This course introduces the main elements of research methodology, which continue and finalize in Research Methodology II, in addition to being complemented by this program's other courses. It begins with general aspects of research to take into account in clinical studies, including measuring conditions and traits of the populations involved In the study design, the definition of internal and external validity, and the errors that may arise in a study, as well as how key aspects are summarized from ethical and legal points of view. Addressed next is the approach to the research question that defines, in the most specific manner possible, the issue under investigation following the PICO Process. The hypothesis to validate and the general and specific research objectives are defined. Subsequent to this are introductions to study design, measurements of frequency, and association of impact. The definition is given for the set of variables that permits meeting the established objectives and preparing a data collection notebook. Next, students are introduced to a first descriptive analysis, grouping or reducing data, categorizing variables, then defining the confusion factors or modifiers of the effect or interaction. First, a crude analysis is made from the data being subjected afterwards to a stratified analysis. The main methods for presenting research results are described. Finally, students are shown basic epidemiological concepts and their applications in clinical practice.
Competencies and learning outcomes
- Demonstrate systematic competence in the field of medicine, and mastery of the research skills and methods associated with that field.
- Demonstrate the ability to conceive, design, put into practice, and adopt a substantial research process.
- Contribute with original research that extends the frontiers of knowledge by developing a substantial body that merits referenced national or international publication.
- Ability to critically analyze, evaluate, and synthesize new and complex ideas.
- Know how to communicate with peers, the academic community as a whole, and society in general about their areas of expertise.
- Be able to promote, within academic and professional contexts, technological, social, or cultural advancement in a society based on knowledge.
- Access scientific literature, databases, documentary sources, and high-level information existing about clinical medicine and related areas.
- Design and plan a project that addresses the problem to research to be submitted for evaluation by ethics committees, as well as by research evaluation committees and research funding committees.
- Compile, sort, and classify research data and material, whether in the form of documents, medical records, questionnaires, experimental test results, etc.
- Communicate results and disseminate the knowledge generated to health care professionals, as well as non-specialized audiences, using written, oral, and graphic means.
- Understand methodology in clinical decision making. Clinical practice guidelines. Levels of scientific evidence.
- Understand the value of additional tests in clinical diagnosis. Indicators of validity and utility.
- Understand the meanings of the terms efficacy, effectiveness, and efficiency in therapeutic interventions.
- Enter and import data using Excel, SigmaPlot, SPSS, and/or similar programs.
- Represent data at publication-quality levels
- Perform critical readings of works, articles, or projects that use health questionnaires or scales, determining their proper use.
- Know how to validate a health scale or questionnaire.
- Discriminate between various statistics to determine the reliability, consistency, and validity of a health scale or questionnaire.
- Be able to describe before a specialized forum how to addresses the construction and validation of a health scale or questionnaire.
- Handle with ease and on an expert level the most important information search tools available today in health sciences, from commercial databases to different types of search tools available on the Internet.
- Attain the knowledge and abilities necessary for preparing and presenting R&D project financing requests in addition to the dissemination of results thereof.
- Ability to communicate research results effectively.
- Ability to inform, educate, monitor, and maintain effective communication (including the use of technology) with patients, family members, and social groups, including those with communication difficulties.
- Be able to participate in specific advanced research meetings.
Objectives (Learning outcomes)
- The student should be able to describe the methodological foundations of clinical research and are key elements are key to such research as well as the conditions of a measure and the traits of the populations involved in the design of the study
- Be able to define the concepts of internal and external validity and errors that may appear in a study
- Recognize the possible sources of variety in that study and how they can be avoided and measured
- The student should be able to define and recognize the different types of research that has dealt with a study and explain the possibilities of strengthening it
- The student must be able to define it, noted its usefulness and application. Define the sources of variability in the clinical observations and the way of measuring the observed
- Categorize and define the types of variables used in the measurement of clinical observations.
- Define the features of the diagnostic tests used in clinic with respect to its value to increase the diagnostic presumption and how to calculate them
- Characterize the different ways to address prevention in clinical and international recommendations on quality in the prevention studies
- Define the scientific quality of each type of study used in clinical research. Estimating the prognosis quality, noted the useful types of study to analyse the forecasts and the analysis of the rates
- Learn to evaluate the quality of a therapeutic indication by means of different types of studies (clinical trial, etc).
- Assess the quality of a research study applied to a therapeutic indication whether to measure efficiency, effectiveness or efficiency
- Learn to quantify the uncertainty and risk that is assumed in the conditions of a particular study
- Solve examples of problems related to clinical epidemiology (discrepancy in the use of diagnostic tests, interpret therapeutic targets, etc.
- The student must be able to define the concept of evidence-based medicine and noted the phases that Sackett has defined for application in clinical practice.
