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Empirical Research

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Emeka Thaddues Njoku 3

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The term “empirical” entails gathered data based on experience, observations, or experimentation. In empirical research, knowledge is developed from factual experience as opposed to theoretical assumption and usually involved the use of data sources like datasets or fieldwork, but can also be based on observations within a laboratory setting. Testing hypothesis or answering definite questions is a primary feature of empirical research. Empirical research, in other words, involves the process of employing working hypothesis that are tested through experimentation or observation. Hence, empirical research is a method of uncovering empirical evidence.

Through the process of gathering valid empirical data, scientists from a variety of fields, ranging from the social to the natural sciences, have to carefully design their methods. This helps to ensure quality and accuracy of data collection and treatment. However, any error in empirical data collection process could inevitably render such...

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Emeka Thaddues Njoku

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David A. Leeming

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Njoku, E.T. (2020). Empirical Research. In: Leeming, D.A. (eds) Encyclopedia of Psychology and Religion. Springer, Cham. https://doi.org/10.1007/978-3-030-24348-7_200051

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Research Guides

Empirical Research: Defining, Identifying, & Finding

Defining empirical research, what is empirical research, quantitative or qualitative.

Introduction
Database Tools
Search Terms
Image Descriptions

Calfee & Chambliss (2005) (UofM login required) describe empirical research as a "systematic approach for answering certain types of questions." Those questions are answered "[t]hrough the collection of evidence under carefully defined and replicable conditions" (p. 43).

The evidence collected during empirical research is often referred to as "data."

Characteristics of Empirical Research

Emerald Publishing's guide to conducting empirical research identifies a number of common elements to empirical research:

A research question , which will determine research objectives.
A particular and planned design for the research, which will depend on the question and which will find ways of answering it with appropriate use of resources.
The gathering of primary data , which is then analysed.
A particular methodology for collecting and analysing the data, such as an experiment or survey.
The limitation of the data to a particular group, area or time scale, known as a sample [emphasis added]: for example, a specific number of employees of a particular company type, or all users of a library over a given time scale. The sample should be somehow representative of a wider population.
The ability to recreate the study and test the results. This is known as reliability .
The ability to generalize from the findings to a larger sample and to other situations.

If you see these elements in a research article, you can feel confident that you have found empirical research. Emerald's guide goes into more detail on each element.

Empirical research methodologies can be described as quantitative, qualitative, or a mix of both (usually called mixed-methods).

Ruane (2016) (UofM login required) gets at the basic differences in approach between quantitative and qualitative research:

Quantitative research -- an approach to documenting reality that relies heavily on numbers both for the measurement of variables and for data analysis (p. 33).
Qualitative research -- an approach to documenting reality that relies on words and images as the primary data source (p. 33).

Both quantitative and qualitative methods are empirical . If you can recognize that a research study is quantitative or qualitative study, then you have also recognized that it is empirical study.

Below are information on the characteristics of quantitative and qualitative research. This video from Scribbr also offers a good overall introduction to the two approaches to research methodology:

Characteristics of Quantitative Research

Researchers test hypotheses, or theories, based in assumptions about causality, i.e. we expect variable X to cause variable Y. Variables have to be controlled as much as possible to ensure validity. The results explain the relationship between the variables. Measures are based in pre-defined instruments.

Examples: experimental or quasi-experimental design, pretest & post-test, survey or questionnaire with closed-ended questions. Studies that identify factors that influence an outcomes, the utility of an intervention, or understanding predictors of outcomes.

Characteristics of Qualitative Research

Researchers explore “meaning individuals or groups ascribe to social or human problems (Creswell & Creswell, 2018, p3).” Questions and procedures emerge rather than being prescribed. Complexity, nuance, and individual meaning are valued. Research is both inductive and deductive. Data sources are multiple and varied, i.e. interviews, observations, documents, photographs, etc. The researcher is a key instrument and must be reflective of their background, culture, and experiences as influential of the research.

Examples: open question interviews and surveys, focus groups, case studies, grounded theory, ethnography, discourse analysis, narrative, phenomenology, participatory action research.

Calfee, R. C. & Chambliss, M. (2005). The design of empirical research. In J. Flood, D. Lapp, J. R. Squire, & J. Jensen (Eds.), Methods of research on teaching the English language arts: The methodology chapters from the handbook of research on teaching the English language arts (pp. 43-78). Routledge. http://ezproxy.memphis.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=nlebk&AN=125955&site=eds-live&scope=site .

Creswell, J. W., & Creswell, J. D. (2018). Research design: Qualitative, quantitative, and mixed methods approaches (5th ed.). Thousand Oaks: Sage.

How to... conduct empirical research . (n.d.). Emerald Publishing. https://www.emeraldgrouppublishing.com/how-to/research-methods/conduct-empirical-research .

Scribbr. (2019). Quantitative vs. qualitative: The differences explained [video]. YouTube. https://www.youtube.com/watch?v=a-XtVF7Bofg .

Ruane, J. M. (2016). Introducing social research methods : Essentials for getting the edge . Wiley-Blackwell. http://ezproxy.memphis.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=nlebk&AN=1107215&site=eds-live&scope=site .

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Empirical research in the social sciences and education.

What is Empirical Research and How to Read It
Finding Empirical Research in Library Databases
Designing Empirical Research
Ethics, Cultural Responsiveness, and Anti-Racism in Research
Citing, Writing, and Presenting Your Work

Contact the Librarian at your campus for more help!

Introduction: What is Empirical Research?

Empirical research is based on observed and measured phenomena and derives knowledge from actual experience rather than from theory or belief.

How do you know if a study is empirical? Read the subheadings within the article, book, or report and look for a description of the research "methodology." Ask yourself: Could I recreate this study and test these results?

Key characteristics to look for:

Specific research questions to be answered
Definition of the population, behavior, or phenomena being studied
Description of the process used to study this population or phenomena, including selection criteria, controls, and testing instruments (such as surveys)

Another hint: some scholarly journals use a specific layout, called the "IMRaD" format, to communicate empirical research findings. Such articles typically have 4 components:

Introduction : sometimes called "literature review" -- what is currently known about the topic -- usually includes a theoretical framework and/or discussion of previous studies
Methodology: sometimes called "research design" -- how to recreate the study -- usually describes the population, research process, and analytical tools used in the present study
Results : sometimes called "findings" -- what was learned through the study -- usually appears as statistical data or as substantial quotations from research participants
Discussion : sometimes called "conclusion" or "implications" -- why the study is important -- usually describes how the research results influence professional practices or future studies

Reading and Evaluating Scholarly Materials

Reading research can be a challenge. However, the tutorials and videos below can help. They explain what scholarly articles look like, how to read them, and how to evaluate them:

CRAAP Checklist A frequently-used checklist that helps you examine the currency, relevance, authority, accuracy, and purpose of an information source.
IF I APPLY A newer model of evaluating sources which encourages you to think about your own biases as a reader, as well as concerns about the item you are reading.
Credo Video: How to Read Scholarly Materials (4 min.)
Credo Tutorial: How to Read Scholarly Materials
Credo Tutorial: Evaluating Information
Credo Video: Evaluating Statistics (4 min.)
Next: Finding Empirical Research in Library Databases >>
Last Updated: Feb 18, 2024 8:33 PM
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Identifying Empirical Research Articles

Identifying empirical articles.

Searching for Empirical Research Articles

What is Empirical Research?

An empirical research article reports the results of a study that uses data derived from actual observation or experimentation. Empirical research articles are examples of primary research. To learn more about the differences between primary and secondary research, see our related guide:

Primary and Secondary Sources

By the end of this guide, you will be able to:

Identify common elements of an empirical article
Use a variety of search strategies to search for empirical articles within the library collection

Look for the IMRaD layout in the article to help identify empirical research. Sometimes the sections will be labeled differently, but the content will be similar.

