The National Spinal Cord Injury Registry of Iran (NSCIR-IR) is a not-for-profit, hospital-based, and prospective observational registry that appraises the quality of care, long-term outcomes and the personal and psychological burden of traumatic spinal cord injury in Iran. Benchmarking validity in every registry includes rigorous attention to data quality. Data quality assurance is essential for any registry to make sure that correct patients are being enrolled and that the data being collected are valid. We reviewed strengths and weaknesses of the NSCIR-IR while considering the methodological guidelines and recommendations for efficient and rational governance of patient registries. In summary, the steering committee, funded and maintained by the Ministry of Health and Medical Education of Iran, the international collaborations, continued staff training, suitable data quality, and the ethical approval are considered to be the strengths of the registry, while limited human and financial resources, poor interoperability with other health systems, and time-consuming processes are among its main weaknesses. Â© 2019 Chinese Medical Associatio

Azadmanjir, Z.

AzarHomayoun, A.

Benzel, E.C.

Fehlings, M.G.

Ghodsi, Z.

Jazayeri, S.B.

Khormali, M.

Mohammadzadeh, M.

Naghdi, K.

O'Reilly, G.

Pirnejad, H.

Rahimi-Movaghar, V.

Sadeghi-Naini, M.

Sadeghian, F.

Sehat, M.

Sharif-Alhoseini, M.

Vaccaro, A.R.

Zendehdel, K.

