Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?

Degenerative Diseases, Spinal Cord Clinical Trial

Official title:

Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360199
• Other study ID #: CHSJ1989
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: April 2022
• Source: Centro Hospitalar De São João, E.P.E.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients with valid preoperative PROM scores submitted to spine surgery due to degenerative pathology from January 2019 to April 2020 at our center (spine unit of a neurosurgical department in a Portuguese university hospital) were included in the study and received PROMs questionnaires with a letter of consent.

Exclusion Criteria:

• Patients without valid preoperative questionnaires were excluded from the study while patients were lost to follow-up if mail questionnaires were not completed two months after PROMs remittance or if they had submitted incomplete or invalid answers.

Related Conditions & MeSH terms

• Degenerative Diseases, Spinal Cord
• Neurodegenerative Diseases
• Spinal Diseases

Intervention

Behavioral:
• PROMs
evaluate the impact of recall bias on post proms scores

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário São João	Porto
Portugal	Centro Hospitalar Universitário São João	Portugal

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar De São João, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median COMI score results	Core outcome measures index. Scale 0 to 10 where 0 means the best score	4 weeks
Secondary	Median ODI score	Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score	4 weeks
Secondary	Median EQ-5D score	EuroQol 5 D where 1 is the best score and -0,500 the worst score	4 weeks
Secondary	Median NDI	Neck disability index Scale 0 to 100 where 0 means the worst score	4 weeks