Patient Acceptable Symptom State Score Research Articles

10-Year Heterogeneity of Minimal Important Change and Patient Acceptable Symptom State After Lumbar Fusions.

Cohort study. To evaluate heterogeneity (fluctuation) in minimal important change (MIC) and patient acceptable symptom state (PASS) for patient-reported outcomes (PROMs) through 10 years after lumbar fusion. PROMs have become key determinants in spine surgery outcomes studies. MIC and PASS were established to aid PROM interpretations. However, their long-term stability has not yet been reported. A consecutive series of elective lumbar fusions were followed-up using the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) for pain. Improvement was rated by a 4-point Likert scale into "improved" or "non-improved". Satisfaction-to-treatment was rated by the patients' willingness to undergo surgery again. Receiver operating characteristics (ROC) curve analysis estimated MIC (95% confidence interval, CI) as the PROM change that best predicted improvement at distinct time-points. PASS (CI) was estimated as the lowest PROM score at which the patients were still satisfied. Heterogeneity across thresholds was evaluated using the DeLong algorithm. MIC for ODI represented heterogeneity across 10-years, ranging from -21 (-24 to -16) at 2-years to -8 (-7 to -4) at 5-years, P <0.001. The areas under the ROC curves (AUCs) (0.79-0.85) indicated acceptable to excellent discrimination. Heterogeneity was not significant in the MICs for the pain scores. At 1-year, MIC for back pain was -24 (-38 to -15), AUC 0.77, and for leg pain it was -26 (-44 to -8), AUC 0.78. No significant heterogeneity was observed in 10-year PASS scores. At 1-year, PASS for ODI was 22 (15 to 29), AUC 0.85. Similarly, 1-year PASS for back pain was 38 (20 to 56), AUC 0.81, and for leg pain it was 49 (26 to 72), AUC 0.81. MIC for ODI fluctuated over 10-years after lumbar fusions. PASS values for all PROMs seemed most stable over time. Caution is needed when generic MIC values are used in long-term studies. Therapeutic Level III.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis

BackgroundClinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. Materials & MethodsConsecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods was used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. ResultsThere were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = 0.014) but not for SCB (P = 0.053) or PASS (P = 0.620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At two-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = 0.003, SCB:94.6%, 86.4%, P = 0.036). ConclusionCalculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Effect of Patient Characteristics on the Minimal Clinically Important Difference and Patient Acceptable Symptom State Thresholds After Arthroscopic Bankart Repair

Background: There is scarce literature on clinically significant values after arthroscopic Bankart repair (ABR). Purpose: To determine the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) thresholds at 1 year for the Rowe and Athletic Shoulder Outcome Scoring System (ASOSS) scores after ABR and to determine the effect of patient characteristics on these metrics after ABR. Study Design: Case series; Level of evidence, 4. Methods: A retrospective review of patients undergoing ABR from a single institution between January 2017 and January 2020 was performed. Patients with at least 1 episode of instability and a minimum follow-up of 12 months were included. The exclusion criteria were as follows: bony defects of >20% on the anteroinferior portion of the glenoid based on a preoperative computed tomography scan; engaging Hill-Sachs lesions at 90° of abduction and 90° of external rotation based on an arthroscopic examination; previous surgery on the same shoulder; multidirectional instability or concomitant repair of full-thickness rotator cuff tears; superior labral anterior to posterior lesions; posterior labral tears; or humeral avulsion of the glenohumeral ligament lesions. Patient-reported outcome measures were collected both preoperatively and 1-year postoperatively. Delta was defined as the change between preoperative and 1-year postoperative scores. Distribution-based (one-half the standard deviation of the difference between pre- and postoperative outcome scores) and anchored-based approaches (response to a satisfaction question at 1 year) were used to estimate the MCID and the PASS, respectively. The optimal cutoff point, where sensitivity and specificity were maximized, and the percentage of patients achieving those thresholds were also calculated. Results: Overall, 190 patients were included. The distribution-based MCID for the Rowe and ASOSS scores were calculated to be 8.2 and 8.7, respectively. The rate of patients who achieved MCID thresholds was 96% for the Rowe and 96% for ASOSS scores. The PASS threshold for the Rowe and ASOSS scores were ≥80 and ≥90, respectively. The rate of patients who achieved PASS scores after ABR were 86% and 83%, respectively. The MCID and PASS values showed great variability based on sex (men: 8.5 and ≥85 for Rowe / 8.9 and ≥90 for ASOSS, respectively, vs women: 6.7 and ≥73 for Rowe / 8.1 and ≥75 for ASOSS), age (≥21: 8.4 and ≥80 / 9.2 and ≥90 vs <21: 7.8 and ≥75 / 7.7 and ≥85), sports participation (sports: 8.8 and ≥85 / 9.5 and ≥90 vs no sports: 8.1 and ≥75 / 8.6 and ≥80), and type of athlete (competitive: 8.4 and ≥85 / 8.9 and ≥87 vs recreational: 7.5 and ≥73 / 8.1 and ≥68). Conclusion: This study identified the MCID and PASS thresholds for the Rowe and ASOSS scores at 1 year after ABR. However, these values showed great variability when accounting for different patient characteristics such as sex, age, sports participation, and type of athlete, highlighting the importance of considering individual patient-specific characteristics for optimal treatment decision-making and ensuring treatment success tailored to each patient’s unique needs and expectations.

