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Background: We hypothesize that the prevalence of unknown heart failure in diabetic patients aged 60 years and over is relatively high (15% or more) and that a cost-effective strategy can be developed to detect heart failure in these patients. The strategy is expected to include some signs and symptoms (such as dyspnoea, orthopnoea, pulmonary crepitations and laterally displaced apical beat), natriuretic peptide measurements (Amino-terminal B-type natriuretic peptide) and possibly electrocardiography. In a subset of patients straightforward echocardiography may show to be cost-effective. With information from our study the detection of previously unknown heart failure in diabetic patients could be improved and enable the physician to initiate beneficial morbidity and mortality reducing heart failure treatment more timely.Primary Objectives: - To assess the prevalence of (previously unrecognised) heart failure in primary care patients with diabetes type 2.- To establish the most cost-effective diagnostic strategy to detect unrecognised heart failure in these patients.Secondary Objectives: - To assess the impact of heart failure, and the combination of a new diagnosis with accordingly treatment in patients with diabetes type 2 on health status.Methods/design: Design: A prospective diagnostic efficiency study.Patient Population: Patients aged 60 years and older with diabetes type 2 from primary care, enlisted with the diabetes service of the Diagnostic Center in Etten-Leur (SHL)All participants will be investigated at the cardiology out-patient department of the regional hospital (Oosterschelde Hospital in Goes, Zeeland, the Netherlands) during a single 1.5 hour standardised diagnostic assessment, including history taking, physical examination, electrocardiography, echocardiography, blood tests, and Health status questionnaires. Patients will be asked if we can contact them afterwards for follow-up and for repeating the questionnaires after three and 12 months.Main study parameters/endpoints: Prevalence (with exact 95% confidence intervals) of (previously unrecognised) heart failure (systolic and 'isolated' diastolic) and the diagnostic value of signs and symptoms, NT-proBNP, electrocardiography and a combination of these items. The cost-effectiveness of different diagnostic strategies. Impact of heart failure and the combination of a new diagnosis with accordingly treatment on health status.Trial Registration: CCMO register NL2271704108. [ABSTRACT FROM AUTHOR]

Background: Chronically ill patients such as people with type 2 diabetes develop perceptions of their illness, which will influence their coping behaviour. Perceptions are formed once a health threat has been recognised. Many people with type 2 diabetes suffer from multimorbidity, for example the combination with cardiovascular disease. Perceptions of one illness may influence perceptions of the other condition. The aim of the current study was to evaluate the effect of an intervention in type 2 diabetes patients with a first acute coronary event on change in illness perceptions and whether this mediates the intervention effect on health status. The current study is a secondary data analysis of a RCT., Methods: Two hundred one participants were randomised (1:1 ratio) to the intervention (n = 101, three home visits) or control group (n = 100). Outcome variables were diabetes and acute coronary event perceptions, assessed with the two separate Brief Illness Perceptions Questionnaires (BIPQs); and health status (Euroqol Visual Analog Scale (EQ-VAS)). The intervention effect was analysed using ANCOVA. Linear regression analyses were used to assess whether illness perceptions mediated the intervention effect on health status., Results: A positive intervention effect was found on the BIPQ diabetes items coherence and treatment control (F = 8.19, p = 0.005; F = 14.01, p < 0.001). No intervention effect was found on the other BIPQ diabetes items consequence, personal control, identity, illness concern and emotional representation. Regarding the acute coronary event, a positive intervention effect on treatment control was found (F = 7.81, p = 0.006). No intervention effect was found on the other items of the acute coronary event BIPQ. Better diabetes coherence was associated with improved health status, whereas perceiving more treatment control was not. The mediating effect of the diabetes perception 'coherence' on health status was not significant., Conclusion: Targeting illness perceptions of people with diabetes after an acute coronary event has no effect on most domains, but can improve the perceived understanding of their diabetes. Discussing perceptions prevents people with type 2 diabetes who recently experienced an acute coronary event from the perception that they will lose control of both their diabetes and the acute coronary event. Illness perceptions of diabetes patients should therefore be discussed in the dynamic period after an acute coronary event., Trial Registration: Nederlands trial register; NTR3076 , Registered September 20 2011.

