Evidence based Practice

Prepared By
Bareera Saeed
Senior Lecturer(PhD Scholar)
Department of Rehabilitation Sciences
Faculty of Allied Health Sciences
 Ethical considerations
Learning objectives
Students will be able to know about what are
ethics in research
Students will be able to know all the ethics
that are required to follow in research
Students will be able to know about PEDRO
scale

3
Ethics
Ethics refers to a moral philosophy or a set of moral
principles that determine appropriate behavior in a
society.

The term ethics refers to a set of moral principles that

determine what is right, good, virtuous, true, and
just,as defined by a culture or society. In a civilized
society, these moral principles govern the conduct of
individuals or group with respect to others.
Code of Ethics
A Code of Ethics is an official statement of beliefs and
guidelines of a professional group that reflects the
responsibilities, obligations, and goals of the group’s
members.
It serves to guide the professional behavior of members by
determining the values that the profession considers
important to its identity.
Furthermore, a code identifies behaviors that support those
values and the behaviors that erode them.
APPLYING ETHICAL PRINCIPLES IN
HEALTH CARE
Although a professional or organizational Code of Ethics
provides general principles of behavior based on certain
values, medical and health care professionals need to go
beyond knowing the general rules to having a deep
understanding of the concepts behind the rules.

To do so, they need their own moral values, including

honesty, integrity, and a commitment to ‘‘doing the right
thing.’’ This is important so that the professional is able to
apply the rules in real-world situations.
APPLYING ETHICAL PRINCIPLES IN HEALTH
CARE
Health care professionals always have the ethical
responsibility to act in the best interest of the patient.

In addition to the standard moral and practice values

published by ASHA and other professional
organizations, there are additional values that are
pertinent to medical ethics in both clinical care and in
research.
APPLING ETHICAL PRINCIPLES IN HEALTH
CARE
These principles include the following:

Autonomy
Beneficence
Non-maleficience
Justice
Dignity
Truthfulness and honesty
Autonomy
The value of autonomy refers to the patient’s (or the guardian’s) right
to be actively involved in making decisions about his or her own
medical care.
 This ethical value has received more focus over the past few
decades, resulting in a gradual shift in the nature of patient physician
relationships.

Respect for the patient’s autonomy is one reason for the requirement
of ‘‘informed consent’’ prior to initiating treatment. Placing a high
value on patient autonomy has resulted in patients and families
becoming much more active members of their own health care teams
Autonomy
This value is also the basis of a relatively new philosophy in health
care called ‘‘family-centered care”, which focuses on partnerships
between the health care providers and the patients/families.
In regards to autonomy, speech-language pathologists (SLPs) have
a responsibility to engage the patient/family in the therapeutic
process by ensuring that they understand the diagnosis,
recommendations, treatment goals, and specific strategies for
working on the goals at home.
 The concept of family-centered care is particularly pertinent in
speech-language pathology. It can be said that providing speech
therapy without the active involvement of the family and frequent
practice at home is no more effective than taking piano lessons and
not practicing between lessons
Beneficence
Beneficence is a core value of health care because it
involves actions that result in the well-being of others.
The health care professional has the ethical
responsibility to act in the best interest of the patient at
all times.

In fact, the primary goal of health care is to benefit the

health of the patient. Therefore, many health care
providers consider this as the most important value in
ethical decision making.
Beneficence
The concept of beneficence is obviously important in
speech-language pathology. Our overarching goal is to
help the patient to improve functional abilities in
communication and/or feeding and swallowing.
We tend to take for granted that what we do makes a
positive difference for the patient. It has become clear
that professionals need to use the scientific method to
prove efficacy, and thus the beneficence, of their
methods. This has cultivated a strong focus on
evidence-based practice (EBP) as the standard in
health care.
Non-Maleficence
The word maleficence means doing harm or evil. The
concept of non-maleficence, therefore, is best
described by the phrase ‘‘first do no harm”. This is also
an important value in health care.
Prior to recommending a treatment, the health care
practitioner must be reasonably sure that the patient
will benefit from the treatment and that the expected
benefits far outweigh the risks of harm. Most hospitals
have a risk management program to ensure non-
maleficence as much as possible.
In speech-language pathology, it is easy to be cavalier about the concept
of nonmaleficence.
Situations that could potentially cause harm include the following
examples:

