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BMJ Open Sep 2023Very preterm infants are at risk of abnormal microbiome colonisation in the first weeks to months of life. Several important associated factors have been identified...
INTRODUCTION
Very preterm infants are at risk of abnormal microbiome colonisation in the first weeks to months of life. Several important associated factors have been identified including gestational age, mode of delivery, antibiotic exposure and feeding. Preterm infants are at risk of a number of pathologies for which the microbiome may play a central role, including necrotising enterocolitis and sepsis. The objective of this study is to determine detailed microbiome changes that occur around implementation of different management practices including empiric antibiotic use, advancement of feeds and administration of probiotics during admission to the neonatal intensive care unit.
METHODS AND ANALYSIS
A single-site, longitudinal observational study of infants born less than 32 weeks gestation, including collection of maternal samples around delivery and breastmilk and infant samples from admission through discharge from the neonatal unit.
ETHICS AND DISSEMINATION
The protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.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
NCT05803577.
Topics: Humans; Infant, Newborn; Anti-Bacterial Agents; Gestational Age; Infant, Premature; Infant, Very Low Birth Weight; Microbiota; Observational Studies as Topic
PubMed: 37748849
DOI: 10.1136/bmjopen-2023-075060 -
BMJ Open Apr 2024Surgical patients over 70 experience postoperative delirium (POD) complications in up to 50% of procedures. Sleep/circadian disruption has emerged as a potential risk...
INTRODUCTION
Surgical patients over 70 experience postoperative delirium (POD) complications in up to 50% of procedures. Sleep/circadian disruption has emerged as a potential risk factor for POD in epidemiological studies. This protocol presents a single-site, prospective observational study designed to examine the relationship between sleep/circadian regulation and POD and how this association could be moderated or mediated by Alzheimer's disease (AD) pathology and genetic risk for AD.
METHODS AND ANALYSIS
Study staff members will screen for eligible patients (age ≥70) seeking joint replacement or spinal surgery at Massachusetts General Hospital (MGH). At the inclusion visit, patients will be asked a series of questionnaires related to sleep and cognition, conduct a four-lead ECG recording and be fitted for an actigraphy watch to wear for 7 days before surgery. Blood samples will be collected preoperatively and postoperatively and will be used to gather information about AD variant genes (-ε4) and AD-related pathology (total and phosphorylated tau). Confusion Assessment Method-Scale and Montreal Cognitive Assessment will be completed twice daily for 3 days after surgery. Seven-day actigraphy assessments and Patient-Reported Outcomes Measurement Information System questionnaires will be performed 1, 3 and 12 months after surgery. Relevant patient clinical data will be monitored and recorded throughout the study.
ETHICS AND DISSEMINATION
This study is approved by the IRB at MGH, Boston, and it is registered with the US National Institutes of Health on ClinicalTrials.gov (NCT06052397). Plans for dissemination include conference presentations at a variety of scientific institutions. Results from this study are intended to be published in peer-reviewed journals. Relevant updates will be made available on ClinicalTrials.gov.
TRIAL REGISTRATION NUMBER
NCT06052397.
Topics: Humans; Emergence Delirium; Prospective Studies; Delirium; Postoperative Complications; Cohort Studies; Sleep; Biomarkers; Observational Studies as Topic
PubMed: 38643014
DOI: 10.1136/bmjopen-2023-080796 -
BMC Psychiatry Sep 2023Perinatal depression (PND) is a significant contributor to maternal morbidity globally. Recognized as a major cause of poor infant development, epidemiological and... (Meta-Analysis)
Meta-Analysis
Perinatal depression (PND) is a significant contributor to maternal morbidity globally. Recognized as a major cause of poor infant development, epidemiological and interventional research on it has increased over the last decade. Recently, studies have pointed out that PND is a heterogeneous condition, with variability in its phenotypes, rather than a homogenous latent entity and a concrete diagnosis, as previously conceptualized in psychometric literature and diagnostic systems. Therefore, it is pertinent that researchers recognize this to progress in elucidating its aetiology and developing efficacious interventions.This systematic review is conducted in accordance with the Meta-analysis of observational studies in epidemiology (MOOSE). It aims to provide an updated and comprehensive account of research on heterogeneity in phenotypes of PND and its implications in research, public health, and clinical practice. It provides a synthesis and quality assessment of studies reporting heterogeneity in PND using cutting-edge statistical techniques and machine learning algorithms. After reporting the phenotypes of PND, based on heterogeneous trajectories and symptom profiles, it also elucidates the risk factors associated with severe forms of PND, followed by robust evidence for adverse child outcomes. Furthermore, recommendations are made to improve public health and clinical practice in screening, diagnosis, and treatment of PND.
