Primary and secondary data in emergency medicine health services research - a comparative analysis in a regional research network on multimorbid patients.

BACKGROUND: This analysis addresses the characteristics of two emergency department (ED) patient populations defined by three model diseases (hip fractures, respiratory, and cardiac symptoms) making use of survey (primary) and routine (secondary) data from hospital information systems (HIS). Our aims were to identify potential systematic inconsistencies between both data samples and implications of their use for future ED-based health services research. METHODS: The research network EMANET prospectively collected primary data (n=1442) from 2017-2019 and routine data from 2016 (n=9329) of eight EDs in a major German city. Patient populations were characterized using socio-structural (age, gender) and health- and care-related variables (triage, transport to ED, case and discharge type, multi-morbidity). Statistical comparisons between descriptive results of primary and secondary data samples for each variable were conducted using binomial test, chi-square goodness-of-fit test, or one-sample t-test according to scale level. RESULTS: Differences in distributions of patient characteristics were found in nearly all variables in all three disease populations, especially with regard to transport to ED, discharge type and prevalence of multi-morbidity. Recruitment conditions (e.g., patient non-response), project-specific inclusion criteria (e.g., age and case type restrictions) as well as documentation routines and practices of data production (e.g., coding of diagnoses) affected the composition of primary patient samples. Time restrictions of recruitment procedures did not generate meaningful differences regarding the distribution of characteristics in primary and secondary data samples. CONCLUSIONS: Primary and secondary data types maintain their advantages and shortcomings in the context of emergency medicine health services research. However, differences in the distribution of selected variables are rather small. The identification and classification of these effects for data interpretation as well as the establishment of monitoring systems in the data collection process are pivotal. TRIAL REGISTRATION: DRKS00011930 (EMACROSS), DRKS00014273 (EMAAGE), NCT03188861 (EMASPOT).

The Abdominal Pain Unit (APU). Study protocol of a standardized and structured care pathway for patients with atraumatic abdominal pain in the emergency department: A stepped wedged cluster randomized controlled trial.

This study aims to improve emergency department (ED) care for patients suffering from atraumatic abdominal pain. An application-supported pathway for the ED will be implemented, which supports quick, evidence-based, and standardized diagnosis and treatment steps for patients with atraumatic abdominal pain at the ED. A mixed-methods multicentre cluster randomized controlled stepped wedge trial design will be applied. A total of 10 hospitals with EDs (expected n = 2.000 atraumatic abdominal pain patients) will consecutively (every 4 months) be randomized to apply the intervention. Inclusion criteria for patients are a minimum age of 18 years, suffering from atraumatic abdominal pain and being insured with a German statutory health insurance. Primary outcomes: acute pain score at time of discharge from ED, duration of treatment at the ED, patient-reported satisfaction. Secondary endpoints include patient safety and quality of care parameters, process evaluation parameters, and costs and cost-effectiveness parameters. Quantitative data will be gathered from patient-surveys, clinical records, and routine data from hospital information systems as well as from a participating German statutory health insurance. Descriptive and analytic statistical analysis will be performed to provide summaries and associations for primary patient-reported outcomes, process measures, quality measures, and costs. Qualitative data collection consists of participatory patient observations and semi-structured expert interviews, which will be inductively analysed. Findings will be disseminated in publications in peer-reviewed journals, on conferences, as well as via a project website. To ensure data protection, appropriate technical and organisational measures will be taken. Trial registration: DRKS00021052.

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial.

BACKGROUND: Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. METHODS AND RESULTS: A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to € 14,412 (95% CI 13,284-15,539) in the RPM group and € 17,537 (95% CI 16,179-18,894) in the UC group. RPM led to cost savings of € 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of € 1758 per patient year remained (p = 0.048). CONCLUSION: The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness.

Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial.

INTRODUCTION: Guidelines recommend lifestyle intervention in chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). However, evidence from randomised controlled trials is scarce in patients with combined entities. METHODS AND ANALYSIS: The Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (LeIKD) trial is a prospective, multicentre study that will randomise (1:1) patients with CIHD (ICD-10: I20-I25) and T2DM (ICD-10: E11) from one health insurance company into a lifestyle intervention (LS) or usual care (UC). Active LS consists of an individual combined exercise programme of strength and endurance training and nutritional counselling with regular feedback for 6 months. Intervention is supported by telemedicine. Follow-up without individualised feedback will continue for 6 months. The study aims to investigate whether an individualised telemedical supported LS intervention is superior to UC in improving cardiovascular risk factors, physical activity, quality of life, health literacy, major cardiovascular events and health economics in patients with both CIHD and T2DM. Primary endpoint is the change in HbA1c from baseline to 6 months. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Technical University of Munich (registration number: 144/18-S) and at each study site. The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. It is funded by the Federal Joint Committee (www.innovationsfonds.g-ba.de), reference number 01NVF17015, which has no impact on data collection, analysis or interpretation. Dissemination is independent of the funding source. TRIAL REGISTRATION NUMBER: Clinical trials.gov identifier: NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.