Nevin Manimala

Trials. 2022 Sep 6;23(1):755. doi: 10.1186/s13063-022-06667-1.

ABSTRACT

BACKGROUND: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.

METHODS: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.

DISCUSSION: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.

ETHICS AND DISSEMINATION: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.

TRIAL REGISTRATION: EudraCT 2016-001,350-18 . Registered on 14 April 2016.

CLINICALTRIALS: gov NCT02949739 . Registered on 31 October 2016.

PMID:36068618 | DOI:10.1186/s13063-022-06667-1

J Neuroinflammation. 2022 Sep 6;19(1):218. doi: 10.1186/s12974-022-02582-z.

ABSTRACT

BACKGROUND: Triggering receptor expressed on myeloid cell 1 (Trem1) is an important regulator of cellular inflammatory responses. Neuroinflammation is a common thread across various neurological diseases. Soluble Trem1 (sTrem1) in plasma is associated with the development of central nervous system disorders. However, the extent of any causative effects of plasma sTrem1 on the risk of these disorders is still unclear.

METHOD: Genetic variants for plasma sTrem1 levels were selected as instrumental variables. Summary-level statistics of neurological disorders, including Alzheimer’s disease (AD), Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), epilepsy, cerebrovascular diseases, and migraine were collected from genome-wide association studies (GWASs). Whether plasma sTrem1 was causally associated with neurological disorders was assessed using a two-sample Mendelian randomization (MR) analysis, with false discovery rate (FDR)-adjusted methods applied.

RESULTS: We inferred suggestive association of higher plasma sTrem1 with the risk of AD (odds ratio [OR] per one standard deviation [SD] increase = 1.064, 95% CI 1.012-1.119, P = 0.014, P_FDR = 0.056). Moreover, there was significant association between plasma sTrem1 level and the risk of epilepsy (OR per one SD increase = 1.044, 95% CI 1.016-1.072, P = 0.002, P_FDR = 0.032), with a modest statistical power of 41%. Null associations were found for plasma sTrem1 with other neurological diseases and their subtypes.

CONCLUSIONS: Taken together, this study indicates suggestive association between plasma sTrem1 and AD. Moreover, higher plasma sTrem1 was associated with the increased risk of epilepsy. The findings support the hypothesis that sTrem1 may be a vital element on the causal pathway to AD and epilepsy.

PMID:36068612 | DOI:10.1186/s12974-022-02582-z

BMC Public Health. 2022 Sep 6;22(1):1688. doi: 10.1186/s12889-022-14095-8.

ABSTRACT

BACKGROUND: The World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. There is no recent data on the health status of only asylum seekers who have recently arrived in their Western host country. The purpose of this study was to determine the health status of asylum seekers and search for explanatory factors for this health status.

METHODS: This cross-sectional observational study screened the mental and somatic health of adult asylum seekers who had arrived in France within the past 21 days and went to the Marseille single center between March 1 and August 31, 2021. In order to study the explanatory factors of the asylum seekers’ health status, a multivariate analysis was performed using a logistic regression model to predict the health status. Factors taken into account were those significantly associated with outcome (level < 0.05) in univariate analysis.

RESULTS: In total, 419 asylum seekers were included and 96% CI95%[93;97.3] had at least one health disorder. Concerning mental health, 89% CI95% [85.1;91.4] had a mental disorder and in terms of somatic health exclusively, 66% CI95% [61.4;70.6] had at least one somatic disorder. Women were more likely to have a somatic disease OR = 1.80 [1.07; 3.05]. We found a statistically significant association between the presence of at least one disorder and sleeping in a public space OR = 3.4 [1.02;11.28] p = 0.046. This association is also found for mental disorders OR = 2.36 [1.16;4.84], p = 0.018.

CONCLUSIONS: Due to the high prevalence of health disorders our study found, asylum seekers are a population with many care needs when they arrive in their host country. The main factors linked to a poor health status seem to be related to a person’s sex, geographical origin and sleeping in a public space.

PMID:36068557 | DOI:10.1186/s12889-022-14095-8

Trials. 2022 Sep 6;23(1):754. doi: 10.1186/s13063-022-06664-4.

ABSTRACT

BACKGROUND: Platform trials are well-known for their ability to investigate multiple arms on heterogeneous patient populations and their flexibility to add/drop treatment arms due to efficacy/lack of efficacy. Because of their complexity, it is important to develop highly optimized, transparent, and rigorous designs that are cost-efficient, offer high statistical power, maximize patient benefit, and are robust to changes over time.

