Socio-economic status and HbA1c in type 2 diabetes: A systematic review and meta-analysis.

Up until now, differences in HbA1c levels by socio-economic status (SES) have been identified, but not yet quantified in people with type 2 diabetes. The aim of this study was therefore to assess the difference in HbA1c levels between people with type 2 diabetes of different SES in a systematic review and meta-analysis. A systematic literature search was conducted in MEDLINE, Embase, Ebsco, and the Cochrane Library until January 14, 2018. Included studies described adults with type 2 diabetes in whom the association between SES and HbA1c levels was studied. Studies were rated for methodological quality and data were synthesized quantitatively (meta-analysis) and qualitatively (levels of evidence), stratified for type of SES variable, i.e., education, income, deprivation, and employment. Fifty-one studies were included: 15 high, 27 moderate, and 9 of low methodological quality. Strong evidence was provided that people of low SES have higher HbA1c levels than people of high SES, for deprivation, education, and employment status. The pooled mean difference in HbA1c levels between people of low and high SES was 0.26% (95% CI, 0.09-0.43) or 3.12 mmol/mol (95% CI, 1.21-5.04) for education and 0.20% (95% CI, -0.05 to 0.46) or 2.36 mmol/mol (95%CI, -0.61 to 5.33) for income. In conclusion, our systematic review and meta-analysis showed that there was an inverse association between SES and HbA1c levels in people with type 2 diabetes. Future research should focus on finding SES-sensitive strategies to reduce HbA1c levels in people with type 2 diabetes.

Health care providers' perceived barriers to and need for the implementation of a national integrated health care standard on childhood obesity in the Netherlands - a mixed methods approach.

BACKGROUND: In 2010, a national integrated health care standard for (childhood) obesity was published and disseminated in the Netherlands. The aim of this study is to gain insight into the needs of health care providers and the barriers they face in terms of implementing this integrated health care standard. METHODS: A mixed-methods approach was applied using focus groups, semi-structured, face-to-face interviews and an e-mail-based internet survey. The study's participants included: general practitioners (GPs) (focus groups); health care providers in different professions (face-to-face interviews) and health care providers, including GPs; youth health care workers; pediatricians; dieticians; psychologists and physiotherapists (survey). First, the transcripts from the focus groups were analyzed thematically. The themes identified in this process were then used to analyze the interviews. The results of the analysis of the qualitative data were used to construct the statements used in the e-mail-based internet survey. Responses to items were measured on a 5-point Likert scale and were categorized into three outcomes: 'agree' or 'important' (response categories 1 and 2), 'disagree' or 'not important'. RESULTS: Twenty-seven of the GPs that were invited (51 %) participated in four focus groups. Seven of the nine health care professionals that were invited (78 %) participated in the interviews and 222 questionnaires (17 %) were returned and included in the analysis. The following key barriers were identified with regard to the implementation of the integrated health care standard: reluctance to raise the subject; perceived lack of motivation and knowledge on the part of the parents; previous negative experiences with lifestyle programs; financial constraints and the lack of a structured multidisciplinary approach. The main needs identified were: increased knowledge and awareness on the part of both health care providers and parents/children; a social map of effective intervention; structural funding; task rearrangements; a central care coordinator and structural information feedback from the health care providers involved. CONCLUSIONS: The integrated health care standard stipulate that the care of overweight or obese children be provided using an integrated approach. The barriers and needs identified in this study can be used to define strategies to improve the implementation of the integrated health care standard pertaining to overweight and obese children in the Netherlands.

Consumer willingness to invest money and time for benefits of lifestyle behaviour change: an application of the contingent valuation method.

