and informed consent

The case for using anonymised clinical data wasn't explained clearly enough by NHS England; the result was the failure of a scheme that would have benefitted all.

Mobile web-based clinical trials become a possibility.

A number of recent innovations disparate areas of technology are being brought together for the first time to make mobile, web based clinical trials practical.

Cognoa and the Dr Google Epidemic

A new app targeting worried parents of autistic children should be treated with caution.

New clinical trial mobile technology.

A new way to manage stakeholder engagement in clinical trials

Clinical Technologist

A Blog Dedicated To The Interaction Of Information Technology And The Field Of Medicine.

Saturday, 13 February 2016

Mobile Based Remote Clinical Trials Now a Realistic Option

Web-based remote trials have been in use since 2014.  

The format replicates clinic based trials. A central clinical site oversees a process which:
  • Recruits participants over the web through questionnaire based selection.
  • Obtains informed consent using web-based methods, countersigned by a local physician.
  • Conducts lab testing in each community.
  • Monitors and collects results by self-reporting through a web-portal.
One of the main benefits of this approach is in patient recruitment. Traditional challenges to selecting a patient group, including minimising selection bias, establishing a representative group and establishing a suitably large sample size are helped by web selection. Candidates can be identified through arrival at niche websites which rank highly in search engines for keywords linked to the condition. A wider group of clinicians can be canvased through email and clinical portals. Online Support Groups can also be approached.

Groups approached in this way have been shown to be more positive about being involved in clinical trials; they are also more informed, which mitigates against low health-literacy in obtaining informed consent.

A number of recent innovations can now build on this success.

Automatic Data Collection in Remote Clinical Trails

The first is the use of disposable biosensors, which can automatically collect data and send it through a mobile or wearable device to a central server.  Such data collection can increase the resolution of the data, help avoid gaps and provide quantifiable data in near real time.  The technology is often  unobtrusive, which further improves compliance. 

Improved Safety in Remote Clinical Trials

Not only does this improve the datasets available to the trial, it also provides significant safety benefits.  Formerly data was entered on paper and faxed to the clinical team. Recently this has improved through uploading the data, but this still involves offline collection and periodic submission.

This all changes when automatic data collection is through a mobile online device.  Data is now reported in real time which allows faster analysis.  This may allow for early indications of problems with the trial drug which may warrant intervention.  It also allows clinicians to monitor adverse reactions in patients as soon as they occur.  Qualitative data can also be added by the patient in real time, including diary information and an alerting function to report severe events.

A further benefit is the opportunity to connect with the patient's support network during the trial. Most patients will share information with someone during the trial. Mobile technology allows that person to have a connection with the clinician.

Leveraging Diverse Datasets in Remote Clinical Trails

The use of mobile data linked with analytics opens up further opportunities for innovation. With consent, rich meta-data about the patients environment can be collected.  Ambient temperature and GPS location can be linked to widely available weather datasets, eg to give an estimate of air quality at the patients location. In other industries major benefits have been realised by joining disparate datasets in this way; the technique may well benefit clinical trials similarly. 

Remote Clinical Trial Coordination

A final benefit of combining these technologies is in the coordination of the trial team.  By building a more dispersed trial set, it's likely that more clinicians will be involved.  Social collaboration tools set up specifically and securely for the trial can assist in the coordination of all involved, the dissemination of information  and a route back for both two way and many-to-many discussions.  Having these coordination tools installed on tablets also allows for the input of clinicians who typically move between sites or hospitals.

By combining the use of disposable biosensors, wearable technology, mobile devices and social collaboration tools, clinical trials could greatly increase their ability to collect high quality data while improving trial safety.  Moreover, and for the first time, such technology can be deployed at reasonable cost. 

Tuesday, 2 February 2016

New Clinical Trial Mobile Technology

Gather™ offers the industry a new way to manage stakeholder engagement in clinical trials and is designed to connect the traditionally independent technology systems used in clinical trials today. The product suite offers end-to-end engagement for all participants in clinical studies, from design through to completion.

Gather - Exco In Touch

There is a different way to manage clinical trials. The most important assets in clinical development are people. It's by understanding and living in their world - and taking great care of them - that we gain the participation and insight we need to create the best medicines and treatments.

Saturday, 17 May 2014 Didn't Care Enough

It’s clear that both doctors and patients are becoming more aware of what good communication means, and how important it is.  Add this to a desire to communicate in more rapid, perhaps informal way, and you have fertile ground to bring in new IT systems to support exactly that.

