Development of a minimum data set for cardiac electrophysiology study ablation
Hadi Kazemi-Arpanahi1, Ali Vasheghani-Farahani2, Abdolvahab Baradaran2, Marjan Ghazisaeedi3, Nilofar Mohammadzadeh3, Hassan Bostan1
1 Department of Health Information Technology, Abadan School of Medical Sciences, Abadan, Iran
2 Cardiac Primary Prevention Research Center, Heart Center; Department of Cardiology, School of Medicine, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran
3 Department of Health Information Management, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran
|Date of Submission||04-Aug-2018|
|Date of Acceptance||19-Feb-2019|
|Date of Web Publication||14-May-2019|
Dr. Ali Vasheghani-Farahani
Cardiac Primary Prevention Research Center, Heart Center, Tehran University of Medical Sciences, Department of Cardiology, School of Medicine, Tehran Heart Center, Tehran University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
BACKGROUND: At present, there is no established national minimum data set (MDS) for electrophysiology study (EPS) ablation, which has led to a lack of standardization and variable assessment criteria in this context.
OBJECTIVE: The objective of this paper was to develop a MDS of EPS ablation as means of establishing an information management system or clinical registry in this field.
METHODS: In this cross-sectional and descriptive study, national and international cardiovascular scientific literature were studied to establish an initial set of data elements. In order to its validity, the population study composed of 15 cardiac electrophysiologists who asked to review the proposed data elements and score them in order of importance using a five-point Likert scale. The items scored as important or highly important by at least 60% of the experts (average score of 3 and higher) were included in the final list of MDS.
RESULTS: An MDS of cardiac EPS ablation was created with nine data classes, including administrative data, past medical history, sign and symptoms, physical examinations, laboratory tests, presenting status of heart conduction system, catheter ablation, postprocedure complications, and discharge outcomes. For each category, required variables data and possible respondents were determined.
CONCLUSIONS: Consensus was reached on a set of core data elements to standardize data collection for cardiac EPS ablation in order to achieve quality improvement and effectiveness indicators for the management of care process and health outcomes.
Keywords: Cardiac electrophysiology study, catheter ablation, minimum dataset
|How to cite this article:|
Kazemi-Arpanahi H, Vasheghani-Farahani A, Baradaran A, Ghazisaeedi M, Mohammadzadeh N, Bostan H. Development of a minimum data set for cardiac electrophysiology study ablation. J Edu Health Promot 2019;8:101
|How to cite this URL:|
Kazemi-Arpanahi H, Vasheghani-Farahani A, Baradaran A, Ghazisaeedi M, Mohammadzadeh N, Bostan H. Development of a minimum data set for cardiac electrophysiology study ablation. J Edu Health Promot [serial online] 2019 [cited 2019 Oct 19];8:101. Available from: http://www.jehp.net/text.asp?2019/8/1/101/258131
| Introduction|| |
The electrical conduction system in the heart is very complex, and disease can occur in many locations within this unidirectional electrical circuit. Clinical cardiac electrophysiology (EP) began in the late 1960s is used for the diagnosis and management of cardiac arrhythmias and conduction disorders.
 Some of arrhythmias including postinfarct arrhythmia are instantly fatal if other arrhythmias are not instantly fatal but lead to important complications such as strokes. Substantial advances in the treatment of arrhythmias as well as technological enhancements have allowed EP studies (EPSs) to be considered as an important subspecialty in cardiology. Currently, catheter ablation is the first or second line of treatment for the various cardiac arrhythmias., This procedure has remarkably high success rate and can quietly increase patient's quality of life.
There is a major effort nationally and internationally to collect data that about patients undergoing high-risk, high-cost, and high-volume procedures such as cardiac interventions.
It is most essential that health-care data can be collected in a uniform manner from a scientific perspective. Data collection is the most important part of health information management and clinical research systems; thus, development of a minimum data set (MDS) to collect data in a standard and integrated manner at the national level has made the use of it inevitable.,
An MDS is a coherent set of data elements accepted for mandatory collection and reporting at a national level. MDS also can be considered as a basis for clinical registries and plays a pivotal role as primary step required in health care, to implement an effective and operative information system. For these reasons, each variable and its associated response categories have been determined to promote the collection and reporting of comparable minimal data. In addition, a standardized format has been specified to enable the compilation of data from multiple investigators and locations.,
In order to accomplish quality enhancement, continuity care, and optimum care in the case of cardiac EPS ablation intervention, a MDS is suggested as a standard tool that can guide homogeneous data collection. To best of our knowledge, no research has been undertaken so far in order to identify MDS for cardiac EPS ablation in Iran, which it makes national and international benchmarking challenges. Therefore, the objective of this paper was to develop an MDS for cardiac EPS ablation as a means of establishing an information management system or clinical registry that could accelerate collection of reliable and detailed data from patients who have been undertaken to this cardiac invasive intervention. The specific goal of proposed MDS is to establish a consistent, interoperable, and national framework as a basis for both clinical care and research information systems.
