Anchor Question Research Articles

Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients?

BACKGROUND CONTEXTHealth-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant. PURPOSETo calculate MCID and minimum detectable change (MDC) values of total scores of the Core Outcome Measures Index (COMI), Oswestry Disability Index (ODI), Physical Component Summary (PCS), Mental Component Summary (MCS) of the Short Form 36 (SF-36), and Scoliosis Research Society 22R (SRS-22R) in surgically and nonsurgically treated ASD patients who have completed an anchor question at pretreatment and 1-year follow-up. STUDY DESIGN/SETTINGProspective cohort. PATIENT SAMPLESurgical and nonsurgical patients from a multicenter ASD database. OUTCOME MEASURESSelf-reported HRQOL measures (COMI, ODI, SF-36, SRS-22R, and anchor question). METHODSA total of 185 surgical and 86 nonsurgical patients from a multicenter ASD database who completed pretreatment and 1-year follow-up HRQOL scales and the anchor question at the first year follow-up were included. The anchor question was used to determine MCID for each HRQOL measure. MCIDs were calculated by an anchor-based method using latent class analysis (LCA) and MDCs by a distribution-based method. RESULTSAll differences between means of baseline and first year postoperative total score measures for all scales demonstrated statistically significant improvements in the overall population as well as the surgically treated patients but not in the nonsurgical group. The calculated MDC and MCID values of HRQOL parameters in the entire study population were 1.34 and 2.62 for COMI, 10.65 and 14.31 for ODI, 6.09 and 7.33 for SF-36 PCS, 6.14 and 4.37 for SF-36 MCS, and 0.42 and 0.71 for SRS-22R. The calculated MCID values for surgical and non-surgical treatment groups were 2.76 versus 1.20 for COMI, 14.96 versus 2.45 for ODI, 7.83 versus 2.15 for SF-36 PCS, 5.14 versus 2.03 for SF-36 MCS, and 0.94 versus 0.11 for SRS-22R; the MDC values for surgical and nonsurgical treatment groups were 1.22 versus 1.51 for COMI, 10.27 versus 9.45 for ODI, 5.16 versus 6.77 for SF-36 PCS, 6.05 versus 5.67 for SF-36 MCS, and 0.38 versus 0.43 for SRS-22R. CONCLUSIONSThis study has demonstrated that MCID calculations for the HRQOL scales in ASD using LCA yield values comparable to other studies that had used different methodologies. The most important finding was the significantly different MCIDs for COMI, ODI, SF-36 PCS and SRS-22 in the surgically and nonsurgically treated cohorts. This finding suggests that a universal MCID value, inherent to a specific HRQOL for an entire cohort of ASD may not exist. Use of different MCIDs for surgical and nonsurgical patients may be warranted.

Performance of the Michigan Hand Outcomes Questionnaire in hand osteoarthritis

To investigate the performance of the Michigan Hand Outcomes Questionnaire (MHQ) in hand osteoarthritis (OA) by evaluating truth, discrimination and feasibility. Symptomatic hand OA patients from the Hand Osteoarthritis in Secondary Care (HOSTAS) cohort completed questionnaires (demographics, MHQ, Australian/Canadian Hand Osteoarthritis Index [AUSCAN], Functional Index for Hand Osteoarthritis [FIHOA] and visual analogue scale [VAS] pain) at baseline (n=383), 1- and 2-year follow-up (n=312, n=293). Anchor questions at follow-up assessed whether pain/function levels were (un)acceptable and had changed compared to baseline. Correlations between MHQ and other pain/function questionnaires were calculated. Validity of unique MHQ domains (work performance, aesthetics, satisfaction), discrimination across disease stages, and responsiveness were assessed by categorizing patients by external anchors (employment, joint deformities, erosions, and anchor questions). Between-group differences were assessed with linear regression, probability plots and comparison of medians. MHQ pain and function subscales correlated moderately-to-good with other instruments (rs 0.63-0.81). Work performance scores were worse in patients with reduced working capacity than in employed patients. Aesthetics scores were worse in patients with more deformities. Patients with unacceptable complaints had worse satisfaction scores. All pain/function instruments discriminated between patients with acceptable vs unacceptable pain/function, while only MHQ activities of daily living (ADL), FIHOA, and MHQ aesthetics could discriminate between erosive and non-erosive disease. MHQ and AUSCAN were most responsive. MHQ has several unique aspects and advantages justifying its use in hand OA, including the unique assessment of work performance, aesthetics, and satisfaction. However, MHQ, AUSCAN and FIHOA appear to measure different aspects of pain and function.

