Research Design

There are basically two types of research study designs:

1. Observational Study
2. Experimental or Interventional Study

1.  Observational Study

Observational Study is a study in which the researcher only observes what is happening or what has happened in the past and tries to draw conclusion based on these observations. In observational studies, researchers don’t assign choices; they simply observe choices and their results. Observational studies can be retrospective (study things that happened in the past) or prospective (identify subjects in advance and collect data as events unfold)

Types of Observational Study Design:

• Descriptive Study Designs

1. Case Report: Single Case
2. Case Series: Collection of similar cases 
3. Cross-sectional (descriptive): Single sample from a larger population – there is no comparison

• Analytical Study Designs

1. Cross-sectional (analytical): Single sample from larger population- compares two or more groups in the sample
2. Case-control: Compares risk factors between diseased (cases) and non-diseased (controls) groups
3. Cohort: Compares outcomes between groups exposed and non-exposed to risk factors for a disease

• Ecological Study: correlational study design with populations as the unit of study

2.  Experimental Study

Experimental studies are the studies designed to assess the effect of particular variables on a phenomenon by keeping the other variable constant or control. The researcher has control over the exposure; he/she not only just observes the situation and records it; but also manipulates the situation and measures the effect of manipulation. 

Types of Experimental/Interventional studies:

• As per control: Randomized Control Trial/Non-randomized Control Trial 
• As per Blinding: Single/Double/Triple Blind
• As per Area: 

1. Field: study carried out into different groups and the intervention is performed on the individual basis. 
2. Community trial: study is conducted into different groups and intervention is performed on community basis; unit of analysis is entire communities such as VDCs, districts, etc. 
3. Clinical: Investigator allots the subjects to different groups – intervention versus non-intervention; Randomized Control Trial 
4. Lab: studies conducted in lab settings

• Differences between Observational and Experimental Studies

A.  Cross-sectional Design

Cross-sectional study is generally an observational study in which both exposure and outcomes are measured at the same time, information is obtained from the study subjects only once no follow up is required; provides a snap shot of the health problem of the population at a particular point of time. The data of cross-sectional study can be used to assess the prevalence of acute or chronic conditions in a population. Usually, cross-sectional studies are descriptive by nature, only sometime (rarely) analytic.

Types of cross-sectional study:

- Descriptive cross-sectional

- Analytical cross-sectional

B.  Case Control Study

Case control studies, often called “retrospective studies” are a common first approach to test causal hypothesis. This design is generally used to find out the cause/exposure for rare diseases. There are three distinct features of this study design:

1. Both exposure (cause) and outcome (disease) have occurred before the start of the study
2. The study proceeds backward from effect to cause
3. It uses a control or comparison group to support or refute an inference

C.  Cohort Study

Cohort study is an observational analytic study, where enrolments of subjects in to the study are based on their exposure characteristics or membership in a group or healthy population, where disease, death or other health-related outcomes are ascertained and then compared. A group of disease free population or at risk population is followed over time-period to find out the relationship or an association between risk factors/cause and disease/effect based on their current exposure status. This design is generally used to find out the disease/effect for rare cause/exposure.

The distinguishing features of cohort studies are:

1. Cohorts are identified prior to the appearance of the disease under investigation
2. The study groups, so defined, are observed over a period of time to determine the frequency of disease among them
3. The study proceeds forward from cause and effect

D.  Randomized Controlled Trial (RCT)
RCT is a systematic study on investigating agent (drug/vaccine) in a human subject in order to discover or verify the effects or to find out the adverse effect of the investigating agent in order to determine the efficacy and safety. It is a prospective experimental study using primary data generated in the clinical and controlled environment following strict protocol.

Basic steps in conducting RCT:

1. Drawing up a protocol
2. Selecting reference and experimental populations
3. Randomization
4. Manipulation or intervention
5. Follow-up
6. Assessment of outcome

Figure: Design of Randomized Controlled Trial (RCT)

Concept of Blinding

The potential for bias is an important issue in experimental studies. The protection against these forms of bias is best achieved by use of blinding. Blinding is a process of assigning treatment to participants in such a way so that actual treatment assignment is not known to certain persons. Blinding can be done in three ways:

1. Single Blinding: The trial is so planned that the participant is not aware of whether he/she belongs to the study group or control group.

