Multicenter Prospective Cohort Study Research Articles

Colombian surgical outcomes study insights on perioperative mortality rate, a main indicator of the lancet commission on global surgery – a prospective cohort study

Surgical care holds significant importance in healthcare, especially in low and middle-income countries, as at least 50% of the 4.2 million deaths within the initial 30 days following surgery take place in these countries. The Lancet Commission on Global Surgery proposed six indicators to enhance surgical care. In Colombia, studies have been made using secondary data. However, strategies to reduce perioperative mortality have not been implemented. This study aims to describe the fourth indicator, perioperative mortality rate (POMR), with primary data in Colombia. A multicentre prospective cohort study was conducted across 54 centres (hospitals) in Colombia. Each centre selected a 7-day recruitment period between 05/2022 and 01/2023. Inclusion criteria involved patients over 18 years of age undergoing surgical procedures in operating rooms. Data quality was ensured through a verification guideline and statistical analysis using mixed-effects multilevel modelling with a case mix analysis of mortality by procedure-related, patient-related, and hospital-related conditions. 3807 patients were included with a median age of 48 (IQR 32-64), 80.3% were classified as ASA I or II, and 27% of the procedures had a low-surgical complexity. Leading procedures were Orthopedics (19.2%) and Gynaecology/Obstetrics (17.7%). According to the Clavien-Dindo scale, postoperative complications were distributed in major complications (11.7%, 10.68-12.76) and any complication (31.6%, 30.09-33.07). POMR stood at 1.9% (1.48-2.37), with elective and emergency surgery mortalities at 0.7% (0.40-1.23) and 3% (2.3-3.89) respectively. The POMR was higher than the ratio reported in previous national studies, even when patients had a low-risk profile and low-complexity procedures. The present research represents significant public health progress with valuable insights for national decision-makers to improve the quality of surgical care. This work was supported by Universidad del Rosario and Fundación Cardioinfantil-Instituto de Cardiología grant number CTO-057-2021, project-ID IV-FGV017.

Intervention of traditional Chinese patent medicine based on syndrome differentiation in female patients after percutaneous coronary intervention due to acute coronary syndrome: a nationwide multicenter prospective cohort study

Objective: To evaluate the efficacy and safety of discriminative application of Chinese patent medicines in female patients after percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS). Methods: The study population was from the Chinese Patent Medicine (CPM) trial. CPM trial was a multicenter prospective cohort study, which enrolled patients from 40 centers in mainland China between February 2012 and December 2015, with the discriminative use of Chinese patent medicines as the exposure factor. Female patients with ACS after PCI who completed 36-month follow-up were included in this analysis, and were divided into a conventional treatment group (using conventional western medicine recommended by the guidelines) and a group with the discriminative use of proprietary Chinese medicines (on the basis of conventional western medicine treatment, discriminative use of Qishen Yiqi dropping pills for Qi deficiency and blood stasis syndrome, Guanxin Danshen dropping pills for blood stasis syndrome, and Danlou tablets for phlegm and blood stasis syndrome combined with the conventional western medicine). The primary endpoint event was a composite endpoint event including cardiovascular death, nonfatal myocardial infarction, and emergency revascularization surgery. Secondary endpoint events were composite endpoint events including readmission for ACS, heart failure, stroke, and other thrombotic events. Adverse events were collected. Cox proportional risk model was used to assess the effect of discriminatory application of Chinese patent medicine on endpoint events, and sensitivity analysis was performed by comparing the results with propensity score matching analysis. Results: A total of 748 female ACS post-PCI patients were included in the analysis, aged (63.2±8.3) years. There were 370 patients in the group of discriminative application of Chinese patent medicines and 378 patients in the conventional treatment group. There were 37 cases (10.0%) and 58 cases (15.3%) of primary endpoint events in the discriminatory application of Chinese patent medicines group and the conventional treatment group, respectively. Cox analysis showed that the risk of primary endpoint in the discriminatory application of Chinese patent medicines group was lower than that in the conventional treatment group after adjusting for confounding factors (adjusted HR=0.62, 95%CI 0.40-0.96, P=0.031). There were 38 (10.3%) and 57 (15.1%) cases of secondary endpoint events in the two groups, respectively. Cox regression analysis showed that the risk of secondary endpoint events in the discriminatory application of Chinese patent medicine group was lower than that in the conventional treatment group after adjusting for confounders (adjusted HR=0.56, 95%CI 0.37-0.87, P=0.001). The results of propensity score matching analysis also showed that Chinese patent medicines based on discriminatory application could reduce the risk of primary endpoint (HR=0.62,95%CI 0.40-0.97,P=0.033) and second endpoint (HR=0.56, 95%CI 0.37-0.87,P=0.009) significantly. There was no significant difference in adverse events between the two groups (12.4% (46/370) vs. 10.3% (39/378), P=0.362). Conclusion: On the basis of conventional western medicine treatment, discriminatory application of Chinese patent medicines can reduce the risk of endpoints in female patients after PCI due to ACS without significant adverse effects.