Minimal clinically important difference for the 22‐item Sinonasal Outcome Test in medically managed patients with chronic rhinosinusitis

To determine the minimal clinically important difference (MCID) of the 22-item Sinonasal Outcome Test (SNOT-22) in individuals undergoing medical management for their chronic rhinosinusitis (CRS). Prospective observational study. Academic, tertiary care centre. A total of 247 adults undergoing medical management for CRS. At enrolment, participants completed a SNOT-22. At a subsequent follow-up visit, 2-12months after enrolment, participants also completed a SNOT-22. At follow-up, participants also rated the change in their sinus symptoms and general health as "Much worse," "A little worse," "About the same," "A little better" or "Much better" compared with enrolment; these two questions were used as sinus symptom and general health anchor questions, respectively. The SNOT-22 MCID was calculated using distribution-based, anchor-based and receiver operating characteristic (ROC) curve-based methods. Using the distribution-based method, the SNOT-22 MCID was 11.6. Using the sinus symptom anchor question, the SNOT-22 MCID was 10.5; applying the ROC method to the sinus symptom anchor yielded an MCID of 12.5. In comparison, using the general health anchor question, the SNOT-22 MCID was 8.3; applying the ROC method to the sinus symptom anchor yielded an MCID of 17.5. In all cases, the calculated MCID had a sensitivity of approximately 50-60% and specificity of approximately 80-90%. Based on our results, we propose a SNOT-22 MCID of 12 in medically managed patients with CRS. The MCID, while specific, was not sensitive for identifying patients with CRS experiencing a noticeable improvement in sinus symptoms or general health.

Preoperative Outcome Scores are Predictive of Achieving the Minimal Clinically Important Difference After Treatment of Focal Cartilage Defects of the Knee with Osteochondral Grafts

Objectives:Osteochondral autograft transfer (OAT) and fresh osteochondral allograft transplantation (OCA) are popular cartilage restoration techniques that involve the single-stage implantation of viable, mature hyaline cartilage into focal chondral defects of the knee. Both techniques have demonstrated good results, as defined by statistically significant post-surgical improvements in patient-reported outcome measures. Recently, there has been greater focus on what represents a clinically relevant change in outcomes reporting, and commonly applied metrics for measuring clinical significance, such as the minimal clinically important difference (MCID) and substantial clinical benefit (SCB), have become the standard. Although a previous study defined a MCID in patients treated for articular cartilage defects in the knee (Greco et al, AJSM 2010), these patients were treated with various cartilage restoration procedures (e.g., debridement, microfracture, autologous chondrocyte implantation), and none were treated with OAT/OCA. Therefore, the purpose of this study was to define the MCID and SCB thresholds after OAT/OCA for the International Knee Documentation Committee subjective knee form (IKDC) and Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADL) and to determine clinical and demographic patient factors predictive for achieving the MCID and SCB after OAT/OCA.Methods:A prospective institutional cartilage registry was reviewed to identify patients who underwent OAT/OCA. The IKDC and KOS-ADL were administered preoperatively and at a minimum of 2 years postoperatively. The MCID and SCB of these outcome scores were calculated using anchor-based methods. Receiver operative characteristic (ROC) analysis was used to determine the SCB using an anchor question, with the area under the curve (AUC) used to evaluate predictive ability. Multivariate analysis was performed to identify patient factors associated with achieving the MCID and SCB.Results:In total, 173 knees in 173 patients (mean age, 33.0 ± 13.2 years; 37.0% female) were identified. Patient demographics and clinical variables are listed in Table 1. Using the anchor-based method, the MCID for the IKDC and KOS-ADL were 17 ± 3.9 and 10 ± 3.7, respectively. Using the ROC method, the SCB for the IKDC and KOS-ADL were 32 (AUC 0.86) and 10 (AUC 0.76), respectively. Univariate analysis demonstrated no association between procedure (OAT or OCA) or lesion location and likelihood of achieving the MCID/SCB. In multivariate analysis, lower preoperative IKDC scores and higher preoperative Marx Activity Scale scores were predictive of achieving an MCID and SCB on the IKDC, and lower preoperative KOS-ADL scores, lower preoperative SF-36 pain subscale scores, and a history of 1 or less previous ipsilateral knee surgeries were predictive of achieving a MCID and SCB on the KOS-ADL (Table 2).Conclusion:In patients treated for focal cartilage defects of the knee with osteochondral grafts, these values can be used to define a clinically important change and substantial clinical benefit for future outcome studies. In this study population, higher preoperative activity levels and a history of 1 or less previous ipsilateral knee surgeries were predictive of achieving a clinically important change and substantial clinical benefit after OAT/OCA. These findings have implications for managing preoperative expectations of OAT/OCA surgery.Table 1.Patient Demographics and Clinical Variables of Included Patients (N = 173)Age, y33 ± 13.2 Mean ± SD56 (32.4) Age <40 y64 (37.0)Female sex25.8 ± 4.5Body mass index, kg/m2 1.3 ± 1.5No. of previous surgeriesChondral lesion characteristics Lesion location Medial femoral condyle79 (45.7) Lateral femoral condyle59 (34.1) Trochlea28 (16.2) Patella30 (17.3) Lesion area, cm2 4.3 ± 2.6Procedure Osteochondral autograft transfer75 (43.4) Osteochondral allograft transplantation98 (56.7)Concomitant procedures ACLR2 (1.2) Meniscus allograft transplantation7 (4.0) Realignment osteotomy17 (9.8)Data are reported as n (%) unless otherwise indicated. ACLR = anterior cruciate ligament reconstructionTable 2.Multivariable Logistic Models for Achieving MCID and SCBOdds Ratio (95% CI)P ValueAchieving MCID on IKDC Age (≥40 y/<40 y)1.01 (0.43-2.40)0.985 Sex (Female/Male)0.96 (0.43-2.18)0.923 Preoperative IKDC0.95 (0.92-0.98)0.001 Preoperative Marx Activity Scale1.11 (1.03-1.19)0.005Achieving SCB ON IKDC Age (≥40 y/<40 y)0.60 (0.24-1.40)0.244 Sex (Female/Male)0.69 (0.31-1.50)0.360 Preoperative IKDC0.95 (0.92-0.98)0.001 Preoperative Marx Activity Scale1.14 (1.07-1.23)<0.001Achieving MCID and SCB on KOS-ADL Age (≥40 y/<40 y)0.92 (0.40-2.12)0.845 Sex (Female/Male)1.46 (0.67-3.24)0.343 Previous Knee Surgeries (>1/≤1)0.32 (0.14-0.69)0.005 Preoperative KOS-ADL0.96 (0.93-0.99)0.009 Preoperative SF-36 Pain Subscale0.98 (0.96-1.00)0.043IKDC = International Knee Documentation Committee Subject Form; KOS-ADL = Knee Outcome Survey - Activities of Daily Living Scale; MCID = minimal clinically significant difference; SCB = substantial clinical benefit

Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of copd health status tools

BackgroundThe Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George’s Respiratory Questionnaire (SGRQ).MethodsModerate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency.ResultsIn total 451 patients were included (57.9 ± 6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2 ± 7.3 (CAT), 2.9 ± 1.2 (CCQ) and 50.7 ± 17.3 (SGRQ). MCID estimates for improvement ranged − 3.1 to − 1.4 for CAT, − 0.6 to − 0.3 for CCQ, and − 10.3 to − 7.6 for SGRQ. Absolute higher – though not significant – MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference − 1.4: CI -2.3 to − 0.5) and CCQ (difference − 0.2: CI -0.3 to −0.1) using a five-point GRC.ConclusionsThe recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ.Trial registrationRIMTCORE trial #DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).

Minimal important change values for the Oxford Knee Score and the Forgotten Joint Score at 1 year after total knee replacement

Background and purpose — Interpreting changes in Oxford Knee Score (OKS) and Forgotten Joint Score (FJS) following total knee replacement (TKR) is challenged by the lack of methodologically rigorous methods to estimate minimal important change (MIC) values. We determined MIC values by predictive modeling for the OKS and FJS in patients undergoing primary TKR.Patients and methods — We conducted a prospective cohort study in patients undergoing TKR between January 2015 and July 2016. OKS and FJS were completed preoperatively and at 1 year postoperatively, accompanied by a 7-point anchor question ranging from “better, an important improvement” to “worse, an important worsening.” MIC improvement values were defined with the predictive modeling approach based on logistic regression, with patients’ decisions on important improvement as dependent variable and change in OKS/FJS as independent variable. Furthermore, the MICs were adjusted for high proportions of improved patients.Results — 333/496 (67.1%) patients with a median age of 69 years (61% female) had complete data for OKS, FJS, and anchor questions at 1 year postoperatively. 85% were importantly improved. Spearman’s correlations between the anchor and the change score were 0.56 for OKS, and 0.61 for FJS. Adjusted predictive MIC values (95% CI) for improvement were 8 (6–9) for OKS and 14 (10–18) for FJS.Interpretation — The MIC value of 8 for OKS and 14 for FJS corresponds to minimal improvements that the average patient finds important and aids in our understanding of whether improvements after TKR are clinically relevant.

Assessing the Risk-Benefit Ratio of Scoliosis Surgery in Cerebral Palsy: Surgery Is Worth It.

The true benefits of scoliosis surgery in cerebral palsy (CP) remain uncertain. Our aims were to determine the benefits of spinal fusion according to health-related quality of life (HRQoL) improvement at long-term follow-up and to explore the effect of surgery-related complications on clinical outcomes. The cases of consecutive patients who had Gross Motor Function Classification System (GMFCS) level-IV or V cerebral palsy with 5-year follow-up from a prospective, longitudinal, multicenter database were analyzed. Caregivers completed the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire and 4 Likert-type anchor questions preoperatively and at 1, 2, and 5 years of follow-up. Data on complications were collected prospectively. Preoperative CPCHILD scores were compared with postoperative scores at the 1, 2, and 5-year follow-up evaluations. Preoperative CPCHILD scores were compared with postoperative scores at the 1, 2, and 5-year follow-up evaluations using repeated-measures analysis of variance (ANOVA). Spearman correlation coefficient was used to explore the association between changes in the CPCHILD at 1, 2, and 5-year follow-up and the reported complications within the follow-up period. Similarly, a comparative analysis between the percentage distribution of the answers to the 4 anchor questions and the reported complications was also performed. Sixty-nine patients with a mean age (and standard deviation) of 13.4 ± 2.6 years at enrollment were analyzed. The major Cobb angle was a mean of 81.9° ± 26.7° preoperatively and improved to a mean of 28.7° ± 14.4° at 2 years and 30.7° ± 15.3° at 5 years postoperatively. Significant improvements in CPCHILD personal care, positioning, and comfort domains were noted at all time points. The mean increase in the total score was 7.19 (p < 0.001) at 1 year, and the score gain was maintained at 2 and 5 years postoperatively. The overall complication rate was 46.4% at 1 year, 1.4% between 1 and 2 years, and 4.3% at 2 to 5 years postoperatively, with surgical intervention required in 6 patients within 1 year and in 2 additional patients within 5 years following scoliosis surgery. There was no correlation between complications and CPCHILD scores postoperatively at all time points, with the only exception of a weak correlation (ρ = -0.450, p = 0.002) with CPCHILD comfort score at 1 year after surgery. Scoliosis surgery in patients with CP leads to a significant improvement in HRQoL, which is maintained 5 years following surgery. The substantial complication rate does not correlate with HRQoL changes postoperatively, suggesting that the benefits of surgery outweigh the risks in this fragile population. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Meaningful Change Scores in the Knee Injury and Osteoarthritis Outcome Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction

Background: Meaningful change scores in the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing anterior cruciate ligament (ACL) reconstruction have not yet been established. Purpose: To define the minimal important change (MIC) for the KOOS after ACL reconstruction. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: KOOS and anchor questions with 7-point scales ranging from “better, an important improvement” to “worse, an important worsening” were completed postoperatively by randomly chosen participants from the Norwegian Knee Ligament Registry. Presurgery KOOS scores were retrieved from the registry. The MIC for improvement was calculated with anchor-based approaches using the predictive modeling method adjusted for the proportion of improved patients, the mean change method, and the receiver operating characteristic (ROC) method. Results: Complete data for at least one of the KOOS subscales were obtained from 542 (45.3%) participants. Predictive modeling MIC values were 12.1 for the KOOS subscales of Sport and Recreational Function and 18.3 for Knee-Related Quality of Life. These values aid in interpreting within-group improvement over time and can be used as responder criteria when comparing groups. The corresponding and much lower values for the subscales of Pain (2.5), Symptoms (–1.2), and Activities of Daily Living (2.4) are the results from patients reporting, on average, only mild problems with these domains preoperatively. Although 4% to 10% of patients reported subscale-specific worsening, MIC deterioration calculations were not possible. The ROC MIC values were associated with high degrees of misclassification. Values obtained by the mean change method were considered less reliable because these estimates are derived from subgroups of patients. Average KOOS change scores were approximately similar for patients reporting acceptable symptoms postoperatively and patients reporting important improvements on the anchor items after surgery. Conclusion: KOOS users should apply subscale-specific cutoffs for meaningful improvement. Our results confirm using the subscales of Sport and Recreational Function and Knee-Related Quality of Life as primary patient-reported outcomes after ACL reconstruction. The predictive modeling approach gave the most robust estimates of MIC values. Our data suggest that reporting acceptable symptoms postoperatively corresponds to reporting an important improvement after ACL reconstruction.

The responsiveness of the PROMIS instruments and the qDASH in an upper extremity population

BackgroundThis study evaluated the responsiveness of several PROMIS patient-reported outcome measures in patients with hand and upper extremity disorders and provided comparisons with the qDASH instrument.MethodsThe PROMIS Upper Extremity computer adaptive test (UE CAT) v1.2, the PROMIS Physical Function (PF) CAT v1.2, the PROMIS Pain Interference (PI) CAT v1.1 and the qDASH were administered to patients presenting to an orthopaedic hand clinic during the years 2014–2016, along with anchor questions. The responsiveness of these instruments was assessed using anchor based methods. Changes in functional outcomes were evaluated by paired-sample t-test, effect size, and standardized response mean.ResultsThere were a total of 255 patients (131 females and 124 males) with an average age of 50.75 years (SD = 15.84) included in our study. Based on the change and no change scores, there were three instances (PI at 3 months, PI >3 months, and qDASH >3 months follow-ups) where scores differed between those experiencing clinically meaningful change versus no clinically meaningful change. Effect sizes for the responsiveness of all instruments were large and ranged from 0.80–1.48. All four instruments demonstrated high responsiveness, with a standardized response mean ranging from 1.05 to 1.63.ConclusionThe PROMIS UE CAT, PF CAT, PI CAT, and qDASH are responsive to patient-reported functional change in the hand and upper extremity patient population.

Quantifying success after total shoulder arthroplasty: the minimal clinically important difference

Knowledge of the minimal clinically important difference (MCID) for different shoulder outcome metrics and range of motion after total shoulder arthroplasty (TSA) can be useful to establish a minimum threshold of improvement that defines successful treatment. This study quantifies how MCID varies with different prosthesis types, patient age, gender, and length of follow-up after TSA. A total of 466 anatomic TSA (aTSA) and reverse TSA (rTSA) with 2-year minimum follow-up were performed by 13 shoulder surgeons. The MCID for the American Shoulder and Elbow Surgeons, Constant, University of California Los Angeles Shoulder Rating Scale, Simple Shoulder Test, Shoulder Pain and Disability Index, global shoulder function, and visual analog scale for pain scores, as well as active abduction, forward flexion, and external rotation, were calculated for different prosthesis types and patient cohorts using an anchor-based method. The anchor-based MCID results were American Shoulder and Elbow Surgeons = 13.6 ± 2.3, Constant score = 5.7 ± 1.9, University of California Los Angeles Shoulder Rating Scale = 8.7 ± 0.6, Simple Shoulder Test score = 1.5 ± 0.3, Shoulder Pain and Disability Index score = 20.6 ± 2.6, global shoulder function = 1.4 ± 0.3, pain visual analog scale = 1.6 ± 0.3, active abduction = 7° ± 4°, active forward flexion = 12° ± 4°, and active external rotation = 3° ± 2°. Female gender and rTSA were associated with lower MCID values compared with male gender and aTSA patients. The minimum improvement necessary for patients to achieve a result they believe is clinically meaningful after aTSA and rTSA is nominal and was achieved by at least 80% of the patients. Future endeavors should investigate the influence of different anchor questions on the MCID calculation.

