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• How to Write a Strong Hypothesis | Steps & Examples

How to Write a Strong Hypothesis | Steps & Examples

Published on May 6, 2022 by Shona McCombes . Revised on November 20, 2023.

A hypothesis is a statement that can be tested by scientific research. If you want to test a relationship between two or more variables, you need to write hypotheses before you start your experiment or data collection .

Example: Hypothesis

Daily apple consumption leads to fewer doctor’s visits.

Table of contents

What is a hypothesis, developing a hypothesis (with example), hypothesis examples, other interesting articles, frequently asked questions about writing hypotheses.

A hypothesis states your predictions about what your research will find. It is a tentative answer to your research question that has not yet been tested. For some research projects, you might have to write several hypotheses that address different aspects of your research question.

A hypothesis is not just a guess – it should be based on existing theories and knowledge. It also has to be testable, which means you can support or refute it through scientific research methods (such as experiments, observations and statistical analysis of data).

Variables in hypotheses

Hypotheses propose a relationship between two or more types of variables .

• An independent variable is something the researcher changes or controls.
• A dependent variable is something the researcher observes and measures.

If there are any control variables , extraneous variables , or confounding variables , be sure to jot those down as you go to minimize the chances that research bias  will affect your results.

In this example, the independent variable is exposure to the sun – the assumed cause . The dependent variable is the level of happiness – the assumed effect .

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Step 1. ask a question.

Writing a hypothesis begins with a research question that you want to answer. The question should be focused, specific, and researchable within the constraints of your project.

Step 2. Do some preliminary research

Your initial answer to the question should be based on what is already known about the topic. Look for theories and previous studies to help you form educated assumptions about what your research will find.

At this stage, you might construct a conceptual framework to ensure that you’re embarking on a relevant topic . This can also help you identify which variables you will study and what you think the relationships are between them. Sometimes, you’ll have to operationalize more complex constructs.

Step 3. Formulate your hypothesis

Now you should have some idea of what you expect to find. Write your initial answer to the question in a clear, concise sentence.

4. Refine your hypothesis

You need to make sure your hypothesis is specific and testable. There are various ways of phrasing a hypothesis, but all the terms you use should have clear definitions, and the hypothesis should contain:

• The relevant variables
• The specific group being studied
• The predicted outcome of the experiment or analysis

5. Phrase your hypothesis in three ways

To identify the variables, you can write a simple prediction in  if…then form. The first part of the sentence states the independent variable and the second part states the dependent variable.

In academic research, hypotheses are more commonly phrased in terms of correlations or effects, where you directly state the predicted relationship between variables.

If you are comparing two groups, the hypothesis can state what difference you expect to find between them.

6. Write a null hypothesis

If your research involves statistical hypothesis testing , you will also have to write a null hypothesis . The null hypothesis is the default position that there is no association between the variables. The null hypothesis is written as H 0 , while the alternative hypothesis is H 1 or H a .

• H 0 : The number of lectures attended by first-year students has no effect on their final exam scores.
• H 1 : The number of lectures attended by first-year students has a positive effect on their final exam scores.

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Sampling methods
• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

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A hypothesis is not just a guess — it should be based on existing theories and knowledge. It also has to be testable, which means you can support or refute it through scientific research methods (such as experiments, observations and statistical analysis of data).

Null and alternative hypotheses are used in statistical hypothesis testing . The null hypothesis of a test always predicts no effect or no relationship between variables, while the alternative hypothesis states your research prediction of an effect or relationship.

Hypothesis testing is a formal procedure for investigating our ideas about the world using statistics. It is used by scientists to test specific predictions, called hypotheses , by calculating how likely it is that a pattern or relationship between variables could have arisen by chance.

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Module 1: Introduction to Biology

Experiments and hypotheses, learning outcomes.

• Form a hypothesis and use it to design a scientific experiment

Now we’ll focus on the methods of scientific inquiry. Science often involves making observations and developing hypotheses. Experiments and further observations are often used to test the hypotheses.

A scientific experiment is a carefully organized procedure in which the scientist intervenes in a system to change something, then observes the result of the change. Scientific inquiry often involves doing experiments, though not always. For example, a scientist studying the mating behaviors of ladybugs might begin with detailed observations of ladybugs mating in their natural habitats. While this research may not be experimental, it is scientific: it involves careful and verifiable observation of the natural world. The same scientist might then treat some of the ladybugs with a hormone hypothesized to trigger mating and observe whether these ladybugs mated sooner or more often than untreated ones. This would qualify as an experiment because the scientist is now making a change in the system and observing the effects.

Forming a Hypothesis

When conducting scientific experiments, researchers develop hypotheses to guide experimental design. A hypothesis is a suggested explanation that is both testable and falsifiable. You must be able to test your hypothesis, and it must be possible to prove your hypothesis true or false.

For example, Michael observes that maple trees lose their leaves in the fall. He might then propose a possible explanation for this observation: “cold weather causes maple trees to lose their leaves in the fall.” This statement is testable. He could grow maple trees in a warm enclosed environment such as a greenhouse and see if their leaves still dropped in the fall. The hypothesis is also falsifiable. If the leaves still dropped in the warm environment, then clearly temperature was not the main factor in causing maple leaves to drop in autumn.

