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PloS One 2024Auditory-verbal hallucinatory experiences (AVH) have a 12% prevalence in the general pediatric population. Literature reports a higher risk of developing AVH in... (Observational Study)
Observational Study
Relationship between social cognition and emotional markers and acoustic-verbal hallucination in youth with post-traumatic stress disorder: Protocol for a prospective, 2-year, longitudinal case-control study.
INTRODUCTION
Auditory-verbal hallucinatory experiences (AVH) have a 12% prevalence in the general pediatric population. Literature reports a higher risk of developing AVH in post-traumatic stress disorder (PTSD). The persistence of AVHs during adolescence represents a risk of evolution into psychotic disorders. Social cognition and emotional markers could be considered prodromes markers of this evolution. The objectives of this prospective observational study are to observe social cognition and emotional markers correlation with the presence and persistence of AVH over two years and with the evolution of PTSD and psychotic diagnosis.
METHODS AND ANALYSIS
This prospective case-control study, longitudinal over two years (with an interim reassessment at six months and one year), will include 40 participants aged 8 to 16 years old with a diagnosis of PTSD and without a diagnosis of psychosis according to the criteria of DSM-5 (K-SADS-PL). Subjects included are divided into two groups with AVH and without AVH matched by gender, age and diagnosis. The primary outcome measure will be the correlation between social cognition and emotional makers and the presence of AVH in the PTSD pediatric population without psychotic disorders. The social cognition marker is assessed with the NEPSY II test. The emotional marker is assessed with the Differential Emotion Scale IV and the Revised Beliefs About Voices Questionnaire. The secondary outcome measures are the correlation of these markers with the persistence of AVH and the evolution of the patient's initial diagnosis two years later.
DISCUSSION
The originality of our protocol is to explore the potential progression to psychosis from PTSD by cognitive biases. This study supports the hypothesis of connections between PTSD and AVH through sensory, emotional and cognitive biases. It proposes a continuum model from PTSD to psychotic disorder due to impaired perception like AVH.
TRIAL REGISTRATION
Clinical trial registration: ClinicalTrials.gov Identifier: NCT03356028.
Topics: Humans; Stress Disorders, Post-Traumatic; Adolescent; Child; Case-Control Studies; Male; Female; Prospective Studies; Longitudinal Studies; Emotions; Hallucinations; Social Cognition; Psychotic Disorders
PubMed: 38954699
DOI: 10.1371/journal.pone.0306338 -
PloS One 2024This research protocol presents an action research project with the aim to demonstrate the value of person-centred fundamental care to nurses and nurse managers in...
InCHARGE: Co-creating, implementing and evaluating interventions to utilize nurses' competence and achieve person-centred fundamental care-A research protocol describing an action research approach.
AIM AND OBJECTIVES
This research protocol presents an action research project with the aim to demonstrate the value of person-centred fundamental care to nurses and nurse managers in surgical care units to encourage a far-reaching change in this direction. The objectives are to describe this process and to evaluate the effects on missed nursing care and person-centred fundamental care.
METHODS
In a novel collaboration between nursing science and medical humanities the action research design will be used to interact with nursing staff and leaders in three surgical care units and design interventions with the purpose to affect the direction of nursing. Initially, the care units will be presented with interactive workshops including evidence-based education on person-centered fundamental care, person-centredness, nurse role responsibility and leadership. This will be followed by cocreation of interventions to stimulate person-centered fundamental care. The Fundamentals of Care framework will be used as the overarching theoretical framework. Data on missed nursing care, person-centred climate and person-centered fundamental care will be collected repeatedly from patient- and nursing stakeholders through interviews and validated questionnaires. Additionally, data from written reflections following clinical observations and focus group interviews will be included. The duration of the study will be approximately five years from ethical approval.
