Tag: statistics

PLoS One. 2022 May 24;17(5):e0268898. doi: 10.1371/journal.pone.0268898. eCollection 2022.

ABSTRACT

INTRODUCTION: Complete and understandable information is vital for informed consent and this includes how and when potential participants can expect to receive trial results. Informing participants during informed consent about the sharing of trial results is important for addressing participants’ needs, ensuring adherence to regulatory guidance, and in fulfilling a moral obligation.

METHODS: Patient Information Leaflets (PILs) were collated from across the UK and Ireland. Trial characteristics and data on disseminating trial results was extracted. Analysis included descriptive statistics and a directed content analysis approach. The content analysis framework was informed by regulatory guidance on PIL content and existing research on dissemination of trial results. Results were analysed using descriptive statistics and presented as a narrative summary as appropriate.

RESULTS: 238 PILs from 178 trials were analysed. Of the 238 PILs, 74% (n = 176) provided information on sharing results with participants, 70% (n = 123) of which described passive methods of disseminating results that require active engagement from the trial participants, i.e., effort required by the participant to seek the results. The majority (90%) of PILs included more than one proposed mode of dissemination that largely targeted healthcare professionals rather than participants. Only 8% of PILs specified a time period for when results could be expected, 47% did not specify a time period (e.g. at end of trial), and 45% included no information on when trial results would be available.

CONCLUSION: This study found that majority of the PILs included did include some information about dissemination of trial results. However, modes of dissemination tended to target researchers and clinicians rather than participants and information on when results would be available was often lacking. The findings highlight the need for further research that includes stakeholder input to identify what information on results summaries participants need at the point of making a decision about trial participation.

PMID:35609047 | DOI:10.1371/journal.pone.0268898

PLoS One. 2022 May 24;17(5):e0267655. doi: 10.1371/journal.pone.0267655. eCollection 2022.

ABSTRACT

Hyperglycaemia is a major risk factor in critically ill patients leading to adverse outcomes and mortality in diabetic and non-diabetic patients. The target blood glucose remained controversial; this study aimed to contribute in assessing the practice of hyperglycaemia control in intensive care units of the Military Hospital. Furthermore, the study proposed a protocol for hyperglycaemia control based on findings. A hospital-based cross-sectional study assessed the awareness and practice towards hyperglycaemia management in a sample 83 healthcare staff selected through stratified random sampling technique. In addition, 55 patients were enrolled, through quota sampling, after excluding those with diabetic ketoacidosis, hyperosmolar-hyperglycaemic state and patients < 18 years. A self-administrated questionnaire enabled to collect data from health staff and patient data were extracted from the medical records. SPSS-23 was used to analyze the collected data. Chi-square and ANOVA tests assessed the association among variables, these tests were considered statistically significant when p ≤ 0.05. The training on hyperglycaemia control differed (p = 0.017) between doctors and nurses. The target glycaemic level (140-180 mg/dl) was known by 11.1% of the study participants. Neither the knowledge nor the practice of hyperglycaemia control methods differed among staff (p> 0.05). The use of sliding scale was prevalent (79.3%) across the ICUs (p = 0.002). 31.5% of the patients had received different glycaemic control methods, 11.8% were in the targeted blood glucose level. Sliding scale was the method used by doctors and nurses (71.4% and 81.6% respectively). Lack of awareness about hyperglycaemia management methods was prevalent among ICU healthcare staff. Use of obsolete methods was the common practice in the ICUS of the Military Hospital. Target blood glucose for patients were unmet. Development of a local protocol for glycaemic control in all ICUs is needed along with sustained training programs on hyperglycaemia control for ICU healthcare staff.

PMID:35609030 | DOI:10.1371/journal.pone.0267655

PLoS One. 2022 May 24;17(5):e0268096. doi: 10.1371/journal.pone.0268096. eCollection 2022.

ABSTRACT

BACKGROUND: High-quality general practice has been demonstrated to provide cost-effective, equitable health care and improve health outcomes. Yet there is currently not a set of agreed comprehensive indicators in Australia. We have developed 79 evidence-based indicators and their corresponding 129 measures of high-quality general practice. This study aims to achieve consensus on relevant and feasible indicators and measures for the Australian context.

