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BMC Pregnancy and Childbirth Oct 2023Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Skin-to-skin contact between mother and infant after birth is recommended to promote breastfeeding and maternal-infant bonding. However, its impact on the incidence of neonatal hypoglycaemia is unknown. We conducted a systematic review and meta-analysis to assess this.
METHODS
Published randomised control trials (RCTs), quasi-RCTs, non-randomised studies of interventions, cohort, or case-control studies with an intervention of skin-to-skin care compared to other treatment were included without language or date restrictions. The primary outcome was neonatal hypoglycaemia (study-defined). We searched 4 databases and 4 trial registries from inception to May 12, 2023. Quality of studies was assessed using Cochrane Risk of Bias 1 or Effective Public Health Practice Project Quality Assessment tools. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results were synthesised using RevMan 5.4.1 or STATA and analysed using random-effects meta-analyses where possible, otherwise with direction of findings tables. This review was registered prospectively on PROSPERO (CRD42022328322).
RESULTS
This review included 84,900 participants in 108 studies, comprising 65 RCTs, 16 quasi-RCTs, seven non-randomised studies of intervention, eight prospective cohort studies, nine retrospective cohort studies and three case-control studies. Evidence suggests skin-to-skin contact may result in a large reduction in the incidence of neonatal hypoglycaemia (7 RCTs/quasi-RCTs, 922 infants, RR 0.29 (0.13, 0.66), p < 0.0001, I = 47%). Skin-to-skin contact may reduce the incidence of admission to special care or neonatal intensive care nurseries for hypoglycaemia (1 observational study, 816 infants, OR 0.50 (0.25-1.00), p = 0.050), but the evidence is very uncertain. Skin-to-skin contact may reduce duration of initial hospital stay after birth (31 RCTs, 3437 infants, MD -2.37 (-3.66, -1.08) days, p = 0.0003, I = 90%, p for Egger's test = 0.02), and increase exclusive breastmilk feeding from birth to discharge (1 observational study, 1250 infants, RR 4.30 (3.19, 5.81), p < 0.0001), but the evidence is very uncertain.
CONCLUSION
Skin-to-skin contact may lead to a large reduction in the incidence of neonatal hypoglycaemia. This, along with other established benefits, supports the practice of skin-to-skin contact for all infants and especially those at risk of hypoglycaemia.
Topics: Infant, Newborn; Infant; Female; Humans; Breast Feeding; Mothers; Fetal Diseases; Hypoglycemia; Case-Control Studies; Observational Studies as Topic
PubMed: 37865757
DOI: 10.1186/s12884-023-06057-8 -
Clinical Microbiology and Infection :... Feb 2023Studies comparing shorter and longer antibiotic treatment durations are increasingly common. Randomized controlled trials (RCTs) are an ideal methodological approach to... (Review)
Review
BACKGROUND
Studies comparing shorter and longer antibiotic treatment durations are increasingly common. Randomized controlled trials (RCTs) are an ideal methodological approach to study antibiotic treatment durations; however, these trials can be logistically and financially challenging to conduct.
OBJECTIVES
In this narrative review, we sought to compare the strengths and limitations of observational study data with those of RCT data in evaluating antibiotic treatment durations. We used uncomplicated Gram-negative bacteraemia as an illustrative case example because several published RCTs and observational studies have been conducted in similar patient populations.
SOURCES
We searched MEDLINE for articles comparing treatment durations for gram-negative bacteremia from inception to June 9th, 2022. We included studies reporting on all-cause mortality and/or relapse at day 28-30. Data comparing short- versus long-course therapy were pooled by Bayesian random effects meta-analyses to assess the odds ratios (OR) of all-cause mortality and relapse at 30 days, stratified by study design. Parameters were summarized with median and 95% highest-density credible intervals (CrI). Posterior probabilities of OR > 1.0 were estimated. Observational studies were further examined to determine if and how they addressed potential sources of bias.
CONTENT
We identified 1671 unique records and included 10 studies (seven observational and three RCTs). With respect to 30-day mortality, the Bayesian posterior probability that a longer course of therapy was better (i.e. OR >1.0) was 42% in RCTs (OR, 0.94; 95% CrI, 0.51-1.68) and 91% in observational studies (OR, 1.25; 95% CrI, 0.88-1.73). No observational study fully addressed all potential sources of bias.
IMPLICATIONS
On the basis of our findings, we discuss future directions for antibiotic treatment duration trials, including approaches to limit sources of bias in observation data and novel trial designs.
Topics: Humans; Randomized Controlled Trials as Topic; Anti-Bacterial Agents; Bacteremia; Bias; Recurrence; Observational Studies as Topic
PubMed: 36108947
DOI: 10.1016/j.cmi.2022.09.002 -
Advances in Nutrition (Bethesda, Md.) Oct 2022Gastroparesis (Gp) is a delay in gastric emptying in the absence of a mechanical obstruction and has the capacity to cause symptoms that significantly impact a patient's...
