Cardiovascular risk management among individuals with type 2 diabetes and severe mental illness: a cohort study.

AIMS/HYPOTHESIS: The aim of this study was to compare cardiovascular risk management among people with type 2 diabetes according to severe mental illness (SMI) status. METHODS: We used linked electronic data to perform a retrospective cohort study of adults diagnosed with type 2 diabetes in Scotland between 2004 and 2020, ascertaining their history of SMI from hospital admission records. We compared total cholesterol, systolic BP and HbA1c target level achievement 1 year after diabetes diagnosis, and receipt of a statin prescription at diagnosis and 1 year thereafter, by SMI status using logistic regression, adjusting for sociodemographic factors and clinical history. RESULTS: We included 291,644 individuals with type 2 diabetes, of whom 1.0% had schizophrenia, 0.5% had bipolar disorder and 3.3% had major depression. People with SMI were less likely to achieve cholesterol targets, although this difference did not reach statistical significance for all disorders. However, people with SMI were more likely to achieve systolic BP targets compared to those without SMI, with effect estimates being largest for schizophrenia (men: adjusted OR 1.72; 95% CI 1.49, 1.98; women: OR 1.64; 95% CI 1.38, 1.96). HbA1c target achievement differed by SMI disorder and sex. Among people without previous CVD, statin prescribing was similar or better in those with vs those without SMI at diabetes diagnosis and 1 year later. In people with prior CVD, SMI was associated with lower odds of statin prescribing at diabetes diagnosis (schizophrenia: OR 0.54; 95% CI 0.43, 0.68, bipolar disorder: OR 0.75; 95% CI 0.56, 1.01, major depression: OR 0.92; 95% CI 0.83, 1.01), with this difference generally persisting 1 year later. CONCLUSIONS/INTERPRETATION: We found disparities in cholesterol target achievement and statin prescribing by SMI status. This reinforces the importance of clinical review of statin prescribing for secondary prevention of CVD, particularly among people with SMI.

Sex differences in body composition in people with prediabetes and type 2 diabetes as compared with people with normal glucose metabolism: the Maastricht Study.

AIMS/HYPOTHESIS: Obesity is a major risk factor for type 2 diabetes. However, body composition differs between women and men. In this study we investigate the association between diabetes status and body composition and whether this association is moderated by sex. METHODS: In a population-based cohort study (n=7639; age 40-75 years, 50% women, 25% type 2 diabetes), we estimated the sex-specific associations, and differences therein, of prediabetes (i.e. impaired fasting glucose and/or impaired glucose tolerance) and type 2 diabetes (reference: normal glucose metabolism [NGM]) with dual-energy x-ray absorptiometry (DEXA)- and MRI-derived measures of body composition and with hip circumference. Sex differences were analysed using adjusted regression models with interaction terms of sex-by-diabetes status. RESULTS: Compared with their NGM counterparts, both women and men with prediabetes and type 2 diabetes had more fat and lean mass and a greater hip circumference. The differences in subcutaneous adipose tissue, hip circumference and total and peripheral lean mass between type 2 diabetes and NGM were greater in women than men (women minus men [W-M] mean difference [95% CI]: 15.0 cm2 [1.5, 28.5], 3.2 cm [2.2, 4.1], 690 g [8, 1372] and 443 g [142, 744], respectively). The difference in visceral adipose tissue between type 2 diabetes and NGM was greater in men than women (W-M mean difference [95% CI]: -14.8 cm2 [-26.4, -3.1]). There was no sex difference in the percentage of liver fat between type 2 diabetes and NGM. The differences in measures of body composition between prediabetes and NGM were generally in the same direction, but were not significantly different between women and men. CONCLUSIONS/INTERPRETATION: This study indicates that there are sex differences in body composition associated with type 2 diabetes. The pathophysiological significance of these sex-associated differences requires further study.

Sex comparisons in the association of prediabetes and type 2 diabetes with cognitive function, depression, and quality of life: The Maastricht study.

