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Research: Articulating Questions, Generating Hypotheses, and Choosing Study Designs

Mary p tully.

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Address correspondence to: Dr Mary P Tully, Manchester Pharmacy School, University of Manchester, Oxford Road, Manchester M13 9PT UK, e-mail: [email protected]

INTRODUCTION

Articulating a clear and concise research question is fundamental to conducting a robust and useful research study. Although “getting stuck into” the data collection is the exciting part of research, this preparation stage is crucial. Clear and concise research questions are needed for a number of reasons. Initially, they are needed to enable you to search the literature effectively. They will allow you to write clear aims and generate hypotheses. They will also ensure that you can select the most appropriate research design for your study.

This paper begins by describing the process of articulating clear and concise research questions, assuming that you have minimal experience. It then describes how to choose research questions that should be answered and how to generate study aims and hypotheses from your questions. Finally, it describes briefly how your question will help you to decide on the research design and methods best suited to answering it.

TURNING CURIOSITY INTO QUESTIONS

A research question has been described as “the uncertainty that the investigator wants to resolve by performing her study” 1 or “a logical statement that progresses from what is known or believed to be true to that which is unknown and requires validation”. 2 Developing your question usually starts with having some general ideas about the areas within which you want to do your research. These might flow from your clinical work, for example. You might be interested in finding ways to improve the pharmaceutical care of patients on your wards. Alternatively, you might be interested in identifying the best antihypertensive agent for a particular subgroup of patients. Lipowski 2 described in detail how work as a practising pharmacist can be used to great advantage to generate interesting research questions and hence useful research studies. Ideas could come from questioning received wisdom within your clinical area or the rationale behind quick fixes or workarounds, or from wanting to improve the quality, safety, or efficiency of working practice.

Alternatively, your ideas could come from searching the literature to answer a query from a colleague. Perhaps you could not find a published answer to the question you were asked, and so you want to conduct some research yourself. However, just searching the literature to generate questions is not to be recommended for novices—the volume of material can feel totally overwhelming.

Use a research notebook, where you regularly write ideas for research questions as you think of them during your clinical practice or after reading other research papers. It has been said that the best way to have a great idea is to have lots of ideas and then choose the best. The same would apply to research questions!

When you first identify your area of research interest, it is likely to be either too narrow or too broad. Narrow questions (such as “How is drug X prescribed for patients with condition Y in my hospital?”) are usually of limited interest to anyone other than the researcher. Broad questions (such as “How can pharmacists provide better patient care?”) must be broken down into smaller, more manageable questions. If you are interested in how pharmacists can provide better care, for example, you might start to narrow that topic down to how pharmacists can provide better care for one condition (such as affective disorders) for a particular subgroup of patients (such as teenagers). Then you could focus it even further by considering a specific disorder (depression) and a particular type of service that pharmacists could provide (improving patient adherence). At this stage, you could write your research question as, for example, “What role, if any, can pharmacists play in improving adherence to fluoxetine used for depression in teenagers?”

TYPES OF RESEARCH QUESTIONS

Being able to consider the type of research question that you have generated is particularly useful when deciding what research methods to use. There are 3 broad categories of question: descriptive, relational, and causal.

Descriptive

One of the most basic types of question is designed to ask systematically whether a phenomenon exists. For example, we could ask “Do pharmacists ‘care’ when they deliver pharmaceutical care?” This research would initially define the key terms (i.e., describing what “pharmaceutical care” and “care” are), and then the study would set out to look for the existence of care at the same time as pharmaceutical care was being delivered.

When you know that a phenomenon exists, you can then ask description and/or classification questions. The answers to these types of questions involve describing the characteristics of the phenomenon or creating typologies of variable subtypes. In the study above, for example, you could investigate the characteristics of the “care” that pharmacists provide. Classifications usually use mutually exclusive categories, so that various subtypes of the variable will have an unambiguous category to which they can be assigned. For example, a question could be asked as to “what is a pharmacist intervention” and a definition and classification system developed for use in further research.

When seeking further detail about your phenomenon, you might ask questions about its composition. These questions necessitate deconstructing a phenomenon (such as a behaviour) into its component parts. Within hospital pharmacy practice, you might be interested in asking questions about the composition of a new behavioural intervention to improve patient adherence, for example, “What is the detailed process that the pharmacist implicitly follows during delivery of this new intervention?”

After you have described your phenomena, you may then be interested in asking questions about the relationships between several phenomena. If you work on a renal ward, for example, you may be interested in looking at the relationship between hemoglobin levels and renal function, so your question would look something like this: “Are hemoglobin levels related to level of renal function?” Alternatively, you may have a categorical variable such as grade of doctor and be interested in the differences between them with regard to prescribing errors, so your research question would be “Do junior doctors make more prescribing errors than senior doctors?” Relational questions could also be asked within qualitative research, where a detailed understanding of the nature of the relationship between, for example, the gender and career aspirations of clinical pharmacists could be sought.

Once you have described your phenomena and have identified a relationship between them, you could ask about the causes of that relationship. You may be interested to know whether an intervention or some other activity has caused a change in your variable, and your research question would be about causality. For example, you may be interested in asking, “Does captopril treatment reduce blood pressure?” Generally, however, if you ask a causality question about a medication or any other health care intervention, it ought to be rephrased as a causality–comparative question. Without comparing what happens in the presence of an intervention with what happens in the absence of the intervention, it is impossible to attribute causality to the intervention. Although a causality question would usually be answered using a comparative research design, asking a causality–comparative question makes the research design much more explicit. So the above question could be rephrased as, “Is captopril better than placebo at reducing blood pressure?”

The acronym PICO has been used to describe the components of well-crafted causality–comparative research questions. 3 The letters in this acronym stand for Population, Intervention, Comparison, and Outcome. They remind the researcher that the research question should specify the type of participant to be recruited, the type of exposure involved, the type of control group with which participants are to be compared, and the type of outcome to be measured. Using the PICO approach, the above research question could be written as “Does captopril [ intervention ] decrease rates of cardiovascular events [ outcome ] in patients with essential hypertension [ population ] compared with patients receiving no treatment [ comparison ]?”

DECIDING WHETHER TO ANSWER A RESEARCH QUESTION

Just because a question can be asked does not mean that it needs to be answered. Not all research questions deserve to have time spent on them. One useful set of criteria is to ask whether your research question is feasible, interesting, novel, ethical, and relevant. 1 The need for research to be ethical will be covered in a later paper in the series, so is not discussed here. The literature review is crucial to finding out whether the research question fulfils the remaining 4 criteria.

Conducting a comprehensive literature review will allow you to find out what is already known about the subject and any gaps that need further exploration. You may find that your research question has already been answered. However, that does not mean that you should abandon the question altogether. It may be necessary to confirm those findings using an alternative method or to translate them to another setting. If your research question has no novelty, however, and is not interesting or relevant to your peers or potential funders, you are probably better finding an alternative.

The literature will also help you learn about the research designs and methods that have been used previously and hence to decide whether your potential study is feasible. As a novice researcher, it is particularly important to ask if your planned study is feasible for you to conduct. Do you or your collaborators have the necessary technical expertise? Do you have the other resources that will be needed? If you are just starting out with research, it is likely that you will have a limited budget, in terms of both time and money. Therefore, even if the question is novel, interesting, and relevant, it may not be one that is feasible for you to answer.

GENERATING AIMS AND HYPOTHESES

All research studies should have at least one research question, and they should also have at least one aim. As a rule of thumb, a small research study should not have more than 2 aims as an absolute maximum. The aim of the study is a broad statement of intention and aspiration; it is the overall goal that you intend to achieve. The wording of this broad statement of intent is derived from the research question. If it is a descriptive research question, the aim will be, for example, “to investigate” or “to explore”. If it is a relational research question, then the aim should state the phenomena being correlated, such as “to ascertain the impact of gender on career aspirations”. If it is a causal research question, then the aim should include the direction of the relationship being tested, such as “to investigate whether captopril decreases rates of cardiovascular events in patients with essential hypertension, relative to patients receiving no treatment”.

The hypothesis is a tentative prediction of the nature and direction of relationships between sets of data, phrased as a declarative statement. Therefore, hypotheses are really only required for studies that address relational or causal research questions. For the study above, the hypothesis being tested would be “Captopril decreases rates of cardiovascular events in patients with essential hypertension, relative to patients receiving no treatment”. Studies that seek to answer descriptive research questions do not test hypotheses, but they can be used for hypothesis generation. Those hypotheses would then be tested in subsequent studies.

