Designing a minimum data set for the information management system (registry) of spinal canal stenosis: An applied‐descriptive study

Abstract Background and Aims Spinal canal stenosis is one of the most common vertebral column diseases, which can lead to disability. Developing a registry system can help in research on the prevention and effective treatment of it. This study designs a minimum data set (MDS) as the first step in creating a registry system for spinal canal stenosis. Method The present research is of applied‐descriptive type, performed in 2022. First, the applicable data elements about the disease were selected from a vast range of English and Farsi references, including peer reviewed articles, academic books, credible websites, and medical records of hospitalized patients. Through the extracted data, the primary MDS plan was designed as a questionnaire. The validity of the questionnaire was conducted via asking the opinion of experts (neurosurgeons, physiotherapists, epidemiologists, and health information management specialists). Also, its reliability was calculated via Cronbach ⍺ coefficient, which was 86%. Finally, the MDS of the spinal canal stenosis national registry system (for Iran) was confirmed through a two stage Delphi technique. Data analysis was applied through descriptive statistics via SPSS21 software. Results The proposed MDS is offered in two general sets of data: administrative and clinical. For the administrative data set, 40 data elements had been proposed, as five classes. Twenty‐six of them were confirmed. In the clinical section, 95 data elements had been proposed in 14 classes; 94 of which were finally confirmed. Conclusion Since there is no spinal canal stenosis MDS available, this study can be a turning point in the standardization of the data on this disease. Moreover, these precise, coherent, and standard data elements can be contributed to improving disease management and enhancing the public healthcare quality. Also, the MDS proposed in this study can help researchers and experts, design a spinal canal stenosis registry system in other countries.


| INTRODUCTION
Spinal canal stenosis refers to abnormal narrowing of the spinal canal, which may occur in the cervical, thoracic, and lumbar regions.The main reason for stenosis is degeneration of the spinal elements including intervertebral disc and ligament flavum. 1,2Based on the criteria defined by the North American Vertebral Column Society, the most salient symptom of spinal canal stenosis is gluteal or lower limb pain, which aggravates with walking, standing, or back stretching, while improving with forward bending, sitting, or sleeping. 3The pain results from the constrained space available to neurovascular elements of the lumbar vertebral column. 4e degeneration becomes more intense with aging.The disease is one of the most important reasons of spinal injuries and diminished mobility among the people above 50 years old.This may be related to Osteoarthritis, which initiates changes in the vertebral column at age of 50. 5,6Moreover, the prevalence of this disease increases at advanced ages.It is estimated that 400,000 people in the United States, mostly within the age range 60−69 years, have been affected by spinal canal stenosis.Forty-seven percent of this age group has mild to moderate, and 19.7% of them have severe stenosis. 7Women are more at risk of developing spinal canal stenosis compared to men. 8 In the United States, the healthcare costs associated with the back pain resulting from spinal canal stenosis have been estimated at 65 billion dollars annually.Furthermore, the indirect costs including loss of working days and production have been estimated at more than 170 billion dollars in total. 9e to ageing of the world population, the incidence of degenerative spinal canal stenosis and its associated economic burden are growing. 2,10This intensifies the necessity of research to improve healthcare and management of the disease.In 2021, the International Workshop on Diagnosis and Management of spinal canal stenosis was established with the support of the International Association of Studying Lumbar Vertebral Column to address some of the current challenges in spinal canal stenosis care provision. 2In addition, some registry systems have been created in recent years in different countries for registering vertebral column disorders, such as spinal canal stenosis.The examples include (NOR spine) 11,12 and the Swedish spine register (Swespine). 13e of the most essential stages in designing a registry system related to a special disease is determining it's minimum data set (MDS). 14,15Launching a spinal canal stenosis population registry system provides the opportunity of recording data on a large scale during the routine care of patients.These data can be a valuable source for evidence-based medicine and healthcare policies. 12In other words, MDS has a positive effect on the precise and comprehensive presentation of information on medical history, facilitation of healthcare plans, and healthcare provision quality enhancement as well as the duration of hospitalization and quality of life. 16Precise and coherent data in MDS are used for evaluating the incidence, prevalence, and burden of the disease at both national and international levels. 17MDS development is an important prerequisite to the collection of standards, integrated, and identical data about a disease.MDS provides high-quality information for care providers by creating a national database. 17MDS can be used for collection and standardization of the data.It also eases the sharing and comparing data across various healthcare centers, as well as designing electronic health records of patients. 18In addition, MDS is a valuable source of information in improving patient care 14 and for registry and reporting systems. 19,20e proper selection of data elements is a major reason for the success or failure of registry systems. 20Through precise definitions of data elements, MDS should create a common language among all entities who are involved in registry and recording.In addition, it should guarantee the collection, analysis, reporting, and selection of essential data. 21,22Further, MDS contributes to improving medical history files, data comparability, designing a data corpus, electronic exchange of data across various healthcare systems, and finally improving data quality. 21,23According to the essence and application, the data elements of a disease can be categorized into administrative and clinical data.The administrative data usually include demographic and socioeconomic data, address, telephone number, and patient referral data, besides the main profession of the healthcare providers. 24,25On the other hand, the clinical data differs depending on the type of disease.
Generally, they include diagnosis, past medical history, laboratory results, medical imaging findings, healthcare interventions, disease progression and outcomes. 25 recent years, extensive studies have been done on the MDS in healthcare systems.7][28][29][30][31][32] However, two the best knowledge of authors, there is no specialized or comprehensive registry system for identifying patients with spinal canal stenosis, determining the disease outcome, and examining the effectiveness of its treatment methods.Thus, launching a registry system for spinal canal stenosis provides the possibility of determining the prevalence of the disease, the underlying factors contributing to the incidence of the disease, examining the complications resulting from the disease, exploring the effect of time of initiating the treatment, as well as various therapeutic interventions and the outcomes resulting from the treatment.This study expresses our experiences in the process of developing an MDS which can be useful for subsequent registrations especially in developing countries, which have limited infrastructures on information technology.
This study aims to propose a national MDS for the spinal canal stenosis registry system.However, it can be applied as a model for other regions, especially for developing countries.This data set can cover all influential factors in the health of these patients such as socioeconomic status, personal and familial history, diseasedeveloping conditions, comorbidities, diagnostic and therapeutic interventions, and healthcare outcomes.

