Patient-reported Outcomes In Patients Research Articles

Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines

BACKGROUND CONTEXTObesity is increasing. Previous studies have demonstrated an association between obesity and adverse events after lumbar fusion. There is limited evidence on the effect of obesity on minimally invasive SI joint fusion (SIJF) outcomes. PURPOSEThe purpose of this study was to investigate the impact of obesity on patient-reported outcomes in patients undergoing SIJF surgery using triangular titanium implants (TTI). STUDY DESIGNRetrospective cohort study based on four prospective clinical trials (INSITE [NCT01681004], SIFI [NCT01640353], iMIA [NCT01741025], and SALLY [NCT03122899]). PATIENT SAMPLEAdult patients ≥18 years of age who underwent minimally invasive surgery (MIS) sacroiliac joint (SIJ) fusion between 2012 and 2021. OUTCOME MEASURESVisual analog scale (VAS Pain), Oswestry Disability Index (ODI). METHODSParticipants were classified using the National Institutes of Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects underwent either minimally invasive SIJ fusion with TTI or nonsurgical management (INSITE and iMIA studies only). All subjects completed SIJ pain scale scores (measured with a 100-point VAS) and disability scores (measured with ODI) at baseline and at scheduled visits to 24 months. Repeated measures analysis of variance was used to examine the impact of BMI category on score changes. RESULTSIn the SIJF group, mean SIJ pain improved at 24 months by 53.3 points (p<.0001). Over the 24-month follow-up period, BMI category did not impact mean improvement in SIJ pain scale score (repeated measures analysis of variance (ANOVA) p=.44). In the SIJF group, mean ODI at 24 months improved by 25.8 points (p<.0001). BMI category did not impact mean improvement in ODI (ANOVA p=.60). In the nonsurgical management (NSM) group, mean improvements in SIJ pain scale and ODI were clinically small (8.7 and 5.2 points, respectively) and not affected by BMI category (ANOVA p=.49 and .40). CONCLUSIONThis study demonstrates similar benefits and risks of minimally invasive SIJ fusion with TTI across all BMI categories. This analysis suggests that obese patients benefit from minimally invasive SIJ fusion and should not be denied this procedure based solely on elevated BMI.

Patient-Reported Outcomes in Patients Undergoing Lumpectomy With and Without Defect Closure.

The effect of lumpectomy defect repair (a level 1 oncoplastic technique) on patient-reported breast satisfaction among patients undergoing lumpectomy has not yet been investigated. Patients undergoing lumpectomy at our institution between 2018 and 2020 with or without repair of their lumpectomy defect during index operation, comprised our study population. The BREAST-Q quality-of-life questionnaire was administered preoperatively, and at 6 months, 1 year, and 2 years postoperatively. Satisfaction and quality-of-life domains were compared between those who did and did not have closure of their lumpectomy defect, and compared with surgeon-reported outcomes. A total of 487 patients met eligibility criteria, 206 (42%) had their partial mastectomy defect repaired by glandular displacement. Median breast volume, as calculated from the mammogram, was smaller in patients undergoing defect closure (826 cm3 vs. 895 cm3, p = 0.006). There were no statistically significant differences in satisfaction with breasts (SABTR), physical well-being of the chest (PWB-CHEST), or psychosocial well-being (PsychWB) scores between the two cohorts at any time point. While patients undergoing defect closure had significantly higher sexual well-being (SexWB) scores compared with no closure (66 vs. 59, p = 0.021), there were no predictors of improvement in SexWB scores over time on multivariable analysis. Patients' self-reported scores positively correlated with physician-reported outcomes. Despite a larger lumpectomy-to-breast volume ratio among patients undergoing defect repair, satisfaction was equivalent among those whose defects were or were not repaired at 2 years postsurgery. Defect repair was associated with clinically relevant improvement in patient-reported sexual well-being.

Does diabetes affect outcome or reoperation rate after lumbar decompression or arthrodesis? A matched analysis of the Quality Outcomes Database data set.

