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Patients with nonspecific complaints (NSC) presenting to the emergency department (ED) are at risk of life-threatening conditions. New stress biomarkers such as the midregional portion of adrenomedullin (MR-proADM) promise to support decision-making. This study tested the following hypotheses: biomarker-assisted disposition of patients with NSC will not increase mortality. Second, discharge from the ED will increase if clinical risk assessment is combined with low MR-proADM levels. Third, inappropriate disposition to a lower level of care will decrease, if clinical assessment is combined with high MR-proADM levels, and fourth that this algorithm is feasible in the ED setting. Prospective, multicenter, randomized, controlled interventional feasibility study with a 30-day follow-up, including patients with NSC. Patients were randomly assigned to either the standard group (decision-making solely based on clinical assessment) or the Novum group (biomarker-assisted). Regarding disposition, patients were assigned to 1 of 3 risk classes: high-risk (admission to hospital), intermediate risk (community geriatric hospital), and low-risk patients (discharge). In the Novum group, in addition to clinical risk assessment, the information of the MR-proADM level was used. Unless there were overruling criteria, patients were transferred or discharged according to the risk assessment. Primary endpoint was 30-day mortality. Secondary endpoints were comparisons of patient disposition and related mortality rates, ED, and hospital length of stay and readmission. The final study cohort consisted of 398 patients (210 in the Standard group and 188 in the Novum group). Overruling, that is, disposition not according to the result of the proposed algorithm occurred in 51 cases. Baseline characteristics between Standard and Novum groups were similar. The mortality rate in the Novum group was 4.3%, as compared to the Standard group mortality of 6.2%, which was not significantly different (intention-to treat analysis). This was confirmed by the perprotocol analysis as well as by sensitivity analysis. For the secondary endpoints, no significant differences were detected. Biomarker-assisted disposition is safe in patients with NSC. Discharge rates did not increase. Feasibility could only partly be shown due to an unexpectedly high overruling rate. Inappropriate disposition to lower levels of care did not change. ClinicalTrials. gov Identifier: NCT00920491.

Objective: To determine the proportion of correct emergency department (ED) diagnoses and of hospital discharge diagnoses, in comparison with final diagnoses at the end of a 30-day follow-up, in patients presenting with nonspecific complaints (NSCs) to the ED; to determine differences between male and female patients in the proportion of missed diagnoses., Methods: Prospective observational study. Diagnoses made at the ED, hospital discharge diagnoses, and final diagnoses were compared., Results: Of 22,782 nontrauma patients presenting to the ED from May 2007 until May 2009, 9,926 were triaged as emergency severity index level 2 or 3, of whom 789 presented with NSCs. After exclusion of 217 patients, 572 were included for final analysis. The final diagnosis at the end of follow-up was taken to be the correct "gold standard" diagnosis. In 263 (46.0%) patients, this corresponded to the primary ED diagnosis, and in 292 (51%) patients to the hospital discharge diagnosis. The most frequent final diagnoses were urinary tract infections (n=49), electrolyte disorders (n=40) and pneumonia (n=37), and were correctly diagnosed at the ED in 23, 21 and 27 patients, respectively. Of the twelve most common diagnoses (corresponding to 354 patients), functional impairment was most frequently missed. Among these 354 patients, diagnoses were significantly more often missed in women than in men (142 of 231 [62%] women vs 57 of 123 [46%] men, p=0.004)., Conclusion: Patients presenting to the ED with NSCs present a diagnostic challenge. New diagnostic tools are needed to help in the diagnosis of these patients.