In the Try It below, you can practice recognizing scientific hypotheses. As you consider each statement, try to think as a scientist would: can I test this hypothesis with observations or experiments? Is the statement falsifiable? If the answer to either of these questions is “no,” the statement is not a valid scientific hypothesis.

Practice Questions

Determine whether each following statement is a scientific hypothesis.

Air pollution from automobile exhaust can trigger symptoms in people with asthma.

• No. This statement is not testable or falsifiable.
• No. This statement is not testable.
• No. This statement is not falsifiable.
• Yes. This statement is testable and falsifiable.

Natural disasters, such as tornadoes, are punishments for bad thoughts and behaviors.

a: No. This statement is not testable or falsifiable. “Bad thoughts and behaviors” are excessively vague and subjective variables that would be impossible to measure or agree upon in a reliable way. The statement might be “falsifiable” if you came up with a counterexample: a “wicked” place that was not punished by a natural disaster. But some would question whether the people in that place were really wicked, and others would continue to predict that a natural disaster was bound to strike that place at some point. There is no reason to suspect that people’s immoral behavior affects the weather unless you bring up the intervention of a supernatural being, making this idea even harder to test.

Testing a Vaccine

Let’s examine the scientific process by discussing an actual scientific experiment conducted by researchers at the University of Washington. These researchers investigated whether a vaccine may reduce the incidence of the human papillomavirus (HPV). The experimental process and results were published in an article titled, “ A controlled trial of a human papillomavirus type 16 vaccine .”

Preliminary observations made by the researchers who conducted the HPV experiment are listed below:

• Human papillomavirus (HPV) is the most common sexually transmitted virus in the United States.
• There are about 40 different types of HPV. A significant number of people that have HPV are unaware of it because many of these viruses cause no symptoms.
• Some types of HPV can cause cervical cancer.
• About 4,000 women a year die of cervical cancer in the United States.

Practice Question

Researchers have developed a potential vaccine against HPV and want to test it. What is the first testable hypothesis that the researchers should study?

• HPV causes cervical cancer.
• People should not have unprotected sex with many partners.
• People who get the vaccine will not get HPV.
• The HPV vaccine will protect people against cancer.

Experimental Design

You’ve successfully identified a hypothesis for the University of Washington’s study on HPV: People who get the HPV vaccine will not get HPV.

The next step is to design an experiment that will test this hypothesis. There are several important factors to consider when designing a scientific experiment. First, scientific experiments must have an experimental group. This is the group that receives the experimental treatment necessary to address the hypothesis.

The experimental group receives the vaccine, but how can we know if the vaccine made a difference? Many things may change HPV infection rates in a group of people over time. To clearly show that the vaccine was effective in helping the experimental group, we need to include in our study an otherwise similar control group that does not get the treatment. We can then compare the two groups and determine if the vaccine made a difference. The control group shows us what happens in the absence of the factor under study.

However, the control group cannot get “nothing.” Instead, the control group often receives a placebo. A placebo is a procedure that has no expected therapeutic effect—such as giving a person a sugar pill or a shot containing only plain saline solution with no drug. Scientific studies have shown that the “placebo effect” can alter experimental results because when individuals are told that they are or are not being treated, this knowledge can alter their actions or their emotions, which can then alter the results of the experiment.

Moreover, if the doctor knows which group a patient is in, this can also influence the results of the experiment. Without saying so directly, the doctor may show—through body language or other subtle cues—their views about whether the patient is likely to get well. These errors can then alter the patient’s experience and change the results of the experiment. Therefore, many clinical studies are “double blind.” In these studies, neither the doctor nor the patient knows which group the patient is in until all experimental results have been collected.

Both placebo treatments and double-blind procedures are designed to prevent bias. Bias is any systematic error that makes a particular experimental outcome more or less likely. Errors can happen in any experiment: people make mistakes in measurement, instruments fail, computer glitches can alter data. But most such errors are random and don’t favor one outcome over another. Patients’ belief in a treatment can make it more likely to appear to “work.” Placebos and double-blind procedures are used to level the playing field so that both groups of study subjects are treated equally and share similar beliefs about their treatment.

The scientists who are researching the effectiveness of the HPV vaccine will test their hypothesis by separating 2,392 young women into two groups: the control group and the experimental group. Answer the following questions about these two groups.

• This group is given a placebo.
• This group is deliberately infected with HPV.
• This group is given nothing.
• This group is given the HPV vaccine.
• a: This group is given a placebo. A placebo will be a shot, just like the HPV vaccine, but it will have no active ingredient. It may change peoples’ thinking or behavior to have such a shot given to them, but it will not stimulate the immune systems of the subjects in the same way as predicted for the vaccine itself.
• d: This group is given the HPV vaccine. The experimental group will receive the HPV vaccine and researchers will then be able to see if it works, when compared to the control group.

Experimental Variables

A variable is a characteristic of a subject (in this case, of a person in the study) that can vary over time or among individuals. Sometimes a variable takes the form of a category, such as male or female; often a variable can be measured precisely, such as body height. Ideally, only one variable is different between the control group and the experimental group in a scientific experiment. Otherwise, the researchers will not be able to determine which variable caused any differences seen in the results. For example, imagine that the people in the control group were, on average, much more sexually active than the people in the experimental group. If, at the end of the experiment, the control group had a higher rate of HPV infection, could you confidently determine why? Maybe the experimental subjects were protected by the vaccine, but maybe they were protected by their low level of sexual contact.

