Tag: statistics

Trials. 2022 Sep 14;23(1):774. doi: 10.1186/s13063-022-06518-z.

ABSTRACT

BACKGROUND: COVID-19 pneumonia is associated with the development of acute respiratory distress syndrome (ARDS) displaying some typical histological features. These include diffuse alveolar damage with extensive pulmonary coagulation activation. This results in fibrin deposition in the microvasculature, leading to the formation of hyaline membranes in the air sacs. Well-conducted clinical trials have found that nebulised heparin limits pulmonary fibrin deposition, attenuates progression of ARDS, hastens recovery and is safe in non-COVID ARDS. Unfractionated heparin also inactivates the SARS-CoV-2 virus and prevents entry into mammalian cells. Nebulisation of heparin may therefore limit fibrin-mediated lung injury and inhibit pulmonary infection by SARS-CoV-2. Based on these findings, we designed the CHARTER-Ireland Study, a phase 1b/2a randomised controlled study of nebulised heparin in patients requiring advanced respiratory support for COVID-19 pneumonia.

METHODS: This is a multi-centre, phase 1b/IIa, randomised, parallel-group, open-label study. The study will randomise 40 SARs-CoV-2-positive patients receiving advanced respiratory support in a critical care area. Randomisation will be via 1:1 allocation to usual care plus nebulised unfractionated heparin 6 hourly to day 10 while receiving advanced respiratory support or usual care only. The study aims to evaluate whether unfractionated heparin will decrease the procoagulant response associated with ARDS up to day 10. The study will also assess safety and tolerability of nebulised heparin as defined by number of severe adverse events; oxygen index and respiratory oxygenation index of intubated and unintubated, respectively; ventilatory ratio; and plasma concentration of interleukin (IL)-1β, IL6, IL-8, IL-10 and soluble tumour necrosis factor receptor 1, C-reactive protein, procalcitonin, ferritin, fibrinogen and lactate dehydrogenase as well as the ratios of IL-1β/IL-10 and IL-6/IL-10. These parameters will be assessed on days 1, 3, 5 and 10; time to separation from advanced respiratory support, time to discharge from the intensive care unit and number tracheostomised to day 28; and survival to days 28 and 60 and to hospital discharge, censored at day 60. Some clinical outcome data from our study will be included in the international meta-trials, CHARTER and INHALE-HEP.

DISCUSSION: This trial aims to provide evidence of potential therapeutic benefit while establishing safety of nebulised heparin in the management of ARDS associated with SARs-CoV-2 infection.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04511923 . Registered on 13 August 2020. Protocol version 8, 22/12/2021 Protocol identifier: NUIG-2020-003 EudraCT registration number: 2020-003349-12 9 October 2020.

PMID:36104785 | DOI:10.1186/s13063-022-06518-z

BMC Neurol. 2022 Sep 14;22(1):346. doi: 10.1186/s12883-022-02857-1.

ABSTRACT

BACKGROUND: Chronic subdural haematoma (CSDH) is a common neurological condition affecting the elderly with decreased quality of life. Recurrence leads to increase in number of hospital admissions and surgical interventions. Several factors contribute to recurrence of chronic subdural haematoma, and determination of these factors will help institute measures to reduce recurrence of CSDH, cost of care and improved quality of life. The aim of this study was to determine the predictors of recurrence of chronic subdural haematoma in a cohort of patients presenting in a Sub-Saharan African Teaching Hospital.

METHODS: A prospective hospital-based cohort study of 62 participants who presented with CSDH and underwent burr-hole and drainage at the Neuroscience unit of the Korle-bu Teaching Hospital. The primary outcome of this study was the recurrence of CSDH within 3 months after the surgery. Data was entered into Microsoft Excel 2016 and exported to International Business Machine (IBM) Statistical Package for the Social Sciences (SPSS) version 21.0 for analysis. Predictors of recurrence of CSDH were determined using logistic regression with odds ratio calculated at the 95% confidence level and a p-value less than 0.05 accepted as statistically significant.

