OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?

INTRODUCTION: Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives. METHODS: Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores). RESULTS: One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period. CONCLUSION: Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.

An example of clinical controversy related to evidence-based medecine / Un exemple de controverse en clinique liée à l'EBM

An example of clinical controversy related to EBM. The DCCT study for type 1 diabetes (1993) and UKPDS for type 2 (1998) had demonstrated the benefit of the hypoglycemic treatment with, for 1 point of HbA1c less, 30% less microangiopathy events. The cardiovascular benefit was less obvious, as these studies were performed in patients with primary prevention. The benefit became significant only during the follow-up, 10 years after the end of the study. After these results, it became unethical to consider randomized studies in which patients in the control group would have HbA1c greater than or equal to 8%. More recent studies in type 2 diabetics with a very high cardiovascular risk therefore compared "intensive" treatment to "good" treatment. The "super intensive" treatment of the ACCORD study, with an objective of HbA1c lower than 6%, resulted in increased mortality leading to premature discontinuation of the study. The excess cardiovascular mortality was correlated with the occurrence of very severe hypoglycaemia, three times more frequent in the "super intensive" group. In contrast to the concept "the lower is the better", patients with high cardiovascular risk should avoid the risk of severe hypoglycaemia secondary to treatment. In addition, the drug industry was asked to demonstrate the cardiovascular safety of the new antidiabetic molecules, regardless of their hypoglycemic effect, by conducting randomized double-blind studies with an identical target of HbA1c between the two groups. The adaptation of glycemic targets to cardiovascular risk in case of risk of hypoglycemia on the one hand, and the poor understanding of the methodology of cardiovascular safety studies on the other hand, have led to a radical questioning of the benefit of treating hyperglycemia with potentially serious consequences for patients.

Un exemple de controverse en clinique liée à L'EBM. Les études DCCT pour le diabète de type 1 (1993) et UKPDS pour le type 2 (1998) avaient apporté la preuve du bénéfice du traitement hypoglycémiant avec, pour 1 point d'hémoglobine glyquée (HbA1c) en moins, 30 % en moins de survenue d'évènements de microangiopathie. Le bénéfice cardiovasculaire était moins évident, ces études ayant été réalisées chez des patients en prévention primaire. Le bénéfice ne devenait significatif que lors du suivi, 10 ans après la fin de l'étude. Après ces résultats, il devenait non éthique d'envisager des études randomisées dont les patients du groupe contrôle auraient une HbA1c supérieure ou égale à 8 %. Les études plus récentes réalisées chez des diabétiques de type 2 à très haut risque cardiovasculaire ont donc comparé un traitement « intensif ¼ à un « bon ¼ traitement. Le traitement « super intensif ¼ de l'étude ACCORD visant une HbA1c inférieure à 6 % a entraîné une augmentation de la mortalité provoquant l'arrêt prématuré de l'étude. La surmortalité cardiovasculaire était corrélée à la survenue d'hypoglycémies très sévères, trois fois plus fréquentes dans le groupe « super intensif ¼. À l'opposé du concept « the lower is the better ¼, il faut donc chez les patients à haut risque cardiovasculaire éviter le risque d'hypoglycémie sévère secondaire au traitement. De plus il a été demandé aux industriels de démontrer la sécurité cardiovasculaire des nouvelles molécules antidiabétiques, indépendamment de leur effet hypoglycémiant, en réalisant des études randomisées en double aveugle avec un objectif d'HbA1c identique entre les deux groupes. L'adaptation des objectifs glycémiques au risque cardiovasculaire en cas de risque d'hypoglycémie d'une part, et la mauvaise compréhension de la méthodologie des études de sécurité cardiovasculaire d'autre part ont suscité une remise en cause radicale du bienfait du traitement de l'hyperglycémie aux conséquences potentiellement graves pour les patients.

Breaking Barriers to Effective Type 2 Diabetes Management: Findings from the use of the OPTIMA© Questionnaire in Clinical Practice.

