Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05360199
Enrollment
236
Registered
2022-05-04
Start date
2021-01-01
Completion date
2021-10-15
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Diseases, Spinal Cord

Keywords

PROM, Recall bias

Brief summary

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

Interventions

BEHAVIORALPROMs

evaluate the impact of recall bias on post proms scores

Sponsors

Centro Hospitalar De São João, E.P.E.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

patients are unaware whether they are in the intervention or control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Median COMI score results4 weeksCore outcome measures index. Scale 0 to 10 where 0 means the best score

Secondary

MeasureTime frameDescription
Median ODI score4 weeksNeck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score
Median EQ-5D score4 weeksEuroQol 5 D where 1 is the best score and -0,500 the worst score
Median NDI4 weeksNeck disability index Scale 0 to 100 where 0 means the worst score

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026