Diabetes mellitus (DM) is a known risk factor for postsurgical and systemic complications after lumbar spinal surgery. Smaller studies have also demonstrated diminished improvements in patient-reported outcomes (PROs), with increased reoperation and readmission rates after lumbar surgery in patients with DM. The authors aimed to examine longer-term PROs in patients with DM undergoing lumbar decompression and/or arthrodesis for degenerative pathology. The Quality Outcomes Database was queried for patients undergoing elective lumbar decompression and/or arthrodesis for degenerative pathology. Patients were grouped into DM and non-DM groups and optimally matched in a 1:1 ratio on 31 baseline variables, including the number of operated levels. Outcomes of interest were readmissions and reoperations at 30 and 90 days after surgery in addition to improvements in Oswestry Disability Index, back pain, and leg pain scores and quality-adjusted life-years at 90 days after surgery. The matched decompression cohort comprised 7836 patients (3236 [41.3] females) with a mean age of 63.5 ± 12.6 years, and the matched arthrodesis cohort comprised 7336 patients (3907 [53.3%] females) with a mean age of 64.8 ± 10.3 years. In patients undergoing lumbar decompression, no significant differences in nonroutine discharge, length of stay (LOS), readmissions, reoperations, and PROs were observed. In patients undergoing lumbar arthrodesis, nonroutine discharge (15.7% vs 13.4%, p < 0.01), LOS (3.2 ± 2.0 vs 3.0 ± 3.5 days, p < 0.01), 30-day (6.5% vs 4.4%, p < 0.01) and 90-day (9.1% vs 7.0%, p < 0.01) readmission rates, and the 90-day reoperation rate (4.3% vs 3.2%, p = 0.01) were all significantly higher in the DM group. For DM patients undergoing lumbar arthrodesis, subgroup analyses demonstrated a significantly higher risk of poor surgical outcomes with the open approach. Patients with and without DM undergoing lumbar spinal decompression alone have comparable readmission and reoperation rates, while those undergoing arthrodesis procedures have a higher risk of poor surgical outcomes up to 90 days after surgery. Surgeons should target optimal DM control preoperatively, particularly for patients undergoing elective lumbar arthrodesis.

SAPHIR: real-world clinical research platform for molecular testing, treatment, and clinical and patient-reported outcomes in patients with gastroesophageal cancer in Germany

SAPHIR: real-world clinical research platform for molecular testing, treatment, and clinical and patient-reported outcomes in patients with gastroesophageal cancer in Germany

P25 Association between Adherence to Lenalidomide and Patient-Reported Outcomes in Patients with Multiple Myeloma: A Systematic Literature Search

P25 Association between Adherence to Lenalidomide and Patient-Reported Outcomes in Patients with Multiple Myeloma: A Systematic Literature Search

Abstract B105: Evaluating the racial equity of a digital health patient-reported symptom management system in patients receiving chemotherapy

Abstract INTRODUCTION. The development of behavioral &amp; supportive care interventions to improve quality of life for people receiving chemotherapy treatment for cancer, even with demonstrated overall efficacy, may unintentionally result in unequal benefit including across racial subgroups. The purpose of this study was to determine if Symptom Care at Home (SCH), is efficacious, digital health patient-reported outcome (PROs) symptom managment system, provide equitable benefit across racial subgroups. METHODS. A randomized trial was conducted to determine the active components of SCH. Participants reported daily on 11 common treatment symptoms through an Interactive Voice Response (IVR) telephone-based system that transmitted data through telephone lines. Continuous measures &amp; standard deviations with ordinal &amp; categorical measures, frequencies &amp; percentages of the totals were summarized. Comparisons between participants across Georgia &amp; Utah &amp; between Black &amp; White race were completed using Students t-test &amp; chi-square tests. Statistical analyses were completed using a 5% level of significance. This analysis compared these two groups to determine if participation with the SCH digital health tool &amp; symptom reduction benefits were equitable. RESULTS. Participants were 239 Black plus 13 Other or mixrd-race patients (251; 86%) as compared with the 118 White patients (32%) receiving chemotherapy treatment in Atlanta, Georgia. Blacks had slightly lower call compliance 67.59% (25.92%) versus (vs) Utah Whites 72.75% (22.45%) p=0.005; lower days in study Blacks 48.9% (29.9%) vs 80.8% (50.3%), p&amp;lt;0.001; &amp; lower completion of study all 3 cycles of chemotherapy &amp; still calling (65.4% vs 75.2%), p&amp;lt;0.001. Georgians also had significantly lower average total alerts 5.08% (10.69%) vs Utah 8.12% (15.20%), p&amp;lt;0.001 and lower presence of at least one moderate/severe symptom for most of the 11 symptoms. Georgians were more likely to be Female (72.2% vs 49.2%, p&amp;lt;0.001); Non-marreid (37.7% vs 72.9%, p&amp;lt;0.001); Non-degree holder (59.9% vs 39.8%, p&amp;lt;0.001); &amp; have diagnosis of Breast Cancer (34.9% vs 12.7%). Blacks had slightly lower call complaince 65.17% (27.1%) vs Whites 72.75% (22.45%), p=0.005; but with no statistically significant difference in number of days in study 49.0% (30.2%) vs 48.6% (29.5%), p=0.911; no statistically significant difference in completion of all 3 cycles of chemotherapy (65.4% vs 63.5%, p=0.895); with difference in average number of total alerts 4.89% (10.93%) vs 5.48% (10.20%, p=0.621). CONCLUSIONS. This study found no racial diffrences in how participants engaged the SCH digital health platform or lenght of study, although the Black plus other raccial group reported daily symptoms 7.5% less days than the White grpup. The degree of benefit found from the SCH was equitably distributed across racial categories. Carefully designed digital health tools utilized to measure &amp; manage PROs in patients receiving chemotherapy can achieve equitable symptom benefit across racial groups &amp; may contribute to reducing racial diparities in cancer symptom care. Citation Format: Mary Gullatte, Eli Iacob, Gary Donaldson, Kathi Mooney. Evaluating the racial equity of a digital health patient-reported symptom management system in patients receiving chemotherapy [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr B105.

