Dr. Paul Constable is a Senior Lecturer at Flinders University College of Nursing and Health Sciences in Adelaide, South Australia. After obtaining his PhD at City University of London and working in London for nearly 25 years, he joined Flinders to return to academic research.

Early in 2020, Dr. Constable set out to study whether the retina is more or less sensitive to light in young children where there is some evidence of autism and further neurodevelopmental delay.

As he prepared for his latest study, Dr. Constable had a very real problem: He had no participant database to pull potential study participants from and no patients of his own to invite to the trial.

After taking some traditional recruitment routes to no avail, he knew he needed to try something new. There was a lot on the line – not only the results of the study but also filling the need for a robust database of local participants and ultimately making a positive impact on autism research progress as a whole.

Establishing a Clinical Baseline

Much of Dr. Constable’s work these days surrounds a newly-developed device that measures the retinas’ response to light.

“The device is non-invasive – it’s essentially a handheld torch which flashes light. You place an electrode just below the child’s eye,” he explains. “We pick up signals with the electrode from the photoreceptors and bipolar cells [in the eye].”

“From the first study, we were able to identify flash strengths or brightnesses that gave the best resolution to identify children with autism and those without.”

Dr. Constable’s initial study of children aged 5-16 years old found that children with autism had some differences in their responses.

“The retina responds to light, and we can record different signals from the retina as it responds. Those signals are modified by neurotransmitters in the retina which are the same neurotransmitters in the brain. So if the brain’s neurochemistry is imbalanced, then, we can often find differences in the retina’s responses. This method gives us an insight into the brain via the retina”

With his background in studying autism and Autism Spectrum Disorder (ASD), Dr. Constable wanted to learn more about how this device could help doctors.

“We’d like to try to use this test to help identify children with altered neural signalling such as in autism at an earlier age,” he says.

To do that, he’d need to establish a baseline of healthy children with no immediate family history or documentation of known neurodevelopmental issues. The Healthy Children (Control) Study was the path to further studies.

The First Signs of Study Recruitment Trouble

Having recently relocated from London to Adelaide, South Australia, Dr. Constable didn’t have much to work with. There was no database of patients to begin the study.

“I was lucky enough to get some research funding to do the study but had no study population that I could turn to. And so it was really important to be able to get a very good range of participants from different backgrounds as well as children with a diagnosis of autism,” he recalls. “The goal, really, was to establish a sort of one-off big data set.”

Dr. Constable had to adjust his expectations – he was used to having a robust database while working in London – or at least a process for building or adding to a database. Neither existed with any real consistency at the time at Flinders among researchers.

“Even for me to say to someone, ‘Do you have a group of people I could contact,’ they would say, ‘Oh, we just go to schools’ or do something similar. There wasn’t a real repository for researchers to tap into which I was a bit surprised about.”

Getting the Word Out… but with Little Recruitment Success

Discovering there was no database to turn to, Dr. Constable began using the methods he knew to be at least somewhat successful: asking around, telling others about his study, and publishing public information.

“I did some advertising on Autism SA’s webpage for recruits and got no one – no queries or enrollments. I also talked with some colleagues. Those researchers were doing some autism research but they didn’t really seem to have the age group I was after or the kind of sophisticated database that I was looking for.”

Dr. Paul Constable, Senior Lecturer
Flinders University, Caring Futures Institute

“When parents came into the clinic, I would say we were still looking for children who might be interested in participating. That was the main way of doing it,” he says.

“I also talked with some colleagues in the disabilities department. Those researchers were doing some autism research but they didn’t really seem to have the age group I was after or any large database of participants to tap into.”

Dr. Constable tried  “some advertising on Autism SA’s webpage for recruits but alas, this didn’t provide any queries or enrollments.”

It didn’t take him long to realize he needed help.

Considering the Risks (and Rewards) of Outsourcing Recruitment

Having never needed to work with a recruiting outsourcing company before, Dr. Constable had some reservations.

“It was a leap into the unknown – I had never needed to go out and use another company. In the UK, it was very much word-of-mouth advertising and having people come into the control population.”

Like many researchers, his concerns were about spending his limited funding and seeing no results.

“I was worried I wouldn’t get enough subjects and I wasn’t too sure how things would go. I also think being in Adelaide compared to London – I was worried about recruiting in a smaller city,” he says.

Giving a New Recruitment Process a Try

With no ideas on where to turn next on his own, Dr. Constable first spoke with Trialfacts in January of 2020 just before the news of the global pandemic broke. Thankfully, the repercussions of COVID-19 didn’t have much effect on the study’s recruitment or ongoing progress.

