Clinical staff members play a pivotal role in the delivery of the ongoing Clinical Observational Study. Their expertise and dedication are essential for the successful execution of the study. To better understand what their roles and responsibilities are, we have engaged in a conversation with Ms. Lauren John, a research practitioner affiliated with the Royal Devon and Exeter Hospital.
Lauren John is a research practitioner at the Royal Devon and Exeter Hospital working within the gastroenterology department. She has studied a variety of different areas with a focus on psychology and performance. Over the last ten years she completed a BSc (Hons) in Sport and Exercise Science at Cardiff Metropolitan University, FdSc Addiction Counselling at the University of Bath, MSc Sport Psychology at Cardiff Metropolitan University, and MSc Psychology at Manchester Metropolitan University. This series of academic qualifications has allowed her to thrive in a research job working within a small team.
Lauren’s aspirations are to do a Doctorate degree in the near future focusing on psychology. She enjoys building a rapport with the patients on all the studies and being able to provide them with support on the research journey. Currently, she’s dedicating her efforts to our on-going COS: here is how the study looks through her eyes.
- What is your specific role within IDEA-FAST and the clinical observational studies? What are your main responsibilities?
I am a research practitioner. I approach, screen, consent, and deliver the study. I do all of the data downloading, along with all of the visits.
- What does your day-to-day job include? What kind of training and support have you received to carry out your role in this study?
Depending on the day, I will do a visit, download data, upload data to the University of Cambridge. I will screen clinics most days to find potential participants. Additionally, I work on multiple other studies throughout the week, so I do visits, and screen for those also.
- How do you ensure that the study is conducted in accordance with ethical and regulatory requirements, as well as the protocol?
Good clinical practice is a fundamental part of the study. There have been challenges in the study due to the different ethical requirements within the National Health Service in comparison to other places who are doing this study. This has been challenging due to us having to wait for amendments before using some of the provided paperwork unlike other sites.
- Can you describe the process of patient recruitment and selection for this study?
Majority of our patients have participated in research previously and have said they are happy to be contacted for future research. I contact these participants and screen them over the phone before bringing them into clinic for the consent visit. The Irritable Bowel Disease nurses and consultants provide us with details of patients they are happy for us to contact for the study and are very helpful in the recruitment process.
- How do you ensure that patients receive the appropriate information about the study, give informed consent to participate, while also maintaining their privacy?
The patients receive the information sheet and have time to read and ask questions prior to informed consent. During the consent visit I spend time speaking to the patient to ensure that they understand how the study will work. Furthermore, I specifically speak to the patient about their data, confidentiality, and that they can withdraw at any point. Emphasising that research is optional.
- How do you work with other members of the study team, such as investigators and data managers, to ensure the smooth running of the study?
I work closely with the consultants within the department which helps provide me with information for potential participants. During our weekly MDT I will highlight the study to the consultants and nurses, which allows them to send through the information of any potential patients. The IBD nurses provide us with the majority of our participants through their clinics and the gastro day unit which is extremely helpful.
- What do you think are some of the potential benefits of this clinical observational study for patients and the wider healthcare community, and how do you hope it will contribute to improving patient care and outcomes?
The patients always express that this study is beneficial as fatigue is a symptom the majority of the patients and people they speak to suffer with. I hope we are able to use these devices in future in order.
- What challenges have you encountered so far in delivering the study? How have you overcome these impediments?
Challenges have been organising visits and maintaining a steady flow of the study. Furthermore, there have been some challenges as the study has been set up and using the different databases. Additionally, from the beginning I have been educating myself on a new area that I have not worked in before and learning about IBD has been a challenge however I have received support from my colleagues and have been able to grow my understanding.
- What is the aspect you enjoy most about being involved in the IDEA-FAST COS?
I enjoy building a rapport with the patients over the six months that they are part of the study. I feel as though I am a small part of a big project aiming to help individuals understand fatigue which allows the job to be rewarding.