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A Kidney Transplant Patient with Mild Covid‐19 – Case Report Writing

Guidelines for Publication and the Importance Of Gdpr

Dr. Nancy Agens, Head,

Technical Operations, Pubrica

sales@pubrica.com

In Brief

Case study report writing is an important

component of scientific medical writing.

However, legal obligations for writing a

case report are strict to safeguard

identity, privacy, and interests of the data

subject. GDPR formulated by hey the

European Union Is an important step

towards ensuring the same.

Keywords: Case Report Writing Services,

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a Case Report, how to write a medical

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service.

I. REPORTING A CASE

Case reporting is an integral part of

knowledge dissemination in medical

science. A single case is often reported to

highlight circumstances during

management of not so common diseases.

Writing a case report is a quick way to

report unique cases, sharing information

about the difficulty in diagnosis, unique

approach required for management of the

case and the learning outcome.

II. KIDNEY TRANSPLANT PATIENT

WITH MILD COVID-19

COVID-19 pandemic has been a

challenge in both the developed as well as

developing countries with respect to

prediction of the outcome in different

patients, prognostic factors, and

management protocols. Mortality rate of 1-

6% Has been reported from different parts

of the world. Comorbidities like diabetes,

hypertension, obesity, specially in the

elderly population are known to contribute

to poor prognosis. Like all other viral

diseases, COVID-19 presents in an

atypical manner in immunocompromised

and immunosuppressed patients. Hence,

often diagnosis in such patients is based on

strong clinical suspicion rather than

laboratory investigations.

Aprilia et al have reported clinical

features and treatment approach for a

patient with kidney transplant and

COVID-19. They have recommended that

the screening protocols should be re-

evaluated in patients in patients with solid-

organ transplant.

III. CARE GUIDELINES (CASE

REPORT)

These are guidelines recommended

by experts around the world for case study

writing to improve the accuracy,

transparency, and quality of reporting so it

is beneficial to all stakeholders. they

include patients, clinicians, researchers,

hey academicians, authors, and medical

journals. Case report writing services

utilise the checklist provided by CARE

guidelines on how to write a medical case

report. These guidelines have been

endorsed time and again and translated in

over 10 languages, hence, best case report

writing services use them extensively. The

checklist broadly consists of title,

keywords, abstract, introduction, patient

information, clinical features, timeline,

diagnostic assessment, therapeutic

intervention, follow up and outcome,

discussion, patient perspective, and

informed consent. The detail checklist is

Copyright © 2020 pubrica. All rights reserved 2

available on their website for help in case

study writing.

IV. PATIENT CONSENT

Reporting a case has its own

challenges, the most important being

protecting the identity and privacy of the

patient. A written, informed, and valid

consent should be taken from the patient or

the guardian prior to reporting the case.

Medical case study report writing need this

prior to publishing diagnostic reports and

images of the patient. Care should be taken

such that the identity of the patient is not

revealed in any form through them.

Consent should be written format always

and should be executed by an authorized

person. The consenting person should be

informed in detail about the risks of being

identified and the measures taken for the

same. Information transmitted to the

consenting person should be transparent,

complete, in a dialect that the patient can

follow, in a simple manner, and impartial.

The consent should be valid implying that

the consenting person is mentally fit to

provide the consent. The terms and

conditions should include whether the final

version of the case report is approved, or

approval is given without seeing the final

version. The patient or the guardian has

every right to consult and have a legal

representative.

Often it may not be possible to

obtain a written, valid consent, and under

these circumstances, one should follow the

legal provisions of that state/country. In

any case, a perfect documentation helps

avoid unnecessary future legal

complications.

V. GENERAL DATA PROTECTION

REGULATION (GDPR)

The GDPR was drafted and passed

by the European Union (EU) on May 25th,

2018 and imposes obligations on all

organizations anywhere in the world data

concerned with collecting and reporting

data related to people in the EU. It is the

harshest privacy and security law in the

world with heavy penalty. GDPR outlines

various articles related to lawfulness of

processing, conditions for consent, and

principles related to processing personal

data. Guidelines related to consent in case

a child is the subject is out lined in article

8. The principles of lawfulness and

fairness require that data processing has its

lawful basis and that participants know

how their data are being processed, as well

as ensuring that processing is aligned with

their expectations. Processing of data for

research purposes is covered in article 9

while article 10 provides guidelines for

processing data related to criminal

proceedings and offenses. Articles 12 to 23

are related to the rights of the data

subjects. There is increased emphasis on

maintaining transparency with the data

subject through appropriate

communication. The right to access of the

data is also outlined here.

GDPR has great significance in

today's world where a lot of data is open

data. Open data includes publication of

research findings on the internet, primary

data in the public domain, and availability

of data to other researchers through

various channels. Data published in the

public domain should be such that human

participants cannot be identified from

it.when research findings describe

cumulative data, individual cases cannot

be identified. However, images and reports

specially of rare outliers could

unintentionally reveal identity of data

subject. Prior written permission for

publication is a must in case participants

can be identified either singularly or by

combination with other data available to

access.

VI. CONCLUSION

To conclude, a proper consent for

publication of case study is to be ensured

and adequately documented from the

Copyright © 2020 pubrica. All rights reserved 2

patients, guardian, legal representatives, or

other relevant authorities.

REFERENCES

1. Roguljić, M., Ščepanović, R., & Rees, M. (2020).

Writing case reports, consent for publication and

General Data Protection Regulation (GDPR). Case

reports in women's health, 27, e00204.

https://doi.org/10.1016/j.crwh.2020.e00204

2. Arpali, E, Akyollu, B, Yelken, B, Tekin,

S, Turkmen, A, Kocak, B. Case report: A kidney

transplant patient with mild COVID‐19. Transpl

Infect

Dis. 2020; 00:e13296. https://doi.org/10.1111/tid.13

296

3. CARECase Report Guidelines. http://www.care-

statement.org/

4. Rees M., Corson S.L. Publication of medical case

reports and consent. Case Rep Womens

Health. 2017 Jul 26;15:A1–A2. doi:

10.1016/j.crwh.2017.07.002.

5. RoguljićMarija, Wager Elizabeth. Case Rep

Womens Health. 2020 April. Consent for publishing

patient photographs; p. 26. e00194.

6. EU General Data Protection Regulation (GDPR)

Available from. https://gdpr.eu/tag/gdpr/

7. Cornock M. How the writers of case reports need to

consider and address consent and the general data

protection regulation (GDPR) Case Rep Womens

Health. 2018;19 e00060.