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How to develop a
Research Protocol ?
Dr. Farzana Saleh Ph.D.
Associate Professor of CN
Bangladesh University of Health
Sciences
Differences between Research
Protocol and Research Proposal
 A research protocol is a detailed set
of activities for the proposed project
and these activities are supported
by evidence from
other research and from the
preliminary investigations.
 A research proposal is a concise
and clear summary of the proposed
research. SYNOPSIS.
What is Research?
 A methodical investigation, involving
the collection of information (data),
to solve a problem or contribute to
knowledge about a theory or
practice.
 Research is critical in medicine
because it leads to new discoveries
and can change peoples’ lives by
improving health and well being.
What is Research?
 Research helps to provide scientific
understanding and solves practical
problems.
 Relies on methods and principles
that will produce reliable and
supportable results.
 All research starts with an idea or
question based on personal
experiences.
Research (cont.)
 careful or attentive search
 studious inquiry or examination
 especially : investigation or
experimentation aimed at the discovery
and interpretation of facts, revision of
accepted theories or laws in the light of
new facts, or practical application of
such new or revised theories or laws
 the collecting of information about a
particular subject
Scientific Approach
 The most sophisticated method of
acquiring knowledge is - scientific
approach.
Combines important features of
induction and deduction together with
other methods to create a system of
acquiring knowledge.
 Generally more reliable than other
methods.
 Approach used most often to perform
medical or public health research.
Scientific research
is an integrated approach of deduction
and induction
Deduction
Hypothesis generation
Testing the hypothesis
Induction
(Inference on hypothesis)
generalization of the results
In sample
population
Universe
known truths
Causal model of risk factors for CVDCausal model of risk factors for CVD
Morbidity and Mortality
(Stroke, MI)
Biological Risk Factors
(Hypertension, Blood Lipids, Homocysteine)
Genetic Risk Factors
(Family History)
Behavioral Risk Factors
(Cigarette, Diet, Exercise)
Environmental Factors
(Socioeconomic Status, Work Environment)
Protocol writing
 What is your question ?
 Why is your study important ?
 How are you going to do it ?39
Key Points of Your Proposal
Choosing a topic
 Should be interesting – to investigator,
funding agency, journal editors,
consumers (colleagues, public health
researcher)
 Relevance- add new information to the
scientific world
 Simple and manageable in scope
(feasibility in terms of money, time,
manpower)
 Expected results likely to alter clinical or
health policy decisions in future
The GOOD IDEA must be
 Feasible
 Do-able by you
 Do-able at your institution, hospital
& community
 Acceptable to your institution
 In conformity with human welfare
policies
 Conceptually significant
Steps in conduct of research
planning and execution
The first and foremost is
formulating a research question,
the most challenging part
Identify the Question
Sources for identifying the question
or problem:
Personal experiences
Literature review
Theories
Ideas from others
Identify the Question
Criteria for evaluating the
question:
Significance
Convenience
Feasibility
Interest to researcher
Research question
 IT SHOULD BE A SINGLE SENTENCE
IN THE FORM OF A QUESTION.
 IT SHOULD BE CLEAR DEFINITE AND
SPECIFIC.
What to have in a complete
study protocol ?
 Title
 Abstract
 Introduction
a)Rationale
b)Hypothesis/ Research question
 Literature Review
 Study Objectives
What to have in a complete
study protocol ?
 Methods and materials
a)Ethical consideration
 Time line/ Plan of work
 Reference
 Budget
Title must reflect the central
theme: selling point
Attractive and easy to understand
Concise and Informative: avoid
non-informative words like “ A
study of---”
Title
Bioavailability and Health Effects
of Isoflavones from Bangladeshi
Soybean and Lentils in
Postmenopausal Women
Example of a Title
1. Title of your Research Proposal
2. Name of the Supervisor (s)
3. Name of the Principal
Investigator (PI)
4. Name of the Co-investigators (if
you want or have)
5. Place of the Study
6. Duration of the Study
Contents of a Title Page
Thesis protocol should have
abstract section.
The abstract should-
a)Provide a brief overview of the
proposal that gives a reader a
basic understanding of the
proposal and encourages her or
him to read more.