CHOOSING THE STUDY DESIGN

The research question is paramount in deciding what research design and methods you are going to use. There are no inherently bad research designs. The rightness or wrongness of the decision about the research design is based simply on whether it is suitable for answering the research question that you have posed.

It is possible to select completely the wrong research design to answer a specific question. For example, you may want to answer one of the research questions outlined above: “Do pharmacists ‘care’ when they deliver pharmaceutical care?” Although a randomized controlled study is considered by many as a “gold standard” research design, such a study would just not be capable of generating data to answer the question posed. Similarly, if your question was, “Is captopril better than placebo at reducing blood pressure?”, conducting a series of in-depth qualitative interviews would be equally incapable of generating the necessary data. However, if these designs are swapped around, we have 2 combinations (pharmaceutical care investigated using interviews; captopril investigated using a randomized controlled study) that are more likely to produce robust answers to the questions.

The language of the research question can be helpful in deciding what research design and methods to use. Subsequent papers in this series will cover these topics in detail. For example, if the question starts with “how many” or “how often”, it is probably a descriptive question to assess the prevalence or incidence of a phenomenon. An epidemiological research design would be appropriate, perhaps using a postal survey or structured interviews to collect the data. If the question starts with “why” or “how”, then it is a descriptive question to gain an in-depth understanding of a phenomenon. A qualitative research design, using in-depth interviews or focus groups, would collect the data needed. Finally, the term “what is the impact of” suggests a causal question, which would require comparison of data collected with and without the intervention (i.e., a before–after or randomized controlled study).

CONCLUSIONS

This paper has briefly outlined how to articulate research questions, formulate your aims, and choose your research methods. It is crucial to realize that articulating a good research question involves considerable iteration through the stages described above. It is very common that the first research question generated bears little resemblance to the final question used in the study. The language is changed several times, for example, because the first question turned out not to be feasible and the second question was a descriptive question when what was really wanted was a causality question. The books listed in the “Further Reading” section provide greater detail on the material described here, as well as a wealth of other information to ensure that your first foray into conducting research is successful.

This article is the second in the CJHP Research Primer Series, an initiative of the CJHP Editorial Board and the CSHP Research Committee. The planned 2-year series is intended to appeal to relatively inexperienced researchers, with the goal of building research capacity among practising pharmacists. The articles, presenting simple but rigorous guidance to encourage and support novice researchers, are being solicited from authors with appropriate expertise.

Previous article in this series:

Bond CM. The research jigsaw: how to get started. Can J Hosp Pharm . 2014;67(1):28–30.

Competing interests: Mary Tully has received personal fees from the UK Renal Pharmacy Group to present a conference workshop on writing research questions and nonfinancial support (in the form of travel and accommodation) from the Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) to present a workshop on conducting pharmacy practice research.

  • 1. Hulley S, Cummings S, Browner W, Grady D, Newman T. Designing clinical research. 4th ed. Philadelphia (PA): Lippincott, Williams and Wilkins; 2013. [ Google Scholar ]
  • 2. Lipowski EE. Developing great research questions. Am J Health Syst Pharm. 2008;65(17):1667–70. doi: 10.2146/ajhp070276. [ DOI ] [ PubMed ] [ Google Scholar ]
  • 3. Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123(3):A12–3. [ PubMed ] [ Google Scholar ]

Further Reading

  • Cresswell J. Research design: qualitative, quantitative and mixed methods approaches. London (UK): Sage; 2009. [ Google Scholar ]
  • Haynes RB, Sackett DL, Guyatt GH, Tugwell P. Clinical epidemiology: how to do clinical practice research. 3rd ed. Philadelphia (PA): Lippincott, Williams & Wilkins; 2006. [ Google Scholar ]
  • Kumar R. Research methodology: a step-by-step guide for beginners. 3rd ed. London (UK): Sage; 2010. [ Google Scholar ]
  • Smith FJ. Conducting your pharmacy practice research project. London (UK): Pharmaceutical Press; 2005. [ Google Scholar ]
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How to choose your study design

Affiliation.

  • 1 Department of Medicine, Sydney Medical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
  • PMID: 32479703
  • DOI: 10.1111/jpc.14929

Research designs are broadly divided into observational studies (i.e. cross-sectional; case-control and cohort studies) and experimental studies (randomised control trials, RCTs). Each design has a specific role, and each has both advantages and disadvantages. Moreover, while the typical RCT is a parallel group design, there are now many variants to consider. It is important that both researchers and paediatricians are aware of the role of each study design, their respective pros and cons, and the inherent risk of bias with each design. While there are numerous quantitative study designs available to researchers, the final choice is dictated by two key factors. First, by the specific research question. That is, if the question is one of 'prevalence' (disease burden) then the ideal is a cross-sectional study; if it is a question of 'harm' - a case-control study; prognosis - a cohort and therapy - a RCT. Second, by what resources are available to you. This includes budget, time, feasibility re-patient numbers and research expertise. All these factors will severely limit the choice. While paediatricians would like to see more RCTs, these require a huge amount of resources, and in many situations will be unethical (e.g. potentially harmful intervention) or impractical (e.g. rare diseases). This paper gives a brief overview of the common study types, and for those embarking on such studies you will need far more comprehensive, detailed sources of information.

Keywords: experimental studies; observational studies; research method.

© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

""

Study designs are the set of methods and procedures used to collect and analyze data in a study.

Broadly speaking, there are 2 types of study designs: descriptive studies and analytical studies.

Descriptive studies

  • Describes specific characteristics in a population of interest
  • The most common forms are case reports and case series
  • In a case report, we discuss our experience with the patient’s symptoms, signs, diagnosis, and treatment
  • In a case series, several patients with similar experiences are grouped.

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

Observational studies are studies that we conduct without any intervention or experiment. In those studies, we purely observe the outcomes.  On the other hand, in experimental studies, we conduct experiments and interventions.

Observational studies

Observational studies include many subtypes. Below, I will discuss the most common designs.

Cross-sectional study:

  • This design is transverse where we take a specific sample at a specific time without any follow-up
  • It allows us to calculate the frequency of disease ( p revalence ) or the frequency of a risk factor
  • This design is easy to conduct
  • For example – if we want to know the prevalence of migraine in a population, we can conduct a cross-sectional study whereby we take a sample from the population and calculate the number of patients with migraine headaches.

Cohort study:

  • We conduct this study by comparing two samples from the population: one sample with a risk factor while the other lacks this risk factor
  • It shows us the risk of developing the disease in individuals with the risk factor compared to those without the risk factor ( RR = relative risk )
  • Prospective : we follow the individuals in the future to know who will develop the disease
  • Retrospective : we look to the past to know who developed the disease (e.g. using medical records)
  • This design is the strongest among the observational studies
  • For example – to find out the relative risk of developing chronic obstructive pulmonary disease (COPD) among smokers, we take a sample including smokers and non-smokers. Then, we calculate the number of individuals with COPD among both.

Case-Control Study:

  • We conduct this study by comparing 2 groups: one group with the disease (cases) and another group without the disease (controls)
  • This design is always retrospective
  •  We aim to find out the odds of having a risk factor or an exposure if an individual has a specific disease (Odds ratio)
  •  Relatively easy to conduct
  • For example – we want to study the odds of being a smoker among hypertensive patients compared to normotensive ones. To do so, we choose a group of patients diagnosed with hypertension and another group that serves as the control (normal blood pressure). Then we study their smoking history to find out if there is a correlation.

Experimental Studies

  • Also known as interventional studies
  • Can involve animals and humans
  • Pre-clinical trials involve animals
  • Clinical trials are experimental studies involving humans
  • In clinical trials, we study the effect of an intervention compared to another intervention or placebo. As an example, I have listed the four phases of a drug trial:

I:  We aim to assess the safety of the drug ( is it safe ? )

II: We aim to assess the efficacy of the drug ( does it work ? )

III: We want to know if this drug is better than the old treatment ( is it better ? )

IV: We follow-up to detect long-term side effects ( can it stay in the market ? )

  • In randomized controlled trials, one group of participants receives the control, while the other receives the tested drug/intervention. Those studies are the best way to evaluate the efficacy of a treatment.

Finally, the figure below will help you with your understanding of different types of study designs.

A visual diagram describing the following. Two types of epidemiological studies are descriptive and analytical. Types of descriptive studies are case reports, case series, descriptive surveys. Types of analytical studies are observational or experimental. Observational studies can be cross-sectional, case-control or cohort studies. Types of experimental studies can be lab trials or field trials.

