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What is Observational Study Design and Types

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Most people think of a traditional experimental design when they consider research and published research papers. There is, however, a type of research that is more observational in nature, and it is appropriately referred to as “observational studies.”

There are many valuable reasons to utilize an observational study design. But, just as in research experimental design, different methods can be used when you’re considering this type of study. In this article, we’ll look at the advantages and disadvantages of an observational study design, as well as the 3 types of observational studies.

What is Observational Study Design?

An observational study is when researchers are looking at the effect of some type of intervention, risk, a diagnostic test or treatment, without trying to manipulate who is, or who isn’t, exposed to it.

This differs from an experimental study, where the scientists are manipulating who is exposed to the treatment, intervention, etc., by having a control group, or those who are not exposed, and an experimental group, or those who are exposed to the intervention, treatment, etc. In the best studies, the groups are randomized, or chosen by chance.

Any evidence derived from systematic reviews is considered the best in the hierarchy of evidence, which considers which studies are deemed the most reliable. Next would be any evidence that comes from randomized controlled trials. Cohort studies and case studies follow, in that order.

Cohort studies and case studies are considered observational in design, whereas the randomized controlled trial would be an experimental study.

Let’s take a closer look at the different types of observational study design.

The 3 types of Observational Studies

The different types of observational studies are used for different reasons. Selecting the best type for your research is critical to a successful outcome. One of the main reasons observational studies are used is when a randomized experiment would be considered unethical. For example, a life-saving medication used in a public health emergency. They are also used when looking at aetiology, or the cause of a condition or disease, as well as the treatment of rare conditions.

Case Control Observational Study

Researchers in case control studies identify individuals with an existing health issue or condition, or “cases,” along with a similar group without the condition, or “controls.” These two groups are then compared to identify predictors and outcomes. This type of study is helpful to generate a hypothesis that can then be researched.

Cohort Observational Study

This type of observational study is often used to help understand cause and effect. A cohort observational study looks at causes, incidence and prognosis, for example. A cohort is a group of people who are linked in a particular way, for example, a birth cohort would include people who were born within a specific period of time. Scientists might compare what happens to the members of the cohort who have been exposed to some variable to what occurs with members of the cohort who haven’t been exposed.

Cross Sectional Observational Study

Unlike a cohort observational study, a cross sectional observational study does not explore cause and effect, but instead looks at prevalence. Here you would look at data from a particular group at one very specific period of time. Researchers would simply observe and record information about something present in the population, without manipulating any variables or interventions. These types of studies are commonly used in psychology, education and social science.

Advantages and Disadvantages of Observational Study Design

Observational study designs have the distinct advantage of allowing researchers to explore answers to questions where a randomized controlled trial, or RCT, would be unethical. Additionally, if the study is focused on a rare condition, studying existing cases as compared to non-affected individuals might be the most effective way to identify possible causes of the condition. Likewise, if very little is known about a condition or circumstance, a cohort study would be a good study design choice.

A primary advantage to the observational study design is that they can generally be completed quickly and inexpensively. A RCT can take years before the data is compiled and available. RCTs are more complex and involved, requiring many more logistics and details to iron out, whereas an observational study can be more easily designed and completed.

The main disadvantage of observational study designs is that they’re more open to dispute than an RCT. Of particular concern would be confounding biases. This is when a cohort might share other characteristics that affect the outcome versus the outcome stated in the study. An example would be that people who practice good sleeping habits have less heart disease. But, maybe those who practice effective sleeping habits also, in general, eat better and exercise more.

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  • What Is an Observational Study? | Guide & Examples

What Is an Observational Study? | Guide & Examples

Published on 5 April 2022 by Tegan George . Revised on 20 March 2023.

An observational study is used to answer a research question based purely on what the researcher observes. There is no interference or manipulation of the research subjects, and no control and treatment groups .

These studies are often qualitative in nature and can be used for both exploratory and explanatory research purposes. While quantitative observational studies exist, they are less common.

Observational studies are generally used in hard science, medical, and social science fields. This is often due to ethical or practical concerns that prevent the researcher from conducting a traditional experiment . However, the lack of control and treatment groups means that forming inferences is difficult, and there is a risk of confounding variables impacting your analysis.

Table of contents

Types of observation, types of observational studies, observational study example, advantages and disadvantages of observational studies, observational study vs experiment, frequently asked questions.

There are many types of observation, and it can be challenging to tell the difference between them. Here are some of the most common types to help you choose the best one for your observational study.

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There are three main types of observational studies: cohort studies, case–control studies, and cross-sectional studies.

Cohort studies

Cohort studies are more longitudinal in nature, as they follow a group of participants over a period of time. Members of the cohort are selected because of a shared characteristic, such as smoking, and they are often observed over a period of years.

Case–control studies

Case–control studies bring together two groups, a case study group and a control group . The case study group has a particular attribute while the control group does not. The two groups are then compared, to see if the case group exhibits a particular characteristic more than the control group.

For example, if you compared smokers (the case study group) with non-smokers (the control group), you could observe whether the smokers had more instances of lung disease than the non-smokers.

Cross-sectional studies

Cross-sectional studies analyse a population of study at a specific point in time.

This often involves narrowing previously collected data to one point in time to test the prevalence of a theory—for example, analysing how many people were diagnosed with lung disease in March of a given year. It can also be a one-time observation, such as spending one day in the lung disease wing of a hospital.

Observational studies are usually quite straightforward to design and conduct. Sometimes all you need is a notebook and pen! As you design your study, you can follow these steps.

Step 1: Identify your research topic and objectives

The first step is to determine what you’re interested in observing and why. Observational studies are a great fit if you are unable to do an experiment for ethical or practical reasons, or if your research topic hinges on natural behaviors.

Step 2: Choose your observation type and technique

In terms of technique, there are a few things to consider:

  • Are you determining what you want to observe beforehand, or going in open-minded?
  • Is there another research method that would make sense in tandem with an observational study?
  • If yes, make sure you conduct a covert observation.
  • If not, think about whether observing from afar or actively participating in your observation is a better fit.
  • How can you preempt confounding variables that could impact your analysis?
  • You could observe the children playing at the playground in a naturalistic observation.
  • You could spend a month at a day care in your town conducting participant observation, immersing yourself in the day-to-day life of the children.
  • You could conduct covert observation behind a wall or glass, where the children can’t see you.

Overall, it is crucial to stay organised. Devise a shorthand for your notes, or perhaps design templates that you can fill in. Since these observations occur in real time, you won’t get a second chance with the same data.

Step 3: Set up your observational study

Before conducting your observations, there are a few things to attend to:

  • Plan ahead: If you’re interested in day cares, you’ll need to call a few in your area to plan a visit. They may not all allow observation, or consent from parents may be needed, so give yourself enough time to set everything up.
  • Determine your note-taking method: Observational studies often rely on note-taking because other methods, like video or audio recording, run the risk of changing participant behavior.
  • Get informed consent from your participants (or their parents) if you want to record:  Ultimately, even though it may make your analysis easier, the challenges posed by recording participants often make pen-and-paper a better choice.

Step 4: Conduct your observation

After you’ve chosen a type of observation, decided on your technique, and chosen a time and place, it’s time to conduct your observation.

Here, you can split them into case and control groups. The children with siblings have a characteristic you are interested in (siblings), while the children in the control group do not.

When conducting observational studies, be very careful of confounding or ‘lurking’ variables. In the example above, you observed children as they were dropped off, gauging whether or not they were upset. However, there are a variety of other factors that could be at play here (e.g., illness).

Step 5: Analyse your data

After you finish your observation, immediately record your initial thoughts and impressions, as well as follow-up questions or any issues you perceived during the observation. If you audio- or video-recorded your observations, you can transcribe them.

Your analysis can take an inductive or deductive approach :

  • If you conducted your observations in a more open-ended way, an inductive approach allows your data to determine your themes.
  • If you had specific hypotheses prior to conducting your observations, a deductive approach analyses whether your data confirm those themes or ideas you had previously.

Next, you can conduct your thematic or content analysis . Due to the open-ended nature of observational studies, the best fit is likely thematic analysis.

Step 6: Discuss avenues for future research

Observational studies are generally exploratory in nature, and they often aren’t strong enough to yield standalone conclusions due to their very high susceptibility to observer bias and confounding variables. For this reason, observational studies can only show association, not causation .

If you are excited about the preliminary conclusions you’ve drawn and wish to proceed with your topic, you may need to change to a different research method , such as an experiment.

  • Observational studies can provide information about difficult-to-analyse topics in a low-cost, efficient manner.
  • They allow you to study subjects that cannot be randomised safely, efficiently, or ethically .
  • They are often quite straightforward to conduct, since you just observe participant behavior as it happens or utilise preexisting data.
  • They’re often invaluable in informing later, larger-scale clinical trials or experiments.

Disadvantages

  • Observational studies struggle to stand on their own as a reliable research method. There is a high risk of observer bias and undetected confounding variables.
  • They lack conclusive results, typically are not externally valid or generalisable, and can usually only form a basis for further research.
  • They cannot make statements about the safety or efficacy of the intervention or treatment they study, only observe reactions to it. Therefore, they offer less satisfying results than other methods.

The key difference between observational studies and experiments is that a properly conducted observational study will never attempt to influence responses, while experimental designs by definition have some sort of treatment condition applied to a portion of participants.

However, there may be times when it’s impossible, dangerous, or impractical to influence the behavior of your participants. This can be the case in medical studies, where it is unethical or cruel to withhold potentially life-saving intervention, or in longitudinal analyses where you don’t have the ability to follow your group over the course of their lifetime.

An observational study may be the right fit for your research if random assignment of participants to control and treatment groups is impossible or highly difficult. However, the issues observational studies raise in terms of validity , confounding variables, and conclusiveness can mean that an experiment is more reliable.

If you’re able to randomise your participants safely and your research question is definitely causal in nature, consider using an experiment.

An observational study could be a good fit for your research if your research question is based on things you observe. If you have ethical, logistical, or practical concerns that make an experimental design challenging, consider an observational study. Remember that in an observational study, it is critical that there be no interference or manipulation of the research subjects. Since it’s not an experiment, there are no control or treatment groups either.

The key difference between observational studies and experiments is that, done correctly, an observational study will never influence the responses or behaviours of participants. Experimental designs will have a treatment condition applied to at least a portion of participants.

Exploratory research explores the main aspects of a new or barely researched question.

Explanatory research explains the causes and effects of an already widely researched question.

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

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

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Tegan George

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6.5 Observational Research

Learning objectives.

  • List the various types of observational research methods and distinguish between each
  • Describe the strengths and weakness of each observational research method. 

What Is Observational Research?

The term observational research is used to refer to several different types of non-experimental studies in which behavior is systematically observed and recorded. The goal of observational research is to describe a variable or set of variables. More generally, the goal is to obtain a snapshot of specific characteristics of an individual, group, or setting. As described previously, observational research is non-experimental because nothing is manipulated or controlled, and as such we cannot arrive at causal conclusions using this approach. The data that are collected in observational research studies are often qualitative in nature but they may also be quantitative or both (mixed-methods). There are several different types of observational research designs that will be described below.

Naturalistic Observation

Naturalistic observation  is an observational method that involves observing people’s behavior in the environment in which it typically occurs. Thus naturalistic observation is a type of field research (as opposed to a type of laboratory research). Jane Goodall’s famous research on chimpanzees is a classic example of naturalistic observation. Dr.  Goodall spent three decades observing chimpanzees in their natural environment in East Africa. She examined such things as chimpanzee’s social structure, mating patterns, gender roles, family structure, and care of offspring by observing them in the wild. However, naturalistic observation  could more simply involve observing shoppers in a grocery store, children on a school playground, or psychiatric inpatients in their wards. Researchers engaged in naturalistic observation usually make their observations as unobtrusively as possible so that participants are not aware that they are being studied. Such an approach is called disguised naturalistic observation.  Ethically, this method is considered to be acceptable if the participants remain anonymous and the behavior occurs in a public setting where people would not normally have an expectation of privacy. Grocery shoppers putting items into their shopping carts, for example, are engaged in public behavior that is easily observable by store employees and other shoppers. For this reason, most researchers would consider it ethically acceptable to observe them for a study. On the other hand, one of the arguments against the ethicality of the naturalistic observation of “bathroom behavior” discussed earlier in the book is that people have a reasonable expectation of privacy even in a public restroom and that this expectation was violated. 

In cases where it is not ethical or practical to conduct disguised naturalistic observation, researchers can conduct  undisguised naturalistic observation where the participants are made aware of the researcher presence and monitoring of their behavior. However, one concern with undisguised naturalistic observation is  reactivity. Reactivity  refers to when a measure changes participants’ behavior. In the case of undisguised naturalistic observation, the concern with reactivity is that when people know they are being observed and studied, they may act differently than they normally would. For instance, you may act much differently in a bar if you know that someone is observing you and recording your behaviors and this would invalidate the study. So disguised observation is less reactive and therefore can have higher validity because people are not aware that their behaviors are being observed and recorded. However, we now know that people often become used to being observed and with time they begin to behave naturally in the researcher’s presence. In other words, over time people habituate to being observed. Think about reality shows like Big Brother or Survivor where people are constantly being observed and recorded. While they may be on their best behavior at first, in a fairly short amount of time they are, flirting, having sex, wearing next to nothing, screaming at each other, and at times acting like complete fools in front of the entire nation.

