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Age and Ageing May 2022Falls remain a common and debilitating problem in hospitals worldwide. The aim of this study was to investigate the effects of falls prevention interventions on falls... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Falls remain a common and debilitating problem in hospitals worldwide. The aim of this study was to investigate the effects of falls prevention interventions on falls rates and the risk of falling in hospital.
DESIGN
Systematic review and meta-analysis.
PARTICIPANTS
Hospitalised adults.
INTERVENTION
Prevention methods included staff and patient education, environmental modifications, assistive devices, policies and systems, rehabilitation, medication management and management of cognitive impairment. We evaluated single and multi-factorial approaches.
OUTCOME MEASURES
Falls rate ratios (rate ratio: RaR) and falls risk, as defined by the odds of being a faller in the intervention compared to control group (odds ratio: OR).
RESULTS
There were 43 studies that satisfied the systematic review criteria and 23 were included in meta-analyses. There was marked heterogeneity in intervention methods and study designs. The only intervention that yielded a significant result in the meta-analysis was education, with a reduction in falls rates (RaR = 0.70 [0.51-0.96], P = 0.03) and the odds of falling (OR = 0.62 [0.47-0.83], P = 0.001). The patient and staff education studies in the meta-analysis were of high quality on the GRADE tool. Individual trials in the systematic review showed evidence for clinician education, some multi-factorial interventions, select rehabilitation therapies, and systems, with low to moderate risk of bias.
CONCLUSION
Patient and staff education can reduce hospital falls. Multi-factorial interventions had a tendency towards producing a positive impact. Chair alarms, bed alarms, wearable sensors and use of scored risk assessment tools were not associated with significant fall reductions.
Topics: Humans; Cognitive Dysfunction; Exercise; Hospitals; Risk Assessment; Accidental Falls
PubMed: 35524748
DOI: 10.1093/ageing/afac077 -
Expert Opinion on Drug Metabolism &... Apr 2021Precision drug therapy requires accounting for pertinent factors in pharmacokinetic (PK) inter-individual variability (., pharmacogenetics, diseases, polypharmacy, and... (Review)
Review
Precision drug therapy requires accounting for pertinent factors in pharmacokinetic (PK) inter-individual variability (., pharmacogenetics, diseases, polypharmacy, and natural product use) that can cause sub-therapeutic or adverse effects. Although each of these individual factors can alter victim drug PK, multi-factorial interactions can cause additive, synergistic, or opposing effects. Determining the magnitude and direction of these complex multi-factorial effects requires understanding the rate-limiting redundant and/or sequential PK processes for each drug. Perturbations in drug-metabolizing enzymes and/or transporters are integral to single- and multi-factorial PK interactions. Examples of single factor PK interactions presented include gene-drug (pharmacogenetic), disease-drug, drug-drug, and natural product-drug interactions. Examples of multi-factorial PK interactions presented include drug-gene-drug, natural product-gene-drug, gene-gene-drug, disease-natural product-drug, and disease-gene-drug interactions. Clear interpretation of multi-factorial interactions can be complicated by study design, complexity in victim drug PK, and incomplete mechanistic understanding of victim drug PK. Incorporation of complex multi-factorial PK interactions into precision drug therapy requires advances in clinical decision tools, intentional PK study designs, drug-metabolizing enzyme and transporter fractional contribution determinations, systems and computational approaches (., physiologically-based pharmacokinetic modeling), and PK phenotyping of progressive diseases.
Topics: Animals; Drug Interactions; Humans; Membrane Transport Proteins; Models, Biological; Pharmaceutical Preparations; Pharmacogenetics; Pharmacokinetics; Precision Medicine; Research Design
PubMed: 33339463
DOI: 10.1080/17425255.2021.1867105 -
Clinical and Experimental Emergency... Mar 2024The goal of a clinical study is to determine the factors associated with a disease and to assess the efficacy and safety of an investigational drug, procedure, or...
