Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Aliasghar Clinical Research Development Center (AACRDC), Aliasghar Children Hospital, Department of Pediatrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Orphanet J Rare Dis. 2022 Jun 16;17(1):228. doi: 10.1186/s13023-022-02376-9.
Patients with Hemolytic Uremic Syndrome (HUS) face late diagnosis and lack of appropriate treatment because of a lack of knowledge and experience in this field. A prerequisite for such knowledge is the development of research infrastructures such as a registry system. Therefore, this study aimed to develop and describe the HUS registry in accordance with the Iranian health system and implement its software system.
We first interviewed 10 pediatric nephrologists and after analyzing the interviews, we identified the features and requirements and the data related to HUS. Then, during two rounds of the Delphi technique (the first round with 23 participants and the second round with 18 participants), the model of this registry was finalized based on the agreement of at least 75% of specialists. At the next step, based on the agreed requirements, IRI.HUS.Reg (Iranian Hemolytic Uremic Syndrome Registry) software was developed and implemented in a pediatric hospital.
We classified 369 meaning units of interviews in 41 codes and 7 final themes including purposes of the registry (10 codes), inclusion criteria (7 codes), data collection method (4 codes), data quality control (6 codes), data sources (4 codes), data analysis (3 codes) and software features (7 codes). These 7 feature groups (67 subgroups) and 12 data classes (138 data elements) include demographic data, referrals, examinations, clinical signs, causes, laboratory tests, medical histories, paraclinical measures, treatments, outcomes, patient's status at discharge, and follow-up data were reviewed by the Delphi panelists, and finally, 64 features and 131 data elements were accepted by at least 78% agreement. Then, we developed and implemented a registry software system in a hospital.
We implemented IRI.HUS.Reg based on related features, 12 data classes agreed by specialists, literature review, and comparison with other existing registries. Therefore, the data collected in this registry can be compared with other data from existing registries in other countries.
由于缺乏该领域的知识和经验,溶血性尿毒症综合征(HUS)患者面临着诊断延迟和缺乏适当治疗的问题。开展此类研究的前提是建立研究基础设施,例如登记系统。因此,本研究旨在根据伊朗卫生系统开发和描述 HUS 登记系统,并实施其软件系统。
我们首先对 10 名儿科肾病学家进行了访谈,在分析访谈内容后,我们确定了 HUS 登记系统的特征和要求以及相关数据。然后,通过两轮德尔菲技术(第一轮有 23 名参与者,第二轮有 18 名参与者),根据至少 75%专家的一致意见,确定了该登记系统的模型。下一步,根据达成的要求,在一家儿科医院开发并实施了 IRI.HUS.Reg(伊朗溶血性尿毒症综合征登记系统)软件。
我们对 369 个访谈的意义单位进行了分类,形成 41 个代码和 7 个最终主题,包括登记系统的目的(10 个代码)、纳入标准(7 个代码)、数据收集方法(4 个代码)、数据质量控制(6 个代码)、数据来源(4 个代码)、数据分析(3 个代码)和软件功能(7 个代码)。这些 7 个特征组(67 个子组)和 12 个数据类(138 个数据元素)包括人口统计学数据、转诊、检查、临床症状、病因、实验室检查、病史、辅助检查、治疗、结局、出院时患者状况和随访数据。德尔菲专家小组对这些内容进行了审查,最终至少有 78%的专家同意了 64 个特征和 131 个数据元素。然后,我们在一家医院开发并实施了一个登记系统软件。
我们根据相关特征、专家同意的 12 个数据类、文献回顾以及与其他现有登记系统的比较,实施了 IRI.HUS.Reg。因此,该登记系统中收集的数据可以与其他国家现有登记系统中的数据进行比较。