Defining a core outcome set for adolescent and young adult patients with a spinal deformity.

Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.

Scoliosis Research Society survey: brace management in adolescent idiopathic scoliosis.

PURPOSE: While the Scoliosis Research Society (SRS) has established criteria for brace initiation in adolescent idiopathic scoliosis (AIS), there are no recommendations concerning other management issues. As the BrAIST study reinforced the utility of bracing, the SRS Non-Operative Management Committee decided to evaluate the consensus or discord in AIS brace management. METHODS: 1200 SRS members were sent an online survey in 2017, which included 21 items concerning demographics, bracing indications, management, and monitoring. Free-text responses were analyzed and collated into common themes. Data were analyzed using Microsoft Excel 2013. RESULTS: Of 218 respondents; 207 regularly evaluate and manage patients with AIS, and 205 currently prescribe bracing. 99% of respondents use bracing for AIS and the majority (89%) use the published SRS criteria, or a modified version, to initiate bracing. 85% do not use brace monitoring and 66% use both %-Cobb correction and fit criteria to evaluate brace adequacy. In contrast, other aspects of brace management demonstrated a high degree of practice variability. This was seen with a radiographic assessment of maturity level, hours prescribed, timing and frequency of radiographic evaluation, the use of nighttime bracing only, and the method and timing of brace discontinuation. CONCLUSION: Although there is consensus in brace management amongst SRS members with respect to brace initiation and evaluation of adequacy, there is striking variability in how bracing for AIS is used. This variability may impact the overall efficacy of brace treatment and may be decreased with more robust guidelines from the SRS. LEVEL OF EVIDENCE: III.

A health economic evaluation of screening and treatment in patients with adolescent idiopathic scoliosis.

SUMMARY OF BACKGROUND DATA: Adolescent idiopathic scoliosis can progress and affect the health related quality of life of the patients. Research shows that screening is effective in early detection, which allows for bracing and reduced surgical rates, and may save costs, but is still controversial from a health economic perspective. STUDY DESIGN: Model based cost minimisation analysis using hospital's costs, administrative data, and market prices to estimate costs in screening, bracing and surgical treatment. Uncertainty was characterised by deterministic and probabilistic sensitivity analyses. Time horizon was 6 years from first screening at 11 years of age. OBJECTIVE: To compare estimated costs in screening and non-screening scenarios (reduced treatment rates of 90%, 80%, 70% of screening, and non-screening Norway 2012). METHODS: Data was based on screening and treatment costs in primary health care and in hospital care settings. Participants were 4000, 12-year old children screened in Norway, 115190 children screened in Hong Kong and 112 children treated for scoliosis in Norway in 2012. We assumed equivalent outcome of health related quality of life, and compared only relative costs in screening and non-screening settings. Incremental cost was defined as positive when a non-screening scenario was more expensive relative to screening. RESULTS: Screening per child was € 8.4 (95% CrI 6.6 to10.6), € 10350 (8690 to 12180) per patient braced, and € 45880 (39040 to 55400) per child operated. Incremental cost per child in non-screening scenario of 90% treatment rate was € 13.3 (1 to 27), increasing from € 1.3 (-8 to 11) to € 27.6 (14 to 44) as surgical rates relative to bracing increased from 40% to 80%. For the 80% treatment rate non-screening scenario, incremental cost was € 5.5 (-6 to 18) when screening all, and € 11.3 (2 to 22) when screening girls only. For the non-screening Norwegian scenario, incremental cost per child was € -0.1(-14 to 16). Bracing and surgery were the main cost drivers and contributed most to uncertainty. CONCLUSIONS: With the assumptions applied in the present study, screening is cost saving when performed in girls only, and when it leads to reduced treatment rates. Cost of surgery was dominating in non-screening whilst cost of bracing was dominating in screening. The economic gain of screening increases when it leads to higher rates of bracing and reduced surgical rates.

School screening and point prevalence of adolescent idiopathic scoliosis in 4000 Norwegian children aged 12 years.

BACKGROUND: School screening for adolescent idiopathic scoliosis (AIS) is discussed. The aim of the present study was to describe the point prevalence of AIS and to evaluate the effectiveness of school screening in 12-year- old children. METHODS: Community nurses and physical therapists in the Southern Health region of Norway including about 12000 school children aged 12 years were invited to participate. All participating community nurses and physical therapists fulfilled an educational course to improve their knowledge about AIS and learn the screening procedure including the Adam Forward Bending Test and measurement of gibbus using a scoliometer. RESULTS: Sub-regions including 4000 school children participated. The prevalence of idiopathic scoliosis defined as a positive Adam Forward Bending Test, gibbus > 7° and primary major curve on radiographs > 10°, was 0.55%. Five children (0.13%) had a major curve > 20°. Bracing was not indicated in any child; all children were post menarche; four had Risser sign of 4, and one with Risser 1 did not have curve progression > 5° at later follow-up. In one of these 5 children however, the major curve progressed to 45° within 7 months after screening and the girl was operated. CONCLUSION: The point prevalence of AIS in 12- year old children is in agreement or slightly lower than previous studies. The screening model employed demonstrates acceptable sensitivity and specificity and low referral rates. Screening at the age of 12 years only was not effective for detecting patients with indication for brace treatment.

Repeatability, reliability, and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis.

STUDY DESIGN: Cross-sectional study in patients with adolescent idiopathic scoliosis (AIS). OBJECTIVES: To evaluate the repeatability, reliability, internal consistency, and concurrent validity (CD) of an adapted Norwegian version of the Scoliosis Research Society 22 questionnaire (SRS-22) and the generic health-related quality of life instrument EuroQol (EQ-5D and EQ-VAS). SUMMARY OF BACKGROUND DATA: SRS-22 is widely used for evaluation of health-related quality of life in AIS. Its repeatability, which is essential for use in follow-up studies, and CD with EuroQol which can be used for cost-utility analysis, has not yet been assessed. METHODS: The forward-backward translation of the English version of the SRS-22 was performed according to guidelines for cross-cultural adaptation of outcome questionnaires. Fifty-seven patients of various ages with AIS and deformity severity filled out standardized questionnaires: SRS-22, EQ-5D, and EQ-VAS, each twice in a 2-week interval. The study was approved by the Regional Ethics Committee for Medical Research in Norway. RESULTS: There were no floor or ceiling effects on the score distributions. The study demonstrated moderate internal consistency and high reliability of SRS-22 questionnaire with Chronbach alpha and intraclass correlation coefficiency ranging from 0.76 to 0.93 for the 5 domains. Repeatability was excellent for all SRS-22 domains with repeatability coefficients <1. CD with EQ-5D was poor to moderate with Pearson's r ranging from 0.14 to 0.58. However, total scores of the 2 instruments showed satisfactory agreement. CONCLUSION: The SRS-22 outcome instrument has satisfactory repeatability, but CD with EQ-5D suggests that the disease-specific and the generic questionnaire measure different constructs.