FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

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.

Effectiveness of strategies for nutritional therapy for patients with type 2 diabetes and/or hypertension in primary care: protocol of a systematic review of randomised controlled trials

Introduction

Despite the increasing number of drugs available and various guidelines on the management of type 2 diabetes mellitus (T2DM) and hypertension, an expressive number of patients continue with these diseases uncontrolled. Nutrition therapy (NT) plays a fundamental role in the prevention and management of these comorbidities, as well as in the prevention of complications related to them. The objective of this review is to evaluate the effectiveness of NT strategies in the management of patients with T2DM and/or hypertension in primary care. The selected strategies did not substitute pharmaceutical treatment but instead focused on preventing a sedentary lifestyle and stimulating healthy nutrition.

Methods and analysis

We will perform a systematic review according to Cochrane methodology of randomised controlled trials, wherein patients with T2DM and/or hypertension were allocated into one of the two groups: NT strategy, which may be of dietary quality or energy restriction, and conventional treatment. The primary outcomes will be glycaemic and blood pressure (BP) control, measured by final glycosylated hemoglobin (HbA1c) (%) and BP (mm Hg), respectively. Four general and adaptive search strategies have been created for the Embase, Medline, Latin American and Caribbean Health Sciences Literature (LILACS) and Cochrane Central Register of Controlled Trials (CENTRAL) electronic databases. Two reviewers will independently select eligible studies, assess the risk of bias and extract data from the included studies. Similar outcomes measured in at least two trials will be plotted in the meta-analysis using Review Manager V.5.3. The quality of evidence of the effect estimate of the intervention will be generated according to the Grading of Recommendations Assessment, Development, and Evaluation Working Group.

Ethics and dissemination

As no primary data collection will be undertaken, formal ethical assessment is not required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press.

PROSPERO registration number

Our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 December 2018 (Registration number CRD42018118117).

Diagnosis and treatment for hyperuricemia and gout: a systematic review of clinical practice guidelines and consensus statements

Por: Li · Q. · Li · X. · Wang · J. · Liu · H. · Kwong · J. S.-W. · Chen · H. · Li · L. · Chung · S.-C. · Shah · A. · Chen · Y. · An · Z. · Sun · X. · Hemingway · H. · Tian · H. · Li · S.
Objectives

Despite the publication of hundreds of trials on gout and hyperuricemia, management of these conditions remains suboptimal. We aimed to assess the quality and consistency of guidance documents for gout and hyperuricemia.

Design

Systematic review and quality assessment using the appraisal of guidelines for research and evaluation (AGREE) II methodology.

Data sources

PubMed and EMBASE (27 October 2016), two Chinese academic databases, eight guideline databases, and Google and Google scholar (July 2017).

Eligibility criteria

We included the latest version of international and national/regional clinical practice guidelines and consensus statements for diagnosis and/or treatment of hyperuricemia and gout, published in English or Chinese.

Data extraction and synthesis

Two reviewers independently screened searched items and extracted data. Four reviewers independently scored documents using AGREE II. Recommendations from all documents were tabulated and visualised in a coloured grid.

Results

Twenty-four guidance documents (16 clinical practice guidelines and 8 consensus statements) published between 2003 and 2017 were included. Included documents performed well in the domains of scope and purpose (median 85.4%, range 66.7%–100.0%) and clarity of presentation (median 79.2%, range 48.6%–98.6%), but unsatisfactory in applicability (median 10.9%, range 0.0%–66.7%) and editorial independence (median 28.1%, range 0.0%–83.3%). The 2017 British Society of Rheumatology guideline received the highest scores. Recommendations were concordant on the target serum uric acid level for long-term control, on some indications for urate-lowering therapy (ULT), and on the first-line drugs for ULT and for acute attack. Substantially inconsistent recommendations were provided for many items, especially for the timing of initiation of ULT and for treatment for asymptomatic hyperuricemia.

Conclusions

Methodological quality needs improvement in guidance documents on gout and hyperuricemia. Evidence for certain clinical questions is lacking, despite numerous trials in this field. Promoting standard guidance development methods and synthesising high-quality clinical evidence are potential approaches to reduce recommendation inconsistencies.

PROSPERO registration number

CRD42016046104.