Development and internal validation of a clinical risk tool to predict chronic postsurgical pain in adults: a prospective multicentre cohort study

Abstract Chronic postsurgical pain (CPSP) is a highly prevalent condition. To improve CPSP management, we aimed to develop and internally validate generalizable point-of-care risk tools for preoperative and postoperative prediction of CPSP 3 months after surgery. A multicentre, prospective, cohort study in adult patients undergoing elective surgery was conducted between May 2021 and May 2023. Prediction models were developed for the primary outcome according to the International Association for the Study of Pain criteria and a secondary threshold-based CPSP outcome. Models were developed with multivariable logistic regression and backward stepwise selection. Internal validation was conducted using bootstrap resampling, and optimism was corrected by shrinkage of predictor weights. Model performance was assessed by discrimination and calibration. Clinical utility was assessed by decision curve analysis. The final cohort included 960 patients, 16.3% experienced CPSP according to the primary outcome and 33.6% according to the secondary outcome. The primary CPSP model included age and presence of other preoperative pain. Predictors in the threshold-based models associated with an increased risk of CPSP included younger age, female sex, preoperative pain in the surgical area, other preoperative pain, orthopedic surgery, minimally invasive surgery, expected surgery duration, and acute postsurgical pain intensity. Optimism-corrected area-under-the-receiver-operating curves for preoperative and postoperative threshold-based models were 0.748 and 0.747, respectively. These models demonstrated good calibration and clinical utility. The primary CPSP model demonstrated fair predictive performance including 2 significant predictors. Derivation of a generalizable risk tool with point-of-care predictors was possible for the threshold-based CPSP models but requires independent validation.

No impact of HIV coinfection on the mortality in patients with hepatitis C virus infection after sustained virological response.

In patients with hepatitis C virus (HCV) chronic infection and advanced liver disease, the impact of human immunodeficiency virus (HIV) coinfection on the clinical outcome after sustained virological response (SVR) has not been sufficiently clarified. The aim of this study was to compare the mortality after SVR of patients bearing HCV chronic infection and advanced liver fibrosis, with and without HIV-coinfection after a prolonged follow-up. This was a prospective multicenter cohort study including individuals with HIV/HCV-coinfection and patients with HCV-monoinfection from Spain, fulfilling: 1) Liver stiffness (LS) ≥9.5 kPa before treatment; 2) SVR with a direct-acting antiviral (DAA) based regimen; 3) LS measurement available at SVR. The main outcome was overall survival. Mortality attributable to liver disease and non-hepatic causes was also assessed. 1,118 patients were included, of whom 676 (60.5%) were living with HIV. The median (Q1-Q3) follow-up was 76 months (57-83). After SVR, 46 (10%) HCV-monoinfected and 74 (11%) HIV/HCV-coinfected patients died. The overall mortality rate (95% CI) was 1.9 (1.6-2.2) per 100 person-years, 1.9 (1.4-2.5) per 100 person-years in patients with HCV-monoinfection and 1.8 (1.6-2.3) per 100 person-years in people living with HIV. In the multivariable analysis, HIV-coinfection was not associated with a shorter survival [0.98 HR (95% confidence interval, CI) = (0.61-1.58), p=0.939]. In patients with HCV chronic infection and advanced fibrosis, HIV-coinfection does not reduce the overall survival after SVR.

Extent and causes of unused medications among patients in rural Ethiopia: a prospective multicenter cohort study

