Positive Study Outcome Research Articles

Applications of Platelet Concentrates (PCs) in Regenerative Onco-Urology: A Systematic Review of Literature

Objective: To assess the effectiveness of Platelet Concentrates (PCs) in the contest of Hemorrhagic, Actinic, and Radiation Cystitis, plus Urethral Obstruction or Stenosis. Eligibility criteria: Open article in English or Italian regarding in situ applications of PCs for the selected pathologies. Information sources: MEDLINE, Cochrane Library, and ELSEVIER. Risk of bias: High (and discussed). Methods for synthesis of results: Selection of relevant contents, resumed by digital tools, checked by authors and used throughout the manuscript. Included studies: 13 screened articles + 7 personal sources + 37 “extra” articles. Synthesis of results: Pre-clinical and clinical studies demonstrated substantial symptom relief, mucosal restoration, and improved growth factor levels, reducing recurrence rates and complications. However, preparation protocols and results varied among studies. Limitations of evidence: Frequent low-quality studies with mall sample size, plus heterogeneous experimental setups and nomenclature/preparations. Interpretation: PCs demonstrate promise due to their bioactive components, enhancing tissue repair and reducing inflammation with no significant adverse events. Despite positive outcomes in pre-clinical and clinical studies, variability in preparation protocols and small sample sizes, together with inconsistent results, highlight the need for high-quality research to validate PCs’ clinical efficacy and cost-effectiveness.

Ndufs4 knockout mice with isolated complex I deficiency engage a futile adaptive brain response

Paediatric Leigh syndrome (LS) is an early-onset and fatal neurodegenerative disorder lacking treatment options. LS is frequently caused by mutations in the NDUFS4 gene, encoding an accessory subunit of mitochondrial complex I (CI), the first complex of the oxidative phosphorylation (OXPHOS) system. Whole-body Ndufs4 knockout (KO) mice (WB-KO mice) are widely used to study isolated CI deficiency, LS pathology and interventions. These animals develop a brain-specific phenotype via an incompletely understood pathomechanism. Here we performed a quantitative analysis of the sub-brain proteome in six-weeks old WB-KO mice vs. wildtype mice. Brain regions comprised of a brain slice (BrSl), cerebellum (CB), cerebral cortex (CC), hippocampus (HC), inferior colliculus (IC), and superior colliculus (SC). Proteome analysis demonstrated similarities between CC/HC, and between IC/SC, whereas BrSl and CB differed from these two groups and each other. All brain regions displayed greatly reduced levels of two CI structural subunits (NDUFS4, NDUFA12) and an increased level of the CI assembly factor NDUFAF2. The level of CI-Q module subunits was significantly more reduced in IC/SC than in BrSl/CB/CC/HC, whereas other OXPHOS complex levels were not reduced. Gene ontology and pathway analysis demonstrated specific and common proteome changes between brain regions.Across brain regions, upregulation of cold-shock-associated proteins, mitochondrial fatty acid (FA) oxidation and synthesis (mtFAS) were the most prominent. FA-related pathways were predominantly upregulated in CB and HC. Based upon these results, we argue that stimulation of these pathways is futile and pro-pathological and discuss alternative strategies for therapeutic intervention in LS. SignificanceThe Ndufs4 knockout mouse model is currently the most relevant and most widely used animal model to study the brain-linked pathophysiology of human Leigh Syndrome (LS) and intervention strategies. We demonstrate that the Ndufs4 knockout brain engages futile and pro-pathological responses. These responses explain both negative and positive outcomes of intervention studies in Leigh Syndrome mice and patients, thereby guiding novel intervention opportunities.

Characteristics and Impact of Randomized Trials on Drugs or Devices in Cardiovascular Medicine.

