Minimal Clinically Important Difference and Substantial Clinical Benefit Using PROMIS CAT in Cervical Spine Surgery

Steinhaus, Michael E.; Iyer, Sravisht; Lovecchio, Francis; Khechen, Benjamin; Stein, Daniel J.; Ross, Thomas; Yang, Jingyan; Singh, Kern; Albert, Todd J.; Lebl, Darren R.; Huang, Russel C.; Sandhu, Harvinder S.; Rawlins, Bernard A.; Schwab, Frank J.; Lafage, Virginie; Kim, Hee Jin

doi:10.1097/bsd.0000000000000895

Cited by 94 publications

(71 citation statements)

References 33 publications

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“…In particular, many of the early investigations centered on the MCID of the PROMIS Physical Function questionnaire for spine, foot and ankle, and hand surgery. 5,16,32,34 In a psychometric comparison of the PROMIS Physical Function with the ASES score in patients undergoing shoulder arthroplasty, Fu et al 10 found that the PROMIS Physical Function was psychometrically inferior to the ASES and that the PROMIS UE may be a more appropriate PROMIS instrument in patients with shoulder disability. To our knowledge, this is the first study to evaluate clinically significant outcome measures of the PROMIS UE.…”

Section: Discussionmentioning

confidence: 99%

Establishing the Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, and Substantial Clinical Benefit of the PROMIS Upper Extremity Questionnaire After Rotator Cuff Repair

Haunschild

Gilat

et al. 2020

Am J Sports Med

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Background: The Patient-Reported Outcome Measurement Information System Upper Extremity (PROMIS UE) questionnaire has been validated as an effective and efficient outcome measure after rotator cuff repair (RCR). However, definitions of clinically significant outcomes used in interpreting this outcome measure have yet to be defined. Purpose: To define clinically significant outcomes of the PROMIS UE questionnaire in patients undergoing arthroscopic RCR. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: We reviewed charts of consecutive patients undergoing RCR in our institution between 2017 and 2018 and included patients who were administered the PROMIS UE before surgery and 12 months after surgery. At 12 months postoperatively, patients were asked domain-specific anchor questions regarding their function and satisfaction after surgery, which were then used to determine the minimal clinically important difference (MCID), Patient Acceptable Symptomatic State (PASS), and substantial clinical benefit (SCB) using receiver operating characteristic and area under the curve (AUC) analysis. Univariate and multivariate logistic regression analysis was utilized to identify patient factors associated with clinically significant outcomes. Results: A total of 105 patients with RCR and minimum 12-month postoperative PROMIS UE were included in the analysis. The defined clinically significant outcomes were 4.87 for the MCID using a distribution-based method, 7.95 for the SCB (sensitivity, 0.708; specificity, 0.833; AUC, 0.760), and 39.00 for the PASS (sensitivity, 0.789; specificity, 0.720; AUC, 0.815). Among respondents, 79.0%, 62.9%, and 64.8% achieved the MCID, SCB, and PASS score thresholds, respectively. Workers’ compensation was negatively associated with achievement of the PASS. Lower preoperative PROMIS UE scores were associated with obtaining the MCID (odds ratio [OR], 0.871; P = .001) and the SCB (OR, 0.900; P = .040), whereas higher preoperative scores were predictive of achieving the PASS (OR, 1.111; P = .020). Conclusion: This study defines the clinically significant outcomes for the PROMIS UE after RCR, of which the majority of patients achieved the MCID, PASS, and SCB at 12 months after surgery. These thresholds should be considered in future study design and interpretation of PROMIS UE in patients with RCR.

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Section: Discussionmentioning

confidence: 99%

Establishing the Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, and Substantial Clinical Benefit of the PROMIS Upper Extremity Questionnaire After Rotator Cuff Repair

Haunschild

Gilat

et al. 2020

Am J Sports Med

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“…All PROMs were collected preoperatively and at 6 weeks, 12 weeks, 6 months, and 1 year postoperatively. Assessment of significant improvements as perceived by the patient was collected through MCID achievement by comparing the improvement from preoperative to postoperative scores (Delta) with established thresholds from the literature: 2.6 (VAS neck); 20 4.1 (VAS arm); 20 17.3 (NDI); 20 8.1 (SF-12 PCS); 20 4.7 www.e-neurospine.org 379 (SF-12 MCS); 20 4.5 (PROMIS PF); 21 3.0 (PHQ-9). 22…”