Learning types and learning success in a structured diabetes education programme for patients with type 2 diabetes: study protocol of a prospective, longitudinal study

Por: Morro · T. · Fink · A. · Carmienke · S. · Frese · T. · Guenther · S.
Introduction

Diabetes mellitus (DM) has had a wide-ranging impact on healthcare politics. Secondary diseases and complications caused by diabetes are relevant cost and utilisation factors in the healthcare system. For decades, diabetes self-management education (DSME) has played a major role in the treatment of patients with type 2 DM (T2DM). The aim of this training is to empower patients to actively influence their diabetes process by gaining knowledge about health-related behaviours, such as healthy nutrition and exercise, and cardiovascular risks. The aim of the project is to analyse the practice of structured diabetes education and the effects of different learning types of participants. This project focuses on the needs of socioeconomically deprived patients and aims to improve DSME for this group. This patient group has a higher prevalence of T2DM, more complications and worse therapy-relevant parameters.

Methods and analysis

The study will be conducted as a prospective longitudinal study. Patients will be recruited in outpatient physician offices over a period of 12 months. Patients will be included if they are 18 years and older, have T2DM and are scheduled to participate in DSME for the first time. A pseudonymised, written survey with standardised questionnaires will be administered. The data will be analysed using inferential statistical methods, such as correlation analysis, regression models and variance analytical designs.

Ethics and dissemination

The study will be carried out following the principles of the Declaration of Helsinki and good scientific standards. Ethical approval of the Ethics Review Committee of the Medical Faculty at Martin-Luther-University, Halle-Wittenberg, was obtained. All participants in the study will receive comprehensive information and will be included after written informed consent is obtained. The results will be published in international peer-reviewed journals and presented at several congresses.

Trial registration number

DRKS00016630

Study protocol for a multicentre, controlled non-randomised trial: benefits of exercise physiology services for type 2 diabetes (BEST)

Por: Kitic · C. M. · Selig · S. · Davison · K. · Best · T. L. B. · Parmenter · B. · Pumpa · K. · Furzer · B. · Rice · V. · Hardcastle · S. · Cheney · M. · Palmer · A. J. · Fraser · S. · Williams · A. D.
Introduction

Controlled trials support the efficacy of exercise as a treatment modality for chronic conditions, yet effectiveness of real-world Exercise Physiology services is yet to be determined. This study will investigate the efficacy and cost-effectiveness of services provided by Accredited Exercise Physiologists (AEPs) for clients with type 2 diabetes (T2D) in clinical practice.

Methods and analysis

A non-randomised, opportunistic control, longitudinal design trial will be conducted at ten Exercise Physiology Clinics. Participants will be individuals with T2D attending one of the Exercise Physiology Clinics for routine AEP services (exercise prescription and counselling) (intervention) or individuals with T2D not receiving AEP services (usual care) (control). The experimental period will be 6 months with measurements performed at baseline and at 6 months. Primary outcome measures will be glycosylated haemoglobin (HbA1c), resting brachial blood pressure (BP), body mass index, waist circumference, 6 min walk test, grip strength, 30 s sit to stand, Medical Outcomes Short-Form 36-Item Health Survey and Active Australia Questionnaire. Secondary outcomes will be medication usage, out-of-pocket expenses, incidental, billable and non-billable health professional encounters and work missed through ill health. Healthcare utilisation will be measured for 12 months prior to, during and 12 months after trial participation using linked data from Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data.

Ethics and dissemination

The study is a multicentre trial comprising: University of Tasmania, University of New South Wales Lifestyle Clinic, University of Canberra, Baker Heart and Diabetes Institute (covered under the ethics approval of University of Tasmania Health and Medical Ethics Committee H0015266), Deakin University (Approval number: 2016–187), Australian Catholic University (2016–304R), Queensland University of Technology (1600000049), University of South Australia (0000035306), University of Western Australia (RA/4/1/8282) and Canberra Hospital (ETH.8.17.170). The findings of this clinical trial will be communicated via peer-reviewed journal articles, conference presentations, social media and broadcast media.

Trial registration number

ACTRN12616000264482.

Process evaluation of team-based care in people aged >65 years with type 2 diabetes mellitus

Por: Sims Gould · J. · Tong · C. · Ly · J. · Vazirian · S. · Windt · A. · Khan · K.
Objective

The prevalence of type 2 diabetes mellitus (T2DM) is increasing globally and there is critical need develop interventions to improve health outcomes among older people. The Group Appointments in Primary Care (GAP) study was a randomised controlled trial designed to test the efficacy of a group and team-based medical visit programme to lower haemoglobin A1c among patients with T2DM. We aimed to understand the barriers and facilitators to implement the GAP intervention within a primary care setting, with an emphasis on patient experience.