METHODS: This Delphi consensus study, approved by WSU Human Research Ethics Committee, consists of three rounds of online survey with general practice experts including general practitioners, practice nurses and primary health network staff. The identified indicators and measures are grouped under an attribute framework aligned with the Quadruple Aim, and further grouped under structures, processes and outcomes according to the Donabedian framework. Participants will rate each indicator and measure for relevance and feasibility, and provide comments and recommendations of additional indicators or measures. In the last round, participants will also be asked their views on the implementation of a quality indicator tool. Each indicator and measure will require ≥70% agreement in both relevance and feasibility to achieve consensus. Aggregated ratings will be statistically analysed for response rates, level of agreement, medians, interquartile ranges and group rankings. Qualitative responses will be analysed thematically using a mixed inductive and deductive approach.

DISCUSSION: This protocol will add to the current knowledge of the translation of performance guidelines into quality practice across complex clinical settings and in a variety of different contexts in Australian general practice. The Delphi technique is appropriate to develop consensus between the diverse experts because of its ability to offer anonymity to other participants and minimise bias. Findings will contribute to the design of an assessment tool of high-quality general practice that would enable future primary health care reforms in Australia.

PMID:35609025 | DOI:10.1371/journal.pone.0268096

J Phys Chem B. 2022 May 24. doi: 10.1021/acs.jpcb.2c01927. Online ahead of print.

ABSTRACT

We present a model that explains variance in the thermodiffusion of hydrocarbon isomers in binary liquid mixtures. The model relies on material transport equations for binary nonisothermal liquid systems that were derived through a nonequilibrium thermodynamic approach in a previous work, coupled with one of two methods: (i) use of equilibrium chemical potentials for each component under conditions of constant pressure, derived using statistical mechanics or (ii) use of the temperature derivative of chemical potential expressed phenomenologically as molecular entropy. The model is evaluated using Soret coefficients (S_T) measured in binary solutions of heptane isomers in benzene. The statistical mechanic approach yields moderately acceptable agreement with experimental data. The phenomenological approach, which relies on both measured and calculated values of molecular entropy from the literature, yields values of S_T centered around the experimental data, with the scatter likely due to poor precision in the measured or calculated values of entropy. For the latter case, we identify several methods for calculating entropy that yield good agreement with experimental data.

PMID:35608999 | DOI:10.1021/acs.jpcb.2c01927

Appl Spectrosc. 2022 May 24:37028221092789. doi: 10.1177/00037028221092789. Online ahead of print.

ABSTRACT

Five species of bacteria including Escherichia coli, Mycobacterium smegmatis, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Enterobacter cloacae were deposited from suspensions of various titers onto disposable nitrocellulose filter media for analysis by laser-induced breakdown spectroscopy (LIBS). Bacteria were concentrated and isolated in the center of the filter media during centrifugation using a simple and convenient sample preparation step. Summing all the single-shot LIBS spectra acquired from a given bacterial deposition provided perfectly sensitive and specific discrimination from sterile water control specimens in a partial least squares discriminant analysis (PLS-DA). Use of the single-shot spectra provided only a 0.87 and 0.72 sensitivity and specificity, respectively. To increase the statistical validity of chemometric analyses, a library of pseudodata was created by adding Gaussian noise to the measured intensity of every emission line in an averaged spectrum of each bacterium. The normally distributed pseudodata, consisting of 4995 spectra, were used to compare the performance of the PLS-DA with a discriminant function analysis (DFA) and an artificial neural network (ANN). For the highly similar bacterial data, no algorithm showed significantly superior performance, although the PLS-DA performed least accurately with a classification error of 0.21 compared to 0.16 and 0.17 for ANN and DFA, respectively. Single-shot LIBS spectra from all of the bacterial species were classified in a DFA model tested with a tenfold cross-validation. Classification errors ranging from 20% to 31% were measured due to repeatability limitations in the single-shot data.

PMID:35608993 | DOI:10.1177/00037028221092789

Ethn Health. 2022 May 24:1-24. doi: 10.1080/13557858.2022.2078482. Online ahead of print.

ABSTRACT

OBJECTIVES: Obesity and its sequelae are an increasing problem, disproportionally affecting Māori and Pacific peoples, secondary to multifactorial systemic causes, including the effects of colonisation and the impact of globalisation. There is limited synthesised evidence on interventions to address obesity in these populations. The objective of this review is to identify evaluated interventions for prevention and management of obesity amongst Māori and Pacific adults, assess the effectiveness of these interventions, and identify enablers and barriers to their uptake.

DESIGN: Systematic review of databases (Medline, PubMed, EMBASE, CINAHL, Scopus, CENTRAL), key non-indexed journals, and reference lists of included articles were searched from inception to June 2021. Eligibility criteria defined using a Population, Intervention, Control, Outcome format and study/publication characteristics. Quantitative and qualitative data were extracted and analysed using narrative syntheses. Study quality was assessed using modified GRADE approach.

