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Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018



Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018



Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018



Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018



Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018



Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata



Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018



Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018



Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018



Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011



Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2024 | Month : May | Volume : 18 | Issue : 5 | Page : ZC30 - ZC35 Full Version

Evaluation of Quality of Life of Parents and Growth Parameters of their Infants with Cleft Lip and Cleft Palate before and after Primary Surgery: An Observational Study

Published: May 1, 2024 | DOI: https://doi.org/10.7860/JCDR/2024/67324.19410

Nupur Saha, Shabnam Zahir, Siddhartha Chatterjee, Arnab Santra, Mainak Das

1. Final Year Postgraduate Student, Department of Paediatric and Preventive Dentistry, Gurunanak Institute of Dental Science and Research, Kolkata, Barasat, West Bengal, India. 2. Professor and Head, Department of Paediatric and Preventive Dentistry, Gurunanak Institute of Dental Science and Research, Kolkata, West Bengal, India. 3. Chief Surgeon, Department of OMFS, ABMSS Cleft Care Centre, Kolkata, Barasat, West Bengal, India. 4. Dental Surgeon, DEIC Under NHM, Department of Paediatric and Preventive Dentistry, Gurunanak Institute of Dental Science and Research, Kolkata, Barasat, West Bengal, India. 5. Second Year Postgraduate Student, Department of Paediatric and Preventive Dentistry, Gurunanak Institute of Dental Science and Research, Kolkata, Barasat, West Bengal, India.

Correspondence Address :
Nupur Saha,
1/1 Pannajhil, Barasat, North 24 Pgs. P.O-Noapara, Barasat-711401, West Bengal, India.
E-mail: drnupursahadas@gmail.com

Abstract

Introduction: Cleft Lip (CL) and Cleft Palate (CP) are associated with several complications that have a significant negative impact on the Quality of Life (QoL) of affected children and caregivers. Compared to their healthy counterparts, children with these conditions experience feeding difficulties, cosmetic abnormalities, and, most importantly, diminished physical and cognitive growth, especially during the first year of their lives.

Aim: To evaluate the growth parameters in CL and/or CP infants and the QoL of parents with a CL and/or CP child before and after primary surgery.

Materials and Methods: For this observational study, data was collected longitudinally from the same set of Cleft lip and cleft palate (CL/CP)/CL&CP infants and their parents before and after the primary surgery. The study was conducted at the Department of Paediatric and Preventive Dentistry, Guru Nanak Institute of Dental Sciences and Research, West Bengal, ABMSS Kolkata Comprehensive Cleft Care Centre, West Bengal, and IMA Vaccination Centre Barasat, West Bengal, India, from December 2020 to May 2022. In this study, 66 children and 64 parents were included in each study and control group. Growth parameters {weight, length, Head Circumference (HC)} were measured using a weight analogue machine, infantometer, and HC measuring tape, and compared with those of healthy infants. The QoL of parents with CL and/or CP infants was quantified using a questionnaire form of “Revised Impact on Family Scale (RIOFS)” filled out by parents before and after six months of primary surgery and compared with the QoL of same-age healthy infants. The responses to the RIOFS questionnaire were scored according to recommended guidelines. The Statistical Package for Social Sciences (SPSS) Statistics 23.0 was used for data analysis.

Results: Among the study groups, statistically significant differences in mean height, weight, and HC were observed between the groups of all infants with CL, CP, and CL with CP before and after the primary surgery (p<0.001). The QoL of parents from the study group improved post-surgery. The difference in mean RIOFS score between study Group-3 and study Group-4 after the primary surgery was statistically significant (p<0.001).

Conclusion: The growth of CL and/or CP infants and the QoL of their caregivers are compromised compared to healthy infants. After primary surgery, the growth of CL and/or CP infants and the QoL of their parents partially improved.

Keywords

Head circumference, Infantometer, Paediatric dentistry, Questionnaire

Introduction
The CL/CP and CL&CP are the most common congenital craniofacial malformations characterised by complete or partial clefts of the lip and/or palate. According to Global Burden of Disease (GBD) 2016 data, the estimated incidence of CL&CP in India is around 0.25 to 2.29 per 1000 births, with a calculated prevalence rate of 33.27 for males and 31.01 for females per 100,000 population (1). The condition has a multifactorial aetiology, where the interaction between environmental and genetic factors plays a key role (2). Numerous issues linked to CL and CP have a considerable detrimental effect on the QoL for parents or caregivers. When compared with their healthy counterparts, children with these conditions experience reduced physical and cognitive growth (3),(4). Proper treatment in a timely manner is required to improve QoL and lead a socially acceptable life; however, many patients receive sub-optimal, limited, or no treatment at all (5). Primary surgery (primary lip surgery at 3-6 months and primary palate surgery at 6-12 months) may improve facial symmetry and functional activity in CL/CP/CL&CP patients, thus enhancing the physical growth of infants and ultimately the QoL of their parents (6),(7).