Section: Data Collectionmentioning

confidence: 99%

Preoperative Neck Disability Severity Limits Extent of Postoperative Improvement Following Cervical Spine Procedures

et al. 2021

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Objective: Our study aims to evaluate the impact of severity of preoperative Neck Disability Index (NDI) on postoperative patient-reported outcome measures (PROMs). Methods: A retrospective review of primary, elective, single or multilevel anterior cervical discectomy and fusion or cervical disc arthroplasty procedures between 2013 and 2019 was performed. Visual analogue scale (VAS) neck and arm, NDI, 12-item Short Form physical and mental composite score (SF-12 PCS and MCS), Patient-Reported Outcome Measurement Information System physical function, and 9-item Patient Health Questionnaire (PHQ-9) were collected preoperatively and postoperatively. Patients were categorized by preoperative NDI: none-to-mild disability ( < 30); moderate disability ( ≥ 30 to < 50); severe disability ( ≥ 50 to < 70); complete disability ( ≥ 70). The impact of preoperative NDI on PROM scores and minimum clinically important difference (MCID) achievement rates were evaluated. Results: The cohort included 74 patients with none-to-mild disability, 95 moderate, 76 severe, and 17 with complete disability. Patients with greater preoperative disability demonstrated significantly different scores for NDI, VAS neck, SF-12 MCS, and PHQ-9 at all timepoints (p < 0.001). Patients with more severe disability demonstrated different magnitudes of improvement for NDI (all p < 0.001), VAS neck (p ≤ 0.009), VAS arm (p = 0.025), and PHQ-9 (p ≤ 0.011). The effect of preoperative severity on MCID achievement was demonstrated for NDI and for PHQ-9 (p ≤ 0.007). Conclusion:Patients with severe neck disability demonstrated differences in pain, disability, physical and mental health. MCID achievement also differed by preoperative symptoms severity. Patients with more severe neck disability may be limited to the degree of improvement in quality of life but perceive them as significant changes.

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“…MCID achievement was determined through comparison of the difference in preoperative and postoperative PROM scores to a pre-established value. MCID values from Parker et al 14 were used for VAS neck (2.6), VAS arm (4.1), NDI (17.3% or 8.5), and SF-12 PCS (8.1); whereas Steinhaus et al 15 established a PROMIS PF MCID of 4.5.…”

Section: Minimum Clinically Important Differencementioning

confidence: 99%

Comorbidity Influence on Postoperative Outcomes Following Anterior Cervical Discectomy and Fusion

et al. 2021

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This study aims to detail the association between comorbidity burden and achieving minimum clinically important difference (MCID) following anterior cervical discectomy and fusion (ACDF). Methods: A prospective surgical registry was retrospectively reviewed. Patients with missing preoperative Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) were excluded. Patients were stratified by Charlson Comorbidity Index (CCI): no comorbidities = 0 point; low CCI = 1-2 points; high CCI = ≥ 3 points. Demographic and perioperative characteristics were collected and evaluated for differences. Visual analogue scale (VAS), 12-item Short Form health survey (SF-12), and PROMIS PF were collected pre-and postoperatively and assessed for differences. Differences in achievement of MCID were compared using established values: VAS neck = 2.6, VAS arm = 4.1, NDI = 8.5, SF-12 physical composite score (SF-12 PCS) = 8.1, PROMIS PF = 4.5. Results: One hundred twenty-five ACDF patients were included: 37 had no comorbidities, 64 with low CCI, and 24 with high CCI. Higher CCI groups were older, nonsmokers, diabetic, arthritic, hypertensive, and had cancer. Multilevel fusions, operative time, length of stay, and later discharge day were associated with high CCI. VAS neck differed preoperatively by group. SF-12 PCS and PROMIS PF were inversely associated with CCI groups. CCI did not impact achievement of MCID for all outcomes. A lower rate of reaching MCID was demonstrated at 3 months for SF-12 PCS. Conclusion: Regardless of comorbidity burden, patients undergoing ACDF for cervical pathology demonstrated a similar rate of achieving MCID for VAS neck, VAS arm, NDI, and PROMIS PF. Regardless of CCI score, ACDF can have a significant benefit for patients.

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Minimal Clinically Important Difference and Substantial Clinical Benefit Using PROMIS CAT in Cervical Spine Surgery

Cited by 94 publications

References 33 publications

Establishing the Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, and Substantial Clinical Benefit of the PROMIS Upper Extremity Questionnaire After Rotator Cuff Repair

Establishing the Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, and Substantial Clinical Benefit of the PROMIS Upper Extremity Questionnaire After Rotator Cuff Repair

Preoperative Neck Disability Severity Limits Extent of Postoperative Improvement Following Cervical Spine Procedures

Comorbidity Influence on Postoperative Outcomes Following Anterior Cervical Discectomy and Fusion

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