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
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.186 | 0.140 |
| Meta-epidemiology (narrow) | 0.004 | 0.003 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.005 | 0.004 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.005 | 0.006 |
| Open science | 0.005 | 0.008 |
| Research integrity | 0.006 | 0.008 |
| Insufficient payload (model declined to judge) | 0.060 | 0.017 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".