Clinical trials, essential for medical advancement, vary significantly in methodology and regulatory pathways depending on the type of therapeutic intervention (i.e., drugs or devices). This study aimed to determine whether the drug or device intervention types influence the impact of randomized trials in cardiovascular medicine. We analyzed late-breaking randomized controlled trials presented at major cardiology conferences from 2015 to 2021. The primary endpoint was the total number of citations obtained. Secondary endpoints included the number of citations at 1 and 2 years, number of total and 1-year mentions, and several metrics of study conduct and publication. Statistical analysis included tests for comparisons of continuous or categorical variables, based on their distribution, as appropriate. To adjust the results for potential confounders, univariable and multivariable regression models were utilized. Additionally, sensitivity analyses were conducted to explore both the effect of neutral or positive study outcomes on the comparative impact of drug versus device trials and the impact of the coronavirus disease 2019 (COVID-19) pandemic on the primary endpoint. Of 382 eligible randomized trials, 227 (59.4%) were trials of drugs and 155 (40.6%) were trials of devices. Drug trials had a higher median number of total citations compared to device studies (93 [interquartile range {IQR} 48-137] vs. 82 [IQR 39-192]; p = 0.025). This difference was consistent at 1 and 2 years and was also observed in the number of total mentions and mentions at 1 year. All the metrics of study conduct and publication were similar, except for drug studies being more often stopped prematurely (8.8 vs. 1.9%; p = 0.006). After adjusting for multiple potential confounders, the difference in citations and mentions was no longer statistically significant. However, drug trials remained more likely to be stopped prematurely (adjusted odds ratio = 1.15; 95% confidence interval 1.03-1.28; p = 0.009). Positive study outcomes significantly influenced the number of citations and the likelihood of a trial being stopped prematurely. Drug trials are often stopped early and receive more citations and mentions than device trials. However, these differences are mainly due to factors other than the treatment itself. Studies published simultaneously tend to get more attention, and drug trials with positive results are cited more often than those with neutral results.

Effects of Vibration on Accelerating Orthodontic Tooth Movement in Clinical and In Vivo Studies: A Systematic Review.

This systematic review aims to assess the impact of high (>30 Hz) and low (≤30 Hz) frequency vibrations on orthodontic tooth movement (OTM). Several articles were collected through a systematic search in the databases MEDLINE and SCOPUS, following PRISMA methodology and using a PICO question. Relevant information on selected articles was extracted, and the quality of each study was assessed by the quality assessment tools EPHPP, ROBINS-1 and STAIR. Out of 350 articles, 30 were chosen. Low-frequency vibrations did not seem to accelerate OTM with aligners or fixed appliances, despite some positive outcomes in certain studies. Conversely, high-frequency vibrations were linked to increased aligner change, tooth movement, and space closure with fixed appliances. In vivo studies reported favourable results with high-frequency vibrations (60 Hz to 120 Hz), which stimulate bone biomarkers, facilitating alveolar bone remodelling. The results suggest that high-frequency vibration effectively speeds up orthodontic tooth movement, showing promise in both in vivo and clinical studies. Larger-scale research is needed to strengthen its potential in orthodontics.

Indigo Naturalis in Inflammatory Bowel Disease: mechanisms of action and insights from clinical trials.