To avoid this situation, experimenters make sure that their subject groups are as similar as possible in all variables except for the variable that is being tested in the experiment. This variable, or factor, will be deliberately changed in the experimental group. The one variable that is different between the two groups is called the independent variable. An independent variable is known or hypothesized to cause some outcome. Imagine an educational researcher investigating the effectiveness of a new teaching strategy in a classroom. The experimental group receives the new teaching strategy, while the control group receives the traditional strategy. It is the teaching strategy that is the independent variable in this scenario. In an experiment, the independent variable is the variable that the scientist deliberately changes or imposes on the subjects.

Dependent variables are known or hypothesized consequences; they are the effects that result from changes or differences in an independent variable. In an experiment, the dependent variables are those that the scientist measures before, during, and particularly at the end of the experiment to see if they have changed as expected. The dependent variable must be stated so that it is clear how it will be observed or measured. Rather than comparing “learning” among students (which is a vague and difficult to measure concept), an educational researcher might choose to compare test scores, which are very specific and easy to measure.

In any real-world example, many, many variables MIGHT affect the outcome of an experiment, yet only one or a few independent variables can be tested. Other variables must be kept as similar as possible between the study groups and are called control variables . For our educational research example, if the control group consisted only of people between the ages of 18 and 20 and the experimental group contained people between the ages of 30 and 35, we would not know if it was the teaching strategy or the students’ ages that played a larger role in the results. To avoid this problem, a good study will be set up so that each group contains students with a similar age profile. In a well-designed educational research study, student age will be a controlled variable, along with other possibly important factors like gender, past educational achievement, and pre-existing knowledge of the subject area.

What is the independent variable in this experiment?

• Sex (all of the subjects will be female)
• Presence or absence of the HPV vaccine
• Presence or absence of HPV (the virus)

List three control variables other than age.

What is the dependent variable in this experiment?

• Sex (male or female)
• Rates of HPV infection
• Age (years)
• Revision and adaptation. Authored by : Shelli Carter and Lumen Learning. Provided by : Lumen Learning. License : CC BY-NC-SA: Attribution-NonCommercial-ShareAlike
• Scientific Inquiry. Provided by : Open Learning Initiative. Located at : https://oli.cmu.edu/jcourse/workbook/activity/page?context=434a5c2680020ca6017c03488572e0f8 . Project : Introduction to Biology (Open + Free). License : CC BY-NC-SA: Attribution-NonCommercial-ShareAlike

A concise guide to reproducible research using secondary data

Chapter 2 formulating a hypothesis.

“There is no single best way to develop a research idea.” ( Pischke 2012 )

2.1 How do you develop a research question and formulate a hypothesis?

You decide to undertake a scientific project. Where do you start? First, you need to find a research question that interests you and formulate a hypothesis. We will introduce some key terminology, steps you can take, and examples how to develop research questions. Note that .

What if someone assigns a topic to me? For students attending undergraduate and graduate courses that often pick topics from a list, all of these steps are equally important and necessary. You still need to formulate a research question and a hypothesis. And it is important to clarify the relevance of your topic for yourself.

When thinking about a research question, you need to identify a topic that is:

• Relevant , important in the world and interesting to you as a researcher: Does working on the topic excites you? You will spend many hours thinking about it and working on it. Therefore, it should be interesting and engaging enough for you to motivate your continued work on this topic.
• Specific : not too broad and not too narrow
• Feasible to research within a given time frame: Is it possible to answer the research question based on your time budget, data and additional resources.

How do you find a topic or develop a feasible research idea in the first place? Finding an idea is not difficult, the critical part is to find a good idea. How do you do that? There is no one specific way how one gets an idea, rather there is a myriad of ways how people come up with potential ideas (for example, as stated by Varian ( 2016 ) ).

You can find inspiration by

• Looking at insights from the world around you: your own life and experiences, observe the behavior of people around you
• Talking to people around you, experts, other students, family members
• Talking to individuals outside your field (non-economists)
• Talking to professionals working in the area you are interested in (you may use social media and professional platforms like LinkedIN or Twitter to make contact)
• Reading journal articles from other non-economic social sciences and the medical literature
• What are the issues being discussed?
• How do these issues affect people’s lives?

In addition you could

• Go to virtual and in-person seminars, for example, the Essen Health Economics Seminar
• Look at abstracts of scientific articles and working papers
• Look at the literature in a specific field you are interested in, for example, screening complete issues of journals or editorials about certain research advancements. By reading this literature you might come up with the idea on how to extend and refine previous research.

Once you identified a research question that is of interest to you, you need to define a hypothesis.

2.2 What is a hypothesis?

A hypothesis is a statement that introduces your research question and suggests the results you might find. It is an educated guess. You start by posing an economic question and formulate a hypothesis about this question. Then you test it with your data and empirical analysis and either accept or reject the hypothesis. It constitutes the main basis of your scientific investigation and you should be careful when creating it.