AIMS: There are sex differences in the excess risk of diabetes-associated cardiovascular disease. However, it is not clear whether these sex differences exist with regard to other complications like mental health aspects. Therefore, we investigated sex differences in the association of prediabetes and type 2 diabetes (T2D) with cognitive function, depression, and quality of life (QoL). MATERIALS AND METHODS: In a population-based cross-sectional cohort study (n = 7639; age 40-75 years, 50% women, 25% T2D), we estimated sex-specific associations, and differences therein, of prediabetes and T2D (reference: normal glucose metabolism) with measures of cognitive function, depression, and physical and mental QoL. Sex differences were analysed using multiple regression models with interaction terms. RESULTS: In general, T2D, but not prediabetes, was associated with higher odds of cognitive impairment, major depressive disorder, and poorer QoL. The odds ratio (OR) of cognitive impairment associated with T2D was 1.29 (95% CI: 0.96-1.72) for women and 1.39 (1.10-1.75) for men. The OR of major depressive disorder associated with T2D was 1.19 (0.69-2.04) for women and 1.68 (1.02-2.75) for men. The mean difference of the physical QoL score (ranging from 0 to 100, with 100 indicating the best possible QoL) associated with T2D was -2.09 (-2.92 to -1.25) for women and -1.81 (-2.48 to -1.13) for men. The mean difference of the mental QoL score associated with T2D was -0.90 (-1.79 to -0.02) for women and -0.52 (-1.23 to 0.20) for men. There was no clear pattern of sex differences in the associations of either prediabetes or T2D with measures of cognitive function, depression, or QoL. CONCLUSIONS: In general, T2D was associated with worse cognitive function, depression, and poorer QoL. The strength of these associations was similar among women and men.

High on-treatment platelet reactivity in peripheral arterial disease: A systematic review.

OBJECTIVES: To highlight current evidence pertaining to the measurement methods and prevalence of high on-treatment platelet reactivity (HTPR) in patients with PAD, as well as to evaluate the relationship between HTPR and recurrent adverse cardiovascular and limb events in PAD patients. METHODS: A systematic review of English-language literature on HTPR in patients with PAD. An electronic literature search of PubMed and Medline was performed in May 2021. RESULTS: A total of 29 studies with a total number of 11,201 patients with PAD were identified. HTPR during clopidogrel treatment ranges from 9.8 to 77%, and during aspirin treatment ranges from 4.1 to 50% of PAD patients. HTPR was associated with adverse clinical outcomes. The need for limb revascularisation was higher in patients with HTPR during clopidogrel use. Similarly, HTPR during aspirin use in the PAD population was predictive of adverse cardiovascular events (HR 3.73; 95% CI, 1.43-9.81; p = .007). A wide range of techniques were applied to measure platelet resistance, without consensus on cut-off values. Furthermore, differing patient populations, a variety of antiplatelet regimens, and differing clinical endpoints highlight the high degree of heterogeneity in the studies included in this review. CONCLUSION: No consensus on technique or cut-off values for HTPR testing has been reached. Patients with HTPR are potentially at a greater risk of adverse limb-related and cardiovascular events than patients sensitive to antiplatelet therapy illustrating the need for clinical implementation of HTPR testing. Future research must aim for consistent methodology. Adaptation of antiplatelet therapy based on HTPR results requires further exploration.

Achieving diabetes treatment targets in people with registered mental illness is similar or improved compared with those without: Analyses of linked observational datasets.

AIMS: To determine the association between registered mental illness and type 2 diabetes mellitus treatment targets, while taking into account the effects of health expenditure and social determinants of health. METHODS: This observational cross-sectional study was based on routine primary care data, linked to socio-economic and medical claims data. The main outcomes, analysed by multivariate logistic regression, were achieving primary care guideline treatment targets for HbA1c , systolic blood pressure (SBP) and LDL-cholesterol in 2017. We examined the association with diagnosed mental illness registered by the general practitioner (GP) or treated via specialist' mental healthcare between 2016 and 2018, adjusting for, medication use, body mass index, co-morbidity, smoking, and additionally examining effect-modification of healthcare expenditures, migration status, income and demographics. RESULTS: Overall (N = 2862), 64.0% of participants achieved their treatment targets for HbA1c , 65.1% for SBP and 53.0% for LDL-cholesterol. Adjusted for migrant background, income and care expenditures, individuals <65 years of age with mental illness achieved their HbA1c treatment target more often than those without (OR (95% CI)): treatment by GP: 1.46 (1.01, 2.11), specialist care: 1.61 (1.11, 2.34), as did men with mental illness for SBP: GP OR 1.61 (1.09, 2.40), specialist care OR 1.59 (1.09, 2.45). LDL-cholesterol target was not associated with mental illness. A migrant background or low income lowered the likelihood of reaching HbA1c targets. CONCLUSIONS: People with registered mental illness appear comparable or better able to achieve diabetes treatment targets than those without. Achieving HbA1c targets is influenced by social disadvantage.

