Differences In Patient-reported Outcome Scores Research Articles

Ultra-Low Frequency Transmitted Ultrasound Breast Imaging vs DBT (Digital Breast Tomosynthesis): A Patient-Reported Outcome Study.

Breast cancer screening remains a challenge in the United States. Many women do not get a mammogram because of pain associated with the exam, radiation exposure, false-positive results, and additional costs. Others who may benefit from annual screening do not qualify because of young age and radiation risk. We hypothesize that a novel volumetric transmitted breast ultrasound, Quantitative Transmission (QT) Scan may encourage more women to have annual breast cancer screening. Assessing results from patient-reported outcomes (PROs) may predict the value of newer, more desirable screening technologies. Pre- and post-menopausal women who qualified for breast cancer screening were enrolled in a prospective trial of Quantitative Transmission (QT Scan) vs traditional mammography via Digital Breast Tomosynthesis (DBT) Clinical Trials.gov NCT03052166. These women completed questionnaires to assess their experiences with QT Scan and DBT. Associations between QT Scan or DBT and differences in PRO scores were examined. A total of 430 subjects completed the PRO instrument analyzed. A total of 36 questions were asked, 34 were paired for both QT and DBT and two were asked regarding exclusively the QT Scan. Physical discomfort, perceptions of safety and low efficacy, false-positive results and additional out-of-pocket expenses were concerns identified as highest risk for opting out of screening mammography (differences between 2.1 and 2.9 indicate significant differences between means and standard deviations using the Cohen's d statistic). Student's T-test shows a significance level of <10 -10. Statistically significant differences in PROs between QT Scan and DBT were observed by 14 of the 17 paired experience questions (p<0.001). Significant differences in PROs were found between QT scan and DBT, indicating women have significantly more negative experiences with traditional mammography via DBT and are less inclined to undergo screening mammography. Identification of PRO differences could be used to help identify a more desirable breast cancer screening modality.

Functional and Symptomatic Improvements Based on the Femoral Tunnel Drilling Technique in Anterior Cruciate Ligament (ACL) Reconstruction.

The current literature comparing femoral tunnel techniques often reports on short-term outcomes after anterior cruciate ligament reconstruction (ACLR), but only a few studies have analyzed long-term outcomes. In addition, many studies have compared transtibial to anteromedial portal techniques without differentiating whether rigid or flexible reaming is used, making it difficult to infer how the techniques truly compare to one another. This study aimed to detect differences in patient-reported outcome scores in those treated with three different femoral tunnel drilling techniques. This study is a prospective cohort study. Of 650 patients treated for anterior cruciate ligament (ACL) injuries with ACLR, 350 were 5+ years out from surgery. Of these patients, 111 completed patient-reported outcome surveys (PROs). The Kruskal-Wallis H test was used to detect differences between patients treated with either of the three femoral tunnel drilling techniques: transtibial (TT), anteromedial portal with rigid reaming (AMP-RR), or anteromedial portal with flexible reaming (AMP-FR). Bonferroni correction was applied to the p-values to reduce the risk of making a type 1 error. No differences were found between the three groups in demographics or postoperative PROs. However, there was a significant change between pre-surgery and post-surgery PROs. TT, when compared to AMP-RR, had a greater increase in satisfaction and greater improvement in a patient's ability to go up and down the stairs from pre-surgery to post-surgery. AMP-FR, when compared to TT, had greater improvement of the patient's knee stiffness/swelling. AMP-FR, when compared to AMP-RR, had greater improvement in knee pain during stairs and the ability to go down the stairs. No differences in return to sport, additional procedures on the affected knee (meniscal surgeries or cyclops lesion excisions), or revision surgery rates were found. Overall, postoperative PROs did not show statistically significant differences between the three femoral tunnel drilling techniques. Differences, however, were identified in the responses to specific questions on PRO surveys, which may have otherwise been overlooked. It is important to recognize the differences between TT, AMP-RR, and AMP-FR in the improvement of stair climbing and swelling/stiffness as these likely directly affect a patient's satisfaction from pre-ACLR to post-ACLR.

Clinical Results of Primary Repair Versus Reconstruction of the Anterior Cruciate Ligament: A Systematic Review and Meta-analysis of Contemporary Trials.