Participant Observation

Another approach to data collection in observational research is participant observation. In  participant observation , researchers become active participants in the group or situation they are studying. Participant observation is very similar to naturalistic observation in that it involves observing people’s behavior in the environment in which it typically occurs. As with naturalistic observation, the data that is collected can include interviews (usually unstructured), notes based on their observations and interactions, documents, photographs, and other artifacts. The only difference between naturalistic observation and participant observation is that researchers engaged in participant observation become active members of the group or situations they are studying. The basic rationale for participant observation is that there may be important information that is only accessible to, or can be interpreted only by, someone who is an active participant in the group or situation. Like naturalistic observation, participant observation can be either disguised or undisguised. In disguised participant observation, the researchers pretend to be members of the social group they are observing and conceal their true identity as researchers. In contrast with undisguised participant observation,  the researchers become a part of the group they are studying and they disclose their true identity as researchers to the group under investigation. Once again there are important ethical issues to consider with disguised participant observation.  First no informed consent can be obtained and second passive deception is being used. The researcher is passively deceiving the participants by intentionally withholding information about their motivations for being a part of the social group they are studying. But sometimes disguised participation is the only way to access a protective group (like a cult). Further,  disguised participant observation is less prone to reactivity than undisguised participant observation. 

Rosenhan’s study (1973) [1]   of the experience of people in a psychiatric ward would be considered disguised participant observation because Rosenhan and his pseudopatients were admitted into psychiatric hospitals on the pretense of being patients so that they could observe the way that psychiatric patients are treated by staff. The staff and other patients were unaware of their true identities as researchers.

Another example of participant observation comes from a study by sociologist Amy Wilkins (published in  Social Psychology Quarterly ) on a university-based religious organization that emphasized how happy its members were (Wilkins, 2008) [2] . Wilkins spent 12 months attending and participating in the group’s meetings and social events, and she interviewed several group members. In her study, Wilkins identified several ways in which the group “enforced” happiness—for example, by continually talking about happiness, discouraging the expression of negative emotions, and using happiness as a way to distinguish themselves from other groups.

One of the primary benefits of participant observation is that the researcher is in a much better position to understand the viewpoint and experiences of the people they are studying when they are apart of the social group. The primary limitation with this approach is that the mere presence of the observer could affect the behavior of the people being observed. While this is also a concern with naturalistic observation when researchers because active members of the social group they are studying, additional concerns arise that they may change the social dynamics and/or influence the behavior of the people they are studying. Similarly, if the researcher acts as a participant observer there can be concerns with biases resulting from developing relationships with the participants. Concretely, the researcher may become less objective resulting in more experimenter bias.

Structured Observation

Another observational method is structured observation. Here the investigator makes careful observations of one or more specific behaviors in a particular setting that is more structured than the settings used in naturalistic and participant observation. Often the setting in which the observations are made is not the natural setting, rather the researcher may observe people in the laboratory environment. Alternatively, the researcher may observe people in a natural setting (like a classroom setting) that they have structured some way, for instance by introducing some specific task participants are to engage in or by introducing a specific social situation or manipulation. Structured observation is very similar to naturalistic observation and participant observation in that in all cases researchers are observing naturally occurring behavior, however, the emphasis in structured observation is on gathering quantitative rather than qualitative data. Researchers using this approach are interested in a limited set of behaviors. This allows them to quantify the behaviors they are observing. In other words, structured observation is less global than naturalistic and participant observation because the researcher engaged in structured observations is interested in a small number of specific behaviors. Therefore, rather than recording everything that happens, the researcher only focuses on very specific behaviors of interest.

Structured observation is very similar to naturalistic observation and participant observation in that in all cases researchers are observing naturally occurring behavior, however, the emphasis in structured observation is on gathering quantitative rather than qualitative data. Researchers using this approach are interested in a limited set of behaviors. This allows them to quantify the behaviors they are observing. In other words, structured observation is less global than naturalistic and participant observation because the researcher engaged in structured observations is interested in a small number of specific behaviors. Therefore, rather than recording everything that happens, the researcher only focuses on very specific behaviors of interest.

Researchers Robert Levine and Ara Norenzayan used structured observation to study differences in the “pace of life” across countries (Levine & Norenzayan, 1999) [3] . One of their measures involved observing pedestrians in a large city to see how long it took them to walk 60 feet. They found that people in some countries walked reliably faster than people in other countries. For example, people in Canada and Sweden covered 60 feet in just under 13 seconds on average, while people in Brazil and Romania took close to 17 seconds. When structured observation  takes place in the complex and even chaotic “real world,” the questions of when, where, and under what conditions the observations will be made, and who exactly will be observed are important to consider. Levine and Norenzayan described their sampling process as follows:

“Male and female walking speed over a distance of 60 feet was measured in at least two locations in main downtown areas in each city. Measurements were taken during main business hours on clear summer days. All locations were flat, unobstructed, had broad sidewalks, and were sufficiently uncrowded to allow pedestrians to move at potentially maximum speeds. To control for the effects of socializing, only pedestrians walking alone were used. Children, individuals with obvious physical handicaps, and window-shoppers were not timed. Thirty-five men and 35 women were timed in most cities.” (p. 186).  Precise specification of the sampling process in this way makes data collection manageable for the observers, and it also provides some control over important extraneous variables. For example, by making their observations on clear summer days in all countries, Levine and Norenzayan controlled for effects of the weather on people’s walking speeds.  In Levine and Norenzayan’s study, measurement was relatively straightforward. They simply measured out a 60-foot distance along a city sidewalk and then used a stopwatch to time participants as they walked over that distance.

As another example, researchers Robert Kraut and Robert Johnston wanted to study bowlers’ reactions to their shots, both when they were facing the pins and then when they turned toward their companions (Kraut & Johnston, 1979) [4] . But what “reactions” should they observe? Based on previous research and their own pilot testing, Kraut and Johnston created a list of reactions that included “closed smile,” “open smile,” “laugh,” “neutral face,” “look down,” “look away,” and “face cover” (covering one’s face with one’s hands). The observers committed this list to memory and then practiced by coding the reactions of bowlers who had been videotaped. During the actual study, the observers spoke into an audio recorder, describing the reactions they observed. Among the most interesting results of this study was that bowlers rarely smiled while they still faced the pins. They were much more likely to smile after they turned toward their companions, suggesting that smiling is not purely an expression of happiness but also a form of social communication.

When the observations require a judgment on the part of the observers—as in Kraut and Johnston’s study—this process is often described as  coding . Coding generally requires clearly defining a set of target behaviors. The observers then categorize participants individually in terms of which behavior they have engaged in and the number of times they engaged in each behavior. The observers might even record the duration of each behavior. The target behaviors must be defined in such a way that different observers code them in the same way. This difficulty with coding is the issue of interrater reliability, as mentioned in Chapter 4. Researchers are expected to demonstrate the interrater reliability of their coding procedure by having multiple raters code the same behaviors independently and then showing that the different observers are in close agreement. Kraut and Johnston, for example, video recorded a subset of their participants’ reactions and had two observers independently code them. The two observers showed that they agreed on the reactions that were exhibited 97% of the time, indicating good interrater reliability.

One of the primary benefits of structured observation is that it is far more efficient than naturalistic and participant observation. Since the researchers are focused on specific behaviors this reduces time and expense. Also, often times the environment is structured to encourage the behaviors of interested which again means that researchers do not have to invest as much time in waiting for the behaviors of interest to naturally occur. Finally, researchers using this approach can clearly exert greater control over the environment. However, when researchers exert more control over the environment it may make the environment less natural which decreases external validity. It is less clear for instance whether structured observations made in a laboratory environment will generalize to a real world environment. Furthermore, since researchers engaged in structured observation are often not disguised there may be more concerns with reactivity.

Case Studies

A  case study  is an in-depth examination of an individual. Sometimes case studies are also completed on social units (e.g., a cult) and events (e.g., a natural disaster). Most commonly in psychology, however, case studies provide a detailed description and analysis of an individual. Often the individual has a rare or unusual condition or disorder or has damage to a specific region of the brain.

Like many observational research methods, case studies tend to be more qualitative in nature. Case study methods involve an in-depth, and often a longitudinal examination of an individual. Depending on the focus of the case study, individuals may or may not be observed in their natural setting. If the natural setting is not what is of interest, then the individual may be brought into a therapist’s office or a researcher’s lab for study. Also, the bulk of the case study report will focus on in-depth descriptions of the person rather than on statistical analyses. With that said some quantitative data may also be included in the write-up of a case study. For instance, an individuals’ depression score may be compared to normative scores or their score before and after treatment may be compared. As with other qualitative methods, a variety of different methods and tools can be used to collect information on the case. For instance, interviews, naturalistic observation, structured observation, psychological testing (e.g., IQ test), and/or physiological measurements (e.g., brain scans) may be used to collect information on the individual.

HM is one of the most notorious case studies in psychology. HM suffered from intractable and very severe epilepsy. A surgeon localized HM’s epilepsy to his medial temporal lobe and in 1953 he removed large sections of his hippocampus in an attempt to stop the seizures. The treatment was a success, in that it resolved his epilepsy and his IQ and personality were unaffected. However, the doctors soon realized that HM exhibited a strange form of amnesia, called anterograde amnesia. HM was able to carry out a conversation and he could remember short strings of letters, digits, and words. Basically, his short term memory was preserved. However, HM could not commit new events to memory. He lost the ability to transfer information from his short-term memory to his long term memory, something memory researchers call consolidation. So while he could carry on a conversation with someone, he would completely forget the conversation after it ended. This was an extremely important case study for memory researchers because it suggested that there’s a dissociation between short-term memory and long-term memory, it suggested that these were two different abilities sub-served by different areas of the brain. It also suggested that the temporal lobes are particularly important for consolidating new information (i.e., for transferring information from short-term memory to long-term memory).

www.youtube.com/watch?v=KkaXNvzE4pk

The history of psychology is filled with influential cases studies, such as Sigmund Freud’s description of “Anna O.” (see Note 6.1 “The Case of “Anna O.””) and John Watson and Rosalie Rayner’s description of Little Albert (Watson & Rayner, 1920) [5] , who learned to fear a white rat—along with other furry objects—when the researchers made a loud noise while he was playing with the rat.

The Case of “Anna O.”

Sigmund Freud used the case of a young woman he called “Anna O.” to illustrate many principles of his theory of psychoanalysis (Freud, 1961) [6] . (Her real name was Bertha Pappenheim, and she was an early feminist who went on to make important contributions to the field of social work.) Anna had come to Freud’s colleague Josef Breuer around 1880 with a variety of odd physical and psychological symptoms. One of them was that for several weeks she was unable to drink any fluids. According to Freud,

She would take up the glass of water that she longed for, but as soon as it touched her lips she would push it away like someone suffering from hydrophobia.…She lived only on fruit, such as melons, etc., so as to lessen her tormenting thirst. (p. 9)

But according to Freud, a breakthrough came one day while Anna was under hypnosis.

[S]he grumbled about her English “lady-companion,” whom she did not care for, and went on to describe, with every sign of disgust, how she had once gone into this lady’s room and how her little dog—horrid creature!—had drunk out of a glass there. The patient had said nothing, as she had wanted to be polite. After giving further energetic expression to the anger she had held back, she asked for something to drink, drank a large quantity of water without any difficulty, and awoke from her hypnosis with the glass at her lips; and thereupon the disturbance vanished, never to return. (p.9)

Freud’s interpretation was that Anna had repressed the memory of this incident along with the emotion that it triggered and that this was what had caused her inability to drink. Furthermore, her recollection of the incident, along with her expression of the emotion she had repressed, caused the symptom to go away.

As an illustration of Freud’s theory, the case study of Anna O. is quite effective. As evidence for the theory, however, it is essentially worthless. The description provides no way of knowing whether Anna had really repressed the memory of the dog drinking from the glass, whether this repression had caused her inability to drink, or whether recalling this “trauma” relieved the symptom. It is also unclear from this case study how typical or atypical Anna’s experience was.

Figure 10.1 Anna O. “Anna O.” was the subject of a famous case study used by Freud to illustrate the principles of psychoanalysis. Source: http://en.wikipedia.org/wiki/File:Pappenheim_1882.jpg

Figure 10.1 Anna O. “Anna O.” was the subject of a famous case study used by Freud to illustrate the principles of psychoanalysis. Source: http://en.wikipedia.org/wiki/File:Pappenheim_1882.jpg

Case studies are useful because they provide a level of detailed analysis not found in many other research methods and greater insights may be gained from this more detailed analysis. As a result of the case study, the researcher may gain a sharpened understanding of what might become important to look at more extensively in future more controlled research. Case studies are also often the only way to study rare conditions because it may be impossible to find a large enough sample to individuals with the condition to use quantitative methods. Although at first glance a case study of a rare individual might seem to tell us little about ourselves, they often do provide insights into normal behavior. The case of HM provided important insights into the role of the hippocampus in memory consolidation. However, it is important to note that while case studies can provide insights into certain areas and variables to study, and can be useful in helping develop theories, they should never be used as evidence for theories. In other words, case studies can be used as inspiration to formulate theories and hypotheses, but those hypotheses and theories then need to be formally tested using more rigorous quantitative methods.

