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OpenTrials
Completed

NCT Number: NCT05360199

Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?

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

Completed

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Key information

Conditions

Degenerative Diseases, Spinal Cord Nervous System Diseases Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitário São João, Porto, Portugal

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROMs

Behavioral

evaluate the impact of recall bias on post proms scores

Primary outcomes

  1. Median COMI score results

    Time frame: 4 weeks

    Core outcome measures index. Scale 0 to 10 where 0 means the best score

Secondary outcomes

  1. Median ODI score

    Time frame: 4 weeks

    Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score

  2. Median EQ-5D score

    Time frame: 4 weeks

    EuroQol 5 D where 1 is the best score and -0,500 the worst score

  3. Median NDI

    Time frame: 4 weeks

    Neck disability index Scale 0 to 100 where 0 means the worst score

Sponsors and collaborators

Lead sponsor

Centro Hospitalar De São João, E.P.E.

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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