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EVIDENCE BASED

PHYSIOTHERAPY MODULEs

Published by:
College of Physiotherapy
Sumandeep Vidyapeeth University,
Piparia, Waghodia, Vadodara.
2016

FIRST
[Type text]
EDITION
FIRST EDITION

EVIDENCE BASED
PHYSIOTHERAPY
MODULES

Published by:

College of Physiotherapy, Sumandeep Vidyapeeth, Piparia, Vadodara- 391760

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PREFACE

The commitment to evidenced based practice (EBP) emerges as the need of the hour. Use of
EBP is believed to be an important means by which physiotherapists can deliver safe and
effective interventions, avoid use of ineffective and potentially detrimental methods, and thus
avoid wasting precious resources which are allocated to healthcare. Early education on the
foundations of EBP is advocated as a potent intervention toward enhancing EBP uptake among
physiotherapists.

The World Confederation for Physical Therapy (WCPT) strongly advocates teaching the
principles of EBP in undergraduate physiotherapy curricula. This booklet is an attempt to
provide an introduction to the skills required for evidence-based practice for undergraduate
students. We hope that this book serves to be a useful resource /guide for the UG students
providing them with details on strategies for searching for evidence, critically appraising the
evidence ultimately integrating & communicating the evidence to the various stake holders.

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INDEX

Chapter Title Page No.

1 Introduction to Evidence Based Practice 4

2 Development of Evidence Based knowledge 9

3 Searching for the Evidence 12

4 Steps of Evidence Based Practice 16

5 Overview of Research Design 25

6 Levels of evidence 35

7 Statistics 38

8 The Cochrane collaboration 42

9 Outcome Measures 43

10 Critical Appraisal 48

11 Communicating evidence to clients, managers and funders 75

12 Inferential statistics 77

13 Economic evaluation 82

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Chapter – 1 INTRODUCTION TO EVIDENCE BASED PRACTICE

What is Evidence?

 Evidence is thought as ‘proof’ supporting a claim or benefit.


E.g. Bill is the evidence of the things what we purchase.

Purchase bill is the evidence of the products purchased from the grocery shop. If you do not
show purchase bill at exit door of a mall, then you will not be allowed to go out and it will
be thought as you have stolen the goods.

Today we live in an age of evidence. Whether it is the teaching or evaluation process or it is


research, the element of evidence needs to be integral to the entire process.

Exercises:

1. Write down evidences required when you took admission in physiotherapy.


2. What evidence/proof was required to appear in the exam hall during 12th board exam?
3. Name the evidence required to travel in bus or train.
4. What evidences are required when you want to purchase SIM Card?
5. What evidences are required when you want to open a Bank Account?

Assignment:

1. List down 10 different evidences required in day to day living.

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Evidence Based Practice

Brief History: The roots of evidence-based practice are in evidence-based medicine. In 1972,
the importance of properly testing the effectiveness of health care strategies, to provide
evidence on which health care is based was initiated. Later in 1992, the term "evidence-based
medicine" was introduced by Dr. Gordon Guyatt which was further explained by Dr. David
Sackett in 1996as a combination of not only research evidence but also clinical expertise (expert
opinion), taking into account the patient’s preferences (choices). Since then, evidence-based
decision making has been widely accepted by allied health areas and David Sackett is called as
the father of evidence-based medicine.

Dr. David Sackett

Definition by David Sackett, EBP is “the conscientious, explicit and judicious use of current best
evidence in making decisions about the care of the individual patient. It means integrating
individual clinical expertise with the best available external clinical evidence from systematic
research”

Conscientious - to do something well and thoroughly

Explicit - stated clearly and in detail without confusion

Judicious - done with good judgement or sense

Evidence Based Practice in Medical and Physiotherapy

Let’s understand with an example: You are suffering from common cold. You think to have a
medicine to get relief from cold. But there are many medicines available in the market for

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common cold. So before purchasing tablet you will take opinion of your parent or friends about
which tablet gives fast recovery from cold or which tablet gives good results from cold. Once
you know that then only you will purchase that tablet. Many of them suggest that tablet X gives
good results. So, the evidences stating that tablet X must be taken to get relieve from common
cold is based on their individual experiences.

Evidence Based Physiotherapy Practice

Evidence Based Physiotherapy Practice is when a therapist makes a clinical decision about the
physiotherapy management of a patient, by proper steps taken to arrive to a conclusion,
knowing the rationale (reasons) behind the decision, giving a thought for what will be the
positive / negative impact of such clinical decision on patient and also integrating patient’s
preferences (choices) and values.

For e.g. a female patient with back pain comes to physiotherapy department to take the
treatment. After following the appropriate steps and arriving at conclusion that massage is very
useful in reducing pain and spasm in low backache patient. So, therapist decides to include
massage in the treatment after giving a thought of its positive impact on the patient. But
patient prefers to take massage therapy from a female therapist rather than a male therapist
due to her social values. So, the therapist has to respect the choice (preference) of the patient
before giving treatment.

We need to study Evidence Based Practice to support our decision –making, So that our
decisions are based on best available evidences and that can be applied on patients which will
benefit them in the best way.

Exercise:

1. After completion of your 12th standard, you wanted to join physiotherapy course. But
there are many colleges in Baroda and other cities. Describe the reliable information
you collected for joining college of physiotherapy, Sumandeep University.

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Concepts of EBP:

Awareness, Consultation, Judgment and Creativity

 Awareness: It is the state or ability to perceive, to feel, or to be conscious of events, or


objects.

E.g. 1: 2016 Olympics were held in Rio de Janeiro, Brazil.

E.g.2: Students are aware of government Shishyavrutti program.

 Consultation: It is the process of formal discussion.

E.g. 1: A meeting with an expert in order to seek advice.

E.g. 2: Before joining physiotherapy in Sumandeep Vidyapeeth, you might have


consulted many people.

 Judgment: It is the process of arriving at conclusion or decision based on relevant


evidences.

E.g. 1:Court judgment, purely based on the evidence presented by lawyer.

 Creativity: It is a phenomenon where by something new and valuable is created (such as


an idea, an artistic or literary work). It is the act of turning new and imaginative ideas
into reality.
E.g. 1: Famous story of THIRSTY CROW.

Single example for Awareness, Consultation and Judgment: After passing 12 th standard, you
wanted to join physiotherapy course. So you must have searched number of colleges available
in Baroda offering the same course (i.e. you must be aware that there are many colleges which
are functioning as physiotherapy colleges).After making list of different colleges, you started
consulting others for a suggestion on Physiotherapy College for admission (i.e. consultation)
and after getting positive reviews on college, you decided (i.e. Judgment)to join college of

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physiotherapy, Sumandeep Vidyapeeth University after judging all the positive aspect of how
the college may give you best education and built a strong career.

Assignment:

1. Write down how evidences are disclosed in a court case of robbery?

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Chapter – 2 DEVELOPMENT OF EVIDENCE BASED KNOWLEDGE

Development of Evidence Based Knowledge in the Individual Professional and within a


Discipline

Development of EBP is necessary for safety and quality improvement in health care.

Patient safety practices are those that reduce the risk of adverse (harmful) events related to
exposure to medical care across a range of diagnoses or treatment.

E.g. 1: Use of pressure – relieving bedding material to prevent pressure ulcers.

E.g. 2: Bar coding to avoid patient safety errors and thus improves health care process.

[Pressure – relieving bedding] [Bar codes]

Evidence Based Knowledge in health care - it is the cornerstone of Evidence Based Practice and
its main aim is to provide quality health care to the patients by various methods like
demonstration of health-promoting behaviors, etc.