OBJECTIVE: To use contingent valuation (CV) to derive individual consumer values for both health and broader benefits of a public-health intervention directed at lifestyle behaviour change (LBC) and to examine the feasibility and validity of the method. METHOD: Participants of a lifestyle intervention trial (n = 515) were invited to complete an online CV survey. Respondents (n = 312) expressed willingness to invest money and time for changes in life expectancy, health-related quality of life (HRQOL) and broader quality of life aspects. Internal validity was tested for by exploring associations between explanatory variables (i.e. income, paid work, experience and risk factors for cardiovascular diseases) and willingness to invest, and by examining ordering effects and respondents' sensitivity to the scope of the benefits. RESULTS: The majority of respondents (94.3%) attached value to benefits of LBC, and 87.4% were willing to invest both money and time. Respondents were willing to invest more for improvements in HRQOL (€42/month; 3 h/week) and broader quality of life aspects (€40/month; 2.6 h/week) than for improvements in life expectancy (€24/month; 2 h/week). Protest answers were limited (3%) and findings regarding internal validity were mixed. CONCLUSION: The importance of broader quality of life outcomes to consumers suggests that these outcomes are relevant to be considered in the decision making. Our research showed that CV is a feasible method to value both health and broader outcomes of LBC, but generalizability to other areas of public health still needs to be examined. Mixed evidence regarding internal validity pleads for caution to use CV as only the base for decision making.

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

BACKGROUND: The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. METHODS: In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. RESULTS: Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). CONCLUSIONS: Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. TRIAL REGISTRATION: Current Controlled trials: ISRCTN66124817.

Risk of a recurrent cardiovascular event in individuals with type 2 diabetes or intermediate hyperglycemia: the Hoorn Study.

OBJECTIVE: To investigate risk of a recurrent cardiovascular event and its predictors in a population-based cohort. RESEARCH DESIGN AND METHODS: Participants of the Hoorn Study who had experienced a first cardiovascular event after baseline (n = 336) were followed with respect to a recurrent event. Absolute risk of a recurrent event was calculated for individuals with normal glucose metabolism, intermediate hyperglycemia, and type 2 diabetes. Cox regression models were used to investigate which variables, measured before the first vascular event, predicted a recurrent event using the stepwise backward procedure. RESULTS: During a median follow-up of 4.1 years, 44% (n = 148) of the population developed a recurrent vascular event. The rate of recurrent events per 100 person-years was 7.2 (95% CI 5.8-8.7) in individuals with normal glucose metabolism, compared with 9.8 (6.6-14.0) in individuals with intermediate hyperglycemia and 12.5 (8.5-17.6) in individuals with type 2 diabetes. Higher age (hazard ratio 1.02 [95% CI 1.00-1.04]), male sex (1.56 [1.08-2.25]), waist circumference (1.02 [1.02-1.03]), higher systolic blood pressure (1.01 [1.01-1.02]), higher HbA1c (%, 1.13 [0.97-1.31]/ mmol/mol, 1.01 [1.00-1.03]), and family history of myocardial infarction (1.38 [0.96-2.00]) predicted a recurrent cardiovascular event. CONCLUSIONS: Individuals with type 2 diabetes, but not individuals with intermediate hyperglycemia, are at increased risk for a recurrent vascular event compared with individuals with normal glucose metabolism. In people with a history of cardiovascular disease, people at increased risk of a recurrent event can be identified based on the patient's risk profile before the first event.

The effects of a lifestyle intervention on leisure-time sedentary behaviors in adults at risk: the Hoorn Prevention Study, a randomized controlled trial.

OBJECTIVE: This study set out to assess the short- and long-term effects of a primary care-based lifestyle intervention on different domains of leisure-time sedentary behaviors in Dutch adults at risk of type 2 diabetes and cardiovascular diseases. METHODS: Between 2007 and 2009, adults (n=622) at risk were randomly assigned to a counseling intervention aimed at adopting healthy lifestyle behaviors, or a control group that only received health brochures. Follow-up measures were done after 6, 12 and 24months. Linear regression analysis was used to examine between-group differences in self-report minutes per day sedentary behaviors, adjusted for baseline values. Stratified analyses were performed for sex and educational attainment. RESULTS: Seventy-nine percent (n=490) of participants completed the last follow-up. Mean baseline sedentary behaviors were 254.6min per day (SD=136.2). Intention-to-treat analyses showed no significant differences in overall or domain-specific sedentary behaviors between the two groups at follow-up. Stratified analyses for educational attainment revealed a small and temporary between-group difference in favor of the intervention group, in those who finished secondary school. CONCLUSIONS: A primary care-based general lifestyle intervention was not more effective in reducing leisure-time sedentary behaviors than providing brochures in adults at risk for chronic diseases.

