Clinical Performance Research Articles

Academic performance of students in an accelerated medical pathway

ABSTRACT Accelerated medical school curricula, such as three-year programs, have gained attention in recent years but studies evaluating their impact are still scarce. This study examines the Fully Integrated Readiness for Service Training (FIRST) program, a three-year accelerated pathway, to assess its impact on students’ academic performance preparedness for residency. In this observational study, we compared the academic outcomes of FIRST program students to traditional four-year curriculum students from 2018 to 2023. We analyzed multiple metrics, including exam performance (United States Medical Licensing Examination Step scores, shelf exam scores, and pre-clinical course scores) and clinical performance scores during the application and individualization phases. Analysis of Variance was used to examine the effect of accelerated pathway program experience relative to traditional 4-year medical school curriculum on the learning outcomes. FIRST program students were on average 1.5 years younger upon graduation than their traditional peers. While FIRST program students scored slightly lower on Step 2 Clinical Knowledge (CK), they exhibited no significant differences in other exam scores or clinical performance relative to the traditional students. Notably, FIRST students achieved equivalent clinical performance ratings during critical clerkships and rotations. Our findings suggest that a three-year medical school curriculum can effectively prepare students for residency and produce graduates with comparable medical knowledge and clinical skills, offering potential benefits in terms of financial relief and personal well-being for medical students.

Clinical effect of anlotinib in combination with docetaxel in treating advanced non-small cell lung cancer.

This study aimed to explore the clinical performance of anlotinib in combination with docetaxel in treating advanced non-small cell lung cancer (NSCLC). One hundred advanced NSCLC patients admitted to our hospital from January 2019 to December 2022 were retrospectively chosen to be the study objects, and separated into observation group (OG, n=50) and control group (CG, n=50) based on the different drugs used. The CG was given docetaxel injection. The OG was treated with anlotinib hydrochloride capsule combined with docetaxel injection. The clinical effective rate, levels of serum tumor markers, quality of life and occurrence of adverse reactions in both groups were compared. The total clinical effective rate in the OG presented elevated relative to the CG (P<0.01). After treatment, CEA, CA125, SCC and CYFRA21-1 levels in both groups were decreased in both groups, and those in the OG presented lower relative to the CG (P<0.05). After treatment, KPS score in both groups was increased in both groups and that in the OG presented higher relative to the CG (P<0.05). No difference was seen in the occurrence of adverse reactions between 2 groups (P=0.35). In treating advanced NSCLC patients, anlotinib combined with docetaxel can promote efficacy to a certain extent, effectively regulate the level of serum tumor markers, promote the quality of life of patients, and will not significantly affect clinical safety.

Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial.

To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices. Randomised controlled trial. St Mary's Hospital, Manchester, UK. Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively. Urine was self-collected and mixed with preservative - randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability. The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling. Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%-94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%-80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87-0.97, pMcN = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees. Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.

Clinical trial capacity building in a pandemic-outcome of a rapid site readiness project in Latin America.

Latin America (Latam) has a tradition of large-scale vaccine trials. Because of fluctuating demand, many sites have downsized their infrastructure. Therefore, BMGF launched a clinical trial site-readiness initiative early in the coronavirus-2019 (COVID-19) pandemic including Latam countries between August and September 2020. This survey evaluated clinical development performance measures pre/post initiative (September 2022). 20/21 prequalified sites participated in COVID-19 vaccine/drug development trials. 156 clinical trials (140 COVID-19 vaccine/drug trials) were initiated in the 2 years since prequalification, compared to 176 in the 5 years before. 33,428/37,810 participants were included in COVID-19 programs. The number of enrolled subjects/day across sites quadrupled from 15 (1-35) to 63 (5-300). The dropout rate was 6.8%. Study approval timelines were reduced from 60 (12-120) to 35 (5-90) days. Mean qualified staff was increased from 24 (6-80) to 88 (22-180). Clinical trial sites across Latam were successfully prequalified to participate in COVID-19 developments. For the 100 days mission of vaccine availability in a new pandemic sufficient and well-trained clinical trial sites readily available are essential. This is only achievable if sites-especially in low/middle-income countries-are maintained active through a constant flow of vaccine studies.

