A Primer on Clinically Important Outcome Values

Cepeda, Nicholas A; Polascik, Breanna A.; Ling, Daphne

doi:10.2106/jbjs.19.00817

Cited by 21 publications

(22 citation statements)

References 40 publications

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“…22 Group-level differences between PROM scores do not guarantee a perceptible or clinically meaningful difference for individual patients. [7][8][9] As an alternative, CIOVs translate PROM scores into clinically relevant terms and therefore may provide better benchmarks for individual patient success. [7][8][9] Bodendorfer et al 4 reported PASS scores for the question ''Do you consider that your current state is satisfactory?''…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9] As an alternative, CIOVs translate PROM scores into clinically relevant terms and therefore may provide better benchmarks for individual patient success. [7][8][9] Bodendorfer et al 4 reported PASS scores for the question ''Do you consider that your current state is satisfactory?'' in patients at 1 year after hip arthroscopy for FAIS.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of the PROMIS and iHOT-12 in Determining Satisfaction Levels After Hip Arthroscopy for FAIS

Martin

Harris

Ellis

et al. 2023

Orthopaedic Journal of Sports Medicine

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Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) has not been fully evaluated for outcomes assessment after hip arthroscopy to correct femoroacetabular impingement syndrome (FAIS). Purpose/Hypothesis: The purpose of this study was to compare the accuracy of the PROMIS Physical Function (PF) and Pain Interference (PI) subscales with the 12-Item International Hip Outcome Tool (iHOT-12) to define patients with 3 unique substantial clinical benefit (SCB) scores—patients who reported ≥80%, ≥90%, and 100% satisfaction at 1 year after hip arthroscopy for FAIS. We hypothesized that the iHOT-12 would be more accurate than the PROMIS-PF and PROMIS-PI subscales in identifying these 3 patient groups. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: We reviewed the records of patients who underwent hip arthroscopy for symptomatic FAIS at 3 centers from January 2019 through June 2021 and had 1-year clinical and radiographic follow-up data. Patients completed the iHOT-12, PROMIS-PF, and PROMIS-PI on initial assessment and at 1 year (±30 days) postoperatively. Postoperative satisfaction was reported on an 11-category scale with anchors defined as “0% satisfied” and “100% satisfied.” Receiver operator characteristic analysis was performed to determine the absolute SCB values for the iHOT-12 and PROMIS subscales that would most accurately identify those patients who reported ≥80%, ≥90%, and 100% satisfaction. Area under the curve (AUC) values and 95% CIs for the 3 instruments were compared. Results: Included were 163 patients (111 [68%] women and 52 [32%] men), with a mean age of 26.1 years. Corresponding absolute SCB scores for patients who reported ≥80%, ≥90%, and 100% satisfaction were as follows: iHOT-12, 68.4, 72.1, 74.7; PROMIS-PF, 45, 47.7, 49.9; and PROMIS-PI, 55.9, 52.4, 51.9. The AUC ranged between 0.67 and 0.82, with overlapping 95% CIs indicating a minimal difference in accuracy between the 3 instruments. Sensitivity and specificity values ranged between 0.61 and 0.82. Conclusion: The PROMIS-PF and PROMIS-PI subscales were as accurate as the iHOT-12 in defining absolute SCB scores for patients reporting ≥80%, ≥90%, and 100% satisfaction at 1-year follow-up after hip arthroscopy for FAIS.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Comparison of the PROMIS and iHOT-12 in Determining Satisfaction Levels After Hip Arthroscopy for FAIS

Martin

Harris

Ellis

et al. 2023

Orthopaedic Journal of Sports Medicine

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“…This score is derived from 5 items, each having five response options. To determine the PASS of the MHQ pain score, we asked patients to answer the following anchor question [ 23 ]: “How satisfied are you with your treatment results thus far?” with response options: “excellent,” “good,” “fair,” “moderate,” or “poor.” Considering that the PASS represents the threshold above which a patient is satisfied with his or her current state [ 3 ], we adopted the threshold between “fair” and “good” as the PASS and dichotomized the ratings accordingly.…”

Section: Methodsmentioning

confidence: 99%

“…with response options: "excellent," "good," "fair," "moderate," or "poor." Considering that the PASS represents the threshold above which a patient is satisfied with his or her current state [3], we adopted the threshold between "fair" and "good" as the PASS and dichotomized the ratings accordingly.…”