Background: Type 2 diabetes mellitus (T2DM) patients experience many psychosocial problems related to their diabetes. These often lead to emotional disorders such as distress, stress, anxiety and depression, resulting in decreased self-care, quality of life and disease control. The purpose of the current study is to evaluate the effectiveness of a brief value-based emotion-focused educational programme in adults with T2DM on diabetes-related distress (DRD), depressive symptoms, illness perceptions, quality of life, diabetes self-efficacy, self-care and clinical outcomes., Methods: A cluster randomised controlled trial will be conducted in 10 public health clinics in Malaysia, all providing diabetes care according to national clinical practice guidelines. Patients' inclusion criteria: Malay, ≥ 18 years with T2DM for at least 2 years, on regular follow-up with one of three biomarkers HbA1c, systolic blood pressure and LDL-cholesterol sub-optimally controlled, and with a mean 17-item Diabetes Distress Scale (DDS-17) score ≥ 3. The intervention consists of four sessions and one booster over a period of 4 months that provide information and skills to assist patients in having proper perceptions of their T2DM including an understanding of the treatment targets, understanding and managing their emotions and goal-setting. The comparator is an attention-control group with three meetings over a similar period. With an estimated intra-cluster correlation coefficient ρ of 0.015, a cluster size of 20 and 20% non-completion, the trial will need to enroll 198 patients., Primary Outcome: the between groups difference in proportion of patients achieving a mean DDS-17 score < 3 (non-significant distress) at 6 months post-intervention. Secondary outcomes will be the differences in the above mentioned variables between groups., Discussion: We hypothesize that primary and secondary outcomes will improve significantly after the intervention compared to the comparator group. The results of this study can contribute to better care for T2DM patients with DRD., Trial Registration: ClinicalTrials.gov NCT02730078 . Registered on 29 March 2016, last updated on 4 January 2017.

Background: Many self-management programs have been developed so far. Their effectiveness varies. The program 'Beyond Good Intentions' (BGI) is based on proactive coping and has proven to be (cost-) effective in achieving reductions in BMI and blood pressure in screen-detected type 2 diabetes patients up until nine months follow-up. However, its long-term effectiveness in people already known with diabetes is lacking. In addition, its (cost-) effectiveness might increase if people who are likely not to be benefit from the program are excluded in a valid way. Therefore it was aimed to investigate the long-term effects of the educational program BGI on cardiovascular risk, quality of life and diabetes self-management behaviour in a pre-selected group of patients known with type 2 diabetes up to 5 years., Methods: Randomised controlled trial with 2.5 year follow-up. Adults (≤75 years) with a type 2 diabetes duration between 3 months and 5 years will be included. With the use of a self-management screening tool (SeMaS) their potential barriers of self-management due to depression and/or anxiety will be determined. Based on the results of the SeMaS selection patients will be randomised (1:1) to the BGI-group (n = 53) or the control-group (n = 53). In addition to receiving usual care, patients in the BGI-group will follow the 12-week theory-based self-management program and a booster session a few months thereafter. The control-group will receive care as usual. The primary outcome is change in Body Mass Index after 2.5 years follow-up. Secondary outcomes are HbA1c, lipid profile and systolic blood pressure, (diabetes) quality of life, level of physical activity, dietary intake and medication adherence and proactive coping. Cost-effectiveness will be based on total use of health care resources during the entire study period. Difference between groups in change over time will be analysed according to intention-to-treat analysis., Conclusions: By differentiating between patients who will and those who are likely not to benefit from the educational program, a more (cost-) effective self-management program might be designed, also on the long-run. Trial registration NTR 5330.

