Category: Statistics

Cornea. 2023 Dec 20. doi: 10.1097/ICO.0000000000003457. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to describe the effects of intracameral air on corneal edema.

METHODS: A laboratory investigation was performed on human donor corneas. Baseline pachymetry measurements through anterior segment optical coherence tomography and endothelial cell density were obtained for all corneas. Each pair of corneas was separated and randomly assigned to undergo air injection or Optisol-GS into a BIONIKO artificial anterior chamber for 5 minutes at physiologic intraocular pressure confirmed by digital palpation. Photographs were obtained immediately on connection of the cornea to the artificial anterior chamber and on completion of the 5 minutes of treatment, with anterior chamber air being exchanged for Optisol-GS. Pretreatment and posttreatment photographs were obtained. Immediately after treatment, pachymetry was again obtained on all corneas. Pachymetry data underwent statistical analysis.

RESULTS: Corneal pachymetry improved from 690.5 ± 126.6 to 576.1 ± 87.2 μm, yielding a 114.4 ± 50.4 μm improvement of pachymetry in the group with air injected into the anterior chamber. This was a significant improvement of pachymetry when compared with the group with Optisol-GS injected into the anterior chamber, which showed an improvement from 662.3 ± 126.5 to 613.5 ± 108.0 μm, yielding an improvement of 48.8 ± 34.3 μm.

CONCLUSIONS: Injection of air into the anterior chamber leads to a significant decrease in corneal pachymetry. We thereby propose that injecting air intracamerally is an effective intraoperative intervention when visualization is negatively affected by corneal edema.

PMID:38128101 | DOI:10.1097/ICO.0000000000003457

Australas Psychiatry. 2023 Dec 21:10398562231222815. doi: 10.1177/10398562231222815. Online ahead of print.

ABSTRACT

OBJECTIVE: Black humour permits expression of what may otherwise be unspeakable and is observed and used by staff working in mental health services. The aim of this study was to identify how humour, particularly black humour, was perceived by different health professionals in psychiatric practice.

METHODS: Participants were invited to complete a survey. Data was collated and statistically analysed by a biostatistician. Chi square and univariate tests were performed to identify associations between categories.

RESULTS: The sub-question relating to the benefits of black humour was analysed. Main findings were that the majority of staff perceived black humour to be beneficial in psychiatric practice (n = 564 of 710 total; 79.4%), particularly if they used general and black humour with patients, families and colleagues. Those who observed black humour being used collegially about patients and families were more likely to find black humour beneficial; and even those uncomfortable with black humour being used by colleagues were more likely to see the benefits of black humour.

CONCLUSION: Black humour was perceived to be beneficial in mental health settings when used mindfully, sensitively and in context. Further study with patients and relatives may shed light on how widely the perception of benefit is shared.

PMID:38128076 | DOI:10.1177/10398562231222815

J Nurs Res. 2023 Dec 22. doi: 10.1097/jnr.0000000000000588. Online ahead of print.

ABSTRACT

BACKGROUND: Electronic health (eHealth) literacy is a relatively new concept used to determine health outcomes. However, it is not well known how eHealth literacy relates to health outcomes such as diabetes self-management.

PURPOSE: This study was designed to examine the relationships among eHealth literacy, self-efficacy, social support, and self-management in people with Type 2 diabetes.

METHODS: A cross-sectional design was used to examine secondary data from a field survey of people with Type 2 diabetes recruited from outpatient clinics from August to December 2021 (N = 453). A structural equation model was used that first analyzed the measurement model using confirmatory factor analysis and then tested the hypothesized structural model to estimate the expected relationships among the study variables. The significance of the statistical estimates for the model was assessed based on the 95% bias-corrected bootstrap confidence interval from 5,000 bootstrap resamples.

RESULTS: Significant, indirect relationships were found between eHealth literacy and self-management via self-efficacy (β = 0.26, B = 0.17, 95% CI [0.10, 0.24]) and via social support and, in turn, self-efficacy (β = 0.08, B = 0.05, 95% CI [0.04, 0.08]). eHealth literacy, social support, and self-efficacy together explained 58.1% of the variance in self-management.

CONCLUSION/IMPLICATIONS FOR PRACTICE: This study provides new evidence regarding how eHealth literacy relates to self-management in people with Type 2 diabetes via two indirect pathways, including self-efficacy alone and social support and self-efficacy in series. An eHealth literacy program for self-management should be developed in clinical practice that includes strategies for inducing synergistic effects from self-efficacy and social support on self-management in people with Type 2 diabetes.

