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Current Oncology (Toronto, Ont.) Jun 2024In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block...
How to Balance Prognostic Factors in Controlled Phase II Trials: Stratified Permuted Block Randomization or Minimization? An Analysis of Clinical Trials in Digestive Oncology.
In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block Randomization) and minimization. First, we provide a systematic review of the treatment allocation procedure used in gastrointestinal oncology controlled phase II trials published in 2019. Second, we performed simulations using data from six phase II studies to measure the impacts of imbalances and bias on the efficacy estimations. From the 40 articles analyzed, all mentioned randomization in both the title and abstract, the median number of patients included was 109, and 77.5% were multicenter. Of the 27 studies that reported at least one stratification variable, 10 included the center as a stratification variable, 10 used minimization, 9 used SBR, and 8 were unspecified. In real data studies, the imbalance increased with the number of centers. The total and marginal imbalances were higher with SBR than with minimization, and the difference increased with the number of centers. The efficiency estimates per arm were close to the original trial estimate in both procedures. Minimization is often used in cases of numerous centers and guarantees better similarity between arms for stratification variables for total and marginal imbalances in phase II trials.
Topics: Humans; Clinical Trials, Phase II as Topic; Prognosis; Randomized Controlled Trials as Topic; Gastrointestinal Neoplasms; Research Design; Digestive System Neoplasms
PubMed: 38920742
DOI: 10.3390/curroncol31060259 -
Indian Journal of Thoracic and... May 2024Infective endocarditis surgical patients suffer from high rates of severe complications such as systemic inflammatory response, septic shock, and multi-organ failure... (Review)
Review
UNLABELLED
Infective endocarditis surgical patients suffer from high rates of severe complications such as systemic inflammatory response, septic shock, and multi-organ failure leading to high mortality. Systemic inflammatory response based on cytokines as messengers plays an important role in these patients. The concept of intraoperative haemoadsorption has been proposed to remove such elevated cytokines in patients undergoing cardiac surgery for infective endocarditis. Haemoadsorption offers the possibility to stabilise haemodynamics, reduce sepsis-related mortality, and protect organ function. However, until now, there has been no general opinion and consensus regarding the clinical effectiveness of adjunctive intraoperative haemoadsorption in infective endocarditis. Therefore, we reviewed the current literature evaluating haemoadsorption in infective endocarditis patients undergoing cardiac surgery. The review was registered at PROSPERO (CRD42023457632).
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s12055-024-01701-0.
PubMed: 38827548
DOI: 10.1007/s12055-024-01701-0 -
BMC Cardiovascular Disorders May 2024Extracorporeal blood purification has been widely used in intensive care medicine, nephrology, toxicology, and other fields. During the last decade, with the emergence...
BACKGROUND
Extracorporeal blood purification has been widely used in intensive care medicine, nephrology, toxicology, and other fields. During the last decade, with the emergence of new adsorptive blood purification devices, hemoadsorption has been increasingly applied during CPB in cardiac surgery, for patients at different inflammatory risks, or for postoperative complications. Clinical evidence so far has not provided definite answers concerning this adjunctive treatment. The current systematic review aimed to critically assess the role of perioperative hemoadsorption in cardiac surgery, by summarizing the current knowledge in this clinical setting.
METHODS
A literature search of PubMed, Cochrane library, and the database provided by CytoSorbents was conducted on June 1st, 2023. The search terms were chosen by applying neutral search keywords to perform a non-biased systematic search, including language variations of terms "cardiac surgery" and "hemoadsorption". The screening and selection process followed scientific principles (PRISMA statement). Abstracts were considered for inclusion if they were written in English and published within the last ten years. Publications were eligible for assessment if reporting on original data from any type of study (excluding case reports) in which a hemoadsorption device was investigated during or after cardiac surgery. Results were summarized according to sub-fields and presented in a tabular view.
RESULTS
The search resulted in 29 publications with a total of 1,057 patients who were treated with hemoadsorption and 988 control patients. Articles were grouped and descriptively analyzed due to the remarkable variability in study designs, however, all reported exclusively on CytoSorb therapy. A total of 62% (18/29) of the included articles reported on safety and no unanticipated adverse events have been observed. The most frequently reported clinical outcome associated with hemoadsorption was reduced vasopressor demand resulting in better hemodynamic stability.