Primary anterior cruciate ligament (ACL) repair has gained renewed interest in select centers for patients with proximal or midsubstance ACL tears. Therefore, it is important to reassess contemporary clinical outcomes of ACL repair to determine whether a clinical benefit exists over the gold standard of ACL reconstruction (ACLR). To (1) perform a meta-analysis of comparative trials to determine whether differences in clinical outcomes and adverse events exist between ACL repair versus ACLR and (2) synthesize the midterm outcomes of available trials. Systematic review; Level of evidence, 3. The PubMed, OVID/Medline, and Cochrane databases were queried in August 2023 for prospective and retrospective clinical trials comparing ACL repair and ACLR. Data pertaining to tear location, surgical technique, adverse events, and clinical outcome measures were recorded. DerSimonian-Laird random-effects models were constructed to quantitatively evaluate the association between ACL repair/ACLR, adverse events, and clinical outcomes. A subanalysis of minimum 5-year outcomes was performed. Twelve studies (893 patients; 464 ACLR and 429 ACL repair) were included. Random-effects models demonstrated a higher relative risk (RR) of recurrent instability/clinical failure (RR = 1.64; 95% confidence interval [CI], 1.04-2.57; P = .032), revision ACLR (RR = 1.63; 95% CI, 1.03-2.59; P = .039), and hardware removal (RR = 4.94; 95% CI, 2.10-11.61; P = .0003) in patients who underwent primary ACL repair versus ACLR. The RR of reoperations and complications (knee-related) were not significantly different between groups. No significant differences were observed when comparing patient-reported outcome scores. In studies with minimum 5-year outcomes, no significant differences in adverse events or Lysholm scores were observed. In contemporary comparative trials of ACL repair versus ACLR, the RR of clinical failure, revision surgery due to ACL rerupture, and hardware removal was greater for primary ACL repair compared with ACLR. There were no observed differences in patient-reported outcome scores, reoperations, or knee-related complications between approaches. In the limited literature reporting on minimum 5-year outcomes, significant differences in adverse events or the International Knee Documentation Committee score were not observed.

Arthroscopic and open reconstruction of the posterolateral corner of the knee have equally good clinical results: first results of a prospective 12-month follow-up study

PurposeArthroscopic reconstruction techniques for higher-grade posterolateral corner (PLC) injuries (Fanelli Type B, PoLIS LI-B) have not yet been validated in clinical studies. The open reconstruction technique described by Arciero is well-established and showed good restoration of joint stability in previous studies. This study aimed to compare clinical outcomes of this established open surgery technique to a newly developed arthroscopic technique in a prospective randomized clinical trial.MethodsBetween 2019 and 2021, this study focused on chronic high-grade PLC injuries (Fanelli Type B, PoLIS LI-B). Group A consisted of patients treated with conventional open surgery following Arciero’s technique, while Group B included patients treated with Arciero’s arthroscopic technique. All cases underwent additional PCL reconstruction. After a minimum 12-month follow-up, clinical scores and objective stability assessments were compared between the groups.ResultsIn total, 26 (group A 12, group B 14) eligible patients with a mean follow-up of 14.9 ± 7.2 months were evaluated in the present study. Knee stability and patient-reported outcome scores (PROMS) were significantly improved when comparing pre- and post-operative values (p < 0.0001). No clinically relevant differences in PROMS (Lysholm: A 83.9 ± 11.4 vs. B 85.3 ± 13.8; IKDC: A 76.91 ± 12.6 vs. B 76.8 ± 15.7) were shown in both groups. Additionally, no statistically significant differences were detected between groups with respect to external rotation, range of motion and instrumental stability testing. Arthroscopic reconstruction showed significantly shorter operation time (p = 0.0109). There were no clinical failures or neurovascular complications of the surgical procedures.ConclusionBoth surgical techniques for isolated chronic PLC Fanelli Type B injuries significantly improved the knee stability, were equivalent with respect to PROMs and led to good clinical results. However, arthroscopic PLC reconstruction was associated with a shorter surgery time compared to open PLC reconstruction. Therefore, arthroscopic PLC reconstruction may be a viable option in the hands of an experienced surgeon.Level of evidenceProspective cohort study, II.

Prognostic value of the Favard classification for patients before and after reverse shoulder arthroplasty performed for rotator cuff tear arthropathy

BackgroundAlthough the Favard classification is commonly utilized by surgeons to describe the supero-inferior morphology of the glenoid when treating rotator cuff arthropathy (RCA), its utility in prognosticating patients’ clinical state before and after reverse shoulder arthroplasty (RSA) remains unproven. We assessed the prognostic value of the Favard glenoid classification on preoperative clinical state and postoperative clinical and radiographic outcomes in RSA. MethodsA prospectively collected, multicenter database for a single-platform shoulder arthroplasty system was queried for patients with RCA who underwent RSA with a minimum 2-year clinical follow-up. Differences in patient reported outcome scores (PROMs) (Simple Shoulder Test, American Shoulder and Elbow Surgeons, Shoulder Pain and Disability Index, visual analog scale pain, Shoulder Function score), combined patient-reported and clinical-input scores (Constant, University of California Los Angeles, Shoulder Arthroplasty Smart), active range of motion values (forward elevation, abduction, external rotation [ER], internal rotation [IR]), radiographic outcomes (humeral radiolucency line rates, scapular notching rate), and the incidence of postoperative complications and revision surgery were compared by glenoid deformity type per the Favard classification. Comparisons were performed to assess the ability of the Favard classification to prognosticate the preoperative, postoperative, and improved state after RSA. Results400 RSAs performed for RCA were included. Comparison of outcomes between Favard glenoid types resulted in 6 pairwise comparisons of 12 clinical outcome metrics, yielding 72 total Favard glenoid pairwise comparisons for each clinical state (preoperative, postoperative, improvement). Of the 216 possible pairwise Favard glenoid type/metric comparisons, statistical significance was only reached for 3% of the combinations (7/216). Among E0, E1, and E2 glenoids, the only statistically significant pairwise comparison identified among all three clinical states was a more favorable preoperative American Shoulder and Elbow Surgeons score for E0 vs. E2 glenoids. Preoperatively, E3 glenoids had poorer ER, IR, and Shoulder Arthroplasty Smart scores compared to E0 glenoids and poorer ER compared to E2 glenoids. Postoperatively, E3 glenoids had a poorer IR score compared to E0 glenoids and poorer ER compared to E1 glenoids. No pairwise differences in preoperative to postoperative improvement were found. There were no statistically significant pairwise differences in humeral lucency rate, scapular notching rate, complication rates, or revision rates between Favard glenoid types. ConclusionAlthough useful for describing degenerative changes to the glenohumeral joint, the Favard classification offers little prognostic information regarding patient outcomes before and after RSA aside from poorer preoperative and postoperative axial rotation in E3 glenoids. Alternative glenoid classification systems or predictive models should be considered for more precise prognoses of patients undergoing RSA for RCA.

