Baseline Patient-reported Outcomes Research Articles

Education and Comorbidities Underlie Low Preoperative Scores: Commentary on an article by Lorraine A.T. Boakye, MD, et al.: "The Effects of Sociodemographic Factors on Baseline Patient-Reported Outcome Measures in Patients with Foot and Ankle Conditions".

Education and Comorbidities Underlie Low Preoperative Scores: Commentary on an article by Lorraine A.T. Boakye, MD, et al.: "The Effects of Sociodemographic Factors on Baseline Patient-Reported Outcome Measures in Patients with Foot and Ankle Conditions".

Paper 27: Preoperative Risk Factors of Subsequent Ipsilateral ACL Revision Surgery following an ACL Restoration Procedure

Objectives: To identify the preoperative risk factors for revision ACL surgery within the first two years after BEAR ACL repair procedure. Methods: Data from the prospective BEAR I, II, and III trials were used to determine preoperative risk factors for ACL revision surgery. All subjects with a complete ACL tear (ages between 13-47 years, depending on the trial), who passed all other inclusion/exclusion trial criteria, and underwent a primary BEAR procedure within 30-50 days from injury (dependent on trial) were included. Demographic data (age, sex, BMI), baseline patient-reported outcomes (IKDC Subjective Score, Marx Activity score), pre-operative imaging characteristics (ACL stump length, notch size, tibial slopes), and intraoperative findings (knee hyperextension, meniscal tear status) were evaluated to determine their contribution to ipsilateral revision ACL surgery risk. Results: 123 subjects, median age 17.6 years (IQR 16-23), including 67 (54%) females, met study criteria. 18 (15%) patients required revision ACL surgery in the first two years following the BEAR procedure. In bivariate analyses, younger age (p=.011), having a contact injury at the time of the initial tear (p=.048), and increased medial tibial slope (p=.029) were associated with a higher risk of ipsilateral revision surgery. Multivariable logistic regression analyses identified two independent predictors of revision: patient age and medial tibial slope. The odds of an ipsilateral revision surgery were decreased by 32% for each one-year increase in age (OR=0.684, 95% CI = 0.517 to 0.905, p=.008), and increased by 28% per each degree of increase in medial tibial slope (OR=1.280, 95% CI =1.024 to 1.601, p=.030). Sex, baseline IKDC or Marx score, knee hyperextension, or meniscus status were not significant predictors of revision. Conclusions: Younger age and higher medial tibial slope were predictors of increased odds of ipsilateral ACL revision surgery after the BEAR procedure. Younger patients with higher tibial slopes should be aware of the increased risk for revision surgery when deciding to undergo ACL restoration surgery.

Poster 220: Outcomes of Hip Arthroscopy in Patients with Hip-Spine Syndrome: A Matched-Pair Controlled Study with Minimum Two-Year Follow-Up