Feeding a medically compromised infant without adequate training in

feeding/swallowing.
Recommending surgery for velopharyngeal insufficiency or a voice
disorder without the proper knowledge.
Keeping a child in therapy, despite a lack of documented evidence of
progress, resulting in inconvenience and expense to the family or
society.
Continuing to work on speech for years, when the child could have
benefitted from an augmentative communication device.
Putting a child in speech therapy for hyper- nasality, when this disorder
requires surgical intervention
Non-maleficence
It is certainly an ethical responsibility of all SLPs to
make sure that their recommendations and
interventions are made based on adequate knowledge
and evidence to avoid causing harm or even
inconvenience for the patient and family.
Justice
Justice in medical settings refers to the rights of all
individuals to have equal and fair access to health care
resources. In a society where not all citizens have access
to health care insurance, this value is often an ethical
challenge for health care organizations and providers.

In addition, the patients’ rights movement over the last

few decades has swung from ‘‘the perception that the
right of self-determination extends not only to the refusal
of medical treatments, but to demands for overtreatment.’
Justice
In pediatric speech-language pathology, parents often
request a particular type, intensity, or setting for their
children’s treatment that the SLP would not consider
appropriate or potentially beneficial.
This is a particular problem in cases where, for example, a
child is not making progress in therapy and has a poor
prognosis, yet the parents want to increase the frequency of
therapy. Parents, when they believe they are acting in their
child’s best interest, are understandably not receptive to
discussions of distributive justice and the scarcity of
resources when it affects their child’s access to service and
impacts their hope for the child’s progress.
Dignity
The value of dignity relates to the basic human rights of the
patient and family, which should be observed while they are
being served in a health care setting.
Many hospitals and health care facilities develop, post, and
distribute a list of patients’ rights for their organizations.
These may include:
 The right to be treated with respect and dignity.
 The right to ask questions.
 The right to be involved in the treatment decision making
and to refuse treatment if desired.
 The right to access the medical record.
 The right to privacy and confidentiality
Dignity
In considering the ethical value of dignity, SLPs
should be particularly diligent about privacy,
confidentiality, and security of the patient’s health care
information.
 Keeping protected health information confidential is
essential in providing clinical service and conducting
research.
Truthfulness and Honesty
Truthfulness and honesty are important in the
communication between the health care provider and
the patient and/or family so that they have sufficient
information to make their own health care decisions.

A truly ‘‘informed’’ consent can only be given if the

patient/family has a thorough understanding of the
facts, implications, and future consequences of a
proposed treatment. The importance of truthfulness
and honesty in dealing with patients is obvious.
PEDRO Scale
What is the PEDRO scale

Clinical trials indexed on the Pedro database are rated

with a checklist called the "PEDro scale"
Developed to help the users of the PEDro database to
rapidly identify clinical trials that are likely to be
internally valid and have sufficient statistical
information to make their results interpretable
The PEDro scale considers two aspects of trial quality,
namely the
1. Believability / Internal Validity (Item 2-9)
2. Whether The Trial Contains Sufficient Statistical
Information To Make It Interpretable (Items 10-11)
 ITEM: 1 Eligibility criteria and source
Criterion: This criterion is satisfied if the report describes
the source of subjects and a list of criteria used to
determine who was eligible to participate in the study.
PEDro scale item 1 relates to external validity or
generalisability, but not the internal validity or statistical
reporting of the trial. Because it does not evaluate internal
validity or statistical reporting it is not included in the PEDro
score.
To fulfill this item the report needs to describe BOTH the
source of subjects AND the eligibility criteria used to select
subjects. If only one aspect is described it would score a
‘no’
ITEM 2: Random Allocation

Criterion: Subjects were randomly allocated to groups

A study is considered to have used random allocation
if the report states that allocation was random.
The precise method of randomization need not be
specified.
Procedures such as coin-tossing and dice-rolling should
be considered random.
Quasi-randomization allocation procedures such as
allocation by hospital record number or birth date, or
alternation, do not satisfy this criterion.
ITEM 3: Concealed Allocation

Criterion: Allocation was concealed

Concealed allocation means that the person who
determined if a subject was eligible for inclusion in the
trial was unaware, when this decision was made, of
which group the subject would be allocated to.
A point is awarded for this criteria, even if it is not
stated that allocation was concealed, when the report
states that allocation was by sealed opaque envelopes
or that allocation involved contacting the holder of the
allocation schedule who was “off-site” or “not
otherwise involved in the study”.
Concealment of allocation is “the process used to
ensure that the person deciding to enter a participant
into a randomized controlled trial does not know the
comparison group into which that individual will be
allocated.

