-
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 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 -
Haematologica Mar 2020Plasminogen deficiency is an ultra-rare multisystem disorder characterized by the development of fibrin-rich pseudomembranes on mucous membranes. Ligneous... (Review)
Review
Plasminogen deficiency is an ultra-rare multisystem disorder characterized by the development of fibrin-rich pseudomembranes on mucous membranes. Ligneous conjunctivitis, which can result in vision impairment or loss, is the most frequent symptom reported. Affected systems may also include the respiratory tract, oropharynx, female reproductive tract, gingiva, middle ear, renal collecting system, skin and central nervous system. Untreated, plasminogen deficiency may result in significant reduction in quality of life and morbidity with potential life-threatening complications. Non-specific therapies are inadequate and plasminogen concentrates are not commercially available. The current understanding of plasminogen deficiency and management of disease symptoms and its progression are based on case reports/series and two small clinical trials. To date there has never been a comprehensive, international study to examine the natural history or optimal therapeutic intervention; knowledge gaps include identification of contributing factors and triggers of disease manifestations, inability to predict disease course, and insufficient real-world data for use of therapeutics. We have created an international, observational study (HISTORY) in a large cohort of persons with plasminogen deficiency and first-degree family members to address these gaps and to advance knowledge and care. HISTORY will build upon the established relationship between the Indiana Hemophilia and Thrombosis Center and the Fondazione Angelo Bianchi Bonomi, IRCCS Ca' Granda Ospedale Maggiore Policlinico - University of Milan and will utilize a modified version of the Prospective Rare Bleeding Disorders Database (PRO-RBDD). A biorepository containing samples from subjects with plasminogen deficiency will be established. This article describes the rationale behind the study and efforts towards its goals.
Topics: Conjunctivitis; Humans; Observational Studies as Topic; Plasminogen; Prospective Studies; Quality of Life; Registries
PubMed: 32001536
DOI: 10.3324/haematol.2019.241158 -
The Journal of Trauma and Acute Care... Dec 2021While the concept of a "target trial"-optimizing the quality of observational studies by attempting to emulate the ideal world conditions of a randomized controlled... (Review)
Review
BACKGROUND
While the concept of a "target trial"-optimizing the quality of observational studies by attempting to emulate the ideal world conditions of a randomized controlled trial-was first expounded over a decade ago, the take up of this concept in the design and analysis of trials in trauma is lacking. The target trial approach avoids common errors in observational research to increase its scientific validity as well as potentially enable causal questions to be answered without the expense and intricacies of a randomized controlled trial. This review article briefly introduces the reader to the concepts and utility of a "target trial" approach before providing demonstrations of its application in the subject area of chest trauma.
METHODS
Four articles published in the last 5 years-two case control and two cohort studies-are chosen and considered in terms of their causal question; study population; inclusion and exclusion criteria; designation of time 0; clarity of the follow-up period; study outcomes; methods to minimize confounding; results; overall issues regarding study time; and the presence of avoidable errors such as introduction of immortal time bias or information bias.
RESULTS
Two of the studies had an unclear causal question; none of the studies designated a time 0; the follow-up period was unclear for all but one of the studies; and one study had a serious issue with information bias resulting from differential misclassification.
CONCLUSION
Failure to emulate a "target trial" framework may lead to serious methodologic issues in observational research. Expansion of the awareness of this approach in trauma literature will improve the quality of our observational research and potentially translate into significant benefits for our patients.
Topics: Bias; Humans; Observational Studies as Topic; Quality Improvement; Randomized Controlled Trials as Topic; Research Design; Thoracic Injuries
PubMed: 34369436
DOI: 10.1097/TA.0000000000003375 -
Current Hypertension Reports Nov 2020E-cigarettes (e-cigs) release toxic chemicals known to increase blood pressure (BP) levels. The effects of e-cigs on BP, however, remain unknown. Studying BP may help... (Review)
Review
PURPOSE OF REVIEW
E-cigarettes (e-cigs) release toxic chemicals known to increase blood pressure (BP) levels. The effects of e-cigs on BP, however, remain unknown. Studying BP may help characterize potential cardiovascular risks of short- and long-term e-cig use. We summarized published studies on the association of e-cig use with BP endpoints.
RECENT FINDINGS
Thirteen e-cig trials (12 cross-over designs) and 1 observational study evaluated systolic and diastolic blood pressure (SBP and DBP). All trials included at least one e-cig arm with nicotine, 6 a no-nicotine e-cig arm, and 3 a placebo arm. SBP/DBP increased in most nicotine e-cig arms, in some non-nicotine e-cig arms, and in none of the placebo arms. The observational study followed e-cig users and nonsmokers for 3.5 years with inconsistent findings. The use of e-cigs with and without nicotine may result in short-term elevations of both SBP and DBP. Prospective studies that investigate the long-term cardiovascular impact of e-cig use are needed.
Topics: Blood Pressure; Electronic Nicotine Delivery Systems; Humans; Hypertension; Observational Studies as Topic; Prospective Studies; Vaping
PubMed: 33230755
DOI: 10.1007/s11906-020-01119-0 -
BMC Oral Health Dec 2022Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make...
BACKGROUND
Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make sense of the data, and, ultimately, use the data to create meaningful impact all influence the success of using patient-reported outcomes.