The reason case studies shouldn’t be used to provide support for theories is that they suffer from problems with internal and external validity. Case studies lack the proper controls that true experiments contain. As such they suffer from problems with internal validity, so they cannot be used to determine causation. For instance, during HM’s surgery, the surgeon may have accidentally lesioned another area of HM’s brain (indeed questioning into the possibility of a separate brain lesion began after HM’s death and dissection of his brain) and that lesion may have contributed to his inability to consolidate new information. The fact is, with case studies we cannot rule out these sorts of alternative explanations. So as with all observational methods case studies do not permit determination of causation. In addition, because case studies are often of a single individual, and typically a very abnormal individual, researchers cannot generalize their conclusions to other individuals. Recall that with most research designs there is a trade-off between internal and external validity, with case studies, however, there are problems with both internal validity and external validity. So there are limits both to the ability to determine causation and to generalize the results. A final limitation of case studies is that ample opportunity exists for the theoretical biases of the researcher to color or bias the case description. Indeed, there have been accusations that the woman who studied HM destroyed a lot of her data that were not published and she has been called into question for destroying contradictory data that didn’t support her theory about how memories are consolidated. There is a fascinating New York Times article that describes some of the controversies that ensued after HM’s death and analysis of his brain that can be found at: https://www.nytimes.com/2016/08/07/magazine/the-brain-that-couldnt-remember.html?_r=0

Archival Research

Another approach that is often considered observational research is the use of  archival research  which involves analyzing data that have already been collected for some other purpose. An example is a study by Brett Pelham and his colleagues on “implicit egotism”—the tendency for people to prefer people, places, and things that are similar to themselves (Pelham, Carvallo, & Jones, 2005) [7] . In one study, they examined Social Security records to show that women with the names Virginia, Georgia, Louise, and Florence were especially likely to have moved to the states of Virginia, Georgia, Louisiana, and Florida, respectively.

As with naturalistic observation, measurement can be more or less straightforward when working with archival data. For example, counting the number of people named Virginia who live in various states based on Social Security records is relatively straightforward. But consider a study by Christopher Peterson and his colleagues on the relationship between optimism and health using data that had been collected many years before for a study on adult development (Peterson, Seligman, & Vaillant, 1988) [8] . In the 1940s, healthy male college students had completed an open-ended questionnaire about difficult wartime experiences. In the late 1980s, Peterson and his colleagues reviewed the men’s questionnaire responses to obtain a measure of explanatory style—their habitual ways of explaining bad events that happen to them. More pessimistic people tend to blame themselves and expect long-term negative consequences that affect many aspects of their lives, while more optimistic people tend to blame outside forces and expect limited negative consequences. To obtain a measure of explanatory style for each participant, the researchers used a procedure in which all negative events mentioned in the questionnaire responses, and any causal explanations for them were identified and written on index cards. These were given to a separate group of raters who rated each explanation in terms of three separate dimensions of optimism-pessimism. These ratings were then averaged to produce an explanatory style score for each participant. The researchers then assessed the statistical relationship between the men’s explanatory style as undergraduate students and archival measures of their health at approximately 60 years of age. The primary result was that the more optimistic the men were as undergraduate students, the healthier they were as older men. Pearson’s  r  was +.25.

This method is an example of  content analysis —a family of systematic approaches to measurement using complex archival data. Just as structured observation requires specifying the behaviors of interest and then noting them as they occur, content analysis requires specifying keywords, phrases, or ideas and then finding all occurrences of them in the data. These occurrences can then be counted, timed (e.g., the amount of time devoted to entertainment topics on the nightly news show), or analyzed in a variety of other ways.

Key Takeaways

  • There are several different approaches to observational research including naturalistic observation, participant observation, structured observation, case studies, and archival research.
  • Naturalistic observation is used to observe people in their natural setting, participant observation involves becoming an active member of the group being observed, structured observation involves coding a small number of behaviors in a quantitative manner, case studies are typically used to collect in-depth information on a single individual, and archival research involves analysing existing data.
  • Describe one problem related to internal validity.
  • Describe one problem related to external validity.
  • Generate one hypothesis suggested by the case study that might be interesting to test in a systematic single-subject or group study.
  • Rosenhan, D. L. (1973). On being sane in insane places. Science, 179 , 250–258. ↵
  • Wilkins, A. (2008). “Happier than Non-Christians”: Collective emotions and symbolic boundaries among evangelical Christians. Social Psychology Quarterly, 71 , 281–301. ↵
  • Levine, R. V., & Norenzayan, A. (1999). The pace of life in 31 countries. Journal of Cross-Cultural Psychology, 30 , 178–205. ↵
  • Kraut, R. E., & Johnston, R. E. (1979). Social and emotional messages of smiling: An ethological approach. Journal of Personality and Social Psychology, 37 , 1539–1553. ↵
  • Watson, J. B., & Rayner, R. (1920). Conditioned emotional reactions. Journal of Experimental Psychology, 3 , 1–14. ↵
  • Freud, S. (1961).  Five lectures on psycho-analysis . New York, NY: Norton. ↵
  • Pelham, B. W., Carvallo, M., & Jones, J. T. (2005). Implicit egotism. Current Directions in Psychological Science, 14 , 106–110. ↵
  • Peterson, C., Seligman, M. E. P., & Vaillant, G. E. (1988). Pessimistic explanatory style is a risk factor for physical illness: A thirty-five year longitudinal study. Journal of Personality and Social Psychology, 55 , 23–27. ↵

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  • What Is a Research Design | Types, Guide & Examples

What Is a Research Design | Types, Guide & Examples

Published on June 7, 2021 by Shona McCombes . Revised on November 20, 2023 by Pritha Bhandari.

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

  • Your overall research objectives and approach
  • Whether you’ll rely on primary research or secondary research
  • Your sampling methods or criteria for selecting subjects
  • Your data collection methods
  • The procedures you’ll follow to collect data
  • Your data analysis methods

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

Table of contents

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

  • Introduction

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

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

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

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

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

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

Practical and ethical considerations when designing research

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

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

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

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

Types of quantitative research designs

Quantitative designs can be split into four main types.

  • Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships
  • Descriptive and correlational designs allow you to measure variables and describe relationships between them.

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

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

Types of qualitative research designs

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

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

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

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

Defining the population

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

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

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

  • Sampling methods

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

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

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

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

Case selection in qualitative research

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

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

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

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

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

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

Survey methods

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

Observation methods

Observational studies allow you to collect data unobtrusively, observing characteristics, behaviors or social interactions without relying on self-reporting.

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

Other methods of data collection

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

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

Secondary data

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

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

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

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

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

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

Operationalization

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

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

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

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

Reliability and validity

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

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

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

Sampling procedures

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

That means making decisions about things like:

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

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

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

Data management

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

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

Keeping your data well-organized will save time when it comes to analyzing it. It can also help other researchers validate and add to your findings (high replicability ).

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

Quantitative data analysis

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

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

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

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

Using inferential statistics , you can:

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

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

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

Qualitative data analysis

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

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

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

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.

  • 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

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

Quantitative research designs can be divided into two main categories:

  • Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
  • Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

The priorities of a research design can vary depending on the field, but you usually have to specify:

  • Your research questions and/or hypotheses
  • Your overall approach (e.g., qualitative or quantitative )
  • The type of design you’re using (e.g., a survey , experiment , or case study )
  • Your data collection methods (e.g., questionnaires , observations)
  • Your data collection procedures (e.g., operationalization , timing and data management)
  • Your data analysis methods (e.g., statistical tests  or thematic analysis )

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Operationalization means turning abstract conceptual ideas into measurable observations.

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

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

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

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An introduction to different types of study design

Posted on 6th April 2021 by Hadi Abbas

""

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

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

Descriptive studies

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

Analytical Studies

Analytical studies are of 2 types: observational and experimental.

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

Observational studies

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

Cross-sectional study:

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

Cohort study:

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

Case-Control Study:

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

Experimental Studies

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

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

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

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

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

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

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

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

References (pdf)

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

An introduction to randomized controlled trials

Case-control and cohort studies: a brief overview

Cohort studies: prospective and retrospective designs

Prevalence vs Incidence: what is the difference?

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

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Very informative and easy understandable

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

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Wow very erll explained and easy to understand

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

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well understood,thank you so much

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Well understood…thanks

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Simply explained. Thank You.

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

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

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it is very informative and useful.

thank you statistician

Fabulous to hear, thank you John.

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Thanks for this information

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

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

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

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

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

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

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

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

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

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

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Cluster Randomized Trials: Concepts

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Expertise-based Randomized Controlled Trials

This blog summarizes the concepts of Expertise-based randomized controlled trials with a focus on the advantages and challenges associated with this type of study.

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Understanding Clinical Research

Chapter 12. Observational Study Designs

Bradley G. Hammill

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Observational studies in clinical research can be classified as either analytic or descriptive ( Table 12–1 ). Analytic observational studies are similar to randomized, controlled clinical trials in that the goal is to estimate the causal effect of an exposure on an outcome. Also similar to trials, analytic observational studies always include some type of comparison group, against which the experience of the exposed group is compared. Well-designed analytic studies can generate strong evidence for or against a stated hypothesis. Descriptive studies, on the other hand, aim to describe the characteristics or experiences of a particular patient group. Even well-designed descriptive studies cannot be used to draw strong conclusions about the effect of an exposure on an outcome. Instead, these studies are often used to generate study questions that can then be tested by more rigorous methods.

Although many observational study designs are available to researchers ( 1 ), a few are most widely used and will be described below. The analytic study designs presented are the case-control study and the cohort study. The descriptive study designs presented are the ecologic study, the cross-sectional prevalence survey, and case reports or case series.

Case-Control Studies

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Research Method

Home » Observational Research – Methods and Guide

Observational Research – Methods and Guide

Table of Contents

Observational Research

Observational Research

Definition:

Observational research is a type of research method where the researcher observes and records the behavior of individuals or groups in their natural environment. In other words, the researcher does not intervene or manipulate any variables but simply observes and describes what is happening.

Observation

Observation is the process of collecting and recording data by observing and noting events, behaviors, or phenomena in a systematic and objective manner. It is a fundamental method used in research, scientific inquiry, and everyday life to gain an understanding of the world around us.

Types of Observational Research

Observational research can be categorized into different types based on the level of control and the degree of involvement of the researcher in the study. Some of the common types of observational research are:

Naturalistic Observation

In naturalistic observation, the researcher observes and records the behavior of individuals or groups in their natural environment without any interference or manipulation of variables.

Controlled Observation

In controlled observation, the researcher controls the environment in which the observation is taking place. This type of observation is often used in laboratory settings.

Participant Observation

In participant observation, the researcher becomes an active participant in the group or situation being observed. The researcher may interact with the individuals being observed and gather data on their behavior, attitudes, and experiences.

Structured Observation

In structured observation, the researcher defines a set of behaviors or events to be observed and records their occurrence.

Unstructured Observation

In unstructured observation, the researcher observes and records any behaviors or events that occur without predetermined categories.

Cross-Sectional Observation

In cross-sectional observation, the researcher observes and records the behavior of different individuals or groups at a single point in time.

Longitudinal Observation

In longitudinal observation, the researcher observes and records the behavior of the same individuals or groups over an extended period of time.

Data Collection Methods

Observational research uses various data collection methods to gather information about the behaviors and experiences of individuals or groups being observed. Some common data collection methods used in observational research include:

Field Notes

This method involves recording detailed notes of the observed behavior, events, and interactions. These notes are usually written in real-time during the observation process.

Audio and Video Recordings

Audio and video recordings can be used to capture the observed behavior and interactions. These recordings can be later analyzed to extract relevant information.

Surveys and Questionnaires

Surveys and questionnaires can be used to gather additional information from the individuals or groups being observed. This method can be used to validate or supplement the observational data.

Time Sampling

This method involves taking a snapshot of the observed behavior at pre-determined time intervals. This method helps to identify the frequency and duration of the observed behavior.

Event Sampling

This method involves recording specific events or behaviors that are of interest to the researcher. This method helps to provide detailed information about specific behaviors or events.

Checklists and Rating Scales

Checklists and rating scales can be used to record the occurrence and frequency of specific behaviors or events. This method helps to simplify and standardize the data collection process.

Observational Data Analysis Methods

Observational Data Analysis Methods are:

Descriptive Statistics

This method involves using statistical techniques such as frequency distributions, means, and standard deviations to summarize the observed behaviors, events, or interactions.

Qualitative Analysis

Qualitative analysis involves identifying patterns and themes in the observed behaviors or interactions. This analysis can be done manually or with the help of software tools.

Content Analysis

Content analysis involves categorizing and counting the occurrences of specific behaviors or events. This analysis can be done manually or with the help of software tools.

Time-series Analysis

Time-series analysis involves analyzing the changes in behavior or interactions over time. This analysis can help identify trends and patterns in the observed data.

