Original article
Evaluation of an Automated Decision Aid for the Further Referral of Emergency Room Patients
A prospective cohort study
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Background: Instruments for the initial evaluation of emergency room patients as an aid to their onward referral to ambulatory care structures are a matter of current interest. In this study, we assess the safety of the software application SmED-Kontakt+ for this purpose. SmED is an abbreviation for Strukuturierte Medizinische Ersteinschätzung Deutschland, “structured initial medical evaluation in Germany.”
Methods: In this prospective cohort study, we compared the recommendations of SmED-Kontakt+ concerning the time and place of further care with those of the treating physicians. The subjects were adult patients who were able to walk and had presented themselves to the emergency room. Whenever SmED-Kontakt+ assessed the situation less critically than the physicians, and in 5% of the remaining cases, the potential endangerment of patient safety was assessed by an expert panel (expected value <1%).
Results: In a total of 1840 cases, SmED-Kontakt+ agreed with the physicians’ assessment in 353 (19%). The assessment of SmED-Kontakt+ was more critical in 1221 cases (66%) and less critical in 266 (15%; potential undertriage). There was potential endangerment in 49 cases (2.7%; 95% confidence interval [2.0; 3.5]). Potential endangerment was less common among patients in the more urgent recommendation categories [0.1; 2.6] and more common in the categories of a recommended outpatient physician visit or telephone consultation within or beyond 24 hours [2.4; 17.2].
Conclusion: SmED-Kontakt+ generally assessed these patients’ needs for further care as more urgent than the treating physicians did. Nevertheless, the percentage of potentially endangered patients was higher than expected. We conclude that further care should be provided in timely fashion with an obligatory appointment. The sites of further ambulatory care should be immediately accessible and properly equipped. Patients should not be referred for further care at later times on the basis of an SmED-Kontakt+ assessment.
The redirection of emergency room patients to ambulatory care facilities is the subject of an ongoing healthcare debate and is included in various committee recommendations, such as that of the Federal Joint Committee (G-BA) (1, 2, 3, 4).
The well-established five-level triage systems used in emergency rooms specify when treatment of patients should begin (from immediately to within 120 minutes) (5). However, these triage systems are not suitable for giving recommendations for later care planning and alternative places of further care, such as out-of-hours medical services. Requirements for an initial assessment tool to redirect patients from emergency departments have been defined in the G-BA’s initial assessment guideline, which has yet to come into effect (1). Such an instrument, known as “Structured Initial Medical Evaluation in Germany” (SmED), is already being used by the call centers of the Associations of Statutory Health Insurance Physicians (KV) to redirect medical emergencies.
SmED is a web-based medical assessment system which is designed to enable a quick and reliable assessment of time and place of further care by trained non-physician health professionals using a structured questionnaire of symptoms, previous illnesses, and other relevant information. This is achieved either by telephone in the call centers of the Association of Statutory Health Insurance Physicians (KV) (SmED) or directly on site in emergency rooms or at out-of-hours medical services (SmED-Kontakt+). Based on patients’ answers, SmED generates a recommendation for time and place of further care. The DEMAND study compared mortality rates with assessment numbers of SmED in emergency rooms and KV call centers and found no increased mortality rates from this aggregated analysis (6). However, the term “patient safety” also encompasses the occurrence of serious adverse events and thus goes beyond the mere analysis of mortality (7, 8).
The primary aim of the present study was to evaluate the safety of SmED-Kontakt+ recommendations with respect to time and place of the further care of adult walk-in emergency room patients.
Methods
Study design and setting
A prospective cohort study was conducted at two emergency rooms, one at the Charité—Universitätsmedizin Berlin and the other at the Central Emergency Department of the University of Leipzig Medical Center. It included adult patients who had presented themselves on their own accord (walk-in, no referral) and with whom an SmED-Kontakt+ assessment was possible (sufficient language skills [German, English], cognition, and verbal communication). Recruitment was conducted from February 7 to December 31, 2022, Monday to Sunday, 10 a.m. to 6 p.m. During the study period, the emergency rooms recorded a total number of 90 875 cases, of which 60 996 were outpatient cases.
