Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer.

PURPOSE: Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer. METHODS: Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups. RESULTS: The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044). CONCLUSION: Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.

Characteristics and patient-reported outcomes associated with dropout in severely affected oncological patients: an exploratory study.

BACKGROUND: Patient-reported outcome measures (PROMs) are commonly-used surrogates for clinical outcomes in cancer research. When researching severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-outs or missing data from patients who pass away during the observation period. The aim of this exploratory study was to explore patient characteristics and the patient-reported outcomes associated with the time-to-dropout. METHODS: In an Oncological Social Care Project (OSCAR) study, the condition of the participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risk regressions based on Fine and Gray's proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered a competing risk. RESULTS: Three hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed a follow-up after 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to a higher risk of drop-out (SHR = 2.10; 95%CI: 1.01-4.35). Lower values in health-related quality of life were related to drop-out and death. The sub-scales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics of early drop-out. CONCLUSION: Severely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies than patients with higher levels of social support and a better quality of life. This should be considered when planning studies to assess advanced cancer patients. Methods of close continued monitoring should be actively used when patient experiences a substantial deterioration in their health-related quality of life and symptoms during the study. Results for such studies have to be interpreted with caution in light of specific drop-out mechanisms. TRIAL REGISTRATION: OSCAR study was registered to the German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017.

Improving quality of life in cancer patients through higher participation and health literacy: study protocol for evaluating the oncological social care project (OSCAR).

BACKGROUND: Cancer patients experience psychological and social distress due to their medical treatment and social issues. However, continuous and specialized social support is still lacking. In Germany, a group of company health insurance funds has developed an approach to support cancer patients with monthly structured interviews conducted by specially trained Social Care Nurses. The nurses will identify patient needs in order to provide help with medical, personal, and social matters. One aim of the scientific evaluation is to analyze the effect of the consultations on various patient-reported outcomes, especially quality of life. The evaluation concept will be described in this study protocol. METHODS/DESIGN: The evaluation is a non-randomized, controlled, multi-center intervention study with a mixed-method design. It consists of three research modules which include primary data from questionnaires, and claims data from the health insurance funds. In Module 1, cancer patients will be recruited to form an intervention group (OSCAR, n = 150) and a control group (n = 200) in four study centers for a period of 1 year. One baseline and three follow-up questionnaires will be conducted to survey the patient-reported outcomes. Relevant secondary outcomes are health literacy, participation, and physician-patient communication. In Module 2, claims data will be used to analyze cost effects and thereby assess effectivity and hospitalization. Module 3 will involve a qualitative analysis of project diaries kept by the Social Care Nurses. The diaries will record the nurses' practical experiences and the benefits of deploying OSCAR across the German healthcare system. DISCUSSION: OSCAR is an innovative way of providing cancer patients with continuous support to improve their quality of life. The evaluation concept aims to assess the effects of the monthly consultations by the Social Care Nurses on the patients, and will use a mixed-method design. The results are important for assessing the transferability of OSCAR to the healthcare system as a whole. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017.

[Quality of German-Language Guidelines for Post-Stroke Rehabilitation of Aphasia and Dysarthria - Results of a Systematic Review and of an International Comparison]. / Deutschsprachige Leitlinien für die Aphasie- und Dysarthriebehandlung nach Schlaganfall.

AIM: Evaluation of German-language guidelines for aphasia and dysarthria rehabilitation, and comparison with international guidelines. METHODS: The quality of the 6 included guidelines, as found through a comprehensive literature search, was sytematically evaluated using AGREE II. Quality ratings were compared to the results of a systematic review of 19 English-language guidelines. RESULTS: The quality of German-language guidelines was heterogeneous. In 2 out of 6 evaluation domains and in the overall assessment, no German-language guideline reached the cut-off of 66,67% for good guideline quality. Apart from the domain Editorial Independence, results remained behind those of the international reference guidelines. CONCLUSION: In some cases, quality can be improved by simple means. It is more resource-intensive, but crucial to document search strategies and how evidence was used in guideline development. A harmonization of the German-language guidelines seems desirable.

Analytical and Clinical Validation of a Point-of-Care Cardiac Troponin T Test with an Improved Detection Limit.