Improved Patient-reported Outcomes in Patients Aged 16 and Younger at Two Years After Anterior Cruciate Ligament Reconstruction Despite Relatively High Rates of Reinjury and Repeat Surgery.

Anterior cruciate ligament reconstruction (ACLR) in adolescent patients, particularly those aged 16 and under, are increasingly common procedure that lacks robust clinical and patient-reported outcome (PRO) data. The purpose of this study was to report 2-year PROs of patients receiving ACLR aged 16 or younger using the single assessment numerical evaluation (SANE) and knee injury and osteoarthritis outcome score (KOOS). Secondary aims included characterizing treatment characteristics, return to sport (RTS), and clinical outcomes. The institutional PRO database was queried for patients receiving ACLR from 2009 to 2020. Patients aged older than 16, revision procedures, concomitant ligament repairs/reconstructions, and patients without full outcome data at 2 years were excluded. Outcomes over 2 years after ACLR included SANE, KOOS, reinjuries, reoperations, and time to RTS. A total of 98 patients were included with an average age of 15.0 years. Most patients were females (77.6%). Bone-tendon-bone autograft (69.4%) was the most used. Average RTS was 8.7 months (range: 4.8 to 24.0mo), with 90% of patients eventually returning to sport. A total of 23 patients (23.5%) experienced a reinjury and 24.5% (n = 24) underwent reoperation. Timing to RTS was not associated with reinjury, but patients who returned between 9.5 and 13.7 months did not sustain reinjuries. Mean KOOS and SANE scores at 2 years were 87.1 and 89.1, respectively, with an average improvement of +18.4 and +22.9, respectively. Change in KOOS was negatively impacted by reinjury to the anterior cruciate ligament graft and reoperation (anterior cruciate ligament failure: +10.0 vs 19.3, P = 0.081, respectively; reoperation: +13.2 vs +20.1, P = 0.051, respectively), though these did not reach statistical significance. Patients experienced improved SANE and KOOS scores after ACLR. Rates of reinjury and reoperation were relatively high and negatively impacted PRO scores but were not associated with the timing of RTS. Adolescent patients should be counseled regarding the risk of subsequent ipsilateral and contralateral knee injury after ACLR. Level IV-case series.

HJKC3-007: Outcomes of Patients with Chronic Myeloid Leukemia in Chronic Phase Treated with Asciminib and Other Tyrosine Kinase Inhibitors in Routine Clinical Practice

Background and significance: There are typically high response rates to first line TKI therapies in chronic phase chronic myeloid leukemia (CP-CML). However, responses in later lines (second line and beyond) are diminished and highly dependent on the specific tyrosine kinase inhibitors (TKIs) used. Asciminib received FDA approval in October 2021 for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) CML-CP who were previously treated with two or more TKIs, and in patients with Ph+ CML-CP with the T315I mutation. Our goal in this study is to evaluate the role of asciminib therapy for patients with CML beyond clinical studies, in routine clinical practice. Study Design and methods: Data for this study will be abstracted from the HJKC3 (H. Jean Khoury Cure CML Consortium) CML registry project (HJKC3-0005); the HJKC3 CML Registry is a collaborative academic multi-site registry. Patients will be consented to allow collection of both retrospective and prospective data for the HJKC3 CML Registry. The data forms and surveys will be built and managed through the Research Electronic Data Capture (REDCap), a secure web application managed by the Clinical &amp; Translational Science Institute. Participating sites include members of the HJKC3 (curecml.org). This study will be an opportunity to evaluate asciminib usage in ‘real-world’ academic practices across the United States. This observational study will include cohorts of patients diagnosed with CP-CML previously treated with two or more tyrosine kinase inhibitors and/or receiving asciminib and/or those with a T315I mutation, not currently enrolled in a randomized controlled trial. The HJKC3 CML Registry intends to collect clinical and patient reported outcome (PRO) data. After obtaining patient consent, patients will be invited to complete PRO assessments. The study will attempt to collect PRO data regardless of disease or treatment status. PRO assessments will be primarily administered online, though study staff will offer alternatives (e.g., phone) for participants without internet access. Study subjects will be emailed a link to access a secure platform hosted by one of the study sites, Medical College of Wisconsin (MCW), using the REDCap platform. Study Objectives: The primary objective of the study is to describe characteristics of patients who were previously treated with two or more TKIs and treated with asciminib or with any other TKIs. The secondary objectives are to describe the clinical outcomes and PRO of those patients. Exploratory objectives include description of characteristics, treatment outcome and PRO for patients with T315I mutation. Statistical plan: The sample size of approximately 225 participants during the 5-year recruitment period is based on the available clinical expertise and ongoing recruitment data in the HJKC3 CML registry in lieu of statistical power analysis. We estimate that 150 patients in the HJKC3 CML registry will be treated with other TKI and 75 treated with asciminib. Among a total of 225 patients, we estimate that 75 patients with the T315I mutation will be enrolled in the registry. No formal statistical inference will be drawn to compare the outcomes between these two groups. Bayesian predictive probability (PP) will be utilized for the exploratory analysis of Major Molecular Response (MMR). Survival probabilities will be computed using the Kaplan-Meier method, and the p-values from the log-rank test will be provided. Different PRO domains of the patient's symptoms and functioning will be analyzed separately (e.g., depression separate from fatigue, separate from GI symptoms, etc.) since combining them into a summary score may dilute the effects of the individual (and not necessarily related) components and mask actual change. The main objective for the analyses of PRO data from the registry is to describe any differences by treatment type in patients treated with asciminib and other TKIs.

