Ivo Rakovac

Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data

BACKGROUND Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. METHODS We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. FINDINGS Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. INTERPRETATION Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. FUNDING UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Long-term evaluation of a structured outpatient education programme for intensified insulin therapy in patients with Type 1 diabetes: a 12-year follow-up

Aims/hypothesisThis study was conducted to evaluate the long-term outcome of a structured outpatient diabetes teaching and treatment programme (DTTP) for intensified insulin therapy in patients with Type 1 diabetes, which aims to improve metabolic control without increasing the risk of severe hypoglycaemia.MethodsAll 123 diabetic outpatients (age 41±14 years; 64 women; BMI 23.5±3.1; diabetes duration 17±11 years; HbA1c 7.9±1.6%; 32 patients with a history of severe hypoglycaemia; 18 with overt nephropathy; 22 with proliferative retinopathy) who participated in the DTTP between June 1989 and June 1990 were invited for follow-up visits after 3, 6 and 12 years.ResultsOut of the 123 patients, 11 died during the follow-up period, two were lost for follow-up, and one was not willing to participate in re-evaluation after 12 years. Mean HbA1c levels decreased from 7.9±1.6% to 7.1±1.2% (p<0.01) after 3 years, and were 7.8±1.5% (NS) and 7.8±1.2% (NS) after 6 and 12 years respectively. Frequency of hypoglycaemia decreased from 0.49 episodes per patient per year to 0.14 after 3 years (p<0.01), 0.19 after 6 years (p<0.01) and 0.16 after 12 years (p<0.01). Of the participants, 41% were able to lower HbA1c levels without episodes of severe hypoglycaemia and to maintain this improvement at all follow-up visits over the 12-year period. At follow-up, intensified insulin therapy was carried out by 94% of the patients.Conclusions/interpretationA sustained reduction of the incidence of severe hypoglycaemia was observed in patients with Type 1 diabetes after participation in a structured outpatient DTTP over a 12-year period.

Self-management of oral anticoagulation reduces major outcomes in the elderly - A randomized controlled trial

Although many patients with long-term oral anticoagulation (OAC) can manage their medication safely and reliably themselves, no study on elderly patients has as yet assessed the safety and efficacy of OAC self-management with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients aged 60 years or more were randomised into a self-management (SMG) (N = 99) or routine care group (RCG) (N = 96). The primary outcome was the combined endpoint of all thromboembolic events requiring hospitalisation and all major bleeding complications. Mean follow-up was 2.9 +/- 1.2 and 3.0 +/- 1.1 years in the SMG and RCG, respectively. In intention-to-treat analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p = 0.049). The post-hoc analysis on OAC treatment sensitivity supported the benefit of self-management (HR 0.27; 95% CI: 0.13 to 0.71; p = 0.006). Fifteen patients in the SMG died during the study, but none of the deaths was directly associated with anticoagulation therapy. In the RCG, 11 patients died; of those, three deaths were directly associated with anticoagulation therapy and there was one death of unknown cause. During follow-up, the quality of OAC control was significantly better in the SMG than in the RCG. In elderly patients, long-term self-management of oral anticoagulation is superior for the prevention of major thromboembolic and bleeding complications and for the quality of oral anticoagulation control compared to routine care for a mean follow-up period of three years.

Self-management of oral anticoagulation in the elderly: Rationale, design, baselines and oral anticoagulation control after one year of follow-up - A randomized controlled trial

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes. In this multi-centre, open, randomised controlled trial, patients aged 60 years or more were randomised into the self-management group (SMG) (N = 99) or routine care group (RCG) (N = 96). We describe the rationale, design, baseline characteristics and interim analyses of oral anticoagulation control quality within the first year of follow-up. The medians of the squared international normalised ratio (INR) value deviations after six and 12 months were significantly lower in the SMG with medians of 0.16 and 0.16 compared to the RCG with medians of 0.25 and 0.25. The percentage of time within target range and the percentage of INR measurements within target range were significantly higher in the SMG versus the RCG within the first six months (medians 71% vs. 58% and 69% vs. 57%), and during the second six months of the study (75% vs. 67% and 72% vs. 57%). The numbers of all thromboembolic events requiring hospitalisation, major bleeding events, and deaths were similar in both groups. These preliminary results suggest that self-management of oral anticoagulation is safe and feasible for elderly patients willing to participate in a structured training programme.