Economic evaluation of a lifestyle intervention in primary care to prevent type 2 diabetes mellitus and cardiovascular diseases: a randomized controlled trial.

BACKGROUND: Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases, addressing 'real-world' implementation, are needed. This study examines the cost-effectiveness of a primary care intervention from a societal perspective, compared with provision of health brochures, alongside a randomized controlled trial. METHODS: Adults aged 30-50 years, at risk of type 2 diabetes (T2DM) and/or cardiovascular disease (CVD), were recruited from twelve general practices in The Netherlands. They were randomized to the intervention (n = 314) or control group (n = 308). The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse, followed by three-monthly sessions by phone. Costs were collected using three-monthly retrospective questionnaires. Quality of life was measured with the EuroQol-5D-3L, at baseline, 6, 12 and 24 months. Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae, respectively, based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points. RESULTS: Small, statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years (QALYs) gained. The mean difference in costs between the intervention and control group was €-866 (95% confidence interval -2372; 370). The probability that the intervention was cost-effective varied from 93% at €8000/QALY to 88% at €80,000/QALY. CONCLUSION: A primary care lifestyle intervention aimed at adults at increased risk of T2DM and/or CVD could result in cost savings over a two-year period. However, due to methodological uncertainty no advice can be given regarding the implementation of the intervention in Dutch general practices. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59358434.

Consumer preferences for health and nonhealth outcomes of health promotion: results from a discrete choice experiment.

OBJECTIVE: Health promotion (HP) interventions have outcomes that go beyond health. Such broader nonhealth outcomes are usually neglected in economic evaluation studies. To allow for their consideration, insights are needed into the types of nonhealth outcomes that HP interventions produce and their relative importance compared with health outcomes. This study explored consumer preferences for health and nonhealth outcomes of HP in the context of lifestyle behavior change. METHODS: A discrete choice experiment was conducted among participants in a lifestyle intervention (n = 132) and controls (n = 141). Respondents made 16 binary choices between situations that can be experienced after lifestyle behavior change. The situations were described by 10 attributes: future health state value, start point of future health state, life expectancy, clothing size above ideal, days with sufficient relaxation, endurance, experienced control over lifestyle choices, lifestyle improvement of partner and/or children, monetary cost per month, and time cost per week. RESULTS: With the exception of "time cost per week" and "start point of future health state," all attributes significantly determined consumer choices. Thus, both health and nonhealth outcomes affected consumer choice. Marginal rates of substitution between the price attribute and the other attributes revealed that the attributes "endurance," "days with sufficient relaxation," and "future health state value" had the greatest impact on consumer choices. The "life expectancy" attribute had a relatively low impact and for increases of less than 3 years, respondents were not willing to trade. CONCLUSIONS: Health outcomes and nonhealth outcomes of lifestyle behavior change were both important to consumers in this study. Decision makers should respond to consumer preferences and consider nonhealth outcomes when deciding about HP interventions.

Effects of a cognitive behavioural treatment in patients with type 2 diabetes when added to managed care; a randomised controlled trial.

Effects of a cognitive behavioural treatment (CBT) in type 2 diabetes patients were studied in a randomised controlled trial. Patients were recruited from a diabetes care system (DCS). The intervention group (n = 76) received managed care from the DCS and CBT. The control group (n = 78) received managed care only. Effects on risk of developing coronary heart disease (CHD), clinical characteristics, lifestyle, determinants of behaviour change, quality of life, and depression were assessed after 6 and 12 months. The intervention did not result in a significant reduction of CHD risk (difference between intervention and control group was -0.32 % (95 % CI: -2.27; 1.63). The amount of heavy physical activity increased significantly in the intervention group at 6 months [intervention versus control group was 20.14 min/day (95 % CI: 4.6; 35.70)]. Quality of life and level of depression improved as well. All effects disappeared after 6 months. No effects were found on clinical characteristics.