Objectives: Hip–spine syndrome is a phenomenon commonly seen in the geriatric population presenting with concurrent hip osteoarthritis and lumbar spine degenerative disease. Secondary hip-spine syndrome can develop when compensatory stresses are placed on the lumbosacral spine due to pathologies that limit hip range of motion, such as femoroacetabular impingement (FAI). The literature remains conflicted on the impact of hip arthroscopy in hip-spine syndrome and there is a paucity of studies that report long term outcomes. The purpose of this study was to conduct a matched-pair analysis to assess the effects of lumbar spine pathology on minimum two-year clinical outcomes of patients undergoing hip arthroscopy for FAI. Methods: An institutional review board-approved retrospective review of a prospectively collected, single-surgeon database was performed to identify patients who underwent hip arthroscopy for FAI with evidence of concomitant lumbar spine pathology. Importantly, all patients participated in the same postoperative protocol and underwent capsular management via the previously published puncture capsulotomy technique. Additionally, included patients had failed conservative treatment, a minimum of two-year follow-up, and symptoms of low back pain with objective evidence of lumbar pathology (i.e., herniation, degenerative disc disease, stenosis, spondylosis, etc.) at the time of surgery. Patients were excluded if they had any previous hip surgery, evidence of hip dysplasia (lateral center edge angle ≤25°), or advanced osteoarthritis (Tönnis ≥2). Patients in the hip-spine (HS) cohort were matched 1:1 by age within 5 years, body mass index (BMI) within 5.0 kg/m2, and sex to a matched control (MC) cohort. The MC cohort lacked subjective or objective evidence of lumbar spine pathology. The following patient- reported outcomes (PROs) were recorded in each cohort: Modified Hip Harris Score (mHHS), International Hip Outcome Tool-33 (iHOT-33), Non-Arthritic Hip Score (NAHS), rates of revision arthroscopy, and conversion to total hip arthroplasty (THA). Results: A total of 60 patients with lumbar disease (HS; age = 39.5 ±10.2, BMI = 26.3 ±4.0, 48.3% Female) were matched with 60 control patients (MC; age = 39.4 ±11.6, BMI = 25.7 ±4.1, 48.3% Female). At baseline, all PROs were significantly lower in the HS cohort (all p<0.05). At one-year follow-up, the HS cohort exhibited a greater magnitude of improvement in all PROs, with significant differences in the NAHS (p = 0.006). Additionally, a higher percentage of patients in the HS cohort achieved the minimal clinically important difference (MCID) threshold for all outcome measures at one-year, and a significant difference was identified in the NAHS (p = 0.026; Tables 1&2). At two-year follow-up, all PROs were significantly lower in the HS cohort (all p<0.05), however at three- and five-year follow-up no differences were identified between cohorts in mean PROs, magnitude of improvement, or percentage of patients achieving MCID thresholds (all p>0.05). No significant differences in the rates of revision (0% vs. 0%) or conversion to THA (5.3% vs. 3.4%) were identified between cohorts (all p>0.99). Conclusions: While patients with a history of lumbar spine pathology achieved lower short-term outcomes after hip arthroscopy, these differences were mitigated when follow-up was expanded to 3- and 5- years (Figure 1). While the HS cohort exhibited lower baseline PROs at the time of surgical intervention, these patients had an equal or greater magnitude of improvement across all time points. This study’s findings have implications for the shared decision-making process and managing patient expectations prior to undergoing hip arthroscopy for FAI. Although it may take greater than two years, patients with hip-spine syndrome can attain clinically meaningful improvement in hip function following hip arthroscopy for FAI. [Table: see text][Table: see text]

Health-related quality of life and clinical complexity of a real-life cohort of patients with advanced HR+/HER2- breast cancer treated with CDK4/6 inhibitors and endocrine therapy.

Advanced breast cancer (ABC) is characterized by multidimensional clinical complexity that is usually not considered in randomized clinical trials. In the present real-life study, we investigated the link between clinical complexity and quality of life of patients with HR+/HER2- ABC treated with CDK4/6 inhibitors. We evaluated multimorbidity burden assessed with the Cumulative Illness Rating Scale (CIRS), polypharmacy and patient-reported outcomes (PROs). PROs were assessed at baseline (T0), after 3 months of therapy (T1), and at disease progression (T2) using EORTC QLC-C30 and QLQ-BR23 questionnaires. Baseline PROs and changes between T0 and T1 were evaluated amongst patients with different multimorbidity burden (CIRS <5 and ≥5) and polypharmacy (<2 or ≥2 drugs). From January 2018 to January 2022, we enrolled 54 patients (median age 66 years, IQR 59-74). The median CIRS score was 5 (IQR 2-7), whilst the median number of drugs taken by patients was 2 (IQR 0-4). No changes in QLQ-C30 final scoring between T0 and T1 were observed in the overall cohort (p=0.8944). At T2, QLQ-C30 global score deteriorated with respect to baseline (p=0.0089). At baseline, patients with CIRS ≥5 had worse constipation than patients without comorbidities (p<0.05) and a lower trend in the median QLQ-C30 global score. Patients on ≥2 drugs had lower QLQ-C30 final scores and worse insomnia and constipation (p<0.05). No change in QLQ-C30 final score from T0 to T1 was observed (p>0.05). Multimorbidity and polypharmacy increase the clinical complexity of patients with ABC and may affect baseline PROs. The safety profile of CDK4/6 inhibitors seems to be maintained in this population. Further studies are needed to assess clinical complexity in patients with ABC.This article is part of the Tackling clinical complexity in breast cancer Special Issue: https://www.drugsincontext.com/special_issues/tackling-clinical-complexity-in-breast-cancer/.

693-P: Diabetes Distress Is Common in Newly Diagnosed Families in the 4T Study and Families Are Receptive to Psychological Services