Section: Real Dataset: Patient Acceptable Symptom State (Pass)mentioning

confidence: 99%

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Estimating meaningful thresholds for multi-item questionnaires using item response theory

et al. 2023

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Purpose Meaningful thresholds are needed to interpret patient-reported outcome measure (PROM) results. This paper introduces a new method, based on item response theory (IRT), to estimate such thresholds. The performance of the method is examined in simulated datasets and two real datasets, and compared with other methods. Methods The IRT method involves fitting an IRT model to the PROM items and an anchor item indicating the criterion state of interest. The difficulty parameter of the anchor item represents the meaningful threshold on the latent trait. The latent threshold is then linked to the corresponding expected PROM score. We simulated 4500 item response datasets to a 10-item PROM, and an anchor item. The datasets varied with respect to the mean and standard deviation of the latent trait, and the reliability of the anchor item. The real datasets consisted of a depression scale with a clinical depression diagnosis as anchor variable and a pain scale with a patient acceptable symptom state (PASS) question as anchor variable. Results The new IRT method recovered the true thresholds accurately across the simulated datasets. The other methods, except one, produced biased threshold estimates if the state prevalence was smaller or greater than 0.5. The adjusted predictive modeling method matched the new IRT method (also in the real datasets) but showed some residual bias if the prevalence was smaller than 0.3 or greater than 0.7. Conclusions The new IRT method perfectly recovers meaningful (interpretational) thresholds for multi-item questionnaires, provided that the data satisfy the assumptions for IRT analysis.

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Conditional Minimal Detectable Change for the Cochlear Implant Quality of Life-35 Profile Associated With Improved Functional Abilities 12 Months After Cochlear Implantation

McRackan

Seamon

Shannon

et al. 2023

JAMA Otolaryngol Head Neck Surg

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ImportanceIt is essential to measure an individual patient’s baseline and follow-up abilities to demonstrate changes in clinical outcomes over time. Inherent in this strategy is interpreting whether the measured change is clinically significant and beyond measurement error. Conditional minimal detectable change (cMDC) values are widely used in many disciplines but have rarely been established for outcome measures in otolaryngology or hearing research, and never in cochlear implantation.ObjectiveTo determine cMDC values for the Cochlear Implant Quality of Life-35 (CIQOL-35) Profile instrument to enhance our understanding of the initial and ongoing changes in functional abilities from cochlear implants (CIs).Design, Setting, and ParticipantsItem response theory analyses of responses from a multi-institutional cohort of 705 CI users at a tertiary CI center were used to derive standard error (SE) values for each possible CIQOL-35 domain score. Using an iterative approach, these SE values were used to calculate cMDC values for every possible pre-CI and post-CI domain score combination. We then compared pre-CI to 12-month post-CI CIQOL-35 domains scores in an independent cohort of 65 adult CI users to determine whether the measured change exceeded error to be clinically significant. The analysis took place on December 14, 2022.InterventionsThe CIQOL-35 Profile instrument and cochlear implantation.ResultsThe cMDC values were smaller for the communication domain, and global measure and cMDC values for all domains were larger at the extremes of the measurement scale. Overall, 60 CI users (92.3%) demonstrated improvement beyond cMDC at 12 months post-CI for at least 1 CIQOL-35 domain, and no patients’ scores declined beyond cMDC for any domain. The percentage of CI users demonstrating improvement beyond cMDC varied by domain, with communication (53 [81.5%]) showing the largest number of CI users improving, followed by global (42 [64.6%]) and entertainment (40 [60.9%]). In general, CI users who demonstrated improvement in CIQOL-35 domains had greater improvement in speech recognition scores than patients who did not, but the strength and significance of these associations greatly varied by domain and speech material.Conclusions and RelevanceThis multistep cohort study found that cMDC values for the CIQOL-35 Profile provided personalized thresholds for detecting real changes in patient self-reported functional abilities over time across multiple domains, which may inform clinical decision-making. Moreover, these longitudinal results reveal the domains with more or less improvement, which may aid in patient counseling.

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A Primer on Clinically Important Outcome Values

Cited by 21 publications

References 40 publications

Comparison of the PROMIS and iHOT-12 in Determining Satisfaction Levels After Hip Arthroscopy for FAIS

Comparison of the PROMIS and iHOT-12 in Determining Satisfaction Levels After Hip Arthroscopy for FAIS

Estimating meaningful thresholds for multi-item questionnaires using item response theory

Conditional Minimal Detectable Change for the Cochlear Implant Quality of Life-35 Profile Associated With Improved Functional Abilities 12 Months After Cochlear Implantation

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