DISCUSSION
It has been previously reported that the current working environments of registered nurses are forcing them to ration their caring responsibilities, leading to a lack of fulfillment of patients' fundamental care needs, with possible severe consequences for patients. The action research design helps researchers gain an understanding of the contextual factors important for forthcoming interventions, enabling reflective processes and cocreation of interventions with stakeholders. This may lead to feasible interventions and strengthen nursing leadership in the involved units.
Topics: Humans; Patient-Centered Care; Health Services Research; Clinical Competence; Leadership; Nurses; Surveys and Questionnaires; Research Design
PubMed: 38954688
DOI: 10.1371/journal.pone.0304700 -
PloS One 2024Therapeutic connections (TC) between patients and providers are foundational to patient-centered care, which is co-produced between patients and care providers. This... (Observational Study)
Observational Study
Therapeutic connections (TC) between patients and providers are foundational to patient-centered care, which is co-produced between patients and care providers. This necessitates that we understand what patients expect from TCs, the extent to which providers know what patients expect, and what providers expect. The purpose of this study was to examine nine TC dimensions and determine which are most important to patients, which dimensions providers believe are most important to patients, and which are most important to providers. An online survey of patients (n = 388) and care providers (n = 433) was conducted in the USA in March 2021. Respondents rated the extent to which the nine TC dimensions were important to them, followed by open-ended questions to expand upon what matters. The quantitative responses were rank-ordered and rankings were compared across groups. All groups ranked "having the patient's best interest in mind no matter what" as the top expectation. Patients also ranked "caring commitment" and being "on the same page" as highly important. Providers were relatively accurate in ranking what they believed was most important to patients. Respondents affirmed the TC dimensions in the qualitative results, adding nuance and context, such as patients feeling "heard" and noting providers that go "above and beyond." Providers ranked dimensions differently for themselves, prioritizing "full presence" and "emotional support" of patients. This study is among the first to examine expectations for TC. TC could play an explanatory role in understanding variation in patient experience ratings and other outcomes.
Topics: Humans; Male; Female; Adult; Middle Aged; Patient-Centered Care; Surveys and Questionnaires; Health Personnel; Physician-Patient Relations; Aged; Young Adult; Adolescent
PubMed: 38954686
DOI: 10.1371/journal.pone.0304854 -
PloS One 2024Autoimmune diseases affect 5-10% of the global population and cause chronic pain and impaired functionality. Chronic pain management involves pharmacological and...
BACKGROUND
Autoimmune diseases affect 5-10% of the global population and cause chronic pain and impaired functionality. Chronic pain management involves pharmacological and non-pharmacological interventions, with non-pharmacological options gaining attention as safe, effective, and cost-effective alternatives. However, further research is needed to determine the effectiveness of these therapies in African patients with autoimmune diseases, as existing evidence varies.
METHODS
This review protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO, CRD42023449896). Electronic databases (PubMed, Africa Index Medicus, Cochrane Library, CINAHL, PsycINFO, and Web of Science) will be used for searching published articles. The study will use R for data synthesis, employing a random-effects meta-analysis approach to calculate pooled effect sizes, assess heterogeneity using the I2 statistic, and evaluate publication bias. In conclusion, this protocol aims to fill the knowledge gap on non-pharmacological therapies for chronic pain in patients with autoimmune diseases in Africa. It will potentially enhance evidence-based decision-making to improve pain management and, hence, the quality of life of people with autoimmune diseases in Africa.
