How to Develop a Research Protocol

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1 How to Develop a Research Protocol Goals & Objectives: To explain the theory of science To explain the theory of research To list the steps involved in developing and conducting a research protocol Outline: Introduction What is reasoning? Scientific approach What is science? Three domains of science Function of science What is research? Steps in research (Scientific Approach) Identify the question or problem Sources used Criteria for evaluation Conduct a literature review of question Primary and secondary sources Frame a hypothesis Develop the study design Questions for development Characteristics of a good study design Complete the research Research methods Analyze the data Quality measurements Quantitative analysis Qualitative analysis Generate conclusions Aspects of interpreting results Conclusion Introduction Medical research is important 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 one s experiences and ends with a conclusion 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.

2 2 What is reasoning? 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 one s inherent customs, traditions and experiences. More complex questions may be answered through a process of logical reasoning. This combines experience, one s intellectual faculties and formal systems of thought. This process of reasoning 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 scientific approach is the most sophisticated method of acquiring knowledge that humans have developed. It 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. This approach is used most often to perform medical research. What Is Science? Science is knowledge or a system of principles covering general truths or the operation of general laws as obtained and tested through scientific method. Science is 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. Three domains of science 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 a domain of systematically organized facts to explain phenomena. Function of science 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. What Is Research? 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

3 3 credible and verifiable results. Research helps provide scientific understanding and solves practical problems. Steps In Research (Scientific Approach) Identify the question or problem Conduct a literature review of question Frame a hypothesis Develop the study design Complete the research Analyze the data Generate conclusions Identify the question or problem It is thought 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 question should not be hurried and many hours may be devoted in choosing 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. Sources used to identify the question The four most common sources for finding a question or problem include: - one s experiences - a review of previous research (literature review) - a review of theories - ideas from others There is a wealth of ideas one can obtain by just observing every day occurrences. In the course of one s day it is normal to experience issues that may raise questions or present problems. Rethinking or asking the following questions may help define and develop a research question: - What if this situation was approached in a different way? - What would be the outcome if a procedure was performed differently? 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 also a good method of developing a question. Picking a topic of interest and examining what research has been performed previously may be an effective way to do this. Reviewing published literature may provoke an idea or question by suggesting what areas of a topic should be explored further. Questions may also be raised by the inconsistencies that are suggested or by the lack of what exists about a topic in the published literature.

4 4 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. Criteria for evaluating the question When developing the question that is going to be researched, it is necessary to ensure that the question being asked has significance, is researchable, has feasibility and is of interest to the researcher. It is important that the research being performed has an outcome that is meaningful. Some questions that should be considered are: - Is the problem an important one? - Will the results change current practice? - Will the results lead to better applications, procedures or outcomes? - Will the findings broaden knowledge or understanding? - Will the results have relevance to the topic? Asking these questions may help establish the usefulness of the possible research question being asked. Not all questions posed may be researchable although they may be thought-provoking. Generally questions that are philosophy based cannot be measured. Questions that are researchable involve variables that can be defined, measured and quantified. In some instances it may be necessary to reword the question if this occurs. Ensuring that a question is feasible is important to determine the appropriateness of the study. Some factors that should be considered are time or timing, availability of subjects, cooperation of others, facilities and equipment, money, experience of the researcher and ethical concerns. If any or all of these factors pose a problem, then it may be necessary to rethink the question. The interest of the question or topic to the researcher is an important factor as well. If the researcher is not dedicated to the study, chances are it will not be successful or worthwhile. When developing the question, the topic should not only be of interest to the researcher but should also promote and opportunity for growth and acquired knowledge. Once 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 is where the terms of the study will be defined as well. After the question or problem is stated and finalized, it is necessary to then understand how the question has been examined in the past.

5 5 Conduct a literature review of the question When developing a research protocol it is necessary to determine what previous research is stated about the question or problem being studied. This will help clarify the value of the question, as well as what is already known or proven about the topic. It will also provide information on various research approaches used previously and sources that may be used for reference. Primary and secondary sources There are several primary sources that may be used for a literature review. These include journals 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. Someone other than the primary researchers generally has written these sources. Frame a hypothesis The general purpose of a hypothesis is to help guide scientific inquiries and often follows directly with the question being asked or theory being tested. It helps provide direction to the research design and assists in the collection, analysis and interpretation of data. A hypothesis is a tentative prediction or explanation of relationship between two or more variables, and this statement describes the results the researcher expects to obtain. A null hypothesis is a statement that expects no relationships or differences exist. Research studies should be designed to test the hypothesis or null hypothesis. The nature of the hypothesis will help determine the sample group for study, measuring instruments, study design, procedures, and statistical techniques used for data analysis. Develop the study design The study design is the researcher s overall plan to obtain answers to the question being asked and the hypothesis being tested. It spells out strategies to develop information that are accurate, objective, and meaningful, and explains the methods that will be used to collect and analyze data. This also should include the time frame necessary or allowed to conduct the study. Questions for development There are several questions that should be asked to assist with study development. These questions 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 will data be 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. This information will also help to eliminate the possibility of omitting valuable resources or other essentials needed to produce a reliable outcome.

6 6 Characteristics of a good study design Characteristics of a study that was designed well include appropriateness of the research question, lack of study bias, precision of the study and power of the study to change practices. Complete the research There are several different research methods available for data collection that allow 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. Research methods Research methods that are commonly used to collect data include: - interviews and questionnaires - scales and standardized self-report measures - observational methods - biophysiologic measures - previously documented records and available data sources To complete a research study, the developed study design should be followed and methods and protocols should not be changed once a study is started. Analyze the data 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 chance of success than other types. Quality measurements 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. Quantitative analysis 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

7 7 measures appropriately and correctly, it may be necessary to seek the assistance of someone familiar or trained in the area of statistics. 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) 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. Qualitative analysis 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 it is described as holistic, as it is usually concerned with humans and their environment and complexities. These methods are sometimes described as soft endpoints, which may include quality of life changes, ability to adapt in 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. Generate conclusions This last stage of research involves generating the conclusions. Similar to the early phases of research, this stage 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. Aspects of interpreting results 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 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. Conclusion Developing, conducting and communicating a research protocol is a sophisticated and timeconsuming process. It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results.

8 8 References: 1. Abramson, J. Making Sense of Data A Self-Instructional Manual on the Interpretation of Epidemiological Data. New York, NY: Oxford University Press, Best, J. Research and Education. Boston, MA: Allyn and Bacon, Elmes, D. Research Methods in Psychology. St. Paul, MN: West, National Health and Medical Research Council. How to Review the Evidence: Systematic Identification and Review of the Scientific Literature. Canberra, Australia: Biotext, McMillan, J. Understanding and Evaluating Educational Research. New Jersey: Merrill, Polit, D. Nursing Research Principles and Methods (Fourth Edition). Philadelphia, PA: J.B. Lippincott Company, 1991.

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