Effect of Posterior Tibial Slope on Outcomes After Posterior Cruciate Ligament Reconstruction.

Increased posterior tibial slope (PTS) leads to a relative anterior translation of the tibia on the femur. This is thought to decrease the stress on posterior cruciate ligament (PCL) reconstruction (PCLR) grafts. The purpose of this study was to analyze the effect of PTS on knee laxity, graft failure, and patient-reported outcome (PRO) scores after PCLR without concomitant anterior cruciate ligament reconstruction (ACLR). It was hypothesized that patients with higher PTS would have less knee laxity, fewer graft failures, and better PROs compared with patients with lower PTS. Case-control study; Level of evidence, 3. All patients who underwent PCLR between 2001 and 2020 at a single institution were identified. Patients were excluded if they underwent concomitant or prior ACLR or proximal tibial osteotomy, were younger than 18 years, had <2 years of in-person clinical follow-up, and did not have documented PRO scores (Lysholm score and International Knee Documentation Committee [IKDC] score). Data were collected retrospectively from a prospectively gathered database. PTS measurements were recorded from perioperative lateral knee radiographs. A linear regression model was created to analyze PTS in relation to PRO scores. Patients with a grade 1 (1-5 mm) or higher posterior drawer were compared with those who had a negative posterior drawer. A total of 37 knees met inclusion criterion; the mean age was 30.7 years at the time of surgery. The mean clinical follow-up was 5.8 years. No significant correlation was found between either the Lysholm score or the IKDC score and the PTS. Twelve knees (32.4%) had a positive posterior drawer at final follow-up. The mean PTS in knees with a positive posterior drawer was 6.2°, whereas that for knees with a negative posterior drawer was 8.3° (P = .08). No significant differences in PRO scores were identified for knees with versus knees without a positive posterior drawer. No documented graft failures or revisions were found. No significant differences were found in PROs or graft failure rates based on PTS at a mean of 5.8 years after PCLR. Increased tibial slope trended toward being protective against a positive posterior drawer, although this did not reach statistical significance.

Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease.

To evaluate whether the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a responsive instrument in psoriatic arthritis (PsA) and whether it differentiates between axial and peripheral disease activity in PsA. Individuals with PsA initiating therapy in a longitudinal cohort study based in the United States were included. Axial PsA (axPsA), most often also associated with peripheral disease, was defined as fulfillment of the Assessment of Spondyloarthritis international Society axial spondyloarthritis classification criteria or presence of axial disease imaging features. Baseline BASDAI, individual BASDAI items, patient global assessment, patient pain, and Routine Assessment of Patient Index Data 3, and score changes following therapy initiation were descriptively reported. Standardized response means (SRMs) were calculated as the mean change divided by the SD of the change. The mean (SD) baseline BASDAI score at the time of therapy initiation was 5.0 (2.2) among those with axPsA (n = 40) and 4.8 (2.0) among those with peripheral-only disease (n = 79). There was no significant difference in patient-reported outcome scores between the groups. The mean change for BASDAI was similar among axial vs peripheral disease (-0.75 vs -0.83). SRMs were similar across axial vs peripheral disease for BASDAI (-0.37 vs -0.44) and the individual BASDAI items. BASDAI has reasonable responsiveness in PsA but does not differentiate between axPsA and peripheral PsA. (ClinicalTrials.gov: NCT03378336).

Prognostic value of the Walch classification for patients before and after shoulder arthroplasty performed for osteoarthritis with an intact rotator cuff

