Keele CTU capture accurate data from paper CRF and questionnaires with TeleForm

With an ever-increasing number of paper based clinical trials to operationalise, Keele Clinical Trials Unit (CTU) sought to upgrade its existing TeleForm system to capture accurate data from paper CRF and questionnaires.

Background

Keele Clinical Trials Unit (CTU) specialises in the development and delivery of high-quality multicentre clinical trials, testing treatments and health services, as well as other high-quality clinical studies, including large epidemiological studies, in primary and secondary care settings with the aim of improving patient care.

Over a decade ago, Keele CTU purchased a standalone TeleForm Desktop license to capture patient feedback on paper questionnaires from a large population survey.

Challenge

An increasing number of studies meant that the existing licence no longer provided sufficient throughput as it only allowed one member of staff to concurrently use the system.

Manual data entry

The limited ability to scan or verify data led to a labour-intensive process of manual transcription. When forms were returned, a team of administrators were tasked with manually keying patient data from the paper questionnaires into the study database – an error-prone and laborious process.

Trial database

An internal Microsoft Access based database was developed by the Software Development Team. However, this proved to be hugely time-consuming to pass through build and test, before being released live for end-user manual data entry.

Solution

The administrative burden was growing with pressure mounting on the team to operationalise an ever-increasing number of research studies. With this in mind, Keele CTU prepared a business case and secured funding to upgrade its TeleForm system to realise its full potential.

Jo Smith, Database Interface Manager, Keele CTU explains what happened next:

We did a scoping exercise across a number of UKCRC Registered CTU’s to see what data capture software was in use and by who. During this process, another CTU recommended ePC for support. We decided to contact ePC directly as we knew they were a reputable TeleForm reseller and we wanted to upgrade to a Workgroup licence so we could scan, verify and export simultaneously as well as design new forms.

Securing patient data

ePC installed TeleForm Workgroup on a central university server and migrated existing trial forms, jobs and settings across from the original Desktop set-up to the new Workgroup configuration.

A short time later, Keele CTU established a dedicated secure network with extra firewalls and two-factor authentication (2FA) which was managed independently by their faculty IT staff.

Jo quickly realised an independent network would protect patient data better.

As soon as the secure network was established, we wanted to move our TeleForm set-up over so that it was managed locally by our own IT staff. This meant we could quickly access back-ups if needed while patient data was no longer stored centrally alongside thousands of student records.

ePC spent another day on-site to migrate the system from the university network to the new server as well as configure client PCs and scanners.

Getting everything set-up was pretty straightforward. The migration was perceived as a significant challenge, but it really wasn’t. ePC worked with our IT team to make sure the migration of form templates and datasets from one network to another was seamless. The secure network is very important for the CTU as we are storing patient data. Back in 2016, not every CTU had a dedicated server and it helped to set us further apart from other universities and support our UKCRC registration. We also highlight how patient data is stored on a secure server when we submit an application to the Health Research Authority (HRA) to get a research study approved.

Next, ePC provided a two-day, on-site training course to a core team of administrators who would be designing and coding the forms.

Easy paper CRF design and development

Within the CTU, paper questionnaires and case report forms (CRFs) are the preferred method of data capture as their survey population is generally 60+ and it is thought that the current footprint of this demographic cohort is less likely to be online and comfortable with the technology and security of online systems.

Designing a paper CRF to comply with study protocols and meet regulatory requirements is a lengthy process and requires detailed planning.

Accordingly, the content has to be approved by the Ethics Committee, so early versions are created to enable a multidisciplinary team of academics, trial managers, clinical coders and statisticians to review documents and provide feedback on a range of issues from GDPR compliance to checking the right questions are asked based on the study hypothesis or research question.

Following Ethics Committee approval, final forms are published from the TeleForm Designer and sent to participants recruited into the trial, who are asked to self-complete and post back to Keele CTU.

Jo sought advice from trial statisticians when designing forms

We engage our statisticians early to ensure coding and validation rules for each response on a form are appropriate. They conduct the analysis once the database is locked so it is important to ensure the coding is configured correctly at the beginning. In the long run, it’s much more efficient and helps us improve data integrity and reduce queries later on.

