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Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial

Por: Gregory · J. W. · Townson · J. · Channon · S. · Cohen · D. · Longo · M. · Davies · J. · Harman · N. · Hood · K. · Pickles · T. · Playle · R. · Randell · T. · Robling · M. · Touray · M. · Trevelyan · N. · Warner · J. · Lowes · L.
Objective

To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.

Design

A multicentre randomised controlled trial (January 2008/October 2013).

Setting

Eight paediatric diabetes centres in England, Wales and Northern Ireland.

Participants

203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers.

Intervention

Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care.

Main outcome measures

Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources.

Results

203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms.

Conclusions

There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes.

Trial registration number

ISRCTN78114042.

Structural brain changes in hyperthyroid Graves disease: protocol for an ongoing longitudinal, case-controlled study in Göteborg, Sweden--the CogThy project

Por: Holmberg · M. O. · Malmgren · H. · Berglund · P. · Bunketorp-Käll · L. · Heckemann · R. A. · Johansson · B. · Klasson · N. · Olsson · E. · Skau · S. · Nystrom Filipsson · H.
Introduction

Cognitive impairment and reduced well-being are common manifestations of Graves’ disease (GD). These symptoms are not only prevalent during the active phase of the disease but also often prevail for a long time after hyperthyroidism is considered cured. The pathogenic mechanisms involved in these brain-derived symptoms are currently unknown. The overall aim of the CogThy study is to identify the mechanism behind cognitive impairment to be able to recognise GD patients at risk.

Methods and analysis

The study is a longitudinal, single-centre, case-controlled study conducted in Göteborg, Sweden on premenopausal women with newly diagnosed GD. The subjects are examined: at referral, at inclusion and then every 3.25 months until 15 months. Examinations include: laboratory measurements; eye evaluation; neuropsychiatric and neuropsychological testing; structural MRI of the whole brain, orbits and medial temporal lobe structures; functional near-infrared spectroscopy of the cerebral prefrontal cortex and self-assessed quality of life questionnaires. The primary outcome measure is the change in medial temporal lobe structure volume. Secondary outcome measures include neuropsychological, neuropsychiatric, hormonal and autoantibody variables. The study opened for inclusion in September 2012 and close for inclusion in October 2019. It will provide novel information on the effect of GD on medial temporal lobe structures and cerebral cortex functionality as well as whether these changes are associated with cognitive and affective impairment, hormonal levels and/or autoantibody levels. It should lead to a broader understanding of the underlying pathogenesis and future treatment perspectives.

Ethics and dissemination

The study has been reviewed and approved by the Regional Ethical Review Board in Göteborg, Sweden. The results will be actively disseminated through peer-reviewed journals, national and international conference presentations and among patient organisations after an appropriate embargo time.

Trial registration number

44321 at the public project database for research and development in Västra Götaland County, Sweden (https://www.researchweb.org/is/vgr/project/44321).

Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet

Por: Jensen · S. B. K. · Lundgren · J. R. · Janus · C. · Juhl · C. R. · Olsen · L. M. · Rosenkilde · M. · Holst · J. J. · Stallknecht · B. M. · Madsbad · S. · Torekov · S. S.
Introduction

The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.

Methods and analysis

This is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.

Ethics and dissemination

The trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Trial registration number

2015-005585-32

Using telemedicine to support care for people with type 2 diabetes mellitus: a qualitative analysis of patients perspectives

Por: Lee · J. Y. · Chan · C. K. Y. · Chua · S. S. · Paraidathathu · T. · Lee · K. K.-C. · Tan · C. S. S. · Nasir · N. · Lee · S. W. H.
Objective

Telemedicine has been promoted as an economical and effective way to enhance patient care, but its acceptance among patients in low-income and middle-income countries is poorly understood. This study is aimed to explore the experiences and perspectives of people with type 2 diabetes mellitus that used telemedicine to manage their condition.

Design

In-depth and focus group interviews were conducted with participants who have engaged in telemedicine. Questions included were participants’ perception on the programme being used, satisfaction as well as engagement with the telemedicine programme. All interviews and focus groups were audio-recorded and transcribed verbatim. Data were analysed using a thematic approach.