The goal of a clinical study is to determine the factors associated with a disease and to assess the efficacy and safety of an investigational drug, procedure, or device. Since clinical study designs vary due to unique requirements of individual studies, the aims of this report are to educate researchers on the different types of studies and to assist researchers in choosing the optimal study type to fulfill their individual requirements. Clinical studies are classified into the two main types, observational studies and clinical trials, depending on the presence or absence of an intervention. Observational studies include case-control studies, cohort studies, and cross-sectional studies. Case-control and cohort studies may be prospective or retrospective, and case-control studies may be nested or not. Clinical trials may be pragmatic and may be controlled or noncontrolled; randomized or nonrandomized; open label or blinded; and parallel, crossover, or factorial. These observational and clinical trial designs are reviewed. Each type of clinical study has advantages and disadvantages. Therefore, researchers must consider these in choosing the design best suited for achieving their study objectives.
PubMed: 37280050
DOI: 10.15441/ceem.23.036 -
Trials Dec 2023Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this...
BACKGROUND
Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this factorial, single-blind, randomized controlled trial is to analyze and compare the surgical outcomes, functional visual outcomes, complications, and quality of life associated with RRD repair using (A) pars plana vitrectomy only (PPV) or PPV with scleral buckle (PPV-SB) and (B) sulfur hexafluoride gas (SF) or perfluoropropane gas (CF) tamponade.
METHODS
Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF or CF gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between the groups. Patients will be followed using multimodal imaging and quality of life questionnaires after the surgical repair until 1 year postoperative. The primary outcome will be a single-surgery anatomic success (SSAS), defined as the absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results.
DISCUSSION
This will be the first 2 × 2 factorial RCT examining repair techniques in primary RRD. It will also be the first RCT to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina's recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with CF is necessary.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05863312. Registered on 18 May 2023.
Topics: Humans; Retinal Detachment; Retrospective Studies; Quality of Life; Single-Blind Method; Treatment Outcome; Visual Acuity; Vitrectomy; Randomized Controlled Trials as Topic
PubMed: 38124155
DOI: 10.1186/s13063-023-07815-x -
BMJ Open Jan 2022To develop the Psychiatric Nurse Self-Efficacy Scales, and to examine their reliability and validity.
OBJECTIVES
To develop the Psychiatric Nurse Self-Efficacy Scales, and to examine their reliability and validity.
DESIGN
We developed the Improved Self-Efficacy Scale (ISES) and Decreased Self-Efficacy Scale (DSES) using existing evidence. Statistical analysis was conducted on the data to test reliability and validity.
SETTING
The study's setting was psychiatric facilities in three prefectures in Japan.
PARTICIPANTS
Data from 514 valid responses were extracted of the 786 responses by psychiatric nurses.
OUTCOME MEASURES
The study measured the reliability and validity of the scales.
RESULTS
The ISES has two factors ('Positive changes in the patient' and 'Prospect of continuing in psychiatric nursing') and the DSES has three ('Devaluation of own role as a psychiatric nurse', 'Decrease in nursing ability due to overload' and 'Difficulty in seeing any results in psychiatric nursing'). With regard to scale reliability, the Cronbach's alpha coefficient was 0.634-0.845. With regard to scale validity, as the factorial validity of the ISES and DSES, for the ISES, χ/df (110.625/37) ratio=2.990 (p<0.001), goodness-of-fit index (GFI)=0.962, adjusted GFI (AGFI)=0.932, comparative fit index (CFI)=0.967 and root mean square error of approximation (RMSEA)=0.062; for the DSES, χ/df (101.982/37) ratio=2.756 (p<0.001), GFI=0.966, AGFI=0.940, CFI=0.943, RMSEA=0.059 and Akaike Information Criterion=159.982. The concurrent validity of the General Self-Efficacy Scale was r=0.149-0.446 (p<0.01) for ISES and r=-0.154 to -0.462 (p<0.01) for DSES, and the concurrent validity of the Stress Reaction Scale was r=-0.128 to 0.168 for ISES, r=0.214-0.398 for DSES (p<0.01).Statistical analyses showed the scales to be reliable and valid measures.
CONCLUSIONS
The ISES and DSES can accurately assess psychiatric nurses' self-efficacy. Using these scales, it is possible to formulate programmes for improving psychiatric nurses' feelings of self-efficacy.