Psychosocial states significantly impact T1D care and management for youth and their families. As part of a clinical pragmatic study, we report the number of elevated Patient Reported Outcomes (PROs) in newly diagnosed families and track their progress to psychological care. Parents/guardians (PG, n=125/133 4T Study 1 participants) and youth ≥11 years (n=60) were eligible to complete baseline, 3-, and 6-month PROs. PG completed Diabetes Distress Scale - Parent (DDS-P) and youth completed Diabetes Distress Scale (DDS-2) and PROMIS Pediatric Global Health Scale (PGH). Elevated PROs were based on published guidelines and were referred to the clinic's psychological services. Survey completeness was verified by staff to identify false flags. Staff reapproached the participant's psychologist for re-flagged PROs &amp;gt;3 months after the last visit. Over the three study time periods, a total of 99 PROs flags were evaluated (Table). At baseline, there were 32% flagged PROs, which decreased to 27% and 23% at 3 and 6 months, respectively. Elevated DDS-P was the most common reason for referral (75%). Early psychological intervention may explain the reduction in elevated PROs over the study period. With the implementation of systematic PROs in this new onset population, we observed it was common to have diabetes distress and families were receptive to psychological services. Disclosure A.Schneider-utaka: None. F.K.Bishop: None. D.P.Zaharieva: Advisory Panel; Dexcom, Inc., Research Support; Hemsley Charitable Trust, International Society for Pediatric and Adolescent Diabetes, Insulet Corporation, Speaker's Bureau; American Diabetes Association, Ascensia Diabetes Care, Medtronic. P.Prahalad: None. M.Desai: None. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. K.K.Hood: Consultant; Cecelia Health. A.Addala: None. E.Pang: None. A.L.Cortes-navarro: None. I.Balistreri: None. A.Loyola: None. N.Arrizon-ruiz: None. S.A.Alamarie: None. V.Ritter: None. B.Shaw: None. Funding National Institutes of Health (R18DK122422)

Comparing Patient-Reported Outcomes, Complications, Readmissions, and Revisions in Posterior Lumbar Fusion With, Versus Without, an Interbody Device.

Retrospective analysis on prospectively collected data. To compare posterior lumbar fusions with versus without an interbody in: (1) Patient-reported outcomes (PROs) at 1 year and (2) postoperative complications, readmission, and reoperations. Elective lumbar fusion is commonly used to treat various lumbar pathologies. Two common approaches for open posterior lumbar fusion include posterolateral fusion (PLF) alone without an interbody and with an interbody through techniques, like transforaminal lumbar interbody fusion. Whether fusion with or without an interbody leads to better outcomes remains an area of active research. The Lumbar Module of the Quality Outcomes Database was queried for adults undergoing elective primary posterior lumbar fusion with or without an interbody. Covariates included demographic variables, comorbidities, primary spine diagnosis, operative variables, and baseline PROs, including Oswestry Disability Index, North American Spine Society satisfaction index, numeric rating scale-back/leg pain, and Euroqol 5-dimension. Outcomes included complications, reoperations, readmissions, return to work/activities, and PROs. Propensity score matching and linear regression modeling were used to estimate the average treatment effect on the treated to assess the impact of interbody use on patient outcomes. After propensity matching, there were 1044 patients with interbody and 215 patients undergoing PLF. The average treatment effect on the treated analysis showed that having an interbody or not had no significant impact on any outcome of interest, including 30-day complications and reoperations, 3-month readmissions, 12-month return to work, and 12-month PROs. There were no discernible differences in outcomes between patients undergoing PLF alone versus with an interbody in elective posterior lumbar fusion. These results add to the growing body of evidence that posterior lumbar fusions with and without an interbody seem to have similar outcomes up to 1 year postoperatively when treating degenerative lumbar spine conditions.

The prognostic value of patient reported outcomes (PROs) and clinical/demographic variables in the CASPIAN study.

