Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials

BACKGROUND: Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories. METHODS: In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance. RESULTS: Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%. With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients. CONCLUSION: Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has to be modified because of the increased standard deviation. This approach is suitable to enable economic evaluation with lower costs to both study participants and investigators. TRIAL REGISTRATION: The trial registration number is ISRCTN0289374

Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial

BACKGROUND: Aged patients with coronary heart disease (CHD) have a high prevalence of co-morbidity associated with poor quality of life, high health care costs, and increased risk for adverse outcomes. These patients are often lacking an optimal home care which may result in subsequent readmissions. However, a specific case management programme for elderly patients with myocardial infarction (MI) is not yet available. The objective of this trial is to examine the effectiveness of a nurse-based case management in patients aged 65 years and older discharged after treatment of an acute MI in hospital. The programme is expected to influence patient readmission, mortality and quality of life, and thus to reduce health care costs compared with usual care. In this paper the study protocol is described. METHODS/DESIGN: The KORINNA (Koronarinfarkt Nachbehandlung im Alter) study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg). Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost-effectiveness ratio (ICER) will be calculated. DISCUSSION: The KORINNA study will contribute to the evidence regarding the effectiveness of case management programmes in aged people with MI. The results can be an important basis for clinicians, administrators and health policy makers to decide on the provision of high-quality care to older patients with CHD. TRIAL REGISTRATION: ISRCTN0289374

Effects of a nurse-based case management compared to usual care among aged patients with myocardial infarction: results from the randomized controlled KORINNA study

BACKGROUND: Transition from hospital to home is a critical period for older persons with acute myocardial infarction (AMI). Home-based secondary prevention programs led by nurses have been proposed to facilitate the patients’ adjustment to AMI after discharge. The objective of this study was to evaluate the effects of a nurse-based case management for elderly patients discharged after an AMI from a tertiary care hospital. METHODS: In a single-centre randomized two-armed parallel group trial of patients aged 65 years and older hospitalized with an AMI between September 2008 and May 2010 in the Hospital of Augsburg, Germany, patients were randomly assigned to a case management or a control group receiving usual care. The case-management intervention consisted of a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention were to detect problems or risks and to give advice regarding a wide range of aspects of disease management (e.g. nutrition, medication). Primary study endpoint was time to first unplanned readmission or death. Block randomization per telephone call to a biostatistical center, where the randomization list was kept, was performed. Persons who assessed one-year outcomes and validated readmission data were blinded. Statistical analysis was based on the intention-to-treat approach and included Cox Proportional Hazards models. RESULTS: Three hundred forty patients were allocated to receive case-management (n=168) or usual care (n=172). The analysis is based on 329 patients (intervention group: n=161; control group: n=168). Of these, 62% were men, mean age was 75.4 years, and 47.1% had at least either diabetes or chronic heart failure as a major comorbidity. The mean follow-up time for the intervention group was 273.6 days, and for the control group it was 320.6 days. During one year, in the intervention group there were 57 first unplanned readmissions and 5 deaths, while the control group had 75 first unplanned readmissions and 3 deaths. With respect to the endpoint there was no significant effect of the case management program after one year (Hazard Ratio 1.01, 95% confidence interval 0.72-1.41). This was also the case among subgroups according to sex, diabetes, living alone, and comorbidities. CONCLUSIONS: A nurse-based management among elderly patients with AMI had no significant influence on the rate of first unplanned readmissions or death during a one-year follow-up. A possible long-term influence should be investigated by further studies. CLINICAL TRIAL REGISTRATION: ISRCTN0289374

Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials

Abstract Background Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories. Methods In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance. Results Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%. With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients. Conclusion Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has to be modified because of the increased standard deviation. This approach is suitable to enable economic evaluation with lower costs to both study participants and investigators. Trial registration The trial registration number is ISRCTN02893746</p

Sex differences in patient-reported symptoms associated with myocardial infarction (from the population-based MONICA/KORA myocardial infarction registry)

