Characterizing MCID and assessing the role of preoperative PROMIS scores in predicting outcomes for reverse total shoulder arthroplasty at 2-year follow-up

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) has gained more ground as a reliable and efficient means of collecting patient outcomes in different shoulder surgeries. The purpose of this study is to determine if preoperative PROMIS scores are able to predict improvement in postoperative PROMIS scores and anchor this data to determine if a patient will achieve MCID after reverse total shoulder arthroplasty (RTSA). We hypothesize that preoperative PROMIS will significantly correlate, with anchor questions allowing clinicians to predict which patients are most likely to achieve MCID after RTSA.MethodsThree PROMIS CAT forms (PROMIS Upper Extremity Physical Function CAT v2.0 (“PROMIS-UE”), PROMIS Pain Interference v1.1 (“PROMIS-PI”), and PROMIS Depression v1.0 (“PROMIS-D”)) were provided to all patients scheduled to undergo RTSA by board-certified shoulder and elbow surgeons at 1 institution. Demographic data was collected, including age, median household income, zip code, body mass index, sex, smoking status, and race. All patients enrolled in the study were contacted and asked the same 3 anchor questions pertaining to the 3 PROMIS CAT forms above.ResultsA total of 71 patients (52.1% male) were included in our cohort with an average age of 67.8 years (standard deviation, 8.4). Mean follow-up time point was 21.4 months (standard deviation, 9.9) after surgery. Neither preoperative PROMIS-UE, nor preoperative PROMIS-PI showed any significant predictive ability to achieve their respective domain MCIDs (AUC: 0.564 and 0.631, respectively). PROMIS-UE and PROMIS-PI improved to a significant degree at an average 21.4 months postoperatively from 29.2 ± 5.8 and 63.8 ± 4.8 to 39.8.9 ± 8.9 and 50.0 ± 9.7, respectively. Improvements in PRMOIS-D scores were insignificant at average 21.4 months (Baseline: 49.8 ± 8.0 vs. 44.5 ± 9.4 at final follow-up). Using anchor-based analysis to determine MCID, we found the following MCID values for PROMIS-UE, PROMIS-PI, and PROMIS-D: 7.0, -6.6, and -3.9, respectively. ROC analysis revealed MCID values for PROMIS-UE, PI, and D as 7.0, -6.6, and -3.9 respectively (AUC: 0.743, 0.805, 0.601). SCB values for PROMIS-UE, PI, and D were identified as 8.4, -12.1, and -4.0, respectively (AUC: 0.883, 0.932, 0.652).ConclusionsPROMIS-UE and PROMIS-PI questionnaires can adequately assess the symptoms and outcomes of RTSA patients out to two years postoperatively. Preoperative baseline PROMIS-UE, PROMIS-PI, and PROMIS-D scores cannot adequately predict achievement of MCID in patients indicated for primary RTSA when using anchor-based methods at final follow-up, and should not be used to counsel patients on surgery or guide postoperative treatment.Level of EvidenceLevel II; Retrospective Cohort Study     

The Impact of Total Hip Arthroplasty Surgical Approach on Patient-Reported Outcomes Measurement Information System Computer Adaptive Tests of Physical Function and Pain Interference