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E.g. 1: Dettol advertisement

E.g.2: During Swachata week (on Gandhi Jayanti), students of college of physiotherapy
demonstrated Hand sanitization technique (proper hand washing technique) to the students,
patients and their relatives for health promoting behaviors.

[Demonstration of Hand Washing Technique]

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Development of Evidence Based Knowledge in the Professionals across Disciplines

There are increasing evidences stating that EBP can help healthcare professionals to improve
patient care quality. The backgrounds of different medical and allied health care professionals
naturally differ. Weng et al (2013) found important differences regarding EBP across the
professional groups. The important discrepancies across the profession which he found to be
wide enough were awareness of EBP, beliefs, attitudes toward EBP, knowledge of, skills in,
barrier to and behavior regarding EBP. He found that physicians and pharmacists were most
aware of EBP due to long history of exposure to and efforts to influence the use of EBP compare
toother fields. So the need to develop evidence based knowledge in the professional across
disciplines is necessary.

How to develop evidence based knowledge?

Positive perception - Active participation to learn Evidence Based Practice, not with the attitude
to avoid learning. E.g. searching for the evidence with curiosity when you face a particular
problem/question/patient condition.

High self-efficacy- To believe in own ability that you can do Evidence Based Practice.

Educational training - Tutorials, Seminars, Workshops.

To develop the knowledge of EBP across the professional groups, education and training to
some extent will increase positive beliefs as the confidence of the individual will increase and
this will result in change in the attitudes regarding EBP and thus will ultimately increase use of
EBPin practice.

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Chapter – 3 SEARCHING FOR THE EVIDENCES

The rapid development of the Internet in recent years has made it a first choice for searching
information. The internet can provide access to information on all kinds of topics, of varying
quality and usefulness. The most frequently used source for evidence are search engines.

What is Internet Search Engine?

• According to Wikipedia ‘it is a software system that is designed to search for information
on World Wide Web [www.] ’

• Search engines enable you to find the information on a particular topic via the Internet
using a word or phrase.

• Search engines operate by creating and then searching a locally indexed database of
web pages.

Following are the name of common search engines for finding information including scientific
articles.

• GOOGLE

• YAHOO

• BING

• ASK.COM

In these search engines, information is searched using specific keywords.

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What are keywords?

Regardless of what question you are seeking answers to or in which search engines we are
looking in to, you need to select search terms. Selecting search terms/keywords is to specify
words that tell the search engine what we are searching for.

A poorly constructed search may results in thousands of results (relevant or irrelevant to topic
of search) or none at all while searching in a search engine. Therefore, search terms/ keywords
should be carefully selected.

For E.g. “The effect of diet as a risk factor for cancer”

Here the keywords should be ‘Diet’, ‘Risk factor’ & ‘Cancer’. Also look for the alternating terms
that can be used to describe each of the keywords. As in above example, ‘Diet’ can be the
alternating term for ‘Food’.

What are the BOOLEANS?

Search for evidences/articles also gets specific by using Booleans during search in the search
engine.They are for literature searches that allow the user to refine and extend the terms of the
search. To combine different concepts in a search, you have to use Boolean operators. These
are logical operators that enable you to broaden or restrict a search.

 The main operators are ‘OR’, ‘NOT’ & ‘AND’.


e.g. 1 Diet OR Cancer
In this example, using the OR operator will retrieve all article which mentions Diet OR
Cancer.

Diet Cancer

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e.g. 2 Diet AND Cancer
In this example, using the AND operator will retrieve all articles which mentions Diet
AND Cancer.

Diet Cancer

e.g. 3 Diet NOT Cancer


In this example, using the NOT operator will retrieve all article which mentions Diet NOT
Cancer.

Diet Cancer

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References:

1. Yi-Hao Weng et al. Implementation of evidence-based practice across medical, nursing,


pharmacological and allied healthcare professionals: a questionnaire survey in
nationwide hospital settings. Implementation Science. 2013; 8:112.
2. Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 1.
3. Chad Yates. Evidence-Based Practice: The Components, History, and Process. Counseling
Outcome Research and Evaluation. 2013; 4(1) 41-54.
4. Best Practices for Hand Hygiene. In All Healthcare Settings and Programs. British
Columbia Ministry of Health; 2012.
5. Dianne V. Jewell. Guide to Evidence Based Physical Therapy Practice. Jones and Bartlett
Publishers. 2008.
6. Alison Brettle and Maria J. Finding the Evidence for Practice. Churchill Livingstone, 2004.

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Chapter – 4 STEPS OF EVIDENCE BASED PRACTICE

Health care professionals like physicians, therapists and nurses are taught on how to diagnose
and treat patients during their formal training in colleges and once they start to work they will
simply try to keep up their workload to treat patients the best they know how. It is a
challenging task to unlearn what one has learnt or to adopt to a new model of health care
delivery. It is difficult to incorporate Evidence Based Practice (EBP) for a busy health care
professional as it is also time consuming. There are five steps that will help a busy health care
professional to incorporate EBP into their practices to reduce the time consumption and to
learn how to effectively use EBP.

Step 1: ASK a clinical question to identify a key problem.


Step 2: ACQUIRE the best evidence possible
Step 3: APPRAISE the evidence
Step 4: APPLY the evidence to daily clinical practice.
Step 5: ASSESS the outcome of evidence

FIG – 5 STEPS IN EBP (5 As in EBP)

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Step 1: ASK a clinical question to identify a key problem.

In our daily practice we do ask ourselves many questions like


 How many patients do I see every day?
 What are some of the most common conditions prevalent among my patients?
 Why do some people have a particular condition whereas others do not?
 Why do some people respond to particular treatment and others do not?
 Am I using the best treatment method available?
 How can I improve my treatment?
 How effective is my treatment?
 How do I demonstrate the effectiveness of my service?
 How satisfied are my patients with my treatment?

Though we may ask ourselves many questions we may not try to find answers for all our
questions. Pursuing answer for a question depends on many factors like importance of such
question in our practice, availability of Time and resources, are we regularly getting answers for
our questions which helps us to keep up our motivation, out interest in finding an answer and
lastly do we have the patience to pursue an answer.

The types of information needs that arise regularly from our clinical practice are those
questions such as Why do we do it this way? or What's the best way of ....? for which we
generally don’t have a ready answer.

For example, using pain diaries is a common practice, especially in a palliative care, and
considered to be useful. One can also argue that monitoring one's pain in a diary actually
heightens one's awareness and experience of pain so pain diaries can do harm rather than
useful. Now we really don’t know completing pain diaries are useful or harmful and we need to
search the literature to find out if there was any such research.

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Questions are generally typified into structured, semi structured and unstructured questions. A
Structured question is a question that is pre decided, follows a pattern and tries to find a
specific information as an answer. Structured question is carefully and thoughtfully formed so
that the search for evidence is easier. The structured question makes it relatively
straightforward to elicit and combine the appropriate terms needed to represent the need for
information in the query language of whichever searching service is available to us.

One of the fundamental skills required for practicing Evidence based practice is the asking of
well-built / structured clinical questions. To benefit patients and clinicians, such questions need
to be both directly relevant to patients’ problems and phrased in ways that direct your search
to relevant and precise answers. Framing the question in a way which lends itself to searching
while still reflecting the specific patient or service focus is an important stage to get right. That
way, when we begin searching for evidence on the topic we have chosen, the volume of
research will be manageable.

