Single-center Prospective Observational Cohort Research Articles

Effects of Biologics on Temporomandibular Joint Inflammation in Juvenile Idiopathic Arthritis.

This prospective study investigates the efficacy of biologics in combination with methotrexate or leflunomide on juvenile idiopathic arthritis (JIA)- related temporomandibular joint (TMJ) arthritis measured by magnetic resonance imaging (MRI)-based inflammation score and deformity score. A prospective single center observational cohort study of 18 consecutive patients were performed between September 2018- April 2023. Inclusion criteria were: 1) Diagnosis of JIA, 2) MRI-verified TMJ arthritis leading to treatment with tumor necrosis factor inhibitor (TNFi), 3) MRI at 6 and 24 months after treatment initiation, 4) clinical follow-up contemporary with the MRI by a pediatric rheumatologist and an orthodontist. We included 18 patients (89% females). At time of first MRI median age was 13.2 years (IQR 11.3-16.9), median disease duration was 7.8 years (IQR 3.4-11.1) and 4 received MTX/leflunomide. During the observation period, significant improvements were observed in TMJ movement pain (p=0.01), morning stiffness (p=0.004), opening capacity (p=0.03) and maximal incisal opening (p=0.006). The inflammation score decreased significantly from median 2 (IQR 1-3) at baseline to median 1(IQR 0-2) at 24 months, p=0.009. In 17 out of 36 TMJs (48%), the deformity score improved or remained stable and no significant increase in the median score was observed. This is the first prospective observational study with evidence to support that the orofacial signs, symptoms and MRI-derived inflammation score in TMJ arthritis can be reduced by treatment with TNFi.

Comparison of ROTEM® Delta and ROTEM® Sigma transfusion algorithm performance in thoracic aortic surgery: a single-centre prospective observational cohort study

BackgroundThromboelastometry plays a key role in many transfusion algorithms. ROTEM® Sigma is the fully automated successor of ROTEM® Delta. Compatibility with current ROTEM® Delta-based algorithms remains uncertain. This study compares ROTEM® Delta with ROTEM® Sigma in patients undergoing thoracic aortic surgery. MethodsThree ROTEM® measurements in duplicate (one Delta and one Sigma) per patient were performed during aortic surgery. The primary outcome was the percentage of patients who would have received a different haemostatic intervention after protamine reversal based on the institutional ROTEM®-guided transfusion algorithm (‘deviation’). A 10% deviation was deemed acceptable. Secondary outcomes were differences in numerical values assessed by Passing–Bablok regressions, Bland–Altman plots, and correlations with conventional coagulation tests. ResultsOf 111 patients, 102 had matched post-protamine ROTEM® measurements. There were 43 algorithm deviations. Most deviations (29) were attributable to conflicting advice on CT EXTEM-based plasma or prothrombin complex concentrate (PCC) administration; in 25 patients, Delta results advised the administration of plasma or PCC, whereas Sigma did not, and vice versa in four patients. Deviations on additional protamine, fibrinogen concentrate, or platelet administration were acceptable. All numerical ROTEM® variables examined passed the criteria for equivalence, except for A10 FIBTEM at baseline and A10 EXTEM in heparinised and post-protamine samples, which would not have led to clinical consequences. Correlations with conventional coagulation tests were similar or better for Sigma compared with Delta. ConclusionsROTEM® Sigma can be used with existing ROTEM-guided transfusion algorithms in cardiothoracic surgery except for the advice for administration of plasma or PCC. Clinical Trial RegistrationNetherlands trial register NL8273.

INTEGRATING A VIRTUAL REALITY MASK IN FUNCTIONAL UROLOGICAL SURGERIES UNDER LOCAL ANESTHESIA: A PROSPECTIVE COHORT STUDY ON UTILITY AND SATISFACTION

