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Essential data elements for electronic cardiovascular medical record systems in Iran

1 Associate Professor, Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran 2 Department of Health Information Technology, Faculty of Para-Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran 3 Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran


INTRODUCTION
Cardiovascular diseases (CVDs) are among important causes of disability and death in the world [1]. According to the World Health Organization (WHO), CVDs are the number 1 cause of death in the world and 17.9 million people annually die from CVDs. This accounts 31% of all deaths globally [2]. The 2020 report from American Hospital Association indicates that almost 17.8 million deaths are attributed to CVDs globally, which indicates a 21.1% increase from 2007.
The age-adjusted death rate per 100 000 is 233.1 which represents a 10.3% decrease from 2007. Overall, the crude prevalence of CVDs is 485.6 million cases in 2017, a 28.5% increase and the age-adjusted prevalence rate is 6081.6 per 100 000, and 0.2% increase from 2007 [3]. Based on the WHO, over 75% of CVDs-related deaths are occurred in low and middle income countries [2]. A study in 2017 in Iran showed that cardiovascular disease accounted for 33-38 percent of deaths (approximately 26-30 million) and 23 percent of disabilities (approximately 18 million) [4].
Accurate and exchangeable health information is an essential prerequisite for providing optimal health care and the fragmented information also has undesirable effects on current and future health care for patients and consequently imposes high costs on health care systems [5]. However, most medical records of patients with cardiovascular diseases are also paper-based, and existing information systems support a limited specialized data set in this field [6]. Furthermore, poor and non-standard documentation of health information in medical records of these patients leads to poor management of the disease, which has negative consequences for patients [1].
Paper records do not meet the needed standards for health information systems. Therefore, application of computerized health information systems, especially, electronic medical records (EMR) has expanded [7]. Minimum Data Set (MDS) is required to collect quality data and is a prerequisite for developing electronic medical record systems (EMR) [8][9][10]. Therefore, the development of data sets in a uniform and standardized format at the national level could be the most important step to develop EMR systems [11,12].
Some studies have been conducted worldwide to introduce standardized data sets for cardiovascular diseases for different purposes [13][14][15][16]; however, only two studies have specifically focused on developing data sets for cardiovascular EMRs/EHRs [13,14]. Jeffery et al data elements for outpatient EMRs for pediatrics which contained 102 general concepts and eight categories [13]. Weintraub et al. also provided a list of data elements for electronic health records for cardiovascular diseases [14]. In Iran, many studies have been conducted to develop and standardize data sets for documentation of patients' health data in electronic systems [12,17,18]; however, to our knowledge, there is no study regarding to the development of data sets for a cardiovascular EMR system.
Considering the importance of cardiovascular diseases and given that to developing an EMR for cardiovascular diseases requires the development of data elements, this study aimed to determine the essential data elements for cardiovascular EMR in Iran so that system developers can develop a cardiovascular EMR system based on agreed-upon data elements.

MATERIAL AND METHODS
This descriptive cross-sectional study conducted in two phases. In the first phase, 50 paper-based medical records of patients with cardiovascular disease from Hazrat Rasoul hospital were randomly selected based on the ICD-10 blocks of cardiovascular diseases (five records from each block). The content of medical records was reviewed and the data items had been documented in each record were extracted using a data extraction form. In addition, all standardized clinical and administrative forms in this hospital were reviewed. We classified the identified data elements in several categories. Furthermore, the related literature was reviewed to identify related data elements [13][14][15][16]19].
In the second phase, a questionnaire contained different cardiovascular data elements identified from previous phase was developed. The questionnaire included a list of data elements in 29 classes (admission, death, patients' main complaints, clinical signs, observations, medicine, cardiac surgery, risk factors, laboratory and pathology, consultation, resuscitation, anesthetic, electrocardiography, blood transfusion or blood products, rehabilitation measures, angiography/venography, exercise testing, endoscopy/colonoscopy, medical imaging, echocardiography, nursing interventions, allergies and side effects, implantable remedies, cardiac examinations, physical examinations, angina, referrals, social backgrounds and history). The answer of each question had two options: necessary or not necessary. Content of the questionnaire was validated by three cardiovascular specialists, health information management and medical informatics experts. To evaluate the reliability of questionnaire, Richardson's coefficient method was used (0.975) which indicates a very high reliability of the instrument.
The sample consisted of all 87 cardiovascular specialists and residents and 50 nurses of cardiovascular wards of all hospitals affiliated with Iran University of Medical Sciences. The questionnaire was distributed to the physicians and nurses and they were asked to identify the necessity of each data elements. From 137 distributed questionnaires, 99 questionnaires were completed and collected (Response rate was 72.2%).
Data were analyzed using descriptive statistics in SPSS software (version 22) and frequency and percentage were calculated for each data element. Data elements with a high agreement (at least 75% of participants considered it as necessary) were selected as the main data elements for cardiovascular EMRs.