BackgroundMedication waste poses health, economic, and environmental challenges. However, the extent among patients living in rural areas is underexplored. This study assessed the proportion of prescribed medications remaining unused by patients living in rural areas of Ethiopia, and identify the causes thereof and disposal practices.MethodsA prospective multicenter cohort study was conducted in 5 rural health centers in Ethiopia. Patients (≥ 18 years), who received a prescription for acute or chronic medication for pick up from the outpatient pharmacy were included. After 3 months, participants received a house visit by a health employee during which a questionnaire was verbally administered to assess the quantity of unused medication, reason thereof, and disposal practices used. Data were analyzed using descriptive statistics and multivariate logistic regression to identify factors associated with presence of unused medications.ResultsIn total, 178 patients participated. Up to 136 out of 601 (22.6%) dispensed medications ended up unused, mainly antibiotics and analgesics, with an average economic value of $0.37. Of 178 patients, 72 (40.4%) ended up with unused medication, and 15 (8.4%) did not use 80% or more of the prescribed quantity. Early discontinuation of therapy was the main reason (61.8%) for patients’ ending with unused medication. Patients reported to primarily dispose of unused medication either through the toilet (43.6%), household garbage (22.7%), burning (13.6%), or returning it to the pharmacy (2.7%). Medications dispensed to be administered with two or more-unit doses at a time were more likely to remain unused (adjusted OR 1.6 [1.0–3.4]) compared to medications dispensed to be administered one-unit dose.ConclusionA substantial amount of prescribed medications remains unused by patients in rural areas, frequently not properly disposed. Interventions are needed to ensure medications are not wasted and reduce the unwanted consequences.

Comparison of Patient Reported Outcomes between Active surveillance and Immediate Lobectomy in Patients with Low-risk Papillary Thyroid Microcarcinoma: Initial Findings from the KoMPASS cohort.

Patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC) face the decision between thyroid lobectomy and active surveillance (AS). This study aimed to investigate the factors influencing treatment decisions in low-risk PTMC and to compare the quality of life (QoL) according to the treatment plan. The multicenter prospective cohort study comparing AS and thyroid lobectomy was conducted. Clinical characteristics were compared between the AS and Lobectomy groups. QoL questionnaires were administered every 6 months in the initial year and annually thereafter. A total of 927 patients (453 in the AS group and 474 in the Lobectomy group) with low-risk PTMC were included in this study. The mean age was 47.4 ± 12.2 years, and 72.2% of the patients were women. Older age (odd ratio [OR] 1.04, 95% confidence interval [CI] 1.02 - 1.05, p <0.001), smaller tumor size (OR 0.78, 95% CI 0.69 - 0.87, p <0.001), family history of thyroid cancer (OR 1.48, 95% CI 1.03 - 2.12, p = 0.035), prior awareness of AS (OR 1.53, 95% CI 1.16 - 2.02, p = 0.003), and higher income (OR 1.79, 95% CI 1.13 - 2.83, p = 0.013) were significantly associated with a higher likelihood of choosing AS. The median follow-up was 27.3 months (23.9 - 43.9) in the AS group and 28.7 months (20.4 - 44.5) in the Lobectomy group. During the follow-up period, the AS group showed significantly better QoL scores compared to the Lobectomy group (β 0.17, 95% CI 0.02 - 0.33, p = 0.029). Although baseline QoL scores favored the AS group significantly (7.1 ± 1.2 vs. 6.7 ± 1.2, p < 0.001), no significant difference was observed after 12 months (7.2 ± 1.2 vs. 7.1 ± 1.2, p =0.592). This study demonstrated that age, tumor size, family history of thyroid cancer, awareness of AS, and income were associated with patients' treatment choices. Although the overall QoL scores were significantly higher in the AS group, the QoL became similar between the two groups after 12 months.

The relationship between tricuspid annular plane systolic excursion on transesophageal echocardiography and the incidence of postoperative acute kidney injury in patients undergoing coronary artery bypass grafting surgery: a multicenter prospective cohort study

BackgroundTo date, the relationship between the Transesophageal Echocardiography (TEE) monitoring indicator tricuspid annular plane systolic excursion (TAPSE) and the incidence of postoperative acute kidney injury (AKI) in Coronary Artery Bypass Grafting(CABG) patients remains unknown. The main objective of this study was to explore the relationship between the TAPSE and the incidence of AKI in CABG patients.MethodsThis was a multicenter prospective cohort study was conducted between September 2021 and July 2022. Among 266 patients aged at least 18 years who underwent elective CABG, 140 were included.ResultsWe measured TAPSE via M-mode TEE via the mid-esophageal (ME) right ventricle(RV) inflow-outflow view (60°). All echocardiographic measurements were performed three separate times at each time point: T0 (before the start of CABG), T2 (approximately 5 ∼ 10 min after neutralization of protamine) and T3 (before leaving the operating room), and then averaged. Serum creatinine was measured 1 day before and within 7 days after CABG. There was no statistically significant association between the TEE-monitoring indicator TAPSE and the incidence of postoperative AKI in patients who underwent CABG.ConclusionsThe TAPSE was not significantly correlated with postoperative AKI incidence and could not predict the early occurrence of postoperative AKI in CABG patients. TEE needs more evaluation for clinical efficacy of predicting the early occurrence of postoperative AKI in isolated CABG.