Effects of cardiovascular disease risk communication for patients with type 2 diabetes on risk perception in a randomized controlled trial: the @RISK study.

OBJECTIVE: Patients with type 2 diabetes mellitus (T2DM) underestimate their risk of developing severe complications, and they do not always understand the risk communication by their caregivers. The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease (CVD) in patients with T2DM. RESEARCH DESIGN AND METHODS: A randomized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System (DCS) West-Friesland, a managed-care system in the Netherlands. The intervention group (n = 131) received a six-step CVD risk communication. Control subjects (n = 130) received standard managed care. The primary outcome measure was appropriateness of risk perception (difference between actual CVD risk calculated by the UK Prospective Diabetes Study risk engine and risk perception). Secondary outcome measures were illness perceptions, attitude and intention to change behavior, satisfaction with the communication, and anxiety and worry about CVD risk. Patients completed questionnaires at baseline, at 2 weeks (immediately after the intervention), and at 12 weeks. RESULTS: Appropriateness of risk perception improved between the intervention and control groups at 2 weeks. This effect disappeared at 12 weeks. No effects were found on illness perceptions, attitude and intention to change behavior, or anxiety and worry about CVD risk. Patients in the intervention group were significantly more satisfied with the communication. CONCLUSIONS: This risk communication method improved patients' risk perception at 2 weeks but not at 12 weeks. Negative effects were not found, as patients did not become anxious or worried after the CVD risk communication.

Exploring non-health outcomes of health promotion: the perspective of participants in a lifestyle behaviour change intervention.

OBJECTIVE: To provide insights into health promotion outcomes that are not captured by conventional measures of health outcome used in economic evaluation studies, such as EQ5D based QALYs. METHODS: Twelve semi-structured interviews and five focus group discussions were conducted with participants of a randomized controlled trial (n=52) evaluating the effectiveness of a theory-based lifestyle intervention in Dutch adults at risk for diabetes mellitus and/or cardiovascular disease. Transcripts were analysed by two independent researchers using a thematic analysis approach. RESULTS: In total we identified twelve non-health outcome themes that were important from the participant perspective. Four of these were reported as direct outcomes of the lifestyle intervention and eight were reported as consequences of lifestyle behaviour change. Our findings also suggest that lifestyle behaviour change may have spillover effects to other people in the participants' direct environment. CONCLUSION: This study provides evidence that in the context of lifestyle behaviour change EQ5D based QALYs capture health promotion outcomes only partially. More insights are needed into non-health outcomes and spillover effects produced by health promotion in other contexts and how participants and society value these. Methods to account for these outcomes within an economic evaluation framework need to be developed and tested.

Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin.