METHODS: To address these needs, we present a Bayesian platform trial design based on a beta-binomial model for binary outcomes that uses three key strategies: (1) hierarchical modeling of subgroups within treatment arms that allows for borrowing of information across subgroups, (2) utilization of response-adaptive randomization (RAR) schemes that seek a tradeoff between statistical power and patient benefit, and (3) adjustment for potential drift over time. Motivated by a proposed clinical trial that aims to find the appropriate treatment for different subgroup populations of ischemic stroke patients, extensive simulation studies were performed to validate the approach, compare different allocation rules, and study the model operating characteristics.

RESULTS AND CONCLUSIONS: Our proposed approach achieved high statistical power and good patient benefit and was also robust against population drift over time. Our design provided a good balance between the strengths of both the traditional RAR scheme and fixed 1:1 allocation and may be a promising choice for dichotomous outcomes trials investigating multiple subgroups.

PMID:36068547 | DOI:10.1186/s13063-022-06664-4

BMC Neurol. 2022 Sep 6;22(1):335. doi: 10.1186/s12883-022-02853-5.

ABSTRACT

BACKGROUND: Stroke is the second leading cause of death above the age of 60 years, and the fifth leading cause in people aged 15 to 59 years old as reported by the World Health Organization global burden of diseases. Stroke in the young is particularly tragic because of the potential to create long-term disability, burden on the victims, their families, and the community at large. Despite this, there is limited data on stroke in young adults, and its risk factors in Uganda. Therefore, we determined the frequency and risk factors for stroke among young adults at Mulago hospital.

METHODS: A case control study was conducted among patients presenting consecutively to the general medical wards with stroke during the study period September 2015 to March 2016. A brain Computerized Tomography scan was performed to confirm stroke and classify the stroke subtype. Controls were patients that presented to the surgical outpatient clinic with minor surgical conditions, matched for age and sex. Social demographic, clinical and laboratory characteristics were assessed for both cases and controls. Descriptive statistics including frequencies, percentages, means, and standard deviation were used to describe the social demographics of case and controls as well as the stroke types for cases. To determine risk factors for stroke, a conditional logistic regression, which accounts for matching (e.g., age and sex), was applied. Odds ratio (with 95% confidence interval) was used as a measure for associations.

RESULTS: Among 51 patients with stroke, 39(76.5%) had ischemic stroke and 12(23.5%) had hemorrhagic stroke. The mean age was 36.8 years (SD 7.4) for stroke patients (cases) and 36.8 years (SD 6.9) for controls. Female patients predominated in both groups 56.9% in cases and 52.9% in controls. Risk factors noted were HIV infection, OR 3.57 (95% CI 1.16-10.96), elevated waist to hip ratio, OR 11.59(95% CI 1.98-68.24) and sickle cell disease, OR 4.68 (95% CI 1.11-19.70). This study found a protective effect of oral contraceptive use for stroke OR 0.27 95% CI 0.08-0.87. There was no association between stroke and hypertension, diabetes, and hyperlipidemia.

CONCLUSION: Among young adults with stroke, ischemic stroke predominated over hemorrhagic stroke. Risk factors for stroke were HIV infection, elevated waist to hip ratio and sickle cell disease.

PMID:36068544 | DOI:10.1186/s12883-022-02853-5

Orphanet J Rare Dis. 2022 Sep 6;17(1):347. doi: 10.1186/s13023-022-02505-4.

ABSTRACT

OBJECTIVES: Behçet’s disease is a rare, chronic, incurable, multisystemic disease. It causes significant morbidity, with patients experiencing symptoms including mucous membrane ulcers, and joint pain and swelling. It is an important cause of avoidable blindness due to ocular involvement. The aetiology is unknown. The aims were to identify population prevalence of Behçet’s disease in Wales in comparison to other endemic and non-endemic regions, and provide an epidemiological profile of a case series of adult patients. This is the first analysis of data from the Adult Rare Diseases Surveillance Registry for Wales, established in 2020 as part of the COVID-19 pandemic response.

RESULTS: Between 1995 and 2020, 347 adults and 5 children were recorded in Wales with a diagnosis of Behçet’s disease. Population prevalence was calculated as 11.1 per 100,000 population. Of the adult cases, 76.9% were female, and 6.6% died before the end of the study period. When comparing genders, there were no statistically significant differences in age at diagnosis, mortality or socioeconomic status. There was no evidence that the age at which cases were diagnosed had changed over time. Survival analyses showed no significant differences in durations of survival between genders or individuals residing in different WIMD 2019 quintiles. Age at diagnosis was the only factor significantly and independently associated with poorer durations of survival (p < 0.001).