Hypogammaglobulinemia and infection risk in myotonic dystrophy type 1.

Hypogammaglobulinemia is a common yet under-recognized feature of myotonic dystrophy type 1 (DM1). The aims of our study were to determine the frequency of immunoglobulin G (IgG) deficiency in our cohort, to examine the association between immunoglobulin levels and cytosine-thymine-guanine (CTG) repeat length in the DMPK gene, and to assess whether IgG levels are associated with an increased risk of infection in DM1 patients. We conducted a single-center, retrospective cross-sectional study of 65 adult patients with DM1 who presented to the Neuromuscular Clinic at Concord Repatriation General Hospital, Sydney, Australia, between January 2002 and January 2022. We systematically collected and analyzed clinical, laboratory, and genetic data for all patients with available serum electrophoresis and/or IgG level results. Forty-one percent of DM1 patients had IgG deficiency despite normal lymphocyte counts, IgA, IgM, and albumin levels. There was an association between CTG repeat expansion size and the degree of IgG deficiency (F = 6.3, p = .02). There was no association between IgG deficiency and frequency of infection in this group (p = .428). IgG deficiency is a frequent occurrence in DM1 patients and is associated with CTG repeat expansion size. Whether hypogammaglobulinemia is associated with increased infection risk in DM1 is unclear. A prospective multicenter cohort study is needed to evaluate this.

Laparoscopic Ultralow Anterior Resection Using a New Articulating Device.

Laparoscopic surgery offers several advantages, but it can be challenging to perform in confined spaces, such as the narrow and deep pelvis, due to poor vision and instrument collisions. Conventional laparoscopic instruments are rigid and straight, which can restrict optimal access to the target organ. Although the use of robotic surgical platforms with flexible wrists has significantly reduced movement restrictions and surgeon fatigue, their high cost remains a barrier to widespread adoption. Recent technological advancements in laparoscopic instruments have led to the development of an articulating flexible hand-held device that enables greater dexterity and easier access to difficult anatomical locations. This technology has the potential to improve surgical outcomes by using multiple degrees of freedom to perform complex surgical procedures with greater precision. The ArtiSential® product line comprises over 30 end-effectors, such as scissors, hooks, and graspers. The benefits of this device are evident throughout the total mesorectal excision, especially when approaching the left lateral side of the mesorectum (the side opposite the surgeon) or the deepest part of the pelvis around the levator ani muscle. The Samsung Medical Center Institutional Review Board approved this study (2022-01-174). A 79-year-old male with rectal cancer located 9 cm from the anal verge underwent an laparoscopic ultralow anterior resection using ArtiSential®. There were no intraoperative complications. The pathologic results showed that the tumor was at pT3N0 stage. The patient was discharged without any complications. The articulating device can be effectively used for laparoscopic surgery, but has some challenges related to the bulky handpiece and learning curve. A multicenter prospective cohort study to compare the outcomes of articulating laparoscopic surgery and robotic surgery for patients with rectal cancer is oncoing (clinicaltrials.gov number: NCT05566249).

Ultrasound-measured quadriceps thickness and mortality in older patients with heart failure

BackgroundUltrasound may be helpful for muscle mass assessment in heart failure (HF). We aimed to determine the feasibility and prognostic implications of ultrasound-measured quadriceps muscle thickness (QMT) in older patients with HF. MethodsThis was a post-hoc analysis of a multicenter prospective cohort study including patients hospitalized for HF aged ≥ 65 years. QMT at rest and during isometric contractions was measured in the supine position using ultrasound before discharge. ResultsThe interobserver agreement for measuring QMT was excellent, with intraclass correlation coefficients (ICCs) of 0.979 (95% confidence interval [CI] 0.963–0.988) at rest and 0.997 (95% CI 0.994–0.998) during isometric contraction. The intra-observer reproducibility was also excellent (ICC >0.92). Of the 595 patients (median age: 81 years, 56% male), median QMT at rest and during contraction were 18.9 mm and 24.9 mm, respectively. The patients were grouped according to sex-specific tertiles of height-adjusted QMT. During the median follow-up of 735 days, 157 deaths occurred, and Kaplan–Meier curve analysis showed that the lowest tertile of the height-adjusted QMT was associated with higher mortality. Cox proportional hazard analysis revealed that thinner height-adjusted QMT was independently associated with higher mortality, even after adjusting for conventional risk factors (per 1 mm/m increase: hazard ratio [HR] 0.94, 95% CI 0.89–0.99, P=0.030 [at rest] and HR 0.94, 95% CI 0.90–0.99, P=0.015 [during isometric contraction]). ConclusionsUltrasound-measured QMT in older patients with HF is feasible, and thinner height-adjusted QMT at rest and during isometric contraction was independently associated with higher mortality.

