Determining validity, discriminant ability, responsiveness, and minimal clinically important differences for PROMIS in adult spinal deformity

Ibaseta, Alvaro; Rahman, Rafa; Andrade, Nicholas S.; Skolasky, Richard L.; Kebaish, Khaled M.; Sciubba, Daniel M.; Neuman, Brian J.

doi:10.3171/2020.8.spine191551

Cited by 14 publications

(10 citation statements)

References 43 publications

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“…All studies used self-reported PROMIS data, no studies on proxy-reported data were found. Of these 50 studies, 10 studies used only distribution-based methods [49,50,52,55,58,66,68,74,75,77]; five studies estimated a minimal important difference (MID) rather than minimal important change (MIC) [44,62,63,72,73]; one study averaged estimates based on cross-sectional and longitudinal anchors as well as distribution-based estimates [84]; one study estimated a MIC value that referred to more than a minimal important change [92]; and two studies intended to calculate an anchor-based MIC but reported only a distribution-based MIC because the area under the ROC curve was considered too low [82,83]. Data from these 19 studies were not extracted.…”

Section: Resultsmentioning

confidence: 99%

Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures

et al. 2021

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We define the minimal important change (MIC) as a threshold for a minimal within-person change over time above which patients perceive themselves importantly changed. There is a lot of confusion about the concept of MIC, particularly about the concepts of minimal important change and minimal detectable change, which questions the validity of published MIC values. The aims of this study were: (1) to clarify the concept of MIC and how to use it; (2) to provide practical guidance for estimating methodologically sound MIC values; and (3) to improve the applicability of PROMIS by summarizing the available evidence on plausible PROMIS MIC values. We discuss the concept of MIC and how to use it and provide practical guidance for estimating MIC values. In addition, we performed a systematic review in PubMed on MIC values of any PROMIS measure from studies using recommended approaches. A total of 50 studies estimated the MIC of a PROMIS measure, of which 19 studies used less appropriate methods. MIC values of the remaining 31 studies ranged from 0.1 to 12.7 T-score points. We recommend to use the predictive modeling method, possibly supplemented with the vignette-based method, in future MIC studies. We consider a MIC value of 2–6 T-score points for PROMIS measures reasonable to assume at this point. For surgical interventions a higher MIC value might be appropriate. We recommend more high-quality studies estimating MIC values for PROMIS.

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Section: Resultsmentioning

confidence: 99%

Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures

et al. 2021

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“…This suggests that preoperative PROMIS questionnaires may provide guidance in prioritizing symptoms for the treatment to promote greater postoperative satisfaction. Prior work found that PROMIS can discriminate between levels of disease severity and is responsive to changes in health and satisfaction after surgery for ASD 2 . By using either minimal clinically important difference values, abnormal PROMIS domains, or a combination of both, more salient preoperative factors could be identified and targeted for improvement to promote greater postoperative patient satisfaction.…”

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

“…T he National Institutes of Health developed the Patient-Reported Outcomes Measurement Information System (PROMIS), which has been validated and shown to correlate with legacy patient-reported outcome measures for many orthopedic conditions, including adult spinal deformity (ASD) and degenerative spine disease (DSD). 1,2 Studies have reported correlations between legacy patientreported outcome measures and postoperative satisfaction in spine surgery patients [3][4][5][6][7][8][9] (Supplementary Table 1, Supplemental Digital Content 1, http://links.lww.com/BRS/C179). PROMIS scores have been associated with two-week postoperative satisfaction in patients undergoing orthopedic surgery of the extremities.…”

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Abnormal Postoperative PROMIS Scores are Associated With Patient Satisfaction in Adult Spinal Deformity and Degenerative Spine Patients