This study investigates the therapeutic potential of Indigo Naturalis (IN) in treating a Inflammatory Bowel Disease (IBD). The objective is to comprehensively examine the effects and pharmacological mechanisms of IN on IBD, assessing its potential as an novel treatment for IBD. Analysis of 11 selected papers is conducted to understand the effects of IN, focusing on compounds like indirubin, isatin, indigo, and tryptanthrin. This study evaluates their impact on Disease Activity Index (DAI) score, colon length, mucosal damage, and macrophage infiltration in Dextran Sulfate Sodium (DSS)-induced colitis mice. Additionally, It investigate into the anti-inflammatory mechanisms, including Aryl hydrocarbon Receptor (AhR) pathway activation, Nuclear Factor kappa B (NF-κB)/nod-like receptor family pyrin domain containing 3 (NLRP3)/Interleukin 1 beta (IL-1β) inhibition, and modulation of Toll-like receptor 4 (TLR4)/myeloid differentiation primary response 88 (MYD88)/NF-κB and Mitogen Activated Protein Kinase (MAPK) pathways. Immunomodulatory effects on T helper 17 (Th17)/regulatory T cell (Treg cell) balance and Glycogen synthase kinase-3 beta (GSK3-β) expression are also explored. Furthermore, the study addresses the role of IN in restoring intestinal microbiota diversity, reducing pathogenic bacteria, and increasing beneficial bacteria. The findings reveal that IN, particularly indirubin and indigo, demonstrates significant improvements in DAI score, colon length, mucosal damage, and macrophage infiltration in DSS-induced colitis mice. The anti-inflammatory effects are attributed to the activation of the AhR pathway, inhibition of inflammatory pathways, and modulation of immune responses. These results exhibit the potential of IN in IBD treatment. Notably, the restoration of intestinal microbiota diversity and balance further supports its efficacy. IN emerges as a promising and effective treatment for IBD, demonstrating anti-inflammatory effects and positive outcomes in preclinical studies. However, potential side effects necessitate further investigation for safe therapeutic development. The study underscores the need for future research to explore a broader range of active ingredients in IN to enhance therapeutic efficacy and safety.

Reducing Disruptive and Distracting Behaviors in the Classroom: Assessing the Evidence Base.

Disruptive and distracting behaviors in the classroom, from off-task to aggressive behaviors, negatively affect academic engagement and achievement and can lead to more serious problems, including mental health conditions and substance use disorders. The goals of this systematic review were to assess the level of evidence, using established rating criteria, for interventions aimed at preventing or reducing disruptive and distracting classroom behaviors; identify program components common to multiple interventions; synthesize the evidence in regard to students from different racial-ethnic groups; and conduct an economic analysis of these interventions. A search of major databases, gray literature, and evidence base registries was conducted to identify studies published between 2008 and 2022. The authors rated interventions as having high, moderate, or low levels of evidence of effectiveness on the basis of the number and rigor of studies with positive outcomes. Of the 27 interventions identified across 65 studies (N=73 articles), six interventions received a high or moderate evidence rating. The Good Behavior Game was the most frequently studied intervention. Many interventions shared similar program components, including behavioral management, classroom management, emotional-cognitive processes, and skills acquisition. Most articles (86%) were focused on elementary school students. The four interventions rated as having high evidence of effectiveness also showed generally positive outcomes in studies conducted in school settings with racial-ethnic diversity. No studies met the criteria for inclusion in an economic analysis. With greater use and more research, interventions focusing on reducing disruptive and distracting behaviors have the potential to promote student well-being and prevent mental health conditions.

Probiotic formulations and gastro-intestinal diseases in the paediatric population: a narrative review.

Probiotics are live microbial supplements that improve the microbial balance in the host animal when administered in adequate amounts. They play an important role in relieving symptoms of many diseases associated with gastrointestinal tract, for example, in necrotizing enterocolitis (NEC), antibiotic-associated diarrhea, relapsing Clostridium difficile colitis, Helicobacter pylori infections, and inflammatory bowel disease (IBD). In this narrative review, the authors aim to evaluate the role of different probiotic formulations in treating gastrointestinal diseases in pediatric population aged 18 years or younger and highlight the main considerations for selecting probiotic formulations for use in this population. The authors searched PubMed and Clinicaltrials.gov from inception to 24th July 2022, without any restrictions. Using an iterative process, the authors subsequently added papers through hand-searching citations contained within retrieved articles and relevant systematic reviews and meta-analyses. The effectiveness of single-organism and composite probiotics in treating gastrointestinal disorders in pediatric patients aged 18 or under were analyzed and compared in this study. A total of 39 studies were reviewed and categorized based on positive and negative outcomes, and compared with a placebo, resulting in 25 studies for single-organism and 14 studies for composite probiotics. Gastrointestinal disorders studied included NEC, acute gastroenteritis (AGE), Acute Diarrhea, Ulcerative Colitis (UC), and others. The results show that probiotics are effective in treating various gastrointestinal disorders in children under 18, with single-organism probiotics demonstrating significant positive outcomes in most studies, and composite probiotics showing positive outcomes in all studies analyzed, with a low incidence of negative outcomes for both types. This study concludes that single-organism and composite probiotics are effective complementary therapies for treating gastrointestinal disorders in the pediatric population. Hence, healthcare professionals should consider using probiotics in standard treatment regimens, and educating guardians can enhance the benefits of probiotic therapy. Further research is recommended to identify the optimal strains and dosages for specific conditions and demographics. The integration of probiotics in clinical practice and ongoing research can contribute to reducing the incidence and severity of gastrointestinal disorders in pediatric patients.

