NCT04845763

Validation of the QoR-15 Score for Emergency Surgery

Validation of the QoR-15 Score for Assessing Quality of Recovery From Emergency Surgery and Its Association With Long-term Quality of Life.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 375 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery. Different scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery. All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.

Detailed description

Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. This event is a source of stress, anxiety, pain, and even complications, both minor (nausea, vomiting) and major (such as surgical revision). The perioperative management and the psychological support allocated to each patient will have an impact on the hospitalization experience. In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery. Most clinical studies are interested in the reduction of perioperative morbidity and mortality (e.g. decrease in pain intensity measured by a visual analog scale, decrease in the frequency of nausea/vomiting, decrease in the time to remobilization, etc.) but still few of them evaluate in a global way the recovery, in particular in the emergency context. Currently there is a desire to improve the physical and psychological recovery of our patients. In this context, scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery. All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.

Conditions

• Quality of Recovery
• Perioperative Complication
• Anesthesia
• Patient Reported Outcome Measures
• Surgery
• Postoperative Complications
• Emergency Surgery

Interventions

Type	Name	Description
OTHER	FQoR-15 questionnaire	The FQoR-15 questionnaire (French version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. In the case of ambulatory surgery, the patient is contacted by telephone to answer the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-03-01
• Completion: 2022-05-01
• First posted: 2021-04-15
• Last updated: 2021-04-15