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Background Most adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care (“family supporters”). These family supporters are an important resource who could be leveraged to improve patients’ engagement in their care and patient health outcomes. However, healthcare teams lack structured and feasible approaches to effectively engage family supporters in patient self-management support. This trial tests a strategy to strengthen the capacity of family supporters to help adults with high-risk diabetes engage in healthcare, successfully enact care plans, and lower risk of diabetes complications. Methods/design We will conduct a randomized trial evaluating the CO-IMPACT (Caring Others Increasing EnageMent in Patient Aligned Care Teams) intervention. Two hunded forty adults with diabetes who are at high risk for diabetes complications due to poor glycemic control or high blood pressure will be randomized, along with a family supporter (living either with the patient or remotely), to CO-IMPACT or enhanced usual primary care for 12 months. CO-IMPACT provides patient-supporter dyads: it provides one coaching session addressing supporter techniques for helping patients with behavior change motivation, action planning, and proactive communication with healthcare providers; biweekly automated phone calls to prompt dyad action on new patient health concerns; phone calls to prompt preparation for patients’ primary care visits; and primary care visit summaries sent to both patient and supporter. Primary outcomes are changes in patient activation, as measured by the Patient Activation Measure-13, and change in 5-year cardiac event risk, as measured by the United Kingdom Prospective Diabetes Study cardiac risk score for people with diabetes. Secondary outcomes include patients’ diabetes self-management behaviors, diabetes distress, and glycemic and blood pressure control. Measures among supporters will include use of effective support techniques, burden, and distress about patient’s diabetes care. Discussion If effective in improving patient activation and diabetes management, CO-IMPACT will provide healthcare teams with evidence-based tools and techniques to engage patients’ available family or friends in supporting patient self-management, even if they live remotely. The core skills addressed by CO-IMPACT can be used by patients and their supporters over time to respond to changing patient health needs and priorities. Trial registration ClinicalTrials.gov, NCT02328326 . Registered on 31 December 2014.

Background We aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy. Method A 12-month single blinded multicenter randomized control trial was designed to investigate the measured variables [Glycated Hemoglobin (HbA1c), Renal function, Albumin Creatinine Ratio (ACR) etc.]. The trial was randomized into 2 experimental parallel arms (ascorbic acid vs acetylsalicylic acid) were blinded with study supplements in combination with metformin and findings were compared to control arm with metformin alone and blinded with placebo. Withdrawal criteria was defined to maintain the equity and balance in the participants in the whole trial. Finding Patients with metformin and ascorbic acid (parallel arm I) was twice more likely to reduce HbA1c than metformin alone (control arm) in a year (OR 2.31 (95% CI 1.87–4.42) p  < 0.001). Also Parallel arm I was ten times more likely to reduced risk factors contributing to long-term diabetes complications than participants of arm II in a year (OR 10.38 (95% CI 6.91–15.77) p  < 0.001). In contrast, parallel arm II patients were seven times more effective to reduce the risk of expected CVD development in 10 years than arm I (OR 7.54 (95% CI 3.76–10.32) p  < 0.001). Conclusions The trial concluded that ascorbic acid with metformin is more effective against reducing risks for diabetes related long-term complications (including ACR). TRIAL details Registration No: NTR-6100, Registry Name: Netherlands Trial Registry, URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6100 , Date of Registration: 20th October, 2016, Date of first Enrollment: 1 November, 2015.

Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

Background Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care. Methods DYNAMIT was a prospective, randomized, open, blinded end-point multicenter trial run between 2000 and 2005, with a 3.5 year mean follow-up in ambulatory care in 45 French hospitals. The study included 631 male and female with diabetes aged 63.9 ± 5.1 years, with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors, receiving appropriate medical treatment. The patients were randomized centrally to either screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N = 316), or follow-up without screening (N = 315). The main study end point was time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention. The results of a meta-analysis of DYNAMIT and DIAD, a similar study, are also presented. Results The study was discontinued prematurely because of difficulties in recruitment and a lower-than expected event rate. Follow-up was complete for 98.9% patients regarding mortality and for 97.5% regarding the main study end point. Silent ischemia detection procedure was positive or uncertain in 68 (21.5%) patients of the screening group. There was no significant difference between the screening and the usual care group for the main outcome (hazard ratio = 1.00 95%CI 0.59 to 1.71). The meta-analysis of these and DIAD results gave similar results, with narrower confidence intervals for each endpoint. Conclusions These results suggest that the systematic detection of silent ischemia in high-risk asymptomatic patients with diabetes is unlikely to provide any major benefit on hard outcomes in patients whose cardiovascular risk is controlled by an optimal medical treatment. Trial registration ClinicalTrials.gov: NCT00627783

