Shared decision making in primary care: Process evaluation of the intervention in the OPTIMAL study, a cluster randomised trial.

AIMS: To analyse the performance of a Shared Decision Making (SDM) intervention, we assessed perceived and experienced SDM in General Practitioners (GPs) and patients with type 2 diabetes (T2DM). METHODS: Cluster-Randomised Controlled Trial (cRCT) testing the effect of a decision aid. Opinions and experienced role regarding SDM were assessed in 72 patients and 18 GPs with the SDM-Q-9 (range 0-45) and Control Preferences Scale (CPS, 0-5), and observed SDM with the OPTION5 (0-20). SDM at baseline was compared to 24 months' follow-up using paired t-tests. RESULTS: At baseline, perceived levels of SDM did not significantly differ between GPs and patients with T2DM (difference of 2.3, p = 0.24). At follow-up, mean patients' perceived level of SDM was 7.9 lower compared to baseline (p < 0.01), whereas GPs' opinions had not changed significantly. After both visits, mean CPS scores differed significantly between patients and GPs. OPTION5 scores ranged between 6 and 20. CONCLUSION: Patients and GPs perceived similar baseline levels of SDM. Two years later, patients perceived less SDM, while GPs did not change their opinion. SDM was appropriate immediately after training, but perhaps GPs fell back in old habits over time. We recommend repeated SDM training.

Population-based screen-detected type 2 diabetes mellitus is associated with less need for insulin therapy after 10 years.

INTRODUCTION: With increased duration of type 2 diabetes, most people have a growing need of glucose-lowering medication and eventually might require insulin. Presumptive evidence is reported that early detection (eg, by population-based screening) and treatment of hyperglycemia will postpone the indication for insulin treatment. A treatment legacy effect of population-based screening for type 2 diabetes of about 3 years is estimated. Therefore, we aim to compare insulin prescription and glycemic control in people with screen-detected type 2 diabetes after 10 years with data from people diagnosed with type 2 diabetes seven (treatment legacy effect) and 10 years before during care-as-usual. RESEARCH DESIGN AND METHODS: Three cohorts were compared: one screen-detected cohort with 10 years diabetes duration (Anglo-Danish-Dutch study of Intensive Treatment in People with Screen-Detected Diabetes in Primary care (ADDITION-NL): n=391) and two care-as-usual cohorts, one with 7-year diabetes duration (Groningen Initiative to Analyze Type 2 Diabetes Treatment (GIANTT) and Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC): n=4473) and one with 10-year diabetes duration (GIANTT and ZODIAC: n=2660). Insulin prescription (primary outcome) and hemoglobin A1c (HbA1c) of people with a known diabetes duration of 7 years or 10 years at the index year 2014 were compared using regression analyses. RESULTS: Insulin was prescribed in 10.5% (10-year screen detection), 14.7% (7-year care-as-usual) and 19.0% (10-year care-as-usual). People in the 7-year and 10-year care-as-usual groups had a 1.5 (95% CI 1.0 to 2.1) and 1.8 (95% CI 1.3 to 2.7) higher adjusted odds for getting insulin prescribed than those after screen detection. Lower HbA1c values were found 10 years after screen detection (mean 50.1 mmol/mol (6.7%) vs 51.8 mmol/mol (6.9%) and 52.8 mmol/mol (7.0%)), compared with 7 years and 10 years after care-as-usual (MDadjusted: 1.6 mmol/mol (95% CI 0.6 to 2.6); 0.1% (95% CI 0.1 to 0.2) and 1.8 mmol/mol (95% CI 0.7 to 2.9); and 0.2% (95% CI 0.1 to 0.3)). CONCLUSION: Population-based screen-detected type 2 diabetes is associated with less need for insulin after 10 years compared with people diagnosed during care-as-usual. Glycemic control was better after screen detection but on average good in all groups.

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.

Metabolomic biomarkers for personalised glucose lowering drugs treatment in type 2 diabetes.

We aimed to identify metabolites to predict patients' response to glucose lowering treatment during the first 5 years after detection of type 2 diabetes. Metabolites were measured by GC-MS in baseline samples from 346 screen-detected type 2 diabetes patients in the ADDITION-NL study. The response to treatment with metformin and/or sulphonylurea (SU) was analysed to identify metabolites predictive of 5 year HbA1c change by multiple regression analysis. Baseline glucose and 1,5 anhydro-glucitol were associated with HbA1c decrease in all medication groups. In patients on SU no other metabolite was associated with HbA1c decrease. A larger set of metabolites was associated with HbA1c change in the metformin and the combination therapy (metformin + SU) groups. These metabolites included metabolites related to liver metabolism, such as 2-hydroxybutanoic acid, 3-hydroxybutanoic acid, 2-hydroxypiperidine and 4-oxoproline). Metabolites involved in oxidative stress and insulin resistance were higher when the HbA1c decrease was larger in the metformin/sulphonylurea group. The associations between baseline metabolites and responsiveness to medication are in line with its mode of action. If these results could be replicated in other populations, the most promising predictive candidates might be tested to assess whether they could enhance personalised treatment.

Dutch Translation and Psychometric Testing of the 9-Item Shared Decision Making Questionnaire (SDM-Q-9) and Shared Decision Making Questionnaire-Physician Version (SDM-Q-Doc) in Primary and Secondary Care.

