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

Abstract

ObjectivesTo evaluate the measurement properties of outcome measures currently used in the assessment of degenerative cervical myelopathy (DCM) for clinical research.DesignSystematic reviewData sourcesMEDLINE and EMBASE were searched through 4 August 2020.Eligibility criteriaPrimary clinical research published in English and whose primary purpose was to evaluate the measurement properties or clinically important differences of instruments used in DCM.Data extraction and synthesisPsychometric properties and clinically important differences were both extracted from each study, assessed for risk of bias and presented in accordance with the Consensus-based Standards for the selection of health Measurement Instruments criteria.ResultsTwenty-nine outcome instruments were identified from 52 studies published between 1999 and 2020. They measured neuromuscular function (16 instruments), life impact (five instruments), pain (five instruments) and radiological scoring (five instruments). No instrument had evaluations for all 10 measurement properties and <50% had assessments for all three domains (ie, reliability, validity and responsiveness). There was a paucity of high-quality evidence. Notably, there were no studies that reported on structural validity and no high-quality evidence that discussed content validity. In this context, we identified nine instruments that are interpretable by clinicians: the arm and neck pain scores; the 12-item and 36-item short form health surveys; the Japanese Orthopaedic Association (JOA) score, modified JOA and JOA Cervical Myelopathy Evaluation Questionnaire; the neck disability index; and the visual analogue scale for pain. These include six scores with barriers to application and one score with insufficient criterion and construct validity.ConclusionsThis review aggregates studies evaluating outcome measures used to assess patients with DCM. Overall, there is a need for a set of agreed tools to measure outcomes in DCM. These findings will be used to inform the development of a core measurement set as part of AO Spine RECODE-DCM.

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

“…Phases 2.1 and 2.2 have been completed. Phase 2.1 has been published separately 45 ; thus, only a summary is provided here. Phase 2.2 and its results are included here.…”

“…To evaluate the methodological quality of the identified instruments, the same COSMIN process as in phase 2.1 45 will be used. Recognising that evaluating an uncapped number of instruments with the COSMIN manual can quickly become unrealistic, we will limit the number of instruments for COSMIN review to two per ‘gap’ outcome.…”

Improving Assessment of Disease Severity and Strategies for Monitoring Progression in Degenerative Cervical Myelopathy [AO Spine RECODE-DCM Research Priority Number 4]

“…95 , 96 A recent systematic review determined the psychometric properties of the PROMs and ClinROMs available in DCM using the COSMIN guidelines. 97 The quality of 28 tools assessing 7395 global patients was evaluated using modified GRADE criteria. Unfortunately, none of the 28 outcome measures were recommended for use in a clinical setting.…”

“…Instead, the majority of tools (24/28) were categorized as “potential” candidates that required further research. 97 As illustrated by Figure 1 , these ratings were, in part, due to the absence of studies investigating structural validity (a key aspect of construct validity) as well as the methodological limitations of the studies that assessed other psychometric properties. While an absence of high-quality evidence is not an indication that a tool is inadequate, these knowledge gaps are concerning and must be addressed.…”

“…Furthermore, given the increasing number of outcome measures available and the lack of uniformity within the field, new and improved tools will likely be required. 10 , 42 , 97 The robust development of such tools will take time.…”