Inter-observer Reliability Analysis

Inter-observer reliability analysis involves comparing the observations made by multiple observers to ensure the consistency and reliability of the data.

Multivariate Analysis

Multivariate analysis involves analyzing multiple variables simultaneously to identify the relationships between the observed behaviors, events, or interactions.

Event Coding

This method involves coding observed behaviors or events into specific categories and then analyzing the frequency and duration of each category.

Cluster Analysis

Cluster analysis involves grouping similar behaviors or events into clusters based on their characteristics or patterns.

Latent Class Analysis

Latent class analysis involves identifying subgroups of individuals or groups based on their observed behaviors or interactions.

Social network Analysis

Social network analysis involves mapping the social relationships and interactions between individuals or groups based on their observed behaviors.

The choice of data analysis method depends on the research question, the type of data collected, and the available resources. Researchers should choose the appropriate method that best fits their research question and objectives. It is also important to ensure the validity and reliability of the data analysis by using appropriate statistical tests and measures.

Applications of Observational Research

Observational research is a versatile research method that can be used in a variety of fields to explore and understand human behavior, attitudes, and preferences. Here are some common applications of observational research:

  • Psychology : Observational research is commonly used in psychology to study human behavior in natural settings. This can include observing children at play to understand their social development or observing people’s reactions to stress to better understand how stress affects behavior.
  • Marketing : Observational research is used in marketing to understand consumer behavior and preferences. This can include observing shoppers in stores to understand how they make purchase decisions or observing how people interact with advertisements to determine their effectiveness.
  • Education : Observational research is used in education to study teaching and learning in natural settings. This can include observing classrooms to understand how teachers interact with students or observing students to understand how they learn.
  • Anthropology : Observational research is commonly used in anthropology to understand cultural practices and beliefs. This can include observing people’s daily routines to understand their culture or observing rituals and ceremonies to better understand their significance.
  • Healthcare : Observational research is used in healthcare to understand patient behavior and preferences. This can include observing patients in hospitals to understand how they interact with healthcare professionals or observing patients with chronic illnesses to better understand their daily routines and needs.
  • Sociology : Observational research is used in sociology to understand social interactions and relationships. This can include observing people in public spaces to understand how they interact with others or observing groups to understand how they function.
  • Ecology : Observational research is used in ecology to understand the behavior and interactions of animals and plants in their natural habitats. This can include observing animal behavior to understand their social structures or observing plant growth to understand their response to environmental factors.
  • Criminology : Observational research is used in criminology to understand criminal behavior and the factors that contribute to it. This can include observing criminal activity in a particular area to identify patterns or observing the behavior of inmates to understand their experience in the criminal justice system.

Observational Research Examples

Here are some real-time observational research examples:

  • A researcher observes and records the behaviors of a group of children on a playground to study their social interactions and play patterns.
  • A researcher observes the buying behaviors of customers in a retail store to study the impact of store layout and product placement on purchase decisions.
  • A researcher observes the behavior of drivers at a busy intersection to study the effectiveness of traffic signs and signals.
  • A researcher observes the behavior of patients in a hospital to study the impact of staff communication and interaction on patient satisfaction and recovery.
  • A researcher observes the behavior of employees in a workplace to study the impact of the work environment on productivity and job satisfaction.
  • A researcher observes the behavior of shoppers in a mall to study the impact of music and lighting on consumer behavior.
  • A researcher observes the behavior of animals in their natural habitat to study their social and feeding behaviors.
  • A researcher observes the behavior of students in a classroom to study the effectiveness of teaching methods and student engagement.
  • A researcher observes the behavior of pedestrians and cyclists on a city street to study the impact of infrastructure and traffic regulations on safety.

How to Conduct Observational Research

Here are some general steps for conducting Observational Research:

  • Define the Research Question: Determine the research question and objectives to guide the observational research study. The research question should be specific, clear, and relevant to the area of study.
  • Choose the appropriate observational method: Choose the appropriate observational method based on the research question, the type of data required, and the available resources.
  • Plan the observation: Plan the observation by selecting the observation location, duration, and sampling technique. Identify the population or sample to be observed and the characteristics to be recorded.
  • Train observers: Train the observers on the observational method, data collection tools, and techniques. Ensure that the observers understand the research question and objectives and can accurately record the observed behaviors or events.
  • Conduct the observation : Conduct the observation by recording the observed behaviors or events using the data collection tools and techniques. Ensure that the observation is conducted in a consistent and unbiased manner.
  • Analyze the data: Analyze the observed data using appropriate data analysis methods such as descriptive statistics, qualitative analysis, or content analysis. Validate the data by checking the inter-observer reliability and conducting statistical tests.
  • Interpret the results: Interpret the results by answering the research question and objectives. Identify the patterns, trends, or relationships in the observed data and draw conclusions based on the analysis.
  • Report the findings: Report the findings in a clear and concise manner, using appropriate visual aids and tables. Discuss the implications of the results and the limitations of the study.

When to use Observational Research

Here are some situations where observational research can be useful:

  • Exploratory Research: Observational research can be used in exploratory studies to gain insights into new phenomena or areas of interest.
  • Hypothesis Generation: Observational research can be used to generate hypotheses about the relationships between variables, which can be tested using experimental research.
  • Naturalistic Settings: Observational research is useful in naturalistic settings where it is difficult or unethical to manipulate the environment or variables.
  • Human Behavior: Observational research is useful in studying human behavior, such as social interactions, decision-making, and communication patterns.
  • Animal Behavior: Observational research is useful in studying animal behavior in their natural habitats, such as social and feeding behaviors.
  • Longitudinal Studies: Observational research can be used in longitudinal studies to observe changes in behavior over time.
  • Ethical Considerations: Observational research can be used in situations where manipulating the environment or variables would be unethical or impractical.

Purpose of Observational Research

Observational research is a method of collecting and analyzing data by observing individuals or phenomena in their natural settings, without manipulating them in any way. The purpose of observational research is to gain insights into human behavior, attitudes, and preferences, as well as to identify patterns, trends, and relationships that may exist between variables.

The primary purpose of observational research is to generate hypotheses that can be tested through more rigorous experimental methods. By observing behavior and identifying patterns, researchers can develop a better understanding of the factors that influence human behavior, and use this knowledge to design experiments that test specific hypotheses.

Observational research is also used to generate descriptive data about a population or phenomenon. For example, an observational study of shoppers in a grocery store might reveal that women are more likely than men to buy organic produce. This type of information can be useful for marketers or policy-makers who want to understand consumer preferences and behavior.

In addition, observational research can be used to monitor changes over time. By observing behavior at different points in time, researchers can identify trends and changes that may be indicative of broader social or cultural shifts.

Overall, the purpose of observational research is to provide insights into human behavior and to generate hypotheses that can be tested through further research.

Advantages of Observational Research

There are several advantages to using observational research in different fields, including:

  • Naturalistic observation: Observational research allows researchers to observe behavior in a naturalistic setting, which means that people are observed in their natural environment without the constraints of a laboratory. This helps to ensure that the behavior observed is more representative of the real-world situation.
  • Unobtrusive : Observational research is often unobtrusive, which means that the researcher does not interfere with the behavior being observed. This can reduce the likelihood of the research being affected by the observer’s presence or the Hawthorne effect, where people modify their behavior when they know they are being observed.
  • Cost-effective : Observational research can be less expensive than other research methods, such as experiments or surveys. Researchers do not need to recruit participants or pay for expensive equipment, making it a more cost-effective research method.
  • Flexibility: Observational research is a flexible research method that can be used in a variety of settings and for a range of research questions. Observational research can be used to generate hypotheses, to collect data on behavior, or to monitor changes over time.
  • Rich data : Observational research provides rich data that can be analyzed to identify patterns and relationships between variables. It can also provide context for behaviors, helping to explain why people behave in a certain way.
  • Validity : Observational research can provide high levels of validity, meaning that the results accurately reflect the behavior being studied. This is because the behavior is being observed in a natural setting without interference from the researcher.

Disadvantages of Observational Research

While observational research has many advantages, it also has some limitations and disadvantages. Here are some of the disadvantages of observational research:

  • Observer bias: Observational research is prone to observer bias, which is when the observer’s own beliefs and assumptions affect the way they interpret and record behavior. This can lead to inaccurate or unreliable data.
  • Limited generalizability: The behavior observed in a specific setting may not be representative of the behavior in other settings. This can limit the generalizability of the findings from observational research.
  • Difficulty in establishing causality: Observational research is often correlational, which means that it identifies relationships between variables but does not establish causality. This can make it difficult to determine if a particular behavior is causing an outcome or if the relationship is due to other factors.
  • Ethical concerns: Observational research can raise ethical concerns if the participants being observed are unaware that they are being observed or if the observations invade their privacy.
  • Time-consuming: Observational research can be time-consuming, especially if the behavior being observed is infrequent or occurs over a long period of time. This can make it difficult to collect enough data to draw valid conclusions.
  • Difficulty in measuring internal processes: Observational research may not be effective in measuring internal processes, such as thoughts, feelings, and attitudes. This can limit the ability to understand the reasons behind behavior.

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Encyclopedia of Gerontology and Population Aging pp 1748–1756 Cite as

Experimental Studies and Observational Studies

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Experimental studies: Experiments, Randomized controlled trials (RCTs) ; Observational studies: Non-experimental studies, Non-manipulation studies, Naturalistic studies

Definitions

The experimental study is a powerful methodology for testing causal relations between one or more explanatory variables (i.e., independent variables) and one or more outcome variables (i.e., dependent variable). In order to accomplish this goal, experiments have to meet three basic criteria: (a) experimental manipulation (variation) of the independent variable(s), (b) randomization – the participants are randomly assigned to one of the experimental conditions, and (c) experimental control for the effect of third variables by eliminating them or keeping them constant.

In observational studies, investigators observe or assess individuals without manipulation or intervention. Observational studies are used for assessing the mean levels, the natural variation, and the structure of variables, as well as...

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Observational vs. Experimental Study: A Comprehensive Guide

Explore the fundamental disparities between experimental and observational studies in this comprehensive guide by Santos Research Center, Corp. Uncover concepts such as control group, random sample, cohort studies, response variable, and explanatory variable that shape the foundation of these methodologies. Discover the significance of randomized controlled trials and case control studies, examining causal relationships and the role of dependent variables and independent variables in research designs.

This enlightening exploration also delves into the meticulous scientific study process, involving survey members, systematic reviews, and statistical analyses. Investigate the careful balance of control group and treatment group dynamics, highlighting how researchers meticulously assign variables and analyze statistical patterns to discern meaningful insights. From dissecting issues like lung cancer to understanding sleep patterns, this guide emphasizes the precision of controlled experiments and controlled trials, where variables are isolated and scrutinized, paving the way for a deeper comprehension of the world through empirical research.

Introduction to Observational and Experimental Studies

These two studies are the cornerstones of scientific inquiry, each offering a distinct approach to unraveling the mysteries of the natural world.

Observational studies allow us to observe, document, and gather data without direct intervention. They provide a means to explore real-world scenarios and trends, making them valuable when manipulating variables is not feasible or ethical. From surveys to meticulous observations, these studies shed light on existing conditions and relationships.

Experimental studies , in contrast, put researchers in the driver's seat. They involve the deliberate manipulation of variables to understand their impact on specific outcomes. By controlling the conditions, experimental studies establish causal relationships, answering questions of causality with precision. This approach is pivotal for hypothesis testing and informed decision-making.

At Santos Research Center, Corp., we recognize the importance of both observational and experimental studies. We employ these methodologies in our diverse research projects to ensure the highest quality of scientific investigation and to answer a wide range of research questions.

Observational Studies: A Closer Look

In our exploration of research methodologies, let's zoom in on observational research studies—an essential facet of scientific inquiry that we at Santos Research Center, Corp., expertly employ in our diverse research projects.

What is an Observational Study?

Observational research studies involve the passive observation of subjects without any intervention or manipulation by researchers. These studies are designed to scrutinize the relationships between variables and test subjects, uncover patterns, and draw conclusions grounded in real-world data.

Researchers refrain from interfering with the natural course of events in controlled experiment. Instead, they meticulously gather data by keenly observing and documenting information about the test subjects and their surroundings. This approach permits the examination of variables that cannot be ethically or feasibly manipulated, making it particularly valuable in certain research scenarios.

Types of Observational Studies

Now, let's delve into the various forms that observational studies can take, each with its distinct characteristics and applications.

Cohort Studies:  A cohort study is a type of observational study that entails tracking one group of individuals over an extended period. Its primary goal is to identify potential causes or risk factors for specific outcomes or treatment group. Cohort studies provide valuable insights into the development of conditions or diseases and the factors that influence them.

Case-Control Studies:  Case-control studies, on the other hand, involve the comparison of individuals with a particular condition or outcome to those without it (the control group). These studies aim to discern potential causal factors or associations that may have contributed to the development of the condition under investigation.

Cross-Sectional Studies:  Cross-sectional studies take a snapshot of a diverse group of individuals at a single point in time. By collecting data from this snapshot, researchers gain insights into the prevalence of a specific condition or the relationships between variables at that precise moment. Cross-sectional studies are often used to assess the health status of the different groups within a population or explore the interplay between various factors.