Topics: Cross-Sectional Studies; Humans; Nurses; Psychiatric Nursing; Psychometrics; Reproducibility of Results; Self Efficacy
PubMed: 34996799
DOI: 10.1136/bmjopen-2021-055922 -
Psychometric properties and factorial invariance of the Farsi version of the Stress Mindset Measure.Frontiers in Psychology 2022The Stress Mindset Measure consists of eight items to assess whether individuals hold a stress-is-enhancing or a stress-is-debilitating mindset. The current research is...
The Stress Mindset Measure consists of eight items to assess whether individuals hold a stress-is-enhancing or a stress-is-debilitating mindset. The current research is a cross-sectional study and aimed to investigate the factor structure, internal consistency reliability, and construct and convergent validity of the Farsi version of the Stress Mindset Measure (SMM). Prior to conducting the study, forward and backward translations of the SMM were performed. Using the convenience sampling method, we recruited 400 none-clinical sample (161 men and 239 women; aged 18 to 69). We utilized SPSS version 24, Amos, and Mplus 7.1 software to analyze the data. Results revealed satisfactory reliability and validity indexes for the Farsi version of the Stress Mindset Measure. The internal consistency of the Farsi version of the Stress Mindset Measure was in the excellent range (α = 0.87). The results of the confirmatory factorial analysis revealed two factors of the Stress Mindset Measure instead of the single factor suggested by the previous studies (fitness indices for the two-factor model were RMSEA = 0.78, CFI = 0.96, and TLI = 0.94). Moreover, we found that the stress-is-debilitating mindset is positively associated with stress ( = 0.233), depression ( = 0.163), and anxiety ( = 0.197). However, this mindset has been found to have no significant relationship with cognitive strategies of emotion regulation and life satisfaction. Also, findings showed no significant correlation between the stress-is-enhancing mindsets and the other variables. The results of this study suggest that the Farsi SMM has proper psychometric properties to assess stress mindsets.
PubMed: 36160509
DOI: 10.3389/fpsyg.2022.945673 -
Journal of the National Cancer Institute Sep 2017Factorial 2 × 2 designs can be used to combine evaluation of two treatments in a single study. The standard analysis approach is based on a factorial analysis that... (Review)
Review
Factorial 2 × 2 designs can be used to combine evaluation of two treatments in a single study. The standard analysis approach is based on a factorial analysis that evaluates each treatment by pooling data over the other treatment. This approach relies on the assumption that the effect of each treatment is not substantially affected by the other treatment. In many oncology settings, this no-interaction assumption cannot be adequately supported at the time the trial is designed. In this Commentary, we consider current practices for the design and analysis of factorial trials by performing a survey of factorial treatment trials published in the Journal of the National Cancer Institute, Journal of Clinical Oncology, and the New England Journal of Medicine (2007-2016). The protocol-specified sample size was derived based on the factorial (pooled) analysis in 96.7% of the 30 identified trials, and the factorial analysis was specified as the primary analysis in 90.0% of these identified trials. An interaction complicating study interpretation was reported in 16.7% of the trials. We provide recommendations for matching the trial analysis and design to the study goals to account for possible interaction and illustrate the recommendations on the data from several published trials.
Topics: Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Drug Interactions; Humans; Neoadjuvant Therapy; Neoplasms; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 28954288
DOI: 10.1093/jnci/djx146 -
International Journal of Environmental... Apr 2022Aggressive beliefs and attitudes are increasingly present in adolescents, and it can be argued that they are a prevalent feature of adolescence. Michel, Pace, Edun,...