This is distinct from blinding, and is aimed at

preventing selection bias”
ITEM 4: Baseline comparability

Criterion: The groups were similar at baseline regarding the

most important prognostic indicators
At a minimum, in studies of therapeutic interventions, the
report must describe at least one measure of the severity of
the condition being treated and at least one (different) key
outcome measure at baseline.
The rater must be satisfied that the groups’ outcomes would
not be expected to differ, on the basis of baseline differences
in prognostic variables alone, by a clinically significant
amount.
This criterion is satisfied even if only baseline data of study
completers are presented.
ITEMS 5, 6 AND 7:
Blinding of subjects, therapists and assessors

These three items on the PEDro scale deal with

blinding or masking, and will be considered together.
Criterion 5: There was blinding of all subjects
Criterion 6: There was blinding of all therapists who
administered the therapy
Criterion 7: There was blinding of all assessors who
measured at least one key outcome
 Blinding means the person in question (subject, therapist or
assessor) did not know which group the subject had been
allocated to.
 Blinding of subjects involves ensuring that subjects were
unable to discriminate whether they had or had not
received the treatment
 Blinding of therapists involves ensuring that therapists were
unable to discriminate whether individual subjects had or
had not received the treatment
 Blinding of assessors involves ensuring that assessors were
unable to discriminate whether individual subjects had or
had not received the treatment
 Reports sometimes use the terms single-blind, double-blind
and triple-blind. The problem with using these terms is that
there are no accepted definitions, so that the same terms
ITEM 8: Adequate follow-up

Criterion: Measures of at least one key outcome were obtained

from more than 85% of the subjects initially allocated to groups
In trials in which outcomes are measured at several points in
time, a key outcome must have been measured in more than
85% of subjects at one of those points in time.
The rater needs to judge which outcomes are key outcomes and
which follow-up periods are key follow-up periods.
The cut-off is 85%, so if ≤ 85% of subjects initially allocated to
groups have data for a key outcome at follow-up the record will
score a ‘no’ for this item while if > 85% of subjects initially
allocated to groups have data for a key outcome at follow-up will
score a ‘yes’.
ITEM 9: Intention-to-treat analysis
Criterion: All subjects for whom outcome measures were
available received the treatment or control condition as
allocated or, where this was not the case, data for at least one
key outcome was analyzed by “intention to treat”
An intention-to-treat analysis means that, where subjects did
not receive treatment (or the control condition) as allocated
and where measures of outcomes were available, the analysis
was performed as if subjects received the treatment (or control
condition) they were allocated to.
This criterion is satisfied, even if there is no mention of analysis
by intention to treat, if the report explicitly states that all
subjects received treatment or control conditions as allocated.
ITEM 10: Between-group comparisons

A between-group statistical comparison involves statistical comparison

of one group with another.
Depending on the design of the study, this may involve comparison of
two or more treatments, or comparison of treatment with a control
condition.
The analysis may be a simple comparison of outcomes measured after
the treatment was administered, or a comparison of the change in one
group with the change in another.
The comparison may be in the form of hypothesis testing (which
provides a “p” value, describing the probability that the groups differed
only by chance) or in the form of an estimate (for example, the mean
or median difference, or a difference in proportions, the number
needed to treat, a relative risk or a hazard ratio) and its confidence
interval.
ITEM 11: Point estimates and variability

Criterion: The study provides both point measures

and measures of variability for at least one key
outcome
A point measure is a measure of the size of the
treatment effect. The treatment effect may be
described as a difference in group outcomes, or as the
outcome in (each of) all groups. 
Measures of variability include standard deviations,
standard errors, confidence intervals, interquartile
ranges (or other quartile ranges), and ranges.
For continuous data, the type of point estimate (e.g.,
mean or median) and the type of variability (e.g.,
standard deviation or standard error) needs to be
specified.
For categorical data (e.g., ‘able to walk
independently’ versus ‘not able to walk
independently’), this criterion is achieved if the
number of subjects in each category for each group
are reported.
Reference
https://
www.sagepub.com/sites/default/files/upm-binaries/499
9_Polonski_Chapter_5.pdf
https://research-methodology.net/research-methodolog
y/ethical-considerations
/
https://pedro.org.au/wp-content/uploads/
PEDro_scale.pdf
Learning Outcomes
Students have learnt about
What are ethics in research
Ethics that are required to follow in research
PEDRO scale