CONCLUSIONS
The role of hemoadsorption in cardiac surgery seems to be justified in selected high-risk cases in infective endocarditis, aortic surgery, heart transplantation, and emergency surgery in patients under antithrombotic therapy, as well as in those who develop a dysregulated inflammatory response, vasoplegia, or septic shock postoperatively. Future large randomized controlled trials are needed to better define proper patient selection, dosing, and timing of the therapy.
Topics: Humans; Cardiac Surgical Procedures; Treatment Outcome; Risk Factors; Postoperative Complications; Cardiopulmonary Bypass; Male; Female; Risk Assessment; Aged; Middle Aged
PubMed: 38762715
DOI: 10.1186/s12872-024-03938-4 -
International Journal of Medical... Jul 2024Human Emotion Recognition (HER) has been a popular field of study in the past years. Despite the great progresses made so far, relatively little attention has been paid... (Review)
Review
BACKGROUND
Human Emotion Recognition (HER) has been a popular field of study in the past years. Despite the great progresses made so far, relatively little attention has been paid to the use of HER in autism. People with autism are known to face problems with daily social communication and the prototypical interpretation of emotional responses, which are most frequently exerted via facial expressions. This poses significant practical challenges to the application of regular HER systems, which are normally developed for and by neurotypical people.
OBJECTIVE
This study reviews the literature on the use of HER systems in autism, particularly with respect to sensing technologies and machine learning methods, as to identify existing barriers and possible future directions.
METHODS
We conducted a systematic review of articles published between January 2011 and June 2023 according to the 2020 PRISMA guidelines. Manuscripts were identified through searching Web of Science and Scopus databases. Manuscripts were included when related to emotion recognition, used sensors and machine learning techniques, and involved children with autism, young, or adults.
RESULTS
The search yielded 346 articles. A total of 65 publications met the eligibility criteria and were included in the review.
CONCLUSIONS
Studies predominantly used facial expression techniques as the emotion recognition method. Consequently, video cameras were the most widely used devices across studies, although a growing trend in the use of physiological sensors was observed lately. Happiness, sadness, anger, fear, disgust, and surprise were most frequently addressed. Classical supervised machine learning techniques were primarily used at the expense of unsupervised approaches or more recent deep learning models. Studies focused on autism in a broad sense but limited efforts have been directed towards more specific disorders of the spectrum. Privacy or security issues were seldom addressed, and if so, at a rather insufficient level of detail.
Topics: Humans; Machine Learning; Emotions; Autistic Disorder; Facial Expression; Child
PubMed: 38723429
DOI: 10.1016/j.ijmedinf.2024.105469 -
BMC Health Services Research May 2024Healthcare staff deliver patient care in emotionally charged settings and experience a wide range of emotions as part of their work. These emotions and emotional... (Review)
Review
BACKGROUND
Healthcare staff deliver patient care in emotionally charged settings and experience a wide range of emotions as part of their work. These emotions and emotional contexts can impact the quality and safety of care. Despite the growing acknowledgement of the important role of emotion, we know very little about what triggers emotion within healthcare environments or the impact this has on patient safety.
OBJECTIVE
To systematically review studies to explore the workplace triggers of emotions within the healthcare environment, the emotions experienced in response to these triggers, and the impact of triggers and emotions on patient safety.
METHODS
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, four electronic databases were searched (MEDLINE, PsychInfo, Scopus, and CINAHL) to identify relevant literature. Studies were then selected and data synthesized in two stages. A quality assessment of the included studies at stage 2 was undertaken.
RESULTS
In stage 1, 90 studies were included from which seven categories of triggers of emotions in the healthcare work environment were identified, namely: patient and family factors, patient safety events and their repercussions, workplace toxicity, traumatic events, work overload, team working and lack of supervisory support. Specific emotions experienced in response to these triggers (e.g., frustration, guilt, anxiety) were then categorised into four types: immediate, feeling states, reflective, and longer-term emotional sequelae. In stage 2, 13 studies that explored the impact of triggers or emotions on patient safety processes/outcomes were included.
CONCLUSION
The various triggers of emotion and the types of emotion experienced that have been identified in this review can be used as a framework for further work examining the role of emotion in patient safety. The findings from this review suggest that certain types of emotions (including fear, anger, and guilt) were more frequently experienced in response to particular categories of triggers and that healthcare staff's experiences of negative emotions can have negative effects on patient care, and ultimately, patient safety. This provides a basis for developing and tailoring strategies, interventions, and support mechanisms for dealing with and regulating emotions in the healthcare work environment.
