Development and validation of a Context-sensitive Positive Health Questionnaire (CPHQ): A factor analysis and multivariate regression study.

BACKGROUND: The concept of Positive Health (PH) has gained increasing attention as a way of measuring individuals' ability to adapt in the face of contextual challenges. However, a suitable measurement instrument for PH that encompasses contextual factors has not yet been developed. This paper responds to this need by developing a Context-specific Positive Health (CPH) measurement instrument that aligns with the Capability Approach (CA). METHODS: The measurement instrument was developed and tested among a representative sample of 1002 Dutch internet survey panel members with diverse sociodemographic backgrounds. The instrument was developed in two stages: a preparation phase consisting of focus groups and expert consultations, and a validation among a representative panel of Dutch citizens. The goal of the preparation phase, was to pilot test and refine previously proposed Positive Health questionnaires into an initial version of the CPHQ. The validation phase aimed to examine the initial CPHQ's factorial validity using Factor Analysis, and its concurrent validity using Multivariate Regression Analysis. RESULTS: The developed questionnaire demonstrated adequate factorial and concurrent validity. Furthermore, it explicitly includes an assessment of resilience, this being a key component of PH. CONCLUSIONS: The introduced measurement tool, the CPHQ, comprises 11 dimensions that we have labeled as follows: relaxation, autonomy, fitness, perceived environmental safety, exclusion, social support, financial resources, political representation, health literacy, resilience, and enjoyment. In this article, we present four major contributions. Firstly, we embedded the measurement in a theoretical framework. Secondly, we focused the questionnaire on a key concept of Positive Health - the "ability to adapt." Thirdly, we addressed issues of health inequality by considering contextual factors. Finally, we facilitated the development of more understandable measurement items.

The Effect and Cost-Effectiveness of Offering a Combined Lifestyle Intervention for the Prevention of Cardiovascular Disease in Primary Care: Results of the Healthy Heart Stepped-Wedge Trial.

OBJECTIVE: To evaluate the effectiveness and cost-effectiveness of offering the combined lifestyle programme "Healthy Heart", addressing overweight, diet, physical activity, smoking and alcohol, to improve lifestyle behaviour and reduce cardiovascular risk. DESIGN: A practice-based non-randomised stepped-wedge cluster trial with two-year follow-up. Outcomes were obtained via questionnaires and routine care data. A cost-utility analysis was performed. During the intervention period, "Healthy Heart" was offered during regular cardiovascular risk management consultations in primary care in The Hague, The Netherlands. The period prior to the intervention period served as the control period. RESULTS: In total, 511 participants (control) and 276 (intervention) with a high cardiovascular risk were included (overall mean ± SD age 65.0 ± 9.6; women: 56%). During the intervention period, 40 persons (15%) participated in the Healthy Heart programme. Adjusted outcomes did not differ between the control and intervention period after 3-6 months and 12-24 months. Intervention versus control (95% CI) 3-6 months: weight: ß -0.5 (-1.08-0.05); SBP ß 0.15 (-2.70-2.99); LDL-cholesterol ß 0.07 (-0.22-0.35); HDL-cholesterol ß -0.03 (-0.10-0.05); physical activity ß 38 (-97-171); diet ß 0.95 (-0.93-2.83); alcohol OR 0.81 (0.44-1.49); quit smoking OR 2.54 (0.45-14.24). Results were similar for 12-24 months. Mean QALYs and mean costs of cardiovascular care were comparable over the full study period (mean difference (95% CI) QALYs: -0.10 (-0.20; 0.002); costs: EUR 106 (-80; 293)). CONCLUSIONS: For both the shorter (3-6 months) and longer term (12-24 months), offering the Healthy Heart programme to high-cardiovascular-risk patients did not improve their lifestyle behaviour nor cardiovascular risk and was not cost-effective on a population level.

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.

Sex Disparities in Cardiovascular Risk Factor Assessment and Screening for Diabetes-Related Complications in Individuals With Diabetes: A Systematic Review.