BACKGROUND: Self-monitoring of blood glucose (SMBG) has been found to be effective for patients with type 1 diabetes and for patients with type 2 diabetes using insulin. There is much debate on the effectiveness of SMBG as a tool in the self-management for patients with type 2 diabetes who are not using insulin. OBJECTIVES: To assess the effects of SMBG in patients with type 2 diabetes mellitus who are not using insulin. SEARCH METHODS: Multiple electronic bibliographic and ongoing trial databases were searched supplemented with handsearches of references of retrieved articles (date of last search: 07 July 2011). SELECTION CRITERIA: Randomised controlled trials investigating the effects of SMBG compared with usual care, self-monitoring of urine glucose (SMUG) or both in patients with type 2 diabetes who where not using insulin. Studies that used glycosylated haemoglobin A(1c) (HbA(1c)) as primary outcome were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from included studies and evaluated the studies' risk of bias. Data from the studies were compared to decide whether they were sufficiently homogeneous to pool in a meta-analysis. Primary outcomes were HbA(1c), health-related quality of life, well-being and patient satisfaction. Secondary outcomes were fasting plasma glucose level, hypoglycaemic episodes, morbidity, adverse effects and costs. MAIN RESULTS: Twelve randomised controlled trials were included and evaluated outcomes in 3259 randomised patients. Intervention duration ranged from 6 months (26 weeks) to 12 months (52 weeks). Nine trials compared SMBG with usual care without monitoring, one study compared SMBG with SMUG, one study was a three-armed trial comparing SMBG and SMUG with usual care and one study was a three-armed trial comparing less intensive SMBG and more intensive SMBG with a control group. Seven out of 11 studies had a low risk of bias for most indicators. Meta-analysis of studies including patients with a diabetes duration of one year or more showed a statistically significant SMBG induced decrease in HbA(1c) at up to six months follow-up (-0.3; 95% confidence interval (CI) -0.4 to -0.1; 2324 participants, nine trials), yet an overall statistically non-significant SMBG induced decrease was seen at 12 month follow-up (-0.1; 95% CI -0.3 to 0.04; 493 participants, two trials). Qualitative analysis of the effect of SMBG on well-being and quality of life showed no effect on patient satisfaction, general well-being or general health-related quality of life. Two trials reported costs of self-monitoring: One trial compared the costs of self-monitoring of blood glucose with self-monitoring of urine glucose based on nine measurements per week and with the prices in US dollars for self-monitoring in 1990. Authors concluded that total costs in the first year of self-monitoring of blood glucose, with the purchase of a reflectance meter were 12 times more expensive than self-monitoring of urine glucose ($481 or 361 EURO [11/2011 conversion] versus $40 or 30 EURO [11/2011 conversion]). Another trial reported a full economical evaluation of the costs and effects of self-monitoring. At the end of the trial, costs for the intervention were £89 (104 EURO [11/2011 conversion]) for standardized usual care (control group), £181 (212 EURO [11/2011 conversion]) for the less intensive self-monitoring group and £173 (203 EURO [11/2011 conversion]) for the more intensive self-monitoring group. Higher losses to follow-up in the more intensive self-monitoring group were responsible for the difference in costs, compared to the less intensive self-monitoring group.There were few data on the effects on other outcomes and these effects were not statistically significant. None of the studies reported data on morbidity. AUTHORS' CONCLUSIONS: From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycaemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life. More research is needed to explore the psychological impact of SMBG and its impact on diabetes specific quality of life and well-being, as well as the impact of SMBG on hypoglycaemia and diabetic complications.

Measuring pathways towards a healthier lifestyle in the Hoorn Prevention Study: the Determinants of Lifestyle Behavior Questionnaire (DLBQ).

OBJECTIVE: We developed the Determinants of Lifestyle Behavior Questionnaire (DLBQ) to measure determinants of lifestyle behavioral change according to the Theory of Planned Behavior (TPB) in adults at high risk of diabetes type 2 (T2DM) and cardiovascular diseases (CVD). The aim of the current study was to test the validity of the DLBQ. METHODS: From February to September 2008, a cross-sectional survey was conducted in the region West-Friesland (The Netherlands) among 622 adults, aged 30-50 years at high risk of T2DM or CVD participating in a lifestyle intervention trial. Structural equation modeling techniques were used for confirmatory factor analysis and to test correlations between the TPB constructs. RESULTS: The results demonstrate the factorial validity of the DLBQ in this population. The theoretical factor structure of the DLBQ is supported, and 41-56% of the variance in intentions to improve lifestyle behaviors is explained. CONCLUSIONS: The DLBQ proves to be a valid instrument for measuring important determinants of the intention to change three lifestyle behaviors in adults at high risk of T2DM and CVD. PRACTICE IMPLICATIONS: The identified 'key-determinants' of the TPB that seem to contribute to an increased intention to change behavior could be of value in designing future lifestyle interventions.