- Define and explain the sources of variability in clinical practice
- List the features of the traditional clinical practice and which would have a new model of evidence-based practice
- Characterize sources of scientific evidence and how to assess their quality in them.
- Define the usefulness of evidence-based medicine
- Define what ia database is and to characterize the most used (Medline, Imbase and Cochrane Librery
- Explain how to solve a clinical question through a literature search, pointing out the three stages which includes
- Tell what forms of searches are the most used and its scope
- Know what type of literature is the relevant
- Reference databases to use types and its main characteristics
- The student must be able to define and characterize the sections that comprise a research proposal
- Define and characterize the ten key sections comprising a research proposal that would be: a. problem to investigate, b-reasoning of the project c-hypotheses and objectives, d.-the study subjects. e stratification in the f Studio-Variables of the study g-h information management-Plan analysis, i.-j Action Plan-implementation and applicability
- The student must be able to define what is the design of a research project, also should characterize and recognize their different types, whether they are descriptive as analytical and within them characterize, define and recognize the different types.
- The student must know to define a study concepts such as: population, sampling frame, unit and unit of analysis, samples and the sampling design.
- It must be able of defining needs to be covered to get a valid sample
- Characterize the different types of sampling, grouped in probabilistic and non-probabilistic
- Explain how to create a simple random sample
- Recounting how a sample size is estimated
- Explain the advantages of systematic sampling versus simple random
- Define what is the scope of a study, the subjects of the same and what would be the criteria of inclusion and exclusion cases on it.
- The student must learn to manage a database result in a research study.
- Characterize the same variables, numeric or categorical and recognize its potential inconsistencies
- Perform a descriptive analysis of the data from a study
- Characterize all continuous variables as well as the factors of confusion and interaction
- A crude analysis of the data and then perform a stratified analysis
- Point out the characteristics of types of analysis (such as the stratified of tablecloth, logistic regression, multivariate analysis
- Argimón Pallás, José M. Jiménez Villa, José. "Métodos de investigación clínica y epidemiológica". Madrid [etc.] Elsevier cop. 2004.
- Bermejo Fraire, Begoña. "Epidemiología clínica aplicada a la toma de decisiones en medicina". Pamplona Gobierno de Navarra, Departamento de Salud 2001.
- Burgos Rodríguez, R. / Chicharro Molero, J.A. / Bobenrieth Astete, Manuel Alejandro. "Metodología de investigación y escritura científica en clínica". Granada Escuela Andaluza de Salud Pública 1994.
- Cegarra Sánchez, José. "Metodología de la investigación científica y tecnológica [recurso electronico] /". Madrid : Ediciones Díaz de Santos, 2004.
- Fletcher, Robert H. Fletcher, Suzanne W. / Wagner, Edwar H. "Epidemiología clínica aspectos fundamentales". Barcelona [etc.] Masson William and Wilkins España 1998.
- Lakatos, Imre. Worall, John ed. / Currie, Gregory ed. "La metodología de los programas de investigación científica". Madrid Alianza 1993.
- Ráfales Lamarca, Ernesto J. "Metodología de la investigación técnico-científica". Madrid Rubiños-1860 D.L. 1993.
- Sackett, David L. Haynes, R. Brian / Tugwell, Peter. "Epidemiología clínica una ciencia básica para la medicina clínica". Madrid Díaz de Santos D.L. 1989.
- Valor Yébenes, Juan Antonio. "Metodología de la investigación científica". Madrid Biblioteca Nueva 2000.
- Víctor Patricio Díaz Narváez. "Metodología De La Investigación Científica Y Bioestadística: Para Médicos, Odontólogos Y Estudiantes De Ciencias De La Salud. 2ª Edición, 2009". Ril Editores - Chile.
Methodology and grading
- Cooperative learning: Develop active learning through cooperative working strategies among students and promote shared responsibility to reach group goals.
- Learning agreement: Develop active learning through an agreement between the teacher and the student containing commitments for what will be learned, how monitoring will take place for that learning, the set period of time, and the evaluation criteria.
- Project-based learning: Realization of a project to solve a problem, applying acquired learning and promoting abilities related to planning, design, performing activities, and reaching conclusions.
- To assess the subject will take into account the participation in the following activities:
1. Test exam: A questionnaire of questions 1 to 3 units, which must answer a certain day, throughout the day.
2. Delivery of task guided and reasoned questions that indicate the professor of the subject in relation to a text. The maximum length must be 250 words. The task will take to the blog of the asingnatura at least one week before the date of deadline.
3. Delivery of task of processing of data with the statistical program SPSS, based on unit 4.
Participation in the Forum of questions is not mandatory and is not assessable.
The evaluation will consist of 60% exam mark, 20% the task of methodology and 20% the task of SPSS.