Determining the Time Required to Achieve Clinically Significant Outcomes on the PROMIS Upper Extremity Questionnaire After Arthroscopic Rotator Cuff Repair.

Clinically significant outcome (CSO) thresholds for the Patient-Reported Outcome Measurement Information System-Upper Extremity (PROMIS-UE) score have been previously defined after arthroscopic rotator cuff repair (RCR). However, the time required to achieve CSOs for the PROMIS-UE score is unknown. To (1) determine the time required to achieve the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) score thresholds after RCR for the PROMIS-UE questionnaire and (2) identify patient factors associated with earlier or delayed achievement of these clinical benchmarks. Case-control study; Level of evidence, 3. A prospectively maintained institutional database was retrospectively reviewed for consecutive patients who underwent RCR between January 2018 and January 2019. Patients were included if they completed the PROMIS-UE questionnaire both preoperatively and at standardized postoperative time intervals: 5 to 7 months (6-month time point), 11 to 13 months (1-year time point), and ≥23 months (2-year time point). Kaplan-Meier survival curves with interval censoring were used to define the cumulative percentage of patients who achieved the MCID, SCB, and PASS. Patient variables associated with earlier or delayed achievement of the MCID, SCB, and PASS were determined using Weibull parametric survival regression analysis. Included were 105 patients undergoing RCR (age, 57.3 ± 10.3 years; body mass index, 31.5 ± 6.1 kg/m2). By 2-year follow-up, the cumulative percentage of patients achieving the MCID, SCB, and PASS was 86.7%, 76.2%, and 74.3%, respectively. The mean time required to reach the MCID, SCB, and PASS score thresholds was 9.5 ± 3.8, 10.3 ± 4.4, and 9.8 ± 4.6 months, respectively. Factors associated with delayed achievement of CSOs included greater baseline PROMIS-UE score (MCID and SCB) and workers' compensation insurance (PASS). Greater baseline PROMIS-UE scores were associated with earlier achievement of the PASS. Most patients achieved CSOs for the PROMIS-UE within 12 months of RCR. Patient-specific factors found to be associated with earlier or delayed achievement of CSOs can be used to inform patient discussions on the expected timeline for recovery after RCR.

Identifying Aseptic Revision Total Knee Arthroplasty Diagnoses That Achieve Minimal Clinically Important Difference and Patient Acceptable Symptom State

BackgroundMinimal clinically important difference (MCID) defines a meaningful clinical change in patient-reported outcome measures. Patient acceptable symptom state (PASS) provides a patient-reported outcome measures threshold value to indicate a satisfactory clinical state. MCID and PASS for revision total knee arthroplasty (rTKA) are ill-defined. Moreover, it is unknown whether diagnosis influences the likelihood of achieving MCID or PASS. The purpose of this study was to calculate MCID for aseptic rTKA and compare the percentage of patients achieving MCID and PASS per diagnosis. MethodsAn institutional registry of rTKA was used. First-time aseptic rTKA were included. Demographics, revision diagnosis, preoperative Knee Injury and Osteoarthritis Outcome Score, Jr (KOOS Jr), and 1-year postoperative KOOS Jr were recorded. The 1-year postoperative KOOS Jr PASS score was available. MCID was calculated using distribution-based methods. Three hundred fifty eight first-time aseptic rTKAs were analyzed. The 3 most common diagnoses were aseptic loosening (n = 156), instability (n = 109), and stiffness (n = 37). ResultsThe mean KOOS Jr 1-year postoperative MCID for rTKA was 10.3. Overall, 75.4% achieved MCID and 56.9% achieved PASS. The percentage of patients per diagnosis achieving MCID and PASS, respectively, were periprosthetic fracture (100, 44), aseptic loosening (94, 60), implant fracture (88, 63), stiffness (60, 38), instability (59, 61), polyethylene wear/osteolysis (57, 57), and metal allergy (44, 33). ConclusionAseptic rTKA MCID is 10.3 for KOOS Jr at 1 year postoperatively. rTKA outcomes vary depending on preoperative diagnosis. Even in diagnoses with a high proportion of MCID achieved, less than 2/3 of patients achieved PASS, suggesting rTKA provides noticeable improvement but may not return patients to a satisfactory state.