Abstract
b) Summarize
− Introduction
− Statement of the Problem
− Research Questions or
Hypotheses
− Methods
− Expected Results
− Expected Conclusions
Abstract
Example of a Abstract
Introduction
 Study protocol should have
introduction/Background section.
 The introduction helps put your
project in conversation with other
projects on similar topics.
 Generally, the introduction provides
necessary background information to
your study and provides readers with
some sense of your overall research
interest.
Introduction
A good introduction should:
Establish the general ground (real
world or research) in which the
research is placed.
Describe the broad foundations of
your study, including some references
to existing literature and/or empirically
observable situations.
Introduction
 In other words, the introduction needs
to provide sufficient background for
readers to understand where your
study is coming from.
 Indicate the general scope of your
project, but do not go into so much
detail that later sections
(purpose/literature review) become
irrelevant.
Literature Review: In your review of literature
you are expected to do the following:
1. Place one's original work in the
context of existing literature.
2. Interpret the major issues surrounding
your topic.
3. Describe the relationship of each
work to the others under
consideration.
4. Identify new ways to interpret, and
shed light on any gaps in previous
research.
Literature Review: In your review of literature
you are expected to do the following:
5. Resolve conflicts among seemingly
contradictory previous studies.
6. Determine which literature makes a
significant contribution to the
understanding of your topic.
7. Point the way to further research on
your topic.
Literature Review: Contents
 The Literature Review
 must be well structured
 your ideas must flow logically from one
point to the next.
 Ensure sources and references are
current and relevant, cited appropriately
according to your discipline.
 Present terminology and viewpoints on
the topic in an balanced and
comprehensive manner.
Literature Review: Contents
Include the following content in your
Literature Review:
Provide an overview of the subject, issue, or
theory under consideration.
Divide outside works into categories and
concepts.
Connect the works to what has come
before your work and ideas.
Provide conclusions about those works that
make the greatest contribution to the
understanding and development of your
subject.
Literature Review: Considering the points
 Qualifications: What are the author's
credentials to make the judgments
he or she has made?
 Neutrality: Is the author's perspective
even-handed or biased?
 Credibility: Which of the author's
theses are convincing and why?
 Worth: Do the author's conclusions
add to the value of your own?
Literature Review: Considering the points
 Your transitions between ideas
analyze, synthesize, and assess
these outside perspectives, and do
not simply summarize or translate
them.
Literature Review: Way of the presentation
 Selecting and quoting only the most
relevant material for your subject and
argument.
 Making sense of the quotation within
the context of your argument.
 Introducing and integrating only
relevant quotations into your literature
review.
 Focusing on the language of
quotations in the interpretations.
 Every research work must have
research question (s)/hypothesis.
 A Research question is a statement
that identifies the phenomenon to
be studied
 Many studies have more than one
research question.
Hypothesis/ Research questions
 Research Question:
What is the quantity of total isoflavones in
locally available soybean (Glycine max)
and lentils [Mung bean (Vigna radiata) and
Masoor dahl (Lens culinaris)]?
 Hypothesis:
Isoflavones from Bangladeshi soyabean
and lentils have beneficial effects on
health among postmenopausal women
and it has an association with the levels of
follicular stimulating hormone (FSH).
Example: Hypothesis/
Research questions
 In this section you need to explain
why your research is important?
 Any novel ideas or contributions that
the proposed project offers should
also be discussed.
Rationale and significance
 The rationale includes the (1) reasons
for focusing on your stated objectives,
and hypotheses and (2) reasons for
choosing the materials and methods
you propose to use.
 The significance includes both the
applied and basic significance of your
research—that is, how will the world be
different after your research is
completed?
Rationale and significance
Objectives
 Objectives are the achievable,
outcome-based aims of your research,
and should be presented as concise
statements that describe what you plan
to accomplish by your research
activities. The objectives describe what
you will do to determine whether your
hypotheses are true.
 Under this heading you need to write
create two sub heading, general
objective and specific objective.
Example of the Objectives
 To analyze the quantity of total
isoflavones in soybean (Glycine
max) and lentils [Mung bean
(Vigna radiata) and Masoor dahl
(Lens culinaris)].
 To investigate the association of
the Follicular stimulating hormone
(FSH), with the type and quantity
of isoflavones.
