Final Patient-reported Outcome Research Articles

Comparison of Patient-Reported Outcomes for Immediate Unrestricted Weightbearing Versus Restricted Rehabilitation Protocols After Osteochondral Allograft Transplantation to the Distal Femur.

There is no standardized rehabilitation protocol after osteochondral allograft (OCA) transplantation surgery to the distal femur. The spectrum of recommendations includes restrictions to toe-touch weightbearing (TTWB) for 6 weeks and immediate weightbearing as tolerated (WBAT). The purpose of this study was to compare outcomes for immediate unrestricted WBAT to restricted TTWB after OCA transplantation to the distal femur. It was hypothesized that the immediate WBAT protocol would be noninferior to delayed, restricted TTWB. Retrospective cohort study. A total of 74 patients who underwent press-fit, dowel technique OCA transplantation to the femoral condyle(s) for contained (International Cartilage Repair Society grade 3-4) lesions were identified in the Metrics of Osteochondral Allograft multicenter database: 36 patients (18 women/18 men) who were prescribed TTWB were allocated to the control cohort and 38 patients (21 women/17 men) who were prescribed WBAT were allocated to the test cohort. Baseline characteristics were similar except for larger grafts in test patients (3.4 vs 2.7 cm2; P = .004) and higher body mass index (BMI) in control patients (27.8 vs 24.9 kg/m2; P = .01). Failure rates, final patient-reported outcome (PRO) scores, and PRO score changes from baseline were compared between the cohorts. Multiple regression was used to control for potential confounders and investigate noninferiority using minimal clinically important differences (MCIDs). The mean follow-up was 2 years (range, 1-5 years) in both cohorts. Both cohorts showed significant improvement in all PRO scores, with no significant between-group differences in failure rates, final PRO scores, or PRO changes from baseline. There were 3 cases of failure in each cohort (control cohort: allograft revision [n = 2], debridement [n = 1]; test cohort: chondroplasty [n = 2], conversion to total knee arthroplasty [n = 1]). Regression analysis showed that adjusted differences in final PRO scores based on weightbearing protocol were minor and less than MCIDs when controlling for age, sex, graft size, BMI, and allograft location. Analysis of the MCIDs with respect to the lower bounds of the confidence intervals indicated that WBAT was noninferior to TTWB with a reasonable degree of confidence (range, 84.1%-99.9% confidence). Results indicated that immediate unrestricted WBAT after OCA transplantation to the distal femur was equally safe and effective compared to restricted TTWB.

Association of relative resection volume with patient-reported outcomes applying different levels of oncoplastic breast conserving surgery – A retrospective cohort study

IntroductionThe American Society of Breast Surgeons (ASBrS) recently classified oncoplastic breast conserving surgery (OBCS) into two levels. The association of resection ratio during OBCS with patient-reported outcomes (PRO) is unclear. Materials and methodsPatients with stage 0-III breast cancer undergoing OBCS between 01/2011-04/2023 at a Swiss university hospital, who completed at least one postoperative BREAST-Q PRO questionnaire were identified from a prospectively maintained institutional database. Outcomes included differences in PROs between patients after ASBrS level I (<20 % of breast tissue removed) versus level II surgery (20–50 %). ResultsOf 202 eligible patients, 129 (63.9 %) underwent level I OBCS, and 73 (36.1 %) level II. Six patients (3.0 %) who underwent completion mastectomy were excluded. The median time to final PROs was 25.4 months. Patients undergoing ASBrS level II surgery were more frequently affected by delayed wound healing (p < 0.001). ASBrS level was not found to independently predict any BreastQ domain. However, delayed wound healing was shown to reduce short-term physical well-being (estimated difference −26.27, 95 % confidence interval [CI] −39.33 to −13.22, p < 0.001). Higher age was associated with improved PROs. ConclusionASBrS level II surgery allows the removal of larger tumors without impairing PROs. Preventive measures for delayed wound healing and close postoperative follow-up to promptly treat wound healing disorders may avoid short-term reductions in physical well-being.

Gene Transcription Data Are Correlated with Pain-Related Phenotypic Traits in Individuals with Sickle Cell Disease

