The effectiveness of a graphical presentation in addition to a frequency format in the context of familial breast cancer risk communication:a multicenter controlled trial

Background: Inadequate understanding of risk among counselees is a common problem in familial cancer clinics. It has been suggested that graphical displays can help counselees understand cancer risks and subsequent decision-making. We evaluated the effects of a graphical presentation in addition to a frequency format on counselees' understanding, psychological well-being, and preventive intentions. Design: Multicenter controlled trial. Setting: Three familial cancer clinics in the Netherlands. Methods: Participants: Unaffected women with a breast cancer family history (first-time attendees). Intervention: Immediately after standard genetic counseling, an additional consultation by a trained risk counselor took place where women were presented with their lifetime breast cancer risk in frequency format (X out of 100) (n = 63) or frequency format plus graphical display (10 x 10 human icons) (n = 91). Main outcome measures: understanding of risk (risk accuracy, risk perception), psychological well-being, and intentions regarding cancer prevention. Measurements were assessed using questionnaires at baseline, 2-week and 6-month follow-up. Results: Baseline participant characteristics did not differ between the two groups. In both groups there was an increase in women's risk accuracy from baseline to follow-up. No significant differences were found between women who received the frequency format and those who received an additional graphical display in terms of understanding, psychological well-being and intentions regarding cancer prevention. The groups did not differ in their evaluation of the process of counseling. Conclusion: Women's personal risk estimation accuracy was generally high at baseline and the results suggest that an additional graphical display does not lead to a significant benefit in terms of increasing understanding of risk, psychological well-being and preventive intentions

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods and design</p> <p>Six hundred patients with T2DM (45 ≤ 75 years) who receive care in a structured diabetes care system, HbA1c ≥ 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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN84568563</p

Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316]

<p>Abstract</p> <p>Background</p> <p>Many patients with type 2 diabetes (T2DM) are not able to reach the glycaemic target level of HbA1c < 7.0%, and therefore are at increased risk of developing severe complications. Transition to insulin therapy is one of the obstacles in diabetes management, because of barriers of both patient and health care providers. Patient empowerment, a patient-centred approach, is vital for improving diabetes management. We developed a web-based self-management programme for insulin titration in T2DM patients. The aim of our study is to investigate if this internet programme helps to improve glycaemic control more effectively than usual care.</p> <p>Methods/Design</p> <p>T2DM patients (n = 248), aged 35–75 years, with an HbA1c ≥ 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self-titrating insulin. The control group will receive usual care.</p> <p>Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle.</p> <p>Discussion</p> <p>An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy.</p> <p>Trial registration</p> <p>Dutch Trial Register TC1316.</p

Improved glycaemic control in type 1 diabetes patients following participation per se in a clinical trial - mechanisms and implications

The phenomenon of improved diabetes self-management following participation in a clinical trial, with subsequent improvement of glycaemic control, has been acknowledged in literature but has received little attention. Also, the potential implications of such a 'study effect' for clinical research are poorly explored. We review the literature and describe the effects on glycaemic and psychological outcomes in long-term poorly controlled type 1 diabetes patients participating in a qualification phase of a Good Clinical Practice (GCP) trial. Improved glycaemic control following participation in a clinical trial is best understood as the result of improved patients' instrumental coping behaviours, including increased self-monitoring of blood glucose (SMBG). Such improvement in self-care with ensuing improved glycaemic control has important consequences for trial design. Firstly, benefits seen in uncontrolled trials should be interpreted with extreme caution. Secondly, unspecific study effects and the effect of a given intervention may not simply be additive. Therefore, it is wise to include a run-in or qualification phase of adequate length before randomization in a clinical trial. A stable baseline HbA(1c) can thus be reached, upon which the specific effect of an intervention can be properly judged. Also, in a multi-centre trial, a qualification phase of sufficient length will help diminish differences in terms of intensity of care provided in participating centres. Copyright (C) 2003 John Wiley Sons, Lt

A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control.