2.2.1 Develop a hypothesis

Before you formulate your hypothesis, read up on the topic of interest. This should provide you with sufficient information to narrow down your research question. Once you find your question you need to develop a hypothesis, which contains a statement of your expectations regarding your research question’s results. You propose to prove your hypothesis with your research by testing the relationship between two variables of interest. Thus, a hypothesis should be testable with the data at hand. There are two types of hypotheses: alternative or null. Null states that there is no effect. Alternative states that there is an effect.

There is an alternative view on this that suggests one should not look at the literature too early on in the idea-generating process to not be influenced and shaped by someone else’s ideas ( Varian 2016 ) . According to this view you can spend some time (i.e. a few weeks) trying to develop your own original idea. Even if you end up with an idea that has already been pursued by someone else, this will still provide you with good practice in developing publishable ideas. After you have developed an idea and made sure that it was not yet investigated in the literature, you can start conducting a systematic literature review. By doing this, you can find some other interesting insights from the work of others that you can synthesize in your own work to produce something novel and original.

2.2.2 Identify relevant literature

For your research project you will need to identify and collect previous relevant literature. It should involve a thorough search of the keywords in relevant databases and journals. Place emphasis on articles from high-ranking journals with significant numbers of citations. This will give you an indication of the most influential and important work in the field. Once you identify and collect the relevant literature for your topic, you will need to critically synthesize it in your literature review.

When you perform your literature review, consider theories that may inform your research question. For example, when studying physician behavior you may consider principal-agent theory.

2.2.3 Research question or literature review: the chicken or the egg problem?

Whether you start reading the literature first or by developing an idea may depend on your level (graduate student, early career researcher) and other goals. However, thinking freely about what you like to investigate first may help to critically develop a feasible and interesting research question.

We highlight an example how to start with investigating the real world and subsequently posing a research question ( “How to Write a Strong Hypothesis Steps and Examples ” 2019 ; “Developing Strong Research Questions Criteria and Examples ” 2019 ; Schilbach 2019 ) . For example, based on your observation you notice that people spend extensive amount of time looking at their smartphones. Maybe even you yourself engage in the same behavior. In addition, you read a BBC News article Social media damages teenagers’ mental health, report says .

(#fig:social_media)Social media and mental health

Source: BBC

You decide to translate this article and your observations into a research question : How does social media use affect mental health? Before you formulate your hypothesis, read up on the topic of interest. Read economic, medical and other social science literature on the topic. There is likely to be a vast amount of literature from non-economic fields that are doing research on your topic of interest, for example, psychology or neuroscience. Familiarize yourself with it and master it. Do not get distracted by different scientific methodologies and techniques that might seem not up-to-par to the economic studies (small sample sizes, endogeneity, uncovering association rather than causation, etc.), but rather focus on suggestions of potential mechanisms.

A hypothesis is then your research question distilled into a one sentence statement, which presents your expectations regarding the results. You propose to prove your hypothesis by testing the relationship between two variables of interest with the data at hand. There are two types of hypotheses: alternative or null. The null hypothesis states that there is no effect. The alternative hypothesis states that there is an effect.

A hypothesis related to the above-stated research question could be: The increased use of social media among teenagers leads to (is associated with) worse mental health outcomes, i.e. increased incidence of depression, eating disorders, worse well-being and lower self-esteem. It suggests a direction of a relationship that you expect to find that is guided by your observations and existing evidence. It is testable with scientific research methods by using statistical analysis of the relevant data.

Your hypothesis suggests a relationship between two variables: social media use (your independent variable \(X\) ) and mental health (dependent variable \(Y\) ). It could be framed in terms of correlation (is associated with) or causation (leads to). This should be reflected in the choice of scientific investigation you decide to undertake.

The null hypothesis is: There is no relationship between social media use among teenagers and their mental health .

2.3 Resources box

2.3.1 how to develop strong research questions.

• The form of the research process
• Varian, H. R. (2016). How to build an economic model in your spare time. The American Economist, 61(1), 81-90.

2.3.2 Identify relevant literature from major general interest and field literature

To identify the relevant literature you can

• use academic search engines such as Google Scholar, Web of Science, EconLit, PubMed.
• search working paper series such as the National Bureau of Economic Research , NetEc or IZA
• search more general resource sites such as Resources for Economists
• go to the library/use library database

2.3.3 Assess the quality of a journal article

Several rankings may help to assess the quality of research you consider

• Journals of general interest and by field in economics and management - For German-speaking countries, consider the VWL / BWL Handelsblatt Ranking for economics and management - The German Association of Management Scholars provides an expert-based ranking VHB JourQual 3.0, Teilranking Management im Gesundheitswesen - Web of Science Impact Factors - Scimago
• Health Economics, Health Services and Health Care Managment Research: Health Economics Journals List
• Be aware that like in any other domain there are predatory publishing practices .

