|Year : 2022 | Volume
| Issue : 2 | Page : 163-169
IndiCleft – A web-based standardized research tool and resource for cleft anomalies
OP Kharbanda1, Ashoo Grover2, Savita Dawar3, Karoon Aggarwal4, SC Sharma5, Maneesh Singhal6, Shashank Chauhan6, Harpreet Singh7, Madhulika Kabra8, Neeraja Gupta8, Vinod Scaria9, MriduPobon Rajkhowa10, ArtiGarg10, Nitika Monga7, Ravinder Singh7, RS Dhaliwal11
1 Ex-Chief, CDER, AIIMS, New Delhi, India
2 Scientist F, ICMR, New Delhi, India
3 Ex-Scientist, NIC, New Delhi, India
4 Plastic Surgery, NHI, New Delhi, India
5 Ex-Head, ENT Deptt., AIIMS, New Delhi, India
6 Plastic Surgery, AIIMS, New Delhi, India
7 Scientist, ICMR, New Delhi, India
8 Paediatrics, AIIMS, New Delhi, India
9 Scientist, IGIB, ICMR, New Delhi, India
10 NIC, ICMR, New Delhi, India
11 Head, NCD, ICMR, New Delhi, India
|Date of Submission||17-Mar-2022|
|Date of Acceptance||16-Apr-2022|
|Date of Web Publication||23-Aug-2022|
Dr. Ashoo Grover
Scientist 'F' (Deputy Director General Sr. Grade) Indian Council of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar New Delhi 110029
Source of Support: None, Conflict of Interest: None
Introduction: In India, approximately 35,000 new cleft patients are born every year. Many patients receive suboptimum, improper, little, or no treatment. The cumulative burden of cleft care is up to 1 million cases. The spectrum of problems is varied, the caseload is enormous, and the logistics of treatment delivery are complicated. The Indian Council of Medical Research (ICMR) task force project was launched in 2012 to evaluate the status of cleft care in India and develop strategies to provide comprehensive cleft care through a dynamic multidisciplinary and multidimensional tool. ICMR task force project (2012–14) was conducted in Delhi, and the National Capital Region reported that at least 50% of studied cases had complex and multiple treatment needs. The needs identified were related to surgical, orthodontic, dental, ENT and Speech, rehabilitation of mutilated dentition, and various psychological disturbances among patients with Cleft anomalies. Aim: The aim of this study was to develop and test web-based application to create a system for national data of patients with cleft anomalies and digitize the patient records in a standardized preagreed format. Methods and Results: Corresponding to contemporary digital technologies and evolutionary improvements in data collection, web-based data collection instrument, including text, photographs, X-rays, and audio files, was considered the most appropriate. The experts from varied domains in consultation with ICMR and National Informatics Centre evolved a web-based data collection instrument which is named the “IndiCleft tool.” The tool has been tested and used over the years and is presently being upgraded to dynamic version for a national data and patient care registry. Conclusion: The present article describes the process of the development of a “dynamic” web-based data collection instrument. The IndiCleft tool is the national resource on cleft data in India.
Keywords: Cleft lip and palate, IndiCleft, web-based tool
|How to cite this article:|
Kharbanda O P, Grover A, Dawar S, Aggarwal K, Sharma S C, Singhal M, Chauhan S, Singh H, Kabra M, Gupta N, Scaria V, Rajkhowa M, ArtiGarg, Monga N, Singh R, Dhaliwal R S. IndiCleft – A web-based standardized research tool and resource for cleft anomalies. J Cleft Lip Palate Craniofac Anomal 2022;9:163-9
|How to cite this URL:|
Kharbanda O P, Grover A, Dawar S, Aggarwal K, Sharma S C, Singhal M, Chauhan S, Singh H, Kabra M, Gupta N, Scaria V, Rajkhowa M, ArtiGarg, Monga N, Singh R, Dhaliwal R S. IndiCleft – A web-based standardized research tool and resource for cleft anomalies. J Cleft Lip Palate Craniofac Anomal [serial online] 2022 [cited 2022 Dec 8];9:163-9. Available from: https://www.jclpca.org/text.asp?2022/9/2/163/354296
| Introduction|| |
In India, approximately 35, 000 new patients with cleft are born every year. Many patients have received suboptimum, improper, little, or no treatment, and the cumulative burden of interdisciplinary treatment is up to 1 million cases. The spectrum of problems is varied; the caseload is enormous, and the logistics of treatment delivery are complicated. ICMR task force project (2012–2014) was conducted in Delhi, and National Capital Region reported that at least 50% of studies cases had complex and multiple treatment needs. The needs identified were related to surgical, orthodontic, dental, ENT and Speech, rehabilitation of mutilated dentition, and various psychological disturbances among patients with Cleft anomalies. Every cleft child has the right to have optimum quality treatment, care, and support services. To provide the same, the evidence for newer updated knowledge has to be generated through research.