Patient Reported Outcomes Analysis with Cartiva Implant

Category: Midfoot/Forefoot; Other Introduction/Purpose: There has been an increased use of Cartiva implant in patients with first MTP arthritis. There are limited studies analyzing patient reported outcomes (PROs) with Cartiva implant. The goal of this study is to analyze validated patient reported outcomes on Cartiva patients. Methods: From a multi-center single institution, we analyzed patients who received the Cartiva implant and submitted PROs from December 2016 to December 2019. The following outcomes were analyzed: Foot and Ankle Ability Measure (FAMM), Global Rate of Change (GRC), and Patient Acceptable Symptom State (PASS). The PROs were analyzed by examining the postoperative score at any time interval after the procedure, a difference between preoperative score and postoperative time interval score (delta score), and at different time periods 0-2 months and &gt;2 months after the procedure. Results: Of the 175 Cartiva patients, the average age was 57.1 years with 68% females and 32% males. The overall mean delta FAMM score was 5.5. The mean FAMM score at 0-2 months were 61.6 with the mean delta score -9.2. At &gt; 2 months, the mean FAMM score was 74.7, and the mean delta score was 10.9. With GRC scores, overall GRC score 45.6 % report better, 35.1% report no change, 11.9% report worse. At 0-2 months, 38.1% report better, 42.9% report no change, and 19.1 % report worse. At &gt; 2 months, 41.2% report better, 35.3% no change, 23.5% report worse. As for PASS scores, 53.3% said no, and 46.6% said yes. Conclusion: Overall FAMM scores with Cartiva implant overall show improvement compared to preoperative score. FAMM scores at 0-2 months are worse than preoperative but are better at &gt;2month timeframe. There is a minimal difference between patients feeling better or no change after their procedure in GRC and PASS scores and analyzing at 0-2 and &gt;2 month timeframes. Further studies are needed.

Harmonising knee pain patient-reported outcomes: a systematic literature review and meta-analysis of Patient Acceptable Symptom State (PASS) and individual participant data (IPD)

In order to facilitate data pooling between studies, we explored harmonisation of patient-reported outcome measures (PROMs) in people with knee pain due to osteoarthritis or knee trauma, using the Patient Acceptable Symptom State scores (PASS) as a criterion. We undertook a systematic literature review (SLR) of PASS scores, and performed individual participant data (IPD) analysis of score distributions from concurrently completed PROM pairs. Numerical rating scales (NRS), visual analogue scales, KOOS and WOMAC pain questionnaires were standardised to 0 to 100 (worst) scales. Meta-regression explored associations of PASS. Bland Altman plots compared PROM scores within individuals using IPD from WebEx, KICK, MenTOR and NEKO studies. SLR identified 18 studies reporting PASS in people with knee pain. Pooled standardised PASS was 27 (95% CI: 21 to 35; n=6,339). PASS was statistically similar for each standardised PROM. Lower PASS was associated with lower baseline pain (β=0.49, P=0.01) and longer time from treatment initiation (Q=6.35, P=0.04). PASS scores were lowest in ligament rupture (12, 95% CI: 11 to 13), but similar between knee osteoarthritis (31, 95% CI: 26 to 36) and meniscal tear (27, 95% CI: 20 to 35). In IPD, standardised PROMs each revealed similar group mean scores, but scores within individuals diverged between PROMs (LoA between-7 to-38 and+25 to 52). Different standardised PROMs give similar PASS thresholds in group data. PASS thresholds may be affected more by patient and treatment characteristics than between PROMs. However, different PROMs give divergent scores within individuals, possibly reflecting different experiences of pain.

Paper 56: Defining Clinically Significant Outcomes After Gluteus Medius Repair at 5-Years

Objectives:To define minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) at a minimum of 5-years for patients undergoing endoscopic and open gluteus medius repair.Methods:A retrospective review was performed of prospectively collected data from all patients undergoing primary open or endoscopic repair of gluteus medius tears between January 2012 and December 2015 with a minimum 5-years follow-up. Patient data collected included patient demographics, preoperative clinical function scores, and pre and postoperative patient-reported outcomes (PROs). Patient reported outcome measures included the Hip Outcome Score Activities of Daily Living (HOS-ADL) and Sports Subscale (HOS-SS), Modified Harris Hip Score (mHHS) and Internation Hip Outcome Tool 12 questions (iHOT-12). The minimal clinically important difference (MCID) values were calculated for each PRO using the distribution method while PASS was determined via the anchor-based method utilizing ROC curves and Youden’s index using SPSS Statistics (Version 27, IBM, Armonk, NY).Results:A total of 46 patients were included in the study. A majority of patients were female (91.3%), with an average age and BMI of 61.26 ± 9.74 and 27.42 ± 6.02, respectively. Differences in preoperative and 5-year postoperative PROs were statistically significant for each of the four measures (p<0.001). The MCID threshold values for the Hip Outcome Score-Activities of Daily Living (HOS-ADL), Sport-Specific (HOS-SS) subscale, modified Harris Hip Score (mHHS), and the international Hip Outcome Tool-12 (iHOT) were calculated to be 13.1, 14.5, 12.6 and 11.2 respectively. The PASS scores of HOS-ADL, HOS-SS, mHHS and iHOT were calculated to be 85.6, 79.7, 68.2 and 60.5 respectively. In addition, 86.1% of patients achieved either MCID or PASS postoperatively, with 90.9% and 69.8% reaching at least 1 threshold score for achieving MCID and PASS respectively, and 69.7% achieving both any MCID and any PASS.Conclusions:In patients undergoing open or endoscopic gluteus medius repair, our study defines MCID and PASS at mid-term follow-up. A majority of patients achieved any MCID (90.9%) and any PASS (69.7%) at 5-years postoperatively.

