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

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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.
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Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
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
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : June | Volume : 16 | Issue : 6 | Page : TC11 - TC17 Full Version

Association between Chest CT Severity Scores and SARS-CoV-2 Vaccination among COVID-19 patients: A Cross-sectional Study from Pune, India


Published: June 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/53056.16482
Ashish Laxman Atre, Akhil Atre, Suhrud Panchawagh, Rahul Khamkar, Aparna Chandorkar, Sunil Patil

1. Chief Radiologist, Department of Radiology, Star Imaging and Research Centre, Pune, Maharashtra, India. 2. Undergraduate Student, Government Medical College Byramjee Jeejeebhoy and Sassoon General Hospitals, Pune, Maharashtra, India, 3. Undergraduate Student, Smt. Kashibai Navale Medical College and General Hospital, Pune, Maharashtra, India. 4. Undergraduate Student, Government Medical College Byramjee Jeejeebhoy and Sassoon General Hospitals, Pune, Maharashtra, India. 5. Research Associate and Radiologist, Department of Radiology, Star Imaging and Research Centre, Pune, Maharashtra, India. 6. Founder, Star Imaging and Research Centre and Associate Professor (Honorary), Department of Radiology, B.J. Government Medical College, Pune, Maharashtra, India.

Correspondence Address :
Ashish Laxman Atre,
Chief Radiologist, Star Imaging and Research Centre, Deccan-Joshi Hospital Campus, Opposite Kamla Nehru Park, Erandawane, Pune, Maharashtra, India.
E-mail: atreal@gmail.com

Abstract

Introduction: The novel Coronavirus disease-2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is seen to primarily affect the human respiratory system. Chest CT Severity Score (CTSS) provides a semi quantitative assessment of pulmonary involvement in COVID-19 patients. COVID-19 pandemic mitigation measures such as SARS-CoV-2 vaccination are being deployed worldwide. However, with the emerging variants of concern of SARS-CoV-2, a high prevalence of post vaccination breakthrough infections is seen.

Aim: To assess the association of CTSS with the vaccination status in a cohort of COVID-19 patients referred to a tertiary diagnostic centre and to evaluate the association of CTSS with other clinical parameters including co-morbidities in these patients.

Materials and Methods: This cross-sectional observational study was conducted at a tertiary care diagnostic imaging centre in the city of Pune, Maharashtra, India. Data of 1002 symptomatic, adult patients who underwent chest CT and SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)/Rapid Antigen Test (RAT) laboratory test between March 13, 2021 and June 22, 2021, were collected. COVID-19 reporting and Data System (CO-RADS) categories and the corresponding semi quantitative CTSS were calculated for each patient. Based on their vaccination status, patients were categorised into three groups: unvaccinated, partially vaccinated and fully vaccinated. The association of CTSS with various categories of vaccination status, demographics, co-morbidities and stages of the disease of the patients, was evaluated.

Results: Of the 1002 COVID-19 patients, 768 (76.6%) were unvaccinated, 190 (19.0%) were partially vaccinated and 44 (4.4%) were fully vaccinated. Mean CTSS in the fully vaccinated cohort was significantly lower (3.75±4.7) than that in the partially vaccinated (6.05±5.7) and unvaccinated (8.29±4.9) patients (mean 3.75 vs. 6.05 vs. 8.29, respectively; (p< 0.05). Mean CTSS in patients with no co-morbidities was significantly lower than that in patients with hypertension and diabetes (7.12 vs. 8.75 vs. 10.39, respectively; (p< 0.05).

Conclusion: Significant association was noted between the Chest CTSS and the vaccination status, age, gender, co-morbidities and stage of disease in this large cohort of COVID-19 patients. The study reiterates that full vaccination aids in reducing the severity of lung involvement in COVID-19 infection.

Keywords

Computed tomography, Coronavirus, Diagnostic imaging, Immunisation, Respiratory tract infections

High Resolution Computed Tomography (HRCT) of the chest plays a pivotal role in assessing the severity of lung involvement in novel Coronavirus disease-2019 (COVID-19) infection (1),(2),(3). The COVID-19 Reporting and Data System (CO-RADS) and the corresponding CT Severity Score (CTSS) introduced by Radiological Society of the Netherlands provide a semi quantitative assessment of virus induced pulmonary involvement (4),(5).