| Methods|| |
An applied descriptive, cross-sectional study was conducted in 2018. To design this dataset, a combination of literature review and expert consensus approach was used. At first, a team of working party was presented to contribute the required skill. The research team comprised two specialists in cardiology and three experts in health information management. This gave the team the ability to develop an understanding of the research goals. An extensive literature review was undertaken in EPS-related data collection frameworks to identify potential data elements to be included in the MDS. To achieve this, at the first, a preliminary list of potential variables was extracted from international registries and other publication documents in this field;,,,,, moreover, medical records and cardiovascular forms were reviewed. Then, content validity of the questionnaire was evaluated using the comments from experts in the field of health information management and cardiology. To ensure the reliability of the questionnaire, it was completed by five of the aforementioned experts; they were requested to complete the questionnaire for the second time after 1 week. Spearman's rank correlation coefficient was used to evaluate the reliability of the questionnaire, which showed a coefficient of 85%. The completed questionnaires were analyzed using SPSS software (version 19.0, SPSS Inc., Chicago, Illinois, USA) and descriptive statistical techniques.
To determine the MDS of EPS ablation, the final data elements were chosen by 15 cardiologists with at least 3 years of work experience in medical centers performing cardiac invasive EP interventions. The experts participating in the study were asked to review the initial draft of variables to score the items according to the importance perceived by them based on a five-point Likert scale. In this scale, a score of 1 naturally represented the “lowest level of importance” and a score of 5 represented the “highest level of importance.” Only the data elements with average score of 3 and higher were allowed into the MDS. Moreover, where asked from experts if intended to change, delete, or add a variable for a specific purpose, they should write an acceptable reason.
| Results|| |
We managed to collect 15 filled questionnaires out of 15 that had been distributed (100%). The mean age of respondents was 43 years, their average work experience was 7 years, and about 28% of them were female.
The cardiac EPS ablation-MDS was divided into four categories; a first section is administrative data, that is, included patient demographic and current episode of hospitalizations. The second section is clinical EP laboratory visit that is included past medical history, sign and symptoms, physical examinations, laboratory tests, and presenting status of heart conduction system [Table 1]. The third section is data elements related to catheter ablation procedure session [Table 2]. The fourth section is postprocedure evaluation that includes postprocedure complications [Table 3], discharge outcomes [Table 4].
There was consensus to include name, last name, father's name, gender, date of birth, place of birth, marital status, education level, national number, home address, and phone number.
Current episode of hospitalization
There was consensus to include care facility name, physician name, admission date, reason for admission, insurance payers, and medical record number.
Past medical history
The first section of the clinical EP laboratory visit category is related to past medical history which was classified into four subsections of cardiovascular disease history, noncardiovascular disease history, family history of cardiovascular diseases, and prior history of cardiovascular procedures.
- History of cardiovascular diseases that included heart failure, heart failure stage, hypertrophic cardiomyopathy, nonischemic dilated cardiomyopathy (DCM), idiopathic DCM, right ventricular cardiomyopathy, restrictive cardiomyopathy, pericarditis, peripheral vascular disease, stable angina, unstable angina, non-STEMI, STEMI, primary valvular heart disease, tetralogy of Fallot, ventricular sepal defect, common ventricle, Ebstein's anomaly, atrial septal defect, amyloidosis, Chagas disease, giant cell myocarditis, left ventricular aneurysm, left ventricular noncompaction syndrome, right ventricular dysplasia, and sarcoidosis
- History of noncardiac diseases that included stroke, transient ischemic attack, chronic renal failure, currently on dialysis, chronic lung disease, diabetes mellitus, hyperthyroidism, hypothyroidism, cirrhosis disease, obstructive sleep apnea, patient life expectancy of ≥1 year by physician estimate, cancer, hyperlipidemia, hypertension, cigarette smoker, and opium addiction
- Family history of cardiovascular diseases that included family history of arrhythmias, family history of recurrent syncope, specific familial arrhythmia syndromes, family history of sudden cardiac death, family history of ischemic heart disease, and familial history of cardiomyopathy
- History of invasive cardiac interventions/surgery that included previous pacemaker (pacemaker type and pacemaker indication), previous Implantable cardioverter-defibrillator (ICD) implant (ICD type, ICD implant site, ICD implant date, and ICD indication), prior catheter ablation (number of ablation procedures, ablation target, and energy source), prior diagnostic coronary angiography, prior percutaneous coronary intervention, prior coronary artery bypass grafting, prior heart transplant, and prior valve surgery.