Background: Sickle cell disease (SCD) pain is acute and chronic and associated with significant morbidity across the lifespan. Interindividual variability in SCD pain exists, despite the same hemoglobin gene defect. The biology that explains this variability is not well understood, which is a barrier to novel analgesics and disease modifying therapy. Our prior work used plasma-based gene transcription via a peripheral blood mononuclear cell (PBMC) reporter assay to identify differentially expressed transcripts between individuals with SCD and healthy Black controls. In this study, we sought to provide clinical meaning to gene transcription data in the context of SCD pain. We hypothesized that we could identify gene modules using Weighted Gene Co-expression Network Analysis (WGCNA) that are significantly associated with pain-related phenotypic traits in individuals with SCD. Methods: We leveraged our prior data from 149 individuals with SCD (median age 13.6, IQR 9.3-17.1) during baseline health and 45 healthy Black controls to discover differentially expressed transcripts between the two groups. Using our well-developed assay, PBMCs from a healthy blood donor functioned as reporter cells to plasma-born factors present in individuals with SCD during baseline health and controls. Gene expression in PBMCs was measured with Affymetrix array. Using our pre-defined filtering criteria of retaining transcripts differentially expressed between individuals with SCD and controls that exhibit a fold change &amp;gt;1.4, ANOVA p-value of &amp;lt;0.05 and an FDR &amp;lt;10%, we identified 3028 genes differentially expressed between individuals with SCD and controls. We then applied this gene list to an independent cohort of newly recruited individuals with SCD during baseline health. Plasma-based transcription using our PBMC reporter cell assay was conducted in the new independent cohort using identical methods to our derivation cohort. The gene list (n=3028) generated from our derivation cohort was used as the input list for WGCNA to investigate the association of gene modules with pain-related phenotypic traits in our new cohort. Clinical pain-related data included: patient-reported outcomes (PROs) (i.e., PROMIS Pain Interference, Pain Behavior, Pain Quality-Neuropathic, PedsQL Pain Impact), acute care pain visits, chronic pain phenotyping. PROs were scored as per developers' guidelines; means and final PRO scores were used as WGCNA traits. Descriptive statistics summarized clinical variables. WGCNA was used to assess the correlation of co-expressed gene modules with SCD pain-related phenotypic data. The correlation coefficient generated by WGCNA is between the module eigengene (i.e., first principal component of a principal component analysis which is representative of expression profiles of all genes within that module) and the phenotypic trait. We retained modules with significant correlations of ≥0.3 between these modules and SCD pain-related data. Database for Annotation, Visualization and Integrated Discovery (DAVID) was used to identify biological processes represented by the differentially expressed transcripts within each module. Results: A total of 87 individuals with SCD at baseline health were included in our current cohort. Mean age was 14.5 (SD 14.2) years, 51.7% were female and 70.1% had HbSS/HbSβ 0thal. Our WGCNA analyses identified 11 modules (Figure 1). Of these, 10 exhibited significant correlations with pain-related phenotypic traits that met our module inclusion criteria of ≥0.3. Modules with the highest number of significant pain-related trait correlations included: 1) pink, black, blue (4 each) and 2) lime, brown, red, turquoise (3 each). DAVID analyses of the biological processes contained within the modules significantly associated with pain-related traits are displayed in Figure 1. A strong immune-mediated component was found across the modules significantly associated with pain-related traits. Conclusions: We identified gene modules significantly associated with pain-related phenotypic data. These analyses give clinical meaning to gene expression data which is imperative for translational SCD pain research. A strong immune-mediated component was identified in the modules significantly associated with pain. The transcriptional data and pathways identified can be leveraged to investigate SCD pain biology and discover targets for novel pain therapeutics.

The DeOrio One Finger Test: Does a Patients Ability To Localize Their Pain Lead to Different Clinical and Patient Reported Outcomes Than Those That Cannot?

Category: Other Introduction/Purpose: A basic requirement during a history and physical examination, in a foot and ankle clinic, is the ability to pinpoint where a patient experiences discomfort. Infrequently, patients are unable to localize their pain and “paint” over a non- anatomic distribution or point to multiple, independent areas across the foot. The ability to diagnose and treat a problem become significantly more difficult in these circumstances. In this study, the treatment course, clinical and patient reported outcomes(PROs) of patients who can pinpoint where they feel pain and those that “paint” over a non-anatomic area are compared. We hypothesize that patients unable to pinpoint are more likely to require advanced imaging studies, additional diagnostic modalities, and also less likely to improve in PROs at conclusion of treatment. Methods: Patients who presented in a foot and ankle clinic with foot pain between August 2021 and August 2022 were prospectively enrolled in this IRB approved study. The senior author completed a questionnaire after consultation identifying the patient as “able to pinpoint location of pain” or “unable to pinpoint location of pain.” Patients were excluded if they were &lt; 18 years old, had neuropathy, or had pain as a result of a trauma (where does a trimalleolar ankle fracture hurt for example?). In cases where patients couldn’t pinpoint, they were counseled on localizing their symptoms and seen again 6 weeks later and given another chance to pinpoint. Diabetic patients had monofilament exams during presentation to control for undiagnosed neuropathy. Patients were followed for clinical outcomes, need for advanced imaging, need for additional diagnostic testing and finally PROs. All statistical analysis was conducted using GraphPad Prism(Ver 9.0, GraphPad Software, San Diego CA USA). Results: Overall, 423 patients were included (342 patients pinpointed and 91 patients did not). Patients unable to pinpoint were more likely to smoke (odds ratio=1.46) and to be diabetic (odds ratio=3.0). Patients with rheumatoid arthritis were more likely to be able to pinpoint(odds ratio=0.82) Patients unable to pinpoint presented with lower initial PROMIS Physical Function (40.0 vs. 43.3, p&lt; 0.01) and increased Pain Interference (56.3 vs. 53.3, p&lt; 0.01) and Depression (50.4 vs. 43.3, p&lt; 0.01) then those that could localize. These patients were more likely to require advanced imaging (p=0.039) and diagnostic testing(EMG/image-guided injection) (p=0.044). Patient reported outcomes, in addition to starting out worse at presentation, did not see the same improvements at the conclusion of treatment. See the table for a summary of the key study findings. Conclusion: The ability to localize pain during a history and physical examination has direct bearing on a patients’ treatment course and outcomes in this single center study. Patients unable to pinpoint a location have lower initial and final PROs and also require more advanced imaging and diagnostic testing. Practitioners should continue to strive to better elucidate patient symptoms in hopes of more efficiently treating these patients. However, further research is needed to truly identify whether this presenting characteristic is truly indicative of patient outcomes.

