Spanish Validation and Cross-cultural Adaptation of the QoR-15E

NCT04699500 | Completed

• 1 other identifier: PR(AG)620/2020
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.

Conditions

Humans; Reproducibility of Results; Cross-Cultural Comparison; Surveys and Questionnaires; Postoperative Period; Anesthetics; Perception

Keywords

Quality; Recovery; Anesthesia; Validation; Adaptation; Spanish

Outcome Measures

Primary Outcomes (1)

• Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E.

  The aim of this study is to carry out cross-cultural adaptation and validate the postoperative questionnaire QoR-15 to the Spanish environment and evaluate its validity and reliability. This questionnaire consists of 15 items with a total score of 150 points where 150 points is better than 0 points for the patient.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population will be made up of adult patients who undergo a surgical intervention as a therapeutic or diagnostic procedure (general surgery, urology and gynecology) that require an anesthetic technique in the General Area of the Vall d'Hebron University Hospital, whose intended destination after the procedure would be the post-anesthetic recovery unit, before hospital discharge

You may qualify if:

• Patients over 18 years old.
• Comprehensive and sign informed consent.
• Knows and understands the Spanish language.
• Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology and gynecology.
• Score \> 26 points in the Mini Mental State Examination (MMSE) test.

You may not qualify if:

• Patients under 18 years old.
• Not having signed the informed consent.
• Not knowing or understanding the Spanish language.
• Surgical intervention from other specialties than general surgery, urology and gynecology.
• Score \< 27 points in the Mini Mental State Examination (MMSE) test.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Comitè Ètic d'Investigació Clínica HUVH

Barcelona, 08035, Spain

Location

Related Publications (6)

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand. 2015 Aug;59(7):912-20. doi: 10.1111/aas.12525. Epub 2015 Apr 13.

  PMID: 25867135 BACKGROUND

• Sa AC, Sousa G, Santos A, Santos C, Abelha FJ. Quality of Recovery after Anesthesia: Validation of the Portuguese Version of the 'Quality of Recovery 15' Questionnaire. Acta Med Port. 2015 Sep-Oct;28(5):567-74. doi: 10.20344/amp.6129. Epub 2015 Oct 30.

  PMID: 26667859 BACKGROUND

• Llamas-Velasco S, Llorente-Ayuso L, Contador I, Bermejo-Pareja F. [Spanish versions of the Minimental State Examination (MMSE). Questions for their use in clinical practice]. Rev Neurol. 2015 Oct 16;61(8):363-71. Spanish.

  PMID: 26461130 BACKGROUND

• Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.

  PMID: 32303379 BACKGROUND

Study Officials

• Susana Manrique Muñoz, MD, PhD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

• Miriam de Nadal Clanchet, MD, PhD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: December 2, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 31, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

ES (1)