Wound Healing Outcomes Following Treatment With Synthetic Hybrid-Scale Fiber Matrix After Resection of Soft Tissue Tumors or Infections

Background. Wide excision of soft tissue tumors or infections often results in large defects that can be challenging to manage. Advanced treatment modalities—including NPWT, skin grafts, and xenografts—can all be considered for post-resection wound management, but each has its limitations. An SHSFM, engineered to resemble human extracellular matrix, has demonstrated positive wound healing outcomes in prior studies. Materials and Methods. Adult patients at a single institution who underwent resection of soft tissue tumor or infected tissue followed by treatment with SHSFM from 2020-2023 were retrospectively reviewed. Results. Ten patients were included in the review after meeting the inclusion criteria. Overall, 7 of 10 wounds had documented complete closure, with 3 lost to follow-up. Average time to wound closure was 119 days. Patients either healed via secondary intention or were bridged to a split-thickness skin graft. The average VSS score was 3.3 when assessed. Conclusion. The current case series demonstrated that the SHSFM can support granulation tissue formation over exposed structures as a bridge to skin graft or can completely reepithelialize large wounds without skin grafting. The SHSFM offers a novel treatment option for post-resection surgical wounds.

Claudins in genitourinary tract neoplasms: mechanisms, prognosis, and therapeutic prospects.

Genitourinary (GU) cancers are among the most prevalent neoplasms in the world, with bladder cancers constituting 3% of global cancer diagnoses. However, several pathogenetic mechanisms remain controversial and unclear. Claudins, for example, have been shown to play a significant role in several cancers of the human body. Their role in GU cancers has not been extensively studied. Aberrant expression of claudins -1, -2, -3, -4, -7, and -11 has been expressed in urothelial cell carcinomas. In prostate cancers, altered levels of claudins -1, -2, -3, -4, and -5 have been reported. Furthermore, the levels of claudins -1, -2, -3, -4, -6, -7, -8, and -10 have been studied in renal cell carcinomas. Specifically, claudins -7 and -8 have proven especially useful in differentiating between chromophobe renal cell carcinomas and oncocytomas. Several of these claudins also correlate with clinicopathologic parameters and prognosis in GU cancers. Although mechanisms underpinning aberrant expression of claudins in GU cancers are unclear, epigenetic changes, tumor necrosis factor-ɑ, and the p63 protein have been implicated. Claudins also provide therapeutic value through tailored immunotherapy via molecular subtyping and providing therapeutic targets, which have shown positive outcomes in preclinical studies. In this review, we aim to summarize the literature describing aberrant expression of claudins in urothelial, prostatic, and renal cell carcinomas. Then, we describe the mechanisms underlying these changes and the therapeutic value of claudins. Understanding the scope of claudins in GU cancers paves the way for several diagnostic, prognostic, and therapeutic innovations.

A Novel Therapeutic Method in Gastro-esophageal Reflux Disease.