BackgroundThe present study examines Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Test (CAT) scores for domains of physical function (PF) and pain interference (PI) in patients undergoing elective THA from either a direct anterior or posterior surgical approach.MethodsA total of 1358 patients who underwent THA at our institution from 1/1/2015 to 12/1/2018 were identified. Visual analog scale (VAS) pain scores, PROMIS CAT PF and PI data were collected at the last preoperative visit as well as 6 weeks, 6 months, and 1-2 years postoperatively. Literature-derived minimum clinically important difference (MCID) for PROMIS CAT PF metric with regard to THA was used for data comparison.ResultsFour hundred nine patients were included in the final analysis. Fifty-one percent underwent a posterior approach, and 49% underwent a direct anterior approach. Both approaches led to a significant improvement in PROMIS CAT PF and PI scores. Patients undergoing a direct anterior approach had significantly higher preoperative and postoperative PROMIS CAT PF scores as well as significantly lower preoperative PROMIS CAT PI scores. Each approach yielded similar interval improvements of PROMIS CAT PF and PI. One hundred three direct anterior approach THA patients (51%) and 119 posterior approach THA patients (57.5%) achieved PROMIS PF MCID at 1- to 2-year follow-up.ConclusionNeither the direct anterior nor posterior THA surgical approach conferred an advantage to postoperative improvements of PROMIS CAT PF and PI scores. Adult reconstructive surgeons should continue to execute the direct anterior or posterior THA surgical approaches based upon personal preference. Despite surgeon confidence in THA, the potential for further innovation exists given the number of THA patients who failed to achieve PROMIS PF MCID.     

Role of preoperative PROMIS scores in predicting postoperative outcomes and likelihood of achieving MCID following reverse shoulder arthroplasty

BackgroundThe patient-reported outcomes measurement information system (PROMIS) has emerged as an efficient and valid outcome measure in various shoulder surgeries. The purpose of this study was to investigate the influence of preoperative PROMIS scores in predicting postoperative PROMIS scores and the likelihood of achieving a minimal clinically important difference (MCID) following primary reverse total shoulder arthroplasty for cuff tear arthropathy. We hypothesize that preoperative PROMIS scores will influence both postoperative PROMIS scores and the probability of achieving MCID.Methods73 patients undergoing reverse shoulder arthroplasty by a board-certified shoulder and elbow surgeon were given three PROMIS CAT forms: PROMIS Upper Extremity Physical Function CAT v2.0 (“PROMIS-UE”), PROMIS Pain Interference v1.1 (“PROMIS-PI”), and PROMIS Depression v1.0 (“PROMIS-D”).). PROMIS CAT domain t scores were assessed for significance between both time points using a Paired Samples t test. Minimal clinically important difference (MCID) was calculated using the distribution method and each PROMIS domain was subsequently assessed for its discriminatory ability in predicting postoperative improvement equal to or greater than the MCID through receiver operating characteristic (ROC) curve analysis.ResultsOur cohort consisted of 73 patients (49.3% male) and an average age of 69.7 years (standard deviation, 11.9). Mean follow-up time point was 9.6 months (standard deviation, 5.0) after surgery. Preoperative PROMIS-UE, PROMIS-PI, and PROMIS-D were 29.5 ± 6.2, 63.3 ± 5.4, and 50.1 ± 9.2, respectively. Each domain significantly improved at 10-months, on average, to 40.9 ± 7.8, 51.4 ± 8.5, 42.6 ± 8.1, respectively. Following the distribution-based method for MCID calculation, we found the following MCID values for PROMIS-UE, PROMIS-PI, and PROMIS-D: 3.1, 2.7, and 4.6, respectively. ROC analysis revealed strong predictive ability for PROMIS-UE (AUC = 0.717, p < 0.05), moderative predictive ability for PROMIS-PI (AUC = 0.634, p < 0.05), and excellent predictive ability for PROMIS-D (AUC = 0.864, p < 0.05). Specifically, preoperative cutoff values of <26.0, >70.0, and >52.5 for PROMIS-UE, PROMIS-PI, and PROMIS-D are especially predictive of achieving MCID.ConclusionsPreoperative baseline scores can serve as strong predictors of success in patients undergoing primary reverse shoulder arthroplasty and can be used to both counsel patients on surgery and to tailor postoperative protocols.Level of evidenceLevel II.     

The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures

Background

The Patient-rated Wrist Evaluation (PRWE) is a commonly used instrument in upper extremity surgery and in research. However, to recognize a treatment effect expressed as a change in PRWE, it is important to be aware of the minimum clinically important difference (MCID) and the minimum detectable change (MDC). The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change, while the MDC is defined as the smallest amount of change that can be detected by an outcome measure. A numerical change in score that is less than the MCID, even when statistically significant, does not represent a true clinically relevant change. To our knowledge, the MCID and MDC of the PRWE have not been determined in patients with distal radius fractures.

