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Study designs: Part 1 – An overview and classification

Priya ranganathan, rakesh aggarwal.

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Address for correspondence: Dr. Priya Ranganathan, Department of Anaesthesiology, Tata Memorial Centre, Ernest Borges Road, Parel, Mumbai - 400 012, Maharashtra, India. E-mail: [email protected]

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There are several types of research study designs, each with its inherent strengths and flaws. The study design used to answer a particular research question depends on the nature of the question and the availability of resources. In this article, which is the first part of a series on “study designs,” we provide an overview of research study designs and their classification. The subsequent articles will focus on individual designs.

Keywords: Epidemiologic methods, research design, research methodology

INTRODUCTION

Research study design is a framework, or the set of methods and procedures used to collect and analyze data on variables specified in a particular research problem.

Research study designs are of many types, each with its advantages and limitations. The type of study design used to answer a particular research question is determined by the nature of question, the goal of research, and the availability of resources. Since the design of a study can affect the validity of its results, it is important to understand the different types of study designs and their strengths and limitations.

There are some terms that are used frequently while classifying study designs which are described in the following sections.

A variable represents a measurable attribute that varies across study units, for example, individual participants in a study, or at times even when measured in an individual person over time. Some examples of variables include age, sex, weight, height, health status, alive/dead, diseased/healthy, annual income, smoking yes/no, and treated/untreated.

Exposure (or intervention) and outcome variables

A large proportion of research studies assess the relationship between two variables. Here, the question is whether one variable is associated with or responsible for change in the value of the other variable. Exposure (or intervention) refers to the risk factor whose effect is being studied. It is also referred to as the independent or the predictor variable. The outcome (or predicted or dependent) variable develops as a consequence of the exposure (or intervention). Typically, the term “exposure” is used when the “causative” variable is naturally determined (as in observational studies – examples include age, sex, smoking, and educational status), and the term “intervention” is preferred where the researcher assigns some or all participants to receive a particular treatment for the purpose of the study (experimental studies – e.g., administration of a drug). If a drug had been started in some individuals but not in the others, before the study started, this counts as exposure, and not as intervention – since the drug was not started specifically for the study.

Observational versus interventional (or experimental) studies

Observational studies are those where the researcher is documenting a naturally occurring relationship between the exposure and the outcome that he/she is studying. The researcher does not do any active intervention in any individual, and the exposure has already been decided naturally or by some other factor. For example, looking at the incidence of lung cancer in smokers versus nonsmokers, or comparing the antenatal dietary habits of mothers with normal and low-birth babies. In these studies, the investigator did not play any role in determining the smoking or dietary habit in individuals.

For an exposure to determine the outcome, it must precede the latter. Any variable that occurs simultaneously with or following the outcome cannot be causative, and hence is not considered as an “exposure.”

Observational studies can be either descriptive (nonanalytical) or analytical (inferential) – this is discussed later in this article.

Interventional studies are experiments where the researcher actively performs an intervention in some or all members of a group of participants. This intervention could take many forms – for example, administration of a drug or vaccine, performance of a diagnostic or therapeutic procedure, and introduction of an educational tool. For example, a study could randomly assign persons to receive aspirin or placebo for a specific duration and assess the effect on the risk of developing cerebrovascular events.

Descriptive versus analytical studies

Descriptive (or nonanalytical) studies, as the name suggests, merely try to describe the data on one or more characteristics of a group of individuals. These do not try to answer questions or establish relationships between variables. Examples of descriptive studies include case reports, case series, and cross-sectional surveys (please note that cross-sectional surveys may be analytical studies as well – this will be discussed in the next article in this series). Examples of descriptive studies include a survey of dietary habits among pregnant women or a case series of patients with an unusual reaction to a drug.

Analytical studies attempt to test a hypothesis and establish causal relationships between variables. In these studies, the researcher assesses the effect of an exposure (or intervention) on an outcome. As described earlier, analytical studies can be observational (if the exposure is naturally determined) or interventional (if the researcher actively administers the intervention).

Directionality of study designs

Based on the direction of inquiry, study designs may be classified as forward-direction or backward-direction. In forward-direction studies, the researcher starts with determining the exposure to a risk factor and then assesses whether the outcome occurs at a future time point. This design is known as a cohort study. For example, a researcher can follow a group of smokers and a group of nonsmokers to determine the incidence of lung cancer in each. In backward-direction studies, the researcher begins by determining whether the outcome is present (cases vs. noncases [also called controls]) and then traces the presence of prior exposure to a risk factor. These are known as case–control studies. For example, a researcher identifies a group of normal-weight babies and a group of low-birth weight babies and then asks the mothers about their dietary habits during the index pregnancy.