Participants and setting

People with type 2 diabetes (n=48) who participated in a randomised controlled study which examined the use of telemedicine for diabetes management were recruited from 11 primary care clinics located within the Klang Valley.

Results

Twelve focus groups and two in-depth interviews were conducted. Four themes emerged from the analysis: (1) generational difference; (2) independence and convenience, (3) sharing of health data and privacy and (4) concerns and challenges. The main obstacles found in patients using the telemedicine systems were related to internet connectivity and difficulties experienced with system interface. Cost was also another significant concern raised by participants. Participants in this study were primarily positive about the benefits of telemedicine, including its ability to provide real-time data and disease monitoring and the reduction in clinic visits.

Conclusion

Despite the potential benefits of telemedicine in the long-term care of diabetes, there are several perceived barriers that may limit the effectiveness of this technology. As such, collaboration between educators, healthcare providers, telecommunication service providers and patients are required to stimulate the adoption and the use of telemedicine.

NCT0246680.

Association of liver enzymes levels with fasting plasma glucose levels in Southern China: a cross-sectional study

Por: Huang · L.-L. · Guo · D.-H. · Xu · H.-Y. · Tang · S.-T. · Wang · X. X. · Jin · Y.-P. · Wang · P.
Objective

According to several studies, liver enzymes levels are associated with fasting plasma glucose (FPG) levels. However, the association stratified by body mass index (BMI) remains to be elucidated, especially in Southern China. Therefore, the aim of this study was to investigate the correlation between liver enzymes levels and FPG levels stratified by BMI in Southern China.

Design

Cross-sectional study.

Participants and setting

3056 individuals participated in real-time interviews and blood tests in Southern China. Participants were divided into three groups (underweight, normal weight and overweight or obesity) based on BMI cut-offs.

Main outcome measured

Partial correlation analysis was performed to investigate the relationship between FPG levels and liver tests. Multivariate logistic regression analyses were applied to calculate the adjusted ORs for FPG levels based on liver enzymes levels.

Results

There was no association between liver enzymes and FPG either in the underweight group or in the normal weight group; however, a significant correlation was observed in the overweight or obesity group (alanine transaminase (ALT), p

Conclusions

The association of liver enzymes levels with FPG levels differed based on different BMI cut-offs. ALT levels were significantly positively associated with FPG levels in the overweight or obesity group, but not in the other two groups; AST levels were not associated with FPG levels in any group.

Ability of verbal autopsy data to detect deaths due to uncontrolled hyperglycaemia: testing existing methods and development and validation of a novel weighted score

Por: Blackstock · S. · Witham · M. D. · Wade · A. N. · Crampin · A. · Beran · D. · Ogle · G. D. · Davies · J. I.
Objectives

Verbal autopsy (VA) is a useful tool to ascertain cause of death where no other mechanisms exist. We aimed to assess the utility of VA data to ascertain deaths due to uncontrolled hyperglycaemia and to develop a weighted score (WS) to specifically identify cases. Cases were identified by a study or site physician with training in diabetes. These diagnoses were also compared with diagnoses produced by a standard computer algorithm (InterVA-4).

Setting

This study was done using VA data from the Health and Demographic Survey sites in Agincourt in rural South Africa. Validation of the WS was done using VA data from Karonga in Malawi.

Participants

All deaths from ages 1 to 49 years between 1992 and 2015 and between 2002 and 2016 from Agincourt and Karonga, respectively. There were 8699 relevant deaths in Agincourt and 1663 in Karonga.

Results

Of the Agincourt deaths, there were 77 study physician classified cases and 58 computer algorithm classified cases. Agreement between study physician classified cases and computer algorithm classified cases was poor (Cohen’s kappa 0.14). Our WS produced a receiver operator curve with area under the curve of 0.952 (95% CI 0.920 to 0.985). However, positive predictive value (PPV) was below 50% when the WS was applied to the development set and the score was dominated by the necessity for a premortem diagnosis of diabetes. Independent validation showed the WS performed reasonably against site physician classified cases with sensitivity of 86%, specificity of 99%, PPV of 60% and negative predictive value of 99%.

Conclusion

Our results suggest that widely used VA methodologies may be missing deaths due to uncontrolled hyperglycaemia. Our WS may offer improved ability to detect deaths due to uncontrolled hyperglycaemia in large populations studies where no other means exist.