| METHODS
The applied study, was conducted descriptively and qualitatively in 2022 in Imam Reza hospital in Kermanshah, the West of Iran in four stages.

| Study design
In the first stage, by studying the records of hospitalized patients diagnosed with spinal canal stenosis, their administrative and clinical data elements were extracted.In this regard, the list of cases was prepared from the hospital information system (HIS) based on the diagnosis code of spinal canal stenosis from ICD-10.The records were extracted from the hospital file system based on the file number.Records were extracted by the study researcher and its data elements.The sources of the study were the files of hospitalized patients diagnosed with spinal canal stenosis (ICD-10 code = M48.0).There were 200 cases with this diagnosis in the 2020−2021 time frame, all of which were studied.
The second stage included identifying data elements for risk factors, aggravating factors and long-term consequences of the disease.Resources for this stage include papers, MDS in other countries, websites and clinical guidelines associated with the vertebral column diseases were investigated.Based on search strategy (Table 1), the relevant resources were extracted from internet based on the inclusion criteria.A comprehensive review of recovered resources was carried out until saturation.

| Data collection
In the stages one and two, data were collected using data extraction form that designed based on previous studies and advice of experts from health information management and neurosurgery.The collected data were first coded, then similar cases were grouped and the duplicate ones were eliminated.Finally, the data elements were categorized as the main group, data classes, data subclass, as well as values and data elements.
In the third stage, the proposed data elements are matched to the national health information systems in the Iran.The data elements were investigated considering the official health information systems such as the Iranian Health Electronic Record System (SEPAS) and Health Integrated System (SIB).The data collection instrument was a checklist, which was designed based on the findings of the first and second stages of the study.The checklist aimed to match the name and values of proposed data elements against the data elements offered in the mentioned systems, as well as to confirm the coding standard used for the data in them.The data collection was done via scrutinizing the mentioned systems and review of the available documents about their content.Based on the findings of previous stages of the study, the initial draft of the MDS of the spinal canal stenosis registry system was proposed.Next, this draft was provided to five experts including two neurosurgeons, two Health Information Management, Health Information Management, and one epidemiologist.After receiving the advices, the intended corrections were made.These corrections included changing the title of some data elements, changing the grouping of data elements, adding three new data elements, and removing two of them.Finally, based on the opinion of experts, a questionnaire was designed to determine MDS in both administrative and clinical departments.The questionnaire included administrative data elements (five classes) and clinical data elements (14 classes).

