Validation of the QoR-15 Score for Emergency Surgery

NCT ID: NCT04845763

Last Updated: 2021-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 375 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-05-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

Each patient complete the french version of the QoR-15 score (FQoR-15) at 3 times (before surgery, on Day 1, on Day 2).

FQoR-15 questionnaire

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old,
• French speaking,
• Admitted for any type of urgent surgery (time to surgery < 72 hours) traumaor not
• Able to answer the questionnaire at hospital admission, alone or with the help of a third party,
• And agreeing to participate in the study.

Exclusion Criteria

• Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
• Patients admitted for cardiac surgery or obstetrical surgery (caesarean section),
• Patients admitted for revision surgery,
• Patients already included in the study during a previous admission.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Maxime Léger, MD

Role: CONTACT

maxime.leger@chu-angers.fr

2 41 35 36 35 ext. +33

Béatrice Gable

Role: CONTACT

begable@chu-angers.fr

2 41 35 68 25 ext. +33

References

Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.

Reference Type: BACKGROUND

PMID: 32654751 (View on PubMed)

Le Bescond V, Petit-Phan J, Campfort M, Nicolleau C, Conte M, Bouhours G, Rony L, Lasocki S, Leger M. Validation of the postoperative Quality of Recovery-15 questionnaire after emergency surgery and association with quality of life at three months. Can J Anaesth. 2024 May;71(5):590-599. doi: 10.1007/s12630-024-02722-4. Epub 2024 Mar 19.

Reference Type: DERIVED

PMID: 38504036 (View on PubMed)

Other Identifiers

FQoR-15U

Identifier Type: -

Identifier Source: org_study_id