PMID:36068543 | DOI:10.1186/s13023-022-02505-4

BMC Med Inform Decis Mak. 2022 Sep 6;22(1):236. doi: 10.1186/s12911-022-01980-w.

ABSTRACT

INTRODUCTION: Chronic myeloid leukemia (CML) is a myeloproliferative disorder resulting from the translocation of chromosomes 19 and 22. CML includes 15-20% of all cases of leukemia. Although bone marrow transplant and, more recently, tyrosine kinase inhibitors (TKIs) as a first-line treatment have significantly prolonged survival in CML patients, accurate prediction using available patient-level factors can be challenging. We intended to predict 5-year survival among CML patients via eight machine learning (ML) algorithms and compare their performance.

METHODS: The data of 837 CML patients were retrospectively extracted and randomly split into training and test segments (70:30 ratio). The outcome variable was 5-year survival with potential values of alive or deceased. The dataset for the full features and important features selected by minimal redundancy maximal relevance (mRMR) feature selection were fed into eight ML techniques, including eXtreme gradient boosting (XGBoost), multilayer perceptron (MLP), pattern recognition network, k-nearest neighborhood (KNN), probabilistic neural network, support vector machine (SVM) (kernel = linear), SVM (kernel = RBF), and J-48. The scikit-learn library in Python was used to implement the models. Finally, the performance of the developed models was measured using some evaluation criteria with 95% confidence intervals (CI).

RESULTS: Spleen palpable, age, and unexplained hemorrhage were identified as the top three effective features affecting CML 5-year survival. The performance of ML models using the selected-features was superior to that of the full-features dataset. Among the eight ML algorithms, SVM (kernel = RBF) had the best performance in tenfold cross-validation with an accuracy of 85.7%, specificity of 85%, sensitivity of 86%, F-measure of 87%, kappa statistic of 86.1%, and area under the curve (AUC) of 85% for the selected-features. Using the full-features dataset yielded an accuracy of 69.7%, specificity of 69.1%, sensitivity of 71.3%, F-measure of 72%, kappa statistic of 75.2%, and AUC of 70.1%.

CONCLUSIONS: Accurate prediction of the survival likelihood of CML patients can inform caregivers to promote patient prognostication and choose the best possible treatment path. While external validation is required, our developed models will offer customized treatment and may guide the prescription of personalized medicine for CML patients.

PMID:36068539 | DOI:10.1186/s12911-022-01980-w

BMC Nurs. 2022 Sep 6;21(1):249. doi: 10.1186/s12912-022-01022-w.

ABSTRACT

BACKGROUND: In an acute hospital setting, diabetes can require intensive management with medication modification, monitoring and education. Yet little is known about the experiences and perspectives of nursing/midwifery staff and patients. The aim of this study was to investigate diabetes management and care for patients with diabetes in an acute care setting from the perspectives of nursing/midwifery staff and patients.

METHODS: A convergent mixed-methods study design. Patients with diabetes (Type 1, Type 2 or gestational diabetes) recruited from a public health service in Melbourne, Australia completed a survey and nurses and midwives employed at the health service participated in focus groups. Descriptive statistics were used to summarise the survey data. Thematic analysis was used for the free-text survey comments and focus group data.

RESULTS: Surveys were completed by 151 patients. Although more than half of the patients were satisfied with the diabetes care they had received (n = 96, 67.6%), about a third felt the hospital nursing/midwifery staff had ignored their own knowledge of their diabetes care and management (n = 43, 30.8%). Few reported having discussed their diabetes management with the nursing/midwifery staff whilst in hospital (n = 47, 32.6%) or thought the nurses and midwives had a good understanding of different types of insulin (n = 43, 30.1%) and their administration (n = 47, 33.3%). Patients also reported food related barriers to their diabetes management including difficulties accessing appropriate snacks and drinks (n = 46, 30.5%), restricted food choices and timing of meals (n = 41, 27.2%). Fourteen nurses and midwives participated in two focus groups. Two main themes were identified across both groups: 1. challenges caring for patients with diabetes; and 2. lack of confidence and knowledge about diabetes management.

CONCLUSIONS: Patients and nursing/midwifery staff reported challenges managing patients’ diabetes in the hospital setting, ensuring patients’ optimal self-management, and provision of suitable food and timing of meals. It is essential to involve patients in their diabetes care and provide regular and up-to-date training and resources for nursing/midwifery staff to ensure safe and high-quality inpatient diabetes care and improve patient and staff satisfaction.

