A minimum data set for traumatic brain injuries in Iran.

PURPOSE: Traumatic brain injury (TBI) is one of the major public health concerns worldwide. Developing a TBI registry could facilitate characterizing TBI, monitoring the quality of care, and quantifying the burden of TBI by collecting comparable and standardized epidemiological and clinical data. However, a national standard tool for data collection of the TBI registry has not been developed in Iran yet. This study aimed to develop a national minimum data set (MDS) for a hospital-based registry of patients suffering from TBI in Iran.
METHODS: The MDS was designed in 2 phases, including a literature review and a Delphi study with content validation by an expert panel. After the literature review, a comprehensive list of administrative and clinical items was obtained. Through a two-round e-Delphi approach conducted by invited experts with clinical and research experience in the field of TBI, the final data elements were selected.
RESULTS: A MDS of TBI was assigned to 2 parts: administrative part with 5 categories including 52 data elements, and clinical part with 9 categories including 130 data elements.
CONCLUSION: For the first time in Iran, we developed a MDS specified for TBI consisting of 182 data elements. The MDS would facilitate implementing a TBI's national level registry and providing essential, comparable and standardized information.

Introduction

Traumatic brain injury (TBI) is one of the major public health concerns worldwide as it results in considerable mortalities and lifelong devastating physical, cognitive and emotional morbidities. This poses significant social and economic burdens on patients, families, and societies. The prevalence of TBI has been increasing since 1990. In 2016 the number of TBI victims was estimated to be 55.5 million individuals around the world.1, 2, 3 Globally, organizations such as the International Initiative for Traumatic Brain Injury Research have launched international collaborative research since 2010 and developed a standardized data collection called Common Data Elements for TBI.4, 5, 6, 7 However, in low- and middle-income countries (LMICs), due to TBI-related limited research funding and efforts, a high-quality data-specific registry at the national level is scarce. Meanwhile, the evidence carried out in high-income countries is not translatable and applicable for LMICs owing to far differences in their care strategies and resources. A TBI-specific registry in which comparable and standardized epidemiological and clinical data are collected is an advantageous mechanism to characterize TBI, quantify its true magnitude and economic and social burdens caused by this injury in LMICs. Besides, it could assist in monitoring and evaluating the quality of care and converting the research results into recommendations for more effective management of clinical conditions. As mentioned before, there is an unmet need for developing a national registry system and minimum data set (MDS) for TBI in LMICs. A MDS tool specifically concerning TBI could provide a set of standardized minimum data for each patient suffering from TBI and unifing definitions for terms and data elements. The data generated from studies implementing the MDS will be comparable and consistent at national and international levels. This would enable researchers and health care professionals to enhance basic and clinical research and practices. This study aimed to develop a national MDS for a hospital-based registry of TBI patients in Iran.

Methods

The MDS was designed in 2 phases, including a literature review and a Delphi study with content validation by an expert panel.

The literature search was performed using keywords in MEDLINE (via PubMed) and Google Scholar in January 2019. In PubMed, the Medical Subject Headings (MeSH) terms “Brain Injuries”, “Data Collection”, “Common Data Elements”, and “Registries” were used. In addition, the Google search engine was used to find the scientific association publications related to the registration of TBI patients. Inclusion criteria were currently ongoing registries and English language. Two researchers extracted all the data elements independently and determined a comprehensive list of administrative and clinical items.

Through a 2-round e-Delphi approach, the final data elements were chosen by 16 invited experts with clinical and research experience in the TBI field. They were informed about the study's process. The experts should only consider the feasibility (or applicability) of elements whose main criteria, including validity, reliability, sensitivity, and specificity were already proven. To this end, they were asked to choose elements with respect to local capacity and limitations of registries, hospital settings, and health care resources in Iran. An online questionnaire was developed which contained dichotomous questions (agree/disagree answers) concerning the necessity of each data element. Each item with more than 75% agreement was included, and one with less than 50% agreement was excluded in the first round. In the second round, the items with 50%–75% agreement were surveyed again, and if there was 75% consensus over a subject, it was included.

