ResearchPad - diabetes-and-endocrinology https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Androgens In Men Study (AIMS): protocol for meta-analyses of individual participant data investigating associations of androgens with health outcomes in men]]> https://www.researchpad.co/article/elastic_article_12552 This study aims to clarify the role(s) of endogenous sex hormones to influence health outcomes in men, specifically to define the associations of plasma testosterone with incidence of cardiovascular events, cancer, dementia and mortality risk, and to identify factors predicting testosterone concentrations. Data will be accrued from at least three Australian, two European and four North American population-based cohorts involving approximately 20 000 men.Methods and analysisEligible studies include prospective cohort studies with baseline testosterone concentrations measured using mass spectrometry and 5 years of follow-up data on incident cardiovascular events, mortality, cancer diagnoses or deaths, new-onset dementia or decline in cognitive function recorded. Data for men, who were not taking androgens or drugs suppressing testosterone production, metabolism or action; and had no prior orchidectomy, are eligible. Systematic literature searches were conducted from 14 June 2019 to 31 December 2019, with no date range set for searches. Aggregate level data will be sought where individual participant data (IPD) are not available. One-stage IPD random-effects meta-analyses will be performed, using linear mixed models, generalised linear mixed models and either stratified or frailty-augmented Cox regression models. Heterogeneity in estimates from different studies will be quantified and bias investigated using funnel plots. Effect size estimates will be presented in forest plots and non-negligible heterogeneity and bias investigated using subgroup or meta-regression analyses.Ethics and disseminationEthics approvals obtained for each of the participating cohorts state that participants have consented to have their data collected and used for research purposes. The Androgens In Men Study has been assessed as exempt from ethics review by the Human Ethics office at the University of Western Australia (file reference number RA/4/20/5014). Each of the component studies had obtained ethics approvals; please refer to respective component studies for details. Research findings will be disseminated to the scientific and broader community via the publication of four research articles, with each involving a separate set of IPD meta-analyses (articles will investigate different, distinct outcomes), at scientific conferences and meetings of relevant professional societies. Collaborating cohort studies will disseminate findings to study participants and local communities.PROSPERO registration numberCRD42019139668. ]]> <![CDATA[How self-stigma affects patient activation in persons with type 2 diabetes: a cross-sectional study]]> https://www.researchpad.co/article/elastic_article_12539 Self-stigma is associated with lower patient activation levels for self-care in persons with type 2 diabetes mellitus (T2DM). However, the causal pathway linking self-stigma with patient activation for self-care has not been shown. In order to determine how self-stigma affects patient activation for self-care, we tested a two-path hypothetical model both directly and as mediated by self-esteem and self-efficacy.DesignA cross-sectional study.SettingTwo university hospitals, one general hospital and one clinic in Japan.ParticipantsT2DM outpatients receiving treatment (n=209) completed a self-administered questionnaire comprising the Self-Stigma Scale, Patient Activation Measure, Rosenberg Self-Esteem Scale, General Self-Efficacy Scale, Patient Health Questionnaire, haemoglobin A1c test, age, sex and body mass index.Primary and secondary outcome measuresSelf-stigma levels were measured by using the Self-Stigma Scale. Patient activation levels were measured by the Patient Activation Measure.ResultsPath analysis showed a strong relationship between self-stigma and patient activation (χ2=27.55, p=0.120; goodness-of-fit index=0.97; adjusted goodness-of-fit index=0.94; comparative fit index=0.98; root mean square error of approximation=0.04). Self-stigma had a direct effect on patient activation (β=−0.20; p=0.002). Indirectly, self-stigma affected patient activation along two paths (β=0.31; p<0.001) by reducing self-esteem (β=−0.22; p<0.001) and self-efficacy (β=−0.36; p<0.001).ConclusionsDue to the cross-sectional design of the study, longitudinal changes between all the variables cannot be established. However, the findings indicate that self-stigma affected patient activation for self-care, both directly and as mediated by self-esteem and self-efficacy. Interventions that increase self-esteem and self-efficacy may decrease self-stigma in patients with T2DM, thus increasing patient activation for self-care. ]]> <![CDATA[Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT]]> https://www.researchpad.co/article/elastic_article_9086 The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.DesignIn this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.SettingThis German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.Participants368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.InterventionsNPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.Primary and secondary outcome measuresPrimary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.ResultsIn the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI−4.7% – 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.ConclusionsNPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.Trial registration numbers NCT01480362 and DRKS00003347. ]]> <![CDATA[Metabolomics window into the role of acute kidney injury after coronary artery bypass grafting in diabetic nephropathy progression]]> https://www.researchpad.co/article/elastic_article_8326 Metabolomics has emerged as a valuable tool to discover novel biomarkers and study the pathophysiology of diabetic nephropathy (DN). However, the effect of postoperative acute kidney injury (AKI) on diabetes mellitus (DM) to chronic DN progression has not been evaluated from the perspective of metabolomics.MethodsA group of type 2 diabetes mellitus (T2DM) inpatients, who underwent off-pump coronary artery bypass grafting (CABG), were enrolled in our study. According to whether postoperative AKI occurred, patients were grouped in either the AKI group (AKI, n = 44) or the non-AKI group (NAKI, n = 44). Urine samples were collected from these patients before and 24 h after operation. Six patients from the AKI group and six patients from the NAKI group were chosen as the pilot cohort for untargeted metabolomics analysis, with the goal of identifying postoperative AKI-related metabolites. To understand the possible role of these metabolites in the chronic development of renal injury among T2DM patients, trans-4-hydroxy-L-proline and azelaic acid were quantified by targeted metabolomics analysis among 38 NAKI patients, 38 AKI patients, 46 early DN patients (DN-micro group), and 34 overt DN patients (DN-macro group).ResultsUntargeted metabolomics screened 61 statistically distinguishable metabolites in postoperative urine samples, compared with preoperative urine samples. Via Venn diagram analysis, nine of 61 were postoperative AKI-related metabolites, including trans-4-hydroxy-L-proline, uridine triphosphate, p-aminobenzoate, caffeic acid, adrenochrome, δ-valerolactam, L-norleucine, 5′-deoxy-5′-(methylthio) adenosine, and azelaic acid. By targeted metabolomics analysis, the level of trans-4-hydroxy-L-proline increased gradually from the NAKI group to the AKI, DN-micro, and DN-macro groups. For azelaic acid, the highest level was found in the NAKI and DN-micro groups, followed by the DN-macro group. The AKI group exhibited the lowest level of azelaic acid.ConclusionsThe detection of urinary trans-4-hydroxy-L-proline after AKI could be treated as an early warning of chronic DN progression and might be linked to renal fibrosis. Urinary azelaic acid can be used to monitor renal function noninvasively in DM and DN patients. Our results identified markers of AKI on DM and the chronic progression of DN. In addition, the progression of DN was associated with AKI-like episodes occurring in DM. ]]> <![CDATA[Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol]]> https://www.researchpad.co/article/Nfdb56cc8-1c6a-428b-b4f8-219f4f863e15 Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysisIn this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and disseminationThe study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration numberNCT03994536 ]]> <![CDATA[Predictive value of CONUT score combined with serum CA199 levels in postoperative survival of patients with pancreatic ductal adenocarcinoma: a retrospective study]]> https://www.researchpad.co/article/N2eefad10-a581-44e6-b789-8bd63f0bd645

