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

Abstract

IntroductionSpinal 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 analysisThis 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 disseminationThis 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.

Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review

“… 47 Specifically, the authors report that conflicting opinions regarding facets of adverse event definition and classification such as: symptom severity and duration, relatedness to the intervention (eg, time to onset and treatment provided), action taken to treat the symptoms and expectedness, which profession delivered the intervention and geographical location (with possible medico-legal constraints and/or different expectations of reporting/not reporting), are all factors to reflect on when considering adverse events associated with joint manipulation and mobilisation. In an attempt to address the lack of standardised definitions and classification systems across professions that deliver spinal manipulation, the same authors have conducted an international Delphi study (manuscript in preparation; protocol paper 41 ) to determine, by expert consensus, a standardised definition and severity classification for adverse events associated with spinal and peripheral joint manipulation and mobilisation. The development and use of such guidelines would constitute an important step toward uniform reporting of adverse events associated with spinal manipulation across all stakeholder professions and geographical locations.…”

“… 26 52 Additionally, when present, the reporting of onset and duration of adverse events was inconsistent, again highlighting that there is an urgent need for the development of a standardised definition and classification system for the reporting of adverse events. 41 Furthermore, the responsibility for improved reporting of adverse events falls not only to authors but also to custodians of clinical trial registries and journal editors to ensure that there are provisions in study protocols for the adequate capture of adverse events and also that these events are adequately reported. that is, using the most recent CONSORT Harms extension guidelines, 24 alongside efficacy/effectiveness data.…”

“…Further complicating this issue is the vast heterogeneity of terms (ie, ‘adverse effect’, ‘side effect’, ‘harm’, etc) used to describe adverse events. This is disappointing given that there have been many calls in the literature for the improvement of adverse events reporting in RCTs, and for the development and use of standardised definitions and classification systems 24 26 32 41–46…”

Definition and classification for adverse events following spinal and peripheral joint manipulation and mobilization: A scoping review

“…(3) study selection; (4) charting the data; and (5) collating, summarizing and reporting the results [28,29]. The optional consultation exercise (step 6) was not included within the scope of this specific manuscript as the results will be used to inform an e-Delphi study [30].…”

“…Based on these findings, an e-Delphi study will be conducted to establish a standardized adverse event definition and classification system that can be prospectively used across multiple professions [30]. This has the potential to greatly advance patient safety as it would provide a standardized framework for data to be collected and synthesized in an uniform manner.…”