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

Users Online : 261291

AbstractMaterial and MethodsResultsDiscussionConclusionAcknowledgementReferencesDOI and Others
Article in PDF How to Cite Citation Manager Readers' Comments (0) Audio Visual Article Statistics Link to PUBMED Print this Article Send to a Friend
Advertisers Access Statistics Resources

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 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 : 2023 | Month : February | Volume : 17 | Issue : 2 | Page : FC01 - FC06 Full Version

Prevalence of Adverse Events in Healthcare Professionals Using Personal Protective Equipment to Treat COVID-19: A Web-based Survey


Published: February 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/61461.17501
K Priya Gayathri, R Kavitha Ramasamy, S Ramya, K Punnagai

1. Postgraduate, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India. 2. Professor, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India. 3. Assistant Professor, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India. 4. Head, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.

Correspondence Address :
Dr. K Priya Gayathri,
Postgraduate Student, Department of Pharmacology, Sri Ramachandra Institue of Higher Education and Research, Chennai, Tamil Nadu, India.
E-mail: kpriyagayathri@gmail.com

Abstract

Introduction: Healthcare Professionals (HCPs) involved in managing Coronavirus Disease-2019 (COVID-19) pandemic were instructed to wear Personal Protective Equipment (PPE) to protect themselves from contracting virus. However, PPE use can sometimes lead to adverse events which create greater impact on health status of HCPs. Thus, the prevalence of adverse events and associated risk factors should be estimated for taking necessary preventive measures.

Aim: To evaluate the prevalence of adverse events in HCPs due to PPE use during second wave of COVID-19 in Tamil Nadu, India.

Materials and Methods: A cross-sectional study was conducted in different levels of healthcare centres in Tamil Nadu, India, from April to May 2021. Data were collected using a prevalidated questionnaire from HCPs of any discipline who were directly involved in managing COVID-19 patients. A total of 282 responses were collected through Google forms and proportion of HCPs who experienced adverse events due to PPE and percentage of different adverse events associated with PPE wearing were assessed. Data were analysed using Chi-square test.

Results: Out of 282 respondents of the survey included 224 doctors, 34 nurses and 24 lab technicians with a mean age of 30 years. There were 164 females and 118 males. A total of 177 (62.76%) participants experienced adverse events which included dehydration, thirst and heat, headaches, inability to go to restroom and other urinary/respiratory problems. With respect to duration of exposure to PPE, 163 (57.8%) HCPs had >6 hours/day and 102 (36.2%) had 4-6 hours/day. It was observed that factors such as age, gender, profession, various wards posted for COVID-19 duty and duration of PPE worn daily were significantly associated with adverse events to PPE (p-value <0.05).

Conclusion: The results of the study concluded that higher prevalence of adverse events with PPE was seen among doctors and nurses. Most common encountered adverse events were dehydration, headache and skin problems, which have been associated with prolonged use of PPE.

Keywords

Coronavirus disease-2019, Materiovigilance, Questionnaire, Untoward effects

Coronavirus Disease-2019 (COVID-19), a novel coronavirus disease is a highly infectious acute respiratory disease which has caused a recent major outbreak affecting many countries worldwide (1). It is caused by a pathogen called Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) (2). The pandemic outbreak is initially originated from Wuhan, China in December 2019 and spreads rapidly through transmission from human to human due to close contact with an infected person, with exposure to coughing, sneezing, respiratory droplets or aerosols. The World Health Organisation (WHO) declared that COVID-19 was a “public health emergency of International concern” on 30th January 2020 (3).

Personal Protective Equipment (PPE) complements in control of infection transmission from patients to HCP, other patients and attendants along with other infection control practices. PPE has become pivotal after the emergence of life-threatening infections like severe acute respiratory syndrome, Middle East Respiratory Syndrome (MERS) and COVID-19. There is a substantial need for efficient infection spread control in all healthcare settings (4).

