The SPINEREG study is a prospective observational registry. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps.
The SPINEREG study is a prospective observational study. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps. Data from surgery and patients PROMs are registered on the database; the main timepoints are: pre-surgery, surgery, 3-6 month after surgery, 1-2-5-10-15-20 years after surgery.
Study Type
OBSERVATIONAL
Enrollment
10,000
Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy
RECRUITINGSpinal function (Oswestry Disability Index score)
Oswestry Disability Index score (ODI). Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: 1 years
Reliability of the data collected in SpineReg
This project was based on the retrospective analysis of patients prospectively enrolled in a spinal surgery registry, SpineREG. The study aims to evaluate the equivalence of the PROMs registered in SpineREG using two different formats: paper vs. electronic version. Through the comparison between the data electronically provided in SpineREG and the paper questionnaires, the accuracy, reliability and validity of the data were evaluated.
Time frame: 6 months
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