There is a high burden of care in cleft anomalies as it demands an interdisciplinary approach, multiple surgeries/interventions, and long-term follow-up. Because of the above factors of cleft management, it becomes imperative to collect data in a standardized and cohesive manner from government and private facilities providing cleft care. To fulfill the above objectives of the IndiCleft project, the first and foremost task appeared to generate a consensus on data items that will bring us a piece of logistical information on cleft etiology, current treatment and practices, treatment outcomes, and possible solutions. This enormous data of every cleft child have to be captured and managed from participating centers across India. Corresponding to contemporary digital technologies, there have been evolutionary improvements in data collection. The development of a web-based data collection instrument, which includes text and pictures and audio files, is preferred and considered most appropriate. The Indian Council of Medical Research (ICMR), New Delhi, a premier research body of the Government of India in collaboration with Center for Dental Education and Research (CDER), All India Institute of Medical Sciences, New Delhi, in consultation with subject experts, and the National Informatics Centre (NIC), evolved a web-based data collection instrument which is named “IndiCleft tool.”
This web-based application is hosted on the ICMR website. Using the IndiCleft tool, various institutions, organizations, and facilities engaged in the management of patients with cleft anomalies can upload their data through selective participation.
The present article describes the process in the development of “dynamic” web-based data collection instrument IndiCleft. The word “dynamic” has been used to describe an evolutionary process through various versions of drafting the instrument, namely IndiCleft. The article presents the instrument, components, data management techniques, and methods to analyze/interpret those.
Objective of developing the tool
The objective of developing the IndiCleft – a web-based application, was to create a system to have a database of patients with cleft across high volume centers in India. The information in the web application can be readily tabulated, is dynamic, and easily accessible. This data generated through tool will make the basis of future research for researchers/academicians and also policy decisions by relevant stakeholders. It is also expected to develop a user-friendly web based tool for clinicians and other health staff engaged in management of patients with cleft anomaly.
Process of developing the tool
It has been undertaken in steps approach in a phased manner through the participation of experts from different disciplines [Figure 1].
- Drafting offline tool: ICMR initiated inter-center collaborative research in collaboration with the Department of Orthodontics, CDER, AIIMS, New Delhi, one of the premier health-care institutions in India, in a task force mode to identify risk factors of cleft anomalies and treatment needs of patients with cleft in three Delhi-based centers. An offline article-based questionnaire was developed by ICMR in collaboration with CDER, AIIMS, wherein the basic information as collected in routine was included
- Consultation with multidisciplinary experts: A team of experts from different specialties was constituted to provide consultation in different components of the IndiCleft tool. A total of 42 experts from 13 specialties of various institutions were part of developing this important multidimensional, multifaceted, and dynamic web-based data collection tool of IndiCleft [Table 1]. These experts had several rounds of discussion, who used to meet every quarterly in a year for consecutive 3–4 years to suggest any modifications, understand its dynamicity, feasibility, the scope of expansion, etc., Each section of the performa (tool) has been led by subject expert and has been color coded on the web page [Table 2]
- Testing of tool: The IndiCleft tool, yet at paper-based phase, was tested at three centers: two government cleft care facilities and one private health-care facility, but engaged in cleft care management. It was important to involve the private setup to prevent information bias that may originate if only government-based hospitals were included in the study. The hospitals were chosen based on (1) high volume centers in relation to patients with cleft, (2) availability of necessary minimum infrastructure to provide interdisciplinary care to patients with cleft, and (3) catering to different aspects of cleft care to collect a broad age group
- Validation of tool: To validate the tool, the above mentioned centers were involved in capturing the data in three phases [Table 3], and suitable modifications were done as per the experts' opinion & experiences. The schematic representation of the process is at [Figure 1].
|Table 1: Multidisciplinary team associated with IndiCleft tool development|
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|Table 3: Center-wise number of cases who tested this tool in three phases|
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Components of the tool
The IndiCleft tool is a comprehensive tool to capture the relevant details pertaining to patients with cleft. It starts from general assessment, risk factors assessment, examination of cleft, feeding advice, primary and secondary cleft repair, orthodontic history/repair, ENT assessment, speech and audiology assessment, psychological assessment, and genetic assessment [Figure 2].
Description of the tool
The IndiCleft tool is a web-based application and is accessible from both desktops and tablets. Data collection and image uploading can be done from both desktops and tablets, but image viewing/analysis is done from the NIC application, which runs only on desktops/laptops. Initially, provision for data collection would only be in online mode, but offline mode would be provided consequently. In offline mode, the user can store some limited data in the client and push it to the IndiCleft server. Images are stored in the image repository in NIC Cloud, where the IndiCleft application will be deployed. If we assume 30 images of size 5 MB each for each patient and 50 MB of related data, then the total memory needed for each patient is about 200 MB. Hence, for 10,000 patients, we need at least 2000 GB of storage space. Hence, it requires servers with high storage space.
