Tag: statistics

Implement Sci Commun. 2022 Oct 22;3(1):115. doi: 10.1186/s43058-022-00349-4.

ABSTRACT

BACKGROUND: Contextual fit is an important variable in the implementation of evidence-based programs (EBPs). The objectives of the current study were to examine the psychometric properties of the adapted Self-Assessment of Contextual Fit (SACF) measure for HIV clinical care settings (calling it SACF-HIV) and explore how perceptions of contextual fit varied across two different interventions (an intervention to scale up tailored motivational interviewing and an individually focused HIV prevention intervention) and 12 clinical sites.

METHODS: We collected SACF-HIV data as part of a larger cross-project implementation science study (ATN 153). The study sample includes 128 clinicians, community health workers, interventionists, adherence counselors, and other members of the prevention and care team who engage in the implementation of EBPs at 12 HIV prevention and clinical care sites in the USA. We assessed the internal consistency of the SACF-HIV using Cronbach’s alpha and examined the sub-dimensionality of the scale with an exploratory factor analysis. To explore concurrent validity, we examined Pearson’s correlation coefficients between the adapted scale and fit-related sub-scale scores from the Evidence-Based Practice Attitudes Scale-50 (EBPAS-50). Variation in perceptions of fit by intervention was examined using descriptive statistics.

RESULTS: Internal consistency of the adapted scale was strong (α=0.895). Factor analyses revealed two sub-scales-one capturing general insights regarding contextual fit, such as perceptions of skill, experience, and alignment with client needs (loadings ranging from .5 to .84), and a second centering perceptions regarding implementation support, such as resources and administrative support (loadings ranging from .89 to .97). Concurrent validity was supported by statistically significant correlations in the expected direction with EBPAS-50 fit-related sub-scales (r=.33-.35, p ≤ 0.05). SACF-HIV mean fit scores varied by intervention and the difference was statistically significant (2.78 vs. 2.53, p < 0.05).

CONCLUSIONS: There are relatively few tools assessing perceptions of contextual fit in HIV clinical settings. These results suggest the 12-item adapted SACF is a reliable, valid global assessment of perceptions of contextual fit and implementation support. The SACF-HIV can be used by practitioners and researchers interested in understanding an implementation context when planning to prepare and support EBP implementation.

TRIAL REGISTRATION: TMI ClinicalTrials.gov NCT03681912; YMPH ClinicalTrials.gov NCT03488914.

PMID:36273221 | DOI:10.1186/s43058-022-00349-4

Acta Neuropathol Commun. 2022 Oct 22;10(1):148. doi: 10.1186/s40478-022-01458-w.

ABSTRACT

BACKGROUND: Frontotemporal dementia (FTD) is caused by frontotemporal lobar degeneration (FTLD), characterized mainly by inclusions of Tau (FTLD-Tau) or TAR DNA binding43 (FTLD-TDP) proteins. Plasma biomarkers are strongly needed for specific diagnosis and potential treatment monitoring of FTD. We aimed to identify specific FTD plasma biomarker profiles discriminating FTD from AD and controls, and between FTD pathological subtypes. In addition, we compared plasma results with results in post-mortem frontal cortex of FTD cases to understand the underlying process.

METHODS: Plasma proteins (n = 1303) from pathologically and/or genetically confirmed FTD patients (n = 56; FTLD-Tau n = 16; age = 58.2 ± 6.2; 44% female, FTLD-TDP n = 40; age = 59.8 ± 7.9; 45% female), AD patients (n = 57; age = 65.5 ± 8.0; 39% female), and non-demented controls (n = 148; 61.3 ± 7.9; 41% female) were measured using an aptamer-based proteomic technology (SomaScan). In addition, exploratory analysis in post-mortem frontal brain cortex of FTD (n = 10; FTLD-Tau n = 5; age = 56.2 ± 6.9, 60% female, and FTLD-TDP n = 5; age = 64.0 ± 7.7, 60% female) and non-demented controls (n = 4; age = 61.3 ± 8.1; 75% female) were also performed. Differentially regulated plasma and tissue proteins were identified by global testing adjusting for demographic variables and multiple testing. Logistic lasso regression was used to identify plasma protein panels discriminating FTD from non-demented controls and AD, or FTLD-Tau from FTLD-TDP. Performance of the discriminatory plasma protein panels was based on predictions obtained from bootstrapping with 1000 resampled analysis.

