Nickel Christian Hans, Messmer Anna Sarah, Ghanim Leyla, Ilsemann-Karakoumis Julia, Giersdorf Sven, Hertel Sabine, Ernst Susanne, Geigy Nicolas, Bingisser Roland
From the Emergency Department, University Hospital, Basel (CHN, ASM, LG, JI-K, RB); Emergency Department, Kantonsspital Baselland, Liestal, Switzerland (NG); Research Department, Thermo Scientific Biomarkers, Hennigsdorf, Germany (SG, SH); and Emergency Department, Kantonsspital Olten, Olten, Switzerland (SE).
Medicine (Baltimore). 2016 Jan;95(1):e2395. doi: 10.1097/MD.0000000000002395.
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.
前往急诊科（ED）就诊的非特异性主诉（NSC）患者存在危及生命状况的风险。新的应激生物标志物，如肾上腺髓质素中段（MR-proADM）有望为决策提供支持。本研究检验了以下假设：生物标志物辅助处置NSC患者不会增加死亡率。其次，如果将临床风险评估与低水平的MR-proADM相结合，急诊科的出院人数将会增加。第三，如果将临床评估与高水平的MR-proADM相结合，向下一级护理机构的不适当处置将会减少，第四，该算法在急诊科环境中是可行的。一项前瞻性、多中心、随机、对照的介入性可行性研究，随访30天，纳入NSC患者。患者被随机分配至标准组（仅基于临床评估进行决策）或Novum组（生物标志物辅助）。关于处置，患者被分为3个风险类别之一：高风险（住院）、中度风险（社区老年医院）和低风险患者（出院）。在Novum组中，除了临床风险评估外，还使用了MR-proADM水平的信息。除非有否决标准，患者根据风险评估进行转诊或出院。主要终点是30天死亡率。次要终点是患者处置情况及相关死亡率、急诊科和住院时间以及再入院情况的比较。最终研究队列由398例患者组成（标准组210例，Novum组188例）。有51例出现否决情况，即处置未按照所提议算法的结果进行。标准组和Novum组之间的基线特征相似。Novum组的死亡率为4.3%，而标准组的死亡率为6.2%，差异无统计学意义（意向性分析）。这在符合方案分析以及敏感性分析中也得到了证实。对于次要终点，未检测到显著差异。生物标志物辅助处置对NSC患者是安全的。出院率没有增加。由于否决率意外较高，可行性仅部分得到证明。向下一级护理机构的不适当处置没有改变。ClinicalTrials.gov标识符：NCT00920491。
