Nuclear Medicine Professional Development

Whats In It For Me?

How to Develop a Research Protocol

The presenter may provide this program at a chapter meeting, a scientific meeting or at a department meeting. This presentation is accompanied by a document that fully describes all details provided in this presentation.

Objectives
Upon completion of this presentation, you will be able to: Explain the theory of science Explain the theory of research List the steps involved in developing and conducting a research protocol

Introduction
Research is critical in medicine because it leads to new discoveries and can change peoples lives by improving health and wellbeing All research starts with an idea or question based on personal experiences Research shapes the world we live in by continually questioning and testing human knowledge and understanding
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Research is critical in medicine because it leads to new discoveries and can change peoples lives by improving overall health and well-being. All research begins with an idea or question based on personal experiences and ends with results that may change the way in which various ailments and disease processes are diagnosed and treated. Research shapes the world we live in by continually questioning and testing human knowledge and understanding.

Introduction
There are many ways in which humans acquire knowledge and gather information in order to solve problems Many questions are answered and problems solved based on inherited customs, traditions and experiences More complex questions may be answered through a process of logical reasoning
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

What is Reasoning?
Inductive - the process of developing generalization from specific observations Deductive - the process of developing specific predictions from general principles
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Reasoning combines experience, ones intellectual faculties and formal systems of thought. This process can be inductive or deductive. Inductive reasoning is the process of developing generalizations from specific observations, and deductive reasoning is the process of developing specific predictions from general principles. Both are useful in understanding phenomena but are limited in the ability to uncover new ideas or discoveries.

Scientific Approach
The most sophisticated method of acquiring knowledge that has been developed Combines important features of induction and deduction together with other methods to create a system of acquiring knowledge Generally more reliable than other methods Approach used most often to perform medical research
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

The scientific approach in research is the most sophisticated method of acquiring knowledge that has been developed. This approach combines important features of induction and deduction together with other methods to create a system of acquiring knowledge that is generally more reliable than other methods. It is used most often to perform medical research.

What is Science?
Knowledge or a system of knowledge covering general truths or the operation of general laws as obtained and tested through scientific method and concerned with the physical world and its phenomena The central purpose of science is to provide an objective, factual and useful account of the world in which we live
The Merriam-Webster Dictionary. Springfield, MA: Merriam-Webster, Incorporated, 1993.

Science involves the observation, identification, description, experimental investigation, and theoretical explanation of phenomenon. Science includes a series of activities usually restricted to a class of natural phenomena and involves methodology applied to an inquiry or study.

Three Domains of Science

Scientific knowledge - knowledge verified by scientific methods Scientific research - methods used for accumulation and verification of knowledge Scientific theory - systematically organized facts to explain phenomena

Science is thought to exist in three different domains. These domains are scientific knowledge, scientific research and scientific theory. Scientific knowledge is knowledge verified by scientific methods. Scientific research is a series of methods used for accumulation and verification of knowledge. Scientific theory is systematically organized facts to explain phenomena.

Functions of Science
There are two primary functions of science: Development of theory Testing of hypotheses deducted by theory Science progresses when new facts lead to new theories These facts are generally proven with research and evidence-based processes
Abramson, J. Making Sense of Data: A Self-Instruction Manual on the Interpretation of Epidemiological Data. New York, NY: Oxford University Press, 1988.

There are two primary functions of science. These include the development of theory and the testing of substantive hypotheses deducted from theory or data. Science is thought to progress when new facts lead to new theories, and these facts are generally proven with research and evidence-based processes.

What is Research?
A systematic investigation, involving the collection of information (data), to solve a problem or contribute to knowledge about a theory or practice Relies on methods and principles that will produce credible and verifiable results Research helps provide scientific understanding and solves practical problems
The Merriam-Webster Dictionary. Springfield, MA: Merriam-Webster, Incorporated, 1993.

Research is a systematic investigation, involving the collection of information (data), to solve a problem or contribute to knowledge about a theory or practice. It applies the scientific approach to the study of a question of interest and relies on methods and principles that will produce credible and verifiable results. Research helps provide scientific understanding and solves practical problems.

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Steps in Research
Identify the question or problem Conduct a literature review of the question Frame a hypothesis Develop the study design Complete the research Analyze the data Generate conclusions
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

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Identify the Question

Good or poor research is defined by the question being asked The question should be well understood, and the problem well defined Selecting a question should not be rushed If the question is hurried, proceeding in an orderly fashion may be difficult and may produce unreliable results
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

It is generally thought within the scientific community that the difference between good and poor research is the distinction between asking a good or poor question. It is very important that the question being asked is well understood and that the problem has been well defined. Selecting a research question should not be hurried and many hours may be devoted to selecting the appropriate problem to be answered. If either is not clear, proceeding in an orderly fashion may be difficult and continuing may produce unreliable results.