Clinical outcomes of immunoglobulin treatment for patients with secondary antibody deficiency: Data from the Ontario immunoglobulin treatment case registry.

Despite the increasing number of cases of secondary antibody deficiency (SAD) and immunoglobulin (Ig) utilization, there is a paucity of data in the literature on clinical and patient-reported outcomes in this population. To describe immunoglobulin utilization patterns, clinical and patient-reported outcomes in patients with SAD on immunoglobulin replacement therapy (IgRT). A cross-sectional study of patients with secondary antibody deficiency enrolled in the Ontario Immunoglobulin Treatment (ONIT) Case Registry from June 2020 to September 2022 was completed. Demographics, comorbidities, indications for immunoglobulin treatment, clinical infections at baseline and post IgRT, and patient-reported outcomes were collected and analyzed. There were 140 patients (58 males; 82 females; median age 68) with SAD during the study period; 131 were on subcutaneous Ig (SCIG) and 9 were on intravenous Ig (IVIG). The most common indication was chronic lymphocytic leukemia (CLL) (N = 52). IgRT reduced the average annual number of infections by 82.6%, emergency room (ER) visits by 84.6%, and hospitalizations by 83.3%. Overall, 84.6% of patients reported their health as better compared to before IgRT. Among those patients who switched from IVIG to SCIG (N = 35), 33.3% reported their health as the same, and 62.9% reported their health as better. This study demonstrates that IgRT significantly improved clinical outcomes and patient-reported general health state in patients with SAD. This study also further supports the use of SCIG in patients with SAD.

Greater improvement in Neck Disability Index scores in women after surgery for cervical myelopathy: an analysis of the Quality Outcomes Database

OBJECTIVE There is a high prevalence of cervical myelopathy that requires surgery; as such, it is important to identify how different groups benefit from surgery. The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry, that includes demographic, clinical, and patient-reported outcome data to measure the safety and quality of neurosurgical procedures. In this study, the authors assessed the impact of gender on patient-reported outcomes in patients who underwent surgery for cervical myelopathy. METHODS The authors analyzed 1152 patients who underwent surgery for cervical myelopathy and were included in the QOD cervical module. Univariate comparison of baseline patient characteristics between males and females who underwent surgery for cervical spondylotic myelopathy was performed. Baseline characteristics that significantly differed between males and females were included in a multivariate generalized linear model comparing baseline and 1-year postoperative Neck Disability Index (NDI) scores. RESULTS This study included 546 females and 604 males. Females demonstrated significantly greater improvement in NDI score 1 year after surgery (p = 0.036). In addition to gender, the presence of axial neck pain and insurance status were also significantly predictive of improvement in NDI score after surgery (p = 0.0013 and p = 0.0058, respectively). CONCLUSIONS Females were more likely to benefit from surgery for cervical myelopathy compared with males. It is important to identify gender differences in postoperative outcomes after surgery in order to deliver more personalized and patient-centric care.