Selection of study participants and study process
The participating patients were recruited after emergency room triage and prior to start of treatment. Patient symptoms were assessed in a structured manner by trained study personnel using the SmED-Kontakt+ assessment questionnaire (SmED-Version 7.1).
SmED-Kontakt+ provides a recommendation for the time of further care using the following categories:
- emergency (immediately)
- as soon as possible
- within 24 hours
- more than 24 hours.
The recommendation for the place of further care (care level) is provided using the categories:
- emergency services
- emergency room
- statutory health insurance (SHI) physician
- teleconsultation.
For the purposes of the present study, the categories “emergency services” and “emergency room” were combined under “emergency room”.
Patients were then treated routinely in the emergency room. The clinical staff were blinded to the SmED-Kontakt+ recommendation. After initial patient contact, the treating physicians (assigned residents and specialists) made an assessment of the following parameters using a standardized evaluation form (eSupplement Figure 1):
- resources likely to be required (for example, ultrasound, X-ray)
- patient mobility and general condition
- time of further care and care level.
Primary study objective
The primary aim of the study was to evaluate SmED-Kontakt+ with respect to patient safety in the emergency room. The primary endpoint was to determine the proportion of potentially dangerous false-low recommendations by SmED-Kontakt+ among all the cases included in the study. A potentially false-low recommendation was considered present if SmED-Kontakt+ rated a patient as less urgent than otherwise required according to expert opinion, and this would have potentially resulted in a risk to patient safety.
Evaluation of the primary endpoint
The primary endpoint was assessed by specialist experts from the private practice sector and emergency rooms. They looked at all cases which had been assessed by SmED-Kontakt+ as less urgent than by the treating emergency room physicians. In addition, they also assessed a random sample of five percent of the other cases (Supplement Figure 2).
The initial assessment was conducted with knowledge of all medical information available at the time of admission, including medical history (T0 = primary endpoint), and afterwards with knowledge of the overall medical course (T1 = secondary endpoint).
The definition of potential risk corresponded to the definition in the ICH guideline on Good Clinical Practice (8) and included the following situations:
- a potentially fatal or life-threatening outcome
- a potentially persistent or significant disability or incapacity
- a potentially manifest clinical deterioration.
The specialist experts had appropriate experience in emergency care. Each case was initially assessed in writing by two experts (in equal numbers from the private practice sector and emergency room). If their assessment was the same with respect to the primary endpoint the case was considered conclusive. If the written assessment revealed a discrepancy, then the case was further assessed by a panel of experts (n=4) with an independent moderator (also in equal numbers from the private sector and emergency room).
After a brief presentation of the case, an independent written assessment of patient risk was made. If the experts’ written assessments differed, an independently moderated discussion was held for the primary endpoint in order to reach a consensus. Only a written assessment was recorded for the secondary endpoints.
Data entry
Data were recorded in RedCap (Research Electronic Data Capture) using study-specific electronic data entry forms (9). The reasons for patients’ presenting in the emergency room were coded using the German version of the Canadian Emergency Department Information System chief complaint documentation list (CEDIS) (10).
Statistical analysis
The working hypothesis was: Potentially dangerous undertriage is not present if the upper limit of the binomial Clopper-Pearson 95% confidence interval does not exceed the one percent limit (11). A total of 2000 cases was required to test this hypothesis. The description of the study population and analysis of secondary endpoints were performed exploratively using descriptive statistics in SPSS Version 29.
Regulatory aspects
The study was assessed and approved by the responsible ethics commissions and data protection officers in Berlin (EA2/124/21; data protection Nr. 511) and Leipzig (489/21). It is registered with the German Clinical Trials Registry (DRKS-ID DRKS00026988). SmED is a Class IIB medical product which is certified according to the medical product guideline (MDR) (manufacturer: in4medicine AG, Bern, Switzerland; importer: Health Care Quality Systems (HCQS), Göttingen, Germany).
Results
A total of 2571 patients were screened and 2181 were included in the study. Complete data were available for 1840 patients (Figure 1). Median age was 35 years, 51.1% of participants were women, 48.7% men, and 0.2% non-binary (eSupplement-Table 1). SmED-Kontakt+ was easy to use, and the estimated median assessment time was two to three minutes.
