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Scientific Reports Feb 2021Patients infected with SARS-CoV-2 may deteriorate rapidly and therefore continuous monitoring is necessary. We conducted an observational study involving patients with...
Patients infected with SARS-CoV-2 may deteriorate rapidly and therefore continuous monitoring is necessary. We conducted an observational study involving patients with mild COVID-19 to explore the potentials of wearable biosensors and machine learning-based analysis of physiology parameters to detect clinical deterioration. Thirty-four patients (median age: 32 years; male: 52.9%) with mild COVID-19 from Queen Mary Hospital were recruited. The mean National Early Warning Score 2 (NEWS2) were 0.59 ± 0.7. 1231 manual measurement of physiology parameters were performed during hospital stay (median 15 days). Physiology parameters obtained from wearable biosensors correlated well with manual measurement including pulse rate (r = 0.96, p < 0.0001) and oxygen saturation (r = 0.87, p < 0.0001). A machine learning-derived index reflecting overall health status, Biovitals Index (BI), was generated by autonomous analysis of physiology parameters, symptoms, and other medical data. Daily BI was linearly associated with respiratory tract viral load (p < 0.0001) and NEWS2 (r = 0.75, p < 0.001). BI was superior to NEWS2 in predicting clinical worsening events (sensitivity 94.1% and specificity 88.9%) and prolonged hospitalization (sensitivity 66.7% and specificity 72.7%). Wearable biosensors coupled with machine learning-derived health index allowed automated detection of clinical deterioration.
Topics: Adult; Biosensing Techniques; COVID-19; Female; Humans; Machine Learning; Male; Middle Aged; Observational Studies as Topic; Wearable Electronic Devices; Young Adult
PubMed: 33623096
DOI: 10.1038/s41598-021-82771-7 -
PLoS Medicine Aug 2014The PLOS Medicine Editors endorse four measures to ensure transparency in the analysis and reporting of observational studies. Please see later in the article for the...
The PLOS Medicine Editors endorse four measures to ensure transparency in the analysis and reporting of observational studies. Please see later in the article for the Editors' Summary.
Topics: Editorial Policies; Guidelines as Topic; Observational Studies as Topic; Periodicals as Topic
PubMed: 25158064
DOI: 10.1371/journal.pmed.1001711 -
BMJ Open Aug 2023This study's overarching goal is to examine the relationship between brain circuits and suicidal thoughts and behaviours (STBs) in a transdiagnostic sample of US... (Observational Study)
Observational Study
INTRODUCTION
This study's overarching goal is to examine the relationship between brain circuits and suicidal thoughts and behaviours (STBs) in a transdiagnostic sample of US military veterans. Because STBs have been linked with maladaptive decision-making and disorders linked to impulsivity, this investigation focuses on valence and inhibitory control circuits.
METHODS AND ANALYSIS
In this prospective, observational study, we will collect functional MRI (fMRI), cognitive and clinical data from 136 veterans (target sample size) recruited from the Providence VA Health System (PVAHS): 68 with STBs and 68 matched controls. Behavioural data will be collected using standardised measures of STBs, psychiatric symptoms, cognition, functioning and medical history. Neuroimaging data will include structural, task and resting fMRI. We will conduct follow-up interviews and assessments at 6, 12 and 24 months post-enrolment. Primary analyses will compare data from veterans with and without STBs and will also evaluate whether activation and connectivity within circuits of valence and inhibition covary with historical and prospective patterns of suicidal ideation and behaviour.
ETHICS AND DISSEMINATION
The PVAHS Institutional Review Board approved this study (2018-051). Written informed consent will be obtained from all participants. Findings from this study will be published in peer-reviewed journals and presented at local, regional, national and international conferences.Nauder Namaky, Ph.D.* [email protected].
