How to develop a Research Protocol ?

Dr.Shaik Shaffi Ahamed Ph.D.,

Assistant Professor

Department of Family & Community Medicine

College of Medicine

King Saud University

This session ---------

By the end of this session, you will be able to:• Understand what is Research ?• Identify the components of a research protocol• Explain the role of each part within the overall

process of protocol development• Understand the importance of research protocol• Able to write a research protocol

What is Research? A systematic investigation, involving the

collection of information (data), to solve aproblem or contribute to knowledge about a theory or practice.

Research is critical in medicine because itleads to new discoveries and can changepeoples’ lives by improving health and well being.

Research helps to provide scientificunderstanding and solves practical problems.

Research (cont.)

Relies on methods and principles that willproduce credible and verifiable results.

All research starts with an idea or questionbased on personal experiences.

Scientific Approach

The most sophisticated method of acquiringknowledge is by scientific approach.

Combines important features of inductionand deduction together with other methodsto create a system of acquiring knowledge.

Generally more reliable than other methods.

Approach used most often to performmedical research.

Scientific researchis an integrated approach of deduction and induction

DeductionHypothesis generation

Testing the hypothesis

Induction(Inference on hypothesis)generalization of the results

In sample population

Universe

known truths

Policy making, planning,Management evaluation

Health systems research

Epidemiological

Biomedical

Statistical

Behavioral

Social & economic

MODEL OF THE RELATIONSHIP BETWEEN DIFFERENT TYPES OF RESEARCH

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)

Preventable Causes of Disease

BEINGS • Biological factors and Behavioral Factors

• Environmental factors

• Immunologic factors

• Nutritional factors

• Genetic factors

• Services, Social factors, and Spiritual factors[JF Jekel, Epidemiology, Biostatistics, and Preventive Medicine, 1996]

Clinical issues and questions in the practice of medicine

Issue Question

Normality/abnormality Is a person sick or well? What abnormalities are

associated with having a disease ?

Diagnosis

How accurate are diagnostic tests or strategies used to find a disease ?

Frequency How often does a disease occur ?

Risk What factors are associated with an increased likelihood of disease ?

Prognosis What are the consequences of having a disease ?

Treatment How does treatment change the future course of a disease ?

Prevention Does intervention on people without disease keep disease from arising?

Does early detection and treatment improve the course of disease ?

Cause What conditions result in disease ?

What are the pathogen tic mechanisms of disease ?

Protocol writing

What is your question ?

Why is your study important ?

How are you going to do it ?

Key Points of Your Proposal

Choosing a topic • Should be interesting – to investigator, funding agency,

journal editors, consumers (colleagues, public, medical community), etc.

• 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 Practicality Feasibility Interest to researcher

RESEARCH QUESTION

IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION.

IT SHOULD BE CLEAR UNAMBIGUOUS AND SPECIFIC

RESEARCH QUESTION

• IS DRUG “A” BETTER THAN DRUG “B” IN THE MANAGEMENT OF HEPATIC FAILURE IN PATIENTS WITH CIRROSIS?

• IS ALCOHOLISM RELATED TO THE DEVELOPMENT OF CIRROSIS LIVER?

What to have in a complete study protocol ?

• Title• Summary• Background (Literature Review), Preliminary

Studies, and Justification/Rationale • Study Objectives and/or Questions• Testable Hypotheses• Study Design• Study Population and Methods of Recruitment• Variables List and Sample Size

• Methods of Data Collection• Data Collection Tools• Plan of Analysis• Timeline• Issues for Ethical Review &

Approvals• Operational Planning and Budgeting• Plan of Dissemination/Results

Reporting• References

Title

• Title must reflect the central theme:selling point

• Attractive and easy to understand

• Concise and Informative: avoid non-informative words like “ A study of---”

Background

• Briefly sketch the background of the proposal.

• Critically evaluate the existing knowledge – What is the general situation and how is the

problem developing? – Will it grow rapidly if unchecked? – What has been done so far to address the

problem and with what effect?

• Specifically identify the gaps the proposed research is intended to fill.