The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES): Final patient-reported outcomes at 24 months.

To report health-related patient-reported outcomes (PROs) in people with type 2 diabetes (T2D) initiating their first injectable glucose-lowering medication (GLM) with two commonly prescribed glucagon-like peptide-1 receptor agonists (GLP-1RAs) from the prospective, observational TROPHIES study (The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients). TROPHIES was a two-cohort, 24-month study conducted in France, Germany and Italy. Adults with a T2D diagnosis, naïve to injectable treatment for T2D and prescribed dulaglutide or liraglutide as their first injectable GLM, were eligible for inclusion. Study objectives included describing the following PROs associated with the treatment of T2D with GLP-1RAs: health-related quality of life; impact of weight on self-perception; life and work productivity; and patient satisfaction with treatment and injection device. Additional analyses formally compared PRO measures between the treatment cohorts. Overall, improvements from baseline in PRO scores were observed among people who started dulaglutide or liraglutide. A more pronounced trend of improvement was observed in the dulaglutide cohort for changes from baseline in treatment satisfaction and impact of weight on self-perception, supported by statistically significant differences between treatment cohorts in additional comparative analyses at 12, 18 and 24 months. More positive patient perceptions of the injection device were observed with dulaglutide than with liraglutide. Improvements in PROs observed in TROPHIES, which were more evident with dulaglutide than liraglutide, reflect a relevant clinical benefit. From the patients' perspective, satisfaction, and confidence in continuing treatment with GLP-1RAs is likely to contribute to long-term treatment persistence.

Image-free handheld robotic-assisted technology improved the accuracy of implant positioning compared to conventional instrumentation in patients undergoing simultaneous bilateral total knee arthroplasty, without additional benefits in improvement of clinical outcomes

PurposeThe purpose of this study was to compare the clinical and radiological outcomes in patients who underwent simultaneous bilateral total knee arthroplasty (SB-TKA) using either robotic-assisted TKA (RA-TKA) or conventional TKA (C-TKA).MethodsIncluded were the patients who underwent SB-TKA between January 2018 and January 2020 and had a minimum follow-up of 2 years. Of 151 patients included, 117 patients were operated using an image-free handheld robotic sculpting system (RA-TKA group) and 34 patients operated using conventional instrumentation (C-TKA group). The key outcomes noted were multiple patient-reported outcomes (PROs), adverse events, and radiological outcomes. Two investigators independently measured the radiological outcomes on pre- and post-operative radiographs in coronal plane (medial proximal tibial angle [MPTA] and anatomic lateral distal femoral angle [aLDFA]) and sagittal plane (posterior tibial slope [PTS] and posterior condylar offset [PCO]). The chi-square test was used to examine categorical variables. Student’s t test was used to analyze the continuous variables.ResultsPatients in both groups were similar in baseline characteristics (gender, body mass index, incidence of comorbidities, and length of hospital stay) except that RA-TKA group patients younger (66.7 ± 8.9 vs 70.4 ± 10.5, P = 0.037) than C-TKA group. The operative time was longer in RA-TKA group as compared to C-TKA (189.3 ± 37.1 vs 175.0 ± 28.2, P = 0.040). The final PROs at each were similar between the two groups (P > 0.05). The values of PROs at final follow-up in RA-TKA compared to C-TKA were VAS pain (0.4 ± 0.9 vs 0.4 ± 0.5), KOOS-JR (89.3 ± 5.8 vs 87.1 ± 5.3), and physical (55.9 ± 2.8 vs 55.4 ± 3.2), mental (61.1 ± 4.4 vs 60.2 ± 4.7) component of VR-12 scores, and KSS satisfaction (37.5 ± 1.1 vs 37.1 ± 2.2) (all P > 0.50 or non-significant [n.s.]). While one patient in RA-TKA required revision of femoral component for peri-prosthetic fracture, none of the patient in conventional group were revised (0.85% vs 0%, P = n.s.). The proportion of patients with outliers in RA-TKA group was lower for aLDFA (2.6% vs 22.1%, P < 0.01) and PTS (0% vs 35%, P < 0.01).ConclusionThis comparative study in patients undergoing SB-TKA found reduction of outliers in femoral and tibial implant positioning with RA-TKA as compared to C-TKA. There were no differences in both groups for pain, function, and satisfaction at a minimum of 2 years of follow-up.Level of evidenceIII Therapeutic Study.