Healthcare Infection Control Practices Advisory Committee (HICPAC), recommends the use of PPE in standard and transmission-based infection control precautions. Standard precautions require the HCPs to anticipate exposures and select appropriate PPEs for use while providing care to patients affected with infectious diseases which are classified as being transmitted through the airborne, contact, or droplet route (5).

The PPE includes disposable N95 masks, goggles, triple layers of medical gloves, a protective face shield, an isolates gown and a medical protective clothing. The use of PPE is associated with high incidence of adverse events such as heat, dehydration, pressure sores, headaches, inability to go to washroom, infections in respiratory tract, urinary tract etc. (6),(7). Most of the adverse events experienced by HCPs while using PPE have not been reported appropriately to concerned personnel who is handling Pharmacovigilance and Materiovigilance Departments due to lack of awareness, time constraint and motivation (8).

Materiovigilance Programme of India (MvPI) was launched in 2015 with an objective to identify and collect the adverse events associated with the use of medical devices and to eliminate the device-related risks through a systematic reporting system (9). In India, the Medical Devices Rules (MDR) became effective from 1st January 2018. The MDR has significantly influenced the postmarketing surveillance of medical devices, by ensuring their quality and user safety (10).

There are many studies conducted on reporting of adverse events due to medical devices like ventilators, vital signs monitor, incubators, infusion pumps, cardiac implants across various countries. But very few studies have been done on evaluating the adverse events due to PPE which mainly focuses particular symptoms like skin reactions, headache and so on (11),(12),(13). This study primarily focuses on overall rate of adverse events caused by PPE to HCPs in various healthcare centres in Tamil Nadu, India, during this pandemic situation and also aimed to evaluate the proportion of various adverse events in association with the various cadre of health professionals, duration of shifts and comfortability.

Material and Methods

A cross-sectional study was conducted in different levels of healthcare centres in Tamil Nadu, India, from April to May 2021. Participation was voluntary and anonymous. The study was conducted after the approval from Institutional Human Ethics Committee (Ref: CSP-MED/21/FEB/66/27). Informed consent was obtained from all the study participants. The study was conducted using a prevalidated questionnaire.

Inclusion criteria: Doctors and nurses who had been directly involved in treating COVID-19 patients in 40 healthcare centres in Tamil Nadu, India, during the study period regardless of speciality and experience were included in the study. Lab personnel involved in blood collection and sample processing for COVID-19 patients were also included in the study.

Exclusion criteria: Participants who were not willing to take part in the survey were excluded from this study.

Sample size calculation: The sample size was determined using Cochran sample size formula for categorical data with a 5% margin of error and a 95% confidence interval level together (level of significance, α=0.05) along with the proportion of Adverse Drug Reactions (ADRs) reported from previous literature (14). Number of participants was derived as 246 respondents, which was the minimum sample size (N) of HCPs required for this study using convenient sampling technique.

N=Z2PQ/d2=(1.96)2*0.80*(0.20)/(0.05)2=246.

Where, Z=95% confidence interval level gives Z value of 1.96
P=Estimated proportion of the population=0.8
Q=1-P
d=desired level of precision (i.e., the margin of error)

Study Procedure

A questionnaire for the survey was drafted based on the previous study by Yu K et al., and modified by the principal investigator of the present study to assess the prevalence of adverse events using PPE among HCPs which consisted of 29 questions with 22 closed ended and seven open ended questions pertaining to the details of basic demographic, training experience, institutional work characteristics, usual practices and availability of PPE, along with perceptions of its adequacy in terms of supply and training in the workplace as well as adverse effects of wearing PPE (15).

Out of 29 questions, 6 (q7, 11, 13, 24, 26, 27) questions were framed regarding knowledge, 3 (q8, 15, 29) regarding attitude and rest were related to practices. The questionnaire was prevalidated for criteria validity, language, understandability, ease of administration and content by faculties of pharmacology (n=4) and experienced physicians from various departments (n=6) in the same institution where the study was conducted excluding principal investigator and co-investigators. Reliability of the questionnaire was measured using Cronbach’s alpha score (0.8).