2. Double Blinding: The trial is so planned that neither the doctor nor the participant is aware of the group allocation and the treatment received.

3. Triple Blinding: The participant, the investigator and the person analyzing the data are all blind.

Research Protocol

The Structure of a Research Protocol

·        Title

·        Abstract/Summary

·        Introduction

a.      Background

b.      Problem statement / Rationale of the study

c.      Objectives of the study

d.      Research question(s)/ Research Hypothesis

e.      Conceptual framework

f.       Study variables

g.      Operational Definitions

·        Methodology

a.      Study design

b.      Study setting

c.      Study population and unit of analysis

d.      Sampling procedure and sample size

e.      Data collection, analysis and interpretation

                                                    i.     Tools and techniques of data collection

                                                   ii.     Validity and reliability of tools

                                                  iii.     Data collection procedure

                                                  iv.     Data entry, analysis and interpretation

f.       Plan for supervision and monitoring

g.      Expected outcome of the research results

h.      Plan for dissemination of study findings

i.       Limitations of the study

·        Significance of the Study

·        Resources Requirements

·        Study Plan/ Work Plan

·        Budget

·        References/Bibliography

·        Appendices

a.      Work Plan (Gantt Chart)

b.      Definition list

c.      Summary table of study visits / procedures

d.      Study Tools (Questionnaires) / letters / recruitment documentation

e.      Informed consent documentation

Research Hypothesis

Based on the experience with the study problem, it might be possible to develop explanations for the problem, which can then be tested. If so, hypotheses can be formulated in addition to the study objectives.

A HYPOTHESIS is a prediction of a relationship between one or more factors and the problem under study that can be tested. It is an idea or explanation of something that is based on a few known facts but that has not yet been proved to be true or correct. However, hypothesis is not necessary for descriptive studies while it is compulsory for analytical studies.

There are generally two types of hypotheses:

1. Null Hypothesis: Null the hypothesis that there is no significant difference between specified populations, any observed difference being due to sampling or experimental error. It is denoted by H₀

2. Alternate Hypothesis: The alternative hypothesis, denoted by H₁ or H_a, is the hypothesis that proposes a relationship between two or more variables. It is also considered as research hypothesis.

Examples:

Before people used to believed that the world was flat. Researcher doubted this statement and performed research based on the shape of the earth, then the hypothesis of this study could be:

o   Null hypothesis,           H₀: The world is flat.

o   Alternate hypothesis,   H₁: The world is round.

If we are doing analytical study on relationship between sun exposure and Ocular surface squamous neoplasia (OSSN), then the hypothesis will be:

o   H_o: Sun exposure does not increase the susceptibility to OSSN

o   H_a: Sun exposure increases the susceptibility to OSSN

Research Objectives

Research objectives describe what will be demonstrated, tested, evaluated, confirmed or compared. The objectives of a research project summarize what is to be achieved by the study. Objectives should be closely related to the statement of the problem. The formulation of objectives will help to:

• Focus the study or narrowing it down to essentials
• Avoid collection of data fact and not strictly necessary for understanding and solving the identified problem
• Organize the study in clearly defined parts or phases

Properly formulated, specific objectives will facilitate the development of your research methodology and will help to orient the collection, analysis, interpretation, and utilization of data.

Criteria of Research Objectives

• It should be closely related to the statement of the problem and should cover the different aspect of the problems and its contributing factors in a coherent way and in a logical sequence.
• It should be clearly phrased in operational terms specifying exactly.

                 o What you plan to do?
                 o To whom it will be done?
                 o When it will be done?
                 o For what purpose?