Aims: To determine whether US and European participants in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial differ regarding risk factors for cardiovascular mortality and morbidity., Methods: Baseline data, stratified for prior cardiovascular disease (CVD), were compared using multivariable logistic regression analysis to establish whether region is an independent determinant of achieved targets for glycated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL)-cholesterol., Results: Independent of CVD history, US participants were more often of non-White origin and had a longer history of type 2 diabetes, higher body weight, and higher baseline HbA1c. They had substantially lower systolic and diastolic BP, and a marginally lower LDL-cholesterol level. Fewer US participants were diagnosed with left ventricular dysfunction. In the largest group of patients, those with prior CVD and the highest cardiovascular risk, US participants were more often female, had a higher waist circumference, and had a decreased estimated glomerular filtration rate, but less frequently prior myocardial infarction or angina pectoris., Conclusions: There were baseline differences between US and European participants. These differences may result from variation in regional targets for cardiovascular risk factor management, and should be considered in the analysis and reporting of the trial results. Clinical trial identifier: ClinicalTrials.gov, NCT01179048.

Background: The worldwide epidemic of type 2 diabetes (T2DM) underlines the need for diabetes prevention strategies. In this study the feasibility and effectiveness of a nurse led lifestyle program for subjects with impaired fasting glucose (IFG) is assessed., Methods: A cluster randomized clinical trial in 26 primary care practices in the Netherlands included 366 participants older than 45 years with newly diagnosed IFG and motivated to change their lifestyle (intervention group, n = 197; usual care group, n = 169). The one-year intervention, consisting of four to five individual nurse-led consultations, was directed at improving physical activity and dietary habits. The primary outcome measure was body mass index (BMI). Linear and logistic multilevel analyses and a process evaluation were performed., Results: Both groups showed small reductions in BMI at 1 and 2 years, but differences between groups were not significant. At both 1 and 2-year follow-up the number of participants physically active for at least 30 minutes at least five days a week was significantly improved in the intervention group compared to the usual care group (intervention group vs. usual care group: OR1year = 3.53; 95 % CI = 1.69-7.37 and OR2years = 1.97; 95 % CI = 1.22-3.20, respectively). The total drop-out rate was 24 %. Process evaluation revealed that participants in the intervention group received fewer consultations than advised, while some practice nurses and participants considered the RM protocol too intensive., Conclusions: This relatively simple lifestyle program in subjects with IFG resulted in a significant improvement in reported physical activity, but not in BMI. Despite its simplicity, some participants still considered the intervention too intensive. This viewpoint could be related to poor motivation and an absence of disease burden due to IFG, such that participants do not feel a need for behavioural change. Although the intervention provided some benefit, its wider use cannot be advised., Trial Registration: Current Controlled Trials ISRCTN41209683 , date of registration 16/10/2013h  .

Background: Perceptions of illness are important determinants of health behaviour. A better understanding of perceptions of obesity might allow more effective interventions that challenge these perceptions through lifestyle modification programs. Although several studies have evaluated causal attributions with regard to obesity, other domains of illness perception, such as the perceived consequences of obesity and perceived controllability, have not yet been studied. The aim of the current study was to explore perceptions regarding causes, consequences, control, concerns and time course of obesity of centrally obese adults, with and without an elevated cardiometabolic risk and with or without weight loss, 3 years after screening for metabolic syndrome, and to compare these perceptions., Methods: Three groups were selected from a longitudinal study dependent on the baseline and 3-year follow-up profiles: individuals with central obesity and metabolic syndrome at both time points ('persistent cardiometabolic-risk group', n = 80), those with central obesity but without metabolic syndrome on either occasion ('persistent obese group', n = 63), and formerly obese individuals ('improved cardiometabolic-risk group', n = 49). Perceptions of obesity were assessed using an adapted version of the Brief Illness Perception Questionnaire (BIPQ, range 0-10). Chi-square and Kruskal-Wallis tests were performed to compare the 'persistent cardiometabolic risk' group with the other two groups with regard to patient characteristics and BIPQ scores., Results: Both males and females who improved their cardiometabolic risk perceived their obesity as shorter (median (IQR): 3.0 (4.0) vs. 6.0 (3.0), p < 0.001) and experienced greater personal control over their weight (7.0 (3.0) vs. 5.0 (3.0), p = 0.002) compared to those who did not improve. Females who improved their cardiometabolic risk experienced fewer identity and illness concerns, this was not found for males. Other scores did not differ between groups., Conclusion: Obese adults with an improved cardiometabolic risk profile felt greater personal control and considered their obesity to be of shorter duration. Persistence of central obesity with additional cardiometabolic risk factors had a larger impact on female than male participants with respect to identity and illness concerns. Whether discussing 'personal control' is a favourable element in lifestyle intervention should now be assessed in the setting of a controlled trial.