The Walch classification is commonly utilized by surgeons when determining the treatment of osteoarthritis (OA). However, its utility in prognosticating patient clinical state before and after TSA remains unproven. We assessed the prognostic value of the modified Walch glenoid classification on preoperative clinical state and postoperative clinical and radiographic outcomes in total shoulder arthroplasty (TSA). A prospectively-collected, multi-center database for a single-platform TSA system was queried for patients with rotator cuff-intact OA and minimum 2 year follow-up after anatomic and reverse TSA (aTSA, rTSA). Differences in patient-reported outcome scores (PROMS) [SST, ASES, SPADI, VAS Pain, Shoulder Function score], combined patient-reported and clinical-input scores (Constant, UCLA, SAS), active range of motion (ROM) values (forward elevation [FE], abduction, external rotation [ER], internal rotation [IR], and radiographic outcomes (humeral and glenoid radiolucency line rates, scapula notching rate) were stratified and compared by glenoid deformity type per the Walch classification for aTSA and rTSA cohorts. Comparisons were performed to assess the ability of the Walch classification to predict the preop, postop, and improved state after TSA. 1,008 TSAs were analyzed including 576 aTSA and 432 rTSA. Comparison of outcomes between Walch glenoid types resulted in 15 pairwise comparisons of 12 clinical outcome metrics, yielding 180 total Walch glenoid pairwise comparisons for each clinical state (preoperative, postoperative, improvement). Of the 180 possible pairwise Walch glenoid type / metric comparisons studied for aTSA and rTSA cohorts, <6% and < 2% significantly differed in aTSA and rTSA cohorts, respectively. Significant differences based on Walch type were seen after adjustment for multiple pairwise comparisons in the aTSA cohort for FE and ER preoperatively, the Constant score postoperatively, and for abduction, FE, ER, Constant score, and SAS score for pre- to postoperative improvement. In the rTSA cohort, significant differences were only seen in abduction and Constant score both postoperatively and for pre- to postoperative improvement. There were no statistically significant differences in humeral lucency rate, glenoid lucency rate (aTSA), scapular notching rate (rTSA), complication rates, or revision rates between Walch glenoid types after TSA. Although useful for describing degenerative changes to the glenohumeral joint, we demonstrate a weak association between preoperative glenoid morphology according to the Walch classification and clinical state when evaluating patients undergoing TSA for rotator cuff-intact OA. Alternative glenoid classification systems or predictive models should be considered to provide more precise prognoses for patients undergoing TSA for rotator cuff-intact OA.

Improved Yet Varied Clinical Outcomes Observed With Comparison of Arthroscopic Superior Capsular Reconstruction Versus Arthroscopy-Assisted Lower Trapezius Transfer for Patients With Irreparable Rotator Cuff Tears

To evaluate the outcomes of arthroscopic superior capsular reconstruction (SCR) and arthroscopy-assisted lower trapezius tendon transfer (LTT) for posterosuperior irreparable rotator cuff tears (IRCTs). Over an almost 6-year period (October 2015 to March 2021), all patients who underwent IRCT surgery with a minimum 12-month follow-up period were identified. For patients with a substantial active external rotation (ER) deficit or lag sign, LTT was preferentially selected. Patient-reported outcome scores included the visual analog scale (VAS) pain score, strength score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, Single Assessment Numeric Evaluation (SANE) score, and Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. We included 32 SCR patients and 72 LTT patients. Preoperatively, LTT patients had more advanced teres minor fatty infiltration (0.3 vs 1.1, P= .009), a higher global fatty infiltration index (1.5 vs 1.9, P= .035), and a higher presence of the ER lag sign (15.6% vs 48.6%, P < .001). At a mean follow-up of 2.9 ± 1.3 years (range, 1.0-6.3 years), no differences in patient-reported outcome scores were observed. Postoperatively, SCR patients had a lower VAS score (0.3 vs 1.1, P= .017), higher forward elevation (FE) (156° vs 143°, P= .004), and higher FE strength (4.8 vs 4.5, P= .005) and showed greater improvements in the VAS score (6.8 vs 5.1, P= .009), FE (56° vs 31°, P= .004), and FE strength (1.0 vs 0.4, P < .001). LTT patients showed greater improvement in ER (17° vs 29°, P= .026). There was no statistically significant between-cohort difference in complication rate (9.4% vs 12.5%, P= .645) or reoperation rate (3.1% vs 10%, P= .231). With adequate selection criteria, both SCR and LTT provided improved clinical outcomes for posterosuperior IRCTs. Additionally, SCR led to better pain relief and restoration of FE whereas LTT provided more reliable improvement in ER. Level III, treatment study with retrospective cohort comparison.

ACL reconstruction provides superior stability than ACL repair in patients with Schenck III and IV knee joint dislocations: first results of a 12 month follow-up study