I ntroduction: why the article was written, research question or questions, hypothesis, literature review
M ethods: the overall research design and implementation, description of sample, instruments used, how the authors measured their experiment
R esults: output of the author's measurements, usually includes statistics of the author's findings
D iscussion: the author's interpretation and conclusions about the results, limitations of study, suggestions for further research

Parts of an Empirical Research Article

Parts of an empirical article.

The screenshots below identify the basic IMRaD structure of an empirical research article.

Introduction

The introduction contains a literature review and the study's research hypothesis.

The method section outlines the research design, participants, and measures used.

Results

The results section contains statistical data (charts, graphs, tables, etc.) and research participant quotes.

The discussion section includes impacts, limitations, future considerations, and research.

Learn the IMRaD Layout: How to Identify an Empirical Article

This short video overviews the IMRaD method for identifying empirical research.

Next: Searching for Empirical Research Articles >>
Last Updated: Nov 16, 2023 8:24 AM

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Introduction to Empirical Research

Databases for finding empirical research, guided search, google scholar, examples of empirical research, sources and further reading.

Interpretive Research
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Introductory Video This video covers what empirical research is, what kinds of questions and methods empirical researchers use, and some tips for finding empirical research articles in your discipline.

Guided Search: Finding Empirical Research Articles This is a hands-on tutorial that will allow you to use your own search terms to find resources.

Study on radiation transfer in human skin for cosmetics
Long-Term Mobile Phone Use and the Risk of Vestibular Schwannoma: A Danish Nationwide Cohort Study
Emissions Impacts and Benefits of Plug-In Hybrid Electric Vehicles and Vehicle-to-Grid Services
Review of design considerations and technological challenges for successful development and deployment of plug-in hybrid electric vehicles
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Empirical Research: Definition, Methods, Types and Examples

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Empirical research: Definition

Empirical research: origin, quantitative research methods, qualitative research methods, steps for conducting empirical research, empirical research methodology cycle, advantages of empirical research, disadvantages of empirical research, why is there a need for empirical research.

Empirical research is defined as any research where conclusions of the study is strictly drawn from concretely empirical evidence, and therefore “verifiable” evidence.

This empirical evidence can be gathered using quantitative market research and qualitative market research methods.

For example: A research is being conducted to find out if listening to happy music in the workplace while working may promote creativity? An experiment is conducted by using a music website survey on a set of audience who are exposed to happy music and another set who are not listening to music at all, and the subjects are then observed. The results derived from such a research will give empirical evidence if it does promote creativity or not.

LEARN ABOUT: Behavioral Research

You must have heard the quote” I will not believe it unless I see it”. This came from the ancient empiricists, a fundamental understanding that powered the emergence of medieval science during the renaissance period and laid the foundation of modern science, as we know it today. The word itself has its roots in greek. It is derived from the greek word empeirikos which means “experienced”.

In today’s world, the word empirical refers to collection of data using evidence that is collected through observation or experience or by using calibrated scientific instruments. All of the above origins have one thing in common which is dependence of observation and experiments to collect data and test them to come up with conclusions.

LEARN ABOUT: Causal Research

Types and methodologies of empirical research

Empirical research can be conducted and analysed using qualitative or quantitative methods.

Quantitative research : Quantitative research methods are used to gather information through numerical data. It is used to quantify opinions, behaviors or other defined variables . These are predetermined and are in a more structured format. Some of the commonly used methods are survey, longitudinal studies, polls, etc
Qualitative research: Qualitative research methods are used to gather non numerical data. It is used to find meanings, opinions, or the underlying reasons from its subjects. These methods are unstructured or semi structured. The sample size for such a research is usually small and it is a conversational type of method to provide more insight or in-depth information about the problem Some of the most popular forms of methods are focus groups, experiments, interviews, etc.

Data collected from these will need to be analysed. Empirical evidence can also be analysed either quantitatively and qualitatively. Using this, the researcher can answer empirical questions which have to be clearly defined and answerable with the findings he has got. The type of research design used will vary depending on the field in which it is going to be used. Many of them might choose to do a collective research involving quantitative and qualitative method to better answer questions which cannot be studied in a laboratory setting.

LEARN ABOUT: Qualitative Research Questions and Questionnaires

Quantitative research methods aid in analyzing the empirical evidence gathered. By using these a researcher can find out if his hypothesis is supported or not.

Survey research: Survey research generally involves a large audience to collect a large amount of data. This is a quantitative method having a predetermined set of closed questions which are pretty easy to answer. Because of the simplicity of such a method, high responses are achieved. It is one of the most commonly used methods for all kinds of research in today’s world.

Previously, surveys were taken face to face only with maybe a recorder. However, with advancement in technology and for ease, new mediums such as emails , or social media have emerged.

For example: Depletion of energy resources is a growing concern and hence there is a need for awareness about renewable energy. According to recent studies, fossil fuels still account for around 80% of energy consumption in the United States. Even though there is a rise in the use of green energy every year, there are certain parameters because of which the general population is still not opting for green energy. In order to understand why, a survey can be conducted to gather opinions of the general population about green energy and the factors that influence their choice of switching to renewable energy. Such a survey can help institutions or governing bodies to promote appropriate awareness and incentive schemes to push the use of greener energy.

Learn more: Renewable Energy Survey Template Descriptive Research vs Correlational Research

Experimental research: In experimental research , an experiment is set up and a hypothesis is tested by creating a situation in which one of the variable is manipulated. This is also used to check cause and effect. It is tested to see what happens to the independent variable if the other one is removed or altered. The process for such a method is usually proposing a hypothesis, experimenting on it, analyzing the findings and reporting the findings to understand if it supports the theory or not.

For example: A particular product company is trying to find what is the reason for them to not be able to capture the market. So the organisation makes changes in each one of the processes like manufacturing, marketing, sales and operations. Through the experiment they understand that sales training directly impacts the market coverage for their product. If the person is trained well, then the product will have better coverage.

Correlational research: Correlational research is used to find relation between two set of variables . Regression analysis is generally used to predict outcomes of such a method. It can be positive, negative or neutral correlation.

LEARN ABOUT: Level of Analysis

For example: Higher educated individuals will get higher paying jobs. This means higher education enables the individual to high paying job and less education will lead to lower paying jobs.

Longitudinal study: Longitudinal study is used to understand the traits or behavior of a subject under observation after repeatedly testing the subject over a period of time. Data collected from such a method can be qualitative or quantitative in nature.

For example: A research to find out benefits of exercise. The target is asked to exercise everyday for a particular period of time and the results show higher endurance, stamina, and muscle growth. This supports the fact that exercise benefits an individual body.

Cross sectional: Cross sectional study is an observational type of method, in which a set of audience is observed at a given point in time. In this type, the set of people are chosen in a fashion which depicts similarity in all the variables except the one which is being researched. This type does not enable the researcher to establish a cause and effect relationship as it is not observed for a continuous time period. It is majorly used by healthcare sector or the retail industry.

For example: A medical study to find the prevalence of under-nutrition disorders in kids of a given population. This will involve looking at a wide range of parameters like age, ethnicity, location, incomes and social backgrounds. If a significant number of kids coming from poor families show under-nutrition disorders, the researcher can further investigate into it. Usually a cross sectional study is followed by a longitudinal study to find out the exact reason.

Causal-Comparative research : This method is based on comparison. It is mainly used to find out cause-effect relationship between two variables or even multiple variables.