17 Comparing Cognitive Patient-Reported Outcomes with Neuropsychological Impairment in Patients with Diffuse Glioma.

Objective:Cognitive difficulties among diffuse glioma survivors are common in survivorship due to cancer treatment effects (i.e., surgery, chemotherapy, and/or radiation therapy), which can diminish quality of life. Routine monitoring of cognitive symptoms in survivorship is recommended and can help address patient needs and inform clinical interventions (e.g., cognitive rehabilitation). While several patient-reported outcome (PRO) measures have been used in brain tumor populations, there has been few studies comparing the performance of these PROs in patients with diffuse glioma. In order to better understand the value of different PROs, we conducted preliminary analyses associating cognitive PROs with neuropsychological impairment in a well-characterized sample of patients with diffuse glioma.Participants and Methods:23 glioma patients (mean aged 44.26 ± 12.24), six or more months after completing cancer treatment, underwent comprehensive psychosocial and neuropsychological assessments. The neuropsychological battery included the Hopkins Verbal Learning Test - Revised, Brief Visuospatial Memory Test - Revised, Wechsler Adult Intelligence Scale-IV tests of Coding and Digit Span, Trail-Making Test, Stroop Test, FAS, Animals, Boston Naming Test, and Rey-Osterrieth Complex Figure (copy). Completed cognitive PROs included the Functional Assessment of Cancer - Cognitive Function and Brain questionnaires (FACT-Cog; FACT-Br), the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Brain Neoplasms (EORTC QLQ-BN20), and the Multidimensional Fatigue Symptom Inventory, short form (MFSI-SF) Mental subscale. Based on published norms, we divided the sample into cognitively impaired and non-impaired groups (two or more primary neuropsychological test scores &lt;= -2 z-score). We compared PRO scores between impaired and non-impaired groups using Mann-Whitney U tests. Higher medians equate to better cognitive functioning for all PROs, except for the MSFI-SF.Results:We found significantly worse scores in the impaired group compared to non-impaired group on the FACT-Cog subscales of perceived cognitive ability (PCA), [Non-Impaired (Mdn = 21, n = 11), Impaired (Mdn = 10, n = 12), U = 22.5, z = -2.68, = 0.007], perceived cognitive impairment (PCI), [Non-Impaired (Mdn = 59, n = 11), Impaired (Mdn = 44, n = 12), U = 32.5, z = -2.06, p=0.039]. The impaired group also trended towards worse scores on the FACT-Br additional concerns subscale [Non-Impaired (Mdn = 79.5, n = 10), Impaired (Mdn = 61, n = 12), U = 32.5, z = -1.81, p=0.07]. Group differences were not observed on the MSFI-SF [Non-Impaired (Mdn = 5, n = 11), Impaired (Mdn = 7, n = 12), U = 40.5, z = -1.57, p=0.12], or EORTC Cognitive Functioning subscale [Non-Impaired (Mdn = 83.33, n = 10), Impaired (Mdn = 75, n = 12), U = 42, z = -1.23, p=0.218].Conclusions:The preliminary findings suggest that the FACT-Cog, especially the PCA and PCI correspond with neuropsychological impairment among diffuse glioma survivors better than other cognitive PROs. The FACT-Br subscale was somewhat effective. The MFSI-SF Mental and EORTC Cognitive Functioning subscales did not correspond to impairment status. The FACT-Cog is a promising instrument and future work is needed to better determine relative utility of cognitive PROs in this population.

Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study

IntroductionThe use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs...

Physician- and Patient-Reported Outcomes of the MC1635 Phase 3 Trial of Ultrahypofractionated Versus Moderately Hypofractionated Adjuvant Radiation Therapy After Breast-Conserving Surgery

Our aim was to report physician- and patient-reported outcomes of patients with localized breast cancer treated with moderate versus ultrahypofractionated whole breast irradiation (WBI) after breast-conserving surgery (BCS). Between February 2018 and February 2020, patients with localized breast cancer (pT0-3 pN0-1 M0) were offered participation in a phase 3 randomized clinical trial assessing adjuvant moderate hypofractionation (MHF) to 40 Gy in 15 fractions versus ultrahypofractionation (UHF) to 25 Gy in 5 fractions after BCS, with an optional simultaneously integrated boost. Toxicities, cosmesis, and quality of life were assessed at baseline, end of treatment (EOT), and 3 months, 1 year, 2 years, and 3 years from irradiation using validated metric tools. One hundred seven patients were randomized to MHF (n = 54) or UHF (n = 53) adjuvant WBI. The median follow-up was 42.8 months. Grade 2 radiation dermatitis was experienced by 4 patients (7.4%) in the MHF arm and 2 patients (3.7%) in the UHF arm at EOT (P = .726). No grade 3 or higher toxicities were observed. Deterioration of cosmesis by physician assessment was observed in 2 (6.7%) patients treated in the UHF arm and 1 (1.9%) patient treated in the MHF arm at EOT (P = .534), whereas at 3 months, only 1 (1.8%) patient treated in the MHF arm demonstrated deterioration of cosmesis (P = .315). At EOT, 91% and 94% of patients reported excellent/good cosmesis among those treated with MHF and UHF regimens, respectively (P = .550). At 3 months, more patients within the MHF arm reported excellent/good cosmesis compared with those in the UHF arm (100% vs 91%; P = .030). However, the difference in patient-reported cosmesis disappeared at the 1-, 2-, and 3-year time points. UHF WBI showed similar treatment-related late toxicities and similar provider-scored cosmesis compared with MHF radiation in patients treated adjuvantly after BCS.