Questions/Purposes

We asked: (1) What is the MCID of the PRWE score for patients with distal radius fractures? (2) What is the MDC of the PRWE?

Methods

Our prospective cohort study included 102 patients with a distal radius fracture and a median age of 59 years (interquartile range [IQR], 48–66 years). All patients completed the PRWE questionnaire during each of two separate visits. At the second visit, patients were asked to indicate the degree of clinical change they appreciated since the previous visit. Accordingly, patients were categorized in two groups: (1) minimally improved or (2) no change. The groups were used to anchor the changes observed in the PRWE score to patients’ perspectives of what was clinically important. We determined the MCID using an anchor-based receiver operator characteristic method. In this context, the change in the PRWE score was considered a diagnostic test, and the anchor (minimally improved or no change as noted by the patients from visit to visit) was the gold standard. The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID.

Results

In our study, the MCID of the PRWE was 11.5 points. The area under the curve was 0.54 (95% CI, 0.37–0.70) for the pain subscale and 0.71 (95% CI, 0.57−0.85) for the function subscale. We determined the MDC to be 11.0 points.

Conclusions

We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID.

Clinical Relevance

We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinically relevant difference when evaluating the effects of treatments and when performing sample-size calculations on studies of distal radius fractures.     

Correlation of mJOA,PROMIS physical function,and patient satisfaction in patients with cervical myelopathy: an analysis of the Michigan Spine Surgery Improvement Collaborative (MSSIC) database

BACKGROUND CONTEXTPatient-reported outcomes (PROs) are increasingly utilized to evaluate the efficacy and value of spinal procedures. Among patients with cervical myelopathy, the modified Japanese Orthopaedic Association (mJOA) remains the standard instrument, with Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and patient satisfaction also frequently assessed. These outcomes have not all been directly compared using a large spine registry at 2 years follow-up for cervical myelopathic patients undergoing surgery.PURPOSETo determine the correlation and association of PROMIS PF, mJOA, and patient satisfaction outcomes in patients undergoing surgery for cervical myelopathy.STUDY DESIGN/SETTINGRetrospective review of a multicenter spine registry database.PATIENT SAMPLEAdult patients with cervical myelopathy who underwent cervical spine surgery between 2/26/2018 and 4/17/2021.OUTCOME MEASURESPROMIS PF, mJOA, and North American Spine Society (NASS) patient satisfaction index.METHODSThe MSSIC database was accessed to gather pre- and postoperative outcome data on patients with cervical myelopathy. Spearman's correlation coefficients relating mJOA and PROMIS PF were quantified up to 2 years postoperatively. The correlations between patient satisfaction with mJOA and PROMIS were determined. Kappa statistics were used to evaluate for agreement between those reaching the minimum clinically important difference (MCID) for mJOA and PROMIS PF. Odds ratios were calculated to determine the association between patient satisfaction and those reaching MCID for mJOA and PROMIS PF. Support for MSSIC is provided by BCBSM and Blue Care Network as part of the BCBSM Value Partnerships program.RESULTSData from 2,023 patients were included. Moderate to strong correlations were found between mJOA and PROMIS PF at all time points (p<.001). These outcomes had fair agreement at all postoperative time points when comparing those who reached MCID. Satisfaction was strongly related to changes from baseline for both mJOA and PROMIS PF at all time points (p<.001). Odds ratios associating satisfaction with PROMIS PF MCID were higher at all time points compared with mJOA, although the differences were not significant.CONCLUSIONSPROMIS PF has a strong positive correlation with mJOA up to 2 years postoperatively in patients undergoing surgery for cervical myelopathy, with similar odds of achieving MCID with both instruments. Patient satisfaction is predicted similarly by these outcome measures by 2 years postoperatively. These results affirm the validity of PROMIS PF in the cervical myelopathic population. Given its generalizability and ease of use, PROMIS PF may be a more practical outcome measure for clinical use compared with mJOA.     