OBJECTIVESTo evaluate the safety and efficacy of a virtual reality (VR) mask as a distraction tool during minimally invasive functional urological interventions as part of the local anesthesia protocol. METHODSThis is a single-centre prospective observational pilot cohort study which included all consecutive patients undergoing intradetrusor botulinum toxin injection, sacral neuromodulation, and urethral bulking agent injection with combined anesthetic protocol composed by local anesthesia and a VR mask (Hypno VRTM virtual reality mask, Strasbourg, France). Preoperative and postoperative evaluation included the State-Trait Anxiety Inventory (STAI) index. Intraoperatively, a 4-point Likert anxiety rating scale and a visual analog scale (VAS) pain score were assessed. Vital signs were measured preoperative and intraoperatively. Postoperatively, two questionnaires exploring patient satisfaction were administered. The evaluated outcomes were the tolerability of the device and patient’s reported intraoperative pain and anxiety. RESULTSThirty-nine patients were included. Mean age was 64 years. Eleven patients (28%) were affected by neurological conditions. Two patients experienced subjective discomfort. Preoperative and intraoperative mean arterial pressure was 105 and 111 mmHg (p=0.01), respectively. Preoperative and intraoperative mean heart rate was 72 and 75 bpm (p=0.12), respectively. Preoperative and postoperative STAI index were 34.8+-10 and 32.8+-10.3 (p=0.88). Mean Likert anxiety scale value was 2.2+-1.1, mean intraoperative VAS score was 5.3+-2.5. Thirty-four (87%) patients declared themselves satisfied with the surgical procedure and 36 (92.3%) patients would have recommended the same procedure to a relative. CONCLUSIONSVirtual reality mask may play a role in reducing pain and anxiety in minimally-invasive functional urological interventions.

Adnexal Masses in Pregnancy: A Single-Centre Prospective Observational Cohort Study

Objective: To prospectively determine the nature of adnexal masses diagnosed during pregnancy and investigate whether ultrasound was a reliable means of assessing these. Methods: A single-centre prospective observational cohort study was conducted in a large tertiary referral hospital in London. Pregnant women with an adnexal mass detected at or prior to the 12-week routine ultrasound received a detailed ultrasound by a level II ultrasound practitioner at the time of detection; at 12 weeks; 20 weeks; and 6 weeks postpartum. The following outcomes were recorded: subjective impression of the mass; International Ovarian Tumor Analysis simple rules classification; resolution and intervention rate; and the incidence of complications related to the mass. Results: A total of 28,683 pregnant patients were scanned and an adnexal masses was detected in 277 patients, yielding an incidence of 1%. 274 participants were included in the analysis. Subjective impression was as follows: simple 75.9%; dermoid 29.1%; endometrioma 6.6%; haemorrhagic 3.3%; para-ovarian 2.6%; torted simple 0.7%; decidualized endometrioma 0.4%; fibroma 0.4%; theca luteal 0.4%; and borderline ovarian tumour: 0.7%. There was a significant reduction in the volume at each scan (p < 0.0001). Approximately 74.2% of the masses resolved spontaneously. Surgery was performed in 14/274: 2 antenatally, 6 at caesarean section, and 6 postpartum. In 5/247 (2%), there were complications due to the mass. Using IOTA simple rules, 272/274 (99.3%) (p < 0.0001) were classifiable. Only 1/274 (0.4%) had malignant features as per IOTA (p = 0.05). As there were no confirmed malignancies, the accuracy of IOTA simple rules could not be calculated. Conclusions: Adnexal masses in pregnancy are uncommon and the majority spontaneously resolve. Malignancy is rare, as are complications. In the absence of concerns regarding malignancy or cyst accident, there is no need for additional monitoring of these masses during pregnancy.

Does patient activation matter? An examination of the relationships between patient activation and healthcare use in older adults with mild frailty after discharge from an emergency department.

ObjectivePatient engagement, as measured by the Patient Activation Measure (PAM®), has been used to assess patients' ability to manage their own care. This study aimed to determine whether the PAM® could predict healthcare use in older adults aged >70years, living independently in the community with mild frailty, within 30days after emergency department (ED) discharge.MethodsA prospective single-centre observational cohort study was completed including older adults who presented to an ED. The 13-item PAM® and selected International Consortium for Health Outcomes Measures were completed prior to ED discharge.ResultsTwo hundred patients were recruited with a mean age of 84.8years (s.d. 6.9). The mean PAM® score was 58.6 (s.d. 13.3), with 12.5% at Level 1 (n=25), 40% at Level 2 (n=80), 34.5% at Level 3 (n=69) and 13.0% at Level 4 (n=26). The PAM® level was significantly associated with ED presentations in the past 6months (P=0.030). The PAM® level did not predict healthcare use within 30days of discharge consisting of time until ED representation (P=0.557), number of ED representations (P=0.560), number of hospital admissions (P=0.499), length of stay in hospital (P=0.254) and number of post-discharge contacts (P=0.667).ConclusionsOverall, the PAM® did not predict prospective short-term healthcare use. However, the PAM® was significantly associated with 6-month previous ED use. With more than 50% of patients at Level 1 or 2, indicating lower capacity for self-management, tailored interventions are required to assist mildly frail patients to manage discharge care plans and engage in preventative strategies.