Topics: Humans; Systematic Reviews as Topic; Chronic Pain; Autoimmune Diseases; Meta-Analysis as Topic; Africa; Pain Management; Quality of Life
PubMed: 38954682
DOI: 10.1371/journal.pone.0306564 -
PloS One 2024Uterine leiomyomas (often referred to as fibroids or myomas) are common benign, hormone-dependent tumors that grow in the uterus and occur in approximately 25% of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Uterine leiomyomas (often referred to as fibroids or myomas) are common benign, hormone-dependent tumors that grow in the uterus and occur in approximately 25% of reproductive age women, depending on selected population. Treatment recommendation is typically based on fibroid size, location, the patient's age, reproductive plans, and obstetrical history. Despite the range of treatment options available for uterine fibroids and their symptoms, including hysterectomy, myomectomy, endometrial ablation, endometrial uterine artery embolization, and magnetic resonance-guided focused-ultrasound surgery, myomectomy remains the gold standard treatment for patients who desire fertility-preserving surgery for their uterine fibroids. Myomectomy, while a prevalent surgical option for the removal of fibroids, carries known risks such as fibroid recurrence, symptom recurrence, and the subsequent need for reintervention. Despite ongoing research and advances in medical treatments for fibroids, there currently are no universally recommended therapeutic interventions proven to effectively delay the recurrence of fibroids or the return of symptoms following this procedure. This situation underscores a significant area of unmet medical need and highlights the importance of continued investigation into preventive strategies and long-term management options for patients undergoing fibroid removal with uterine preservation. We designed a study to assess the efficacy of the new FDA-approved GnRH antagonist, Myfembree in delaying the return of fibroids and their associated symptoms.
METHODS
A randomized, prospective, open-label clinical trial. The participants (n = 136) will be randomly distributed into two groups. The Control Group (Standard of care) will receive treatment with standard of care (SoC) after surgical myomectomy and the treatment group will receive Relugolix combination therapy (Myfembree®) after surgical myomectomy. The study protocol was approved by the University of Chicago's Institutional Review Board (IRB#22-0282), ensuring that all participants would provide written informed consent before their inclusion.
DISCUSSION
In this project, we propose the use of daily dosed Relugolix combination therapy (Relugolix with estradiol and norethindrone acetate), which is approved for uterine fibroids treatment, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay need for re-intervention after uterine sparing surgery.
TRIAL REGISTRATION
The study protocol was approved by the Institutional Review Board of the University of Chicago on 9/16/2022 and was registered at ClinicalTrials.gov with number NCT05538689 on Sep 7, 2022. All subjects will provide informed consent to participate.
Topics: Humans; Female; Uterine Myomectomy; Leiomyoma; Standard of Care; Uterine Neoplasms; Adult; Middle Aged; Randomized Controlled Trials as Topic; Quality of Life
PubMed: 38954680
DOI: 10.1371/journal.pone.0306053 -
PloS One 2024Sedatives are commonly used to promote sleep in intensive care unit patients. However, it is not clear whether sedation-induced states are similar to the biological...
Do all sedatives promote biological sleep electroencephalogram patterns? A machine learning framework to identify biological sleep promoting sedatives using electroencephalogram.
BACKGROUND
Sedatives are commonly used to promote sleep in intensive care unit patients. However, it is not clear whether sedation-induced states are similar to the biological sleep. We explored if sedative-induced states resemble biological sleep using multichannel electroencephalogram (EEG) recordings.
METHODS
Multichannel EEG datasets from two different sources were used in this study: (1) sedation dataset consisting of 102 healthy volunteers receiving propofol (N = 36), sevoflurane (N = 36), or dexmedetomidine (N = 30), and (2) publicly available sleep EEG dataset (N = 994). Forty-four quantitative time, frequency and entropy features were extracted from EEG recordings and were used to train the machine learning algorithms on sleep dataset to predict sleep stages in the sedation dataset. The predicted sleep states were then compared with the Modified Observer's Assessment of Alertness/ Sedation (MOAA/S) scores.
RESULTS
The performance of the model was poor (AUC = 0.55-0.58) in differentiating sleep stages during propofol and sevoflurane sedation. In the case of dexmedetomidine, the AUC of the model increased in a sedation-dependent manner with NREM stages 2 and 3 highly correlating with deep sedation state reaching an AUC of 0.80.
CONCLUSIONS
We addressed an important clinical question to identify biological sleep promoting sedatives using EEG signals. We demonstrate that propofol and sevoflurane do not promote EEG patterns resembling natural sleep while dexmedetomidine promotes states resembling NREM stages 2 and 3 sleep, based on current sleep staging standards.