8516 Background: PROs have been shown to predict outcomes in non-small cell lung cancer and, using the FACT-G PRO instrument, in extensive stage small cell lung cancer (ES-SCLC). This study explored the relationships between EORTC QLQ-C30 domains and overall survival (OS) and progression free survival (PFS) in the phase III ES-SCLC CASPIAN trial, with and without adjustments for treatment (tx) and baseline clinical and demographic variables. Methods: CASPIAN had 3 treatment arms: durvalumab plus platinum–etoposide; durvalumab plus tremelimumab plus platinum–etoposide; and platinum–etoposide alone. It included the EORTC QLQ-C30, a PRO instrument consisting of 5 functioning scales (physical, role, emotional, cognitive, social), a global health status/quality of life (QoL) scale, 3 symptom scales (fatigue, nausea/vomiting, pain), 5 single item symptom assessments (dyspnea, insomnia, appetite loss, constipation, diarrhea) and a single financial difficulties item. Higher functional and QoL scores indicate better health status/function (anticipated positive OS/PFS associations) while higher symptom and financial difficulty scores represent a greater burden (anticipated negative OS/PFS associations). Baseline PRO scores were pooled across the 3 CASPIAN arms to obtain the most PRO information and used in 3 Cox proportional hazard models for OS and PFS: (A) scores only, (B) scores with a tx category for each CASPIAN arm, and (C) scores with tx categories and other baseline covariates (sex, age [ &lt; 65, ≥65], ECOG performance status [0, &gt; = 1], smoker [Y/N], CNS metastasis [Y/N], race [Asian, non-Asian], stage [III, IV], region [Asia, Europe, North and South America]). Models B and C were stratified by the type of platinum received. Backwards selection found the set of variables most associated with OS and PFS. There was no correction for multiplicity and nominal P-values &lt; 0.05 were used to assess importance. Results: The outcomes and models associated with more favorable baseline PRO scale/item scores were: (i) better OS and PFS across all 3 Cox models [physical, role, social, QoL, fatigue, pain]; (ii) better OS [emotional (models A,C), nausea/vomiting (model C), dyspnea (model C)], and (iii) better PFS [emotional (model C), financial difficulties (models A,B,C)]. Among the 90 estimated Cox hazard ratios, 82 had the anticipated directions for OS and PFS with 54/90 of the estimates having P &lt; 0.05. In each Cox model, more favorable baseline diarrhea scores were associated with reduced OS. All 15 baseline PRO score domains for OS and 10/15 for PFS were important in the stepwise selection process. Conclusions: The results largely indicate that baseline PROs had prognostic value in the CASPIAN trial across different specifications, some including tx and baseline clinical and demographic values. A better understanding of the relationship between tx and PROs may aid tx decisions. Clinical trial information: NCT03043872 .

Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks.

The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement. PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant. There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher. As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

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.

Predicting Endoscopic Improvement in Ulcerative Colitis Using the Ulcerative Colitis Severity Index.

We developed and internally validated a prognostic scoring index for ulcerative colitis (UC) patients that includes baseline patient-reported outcomes (PROs), biomarkers, endoscopy, and histology for achieving 1-year endoscopic improvement (EI). This post hoc analysis included 644 patients treated with ustekinumab induction therapy. Data were randomly split to obtain a 70% training and 30% testing cohort. Multivariate analyses assessed baseline variables and those with P < .05 were assigned weights based on their relative prognostic value from logistic regression modeling for predicting 1-year EI (Mayo endoscopic score ≤1). A cutoff was obtained by calculating the maximum Youden index and validated in the testing cohort. Prior biologic failure, albumin <40 g/L, C-reactive protein >5 mg/L, Mayo stool frequency subscore, endoscopic erosions/ulcerations, and chronic histologic structural/architectural changes demonstrated significant associations with 1-year EI and were included in the final model. The Ulcerative Colitis Severity Index (UCSI) had acceptable discriminative ability for 1-year EI in the training (area under the curve [AUC], 0.78; 95% confidence interval, 0.70-0.86) and testing cohort (AUC, 0.76; 95% CI, 0.68-0.85). Compared with the UCSI, the Mayo Clinic score demonstrated poor accuracy (AUC, 0.49; 95% CI, 0.40-0.58) for predicting 1-year EI (P = .0006). The UCSI predicted 1-year endoscopic healing (Mayo endoscopic score = 0), clinical remission (total Mayo Clinic score ≤2 and no subscore >1), partial Mayo score remission <2, and 2-item Patient-Reported Outcome score (Mayo stool frequency and rectal bleeding subscore = 0) with significantly greater accuracy compared with the Mayo Clinic score. The UCSI is an internally validated prognostic scoring tool that accurately predicts 1-year EI at baseline among moderate-to-severe UC patients initiating therapy. Further validation with additional datasets is needed.

The MS-LINK Outcomes Study Cohort: Study design and a descriptive analysis of baseline key PROs, disease, and sociodemographic characteristics (P13-3.010)

The MS-LINK Outcomes Study Cohort: Study design and a descriptive analysis of baseline key PROs, disease, and sociodemographic characteristics (P13-3.010)

OA04 Association of clinical and demographic factors with quality of life, functional status, depression, and fatigue in patients presenting with, and at risk of, rheumatoid arthritis