Jo says her colleagues have embraced the TeleForm Designer and welcomed the ability to learn new skills.

We’ve received a lot of positive feedback on the new form designs and how easy it is for non-technical users to design professional templates in TeleForm. You need some basic training but we now have a core team of administrators who can design the forms rather than rely on specialised technical staff.

Additionally, Jo has been impressed with the support available from ePC.

Whenever we build new forms, we always seek ePC’s advice. Their feedback has always been more than the direct question asked. They’ll always say ‘have you considered this…’ or ‘you might want to look at…’ ‘or you might want to change…’. This has been really helpful in terms of ongoing support and the turnaround is always quick.

An added benefit is that Keele CTU now maintains a library of re-usable form templates and field groups to speed up future trial setup.

Fast, accurate data capture from paper CRFs

Once a participant has filled in their form and returned it, it is scanned into TeleForm using a high-speed document scanner.

Next, the handwritten data is read and extracted using OMR, OCR, ICR and barcode recognition technology. The entire process takes seconds with potentially hundreds of forms processed each day.

An integral part of the data management process is verification; to ensure the most accurate ‘clean’ set of data is collected for analysis. If TeleForm is uncertain about a field or character, it is queued for validation before it is exported to the study database.

The data capture is much faster and more accurate. More often than not, forms go through without the need to review them. Any issues are usually related to the design of the form or participants not understanding the question or answering it in a way that was not intended. Many users have said the verification process is not only more accurate, it is less of a chore; they actually enjoy verifying now.

Equally important to the CTU is the ability to maintain quality for the overall study with staff performing QC checks on data exports at regular intervals.

Even now, we still perform a visual check where every tenth form is reviewed field-by-field to confirm the source copy matches what has been entered by someone else and TeleForm facilitates this through its comprehensive QC modes.

Saving time and money

Once verified, data is exported to SQL databases which subsequently facilitates data exports to SPSS for statistical analysis. This is achieved without the need for staff to undertake manual data entry during paper-based clinical trials.

Additionally, Keele CTU is saving money after ending its reliance on the Software Development Team to build ‘data entry’ databases.

Changing habits and increased throughput

Upgrading their old Desktop licence to a Workgroup configuration is reaping the rewards for Keele CTU.

First, Keele has adapted how they process returned forms. Previously, they used to wait until most of the forms had been posted back to the CTU before the mammoth task of manual data entry would begin. Now, someone will scan returned forms at least twice a week as they come in, resulting in much faster data acquisition.

Second, trial teams are no longer limited to a single computer and can access TeleForm from any PC within their local area network and share forms/data between them.

With the old Desktop licence, if the PC was being used to design forms, no one else could scan. Now, there is no bottleneck. If someone is building a new form for a trial currently in setup, another user can log on to another machine to scan and verify returned forms from a live trial.

A successful partnership

ePC deployed the TeleForm-based solution within a highly controlled and secure computing environment with minimum hassle and delay.

Since the rollout, ePC has provided technical support, software maintenance and advice to Jo and her team.

Whenever we ask a question, we always get a response pretty much immediately. Even if ePC cannot fix the problem or answer the question straight away, they’ll come back within a matter of hours with advice or solutions. It’s not just about the technical support though, ePC also provide invaluable feedback on improving form templates or advice on implementing scripts on forms.

Results

Since the implementation, Keele CTU has used TeleForm to collect accurate data across multiple paper trials. Currently, there are six live studies with three in setup. Furthermore, at least half a dozen studies have finished recruiting trial participants.

Critically, TeleForm has saved Jo and her team many hours.

Looking ahead, Jo anticipates Keele CTU will track user activity which will facilitate a more accurate ‘time to process’. Not only will this help to provide clearer detail on how much time and resource is saved by TeleForm, but will also help to inform accurate data entry costings.

We know the throughput is quicker based on the amount of time it took prior to purchasing TeleForm. In the future, we plan to quantify these time savings against a non-TeleForm research study.