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The Physician and Research

The Filipino Physician Today, A Practical Guide to Holistic Medicine Many physicians are intimidated by research possibly because of a misconception that it requires huge funding, elaborate facilities and familiarity with areas not generally within the scope of general practice. In reality, the physician has a lot of opportunity to do research while doing clinical practice. One can do research on early and undifferentiated illness or the social and behavioral aspects of clinical medicine. The Field of Research When a person observes events and tries to manipulate (only if experimentally) certain conditions to see what effects it will have, this is called inquiry. In conducting research, a scientific inquiry is employed. Research, which is a systematic and intensive process of carrying on a scientific method of analysis, has the following characteristics: It is directed towards the solution of a problem. It emphasizes the development of generalizations, principles or theories. It is based upon observable experience. It involves gathering data from primary sources. It is carefully recorded and reported. It employs carefully designed procedures to which rigorous analysis is applied. consistent and has held all things constant, he could derive a theory or paradigm from the research. Components of the Research Proposal The research proposal is the written plan of the study. It describes the whole process of the investigation that will be done and it must be clear, complete, flexible and persuasive. Preparations include technical planning of the various components, scheduling the phases of the study and writing the proposal. Parts of a Research Proposal 1. Title 2. Introduction/ background or significance of the study 3. Research question (PIOM) 4. Research hypothesis 5. Research Objectives (One) General Objective Specific Objectives 6. Review of Literature 7. Research Designs Reasons for the choice of research design Inclusion/Exclusion criteria 8. Data Collection (Step by step procedure) 9. Proposed statistical analysis Reason for choice of statistical analysis 10. Ethics / Informed Consent 11. Budget and justification 12. Bibliography 13. Appendices 1. The Research Problem This serves as the backbone of the study. It is any significant and challenging situation that requires reflective thinking. It brings into focus the nature of the research to be done. Thus, it should contain the following elements: Population subject of the study Intervention exposure that will be given Outcome endpoint of the study Methods design that will be used in the study

Research entaills observation, measurement, experimentation, good thinking and replication in order to arrive at a theory or paradigm. Observation is the systematic noting and recording of events. Measurement is the determination of the dimensions of an even, while experimentation is the systematic manipulation of certain variables to confirm that a certain prediction is true or not. Good thinking is needed to analyze the data. Conclusions made must follow from the data obtained. It should be possible a procedure to get the same results. If a researcher has been systematic,

When writing the research question, one must keep in mind the following points: a. Clinical Significance the study should be designed to improve health care. If it does not, then it is of doubtful value. A comprehensive literature search on the subject of research is a must in order to: 1) elaborate on the significance and scientific rationale of the study, 2) cite similar studies done on the subject of interest, and 3) find controversies on the subject of interest. b. Epidemiologic issues has the most appropriate methodology been used? c. Biologic question is the biologic reationale sound? Is enough known about the biology to warrant the risk (for the patient; for the investigator; for time invested) of a large-scale clinal study? The more is known about the biology of the process the smaller the risk (to both patient and investigator) in performing the study. However, remember the following points: 1) Biologic dogma is not always correct 2) Small risk (often) small gain, large risk (often) large gain 3) If we were to wait for biology to be completely understood, many important studies would be deferred. 2. The Hypothesis This is a tentative conclusion or answer to a specific question raised at the beginning of the investigation. The research hypothesis is a formal affirmative statement predicting a single research outcome. It focuses the investigation on a definite target and determines what observations or measures are to be used. There are two types of hypothesis: the null and the alternative. The null states that there is no difference between two phenomena while the alternative states that there is a difference between the two in terms of outcome. 3. The Research Objectives These are what the researcher expect to achieve, or the specific outcome he hopes would be produced by the study. The research objective,

therefore, is the solution to the research hypothesis. It is important because it: Gives indication of relevant variables to be considered in the study Guides the researcher in the choice of research design Tells the researcher what date to collect Helps in planning analysis of results The General Objective is the overall purpose of research. It is derived from a statement of broad problems and hypothesis. This is done by transforming the problem statement from a question form to a declarative form. The Specific Objective is the particular outcome of the study. It must meet the purpose of the study, that is, it should enable the researcher to achieve the general objective. It must be written clearly and expressed in measurable terms. 4. The Review of Literature This is a summary of reports of various studies. Previous researches closely related to the problem under investigation are cited considering the various elements such as design, population, variables, faults and recommendations. The similarities and differences related to the existing study are analyzed. The related literature must be as recent as possible, relevant, objective and unbiased. This part will serve as a valuable guide for defining the problem, recognizing its significance, suggesting promising data-gathering device, appropriate study design and sources of data. It will also help avoid duplication of past researches. 5. The Research Methods These include the subjects, design of the study, data collection strategy and manner of data analysis. a) subjects The eligible subjects should be specified. This could be done by identifying the target population including their clinical and demographic characteristics, temporal and geographic characteristics and inclusion / exclusion criteria. After identifying the subjects, the sampling method should be