Topics: Humans; Emotions; Workplace; Patient Safety; Health Personnel
PubMed: 38720302
DOI: 10.1186/s12913-024-11011-1 -
Annals of Intensive Care Apr 2024Multiple randomized controlled studies have compared numerous antibiotic regimens, including new, recently commercialized antibiotics in the treatment of nosocomial...
BACKGROUND
Multiple randomized controlled studies have compared numerous antibiotic regimens, including new, recently commercialized antibiotics in the treatment of nosocomial pneumonia (NP). The objective of this Bayesian network meta-analysis (NMA) was to compare the efficacy and the safety of different antibiotic treatments for NP.
METHODS
We conducted a systematic search of PubMed, Medline, Web of Science, EMBASE and the Cochrane Library databases from 2000 through 2021. The study selection included studies comparing antibiotics targeting Gram-negative bacilli in the setting of NP. The primary endpoint was 28 day mortality. Secondary outcomes were clinical cure, microbiological cure and adverse events.
RESULTS
Sixteen studies encompassing 4993 patients were included in this analysis comparing 13 antibiotic regimens. The level of evidence for mortality comparisons ranged from very low to moderate. No significant difference in 28 day mortality was found among all beta-lactam regimens. Only the combination of meropenem plus aerosolized colistin was associated with a significant decrease of mortality compared to using intravenous colistin alone (OR = 0.43; 95% credible interval [0.17-0.94]), based on the results of the smallest trial included. The clinical failure rate of ceftazidime was higher than meropenem with (OR = 1.97; 95% CrI [1.19-3.45]) or without aerosolized colistin (OR = 1.40; 95% CrI [1.00-2.01]), imipemen/cilastatin/relebactam (OR = 1.74; 95% CrI [1.03-2.90]) and ceftazidime/avibactam (OR = 1.48; 95% CrI [1.02-2.20]). For microbiological cure, no substantial difference between regimens was found, but ceftolozane/tazobactam had the highest probability of being superior to comparators. In safety analyses, there was no significant difference between treatments for the occurrence of adverse events, but acute kidney failure was more common in patients receiving intravenous colistin.
CONCLUSIONS
This network meta-analysis suggests that most antibiotic regimens, including new combinations and cefiderocol, have similar efficacy and safety in treating susceptible Gram-negative bacilli in NP. Further studies are necessary for NP caused by multidrug-resistant bacteria. Registration PROSPERO CRD42021226603.
PubMed: 38662091
DOI: 10.1186/s13613-024-01291-5 -
RMD Open Apr 2024This international task force aimed to provide healthcare professionals and persons living with systemic lupus erythematosus (SLE) with consensus-based recommendations...
OBJECTIVE
This international task force aimed to provide healthcare professionals and persons living with systemic lupus erythematosus (SLE) with consensus-based recommendations for physical activity and exercise in SLE.
METHODS
Based on evidence from a systematic literature review and expert opinion, 3 overarching principles and 15 recommendations were agreed on by Delphi consensus.
RESULTS
The overarching principles highlight the importance of shared decision-making and the need to explain the benefits of physical activity to persons living with SLE and other healthcare providers. The 15 specific recommendations state that physical activity is generally recommended for all people with SLE, but in some instances, a medical evaluation may be needed to rule out contraindications. Pertaining to outdoor activity, photoprotection is necessary. Both aerobic and resistance training programmes are recommended, with a gradual increase in frequency and intensity, which should be adapted for each individual, and ideally supervised by qualified professionals.
CONCLUSION
In summary, the consensus reached by the international task force provides a valuable framework for the integration of physical activity and exercise into the management of SLE, offering a tailored evidence-based and eminence-based approach to enhance the well-being of individuals living with this challenging autoimmune condition.
Topics: Humans; Consensus; Lupus Erythematosus, Systemic; Exercise; Advisory Committees
PubMed: 38580348
DOI: 10.1136/rmdopen-2024-004171 -
Journal of Affective Disorders Jun 2024In recent years, there has been a wide array of research studies published on parental mental health and stress following very preterm birth. This review aims at... (Review)
Review
BACKGROUND
In recent years, there has been a wide array of research studies published on parental mental health and stress following very preterm birth. This review aims at reviewing the prevalence and risk factors of long-term parental depression, anxiety, post-traumatic stress symptoms and parenting stress following very preterm birth.