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Identify the Question

Sources for identifying the question or problem: Personal experiences Literature review Theories Ideas from others
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

The four most common sources for identifying the appropriate question or problem are personal experiences, review of previous research (literature review), review of theories, and ideas from others. There is a wealth of ideas one can obtain by just observing everyday occurrences. In the course of the researchers day, it is normal to experience issues that may raise questions or present problems. Posing questions prior to initiating research such as, What if this situation was approached in a different way? or What would be the outcome if a procedure was performed differently? may help define and develop a research question. In order to recognize or identify these questions, it is necessary to be aware of recurrent problems and situations that are frustrating, bothersome or do not produce reliable or good quality outcomes. It is also helpful to continually examine the way in which procedures are performed and how decisions that are made affect performance and functions. Performing a literature review is another method of developing a question. Reviewing published literature may provoke an idea or question by suggesting what areas of a topic should be explored further. Questions may also result from inconsistencies found or by the lack of published data. Continually evaluating developed theories and considering questions raised by others may also be a good source for developing questions or ideas. As situations and common practices change over time, previously proven theories may no longer produce valid outcomes. Listening to and observing problems that others have experienced may raise a question. These questions can be researched in order to produce answers and improve practices.

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Identify the Question

Criteria for evaluating the question: Significance Practicality Feasibility Interest to researcher

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Not all questions posed may be researchable although they may provoking. Generally questions that are philosophically based measured. Questions that are researchable involve variables that can measured and quantified. In some instances it may be necessary to question if this occurs.

be thought cannot be be defined, reword the

It is important to determine the questions feasibility to ensure the appropriateness of the study. Some factors that should be considered include, the duration or length of time the study will last, the time involved to enroll each subject, availability of subjects, cooperation of others, facilities and equipment, money, experience of the researcher and ethical concerns. If any of these factors pose a problem then it may be necessary to rethink the question. Another important factor is the interest level of the question or topic to the researcher. Without the researchers dedication to the topic, the study may not be successful or worthwhile. Additionally, when developing the question, the topic should promote an opportunity for growth and acquired knowledge.

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Identify the Question

Form the statement Declarative Interrogative Define the terms in the statement

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

After the question has been examined and clarified, it is necessary to convert it to a definitive statement. A good statement will serve as a guide to developing the study design. The two common types of statements used are declarative (states the problem as a declaration) or interrogative (states the problem as a question). Forming the statement helps to define the terms of the study. Once the question or problem is stated and finalized, it is necessary to understand how the question has been examined in the past.

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Literature Review
Determine what published data suggests about the question or problem Clarify the value of the question Clarify what is already known Provide sources for reference
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

When developing a research protocol the investigator must determine what the published data suggest about the question or problem being studied. This will help clarify the value of the question, what is already known or proven about the topic and which sources that may be used for reference.

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Literature Review
Primary Sources: Journal articles, books, abstracts Written by the person(s) who conducted the research Secondary Sources: Review articles that summarize research Written by someone other than primary investigator
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

There are several primary sources that may be used for a literature review. These include journal articles, books and abstracts written by the person(s) who conducted the research. Secondary sources that may be used include review articles that summarize previous research. Most source material will originate from authors or researchers other than those conducting the initial research.

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Frame a Hypothesis
The hypothesis is a statement that describes the results the researcher expects It examines relationships or differences The null hypothesis is a statement that expects no relationships or differences to exist A study should be designed to test the hypothesis or null hypothesis
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

The general purpose of a hypothesis is to guide scientific inquiries and often follows directly with the question being asked or theory being tested. It provides direction to the research design and assists in the collection, analysis and interpretation of data. A hypothesis is a tentative prediction or explanation of a relationship between two or more variables and describes the results the researcher expects to obtain. A null hypothesis is a statement that expects that no relationships or differences to exist. Research studies should be designed to test the hypothesis or null hypothesis.

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Frame a Hypothesis
The nature of the hypothesis will determine: Sample group for study Measuring instruments Study design Procedures Statistical techniques
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

The nature of the hypothesis will determine the sample group for study, measuring instruments, study design, procedures, and statistical techniques used for data analysis.

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Develop the Study Design

A study design is the researchers overall plan to obtain the answer(s) to the question being asked and the hypothesis being tested It spells out strategies to develop information that is accurate, objective and meaningful It explains methods that will be used to collect and analyze data It includes time frame to conduct study
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

The study design is the researchers overall plan to obtain the answer(s) to the hypothesis being tested. It spells out strategies for developing information that is accurate, objective, and meaningful, and explains the methods that will be used to collect and analyze data. This should also include the time frame necessary or allowed to conduct the study.

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Develop the Study Design

Questions that may assist in development: Will there be an intervention or treatment? What type of comparisons will be made? What procedures will be used to control variables? When and how many times will data be collected from research subjects? In what setting will the study take place?
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

There are several questions that should be asked to assist with study development. These include: Will there be an intervention or treatment? What type of comparisons will be made? What procedures will be used to control variables? When and how many times are data collected from research subjects? What setting will the study take place? Answers to these and similar questions will allow all pertinent information to be included and collected as part of the study. It will also help to eliminate the possibility of omitting valuable resources or other essentials needed to produce a reliable outcome.

