This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger and to report preliminary data on AEs frequency.
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child’s participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
The authors concluded that their results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians’ recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
It is hardly surprising that such a study is ‘feasible’. I could have told the authors that and saved them the trouble of doing the study. What is surprising, in my view, that chiropractors, after ~120 years of existence of the profession, ask whether it is feasible.
I suggest to do the definitive study on a much larger sample, extend the observation period, and recruit a representative rather than self-selected sample of chiros … or – much better – forget about the study and establich a functioning post-marketing surveillance system.
4 Responses to Adverse events associated with chiropractic care in pre-school pediatric population
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I am surprised that an ethics committee appears to have approved this study, in view of the lack of evidence of any benefit of chiropractic to infants.
So when there is no AE registration you are against when they suggest something on these lines you are also against… when was the last time you were in favour of something to do with chiropractic?
did I not state that they should rather establish a post-marketing surveillance system?
“when was the last time you were in favour of something to do with chiropractic?”
easy answer: when there was sound evidence that chiropractic does more good than harm.
Prof Ernst (proper doctor as you have a PhD). You have double standards. When asked to provide evidence of the scientific validity of Physiotherapy, “Dr” (not a proper doctor as she does not have a PhD) Sue Ireaci has chosen not to reply with any evidence. You have done the same. So, one must ask, “Does it do any good, and where is the evidence?” Please be consistent with your demands.
How are you going to react when U.S. trained physical therapists with a “Doctor of Physical Therapy” degree come to the U.K. and be expected to be addressed as “Dr. Name”. They will claim to have a “doctorate”, but in your eyes, do they and should they be addressed as “Dr.”