Why Is Research Needed In Clinical Psychology?
Sabrina Sarro
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Science and Clinical Practice
- Define the clinical practice of psychology and distinguish it from the science of psychology.
- Explain how science is relevant to clinical practice.
- Define the concept of an empirically supported treatment and give some examples.
Psychology is the scientific study of behaviour and mental processes. But it is also the application of scientific research to “help people, organizations, and communities function better” (American Psychological Association, 2011). By far the most common and widely known application is the clinical practice of psychology —the diagnosis and treatment of psychological disorders and related problems.
Let us use the term clinical practice broadly to refer to the activities of clinical and counseling psychologists, school psychologists, marriage and family therapists, licensed clinical social workers, and others who work with people individually or in small groups to identify and help address their psychological problems.
It is important to consider the relationship between scientific research and clinical practice because many students are especially interested in clinical practice, perhaps even as a career. The main point is that psychological disorders and other behavioural problems are part of the natural world.
- This means that questions about their nature, causes, and consequences are empirically testable and therefore subject to scientific study.
- As with other questions about human behaviour, we cannot rely on our intuition or common sense for detailed and accurate answers.
- Consider, for example, that dozens of popular books and thousands of websites claim that adult children of alcoholics have a distinct personality profile, including low self-esteem, feelings of powerlessness, and difficulties with intimacy.
Although this sounds plausible, scientific research has demonstrated that adult children of alcoholics are no more likely to have these problems than anybody else (Lilienfeld et al., 2010). Similarly, questions about whether a particular psychotherapy is effective are empirically testable questions that can be answered by scientific research.
- If a new psychotherapy is an effective treatment for depression, then systematic observation should reveal that depressed people who receive this psychotherapy improve more than a similar group of depressed people who do not receive this psychotherapy (or who receive some alternative treatment).
- Treatments that have been shown to work in this way are called empirically supported treatments,
An empirically supported treatment is one that has been studied scientifically and shown to result in greater improvement than no treatment, a placebo, or some alternative treatment. These include many forms of psychotherapy, which can be as effective as standard drug therapies.
- Cognitive behavioural therapy. For depression, panic disorder, bulimia nervosa, and post-traumatic stress disorder.
- Exposure therapy. For post-traumatic stress disorder.
- Behavioural therapy. For depression.
- Behavioural couples therapy. For alcoholism and substance abuse.
- Exposure therapy with response prevention. For obsessive-compulsive disorder.
- Family therapy. For schizophrenia.
For a more complete list, see the following website, which is maintained by Division 12 of the American Psychological Association, the Society for Clinical Psychology:, Many in the clinical psychology community have argued that their field has not paid enough attention to scientific research—for example, by failing to use empirically supported treatments—and have suggested a variety of changes in the way clinicians are trained and treatments are evaluated and put into practice.
- Others believe that these claims are exaggerated and the suggested changes are unnecessary (Norcross, Beutler, & Levant, 2005).
- On both sides of the debate, however, there is agreement that a scientific approach to clinical psychology is essential if the goal is to diagnose and treat psychological problems based on detailed and accurate knowledge about those problems and the most effective treatments for them.
So not only is it important for scientific research in clinical psychology to continue, but it is also important for clinicians who never conduct a scientific study themselves to be scientifically literate so that they can read and evaluate new research and make treatment decisions based on the best available evidence.
- The clinical practice of psychology—the diagnosis and treatment of psychological problems—is one important application of the scientific discipline of psychology.
- Scientific research is relevant to clinical practice because it provides detailed and accurate knowledge about psychological problems and establishes whether treatments are effective.
- Discussion: Some clinicians argue that what they do is an “art form” based on intuition and personal experience and therefore cannot be evaluated scientifically. Write a paragraph about how satisfied you would be with such a clinician and why from each of three perspectives:
- a potential client of the clinician
- a judge who must decide whether to allow the clinician to testify as an expert witness in a child abuse case
- an insurance company representative who must decide whether to reimburse the clinician for his or her services
- Practice: Create a short list of questions that a client could ask a clinician to determine whether he or she pays sufficient attention to scientific research.
The diagnosis and treatment of psychological disorders and related problems. Treatments that have been shown to work through systematic observation. : Science and Clinical Practice
Contents
What is research in clinical psychology?
Clinical psychology research is a specialization within clinical research. It is the study of behavioral and mental health. In many ways, it is as important to the nation’s health and well being as medical research. In the same way that medical scientists work to understand the prevention, genesis, and spread of various diseases, clinical research psychologists conduct rigorous psychological research studies to understand, prevent, and treat the psychological conditions as it applies to individuals, couples, families, cultures, and diverse communities.
Empirical results gathered from psychological research studies guide practitioners in developing effective interventions and techniques that clinical psychologists employ – proven, reliable results that improve lives, mend troubled relationships, manage addictions, and help manage and treat a variety of other mental health issues.