Abstract Background/Aims Rheumatoid arthritis (RA) is often preceded by symptomatic phases during which classification criteria are not fulfilled. The health burden of these “at-risk” stages is not well described. This study assessed health-related quality of life (HRQoL), functioning, fatigue and depression in newly presenting patients with clinically suspect arthralgia (CSA), unclassified arthritis (UA) and RA. Methods Cross-sectional analysis of baseline Patient-Reported Outcome Measures (PROMs) was conducted in 838 patients with CSA, UA or RA recruited to the Birmingham Early Arthritis Cohort. HRQoL, function, depression and fatigue at presentation were assessed using EQ-5D, HAQ-DI, PHQ-9 and FACIT-F, respectively. Descriptive statistics and multivariate linear regression were performed to assess associations between clinical/demographic variables and PROMs. Results Patients with RA at initial presentation had worse PROMs than those with CSA or UA. However, HRQoL was decreased in all groups. In patients with CSA/UA, HRQoL was comparable to data relating to chronic conditions such as heart failure, severe COPD or mild angina from the Health Survey for England (HSE). Associations between predictor variables and PROMs are summarised in Table 1. Increased functional disability was associated with female sex, older age, obesity, lower quintiles of social deprivation, increased disease activity and polypharmacy. HRQoL was associated with increased disease activity and polypharmacy. The severity of depression (PHQ-9) increased with older age, increasing BMI, living in areas with the lowest quintile of social deprivation, increased disease activity and polypharmacy. Fatigue (FACIT-F) was associated with female sex, increasing BMI, disease activity and polypharmacy. After adjusting for the demographic and clinical factors, the diagnosis assigned at baseline did not affect any of the studied PROMs, but disease activity and polypharmacy were strongly linked to poorer scores across all PROMs. Conclusion Patients with musculoskeletal symptoms who are at risk of RA present with a high health burden. Early intervention may be needed to improve quality of life from initial presentation. Disclosure B. Torlinska: Corporate appointments; BT is employed by Visible Analytics Ltd.. Grants/research support; BT receives funding from the NIHR. K. Raza: Consultancies; KR declares personal fees from Abbvie and Sanofi outside of the submitted work. Grants/research support; KR declares funding from Bristol Myers Squibb outside of the submitted work, KR is supported by the NIHR Birmingham Biomedical Research Centre, the MRC Versus Arthritis Centre for Musculoskeletal Ageing Research and the Research into Inflammatory Arthritis Centre Versus Arthritis, University of Birmingham, UK. A. Filer: Grants/research support; AF is supported by the NIHR Birmingham Biomedical Research Centre, the MRC Versus Arthritis Centre for Musculoskeletal Ageing Research and the Research into Inflammatory Arthritis Centre Versus Arthritis, University of Birmingham, UK, AF declares funding outside of the submitted work from Abbvie, Roche, Janssen, UCB, Nascient, Mestag, GSK. G. Jutley: None. I. Sahbudin: None. R. Singh: None. P. de Pablo: None. E. Rankin: None. B. Rhodes: None. N. Amft: None. E. Justice: None. C. McGrath: None. S. Baskar: None. J. Trickey: None. M. Calvert: Consultancies; MC has received personal fees outside of the submitted work from Astellas, Aparito Ltd., CIS Oncology, Takeda, Merck, Daiichi Sanko, Glaukos, GSK, and the Patient-Centered Outcomes Research Institute. Grants/research support; MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research and is a NIHR Senior Investigator, MC receives funding from NIHR, UKRI, NIHR Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK Spine and Health Data Research at the University of Birmingham and University Hospitals Birmingham, UK, Innovate UK (part of UK Research and InnovatioRin), Macmillan Cancer Support, UCB Pharma, Janssen, GSK, and Gilead. M. Falahee: None.

Quel est l’impact des traitements hormonaux féminins sur le système cardiovasculaire ?

To systematically review and report the mid- to long-term patient reported outcomes (PROs) following hip labral reconstruction.A literature search of the Pubmed, Embase, and Cochrane Library databases was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for clinical studies reporting mid- to long-term PROs at minimum five year follow-up following arthroscopic hip labral reconstruction. A quality assessment was performed using the Methodological Index of Non-Randomized Studies (MINORS) grading system. Data collection included study characteristics, demographics, indications, radiographic metrics, perioperative findings, surgical technique, baseline and most recent PROs, and subsequent surgeries.Four studies met inclusion criteria, with 182 hips (age range, 27.9 to 38.7 years) undergoing labral reconstruction in primary and revision hip surgery with minimum five year follow-up. There were three level III studies and one level IV study, with an average MINORS score of 16.6. All studies cited labral tissue characteristics as a factor for surgical indications, including the quality and/or size of the labrum. Three studies performed segmental labral reconstructions, while another study utilized a circumferential technique. Varying grafts were selected, including hamstring autograft/allograft, ligamentum teres autograft, iliotibial band autograft, and tensor fascia lata autograft. All studies demonstrated improved PROs from baseline to most recent follow-up, with four studies reporting modified Harris Hip Score (mHHS) values that increased from baseline (range, 58.9 to 66.8) to most recent follow-up (range, 80.1 to 86.3). After labral reconstruction, rates of revision arthroscopy ranged from 4.8% to 13.3% and conversion to total hip arthroplasty ranged from 1.6% to 27%.Improved PROs were observed in all studies at minimum 5-year follow-up, suggesting that labral reconstruction can offer durable results beyond short-term follow-up. While surgical indications for all studies included labral tissue characteristics, differing graft selection and surgical techniques were utilized across studies, limiting the ability to determine an optimal treatment approach.