Pay-for-performance programmes reduce stroke risks in patients with type 2 diabetes: a national cohort study

Por: Chou · C.-W. · Kung · P.-T. · Chou · W.-Y. · Tsai · W.-C.
Objectives

A pay-for-performance (P4P) programme is a management strategy that encourages healthcare providers to deliver high quality of care. In Taiwan, the P4P programme has been implemented for diabetes, and certified diabetes physicians voluntarily enrol patients with diabetes into the P4P programme. The objectives of this study were to compare the risk of stroke and its related factors in patients with type 2 diabetes who were enrolled in a P4P programme compared with those who were not.

Study design

This study is a natural experiment in Taiwan. A retrospective cohort investigation was conducted from 2002 to 2013, which included 459 726 patients with type 2 diabetes, who were grouped according to P4P enrolment status following a propensity score matching process.

Methods

We reviewed patients ≥45 years of age newly diagnosed with type 2 diabetes mellitus (DM) from the National Health Insurance Research Database in Taiwan. A Cox proportional hazards model was used to compare the relative risk of stroke between patients with type 2 DM enrolled in the P4P programme and those who were not enrolled.

Results

Compared with the patients not enrolled, there was a significantly lower stroke risk in P4P participants (HR=0.97, 95% CI 0.95 to 0.99). Although a significantly lower risk of haemorrhagic stroke was observed (HR=0.87, 95% CI 0.82 to 0.93) in P4P participants, no statistically significant difference for the risk of ischaemic stroke between P4P and non-P4P patients (HR=0.99, 95% CI 0.97 to 1.02) was found. Following stratification analysis, a significantly reduced stroke risk was observed in male patients with type 2 diabetes, but not in women.

Conclusions

Participants in Taiwan’s Diabetes P4P programme displayed a significantly reduced stroke risk, especially haemorrhagic stroke. We recommend the continual promotion of this programme to the general public and to physicians.

Anti-diabetic agents for prevention of type 2 diabetes mellitus in people with pre-diabetes: a systematic review and network meta-analysis protocol

Por: Wang · X. · Liu · J. · Huang · L. · Zeng · H. · He · G. · Chen · L. · Ma · R. · Fu · W. · Ning · B.
Introduction

Type 2 diabetes mellitus (T2DM) is a substantial health problem worldwide. Pre-diabetic state is associated with increased risk for the development of diabetes. There are various pharmacological therapies with glucose-lowering activity for diabetes prevention. Of those, most are being compared with placebo instead of active agents. The relative effects and safety of different glucose-lowering drugs still remain uncertain. To address this gap, we will conduct a systematic review and network meta-analysis (NMA) to evaluate comparative efficacy and safety of glucose-lowering agents for T2DM prevention in patients with pre-diabetes.

Methods and analysis

PubMed, the Cochrane library and Embase will be searched from inception to December 2019 for relevant randomised controlled trials (RCTs) that examined anti-diabetic drugs for diabetes prevention in patients with pre-diabetes. Two reviewers working independently will screen titles, abstracts and full papers. Data extraction will also be completed by two independent authors. The primary outcome will be the incidence of T2DM in patients with pre-diabetes at baseline. Secondary outcomes will include the achievement of normoglycaemia, all-cause mortality, cardiovascular mortality and hypoglycaemic event. Pairwise meta-analysis and NMA will be conducted for each outcome using a frequentist random-effects model. Additionally, subgroup analyses will also be performed. The comparison-adjusted funnel plot will be used to assess publication bias. The overall quality of evidence will be rated with the Grading of Recommendations Assessment, Development and Evaluation framework. Data analysis will be conducted using Stata V.14.0.

Ethics and dissemination

Ethics approval is not required. We plan to submit the results of this study to a peer-review journal.

PROSPERO registration number

CRD42019119157.