Gastro-esophageal reflux disease (GERD/GORD) is a chronic condition in which gastric acid flows backwards up into the esophagus, causing heart burn and a higher disposition to esophageal cancer. The reflux is caused by impairment of the lower esophageal sphincter (LES). Over the past century gastro-esophageal reflux has become the principal gastrointestinal condition of our time. The proton pump inhibitor class of drugs is effective in ameliorating the symptoms of reflux. The cost of investigation of patients in Europe is €100 billion per annum. The cost in days lost from work is €100 billion per annum in Europe. The global cost is 3 times this amount. The proposed device for treating gastro-esophageal reflux is a biodegradable valve that is placed non surgically in the esophago-gastric junction to prevent reflux from the stomach to the esophagus. 50 simulator studies were performed with the patented device to elucidate the most consistent method of insertion and fixation in a human like simulator. The simulator was designed to replicate the normal human gastro-esophageal anatomy and characteristics. Four animal insertions were performed under ethical regulation at Amsterdam Medical Centre, Netherlands. Three cadaveric experiments were performed at Hackensack University Hospital, New Jersey, USA, to verify the positive outcomes of the simulator studies. Successful outcomes of simulator studies and cadaveric experiments allowed the design freeze of a NoReflux device for treating gastro-esophageal reflux disease.

INNV-31. ADOPTING TUMOR TREATING FIELDS (TTFIELDS) THERAPY FOR GLIOBLASTOMA AND OTHER SOLID CANCERS: CHALLENGES AND OPPORTUNITIES

Abstract Tumor Treating Fields (TTFields) are alternating electric fields generated by a wearable medical device (NovoTTF-200A), delivered to the tumor target by arrays placed on the skin. These fields have multiple biological effects on tumor cells, including mitotic disruption, dysregulated DNA repair, antimigratory effects, and stimulation of antitumor immune response. TTFields therapy was approved for recurrent and newly diagnosed glioblastoma, based on the randomized, pivotal EF-11 and EF-14 studies, respectively. Data from both studies demonstrated favorable outcomes, sustained quality of life, and tolerable safety profile. Side effects are limited to mostly manageable, mild to moderate skin reactions with no increased systemic toxicity. TTFields therapy is also approved for pleural mesothelioma and has met the primary endpoint in the pivotal LUNAR study for metastatic non-small cell lung cancer patients. Despite extensive preclinical data, positive clinical study outcomes, and favorable real-world evidence, adoption of TTFields therapy remains tepid. Here we discuss potential causes and possible solutions to treatment barriers. Based on extensive surveys in the field, we have identified several potential reasons. The first challenge is the perception that open-label studies are less rigorous since sham devices are not used per protocol. The purpose of sham treatments in trials is to minimize placebo effects and/or investigator bias, but RANO criteria is designed to guard against just that. Secondly, dissemination of knowledge underlying innovative therapies often takes time. Unlike chemotherapy and radiotherapy, the mechanistic aspects of TTFields are not typically included in oncology training. Lastly, the benefits of TTFields therapy may be difficult to appreciate due to the required chronic use during maintenance. Therefore, education, additional bench research, and future clinical studies are important for a better adoption of this increasingly important oncological option.

Exploring the Lifecycle, Pathophysiology, and Potential Therapeutic Applications of the Reovirus

The Reoviridae family of double-stranded RNA viruses includes Reovirus. Both humans and animals might become sick from it. Even though they are often benign, certain strains have been connected to significant illnesses. This review investigates the virus's structure, replication, pathogenesis, clinical significance, and potential therapies. Its unusual capsid form is made up of a segmented genome that encodes twelve proteins and two concentric protein shells. Replication involves uncoating, receptor binding, endocytosis, genome transcription, and cytoplasmic translation. Reovirus masterfully manipulates its host's cellular functions, inducing apoptosis and stress responses that help it spread and multiply. Recently, encephalitis, myocarditis, and maybe even certain cancers have been linked to reovirus, which often produces mild respiratory or gastrointestinal symptoms. To fully understand the viral-host interactions producing these illnesses, further research is necessary. Particularly, the reovirus has promise for oncolytic virotherapy. Whether used alone or in conjunction with other medicines, a range of cancer types have showed positive outcomes in clinical studies. In essence, reovirus is a versatile pathogen that has intimate relationships with its hosts. To realize its therapeutic potential and shed light on its pathogenesis, one must have a complete grasp of its molecular and cellular connections. Unlocking the virus's potential is necessary to predict how it will impact both human and animal health.