Research design and methods

This was a qualitative exploratory study. Data were gathered from semistructured interviews conducted with the first cohort of GAP study participants (n=15) at baseline and intervention completion. GAP participants were aged >65, diagnosed with T2DM and from one primary care clinic. The interview questions identified the patient perspectives and factors relating to their attendance at seven group medical visits that were part of the intervention programme. Data were analysed using framework analysis.

Results

We identified four themes that captured participants’ experiences: (1) Education: learning with professionals, learning with one another; (2) Social Support: common interests, common problems; (3) Setting: ease of location, ease of conversation and (4) Impact: expectations met, empowerment gained. The GAP intervention increased participants’ self-reported diabetes literacy and self-management skills.

Conclusions

We learnt that: accessible community centres, not primary care offices, were the ideal location for GAP; the consistent leadership of the primary care physician was valued by participants; and, the content related to exercise and healthy diet were viewed as impactful. Also, learning was achieved through content delivered by clinical experts, and by T2DM experts with lived experience—the GAP peers. Our findings highlight the important role of group learning.

Trial registration number

NCT02002143

Diabetes-related symptoms, acute complications and management of diabetes mellitus of patients who are receiving palliative care: a protocol for a systematic review

Por: Bettencourt-Silva · R. · Aguiar · B. · Sa-Araujo · V. · Barreira · R. · Guedes · V. · Marques Ribeiro · M. J. · Carvalho · D. · Östlundh · L. · Paulo · M. S.
Introduction

Worldwide, an estimated 40 million people are in need of palliative care each year, but only 14% receive it. The incidence of diabetes mellitus (DM) in patients receiving palliative care is higher than in the general population. This association is intended to grow as a result of the rising burden of DM worldwide, ageing populations and the improved overall survival time of several diseases over the last few decades. Recommendations for DM management in the context of palliative care are mainly based on expert opinion as there is a lack of suitable evidence base and randomised clinical trials in palliative care are scarce. The aim of our systematic review is to identify the best DM management practices in order to reduce important DM-related symptoms and acute complications in patients receiving palliative care.

Methods and analysis

The authors will study the DM treatment and management literature, surveying the different approaches employed to treat adult palliative patients. Core health bibliographic databases will be searched from January 1990 to May 2019. Data sources will include Ovid MEDLINE, Embase, PubMed, Web of Sciences, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, Cumulative Index to Nursing and Allied Health Literature and grey literature. Details regarding diet, oral and injectable glucose-lowering medicines, insulin regimens and blood glucose monitoring strategies will be evaluated. We defined the primary outcomes to compare between DM management approaches as the presence of symptoms (polyuria, polydipsia and polyphagia) and acute complications of DM (hypoglycaemia, hyperglycaemic hyperosmolar state and diabetic ketoacidosis), and secondary outcomes as hospital admissions and deaths due to DM-related complications, health-related quality of life and glycaemic control.

Ethics and dissemination

The systematic review methodology does not require ethics approval due to the nature of the study design. The results of the systematic review will be published in a peer-reviewed journal and will be publicly available.

PROSPERO registration number

CRD42018115772.

Assessment of the methodological quality of local clinical practice guidelines on the identification and management of gestational diabetes

Por: Daley · B. · Hitman · G. · Fenton · N. · McLachlan · S.
Objective

Gestational diabetes is the most common metabolic disorder of pregnancy, and it is important that well-written clinical practice guidelines (CPGs) are used to optimise healthcare delivery and improve patient outcomes. The aim of the study was to assess the methodological quality of hospital-based CPGs on the identification and management of gestational diabetes.

Design

We conducted an assessment of local clinical guidelines in English for gestational diabetes using the Appraisal of Guidelines for Research and Evaluation (AGREE II) to assess and validate methodological quality.

Data sources and eligibility criteria

We sought a representative selection of local CPGs accessible by the internet. Criteria for inclusion were (1) identified as a guideline, (2) written in English, (3) produced by or for the hospital in a Western country, (4) included diagnostic criteria and recommendations concerning gestational diabetes, (5) grounded on evidence-based medicine and (6) accessible over the internet. No more than two CPGs were selected from any single country.