Meaningful values in the Short Form Health Survey-36 after total knee arthroplasty - an alternative to the EuroQol five-dimension index as a measure for health-related quality of life : minimal clinically important difference, minimal important change, patient-acceptable symptom state thresholds, and responsiveness.

AimsTo identify the responsiveness, minimal clinically important difference (MCID), minimal clinical important change (MIC), and patient-acceptable symptom state (PASS) thresholds in the 36-item Short Form Health Survey questionnaire (SF-36) (v2) for each of the eight dimensions and the total score following total knee arthroplasty (TKA).MethodsThere were 3,321 patients undergoing primary TKA with preoperative and one-year postoperative SF-36 scores. At one-year patients were asked how satisfied they were and “How much did the knee arthroplasty surgery improve the quality of your life?”, which was graded as: great, moderate, little (n = 277), none (n = 98), or worse.ResultsPhysical function, role limitations due to physical problems (‘role physical’), bodily pain, and the total score SF-36 scores demonstrated the greatest effect sizes (> 0.9). The MCID for each of SF-36 dimensions ranged from 1.7 for role emotional to 6.4 for bodily pain. The MICs for a cohort of patients ranged from -1.0 for general health to 11.1 for bodily pain. The MICs for an individual patient were marginally greater (one to two points) compared to those for a cohort, and ranging from 0.0 for general and mental health to 13.5 for physical function. The lowest PASS score threshold was associated with physical function (> 34 points) whereas the greatest threshold (> 69 points) was associated with mental health.ConclusionThe SF-36 is a responsive tool, and the estimates for MCID, MIC, and PASS thresholds that can be used to power studies, assess whether there has been a meaningful change in patients’ health-related quality of life, and can be used as a marker of achieving patient satisfaction following TKA.Cite this article: Bone Joint Res 2022;11(7):477–483.

Retrospective study on the safety of COVID-19 vaccination in myasthenia gravis.

Introduction/AimGiven the lack of information on safety of coronavirus disease 2019 (COVID‐19) vaccination in myasthenia gravis (MG) patients, we aimed to review our experience after surveying patients, as part of routine clinical practice, to ensure that advice on safety is accurate.MethodsWe performed a retrospective chart review of MG patients from the Prosserman Family Neuromuscular Clinic at the Toronto General Hospital who received two injections of any COVID‐19 vaccine from February to August 2021. Demographic data were abstracted from the patient medical records. We assessed changes in the severity of MG using the virtual Myasthenia Gravis Impairment Index (vMGII), the simple single question (SSQ), and Patient Acceptable Symptom State (PASS). We also assessed adverse effects after vaccination.ResultsWe included 200 patients with a mean age of 64.3 ± 13.9 y, 51.5% were men, and 82% had generalized MG. The vMGII, SSQ, and PASS scores remained stable after each vaccine dose, and at last follow‐up. Of the patients, 60% reported an adverse reaction after the first injection, and 56% after the second. The most common adverse reactions reported were local pain at the injection site, fatigue, headache, and fever.DiscussionCOVID‐19 vaccinations were well tolerated in MG patients and were not associated with worsening severity of their MG. The prevalence of vaccine‐related adverse reactions was the same as in the general population.