RESULTS: Overall plasma protein expression profiles differed between FTD, AD and controls (6 proteins; p = 0.005), but none of the plasma proteins was specifically associated to FTD. The overall tissue protein expression profile differed between FTD and controls (7-proteins; p = 0.003). There was no difference in overall plasma or tissue expression profile between FTD subtypes. Regression analysis revealed a panel of 12-plasma proteins discriminating FTD from AD with high accuracy (AUC: 0.99). No plasma protein panels discriminating FTD from controls or FTD pathological subtypes were identified.

CONCLUSIONS: We identified a promising plasma protein panel as a minimally-invasive tool to aid in the differential diagnosis of FTD from AD, which was primarily associated to AD pathophysiology. The lack of plasma profiles specifically associated to FTD or its pathological subtypes might be explained by FTD heterogeneity, calling for FTD studies using large and well-characterize cohorts.

PMID:36273219 | DOI:10.1186/s40478-022-01458-w

Res Involv Engagem. 2022 Oct 22;8(1):57. doi: 10.1186/s40900-022-00393-3.

ABSTRACT

BACKGROUND: Youth violence is a global public health issue and the highest rates are reported in Low and Middle-Income Countries (LMICs). Higher rates of youth violence are reported in Sri Lanka as well. Students who fail to continue higher studies in schools or enter the universities in Sri Lanka, enroll in technical colleges and are associated with a higher number of risk factors of violence. This study aims to empower youth (15-29 years old) of a technical college in Matale district, Sri Lanka, to carry out activities among themselves to improve their knowledge, change perceptions, and violence-related behaviours.

METHODS: The Participatory Action Research (PAR) approach will be used. The study participants will be eighty students in a technical college in Matale district, Sri Lanka. The study period will be three years. Study participants will also be collaborators and they will involve actively in all stages of the study. A health promotion intervention will be implemented to identify determinants of youth violence and to design and implement actions while monitoring the changes. The data will be collected mainly through focus group discussions and key informant interviews both before and after the health promotion intervention. Additionally, a self-administered questionnaire will be used and the principal investigator will maintain a reflective diary. The qualitative data will be analysed thematically whereas quantitative data will be analysed using descriptive statistics. Data will be triangulated to increase the rigour of the study.

DISCUSSION: According to literature, PAR is not widely used in health promotion. The enabling and empowerment goals of health promotion are fulfilled in PAR. Thus, this will be a novel experience for researchers and this will stimulate discussion on the combination of PAR and health promotion. This study design itself promotes active participant involvement and it may generate effective youth-led, culturally appropriate actions to address youth violence. The findings will describe what works and why it works and will help Sri Lanka and similar LMICs to create safe environments for youth in educational institutes or training colleges.

PMID:36273215 | DOI:10.1186/s40900-022-00393-3

BMC Res Notes. 2022 Oct 22;15(1):328. doi: 10.1186/s13104-022-06204-y.

ABSTRACT

OBJECTIVE: Obesity and mediators of inflammation have been identified as the most important risk and predictive factors in postmenopausal breast cancer (BC) survivors using aromatase inhibitors (AIs). This study was conducted to assess the impact of point of care technology (PCOT) as part of pathology supported genetic testing (PSGT) to prevent BC therapy-associated comorbidities in African settings.

RESULTS: The study revealed that high sensitivity C-reactive protein (hs-CRP) and body mass index (BMI) are predictors of cardiovascular (CVD) related adverse events in obese postmenopausal patients subjected to AIs. There were statistically significant variations in total body fat (TBF), weight, hs-CRP, body mass index (BMI), homocysteine, ferritin, and calcium between baseline and after 24 months of follow-up. The above inflammatory markers can be incorporated in pathology supported genetic testing (PSGT) using HyBeacon® probe technology at POC for prediction and management of AI-associated adverse events among postmenopausal breast cancer survivors and associated comorbidities. The barriers for implementation of POCT application among six African countries for diagnosis of breast cancer were documented as insufficient of BC diagnosis and management capacity at different levels of health system.

PMID:36273209 | DOI:10.1186/s13104-022-06204-y

BMC Rheumatol. 2022 Oct 22;6(1):83. doi: 10.1186/s41927-022-00311-w.

ABSTRACT

BACKGROUND: Rheuma Tolerance for Cure (RTCure) is a five-year international collaboration between academia, industry and patients/members of the public. It focuses on developing approaches to predict the onset of rheumatoid arthritis (RA) and designing clinical trials to reduce the risk of disease development through immune-tolerising and other treatments. We conducted a mid-term evaluation of patient and public involvement (PPI) within the project.