Feasibility of a 6-month pilot randomised controlled trial of resistance training on cognition and brain health in Canadian older adults at-risk for diabetes: study protocol

Por: Furlano · J. A. · Nagamatsu · L. S.
Introduction

Type 2 diabetes (T2D) is associated with cognitive deficits and increased risk of dementia, and thus individuals at high risk for T2D (ie, those who are overweight or prediabetic) are also at greater risk for cognitive decline. Aerobic exercise is known to preserve and improve cognitive function, but the effects of resistance training (RT) are much less known in older adults. Moreover, research on the effects of RT on cognition and brain health (structure and function) in older adults at-risk for diabetes is limited. To address this question, a 6-month RT intervention is needed. Importantly, before conducting a full-scale randomised controlled trial (RCT), we are conducting a feasibility pilot study to assess potential recruitment rates, adherence and retention in this specific population.

Methods and analysis

We are conducting a 6-month, thrice-weekly RT RCT. Participants (aged 60–80; sedentary; fasting plasma glucose of 6.1–7.0 mmol/L or body mass index ≥25) are randomised into one of two groups: (1) RT or (2) balance and tone (control). Based on other exercise trials using a similar population, we will consider our trial feasible if we have adherence and retention at 70%. Recruitment rate will be measured as time it takes to enrol 20 participants. To assess behavioural and MRI data, we will report descriptive statistics and estimation using a 95% CI.

Ethics and dissemination

Our study has received ethics approval from the Health Sciences Research Ethics Board at Western University. As this is a small pilot study, data will only be made available to other researchers on request. Results from this study will be disseminated via academic publication.

Trial registration number

NCT03254381

Risk models and scores for metabolic syndrome: systematic review protocol

Por: Ibrahim · M. S. · Pang · D. · Randhawa · G. · Pappas · Y.
Introduction

Metabolic syndrome ‘a clustering of risk factors which includes hypertension central obesity, impaired glucose metabolism with insulin resistance and dyslipidaemia’ affects approximately 20%–25% of the global adult population. Individuals with metabolic syndrome have two to threefold risk of developing cardiovascular disease and a fivefold risk of developing developing diabetes and death from all causes. Although there is rapid proliferation of risk scores for predicting the risk of developing metabolic syndrome later in life, yet, these are seldom used in the practice. Therefore, the purpose of this review is to determine the performance of risk models and scores for predicting the metabolic syndrome.

Methods and analysis

Articles will be sought for from electronic databases (MEDLINE, CINAHL, PubMed and Web of Science) as well as the Cochrane Library. Further manual search of reference lists and grey literatures will be conducted. The search will cover from the start of indexing to 3 October 2018. Identified studies will be included if they fulfil the study selection criteria. Quality of studies will be appraised using suitable criteria for the risk models. The risk scores in the final sample of the review will be ranked/prioritised based on previous quality criteria for prognostic risk models. Lastly, the impact of the models will be ascertained by tracking citations on Google Scholar.

Ethics and dissemination

This study does not require formal ethical approval as primary data will not be collected. The results will be disseminated through a peer-reviewed publication and relevant conference presentations.

PROSPERO registration number

CRD42019139326

Development and validation of multivariable clinical diagnostic models to identify type 1 diabetes requiring rapid insulin therapy in adults aged 18-50 years

Por: Lynam · A. · McDonald · T. · Hill · A. · Dennis · J. · Oram · R. · Pearson · E. · Weedon · M. · Hattersley · A. · Owen · K. · Shields · B. · Jones · A.
Objective

To develop and validate multivariable clinical diagnostic models to assist distinguishing between type 1 and type 2 diabetes in adults aged 18–50.

Design

Multivariable logistic regression analysis was used to develop classification models integrating five pre-specified predictor variables, including clinical features (age of diagnosis, body mass index) and clinical biomarkers (GADA and Islet Antigen 2 islet autoantibodies, Type 1 Diabetes Genetic Risk Score), to identify type 1 diabetes with rapid insulin requirement using data from existing cohorts.

Setting

UK cohorts recruited from primary and secondary care.

Participants

1352 (model development) and 582 (external validation) participants diagnosed with diabetes between the age of 18 and 50 years of white European origin.

Main outcome measures

Type 1 diabetes was defined by rapid insulin requirement (within 3 years of diagnosis) and severe endogenous insulin deficiency (C-peptide 600 pmol/L at ≥5 years diabetes duration). Model performance was assessed using area under the receiver operating characteristic curve (ROC AUC), and internal and external validation.