BACKGROUND: The OPTIMA© (MSD, Courbevoie, France) questionnaire was developed to promote shared decisions and the set-up of specific micro-objectives in clinical practice by optimizing communication between type 2 diabetes (T2DM) patients and their physicians. The present study aimed to assess OPTIMA in clinical practice. METHODS: A cross-sectional multicenter observational study was conducted in France from 2012 to 2014. During routine consultation, patients completed one of the five modules of the OPTIMA questionnaire (Physical activity, Diet, Treatment, Knowledge of the disease or Self-monitoring of blood glucose). The rate of SMART (specific, measurable, acceptable, realistic, timely) micro-objective set-up following the use of the questionnaire was assessed. Data on how patients felt about their diabetes management (beliefs concerning actions, how easy they were to do and how often they were done in practice) were gathered. Finally, patients' and physicians' opinions on OPTIMA were assessed using the PRAgmatic Content and face validity Test (PRAC-Test© (Mapi, Lyon, France) evaluation questionnaire. RESULTS: Overall, 807 patients were included by 186 physicians. While 92.7 % of consultations led to the set-up of a micro-objective, only 22.3 % were SMART micro-objectives: Physical activity module (34.3 %), Diet module (9.6 %), Treatment module (16.4 %), Knowledge of the disease module (25.2 %), and self-monitoring of blood glucose module (29.5 %). Among patients completing the Physical activity module, 79.0 % reported that they believed physical activity was useful, 35.0 % that it was easy, and 25.8 % that they regularly practised it. PRAC-Test results showed that OPTIMA was a useful and easy-to-use questionnaire that promotes communication between physicians and their patients according to 92.8 % of patients and 69.4 % of physicians. CONCLUSION: The OPTIMA questionnaire facilitates communication between patients and their physicians and promotes the set-up of micro-objectives concerning T2DM management. The Physical activity module was the most likely of the five modules in the questionnaire to lead to the set-up of SMART micro-objectives. FUNDING: MSD France.

[Hyperglycemia and cardiovascular risk: lessons from randomized trials]. / Hyperglycémie et risque cardiovasculaire: bilan des grandes études.

Diabetes is a major cardiovascular risk factor However, hyperglycemia is much more closely associated with microangiopathy than with macrovascular complications. Epidemiologic studies have shown a 15% increase of myocardial infarction for 1% increase in HbA1c level. It is accepted but not absolutely demonstrated, that reduction of HbA1c results in an equal reduction of cardiovascular events. An initial good glycemic control has long-term benefical effects on the risk of cardiovascular disease. On the contrary, benefit of an intensive glucose control is not demonstrated in diabetic patients with previous myocardial infarction. Two recent studies (ACCORD and VADT) showed an increase of cardiovascular mortality by severe hypoglycemia. In diabetic patients with previous myocardial infarction, glycemic goal must be modulated by the hypoglycaemic risk. A goal of 7.5% HbA1c seems reasonable for the diabetic patients treated by sulfonylureas or insulin, at risk of hypoglycaemia. HbA1c target < 7% remains the general goal and HbA1c target < 6.5% is appropriated to the patients treated by insulin sensitizing medications without risk of hypoglycaemia.

[Thoughts about patient education: the experience of diabetes]. / Réflexion sur l'éducation thérapeutique : l'expérience du diabète.

Patient education is not simply information or teaching or coaching. It is learning that is both practical and specialized, intended to help patients acquire therapeutic skills and to support them in changing their self-care practices to attain personalized objectives. It is therapeutic. An effective strategy to overcome health problems requires that patients not avoid the problem by denying the disease. Health prevention behavior requires that the patient be simultaneously confident in the prescribed treatments and able to project into the future. It is more difficult for asymptomatic patients to have a mental representation of the disease and thus be able to modify their lifestyle. Self-measurement of blood glucose can create anxiety and make the risk of complications more tangible, but it is beneficial only if it induces action or reassurance. Changing behavior is possible only to the extent that it does not challenge the patient's own well-being. It may be unreasonable but it is also rational to refuse what the patient perceives as a threat to his or her own identity. Thus, physicians caring for patients with a chronic disease must be skilled in three different fields: biomedicine, pedagogy, and psychology.

Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes.

AIMS/HYPOTHESIS: Intra-abdominal fat (IAF) and inflammatory markers are correlated with cardio-vascular risk. We compared the impact of bed-time insulin versus pioglitazone treatment on these parameters in type 2 diabetic (T2D) patients. METHODS: Twenty-eight T2D patients poorly controlled with metformin and sulfonylurea were randomized to receive add-on therapy with pioglitazone or bed-time NPH insulin. IAF and subcutaneous fat (SCF) content, systemic low-grade inflammation level and expression of inflammation related genes in SCF, were measured before and after 24 weeks of treatment. RESULTS: Insulin and pioglitazone resulted in a significant decrease in HbA1c (-1.6% and -1.2%, respectively) and a significant increase in total body fat mass (1+/-2.3 and 3.3+/-2.7 kg, respectively). There was no change in IAF content after both treatments whereas significant increase in SCF content was only seen after pioglitazone treatment (p<0.05 versus insulin). hsCRP level decreased after pioglitazone and ferritin level decreased after insulin treatment. No change in mRNA expression of inflammation related genes was found after either treatment. CONCLUSION/INTERPRETATION: This suggests that a 24-week treatment with pioglitazone or bed-time insulin has a similar impact on intra-abdominal fat mass and systemic low-grade inflammation.

Intensive cardiovascular risk factors therapy and prevalence of silent myocardial ischaemia in patients with type 2 diabetes.

BACKGROUND: Screening for silent myocardial ischaemia (SMI) is a controversial strategy undergoing intensive risk factor therapy. AIMS: To assess the prevalence of SMI and coronary artery disease (CAD) in asymptomatic type 2 diabetic patients at high cardiovascular risk (two additional risk factors or more) and undergoing long-term intensive risk factor therapy and tight glycaemic control. METHODS: SMI screening, using isotopic or echographic stress tests, was carried out in 122 asymptomatic type 2 diabetic patients at high cardiovascular risk and undergoing long-term intensive risk factor therapy. Coronary angiography was proposed if SMI was detected. Long-term follow-up data on death, myocardial infarction and revascularization were obtained by telephone call or clinical review. RESULTS: The mean age was 65+/-6 years and 74% of patients were men. The mean duration of diabetes was 15+/-9 years. The mean number of additional risk factors was 2.9, 32% of patients had microalbuminuria and 12% had peripheral arterial disease. SMI was detected in 20 (16%) patients. Seven (6%) patients had significant CAD treated successfully by angioplasty (n=6) or bypass surgery (n=1). The positive predictive value of the non-invasive screening test for the diagnosis of significant CAD (stenosis>50%) was 39%. The event rate was very low (1.6%) at 2-year follow-up. CONCLUSION: Long-term intensive risk factor therapy in high-risk patients with type 2 diabetes is associated with low prevalence of SMI and detected CAD. Optimal medical therapy and revascularization of significant CAD are associated with a low cardiovascular event rate at two years.

Screening for liver fibrosis by using a noninvasive biomarker in patients with diabetes.

BACKGROUND & AIMS: Patients with diabetes are at risk for nonalcoholic fatty liver disease leading to advanced fibrosis, cirrhosis, and liver cancer. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) in patients with diabetes. METHODS: We prospectively studied 1131 consecutive patients without a history of liver disease seen for diabetes. The biomarker data were obtained, and patients with presumed advanced fibrosis were reinvestigated by a hepatologist using elastography and, if necessary, ultrasonography, endoscopy, or liver biopsy. RESULTS: The biomarker predicted advanced fibrosis in 63 of 1131 (5.6%) patients. A total of 45 patients was reinvestigated, and advanced fibrosis was confirmed in 32 patients, a 2.8% (32/1131) prevalence of confirmed advanced fibrosis, 5 cases of cirrhosis, and 4 cases of hepatocellular carcinoma. In the population with type 2 diabetes who were 45 years or older, the prevalence of confirmed advanced fibrosis was 4.3% (30/696), and hepatocellular carcinoma was 5.7 of 1000 (4/696). CONCLUSIONS: The fibrosis biomarker might be used for the detection of advanced fibrosis in patients with type 2 diabetes.