It's bewildering to many GPs in England, then, that the new healthcare data system got it so badly wrong.  And it fouled up on the most basic medical principle; informed consent.

New technology continues to enable communication but brings additional risks. Take the case of NHSEngland’s ‘’, a national database linking all patient datasets. Well-publicised data entry errors and poor communication to doctors, clinicians and the public are raising concerns in how information is to be used. In a recent poll 41% of GPs in England were intending to opt-out of the next data-sweep, while a recent NHSEngland information leaflet was itself condemned for being unclear.

So the rebrand of is now well underway.  It's yet to be seen how many of the straight forward issues will be altered.  No doubt the marketing agency has been fired; there will be a new leaflet with opt-in as default, and a clearer information design.

However, will there be a change to the fundamental problem that plagued the first attempted launch? That of gaining informed consent?

According to a recent mori poll, when the benefits of are clearly put, and the personal risk explained many change their position and become supporters.  It's hard to stand against a system that will save lives, and may save you're own one to boot. The main concern that the data will be used commercially is factually wrong, and was never the case.  But that case was never properly explained.

The medical profession have informed consent at it's core.  Marketing and Information Systems Design does not. It's time the latter started to understand the former, their customers.

Monday, 21 April 2014

Cognoa and the Dr Google Epidemic

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A new app aimed at helping parents who suspect their child is suffering from Autistic Spectrum Disorder has been announced. The app, Cognoa, offers to analyze the risk to the child's development based on a 2 minute video and a short parental questionnaire.

The CEO behind the app, Brent Vaughan, quotes the CDC, the US body responsible for disease control, that the number of cases of Autism has risen by 30% since 2010. The incidence of Autism is now 1 in 68 in the US, with 1 in 5 being diagnosed with learning difficulties.

At face value this app appears to be worthwhile. +TechCrunch mentions that it joins with the likes of Neurotrack, an automated cognitive test to which aims to predict the onset of Alzheimer’s Disease, as part of a new batch of startups which mash-up analytics, growth hacking and healthcare practice.

If this were a software package for clinicians, then that may well be fair. However, it's not. This is an app aimed at worried parents. That changes everything.

Post Hoc Ergo Propter Hoc, Doc

In the early April 14 BMJ, Michael McCarthy also quotes the CDC's findings. He highlights that the increase in diagnoses comes not from an increase in Autism rates but the widening of the diagnosis into a spectrum of disorders. This has led to more children with higher IQs and fewer symptoms being diagnosed with ASD.

So does this new app help parents caught up in a growing problem, or is it adding to the problem itself?

Apps Do Not Make Good Clinicians

The diagnosis of ASD is a complex process. Named ADOS (Autistic Diagnostic Observation Schedule), it involves a highly structured 1 hour interview designed to draw out the subtle signs of Autism and the video analysis of at least an hour’s worth of play by the child. Such is the complexity, three separate healthcare professionals are needed. First of all they analyze the data in private, then write down their diagnoses before coming together to compare notes and come to a common position.

The reason for this extended process is the complexity and subtlety of ASD. This is one area where following a prescriptive diagnostic flow-chart is simply impossible. Moreover, a misdiagnosis can be highly damaging; it may lead to inappropriate medicalization for a child at the extreme end of normal behavior and the labeling of that child in their own mind, in their parents and at their school.
Diagnosing ASD in children has added difficulties. Their stage of development and social context always play a factor. It's therefore reasonable to take extreme care in the assessment.

Providing an App for parents to jump in early on this process is highly inappropriate. Although the makers stress that the app is to assess risk, not diagnose, such a nicety is for research papers and not distraught parents. Inevitably it will lead to the parents forming a premature view.

Even if the App get’s it right, the child still needs formal assessment. But if it gets it wrong, a false-positive can lead to inappropriate worry for the parents, and insistence on treatment if the doctor they’re referred to does not agree, or a false-negative can lead to a child not being treated at all.

Dr Google Will See You Now

It’s also part of a wider trend reported in the BMJ as ‘Dr Google’. In a single blind study, Google proved to provide accurate medical information only 58% of the time. Nevertheless the use of Google to self-diagnose is on the increase.

To some extents that’s to be expected – people worry and seek information. But if it’s condoned by the medical profession it can seriously hamper the care that’s received, and tie up resources in the ‘worried-well’.

Whether Cognoa will follow this trend or pivot to a software package available to healthcare clinicians has yet to be seen. Currently, they are marketing directly to parents. As clinicians themselves they should perhaps stop and reconsider; Dr Google may well have a part to play in diagnosing a cold, or a broken arm, but has no place in complex, multifaceted disorders.