Clinical interpretation of the Uremic Pruritus in Dialysis Patients (UP-Dial) scale: a novel instrument for the assessment of uremic pruritus.

The Uremic Pruritus in Dialysis Patients (UP-Dial) scale is valid and reliable for uremic pruritus (UP) assessment. However, it remains unknown how the scores should be interpreted in clinical practices. To establish a clinical interpretation of the UP-Dial by identifying severity cut-off scores according to the disease severity and burden of pruritus. This cross-sectional study developed a classification system for the UP-Dial scores using the patient-based anchors method. From May 2012 through January 2017, 697 dialysis patients were screened. Of these, a total of 258 met the criteria for UP and completed the UP-Dial scale and three sets of patient-assessed anchor questions: (i) global UP intensity by visual analogue scale (VAS)-UP, (ii) Dermatology Life Quality Index and (iii) global kidney disease-related quality of life. The cut-off scores were generated based on the kappa (κ) coefficient of agreement and the area under receiver operating characteristic curve (AuROC) statistics. Subgroup analyses were performed to explore associations between patient characteristics and the UP-Dial severity bands. The proposed scores were ≤12 (mild), 13-21 (moderate) and ≥22 (severe) with κ coefficient ranging between 0.39 and 0.46. Assigned scores were associated with all patient-based anchors. The highest association was with the VAS-UP, and AuROC was 0.80 (mild; 95% CI, 0.75-0.86), 0.66 (moderate; 0.60-0.71) and 0.83 (severe; 0.77-0.89). In subgroup analysis according to patient characteristics, we did not find any significant difference. The estimated UP-Dial severity band can facilitate the interpretation of UP in practice-based research settings and can be used to support treatment decisions.

P.1.k.009 - Is cesarean section associated with risk for autism spectrum disorder?

The purpose of the study was to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) thresholds for the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) computerized adaptive test (CAT) instrument in patients undergoing arthroscopic meniscal surgery.The PROMIS PF CAT was administered preoperatively and postoperatively to patients undergoing arthroscopic meniscal surgery. At 6 months postoperatively, patients graded their knee function based on a domain-specific anchor question. A satisfaction anchor question was used to indicate achievement of the PASS. Receiver operating characteristic analysis determined the relevant psychometric values. Cutoff analysis was performed to find preoperative patient-reported outcome scores predicting achievement of clinically significant outcomes (CSOs).A total of 73 patients (41.1% female patients) were included, with a mean age of 44.9 ± 12.8.0 years and average follow-up period of 24.0 ± 1.2 weeks. The MCID on the PROMIS PF CAT was calculated to be 2.09 (area under the curve [AUC], 0.75; 95% CI, 0.57-0.94). Net score improvement equivalent to achievement of SCB was found to be 6.50 (AUC, 0.77; 95% CI, 0.55-0.99). The PASS was found to be 46.1 (AUC, 0.86; 95% CI, 0.76-0.96). A preoperative score below 37.6 on the PROMIS PF CAT predicted achievement of the MCID (AUC, 0.76; 95% CI, 0.62-0.87), whereas scores above 41.9 predicted achievement of the PASS (AUC, 0.77; 95% CI, 0.65-0.90). Higher baseline functional status and the absence of pre-existing arthritis were also found to be statistically significant predictors of achieving CSOs.Our study defined the MCID, SCB, and PASS for the PROMIS PF CAT. We found that a preoperative score below 37.6 was predictive of achieving a meaningful clinical change with surgery whereas a preoperative score above 41.9 was predictive of patients who would attain an acceptable postoperative health state. In addition, exercising more days per week and the absence of arthritis increased the likelihood of achieving postoperative CSOs.Level III, retrospective cohort.

Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds.

Chronic wounds have a major socioeconomic impact due to their frequency, chronicity, and societal costs. Patients experience substantial quality of life (QoL) impairments. The use of questionnaires for a continuous assessment of QoL and resulting interventions to improve the situation of the individual are an important cornerstone of a guideline-based wound care. The aim of this study was to investigate the validity of the Wound-QoL questionnaire. Patients with chronic wounds from two different centers were included in the prospective study. All patients completed the Wound-QoL and two other QoL questionnaires (European Quality of Life-5 Dimensions, EQ-5D, and Freiburg Life Quality Assessment for wounds, FLQA-wk) at baseline and at two more time points (4 and 8 weeks, respectively). Wound status was defined with an anchor question. Two hundred and twenty-seven patients (48.5% women) participated in the study. Mean age was 66.9 years (range 17-96, median 69.5). Indications were venous leg ulcers (40.1%), pyoderma gangraenosum (14.1%), diabetic or ischemic foot ulcers (5.3%), pressure ulcers (2.6%), and other etiologies (30.0%). The Wound-QoL showed good internal consistency, with high Cronbach's alpha in all the subscales and in the global scale in all time points (>0.8). Convergent validity was satisfactory since there were significantly (p ≤ 0.001) good correlations with the EQ-5D (range = 0.5-0.7) and FLQA-wk global score (r > 0.8) at every time point. Responsiveness was high, too. The Wound-QoL is a simple, valid tool for the longitudinal assessment of QoL in patients with chronic wounds. This questionnaire is suitable for use in clinical trials, quality of care studies and clinical routine.

Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF)

BackgroundThe Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF) is a patient-reported outcome measurement designed to evaluate the symptoms of hypogonadism. The HIS-Q-SF is an abbreviated version including17 items from the original 28-item HIS-Q. AimTo conduct item analyses and reduction, evaluate the psychometric properties of the HIS-Q-SF, and provide guidance on score interpretation. MethodsA 12-week observational longitudinal study of hypogonadal men was conducted as part of the original HIS-Q psychometric evaluation. Participants completed the original HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants completed the Aging Male’s Symptoms Scale, the International Index of Erectile Function, the Short Form-12, and the PROMIS Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change scales and a clinical form. Main Outcome MeasuresItem performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. ResultsOne hundred seventy-seven men participated (mean age = 54.1 years, range = 23–83). Similar to the full HIS-Q, the final abbreviated HIS-Q-SF instrument includes five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For key domains, test-retest reliability was very good, and construct validity was good for all domains. Known-groups validity was demonstrated for all domain scores, subdomain scores, and total score based on the Clinical Global Impression–Severity. All domains and subdomains were responsive to change based on patient-rated anchor questions. Clinical ImplicationsThe HIS-Q-SF could be a useful tool in clinical practice, epidemiologic studies, and other academic research settings. Strengths and LimitationsCareful consideration was given to the selection of the final HIS-Q-SF items based on quantitative data and clinical expert feedback. Overall, the reduced set of items demonstrated strong psychometric properties. Testosterone levels for the participating men were not as low as anticipated, which could have limited the ability to examine the relations between the HIS-Q-SF and testosterone levels. Further, the analyses used data collected through administration of the full HIS-Q, and future studies should administer the standalone HIS-Q-SF to replicate the psychometric analyses reported in the present study. ConclusionSimilar to the original HIS-Q, the HIS-Q-SF has evidence supporting reliability, validity, and responsiveness. The short form includes a smaller set of items that might be more suitable for use in clinical practice or academic research settings.Gelhorn HL, Roberts LJ, Khandelwal N, et al. Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF). J Sex Med 2017;14:1046–1058.

Arthroscopic Treatment of Femoroacetabular Impingement in Adolescents Provides Clinically Significant Outcome Improvement

To define minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for adolescents undergoing arthroscopic femoroacetabular impingement (FAI) surgery. A prospective institutional hip preservation registry was reviewed to identify hip arthroscopies performed for FAI. Patients with pre-existing hip conditions such as slipped capital femoral epiphysis and Legg-Calve-Perthese were excluded. Included patients were 18years and younger. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS), and the international Hip Outcome Tool (iHOT-33) were administered as part of the registry. MCID was calculated using a distribution-based method, and SCB was calculated using a physical function anchor question. Receiver operating characteristic analysis with area under the curve (AUC) was used for psychometric analyses. Forty-seven adolescents were identified. The majority of patients were female (n= 32, 68.1%) with a mean age of 16.5 (±1.1) years. The MCID (% achieving) for the mHHS, HOS activities of daily living (ADL), HOS Sport, and iHOT-33 was 9.5 (85%), 9.8 (79%), 12.1 (85%), and 10.7 (94%), respectively. Ninety-two percent of adolescents reported some form of improved hip physical ability on the anchor question. The following 1-year absolute outcome scores were significantly representative of an SCB state on the mHHS, HOS ADL, HOS Sport, and mHHS, respectively (AUC): 93.5 (0.79), 98.5 (0.84), 96.9 (0.81), and 85.9 (0.76). Adolescents undergoing arthroscopic FAI surgery achieve clinically significant outcome improvement. We found that the vast majority of adolescents achieve MCID on hip-specific patient-reported outcome tools. However, although adolescents readily achieve MCID, a considerable improvement in postoperative outcome score is often needed to perceive a substantial benefit (SCB). The available hip outcome tools may be subject to ceiling effects for measuring clinically significant outcome improvement in adolescents. Level IV, case series.

The Responsiveness and Minimal Important Change of the Western Ontario Shoulder Instability Index and Oxford Shoulder Instability Score.

