Informed Consent and Patient Outcomes: An Evidence-Based Analysis

This report delves into the critical issue of informed consent within nursing practice, highlighting its significance in ethical clinical research and patient care. It addresses the complexities of obtaining valid consent, especially when patients have diminished cognitive abilities. The report provides background information on the evolution of informed consent and its importance. It also examines prevalence, risks, and the need for an evidence-based approach to address challenges. The report uses the PICO format to formulate a clinical question and outlines a comprehensive search strategy, including relevant keywords, inclusion/exclusion criteria, and a hierarchy of evidence. It synthesizes findings from five sources, including journal articles, expert opinions, and quantitative studies, to provide recommendations for practice change and further research. The report emphasizes the importance of clear communication, patient understanding, and the role of informed consent in ensuring patient safety and positive health outcomes. The report provides a detailed analysis of informed consent in nursing practice, discussing key issues, risks, and significance of informed consent in clinical practice. This report provides a holistic understanding of the concept of informed consent and its role in clinical practice, including patient experiences and understanding of informed consent. The report also includes the clinical significance of informed consent.

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Evidence based nursing
Outline of Clinical Issue
Brief description
Obtaining informed consent is the cornerstone of clinical ethical research and care. Even though much has been said about the need
and importance of informed consent, it is still difficult to understand the nature, validity and effectiveness of consent. As a concept, it
is difficult to comprehend and even more difficult to implement in clinical practice. Nurses often face a dilemma when treating a
patient who has lost their cognitive skills and as a result is unable to make an informed consent.
Significance of the issue
The need for informed consent arises when the patient or needs to provide health-related information. However, the patient
sometimes is unable to understand the gravity of things and make a hasty decision (Ncbi, 2019). They are required to comprehend
the information given to them and then make an autonomous and informed decision, which the nurses and clinical professionals
have to abide by.
Background information
The concept of informed consent is a recent one and it shows how rapidly has medicine and practice undergone rapid development.
It first appeared in 1957 and does not have clear traces to any medical tradition in history. It was a move to perceive the patient or
the care seeker as an equal partner and the physician’s obligation to inform and educate them about the facts.
Prevalence and incidence rate of the problem
Informed consent can be provided by a person under optimal conditions and without any form of external pressure like that of time or
resources. In case the person is found to be incompetent to consent about their own health decisions, a surrogate is appointed who
is trusted to make decisions on their behalf (Ncbi, 2012). However, it is difficult to decipher when a person is incompetent and then
choose a surrogate who has the best interests of their ward in mind.
Risks involved
Informed consent is a concept that aims to provide the patient information regarding the risks, benefits and complications of their
healthcare procedures or medicines. The care plan or treatment will start if the patient, after comprehending the provided information
agrees to it (Ncbi, 2015). The risk arises in most cases when the patients are not informed about the involved risks and found
themselves in the dark. They later go on to condemn the doctor and their approach (Blease et al. 2016).
Need for using an evidence-based approach
Evidence-based practice approach is varied form the much popular traditional form of practice where work systems continue to be
like they have been without any major changes. Whereas, in evidence-based practice, a clinical problem is solved through research

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Evidence based nursing
and evidence. This is much more scientific and logical rather than basing practice decisions on tradition, intuitions or personal
preferences. It also helps to ensure that the practice patterns are uniform as they are based on scientific evidence.
Clinical Question
Identify your clinical question, using the PICO format
Population How does the chosen intervention plan
impact the population of patients who are
able or unable to make an informed consent?
Intervention How does the use of informed consent benefit
the patient population?
Comparison Why is informed consent preferred to
uninformed or no consent?
Outcome What is the impact of informed consent on the
health outcomes of the chosen patient
population?
Identify the domain
The domain is of human response
Evidence Search
Description of the evidence-based search strategy
The evidence-based search strategy is one where the resources are opted based on the evidence they provide. The PICO questions
were taken as the topics and keywords for search.
Recency of information
The articles or the sources of information were screened on the basis of when the journal was published. Ideally, all the articles have
been published after 2015. As informed consent is recently developed topic hence, it is important to have up to date information
regarding it.
How you narrowed your search to find relevant information

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Evidence based nursing
Broadening or narrowing of searches depends on the availability of information. Since the information was abundantly available, the
scenario was further limited to only clinical practice and issues arising in nursing care. Also, the patient and public understanding of
the concept was included along with the definition of ideal clinical practice as they were thought to be influential for the chosen topic.
Hierarchy of evidence
Types of studies that you considered
appropriate to include
Depending on the nature of the topic
two journals, one expert opinion and two
quantitative studies were chosen. The
nature of the chosen articles was such
as it was important to know the public
and patient ideologies related to the
concept which was gained from two
journals. Whereas the quantitative
studies provide evidence-based
inferences.
Key search terms
Informed consent, informed consent for
clinical treatment, Consent and nursing
scenarios, ideal consent
Key search strategies
Boolean operators “and” was used to
narrow the use of informed consent in
clinical practice.
Inclusion or exclusion criteria that you applied and why
Since the search was narrowed to include only evidence from clinical practice and clinical researches, evidence sources about
clinical researches were ignored. Also, the recency and validity of the sources were considered as an inclusion principle.
Publication types
One clinical guidelines article, two journal articles and two quantitative studies were included.
The rationale for selecting the five sources
Ran
do
mis
ed
tria
l
stu
dyQuantitative
survey study
Clinical guidelines
Editorial journals