Results

Type 1 diabetes was present in 13% of participants in the development cohort. All five predictor variables were discriminative and independent predictors of type 1 diabetes (p

Conclusions

Clinical diagnostic models integrating clinical features with biomarkers have high accuracy for identifying type 1 diabetes with rapid insulin requirement, and could assist clinicians and researchers in accurately identifying patients with type 1 diabetes.

Feasibility of using a transition diabetes team to commence injectable therapies postdischarge from a tertiary hospital: a pilot, randomised controlled trial

Por: Pyrlis · F. · Ogrin · R. · Arthur · S. · Zhai · C. · Churilov · L. · Baqar · S. · Zajac · J. D. · Ekinci · E. I.
Objectives

This study aimed to investigate if the use of a transition team was feasible for patients with diabetes being discharged from hospital on injectable diabetes therapies.

Design

Pilot, randomised controlled trial.

Setting

The trial was conducted between 2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider.

Participants

Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to transition team or standard care. The transition team received in-home diabetes education 24–48 hours postdischarge, with endocrinologist review 2–4 weeks and 16 weeks postdischarge.

Main outcome measures

The primary outcome was feasibility, defined by percentage of patients successfully receiving the intervention. Secondary outcomes included safety, defined by hospital readmission and emergency department presentations within 16 weeks postrandomisation, and treatment satisfaction, measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS) and change in haemoglobin A1c (HbA1c) throughout the study.

Results

The intervention was deemed feasible (85% (95% CI 73% to 94%)). No difference in safety between groups was detected. No difference in change in HbA1c between groups was detected (standard care median HbA1c –1.5% (IQR –3.7% to –0.2%) vs transition team median HbA1c –1.9% (IQR –3.8% to –0.2%), p=0.83). There was a trend towards reduced LOS in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5–12); transition team median LOS 6 (IQR 3–12), p=0.06). There was a significant improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5–16); transition team DTSQ change version median 15 (IQR 10–17.5), p=0.047), although interpretability is limited by missing data.

Conclusion

This study demonstrated that the use of a novel transition diabetes team is a feasible alternative model of care.

Prevalence and risk factors for diabetic retinopathy in a cross-sectional population-based study from rural southern China: Dongguan Eye Study

Por: Cui · Y. · Zhang · M. · Zhang · L. · Zhang · L. · Kuang · J. · Zhang · G. · Liu · Q. · Guo · H. · Meng · Q.
Research question

The current population-based study aimed to investigate the prevalence of diabetic retinopathy (DR) and risk factors among residents over 40 years old in the rural area of Dongguan, southern China.

Study design

The Dongguan Eye Study was a population-based study from September 2011 to February 2012.

Setting

The area was set in the rural area of Dongguan, southern China.

Participants

Adult rural population aged 40 or older.

Intervention

Participants underwent haematological, physical, ophthalmic examinations and completed a questionnaire regarding lifestyles and systemic medical conditions.

Primary and secondary outcome measures

The frequency and risk factors of visual impairment and the major vision-threatening eye diseases.

Results

Of the 8952 Han Chinese, 1500 were diagnosed with type 2 diabetes mellitus (T2DM) with an average age of 59.5±11.1 years, and 1310 participants with fundus photography results were analysed. Standardised prevalence rate of DR was 18.2% for all patients with diabetes, 32.8% for the patients with previously diagnosed diabetes and 12.6% for newly diagnosed patients with T2DM. The prevalence rate of male DR was significantly higher than that of female DR (23.0% vs 14.1%, p

Conclusion

A relatively lower prevalence of DR was found among the participants with T2DM in residents over 40 years in the rural area of southern China. Thus, an ophthalmic examination is recommended, especially for individuals with DM and DR risk factors. There is a need to increase awareness and education on DM and DR, especially in subjects with DR risk factors to reduce the incidence of DR and macular oedema.

Effectiveness in clinical practice versus efficacy of dipeptidyl peptidase-4 inhibitors in clinical trials for type 2 diabetes: protocol for systematic review

Por: Batel-Marques · F. · Pereira · D. · Mendes · D. · Alves · C. · Penedones · A.
Introduction

Data supporting the use of oral antidiabetic drugs mainly rely on data from premarketing clinical trials. Real-world data studies are crucial to evaluate effectiveness of drugs. The aim of this systematic review is to compare the results obtained for efficacy and effectiveness endpoints on clinical trials and those obtained from routine clinical practice of dipeptidyl peptidase-4 inhibitors.