Methods and Materials
 The methods section will vary
depending on the type of research or
project you propose (e.g., field
research, laboratory study, computer
simulation, case study, etc.)
 In general, should describe the
techniques you will use in sufficient
detail to allow the reader to judge
whether the project will achieve the
stated objectives.
Methods and Materials
 This may include
a description of your study area
type of equipment or software you
will use
laboratory procedures
statistical methods
experimental design (e.g., variables
to be measured, randomization
scheme, and replication).
Methods and Materials
The methods section must describe the:
Proposed experiments or
investigations.
Materials and techniques that you will
use, including their feasibility.
Statistical techniques and other
methods used to analyze the data
Methods and Materials
 It can be include following sub
headings
−Study type
−Study place and population
−Sample size and sampling procedure
−Data collection procedure
−Analysis plan
Ethical consideration
 In this section will describe the
ethical issues you need to
address. How those ethical issues
will be addressed. In this section
you need to mention the ethical
review board, from where your
proposal will be reviewed.
Conceptual Framework
 A conceptual framework is used to
illustrate what you expect to find
through your research, including
how the variables you are
considering might relate to each
other. You should construct one
before you actually begin your
investigation. Sample conceptual
framework
Conceptual Framework
References
 The list of references should be
at the end of the proposal
 List names of all authors, the
title of the publication, the
name of journal, year, volume,
page numbers
Referencing Styles
The following are the most popular:
APA (American Psychological
Association). APA is an author/date based
style. This means emphasis is placed on the
author and the date of a piece of work to
uniquely identify it.
MLA (Modern Language
Association). MLA is most often applied by
the arts and humanities, particularly in the
USA. It is arguably the most well used of all
Referencing Styles
The following are the most popular:
Harvard. Harvard is very similar to APA. Where
APA is primarily used in the USA, Harvard
referencing is the most well used referencing
style in the UK and Australia, and is encouraged
for use with the humanities.
Vancouver. The Vancouver system is mainly
used in medical and scientific papers.
Chicago and Turabian. These are two
separate styles but are very similar, just like
Harvard and APA. These are widely used for
history and economics.
Referencing Styles
Student should use the style of the university and tutor
recommend and must not mix-and-match.
Plagiarism
If you quote or paraphrase another author's work without
including a reference to it you are plagiarising. Not only is it
very easy to detect plagiarism using online services like Turn
It In, but it is also very easy for your tutor to spot it just by
reading your work. Remember - you are not being marked
on your ability to write facts or show off what you know.
Any assumptions or facts you state must have someone
else's credible work to back you up. Plagiarism does not
only mean cheating, it is mainly used to describe forgetting
or not realizing to include a reference to other's work or
theories.
Timeline/Plan of Work
 Many proposals also include a schedule
with anticipated completion dates for
specific parts of the dissertation.
 This timeline helps your committee
determine if your project is realistic given
available methods and institutional
requirements (such as deadlines for
submission, etc.).
 Setting a schedule can also help you
manage your time more effectively by
setting specific goals for yourself.
Example of Timeline/Plan of Work
Budget
 In this section will describe the
budget you need to carry out for
your research.
Instructions for text development
 Font Name: Times New Roman
 Font size: 12pt
 Line space: 1.5pt
 Paragraph space: 6pt up
 Upper, lower and right margin: 1”
 Left margin: 1.25”
Document size will be maximum 12 pages
 Allow you to review and critically
evaluate the published literature of
your interested topic.
 Develop novel ideas during writing
proposal.
 Convince yourself and others that your
research is worth doing.
 Keep you focused on your research
work.
Benefits of Writing Proposal
Writing Stages
2. Writing the First Draft2. Writing the First Draft
4. Finishing4. Finishing
3. Revising, Revising, Revising3. Revising, Revising, Revising
1. Getting in the Mood1. Getting in the Mood
Save multiple copies
of your draft
Assessment of thesis proposal
 Proposal will be asses through formative
assessment.
 All of the students will give a formal
presentation on their protocol.
 Department will arrange the date and
venue of the presentation. Along with
departmental assessor an examiners will
be present in the presentation session
from other related department.
Assessment of thesis proposal
 Student will acquire 4 credits by
successful completion of presentation
and discussion.