Sex differences in the association of prediabetes and type 2 diabetes with microvascular complications and function: The Maastricht Study.

BACKGROUND: Women with type 2 diabetes are disproportionally affected by macrovascular complications; we here investigated whether this is also the case for microvascular complications and retinal microvascular measures. METHODS: In a population-based cohort study of individuals aged 40-75 years (n = 3410; 49% women, 29% type 2 diabetes (oversampled by design)), we estimated sex-specific associations, and differences therein, of (pre)diabetes (reference: normal glucose metabolism), and of continuous measures of glycemia with microvascular complications and retinal measures (nephropathy, sensory neuropathy, and retinal arteriolar and venular diameters and dilatation). Sex differences were analyzed using regression models with interaction terms (i.e. sex-by- (pre)diabetes and sex-by-glycemia) and were adjusted for potential confounders. RESULTS: Men with type 2 diabetes (but not those with prediabetes) compared to men with normal glucose metabolism, (and men with higher levels of glycemia), had significantly higher prevalences of nephropathy (odds ratio: 1.58 95% CI (1.01;2.46)) and sensory neuropathy (odds ratio: 2.46 (1.67;3.63)), larger retinal arteriolar diameters (difference: 4.29 µm (1.22;7.36)) and less retinal arteriolar dilatation (difference: - 0.74% (- 1.22; - 0.25)). In women, these associations were numerically in the same direction, but generally not statistically significant (odds ratios: 1.71 (0.90;3.25) and 1.22 (0.75;1.98); differences: 0.29 µm (- 3.50;4.07) and: - 0.52% (- 1.11;0.08), respectively). Interaction analyses revealed no consistent pattern of sex differences in the associations of either prediabetes or type 2 diabetes or glycemia with microvascular complications or retinal measures. The prevalence of advanced-stage complications was too low for evaluation. CONCLUSIONS: Our findings show that women with type 2 diabetes are not disproportionately affected by early microvascular complications.

Association of weight loss and weight loss maintenance following diabetes diagnosis by screening and incidence of cardiovascular disease and all-cause mortality: An observational analysis of the ADDITION-Europe trial.

AIMS: Short-term weight loss may lead to remission of type 2 diabetes but the effect of maintained weight loss on cardiovascular disease (CVD) is unknown. We quantified the associations between changes in weight 5 years following a diagnosis of diabetes, and incident CVD events and mortality up to 10 years after diagnosis. MATERIALS AND METHODS: Observational analysis of the ADDITION-Europe trial of 2730 adults with screen-detected type 2 diabetes from the UK, Denmark and the Netherlands. We defined weight change based on the maintenance at 5 years of weight loss achieved during the year after diabetes diagnosis, and as 5-year overall change in weight. Incident CVD events (n = 229) and all-cause mortality (n = 225) from 5 to 10 years follow-up were ascertained from medical records. RESULTS: Gaining >2% weight during the year after diabetes diagnosis was associated with higher hazard of all-cause mortality versus maintaining weight [hazard ratio (95% confidence interval): 3.18 (1.30-7.82)]. Losing ≥5% weight 1 year after diagnosis was also associated with mortality, whether or not weight loss was maintained at 5 years: 2.47 (0.99-6.21) and 2.72 (1.17-6.30), respectively. Losing ≥10% weight over 5 years was associated with mortality among those with body mass index <30 kg/m2 [4.62 (1.87-11.42)]. Associations with CVD incidence were inconclusive. CONCLUSIONS: Both weight loss and weight gain after screen-detected diabetes diagnosis were associated with higher mortality, but not CVD events, particularly among participants without obesity. The clinical implications of weight loss following a diagnosis of diabetes probably depend on its magnitude and timing, and may differ by body mass index status. Personalization of weight loss advice and support may be warranted.

Type 2 diabetes and COPD: treatment in the right healthcare setting? An observational study.

