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

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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).

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Project description:PurposeTo contextualize the Forgotten Joint Score (FJS-12) by identifying a patient acceptable symptomatic state (PASS) threshold for patients undergoing hip arthroscopy and to investigate factors which correlated with postoperative FJS-12 score.MethodsAll patients who underwent hip arthroscopy for femoroacetabular impingement (FAI) under the care of a single surgeon between January 2018 and November 2019 were prospectively identified and included. Exclusion criteria were Tönnis classification grade 2 or greater. Data (including FJS-12, EuroQol-5 Dimension-5L [EQ-5D-5L], visual analog scale (VAS), and 12-item International Hip Outcome Tool (iHOT-12) scores) were available before surgery and at a minimum of 1 year after surgery. PASS was calculated using an anchor-based approach and receiver operator characteristic curve analysis. Pearson correlation analysis was used to correlate preoperative and postoperative factors with postoperative FJS-12 score.ResultsSeventy-seven patients (54 female, 23 male; mean age 30.3 years [standard deviation {SD} 8.2]) were included. Linked longitudinal follow-up data were available for 65 patients (84%) at a mean of 23.8 months (SD 6.4). Six patients required reoperation. Mean postoperative FJS-12 score was 46.5 (SD 33.1) and mean change in score was 27.2 (SD 30.6, P < .001). The PASS threshold for the FJS-12 was 38.5 (sensitivity 80%, specificity 88%), and the area under the curve was 0.852 (95% confidence interval 0.752-0.951). Overall, 53.8% of patients achieved this score. Postoperative FJS-12 score has moderate correlations with preoperative EQ-5D-5L, iHOT-12, and FJS-12 scores, and strong correlations with EQ-5D-5L, iHOT-12 and VAS scores after surgery.ConclusionsWe report a postoperative PASS threshold of 38.5 points for the FJS-12 after hip arthroscopy for FAI in a United Kingdom population. This value can act as a quantifiable target for clinicians using the FJS-12 to monitor patient outcomes in practice. FJS-12 has strong correlations with EQ-5D-5L, iHOT-12, and VAS at a minimum 12 months after surgery.Clinical relevanceWe have calculated the patient acceptable symptomatic state of the Forgotten Joint Score to be 38.5 points at short-term follow-up. This can assist clinicians in determining whether surgical interventions related to hip arthroscopy for FAI are meaningful to the patient.