BACKGROUND: The point-of-care test Roche CARDIAC POC Troponin T (PoC TnT) is an improved assay which has been developed for the Roche cobas h 232 system. METHODS: We performed a multicentre evaluation (four sites) to assess the analytical performance of the PoC TnT assay and to compare it with the central laboratory Elecsys® troponin T high sensitive (lab cTnT-hs) assay. RESULTS: The relative mean differences found in method comparisons of PoC TnT vs. lab cTnT-hs ranged from -4.1% to +6.8%. Additionally, there was good concordance between PoC TnT and lab cTnT-hs for the number of samples with troponin T values below the measuring range of 40 ng/L. Lot-to-lot differences of PoC TnT ranged from -8.6% to +4.6%. Within-series coefficients of variation (CV) resulting from 81 ten-fold measurements with patient samples were 9.3%, 11.8%, and 12.9% in the low (40 to < 200 ng/L), medium (200 to < 600 ng/L), and high (600 to 2000 ng/L) measuring range, respectively. Using the system quality control, the mean CV for between-day imprecision was 11.3%. No interference was observed by triglycerides (up to 11.4 mmol/L), bilirubin (up to 376 µmol/L), hemoglobin (up to 0.12 mmol/L), biotin (up to 30 µg/L), rheumatoid factor (up to 200 IU/mL), or with 52 standard or cardiovascular drugs at therapeutic concentrations. There was no influence on the results by varying hematocrit values in a range from 25% to 53%. However, interferences with human anti-mouse antibodies were found. No significant influence on the results was found with PoC TnT by using sample volumes between 135 to 165 µL. High troponin T concentrations up to 500 µg/L did not lead to false low results, indicating no high-concentration hook effect. No cross-reactivity was found between the PoC TnT assay and human skeletal troponin T up to 1000 µg/L (< 0.05%). Diagnostic sensitivity and specificity data of a subpopulation (23 patients) of this study are in agreement with results of another large pre-hospital study. CONCLUSIONS: The PoC TnT assay showed good analytical performance with excellent concordance with the calibration and reference laboratory method. It should therefore be suitable for its intended use in point-of-care settings.

Associations among navigational support and health care utilization and costs in patients with advanced cancer: An analysis based on administrative health insurance data.

BACKGROUND: Fragmented and complex healthcare systems make it difficult to provide continuity of care for patients with advanced cancer near the end of life. Nurse-based cross-sectoral navigation support has the potential to increase patients' quality of life. The objective of this paper was to evaluate associations between navigation support and health care utilization, and the associated costs of care. METHODS: The evaluation is based on claims data from 37 statutory health insurance funds. Non-randomized recruitment of the intervention group (IG) took place between 2018 and 2019 in four German hospitals. The comparison group (CG) was defined ex post. It comprises nonparticipating clients of the involved health insurance funds matched on age, gender, and diagnosis in a 1:4 ratio to the IG. Healthcare resource utilization was compared using incident rate ratios (IRRs) based on negative binomial regression models. Linear mixed models were performed to compare differences in lengths of hospital stays and costs between groups. RESULTS: A total of 717 patients were included (IG: 149, CG: 568). IG patients showed shorter average lengths of hospital stays (IG: 11 days [95% CI: 10, 13] vs. CG: 15 days [95% CI: 14, 16], p < 0.001). In the IG, 21% fewer medications were prescribed and there were on average 15% fewer outpatient doctor contacts per month. Average billed costs in the IG were 23% lower than in the CG (IG: 6754 EUR [95% CI: 5702, 8000] vs. CG: 8816 EUR [95% CI: 8153, 9533], p < 0.001). CONCLUSIONS: The intervention was associated with decreased costs mainly as a result of a non-intended navigation effect. The social care nurses had navigated patients within the hospital early, needs-oriented and effectively but interpreted their function less cross-sectorally. Linkage of hospital-based navigators with the outpatient care sector needs further exploration.

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.

Suitability of the German version of the Manchester Triage System to redirect emergency department patients to general practitioner care: a prospective cohort study.

