York Teaching Hospital move from paper CRFs to electronic data capture for the FIT (Faecal Immunochemical Test) study.
York Teaching Hospital NHS Foundation Trust provide a comprehensive range of acute hospital and specialist healthcare services for approximately 800,000 people living in and around York, North Yorkshire, North East Yorkshire and Ryedale.
As a teaching hospital, York has a strong track record of clinical and research excellence with over 100 trials in their portfolio. The trust conducts hosted research and sponsored studies across ICU, cardiology, oncology, gastroenterology, ophthalmology and anaesthetics.
One of their current trials is the FIT study. Funded by Humber Coast and Vale Cancer Alliance, FIT Phase III is an investigation into whether a stool test can be used to decide if patients need to be referred urgently to hospital by their GP, under the 2-week wait referral pathway or whether they can be seen routinely or treated by their GP.
Patients referred under the 2-week wait referral pathway will often undergo invasive investigations such as a colonoscopy however, as few as 3% of patients referred are found to have bowel cancer. FIT could be a useful tool in ensuring that resources are used more effectively.
All participants recruited into the study at one of 13 hospital Trusts across Yorkshire and Humber will be provided with a kit and leaflet which explains how to do the test at home, before having the colonoscopy.
The FIT is posted to the laboratory at York Hospital which analyses the samples. The sites can then complete a case report form (CRF) for each patient. Once completed, the results are sent to the central team at York for analysis.
In earlier phases, trial data from the large patient base was captured with pen-and-paper and manually transcribed into a database. This process was no longer adequate as it was time consuming, error-prone and labour-intensive for the research team.
One of the main challenges with paper was the time it took the sites to post the forms back to York. The sites would mail forms in batches, resulting in a lengthy wait time for the central team and slower data analysis. Moreover, forms lost in transit needed to be resubmitted adding further cost and delay.
As soon as the forms arrived, the central team would need to decipher handwritten notes, correct typographical errors and query missing/incorrect data with the hospitals, extending the process further.
Once the form had been verified, the central team would begin the laborious process of manually transcribing form data into Excel or SPSS. Prolonged data entry is a tedious task meaning there was a high risk of transcription errors when keying the handwritten forms of over 5,000 study participants.
York had an urgent requirement to replace its paper-based system for Phase III of the FIT study. The clinical trials team decided to move to an online solution to allow hospital sites to capture study data electronically. The replacement system needed to improve data accuracy, reduce administrative burden and speed up data capture.
Although my colleagues were looking at lots of different solutions for general use, this was the first one we looked at for the FIT study that struck the right balance between functionality and cost. I don’t think we needed a lot of convincing.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
To collect accurate data, each hospital site now completes the FIT CRF for each patient online. The eCRF records patient outcomes including demographics, referral symptoms, family history, drug usage, blood results, investigations and diagnoses.
To protect privacy, data anonymisation is enforced with no names collected and information coded by a patient ID number.
The form is configured to highlight out-of-range, implausible, incorrect or missing data for site staff to resolve at the point of data entry. Many fields are dynamic with ‘show/hide’ form behaviour based on user input (e.g. if you select ‘Yes’ to ‘Change in bowel habit’, further options will appear to elaborate).
York needed users to provide an explicit response to each question (i.e. not responding ‘Yes’ is not an implicit ‘No’; the user must select ‘Yes’ or ‘No’) to minimise the number of queries directed to sites later.
Consequently, most fields are mandatory, ensuring the sites cannot accidentally miss a field leaving it blank. Meanwhile, real-time validation checks safeguard against forms being submitted with invalid data.
When a site submits a new form, an eMail is sent to admin users to alert them and form data is automatically stored ready for export. The admin team will then update a confidential patient log sheet to record that data has been submitted against that patient ID number.
At the same time, the forms are locked with sites no longer able to edit the form or modify the data. However, admin users can edit submitted form data should any corrections be needed. If the original submission contains several mistakes, the site can ask the admin team to delete the original submission and resubmit the form, something that has proved to be quite useful for Monica and her team.
We originally wanted to stop sites duplicating or submitting forms for the same trial number. As study data is locked on submission, ePC suggested it would be quicker to allow it to enable us to minimise admin delays and site monitoring. This advice has been vital as many sites have approached us saying they’ve made errors. Allowing them to resubmit the form has led to fewer queries and saved us time.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
The Trust has access to web dashboards with hospital sites able to view past submissions while admin teams monitor study progress. These dashboards enable admin teams to:
I’m notified when a site submits a form so I’ll login a few times a week to download the data for a particular site and check if I need to query anything with them. When looking at my data, I can select the location, time period and view unsubmitted forms that a hospital site is working on. I really like this feature as I can see what each site is doing and it stops me sending unnecessary eMails.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
In the past, data was unavailable to admin teams for months as sites waited until they had all the information before posting the forms back.
Now, data is available immediately for analysis. Moreover, admin teams can monitor sites as they complete a form, leading to faster query resolution and less people chasing as they can intervene before submission if problems occur.
For the sites, the ability to save a partially completed form and return to it when patient results or diagnosis become available, is invaluable.
I think sites prefer to submit forms electronically as they’re told if they make an error and what they need to fix. It makes their life easier. I find sites login as soon as they’ve consented the patient and complete each section when data becomes available. This doesn’t happen with paper as you can lose it so you’re more likely to wait until you have all the information.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
Moving to electronic forms has eliminated the need for Monica and her team to manually key patient data, resulting in time savings and accelerating data capture. Meanwhile, teams raise fewer queries thanks to data validation rules and checks built into the form.
Prior to adoption, I would spend so much time trying to interpret illegible handwriting or chasing sites for missing data. Now, I have fewer queries and don’t really chase people anymore. This has saved me at least 15 minutes per form, which amounts to a good few hours a week.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
From selecting the cloud-based electronic data capture solution, it took eight weeks for sites to begin submitting data electronically following the design, build and implementation phase.
The implementation has been a smooth process. ePC have been really helpful throughout the project. They were able to offer advice when designing / planning the eCRF and help us iron out challenges before they became major issues. Their advice has really helped us focus on what data we needed to collect in order to meet trial objectives and regulatory requirements. I highly recommend them to other CTU’s seeking to implement an eForms system.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
Additionally, Monica has been impressed with the support available post-implementation.
The support we have received from ePC is fantastic. They are always available, always willing to listen and whenever we have a question, they provide clear and concise answers. Shortly after going live, we noticed an issue with the FIT. On the form, the site must confirm whether the patient has a functional disease in the diagnosis section. If a user selects yes, the form will show multiple options including incidental diverticulosis but the same option was displayed if someone ticked no, so we were recording the same measure in two places. We notified ePC and they responded practically straightaway and provided us with a quick fix to the problem.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
The FIT study is high up on NHS England’s agenda and York have achieved their twin aims of implementing the solution quickly and collecting high quality data in accordance with the study protocol.
I’ve really enjoyed using the EDC software and it has definitely made my life a lot easier. I’ve worked with many electronic data capture systems and some can be really complex. This is just intuitive and really simple. The feedback has been really good. I’ve trained a member of staff at my site and they were really impressed, and they too have used quite a few different systems. It has been really well received and everyone is happy at how user friendly it is.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
The electronic data capture system has saved Monica and her team several hours per week. Over the course of the study, the solution is expected to save York over 165 hours of work.
With eForms, the accuracy and timeliness of data collection has improved immeasurably. This was not possible with paper and means we can begin analysis much quicker to establish if the FIT can accurately detect colorectal cancer in patients.Monica Haritakis, Clinical Trial Manager, York Teaching Hospital NHS Foundation Trust
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