Gastroparesis (Gp) is a delay in gastric emptying in the absence of a mechanical obstruction and has the capacity to cause symptoms that significantly impact a patient's quality of life. Dietary interventions are the first-line treatment in Gp, but the efficacy of different diets is unclear. This systematic review seeks to determine the effectiveness of dietary interventions on clinical outcomes in Gp. A literature search of MEDLINE Ovid from 1 March 2008 to 1 October 2021 was conducted to identify randomized controlled trials, cohort studies, and cross-sectional studies that reported dietary interventions in Gp. From the initial search, 2789 studies resulted. These were assessed by 2 independent reviewers and selected based on the primary outcomes of interest: changes in symptom-specific patient-reported outcomes and changes in gastric emptying time. A third reviewer resolved any discrepancies. Six adult studies (185 subjects) met the inclusion criteria, whereas no pediatric study did. Five of the included studies were randomized controlled trials and one was an observational study. The systematic review suggested low-fat diets, small-particle diets, diets with isoflavones, and foods considered bland, starchy, sweet, and salty did not exacerbate Gp symptoms. Small-particle diets and diets with isoflavones were found to improve gastric emptying time in patients. Additionally, small-particle diets were shown to reduce anxiety in comparison to large-particle diets. Of the randomized controlled trials, 80% were low risk of bias and 20% were fair risk of bias. The observational study was considered fair quality. The data presented in this review suggest specific dietary interventions could potentially improve Gp symptoms and gastric emptying in adult patients, particularly low-fat and small-particle diets. For pediatric Gp, data are lacking. The limited data available highlights a critical gap in the literature.
Topics: Adult; Cross-Sectional Studies; Diet; Gastroparesis; Humans; Isoflavones; Observational Studies as Topic; Quality of Life
PubMed: 35425953
DOI: 10.1093/advances/nmac037 -
BMC Medicine Mar 2023While epidemiological studies have found correlations between light at night (LAN) and health effects, none has so far investigated the impacts of LAN on population...
BACKGROUND
While epidemiological studies have found correlations between light at night (LAN) and health effects, none has so far investigated the impacts of LAN on population mortality yet. We aimed to estimate the relative risk for mortality from exposure to LAN in Mainland China.
METHODS
This time-stratified case-crossover nationwide study used NPP-VIIRS to obtain daily LAN data of Mainland China between 2015 and 2019. The daily mortality data were obtained from the Disease Surveillance Point System in China. Conditional Poisson regression models were applied to examine the relative risk (RR) for mortality along daily LAN in each county, then meta-analysis was performed to combine the county-specific estimates at the national or regional level.
RESULTS
A total of 579 counties with an average daily LAN of 4.39 (range: 1.02-35.46) were included in the main analysis. The overall RRs per 100 nW/cm/sr increases in daily LAN were 1.08 (95%CI: 1.05-1.11) for all-cause mortality and 1.08 (95%CI: 1.05-1.11) for natural-cause mortality. A positive association between LAN and all natural cause-specific mortality was observed, of which the strongest effect was observed on mortality caused by neuron system disease (RR = 1.32, 95%CI: 1.14-1.52). The results were robust in both younger and old, as well as in males and females. The more pronounced effect of LAN was observed in median LAN-level regions. Combined with an exposure-response curve, our study suggests a non-linear association between LAN and mortality in China.
CONCLUSIONS
Our study shows LAN is associated with mortality in China, particularly for neuron system disease-related mortality. These findings have important implications for public health policy establishment to minimize the health consequences of light pollution.
Topics: Female; Humans; Male; Cause of Death; China; Environmental Exposure; Observational Studies as Topic
PubMed: 36927443
DOI: 10.1186/s12916-023-02822-w -
BMC Medical Research Methodology Dec 2019All clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by...
BACKGROUND
All clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by publication of statistical analysis plans (SAPs) before data have been accessed to discern data-driven analyses from pre-planned analyses.
MAIN MESSAGE
Like clinical trials, recommendations for SAPs for observational studies increase the transparency and validity of findings. We appraised the applicability of recently developed guidelines for the content of SAPs for clinical trials to SAPs for observational studies. Of the 32 items recommended for a SAP for a clinical trial, 30 items (94%) were identically applicable to a SAP for our observational study. Power estimations and adjustments for multiplicity are equally important in observational studies and clinical trials as both types of studies usually address multiple hypotheses. Only two clinical trial items (6%) regarding issues of randomisation and definition of adherence to the intervention did not seem applicable to observational studies. We suggest to include one new item specifically applicable to observational studies to be addressed in a SAP, describing how adjustment for possible confounders will be handled in the analyses.
CONCLUSION
With only few amendments, the guidelines for SAP of a clinical trial can be applied to a SAP for an observational study. We suggest SAPs should be equally required for observational studies and clinical trials to increase their transparency and validity.