Diagnostic Performance of Serum Leucine-Rich Alpha-2-Glycoprotein 1 in Pediatric Acute Appendicitis: A Prospective Validation Study.

Introduction: Leucine-rich alpha-2-glycoprotein 1(LRG-1) is a human protein that has shown potential usefulness as a biomarker for diagnosing pediatric acute appendicitis (PAA). This study aims to validate the diagnostic performance of serum LRG-1 in PAA. Material and Methods: This work is a subgroup analysis from BIDIAP (BIomarkers for DIagnosing Appendicitis in Pediatrics), a prospective single-center observational cohort, to validate serum LRG-1 as a diagnostic tool in PAA. This analysis included 200 patients, divided into three groups: (1) healthy patients undergoing major outpatient surgery (n = 56), (2) patients with non-surgical abdominal pain (n = 52), and (3) patients with a confirmed diagnosis of PAA (n = 92). Patients in group 3 were divided into complicated and uncomplicated PAA. In all patients, a serum sample was obtained during recruitment, and LRG-1 concentration was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). Comparative statistical analyses were performed using the Mann-Whitney U, Kruskal-Wallis, and Fisher's exact tests. The area under the receiver operating characteristic curves (AUC) was calculated for all pertinent analyses. Results: Serum LRG-1 values, expressed as median (interquartile range) were 23,145 (18,246-27,453) ng/mL in group 1, 27,655 (21,151-38,795) ng/mL in group 2 and 40,409 (32,631-53,655) ng/mL in group 3 (p < 0.0001). Concerning the type of appendicitis, the serum LRG-1 values obtained were 38,686 (31,804-48,816) ng/mL in the uncomplicated PAA group and 51,857 (34,013-64,202) ng/mL in the complicated PAA group (p = 0.02). The area under the curve (AUC) obtained (group 2 vs. 3) was 0.75 (95% CI 0.67-0.84). For the discrimination between complicated and uncomplicated PAA, the AUC obtained was 0.66 (95% CI 0.52-0.79). Conclusions: This work establishes normative health ranges for serum LRG-1 values in the pediatric population and shows that serum LRG-1 could be a potentially helpful tool for diagnosing PAA in the future. Future prospective multicenter studies, with the parallel evaluation of urinary and salivary LRG-1, are necessary to assess the implementability of this molecule in actual clinical practice.

Factors associated with difficult intravenous access in the paediatric emergency department: A prospective cohort study.

Although it is the most performed invasive procedure, peripheral intravenous catheter (PIVC) insertion in children can be difficult. The primary objective of the study was to identify the factors associated with difficult intravenous access (DIVA) in the paediatric ED, including patient, proceduralist and situational factors. This was a single-centre prospective observational cohort study conducted over 28 consecutive days. Research assistants observed PIVC insertion attempts for children under 16 years of age and recorded data for variables relating to the patient, proceduralist and event. Univariate logistic regression modelling was performed to identify factors associated with DIVA, defined as unsuccessful PIVC insertion on the first attempt. A total of 134 participants were recruited; 66 were male (49%) with a median age of 5.7 years. Fifty-two (39%) were classified as having DIVA. There was a total of 207 PIVC insertion attempts with two or more attempts needed for 48 children (36%). Patient factors associated with DIVA included age of 3 years or less and limited vein options. Proceduralist factors included gestalt of 50% or less chance of success, use of a larger gauge (smaller bore) PIVC and less PIVC insertion experience. Situational factors included a combative child, higher pain score and loud ambient noise. The present study identified multiple patient, proceduralist and situational factors that were associated with DIVA in the paediatric ED. Future studies should explore the development and implementation of a package to address DIVA in children, with the patient-centred goals of reducing pain and improving success.