The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) have an increased risk to develop severe diabetes related complications, especially cardiovascular disease (CVD). The risk to develop CVD can be estimated by means of risk formulas. However, patients have difficulties to understand the outcomes of these formulas. As a result, they may not recognize the importance of changing lifestyle and taking medication in time. Therefore, it is important to develop risk communication methods, that will improve the patients' understanding of risks associated with having diabetes, which enables them to make informed choices about their diabetes care.The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception, attitude and intention to change lifestyle behaviour in patients with T2DM. The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory. METHODS: A randomised controlled trial will be performed in the Diabetes Care System West-Friesland (DCS), a managed care system. Newly referred T2DM patients of the DCS, younger than 75 years will be eligible for the study. The intervention group will be exposed to risk communication on CVD, on top of standard managed care of the DCS. This intervention consists of a simple explanation on the causes and consequences of CVD, and possibilities for prevention. The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram. The control group will receive standard managed care. The primary outcome is appropriateness of risk perception. Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception. Differences between baseline and follow-up (2 and 12 weeks) between groups will be analysed according to the intention-to-treat principle. The study was powered on 120 patients in each group. DISCUSSION: This innovative risk communication method based on two behavioural theories might improve patient's appropriateness of risk perception and attitude concerning lifestyle change. With a better understanding of their CVD risk, patients will be able to make informed choices concerning diabetes care. TRIAL REGISTRATION: The trial is registered as NTR1556 in the Dutch Trial Register.

Effects of self-monitoring of glucose in non-insulin treated patients with type 2 diabetes: design of the IN CONTROL-trial.

BACKGROUND: Diabetes specific emotional problems interfere with the demanding daily management of living with type 2 diabetes mellitus (T2DM). Possibly, offering direct feedback on diabetes management may diminish the presence of diabetes specific emotional problems and might enhance the patients' belief they are able to manage their illness. It is hypothesized that self-monitoring of glucose in combination with an algorithm how and when to act will motivate T2DM patients to become more active participants in their own care leading to a decrease in diabetes related distress and an increased self-efficacy. METHODS AND DESIGN: Six hundred patients with T2DM (45 < or = 75 years) who receive care in a structured diabetes care system, HbA1c > or = 7.0%, and not using insulin will be recruited and randomized into 3 groups; Self-monitoring of Blood Glucose (SMBG), Self-monitoring of Urine Glucose (SMUG) and usual care (n = 200 per group). Participants are eligible if they have a known disease duration of over 1 year and have used SMBG or SMUG less than 3 times in the previous year. All 3 groups will receive standardized diabetes care. The intervention groups will receive additional instructions on how to perform self-monitoring of glucose and how to interpret the results. Main outcome measures are changes in diabetes specific emotional distress and self-efficacy. Secondary outcome measures include difference in HbA1c, patient satisfaction, occurrence of hypoglycaemia, physical activity, costs of direct and indirect healthcare and changes in illness beliefs. DISCUSSION: The IN CONTROL-trial is designed to explore whether feedback from self-monitoring of glucose in T2DM patients who do not require insulin can affect diabetes specific emotional distress and increase self-efficacy. Based on the self-regulation model it is hypothesized that glucose self-monitoring feedback changes illness perceptions, guiding the patient to reduce emotional responses to experienced threats, and influences the patients ability to perform and maintain self-management skills.

Primary prevention of diabetes mellitus type 2 and cardiovascular diseases using a cognitive behavior program aimed at lifestyle changes in people at risk: Design of a randomized controlled trial.

BACKGROUND: The number of people with cardiovascular disease (CVD) and diabetes mellitus type 2 (T2DM) is growing rapidly. To a large extend, this increase is due to lifestyle-dependent risk factors, such as overweight, reduced physical activity, and an unhealthy diet. Changing these risk factors has the potential to postpone or prevent the development of T2DM and CVD. It is hypothesized that a cognitive behavioral program (CBP), focused in particular on motivation and self-management in persons who are at high risk for CVD and/or T2DM, will improve their lifestyle behavior and, as a result, will reduce their risk of developing T2DM and CVD. METHODS: 12,000 inhabitants, 30-50 years of age living in several municipalities in the semi-rural region of West-Friesland will receive an invitation from their general practitioner (n = 13) to measure their own waist circumference with a tape measure. People with abdominal obesity (male waist >/= 102 cm, female waist >or= 88 cm) will be invited to participate in the second step of the screening which includes blood pressure, a blood sample and anthropometric measurements. T2DM and CVD risk scores will then be calculated according to the ARIC and the SCORE formulae, respectively. People with a score that indicates a high risk of developing T2DM and/or CVD will then be randomly assigned to the intervention group (n = 300) or the control group (n = 300).Participants in the intervention group will follow a CBP aimed at modifying their dietary behavior, physical activity, and smoking behavior. The counseling methods that will be used are motivational interviewing (MI) and problem solving treatment (PST), which focus in particular on intrinsic motivation for change and self-management of problems of the participants. The CBP will be provided by trained nurse practitioners in the participant's general practice, and will consists of a maximum of six individual sessions of 30 minutes, followed by 3-monthly booster sessions by phone. Participants in the control group will receive brochures containing health guidelines regarding physical activity and diet, and how to stop smoking. The primary outcome measures will be changes in T2DM and CVD risk scores. Secondary outcome measures will be changes in lifestyle behavior and cost-effectiveness and cost-utility ratios. All relevant direct and indirect costs will be measured, and there will be a follow-up of 24 months. DISCUSSION: Changing behaviors is difficult, requires time, considerable effort and motivation. Combining the two counseling methods MI and PST, followed by booster sessions may result in sustained behavioral change. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59358434.