System testing and logistic
There had been an extensive review of the system. Initially, article-based forms were filled to assess its completeness of all aspects of cleft, followed by each response entered independently to a computer. Computerized data were compared to what was recorded on article for accuracy and completeness. A handbook was also developed to ensure that all possible responses that had to be intended are there in the software.
To ensure the security of the data, it passed through the network, a standard security protocol (SSL/HTTPS) for connecting to our questionnaire from the cleft care center was developed. A server security certificate was configured on the server. This certificate can be created using the default utilities that are part of the Microsoft IIS server environment or one that is purchased from a commercial vendor.
Viewing the questionnaire results
As the data are entered, the results can be directly visualized into the desired format of graphical representation as well in a tabular form. The reports are generated dynamically by combining questionnaires and data outcomes.
Displaying/editing the questionnaire
Implications of IndiCleft versus other tools across the globe
There are global experiences available to capture the data related to the pattern of cleft anomalies, type of repair/surgeries, whether multidisciplinary care or not, treatment outcome, follow-ups, etc. EuroCleft study has been done in Northern Europe since a decade ago and is a longitudinal cohort study. The data on various parameters have been collected such as numbers of surgeries and outpatient visits, several visits, treatment duration for early orthopedics and orthodontic treatment, and associated travel time and difficulties. In this study, the offline data were collected through questionnaire and later were entered into analytical software for interpretation. It was a five-centre study, where children were recruited at the age of 9 years and followed up at up to the age of 12–17 years to study the outcome parameters as mentioned above. One of the major conclusions from this study has been that the measurement of clinical outcomes in childhood is an important and valid form of clinical audit. Multicentric/intercenter studies are more informative than single-center reports and have an important future role in cleft care.
The Americleft, study is a North American initiative to undertake an intercenter outcome study for patients with repaired complete unilateral cleft lip and palate from five well-established North American cleft centers. It has a retrospective cohort study design which was implemented in five cleft palate centers in North America. The age group studied is 6–12 years. Some of the outcomes studied are craniofacial morphologic cephalometric assessment, sagittal maxillary prominence, and other maxillary outcomes. In this study, a questionnaire-based approach has been undertaken, which later on put up on software for analysis purposes.
IndiCleft study undertaken by ICMR, Government of India has been unique in a sense that it encompasses a pragmatic approach at the beginning itself and has been initiated with a short-term and long-term objectives. It is implemented in a phased manner: prepilot, pilot, and main phase, which itself sets a stage for the long-term objective of creating a National Registry. The parameters studied in Eurocleft and Americleft have been incorporated along with specific behavioral, genetic, and psychosocial components. Over and above, the unique feature of IndiCleft is prospective online data capturing across cleft care centers in India and online analysis/interpretation of data, which is going to be directive for policy formulation. The tool has been launched, and is available for further use.
IndiCleft tool is one of the comprehensive tools online and has been as detailed as possible. It is dynamic in nature and is easy to capture the data with preliminary training. IndiCleft has a scope of being integrated with the Government Of India, Rashtriya Bal Swasthya Karyakarm (RBSK). (https://rbsk.gov.in/RBSKLive/). RBSK is the Ministry of Health and Family Welfare; RBSK is the national program in Ministry of Health and Family Welfare; Government of India. It's an innovative and ambitious initiative which envisages Child Health Screening and Early Intervention Services in a systemic way for early identification and link to care, support, and treatment of needy children. Cleft anomalies and other facial deformities are inbuilt components of the program. IndiCleft tool of ICMR will be one of the promising international tools in the area of cleft anomalies research.
The authors would like to acknowledge and express thanks to task force expert group members Dr. Anil Kohli, Dr. P N Awasthi, Dr. Ashok Utraja, Dr. T Samraj, DrMukunda Reddy, Dr. Bonthaya Krishnamurthy, Dr. Jyotsna Murthy, Dr. Vimal Arora, Dr. S G Damle, Dr. Alok Thakker, Dr. S R Savithri, Dr. I C Verma, Dr. Ritushree Kukreti, Dr. Manu Mehta, Dr. Rajesh Sagar, Dr. R M Pandey, Dr. G S Meena, and Dr. J S Thakur. The authors would also like to express special thanks for the constant support of ICMR officials DrBela Shah, Dr. V M Katoch, Dr. S Swaminathan, Dr. R S Dhaliwal, Dr. D K Shukla, Dr. Geetha Menon, Dr. Ravinder Singh, and Dr. Harpreet Singh. Special mention is needed for site investigators Dr. Vilas Samrit, Dr A K Singh. Dr. Hiteswar Sarma, Dr. Srinivas Gosla Reddy, Dr. Shyam Seth, Dr. Sushma Sagar, Dr. Shashank Chauhan, Dr. Neeraj Wadhawan, Dr. R K Khajanchi, and other site investigators. In addition, further acknowledgment is needed for the patients with cleft, their parents, and families who shared with the authors their personal and often protracted experiences of the case. The study team would also like to express thanks for the support of leaders from NIC and MOHFW, who provided advisory support and guidance to the authors.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]