For example: A researcher measured the productivity of employees in a company which gave breaks to the employees during work and compared that to the employees of the company which did not give breaks at all.

LEARN ABOUT: Action Research

Some research questions need to be analysed qualitatively, as quantitative methods are not applicable there. In many cases, in-depth information is needed or a researcher may need to observe a target audience behavior, hence the results needed are in a descriptive analysis form. Qualitative research results will be descriptive rather than predictive. It enables the researcher to build or support theories for future potential quantitative research. In such a situation qualitative research methods are used to derive a conclusion to support the theory or hypothesis being studied.

LEARN ABOUT: Qualitative Interview

Case study: Case study method is used to find more information through carefully analyzing existing cases. It is very often used for business research or to gather empirical evidence for investigation purpose. It is a method to investigate a problem within its real life context through existing cases. The researcher has to carefully analyse making sure the parameter and variables in the existing case are the same as to the case that is being investigated. Using the findings from the case study, conclusions can be drawn regarding the topic that is being studied.

For example: A report mentioning the solution provided by a company to its client. The challenges they faced during initiation and deployment, the findings of the case and solutions they offered for the problems. Such case studies are used by most companies as it forms an empirical evidence for the company to promote in order to get more business.

Observational method: Observational method is a process to observe and gather data from its target. Since it is a qualitative method it is time consuming and very personal. It can be said that observational research method is a part of ethnographic research which is also used to gather empirical evidence. This is usually a qualitative form of research, however in some cases it can be quantitative as well depending on what is being studied.

For example: setting up a research to observe a particular animal in the rain-forests of amazon. Such a research usually take a lot of time as observation has to be done for a set amount of time to study patterns or behavior of the subject. Another example used widely nowadays is to observe people shopping in a mall to figure out buying behavior of consumers.

One-on-one interview: Such a method is purely qualitative and one of the most widely used. The reason being it enables a researcher get precise meaningful data if the right questions are asked. It is a conversational method where in-depth data can be gathered depending on where the conversation leads.

For example: A one-on-one interview with the finance minister to gather data on financial policies of the country and its implications on the public.

Focus groups: Focus groups are used when a researcher wants to find answers to why, what and how questions. A small group is generally chosen for such a method and it is not necessary to interact with the group in person. A moderator is generally needed in case the group is being addressed in person. This is widely used by product companies to collect data about their brands and the product.

For example: A mobile phone manufacturer wanting to have a feedback on the dimensions of one of their models which is yet to be launched. Such studies help the company meet the demand of the customer and position their model appropriately in the market.

Text analysis: Text analysis method is a little new compared to the other types. Such a method is used to analyse social life by going through images or words used by the individual. In today’s world, with social media playing a major part of everyone’s life, such a method enables the research to follow the pattern that relates to his study.

For example: A lot of companies ask for feedback from the customer in detail mentioning how satisfied are they with their customer support team. Such data enables the researcher to take appropriate decisions to make their support team better.

Sometimes a combination of the methods is also needed for some questions that cannot be answered using only one type of method especially when a researcher needs to gain a complete understanding of complex subject matter.

We recently published a blog that talks about examples of qualitative data in education ; why don’t you check it out for more ideas?

Since empirical research is based on observation and capturing experiences, it is important to plan the steps to conduct the experiment and how to analyse it. This will enable the researcher to resolve problems or obstacles which can occur during the experiment.

Step #1: Define the purpose of the research

This is the step where the researcher has to answer questions like what exactly do I want to find out? What is the problem statement? Are there any issues in terms of the availability of knowledge, data, time or resources. Will this research be more beneficial than what it will cost.

Before going ahead, a researcher has to clearly define his purpose for the research and set up a plan to carry out further tasks.

Step #2 : Supporting theories and relevant literature

The researcher needs to find out if there are theories which can be linked to his research problem . He has to figure out if any theory can help him support his findings. All kind of relevant literature will help the researcher to find if there are others who have researched this before, or what are the problems faced during this research. The researcher will also have to set up assumptions and also find out if there is any history regarding his research problem

Step #3: Creation of Hypothesis and measurement

Before beginning the actual research he needs to provide himself a working hypothesis or guess what will be the probable result. Researcher has to set up variables, decide the environment for the research and find out how can he relate between the variables.

Researcher will also need to define the units of measurements, tolerable degree for errors, and find out if the measurement chosen will be acceptable by others.

Step #4: Methodology, research design and data collection

In this step, the researcher has to define a strategy for conducting his research. He has to set up experiments to collect data which will enable him to propose the hypothesis. The researcher will decide whether he will need experimental or non experimental method for conducting the research. The type of research design will vary depending on the field in which the research is being conducted. Last but not the least, the researcher will have to find out parameters that will affect the validity of the research design. Data collection will need to be done by choosing appropriate samples depending on the research question. To carry out the research, he can use one of the many sampling techniques. Once data collection is complete, researcher will have empirical data which needs to be analysed.

LEARN ABOUT: Best Data Collection Tools

Step #5: Data Analysis and result

Data analysis can be done in two ways, qualitatively and quantitatively. Researcher will need to find out what qualitative method or quantitative method will be needed or will he need a combination of both. Depending on the unit of analysis of his data, he will know if his hypothesis is supported or rejected. Analyzing this data is the most important part to support his hypothesis.

Step #6: Conclusion

A report will need to be made with the findings of the research. The researcher can give the theories and literature that support his research. He can make suggestions or recommendations for further research on his topic.

A.D. de Groot, a famous dutch psychologist and a chess expert conducted some of the most notable experiments using chess in the 1940’s. During his study, he came up with a cycle which is consistent and now widely used to conduct empirical research. It consists of 5 phases with each phase being as important as the next one. The empirical cycle captures the process of coming up with hypothesis about how certain subjects work or behave and then testing these hypothesis against empirical data in a systematic and rigorous approach. It can be said that it characterizes the deductive approach to science. Following is the empirical cycle.

Observation: At this phase an idea is sparked for proposing a hypothesis. During this phase empirical data is gathered using observation. For example: a particular species of flower bloom in a different color only during a specific season.
Induction: Inductive reasoning is then carried out to form a general conclusion from the data gathered through observation. For example: As stated above it is observed that the species of flower blooms in a different color during a specific season. A researcher may ask a question “does the temperature in the season cause the color change in the flower?” He can assume that is the case, however it is a mere conjecture and hence an experiment needs to be set up to support this hypothesis. So he tags a few set of flowers kept at a different temperature and observes if they still change the color?
Deduction: This phase helps the researcher to deduce a conclusion out of his experiment. This has to be based on logic and rationality to come up with specific unbiased results.For example: In the experiment, if the tagged flowers in a different temperature environment do not change the color then it can be concluded that temperature plays a role in changing the color of the bloom.
Testing: This phase involves the researcher to return to empirical methods to put his hypothesis to the test. The researcher now needs to make sense of his data and hence needs to use statistical analysis plans to determine the temperature and bloom color relationship. If the researcher finds out that most flowers bloom a different color when exposed to the certain temperature and the others do not when the temperature is different, he has found support to his hypothesis. Please note this not proof but just a support to his hypothesis.
Evaluation: This phase is generally forgotten by most but is an important one to keep gaining knowledge. During this phase the researcher puts forth the data he has collected, the support argument and his conclusion. The researcher also states the limitations for the experiment and his hypothesis and suggests tips for others to pick it up and continue a more in-depth research for others in the future. LEARN MORE: Population vs Sample

LEARN MORE: Population vs Sample

There is a reason why empirical research is one of the most widely used method. There are a few advantages associated with it. Following are a few of them.

