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Medicine Jun 2024Complete dislodgement of a mechanical valve is extremely uncommon as a long-term issue after getting a substitute mitral valve, and this report details an incident of...
RATIONALE
Complete dislodgement of a mechanical valve is extremely uncommon as a long-term issue after getting a substitute mitral valve, and this report details an incident of complete detachment of a mechanical valve.
PATIENT CONCERNS
A 50-year-old woman, who underwent mitral mechanical valve replacement 2 decades earlier at another facility, was urgently admitted due to sudden cardiogenic shock.
DIAGNOSES
Transthoracic echocardiograms revealed severe malfunction of the mitral valve prosthesis, characterized by significant mitral regurgitation and moderate pulmonary hypertension. Following the insertion of extracorporeal membrane oxygenation and an intra-aortic balloon pump, the hemodynamics stabilized. Coronary angiography displayed the prosthetic mitral valve ring and leaflet floating in the left atrium, as confirmed by preoperative real-time 3-dimensional transesophageal echocardiography. A complete separation of the prosthetic ring and leaflet from the suture ring was observed.
INTERVENTIONS
The patient promptly underwent bioprosthetic mitral valve replacement.
OUTCOMES
The patient's postoperative course was uneventful, leading to discharge in good condition.
LESSONS
A crucial aspect is comprehending the structure of the prosthetic valve itself. The use of transthoracic echocardiography and real-time 3-dimensional transesophageal echocardiography provides additional structural and functional details, enhancing support for potential life-saving interventions. Echocardiography plays a significant role in evaluating the morphology and function of prosthetic valves.
Topics: Humans; Female; Middle Aged; Heart Valve Prosthesis; Mitral Valve Insufficiency; Prosthesis Failure; Mitral Valve; Heart Valve Prosthesis Implantation; Echocardiography, Transesophageal; Shock, Cardiogenic; Echocardiography, Three-Dimensional
PubMed: 38941392
DOI: 10.1097/MD.0000000000038612 -
Medicine Jun 2024Frailty has been identified as a risk factor for adverse outcomes in older adults with diabetes. This study aimed to investigate the impact of frailty on the prognosis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Frailty has been identified as a risk factor for adverse outcomes in older adults with diabetes. This study aimed to investigate the impact of frailty on the prognosis of older adults with diabetes through a systematic review and meta-analysis, with the goal of offering insights for clinical decision-making.
METHODS
PubMed, Web of Science, Embase, Cochrane were systematically searched from inception to September 10th, 2023. Reviewers independently selected studies, extracted data and evaluated the quality of studies. Stata 15.1 Software was used to perform the meta-analysis. The primary outcomes of this study were mortality, hospitalization and disability, and the secondary outcomes were diabetes complications (including nephropathy, microvascular complications, macroangiopathy, cardiovascular events, hypoglycemia) and urolithiasis.
RESULTS
A total of 14 studies were included in this study, with low risk of bias and moderate to good quality. The results showed that frailty increased the risk of mortality (HR 1.91, 95% CI 1.55-2.35, P < .001), hospitalization (HR 2.19, 95% CI 1.53-3.13, P < .001), and disability in older adults with diabetes (HR 3.84, 95% CI 2.35-6.28, P < .001). In addition, frailty was associated with diabetes complications (including nephropathy, microvascular complications, macroangiopathy, cardiovascular events, hypoglycemia), urolithiasis.
CONCLUSIONS
Frailty is an important predictor of adverse outcomes, such as mortality, hospitalization, and disability in older adults with diabetes. Accurate assessment of the frailty in older adults with diabetes can help improve the adverse outcomes of patients.
Topics: Humans; Aged; Frailty; Hospitalization; Diabetes Complications; Diabetes Mellitus; Risk Factors; Prognosis; Frail Elderly; Aged, 80 and over; Female; Male
PubMed: 38941383
DOI: 10.1097/MD.0000000000038621 -
JMIR Research Protocols Jun 2024Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have...