 After completion formal presentation
student need submit their proposal to
the institutional review board (IRB) of
the Institute for ethical approval of the
research.
 Data collection can be started after
getting ethical clearance from the IRB
Conclusions
 Developing, and communicating a
research protocol is a sophisticated
and time-consuming process.
 It is important to understand the
steps in developing a research
protocol in order to perform an
appropriate study and obtain
reliable results.
Thank YouThank You

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Protocol presentation-slideshare

  • 1. How to develop a Research Protocol ? Dr. Farzana Saleh Ph.D. Associate Professor of CN Bangladesh University of Health Sciences
  • 2. Differences between Research Protocol and Research Proposal  A research protocol is a detailed set of activities for the proposed project and these activities are supported by evidence from other research and from the preliminary investigations.  A research proposal is a concise and clear summary of the proposed research. SYNOPSIS.
  • 3. What is Research?  A methodical investigation, involving the collection of information (data), to solve a problem or contribute to knowledge about a theory or practice.  Research is critical in medicine because it leads to new discoveries and can change peoples’ lives by improving health and well being.
  • 4. What is Research?  Research helps to provide scientific understanding and solves practical problems.  Relies on methods and principles that will produce reliable and supportable results.  All research starts with an idea or question based on personal experiences.
  • 5. Research (cont.)  careful or attentive search  studious inquiry or examination  especially : investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws  the collecting of information about a particular subject
  • 6. Scientific Approach  The most sophisticated method of acquiring knowledge is - scientific approach. Combines important features of induction and deduction together with other methods to create a system of acquiring knowledge.  Generally more reliable than other methods.  Approach used most often to perform medical or public health research.
  • 7. Scientific research is an integrated approach of deduction and induction Deduction Hypothesis generation Testing the hypothesis Induction (Inference on hypothesis) generalization of the results In sample population Universe known truths
  • 8. Causal model of risk factors for CVDCausal model of risk factors for CVD Morbidity and Mortality (Stroke, MI) Biological Risk Factors (Hypertension, Blood Lipids, Homocysteine) Genetic Risk Factors (Family History) Behavioral Risk Factors (Cigarette, Diet, Exercise) Environmental Factors (Socioeconomic Status, Work Environment)
  • 10.  What is your question ?  Why is your study important ?  How are you going to do it ?39 Key Points of Your Proposal
  • 11. Choosing a topic  Should be interesting – to investigator, funding agency, journal editors, consumers (colleagues, public health researcher)  Relevance- add new information to the scientific world  Simple and manageable in scope (feasibility in terms of money, time, manpower)  Expected results likely to alter clinical or health policy decisions in future
  • 12. The GOOD IDEA must be  Feasible  Do-able by you  Do-able at your institution, hospital & community  Acceptable to your institution  In conformity with human welfare policies  Conceptually significant
  • 13. Steps in conduct of research planning and execution The first and foremost is formulating a research question, the most challenging part
  • 14. Identify the Question Sources for identifying the question or problem: Personal experiences Literature review Theories Ideas from others
  • 15. Identify the Question Criteria for evaluating the question: Significance Convenience Feasibility Interest to researcher
  • 16. Research question  IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION.  IT SHOULD BE CLEAR DEFINITE AND SPECIFIC.
  • 17. What to have in a complete study protocol ?  Title  Abstract  Introduction a)Rationale b)Hypothesis/ Research question  Literature Review  Study Objectives
  • 18. What to have in a complete study protocol ?  Methods and materials a)Ethical consideration  Time line/ Plan of work  Reference  Budget
  • 19. Title must reflect the central theme: selling point Attractive and easy to understand Concise and Informative: avoid non-informative words like “ A study of---” Title
  • 20. Bioavailability and Health Effects of Isoflavones from Bangladeshi Soybean and Lentils in Postmenopausal Women Example of a Title
  • 21. 1. Title of your Research Proposal 2. Name of the Supervisor (s) 3. Name of the Principal Investigator (PI) 4. Name of the Co-investigators (if you want or have) 5. Place of the Study 6. Duration of the Study Contents of a Title Page
  • 22. Thesis protocol should have abstract section. The abstract should- a)Provide a brief overview of the proposal that gives a reader a basic understanding of the proposal and encourages her or him to read more. Abstract
  • 23. b) Summarize − Introduction − Statement of the Problem − Research Questions or Hypotheses − Methods − Expected Results − Expected Conclusions Abstract
  • 24. Example of a Abstract
  • 25. Introduction  Study protocol should have introduction/Background section.  The introduction helps put your project in conversation with other projects on similar topics.  Generally, the introduction provides necessary background information to your study and provides readers with some sense of your overall research interest.
