Clinical trial NCT04699500: Spanish Validation and Cross-cultural Adaptation of the QoR-15E
Official title: Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humans
Reproducibility of Results
Cross-Cultural Comparison
Surveys and Questionnaires
Postoperative Period
Anesthetics
Perception
Keywords: Quality
Recovery
Anesthesia
Validation
Adaptation
Spanish
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Comitè Ètic d'Investigació Clínica HUVH
Study officials:
affiliation: Hospital Vall d'Hebron
name: Susana Manrique Muñoz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: Miriam de Nadal Clanchet, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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. doi: 10.1093/oxfordjournals.bja.a013366.
citation: 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.
citation: 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.
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. Spanish.
citation: 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.