BACKGROUND
Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE
This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS
This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS
The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS
Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
TRIAL REGISTRATION
PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/51614.
Topics: Humans; Randomized Controlled Trials as Topic; Artificial Intelligence; Algorithms; Systematic Reviews as Topic; Patient Harm; Equipment and Supplies; Research Design
PubMed: 38941147
DOI: 10.2196/51614 -
JMIR Research Protocols Jun 2024Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases....
Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study.
BACKGROUND
Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases. Unfortunately, access to timely and appropriate rehabilitation remains limited. To help close this inaccessibility gap, telerehabilitation has been proposed. However, exercise testing is necessary for effective and safe exercise prescription. Current gold-standard tests, such as maximal cardiopulmonary exercise testing (CPET) and the 6-minute walk test (6MWT), are poorly adapted to home-based or telerehabilitation settings. This was an obstacle to the continuity of services during the COVID-19 pandemic. It is essential to validate tests adapted to these new realities, such as the 6-minute stepper test (6MST). This test, strongly inspired by 6MWT, consists of taking as many steps as possible on a "stepper" for 6 minutes.
OBJECTIVE
This study aims to evaluate the metrological qualities of 6MST by (1) establishing concurrent validity and agreement between the 6MST and CPET, as well as with the 6MWT; (2) determining test-retest reliability in a home-based setting with direct and remote (videoconferencing) monitoring; and (3) documenting adverse events and participant perspectives when performing the 6MST in home-based settings.
METHODS
Three centers (Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec in Québec, Groupement des Hôpitaux de l'Institut Catholique de Lille in France, and FormAction Santé in France) will be involved in this multinational project, which is divided into 2 studies. For study 1 (objective 1), 30 participants (Québec, n=15; France, n=15) will be recruited. Two laboratory visits will be performed to assess anthropometric data, pulmonary function, and the 3 exercise tolerance tests (CPET, 6MWT, and 6MST). Concurrent validity (paired sample t tests and Pearson correlations) and agreement (Bland-Altman plots with 95% agreement limits) will be evaluated. For study 2 (objectives 2 and 3), 52 participants (Québec, n=26; France, n=26) will be recruited. Following a familiarization trial (trial 1), the 6MST will be conducted on 2 separate occasions (trials 2 and 3), once under direct supervision and once under remote supervision, in a randomized order. Paired sample t test, Bland-Altman plots, and intraclass correlations will be used to compare trials 2 and 3. A semistructured interview will be conducted after the third trial to collect participants' perspectives.
RESULTS
Ethical approval was received for this project (October 12, 2023, in Québec and September 25, 2023, in France) and the first participant was recruited in February 2024.
CONCLUSIONS
This study innovates by validating a new clinical test necessary for the development and implementation of new models of rehabilitation adapted to home and telerehabilitation contexts. This study also aligns with the United Nations Sustainable Development Goals by contributing to augmenting health care service delivery (goal 3) and reducing health care access inequalities (goal 11).
TRIAL REGISTRATION
ClinicalTrials.gov NCT06447831; https://clinicaltrials.gov/study/NCT06447831.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/57404.
