Development of a core measurement set for research in degenerative cervical myelopathy: a study protocol (AO Spine RECODE-DCM CMS)

Abstract

IntroductionProgress in degenerative cervical myelopathy (DCM) is hindered by inconsistent measurement and reporting of outcomes. This can, for example, impede the aggregation of data and comparison of outcomes between studies. This limitation can be reversed by developing a core measurement set (CMS) for use in DCM research. Previously, the AO Spine Research Objectives and Common Data Elements for DCM (AO Spine RECODE-DCM) defined ‘what’ should be measured in DCM: specifically, the core data elements and core outcome set of the disease. The next step of this initiative is to determine ‘how’ to measure these features. The current protocol outlines the steps necessary for the development of a CMS for DCM research and audit.Methods and analysisThe CMS will be developed in accordance with the guidance developed by the Core Outcome Measures in Effectiveness Trials (COMET) and the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The process will involve five phases: (1) agreement on the measurement constructs and approaches to their evaluation; (2) the formation of a long list of potential measurement instruments, by identifying existing instruments and assessing their psychometric properties; (3) the aggregation of evidence concerning ‘when’ measurements should be taken; (4) consensus about which instruments to include in the CMS; and (5) implementation.Ethics and disseminationEthical approval was obtained from the University of Cambridge. Dissemination strategies to promote awareness and adoption of the CMS include peer-reviewed scientific publications; conference presentations; podcasts; the identification of AO Spine RECODE-DCM ambassadors; and engagement with relevant journals, funders, and the DCM community.Impact of this workThe proposed project will enable standardised and comprehensive measurement in DCM clinical trials. The CMS will be established using a robust, global, and multi-stakeholder consensus process, with broad representation of healthcare professionals and individuals living with the disease. It will focus on measurement instruments currently in use. This ensures that the CMS will be immediately usable and suited for widespread adoption. The development of better outcome instruments in DCM remains a top 10 research priority and this work will hence facilitate knowledge generation for this important disease.

Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM)

“…Measurement rigour is universally important and, in DCM, particularly relevant as the development of new instruments is a top 10 research priority. This rank reinforces the decision of the steering committee to make the initial CMS recommendations based existing on tools, rather than on tools under development 26. This decision was taken recognising that the success of a CMS requires widespread adoption, and that the adoption of clinical recommendations can be challenging without stakeholder awareness, familiarity and/or confidence 43–46.…”

“…This rank reinforces the decision of the steering committee to make the initial CMS recommendations based existing on tools, rather than on tools under development. 26 This decision was taken recognising that the success of a CMS requires widespread adoption, and that the adoption of clinical recommendations can be challenging without stakeholder awareness, familiarity and/or confidence. [43][44][45][46] We hypothesised that asking the global field to align with new innovations would be more challenging, and premature, at this stage.…”

“…In light of these inconsistencies, AO Spine launched RECODE-DCM (www.aospine.org/recode) with the aim of creating a 'research toolkit’ that helps to accelerate knowledge discovery and improve outcomes in DCM. One of the objectives of the RECODE-DCM initiative was to develop a CMS 3 6 26. This systematic review consists of an initial step towards building this CMS by identifying tools that have been used in DCM research and examining their quality, in accordance with the COSMIN standards 23–25…”

“…Data were rated, aggregated and assessed for methodology bias using the COSMIN manual for systematic reviews of patient-reported outcome measures (PROMs) 23–25. This work builds on the protocol for the AO Spine RECODE-DCM initiative3 6 26 and complements two earlier reviews of outcome measures in DCM 2 21…”