OBJECTIVES: To investigate the suitability of the German version of the Manchester Triage System (MTS) as a potential tool to redirect emergency department (ED) patients to general practitioner care. Such tools are currently being discussed in the context of reorganisation of emergency care in Germany. DESIGN: Prospective cohort study. SETTING: Single centre University Hospital Emergency Department. PARTICIPANTS: Adult, non-surgical ED patients. EXPOSURE: A non-urgent triage category was defined as a green or blue triage category according to the German version of the MTS. PRIMARY AND SECONDARY OUTCOME MEASURES: Surrogate parameters for short-term risk (admission rate, diagnoses, length of hospital stay, admission to the intensive care unit, in-hospital and 30-day mortality) and long-term risk (1-year mortality). RESULTS: A total of 1122 people presenting to the ED participated in the study. Of these, 31.9% (n=358) received a non-urgent triage category and 68.1% (n=764) were urgent. Compared with non-urgent ED presentations, those with an urgent triage category were older (median age 60 vs 56 years, p=0.001), were more likely to require hospital admission (47.8% vs 29.6%) and had higher in-hospital mortality (1.6% vs 0.8%). There was no significant difference observed between non-urgent and urgent triage categories for 30-day mortality (1.2% [n=4] vs 2.2% [n=15]; p=0.285) or for 1-year mortality (7.9% [n=26] vs 10.5% [n=72]; p=0.190). Urgency was not a significant predictor of 1-year mortality in univariate (HR=1.35; 95% CI 0.87 to 2.12; p=0.185) and multivariate regression analyses (HR=1.20; 95% CI 0.77 to 1.89; p=0.420). CONCLUSIONS: The results of this study suggest the German MTS is unsuitable to safely identify patients for redirection to non-ED based GP care. TRIAL REGISTRATION NUMBER: U1111-1119-7564; Post-results.

Suitability of current definitions of ambulatory care sensitive conditions for research in emergency department patients: a secondary health data analysis.

OBJECTIVE: The aim of this study was to investigate the suitability of existing definitions of ambulatory care sensitive conditions (ACSC) in the setting of an emergency department (ED) by assessing ACSC prevalence in patients admitted to hospital after their ED stay. The secondary aim was to identify ACSC suitable for specific application in the ED setting. DESIGN: Observational clinical study with secondary health data. SETTING: Two EDs of the Charité-Universitätsmedizin Berlin. PARTICIPANTS: All medical ED patients of the 'The Charité Emergency Medicine Study' (CHARITEM) study, who were admitted as inpatients during the 1-year study period (n=13 536). OUTCOME MEASURES: Prevalence of ACSC. RESULTS: Prevalence of ACSC in the study population differed significantly depending on the respective ACSC set used. Prevalence ranged between 19.1% (95% CI 18.4% to 19.8%; n=2586) using the definition by Albrecht et al and 36.6% (95% CI 35.8% to 37.5%; n=4960) using the definition of Naumann et al. (p<0.001). Overall ACSC prevalence (ie, when using all diagnoses used in any of the assessed ACSC-definitions) was 48.1% (95% CI 47.2% to 48.9%; n=6505). Some frequently observed diagnoses such as 'convulsion and epilepsy' (prevalence: 3.4%, 95% CI 3.1% to 3.7%; n=455), 'diseases of the urinary system' (prevalence: 1.4%; 95% CI 1.2% to 1.6%; n=191) or 'atrial fibrillation and flutter' (prevalence: 1.0%, 95% CI 0.8% to 1.2%, n=134) are not included in all of the current ACSC definitions. CONCLUSIONS: The results highlight the need for an optimised, ED-specific ACSC definition. Particular ACSC diagnoses (such as 'convulsion and epilepsy' or 'diseases of the urinary system' and others) seem to be of special relevance in an ED population but are not included in all available ACSC definitions. Further research towards the development of a suitable and specific ACSC definition for research in the ED setting seems warranted. TRIAL REGISTRATION: German Clinical Trials Register Deutsches Register für Klinische Studien: DRKS-ID: DRKS00000261.

[Perception of the Emergency Department for Outpatient Care in a Rural Region in Saxony-Anhalt: A Qualitative Survey of Patients and General Practitioners]. / Bedeutung der Notaufnahme für die ambulante medizinische Versorgung in einer ruralen Region in Sachsen-Anhalt: Qualitative Befragung von Patienten und Hausärzten.

Background The increasing number of low-acuity visits to Emergency Departments (ED) is an important issue in Germany and contributes to ED crowding. A sustainable solution needs deeper knowledge of patients' underlying rationales. Methods To explore patients' motives we conducted 31 semi-structured face-to-face interviews with low-acuity ED patients in a rural region in Saxony-Anhalt. Subsequently we interviewed 12 General Practitioners (GP)s about their perspectives on patients visiting ED with low-acuity conditions and referring patients to ED. A qualitative content analysis approach was used for data analysis. Results All patients were connected to a GP. One third had visited ED because of 24/7 availability when consultation hours and working times overlapped. Another third had addressed EDs full range of laboratory and imaging technology with a subjective need for fast diagnosis. One group reported that they had been referred to the ED by their GP. The interviewed GPs classified patients' ED usage for time-constraints as impatience and growing demand, while they expressed greater understanding for patients striving to ED for anxiety reasons. Most GPs sometimes referred patients to ED for diagnostic reasons. Conclusion The findings demonstrate that ED usage with non-urgent conditions takes place for different reasons. Therefore, ED plays a pivotal role not only in emergency care, but also in ambulant care. The growing demand for ambulant care indicates a need for changed health care structures.