Mass vaccination is considered to be an important tool for COVID-19 disease prevention. India’s COVID-19 vaccination program was expanded to include all citizens ≥18 years of age, even as the country witnessed a massive surge in infections during the 2nd wave of the pandemic (6). The ChAdOx1n CoV-19/Covishield and BBV152/Covaxin are the two vaccines approved for emergency use in India (7). However, vaccines do not confer complete immunity against the viral disease and vaccine breakthrough infections are being reported (8),(9).

Studies have reported that chest CTSS correlates with the extent of lung damage in COVID-19 patients and therefore, may be used as a novel indirect indicator of vaccine effectiveness in the real world settings (2),(3),(10). Studies comparing the chest CTSS and vaccination status among Indian patients with COVID-19 infection are scarce (one of these studies was a preprint at the time of writing this paper) (11),(12),(13).

On this background, the present study aimed to assess the association between chest CTSS and vaccination status in a cohort of Indian patients with COVID-19 infection. The secondary objective of this study was to assess the correlation between CTSS and the clinical parameters including co-morbidities in these patients.

Material and Methods

This cross-sectional, observational study was conducted at the imaging clinics of a tertiary diagnostic centre, in Pune, Maharashtra, India, between March 13, 2021 and June 22, 2021. This tertiary care diagnostic imaging centre receives referrals from various parts of Pune district. The study was approved by Institutional Ethics Committee (ECR/311/INST/MH/2013/RR-19) and informed consent was obtained from all the patients.

Sample size calculation: Optimum sample size for the study was estimated using the formula: N=(1.96)2 PQ/L2. Where, N=Sample size, 1.96= Standard normal deviate set corresponding to 95% confidence interval (CI), P=Percentage of vaccinated population in Pune district till June 2021, Q=100-P and L=Permissible error in estimation i.e., 10% of P.

Percentage of vaccinated population in Pune district till June 2021 (P), was calculated using the formula: P=total number of SARS-CoV-2 vaccinations done in Pune district till June 2021 i.e., 32, 17, 978 persons×100/total population of Pune district i.e.,1, 00, 89, 916 persons, estimated in accordance with the Aadhaar uidai.gov.in December 2020 data (14),(15),(16). Thus, the sample size calculated for this study was 820 patients (Table/Fig 1). Taking into consideration the possible loss to follow-up of 20 % in an urban setting, the estimated optimum sample size for this study was further increased to 984 patients (Table/Fig 1). The present study therefore included 1002 patients with COVID-19 infection.

Inclusion criteria:

• Age ≥18 years;
• Patients suspected to have symptoms of COVID-19 infection;
• Patients who were referred for HRCT chest between March 2021 and June 2021;
• Patients with a positive SARS-CoV-2 Reverse Transcription Polymerase Chain Reaction (RT-PCR)/Rapid Antigen Test (RAT).

Exclusion criteria: Pregnant women, patients <18 years of age and patients with a negative RT-PCR/RAT test.

Study Procedure

Data collection: Clinical data, laboratory data (SARS-CoV-2 RT-PCR/RAT tests) and vaccination data of the study patients were collected from electronic medical records, patient’s clinical history sheets, and from telephonic interviews. Clinical information collected from all study patients included: age, gender, co-morbidities and stage of illness based on the time interval between onset of symptoms and acquisition of chest HRCT scan.

Chest HRCT evaluation: As a standard of practice, non contrast chest HRCT scans of the COVID-19 patients were performed on a multidetector CT scanner (Philips Ingenuity 128 Slice CT; Philips Healthcare, Amsterdam, Netherlands and GE 32 Slice; GE Healthcare, Waukesha, USA) with the patient in supine position, during end inspiration. Scanning parameters were in line with the manufacturer’s standard recommendations for a routine thorax scan. All CT images were reconstructed to thin slices using the Multiplanar Reformatting (MPR) technique. Appropriate infection prevention and control measures were arranged for the CT technologists and the patients.

HRCT images of the COVID-19 patients were independently examined on standardised workstations, by two radiologists with 15 years’ experience in reporting chest CT images. These radiologists were blinded to the vaccination as well as co-morbidity status of the study patients. Chest CT scores for the first 30 study patients were recorded by the two radiologists independently. Intra Class Correlation (ICC), which is a useful statistic for estimating Inter-Rater Reliability (IRR), was calculated for these reads. The ICC for the initial 30 chest HRCT reads were found to be 0.997 with average measures (p-value=0.0001) and the estimated IRR was 99.7% (Table/Fig 2). Hence, the chest HRCT scans of the remaining study patients, were randomly assigned to the two experienced radiologists for independent interpretation and scoring of the HRCT images.