Clinical psychology integrates science with practice and produces a field that encourages a robust, ongoing process of scientific discovery and clinical application, Role Clinical research psychologists integrate the science of psychology and the treatment of complex human problems with the intention of promoting change.
The four main goals of psychology are to describe, explain, predict and control the behavior and mental processes of others. This approach allows clinical researchers to accomplish their goals for their psychological studies, which is to describe, explain, predict, and in some cases, influence processes or behaviors of the mind.
The ultimate goal of scientific research in psychology is to illustrate behaviors and give details on why they take place. Clinical psychologists work largely in health and social care settings including hospitals, health centers, community mental health teams, Child and Adolescent Mental Health Services (CAMHS) and social services.
- They often work as part of a team with other health professionals and practitioners.
- Salary and Education The mean annual salary of a clinical psychologist is about $69,000, however, those with doctoral degrees can earn salaries of $116,343 or more.
- This industry is highly stable and growing, as psychological research becomes more important to various other industries.
If you want to become a clinical research psychologist, you need a master’s or doctorate degree. In these graduate programs, you will be trained at how to navigate this large body of research. In addition, many clinical psychology students are able to make significant contributions to the field during their education by assisting in labs and learning valuable field knowledge.
- Research in clinical psychology is vast, containing hundreds if not thousands of topics.
- By engaging in research, we are investigating new ways to understand the human mind, and developing solutions to enrich the lives of all others, many students create current and up-to-date with psychology research at universities and research labs across the world.
Take courses from CCRPS and learn more on how to become a clinical research professional. Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Why do we need research methods in psychology?
Introduction – Psychology is an empirical science, one dealing with the prediction of behavior in humans and animals. Conducting empirical research focused on predicting behavior requires the use of research methods. Research methods are the practical tools and techniques psychologists employ to scientifically investigate research questions.
- Once a hypothesis is formulated, research methodology allows a researcher to execute a study designed to answer such testable questions through manipulating and measuring relevant variables.
- Research methods in psychology are broad and varied, and their use allows psychologists to appropriately test theories in search of demonstrable cause and effect relationships.
These methods lie along a continuum from more passive approaches (e.g., observation) to active interventions (e.g., experimentation) designed to explain why organisms behave as they do. In general, research methods help investigators act ethically, reduce sources of bias that can affect interpretation, rule out alternative explanations for results, demonstrate that findings are valid and reliable, and advance theory development.
- Research methods are distinguishable by approach (qualitative or quantitative), how the data are sampled, and the type of equipment, if any, relied on for data collection.
- Although all psychologists are likely to possess a shared understanding of basic research methodology (particularly, for example, the need for randomization), different subfields within psychology are apt to rely on distinct methods designed to examine different levels of behavior.
Traditionally, research methods in psychology have relied as much as possible on objective or quantitative approaches, where a favored hypothesis is pitted against some alternative account. Relevant designs incorporate control groups in order to verify predicted relationships by comparing them against competing possible outcomes.
- Increasingly, however, psychologists are becoming open to exploring more subjective or qualitative approaches where participants’ own perspectives, beliefs, and reports constitute acceptable data.
- Many psychologists now employ a mix of quantitative and qualitative methods in their research efforts.
- The first section of this bibliography introduces general overviews, textbooks, and reference works detailing research methods used in experimental, developmental, social, and personality psychology.
Attention is also paid to works examining teaching research methods, selective journals that publish articles presenting novel methods, as well as methodological controversies. The bibliography’s remaining sections examine particular methodological approaches, many of which include studies illustrating innovative or modified methods.
What is clinical research and its importance?
What is clinical research? – Clinical research is the study of health and illness in people. There are two main types of clinical research: observational studies and clinical trials. Read and share this infographic (PDF, 317K) to learn why researchers do different kinds of clinical studies. Observational studies monitor people in normal settings. Researchers gather information from people and compare changes over time. For example, researchers may ask a group of older adults about their exercise habits and provide monthly memory tests for a year to learn how physical activity is associated with cognitive health,
Observational studies do not test a medical intervention, such as a drug or device, but may help identify new treatments or prevention strategies to test in clinical trials. Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people.
Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments. Other aims of clinical research include:
- Testing ways to diagnose a disease early, sometimes before there are symptoms
- Finding approaches to prevent a health problem, including in people who are healthy but at increased risk of developing a disease
- Improving quality of life for people living with a life-threatening disease or chronic health problem
- Studying the role of caregivers or support groups
Learn more about clinical research from MedlinePlus and ClinicalTrials.gov,
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What is scope of research in clinical psychology?
Problems addressed – The specialty of clinical psychology addresses behavioral and mental health issues faced by individuals across the lifespan including:
- Adjustment issues and traumatic stress reactions Emotional and psychological problems, including serious mental illness and crisis intervention Interpersonal or social problems and dysfunction Behavioral problems including substance abuse and dependence Intellectual, cognitive, and neurological conditions
What is the purpose of research?