The endometrial cancer detection using non-invasive hypermethylation of CDO1 and CELF4 genes in women with postmenopausal bleeding in Northwest China

Objective: The objective of this study was to verify the clinical predictive performance of methylated cysteine dioxygenase type 1 (CDO1m) and CUGBP Elav-like family member 4 (CELF4m) in endometrial cancer (EC) women with postmenopausal bleeding (PMB). Material and Methods: A single-center, prospective, and case–control study was conducted in the Gansu Provincial Maternity and Child-care Hospital with 138 female postmenopausal patients enrolled in 2022. All patients underwent body mass index (BMI) detection, transvaginal ultrasonography (TVUS) detection, carbohydrate antigen 125 detection, and the cervical exfoliated cell CDO1/CELF4 gene methylation detection to analyze the sensitivity, specificity, and accuracy of different screening tests statistically with the biopsy and/or dilation and curettage (D&amp;C) pathological diagnosis under hysteroscopy as the gold standard. Results: There was no significant difference in age between the EC group and the non-EC group, P = 0.492. Using quantitative polymerase chain reaction (qPCR) technology, we validated the CDO1 and CELF4 methylation detection with 87.5% sensitivity and 95.9% specificity as a useful strategy for the triage of women with PMB for the detection of EC. In addition, 100% of type II EC (n = 6) were positively detected by the CDO1 or CELF4 methylation test. Conclusion: The CDO1 and CELF4 methylation test with high specificity as an auxiliary diagnostic tool or alternative method provides physicians with a reference to distinguish between benign and malignant tumors in women with postmenopausal bleeding, to justify the necessity of using invasive methods to confirm diagnosis.

Analytical and Clinical Performance of the NeuMoDx™ Platform for Cytomegalovirus and Epstein–Barr Virus Viral Load Testing

DNA assays for viral load (VL) monitoring are key tools in the management of immunocompromised patients with cytomegalovirus (CMV) or Epstein–Barr virus (EBV) infection. In this study, the analytical and clinical performances of the NeuMoDx™ CMV and EBV Quant Assays were compared with artus CMV and EBV QS-RGQ Kits in a primary hospital testing laboratory. Patient plasma samples previously tested using artus kits were randomly selected for testing by NeuMoDx assays. The NeuMoDx CMV Quant Assay and artus CMV QS-RGQ Kit limits of detection (LoDs) are 20.0 IU/mL and 69.7 IU/mL, respectively; 33/75 (44.0%) samples had CMV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.9503; 20 samples (60.6%) had lower NeuMoDx CMV quantification values versus the artus kit. The LoD of the NeuMoDx EBV Quant Assay and artus EBV QS-RGQ Kit are 200 IU/mL and 22.29 IU/mL, respectively; 16/75 (21.3%) samples had EBV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.8990. EBV quantification values with the NeuMoDx assay were higher versus the artus kit in 15 samples (93.8%). In conclusion, NeuMoDx CMV and EBV Quant Assays are sensitive and accurate tools for CMV and EBV DNA VL quantification.

Artificial Intelligence-Derived Risk Prediction: A Novel Risk Calculator Using Office and Ambulatory Blood Pressure.

Quantification of total cardiovascular risk is essential for individualizing hypertension treatment. This study aimed to develop and validate a novel, machine-learning-derived model to predict cardiovascular mortality risk using office blood pressure (OBP) and ambulatory blood pressure (ABP). The performance of the novel risk score was compared with existing risk scores, and the possibility of predicting ABP phenotypes utilizing clinical variables was assessed. Using data from 59 124 patients enrolled in the Spanish ABP Monitoring registry, machine-learning approaches (logistic regression, gradient-boosted decision trees, and deep neural networks) and stepwise forward feature selection were used. For the prediction of cardiovascular mortality, deep neural networks yielded the highest clinical performance. The novel mortality prediction models using OBP and ABP outperformed other risk scores. The area under the curve achieved by the novel approach, already when using OBP variables, was significantly higher when compared with the area under the curve of the Framingham risk score, Systemic Coronary Risk Estimation 2, and Atherosclerotic Cardiovascular Disease score. However, the prediction of cardiovascular mortality with ABP instead of OBP data significantly increased the area under the curve (0.870 versus 0.865; P=3.61×10-28), accuracy, and specificity, respectively. The prediction of ABP phenotypes (ie, white-coat, ambulatory, and masked hypertension) using clinical characteristics was limited. The receiver operating characteristic curves for cardiovascular mortality using ABP and OBP with deep neural network models outperformed all other risk metrics, indicating the potential for improving current risk scores by applying state-of-the-art machine learning approaches. The prediction of cardiovascular mortality using ABP data led to a significant increase in area under the curve and performance metrics.

