Identifying Data 2018/19
Subject (*) Clinical Research I Code 653862232
Study programme
Mestrado Universitario en Asistencia e Investigación Sanitaria (plan 2012)
Descriptors Cycle Period Year Type Credits
Official Master's Degree 1st four-month period
 First Obligatory 6
Language
Spanish
Teaching method Face-to-face
Prerequisites
Department Ciencias da Saúde
Matemáticas
Coordinador
Estevez Perez, Maria Graciela
 E-mail
graciela.estevez.perez@udc.es
Lecturers
Estevez Perez, Maria Graciela
Pértega Díaz, Sonia
 E-mail
graciela.estevez.perez@udc.es
s.pertega@udc.es
Web http://http://www.imedir.udc.es/mais/
General description Esta materia, dividida en dous grandes bloques, completa a formación básica probabilística e estatística introducida pola materia "Estatística aplicada a Ciencias da Saúde". O primeiro bloque temático permite afondar na inferencia de dous e máis mostras tanto dende un punto de vista paramétrico como non paramétrico.
Pola súa banda, o segundo bloque temático, introduce ao alumnado nos métodos de xustificación do tamaño muestral para o deseño de estudos clínico-epidemiolóxicos e nos estudos de validación de probas diagnósticas.

Study programme competencies
Code Study programme competences
A1 Capacidade para elixir e aplicar as metodoloxías de investigación mais adecuadas á investigación proposta.
A2 Capacidade para o deseño experimental e o completo desenvolvemento de proxectos de investigación no ámbito sanitario, desde a formulación da hipótese de investigación ata a comunicación dos resultados.
A3 Adquirir un sentido ético da investigación sanitaria.
A4 Obter un substrato teórico suficiente para comprender o entorno clínico de aplicación das técnicas de investigación.
B1 Capacidade para aplicar o método científico na planificación e o desenvolvemento da investigación sanitaria.
B2 Fluidez e propiedade na comunicación científica oral e escrita.
B3 Compromiso pola calidade do desenvolvemento da actividade investigadora.
B4 Capacidade de análise e de síntese.
B5 Habilidade para manexar distintas fontes de información.
B6 Capacidade para traballar de forma colaborativa en equipos multi e interdisciplinar.
C1 Expresarse correctamente, tanto de forma oral coma escrita, nas linguas oficiais da comunidade autónoma.
C2 Dominar a expresión e a comprensión de forma oral e escrita dun idioma estranxeiro.
C3 Utilizar as ferramentas básicas das tecnoloxías da información e as comunicacións (TIC) necesarias para o exercicio da súa profesión e para a aprendizaxe ao longo da súa vida.
C5 Entender a importancia da cultura emprendedora e coñecer os medios ao alcance das persoas emprendedoras.
C6 Valorar criticamente o coñecemento, a tecnoloxía e a información dispoñible para resolver os problemas cos que deben enfrontarse.
C7 Asumir como profesional e cidadán a importancia da aprendizaxe ao longo da vida.
C8 Valorar a importancia que ten a investigación, a innovación e o desenvolvemento tecnolóxico no avance socioeconómico e cultural da sociedade.

Learning aims
Learning outcomes Study programme competences
To analyze data using descriptive techniques and to make inferences about populations from partial information obtained by random sampling AR1
AR2
AR3
AR4
 BC1
BC2
BC3
BC4
BC5
BC6
 CC1
CC2
CC3
CC5
CC6
CC7
CC8
To use the auxiliary tools and interpret the obtained results AR1
AR2
AR3
AR4
 BC1
BC2
BC3
BC4
BC5
BC6
 CC1
CC2
CC3
CC5
CC6
CC7
CC8

Contents
Topic Sub-topic
Normality test 1. Graphic methods
2. Analytical methods
Two-Sample Inference 1. Two-Sample Inference for related variables.
2. Two-Sample Inference for independent variables
Introduction to the Analysis of Variance 1. ANOVA models
2. Nonparametric alternatives to ANOVA
Sample size determination 1. Determination of sample size for estimating parameters.
2. Determination of sample size for testing hypotheses.
3. Sample size calculations for case-control studies.
4. Sample size calculations in studies monitoring.
5. Determination of sample size for estimating correlation coefficient.
Validation of diagnostic test 1. Validity and reliability of diagnostic tests: sensitivity, specificity, predictive values, likelihood ratios
2. The clinical application of Bayes' theorem
3. Receiver-operating characteristics (ROC) curves and área under the curve