RESULTS: From the 8190 articles identified, 21 were included, with 18 eligible for quantitative and five for qualitative analysis. The studies were heterogenous, with most graded as low quality. Some studies reported small but statistically significant improvements in weight and body mass index. Key enablers identified were social connection, making achievable sustainable lifestyle changes, culturally-centred interventions and incentives including money and enjoyment. Barriers to intervention uptake included difficulty in maintaining adherence to a programme due to intrinsic programme factors such as lack of social support and malfunctioning or lost equipment.

CONCLUSIONS: Normal weight trajectory is progressive increase over time. Modest weight loss or no weight gain after several years may have a positive outcome in lowering progression to diabetes, or improvement of glycaemic control in people with diabetes. We recommend urgent implementation of Māori and Pacific-led, culturally-tailored weight loss programmes that promote holistic, small and sustainable lifestyle changes delivered in socially appropriate contexts.

PMID:35608909 | DOI:10.1080/13557858.2022.2078482

Otolaryngol Head Neck Surg. 2022 May 24:1945998221097659. doi: 10.1177/01945998221097659. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare findings of same-day cine magnetic resonance imaging (MRI) and drug-induced sleep endoscopy (DISE) and examine how each technique uniquely contributes to the evaluation of persistent obstructive sleep apnea following adenotonsillectomy.

STUDY DESIGN: Retrospective cohort study.

SETTING: Quaternary care center.

METHODS: Chart review was performed for consecutive patients who underwent same-day cine MRI and DISE between 2015 and 2020. Descriptive statistics are reported, and Cohen kappa coefficients were calculated to evaluate the agreement between cine MRI and DISE for obstruction at the adenoids, lingual tonsils, and tongue base.

RESULTS: There were 137 patients, the mean age was 10.4 years (95% CI, 3.2-16.7), and 62.8% were male. The most common sites of obstruction on DISE were the tongue base (86.9%), velum (78.7%), epiglottis (74.5%), inferior turbinate (68.6%), and lingual tonsil (61.3%). The most common sites of obstruction on cine MRI were the hypopharynx (56.3%), tongue base (44.8%), lingual tonsil (38.0%), and macroglossia (37.6%). There was moderate agreement for adenoid hypertrophy (κ = 0.53) and poor agreement for lingual tonsil hypertrophy (κ = 0.15) and tongue base obstruction (κ = 0.09). DISE identified more instances of multilevel obstruction when compared with cine MRI (94.9% vs 48.2%).

CONCLUSION: DISE offered a better examination of nasal and supraglottic obstruction and is sensitive to partial vs complete collapse, while cine MRI offered better soft tissue resolution for lymphoid tissue hypertrophy and provided a global view of primary and secondary airway obstruction. Cine MRI and DISE are complementary modalities in the evaluation of children with persistent obstructive sleep apnea.

PMID:35608914 | DOI:10.1177/01945998221097659

Elife. 2022 May 24;11:e78793. doi: 10.7554/eLife.78793. Online ahead of print.

ABSTRACT

Neurogenesis is the generation of neurons from stem cells, a process that is regulated by SoxB transcription factors (TFs) in many animals. Although the roles of these TFs are well understood in bilaterians, how their neural function evolved is unclear. Here, we use Hydractinia symbiolongicarpus, a member of the early-branching phylum Cnidaria, to provide insight into this question. Using a combination of mRNA in situ hybridization, transgenesis, gene knockdown, transcriptomics, and in-vivo imaging, we provide a comprehensive molecular and cellular analysis of neurogenesis during embryogenesis, homeostasis, and regeneration in this animal. We show that SoxB genes act sequentially at least in some cases. Stem cells expressing Piwi1 and Soxb1, which have a broad developmental potential, become neural progenitors that express Soxb2 before differentiating into mature neural cells. Knockdown of SoxB genes resulted in complex defects in embryonic neurogenesis. Hydractinia neural cells differentiate while migrating from the aboral to the oral end of the animal, but it is unclear whether migration per se or exposure to different microenvironments is the main driver of their fate determination. Our data constitute a rich resource for studies aiming at addressing this question, which is at the heart of understanding the origin and development of animal nervous systems.

PMID:35608899 | DOI:10.7554/eLife.78793

Intern Med J. 2022 May 24. doi: 10.1111/imj.15827. Online ahead of print.