RESULTS: There was a male preponderance of 45 (72.6%), over females of 17 (27.4%). The mean age was 63.1 ± 13.6 years. The recurrence rate of CSDH was 21.0% whilst the mortality rate was 4.8%. Facial palsy and dysphasia were associated with the recurrence of CSDH (p = 0.045, 0.029). Hypertension and bilaterality were associated with recurrence of CSDH from a univariate analysis (p = 0.039, OR = 4.865, CI = 0.975-24.285; p = 0.005, OR = 5.979, CI = 1.585-22.557). In a multivariate logistic regression analysis, bilaterality was the only independent predictor of recurrence of CSDH (p = 0.030, AOR = 5.47, CI = 1.18-25.34).

CONCLUSIONS: Both hypertension and bilaterality showed statistically significant association with recurrence of CSDH. However, only bilaterality proved to be an independent predictor of recurrence of CSDH in patient who underwent burr-hole and drainage.

PMID:36104782 | DOI:10.1186/s12883-022-02857-1

BMC Geriatr. 2022 Sep 15;22(1):751. doi: 10.1186/s12877-022-03428-2.

ABSTRACT

BACKGROUND: Voice assistants enable older adults to communicate regarding their health as well as facilitate ageing in place. This study investigated the effects of communication style, anthropomorphic setting, and individual differences on the trust, acceptance, and mental workload of older adults using a voice assistant when communicating health issues.

METHODS: This is a mixed-methods study utilising both quantitative and qualitative methods. One hundred and six older adults (M = 71.8 years, SD = 4.6 years) participated in a 2 (communication style: social- vs. task-oriented; between-subject)[Formula: see text] 2 (anthropomorphic setting: ordinary profession vs. medical background; within-subject) mixed design experiment. The study used multivariate analysis of variance (MANOVA) to examine the effects of communication style, anthropomorphic setting of the voice assistant, and participants’ use frequency of digital devices on the trust, technology acceptance, and mental workload of older adults using a voice assistant in a health context. End-of-study interviews regarding voice assistant use were conducted with participants. Qualitative content analyses were used to assess the interview findings about the communication content, the more trustworthy anthropomorphic setting, and suggestions for the voice assistant.

RESULTS: Communication style, anthropomorphic setting, and individual differences all had statistically significant effects on older adults’ evaluations of the voice assistant. Compared with a task-oriented voice assistant, older adults preferred a social-oriented voice assistant in terms of trust in ability, integrity, and technology acceptance. Older adults also had better evaluations for a voice assistant with a medical background in terms of trust in ability, integrity, technology acceptance, and mental workload. In addition, older adults with more experience using digital products provided more positive evaluations in terms of trust in ability, integrity, and technology acceptance.

CONCLUSIONS: This study suggests that when designing a voice assistant for older adults in the health context, using a social-oriented communication style and providing an anthropomorphic setting in which the voice assistant has a medical background are effective ways to improve the trust and acceptance of older adults of voice assistants in an internet-of-things environment.

PMID:36104775 | DOI:10.1186/s12877-022-03428-2

BMC Musculoskelet Disord. 2022 Sep 15;23(1):862. doi: 10.1186/s12891-022-05813-9.

ABSTRACT

BACKGROUND: Children with cerebral palsy (CP) form a heterogeneous group and may have risk or protective factors for fractures compared with typically developing children. The fracture sites may also differ from those of children who do not have CP. We analyzed the fracture epidemiology in a total population of children with CP.

METHODS: This was a retrospective registry study based on data from the Swedish Cerebral Palsy Follow-Up Program (CPUP) and the Swedish National Patient Register. All children in the CPUP born in 2000-2015 were included. The Gross Motor Function Classification System (GMFCS) level, reported fractures, fracture site, and epilepsy diagnosis were recorded up to 2018. Hazards and hazard ratios were calculated for first-time fractures.