Chest CT images of these patients were evaluated using the standard, international nomenclature based on COVID-19 Reporting and Data System (CO-RADS) (Table/Fig 3)a (4). Further, in patients with characteristic findings of COVID-19 lung involvement, a semi quantitative CT severity scoring was performed; using the scoring system which depends on the visual assessment of the extent of anatomic involvement (on a scale from 0-5) of each of the 5 lobes of the lungs (Table/Fig 3)b (17). The total CTSS is the sum of the individual lobar scores and it ranges from 0=no involvement to 25 maximum involvement (17). Based on the total CTSS, the severity of lung involvement in the patients was further graded into mild (CTSS of 0-8), moderate (CTSS of 9-15) and severe (CTSS of 16-25) categories.Thereafter, CT scans were further categorised into five stages based on the duration of time interval between initial symptoms’ onset and performance of chest HRCT (Table/Fig 3)c (18).

Vaccination status: The study patients were categorised into the following three groups, based upon their vaccination status at the time of a positive laboratory confirmation of COVID-19 infection.

1) Unvaccinated (never received a COVID-19 vaccine dose);
2) Partially vaccinated (received one dose of a two dose vaccine series, or <14 days elapsed after the 2nd dose);
3) Fully vaccinated (received two doses of a two dose vaccine series and ≥14 days elapsed since the second dose).

Statistical Analysis

Statistical analysis of the data was perfomed using Epi info software. Descriptive statistics of patient’s demographics and clinical results were reported as numbers (n) and percentages (%). Quantitative continuous variables were presented as mean±standard deviation. Analysis of Variance (ANOVA) test was applied to assess the significance of association between mean CTSS and various categories of vaccination status and clinical parameters of the study participants. Kruskal-Wallis test was used for confirmation of results of multiple comparisons. The differences in grades of chest CTSS between the various categories of patients based on their demographic, comorbidity and vaccination status and stage of disease; were examined using Chi-square (χ2) test. Multivariate linear regression analysis was used to determine the association of CTSS with the vaccination status (unvaccinated or vaccinated), comorbidity status (presence or absence of comorbidity) and stages of disease on CT. For all the statistical tests; p-value < 0.05 was considered statistically significant.

Results

Mean age of the 1002 patients enrolled for the study was 49.0 years±15.6 years and men constituted 64.4% of the study population. Study patients were classified into three age group categories based on the prioritisation of vaccination among the Indian population as per the directives of National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) (6).

Co-morbidity data was available in 949/1002 patients. Amongst these, 249 (26.2%) patients had some co-morbidities: either hypertension or Diabetes Mellitus (DM), or a combination of both DM and hypertension, which depicts the baseline demographic and clinical characteristics of the patients (Table/Fig 4).

Out of the 1002 patients, 768 (76.6%) were unvaccinated. Details of the categorisation of the study cohort depending on their CTSS, stage of lung involvement on CT and vaccination status are presented in (Table/Fig 5). Various grades of severity of lung involvement seen on the chest HRCT images of the study patients with COVID-19 infection are illustrated in (Table/Fig 6). Breakthrough infections (defined as SARS-CoV-2 infections occurring ≥14 days after completing the second dose of a two dose COVID-19 vaccination series); occurred in 44 (4.4%) patients.

Association of CTSS with age groups and gender: The study results showed significant difference in the mean CTSS when all the age group categories in the study population were compared together (p< 0.01). Mean CTSS of the persons ≥60 years of age was higher than that of persons in the 45-59 years age group and 18-44 years age group (Mean CTSS 9.34 vs. 8.35 vs. 6.00, respectively) (Table/Fig 7)a. Similarly, significant difference was observed in the grades of chest CTSS of patients depending upon their age group categories. As depicted in (Table/Fig 7)b, moderate as well as severe grades of CTSS were increasingly seen in the 45-59 years and ≥60 years age group categories.

The mean CTSS in male patients was significantly higher than that in the female patients (Mean CTSS 8.0 vs. 7.05 respectively) (p=0.01, p< 0.05). Mild grade of CTSS was seen in greater percentage of female patients (64.1%); as compared to male patients (56%). Significant difference was detected in the grades of CTSS when compared together, based on the gender of study participants (p=0.027, p< 0.05).