Influence of ceramic crown design (translucent monolithic zirconia vs. bilayered) of implant-supported single crowns after mechanical cycling.

This study aimed to assess the influence of translucent monolithic versus bilayered crowns and whether the use of a CoCr base abutments affects the fatigue and fracture resistance of screwed implant-supported single crowns with external connections under mechanical cycling. Fifty specimens were divided into groups: (1) metal-ceramic (MC) crown, (2) veneered zirconia crown (Zr), (3) veneered zirconia crown with a CoCr base abutment (ZrB), (4) monolithic translucent zirconia crown (MZr), and (5) monolithic translucent zirconia crown with a CoCr base abutment (MZrB). Specimens underwent mechanical cycling (5 × 106 cycles; 150 N) evaluating fatigue resistance (number of failures) and those that failed were subsequently subjected to fractographic analyses (stereomicroscope and scanning electron microscope) to evaluate failure location and area, and maximum fracture load was also measured. The failure-related survival rate (100%) and maximum fracture resistance of the MZrB were significantly higher than those of MC and Zr (50%; p < 0.05). There were no significant differences in the failure rate and fracture resistance when a CoCr base abutment was used or not in the translucent monolithic Zr groups (p > 0.05;MZrB vs. MZr). Failure location, with MC crowns' fractures, noted at the screw area (p = 0.043), while all-ceramic crowns were mostly in the cuspid and to failure area, the Zr group had the largest mean (15.55 ± 9.17 mm2) among the groups, significant difference only when compared with MC (1.62 ± 0.81 mm2) (p = 0.025). Translucent monolithic zirconia crowns exhibited significantly higher fatigue and fracture resistance compared with conventional MC and bilayered crowns. The appropriate choice of material and manufacturing technique is crucial for predicting the higher clinical performance of single crowns. Enhanced mechanical resistance in terms of fatigue and fracture resistance can be achieved by replacing MC and bilayered restorations with computer-aided design and computer-aided manufacturing monolithic zirconia.

Feasibility of a quality-improvement program based on routinely collected health outcomes in Dutch primary care physical therapist practice: a mixed-methods study

BackgroundThis study evaluates the feasibility of a nine-month advanced quality-improvement program aimed at enhancing the quality of care provided by primary care physical therapists in the Netherlands. The evaluation is based on routinely collected health outcomes of patients with nonspecific low back pain, assessing three feasibility domains: (1) appropriateness, feasibility, and acceptability for quality-improvement purposes; (2) impact on clinical performance; and (3) impact on learning and behavioral change.MethodsA mixed-methods quality-improvement study using a concurrent triangulation design was conducted in primary care physical therapist practice. Feedback reports on the processes and outcomes of care, peer assessment, and self-assessment were used in a Plan-Do-Study-Act cycle based on self-selected goals. The program’s appropriateness, feasibility, and acceptability, as well as the impact on clinical performance, were evaluated using the Intervention Appropriate Measure, Feasibility Intervention Measure, Acceptability Intervention Measure (for these three measure, possible scores range from 4 to 20), and with a self-assessment of clinical performance (scored 0–10), respectively. The impact on learning and behavioral change was evaluated qualitatively with a directed content analysis.ResultsTen physical therapists from two practices participated in this study. They rated the program with a mean of 16.5 (SD 1.9) for appropriateness, 17.1 (SD 2.2) for feasibility, and 16.4 (SD 1.5) for acceptability. Participants gave their development in clinical performance a mean score of 6.7 (SD 1.8). Participants became aware of the potential value of using outcome data and gained insight into their own routines and motivations. They changed their data collection routines, implemented data in their routine practice, and explored the impact on their clinical behavior.ConclusionsThis explorative study demonstrated that a quality-improvement program, using health outcomes from a national registry, is judged to be feasible.Impact statementThis study provides preliminary evidence on how physical therapists may use health outcomes to improve their quality, which can be further used in initiatives to improve outcome-based care in primary physical therapy.