RESULTS: Of the 3,902 participants, 368 (9.4%) had at least one reported fracture. The cumulative risk of sustaining a fracture before age 16 years was 38.3% (95% confidence interval 33.9-42.4). The hazard for fracture was 7 times higher in children with epilepsy. The overall fracture incidence was not statistically significantly related to sex or GMFCS level. Fractures in the upper extremities were most prevalent in children with a lower GMFCS level, and femoral fractures were most prevalent in children at GMFCS level V. Most fractures occurred in early childhood and after 8 years of age.

CONCLUSIONS: Children with CP were at similar risk of sustaining fractures as typically developing children, but the risk was higher in children with comorbid epilepsy. Fractures occurred in children at GMFCS levels I-III at sites similar to those for typically developing children; fractures in the upper extremities were the most frequent. Children at GMFCS levels IV or V and those with epilepsy were more likely to have a fracture in the lower extremities, and the femur was the most frequent site.

PMID:36104768 | DOI:10.1186/s12891-022-05813-9

Eur J Med Res. 2022 Sep 14;27(1):178. doi: 10.1186/s40001-022-00802-z.

ABSTRACT

BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is a severe idiopathic disorder of bile metabolism; however, the etiology and pathogenesis of ICP remain unclear.

AIMS: This study comprehensively reviewed metabolomics studies related to ICP, to help in identifying the pathophysiological changes of ICP and evaluating the potential application of metabolomics in its diagnosis.

METHODS: Relevant articles were searched through 2 online databases (PubMed and Web of Science) from January 2000 to March 2022. The metabolites involved were systematically examined and compared. Pathway analysis was conducted through the online software MetaboAnalyst 5.0.

RESULTS: A total of 14 papers reporting 212 metabolites were included in this study. There were several highly reported metabolites: bile acids, such as glycocholic acid, taurochenodeoxycholic acid, taurocholic acid, tauroursodeoxycholic acid, and glycochenodeoxycholic acid. Dysregulation of metabolic pathways involved bile acid metabolism and lipid metabolism. Metabolites related to lipid metabolism include phosphatidylcholine, phosphorylcholine, phosphatidylserine, sphingomyelin, and ceramide.

CONCLUSIONS: This study provides a systematic review of metabolomics of ICP and deepens our understanding of the etiology of ICP.

PMID:36104763 | DOI:10.1186/s40001-022-00802-z

J Eat Disord. 2022 Sep 14;10(1):141. doi: 10.1186/s40337-022-00662-2.

ABSTRACT

Despite intensified research efforts into the underlying (neuro-)biology of eating disorders (EDs), only few reliable biomarkers of diagnostic or prognostic value have been identified to date. One promising line of research has focused on the role of peripheral blood-based biomarkers as potential contributors to the complex pathophysiology of EDs. One such candidate marker is brain-derived neurotrophic factor (BDNF), a neurotrophin broadly implicated in neuronal plasticity and food-intake regulation. A growing number of studies have targeted BDNF in EDs; culminating in several recent well-powered and controlled case-control studies, comprehensive meta-analyses, and review articles. In the current correspondence, we aim to put the recent meta-analysis of Shobeiri et al. (J Eat Disord 10(1):105, 2022) into perspective and argue that the finding suggestive of lower BDNF concentrations across individuals with EDs in comparison to healthy controls needs to be interpreted with caution. While this finding is compatible with those from earlier meta-analyses, it may be biased due to several reasons; most notably by the applied study selection procedures, insufficient consideration of influential determinants of BDNF concentrations, and generalization of results across the ED spectrum without sufficient statistical power. Further controlled and comprehensive studies are necessary to establish BDNF as a clinically informative biomarker of EDs.

PMID:36104758 | DOI:10.1186/s40337-022-00662-2

BMC Pharmacol Toxicol. 2022 Sep 14;23(1):70. doi: 10.1186/s40360-022-00612-3.