Trialfacts provides in-depth spreadsheets that are updated in real-time with detailed information on each potential participant.

The Trialfacts process streamlined Dr. Constable’s recruitment and delivered potential participant leads through detailed referral spreadsheets. In no time at all, he was seeing more recruits and inquiries than he’d expected.

“We recruited about 30 ASD and 30 non-autistic children for the first study and that gave me a boost of confidence.”

The prescreening data collected from Trialfacts also helped Dr. Constable personalize his conversations during the phone screening process.

“The Excel spreadsheets were great to get a lot of background information. The parents’ comments were there so before I called them, I would know more about them and we would have something to talk about.”

Dr. Paul Constable, Senior Lecturer
Flinders University, Caring Futures Institute

“The Excel spreadsheets were great to get a lot of background information. The parents’ comments were there so before I called them, I would know more about them and we would have something to talk about,” he says.

Reaping the Benefits of Outsourcing Recruitment

Overall, participant recruitment was a major success and exceeded Dr. Constable’s expectations: The study set out with a goal of recruiting just 80 participants but in the end, 124 participants were enrolled. Thanks to his 155% enrollment rate, the recruited population resulted in a much more diverse and robust sample for his research.

“It went really well. It was very much a snowballing effect – I think that’s the right word in research. It was worth spending what we did because it saved my time. It was deciding, ‘I’m not going to spend 5 hours or a weeks’ worth of hours on the phone all day long.’”

Dr. Paul Constable, Senior Lecturer
Flinders University, Caring Futures Institute

“It went really well. It was very much a snowballing effect –. Once one parent had brought their child in they were happy to pass on information about the study to other parents and the snowball kept growing”.

“We now have a contact database and can reach out to them to the participants and tell them about the results of the study and potentially bring them back again to do further studies.

We build a personalized recruitment funnel for each study to ensure you are able to hit your enrollment goals on-time and within budget.

“There was also a broad range of children from different backgrounds, which is what you want – that cross-section of the population in the control group,” he shares. “It was really important to be able to use Trialfacts’ reach to get a very good range of participants from different backgrounds as well as individuals with a diagnosis of autism.”

And despite his concern over spending money and seeing no returns, Dr. Constable realized his decision to outsource recruiting saved him precious time and energy.

“I think when you look at the cost, it was a reasonable cost in terms of my time or Trialfacts’ knowledge doing recruitment. The pricing structure was very good and attractive,” he says.

“It was worth spending what we did because it saved my time. It was deciding, ‘I’m not going to spend 5 hours or a weeks’ worth of hours on the phone all day long.’”

Dr. Constable also appreciated removing the emotion from the process. “It was a lot slicker and easier to distance yourself from recruitment as well. There wasn’t that sort of personal academic asking, ‘Please come and do this work for me.’ With Trialfacts, the person making the first contact isn’t me – it’s Trialfacts. And then participants are directed to the questionnaire and we later have a chat and go from there. It removes that pressure and you’re not going to get that biased academic population, either.”

“It was nice having people voluntarily opting in or expressing interest in the study. That was an advantage,” he concludes.

After potential participants and their guardians would reach out, Dr. Constable would send a short, detailed information sheet to help prepare participants for the study. More then 70% of participants reviewed the information sheet.

Furthering the Research

Ultimately, Dr. Constable hopes to help pediatricians diagnose developmental issues in children at an earlier age.

“This is the expansion trial – we’ve recruited an extra group of children under the age of 5 to do the same clinical tests as our current study. The next step is to ask pediatricians at the Flinders Medical Center to run these clinical tests as part of their diagnostic procedure for children who are assessing language delay or developmental behavior problems and see if this test can help identify children that may have a neurodevelpmental condition that the test can help with either earlier diagnosis or management.”

The study is ongoing, but Dr. Constable has learned a lot about streamlining the recruitment process.

To help educate potential participants about the study, he would send a brief but informative flyer to them via email. Parents read the sheet before the initial contact call about 60-70% of the time and it helped to move the conversation along.

Dr. Constable attributes the success of his information sheet to its briefness. It included pictures of the device used for the study so parents and child participants would have a clear idea of what to expect.

As for what he’d do differently if he was starting again, he says he would have shared this information sooner. There was a significant difference in the onboarding process once Dr. Constable began sending the information sheet prior to the first call.

“It was much easier because the parents and their children had a chance to look at it. And it was nice for us to also make that ‘touch,’ I guess, to say thanks for their interest and share a bit more information about the study,” he says.

The next steps are to see how we can use the retina’s response to light to help us understand neurodevelopmental conditions.