PMID- 34764170
OWN - NLM
STAT- MEDLINE
DCOM- 20211206
LR  - 20211214
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 11
DP  - 2021 Nov 11
TI  - Expert consensus on a standardised definition and severity classification for 
      adverse events associated with spinal and peripheral joint manipulation and 
      mobilisation: protocol for an international e-Delphi study.
PG  - e050219
LID - 10.1136/bmjopen-2021-050219 [doi]
LID - e050219
AB  - INTRODUCTION: Spinal and peripheral joint manipulation (SMT) and mobilisation 
      (MOB) are widely used and recommended in the best practice guidelines for 
      managing musculoskeletal conditions. Although adverse events (AEs) have been 
      reported following these interventions, a clear definition and classification 
      system for AEs remains unsettled. With many professionals using SMT and MOB, 
      establishing consensus on a definition and classification system is needed to 
      assist with the assimilation of AEs data across professions and to inform 
      research priorities to optimise safety in clinical practice. METHODS AND 
      ANALYSIS: This international multidisciplinary electronic Delphi study protocol 
      is informed by a scoping review and in accordance with the 'Guidance on 
      Conduction and Reporting Delphi Studies'. With oversight from an expert steering 
      committee, the study comprises three rounds using online questionnaires. Experts 
      in manual therapy and patient safety meeting strict eligibility criteria from the 
      following fields will be invited to participate: clinical, medical and legal 
      practice, health records, regulatory bodies, researchers and patients. Round 1 
      will include open-ended questions on participants' working definition and/or 
      understanding of AEs following SMT and MOB and their severity classification. In 
      round 2, participants will rate their level of agreement with statements 
      generated from round 1 and our scoping review. In round 3, participants will 
      rerate their agreement with statements achieving consensus in round 2. Statements 
      reaching consensus must meet the a priori criteria, as determined by descriptive 
      analysis. Inferential statistics will be used to evaluate agreement between 
      participants and stability of responses between rounds. Statements achieving 
      consensus in round 3 will provide an expert-derived definition and classification 
      system for AEs following SMT and MOB. ETHICS AND DISSEMINATION: This study was 
      approved by the Canadian Memorial Chiropractic College Research Ethics Board and 
      deemed exempt by Parker University's Institutional Review Board. Results will be 
      disseminated through scientific, professional and educational reports, 
      publications and presentations.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Funabashi, Martha
AU  - Funabashi M
AUID- ORCID: 0000-0002-0292-8668
AD  - Division of Research and Innovation, Canadian Memorial Chiropractic College, 
      Toronto, Ontario, Canada mfunabashi@cmcc.ca.
AD  - Department of Chiropractic, University of Quebec in Trois Rivieres, 
      Trois-Rivieres, Quebec, Canada.
FAU - Pohlman, Katherine A
AU  - Pohlman KA
AUID- ORCID: 0000-0002-1536-112X
AD  - Research Center, Parker University, Dallas, Texas, USA.
FAU - Gorrell, Lindsay M
AU  - Gorrell LM
AUID- ORCID: 0000-0002-1937-741X
AD  - Integrative Spinal Research Group, Department of Chiropractic Medicine, Balgrist 
      University Hospital, Zurich, ZH, Switzerland.
FAU - Salsbury, Stacie A
AU  - Salsbury SA
AUID- ORCID: 0000-0002-9668-2426
AD  - Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 
      Davenport, Iowa, USA.
FAU - Bergna, Andrea
AU  - Bergna A
AUID- ORCID: 0000-0002-2526-9642
AD  - Research Department, SOMA Istituto Osteopatia Milano, Milan, Italy.
FAU - Heneghan, Nicola R
AU  - Heneghan NR
AUID- ORCID: 0000-0001-7599-3674
AD  - School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, 
      Birmingham, UK.
LA  - eng
PT  - Journal Article
DEP - 20211111
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Canada
MH  - *Chiropractic
MH  - Consensus
MH  - Delphi Technique
MH  - Humans
MH  - *Musculoskeletal Diseases
PMC - PMC8587360
OTO - NOTNLM
OT  - adverse events
OT  - complementary medicine
OT  - health & safety
COIS- Competing interests: None declared.
EDAT- 2021/11/13 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/11/11
CRDT- 2021/11/12 06:00
PHST- 2021/11/12 06:00 [entrez]
PHST- 2021/11/13 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/11/11 00:00 [pmc-release]
AID - bmjopen-2021-050219 [pii]
AID - 10.1136/bmjopen-2021-050219 [doi]
PST - epublish
SO  - BMJ Open. 2021 Nov 11;11(11):e050219. doi: 10.1136/bmjopen-2021-050219.