Global coverage. One platform of choice.
Spiral came on board as the software partner of choice for the TAME trial over five years ago.
Since then, we've supported the team to take their multicentre randomised control trial to 63 sites in 17 countries. We speak with Dr Glenn Eastwood, TAME Chief Principal Investigator, about the study and how Spiral has enabled them to produce a database they can be confident in. Alongside TAME, Dr Eastwood is a Senior Research Fellow at the Australia New Zealand Intensive Care Research Centre within Monash University.
The TAME trial study compares the targeting of normal arterial carbon dioxide levels to slightly higher than normal carbon dioxide levels for 24 hours in patients admitted to the ICU following cardiac arrest in the community. The research seeks to discover if leveraging off the neuroprotective anti-inflammatory and increasing blood flow effects of having slightly higher carbon dioxide levels in the blood improves the neurological outcome of patients who survive to six months.
Design thinking that embeds multiple comparative data.
Spiral's software has allowed him to have confidence in the quality of the wealth of information collected in the TAME trial, as the layout and structure of the software makes it so user-friendly.
"As a Research Manager and Coordinator at Austin Hospital, I had been a user of the Spiral data management system for previous trials and felt supported by their team. I was impressed with its user-friendliness and good layout, so when it came time for me to choose a trial platform for TAME to run on, I immediately put forward Spiral. I was confident they could expand into other countries with us."
This study was also unique because it was a harmonised trial embedded in a two by two factorial design. Under serendipitous timing, the TTM2 trials were looking for funding simultaneously as us but were looking at temperature management for patients after cardiac arrest. By embedding one trial database and one case report form, the Spiral platform allows sites to do one or both trials, allowing both trials better access and site leverage.
The final participants were recruited in September 2021, and their 6-month follow-ups with trial participants were completed in February, aligned with their initial projections of completion all those years ago.
Whilst the pandemic could have been a spanner in the works, as different countries came on board at various stages, certain sites could enrol patients when others were not, and vice versa. Now, the team are focused on getting all their data into Spinnaker, and we eagerly await the study's findings, which are expected to be released later this year.
Ensuring that each of the 65 sites taking part in the trial had a good user experience was essential to this study. Dr Eastwood acknowledges this is one of Spiral's greatest strengths, with the software applying common sense with logical and chronological tabs and inputs.
He also notes that the design's attention to detail provided exceptional ease of use, as he could source the correct information quickly and accurately.
"The database field has a prefix that corresponds with the case report form, and that abbreviation is so important for investigators because I want easy access to that variable on that particular row of that table in a paper. Details like that were a blessing."
This attention to detail extends further, allowing for the use of different units of measurement. Some sites this trial was running at used millimetres of mercury as a unit of measure, and others used kilopascals. Ensuring that clinicians were able to input their data in a way that made sense to them meant that the users didn't have to do more calculations than necessary, and the database took care of the rest.
"No matter where you were, you're able to tailor the data coming into the database to suit the site."
Dr Eastwood acknowledges the ease of working with the Spiral team, which allows him to focus on his area of expertise. Not only has he found the software reliable and built for purpose, but the simple contract for build and clear monthly maintenance fee have been helpful and reassuring when budgeting research funding.
Motivated by human compassion.
This research has been ten years in the making, and it's easy to see that Dr Eastwood's motivation is human compassion. He sees his role as nudging care, little by little, to make improvements in patient outcomes and wants people to be able to hug their kids and enjoy a new part of their life that they might not get otherwise.
He acknowledges that the Spinnaker database allows them to record information to make it easy to turn it into clinical language for their clinicians. This is one of the ways that this study has had participation across so many sites with ease.
Moving into the future, data security and data protection are amongst the top priorities of policymakers, particularly in the countries where TAME has operated. Dr Eastwood is grateful for Audrey and the Spiral team's assistance in answering the questions about the Spiral software, with a clear understanding of the ins and outs of their data processes and policy adherence. He acknowledges that systems like Spiral's that are clear on these requirements will become more important as the research community continues to evolve in a connected world.
"Spiral provides a monthly update about the security, the firewall and the system had rarely had any downtime which was reassuring as the trial all around the world and the clinicians taking part needed access around the clock."
"Products that help facilitate clinical research, like Spinnaker, are just going to get more and more important because there's so much data out there and so much opportunity to bring this data together to help create better patient outcomes. I've seen Spiral's flexibility and adaptability and am excited to see how they evolve."