Background: No more than 10-15% of type 2 diabetes mellitus (T2DM) patients achieve all treatment goals regarding glycaemic control, lipids and blood pressure. Shared decision making (SDM) should increase that percentage; however, not all support decision tools are appropriate. Because the ADDITION-Europe study demonstrated two (almost) equally effective treatments but with slightly different intensities, it may be a good starting point to discuss with the patients their diabetes treatment, taking into account both the intensity of treatment, clinical factors and patients' preferences. We aim to evaluate whether such an approach increases the proportion of patients that achieve all three treatment goals., Methods: In a cluster-randomised trial including 40 general practices, that participated until 2009 in the ADDITION Study, 150 T2DM patients 60-80 years, known with T2DM for 8-15 years, will be included. Practices are randomised a second time, i.e. intervention practices in the ADDITION study could be control practices in the current study and vice versa. For the GPs from the intervention group a 2-hour training in SDM was developed as well as a decision support tool to be used during the consultation. GPs plan the first visit with the patients to decide on the intensity of the treatment, personalised targets and the priorities of treatment. The control group will continue with the treatment they were allocated to in the ADDITION study., Follow-Up: 24 months. The primary outcome is the proportion of patients who achieve all three treatment goals. Secondary outcomes are the proportion of patients who achieve five treatment goals (HbA1c, blood pressure, total cholesterol, body weight, not smoking), evaluation of the SDM process (SDM-Q9 and CPS), satisfaction with the treatment (DTSQ), wellbeing and quality of life (W-BQ12, ADD QoL-19), health status (SF-36, EQ-5D) and coping (DCMQ). The proportions of achieved treatment goals will be compared between both groups. For the secondary outcomes mixed models will be used. The Medical Research Ethics Committee of the University Medical Centre Utrecht has approved the study protocol (Protocol number: 11-153)., Discussion: This trial will provide evidence whether an intervention with a multi-faceted decision support tool increases the proportion of achieved personalised goals in type 2 diabetes patients., Trial Registration: NCT02285881, November 4, 2014.

Background: In recent years, most Dutch general practitioners started working under the umbrella of diabetes care groups, responsible for the organisation and coordination of diabetes care. The quality management of these new organisations receives growing interest, although its association with quality of diabetes care is yet unclear. The best way to measure quality management is unknown and it has not yet been studied at the level of outpatient clinics or care groups. We aimed to assess quality management of type 2 diabetes care in care groups and outpatient clinics., Results: Quality management was measured with online questionnaires, containing six domains (see below). They were divided into 28 subdomains, with 59 (care groups) and 57 (outpatient clinics) questions respectively. The mean score of the domains reflects the overall score (0-100%) of an organisation. Two quality managers of all Dutch care groups and outpatient clinics were invited to fill out the questionnaire.Sixty care groups (response rate 61.9%) showed a mean score of 59.6% (CI 57.1-62.1%). The average score in 52 outpatient clinics (response rate 50.0%) was 61.9% (CI 57.5-66.8%).Mean scores on the six domains for care groups and outpatient clinics respectively were: 'organisation of care' 71.9% (CI 68.8-74.9%), 76.8% (CI 72.8-80.7%); 'multidisciplinary teamwork' 67.1% (CI 62.4-71.9%), 71.5% (CI 65.3-77.8%); 'patient centeredness' 46.7% (CI 42.6-50.7%), 62.5% (CI 57.7-67.2%); 'performance management' 63.3% (CI 61.2-65.3%), 50.9% (CI 44.2-57.5%); 'quality improvement policy' 52.6% (CI 49.2-56.1%), 50.9% (CI 44.6-57.3%); and 'management strategies' 56.0% (CI 51.4-60.7%), 59.0% (CI 52.8-65.2%). On subdomains, care groups scored highest on 'care program' (83.3%) and 'measured outcomes' (98.3%) and lowest on 'patient safety' (15.1%) and 'patient involvement' (17.7%). Outpatient clinics scored high on the presence of a 'diabetic foot team' (81.6%) and the support in 'self-management' (81.0%) and low on 'patient involvement' (26.8%) and 'inspection of medical file' (28.0%)., Conclusions: This nationwide assessment reveals that the level of quality management in diabetes care varies between several subdomains in both diabetes care groups and outpatient clinics.