Background

The preoperative controlling nutritional status (CONUT) score and serum carbohydrate antigen 199 (CA199) levels are individually correlated with the prognosis of pancreatic ductal adenocarcinoma (PDAC). The objective of this study aimed to investigate the efficacy of CONUT score and CA199 (CONUT-CA199) combination in predicting the prognosis of PDAC patients undergoing radical surgery.

Methods

We retrospectively analyzed the preoperative CONUT scores and serum CA199 levels of 294 patients with PDAC who underwent radical resection at the Affiliated Hospital of Southwest Medical University between March 2012 and July 2019. Patients were divided into four groups on the basis of their preoperative CONUT scores and serum CA199 levels: CONUTlow/CA199low (1), CONUTlow/CA199high (2), CONUThigh/CA199low (3) and CONUThigh/CA199high (4). The prognostic effects were compared among the groups.

Results

CONUThigh was more frequent in patients with positive peripancreatic infiltration and Clavien–Dindo classification of ≥IIIa (P < 0.001). Kaplan–Meier analysis revealed obvious difference in overall survival (OS) and recurrence-free survival (RFS) among patients with PDAC having CONUT-CA199 scores of 1, 2, 3 and 4 (P < 0.001). Peripancreatic infiltration, lymph node metastasis, pTNM stage, CONUT score, serum CA199 levels and CONUT-CA199 classification were found to be the independent prognostic factors for OS and RFS in multivariate analyses. In time-dependent receiver operating characteristic (ROC) analyses, the area of the CONUT-CA199 score under the ROC curve (AUC) was higher than that of the preoperative CONUT score or serum CA199 levels for the prediction of OS and RFS.