Before beginning to hunt for evidence, we need to spend some time making the questions
specific since structuring and refining the question makes it easier to find an answer. A
structured question for the above pain diary example would be: does the use of pain diaries in
the palliative care of patients lead to improved pain control?

But it’s not often easy to convert a clinical scenario in to a structured question. One way to
structure a question is to break the problem into parts. We usually break questions about the
effects of intervention into four parts or sometimes into five also.

P Patient or problem or population


I Intervention or Indicator
C Comparison (optional, if relevant)
O Outcome of interest

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Formulate the question with PICO. Sometimes PICO can be expanded to include T which stands
for Time or Type of study, in such situation it is known as PICO (T).

E.g,
P – Palliative care patients
I – Pain diary
C – No comparison or other pain history methods
O – Improvement in pain control

While constructing a PICO one should remember the following;


P Patient, Population, or How would I describe a group of patients similar to
Problem mine?
I Intervention Which main intervention, prognostic factor,
or exposure am I considering?
C Comparison What is the main alternative to compare
with the intervention?
O Outcome you would like to What can I hope to accomplish, measure,
measure or achieve improve, or affect?

Constructing a PICO for a given clinical scenario improves the usefulness of questions to find a
correct answer.

PICO format makes our questions into


 More clear and focused
 Reduces the confusion
 Makes it Searchable (Key words)
 Makes our questions and searches as easily communicable
 Overall, it improves the QUALITY of our questions!!!

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Exercises:
Construct PICO for the following scenarios.
1. Does hand washing among healthcare workers reduce hospital acquired infections?
2. What is the effectiveness of restraints in reducing the occurrence of falls in patients 65 and
over?
3. "Is there evidence to suggest that the prophylactic use of vitamin B12 supplements is
effective in improving the quality of life (specifically cognition) of apparently healthy older
people?"
4. A friend of yours (Non Medical person) wants to discuss the possibility of a vasectomy. He
says he has heard something about vasectomy causing an increase in testicular cancer later in
life. You know that the risk of this is low but want to give him a more precise answer.
5. A 56 year old patient is osteoarthritis of right knee comes for Physiotherapy treatment.
Studies have shown that giving heating modality along with strengthening exercises improves
patient’s functional status faster than only strengthening exercises.

Step 2: ACQUIRE the best evidence possible

Once we converted our clinical scenario into a PICO format question, then the next step is to
use this PICO as keywords and search for the evidences. Evidences can be obtained as expert
opinions and also in text format from Text Books, Journals and also through Internet (search
engines, data bases) etc.

Before moving further it is important to learn certain terminologies

What is an Article?
Generally it is a piece of writing included in a magazine or newspaper. A scientific article is
written by scientists for a scholarly audience. A peer-reviewed journal article means that the
article's scientific quality has been checked by other scientists before publication.

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What is Journal?
In academic publishing, a scientific journal is a periodical publication intended to further the
progress of science, usually by reporting new research.It is a scholarly publication containing
articles written by the researchers, professors and other expertise. Journals are likely to provide
more up-to-date information than books. Journals can also, in addition to scientific articles,
include other types of articles such as book reviews, opinion articles and commentaries.There
are many journals available in library both in Printed and electronic versions.
For e.g.: Journal of Orthopaedic & Sport Physical Therapy (JOSPT), Physical Therapy Journal, etc.

What is Reference?
Detailed description of the document from which you have obtained your information. For e.g.
reference given at the end of the book.

What is search engine?


A web search engine is a software system that is designed to search for information on the
World Wide Web. Some popular search engines are Google, Yahoo, Ask.com and Bing etc.
A search engine searches enormous databases of Web pages, using titles, keywords or text.

Advantages of a general search engine are


1. The indexes of search engines are usually vast
2. representing significant portions of the Internet
3. offering a wide variety and quantity of information resources including Pubmed
4. Find something
5. Results appear to be organized
6. Fast

Disadvantages of a general search engines are


1. Irrelevant web pages
2. Commercial

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3. No ranking of results
4. Involve a learning curve

What is a database?
Database is an organized way of collection of data. Databases allow us to efficiently search for
published information such as journal, magazine, and newspaper articles. Databases can be
general (all disciplines) or discipline-specific (e.g. a physiotherapy database - PEDro). Since
databases are collection of scientific articles they are considered to give us relevant and reliable
answers to our questions. Some of the databases are

• Medline / PubMed
• CINAHL (Cumulative Index to Nursing and Allied Health Literature)
• PEDro
• TRIP database
• Cochrane library
• Uptodate
• Embase
• ProQuest
• Scopus
• EBSCO

When I should use a search engine and when I should use a database?
It depends on what type of information we are hoping to find and how we plan to use it. If we
want credible, scholarly articles, we will have more success finding relevant sources in a
database. If we want Census data, it is more efficient to find that through a search engine that
guides us to the appropriate government website.

Once we have a PICO (T) in our hand it is essential to decide which type of study we are looking
for and to decide the database that we will be using to search the evidence.

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Step 3: APPRAISE the evidence
It is the process of systematically examining research to assess the value and trustworthiness of
the evidence. Once the evidence has been identified (article), it has to be assessed to know its
relevance to the original question, its quality etc. A health care professional should ask many
questions while appraising an evidence, keeping in their mind about the original question they
asked (the question that was converted into PICO format). Appraising the evidence has been
dealt in detail in the future sections in this book.

Step 4: APPLY the evidence to daily clinical practice.


If the evidence passes the appraisal step and adds value to the practice, then health care
professional can incorporate the new knowledge into their daily clinical practice. It’s important
to note that EBP doesn’t replace a clinician’s expertise or judgment. Its purpose is to enhance
their ability to make better care decisions based on the needs and preferences of the patient.

Step 5: ASSESS the outcome of evidence


Even with treatment that has the plenty of evidence, evaluation of the application in practice is
necessary. Perfect results are never guaranteed, and that’s why evaluating the treatment is
very important step in evidence based practice. Systematic and careful monitoring and
evaluation should be done of the treatment which is implemented.

EBP does not stop at assessing the outcome of evidence. EBP is an ongoing process—
reassessing and re-measuring any gains or losses should be part of an ongoing cycle to ensure
the best outcomes.

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Fig. EBP Process

Exercises:
1. Describe all the steps for searching an evidence on effect of resisted exercise on
improving strength of muscles.
2. Search for any two evidences on massage using all the steps.

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Chapter – 5 INTRODUCTION TO RESEARCH DESIGN

Research an integral part of Practice


Research is considered as a way of thinking. It is a habit of questioning what we do. Research is
examining critically the various aspects of our day to day professional work. Research helps us
in understanding and formulating guiding principles that govern a particular procedure. It also
helps us in developing and testing new theories that advance our practice and profession. It is a
systematic examination of clinical observation to explain and find answers for what we
perceive. In other words – Research is an Integral part of our practice.

What is Research?
Two syllables – Re and Search
Re – a prefix meaning again, anew or over again
Search – a verb meaning to examine closely and carefully, to test and try or to probe
Together Research is a Noun describing a careful, systematic, patient study and investigation in
some filed of knowledge, undertaken to establish facts or principles

Definition: Research is a structured inquiry that utilizes acceptable scientific methodology to


solve problems and creates new knowledge that is generally applicable (Grinnell).

Research is an Organized and Systematic way of finding answers of questions.


Organized - is a structured. It is a planned procedure, not a spontaneous one.
Systematic - is a definite set of procedures and steps which will be followed.