Advantages and Limitations of Observational Studies

Observational studies, as we've explored, are a vital pillar of scientific research, offering unique insights into real-world phenomena. In this section, we will dissect the advantages and limitations that characterize these studies, shedding light on the intricacies that researchers grapple with when employing this methodology.

Advantages: One of the paramount advantages of observational studies lies in their utilization of real-world data. Unlike controlled experiments that operate in artificial settings, observational studies embrace the complexities of the natural world. This approach enables researchers to capture genuine behaviors, patterns, and occurrences as they unfold. As a result, the data collected reflects the intricacies of real-life scenarios, making it highly relevant and applicable to diverse settings and populations.

Moreover, in a randomized controlled trial, researchers looked to randomly assign participants to a group. Observational studies excel in their capacity to examine long-term trends. By observing one group of subjects over extended periods, research scientists gain the ability to track developments, trends, and shifts in behavior or outcomes. This longitudinal perspective is invaluable when studying phenomena that evolve gradually, such as chronic diseases, societal changes, or environmental shifts. It allows for the detection of subtle nuances that may be missed in shorter-term investigations.

Limitations: However, like any research methodology, observational studies are not without their limitations. One significant challenge of statistical study lies in the potential for biases. Since researchers do not intervene in the subjects' experiences, various biases can creep into the data collection process. These biases may arise from participant self-reporting, observer bias, or selection bias in random sample, among others. Careful design and rigorous data analysis are crucial for mitigating these biases.

Another limitation is the presence of confounding variables. In observational studies, it can be challenging to isolate the effect of a specific variable from the myriad of other factors at play. These confounding variables can obscure the true relationship between the variables of interest, making it difficult to establish causation definitively. Research scientists must employ statistical techniques to control for or adjust these confounding variables.

Additionally, observational studies face constraints in their ability to establish causation. While they can identify associations and correlations between variables, they cannot prove causality or causal relationship. Establishing causation typically requires controlled experiments where researchers can manipulate independent variables systematically. In observational studies, researchers can only infer potential causation based on the observed associations.

Experimental Studies: Delving Deeper

In the intricate landscape of scientific research, we now turn our gaze toward experimental studies—a dynamic and powerful method that Santos Research Center, Corp. skillfully employs in our pursuit of knowledge.

What is an Experimental Study?

While some studies observe and gather data passively, experimental studies take a more proactive approach. Here, researchers actively introduce an intervention or treatment to an experiment group study its effects on one or more variables. This methodology empowers researchers to manipulate independent variables deliberately and examine their direct impact on dependent variables.

Experimental research are distinguished by their exceptional ability to establish cause-and-effect relationships. This invaluable characteristic allows researchers to unlock the mysteries of how one variable influences another, offering profound insights into the scientific questions at hand. Within the controlled environment of an experimental study, researchers can systematically test hypotheses, shedding light on complex phenomena.

Key Features of Experimental Studies

Central to statistical analysis, the rigor and reliability of experimental studies are several key features that ensure the validity of their findings.

Randomized Controlled Trials:  Randomization is a critical element in experimental studies, as it ensures that subjects are assigned to groups in a random assignment. This randomly assigned allocation minimizes the risk of unintentional biases and confounding variables, strengthening the credibility of the study's outcomes.

Control Groups:  Control groups play a pivotal role in experimental studies by serving as a baseline for comparison. They enable researchers to assess the true impact of the intervention being studied. By comparing the outcomes of the intervention group to those of survey members of the control group, researchers can discern whether the intervention caused the observed changes.

Blinding:  Both single-blind and double-blind techniques are employed in experimental studies to prevent biases from influencing the study or controlled trial's outcomes. Single-blind studies keep either the subjects or the researchers unaware of certain aspects of the study, while double-blind studies extend this blindness to both parties, enhancing the objectivity of the study.

These key features work in concert to uphold the integrity and trustworthiness of the results generated through experimental studies.

Advantages and Limitations of Experimental Studies

As with any research methodology, this one comes with its unique set of advantages and limitations.

Advantages:  These studies offer the distinct advantage of establishing causal relationships between two or more variables together. The controlled environment allows researchers to exert authority over variables, ensuring that changes in the dependent variable can be attributed to the independent variable. This meticulous control results in high-quality, reliable data that can significantly contribute to scientific knowledge.

Limitations:  However, experimental ones are not without their challenges. They may raise ethical concerns, particularly when the interventions involve potential risks to subjects. Additionally, their controlled nature can limit their real-world applicability, as the conditions in experiments may not accurately mirror those in the natural world. Moreover, executing an experimental study in randomized controlled, often demands substantial resources, with other variables including time, funding, and personnel.

Observational vs Experimental: A Side-by-Side Comparison

Having previously examined observational and experimental studies individually, we now embark on a side-by-side comparison to illuminate the key distinctions and commonalities between these foundational research approaches.

Key Differences and Notable Similarities

Methodologies

  • Observational Studies : Characterized by passive observation, where researchers collect data without direct intervention, allowing the natural course of events to unfold.
  • Experimental Studies : Involve active intervention, where researchers deliberately manipulate variables to discern their impact on specific outcomes, ensuring control over the experimental conditions.
  • Observational Studies : Designed to identify patterns, correlations, and associations within existing data, shedding light on relationships within real-world settings.
  • Experimental Studies : Geared toward establishing causality by determining the cause-and-effect relationships between variables, often in controlled laboratory environments.
  • Observational Studies : Yield real-world data, reflecting the complexities and nuances of natural phenomena.
  • Experimental Studies : Generate controlled data, allowing for precise analysis and the establishment of clear causal connections.

Observational studies excel at exploring associations and uncovering patterns within the intricacies of real-world settings, while experimental studies shine as the gold standard for discerning cause-and-effect relationships through meticulous control and manipulation in controlled environments. Understanding these differences and similarities empowers researchers to choose the most appropriate method for their specific research objectives.

When to Use Which: Practical Applications

The decision to employ either observational or experimental studies hinges on the research objectives at hand and the available resources. Observational studies prove invaluable when variable manipulation is impractical or ethically challenging, making them ideal for delving into long-term trends and uncovering intricate associations between certain variables (response variable or explanatory variable). On the other hand, experimental studies emerge as indispensable tools when the aim is to definitively establish causation and methodically control variables.

At Santos Research Center, Corp., our approach to both scientific study and methodology is characterized by meticulous consideration of the specific research goals. We recognize that the quality of outcomes hinges on selecting the most appropriate method of research study. Our unwavering commitment to employing both observational and experimental research studies further underscores our dedication to advancing scientific knowledge across diverse domains.

Conclusion: The Synergy of Experimental and Observational Studies in Research

In conclusion, both observational and experimental studies are integral to scientific research, offering complementary approaches with unique strengths and limitations. At Santos Research Center, Corp., we leverage these methodologies to contribute meaningfully to the scientific community.

Explore our projects and initiatives at Santos Research Center, Corp. by visiting our website or contacting us at (813) 249-9100, where our unwavering commitment to rigorous research practices and advancing scientific knowledge awaits.

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Observational and interventional study design types; an overview

Affiliation.

  • 1 Rocky Mountain Center for Occupational and Environmental Health, University of Utah, Salt Lake City, Utah, USA.
  • PMID: 24969913
  • PMCID: PMC4083571
  • DOI: 10.11613/BM.2014.022

The appropriate choice in study design is essential for the successful execution of biomedical and public health research. There are many study designs to choose from within two broad categories of observational and interventional studies. Each design has its own strengths and weaknesses, and the need to understand these limitations is necessary to arrive at correct study conclusions.Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods. Observational study designs include ecological designs, cross sectional, case-control, case-crossover, retrospective and prospective cohorts. An important subset of observational studies is diagnostic study designs, which evaluate the accuracy of diagnostic procedures and tests as compared to other diagnostic measures. These include diagnostic accuracy designs, diagnostic cohort designs, and diagnostic randomized controlled trials.Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease. Each study design has specific outcome measures that rely on the type and quality of data utilized. Additionally, each study design has potential limitations that are more severe and need to be addressed in the design phase of the study. This manuscript is meant to provide an overview of study design types, strengths and weaknesses of common observational and interventional study designs.

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  • Biomedical Research
  • Epidemiologic Studies*
  • Observational Studies as Topic*
  • Randomized Controlled Trials as Topic
  • Research Design / standards*
  • Treatment Outcome
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Original research article, learning scientific observation with worked examples in a digital learning environment.

is observational study a research design

  • 1 Department Educational Sciences, Chair for Formal and Informal Learning, Technical University Munich School of Social Sciences and Technology, Munich, Germany
  • 2 Aquatic Systems Biology Unit, TUM School of Life Sciences, Technical University of Munich, Freising, Germany

Science education often aims to increase learners’ acquisition of fundamental principles, such as learning the basic steps of scientific methods. Worked examples (WE) have proven particularly useful for supporting the development of such cognitive schemas and successive actions in order to avoid using up more cognitive resources than are necessary. Therefore, we investigated the extent to which heuristic WE are beneficial for supporting the acquisition of a basic scientific methodological skill—conducting scientific observation. The current study has a one-factorial, quasi-experimental, comparative research design and was conducted as a field experiment. Sixty two students of a German University learned about scientific observation steps during a course on applying a fluvial audit, in which several sections of a river were classified based on specific morphological characteristics. In the two experimental groups scientific observation was supported either via faded WE or via non-faded WE both presented as short videos. The control group did not receive support via WE. We assessed factual and applied knowledge acquisition regarding scientific observation, motivational aspects and cognitive load. The results suggest that WE promoted knowledge application: Learners from both experimental groups were able to perform the individual steps of scientific observation more accurately. Fading of WE did not show any additional advantage compared to the non-faded version in this regard. Furthermore, the descriptive results reveal higher motivation and reduced extraneous cognitive load within the experimental groups, but none of these differences were statistically significant. Our findings add to existing evidence that WE may be useful to establish scientific competences.

1 Introduction

Learning in science education frequently involves the acquisition of basic principles or generalities, whether of domain-specific topics (e.g., applying a mathematical multiplication rule) or of rather universal scientific methodologies (e.g., performing the steps of scientific observation) ( Lunetta et al., 2007 ). Previous research has shown that worked examples (WE) can be considered particularly useful for developing such cognitive schemata during learning to avoid using more cognitive resources than necessary for learning successive actions ( Renkl et al., 2004 ; Renkl, 2017 ). WE consist of the presentation of a problem, consecutive solution steps and the solution itself. This is especially advantageous in initial cognitive skill acquisition, i.e., for novice learners with low prior knowledge ( Kalyuga et al., 2001 ). With growing knowledge, fading WE can lead from example-based learning to independent problem-solving ( Renkl et al., 2002 ). Preliminary work has shown the advantage of WE in specific STEM domains like mathematics ( Booth et al., 2015 ; Barbieri et al., 2021 ), but less studies have investigated their impact on the acquisition of basic scientific competencies that involve heuristic problem-solving processes (scientific argumentation, Schworm and Renkl, 2007 ; Hefter et al., 2014 ; Koenen et al., 2017 ). In the realm of natural sciences, various basic scientific methodologies are employed to acquire knowledge, such as experimentation or scientific observation ( Wellnitz and Mayer, 2013 ). During the pursuit of knowledge through scientific inquiry activities, learners may encounter several challenges and difficulties. Similar to the hurdles faced in experimentation, where understanding the criteria for appropriate experimental design, including the development, measurement, and evaluation of results, is crucial ( Sirum and Humburg, 2011 ; Brownell et al., 2014 ; Dasgupta et al., 2014 ; Deane et al., 2014 ), scientific observation additionally presents its own set of issues. In scientific observation, e.g., the acquisition of new insights may be somewhat incidental due to spontaneous and uncoordinated observations ( Jensen, 2014 ). To address these challenges, it is crucial to provide instructional support, including the use of WE, particularly when observations are carried out in a more self-directed manner.

For this reason, the aim of the present study was to determine the usefulness of digitally presented WE to support the acquisition of a basic scientific methodological skill—conducting scientific observations—using a digital learning environment. In this regard, this study examined the effects of different forms of digitally presented WE (non-faded vs. faded) on students’ cognitive and motivational outcomes and compared them to a control group without WE. Furthermore, the combined perspective of factual and applied knowledge, as well as motivational and cognitive aspects, represent further value added to the study.

2 Theoretical background

2.1 worked examples.

WE have been commonly used in the fields of STEM education (science, technology, engineering, and mathematics) ( Booth et al., 2015 ). They consist of a problem statement, the steps to solve the problem, and the solution itself ( Atkinson et al., 2000 ; Renkl et al., 2002 ; Renkl, 2014 ). The success of WE can be explained by their impact on cognitive load (CL) during learning, based on assumptions from Cognitive Load Theory ( Sweller, 2006 ).