Effect of preoperative frailty on postoperative infectious complications and prognosis in patients with colorectal cancer: a propensity score matching study

BackgroundFew studies have explored the impact of preoperative frailty on infectious complications in patients with a diagnosis of colorectal cancer (CRC). Therefore, this study aimed to investigate the effect of preoperative frailty on postoperative infectious complications and prognosis in patients with CRC using propensity score matching (PSM).MethodsThis prospective single-centre observational cohort study included 245 patients who underwent CRC surgery at the Department of Gastrointestinal Surgery, The Affiliated Lianyungang Hospital of Xuzhou Medical University between August 2021 to May 2023. Patients were categorised into two groups: frail and non-frail. They were matched for confounders and 1:1 closest matching was performed using PSM. Rates of infectious complications, intensive care unit (ICU) admission, 30-day mortality, and 90-day mortality, as well as postoperative length of hospital stay, total length of hospital stay, and hospital costs, were compared between the two groups. Binary logistic regression using data following PSM to explore independent factors for relevant outcome measures.ResultsAfter PSM, each confounding factor was evenly distributed between groups, and 75 pairs of patients were successfully matched. The incidence of intra-abdominal infectious complications was significantly higher in the frail group than in the non-frail group (10.7% vs. 1.3%, P < 0.05). There were no significant differences in ICU admission rate, postoperative length of hospital stay, total length of hospital stay, hospital costs, 30-day mortality rate, or 90-day mortality rate between the two groups (P > 0.05). Our logistic regression analysis result showed that preoperative frailty (OR = 12.014; 95% CI: 1.334–108.197; P = 0.027) was an independent factor for intra-abdominal infection.ConclusionsThe presence of preoperative frailty elevated the risk of postoperative intra-abdominal infectious complications in patients undergoing CRC surgery. Therefore, medical staff should assess preoperative frailty in patients with CRC early and provide targeted prehabilitation interventions.

Tackling efficiency in a high demand orthopaedic clinic.

Surgical outpatient clinics continuously face challenges in delivering efficient and effective care. An expanding population and chronic staff shortages makes sustainability critical. The primary objective of this study was to identify modifiable factors contributing to longer wait times in an orthopaedic outpatient clinic. A single-centre prospective observational cohort study was conducted at Western Australia's state trauma centre. Over a four-week period, clinicians completed forms identifying delays in clinic, and clinic numbers were captured through an electronic booking system. Data was analysed using SPSS v27. Face-to-face (FTF) and telehealth (TH) clinic volumes grew by 18.9% and 361.1% respectively between 2018 and 2022. For the study period, 754 forms were completed for attending clinic patients. This captured 42.4% and 96.8% of FTF and TH actual attendance. The average wait time for doctor consultation was 63.9 min. Wait times significantly reduced when x-rays were performed prior to clinic (P < 0.001), and when an unaccredited registrar held the on-call phone (P < 0.001). Trauma clinics ran overtime in 95% of cases compared to elective clinics in which 25% ran overtime. The golden staffing ratio was one doctor for 13 patients. TH experienced few delays related to technological fault. This study demonstrates that clinic volume continues to rise. It highlights the demand for adequate staffing and identifies several modifiable factors that influence clinic efficiency. It demonstrates the growth of TH as an alternative modality for outpatient surgical services and its potential for future expansion.

Can Untrained Patients Perform Their Own Skin and Soft Tissue Ultrasound Examination by Teleguidance?

Objectives: This pilot study aims to determine if patients untrained in performing ultrasound can self-scan to obtain images under remote clinician teleguidance during a simulated telehealth encounter. This study also seeks to describe the patients’ comfort level and barriers to performing an ultrasound examination on themselves using a handheld ultrasound device. Methods: This was a single center prospective observational cohort study conducted over a 4-month period in 2021. Patients were eligible if they had no prior training in the use of ultrasound and in the use of teleguidance. They voluntarily consented to participate at a single ambulatory internal medicine clinic. Results: 20 participants were enrolled and underwent teleguidance to ultrasound their own skin and soft tissues at the antecubital fossae. Six second video clips were evaluated by 2 subject matter experts using the Point of Care Ultrasound Image Quality scale. A score &gt;7 was considered adequate for diagnostic interpretation. The average score was 10.15/14, with a minimum score of 5/14, and maximum score of 14/14 and a standard deviation (SD) of 2.39 using a two tailed Z-score. Setting alpha at 0.05 the 95% CI was (5.47-14.83). Conclusion: In a pilot study of 20 participants with no ultrasound experience, untrained healthy volunteers were able to perform technically acceptable and interpretable ultrasound scans using teleguidance by a trained clinician.

