Multicenter Prospective Cohort Study Research Articles

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.

Efficacy of Danlou tablets in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a multicenter prospective cohort study.

Danlou tablets (DLTs) have been widely used to treat coronary heart disease in China. However, the benefits associated with DLT for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in routine practice require further investigation. To investigate the effectiveness of DLT in patients with ACS undergoing PCI. This multicenter prospective cohort study for patients with ACS undergoing PCI was conducted in 40 centers in mainland China from February 2012 to December 2018. This trial is registered under ChiCTR-OOC-14005552. Patients were assigned to either the DLT group or the conventional medicine (CM) group based on whether they used DLT prior to enrollment. The duration of DLT use (1.5 g, three times a day) was 12 months. The primary endpoint comprised of cardiac death, non-fatal myocardial infarction, and urgent revascularization. Secondary endpoint included rehospitalization owing to ACS, heart failure, stroke, and other thrombotic events. The Seattle Angina Questionnaire (SAQ) was used to assess quality of life (QOL). Primary and secondary endpoints were followed up for 36 months, and the SAQ was followed up for 12 months. The Cox proportional hazards regression model was used to analyze the independent effect of DLT on primary and secondary endpoints. Propensity score matching (PSM) analyses were performed to mitigate bias. Survival estimation was performed using Kaplan-Meier survival curves and log-rank tests in the PSM cohort, and landmark analyses were used for further evaluation of primary and secondary endpoints. Subgroup analyses and interactions confirmed the robustness of the findings. Linear mixed effects models were used to assess the QOL. Overall, 936 patients were enrolled in this cohort study, of whom 875 completed follow-up. The primary and secondary endpoints had no significantly difference between the DLT and CM groups after Cox proportional hazards models. Kaplan-Meier survival curves and log-rank tests performed in the PSM cohort also found no significant differences between the two groups on primary and secondary endpoints. However, landmark analysis showed significant benefit in the primary endpoint for the DLT group after 200 days (hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.22-0.93, P = 0.03). Landmark analysis also showed a significant benefit in the secondary endpoint in the DLT group within 200 days (HR 0.33, 95% CI 0.15-0.73, P = 0.006). Moreover, DLT improves the SAQ summary score, and scores in the physical limitation, treatment satisfaction, and disease perception domains for patients with ACS undergoing PCI. DLT combined with conventional treatment reduced the risk of the primary endpoint after 200 days and the secondary endpoint within 200 days during the 3-year follow-up. Additionally, DLT can improve the QOL without adverse effects.

Gastrointestinal function and pain outcomes following segmental resection or discoid resection for low rectal endometriosis.

This study aims to examine the effect of full thickness discoid resection (FTDR) and modified, limited nerve-vessel sparing segmental bowel resection (NVSSR) in symptomatic patients with low rectal deep endometriosis (DE) within 7 cm from the anal verge. Presurgical and postsurgical evaluation of gastrointestinal (GI) function reflected by low anterior resection syndrome (LARS) and gastrointestinal function-related quality of life index (GIQLI) scores, complication rates, pain scores/visual analog scale (VAS) and endometriosis health profile (EHP-30) was performed. In this prospective multicenter cohort study, 63premenopausal patients with symptomatic low (within 7 cm from the anal verge) colorectal endometriosis, undergoing low modified limited nerve vessel sparing rectal segmental bowel resection (NVSSR) and full thickness discoid resection (FTDR) were evaluated. Presurgery and postsurgery lower anterior resection syndrome (LARS) scores, gastrointestinal function-related quality of life index (GIQLI), pain symptoms, endometriosis health profile (EHP-30) parameters compared between two groups. Out of 63women, 49(77.8%) underwent NVSSR while 14(22.2%) underwent FTDR. LARS-like symptoms were observed presurgically in 24/63 (38.1%) patients. Postsurgical LARS was observed in 14/63 (22.2%) of the patients (10/49, 20.4% in NVSSR vs.4/14, 28.5% in the FTDR group). The LARS-like symptoms significantly decreased following surgery in the FTDR group (p = 0.049) and showed atrend for decrease in the NVSSR group (p = 0.077). Postsurgical de novo LARS was only observed in 5/63 (8%) of the patients (NVSSR 4/49, 8.1%, FTDR 1/14, 7.1%). Postsurgical GIQLI scores improved in both groups (p < 0.001) with comparable changes in the NVSSR and FTDR cohorts (p = 0.490). Postoperative gradeIII complication rates between NVSSR and FTDR did not vary significantly (6/49, 12.2% vs.3/14, 21.4% p = 0.26). Pain/VAS scores and EHP-30 scores significantly decreased after amean follow-up of 29.6 ± 11 months and 30.6 ± 11months in the NVSSR and FTDR groups, respectively (EHP-30; p < 0.001; dysmenorrhea, dyspareunia, dyschezia all p < 0.05 for both cohorts). When comparing low colorectal surgery by either NVSSR or FTDR in ahigh-risk group for surgical complications, both techniques confer improvement of GI function reflected by LARS and GIQLI with non-significant differences in major complication rates, reduced pain and EHP-30 scores.