Use tools to investigate how a journal article is connected to other works

• Citationgecko
• Connected papers
• scite_ – a tool to get a first impression whether a study is disputed or academic consensus

2.3.4 Organize your literature

• Zotero (free of charge)
• Mendeley (free of charge)
• EndNote (potentially free of charge via your university)
• Citavi (potentially free of charge via your university)
• BibTEX if you work with TEX
• Excel spread sheet

2.4 Checklist to get started with formulating your hypothesis

• Find an interesting and relevant research topic, if not assigned
• Try to suck up all information you can easily obtain from various sources within and outside academic literature
• Formulate one compelling research question
• Find the best available empirical and theoretical evidence that is related to your research question
• Formulate a hypothesis
• Check whether data are available for analysis
• Challenge your idea with your fellows or senior researchers

2.5 Example: Hellerstein ( 1998 )

As an illustration of the research process of formulating a hypothesis, designing a study, running a study, collecting and analyzing the data and, finally, reporting the study, we provide an example by replicating Judith K. Hellerstein’s paper “The Importance of the Physician in the Generic versus Trade-Name Prescription Decision” that was published in 1998 in the RAND Journal of Economics.

Hellerstein’s 1998 paper has impacted discussion about behavioral factors of physician decisions and pharmaceutical markets over two decades. The study received 448 citations on Google Scholar since 1998 by 27/03/2022, including recent mentions in top field journals such as Journal of Public Economics (2021) , Journal of Health Economics (2019) , and Health Economics (2019) .

Figure 2.1: Connected graph of Hellerstein ( 1998 ) , February 2022

Figure 2.1 shows a connected graph of prior and derivative works related to the study.

The work has impacted the literature researching the role of physician behavior and its influence on access, adoption and diffusion of health services, moral hazard and incentives in prescription and treatment decisions and the influence of different payment schemes, and a vast body of literature studying the pharmaceutical market.

The research that has been influenced by Hellerstein includes evidence on:

• generic drug entries and market efficiency
• the effectiveness of pharmaceutical promotion
• the effectiveness of price regulations
• the role of patents and dynamics of market segmentation

At the end of each chapter, we demonstrate insights into this study that we replicate.

2.5.1 Context of the study - escalating health expenditures

In the United States, the total prescription drug expenditure in 2020 marked about 358.7 billion US Dollars ( Statista n.d. ) . The prescription of generic drugs in comparison to more expensive brand-name versions is an option in reducing the total health care expenditure. Generic drugs are bioequivalent in the active ingredients and can serve as a channel to contain prescription expenditure ( Kesselheim 2008 ) as generic drugs are between 20 and 90% cheaper than their trade-name alternatives ( Dunne et al. 2013 ) .

2.5.2 Research question - How does a patient’s insurance status influence the physician’s choice between generic compared to brand-name drugs?

Physicians are faced with a multitude of medication options, including the choice between generic and trade-name drugs. Physicians ideally act as agents for their patients to identify the best available treatment option based on their needs. Choosing the best treatment entails cost of coordination and cognition. The prescription of generic drugs may serve as an example to what extent physicians customize treatments according to patients’ needs with regards to cost. From an economic point of view we may expect that once a generic drug is available, a perfectly rational agent (i.e. physician) would prescribe a generic drug instead of the trade-name version if therapeutically identical ( Dranove 1989 ) . This leads to the following research question: “Do physicians vary their prescription decisions on a patient-by-patient basis or do they systematically prescribe the same version, trade-name or generic, to all patients?” .

The 1998 Hellerstein’s study examines two hypotheses:

• The physician prescribing choice influences the selection of a generic over a brand-name drug
• The patient’s insurance status influences the physician’s choice between generic and brand-name drugs.

For the purpose of this example and in the replication exercise we focus on the second aspect.

2.5.3 Hypothesis

The paper formulates the following hypothesis:

Physicians are more likely to prescribe generics to patients who do not have insurance coverage for prescription pharmaceuticals (moral hazard in insurance)

Hellerstein ( 1998 ) discusses that, based on insurance status, some patients may demand certain care more than others. If, for example, the prescription drug is reimbursed by the patient’s health insurance, this may cause overconsumption. This behavior can potentially differ by the patient’s insurance scheme. A patient that has no insurance and, thus, does not get any reimbursement for prescription drugs, might have a higher incentive to demand cheaper generic drugs ( Danzon and Furukawa 2011 ) than a patient with insurance that covers prescription drugs, either generic or trade-name. Given that the United States have different insurance schemes with varying prescription drug coverage, it is of interest to investigate the role of a patient’s insurance status in the physician’s choice between generic compared to brand-name drugs.

Hellerstein ( 1998 ) considers a patient’s insurance status as a matter of dividing the study population in groups for which the choice between generic and brand-name drugs differs. She suggests that There is a relationship between the prescription of a generic drug and insurance status of a patient. ( Hellerstein 1998 ) .

Providing answers to a research question requires formulating and testing a hypothesis. Based on logic, theory or previous research, a hypothesis proposes an expected relationship within the given data. According to her research question, Hellerstein hypothesizes that: Physicians are more likely to prescribe generics to patients who do not have insurance coverage for prescription pharmaceuticals.

Specifically, she writes “if there is moral hazard in insurance when it comes to physician prescription behavior, there will be differences in the propensity of physicians to prescribe low-cost generic drugs, and these differences will be (partially) a function of the insurance held by the patient. In particular, if moral hazard exists, patients with extensive insurance coverage for prescription drugs (like those on Medicaid in 1989) should receive prescriptions written for generic drugs less frequently than patients with no prescription drug coverage.” ( Hellerstein 1998, 113 )

Based on Hellerstein’s considerations, we expect the effect of the insurance status on whether a patient receives a generic to be different from zero. To obtain a testable null hypothesis, we reformulate this relationship so that we reject the hypothesis if our expectations are correct. This means, if we expect to see an effect of insurance on prescriptions of generics, our null hypothesis is that insurance status has no effect on the outcome (prescription of generic drugs). No moral hazard arises from having obtained insurance.