Predictive Validity of the Work, Osteoarthritis, or Joint Replacement Questionnaire (WORQ) for Return to Work after Total Knee Arthroplasty: A 12-Month Multicenter Prospective Cohort Study

BackgroundAfter total knee arthroplasty (TKA), a minority of working patients are dissatisfied and experience a late or no return to work (RTW). This study aimed to identify whether a pre-defined grouping based on self-reported ability to perform work-related activities at three months post-TKA was associated with the ability to perform work-related activities at six and 12 months and RTW at three, six, and 12 months post-TKA. MethodsA 12-month multicenter prospective cohort study was performed among working TKA patients intending to RTW. The work, osteoarthritis, or joint replacement questionnaire (WORQ) score (range 0 to 100) was used to assess patients’ ability to perform work-related activities. Patients were grouped into early-, intermediate-, and late-recovery groups at three months post-TKA. The median age of the cohort (n = 182) was 59 years [IQR [interquartile range] 55 to 62], and 52% were women. Analyses included Spearman’s correlation tests, and Kaplan-Meier survival analyses. ResultsThe early- (n = 54) and intermediate-recovery groups (n = 68) clinically improved their ability to perform work-related activities at three and 12 months, respectively, while the late-recovery group (n = 60) did not do so until 12 months (rs = 0.6, 0.27, and 0.25, respectively). The early-recovery group returned to work earlier (median 62 [IQR 41 to 90] days) compared to the intermediate- (75 [46 to 115] days) and late-recovery groups (84 [58 to 116] days) and resumed 100 percent of their working hours at six months versus 12 months in the intermediate- and late-recovery groups (rs = 0.37, 0.33, 0.1 at three, six, and 12 months, respectively). ConclusionAt three months post-TKA, the WORQ can be used to distinguish early-, intermediate-, and late-recovery groups, which are associated with the ability to perform work-related activities at six and 12 months post-TKA and RTW at three and six months.

Influence of COMT (rs4680) and OPRM1 (rs1799971) on Cancer Pain, Opioid Dose, and Adverse Effects.

Background: The influence of pharmacogenomics on opioid response, particularly with COMT (rs4680) and OPRM1 (rs1799971) variants, has been studied individually and in combination. However, most studies are in a noncancer context and not all their possible variant combinations have been examined. Objectives: This study examined COMT (rs4680) and OPRM1 (rs1799971), and their allele combinations, in advanced cancer to examine associations with pain scores, opioid dose, and adverse effects. Setting/Subjects: This multicenter prospective cohort study recruited patients receiving opioids for advanced cancer pain in Melbourne, Australia. Clinical data (demographics, opioids), validated instruments (pain and adverse effects), and blood (DNA) were collected. Descriptive analyses were used. Univariate and multivariate logistic regression analyses were used to evaluate associations between clinical outcomes (opioid dose, pain, adverse effects) and genotypes of interest. Results: Fifty-four participants were recruited to the study. Those with COMT A allele required lower opioid doses [130 mg (interquartile range [IQR] 67.5,230) versus 180 mg (IQR 55,322.5), p = 0.047] and experienced greater adverse effects [sickness response aOR (adjusted odds ratio) 7.1 (95% CI 1.51,33.41), p = 0.01]. Those with the COMT GG/OPRM1 G allele combination required higher opioid doses [322.5 mg (IQR 264,360) versus 125 mg (65,225), (p = 0.04)]. Those with COMT AG/OPRM1 AA experienced higher average pain [aOR 1.55 (95% CI 1.03, 2.33), p = 0.04] and moderate-severe nausea [aOR 5.47 (95% CI 1.35, 22.21), p = 0.02] but reduced drowsiness [aOR 0.25 (95% CI 0.06, 1.02), p = 0.05]. Conclusions: Patients with cancer with the COMT alternate (A) allele have greater sickness response adverse effects, which may be responsible for the lower opioid doses observed. Significant results of two new COMT/OPRM1 genotype combinations are presented that have not previously been studied, with plausible phenotype descriptions suggested.