Topics: Data Interpretation, Statistical; Humans; Observational Studies as Topic; Reproducibility of Results; Research Design
PubMed: 31818263
DOI: 10.1186/s12874-019-0879-5 -
Clinical Drug Investigation Aug 2023Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of... (Review)
Review
Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.
BACKGROUND
Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors.
METHODS
A systematic search was conducted in PubMed using the search string "(Imraldi OR Hadlima OR SB5 OR Benepali OR Brenzys OR SB4) AND (preference) AND (device)" covering the period from 28 January 2016 (first introduction of SB4) to 31 May 2022. Only articles and abstracts on usability or preference-rating of SB4 and SB5 autoinjectors (AI) written in English were selected. Additional papers identified via manual search supplemented the retrieved papers.
RESULTS
A total of nine articles and one conference poster were selected (seven surveys, one observational study, and two phase II studies). Overall, participants of the studies included nurses and rheumatologists, as well as patients who were from three medical specialties where these medicines are most commonly used (rheumatology, gastroenterology, and dermatology). The majority of patients and healthcare professionals rated ease of use and ease of grip as the most important device attributes. SB4/Pen and SB5/Pen were mostly preferred over their prefilled syringes (PFS), Enbrel/Pen, and Humira/Pen.
CONCLUSION
The analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Delivery of Health Care; Dietary Supplements; Etanercept; Observational Studies as Topic
PubMed: 37615857
DOI: 10.1007/s40261-023-01284-5 -
BMJ Open Aug 2021Mechanical ventilatory is a crucial element of acute brain injured patients' management. The ventilatory goals to ensure lung protection during acute respiratory failure...
INTRODUCTION
Mechanical ventilatory is a crucial element of acute brain injured patients' management. The ventilatory goals to ensure lung protection during acute respiratory failure may not be adequate in case of concomitant brain injury. Therefore, there are limited data from which physicians can draw conclusions regarding optimal ventilator management in this setting.
METHODS AND ANALYSIS
This is an international multicentre prospective observational cohort study. The aim of the 'multicentre observational study on practice of ventilation in brain injured patients'-the VENTIBRAIN study-is to describe the current practice of ventilator settings and mechanical ventilation in acute brain injured patients. Secondary objectives include the description of ventilator settings among different countries, and their association with outcomes. Inclusion criteria will be adult patients admitted to the intensive care unit (ICU) with a diagnosis of traumatic brain injury or cerebrovascular diseases (intracranial haemorrhage, subarachnoid haemorrhage, ischaemic stroke), requiring intubation and mechanical ventilation and admission to the ICU. Exclusion criteria will be the following: patients aged <18 years; pregnant patients; patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation. Data related to clinical examination, neuromonitoring if available, ventilator settings and arterial blood gases will be recorded at admission and daily for the first 7 days and then at day 10 and 14. The Glasgow Outcome Scale Extended on mortality and neurological outcome will be collected at discharge from ICU, hospital and at 6 months follow-up.
ETHICS AND DISSEMINATION
The study has been approved by the Ethic committee of Brianza at the Azienda Socio Sanitaria Territoriale-Monza. Data will be disseminated to the scientific community by abstracts submitted to the European Society of Intensive Care Medicine annual conference and by original articles submitted to peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04459884.
Topics: Adult; Brain; Brain Ischemia; Humans; Intensive Care Units; Lung; Multicenter Studies as Topic; Observational Studies as Topic; Prospective Studies; Respiration, Artificial; Stroke
PubMed: 34380722
DOI: 10.1136/bmjopen-2020-047100 -
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 -
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 -
Epilepsy & Behavior : E&B May 2023This study aimed to systematically review the published literature evaluating the association between physical activity and cognitive function in people with epilepsy... (Review)
Review
BACKGROUND
This study aimed to systematically review the published literature evaluating the association between physical activity and cognitive function in people with epilepsy (PWE).
METHODS
A comprehensive search of PubMed, Cochrane, Embase, and PsychInfo was performed on June 20, 2022. Studies were excluded if they were not available in the English language, contained animal data only, did not include any original data, were not peer-reviewed, or did not include PWE as a discrete group. PRISMA guidelines were followed. The GRADE scale was used to assess the risk of bias.
RESULTS
Six studies were identified with a total of 123 participants. These included one observational study and five interventional studies, only one of which was a randomized controlled trial. In all studies, there was a positive association between physical activity and cognitive function in PWE. Both interventional studies showed improvement in at least one domain of cognitive functioning, though there was heterogeneity in the outcome measures used.
CONCLUSIONS
There is a potential positive association between physical activity and cognitive function in PWE, but available data is limited by heterogeneity, small sample size, and an overall lack of published studies in this area of research. There is a need for more robust studies to be performed in larger samples of PWE.
Topics: Animals; Exercise; Cognition; Epilepsy; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 36940504
DOI: 10.1016/j.yebeh.2023.109170