Conclusion

CONUT-CA199 classification may be more effective in predicting the postoperative prognosis of PDAC patients.

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<![CDATA[Nomograms for predicting overall survival and cancer-specific survival in young patients with pancreatic cancer in the US based on the SEER database]]> https://www.researchpad.co/article/Nc163a081-e30a-4539-9d1d-f30b97862201

Background

The incidence of young patients with pancreatic cancer (PC) is on the rise, and there is a lack of models that could effectively predict their prognosis. The purpose of this study was to construct nomograms for predicting the overall survival (OS) and cancer-specific survival (CSS) of young patients with PC.

Methods

PC patients younger than 50 years old from 2004 to 2015 in the Surveillance, Epidemiology, and End Results (SEER) database were selected and randomly divided into training set and validation set. Univariable and forward stepwise multivariable Cox analysis was used to determine the independent factors affecting OS. The Fine and Gray competing risk regression model was used to determine the independent factors affecting CSS. We used significant variables in the training set to construct nomograms predicting prognosis. The discrimination and calibration power of models were evaluated by concordance index (C-index), calibration curve and 10-flod cross-validation.

Results

A total of 4,146 patients were selected. Multivariable Cox analysis showed that gender, race, grade, pathological types, AJCC stage and surgery were independent factors affecting OS. The C-index of the nomogram predicting OS in training and validation was 0.733 (average = 0.731, 95% CI [0.724–0.738]) and 0.742 (95% CI [0.725–0.759]), respectively. Competing risk analysis showed that primary site, pathological types, AJCC stage and surgery were independent factors affecting CSS. The C-index of the nomogram predicting CSS in training and validation set was 0.792 (average = 0.765, 95% CI [0.742–0.788]) and 0.776 (95% CI [0.773–0.779]), respectively. C-index based on nomogram was better in training and validation set than that based on AJCC stage. Calibration curves showed that these nomograms could accurately predict the 1-, 3- and 5-year OS and CSS both in training set and validation set.

Conclusions

The nomograms could effectively predict OS and CSS in young patients with PC, which help clinicians more accurately and quantitatively judge the prognosis of individual patients.

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<![CDATA[Assessment of Thyroid Function in Patients With Alkaptonuria]]> https://www.researchpad.co/article/N7e83e389-a67e-41e3-8247-0989d700fadb

Key Points

Question

Is alkaptonuria associated with thyroid dysfunction?

Findings

In this cohort study, 125 adults with alkaptonuria followed up for a median of 93 months were found to have a 16.0% prevalence of primary hypothyroidism. This prevalence was significantly higher than the 3.7% prevalence in the general population.

Meaning

Results of this study suggest that screening for hypothyroidism should be considered in patients with alkaptonuria.

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<![CDATA[How valid are projections of the future prevalence of diabetes? Rapid reviews of prevalence-based and Markov chain models and comparisons of different models’ projections for England]]> https://www.researchpad.co/article/N3c5001fd-ac2e-453b-b667-d439412942d7

Objectives

To examine validity of prevalence-based models giving projections of prevalence of diabetes in adults, in England and the UK, and of Markov chain models giving estimates of economic impacts of interventions to prevent type 2 diabetes (T2D).

Methods

Rapid reviews of both types of models. Estimation of the future prevalence of T2D in England by Markov chain models; and from the trend in the prevalence of diabetes, as reported in the Quality and Outcomes Framework (QOF), estimated by ordinary least squares regression analysis.

Setting

Adult population in England and UK.

Main outcome measure

Prevalence of T2D in England and UK in 2025.

Results

The prevalence-based models reviewed use sample estimates of past prevalence rates by age and sex and projected population changes. Three most recent models, including that of Public Health England (PHE), neither take account of increases in obesity, nor report Confidence Intervals (CIs). The Markov chain models reviewed use transition probabilities between states of risk and death, estimated from various sources. None of their accounts give the full matrix of transition probabilities, and only a minority report tests of validation. Their primary focus is on estimating the ratio of costs to benefits of preventive interventions in those with hyperglycaemia, only one reported estimates of those developing T2D in the absence of a preventive intervention in the general population.