Topics: Humans; Electroencephalography; Machine Learning; Hypnotics and Sedatives; Male; Adult; Female; Sleep; Propofol; Sevoflurane; Dexmedetomidine; Sleep Stages; Young Adult
PubMed: 38954679
DOI: 10.1371/journal.pone.0304413 -
PloS One 2024The World Health Organization (WHO) called for the expansion of all nursing roles, including advanced practice nurses (APNs), nurse practitioners (NPs) and clinical... (Review)
Review
INTRODUCTION
The World Health Organization (WHO) called for the expansion of all nursing roles, including advanced practice nurses (APNs), nurse practitioners (NPs) and clinical nurse specialists (CNSs). A clearer understanding of the impact of these roles will inform global priorities for advanced practice nursing education, research, and policy.
OBJECTIVE
To identify gaps in advanced practice nursing research globally.
MATERIALS AND METHODS
A review of systematic reviews was conducted. We searched CINAHL, Embase, Global Health, Healthstar, PubMed, Medline, Cochrane Library, DARE, Joanna Briggs Institute EBP, and Web of Science from January 2011 onwards, with no restrictions on jurisdiction or language. Grey literature and hand searches of reference lists were undertaken. Review quality was assessed using the Critical Appraisal Skills Program (CASP). Study selection, data extraction and CASP assessments were done independently by two reviewers. We extracted study characteristics, country and outcome data. Data were summarized using narrative synthesis.
RESULTS
We screened 5840 articles and retained 117 systematic reviews, representing 38 countries. Most CASP criteria were met. However, study selection by two reviewers was done inconsistently and language and geographical restrictions were applied. We found highly consistent evidence that APN, NP and CNS care was equal or superior to the comparator (e.g., physicians) for 29 indicator categories across a wide range of clinical settings, patient populations and acuity levels. Mixed findings were noted for quality of life, consultations, costs, emergency room visits, and health care service delivery where some studies favoured the control groups. No indicator consistently favoured the control group. There is emerging research related to Artificial Intelligence (AI).
CONCLUSION
There is a large body of advanced practice nursing research globally, but several WHO regions are underrepresented. Identified research gaps include AI, interprofessional team functioning, workload, and patients and families as partners in healthcare.
PROSPERO REGISTRATION NUMBER
CRD42021278532.
Topics: Humans; Advanced Practice Nursing; Nursing Research; Global Health
PubMed: 38954675
DOI: 10.1371/journal.pone.0305008 -
PloS One 2024Patients experience emotional distress and hold cardiac misconceptions following ST-elevation myocardial infarction. These issues informed the co-production of Cardiac... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Patients experience emotional distress and hold cardiac misconceptions following ST-elevation myocardial infarction. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. The current study will establish a knowledge base for the feasibility of delivering this intervention to patients following ST-elevation myocardial infarction, with a preliminary exploration of impact on associated outcomes (ClinicalTrials.gov: NCT05848674).
METHODS
A pilot randomised controlled trial incorporating a mixed-methods design will be conducted. Patients with ST-elevation myocardial infarction (number = 40) will be recruited from coronary care units at two hospital centres in Northern Ireland, with participants randomised (1:1) to the intervention or control group. Cardiac Brief Intervention constitutes a nurse-led, short (20 minutes) emotional and educational support discussion with a patient, with a leaflet that serves as a memory-aid. It will be delivered to the intervention group prior to discharge from a coronary care unit. The control group will receive standard care information. Data will be collected at baseline, post-intervention, 4 weeks from diagnosis, and 14 weeks from diagnosis. Feasibility measurements and process evaluation (quantitative and qualitative) will assess the viability of the research design and intervention delivery. Cardiac rehabilitation attendance data will be collected, and participants will complete questionnaires related to associated outcomes. Quantitative data will be reported with descriptive statistics and qualitative data will be analysed using framework analysis, with data integrated to achieve triangulation of findings.