Types of Research
 Qualitative research: - Qualitative studies focus on subjects’ thoughts, perception,
opinions, beliefs and/or attitudes. Data are provided in words rather than in numbers
through interviews, surveys, diaries. E.g. Feedback for a particular instructor/teacher
from students.

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 Quantitative research: - Quantitative study is a formal, objective, systematic process in
which numerical data are used to obtain information. E.g. To analyse the intensity of the
pain one can use the following scale, which provides data in numeric form.

Research design

Quantitative Researches are structured means they require a study or research design.
Research design refers to the approach taken to answer a research question. A Research design
is a specific plan or protocol for conducting the study, which allows the investigator to translate
the conceptual hypothesis into an operational one.

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Features of good design
 Minimizes bias – reduces the possibilities of partial results.
 Maximizes the reliability of the data collected – increases the Genuineness of the results
obtained.
 The design which gives the smallest experimental error - providing maximum accuracy
with least uncertainty.
 Yields maximal information - provides highest knowledge of all the aspects of that
particular study, like population chosen, treatment aspects, methodology, etc.

Classification of research designs


Research designs are classified into two.
 Observational studies
 Experimental studies

Observational study design: - Observational research is a study where researchers simply collect
data based on what is seen and infer based on data collected. Studies that do not involve any
intervention or experiment E.g. As mentioned in the earlier example, collecting data on how the
students rate their teacher on his/her performance. Another example is assessing the Lumbar
Lordosis and Lumbar Core Strength in Information Technology Professionals. In these type of
studies a researcher does not introduce any intervention and he/she just collects the data.

Experimental study design: - Experimental research is a study in which a treatment, procedure,


or program is intentionally introduced and a result or outcome is observed. E.g. After
discharging from hospital, OPD based physiotherapy treatment / rehabilitation is a routine
procedure for a total knee replacement patient. If we want to assess the effectiveness of a
home based rehabilitation program instead of OPD based treatment then the patients can be
divided into two groups, one group consisting of patients treated in Hospital OPD (Control
group) and patients treated at their home (Experimental group). Subjects in both groups are

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assessed before the commencement of study (baseline) and either at the end of study or during
the course of study to assess the differences in outcome, if there any.

Classification of observational studies

1. Descriptive studies:
 Case reports (Case study)
 Case series
2. Analytical studies
 Cross sectional survey
 Case control
 Cohort

Descriptive research includes surveys and fact-finding enquiries of different kinds.


 Case study is a report or a description of some or all aspects of a patient. Usually this
report will describe an uncommon clinical presentation. E.g. describe in detail about a
clinical presentation & management of a rare disease.

E.g.
 Case report: Physiotherapy strategies for a woman with symphysis pubis
diastasis occurring during labour.
 Case report: the effect of physiotherapy and orthotic intervention, 40 years after
stroke
 Robot assisted physiotherapy to support rehabilitation of facial paralysis

 Case-series is basically an extension of the case-study. It consists of a report or a


description of some or all aspects of several patients with same diagnosis. The role of
the case-series is also similar to that of a case study but the meaning or implication
arising from a case series is greater due to the greater number of patients that are

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included. E.g. studying a clinical presentation of several patients with same diagnosis
and making a report describing all the cases.

Physiotherapy Management of People Diagnosed with de Quervain's Disease: A Case Series

In analytical study, the researcher has to use facts or information already available, and analyze
these to make a critical evaluation of the material. E.g. tobacco chewing causes oral cancer-
information already available. How many patients who chew tobacco have suffered from oral
cancer is analyzed.

 Cross sectional study is a onetime study of all persons in a representative sample of a


specific population. E.g. A cross sectional study can be used to look at the association
between obesity and television watching. A sample of people from population that we
are interested in can be polled and asked about their height/ weight ratio and the
number of hours of television that person watches each week. This study will give
insight as to whether obesity and television watching are associated, but it will not help
to determine which might cause the other. In other words, it is not known if obesity
causes more television watching or if more television watching causes obesity.
We can also find the Physical fitness in Type II Diabetes Mellitus patients.

 Cohort study is a prospective (expected or likely to happen in future) research design


that is used to evaluate the relationship between a potential exposure (e.g. Risk factor)
and an outcome (e.g. Disease).

E.g. If we want to assess the Risk factors for back pain in marines, a prospective cohort
study would be an ideal choice. We will enroll the eligible marines and assess their
baseline characteristics and follow up them for a defined period of time and reassess
them at the end of study about the occurrence of back pain.

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Exposure Occupational hazards
Outcome Back pain
Population All eligible marines

Case-control study is a retrospective (looking back on/ dealing with past events)
research design used to evaluate the relationship between a potential exposure (e.g.
Risk factor) and an outcome (e.g. Disease). Two groups of subjects- one of which has the
outcome (the case) and one which does not (the control) are compared to determine
which group has a greater proportion of individuals with the exposure. E.g. Association
between smoking and lung cancer

Risk factor Smoking


Outcome Lung cancer
Case People with lung cancer
Control People without lung cancer.

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Here the question investigated is the relationship between smoking and lung cancer.
Lung cancer takes years to develop so it was impractical to wait and see what happens
once someone started smoking. Instead researchers identified subjects diagnosed with
lung cancer and subjects free from disease and worked retrospectively to determine
each individual’s exposure to smoking. Results from the study provided enough
convincing evidence to conclude that smoking was a causal factor in causing cancer.

Another example is to find the association between Vitamin D deficiency and Chronic low back
pain
Risk factor Vitamin D deficiency
Outcome Chronic low back pain
Case People with low back pain
Control People without low back pain

Classification of experimental studies


In an experimental study, the participating subjects are grouped into two or more groups and
one group receives the gold standard treatment (control) and other group receives the
experimental treatment (experimental). It can be
 Non randomized control trial or
 Randomized control trial (RCT)

In a Non RCT, the researcher decides / controls on allocation of group to a participating subject
whereas in a RCT the researcher does not have any such control.

Randomised controlled trial (RCT)


Random means unexpected or not planned and in Randomization each person has equal
chance to get selected in any of the groups that is planned.

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 Randomised controlled trial is a type of Study design where treatments, interventions,
or enrolment into different study groups are assigned by randomization.
Randomization can be done very simply by tossing a coin, by computer generated
random number or by using a random table. Randomization can also be done by lottery
method.

The randomised controlled trial is the most appropriate research design to evaluate the
effectiveness of an intervention. A study in which 1) There are two groups, one
treatment group and one control group. The treatment group receives the treatment
under investigation, and the control group receives either no treatment or standard
treatment. 2) Patients are randomly assigned to either one of the groups.

In the previous example of total knee replacement, the patients are grouped in to two. One
group t receive hospital OPD based physiotherapy treatment / rehabilitation (control) and other
group to receive home based rehabilitation program (experimental). In a RCT, the researcher
does not have any control over subjects’ allotment to any one of the group.

33
Advantages of RCT

“gold standard” of research designs.

Best evidence study design

Controlling for possible factors that may affect outcomes (confounders)

Both groups are Comparable at the beginning (using randomization)

Disadvantages

Long term follow-up (possible losses)

Compliance

Expensive

34
Large trials (may affect statistical power)

Though RCT is considered as gold standard, no other design is considered as less effective and
the Choice of research designs depends on:
 Research Questions
 Research Goals
 Time and cost constraints

Exercises:
Give one example of research.

Give one example of research in physiotherapy.

Identify the research design

• To study is there a difference between personal education and video education to


patient with breast cancer in her physical, emotional and social adjustments

• To study whether home based nursing intervention for infant irritability reduces the
parenting stress or not

• To study whether any relationship between pain and functional disability in older
patients

Discuss the difference between qualitative and quantitative research and give example for
each.