Characteristics and outcomes of L-shaped and reverse L-shaped rotator cuff tears

The aim of this study was to compare the characteristics and outcomes of L-shaped and reverse L-shaped rotator cuff tears. A total of 82 shoulders (81 patients) after arthroscopic rotator cuff repair were retrospectively enrolled. The mean age of the patients was 62 years (SD 6), 33 shoulders (40.2%) were in male patients, and 57 shoulders (69.5%) were the right shoulder. Of these, 36 shoulders had an L-shaped tear (group L) and 46 had a reverse L-shaped tear (group RL). Both groups were compared regarding characteristics, pre- and postoperative pain, and functional outcomes. Muscle status was assessed by preoperative MRI, and re-tear rates by postoperative ultrasonography or MRI. Patients in group RL were significantly older than in group L (p = 0.008), and group RL was significantly associated with female sex (odds ratio 2.5 (95% confidence interval 1.03 to 6.32); p = 0.041). Mean postoperative pain visual analogue scale (VAS) score was significantly greater (group L = 0.8 (SD 1.5), group RL = 1.7 (SD 2.2); p = 0.033) and mean postoperative American Shoulder and Elbow Surgeons (ASES) score was significantly lower in group RL than group L (group L = 91.4 (SD 13.1), group RL = 83.8 (SD 17.9); p = 0.028). However, postoperative mean VAS for pain and ASES score were not lower than the patient-acceptable symptom state scores. Mean retracted tear length was significantly larger in group L (group L = 24.6 mm (SD 6.5), group RL = 20.0 mm (SD 6.8); p = 0.003). Overall re-tear rate for 82 tears was 11.0% (nine shoulders), and re-tear rates in group L and RL were similar at 11.1% (four shoulders) and 10.9% (five shoulders), respectively (p = 1.000). No significant intergroup difference was found for fatty degeneration (FD) or muscle atrophy. Within group L, postoperative FD grades of supraspinatus and subscapularis worsened significantly (p = 0.034 and p = 0.008, respectively). Mean postoperative pain VAS (male = 1.2 (SD 1.8), female = 1.3 (SD 2.0)) and ASES scores (male = 88.7 (SD 15.5), female = 86.0 (SD 16.8)) were similar in male and female patients (p = 0.700 and p = 0.475, respectively). Regression analysis showed age was not a prognostic factor of postoperative pain VAS or ASES scores (p = 0.188 and p = 0.150, respectively). Older age and female sex were associated with reverse L-shaped tears. Although the postoperative functional outcomes of patients with reverse L-shaped tears were satisfactory, the clinical scores were poorer than those of patients with L-shaped tears. Surgeons should be aware of the differences in clinical outcome between L-shaped and reverse L-shaped rotator cuff tears. Cite this article: Bone Joint J2022;104-B(3):394-400.

Relationship between patient acceptable symptom state and disease scores in psoriasis.

Patient acceptable symptom state (PASS) is a patient-reported outcome that reflects patients' perspective well. The relationship between the PASS and disease scores in psoriasis has not been described. The aim of the present study was to investigate the association of PASS with Psoriasis Area and Severity Index (PASI) and body surface area (BSA) affected by lesions in patients with psoriasis. A sectional study was conducted. PASS was evaluated by a binary question on the patient's feeling that they have about their symptoms. Clinical data including PASI, BSA, and other patient characteristics were collected. Logistic regression was used to investigate the associations. Receiver-operator curve (ROC) analysis was utilized to determine the PASI/BSA thresholds for PASS. A total of 198 participants (27.8% female, mean age 41.9±12.6years, mean disease duration 10.2±8.6years) completed this study. Of patients with mild psoriasis, 71.4% based on PASI and 76.3% based on BSA considered their symptom state acceptable. Female sex (adjusted odds ratio [OR]=0.47; 95% confidence interval [CI=0.42-0.92) and patients with exposed skin involved (adjusted OR=0.38; 95% CI=0.19-0.76) were less likely to report acceptable symptom state. The threshold for differentiating psoriasis patients in PASS was 3.85 (area under the curve [AUC], 0.67; sensitivity, 0.67; specificity, 0.60) for PASI and 2.85% (AUC, 0.66; sensitivity, 0.79; specificity, 0.54) for BSA, respectively. These results showed that mild psoriasis based on PASI/BSA score align well with PASS status. Female and exposed skin involved are risk factors for acceptable status. Both PASI and BSA have limited capability in differentiating acceptable symptom state in psoriasis.

Factors affecting patient-acceptable symptom states and treatment decision in familial Mediterranean fever.

Familial Mediterranean fever [FMF] is the most common autoinflammatory disease characterized by inflammatory attacks of fever and polyserositis. Patients' quality of life is significantly affected due to recurrent excruciating pain attacks and complications. This study is performed to evaluate the parameters most affecting patients' satisfaction from treatment. : Three hundred and forty-six consecutive patients diagnosed with FMF were enrolled in this study. Current treatment, acute phase proteins, number, type, and severity of predominant attacks, absenteeism from work/school in the last three months were recorded, and the participants were asked whether they needed additional treatment to evaluate Patient Acceptable Symptom State (PASS) status. Mean age of the overall group was 38.2 ± 11.7 years (62.4% female, 37.6% male). Two hundred and twenty-seven patients were treated with colchicine, 97 patients with colchicine plus Interleukin-1 (IL-1) antagonist, and 22 only with IL-1 antagonist (67.1%, 26.3%, 6.64% in order). Of the overall group, 33.8% (n = 117) believed to need additional treatment options. Additional treatment need of patients was significantly affected by work impairment due to attacks, absent days from work, disease activity, the discomfort of patients during attacks, the number of attacks, and treatment options; but not by the level of acute-phase proteins between attacks. PASS score is significantly related to clinical parameters and quality of life. Patients' PASS scores and treatment choices are notably affected by the severity and frequency of attacks and absenteeism from work/school. Clinical activity and quality of life should be evaluated at every visit to provide patients' satisfaction with treatment.