Prospective versus retrospective study designs

The terms “prospective” and “retrospective” refer to the timing of the research in relation to the development of the outcome. In retrospective studies, the outcome of interest has already occurred (or not occurred – e.g., in controls) in each individual by the time s/he is enrolled, and the data are collected either from records or by asking participants to recall exposures. There is no follow-up of participants. By contrast, in prospective studies, the outcome (and sometimes even the exposure or intervention) has not occurred when the study starts and participants are followed up over a period of time to determine the occurrence of outcomes. Typically, most cohort studies are prospective studies (though there may be retrospective cohorts), whereas case–control studies are retrospective studies. An interventional study has to be, by definition, a prospective study since the investigator determines the exposure for each study participant and then follows them to observe outcomes.

The terms “prospective” versus “retrospective” studies can be confusing. Let us think of an investigator who starts a case–control study. To him/her, the process of enrolling cases and controls over a period of several months appears prospective. Hence, the use of these terms is best avoided. Or, at the very least, one must be clear that the terms relate to work flow for each individual study participant, and not to the study as a whole.

Classification of study designs

Figure 1 depicts a simple classification of research study designs. The Centre for Evidence-based Medicine has put forward a useful three-point algorithm which can help determine the design of a research study from its methods section:[ 1 ]

Classification of research study designs

Does the study describe the characteristics of a sample or does it attempt to analyze (or draw inferences about) the relationship between two variables? – If no, then it is a descriptive study, and if yes, it is an analytical (inferential) study

If analytical, did the investigator determine the exposure? – If no, it is an observational study, and if yes, it is an experimental study

If observational, when was the outcome determined? – at the start of the study (case–control study), at the end of a period of follow-up (cohort study), or simultaneously (cross sectional).

In the next few pieces in the series, we will discuss various study designs in greater detail.

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1. Centre for Evidence-Based Medicine. Study Designs. 2016. [Last accessed on 2018 Sep 04]. Available from: https://www.cebm.net/2014/04/study-designs/
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Methodology

Research Design | Step-by-Step Guide with Examples

Published on 5 May 2022 by Shona McCombes . Revised on 20 March 2023.

A research design is a strategy for answering your research question using empirical data. Creating a research design means making decisions about:

Your overall aims and approach
The type of research design you’ll use
Your sampling methods or criteria for selecting subjects
Your data collection methods
The procedures you’ll follow to collect data
Your data analysis methods

A well-planned research design helps ensure that your methods match your research aims and that you use the right kind of analysis for your data.

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, frequently asked questions.

Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities – start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

How much time do you have to collect data and write up the research?
Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

Prevent plagiarism, run a free check.

Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types. Experimental and quasi-experimental designs allow you to test cause-and-effect relationships, while descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends, and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analysing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study – plants, animals, organisations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region, or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalise your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study, your aim is to deeply understand a specific context, not to generalise to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question.

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviours, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews.

Observation methods

Observations allow you to collect data unobtrusively, observing characteristics, behaviours, or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected – for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are reliable and valid.

Operationalisation

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalisation means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in – for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced , while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method, you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

How many participants do you need for an adequate sample size?
What inclusion and exclusion criteria will you use to identify eligible participants?
How will you contact your sample – by mail, online, by phone, or in person?

If you’re using a probability sampling method, it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method, how will you avoid bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organising and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymise and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well organised will save time when it comes to analysing them. It can also help other researchers validate and add to your findings.

On their own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyse the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarise your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarise your sample data in terms of:

The distribution of the data (e.g., the frequency of each score on a test)
The central tendency of the data (e.g., the mean to describe the average score)
The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

Make estimates about the population based on your sample data.
Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analysing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

A sample is a subset of individuals from a larger population. Sampling means selecting the group that you will actually collect data from in your research.

For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

Statistical sampling allows you to test a hypothesis about the characteristics of a population. There are various sampling methods you can use to ensure that your sample is representative of the population as a whole.

Operationalisation means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioural avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalise the variables that you want to measure.

The research methods you use depend on the type of data you need to answer your research question .

If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts, and meanings, use qualitative methods .
If you want to analyse a large amount of readily available data, use secondary data. If you want data specific to your purposes with control over how they are generated, collect primary data.
If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

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