ABSTRACT

BACKGROUND: COVID-19 has caused a global shift in healthcare seeking behaviour, however, presentation rates with serious conditions such as stroke in low COVID-19 prevalence cities has received less attention.

AIMS: To determine if there was a significant reduction in stroke admissions, delivery of acute reperfusion therapies, or increased delays to presentation during the first wave of the COVID-19 pandemic.

METHODS: A multicentre, retrospective, observational cohort study was performed across three tertiary hospitals in Brisbane, Australia. Cases were identified using ICD-10 codes and then individually reviewed for eligibility using prespecified inclusion and exclusion criteria. All metrics were compared over three months from March 1 to May 31, 2020 with two corresponding 3-month periods in 2018 and 2019.

RESULTS: There was a mean of 2.15 (95% CI 1.87-2.48) stroke admissions per day in the examined pandemic months compared to 2.13 (95% CI 1.85-2.45) and 2.26 (95% CI 1.97-2.59) in March to May 2018 and 2019 respectively, with no significant difference found (p = 0.81). There was also no difference in rates of intravenous thrombolysis (p = 0.82), endovascular thrombectomy (p = 0.93) and time from last known well to presentation (p = 0.54). Conversely, daily emergency department presentations (including non-stroke presentations) significantly reduced (p < 0.0001).

CONCLUSIONS: During the early months of the COVID-19 pandemic there was no significant reduction in stroke presentations, use of acute reperfusion therapies or delays to presentation, despite a reduction in ED presentations for any cause. Our results differ from the global experience, with possible explanations including differences in public health messaging and healthcare infrastructure. This article is protected by copyright. All rights reserved.

PMID:35608890 | DOI:10.1111/imj.15827

JMIR Diabetes. 2022 May 24;7(2):e31832. doi: 10.2196/31832.

ABSTRACT

BACKGROUND: The use of digital technology to assess patients remotely can reduce clinical study costs. In the European Union, the 2D matrix code on prescription drug packaging serves as a unique identifier of a given package of medication, and thus, also of the patient receiving that medication. Scanning of the 2D matrix code may therefore allow remote patient authentication in clinical studies.

OBJECTIVE: The aim of the DePRO study was to assess the feasibility of a fully digital data-capture workflow, the authentication of participants via drug packaging 2D matrix codes, in patients with type 2 diabetes mellitus (T2DM) who use metformin. The primary objective was to describe the self-care activities of these patients. Secondary objectives were to evaluate (1) the self-reported health status of these patients, (2) the association of self-care activities with demographics and disease characteristics, and (3) the usability of the my ePRO app.

METHODS: DePRO was an observational, multicenter, cross-sectional, digital, and patient-driven study conducted in Germany from June to December 2020. Adult patients prescribed metformin were invited to participate via their pharmacist or a medication tracker app. Participants downloaded the my ePRO app onto their own mobile device, scanned the 2D matrix code on their metformin package for registration and authentication, and provided informed consent via an electronic form. They were then able to complete a study-specific questionnaire on demographics and clinical characteristics, the German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G), the Diabetes Treatment Satisfaction Questionnaire (DTSQ), and the EQ-5D-5L. The patients conducted the study without support from a health care professional. Statistical analyses were exploratory and descriptive.

RESULTS: In total, 3219 patients were invited to participate. The proportion of patients giving consent was greater among those invited by pharmacists (19/217, 8.8%) than among those invited via the medication tracker app (13/3002, 0.4%). Of the 29 patients eligible for analysis, 28 (97%) completed all study questionnaires. Most of the patients (23/29, 79%) were aged <60 years, and 59% (17/29) were male. The patients spent a mean total of 3.5 (SD 1.3) days out of 7 days on self-care activities (SDSCA-G). Most patients (24/29, 83%) were satisfied to extremely satisfied with their current treatment (DTSQ). Events of perceived hyperglycemia or hypoglycemia were reported by 20 of 29 (69%) patients. The best possible health status (EQ-5D-5L) was reported by 18 of 28 (64%) patients. Age was positively correlated with time spent on general and specific diet (Spearman coefficient 0.390 and 0.434, respectively).

CONCLUSIONS: The DePRO study demonstrates the feasibility of fully digital authentication (via 2D matrix codes on drug packaging) and data capture in patients with T2DM. Personal invitations yielded higher recruitment rates than remote invitations via the medication tracker app. A high questionnaire completion rate was realized, based on completion by 28 out of 29 patients.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/21727.

PMID:35608887 | DOI:10.2196/31832