It is used to authenticate traditional research through various experiments and observations.
This research methodology makes the research being conducted more competent and authentic.
It enables a researcher understand the dynamic changes that can happen and change his strategy accordingly.
The level of control in such a research is high so the researcher can control multiple variables.
It plays a vital role in increasing internal validity .

Even though empirical research makes the research more competent and authentic, it does have a few disadvantages. Following are a few of them.

Such a research needs patience as it can be very time consuming. The researcher has to collect data from multiple sources and the parameters involved are quite a few, which will lead to a time consuming research.
Most of the time, a researcher will need to conduct research at different locations or in different environments, this can lead to an expensive affair.
There are a few rules in which experiments can be performed and hence permissions are needed. Many a times, it is very difficult to get certain permissions to carry out different methods of this research.
Collection of data can be a problem sometimes, as it has to be collected from a variety of sources through different methods.

LEARN ABOUT: Social Communication Questionnaire

Empirical research is important in today’s world because most people believe in something only that they can see, hear or experience. It is used to validate multiple hypothesis and increase human knowledge and continue doing it to keep advancing in various fields.

For example: Pharmaceutical companies use empirical research to try out a specific drug on controlled groups or random groups to study the effect and cause. This way, they prove certain theories they had proposed for the specific drug. Such research is very important as sometimes it can lead to finding a cure for a disease that has existed for many years. It is useful in science and many other fields like history, social sciences, business, etc.

LEARN ABOUT: 12 Best Tools for Researchers

With the advancement in today’s world, empirical research has become critical and a norm in many fields to support their hypothesis and gain more knowledge. The methods mentioned above are very useful for carrying out such research. However, a number of new methods will keep coming up as the nature of new investigative questions keeps getting unique or changing.

Create a single source of real data with a built-for-insights platform. Store past data, add nuggets of insights, and import research data from various sources into a CRM for insights. Build on ever-growing research with a real-time dashboard in a unified research management platform to turn insights into knowledge.

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Editorial: theory and empirical practice in research on social and emotional skills.

$\nMilo&#x; Kankara&#x;$

1 Organisation for Economic Co-Operation and Development, Paris, France
2 Department of Developmental, Personality and Social Psychology, Faculty of Psychology and Educational Sciences, Ghent University, Ghent, Belgium
3 Universidade São Francisco (USF), São Paulo, Brazil

Editorial on the Research Topic Theory and empirical practice in research on social and emotional skills

Introduction to the Research Topic

Social and emotional skills—also called non-cognitive skills, soft skills, character strengths, etc.—have drawn increasing attention from policymakers, practitioners and researchers over recent years. Our ability to manage our emotions, connect with others in a respectful and meaningful way, act responsively and understand and appreciate others' points of view are essential in successfully navigating our social worlds. The importance of these capacities was further amplified by several global trends that are fundamentally reshaping the social fabrics and interpersonal relationships. These include growing inter-connectivity, population diversity, complexity and variability of job requirements, the ever-accelerating pace of technological changes, the dismantling of old social networks, etc. The unprecedented social changes introduced by the COVID-19 pandemic have also shown the critical role these skills have in people's ability to adjust to new social and professional situations. With the expected continuation of current societal and technological trends, these skills will likely become even more pivotal in the future (hence they are sometimes also called “21st-century skills”).

Research on social and emotional skills is multi-disciplinary, combining a unique mix of academic and practice-oriented research approaches. It features both theoretical and empirical research streams, with lively discussions on the conceptual foundation and structure of these skills, their origin, development, malleability, and relevance. In this Research Topic, we have tried to reflect the diversity of the field's perspectives, disciplines, and methodological approaches and its unique blend of research and policy. The Research Topic contains empirical and theoretical works representing both streams of research on social and emotional skills. It also presents both academic and practice-oriented studies on a variety of topics in the field. Still, studies presented in this Research Topic place a particular emphasis on the issue of the application of gathered academic knowledge in educational settings. Selected studies do so either through examining current states, developing policy interventions, or evaluating their effectiveness.

Studies presented in this Research Topic examine the concept of social and emotional skills and their malleability and main determinants. The effectiveness of intervention programmes designed for the improvement of these skills is also analyzed. A particular emphasis is placed on the issue of the application of gathered knowledge in educational settings. Finally, several articles investigate the issue of valid and reliable assessment of these skills and the new developments in this aspect. Overall, the Research Topic offers a rich set of approaches, perspectives, methodologies and concepts examined and discussed by some of the leading researchers in the field. We hope that this Research Topic will contribute to the current discussions and developments in this lively field of research, offering new insights and ideas for further research.

Description of published articles

Improving classroom communication: the effects of virtual social training on communication and assertion skills in middle school students.

This article ( Johnson et al. ) focuses on one of the key policy premises regarding social and emotional skills—their potential to improve students' learning in academic settings. The study examined the possibility of improving educational processes and outcomes by training students' social and emotional skills. Findings showed that the use of the training in a virtual social environment could positively impact students' social confidence and behavior in the classroom. The special importance of this study is the possibility of successful training of social skills in an age group in which anxiety, social anxiety, and difficulties in interacting with peers develop very frequently. The involvement of teachers and innovative use of digital technologies are other promising aspects of this study.

Teaching socio-emotional competencies among primary school students

This is another study exploring the possibility of developing social and emotional skills in school settings through formal training programs ( Santamaría-Villar et al. ). Such studies are badly needed in this area as robust evaluations of intervention programs that aim developing students' social and emotional skills are still relatively scarce. Nevertheless, the study findings are positive, with the designed educational program leading to improvements in social behaviors of third-grade students, accompanied by improved awareness of aggressive behaviors in school and greater coexistence among students. Another important aspect of this study is that the intervention itself-−15 lessons in the form of school classes—is applicable and practical for a wide variety of school contexts.

Social, emotional, and behavioral skills: An integrative model of the skills associated with success during adolescence and across the life span

The authors of this paper offer a new, innovative and thought-provoking understanding of social and emotional skills and how they develop and correspond with various life outcomes. The article ( Napolitano et al. ) describes a new conceptualization of social, emotional, and behavioral skills outlined in an integrative model encompassing five related functioning domains. The paper discusses some of the key questions related to these concepts, such as their relations with personality traits, the distinction between maximum performance vs. typical performance perspective, skills' developmental trajectories and milestones, their practical importance, etc. One of the interesting features of the suggested model is that it includes only those skills that are found to be malleable throughout life, thus representing a very relevant framework from the policymaking point of view.

Toward a model of personality competencies underlying social and emotional skills: Insight from the circumplex of personality metatraits

This article ( Cieciuch and Strus ) offers an interesting and thorough theoretical analysis and conceptualization of social and emotional skills. The authors engage in an in-depth examination of various theoretical issues with no hesitation and with the required knowledge and expertise. Readers have a chance to familiarize themselves with a plethora of conceptual approaches and main issues in this area. Authors introduce their model and argue convincingly for the newly introduced theoretical solutions. Interested readers will have plenty of “food for thought” after reading this paper, hopefully inspiring them to examine some of its main postulates further.

Temperament and school readiness—A literature review

The meta-analytic reviews are a very useful and increasingly used approach in summarizing empirical findings in a particular area of research. In this article ( Potmesilova and Potmesil ), the authors employ the meta-analytic approach to discern whether temperamental characteristics (here defined through concepts of executive function, effortful control and self-regulation) of children are related to their school readiness. Based on a substantive sample of empirical studies, the authors find that both positive and negative emotionality influence school behavior of children (beneficially or adversely, respectively), especially their ability to focus and, consequently, their learning outcomes. Such findings place special importance on the quality of classroom environments, as discussed in the paper.