Results

Of the 56 CPGs identified, 7 were evaluated in detail by five reviewers using the standard AGREE II instrument. Interrater variance was calculated, with strong agreement observed for those protocols considered by reviewers as the highest and lowest scoring based on the instrument. CPG results for each of the six AGREE II domains are presented categorically using a 5-point Likert scale. Only one CPG scored above average in five or more of the domains. Overall scores ranged from 91.6 (the strongest) to 50 (the weakest). Significant variation existed in the methodological quality of CPGs, even though they followed the guideline of an advising body. Specifically, appropriate identification of the evidence relied on to inform clinical decision making in CPGs was poor, as was evidence of user involvement in the development of the guideline, resource implications, documentation of competing interests of the guideline development group and evidence of external review.

Conclusions

The limitations described are important considerations for updating current and new CPGs.

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and {beta}-cell function in subjects with morbid obesity: a prot

Por: Borgeraas · H. · Hjelmesaeth · J. · Birkeland · K. I. · Fatima · F. · Grimnes · J. O. · Gulseth · H. L. · Halvorsen · E. · Hertel · J. K. · Hillestad · T. O. W. · Johnson · L. K. · Karlsen · T.-I. · Kolotkin · R. L. · Kvan · N. P. · Lindberg · M. · Lorentzen · J. · Nordstrand · N. · Sa
Introduction

Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function.

Methods and analysis

Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrectomy. The primary outcome measures are (1) the proportion of participants with complete remission of type 2 diabetes (HbA1c≤6.0% in the absence of blood glucose-lowering pharmacologic therapy) and (2) β-cell function expressed by the disposition index (calculated using the frequently sampled intravenous glucose tolerance test with minimal model analysis) 1 year after surgery.

Ethics and dissemination

The protocol of the current study was reviewed and approved by the regional ethics committee on 12 September 2012 (ref: 2012/1427/REK sør-øst B). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences. Participants will receive a summary of the main findings.

Trial registration number

NCT01778738;Pre-results.

Protocol for the Gut Bugs Trial: a randomised double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents

Por: Leong · K. S. W. · Jayasinghe · T. N. · Derraik · J. G. B. · Albert · B. B. · Chiavaroli · V. · Svirskis · D. M. · Beck · K. L. · Conlon · C. A. · Jiang · Y. · Schierding · W. · Vatanen · T. · Holland · D. J. · OSullivan · J. M. · Cutfield · W. S.
Introduction

Animal studies showed that germ-free mice inoculated with normal mouse gut bacteria developed obesity, insulin resistance and higher triglyceride levels, despite similar food intake. In humans, an association has been found between obesity and gut microbiome dysbiosis. However, gut microbiome transfer has not been evaluated for the treatment of human obesity. We will examine the effectiveness of gut microbiome transfer using encapsulated material for the treatment of obesity in adolescents.

Methods and analysis

A two-arm, double-blind, placebo-controlled, randomised clinical trial of a single course of gut microbiome transfer will be conducted in 80 obese [body mass index (BMI) ≥30 kg/m2] adolescents (males and females, aged 14–18 years) in Auckland, New Zealand. Healthy lean donors (males and females, aged 18–28 years) will provide fresh stool samples from which bacteria will be isolated and double encapsulated. Participants (recipients) will be randomised at 1:1 to control (placebo) or treatment (gut microbiome transfer), stratified by sex. Recipients will receive 28 capsules over two consecutive mornings (~14 mL of frozen microbial suspension or saline). Clinical assessments will be performed at baseline, 6, 12 and 26 weeks, and will include: anthropometry, blood pressure, fasting metabolic markers, dietary intake, physical activity levels and health-related quality of life. Insulin sensitivity (Matsuda index), gut microbiota population structure characterised by 16S rRNA amplicon sequencing and body composition (using dual-energy X-ray absorptiometry) will be assessed at baseline, 6, 12 and 26 weeks. 24-hour ambulatory blood pressure monitoring will be performed at baseline and at 6 weeks. The primary outcome is BMI SD scores (SDS) at 6 weeks, with BMI SDS at 12 and 26 weeks as secondary outcomes. Other secondary outcomes include insulin sensitivity, adiposity (total body fat percentage) and gut microbial composition at 6, 12 and 26 weeks. Statistical analysis will be performed on the principle of intention to treat.