– What do you propose to do? – Explain why it is a good idea ?• State concisely the importance of your research

Significance• State concisely and clearly the importance of your

study.• Emphasize on any novelty or innovation• Convey the significance of your research to

–1) scientific contribution –2) improving in public health –3) change in health policies–4) change in patient care– etc.,

Study Objectives

State the objectives of the proposal:

Describe concisely and realistically what the specific research is intended to accomplish

Avoid grandiose designs- Over-ambitious proposals that aim to do everything – burdens, determinants, prevention and control of….

Specify clear objectives

• Objective -examples • To study whether SNP markers are associated with obesity and hypertension phenotypes. To assess the general population knowledge &

attitude towards Organ donation To identify the risk factors for Type-II diabetes • Hypotheses Any hypotheses to be tested.• • Have clear hypotheses• • State hypotheses in form of short bulleted list• • Avoid narrative paragraphs

Hypothesis and Specific Aims

• List the specific aims one by one concisely

• Not too many aims; 2-4 best

• Be specific, no general and ambiguous statements

• Be realistic, no unachievable aims

• Aims should be logically linked and arranged accordingly; testing your hypothesis

When you divide a section into subsections, all the pieces should be of the same pie

• Hypothesis-example

• We hypothesize that standard care plus new intervention

(additional drug) will be superior to standard care alone in

reducing CVD mortality among patients with preexisting

heart disease.

• We hypothesize that prophylaxis with inhaled

drug A will be superior to oral preparation of

drug B in preventing acute exacerbation of

reactive airway disease.

• We hypothesize that low birth weight is an

independent risk factor for type II diabetes.

What is your question

Hypothesis

Why is your study important

Significance

How are you going to do it

Research design

Key Points of Your Proposal

Develop the Study Design

• A study design is the researcher’s overall planto obtain the answer (s) to the question beingasked and the hypothesis being tested

• It spells out strategies to develop informationthat is accurate, objective and meaningful

• It explains methods that will be used to collectand analyze data

• Study Design

• Describe the overall design of the study, example:

• This is a randomized, double blind placebo controlled trail.

• This is a cross sectional survey

Research Designs Purpose Study Design

To determine frequency & burden of a disease

* Cross sectional survey (Prevalence)

* Cohort study (Incidence)

To identify the risk factors * Cohort study

* Case-Control study

To determine prognosis of a disease

* Cohort study

To determine efficacy/ effectiveness of new treatment * Clinical trials

*Community intervention

To evaluate community programs * Evaluation

Feasibility- Study subjects

• What is the estimated sample size?

• Who is the study subject (case definition)?

• Selection criteria (inclusion & exclusion)

• How they are sampled ? (sampling)

• Time span for meeting the sample size

Can we meet the sample size?

• Estimated sample size (based on the research hypothesis, outcome variable)

• Estimated subjects likely to be available for recruitment

• Estimated subjects likely to refuse

• Estimated subjects likely to be lost to follow up

Study Population and Method ofRecruitment

-- Describe clearly what type of subjects will be studied

-- How will they be identified

-- Inclusion and Exclusion criteria

-- Describe each step involved in recruitment of study subjects

-- Describe the role of research personnel in this process

-- Mention “informed consent”

Variables List

• State all the information that is to be collected

(demographic data, clinical and lab data) in detail.

Method of data collection

• Explain precisely when and how the data will be collected, and measured (units).

• Explain method of ensuring quality control

Data Collection Tools

• Explain why a particular tool is being used to collect the data. For instance, if a survey questionnaire is being used explain reliability and validity of the instrument.

• Pretest

Analyzing the Data

Upon completion of the study, data should be analyzed

List out the appropriate statistical tests based on the type of data

Plan of analysis

• List the names of variables that will be used in the analyses.

• State the name of statistical analysis that will be

performed to assess the outcome.

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.

Benefits of Writing Proposal

• 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.

Writing Stages

2. Writing the First Draft2. Writing the First Draft

4. Finishing4. Finishing3. Revising, Revising, Revising3. Revising, Revising, Revising

1. Getting in the Mood1. Getting in the Mood

Save multiple copies of your draft

Conclusions• Developing, and communicating a

research protocol is a sophisticated and time-consuming process.

It is important to understand the steps indeveloping a research protocol in order toperform an appropriate study and obtainreliable results.

Thank You