Clinically meaningful improvement in disabilities of arm,shoulder, and hand (DASH) following cervical spine surgery

BACKGROUND CONTEXTPatients with cervical spine disease suffer from upper limb disability. At present, no clinical benchmarks exist for clinically meaningful change in the upper limb function following cervical spine surgery.PURPOSEPrimary: to establish clinically meaningful metrics; the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper limb functional improvement in patients following cervical spine surgery. Secondary: to identify the prognostic factors of MCID and SCB of upper limb function following cervical spine surgery.STUDY DESIGNRetrospective cohort study.PATIENT SAMPLEAdult patients ≥18 years of age who underwent cervical spine surgery from 2012 to 2016.OUTCOME MEASURESPatient-reported outcomes: Neck disability index (NDI) and Disabilities of Arm, Shoulder, and Hand (DASH).METHODSMCID was defined as minimal improvement and SCB as substantial improvement in the DASH score at last follow-up. The anchor-based methods (ROC analyses) defined optimal MCID and SCB thresholds with area under curve (AUC) in discriminating improved vs. non-improved patients. The MCID was also calculated by distribution-based methods: half standard-deviation (0.5-SD) and standard error of the mean (SEM) method. A multivariable logistic regression evaluated the impact of baseline factors in achieving the MCID and SCB in DASH following cervical spine surgery.RESULTSBetween 2012 and 2016, 1,046 patients with average age of 57±11.3 years, 53% males, underwent cervical spine surgery. Using the ROC analysis, the threshold for MCID was –8 points with AUC of 0.73 (95% CI: 0.67–0.79) and the SCB was –18 points with AUC of 0.88 (95% confidence interval [CI]: 0.85–0.91). The MCID was –11 points by 0.5–SD and –12 points by SEM-method. On multivariable analysis, patients with myelopathy had lower odds of achieving MCID and SCB, whereas older patients and those with ≥6 months duration of symptoms had lower odds of achieving DASH MCID and SCB respectively.CONCLUSIONsIn patients undergoing cervical spine surgery, MCID of –8 points and SCB of –18 points in DASH improvement may be considered clinically significant. These metrics may enable evaluation of minimal and substantial improvement in the upper extremity function following cervical spine surgery.     

Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma

BackgroundThe Toronto Extremity Salvage Score (TESS) is the most widely used patient-reported outcome measure for orthopaedic oncology patients. However, minimal clinically important differences (MCIDs) in the TESS have not been analyzed. The aim of this study was to define the MCIDs of TESS in patients with lower extremity sarcoma.MethodsA total of 85 patients were investigated to calculate the MCIDs for TESS. Three different methods were used: 1) distribution-based methods based on one-half of the standard deviation and standard error of measurement (SEM) at the baseline, 2) anchor-based and receiver operating characteristic (ROC) analysis, and 3) anchor-based using Akaike's Information Criterion (AIC) analysis.ResultsThe MCIDs at 6 months were 4.9–7.8 by distribution-based methods and 4.3–4.4 by anchor-based methods. The MCIDs at 12 months were 4.0–6.9 by distribution-based methods and 10.6–11.6 by anchor-based methods.ConclusionsWe calculated MCID values for the TESS based on distribution- and anchor-based approaches. Our results seem reasonable since MCIDs calculated by the different approaches had similar values. This knowledge will enable clinicians to identify meaningful functional improvements in sarcoma patients.     

Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales

BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain.     

