PEDIATRICS Vol. 119 No. 6 June 2007, pp. 1266-1267 (doi:10.1542/peds.2007-0900)
LETTER TO THE EDITOR |
Adverse Events in the Manipulation of Pediatric Patients: Flaws in a Systematic Review: In Reply
Sunita Vohra, MD, MSc, FRCPCBradley C. Johnston, ND
Complementary and Alternative Research and Education Program
Department of Pediatrics
University of Alberta
Edmonton, Alberta, Canada T6G 2E1
Kim Humphreys, DC, PhD
Graduate Education and Research
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada M2H 3J1
We appreciate the interest in our work. To date, we have received correspondence from the chiropractic community, suggesting that we overstated the data, and the medical community, suggesting that we understated them. The advantage of a systematic review is that it allows for a transparent approach to the subject area to minimize bias. We appreciate the careful review our work has received. In particular, 2 errors were identified with regards to material that was correctly cited in tables but incorrectly cited in text (eg, right text in wrong location). We have notified the journal editors so that these errors may be rectified. We would like to address some of the other concerns raised.
The objectives and methods of this review seem to have been misinterpreted by some. The purpose of our systematic review was to assess the safety of pediatric spinal manipulation, not its efficacy or the safety of other interventions. These topics were appropriately omitted from our article. In addition, our review was not limited to cervical manipulation, as Rosner seemed to indicate. Because we could not locate validated adverse-event categories, we chose categories/definitions that are consistent with those used by the National Institutes of Health.1 By definition, minor events had to be self-resolving and not require additional medical care. Each of the minor adverse events reported in our article met the a priori definition.2,3 We did not think it was reasonable to omit the delayed diagnosis/treatment that was revealed through our systematic review, and we, therefore, applied the same categories to classify the resulting harms.
We actively collaborate with a variety of complementary and alternative medicine institutions, including a national chiropractic college. Our recent research has identified a need for more pediatric training for chiropractors, an opinion voiced by chiropractors themselves. In fact, 97% of 180 responding chiropractors recommended increased pediatric training.4 Our systematic review corroborates that children with serious underlying disease may suffer delayed diagnosis or treatment. It seems only prudent to encourage parents to discuss their child's health and health care practices with their child's physician.
Because of the paucity of data, risk estimates or causal inferences were not possible. Serious adverse events are often rare and require population-based exposure before they can be detected. Previous experience has shown that multiple spontaneous reports of a given adverse event are unlikely to be a result of chance alone.5,6 It is not possible to identify the incidence rate of adverse events without better-quality data. Lack of reported adverse events about pediatric spinal manipulation should not be interpreted as a confirmation of safety, nor can it be deemed prima facie evidence of underreporting. Our systematic review clearly illustrates the gap in knowledge on this topic. We urge multidisciplinary collaboration to prospectively quantify risks associated with pediatric spinal manipulation. A multidisciplinary approach by all those who provide spinal manipulation (eg, chiropractors, physicians, physical therapists) should be encouraged to minimize bias and maximize "buy-in" from the disciplines involved. Health care providers cannot seek informed consent, nor can parents provide it, if the risks are unknown. Our intent was to highlight the need for additional research by contrasting it with the scant available data on this topic. If we are to learn from conventional medicine, that lesson should be that patient safety is not assured by good intentions alone.
REFERENCES
- National Institutes of Health. General characteristics of the CTCAE grading (severity) scale. Available at: https://webapps.ctep.nci.nih.gov/webobjs/ctc/webhelp/Grading_General_Characteristics.htm. Accessed March 6, 2007
- Sawyer CE, Evans RL, Boline PD, Branson R, Spicer A. A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children. J Manipulative Physiol Ther. 1999;22 :292 –298[CrossRef][Web of Science][Medline]
- Klougart N, Leboeuf-Yde C, Rasmussen LR. Safety in chiropractic practice, part II: treatment to the upper neck and the rate of cerebrovascular incidents. J Manipulative Physiol Ther. 1996;19 :563 –569[Medline]
- Adams D, Amernic H, Humphreys K, et al. A survey of complementary and alternative medicine practitioners’ knowledge, attitudes, and behavior regarding children in their practice. Presented at: Pediatric Academic Society Meeting; April 29 to May 2, 2006; San Francisco, CA
- Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms.
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[Abstract/Free Full Text] - Begaud B, Moride Y, Tubert-Bitter P, et al. False-positives in spontaneous reporting: should we worry about them. Br J Clin Pharmacol. 1994;38 :401 –404[Web of Science][Medline]
PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics
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