PMID:38128065 | DOI:10.1097/jnr.0000000000000588

Eur J Neurosci. 2023 Dec 21. doi: 10.1111/ejn.16211. Online ahead of print.

ABSTRACT

Children with cerebral palsy (CP) exhibit impaired motor control and significant muscle weakness due to a brain lesion. However, studies that assess the relationship between brain activity and performance on dynamic functional muscle strength assessments in CP are needed. The aim of this study was to determine the effect of a progressive lateral step-up test on prefrontal cortex (PFC) hemodynamic activity in children with CP. Fourteen ambulatory children with spastic CP (Gross Motor Function Classification System level I; 5-11 y) and 14 age- and sex-matched typically developing control children completed a progressive lateral step-up test at incremental step heights (0, 10, 15 and 20 cm) using their non-dominant lower limb. Hemodynamic activity in the PFC was assessed using non-invasive, portable functional neuroimaging (functional near-infrared spectroscopy). Children with CP completed fewer repetitions at each step height and exhibited lower PFC hemodynamic activity across step heights compared to controls. Lower PFC activation in CP was maintained after statistically controlling for the number of repetitions completed at each step height. PFC hemodynamic activity was not associated with LSUT task performance in children with CP, but a positive relationship was observed in controls at the most challenging 20 cm step height. The results suggest there is an altered PFC recruitment pattern in children with CP during a highly dynamic test of functional strength. Further studies are needed to explore the mechanisms underlying the suppressed PFC activation observed in children with CP compared to typically developing children.

PMID:38128061 | DOI:10.1111/ejn.16211

PLoS One. 2023 Dec 21;18(12):e0296135. doi: 10.1371/journal.pone.0296135. eCollection 2023.

ABSTRACT

Catches from the small-scale trap fishery in Bandon Bay, Suratthani, Thailand, were monitored from 14 sites around the Bay, then disturbance to aquatic communities and catch assemblage were examined. At the same time, the hydrographical features of the bay were surveyed. The study was conducted throughout 2019 except in December, when a tropical cyclone made sampling impossible. In total, 17,373 animals from 118 species or species groups of aquatic animals were collected. The main target of the fishery, blue swimming crab Portunus pelagicus, contributed about 10% of the total catch in terms of number; meanwhile, another crab, Charybdis affinis, was the most dominant species (41% of total). W-statistics of Abundance-Biomass Comparison curves ranged between -0.025 and 0.031, indicating light disturbance to the communities in this fishing ground. The catch assemblage, based on number in catch composition, were divided into three main clusters and six sub-clusters by using the self-organizing map (SOM) technique. The SOM results showed that the catch assemblages differed based largely on temporal variation. The hydrographic features of Bandon Bay at times exhibited a layered structure and had strong spatial variation. The bay’s current system was governed by motion of tidal currents; meanwhile, the circulation was governed by monsoonal wind and freshwater discharges. Tidal current was strong and ranged between approximately 0.6 m to 2.2 m. Water within the bay was always warmer than the outer sea. High water temperature was observed two times during the year: during monsoon transition 1 (April to May) and transition 2 (October). Salinity showed great spatial and temporal variation, differing by more than 5-10 ppt horizontally. It was possible to use these dynamic hydrological features of Bandon Bay to explain assemblage patterns of the trap-net catches.

PMID:38128060 | DOI:10.1371/journal.pone.0296135

PLoS One. 2023 Dec 21;18(12):e0296076. doi: 10.1371/journal.pone.0296076. eCollection 2023.

ABSTRACT

BACKGROUND: Stillbirths are indicators of the quality of obstetrics care in health systems. Stillbirth rates and their associating factors vary by socio-economic and geographical settings. Published data on stillbirths and their associating factors in the Volta Region of Ghana are limited. This limits understanding of local factors that must be considered in designing appropriate interventions to mitigate the occurrence of stillbirths. This study determined the incidence of stillbirths and associated factors among deliveries at Ho Teaching Hospital (HTH) and contributes to understanding the consistent high stillbirths in the country and potentially in other low-resourced settings in sub-Saharan Africa.