Development of prediction models for clinically meaningful improvement in PROMIS scores after lumbar decompression

BACKGROUNDThe ability to preoperatively predict which patients will achieve a minimal clinically important difference (MCID) after lumbar spine decompression surgery can help determine the appropriateness and timing of surgery. Patient-Reported Outcome Measurement Information System (PROMIS) scores are an increasingly popular outcome instrument.PURPOSEThe purpose of this study was to develop algorithms predictive of achieving MCID after primary lumbar decompression surgery.PATIENT SAMPLEThis was a retrospective study at two academic medical centers and three community medical centers including adult patients 18 years or older undergoing one or two level posterior decompression for lumbar disc herniation or lumbar spinal stenosis between January 1, 2016 and April 1, 2019.OUTCOME MEASURESThe primary outcome, MCID, was defined using distribution-based methods as one half the standard deviation of postoperative patient-reported outcomes (PROMIS physical function, pain interference, pain intensity).METHODSFive machine learning algorithms were developed to predict MCID on these surveys and assessed by discrimination, calibration, Brier score, and decision curve analysis. The final model was incorporated into an open access digital application.RESULTSOverall, 906 patients completed at least one PROMs survey in the 90 days before surgery and at least one PROMs survey in the year after surgery. Attainment of MCID during the study period by PROMIS instrument was 74.3% for physical function, 75.8% for pain interference, and 79.2% for pain intensity. Factors identified for preoperative prediction of MCID attainment on these outcomes included preoperative PROs, percent unemployment in neighborhood of residence, comorbidities, body mass index, private insurance, preoperative opioid use, surgery for disc herniation, and federal poverty level in neighborhood of residence. The discrimination (c-statistic) of the final algorithms for these outcomes was 0.79 for physical function, 0.74 for pain interference, and 0.69 for pain intensity with good calibration. The open access digital application for these algorithms can be found here: https://sorg-apps.shinyapps.io/promis_pld_mcid/CONCLUSIONLower preoperative PROMIS scores, fewer comorbidities, and certain sociodemographic factors increase the likelihood of achieving MCID for PROMIS after lumbar spine decompression.     

Determination of minimum clinically important difference (MCID) in pain,disability, and quality of life after revision fusion for symptomatic pseudoarthrosis

Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.     

The minimum clinically important difference for the Japanese version of the new Knee Society Score (2011KSS) after total knee arthroplasty

BackgroundThe new Knee Society Score (2011KSS) has been used to evaluate post-operative outcomes after total knee arthroplasty (TKA). However, there is no minimum clinically important difference (MCID) for 2011KSS. The purpose of this study is to define MCID of 2011KSS after TKA.MethodsPatients who underwent primary TKA for primary knee osteoarthritis between April 2012 and December 2016 were included in the study. The Japanese version of 2011KSS and original Knee Society Score (OKSS) were recorded preoperatively and at one-year postoperatively. With improvement in pain score of OKSS as an anchor, an anchor-based approach was used to identify the MCID of 2011KSS. The improvement in pain of OKSS was classified into 5 categories. The MCID was determined using a linear regression analysis of delta 2011KSS against improvement in the category of pain in OKSS. The MCID for 2011KSS expectation was not calculated because the items of pre- and post-operative questionnaires were different.ResultsFive hundred and twenty-two cases were enrolled (age: 74.8 ± 7.3 years, female: 80.0%). After 1-year follow-up, 344 TKAs were finally included (age: 74.6 ± 7.1 years, female: 77.9%). Linear regression analyses showed that MCID for 2011KSS was 1.9 (95% confidential interval (CI): 1.3–2.5) in symptom, 2.2 (95%CI: 1.4–2.9) in satisfaction, and 4.1 (95%CI: 2.5–5.7) in functional activities.ConclusionsMCID for 2011KSS was successfully calculated. These MCID values make the 2011KSS a more efficient tool for evaluating the physical activities of the populations of patients undergoing TKA. These MCID values can also be used to calculate sample size to evaluate the power of a study in designing clinical studies.     

Understanding the minimum clinically important difference: a review of concepts and methods.