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Evidence based nursing
The five sources selected provide a holistic understanding of the concept of informed consent. The role of informed consent in
clinical practice is elucidated in one source, patient experiences and understanding of informed consent have been presented in
another and the clinical significance has also been included.
Literature Synthesis of Best Evidence
SEARCH QUESTION/TOPIC:
Author
(s) (date)
Study
Design
Question
Domain
Key
information
Validity
Check
(eg bias)
Author’s
Results/
Findings
Author’s
Conclusions
Reviewer
Comments
(Your
appraisal)
Evidence Source
No. _1__
Informed consent for clinical treatment Daniel E.
Hall, Allan
V.
Prochazk
a and
Aaron S.
Fink
Purpose:
Summation of
understandin
g of informed
consent in
clinical
treatment
Design:
Editorial
Level: 7
Domain:
Care seekers
P: informed
consent
among
clinical
practice
especially
among
patient having
undergone
surgery
I: Informed
consent
C:
uninformed or
no consent
O: involve
patients in
medical
decision
No bias
has been
reported.
Informed consent
can be interpreted
differently in
different situations.
Simple consent
provides direct
authorization by the
patient or their
surrogate
The
emergence of
informed
consent can
be traced to
many
disciplines
which makes it
difficult to
provide a
comprehensiv
e
understanding.
The article
succinctly
sums up the
evidence
available about
informed
consent in
surgical
patients.

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Evidence based nursing
Evidence Source
No. __2_
Informed consent in clinical practice:
patients’ experiences and perspectives
following surgery
Joseph
Ochieng,
William
Buwembo,
Ian
Munabi,
Charles
Ibingira,
Haruna
Kiryowa,
Gabriel
Nzarubara
and Erisa
Mwaka
Purpose:
The extent of
informed
consent in
nursing
practice
Design:
quantitative
survey
Level: 4
Domain:
Patients from
different
clinical
disciplines
P: patients
from different
clinical
disciplines
I: informed
consent
C:
uninformed or
no consent
O: greater
patient
understandin
g and
involvement
Bias in
choosing
the area
where the
survey
was
conducted
.
Out of 371 patients,
who participates
80% has been
explained about the
procedure and
provided an
informed consent.
Patients
understanding
of what
informed
consent still
continues to
be diverse and
varied.
The result and
finding were
limited and
cannot be used
in context to
public hospitals
as the study
was conducted
in university
teaching
hospital.

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Evidence based nursing
Evidence Source
No. __3_
Attitude towards informed consent practice in a developing country: a community-
based assessment of the role of educational status
Kenneth
Amaechi
Agu,
Emmanuel
Ikechukwu
Obi,
Boniface
Ikenna Eze
and Wilfred
Okwudili
Okenwa
Purpose:
To find the
relation of
ability to
provide
informed
consent with
educational
status of the
patient or the
surrogate
Design:
quantitative
survey
Level: 4
Domain:
randomly
selected
communities
from Nigeria
where
educational
literacy runs
low
P: randomly
selected
communities
from Nigeria
where
educational
literacy runs
low
I: informed
consent
C:
uninformed or
no consent
O: the ability
to be involved
in their own
health and
provide
informed
consent
No
subjectivit
y noticed
in the
article.
Over 70% of the
respondents
regardless of
instructive status
won't leave all
choices about their
social insurance to
the specialist. A
lower extent of
those with no
formal training
(18.5%) will leave
this whole basic
leadership process
in the hands of the
specialist
contrasted with
those with tertiary
instruction (21.9%).
The
examination
demonstrated
that
information of
the educated
assent practice
expanded with
level of
instructive
fulfillment yet
the vast
majority of the
members
independent of
instructive
status would
need to be
engaged with
choices about
their medicinal
services.
This
knowledge can
be used by
physicians to
elicit informed
concepts from
patients.