Prospective evaluation of cystatin C in the assessment of kidney dysfunction and survival in liver transplant candidates.

Kidney dysfunction is associated with decreased survival in liver transplant (LT) candidates, yet serum creatinine (sCr) is a poor surrogate for glomerular filtration rate (GFR) in this population. Serum cystatin C (CysC) may provide a more accurate assessment of kidney function and predict outcomes. We performed a multicenter prospective cohort study of consecutive candidates for LT. CysC was obtained at LT evaluation (n = 244), and a subset underwent simultaneous I 125 -iothalamate clearance for measured GFR (mGFR) assessment (n = 137). Patients were followed to assess the need for pre-LT renal replacement therapy, simultaneous liver and kidney transplant, and survival. Estimated GFR (eGFR) based on MDRD-4, GRAIL, Royal Free Hospital Cirrhosis GFR, and the CKD-EPI equations was assessed for bias, precision, and accuracy in reference to mGFR. Receiver operator characteristic (AUROC) and competing risk survival analyses were performed. CysC more accurately discriminated mGFR than sCr at thresholds of ≤60 and ≤30mL/min/1.73m 2 with AUROC 0.92 ( p = 0.005) and 0.96 ( p =0.01), respectively. All eGFR equations overestimated GFR, especially among females ( p < 0.05). The GRAIL equation demonstrated the least bias, while CKD-EPI-cystatin C was associated with the greatest precision and lowest frequency of GFR overestimation. Among 165 recipients of LT, CysC discriminated pre-LT renal replacement therapy and the need for simultaneous liver and kidney transplant with AUROC of 0.70 and 0.85, respectively. Cumulative incidence of death, accounting for LT as a competing event, increased with CysC ( p = 0.002) but was not observed with sCr overall or among subgroups ( p = NS). CysC more accurately predicts thresholds of mGFR than sCr in candidates for LT. Elevated CysC discriminates pre-LT renal replacement therapy and simultaneous liver and kidney transplant and is strongly associated with survival in contrast with sCr. CysC is a promising tool to improve prognostication among candidates for LT.

Development of predictive model for post-stroke depression at discharge based on decision tree algorithm: A multi-center hospital-based cohort study

ObjectivePost-stroke depression (PSD) is one of the most common and severe neuropsychological sequelae after stroke. Using a prediction model composed of multiple predictors may be more beneficial than verifying the predictive performance of any single predictor. The primary objective of this study was to construct practical prediction tools for PSD at discharge utilizing a decision tree (DT) algorithm. MethodsA multi-center prospective cohort study was conducted from May 2018 to October 2019 and stroke patients within seven days of onset were consecutively recruited. The independent predictors of PSD at discharge were identified through multivariate logistic regression with backward elimination. Classification and regression tree (CART) algorithm was employed as the DT model's splitting method. ResultsA total of 876 stroke patients who were discharged from the neurology departments of three large general Class A tertiary hospitals in Wuhan were eligible for analysis. Firstly, we divided these 876 patients into PSD and non-PSD groups, history of coronary heart disease (OR = 1.835; 95 % CI, 1.106–3.046; P = 0.019), length of hospital stay (OR = 1.040; 95 % CI, 1.013–1.069; P = 0.001), NIHSS score (OR = 1.124; 95 % CI, 1.052–1.201; P = 0.001), and Mini mental state examination (MMSE) score (OR = 0.935; 95 % CI, 0.893–0.978; P = 0.004) were significant predictors. The subgroup analysis results have shown that hemorrhagic stroke, history of hypertension and higher modified Rankin Scale score (mRS) score were associated with PSD at discharge in the young adult stroke patients. ConclusionsSeveral predictors of PSD at discharge were identified and convenient DT models were constructed to facilitate clinical decision-making.