Ethics and dissemination

Ethics approval was provided by the Northern A Health and Disability Ethics Committee (Ministry of Health, New Zealand; 16/NTA/172). The trial results will be published in peer-reviewed journals and presented at international conferences.

Trial registration number

ACTRN12615001351505; Pre-results.

Cost and cost-effectiveness of mHealth interventions for the prevention and control of type 2 diabetes mellitus: a protocol for a systematic review

Por: Rinaldi · G. · Hijazi · A. · Haghparast-Bidgoli · H.
Introduction

Type 2 diabetes mellitus (T2DM) remains one of the most common chronic diseases of adulthood which creates high degrees of morbidity and mortality worldwide. The incidence of T2DM continues to rise and recently, mHealth interventions have been increasingly used in the prevention, monitoring and management of T2DM. The aim of this study is to systematically review the published evidence on cost and cost-effectiveness of mHealth interventions for T2DM, as well as assess the quality of reporting of the evidence.

Methods and analysis

A comprehensive review of PubMed, EMBASE, Science Direct and Web of Science of articles published until January 2019 will be conducted. Included studies will be partial or full economic evaluations which provide cost or cost-effectiveness results for mHealth interventions targeting individuals diagnosed with, or at risk of, T2DM. The quality of reporting evidence will be assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results will be presented using a flowchart following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Graphical and tabulated representations of the results will be created for both descriptive and numerical results. The cost and cost-effectiveness values will be presented as reported by the original studies as well as converted into international dollars to allow comparability. As we are predicting heterogenous results, we will conduct a narrative and interpretive analysis of the data.

Ethics and dissemination

No formal approval or review of ethics is required for this systematic review as it will involve the collection and analysis of secondary data. This protocol follows the current PRISMA-P guidelines. The review will provide information on the cost and cost-effectiveness of mHealth interventions targeting T2DM. These results will be disseminated through publication and submission to conferences for presentations and posters.

PROSPERO registration number

CRD42019123476

Comparative long-term effectiveness and safety of primary bariatric surgeries in treating type 2 diabetes mellitus in adults: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Ding · L. · Zhuo · C. · Fan · Y. · Zhang · Y. · Li · H. · Qi · D. · Tang · S. · Cui · J. · He · Q. · Liu · M.
Introduction

Bariatric surgeries are effective in treating obesity related comorbidities, including type 2 diabetes mellitus. More robust evidence is needed to facilitate choice of procedure. In this systemic review, we aim to investigate the comparative long-term effectiveness in inducing remission of type 2 diabetes, halting diabetic complications, reducing mortality and the safety of conventional and emerging bariatric surgeries.

Methods and analysis

Databases including Cochrane Central Register, EMBASE, MEDLINE and clinical trial registries will be searched for randomised controlled trials with at least 3 years of follow-up, including direct and/or indirect evidence regarding primary bariatric surgeries in overweight or obese adults with type 2 diabetes mellitus, from inception of each database to 2019, with no language or publication type limits imposed. Dual selection of studies, data extraction and risk of bias assessments will be performed. Primary outcomes include full diabetes remission, composite outcome of full or partial diabetes remission and adverse event profiles. Secondary outcomes include anthropometric measurements, cardiovascular risk factor burden, medication burden, diabetic complications and all-cause mortality. Given sufficient homogeneity, network meta-analyses will be performed in a random-effects model based on the Bayesian framework, while assessing for consistency between direct and indirect estimates. Heterogeneities of studies will be explored through meta-regression analysis, and robustness of findings will be checked by sensitivity analysis, and an alternative method under a frequentist framework. All statistical analysis and graphical presentations will be conducted by R software V.3.3.3 (The R Project for Statistical Computing). The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation criteria for each outcome.

Ethics and dissemination

Ethics approval is not required as individual patient data will not be included. This review will be subject for publication in a peer reviewed journal.

PROSPERO registration number

CRD42018110775.

Tibial nerve decompression for the prevention of the diabetic foot: a cost-utility analysis using Markov model simulations

Por: Sarmiento · S. · Pierre Jr · J. A. · Dellon · A. L. · Frick · K. D.
Objective

To determine whether tibial neurolysis performed as a surgical intervention for patients with diabetic neuropathy and superimposed tibial nerve compression in the prevention of the diabetic foot is cost-effective when compared with the current prevention programme.

