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Nicotine & Tobacco Research : Official... Jan 2023Indigenous North Americans have the highest cigarette smoking prevalence among all racial and ethnic groups in the United States. We seek to identify effective... (Review)
Review
INTRODUCTION
Indigenous North Americans have the highest cigarette smoking prevalence among all racial and ethnic groups in the United States. We seek to identify effective components of smoking cessation interventions in Indigenous people in the United States associated with favorable cessation outcomes.
METHODS
A review of literature studying smoking cessation interventions in Indigenous North Americans (American Indians and Alaska Natives) from January 2010 through August 2021 was completed. The primary objective of this study was to identify components of interventions associated with positive smoking cessation outcomes in Indigenous people. The studies identified were synthesized in a meta-narrative approach.
RESULTS
Ten studies out of 608 titles were included (6 randomized trials, 2 single-arm studies, 1 cohort study, and 1 prospective observational study). Five categories of smoking cessation interventions were identified; phone or web-based tools, culturally-tailored interventions, the inclusion of Indigenous study personnel, pharmaceutical cessation aids, and behavioral health interventions. Phone and web tools, cultural tailoring, and inclusion of Indigenous personnel conditions inconsistently influenced smoking cessation. Pharmaceutical aids were viewed favorably among participants. Individualized behavioral counseling sessions were effective at promoting smoking cessation, as was input from local communities in the planning and implementation phases of study.
CONCLUSION
A successful smoking cessation intervention in Indigenous North Americans includes Tribal or community input in intervention design and implementation; should provide individualized counseling sessions for participants, and offer access to validated smoking cessation tools including pharmacotherapy.
IMPLICATIONS
This study identifies a paucity of smoking interventions utilizing standard of care interventions in Indigenous North Americans. Standard of care interventions including individualized cessation counseling and pharmacotherapy were effective at promoting cessation. The use of novel culturally tailored cessation interventions was not more effective than existing evidence-based care with the exception of including Tribal and local community input in intervention implementation. Future smoking cessation interventions in Indigenous North Americans should prioritize the use of standard of care cessation interventions.
Topics: Humans; United States; Smoking Cessation; Cohort Studies; Behavior Therapy; Counseling; Population Groups; Observational Studies as Topic
PubMed: 35869642
DOI: 10.1093/ntr/ntac181 -
Seminars in Radiation Oncology Oct 2019A principle goal of research in Oncology is to determine the optimal treatment for our patients. This often takes the form of comparing 2 existing therapies to one... (Review)
Review
A principle goal of research in Oncology is to determine the optimal treatment for our patients. This often takes the form of comparing 2 existing therapies to one another to determine which is superior, or to introduce a new therapy and determine if it is superior or noninferior to the existing standard of care. This type of research is termed comparative effectiveness research (CER), and the gold-standard is through the conduct of randomized trials. This is the preferred approach, and the only true methodologic approach that can assign a cause-and-effect relationship between a treatment effect and the observed outcome. An alternative approach that is gaining popularity is the use of population-based registry analysis given that it is quicker, cheaper, and easier to perform. However, there are unavoidable forms of bias and confounding that exist when using observational research to perform CER, and recent evidence suggests that population-based CER often results in erroneous results, and that statistical methods to minimize bias are ineffective to overcome the numerous limitations of these databases. In this article, the strengths and weaknesses of both randomized and observational research will be discussed.
Topics: Comparative Effectiveness Research; Data Management; Humans; Medical Oncology; Observational Studies as Topic; Research Design
PubMed: 31472729
DOI: 10.1016/j.semradonc.2019.05.011 -
Advances in Therapy Jun 2023Since their approval by the Food and Drug Administration (FDA) in 1989, proton pump inhibitors (PPIs) have become one of the most highly utilized drugs in the United... (Review)
Review
Since their approval by the Food and Drug Administration (FDA) in 1989, proton pump inhibitors (PPIs) have become one of the most highly utilized drugs in the United States, assuming a position as one of the top 10 most prescribed medications in the country. The purpose of PPIs is to limit the amount of gastric acid secreted by the parietal cells via irreversible inhibition of the H+/K+-ATPase pump, therefore maintaining an elevated gastric acid pH of greater than 4 for 15-21 h. Even though PPIs have many clinical uses, they are not without their adverse effects, mimicking achlorhydria. Besides electrolyte abnormalities and vitamin deficiencies, long-term use of PPIs has been linked to acute interstitial nephritis, bone fractures, poor COVID-19 infection outcomes, pneumonia, and possibly an increase in all-cause mortality. The causality between PPI use and increased mortality and disease risk can be questioned since most studies are observational. Confounding variables can greatly affect an observational study and explain the wide-ranging associations with the use of PPIs. Patients on PPIs are generally older, obese, sicker with a higher number of baseline morbidities, and on more medications than the compared PPI non-users. These findings suggest that PPI users are at a higher risk of mortality and complications based on pre-existing conditions. This narrative review aims to update readers on the concerning effects that proton pump inhibitor use can have on patients and give providers a resource to create informed decisions on appropriate PPI use.