Association of CTSS with co-morbidities: Mean CTSS in patients with no co-morbidity was significantly lower than that in patients with comorbidities such as hypertension alone, hypertension with diabetes mellitus and diabetes alone (7.12 vs. 8.75 vs. 9.46. vs. 10.39, respectively (p< 0.05) (Table/Fig 8). Mild CTSS was seen in majority of the patients (64.3%) with no co-morbidities; whereas, highest percentage of cases (20%) with severe CTSS were seen in patients with diabetes mellitus (Table/Fig 9). Significant difference was seen in the mean CTSS as well as in the grades of CTSS, when all groups were compared together, based on their co-morbidity status (p< 0.01).

Association of CTSS with vaccination status: Majority of the vaccinated persons in the study cohort belonged to >60 years and 45-59 years age group. Breakthrough infections were identified in 44 (4.4%) of the vaccinated cohort. When multiple comparisons were made, mean CTSS was significantly higher in the unvaccinated cohort (mean±SD:8.29±4.9) versus the partially vaccinated patients (mean±SD:6.05±5.7) versus the fully vaccinated patients (mean±SD:3.75±4.7) (p< 0.01) (Table/Fig 10). The difference in mean CTSS between the partially vaccinated and fully vaccinated groups was also found to be significant (p=0.035, p< 0.05).

The percentage distribution of mild, moderate and severe grades of CTSS amongst the unvaccinated, partially vaccinated and fully vaccinated groups of patients is illustrated in (Table/Fig 11). Majority of the fully vaccinated patients (86.4%) demonstrated mild CTSS; whereas highest percentage of severe CTSS (11.5%) was reported in the unvaccinated patient group. This difference in the grades of CTSS observed in the different patient categories depending on their vaccination status, was statistically significant (p< 0.01).

Association of CTSS with the two types of COVID-19 vaccines: Amongst the vaccinated cohort, 207 (88.5%) patients had received Covishield and 27 (11.5%) persons had received Covaxin. The difference between mean CTSS of patients who had received Covishield (Mean±SD:5.61±4.9) and that of patients who had received Covaxin (Mean±SD: 5.67±4.6); was statistically insignificant (p=0.954, p>0.05).

Association of CTSS with stage of lung involvement on CT: Statistically significant difference was noted in the mean CTSS among the five stages of lung involvement on CT based on the period between onset of symptoms and acquisition of CT scan (p< 0.01), (Table/Fig 12).

Further, occurrence of mild grade of CTSS in majority (89.3%) of the patients belonging to the fully vaccinated cohort with no co-morbidity, was demonstrated in the two-way cross tables. None (0%) of these patients recorded severe CTSS. On the contrary, a large percentage of unvaccinated patients with co-morbidity; demonstrated either moderate or severe CTSS (Table/Fig 13).

Taking into account, the confounding effect of all the included independent variables, multivariate linear regression analysis showed that presence of co-morbidity and higher stage of disease were associated with higher CTSS; whereas partially/fully vaccinated patients recorded lower CTSS when compared with unvaccinated patients (adjusted R2 is 0.230) (Table/Fig 14).

Discussion

In the course of evolution of the COVID-19 global pandemic, several studies have shown that various patient related factors such as age, gender, duration of symptoms, along with the number and type of co-morbidities; influence the clinical severity and outcomes of patients with COVID-19 infections (3),(17),(18),(19),(20),(21),(22). Scientific literature till date has demonstrated the correlation between the clinical severity of COVID-19 disease and chest CTSS in COVID-19 patients (1),(2),(3),(23),(24),(25).

Further, National SARS CoV-2 vaccination drive is underway in India as part of the global efforts to abate the onslaught of the pandemic (6). Even so, post vaccination breakthrough infections, mainly attributable to the emergence of new variants of SARS-CoV-2 virus; are being reported all over the world, as well as in India (8),(9),(26),(27).

In these settings, the present study assessed the association between CTSS and vaccination status in RT-PCR/RAT confirmed, symptomatic COVID-19 patients, during the second wave of the pandemic in India. The association between CTSS and clinical parameters of these patients were also investigated. Results of this study demonstrated that patients with partial and full vaccination record significantly lower mean CTSS and also report lower percentage of patients with severe grade of CTSS; when compared with the unvaccinated patient population (Table/Fig 10), (Table/Fig 11). These results corroborated with those of previously conducted, similar Indian studies comparing chest CTSS amongst the unvaccinated and vaccinated COVID-19 patients (one of these studies was a preprint at the time of writing this paper) (11),(12),(13). In comparison with these studies, the present study included a larger cohort of patients.