Study Design Prospective cohort study. Background Patient-reported outcome measurements (PROMs) are widely used to evaluate functional limitations. Considering PROMs for shoulder instability, information is lacking with regard to what constitutes a relevant change from baseline scores. Objectives To evaluate the responsiveness of the Western Ontario Shoulder Instability Index (WOSI) and the Oxford Shoulder Instability Score (OSIS) and estimate their minimal important change (MIC). Methods One hundred five consecutive patients with shoulder instability completed 5 PROMs at baseline and at 6-month follow-up. The PROMs included the WOSI and OSIS, the Simple Shoulder Test, the Oxford Shoulder Score, and the Disabilities of the Arm, Shoulder and Hand assessment. Patients also rated their functional change on an anchor question at follow-up. Responsiveness was evaluated by testing 9 hypotheses regarding predefined correlations between the changes in PROM scores, by calculating the area under the receiver operating characteristic curve and by calculating the standardized response mean and effect size statistics. The MIC was determined by identifying the optimal cutoff on the receiver operating characteristic curve. Results Seven out of 9 hypotheses (78%) were confirmed; as expected, a high correlation (0.77) was found between change scores of the WOSI and OSIS, whereas the correlations of the change scores of the WOSI and OSIS with those of general shoulder PROMs were slightly lower (0.61-0.75). The area under the curve was 0.83 (95% confidence interval: 0.75, 0.91) for the OSIS and 0.82 (95% confidence interval: 0.74, 0.90) for the WOSI. The MIC was about 6 points for the OSIS and about 14 points for the WOSI. Conclusion Both the WOSI and OSIS are able to measure change in shoulder function in patients with shoulder instability. The estimated MIC is 6 points for the OSIS (on a scale from 0 to 48) and 14 points for the WOSI (on a scale from 0 to 100). J Orthop Sports Phys Ther 2017;47(6):402-410. doi:10.2519/jospt.2017.6548.

Does Hip Arthroscopy Provide Meaningful Outcome Improvement for Adolescent Femoroacetabular Impingement

Objectives:Arthroscopic treatment of femoroacetabular impingement (FAI) produces meaningful outcome improvement in adults. Hip arthroscopy for pediatric FAI is now established as a safe procedure however there is a paucity of evidence reporting on outcome improvement after arthroscopic treatment of FAI in this population.Methods:A prospective institutional hip preservation registry was reviewed to identify hip arthroscopies performed for pediatric FAI. Patients with pre-existing hip conditions such as slipped capital femoral epiphysis and Legg-Calve-Perthese were excluded. Included patients were 18 years and younger. The modified Harris Hip Score (mHHS), the Hip Outcome Score (HOS) and the international Hip Outcome Tool (iHOT-33) are routinely collected as part of the registry. Minimal clinically important difference (MCID) was calculated using a distribution based method and substantial clinical benefit (SCB) was calculated using the an anchor question. Receiver operating characteristic (ROC) analysis with area under the curve was used. AUC > 0.7 was considered significantly predictive.Results:Forty-seven children and adolescents were identified. The majority of patients were female (N=32, 68.1%) with a mean age of 16.5 (+ 1.1) years. The MCID (% achieving) for the mHHS, HOS activities of daily living (ADL), HOS Sport and iHOT-33 was 9.5 (85%), 9.8 (79%), 12.1 (85%) and 10.7 (94%) respectively. MCID values on these outcome tools were comparable to adult patients within the registry however for each outcome measure pediatric patients were more likely to achieve MCID. In univariate analysis acetabular version was the only predictive variable for achieving MCID in pediatric FAI (p<0.05). The majority of children (91%) reported improved physical ability based on the anchor question and 53% (compared to 40% in adult registry patients) were classified as achieving SCB. The following one-year raw outcome scores were significantly predictive of SCB on the mHHS, HOS ADL, HOS Sport and mHHS respectively (AUC): 93.5 (0.79), 98.5 (0.84), 96.9 (0.81), 85.9 (0.76). These pediatric SCB values were all higher than SCB values for adult registry patients (82.5, 93.3, 84.4, 63.5 respectively)Conclusion:Pediatric patients undergoing arthroscopic FAI treatment can achieve meaningful outcome improvement and compared to adults, a larger proportion of children achieve meaningful outcome improvement. Additionally, while MCID values are comparable in children and adults, children appear to require substantially higher overall post-operative scores to perceive SCB. These findings highlight that commonly administered adult FAI outcome tools may have a relative ceiling effect in capturing outcome after treatment of pediatric FAI.

Determining the Patient Acceptable Symptomatic State for Patients Undergoing Arthroscopic Partial Meniscectomy in the Knee

Objectives:Arthroscopic partial meniscectomy is one of the most commonly performed procedures in orthopaedic surgery. However, information on the threshold at which patients consider themselves to be well for patient reported outcome measures (PROMs) after this surgery remains limited. Our goal was to determine the patient acceptable symptomatic state (PASS) for the Knee Injury and Osteoarthritic Outcome Score (KOOS), the International Knee Documentation Committee (IKDC) Subjective Knee Form, the Western Ontario Meniscal Evaluation Tool (WOMET) and the Marx Activity Scale (MAS) in patients with knee meniscal pathology who treated with partial knee meniscectomy.Methods:A consecutive series of patients with knee meniscal pathology treated with arthroscopic partial meniscectomy plus or minus intra-articular debridement were eligible. Other inclusion criteria were: a Kellegren-Lawrence Grade of 0-2, and ligamentous integrity. The KOOS (0-100, 5 subscales), IKDC (0-100), WOMET (0-100) and MAS (0-16) were administered at baseline and 12 months postoperatively. An external anchor question at 1 year postoperatively was utilized to determine PASS values: “Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?” A receiver operator curve analysis was used to determine the PASS value at which patients considered their status to be satisfactory.Results:There were 115 patients (mean ± SD age, 53.8 ± 12.0 years), and 57.3% were male. Based on a receiver operator curve analysis, the PASS values - at which patients considered their status to be satisfactory - at 1 year after surgery were 43 (KOOS-symptoms subscale), 83 (KOOS-pain subscale), 84 (KOOS-functions of daily living subscale), 75 (KOOS-function, sport and recreational activity subscale), 56 (KOOS-quality of life subscale), 56 (IKDC), 61 (WOMET), 7 (MAS). The PASS threshold was not affected by baseline scores across the different instruments and there was no relationship between baseline score and likelihood of achieving the PASS. Age and sex were not significantly related to the odds of achieving the PASS for any of the PROMs.Conclusion:This is the first study to determine PASS in four commonly used knee-related PROMs in patients undergoing arthroscopic partial meniscectomy. The findings can allow researchers and clinicians to determine if partial meniscectomy is meaningful to patients and will be helpful for responder analysis in future trials related to knee arthroscopy and the treatment of meniscal pathology.