PurposeAcute knee dislocation is a rare but devastating multi-ligamentous knee injury with only limited evidence-based surgical technique recommendations. The aim of this study was a comparison of two different anterior cruciate ligament (ACL) restoration techniques as part of an early total surgical care concept: (1) repair of ACL with additional internal bracing (ACLIB) compared to; (2) ACL reconstruction with autograft (ACLR).MethodsRetrospective, clinical-study of patients with an acute type III or IV knee dislocation (according to Schenck classification), in which the ACL was treated with ACLIB or ACLR within 12 days. The PCL was sutured and internally braced in all cases. Medial and lateral complex injuries were repaired and additionally laterally augmented by an Arciero reconstruction. After a minimum 12 months follow-up different patient-reported outcome measurements (IKDC, Lysholm, VAS, Tegner Score) and instrumental stability assessment by Rolimeter -test and stress radiographs (Telos™) were analyzed. Groups were compared by t test with p < 0.05 considered significant.ResultsIn total, 20 patients (5 IIIM, 5 IIIL and 10 IV) were included in this study with an average follow-up of 13.7 ± 2.6 months. There were significant differences in instrumental stability testing (side-to-side difference (SSD) of anterior tibial translation: ACLIB 2.7 ± 1.5 mm vs. ACLR 1.3 ± 1.3; p = 0.0339) and stress radiography (SSD ACL: ACLIB 3.4 ± 2.2 mm vs. ACLR 0.4 ± 2.7; p = 0.0249) between groups. ACLIB group showed greater ROM in terms of flexion (SSD Flexion: ACLIB 7.8 ± 9.9° vs. ACLR 16 ± 7.0°; p = 0.0466; Total Flexion overall 125.5 ± 11.8°). No clinically relevant differences in patient-reported outcome scores (Lysholm Score: ACLIB 82 ± 16.4 vs. ACLR 85 ± 10.4; IKDC subjective score: ACLIB 70.4 ± 17 vs. ACLR 76.6 ± 8.3) were determined.ConclusionACLR provides superior translational stability than ACLIB in terms of instrumental testing and stress radiography. Both techniques were equivalent with respect to PROMS and led to good and excellent clinical results.Level of evidenceRetrospective cohort study, III.

No difference in clinical outcomes between operative and nonoperative management of minimally retracted proximal hamstring ruptures.

The indications for surgical treatment of proximal hamstring ruptures are continuing to be refined. The purpose of this study was to compare patient-reported outcomes (PROs) between patients who underwent operative or nonoperative management of proximal hamstring ruptures. A retrospective review of the electronic medical record identified all patients who were treated for a proximal hamstring rupture at our institution from 2013 to 2020. Patients were stratified into two groups, nonoperative or operative management, which were matched in a 2:1 ratio based on demographics (age, gender, and body mass index), chronicity of the injury, tendon retraction, and number of tendons torn. All patients completed a series of PROs including the Perth Hamstring Assessment Tool (PHAT), Visual Analogue Scale for pain (VAS), and the Tegner Activity Scale. Statistical analysis was performed using multi-variable linear regression and Mann-Whitney testing to compare nonparametric groups. Fifty-four patients (mean age = 49.6 ± 12.9years; median: 49.1; range: 19-73) with proximal hamstring ruptures treated nonoperatively were successfully matched 2:1 to 27 patients who had underwent primary surgical repair. There were no differences in PROs between the nonoperative and operative cohorts (n.s.). Chronicity of the injury and older age correlated with significantly worse PROs across the entire cohort (p < 0.05). In this cohort of primarily middle-aged patients with proximal hamstring ruptures with less than three centimeters of tendon retraction, there was no difference in patient-reported outcome scores between matched cohorts of operatively and nonoperatively managed injuries. Level III.

Is Disease Response a Patient-Centered Clinical Trial Endpoint in Acute Myeloid Leukemia: Differences in Symptom Burden and Physical Function By Response Status in the Beat-AML Master Trial

Objective: To inform regulatory decision making about trial design and drug approval, we examined whether disease response status is a patient-centered endpoint in therapeutic trials for acute myeloid leukemia (AML). Specifically, we estimated the association of response status with patient-reported symptoms and physical function in the Beat-AML Master Trial. Methods: The Beat-AML Master Trial (NCT03013998) is composed of a genomic screening protocol and multiple sub-studies of biomarker-based treatments for sub-types of acute myeloid leukemia. The patient-reported outcome (PRO) assessment occurred at baseline and at specified study visits about once per cycle depending on treatment phase. The PRO assessment included the MD Anderson Symptom Inventory (MDASI) AML/MDS symptom scale (17 items), additional symptom items from the MDASI library relevant to Beat-AML therapies (10 items), and the PROMIS® Physical Function short form (6 items). The two symptom scale scores range from 0-10 where higher scores indicate greater symptom burden; the physical function scale score ranges from 0-100 where higher scores indicate better physical function. Disease response was assessed according to 2017 ELN AML Recommendations, including: complete remission (CR), complete remission without minimal residual disease (CRMRD-), complete remission with hematologic improvement (CRh), complete remission with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), partial remission (PR), stable disease, progressive disease, recurrence/relapse, and treatment failure. For this analysis, response status was identified for each PRO assessment timepoint. Linear mixed effects models estimated the differences in PRO scores between each response status and CR. The analytic sample was composed of individuals who completed the baseline PRO assessment and at least one PRO assessment post baseline. The minimally important difference (MID) for the PROMIS Physical Function scale is 4 points (Yost, J Clin Epi 2012). The symptom scales do not have established MID, so coefficients were compared to a small effect size (0.20) per Cohen's d. Results: The analytic sample included 240 patients from 11 Beat-AML sub-studies; the median age was 73 years (range: 42-90) and 42.5% were female. Median follow-up time with PRO assessments was 18.4 months. The survey response rate was 80.7%. The mean (standard deviation) PRO scale scores at baseline were: 2.11 (1.67) AML/MDS symptom scale, 1.54(1.54) additional symptoms, and 36.65(9.62) Physical Function. The proportion of patients achieving each response at any point during protocol treatment was 32.1% CR, 7.5% CRMRD-, 6.7% CRh, 23.3% CRi, 19.6% MLFS, 5.8% PR, 73.3% stable disease, 11.7% progressive disease, 20.0% recurrence/relapse, and 7.5% treatment failure, for an average of 2.4 responses per patient. After controlling for age, gender, treatment (sub-study), time since baseline, and adjusting for drop-out missingness, we found that, compared to CR, symptom burden was greater for MLFS and stable disease (coefficient range 0.33 to 0.66) (see Table 1). Symptom burden per the AML/MDS scale only was also greater for recurrence/relapse (coef. 0.49). Physical function was worse (per MID) for MLFS, stable disease, and progressive disease (coefficient range: -4.42 to -4.76). Discussion: PRO data from 11 sub-studies of the Beat AML Master Trial indicate key differences and similarities between disease response statuses in terms of symptom burden and physical function. MLFS was the only type of response that differed from CR with respect to symptom burden and physical function. Stable disease and recurrence/relapse were associated with greater symptom burden than CR, but progressive disease was not, however it was associated with worse physical function. Findings regarding treatment failure may be limited by small sample and wide range of health within that status. Sensitivity analyses will include removing rare symptoms from the symptom scales, which may increase model coefficients. Subsequent analysis will examine the association of the patient's best response status with long term physical function. Conclusion: Further research is warranted to establish the response statuses of CRMRD-, CRh, CRi, and partial remission as clinical trial endpoints that are valuable to patients with respect to health-related quality of life. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications.

BackgroundOsseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient-reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes.MethodsIn a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n ​= ​51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0–100) and the Short Form 36 Health Survey (SF-36, ten scores 0–100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan–Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spearman's correlation analysis was used for analyses of associations between adverse events.ResultsPROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (−28) and global score (+38) (all p ​< ​0.001), and the SF-36 physical functioning score (+26, p ​< ​0.001) and physical component score (+6, p ​< ​0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%–91%), 65% (CI: 49%–77%) and 17% (CI: 7%–29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2–5.1) constituted the most common serious adverse event and were more common during the last five years than during the first five years (p ​< ​0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1–0.5) vs. 0.3 per person-years (CI: 0.1–0.5) (p ​= ​0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p ​< ​0.001) and between mechanical complications and adverse events (0.65, p ​< ​0.001).ConclusionImproved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.

Outcomes of Arthroscopic Anterior Labroligamentous Periosteal Sleeve Avulsion Lesions: A Minimum 2-Year Follow-up

Background: Anterior labroligamentous periosteal sleeve avulsion (ALPSA) lesions can occur in recurrent anterior shoulder instability, which may lead to the labrum scarring medially to the glenoid. ALPSA lesions have also been associated with greater preoperative dislocations, larger Hill-Sachs lesions, and greater degrees of glenoid bone loss. Therefore, patients with these lesions have historically had a higher failure rate after repair, with nearly double the recurrent instability rate compared with those undergoing standard arthroscopic Bankart repair. Purpose: To compare minimum 2-year outcomes of arthroscopic mobilization and anatomic repair of ALPSA lesions with those after standard arthroscopic Bankart repair. Study Design: Cohort study; Level of evidence, 3. Methods: Consecutive patients who underwent arthroscopic repair of ALPSA lesions were matched in a 1-to-3 fashion to patients who underwent standard Bankart repair by age, sex, number of previous ipsilateral shoulder instability surgical procedures, and number of anchors used. Patient-reported outcome (PRO) scores were compared preoperatively and postoperatively (American Shoulder and Elbow Surgeons [ASES]; 12-Item Short Form Health Survey [SF-12] Physical Component Summary [PCS]; Single Assessment Numeric Evaluation [SANE]; shortened version of Disabilities of the Arm, Shoulder and Hand; and satisfaction). Recurrent instability, on- versus off-track Hill-Sachs lesion, and reoperation rates were analyzed. Results: A total of 100 shoulders (25 ALPSA and 75 Bankart) with an overall mean age of 25.7 years were evaluated. Patients in the ALPSA group demonstrated significant improvements in the ASES (preoperative, 74.8; postoperative, 89.7; P = .041) and SF-12 PCS (preoperative, 46.9; postoperative, 53.4; P = .021) scores but not the SANE score (preoperative, 65.2; postoperative, 75.3; P = .311). Patients in the Bankart group had significant improvements in all outcome scores at final follow-up: ASES (preoperative, 67.1; postoperative, 90.3), SANE (preoperative, 58.0; postoperative, 85.7), and SF-12 PCS (preoperative, 45.3; postoperative, 52.9) (all P < .001). There were no significant differences in PRO scores between the groups preoperatively or postoperatively (P > .05). The median satisfaction for the ALPSA group was 10 of 10 and for the Bankart group it was 9 of 10 (P = .094). There was a significantly higher rate of recurrent dislocation in the ALPSA group (8/25 [32.0%]) compared with the Bankart group (10/75 [13.3%]) (P = .040). Additionally, 5 patients (20.0%) in the ALPSA group underwent revision surgery at a mean of 5.6 years, and 8 patients (10.7%) in the Bankart group underwent revision surgery at a mean of 4.4 years (P = .311). Conclusion: Despite improvements in the recognition of and surgical techniques for ALPSA lesions, they still lead to significantly higher postoperative dislocation rates; however, no differences in PRO scores were found. These findings highlight the importance of early surgical interventions in anterior shoulder instability with the hope of lessening recurrent instability and the risk of developing an ALPSA lesion, as well as careful assessment of the quality of soft tissues and other risk factors for recurrence when considering what type of shoulder stabilization procedure to perform.