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy

BackgroundWomen with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute’s measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin.MethodsA two-phase, sequential multi-methods approach was applied. In phase one, a comprehensive literature search was done to map the toxicity of the applied chemotherapeutics and phase III clinical studies. Phase two, which comprised selecting the PRO-CTCAE items, included discussions with and feedback from a patient advisory board, an additional literature search, and focus group interviews with senior oncologists and specialized oncology nurses. A national expert panel facilitated both phases in terms of carefully select items from the PRO-CTCAE library.ResultsPhase one identified 18 symptoms and phase two, three additional ones, leading to the inclusion of 21 PRO-CTCAE symptoms in the final PRO tool. Since PRO-CTCAE also contains one to three sub-questions on the frequency, severity, and interference with daily activities of symptoms, there were 44 potential items.ConclusionsThis study describes taking a multi-method approach to selecting items from the PRO-CTCAE library for use in a population of women with endometrial or ovarian cancer undergoing chemotherapy. By systematically combining diverse approaches, we carefully selected 21 clinically relevant symptoms covered by 44 items in the PRO-CTCAE library. Future studies should investigate the psychometric properties of this PRO tool for women with endometrial or ovarian cancer.

Telemedical Interdisciplinary Care Team Evaluation and Treatment of People With Low Back Pain: A Retrospective Observational Study

ObjectiveTo evaluate the effects of an interdisciplinary care team (ICT) model delivered by telemedicine on patients with low back pain (LBP). DesignRetrospective analysis of deidentified pre-existing data. SettingRetrospective observational study of patients presenting with LBP to a nationwide telemedicine practice using an ICT model. ParticipantsOver a 9-month period all patients with a diagnosis related to LBP and who had an ICT evaluation (medical doctor, advanced practice provider, health coach, and physical therapist) were included in the study (n=36). A minimum of 2 follow-up physical therapy visits were required for inclusion. InterventionsPatients were evaluated for LBP, received a diagnosis, and were offered a multidisciplinary treatment plan. Additional real-time audio visual medical, health coaching, registered dietician, and physical therapy services were received as deemed clinically appropriate. Main Outcome MeasuresBaseline, 30 day, and final pain (mean 81 day) measurements via numerical pain rating scale (NPRS). Baseline and final Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Mental/Physical domains. Secondary Outcome MeasuresUse of prescription medication, referral for imaging, need for injections, or surgery. Results36 patients met criteria. Pain levels included mild (n=6, 16.7%), moderate (n=19, 52.8%), and severe (n=11, 30.6%). Clinically significant pain improvements were noted in 83.3% (n=25) of those with moderate or severe pain. PROMIS Mental and Physical Health categorization from Fair/Poor to Good/Excellent significantly improved over time. The initial 20% (n=7) in Fair/Poor Mental Health improved to 6.3% (n=2) at finish, while the 80% (n=28) in Good/Excellent Mental Health at start improved to 93.8% (n=30) at finish. Regarding Physical Health, 51.4% (n=18) rated Fair/Poor at start and 31.3% (n=10) at finish, while the 48.6% (n=17) rated Good/Excellent at start improved to 68.8% (n=22) at finish. The need for prescription medication was low (n=6, 16.7%) and spinal imaging orders were negligible (n=1, 2.8%). Injections were warranted in 11.4% (n=4) of patients and surgical referral with operative treatment in 2.8% (n=1). ConclusionInterdisciplinary care delivered through telemedicine can significantly improve pain and support improved health-related quality of life in patients with LBP, with low rates of imaging, prescription, and interventional use.

Humeral osteophyte size and clinical outcomes after anatomic total shoulder arthroplasty

BackgroundThe severity of primary glenohumeral osteoarthritis (PGOA) has been associated with advanced radiographic findings including inferior humeral head osteophytes. The primary objective of this study is to analyze for any correlation between the size of the inferior humeral head osteophyte and functional outcomes in patients undergoing anatomic total shoulder arthroplasty (TSA) for PGOA. MethodsA retrospective review of a multi-surgeon database was performed to identify all patients with PGOA from 2015 to 2019 with a minimum of two-year clinical follow-up. Preoperative anteroposterior and Grashey views were used for all included patients to obtain measurements of the inferior humeral osteophyte. Two groups at the extremes of osteophyte width were identified: 1) patients with absent or minimal osteophytes (lowest quartile of width, < 4.9 mm) and those with large osteophytes (highest quartile of width, > 10.1 mm). Change in active range of motion (ROM) from baseline, patient-reported outcomes (PROs), strength and complications were assessed at a minimum of 2 years postoperatively and compared between the two groups. ResultsDemographics were similar for the large osteophyte group (n = 57) and small osteophyte group (n = 56). There was a higher percentage of patients with more significant glenoid deformity in the large osteophyte group compared to the small osteophyte group (P = .009 for A1 deltoid). The large osteophyte group had significantly more restricted preoperative ROM for all measures (P < .05 for all). There were no significant differences in final ROM achieved between the two groups. Patients in the large osteophyte group had greater improvement from baseline for external rotation at the side (31° vs 21°, P = .015), external rotation at 90° abduction (38° vs 20°, P = .004), and internal rotation at 90° abduction (30° vs 12°, P < .001) compared to the small osteophyte group. Overall, there were very few differences between the small and large osteophyte groups in final PROs, with the exception of a higher American Shoulder and Elbow Surgeons score in the large osteophyte group (90.8 vs 85.9, P = .048). ConclusionPatients with large humeral osteophytes have significantly greater restrictions in preoperative ROM compared to patients with small osteophytes. Patients with large osteophytes experience greater improvements in rotational motion after anatomic TSA compared to patients with small osteophytes, although the final ROM achieved was similar between groups. Overall, PROs after anatomic TSA were similar between patients with small and large osteophytes preoperatively.