Attitudes Towards Insulin Pump Therapy Among Adolescents and Young People

PURPOSE This study investigated reasons for the rejection and discontinuation of insulin pump therapy and explored general attitudes towards this mode of therapy among young patients with type 1 diabetes. METHODS A questionnaire was developed using a focus group of young people with diabetes. It was then used to survey a random sample of adolescents and young people identified by physicians specializing in diabetes care and participating in a voluntary quality improvement initiative in Germany. The physicians were also surveyed. RESULTS Eighty-eight patients participated in the survey (22 had never used the pump, 20 had formerly used the pump, and 46 were using the pump at that time, with an average age of between 20 and 22 years, depending on the group). Those who had never used the pump had had diabetes for a significantly shorter length of time and had undergone their first diabetes education more recently. Current pump users were significantly younger at the time of the first diabetes education. There were no significant differences between patients concerning where they obtained their information about the condition and treatment options. Although clinical factors were named, social and psychological factors were prominent as reasons both in reluctance to try the pump therapy and in discontinuing therapy. Technical problems as a disadvantage of the pump (aside from the catheter) were less likely to be named. Responses among physicians confirmed discipline and compliance were essential prerequisites for this therapy and supported findings that patients discontinuing pump therapy at their own request tend to do so for nonclinical reasons. CONCLUSIONS Although the technical reliability of the insulin pump was generally accepted by all patients regardless of current treatment, clinical disadvantages relating to the use of the pump but more commonly social/psychological factors were named, which resulted in patients being reluctant to try this therapy or discontinuing use of it.

Effects of a multifaceted educational program on blood pressure and cardiovascular risk in hypertensive patients: the Austrian herz.leben project.

Objective Although hypertension is the most prevalent risk factor for cardiovascular and cerebrovascular morbidity and mortality, the level of blood pressure control remains poor. To amplify quality of care in hypertensive patients, a multifaceted program consisting of structured educational programs for both patients and staff, structured documentation and feedback reports with peer comparison, was implemented on a multicentre basis. Main targets were improvement of blood pressure control and reduction of cardiovascular risk. A provisional reimbursement was provided. Methods Patients were eligible for inclusion in the program if office blood pressure was uncontrolled (>160/95 or >140/90 mmHg) in addition to elevated cardiovascular risk [>15% according to the New Zealand Risk Score (NZRS)]. Blood pressure and lipid panels were measured at entry in the program and after 12 months. Patients attended four educational units held by hypertension nurses and physicians. All data were collected in structured documentation sheets and benchmarking reports were provided every 6 months. Results Two thousand and forty-one patients were enrolled in the program within 5 years and 3 months; 54% female, age 62.8 ± 11.1years, BMI 29.50 ± 7.88 kg/m2 (mean ± SD). To date, 744 patients have been seen at 1-year follow-up. Entry blood pressure was 156.1 ± 20.8/88.9 ± 11.1 mmHg. Total cholesterol showed mean levels of 207.0 ± 46.0 mg/dl, low-density lipoprotein 122.3 ± 41.6 mg/dl, high-density lipoprotein 57.2 ± 22.4 mg/dl and calculated cardiovascular risk level (NZRS) was 17.28 ± 8.29%. One year following the educational program, blood pressure was reduced to 139.2 ± 15.6 (P < 0.001)/82.1 ± 9.5 mmHg (P < 0.001). NZRS (14.1 ± 7.2%; P < 0.001) and BMI (29.26 ± 4.92 versus 29.06 ± 4.99) also improved significantly. Conclusion This structured educational program showed its ability to improve intermediate outcomes in hypertensive patients. Better blood pressure control and significant reduction of the individual cardiovascular risk profile were achieved. A broad implementation of the program in the management of hypertension seems justified.

Screening of depression in patients with diabetes mellitus

Objectives: The first aim of this study was to compare the effectiveness of four commonly used depression screening measures for medically ill populations in identifying depression within a diabetes sample. The second aim was to examine whether the inclusion of a measure for physical symptoms specific to diabetes is also necessary for a diagnosis of depression or alternatively whether any overlap would obscure the effect on the screening measure for depression. Research Design and Methods: One hundred fifty patients with Type 2 diabetes in two large public hospital outpatient clinics completed a questionnaire which included the Center for Epidemiological Studies—Depression Scale (CES-D), the Silverstone Concise Assessment for Depression (SCAD), the Hospital Anxiety and Depression Scale (HADS), and the Depression in the Medically Ill (DMI) Questionnaire. Patient scores on these questionnaires were then assessed against their responses on the Composite International Diagnostic Interview Short Form and the Diabetes Symptom Checklist to determine their effectiveness. Results and Conclusions: Logistic regression and receiver operating curves analysis, including areas under the curves, suggested selecting the CES-D, rather than the DMI-10, HADS or SCAD for screening for depression in a Type 2 diabetic patient. The CES-D performed well at predicting depression, had high sensitivity and specificity, and did not require the addition of diabetes symptoms to aid in diagnosis.

