Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?

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

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

Study Overview

• Status: Completed
• Conditions: Degenerative Diseases, Spinal Cord
• Intervention / Treatment: Behavioral: PROMs

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal
    • Centro Hospitalar Universitário São João
  • Portugal, Portugal
    • Centro Hospitalar Universitário São João

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group; no recall PROMs group ; without knowledge of previous PROMs scores
ACTIVE_COMPARATOR: intervention group; recall PROMs group ; with knowledge of previous PROMs scores	Behavioral: PROMs; evaluate the impact of recall bias on post proms scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median COMI score results	Core outcome measures index. Scale 0 to 10 where 0 means the best score	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median ODI score	Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score	4 weeks
Median EQ-5D score	EuroQol 5 D where 1 is the best score and -0,500 the worst score	4 weeks
Median NDI	Neck disability index Scale 0 to 100 where 0 means the worst score	4 weeks

Collaborators and Investigators

• Sponsor: Centro Hospitalar De São João, E.P.E.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): September 15, 2021
• Study Completion (ACTUAL): October 15, 2021

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (ACTUAL): May 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: PROM; Recall bias
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Bone Diseases; Neurodegenerative Diseases; Spinal Diseases
• Other Study ID Numbers: CHSJ1989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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