Sign and symptoms
This category was included of asymptomatic, fatigue, palpitations, dyspnea, chest pain, NYHA functional classification, presyncope, syncope, orthopnea, paroxysmal nocturnal dyspnea, and cardiac arrest/aborted sudden death.
This category was included of heart rate, blood pressure, respiratory rate, height, weight, third heart sound (S3), fourth heart sound (S4), lung examination, and waist circumference.
This category includes blood urea nitrogen, complete blood count, hemoglobin, platelet count, hemoglobin, hemoglobin A1c, hematocrit, white blood count, sodium, creatinine, potassium, fasting blood sugar, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, prothrombin time (PT), partial PT, and thyroid-stimulating hormone.
Since the main focus of this paper is to present a MDS of EPS ablation the tables classified these data elements.
| Discussion|| |
In the context of this study, we have demonstrated the need and feasibility for establishing EPS ablation MDS at national level that was achieved through experts' consensus following extensive discussions with a range of related expertise.
According to the results of this study, data elements were identified and subsequently categorized into the administrative, EPS laboratory visit, catheter ablation procedure, postprocedure complications, and discharge information sections. These sections including of data elements believed to be essential and sufficient for uniform reporting of EPS ablation intervention into health information system or clinical registry in this field. One of the incentives for developing an MDS is to promote health through providing high-quality information. Furthermore, the MDS could be used for monitoring the patient's condition, health-care provider or system assessment, and comparison in national and international levels, as well as serving as an indicator of health care provided by different care settings.
While the term MDS is commonly thought to describe an essential, uniform set of data elements should be collected across time and organizations. Svensson-Ranallo et al. suggest that MDS term is also widely used in health care to describe an ontology, an existing set of data elements used for a specific purpose, and a standardized protocol for collecting data.
In a study by Bauer and Sieber (2007), it has been stated that the MDS could be the first step for moving toward data standardization of malnutrition and for the evaluation of the results of the conducted studies. Mahmud et al. stated that minimum standard set of outcome measures for cataract surgery is important for meaningful comparison across contexts. Davey et al. stated that MDS should be easily integrated into clinical practice and should not be mistaken for a clinical guideline and should not add workload to the clinicians. Hawes et al. showed that an MDS provides considerable improvement in the accuracy and comprehensiveness of the information in residents' medical records, affects the comprehensiveness of the care plan, care quality, and life quality, and reduced the duration of hospitalization
We hope that our MDS will enable and accelerate improvements in the outcomes of patients who undertaken to EPS ablation intervention, by providing consistent measurement of meaningful outcomes and allowing comparison between different care providers. Data interoperability between health information systems is an important goal that has focused by much research and received significant funding worldwide. While data collection in care settings should ideally enable data reuse for epidemiology, public health, or research, it is still difficult to reuse the data produced in care setting. Therefore, one aim of developed MDS in this study is that can be used as infrastructure for data interoperability between medical information systems in clinical and research domains related to EPS ablation.
| Conclusions|| |
Due to the importance of EPS ablation as a first line in treatment of heart conduction system disorders, it is necessary to create the MDS for uniform reporting this procedure into clinical registry or electronic health record. Therefore, this study suggests comprehensive and uniform data elements in order to improve data efficiency and data quality in EPS ablation intervention. Consequently, comparability of the developed MDS from different analyses and researches will be possible in various levels. Using these data elements, it is possible to structure data collection and communication with health-care providers in a standard manner.
We acknowledge that this work does have limitations. The proposed MDS has not been widely consulted on and has been derived from consensus opinions of cardiologist physicians in Tehran heart center hospital. However, the working group has made these required data elements based on the best currently available appropriate evidence and a vast collective wealth of experience. Moreover, it is not possible to comprehensively collect all the data items which limit the practicality of the MDS; however, this will be outweighed by providing the most required data elements and possible subcategories. Nevertheless, the MDS developed in the current study could be updated by specialists in other heart central hospitals to develop cardiac EP registries or information systems in this field. Once completely accepted and applied, this MDS will be suitable in facilitating clinical research, registry reporting, administrative reporting and regulatory compliance, and all aspects of patient undertaken to EPS ablation procedure. Future studies on this subject are recommended to use Delphi studies in focus groups to develop other application-specific MDSs and information system capabilities for other domains of cardiovascular diseases.
This study was part of the first author's PhD dissertation, which was supported by a grant from Tehran University of Medical Sciences. I would like to thank all cardiologists who participated in this study and played a role in the validation of the data elements.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]