The purpose of research is to enhance society by advancing knowledge through scientific theories, concepts and ideas. A research purpose is met through forming hypotheses, collecting data, analysing, etc. It summarizes the research study’s specific topic and goals, providing readers with an accurate, concrete understanding of the findings, the purpose of research and its characteristics.
The research purpose should be Specific and precise – not general, broad or obscure.It should be defined concisely (within one or two sentences)The research goal should be apparent. It should not be vague, ambiguous or confusing to the readers.All the statements should be Goal-oriented and also stated in terms of desired outcomes.
Example: Research on the effect of learning an additional language on children United College of Engineering and Research Here are some key points to remember for the purpose of research and its characteristics.
What is the main goal of clinical research?
Ethical guidelines – The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who take part in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patients in clinical trials.
What are two benefits of clinical research?
What are the Benefits of a Clinical Trial? –
You may get a new treatment for a disease before it is available to everyone. You play a more active role in your own health care. Researchers may provide you with medical care and more frequent health check-ups as part of your treatment. You may have the chance to help others get a better treatment for their health problems in the future. You may be able to get information about support groups and resources.
What is the difference between research psychology and clinical psychology?
Core Differences – The main difference between research psychology and applied psychology is that the main function of a research psychologist is to conduct experiments, psychological research studies, and observational studies. While on the other hand, applied psychologists applies psychological theories, principles, concepts, techniques, strategies, approaches, and methods from their branches of psychology (i.e.
- Sports, family, health, social, school, etc.) to their practices.
- In other words, an applied psychologist uses the psychological resources available to him or her to treat clients and patients experiencing psychological disorders, mental illnesses, adjustment disorders, and emotional distress.
- Every practicing psychologist uses applied psychology.
Also, research psychologist typically conduct their experiments in research laboratories with participants, while applied psychologist treat clients in clinics, mental health hospitals, social service agencies, schools, etc. They also teach at universities and colleges.
What are the 3 main purposes of research?
Purposes of Research: Exploratory, Descriptive & Explanatory.
Are there three main purposes of research?
Social Research Methods/Research Design – Wikibooks, open books for an open world
- This chapter provides a general introduction to research design by examining several issues: The main purposes of social research Units of analysis How to design a research project The elements of research proposals
- Measurement
- Three Purposes of Research
Social research can serve a variety of purposes. Three of the most influential and common purposes of research are exploration, description and explanation. Exploration involves familiarizing a researcher with a topic. Exploration satisfies the researcher’s curiosity and desire for improved understanding.
Exploration tests the feasibility of undertaking a more extensive study. Exploration helps develop the methods that will be used in a study. Description involves describing situations and events through scientific observation. Scientific descriptions are typically more accurate and precise than causal ones.
For example, the U.S. Census uses descriptive social research in its examination of characteristics of the U.S. population. Explanation involves answering the questions of what, where, when, and how. Explanatory studies answer questions of why. For example, an explanatory analysis of the 2002 General Social Survey (GSS) data indicates that 38 percent of men and 30 percent of women said marijuana should be legalized, while 55 percent of liberals and 27 percent of conservatives said the same.
Idiographic explanation – a “full”, detailed, in-depth understanding of a case; for practical reasons, only a few subjects are studied in this way. An idiographic explanation of the marijuana legalization survey would involve a more conclusive list of factors that could influence a person’s viewpoints on this issue. Therefore, an idiographic explanation would need to consider several factors, such as information from parents and previous experiences, not just political orientation.
Nomothetic explanation – a generalized understanding of a given case, with the goal of finding new factors that can account for many of the variations in a given phenomenon; is applicable to many subjects. Regarding the survey mentioned above dealing with people’s stances on marijuana legalization, a nomothetic explanation may simply suggest that political orientation is the main driving force behind people’s differing opinions on this issue. Hypotheses are not required in nomothetic research.
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- There are three main criteria for nomothetic causal relationships in social research:
- 1) the variables must be correlated 2) the variables are nonspurious
- 3) the cause takes place before the effect
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- Correlation – an empirical relationship between two variables such that changes in one are associated with changes in the other, or particular attributes in one are associated with particular attributes in the other.
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- Spurious relationship – a coincidental statistical correlation between two variables shown to be caused by some third variable. For example, increased ice cream consumption is related to the crime rate rise. But this relationship is caused by a third variable, summertime yielding hot weather and closed schools. Therefore, for a causal relationship, variables must be nonspurious
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- False criteria for nomothetic causality:
- Complete causation – proper nomothetic explanation is probabilistic and does not explain every single case.
- Exceptional cases – exceptions do not disprove nomothetic explanation.
- Majority of cases – nomothetic explanation may be applicable to only a minority of cases in a given situation.