METHODS
We searched PubMed, PsychINFO and Web of Science for descriptive, cross-sectional and longitudinal studies published between January 2013 and August 2022.
RESULTS
45 studies met our inclusion criteria. In the first two years, depression, anxiety, post-traumatic stress symptoms and parenting stress were present in ∼20 % of mothers of extreme and very low birth weight (E/VLBW) infants. Long-term psychological distress symptoms could be observed, although few studies have focused on symptoms into school age and longer. Fathers of VLBW infants might experience more psychological distress as well, however, they were only included in ten studies. We found that parental distress is more common when the co-parent is struggling with mental health symptoms. Many risk factors were identified such as social risk, history of mental illness, interpersonal factors (i.e. social support) and child-related factors (i.e. intraventricular hemorrhage, disability, use of medical equipment at home).
LIMITATIONS
Several studies have methodological issues, such as a lack of control of known confounders and there is a large variety of measures employed.
CONCLUSION
Important risk factors for stress and mental health symptoms were identified. More evidence is needed to determine if long-term symptoms persist into school age. Research should focus on taking a family-based approach in order to identify preventive strategies and resilience factors in parents of VLBW infants.
Topics: Infant; Female; Infant, Newborn; Humans; Premature Birth; Infant, Premature; Cross-Sectional Studies; Mothers; Parents; Outcome Assessment, Health Care; Stress, Psychological
PubMed: 38556094
DOI: 10.1016/j.jad.2024.03.154 -
Scandinavian Journal of Public Health Mar 2024This systematic review aims to identify and describe how children of parents with mental illness, substance dependence, or severe physical illness/injury, experience... (Review)
Review
This systematic review aims to identify and describe how children of parents with mental illness, substance dependence, or severe physical illness/injury, experience and practise their everyday life. The review followed the four stepwise recommendations of Harden and colleagues when including quantitative and qualitative studies on peoples' experiences and views. In all, 23 studies with data from Norway (2010-2022) have been included. Brown and Clark's thematic analysis was applied. Three themes were constructed from the reviewed articles: (a) Children practice their relational agency by actively doing practical tasks, occasionally jobs to maintain family economy, and organising fun activities with the ill parent. (b) Emotional ambivalence when their own needs were set aside in favour of the parents. They loved their parents but also felt guilt, anger, disappointment, shame, fear of inheriting the illness and longed for a 'normal' everyday life. (c) Supportive contextual factors were, for example, at least one significant adult recognising them, participating in leisure activities, socialising with friends, and talking with other peers who shared similar experiences as next of kin. Obstructive factors were lack of information and recognition as well as silence and lack of dialogue within the family and/or health professional.
PubMed: 38506846
DOI: 10.1177/14034948241232040 -
American Journal of Public Health Feb 2024Mental health is declining in health care workers. To provide a comprehensive assessment of intervention literature focused on the support and treatment of mental...
Mental health is declining in health care workers. To provide a comprehensive assessment of intervention literature focused on the support and treatment of mental health within the health care workforce. We searched online databases (e.g., Medline, PsycINFO). We selected manuscripts published before March 2022 that evaluated the target population (e.g., nurses), mental health outcomes (e.g., burnout, depression), and intervention category (e.g., mindfulness). Of 5158 publications screened, 118 interventions were included. We extracted relevant statistics and information. Twenty (17%) earned study quality ratings indicating design, analysis, and implementation strengths. Randomized controlled trials were used by 52 studies (44%). Thirty-eight percent were conducted in the United States (n = 45). Ninety (76%) reported significant changes, and 46 (39%) reported measurable effect sizes. Multiple interventions significantly reduced stress (n = 29; 24%), anxiety (n = 20; 17%), emotional exhaustion or compassion fatigue (n = 16; 14%), burnout (n = 15; 13%), and depression (n = 15; 13%). Targeted, well-designed mental health interventions can improve outcomes among health care workers. Targeted health care‒focused interventions to address workers' mental health could improve outcomes within this important and vulnerable workforce. (. 2024;114(S2):S213-S226. https://doi.org/10.2105/AJPH.2023.307556).
Topics: Humans; Mental Health; Evidence-Based Medicine; Health Personnel; Anxiety; Delivery of Health Care
PubMed: 38354343
DOI: 10.2105/AJPH.2023.307556