Increased plasma AACT level as an indicator of poor prognosis in patients hospitalised with community-acquired pneumonia: a multicentre prospective cohort study

Background and objectiveCommunity-acquired pneumonia (CAP) is a common respiratory disease that frequently requires hospitalisation, and is a significant cause of death worldwide. This study aimed to evaluate the usefulness of alpha-1-antichymotrypsin (AACT) as a diagnostic and prognostic biomarker of CAP.MethodsWe conducted a multicentre prospective cohort study in patients hospitalised with CAP. Plasma AACT levels were measured using a quantitative enzyme-linked immunosorbent assay. Receiver-operating characteristic (ROC) curves and Cox proportional hazards regression were used to assess the association between plasma AACT levels and CAP diagnosis and prognosis.ResultsA total of 274 patients with CAP were enrolled in the study. AACT levels were elevated in patients with CAP, especially those with severe CAP and non-survivors. The area under the curve (AUC) of AACT and CRP for diagnosing CAP was 0.755 and 0.843. Cox regression showed that CURB-65 and AACT levels were independent predictors of 30-day mortality. ROC curves showed that plasma AACT levels had the highest accuracy for predicting acute respiratory distress syndrome (ARDS), with an AUC of 0.862. Combining AACT with Pneumonia Severity Index and CURB-65 significantly improved their predictive accuracy for predicting 30-day mortality.ConclusionPlasma AACT levels are elevated in patients with CAP, but plasma AACT level is inferior to the C-reactive protein level for diagnosing CAP. The AACT level can reliably predict the occurrence of ARDS and 30-day mortality in patients with CAP.

Preoperative measures of pain at rest and movement-evoked pain in knee arthroplasty: Associations with pain and function outcome trajectories from a prospective multicentre longitudinal cohort study.

The study of pain at rest (PAR) and movement-evoked pain (MEP) in persons with musculoskeletal pain has received substantial attention. Despite strong interest, relatively little attention has been directed to the psychometric development of these constructs. Our purpose was to explore the relationship between PAR and MEP and to examine the prognostic utility of these measures in persons with knee arthroplasty. We used prospectively collected data from persons scheduled for knee arthroplasty who had moderate to high levels of pain catastrophizing. Preoperative latent variables for PAR and MEP were developed and used to determine if they were associated with a binary latent variable of good versus poor pain and function outcome trajectories. Factor correlations were used to determine the extent to which the variance for PAR and MEP was overlapping. PAR and MEP are significant predictors of good versus poor pain and function classes. Odds ratios ranged from 1.21 to 1.64 (p < 0.001) indicating a significant increase in the likelihood of poor outcome. Correlation between PAR and MEP latent variables was high (r = 0.89; 95% CI: 0.86-0.92) indicating substantially overlapping variance. PAR and MEP, as defined in our study, can be used to make prognostic judgements regarding risk of poor postoperative outcome trajectory following knee arthroplasty. However, PAR and MEP showed substantially overlapping variance indicating that measurements of both are not necessary when making prognostic assessments. Preoperative PAR and MEP latent variables, as defined in our study, had prognostic significance for 1 year pain and function outcome trajectories. PAR and MEP latent variables had substantially overlapping variance which suggested that only one is needed to make prognostic judgements. The prognostic significance of PAR and MEP as well as their substantially overlapping variance is new to the field prognostic research in knee arthroplasty.

EP530 - Facial Features after Weight Loss (FACE-WL) Study: A Protocol for a 1- year Multicentre Longitudinal Prospective Study

Abstract Introduction Obesity is a pressing public health concern and various effective interventions have been implemented for weight loss in patients with obesity. The effect of weight loss is not restricted to only limbs and trunks but the changes in the anatomy of the face and facial structure have received limited attention. In view of the paucity of studies examining facial feature changes after weight loss, the FACE-WL study aims to examine the facial changes for patients post weight loss. Methods The FACE-WL study is a multicentre 1-year longitudinal prospective cohort study, within a real-world routine clinical care setting aiming to recruit 500 patients after losing weight via either conservative, medical or surgical management. Photos of patients’ faces would be taken pre-intervention (T0) and post intervention after 3 (T1), 6 (T2), 9 (T3) and 12 months (T4), coincide with normal follow-up care visits. Photographs will be analysed using the Emotrics software, which automatically identifies facial landmarks and computes differences in position. Participants’ sociodemographic data, health-related quality of life, clinical outcome, and surgical data if applicable will be completed by the study team at the baseline visit and subsequent follow-up visit. Ethics And Dissemination Its results will be disseminated through manuscripts in clinical/academic journals and presentations at professional conferences, and through participant and stakeholder communications.