Age-specific life skills education in school: A systematic review

Life skill programs developed for adolescents may differ in both the targeted skills and the influencing factors on health and wellbeing they have as their focus ( Kirchhoff and Keller ). This review summarizes the impact of 18 evaluation studies published between 2007 and 2020. The review is timely and critical because, from a policy perspective, one needs to know what is the most sensitive period for particular skills to be promoted at schools, taking into account adolescents' biological and psychological development and changing environmental dynamics. Most programs start in Grades 5–6 or Grades 7–9, but the development of skills was only studied in a few programs, often demonstrating zero effects but also some positive findings. Objectives of health-oriented programs vary depending on student age. The review closes by identifying several research gaps to improve evidence-based work in this flourishing field.

Impacts of social and emotional learning interventions for teachers on teachers' outcomes: A systematic review with meta-analysis

The growing consideration for the development of students' social-emotional learning also directed the attention to teachers' social-emotional skills. Teachers' professional and personal functioning should be a top priority of policymakers, given the importance of teachers for students' academic achievement and the current dearth of teachers in the labor market due to many professionals leaving the job. This meta-analysis ( Oliveira et al. ) is the first to summarize social-emotional learning interventions reported in 43 empirical studies targeting the skills of teachers. Results are promising, showing small to medium effects of interventions on both teachers' skills and mental health outcomes. These results strongly encourage the implementation of such interventions in teacher training and development programs to strengthen teachers' personal and professional outcomes.

Equity in social emotional learning (SEL) programs: A content analysis of equitable practices in PreK-5 SEL programs

Although most social-emotional learning programs in education target the development of skills in students to foster collaboration and appreciation of diversity and cultural differences, this does not guarantee that the programs and their background, content and methods reflect the values and experiences of diverse populations. This review ( Ramirez et al. ) proposes a number of key perspectives that should form the basis and can be integrated into social-emotional learning and practice to align social-emotional learning and educational equity better. It is argued that social-emotional learning should be more than just an appreciation of diversity. It also involves a reciprocal process where diversity and equity affect the core of social-emotional learning programs questioning dominant and oppressing positions also aiming for social justice advocacy and positive identity development for all.

Formative assessment of social-emotional skills using rubrics: A review of knowns and unknowns

Social-emotional learning often involves the use of formative assessment tools to examine students' development of skills. Students' standing on various skills is often monitored using rubrics describing increasing levels of mastery of a skill. This paper ( Pancorbo et al. ) discusses the requirements for skill rubrics, reviews what we know and should know, and sketches a research agenda on how the reliability and validity of rubrics can be enhanced to better serve formative assessment of social-emotional learning in education.

SENNA inventory for the assessment of social and emotional skills in public school students in Brazil: Measuring both identity and self-efficacy

Although several inventories already exist to assess social-emotional skills in students, most reflect a specific model of social-emotional learning and are developed within Western cultures. The SENNA inventory, however, was developed to assess a comprehensive framework of social-emotional skills in students attending public schools in Brazil ( Primi et al. ). The inventory assesses skills from a dual perspective, i.e., “how well students can manifest a skill (self-efficacy)” and “how typically they use that skill” (identity). Psychometric data are reported from a large-scale assessment program in Brazil, and techniques to reduce answering tendencies are demonstrated to improve the reliability and structural validity of the assessments.

Two forms of social inequality in students' socio-emotional skills: Do the levels of big five personality traits and their associations with academic achievement depend on parental socioeconomic status?

It is common for policymakers to advocate developing socio-emotional skills to accelerate the learning of disadvantaged students. However, what empirical evidence supports these links between socio-economic status (SES), social and emotional skills and academic achievement? In this paper ( Lechner et al. ), the underlying assumptions of this argument are made explicit and testable, in a unique contribution to the field. The authors report that their empirical study provides little evidence of the link between social inequality and social and emotional skills, as well as of a differentiable relationship, that is, no evidence that social and emotional skills and achievement are strongly related among socially disadvantaged children. A causal relationship such as this would justify the development of social skills as a means to reduce inequality. Curiously the authors found the opposite effect (a slightly strong association between conscientiousness and achievement for students with high SES). It is an inspirational paper to the studies investigating the interplay between SES, social and emotional skills, and children's achievement.

To score or not to score? A simulation study on the performance of test scores, plausible values, and SEM, in regression with socio-emotional skill or personality scales as predictors

This paper makes an important methodological contribution to determining the correct statistical method to use when estimating factor scores when assessing social and emotional skills. Even though all techniques generate highly correlated scores, indicating that students' order on the skills should be roughly the same regardless of the technique used, the authors demonstrated that different methods are important in terms of criterion validity. That is because some methods suppress correlations with external criteria, which have important policy consequences. A unique feature of this study ( Bhaktha and Lechner ) is the systematic use of criterion validity for determining the psychometric quality of measures. Generally, this judgment is based on internal structural properties only (reliability and item loadings on the intended factor). The authors recommended Plausible Values or the Structural Equation Method among all the tested methods. This study hopefully will encourage programs to consider criterion validity as a systematic method for studying the psychometric properties of social and emotional skill assessments.

Making space for social and emotional learning in science education

With a practical perspective, this paper offers an original contribution based on a highly arousing experience of learning about arthropods in a biology curriculum. As entomologists and educators, the authors ask, “Can you imagine bringing a tarantula or a large insect into a classroom and students NOT having an emotional response? (p. 2). This study ( Ingram et al. ) aimed to test the integration of social-emotional learning into the STEM curriculum. The program intends to use the experience to promote social and emotional skills, such as empathy (fostering sympathy not only for the arthropods but for all people with a variety of experiences), self-reflection, self-management, etc. Additionally, it seeks to improve student engagement with STEM courses. Students' qualitative responses were analyzed before and after the program. The results demonstrated that students' emotional reactions shifted from negative to positive, and their engagement with the curriculum improved. Such findings are an interesting and creative demonstration that SEL can be incorporated into a diverse curriculum not commonly studied in the field of SEL.

Social and emotional learning in preschool settings: A systematic map of systematic reviews

A very important target of the development of social and emotional skills is achieved through early childhood education. This study ( Djamnezhad et al. ) aimed to identify high-quality systematic reviews of early childhood SEL interventions. Surprisingly, the authors found only two well-designed systematic reviews, leading to the critical conclusion that there are few reviews of SEL interventions in early education. In both reviews, the effect of universal SEL interventions was reported to positively impact several outcomes. However, because of methodological limitations, the authors recommend considering these results as tentative interpretations and suggest that this field is a knowledge gap. Hopefully, this study will encourage the development of sounding reviews of SEL interventions in early childhood.

Author contributions

All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Keywords: social and emotional skills, social and emotional learning (SEL), non-cognitive skills, skill development, school intervention programs, skill assessment, social and emotional behavior, 21st century skills

Citation: Kankaraš M, de Fruyt F and Primi R (2022) Editorial: Theory and empirical practice in research on social and emotional skills. Front. Educ. 7:993878. doi: 10.3389/feduc.2022.993878

Received: 14 July 2022; Accepted: 26 July 2022; Published: 11 August 2022.

Edited and reviewed by: Matteo Angelo Fabris , University of Turin, Italy

Copyright © 2022 Kankaraš, de Fruyt and Primi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Miloš Kankaraš, milos306@yahoo.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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A systematic review of empirical studies examining mechanisms of implementation in health

Affiliations.