After validation, survey was prepared in e-Google form in english language and was circulated through e-mails and WhatsApp modes. The participants were briefed about questionnaire filling procedure and requested to do the survey after seeking their informed consent and the responses were collected. Data collected were kept confidential.

Statistical Analysis

Data were entered in Microsoft (MS) excel 2020 and analysed using Statistical Package for Social Sciences (SPSS) software version 20.0. Proportions of adverse events in each group of participants (doctors, nurses and lab technicians) were expressed in percentages. Various associations between HCP’s duration of shift, demographic and occupational related characteristics and more with adverse events were calculated by Chi-square test. Results were considered statistically significant when the p-value was ≤0.05.

Results

In this survey, 282 HCPs participated comprising 224 (79.4%) doctors, 34 (12.1%) nurses and 24 (8.5%) lab technicians from various medical centres in Tamil Nadu, India. Among 282 participants 164 were females and 118 were males with a mean age of 30 years. Majority of HCPs 201 (71.3%) were working from tertiary health institutions followed by primary healthcare 44 (15.6%) and secondary healthcare 37 (13.1%) (Table/Fig 1).

Out of 282 participants, 123 (43.6%) strongly agreed that they were keen to come to work in COVID-19 wards at this pandemic, while 117 (41.5%) participants strongly agreed that they were worried about transmitting disease to their family and 66 (23.4%) strongly agreed that they were worried about contracting COVID-19 inspite of PPE use (Table/Fig 2).

A total of 248 of the 282 participants were posted for COVID-19 duty in four different areas under all levels of healthcare of which a greater number of HCPs were posted in COVID-19 wards. Total 34 were doctors posted in primary health centres from remote areas, where they dealt both COVID-19 and non COVID-19 patients. Totally 190 (67.4%) members had undergone proper training in donning and doffing of PPE in their institutions. Majority of the participants i.e., 74 (26.2%) utilised level 4 PPE, apart from level 4 PPE, 116 participants wore one pair of gloves and 166 wore double gloves. the total ADR’s reported were 177 (62.76%), out of which 21 were treated on Outpatient Department (OPD) basis. A total of 88 (31.2%) participants were affected with COVID-19 and 35 (12.4%) thought it may be due to PPE failure. Among 282 participants, only 134 (47.5%) participants were aware about reporting in materiovigilance program and only 13 (4.6%) had reported the adverse events due to PPE (Table/Fig 3).

There were many adverse events experienced by HCPs among which dehydration, thirst and heat were the most common ADRs encountered followed by inability to go to washroom, extreme exhaustion, headaches skin problems and more, as mentioned in (Table/Fig 4).

With regard to adverse events, it was observed that females experienced a higher number than males and the same was statistically significant (p-value=0.042). Similarly a statistically significant observation was made that doctors were affected most among the HCPs in working place (p-value=0.046), also HCPs who worked in wards and Intensive Care Unit (ICU) were commonly affected followed by those posted in OPD (p-value=0.038). Duty duration of HCPs were significantly associated with prevalence of adverse PPE events in which professionals working for more than six hours in PPE reported a greater number of adverse reaction (p-value=0.033) (Table/Fig 5).

Suggestions from responders, indicated reduction in working hours, improvement in quality of PPE and proper reporting of adverse events to minimise adverse events due to PPE (Table/Fig 6).

Discussion

Even though, treatment protocols have been frequently revised and recommended for management of COVID-19, due to the uncertainty of the infection status of patients, HCPs mandatorily require PPE during their whole duty hours to break the transmission chain (17). The present study estimated the prevalence of ADRs with PPE use among HCPs while treating COVID-19 patients with an objective of gaining knowledge about the commonly encountered untoward events associated with PPE use.

From this study, the overall adverse event rate for healthcare personnel was found to be 62.76%. About 71.87% doctors have reported greater number of adverse events compared to nurses (58.3%) and lab professional (52.94%) (p-value=0.046). Considering workplace, individuals from secondary care institutions suffered a larger quantum of adverse events due to PPE accounting to 83.8% than tertiary (59.7%) and primary institutions (16.1%). Similar findings were noted in previous studies (18),(19).