References (pdf)

You may also be interested in the following blogs for further reading:

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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you are amazing one!! if I get you I’m working with you! I’m student from Ethiopian higher education. health sciences student

' src=

Very informative and easy understandable

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You are my kind of doctor. Do not lose sight of your objective.

' src=

Wow very erll explained and easy to understand

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I’m Khamisu Habibu community health officer student from Abubakar Tafawa Balewa university teaching hospital Bauchi, Nigeria, I really appreciate your write up and you have make it clear for the learner. thank you

' src=

well understood,thank you so much

' src=

Well understood…thanks

' src=

Simply explained. Thank You.

' src=

Thanks a lot for this nice informative article which help me to understand different study designs that I felt difficult before

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That’s lovely to hear, Mona, thank you for letting the author know how useful this was. If there are any other particular topics you think would be useful to you, and are not already on the website, please do let us know.

' src=

it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

' src=

Thanks for this information

Thanks so much for this information….I have clearly known the types of study design Thanks

That’s so good to hear, Mirembe, thank you for letting the author know.

' src=

Very helpful article!! U have simplified everything for easy understanding

' src=

I’m a health science major currently taking statistics for health care workers…this is a challenging class…thanks for the simified feedback.

That’s good to hear this has helped you. Hopefully you will find some of the other blogs useful too. If you see any topics that are missing from the website, please do let us know!

' src=

Hello. I liked your presentation, the fact that you ranked them clearly is very helpful to understand for people like me who is a novelist researcher. However, I was expecting to read much more about the Experimental studies. So please direct me if you already have or will one day. Thank you

Dear Ay. My sincere apologies for not responding to your comment sooner. You may find it useful to filter the blogs by the topic of ‘Study design and research methods’ – here is a link to that filter: https://s4be.cochrane.org/blog/topic/study-design/ This will cover more detail about experimental studies. Or have a look on our library page for further resources there – you’ll find that on the ‘Resources’ drop down from the home page.

However, if there are specific things you feel you would like to learn about experimental studies, that are missing from the website, it would be great if you could let me know too. Thank you, and best of luck. Emma

' src=

Great job Mr Hadi. I advise you to prepare and study for the Australian Medical Board Exams as soon as you finish your undergrad study in Lebanon. Good luck and hope we can meet sometime in the future. Regards ;)

' src=

You have give a good explaination of what am looking for. However, references am not sure of where to get them from.

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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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StatPearls [Internet].

Epidemiology of study design.

Swapna Munnangi ; Sameh W. Boktor .

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Last Update: April 24, 2023 .

  • Introduction

In epidemiology, researchers are interested in measuring or assessing the relationship of exposure with a disease or an outcome. As a first step, they define the hypothesis based on the research question and then decide which study design will be best suited to answer that question. How the researcher conducts the investigation is directed by the chosen study design. The study designs can be broadly classified as experimental or observational based on the approach used to assess whether exposure and an outcome are associated. In an experimental study design, researchers assign patients to intervention and control/comparison groups in an attempt to isolate the effects of the intervention. Being able to control various aspects of the experimental study design enables the researchers to identify causal links between interventions and outcomes of interest. In several instances, an experimental study design may not be feasible or suitable; observational studies are conducted in such situations. As the name indicates, observational studies involve merely observing the patients in a non-controlled environment without actually interfering or manipulating with other aspects of the study and therefore are non-experimental. The observation can be prospective, retrospective, or current, depending on the subtype of an observational study. [1]

Observational Studies

Case-Control Studies

Case-control studies are used to determine the degree of associations between various risk factors and outcomes. The factors that affect the risk of a disease are called exposures. Case-control studies can help identify beneficial or harmful exposures. As the name suggests, there are two groups of patient cases and controls in a case-control study. Cases are patients who have a particular disease, condition, or disability. Controls are those patients that do not have the disease. Typically, researchers identify appropriate representative controls for the cases that they are studying from the general population. Then they retrospectively look in the past for the possible exposures these patients might have had to a risk factor. Selecting the patients for the control group is a very critical component of research based on case-control studies. Due to the retrospective nature of the study design, case-control studies are subject to recall bias. Case-control studies are inexpensive, efficient, and often less time-consuming to conduct. This study design is especially suitable for rare diseases that have long latency periods. [2]

Case-Crossover Studies

Case-crossover studies are helpful to study triggers within an individual. When the researcher is studying a transient exposure or risk factor, the case-crossover design is useful. This is a relatively new study design where there is a case and a control component, both of which come from the same individual. Each case is self-matched by serving as its own control. Determining the control and case components period is a critical and difficult aspect of a case-crossover study. [3]

Cohort Studies

Cohort studies initially classify patients into two groups based on their exposure status. Cohorts are followed over time to see who develops the disease in the exposed and non-exposed groups. Cohort studies can be retrospective or prospective. Incidence can be directly calculated from a cohort study as you begin with exposed and unexposed patients, unlike a case-control study where you start with diseased and non-diseased patients. Relative risk is the measure of effect for a cohort study. Cohort studies are subject to very low recall bias, and multiple outcomes can be studied simultaneously. One of the disadvantages of cohort studies is that they are more prone to selection bias. Studying rare diseases and outcomes that have long follow-up periods can be very expensive and time-consuming using cohort studies. [4]

Cross-Sectional Studies

Cross-sectional studies are observational in nature and give a snapshot of the characteristics of study subjects in a single point of time. Unlike cohort studies, cross-sectional studies do not have a follow-up period and therefore are relatively simple to conduct. As the exposure status/outcome of interest information is collected in a single moment in time, often by surveys, cross-sectional study design cannot provide a cause-effect relationship and is the weakest of the observational designs. This study design is generally used to assess the prevalence of a disease in a population. [5]

Ecological Studies

Ecological studies are used when data at an individual level is unavailable, or large-scale comparisons are needed to study the population-level effect of exposures on a disease condition. Therefore, ecological study results are applicable only at the population level. The types of measures in ecological studies are aggregates of individual-level data. These studies, therefore, are subject to a type of confounding called an ecological fallacy, which occurs when relationships identified at group level data are assumed to be true for individuals. Ecological studies are generally used in public health research. [6]

Experimental Studies

Randomized Clinical Trials

Randomized clinical trials or randomized control trials (RCT) are considered the gold standard of study design. In an RCT, the researcher randomly assigns the subjects to a control group and an experimental group. Randomization in RCT avoids confounding and minimizes selection bias. This enables the researcher to have similar experimental and control groups, thereby enabling them to isolate the effect of an intervention. The experimental group gets the exposure/treatment, which can be an agent involved in causation, prevention, or treatment of a disease. The control group receives no treatment, a placebo treatment, or another standard of care treatment depending on the study's objective. The groups are then followed prospectively to see who develops the outcome of interest. RCT’s are expensive, and researchers using this study design often face issues with the integrity of randomization due to refusals, drops outs, crossovers, and non-compliance. [7] [8]

The key function of an epidemiology study design is to enable the researcher to address the research question with minimal ambiguity logically.

  • Issues of Concern

Study design should be well thought of before initiating a research investigation. Choosing an inappropriate study design may undermine overall study validity. Critical thinking about the possible study design issues beforehand will ensure that the research question is adequately addressed.

  • Clinical Significance

Study design plays a major role in determining the scientific value of a research study. Understanding the basic study design concepts will aid the clinicians in practicing evidence-based medicine. [9]

  • Other Issues

Errors in study design are extremely difficult to correct after study completion. Thorough planning is required to avoid weak conclusions or unconvincing results.

  • Enhancing Healthcare Team Outcomes

All interprofessional healthcare team members, including clinicians, mid-level practitioners, nurses, pharmacists, and therapists, need to be well-versed in the various study designs utilized to perform medical research. Such knowledge can help delineate strong studies and results from weaker ones, determine the clinical applicability of study results, and enhance patient care through the appropriate application of data-driven research results. Failure to understand study design and the strength of data provided by various types of studies can lead to improper decision-making and negatively impact patient outcomes. [10] [Level 5]

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Disclosure: Swapna Munnangi declares no relevant financial relationships with ineligible companies.

Disclosure: Sameh Boktor declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

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  • Published: 21 October 2024

How to design and conduct a megastudy

  • Jan G. Voelkel 1 ,
  • James Y. Chu   ORCID: orcid.org/0000-0003-2702-470X 2 ,
  • Michael N. Stagnaro   ORCID: orcid.org/0000-0001-5512-7218 3 ,
  • James N. Druckman   ORCID: orcid.org/0000-0002-1249-6790 4 &
  • Robb Willer   ORCID: orcid.org/0000-0003-3404-6472 5  

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Megastudies are experiments that test many treatments simultaneously using the same outcomes, control condition and sample, and are a promising tool that can provide unique insights relative to other research designs. We identify five critical decisions in designing megastudies and suggest potential solutions for each.