Background Erectile dysfunction is an inability to initiate and have a persistent erection firm enough to have satisfying sexual intercourse. The prevalence of erectile dysfunction in diabetic men is considerably high, but it is often underdiagnosed and under-managed. Objective This study aimed to determine erectile dysfunction and associated factors among diabetic patients at, Hawassa, Southern, Ethiopia. Methods The institution-based cross-sectional study was conducted on 352 adult male diabetic patients randomly selected from Adare general and Hawassa comprehensive specialized hospitals using a simple random sampling technique. The number of patients to be selected from each hospital was proportionally assigned based on the total population of diabetes mellitus patients following chronic care during the study period. The descriptive statistics and multiple logistic regressions (bivariate and multivariate analysis) were carried out. Result The prevalence of erectile dysfunction was 72.2% (95%CI, 1.76–3.68). After adjusting all factors, old age, diabetes duration, drinking alcohol, and poor glycemic control had shown significant association with erectile dysfunction. Conclusion The occurrence of erectile dysfunction in this study community is very high. Drinking alcohol, poor glycemic control, age, and duration of diabetes were predictors of erectile dysfunction in this study area. Assessment and management of erectile dysfunction in the diabetic clinic should be part of routine medical care during follow-up visits with diabetic patients. Healthcare providers should emphasize screening and treating older patients and those who have had a diabetes diagnosis for a longer duration.

Aims/Introduction As estimated glomerular filtration rate (eGFR) progression might correlate with cardiovascular prognosis, the correlation between 1‐year decline in eGFR and cardiovascular incidences and renal outcome was investigated. Materials and Methods The 1‐year percentage decline in eGFR at the first observation year was calculated in a cohort of the standard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) trial participants. The primary end‐point was the composite cardiovascular end‐point including the renal end‐point. The associations between the incidence of each end‐point and clinical markers were analyzed using the Cox proportional hazards regression model. Results A total of 4,461 patients were analyzed. The mean observation period was 765.3 ± 363.1 days. The best cut‐off value of 1‐year eGFR decline was 0.099 in the first year for renal end‐point prediction by receiver operating characteristic curve analysis. The area under the curve of the model including the 1‐year eGFR decline of the first year was significantly larger than the model without it (0.943, 95% confidence interval 0.915–0.971 to 0.967, 95% confidence interval 0.950–0.983, P = 0.019). Primary end‐point incidences and the renal end‐point were much higher in rapid eGFR decliners compared with non‐decliners (P < 0.0001). The cardiovascular end‐point incidence, except for the renal end‐point, was not different between the groups. According to Cox regression analysis, 1‐year eGFR decline during the first year was a significant risk factor for the end‐points, including the renal end‐point, independent of albuminuria and eGFR at baseline. Conclusions The 1‐year eGFR decline rate provided useful information for cardiovascular end‐point predictions, including the renal end‐point, in addition to the conventional risk factors. Primary end‐point incidences and renal end‐point were much higher in rapid estimated glomerular filtration rate decliners compared with non‐decliners (P < 0.0001). According to Cox regression analysis, 1‐year estimated glomerular filtration rate decline during the first year was a significant risk factor for the end‐points, including the renal end‐point, independent of albuminuria and estimated glomerular filtration rate at baseline.

Aims/hypothesis This study is a 19 year observational follow-up of a pragmatic open multicentre cluster-randomised controlled trial of 6 years of structured personal diabetes care starting from diagnosis. Methods A total of 1,381 patients aged ≥40 years and newly diagnosed with type 2 diabetes were followed up in national registries for 19 years. Clinical follow-up was at 6 and 14 years after diabetes diagnosis. The original 6 year intervention included regular follow-up and individualised goal setting, supported by prompting of doctors, clinical guidelines, feedback and continuing medical education (ClinicalTrials.gov NCT01074762). The registry-based endpoints were: incidence of any diabetes-related endpoint; diabetes-related death; all-cause mortality; myocardial infarction (MI); stroke; peripheral vascular disease; and microvascular disease. Results At 14 year clinical follow-up, group differences in risk factors from the 6 year follow-up had levelled out, although the prevalence of (micro)albuminuria and level of triacylglycerols were lower in the intervention group. During 19 years of registry-based monitoring, all-cause mortality was not different between the intervention and comparison groups (58.9 vs 62.3 events per 1,000 patient-years, respectively; for structured personal care, HR 0.94, 95% CI 0.83, 1.08, p  = 0.40), but a lower risk emerged for fatal and non-fatal MI (27.3 vs 33.5, HR 0.81, 95% CI 0.68, 0.98, p  = 0.030) and any diabetes-related endpoint (69.5 vs 82.1, HR 0.83, 95% CI 0.72, 0.97, p  = 0.016). These differences persisted after extensive multivariable adjustment. Conclusions/interpretation In concert with features such as prompting, feedback, clinical guidelines and continuing medical education, individualisation of goal setting and drug treatment may safely be applied to treat patients newly diagnosed with type 2 diabetes to lower the risk of diabetes complications.