Does Retention of the Posterior Cruciate Ligament Lead to a More "Forgotten Joint" Following Total Knee Arthroplasty?

Posterior cruciate ligament (PCL) retention may impact a patient's awareness of their artificial joint following primary total knee arthroplasty (pTKA) due to increased proprioception and more native knee kinematics. Therefore, the purpose of this study was to investigate whether cruciate-retaining (CR) or posterior-stabilized (PS) implants influence the Forgotten Joint Score (FJS-12) following pTKA. We retrospectively reviewed all patients who underwent pTKA with a CR or PS implant at our institute between October 2017 and March 2021. Of the 6,258 patients identified, 5,587 did not have recorded FJS-12 scores at either three months, one year, or two years postoperatively nor a Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) preoperatively, three months, or one year postoperatively, and these were considered lost to follow up. Thus, a total of 671 cases were identified and subsequently stratified into two cohorts based on whether they received a CR (n=236, 35%) or PS (n=435, 65%) implant. Patients who received PS implants were further divided into constrained (CoN) and non-constrained (NCoN) liner cohorts. Multivariable linear regression analysis was used to compare patient-reported outcome (PRO) scores. There were no significant differences in PRO scores between CR and PS implants at any time point. Patients in the CoN (n=74) cohort had significantly higher FJS-12 scores at one year (CoN: 56.31 + 25.34 vs NCoN: 42.24 + 27.00, p=0.001) and two years (CoN: 58.52 + 33.71 vs NCoN: 46.97 + 27.44, p=0.013) postoperatively compared to patients in the NCoN (n=361) cohort. Although our analysis demonstrated significant differences in FJS-12 scores at one and two years postoperatively depending upon the liner constraint, there were no significant differences in FJS-12 scores between CR and PS implants. Therefore, while retention of the PCL does not impact patient awareness of their artificial joint, the level of liner constraint may influence outcomes if the PCL is sacrificed.

Health-Related Quality of Life in a Biologic Assignment Trial of Reduced Intensity Hematopoietic Cell Transplantation Based on Donor Availability in Patients Aged 50-75 with Advanced Myelodysplastic Syndrome

Health-Related Quality of Life in a Biologic Assignment Trial of Reduced Intensity Hematopoietic Cell Transplantation Based on Donor Availability in Patients Aged 50-75 with Advanced Myelodysplastic Syndrome

The minimal clinically important difference of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and upper extremity computer adaptive tests and QuickDASH in the setting of elbow trauma.

BackgroundMinimal clinically important difference (MCID) estimates are useful for gauging clinical relevance when interpreting changes or differences in patient-reported outcomes scores. These values are lacking in the setting of elbow trauma. Our primary purpose was to estimate the MCID of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) computer adaptive test (CAT), the PROMIS upper extremity (UE) CAT, and the QuickDASH using an anchor-based approach for patients recovering from elbow trauma and related surgeries. Secondarily, we aimed to estimate the MCID using the 1/2 standard deviation method.Materials & methodsAdult patients undergoing treatment for isolated elbow injuries between July 2014 and April 2020 were identified at a single tertiary academic medical center. Outcomes, including the PROMIS PF CAT v1.2/2.0, PROMIS UE CAT v1.2, and QuickDASH, were collected via a tablet computer. For inclusion, baseline (6 months before injury up to 11 days postoperatively or after injury) and follow-up (11 to 150 days postoperative or after injury) PF or UE CAT scores were required, as well as a response to an anchor question querying improvement in physical function. The MCID was calculated using (1) an anchor-based approach using the difference in mean score change between anchor groups reporting “No change” and “Slightly Improved/Improved” and (2) the 1/2 standard deviation method.ResultsOf the 146 included patients, the mean age was 46 ± 18 years and 67 (46%) were women. Most patients (129 of 146 or 88%) were recovering from surgery, and the remaining 12% were recovering from nonoperatively managed fractures and/or dislocations. The mean follow-up was 157 ± 192 days. Scores for each instrument improved significantly between baseline and follow-up. Anchor-based MCID values were calculated as follows: 5.7, 4.6, and 5.3 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively. MCID values estimated using the 1/2 standard deviation method were 4.3, 4.8, and 11.7 for the PROMIS PF CAT, PROMIS UE CAT, and QuickDASH, respectively.ConclusionsIn the setting of elbow trauma, we propose MCID ranges of 4.3 to 5.7 for the PROMIS PF CAT, 4.6 to 4.8 for the PROMIS UE CAT, and 5.3 to 11.7 for the QuickDASH. These values will provide a framework for clinical relevance when interpreting clinical outcomes studies, or powering clinical trials, for populations recovering from trauma.