Background: The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus (T2DM) patients (one to three years post-diagnosis) and their partners. The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life. The content of the course is based on the Common-Sense Model of Self-Regulation (CSM). Furthermore, principles from the Social Cognitive Theory (SCT) and social support theories are integrated., Methods/design: We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands. Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties, as measured with a three-item screener. Participating patients and their partners are randomly allocated to the intervention or control condition. Participants in the intervention condition receive three monthly group sessions and a booster session three months later. Participants in the control condition receive a single information meeting. Data will be collected at baseline (T0), directly after the programme (T1) and six months post-programme (T2), including: self-management, diabetes-specific health-related quality of life, illness perceptions, attitudes, social support and empowerment. A three-level multilevel model will be used to compare change-scores between the conditions (intervention/control) on each outcome., Discussion: Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients. The important role of patients' partners in effective diabetes care is also acknowledged in the study., Trial Registration: Netherlands National Trial Register (NTR) NTR3302.

Background: Many type 2 diabetes mellitus patients face difficulties self-managing their illness, which can lead to high levels of diabetes-related distress. Diabetes distress may be decreased by peer support, as peers understand and have dealt with similar problems, and can help motivate each other. A recent systematic review concluded that evidence of benefits of peer support in patients with type 2 diabetes mellitus is too inconsistent due to weak theoretical foundation of the interventions. This study describes the design of a trial evaluating the effectiveness of a group-based, peer support programme with a strong theoretical foundation on diabetes-related distress in type 2 diabetes patients., Methods: This is a parallel group randomised controlled trial of a six session group-based peer support intervention, delivered by peer leaders and group psychotherapists, compared with one educational meeting on diabetes. At least 152 patients with a type 2 diabetes duration of three years or more and between 50 and 70 years of age, recruited via their general practitioner, will be randomised to receive the peer support intervention or one educational meeting. The intervention is developed in line with three key stages of research development of the Medical Research Council framework. The primary outcome measure for this study is diabetes-related distress. Secondary outcomes include self-management behaviour, well-being and health-related quality of life. Perceived social support is a process measure. Outcomes will be measured one month before, and 6, and 12 months after the intervention by means of self-reported questionnaires. Analysis will be on an intention-to-treat basis., Discussion: This article contains a description of the design of a study that will investigate the effect of a group-based, peer support intervention on diabetes-related distress in type 2 diabetes patients. The intervention was developed in recognition of the limited evidence, and the importance of a theoretical foundation and its implementation. Findings will contribute to knowledge in the field of peer support and patient-important outcomes in type 2 diabetes patients., Trial Registration: Dutch Trial Registry: NTR3474.

Background: Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE., Methods: Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity., Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients., Trial Registration: NCT01801631.