Gesundheitsstatus der Typ-2-Diabetiker in Österreich aus der Sicht einer Qualitätssicherungs-Initiative

SummaryOBJECTIVE: To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS: Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS: Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 ± 11.5 years old, with an average diabetes duration of 8.0 ± 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS: Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.ZusammenfassungZIELSETZUNG: Ziel dieser Arbeit ist es, die Prävalenz von diabetischen Spätkomplikationen unter österreichischen Patienten mit Diabetes Mellitus Typ 2 anhand von im Rahmen einer Qualitätssicherungs-Initiative gewonnenen Daten zu bestimmen. METHODIK: Analyse der Daten aller Personen mit diagnostiziertem Diabetes Mellitus Typ 2, die in der Datenbank des Forums für Qualitätssicherung in der Diabetologie Österreich (FQSD-Ö) zwischen 1.1.1997 und 1.9.2007 dokumentiert wurden. ERGEBNISSE: Insgesamt wurden 23.641 Patienten mit Typ-2-Diabetes dokumentiert. Die Patienten waren im Schnitt 66,3 ± 11,5 Jahre alt, mit einer Diabetesdauer von 8,0 ± 8,5 Jahren. Von Blindheit waren 0,9 %, von einer Amputation 2,3 %, von Herzinfarkt oder Bypass 12,2 %, von Schlaganfall 8,7 % und von Nierenversagen 0,8 % der Patienten betroffen. SCHLUSSFOLGERUNGEN: Die Prävalenz der diabetischen Spätkomplikationen in der ausgewerteten österreichischen Population ist hoch, jedoch vergleichbar mit anderen europäischen Ländern. Die Behandlung von Patienten mit Diabetes in Österreich muss weiterhin optimiert werden, um das Auftreten von Spätschäden zu vermindern.OBJECTIVE To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 +/- 11.5 years old, with an average diabetes duration of 8.0 +/- 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.

[Health status of type 2 diabetics in Austria - perspective of a quality improvement initiative].

SummaryOBJECTIVE: To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS: Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS: Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 ± 11.5 years old, with an average diabetes duration of 8.0 ± 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS: Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.ZusammenfassungZIELSETZUNG: Ziel dieser Arbeit ist es, die Prävalenz von diabetischen Spätkomplikationen unter österreichischen Patienten mit Diabetes Mellitus Typ 2 anhand von im Rahmen einer Qualitätssicherungs-Initiative gewonnenen Daten zu bestimmen. METHODIK: Analyse der Daten aller Personen mit diagnostiziertem Diabetes Mellitus Typ 2, die in der Datenbank des Forums für Qualitätssicherung in der Diabetologie Österreich (FQSD-Ö) zwischen 1.1.1997 und 1.9.2007 dokumentiert wurden. ERGEBNISSE: Insgesamt wurden 23.641 Patienten mit Typ-2-Diabetes dokumentiert. Die Patienten waren im Schnitt 66,3 ± 11,5 Jahre alt, mit einer Diabetesdauer von 8,0 ± 8,5 Jahren. Von Blindheit waren 0,9 %, von einer Amputation 2,3 %, von Herzinfarkt oder Bypass 12,2 %, von Schlaganfall 8,7 % und von Nierenversagen 0,8 % der Patienten betroffen. SCHLUSSFOLGERUNGEN: Die Prävalenz der diabetischen Spätkomplikationen in der ausgewerteten österreichischen Population ist hoch, jedoch vergleichbar mit anderen europäischen Ländern. Die Behandlung von Patienten mit Diabetes in Österreich muss weiterhin optimiert werden, um das Auftreten von Spätschäden zu vermindern.OBJECTIVE To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 +/- 11.5 years old, with an average diabetes duration of 8.0 +/- 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.

Growing inequalities in child injury deaths in Europe

In this short report, we describe and compare mortality data for injuries in children aged <15 years in the WHO European region as estimated by the WHO Global Health Estimates for 2000 and 2011. Child injury deaths have decreased overall. Mortality rate ratios between low- and middle-income countries (LMIC) and high-income countries in the region show an increase in relative inequalities for childhood deaths from unintentional injuries and a narrowing from intentional injury. This growing inequality in unintentional injury is a public health concern and calls for renewed efforts to reduce childhood injuries in LMIC the region.