No Correlation Between Depth of Acetabuloplasty or Postoperative Lateral Center-Edge Angle on Midterm Outcomes of Hip Arthroscopy With Acetabuloplasty and Labral Repair

Background: The treatment of pincer deformity in hip arthroscopy remains controversial, with some authors advocating that over resection may risk early joint deterioration. The role of acetabular resection depth and postoperative acetabular morphology on postoperative outcomes has yet to be defined. Purpose/Hypothesis: This study measures the influence of acetabular resection depth and postoperative lateral center-edge angle (LCEA) on minimum 5-year patient-reported outcomes (PROs), revision rates, and conversion to total hip arthroplasty using a single surgeon’s prospective database. We hypothesized that patients with acetabular resections >10°, as measured by LCEA, or patients with postoperative LCEA outside the normal range of 25° to 35° would have lower PROs, higher revision rates, and higher conversion to total hip arthroplasty at midterm follow-up. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 192 patients who underwent primary hip arthroscopy with acetabuloplasty and labral repair by a single surgeon with a minimum 5-year follow-up met the inclusion criteria. Preoperative and postoperative LCEAs were measured on supine anteroposterior radiographs, and patients were divided into cohorts based on LCEA and acetabular resection depth. Cohorts for postoperative LCEA were <20° (dysplasia), 20° to 25° (borderline dysplasia), 25° to 35° (normal), and >35° (borderline overcoverage). Cohorts for acetabular resection depth were <5°, 5° to 10°, and >10° difference from preoperative to postoperative LCEA. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 12-Item Short Form Health Survey, modified Harris Hip Score, Hip Outcome Score, satisfaction scores, revision rates, and conversion to arthroplasty rates. Results: Patients significantly improved in all outcome score measures at final follow-up. There were no statistically significant differences in PRO scores or conversion to total hip arthroplasty between any cohorts in the postoperative LCEA group. There were more revisions in the 25° to 35° cohort than the other cohorts (P = .02). The 5-10° resection depth cohort demonstrated a higher postoperative WOMAC score (P = .03), but otherwise no statistically significant differences were seen between resection depth cohorts in the remaining postoperative outcomes scores, revision rates, or conversion to total hip arthroplasty rates. Conclusion: Patients with postoperative LCEA values outside the normal reference range and with large resections perform similar to those with normal postoperative LCEA values and smaller resections at a minimum 5-year follow-up.

Preoperative Lung Function Is Associated With Patient-Reported Outcomes After Lung Cancer Surgery

Patient quality of life (QOL) is a critical outcomes measure in lung cancer surgery. Patient-reported outcomes (PROs) provide valuable insight into the patient experience and allow measurement of preoperative and postoperative QOL. Our objective was to determine which clinical factors predict differences in QOL, as measured by patient-reported physical function and pain intensity among patients undergoing minimally invasive lung cancer surgery. PRO surveys assessing physical function and pain intensity were conducted using instruments from the National Institutes of Health Patient-Reported Outcomes Measurement Information System. PRO surveys were administered to patients undergoing minimally invasive lung cancer resections at preoperative, 1-month, and 6-month postoperative time points, in an academic institution. Linear mixed-effects regression models were constructed to assess the association between clinical variables on PRO scores over time. A total of 123 patients underwent a thoracoscopic lung resection for cancer. Mean age of the cohort was 67 ± 9.6 years, 43% were male, and 80% were White. When comparing clinical variables with PRO scores after surgery, lower diffusing capacity of the lungs for carbon monoxide (Dlco) was associated with significantly worse physical function (P < .01) and greater pain intensity scores (P < .01) at 6 months, with no differences identified at 1 month. No other studied clinical factor was associated with significant differences in PRO scores. Low preoperative Dlco was associated with significant decreases in PRO after minimally invasive lung cancer surgery. Dlco may be of utility in identifying patients who experience greater decline in QOL after surgery and for guiding surgical decision making.

Do hip precautions after posterior-approach total hip arthroplasty affect dislocation rates? A systematic review of 7 studies with 6,900 patients

Background and purpose — Hip precautions limiting flexion, adduction, and internal rotation have been prescribed traditionally to minimize dislocation rates following THA. We assessed the prevalence of hip dislocation following posterior approach total hip arthroplasty without postoperative hip precautions. Methods — A systematic review of multiple medical databases was performed using the PRISMA guidelines and checklist. All clinical outcome studies that reported dislocation rates and postoperative instructions following posterior approach, primary surgery, published within the last 6 years, were included. Results — 6,900 patients were included from 7 Level I–IV studies, with 3,517 treated with and 3,383 without precautions. There was no statistically significant difference in the rates of dislocation between groups (2.2% in restricted group vs. 2.0% in unrestricted group). All but 1 study demonstrated no statistically significant differences in patient-reported outcome scores between restricted and unrestricted groups, including those pertaining to return to function, confidence, and pain. Interpretation — The review found no impact on dislocation rates following total hip arthroplasty performed through a posterior approach, regardless of the use of hip precautions. We also found no impact of the prescription of hip precautions on patient-reported outcome scores.