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Develop the Study Design

Characteristics of good study design: Appropriateness of question Lack of study bias Precision of study Power of study

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Appropriateness of the research question, lack of study bias, precision of the study and power of the study to change practices are characteristics of a welldesigned study.

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Complete Research
There are several different research methods available for data collection It is important to choose one that will most accurately reflect the question being asked Research different methods and choose the most appropriate Perform research following the study design that was developed and collect appropriate data
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

There are several methods available for data collection that allows for completion of a research study. It is important to choose a method that will most accurately reflect the question being asked. It may be necessary to research different methods and choose the most appropriate one for the study being performed. It is also necessary to perform research following the study design that was developed and to collect all appropriate data.

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Complete the Research

Research methods include: Interviews and questionnaires Scales and standardized self-report measures Observational methods Biophysiologic measures Records and available data sources
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Commonly used research methods to collect data include interviews and questionnaires, scales and standardized self-report measures, observational methods, biophysiologic measures and previously documented records and available data sources. To complete a research study the developed study design should be followed. Methods and protocols should not be changed once a study is started.

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Analyze the Data

Upon completion of the study, data should be analyzed and measured for quality Instruments used should result in measures that are relevant, accurate, unbiased, sensitive, one-dimensional and efficient Measures that are physical or physiologic have a higher likelihood of success than other types

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Upon completion of the study, the data collected should be analyzed and measured for quality. An ideal measuring instrument is one that results in measures that are relevant, accurate, unbiased, sensitive, one-dimensional and efficient. Measures that are physical or physiologic have a higher likelihood of success than other types.

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Data Analysis
Quality measurements should test for: Reliability Validity Efficiency Sensitivity

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

There are several techniques that have been developed to evaluate the quality of the measurements used. These measurements should test for reliability, validity, efficiency and sensitivity. Analysis of the data may be performed quantitatively or qualitatively.

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Quantitative Data Analysis

Statistical measurements are techniques that render quantitative data meaningful and intelligible Enables researchers to reduce, summarize, organize, evaluate, interpret and communicate numerical information It may be necessary to seek the assistance of someone familiar or trained in the area of statistics to perform analysis
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Statistical measurements are techniques that render quantitative data meaningful and intelligible. These techniques enable researchers to reduce, summarize, organize, evaluate, interpret and communicate numerical information collected during a research study. In order to perform these measures appropriately and correctly, it may be necessary to seek the assistance of someone familiar or trained in the area of statistics.

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Quantitative Data Analysis

Statistics are classified as: Descriptive used to describe and synthesize data (Averages and Percentages) Inferential used to make inferences or draw conclusions about a population

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Quantitative statistics are generally classified as descriptive (used to describe and synthesize data [averages and percentages]) or inferential (used to make inferences or draw conclusions about a population).

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Quantitative Data Analysis

Types of statistical analysis: Frequency distributions Central tendency (mode, median, mean) Sampling distributions Paired t-tests ANOVA (Analysis of Variance)
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Examples of descriptive measures of statistical analysis include frequency distributions and central tendency (mode, median, mean). Inferential measures include sampling distributions, paired T-tests and ANOVA (Analysis Of Variance) analysis.

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Qualitative Data Analysis

Is used to impose some order on the body of information collected Allows for general conclusions to be reached and communicated in an understandable format Is generally described as having soft endpoints There are no uniformly accepted rules but rather generally accepted methods
Polit DF and Hungler BP. Nursing Research Principles and Methods (Fourth Edition), 1991

Qualitative analysis is used to impose some order on the body of information collected. It allows for general conclusions to be reached and communicated in an understandable format. Often this analysis is described as holistic and is usually concerned with humans and their environment and complexities. This method is sometimes described as having soft endpoints, which may include quality of life changes, ability to adapt to different environments and environmental influences on individuals. There are no uniformly accepted rules for this type of analysis. However, there are several commonly used and accepted methods.

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Generate Conclusions
Similar to the early phases of research, this may be difficult and time-consuming Involves organizing the data in order to interpret and communicate There are no specific techniques or methods but rather only simple guidelines

Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

This last stage of research involves generating the conclusions. Similar to the beginning phase, this may be difficult and time-consuming. It involves organizing the gathered and analyzed data in an orderly fashion in order to interpret and communicate the results of the study. There are no specific techniques or methods but rather only simple guidelines that may be followed.

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Generate Conclusions
Aspects of interpreting results include: Accuracy Meaning Importance Extent of generalization Implications
Polit, D. Nursing Research Principles and Methods. Philadelphia, PA: J.B. Lippincott Company, 1991.

Aspects that should be considered when interpreting the results include the accuracy, meaning and importance of the findings, the extent to which the results can be generalized and the implications that the results will have on currently accepted practices and theories. Good quality research should be developed into abstract or manuscript form and submitted to the appropriate peer reviewed journal for acceptance and publication. This is the most effective way to communicate important findings that should be adopted into daily practice.

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Conclusions
Developing, conducting and communicating a research protocol is a sophisticated and time-consuming process It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results

Developing, conducting and communicating a research protocol is a sophisticated and time-consuming process. It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results.

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