Background: Effective diabetes prevention strategies that can be implemented in daily practice, without huge amounts of money and a lot of personnel are needed. The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose (IFG; according to WHO criteria: 6.1 to 6.9 mmol/l) to a sustainable healthy lifestyle change: 'the road map towards diabetes prevention' (abbreviated: Road Map: RM). This protocol is applied within a primary health care setting by a general practitioner and a practice nurse. The feasibility and (cost-) effectiveness of care provided according to the RM protocol will be evaluated., Methods/design: A cluster randomised clinical trial is performed, with randomisation at the level of the general practices. Both opportunistic screening and active case finding took place among clients with high risk factors for diabetes. After IFG is diagnosed, motivated people in the intervention practices receive 3-4 consultations by the practice nurse within one year. During these consultations they are coached to increase the level of physical activity and healthy dietary habits. If necessary, participants are referred to a dietician, physiotherapist, lifestyle programs and/or local sports activities. The control group receives care as usual. The primary outcome measure in this study is change in Body Mass Index (BMI). Secondary outcome measures are waist circumference, physical activity, total and saturated fat intake, systolic blood pressure, blood glucose, total cholesterol, HDL cholesterol, triglycerides and behaviour determinants like risk perception, perceived knowledge and motivation. Based on a sample size calculation 120 people in each group are needed. Measurements are performed at baseline, and after one (post-intervention) and two years follow up. Anthropometrics and biochemical parameters are assessed in the practices and physical activity, food intake and their determinants by a validated questionnaire. The cost-effectiveness is estimated by using the Chronic Disease Model (CDM). Feasibility will be tested by interviews among health care professionals., Discussion: The results of the study will provide valuable information for both health care professionals and policy makers. If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale., Trial Registration: ISRCTN41209683. Ethical approval number: NL31342.075.10.

Background: Patient's satisfaction with monitoring frequency is of interest when implementing six-monthly monitoring for well-controlled type 2 diabetes patients. Here we want to determine the satisfaction of well-controlled type 2 diabetes patients with either three-monthly or six-monthly diabetes monitoring and their future preference., Methods: Survey among 2215 well-controlled type 2 diabetes patients (not using insulin, HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg and total cholesterol ≤5.2 mmol/l) who participated in the EFFIMODI study, a randomised controlled patient-preference equivalence trial. At baseline, participants were asked whether they had a strong preference for three-monthly or six-monthly monitoring or not. If not, they were randomised to either three-monthly or six-monthly monitoring, while the others were monitored according to their preference. After eighteen months, all participants were asked whether they were satisfied with the monitoring frequency and about their future preference. Patient characteristics associated with satisfaction were also examined., Results: Most patients (70.8%) would like to continue their monitoring frequency. Patients from the preference groups were more often satisfied than randomised patients (92.7% and 88.1%, respectively) and patients monitored three-monthly were more often satisfied than patients monitored six-monthly (93.5% and 88.5%, respectively). Higher age, better physical health, less diabetes-related distress, higher diabetes treatment satisfaction and less perceived hyper- and hypoglycaemias were associated with a higher monitoring satisfaction., Conclusions: Most well-controlled type 2 diabetes patients were satisfied with their monitoring frequency and would like to continue it. Although the satisfaction for three-monthly monitoring was slightly higher, the satisfaction with six-monthly monitoring was still rather high (88.5%)., Trial Registration: Current controlled trials ISRCTN93201802.

Background: Worldwide, the organisation of diabetes care is changing. As a result general practices and diabetes teams in hospitals are becoming part of new organisations in which multidisciplinary care programs are implemented. In the Netherlands, 97 diabetes care groups and 104 outpatient clinics are working with a diabetes care program. Both types of organisations aim to improve the quality of diabetes care. Therefore, it is essential to understand the comprehensive elements needed for optimal quality management at organisational level. This study aims to assess the current level of diabetes quality management in both care groups and outpatient clinics and its improvement after providing feedback on their quality management system and tailored support., Methods/design: This study is a before-after study with a one-year follow-up comparing the levels of quality management before and after an intervention to improve diabetes quality management. To assess the status of quality management, online questionnaires were developed based on current literature. They consist of six domains: organisation of care, multidisciplinary teamwork, patient centeredness, performance management, quality improvement policy and management strategies. Based on the questionnaires, respondents will receive feedback on their score in a radar diagram and an elucidating table. They will also be granted access to an online toolbox with instruments that proved to be effective in quality of care improvement and with practical examples. If requested, personal support in implementing these tools will be available. After one year quality management will be measured again using the same questionnaire., Discussion: This study will reveal a nationwide picture of quality management in diabetes care groups and outpatient clinics in the Netherlands and evaluate the effect of offering tailored support. The operationalisation of quality management on organisational level may be of interest for other countries as well.