Clinical value of plasma ALZpath pTau217 immunoassay for assessing mild cognitive impairment

BackgroundAmong plasma biomarkers for Alzheimer’s disease (AD), pTau181 and pTau217 are the most promising. However, transition from research to routine clinical use will require confirmation of clinical performance in prospective...

Mapping simulation-based activities for health professionals in rural and remote contexts in high-income countries: a scoping review protocol.

This scoping review will aim to map the existing academic literature on simulation-based activities that are designed with and delivered for health professionals in geographically rural and remote contexts in high-income countries. Simulation-based health care activities are implemented in health services to increase patient safety because they allow health professionals to prepare, learn, practice, rehearse, and improve clinical performance and teamwork. Simulation-based activities are increasingly being used in rural and remote areas, where resources are limited compared with metropolitan areas. This review will include all primary and peer-reviewed research articles and abstracts that report health simulation methodologies and activities that have been used in rural and remote health care contexts in high-income countries. The proposed review will follow the JBI guidelines for scoping reviews and the PRISMA-ScR reporting guidelines. Databases to be searched will include Embase, Emcare, and MEDLINE (all searched via Ovid), Scopus, PubMed, and the Cochrane Database. The title and abstracts will be screened independently by 2 reviewers, followed by full-text screening. Data will be extracted and analyzed to address the review questions. https://doi.org/10.17605/OSF.IO/PU6GV.

[Chinese expert consensus on the analytical validation of tumor comprehensive genomic profiling next generation sequencing testing (2024 edition)].

In hospital laboratories-developed testing is of great significance for the clinical testing products that has not been approved by the National Medical Product Administration and is urgently needed to meet clinical practice needs. With the development of cancer precision medicine in recent years, comprehensive genomic profiling (CGP) has become an important means and method for the detection of drug targets, precise molecular typing, and immunotherapy biomarkers in cancer patients. However, there is still a lack of unified understanding and consensus on clinical testing standards and application specifications for laboratory-developed testing in the hospitals. The Molecular Pathology Collaboration Group of the Cancer Experts Committee of the Chinese Anti-Cancer Association and the Molecular Pathology Group of the Pathology Branch of the Chinese Medical Association initiated the expert consensus on relevant specifications for analytical validation of CGP next-generation sequencing (NGS) testing in Chinese hospitals. Combined with domestic clinical practice, refer to domestic and foreign literatures, from the background of the laboratory-developed testing, analytical validation scenarios, evaluation indicators and variation ranges, sample types and quantities covered by analytical validation, clinical performance and drug efficacy determination, and site personnel for analytical validation, quality control, inter-laboratory quality evaluation and document management, etc. After the discussion by the expert group, 12 expert consensuses were formed to provide reference for the analytical validation and clinical application of tumor CGP NGS testing in Chinese hospitals, so as to promote the laboratory-developed testing applications in Chinese hospitals.

Assessment of the Correlation and Diagnostic Accuracy between Cerebrospinal Fluid and Plasma Alzheimer's Disease Biomarkers: A Comparison of the Lumipulse and Simoa Platforms.