1 Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, 98101, USA. [email protected].
2 Department of Psychological and Brain Sciences, Indiana University, 1101 E 10th Street, Bloomington, IN, 47405, USA. [email protected].
3 Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, 1959 NE Pacific Avenue, Seattle, WA, 98195, USA. [email protected].
4 Department of Psychology, University of California Los Angeles, 1177 Franz Hall, 502 Portola Plaza, Los Angeles, CA, 90095, USA.
5 Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA, 98101, USA.
6 Brown School, Washington University in St. Louis, 1 Brookings Drive, St. Louis, MO, 63130, USA.
7 Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, 1959 NE Pacific Avenue, Seattle, WA, 98195, USA.
8 Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104, USA.
9 Department of Research and Evaluation, Kaiser Permanente Southern California, 100 S Los Robles Avenue, Pasadena, CA, 91101, USA.
10 Department of Psychiatry, School of Medicine, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
11 Department of Health Services, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
12 Division of Cancer Control and Population Science, National Cancer Institute, 9609 Medical Center Drive, Rockville, MD, 20850, USA.
PMID: 32299461
PMCID: PMC7164241
DOI: 10.1186/s13012-020-00983-3

Background: Understanding the mechanisms of implementation strategies (i.e., the processes by which strategies produce desired effects) is important for research to understand why a strategy did or did not achieve its intended effect, and it is important for practice to ensure strategies are designed and selected to directly target determinants or barriers. This study is a systematic review to characterize how mechanisms are conceptualized and measured, how they are studied and evaluated, and how much evidence exists for specific mechanisms.

Methods: We systematically searched PubMed and CINAHL Plus for implementation studies published between January 1990 and August 2018 that included the terms "mechanism," "mediator," or "moderator." Two authors independently reviewed title and abstracts and then full texts for fit with our inclusion criteria of empirical studies of implementation in health care contexts. Authors extracted data regarding general study information, methods, results, and study design and mechanisms-specific information. Authors used the Mixed Methods Appraisal Tool to assess study quality.

Results: Search strategies produced 2277 articles, of which 183 were included for full text review. From these we included for data extraction 39 articles plus an additional seven articles were hand-entered from only other review of implementation mechanisms (total = 46 included articles). Most included studies employed quantitative methods (73.9%), while 10.9% were qualitative and 15.2% were mixed methods. Nine unique versions of models testing mechanisms emerged. Fifty-three percent of the studies met half or fewer of the quality indicators. The majority of studies (84.8%) only met three or fewer of the seven criteria stipulated for establishing mechanisms.

Conclusions: Researchers have undertaken a multitude of approaches to pursue mechanistic implementation research, but our review revealed substantive conceptual, methodological, and measurement issues that must be addressed in order to advance this critical research agenda. To move the field forward, there is need for greater precision to achieve conceptual clarity, attempts to generate testable hypotheses about how and why variables are related, and use of concrete behavioral indicators of proximal outcomes in the case of quantitative research and more directed inquiry in the case of qualitative research.

Keywords: Causal model; Determinant; Implementation; Mechanism; Mediator; Moderator; Theory.

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Can probiotics enhance fertility outcome? Capacity of probiotics as a single intervention to improve the feminine genital tract microbiota in non-symptomatic reproductive-aged women

Modifications in vaginal and endometrial microbiome and microbiota have been associated with fewer implantation rates and poorest pregnancy outcomes. Therefore, its study has emerged as a new biomarker in reproductive medicine. Despite the numerous papers published on probiotic use for vaginal dysbiosis and their actual wide empiric use especially for infertile patients, there is still no clear answer to justify their recommendation. The impact of probiotics on the vaginal or endometrial microbiota has often been investigated under a symptomatic altered vaginal microbial ecosystem, such as bacterial vaginosis. However 50% of women with bacterial vaginosis are asymptomatic. Actual clinical practice guidelines clearly recommend the use of specific antimicrobial agents for the management of symptomatic vaginal infections. Assuming this should be the management as well for an infertile population, what should be the treatment for the 50% non-symptomatic women presenting unfavorable vaginal/endometrial microbiota? The aim of this review is to assess the capacity of probiotics as a single intervention to alter the feminine genital tract microbiota in non-symptomatic reproductive-aged women.

1 Introduction

In the past two decades, great interest has emerged in the study of saprophytic microorganisms, especially since the advent of next-generation techniques based on PCR. In the gynecological field, it is well established that the female genital tract and more specifically the vagina accommodates its own microbiome, with approximately 9% of the total bacterial amount in the female body ( 1 ).

The terms microbiome and microbiota are commonly used indistinctively. However, microbiota is the collection of microorganisms coexisting in a particular site of the human body, while microbiome refers not only to microbes, but also to their genomes ( 2 ). There is a clear consensus on the fact than the vagina of healthy women of reproductive age is dominated by the Lactobacillus genus ( 3 ). Lactobacillus produces lactic acid, which then inhibits the growth of other bacteria and pathogens. When the equilibrium of this state changes, the term dysbiosis is applied, and it ranges from asymptomatic changes on the microbiome to symptomatic infectious diseases such as bacterial vaginosis (BV).

Modifications in vaginal and endometrial microbiome have been associated with gynecological consequences ( 4 ), worst reproductive outcomes ( 5 ), and infertility ( 6 ). Therefore, the study of the microbiome has emerged as a new biomarker in reproductive medicine.

When focusing on assisted reproductive technique (ART) outcomes, there seems to be a connection between abnormal vaginal microbiome and poorest pregnancy rate ( 7 ). Moreno et al. ( 6 ) have largely studied the endometrial microbiome in particular and conclude that non- Lactobacillus dominant microbiome (NLD, <90% of Lactobacillus spp. and >10% of other microbial taxa) is related to fewer implantation rates, less ongoing pregnancies, and reduced live births ( 8 ). In 2019, Koedooder et al. ( 9 ) developed a predictive model for reproductive outcome in women undergoing in vitro fertilization (IVF). They defined three different microbiota profiles according to which IVF success is predicted, in terms of achievable pregnancy rates ( 9 ).

A natural research question arising from this knowledge is whether vaginal and endometrial microbiome can be improved before undergoing ART by using a probiotic therapy rich in Lactobacillus . Despite the numerous papers published on probiotic use for vaginal dysbiosis and their actual wide empiric use, there is still no clear answer justifying their recommendation ( 10 ).

The impact of probiotics on the vaginal microbiota has often been investigated under a symptomatic altered vaginal microbial ecosystem, such as BV ( 11 ). It is known that BV affects 20%–50% of reproductive-aged women; however, 50% of women are asymptomatic ( 7 ).

Actual clinical practice guidelines clearly recommend the use of specific antimicrobial agents (antibiotic or antifungal) for the management of symptomatic vaginal infections ( 12 ). Assuming this should be the management as well for an infertile population, what should be the treatment for the 50% non-symptomatic women presenting unfavorable vaginal/endometrial microbiota? The aim of this review is to assess the capacity of probiotics as a single intervention to alter the feminine genital tract microbiota in non-symptomatic reproductive-aged women with or without infertility.

This systematic review has been elaborated following the PRISMA statement recommendations. A search of the literature published between 2002 and 2022 was performed in the PubMed database after establishing the following PICOS criteria:

Patient population or the disease being addressed: Not diseased women in reproductive age.
Interventions or exposure: Probiotics as a single treatment.
Comparator group: Placebo/absence of treatment.
Outcome or endpoint: Changes in vaginal/endometrial health parameters related to microbiota. Fertility outcomes.
Study design chosen: Clinical trials.

We searched for studies using the following terms: (microbio*” AND “fertility” AND “probiotic*”); (probiotics AND ivf); (probiotics AND embryo transfer); (“pregnancy rate” AND probiotics); (Conception AND probiotics); (“probiotics” AND infertility); (“microbio*” AND “infertility” AND “probiotic*”); (probiotic* and “endometrial microbiota”); (probiotic* and “vaginal microbiota”); (probiotic* and “vaginal microbiome”).

