Taking Action

The Role of Technology in Clinical Trials

Oct 31, 2017
Taking Action

Dear Diary,

I have been struggling with an eating disorder for the past few years. I am afraid to eat and afraid I will gain weight. The fear is unjustified as I was never overweight. I have weighed the same since I was 12 years old, and I am currently nearing my 25th birthday. Yet, when I see my reflection, I see somebody who is much larger than reality.

I told my therapist that I thought I was fat. She said it was 'body dysmorphia'.
She explained this as a mental health condition where a person is apprehensive about their appearance and suggested I visit a nutritionist. She also told me that this condition was associated with other anxiety disorders and eating disorders. I did not understand what she was saying as I was in denial; I had a problem, to begin with. I wanted a solution without having to address my issues.

Upon visiting my nutritionist, he conducted an in-body scan and told me my body weight was dangerously low.

I disagreed with him.

I felt he was speaking about a different person than the person I saw in the mirror. I felt like the elephant in the room- both literally and figuratively. He then made the simple but revolutionary suggestion to keep a food diary to track what I was eating.

This was a clever way for my nutritionist and me to be on the same page. By recording all my meals, drinks, and snacks, I was able to see what I was eating versus what I was supposed to be eating. Keeping a meal diary was a powerful and non-invasive way for my nutritionist to walk in my shoes for a specific time and understand my eating (and thinking) habits.

No other methodology would have allowed my nutritionist to capture so much contextual and behavioural information on my eating patterns other than a daily detailed food diary.
However, by using a paper and pen, I often forgot (or intentionally did not enter my food entries) as I felt guilty reading what I had eaten or that I had eaten at all.

I also did not have the visual flexibility to express myself through using photos, videos, voice recordings, and screen recordings. The usage of multiple media sources would have allowed my nutritionist to observe my behaviour in real-time and gain a holistic view of my physical and emotional needs.

I confessed to my therapist my deliberate dishonesty in completing the physical food diary and why I had been reluctant to participate in the exercise. My therapist then suggested to my nutritionist and me to transition to a mobile diary study.

Whilst I used a physical diary (paper and pen), a mobile diary study app would have helped my nutritionist and me reach a common ground (and to be on the same page) sooner rather than later.

As a millennial, I wanted to feel like journaling was as easy as Tweeting or posting a picture on Instagram. But at the same time, I wanted to know that the information I  provided in a digital diary would be as safe and private as it would have been as my handwritten diary locked in my bedroom cabinet.

Further, a digital food diary study platform with push notifications would have served as a constant reminder to log in my food entries as I constantly check my phone. It would have also made the task of writing a food diary less momentous by transforming my journaling into micro-journaling by allowing me to enter one bite at a time rather than the whole day's worth of meals at once.

Mainly, the digital food diary could help collect the evidence that I was not the elephant in the room, but rather that the elephant in the room was my denied eating disorder.

Sincerely,
The elephant in the room

In the past 20 years or so, technology has improved significantly-- to the point where it is practically the center of our lives. Whether it is our phones, or our computers, technology has taken over what we do in our day to day. As a result, it is no surprise so many fields of study have adapted to this advance in technology. Slowly, more and more pen-and-paper processes are shifting to the electronic approach. Many, however, remain in the old-school method. Areas like clinical research are reluctant to change and stick to pen-and-paper, saying the new methods are time consuming and more expensive since they require larger teams and tend to cover greater audiences.


There are many problems, however, with paper-based data capture. For instance, given that the data gathered by researchers is very large, since they must cover sufficient samples for it to be statistically viable and appropriate to analyze, the work and time they spend transcribing these is also huge. This is the major difficulty that comes the analog way. Furthermore, with paper CRFs it becomes overwhelming to check for data accuracy in so many physical sheets. This makes EDC tools much more advantageous and makes these results more manageable. In addition, the time spent learning the software is not much compared to the time researchers spend trying to work with analog data. Less time spent equals to less money spent overall, making EDC a better option.

Researchers' opinions on EDC vs. paper CRFs

Other researchers have replaced EDC softwares with regular spreadsheets. This option is still much better than paper surveys, but presented against EDC they still remain insufficient. A study conducted by the Harvard Medical School suggests regular spreadsheets are slower than web-based electronic data capture. EDC softwares are clearly a better option, it’s what they are for. According to the “Pros and Cons of EDC” by Rebecca Kush It cuts the “timeline from 4-8 weeks to a matter of hours” and reduce data by 70%-80%.(1) Web-based EDC were the first, but they have gradually evolved to phone applications as well. While the web-based version is the most popular, mobile applications are quickly taking over, given their easy accessibility and user-friendly interface.(3)

Technology has helped improve many aspects of our lives, and the research fields are not far behind. Although many researchers keep using paper-based method data collection for their studies, the great majority have appreciated the benefits of electronically-based methods, such as efficiency, and less money spent overall. EDC tools have proven their superiority and are taking the lead in the field.

Sources

  1. https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf
  2. https://www.worldwide.com/blog/2017/04/electronic-data-capture-early-phase-clinical-research-still-unlikely-pair/
  3. http://www.jmir.org/2016/6/e141/
  4. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1674-9
  5. http://www.appliedclinicaltrialsonline.com/ecoa-and-epro-provide-accuracy-data-capture
  6. https://www.slideshare.net/crystalhuntergtcbio/the-expanding-eclinical-universe-streamlining-progress-by-changing-current-work-processes-and-moving-away-from-paper-alan-s-louie-phd-research-director-idc-health-insights

If appropriately used in the 21st century, data could save us from lots of failed interventions and enable us to provide evidence-based solutions towards tackling malaria globally. This is also part of what makes the ALMA scorecard generated by the African Leaders Malaria Alliance an essential tool for tracking malaria intervention globally.

If we are able to know the financial resources deployed to fight malaria in an endemic country and equate it to the coverage and impact, it would be easier to strengthen accountability for malaria control and also track progress in malaria elimination across the continent of Africa and beyond.

Odinaka Kingsley Obeta

West African Lead, ALMA Youth Advisory Council/Zero Malaria Champion

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Dear Digital Diary,

I realized that there is an unquestionable comfort in being misunderstood. For to be understood, one must peel off all the emotional layers and be exposed.

This requires both vulnerability and strength. I guess by using a physical diary (a paper and a pen), I never felt like what I was saying was analyzed or judged. But I also never thought I was understood.

Paper does not talk back.Using a daily digital diary has required emotional strength. It has required the need to trust and the need to provide information to be helped and understood.

Using a daily diary has needed less time and effort than a physical diary as I am prompted to interact through mobile notifications. I also no longer relay information from memory, but rather the medical or personal insights I enter are real-time behaviours and experiences.

The interaction is more organic. I also must confess this technology has allowed me to see patterns in my behaviour that I would have otherwise never noticed. I trust that the data I enter is safe as it is password protected. I also trust that I am safe because my doctor and nutritionist can view my records in real-time.

Also, with the data entered being more objective and diverse through pictures and voice recordings, my treatment plan has been better suited to my needs.

Sincerely,
No more elephants in this room

Connie Cornejo's profile picture

Connie Cornejo

Marketing Manager at Teamscope

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