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J.G.V. received funding from a Stanford Interdisciplinary Graduate Fellowship. M.N.S. received funding from the United States Department of the Navy Office of Naval Research. R.W. received funding from the Stanford Center on Philanthropy and Civil Society.

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Voelkel, J.G., Chu, J.Y., Stagnaro, M.N. et al. How to design and conduct a megastudy. Nat Hum Behav (2024). https://doi.org/10.1038/s41562-024-01998-2

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Nuffield Department of Primary Care Health Sciences, University of Oxford

Study designs

This short article gives a brief guide to the different study types and a comparison of the advantages and disadvantages.

See also  Levels of Evidence  

These study designs all have similar components (as we’d expect from the PICO):

  • A defined population (P) from which groups of subjects are studied
  • Outcomes (O) that are measured

And for experimental and analytic observational studies:

  • Interventions (I) or exposures (E) that are applied to different groups of subjects

Overview of the design tree

Figure 1 shows the tree of possible designs, branching into subgroups of study designs by whether the studies are descriptive or analytic and by whether the analytic studies are experimental or observational. The list is not completely exhaustive but covers most basics designs.

Flow-chart depicting study design

Figure: Tree of different types of studies (Q1, 2, and 3 refer to the three questions below)

> Download a PDF by Jeremy Howick about study designs

Our first distinction is whether the study is analytic or non-analytic. A  non-analytic  or  descriptive  study does not try to quantify the relationship but tries to give us a picture of what is happening in a population, e.g., the prevalence, incidence, or experience of a group. Descriptive studies include case reports, case-series, qualitative studies and surveys (cross-sectional) studies, which measure the frequency of several factors, and hence the size of the problem. They may sometimes also include analytic work (comparing factors “” see below).

An  analytic  study attempts to quantify the relationship between two factors, that is, the effect of an intervention (I) or exposure (E) on an outcome (O). To quantify the effect we will need to know the rate of outcomes in a comparison (C) group as well as the intervention or exposed group. Whether the researcher actively changes a factor or imposes uses an intervention determines whether the study is considered to be observational (passive involvement of researcher), or experimental (active involvement of researcher).

In  experimental  studies, the researcher manipulates the exposure, that is he or she allocates subjects to the intervention or exposure group. Experimental studies, or randomised controlled trials (RCTs), are similar to experiments in other areas of science. That is, subjects are allocated to two or more groups to receive an intervention or exposure and then followed up under carefully controlled conditions. Such studies controlled trials, particularly if randomised and blinded, have the potential to control for most of the biases that can occur in scientific studies but whether this actually occurs depends on the quality of the study design and implementation.

In  analytic observational  studies, the researcher simply measures the exposure or treatments of the groups. Analytical observational studies include case””control studies, cohort studies and some population (cross-sectional) studies. These studies all include matched groups of subjects and assess of associations between exposures and outcomes.

Observational studies investigate and record exposures (such as interventions or risk factors) and observe outcomes (such as disease) as they occur. Such studies may be purely descriptive or more analytical.

We should finally note that studies can incorporate several design elements. For example, a the control arm of a randomised trial may also be used as a cohort study; and the baseline measures of a cohort study may be used as a cross-sectional study.

Spotting the study design

The type of study can generally be worked at by looking at three issues (as per the Tree of design in Figure 1):

Q1. What was the aim of the study?

  • To simply describe a population (PO questions) descriptive
  • To quantify the relationship between factors (PICO questions) analytic.

Q2. If analytic, was the intervention randomly allocated?

  • No? Observational study

For observational study the main types will then depend on the timing of the measurement of outcome, so our third question is:

Q3. When were the outcomes determined?

  • Some time after the exposure or intervention? cohort study (‘prospective study’)
  • At the same time as the exposure or intervention? cross sectional study or survey
  • Before the exposure was determined? case-control study (‘retrospective study’ based on recall of the exposure)

Advantages and Disadvantages of the Designs

Randomised Controlled Trial

An experimental comparison study in which participants are allocated to treatment/intervention or control/placebo groups using a random mechanism (see randomisation). Best for study the effect of an intervention.

Advantages:

  • unbiased distribution of confounders;
  • blinding more likely;
  • randomisation facilitates statistical analysis.

Disadvantages:

  • expensive: time and money;
  • volunteer bias;
  • ethically problematic at times.

Crossover Design

A controlled trial where each study participant has both therapies, e.g, is randomised to treatment A first, at the crossover point they then start treatment B. Only relevant if the outcome is reversible with time, e.g, symptoms.

  • all subjects serve as own controls and error variance is reduced thus reducing sample size needed;
  • all subjects receive treatment (at least some of the time);
  • statistical tests assuming randomisation can be used;
  • blinding can be maintained.
  • all subjects receive placebo or alternative treatment at some point;
  • washout period lengthy or unknown;
  • cannot be used for treatments with permanent effects

Cohort Study

Data are obtained from groups who have been exposed, or not exposed, to the new technology or factor of interest (eg from databases). No allocation of exposure is made by the researcher. Best for study the effect of predictive risk factors on an outcome.

  • ethically safe;
  • subjects can be matched;
  • can establish timing and directionality of events;
  • eligibility criteria and outcome assessments can be standardised;
  • administratively easier and cheaper than RCT.
  • controls may be difficult to identify;
  • exposure may be linked to a hidden confounder;
  • blinding is difficult;
  • randomisation not present;
  • for rare disease, large sample sizes or long follow-up necessary.

Case-Control Studies

Patients with a certain outcome or disease and an appropriate group of controls without the outcome or disease are selected (usually with careful consideration of appropriate choice of controls, matching, etc) and then information is obtained on whether the subjects have been exposed to the factor under investigation.

  • quick and cheap;
  • only feasible method for very rare disorders or those with long lag between exposure and outcome;
  • fewer subjects needed than cross-sectional studies.
  • reliance on recall or records to determine exposure status;
  • confounders;
  • selection of control groups is difficult;
  • potential bias: recall, selection.

Cross-Sectional Survey

A study that examines the relationship between diseases (or other health-related characteristics) and other variables of interest as they exist in a defined population at one particular time (ie exposure and outcomes are both measured at the same time). Best for quantifying the prevalence of a disease or risk factor, and for quantifying the accuracy of a diagnostic test.

  • cheap and simple;
  • ethically safe.
  • establishes association at most, not causality;
  • recall bias susceptibility;
  • confounders may be unequally distributed;
  • Neyman bias;
  • group sizes may be unequal.

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Literature Reviews: Types of Clinical Study Designs

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Types of Study Designs

Meta-Analysis A way of combining data from many different research studies. A meta-analysis is a statistical process that combines the findings from individual studies.  Example :  Anxiety outcomes after physical activity interventions: meta-analysis findings .  Conn V.  Nurs Res . 2010 May-Jun;59(3):224-31.

Systematic Review A summary of the clinical literature. A systematic review is a critical assessment and evaluation of all research studies that address a particular clinical issue. The researchers use an organized method of locating, assembling, and evaluating a body of literature on a particular topic using a set of specific criteria. A systematic review typically includes a description of the findings of the collection of research studies. The systematic review may also include a quantitative pooling of data, called a meta-analysis.  Example :  Complementary and alternative medicine use among women with breast cancer: a systematic review.   Wanchai A, Armer JM, Stewart BR. Clin J Oncol Nurs . 2010 Aug;14(4):E45-55.

Randomized Controlled Trial A controlled clinical trial that randomly (by chance) assigns participants to two or more groups. There are various methods to randomize study participants to their groups.  Example :  Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial .  Barrett B, et al.  Ann Fam Med . 2012 Jul-Aug;10(4):337-46.

Cohort Study (Prospective Observational Study) A clinical research study in which people who presently have a certain condition or receive a particular treatment are followed over time and compared with another group of people who are not affected by the condition.  Example : Smokeless tobacco cessation in South Asian communities: a multi-centre prospective cohort study . Croucher R, et al. Addiction. 2012 Dec;107 Suppl 2:45-52.