Discuss the difference between cohort and case control study and give example for each.

35
Chapter – 6 LEVELS OF EVIDENCE

A number of research designs are given in previous chapter. One should anticipate the
differences of each research design when planning their search strategies in order to increase
the efficiency of the process. The selection process may be eased somewhat by ranking
research designs based on their ability to minimize bias. Proponents of evidence based
medicine have attempted to make the study selection process easier by developing hierarchies
or level of evidence. In 2006, Melynk, B.M. designed pyramid of level of evidence.

Rating System for the Hierarchy of Evidence (Melnyk, 2006)

• Level VII. Evidence from opinion of authorities and/or reports of expert committees.
• Level VI. Evidence from a single descriptive or qualitative study.
• Level V. Evidence from descriptive and qualitative studies.
• Level IV. Evidence from well-designed case-control and cohort studies.
• Level III. Evidence obtained from well-designed controlled trials without randomization
(quasi-experimental).

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• Level II. Evidence obtained from at least one well-designed RCT.
• Level I. Evidence obtained from a systematic review or meta-analysis of all relevant,
randomized clinical trials (RCTs), or clinical practice guidelines based on systematic
reviews of RCTs.
Here expert opinion is the lowest level of evidence (level VII). Professional who has acquired
knowledge and skills through study and practice over the years, in a particular field or subject,
to the extent that his or her opinion may be helpful in fact finding, problem solving, or
understanding of a situation.
Different types of research designs included from level VI to level II are described in previous
chapter where level II describes randomized controlled trial which is considered to be the “gold
standard” in research. Beyond that, there is one higher level of evidence (level I) i.e. systematic
review and Meta-analysis.

Systematic Reviews
Systematic review is a summary of the medical literature that uses precise methods to
systematically search, critically appraise and synthesize the literature on a specific issue. A
systematic review is a comprehensive survey of a topic.
Systematic review takes great care to find all relevant studies of the highest level of evidence,
Published and unpublished. It assesses each study, in explicit and reproducible way and
presented in a balanced and impartial summary of the findings. E.g. collect all the RCTs done on
different exercises in osteoarthritis. Select the best matching studies, based on our research
question. Critically appraise those articles and synthesize all studies to see effectiveness of
different exercises used for osteoarthritis.

Meta-Analyses
Meta-analysis is a systematic, objective way to combine data from studies in a systematic
review. The advantage to merging these data is that it increases sample size and allows for
analyses that would not otherwise be possible.

37
The difference between a systematic review and a meta-analysis is that a systematic review
looks at the whole picture (qualitative view), while a meta-analysis looks for the specific
statistical picture (quantitative view). E.g. 10 studies are included in systematic review on effect
of exercises in OA knee. Each study consist 100 patients. So you take all 1000 patients’ data and
analyze them statistically and find the result on effectiveness of exercises in OA knee.

Exercise:
1. Give one example of situation where you asked for expert opinion in your life.

38
Chapter – 7 STATISTICS

Open a newspaper and start looking for examples of articles and stories involving numbers. It
doesn't take long before numbers begin to pile up. Readers are inundated with results of
studies, announcements of breakthroughs, statistical reports, forecasts, projections, charts,
graphs, and summaries. The extent to which statistics occur in the media is mind-boggling. In
today's numbers explosion, the buzzword is data, as in, "Do you have any data to support your
claim?" "What data do you have on this?" "The data supported the original hypothesis that …",
"Statistical data show that …", and "The data bear this out ….". But the field of statistics is not
just about data. Statistics is the entire process involved in gathering evidence to answer
questions about the world, in cases where that evidence happens to be numerical data.

Statistics is concerned with the scientific method by which information is collected, organised,
analysed and interpreted for the purpose of description and decision making.

Biostatistics is the application in Statistics to a wide Range of topics in biology. (wikipedia).


Biostatistics covers applications and contributions not only from the field of health, medicine
and nutrition but also from fields such as agriculture, genetics, biology, biochemistry,
demography, epidemiology, anthropology and many others. Biostatistics is the art of making
numerical conjectures about puzzling questions. e.g. What are the effects of new medical
treatments ?

There are two subdivisions of statistical method.


(a) Descriptive Statistics - It deals with the presentation of numerical facts, or data, in either
tables or graphs form, and with the methodology of analysing the data.
(b) Inferential Statistics - It involves techniques for making inferences about the whole
population on the basis of observations obtained from samples.

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Descriptive statistics are used to describe the basic features of the data in a study. Descriptive
Statistics are used to present quantitative descriptions in a manageable form. In a research
study we may have lots of measures. Or we may measure a large number of people on any
measure. Descriptive statistics help us to simplify large amounts of data in a sensible way. Each
descriptive statistic reduces lots of data into a simpler summary. Together with tables and
simple graphics analysis, they form the basis of virtually every quantitative analysis of data.

What is data?
Data can be defined as a collection of facts or information from which conclusions may be
drawn.
Eg. Height and weight of every individual in a class.

Types of data A variate or random variable is a quantity or attribute whose value may vary from
one unit of investigation to another. For example, the units might be headache sufferers and
the variate might be the time between taking an aspirin and the headache ceasing. An
observation or response is the value taken by a variate for some given unit. There are various
types of variate.

Qualitative data / Categorical data


Quantitative data

Qualitative data is a categorical measurement expressed not in terms of numbers, but rather by
means of a natural language description.

Qualitative data can be of Nominal and ordinal data.


A nominal data is a data where there is no natural ordering
Eg. Gender, Race, Blood group (A, B, AB, and O), Marital status (married/widowed/single etc.)

An Ordinal data is a data where the categories may be ordered.

40
Eg. Sizes (small, medium and large), levels of agreement (agree, somewhat agree, disagree) etc

Quantitative data is where numerals are involved.

Discrete data – no fractions are possible in numbers


Eg. Live births, no of times hospitalized etc
Continuous data – fractions are possible
Eg. Height of an individual, weight etc

Descriptive statistics are used to describe the basic features of the data in a study. It is just a
description of what data shows.
Displaying data
It is nearly always useful to use graphical methods to illustrate data.
Discrete data: frequency table and bar chart
Continuous data: histograms

Normally distributed data


The histogram is bell-shaped, like the probability density function of a Normal distribution. It
appears, therefore, that the data can be modelled by a Normal distribution (Bell curve).
Normal distribution is a summary of the frequency of individual values or ranges of values for a
variable. In a Normal Curve the central tendency is an estimate of the center of a distribution of
values.

41
Measures of location
By a measure of location we mean a value which typifies the numerical level of a set of
observations. (It is sometimes called a "central value", though this can be a misleading name.)
We shall look at three measures of location and then discuss their relative merits

Mean
Mean is the average value of a set of numbers. The mean is calculated by adding up all the
values, and then diving that sum by the number of values. E.g. The test score of seven students
are 98, 96, 96, 84, 80, 80, 72. So, the mean score of all seven students is 87.
[(98+96+96+84+80+80+72)/7 = 609/ 7=87]

Median
The median is the middle value in a set of values. To find the median, order the numbers from
largest to smallest or vice versa, and then choose the value in the middle. E.g. 1, 4, 3, 6, 2, 7, 5.
First arrange them in order, i.e. 7, 6, 5, 4, 3, 2, 1 and select the middle value i.e. 4. So the
median is 4.
If you have even number of observation, then median is calculated as follow. E.g. 1, 2, 3, 4, 5, 6.
Both 3 and 4 are in middle. Take average of those values, (3+4)/3=3.5 is the median.