Studies have been conducted on the effect of CL with or without CP (CL&CP) on Oral Health-Related Quality of Life (OHR-QoL) or Health-Related Quality of Life (HR-QoL) among children (8),(9),(10),(11),(12). However, only a limited amount of literature (3),(13) in this field explores the comparison of the QoL of parents with children with CL, CP, or both CL&CP with their healthy counterparts after primary surgery.

Against this backdrop, the current study aims to comparatively assess the QoL of parents and the growth parameters of their infants with CL, CP, or both CL&CP before and after primary surgery.
Material and Methods
An observational study was conducted at ABMSS Cleft Care Centre, Kolkata, Guru Nanak Institute of Dental Sciences and Research, and IMA Vaccination Centre, Barasat, West Bengal, India. The study period was from December 2020 to May 2022. Ethical clearance was obtained from the institute (Ref No. GNIDSR/IEC/20-23/04), and informed consent was obtained from the parents of the children. Data was collected longitudinally from the same set of CL/CP/CL&CP infants and their parents before and after the infants’ primary surgery.

Inclusion criteria:

- For study Group-1: Infants with CL/CP/CL&CP of both sexes aged 3-6 months, admitted to the above-mentioned hospitals before primary surgery.
- For control Group-1: Age and sex-matched healthy infants aged 3-6 months (According to the World Health Organisation (WHO) Child Growth Standards, 2006) (14).
- For study Group-2: The same infants (9-12 months of age) included in study Group-1 (with CL/CP/CL&CP of both sexes) after six months of primary surgery.
- For control Group-2: Age and sex-matched healthy infants aged 9-12 months (According to the WHO Child Growth Standards, 2006).
- For study Group-3: Either of the parents of 3-6 months infants with CL/CP/CL&CP (study Group-1) admitted to the same hospital before primary surgery.
- For control Group-3: Either of the parents of healthy infants between 3 to 6 months of age (control Group-1), and sex-matched.
- For study Group-4: Either of the parents (parents of the study Group-2) of 9-12 months infants of both sexes with CL/CP/CL&CP after 6 months of primary surgery.
- For control Group-4: Either of the parents of healthy infants between 9 to 12 months (parents of the control Group-2) of age, and sex-matched.

Exclusion criteria:

- For study Group-1 and 2: Infants with CL/CP/CL&CP associated with different syndromes and chronic systemic diseases like cerebral palsy, cardiac problems, etc.
- For control Group-3 and 4: Parents who have infants 3-12 months of age with different syndromes like Down Syndrome, Fragile X Syndrome, and parents who have infants 3-12 months of age with different congenital systemic diseases like thalassemia, congenital cardiac diseases, Cerebral palsy, etc.

Sample size calculation: The sample size was calculated using GPower 3.1 software, with the level of significance at 5% and the study power at 80%. A minimum of 128 samples (64 infants with CL/CP/CL&CP and 64 healthy controls of the same age and sex; assuming a 1:1 ratio) was required for the current study.

Procedure

After obtaining ethical permission, 66 children with CL/CP who were admitted to the hospital for primary surgery and met the inclusion criteria were included in this study. The study subjects were divided into three groups as presented in (Table/Fig 1).

Study Groups 2A, 2B, and 2C consisted of the same children from Study Groups 1A, 1B, and 1C after six months of their primary surgery. Corresponding age and sex-matched children were selected as controls and divided into three groups (Control Groups 1A, 1B, 1C and Control Groups 2A, 2B, 2C) as shown in (Table/Fig 2).

Growth parameters {weight, height, and Head Circumference (HC)} of all children were measured before primary surgery and six months after their primary surgery using a crown analogue weight machine, infantometer, and HC measuring tape, respectively. Children in the control group who matched the age and sex criteria of the WHO Child Growth Standards (2006) were included, and their growth parameters were evaluated. Study Group-3 comprised the parents of Study Groups 1A, 1B, and 1C, while Study Group-4 included the parents of Study Groups 2A, 2B, and 2C. They were asked to complete a questionnaire before and after their children’s primary surgery. For Control Groups 3 and 4, parents with children of the same age were requested to fill out the questionnaire.

