Assessing the Quality of Life in Adults With Spinal Deformity

Assessing the Quality of Life in Adults With Spinal Deformity: a Retrospective Comparison Between Two Questionnaires

Spinal deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools for this condition have been developed to investigate the extent of this impact, such as the SRS-22 questionnaire and ISYQOL questionnaire.

The latter was initially used for underage patients, but given that some of them continue their therapy and the monitoring beyond the age of 18, we have continued its use in these subjects as well. Given the clinical usefulness and given the lack of questionnaires developed in the Rasch environment for adults, we have extended the application of the ISYQOL questionnaire to the adult population. However, a comparison between the ISYQOL and SRS-22 in adults has not yet been made.

The objective of this study is to verify the validity of ISYQOL and to compare the properties of ISYQOL with those of the SRS-22 questionnaire in adults with spinal deformity.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Scoliosis
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20141
      • ISICO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring

Description

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosis of idiopathic or degenerative scoliosis with ≥30 ° Cobb curve

Exclusion Criteria:

• Previous spinal surgery
• Previous and relevant illnesses, surgery or trauma

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quality of life; Adult patients treated conservatively for idiopathic scoliosis or undergoing clinical monitoring who have completed both questionnaires at least once and simultaneously and who meet the following inclusion criteria: Age ≥ 18 years; Diagnosis of idiopathic or degenerative scoliosis with curve ≥30 ° Cobb	Other: Questionnaire; Adults with spinal deformities were asked to complete two questionnaires assessing quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical properties of SRS-22 and ISYQOL questionnaire	The Spearman correlation coefficient will be used to evaluate the concurrent validity of ISYQOL questionnaire. Cronbach's alpha will be used to evaluate the internal validity of ISYQOL questionnaire. Rasch analysis will be applied to explore the characteristics of the two tools. In addition, the reproducibility of the measurement. Usually, the goal is to obtain a reliability> 0.8.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: A-ISYQOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data will be uploaded to public repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No