42
Mode
The mode of a observation is the value or values that occur most frequently. There can be more
than one mode of a set. E.g. 10, 10, 4, 12, 10, 13, 12, 14. Here, 10 is the frequently occurring
observation so, 10 is the mode.
Let’s take another Example, 10,10,3,6,8,10,8,8. Here 8 and 10 both are occurring three times so
both are modes.

The dispersion
It refers to the spread of the values around central tendency.
Range
It is the variation between upper and lower limits of a scale. E.g. the score of a class test of all
students vary from 60 to 90 marks. Range is highest value minus lowest value. E.g. 15, 28, 31,
35, 27, 36. Here, highest value is 36 and lowest value is 15 so range is 36-15=21
Standard deviation (SD)
The standard deviation is the average distance between each data point and the mean. SD gives
a more complete picture of the distribution of elements in a data set. A low standard deviation
means that most of the numbers are very close to the average. A high standard deviation
means that the numbers are spread out. SD is calculated with following formula:

Where X represents each value in the population, M is the mean value of the population, Σ is
the summation (or total), and n is the number of values in the population.
For example values are 6,2,5,3. Mean is 4. The first data point is 6 and the mean is 4, so the
distance between them is 2. Squaring this distance gives us 4.
X=6, M=4, n=4, SD= 1
Exercises:
1. Find out the mean, median, mode, range and standard deviation for following data
20, 25, 21, 20, 23, 22, 24.

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Chapter – 8 THE COCHRANE COLLABORATION

Cochrane collaboration is a global independent network of researchers, professionals, patients,


carers, and people interested in health. There are more than 37,000 Cochrane contributors
from more than 130 countries, they work together to produce credible, accessible health
information that is free from commercial sponsorship and other conflicts of interest.

The Cochrane reviews database contains systematic reviews and Meta-analyses. Their work is
recognized as representing an international gold standard for high quality, trusted information.
The mission of Cochrane collaboration is to provide accessible, credible information to support
informed decision-making has never been more important or useful for improving global
health.

44
Chapter – 9 OUTCOME MEASURES

What is an outcome measure?


An outcome is either a measurement or an event that is potentially modifiable by a defined
intervention. E.g. Change in Range of motion of a given joint after exercise, measured by
goniometer. Here outcome is ROM (modifiable, measurable), measured using goniometer.
Outcome measures can be used
 To detect change over time (e.g. treatment effects),
 To discriminate among clinical groups (e.g. to observe the population of smokers
who develop lung cancer and who are not) or
 To predict future outcomes (e.g., return to work).
Need For Outcome measures
 Individual patient progression (improvement in ROM after exercise)
 Evaluation & planning of patient programs (selecting appropriate treatment
according to findings)
 Quality management (efficacy in performing daily activities)
 Research (collection of data)
Outcome measures are divided according to the components of rehabilitation:
 Body structure and function (ROM of elbow joint)
 Activity (eating with that limb)
 Participation(driving)
 Health related quality of life

Features of outcome measures


In order for outcome measures to be used appropriately and effectively, it is important that it is
easy to use in terms of administration and time; equally they should not cause pain or
discomfort to the patient being assessed.

45
A key feature of an outcome measure is that it should demonstrate both validity and reliability
and be sensitive to the change(s) required to be measured as the change(s) occur(s) over time.

Reliability
The reliability of an outcome measure is concerned with how effectively the assessment can be
repeated when it is employed by different individuals and on different occasions.
E.g. ROM of elbow joint is measured with goniometer by two different therapists or measured
by same therapist at different time gives same result.
 Test retest reliability: It may be established when an instrument is used on two separate
occasion with the same subject.
E.g. ROM of elbow joint is measured with goniometer by same therapist at different
time gives same result.
 Instrument reliability: Internal consistency: is a form of reliability that is relevant to self-
report instruments, such as health related quality of life questionnaires. These surveys
usually have several items or questions, groups of which are designed to measure
different concept or constructs within the instrument.
 Instrument reliability: parallel forms: This can be established only in cases where two
versions of instrument exist, both of which measure the same constructs or concepts.
E.g. Will Tape measure A give the same height measurement as tape measure B?
 Instrument reliability: split half: It eliminates the need for two test administrations by
combining the two forms of an instrument into one longer version. Subjects complete
the entire instrument and then investigators separate the items for comparison to
determine the degree to which scores agree for the same items or concepts. E.g. A test
is split into two, odds and evens, if the two scores for the two tests are similar then the
test is reliable.
 Intra rater reliability: The consistency of repeated measure performed by one individual
is referred as intra rater reliability. E.g. Therapist measuring ROM should be able to
obtain nearly the same score for the same position each time the measure is taken.

46
 Inter rater reliability: The consistency of repeated measure performed by several
individuals is referred as inter rater reliability. E.g. several therapists from same clinic
measuring ROM of same patient give consistent score.

Validity
The validity of an outcome measure is the ability of measure what is intended to measure. E.g.
A goniometer measures joint position in degrees is valid instrument for ROM whereas
thermometer is not.
 Face validity: is tested with the question, “Does this instrument appear to be the
appropriate choice to measure this variable?” this is a “yes-no” question. E.g. is
goniometer appropriate to measure ROM?
 Content validity: an instrument is said to have content validity when it represents all the
relevant facets of the variable it is intended to measure. E.g. A questionnaire to know
the effect of disease or disorder on lower extremity function should contain item that
address the performance of the entire leg (not about the upper extremity function).
 Construct validity: construct validity defines how well a test or experiment measures the
construct. It refers to whether the operational definition of a variable actually reflects
the true theoretical meaning of a concept. E.g. Doctor testing the effectiveness of
painkillers on back pain. The subject is asked to rate the pain level out of ten. In this
case, construct validity would test whether the doctor actually was measuring pain and
not numbness, discomfort or anxiety.
 Criterion validity: the criterion validity of an instrument reflects the degree to which its
scores are related to score obtained with a reference standard instrument. E.g.
comparison between the results of a clinical examination technique and MRI to detect
soft tissue damage. The MRI is the superior test because of its ability to capture images
of the affected tissue. The clinical examination technique will have high criterion validity
if it produces the same results as the MRI.

47
Sensitivity
The sensitivity of an outcome measure is its ability to detect subtle changes in a patient’s
progress when measured over a specific period of time. E.g. Goniometer is able to measure the
smallest change that occurs in a range.

Benefits of Outcome Measure


 To demonstrate accountability.
 To improve clinical and management decision, making for optimal care delivery.
 For research and incentives.
Examples of different outcome measures
 Visual Analogue Scale (VAS) - for assessing intensity pain
 Short form-36 (SF - 36) for assessing health status
 Western Ontario and Mac Master Universities Osteoarthritis Index (WOMAC) for
assessing disability caused by Osteoarthritis

Exercises:
1. Give two examples of outcome measure used in physiotherapy.
2. Explain reliability and validity using one example of outcome measure.
3. Discuss the difference between intra-rater and inter-rater reliability.