Topics: Humans; Impulsive Behavior; Neuroimaging; Observational Studies as Topic; Prospective Studies; Suicidal Ideation; Veterans
PubMed: 37586858
DOI: 10.1136/bmjopen-2022-070654 -
BMJ Open Nov 2022The intestinal microbiome in early life plays a major role in infant health and development. Factors like antibiotic exposure, breast/formula feeding and mode of...
INTRODUCTION
The intestinal microbiome in early life plays a major role in infant health and development. Factors like antibiotic exposure, breast/formula feeding and mode of delivery are known to affect the microbiome. The increasing occurrence of caesarean section (C-section) deliveries and antibiotic exposure warrants further insight into the potential missing microbes in those infants. The study objective is to study the effect of maternal antibiotic administration during pregnancy and/or C-section mode of delivery on the development of the infant's intestinal microbiome until the age of 2 years.
METHODS AND ANALYSIS
A single site, cross-sectional observational study of C-section and vaginally delivered infants being either exposed to maternal antibiotic treatment or not during the third trimester of pregnancy. Throughout the nine visits, stool, urine, saliva, hair, breast milk and vaginal swabs will be collected from either mother and/or infant for microbiome and metabolomic analysis.
ETHICS AND DISSEMINATION
The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The trial has been registered at ClinicalTrials.gov.The findings from this study will be disseminated in peer-reviewed journals, during scientific conferences, and directly to the study participants. Sequencing data will be deposited in public databases.
TRIAL REGISTRATION NUMBER
NCT04134819.
Topics: Infant; Humans; Pregnancy; Female; Child, Preschool; Cesarean Section; Anti-Bacterial Agents; Cross-Sectional Studies; Gastrointestinal Microbiome; Feces; Observational Studies as Topic
PubMed: 36323464
DOI: 10.1136/bmjopen-2022-064398 -
Journal of General Internal Medicine Apr 2014Most people with a chronic disease actually have more than one, a condition known as multimorbidity. Despite this, the evidence base to prevent adverse disease outcomes... (Review)
Review
Most people with a chronic disease actually have more than one, a condition known as multimorbidity. Despite this, the evidence base to prevent adverse disease outcomes has taken a disease-specific approach. Drawing on a conference, Improving Guidelines for Multimorbid Patients, the goal of this paper is to identify challenges to the generation of evidence to support the care of people with multimorbidity and to make recommendations for improvement. We identified three broad categories of challenges: 1) challenges to defining and measuring multimorbidity; 2) challenges related to the effects of multimorbidity on study design, implementation and analysis; and 3) challenges inherent in studying heterogeneity of treatment effects in patients with differing comorbid conditions. We propose a set of recommendations for consideration by investigators and others (reviewers, editors, funding agencies, policymaking organizations) involved in the creation of evidence for this common type of person that address each of these challenges. The recommendations reflect a general approach that emphasizes broader inclusion (recruitment and retention) of patients with multimorbidity, coupled with more rigorous efforts to measure comorbidity and comorbidity burden and the influence of multimorbidity on outcomes and the effects of therapy. More rigorous examination of heterogeneity of treatment effects requires careful attention to prioritizing the most important comorbid-related questions, and also requires studies that provide greater statistical power than conventional trials have provided. Relatively modest changes in the orientation of current research along these lines can be helpful in pointing to and partially addressing selected knowledge gaps. However, producing a robust evidence base to support patient-centered decision making in complex individuals with multimorbidity, exposed to many different combinations of potentially interacting factors that can modify the risks and benefits of therapies, is likely to require a clinical research enterprise fundamentally restructured to be more fully integrated with routine clinical practice.
Topics: Comorbidity; Congresses as Topic; Evidence-Based Medicine; Humans; Observational Studies as Topic; Practice Guidelines as Topic; Randomized Controlled Trials as Topic
PubMed: 24442333
DOI: 10.1007/s11606-013-2660-5 -
BMJ Open Mar 2019Hypertension is a common chronic health condition. Having health insurance reduces hypertension risk; health insurance coverage could improve hypertension screening,...