PURPOSE: The SDM-Q-9 and SDM-Q-Doc measure patient and physician perception of the extent of shared decision making (SDM) during a physician-patient consultation. So far, no self-report instrument for SDM was available in Dutch, and validation of the scales in other languages has been limited. The aim of this study was to translate both scales into Dutch and assess their psychometric characteristics. METHODS: Participants were patients and their treating physicians (general practitioners and medical specialists). Patients (N = 182) rated their consultation using the SDM-Q-9, 43 physicians rated their consultations using the SDM-Q-Doc (N = 201). Acceptability, reliability (internal consistency), and the factorial structure of the instruments were determined. For convergent validity the CPSpost was used. RESULTS: Reliabilities of both scales were high (alpha SDM-Q-9 0.88; SDM-Q-Doc 0.87). The SDM-Q-9 and SDM-Q-Doc total scores correlated as expected with the CPSpost (SDM-Q-9: r = 0.29; SDM-Q-Doc: r = 0.48) and were significantly different between the CPSpost categories, with lowest mean scores when the physician made the decision alone. Principal Component Analyses showed a two-component model for each scale. A confirmatory factor analysis yielded a mediocre, but acceptable, one-factor model, if Item 1 was excluded; for both scales the best indices of fit were obtained for a one-factor solution, if both Items 1 and 9 were excluded. CONCLUSION: The Dutch SDM-Q-9 and SDM-Q-Doc demonstrate good acceptance and reliability; they correlated as expected with the CPSpost and are suitable for use in Dutch primary and specialised care. Although the best model fit was found when excluding Items 1 and 9, we believe these items address important aspects of SDM. Therefore, also based on the coherence with theory and comparability with other studies, we suggest keeping all nine items of the scale. Further research on the SDM-concept in patients and physicians, in different clinical settings and different countries, is necessary to gain a better understanding of the SDM-construct and its measurement.

Effect of six years intensified multifactorial treatment on levels of hs-CRP and adiponectin in patients with screen detected type 2 diabetes: the ADDITION-Netherlands randomized trial.

BACKGROUND: Levels of high-sensitivity C-reactive protein (hs-CRP) and adiponectin, reflecting chronic inflammation, are associated with cardiovascular disease in type 2 diabetes. The long-term effects of multifactorial therapy in type 2 diabetes patients on CRP and adiponectin are unknown. METHODS: The ADDITION-NL study is a randomized clinical trial among screen-detected type 2 diabetes patients, randomized to intensive treatment (HbA1c <7.0% (53 mmol/mol), blood pressure ≤135/85 mmHg, total cholesterol ≤3.5 mmol/L) or routine care. Hs-CRP and adiponectin were measured before and 1, 2 and 6 years after inclusion. We analysed the effectiveness of the intervention on hs-CRP and adiponectin levels using a mixed effects model, taking into account practice, baseline levels and different medications. RESULTS: A total of 424 patients were included (intensive care n = 235; routine care n = 189). Both groups were well matched. Body mass index, systolic blood pressure, total cholesterol and HbA1c improved significantly more in the intensive care group compared to routine care group. Levels of hs-CRP decreased significantly in both treatment groups over time. Mean hs-CRP in the routine care group was 24% higher (p = 0.0027) than in the intensive treatment group during follow-up. After an initial increase the adiponectin values levelled off to nearly baseline values in both groups. The difference between the two groups after 6 years was 0.44 µg/mL (p = 0.27). CONCLUSIONS: Intensified multifactorial treatment in type 2 diabetes results in an enhanced decrease in hs-CRP. Whether this is clinically meaningful remains uncertain. The link to adiponectin seems to be more complex.

Shared decision making in type 2 diabetes with a support decision tool that takes into account clinical factors, the intensity of treatment and patient preferences: design of a cluster randomised (OPTIMAL) trial.

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

New endoscopic techniques for obscure gastrointestinal bleeding.

The case of a postmenopausal woman with a congenital aortic stenosis is presented. She presented with severe iron deficiency anemia. After negative extensive gastrointestinal analysis, she was treated with octreotide for six months. After cessation of octreotide, anemia rapidly recurred. A second capsule endoscopy and a double balloon enteroscopy were performed, and an intestinal vascular malformation was found. After surgical segment resection, the patient had stable, normal levels of hemoglobin and no complaints after 14 months of follow-up.

Patients' and doctors' views on respiratory tract symptoms.

OBJECTIVE: To explore the views of patients and doctors on respiratory tract symptoms. DESIGN: Transversal survey among patients and general practitioners. SETTING: Primary health care and community. SUBJECTS: 51 patients attending a general practitioner, 38 patients in the community, 7 general practitioners. MAIN OUTCOME MEASURES: Patients' and doctors' views on respiratory tract symptoms and differences between them: agreement with statements rated on a 5-point scale, ranging from "strongly disagree" to "strongly agree." RESULTS: Patients less than doctors endorsed the self-limiting character of cough, sore throat and earache (mean 3.1, 3.4 and 2.9 versus 4.1, 4.1 and 3.7) and patients--much more than doctors--rated antibiotics as being necessary for cough and sore throat (mean 2.7 and 2.9 versus 1.7 and 17) and believed that antibiotics speed recovery (mean 3.7 versus 2.0). However, there was little difference relating to the necessity to see a doctor after some time period. CONCLUSION: Patients appeared to differ from doctors in views on respiratory tract symptoms. The results stress the importance of exploring patients' views when being confronted by patients suffering from respiratory tract symptoms.