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

Humans Clinical Trial

Official title:

Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699500
• Other study ID #: PR(AG)620/2020
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 31, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Comitè Ètic d'Investigació Clínica HUVH	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

Kleif J, Edwards HM, Sort R, Vilandt J, Gögenur 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. — View Citation

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. Review. Spanish. — View Citation

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. — View Citation

Sá 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. Epub 2015 Oct 30. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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