The present study has shown, 88.7% participants had adequate knowledge about transmission of COVID-19 which correlates with a study conducted by Zhang M et al., in China which showed about 89% of HCPs had sufficient knowledge of COVID-19 (20). The present study also assessed the attitude of participants towards contracting COVID-19 inspite PPE use has shown that 23.4% had a negative attitude and 41.5% worried about transmitting disease to their family. These findings have not been reported earlier. Also, 67.4% participants from the current study had undergone proper training in donning and doffing of PPE. These results nearly match with a study conducted by Pandey S et al., in which 75.6% respondents achieved adequate training (21).

The present study revealed more number of ADRs (42.55%) reported by HCPs who worked more than six hours/day and about 27.61% by HCPs who worked for 4-6 hours/day. The results of the current study coincides with Desai SR et al., who had shown decreased number of adverse events with reduction in the duration of duty to four hours for nurses (22). Participants who wore two layers of gloves had higher proportion of adverse events with 68.7% followed by one layer of gloves use with 61.3% (p-value <0.05).

Considering comfortability with PPE, 149 (52.8%) HCPs have reported that wearing PPE was manageable and 110 (39%) reported it as uncomfortable which were in line with the study conducted by Yildiz CC et al., who observed that 23.15% HCPs reported that wearing aprons, masks, goggles and gloves were uncomfortable (23).

In present study, most common problems encountered with PPE use were found to be dehydration (59.9%), thirst (52.5%), heat (51.4%), inability to go to washroom (41.8%), skin reactions (31.6%), headache (21.6%) and pressure areas (13.1%) due to PPE use. An 83.7% reported excessive sweating after activity with PPE in this study which was identical with a study conducted in Spain which accounted about 70% participants experienced excessive sweating after duty hours (23). Results from similar studies have been summarised and compared with present study in (Table/Fig 7) (18),(19),(24),(25),(26),(27),(28),(29).

In addition to the periodical training about proper usage of PPE among frontline healthcare workers, enhancing the quality of PPE and reducing the working hours with PPE can prevent the potential risks due to PPE use. Awareness about common ADRs with PPE use and importance of reporting untoward events to the concerned authority should be educated among HCPs.

To emphasise the importance of reporting adverse events associated with medical devices like PPE, ventilators etc., the Government of India initiated MvPI in 2015 to ensure safety of medical devices which is currently being coordinated by National Co-ordinating Centre, Indian Pharmacopoeia Commission (IPC) at Ghaziabad with a collaborating centre at Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram. IPC has rolled out PPE adverse event reporting form as part of the MvPI for promoting patient and health worker safety (30).

Limitation(s)

This study may have response and recall bias as the adverse events reported by respondents could not be validated by clinicians. Possible associated risk factors in their daily life outside working place were not included. Quality of PPE and working environment of different participants which were not ascertained in the study design may have influence on the outcome of the study.

Conclusion

The present study has concluded that the prevalence of adverse events with PPE use were more among HCPs especially doctors and nurses who worked more than six hours/day with PPE and the most common encountered adverse events were dehydration, inability to go to washroom, headache and skin problems. Thus, the study emphasise the need in reduction of working hours and providing a safe and secure working condition for the HCPs. This can be further supported by creating awareness among HCPs and prompt adverse event reporting through MvPI which ensures adequate protection and mitigates the harmful effects to the extent possible.

Acknowledgement

The authors thank all the healthcare professionals who gave their valuable time and effort in participating in this study.

Authors contribution: KPG: Principal investigator, prepared the study design, designed the questionnaire, collected, tabulated and analysed the data and prepared the manuscript. RK: Instrumented the preparation of questionnaire, reviewed the study plan, data analysis and carefully reviewed and edited the manuscript. SR: Analysed the results, prepared, reviewed and edited the manuscript. KP: Reviewed and edited the manuscript.