Association of the combined stereotactic radiosurgery and embolization strategy and long-term outcomes in brain arteriovenous malformations with a volume >10 ml: A nationwide multicenter observational prospective cohort study

BackgroundTo assess the long-term outcome of large brain arteriovenous malformations (AVMs) (volume > 10 ml) underwent combined embolization and stereotactic radiosurgery (E+SRS) versus SRS alone. MethodsPatients were recruited from a nationwide multicenter prospective collaboration registry (MATCH study, August 2011–August 2021) and categorized into E+SRS and SRS alone cohorts. Propensity score-matched survival analysis was employed to control for potential confounding variables. The primary outcome was a composite event of non-fatal hemorrhagic stroke or death. Secondary outcomes were favorable patient outcomes, AVM obliteration, favorable neurological outcomes, seizure, worsened mRS score, radiation-induced changes (RIC), and embolization complications. Furthermore, the efficacy of distinct embolization strategies was evaluated. Hazard ratios (HRs) were computed utilizing Cox proportional hazard models. ResultsAmong 1063 AVMs who underwent SRS with or without prior embolization, 176 patients met the enrollment criteria. Following propensity score matching, the final analysis encompassed 98 patients (49 pairs). Median (interquartile range) follow-up duration for primary outcomes spanned 5.4 (2.7–8.4) years. Overall, the E+SRS strategy demonstrated a trend toward reduced incidence of primary outcomes compared to the SRS alone strategy (1.44 vs 2.37 per 100 patient-years; HR, 0.58 [95 % CI, 0.17–1.93]). Regardless of embolization degree or strategy, stratified analyses further consistently revealed a similar trend, albeit without achieving statistical significance. Secondary outcomes generally exhibited equivalence, but the combined approach showed potential superiority in most measures. ConclusionsThis study suggests a trend toward lower long-term non-fatal hemorrhagic stroke or death risks with the E+SRS strategy when compared to SRS alone in large AVMs (volume > 10 ml).

Assessment of long-term psychosocial outcomes in N-methyl-D-aspartate receptor encephalitis – the SAPIENCE study protocol

BackgroundN-methyl-D-aspartate-receptor (NMDAR) encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms during the acute phase. Despite good functional neurological recovery, most patients continue to experience cognitive, psychiatric, psychological, and social impairments years after the acute phase. However, the precise nature and evolving patterns over time of these long-term consequences remain unclear, and their implications for the well-being and quality of life of predominantly young patients have yet to be thoroughly examined.MethodsSAPIENCE is a European multi-center (n = 3) prospective observational cohort study studying the long-term cognitive, psychiatric, psychological, and social outcome in patients with NMDAR encephalitis. The study consists of three interconnected levels. Level 1 comprises a qualitative interview and focus groups with patients and their caregivers. Level 2 consists of a condensed form of the interview, standardized questionnaires, and a detailed neuropsychological examination of patients. Level 3 involves an online survey that will be open to patients world-wide and explores patient-reported outcomes (PROMs), and patient-reported experiences (PREMs) in association with clinical and cognitive outcomes. Levels 1 to 3 will progressively contribute developing of structured interviews, survey questions, and treatment guidelines by informing one another.DiscussionSAPIENCE is an in-depth study of the long-term effects of NMDAR encephalitis and bridges the gap between standardized assessments and individual patient experiences, intending to improve patient care and to increase awareness of the psychosocial long-term consequences of the disease. Through collaboration of experts in clinical neurology and social and health psychology across Europe, SAPIENCE aims to create online assessment tools and formulate guidelines for patient-centered post-acute care that will help enhance the quality of life for patients and caregivers.

Respiratory Drive, Effort, and Lung-Distending Pressure during Transitioning from Controlled to Spontaneous Assisted Ventilation in Patients with ARDS: A Multicenter Prospective Cohort Study.