Invited Commentary: Advancing but not yet Advanced: Assessment of Effort/Malingering in Forensic and Clinical Settings.

Neuropsychologists' conclusions and courtroom testimony on malingering can have profound impact. Intensive and ingenious research has advanced our capacities to identify both insufficient and sufficient effort and thus make worthy contributions to just conflict resolution. Nevertheless, given multiple converging factors, such as misleadingly high accuracy rates in many studies, practitioners may well develop inflated confidence in methods for evaluating effort/malingering. Considerable research shows that overconfidence often increases diagnostic and predictive error and may lead to fixed conclusions when caution is better advised. Leonhard's work thus performs an important service by alerting us to methodological considerations and shortcomings that can generate misimpressions about the efficacy of effort/malingering assessment. The present commentary covers various additional complicating factors in malingering assessment, including other factors that also inflate confidence; subtle and perhaps underappreciated methodological flaws that are inversely related to positive study outcomes (i.e., the worse the flaws the better methods appear to be); oversimplified classifications schemes for studying and evaluating effort that overlook, for example, common mixed presentations (e.g., malingering and genuinely injured); and the need to expand research across a greater range and severity of neuropsychological conditions and diverse groups. More generally, although endorsing various points that Leonhard raises, a number of questions and concerns are presented, such as methods for calculating the impact of case exclusions in studies. Ultimately, although Leonhard's conclusions may be more negative than is justified, it seems fair to categorize methods for assessing malingering/effort as advancing, but not yet advanced, with much more needed to be done to approach that latter status.

Comment: Group Sequential Designs with Response-Adaptive Randomisation

Group sequential Phase III trial designs enable early stopping for positive or negative study outcomes. Response-adaptive randomisation can be included in such designs with the sampling ratio in each group of subjects determined by the current treatment effect estimate. We demonstrate the potential of adaptive randomisation to reduce the number of patients receiving the inferior treatment, even when there is a delay in observing each patient’s response. We also observe that using a fixed but unequal sampling ratio may offer a simpler way to achieve the same objectives.

Strategies for Treatment of Thyroid Cancer.

More people are diagnosed with thyroid cancer than any other endocrine tumor. Differentiated thyroid cancer is often treated by removing the thyroid gland (thyroidectomy), iodizing radiation, or inhibiting thyroid stimulating hormone (TSH). Advanced thyroid carcinomas are notoriously resistant to chemotherapy, thus the pursuit of alternative treatments is vital. The best methods for treating individuals with advanced nonmedullary and medullary thyroid carcinomas are discussed in this post. Numerous tyrosine kinase inhibitors and antiangiogenic inhibitors, two types of novel target therapy, have shown promise in studies for individuals with thyroid cancer. Both the positive and unfavourable outcomes of clinical studies of these drugs were addressed. The findings presented here are encouraging, but more study is required to establish whether or not this method is effective in the treatment of thyroid cancer.

Virtual and in vitro, in vivo Screening of Transition Metal Complexes of N,N-Chelating Ligand: Experimental and Theoretical Investigations

Several transition metal complexes [ML(phth)], where M = Cu(II), Zn(II), Co(II) and Ni(II), X = phthalic acid and L = Schiff base generated from benzene-1,2,diamine and 4-chlorobenzaldehyde, were synthesized and characterized by IR, UV-Vis, 1H NMR, 13C NMR and mass spectra. According to the physico-chemical studies, all the synthesized metal(II) complexes have a square planar geometry. The DNA nuclease activity of the synthesized metal complexes was investigated using UV absorption assay and viscosity, validating the intercalative mechanism of binding. Antimicrobial activity of the ligand and its metal(II) complexes on various microorganisms was also investigated. The optimal form and biological accessibility of the metal complexes were examined by the Gaussian 09W algorithm. These compounds were screened for drug-like activity and pharmacokinetic studies using the free SWISS ADME online software. The positive outcomes of molecular docking studies on the COVID-19 virus and cancer DNA are interesting.

