通过医嘱信息评估胃癌术后并发症登记情况的单中心可行性研究

Evaluation of postoperative complications registration status of gastric cancer by medical information: A single center feasibility study

目的 探讨通过医嘱信息评估并发症登记情况的可行性.方法 采用描述性病例系列研究方法,回顾性收集北京大学肿瘤医院胃肠肿瘤中心一病区收治的胃癌手术患者临床资料.病例入选标准:(1)胃镜及活检确诊为腺癌;(2)行开腹或腹腔镜胃癌根治手术;(3)术后医嘱信息及并发症资料完整.排除术后直接转入ICU治疗和急诊手术的病例.本中心并发症登记流程在2018年前后存在差异,故选取2016年11月1日至2017年3月1日(第一时间段组)及2018年11月1日至2019年3月1日(第二时间段组)符合上述标准的患者进行分析.完整查阅患者住院期间的医嘱信息(包括护理、药物、检验检查、转科、手术医嘱等),通过与本中心现行胃癌治疗标准作业程序(SOP,包括术前常规检验、检查、围手术期预防性抗生素使用和术后观察性检验、检查、常规营养支持、预防性抗凝以及预防性抑制胰酶等)进行比对,超出SOP的医嘱界定为医嘱变异.术后并发症诊断采用Clavien-Dindo分级标准,分为Ⅰ、Ⅱ、Ⅲa、Ⅲb、Ⅳa、Ⅳb和Ⅴ级.分析比较两个时间段内的医嘱变异和并发症登记信息,包括统计医嘱变异与并发症登记一致和医嘱变异漏报、报轻和报重以及医嘱变异登记率[医嘱变异登记率=(患者总数-漏报人数)/患者总数]、严重并发症(Clavien-Dindo分级≥Ⅲ级),偏离SOP的医嘱变异具体情况及对应推断的并发症分级.采用Microsoft Office Excel 2010整理数据.结果 共177例胃癌患者的资料纳入分析,第一和第二时间段组的病例数分别为89例和88例.第一和第二时间段组登记的并发症发生率分别为23.6%(21/89)和36.4%(32/88);严重并发症发生率分别为2.2%(2/89)和4.5%(4/88).从医嘱变异推断的第一和第二时间段组并发症发生率分别为74.2%(66/89)和78.4%(69/88),严重并发症发生率则分别为7.9%(7/89)和4.5%(4/88).第一和第二时间段组医嘱变异与并发症登记一致的病例数及比率分别为32例(36.0%)和40例(45.5%),医嘱变异报轻分别为5例(5.6%)和4例(4.5%),医嘱变异报重分别为4例(4.5%)和4例(4.5%),医嘱变异漏报分别为48例(53.9%)和40例(45.5%).第一和第二时间段组医嘱变异登记率分别为46.1%(41/89)和54.5%(48/88).第一和第二时间段组医嘱变异对应并发症分级为Ⅰ级的例数分别为34例(38.2%)和25例(28.4%),而Ⅱ级的例数分别为12例(13.5%)和15例(17.0%).第一和第二时间段组对应Ⅰ级并发症的医嘱变异漏报原因均以SOP外止痛药物单次使用为主,分别占76.5%(26/34)和64.0%(16/25);而对应Ⅱ级并发症的医嘱变异漏报原因均以术后非预防性抗生素使用为主,分别为9/12例和5/15例.结论医嘱信息评估并发症登记可行、有效;需要关注并发症例行登记并避免漏报情况.

Objective To explore the feasibility of assessing complications registration through medical information. Methods A descriptive case series study was performed to retrospectively collect medical information and complication registration information of gastric cancer patients at Department of Gastrointestinal Cancer Center Ward I, Peking University Cancer Hospital from November 1, 2016 to March 1, 2017 (the first period), and from November 1, 2018 to March 1, 2019 (the second period). Case inclusion criteria:(1) adenocarcinoma confirmed by gastroscopy and biopsy;(2) patients undergoing open surgery or laparoscopic radical gastrectomy;(3) complete postoperative medical information and complication information. Patients who were directly transferred to ICU after surgery and underwent emergency surgery were excluded. Because difference of the complication registration procedure at our department existed before and after 2018, so the above two periods were selected to be used for analysis on enrolled patients. The prescription information during hospitalization, including nursing, medication, laboratory examination, transference, surgical advice, etc. were compared with the current Standard Operating Procedure (SOP, including preoperative routine examinations, inspection, perioperative preventive antibiotic use, postoperative observational tests, inspection, routine nutritional support, prophylactic anticoagulation, and prophylactic inhibition of pancreatic enzymes, etc.) for gastric cancer at our department. Medical order beyond SOP was defined as medical order variation. Postoperative complication was diagnosed using the Clavien - Dindo classification criteria, which was divided into Ⅰ,Ⅱ,Ⅲa,Ⅲb,Ⅳa,Ⅳb, and Ⅴ. Medical order variation and complication registration information were compared between the two periods, including consistence between medical order variation and complication registration, missing report, underestimation or overestimation of medical order variation, and registration rate of medical order variation [registration rate =(total number of patients -number of missing report patients)/total number of patients], severe complications (Clavien - Dindo classification ≥Ⅲ), medical order variation deviating from SOP and the corresponding inferred grading of complication. The data was organized using Microsoft Office Excel 2010. Results A total of 177 gastric cancer patients were included in the analysis. The first period group and the second period group comprised 89 and 88 cases, respectively. The registrated complication rate was 23.6%(21/89) and 36.4%(32/88), and the incidence of severe complication was 2.2%(2/89) and 4.5%(4/88) in the first and the second period, respectively. The complication rate inferred from medical order variation was 74.2%(66/89) and 78.4%(69/88), and the incidence of severe complication was 7.9%(7/89) and 4.5%(4/88) in the first and second period, respectively. In the first and second period, the proportions of medical order variation in accordance with registered complication were 36.0% and 45.5% respectively;the proportion of underestimation, overestimation and missing report were 5.6% and 4.5%, 4.5% and 4.5%, 53.9% and 45.5%, respectively;the registration rate of medical order variation was 46.1% and 54.5%;the number of case with grade Ⅰ complications inferred from medical order variation was 34 (38.2%) and 25 (28.4%), respectively;and the number of grade Ⅱ was 12 (13.5%) and 15 cases (17.0%), respectively. The reason of the missing report of medical order variation corresponding to grade I complication was mainly the single use of analgesic drugs outside SOP, accounting for 76.5%(26/34) and 64.0%(16/25) in the first and second period respectively, and that corresponding to grade Ⅱ complication was mainly the use of non - prophylactic antibiotics, accounting for 9/12 cases and 5/15 cases, respectively. Conclusions Medical information can evaluate the morbidity of complication feasibly and effectively. Attention should be paid to routine registration to avoid specific missing report.