Case-control Study Case-control studies begin with the outcomes and do not follow people over time. Researchers choose people with a particular result (the cases) and interview the groups or check their records to ascertain what different experiences they had. They compare the odds of having an experience with the outcome to the odds of having an experience without the outcome.  Example :  Non-use of bicycle helmets and risk of fatal head injury: a proportional mortality, case-control study .  Persaud N, et al.  CMAJ . 2012 Nov 20;184(17):E921-3.

Cross-sectional study The observation of a defined population at a single point in time or time interval. Exposure and outcome are determined simultaneously.  Example :  Fasting might not be necessary before lipid screening: a nationally representative cross-sectional study .  Steiner MJ, et al.  Pediatrics . 2011 Sep;128(3):463-70.

Case Reports and Series A report on a series of patients with an outcome of interest. No control group is involved.  Example :  Students mentoring students in a service-learning clinical supervision experience: an educational case report .  Lattanzi JB, et al.  Phys Ther . 2011 Oct;91(10):1513-24.

Ideas, Editorials, Opinions Put forth by experts in the field.  Example : Health and health care for the 21st century: for all the people . Koop CE.  Am J Public Health . 2006 Dec;96(12):2090-2.

Animal Research Studies Studies conducted using animal subjects.  Example : Intranasal leptin reduces appetite and induces weight loss in rats with diet-induced obesity (DIO) .  Schulz C, Paulus K, Jöhren O, Lehnert H.   Endocrinology . 2012 Jan;153(1):143-53.

Test-tube Lab Research "Test tube" experiments conducted in a controlled laboratory setting.

Adapted from Study Designs. In NICHSR Introduction to Health Services Research: a Self-Study Course.  http://www.nlm.nih.gov/nichsr/ihcm/06studies/studies03.html and Glossary of EBM Terms. http://www.cebm.utoronto.ca/glossary/index.htm#top  

Study Design Terminology

Bias - Any deviation of results or inferences from the truth, or processes leading to such deviation. Bias can result from several sources: one-sided or systematic variations in measurement from the true value (systematic error); flaws in study design; deviation of inferences, interpretations, or analyses based on flawed data or data collection; etc. There is no sense of prejudice or subjectivity implied in the assessment of bias under these conditions.

Case Control Studies - Studies which start with the identification of persons with a disease of interest and a control (comparison, referent) group without the disease. The relationship of an attribute to the disease is examined by comparing diseased and non-diseased persons with regard to the frequency or levels of the attribute in each group.

Causality - The relating of causes to the effects they produce. Causes are termed necessary when they must always precede an effect and sufficient when they initiate or produce an effect. Any of several factors may be associated with the potential disease causation or outcome, including predisposing factors, enabling factors, precipitating factors, reinforcing factors, and risk factors.

Control Groups - Groups that serve as a standard for comparison in experimental studies. They are similar in relevant characteristics to the experimental group but do not receive the experimental intervention.

Controlled Clinical Trials - Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as Randomized Controlled Trials.

Cost-Benefit Analysis - A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. Cost effectiveness compares alternative ways to achieve a specific set of results.

Cross-Over Studies - Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given.

Cross-Sectional Studies - Studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time. This contrasts with LONGITUDINAL STUDIES which are followed over a period of time.

Double-Blind Method - A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.

Empirical Research - The study, based on direct observation, use of statistical records, interviews, or experimental methods, of actual practices or the actual impact of practices or policies.

Evaluation Studies - Works consisting of studies determining the effectiveness or utility of processes, personnel, and equipment.

Genome-Wide Association Study - An analysis comparing the allele frequencies of all available (or a whole genome representative set of) polymorphic markers in unrelated patients with a specific symptom or disease condition, and those of healthy controls to identify markers associated with a specific disease or condition.

Intention to Treat Analysis - Strategy for the analysis of Randomized Controlled Trial that compares patients in the groups to which they were originally randomly assigned.

Logistic Models - Statistical models which describe the relationship between a qualitative dependent variable (that is, one which can take only certain discrete values, such as the presence or absence of a disease) and an independent variable. A common application is in epidemiology for estimating an individual's risk (probability of a disease) as a function of a given risk factor.

Longitudinal Studies - Studies in which variables relating to an individual or group of individuals are assessed over a period of time.

Lost to Follow-Up - Study subjects in cohort studies whose outcomes are unknown e.g., because they could not or did not wish to attend follow-up visits.

Matched-Pair Analysis - A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Meta-Analysis - Works consisting of studies using a quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc. It is often an overview of clinical trials. It is usually called a meta-analysis by the author or sponsoring body and should be differentiated from reviews of literature.

Numbers Needed To Treat - Number of patients who need to be treated in order to prevent one additional bad outcome. It is the inverse of Absolute Risk Reduction.

Odds Ratio - The ratio of two odds. The exposure-odds ratio for case control data is the ratio of the odds in favor of exposure among cases to the odds in favor of exposure among noncases. The disease-odds ratio for a cohort or cross section is the ratio of the odds in favor of disease among the exposed to the odds in favor of disease among the unexposed. The prevalence-odds ratio refers to an odds ratio derived cross-sectionally from studies of prevalent cases.

Patient Selection - Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.

Predictive Value of Tests - In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test.

Prospective Studies - Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.

Qualitative Studies - Research that derives data from observation, interviews, or verbal interactions and focuses on the meanings and interpretations of the participants.

Quantitative Studies - Quantitative research is research that uses numerical analysis.

Random Allocation - A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.

Randomized Controlled Trial - Clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.

Reproducibility of Results - The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.

Retrospective Studies - Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons.

Sample Size - The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups.

Sensitivity and Specificity - Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition.

Single-Blind Method - A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.

Time Factors - Elements of limited time intervals, contributing to particular results or situations.

Source:  NLM MeSH Database

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What is research design? Types, elements, and examples

What is Research Design? Understand Types of Research Design, with Examples

Have you been wondering “ what is research design ?” or “what are some research design examples ?” Are you unsure about the research design elements or which of the different types of research design best suit your study? Don’t worry! In this article, we’ve got you covered!   

Table of Contents

What is research design?  

Have you been wondering “ what is research design ?” or “what are some research design examples ?” Don’t worry! In this article, we’ve got you covered!  

A research design is the plan or framework used to conduct a research study. It involves outlining the overall approach and methods that will be used to collect and analyze data in order to answer research questions or test hypotheses. A well-designed research study should have a clear and well-defined research question, a detailed plan for collecting data, and a method for analyzing and interpreting the results. A well-thought-out research design addresses all these features.  

Research design elements  

Research design elements include the following:  

  • Clear purpose: The research question or hypothesis must be clearly defined and focused.  
  • Sampling: This includes decisions about sample size, sampling method, and criteria for inclusion or exclusion. The approach varies for different research design types .  
  • Data collection: This research design element involves the process of gathering data or information from the study participants or sources. It includes decisions about what data to collect, how to collect it, and the tools or instruments that will be used.  
  • Data analysis: All research design types require analysis and interpretation of the data collected. This research design element includes decisions about the statistical tests or methods that will be used to analyze the data, as well as any potential confounding variables or biases that may need to be addressed.  
  • Type of research methodology: This includes decisions about the overall approach for the study.  
  • Time frame: An important research design element is the time frame, which includes decisions about the duration of the study, the timeline for data collection and analysis, and follow-up periods.  
  • Ethical considerations: The research design must include decisions about ethical considerations such as informed consent, confidentiality, and participant protection.  
  • Resources: A good research design takes into account decisions about the budget, staffing, and other resources needed to carry out the study.  

The elements of research design should be carefully planned and executed to ensure the validity and reliability of the study findings. Let’s go deeper into the concepts of research design .    

study design research article

Characteristics of research design  

Some basic characteristics of research design are common to different research design types . These characteristics of research design are as follows:  

  • Neutrality : Right from the study assumptions to setting up the study, a neutral stance must be maintained, free of pre-conceived notions. The researcher’s expectations or beliefs should not color the findings or interpretation of the findings. Accordingly, a good research design should address potential sources of bias and confounding factors to be able to yield unbiased and neutral results.   
  •   Reliability : Reliability is one of the characteristics of research design that refers to consistency in measurement over repeated measures and fewer random errors. A reliable research design must allow for results to be consistent, with few errors due to chance.   
  •   Validity : Validity refers to the minimization of nonrandom (systematic) errors. A good research design must employ measurement tools that ensure validity of the results.  
  •   Generalizability: The outcome of the research design should be applicable to a larger population and not just a small sample . A generalized method means the study can be conducted on any part of a population with similar accuracy.   
  •   Flexibility: A research design should allow for changes to be made to the research plan as needed, based on the data collected and the outcomes of the study  

A well-planned research design is critical for conducting a scientifically rigorous study that will generate neutral, reliable, valid, and generalizable results. At the same time, it should allow some level of flexibility.  