Topics: Female; Pregnancy; Humans; Depression; Depressive Disorder; Algorithms; Machine Learning; Phenotype; Observational Studies as Topic
PubMed: 37667216
DOI: 10.1186/s12888-023-05121-z -
BMC Health Services Research Aug 2023Effective communication is a cornerstone of quality healthcare. Communication helps providers bond with patients, forming therapeutic relationships that benefit... (Review)
Review
BACKGROUND
Effective communication is a cornerstone of quality healthcare. Communication helps providers bond with patients, forming therapeutic relationships that benefit patient-centred outcomes. The information exchanged between the provider and patient can help in medical decision-making, such as better self-management. This rapid review investigated the effects of quality and effective communication on patient-centred outcomes among older patients.
METHODS
Google Scholar, PubMed, Scopus, CINAHL, and PsycINFO were searched using keywords like "effective communication," "elderly," and "well-being." Studies published between 2000 and 2023 describing or investigating communication strategies between older patients (65 years and above) and providers in various healthcare settings were considered for selection. The quality of selected studies was assessed using the GRADE Tool.
RESULTS
The search strategy yielded seven studies. Five studies were qualitative (two phenomenological study, one ethnography, and two grounded theory studies), one was a cross-sectional observational study, and one was an experimental study. The studies investigated the effects of verbal and nonverbal communication strategies between patients and providers on various patient-centred outcomes, such as patient satisfaction, quality of care, quality of life, and physical and mental health. All the studies reported that various verbal and non-verbal communication strategies positively impacted all patient-centred outcomes.
CONCLUSION
Although the selected studies supported the positive impact of effective communication with older adults on patient-centred outcomes, they had various methodological setbacks that need to be bridged in the future. Future studies should utilize experimental approaches, generalizable samples, and specific effect size estimates.
Topics: Aged; Humans; Cross-Sectional Studies; Quality of Life; Communication; Anthropology, Cultural; Clinical Decision-Making; Observational Studies as Topic
PubMed: 37608376
DOI: 10.1186/s12913-023-09869-8 -
BMC Pregnancy and Childbirth Aug 2023Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies...
MAGIC (maternal glucose in pregnancy) understanding the glycemic profile of pregnancy, intensive CGM glucose profiling and its relationship to fetal growth: an observational study protocol.
BACKGROUND
Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies of glucose metabolism in 'healthy' pregnant women a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glucose dysregulation earlier in pregnancy relates to traditional third trimester screening for gestational diabetes, fetal growth and pregnancy outcomes is lacking. This study aims to characterise longitudinal changes in glycemia across gestation using CGM, in order to understand the evolution of dysglycemia and its relationship to fetal growth.
METHOD/DESIGN
A multi-centre, prospective, observational, cohort study of 500 healthy pregnant women, recruited in the first trimester of pregnancy. Masked CGM will be performed for a 14-day period on five occasions across pregnancy at ~ 10-12, 18-20, 26-28, 34-36 weeks gestation and postnatally. Routinely collected anthropometric and sociodemographic information will be recorded at each visit including: weight, height, blood pressure, current medication. Age, parity, ethnicity, smoking will be recorded. Blood samples will be taken at each visit for HbA1c and a sample stored. Details on fetal growth from ultrasound scans and the OGTT results will be recorded. Maternal and neonatal outcomes will be collected. CGM glucose profiling is the exposure of interest, and will be performed using standard summary statistics, functional data analysis and glucotyping. The primary maternal outcome is clinical diagnosis of GDM. The primary neonatal outcome is large for gestational age (LGA) (> 90th centile defined by customised birthweight centile). The relationship of glucose to key secondary maternal and neonatal outcomes will be explored.