Satisfactory patient-reported outcomes in patients treated with impaction bone grafting and autologous matrix-induced chondrogenesis for osteochondral knee defects.

Osteochondral knee defects usually affect young, active patients and may alter knee biomechanics and progressively lead to joint degeneration. Various treatment options exist with autologous, impaction bone grafting in combination with autologous matrix-induced chondrogenesis (BG-AMIC) being a less-expensive, one-step, promising option. The purpose of this study is to evaluate the clinical and radiological mid-term outcomes of large osteochondral lesions treated with BG-AMIC, identify a possible correlation between the two and report postoperative complications and reoperation rate. A retrospective analysis of 25 patients treated with the BG-AMIC technique for knee osteochondral lesions was performed. Patients were assessed using the following PROMs: the IKDC, the KOOS and the Lysholm score, the Tegner activity scale and a patient acceptable symptom state (PASS). TheEQ-5D-5L score was used to assess health-related quality of life. Radiological assessment was performed using the MOCART 2.0 score on a 3T MRI. At a mean of 3.8 (± 0.8)-year follow-up, all functional scores increased significantly (p < 0.005) when compared to the preoperative baseline. IKDC increased from 44.5 (± 15.9) to 81.4 (± 14.7), KOOS from 41.5 (± 16.1) to 91.6 (± 11.6) and Lysholm from 54.4 (± 23) to 95.2 (± 5.5) (p < 0.005). The EQ-5D-5L score also revealed a significant improvement [59.9 (± 25) to 93.4 (± 10.2), p < 0.005]. Mean Tegner score reached pre-injury levels. The PASS was positive in 100% of patients. The minimum clinically important difference was reached in all PROMs except for the KOOS Sports subscale. There were no re-operations. Morphological evaluation of the repair tissue using the MOCART 2.0 score revealed a mean total score of 52.8 (± 30.5). A statistically significant, positive correlation was found between the MOCART 2.0 score and the IKDC score, the KOOS ADL subscale and the EQ-5D-5L (p < 0.05). BG-AMIC is a safe and reliable option for treating deep, knee osteochondral lesions, providing a statistically significant and clinically important improvement in patient-reported outcomes. No complications were noticed, and no re-operations were performed after the procedure. A moderate positive correlation between the MOCART 2.0 score and the IKDC, KOOS ADL and EQ-5D-5L was noticed. However, this correlation is not necessarily clinically relevant, and excellent clinical results can be expected even in patients with low MOCART scores. III.

Resilience and Patient-Reported Outcomes in Patients Undergoing Orthopedic Hand Surgery.

Previous studies have examined the impact of resiliency on postoperative outcomes in other orthopedic domains, but none to date have done so for hand surgery. We performed a retrospective analysis of prospectively collected data of patients undergoing hand surgery at a single institution. We included patients with complete preoperative outcomes scores and 6-month follow-up. All patients completed the Brief Resilience Scale (BRS), Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), Veterans RAND 12-Item Health Survey (VR-12), and Numeric Rating Scale (NRS) for pain. Patients were stratified into high-resiliency (HR) and low-resiliency (LR) groups based on the preoperative BRS score, and outcomes between groups were compared. We identified 91 patients who underwent hand procedures and completed full preoperative and postoperative outcomes measures. There were no observed preoperative differences between the groups in all outcomes scores except the VR-12 Mental Component Score. Postoperatively, the HR group had superior DASH, QuickDASH, and VR-12 (mental and physical component) scores than the LR group. Postoperative pain, as measured by the NRS, was significantly lower in the HR group despite there being no preoperative difference. A larger percentage of patients in the HR group met the minimal clinically important difference in all outcomes except for the VR-12 Mental Component Scores. Patients with high preoperative resilience appear to have significantly better clinical outcomes following hand surgery with superior DASH, QuickDASH, and VR-12 scores at 6-month follow-up. Prognostic study/Level IV evidence.