Different types of research design  

A research design is essential to systematically investigate, understand, and interpret phenomena of interest. Let’s look at different types of research design and research design examples .  

Broadly, research design types can be divided into qualitative and quantitative research.  

Qualitative research is subjective and exploratory. It determines relationships between collected data and observations. It is usually carried out through interviews with open-ended questions, observations that are described in words, etc.  

Quantitative research is objective and employs statistical approaches. It establishes the cause-and-effect relationship among variables using different statistical and computational methods. This type of research is usually done using surveys and experiments.  

Qualitative research vs. Quantitative research  

Qualitative research design types and qualitative research design examples  .

The following will familiarize you with the research design categories in qualitative research:  

  • Grounded theory: This design is used to investigate research questions that have not previously been studied in depth. Also referred to as exploratory design , it creates sequential guidelines, offers strategies for inquiry, and makes data collection and analysis more efficient in qualitative research.   

Example: A researcher wants to study how people adopt a certain app. The researcher collects data through interviews and then analyzes the data to look for patterns. These patterns are used to develop a theory about how people adopt that app.  

  •   Thematic analysis: This design is used to compare the data collected in past research to find similar themes in qualitative research.  

Example: A researcher examines an interview transcript to identify common themes, say, topics or patterns emerging repeatedly.  

  • Discourse analysis : This research design deals with language or social contexts used in data gathering in qualitative research.   

Example: Identifying ideological frameworks and viewpoints of writers of a series of policies.  

Quantitative research design types and quantitative research design examples  

Note the following research design categories in quantitative research:  

  • Descriptive research design : This quantitative research design is applied where the aim is to identify characteristics, frequencies, trends, and categories. It may not often begin with a hypothesis. The basis of this research type is a description of an identified variable. This research design type describes the “what,” “when,” “where,” or “how” of phenomena (but not the “why”).   

Example: A study on the different income levels of people who use nutritional supplements regularly.  

  • Correlational research design : Correlation reflects the strength and/or direction of the relationship among variables. The direction of a correlation can be positive or negative. Correlational research design helps researchers establish a relationship between two variables without the researcher controlling any of them.  

Example : An example of correlational research design could be studying the correlation between time spent watching crime shows and aggressive behavior in teenagers.  

  •   Diagnostic research design : In diagnostic design, the researcher aims to understand the underlying cause of a specific topic or phenomenon (usually an area of improvement) and find the most effective solution. In simpler terms, a researcher seeks an accurate “diagnosis” of a problem and identifies a solution.  

Example : A researcher analyzing customer feedback and reviews to identify areas where an app can be improved.    

  • Explanatory research design : In explanatory research design , a researcher uses their ideas and thoughts on a topic to explore their theories in more depth. This design is used to explore a phenomenon when limited information is available. It can help increase current understanding of unexplored aspects of a subject. It is thus a kind of “starting point” for future research.  

Example : Formulating hypotheses to guide future studies on delaying school start times for better mental health in teenagers.  

  •   Causal research design : This can be considered a type of explanatory research. Causal research design seeks to define a cause and effect in its data. The researcher does not use a randomly chosen control group but naturally or pre-existing groupings. Importantly, the researcher does not manipulate the independent variable.   

Example : Comparing school dropout levels and possible bullying events.  

  •   Experimental research design : This research design is used to study causal relationships . One or more independent variables are manipulated, and their effect on one or more dependent variables is measured.  

Example: Determining the efficacy of a new vaccine plan for influenza.  

Benefits of research design  

 T here are numerous benefits of research design . These are as follows:  

  • Clear direction: Among the benefits of research design , the main one is providing direction to the research and guiding the choice of clear objectives, which help the researcher to focus on the specific research questions or hypotheses they want to investigate.  
  • Control: Through a proper research design , researchers can control variables, identify potential confounding factors, and use randomization to minimize bias and increase the reliability of their findings.
  • Replication: Research designs provide the opportunity for replication. This helps to confirm the findings of a study and ensures that the results are not due to chance or other factors. Thus, a well-chosen research design also eliminates bias and errors.  
  • Validity: A research design ensures the validity of the research, i.e., whether the results truly reflect the phenomenon being investigated.  
  • Reliability: Benefits of research design also include reducing inaccuracies and ensuring the reliability of the research (i.e., consistency of the research results over time, across different samples, and under different conditions).  
  • Efficiency: A strong research design helps increase the efficiency of the research process. Researchers can use a variety of designs to investigate their research questions, choose the most appropriate research design for their study, and use statistical analysis to make the most of their data. By effectively describing the data necessary for an adequate test of the hypotheses and explaining how such data will be obtained, research design saves a researcher’s time.   

Overall, an appropriately chosen and executed research design helps researchers to conduct high-quality research, draw meaningful conclusions, and contribute to the advancement of knowledge in their field.

study design research article

Frequently Asked Questions (FAQ) on Research Design

Q: What are th e main types of research design?

Broadly speaking there are two basic types of research design –

qualitative and quantitative research. Qualitative research is subjective and exploratory; it determines relationships between collected data and observations. It is usually carried out through interviews with open-ended questions, observations that are described in words, etc. Quantitative research , on the other hand, is more objective and employs statistical approaches. It establishes the cause-and-effect relationship among variables using different statistical and computational methods. This type of research design is usually done using surveys and experiments.

Q: How do I choose the appropriate research design for my study?

Choosing the appropriate research design for your study requires careful consideration of various factors. Start by clarifying your research objectives and the type of data you need to collect. Determine whether your study is exploratory, descriptive, or experimental in nature. Consider the availability of resources, time constraints, and the feasibility of implementing the different research designs. Review existing literature to identify similar studies and their research designs, which can serve as a guide. Ultimately, the chosen research design should align with your research questions, provide the necessary data to answer them, and be feasible given your own specific requirements/constraints.

Q: Can research design be modified during the course of a study?

Yes, research design can be modified during the course of a study based on emerging insights, practical constraints, or unforeseen circumstances. Research is an iterative process and, as new data is collected and analyzed, it may become necessary to adjust or refine the research design. However, any modifications should be made judiciously and with careful consideration of their impact on the study’s integrity and validity. It is advisable to document any changes made to the research design, along with a clear rationale for the modifications, in order to maintain transparency and allow for proper interpretation of the results.

Q: How can I ensure the validity and reliability of my research design?

Validity refers to the accuracy and meaningfulness of your study’s findings, while reliability relates to the consistency and stability of the measurements or observations. To enhance validity, carefully define your research variables, use established measurement scales or protocols, and collect data through appropriate methods. Consider conducting a pilot study to identify and address any potential issues before full implementation. To enhance reliability, use standardized procedures, conduct inter-rater or test-retest reliability checks, and employ appropriate statistical techniques for data analysis. It is also essential to document and report your methodology clearly, allowing for replication and scrutiny by other researchers.

Editage All Access is a subscription-based platform that unifies the best AI tools and services designed to speed up, simplify, and streamline every step of a researcher’s journey. The Editage All Access Pack is a one-of-a-kind subscription that unlocks full access to an AI writing assistant, literature recommender, journal finder, scientific illustration tool, and exclusive discounts on professional publication services from Editage.  

Based on 22+ years of experience in academia, Editage All Access empowers researchers to put their best research forward and move closer to success. Explore our top AI Tools pack, AI Tools + Publication Services pack, or Build Your Own Plan. Find everything a researcher needs to succeed, all in one place –  Get All Access now starting at just $14 a month !    

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Market Research: A How-To Guide and Template

Discover the different types of market research, how to conduct your own market research, and use a free template to help you along the way.

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MARKET RESEARCH KIT

5 Research and Planning Templates + a Free Guide on How to Use Them in Your Market Research

buyers-journey-guide_3

Updated: 02/21/24

Published: 03/30/16

Today's consumers have a lot of power. As a business, you must have a deep understanding of who your buyers are and what influences their purchase decisions.

Enter: Market Research.

→ Download Now: Market Research Templates [Free Kit]

Whether you're new to market research or not, I created this guide to help you conduct a thorough study of your market, target audience, competition, and more. Let’s dive in.

Table of Contents

What is market research?

Primary vs. secondary research, types of market research, how to do market research, market research report template, market research examples.

Market research is the process of gathering information about your target market and customers to verify the success of a new product, help your team iterate on an existing product, or understand brand perception to ensure your team is effectively communicating your company's value effectively.

