SUBJECT INFORMATION AND INFORMED CONSENT TITLE:
CHANGING TRENDS IN ADMISSION PATTERNS IN A NEUROCRITICAL CARE
ICU: INSIGHTS FROM A TERTIARY CARE CENTRE ICU
We are requesting you to take part in a research study of SCTIMST, Trivandrum. We would
like to investigate changes in the trends of the aetiology of neurological disorders over the last
15 years in a tertiary neurocritical care ICU. Your participation will be entirely voluntary and
we would ask you to read and understand this invitation document thoroughly before giving
your consent. This document provides you with all the information you may need for
participation in this study, so that you can make a well informed and considered decision about
participation. In addition, should you have any questions, the doctor and his team members will
be happy to answer them explain to you more about this research study, the procedure involved
and the issues related to it. You may ask them any questions you may have regarding the study,
or ask them to explain any word or information that you don’t clearly understand.
WHAT IS THE PURPOSE OF THIS STUDY?
The main purpose is to analyse the changing trends of the demographic, epidemiological and
aetiological profile of patients admitted to the neurocritical care unit. We hypothesise that the
proportion of patients with immune-mediated neurological disorders (respiratory failure due to
immune-mediated disorders, autoimmune encephalitis) has increased over time, which could be
due to changes in diagnostic techniques, increased awareness of these disorders, or other factors.
We intend to do this study so that we can explore whether there has been a shift in the aetiology
of neurological disorders in the Neuro-ICU over the last 15 years. By focusing on immunemediated neurological disorders, the study could provide insights into the changing
epidemiology of these conditions in the critical care setting, and identify potential risk factors
and management strategies associated with these disorders.
PROCEDURE
Data will be extracted from our case-files in the electronic database(EMR), discharge summaries
and inpatient files. Data on clinical and demographic profiles, aetiology, investigations, treatment
received, complications, duration of hospital stay, and reason for readmission will be collected.
Additional data on imaging findings, electrophysiological test results, and other relevant
laboratory results that helped in confirming the diagnosis will also be collected.
We will document several parameters for each patient, including the time elapsed from admission
to diagnosis, the duration of therapy required for symptom improvement, and their discharge and
follow-up clinical status (based on standard clinical grading for that particular disease, eg: hughes
grading for GBS). Furthermore, we will record detailed information regarding plasma exchange,
intravenous immunoglobulin, monoclonal antibody-based therapies, and any associated
complications. Additionally, we will document any instances of neurosurgical procedures, such as
external ventricular drainage or ventriculoperitoneal shunt placement, as well as the need for
tracheostomy and closure of tracheostomy, along with any ICU-related complications. Lastly, we
will conduct an analysis of specific variables associated with good outcome or bad outcome such
as mortality or prolonged stays in the intensive care unit and prolonged use of mechanical
ventilation.
IS A DRUG BEING TESTED?
No drugs are being tested for this study
BENEFITS
The study will provide insights into the changing landscape of neurological disorders in a highacuity care setting particularly in the context of immune-mediated disorders. Understanding the
trends in the aetiology of neurological disorders is important for clinicians and researchers to
improve patient care and identify areas for further investigation.
RISKS
There are no risks while participating in the study.
VOLUNTARY PARTICIPATION
Your decision to take part in the study is voluntary. You are free to choose not to take part in the
study or to stop taking part at anytime. Even after you decide to take part, you are still free to
withdraw your participation at any time after notifying the study team, without any form of
penalization.
CONFIDENTIALITY
We will respect your and your privacy. The genetic data collected will be kept strictly confidential.
Everything we learn about you in the study will be confidential. They will be assessed only by the study
team, ethical committee and other regulatory authorities. If we publish the results of the study in a
scientific magazine or book, we will not identify you in anyway.
CLARIFICATIONS
If you have questions any regarding this, feel free to ask us. If you have additional questions
later or you wish to report a medical problem which may be related to this
study................................... The SCTIMST committee that reviews research on human subjects
(Ethics Committee detailed as below) will answer any questions about your rights as a research
subject.
We will give you a signed copy of this form to keep.
INFORMED CONSENT
By signing this form, I agree that:
1) You have explained this study to me. You have answered all my questions.
2) You have explained the possible benefits and harms (if any) of this study.
3) I understand that I have the right to refuse to take part in the study. I also have the right to
withdraw from the study at any time. My decision about taking part in the study will not
affect my health care at the institute.
4) I am free now, and in the future, to ask questions about the study.
5) I have been told that my medical records will be kept private. You will give no one
information about my illness unless the law requires you to.
6) I have read and understood this consent form.
I give my consent for taking part myself________________take part in this study.
.
Printed name of Patient/Bystander
_________________________________
Signature & date
_______________________________________
Printed name of person who explained consent form
_________________________________
Signature & date
_______________________________________
Printed name of witness (if the patient/ bystander
does not read English/Malayalam)
__________________________________
Witness’ signature & date