| Analysis
The Delphi technique was employed for validating the developed MDS model of spinal canal stenosis national registry system.To  3 and 4. The detailed list of classes and subclasses of administrative and clinical data elements in the final model are reported Tables 5 and 6.

| DISCUSSION
In The course of the disease and the response to treatment Evaluation date-the result of evaluating the course of the disease and the process of response to treatment-description of the evaluation/follow-upthe final result of treatment performed Abbreviation: MDS, minimum data set.
injuries, 33 speech therapy, 34 cardiac electrophysiology, 35 patients suffering from pelvic floor disorders, 36 postmortem computed tomography report for anthropological biological profiling, 37 and COVID-19 registry. 18The reason for this classification has been the different nature and application of administrative and clinical data.
The first general group of data included administrative data.These data are usually used for identifying patients, registering the healthcare institute or provider specifications, service costs, and administrative reports. 18ven the applications mentioned in the present study, the administrative data sets for the spinal canal stenosis registry system included five classes capturing demographic data, socioeconomic data, address, healthcare identification data, and patient referral data.
In the class of demographic data, eight data elements had been proposed, all being approved by the experts.The only difference between this class with other similar studies in Iran [16][17][18][19]38 on proposed data elements was the passport number of foreign citizens, due to referral of patients from Iraq and Afghanistan for treating spinal canal stenosis in Iran. Cosidering the importance of registering socioeconomic data in patients with spinal canal stenosis, for the socioeconomic data class, seven data elements were proposed, all being approved by the experts except for ethnicity.
Some of the data proposed in this class had differences from similar studies. 36,38Considering the effect of type of occupation on the severity of disease as well as the patient's response to the treatment, four data elements were considered for describing the patient's job.
Given the wide extent of occupations, for precise determination of the type of job, it was proposed that the job type be chosen based on the official list of Social Welfare Organization Jobs in Iran.
Given the study aim, which was a population registry system, one of the practical data for studying the incidence and prevalence of the disease across different regions was the patient's address.Thus, five data elements had been proposed for the address class, with three of them being approved by the experts.Two of its data including the type of residence and complete address of the patient per each country, province, and so forth had been considered for supporting the epidemiological studies of the disease across different regions.
The data and classification of their values were similar to the MDS of COVID-19 registry 18 and the MDS of the gestational diabetes registry. 14The two next classes of the administrative data set belonged to the healthcare identification data and patient referral data.Overall, nine out of 20 proposed data elements were approved by the experts.These data had been proposed for registering the information of healthcare providers and patient referrals, which were similar to other studies. 14,18,26e second group of data belonged to clinical aspects.A total of 94 data elements had been proposed in 14 classes, with only one remaining unapproved by the experts.The aim of the classification and proposal of data in each class was to provide important information about the disease risk factors, diagnosis, treatment, and evaluation of the treatment response process, and disease outcome.
The first class of clinical data covered the disease signs and symptoms.Since pain is weighed as the most important symptom of the disease, 39,40 a separate subclass and six data elements were considered for the pain evaluation.Apart from the pain-associated data elements, eight data elements were also considered for other common signs and symptoms of the disease.In chronic diseases such as spinal canal stenosis, the severity and number of symptoms and signs of the disease play a key role in selecting the treatment plan and disease outcome determination (such as postoperative assessment). 40Thus, in the registry of vertebral column diseases, a section is dedicated to pain assessment.
In addition to the severity of signs and symptoms of spinal canal stenosis, the extent of disability resulting from the disease is also very important in the treatment plan and evaluation of its effectiveness.In particular, in lumbar spinal stenosis, disability evaluation becomes further important. 40Thus, a special class had been considered for the data elements of the disease disability.The first data element belonged to the Oswestry disability index score.It is used as a routine standard in the evaluation of pain and disability in vertebral column diseases. 41In addition to the Oswestry disability index score, based on the WHO Disability Assessment Schedule (WHODAS), five data elements were proposed for evaluating the limitation in activities and participation.WHODAS is a well-known instrument for evaluating health and disability worldwide. 42Some studies have also shown the effectiveness and validity of this instrument for evaluating the disability resulting from vertebral column diseases. 43In our study, the reason behind proposing the evaluation of disability through WHODAS was the feasibility of patient disability status coding with ICF or V chapter (Supporting Information section for functioning assessment) ICD-11.Ahmadi et al. also in designing the MDS of disability health information management system, had proposed ICF for disability coding. 24The next class belonged to diagnosis, and included six data elements.Considering the WHO schedule for the implementation of ICD-11, as well as its pilot implementation in Iran, 44  However, in the radiology form of the Spine Tango registry, numerous data elements had been considered for registering complete details of the imaging findings. 45r registering the treatment process data in patients with spinal canal stenosis, four data classes of physiotherapy, exercise recommendation and patient education, surgical/invasive procedures, and medication had been proposed.The data proposed in these four classes were similar to the MDS of disability 24 and the MDS of the HIS. 29eatment of spinal canal stenosis depends on the clinical conditions of the patient, undergoing physiotherapy, patient education, exercise, epidural steroid injections, and surgical treatment. 39One of the data elements in these classes was the intended therapeutic intervention code.Use of the code allows for a standard registry of healthcare as well as data exchange between the disease registry information system software and other health information systems such as Electronic Health Record. 46Considering the plan of Iran's Health Ministry for EHR development, 47 a data registry using a standard coding system facilitates data exchange between the information management system of spinal canal stenosis and HER in the future.In the class on surgery and invasive interventions, it was proposed to use ICHI for the coding of interventions.Some studies have shown that ICHI, in comparison to other intervention classification systems, has a better performance in registering the patient's information in the electronic health record. 48r a complete registry of the surgical intervention data, in addition to the surgical/invasive procedures class, a separate class had also been considered for registering the complication surgical procedure.In the international registry of vertebral column Spine Tango, 11 the postoperative complications data elements had been propounded.As the spinal stenosis is most common among the elderly, surgical operation is associated with more risk of unwanted complications. 49Complication surgical procedure was classified in two subclasses of early and late complications.The presence of these data elements can contribute to complete registry of surgical interventions.
The discharge status class has been proposed for registering the information on the treatment outcome in hospitalized patients, including two data elements of discharge data and duration of hospital stay.The duration of hospital stay is a kind of useful data for comparing various surgical techniques and evaluating their outcomes. 50The last data class in the clinical data group belonged to the course of the disease and the response to treatment.The aim of this class was to register the treatment follow-up and response to treatment information.