Methods and analysis

This systematic review will include randomised controlled trials and observational studies evaluating the efficacy and effectiveness of dipeptidyl peptidase-4 inhibitors, respectively. A literature search will be performed at Medline, Embase, Cochrane Controlled Register of Trials and ClinicalTrials.gov. Search terms comprised the drug name (including the pharmacotherapeutic class and the international non-proprietary name). Data on haemoglobin A1C, blood glucose and body weight will be retrieved. The risk of bias will be independently assessed according to the checklist proposed by Downs and Black. Data will be analysed using descriptive statistics and meta-analysis when applicable.

Ethics and dissemination

Ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication and at conference meetings.

Sex-specific prevalence, inequality and associated predictors of hypertension, diabetes, and comorbidity among Bangladeshi adults: results from a nationwide cross-sectional demographic and health survey

Por: Ali · N. · Akram · R. · Sheikh · N. · Sarker · A. R. · Sultana · M.
Objectives

To determine the sex-specific prevalence, inequality and factors associated with healthcare utilisation for diabetes mellitus (DM), hypertension and comorbidity among the adult population of Bangladesh.

Study design

This study analysed cross-sectional nationwide Bangladesh Demographic and Health Survey data from 2011. Comorbidity was defined as the coexistence of both DM and hypertension. Several socioeconomic and demographic factors such as age, sex, education, geographic location, administrative division, employment status, education and wealth index were considered as major explanatory variables. Inequality in prevalence and healthcare utilisation was measured using the ‘Lorenz curve’. Adjusted multiple logistic regression models were performed to observe the effects of different factors and reported as adjusted ORs (AORs) with 95% CIs. A p value of

Setting

The study was conducted in Bangladesh.

Participants

A total of 7521 adult participants with availability of biomarkers information were included.

Results

The mean age of the study participants was 51.4 years (SD ±13.0). The prevalence of hypertension, diabetes and comorbidity were 29.7%, 11.0% and 4.5% respectively. Socioeconomic inequality was observed in the utilisation of healthcare services. A higher prevalence of hypertension and comorbidity was significantly associated with individuals aged >70 years (AOR 7.0, 95% CI 5.0 to 9.9; AOR 6.7, 95% CI 3.0 to 14.9). The risk of having hypertension, diabetes and comorbidity were significantly higher among more educated, unemployed as well as among individuals from Khulna division.

Conclusions

The study revealed a rising prevalence of hypertension, diabetes and comorbidity with inequality in service utilisation. A joint effort involving public, private and non-governmental organisations is necessary to ensure improved accessibility in service utilisation and to reduce the disease burden.

Mortality and potential years of life lost attributable to non-optimal glycaemic control in men and women with diabetes in the United Arab Emirates: a population-based retrospective cohort study

Por: Al-Shamsi · S. · Govender · R. D. · Soteriades · E. S.
Objectives

Numerous studies reported that achieving near-normal glycated haemoglobin (HbA1c) levels in patients with diabetes may delay or even prevent vascular complications. However, information regarding the impact of non-optimal HbA1c control on adverse health outcomes in an Arab population is unknown. The aim of this study was to estimate the fraction of deaths and potential years of life lost (PYLL) attributable to non-optimal HbA1c control among Emirati men and women with diabetes in the United Arab Emirates (UAE).

Design

A retrospective cohort study.

Setting

This study was conducted in outpatient clinics at a tertiary care centre in Al Ain, UAE, between April 2008 and September 2018.

Participants

The sample comprised of 583 adult UAE nationals, aged≥18 years, with diabetes. Overall, 57% (n=332) of the study participants were men and 43% (n=251) were women.

Exposure

Non-optimal HbA1c control, defined as HbA1c≥6.5%.

Primary outcome measure

All-cause mortality, defined as death from any cause.

Results

At the end of the 9-year follow-up period, 86 (14.8%) participants died. Overall, up to 33% (95% CI 2% to 63%) of deaths were attributable to non-optimal HbA1c control among patients with diabetes mellitus (DM). Stratified by sex, the adjusted fraction of avoidable mortality was 17% (95% CI –23% to 57%) for men and 50% (95% CI 3% to 98%) for women. Both deaths and PYLL attributable to non-optimal HbA1c control were higher in women compared with men.