Planning
Methodologies / tests Competencies Ordinary class hours Student’s personal work hours Total hours
Document analysis A1 A2 A3 A4 B1 B4 B5 C2 C5 C6 C7 C8 20 50 70
Online forum A1 A2 A4 B1 B6 C1 C3 C6 12 30 42
Seminar A1 A2 A3 A4 B1 B2 B3 C1 C5 C6 C7 C8 4 10 14
Case study A1 A2 B1 B2 B4 B5 B6 C1 C3 C6 4 12 16
Supervised projects A1 A2 A3 A4 B1 B2 B3 B4 B5 B6 C1 C3 C6 C8 2 4 6
 
Personalized attention 2 0 2
 
(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies
Methodologies Description
Document analysis Supervised study using material multimedia (recorded classes, videos, slides, pdf documents)
Online forum Online tools for monitoring and tutoring (forums, discussions)
Seminar Seminars (work in group method to exchange information, make documents and discuss theories)
Case study Continuous evaluation (written tests, problems to correct, participation in virtual class)
Supervised projects Final evaluation (final work that reflects the control of the subject and/or final exam)

Personalized attention
Methodologies
Online forum
Seminar
Case study
Supervised projects
Description
The employed methodologies include personalized attention


Assessment
Methodologies Competencies Description Qualification
Case study A1 A2 B1 B2 B4 B5 B6 C1 C3 C6 Written tests, problems to correct, participation in virtual class 50
Supervised projects A1 A2 A3 A4 B1 B2 B3 B4 B5 B6 C1 C3 C6 C8 Final work that reflects the control of the subject and/or final exam 50
 
Assessment comments

The assessment criterion of Block I (three first subjects) will be in the following way: 50% of the qualification will be obtained of questionnaires and/or problems to correct  and the 50% remaining of a work consistent in the resolution of a practical case. This work can be carried out in an individual way or in groups of two or three members. The maximum total score of this block will be 5 points.

Evaluation of Block II (last two subjects) will be made by resolution of a test consisting of 5 case studies related to each of the two themes of this block: sample size justification and diagnostic tests studies. Each of estes cases will be evaluated with 1 point, where the proposal for a correct answer, the argument of the resolution of each case and the use of the web resources provided will be taken into account. The maximum total score of this block will therefore be 5 points.

To obtain a NR (No Grade Reported), the student must not participate in any learning activities

To help achieve a sustainable immediate environment and meet the objective 9 of "I Plan de Sostenibilidad Medio-Ambiental Green Campus FCS", the documentary works will be requested in virtual format and computer support. If some of them were carried out on paper:  

a.- Don't use plastic.

b.- The impressions will be made double face.

c.- Recycled paper will be used.

d.- Printing drafts should be avoided, especially in color.

Sources of information
Basic

Basics references:

  • Documents made by the teacher that will be accessible through the virtual platform

Other References:

  • Bioestadística: métodos y aplicaciones. Francisca Ríus Díaz, Francisco Javier Barón Lopez, Elisa Sánchez Font y Luis Parras Guijosa. Universidad de Málaga. http://www.bioestadistica.uma.es/libro/
Complementary

Other References:

  • Bioestadística: métodos y aplicaciones. Francisca Ríus Díaz, Francisco Javier Barón Lopez, Elisa Sánchez Font y Luis Parras Guijosa. Universidad de Málaga. http://www.bioestadistica.uma.es/libro/

Recommendations
Subjects that it is recommended to have taken before

Subjects that are recommended to be taken simultaneously

Subjects that continue the syllabus

Other comments


(*)The teaching guide is the document in which the URV publishes the information about all its courses. It is a public document and cannot be modified. Only in exceptional cases can it be revised by the competent agent or duly revised so that it is in line with current legislation.