ABSTRACT

BACKGROUND: Although various pharmacological and nonpharmacological treatments are available for the chronic low back pain (CLBP), there is no consensus on the best optimal treatment for this condition. This study aimed to investigate the efficacy of co-administration of pregabalin and agomelatine versus pregabalin with placebo to treat CLBP.

METHODS: Forty-six CLBP patients without the surgical indication referred to the outpatient orthopedic clinic of Rasoul-e-Akram Hospital, Tehran, Iran, were randomly divided into two study groups: Group A [pregabalin (75 mg twice per day) + placebo] and Group B [pregabalin (75 mg twice per day) + agomelatine (25 mg per night)]. Patients were evaluated at weeks 0, 4, and 8. Outcome measures were the Persian versions of the Brief Pain Inventory (BPI) interference scale, Roland-Morris Disability Questionnaire (RMDQ), The Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Survey (SF-36), and General Health Questionnaire-28 (GHQ-28) were used.

RESULTS: At weeks 4 and 8 after the intervention, all evaluated measures showed significant improvement in both study groups (P < 0.01). The mean improvement of GHQ-28 was 3.7 ± 1.22 in group A and 13.1 ± 4.71 in group B. This difference was statistically significant (P = 0.003). Other outcomes did not vary substantially between the two research groups. Agomelatine treatment was well tolerated, with no significant adverse effects seen in patients. Liver tests of all patients were routine during the study period. Major adverse effect was not seen in any patient. The prevalence of Minor side effects was not significantly different between two study groups.

CONCLUSION: Compared with the pregabalin and placebo, co-administration of pregabalin and agomelatine had no added effect on improving pain scores in CLBP patients. However, the patients’ general health was significantly improved after the combined administration of pregabalin and agomelatine.

TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials before starting the study (NO.IRCT20200620047852N1, Registration date: 23/06/2020).

PMID:36104745 | DOI:10.1186/s40360-022-00612-3

BMC Health Serv Res. 2022 Sep 14;22(1):1161. doi: 10.1186/s12913-022-08518-w.

ABSTRACT

BACKGROUND: Achieving equity in the distribution of health services is one major goal in the health system. This study aimed to determine equality in distributing health human resources (physicians) in the Qazvin University of Medical Sciences before and after the Health Transformation Plan (HTP) based on the Hirschman-Herfindahl index (HHI).

METHODS: In this descriptive-analytical study, the statistical population was general practitioners (GPs), specialists and subspecialists in the Qazvin University of Medical Sciences from 2011-to 2017. We extracted demographic statistics of the cities from the Statistical Center of Iran. Physicians’ statistics were obtained from the Curative Affairs Deputy at the Qazvin University of Medical Sciences. We assessed inequality using the HHI.

RESULTS: The highest number of GPs was in 2014, and specialists and subspecialists were in 2017. The lowest number of GPs, specialists, and subspecialists were in 2016, 2011 and 2015. The HHI for GPs in 2011-2017 was between 4300 and 5200. The lowest concentration for specialists before the HTP plan was the cardiologist with 3300, and after the HTP, the internal specialist with 3900. Also, the numerical value of this index for all subspecialty physicians after the HTP was 10,000, the highest level of concentration.

CONCLUSION: The values obtained from the HHI index indicate the high concentration and disproportionate and inequitable distribution of human resources in the health sector in this province. The number of specialists in some cities is still much less than acceptable, and some cities even have shortcomings in the critical specialists.

PMID:36104727 | DOI:10.1186/s12913-022-08518-w

BMC Endocr Disord. 2022 Sep 14;22(1):229. doi: 10.1186/s12902-022-01139-8.

ABSTRACT

BACKGROUND: IDegLira is a fixed-ratio combination of insulin degludec and liraglutide with proven efficacy against simpler regimens and non-inferiority against basal-bolus insulin therapy. However, the evaluation of its real-world effectiveness is hindered by technical issues and requires further exploration. Thus we aimed to compare effectiveness of insulin degludec/liraglutide (IDegLira) versus intensified conventional insulin therapy (ICT) for type 2 diabetes in a real-world setting.