Market research can answer various questions about the state of an industry. But if you ask me, it's hardly a crystal ball that marketers can rely on for insights on their customers.

Market researchers investigate several areas of the market, and it can take weeks or even months to paint an accurate picture of the business landscape.

However, researching just one of those areas can make you more intuitive to who your buyers are and how to deliver value that no other business is offering them right now.

How? Consider these two things:

  • Your competitors also have experienced individuals in the industry and a customer base. It‘s very possible that your immediate resources are, in many ways, equal to those of your competition’s immediate resources. Seeking a larger sample size for answers can provide a better edge.
  • Your customers don't represent the attitudes of an entire market. They represent the attitudes of the part of the market that is already drawn to your brand.

The market research services market is growing rapidly, which signifies a strong interest in market research as we enter 2024. The market is expected to grow from roughly $75 billion in 2021 to $90.79 billion in 2025 .

study design research article

Free Market Research Kit

  • SWOT Analysis Template
  • Survey Template
  • Focus Group Template

Download Free

All fields are required.

You're all set!

Click this link to access this resource at any time.

Why do market research?

Market research allows you to meet your buyer where they are.

As our world becomes louder and demands more of our attention, this proves invaluable.

By understanding your buyer's problems, pain points, and desired solutions, you can aptly craft your product or service to naturally appeal to them.

Market research also provides insight into the following:

  • Where your target audience and current customers conduct their product or service research
  • Which of your competitors your target audience looks to for information, options, or purchases
  • What's trending in your industry and in the eyes of your buyer
  • Who makes up your market and what their challenges are
  • What influences purchases and conversions among your target audience
  • Consumer attitudes about a particular topic, pain, product, or brand
  • Whether there‘s demand for the business initiatives you’re investing in
  • Unaddressed or underserved customer needs that can be flipped into selling opportunity
  • Attitudes about pricing for a particular product or service

Ultimately, market research allows you to get information from a larger sample size of your target audience, eliminating bias and assumptions so that you can get to the heart of consumer attitudes.

As a result, you can make better business decisions.

To give you an idea of how extensive market research can get , consider that it can either be qualitative or quantitative in nature — depending on the studies you conduct and what you're trying to learn about your industry.

Qualitative research is concerned with public opinion, and explores how the market feels about the products currently available in that market.

Quantitative research is concerned with data, and looks for relevant trends in the information that's gathered from public records.

That said, there are two main types of market research that your business can conduct to collect actionable information on your products: primary research and secondary research.

Primary Research

Primary research is the pursuit of first-hand information about your market and the customers within your market.

It's useful when segmenting your market and establishing your buyer personas.

Primary market research tends to fall into one of two buckets:

  • Exploratory Primary Research: This kind of primary market research normally takes place as a first step — before any specific research has been performed — and may involve open-ended interviews or surveys with small numbers of people.
  • Specific Primary Research: This type of research often follows exploratory research. In specific research, you take a smaller or more precise segment of your audience and ask questions aimed at solving a suspected problem.

Secondary Research

Secondary research is all the data and public records you have at your disposal to draw conclusions from (e.g. trend reports, market statistics, industry content, and sales data you already have on your business).

Secondary research is particularly useful for analyzing your competitors . The main buckets your secondary market research will fall into include:

  • Public Sources: These sources are your first and most-accessible layer of material when conducting secondary market research. They're often free to find and review — like government statistics (e.g., from the U.S. Census Bureau ).
  • Commercial Sources: These sources often come in the form of pay-to-access market reports, consisting of industry insight compiled by a research agency like Pew , Gartner , or Forrester .
  • Internal Sources: This is the market data your organization already has like average revenue per sale, customer retention rates, and other historical data that can help you draw conclusions on buyer needs.
  • Focus Groups
  • Product/ Service Use Research
  • Observation-Based Research
  • Buyer Persona Research
  • Market Segmentation Research
  • Pricing Research
  • Competitive Analysis Research
  • Customer Satisfaction and Loyalty Research
  • Brand Awareness Research
  • Campaign Research

1. Interviews

Interviews allow for face-to-face discussions so you can allow for a natural flow of conversation. Your interviewees can answer questions about themselves to help you design your buyer personas and shape your entire marketing strategy.

2. Focus Groups

Focus groups provide you with a handful of carefully-selected people that can test out your product and provide feedback. This type of market research can give you ideas for product differentiation.

3. Product/Service Use Research

Product or service use research offers insight into how and why your audience uses your product or service. This type of market research also gives you an idea of the product or service's usability for your target audience.

4. Observation-Based Research

Observation-based research allows you to sit back and watch the ways in which your target audience members go about using your product or service, what works well in terms of UX , and which aspects of it could be improved.

5. Buyer Persona Research

Buyer persona research gives you a realistic look at who makes up your target audience, what their challenges are, why they want your product or service, and what they need from your business or brand.

6. Market Segmentation Research

Market segmentation research allows you to categorize your target audience into different groups (or segments) based on specific and defining characteristics. This way, you can determine effective ways to meet their needs.

7. Pricing Research

Pricing research helps you define your pricing strategy . It gives you an idea of what similar products or services in your market sell for and what your target audience is willing to pay.

8. Competitive Analysis

Competitive analyses give you a deep understanding of the competition in your market and industry. You can learn about what's doing well in your industry and how you can separate yourself from the competition .

9. Customer Satisfaction and Loyalty Research

Customer satisfaction and loyalty research gives you a look into how you can get current customers to return for more business and what will motivate them to do so (e.g., loyalty programs , rewards, remarkable customer service).

10. Brand Awareness Research

Brand awareness research tells you what your target audience knows about and recognizes from your brand. It tells you about the associations people make when they think about your business.

11. Campaign Research

Campaign research entails looking into your past campaigns and analyzing their success among your target audience and current customers. The goal is to use these learnings to inform future campaigns.

  • Define your buyer persona.
  • Identify a persona group to engage.
  • Prepare research questions for your market research participants.
  • List your primary competitors.
  • Summarize your findings.

1. Define your buyer persona.

You have to understand who your customers are and how customers in your industry make buying decisions.

This is where your buyer personas come in handy. Buyer personas — sometimes referred to as marketing personas — are fictional, generalized representations of your ideal customers.

Use a free tool to create a buyer persona that your entire company can use to market, sell, and serve better.

study design research article

10 Free Competitive Analysis Templates

Track and analyze your competitors with these ten free planning templates.

  • SWOT Analysis
  • Battle Cards
  • Feature Comparison
  • Strategic Overview

Identifying Content Competitors

Search engines are your best friends in this area of secondary market research.

To find the online publications with which you compete, take the overarching industry term you identified in the section above, and come up with a handful of more specific industry terms your company identifies with.

A catering business, for example, might generally be a “food service” company, but also consider itself a vendor in “event catering,” “cake catering,” or “baked goods.” Once you have this list, do the following:

  • Google it. Don't underestimate the value in seeing which websites come up when you run a search on Google for the industry terms that describe your company. You might find a mix of product developers, blogs, magazines, and more.
  • Compare your search results against your buyer persona. If the content the website publishes seems like the stuff your buyer persona would want to see, it's a potential competitor, and should be added to your list of competitors.

5. Summarize your findings.

Feeling overwhelmed by the notes you took? We suggest looking for common themes that will help you tell a story and create a list of action items.

To make the process easier, try using your favorite presentation software to make a report, as it will make it easy to add in quotes, diagrams, or call clips.

Feel free to add your own flair, but the following outline should help you craft a clear summary:

  • Background: Your goals and why you conducted this study.
  • Participants: Who you talked to. A table works well so you can break groups down by persona and customer/prospect.
  • Executive Summary : What were the most interesting things you learned? What do you plan to do about it?
  • Awareness: Describe the common triggers that lead someone to enter into an evaluation. (Quotes can be very powerful.)
  • Consideration: Provide the main themes you uncovered, as well as the detailed sources buyers use when conducting their evaluation.
  • Decision: Paint the picture of how a decision is really made by including the people at the center of influence and any product features or information that can make or break a deal.
  • Action Plan: Your analysis probably uncovered a few campaigns you can run to get your brand in front of buyers earlier and/or more effectively. Provide your list of priorities, a timeline, and the impact it will have on your business.

Within a market research kit, there are a number of critical pieces of information for your business‘s success. Let’s take a look at these elements.

Pro Tip: Upon downloading HubSpot's free Market Research Kit , you'll receive editable templates for each of the given parts of the kit, instructions on how to use the kit, and a mock presentation that you can edit and customize.

study design research article

What Is a Competitive Analysis — and How Do You Conduct One?