48
References:
 Herbert & Jamtvedt: Practical Evidence Based Physiotherapy, 2nd Edition.
 Stillwell, Susan B. et al, evidence based practice, step by step: searching for the
evidence, Americal Journal of Nursing, May 2010, vol.110.
 Dianne V. Jewell: Guide to Evidence-Based Physical Therapy Practice.
 K. Park & Park: park’s textbook of preventive and social medicine: 23rd edition.
 C. R. Kothari: Research Methodology, second revised edition.
 Glover, Jan; Izzo, David; Odato, Karen & Lei Wang. EBM pyramid. Dartmouth
University/Yale University. 2006.
 Dianne V. Jewell: Guide to Evidence-Based Physical Therapy Practice.
 www.cochrane.org.
 National Council for Osteopathic Research 2012.
 Steven Sadowsky, Ellen Hillegas, essentials of cardiopulmonary physical therapy.
 Priscilla Velentgas, et al, Developing an Observational CER protocol: A user’s guide,
chapter 6: outcome definition and measurement.

http://cosmologist.info/teaching/STAT/CHAP4.pdf
Grinnell, Richard Jr (eds), 1993, Social Work Research and Evaluation (4th edn), Itasca,
IL, F.E. Peacock.

49
Chapter – 10 CRITICAL APPRAISAL

What is Critical appraisal?

Critical appraisal is the process of carefully and systematically examining research to judge its
trustworthiness, and its value and relevance in a particular context.E.g., An Article suggesting
Physiotherapyto be beneficial in one of the Musculoskeletal Condition is critically appraised to
check its trustworthiness and its value for that particular condition.

Purpose of critical appraisal:

• Does this study address a clearly focused question?


• Did the study use valid methods to address this question?
• Are the results of this study valid &important?
• Are these valid, important results applicable to patient or population?
When reading any research, it is important to remember that there are three broad things to
consider: validity, results, relevance.

It is always necessary to consider the following questions.

• Does the study address an appropriate and clearly focused question?


• Are the selection criteria are clearly described?

• Does it give a clear description of the methodology used?


• Has the research been conducted in such a way as to minimise bias?
• If so, what does the study show?
• What do the results mean for the particular patient or context in which a decision is being
made?
• Is there Summarization of the author’sconclusions?

Advantages of Critical appraisal

 Contributes to improving practice (quality)


 Encourages objective assessment of information

50
 Not difficult to develop skills

Disadvantages of Critical appraisal

 Not always any easy answers or what you hoped to find

Critical appraisal of different design

1. Critical analysis of a Case Study

Fig: Area highlighted shows Title of Article and the Abstract

51
Fig: Area highlighted shows Purpose of the study

Fig: Area highlighted shows Authors Conclusion in the Article

52
Critical analysis of a Case Series

Fig: Area highlighted shows Title of the Article along with the Abstract

53
Fig: Area highlighted shows Purpose of the study

54
Fig: Area highlighted shows Inclusion and Exclusion Criteria

Fig: Area highlighted shows Method of Data Collection

55
Fig: Area highlighted shows Outcome of the study

56
Fig: Area highlighted shows Authors Conclusion in the Article

57
3. Critical appraisal of Cross Sectional Study:

Fig: Shows Title of the Article along with the Abstract

58
Fig: Area highlighted shows Purpose of the study

Fig: Area highlighted shows Study Design along with Inclusion and few of the Exclusion Criteria

59
Fig: Area highlighted shows Method of Data Collection

60
Fig: Area highlighted shows Outcome Measures

61
Fig: Area highlighted shows Statistical Analysis in the Article

62
Fig: Area highlighted shows Authors Conclusion in the Article

63
4. Critical Analysis of Case Control Study

Fig: Area highlighted shows Title of the Article along with the Abstract

64
Fig: Area highlighted shows Purpose of the study

65
Fig: Area highlighted shows Inclusion Criteria

66
Fig: Area highlighted shows Study Design and Method of Data Collection

67
Fig: Area highlighted shows Statistical Analysis in the Article

Fig: Area highlighted shows Authors Conclusion in the Article

68
5. Critical Appraisal of Retrospective Cohort study

Fig: Shows Title of the Article along with the Abstract

69
Fig: Area highlighted shows Purpose of the study

Fig: Area highlighted shows Study Design

70
Fig: Area highlighted shows Inclusion and Exclusion Criteria

Fig: Area highlighted shows Method of Data Collection

71
Fig: Area highlighted shows Statistical Analysis in the Article

Fig: Area highlighted shows Authors Conclusion in the Article

72
6. Critical appraisal of Randomized Controlled Trial

73
Fig shows Title of the Article along with general Details and Abstract

Fig: Area highlighted shows Purpose of the study

Fig: Area highlighted shows Inclusion, Exclusion Criteria

74
Fig: Area highlighted shows study design

Fig: Area highlighted shows Outcome Measures

75
Fig: Area highlighted shows Statistical Analysis

Fig: Area highlighted shows Conclusion by the Author

76
Scoring system

Sr. no Criteria 10 points 5 points 0 points


1. Purpose of the Defined Inadequately Not defined
study defined

2. Design Good Fair Poorly designed or


wrong
3. Subjects /sample Defined Inadequately Not defined
inclusion / exclusion defined
criteria

4. Method data Correct Doubtful wrong Wrong


collection

5. Outcome measure Clearly defined Incompletely Poorly defined


defined

6. Statistical analysis Complete adequate Incomplete Wrong or missing


methods

7. Authors conclusion Adequate based on Doubtful Irrelevant / wrong


results

8. Clinical impact 30points for high 15 points for 0 for unimportant


Impact moderate

Interpretation of Bigby and Gadden scoring system

Maximum score is 100

Quality Scoring
Good / very good ≥80 and <100
Fair 55-79
Not acceptable <55
If the Score is below 55 than the article is of not much importance and validity
(5 different studies of different types should be added for appraisal)

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Chapter – 11 COMMUNICATINGEVIDENCE TO CLIENTS, MANAGERS AND
FUNDERS

Effectively communicating evidence

An effective communication regarding evidence is one in which a message has not only been
sent but also received, understood, and act upon- known as knowledge utilization,making
communication bridge between client and therapist.For example the ergonomic advice given by
therapist to an Osteoarthritis knee patient to avoid cross leg sitting, squatting and stair climbing
as being received, understood, and acted upon by the patient in proper sense.

The path of effective evidence based communication

1. Identify the clinical role of decision maker with respect to therapist


• Three types of the decision makers with whom therapist are likely to communicate.
• Client or family member
• Manager and
• Funder
• The clinical role of clients and family members is to receive therapy services to improve
their lives. Communication with clients and family members often occurs face to face in
periodic and repeated appointment.
• The clinical role of manager is to develop therapy programs, allocate resources such as
space, budget, materials, staff support and guide therapist’s provision of
service.Communication with managers often occurs face to face.
• The clinical role of funders is to decide whether to fund the development of future
clinical programs and provision of current clinical service from an array of possible
services and program.

2. Identify the decisions that decision maker will be involved in making with the therapist
3. Gather and interpret research evidence that is guided by the information needs of decision
maker and the clinical population of interest

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4. Translate the evidence into a comprehensible communication to facilitate an informed
discussion with the decision maker.

Decision maker Decision makers use of Questions that guide search for
evidence evidence
Client (OA Knee Patient for To make informed decisions What is the most effective and
Participating in Program) about participating in feasible physical therapy
and Family Members intervention procedures intervention for achieving
(Regarding benefits of the participation in successful and safe
Patient participating in the Aerobic Exercise program among
program) 40 to 70 years old men and
women with Osteoarthritis knee?
Manager To decided which intervention What is the most effective and
procedures would be feasible physical therapy
supported and provided by intervention for achieving
the organization personally meaningful goals
among person with Osteoarthritis
knee?
Funder To decide whether or not the Same Question as for Manager
predicted level of
Effectiveness and feasibility of
a clinical intervention program
is worth funding

Exercise:

 How you would communicate evidences to the Patient, Family Members and the
Managers in five different Conditions.

