Standardization of Adverse Event Terminology and Reporting in Orthopaedic Physical Therapy: Application to the Cervical Spine
Bibliographic record
Abstract
SYNOPSIS: Orthopaedic physical therapy is considered safe, based on a lack of reported harms. Most of the research until now has focused on benefits. Consideration of benefits and harm involves informed consent, clinical decision making, and cost-benefit analyses. Benefits and harms are treatment and dosage specific. There is currently an insufficient number of dosage trials in orthopaedic physical therapy to identify optimal dosage for common interventions, including exercise and manual therapy. Published cases of severe adverse events following chiropractic manipulation illustrate the need for physical therapy to have high-quality data documenting the safety of orthopaedic physical therapy, including cervical manipulation. A recent systematic review identified poor reporting standards of harms within clinical research in this area. Lack of standardization of terminology has contributed to this problem. Pharmacovigilence provides a framework for terms that orthopaedic physical therapy can adapt and thereafter adopt into clinical practice and research. Adverse events are unexpected events that occur following an intervention without evidence of causality. Where temporality of an event is highly suggestive of causality, the term "adverse reaction" may be more appropriate. Future studies in orthopaedic physical therapy should adopt the CONSORT statement extension on the reporting of harms, published in 2004, to ensure better reporting. Consistent reporting of harms in both research and clinical practice requires professional consensus on terminology pertaining to harms, as well as defining what constitutes an adverse event or an adverse reaction. Widespread consultation and consensus should support optimal definitions and processes and facilitate their implementation into practice. This paper is focused on theoretical considerations and evidence in terms of harm reporting within physical therapy using cervical manual therapy as an example.
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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 | 0.349 | 0.589 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.005 | 0.007 |
| Bibliometrics | 0.016 | 0.017 |
| Science and technology studies | 0.003 | 0.012 |
| Scholarly communication | 0.009 | 0.009 |
| Open science | 0.007 | 0.010 |
| Research integrity | 0.010 | 0.019 |
| Insufficient payload (model declined to judge) | 0.005 | 0.005 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".