Lowering of brachial pulse pressure in 9379 hypertensives with type 2 diabetes and reduction of cardiovascular events.

OBJECTIVES: Pulse pressure (PP) is a major risk factor for cardiovascular (CV) events, mainly in diabetic hypertensives. The objectives of the study were to determine which clinical characteristics could predict the fall in PP and the reduction of CV events under treatment. Design and methods. Type 2 diabetic hypertensives (n = 9379) with PP>60 mmHg (mean age 64 years) were included in a cohort study. During the 9 months follow-up, the physician in charge was asked to reinforce treatment in order to lower PP, using preferentially a fixed low-dose perindopril/indapamide combination. RESULTS: After 9 months, PP had fallen by 9.1+/-0.2 mmHg (p<0.001). Multivariate analysis of the determinants of PP reduction showed a significant positive association with administration of fixed ACEI/diuretic combination (p<0.001) and a negative association with glycated hemoglobin (p<0.01). During the 9 months follow-up, 632 CV events occurred. In multivariate analysis, the administration of fixed perindopril/indapamide combination was associated with a lower incidence of CV events (OR = 0.64 [0.48-0.86], p<0.01), independently of CV risk factors. CONCLUSIONS: The reinforcement of therapeutic measures made possible the reduction of PP in type 2 diabetic hypertensives, under conditions of usual care. Administration of a fixed perindopril/indapamide combination therapy was associated with an independent reduction of CV events.

Rosiglitazone for nonalcoholic steatohepatitis: one-year results of the randomized placebo-controlled Fatty Liver Improvement with Rosiglitazone Therapy (FLIRT) Trial.

BACKGROUND & AIMS: Nonalcoholic steatohepatitis (NASH) is a liver disease that complicates insulin-resistant states. This trial tested the efficacy and safety of rosiglitazone, an insulin-sensitizing agent, in patients with NASH. METHODS: Sixty-three patients with histologically proven NASH were randomly assigned to receive rosiglitazone (4 mg/day for the first month and 8 mg/day thereafter; n = 32) or placebo (n = 31) for 1 year. Liver biopsy was performed at the end of treatment. End points were improvement in the histologic score of steatosis, normalization of serum transaminase levels, and improvement in necroinflammation and fibrosis. RESULTS: More patients treated with rosiglitazone than receiving placebo had improved steatosis (47% vs 16%; P = .014) and normalized transaminase levels (38% vs 7%; P = .005), although only half of patients responded. There was no improvement in other histologic lesions, including fibrosis, and a composite score of activity, the nonalcoholic fatty liver disease activity score. Improvement of steatosis correlated with reduction of transaminase levels (r = 0.36; P < .005), improvement in insulin sensitivity (r = 0.34; P = .008), and increase in adiponectin levels (r = -0.54; P < .01) but not with weight variations. Independent predictors of response were rosiglitazone treatment, the absence of diabetes, and massive steatosis. Weight gain was the main adverse effect (mean gain of 1.5 kg in the rosiglitazone group vs -1 kg in the placebo group; P < .01), and painful swollen legs was the main reason for dose reduction/discontinuation. Serum hemoglobin level was slightly but significantly reduced. There was no hepatic toxicity. CONCLUSIONS: In patients with NASH, rosiglitazone improves steatosis and transaminase levels despite weight gain, an effect related to an improvement in insulin sensitivity. However, there is no improvement in other parameters of liver injury.