Topics: Humans; Chronic Disease; Exercise Test; Reproducibility of Results; COVID-19; Male; Female; Adult; Middle Aged; Telerehabilitation; Walk Test; Telemedicine
PubMed: 38941132
DOI: 10.2196/57404 -
Clinical and Experimental Medicine Jun 2024Both atezolizumab (a PD-L1 inhibitor) plus bevacizumab (A+B) and sintilimab (a PD-1 inhibitor) plus bevacizumab (S+B) are recommended as the first-line regimen for... (Comparative Study)
Comparative Study
Both atezolizumab (a PD-L1 inhibitor) plus bevacizumab (A+B) and sintilimab (a PD-1 inhibitor) plus bevacizumab (S+B) are recommended as the first-line regimen for advanced hepatocellular carcinoma (HCC) in China. Different efficacy between the two regimens combined with transvascular intervention for unresectable HCC (uHCC) remain unknown. We retrospectively analyzed uHCC patients treated in three centers by simultaneous combination of A+B or S+B with transarterial chemoembolization (TACE) and FOLFOX-based hepatic arterial infusion chemotherapy (HAIC). Objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and treatment-related adverse events (TRAEs) were compared. Totally 188 patients were included, with 92 and 96 administered A+B+TACE-HAIC (ABTH) and S+B+TACE-HAIC (SBTH), respectively. ORRs (62.0 vs. 70.8%, respectively; P = 0.257) and disease control rates (88.0 vs. 93.8%, P = 0.267) were similar between groups by the mRECIST criteria. ABTH showed no survival advantage over SBTH, with median PFS times of 11.7 months and 13.0 months, respectively (HR = 0.81, 95% CI, 0.52-1.26, P = 0.35) and similar OS times (HR = 1.19, 95% CI, 0.32-4.39, P = 0.8). No significant differences were observed in grade 3-4 TRAEs between groups. Either PD-L1 or PD-1 inhibitor plus bevacizumab combined with TACE-HAIC have similarly excellent therapeutic efficacy with manageable adverse events, representing promising treatment options for uHCC.
Topics: Humans; Carcinoma, Hepatocellular; Male; Bevacizumab; Middle Aged; Female; Liver Neoplasms; Retrospective Studies; Aged; Antineoplastic Combined Chemotherapy Protocols; Adult; Antibodies, Monoclonal, Humanized; Treatment Outcome; Immune Checkpoint Inhibitors; China; Chemoembolization, Therapeutic; Programmed Cell Death 1 Receptor; B7-H1 Antigen; Fluorouracil; Leucovorin
PubMed: 38940944
DOI: 10.1007/s10238-024-01415-y -
Alternative Therapies in Health and... Jun 2024The nursing work in the operating room is heavy, intensive, and irregular, and the quality of nursing work can directly affect the surgical effect and patient prognosis....
BACKGROUND
The nursing work in the operating room is heavy, intensive, and irregular, and the quality of nursing work can directly affect the surgical effect and patient prognosis. Therefore, nursing management in the operating room should be strengthened to protect patients' life safety effectively.
OBJECTIVE
To assess the effectiveness of applying the 6S management model in operating room nursing.
DESIGN
This was a retrospective study.
SETTING
This study was conducted at the Department of Anesthesia Surgery, Nanfang Hospital, Southern Medical University.
PARTICIPANTS
The research included 100 operating room nurses on duty between January 2020 and December 2022.
INTERVENTION
From January 2020 to June 2021, the hospital conducted routine training programs for nurses in the operating room. From July 2021 to December 2022, the hospital adopted the 6S management model for overseeing nursing work in the operating room.
PRIMARY OUTCOME MEASURES
(1) nursing quality score (2) nursing staff safety awareness (3) nursing disputes and complaints (4) incidence of adverse reactions (5) patient satisfaction with the quality of nursing care.
RESULTS
Following the adoption of the 6S management model, there was a noticeable improvement in the nursing quality scores, the nursing staff's awareness of safety, and the satisfaction levels of patients with the quality of care provided by operation nurses (P < .05). Additionally, the incidence of nursing disputes, complaints, and adverse events among patients decreased significantly compared to before the implementation of 6S (P = .01).
CONCLUSION
Implementing 6S management with a focus on the work of operation room nurses enhanced the competence of the nursing staff and improved management effectiveness, ultimately leading to increased patient satisfaction.
PubMed: 38940802
DOI: No ID Found -
Alternative Therapies in Health and... Jun 2024To analyze the effects of trimetazidine on ventricular remodeling and serum cystatin C (Cys C) and endothelin-1 (ET-1) levels in patients with chronic heart failure...