SmED-Kontakt+ recommendations and agreement with the recommendations of the treating physicians
SmED-Kontakt+ recommended immediate or fastest possible care in the emergency room for 63.2% of cases (n = 1162) and fastest possible ambulatory care by an SHI physician in 10.7% (n = 196). SHI medical care/teleconsultation within 24 hours (19.4%; n = 357) or after 24 hours (6.8%; n = 125) was recommended less often (eSupplement Table 2). The SmED-Kontakt+ recommendation was more urgent in 66.4% of cases (n = 1221), equally urgent in 19.2% (n = 353), and less urgent in 14.5% than that of the treating physicians (n = 266) (Figure 2, eSupplement eFigures 1 and 2). The main reasons given by the physicians for the need of medical care in the emergency room were: need of available medical resources (56.4%, n = 150), time of further care (28.9%; n = 77), general condition of the patients (6.4%; n = 17), limited mobility (4.5%: n = 12), and other reasons (7.5%; n = 20).
Potential risk to patient safety
The primary endpoint was assessed in writing by experts in 347 cases (18.9%). The assessment resulted in no potential risk in 75.5% of cases (n = 262), with discrepancy in 22.2% (n = 77). Two point three percent of cases assessed in writing were judged unanimously by both experts as potentially at risk (n = 8). Assessment of the discrepant cases (n = 77) at case conferences revealed potential risk to patient safety for a further 41 cases. The primary endpoint was therefore 2.7% overall (95% confidence interval: [2.0; 3.5]; n = 49) (Figure 2). One of the cases potentially at risk was from the random sample (Table 1, Figure 2, Row 2, middle and right box). This corresponds to 1.2% of the sample. Extrapolation to all cases of these categories would produce 19 more cases potentially at risk in these categories. Overall, this could result in a proportion of 3.7% (n = 68) cases at risk in the total population.
A potential risk with knowledge of the overall clinical course (T1) was present in 2.2% of cases (n = 41). A high proportion of cases potentially at risk was evident in the recommendation categories suggesting time of further care up to, and after, 24 hours under SHI care or teleconsultation [7.0; 17.2%] (Table 2).
Clinical characteristics of cases potentially at risk
Based on the Canadian Emergency Department Information System (CEDIS), the reasons for presenting to the emergency room of cases potentially at risk were: orthopedic complaints (26.5% [n = 13]), neurologic complaints (16.3% [n = 8]), skin diseases (12.2 % [n = 6]), gastrointestinal complaints (10.2% [n = 5]), general complaints (8.2% [n = 4]), and trauma (6.1% [n = 3]) (eTable). Further clinical characteristics are presented in Table 1.
Discussion
SmED-Kontakt+ allows a digitally supported initial assessment at the “joint counter” in integrated emergency centers (INZ) where it can be used quickly and reliably. The “joint counter”, or gemeinsamer Tresen in German, is the joint central contact point for both the outpatient emergency care service and the hospital emergency room. In the present study, patient safety when using SmED Kontakt+ in the emergency room was assessed prospectively for the first time and then subjected to an elaborate examination process. With 2.7% and 3.5% as the upper limit of the 95% confidence interval, the potential risk to patient safety was above the expected safety limit of less than one percent. A higher proportion of cases potentially at risk was evident in the recommendation categories “SHI physician or teleconsultation up to 24 hours” (2–7%) and “more than 24 hours” (13–17%). Patients with orthopedic/trauma and neurologic symptoms stood out amongst cases potentially at risk.