Long-term behavior and functional outcomes of ileal-pouch anal anastomosis in inflammatory bowel disease with changing phenotype

BackgroundIleal-pouch-anal anastomosis is the operation of choice after proctocolectomy for ulcerative colitis; some patients will develop Crohn’s disease. We aim to determine long-term behavior and outcomes of inflammatory bowel disease–ileal-pouch-anal anastomosis after colectomy, where a specialist gastrointestinal pathologist re-evaluated the initial colectomy specimen. MethodsPatients with inflammatory bowel disease–ileal-pouch-anal anastomosis were identified from a single-surgeon prospective database containing 1,165 patients accrued from 1991 to 2017 and invited to complete pouch-function and quality-of-life assessments. Medical records were used to obtain clinical outcomes and subjective functional assessments for those unable to be contacted. Data were compared between patients with and without histological assessment disagreement and subsequent inflammatory bowel disease behavior subgroups. ResultsFor 138 patients included in the analysis, the median follow-up was 22.5 (range: 5–39) years. A total of 39.1% of patients had histologic diagnostic change after gastrointestinal pathologist review, and 19% and 39% developed Crohn’s disease-like disease behavior at 10- and 20-year follow-ups. Pouch function and quality-of-life scores were similar across diagnostic change subgroups. Pouch failure was higher in Crohn’s-like disease (31.1 vs 13.0%, P < .05). Intestinal continuity was maintained in 68.9% of Crohn’s disease-like patients, 57.9% required biologics. Gastrointestinal pathologist review did not alter the time to new diagnosis (P = .419) or time to pouch failure (P = .320), mean: 11.0 and 11.41 years, respectively. ConclusionWe describe equivocal patient-reported outcomes in patients with ileal-pouch-anal anastomosis and changing histologic and clinical diagnosis. Although pouch excision and biologic use rates are higher, many Crohn’s disease-like patients maintain their pouch. Diagnostic change and pouch failure often occur >10 years after ileal-pouch-anal anastomosis creation. This supports the consideration of ileal-pouch-anal anastomosis after colectomy in carefully selected patients with inflammatory bowel disease, even those with ambiguous histology and the need for close long-term follow-up.

Outcome of joint replacement in patients with underlying rheumatoid disease

Artificial joint replacement is ameaningful treatment option for patients with advanced rheumatic degenerative joint diseases. The aim of this study was to investigate the influence of the underlying rheumatic diseases on postoperative complications and patient-reported outcome (PRO) after elective total joint replacement (TJR). In aretrospective analysis of 9149 patients with elective total knee or total hip arthroplasty (TKR and THR), complication rates and PRO of patients with and without rheumatic diseases (RD) were compared. Multivariate logistic regression models were used to determine whether the underlying rheumatic disease was an independent risk factor for various complications. In the univariate analyses the RD patients had an increased risk of medical complications (7.1% vs. 5.2%; p = 0.028) and Clavien-Dindo gradeIV complications (2.8% vs. 1.8%; p = 0.048) after TJR. This was confirmed in multivariate statistical analyses (p < 0.034). The rates for operative revisions and surgical complications were comparable (2.5% vs. 2.4%; p = 0.485). Analysis of the PRO showed ahigher responder rate in patients with RD after TKR (91.9% vs. 84.5%, p = 0.039). In contrast, the responder rate in patients with RD after THR was comparable (93.4% vs. 93.2%, p = 0.584). Despite increased postoperative complication rates, patients with underlying rheumatic diseases showed acomparable outcome 1 year after TJR. After TKR the RD patients showed even higher responder rates. Although RD patients are avulnerable patient group, they can still benefit from joint replacement.

Complication Rates and Functional Outcomes after Total Ankle Arthroplasty in Patients with Rheumatoid Arthritis

Category: Ankle Arthritis; Other Introduction/Purpose: Utilization rates of total ankle arthroplasty (TAA) have greatly increased in recent years. For patients with rheumatoid arthritis (RA) undergoing TAA, conflicting data have been reported regarding risk of complications and patient reported outcome (PRO) improvement when compared to patients with osteoarthritis. The purpose of this study is to compare complication rates and PROs of patients with RA to patients with osteoarthritis and posttraumatic arthritis. Methods: This was a retrospective study of 1,071 primary TAA performed at a single institution between 2001 and 2020. Minimum follow-up was two years. Patients were stratified by indication for TAA (osteoarthritis, n=372; posttraumatic arthritis, n=642; RA, n=57). Patient demographics, intraoperative variables, postoperative complications, and PRO measures were compared between groups using univariable statistics. Multivariable Cox regression was performed to assess risk for implant failure. Mean follow-up was 5.6 years (SD: 3.1). Results: Compared to the osteoarthritis and posttraumatic arthritis groups, the RA cohort had the lowest mean age (p &lt; 0.001), lowest percentage of males (p &lt; 0.001), and highest ASA score (p &lt; 0.001). Univariate analysis showed no statistically significant difference for infection rates among groups (p=1.0). The RA cohort had the highest rate of heterotopic ossification postoperatively (2/57, 3.5%, p&lt; 0.001). Multivariable regression analysis showed no increased risk of implant failure for the RA cohort (p=0.23). For the SMFA, SF-36, AOFAS-hindfoot, FAOS-symptoms, and FAOS-ADL the RA group reported the worst scores at final follow-up (p &lt; 0.001). However, the RA cohort demonstrated the largest improvements from preoperative to postoperative scores on the FADI, SF-36, and the symptoms and ADL subscales of the FAOS (p=0.04, 0.01, 0.03, 0.03). Conclusion: In the largest single institution study to date, patients with RA had the worst PRO scores compared to the osteoarthritis and posttraumatic arthritis groups. However, they experienced significantly higher improvements in functional outcomes from their preoperative baseline. Large patient samples with mid- to long-term follow up such as a presented in this series are imperative to fully understand the risk-benefit of TAA in various patient cohorts.