OBJECTIVE
To analyze the effects of trimetazidine on ventricular remodeling and serum cystatin C (Cys C) and endothelin-1 (ET-1) levels in patients with chronic heart failure (CHF).
METHODS
A total of 96 patients with CHF admitted to the fifth affiliated hospital of Xinjiang medical university. were enrolled as the research objects between June 2012 and June 2023. They were randomly divided into a control and observation groups, with 48 cases in each group. The control group was given routine treatment, while the observation group was additionally treated with trimetazidine hydrochloride tablets. All were continuously treated for 6 months. The clinical curative effect between the two groups was compared. The left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD) and left ventricular end-diastolic diameter (LVEDD) were measured by cardiac echocardiography before and after treatment. 6MVT before and after treatment was recorded. A full-automatic biochemical analyzer detected the level of serum Cys C before and after treatment. The levels of serum ET-1, galectin-3 (Gal-3), brain natriuretic peptide (BNP), and atrial natriuretic peptide (ANP) were detected by enzyme-linked immunosorbent assay before and after treatment. The incidence of adverse events in the two groups of CHF patients was compared.
RESULTS
The total response rate of treatment in the observation group was significantly higher than that in the control group (91.67% vs 79.17%) (P = .037). After treatment, LVEDD and LVESD decreased, while LVEF and 6MVT increased in both groups. LVEDD and LVESD in the observation group were significantly lower than those in the control group, while LVEF and 6MVT were significantly higher than those in the control group (P < .05). After treatment, serum Cys C, ET-1, Gal-3, BNP, and ANP levels in both groups were significantly decreased, significantly lower in the observation group than in the control group (P < .05). The readmission rate of the observation group was lower than that of the control group (P = .045). There was no significant difference in mortality between the two groups (P = .315).
CONCLUSION
Trimetazidine is effective in treating patients with CHF. It can improve cardiac function and reduce the rate of re-hospitalization.
PubMed: 38940778
DOI: No ID Found -
Alternative Therapies in Health and... Jun 2024To compare the operation-related indexes, complication rates, and cardiac function indexes of bioresorbable scaffolds with drug-eluting scaffolds in coronary non-left...
AIM
To compare the operation-related indexes, complication rates, and cardiac function indexes of bioresorbable scaffolds with drug-eluting scaffolds in coronary non-left main stem lesions and to clarify the clinical value of bioresorbable scaffolds in percutaneous coronary intervention for non-left main stem lesions.
METHODS
The retrospective study sample consisted of 60 non-left main stem lesions treated using bioresorbable stent or drug-eluting stents between June 2022 and June 2023. Comparison of surgical operation-related indexes, intraoperative and postoperative complications, cardiac function indexes, adverse cardiovascular events, and surgical success rate between the two groups.
RESULTS
The surgical operation time and X-ray exposure time of the experimental group were shorter than those of the control group, and contrast agent dosage was lower than that of the control group (P < .05). Left ventricular ejection fraction (LVEF) was higher than that in the control group at one month after surgery, and left ventricular end-systolic diameter (LVESD) and left ventricular end-diastolic diameter (LVEDD) in the experimental group was lower than that in the control group, and the difference was statistically significant (P < .05). The total incidence of major adverse cardiovascular events was lower in the experimental group than in the control group (15.6% VS. 71.4%)(P < .05).
CONCLUSION
Bioresorbable scaffolds are more effective than drug-eluting scaffolds in treating non-left main stem lesions by percutaneous coronary intervention. Furthermore, bioresorbable scaffolds could be considered a preferable option for certain patients undergoing percutaneous coronary intervention for non-left main stem lesions.
PubMed: 38940777
DOI: No ID Found -
Alternative Therapies in Health and... Jun 2024Congenital anal atresia poses a significant challenge in pediatric surgery, necessitating precise and effective interventions to ensure optimal outcomes. While...