Minimal Clinically Important Differences for American Orthopaedic Foot & Ankle Society Score in Hallux Valgus Surgery.

The American Orthopaedic Foot & Ankle Society (AOFAS) score is one of the most common and adapted outcome scales in hallux valgus surgery. However, AOFAS is predominantly physician based and not patient based. Although it may be straightforward to derive statistical significance, it may not equate to the true subjective benefit of the patient's experience. There is a paucity of literature defining MCID for AOFAS in hallux valgus surgery although it could have a great impact on the accuracy of analyzing surgical outcomes. Hence, the primary aim of this study was to define the Minimal Clinically Important Difference (MCID) for the AOFAS score in these patients, and the secondary aim was to correlate patients' demographics to the MCID. We conducted a retrospective cross-sectional study. A total of 446 patients were reviewed preoperatively and followed up for 2 years. An anchor question was asked 2 years postoperation: "How would you rate the overall results of your treatment for your foot and ankle condition?" (excellent, very good, good, fair, poor, terrible). The MCID was derived using 4 methods, 3 from an anchor-based approach and 1 from a distribution-based approach. Anchor-based approaches were (1) mean difference in 2-year AOFAS scores of patients who answered "good" versus "fair" based on the anchor question; (2) mean change of AOFAS score preoperatively and at 2-year follow-up in patients who answered good; (3) receiver operating characteristic (ROC) curves method, where the area under the curve (AUC) represented the likelihood that the scoring system would accurately discriminate these 2 groups of patients. The distribution-based approach used to calculate MCID was the effect size method. There were 405 (90.8%) females and 41 (9.2%) males. Mean age was 51.2 (standard deviation [SD] = 13) years, mean preoperative BMI was 24.2 (SD = 4.1). Mean preoperative AOFAS score was 55.6 (SD = 16.8), with significant improvement to 85.7 (SD = 14.4) in 2 years ( P value < .001). There were no statistical differences between demographics or preoperative AOFAS scores of patients with good versus fair satisfaction levels. At 2 years, patients who had good satisfaction had higher AOFAS scores than fair satisfaction (83.9 vs 78.1, P < .001) and higher mean change (30.2 vs 22.3, P = .015). Mean change in AOFAS score in patients with good satisfaction was 30.2 (SD = 19.8). Mean difference in good versus fair satisfaction was 7.9. Using ROC analysis, the cut-off point is 29.0, with an area under the curve (AUC) of 0.62. Effect size method derived an MCID of 8.4 with a moderate effect size of 0.5. Multiple linear regression demonstrated increasing age (β = -0.129, CI = -0.245, -0.013, P = .030) and higher preoperative AOFAS score (β = -0.874, CI = -0.644, -0.081, P < .001) to significantly decrease the amount of change in the AOFAS score. The MCID of AOFAS score in hallux valgus surgery was 7.9 to 30.2. The MCID can ensure clinical improvement from a patient's perspective and also aid in interpreting results from clinical trials and other studies. Level III, retrospective comparative series.

The colostomy impact score: development and validation of a patient reported outcome measure for rectal cancer patients with a permanent colostomy. A population‐based study

The aim was to develop and validate a simple scoring system evaluating the impact of colostomy dysfunction on quality of life (QOL) in patients with a permanent stoma after rectal cancer treatment. In this population-based study, 610 patients with a permanent colostomy after previous rectal cancer treatment during the period 2001-2007 completed two questionnaires: (i) the basic stoma questionnaire consisting of 22 items about stoma function with one anchor question addressing the overall stoma impact on QOL and (ii) the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Answers from half of the cohort were used to develop the score and subsequently validated on the remaining half. Logistic regression analyses identified and selected items for the score and multivariate analysis established the score value allocated to each item. The colostomy impact score includes seven items with a total range from 0 to 38 points. A score of ≥10 indicates major colostomy impact (Major CI). The score has a sensitivity of 85.7% for detecting patients with significant stoma impact on QOL. Using the EORTC QLQ scales, patients with Major CI experienced significant impairment in their QOL compared to the Minor CI group. This new scoring system appears valid for the assessment of the impact on QOL from having a permanent colostomy in a Danish rectal cancer population. It requires validation in non-Danish populations prior to its acceptance as a valuable patient-reported outcome measure for patients internationally.