METHODS: This retrospective cohort study from an outpatient clinic in Hungary included people who initiated IDegLira due to inadequate glycaemic control (HbA1c > 7.0% [53.0 mmol/mol]) with oral and/or injectable antidiabetic drugs. Data were compared with a historical cohort who initiated ICT. Outcomes included HbA1c, body weight, and hypoglycaemia differences over 18 months of follow-up.

RESULTS: Data were included from 227 and 72 people who initiated IDegLira and ICT, respectively. Estimated mean difference (MD) in HbA1c at 18 months favoured IDegLira versus ICT (MD 0.60, 95% CI 0.88-0.32 [MD 6.6 mmol/mol, 95% CI 9.6-3.5]). More people reached target HbA1c ≤7.0% (53.0 mmol/mol) with IDegLira than ICT (odds ratio 3.36, 95% CI 1.52-7.42). IDegLira treatment was associated with weight loss compared with gain for ICT (MD 6.7 kg, 95% CI 5.0-8.5). The hazard ratio for hypoglycaemia comparing IDegLira with ICT was 0.18 (95% CI 0.08-0.49).

CONCLUSIONS: Treatment with IDegLira over 18 months resulted in greater HbA1c reductions, weight loss versus gain, and a lower rate of hypoglycaemia versus ICT in people with type 2 diabetes.

PMID:36104712 | DOI:10.1186/s12902-022-01139-8

BMC Med. 2022 Sep 15;20(1):307. doi: 10.1186/s12916-022-02499-7.

ABSTRACT

BACKGROUND: Gestational diabetes (GDM) is prevalent and benefits from timely and effective treatment, given the short window to impact glycemic control. Clinicians face major barriers to choosing effectively among treatment modalities [medical nutrition therapy (MNT) with or without pharmacologic treatment (antidiabetic oral agents and/or insulin)]. We investigated whether clinical data at varied stages of pregnancy can predict GDM treatment modality.

METHODS: Among a population-based cohort of 30,474 pregnancies with GDM delivered at Kaiser Permanente Northern California in 2007-2017, we selected those in 2007-2016 as the discovery set and 2017 as the temporal/future validation set. Potential predictors were extracted from electronic health records at different timepoints (levels 1-4): (1) 1-year preconception to the last menstrual period, (2) the last menstrual period to GDM diagnosis, (3) at GDM diagnosis, and (4) 1 week after GDM diagnosis. We compared transparent and ensemble machine learning prediction methods, including least absolute shrinkage and selection operator (LASSO) regression and super learner, containing classification and regression tree, LASSO regression, random forest, and extreme gradient boosting algorithms, to predict risks for pharmacologic treatment beyond MNT.

RESULTS: The super learner using levels 1-4 predictors had higher predictability [tenfold cross-validated C-statistic in discovery/validation set: 0.934 (95% CI: 0.931-0.936)/0.815 (0.800-0.829)], compared to levels 1, 1-2, and 1-3 (discovery/validation set C-statistic: 0.683-0.869/0.634-0.754). A simpler, more interpretable model, including timing of GDM diagnosis, diagnostic fasting glucose value, and the status and frequency of glycemic control at fasting during one-week post diagnosis, was developed using tenfold cross-validated logistic regression based on super learner-selected predictors. This model compared to the super learner had only a modest reduction in predictability [discovery/validation set C-statistic: 0.825 (0.820-0.830)/0.798 (95% CI: 0.783-0.813)].

CONCLUSIONS: Clinical data demonstrated reasonably high predictability for GDM treatment modality at the time of GDM diagnosis and high predictability at 1-week post GDM diagnosis. These population-based, clinically oriented models may support algorithm-based risk-stratification for treatment modality, inform timely treatment, and catalyze more effective management of GDM.

PMID:36104698 | DOI:10.1186/s12916-022-02499-7