Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811209
Status:
RECRUITING
Last Update Posted:
2021-03-23
First Post:
2021-03-17
Brief Title:
MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Determining the Minimum Clinically Important Difference MCID and Patient Acceptable Symptom State PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery
Detailed Description:
Acute postoperative pain after orthopaedic surgery is common and approximately 40 of all surgical patients experience moderate-severe acute postoperative pain Treatment of acute pain after surgery is important to relieve patient suffering expedite resumption of activities of daily living mitigate the risk of postoperative complications speed ambulation and rehabilitation and hospital discharge Good pain treatment requires proper and sound pain assessment to guide analgesic therapy Past studies have determined the MCID values for a variety of chronic pain disorders There are however limited data on the MCID for acute painAt the present time most perioperative acute pain studies use MCID values that are extrapolated from chronic pain studies yet the validity of MCID extrapolation remains unknown Procedure-specific MCID for pain after most major orthopedic surgery has not been reportedThe MCID for a patient reported outcome can be determined using an anchor and a distribution based methodThe anchor based method uses a subjective Global Rating Scale GRS scale to assess patients perception of pain relief after treatment This is a 15-point Likert scale that ranges from -7 to 7 Another method to determine the MCID value in pain is the distribution based method using mathematical calculations to generate 3 MCID values - 1 03 standard deviation SD of mean change in NRS scores 2 the standard error of measurement SEM and 3 5 of the instrument range of the mean change in the NRS scores after an analgesic intervention according to patient-rated GAR scale The SEM is calculated as the SD multiplied by the square root of 1 minus the intraclass correlation coefficient The final MCID value is the average of 4 values 1 generated from the anchored and 3 generated from the distribution based methods
The Patient Acceptable Symptom State PASS is another measure for patient-reported outcomes It represents the threshold beyond which patients consider themselves well satisfied after an intervention The PASS is an absolute value not a change but this value will vary among patients In essence PASS indicates a state of wellbeing feeling good as opposed to MCID a state of improvement feeling better The 2 concepts are complementary but contrary to MCID the PASS is the outcome of interest instead of the extent of improvement To determine PASS the patients are asked this question In your opinion do you consider your current pain state satisfactory after your operation Patients responding yes are considered having an acceptable pain state The PASS is the 75th centile of the pain scale in those who rated their pain state as satisfactory Higher baseline pain scores are often associated with higher PASS estimates Little is known about PASS for acute pain after surgery thus a need to determine this benchmark to properly evaluate the clinical benefits of analgesic interventions
Quality of Recovery QoR is another important PRO measure when evaluating the impact of novel intervention strategies Quality of recovery can be assessed using the QoR-15 questionnaire scores 0-150 which measures physical mental well-being as an indication of the quality of recovery after surgery and anaesthesia
To determine MCID for QoR both the anchor and distribution based methods will be used The patient will be asked How would you rate your overall recovery from surgery since yesterday Patients will use the same GRS -7 to 7 to measure their response With the anchored-based method the MCID is the mean change in the QoR-15 score when the patient reports a GRS score of 2 or 3 The distribution-based method will generate 3 other MCID values 1 03 standard deviation SD of the mean change in the QoR score 2 the standard error of measurement SEM and 3 5 of the instrument range Again the final MCID value is the average of 4 values 1 generated from the anchored and 3 generated from the distribution based methods
To determine PASS for QoR the patients will be asked In your opinion have you made a good recovery from your operation with response options of yes no or unsure Those who give a positive response is considered having made a good recovery The PASS for QoR is the 75th centile of the QoR-15 score in those who rated their recovery as good The only MCID and PASS study by Myles reported a QoR-15 score of 8 118 out of 150 respectively in patients undergoing a broad range of surgical procedures Procedure-specific MCID PASS for QoR-15 after major orthopaedic surgery are currently unknown Our proposed observational study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery
The Patient Acceptable Symptom State PASS is another measure for patient-reported outcomes It represents the threshold beyond which patients consider themselves well satisfied after an intervention The PASS is an absolute value not a change but this value will vary among patients In essence PASS indicates a state of wellbeing feeling good as opposed to MCID a state of improvement feeling better The 2 concepts are complementary but contrary to MCID the PASS is the outcome of interest instead of the extent of improvement To determine PASS the patients are asked this question In your opinion do you consider your current pain state satisfactory after your operation Patients responding yes are considered having an acceptable pain state The PASS is the 75th centile of the pain scale in those who rated their pain state as satisfactory Higher baseline pain scores are often associated with higher PASS estimates Little is known about PASS for acute pain after surgery thus a need to determine this benchmark to properly evaluate the clinical benefits of analgesic interventions
Quality of Recovery QoR is another important PRO measure when evaluating the impact of novel intervention strategies Quality of recovery can be assessed using the QoR-15 questionnaire scores 0-150 which measures physical mental well-being as an indication of the quality of recovery after surgery and anaesthesia
To determine MCID for QoR both the anchor and distribution based methods will be used The patient will be asked How would you rate your overall recovery from surgery since yesterday Patients will use the same GRS -7 to 7 to measure their response With the anchored-based method the MCID is the mean change in the QoR-15 score when the patient reports a GRS score of 2 or 3 The distribution-based method will generate 3 other MCID values 1 03 standard deviation SD of the mean change in the QoR score 2 the standard error of measurement SEM and 3 5 of the instrument range Again the final MCID value is the average of 4 values 1 generated from the anchored and 3 generated from the distribution based methods
To determine PASS for QoR the patients will be asked In your opinion have you made a good recovery from your operation with response options of yes no or unsure Those who give a positive response is considered having made a good recovery The PASS for QoR is the 75th centile of the QoR-15 score in those who rated their recovery as good The only MCID and PASS study by Myles reported a QoR-15 score of 8 118 out of 150 respectively in patients undergoing a broad range of surgical procedures Procedure-specific MCID PASS for QoR-15 after major orthopaedic surgery are currently unknown Our proposed observational study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None