Conclusions

Up to one-third of all deaths in adult UAE nationals with DM could be attributed to non-optimal HbA1c control. Effective sex-specific interventions and healthcare quality-improvement programmes should urgently be implemented.

Analysis of English general practice level data linking medication levels, service activity and demography to levels of glycaemic control being achieved in type 2 diabetes to improve clinical practice and patient outcomes

Por: Heald · A. · Davies · M. · Stedman · M. · Livingston · M. · Lunt · M. · Fryer · A. · Gadsby · R.
Objective

Evaluate relative clinical effectiveness of treatment options for type 2 diabetes mellitus (T2DM) using a statistical model of real-world evidence within UK general practitioner practices (GPP), to quantify the opportunities for diabetes care performance improvement.

Method

From the National Diabetes Audit in 2015–2016 and 2016–2017, GPP target glycaemic control (TGC—%HbA1c ≤58 mmol/mol) and higher glycaemic risk (HGR —%HbA1c results >86 mmol/mol) outcomes were linked using multivariate linear regression to prescribing, demographics and practice service indicators. This was carried out both cross-sectionally (XS) (within year) and longitudinally (Lo) (across years) on 35 indicators. Standardised β coefficients were used to show relative level of impact of each factor. Improvement opportunity was calculated as impact on TGC & HGR numbers.

Results

Values from 6525 GPP with 2.7 million T2DM individuals were included. The cross-sectional model accounted for up to 28% TGC variance and 35% HGR variance, and the longitudinal model accounted for up to 9% TGC and 17% HGR variance. Practice service indicators including % achieving routine checks/blood pressure/cholesterol control targets were positively correlated, while demographic indicators including % younger age/social deprivation/white ethnicity were negatively correlated. The β values for selected molecules are shown as (increased TGC; decreased HGR), canagliflozin (XS 0.07;0.145/Lo 0.04;0.07), metformin (XS 0.12;0.04/Lo –;–), sitagliptin (XS 0.06;0.02/Lo 0.10;0.06), empagliflozin (XS–;0.07/Lo 0.09;0.07), dapagliflozin (XS –;0.04/Lo –;0.4), sulphonylurea (XS –0.18;–0.12/Lo–;–) and insulin (XS–0.14;0.02/ Lo–0.09;–). Moving all GPP prescribing and interventions to the equivalent of the top performing decile of GPP could result in total patients in TGC increasing from 1.90 million to 2.14 million, and total HGR falling from 191 000 to 123 000.

Conclusions

GPP using more legacy therapies such as sulphonylurea/insulin demonstrate poorer outcomes, while those applying holistic patient management/use of newer molecules demonstrate improved glycaemic outcomes. If all GPP moved service levels/prescribing to those of the top decile, both TGC/HGR could be substantially improved.

Association of diabetic retinopathy and diabetic macular oedema with renal function in southern Chinese patients with type 2 diabetes mellitus: a single-centre observational study

Por: Zhuang · X. · Cao · D. · Yang · D. · Zeng · Y. · Yu · H. · Wang · J. · Kuang · J. · Xie · J. · Zhang · S. · Zhang · L.
Background and objectives

The association of diabetic retinopathy (DR) and diabetic macular oedema (DME) with renal function in southern Chinese patients with diabetes is poorly understood. So we aimed to study the correlation between stage of DR and DME with stage of estimated glomerular filtration rate (eGFR) and stage of urine albumin-to-creatinine ratio (UACR), and to explore the systemic risk factors for DR and DME.

Design and setting

This single-centre retrospective observational study was conducted from December 2017 to November 2018.

Participants

413 southern Chinese patients with type 2 diabetes mellitus.

Outcome measures

The correlations between stage of DR and DME with stage of eGFR/UACR were assessed by Spearman’s or ² analyses and represented with histograms. Risk factors associated with the occurrence of DR and DME were performed by logistic regression and represented with nomograms.