DISCUSSION
Educational and emotional difficulties following ST-elevation myocardial infarction may impede patient outcomes and cardiac rehabilitation participation. These issues informed the co-production of Cardiac Brief Intervention with patients and clinicians. This study will evaluate the feasibility of delivering Cardiac Brief Intervention to patients. These results will inform large-scale definitive testing of the intervention, which may lead to adoption in clinical practice to improve cardiac rehabilitation uptake and patient outcomes.
Topics: Humans; Pilot Projects; ST Elevation Myocardial Infarction; Feasibility Studies; Male; Female; Middle Aged; Northern Ireland
PubMed: 38954674
DOI: 10.1371/journal.pone.0306406 -
European Thyroid Journal Jul 2024The aim of this study was to assess the clinical impact of hand-foot syndrome (HFS) during treatment with two multikinase inhibitors, sorafenib and lenvatinib, in a...
OBJECTIVE
The aim of this study was to assess the clinical impact of hand-foot syndrome (HFS) during treatment with two multikinase inhibitors, sorafenib and lenvatinib, in a large group of patients with advanced thyroid cancer. Moreover, we looked for possible associations between HFS occurrence and clinical and pathological features.
METHODS
We retrospectively evaluated 239 patients with advanced thyroid cancer: 165 treated with lenvatinib and 74 with sorafenib. Statistical analysis was performed to verify which features could be correlated with HFS development.
RESULTS
HFS was observed in 35/74 (47.4%) and in 43/165 (26.7%) patients treated with sorafenib or lenvatinib, respectively. The median latency from the drug beginning and HFS appearance was 27 days for sorafenib and 2.9 months for lenvatinib. G3/G4 toxicity was observed in 16/35 (45.7%) patients treated with sorafenib and only in 3/43 (7%) treated with lenvatinib. Drug dose reduction due to HFS was required in 19/74 (25.7%) and 3/165 (1.8%) patients treated with sorafenib and lenvatinib, respectively. HFS occurrence was significantly associated with a longer duration of therapy in both groups.
CONCLUSIONS
HFS was a frequent adverse event during both lenvatinib and sorafenib therapy, with a higher frequency and toxicity grade during sorafenib treatment. HFS was the most frequent reason for drug reduction or discontinuation in patient treated with sorafenib. Early diagnosis of HFS is important to allow early intervention, possibly in a multidisciplinary setting, and to avoid treatment discontinuation, which is highly relevant to obtain the maximum effectiveness of systemic therapy.
PubMed: 38954633
DOI: 10.1530/ETJ-24-0009 -
The Journal of Clinical Investigation Jul 2024Cytomegalovirus (CMV) is one of the most common and relevant opportunistic pathogens in immunocompromised individuals such as kidney transplant recipients (KTRs). The...
Cytomegalovirus (CMV) is one of the most common and relevant opportunistic pathogens in immunocompromised individuals such as kidney transplant recipients (KTRs). The exact mechanisms underlying the disability of cytotoxic T cells to provide sufficient protection against CMV in immunosuppressed individuals have not been identified yet. Here, we performed in-depth metabolic profiling of CMV-specific CD8+ T cells in immunocompromised patients and show the development of metabolic dysregulation at the transcriptional, protein, and functional level of CMV-specific CD8+ T cells in KTRs with non-controlled CMV infection. These dysregulations comprise impaired glycolysis and increased mitochondrial stress, which is associated with an intensified expression of the nicotinamide adenine dinucleotide nucleotidase (NADase) CD38. Inhibiting NADase activity of CD38 reinvigorated the metabolism and improved cytokine production of CMV-specific CD8+ T cells. These findings were corroborated in a mouse model of CMV infection under conditions of immunosuppression. Thus, dysregulated metabolic states of CD8+ T cells could be targeted by inhibiting CD38 to reverse hypo-responsiveness in individuals who fail to control chronic viral infection.
PubMed: 38954588
DOI: 10.1172/JCI179561