DISCUSSION
This study will ascertain the relationship of maternal dysglycemia to fetal growth and outcomes. It will explore whether CGM glucose profiling can detect GDM before the OGTT; or indeed whether CGM glucose profiling may be more useful than the OGTT at detecting LGA and other perinatal outcomes.
TRIAL REGISTRATION
ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 Registration date: 13th March 2023.
Topics: Female; Humans; Pregnancy; Blood Glucose; Blood Glucose Self-Monitoring; Cohort Studies; Diabetes, Gestational; Fetal Development; Glucose; Observational Studies as Topic; Pregnancy Outcome; Prospective Studies; Multicenter Studies as Topic
PubMed: 37537535
DOI: 10.1186/s12884-023-05824-x -
Frontiers in Public Health 2023The aim of this meta-analysis is to evaluate the impact of light at night (LAN) exposure on the risk of breast cancer across varying factors. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this meta-analysis is to evaluate the impact of light at night (LAN) exposure on the risk of breast cancer across varying factors.
METHOD
We conducted a systematic search of literature up to July 15, 2023, including PubMed, Cochrane Library, and Embase databases, using keywords related to breast cancer and LAN exposure. Cohort study and case-control study literature on night light exposure and breast cancer risk were included. Statistical analyses were performed using Stata software version 17.0. To address heterogeneity among different studies, we employed a random-effects model for analysis and assessed publication bias using funnel plots and Egger's test.
RESULTS
We included 13 case-control and 8 cohort studies with 734,372 participants worldwide. In the Newcastle-Ottawa Scale (NOS) assessments, the average score was 7.43 (ranging from 5 to 9). The overall meta-analysis demonstrated a significant association between exposure to LAN and risk of breast cancer (RR = 1.12; 95% CI: 1.06-1.17; I = 31.3%, < 0.001). In the subgroup analysis, the results of the analysis for study types (case-control studies: RR = 1.16; 95% CI: 1.06-1.27; I = 40.4%, = 0.001; cohort studies: RR = 1.08; 95% CI: 1.04-1.14; I = 0.0%, < 0.001) and the results for light exposure types (outdoor LAN: RR = 1.07; 95% CI: 1.02-1.13; I = 30.9%, = 0.004) are presented. In the analysis conducted for continents, the highest breast cancer risk was observed in the Asian population (Asian: RR = 1.24; 95% CI: 1.15-1.34; I = 0.0%, < 0.001) and in the analysis of estrogen receptor status (ER+: RR = 1.10; 95% CI: 1.03-1.18; I = 17.0%, = 0.005;). We also conducted an analysis on menopausal status and various lifestyles but did not find any statistically significant findings.
CONCLUSION
Our study demonstrates that LAN exposure is associated with an increased risk of breast cancer, particularly in the Asian population. Among the existing hypotheses, the idea that LAN exposure leads to a decrease in melatonin is widely accepted. However, until the mechanism of this effect is clearly elucidated, it is not recommended to take melatonin supplements for breast cancer prevention without medical advice. We hope to conduct more high-quality research, especially concerning the investigation of other environmental confounding factors, to further advance this field.
Topics: Female; Humans; Breast Neoplasms; Case-Control Studies; Cohort Studies; Melatonin; Observational Studies as Topic
PubMed: 38106885
DOI: 10.3389/fpubh.2023.1276290 -
Journal of the American Pharmacists... 2023Inpatient hypoglycemia is associated with increased morbidity and mortality. After a hypoglycemic event, the likelihood of additional episodes increases. The Joint... (Observational Study)
Observational Study
BACKGROUND
Inpatient hypoglycemia is associated with increased morbidity and mortality. After a hypoglycemic event, the likelihood of additional episodes increases. The Joint Commission recommends evaluating all episodes of hypoglycemia for root-cause analysis. Studies have shown that pharmacists' involvement with glycemic control protocols can prevent hypoglycemia.
OBJECTIVES
This study aimed to assess whether the implementation of pharmacists' real-time assessment of hypoglycemic events using an electronic alert messaging system contributes to the reduction of the number of recurrent hypoglycemia during hospitalization.
PRACTICE DESCRIPTION
A community hospital that provides a wide range of health care services. The pharmacy department provides fully decentralized clinical services and team-based specialist services.