| CONCLUSION
The MDS proposed in this study is designed to support a attempts were made to set the data elements for registering sufficient details associated with diagnosis, in line with the codes related to spinal canal stenosis and other accompanying disorders.The individual and family medical history included 22 data elements.It had been proposed first for supporting the registry of individual and family risk factor for spinal canal stenosis.The second aim was to register other underlying diseases, which can negatively affect the course or treatment of the disease.In comparison to similar registry systems such as NOR spine12 and Spine Tango, 11 more data elements have been considered for registering the disease risk factors.For example, in Spine Tango, height, weight, and cigarette smoking had been considered as risk factors.11In the clinical data, three classes captured para-clinical diagnostic data elements (medical imaging, clinical laboratory tests, and electromyography).The medical imaging data such as MRI have great value in diagnosing spinal canal stenosis.In our study, five data elements had been proposed for medical imaging, which was similar to other studies conducted in Iran.In our study, the aim of presenting this format for diagnostic data elements such as medical imaging was to facilitate the data collection and registry in a health electronic information system (according to the action code data element).ZAREI ET AL. | 7 of 10 comprehensive registry of administrative and clinical data of patients with spinal canal stenosis.In this MDS, attempts were made to first emphasize the epidemiological aspects of the disease, and provide the possibility of registering and collecting patient data for various research through a clinical approach.Moreover, the possibility of data exchange between the registry information system software and HER is considered, besides using new classification systems such as ICHI.In this regard, two stage of Delphi technique was conducted by the cooperation of 25 experts in various related fields including neurosurgeons and physiotherapist besides the specialists in health information management and medical informatics.The developed model included 120 data elements in two major branches of administrative data and clinical data, each involved 27 and 94 data elements, respectively.The application of this MDS can contribute to establishing a spinal canal stenosis registry system in Iran.It can also provide a higher quality registration of patient information in different healthcare centers.