The Effects of Sociodemographic Factors on Baseline Patient-Reported Outcome Measures in Patients with Foot and Ankle Conditions.

Racial and ethnic care disparities persist within orthopaedics in the United States. This study aimed to deepen our understanding of which sociodemographic factors most impact patient-reported outcome measure (PROM) score variation and may explain racial and ethnic disparities in PROM scores. We retrospectively reviewed baseline PROMIS (Patient-Reported Outcomes Measurement Information System) Global-Physical (PGP) and PROMIS Global-Mental (PGM) scores of 23,171 foot and ankle patients who completed the instrument from 2016 to 2021. A series of regression models was used to evaluate scores by race and ethnicity after adjusting in a stepwise fashion for household income, education level, primary language, Charlson Comorbidity Index (CCI), sex, and age. Full models were utilized to compare independent effects of predictors. For the PGP and PGM, adjusting for income, education level, and CCI reduced racial disparity by 61% and 54%, respectively, and adjusting for education level, language, and income reduced ethnic disparity by 67% and 65%, respectively. Full models revealed that an education level of high school or less and a severe CCI had the largest negative effects on scores. Education level, primary language, income, and CCI explained the majority (but not all) of the racial and ethnic disparities in our cohort. Among the explored factors, education level and CCI were predominant drivers of PROM score variation. Prognostic Level IV . See Instructions for Authors for a complete description of levels of evidence.

The Benefit in Patient-Reported Outcomes After Total Knee Arthroplasty was Comparable Across Income Quartiles

BackgroundFew studies have assessed how socioeconomic status (SES) influences patient-reported outcomes (PROMs) after total knee arthroplasty (TKA). This study evaluated the impact of patient median ZIP code income levels on PROMs after TKA. MethodsWe retrospectively reviewed patients at our institution undergoing primary, unilateral TKA from 2017 to 2020. Patients who did not have one-year postoperative PROMs were excluded. Patients were stratified based on the quartile of their home ZIP code median income from United States Census Bureau data. There were 1,267 patients included: 98 in quartile 1 (median income ≤ $46,308) (7.7%); 126 in quartile 2 (median income $46,309-$57,848) (10.0%); 194 in quartile 3 (median income $57,849-$74,011) (15.7%); and 849 in quartile 4 (median income ≥ $74,012) (66.4%). We collected baseline demographic data, 2-year outcomes, and PROMs preoperatively, as well as at 12 weeks and one year, postoperatively. ResultsThe Knee Injury and Osteoarthritis Outcome Score for Joint Replacement was significantly higher in quartile 4 preoperatively (P < .001), 12 weeks postoperatively (P < .001), and one year postoperatively (P < .001). There were no significant differences in delta improvements of Knee Injury and Osteoarthritis Outcome Score for Joint Replacement from preoperative to 12 weeks or one year postoperatively. There were no significant differences in lengths of stay, discharge dispositions, readmissions, or revisions. ConclusionPatients from lower income areas have slightly worse knee function preoperatively and worse outcomes following TKA. However, improvements in PROMs throughout the first year postoperatively are similar across income quartiles, suggesting that patients from lower income quartiles achieve comparable therapeutic benefits from TKA. Level III EvidenceRetrospective Cohort Study.

Patient-Reported Outcomes Over 24 Months in Pediatric CKD: Findings From the MyKidneyHealth Cohort Study