Efficiency of redirection
In 63% of the study population, SmED-Kontakt+ recommended care in the emergency room (corresponding to 37% onward referral potential to primary care). The present study population made up a maximum of 40 to 50% of the total population of a university emergency room, giving a hypothetical onward referral potential of around 15% (calculation: 0.37×0.4×100 = 14.8%) (12). This estimation is highly consistent with other studies: One conducted in Frankfurt Höchst demonstrated a decrease in outpatient case numbers as a result of patient redirection of around 33% (around 16% of all emergency admissions) (13). An integrated emergency center pilot project at the Marienfelde Hospital in Hamburg resulted in a reduction potential of 19% by a KV practice (14). At the Rosenheim site, around 14% of patients from emergency departments were treated by SHI physicians, 10% of whom were sent back to the emergency department, however, due to a lack of resources (15). The follow-up study in Rosenheim showed that 49% of patients who presented on their own accord were able to receive definitive treatment from an SHI physician (referral potential around 22%). The piloting of a walk-in clinic outside normal office hours next to an emergency admission center in Hamburg-Eppendorf showed that 33% of all referred cases received definitive treatment (around 15% redirection potential) (16).
In the present study, the vast majority of cases which could have potentially been referred to SHI care were in fact recommended fastest possible care, which would have required immediate access to SHI facilities. Redirection to SHI facilities after more than 24 hours was recommended in only 6.8% of cases (around 3% of the cases of an emergency room population), which is negligible in terms of efficiency and resources (specialist triage, appointment scheduling) but a risk to patient safety (13–17%). The feasibility study from Rosenheim (0.7%) (17) and the Berlin DispoAkut project (2–3%) (18, 19) still confirm a small proportion of patients who could indeed be treated after more than 24 hours.
Safety of redirection
There is currently an evidence gap for Germany with regard to patient safety when using SmED-Kontakt+ or similar instruments for redirection: Only 60% of 93 surveyed emergency rooms cooperating with an alternative health care facility provided information on their redirection mechanism, which was not standardized in 57%; in the 43% with standardized further referral, this was often based on the well-established triage system in the emergency room (71%) (20). Both approaches are not evidence-based (21).
It may be assumed that redirection based on SmED-Kontakt+ with standardized checking for red flags and symptoms has a higher level of safety than those other methods. The DEMAND study showed that redirection using SmED has no impact on mortality rates (6). A limitation of this study (6) is the absence of patient follow-up. Furthermore, such aggregated association analyses are suitable for generating hypotheses but not for proving causal relationships (22). Investigations into patient safety still require a broader definition (7, 8). Ours is the first study to show that, based on the assessment by medical experts from both sectors, redirection of emergency room patients using SmED-Kontakt+ is associated with an overall potential risk of 2.7% (3.7% extrapolated to all cases). This does not fulfill the primary safety criterion of the study yet corresponds to a risk range that is also considered sufficiently safe for other emergency scenarios or for conducting clinical studies (5%). In this context, there is a lack of social agreement and legal certainty on the question of which patient safety risks should be rated acceptable when it comes to mechanisms of redirection.
Limitations
During the study, patients were not in fact redirected according to the SmED recommendation, so that the true risk that could develop as a result of redirection was not recorded. It is important to note that cases that were assessed unanimously by SmED Contact+ and the treating physicians in the emergency room or cases that were rated as more urgent by SmED Contact+ than by the treating physicians were only assessed by experts based on a five-percent sample. It is therefore possible that the proportion of cases at risk was underestimated in the present study.
Another limitation is that the outpatient resources listed in the assessment form used by the treating physicians are only available in theory. This may deviate from the true situation.
The study population was recruited prospectively from university hospitals, and a selection bias cannot be excluded (for example, language barrier). This is also an experimental use of SmED-Kontakt+: In real practice, staff would usually assess the SmED-Kontakt+ decision before actually redirecting patients and then possibly decide otherwise (over-ruling). Safety could therefore be higher under real conditions than in the study, but efficiency may have been overestimated as a result (23).
Furthermore, the proportion of patients who could potentially be redirected to other healthcare facilities was not compared with a gold standard, so the corresponding data should be evaluated exploratively. Furthermore, the experts’ assessments turned out to be very heterogeneous, often rendering necessary a supervised discussion at case conferences. In the discussion, a more safety-focused scenario with no clear definition of the outpatient care setting was assumed for the potential risk, so that the assessment was more likely to lean towards a potential risk in the event of ambiguity or uncertainty (T0). Nevertheless, the majority of cases were still rated as being at risk by at least one of the experts, even with complete knowledge of the available clinical information (T1) (n = 41). Version 7.1 of SmED-Kontakt+ was used throughout the whole study, but SmED-Kontakt+ has meanwhile been further developed, based on feedback from study staff.
