The development of living guidelines for treating COVID-19 is vital to ensure that clinicians can provide the best quality care to their patients, but more Australian research is needed.
A senior clinician has spoken of the difficulty of producing living guidelines to treat patients with coronavirus disease 2019 (COVID-19) in Australia.
The emergence of new variants, the increase in vaccination rates, and the reduction in the number of people needing hospitalisation, all impact the ability of researchers trying to develop living guidelines for treating COVID-19.
Associate Professor Bridget Barber and her colleagues highlight these complexities in a new Perspective article published in The Medical Journal of Australia today.
“One of real difficulties of developing living guidelines is that the landscape of the pandemic has changed so substantially since the earlier studies evaluating treatments for COVID-19 were published,” Associate Professor Barber told InSight+.
Associate Professor Barber is a Senior Research Fellow at QIMR Berghofer and an infectious diseases physician at Royal Brisbane and Women’s Hospital, and co-chairs the COVID-19 Drug Treatment Panel of the National Clinical Evidence Taskforce.
“Most of the recommendations in the guidelines have been based on randomised controlled trials that were conducted earlier on in the pandemic, during the time of the Delta variant, and many of the trials did not include vaccinated patients,” she said.
The COVID-19 landscape has changed
The current COVID-19 epidemiological and vaccination situation in Australia is now very different, Associate Professor Barber said.
“Omicron variants have emerged, and vaccination rates as well as prior infection rates are very high, so the risk of a patient with COVID-19 progressing to severe disease, or requiring hospitalisation, is very much reduced,” she said.
“For example, in a recent large clinical trial conducted in the United Kingdom which included over 20 000 patients (aged over 50 years, or over 18 years with comorbidities), only 1% of patients required hospitalisation. And some other recent observational studies have reported even lower hospitalisation rates.
“So, in this context, even if a treatment does reduce the chance of a patient requiring hospitalisation, if the risk of hospitalisation is very low to begin with, then the absolute benefit of giving a certain treatment may be quite low.”
The importance of living guidelines
Without the development of living guidelines, it would be very difficult for clinicians to keep up with best practice, she said.
“Since the onset of the COVID-19 pandemic, there has been an unprecedented number of clinical trials evaluating new treatments,” Associate Professor Barber said.
“So, in this context, the development of living guidelines has been really important, as otherwise, traditional guidelines would be out of date by the time they are published.
“Living guidelines enable new data to be reviewed very quickly and incorporated into treatment recommendations.
“This means that recommendations are kept up to date, and the guidelines are able to support clinicians with providing their patients with the best possible care.”
COVID-19 patients needing hospitalisation
Treatment considerations are quite different for patients who already have severe COVID-19 compared with people with mild disease.
However, here are some evidence gaps in producing treatment guidelines for people who are severely unwell from the disease, Associate Professor Barber said.
“For these patients, in addition to the intravenous antiviral remdesivir (except for patients who are mechanically ventilated), the guidelines also recommend administering a corticosteroid, generally dexamethasone,” she said.
“There are also a number of other immunomodulatory agents that can be given, such as tocilizumab and baricitinib.
“However, there are a number of important evidence gaps.”
Associate Professor Barber said more studies are needed to evaluate different treatment regimens in these patients.
“For example, we don’t really know which of these agents is most effective, or whether we should be giving them in combination. And again, the outcomes from COVID-19, even in hospitalised patients, are not as poor as they were during the time of the Delta variant.”
Patients who are immunosuppressed
The medical community must also consider the needs of people who are immunosuppressed, Associate Professor Barber said.
“COVID-19 presents very differently in these patients, for example, patients can have very prolonged viraemia,” Associate Professor Barber said.
“So these patients may be given combination antiviral therapy, or a prolonged course of an antiviral, but further studies are needed to enable us to develop clear guidelines for this important patient group.”
Read the Perspective in The Medical Journal of Australia.
The Medical Journal of Australia has published several guideline summaries on COVID-19:
- https://www.mja.com.au/journal/2022/217/9/national-covid-19-clinical-evidence-taskforce-pregnancy-and-perinatal-guidelines
- https://www.mja.com.au/journal/2022/217/7/care-adults-covid-19-living-guidelines-national-covid-19-clinical-evidence
- https://www.mja.com.au/journal/2022/216/4/care-older-people-and-people-requiring-palliative-care-covid-19-guidance
- https://www.mja.com.au/journal/2022/216/5/clinical-care-children-and-adolescents-covid-19-recommendations-national-covid
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