References

1.
Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus–infected pneumonia. New Engl J Med. 2020;382(13):1199-207. [crossref] [PubMed]
2.
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. New Engl J Med. 2020;382(8):727-33. [crossref] [PubMed]
3.
30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations (2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) [Internet]. Available from: https://www.who.int/news/item/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov).
4.
Ong SW, Tan YK, Chia PY, Lee TH, Ng OT, Wong MS, et al. Air, surface environmental, and personal protective equipment contamination by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) from a symptomatic patient. JAMA. 2020;323(16):1610. [crossref] [PubMed]
5.
Phan LT, Maita D, Mortiz DC, Weber R, Fritzen-Pedicini C, Bleasdale SC, et al. Personal protective equipment doffing practices of healthcare workers. J Occup Environ Hyg. 2019;16(8):575-81. [crossref] [PubMed]
6.
Aswad Y, Loleh S. Effect of personal protective equipment (PPE) on oxygen saturation and dehydration status in COVID-19 nurses in Gorontalo province. IOP Conference Series: Earth Env Sci T R So. 2021;819(1):012086. [crossref]
7.
Jose S, Cyriac MC, Dhandapani M. Health problems and skin damages caused by personal protective equipment: Experience of frontline nurses caring for critical COVID-19 patients in Intensive Care Units. Indian J Crit Care Med. 2021;25(2):134-39. [crossref] [PubMed]
8.
Meher BR, Padhy BM, Srinivasan A, Mohanty RR. Awareness, attitude, and practice of materiovigilance among medical professionals at a Tertiary Care Institute of National Importance: A cross-sectional study. Perspect Clin Res. 2022;13(2):94. [crossref] [PubMed]
9.
Dhamini M, Jawahar N, Vignesh M. Materiovigilance programme of India-an overview. Research J Pharm and Tech. 2021;14(2):1137-41. [crossref]
10.
Medical device rules 2017 [Internet]. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadGazette_NotificationsFiles/MedicalDeviceRulegsr78E.
11.
Alsohime F, Temsah MH, Hasan G, Al-Eyadhy A, Gulman S, Issa H, et al. Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital. PLOS ONE. 2019;14(10):e0224233. [crossref] [PubMed]
12.
Kumar A, Kumar A, Goel PK. Cardiac device related infection: A study from a tertiary care hospital in India. Ann Int Med Den Res. 2017;3(4):ME04-ME08. [crossref]
13.
Jose S, Cyriac MC, Dhandapani M. Health problems and skin damages caused by personal protective equipment: Experience of frontline nurses caring for critical COVID-19 patients in Intensive Care Units. Indian J Crit Care Med. 2021;25(2):134-39. [crossref] [PubMed]
14.
Battista RA, Ferraro M, Piccioni LO, Malzanni GE, Bussi M. Personal Protective Equipment (PPE) in COVID-19 pandemic. J Occup Environ Hyg. 2020;63(2):e80-e85. [crossref] [PubMed]
15.
Yu K, Micco AG, Ference E, Levy JM, Smith SS. A survey of personal protective equipment use among us otolaryngologists during the COVID-19 pandemic. Am J Otolaryngol. 2020;41(6):102735. [crossref] [PubMed]
16.
Department of Labor Logo United States department of Labor [Internet]. - General Description and Discussion of the Levels of Protection and Protective Gear | Occupational Safety and Health Administration. Available from: https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.120AppB.
17.
Tirupathi R, Bharathidasan K, Palabindala V, Salim SA, Al-Tawfiq JA. Comprehensive review of mask utility and challenges during the COVID-19 pandemic. Infez Med. 2020;28(suppl 1):57-63. PMID: 32532940.
18.