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Formulating Hypotheses for Different Study Designs

Durga prasanna misra.

1 Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Armen Yuri Gasparyan

2 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Olena Zimba

3 Department of Internal Medicine #2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Marlen Yessirkepov

4 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Vikas Agarwal

George d. kitas.

5 Centre for Epidemiology versus Arthritis, University of Manchester, Manchester, UK.

Generating a testable working hypothesis is the first step towards conducting original research. Such research may prove or disprove the proposed hypothesis. Case reports, case series, online surveys and other observational studies, clinical trials, and narrative reviews help to generate hypotheses. Observational and interventional studies help to test hypotheses. A good hypothesis is usually based on previous evidence-based reports. Hypotheses without evidence-based justification and a priori ideas are not received favourably by the scientific community. Original research to test a hypothesis should be carefully planned to ensure appropriate methodology and adequate statistical power. While hypotheses can challenge conventional thinking and may be controversial, they should not be destructive. A hypothesis should be tested by ethically sound experiments with meaningful ethical and clinical implications. The coronavirus disease 2019 pandemic has brought into sharp focus numerous hypotheses, some of which were proven (e.g. effectiveness of corticosteroids in those with hypoxia) while others were disproven (e.g. ineffectiveness of hydroxychloroquine and ivermectin).

Graphical Abstract

DEFINING WORKING AND STANDALONE SCIENTIFIC HYPOTHESES

Science is the systematized description of natural truths and facts. Routine observations of existing life phenomena lead to the creative thinking and generation of ideas about mechanisms of such phenomena and related human interventions. Such ideas presented in a structured format can be viewed as hypotheses. After generating a hypothesis, it is necessary to test it to prove its validity. Thus, hypothesis can be defined as a proposed mechanism of a naturally occurring event or a proposed outcome of an intervention. 1 , 2

Hypothesis testing requires choosing the most appropriate methodology and adequately powering statistically the study to be able to “prove” or “disprove” it within predetermined and widely accepted levels of certainty. This entails sample size calculation that often takes into account previously published observations and pilot studies. 2 , 3 In the era of digitization, hypothesis generation and testing may benefit from the availability of numerous platforms for data dissemination, social networking, and expert validation. Related expert evaluations may reveal strengths and limitations of proposed ideas at early stages of post-publication promotion, preventing the implementation of unsupported controversial points. 4

Thus, hypothesis generation is an important initial step in the research workflow, reflecting accumulating evidence and experts' stance. In this article, we overview the genesis and importance of scientific hypotheses and their relevance in the era of the coronavirus disease 2019 (COVID-19) pandemic.

DO WE NEED HYPOTHESES FOR ALL STUDY DESIGNS?

Broadly, research can be categorized as primary or secondary. In the context of medicine, primary research may include real-life observations of disease presentations and outcomes. Single case descriptions, which often lead to new ideas and hypotheses, serve as important starting points or justifications for case series and cohort studies. The importance of case descriptions is particularly evident in the context of the COVID-19 pandemic when unique, educational case reports have heralded a new era in clinical medicine. 5

Case series serve similar purpose to single case reports, but are based on a slightly larger quantum of information. Observational studies, including online surveys, describe the existing phenomena at a larger scale, often involving various control groups. Observational studies include variable-scale epidemiological investigations at different time points. Interventional studies detail the results of therapeutic interventions.

Secondary research is based on already published literature and does not directly involve human or animal subjects. Review articles are generated by secondary research. These could be systematic reviews which follow methods akin to primary research but with the unit of study being published papers rather than humans or animals. Systematic reviews have a rigid structure with a mandatory search strategy encompassing multiple databases, systematic screening of search results against pre-defined inclusion and exclusion criteria, critical appraisal of study quality and an optional component of collating results across studies quantitatively to derive summary estimates (meta-analysis). 6 Narrative reviews, on the other hand, have a more flexible structure. Systematic literature searches to minimise bias in selection of articles are highly recommended but not mandatory. 7 Narrative reviews are influenced by the authors' viewpoint who may preferentially analyse selected sets of articles. 8

In relation to primary research, case studies and case series are generally not driven by a working hypothesis. Rather, they serve as a basis to generate a hypothesis. Observational or interventional studies should have a hypothesis for choosing research design and sample size. The results of observational and interventional studies further lead to the generation of new hypotheses, testing of which forms the basis of future studies. Review articles, on the other hand, may not be hypothesis-driven, but form fertile ground to generate future hypotheses for evaluation. Fig. 1 summarizes which type of studies are hypothesis-driven and which lead on to hypothesis generation.

STANDARDS OF WORKING AND SCIENTIFIC HYPOTHESES

A review of the published literature did not enable the identification of clearly defined standards for working and scientific hypotheses. It is essential to distinguish influential versus not influential hypotheses, evidence-based hypotheses versus a priori statements and ideas, ethical versus unethical, or potentially harmful ideas. The following points are proposed for consideration while generating working and scientific hypotheses. 1 , 2 Table 1 summarizes these points.