Drug utilization pattern of analgesics after a surgical procedure in a tertiary care hospital: a prospective observational single centre cohort study

Background: the study aimed to understand the prescription pattern of analgesics used in the post-operative period after a general surgical procedure in a tertiary care hospital in India and estimate the severity of post-operative pain up to 48 hours. Such a study was not done in this institute of recent hence it was carried out. Methods: 266 adults of either gender were recruited and prescription pattern analyzed over a period of 1 year beginning January 2021 to December 2021 from the post-operative general surgery wards of a tertiary care hospital in India. Patient interview and records were used to collect data. Follow ups at 4, 24 and 48 hours were undertaken to assess pain according to the visual analogue scale (VAS) that was analyzed using the Friedman’s test followed by the post hoc Dunn’s test. Results: an average of 1.52±0.58 analgesics were prescribed per patient. Paracetamol was most commonly used followed by tramadol and diclofenac. All analgesics prescribed were a part of the national list of essential medicines. Effective pain management is feasible as seen by the significant (p&lt;0.0001) reduction in average pain score from 4.75±1.35 to 3.05±1.18 at 24 hours and further to 2.16±1.04 at 48 hours. Conclusions: Use of analgesics prescribed from a standardized list is effective in majority of patients.

Sarcopenia in patients following stroke: Prevalence and associated factors

BackgroundThis study aimed to investigate the prevalence and associated factors of sarcopenia in patients following stroke during acute hospitalisation. MethodsThis single-centre prospective observational cohort study assessed skeletal muscle mass using bioelectrical impedance analysis and muscle strength of patients with acute stroke at hospital discharge. Sarcopenia was diagnosed according to the AWGS-2019 criteria. Multiple logistic regression analyses were performed to identify associated factors of post stroke sarcopenia. ResultsA total of 286 participants (32% female; median age, 72 years) were included in this study. The prevalence of post-stroke sarcopenia was 32.5% (n = 93). In multiple logistic regression analysis, age (adjusted odds ratio [aOR]: 1.10; 95% confidence interval [CI]: 1.05–1.05), National Institute of Health Stroke Scale (aOR: 1.15; 95% CI: 1.04–1.27), body mass index (BMI) (aOR: 0.73; 95% CI: 0.64–0.84) and Functional Oral Intake Scale (aOR: 0.67; 95% CI: 0.51–0.89) were independently associated with post-stroke sarcopenia during acute hospitalisation. ConclusionApproximately one-third of acute stroke patients were diagnosed with sarcopenia at hospital discharge, and older age, severe stroke, low BMI, and poor swallowing function are associated with sarcopenia following stroke during acute hospitalisation.

SARS-CoV-2 infection outcomes associated with the Delta variant: A prospective cohort study.

It is well established that fully vaccinated (≥2 doses) individuals may develop COVID-19. However, little is known about the specific prevalence of post-COVID-19 conditions associated with the Delta variant or the effect of vaccination on post-acute outcomes of COVID-19. In addition, how Delta variant infection severity compares in fully vaccinated individuals versus in those unvaccinated is unknown. This prospective single-centre observational cohort study assessed adults with SARS-CoV-2 proven infection from August 1 to November 1, 2021. Study participants were enrolled in the Biobanque Québécoise de la COVID-19. Data on demographics, comorbidities, and severity of COVID-19 were collected. Simple and multiple logistic regressions were used to identify risk factors for post-COVID-19 conditions. Among the 395 individuals who were interviewed by phone, 138 (39.4%) agreed to participate. Of the 138 participants, 62.8% were Delta-associated breakthrough infections that occurred in fully vaccinated individuals and 37.1% in unvaccinated individuals. The majority (93.5%) had a history of mild COVID-19 illness. The prevalence of Delta-variant-associated post-COVID-19 conditions was similar in both vaccinated (61.4%) and unvaccinated (51.4%) groups (p = 0.347). The number of symptoms during acute infection was an independent risk factor for post-COVID-19 conditions. This study is the first to describe the incidence of Delta-associated post-COVID-19 condition. In this study, COVID-19 vaccination was not associated with decreased post-COVID-19 conditions in patients with breakthrough Delta infection. These findings have important implications for provincial services planning and underscore the need to develop alternative strategies to prevent post-COVID-19 conditions.

