Health department’s nudge letter study ignored ‘ethical rights’ of GPs: Lancet letter
A Lancet journal has published a letter by three prominent Australian GPs saying a Federal Government-funded study that involved sending GPs ‘nudge letters’ failed to respect doctors’ rights.
The study, published in The Lancet Primary Care in April, showed that GPs who received letters saying they were in the 90th percentile for ordering particular tests or test batteries reduced orders for those tests by 36% in the next six months.
The RACGP, ACRRM and the AMA provided feedback on the style of the letters, which were signed by then chief medical officer Professor Paul Kelly.
The 5964 GPs who received letters, as well as 625 GPs in the 90th percentile who were used as controls and did not receive letters, were not told they were part of a study.
The Bond University Human Research Ethics Committee decided that the doctors’ consent was unnecessary because the intervention was low risk, obtaining consent was impracticable and adequate privacy protections were in place.
But Canberra GP Professor Louise Stone, Sydney GP and lecturer Dr Michael Tam and Adelaide GP Dr Oliver Frank have penned a letter, published in the same journal last month, raising concerns about the consent waiver.
“The researchers acknowledge that the design did not consider the pre-test probability of specific tests in diverse populations or the possible adverse impacts on patient outcomes … GPs were not informed that they were included in a trial and were not given the opportunity to withhold their consent.
“The researchers argue that gaining specific consent would make the study unfeasible and that government endorsement made consent unnecessary. We disagree.
“Governments may intervene in clinical practice without specific consent, but researchers should not.”
They said it would have been possible to use opt-out consent to “enable GPs to exercise their right to withhold their data from the study”.
“Respect for autonomy, dignity, and fundamental humanity should be non-negotiable in research.
“We ask the team to consider clinicians’ ethical rights in future studies.”
A response from the study researchers was published in the journal on the same day.
The team led by Monash University researcher Professor Denise O’Connor, which included prominent GP Professor Paul Glasziou, said obtaining consent had been impractical “given the nature and scale of the dataset”.
“We thank Louise Stone and colleagues for their correspondence, which provides us an opportunity to again clarify several points,” they said.
They stressed the nudge letters were variations of the type of audit and feedback letters the Department of Health, Disability and Ageing sent anyway.
“The study evaluated feedback variations that carried no more than minimal risk of discomfort or inconvenience to participants compared with usual feedback … The feedback acknowledged that the clinical reasons for requests were not captured by the data and multiple factors could influence request rates.
“Participants were invited to reflect on the information and make their own judgements regarding their future clinical practice.”
Read more:
- ‘Nudge letters’ reduced GP pathology requests by 42,000 a year: Lancet study
- Professor Paul Glasziou defends GP nudge letter experiment
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