The Beginner's Guide to the Competitive Matrix [+ Templates]

The Beginner's Guide to the Competitive Matrix [+ Templates]

What is a Competitive Analysis — and How Do You Conduct One?

What is a Competitive Analysis — and How Do You Conduct One?

9 Best Marketing Research Methods to Know Your Buyer Better [+ Examples]

9 Best Marketing Research Methods to Know Your Buyer Better [+ Examples]

SWOT Analysis: How To Do One [With Template & Examples]

SWOT Analysis: How To Do One [With Template & Examples]

28 Tools & Resources for Conducting Market Research

28 Tools & Resources for Conducting Market Research

TAM, SAM & SOM: What Do They Mean & How Do You Calculate Them?

TAM, SAM & SOM: What Do They Mean & How Do You Calculate Them?

How to Run a Competitor Analysis [Free Guide]

How to Run a Competitor Analysis [Free Guide]

5 Challenges Marketers Face in Understanding Audiences [New Data + Market Researcher Tips]

5 Challenges Marketers Face in Understanding Audiences [New Data + Market Researcher Tips]

Causal Research: The Complete Guide

Causal Research: The Complete Guide

Free Guide & Templates to Help Your Market Research

Marketing software that helps you drive revenue, save time and resources, and measure and optimize your investments — all on one easy-to-use platform

IMAGES

  1. Clinical Research: A Review of Study Designs, Hypotheses, Errors

    study design research article

  2. (PDF) Selecting the appropriate study design for your research

    study design research article

  3. Study designs in biomedical research: an introduction to the different

    study design research article

  4. (PDF) Scientific study designs for research: an overview

    study design research article

  5. What is Research Design in Qualitative Research

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  6. How to Write a Research Design: Guide For Students

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VIDEO

  1. Before-and-after Study Design

  2. Study Design

  3. Implementation Science Education Series Seminar 5: Outcomes and Measures

  4. 32

  5. Wake-Up Call

  6. What is research design? #how to design a research advantages of research design

COMMENTS

  1. Planning Qualitative Research: Design and Decision Making for New

    While many books and articles guide various qualitative research methods and analyses, there is currently no concise resource that explains and differentiates among the most common qualitative approaches. We believe novice qualitative researchers, students planning the design of a qualitative study or taking an introductory qualitative research course, and faculty teaching such courses can ...

  2. Basics of Research Design: A Guide to selecting appropriate research design

    2.4 Choosing the correct research design for a research. The essence of research design is to achieve the research objective clearly, objectively, precisely and economically, control extraneous ...

  3. Study designs: Part 7

    In the previous six articles in this series on study designs, we have looked at different types of primary research study designs which are used to answer research questions. In this article, we describe the systematic review, a type of secondary research design that is used to summarize the results of prior primary research studies. Systematic reviews are considered the highest level of ...

  4. Study designs: Part 1

    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.

  5. Research: Articulating Questions, Generating Hypotheses, and Choosing

    CHOOSING THE STUDY DESIGN. The research question is paramount in deciding what research design and methods you are going to use. There are no inherently bad research designs. The rightness or wrongness of the decision about the research design is based simply on whether it is suitable for answering the research question that you have posed.

  6. An overview of study designs

    The ability to find, critically appraise and use evidence to develop new interventions is fundamental to evidence-based medicine. Different study designs have their own advantages and disadvantages, and provide different evidentiary value. This article provides an overview of clinical trials, illustrating that, ultimately, the study design ...

  7. How to choose your study design

    First, by the specific research question. That is, if the question is one of 'prevalence' (disease burden) then the ideal is a cross-sectional study; if it is a question of 'harm' - a case-control study; prognosis - a cohort and therapy - a RCT. Second, by what resources are available to you. This includes budget, time, feasibility re-patient ...

  8. An introduction to different types of study design

    Prospective: we follow the individuals in the future to know who will develop the disease. Retrospective: we look to the past to know who developed the disease (e.g. using medical records) This design is the strongest among the observational studies. For example - to find out the relative risk of developing chronic obstructive pulmonary ...

  9. Study Design in Medical Research

    Medical research studies can be split into five phases—planning, performance, documentation, analysis, and publication ( 1, 2 ). Aside from financial, organizational, logistical and personnel questions, scientific study design is the most important aspect of study planning. The significance of study design for subsequent quality, the ...

  10. What Is a Research Design

    A research design is a strategy for answering your research question using empirical data. Creating a research design means making decisions about: Your overall research objectives and approach. Whether you'll rely on primary research or secondary research. Your sampling methods or criteria for selecting subjects. Your data collection methods.

  11. Epidemiology Of Study Design

    In epidemiology, researchers are interested in measuring or assessing the relationship of exposure with a disease or an outcome. As a first step, they define the hypothesis based on the research question and then decide which study design will be best suited to answer that question. How the researcher conducts the investigation is directed by the chosen study design. The study designs can be ...

  12. (PDF) Qualitative Case Study Methodology: Study Design and

    McMaster University, West Hamilton, Ontario, Canada. Qualitative case study methodology prov ides tools for researchers to study. complex phenomena within their contexts. When the approach is ...

  13. Quantifying and addressing the prevalence and bias of study designs in

    A hypothetical study set-up is shown where the abundance of birds in three impact and control replicates (e.g., fields represented by blocks in a row) are monitored before and after an impact (e.g ...

  14. How to design and conduct a megastudy

    The measured outcome(s) is the outcome(s) measured in the megastudy and the actual outcome(s) of interest refers to the phenomenon or phenomena of interest beyond the study, to which one would ...

  15. Study designs

    An experimental comparison study in which participants are allocated to treatment/intervention or control/placebo groups using a random mechanism (see randomisation). Best for study the effect of an intervention. Advantages: unbiased distribution of confounders; blinding more likely; randomisation facilitates statistical analysis.

  16. Clarification of research design, research methods, and research

    The comparison analysis obtained in this research can provide guidance for PA researchers, students and practitioners when considering the research design most appropriate for their study. To achieve the research purpose, a comparison analysis was conducted to study the differences in research design perspectives and approaches. Three dominant ...

  17. Basics of study design: Practical considerations

    Often, the most difficult task for someone new to research is developing a practical study idea. This section will explain a detailed process for creating a formal research protocol. We will focus on two common sticking points: (1) finding a good idea, and (2) developing a good idea into a problem statement.

  18. (PDF) Research Design

    design'. The research design refers to the overall strategy that you choose to integrate the. different components of the study in a coherent and logical way, thereby, ensuring you will ...

  19. Literature Reviews: Types of Clinical Study Designs

    Animal Research Studies Studies conducted using animal subjects. Example: Intranasal leptin reduces appetite and induces weight loss in rats with diet-induced obesity (DIO). Schulz C, Paulus K, Jöhren O, Lehnert H. Endocrinology. 2012 Jan;153(1):143-53. Test-tube Lab Research "Test tube" experiments conducted in a controlled laboratory setting.

  20. Design Studies

    About the journal. Foster Interdisciplinary Design Discussions: Create a space for interdisciplinary discussions on fundamental design elements, including process, cognition, and philosophy, while emphasising research, theory, and innovative outcomes. Explore Design's Theoretical Evolution: Assess the history and future of design by examining ...

  21. What is Research Design? Types, Elements and Examples

    Q: Can research design be modified during the course of a study? Yes, research design can be modified during the course of a study based on emerging insights, practical constraints, or unforeseen circumstances. Research is an iterative process and, as new data is collected and analyzed, it may become necessary to adjust or refine the research ...

  22. (PDF) An Overview of Research Study Designs in Quantitative Research

    The study was conducted by the literature review of similar articles on research study designs using Google Scholar, African Journal Online (AJOL), PubMed, MEDLINE and CINAHL as databases.

  23. Design Practice Research: Conditions and Outcomes

    Practice Research within Studies of Design. The field of design research has been in formation since the practice of design became gradually institutionalized in art schools, polytechnics, and universities (Alexander Citation 1964; Archer Citation 1979; Cross Citation 1999; Citation Simon1969) to become an object of academic investigation and site for doctoral study (Phillips Citation 2021 ...

  24. Market Research: A How-To Guide and Template

    Exploratory Primary Research: This kind of primary market research normally takes place as a first step — before any specific research has been performed — and may involve open-ended interviews or surveys with small numbers of people. Specific Primary Research: This type of research often follows exploratory research. In specific research ...