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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 -
Psychological Bulletin Jun 2024Although trauma-focused psychotherapy (T-F psychotherapy) is the treatment of choice for posttraumatic stress disorder (PTSD), up to one half of patients do not respond...
Although trauma-focused psychotherapy (T-F psychotherapy) is the treatment of choice for posttraumatic stress disorder (PTSD), up to one half of patients do not respond to this treatment. Attempts to improve response to T-F psychotherapy have focused on augmenting fear extinction-based factors. Here, a systematic and meta-analytic review of predictors of T-F psychotherapy outcome was conducted with the goal of using an aggregate data-driven approach to elucidate baseline factors associated with treatment outcome. There were 114 studies that met inclusion criteria ( = 61, 970; = 40.1 years; 40.1% female). There were 237 effect sizes across 24 meta-analytic categories. Poorer treatment response is associated with lower pretreatment levels of activation of fear-related brain regions, psychophysiological reactivity to fear provocation, trauma-related cognitions, anger, depression, high-risk alleles of genes linked to fear, lower levels of executive control, and social support. A range of other factors also predicted poorer responses including being male, non-Caucasian, older in age, early trauma occurrence, more trauma experience, history of combat trauma, as well as comorbid sleep, pain, poor quality life, and alcohol abuse difficulties. This review provides one potential explanation for the limited success of T-F psychotherapy augmentation strategies that have focused only on fear circuity mechanisms at the exclusion of other factors. Here, poor response relating to predictors of early trauma onset and comorbidity are consistent with clinical presentations of complex PTSD, which may suggest T-F psychotherapy is less effective for this condition. This collective evidence suggests that clinicians should consider a tailored approach that targets potential barriers to successful treatment response. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
PubMed: 38884956
DOI: 10.1037/bul0000438 -
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 -
La Revue de Medecine Interne May 2024Patients with cancer are at significantly increased risk of venous thromboembolism (VTE), due both to the impact of malignant disease itself and to the impact of certain... (Review)
Review
Patients with cancer are at significantly increased risk of venous thromboembolism (VTE), due both to the impact of malignant disease itself and to the impact of certain anticancer drugs on haemostasis. This is true both for first episode venous thromboembolism and recurrence. The diagnosis and management of VTE recurrence in patients with cancer poses particular challenges, and these are reviewed in the present article, based on a systematic review of the relevant scientific literature published over the last decade. Furthermore, it is uncertain whether diagnostic algorithms for venous thromboembolism, validated principally in untreated non-cancer patients, are also valid in anticoagulated cancer patients: the available data suggests that clinical decision rules and D-dimer testing perform less well in this clinical setting. In patients with cancer, computed tomography pulmonary angiography and venous ultrasound appear to be the most reliable diagnostic tools for diagnosis of pulmonary embolism and deep vein thrombosis respectively. Options for treatment of venous thromboembolism include low molecular weight heparins (at a therapeutic dose or an increased dose), fondaparinux or oral direct factor Xa inhibitors. The choice of treatment should take into account the nature (pulmonary embolism or VTE) and severity of the recurrent event, the associated bleeding risk, the current anticoagulant treatment (type, dose, adherence and possible drug-drug interactions) and cancer progression.
Topics: Humans; Venous Thromboembolism; Neoplasms; Anticoagulants; Recurrence; France
PubMed: 38806295
DOI: 10.1016/j.revmed.2024.05.017 -
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 -
The Annals of Pharmacotherapy Apr 2024This systematic literature review aims to evaluate the effectiveness of transdermal opioids in managing cancer pain and their impact on the quality of life (QoL) of... (Review)
Review
OBJECTIVE
This systematic literature review aims to evaluate the effectiveness of transdermal opioids in managing cancer pain and their impact on the quality of life (QoL) of patients.
DATA SOURCES
A systematic literature review conducted following the PRISMA protocol, focusing on randomized clinical trials found in the Lilacs, Embase, PubMed, and SciELO databases over the last 20 years.
STUDY SELECTION AND DATA EXTRACTION
We included randomized clinical trials, published in English, Portuguese, or Spanish, which assessed the impact of transdermal opioids on the QoL. Data extraction was facilitated using the Rayyan app.
DATA SYNTHESIS
Six articles meeting the inclusion and exclusion criteria were analyzed. These studies covered a population ranging from 24 to 422 cancer patients experiencing moderate to severe pain. The risk of bias was assessed in each study, generally being categorized as uncertain or high.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
The findings indicate that the analgesic effectiveness and side effects of transdermal formulations (specifically buprenorphine and fentanyl) for managing moderate to severe cancer pain are comparable to, or in some cases superior to, those of oral opioids traditionally employed.
CONCLUSIONS
Transdermal therapy was suggested to have several advantages over oral opioid therapy in enhancing cancer patients' QoL. These benefits span various dimensions, including pain management, physical functioning, mental health, vitality, overall patient improvement, anger/aversion, strength/activity, general QoL, cognitive and emotional functions, fatigue, and insomnia.
PubMed: 38659244
DOI: 10.1177/10600280241247363 -
Maturitas Jul 2024The association between cognitive disorders and orthostatic hypotension (OH) has been empirically explored, but the results have been divergent, casting doubt on the... (Meta-Analysis)
Meta-Analysis Review
The association between cognitive disorders and orthostatic hypotension (OH) has been empirically explored, but the results have been divergent, casting doubt on the presence and direction of the association. The objective of this meta-analysis was to systematically review and quantitatively synthesize the association of OH and cognitive function, specifically mean score on the Mini-Mental State Examination (MMSE), cognitive impairment and incident dementia. A Medline search was conducted in May 2022 with no date limit, using the MeSH terms "orthostatic hypotension" OR "orthostatic intolerance" OR "hypotension" combined with the Mesh terms "cognitive dysfunction" OR "Alzheimer disease" OR "dementia" OR "cognition disorder" OR "neurocognitive disorder" OR "cognition" OR "neuropsychological test". Of the 746 selected studies, 15 longitudinal studies met the selection criteria, of which i) 5 studies were eligible for meta-analysis of mean MMSE score comparison, ii) 5 studies for the association of OH and cognitive impairment, and iii) 6 studies for the association between OH and incident dementia. The pooled effect size in fixed-effects meta-analysis was: i) -0.25 (-0.42; -0.07) for the mean MMSE score, which indicates that the MMSE score was lower for those with OH; ii) OR (95 % CI) = 1.278 (1.162; 1.405), P < 0.0001, indicating a 28 % greater risk of cognitive impairment for those with OH at baseline; and iii) HR (95 % CI) = 1.267 (1.156; 1.388), P < 0.0001, indicating a 27 % greater risk of incident dementia for those with OH at baseline. Patients with OH had a lower MMSE score and higher risk of cognitive impairment and incident dementia in this meta-analysis of longitudinal studies. This study confirmed the presence of an association between OH and cognitive disorders in older adults.
Topics: Humans; Hypotension, Orthostatic; Cognitive Dysfunction; Dementia; Longitudinal Studies; Mental Status and Dementia Tests
PubMed: 38604094
DOI: 10.1016/j.maturitas.2023.107866