BACKGROUND CONTEXT: The effectiveness of spinal surgery as a treatment option is currently evaluated through the assessment of patient-reported outcomes (PROs). The minimum clinically important difference (MCID) represents the smallest improvement considered worthwhile by a patient. The concept of an MCID is offered as the new standard for determining effectiveness of a given treatment and describing patient satisfaction in reference to that treatment. PURPOSE: Our goal is to review the various definitions of MCID and the methods available to determine MCID. STUDY DESIGN: The primary means of determining the MCID for a specific treatment are divided into anchor-based and distribution-based methods. Each method is further subdivided and examined in detail. METHODS: The overall limitations of the MCID concept are first identified. The basic assumptions, statistical biases, and shortcomings of each method are examined in detail. RESULTS: Each method of determining the MCID has specific shortcomings. Three general limitations in the accurate determination of an MCID have been identified: the multiplicity of MCID determinations, the loss of the patient's perspective, and the relationship between pretreatment baseline and posttreatment change scores. CONCLUSIONS: An ideal means of determining the MCID for a given intervention is yet to be determined. It is possible to develop a useful method provided that the assumptions and methodology are initially declared. Our efforts toward the establishment of a MCID will rely on the establishment of specific external criteria based on the symptoms of the patient and treatment intervention being evaluated.     

Early Experience and Results Using Patient-Reported Outcomes Measurement Information System Scores in Primary Total Hip and Knee Arthroplasty

BackgroundOur study determined if preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores could predict achieving minimum clinically important differences (MCIDs) in postoperative PROMIS scores after primary total hip and knee arthroplasty.MethodsNinety-three patients were administered the PROMIS Depression, Pain Interference, and Physical Function domains at their preoperative appointment and 6-week follow-up visit. MCIDs were drawn from existing literature for the PROMIS domains.ResultsThe MCID was achieved in 74% of patients for Pain Interference, 34% for Physical Function, and 24% for Depression. Our model could predict with 90% specificity which patients would meet MCID if their preop PROMIS Pain score was above 38, Physical Function score less than 19, or Depression score above 22.ConclusionPreoperative PROMIS Pain Interference, Physical Function, and Depression scores can predict achieving MCID in postoperative PROMIS scores.     

The influence of gender on postoperative PROMIS physical function outcomes following minimally invasive transforaminal lumbar interbody fusion

PurposeOur aim is to examine the gender performance of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF) scores among patients undergoing minimally invasive transforaminal lumbar fusion (MIS TLIF).MethodsA prospectively collected surgical dataset was retrospectively assessed for eligible patients from March 2015–June 2019. We included patients if they underwent primary MIS TLIF procedures on one or two vertebral levels. We collected baseline demographics, perioperative characteristics, and PROMIS-PF scores for each subject at pre and postoperative timepoints (e.g., 6-weeks, 3-months, 6-months, and 1-year). Chi-squared analyses were utilized to assess categorical variables and a Student’s t-tests analyzed continuous variables. A linear regression was used to analyze PROMIS-PF scores from baseline through all postoperative time points. Finally, we evaluated the PROMIS PF achievement of minimal clinically important difference (MCID) among gender.Results192 patients were included: 77 were females and 115 were males. No significant differences were observed among gender subgroups for PROMIS-PF scores at pre- or postoperative evaluations. Compared to males, females experienced significantly greater postoperative improvement with PROMIS-PF scores at the 3-month assessments, though no significant gender differences were observed during later follow-up evaluations at 6-months or one year. Females were observed to have significant PROMIS-PF score improvement from their preoperative evaluation to each postoperative score. Males were assessed to have statistically significant postoperative (e.g., at 3-months, 6-months, and 1-year) PROMIS-PF score improvement from their preoperative PROMIS-PF scores. There were no significant differences among gender in achieving MCID at any postoperative time interval.ConclusionAmong gender, we observed no statistically significant difference in PROMIS-PF scores during the pre- or postoperative evaluations. Additionally, with no difference in the rate of achieving PROMIS-PF MCID postoperatively, this study established that both genders should experience similar functional outcomes following MIS TLIF.     

Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit

Background

The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However, the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context, the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments, patient satisfaction and cost-effectiveness.

Methods

Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI, PCS, MCS and VAS) were collected preoperatively, and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS, HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen.