The lived experience of children with chronic kidney disease (CKD) is poorly characterized. We examined the associations between patient-reported outcome (PRO) scores measuring their fatigue, sleep health, psychological distress, family relationships, and global health with clinical outcomes over time in children, adolescents, and younger adults with CKD and investigated how the PRO scores of this group compare with those of other children, adolescents, and younger adults. Prospective cohort study. 212 children, adolescentss, and adults aged 8 to 21 years with CKD and their parents recruited from 16 nephrology programs across North America. CKD stage, disease etiology, and sociodemographic and clinical variables. PRO scores over 2 years. We compared PRO scores in the CKD sample with a nationally representative general pediatric population (ages 8 to 17 years). Change of PROs over time and association of sociodemographic and clinical variables with PROs were assessed using multivariable regression models. For all time points, 84% of the parents and 77% of the children, adolescents, and younger adults completed PRO surveys . The baseline PRO scores for the participants with CKD revealed a higher burden of fatigue, sleep-related impairment, psychological distress, impaired global health, and poorer family relationships compared with the general pediatric population, with median score differences≥1 SD for fatigue and global health. The baseline PRO scores did not differ by CKD stage or glomerular versus nonglomerular etiology. Over 2 years, PROs were stable with a<1-point annual change on average on each measure and intraclass correlation coefficients ranging from 0.53 to 0.79, indicating high stability. Hospitalization and parent-reported sleep problems were associated with worse fatigue, psychological health, and global health scores (all P<0.04). We were unable to assess responsiveness to change with dialysis or transplant. Children with CKD experience a high yet stable burden of impairment across numerous PRO measures, especially fatigue and global health, independent of disease severity. These findings underscore the importance of assessing PROs, including fatigue and sleep measures, in this vulnerable population. Children with chronic kidney disease (CKD) have many treatment demands and experience many systemic effects. How CKD impacts the daily life of a child is poorly understood. We surveyed 212 children, adolescents, and younger adults with CKD and their parents over 24 months to assess the participants' well-being over time. Among children, adolescents, and younger adults with CKD we found a very high and persistent burden of psychological distress that did not differ by degree of CKD or type of kidney disease. The participants with CKD endorsed greater impairment in fatigue and global health compared with healthy children, adolescents, and younger adults, and parent-reported sleep problems were associated with poorer patient-reported outcome (PRO) scores across all domains. These findings emphasize the importance of including PRO measures, including fatigue and sleep measures, into routine clinical care to optimize the lived experience of children with CKD.

Feasibility and first results of the ‘Trials-within-Cohorts’ (TwiCs) design in patients undergoing radiotherapy for lung cancer

Background: ‘Trials-within-Cohorts’ (TwiCs), previously known as ‘cohort multiple randomized controlled trials’ is a pragmatic trial design, supporting an efficient and representative recruitment of patients for (future) trials. To our knowledge, the ‘COhort for Lung cancer Outcome Reporting and trial inclusion’ (COLOR) is the first TwiCs in lung cancer patients. In this study we aimed to assess the feasibility and first year results of COLOR.Material and Methods: All patients diagnosed with lung cancer referred to the Radiotherapy department were eligible to participate in the ongoing prospective COLOR study. At inclusion, written informed consent was requested for use of patient data, participation in patient-reported outcomes (PROs), and willingness to participate in (future) trials. Feasibility was studied by assessing participation and comparing baseline PROs to EORTC reference values. First-year results of PROs at baseline and 3 months after inclusion were evaluated separately for stereotactic body radiotherapy (SBRT) and conventional radiotherapy patients.Results: Of the 338 eligible patients between July 2020 and July 2021, 169 (50%) participated. Among these, 127 (75%) gave informed consent to PROs participation and 110 (65%) were willing to participate in (future) trials. The inclusion percentage dropped from 77% to 33% when the information procedure was switched from in-person to by phone (due to COVID-19 pandemic measures). Baseline PROs for physical and cognitive functioning were comparable in COLOR patients compared to the EORTC reference values. No significant changes in PROs were observed 3 months after inclusion, except for a slight increase in pain scores in the SBRT group (n = 97).Conclusions: The TwiCs-design appears feasible in lung cancer patients with fair participation rates (although negatively impacted by the COVID-19 pandemic). With a planned expansion to other centers, the COLOR-study is expected to enable multiple (randomized) evaluations of experimental interventions with important advantages for recruitment, generalizability, and long-term outcome data collection.

The prognostic value of patient-reported outcomes in allogeneic hematopoietic stem cell transplantation: exploratory analysis of a randomized nutrition intervention trial

Whether patient-reported outcomes (PROs) can predict overall survival (OS) and non-relapse mortality (NRM) among recipients of allogeneic stem cell transplantation (allo-HSCT), is unclear. We performed an exploratory analysis of the prognostic value of patient-reported outcomes (PROs) among 117 recipients of allogeneic stem cell transplantation (allo-HSCT) who participated in a randomized nutrition intervention trial. Cox proportional hazards models were used to investigate possible associations between PROs collected pre-allo-HSCT (baseline) using scores from the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) and 1-year overall survival (OS), whereas logistic regression was used to study associations between these PROs and 1-year non-relapse mortality (NRM). Multivariable analyses indicated that only the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) and the European Bone Marrow Transplantation (EBMT) risk score were associated with 1-year OS. In the multivariable model including clinical-sociodemographic factors for 1-year NRM, our analysis showed that living alone (p=0.009), HCT-CI (p=0.016), EBMT risk score (p=0.002), and stem cell source (p=0.046) could be associated with 1-year NRM. Moreover, in the multivariable model, our analysis showed that only appetite loss from the QLQ-C30 was associated with 1-year NRM (p=0.026). In conclusion, in this specific setting, our analysis suggests that the commonly used HCT-CI and EBMT risk scores could be predictive for both 1-year OS and 1-year NRM, whereas baseline PROs in general were not.

