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Utilization of a Wide Array of Nonvalidated Outcome Scales in Pediatric Orthopaedic Publications: Can't We All
Walter H Truong1, Meghan J Price2, Kunal N Agarwal2
1Gillette Children's Specialty Healthcare, University of Minnesota, Twin Cities, MN.
Insights
Pediatric orthopaedic studies increasingly use patient-reported outcome measures (PROMs) and surgeon-reported outcome measures (SROMs), but many are not validated for children or applied appropriately. This highlights a need for standardized, validated outcome measures in pediatric orthopaedics.
Area of Science:
- Pediatric Orthopaedics
- Clinical Research Methodology
- Outcome Measurement
Background:
- Standardized, validated outcome measures, including patient-reported outcome measures (PROMs) and surgeon-reported outcome measures (SROMs), are crucial for evaluating clinical changes.
- The use of appropriate outcome measures ensures the reliability and generalizability of research findings in pediatric populations.
Purpose of the Study:
- To analyze the spectrum of outcome measures utilized in pediatric orthopaedic publications over a decade (2005-2014).
- To assess the proportion of these outcome measures that are age-appropriate, validated for pediatric use, and correctly applied to specific conditions and populations.
Main Methods:
- Systematic review of four major pediatric orthopaedic journals from January 2005 to December 2014.
- Exclusion of economic evaluations, letters, editorials, reviews, and guidelines.
- Extraction and assessment of PROMs and SROMs for validity, age-appropriateness, and disease-specificity; trend analysis of utilization.
Main Results:
- Of 2251 included articles, 11.5% used PROMs and 14.5% used SROMs.
- Only 38.3% of PROMs and 18.7% of SROMs were appropriately applied.
- While PROM use significantly increased, there was no corresponding rise in the use of pediatric-validated PROMs.
Conclusions:
- A wide variety of outcome scales are employed in pediatric orthopaedics, with many lacking pediatric validation.
- There is a critical need for improved uniformity and the adoption of validated, age- and disease-appropriate outcome scales.
- This will enhance multicenter research collaboration, data quality, and the generation of evidence-based treatment strategies.
Purpose:
Clinical changes are best evaluated with standardized, validated outcomes, including both patient-reported outcome measures and surgeon-reported outcome measures (PROMs and SROMs). The purpose of this study was to describe the spectrum of outcome measures used in pediatric orthopaedic publications over the past 10 years and to determine the proportion that are in fact age-appropriate, validated, and appropriately applied in terms of condition and population.
Methods:
The Journal of Bone and Joint Surgery, The Bone and Joint Journal, Journal of Pediatric Orthopaedics A and B, and Journal of Children's Orthopaedics were systematically searched for studies including children aged 18 and below, over a 10-year period from January 2005 to December 2014. Economic evaluations, letters, editorials, review articles, and clinical guidelines were excluded. SROMs and PROMs used were extracted, as were details on subject age and condition for which they were used. Each outcome scale was assessed for validity, and the proportion of scales used appropriately was calculated. Cochrane-Armitage test of trend was used to determine changes in PROM and SROM utilization over the study period.
Results:
A total of 4614 articles were identified, of which 2251 met inclusion and exclusion criteria. In total, 259 (11.5%) of studies used a PROM, whereas 326 (14.5%) used a SROM. A total of 230 different outcome scales were identified; 115 were patient reported and 115 were surgeon reported. However, only 18.7% of SROMs and 38.3% of PROMs were applied to an age and disease-appropriate demographic. Overall, there was a significant increase in the overall utilization of PROMs during the study period (P=0.004), but no corresponding increase in pediatric-validated PROMs (P=0.164). SROM utilization did not significantly change over the study period (P=0.337).
Conclusions:
Within the field of pediatric orthopaedics, an expansive variety of outcome scales are used, many of which have not been validated in children. Improved uniformity in reporting of outcomes and use of disease and age-validated outcomes scales is essential to improve multicenter research collaboration and data quality to generate appropriate evidence-based conclusions and treatment strategies in pediatric orthopaedics.
Level Of Evidence:
Level IV-systematic review.