Dataset Information

Minimal important difference and patient acceptable symptom state for PFDI-20 and POPDI-6 in POP surgery.

ABSTRACT:

Introduction and hypothesis

Patient-reported outcome measures are fundamental tools when assessing effectiveness of treatments. The challenge lies in the interpretation: which magnitude of change in score is meaningful for the patients? The minimal important difference (MID) is defined as the smallest difference in score that patients perceive as important. The Patient Acceptable Symptom State (PASS) represents the value of score beyond which patients consider themselves well. We aimed to determine the MID and PASS for Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) in pelvic organ prolapse (POP) surgery.

Methods

We used data from 2704 POP surgeries from a prospective, population-based cohort. MID was determined with three anchor-based and one distribution-based method. PASS was defined using two different methods. Medians of the estimates were identified.

Results

The MID estimates with (1) mean change, (2) receiver-operating characteristic (ROC) curve, (3) 75th percentile, and (4) distribution-based method varied between 22.9-25.0 (median 24.2) points for PFDI-20 and 9.0-12.5 (median 11.3) for POPDI-6. The PASS cutoffs with (1) 75th percentile and (2) ROC curve method varied between 57.7-62.5 (median 60.0) for PFDI-20 and 16.7-17.7 (median 17.2) for POPDI-6.

Conclusion

A mean difference of 24 points in the PFDI-20 or 11 points in the POPDI-6 can be used as a clinically relevant difference between groups. Postoperative scores ≤ 60 for PFDI-20 and ≤ 17 for POPDI-6 signify acceptable symptom state.

SUBMITTER: Karjalainen PK

PROVIDER: S-EPMC8642346 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures.MethodsWe recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means.ResultsDepending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH.ConclusionThe study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials.Trial registrationClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

Project description:BackgroundThe results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well.ObjectiveTo determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS).MethodsWe used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100?mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds.ResultsDifferent MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20?mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2?mm for pain at rest, 9?mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83.ConclusionWe recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20?mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9?mm for pain on arm activity, 80 points for CS, and 11 points for SST.Trial registrationClinicalTrials.gov NCT00428870 (first registered January 29, 2007).

Project description:PurposeTo define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptomatic state (PASS) for patient-reported outcome measures (PROMs) after medial patellofemoral ligament reconstruction (MPFLR) and to investigate the role of preoperative, demographic, and intraoperative variables for predicting achievement of these thresholds.MethodsThis retrospective cohort study used a prospectively maintained database of patients undergoing primary MPFLR between August 2015 and December 2019. PROMs included the International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS joint replacement (JR), and Kujala. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. Regression analyses were performed to identify prognosticators for achievement of clinically significant thresholds.Results139 patients met inclusion criteria (mean age: 21.7± 8.2 years). At 6 months, the MCID values were 8.3 (KOOS-Pain) and 8.5/13.5 (Kujala); SCB values were 1.4 (KOOS-Pain) and 43.7 (KOOS-QOL); and PASS values were 64.9 (IKDC), 83.3 (KOOS-Symptom), 76.8 (KOOS-Pain), 91.2 (KOOS-ADL), 47.5 (KOOS-Sport), 40.6 (KOOS-QOL), and 78.1 (KOOS-JR). At 1 year, the MCID values were 4.2 (KOOS-Pain), 7.2 (KOOS-ADL), 12.4 (KOOS-QOL) and 25.2 (KOOS-JR); SCB were 23.6 (IKDC), 4.2 (KOOS-Symptom), 19.7 (KOOS-Pain), 6.5 (KOOS-ADL), 55.0 (KOOS-Sport), 6.3 (KOOS-QOL), and 19.6/25.2 (KOOS-JR); and PASS were 65.5 (IKDC), 80.4 (KOOS-Symptom), 84.7 (KOOS-Pain), 99.3 (KOOS-ADL), 57.5 (KOOS-Sport), 53.1 (KOOS-QOL), and 76.3 (KOOS-JR). In regression analysis, greater age, body mass index, and preoperative PROMs were negative prognosticators for achieving clinically significant thresholds. Conversely, male gender increased the likelihood of achieving PASS for Kujala at 6 months and KOOS-ADL at 1 year.ConclusionsThis study established thresholds for the MCID, SCB, and PASS at 6 months and 1 year after MPFLR, providing physicians an evidence-based method to advise patients and assess outcomes with this surgery. Older patients and those with higher preoperative outcome scores are less likely to report improvement and satisfaction with MPFLR, while male patients are more likely to report some satisfaction.Level of evidenceLevel III, retrospective cohort study (diagnosis).

Project description:BackgroundTwo common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well.MethodsWe recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale.ResultsThe change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively.ConclusionOur study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture.Trial registrationClinicalTrials.gov NCT01719887, first registration 01/11/2012.