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…What’s 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.
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
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.
B. Philadelphia.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. Nursing Research Principles and Methods. 4 . PA: J. 1991. traditions and experiences More complex questions may be answered through a process of logical reasoning Polit. Lippincott Company. D.
Philadelphia. 5 . 1991. Both are useful in understanding phenomena but are limited in the ability to uncover new ideas or discoveries.B. D. This process can be inductive or deductive. one’s intellectual faculties and formal systems of thought. and deductive reasoning is the process of developing specific predictions from general principles.What is Reasoning? Inductive . PA: J.the process of developing generalization from specific observations Deductive . Nursing Research Principles and Methods. Reasoning combines experience.the process of developing specific predictions from general principles Polit. Inductive reasoning is the process of developing generalizations from specific observations. Lippincott Company.
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. 1991. 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. The scientific approach in research is the most sophisticated method of acquiring knowledge that has been developed. PA: J.B. Philadelphia. 6 . D. Lippincott Company. Nursing Research Principles and Methods. It is used most often to perform medical research.
Incorporated.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. description. and theoretical explanation of phenomenon. Science involves the observation. MA: Merriam-Webster. experimental investigation. Science includes a series of activities usually restricted to a class of natural phenomena and involves methodology applied to an inquiry or study. 7 . 1993. identification. Springfield.
scientific research and scientific theory.systematically organized facts to explain phenomena Science is thought to exist in three different domains. Scientific knowledge is knowledge verified by scientific methods.methods used for accumulation and verification of knowledge Scientific theory . Scientific research is a series of methods used for accumulation and verification of knowledge. Scientific theory is systematically organized facts to explain phenomena.Three Domains of Science Scientific knowledge . These domains are scientific knowledge. 8 .knowledge verified by scientific methods Scientific research .
Making Sense of Data: A Self-Instruction Manual on the Interpretation of Epidemiological Data. Science is thought to progress when new facts lead to new theories. New York.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. 1988. and these facts are generally proven with research and evidence-based processes. NY: Oxford University Press. There are two primary functions of science. These include the development of theory and the testing of substantive hypotheses deducted from theory or data. 9 . J.
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. Springfield. involving the collection of information (data).What is Research? A systematic investigation. MA: Merriam-Webster. Research helps provide scientific understanding and solves practical problems. Research is a systematic investigation. 10 . 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. Incorporated. 1993. involving the collection of information (data). to solve a problem or contribute to knowledge about a theory or practice.
Nursing Research Principles and Methods. D. Philadelphia. PA: J. 1991.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. Lippincott Company. 11 .B.
proceeding in an orderly fashion may be difficult and may produce unreliable results Polit.Identify the Question Good or poor research is defined by the question being asked The question should be well understood.B. 1991. Selecting a research question should not be hurried and many hours may be devoted to selecting the appropriate problem to be answered. PA: J. Lippincott Company. 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. Philadelphia. If either is not clear. D. It is very important that the question being asked is well understood and that the problem has been well defined. Nursing Research Principles and Methods. 12 . 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 continuing may produce unreliable results.
There is a wealth of ideas one can obtain by just observing everyday occurrences. Posing questions prior to initiating research such as.Identify the Question Sources for identifying the question or problem: Personal experiences Literature review Theories Ideas from others Polit. previously proven theories may no longer produce valid outcomes. Reviewing published literature may provoke an idea or question by suggesting what areas of a topic should be explored further. PA: J. it is normal to experience issues that may raise questions or present problems. Nursing Research Principles and Methods. Continually evaluating developed theories and considering questions raised by others may also be a good source for developing questions or ideas. 13 . The four most common sources for identifying the appropriate question or problem are personal experiences. Performing a literature review is another method of developing a question. In the course of the researcher’s day. 1991. “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. review of theories. It is also helpful to continually examine the way in which procedures are performed and how decisions that are made affect performance and functions. it is necessary to be aware of recurrent problems and situations that are frustrating. review of previous research (literature review). bothersome or do not produce reliable or good quality outcomes. D. Lippincott Company. In order to recognize or identify these questions. Questions may also result from inconsistencies found or by the lack of published data. Philadelphia. As situations and common practices change over time. Listening to and observing problems that others have experienced may raise a question.B. and ideas from others. These questions can be researched in order to produce answers and improve practices.