determined. Describe what methods will be used to recruit the subjects. Documentation is important so that the study will be feasible and that there will be no ethical problems. Informed consent must be present. Indicate how they will be allocated to the study groups. Random allocation is the assignment of subjects to treatment conditions in a manner determined by chance alone. The goal of randomization is to minimize the probability that groups receiving different interventions will be comparable. It is important to describe the randomization technique in detail. b) Design Refer to lectures on types of studies. Descriptive studies case report, case series, cross-sectional studies, cohort studies, case control studies Experimental studies quasiexperimental, randomized control trial Secondary study design metaanalysis, economic analysis, c) Data collection data may be categorized into primary and secondary data. Primary data is obtained by the investigator to answer his research problem. This may be done through interviews, physical examination or observation. Secondary data is obtained from already existing data collected by some other people for purposes which are different from that of the investigator. Various sources of data include census, registries, logbooks, reports, reviews and statistics from different agencies. Desired qualities of data should include the following : 1) Timeliness interval between the date of occurrence of the different events and the time when the data is used. 2) Completeness comprehensiveness as to coverage and the accomplishment of the form. 3) Accuracy closeness of the measurement and completeness in accomplishing the form. 4) Precision repeatability or consistency of the information 5) Relevance significance to other users. Methods of data collection include surveys, interviews, observation or tests. A survey involves gathering data from a large number of cases at a particular time. The interview is a way of gathering data through the senses. A

test is done by conducting trials and experiments. Instruments used in data collection Questionnaire, rating scale Criteria for instrument selectionreliability, validity, sensitivity, interpretability Data presentation can be done through narrative or textual method, tabular form or graphical presentation. In the narrative or textual method, the data is simply narrated. Tables may be used for easier understanding. Graphs are more effective tools in delivering specific messages. They may be in the form of a bar graph, pie chart, histogram, line diagram, scatterpoints or frequency polygon. d) Data Processing this is a series of steps undertaken to put the collected data information in a form that is suitable for statistical analysis. Steps include editing, encoding, creating a data file and summarizing. Editing is examining the completed forms or questionnaires for errors Coding is converting the data into numbers or symbols that can be counted or tabulated Creating a data file is storing data usually in the computer Summarizing is making cross tabulations and master tables for easier interpretation e) Data Analysis this is the computation of desired indicators stipulated in the objectives. These are the procedures for recording, storing and reducing data and assessing data quality through the use of statistical analysis. Statistical analysis could either be descriptive or inferential. Descriptive statistics looks into the variables one at a time. It includes the mean, median, range and proportion. It summarizes important features of numerical data, characterizes subjects, determines distribution or variables and assesses assumptions for statistical tests.

Inferential statistics looks at associations among two or more variables. It estimates pattern and strength of association among variables and test hypotheses. 6. Budget The following guide can help in making the budget of the research proposal: a) include only what is needed for your project b) Review your methods and materials so as not to miss anything c) Review your budget items for correct calculate ons, d) Allow for inflation and price increase. To calculate the budget cost, one must include the following: personnel, laboratories or venue used, services, materials and equipment, questionnaire preparation, maintenance and operation cost, transportation, data management, subject identification cost, publication expenses and administrative cost. ETHICS IN RESEARCH Look up the following: 1. Informed consent respect for the person must be instituted and of utmost importance. In the recruitment of volunts for the research, they should be made to understand the benefits of the procedures employed, risks involved and the demands that may be made upon them. If they are minors or mentally incapacitated,, the consent of parents or guardians is necessary. The freedom to participate or decline is basic, and it includes also the freedom to withdraw from the study. Coercion and exploitation of the participants is an unethical practice. 2. Autonomy ones privacy must not be invaded. Concealed observers, cameras, microphones or use of private correspondence without the subjects knowledge and permission are invasions of privacy. If these practices are to be done, the researcher must inform the participants and explain the reason for such. 3. Confidentiality The researcher must hold all information about the subject in strict confidence disguising the participants identity in all records and reports. 4. Non-maleficence One must not do any harm. There must be protection

from exposure to physical and mental harm and danger. In using treatment that may have a temporary or permanent effect on the subjects, the researcher must take all precautions to protect their well being. 5. Knowledge of Outcome The subject has a right to receive an explanation for the reasons for the experimental procedures and the results of the investigation. This may be done orally or in writing or by informing him of the issue of the journal in which the report was published. 6. Beneficence The research should be for the good of the majority. 7. Justice Exclusion of subjects who develop adverse effects must be done. Equal distribution of benefits is given. 8. Honesty in the presentation of the results, the researcher should not tamper with the data. 9. Respect Participants must be treated as persons and not objects. Respect for local beliefs and values must be present.