedicated NHS computer network.

What Information will the RMR Project produce?
The new RMR project aims to achieve several key objectives, including, up-to-date information on best practice in this clinical area, an invaluable research tool for clinicians and improved outcome information for patients and their families.

Is it possible to make a request for secondary use of data?
The RMR team is committed to sharing data and ensuring the greatest possible use comes from the hard work of collection. There will be a Committee that will review all requests on a case-by-case basis to decide which ones will be approved.

 

RMR Information for Patients

We need help from patients and members of the public to ensure that we are moving in the right direction.
Patient outcome data is collected by various bodies and organisations, including the NHS. However, such data is collected for objectives that vary from ours, such providing and commissioning chemotherapy. The RMR is different from national data collection initiatives, because it aims to monitor the whole patient pathway including complications and outcomes, in a way that is specific to WM and related conditions. It is this that will make it even more valuable in terms of identifying and promoting best practice and improving patient care in the future.

We are very keen to continue to involve patients in the development and implementation of the RMR. This should ensure that the Registry is asking questions that are relevant to the people who are particularly affected by the condition. To this end, we have formed a Registry Advisory Committee (RAC), which will be invited to contribute throughout the project. This currently comprises patient and professional Trustees of WMUK, but going forwards, ongoing patient involvement will be sought, so please watch this space!
We anticipate that there will be many ways in which patients and members of the public will be able to contribute to the RMR providing a different perspective, in terms of experience, interests, knowledge and expertise to that of the clinicians and Registry committee.
If you would like to join this group, please email info@wmuk.org.uk for further information.
Thank you for taking the time to read the information for patients below. Please give your feedback using email to info@wmuk.org.uk

FAQ - Information for Patients
Background
Accurate clinical information about patient care can provide an excellent way of improving outcomes, by monitoring the standard of care received and record information on treatment. Such information also provides a context for variations in clinical practice in different parts of the country and the development of clinical trials. Such data also promotes the conduct of clinical audit, which is a continuous process of looking at the care provided and asks:
What should we be doing?
• Are we doing it?
• How can we improve?

Audits
can be used to assess various aspects of patient care including:
• Structure – such as the availability of specialists for this condition in England and Wales
• Process – such as whether clinical guidelines for the treatment of WM and related conditions are being followed
• Outcome – such as quality of life and survival of patients with WM
If the right questions are asked, the data collected can also be used as a research database providing a valuable resource for researchers that will inform best practice in the future. It can answer important questions such as:
• What treatment works best?
• How can we improve a patient’s quality of life?
• Can we assess the risks of a particular treatment more accurately?
All data collected is subject to strict rules of confidentiality so patients do not need to worry about it getting into the wrong hands.
What is the RMR?
The RMR is the new national clinical registry for WM and related conditions in England and Wales. It aims to improve the quality of services and the outcomes achieved for all patients affected by these conditions. A team of specialist clinicians and expert patients will work with statisticians and cancer audit experts to manage the RMR. RMR will collect information about the diagnosis, management and treatment of previously and newly diagnosed patients, and their outcomes at participating centres. At present there are 10 centres in England and one in Wales, but going forwards, we plan to recruit more centres, so as to improve the coverage of the country. The findings from the RMR will contribute to changes in clinical practice ensuring that patients receive the best care possible and experience an improved quality of life.

Who manages RMR?
The RMR has been developed in partnership with WMUK, a team of specialist clinicians and Dendrite Clinical Systems.

What information does RMR collect?
The RMR will collect information relating to:
● Characteristics of newly-diagnosed WM
● Diagnosis, staging and planning of initial treatment
● Treatments received
● Complications of treatment
● Overall and disease-free survival

How is RMR data processed?
The hospital trust providing your care will send your information to Dendrite Clinical Systems Ltd electronically using secure data transfer methods.
Dendrite will act as guardians for your data and will store it securely. They may link RMR data to other NHS databases held by NHS Digital and Public Health England. These databases hold patient information relating to hospital stays, chemotherapy given and survival. Your name, date of birth and NHS number will be used to link RMR to the NHS databases. The linked information will help us to check whether RMR data is accurate. Data linkage will also provide information that will help us to improve our understanding about treatment choices and how best they can be combined to benefit patient care and survival.
When personal identifiers are no longer needed for patient tracking they will be permanently removed from a record.

Reporting RMR data
No personal identifiers will be used in RMR reports. Once a year Dendrite will combine the information from individual hospitals with data from other parts of England and Wales. They will process the data and organise it by region, hospital trust and consultant. They will then remove your name, date of birth, NHS number and any other information that could be used to identify you. Dendrite will work with WMUK to produce annual RMR reports and local action plans.

Who will benefit from RMR data?
RMR will publish reports annually. This will enable stakeholders to check progress and assess what outcomes have flowed from the data collection, such as submissions to congresses, the opening of clinical trials, numbers of patients recruited, publishing papers in medical journals to provide information about the best standards of care, providing information for public health.

How reliable is the RMR data?
As RMR is a national registry some items are bound to be inaccurate or missing. Linking your data with information in other NHS databases will help us to check whether the data provided by each hospital is complete and accurate. There will be a dedicated clinician responsible for overseeing the accuracy of data upload via the web-based platform and via face-to-face contact with data uploaders at participating sites.
Once your information has been added to RMR only your clinicians will be able to access, check and change it. Dendrite will keep a record of all changes that are made.

How we keep your information safe?
Data protection and privacy is an important part of RMR so no individual patient names can be identified in the results. The data controller (Dr Shirley D’Sa, UCLH) and Dendrite will make sure the data collected is subject to strict rules of confidentiality as laid down by Acts of Parliament, including the Data Protection Act 1998 and the Health and Social Care Act 2001. Page 5 Last updated: 27th April 2017

How long will we keep your information?
By collecting a large amount of information, it is easier to identify the most effective treatments, which can benefit patients. This can change cancer care so that in future patients will survive longer and have a better quality of life after treatment.
We will retain the RMR data for a period of up to 15 years to enable us to collect, assess and report on the complications and outcomes of treatments.

Can I opt out of RMR?
National registry data is an effective when it contains information from as many patients as possible. If you do not want your information to be collected for the RMR audit, please tell the people who are treating you. It is possible that some RMR information may already have been transferred to Dendrite. When the people who are treating you inform Dendrite about your decision, Dendrite will make sure that any RMR information that can be removed from the registry is destroyed. This will not affect your treatment in any way.

Contact details
If you have any general questions about this audit please contact info@wmuk.org.uk