- False criteria for nomothetic causality:
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- Necessary and Sufficient Causes:
- A necessary cause represents a condition that must be present for the effect to follow. Example: It is necessary for you to take college courses in order to get a degree. Take away the courses, and the degree never follows. ***A sufficient cause represents a condition that guarantees the effect if it is present. Example: Skipping an exam would be a sufficient cause for failing it (even though there are other ways to fail it).
- Necessary and Sufficient Causes:
Units of Analysis A unit of analysis is used to classify what or whom is being studied. The classifications include individuals, aggregates, and social artifacts.
- Individuals: In social science research, individuals are the most commonly studied.
- Aggregates: can be considered groups, organizations, and social interactions.
- Social artifacts: objects, such as paintings, articles, and diaries.
- Social interactions: interactions among individuals or aggregates.
- Examples: school children(individuals); elementary schools(aggregate-groups); education (aggregate-organization); journal (artifact); class attendance (social interaction).
- Particularly concerning groups, one can derive certain characteristics of a social group by observing the behaviors of individual members. (note: street gangs can imply all gangs/social groups and can be specified by city, sizes, locations, etc.) Organizations can be generalized too either by grouping organizations together or segregating a single organization by itself. In the context of corporations, and individual corporation can be studied via the employees (total employment, number of ethnic minority groups), gross assets, net annual profits, etc.
- Faulty Reasoning about Units of Analysis:
- The ecological fallacy is the assumption that something learned about an ecological unit says something about the individuals making up that unit.
Example: If we found that suicide rates are higher in Protestant countries than in Catholic ones, we could not draw the conclusion that more Protestants commit suicide than Catholics; this would be an ecological fallacy.
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- Reductionism involves attempts to explain a particular phenomenon in terms of limited and/or lower-order concepts.
- Example: For many social scientists, the field of sociobiology (social behavior can be explained solely in terms of genetic characteristics and behavior) is too limited and is an example of reductionism.
- The Time Dimension
- Cross Sectional Study : a study based on observations representing a single point in time; a cross section of a population. Example-The amount of people who registered to vote
- Longitudinal Study : a study based on data that is collected at several different times. Example- The Tuskegee Experiment
- There are three types of longitudinal studies:
- Trend Study : A type of longitudinal study in which a given characteristic of some population is monitored over time. Example: The series of Gallup Polls showing the electorate’s preferences for political campaign, even though different samples were interviewed at each point
- Cohort Study : A study in which some specific subpopulation, or cohort, is studied over time, although data may be collected from different members in each set of observations. Example: A study on the occupational history of the class of 1970 in which questionnaires were sent every five years
- Panel Study : A type of longitudinal study, in which data are collected from the same set of people (the sample or panel) at several points in time
Longitudinal studies do not always provide a feasible or practical means of studying processes that take place over time. Sometimes cross sectional-data can be used
- -to imply processes over time on the basis of simple logic -to make logical inferences whenever the time order of variables is clear
- -ask individuals to report their past behaviors -cohort analysis to infer processes over time
- How to Design a Research Project
- Steps for designing a research project: 1) Define the purpose of your project (exploratory, descriptive, or explanatory?) 2) Specify the meaning of each concept being studied 3) Select a research method 4) Determine how you will measure the results 5) Determine the unit of analysis 6) Collect empirical data 7) Process the data 8) Analyze the data 9) Report your findings
The problem with a simple definition: A real definition does not exist (fallacy of reification), as it mistakes our theoretical construct for a real entity. A nominal (conceptual) definition is one that is simply assigned to a term without any claim that the definition represents a “real” entity.
- The problem with an advanced definition: Some conceptual accuracy is lost at every step along the way.
- The meaning of measures are also highly contextual.
Conceptualization Once you’ve decided on a purpose for your research and the type of research you will do (exploratory, descriptive, or explanatory) the next step in designing a research project is conceptualization – the mental process whereby fuzzy, imprecise and abstract notions (concepts) are made more specific and precise.
Concepts have indicators and dimensions, An indicator is something the researcher has chosen to recognize as a reflection of a variable being studied. Example: if you’re going to study how college students feel about abortion and why, the first thing you’ll have to specify is what you mean by “the right to abortion” (because support for abortion often varies according to conditions). A dimension is a specifiable aspect of a concept. Example: dimensions of religiosity: belief, ritual, devotional, knowledge.
Operationalization Operationalization is the development of specific research procedures that will result in empirical observations representing those concepts in the real world. Example: If you decided to use a survey to study attitudes about abortion rights, part of operationalization is determining the wording of questionnaire items.
- Example of Conceptual vs Operational definitions: Weight
- Conceptual definition: a measurement of gravitational force action on an object.
- Operational definition: a result of measurement of the object on a Newton spring scale.
Choice of Research Method Each research method has its strengths and weaknesses which need to be considered when choosing what is most appropriate for your study. Example: A survey might be the most appropriate method for studying attitudes towards abortion rights.
Population and Sampling The population for a study is that group about whom we want to draw conclusions. The sample is the group you select to be representative of that population. Example: For the abortion study, your population might be college students, and your sample might be 200 Pitt students. Observations The next step is to collect empirical data.