INTRODUCTION
Hypertension is a common chronic health condition. Having health insurance reduces hypertension risk; health insurance coverage could improve hypertension screening, treatment and management. The Medicaid eligibility expansion of the Affordable Care Act was ruled not to be required by the US Supreme Court. Subsequently, a 'natural experiment' was produced with some states expanding Medicaid eligibility while others did not. This presents a unique opportunity to learn whether and to what extent Medicaid expansion can affect healthcare access and services for patients at risk for and diagnosed with hypertension, and patients with undiagnosed hypertension. Additionally, social determinants of health (SDH), at both the individual- and community-level, influence diagnosis and care for hypertension and it is important to understand how they interact with health insurance coverage changes.
METHODS/DESIGN
We will use electronic health record (EHR) data from Accelerating Data Value Across a National Community Health Center Network clinical data research network, which has data from community health centres in 22 states, some that did and some that did not expand Medicaid. Data include information on changes in health insurance, service receipt and health outcomes from 2012 through the most recent data available. We will include patients between the ages of 19 and 64 years (n=1 524 241) with ≥1 ambulatory visit to a community health centre. We will estimate differences in outcomes using difference-in-difference and difference-in-difference-in-difference approaches. We will test three-way interactions with insurance group, time and social determinants of health factors to compare the potential effect of gaining insurance on our proposed outcomes.
ETHICS AND DISSEMINATION
This study uses secondary data analysis and therefore approval for consent to participate was waived. The Institutional Review Board for OHSU approved this study. Approval reference number is: IRB00011858. We plan to disseminate our findings at relevant conferences, meetings and through peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT03545763.
Topics: Adult; Community Health Centers; Electronic Health Records; Female; Humans; Hypertension; Male; Medicaid; Middle Aged; Multicenter Studies as Topic; Observational Studies as Topic; Patient Protection and Affordable Care Act; Social Determinants of Health; United States; Young Adult
PubMed: 30878987
DOI: 10.1136/bmjopen-2018-025975 -
Medicine Jun 2020To investigate the gene rearrangement and mutation of lymphoma biomarkers including (Immunoglobulin H (IgH), Immunoglobulin kappa (IGK), Immunoglobulin lambda (IGL), and...
INTRODUCTION
To investigate the gene rearrangement and mutation of lymphoma biomarkers including (Immunoglobulin H (IgH), Immunoglobulin kappa (IGK), Immunoglobulin lambda (IGL), and TCR) in the lymphoma diagnosis.
METHODS AND ANALYSIS
Paraffin tissue samples from 240 cases diagnosed as suspected lymphoma in the department of pathology, Deyang City People's Hospital from June 2020 to June 2021 will be enrolled. Deoxyribonucleic acid extraction and Polymerase Chain Reaction (PCR) amplification will be performed in these paraffin tissue samples. Immunoglobulin and T cell receptor (TCR) rearrangement will be analyzed by hetero-double chain gel electrophoresis and BioMed-2 standardized immunoglobulin gene rearrangement detection system. In this study protocol IGH gene rearrangement, IGK gene rearrangement, both IGH and IGL gene rearrangement, both IGH and IGK gene rearrangement, both IGK and IGL gene rearrangement, both IGH, IGK and IGL gene rearrangement, TCR gene rearrangement and positive Ig/TCR rearrangement will be analyzed.
DISCUSSION
In this study, we will use B and T cell lymphoma analysis focusing on IgH, IGK, IGL, and TCR gene rearrangement, so as to provide early guidance for the diagnosis of lymphoma. Second generation sequencing technology is helpful in the differential diagnosis of lymphoma.
TRIAL REGISTRATION
Chinese Clinical trial registry: ChiCTR2000032366.