Does the Number of Preoperative Corticosteroid Injections Affect Clinical and Radiographic Outcomes of Trapeziectomy and Suspensionplasty?

This study aimed to determine whether an increasing number of preoperative corticosteroid injections is associated with greater radiographic subsidence of the thumb metacarpal at long-term follow-up after abductor pollicis longus suspensionplasty, secondary to steroid-induced pathologic weakening of capsuloligamentous restraints surrounding the thumb carpometacarpophalangeal joint and greater extension of the lunate, but neither affect patient-reported outcomes nor revision rates. A retrospective chart review was performed of patients who underwent primary trapeziectomy and abductor pollicis longus suspensionplasty by a single surgeon over a 10-year period. The number of preoperative corticosteroid injections in the trapeziometacarpal joint was documented, and patients were separated into 4 subgroups: 0, 1, 2, or 3 or more injections. Preoperative and final radiographs were evaluated for a change in the distance between the base of the thumb metacarpal and the distal pole of the scaphoid as a measure of thumb metacarpal subsidence and radiolunate angle as a measure of nondissociative carpal instability, which has been reported as a complication after basal joint arthroplasty. Additionally, the final patient-reported outcomes (Quick Disabilities of the Arm, Shoulder, and Hand and Patient-Rated Wrist Evaluation) and revision rates were also assessed. Of a total of 60 patients with an average age of 64 years that were included in the study, 16 (26.7%) received 0, 19 (31.7%) received 1, 12 (20%) received 2, and 13 (21.7%) received 3+ preoperative injections. The median postoperative follow-up was 92 months. The mean distance between the base of the thumb metacarpal and the distal pole of the scaphoid decreased by 2 mm, and the mean radiolunate angle increased by 4° across the entire cohort. When comparing subgroups, no differences were observed in either parameter or the final Patient-Rated Wrist Evaluation and Quick Disabilities of the Arm, Shoulder, and Hand scores. This study demonstrates no apparent detrimental effect of an increased number of preoperative corticosteroid injections on radiographic thumb metacarpal subsidence, increase in extension of radiolunate angle (nondissociative carpal instability), patient-reported outcomes, or revision rates at an average of almost 8 years after trapeziectomy and abductor pollicis longus suspensionplasty. Therapeutic IV.

Primary Repair of Chronic Distal Biceps Tendon Tears.

This study reports the clinical results following primary repair of distal biceps tendon ruptures more 6 weeks after injury. A retrospective review of distal biceps tendon repairs performed by 8 different hand surgeons from January 1, 2015 to October 15, 2020 was performed. Patients with complete tears surgically treated ≥6 weeks after injury without tendon graft were included. Thirty patients qualified and underwent chart review for complication and range of motion (ROM) data. They were contacted for final patient-reported outcome measures (PROMs) using Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) and Patient Reported Elbow Evaluation (PREE) scores. Final PROMs were obtained from 21 patients with an average follow-up of 31.3 months (range: 4-71 months). Average time from injury to repair was 71 days (range: 42-204). The average QuickDASH score was 6.6 (±6.2) and PREE score was 7.8 (±8.0). The amount of elbow flexion necessary to complete the repair was documented in 21 patients and averaged 64º (±10º). Postoperatively, patients achieved an average extension/flexion of 1º (±1º) to 138º (±2º) and pronation/supination of 76º (±4º) to 77º (±3º). Complications were reported in 14 patients (47%) and included 2 re-ruptures, 1 adhesive scar formation, 1 superficial infection, 1 intraoperative lateral antebrachial cutaneous nerve laceration, 12 neuropraxias, and 1 case of heterotopic ossification (HO). Primary repair of chronic distal biceps tendon tears greater than 6 weeks from injury demonstrated excellent PROMs and elbow ROM. However, the complication rate may be higher than early repair.