Anterior Cruciate Ligament Reconstruction Using Bone–Patellar Tendon–Bone Allograft in Patients Aged 50 and Older Leads to Improved Activity Levels and Acceptable Patient-Reported Outcomes

PurposeTo evaluate patient-reported outcomes in patients aged 50 years and older undergoing anterior cruciate ligament reconstruction (ACLR) using bone–patellar tendon–bone (BPTB) allograft with minimum 2-year follow-up.MethodsA retrospective review was performed on a consecutive series of patients aged 50 and older who underwent ACLR using BPTB allograft by a single surgeon with minimum 2-year follow-up. Postoperative International Knee Documentation Committee (IKDC), Lysholm, and Physical Component Summary of the 12-item Short-Form Health Survey were used to assess outcomes, as well as preoperative and postoperative Tegner activity scores, which were compared using a paired sample t test.ResultsFifty patients met inclusion criteria, with a mean age of 55.3 ± 4.4 years and mean follow-up of 4.8 ± 1.9 years. Tegner activity scores improved from a mean preoperative score of 3.26 to a mean postoperative score of 5.25 (P < .001). The mean postoperative scores for Lysholm, IKDC, and Physical Component Summary were 87.3, 81.1, and 54.3, respectively. In total, 36 (72%) patients achieved a patient acceptable symptom state score for IKDC and 37 (74%) patients achieved a minimal clinically important difference for Tegner activity score. Thirty-eight (76%) patients reported good-to-excellent results, 6 (12%) patients reported fair results, and 6 (12%) patients reported poor results.ConclusionsACLR with BPTB allograft in patients aged 50 and older leads to good patient-reported outcomes with significantly increased postoperative activity status at a minimum 2-year follow-up.Level of EvidenceLevel IV, therapeutic case series.

Minimal Clinically Important Difference and Patient Acceptable Symptom State in Patients With Knee Osteoarthritis Treated With PRP Injection.

Background:Although several injection-based treatments have been proposed to address knee osteoarthritis (OA), it is often difficult to understand the clinical relevance of the obtained results. The psychometric measures of minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) were developed to better interpret study findings.Purpose:To establish the MCID and the PASS for the International Knee Documentation Committee (IKDC) Subjective score and the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients treated with intra-articular platelet-rich plasma (PRP) injections for knee OA.Study Design:Case series; Level of evidence, 4.Methods:This study included 215 patients with knee OA (68% men, 32% women; age, 53.2 ± 11.3 years; body mass index, 26.8 ± 4.3 kg/m2) who underwent intra-articular PRP injections. Patients were assessed through the IKDC Subjective score and KOOS subscales, and the MCID and the PASS for both measures were independently calculated at 6 and 12 months post-injection. The MCID was calculated using the value equal to half of the standard deviation of the overall cohort improvement. The PASS was assessed using a 2-point scale (satisfied or not satisfied), with threshold values being detected through a receiver operating characteristic curve analysis and the Youden index to maximize the sensitivity and the specificity of the threshold values.Results:All scores improved significantly from baseline to 6 months and baseline to 12 months (P < .001 for all scores). All scores were stable from 6 to 12 months except for the KOOS Quality of Life subscale, which improved further (P = .033). For the IKDC, the MCID values were 8.6 and 8.5 points and the PASS scores were 59.7 and 62.1 at 6 and 12 months, respectively. Overall, the MCID and the PASS for all KOOS subscales remained constant at the 2 follow-up points. The percentage of patients who achieved the MCID and the PASS was higher than 85% at both 6 and 12 months post-injection.Conclusion:This study provided the MCID and PASS thresholds for the IKDC and KOOS scores in patients with knee OA treated with PRP injections. These psychometric measures may allow a better interpretation of the clinical relevance of injection-based treatment outcomes for knee OA.

Arthroscopic Treatment and Outcomes of Borderline Dysplasia With Acetabular Retroversion: A Matched-Control Study From the MASH Study Group