Example: To conduct a survey on abortion, you might want to print questionnaires and mail them to a sample selected from the student body. Data Processing You next need to process your data so that it is interpretable. Example: Coding responses on the survey and transferring the information to a computer.
Analysis The next step is to interpret the data for the purpose of drawing conclusions. Example: Calculate the percentages of students who favored or opposed each of the several different versions of abortion rights. Application Determine how your research and the conclusions you made can be used. Example: Prepare or publish a written report on your findings of abortion rights attitudes and discuss how they might apply to policy goals.
Give suggestions for future research. The Research Proposal: It is often necessary to create an outline or layout of one’s research plan, in the form of a “research proposal”. This is beneficial to the researcher because it serves as an aid in planning.
- Problem/Objective: What are you planning to study, and why does it need to be studied?
- Literature Review: What previous research exists regarding this topic? What can you learn from existing research or theories pertaining to your topic? Will your study be able to improve or contribute to what already exists?
- Subjects for Study: Whom or what will you be studying, and how do you plan to get in touch with them? How will your research affect those whom you will be studying? Are you sure that your research will not be harmful to them? Is it ethical?
- Measurement: What are the key measurements (variables) pertaining to your study? How do you plan to define and measure them?
- Data-Collection Methods: How do you plan to collect data for your study? Will you use an experiment or survey, etc.?
- Analysis: What kind of analysis are you going to utilize? Are you planning to describe phenomena in detail, or will you attempt to explain the reasoning behind such phenomena?
- Schedule: What is a proposed timeline for the various stages in this project?
- Budget: Roughly, how much money do you estimate will be necessary for this project? Over the course of the project, where should the money be allocated?
- The Ethics of Research Design It is important to consider ethical conerns when you plan your research design, so that -the subject’s privacy is concerned -the subject’s well-being is protected
- It may be appropriate and necessary for your design to be reviewed by an Institutional Review Board (IRB).
- Measurement
- Measurement: careful, deliberate observations of the real world for the purpose of describing objects and events in terms of the attributes composing the variable. Social scientists measure:
- Direct observables: physical characteristics (sex, height, skin color)of a person being observed and/or interviewed
- Indirect observables: characteristics of a person as indicated by answers given in a self-administered questionnaire (age, place of birth, education)
- Constructs: level of alienation, as measured by a scale that is created by combining several direct and/or indirect observables
Levels of Measurement – all measurements in science are conducted using 4 different types of scales:
- Nominal Level -variables with attributes of exhaustiveness and mutually exclusiveness. Examples: gender, religious affiliation, college major, hair color, birthplace, nationality
- Ordinal Level -variables with attributes we can logically rank in order. Examples: socioeconomic status, level of conflict, prejudice, conservativeness, hardness
- Interval Level – variables for which the actual distance between attributes has meaning. Examples: temperature (Fahrenheit), IQ score
- Ratio Level – variables whose attributes meet the requirements of an interval measurement and has a true zero point. Examples: age, length of time, number of organizations, number of groups
- Implications: Analyses require minimum levels of measurement. And some variables can be treated as multiple levels of measurement.
Measurement Quality: While conducting an experiment or study, the quality of the measurements are very important.
- Precision – Precise measures are superior to imprecise ones. Precision is not the same as accuracy.
- Reliability – suggests that the same data would have been collected each time in repeated observations of the same phenomenon. There are different kinds of reliability: Stability, representative, and equivalence.
- Stability reliability consists of remeasuring the data over and over again in hopes of getting the same result.
- Representative reliability focuses on whether or not the data collected is the same when dealing with different “sub groups” in a certain population.
- Equivalence reliability deals with multiple indicators such as questions or coders and focuses on whether or not these different indicators can yield the same results.
- Ways to improve reliability:
- Make sure that measures capture only the concept of interest
- Increase the level (range) of measurement of the instrument
- Make use of multiple indicators
- Make use or pretests / pilot studies
- Validity -A term describing a measure that accurately reflects the concept it is intended to measure. There are four types of validity: face validity, criterion-related validity, construct validity, and content validity.
- Face validity – the quality of an indicator that makes it a reasonable measure of some variable. It relies on the reader’s common sense to make a judgement.
- Criterion-related validity – the degree to which a measure relates to some external criterion
- Construct validity – asks whether the various measures for a given concept all seem to correspond to the same thing
- Content validity – the degree to which a measure covers the concept it operationalizes
Problem: Validity and reliability can interfere with one another. Repeated measures should be taken to ensure the highest levels of both. : Social Research Methods/Research Design – Wikibooks, open books for an open world
What are the benefits of researching?
