The increasing availability of routine data combined with the difficulty and expense of conducting randomised controlled trials (RCTs) motivates the investigation of more efficient study designs, and the increased use of observational data to provide a stronger evidence base for some interventions. While continued efforts should be a made to deliver high-quality RCTs there is also merit in trying to improve the rigour of non-randomised research designs. One such method is an interrupted time series (ITS), the importance of which is recognised by the Cochrane Collaboration’s Effective Practice and Organisation of Care Group (EPOC) and the IDEAL framework for surgical innovation

Our project will deliver proof of concept for a scalable framework for the collection and analysis of patient-reported outcomes (PROMS) as time series, using electronic data capture and incorporating a robust and compliant electronic informed consent form (e-ICF) mechanism. PROMS data will be sent to the Clinical Trials Unit (CTU) data hub, and individual study team members will remain be blinded. This will provide a foundation for piloting and conducting large-scale, non-randomised healthcare evaluations with greatly improved rigour and efficiency. This methodology could significantly reduce NHS and other study support costs through its use of electronic data capture and exploitation of NHS digital routine data.

 Specifically, we aim to:

1. Develop and pilot a robust, compliant patient electronic informed consent form (e-ICF) and patient reported outcome measures (PROMS) platform (“the PROMiSe platform”);

2. Assess user acceptability of the PROMiSe platform in diverse user-groups (Asthma UK patient and public involvement (PPI) group, Bowel and Cancer Research charity PPI group, Birmingham Elders PPI group & a selection of clinical trial researchers);

3. Investigate and review the challenges of linking PROMiSe data to clinical data from a variety of sources, and demonstrate proof of concept for the EMIS Web general practice database;

4. Review and (if necessary) develop statistical methods for the analysis of interrupted time series (ITS) data;

5. Hold a workshop for representatives of UKCRC-registered Clinical Trials Units and other stakeholders to disseminate the proposed framework and methods.

While our work will establish proof-of-concept using surgery and primary care as exemplars, we want to develop and report a framework that has wide generalisability. We therefore propose inviting a representative from each UK clinical trials unit, industry clinical IT representatives, sponsors, R&D/CRN delivery managers and representatives from patient groups to a workshop at which we will present the pilot study data and discuss the usefulness of the method for different clinical conditions/interventions, the feasibility of e-ICF and PROM data collection for conditions/interventions where the method would be considered useful, issues surrounding data linkage, implementation strategies around recruitment in primary and secondary care settings (including NHS support costs identified), and methods of analysis. We will also discuss with clinical IT providers the possibility of developing a commercially viable, integrated digital healthcare application.

This project is funded by the NIHR and has received ethical approval from Queen Mary University of London. Collaborators include Imperial CTU, Birmingham CTU and Birmingham Elders PPI, Edinburgh CTU and Asthma UK PPI group, National Bowel Research Centre and Bowel and Cancer Research charity.

For more information about this project please contact:

• Shiva Taheri                                                                                            

Clinical Research Coordinator              

National Bowel Research Centre   

Queen Mary University

•  Dr Richard Hooper       

Reader in Medical Statistics                

Pragmatic Clinical Trials Unit

Queen Mary University

Queen Mary University of London is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Queen Mary University of London will keep identifiable information about you for 20 years after the study has finished until 2038.

Your rights to access change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information at http://www.jrmo.org.uk/

Pragmatic Clinical Trials Unit (PCTU) at Queen Mary University will collect information from you for this research study in accordance with our instructions.

NHS/other site will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Queen Mary and regulatory organisations may look at your medical and research records to check the accuracy of the research study. [NHS site] will pass these details to Queen Mary along with the information collected from you. The only people in Queen Mary who will have access to information that identifies you will be people who need to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.

Pragmatic Clinical Trials Unit (PCTU) at Queen Mary University will keep identifiable information about you from this study for 20 years after the study has finished until 2038.

As a University we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).***

Please find the slides from the workshop held on 4th July below:

PROMiSe Study Workshop: Overview [PDF 1,001KB]

PROMiSe Study Workshop: User Acceptability [PDF 327KB]

PROMiSe Study Workshop: Statistical Challenges [PDF 986KB]

PROMiSe Study Workshop: Data Linkage - proof of concept [PDF 566KB]

PROMiSe Study Workshop: Linkage with clinical data [PDF 3,002KB]