Learning with WE is considered time-efficient, effective, and superior to problem-based learning (presentation of the problem without demonstration of solution steps) when it comes to knowledge acquisition and transfer (WE-effect, Atkinson et al., 2000 ; Van Gog et al., 2011 ). Especially WE can help by reducing the extraneous load (presentation and design of the learning material) and, in turn, can lead to an increase in germane load (effort of the learner to understand the learning material) ( Paas et al., 2003 ; Renkl, 2014 ). With regard to intrinsic load (difficulty and complexity of the learning material), it is still controversially discussed if it can be altered by instructional design, e.g., WE ( Gerjets et al., 2004 ). WE have a positive effect on learning and knowledge transfer, especially for novices, as the step-by-step presentation of the solution requires less extraneous mental effort compared to problem-based learning ( Sweller et al., 1998 ; Atkinson et al., 2000 ; Bokosmaty et al., 2015 ). With growing knowledge, WE can lose their advantages (due to the expertise-reversal effect), and scaffolding learning via faded WE might be more successful for knowledge gain and transfer ( Renkl, 2014 ). Faded WE are similar to complete WE, but fade out solution steps as knowledge and competencies grow. Faded WE enhance near-knowledge transfer and reduce errors compared to non-faded WE ( Renkl et al., 2000 ).

In addition, the reduction of intrinsic and extraneous CL by WE also has an impact on learner motivation, such as interest ( Van Gog and Paas, 2006 ). Um et al. (2012) showed that there is a strong positive correlation between germane CL and the motivational aspects of learning, like satisfaction and emotion. Gupta (2019) mentions a positive correlation between CL and interest. Van Harsel et al. (2019) found that WE positively affect learning motivation, while no such effect was found for problem-solving. Furthermore, learning with WE increases the learners’ belief in their competence in completing a task. In addition, fading WE can lead to higher motivation for more experienced learners, while non-faded WE can be particularly motivating for learners without prior knowledge ( Paas et al., 2005 ). In general, fundamental motivational aspects during the learning process, such as situational interest ( Lewalter and Knogler, 2014 ) or motivation-relevant experiences, like basic needs, are influenced by learning environments. At the same time, their use also depends on motivational characteristics of the learning process, such as self-determined motivation ( Deci and Ryan, 2012 ). Therefore, we assume that learning with WE as a relevant component of a learning environment might also influence situational interest and basic needs.

2.1.1 Presentation of worked examples

WE are frequently used in digital learning scenarios ( Renkl, 2014 ). When designing WE, the application via digital learning media can be helpful, as their content can be presented in different ways (video, audio, text, and images), tailored to the needs of the learners, so that individual use is possible according to their own prior knowledge or learning pace ( Mayer, 2001 ). Also, digital media can present relevant information in a timely, motivating, appealing and individualized way and support learning in an effective and needs-oriented way ( Mayer, 2001 ). The advantages of using digital media in designing WE have already been shown in previous studies. Dart et al. (2020) presented WE as short videos (WEV). They report that the use of WEV leads to increased student satisfaction and more positive attitudes. Approximately 90% of the students indicated an active learning approach when learning with the WEV. Furthermore, the results show that students improved their content knowledge through WEV and that they found WEV useful for other courses as well.

Another study ( Kay and Edwards, 2012 ) presented WE as video podcasts. Here, the advantages of WE regarding self-determined learning in terms of learning location, learning time, and learning speed were shown. Learning performance improved significantly after use. The step-by-step, easy-to-understand explanations, the diagrams, and the ability to determine the learning pace by oneself were seen as beneficial.

Multimedia WE can also be enhanced with self-explanation prompts ( Berthold et al., 2009 ). Learning from WE with self-explanation prompts was shown to be superior to other learning methods, such as hypertext learning and observational learning.

In addition to presenting WE in different medial ways, WE can also comprise different content domains.

2.1.2 Content and context of worked examples

Regarding the content of WE, algorithmic and heuristic WE, as well as single-content and double-content WE, can be distinguished ( Reiss et al., 2008 ; Koenen et al., 2017 ; Renkl, 2017 ). Algorithmic WE are traditionally used in the very structured mathematical–physical field. Here, an algorithm with very specific solution steps is to learn, for example, in probability calculation ( Koenen et al., 2017 ). In this study, however, we focus on heuristic double-content WE. Heuristic WE in science education comprise fundamental scientific working methods, e.g., conducting experiments ( Koenen et al., 2017 ). Furthermore, double-content WE contain two learning domains that are relevant for the learning process: (1) the learning domain describes the primarily to be learned abstract process or concept, e.g., scientific methodologies like observation (see section 2.2), while (2) the exemplifying domain consists of the content that is necessary to teach this process or concept, e.g., mapping of river structure ( Renkl et al., 2009 ).

Depending on the WE content to be learned, it may be necessary for learning to take place in different settings. This can be in a formal or informal learning setting or a non-formal field setting. In this study, the focus is on learning scientific observation (learning domain) through river structure mapping (exemplary domain), which takes place with the support of digital media in a formal (university) setting, but in an informal context (nature).

2.2 Scientific observation

Scientific observation is fundamental to all scientific activities and disciplines ( Kohlhauf et al., 2011 ). Scientific observation must be clearly distinguished from everyday observation, where observation is purely a matter of noticing and describing specific characteristics ( Chinn and Malhotra, 2001 ). In contrast to this everyday observation, scientific observation as a method of knowledge acquisition can be described as a rather complex activity, defined as the theory-based, systematic and selective perception of concrete systems and processes without any fundamental manipulation ( Wellnitz and Mayer, 2013 ). Wellnitz and Mayer (2013) described the scientific observation process via six steps: (1) formulation of the research question (s), (2) deduction of the null hypothesis and the alternative hypothesis, (3) planning of the research design, (4) conducting the observation, (5) analyzing the data, and (6) answering the research question(s) on this basis. Only through reliable and qualified observation, valid data can be obtained that provide solid scientific evidence ( Wellnitz and Mayer, 2013 ).

Since observation activities are not trivial and learners often observe without generating new knowledge or connecting their observations to scientific explanations and thoughts, it is important to provide support at the related cognitive level, so that observation activities can be conducted in a structured way according to pre-defined criteria ( Ford, 2005 ; Eberbach and Crowley, 2009 ). Especially during field-learning experiences, scientific observation is often spontaneous and uncoordinated, whereby random discoveries result in knowledge gain ( Jensen, 2014 ).

To promote successful observing in rather unstructured settings like field trips, instructional support for the observation process seems useful. To guide observation activities, digitally presented WE seem to be an appropriate way to introduce learners to the individual steps of scientific observation using concrete examples.

2.3 Research questions and hypothesis

The present study investigates the effect of digitally presented double-content WE that supports the mapping of a small Bavarian river by demonstrating the steps of scientific observation. In this analysis, we focus on the learning domain of the WE and do not investigate the exemplifying domain in detail. Distinct ways of integrating WE in the digital learning environment (faded WE vs. non-faded WE) are compared with each other and with a control group (no WE). The aim is to examine to what extent differences between those conditions exist with regard to (RQ1) learners’ competence acquisition [acquisition of factual knowledge about the scientific observation method (quantitative data) and practical application of the scientific observation method (quantified qualitative data)], (RQ2) learners’ motivation (situational interest and basic needs), and (RQ3) CL. It is assumed that (Hypothesis 1), the integration of WE (faded and non-faded) leads to significantly higher competence acquisition (factual and applied knowledge), significantly higher motivation and significantly lower extraneous CL as well as higher germane CL during the learning process compared to a learning environment without WE. No differences between the conditions are expected regarding intrinsic CL. Furthermore, it is assumed (Hypothesis 2) that the integration of faded WE leads to significantly higher competence acquisition, significantly higher motivation, and lower extraneous CL as well as higher germane CL during the learning processes compared to non-faded WE. No differences between the conditions are expected with regard to intrinsic CL.

The study took place during the field trips of a university course on the application of a fluvial audit (FA) using the German working aid for mapping the morphology of rivers and their floodplains ( Bayerisches Landesamt für Umwelt, 2019 ). FA is the leading fluvial geomorphological tool for application to data collection contiguously along all watercourses of interest ( Walker et al., 2007 ). It is widely used because it is a key example of environmental conservation and monitoring that needs to be taught to students of selected study programs; thus, knowing about the most effective ways of learning is of high practical relevance.

3.1 Sample and design

3.1.1 sample.

The study was conducted with 62 science students and doctoral students of a German University (age M  = 24.03 years; SD  = 4.20; 36 females; 26 males). A total of 37 participants had already conducted a scientific observation and would rate their knowledge in this regard at a medium level ( M  = 3.32 out of 5; SD  = 0.88). Seven participants had already conducted an FA and would rate their knowledge in this regard at a medium level ( M  = 3.14 out of 5; SD  = 0.90). A total of 25 participants had no experience at all. Two participants had to be excluded from the sample afterward because no posttest results were available.

3.1.2 Design

The study has a 1-factorial quasi-experimental comparative research design and is conducted as a field experiment using a pre/posttest design. Participants were randomly assigned to one of three conditions: no WE ( n  = 20), faded WE ( n  = 20), and non-faded WE ( n  = 20).

3.2 Implementation and material

3.2.1 implementation.

The study started with an online kick-off meeting where two lecturers informed all students within an hour about the basics regarding the assessment of the structural integrity of the study river and the course of the field trip days to conduct an FA. Afterward, within 2 weeks, students self-studied via Moodle the FA following the German standard method according to the scoresheets of Bayerisches Landesamt für Umwelt (2019) . This independent preparation using the online presented documents was a necessary prerequisite for participation in the field days and was checked in the pre-testing. The preparatory online documents included six short videos and four PDF files on the content, guidance on the German protocol of the FA, general information on river landscapes, information about anthropogenic changes in stream morphology and the scoresheets for applying the FA. In these sheets, the river and its floodplain are subdivided into sections of 100 m in length. Each of these sections is evaluated by assessing 21 habitat factors related to flow characteristics and structural variability. The findings are then transferred into a scoring system for the description of structural integrity from 1 (natural) to 7 (highly modified). Habitat factors have a decisive influence on the living conditions of animals and plants in and around rivers. They included, e.g., variability in water depth, stream width, substratum diversity, or diversity of flow velocities.

3.2.2 Materials

On the field trip days, participants were handed a tablet and a paper-based FA worksheet (last accessed 21st September 2022). 1 This four-page assessment sheet was accompanied by a digital learning environment presented on Moodle that instructed the participants on mapping the water body structure and guided the scientific observation method. All three Moodle courses were identical in structure and design; the only difference was the implementation of the WE. Below, the course without WE are described first. The other two courses have an identical structure, but contain additional WE in the form of learning videos.

3.2.3 No worked example

After a short welcome and introduction to the course navigation, the FA started with the description of a short hypothetical scenario: Participants should take the role of an employee of an urban planning office that assesses the ecomorphological status of a small river near a Bavarian city. The river was divided into five sections that had to be mapped separately. The course was structured accordingly. At the beginning of each section, participants had to formulate and write down a research question, and according to hypotheses regarding the ecomorphological status of the river’s section, they had to collect data in this regard via the mapping sheet and then evaluate their data and draw a conclusion. Since this course serves as a control group, no WE videos supporting the scientific observation method were integrated. The layout of the course is structured like a book, where it is not possible to scroll back. This is important insofar as the participants do not have the possibility to revisit information in order to keep the conditions comparable as well as distinguishable.

3.2.4 Non-faded worked example

In the course with no-faded WE, three instructional videos are shown for each of the five sections. In each of the three videos, two steps of the scientific observation method are presented so that, finally, all six steps of scientific observation are demonstrated. The mapping of the first section starts after the general introduction (as described above) with the instruction to work on the first two steps of scientific observation: the formulation of a research question and hypotheses. To support this, a video of about 4 min explains the features of scientific sound research questions and hypotheses. To this aim, a practical example, including explanations and tips, is given regarding the formulation of research questions and hypotheses for this section (e.g., “To what extent does the building development and the closeness of the path to the water body have an influence on the structure of the water body?” Alternative hypothesis: It is assumed that the housing development and the closeness of the path to the water body have a negative influence on the water body structure. Null hypothesis: It is assumed that the housing development and the closeness of the path to the watercourse have no negative influence on the watercourse structure.). Participants should now formulate their own research questions and hypotheses, write them down in a text field at the end of the page, and then skip to the next page. The next two steps of scientific observation, planning and conducting, are explained in a short 4-min video. To this aim, a practical example including explanations and tips is given regarding planning and conducting scientific for this section (e.g., “It’s best to go through each evaluation category carefully one by one that way you are sure not to forget anything!”). Now, participants were asked to collect data for the first section using their paper-based FA worksheet. Participants individually surveyed the river and reported their results in the mapping sheet by ticking the respective boxes in it. After collecting this data, they returned to the digital learning environment to learn how to use these data by studying the last two steps of scientific observation, evaluation, and conclusion. The third 4-min video explained how to evaluate and interpret collected data. For this purpose, a practical example with explanations and tips is given regarding evaluating and interpreting data for this section (e.g., “What were the individual points that led to the assessment? Have there been points that were weighted more than others? Remember the introduction video!”). At the end of the page, participants could answer their before-stated research questions and hypotheses by evaluating their collected data and drawing a conclusion. This brings participants to the end of the first mapping section. Afterward, the cycle begins again with the second section of the river that has to be mapped. Again, participants had to conduct the steps of scientific observation, guided by WE videos, explaining the steps in slightly different wording or with different examples. A total of five sections are mapped, in which the structure of the learning environment and the videos follow the same procedure.