Projections of the prevalence of T2D in England in 2025 were (in millions) by PHE, 3.95; from the QOF trend, 4.91 and by two Markov chain models, based on our review, 5.64 and 9.07.

Conclusions

To inform national policies on preventing T2D, governments need validated models, designed to use available data, which estimate the scale of incidence of T2D and survival in the general population, with and without preventive interventions.

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<![CDATA[Assessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol]]> https://www.researchpad.co/article/N6f96291c-be38-4591-ba01-833e74f1020a

Introduction

Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy.

Methods and analysis

The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10–16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9–10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost–utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D.

Ethics and dissemination

Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations.

Trial registration number

NCT02871089; Pre-results.

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<![CDATA[Cultural adaptation of a patient decision-aid for insulin therapy]]> https://www.researchpad.co/article/N6b816d89-134d-432b-a145-cbc04614b9bc

Introduction

Patient decision-aids (PDAs) support patients in selecting evidence-based treatment options. PDA is useful only if the user understands the content to make personalised decisions. Cultural adaptation is a process of adjusting health messages so that the information is accurate, relevant and understandable to users from a different population. A PDA has been developed to assist Malaysian patients with secondary drug failure to initiate insulin therapy to control their type 2 diabetes mellitus (T2DM). Likewise, patients with T2DM in neighbouring Singapore face similar barriers in commencing insulin treatment, which a PDA may facilitate decision-making in selecting personalised therapy.

Objective

The study aimed to explore the views and perceptions of Singaporean primary care providers on the Malaysia PDA to initiate insulin therapy and described the cultural adaptation process used in the design and development of a new PDA, which would be trialled in a Singapore primary healthcare institution.

Method

Qualitative research method was deployed to conduct one-to-one in-depth interviews of the healthcare providers at the trial site (SingHealth Polyclinics—SHP), including six primary care physicians and four nurses to gather their views and feedbacks on the Malaysian PDA. The interviews were transcribed, audited and analysed (standard content analysis) to identify themes relating to the content, layout, concerns of the original PDA and suggestions to the design of the new SHP PDA.

Results

Cultural adaptation of the new PDA includes change to the overall design, graphics (including pictograms), presentation styles, additional contextualised content (personalisation, subheadings, cost and treatment option), modified phrasing of the subtitles and concerns (choice of words) relevant to the new users.

Conclusion

A PDA on insulin therapy underwent cultural adaptation before its implementation in another population in a neighbouring country. Its relevance and effectiveness will be evaluated in future research.

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<![CDATA[Direct non-medical and indirect costs of diabetes and its associated complications in Vietnam: an estimation using national health insurance claims from a cross-sectional survey]]> https://www.researchpad.co/article/N038b7232-b3b5-43cb-b2fd-ee2a22082258

Objective

The prevalence of diabetes in Vietnam has increased from 2.5% in 2007 to 5.5% in 2017, but the burden of direct non-medical and indirect costs is unknown. The objective of this study was to estimate the direct non-medical costs and indirect costs due to type 2 diabetes mellitus (T2DM) and its associated complications among Vietnam Health Insurance System (VHIS) enrollees in Vietnam.

Design

The first phase was a cross-sectional survey of patients with T2DM. In the second phase, data from the previous phase were used to predict direct non-medical costs and presenteeism costs of VHIS enrollees diagnosed with T2DM based on demographic and clinical characteristics in 2017. The human-capital approach was used for the calculation of indirect costs.

Setting and participants

This study recruited 315 patients from a national hospital, a provincial hospital and a district hospital aged 18 or above, diagnosed with T2DM, enrolled in VHIS, and having at least one visit to hospitals between 1 June and 30 July 2018. The VHIS dataset contained 1,395,204 patients with T2DM.

Outcome measures

The direct non-medical costs and presenteeism were collected from the survey. Absenteeism costs were estimated from the VHIS database. Costs of premature mortality were calculated based on the estimates from secondary sources.

Results

The total direct non-medical and indirect costs were US$239 million in 2017. Direct non-medical costs were US$78 million, whereas indirect costs were US$161 million. Costs of absenteeism, presenteeism and premature mortality corresponded to 17%, 73% and 10% of the indirect costs. Patients incurred annual mean direct non-medical costs of US$56. Annual mean absenteeism and presenteeism costs for patients in working age were US$61 and US$267, respectively.