Aggressive beliefs and attitudes are increasingly present in adolescents, and it can be argued that they are a prevalent feature of adolescence. Michel, Pace, Edun, Sawhney, and Thomas’s (2014) original thirty-item scale was later shortened to a more parsimonious eight-item scale (ABA-SF). This study addresses the adaptation and validation of the brief Aggressive Beliefs and Attitudes Scale to Spanish adolescents. The sample comprised a group of Spanish adolescents (N = 771, M age = 14.01 years). A total of two studies were undertaken: (1) the scale was translated into Spanish and its internal consistency, factorial structure and convergent validity were established; and (2) factorial analysis was undertaken to confirm the questionnaire. The results yielded high scores for internal consistency, reliability (α = 0.82; Ω = 0.83) and convergent validity. The examination of the underlying nomological network revealed links with positive and negative feelings, anxiety and aggression. According to the Exploratory Factorial Analysis (EFA), the aggregate variance of the factors in the scale was 65.814%, indicating that they can explain variations in aggression levels in adolescents. For its part, the Factorial Confirmatory Analysis (FCA) confirmed the match between the translation and the model, leading to a sustainable model composed by the three factors identified and eight items: χ2 (17) = 30.693; p < 0.001; χ2/gL = 1.805; CFI = 0.968; NFI = 0.837; TLI = 0.944; RMSEA = 0.060, IC del 95% (0.048−0.072). The short scale is easy to understand and quick to complete and is thus considered a useful instrument to assess aggression levels in adolescents.
Topics: Adolescent; Aggression; Attitude; Humans; Psychometrics; Reproducibility of Results; Surveys and Questionnaires; Translations
PubMed: 35564445
DOI: 10.3390/ijerph19095050 -
Microbiome Research Reports 2022Alterations in the intestinal microbiota are associated with various human diseases of the digestive system, including obesity and its associated metabolic diseases,... (Review)
Review
Alterations in the intestinal microbiota are associated with various human diseases of the digestive system, including obesity and its associated metabolic diseases, inflammatory bowel diseases (IBD), and colorectal cancer (CRC). All three diseases are characterized by modifications of the richness, composition, and metabolic functions of the human intestinal microbiota. Despite being multi-factorial diseases, studies in germ-free animal models have unarguably identified the intestinal microbiota as a causal driver of disease pathogenesis. However, for an increased mechanistic understanding of microbial signatures in human diseases, models require detailed refinement to closely mimic the human microbiota and reflect the complexity and range of dysbiosis observed in patients. The transplantation of human fecal microbiota into animal models represents a powerful tool for studying the causal and functional role of the dysbiotic human microbiome in a pathological context. While human microbiota-associated models were initially employed to study obesity, an increasing number of studies have applied this approach in the context of IBD and CRC over the past decade. In this review, we discuss different approaches that allow the functional validation of the bacterial contribution to human diseases, with emphasis on obesity and its associated metabolic diseases, IBD, and CRC. We discuss the utility of simple models, such as fermentation systems of the human microbiota and intestinal organoids, as well as more complex whole organism models. Our focus here lies on human microbiota-associated mouse models in the context of all three diseases, as well as highlighting the advantages and limitations of this approach.
PubMed: 38046357
DOI: 10.20517/mrr.2022.01 -
European Journal of Orthodontics Jun 2014Factorial designs for clinical trials are often encountered in medical, dental, and orthodontic research. Factorial designs assess two or more interventions... (Review)
Review
Factorial designs for clinical trials are often encountered in medical, dental, and orthodontic research. Factorial designs assess two or more interventions simultaneously and the main advantage of this design is its efficiency in terms of sample size as more than one intervention may be assessed on the same participants. However, the factorial design is efficient only under the assumption of no interaction (no effect modification) between the treatments under investigation and, therefore, this should be considered at the design stage. Conversely, the factorial study design may also be used for the purpose of detecting an interaction between two interventions if the study is powered accordingly. However, a factorial design powered to detect an interaction has no advantage in terms of the required sample size compared to a multi-arm parallel trial for assessing more than one intervention. It is the purpose of this article to highlight the methodological issues that should be considered when planning, analysing, and reporting the simplest form of this design, which is the 2 × 2 factorial design. An example from the field of orthodontics using two parameters (bracket type and wire type) on maxillary incisor torque loss will be utilized in order to explain the design requirements, the advantages and disadvantages of this design, and its application in orthodontic research.
Topics: Humans; Orthodontics; Randomized Controlled Trials as Topic; Research Design; Sample Size
PubMed: 23885023
DOI: 10.1093/ejo/cjt054