The benefits of research are: –
During a research study your condition is usually monitored more closely so any changes can be detected earlier. You may also have access to expert medical care that you otherwise would not. Staff will keep you updated on your progress and how the study is doing. This allows you to learn about your condition, and gives you more access to professionals and advice. Research improves services and treatments not just for you but also for future generations. It helps develop new tests for diagnosis, treatments and processes that could eventually help your children, or even your grandchildren. You may gain access to treatments that are not yet readily available to the general public. Taking part in research can give you a more positive outlook on any health issues. Some evidence has suggested that people who take part in research have better health outcomes no matter what treatment they receive. This is known as the ‘trial effect’. Even if the research you take part in is unsuccessful, many people feel they receive better care while the trial is running.
People take part in research for many reasons. Whatever your reason, we hope you will get involved in ours so that together we can make things better for everyone.
What is research definition in psychology?
N. the systematic effort to discover or confirm facts, to investigate a new problem or topic, or to describe events and understand relationships among variables, most often by scientific methods of observation and experimentation.
What is research in clinical practice?
On Research in Clinical Practice Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to “buy” in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain. Keywords: Clinical Research, Clinical Practice, Clinical Research Skills, Clinical Research Tools, Clinical Research Strategies Every medical practitioner is aware, I suppose, of the incompleteness and inadequateness of current medical knowledge. As a corollary, I believe he is also aware that there is a need to add to the existing knowledge, both by expanding it and by advancing it. This process of enhancing the existing knowledge is what research is expected to do. The process of research has two aspects: getting an idea is one, and verifying it is the other. Getting an idea is the creative aspect of research. There is no sure way of how to do it. The person who is in the most advantageous position to get an idea is one who is constantly observing patients, diagnosing them, and treating them. During this work his sense organs constantly feed his mind with observations in which he might notice a trend, a pattern, a sequence, an association, or something not noticed or reported earlier. This process is intuitive. The idea appears to pop into the mind suddenly, but very likely it is the result of a subconscious process of reasoning that is going on in the depths of the mind for some time. Once formed, the idea may be communicated to the peers during a talk, or in writing as a case report, a case series, or a descriptive summary report. Once the idea is outlined, it needs to be verified as to its truth or falsehood. This is the working aspect of research, requiring the making of a plan of how to test the idea; what information to collect, from whom, and how; and how to examine it to decide whether it supports the idea, contradicts it, or requires the idea to be modified. If we agree that this is how medical science has progressed in the past, and is likely to progress in the present and the future, then we need to ask who are in the most advantageous position to do it, and how they can be motivated and enabled to do it. As I said earlier, constant exposure to events can spark off a chain of reasoning leading to an idea. Therefore, doctors who treat patients daily, i.e., practitioners, are in the most advantageous position to get ideas. History of medicine provides many examples of path-breaking ideas occurring to practicing doctors. How did Jenner think of inducing cowpox in people to protect them against smallpox? This is because he had heard from milkmaids that anyone who had cowpox before hardly ever got smallpox. His mind put two and two together. The facts that both infections are caused by viruses, and that they share antigenic similarity, became known much later. Withering, who discovered the ability of digitalis to relieve heart failure; Lind, who discovered the usefulness of lemon juice for preventing scurvy; Hench, who discovered the efficacy of cortisol in relieving rheumatoid arthritis; all were practicing doctors working in the greatest laboratory of clinical research: the day-to-day world of sick people, at home, in consultation room, and in hospital. Closer at home I recall an interesting incident. I was then following up trials of prazosin (an alpha-blocker) in hypertension, which had to be temporarily suspended because a few patients in the UK had fainted after taking the first dose. One of our investigators in Nagpur, a nephrologist, responded to the trial suspension by asking me what could be the likely reason for fainting. I replied that the suspected mechanism was venous dilation and pooling of blood in the visceral area. “I see.”, he said, “If that is indeed so, why can we not use the drug to accelerate peritoneal dialysis in our patients who come from nearby towns and have to stay overnight? They are recumbent anyway, and we can monitor the CVP continuously. If we can reduce their dialysis time, we can send them home the same day.” So he assigned this subject to a postgraduate as a thesis topic and, after six months or so, showed me the results of treating 20 patients in the conventional manner and 20 after giving them a dose of prazosin one hour before the procedure. The average time for dialysis was indeed halved, and the difference was real. Here I saw a nephrologist functioning as a classical clinical pharmacologist. Of course hemodialysis became commonplace soon after this event, the need of peritoneal dialysis became rare, and prazosin was not used or studied further for this purpose. Nonetheless, the originality of the idea was impressive. I think the foregoing stories are enough to make the point that practicing doctors have the opportunity and ability to get new ideas that can change the current practice of medicine for the better. Let us now see how they can go about verifying the falsehood or