Design

A baseline analysis was built on a 5-year model to determine the cumulative incidence of foot ulcers and amputations with each strategy. Subsequently, a cost-effectiveness analysis and cohort-level Markov simulations were conducted with a model composed of 20 6-month cycles. A sensitivity analysis was also performed.

Setting

A Markov model was used to simulate the effects of standard prevention compared with tibial neurolysis on the long-term costs associated with foot ulcers and amputations. This model included eight health states.

Participants

Each cohort includes simulated patients with diabetic neuropathy at different levels of risk of developing foot ulcers and amputations.

Primary and secondary outcome measures

The primary outcome was the long-term trends concerning the development of ulcers and amputations with each strategy. The secondary outcome measures were quality adjusted life years (QALYs), incremental cost-effectiveness and net monetary benefits of the optimal strategy.

Results

When compared with standard prevention, for a patient population of 10 000, surgery prevented a simulated total of 1447 ulcers and 409 amputations over a period of 5 years. In a subsequent analysis that consisted of 20 6-month cycles (10 years), the incremental cost of tibial neurolysis compared with current prevention was $12 772.28; the incremental effectiveness was 0.41 QALYs and the incremental cost-effectiveness ratio was $31 330.78. Survival was 73% for those receiving medical prevention compared with 95% for those undergoing surgery.

Conclusion

These results suggest that among patients with diabetic neuropathy and superimposed nerve compression, surgery is more effective at preventing serious comorbidities and is associated with a higher survival over time. It also generated greater long-term economic benefits.

Association between full monitoring of biomedical and lifestyle target indicators and HbA1c level in primary type 2 diabetes care: an observational cohort study (ELZHA-cohort 1)

Por: van Bruggen · S. · Rauh · S. P. · Kasteleyn · M. J. · Bonten · T. N. · Chavannes · N. H. · Numans · M. E.
Objective

Management of type 2 diabetes mellitus (T2DM) requires frequent monitoring of patients. Within a collective care group setting, doubts on the clinical effects of registration are a barrier for full adoption of T2DM registration in general practice. We explored whether full monitoring of biomedical and lifestyle-related target indicators within a care group approach is associated with lower HbA1c levels.

Design

Observational, real-life cohort study.

Setting

Primary care data registry from the Hadoks (EerstelijnsZorggroepHaaglanden) care group.

Exposure

The care group provides general practitioners collectively with organisational support to facilitate structured T2DM primary care. Patients are offered quarterly medical and lifestyle-related consultation.

Main outcome measure

Full monitoring of each target indicator in patients with T2DM which includes minimally one measure of HbA1c level, systolic blood pressure, LDL, BMI, smoking behaviour and physical exercise between January and December 2014; otherwise, patients were defined as ’incompletely monitored'. HbA1c levels of 8137 fully monitored and 3958 incompletely monitored patients were compared, adjusted for the confounders diabetes duration, age and gender. Since recommended HbA1c values depend on age, medication use and diabetes duration, analyses were stratified into three HbA1c profile groups. Linear multilevel analyses enabled adjustment for general practice.

Results

Compared with incompletely monitored patients, fully monitored patients had significantly lower HbA1c levels (95% CI) in the first (–2.03 [–2.53 to –1.52] mmol/mol) (–0.19% [–0.23% to –0.14%]), second (–3.36 [–5.28 to –1.43] mmol/mol) (–0.31% [–0.48% to –0.13%]) and third HbA1c profile group (–1.89 [–3.76 to –0.01] mmol/mol) (–0.17% [–0.34% to 0.00%]).

Conclusions/interpretation

This study shows that in a care group setting, fully monitored patients had significantly lower HbA1c levels compared with incompletely monitored patients. Since this difference might have considerable clinical impact in terms of T2DM-related risks, this might help general practices in care group settings to overcome barriers on adequate registration and thus improve structured T2DM primary care. From population health management perspective, we recommend a systematic approach to adjust the structured care protocol for incompletely monitored subgroups.

Sex differences and correlates of poor glycaemic control in type 2 diabetes: a cross-sectional study in Brazil and Venezuela

Por: G Duarte · F. · da Silva Moreira · S. · Almeida · M. d. C. C. · de Souza Teles · C. A. · Andrade · C. S. · Reingold · A. L. · Moreira Jr · E. D.
Objective

Examine whether glycaemic control varies according to sex and whether the latter plays a role in modifying factors associated with inadequate glycaemic control in patients with type 2 diabetes (T2D) in Brazil and Venezuela.

