Back to resultsAre Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?
Primary Purpose
Degenerative Diseases, Spinal Cord
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
PROMs
Sponsored by
About this trial
This is an interventional health services research trial for Degenerative Diseases, Spinal Cord focused on measuring PROM, Recall bias
Eligibility Criteria
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.
Sites / Locations
- Centro Hospitalar Universitário São João
- Centro Hospitalar Universitário São João
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
intervention group
Arm Description
no recall PROMs group ; without knowledge of previous PROMs scores
recall PROMs group ; with knowledge of previous PROMs scores
Outcomes
Primary Outcome Measures
Median COMI score results
Core outcome measures index. Scale 0 to 10 where 0 means the best score
Secondary Outcome Measures
Median ODI score
Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score
Median EQ-5D score
EuroQol 5 D where 1 is the best score and -0,500 the worst score
Median NDI
Neck disability index Scale 0 to 100 where 0 means the worst score
Full Information
NCT ID
NCT05360199
First Posted
April 23, 2022
Last Updated
April 28, 2022
Sponsor
Centro Hospitalar De São João, E.P.E.
1. Study Identification
Unique Protocol Identification Number
NCT05360199
Brief Title
Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?
Official Title
Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar De São João, E.P.E.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Diseases, Spinal Cord
Keywords
PROM, Recall bias
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
patients are unaware whether they are in the intervention or control group
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
no recall PROMs group ; without knowledge of previous PROMs scores
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
recall PROMs group ; with knowledge of previous PROMs scores
Intervention Type
Behavioral
Intervention Name(s)
PROMs
Intervention Description
evaluate the impact of recall bias on post proms scores
Primary Outcome Measure Information:
Title
Median COMI score results
Description
Core outcome measures index. Scale 0 to 10 where 0 means the best score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Median ODI score
Description
Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score
Time Frame
4 weeks
Title
Median EQ-5D score
Description
EuroQol 5 D where 1 is the best score and -0,500 the worst score
Time Frame
4 weeks
Title
Median NDI
Description
Neck disability index Scale 0 to 100 where 0 means the worst score
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro Hospitalar Universitário São João
City
Porto
Country
Portugal
Facility Name
Centro Hospitalar Universitário São João
City
Portugal
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
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Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?
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