Table 2 )
Search strategy for retrieving data elements of spinal canal stenosis.row) was set at the end of the data elements related to each class, to allow the experts to add any extra data deemed essential for the registry.For measuring the questionnaire reliability, Cronbach ⍺ coefficient was used.The coefficient was The criterion for selecting a data element in the questionnaire was 75% consensus of experts over that.In the first stage of Delphi decision-making, the data elements with a consensus of less than 50% were removed.Demographic characteristics of participants in the study.Summary of administrative data elements for minimum data set for spinal canal stenosis, underwent the Delphi method. of the Delphi method, a total number of 48 data elements were provided to the experts.Three of the administrative data elements were eliminated and 45 of the elements were approved.The final model included 120 data elements (27 administrative and 94 clinical data elements) which are summarized in Tables Inclusion criteriaLiterature in the English and Farsi language; scientific papers; annual reports; guidelines.Exclusion criteriaNon-peer-reviewed papers, reports, and forms retrieved from personal weblogs; abstracts without accessible full text.Keywords"Spinal canal stenosis data element"; "Data element of Spinal canal stenosis"; "Spinal canal stenosis information management System"; "Minimum Data Set"; "Data Dictionary"; "Registry System or MDS"; "Spinal canal stenosis and Registry System."Abbreviation:MDS, minimum data set.ZAREI ET AL. | 3 of 10 measure the response of items, a five-point Likert scale was used (very much, much, somehow, little, very little).Moreover, one openended question (blank To prepare the desired MDS, two Delphi decision-making stages were done.In the first stage, 135 data elements had been proposed, which included 40 elements for the administrative data and 95 for the clinical branch.In the groups of administrative data, 10 data elements were eliminated out of the 40 proposed ones, due to less than 50% consensus among the experts.The removed data elements were the phone number of patient's place of residence, patient's email, name of the service provider/service registrant, the surname of the service provider/service registrar, the healthcare center affiliation, the relevant medical sciences university, complete address of the healthcare center, the healthcare center email and its postal code.Moreover, 23 data elements related to the administrative data underwent a second opinion in the second stage of the Delphi study due to 50%−75% agreement among the experts.Among the 95 proposed elements for the group of clinical data, only one data element was eliminated, which was the test code.Further, the experts were asked again about 25 data elements, due to 50%−75% agreement over them.The data were related to the medical, individual, and family history of the patient, besides laboratory test, physiotherapy data, exercise recommendation and patient training, data on the disease course and the disease outcome.In the second T A B L E 2 stage the present study, a MDS for spinal canal stenosis has been presented for Iran.It is divided into the administrative and clinical data groups.Most studies on the MDS have also used this classification.The examples include MDSs presented for C-section anesthesia information management system, 16 traumatic brain T A B L E 4 Summary of clinical data elements for minimum data set for spinal canal stenosis, underwent the Delphi method.The data elements in each class and subclass of administrative category for MDS of spinal canal stenosis.The data elements in each class and subclass of clinical category for MDS of spinal canal stenosis. village, region/neighborhood, …), mobile phone number Healthcare identification data ID, healthcare center name, healthcare center type Patient referral data Medical appointment-type of visit-date of data registration-provider's/person's role (system manager, treating physician, consulting physician, referring physician, surgeon, physiotherapist, nurse, radiologist, data quality control officer, patient, patient's accompanying person)-the specialist of the service provider/data recorder, The ID of the service provider/data recorder Abbreviation: MDS, minimum data set.)-code of the underlying disease based on ICD-duration of the disease-is the disease under treatment or not?-Relationship of the underlying disease with spinal canal stenosis-history of trauma to the spinenature of the injury (type of injury and anatomical location)-history of other spine diseases-name of the disease-history of related congenital muscularskeletal abnormalities-family history of spine diseases-proportion of the affected person-history of previous treatment for spinal diseases-type of treatment-exercise-type of exercise (name and weekly average)-smoking and drug or alcohol use-type of substance consumed Medical imaging Date-type of medical imaging (X-rays, MRI, CT scan, CT myelogram)-imaging procedure name-imaging procedure code-diagnosis (impression)