Anemia is an important prognostic factor in hemodialysis patients. It has been reported that parathyroidectomy ameliorates anemia and reduces the requirement of postoperative erythropoiesis-stimulating agents. The objective of this study was to assess the effect of cinacalcet, which is considered as a pharmacological parathyroidectomy, on anemia in hemodialysis patients. We used data from a prospective cohort of Japanese hemodialysis patients with secondary hyperparathyroidism; the criteria were: intact parathyroid hormone concentrations ≥ 180 pg/mL or use of an intravenous or oral vitamin D receptor activator. All patients were cinacalcet-naïve at study enrollment. The main outcome measure was achievement of the target hemoglobin level (≥10.0 g/dL), which was measured repeatedly every 6 months. Cinacalcet exposure was defined as cumulative time since initiation. Both conventional longitudinal models and marginal structural models were adjusted for confounding factors. Among 3,201 cinacalcet-naïve individuals at baseline, cinacalcet was initiated in 1,337 individuals during the follow up. Cinacalcet users were slightly younger; included more patients with chronic glomerulonephritis and fewer with diabetes; were more likely to have a history of parathyroidectomy; and were more often on activated vitamin D agents, phosphate binders, and iron supplements. After adjusting for both time-invariant and time-varying potential confounders, including demographics, comorbidities, comedications, and laboratory values, each additional 6-month duration on cinacalcet was associated with a 1.1-fold increase in the odds of achieving the target hemoglobin level. Cinacalcet may improve anemia in chronic hemodialysis patients with secondary hyperparathyroidism, possibly through pathways both within and outside the parathyroid hormone pathways. Further investigations are warranted to delineate the roles of cinacalcet not only in the management of chronic kidney disease-mineral and bone disorder but also in anemia control.

Background Demonstrating competence in clinical skills is key to course completion for medical students. Methods of providing clinical instruction that foster immediate learning and potentially serve as longer-term repositories for on-demand revision, such as online videos demonstrating competent performance of clinical skills, are increasingly being used. However, their impact on learning has been little studied. The aim of this study was to determine the value of adjunctive on-demand video-based training for clinical skills acquisition by medical students in endocrinology. Methods Following an endocrinology clinical tutorial program, 2 nd year medical students in the pre-assessment revision period were recruited and randomized to either a set of bespoke on-line clinical skills training videos (TV), or to revision as usual (RAU). The skills demonstrated on video were history taking in diabetes mellitus (DMH), examination for diabetes lower limb complications (LLE), and examination for signs of thyroid disease (TE). Students were assessed on these clinical skills in an observed structured clinical examination two weeks after randomization. Assessors were blinded to student randomization status. Results For both diabetes related clinical skills assessment tasks, students in the TV group performed significantly better than those in the RAU group. There were no between group differences in thyroid examination performance. For the LLE, 91.7% (n = 11/12) of students randomized to the video were rated globally as competent at the skill compared with 40% (n = 4/10) of students not randomized to the video (p = 0.024). For the DMH, 83.3% (n = 10/12) of students randomized to the video were rated globally as competent at the skill compared with 20% (n = 2/10) of students not randomized to the video (p = 0.007). Conclusion Exposure to high quality videos demonstrating clinical skills can significantly improve medical student skill performance in an observed structured clinical examination of these skills, when used as an adjunct to clinical skills face-to-face tutorials and deliberate practice of skills in a blended learning format. Video demonstrations can provide an enduring, on-demand, portable resource for revision, which can even be used at the bedside by learners. Such resources are cost-effectively scalable for large numbers of learners.

The association of Helicobacter pylori eradication with the occurrence of renal dysfunction in patients with peptic ulcer diseases is still unclear. This study aimed to clarify the relevance of H. pylori eradication to the occurrence of chronic kidney diseases in patients with peptic ulcer diseases. Data that were available from 2000-2011 were extracted from the National Health Insurance Research Database in Taiwan, and all patients with peptic ulcer diseases (n = 208 196) were screened for eligibility. We divided randomly selected patients into an H. pylori eradication cohort (cohort A, n = 3593) and matched them by age and sex to a without H. pylori eradication cohort (cohort B, n = 3593). Subgroup analysis was further performed for H. pylori eradication within ≤ 90 days of the diagnosis date (early eradication, n = 2837) and within 91-365 days (non-early eradication, n = 756). Cox proportional hazards regression analysis was used to estimate the association of H. pylori eradication with the risk of developing chronic kidney diseases and mortality. We observed that there were more patients suffering from chronic kidney disease in cohort B than in the early eradication subgroup of cohort A (8.49% vs. 6.70%, respectively, p = 0.0075); the mortality rate was also higher in cohort B (4.76% vs. 3.70%, respectively, p = 0.0376). Old age, pulmonary disease, connective tissue disorders, and diabetes were risk factors for chronic kidney diseases but early H. pylori eradication was a protective factor against chronic kidney diseases (hazard ratio: 0.68, 95% confidence interval: 0.52-0.88, p = 0.0030), and death (hazard ratio: 0.69, 95% confidence interval: 0.49-0.96, p = 0.0297). In conclusion, our findings have important implications suggesting that early H. pylori eradication is mandatory since it is associated with a protective role against the occurrence of chronic kidney diseases.