Covarrubias,

Andrade,

et al. 2023

Spine

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Study Design. Retrospective review Objectives. To evaluate 1) patient satisfaction after adult spine surgery; 2) associations between number of abnormal PROMIS domain scores and postoperative satisfaction; and 3) associations between normalization of a patient’s worst preoperative PROMIS domain score and postoperative satisfaction. Summary of Background Data. Although “legacy” patient-reported outcome measures correlate with patient satisfaction after adult spine surgery, it is unclear whether PROMIS scores do. Methods. We included 1119 patients treated operatively for degenerative spine disease (DSD) or adult spinal deformity (ASD) from 2014–2019 at our tertiary hospital who completed questionnaires preoperatively and at ≥1 postoperative timepoints up to 2 years. Postoperative satisfaction was measured in ASD patients using items 21 and 22 from the SRS 22-revised questionnaire and in DSD patients using the NASS Patient Satisfaction Index. “Worst” preoperative PROMIS domain was that with the greatest clinically negative deviation from the mean. “Normalization” was a postoperative score within 1 standard deviation of the general population mean. Multivariate logistic regression identified factors associated with satisfaction. Results. Satisfaction was reported by 88% of DSD and 86% of ASD patients at initial postoperative follow-up; this proportion did not change during the first year after surgery. We observed an inverse relationship between postoperative satisfaction and number of abnormal PROMIS domains at all postoperative timepoints beyond 6 weeks. Only among ASD patients was normalization of the worst preoperative PROMIS domain associated with greater odds of satisfaction at all timepoints up to 1 year. Conclusion. The proportion of DSD and ASD patients satisfied postoperatively did not change from 6 weeks to 1 year. Normalizing the worst preoperative PROMIS domain and minimizing the number of abnormal postoperative PROMIS scores may reduce the number of dissatisfied patients. PROMIS data can guide perioperative patient management to improve satisfaction. Level of Evidence. 3

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“…ODI score decreased from 52 to 18 (65% decrease), representing a meaningful decrease in disability as the minimal clinically important difference (MCID) of the ODI instrument in ASD is estimated to be -11% [14]. PROMIS-pain interference score decreased from 67 to 39 (42% decrease), representing a meaningful decrease in pain as the MCID of the PROMIS-pain instrument in ASD is estimated to be -5 points [15]. Our objective outcome measure successfully used daily steps data obtained from the patient's smartphone shows to assess the patient's post-operative recovery course (Figure 3).…”

Section: Figure 2: Post-operative Radiographymentioning

confidence: 99%

Objective Outcomes in Lateral Osteotomy Through Anterior-to-Psoas for Severe Adult Degenerative Spine Deformity Correction

Ahmad

Yang

Basil

et al. 2021

Cureus

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Multilevel lateral interbody fusion is an acceptable surgical technique in patients with severe degenerative adult spinal deformity (ASD). The current standard-of-care in spine surgery includes the use of patient reported outcome measures (PROMs) to assess post-operative improvement. Objective activity data during the peri-operative period may provide supplementary information for patients recovering from ASD surgery. In this report, we use smartphone-based activity data as an objective outcome measure for a patient who underwent a two-stage operation for ASD corrective surgery: lateral osteotomy and lumbar interbody fusion with posterior column release.An 82-year-old male presented with intractable back pain secondary to severe thoracolumbar scoliotic deformity (Lenke 5BN). Pre-operative images demonstrated the presence of bridging osteophytes over the left lateral aspect of L2-5 disc spaces and over the apex of the lumbar curvature, with significant neuroforaminal stenosis.Surgical correction was completed in two stages: (1) left-sided lateral osteotomy using anterior-to-psoas approach (ATP) in a right lateral decubitus position, and (2) multilevel Ponte osteotomies and instrumented fusion from T10-pelvis. Post-operative radiography showed correction to scoliotic deformity and sagittal misalignment. The patient had developed seroma and wound dehiscence, which was evacuated on postoperative day 11. At 14-month follow-up, the patient reported significant improvement in pain symptoms, corroborated by patient reported outcome measures.To further quantify and assess patient recovery, smartphone-based patient activity data was collected and analyzed to serve as a proxy for the patient's functional improvement. The patient's walking steps-per-day was compared pre-and post-operatively. The patient's pre-operative baseline was 223 steps/day; the patient's activity during immediate post-operative recovery dropped to 179 steps/day; the patient returned to baseline activity levels approximately 3 months after surgery, reaching an average of 216 steps/day.In conclusion, we found that lateral osteotomy through an ATP approach is a powerful tool to restore normal spine alignment and can be successfully performed using anatomic landmarks. Additionally, smartphonebased mobility data can assess pre-operative activity level and allow for remote patient monitoring beyond routine follow-up schedule.

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Determining validity, discriminant ability, responsiveness, and minimal clinically important differences for PROMIS in adult spinal deformity

Cited by 14 publications

References 43 publications

Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures

Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures

Abnormal Postoperative PROMIS Scores are Associated With Patient Satisfaction in Adult Spinal Deformity and Degenerative Spine Patients

Objective Outcomes in Lateral Osteotomy Through Anterior-to-Psoas for Severe Adult Degenerative Spine Deformity Correction

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