The Scoliosis Research Society adult spinal deformity standard outcome set

Abstract

Purpose: Symptomatic adult spinal deformity (ASD) with an extremely variable presentation with pain, with and without neurogenic leg pain, and/or disturbed sagittal and coronal balance, causes a significant societal burden of disease. It is an important consequence of the aging adult population, generating a plethora of spine-related interventions with variable treatment efficacy and consistently high costs. Recent years have witnessed more than a threefold increase in the prevalence and treatment of ASD, and further increases over the coming decades are expected with the growing elderly population worldwide. The ability to monitor and assess clinical outcomes has not kept pace with these developments. This paper addresses the pressing need to provide a set of common outcome metrics for this growing group of patients with back pain and other disabilities due to an adult spinal deformity.

Methods: The standard outcome set was created by a panel with global representation, using a thorough modified Delphi procedure. The three-tiered outcome hierarchy (Porter) was used as a framework to capture full cycle of care. The standardized language of the International Classification of Functioning, Disability and Health (WHO-ICF) was used.

Results: Consensus was reached on a core set of 25 WHO-ICF outcome domains ('What to measure'); on the accompanying globally available clinician and patient reported measurement instruments and definitions ('How to measure'), and on the timing of the measurements ('When to measure'). The current work has brought to light domains not routinely reported in the spinal literature (such as pulmonary function, return to work, social participation), and domains for which no adequate instruments have yet been identified (such as how to clinically quantify in routine practice lumbar spinal stenosis, neurogenic claudication, radicular pain, and loss of lower extremity motor function).

Conclusion: A standard outcome set was developed for patients undergoing treatment for adult spinal deformity using globally available outcome metrics. The current framework can be considered a reference for further work, and may provide a starting point for routine methodical and systematic monitoring of outcomes. Post-COVID e-health may accelerate the routine capture of these types of data.

Keywords: Adult spinal deformity; Core outcome set; Delphi technique; Outcomes assessment; Patient-reported outcomes; Spine.

Fig. 1

Workflow of the modified Delphi process. Blue boxes refer to work of current paper. Green boxes refer to a previously published systematic review [20]. Grey boxes are described in methods section under “Delphi procedure”, but due to complexity and the required descriptions the relevant case-mix and risk factors are out of scope of this study

Fig. 2

Flow of results throughout the modified Delphi procedure for outcome domains and measurement instruments. The threshold for consensus was set at ≥ 75% agreement. Items with < 50% agreement and/or repeated lack of consensus were excluded. Items with 50–75% consensus were made available again for voting in the subsequent round, and additional information from the literature was provided to make an informed decision. Combi refers to a combination of PROMs, PROM patient-reported outcome measure, ICF International Classification of Functioning, Disability and Health (WHO-ICF)

Fig. 3

Factsheet with the outcome domains of ASD identified in this study, using the framework of the three-tiered outcome hierarchy as developed by Porter [4]