facilities and equipment. 14 . Nursing Research Principles and Methods. Another important factor is the interest level of the question or topic to the researcher. experience of the researcher and ethical concerns. If any of these factors pose a problem then it may be necessary to rethink the question. 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. availability of subjects. Not all questions posed may be researchable although they may provoking.B. the study may not be successful or worthwhile. when developing the question. Lippincott Company. Philadelphia. the topic should promote an opportunity for growth and acquired knowledge. Additionally. PA: J. cooperation of others. the duration or length of time the study will last. be thought cannot be be defined. the time involved to enroll each subject.Identify the Question Criteria for evaluating the question: Significance Practicality Feasibility Interest to researcher Polit. reword the It is important to determine the question’s feasibility to ensure the appropriateness of the study. Without the researcher’s dedication to the topic. 1991. Some factors that should be considered include. money. D.
it is necessary to understand how the question has been examined in the past. Forming the statement helps to define the terms of the study. 1991. The two common types of statements used are declarative (states the problem as a declaration) or interrogative (states the problem as a question). 15 . A good statement will serve as a guide to developing the study design. Philadelphia. PA: J. it is necessary to convert it to a definitive statement.B. D. Once the question or problem is stated and finalized. Lippincott Company.Identify the Question Form the statement Declarative Interrogative Define the terms in the statement Polit. Nursing Research Principles and Methods. After the question has been examined and clarified.
PA: J. Philadelphia. 1991. 16 . This will help clarify the value of the question. D. When developing a research protocol the investigator must determine what the published data suggest about the question or problem being studied.B.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. what is already known or proven about the topic and which sources that may be used for reference. Lippincott Company. Nursing Research Principles and Methods.
Secondary sources that may be used include review articles that summarize previous research.B. Lippincott Company. Nursing Research Principles and Methods. 1991. 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. There are several primary sources that may be used for a literature review. Philadelphia. books. PA: J.Literature Review Primary Sources: Journal articles. books and abstracts written by the person(s) who conducted the research. 17 . Most source material will originate from authors or researchers other than those conducting the initial research. D. These include journal articles.
It provides direction to the research design and assists in the collection. A null hypothesis is a statement that expects that no relationships or differences to exist.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. Lippincott Company. Research studies should be designed to test the hypothesis or null hypothesis. Philadelphia. The general purpose of a hypothesis is to guide scientific inquiries and often follows directly with the question being asked or theory being tested. 1991. 18 . PA: J. 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. Nursing Research Principles and Methods. analysis and interpretation of data.B.
and statistical techniques used for data analysis. study design. PA: J. procedures. The nature of the hypothesis will determine the sample group for study. Nursing Research Principles and Methods.B. D. Philadelphia. Lippincott Company. measuring instruments.Frame a Hypothesis The nature of the hypothesis will determine: Sample group for study Measuring instruments Study design Procedures Statistical techniques Polit. 19 . 1991.
D. This should also include the time frame necessary or allowed to conduct the study. Nursing Research Principles and Methods. and explains the methods that will be used to collect and analyze data. and meaningful. Philadelphia.Develop the Study Design A study design is the researcher’s 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. The study design is the researcher’s overall plan to obtain the answer(s) to the hypothesis being tested. PA: J. 20 . 1991. objective. Lippincott Company.B. It spells out strategies for developing 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.
It will also help to eliminate the possibility of omitting valuable resources or other essentials needed to produce a reliable outcome. D. PA: J. Lippincott Company.B. Philadelphia. 21 . 1991. 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.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. Nursing Research Principles and Methods. There are several questions that should be asked to assist with study development.
precision of the study and power of the study to change practices are characteristics of a welldesigned study. Lippincott Company. Nursing Research Principles and Methods.Develop the Study Design Characteristics of good study design: Appropriateness of question Lack of study bias Precision of study Power of study Polit. Philadelphia.B. Appropriateness of the research question. lack of study bias. 22 . D. PA: J. 1991.
