key: cord-0800566-n2jkp5r7 authors: Maheshwari, Ashish; Varshney, Mohit; Gupta, Kamini; Bajpai, Meenu title: Psychological assessment and lived experiences of recovered COVID-19 patients who presented for convalescent plasma donation date: 2021-04-22 journal: Transfus Clin Biol DOI: 10.1016/j.tracli.2021.04.008 sha: f29e83264dd2bbd8e318754bdd4c88ed8d203826 doc_id: 800566 cord_uid: n2jkp5r7 Background Increasingly, it has been seen that patients recovering from COVID-19 may face a second battle of coping with its mental health ramifications. These psychological issues can even be experienced by patients who were asymptomatic or had mild to moderate symptoms, potentially impacting their quality of life. Methodology This was a prospective observational study to analyse the psychological impact of COVID-19 in recovered patients who presented as prospective convalescent plasma (CP) donors. An interview for the psychological assessment of the prospective donors was carried out. Depression and anxiety in the participants were assessed by HAM-A, and HAM-D scores and Quality of Life were assessed using the WHOQOL-BREF scale. Results A total of 51 prospective donors were assessed, with a mean age of 34.37 (±9.08) years, with the majority being males (46). No clinically significant depression and anxiety were found on the basis of HAM-D and HAM-A scores. The worst affected quality of life parameter, based on the WHOQOL-BREF scale, was physical quality of life followed by environmental, psychological, and social relationships. Moreover, due to infection, social stigma was experienced by 49.02% of the donors, while 21.97% had anxiety related to convalescent plasma donation as a common livid experience. Conclusion Poor quality of life and social stigma during the recovery phase is prevalent in COVID-19 recovered patients, for which formulation of holistic support strategies are the need of the hour. Comment 2: Even though it was a prospective observational study, a hypothesis regarding the results should be made. Response: We have corrected and added this in the manuscript in the introduction section as highlighted changes. Comment 3: Authors should end the introduction section with the results that were expected from participants and that motivated this study. We have corrected and added this in the manuscript in the introduction section as highlighted changes. Page 5 of 24 J o u r n a l P r e -p r o o f Methodology Section: Comment 4: "Informed consent for convalescent plasma donation" is mentioned, does it mean that donors also consented for the study protocol? If so, this information should be written more explicitly. Response: Yes, we have taken additional consent from Convalescent plasma donors for participating in the study which was absolutely voluntary beyond their Convalescent plasma donation process. Further donors were informed that participating or not participating in the study will not affect their donation process. Information in the methodology section has been written in more explicit way as per reviewer's suggestion. Comment 5: The "WHOQOL" section lacks references and the interpretation of the results should be detailed as for the HDRS. Response: As suggested, appropriate reference for WHOQOL-BREF has been added in the revised manuscript. Comment 6: How is constructed the WHOQOL-BREF? How should the results be interpreted? Response: WHOQOL-BREF has been constructed from WHO Quality of Life scale -100 and validated for use both in India and globally. This is essentially a brief version and results are interpreted in four domains of quality of life, namely: Physical, psychological, environmental and social. This is not a author constructed instrument and a confusing line has been removed from the Page 6 of 24 J o u r n a l P r e -p r o o f methodology section in revised manuscript. The interpretation of results is out of a score of 100 with higher scores denoting higher quality of life. The reference for this has also been provided. Comment 7: Since it is a prospective study, I find that the use of a qualitative measure with the interview of donors is a good idea. However, the methodology should be more detailed. Response: As per the best of our understanding, detailed information has been added in the methodology section of revised manuscript. Comment 8: How were the interviews conducted? Response: One-to-one interviews were conducted by a trained physician in a specially designated area for Donor counseling and medical screening to make a donor feel comfortable during their interview. The same information has been added in the methodology section. Comment 9: Were they structured/semi-structured/open interviews? If they were structured or semi-structured, the main questions should be detailed. Response: Donor interviews were conducted in a structured way following a structured set of questions, although interviewing physicians were open to listening and responding to all the queries raised by convalescent plasma donors at any step of the interview. As far as the lived experiences are concerned patients were asked to elaborate on their experiences during the illness and recovery period till the time they wanted to speak or till the time there was no repetition of themes in the interview. Page 7 of 24 J o u r n a l P r e -p r o o f Comment 10: The way it is written in the methodology I understand that only the lived experiences are addressed through those interviews, but when reading the results section, it seems that the interviews also addressed anxiety regarding plasma donation. Response: This critical point is well acknowledged, and the authors have modified the methodology according to the reviewer's suggestions. Comment 11: The way the WHOQOL is detailed in the methodology, I do not know how to read the results of this section. Response: The results of WHOQOL-BREF have been reported according to standard guidelines as listed in the WHO manual. As suggested earlier and in revised