2024 Kappa Delta Ann Doner Vaughan Award Nonsurgical Treatment of Symptomatic, Atraumatic Full-Thickness Rotator Cuff Tears-a Prospective Multicenter Cohort Study With 10-Year Follow-Up.

The Multicenter Orthopaedic Outcomes Network Shoulder Group conducted a prospective cohort study of 452 patients with symptomatic atraumatic rotator cuff tears treated with a physical therapy program to determine the predictors of failure of nonsurgical treatment, to provide insight into indications for surgery. After 10 years, we found the following: (1) Physical therapy was effective for over 70% of patients. (2) PROMs showed statistical and clinical improvement after 12 weeks of therapy and did not decline over 10 years. (3) Cuff tear severity did not correlate with pain, duration of symptoms, or activity level. (4) Of those who had surgery, 56.7% had surgery in the first 6 months while 43.3% had surgery between 6 months and 10 years. (5) Early surgery was primarily driven by low patient expectations regarding the effectiveness of therapy. (6) Later surgery predictors included workers' compensation status, activity level, and patient expectations. (7) Only 1 patient had a reverse arthroplasty (0.2% of the cohort). These data suggest that physical therapy is an effective and durable treatment of atraumatic symptomatic rotator cuff tears and most patients successfully treated with physical therapy do not exhibit a decline in patient-reported outcomes over time. Reverse arthroplasty after nonsurgical treatment is exceptionally rare.

COVID-19 and Female Fertility: An Observational Prospective Multicenter Cohort Study: Upholding Reproductive Rights in Emergency Circumstances.

Currently available research data points to COVID-19-related multi-organ system damage. This study aims to evaluate the impact of SARS-CoV-2 on the reproductive health, that is, plasma levels of FSH, LH, estradiol, AMH, and antral follicular count, of women undergoing level II ART techniques. This is a multicenter, prospective, and observational study by the reproductive medicine centers of Palermo's Ospedali Riuniti Villa Sofia-Cervello Hospital and Vanvitelli University. From September 2022 to March 2024, 203 patients aged 24-43 were enrolled, all with diagnosed infertility and a history of SARS-CoV-2 infection. Symptomatic women, patients testing positive for HIV or other liver viruses, and patients with a history of ovarian cancer or who had taken gonadotoxic drugs were excluded. Plasma measurements of FSH, LH, estradiol, AMH, and antral follicular count were performed before and after infection. The analysis accounting for the concentration of anti-Müllerian hormone (AMH) before and after COVID-19 infection shows an average concentration decrease from 1.33 ng/mL before SARS-CoV-2 infection to 0.97 ng/mL after infection. Average decrease after infection was -27.4%; average reduction of 1 follicle (95% CI: from -0.74 to -1.33) was reported following SARS-CoV-2 infection. Levels of E2 before and after SARS-CoV-2 infection did not vary significantly. Average FSH and LH levels before and after SARS-CoV-2 infection pointed to an increase. SARS-CoV-2 infection damages female reproductive health, causing significant reductions in AMH (-27.4%) and AFC (-1 antral follicle) values and an increase in FSH (+13.6%) and LH (+13.4%) values. No effect on E2 levels was reported. The pandemic has also affected the ability of infertile patients to access ART procedures, and that calls for a novel, updated blueprint designed to enhance our preparedness in the event that similar circumstances should occur again.

Poor nutrition status associated with low patient satisfaction six months into treatment for head and neck/esophageal cancer treatment: A prospective multicenter cohort study

AbstractBackgroundPatient‐reported outcome measures have been associated with survival in oncology patients. Altered intake and malnutrition are common symptoms for patients treated for head and neck cancer and esophageal cancer (HNC/EC). The purpose of this study was to examine the relationship between patient‐reported satisfaction with medical care and nutrition status.MethodsThis prospective cohort study collected data from 11 international cancer care sites.ResultsOne hundred and sixtythree adult patients (n = 115 HNC; n = 48 EC) completed a patient satisfaction questionnaire (the Canadian Health Care Evaluation Project Lite) and were included. HNC/EC patient global satisfaction with medical care was 88.3/100 ± 15.3 at baseline and remained high at 86.6/100 ± 16.8 by 6 months (100 max satisfaction score). Poor nutrition status, as defined by the Patient‐Generated Subjective Global Assessment Short Form, was associated with lower patient satisfaction with overall medical care, relationship with doctors, illness management, communication, and decision‐making 6 months into treatment (P &lt; 0.01). There was no difference in global satisfaction between patients who did and did not report swallowing difficulty (P = 0.99) and patients with and without feeding tube placement (P = 0.36). Patients who were seen by a dietitian for at least one nutrition assessment had global satisfaction with care that was 16.7 percentage points higher than those with no nutrition assessment (89.3 ± 13.8 vs 72.6 ± 23.6; P = 0.005)ConclusionIn HNC/EC patient‐centered oncology care, decreasing malnutrition risk and providing access to dietitian‐led nutrition assessments should be prioritized and supported to improve patient satisfaction and standard of care. Feeding tube placement did not decrease patient satisfaction with medical care.