BACKGROUND: Type 2 diabetes (T2DM) and COPD are chronic medical conditions, for which patients need lifelong healthcare. The aim of this study is to examine in which healthcare setting patients with T2DM and COPD receive their care, and if this is the correct healthcare setting according to guidelines. METHOD: T2DM and COPD patients from five primary care practices were included. Data concerning healthcare setting and patient- and clinical characteristics were extracted from the electronic medical records. Patient profiles treated in primary care were compared with the profiles of those treated in secondary care. In patients treated in secondary care we evaluated whether treatment allocation was according to the guidelines and if back-referral to primary care should take place. RESULTS: Of the T2DM and COPD patients 7.6% and 29.6% respectively, were treated in secondary care, and 72.7% respectively 31.4% of these were according to the guideline. T2DM patients treated in primary care were older (63 versus 57 years, p < 0.01, had a shorter diabetes duration (8 versus 11 years, p < 0.01) and lower HbA1c (53.0 versus 63.5 mmol/l, p < 0.01) than those treated in secondary care. Those with COPD treated in primary care used less inhalation medication (75.2 versus 90.1%, p < 0.01) and had better spirometry results (67.39 versus 57.53 FEV1%pred, p < 0.01). CONCLUSION: The majority of the patients with T2DM and COPD were correctly treated in primary care and on average patients with a better health condition were treated in primary care.. Also, those who were treated in secondary care were most of the time treated in the correct treatment setting according to the guidelines.

Discussing overweight in children during a regular consultation in general practice: a qualitative study.

BACKGROUND: Overweight in children is a rising problem leading to serious consequences later in life. The Dutch guideline 'Obesity' for general practitioners recommends discussing obesity in children regardless of the reason of consultation and provides diagnostic and therapeutic tools. However, limited literature indicates that general practitioners experience barriers to discuss this topic. The aim of this study was to determine current perceived barriers of general practitioners in discussing overweight during a regular consultation in children aged 4 to 12 years and to what extent they discuss the topic. Furthermore, we attempt to get more insight in the specific needs and ideas for improvement among GPs. METHODS: A semi-structured in-depth interview study was conducted. Dutch general practitioners with a broad range of demographic characteristics were invited to participate. The transcripts were analysed using a modified version of the constant comparative method. Using this method, we identified perceived barriers of general practitioners. RESULTS: Ten general practitioners were included in the study. Four major themes were identified in the interviews: absence of physical or mental complaints related to overweight, internal barriers of the general practitioners, the child's family background and logistics. Major barriers appeared to be a low consultation rate of these children, the sensitivity of the topic (e.g. fear for children's or parents' reactions and/or disturbance of the relation, influence on the self-esteem of the child, resistance in the parents), the absence of a long-standing relation between general practitioner and child or parent, the background of the child and lack of time or prioritizing. CONCLUSION: Dutch general practitioners indicate to experience barriers and need tools for how to discuss children's overweight during regular consultations within the limited time available. The low consultation rate among children aged 4 to 12 years due to lack of physical complaints is mentioned as a new and important barrier. Therefore, the prior focus might be raising awareness among parents concerning overweight in children aged 4 to 12 years and, thereby, stressing the potential supporting role of primary care professionals in tackling the overweight of their child.

European Society of Cardiology: Cardiovascular Disease Statistics 2017.