Results

Stage of DR had a positive correlation with stage of eGFR (r=0.264, p

Conclusions

Among southern Chinese patients, stage of DR and DME were positively correlated with renal function, while stage of UACR performed a better relevance than stage of eGFR.

Open carpal tunnel release and diabetes: a retrospective study using PROMs and national quality registries

Por: Zimmerman · M. · Eeg-Olofsson · K. · Svensson · A.-M. · Aström · M. · Arner · M. · Dahlin · L.
Objectives

To study patient-reported outcome after open carpal tunnel release (OCTR) for carpal tunnel syndrome (CTS) in patients with or without diabetes using national healthcare quality registries.

Design

Retrospective cohort study.

Setting

Data from the Swedish National Quality Registry for Hand Surgery (HAKIR; www.hakir.se) were linked to data from the Swedish National Diabetes Register (NDR; www.ndr.nu).

Participants

We identified 9049 patients (10 770 hands) operated for CTS during the inclusion period (2010–2016).

Primary outcome measures

Patient-reported outcome measures were analysed before surgery and at 3 and 12 months postoperatively using the QuickDASH as well as the HAKIR questionnaire with eight questions on hand symptoms and disability.

Results

Patients with diabetes (n=1508; 14%) scored higher in the QuickDASH both preoperatively and postoperatively than patients without diabetes, but the total score change between preoperative and postoperative QuickDASH was equal between patients with and without diabetes. The results did not differ between patients with type 1 or type 2 diabetes. Patients with diabetic retinopathy scored higher in QuickDASH at 3 months postoperatively than patients with diabetes without retinopathy. In the regression analysis, diabetes was associated with more residual symptoms at 3 and 12 months postoperatively.

Conclusions

Patients with diabetes experience more symptoms both before and after OCTR, but can expect the same relative improvement from surgery as patients without diabetes . Patients with retinopathy, as a proxy for neuropathy, may need longer time for symptoms to resolve after OCTR. Smoking, older age, higher HbA1c levels and receiving a diabetes diagnosis after surgery were associated with more residual symptoms following OCTR.

Quality appraisal of clinical practice guidelines for diabetes mellitus published in China between 2007 and 2017 using the AGREE II instrument

Por: Gao · Y. · Wang · J. · Luo · X. · Song · X. · Liu · L. · Ke · L. · Liao · Z. · Wang · D. · Mu · Y. · Chen · Y. · Estill · J. A. M.
Objective

The aim of this study was to systematically evaluate the quality of the clinical practice guidelines (CPGs) for diabetes mellitus published in China over the period of January 2007 to April 2017.

Methods

We searched the China National Knowledge Infrastructure, Chinese Biomedical Literature database, VIP database and WanFang databases and guideline websites for CPGs for diabetes mellitus published between January 2007 and April 2017 in China. Two reviewers independently screened the literature according to the inclusion and exclusion criteria and extracted data. We used the the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool (Canadian Institutes of Health Research, Ottawa, Canada) to evaluate the quality of the included guidelines, calculated the scores of each domain and evaluated the consistency among the assessors via use of the intragroup correlation coefficient. And then we compared the results with Chinese CPGs and international CPGs. We conducted a subgroup analysis based on different classification criteria and compared scores of each domain subgroup analyses.

Results

A total of 98 guidelines were identified. The correlation coefficient within the group was 0.93, suggesting that the consistency between the evaluators was good. The scores of the six domains of AGREE II were described in median (IQR) as follows: scope and purpose 53.7 (50.0–59.7), stakeholder involvement 31.5 (27.3–37.0), rigour of development 19.1 (15.3–22.2), clarity of presentation 59.3 (50.0–64.8), applicability 18.1 (13.9–25.7) and editorial independence 0.0 (0.0–0.0). The mean score in each domain of quality of Chinese diabetes CPGs was lower than that of CPGs published worldwide but higher than the mean score of Chinese guidelines of all topics. A funding source, the updated version, organisation and publishers of the guidelines and target fields are all the factors influencing the quality of CPGs to a certain degree.

Conclusions

A large number of Chinese diabetes CPGs have been produced. Their quality remain unsatisfactorily low compared with CPGs worldwide, there is still room for improvement. Chinese guideline developers should pay more attention to the transparency of methodology, and use the AGREE II instrument to develop and report guidelines.

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