Results

On average, all patients presented with a statistically significant improvement (p?<?0.001) postoperatively for NDI (27.42 to 19.42), PCS (33.02 to 42.03), MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23–16.59 for PCS, 0.11–16.27 for MCS and 2.72–12.08 for NDI. When compared to the VAS and HTI anchors, the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation.

Conclusion

The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI), and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS, 5.12 for MCS and 2.41 for NDI.     

Outcomes Vary Significantly Using a Tiered Approach to Define Success After Total Knee Arthroplasty

BackgroundPatient-reported outcome measures (PROM) allow assessment of clinical outcomes following primary total knee arthroplasty (TKA). The purpose of this study is to use progressively more stringent definitions of success to examine clinical outcomes of primary TKA at 1 year postoperatively and to determine which demographic variables were associated with achieving clinical success.MethodsThe American Joint Replacement Registry was queried from 2012 to 2020 for primary TKA. Patients who completed the following PROMs preoperatively and 1 year postoperatively were included: Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and KOOS for Joint Replacement (KOOS JR). Mean PROM scores were determined for each visit and between-visit changes were evaluated using paired t-tests. Rates of achievement of minimal clinically important difference (MCID) by distribution-based and anchor-based criteria, Patient Acceptable Symptom State, and substantial clinical benefit were calculated. Logistic regression was used to evaluate the association between demographic variables and odds of clinical success.ResultsIn total, 12,341 TKAs were included. Mean improvement in PROM scores were as follows: KOOS JR, 29; WOMAC-Pain, 33; and WOMAC-Function, 31 (P < .0001 for all). Rates of achievement of each metric were the following: distribution-based MCID, 84%-87%; anchor-based MCID, 46%-79%; Patient Acceptable Symptom State, 54%-82%; and substantial clinical benefit, 68%-81%. Patient age and gender were the most influential demographic factors on achievement of clinical success.ConclusionClinical outcomes at 1 year following TKA vary significantly when using a tiered approach to define success. A tiered approach to interpretation of PROMs should be considered for future research and clinical assessment.     

Workers compensation patients experiencing depression report meaningful improvement in mental health scores after anterior cervical discectomy and fusion

BackgroundMental health has been demonstrated to affect postoperative outcomes. No prior literature has reported the relationship between preoperative mental health on outcomes following anterior cervical discectomy and fusion (ACDF) in the Workers Compensation (WC) population.MethodsWC claimants who underwent primary ACDF were identified from a single-surgeon retrospective database. Patients were separated by SF-12 MCS score into Depressed (<45.6) or Not Depressed (ND) (≥45.6) cohorts. Patient-reported Outcome Measurement Information System Physical Function (PROMIS PF), SF-12 Physical Component Score (SF-12 PCS), SF-12 MCS, visual analog scale (VAS) neck/arm pain, and Neck Disability Index (NDI) were collected and compared within and between groups. Minimum clinically important difference (MCID) achievement rates were compared between groups.ResultsDepressed patients had greater length of stay (p = 0.007) and postoperative narcotic consumption (p = 0.026). Depressed patients improved at 12-week to 2-year PROMIS PF, 6-month SF-12 PCS, 6-week to 6-month SF-12 MCS, 6-week to 6-month and 2-year VAS neck, all VAS arm, and 6-month NDI (p ≤ 0.045, all). ND patients improved at 12-week to 1-year PROMIS PF, 6-month to 2-year SF-12 PCS, 12-week to 1-year VAS neck, 6-week to 1-year VAS arm, and 12-week to 1-year NDI (p ≤ 0.044, all). Between groups, ND patients reported superior PROMIS PF, SF-12 MCS, VAS neck, VAS arm, and NDI scores at two or more periods (p ≤ 0.045, all). MCID achievement rate regarding SF-12 MCS was greater in the Depressed cohort at all postoperative points up to 1 year (p ≤ 0.020, all).ConclusionDepressed patients tended to have a greater length of stay and postoperative narcotic consumption immediately after surgery. Not depressed patients reported more favorable physical and mental function, pain, and disability scores preoperatively and postoperatively. Depressed patients reported greater MCID achievement in mental function following surgery. Depressed patients with WC have a greater likelihood of reporting tangible improvement in mental health scores following ACDF.     