  • 26. Introduction A good introduction should: Establish the general ground (real world or research) in which the research is placed. Describe the broad foundations of your study, including some references to existing literature and/or empirically observable situations.
  • 27. Introduction  In other words, the introduction needs to provide sufficient background for readers to understand where your study is coming from.  Indicate the general scope of your project, but do not go into so much detail that later sections (purpose/literature review) become irrelevant.
  • 28. Literature Review: In your review of literature you are expected to do the following: 1. Place one's original work in the context of existing literature. 2. Interpret the major issues surrounding your topic. 3. Describe the relationship of each work to the others under consideration. 4. Identify new ways to interpret, and shed light on any gaps in previous research.
  • 29. Literature Review: In your review of literature you are expected to do the following: 5. Resolve conflicts among seemingly contradictory previous studies. 6. Determine which literature makes a significant contribution to the understanding of your topic. 7. Point the way to further research on your topic.
  • 30. Literature Review: Contents  The Literature Review  must be well structured  your ideas must flow logically from one point to the next.  Ensure sources and references are current and relevant, cited appropriately according to your discipline.  Present terminology and viewpoints on the topic in an balanced and comprehensive manner.
  • 31. Literature Review: Contents Include the following content in your Literature Review: Provide an overview of the subject, issue, or theory under consideration. Divide outside works into categories and concepts. Connect the works to what has come before your work and ideas. Provide conclusions about those works that make the greatest contribution to the understanding and development of your subject.
  • 32. Literature Review: Considering the points  Qualifications: What are the author's credentials to make the judgments he or she has made?  Neutrality: Is the author's perspective even-handed or biased?  Credibility: Which of the author's theses are convincing and why?  Worth: Do the author's conclusions add to the value of your own?
  • 33. Literature Review: Considering the points  Your transitions between ideas analyze, synthesize, and assess these outside perspectives, and do not simply summarize or translate them.
  • 34. Literature Review: Way of the presentation  Selecting and quoting only the most relevant material for your subject and argument.  Making sense of the quotation within the context of your argument.  Introducing and integrating only relevant quotations into your literature review.  Focusing on the language of quotations in the interpretations.
  • 35.  Every research work must have research question (s)/hypothesis.  A Research question is a statement that identifies the phenomenon to be studied  Many studies have more than one research question. Hypothesis/ Research questions
  • 36.  Research Question: What is the quantity of total isoflavones in locally available soybean (Glycine max) and lentils [Mung bean (Vigna radiata) and Masoor dahl (Lens culinaris)]?  Hypothesis: Isoflavones from Bangladeshi soyabean and lentils have beneficial effects on health among postmenopausal women and it has an association with the levels of follicular stimulating hormone (FSH). Example: Hypothesis/ Research questions
  • 37.  In this section you need to explain why your research is important?  Any novel ideas or contributions that the proposed project offers should also be discussed. Rationale and significance
  • 38.  The rationale includes the (1) reasons for focusing on your stated objectives, and hypotheses and (2) reasons for choosing the materials and methods you propose to use.  The significance includes both the applied and basic significance of your research—that is, how will the world be different after your research is completed? Rationale and significance
  • 39. Objectives  Objectives are the achievable, outcome-based aims of your research, and should be presented as concise statements that describe what you plan to accomplish by your research activities. The objectives describe what you will do to determine whether your hypotheses are true.  Under this heading you need to write create two sub heading, general objective and specific objective.
  • 40. Example of the Objectives  To analyze the quantity of total isoflavones in soybean (Glycine max) and lentils [Mung bean (Vigna radiata) and Masoor dahl (Lens culinaris)].  To investigate the association of the Follicular stimulating hormone (FSH), with the type and quantity of isoflavones.