Aims: The European Society of Cardiology (ESC) Atlas has been compiled by the European Heart Agency to document cardiovascular disease (CVD) statistics of the 56 ESC member countries. A major aim of this 2017 data presentation has been to compare high-income and middle-income ESC member countries to identify inequalities in disease burden, outcomes, and service provision. Methods and results: The Atlas utilizes a variety of data sources, including the World Health Organization, the Institute for Health Metrics and Evaluation, and the World Bank to document risk factors, prevalence, and mortality of cardiovascular disease and national economic indicators. It also includes novel ESC-sponsored survey data of health infrastructure and cardiovascular service provision provided by the national societies of the ESC member countries. Data presentation is descriptive with no attempt to attach statistical significance to differences observed in stratified analyses. Important differences were identified between the high-income and middle-income member countries of the ESC with regard to CVD risk factors, disease incidence, and mortality. For both women and men, the age-standardized prevalence of hypertension was lower in high-income countries (18% and 27%) compared with middle-income countries (24% and 30%). Smoking prevalence in men (not women) was also lower (26% vs. 41%) and together these inequalities are likely to have contributed to the higher CVD mortality in middle-income countries. Declines in CVD mortality have seen cancer becoming a more common cause of death in a number of high-income member countries, but in middle-income countries declines in CVD mortality have been less consistent where CVD remains the leading cause of death. Inequalities in CVD mortality are emphasized by the smaller contribution they make to potential years of life lost in high-income countries compared with middle-income countries both for women (13% vs. 23%) and men (20% vs. 27%). The downward mortality trends for CVD may, however, be threatened by the emerging obesity epidemic that is seeing rates of diabetes increasing across all the ESC member countries. Survey data from the National Cardiac Societies showed that rates of cardiac catheterization and coronary artery bypass surgery, as well as the number of specialist centres required to deliver them, were greatest in the high-income member countries of the ESC. The Atlas confirmed that these ESC member countries, where the facilities for the contemporary treatment of coronary disease were best developed, were often those in which declines in coronary mortality have been most pronounced. Economic resources were not the only driver for delivery of equitable cardiovascular health care, as some middle-income ESC member countries reported rates for interventional procedures and device implantations that matched or exceeded the rates in wealthier member countries. Conclusion: In documenting national CVD statistics, the Atlas provides valuable insights into the inequalities in risk factors, health care delivery, and outcomes of CVD across the ESC member countries. The availability of these data will underpin the ESC's ambitious mission 'to reduce the burden of cardiovascular disease' not only in its member countries but also in nation states around the world.

Overtreatment of older patients with type 2 diabetes mellitus in primary care.

Given that there are indications of overtreatment in older patients with type 2 diabetes in both the United States and Europe, we assessed the level of personalized diabetes treatment for older patients in primary care, focusing on overtreatment. Based on Dutch guidelines individuals aged ≥70 years were classified into 3 glycated haemoglobin (HbA1c) treatment target groups: 7% (53 mmol/mol), 7.5% (58 mmol/mol) and 8% (64 mmol/mol). In our cohort of 1002 patients (n = 319 aged ≥70 years), the 165 patients with HbA1c targets >7% had more micro- and macrovascular complications, more often used ≥5 medicines and were more often frail compared with those with an HbA1c target ≤7%. Of these 165 patients, 64 (38.8%) were overtreated; that is, 20% of all people aged ≥70 years. The majority of overtreated people were frail and used ≥5 medicines. Hypoglycaemia occurred in 20.3% of these patients and almost 30% reported accidents involving falls. Personalized treatment in older people with type 2 diabetes is not common practice. A substantial number of older people are overtreated, with probable harmful consequences. To prevent overtreatment, definition of lower HbA1c limits might be helpful.

Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - design of a randomised controlled trial ('TRIGGER study').

BACKGROUND: Health care providers aim to stimulate self-management in type 2 diabetes (T2DM) patients. However, they have a limited number of patient contacts to do this. With the growing number of T2DM patients, innovative and cost-effective interventions to promote self-management are needed. We aim to evaluate the effectiveness of diabetes self-management education via a smartphone app in T2DM patients on insulin therapy. METHODS: Non-blinded two-arm multi-centre randomised controlled superiority trial with parallel-groups and equal randomisation ('TRIGGER study'). Eligible patients are 40-70 years, on insulin therapy since at least 3 months, with HbA1c > 53 mmol/mol (> 7%). In total 228 patients will be recruited. The intervention group (n = 114) will receive diabetes self-management education via a smartphone app to trigger diabetes self-management: unidirectional text messages, free of charge, evidence and psychological theory based, with regard to dietary habits, physical activity, hypoglycaemia and glucose variability. Patients choose their preferred frequency (two to six times per week), topics (two or three additionally to hypoglycaemia, which is an obligatory topic), and duration (6 or 9 months). The control group (n = 114) will receive care-as-usual. The primary study endpoint is the HbA1c level after a follow-up of 6 months. The percentage of patients who achieve an HbA1c level ≤ 53 mmol/mol (≤7%) without hypoglycaemia (plasma glucose < 3.5 mmol/L (< 63 mg/dL)) is a co-primary outcome. Secondary outcomes are body mass index, waist circumference, insulin dose, lipid profile, blood pressure, number of hypoglycaemic events, glycaemic variability, self-management (SDSCA), food habits (FFQ), physical activity (IPAQ), health status (EQ-5D-5 L, SF36), diabetes-dependent quality of life (ADDQoL), diabetes treatment satisfaction (DTSQ), satisfaction with the app, the cost-effectiveness of the intervention after 3 months, and sustainability of the intervention effect (3 months extra follow-up in intervention group to compare prolonged to discontinued use of the app). We will use the intention-to-treat principle to analyse data. DISCUSSION: Innovative solutions are needed to improve the (cost-) effectiveness of self-management for the increasing number of T2DM patients. This trial will provide evidence on the effectiveness of a newly developed smartphone app, designed to trigger diabetes self-management. TRIAL REGISTRATION: Dutch Trial Register NTR5515 , registration date: 18 November 2015 (prospectively registered).