METHODS: Two surveys on PPI were co-designed by the PPI Coordinator, Patient/Public Research Partners (PRPs) and a researcher. Both anonymous, electronic surveys were distributed to 61 researchers and 9 PRPs. Quantitative survey data were analysed using descriptive statistics and free text responses underwent inductive thematic analysis.

RESULTS: Researcher and Patient response rates were 33% and 78%, respectively. Quantitative Researcher Survey data highlighted that (i) responding researchers represented all seven Work Packages (WPs), (ii) 40% thought PRPs had made a large or extremely large contribution to their own WPs, (iii) 55% thought PPI has had a moderate or large impact on RTCure, (iv) 75% worked with PRPs in RTCure, and (v) 60% said PRPs had affected their research thinking. Quantitative PRP Survey data highlighted that (i) PRPs were most involved in four WPs, (ii) 43% thought they had made a minor contribution to their main WP, (iii) 57% thought PPI has had a small impact on RTCure, and (iv) 57% thought they received too little feedback on the outcome of their contribution to different tasks. Four main themes were identified in both surveys: ‘PRP contributions’, ‘Experiences of PPI’, ‘Impact of PPI on RTCure’, and ‘How PPI can be improved’. Two additional themes from the Researcher Survey were ‘Impact of PPI on researchers’ and ‘Influence on Future Projects’, and from the PRP Survey were ‘Impact of PPI on PRPs’ and ‘Engagement with PRPs’.

CONCLUSION: PPI seemed to have a significant impact on RTCure, however, PRPs were less aware. A focus on improving communication between PRPs and researchers (facilitated by the PPI Coordinator), and providing PPI training for researchers is likely to improve involvement. Complex legal agreements for PRPs should be avoided and careful attention paid to appropriate PRP compensation.

PMID:36273206 | DOI:10.1186/s41927-022-00311-w

Nat Commun. 2022 Oct 22;13(1):6302. doi: 10.1038/s41467-022-33580-7.

ABSTRACT

Viewing faces that are perceived as emotionally expressive evokes enhanced neural responses in multiple brain regions, a phenomenon thought to depend critically on the amygdala. This emotion-related modulation is evident even in primary visual cortex (V1), providing a potential neural substrate by which emotionally salient stimuli can affect perception. How does emotional valence information, computed in the amygdala, reach V1? Here we use high-resolution functional MRI to investigate the layer profile and retinotopic distribution of neural activity specific to emotional facial expressions. Across three experiments, human participants viewed centrally presented face stimuli varying in emotional expression and performed a gender judgment task. We found that facial valence sensitivity was evident only in superficial cortical layers and was not restricted to the retinotopic location of the stimuli, consistent with diffuse feedback-like projections from the amygdala. Together, our results provide a feedback mechanism by which the amygdala directly modulates activity at the earliest stage of visual processing.

PMID:36273204 | DOI:10.1038/s41467-022-33580-7

J Pharm Policy Pract. 2022 Oct 22;15(1):69. doi: 10.1186/s40545-022-00464-6.

ABSTRACT

BACKGROUND: Competitive tenders on pharmaceuticals are one of the most effective cost-containment instruments in healthcare systems. Its effectiveness has been demonstrated, among other things, in markets for generic medicine and biosimilars. In Denmark, an internationally unique model for competitive tenders on analogue substitutable pharmaceuticals has been developed and implemented for all public hospitals.

METHODS: We obtained data on all analogue competitive tenders carried out by the Danish Medicines Council from its foundation on January 1, 2017, to October 9, 2020. We calculated univariate descriptive statistics, pairwise correlations and made a multiple regression analysis on tender savings.

RESULTS: Average annual saving on hospital pharmaceutical purchase prices was 44.1% ranging from 0.4% to 92.8% between therapeutic areas and areas of indication. There was a significant positive correlation between tender savings and the number of competitors participating in the tender, and a significant negative correlation between tender savings and the number of days since market authorization.

CONCLUSIONS: This study finds analogue tenders to be similar in effect and mechanism to competitive tenders in markets for generic medicine and biosimilars. It supports the increasing number of empirical findings that competitive tendering has a high potential to generate substantial savings on healthcare budgets.

PMID:36273196 | DOI:10.1186/s40545-022-00464-6

Trials. 2022 Oct 22;23(1):886. doi: 10.1186/s13063-022-06800-0.