  • 41. Methods and Materials  The methods section will vary depending on the type of research or project you propose (e.g., field research, laboratory study, computer simulation, case study, etc.)  In general, should describe the techniques you will use in sufficient detail to allow the reader to judge whether the project will achieve the stated objectives.
  • 42. Methods and Materials  This may include a description of your study area type of equipment or software you will use laboratory procedures statistical methods experimental design (e.g., variables to be measured, randomization scheme, and replication).
  • 43. Methods and Materials The methods section must describe the: Proposed experiments or investigations. Materials and techniques that you will use, including their feasibility. Statistical techniques and other methods used to analyze the data
  • 44. Methods and Materials  It can be include following sub headings −Study type −Study place and population −Sample size and sampling procedure −Data collection procedure −Analysis plan
  • 45. Ethical consideration  In this section will describe the ethical issues you need to address. How those ethical issues will be addressed. In this section you need to mention the ethical review board, from where your proposal will be reviewed.
  • 46. Conceptual Framework  A conceptual framework is used to illustrate what you expect to find through your research, including how the variables you are considering might relate to each other. You should construct one before you actually begin your investigation. Sample conceptual framework
  • 48. References  The list of references should be at the end of the proposal  List names of all authors, the title of the publication, the name of journal, year, volume, page numbers
  • 49. Referencing Styles The following are the most popular: APA (American Psychological Association). APA is an author/date based style. This means emphasis is placed on the author and the date of a piece of work to uniquely identify it. MLA (Modern Language Association). MLA is most often applied by the arts and humanities, particularly in the USA. It is arguably the most well used of all
  • 50. Referencing Styles The following are the most popular: Harvard. Harvard is very similar to APA. Where APA is primarily used in the USA, Harvard referencing is the most well used referencing style in the UK and Australia, and is encouraged for use with the humanities. Vancouver. The Vancouver system is mainly used in medical and scientific papers. Chicago and Turabian. These are two separate styles but are very similar, just like Harvard and APA. These are widely used for history and economics.
  • 51. Referencing Styles Student should use the style of the university and tutor recommend and must not mix-and-match. Plagiarism If you quote or paraphrase another author's work without including a reference to it you are plagiarising. Not only is it very easy to detect plagiarism using online services like Turn It In, but it is also very easy for your tutor to spot it just by reading your work. Remember - you are not being marked on your ability to write facts or show off what you know. Any assumptions or facts you state must have someone else's credible work to back you up. Plagiarism does not only mean cheating, it is mainly used to describe forgetting or not realizing to include a reference to other's work or theories.
  • 52. Timeline/Plan of Work  Many proposals also include a schedule with anticipated completion dates for specific parts of the dissertation.  This timeline helps your committee determine if your project is realistic given available methods and institutional requirements (such as deadlines for submission, etc.).  Setting a schedule can also help you manage your time more effectively by setting specific goals for yourself.
  • 54. Budget  In this section will describe the budget you need to carry out for your research. Instructions for text development  Font Name: Times New Roman  Font size: 12pt  Line space: 1.5pt  Paragraph space: 6pt up  Upper, lower and right margin: 1”  Left margin: 1.25” Document size will be maximum 12 pages
  • 55.  Allow you to review and critically evaluate the published literature of your interested topic.  Develop novel ideas during writing proposal.  Convince yourself and others that your research is worth doing.  Keep you focused on your research work. Benefits of Writing Proposal
  • 56. Writing Stages 2. Writing the First Draft2. Writing the First Draft 4. Finishing4. Finishing 3. Revising, Revising, Revising3. Revising, Revising, Revising 1. Getting in the Mood1. Getting in the Mood Save multiple copies of your draft
  • 57. Assessment of thesis proposal  Proposal will be asses through formative assessment.  All of the students will give a formal presentation on their protocol.  Department will arrange the date and venue of the presentation. Along with departmental assessor an examiners will be present in the presentation session from other related department.
  • 58. Assessment of thesis proposal  Student will acquire 4 credits by successful completion of presentation and discussion.  After completion formal presentation student need submit their proposal to the institutional review board (IRB) of the Institute for ethical approval of the research.  Data collection can be started after getting ethical clearance from the IRB
  • 59. Conclusions  Developing, and communicating a research protocol is a sophisticated and time-consuming process.  It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results.