English

kashan university of medical sciences

lable at ScienceDirect
Chinese Journal of Traumatology 22 (2019) 300e303Contents lists avaiChinese Journal of Traumatology
journal homepage: http: / /www.elsevier .com/locate/CJTEEShort Communication
National Spinal Cord Injury Registry of Iran (NSCIR-IR) e a critical appraisal of its
strengths and weaknesses
Mahdi Sharif-Alhoseini a, Zahra Azadmanjir b, Mohsen Sadeghi-Naini a, Zahra Ghodsi a,
Khatereh Naghdi a, Mahdi Mohammadzadeh c, Amir AzarHomayoun a, Kazem Zendehdel d,
Moein Khormali a, e, Farideh Sadeghian f, Seyed Behzad Jazayeri a, Mojtaba Sehat c, Habibollah Pirnejad g,
Edward C. Benzel h, Gerard O'Reilly i, Michael G. Fehlings j, Alexander R. Vaccaro k,
Vafa Rahimi-Movaghar a, l, *
a Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences, Tehran, Iran
b Department of Health Information Management, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran
c Trauma Research Center, Kashan University of Medical Sciences, Kashan, Iran
d Cancer Research Center, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran
e Students' Scientiﬁc Research Center, Tehran University of Medical Sciences, Tehran, Iran
f Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran
g Department of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran
h Cleveland Clinic Foundation, Department of Neurosurgery, Cleveland, OH, USA
i Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
j Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada
k Department of Orthopaedic Surgery, The Rothman Institute, Thomas Jefferson University, Philadelphia, USA
l Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Irana r t i c l e i n f o
Article history:
Received 7 January 2019
Received in revised form
19 May 2019
Accepted 5 June 2019
Available online 13 July 2019
Keywords:
Spinal cord injuries
Injury registries
Data accuracy
Iran* Corresponding author. Sina Trauma and Surgery R
Hassan-Abad Square, Imam Khomeini Ave, Tehran, 11
E-mail addresses: v_rahimi@tums.ac.ir, v_rahim
Movaghar).
Peer review under responsibility of Chinese Medi
https://doi.org/10.1016/j.cjtee.2019.05.003
1008-1275/© 2019 Chinese Medical Association. Pr
creativecommons.org/licenses/by-nc-nd/4.0/).a b s t r a c t
The National Spinal Cord Injury Registry of Iran (NSCIR-IR) is a not-for-proﬁt, hospital-based, and pro-
spective observational registry that appraises the quality of care, long-term outcomes and the personal
and psychological burden of traumatic spinal cord injury in Iran. Benchmarking validity in every registry
includes rigorous attention to data quality. Data quality assurance is essential for any registry to make
sure that correct patients are being enrolled and that the data being collected are valid. We reviewed
strengths and weaknesses of the NSCIR-IR while considering the methodological guidelines and rec-
ommendations for efﬁcient and rational governance of patient registries. In summary, the steering
committee, funded and maintained by the Ministry of Health and Medical Education of Iran, the inter-
national collaborations, continued staff training, suitable data quality, and the ethical approval are
considered to be the strengths of the registry, while limited human and ﬁnancial resources, poor
interoperability with other health systems, and time-consuming processes are among its main
weaknesses.
© 2019 Chinese Medical Association. Production and hosting by Elsevier B.V. This is an open access article
under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Introduction
The National Spinal Cord Injury Registry of Iran (NSCIR-IR) is a
not-for-proﬁt, hospital-based, and prospective observational reg-
istry of individuals who sustained a traumatic spinal cord injuryesearch Center, Sina Hospital,
365-3876, Iran.
i@yahoo.com (V. Rahimi-
cal Association.
oduction and hosting by Elsevie(SCI). It is funded and sustained by the Ministry of Health and
Medical Education of Iran (MOHME).1 The NSCIR-IR appraises the
quality of care, long-term outcomes and the personal and psycho-
logical burden of traumatic SCI in Iran based on the patients' hos-
pitalizations. The long-term follow-up involves patients' re-
hospitalization due to the complications of spinal fracture and
SCI. Therefore NSCIR-IR is a research infrastructure for developing
and preparing related research projects. There are some ongoing
studies using the registry data.
The NSCIR-IR has been implemented in eight university trauma
centers, including Sina Hospital (Tehran University of Medicalr B.V. This is an open access article under the CC BY-NC-ND license (http://
M. Sharif-Alhoseini et al. / Chinese Journal of Traumatology 22 (2019) 300e303 301Sciences), Firoozgar Hospital (Iran University of Medical Sciences),
Poursina Hospital (Guilan University of Medical Sciences), Shahid
Beheshti Hospital (Kashan University of Medical Sciences), Emam
Khomeini Hospital (Urmia University of Medical Sciences), Shahid
Rahnemoon Hospital (Yazd Shahid Sadoughi University of Medical
Sciences), Emam Reza (Tabriz University of Medical Sciences), and
Emam Hossein (Shahrood University of Medical Sciences) (Fig. 1).
Although the NSCIR-IR is not a population-based study registry, it is
ready to expand to the other cities of the country. The registry
administrators are providing the technical infrastructure and
educational needs for universities that want to participate in the
registry. Fig. 2 shows the schematic process of the NSCIR-IR.
Benchmarking validity in every trauma center registry involves
rigorous attention to data quality.2 We reviewed the strengths and
weaknesses of the NSCIR-IR while considering the methodological
guidelines and recommendations for efﬁcient and rational gover-
nance of patient registries.3
A high-quality data registry should address four key dimensions,
including “governance”, “data quality”, “information”, and “ethical
issues, security, and privacy”.3
Governance
Broadly speaking, a governing body establishes a framework for
the registry, assists with its implantation, and assures the quality of
the registry. Speciﬁc elements pertaining to governance are
reviewed below.
Procedures and methods
Although the steering committee of the NSCIR-IR has outlined