Article abstracts were screened, and all articles meeting the inclusion criteria were eligible for a full text assessment. References in the full text were also checked to identify further studies for inclusion.

Reasons for exclusion were as follows: articles containing no measurable endpoint on vaginal/endometrial health or fertility; publications without accessibility to the results; studies involving male partners; in vitro studies; pregnant and post-menopausal populations; interventions including antifungal/antibiotic treatments; studies on established diseased population (BV, vulvovaginal candidiasis, aerobic vaginitis, etc.); unpublished studies.

Information was extracted from each included trial on (i) characteristics of trial participants, (ii) method of diagnosis, (iii) type of study, (iv) site of studied microbiota, (v) size and description of the study groups, (vi) route, strain, dose, and duration of the probiotic intervention, (vii) safety, (viii) conflict of interest, (ix) objectives, and (x) outcomes.

This systematic review focused on discerning whether the exclusive use of probiotics can modify the vaginal or endometrial microbiota in women of reproductive age, especially in infertile patients. After initial investigation, only 13 of the 611 papers studied were finally included in this qualitative analysis ( Figure 1 ).

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Object name is fendo-13-1081830-g001.jpg

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram.

All 13 studies finally selected for the review were intervention studies with an intervention duration ranging between 2 days and 6 months. Eight out of 13 were randomized controlled trials with placebo and the rest were single-arm studies with no control group. The main results are presented in Table 1 .

Table 1

Characteristics of included studies. NS: Nugent score.

Disorder	Type	Size	Probiotics			Objective	Outcome/Clinical findings
			Route	Strain	Days
Healthy patients	Randomized, placebo-controlled trial	64	Oral	and	60	To determine safety and to test induced changes in pathogen load in the vagina.	Significant increase in vaginal lactobacilli at day 28 and day 60 for lactobacilli-treated subjects versus controls.
Infertile patients	Randomized	117	Vaginal		3	To investigate the effect of probiotics on vaginal colonization and on outcome of the IVF cycle.	Treatment does not affect the vaginal colonization of during oocyte retrieval or embryo transfer and does not improve the pregnancy rate.
Low lactobacilli or NS 4–6, pH >4.5	Single-arm interventional prospective study	37	Oral	, and	60	To assess the degree and persistence of colonization of the administered strains and its effect on vaginal health parameters.	Colonization is diverse among participants. No subject shows colonization before 10 days. Treatment lowers pH values and improves lactobacilli counting and NS.
Dysbiosis, NS 4–6, low lactobacilli number pH >4.5	Multicenter, randomized, blind, placebo-controlled trial	112	Vaginal	, and	7	To evaluate if the treatment could colonize and persist in the vagina and restore vaginal health parameters.	Intervention group experiences a significant reduction of vaginal pH and an increase in and . Both groups experience significant reduction of NS.
NS 0–6	A single-arm, pre–post study	35	Vaginal	s and	7	To evaluate if the treatment could colonize and persist in the vagina and restore vaginal health parameters.	50% of intermediate flora cases do not improve NS. Significant increase in the lactobacilli count but no significant changes in pH are detected.
NS 4–6	Double blind, randomized, placebo-controlled clinical trial	40	Oral	and	15	To assess the degree and persistence of the vaginal colonization and its effect on parameters of vaginal health and subjective symptoms.	NS is significantly improved compared to placebo after 15 days of treatment. Both strains increase significantly in the vagina in comparison to baseline.
Self-declared healthy women	Randomized double-blind placebo-controlled crossover trial	30	Oral		7	To evaluate safety and tolerability of the probiotic and monitor the impact on vaginal health parameters and lactobacilli counts in vagina and intestine.	Most of the changes are statistically non-significant; however, in vaginal samples, a reduction in is noted as well as a reduction of total bacterial count. Only one of the preparations results in a significant decrease of Nugent Score.
NS 4–6 and pH >4.5.	Interventional, double-blind controlled clinical trial	70	Oral	, and	60	To determine the effect of oral probiotic capsule on lactobacilli colonization and vaginal health parameters.	No significant difference in the average colonization of or PH before and during the intervention. However, NS significantly improves.
Healthy women	Randomized, blind, placebo-controlled trial	23	Oral		30	To assess the impact of probiotic on the vaginal microbiota composition and its ability to migrate to the vaginal mucosa.	The intervention does not appear to affect the stability of the vaginal CSTs; however, a significant reduction in the genus is observed.
Infertile women with	Prospective not randomized, not blinded	38	Oral		180	To assess the impact on vaginal parameters between women with reproductive failure and fertile women. To evaluate the ability of to increase pregnancy rates.	Detection of lactobacilli in the vaginal samples is higher in fertile women (100%) than in women with repetitive miscarriage (57%). Oral administration of leads to a relevant number of pregnancies in infertile population together with significant changes in vaginal health parameters.
Infertile women without acute BV	A prospective, monocentric randomized controlled trial	80	Oral	, and	30	To investigate the effect probiotic on vaginal microbiota.	Probiotics does not influence alpha or beta diversity of the vaginal microbiota. However, a significant difference in the abundance of between the probiotic group (lower) and the control group is noted.
Healthy women	Longitudinal study	16	Oral		60	To investigate whether probiotic had any impact on the vaginal microbiome and its functional potential.	The oral probiotic has no detectable effect on either the composition or the functional potential of the vaginal microbiota.
NS 4–6 or pH 4.5	Pilot, open-label efficacy study	36	Oral	, and	28–48	To investigate the clinical effects on vaginal health parameters.	Significant improvement of pH was observed in all groups. No significant improvement of NS.

Only two of the finally included studies assessed the use of probiotic therapy in infertile female participants ( 14 , 20 ). Fernández et al. ( 22 ) focused on women with a history of recurrent miscarriage ( n = 21, at least three or more pregnancy losses during the first 12 weeks of pregnancy) and ART failure ( n = 23, history of ART for at least three times, including two cycles of IVF). Patients were treated with oral L. salivarius for 6 months or until spontaneous pregnancy is achieved (without ART). According to their results, the intervention led to a 57% reproductive success, since 29 out of 44 treated patients got pregnant and 25 out of 44 were successful term pregnancies. Those achieving pregnancy after the intervention experienced significant changes in concentration of cultivable Lactobacillus , concentration of L. salivarius -specific DNA, pH, and Nugent Score. However, the low number of cases included and the absence of a control group using placebo within the infertile patient group are important limitations to be considered.

Despite the aforementioned inclusion criteria , none of the studies in this systematic review evaluated probiotic impact inendometrial microbiota. All the finally included studies focused on vaginalmicrobiota assessment.

Up to 11 different Lactobacillus strains were evaluated among the 13 studies, in solo or in different combinations. The most commonly assessed were L. gasseri and L. rhamnosus (five studies for each one), followed by L. acidophilus , L. fermentum , and L. plantarum (for studies for each one). Three studies evaluated L. paracasei and L. crispatus , whereas L. salivarius , L. jensenii , L. brevis , and L. reuteri were only studied in a single article.