738-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Patient-Reported Outcomes

Data on patient-reported outcome (PRO) measures in people living with T2D who initiate injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) medication in routine clinical practice are limited. Here we present final PRO data from the TROPHIES 24-month, prospective, non-comparative, observational study of adult patients with T2D in France, Germany and Italy who started their first injectable GLP-1 RA with either once-weekly dulaglutide (DU) or once-daily liraglutide (LIRA) . Patients’ scores on PRO questionnaires were assessed every 6 months. We present scores at 24 months compared with baseline values before starting DU or LIRA treatment. For each PRO measure, higher scores reflect better outcomes. Baseline characteristics (previously published) for patients prescribed DU (N=1,014) or LIRA (N=991) were similar between groups. Mean changes from baseline to 24 months in PRO scores indicate improvements in health outcomes in patients initiating DU or LIRA (Table) . In summary, among those patients still evaluable at 24 months we observed improvements in PRO scores from baseline in both groups, but with a more pronounced trend of improvement in the DU cohort for EQ-5D-5L VAS, IW-SP, DTSQs total, and DPM life and work productivity scores. Disclosure M.Fuechtenbusch: Advisory Panel; Berlin-Chemie AG, Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Speaker's Bureau; AstraZeneca, Novo Nordisk. K.Boye: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. B.Guerci: Advisory Panel; Amgen Inc., Medtronic, Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. L.Garcia-perez: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. E.Heitmann: None. J.Lebrec: Consultant; Eli Lilly and Company. A.Barrett: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Dib: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. M.Orsini federici: Employee; Eli Lilly and Company.

The impact of severity of patellofemoral osteoarthritis on the patient-reported outcomes of total knee arthroplasty with patellar retention: A retrospective comparative study.

The aim of this study was to investigate the impact of preoperative patellofemoral osteoarthritis severity on the final patient-reported outcomes in patients with primary osteoarthritis who underwent total knee arthroplasty with patellar retention. In this retrospective study, 167 patients (42 males, 125 females; mean age: 67.9 (range, 50-82) years), who underwent total knee arthroplasty with patellar retention due to primary osteoarthritis were included. The preoperative severity of patellofemoral osteoarthritis was classified according to the Iwano classification system. All the patients were then divided into two groups based on the severity of patellofemoral osteoarthritis: Group I, 73 patients (17 males, 56 females; mean age: 68.4 (range, 50-80) years) with mild osteoarthritis (stage 0-I) and group II, 94 patients (25 males, 69 females; mean age: 67.7 (range, 54-82) years) with moderate to severe osteoarthritis (stage II to IV). The mean follow-up was 42.8 (range, 24-59) months in group I and 41.7 (range, 24-63) months in group II. Clinical outcomes were assessed using the Oxford Knee Score, the New Knee Society Score-function score, and the Kujala score preoperatively and at the final follow-up. Also, the Forgotten Joint Score was performed at the final follow-up. The Oxford Knee Score improved from 22.5 (range, 18-26) preoperatively to 36.5 (range, 30-43) for Group I and from 21.9 (range, 16-25) preoperatively to 35.9 (range, 29-43) for Group II (P < 0.001). The Kujala score increased from 51.2 (range, 45- 65) preoperatively to 79.3 (range, 71-88) for Group I and from 50.3 (range, 42-60) preoperatively to 80.2 (range, 71-86) for Group II (P < 0.001). The New Knee Society Score-function score raised from 60.2 (range, 50-72) preoperatively to 82.2 (range, 72- 90) for Group I and from 59.5 (range, 48-69) preoperatively to 81.4 (range, 73-90) for Group II (P < 0.001). The Forgotten Joint Score was 69.9 (range, 63-76) in Group I and 70.2 (range, 62-77) in Group II (P = 0.49). Evidence from this study has shown that the preoperative severity of patellofemoral osteoarthritis has no significant impact on the final patient-reported outcomes of patients with primary osteoarthritis after patellar retention total knee arthroplasty. Level III, Therapeutic Study.

The Effect of Breast Cancer Subtype on Symptom Improvement Following Palliative Radiotherapy for Bone Metastases

AimTo assess the relationship between breast cancer subtypes and patient-reported outcomes (PRO) following palliative radiotherapy for bone metastases. Materials and methodsProspectively collected PRO for all breast cancer patients treated with palliative, bone metastasis-directed radiotherapy from 2013 to 2016 in the province of British Columbia were analysed. The PRO questionnaire scored pain severity, level of function and symptom frustration at baseline and at 3–4 weeks following palliative radiotherapy using a 12-point scale. The primary outcome was the rate of overall response (any improvement in score); the secondary outcome was the rate of complete improvement in PRO (final PRO score of 0). Multivariate logistic analysis was used to compare response rates between molecular subgroup approximations of luminal A (LumA), luminal B (LumB), HER2-enriched (HER2) and triple negative (TN), as defined by grade and immunohistochemical staining. ResultsThere were 376 patients who underwent 464 courses of palliative radiation for bone metastases. Subtypes included: 243 LumA, 146 LumB, 46 HER2 and 29 TN. There were 216 multifraction radiotherapy courses (median dose 20 Gy) and 248 single-fraction radiotherapy courses (median dose 8 Gy). The overall response rate was 85% and the complete response rate was 25%. In comparison with LumA breast cancers, TN breast cancers were associated with a lower rate of overall response (69% versus 86%, P = 0.021) and a lower rate of complete response (10% versus 28.8%, P = 0.045) on multivariate analyses. ConclusionPatients with TN breast cancer have lower rates of pain, function and symptom frustration improvement following palliative radiation for bone metastases.