Clinical effect of total thoracoscopic mitral valve surgery combined with atrial fibrillation radiofrequency ablation in patients with different left atrium diameter-a single center prospective observational cohort study.

Mitral valve surgery combined with atrial fibrillation (AF) radiofrequency ablation (AFRA) is recommended as the first-line strategy for valvular disease-related AF. There are relatively few reports on the effect of AFRA combined with total thoracoscopic mitral valve surgery. This article aimed to analyze the clinical data and prognostic outcomes of patients with diverse left atrium diameter (LAD) (>50 or ≤50 mm) who underwent total thoracoscopic mitral valve surgery combined with AFRA. We conducted a prospective analysis of patients who underwent AFRA from January 2021 to June 2022 in the Department of Cardiovascular Surgery at the Chinese PLA General Hospital. The inclusion criteria were: (I) aged 40-70 years; (II) diagnosed with valvular heart disease and concomitant long-term persistent AF (>1 year); (III) patients who underwent total thoracoscopic mitral valve surgery; (IV) with a left ventricular end-diastolic diameter of ≤70 mm; (V) with a LAD ≤65 mm; and (VI) left ventricular ejection fraction (LVEF) ≥50%. The included patients were assigned to group A and B depend up on the LAD. All patients were followed up at 3 and 6 months timepoints postoperatively. The prime endpoint was the recovery rate of sinus rhythm. There were 24 cases in group A (LAD >50 mm) and 16 cases in group B (LAD ≤50 mm). The two groups exhibited no statistical differences in terms of age, gender proportion, preoperative comorbidities, AF duration, preoperative heart function, and type of valve disease (P>0.05). The LAD, pulmonary artery pressure, and left ventricular diameter of group A were significantly greater than those of group B (P<0.05). There were no new cerebrovascular incidents during the perioperative and follow-up periods. The sinus rhythm conversion rates in group A after surgery and at 6 months were 75% and 66.7%, respectively; meanwhile, both of these values were 87.5% in group B, and the difference between the groups was statistically significant (P<0.05). Total thoracoscopic mitral valve surgery with AFRA is more effective in maintaining sinus rhythm in patients with LAD ≤50 mm than in those with LAD >50 mm without increased risk of adverse events. Further studies are warranted to validate our findings.

Is Elective Implant Removal after Fracture Healing Beneficial? - A Prospective Cohort Study.

Elective implant removal following healed extremity fractures remains controversial. This study aimed to evaluate the reasons and outcomes of implant removal after uneventful healing of limb fractures. This is a prospective single-centre observational cohort study. Patients who sustained upper or lower extremity fractures that were fixed and healed uneventfully were included in the study when they elected to remove the implants. Patients were followed for six months post-operatively. Outcomes were assessed with patient satisfaction, symptoms resolution, and complications. A total of 43 patients were recruited from October 2016 to March 2019. Thirty-six patients (37 implants) were symptomatic. Pain and prominence were the most common complaints, present in 59.5% and 33.3% of patients, respectively. Cold weather pain was also not uncommon (19.0%). Pain improved in 91.3% of the patients who complained of pain. The 94.6% symptomatic patients had at least partial resolution of pre-operative symptoms. All the patients who completed follow-up were satisfied with the procedure. In two patients, there were broken and retained screws intra-operatively. Post-operative complication rate was 23.8%, although no major complications occurred. Implant removal after uneventful healing of extremity fractures is a safe procedure that conferred a predictable relief of symptoms and satisfactory outcomes in most.