OBJECTIVE: To assess in a randomized crossover trial the efficacy of continuous subcutaneous insulin infusion in improving glycemic control and health-related quality of life in type 1 diabetic patients with long-standing poor glycemic control. RESEARCH DESIGN AND METHODS: A total of 79 patients in 11 Dutch centers were randomized to 16 weeks of continuous subcutaneous insulin infusion followed by 16 weeks intensive injection therapy or the reverse order. Glycemic control was assessed by HbA(1c), self-reported hypoglycemic events, and blood glucose memory meter read outs. Changes in quality of life were assessed by self-report questionnaires administered at baseline and 16 weeks. RESULTS: As the drop-out rate after crossover was high (17 of 79 patients [22%]), we analyzed the trial as a parallel clinical trial, using data of the first half of the crossover phase only. At 16 weeks, mean HbA(1c) was 0.84% (95% CI -1.31 to -0.36) lower in the continuous subcutaneous insulin infusion group compared with the insulin injection group (P = 0.002). Stability of blood glucose self-measurement values, expressed as SD of the nine-point blood glucose profiles, improved in the insulin pump group by 29.3 +/- 41.1 vs. 8.2 +/- 36.5% in the injection group (P = 0.039). The number of mild hypoglycemic episodes per patient-week was 0.99 (95% CI 0.11-1.87) higher in the insulin pump group (P = 0.028). Weight gain was similar in both groups. Scores on the Short-Form 36-Item subscales 'general health' and 'mental health' improved in the continuous subcutaneous insulin infusion group, compared with stable values in the injection group (P = 0.048 and 0.050, respectively). CONCLUSIONS: Continuous subcutaneous insulin infusion improves glycemic control and some aspects of health-related quality of life in patients with a history of long-term poor glycemic control

Clinical prediction model to characterize pulmonary nodules: Validation and added value of18F-fluorodeoxyglucose positron emission tomography

Background: The added value of 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning as a function of pretest risk assessment in indeterminate pulmonary nodules is still unclear. Objective: To obtain an external validation of the prediction model according to Swensen and colleagues, and to quantify the potential added value of FDC-PET scanning as a function of its operating characteristics in relation to this prediction model, in a population of patients with radiologically indeterminate pulmonary nodules. Design, setting, and patients: Between August 1997 and March 2001, all patients with an indeterminate solitary pulmonary nodule who had been referred for FDG-PET scanning were retrospectively identified from the database of the PET center at the VU University Medical Center. Results: One hundred six patients were eligible for the study, and 61 patients (57%) proved to have malignant nodules. The goodness-of-fit statistic for the model (according to Swensen) indicated that the observed proportion of malignancies did not differ from the predicted proportion (p = 0.46). PET scan results, which were classified using the 4-point intensity scale reading, yielded an area under the evaluated receiver operating characteristic curve of 0.88 (95% confidence interval [CI], 0.77 to 0.91). The estimated difference of 0.095 (95% CI, -0.003 to 0.193) between the PET scan results classified using the 4-point intensity scale reading and the area under the curve (AUC) from the Swensen prediction was not significant (p = 0.058). The PET scan results, when added to the predicted probability calculated by the Swensen model, improves the AUC by 13.6% (95% CI, 6 to 21; p = 0.0003). Conclusion: The clinical prediction model of Swensen et al was proven to have external validity. However, especially in the lower range of its estimates, the model may underestimate the actual probability of malignancy. The combination of visually read FDG-PET scans and pretest factors appears to yield the best accuracy

Microvascular disease in type 1 diabetes alters brain activation: A functional magnetic resonance imaging study

Individuals with type 1 diabetes have mild performance deficits on a range of neuropsychological tests compared with nondiabetic control subjects. The mechanisms underlying this cognitive deterioration are still poorly understood, but chronic hyperglycemia is now emerging as a potential determinant, possibly through microvascular changes in the brain. In 24 type 1 diabetic patients, we tested at euglycemia and at acute hypoglycemia whether the presence of proliferative diabetic retinopathy, as a marker of microvascular disease, adversely affects the ability of the brain to respond to standardized hypoglycemia, using functional magnetic resonance imaging with a cognitive task. Patients with retinopathy, compared with patients without, showed less deactivation (hence, an increased response) in the anterior cingulate and the orbital frontal gyrus during hypoglycemia compared with euglycemia (P < 0.05). Task performance and reaction time were not significantly different for either group. We conclude that microvascular damage in the brain of patients with retinopathy caused this increased brain response to compensate for functional loss