• It should be realistic and measurable
• It should have action verbs that are specific enough to be evaluated; for e.g. to determine, to compare, to verify, to calculate, to describe, and to establish. 
• Avoid the use of vague non-action verbs such as: to appreciate, to understand, or to study
• Keep in mind that when the project is evaluated, the results will be compared to the objectives. If the objectives have not been spelled out clearly, the project cannot be evaluated.
•  Overall, research objectives should be SMART, that is:

                      o   S     = Specific

o   M    = Measurable

o   A     = Attainable, achievable

o   R     = Relevant, result-oriented, realistic, reliable

o   T     = Timely, time-bound

Types of Objectives

    1. General Objectives

    2. Specific Objectives

1) General Objective: It is stated in one or two sentences outlining the broad prospective of the study in general terms. The general objective of a study states what researchers expect to achieve by the study in general terms.

For example, if the problem identified is low utilization of child welfare clinics, the general objective of the study could be:

- to identify the reasons for this low utilization of child welfare clinics by mothers in Dhanusha District

2) Specific Objectives: It is possible (and advisable) to break down a general objective into smaller, logically connected parts. These are normally referred to as specific objectives. They should specify what you will do in your study, where and for what purpose.

Continuing the previous example of general objective, example of specific objectives could be:

a) To determine the level of utilization of child welfare clinic by the mothers

b) To identify the factors related to the child welfare services offered that encourage mothers to utilize the services

c) To identify socioeconomic and cultural factors that may influence the utilization of child welfare services by the mothers

Reviewing the Literature

Once the problem is formulated, the researcher should undertake extensive literature survey connected with the problem and perform critical review of previous studies. Reviewing the literature expands upon the reasons for selecting a particular research question and allows the researcher to get himself acquainted with the selected problem. Not only facilitating the problem statement of our research, but also for gaining methodological knowledge and expertise, reviewing the literature is an important step in research process.

Literature can include a range of sources:

- journal articles

- monographs

- computerized databases

- conference proceedings, seminar papers

- dissertations

- empirical studies

- government reports and reports from other bodies’

- historical records

- statistical handbooks

Importance of reviewing the literature in research process are as follows:

• Reviewing previous studies helps the researcher know of what is happening in the field
• It supports in gaining a level of topical and methodological knowledge and expertise
• It helps in finding potential gaps in the literature/previous studies that may point to potential research questions
• Critically evaluating common/typical methods
• Facilitating the development of your own methodological approaches

Selection of Research Problem

1. Formulating the Research Problem:

A research problem, in general, refers to some difficulty which a researcher experiences in the context of either a theoretical or practical situation and wants to obtain a solution for the same.

Research Problem is an unanswered question that a researcher might encounter in the context of either a theoretical or practical situation.

• Components of a Research Problem:

1. There should be an individual or a group who have some difficulty or problem
2. There should be some objective to be pursued (A person or an organization who wants nothing cannot have a problem)
3. There should be more than one alternative means available to the Researcher.
4. There should be some doubt in the mind of the Researcher about the choice of alternative means.

Operational Research in Health

Types of Research

1. Descriptive vs. Analytical: Descriptive research includes surveys and fact-finding inquiries of different kinds. The major purpose of descriptive research is description of the state of affairs as it exists at present. The main characteristic of this method is that the researcher has no control over the variables; he can only report what has happened or what is happening. for example, Prevalence study of night blindness among older population in Pokhara, Kaski.

In analytical research, on the other hand, the researcher has to use facts or information already available and analyze these to make a critical evaluation of the material. It involves the in-depth study and evaluation of available information in an attempt to explain complex phenomenon. E.g. Study on effect of sunlight exposure and Ocular surface squamous neoplasia.

Descriptive research attempts to determine, describe, or identify what is, while analytical research attempts to establish why it is that way or how it came to be.

2.   Applied vs. Fundamental: Research can either be applied (or action) research or fundamental (to basic or pure) research. Applied research aims at finding a solution for an immediate problem facing a society or an organization, whereas fundamental research is mainly concerned with generalizations and with the formulation of a theory. E.g. Study on management of Polio epidemic in Nepal.