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Evidence based nursing
Evidence Source
No. ___4
Good clinical practice and informed consent are inseparable
L Doyal
Purpose:
guidelines to
informed
consent is a
part of ideal
clinical
practice
Design:
guidelines
Level: 7
Domain:
clinicians who
dictate the
best interests
of their care
seekers
P: clinicians
who dictate
the best
interests of
their care
seekers
I: informed
consent
C:
uninformed or
no consent
O: the impact
of informed
consent on
ethical
practice
No
subjectivit
y noticed
in the
article.
To put it plainly,
despite the fact that
it might in any case
not—carefully—be
a piece of UK law,
the convention of
educated assent is
ethically and
expertly setting
down deep roots,
and watch this
space as respects
future changes in
the law. This
regulation ought to
be paid attention to
by all clinicians and
medicinal
scientists. Legal
advisors or
bookkeepers
couldn't have an
expert association
with customers who
were reluctant or
unfit to learn and
examine
symptomatic and
prognostic data
about their lawful
and money related
issues.
Contentions
that question
these
establishments
have been
rejected, in
any event in
the terms
wherein they
are generally
displayed. The
genuine
adversary of
legitimate
educated
assent in
medication
isn't the
powerlessness
of grown-up
patients to
take part all
the while.
This article has
laid out great
practice in
getting
educated
assent and
talked about its
good and
lawful
establishments
.

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Evidence based nursing
Evidence Source
No. __5_
Informed Consent
William
Gossman,
Imani
Thornton
and John
E. Hipskind
Purpose:
issues and
significance
of informed
consent
Design:
expert
opinion
Level: 7
Domain:
educated and
informed care
seekers
P: educated
and informed
care seekers
I: informed
consent
C:
uninformed or
no consent
O:
significance
of informed
consent in
practice
No
subjectivit
y noticed
in the
article.
Getting educated
assent in drug is
process that ought
to include: (1)
portraying the
proposed
mediation, (2)
underscoring the
patient's job in
basic leadership,
(3) talking about
options in contrast
to the proposed
intercession, (4)
examining the
dangers of the
proposed mediation
and (5) inspiring the
patient's inclination
(as a rule by mark).
Persistent
wellbeing is a
noteworthy
concentration
in social
insurance, and
compelling
educated
assent is
viewed as a
patient security
issue. The
Joint
Commission
as of late
tended to the
difficulties to
guaranteeing
viable
educated
assent. The
accentuation
of a patient
signature as a
sign of
comprehensio
n is being
raised doubt
about.
The articles
provide the
common
issues, risks
and
significances
related to
consent.
Recommendations for practice change and research
Acquiring informed consent in medicine is process that ought to include: (1) depicting the proposed intercession, (2) underlining the
patient's job in basic leadership, (3) examining options in contrast to the proposed mediation, (4) talking about the dangers of the
proposed intercession and (5) evoking the patient's inclination (normally by mark). Exchange of all dangers is central to informed
consent in this specific circumstance (Spatz et al. 2016). Most consent incorporates general dangers, dangers explicit to the technique,

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Evidence based nursing
dangers of no treatment and options in contrast to treatment. Moreover, many consent structures express that there are no ensures
that the proposed system will give a fix to the issue being tended to (Chima, 2018).
Patient security is a noteworthy concentration in social insurance, and successful informed consent is viewed as a patient wellbeing
issue. The Joint Commission as of late tended to the difficulties to guaranteeing powerful informed consent. The accentuation of a
patient signature as a sign of comprehension is being raised doubt about (Ncbi, 2014). The procedure of informed consent is moving
to concentrate more on correspondence and less on marks. Investigations of informed consent have discovered that there are
numerous hindrances to acquiring powerful informed consent. One noteworthy boundary is that some consent structures contain
language that is at too high a perusing level for some patients (Vargas et al. 2016). Utilization of visual and advanced specialized
devices is being urged to address some the wasteful aspects during the time spent getting consent. Patients ought to be effectively
connected as an approach to improve correspondence and guarantee patient security and comprehension.

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Evidence based nursing
References
Blease, C., Colloca, L., & Kaptchuk, T. J. (2016). Are open‐label placebos ethical? Informed consent and ethical equivocations.
Bioethics, 30(6), 407-414.
Chima, S. C. (2018). An investigation of informed consent in clinical practice in South Africa (Doctoral dissertation).
Ncbi, (2002), Good clinical practice and informed consent are inseparable, Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1766979/
Ncbi, (2012), Informed consent for clinical treatment, Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/
Ncbi, (2014), Attitude towards informed consent practice in a developing country: a community-based assessment of the role of
educational status, Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216367/
Ncbi, (2015), Informed consent in clinical practice: patients’ experiences and perspectives following surgery, Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675036/
Ncbi, (2019), Inforemd consent, Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK430827/
Spatz, E. S., Krumholz, H. M., & Moulton, B. W. (2016). The new era of informed consent: getting to a reasonable-patient standard
through shared decision making. Jama, 315(19), 2063-2064.
Vargas, M., Marra, A., Servillo, G., & Pelosi, P. (2016). Clinical Practice of Informed Consent for Percutaneous Tracheostomy. In
Percutaneous Tracheostomy in Critically Ill Patients (pp. 149-154). Springer, Cham.