manuscript as well, higher scores indicate higher quality of life. Comment 12: In the "LIVED experiences" section, results are reduced to simple frequencies. The use of a qualitative methodology should enable authors to go into more qualitative details (using verbatims) to illustrate the different categories. Response: We acknowledge the critical point raised by the reviewer on this aspect. This point was discussed amongst the investigators as well, before thematic analysis. For the purpose of improved reader understanding, we decided to present the results in the current form. We agree with the reviewer that verbatim could have yielded in depth results. The same line has been added in the limitations section of the paper. J o u r n a l P r e -p r o o f Comment 13: What were the words commonly used by donors that referred to the idea of "Social stimga", "fear of reinfection", "anxiety for plasma donation", etc. ? Response: These were words deducted after thematic analysis and were part of statements given by patients during detailed one to one conversation based on donor's experiences during infection and recovery period. Comment 14: Regarding anxiety for plasma donation I find it even more important that we need to understand if they were anxious about plasma donation in general, or about something specific relevant to "convalescent plasma donation"? Response: Yes, all donors were first-time plasma donors as well, so they were a bit anxious as well as curious about it and once pre-donation counselling was done they were comfortable for convalescent plasma donation. Additionally, the donors were also anxious about hospital exposure due to COVID-19 and quarantine guidelines. Comment 15: Overall, anxiety, and depression have increased in the general population. I believe the discussion should include a section about the reliability of the usual standard measures. If the mean anxiety has increase in the general population, can we continue to evaluate samples of this population without comparing them to a control condition? Response: We agree to the reviewer about the general increase in these psychological issues during the pandemic. However, we evaluated this recovered population who were at a unique place psychologically since they had successfully recovered from COVID-19. Moreover, since we did Page 9 of 24 J o u r n a l P r e -p r o o f not have psychological condition data in recovered individuals during the early phase of pandemic (period when the study was conducted), we did not attempt to compare them while planning the study. We have added this in the limitations section of revised manuscript. Comment 16: Since this study was observational, conducted on 51 participants, the results section states that "one of the participants scored above the mild severity level of anxiety" and "Similarly, for depression, the mean HAM-D score was 8.51, which is just around the cut off level", and regarding the reflexion about reliability of such measures in such a crisis: I believe the conclusion cannot affirm that "people who have recovered from COVID-19 should be screened for depression and anxiety". However, it is clear that further research is needed to replicate those results. Response: Conclusion has been modified as "People who have been recovered from COVID-19 should be screened and counseled accordingly for depression and anxiety related to plasma donation." Comment 17: -Page 9; Line 22 -Authors used "WHOBREF-QOL scale" while they used "WHOQOL-BREF scale" in the methodology section. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 India has ranked second in the number of COVID-19 affected persons in the world. Currently, more than 100,00,000 have been infected people so far, with 1,00,000 plus deaths (1, 2) . COVID-19 is swiftly affecting the global population, and at present, definitive treatments are still evolving (3, 4) . This virus has a very high infectivity rate, as well as significant morbidity and mortality, which leads to fear and anxiety in the community concerning the risk of infection (5 in the people who were infected and remained in isolation and quarantine during their disease course and recovery phase (12) . Moreover, recovering patients can face a significant degree of social stigma, even after testing negative for the virus (13, 14) . Although numerous newspaper articles have mentioned these patients' lived experiences, there is no systematic study of the same. In the first phase of the COVID-19 pandemic, we need to explore various psychosocial aspects of 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 Page 13 of 24 J o u r n a l P r e -p r o o f (identifier: NCT04346446). Ethical approval was taken before the conduction of this study. All donors who had recovered from COVID-19 and were symptom-free and RT-PCR negative at least 14 days before donation were assessed for their mental health and emotional well-being. All the prospective CP donors were given necessary information regarding tests to be performed before the procedure, donation process, along with pre and post-donation advice by the counselor. For the purpose of this study, a separate informed consent was taken, and donors were informed that non-participation will have no consequences over their donation process. The donors were screened as per the rules laid down by the Drugs and Cosmetics Act and Rules and its further amendments (16) . Donation-related queries were acknowledged and resolved. They were advised to follow the guidelines laid by the government health authorities during the pandemic period. In the study, all donors underwent interviews for the psychological assessment which was conducted before revealing the deferral or acceptance results to the donors, hence eliminating the chances of negative emotions due to deferral. This step was done after obtaining written informed consent for CP donation. Their quality of life and lived experiences were recorded. If donors were deferred due to any medical reason, they were counseled and referred for further management. (18) . Both the scales are freely available and have been previously used in clinical studies (19) (20) (21) . The In the analysis, continuous variables were expressed in the median (range) and mean (SD). The frequency of different scores was analysed through percentages. Statistical analysis was done using SPSS software for windows version 22 (SPSS Inc., Chicago, IL). We assessed a total of 51 prospective donors. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 Page 16 of 24 J o u r n a l P r e -p r o o f phone calls by police and local authorities. Some of the less frequent experiences like "fear of being tracked" by government authorities were reported by three donors (5.88%); feeling "stressed" during the infection period by six donors (11.76%); worry for the family by two donors (3.92%); feeling "guilt" for infecting family members by two donors (3.92%). All the donors were distressed due to witnessing other COVID-19 patients' suffering in the hospitals during their stay. They were keen to help them in order to overcome the difficult situation showing an "empathic altruism." During the study period in India, when the number of cases was rising, the situation was getting worse day by day; both the physical and mental health of COVID-19 patients was affected due to the nature of the disease and associated isolation required in the post-disease phase. The convalescent plasma donors were a unique representation of recovered COVID-19 patients who have fought the disease and recovered. They were suitable individuals for the interview as they felt good and positive while expecting to be socially honored by donating convalescent plasma and helping other COVID-19 patients. Recruitment of convalescent plasma donors was tough and challenging as many were unwilling to come to the hospital setting after a lengthy stay at hospitals for COVID-19. We took steps to ensure a positive donor experience by arranging transportation for donors during the lockdown. We arranged a facility for interviews, counseling, and donation separate from patient areas in the hospital to allay prospective donors' fears. The personal attention was given to each donor for resolving their queries and doubts regarding the disease, its recovery process, and CP donation was done in a congenial environment. In our study, a significant proportion of recovered COVID-19 donors had crossed the screening cut-off of HDRS, but no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 Page 17 of 24 J o u r n a l P r e -p r o o f participant crossed the score for moderate depression. Possibly it could be due to CP donation in our study was voluntary, and hence those with higher levels of depression and anxiety were not likely to come forward for donation indicating the possibility of a sampling bias. The study also indicated impairment in physical and psychological quality of life (based on WHOQOL-BREF) of the participants, which has also been shown in previous studies among COVID -19 affected (24,25) and recovered patients at one month follow up (26) . We analysed the lived experiences during the COVID-19 disease period as well as during the recovery period. Approximately half of the CP donors reported feeling stigmatized during the recovery phase, and the same continued even after complete recovery. This finding was similar to the results from a study on COVID-19 recovered patients and healthcare workers from India and Nepal (13, 27) . Another important aspect was the "fear of reinfection" among the participants. Reinfection is an imperative yet poorly understood phenomenon in this illness, and hence the fear seems justifiable in recovered patients (28, 29) . There have been few isolated case reports about the same globally, and our study indicates that this is an important area where healthcare staff should discuss and allay the fears of the recovered patients. In our study, major lived experiences in plasma donors were social stigma, fear of reinfection, and willingness to help other COVID-19 patients after encouragement by hospital staff and media persons. However, we also found that plasma donors were motivated by "empathy altruism" as a reason for the donation. Ferguson and Lawrence's famous mechanism of altruism (MOA) approach indicates that blood donors are not purely altruists, although they can be motivated by warm-glow and reluctant altruism. Their findings indicated that incentives, either charitable or financial, warm-glow appeals, reciprocal altruism, and empathy altruism could be the blood donation approach (30). 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 this data was captured during the initial part of the pandemic, and considering the disease's evolving socio-economic ramifications, so these findings should be seen in context to its timing when knowledge regarding the disease was scarce. Since we did not have psychological condition data in recovered individuals during the early phase of pandemic (the period when the study was conducted), we did not attempt to compare with the general population. However, this could have added value to the objective findings of this study. Lastly, no systematic instrument was used to measure the lived experiences and qualititative verbatims were converted to themes and their frequencies are presented. Actual verbatim could have givem more indepth understanding of their experiences. Despite the limitations, this was the first systematic attempt to understand the psychological issues in COVID-19 recovered CP donors from India; to the best of our knowledge. Hence, this data can provide the basis of more extensive longitudinal studies to understand and better address the needs of CP donors, and other COVID-19 recovered patients. Future studies should also try to understand the difference in psychosocial issues among voluntary and replacement donors. 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