Practical implications
The present study shows that around 15% of patients at a university emergency room could be redirected to SHI healthcare facilities. This would correspond to around 30 to 40 cases per day for the largest emergency departments in Germany dealing with around 80 000 to 100 000 cases per year. Treatment by SHI physicians within or after 24 hours is only recommended for a small number of cases (maximum of seven to eight cases per day) and is also associated with a high potential risk to patient safety (7 to 17%). It cannot therefore be recommended. On the other hand, redirection to immediately available outpatient healthcare facilities using SmED-Kontakt+ is safer; an uninterrupted system for monitoring patients is preferable. The prerequisite for onward referral is the availability of resources required for the provision of care (X-ray, laboratory with same-day results, ultrasound, and ECG) (12, 15). Capacity utilization of suitable SHI facilities by patients referred from the emergency room alone does not appear to be possible for the majority of emergency room locations.
Conclusion
The use of SmED-Kontakt+ for the further referral of patients from the emergency room shows a hypothetical redirection potential of around 15%. It is only possible for a very small proportion of patients to receive non-acute treatment by SHI physicians at a later time. SmED-Kontakt+ rated a large proportion of cases as more urgent than did the treating physicians (66%). The proportion of cases potentially at risk from the SmED-Kontakt+ recommendation is nevertheless higher than expected at 2.7% (one in 37 patients). In the light of the current study, further care should be provided promptly in established healthcare facilities with obligatory appointments and the care facilities to be contacted should be immediately accessible and appropriately equipped. Moreover, these healthcare facilities must be readily available and equipped with the appropriate staff and technology to meet the requirements of the case. Onward referral from the emergency room to an outpatient facility for further care at a later time based on SmED-Kontakt+ recommendation should be avoided.
Acknowledgments
We would like to express our sincere thanks to all those at the study centers who participated in conducting the study (Sylwia Steinke, Ivana Stjepic, Silke Voss, Friederike Kohlmann, Natalie Thelemann, Marco Jochum, Mona Fülle, Jan Hollander, Leonhard Berboth, Laure Wagner und Dilbe Dari) as well as to all independent experts, moderators, and treating physicians at the participating emergency rooms.
Data-sharing statement
Anonymized data from the study is available to other working groups for secondary analysis.
Funding
The study was supported by a grant from the Central Institute for Statutory Health Insurance Physicians (Zi).
Conflict of interest statement
AS and AG are members of the Expert Advisory Board of the Central Institute for Statutory Health Insurance Physicians in Germany and declare that they have received expense allowances for attending meetings of the Expert Advisory Board. AS and MM also state that they have received further grants from the Central Institute for Statutory Health Insurance Physicians for conducting other studies. AS and MM received grants from the German Research Foundation, the Federal Ministry of Education and Research, the Federal Ministry of Health, the Innovation fund of the Joint Federal Committee, the Berlin University Alliance, as well as from Thermo Fisher Scientific and Roche Diagnostics. MM has received consulting fees from Thermo Fisher Scientific, Roche Diagnostics, Sanofi, and EMCREG.
The other authors confirm that there are no conflicts of interest.
Manuscript received on June 21, 2024, revised version accepted on September 18, 2024
Translated from the original German by Dr Grahame Larkin
Corresponding author:
Prof. Dr. Anna Slagman
Emergency Medicine Health Services Research
Emergency and Acute Medicine CVK, CCM
Charité Medical University of Berlin
Charitéplatz 1, 10117 Berlin
Rescue Center
anna.slagman@charite.de
Cite this as:
Slagman A, Bremicker A, Möckel M, Eienbröker L, Fischer-Rosinský A, Gries A: Evaluation of an automated decision aid for the further referral of emergency room patients—a prospective cohort study. Dtsch Arztebl Int 2024; 121: 703–9. DOI: 10.3238/arztebl.m2024.0191
Central Emergency Department/Observation Unit, University Hospital of Leipzig Medical Center, Leipzig: Prof. Dr. med. André Gries
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