basic strategies, the purpose and procedures of the registry must be
clearly established. Also, the application of digital technology can
help lower costs, improve data quality, and help monitor staff's
performance.
Education
The registry staffs are all dedicated nurses who have been
trained on the patient registry protocol and procedures in additionFig. 1. Collaborative university centers of theNational Spinal Cord Injury Registryof Iran.to being educated on the American Spinal Injury Association (ASIA)
impairment scale, international standards for classiﬁcation of SCI,
the AOSpine Fracture Classiﬁcation System, and the World Health
Organization Quality of Life-BREF assessment. Periodic retraining is
essential for maintaining and developing updated skills to better
manage the registry. The development of online learning tools and
certiﬁcation programs has made the process of retraining staff
more feasible.
Resource planning and ﬁnancial sustainability
The NSCIR-IR has a single director, an executive manager, 9-11
dedicated and educated registrars, and at least four data collectors,
as part of multi-hospital registry.3 However, some collaborating
centers could beneﬁt from allocating a facility solely for data reg-
istry. In addition, available resources must be allocated directly to
the development and upkeep of the registry. Given the limited
ﬁnancial and human resources available to the MOHME, the use of
such resources must be managed efﬁciently by an executive man-
ager. The steering committee should also plan ahead in order to
have future resources available and ensure the sustainability of the
registry. International organizations, such as the World Health Or-
ganization, AO Foundation, nursing or rehabilitation agencies,
medical devices industries, and insurance companies can be valu-
able assets as sponsors of the registry.
Interoperability
The integration of outside partnerships is another key element
that assists with the exchange of information. For example, a large
international workgroup contributed to the creation of the frame-
work of NSCIR-IR.1 Also, a representative of the Spinal Cord Injury
Association of Tehran (a non-governmental organization) partici-
pates as an advisory member in the strategic workgroup. The pre-
hospital data, injury mechanism, demographic data, diagnosis, and
in-hospital procedures are extracted from the hospital information
system. Initial steps are being taken to share the database with the
Statistics and Information Technology Ofﬁce of theMOHME and the
National Trauma Registry of Iran. Data exchange between the
NSCIR-IR and National Trauma Registry of Iran can be helpful to
avoid duplication of data entry on pre-hospital care. Additionally,
integrating acute care and rehabilitation facilities as well as local
and national survival and death census bureaus are also crucial.
Self-assessment
Self-assessment is a responsibility of the governance to ensure
that the quality of data is appropriate and the functional oversight
of the registry is in place.3 For instance, the case identiﬁcation rate
was one of the lowest results in the NSCIR-IR during a pilot study
(70.8%)1 whichmight be due to amisunderstanding of the inclusion
and exclusion criteria. Such a shortcoming could be addressed
through training webinars and local review seminars. Likewise,
missing data should be regularly reported and handled with the
appropriate oversight. Also, each data point that meets the purpose
and goals of the registry should be included in the registry by the
steering committee.3 For instance, while the timing of presentation
to an acute care setting is considered in the present registry, it
would be beneﬁcial to also incorporate the corresponding surgical
procedure.
Data quality
In order to ensure that high-quality data are obtained, seven
important elements need to be reviewed.4
Fig. 2. Schematic process of the National Spinal Cord Injury Registry of Iran.
*Electronic Health Record System, Statistic and Information Technology Ofﬁce of Ministry of Health and Medical Education, Iran. SCI: spinal cord injury.
M. Sharif-Alhoseini et al. / Chinese Journal of Traumatology 22 (2019) 300e303302Completeness
In the NSCIR-IR, trained and dedicated registrars input all the
appropriate data, while reviewers verify that all the available data
have been indeed registered. Moore and Clark5 reported that some
of the most important data items in the registry were not recorded
in the patients' medical records. The NSCIR-IR's registrars attempt
to resolve this issue by communicating with treating physicians,
nurses, patients, or family relatives to obtain the missing data.Accuracy and precision
In order to ensure accuracy and precision, data should be
gathered in a reliable manner and directly from the source.2 In
the current registry, injury characteristics as well as pre-hospital
and emergency department information are directly collected
through patient interviews and medical records, while the
neurological exam is re-examined by trained registrars. Also,
diagnostic imaging and fracture classiﬁcation are assessed by
registrars and reviewers, but still some diagnostic and thera-
peutic data are extracted from the hospital information system
administrative database. Therefore, care providers play a vital
role in the accuracy and precision of data by ensuring the validity
of the data entry and the appropriate use of International Clas-
siﬁcation of Diseases (ICD) codes. The use of the existing data-
bases could have both pros and cons. With decreasing cost and
eliminating duplicate work by sharing the database, use of theexisting databases might compromise the control and monitor of
the data accuracy. Phillips et al4 showed that the accuracy of
different databases (e.g. an administrative database or a registry)
was affected by the different purposes of each database. In the
future, the inter-rater reliability between registrars should be
measured to ensure the accuracy of the registry. Likewise,
providing continuing education and training courses for physi-
cians and medical coders are advisable.Correctness
Data correctness is the process of identifying and correcting
data inconsistencies. In NSCIR-IR, a smart web-based system is