Disentangling the effect of illness perceptions on health status in people with type 2 diabetes after an acute coronary event.

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.

Diabetes care providers' opinions and working methods after four years of experience with a diabetes patient web portal; a survey among health care providers in general practices and an outpatient clinic.

BACKGROUND: To gain insight into the opinions and working methods of diabetes care providers after using a diabetes web portal for 4 years in order to understand the role of the provider in patients' web portal use. METHODS: Survey among physicians and nurses from general practices and an outpatient clinic, correlated with data from the common web portal. RESULTS: One hundred twenty-eight questionnaires were analysed (response rate 56.6%). Responders' mean age was 46.2 ± 9.8 years and 43.8% were physicians. The majority was of opinion that the portal improves patients' diabetes knowledge (90.6%) and quality of care (72.7%). Although uploading glucose diary (93.6%) and patient access to laboratory and clinical notes (91.2 and 71.0%) were considered important, these features were recommended to patients in only 71.8 and 19.5% respectively. 64.8% declared they informed their patients about the portal and 45.3% handed-out the information leaflet and website address. The portal was especially recommended to type 1 diabetes patients (78.3%); those on insulin (84.3%) and patients aged< 65 years (72.4%). Few found it timesaving (21.9%). Diabetes care providers' opinions were not associated with patients' portal use. CONCLUSIONS: Providers are positive about patients web portals but still not recommend or encourage the use to all patients. There seems room for improvement in their working methods.

Validity and reliability of a Malay version of the brief illness perception questionnaire for patients with type 2 diabetes mellitus.

BACKGROUND: Illness perceptions involve the personal beliefs that patients have about their illness and may influence health behaviours considerably. Since an instrument to measure these perceptions for Malay population in Malaysia is lacking, we translated and examined the psychometric properties of the Malay version of the Brief Illness Perception Questionnaire (MBIPQ) in adult patients with type 2 diabetes mellitus. METHODS: The MBIPQ has nine items, all use a 0-10 response scale, except the ninth item about causal factors, which is an open-ended item. A standard procedure was used to translate and adapt the English BIPQ into Malay language. Construct validity was examined comparing item scores and scores on the Diabetes Management Self-Efficacy Scale, the Morisky Medication Adherence Scale, the World Health Organization Quality of Life-brief, the 9-item Patient Health Questionnaire, the 17-item Diabetes Distress Scale, HbA1c and the presence of complications. In addition, 2-week and 4-week test-retest reliability were studied. RESULTS: A total of 312 patients completed the MBIPQ. Out of this, 97 and 215 patients completed the 2- or 4-weeks test-retest reliability questionnaire, respectively. Moderate inter-items correlations were observed between illness perception dimensions (r = -0.31 to 0.53). MBIPQ items showed the expected correlations with self-efficacy (r = 0.35), medication adherence (r = 0.29), quality of life (r = -0.17 to 0.31) and depressive symptoms (r = -0.18 to 0.21). People with severe diabetes-related distress also were more concern (t-test = 4.01, p < 0.001) and experienced lower personal control (t-test = 2.07, p = 0.031). People with any diabetes-related complication perceived the consequences as more serious (t-test = 2.04, p = 0.044). The 2-week and 4-week test-retest reliabilities varied between ICCagreement 0.39 to 0.70 and 0.58 to 0.78, respectively. CONCLUSIONS: The psychometric properties of items in the MBIPQ are moderate. The MBIPQ showed good cross-cultural validity and moderate construct validity. Test-retest reliability was moderate. Despite the moderate psychometric properties, the MBIPQ may be useful in clinical practice as it is a useful instrument to elicit and communicate on patient's personal thoughts and feelings. Future research is needed to establish its responsiveness and predictive validity. TRIAL REGISTRATION: ClinicalTrials.gov NCT02730754 registered on March 29, 2016; NCT02730078 registered on March 29, 2016.