Questionnaire: The RIOFS, a modified 15-item questionnaire (15), which was originally developed from the ‘Impact on Family Scale’ (IOFS) questionnaire, was used to assess the subjectively perceived QoL in the affected families. The RIOFS measured QoL using a four-point Likert scale (strongly agree-1, agree-2, disagree-3, strongly disagree-4). The overall score ranged from 15 to 60, with higher scores indicating better QoL. This modified version of RIOFS (translated into Bengali from English) was a reliable, valid, self-administered, and simple tool that demonstrated better psychometric properties than the original IOFS. Prior to using the RIOFS scale in this study, the reliability and validity of the scale for the study population were assessed. The conversion rate ranged from 0.8 to 1, which was within the acceptable limit, and the Cronbach’s alpha value was 0.771, indicating good reliability and validity of the scale in the study population (16).

Statistical Analysis

Microsoft Excel was used to tabulate data, generate graphs, tables, etc., while the statistical software IBM SPSS Statistics 23.0 (IBM Corporation, Armonk, NY, USA) was employed for data analysis. The mean difference in growth parameters between the study and control groups both before and after primary surgery was analysed using an unpaired t-test. The level of significance was set at p=0.05, and any value less than or equal to 0.05 was deemed statistically significant. The responses to the RIOFS questionnaire were scored as per the recommended guidelines. Participants who were unable to complete the questionnaire were excluded from the final analysis. The difference in overall scores between the study and control groups was assessed using an independent sample t-test. A p-value of <0.05 was considered statistically significant.
Results
A total of 66 children with CL/CP/CL&CP who met the inclusion criteria were included in the current study. Each child’s parent was approached to participate in the study and complete the questionnaire, but the parents of two infants were unwilling to fill out the questionnaire. Therefore, 64 parents were included in the final analysis.

The difference in the mean age of Study Group-1 (4.42±0.48) and Control Group-1 (4.43±0.48) was not statistically significant (p-value=1.00). The frequency distribution of gender (male and female) was similar in each group as no statistically significant difference was found between the two groups (Table/Fig 3)a. Similarly, the difference in the mean age and gender distribution between Study Group-2 and Control Group-2 was not statistically significant, confirming that the pattern of gender distribution was similar in the study and the corresponding control group (Table/Fig 3)b.

Part-1: Comparison of growth parameters of infants with CL/CP/CL&CP before vs. after primary surgery.

This study found that the mean weight, height, and HC of the control groups before surgery were higher than their corresponding study groups. The difference in mean weight between Study Group-1A and Control Group-1A was statistically significant (p-value=0.001), whereas the differences in mean height and HC were not statistically significant (p-value=0.432, 0.160). The differences in mean height and weight between Study Group-1B and Control Group-1B were statistically significant (p-value=0.006, <0.001). However, no statistically significant difference in mean HC was observed between Study Group-1B and Control Group-1B (p-value=0.188). Statistically significant differences in mean height, weight, and HC were observed between Study Group-1C and Control Group-1C (p-value=0.018, 0.002) (Table/Fig 4)a-c.

This study found that the mean weight, height, and HC of the control groups after surgery (Control Group-2A, 2B, 2C) were higher than their corresponding study groups. The differences in mean weight and HC between Study Group-2A and Control Group-2A were statistically significant (p-value <0.001, 0.034). The differences in mean weight and HC between Study Group-2B and Control Group-2B were statistically significant (p-value <0.001, 0.022), whereas no statistically significant difference in mean height was observed between the study and control groups (p-value=0.974). Statistically significant differences in mean height, weight, and HC were observed between Study Group-2C and Control Group-2C (p-value <0.001, <0.001, 0.002) (Table/Fig 5)a-c.

There was a significant improvement in all three growth parameters in the study group before and after surgery (p<0.001) (Table/Fig 6)a-c.

Part-2: Comparison of the RI OFS Score of parents before vs. after primary surgery.

The subjectively perceived QoL was better in parents of healthy children compared to parents of children with CL/CP/CL&CP both before and after surgery. The difference in mean RIOFS score between Study Group-3 and Control Group-3 before primary surgery was statistically significant (p<0.001) (Table/Fig 7). Similarly, the difference in mean RIOFS score between Study Group-4 and Control Group-4 after primary surgery was statistically significant (p<0.001) (Table/Fig 7).

