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Minimal Clinically Important Changes of Patient-reported Outcome Measures for Acute Postsurgical Pain
Jan Vollert1, Vasco M Egert2, Daniel Segelcke3
1Department of Clinical and Biomedical Sciences, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom; and Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.
Background:
Patient-reported outcome measures (PROMs) are essential instruments for assessing postsurgical pain-related outcomes from the patient's perspective. The concept of minimal clinically important difference (MCID) aims to identify the smallest change in PROMs that is meaningful to patients. In this multicenter study, data were used to calculate MCIDs for several PROMs assessing pain intensity and physical function after surgery and to perform a sensitivity analysis.
Methods:
Data from 2,661 patients undergoing sternotomy, total knee arthroplasty, breast surgery, or surgery related to endometriosis, recruited from 18 centers in 10 European countries, were included in the analysis. Eight PROMs were collected on days 1 and 3 after surgery, assessing pain intensity (at rest, average, worst, during movement, during physiotherapy) and physical function (in bed, during movement, during physiotherapy). MCIDs were calculated using a combination of distribution-based (30% of SD, standard error of the measurement) and anchor-based (calculating the absolute change between day 1 and day 3 for patients reporting "minimal improvement" or "minimal worsening" on 7-point global and specific impression of change scales) methods.
Results:
The MCID estimates for pain intensity ranged from 1.2 (at rest) to 1.6 (during activity), while physical function was consistent between 1.5 (in bed) and 1.6 (during physiotherapy) on an 11-point scale. Sensitivity analyses revealed no significant difference in MCID estimates between symptom improvement and worsening for all PROMs. However, baseline pain influenced MCID estimates, with higher baseline pain leading to patients reporting higher changes as meaningful ( e.g. , for pain at rest, MCID mild pain 1.0, MCID severe pain 2.1).
Conclusions:
The authors found differences between MCID estimates for eight PROMs related to pain intensity and physical function. Baseline values appear to have a significant impact on what patients consider to be a minimal relevant change, which should be addressed in future studies.
Insights
This study calculated minimal clinically important differences (MCID) for patient-reported outcome measures (PROMs) after surgery. Baseline pain significantly impacts what patients consider a meaningful change in pain and function.
Area of Science:
- Surgical Outcomes Research
- Patient-Reported Outcome Measures (PROMs)
- Clinical Significance Assessment
Background:
- Patient-reported outcome measures (PROMs) are crucial for evaluating postsurgical pain and function from the patient's viewpoint.
- Minimal Clinically Important Difference (MCID) quantifies the smallest change in PROMs that patients perceive as meaningful.
- Understanding MCID is vital for interpreting treatment effectiveness and guiding clinical decisions.
Purpose of the Study:
- To calculate MCID values for various PROMs assessing postsurgical pain intensity and physical function.
- To conduct a sensitivity analysis of MCID estimates.
- To investigate the influence of baseline pain severity on MCID values.
Main Methods:
- A multicenter study involving 2,661 patients across 10 European countries.
- Data collected on days 1 and 3 post-surgery for eight PROMs measuring pain and physical function.
- MCIDs were determined using a combined distribution-based and anchor-based approach.
Main Results:
- MCID estimates for pain intensity ranged from 1.2 to 1.6; for physical function, they ranged from 1.5 to 1.6 (on an 11-point scale).
- Sensitivity analyses showed no significant differences in MCID between symptom improvement and worsening.
- Higher baseline pain correlated with higher MCID values, indicating patients with severe pain require a larger change to perceive improvement.
Conclusions:
- Significant differences exist in MCID estimates for PROMs related to pain and physical function.
- Baseline pain levels substantially influence patients' perception of a minimal relevant change.
- Future research should consider baseline values when interpreting MCID in postsurgical patients.
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