Lippincott Company. It may be necessary to research different methods and choose the most appropriate one for the study being performed. D. Nursing Research Principles and Methods. It is important to choose a method that will most accurately reflect the question being asked. PA: J. 1991.B. It is also necessary to perform research following the study design that was developed and to collect all appropriate data. There are several methods available for data collection that allows for completion of a research study.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. 23 . Philadelphia.
biophysiologic measures and previously documented records and available data sources. Nursing Research Principles and Methods.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. scales and standardized self-report measures. D. To complete a research study the developed study design should be followed. Commonly used research methods to collect data include interviews and questionnaires.B. PA: J. Philadelphia. Methods and protocols should not be changed once a study is started. observational methods. 1991. 24 . Lippincott Company.
one-dimensional and efficient.B. unbiased. 1991. D. An ideal measuring instrument is one that results in measures that are relevant. 25 . the data collected should be analyzed and measured for quality.Analyze the Data Upon completion of the study. sensitive. accurate. data should be analyzed and measured for quality Instruments used should result in measures that are relevant. PA: J. unbiased. sensitive. Measures that are physical or physiologic have a higher likelihood of success than other types. Lippincott Company. accurate. one-dimensional and efficient Measures that are physical or physiologic have a higher likelihood of success than other types Polit. Upon completion of the study. Philadelphia. Nursing Research Principles and Methods.
validity. Nursing Research Principles and Methods.Data Analysis Quality measurements should test for: Reliability Validity Efficiency Sensitivity Polit. 26 . These measurements should test for reliability.B. Lippincott Company. There are several techniques that have been developed to evaluate the quality of the measurements used. Analysis of the data may be performed quantitatively or qualitatively. PA: J. 1991. D. Philadelphia. efficiency and sensitivity.
1991. 27 . Statistical measurements are techniques that render quantitative data meaningful and intelligible. interpret and communicate numerical information collected during a research study. organize. Nursing Research Principles and Methods.Quantitative Data Analysis Statistical measurements are techniques that render quantitative data meaningful and intelligible Enables researchers to reduce. D. evaluate. summarize.B. Philadelphia. summarize. 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. In order to perform these measures appropriately and correctly. Lippincott Company. it may be necessary to seek the assistance of someone familiar or trained in the area of statistics. PA: J. evaluate. These techniques enable researchers to reduce. organize.
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). PA: J. D. 1991.B. 28 . Philadelphia.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. Lippincott Company. Nursing Research Principles and Methods.
median. Nursing Research Principles and Methods. D. Inferential measures include sampling distributions.Quantitative Data Analysis Types of statistical analysis: Frequency distributions Central tendency (mode. paired T-tests and ANOVA (Analysis Of Variance) analysis. mean) Sampling distributions Paired t-tests ANOVA (Analysis of Variance) Polit. median. Lippincott Company. Philadelphia. Examples of descriptive measures of statistical analysis include frequency distributions and central tendency (mode.B. PA: J. mean). 1991. 29 .
1991 Qualitative analysis is used to impose some order on the body of information collected. 30 . which may include quality of life changes. ability to adapt to different environments and environmental influences on individuals. This method is sometimes described as having soft endpoints. Often this analysis is described as holistic and is usually concerned with humans and their environment and complexities. However. there are several commonly used and accepted methods. Nursing Research Principles and Methods (Fourth Edition).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. It allows for general conclusions to be reached and communicated in an understandable format. There are no uniformly accepted rules for this type of analysis.
It involves organizing the gathered and analyzed data in an orderly fashion in order to interpret and communicate the results of the study. Philadelphia. PA: J. 31 . Similar to the beginning phase.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. There are no specific techniques or methods but rather only simple guidelines that may be followed. Nursing Research Principles and Methods. Lippincott Company. 1991.B. D. This last stage of research involves generating the conclusions. this may be difficult and time-consuming.
meaning and importance of the findings. Philadelphia. 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. Aspects that should be considered when interpreting the results include the accuracy.B. PA: J.Generate Conclusions Aspects of interpreting results include: Accuracy Meaning Importance Extent of generalization Implications Polit. Lippincott Company. Nursing Research Principles and Methods. 1991. D. 32 . the extent to which the results can be generalized and the implications that the results will have on currently accepted practices and theories.
It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results. 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.Conclusions Developing. conducting and communicating a research protocol is a sophisticated and time-consuming process. 33 .