Design, setting and participants

This was a cross-sectional, nationwide survey conducted in Brazil and Venezuela from February 2006 to June 2007 to obtain information about glycaemic control and its determinants in patients with diabetes mellitus attending outpatient clinics.

Main outcome measures

Haemoglobin A1c (HbA1c) level was measured by liquid chromatography, and patients with HbA1c ≥7.0% (53 mmol/mol) were considered to have inadequate glycaemic control. The association of selected variables with glycaemic control was analysed by multivariate linear regression, using HbA1c as the dependent variable.

Results

A total of 9418 patients with T2D were enrolled in Brazil (n=5692) and in Venezuela (n=3726). They included 6214 (66%) women and 3204 (34%) men. On average, HbA1c levels in women were 0.13 (95% CI 0.03 to 0.24; p=0.015) higher than in men, after adjusting for age, marital status, education, race, country, body mass index, duration of disease, complications, type of healthcare, adherence to diet, adherence to treatment and previous measurement of HbA1c. Sex modified the effect of some factors associated with glycaemic control in patients with T2D in our study, but had no noteworthy effect in others.

Conclusions

Women with T2D had worse glycaemic control than men. Possible causes for poorer glycaemic control in women compared with men include differences in glucose homeostasis, treatment response and psychological factors. In addition, sex modified factors associated with glycaemic control, suggesting the need to develop specific treatment guidelines for men and women.

Global prevalence of diabetic retinopathy: protocol for a systematic review and meta-analysis

Por: Cheloni · R. · Gandolfi · S. A. · Signorelli · C. · Odone · A.
Introduction

With increasing diabetes trends worldwide, morbidity, mortality and associated costs due to diabetes-related complications are a global public health concern. Diabetic retinopathy (DR) is among the leading causes of vision loss at the global level; accurate estimates of DR burden is of crucial importance for planning, implementing and evaluating DR prevention and care interventions.

The available evidence on DR prevalence at the global level, dating back to 2008, only considered data from selected regions. Taking into account the rapidly changing patterns in DR epidemiology, the aim of the current study is to carry out a systematic review and meta-analysis to derive solid and updated estimates on global and setting-specific DR prevalence.

Methods and analysis

The systematic review methods have been defined following PRISMA guidelines. Studies published from 2008 through 2018 will be identified searching the electronic databases Embase, Medline, Cochrane, ISI Web of Knowledge, as well as through grey literature search. Retrieved records will be independently screened by two authors and relevant data will be extracted from studies reporting data on DR prevalence among individuals with diabetes. Prevalence pooled estimates of any form of DR and vision-threatening DR will be computed applying random-effects meta-analysis. Interstudy heterogeneity will be assessed using the I2 statistic and explored through meta regressions and subgroup analyses. Depending on data availability, we plan to conduct subgroup analyses by study population, diabetes type, DR severity, geographical region and other selected clinical and sociodemographic variables of interest. Quality appraisal of the studies will be performed.

Ethics and dissemination

Ethics approval is not required as this is a review of anonymised published data. Findings of the final report will be shared with the scientific community through publication in a peer-reviewed journal and presentation at conferences, as well as with key stakeholders, including national and international health authorities, health policy makers, healthcare professionals and the general population.

Clinical trial registration

CRD42018085260.

Treatment patterns, persistence and adherence rates in patients with type 2 diabetes mellitus in Japan: a claims-based cohort study

Por: Nishimura · R. · Kato · H. · Kisanuki · K. · Oh · A. · Hiroi · S. · Onishi · Y. · Guelfucci · F. · Shimasaki · Y.
Objective

To determine real-world trends in antidiabetic drug use, and persistence and adherence, in Japanese patients with type 2 diabetes mellitus (T2DM).

Design

Retrospective evaluation of administrative claims data (2011–2015) using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases.

Setting

Analysis of two administrative claims databases for Japanese patients with T2DM.

Participants

Adults (aged ≥18 years) with an International Classification of Diseases, 10th Revision code of T2DM and at least one antidiabetic drug prescription.

Main outcome measures

Treatment patterns in untreated (UT) or previously treated (PT) patients receiving antidiabetic therapy; persistence with treatment at 12 months; adherence to treatment at 12 months.