Out of the four studies assessing L. acidophilus , three reported no significant changes in vaginal health parameters ( 14 , 20 , 25 ). Nevertheless, doses and duration of the probiotic treatments were too heterogeneous to get to solid conclusions. The other Lactobacillus strains presented contradictory data among the reviewed studies. Among the four studies evaluating L. fermentum , three reported positive outcomes in terms of vaginal presence or health parameters ( 13 , 15 , 16 ). Three studies precisely evaluated the combination of L. gasseri , L. fermentum , and L. plantarum ( 15 , 16 , 20 ), reaching different conclusions. The three of them evaluated Lactobacillus presence, pH, and Nugent Score. Tomusiak et al. ( 16 ) examined 160 women with intermediate vaginal microbiota according to Nugent Score ( 4 – 6 ), pH >4.5, and low or absent Lactobacillus count and divided them into two groups, one receiving the aforementioned vaginal probiotics and another group receiving a vaginal placebo for only 7 days. They found significant positive results in the intervention group regarding the three studied variables ( 16 ). On the other hand, Balaghi et al. ( 20 ) performed a similar study in 70 patients divided into two groups, one receiving an oral capsule of probiotics and a control group receiving placebo for 60 days. Results showed no significant differences in the Nugent Score, vaginal pH, or on Lactobacillus vaginal colonization ( 20 ). Strus et al. ( 15 ) also evaluated the oral delivery of the probiotics in 35 women for 60 days (with no control group). Nevertheless, they obtained contradictory results to the Balaghi et al. ( 20 ) study. They found colonization in majority of the participants after 30 days of treatment and significant reduction of pH and Nugent Score ( 15 ).

Regarding the diagnostic methods, the most commonly used were vaginal pH and Nugent Score. Only 7 out of 13 studies performed new molecular biology techniques.

Eleven out of 13 studies were conducted in European or European ascendant population; 7 out of 13 openly declared a conflict of interest, and 3 did not report such information. Only three reported total absence of disclosure.

4 Discussion

The debate regarding the use of probiotics in a population with asymptomatic dysbiosis before ART still has a long way to go. Although it is known that 50% of patients with dysbiosis are asymptomatic, the current insufficient evidence determines that neither empirical treatment with probiotics nor routine assessment of the vaginal/endometrial microbiota is recommended in this population. Currently, clinicians are only recommended to rule out the presence of clinical symptoms (smell, discharge, urinary tract infection, and candida) currently or during their menstrual cycle before undergoing IVF ( 10 ).

This systematic review demonstrates the difficulty in comparing studies due to the high level of heterogeneity in variables such as diagnostic method, strain used, or delivery method.

4.1 Lactobacillus strains

Assessing the possible beneficial effects of Lactobacillus genus on fertility seems no longer possible as a single question. Different Lactobacillus species have different characteristics such as the ability to produce lactic acid from degradation of glycogen conversion or capability to colonize vaginal or endometrial flora. Furthermore, their relative abundance among other species seems to play an important role too. Koedooder et al. ( 9 ) describe that a high abundance of Lactobacillus appears to be advantageous for IVF and IVF-ICSI outcome, but a high abundance (>60%) of specifically L. crispatus does not seem to be advantageous ( 9 ).

4.2 Delivery method

The aforementioned comparison among studies ( 15 , 16 , 20 ) raises the question if both delivery methods, oral or vaginal, work equally well. Tomusiak et al. ( 16 ) state that vaginally administered probiotics could have a quicker local action, driven by the activity of probiotic bacteria to colonize the vaginal epithelium, proving the efficient colonization of the abundance of L. plantarum and L. fermentum in the intervention group 100 times over versus the control group after 7 days ( 16 ). On the other hand, oral administration represents an advantage for the patient and is supposed to increase adherence to the treatment.

Most of the studies showing positive results after the treatment with Lactobacillus seem to agree on the fact that vaginal parameters seem to worsen once the exposition time is over. We could hypothesize then that exogen Lactobacillus may have difficulties in properly colonizing and replicating in the female tract epithelium.

4.3 Diagnostic methods

Currently, there is no gold standard in the assessment of vaginal dysbiosis ( 10 ) in the reproductive-aged population. Amsel criteria and Nugent score, the diagnostic methods classically used to detect BV, are insufficient to measure microbial complexity of the vaginal microbiota since they detect only a small number of organisms ( 26 ). Recently, the introduction of next-generation sequencing techniques has allowed complex microbiota communities to be better described, but the consensus on what threshold represents a healthy vaginal or endometrial microbiota has not yet been established.

4.4 Infertile population

When focusing on infertile population, only one study meets the inclusion criteria regarding the probiotic therapy as a single intervention ( 14 ). The current published data on infertile women are too heterogeneous to establish a valid diagnostic method or a treatment for vaginal dysbiosis. Two Japanese studies assessing endometrial microbiota on infertile population report pregnancy rates, but include heterogeneous concomitant antibiotic treatments for the dysbiotic profiles. Kyono et al. ( 27 ) found a higher clinical pregnancy rate in NLDM women treated with vaginal probiotics vs. no probiotics although not significant (58.8% vs. 48.0%, p = 0.47) ( 27 ). Kadogami et al. ( 28 ) studied 44 patients with recurrent implantation failure (RIF) and found that the therapeutic effects of the vaginal probiotic suppository seem to be higher than oral probiotics, prebiotics, and antibiotics together, except when Gardnerella is the main bacterium ( 28 ). In 2022, Engber ( 29 ) presents a randomized, double-blinded, placebo-controlled trial including 74 women referred for IVF. Microbiome profile is assessed using Koedooder et al.’s ( 9 ) classification ( 9 ), and they randomized patients with unfavorable vaginal microbiome to receive either vaginal probiotic capsules (containing >108 CFU of L. gasseri and >108 CFU of L. rhamnosus ) or placebo. They found no significant improvement in the vaginal microbiome between the two groups but they reported a spontaneous improvement rate of 34.2% over the period of 1 to 3 months after the treatment in both groups. This would mean that expectant management of vaginal dysbiosis can also be a strategy before IVF. One of the limitations of this study mentioned by the author is the fact that the study population is Caucasian. As described in this review, very few papers study the effects of probiotics in vaginal flora of ethnicities other than Caucasian. Since microbiota seems to be significantly different between ethnicities ( 3 ), the origin of the population should also be carefully described. Maybe probiotic therapy cannot be chosen from a one-size-fits-all point of view.

Studies in infertile populations represent an even bigger challenge for the scientific community. Endometrial dysbiosis can be the cause of implantation failure and lead to infertility ( 8 ). Nevertheless, uterine microbiota can be difficult to assess since endometrial microbiota samples need to be taken invasively and the contamination risk while introducing the catheter through the vagina is high.

Control on such variables and others such as type and moment of ovarian stimulation, fresh or frozen embryo transfer, euploidy of transferred embryos, and origin of the gametes needs to be taken into account in future studies.

4.5 Special considerations

As described in an interesting debate article by Buggio et al. ( 30 ), one should not forget that the probiotic market has shown an important growth in the past years while the media continues to present probiotics as an appealing solution for several health issues ( 30 ).

In our review, only three of the included articles openly declared absence of conflict of interest. Only a rigorous scientific approach should guide clinicians in the decision of whether to recommend probiotic therapy, and patients should be properly informed of the current scientific evidence on the subject.

5 Conclusions

According to what has been previously exposed, research on the effect of probiotics on vaginal and endometrial microbiome represents an important challenge for the scientific community. Lactobacillus -containing vaginal probiotics hold promise for vaginal/endometrial dysbiosis and have proven to be safe, but at the moment, scientific data are insufficient to recommend their use systematically for treating asymptomatic dysbiosis before IVF. In future studies, different probiotic strains, posology, and delivery methods should be separately and meticulously evaluated in well-defined populations. Nevertheless, the first and most important step towards standardization of care should be to establish accepted boundaries of what a healthy microbiota is and by which diagnostic tools it should be assessed. Otherwise, elucidating the relationship between the probiotic treatment and fertility will remain a difficult goal to achieve. In the meantime, more conservative strategies such as expectant management could be considered.

Author contributions

Both authors contributed equally in the review, the writing, and the submission of this paper.

Funding Statement

Fundación Ginefiv.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher’s note

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