Acute heart failure facts and numbers: acute heart failure populations.

Acute heart failure (AHF) is a life-threatening emergency, which largely profits from early diagnosis and treatment. The prevalence of AHF is difficult to assess, estimates range between 1 and 12% in the general population. Despite recent therapeutic advances, in-hospital mortality is high with estimates varying from 4 and 18% in different registries. Due to large differences in AHF definitions and selection criteria AHF populations vary in their characteristics and outcomes. This is especially true for randomized clinical trials and the external validity of some of these trials is questionable. Additionally, the timing of data collection and/or initiation of new therapies vary with the setting of trials. The aim of this article is to call attention to the difference in AHF populations and to emphasize the need for research to clearly define these populations. AHF populations from registries and clinical trials are the basis for evidence-based management strategies. It is important that these populations represent the patients in whom these strategies will be applied in routine care.

Patient motives behind low-acuity visits to the emergency department in Germany: a qualitative study comparing urban and rural sites.

OBJECTIVES: The increasing number of low-acuity visits to emergency departments (ED) is an important issue in Germany, despite the fact that all costs of inpatient and outpatient treatment are covered by mandatory health insurance. We aimed to explore the motives of patients categorised with low-acuity conditions for visiting an ED. METHODS: We conducted a qualitative study in two urban and one rural ED. We recruited a purposive sample of adults, who were assigned to the lowest two categories in the Manchester triage system. One-to-one interviews took place in the ED during patients' waiting time for treatment. Interview transcripts were analysed using the qualitative data management software MAXQDA. A qualitative content analysis approach was taken to identify motives and to compare the rural with the urban sites. RESULTS: A total of 86 patients were asked to participate; of these, n=15 declined participation and n=7 were excluded because they were admitted as inpatients, leaving a final sample of 40 female and 24 male patients. We identified three pathways leading to an ED visit: (1) without primary care contact, (2) after unsuccessful attempts to see a resident specialist or general practitioner (GP) and (3) recommendation to visit the ED by an outpatient provider. The two essential motives were (1) convenience and (2) health anxiety, triggered by time constraints and focused usage of multidisciplinary medical care in a highly equipped setting. All participants from the rural region were connected to a GP, whom they saw more or less regularly, while more interviewees from the urban site did not have a permanent GP. Still, motives to visit the ED were in general the same. CONCLUSIONS: We conclude that the ED plays a pivotal role in ambulatory acute care which needs to be recognised for adequate resource allocation. TRIAL REGISTRATION NUMBER: DRK S00006053.

Incidence, prevalence and 1-year all-cause mortality of heart failure in Germany: a study based on electronic healthcare data of more than six million persons.

AIMS: Heart failure (HF) continues to be a leading cause of morbidity and mortality in industrialized countries. Data on the epidemiology of HF are largely lacking for Germany. The aims of this study were to estimate the incidence and prevalence of HF in Germany, to estimate 1-year all-cause mortality in patients who received their first diagnosis of HF in hospital and to assess related risk factors. METHODS: The study was based on data for the years 2004-2006 from three German statutory health insurance providers, comprising data of more than six million people. The study sample was not restricted to a specific age group. The incidence rate of HF in 2006 was assessed in patients who did not have a diagnosis of HF or had not received medications for HF in the previous 2 years. One-year all-cause mortality in patients who received their first diagnosis of HF in hospital was analysed using Kaplan-Meier method and Cox proportional hazard model. Case identification was based on confirmed outpatient diagnoses, main and secondary hospital discharge diagnoses as well as medications for HF. RESULTS: The age- and sex-standardized incidence rate of HF was 2.7 per 1000 person years. Age- and sex-standardized prevalence of HF was 1.7% in 2004, 1.9% in 2005 and 1.7% in 2006. The 1-year all-cause mortality was 23% among patients who received their first HF diagnosis during a hospitalization in 2006. CONCLUSION: Our study revealed an incidence and prevalence of HF in Germany which were largely comparable to those from other countries. Due to the poor prognosis of HF, high readmission rates and an aging society, HF remains highly relevant in the context of health care planning.