METHOD: This was a prospective cohort study involving pregnant women admitted for delivery at HTH between October 2019 and March 2020. Data on socio-demographic characteristics such as age and employment, obstetric factors including gestational age at delivery and delivery outcomes like birthweight were collected using a pretested structured questionnaire. The primary outcome was the incidence of stillbirths at the facility. Summary statistics were reported as frequencies, percentages and means. Logistic regression methods were used to assess for association between stillbirths and independent variables including age and birthweight. Odds ratios were reported with 95% confidence intervals and associations with p-values < 0.05 were considered statistically significant.

RESULTS: A total of 687 women and their 702 newborns contributed data for analysis. The mean age (SD) was 29.3 (6.3) years and close to two-thirds had had at least one delivery previously. Overall stillbirth incidence was 31.3 per 1000 births. Of the 22 stillbirths, 17 were antepartum. Pre-eclampsia was the most common hypertensive disorder of pregnancy observed (49.3%, 33/67). Among others, less than 3 antenatal visits and low birthweight increased the odds of stillbirths in the bivariate analysis. In the final multivariate model, pregnancy and delivery at 28-34 weeks gestation [AOR 9.37(95% CI 1.18-74.53); p = 0.034] and induction of labour [AOR 11.06 (95% CI 3.10-39.42); p < 0.001] remained significantly associated with stillbirths.

CONCLUSION: Stillbirth incidence was 31.3 per 1000 births with more than half being antepartum stillbirths. Pregnancy/delivery at 28-34 weeks’ gestation increased the odds of a stillbirth. Improving the quality of antenatal services, ensuring adherence to evidence-based protocols, accurate and prompt diagnosis and timely interventions of medical conditions in pregnancy particularly at 28-34 weeks’ gestation could reduce incidence of stillbirths.

PMID:38128029 | DOI:10.1371/journal.pone.0296076

PLoS One. 2023 Dec 21;18(12):e0295857. doi: 10.1371/journal.pone.0295857. eCollection 2023.

ABSTRACT

BACKGROUND: Although statins are often discontinued when myalgia arises, a causal relationship may not always exist. How well-tolerated statins are when rechallenge is blinded and controlled is unclear.

METHODS AND FINDINGS: We performed a systematic review and meta-analysis (PROSPERO CRD42023437648) to evaluate the success of statin rechallenge versus matched placebo in those who were previously statin intolerant. Our primary outcome was intolerance; our secondary outcome was the myalgia or global symptom score. Medline, Embase, CINAHL Plus, Scopus, and CENTRAL were searched from inception to May 1, 2023. Eligible trials were randomized controlled trials with parallel or crossover designs examining statin rechallenge in statin-intolerant adults. Two independent reviewers selected studies, extracted data, and assessed risk of bias (Cochrane Collaboration’s risk-of-bias tool 1). Relative risk (RR) and mean difference (MD) were estimated using fixed effect Mantel-Haenszel statistics. Of 1,941 studies screened, 8 met our inclusion criteria (8 to 491 participants from Asia, Europe, North America, and Oceana). Compared to placebo, intolerance was more common in statin users [325/906 (36%) vs 233/911 (26%), RR 1.40, 95% CI, 1.23 to 1.60, I2 = 0%, 7 trials, number needed to harm 10] and there was no statistically significant difference in myalgia or global symptom score on a 100-point scale [MD 1.08, 95% CI, -1.51 to 3.67, I2 = 0%, 5 trials]. Limitations include only 1 trial asking participants about intolerable symptoms (vs inferring intolerance from discontinuation or trial withdrawal); the small number of trials; the possibility of attrition bias; and the potential for carryover effects in crossover/n-of-1 trial designs.

CONCLUSIONS: Of those previously intolerant of statins who were rechallenged with a statin and compared to placebo recipients, medication intolerance was more common amongst statin recipients. However, there was no significant difference in mean myalgia or global symptom score between statin and placebo, and only one-third of those previously believed to be statin intolerant were unable to tolerate a statin on blinded rechallenge; one-quarter were intolerant of placebo.

PMID:38128013 | DOI:10.1371/journal.pone.0295857

PLoS One. 2023 Dec 21;18(12):e0296020. doi: 10.1371/journal.pone.0296020. eCollection 2023.