OBJECTIVES
The primary objective is to assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following dental procedures and assess patients' satisfaction with pain management following dental surgical procedures. Secondary objectives are to: 1) assess post-operative pain management strategies 1 week following dental surgical procedures, as recommended by practitioners and reported by patients, and 2) evaluate practitioner and patient acceptance of the FollowApp.Care post visit patient monitoring technology (FollowApp.Care). We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload.
DESIGN AND METHODS
We describe the protocol for an observational study involving the use of the FollowApp.Care platform, an innovative mobile application that collects dental patients' assessments of their post-operative symptoms (e.g., pain). The study will be conducted in collaboration with the National Dental Practice-based Research Network, a collective Network of dental practices that include private and group practices, public health clinics, community health centers and Federal Qualified Health Centers, academic institutional settings, and special patient populations. We will recruit a minimum of 150 and up to 215 dental providers and up to 3147 patients who will receive push notifications through text messages FollowApp.Care on their mobile phones at designated time intervals following dental procedures. This innovative approach of implementing an existing and tested mobile health system technology into the real-world dental office setting will actively track pain and other complications following dental procedures. Through patients' use of their mobile phones, we expect to promptly and precisely identify specific pain levels and other issues after surgical dental procedures. The study's primary outcome will be the patients' reported pain experiences. Secondary outcomes include pain management strategies and medications implemented by the patient and provider and perceptions of usefulness and ease of use by patients and providers.
Topics: Humans; Cell Phone; Text Messaging; Patient Satisfaction; Pain, Postoperative; Dentistry; Observational Studies as Topic
PubMed: 36494795
DOI: 10.1186/s12903-022-02573-9 -
Sexual and Reproductive Health Matters 2021Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during... (Review)
Review
Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during intercourse. To inform WHO's self-care interventions guideline, we conducted a systematic review of the peer-reviewed literature to answer the question: does use of lubricants during or prior to sex result in improved sexual health and well-being. We searched PubMed, CINAHL, LILACS and EMBASE on 8 July 2020 for effectiveness, values and preferences, and cost data related to commercially available vaginal and anal lubricants. Data were systematically extracted and qualitatively synthesised. Effectiveness evidence was summarised in GRADE evidence profiles. Seven studies met the effectiveness review criteria. Two randomised trials found lubricant use led to improved female sexual well-being and had no impact on incidence of human papillomavirus (moderate certainty evidence). One observational study with gay and bisexual men showed lubricants were associated with increased reports of pain during receptive intercourse and no difference in pain during insertive intercourse, but a reduced degree of pain in both types of intercourse (low/very low certainty evidence). One observational study with female breast cancer survivors found better outcomes of vaginal dryness and dyspareunia with lubricant use (very low certainty evidence). Twenty-one values and preferences studies from diverse populations globally found that most individuals supported lubricant use for reasons of comfort/reduced pain and sexual pleasure. No cost studies were identified. Although evidence is limited, lubricants appear to offer an acceptable approach to improving sexual health and well-being.
Topics: Bisexuality; Coitus; Female; Humans; Lubricants; Male; Observational Studies as Topic; Sexual Behavior; Sexual Health
PubMed: 35315312
DOI: 10.1080/26410397.2022.2044198 -
Nursing in Critical Care May 2022Critically ill patients are more likely to survive intensive care than ever before due to advances in treatment. However, a proportion subsequently experiences...
BACKGROUND
Critically ill patients are more likely to survive intensive care than ever before due to advances in treatment. However, a proportion subsequently experiences post-intensive care syndrome (PICS) incurring substantial personal, social, and economic costs. PICS is a debilitating set of physical, psychological, and cognitive sequelae but the size and characteristics of the affected population have been difficult to describe, impeding progress in intensive care rehabilitation.
AIMS AND OBJECTIVES
The aim of this protocol is to describe recovery after admission to intensive care unit (ICU) and the predictors, correlates, and patient-reported outcomes for those experiencing PICS. The study will support the development of screening, diagnostic, and outcome measures to improve post-ICU recovery.
DESIGN
A prospective, multi-site observational study in three ICUs in Brisbane, Australia. Following consent, data will be collected from clinical records and using validated self-report instruments from 300 patients, followed up at 6 weeks and 6 months post ICU discharge.
METHODS
TOPIC is a prospective, multi-site observational study using self-report and clinical data on risk factors, including comorbidities, and outcomes. Data will be collected with consent from hospital records and participants 6 weeks and 6months post ICU discharge.
RESULTS
The main outcome measures will be self-reported physical, cognitive, and psychological function 6 weeks and 6 months post-ICU discharge.
RELEVANCE TO CLINICAL PRACTICE
This protocol provides a methodological framework to measure recovery and understand PICS. Data analysis will describe characteristics associated with recovery and PICS. The subsequent prediction and screening tools developed then aim to improve the effectiveness of post-ICU prevention and rehabilitation through more targeted screening and prediction and found a program of research developing a more tailored approach to PICS.
Topics: Critical Care; Critical Illness; Humans; Intensive Care Units; Observational Studies as Topic; Prospective Studies; Quality of Life
PubMed: 33609311
DOI: 10.1111/nicc.12613