Background: Although acetabular retroversion (AR) occurs in dysplasia, management of the crossover sign (COS) or outcomes in borderline dysplasia (BD) with AR have not been reported. Purpose: To report any differences in the management of the COS in BD and nondysplastic hips and to report comparative outcomes of BD with AR with matched controls with BD or AR (ie, focal pincer femoroacetabular impingement [FAI]). Study design: Cohort study; Level of evidence, 3. Methods: A multicenter matched-pair study was performed with data from a large prospectively collected database. Inclusion criteria were patients who had undergone primary unilateral hip arthroscopy including labral repair for FAI and/or chondral pathology without significant osteoarthritis (ie, Tönnis grade 0 or 1). The study group (BD+AR) was defined radiographically by lateral center-edge angle (LCEA) on standing anteroposterior pelvis of 18° to 25° and positive COS. A 1:1:1 matching on age, sex, and body mass index was performed with a control group with BD and another control group with AR (LCEA, >25°+COS). Acetabuloplasty rates were determined for each group. Mean 2-year outcomes including the 12-Item International Hip Outcome Tool (iHOT-12), minimally clinical important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) scores were compared. Subanalysis of the study group both with and without acetabuloplasty was performed. Results: There were 69 patients, with 23 in the study group and 23 in each control group. The effect of dysplasia with or without the presence of the COS resulted in changes in acetabuloplasty rates, with 0% performed in the BD group, 35% in the BD+AR study group, and 91% in the AR group (P = .001). Arthroscopic outcomes demonstrated similar and significant mean 2-year improvement of iHOT-12 patient-reported outcomes, MCID, SCB, and PASS scores in the study and both control groups. There was a trend within the study group toward greater postoperative iHOT-12 scores in patients who received anterior-based acetabuloplasty than those who did not receive acetabuloplasty (81.7 and 70.4, respectively; P = .11). Conclusion: Acetabular coverage influences the management of the COS, with significantly lower acetabuloplasty rates in BD with AR compared with AR without BD (focal pincer impingement). Symptomatic patients with combined BD and AR had similar significant successful outcomes to those of patients with BD and those with AR (focal pincer impingement), whether treated without acetabuloplasty or, less frequently, with limited anterior-based acetabuloplasty.

Understanding the variables that are associated with failure to achieve an acceptable symptom state after reverse shoulder arthroplasty

BackgroundThe patient acceptable symptom state (PASS) was developed to improve the subjective interpretation of patient reported outcomes (PROs) and the minimum score necessary for the patient to “feel good.” The purpose of this study was to compare range of motion (ROM), final PROs, and individual responses on PROs between patients achieving or failing to meet a PASS after reverse shoulder arthroplasty (RSA). MethodsA retrospective review of multi-center prospectively maintained database of RSAs between 2015 and 2018 was conducted. Primary RSAs with minimum 2-year follow-up were included. Patients were stratified into 2 groups by whether they achieved or failed to meet PASS scores at a minimum of 2 years of 76 for the ASES score or 75.5 for the SANE score. The primary goals of the study were to compare outcomes, range of motion (ROM) and individual ASES and WOOS survey responses for patients above and below the PASS score. Results87 patients were included. Using the ASES cutoff for PASS, 33% failed to meet a PASS while 45% failed to meet a PASS defined by the SANE. The most notable difference between patients above and below ASES PASS was a significant difference in VAS pain scores (3.1 vs. 0.3; P < .001). Overall, ROM was similar between patients above and below the ASES PASS, with slight, but statistically improved rotational motion in those achieving an ASES PASS (ER(90) 14 degrees improved, P = .005, IR(90) 10 degrees improved, P = .011). Similarly, patients failing to meet the SANE PASS had twice as high VAS pain scores (1.9 vs. 0.8; P = .017). Patients failing to meet the ASES PASS had almost universally statistically higher rates of reporting “very difficult” or “unable to do” for pain, ADL and work/sports questions on the ASES and globally more symptoms on every domain of questions for the WOOS. Similarly, for the PASS defined by SANE, patients reported higher levels of pain and dysfunction on nearly every question and domain of the ASES and WOOS. ConclusionsAt least one quarter of patients do not achieve a PASS after RSA. Pain appears to be the primary driver for this finding, while ROM is very similar between patients achieving or failing to meet a PASS regardless of PRO used to define the PASS. Patients who fail to achieve PASS after RSA report doing poorly in all domains of their outcome. Level of evidenceLevel III; Retrospective Comparative Study

A prospective clinical audit to evaluate postoperative quality of recovery in adults at New Somerset Hospital, Cape Town, South Africa.