We compared the clinical and analytical performance of Alzheimer's disease (AD) plasma biomarkers measured using the single-molecule array (Simoa) and Lumipulse platforms. We quantified the plasma levels of amyloid beta 42 (Aβ42), Aβ40, phosphorylated tau (Ptau181), and total tau biomarkers in 81 patients with mild cognitive impairment (MCI), 30 with AD, and 16 with non-AD dementia. We found a strong correlation between the Simoa and Lumipulse methods. Concerning the clinical diagnosis, Simoa Ptau181/Aβ42 (AUC 0.739, 95% CI 0.592-0.887) and Lumipulse Aβ42 and Ptau181/Aβ42 (AUC 0.735, 95% CI 0.589-0.882 and AUC 0.733, 95% CI 0.567-0.900) had the highest discriminating power. However, their power was significantly lower than that of CSF Aβ42/Aβ40, as measured by Lumipulse (AUC 0.879, 95% CI 0.766-0.992). Simoa Ptau181 and Lumipulse Ptau181/Aβ42 were the markers most consistent with the CSF Aβ42/Aβ40 status (AUC 0.801, 95% CI 0.712-0.890 vs. AUC 0.870, 95% CI 0.806-0.934, respectively) at the ≥2.127 and ≥0.084 cut-offs, respectively. The performance of the Simoa and Lumipulse plasma AD assays is weaker than that of CSF AD biomarkers. At present, the analysed AD plasma biomarkers may be useful for screening to reduce the number of lumbar punctures in the clinical setting.

Effects of Standardized Patient Simulation and Mobile Applications on Nursing Students' Clinical Competence, Self-Efficacy, and Cultural Competence: A Quasi-Experimental Study.

Simulation-based education has emerged as an effective approach in nursing education worldwide. We aimed to evaluate the effectiveness of a surgical nursing education program based on a simulation using standardized patients and mobile applications among nursing students. A mixed-methods design with a quasi-experimental longitudinal approach and focus group interviews was employed. The data were collected from 130 third-year nursing students at three different time points who were equally divided into experimental and control groups. This study measured the level of clinical surgical nursing competence, self-efficacy in clinical performance, cultural competence, and satisfaction with simulation experience. Four focus group interviews were conducted using open-ended questions to explore the participants' perspectives on the course's efficacy and satisfaction. There were statistically significant differences in clinical surgical nursing competence (F = 8.68, p < 0.001), self-efficacy in clinical performance (F = 13.56, p < 0.001), and cultural competence (F = 10.35, p < 0.001) across time between the intervention and control groups. Student satisfaction with the simulation-based training was high, particularly regarding debriefing and reflection, with an overall mean satisfaction level of 4.25 (0.40). Students' perspectives regarding integrated hybrid training are categorized into three themes: educational achievement, dynamic learning experiences, and satisfaction and suggestion. Simulation-based learning provides a dynamic and immersive educational experience that enables undergraduate nursing students to develop and refine essential clinical skills while also fostering confidence and cultural competence.

Study protocol of a systematic review and metaanalysis of stress and burnout among general surgery residents

Introduction Chronic workplace stress and burnout are impediments to physicians’ professional fulfillment, healthcare organizations’ efficiency, and patient care quality/safety. General surgery residents are especially at risk due to the complexity of their training. We report the protocol of a metaanalysis of chronic stress and burnout among Accreditation Council for Graduate Medical Education (ACGME)–affiliated general surgery residents in the era after duty-hour reforms, plus downstream effects on their health and clinical performance. Methods The proposed systematic review and metaanalysis (PROSPERO registration CRD42021277626) will synthesize/pool data from studies of chronic stress and burnout among general surgery residents at ACGME-affiliated programs. The timeframe under review is subdivided into three intervals: (a) after the 2003 duty-hour restrictions but before 2011 reforms, (b) after the 2011 reforms but before the coronavirus pandemic, and (c) the first 3 years after the pandemic’s outbreak. Only studies reporting outcomes based on validated instruments will be included. Qualitative studies, commentaries/editorials, narrative reviews, and studies not published in English will be excluded. Multivariable analyses will adjust for sample characteristics and the methodological quality of included studies. Conclusions The metaanalysis will yield evidence reflecting experiences of North American-based general surgery residents in the years after ACGME-mandated duty-hour restructuring.

The Role of Verbal Fluency in the Cerebellar Cognitive Affective Syndrome Scale in Friedreich Ataxia.