Association of coagulation markers and antiphospholipid antibodies with ischemic and bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention

Abstract Background Antiphospholipid antibodies and other coagulation markers are associated with ischemic risk in patients with coronary artery disease without oral anticoagulation (OAC). Aim To assess the association of antiphospholipid antibodies (aPL) and conventional markers of coagulation with ischemic and bleeding risk in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). Patients and methods In this prospective single center observational cohort study, patients with AF and an indication for OAC were enrolled after PCI. Dilute Russell's viper venom time (DRVVT) was used to determine lupus anticoagulants (LA) in direct OAC-free plasma. Anti-cardiolipin IgG (aCL), IgM and anti-beta2GP-1-IgG (aβ2GP1) were analyzed by enzyme linked immunosorbent assay (ELISA). Fibrinogen C (FIBC), d-dimers and prothrombin fragments 1 and 2 (PF1+2) were measured in citrated plasma. Immature platelet fraction (IPF [%]) and absolute (IPF abs. [103/μl]) were measured in EDTA-blood. The primary ischemic outcome was defined as time to major adverse cardiovascular events (MACE: all-cause death, myocardial infarction, or stroke) assessed at 6 months. Bleeding was defined according to the International Society of Thrombosis and Haemostasis (ISTH) and the Bleeding Academic Research Consortium (BARC). Results 158 patients were enrolled between May 2020 and May 2021. The median age was 78 years (interquartile range, IQR 72–82), 111 (70%) were male, and 39 (25%) presented with acute coronary syndrome. All Patients were treated with clopidogrel and OAC, 145 (92%) in addition with acetylsalicylic acid (ASA). 32 patients (20%) had ≥1 antiphospholipid antibody (aPL; LA: 19 [12%], aCL: 14 [9%], aβ2GP1: 2 [1%]). D-dimers were elevated in 74 patients (47%), FIBC was increased in 40 (25%) and PF1+2 in 68 patients (43%). IPF [%] was elevated in 28 (18%) and IPF abs. [103/μl] in 11 (7%). The presence of aPL was neither significantly associated with MACE, nor with bleeding risk. Elevated d-dimers were significantly associated with higher risk for MACE (HR=5.1, 95% CI [1.1; 23.4], p=0.04), major ISTH bleeding events (HR= 6.9, 95% CI [1.5; 30.8], p=0.01) and BARC bleeding type 3 or 5 (HR=6.4, 95% CI [1.4; 28.7], p=0.02). Increased levels of FIBC were associated with risk of MACE (HR= 3.6, 95% CI [1.1; 12.0], p=0.03 (Table 1). Conclusion In patients with AF undergoing PCI, high levels of d-dimers and fibrinogen C indicate an increased ischemic risk. Elevated d-dimers are associated with higher risk for bleeding. aPL positivity was not significantly associated with outcome possibly due to low sample size. A combined panel of biomarkers might be suitable to assess ischemic and bleeding risk in patients with AF following PCI. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Faculty of Medicine, Freiburg

Acid fast bacillus smear, mycobacterial culture and Xpert MTB/RIF assay for the diagnosis of tuberculous peritonitis in patients with and without end stage renal failure.

Introduction. Diagnosis of tuberculous peritonitis (TBP) requires a high index of suspicion.Hypothesis /gap statement. Information about the diagnostic features of TBP among patients with end-stage renal failure (ESRF) from India is limited.Aim. To assess the utility of the Gene Xpert MTB/RIF assay in the diagnosis of TBP in patients with end-stage renal failure (ESRF), compared with those without ESRF.Methodology. This prospective observational single centre cohort study was performed at a tertiary care centre in Northern India. Ascitic fluid and/or whole continuous ambulatory peritoneal dialysis (CAPD) bag with effluent from 300 clinically suspected cases of TBP were included in the study. Diagnosis was based on detection of Mycobacteria on smear, Xpert MTB/RIF assay and/or culture. Cell counting was done in a Neubauer chamber. Cell predominance was seen by Giemsa stain. Line probe assay (LPA) for drug susceptibility testing was performed on all positive cultures.Results. TBP was diagnosed in 168 cases. Diabetes mellitus was a significant risk factor for developing TBP in patients with ESRF (P value<0.01). Lymphocytic predominance was seen in 21 patients without ESRF (P value 0.033) while majority of the patients in both groups had neutrophils in their ascitic and peritoneal fluids (138/168; P value 0.033). We recovered 15 cases of laboratory diagnosed TBP (11 without ESRF and four with ESRF). Microscopy was positive in two cases while ten isolates were recovered on culture. The Xpert MTB/RIF assay was positive in seven ascitic fluid samples out of which three were rifampicin resistant. All these were patients without renal failure (P value 0.010). Eight culture positive samples tested by the line probe assay did not detect any resistance to either rifampicin or isoniazid.Conclusion. The GeneXpert MTB/RIF assay has a limited value in the diagnosis of TBP in patients with ESRF.