Work-related physical and psychosocial risk factors for sick leave in patients with neck or upper extremity complaints.

OBJECTIVES: To study work-related physical and psychosocial risk factors for sick leave among patients who have visited their general practitioner for neck or upper extremity complaints. METHODS: Three hundred and forty two patients with neck or upper extremity complaints completed self-report questionnaires at baseline and after 3 months. Cox regression models were used to investigate the association between work-related risk factors and sick leave (i.e., lost days from work due to neck or upper extremity complaints in 3 months). Effect modification by sick leave at baseline, sex, worrying and musculoskeletal co-morbidity was evaluated by adding product terms to the regression models. RESULTS: In the subgroup of patients who scored high on the pain copying scale "worrying" the hazard ratio of sick leave was 1.32 (95% CI 1.07-1.62) per 10% increase in heavy physical work. The subgroup of patients who were sitting for long periods of time had a reduced risk of sick leave as compared to patients who did not spend a lot of time sitting, again only in patients who scored high on the pain coping scale "worrying" (adjusted HR=0.17, 95%-CI 0.04-0.72). Other work-related risk factors were not significantly related to sick leave. CONCLUSIONS: Heavy physical work increased the risk of sick leave and prolonged sitting reduced the risk of sick leave in a subgroup of patients who worried much about their pain. Additional large longitudinal studies of sufficiently large size among employees with neck or upper extremity complaints are needed to confirm our results.

Quality criteria were proposed for measurement properties of health status questionnaires.

OBJECTIVES: Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. STUDY DESIGN AND SETTING: Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. RESULTS: For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. CONCLUSION: Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.

Generalizability of a prediction rule for sick leave due to shoulder pain.

OBJECTIVES: Recently, a rule was developed to predict sick leave related to shoulder pain during a period of 6 months after patients have consulted a general practitioner for a new episode of shoulder pain. The objective was to evaluate the generalizability of this prediction rule by testing it in two other populations of workers who had gone for a consultation in primary care for a new episode of shoulder pain. METHODS: The prediction rule was derived in a prognostic cohort study (N=350). The outcome was sick leave related to shoulder pain during 6 months following the first consultation. The rule was tested on merged control groups from three trials on shoulder pain (N=128). In addition to this population, a recently conducted study on musculoskeletal disorders (N=224) was used to validate the prediction rule. The generalizability of the prediction rule was tested by studying calibration and discrimination in the validation cohorts. RESULTS: The prediction rule showed reasonable calibration in both validation cohorts. The discriminative ability, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.70 in the derivation cohort was stable in the cohort of the musculoskeletal disorder study (AUC 0.71). In the control groups of the three randomized controlled trials of a Dutch shoulder study, the discriminative ability decreased to an AUC of 0.66. CONCLUSIONS: The prediction rule for sick leave related to shoulder pain in a 6-month period following the first consultation in primary care showed adequate generalizability to another population of workers with shoulder pain participating in an observational cohort study. In the control groups of the three randomized controlled trials the prediction rule performed less well.