Topics: Gene Rearrangement; Humans; Lymphoma; Mutation; Observational Studies as Topic; Prospective Studies; Research Design
PubMed: 32541525
DOI: 10.1097/MD.0000000000020733 -
The Journal of Thoracic and... Feb 2022
Topics: Humans; Observational Studies as Topic; Randomized Controlled Trials as Topic; Reproducibility of Results; Research Design; Thoracic Surgery
PubMed: 33277031
DOI: 10.1016/j.jtcvs.2020.10.120 -
Actas Dermo-sifiliograficas Apr 2021Prurigo nodularis is a chronic inflammatory skin disease characterized by highly pruritic nodular lesions that cause constant itching and scratching and significant... (Review)
Review
BACKGROUND AND OBJECTIVE
Prurigo nodularis is a chronic inflammatory skin disease characterized by highly pruritic nodular lesions that cause constant itching and scratching and significant quality-of-life impairment. It has been described in a range of conditions, including skin diseases (mainly atopic dermatitis) and metabolic, neurological, and psychiatric disorders. The pathophysiological mechanisms are largely unknown. Various modalities of phototherapy have been described as appropriate and safe treatments for achieving clinical control and alleviating symptoms. In this article, we describe our experience with phototherapy in patients with prurigo nodularis.
MATERIAL AND METHODS
Retrospective observational study of patients who received their first cycle of phototherapy to treat prurigo nodularis between March 2011 and October 2019. Information was collected on epidemiological and clinical characteristics, concomitant treatments, type and duration of phototherapy, maximum dose reached, and response to treatment.
RESULTS
We studied 44 patients (30 women and 14 men) with a median age of 65.5years. The most common form of phototherapy used was narrowband UV-B phototherapy (34 cycles, 77.27%) followed by a combination of UV-B and UV-A phototherapy (8 cycles). Response to treatment was considered satisfactory (clearance rate of ≥75%) in 24 patients (55.4%).
CONCLUSIONS
Phototherapy is a suitable treatment for prurigo nodularis in a considerable proportion of patients. It can be used as monotherapy or combined with other treatments.
Topics: Aged; Female; Humans; Male; Observational Studies as Topic; Phototherapy; Prurigo; Pruritus; Skin; Ultraviolet Therapy
PubMed: 33221272
DOI: 10.1016/j.ad.2020.11.007 -
BMJ Open Aug 2023Digital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of...
INTRODUCTION AND AIMS
Digital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of interventions. Motor function, physiology and behaviour can provide informative measures of neurological conditions and neurodegenerative decline. New digital technologies present an opportunity to provide remote, high-frequency monitoring of patients from within their homes. The purpose of the living lab study is to develop novel digital biomarkers of functional impairment in those living with neurodegenerative disease (NDD) and neurological conditions.
METHODS AND ANALYSIS
The Living Lab study is a cross-sectional observational study of cognition and behaviour in people living with NDDs and other, non-degenerative neurological conditions. Patients (n≥25 for each patient group) with dementia, Parkinson's disease, amyotrophic lateral sclerosis, mild cognitive impairment, traumatic brain injury and stroke along with controls (n≥60) will be pragmatically recruited. Patients will carry out activities of daily living and functional assessments within the Living Lab. The Living Lab is an apartment-laboratory containing a functional kitchen, bathroom, bed and living area to provide a controlled environment to develop novel digital biomarkers. The Living Lab provides an important intermediary stage between the conventional laboratory and the home. Multiple passive environmental sensors, internet-enabled medical devices, wearables and electroencephalography (EEG) will be used to characterise functional impairments of NDDs and non-NDD conditions. We will also relate these digital technology measures to clinical and cognitive outcomes.
ETHICS AND DISSEMINATION
Ethical approvals have been granted by the Imperial College Research Ethics Committee (reference number: 21IC6992). Results from the study will be disseminated at conferences and within peer-reviewed journals.
Topics: Humans; Cross-Sectional Studies; Activities of Daily Living; Neurodegenerative Diseases; Cognitive Dysfunction; Cognition; Biomarkers; Observational Studies as Topic
PubMed: 37536971
DOI: 10.1136/bmjopen-2023-072094