RESULTS
According to Table 1, the total number of participants was 99, 56.5% of whom were female. The highest age group was 30-40 years old (60.6%). Most of the participants had 5-10 years of experiences. Among them, 52.5% were physicians. Table 2 shows the frequency of data elements for cardiovascular electronics medical records. Most of the data elements were related to the history class (18%), risk factors (11%) and clinical symptoms (10%). Table 3 also presents the approved data elements as well as the deleted data elements for each class.   Main data classes Approved data elements Deleted data elements S2 heart sound, Location of heart sounds, Heart sounds (murmur phase), Heart sounds (heart murmurs), Heart sounds( time), Heart sounds (heart murmurs), Heart murmurs (features) Physical examination

DISCUSSION
Information management is one of the most important issues in the diagnosis and treatment of cardiovascular diseases. Developing data elements for cardiovascular diseases facilitate the continuous, accurate and complete documentation of patients' information using standardized terms used to describe cardiovascular diseases and interventions [15]. However no research has been conducted to determine the data elements for Iranian EMRs for cardiovascular diseases. In the first step, it is founded that cardiovascular diseases were not documented very well paper-based medical records. According to our results, among 276 suggested data elements for cardiovascular EMRs, 244 data elements were approved and classified into 29 different classes including admission, death, main complaints, clinical signs, observations, medications, cardiac surgery, risk factors, laboratory and pathology, consultation, resuscitation, anesthesia, electrocardiography, blood transfusion or blood products, rehabilitation measures, angiography/venography, exercise test, endoscopy/colonoscopy, medical imaging, echocardiography, nursing interventions, allergies and side effects, implants, cardiac examinations, physical examination, angina, transmissions, social backgrounds, and history.
Jeffrey et al. [13] considered an outpatient EMR for congenital and pediatric cardiovascular diseases and suggested different data elements including physical examinations, clinical signs, and cardiac examinations as key data elements. These findings are consistent with our results regarding the required data elements for an EMR for patients with cardiovascular diseases. Additionally, Asselbergs et al. [16] conducted a study to identify standardized clinical data elements in cardiovascular patients for optimal care, quality control, and research. In this study, demographic data elements (date of birth, age, gender, membership date), general aspects (physicians' treatment for referrals), medical history (acute myocardial infarction, myocardial infarction, aneurysm, coronary artery bypass surgery, ischemia attack), chronic kidney disease, hypertension, high blood lipids, history of delivery, family history of cardiovascular disease, lifestyle (physical activity, alcohol consumption, smoking), physiological measurements (height, weight, blood pressure, heart rate), laboratory measurements (blood lipids, triglycerides, cratine, hemoglobin), heart failure, cerebral ischemia, arterial aneurysm, diabetes and hypertension are considered essential. These data elements are also considered necessary in our study and were included in the medical history data elements, social context, clinical symptoms, and laboratory data classes. Weintraub et al. [14] also introduced a list of data elements including history and physical examinations, family history, patient evaluation data, laboratory data, cardiac therapies, cardiac implants, and medicines which are consistent with our study.
Some limitations of this study should be considered. Reviewing the medical records in the first step was done only at the Hazrat Rasoul Hospital. Additionally the participants were also from hospitals affiliated with Iran University of Medical Sciences. Therefore, the results may not be generalizable to the whole country.
In this study, we considered the data elements for general EMR for cardiovascular diseases and we did not focus on a specific type of disease. CVDs includes a variety of diseases such as coronary heart disease, congenital heart diseases, etc. which may require more specialized data elements. Therefore, more studies in this regard are highly recommended.

CONCLUSION
There is no standard in Iran for necessary data elements for EMRs for cardiovascular diseases. Therefore, introduction and standardization of data elements required for EMRs for patients with cardiovascular diseases are necessary. This study introduced 244 data elements in 29 different classes for electronic cardiovascular medical records.