truth of the ideas, and seek their acceptance by the peers. To do this, they need to be familiar with the scientific method and be trained in applying it to test different ideas. As Sir Sheldon Dudley has illustrated, it has to do with language, logic, psychology, and statistics. This is one aspect that is neglected in the education and training of doctors, both during undergraduate and postgraduate years. And this is a gap which well trained and experienced pharmaceutical physicians can fill while working with practising doctors, either in the roles of postgraduate students, study coordinators, and investigators, or in the roles of research-oriented consultants and family physicians. Any language is a system of symbols and sounds, and meanings associated with them. When we are thinking, we are quietly talking to ourselves. Words are the material with which we form and shape our ideas. So unless we acquire a reasonable mastery over language, and I do not mean only English, how can we think and communicate effectively? The ABC of communication – accuracy, brevity, clarity – are as much needed for thinking as for speaking and writing. Consider the writing part of doing research to test an idea. Be it the statement of an idea, a case report, a case series, or a summary report. Try to say or write what you mean, then ask the audience or the reader what he understood, and see how far the two are congruent. The results will surprise you. Logic is concerned with thinking flawlessly, progressing from one statement to the next, until you are able to build a general concept from a particular case or cases, or draw an inference from statements presently accepted as facts. Both these processes are critical in research, i.e., in developing and testing ideas. Concepts such as association, causation, dependence, generalization, deduction, probability, plausibility, possibility are crucial for research. Psychology also plays a role in research because human mind is its most important instrument. Knowing how it works, or can go astray, helps avoid pitfalls. Bias, prejudice, vested interests, envy, rivalry, and such attributes can influence thinking and the validity of research done. Finally, statistics or the habit of quantifying what we observe, analyze, and infer. Numbers score over words because they do not have shades of meaning. Expressing facts and inferences in numbers is at the heart of testing ideas. The best way to learn this skill is by doing, which requires a self-learning tool and, if possible, a facilitator. The tool I recommended for doctors keen to do research is a computer program called Epi Info developed by the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA. It can be used to design forms for recording data, organizing them, analyzing them, and presenting the results in tables or graphs. As regard a facilitator, I believe many pharmaceutical physicians will be happy to play this role as a part of their portfolio. Before I illustrate this with a few examples, I would like to state some beliefs which I have acquired during my industrial and academic career. First, the questions which are important to patients, their doctors, and health care payers are fairly down-to-earth and concerned with benefits, risks, and costs of health care tools: drugs, devices, diagnostics, procedures, and strategies. Second, the answer to such questions must be applicable to the broad category of patients seen in day-to-day practice, and not to a highly selective group of patients. Third, we need large but simple databases to answer the question posed, which is possible if we collect just enough data on each patient. At present we seem to collect far more data on each patient than is really necessary, at least in clinical trials. To quote Peto et al., “Most trials would be of much greater scientific value if they collected ten times less data, both at entry and during follow-up, and were therefore much larger.” Fourth, despite the availability of objective measures of illness and well-being, patients and doctors often judge the value of health care tools by what is subjectively important and relevant to them. The outcome of a health care measure may have many facets, and patients may assign different weights to them because of their job, family life, living conditions, social setting, finances, etc. Rigid trials may drown this diversity into a uniform standard, but large, in-practice databases can integrate the same diversity into meaningful results. It is just like looking at a beam of light either through a prism or a plain glass: one will split the beam into different colors; the other will show it as it appears to all. Let me take an example. You observe that the current epidemic of swine flu is leading patients to take an Ayurvedic or herbal medicine that is claimed to increase resistance to infection. If we have a database showing how many of those taking the medicine caught the infection, and how many of those who did not take the medicine caught it, we could at least have an idea about the likely benefit of taking it. If a group of practitioners could record the essential data – ID, initials, sex, age, locality, whether medication used (yes/no), and whether confirmed swine flu developed (yes/no), and any other medicine taken – in all patients they see during a defined period, we could have a meaningful answer. Suppose 20 practitioners recorded these data in 100 consecutive patients each, and found that 8 of 1100 who used the medicine got the illness (incidence 7 per 1000) whereas 19 of 900 who did not use the medicine got it (incidence 21 per 1000). Epi Info will help them record, organize, and analyze these data and conclude that the relative risk in the medication group was about a third (0.34) of that in the no-medication group, that the real relative risk could be in the range 0.15 to 0.78 (less than 1:1 or equal), that they can have 95% confidence in such a conclusion, and that the probability of these results occurring by chance is less than 1 in 100 (P < 0.01). Even if we do not know how the medicine works, at least taking it seems beneficial. If similar results are reported from various areas of the country, the validity of the conclusion will increase and perhaps prompt basic research into how the medicine might be working. Of course I have simplified the example. Even with such results, while interpreting them, one