Evidence-based data

A scientific hypothesis should have a sound basis on previously published literature as well as the scientist's observations. Randomly generated (a priori) hypotheses are unlikely to be proven. A thorough literature search should form the basis of a hypothesis based on published evidence. 7

Unless a scientific hypothesis can be tested, it can neither be proven nor be disproven. Therefore, a scientific hypothesis should be amenable to testing with the available technologies and the present understanding of science.

Supported by pilot studies

If a hypothesis is based purely on a novel observation by the scientist in question, it should be grounded on some preliminary studies to support it. For example, if a drug that targets a specific cell population is hypothesized to be useful in a particular disease setting, then there must be some preliminary evidence that the specific cell population plays a role in driving that disease process.

Testable by ethical studies

The hypothesis should be testable by experiments that are ethically acceptable. 9 For example, a hypothesis that parachutes reduce mortality from falls from an airplane cannot be tested using a randomized controlled trial. 10 This is because it is obvious that all those jumping from a flying plane without a parachute would likely die. Similarly, the hypothesis that smoking tobacco causes lung cancer cannot be tested by a clinical trial that makes people take up smoking (since there is considerable evidence for the health hazards associated with smoking). Instead, long-term observational studies comparing outcomes in those who smoke and those who do not, as was performed in the landmark epidemiological case control study by Doll and Hill, 11 are more ethical and practical.

Balance between scientific temper and controversy

Novel findings, including novel hypotheses, particularly those that challenge established norms, are bound to face resistance for their wider acceptance. Such resistance is inevitable until the time such findings are proven with appropriate scientific rigor. However, hypotheses that generate controversy are generally unwelcome. For example, at the time the pandemic of human immunodeficiency virus (HIV) and AIDS was taking foot, there were numerous deniers that refused to believe that HIV caused AIDS. 12 , 13 Similarly, at a time when climate change is causing catastrophic changes to weather patterns worldwide, denial that climate change is occurring and consequent attempts to block climate change are certainly unwelcome. 14 The denialism and misinformation during the COVID-19 pandemic, including unfortunate examples of vaccine hesitancy, are more recent examples of controversial hypotheses not backed by science. 15 , 16 An example of a controversial hypothesis that was a revolutionary scientific breakthrough was the hypothesis put forth by Warren and Marshall that Helicobacter pylori causes peptic ulcers. Initially, the hypothesis that a microorganism could cause gastritis and gastric ulcers faced immense resistance. When the scientists that proposed the hypothesis themselves ingested H. pylori to induce gastritis in themselves, only then could they convince the wider world about their hypothesis. Such was the impact of the hypothesis was that Barry Marshall and Robin Warren were awarded the Nobel Prize in Physiology or Medicine in 2005 for this discovery. 17 , 18

DISTINGUISHING THE MOST INFLUENTIAL HYPOTHESES

Influential hypotheses are those that have stood the test of time. An archetype of an influential hypothesis is that proposed by Edward Jenner in the eighteenth century that cowpox infection protects against smallpox. While this observation had been reported for nearly a century before this time, it had not been suitably tested and publicised until Jenner conducted his experiments on a young boy by demonstrating protection against smallpox after inoculation with cowpox. 19 These experiments were the basis for widespread smallpox immunization strategies worldwide in the 20th century which resulted in the elimination of smallpox as a human disease today. 20

Other influential hypotheses are those which have been read and cited widely. An example of this is the hygiene hypothesis proposing an inverse relationship between infections in early life and allergies or autoimmunity in adulthood. An analysis reported that this hypothesis had been cited more than 3,000 times on Scopus. 1

LESSONS LEARNED FROM HYPOTHESES AMIDST THE COVID-19 PANDEMIC

The COVID-19 pandemic devastated the world like no other in recent memory. During this period, various hypotheses emerged, understandably so considering the public health emergency situation with innumerable deaths and suffering for humanity. Within weeks of the first reports of COVID-19, aberrant immune system activation was identified as a key driver of organ dysfunction and mortality in this disease. 21 Consequently, numerous drugs that suppress the immune system or abrogate the activation of the immune system were hypothesized to have a role in COVID-19. 22 One of the earliest drugs hypothesized to have a benefit was hydroxychloroquine. Hydroxychloroquine was proposed to interfere with Toll-like receptor activation and consequently ameliorate the aberrant immune system activation leading to pathology in COVID-19. 22 The drug was also hypothesized to have a prophylactic role in preventing infection or disease severity in COVID-19. It was also touted as a wonder drug for the disease by many prominent international figures. However, later studies which were well-designed randomized controlled trials failed to demonstrate any benefit of hydroxychloroquine in COVID-19. 23 , 24 , 25 , 26 Subsequently, azithromycin 27 , 28 and ivermectin 29 were hypothesized as potential therapies for COVID-19, but were not supported by evidence from randomized controlled trials. The role of vitamin D in preventing disease severity was also proposed, but has not been proven definitively until now. 30 , 31 On the other hand, randomized controlled trials identified the evidence supporting dexamethasone 32 and interleukin-6 pathway blockade with tocilizumab as effective therapies for COVID-19 in specific situations such as at the onset of hypoxia. 33 , 34 Clues towards the apparent effectiveness of various drugs against severe acute respiratory syndrome coronavirus 2 in vitro but their ineffectiveness in vivo have recently been identified. Many of these drugs are weak, lipophilic bases and some others induce phospholipidosis which results in apparent in vitro effectiveness due to non-specific off-target effects that are not replicated inside living systems. 35 , 36