Background: Insight in sex disparities in the detection of cardiovascular risk factors and diabetes-related complications may improve diabetes care. The aim of this systematic review is to study whether sex disparities exist in the assessment of cardiovascular risk factors and screening for diabetes-related complications. Methods: PubMed was systematically searched up to April 2020, followed by manual reference screening and citations checks (snowballing) using Google Scholar. Observational studies were included if they reported on the assessment of cardiovascular risk factors (HbA1c, lipids, blood pressure, smoking status, or BMI) and/or screening for nephropathy, retinopathy, or performance of feet examinations, in men and women with diabetes separately. Studies adjusting their analyses for at least age, or when age was considered as a covariable but left out from the final analyses for various reasons (i.e. backward selection), were included for qualitative analyses. No meta-analyses were planned because substantial heterogeneity between studies was expected. A modified Newcastle-Ottawa Quality Assessment Scale for cohort studies was used to assess risk of bias. Results: Overall, 81 studies were included. The majority of the included studies were from Europe or North America (84%).The number of individuals per study ranged from 200 to 3,135,019 and data were extracted from various data sources in a variety of settings. Screening rates varied considerably across studies. For example, screening rates for retinopathy ranged from 13% to 90%, with half the studies reporting screening rates less than 50%. Mixed findings were found regarding the presence, magnitude, and direction of sex disparities with regard to the assessment of cardiovascular risk factors and screening for diabetes-related complications, with some evidence suggesting that women, compared with men, may be more likely to receive retinopathy screening and less likely to receive foot exams. Conclusion: Overall, no consistent pattern favoring men or women was found with regard to the assessment of cardiovascular risk factors and screening for diabetes-related complications, and screening rates can be improved for both sexes.

Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.

BACKGROUND: The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes. METHODS: As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549. FINDINGS: 343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA1c, blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07). INTERPRETATION: Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant. FUNDING: National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.

A simple to implement and low-cost supervised walking programme in highly motivated individuals with or at risk for type 2 diabetes: An observational study with a pre-post design.

This observational study with a pre-post design, conducted in two Dutch primary healthcare centres, aimed to evaluate the effect of a supervised walking programme in highly motivated individuals with or at risk for type 2 diabetes mellitus (T2DM). Those able and willing to walk at least 6 km, were invited for a 28-week walking programme (February to August 2017), in which participants walked in groups, once weekly under supervision of volunteer healthcare professionals. Changes in bodyweight, BMI, waist circumference, HbA1c, blood pressure, well-being, health status and patient activation were analysed using paired t-tests and the Wilcoxon signed-rank test. Fifty-six people were included (30 T2DM; 26 at risk), of whom 60.7% were female. Mean age was 60.6 years, median BMI 30.8 kg/m2 and mean systolic blood pressure 146.9 mm Hg. Participants with T2DM had median HbA1c of 50.0 mmol/mol. Post-challenge, BMI had decreased to 29.7 kg/m2, and waist circumference decreased 3.4 cm (95% CI 2.1-4.8), both p < 0.01. Systolic and diastolic blood pressure decreased significantly (mean difference 6.5 mm Hg (95% CI 1.6-11.3, p = 0.01) and 3.5 mm Hg (95% CI 1.0-6.0, p < 0.01), respectively). Participants with HbA1c >53 mmol/mol at baseline (n = 8), had median decrease in HbA1c of 6.5 mmol/mol (p = 0.03). Well-being, but not health status and patient activation, improved significantly. In conclusion, in highly motivated individuals with or at risk for T2DM, this simple to implement and low-cost, but intensive, volunteer-based supervised walking programme is favourable, and therefore, can be seen as an option for clinical programs to implement to support highly motivated patients.

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.

What follow-up care and self-management support do patients with type 2 diabetes want after their first acute coronary event? A qualitative study.

AIMS: Despite diabetes patients' efforts to control their disease, many of them are confronted with an acute coronary event. This may evoke depressive feelings and self-management may be complicated. According to the American Diabetes Association, the transition from hospital to home after an acute coronary event (ACE) is a high-risk time for diabetes patients; it should be improved. Before developing an intervention for diabetes patients with an ACE in the period after discharge from hospital, we want to gain a detailed understanding of patients' views, perceptions and feelings in this respect. METHODS: Qualitative design. Two semi-structured focus groups were conducted with 14 T2DM patients (71% male, aged 61-77 years) with a recent ACE. One focus group with partners (67% male, aged 64-75 years) was held. All interviews were transcribed verbatim and analyzed by two independent researchers. RESULTS: Patients believed that coping with an ACE differs between patients with and without T2DM. They had problems with physical exercise, sexuality and pharmacotherapy. Patients and partners were neither satisfied with the amount of information, especially on the combination of T2DM and ACE, nor with the support offered by healthcare professionals after discharge. Participants would appreciate tailored self-management support after discharge from hospital. CONCLUSIONS: Patients with T2DM and their partners lack tailored support after a first ACE. Our findings underpin the ADA recommendations to improve the transition from hospital to home. The results of our study will help to determine the exact content of a self-management support program delivered at home to help this specific group of patients to cope with both conditions.