Preoperative patient activation predicts minimum clinically important difference for PROMIS pain and physical function in patients undergoing elective spine surgery

BACKGROUND CONTEXTPatient activation is a patient's willingness to take independent actions to manage their own health care.PURPOSEThe goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery.STUDY DESIGN/SETTINGRetrospective review.PATIENT SAMPLEA single-institution, academic database of patients undergoing elective spine surgery.OUTCOME MEASUREMCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety.METHODSWe retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function.RESULTSOf the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08–6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20–8.57), and stage 4 (aOR:5.56, 95% CI:2.20–14.01) were more likely to achieve MCID.CONCLUSIONPatients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes.     

Evaluation of transforaminal epidural steroid injections for discogenic axial lumbosacral back pain utilizing PROMIS as an outcome measure

Background contextDiscogenic lumbosacral back pain continues to present a challenging clinical entity with limited, controversial therapeutic options. No study to date has evaluated the efficacy of fluoroscopically guided transforaminal epidural steroid injections (TFESI) in a homogenous patient population with axial lumbosacral back pain from discogenic pathology utilizing strict, explicitly clinical and radiographic criteria. Additionally, there is a paucity of published data utilizing Patient Reported Outcome Measurement Information System (PROMIS) scores as an outcome measure for interventional spine procedures.PurposeEvaluate the therapeutic effect of TFESIs in a specific subset of patients with discogenic axial lumbosacral back pain. Investigate PROMIS as an outcome measure for interventional spine procedures targeting focal degenerative spinal pathology.Study design/settingRetrospective review of patients presenting to a multidisciplinary, tertiary academic spine center.Patient sampleThree thousand eight hundred eighty-one patients were screened for inclusion. A total of 26 patients with discogenic axial low back, based on strict clinical and radiographic criteria, underwent TFESIs. All patients had axial low back pain without radicular pain, ≥3 clinical features of discogenic pain, corroborative radiographic features of active discogenic pathology on lumbar spine magnetic resonance imaging without confounding spinal pathology.Outcome measuresPROMIS Pain Interference (PI) v1.1, PROMIS Physical Function (PF) v1.2/v2.0, and PROMIS Depression (D) v1.0 outcome scores were collected at baseline and postprocedure follow-up.MethodsQuery of an institutional, patient reported outcome database and subsequent retrospective review of electronic medical records was performed. Statistical analysis comparing baseline and postprocedural PROMIS outcome scores and correlation between these instruments was performed. Additionally, an exploratory investigation of minimal clinically important difference achievement rates was performed.ResultsAnalysis determined a statistically significant improvement in PROMIS PI (p=.017, 95% CI=?8.02 to ?1.82) and PROMIS PF (p=.003, 95% CI=0.91–8.72) scores after treatment with TFESIs. At post treatment time points, TFESI had medium effect size on pain (d=0.55) and function (d=0.59). Change in PROMIS D scores (p=.488, 95% CI ?1.74–3.54; d=.08) did not demonstrate statistical significance. Pearson correlation demonstrated a moderate negative correlation (r=?0.544, p=.004) between PROMIS PF with PROMIS PI. Correlation between PROMIS PF (r=?0.239, p=.24) and PROMIS PI (r=0.198, p=.33) with PROMIS D was not significant. Fourteen (53.8%) and 9 (34.6%) subjects achieved minimum clinically important difference (MCID) for PROMIS PI and PROMIS PF, respectively. Nine subjects (34.6%) achieved MCID for PROMIS D despite not otherwise reaching statistical significance otherwise.ConclusionsUtilizing PROMIS as an outcome measure, discogenic axial lumbosacral back pain patients appear to benefit from TFESI in terms of pain and physical function. This study contributes to the growing body of literature utilizing PROMIS scores in patients with clinical sequelae of degenerative spinal pathology; however, prospective studies are needed.