Another hypothesis proposed was the association of the routine policy of vaccination with Bacillus Calmette-Guerin (BCG) with lower deaths due to COVID-19. This hypothesis emerged in the middle of 2020 when COVID-19 was still taking foot in many parts of the world. 37 , 38 Subsequently, many countries which had lower deaths at that time point went on to have higher numbers of mortality, comparable to other areas of the world. Furthermore, the hypothesis that BCG vaccination reduced COVID-19 mortality was a classic example of ecological fallacy. Associations between population level events (ecological studies; in this case, BCG vaccination and COVID-19 mortality) cannot be directly extrapolated to the individual level. Furthermore, such associations cannot per se be attributed as causal in nature, and can only serve to generate hypotheses that need to be tested at the individual level. 39

IS TRADITIONAL PEER REVIEW EFFICIENT FOR EVALUATION OF WORKING AND SCIENTIFIC HYPOTHESES?

Traditionally, publication after peer review has been considered the gold standard before any new idea finds acceptability amongst the scientific community. Getting a work (including a working or scientific hypothesis) reviewed by experts in the field before experiments are conducted to prove or disprove it helps to refine the idea further as well as improve the experiments planned to test the hypothesis. 40 A route towards this has been the emergence of journals dedicated to publishing hypotheses such as the Central Asian Journal of Medical Hypotheses and Ethics. 41 Another means of publishing hypotheses is through registered research protocols detailing the background, hypothesis, and methodology of a particular study. If such protocols are published after peer review, then the journal commits to publishing the completed study irrespective of whether the study hypothesis is proven or disproven. 42 In the post-pandemic world, online research methods such as online surveys powered via social media channels such as Twitter and Instagram might serve as critical tools to generate as well as to preliminarily test the appropriateness of hypotheses for further evaluation. 43 , 44

Some radical hypotheses might be difficult to publish after traditional peer review. These hypotheses might only be acceptable by the scientific community after they are tested in research studies. Preprints might be a way to disseminate such controversial and ground-breaking hypotheses. 45 However, scientists might prefer to keep their hypotheses confidential for the fear of plagiarism of ideas, avoiding online posting and publishing until they have tested the hypotheses.

SUGGESTIONS ON GENERATING AND PUBLISHING HYPOTHESES

Publication of hypotheses is important, however, a balance is required between scientific temper and controversy. Journal editors and reviewers might keep in mind these specific points, summarized in Table 2 and detailed hereafter, while judging the merit of hypotheses for publication. Keeping in mind the ethical principle of primum non nocere, a hypothesis should be published only if it is testable in a manner that is ethically appropriate. 46 Such hypotheses should be grounded in reality and lend themselves to further testing to either prove or disprove them. It must be considered that subsequent experiments to prove or disprove a hypothesis have an equal chance of failing or succeeding, akin to tossing a coin. A pre-conceived belief that a hypothesis is unlikely to be proven correct should not form the basis of rejection of such a hypothesis for publication. In this context, hypotheses generated after a thorough literature search to identify knowledge gaps or based on concrete clinical observations on a considerable number of patients (as opposed to random observations on a few patients) are more likely to be acceptable for publication by peer-reviewed journals. Also, hypotheses should be considered for publication or rejection based on their implications for science at large rather than whether the subsequent experiments to test them end up with results in favour of or against the original hypothesis.

Hypotheses form an important part of the scientific literature. The COVID-19 pandemic has reiterated the importance and relevance of hypotheses for dealing with public health emergencies and highlighted the need for evidence-based and ethical hypotheses. A good hypothesis is testable in a relevant study design, backed by preliminary evidence, and has positive ethical and clinical implications. General medical journals might consider publishing hypotheses as a specific article type to enable more rapid advancement of science.

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Data curation: Gasparyan AY, Misra DP, Zimba O, Yessirkepov M, Agarwal V, Kitas GD.

Reviewing the Literature, Developing a Hypothesis, Study Design

• First Online: 01 January 2011

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Rigorous research investigation requires a thorough review of the literature on the topic of interest. This promotes development of an original, relevant, and feasible hypothesis. Design of an optimal study to test the hypothesis then requires adequate power, freedom from bias, and conduct within a reasonable timeframe with resources available to the investigator.

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Meta-Analysis

A guide to appropriately planning and conducting meta-analyses—Part 1: indications, assumptions and understanding risk of bias

Meta-analysis and the science of research synthesis

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Acknowledgments

Financial Support: Indiana Genomics Initiative (INGEN) of Indiana University. INGEN is supported in part by Lilly Endowment Inc. (CMS).

I would like to thank Dr. Carl Schmidt, MD, MSCI, Assistant Professor Surgery, the Ohio State University, for his expertise and critical review of this chapter.

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Schmidt, C.M. (2011). Reviewing the Literature, Developing a Hypothesis, Study Design. In: Chen, H., Kao, L. (eds) Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-0-85729-313-8_3

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