Recent developments in perioperative medicine increasingly emphasise patient-centred approaches to quality of care metrics. To this end, the 15-item Quality of Recovery (QoR-15) scale is a well-validated and widely applied patient-centred measure of perioperative service quality. To assess quality of recovery in a South African (SA) population by applying the QoR-15 and to identify the local contributors to poor quality of recovery. A prospective observational study was performed in all adults undergoing elective and emergency surgery during daytime hours over a 2-week period in February 2019 at New Somerset Hospital, Cape Town, SA. Patients were approached by a qualitative interviewer on day 1 post surgery for consented recruitment, collection of demographic information and application of the QoR-15 questionnaire. Of 193 patients who had surgery, 154 fulfilled our criteria and completed the questionnaire. The median QoR-15 score was 123 out of 150, which is classified as 'good', although most patients (35%) fell into the 'moderate' category (90 - 121); 59% achieved the patient acceptable symptom state score (≥118). The median scores of the most poorly reported QoR-15 items were 5 for 'moderate pain' and 6 for 'able to return to work or usual home activities'. Poor scoring was not related to anaesthetic modality (p=0.088), surgical discipline (p=0.237), timing of surgery (p=0.717) or obstetric as opposed to non-obstetric patients (p=0.472). Construct validity was supported by a negative correlation with duration of anaesthesia (rho=-0.286; p&lt;0.001) and lack of correlation with age (rho=-0.034; p=0.674). We found the QoR-15 to be a valid, feasible and acceptable tool for clinical auditing of perioperative service quality in SA. The median QoR-15 score was 123, with the majority of patients reflecting a moderate QoR. We have highlighted areas with potential for improvement and provided recommendations to address these aspects.

Defining the Minimal Clinically Important Difference and Patient-acceptable Symptom State Score for Disability Assessment in Surgical Patients.

The World Health Organization Disability Assessment Schedule 2.0 has been used to measure postoperative disability in several clinical trials and cohort studies. It is uncertain what the minimal clinically important difference or patient-acceptable symptom state scores are for this scale in patients recovering from surgery. The authors analyzed prospectively collected data from three studies that measured disability 3 and 6 months after surgery. Three distribution-based methods (0.3 multiplied by SD, standard error of the measurement, and 5% range) and two anchor-based methods (anchored to two patient-rated health status questions and separately to unplanned hospital readmission) were averaged to estimate the minimal clinically important difference for the World Health Organization Disability Assessment Schedule 2.0 score converted to a percentage scale. Scores consistent with a patient-acceptable symptom state and clinically significant disability were determined by an anchored 75th centile method. Data from 4,361 patients were analyzed. The average minimal clinically important difference estimate for the World Health Organization Disability Assessment Schedule 2.0 was 5%, with similar estimates in patients with or without preoperative disability. The patient-acceptable symptom state score was 16%, and the score consistent with at least moderate clinically significant disability was 35%. Using these estimates, between baseline and 6 months after surgery, 21% of patients had a significant increase in disability, and 73% achieved a patient-acceptable symptom state. A change in World Health Organization Disability Assessment Schedule 2.0 score of 5% or more after surgery is consistent with a clinically important change in disability. Patients with a score less than 16% after surgery have an acceptable symptom state and can be considered as disability-free, whereas patients with a score of 35% or more can be considered as having at least moderate clinically significant disability.

Defining Variations in Outcomes of Hip Arthroscopy for Femoroacetabular Impingement Using the 12-Item International Hip Outcome Tool (iHOT-12)

Background: As health care moves toward a value-based payment system, it will be important that patient-reported outcome measures (PROMs) define variations in outcome over a follow-up period that allows a patient to achieve maximal improvement. Although there is evidence to support the use of PROMs to assess postoperative outcomes after hip arthroscopy, there is limited information available to assess for variations in outcome at a 2-year follow-up interval. Purpose: To identify substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) cutoff scores for the 12-item International Hip Outcome Tool (iHOT-12) that define patient status across a spectrum of potential outcomes after hip arthroscopy at a 2-year follow-up interval. Study design: Cohort study (diagnosis); Level of evidence, 2. Methods: These data were collected from a research registry of patients having hip arthroscopy for femoroacetabular impingement and/or chondrolabral pathology. On initial assessment and 2 years (±2 months) postoperatively, patients completed the iHOT-12, and categorical self-rating of function. They also completed a visual analog scale of postoperative satisfaction. Receiver operator characteristic analysis was performed to determine absolute SCB iHOT-12 scores associated with an “abnormal,”“nearly normal,” or “normal” self-report of function, and PASS scores for those reporting at least 50%, at least 75%, or 100% satisfaction with their surgery. Results: Out of 723 eligible patients, 658 (91%) met the inclusion criteria. The patients consisted of 462 (70%) women and 196 (30%) men, with a mean age of 35.3 years (SD, 13 years) and mean follow-up of 722 days (SD, 69 days). Absolute SCB and PASS iHOT-12 scores ranging from 38 to 86 were accurate in identifying those who had abnormal, nearly normal, and normal self-reported function and were at least 50%, at least 75%, and 100% satisfied with surgery. The areas under the curve were >0.70, with sensitivity and specificity values ranging from 0.78 to 0.92. Conclusion: This study provides absolute SCB and PASS iHOT-12 cutoff scores that can be used to define variations in 2-year (±2 months) outcomes in patients after hip arthroscopy for femoroacetabular impingement and chondrolabral pathology. iHOT-12 scores of 38, 60, and 86 were associated with abnormal, nearly normal, and normal reports of function respectively, with scores of 60, 71, and 86 associated with at least 50%, at least 75%, and 100% satisfaction after surgery, respectively.