The QoL of parents from the study group improved after surgery. The difference in mean RIOFS score between Study Group-3 and Study Group-4 after primary surgery was statistically significant (p<0.001) (Table/Fig 8).
Discussion
Growth is a key component of nutritional status and an indicator of health and well-being for individuals and populations. Growth in children is typically steady and predictable, with good references available for assessing and comparing growth in children (17). For infants and toddlers under two years of age, anthropometric measurements at each well-visit include weight, length, and HC. For children over two years of age, measurements typically include weight and length (18). The concept of QoL incorporates six broad domains: physical health, psychological state, levels of independence, social relationships, environmental characteristics, and spiritual matters (19). QoL is an important supplementary measure for clinical indicators to assess the family impact of these infants. The presence of orofacial deformities can result in speech difficulties, airway infections, breathing problems, and feeding challenges, leading to nutritional deficiencies and subsequently impaired physical growth (20).

This study measured the key growth parameters of height, weight, and HC in infants with CL/CP/CL&CP both before and after primary surgery, comparing them with their healthy counterparts to determine if a significant difference exists between healthy children and those affected with clefts. Additionally, a comparative evaluation of the QoL of parents of infants with CL/CP/CL&CP and CP was conducted before and after primary surgery to assess the impact of surgical intervention. In the study, for CL defects, only the mean weight differed significantly (p-value=0.001) between infants and the control group, while the height and HC (p-value=0.432 and 0.160) did not show significant differences. The difference in physical growth indices was less significant in infants with CL compared to infants with CP and CL&CP. For isolated CP and CL with CP defects, except for HC in the before-surgery group and height in the after-surgery group, all growth parameters showed significant differences (p-values: weight <0.001, height 0.006, HC 0.188, respectively) between the study and control groups. Cordero E et al., concluded that children with CL&CP receive less breastfeeding and have lower stature-weighted growth than children without CL&CP during the first year of life (21). Weight was found to be the most affected growth parameter in this population.

In this study, for all three parameters-height, weight, and HC, the mean values significantly increased following surgery with a p-value of <0.001. These findings were supported by the concept of ‘catch-up growth’ after the early lag period following surgical intervention, especially in the first two years of the infant’s life. In a similar study, Wu W et al., reported that physical growth issues, i.e., lower weight for age and length for age, were more prevalent in CL/CP infants than in healthy infants due to differences in the food supplied to the patients (6).

In this study, the mean RIOFS Score was higher in the study group constituting the parents of infants with CL and CP of both sexes after primary CL/CP surgery compared to the mean RIOFS Score of the study group consisting of parents of infants with CL and CP of both sexes before primary CL/CP surgery, and the mean difference was statistically significant. This indicates a marked improvement in the QoL of the parents/caregivers of children with CL/CP following surgery. This finding was supported by the study conducted by Emeka CI et al., (3). A cross-sectional research study by Ruiz-Guillén A et al., also demonstrated similar findings, indicating that patients perceived an improvement in their QoL as a result of the treatments received (22). Beluci ML and Genaro KF also reported that the QoL of individuals with CL and CP improved after treatment in the physical, psychological, and environmental domains (23).

Limitation(s)

The present study had several limitations. Firstly, it was a single-centred hospital-based study, which means that generalising the findings to other settings may not be warranted. Additionally, various confounding factors were not considered, such as age, sex, socio-economic background of the participants, educational qualifications of the parents, and dietary habits. Finally, the impacts of each type of cleft on the QoL of the parents or caregivers were not explicitly evaluated. Therefore, it is recommended to conduct a multicentre study with a more diverse study population and a larger sample size for further evaluation.
Conclusion
It can be concluded that the physical growth status of infants with CL/CP/CL&CP defects has shown significant improvement after primary surgery, as evidenced by the findings of the present study. Although the growth was slightly lagging compared to healthy infants of the same age/sex group, all growth parameters-height, weight, and HC-improved considerably, depicting ‘catch-up growth’ after the primary surgery. The QoL was better in parents of healthy children when compared to parents of children with CL/CP/CL&CP. The QoL also significantly improved post-primary surgery. To overcome the limitations of this study, it is necessary to evaluate the growth parameters of infants and the QoL of parents with CL and CP infants before and after primary surgery in multiple centre across the country with a larger population sample.
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DOI and Others
DOI: 10.7860/JCDR/2024/67324.19410

Date of Submission: Sep 08, 2023
Date of Peer Review: Nov 24, 2023
Date of Acceptance: Mar 07, 2024
Date of Publishing: May 01, 2024

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Sep 11, 2023
• Manual Googling: Mar 01, 2024
• iThenticate Software: Mar 04, 2024 (11%)

ETYMOLOGY: Author Origin

EMENDATIONS: 10
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