    “Gathering knowledge for knowledge’s sake is termed ‘pure’ or ‘basic’ research.” Research concerning some natural phenomenon or relating to pure mathematics are examples of fundamental research. For e.g. Formulation of gravitational theory

Similarly, research studies, concerning human behavior carried on with a view to make generalisations about human behaviour, are also examples of fundamental research, but research aimed at certain conclusions (say, a solution) facing a concrete problem is an example of applied research.

3.   Quantitative vs. Qualitative: Quantitative research is based on the measurement of quantity or amount. It is applicable to phenomena that can be expressed in terms of quantity. E.g. Prevalence of trachoma in Bharatpur, Nepal. Qualitative research, on the other hand, is concerned with qualitative phenomenon, i.e., phenomena relating to or involving quality or kind. For instance, when we are interested in investigating the reasons for human behaviour (i.e., why people think or do certain things), we quite often talk of ‘Motivation Research’, an important type of qualitative research. Attitude or opinion research i.e., research designed to find out how people feel or what they think about a particular subject or institution is also qualitative research.

4.   Conceptual vs. Empirical: Conceptual research is that related to some abstract idea(s) or theory. It is generally used by philosophers and thinkers to develop new concepts or to reinterpret existing ones.
On the other hand, empirical research relies on experience or observation alone, often without due regard for system and theory. It is data-based research, coming up with conclusions which are capable of being verified by observation or experiment.

5.   Experimental Research: Experimental research is a study that strictly adheres to a scientific research design. It includes a hypothesis, a variable that can be manipulated by the researcher, and variables that can be measured, calculated and compared. Most importantly,  experimental research is completed in a controlled environment. The researcher collects data and results will either support or reject the hypothesis. This method of research is referred to a hypothesis testing or a deductive research method. E.g. Study on short-term use of topical corticosteroid eye drops for management of pterygium

6. Operational Research: This research type aims to discuss and study a recurring problem in an organization which may involve a study of concretization of the organization’s mission, vision, philosophy, and goals. E.g. Success with antiretroviral treatment for children in Accham: experience with health center / nurse-based care

7.   Action Research: Action research is undertaken to address a recurring problem in an organization immediately, usually a part of a major problem is addressed in this type of research. For e.g. Ways to improve the health workers performance in Geriatric Hospitals.

8.      Some Other Types of Research:

• Form the point of view of time, we can think of research either as one-time research or longitudinal research.
• Research can be field-setting research or laboratory research or simulation research, depending upon the environment in which it is to be carried out.
• Historical research is that which utilizes historical sources like documents, remains, etc. to study events or ideas of the past, including the philosophy of persons and groups at any remote point of time. E.g. Development of Ophthalmic Science in Nepal.

Introduction to Research

The word research was coined from a French word “CERCHIER” meaning “to seek or to search”. Thus, research is an attempt to solve or gain a solution to a problem.

• What is Research???

- Research is “the process of systematically obtaining accurate answers to significant and pertinent questions by the use of the scientific method of gathering and interpreting information”.(Balsley & Clover)

- A systematic, controlled, empirical and critical investigation of hypothetical propositions about the presumed relations among natural phenomenon. (Kerlinger, 1976)

- Research is an honest, scientific investigation undertaken for discovering new facts or establishing new relationships among facts already known which will contribute to the present body of knowledge and can lead to an effective solution of existing problems.

- The process of collecting/gathering data and information by a scientific or logical procedure that aims to solve a particular scientific problem.

• What is not a Research?

Research is not only gathering information; such as gathering information from resources such as books and magazines. Research is not only the transportation of facts; only transporting facts from one resource to another doesn’t constitute research. 

Only gathering information, and merely transporting facts from one resource to another does not contribute to new knowledge although this might make existing knowledge more accessible.