The effectiveness of a value-based EMOtion-cognition-Focused educatIonal programme to reduce diabetes-related distress in Malay adults with Type 2 diabetes (VEMOFIT): study protocol for a cluster randomised controlled trial.

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.

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

BACKGROUND: Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms. OBJECTIVES: To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects. DATA COLLECTION AND ANALYSIS: Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates. MAIN RESULTS: We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA. AUTHORS' CONCLUSIONS: Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.

Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients: A cluster-randomized trial (OPTIMAL).

OBJECTIVE: About 20% of patients with type 2 diabetes achieve all their treatment targets. Shared decision making (SDM) using a support aid based on the 5-years results of the ADDITION study on multifactorial treatment, could increase this proportion. RESEARCH DESIGN AND METHODS: Cluster-randomized trial in 35 former ADDITION primary care practices. Practices were randomized to SDM or care as usual (1:1). Both ADDITION and non-ADDITION type 2 diabetes patients, 60-80 years, known with diabetes for 8-12 years, were included. In the intervention group, patients were presented evidence about the relationship between treatment intensity and cardiovascular events. They chose intensive or less intensive treatment and prioritized their targets. After 1 year priorities could be rearranged. FOLLOW-UP: 24 months. Intention-to-treat analysis. MAIN OUTCOME MEASURE: proportion of patients that achieved all three treatment targets. RESULTS: At baseline 26.4% in the SDM group (n=72) had already achieved all three treatment goals (CG: 23.5%, n=81). In the SDM group 44 patients chose intensive treatment, 25 continued their former less intensive treatment and three people switched from the more to the less intensive protocol. After 24 months 31.8% of the patients in the SDM group achieved all three treatment targets (CG: 25.3%), RR 1.26 (95% CI 0.81-1.95). Mean systolic blood pressure decreased in the SDM group (-5.4 mm Hg, P<.01), mean HbA1c and total cholesterol did not change. CONCLUSIONS: Despite an already high baseline level of diabetes care, we found strong indications that SDM on both intensity of treatment and prioritizing treatment goals further improved outcomes.

Oral Hypoglycemic Agents Added to Insulin Monotherapy for Type 2 Diabetes.

CLINICAL QUESTION: Among patients with type 2 diabetes mellitus who do not achieve optimal glycemic control with insulin monotherapy, is the addition of oral hypoglycemic agents associated with benefits (measured by lowering of hemoglobin A1c) or adverse effects? BOTTOM LINE: Adding a sulfonylurea to insulin was associated with more hypoglycemic events compared with insulin alone, but this association was not observed for metformin. Adding a sulfonylurea or metformin to insulin was associated with a decrease in hemoglobin A1c of approximately 1.0%.

Efficacy of three therapy approaches in preschool children with cerebral palsy: a randomized controlled trial.

AIM: To examine the efficacy of child-focused, context-focused, and regular care approaches, delivered in a rehabilitation setting by physical or occupational therapists to preschool children with cerebral palsy (CP), in optimizing the child's self-care and mobility capabilities. METHOD: A multicentre randomized controlled trial clustered at therapist level was conducted in 13 rehabilitation centres. It included 68 children with CP (38 males, 30 females; mean age 3y, SD 6mo, range 1y 11mo-4y), classified as Gross Motor Function Classification System levels I to IV, who were already receiving therapy. Children received a child-focused, context-focused, or regular care approach during a 6-month period. Self-care and mobility capabilities were assessed with the Functional Skills Scale of the Pediatric Evaluation of Disability Inventory. RESULTS: The child-focused, context-focused, and regular care approaches all resulted in significant but similar improvements in self-care (regular: reference; child-focused: ß=-0.11, 95% confidence interval [CI] -0.68 to 0.46; context-focused: ß=0.13, CI -0.38 to 0.64) and mobility (regular: reference; child-focused: ß=-0.09, CI=-0.93 to 0.75; and context-focused: ß=0.14, CI -0.65 to 0.94) capabilities. INTERPRETATION: The results suggest that the three therapy approaches were equally efficacious for preschool children with CP. Depending on a child's individual situation each approach can be selected.