3.2.5 Faded worked example

The digital learning environment with the faded WE follow the same structure as the version with the non-faded WE. However, in this version, the information in the WE videos is successively reduced. In the first section, all three videos are identical to the version with the non-faded WE. In the second section, faded content was presented as follows: the tip at the end was omitted in all three videos. In the third section, the tip and the practical example were omitted. In the fourth and fifth sections, no more videos were presented, only the work instructions.

3.3 Procedure

The data collection took place on four continuous days on the university campus, with a maximum group size of 15 participants on each day. The students were randomly assigned to one of the three conditions (no WE vs. faded WE vs. non-faded WE). After a short introduction to the procedure, the participants were handed the paper-based FA worksheet and one tablet per person. Students scanned the QR code on the first page of the worksheet that opened the pretest questionnaire, which took about 20 min to complete. After completing the questionnaire, the group walked for about 15 min to the nearby small river that was to be mapped. Upon arrival, there was first a short introduction to the digital learning environment and a check that the login (via university account on Moodle) worked. During the next 4 h, the participants individually mapped five segments of the river using the cartography worksheet. They were guided through the steps of scientific observation using the digital learning environment on the tablet. The results of their scientific observation were logged within the digital learning environment. At the end of the digital learning environment, participants were directed to the posttest via a link. After completing the test, the tablets and mapping sheets were returned. Overall, the study took about 5 h per group each day.

3.4 Instruments

In the pretest, sociodemographic data (age and gender), the study domain and the number of study semesters were collected. Additionally, the previous scientific observation experience and the estimation of one’s own ability in this regard were assessed. For example, it was asked whether scientific observation had already been conducted and, if so, how the abilities were rated on a 5-point scale from very low to very high. Preparation for the FA on the basis of the learning material was assessed: Participants were asked whether they had studied all six videos and all four PDF documents, with the response options not at all, partially, and completely. Furthermore, a factual knowledge test about scientific observation and questions about self-determination theory was administered. The posttest used the same knowledge test, and additional questions on basic needs, situational interest, measures of CL and questions about the usefulness of the WE. All scales were presented online, and participants reached the questionnaire via QR code.

3.4.1 Scientific observation competence acquisition

For the factual knowledge (quantitative assessment of the scientific observation competence), a single-choice knowledge test with 12 questions was developed and used as pre- and posttest with a maximum score of 12 points. It assesses the learners’ knowledge of the scientific observation method regarding the steps of scientific observation, e.g., formulating research questions and hypotheses or developing a research design. The questions are based on Wahser (2008 , adapted by Koenen, 2014 ) and adapted to scientific observation: “Although you are sure that you have conducted the scientific observation correctly, an unexpected result turns up. What conclusion can you draw?” Each question has four answer options (one of which is correct) and, in addition, one “I do not know” option.

For the applied knowledge (quantified qualitative assessment of the scientific observation competence), students’ scientific observations written in the digital learning environment were analyzed. A coding scheme was used with the following codes: 0 = insufficient (text field is empty or includes only insufficient key points), 1 = sufficient (a research question and no hypotheses or research question and inappropriate hypotheses are stated), 2 = comprehensive (research question and appropriate hypothesis or research question and hypotheses are stated, but, e.g., incorrect null hypothesis), 3 = very comprehensive (correct research question, hypothesis and null hypothesis are stated). One example of a very comprehensive answer regarding the research question and hypothesis is: To what extent does the lack of riparian vegetation have an impact on water body structure? Hypothesis: The lack of shore vegetation has a negative influence on the water body structure. Null hypothesis: The lack of shore vegetation has no influence on the water body structure. Afterward, a sum score was calculated for each participant. Five times, a research question and hypotheses (steps 1 and 2 in the observation process) had to be formulated (5 × max. 3 points = 15 points), and five times, the research questions and hypotheses had to be answered (steps 5 and 6 in the observation process: evaluation and conclusion) (5 × max. 3 points = 15 points). Overall, participants could reach up to 30 points. Since the observation and evaluation criteria in data collection and analysis were strongly predetermined by the scoresheet, steps 3 and 4 of the observation process (planning and conducting) were not included in the analysis.

All 600 cases (60 participants, each 10 responses to code) were coded by the first author. For verification, 240 cases (24 randomly selected participants, eight from each course) were cross-coded by an external coder. In 206 of the coded cases, the raters agreed. The cases in which the raters did not agree were discussed together, and a solution was found. This results in Cohen’s κ = 0.858, indicating a high to very high level of agreement. This indicates that the category system is clearly formulated and that the individual units of analysis could be correctly assigned.

3.4.2 Self-determination index

For the calculation of the self-determination index (SDI-index), Thomas and Müller (2011) scale for self-determination was used in the pretest. The scale consists of four subscales: intrinsic motivation (five items; e.g., I engage with the workshop content because I enjoy it; reliability of alpha = 0.87), identified motivation (four items; e.g., I engage with the workshop content because it gives me more options when choosing a career; alpha = 0.84), introjected motivation (five items; e.g., I engage with the workshop content because otherwise I would have a guilty feeling; alpha = 0.79), and external motivation (three items, e.g., I engage with the workshop content because I simply have to learn it; alpha = 0.74). Participants could indicate their answers on a 5-point Likert scale ranging from 1 = completely disagree to 5 = completely agree. To calculate the SDI-index, the sum of the self-determined regulation styles (intrinsic and identified) is subtracted from the sum of the external regulation styles (introjected and external), where intrinsic and external regulation are scored two times ( Thomas and Müller, 2011 ).

3.4.3 Motivation

Basic needs were measured in the posttest with the scale by Willems and Lewalter (2011) . The scale consists of three subscales: perceived competence (four items; e.g., during the workshop, I felt that I could meet the requirements; alpha = 0.90), perceived autonomy (five items; e.g., during the workshop, I felt that I had a lot of freedom; alpha = 0.75), and perceived autonomy regarding personal wishes and goals (APWG) (four items; e.g., during the workshop, I felt that the workshop was how I wish it would be; alpha = 0.93). We added all three subscales to one overall basic needs scale (alpha = 0.90). Participants could indicate their answers on a 5-point Likert scale ranging from 1 = completely disagree to 5 = completely agree.

Situational interest was measured in the posttest with the 12-item scale by Lewalter and Knogler (2014 ; Knogler et al., 2015 ; Lewalter, 2020 ; alpha = 0.84). The scale consists of two subscales: catch (six items; e.g., I found the workshop exciting; alpha = 0.81) and hold (six items; e.g., I would like to learn more about parts of the workshop; alpha = 0.80). Participants could indicate their answers on a 5-point Likert scale ranging from 1 = completely disagree to 5 = completely agree.

3.4.4 Cognitive load

In the posttest, CL was used to examine the mental load during the learning process. The intrinsic CL (three items; e.g., this task was very complex; alpha = 0.70) and extraneous CL (three items; e.g., in this task, it is difficult to identify the most important information; alpha = 0.61) are measured with the scales from Klepsch et al. (2017) . The germane CL (two items; e.g., the learning session contained elements that supported me to better understand the learning material; alpha = 0.72) is measured with the scale from Leppink et al. (2013) . Participants could indicate their answers on a 5-point Likert scale ranging from 1 = completely disagree to 5 = completely agree.

3.4.5 Attitudes toward worked examples

To measure how effective participants rated the WE, we used two scales related to the WE videos as instructional support. The first scale from Renkl (2001) relates to the usefulness of WE. The scale consists of four items (e.g., the explanations were helpful; alpha = 0.71). Two items were recoded because they were formulated negatively. The second scale is from Wachsmuth (2020) and relates to the participant’s evaluation of the WE. The scale consists of nine items (e.g., I always did what was explained in the learning videos; alpha = 0.76). Four items were recoded because they were formulated negatively. Participants could indicate their answers on a 5-point Likert scale ranging from 1 = completely disagree to 5 = completely agree.

3.5 Data analysis

An ANOVA was used to calculate if the variable’s prior knowledge and SDI index differed between the three groups. However, as no significant differences between the conditions were found [prior factual knowledge: F (2, 59) = 0.15, p  = 0.865, η 2  = 0.00 self-determination index: F (2, 59) = 0.19, p  = 0.829, η 2  = 0.00], they were not included as covariates in subsequent analyses.

Furthermore, a repeated measure, one-way analysis of variance (ANOVA), was conducted to compare the three treatment groups (no WE vs. faded WE vs. non-faded WE) regarding the increase in factual knowledge about the scientific observation method from pretest to posttest.

A MANOVA (multivariate analysis) was calculated with the three groups (no WE vs. non-faded WE vs. faded WE) as a fixed factor and the dependent variables being the practical application of the scientific observation method (first research question), situational interest, basic needs (second research question), and CL (third research question).

Additionally, to determine differences in applied knowledge even among the three groups, Bonferroni-adjusted post-hoc analyses were conducted.

The descriptive statistics between the three groups in terms of prior factual knowledge about the scientific observation method and the self-determination index are shown in Table 1 . The descriptive statistics revealed only small, non-significant differences between the three groups in terms of factual knowledge.

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Table 1 . Means (standard deviations) of factual knowledge tests (pre- and posttest) and self-determination index for the three different groups.

The results of the ANOVA revealed that the overall increase in factual knowledge from pre- to posttest just misses significance [ F (1, 57) = 3.68, p  = 0.060, η 2  = 0 0.06]. Furthermore, no significant differences between the groups were found regarding the acquisition of factual knowledge from pre- to posttest [ F (2, 57) = 2.93, p  = 0.062, η 2  = 0.09].

An analysis of the descriptive statistics showed that the largest differences between the groups were found in applied knowledge (qualitative evaluation) and extraneous load (see Table 2 ).

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Table 2 . Means (standard deviations) of dependent variables with the three different groups.

Results of the MANOVA revealed significant overall differences between the three groups [ F (12, 106) = 2.59, p  = 0.005, η 2  = 0.23]. Significant effects were found for the application of knowledge [ F (2, 57) = 13.26, p  = <0.001, η 2  = 0.32]. Extraneous CL just missed significance [ F (2, 57) = 2.68, p  = 0.065, η 2  = 0.09]. There were no significant effects for situational interest [ F (2, 57) = 0.44, p  = 0.644, η 2  = 0.02], basic needs [ F (2, 57) = 1.22, p  = 0.302, η 2  = 0.04], germane CL [ F (2, 57) = 2.68, p  = 0.077, η 2  = 0.09], and intrinsic CL [ F (2, 57) = 0.28, p  = 0.757, η 2  = 0.01].

Bonferroni-adjusted post hoc analysis revealed that the group without WE had significantly lower scores in the evaluation of the applied knowledge than the group with non-faded WE ( p  = <0.001, M diff  = −8.90, 95% CI [−13.47, −4.33]) and then the group with faded WE ( p  = <0.001, M diff  = −7.40, 95% CI [−11.97, −2.83]). No difference was found between the groups with faded and non-faded WE ( p  = 1.00, M diff  = −1.50, 95% CI [−6.07, 3.07]).

The descriptive statistics regarding the perceived usefulness of WE and participants’ evaluation of the WE revealed that the group with the faded WE rated usefulness slightly higher than the participants with non-faded WE and also reported a more positive evaluation. However, the results of a MANOVA revealed no significant overall differences [ F (2, 37) = 0.32, p  = 0.732, η 2  = 0 0.02] (see Table 3 ).

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Table 3 . Means (standard deviations) of dependent variables with the three different groups.

5 Discussion

This study investigated the use of WE to support students’ acquisition of science observation. Below, the research questions are answered, and the implications and limitations of the study are discussed.

5.1 Results on factual and applied knowledge

In terms of knowledge gain (RQ1), our findings revealed no significant differences in participants’ results of the factual knowledge test both across all three groups and specifically between the two experimental groups. These results are in contradiction with related literature where WE had a positive impact on knowledge acquisition ( Renkl, 2014 ) and faded WE are considered to be more effective in knowledge acquisition and transfer, in contrast to non-faded WE ( Renkl et al., 2000 ; Renkl, 2014 ). A limitation of the study is the fact that the participants already scored very high on the pretest, so participation in the intervention would likely not yield significant knowledge gains due to ceiling effects ( Staus et al., 2021 ). Yet, nearly half of the students reported being novices in the field prior to the study, suggesting that the difficulty of some test items might have been too low. Here, it would be important to revise the factual knowledge test, e.g., the difficulty of the distractors in further study.

Nevertheless, with regard to application knowledge, the results revealed large significant differences: Participants of the two experimental groups performed better in conducting scientific observation steps than participants of the control group. In the experimental groups, the non-faded WE group performed better than the faded WE group. However, the absence of significant differences between the two experimental groups suggests that faded and non-faded WE used as double-content WE are suitable to teach applied knowledge about scientific observation in the learning domain ( Koenen, 2014 ). Furthermore, our results differ from the findings of Renkl et al. (2000) , in which the faded version led to the highest knowledge transfer. Despite the fact that the non-faded WE performed best in our study, the faded version of the WE was also appropriate to improve learning, confirming the findings of Renkl (2014) and Hesser and Gregory (2015) .