ABSTRACT

BACKGROUND: Aboriginal Australians are known to suffer high levels of acquired brain injury (stroke and traumatic brain injury) yet experience significant barriers in accessing rehabilitation services. The aim of the Healing Right Way trial is to evaluate a culturally secure intervention for Aboriginal people with newly acquired brain injury to improve their rehabilitation experience and quality of life. Following publication of the trial protocol, this paper outlines the statistical analysis plan prior to locking the database. METHODS: The trial involves a stepped wedge design with four steps over 3 years. Participants were 108 adult Aboriginal Australians admitted to one of eight hospitals (four rural, four urban) in Western Australia within 6 weeks of onset of a new stroke or traumatic brain injury who consented to follow-up for 26 weeks. All hospital sites started in a control phase, with the intervention assigned to pairs of sites (one metropolitan, one rural) every 26 weeks until all sites received the intervention. The two-component intervention involves training in culturally safe care for hospital sites and enhanced support provided to participants by Aboriginal Brain Injury Coordinators during their hospital stay and after discharge. The primary outcome is quality of life as measured by the Euro QOL-5D-3L VAS. A mixed effects linear regression model will be used to assess the between-group difference at 26 weeks post-injury. The model will control for injury type and severity, age at recruitment and time since commencement of the trial, as fixed effects. Recruitment site and participant will be included as random effects. Secondary outcomes include measurements of function, independence, anxiety and depression, carer strain, allied health occasions of service received and hospital compliance with minimum processes of care based on clinical guidelines and best practice models of care.

DISCUSSION: The trial will provide the first data surrounding the effectiveness of an intervention package for Aboriginal people with brain injury and inform future planning of rehabilitation services for this population. The statistical analysis plan outlines the analyses to be undertaken.

TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12618000139279. Registered 30 January, 2018.

PMID:36273182 | DOI:10.1186/s13063-022-06800-0

Trials. 2022 Oct 22;23(1):889. doi: 10.1186/s13063-022-06796-7.

ABSTRACT

BACKGROUND: Randomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions on outcomes. Here, we present a protocol for a simulation study investigating the consequences of different levels of interactions between the trial interventions on outcomes for the future 2×2×2 factorial designed randomised clinical Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial in comatose patients after out-of-hospital cardiac arrest.

METHODS: By simulating a multisite trial with 50 sites and 3278 participants, and a presumed six-month all-cause mortality of 60% in the control population, we will investigate the validity of the trial results with different levels of interaction effects on the outcome. The primary simulation outcome of the study is the risks of type-1 and type-2 errors in the simulated scenarios, i.e. at what level of interaction is the desired alpha and beta level exceeded. When keeping the overall risk of type-1 errors ≤ 5% and the risk of type-2 errors ≤ 10%, we will quantify the maximum interaction effect we can accept if the planned sample size is increased by 5% to take into account possible interaction between the trial interventions. Secondly, we will assess how interaction effects influence the minimal detectable difference we may confirm or reject to take into account 5% (small interaction effect), 10% (moderate), or 15% (large) positive interactions in simulations with no ‘true’ intervention effect (type-1 errors) and small (5%), moderate (10%), or large negative interactions (15%) in simulations with ‘true’ intervention effects (type-2 errors). Moreover, we will investigate how much the sample size must be increased to account for a small, moderate, or large interaction effects.

DISCUSSION: This protocol for a simulation study will inform the design of a 2×2×2 factorial randomised clinical trial of how potential interactions between the assessed interventions might affect conclusions. Protocolising this simulation study is important to ensure valid and unbiased results.

TRIAL REGISTRATION: Not relevant.

PMID:36273179 | DOI:10.1186/s13063-022-06796-7

J Ultrasound. 2022 Oct 22. doi: 10.1007/s40477-022-00735-7. Online ahead of print.

ABSTRACT

AIM: We aimed to evaluate the effectiveness of combining 2-dimensional shear wave elastography (2D-SWE) with ultrasonography (US) in diagnosing acute appendicitis in patients with suspected acute appendicitis.

METHODS: Clinical and laboratory findings, gray-scale US and 2D-SWE imaging features, operation information, and pathology results of 48 patients diagnosed with acute appendicitis who presented with right lower quadrant pain were prospectively evaluated. We compared the findings to the US and SWE imaging features of 79 asymptomatic patients.

RESULTS: Mean Alvarado score and appendix diameter were statistically significantly higher for acute appendicitis (p < 0.001). In patients with acute appendicitis, mesenteric lymphadenopathy and fat stranding were also more frequent (p < 0.001). The mean velocity and kPa values for appendix and mesenteric fat were statistically significantly higher in acute appendicitis (p < 0.001).

CONCLUSION: In the diagnosis of acute appendicitis, 2D-SWE increases the diagnostic performance of gray-scale US in the differentiation of inflamed and normal appendixes.

PMID:36273062 | DOI:10.1007/s40477-022-00735-7