Postoperative Recovery in Elderly Patients Assessed With QoR-15E

Официальное название

Postoperative Quality of Recovery in Elderly Patients Undergoing Elective Surgery With Hospital Admission: a Multicenter Prospective Cohort Study Based on Patient-reported Outcome Measures (PQoRE Study)

Обзор

Postoperative recovery in elderly patients is an important part of the surgical process and affects how patients feel after surgery. To date, recovery has been measured mostly with clinical outcomes, such as complications or length of stay, but not from the patient's perspective. The QoR-15 questionnaire was designed to assess recovery from the patient's point of view and has recently been validated in Spanish as the QoR-15E. This study aims to evaluate postoperative recovery in patients aged 80 years and older undergoing elective surgery with hospital admission, using the QoR-15E questionnaire. Patients will complete the questionnaire before surgery and on postoperative days 1, 2, 7, and 30. Additional assessments will include frailty and delirium scales, and postoperative complications will be recorded. Mortality will be evaluated 90 days after surgery, alongside the patient's subjective perception of their recovery.

Вмешательства

• Диагностический тест QoR-15E questionnaire.
  A first QoR-15E questionnaire will be completed at baseline (T0) (before surgery). Other QoR-15E questionnaires will be completed at 24h (T1), 48h (T2), day 7 (T3) and day 30 (T4) after surgery.
• Диагностический тест Clinical Frailty Scale
  The Clinical Frailty Scale will be administered before surgery to determine patients' clinical fragility
• Другое Confusional Assessment Method
  We will use the "Confusional Assessment Method" to assess the presence of confusion or delirium in the immediate postoperative period.
• Другое Post-Operative Morbidity Survey
  Postoperative morbidity will be collected through the POMS survey.

Первичные конечные точки

• Postoperative quality of recovery (QoR-15E) [Срок оценки: Preoperatively and on postoperative days 1, 2, 7, and 30]

Вторичные конечные точки (3)

• Problems interfering with postoperative recovery assessed by the QoR-15E questionnaire. [Срок оценки: Preoperatively and on postoperative days 1, 2, 7, and 30]
• Contribution to optimization of ERAS and Multimodal Rehabilitation programs assessed by QoR-15E and clinical recovery indicators [Срок оценки: Preoperatively and on postoperative days 1, 2, 7, and 30]
• Contribution to clinical decision-making based on QoR-15E recovery scores [Срок оценки: Preoperatively and on postoperative days 1, 2, 7, and 30]

Критерии участия

Критерии включения

• Patients aged 80 years or older.
• Undergoing elective surgery requiring hospital admission.
• Able to understand and provide written informed consent.

Критерии исключения

• Inability to speak Spanish.
• Pre-existing cognitive impairment.
• Emergency or urgent surgery.
• Neurosurgical or cardiac surgical procedures.
• Ambulatory (outpatient) surgery without hospital admission.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 4 центра

• Hospital del Mar de Barcelona — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Clinic de Barcelona — Barcelona
• Hospital de la Santa Creu i Sant Pau — Barcelona

Публикации

• Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17. PMID 36414472
• Pelavski AD, Lacasta A, de Miguel M, Rochera MI, Roca M. Mortality and surgical risk assessment among the extreme old undergoing emergency surgery. Am J Surg. 2013 Jan;205(1):58-63. doi: 10.1016/j.amjsurg.2012.03.008. Epub 2012 Jul 15. PMID 22795861
• Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7. PMID 17689808
• Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21. PMID 29605019
• Carter HE, Winch S, Barnett AG, Parker M, Gallois C, Willmott L, White BP, Patton MA, Burridge L, Salkield G, Close E, Callaway L, Graves N. Incidence, duration and cost of futile treatment in end-of-life hospital admissions to three Australian public-sector tertiary hospitals: a retrospective multicentre cohort study. BMJ Open. 2017 Oct 16;7(10):e017661. doi: 10.1136/bmjopen-2017-017661. PMID 29038186
• Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13. PMID 35033845
• 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
• Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PMID 29397134

Идентификаторы

NCT: NCT07505758 · PR(AG)06/2024 · ISCIII grant PI24/00712

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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