will have look for and rule out other possible causes for the difference (confounding factors). The article by Peipert and Phipps provides a lucid and concise description of what a reliable observational study should be. One way to get familiar with this type of research is to work on the three interactive tutorials provided in the Help menu of the Epi Info program (shown below). Another example that comes to my mind is that of a national survey of intestinal nematode infection which we organized in 1984 with the help of practicing pathologists. We were then about to market the drug pyrantel, but my marketing colleagues were somewhat diffident because the drug had little efficacy against whipworm. From my discussions with practicing colleagues, I had developed the idea that if the prevalence of whipworm was very low and limited to a few pockets in the country, this fact itself would help dispel my colleagues' diffidence. Enlisting the help of our field staff, we listed the pathological laboratories in their territories (total 45) into three categories – public free hospital laboratories (PFHL), public paying hospital laboratories (PPHL), and private pathology laboratories (PPL) – on the reasoning that these serviced lower, higher, and middle socioeconomic strata, respectively. Using random numbers, we selected one laboratory of each category from each territory. We requested them to gives us anonymized copies of the first 100 consecutive stool examination reports beginning the first day of the next month. We only collected data on the presence or absence of roundworm, hookworm, and whipworm eggs. We thus had 45 × 3 × 100 = 13,500 stool reports in our database. Their analysis showed that the prevalence was 16.3% for roundworm, 14.7% for hookworm, and 3.7% for whipworm. Besides, whipworm was limited to three pockets: Mumbai, Kolkata, and Kerala state. These figures helped the marketing colleagues overcome their diffidence about competing against mebendazole, and gain confidence about the single-dose convenience of pyrantel, especially for mass deworming, against the six-dose, three-day regimen of mebendazole. One more example. The prevalence of sickle cell disease (SCD) is high in the backward areas of central India. There is no cure for it except bone marrow or stem cell transplant, which is not practicable for many patients. Hydroxyurea (HU) is a drug which promotes the formation of fetal hemoglobin, reduces the polymerization of hemoglobin S, and helps reduce the incidence and intensity of ischemic crises, and, if used long-term, can improve the quality of life and delay or prevent organ damage. However, its use is not adopted as widely as it should be. This may be due to ignorance, or unspoken fears about the possible side effects of HU which is otherwise known as an anticancer drug. Some trials have shown that if used with simple hematological monitoring, the drug is well tolerated and offers considerable relief to SCD patients. Doctors practicing in the high prevalence area can form a network, use Epi Info to keep standardized records of their SCD patients, follow them up for years, and analyze the data for documenting the outcome among those who take and those who do not take HU. Such an observational, long-term study could help not only to quantify the benefits and risks of HU therapy, but also to create greater awareness of it among doctors and patients, and lead to its wider usage.
I shall rest my case for clinical research in practice with this eloquent quote: “The purpose of research is to create the knowledge essential for action to improve health. Without this knowledge, action is impossible because it has no logical or empirical* basis.
Indeed, ongoing action for health, if it does not contain an imbedded program of research, frequently becomes irrelevant, misleading or unnecessarily costly. It is for this reason that the original conception of the National Tuberculosis Program (a forerunner of many other public health programs) included the necessity of an imbedded program of research as an essential component.
“Research is an activity of perpetual questioning. While public health practice is based on consensus, standardization and systematic practice, research requires a skeptical mind, prepared to continuously evaluate and question. This questioning and evaluating, when put into a systematic framework, creates the new knowledge that is required to create and continually modify actions for health.
- This is what research is and why it is important.” * The word empirical means “based on experience”; it does not mean irrational or arbitrary as some may believe.1.
- Dudley, Sheldon,
- The Four Pillars of Wisdom.
- London: Watts & Co; 1947.2.,3.
- Peto R, Collins R, Gray R.
- Warren KS, Mosteller F, editors.
- Large scale randomized evidence: large, simple trials and overviews of trials.
Annals of the New York Academy of Sciences.1993; 703 :314–340. Doing More Good Than Harm – The Evaluation of Health Care Interventions.4. Peipert JF, Phipps MG. Observational studies. Clinical Obstetrics and Gynecology.1998; 41 :235–44.5. Gadgil SD, Kulkarni SS, Apte VV, Nanivadekar AS.
Intestinal nematode infections in India: a cross-sectional survey. Journal of Postgraduate Medicine.1984; 30 :137–43.6. Italia K, Jain D, Gattani S, et al. Hydroxyurea in sickle cell disease – a study of clinico-pharmacological efficacy in the Indian haplotype. Blood Cells and Molecular Disease.2009; 42 :25–31.7.
Enarson DA, Kennedy SM, Miller DL, Bakke P. Paris: IUATLD; 2001. Research Methods for Promotion of Lung Health – A guide to protocol development for low-income countries; p.11. : On Research in Clinical Practice
What is clinical research in simple words?
(KLIH-nih-kul REE-serch) Research in which people, or data or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.
How do you explain clinical research?
Clinical Trials – Clinical trials study the safety and effectiveness of interventions and procedures on people’s health. Interventions may include medications, radiation, foods or behaviors, such as exercise. Usually, the treatments in clinical trials are studied in a laboratory and sometimes in animals before they are studied in humans.
- Drugs or medicines
- New types of surgery
- Medical devices
- New ways of using current treatments
- New ways of changing health behaviors
- New ways to improve quality of life for sick patients