ABSTRACT

Randomized clinical trials (RCTs) are designed for measuring the effectiveness of the treatments and testing a hypothesis regarding the relative effect between two or more treatments. Trial designers are often interested in maximizing power when the total sample size is fixed or minimizing the required total sample size to reach a pre-specified power. One approach to maximizing power proposed by previous researchers is to leverage prior evidence using meta-analysis (NMA) to inform the sample size determination of a new trial. For example, researchers may be interested in designing a two-arm trial comparing treatments A and B which are already in the existing trial network but do not have any direct comparison. The researchers’ intention is to incorporate the result into an existing network for meta-analysis. Here we develop formulas to address these options and use simulations to validate our formula and evaluate the performance of different analysis methods in terms of power. We also implement our proposed method into the R package OssaNMA and publish an R Shiny app for the convenience of the application. The goal of the package is to enable researchers to readily adopt the proposed approach which can improve the power of an RCT and is therefore resource-saving. In the R Shiny app, We also provide the option to include the cost of each treatment which would enable researchers to compare the total treatment cost associated with each design and analysis approach. Further, we explore the effect of allocation to treatment group on study power when the a priori plan is to incorporate the new trial result into an existing network for meta-analysis.

PMID:38128003 | DOI:10.1371/journal.pone.0296020

PLoS One. 2023 Dec 21;18(12):e0293497. doi: 10.1371/journal.pone.0293497. eCollection 2023.

ABSTRACT

BACKGROUND: To curb the growing impact of drug shortages, Health Canada developed the Tiered Notification and Communication Framework which assigns potential shortages a corresponding tiered status. Tier-3 is assigned to shortages with the greatest potential impact on the healthcare system. This study aims to describe drug purchasing trends in response to Tier-3 shortages using three case-examples.

METHODS: We conducted a time-series analysis of monthly purchasing data for three out of 17 Tier-3 drug shortages (hydralazine, sarilumab, and medroxyprogesterone acetate) with publicly available reports in July 2021 and available IQVIA MIDAS data from January 2016 to December 2021. We assessed percent changes in purchasing at 1-, 3-, and 6-months after the onset of each Tier-3 drug shortage and interventional ARIMA modelling was used to assess the statistical significance.

RESULTS: Medroxyprogesterone acetate experienced a significant shift (p = 0.0370) in purchasing following its shortage, and the 1-, 3-, and 6-month percent changes were +14.9%, +6.8% and -3.1%, respectively. Hydralazine and sarilumab did not show a significant shift. The 1-, 3-, and 6-month percent changes for hydralazine were +15.5%, +10.2%, and +9.6% respectively and +25.2%, +45.1% and +39.2 for sarilumab.

CONCLUSIONS: These results indicate that drugs assigned a Tier-3 status may not show declines in purchasing in the months following status assignment, which may be due to policy responses following the assignment. However, more insight is needed into the mechanisms through which these policy measures impact shortages and whether they are functioning as intended.

PMID:38127996 | DOI:10.1371/journal.pone.0293497

JNCI Cancer Spectr. 2023 Dec 21:pkad106. doi: 10.1093/jncics/pkad106. Online ahead of print.

ABSTRACT

BACKGROUND: Many women diagnosed with cancer as adolescents and young adults (AYAs, ages 15-39 years) want biological children after cancer but lack information on the potential impact of their cancer history on future reproductive outcomes. We investigated the risk of adverse birth outcomes among AYA cancer survivors.

METHODS: We identified insured women diagnosed with AYA breast cancer, thyroid cancer, gynecologic cancers, lymphoma, or melanoma from 2003 to 2016 in the state of North Carolina or the Kaiser Permanente healthcare systems in Northern and Southern California. Post-diagnosis births to cancer survivors were each matched with up to 5 births to women without cancer. Risk ratios for preterm birth (<37 completed weeks,) very preterm birth (<34 completed weeks), low birth weight (<2,500 g), and small for gestational age (SGA, < 10th percentile of weight for gestational age) were estimated using modified Poisson regression.

RESULTS: Analyses included 1,648 births to 1,268 AYA cancer survivors and 7,879 births to 6,066 women without cancer. Overall, risk of preterm birth, very preterm birth, low birth weight, and SGA did not significantly differ between births to women with and without cancer. However, births to women with gynecologic cancers had a significantly increased risk of low birth weight (RR = 1.82; 95% CI: 1.03-3.21) and suggested increased risk of preterm birth (RR = 1.59; 95% CI: 0.99-2.54). Chemotherapy exposure was not associated with increased risk of adverse birth outcomes.

CONCLUSIONS: Women with gynecologic cancers, but not other cancers, had an increased risk of adverse birth outcomes compared to women without cancer.

PMID:38127994 | DOI:10.1093/jncics/pkad106