Conclusions

The impact of T2DM on direct non-medical and indirect costs on diabetes is substantial. Direct non-medical and absenteeism costs were higher in patients with complications.

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<![CDATA[Experiences of pregnant women with gestational diabetes mellitus: a systematic review of qualitative evidence protocol]]> https://www.researchpad.co/article/N501fa442-e65e-4cbd-b1a3-71db3d26a521

Introduction

The incidence of gestational diabetes mellitus (GDM) is increasing and an issue of global concern. GDM can cause severe adverse effects for pregnant women and their fetuses. This systematic review is proposed to explore women’s experiences during the pregnancy with GDM. This review will provide insights into the physical, psychological and social adaptation experiences of women with GDM that can help to identify challenges of glycaemic control and provide targeted care and interventions to improve maternal and child health.

Methods and analysis

The databases we will search include English databases (ie, PubMed, CINAHL, Embase, the Cochrane Library, Web of Science, Joanna Briggs Institute (JBI) Database of Systematic Reviews, PsycINFO, OpenGrey and Deep Blue) and Chinese databases (ie, China Biology Medicine disc, China National Knowledge Infrastructure, and VIP Database for Chinese Technical Periodicals). Published qualitative evidence of life changes or experiences of the women with GDM will be searched. There will be no limits on publication year. Two reviewers will independently use the JBI Critical Appraisal Checklist for Qualitative Research for methodological validity prior to inclusion in this review. Any disagreements regarding article evaluation will be resolved through discussion or with a third reviewer. Data will be extracted using the standardised data extraction tool from JBI System for the Unified Management, Assessment and Review of Information. Synthesis will include in-depth reading of the original text and the discovery of the results, and then summarising similar categories for more advanced synthesised findings. The final synthesised findings will be graded according to the ConQual approach for establishing confidence.

Ethics and dissemination

This study does not require ethical approval as primary data will not be collected. Results of this systematic review will be submitted to peer-reviewed international journals for publication and be presented in relevant international conferences.

PROSPERO registration number

CRD42019132065.

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<![CDATA[Type 1 diabetes mellitus and educational attainment in childhood: a systematic review]]> https://www.researchpad.co/article/N7fb528d8-ad9d-4219-8cab-d9fb984319dd

Objectives

The primary objective of this systematic review was to evaluate available literature on whether type 1 diabetes mellitus (T1DM) has an impact on educational attainment in individuals undertaking high stakes standardised testing at the end of compulsory schooling.

Design

A systematic review was undertaken comparing educational attainment for individuals with and without T1DM who have undertaken high stakes testing at the end of compulsory schooling.

Data sources

A comprehensive search of MEDLINE, MEDLINE (epub ahead of print, in-process and other non-indexed citations), EMBASE, Web of Science, British Education Index, Education Resources Information Center and Cumulative Index to Nursing and Allied Health Literature was undertaken on 15 January 2018 and updated on 17 January 2019.

Eligibility criteria

Included studies fulfilled the following criteria: observational study or randomised controlled trial; included individuals who have undertaken high stakes testing at the end of compulsory schooling; compared the grades obtained by individuals with T1DM with a representative population control.

Data extraction and synthesis

Two reviewers performed study selection and data extraction independently. Quality and risk of bias in the observational studies included were assessed using the Newcastle-Ottawa Scale. A detailed narrative synthesis of the included studies was completed.

Results

3103 articles were identified from the database search, with two Swedish cohort studies (using the same linked administrative data) meeting final inclusion criteria. A small but statistically significant difference was reported in mean final grades, with children with T1DM found to have lower mean grades than their non-diabetic counterparts (adjusted mean difference 0.07–0.08).

Conclusions

More contemporary research is required to evaluate the impact of T1DM in childhood on educational attainment in individuals undertaking high stakes standardised testing at the end of compulsory schooling, taking into consideration the substantial advances in management of T1DM in the last decade.

PROSPERO registration number

CRD42017084078.

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<![CDATA[Impact of examined lymph node count on long-term survival of T1-2N0M0 double primary NSCLC patients after surgery: a SEER study]]> https://www.researchpad.co/article/N270bfab1-03be-4183-bc65-e32a9174aca4

Purpose

The relationship between examined lymph nodes (ELN) and survival has been confirmed in several single early-stage malignancies. We studied the association between the ELN count and the long-term survival of T1-2N0M0 double primary non-small cell lung cancer (DP-NSCLC) patients after surgery, based on the Surveillance, Epidemiology and End Results (SEER) database.