Many studies have examined gender-related differences in symptoms of acute myocardial infarction (AMI). However, findings have been inconsistent, largely because of different study populations and different methods of symptom assessment and data analysis. This study was based on 568 women and 1,710 men 25 to 74 years old hospitalized with a first-ever AMI from January 2001 through December 2006 recruited from a population-based AMI registry. Occurrence of 13 AMI symptoms was recorded using standardized patient interview. After controlling for age, migration status, body mass index, smoking, some co-morbidities including diabetes, and type and location of AMI through logistic regression modeling, women were significantly more likely to complain of pain in the left shoulder/arm/hand (odds ratio [OR] 1.36, 95% confidence interval [CI] 1.10 to 1.69), pain in the throat/jaw (OR 1.78, 95% CI 1.43 to 2.21), pain in the upper abdomen (OR 1.39, 95% CI 1.02 to 1.91), pain between the shoulder blades (OR 2.22, 95% CI 1.78 to 2.77), vomiting (OR 2.23, 95% CI 1.67 to 2.97), nausea (OR 1.94, 95% CI 1.56 to 2.39), dyspnea (OR 1.45, 95% CI 1.17 to 1.78), fear of death (OR 2.17, 95% CI 1.73 to 2.72), and dizziness (OR 1.49, 95% CI 1.16 to 1.91) than men. Furthermore, women were more likely to report &gt;4 symptoms (OR 2.14, 95% CI 1.72 to 2.66). No significant gender differences were found in chest pain, feelings of pressure or tightness, diaphoresis, pain in the right shoulder/arm/hand, and syncope. In conclusion, women and men did not differ regarding the chief AMI symptoms of chest pain or feelings of tightness or pressure and diaphoresis. However, women were more likely to have additional symptoms

Does nurse-based case management for aged myocardial infarction patients improve risk factors, physical functioning and mental health? The KORINNA trial

BACKGROUND: Older patients with acute myocardial infarction (MI) are often lacking optimal support to continue rehabilitation after discharge from hospital. The objective of the study was to examine whether a home-based case management programme led by nurses can improve atherogenic risk factors, physical functioning, and mental health in the first year following discharge. METHODS: The KORINNA study is a randomized two-armed parallel group trial including 329 patients (aged 65-92 years) from the Augsburg Hospital in southern Germany. The intervention consisted of an individualized follow-up programme with a duration of 1 year, including home visits and telephone calls. The control group received usual care. Secondary outcome measures included clinical parameters (blood pressure, lipid parameters), functional status measures, cognitive status, depressive symptoms, and nutrition risk. RESULTS: At 1-year follow up, patients in the intervention group (n&thinsp;=&thinsp;116) had significantly better low-density lipoprotein cholesterol levels (-8.4&thinsp;mg/dl, 95% CI -16.4 to -0.4), hand grip strength (+2.53&thinsp;kg, 95% CI 0.56 to 4.50), and SCREEN-II nutrition risk scores (+2.03, 95% CI 0.58 to 3.48) than patients in the control group (n&thinsp;=&thinsp;136). The intervention group also had better mean scores with regard to self-reported disability, activities in daily living, and mental health, but differences were not always significant and meaningful. CONCLUSIONS: The results of the KORINNA study indicate that nurse-based case management can improve blood lipid levels, functional status, and nutrition risk of aged patients with MI. &nbsp

Prognosis and outcomes of elderly (75–84 years) patients with acute myocardial infarction 1–2 years after the event: AMI-elderly study of the MONICA/KORA myocardial infarction registry

BACKGROUND: With increasing life expectancy the management of acute myocardial infarction (AMI) in patients of an older age is of growing importance. However, long-term data are limited regarding &#39;hard&#39; endpoints and quality of life in unselected elderly patients in &#39;real world&#39; settings. METHODS AND RESULTS: From March 2005 to March 2006 all 75-84-year old patients consecutively hospitalised due to an incident AMI in a large community teaching hospital were analyzed (N=235). Evidence-based therapy included the treatment with aspirin (93%), clopidogrel (65%), betablockers (93%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (84%), and statins (83%). Percutaneous coronary intervention (PCI) was performed in 45.5% and bypass grafting (CABG) in 10.2%. The 28-day-case fatality was 17.4%. Long-term follow-up was obtained in 95.9% of all hospital survivors at a mean of 18.7 &plusmn; 6.4 months; during this time 19.9% of patients died. After multivariate analysis the only significantly negative predictor for survival and MACCE was diabetes, and the only significantly positive predictor was revascularisation during hospital stay. Patients with PCI/CABG had lower NYHA class (81% vs. 48%; p&lt;0.04). Patients with PCI also had a higher EQ-5D index score (75 &plusmn; 18 vs. 67 &plusmn; 17, p&lt;0.04) compared to patients not receiving PCI. CONCLUSION: The positive long-time effect of revascularisation procedures during hospitalisation, not only on &#39;hard&#39; endpoints but also on functional outcome and quality of life emphasizes that invasive therapies should not be considered less valuable in elderly people and that age alone should not preclude aggressive treatment during AMI