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Minimal Clinically Important Difference (MCID) and Long-Term Prospective Validation of the AO Spine PROST (Patient
Said Sadiqi1, Charlotte Dandurand2, Richard J Bransford3
1Department of Orthopaedics, St. Antonius Hospital, Utrecht, The Netherlands.
Abstract:
Study designProspective observational multicenter cohort study.ObjectivesTo determine Minimal Clinically Important Difference (MCID) of AO Spine PROST (Patient Reported Outcome Spine Trauma) and conducting a long-term prospective validation.MethodsData were collected from a prospective observational international multicenter cohort study. Adults (18-65) with acute thoracolumbar (TL) burst fractures without neurologic deficits were enrolled, and followed for up to 2 years. Patients completed the AO Spine PROST, Oswestry Disability Index (ODI), EQ-5D, and Pain NRS. Characteristics were analyzed using descriptive statistics, MCID for PROST with distribution-based approach using the standard deviation (SD) of change in scores. Floor and ceiling effects were also evaluated. Internal consistency (Cronbach's alpha, item-total correlation coefficient (ITCC) and pairwise Spearman correlation), construct validity (Pearson correlations (rs) with ODI, EQ-5D, Pain NRS), and responsiveness (effect sizes (ES) and standardized response mean (SRM)) were assessed.ResultsNinety-three patients were included. MCID for a moderate change (0.5*SD) in PROST score was 10.6. No floor or ceiling effects were observed. Internal consistency was high (Cronbach's α = 0.9-1.0 and acceptable ITCC). PROST scores strongly correlated with ODI (rs = -0.67 to -0.89; P < .001), but correlations with EQ-5D were weak (rs = -0.29 to 0.05; P > .005), except at 1-year follow-up. No consistent pattern was found with Pain NRS. Responsiveness was very good (ES = 3.2, SRM = 3.1; P < .001).ConclusionsThe AO Spine PROST identified an MCID of 10.6 as indicative of a moderate clinically meaningful change. The instrument also showed strong internal consistency, construct validity, and excellent responsiveness in long-term follow-up.
Insights
The AO Spine PROST tool has an MCID of 10.6 for moderate changes in thoracolumbar burst fractures. This patient-reported outcome measure demonstrates strong validity and responsiveness over two years.
Area of Science:
- Spine Surgery
- Orthopedics
- Clinical Outcomes Research
Background:
- Assessing patient-reported outcomes is crucial for evaluating treatment effectiveness in spinal trauma.
- The AO Spine PROST (Patient Reported Outcome Spine Trauma) is a tool designed for this purpose.
- Establishing its Minimal Clinically Important Difference (MCID) and long-term validation is essential.
Purpose of the Study:
- To determine the MCID for the AO Spine PROST in patients with thoracolumbar burst fractures.
- To conduct a long-term prospective validation of the AO Spine PROST.
- To evaluate the psychometric properties of the AO Spine PROST, including validity and responsiveness.
Main Methods:
- A prospective, observational, international multicenter cohort study.
- Enrolled 93 adults (18-65) with acute thoracolumbar burst fractures without neurological deficits.
- Followed patients for up to 2 years, collecting data on AO Spine PROST, ODI, EQ-5D, and Pain NRS; analyzed using distribution-based methods for MCID and psychometric assessments.
Main Results:
- The MCID for a moderate change in AO Spine PROST score was determined to be 10.6.
- The instrument demonstrated high internal consistency (Cronbach's α = 0.9-1.0) and strong construct validity with the Oswestry Disability Index (ODI).
- Responsiveness was excellent (Effect Size = 3.2, Standardized Response Mean = 3.1), with no observed floor or ceiling effects.
Conclusions:
- An MCID of 10.6 for the AO Spine PROST indicates a moderate, clinically meaningful improvement in patients with thoracolumbar burst fractures.
- The AO Spine PROST exhibits robust psychometric properties, including strong internal consistency, construct validity, and excellent responsiveness.
- The study confirms the AO Spine PROST's utility as a reliable measure for long-term follow-up in this patient population.