Methods

A total of 948 patients were identified and their independent prognostic factors were analyzed. These factors included the ELN count, which related to overall survival (OS) and the cancer-specific survival (CSS) of synchronous (n = 426) and metachronous (n = 522) T1-2N0M0 DP-NSCLC patients after surgery.

Results

X-tile analysis indicated that the cutoff value for the sum of ELNs was 22 for both OS and CSS in the synchronous DP-NSCLC group. Patients with a sum of ELNs >22 were statistically more likely to survive than those with ≤22 ELNs. X-tile analysis revealed that the ELN count of the second lesion was related to both OS and CSS in the metachronous DP-NSCLC group. The optimal cutoff value was nine. These results were confirmed using univariate and multivariate Cox regression analyses.

Conclusion

Our findings indicate that ELN count was highly correlated with the long-term survival of T1-2N0M0 double primary NSCLC patients after surgery.

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<![CDATA[lncRNA–mRNA competing endogenous RNA network in IR-hepG2 cells ameliorated by APBBR decreasing ROS levels: a systematic analysis]]> https://www.researchpad.co/article/Nd84c0e1b-c3f9-498a-93e1-ad661bfe9fd5

Background

Radix Astragali (Astragalus membranaceus var. mongholicus (Bunge)) and Coptis chinensis (Coptis chinensis var. angustiloba) are two commonly prescribed traditional Chinese herbs for diabetes. Astragalus Polysaccharide (AP) and Berberine (BBR) are active ingredients of these two herbs respectively and they are scientifically proved to have immunomodulatory and anti-inflammatory effects. They are also known for their antidiabetic potential by ameliorating insulin resistance (IR). AP and BBR have shown different advantages in treating diabetes according to previous reports. However, very few studies focus on the combined activities of the two potential antidiabetic ingredients. In this study, we discovered that reactive oxygen species (ROS) accumulated in IR-hepG2 cells and APBBR can decrease ROS level in model group significantly. We conjectured that APBBR can ameliorate IR in hepG2 cells by decreasing ROS level. In order to verify this hypothesis, we obtained phenotype and transcriptome information of IR-HepG2 cells and explore the underlying mechanism of the combination of AP and BBR(APBBR) activity on the relationship between ROS change in IR at whole-transcriptome level, so as to shed new light to efficacy and application of APBBR in treating diabetes.

Methods

The IR cell model was established with high-level insulin intervention. Glucose content, HepG2 cell viability as well as ROS level was detected to study the effect of IR-hepG2 cell phenotype. Unbiased genome-wide RNA sequencing was used to investigate alterations in experimental groups. Then, GO and KEGG functional enrichment was performed to explore the function and pathway of target genes. Venn analysis found out the differentially expressed lncRNAs that had close relationship with IR and ROS. Finally, we screened out candidate lncRNAs and these target genes to construct interaction network of differentiated lncRNA–miRNA–mRNA by according to the principle of competitive endogenous RNA (ceRNA).

Results

The biochemical experiments showed that APBBR administration could improve the proliferation activity of IR-HepG2 cells and decrease ROS level in model cells. The GO and KEGG functional enrichment analyses demonstrated several mRNAs remarkably enriched in biological processes and signaling pathways related to ROS production and IR progression. Interaction network suggest that APBBR ameliorates IR in HepG2 cells by regulating the expression of multiple genes and activating relevant signaling pathway to decrease ROS level. Thus, we demonstrated that APBBR ameliorated IR in hepG2 cells via the ROS-dependent pathway.

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<![CDATA[Prevalence of and related risk factors in oral mucosa diseases among residents in the Baoshan District of Shanghai, China]]> https://www.researchpad.co/article/Nec8566ef-bea1-4fab-8a7d-74e91e330ea0

Background

Oral mucosal diseases (OMDs) encompass a variety of different types of diseases. Our aim was to evaluate the prevalence and related risk factors of OMDs among residents in the Baoshan District of Shanghai, China, and provide a scientific basis for prevention and control strategies.

Methods

A sample of 653 residents aged 17 to 92 years from the Baoshan community was investigated in 2014. Each resident was surveyed by questionnaire to evaluate their oral mucosa and oral mucosa examinations were conducted. We followed up with 607 residents in 2018. All data were statistically analyzed using the SPSS 25.0 software package (Chicago, IL, USA) at the general population, gender and age levels. A X2 test was used to compare rates of risk factors and logistic regression analysis was used to detect the correlation between disease and risk factors.