Evaluation of Patient-Reported Outcomes in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets in the CLAWIR Study: 12-Month Interim Analysis.

Patient-reported outcomes (PROs) provide an insightful method of assessing the subjective impact of therapies for those affected by multiple sclerosis (MS), a chronic neurologic disease notable for symptoms of fatigue and reduced physical function. The ongoing CLAWIR study aims to assess the effect of cladribine tablets (3.5mg/kg cumulative dose over 2years) in patients with highly active relapsing MS focusing on PROs of fatigue, physical function, treatment satisfaction, and work productivity. Here, we report on a pre-planned analysis at 12 months after treatment initiation with cladribine tablets. CLAWIR is a 2-year, multicenter, prospective, observational study of patients with relapsing MS newly initiating cladribine tablets. The following PROs were analyzed: PRO Measurement Information System (PROMIS®) Fatigue MS (v1.0) and Physical Function MS (v2.1), Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4), and Work Productivity and Activity Impairment MS Questionnaire (WPAI-MS). Data were analyzed descriptively. In total, 128 patients were eligible for analysis: 95 females (74.2%); median (range) age 34.5(29, 44) years; 34 patients (26.6%) were treatment-naïve, and 89 (69.5%) were early switchers from platform therapies (the remaining 5 patients [3.9%] switched from a high-efficacy disease-modifying therapy). PROMIS® Fatigue MS mean (± standard deviation [SD]) T-scores decreased from 54.6 (± 9.59) at baseline to 51.8 (± 10.30) at 12 months, indicating an alleviation of fatigue, whereas PROMIS® Physical Function MS mean T-scores remained stable over time [baseline: 49.4 (± 10.69); 12months: 50.3 (± 10.88)]. TSQM v1.4 mean scores indicated an improvement over time, increasing from 52.2 (± 27.79) at baseline to 81.4 (± 17.06) at 12months for global satisfaction. WPAI-MS scores also showed an improvement across all four domains over 12 months. This real-world study demonstrates the effect of cladribine tablets over 12 months on PROs of fatigue, physical function, treatment satisfaction, and work productivity. The CLAWIR study is registered at the German Federal Institute for Drugs and Medical Devices with the internal NIS number 7469.

Patient-reported outcomes in patients with primary immunodeficiency diseases in Japan: baseline results from a prospective observational study.

Primary immunodeficiency diseases (PIDs) are rare inherited diseases resulting in impaired immunity. People with PID experience lower health-related quality of life (HR-QOL) and disease-related burdens in daily activities. This ongoing, prospective observational study aims to evaluate disease activity, treatment status, treatment-related burden, daily activities, and HR-QOL in patients with PID in Japan over a 1-year period. In this interim report (database lock: July 29, 2022), we present baseline results. Participants were enrolled between November 2021 and May 2022; data were collected four times/year per participant until May 2023 using an online electronic patient-reported outcomes system. Patients with PID and healthy volunteers aged ≥12 years, residing in Japan, and with access to a smartphone were eligible. HR-QOL (primary endpoint) was assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). Work productivity was assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire. Other aspects of PID and burden were assessed with a new questionnaire developed in-house. The study is registered at the University hospital Medical Information Network clinical trials registry (UMIN000045622). The full interim analysis set comprised 71 patients with PID and 47 healthy volunteers. The most common International Union of Immunological Societies PID category was primary antibody deficiency (56.3% of patients). Complications were common, especially recurrent respiratory tract infections (63.4%). Most patients with PID were treated with immunoglobulin replacement therapy (73.2%); 22.4% of these patients had serum immunoglobulin levels <700 mg/dL. Among patients who did not undergo hematopoietic cell transplantation, EQ-5D-5L (n=67) and SF-36 (n=59) Physical and Mental Component Summary scores were significantly lower than in healthy volunteers (p < 0.001). WPAI absenteeism, work productivity loss, and activity impairment scores were significantly lower in 42 working patients with PID than in 37 working healthy volunteers (p < 0.05). Other results indicated that patients with PID experience substantial burdens related to medical visits, expenses, work, and daily activities. This interim analysis confirms that patients with PID in Japan have lower HR-QOL and work productivity compared with healthy individuals and experience substantial limitations and burdens in their daily lives.