Objectives: To investigate the impact of patient characteristics and treatment factors on excessive respiratory drive, effort, and lung-distending pressure during transitioning from controlled to spontaneous assisted ventilation in patients with acute respiratory distress syndrome (ARDS). Methods: Multicenter cohort observational study of patients with ARDS at four academic intensive care units. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from occlusion of airway pressure (∆Pocc) (PmusΔPocc), and dynamic transpulmonary driving pressure (ΔPL,dyn) were measured at the first transition to assisted spontaneous breathing. Results: A total of 4171 breaths were analyzed in 48 patients. P0.1 was >3.5 cmH2O in 10%, EAdiPEAK > 15 µV in 29%, ∆PmusEAdi > 15 cmH2O in 28%, and ΔPL,dyn > 15 cmH2O in 60% of the studied breaths. COVID-19 etiology of ARDS was the strongest independent risk factor for a higher proportion of breaths with excessive respiratory drive (RR 3.00 [2.43-3.71], p < 0.0001), inspiratory effort (RR 1.84 [1.58-2.15], p < 0.0001), and transpulmonary driving pressure (RR 1.48 [1.36-1.62], p < 0.0001). The P/F ratio at ICU admission, days of deep sedation, and dose of steroids were additional risk factors for vigorous inspiratory effort. Age and dose of steroids were risk factors for high transpulmonary driving pressure. Days of deep sedation (aHR 1.15 [1.07-1.24], p = 0.0002) and COVID-19 diagnosis (aHR 6.96 [1-48.5], p = 0.05) of ARDS were independently associated with composite outcome of transitioning from light to deep sedation (RASS from 0/-3 to -4/-5) or return to controlled ventilation within 48 h of spontaneous assisted breathing. Conclusions: This study identified that specific patient characteristics, including age, COVID-19-related ARDS, and P/F ratio, along with treatment factors such as the duration of deep sedation and the dosage of steroids, are independently associated with an increased likelihood of assisted breaths reaching potentially harmful thresholds of drive, effort, and lung-distending pressure during the initial transition to spontaneous assisted breathing. It is noteworthy that patients who were subjected to prolonged deep sedation under controlled mechanical ventilation, as well as those with COVID-19, were more susceptible to failing the transition from controlled to assisted breathing.

Sex and gender differences in health-related quality of life in individuals treated with incremental and conventional hemodialysis

Abstract Background Women treated with hemodialysis report lower health-related quality of life (HRQoL) compared to men. Whether this is related to sex- (biological) (e.g., under-dialysis due to body composition differences) or gender-specific (sociocultural) factors (e.g., greater domestic/caregiver responsibilities for women) is unknown. We examined the association between sex assigned at birth (SAAB), gender score, and HRQoL in individuals initiating conventional and incremental hemodialysis. Methods In this prospective multi-centre cohort study, incident adult hemodialysis patients were recruited 1 June 2020-30 April 2022 in Alberta, Canada. SAAB and gender identity were self-reported. Gender-related characteristics were assessed by self-administered questionnaire to derive a composite measure of gender. The primary outcome was change in Kidney Disease Quality of Life-36 physical (PCS) and mental (MCS) component scores after 3-months of hemodialysis. Results Sixty participants were enrolled (conventional hemodialysis: 14 female, 19 male; incremental hemodialysis: 12 female, 15 male). PCS improved from baseline with conventional (p=0.01) but not incremental (p=0.52) hemodialysis in females. No difference in MCS was observed by hemodialysis type in females. Gender score was not associated with changes in PCS in females, irrespective of hemodialysis type. Higher gender score was associated with increased MCS with incremental (p=0.04), but not conventional (p=0.14), hemodialysis (p=0.03 conventional vs incremental). No change in PCS or MCS in males, irrespective of hemodialysis type or gender score. Conclusion In this exploratory study, conventional hemodialysis was associated with improved PCS in females, while incremental hemodialysis was associated with improved MCS in females with more roles and responsibilities traditionally ascribed to women. Large prospective studies are required to further investigate these relationships.

Cut-offs for relapse detection in men with stage I testicular germ cell tumors during active surveillance within a prospective multicentre cohort study using either raw or housekeeper normalized miR-371a-3p serum levels

PurposeMiR-371a-3p represents a novel liquid biomarker that detects all histologies of germ-cell tumors (GCT) except teratoma. However, it is currently unclear whether miR-371a-3p results obtained directly from RT-PCR (raw Cq) or normalized for housekeeper genes and transformed into the relative quantity (RQ) value should be used and at what cut-off level. The purpose of this research was to evaluate, which values should be used, and a potential cut-off level for relapse-detection to inform subsequent studies. Materials and MethodsWe applied a CE-certified qRT-PCR test to measure miR-371a-3p at each follow-up visit during active surveillance in 34 men with stage I testicular GCT. MiR-371a-3p levels were calculated by the ΔΔ method. ResultsAbout 18 Patients had pure seminoma and 16 had mixed or nonseminomatous testicular GCT. Recurrences were detected in 10 patients and were correctly identified by both raw and housekeeper-normalized miR-371a-3p serum levels. The raw Cq, with a cut-off value of <28, resulted in only 1 false positive (3%), whereas RQ, with a cut-off value of >15, produced 6 false positive results (17%). Most of these false positive results normalized in subsequent measurements. The RQ approach detected recurrence in 1 patient 6 months earlier than the raw Cq approach. ConclusionOur preliminary data suggest that this CE-certified assay, using previously suggested cut-off values, is a promising method for detecting disease recurrence, provided a confirmatory second test is conducted to identify false positive results. To avoid unnecessary scans or overtreatment, we are currently validating this assay and cut-offs in a prospective cohort study.