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

271. Surgical technique and patient-reported outcomes in adult isthmic spondylolisthesis

BACKGROUND CONTEXT Combined anterior lumbar interbody fusion (ALIF) with posterior lumbar decompression and fusion (PLDF), and transforaminal lumbar interbody fusion (TLIF) are two procedures recommended to improve clinical outcomes in adult patients with isthmic spondylolisthesis. However, there is debate whether TLIF provides superior clinical outcomes to ALIF combined with PLDF, specifically regarding patient-reported outcome measures (PROMs). PURPOSE The purpose of this study was to compare PROMs between combined ALIF-PLDF and TLIF techniques following lumbar spinal fusion for adult isthmic spondylolisthesis. STUDY DESIGN/SETTING This study was a retrospective analysis of prospectively collected data from a single, high-volume academic medical center. PATIENT SAMPLE Patients who underwent lumbar fusion for isthmic spondylolisthesis from 2014 to 2019 were included in the analysis. Surgery was indicated after failure of conservative treatment to address radiculopathy and/or neurogenic claudication. OUTCOME MEASURES Patient-reported outcome measures were collected at preoperative and postoperative clinical visits. Metrics recorded include the visual analog scale for back pain (VAS back) and leg pain (VAS leg), the Short-Form 12 Mental Component Score (MCS-12) and Physical Component Score (PCS-12), and the Oswestry Disability Index (ODI). Secondary measures included estimated blood loss (EBL) and hospital length of stay (LOS). METHODS Patient and surgical characteristics including age, gender, body mass index (BMI), Charlson Comorbidity Index (CCI), number of levels decompressed and number of levels fused were recorded. Preoperative and final patient-reported outcome measures were obtained from an institutional query. For analysis, patients were divided into two groups based on surgical technique: combined anterior fusion with posterior stabilization (ALIF-PLDF) or anterior and posterior fusion through a posterior approach (TLIF). Multivariate linear regression was performed to correlate surgical approach and PROMs. RESULTS A total of 125 patients were included in final analysis, with 62 patients in the ALIF-PLDF group and 63 patients in the TLIF group. Patients undergoing ALIF-PLDF were more likely to be older (p=0.041) and have shorter LOS (p=0.009), while patients in the TLIF group had significantly more smoking history (p=0.007), more comorbid conditions (p=0.003), and higher number of levels decompressed (p=0.003). Patients in both the ALIF-PLDF group and the TLIF group had significant improvements in VAS back scores (p CONCLUSIONS Our results indicate that patients with isthmic spondylolisthesis treated with ALIF-PLDF approaches show significant improvements in all evaluated PROMs from initial preoperative visit to final follow-up, whereas similar patients treated with a TLIF approach have significant improvements in all PROMs except MCS-12. Our data further suggest that TLIF is more likely to be chosen for older, chronically ill patients, and those undergoing decompression at a higher number of levels. Despite these baseline differences, PROMs are similar between both fusion methods. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

The Michigan Retinal Degeneration Questionnaire: A Patient-Reported Outcome Instrument for Inherited Retinal Degenerations

To create a psychometrically validated patient-reported outcome measure for inherited retinal degenerations. Qualitative and quantitative patient-reported outcome (PROs) questionnaire development using item response theory validation. One hundred twenty-eight patients with a diagnosis of an inherited retinal degeneration at the Kellogg Eye Center (University of Michigan) were recruited and administered a 166-item questionnaire comprising 7 expert-defined domains. The questionnaire was re-administered 4-16days later to a subset of 25 participants to assess test-retest variability. Graded response models were fit by Cai's Metropolis-Hastings Robbins-Monro algorithm using the R (version 3.6.3) package mirt. Model data were fit to assess questionnaire dimensionality, to estimate item information, and to score participants. Poorly functioning items were removed, and the model was refit to create the final questionnaire. The psychometrically validated PROs measure was reduced to a 59-item questionnaire measuring 7 unidimesnional domains: central vision, color vision, contrast sensitivity, scotopic function, photopic peripheral vision, mesopic peripheral vision, and photosensitivity. A total of 39 items were removed because of poor factor loading, low item information, poor person-ability differentiation, or high item-level interdependence. This novel questionnaire produces a reliable domain score for person ability that does not show significant test-retest variability across repeated administration. The final PRO questionnaire, known as the Michigan Retinal Degeneration Questionnaire, is psychometrically validated and available for use in the evaluation of patients with inherited retinal degenerations.

Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure

PurposeHeart failure (HF) is a common condition that places considerable burden on patients. We aimed to develop a patient-reported outcome (PRO) measure to assess the symptoms and impacts of HF.MethodsPhase 1: a targeted literature review, expert interviews, and concept elicitation (CE) interviews with patients with HF (n = 26) were used to develop a conceptual model of the core symptoms and impacts of HF. To capture these concepts, three new fit-for-purpose PRO questionnaires were constructed in accordance with US Food and Drug Administration PRO guidance. Phase 2: three ‘waves’ of cognitive interviews were conducted with patients with HF (n = 28) to validate and refine the questionnaires.ResultsThree key symptoms—shortness of breath, oedema, and fatigue—were identified across the literature review, expert interviews and CE interviews. Several additional symptoms, cognitive changes and impacts of HF were reported in the CE interviews and included in the conceptual model. A 10-item symptom questionnaire (Heart Failure-Daily Symptom Diary) was constructed; cognitive testing showed that the final PRO measure was easy to understand/complete and relevant to patients with HF, confirming content validity. Two HF impact questionnaires were developed (Assessing Dyspnoea’s Impact on Mobility and Sleep and Heart Failure-Functional Status Assessment), but required refinement to ensure patient understanding.ConclusionsPatient input contributed to the development of a PRO instrument for assessing physical and cognitive symptoms important to patients with HF using novel measurement strategies. Inclusion of daily metrics offers differentiation from other qualified instruments and may provide clinical insight for improving lifestyles. Additionally, two draft PRO measures may, after further validation, be useful to assess the impacts of HF.

The Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Patients With Low Back Pain: A Randomized Control Trial

ObjectiveTo investigate the immediate changes in resting and contracted thickness of the transversus abdominis (TrA) muscle after application of thrust joint manipulation (TJM) vs sham manipulation in participants with low back pain. MethodsA pretest–posttest randomized controlled trial design was performed. Consecutive subjects satisfying eligibility criteria completed patient-report outcome baseline measures, pretreatment rehabilitative ultrasound imaging (RUSI) measurements, followed by the randomly assigned intervention then, post-treatment RUSI measurements, and post-treatment & final patient-reported outcome measures. To compare the outcomes of TJM and sham manipulation on the TrA muscle thickness, a 2-by-2 analysis of variance (treatment [TJM and sham manipulation]) by time (pretreatment and post-treatment) was completed for both the TrA muscle thickness at rest and muscle thickness during contraction. Descriptive statistics including independent-sample t tests for continuous variables and χ2 tests for categorical variables were used to analyze differences in patient-reported outcome measures between groups. ResultsSixty-seven eligible participants agreed to participate. No significant interactions were identified for either muscle thickness at rest or contraction. ConclusionThis study did not support the hypothesis that manipulation would result in greater changes in TrA thickness at rest or during contraction in participants with low back pain. Based on prior research that identified subgroups of participants likely to respond to manipulation, future research should include participants more likely to respond favorably to TJM. This study was a priori registered with clinicaltrails.gov (NCT02558855).

Functional and radiological outcome of distal radius fractures stabilized by volar-locking plate with a minimum follow-up of 1year.

Distal radius fractures (DRF) are the most common fractures of the upper extremities and incidence is expected to continue rising as life expectancy increases. Palmar locking plate stabilizing has since become the standard treatment for dorsally displaced DRF. Main aim of this study was to investigate correlation between radiological and clinical outcome in patients stabilized by palmar locking plate with a minimum follow-up of one year. A total of 524 patients with DRF, stabilized using palmar angular stable locking plate fixation were included in the study. Of these, 117 patients had to be excluded and another 177 were not accessible. The study group thus compromised 230 patients who returned for the follow-up investigation and were followed-up clinically and radiologically with a mean follow-up interval of 20months. Outcome was evaluated using pain, range of motion (ROM) and grip strength parameters. In addition, self-assessment by patients was registered on the QuickDASH, PRWE and Mayo Score. The immediate postoperative and final checkup radiographs were scrutinized for alignment and intra-articular step-off. Bivariant correlation analysis showed a significant correlation between ulnar variance and QuickDASH (r = 0.18, p = 0.01), grip strength (r = -0.18, p = 0.04) and Mayo Score (r = -0.23, p = 0.001). No significant differences could be found between an unacceptable (> 2mm) and acceptable (< 2mm) ulnar variance in respect of pain, ROM, grip strength and patient-reported outcome measurements. Age, gender, additional fracture to the ulnar styloid, or type of postoperative immobilization showed no significant or clinical important impact on the final patient-reported outcome. No significant differences in incidence of complications, ROM or loss of reduction could be found in any patients over or under 65years of age. Stabilization of DRF by palmar angular stable locking plate is a safe form of treatment and results in a good clinical and radiological outcome with low complication rate. Ulnar variance showed a significant correlation to grip strength, QuickDASH and Mayo Score, but an unacceptable ulnar variance (> 2mm) was not associated with a worse clinical important outcome. Age (< 65/> 65years), gender and type of immobilization had no impact on the complication rate or in the final functional or radiological outcome.