PRACTICE INNOVATION
The pharmacist-led hypoglycemia stewardship initiative included a comprehensive review of hypoglycemic alerts received via an automated message. The alerts generated in the electronic health record (EHR) every time a patient's blood glucose resulted in less than 70 mg/dL if there was a documented administration of a hypoglycemic agent 48 hours before the hypoglycemia event. Once the alert was received by the pharmacists via an EHR in-basket, a real-time review was conducted to identify the potential causes of the event and opportunities for therapy modification.
EVALUATION METHODS
A single-center retrospective observational study including a pre- and post-implementation phase from January 1 to June 3, 2020, and January 1 to June 30, 2021, respectively. Continuous data were analyzed using paired and equal variance t test. Noncontinuous data were analyzed using Fisher exact and chi-square test. Descriptive statistics were used to describe distribution and frequency of data.
RESULTS
There was a 5.1% absolute reduction in recurrent hypoglycemic events (P < 0.001) and a 0.6% reduction of severe hypoglycemic days (P = 0.269) in the postimplementation group. The average time to pharmacist intervention was 4 (± 3.5) hours with a 92% acceptance rate.
CONCLUSION
This study demonstrated the utility of pharmacist-led hypoglycemia reviews in the reduction of recurrent hypoglycemic events in the inpatient setting.
Topics: Humans; Blood Glucose; Hypoglycemia; Hypoglycemic Agents; Observational Studies as Topic; Pharmaceutical Services; Pharmacists; Pharmacy; Retrospective Studies
PubMed: 37696492
DOI: 10.1016/j.japh.2023.09.002 -
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 -
Tumori Dec 2023Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance...
Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real "Cinderella" of the Italian system.
Topics: Italy; Observational Studies as Topic
PubMed: 37029687
DOI: 10.1177/03008916231166469 -
BMC Geriatrics Aug 2023Efforts are needed to strengthen evidence and guidance for appropriate deprescribing for older nursing home (NH) residents, who are disproportionately affected by... (Review)
Review
BACKGROUND
Efforts are needed to strengthen evidence and guidance for appropriate deprescribing for older nursing home (NH) residents, who are disproportionately affected by polypharmacy and inappropriate prescribing. Given the challenges of conducting randomized drug withdrawal studies in this population, data from observational studies of routinely collected healthcare data can be used to identify patients who are apparent candidates for deprescribing and evaluate subsequent health outcomes. To improve the design and interpretation of observational studies examining determinants, risks, and benefits of deprescribing specific medications in older NH residents, we sought to propose a conceptual framework of the determinants of deprescribing in older NH residents.
METHODS
We conducted a scoping review of observational studies examining patterns and potential determinants of discontinuing or de-intensifying (i.e., reducing) medications for NH residents. We searched PubMed through September 2021 and included studies meeting the following criteria: conducted among adults aged 65 + in the NH setting; (2) observational study designs; (3) discontinuation or de-intensification as the primary outcome with key determinants as independent variables. We conceptualized deprescribing as a behavior through a social-ecological lens, potentially influenced by factors at the intrapersonal, interpersonal, organizational, community, and policy levels.
RESULTS
Our search in PubMed identified 250 potentially relevant studies published through September 2021. A total of 14 studies were identified for inclusion and were subsequently synthesized to identify and group determinants of deprescribing into domains spanning the five core social-ecological levels. Our resulting framework acknowledges that deprescribing is strongly influenced by intrapersonal, patient-level clinical factors that modify the expected benefits and risks of deprescribing, including index condition attributes (e.g., disease severity), attributes of the medication being considered for deprescribing, co-prescribed medications, and prognostic factors. It also incorporates the hierarchical influences of interpersonal differences relating to healthcare providers and family caregivers, NH facility and health system organizational structures, community trends and norms, and finally healthcare policies.
CONCLUSIONS
Our proposed framework will serve as a useful tool for future studies seeking to use routinely collected healthcare data sources and observational study designs to evaluate determinants, risks, and benefits of deprescribing for older NH residents.
Topics: Humans; Aged; Nursing Homes; Deprescriptions; Inappropriate Prescribing; Polypharmacy; Research Design; Observational Studies as Topic
PubMed: 37542226
DOI: 10.1186/s12877-023-04194-5