MORe PREcISE: Longitudinal patient reported outcome measures in stroke at 3 and 6 months.

Background and PurposePost-stroke morbidity is common, but little is known about the burden on patients’ lives from their own perspective. Understanding morbidity from the point of view of the patient may support targeted intervention in post-stroke recovery. This study used a stroke specific Patient Reported Outcome Measure (PROM) containing Mental health (MH) and Physical Health (PH) domains and 5 stroke specific questions. We aimed to consider trends over a 6-month period and further assess the association between the MH and PH measures and common clinical measures. MethodsA multicenter prospective cohort study was conducted at 19 hospital sites across England and Wales. Patients were enrolled from August 2018 to September 2019. Clinical measures and PROMs were assessed at three timepoints: acutely following the index stroke, at 3 and 6-months post-stroke. Clinical measures and PROMs were assessed in each of these points. ResultsPhysical health PROM domains show significant gradual improvement across the study period (χ2 42.6312, p<0.0001), whereas cognitive function domains (χ2 3.7849, p<0.875) did not echo this trend. All clinical measures (GAD-7, PHQ9, MoCA, MRS) were associated with poorer PROM MH outcomes, (aMD -4.4, CI -0.59, -0.29, p≤0.001, aMD -0.45, CI -0.59, -0.32, p=<0.001, aMD 0.75, CI 0.56, 0.95, aMD -1.91, CI -2.41, -1.47, p≤0.001). Clinical measures of disability, as per the MRS, are associated with poor PROM PH scores (aMD -0.57, 95% CI -0.94, -0.20, p=0.003). ConclusionsThis research indicates there is unmet cognitive burden in stroke survivors. PROMs may be able to measure unmet more discretely than common clinical tools that are used post-stroke. Further research and guidance on how to integrate PROMs into current clinical frameworks is essential.

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.

Red Blood Cell Transfusion for Incidence of Retinopathy of Prematurity: Prospective Multicenter Cohort Study.

Retinopathy of prematurity (ROP) is a leading cause of visual impairment and blindness in preterm infants. This study sought to investigate the association between red blood cell (RBC) transfusion and ROP in very preterm infants (VPIs) to inform clinical strategies for ROP prevention and treatment. We designed a prospective multicenter cohort study that included VPIs and follow-up data from January 2017 to December 2022 at 3 neonatal clinical medicine centers. They were categorized into a transfusion group (infants who received an RBC transfusion within 4 wk) and a nontransfusion group. The relationship between RBC transfusion and ROP incidence was assessed using binary logistic regression, with subgroup analyses based on gestational age, birth weight, sex, and sepsis status. Inverse probability of treatment weighting and propensity score matching were applied to account for all potential confounding factors that could affect ROP development, followed by sensitivity analysis. The study included 832 VPIs, including 327 in the nontransfusion group and 505 in the transfusion group. The transfusion group had a lower average birth weight and gestational age and a greater incidence of ROP, ≥stage 2 ROP, and severe ROP. Logistic regression analysis revealed that the transfusion group had a significantly greater risk of ROP (adjusted odds ratio [aOR] 1.70, 95% CI 1.14-2.53, P=.009) and ≥stage 2 ROP (aOR 1.68, 95% CI 1.02-2.78, P=.04) but not severe ROP (aOR 1.75, 95% CI 0.61-5.02, P=.30). The trend analysis also revealed an increased risk of ROP with an increasing number of transfusions and a larger volume of blood transfused (P for trend<.001). Subgroup analyses confirmed a consistent trend, with the transfusion group at a higher risk for ROP across all subgroups. Inverse probability of treatment weighting and propensity score matching analyses supported the initial findings. For VPIs, RBC transfusion significantly increases the risk of ROP, and the risk increases with an increasing number of transfusions and volume of blood transfused.

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.

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).

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.