Associations between pre-stroke physical activity and physical quality of life three months after stroke in patients with mild disability.

Much is known about the association between physical activity and the occurrence of stroke. However, the evidence about the correlation between pre-stroke physical activity and post-stroke quality of life remains inconsistent. Thus, there is a high public health relevance to the topic. The aim of this study was to investigate the association between pre-stroke physical activity and physical quality of life after three months. Data arises from 858 patients with stroke included a prospective single-centre observational cohort study in Augsburg, Germany, between September 2018 and November 2019. The participants were recruited at the Department of Neurology and Clinical Neurophysiology, University Hospital of Augsburg after their stroke event. The level of physical activity was determined following the short form of the International Physical Activity Questionnaire at baseline. Physical quality of life was assessed three months after hospital discharge using the German version of the Stroke Impact Scale (SIS). A multiple linear regression model and a quantile regression were carried out. A total of 497 patients were included in the analysis (mean age 69.6, 58.8% male), 26.2% had a high, 18.9% a moderate and 54.9% a low level of pre-stroke physical activity. Patients with high pre-stroke physical activity had a significantly better physical quality of life three months after stroke in the SIS physical domain (beta = 4.1) and in the SIS subdomains hand function (beta = 5.6), mobility (beta = 4.1) and activities of daily living (beta = 3.7). In the physical domain and the subdomain mobility, the effect was especially strong for persons with low physical quality of life after three months. Pre-stroke physical activity seems to have an important and positive association with physical quality of life after three months in patients with mild disability. Further studies are needed to confirm these results.

Prognostic value of intrathecal IgM synthesis determined by various laboratory methods in patients with early multiple sclerosis - a prospective observational study

BackgroundIntrathecal IgM synthesis has been identified as an adverse prognostic factor in patients with multiple sclerosis (MS); however, some studies have not confirmed this association. The objective of this study was to evaluate the clinical utility of intrathecal IgM synthesis for prediction of disease activity and disability in patients after the first demyelinating event of MS. MethodsWe conducted a single-centre prospective observational cohort study at the Department of Neurology, University Hospital Ostrava, Czech Republic. Intrathecal IgM synthesis was demonstrated by the presence of cerebrospinal fluid-restricted oligoclonal IgM bands and calculated using the Reiber, Auer, and Öhman formula and IgM index. ResultsA total of 61 patients with a clinically isolated syndrome or early relapsing-remitting MS were enrolled into the analysis of which 37 (61 %) were women. The median age at the disease onset was 32 years (interquartile range [IQR] 25 – 42), and the median disease duration was 2.8 years (IQR 2.4 – 3.5). Thirty-eight (62 %) patients experienced a second relapse of MS with a median of 312 days (IQR 192 – 424), and 29 (47.5 %) developed magnetic resonance imaging (MRI) activity during the follow-up. Intrathecal IgM synthesis did not affect the risk of a second relapse or evidence of MRI activity in univariate and multivariate Cox regression analysis. There was no significant difference in disability using the Expanded Disability Status Scale and progression index in patients with or without intrathecal IgM synthesis. ConclusionThis prospective cohort study did not demonstrate that intrathecal IgM synthesis is a risk factor for a second relapse or MRI activity. It was not associated with higher disability in patients after the first demyelinating event.

Cohort profile: ‘Biomarkers of Personalised Medicine’ (BioPersMed): a single-centre prospective observational cohort study in Graz/Austria to evaluate novel biomarkers in cardiovascular and metabolic diseases

PurposeAccumulating evidence points towards a close relationship between cardiovascular, endocrine and metabolic diseases. The BioPersMed Study (Biomarkers of Personalised Medicine) is a single-centre prospective observational cohort study with repetitive examination...