Topics: Humans; Proton Pump Inhibitors; COVID-19; Fractures, Bone; Kidney; Observational Studies as Topic
PubMed: 37140707
DOI: 10.1007/s12325-023-02476-3 -
Skinmed 2021This study assessed relationship between hair loss and professional success by characterizing severity of hair loss among current white male chief executive officers... (Review)
Review
This study assessed relationship between hair loss and professional success by characterizing severity of hair loss among current white male chief executive officers (CEOs) in the United States. This observational study of androgenic alopecia among business executives was conducted by grading anterior and lateral view photographs of CEOs aged 50-69 years. Blinded, independent two-reviewer assessments of androgenic alopecia were performed based on the Hamilton-Norwood Hair Loss Scale. In all, 68 CEOs were included in this review, with 34 individuals each in the age groups of 50-59 and 60-69 years. Significant hair loss occurred in 18% (6/34) of the CEOs aged 50-59 years and in 35% (12/34) of those aged 60-69 years. The findings of the study established that among white male CEOs aged 50-69 years, significant hair loss occurred less frequently than previously reported for the general white male population.
Topics: Alopecia; Hair; Humans; Male; Observational Studies as Topic; United States
PubMed: 34526203
DOI: No ID Found -
Revista Espanola de Cardiologia... Jan 2022This review provides a practical guide to the essentials of survival analysis and their reporting in cardiovascular studies, although most of its key content can be... (Review)
Review
This review provides a practical guide to the essentials of survival analysis and their reporting in cardiovascular studies, although most of its key content can be extrapolated to other medical fields. This is the first in a series of 2 educational articles laying the groundwork to address the most relevant statistical issues in survival analyses, which will smoothly drive the reader from the most basic analyses to the most complex situations. The focus will be on the type and shape of survival data, and the most common statistical methods, such as nonparametric, parametric and semiparametric models. Their adequacy, interpretation, advantages and disadvantages are illustrated by examples from the field of cardiovascular research. This article ends with a set of recommendations to guide the strategy of survival analyses for a randomized clinical trial and observational studies. Other topics, such as competing risks, multistate models and recurrent-event methods will be addressed in the second article.
Topics: Observational Studies as Topic; Randomized Controlled Trials as Topic; Survival Analysis
PubMed: 34215548
DOI: 10.1016/j.rec.2021.06.003 -
Acta Paediatrica (Oslo, Norway : 1992) May 2020Neonates frequently require supplementary oxygen but may develop complications if the oxygen saturation is outside the target range. This review aimed to determine... (Review)
Review
AIM
Neonates frequently require supplementary oxygen but may develop complications if the oxygen saturation is outside the target range. This review aimed to determine whether the algorithms used in closed loop automated oxygen control systems influenced their efficacy and whether use of the systems reduced relevant, long-term neonatal complications.
METHODS
A literature search was conducted using PubMed and Google Scholar. The search terms were 'closed loop' or 'automat*', 'oxygen' and 'neonat*'.
RESULTS
Eighteen studies were identified: sixteen comparison clinical studies, an observational study and an animal study. Overall, closed loop automated oxygen control was associated with an increased percentage of time spent within the target oxygen saturation range and there were fewer manual adjustments to the inspired oxygen concentration when compared with manual oxygen control. The systems were effective in infants on non-invasive respiratory support or mechanically ventilated, but no study included term-born infants. No long-term data were available to determine if complications of oxygen toxicity were reduced.
CONCLUSION
Closed loop automated oxygen control has been shown in short term trials including preterm and low birth weight infants to improve target saturation achievement. Whether long-term outcomes will be improved with their use requires investigation.
Topics: Humans; Hyperoxia; Infant; Infant, Newborn; Infant, Premature; Observational Studies as Topic; Oxygen; Oxygen Inhalation Therapy
PubMed: 31715041
DOI: 10.1111/apa.15089 -
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 -
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 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 -
Medwave Sep 2019Observational studies evaluate variables of interest in a sample or a population, without intervening in them. They can be descriptive if they focus on the description... (Review)
Review
Observational studies evaluate variables of interest in a sample or a population, without intervening in them. They can be descriptive if they focus on the description of variables, or analytical when comparison between groups is made to establish associations through statistical inference. Cross-sectional studies and ecologicalalso called correlationalstudies are two observational methodological designs. Cross-sectional studies collect the data of the exposure variable and the outcome at the same time, to describe characteristics of the sample or to study associations. Ecological studies describe and analyze correlations among different variables, and the unit of analysis is aggregated data from multiple individuals. In both types of studies, associations of interest for biomedical research can be established, but no causal relationships should be inferred. This is the second of a methodological series of articles on general concepts in biostatistics and clinical epidemiology developed by the Chair of Scientific Research Methodology at the School of Medicine, University of Valparaíso, Chile. In this review, we address general theoretical concepts about cross-sectional and ecological studies, including applications, measures of association, advantages, disadvantages, and reporting guidelines. Finally, we discuss some concepts about observational designs relevant to undergraduate and graduate students of health sciences.
Topics: Biomedical Research; Biostatistics; Cross-Sectional Studies; Humans; Observational Studies as Topic; Research Design
PubMed: 31596838
DOI: 10.5867/medwave.2019.08.7698