used to automatically reject incorrect values or values that are
outside the range, while generating some computations for nu-
merical data.Consistency
Data consistency is the process of maintaining uniform data
values in an application. Deﬁned rules and constraints have been
implemented into the web-based registry software to recognize
inconsistent data that falls outside the established rules, especially
numerical inconsistencies. Afterwards, trained neurosurgeon
reviewers carefully examine the submitted data for clinical
inconsistencies.
M. Sharif-Alhoseini et al. / Chinese Journal of Traumatology 22 (2019) 300e303 303Compatibility
The aggregation of data from various sources emphasizes the
need to collect data in a consistent manner so that the different
data types are congruent. For example, there are 285 data elements
in the data set, including 163 elements from the ASIA impairment
scale and international standards for the classiﬁcation of SCI.
Furthermore, diagnostic images (X-Ray, CT scan, and MRI) are
assessed to determine injury morphology based on the AOSpine
fracture classiﬁcation system. Besides, the validated Persian version
of the World Health Organization Quality of Life-BREF question-
naire was used for quality of life assessment.1 The data from each
source must be compatible with the other in order to efﬁciently use
the available data.
Timeliness
Maintaining data in the registry which is up to date is an
important challenge. Timeliness can be measured as the time be-
tweenwhen data are released andwhen they are accessible.6 In the
NSCIR-IR, the registry has become timelier following the transition
to electronic data collection and software promotion. However, due
to the various sectors that patients' ﬁles are referred to, tracking
ﬁles is often difﬁcult. Revisiting medical records to ﬁnd and correct
the defects by reviewers is another time-consuming problem.
Information
Information is an output of the entire data gathering process.3
Its quality can be measured based on the purpose of the registry
(scientiﬁc publications, outcomes, and surveillance), which can
ultimately control the methodological basics and ensure quality
data. For instance, information from surveillance registry can be
used to improve facilities treatment protocols. So far, the NSCIR-IR
has not produced such information and should actively pursue this
following sufﬁcient data gathering.
Ethical issues, security, and privacy
This dimension is concerned with the secure use of patient
health information.3 The Ethics Committee of the Sina Trauma and
Surgery Research Center, Tehran University of Medical Sciences,
reviewed the security and privacy protocol of the registry leading to
its approval.1 Likewise, researchers should be trained and required
to sign a statement indicating an understanding of their re-
sponsibility in maintaining conﬁdentiality of patient health infor-
mation while accessing it. In the NSCIR-IR, several safeguards have
been set in place to protect patient health information during the
collection, storage, back-up, and access to the data. In order to
improve the security of the data, an encrypted block chain-based
cloud storage network can be implemented in future designs.Data quality assurance is essential for any registry to make sure
that correct patients have been enrolled and the collected data are
valid. In the NSCIR-IR, retraining the registrars could improve case
identiﬁcation rate, accuracy, consistency, and timeliness of the
registry. The processing and correction of data should be facilitated
by registrars, reviewers, and care providers. Regular self-
assessment of governance, close supervision and monitoring of all
collaborating centers are equally essential. Improving the quality of
data by critically and continuously reviewing these elements will
allow a more efﬁcient registry.6
Summary
While the steering committee, funded and maintained by the
MOHME, the international collaborations, continued staff training,
suitable data quality, and the ethical approval are considered to be
the strengths of the NSCIR-IR; while the weaknesses include
limited human and ﬁnancial resources, poor interoperability
among health systems, and time-consuming processes.
Funding
This study was supported by a grant number 36913 from Sina
Trauma and Surgery Research Center, Tehran University of Medical
Sciences, Tehran, Iran.
Ethical statement
Patient health information has been secured. The local ethics
committee reviewed the security and privacy protocol of the reg-
istry and thereafter approved the study.
Conﬂicts of interest
The authors declare no conﬂicts of interest.
References
1. Naghdi K, Azadmanjir Z, Saadat S, et al. Feasibility and data quality of the na-
tional spinal cord injury registry of Iran (NSCIR-IR): a pilot study. Arch Iran Med.
2017;20:494e502.
2. O'Reilly GM, Gabbe B, Moore L, et al. Classifying, measuring and improving the
quality of data in trauma registries: a review of the literature. Injury. 2016;47:
559e567. https://doi.org/10.1016/j.injury.2016.01.007.
3. Zaletel M, Kralj M. Methodological Guidelines and Recommendations for Efﬁcient
and Rational Governance of Patient Registries. ﬁrst ed. Ljubljana, Slovenia: Na-
tional Institute of Public Health; 2015.
4. Phillips B, Clark DE, Nathens AB, et al. Comparison of injury patient information
from hospitals with records in both the national trauma data bank and the
nationwide inpatient sample. J Trauma Acute Care Surg. 2008;64:768e780.
https://doi.org/10.1097/TA.0b013e3181620152.
5. Moore L, Clark DE. The value of trauma registries. Injury. 2008;39:686e695.
https://doi.org/10.1016/j.injury.2008.02.023.
6. Porgo TV, Moore L, Tardif PA. Evidence of data quality in trauma registries: a
systematic review. J Trauma Acute Care Surg. 2016;80:648e658. https://doi.org/
10.1097/TA.0000000000000970.


National Spinal Cord Injury Registry of Iran (NSCIR-IR) â�� a critical appraisal of its strengths and weaknesses

http://eprints.kaums.ac.ir/4441/1/1-s2.0-S1008127519300045-main.pdf

National Spinal Cord Injury Registry of Iran (NSCIR-IR) â�� a critical appraisal of its strengths and weaknesses

Abstract

Similar works

Full text

Available Versions

kashan university of medical sciences