Diffusion Basis Spectrum Imaging Identifies Clinically Relevant Disease Phenotypes of Cervical Spondylotic Myelopathy.

Prospective cohort study. Apply a machine learning clustering algorithm to baseline imaging data to identify clinically relevant cervical spondylotic myelopathy (CSM) patient phenotypes. A major shortcoming in improving care for CSM patients is the lack of robust quantitative imaging tools to guide surgical decision-making. Advanced diffusion-weighted magnetic resonance imaging (MRI) techniques, such as diffusion basis spectrum imaging (DBSI), may help address this limitation by providing detailed evaluations of white matter injury in CSM. Fifty CSM patients underwent comprehensive clinical assessments and diffusion-weighted MRI, followed by DBSI modeling. DBSI metrics included fractional anisotropy, axial and radial diffusivity, fiber fraction, extra-axonal fraction, restricted fraction, and nonrestricted fraction. Neurofunctional status was assessed by the modified Japanese Orthopedic Association, myelopathic disability index, and disabilities of the arm, shoulder, and hand. Quality-of-life was measured by the 36-Item Short Form Survey physical component summary and mental component summary. The neck disability index was used to measure self-reported neck pain. K-means clustering was applied to baseline DBSI measures to identify 3 clinically relevant CSM disease phenotypes. Baseline demographic, clinical, radiographic, and patient-reported outcome measures were compared among clusters using one-way analysis of variance (ANOVA). Twenty-three (55%) mild, 9 (21%) moderate, and 10 (24%) severe myelopathy patients were enrolled. Eight patients were excluded due to MRI data of insufficient quality. Of the remaining 42 patients, 3 groups were generated by k-means clustering. When compared with clusters 1 and 2, cluster 3 performed significantly worse on the modified Japanese Orthopedic Association and all patient-reported outcome measures (P<0.001), except the 36-Item Short Form Survey mental component summary (P>0.05). Cluster 3 also possessed the highest proportion of non-Caucasian patients (43%, P=0.04), the worst hand dynamometer measurements (P<0.05), and significantly higher intra-axonal axial diffusivity and extra-axonal fraction values (P<0.001). Using baseline imaging data, we delineated a clinically meaningful CSM disease phenotype, characterized by worse neurofunctional status, quality-of-life, and pain, and more severe imaging markers of vasogenic edema. II.

WEIGHT CHANGES AFTER HIP AND KNEE ARTHROPLASTY, AND THE EFFECT OF OBESITY ON OUTCOMES

Obesity is a common in individuals undergoing arthroplasty, and the potential for weight loss with improved mobility may be expected by some. The aim of this study was 1. determine the proportion that achieved weight loss after hip or knee arthroplasty, and 2. examine the effect of obesity on patient reported outcomes (PROMS) and satisfaction with surgery.Participants underwent primary TKA or THA between July 2015 and December 2020 and consented to participation in a research database with baseline PROMS, including weight, BMI, Oxford Knee, or Hip Score, and EQ5D. Participants repeated PROMS at 12 months after surgery with additional questions regarding satisfaction with surgery.3449 patients completed PROMS 1 year after arthroplasty with weight and BMI. There were 1810 THA and 1639 TKA procedures. The mean baseline BMI was higher in TKA (29.8, SD 5.2) compared to THA (27.7, SD 5.0), p=0.001. A higher proportion of TKA were classified as obese class 1 (29% TKA, 19% THA), obese class 2 (11% TKA and 6% THA), and obese class 3 (5% TKA and 2% THA), p=0.001. The mean weight loss after 1 year was 0.4kg and 0.9kg in obese THA subjects and TKA subjects respectively. In the obese &gt;5kg weight loss was achieved in 13% of TKA and 7% of THA (p=0.001). Obese experienced equivalent improvement in Oxford scores, compared to non-obese subjects. Satisfaction with surgery was reported by 95% of THA and 91% of TKA subjects with no significant differences between BMI group grades (p=0.491 THA and p=0.473 TKA).Preoperative obesity was observed in 44% of TKA and 27% of THA subjects. In the obese only 1 in 10 subjects lost 5kg or more over 12 months. Obese patients experienced equivalent improvements in outcome after arthroplasty and rates of satisfaction with surgery to the non-obese.