PMID:36068537 | DOI:10.1186/s12912-022-01022-w

BMC Pregnancy Childbirth. 2022 Sep 6;22(1):686. doi: 10.1186/s12884-022-05019-w.

ABSTRACT

BACKGROUND: Globally, nearly 295,000 women die every year during and following pregnancy and childbirth. Emergency obstetric and newborn care (EmONC) can avert 75% of maternal mortality if all mothers get quality healthcare. Improving maternal health needs identification and addressing of barriers that limit access to quality maternal health services. Hence, this study aimed to assess the quality of EmONC service and its predictors in Wolaita Zone, southern Ethiopia.

METHODOLOGY: A facility-based cross-sectional study was conducted in 14 health facilities. A facility audit was conducted on 14 health facilities, and 423 women were randomly selected to participate in observation of care and exit interview. The Open Data Kit (ODK) platform and Stata version 17 were used for data entry and analysis, respectively. Frequencies and summary statistics were used to describe the study population. Simple and multiple linear regressions were done to identify candidate and predictor variables of service quality. Coefficients with 95% confidence intervals were used to declare the significance and strength of association. Input, process, and output quality indices were created by calculating the means of standard items available or actions performed by each category and were used to describe the quality of EmONC.

RESULT: The mean input, process, and output EmONC services qualities were 74.2, 69.4, and 79.6%, respectively. Of the study participants, 59.2% received below 75% of the standard clinical actions (observed quality) of EmONC services. Women’s educational status (B = 5.35, 95% C.I: 0.56, 10.14), and (B = 8.38, 95% C.I: 2.92, 13.85), age (B = 3.86, 95% C.I: 0.39, 7.33), duration of stay at the facility (B = 3.58, 95% C.I: 2.66, 4.9), number of patients in the delivery room (B = – 4.14, 95% C.I: – 6.14, – 2.13), and care provider’s experience (B = 1.26, 95% C.I: 0.83, 1.69) were independent predictors of observed service quality.

CONCLUSION: The EmONC services quality was suboptimal in Wolaita Zone. Every three-in-five women received less than three-fourths of the standard clinical actions. The health system, care providers, and other stakeholders should emphasize improving the quality of care by availing medical infrastructure, adhering to standard procedures, enhancing human resources for health, and providing standard care regardless of women’s characteristics.

PMID:36068531 | DOI:10.1186/s12884-022-05019-w

Cardiovasc Diabetol. 2022 Sep 6;21(1):178. doi: 10.1186/s12933-022-01612-7.

ABSTRACT

BACKGROUND: Offspring of mothers with type 1 diabetes have an increased risk for acquiring early onset cardiovascular disease (CVD). Arterial stiffness, measured as pulse wave velocity (PWV), is a non-invasive biomarker for CVD risk assessment. Our aim is to determine whether PWV is increased in young adult offspring of mothers with type 1 diabetes.

METHODS: This is a case-control study carried out in the hospital district of Helsinki and Uusimaa, Finland. 75 offspring of mothers with type 1 diabetes (cases) and 84 offspring of mothers without diabetes (controls), aged 18-23 years, were enrolled in this study. All participants attended clinical assessments, including questionnaires and laboratory tests. Carotid-femoral PWV (cfPWV), carotid-radial PWV (crPWV), and PWV ratio were measured from each participant using the Complior Analyse mechanotransducer (Alam Medical, France). Student’s t-test and chi-squared test were used to assess differences between the groups. Stata 17.0, StataCorp LP (College Station, TX, USA) statistical package was used for the analysis.

RESULTS: We did not observe any differences in conventional CVD risk factors: systolic blood pressure, LDL, Hb_A1c, and smoking between cases and controls. We detected higher cfPWV in cases 6.5 (SD ± 1.2) m/s than in controls 6.2 (SD ± 0.7) m/s, p = 0.049, after adjustments for BMI, smoking, mean arterial pressure, height, and pulse rate was made. We did not observe any difference between cases and controls regarding crPWV or PWV ratio. Additionally, we detected no sex differences.

CONCLUSIONS: We report a novel finding of signs of increased arterial stiffness already in young adult offspring of mothers with type 1 diabetes compared to matched offspring of mothers without diabetes. Our finding suggests that exposure to an adverse intrauterine environment of type 1 diabetes mothers may affect the vascular health of offspring already in young adulthood. Additional research within this topic is warranted.

PMID:36068528 | DOI:10.1186/s12933-022-01612-7