5.2 Results on learners’ motivation

Regarding participants’ motivation (RQ2; situational interest and basic needs), no significant differences were found across all three groups or between the two experimental groups. However, descriptive results reveal slightly higher motivation in the two experimental groups than in the control group. In this regard, our results confirm existing literature on a descriptive level showing that WE lead to higher learning-relevant motivation ( Paas et al., 2005 ; Van Harsel et al., 2019 ). Additionally, both experimental groups rated the usefulness of the WE as high and reported a positive evaluation of the WE. Therefore, we assume that even non-faded WE do not lead to over-instruction. Regarding the descriptive tendency, a larger sample might yield significant results and detect even small effects in future investigations. However, because this study also focused on comprehensive qualitative data analysis, it was not possible to evaluate a larger sample in this study.

5.3 Results on cognitive load

Finally, CL did not vary significantly across all three groups (RQ3). However, differences in extraneous CL just slightly missed significance. In descriptive values, the control group reported the highest extrinsic and lowest germane CL. The faded WE group showed the lowest extrinsic CL and a similar germane CL as the non-faded WE group. These results are consistent with Paas et al. (2003) and Renkl (2014) , reporting that WE can help to reduce the extraneous CL and, in return, lead to an increase in germane CL. Again, these differences were just above the significance level, and it would be advantageous to retest with a larger sample to detect even small effects.

Taken together, our results only partially confirm H1: the integration of WE (both faded and non-faded WE) led to a higher acquisition of application knowledge than the control group without WE, but higher factual knowledge was not found. Furthermore, higher motivation or different CL was found on a descriptive level only. The control group provided the basis for comparison with the treatment in order to investigate if there is an effect at all and, if so, how large the effect is. This is an important point to assess whether the effort of implementing WE is justified. Additionally, regarding H2, our results reveal no significant differences between the two WE conditions. We assume that the high complexity of the FA could play a role in this regard, which might be hard to handle, especially for beginners, so learners could benefit from support throughout (i.e., non-faded WE).

In addition to the limitations already mentioned, it must be noted that only one exemplary topic was investigated, and the sample only consisted of students. Since only the learning domain of the double-content WE was investigated, the exemplifying domain could also be analyzed, or further variables like motivation could be included in further studies. Furthermore, the influence of learners’ prior knowledge on learning with WE could be investigated, as studies have found that WE are particularly beneficial in the initial acquisition of cognitive skills ( Kalyuga et al., 2001 ).

6 Conclusion

Overall, the results of the current study suggest a beneficial role for WE in supporting the application of scientific observation steps. A major implication of these findings is that both faded and non-faded WE should be considered, as no general advantage of faded WE over non-faded WE was found. This information can be used to develop targeted interventions aimed at the support of scientific observation skills.

Data availability statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics statement

Ethical approval was not required for the study involving human participants in accordance with the local legislation and institutional requirements. Written informed consent to participate in this study was not required from the participants in accordance with the national legislation and the institutional requirements.

Author contributions

ML: Writing – original draft. SM: Writing – review & editing. JP: Writing – review & editing. JG: Writing – review & editing. DL: Writing – review & editing.

The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.

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.

Supplementary material

The Supplementary material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/feduc.2024.1293516/full#supplementary-material

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Keywords: digital media, worked examples, scientific observation, motivation, cognitive load

Citation: Lechner M, Moser S, Pander J, Geist J and Lewalter D (2024) Learning scientific observation with worked examples in a digital learning environment. Front. Educ . 9:1293516. doi: 10.3389/feduc.2024.1293516

Received: 13 September 2023; Accepted: 29 February 2024; Published: 18 March 2024.

Reviewed by:

Copyright © 2024 Lechner, Moser, Pander, Geist and Lewalter. 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: Miriam Lechner, [email protected]

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Observational designs for real-world evidence studies

Santosh ramesh taur.

Medical Lead, Pfizer Ltd, Mumbai Maharashtra, India

In the era of evidence-based medicine, real-world evidence (RWE) studies have opened avenues to utilize real-world data (RWD) effectively for improving clinical decision-making. However, the transformation of RWD into a meaningful RWE can only be achieved when the researcher asks the right clinical question, selects the right RWD source for variables of interest, uses the right study design, and applies the right statistical analysis. The generated RWE needs to have internal as well as external validity to be actionable. The “fit-for-purpose” observational study designs include descriptive, case–control, cross-sectional, and cohort. This article focuses on the advantages and disadvantages including the inherent bias of each study design. The RWE study decision guide has also been provided to aid the selection of appropriate study designs.

INTRODUCTION

The evolution of real-world evidence (RWE) over the past years has improved our understanding of disease characteristics as well as the safety and effectiveness of treatment in clinical practice. Well-designed RWE may complement the randomized controlled trials (RCTs) in clinical decision-making. Digitalization of health-care systems advances the availability and utilization of real-world data (RWD), such as electronic medical records, registries, and wearable devices, by researchers. The generated RWE needs to be internally valid and generalizable to an identifiable target population to be actionable.[ 1 ] Turning RWD into RWE involves the interplay of a design layer – study design appropriate for the research question; a measurement layer – transforming the patient-level data into the variables of exposure and outcome; and an analysis layer – deriving the estimate of effect.[ 1 ] We will discuss RWE studies with focus on observational designs and the selection of appropriate designs that guide investigators and reviewers of RWE.

REAL-WORLD EVIDENCE STUDY DESIGNS

RWE studies can be classified basis the assignment of intervention and requirement of the comparison group [ Figure 1 and Table 1 ].[ 2 ]

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Object name is PCR-13-12-g001.jpg

Classification of real-world evidence study designs; R – retrospective, P – prospective

The design and analysis time frame (relative to the study start or index date) of different types of real-world evidence studies

In the observational study, the participants are not preassigned to exposure or an intervention. The choice of treatments is up to patients and their physicians.

In a retrospective observational study, both exposure and outcomes have already occurred. In subsequent sections, we shall discuss in detail about 3 retrospective observational study designs, namely cross-sectional, case-control, and cohort.

Cross-sectional studies

Cross-sectional studies involve the simultaneous assessment of exposure and outcome in a single group of patients at a specific point in time. They are typically used to assess the prevalence and infer the cause of conditions/outcomes.[ 2 ] The general design involves defining the target population, deriving a sample of that population, and defining the characteristics being studied. The definition of the condition and health characteristics under study should be standardized, reproducible, and feasible to apply on a large scale.[ 3 ]

Datta et al .[ 4 ] conducted a community-based descriptive cross-sectional study among individuals aged 30 years and above in urban field practice area of a tertiary care hospital. Pretested questionnaire was used to measure the prevalence of self-reported hypertension over the past 2 years.

  • Relatively quick and inexpensive compared with RCTs[ 2 ]
  • Simultaneous assessment of a wide variety of exposures and outcomes[ 3 ]
  • The most efficient way to determine the prevalence of a condition.[ 2 ]

Disadvantages

  • As the data are collected at a single time point, a temporal relationship between the exposure and the outcome cannot be ascertained,[ 2 ] for example, if the cross-sectional study demonstrates an association between obesity and arthritis, for example, one cannot prove causal relationship whether arthritis led to obesity or the obesity caused arthritis or, whether some third factor caused them both.
  • Susceptible to selection bias, for example, patients who develop an outcome but die before the end of the study are not captured[ 2 ]
  • Unsuitable for studying rare diseases or for diseases of short duration due to low prevalence at a single point in time[ 3 ]
  • Often completed using questionnaires, which have inherent problems, including low response rates and susceptibility to various sources of bias.[ 2 ]

Case–control studies

Case–control studies are typically retrospective studies (”backward looking”) because the approach is to identify persons with the disease of interest and then look backward in time to identify factors that may have caused it [ Figure 2 ].[ 3 ] Cases are the patients with the outcome of interest, and controls are matched groups of patients without this outcome derived from the same population. The exposure to potential causal variables such as risk factors and treatment are evaluated basis of the medical history to determine causality. Case–control studies have a longitudinal or temporal aspect to the data that cross-sectional studies do not.[ 3 ] To have the consistency of the associations and risk estimates between a case-control study and other types of studies, the three key assumptions need to be met:[ 3 ]

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Object name is PCR-13-12-g002.jpg

Design of case-control study

  • cases are representative of all the cases,
  • controls are representative of persons without the disease, and
  • data are collected similarly in cases and controls.

The case–control studies help answer the research question leading to hypothesis generation.[ 2 ]

Swain et al .[ 5 ] conducted a population-based case–control study. Cases (disease) were confirmed dengue fever patients tested through IgM method and hospitalized to any public or private health facilities of the state, and controls (no disease) were from same living area of cases matched with sex and age (±2 years) with no history of dengue, chikungunya or acute febrile illness in the last 1 year. A structured validated questionnaire was used to collect information regarding exposures such as environmental practices and travel history for each consenting participant.

  • Suitable for rare outcomes or those with a long latency between exposure and disease[ 2 ]
  • Simultaneous assessment of multiple etiologic factors or potential predictors of the specific outcome[ 2 ]
  • The sample size requirement for the same effect size would be higher for a cohort study than that for a case–control study. Further, the lower prevalence of disease may result in much higher sample size of a cohort study but may not have significant impact on that for a case–control study.[ 3 ]
  • The study typically involves a single outcome[ 2 ]
  • No information about the base population from which the cases are drawn; so incidence and prevalence cannot be estimated[ 3 ]

Bias in case–control studies

Cohort studies

Cohort studies evaluate the association between a particular exposure or a risk factor and subsequent development of disease [ Figure 3 ]. They are “prospective” (”forward looking”) in that exposure or risk factor information is collected about 2 cohorts (exposed and nonexposed), and then both cohorts are followed up to ascertain the development of the outcome. In concurrent cohort studies, people with or without exposures are identified at the initiation of the study and information is collected looking forward in time to identify disease outcomes. In nonconcurrent cohort studies (retrospective), exposure information has already been collected at some point in the past and participants are surveyed in the present to determine the presence or absence of disease. It has the advantage of providing long follow-ups without waiting for time to pass to obtain disease outcomes.

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Concurrent and nonconcurrent cohort study design. Adapted from Johnson 2018[ 3 ]

Badyal et al .[ 6 ] conducted a prospective, observational, multicenter cohort study among health-care workers [HCW] (HCWs; likely to be exposed to COVID-19 cases) who were either taking or not taking prophylactic treatment ( Exposure ) for COVID-19 and assessed their COVID-19 positivity by reverse transcription-polymerase chain reaction ( Disease ).

Nested case–control study is a special study design that reduces most biases related to selection and data collection, which is typically seen in classic case–control studies, by selecting cases and controls from within a large-scale prospective cohort study. The biologic samples in the ongoing cohort study can be collected and stored until enough cases have accumulated to provide adequate study power. At that time, these baseline samples from the newly occurring cases can be thawed and measured, along with a comparison group of matched (or unmatched) controls, allowing a much more efficient approach to examining expensive or difficult-to-measure risk factors.[ 3 ]

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Immortal time bias. Adapted from Franklin et al ., 2017[ 7 ]

Nested case-cohort designs sample a priori so regardless of case status or time. This design is used for the analysis of “time to event/failure” in a large cohort where that event/failure is rare and enormous resources may be needed to ascertain covariate values. Nested case–cohort designs are more flexible than nested case–control designs when there are different choices for the time axis or several failure time outcomes.[ 3 ]

  • Find incident (new-onset) cases, rather than prevalent (existing) cases
  • Provide more information about the natural history of disease as well as direct estimates of incidence and relative risk
  • Firmly establish the temporal relationships between exposure and disease
  • Multiple disease outcomes can be studied in relationship to the exposure
  • Suitable to study a rare exposure, with exposed persons gathered at the beginning of the study.
  • Concurrent cohort design: Study duration may be exceedingly long, making difficult the maintenance of consistent study methods and enthusiasm of staff and participants
  • Follow-up of free-living populations may be expensive because people move or change their contact information and can be difficult to track
  • Requirement of large samples size and more so for rare diseases

Bias in cohort studies

HRT=Hormone therapy

Selection of right real-world evidence study design

A well-conducted RWE has both successfully replicated and predicted findings of RCTs. Transparency in the conduct and presentation of RWE studies is critical to allow reviewers to evaluate the study's validity and have confidence in their decision-making.[ 1 ]

The decision guide for selection of RWE study design (modified from the RWE Framework flow diagram developed by Xia et al . 2019[ 9 ]) has been provided in Table 4 .

Real-world evidence study decision guide

Modified from the RWE Framework flow diagram developed by Xia et al . 2019. RWE=Real-world evidence, PECO=Population, Exposure, Comparator, Outcome, PICO=Population, Intervention, Comparator, Outcome

The digitization of medical informatics has opened new avenues for the conduct of retrospective RWE studies. Observational RWE studies are less expensive and can be conducted quickly compared to the RCTs. However, observational RWE studies can be used only to find associations between risk factors and outcomes, but alone they cannot establish causation. In addition, there are inherent biases and issues of confounding associated with the observational studies impacting the “internal validity” of these studies. Well-designed and conducted observational RWE studies with careful analysis and interpretation will overcome most of these challenges and may help in hypothesis generation or complement the RCTs.

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