In the present study, majority (86.4%) of the fully vaccinated patients with breakthrough infections, demonstrated mild CTSS and only 1 patient (2.3%) recorded severe CTSS. In line with previous literature reports, this data also illustrated that majority of the patients with post vaccination breakthrough infections suffer from mild disease (11),(12),(13),(26),(27). All of the above mentioned results in the present study can be ascribed to the effectiveness of vaccines in preventing severe COVID-19 disease.

Patients of different age groups in the Indian population are receiving vaccines in a phased manner, as prioritisation of vaccination to the elderly population at an increased risk for developing severe COVID-19 infection; is crucial (6). Therefore, the younger age group (18-44 years) made a sizeable contribution to the unvaccinated category (91.1%) in the current study cohort. Similar to the observations reported by previous studies, this study recorded a higher mean CTSS along with a greater percentage of patients with severe CTSS, in the middle aged (45-59 years) and elderly ( >60 years) population (3),(19). One reason for this observation could be the stage of the pandemic when this study was conducted and another possible reason may be that COVID-19 infection elicits a stronger inflammatory response in the elderly population since they are more likely to have concomitant co-morbidities (19).

Higher mean CTSS and greater percentage of cases with moderate and severe grades of CTSS were seen in the male population in this study. Saeed GA et al., and Jin J-M et al., have reported in their respective studies that, men are at a higher risk of severe COVID-19 disease as compared to women and our results support their observation (3),(20).

As expected, the authors of the present study found a significantly higher mean CTSS in patients with one or more co-morbidities, when compared with patients with no co-morbidities (Table/Fig 8) (21). Also, severe CTSS was more commonly recorded in the patients with diabetes mellitus alone followed by patients with both DM and hypertension; further followed by those with hypertension alone (Table/Fig 9) (22). Overall, these findings are in agreement with the existing literature reports that have documented the impact of co-morbidities on clinical outcomes of patients with COVID-19 (21),(22). In the current study cohort of breakthrough infections, the fully vaccinated patient with severe CTSS was 75 years of age and had co-morbidities such as diabetes and hypertension.

Pan F et al and Ding X et al in their respective studies found that the chest CT features and CT scores of patients with COVID-19, changed with duration of symptoms (17),(18). Consistent with these studies, the present study reported significantly lower mean CTSS and milder grades of CT scores in patients in the early stages of the disease. The mean CT scores were seen to progressively increase from stage 1 to stage 5.

Limitation(s)

The study cohort did not include asymptomatic and RT-PCR false negative persons; who are likely to promote spread of COVID-19 infection. Another limitation was self reporting and under reporting of co-morbidities in some of the enrolled patients. Data on obesity, ischemic heart disease, chronic renal disease and prior lung disease was not available. Details about the clinical categorisation and treatment received by the study patients were also not available. Follow-up chest CT scans were performed in some patients on the basis of clinical indication. However, such serial chest CT scans were not included in the study analysis. Further multicentric studies involving larger groups of COVID-19 patients are recommended to validate the results of this study and to evaluate the impact of SARS-CoV-2 vaccination on the overall patient outcomes.

Conclusion

Significant association between the chest CTSS and the vaccination status, age, gender, co-morbidities and stage of disease was seen, in this large cohort of COVID-19 patients from a tertiary care diagnostic centre in Pune, Maharashtra, India. This study conducted in real world settings, reiterates that full vaccination aids in reducing the severity of lung damage in COVID-19 infections. It therefore, underscores the role played by vaccines in curbing the current COVID-19 pandemic.

Acknowledgement

The authors would like to thank Mrs. Aruna Deshpande MSc.(Statistics), for her help in statistical analysis.

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DOI and Others

DOI: 10.7860/JCDR/2022/53056.16482

Date of Submission: Oct 31, 2021
Date of Peer Review: Jan 07, 2022
Date of Acceptance: Mar 06, 2022
Date of Publishing: Jun 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: Funded by Maharashtra Medical Research Society, Joshi
Hospital, Pune, Maharashtra, India.
• 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

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