Tabah A, Ramanan M, Laupland K, Buetti N, Cortegiani A, Mellinghoff J, et al. Personal protective equipment and intensive care unit healthcare worker safety in the COVID-19 era (PPE-SAFE): An international survey. J of Crit Care. 2020;59:70-75. [crossref] [PubMed]
19.
Chowdhury S, Roy S, Iktidar MA, Rahman S, Liza MM, Islam AM, et al. Prevalence of dermatological, oral and neurological problems due to face mask use during COVID-19 and its associated factors among the health care workers of Bangladesh. Plos One. 2022;17(4):e0266790. [crossref] [PubMed]
20.
Zhang M, Zhou M, Tang F, Wang Y, Nie H, Zhang L, et al. Knowledge, attitude, and practice regarding COVID-19 among healthcare workers in Henan, China. J of Hosp Infec. 2020;105(2):183-87. [crossref] [PubMed]
21.
Pandey S, Poudel S, Gaire A, Poudel R, Subedi P, Gurung J, et al. Knowledge, attitude and reported practice regarding donning and doffing of personal protective equipment among frontline healthcare workers against COVID-19 in Nepal: A cross-sectional study. PLOS Global Public Health. 2021;1(11):e0000066. [crossref] [PubMed]
22.
Desai SR, Kovarik C, Brod B, James W, Fitzgerald ME, Preston A, et al. COVID-19 and personal protective equipment: Treatment and prevention of skin conditions related to the occupational use of personal protective equipment. J Am Acad Dermatol. 2020;83(2):675-77. Doi: 10.1016/j.jaad.2020.05.032. Epub 2020 May 15. PMID: 32416206; PMCID: PMC7228687. [crossref] [PubMed]
23.
Yildiz CC, Kaban HU, Tanriverdi FS¸ . COVID-19 pandemic and personal protective equipment: Evaluation of equipment comfort and user attitude. Arch Environ Occup Health. 2022;77(1):01-08. [crossref] [PubMed]
24.
Ozkok Akbulut T, Atci T, Caf N, Süslü H. Increased adverse skin reactions among healthcare workers during COVID-19 outbreak. J Turkish Acad of Dermatol. 2021;15(3):60-64. [crossref]
25.
Jiang Q, Song S, Zhou J, Liu Y, Chen A, Bai Y, et al. The prevalence, characteristics, and prevention status of skin injury caused by personal protective equipment among medical staff in fighting COVID-19: A multicenter, cross-sectional study. Adv in Wound Care. 2020;9(7):357-64. [crossref] [PubMed]
26.
Unoki T, Tamoto M, Ouchi A, Sakuramoto H, Nakayama A, Katayama Y, et al. Personal protective equipment use by health-care workers in intensive care units during the COVID-19 pandemic in Japan: Comparative analysis with the PPE-SAFE survey. Acu Med & Surg. 2020;7(1):e584. [crossref] [PubMed]
27.
Agarwal A, Agarwal S, Motiani P. Difficulties encountered while using ppe kits and how to overcome them: An Indian perspective. Cureus. 2020;12(11):e11652. Doi: 10.7759/cureus.11652. [crossref]
28.
Lim E, Ong B, Seet R. Headaches and the N95 face-mask amongst healthcare providers. Acta Neuro Scand. 2007;116(1):73-73.[crossref]
29.
Ong JJ, Bharatendu C, Goh Y, Tang J, Sooi K, Tan Y, et al. Headaches associated with personal protective equipment– a cross-sectional study among frontline healthcare workers during COVID-19. Headache: J Head and Face Pain. 2020;60(5):864-77. [crossref] [PubMed]
30.
Ray A, Najmi A, Kaore S, Sadasivam B. Role of materiovigilance in Covid era: An update. J Fam Medi and Prim Care. 2021;10(7):2722.[crossref] [PubMed]

DOI and Others

DOI: 10.7860/JCDR/2023/61461.17501

Date of Submission: Nov 14, 2022
Date of Peer Review: Dec 09, 2022
Date of Acceptance: Jan 13, 2023
Date of Publishing: Feb 01, 2023

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. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Nov 30, 2022
• Manual Googling: Jan 06, 2023
• iThenticate Software: Jan 10, 2023 (5%)

Etymology: Author Origin

JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com