| 北京市SARS医疗救治指挥中心科技攻关组.北京市SARS临床诊断病例数据库的设计、过程、质控及评估[J].Chinese journal of Epidemiology,2004,25(4):302-307 |
| 北京市SARS临床诊断病例数据库的设计、过程、质控及评估 |
| The 'Beijing clinical database' on severe acute respiratory syndrome patients: its design, process, quality control and evaluation |
| Received:November 09, 2003 |
| DOI： |
| KeyWord: 严重急性呼吸综合征 数据库 临床流行病学 |
| English Key Word: Severe acute respiratory syndrome Database Clinical epidemiology |
| FundProject:国家SARS科技攻关重大项目;国家“863”课题(2003AA208107);北京市卫生局基金 |
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| Abstract: |
| 目的 建立北京市严重急性呼吸综合征(SARS)临床诊断病例资料数据库,为相关临床研究提供坚实基础。方法 由北京市SARS救治指挥中心组织有关专家设计,分为首诊、生命体征、症状体征、治疗、实验室检查、住院花费6个分库,共包含686个项目。由医护人员经培训后采用统一的专用录入程序进行录入。然后经过(1)专用程序检查验收;(2)5%病历逐项核对;(3)转院病历链接;(4)文字信息编码转换;(5)标准数据库结构转化;(6)计算机程序依据2003年5月3日卫生部标准核实诊断;(7)剔除不合格病例等步骤,最终形成数据库。结果 数据库最终纳入被核实的临床诊断病例2148例,资料完整病例1291例。全部病例和资料完整病例比较结果表明:两者在性别、年龄、职业和居住地构成上几乎完全相同,发病时间曲线近于重合;除少数首诊指标外,完整病例各项指标的数据完整率与全部病例无明显差异。数据库中,首诊信息数据完整率73%～100%;主要症状体征信息数据完整率接近90%;各种药物和氧气治疗信息的数据完整率均近100%;生命体征信息中体温和脉搏数据完整率分别为98%和90%;转归信息完整率100%,住院花费信息完整率98%。结论北京市SARS临床病历数据库所收录的病例数量较完整,且其中的资料完整病例对全部病例具有很好的代表性;临床基本指标的数据完整情况总体上令人满意,适宜开展相关临床研究. |
| English Abstract: |
| Objective To develop a large database on clinical presentation, treatment and prognosis of all clinical diagnosed severe acute respiratory syndrome (SARS) cases in Beijing during the 2003 "crisis", in order to conduct further clinical studies. Methods The database was designed by specialists, under the organization of the Beijing Commanding Center for SARS Treatment and Cure, including 686 data items in six sub--databases: primary medical--care seeking, vital signs, common symptoms and signs, treatment, laboratory and auxiliary test, and cost. All hospitals having received SARS inpatients were involved in the project. Clinical data was transferred and coded by trained doctors and data entry was carried out by trained nurses, according to a uniformed protocol. A series of procedures had been taken before the database was finally established which included programmed logic checking, digit--by--digit check on 5 % random sample, data linkage for transferred cases, coding of characterized information, database structure standardization, case reviewe by computer program according to SARS Clinical Diagnosis Criteria issued by the Ministry of Health, and exclusion of unqualified patients. Results The database involved 2148 probable SARS cases in accordant with the clinical diagnosis criteria, including 1291 with complete records. All cases and record- complete cases showed an almost identical distribution in sex, age, occupation, residence areas and time of onset. The completion rate of data was not significantly different between the two groups except for some items on primary medical--care seeking. Specifically, the data completion rate was 73 % - 100 % in primary medical--care seeking, 90 % in common symptoms and signs, 100 % for treatment, 98 % for temperature, 90% for pulse, 100% for outcomes and 98% for costs in hospital. Conclusion The number of cases collected in the Beijing Clinical Database of SARS Patients was fairly complete. Cases with complete records showed that they could serve as excellent representatives of all cases. The completeness of data was quite satisfactory with primary clinical items which allowed for further clinical studies. |
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