The profound significance of Subtle Anatomy in Ayurveda - A comprehensive exploration

Background: Ayurveda, the Indian system of medicine, has long highlighted the harmony of the body, mind, and spirit. Subtle anatomy deals with the perceptive of the energetic facets of the human being. Unlike gross anatomy, which deals with the structural organisation, subtle anatomy delves into the further insubstantial magnitude of subsistence. Fundamentals of subtle anatomy include Nadi (Energy channels), Prana (Life force), Chakra (Energy centres), Kosha (Sheaths) & Oja (Nectar/essence of body tissues). The subtler dimensions of the Ayurvedic anatomy remain under explored and critical to overall health. Objective: To explicate the perception of subtle anatomy in Ayurveda and delineate its role in integrative health approach. Materials and Methods: An all-inclusive appraisal and analysis was done on various concepts of subtle anatomy in Ayurveda and Yoga philosophy, including classical compendiums like Charaka Samhita and Sushruta Samhita. A review of contemporary literature along with journal articles, and online information related to the topic was also considered. Textual inputs from various other traditional approaches were also searched thoroughly and analysed. Results: The positive outcomes of various studies conducted worldwide give an essence of the benefits of an integrative approach of healing with subtle anatomical entities and contemporary medicine. Not only psychological disorders but also physical disorders like diabetic foot etc. have been recovered more efficiently via a subtle energy approach. Conclusion: Immense portrayal of subtle energies and their implication are described in Ayurveda and contemporary texts. The holistic approach of Ayurveda cannot be achieved without understanding its subtle anatomical entities with practical value. The exploration revealed the indispensable importance of subtle anatomy, providing an insight into its relations with physiological processes, psychological health, spiritual balance and overall, well-being.

Is ROTEM Diagnostic in Trauma Care Associated with Lower Mortality Rates in Bleeding Patients?-A Retrospective Analysis of 7461 Patients Derived from the TraumaRegister DGU®.

Introduction: Death from uncontrolled trauma haemorrhage and subsequent trauma-induced coagulopathy (TIC) is potentially preventable. Point-of-care devices such as rotational thromboelastometry (ROTEM®) are advocated to detect haemostatic derangements more rapidly than conventional laboratory diagnostics. Regarding reductions in RBC transfusion, the use of ROTEM has been described as being efficient and associated with positive outcomes in several studies. Objective: The effect of ROTEM use was assessed on three different outcome variables: (i) administration of haemostatics, (ii) rate of RBC transfusions and (iii) mortality in severely injured patients. Methods and Material: A retrospective analysis of a large data set of severely injured patients collected into the TraumaRegister DGU® between 2009 and 2016 was conducted. The data of 7461 patients corresponded to the inclusion criteria and were subdivided into ROTEM-using and ROTEM-non-using groups. Both groups were analysed regarding (i) administration of haemostatics, (ii) rate of RBC transfusions and (iii) mortality. Results: A lower mortality rate in ROTEM-using groups was observed (p = 0.043). Furthermore, more patients received haemostatic medication when ROTEM was used. In ROTEM-using groups, there was a statistically relevant higher application of massive transfusion. Conclusions: In this retrospective study, the use of ROTEM was associated with reduced mortality and an increased application of haemostatics and RBC transfusions. Prospective evidence is needed for further evidence-based recommendations.

Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities

BackgroundPeople with severe psychiatric disabilities and impaired autonomy, living in sheltered or supported housing facilities, often lead sedentary, solitary lives indoors and have significantly poorer health than others in the population. Meaningful everyday activities are important for the recovery towards an enrichening, agentic, social, and hopeful everyday life. The Everyday Life Rehabilitation (ELR) model—a person-centred activity- and recovery-oriented intervention—has shown positive outcomes in feasibility studies, and thus a randomised controlled trial (RCT) is required to establish the effectiveness of ELR, along with calculations of cost-effectiveness.MethodsThe ELR-RCT is a pragmatic, two-parallel-armed cluster RCT evaluating the effect and cost-effectiveness of using ELR from two measurement points over 6 months (pre-post intervention) and in three waves over 3 years. The primary outcome is recovering quality of life (ReQoL) at 6 months, and the secondary outcome is self-perceived recovery and daily functioning (RAS-DS) at 6 months. Additionally, Goal Attainment Scaling (GAS) will be used for the intervention group. Power analysis has been conducted for primary outcome measure. The first wave will include an internal pilot, to be evaluated after 6 months, used as basis for decisions on updating the required sample size and any other need for adaptations before continuing with the full-scale RCT in the second and third wave. All municipalities within a geographic area in northern Sweden, with a minimum of one sheltered or supported housing facility for people with severe psychiatric or neuropsychiatric disability, including access to occupational therapy, will be enrolled. Participants will be block-randomised to receive ELR plus treatment as usual (TAU) or TAU alone for a control period. The control group will thereafter receive delayed ELR. Occupational therapists and housing staff will receive an educational package, manuals, and tools, as well as reflections with colleagues during the intervention period. Housing managers will receive questions for monthly follow-up and coaching with staff.DiscussionThis is a protocol for both an internal pilot and full trial of the first RCT study using the ELR intervention model in sheltered or supported housing facilities, evaluating the effects together with cost-effectiveness.Trial registrationClinicalTrials.gov NCT05056415. Registered on 24 September 2021.

Mobile-Social Learning for Continuing Professional Development in Low- and Middle-Income Countries: Integrative Review.

BackgroundAccess to continuing professional development (CPD) for health care workers in low- and middle-income countries (LMICs) is severely limited. Digital technology serves as a promising platform for supporting CPD for health care workers by providing educational content virtually and enabling virtual peer-to-peer and mentor interaction for enhanced learning. Digital strategies for CPD that foster virtual interaction can increase workforce retention and bolster the health workforce in LMICs.ObjectiveThe objective of this integrative review was to evaluate the evidence on which digital platforms were used to provide CPD to health care workers and clinical students in LMICs, which was complemented with virtual peer-to-peer or mentor interaction. We phrased this intersection of virtual learning and virtual interaction as mobile-social learning.MethodsA comprehensive database and gray literature search was conducted to identify qualitative, quantitative, and mixed methods studies, along with empirical evidence, that used digital technology to provide CPD and virtual interaction with peers or mentors. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Eligible articles were written in English, conducted in an LMIC, and used a mobile device to provide CPD and facilitate virtual peer-to-peer or mentor interaction. Titles, abstracts, and full texts were screened, followed by an assessment of the quality of evidence and an appraisal of the articles. A content analysis was then used to deductively code the data into emerging themes.ResultsA total of 750 articles were identified, and 31 (4.1%) were included in the review. SMS text messaging and mobile instant messaging were the most common methods used to provide continuing education and virtual interaction between peers and mentors (25/31, 81%). Across the included articles, participants had high acceptability for using digital platforms for learning and interaction. Virtual peer interaction and mentorship were found to contribute to positive learning outcomes in most studies (27/31, 87%) through increased knowledge sharing, knowledge gains, improved clinical skills, and improved service delivery. Peer-to-peer and mentor interaction were found to improve social support and reduce feelings of isolation (9/31, 29%). There were several challenges in the implementation and use of digital technology for mobile-social learning, including limited access to resources (eg, internet coverage and stable electricity), flexibility in scheduling to participate in CPD, and sociobehavioral challenges among students.ConclusionsThe summary suggests that mobile-social learning is a useful modality for curriculum dissemination and skill training and that the interface of mobile and social learning serves as a catalyst for improved learning outcomes coupled with increased social capital.