PMID- 38481318 OWN - NLM STAT- MEDLINE DCOM- 20240315 LR - 20240328 IS - 2045-709X (Electronic) IS - 2045-709X (Linking) VI - 32 IP - 1 DP - 2024 Mar 13 TI - Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study. PG - 9 LID - 10.1186/s12998-024-00529-0 [doi] LID - 9 AB - BACKGROUND: Manual therapies are commonly used by healthcare professionals when caring for children. However, few prospective studies have evaluated their adverse events (AEs). 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. Preliminary data on AEs frequency are also reported. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov., NCT05409859, Registered on June 3 2022. https://clinicaltrials.gov/study/NCT05409859 . CI - (c) 2024. The Author(s). FAU - Dolbec, Anne AU - Dolbec A AD - Departement d'anatomie, Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. AD - Groupe de recherche sur les affections neuromusculosquelettiques (GRAN), Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. FAU - Doucet, Chantale AU - Doucet C AD - Departement de chiropratique, Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. FAU - Pohlman, Katherine A AU - Pohlman KA AD - Research Center, Parker University, 2540 Walnut Hill Lane, 75229, Dallas, TX, USA. FAU - Sobczak, Stephane AU - Sobczak S AD - Departement d'anatomie, Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. AD - Groupe de recherche sur les affections neuromusculosquelettiques (GRAN), Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. AD - Chaire de recherche en anatomie fonctionnelle, Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. FAU - Page, Isabelle AU - Page I AUID- ORCID: 0000-0002-7175-0402 AD - Departement de chiropratique, Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. Isabelle.Page@uqtr.ca. AD - Centre Interdisciplinaire de recherche en readaptation et integration sociale (Cirris), Centre Integre Universitaire de Sante et de Services Sociaux de la Capitale-Nationale (CIUSS-CN), 525 Boul. Wilfrid-Hamel, G1M 2S8, Quebec, Quebec, Canada. Isabelle.Page@uqtr.ca. AD - Groupe de recherche sur les affections neuromusculosquelettiques (GRAN), Universite du Quebec a Trois-Rivieres, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivieres, Quebec, Canada. Isabelle.Page@uqtr.ca. LA - eng SI - ClinicalTrials.gov/NCT05409859 GR - Fondation Chiropratique du Quebec/Fondation Chiropratique du Quebec/ GR - 288491/Fonds de Recherche du Quebec - Sante/ GR - Mitacs/Mitacs/ PT - Clinical Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20240313 PL - England TA - Chiropr Man Therap JT - Chiropractic & manual therapies JID - 101551481 SB - IM MH - Child, Preschool MH - Humans MH - *Chiropractic MH - Feasibility Studies MH - *Musculoskeletal Manipulations/adverse effects MH - Prospective Studies MH - Research Design PMC - PMC10938841 OTO - NOTNLM OT - Manual therapies OT - Pediatrics OT - Safety OT - Side effects OT - Spinal manipulations OT - Spinal mobilizations COIS- The authors declare that they have no competing interests. EDAT- 2024/03/14 06:46 MHDA- 2024/03/15 06:43 PMCR- 2024/03/13 CRDT- 2024/03/14 03:33 PHST- 2023/10/24 00:00 [received] PHST- 2024/01/23 00:00 [accepted] PHST- 2024/03/15 06:43 [medline] PHST- 2024/03/14 06:46 [pubmed] PHST- 2024/03/14 03:33 [entrez] PHST- 2024/03/13 00:00 [pmc-release] AID - 10.1186/s12998-024-00529-0 [pii] AID - 529 [pii] AID - 10.1186/s12998-024-00529-0 [doi] PST - epublish SO - Chiropr Man Therap. 2024 Mar 13;32(1):9. doi: 10.1186/s12998-024-00529-0.