Cerebellar pathology engenders the disturbance of movement that characterizes Friedreich ataxia (FRDA), yet the impact of cerebellar pathology on cognition in FRDA remains unclear. Numerous studies have unequivocally demonstrated the role of the cerebellar pathology in disturbed cognitive, language and affective regulation, referred to as Cerebellar Cognitive Affective Syndrome (CCAS), and quantified by the CCAS-Scale (CCAS-S). The presence of dysarthria in many individuals with ataxia, particularly FRDA, may confound results on some items of the CCAS-S resulting in false-positive scores. This study explored the relationship between performance on the CCAS-S and clinical metrics of disease severity in 57 adults with FRDA. In addition, this study explored the relationship between measures of intelligibility and naturalness of speech and scores on the CCAS-S in a subgroup of 39 individuals with FRDA. We demonstrated a significant relationship between clinical metrics and performance on the CCAS-S. In addition, we confirmed the items that returned the greatest rate of failure were based on Verbal Fluency Tasks, revealing a significant relationship between these items and measures of speech. Measures of speech explained over half of the variance in the CCAS-S score suggesting the role of dysarthria in the performance on the CCAS-S is not clear. Further work is required prior to adopting the CCAS-S as a cognitive screening tool for individuals with FRDA.

Sex Differences in Outcomes of Hepatobiliary and Pancreatic Surgery with Accelerated Rehabilitation.

Sex, in the sense of gender, is a major social demographic characteristic that has been shown to affect health care outcomes. The concept of enhanced recovery after surgery (ERAS) is an effective perioperative management measure that can reduce the perioperative stress response in patients. However, there are few studies on the differences between male and female patients under this type of care. We aimed to analyze sex differences in clinical characteristics among patients undergoing hepatobiliary and pancreatic surgery with accelerated rehabilitation. We enrolled patients who underwent liver, biliary tract, and gallbladder operations in the Department of Hepatobiliary and Pancreatic Surgery of Taizhou Hospital, Zhejiang Province, China, from April 2021 to July 2021. Key measures were collected for patients undergoing perioperative accelerated rehabilitation (i.e., the case group). The study group was assembled by performing 1:1 matching for age, sex, chronic disease, and type of surgery. Postoperative risk assessment, postoperative recovery indicators, and postoperative length of hospital stay (days) were compared between male and female patients. A total of 226 surgical patients were enrolled, including 109 male (48.23%) and 117 female patients (51.77%). The outcomes, presented as the median (min, max), were as follows: pulmonary rehabilitation risk assessment in females (1(0,3)) and males (0(0,2)), postoperative nausea and vomiting in females (2(1,3)) and males (1(0,2)), and time to first defecation in females (31(4,61)) and males (36(10,78)). Significant differences were indicated by p values < 0.05. We identified sex differences in the clinical prognosis and performance of perioperative patients undergoing hepatobiliary and pancreatic surgery with accelerated rehabilitation. The perioperative pulmonary rehabilitation risk of male patients was higher than that of female patients, and the time to first defecation was longer in male than in female patients. The incidence of nausea and vomiting in women was higher than in men.

The feedback dilemma in medical education: insights from medical residents’ perspectives

BackgroundFeedback is a critical component of the learning process in a clinical setting. This study aims to explore medical residents’ perspectives on feedback delivery and identify potential barriers to feedback-seeking in clinical training.MethodsThis cross-sectional study involved 180 medical residents across seventeen specialties. We employed the validated Residency Education Feedback Level Evaluation in Clinical Training (REFLECT) tool to assess residents’ perspectives on their attitude toward feedback, quality of feedback, perceived importance, and reaction to feedback. Additionally, we explored barriers to feedback-seeking behavior among medical residents.ResultsThe majority of medical residents held positive attitudes toward feedback. They agreed that feedback improves their clinical performance (77.7%), professional behavior (67.2%), and academic motivation (56.7%), while also influencing them to become a better specialist in their future career (72.8%). However, the study revealed critical deficiencies in the feedback process. Only 25.6% of residents reported receiving regular feedback and less than half reported that feedback was consistently delivered at suitable times and locations, was sufficiently clear or included actionable plans for improvement. A minority (32.2%) agreed that faculty had sufficient skills to deliver feedback effectively. Moreover, peer-to-peer feedback appeared to be a primary source of feedback among residents. Negative feedback, though necessary, often triggered feelings of stress, embarrassment, or humiliation. Notably, there were no significant differences in feedback perceptions among different specialties. The absence of a feedback-seeking culture emerged as a central barrier to feedback-seeking behavior in the clinical setting.ConclusionsEstablishing shared expectations and promoting a culture of feedback-seeking could bridge the gap between residents’ perceptions and faculty feedback delivery. Furthermore, recognizing the role of senior and peer residents as valuable feedback sources can contribute to more effective feedback processes in clinical training, ultimately benefiting resident development and patient care.