Results

40 908 and 90 421 patients were included from the JMDC and MDV databases, respectively. The most frequently prescribed therapy at the index (first prescription) date was dipeptidyl peptidase-4 inhibitor (DPP-4i) in UT patients (JMDC: 44.0%, MDV: 54.8%) and combination therapy in PT patients (74.6%, 81.1%). Most common combinations were DPP-4i plus: biguanide (BG; 11.4%, 10.9%), sulfonylurea (SU; 8.4%, 11.0%) or BG+SU (7.8%, 9.1%). In UT or PT patients from either database whose index prescription was for any antidiabetic drug class(es) other than DPP-4i, the most frequent add-on or switch was to DPP-4i. 12-month persistence with index monotherapy was highest with DPP-4i and BG. Adherence was high (≥80%) for all monotherapy schedules, except insulin and glucagon-like peptide-1 agonist, and for the five most frequent two-drug and three-drug combinations. Persistence was greater in elderly UT patients and in those receiving ≤5 medications, but comparatively worse in UT patients with ≥3 index antidiabetic drug classes.

Conclusions

The findings indicate that DPP-4i is the most commonly used antidiabetic drug class in Japanese patients with T2DM, and persistence and adherence to this antidiabetic drug class are high.

Sleep duration and apolipoprotein B in metabolically healthy and unhealthy overweight/obese phenotypes: a cross-sectional study in Chinese adults

Por: Ren · H. · Zhang · L. · Liu · Z. · Zhou · X. · Yuan · G.
Objectives

Short sleep duration is independently associated with an increased risk of developing cardiovascular disease; however, the association has not yet been examined in obese populations. We assessed the associations between sleep duration, metabolic phenotype and apolipoprotein variables in a nationally representative Chinese population with overweight/obesity.

Study design

Cross-sectional study.

Settings

The study conducted in nine provinces of China that vary substantially in geography and economic development.

Patients

Data were obtained from 4149 adults with overweight/obesity aged 18 to 94 years from the 2009 China Health and Nutrition Survey. Sleep duration was categorised as ≤6, 7–8 or ≥9 hour. Phenotypes were determined based on body mass index and metabolic health status and categorised as metabolically healthy overweight/obesity (MHOO) and metabolically unhealthy overweight/obesity (MUOO).

Main outcome measure

The outcome variables were elevated apolipoproteins.

Results

Compared with MHOO phenotype, MUOO phenotypes were more likely to report shorter sleep duration (12.2%vs9%). In the MUOO group, the multivariate-adjusted OR (95% CI) for elevated apolipoprotein B (apoB) was 1.66 (1.23 to 2.23) for those with ≤6 hours of sleep and 1.12 (0.86 to 1.45) for those with ≥9 hours of sleep, using 7–8 hours of sleep as a reference. Similar results were obtained in the subgroup of subjects who were ≥45 or

Conclusions

The high prevalence of short sleep duration and its strong association with elevated apoB in adults who are metabolically unhealthy overweight/obese suggest an increased risk of cardiovascular disease in this population. The differences in sleep sufficiency among obese phenotypes may account for the disparities in their cardiovascular outcomes.

Pregnancy outcomes of early detected gestational diabetes: a retrospective comparison cohort study, Qatar

Por: Bashir · M. · Baagar · K. · Naem · E. · Elkhatib · F. · Alshaybani · N. · Konje · J. C. · Abou-Samra · A.-B.
Objective

To compare pregnancy outcomes in patients with early versus usual gestational diabetes mellitus (GDM).

Design

A retrospective cohort study.

Settings

The Women’s Hospital, Hamad Medical Corporation, Qatar.

Participants

GDM women who attended and delivered in the Women’s Hospital, between January and December 2016. GDM was diagnosed based on the 2013-WHO criteria. The study included 801 patients; of which, 273 E-GDM and 528 U-GDM. Early GDM (E-GDM) and usual GDM (U-GDM) were defined as GDM detected before and after 24 weeks’ gestation, respectively.

Outcomes

Maternal and neonatal outcomes and the impact of timing of GDM-diagnosis on pregnancy outcomes.

Results

At conception, E-GDM women were older (mean age 33.5±5.4 vs 32.0±5.4 years, p2, p=0.0059) compared with U-GDM. The mean fasting, and 1-hour blood glucose levels were significantly higher in E-GDM vs U-GDM, respectively (5.3±0.7 vs 4.0±0.7 mmol/L, p

Conclusion

Our data support the concept of early screening and treatment of GDM in high-risk patients. More data are needed to examine the optimal time for screening.

❌