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Chapter – 12 INFERENTIAL STATISTICS

P values and statistical significance

A “P value” is the probability of obtaining the observed effect (or larger) under a ‘null
hypothesis’, which in the context of Cochrane reviews is either an assumption of ‘no effect of
the intervention’ or ‘no differences in the effect of intervention between studies’ (no
heterogeneity).

P-values in scientific studies are used to determine whether a null hypothesis formulated
before the performance of the study is to be accepted or rejected. In exploratory studies, p-
values enable the recognition of any statistically noteworthy findings.

‘2Thus, a P value that is very small indicates that the observed effect is very unlikely to have
arisen purely by chance, and therefore provides evidence against the null hypothesis.

It has been common practice to interpret a P value by examining whether it is smaller than
particular threshold values. In particular, P values less than 0.05 are often reported as
“statistically significant”, and interpreted as being small enough to justify rejection of the null
hypothesis. (EGS to be added)

Confidence Interval

The confidence interval is a range of values calculated by statistical methods which includes the
desired true parameter (for example, the arithmetic mean, the difference between two means,
the odds ratio etc.) with a probability defined in advance (coverage probability, confidence
probability, or confidence level).

The confidence level of 95% is usually selected. This means that the confidence interval covers
the true value in 95 of 100 studies performed. The advantage of confidence limits in
comparison with p-values is that they reflect the results at the level of data measurement.

(EGS to be added), Normal distribution curve to be added

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Relative Risk (RR)

Relative risk measures the magnitude of an association between an exposed and non-exposed
group. It describes the likelihood of developing disease in an exposed group compared to a
non-exposed group.

Relative risk is calculated using cumulative incidence data to measure the probability of
developing disease. Therefore, relative risk can only be calculated if the study was designed in
such a way that incidence data can be calculated. For example, study designs such as cohort
studies and clinical trials allow the researcher to calculate incidence, whereas case-control
studies do not. Thus, relative risk can be calculated for cohort studies and clinical trials, but not
for case-control studies.Odds ratios can be used to estimate relative risk for a case-control
study.

Relative risk is:(Cumulative incidence in the exposed)


(Cumulative incidence in the unexposed)

Calculating Relative Risk

Relative risk can be calculated from a 2x2 table using the following formula:

Relative Risk = (A / (A+B))


(C / (C+D))

Disease - Yes Disease - No Total


Exposure - Yes A B A+B
Exposure - No C D C+D
Total A+C B+D A+B+C+D

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For Example:

Cases (with Lung Controls (without Total


Cancer) Lung Cancer)
Smokers 33 55 88
(<5 Cigarettes per day) a b (a+b)
Non Smokers 2 27 29
c d (c+d)
Total 35 82
117=N
(a+c) (b+d)

Relative Risk = (A / (A+B))=33/88 =0.375/0.069 =5.44


(C / (C+D)) 2/29

Odds Ratio (OR)

An odds ratio (OR) is a measure of association between an exposure and an outcome. The OR
represents the odds that an outcome will occur given a particular exposure, compared to the
odds of the outcome occurring in the absence of that exposure. Odds ratios are most
commonly used in case-control studies.

Odds ratios are used to compare the relative odds of the occurrence of the outcome of interest
(e.g. disease or disorder), given exposure to the variable of interest (e.g. health characteristic,
aspect of medical history). The odds ratio can also be used to determine whether a particular
exposure is a risk factor for a particular outcome, and to compare the magnitude of various risk
factors for that outcome.

 OR=1 Exposure does not affect odds of outcome


 OR>1 Exposure associated with higher odds of outcome
 OR<1 Exposure associated with lower odds of outcome

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We will Calculate ODDs Ratio (OR) using a 2x2 frequency table

Outcome Status
+ -
+ a b
Exposure status
- c d

For Example:

Cases (with Lung Controls (without Total


Cancer) Lung Cancer)
Smokers 33 55 88
(<5 Cigarettes per day) a b (a+b)
Non Smokers 2 27 29
c d (c+d)
Total 35 82
117=N
(a+c) (b+d)

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Odd Ratio=ad/bc= 33 × 27/55 × 2=8.1

i.e. Cigarette Smokers have 8.1 times of developing Lung Cancer compared to Non Cigarette
Smokers

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Chapter – 13 ECONOMIC EVALUATION

What is economic evaluation?

Economic evaluation is defined as “the systematic appraisal of costs and benefits of projects,
normally undertaken to determine the relative economic efficiency of programs.”

By definition, economics is the study of decisions, through the examination of program


incentives and consequences, and the measure of service production, delivery, and
consumption. For e.g. Low back pain is one of the most frequently encountered conditions in
clinical practice. Up to 84 percent of adults have low back pain at some time in their lives, and
over one quarter of U.S. adults report recent (in the last 3 months) low back pain. Low back
pain can have major adverse impacts on quality of life and function.Low back pain is also costly:
total U.S. health care expenditures for low back pain in 1998 were estimated at $90 billion.In
addition to high direct costs, low back pain is one of the most common reasons for missed work
or reduced productivity while at work, resulting in high indirect costs.Simply put, economic
evaluation is the understanding and use of economic evidence in decision making.

Economic evaluation contributes to evidence-based decision making in public health by helping


leaders and the community identify, measure, and compare activities with the necessary
impact, scalability, and sustainability to optimize population health. For example, Economic
evaluation would help country like India to decide how much monetary fund to be spent for
Health Sector. In the words of Dr. Thomas Frieden, the Director of the U.S. centres for Disease
Control and Prevention, “to establish an effective intervention package, it is critical to
understand the full range of available evidence-based strategies, the size and characteristics of
the population to be reached, the projected impact of each intervention, and the estimated
cost”. For example, the Government of India has to decide whether Prevention or Curing of
patients with Malaria would be more beneficial and effective than treating patients affected
with Malaria. It is also obvious that Finance to be spent for Prevention is much lesser than
curing the disease.

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Types of Economic Evaluation and Decision Levels

There are two levels of economic evaluation: partial and full. Partial economic evaluation
measures program or disease costs, but does not involve a comparison with alternative options
and does not relate costs to outcomes. Partial economic evaluations include cost-of-illness
analysis and program cost analysis. For example the estimate of cost by the Health care
ministry for the treatment of Polio disease. In public health, full economic evaluation compares
two or more public health interventions through the examination of costs of inputs and
outcomes. Full economic evaluations include cost-benefit, cost-effectiveness, and cost-utility
analyses. For Example for the treatment of Low Back Pain, Conservative treatment in form of
Ergonomic Advices, Pharmacological Drugs and Physical Therapy is beneficial compared
toSpinal Surgery and would increase the functional performance of Patients and along with
work output.

Steps in Conducting Economic Evaluation

To carry out Economic Evaluation, the researchers should have definite problem and objectives
for research, need to identify the alternatives and describe each alternative, identifying
whether financial or economic data will be collected, collecting background data (on salaries,
inflation, discount rates) from the Ministry of Health, the Ministry of Finance or other Central
Economic Planning and Statistical Offices; identifying the different types of cost data that are
needed, and collecting these data from the program or project. Ideally, the ultimate indicator of
public health impact would reflect the impact on morbidity and mortality as a result of the
intervention. Ultimately the statistical Analysis would be carried out and finally the Economic
Evaluation is used in Decision Making post Critical Analysis.

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