BACKGROUND
Congenital anal atresia poses a significant challenge in pediatric surgery, necessitating precise and effective interventions to ensure optimal outcomes. While traditional anterior sagittal approach anoplasty has been a standard procedure, emerging evidence suggests potential benefits of anal dimple anorectoplasty.
OBJECTIVE
This study aims to assess the clinical efficacy of anal dimple anorectoplasty in treating congenital anal atresia.
METHODS
We conducted a rigorous systematic review and meta-analysis, extensively searching various databases such as Wanfang, CNKI, VIP, PubMed, Web of Science, and the Cochrane Library. Our aim was to identify randomized controlled trials comparing the efficacy of traditional anterior sagittal approach anoplasty with anal dimple anorectoplasty in treating congenital anal atresia. Search terms included "anal dimple anorectoplasty," "congenital anal atresia," and "RCT." Data regarding operation time, postoperative hospitalization duration, and complication rates were collected.
RESULTS
Anal dimple anorectoplasty exhibited significantly greater clinical efficacy (odds ratio [OR]=4.91, 95% confidence interval [CI]: 2.02-11.94, P < .00001), along with markedly reduced postoperative hospitalization duration (95% CI: -1.27 to -0.57, P < .00001), and a substantially lower incidence of complications (OR=0.1, 95% CI: 0.04-0.25, P < .00001) compared to traditional anterior sagittal approach anoplasty. These findings underscore the clear advantage of anal dimple anorectoplasty over conventional methods, indicating its potential as a preferred surgical approach for congenital anal atresia.
CONCLUSIONS
Anal dimple anorectoplasty emerges as a highly effective intervention for pediatric patients with congenital anal atresia, demonstrating a notable decrease in postoperative complications. These findings highlight its potential as a preferred surgical approach to enhance patient outcomes and minimize adverse events.
PubMed: 38940776
DOI: No ID Found -
Alternative Therapies in Health and... Jun 2024Neonatal pneumonia is a common respiratory disease in the neonatal period, often accompanied by respiratory failure. In addition to timely treatment, effective nursing...
BACKGROUND
Neonatal pneumonia is a common respiratory disease in the neonatal period, often accompanied by respiratory failure. In addition to timely treatment, effective nursing is essential.
OBJECTIVE
We attempted to determine the clinical effect of refined nursing applied to the nursing of patients with severe neonatal pneumonia accompanied by respiratory failure.
DESIGN
This was a randomized controlled study.
SETTING
This study was performed in the Neonatal Department, The First Hospital of China Medical University.
PARTICIPANTS
A total of 60 newborns with severe pneumonia and respiratory failure diagnosed and treated in the neonatal intensive care unit of our hospital between January 2022 and December 2022 were selected and assigned to either the control group (CG) or the experimental group (EG) based on the random number table method, with 30 patients in each group.
INTERVENTIONS
The CG received conventional nursing intervention and the EG received refined nursing intervention.
PRIMARY OUTCOME MEASURES
(1) Symptom improvement time; (2) blood gas indicators; (3) vital signs; (4) complication occurrence rate and (5) nursing satisfaction.
RESULTS
The improvement time of cough, shortness of breath and wheezing in the EG was decreased compared with the CG (P < .05). After nursing, the EG exhibited higher partial arterial oxygen pressure and blood oxygen saturation levels and lower partial arterial carbon dioxide pressure relative to the control group (P < .05). After nursing, the heart and respiratory rates in both groups were decreased compared with before nursing, and in the EG group were decreased in comparison with the CG (P < .05). The incidence of adverse events in the EG was lower in comparison with the CG (P < .05). Nursing satisfaction in the EG was higher compared with the CG.
CONCLUSION
The application of refined nursing in the clinical nursing of patients with neonatal pneumonia accompanied by respiratory failure can facilitate improvement in their condition, improve blood gas indicators and vital signs and prevent adverse events.
PubMed: 38940774
DOI: No ID Found