Results

The prevalence rate of OMDs was found to be 9.19%–9.56% (2014–2018). The most common OMDs were atrophic glossitis (1.84%), recurrent aphthous ulcer (RAU, 1.68%), burning mouth syndrome (BMS, 1.38%), oral lichen planus (OLP, 1.23%) and traumatic ulcers (1.23%). The prevalence of RAU and BMS in different age groups was significantly different. Tobacco and alcohol use and psychological factors in the OMDs group were higher than the no-OMDs group. Systemic diseases including diabetes mellitus (DM) was significantly relevant to OLP.

Conclusion

Age, tobacco and alcohol use, and psychological factor correlated strongly with the occurrence and development of OMDs, and they should be the focus of primary prevention. General epidemiological studies suggested that OLP was closely related to DM.

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<![CDATA[Moderation effects of food intake on the relationship between urinary microbiota and urinary interleukin-8 in female type 2 diabetic patients]]> https://www.researchpad.co/article/Ne4765de9-81ac-4eca-9ceb-240d484e750d

Background

Our previous study demonstrated that the composition of the urinary microbiota in female patients with type 2 diabetes mellitus (T2DM) was correlated with the concentration of urinary interleukin (IL)-8. As the composition of urine is mainly determined by diet, diet might mediate the correlation.

Methods

Seventy female T2DM patients and 70 healthy controls (HCs) were recruited. Midstream urine was used for the urine specimens. Urinary IL-8 was determined by enzyme-linked immunosorbent assay. A Chinese Food Frequency Questionnaire was used to collect food intake data. The independent variables in the hierarchical regression analysis were the relative abundances of the bacterial genera and species that were significantly different between the T2DM and HCs and between the T2DM patients with and without detectable urinary IL-8, and the bacterial genera associated with IL-8 concentration in the multiple regression model reported in our previous research. IL-8 concentration was the dependent variable, and nutrient intakes were moderator variables.

Results

Fiber and vitamin B3 and E intake exerted enhancing effects, and water intake exerted a buffering effect, on the positive relationship between the relative abundance of Ruminococcus and IL-8 concentration (p < 0.05). Cholesterol and magnesium intake exerted enhancing effects on the positive relationship between the relative abundance of Comamonas and IL-8 concentration (p < 0.05).

Conclusion

Modulating T2DM patients’ dietary patterns may prevent bladder inflammation.

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<![CDATA[Within-person coupling of estradiol, testosterone, and cortisol in women athletes]]> https://www.researchpad.co/article/N23c181c2-bfbe-43ce-8f6c-7e968ca85f5a

Purpose

In variety of settings cortisol and testosterone are positively “coupled.” That is, within-person fluctuations of cortisol and testosterone levels occur in parallel—increases and decreases in one hormone are associated with corresponding increases and decreases in the other. The present report explored hormone coupling in women athletes in two studies selected because they included measurements of salivary levels of cortisol, testosterone, and estradiol—a hormone that has been only infrequently studied in the context of competitive athletics.

Methods

Consenting members of Emory University’s varsity volleyball and soccer teams gave saliva samples on multiple occasions in the run-up to and over the course of two different intercollegiate contests.

Results

Volleyball and soccer players showed remarkably similar hormone-specific patterns of increase in relationship to the different stages of competition—before warm-up, after warm-up, and after competition. For both the volleyball and soccer team, Hierarchical Linear Model (HLM) analyses showed estradiol as being significantly coupled with testosterone which was also coupled with cortisol.

Conclusions

This is, apparently, the first report of significant within-person coupling between estradiol and testosterone in the context of competitive athletic stress. These two hormones may be coupled in a wide variety of circumstances not limited to ones involving sport competition, and results reported here should encourage exploration of the extent to which coordinated fluctuations in estradiol, testosterone, and cortisol levels are present in other, more neutral settings and the ways in which the coordination of these fluctuating hormone levels may benefit human performance.

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<![CDATA[Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial]]> https://www.researchpad.co/article/Nd3968ee2-b4d6-4555-9992-b3a132eac97a

Introduction

Current intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.

Methods and analysis

A cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients’ blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.

Ethics and dissemination

Ethical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.

Trial registration number

NCT04023734.

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