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Date: October 24, 2022

Guest Skeptic: Dr. Damian Roland is a Consultant at the University of Leicester NHS Trust and Honorary Professor for the University of Leicester’s SAPPHIRE group. He specializes in Pediatric Emergency Medicine and is a passionate believer and advocate of FOAMed. Damian is also part of the Don’t Forget the Bubbles team.

Dr. Damian Roland

I sent Damian a message on Twitter after he posted about his pre-print paper, “Concomitant infection of COVID19 & Serious Bacterial infection in Infants <90 Days Old during Omicron Surge.”  It was a rapid evaluation under the remit of the Public Health/Disease Control so did not require review by a Research Ethics Committee (REC). Unfortunately, journals, do not typically accept this and want to see ethics derogation. This led to a conversation about research ethics and governance.

It is important to acknowledge that historically, the medical community has not always conducted research ethically. We took advantage of vulnerable and minority populations as evidenced by Nazi medical experimentation in the concentration camps, the Tuskegee Syphilis Study, or the HeLa cells of Henrietta Lacks. We recognize the importance of research oversight and ethical research, but our world is changing…

How have emerging pandemics, technology, and social media impacted the way we conduct and disseminate research?

We covered five topics:

  1. Ethics of Research in Pandemics
  2. Maintaining Research Quality
  3. Deferred Consent
  4. Big Data
  5. Sharing Research on Social Media

Ethics of Research in Pandemics

Many processes that govern research were scaled back to enable rapid translation of ideas. Some of this was good (ex. steroids in Covid, vaccines) but some had some potentially detrimental consequences (think pre-prints) [1].

It was much easier (in the UK) to access national data sets, and this enabled real-time research to take place. During pandemics, we need to be nimble but governed when conducting research. For example, when a new disease process (ex. PIMS TS or MIS-C) is of such a public health importance that we need to understand it as fast as possible, it is difficult to do so under stringent ethics and governance practices. For the next pandemic, we need to have systems in place for research studies to be pre-approved and ready to go as soon as a pandemic hits.

Maintaining Research Quality

At one point there were over 100 articles being published per day about COVID-19 [2]. Not all of them were useful or high quality. Keep in mind the words of Professor Altman, “we need less research, better research, and research done for the right reasons.”[3]

It is possible to have well-governed research that is poor quality but finds itself through poor review, disseminated widely in a high-quality journal. Conversely, there can be well-governed research that is high-quality, but journals disagree, and that research has less impact because it is not perceived by journals to be good.

The issue of ethical review should be separate from quality and governance. Does ethical review encompass the standard or quality of research or the mechanism of ensuring that the research is ethically performed? A randomized control trial is always going to have ethical review whereas an observational study may not. Should research that is well thought out and robust but lacking ethical approval be excluded from journals because editors perceive it does not meet the standard for high-quality research?

We separated 1) the governance of conducting research 2) the process of research, and 3) the publication of research and 4) the application of research findings.

There are many factors that come into in play when making clinical decisions while facing the pressures of a novel pandemic. Dr. Simon Carley on SGEM Xtra: EBM and the Changingman discussed his publication, Evidence-based medicine and COVID-19: what to believe and when to change. [4]

Deferred Consent

This is not a new concept but has been historically difficult to get through an ethics committee. We have seen this with seizure studies such as Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children (EcLiPSE)[5] and Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT)[6]. Parents did not want to have the burden of consenting to a study during a stressful time, so these patients were randomized and consent was obtained later. Most of the hesitation about this approach did not come from the patients or parents but the clinicians. These studies are now a couple of years old, but deferred consent is being increasingly used in a variety of pediatric studies. Should deferred consent become the standard?

Some still think that consent should be obtained prior, if possible, out of respect for patient autonomy and principle of respect for persons. Maybe there are exceptional circumstances when deferred consent is appropriate such as situations where there is clinical equipoise, and the patient is in critical condition or unable to provide consent [7]. When we are conducting research on pediatric patients, we are often obtaining consent from the legal guardians and assent from the child (if possible). We are relying on a proxy consent which may or may not align with the preferences of the patient [8].

In the UK, there is patient and public involvement (PPI) with studies so that research becomes a collaboration between researchers and patients, including children right from the beginning. This is critical as patient/family values and preferences is one of the pillars of evidence-based medicine.

Big Data

The recently published EPISODES study (Presentations of children to emergency departments across Europe and the COVID-19 pandemic: A multinational observational study | PLOS Medicine) [9] highlights the power of bringing multiple hospitals together. This is an opportunity to standardize reporting outcomes and comparing them in reliable and objective ways to see how care is provided globally.

There are many global emergency medicine research networks. The results from these multi-center studies may be more generalizable. However, we should still be applying a critical and skeptical lens to these studies as disease prevalence and phenotypes may vary depending on location. We still need to determine whether the findings from big data studies can be applied to the local population.

Sharing Research Findings via Social Media

COVID-19 saw some savage attacks by scientists on each other which probably detracted from the original research (and obscured good papers and falsely elevated poor ones). There can be various interpretations of the evidence. Scientists are realizing that social media is a great mechanism for knowledge dissemination and translation.

We need to be wary of crowdsourcing “facts” [10]. We enjoy being around like-minded people so it is easy to create communities in social media that are echo chambers. Confronting a perspective different from our own is uncomfortable. It is possible to have a civil conversation or debate and still disagree without being unkind to one another. It’s okay to change our minds! People were critical of health organizations changing recommendations during the pandemic, but that’s science!

Damian encouraged us to maintain a professional tone and try to be objective as we can when sharing information on social media, acknowledge when we are wrong, and admit when we do not know.

 

The SGEM will be back next episode doing a structured critical appraisal of a recent publication. Trying to cut the knowledge translation window down from over 10 years to less than 1 year using the power of social media. Our goal is for patients to get the best care, based on the best evidence.

Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

References:

  1. Nabavi Nouri S, Cohen YA, Madhavan MV, Slomka PJ, Iskandrian AE, Einstein AJ. Preprint manuscripts and servers in the era of coronavirus disease 2019. J Eval Clin Pract. 2021;27(1):16-21.
  2. Teixeira da Silva JA, Tsigaris P, Erfanmanesh M. Publishing volumes in major databases related to Covid-19. Scientometrics. 2021;126(1):831-842.
  3. Altman DG. The scandal of poor medical research. BMJ. 1994;308(6924):283-284.
  4. Carley S, Horner D, Body R, Mackway-Jones K. Evidence-based medicine and COVID-19: what to believe and when to change. Emerg Med J. 2020;37(9):572-575.
  5. Woolfall K, Roper L, Humphreys A, et al. Enhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (Peruki) study. Trials. 2019;20(1):181.
  6. Dalziel SR, Borland ML, Furyk J, et al. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (Consept): an open-label, multicentre, randomised controlled trial. Lancet. 2019;393(10186):2135-2145.
  7. McRae AD, Weijer C. Lessons from everyday lives: a moral justification for acute care research. Crit Care Med. 2002;30(5):1146-1151.
  8. Jansen TC, Kompanje EJO, Druml C, Menon DK, Wiedermann CJ, Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med. 2007;33(5):894-900.
  9. Nijman RG, Honeyford K, Farrugia R, et al. Presentations of children to emergency departments across Europe and the COVID-19 pandemic: A multinational observational study. PLoS Med. 2022;19(8):e1003974.
  10. Baron RJ, Ejnes YD. Physicians spreading misinformation on social media – do right and wrong answers still exist in medicine? N Engl J Med. 2022;387(1):1-3.