Background: Type 2 diabetes patients have a decreased health-related quality of life compared to healthy persons, especially regarding physical functioning and well-being. Health-related quality of life is even lower in type 2 diabetes patients when other diseases co-exist. In contrast to earlier studies, we assessed the associations between the number and type of comorbidities and health status in well-controlled type 2 diabetes patients, in whom treatment goals for HbA1c, blood pressure and cholesterol had been reached. Approximately one in five type 2 diabetes patients belongs to this group., Methods: Cross-sectional analysis was performed in 2086 well-controlled (HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg, total cholesterol ≤5.2 mmol/l and not using insulin) type 2 diabetes patients in general practice. Both number and type (cardiovascular and non-cardiovascular) of comorbidities were determined for each patient. Health status was assessed with the questionnaires Short Form-36 (SF-36) and EuroQol (EQ). The SF-36 generates eight dimensions of health and a Physical and Mental Component Score (PCS and MCS), scale: 0-100. The EQ consists of two parts: EQ-5D and EQ Visual Analogue Scale. Multivariable linear regression analysis was used to assess if number and type of comorbidities were associated with health status., Results: Well-controlled type 2 diabetes patients with comorbidities had a much lower health status, with a decrease ranging from -1.5 for the MCS to -26.3 for role limitations due to physical problems, compared to those without. Health status decreased when the number of comorbidities increased, except for mental health, role limitations due to emotional problems, MCS and both EQ measures. In patients with both cardiovascular and non-cardiovascular comorbidity, physical functioning, role limitations due to physical problems and PCS were significantly lower than in patients with only cardiovascular comorbidity. Physical functioning was also lower compared to patients with only non-cardiovascular comorbidity., Conclusions: Even acceptable values of HbA1c, blood pressure and cholesterol in type 2 diabetes patients are not necessarily related with a good health status. We have shown that comorbidities have a large impact on health status. Physicians may take into account patient's health status and integrate the impact of comorbidities into diabetes care.

Background: Early detection and treatment of the metabolic syndrome may prevent diabetes and cardiovascular disease. Our aim was to assess remission of the metabolic syndrome and its determinants after a population based screening without predefined intervention in the Netherlands., Methods: In 2006 we detected 406 metabolic syndrome cases (The National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) definition) among apparently healthy individuals with an increased waist circumference. They received usual care in a primary care setting. After three years metabolic syndrome status was re-measured. We evaluated which baseline determinants were independently associated with remission., Results: The remission rate among the 194 participants was 53%. Baseline determinants independently associated with a remission were the presence of more than three metabolic syndrome components (OR 0.46) and higher levels of waist circumference (OR 0.91), blood pressure (OR 0.98) and fasting glucose (OR 0.60)., Conclusions: In a population with screen-detected metabolic syndrome receiving usual care, more than half of the participants achieved a remission after three years. This positive result after a relatively simple strategy provides a solid basis for a nation-wide implementation. Not so much socio-demographic variables but a higher number and level of the metabolic syndrome components were predictors of a lower chance of remission. In such cases, primary care physicians should be extra alert.

Background: People with central obesity have an increased risk for developing the metabolic syndrome, type 2 diabetes and cardiovascular disease. However, a substantial part of obese individuals have no other cardiovascular risk factors, besides their obesity. High sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation and a predictor of type 2 diabetes and cardiovascular disease, is associated with the metabolic syndrome and its separate components. We evaluated the use of hs-CRP to discriminate between centrally obese people with and without the metabolic syndrome., Methods: 1165 people with central obesity but without any previous diagnosis of hypertension, dyslipidemia, diabetes or cardiovascular disease, aged 20-70 years, underwent a physical examination and laboratory assays to determine the presence of the metabolic syndrome (NCEP ATP III criteria). Multivariable linear regression analyses were performed to assess which metabolic syndrome components were independently associated with hs-CRP. A ROC curve was drawn and the area under the curve was calculated to evaluate whether hs-CRP was capable to predict the presence of the metabolic syndrome., Results: Median hs-CRP levels were significantly higher in individuals with central obesity with the metabolic syndrome (n = 417; 35.8%) compared to individuals with central obesity without the metabolic syndrome (2.2 mg/L (IQR 1.2-4.0) versus 1.7 mg/L (IQR 1.0-3.4); p < 0.001). Median hs-CRP levels increased with an increasing number of metabolic syndrome components present. In multivariable linear regression analyses, waist circumference and triglycerides were the only components that were independently associated with hs-CRP after adjusting for smoking, gender, alcohol consumption and the other metabolic syndrome components. The area under the ROC curve was 0.57 (95%-CI 0.53-0.60)., Conclusions: Hs-CRP has limited capacity to predict the presence of the metabolic syndrome in a population with central obesity.