Results

Three hundred data elements were compiled in the final list from 3 current large multi-center TBI-registries9, 10, 11 and a national institute of data standardization in the United States. The data elements were classified into 2 parts, including administrative and clinical data (Table 1, Table 2). Fourteen experts participated in the Delphi process, 79% of whom had more than 10 years of experience in trauma center hospitals. In the first round, 152 items were marked as definitive, 58 items were deleted, and 89 items were moved to the next round. In the second round, the experts removed 59 items and accepted 30 items. The resulting MDS had 2 parts, 14 categories, 22 subcategories, and 182 items (Table 1, Table 2, colored cells).

Table 1

Administrative data elements related to traumatic brain injury inpatients.

Table 2

Clinical data elements related to traumatic brain injury inpatients.

In the first round, items related to the “Injury” and “Post-Discharge Status” categories were approved more than other categories (n = 17, 94.4%; n = 35, 94.6%, respectively). At the end of the process, “Post-Discharge Status” and “Socioeconomic Status” classifications had the highest and lowest approval rating, respectively (n = 36, 97.3%; n = 8, 20%).

Table 3 shows 4 included data standards and the number of data elements. The present MDS was the most adapted according to the National Institute of Neurological Disorders and Stroke and the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (73.6% and 72.5%, respectively).

Table 3

Included data standards and number of data elements.

Included data standards	Number of elements
	All	Extracted for 1st round, n = 300	Kept after 2nd round, n = 182	Specific for present MDS
Collaborative European neuro-trauma effectiveness research in TBI 9	56	29	22	0
Transforming research and clinical knowledge in TBI 10	417	182	132	12
International mission for prognosis and analysis of clinical trials in TBI11	198	126	95	2
National institute of neurological disorders and stroke 12	526	188	134	36

MDS: minimum data set, TBI: traumatic brain injury

The inclusion criteria were considered as patients with TBI who would present at the hospital within 24 h of injury and require an emergency brain CT scan per the Canadian CT Head Rule.

Discussion

For the first time in Iran, we established a TBI-specific MDS comprising 181 data elements. It would facilitate implementing a national-level TBI registry. To date, a handful of studies regarding TBI have been conducted sporadically in Iran; however, the data were not recorded systematically and did not provide sufficient, comparable, and standardized basic information.14, 15, 16, 17

Compiling data elements from current large studies collaborating in the International Initiative for Traumatic Brain Injury Research could be one of the strengths of the MDS. Benefit from the good updated resources could result in providing standard and consistent MDS at the international level.9, 10, 11, 12 In addition, applying the Delphi technique would lead to developing the MDS based on the collective knowledge of experts in the field.

Among the reference studies, the approved data elements of our MDS were to a greater extent identical to the National Institute of Neurological Disorders and Stroke as a consistent structure of the Common Data Elements for TBI that could ensure compatibility of MDS.

Data element determination and the level of details should depend on the aim of the study. In designing the current MDS, the administrative and clinical data elements were collected according to the requirements of a hospital-based registry. Consideration of scopes, resources, and capacities could be critical to the success of a registry. Eventually, although we made our best effort to develop a reliable, high-valued MDS concerning TBI, this MDS should undertake pilot studies in Iran in the future to identify its limitations and deficiencies.

Funding

This study was supported by grant number 43012 from Sina Trauma and Surgery Research Center, , Tehran, Iran.

Ethical statement

The study was reviewed and confirmed by the Ethics Committee of Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Declaration of competing interest

The authors declare that they have no conflicts of interest.

Author contributions

Hamid Reza Khayat Kashani designed the original idea. Maryam Edalatfar and Mohsen Sadeghi-Naini carried out the study and collected data. Maryam Edalatfar and Mitra Movahed prepared the manuscript. Mahdi Sharif-Alhiseini supervised the study.