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In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians.
Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway.
However data about the efficacy of PROMs-based perioperative clinical follow up are lacking.
The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.
The study is a multicenter randomized controlled trial comparing 2 groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group: OPTIMISTIC follow-up | Experimental | follow-up by nurses specialized in collecting the patient's point of view concerning his or her state of health, in addition to the usual conventional follow-up according to routine care directive interviews carried out preoperatively and at Days 1, 3, 14 and 28 postoperatively (modified QoR-15f score, PROMS...) |
|
| Control group: Usual conventional follow-up | Active Comparator | usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group: OPTIMISTIC follow-up | Behavioral | follow-up by nurses specialized in collecting the patient's point of view concerning his or her state of health, in addition to the usual conventional follow-up according to routine care directive interviews carried out preoperatively and at Days 1, 3, 14 and 28 postoperatively (modified QoR-15f score, PROMS...) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management | Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the intraoperative consultation and D35 postoperative | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe postoperative functional recovery after osteoarticular surgery | Isolated and dimensional changes in the 15 items of the QoR-15f score from intraoperative consultation to postoperative D35. | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35 |
| Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EBER Manon, Mme | CHRU Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EBER Manon | Strasbourg | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42290213 | Derived | Eber M, Perrin T, Reinbold N, Diemunsch S, Bonnomet F, Pottecher J, Bennett-Guerrero E, Chahard A, Meyer N, Noll E. Patient-reported outcome measures-guided perioperative care versus standard of care in postoperative recovery: Randomised controlled trial in orthopaedic surgery. Eur J Anaesthesiol. 2026 Jun 9. doi: 10.1097/EJA.0000000000002429. Online ahead of print. |
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|
| Control group: Usual conventional follow-up | Other | usual conventional follow-up according to routine care (modified QoR-15f score will be administered to all patients at visit 0 and Day 35). |
|
Number of medical and paramedical consultations and number of hospitalization days between hospital discharge and D35 postoperative |
| Day 1, Day 3, Day 14, Day 28 and Day 35 |
| Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use | Opioid consommation at D35 postoperative | Day 35 |
| Evaluate the safety | postoperative complication rate to postoperative D35 | Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35] |