Background: Scientific evidence for the frequency of monitoring of type 2 diabetes patients is lacking. If three-monthly control in general practice could be reduced to six-monthly control in some patients, this would on the one hand reduce the use of medical services including involvement of practice nurses, and thus reduce costs, and on the other hand alleviate the burden of people with type 2 diabetes. The goal of this study is to make primary diabetes care as efficient as possible for patients and health care providers. Therefore, we want to determine whether six-monthly monitoring of well-controlled type 2 diabetes patients in primary care leads to equivalent cardiometabolic control compared to the generally recommended three-monthly monitoring., Methods and Design: The study is a randomised controlled patient-preference equivalence trial. Participants are asked if they prefer three-monthly (usual care) or six-monthly diabetes monitoring. If they do not have a preference, they are randomised to a three-monthly or six-monthly monitoring group. Patients are eligible for the study if they are between 40 and 80 years old, diagnosed with type 2 diabetes more than one year ago, treated by a general practitioner, not on insulin treatment, and with HbA1c < or = 7.5%, systolic blood pressure < or = 145 mmHg and total cholesterol < or = 5.2 mmol/l. The intervention group (six-monthly monitoring) will receive the same treatment with the same treatment targets as the control group (three-monthly monitoring). The intervention period will last one and a half year. After the intervention, the three-monthly and six-monthly monitoring groups are compared on equivalence of cardiometabolic control. Secondary outcome measures are HbA1c, blood pressure, cholesterol level, Body Mass Index, smoking behaviour, physical activity, loss of work due to illness, health status, diabetes-specific distress, satisfaction with treatment and adherence to medications. We will use intention-to-treat analysis with repeated measures. For outcomes that have only baseline and final measurements, we will use ANCOVA. Depending on the results, a cost-minimisation analysis or an incremental cost-effectiveness analysis will be done., Discussion: This study will provide valuable information on the most efficient control frequency of well-controlled type 2 diabetes patients in primary care.

Background: People with non-diabetic hyperglycaemia might be at risk of lacking adequate control for cardiovascular risk factors. Our aim was to determine the extent of health care utilization and provision in primary care and to evaluate the risk of cardiovascular disease in persons with an elevated risk score in a stepwise diabetes screening programme., Methods: A total of 56,978 non-diabetic patients, aged 50-70 years, from 79 practices in the Netherlands were invited to participate in a screening programme starting with a questionnaire. Those with an elevated score, underwent further glucose testing. Screened participants with type 2 diabetes (n = 64), impaired glucose tolerance (IGT) (n = 62), impaired fasting glucose (IFG) (n = 86), and normal glucose tolerance (NGT) (n = 142) were compared after three years regarding use of medication, care provider encounters and occurrence of CVD., Results: In all glucose regulation categories cardiovascular medication was prescribed more frequently during follow-up with the strongest increase in diabetic patients. Number of practice visits was higher in diabetic patients compared to those in the other categories. Glucose, lipids, and blood pressure were measured most frequently in diabetic patients. Numbers of cardiovascular events in participants with NGT, IFG, IGT and diabetes were 16.7, 32.6, 17.3 and 15.7 per 1,000 person-years (non significant), respectively., Conclusion: After three years of follow-up, screened non-diabetic participants with an elevated risk score had cardiovascular event rates comparable with diabetic patients. Screened non-diabetic persons are at risk of lacking optimal control for cardiovascular risk factors while screen-detected diabetic patients were controlled adequately.