• Characteristics of Research

The characteristics of the research are as follows:

- Originates with a question or problem

- Involves the gathering of new data from new sources or 1st hand information

- Directed towards the solution of a problem

- Characterized by carefully designed procedures applying rigorous analysis

- Emphasizes the development of generalizations, principles, hypothesis, and theories that may be helpful in predicting future occurrences

- Requires expertise

- Demands accurate observation and description of what is being studied

- Strives to be logical, applying every possible test to validate the procedures being employed

- Requires innovative approaches and determination to succeed

- Carefully and accurately recorded and reported

- Cyclical (helical) in nature.

• Purpose of Research

The purpose of research are as follows:

- Corrects perceptions

- Develops and evaluates concepts, practices, and theories

- Gathers information on a certain phenomenon that is lacking in knowledge

- Obtains knowledge for practical purposes

- Provides hard facts that serve as a basis for planning, decision-making, project implementation, monitoring, and evaluation.

- Finding answers to questions or solutions to problems

- Discovering and interpreting new facts

- Testing theories to revise accepted theories or laws in the light of new facts

- Formulating new theories.

• Importance of Research

According to Hudson Maxim “All progress is born of inquiry. Doubt is often better than overconfidence, for it leads to inquiry, and inquiry leads to invention”. Research is important because it contributes to new knowledge. Further explanation of the importance of research are highlighted as follows:

- Research inculcates scientific and inductive thinking and it promotes the development of logical habits of thinking and organization.

- New knowledge and facts are obtained through research which can lead to invention and innovation

- Solve operational problems; research, as an aid to economic policy, has gained added importance, both for government and business.

- Research provides the basis for nearly all government policies in our economic and health system.

- Perceptions and assumptions can be generalized or proved through research

- Appropriate decisions can be made through evidence generation via research

- Existing technologies are invented and upgraded through research which makes our daily life and work life easier

- Research is important to broaden our knowledge

- Research is equally important for social scientists in studying social relationships and in seeking answers to various social problems.

In addition to what has been stated above, the significance of research can also be understood keeping in view the following points:

1. To those students who are to write a master’s or Ph.D. thesis, research may mean a careerism or a way to attain a high position in the social structure;
2. To professionals in research methodology, research may mean a source of livelihood;
3. To philosophers and thinkers, research may mean the outlet for new ideas and insights;
4. To literary men and women, research may mean the development of new styles and creative work;
5. To analysts and intellectuals, research may mean the generalizations of new theories.

Thus, research is the fountain of knowledge for the sake of knowledge and an important source of providing guidelines for solving different business, governmental and social problems. It is a sort of formal training which enables one to understand the new developments in one’s field in a better way.

• WHAT ABOUT RESEARCH in Health Science???

Research in health science is a systematic study and assessment of 

- health problems or phenomenon; 

- finding ways to improve practice and patient care through creative studies; 

- initiating and evaluating change; and 

taking action to make new knowledge useful in health.

RESEARCH in health science includes the breadth and depth of the discipline of health science and the rehabilitative, therapeutic and preventive aspects of health science as well as the preparation of practitioners and personnel involved in the total health sphere.

• Importance of Research in Health Science

- Research is essential to find out preventive ways for better health of the people and find out better treatments for patients. 

- It plays an important role in discovering new treatments and making sure that we use existing treatments in the best possible ways. 

- Research can find answers to things that are unknown, filling gaps in knowledge and changing the way that healthcare professionals work. 

- Improve the quality of life for people living with illness

- Improve future healthcare.

• Who needs Research???

Research is for the: 

- PCL Level/Undergraduate students doing term papers

- Graduate students defending master thesis/doctoral dissertation

- Doctors/nurses

- Legislators needing information to formulate the right kinds of laws.

- Technical staff of government officials providing the baseline reports.

- Supervisors, managers, top executives in both public and private sectors engaged in planning, decision-making evaluation and even in dealing with human behaviors.

- Consultants

- NGOs

• Limitations of Research

- Result of faulty planning and implementation of the project

- The individual researcher; research is better in team

- The scope of knowledge or information available about the topic and the problem under study also must be considered

- The tools of measurement may be inadequate or entirely lacking.