Utility of real-world evidence in biosimilar development

ABSTRACT Biosimilar development refers to the process of creating a biologic drug that is similar to an existing approved biologic drug, also known as a reference drug. Due to the complex nature of biologics drugs and the inherent variability in their manufacturing process biosimilars are not identical but highly similar to the reference drug in terms of quality, safety, and efficacy. Efficacy and safety trials for biosimilars involve large numbers of patients to confirm comparable clinical performance of the biosimilar and the reference product in appropriately sensitive clinical indications and for appropriate sensitive endpoints. The objective of a biosimilar clinical data is to address slight differences observed at previous steps and to confirm comparable clinical performance of the biosimilar and the reference product. In recent years with advances in big data computing, there has been increasing interest to incorporate the totality of information from different data sources (e.g. Real World data and published literature) in design and conduct of clinical trial to support regulatory objectives. The biosimilar development is an ideal framework for utilization of Real-World Evidence in design of trials as potentially large amount of data are available for the reference dug. Hence there may be an opportunity to use RWD in establishing, improving or validating equivalence margins (EQM) for biosimilar designs, specifically in the case there is no historical published data in the intended sensitive population. In this article, we propose a variation of matching method that seems promising to identify the matched set from a real-world data for which the effect size of targeted endpoint would be comparable to historical data. We believe this is a reasonable approach because in design stage, we can view covariates and secondary endpoints as data feature that can be used in a matching method. This approach was illustrated through a case study which indicated the estimate of the primary endpoint is within 1% of published results and thus RWD may be used to justify or estimate the equivalence margin. To ensure consistent results we recommend using this approach in different indications and endpoint scenarios. Thus utilization of RWD/RWE can provide an important opportunity to increase access to biologic therapies, reducing cost by repurposing existing data.

A Bicentric, International, Retrospective Study to Assess Steelex Sternum Set for Sternal Closure in Cardiac Surgery – STERCCAS a Cohort Study

Sternal fixation with steel wires or cerclages, is the gold standard for closing a midline sternotomy, the standard incision in cardiac surgery. Rare wound complications can occur following a sternotomy wire closure. The objective of this study is to establish that the clinical efficacy of the Steelex Sternum Set is equivalent to the results documented in existing literature. The cohorts of the previously conducted OPTICABG and PREMIVALVE studies served as a foundation for the design of this retrospective, bicentric, international, single-arm study. The purpose of the study was to evaluate the clinical performance of the Steelex Sternum Set for sternal closure after coronary artery bypass grafting or cardiac valve replacement/reconstruction surgery. The primary endpoint was the incidence of a composite consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection up to six months after surgery. A quantitative summary of the available clinical literature has been conducted for comparison purposes. There were 229 patients in total (89 PREMIVALVE and 140 OPTICABG). The combined rate of surgical site infection and sternal dehiscence/instability was 3.49%, compared to 1.5 - 20% described in the literature. Severe complications such as mortality, stroke, myocardial infarction, and mediastinitis occurred in about 0.8 - 2% of cases. The Steelex Sternum Set is a safe and appropriate method for sternal closure in a diverse patient population undergoing cardiac valve replacement and/or reconstruction, as well as coronary artery bypass graft surgery, in routine clinical settings.