Defining medical data

Means of medical data collection Methods of medical data collection Research instruments

Data analysis plan

 Medical data = variables A variable = function (it can take different values for

each sample or target population element)

Establishing variable type

 Variables are classified in two groups:

Quantitative variables (which can be measured)

Qualitative variables (which cant be measured)

Qualitative variables are:

Nominal variables = groups of elements which cant be

organized (hair color)

Ordered nominal variables = the conclusions can be grouped

e.g.: the treatment efficiency: very good/good/bad

Binary variables = there are only two possibilities: ill/healthy,

YES/NO

VARIABLES TYPES
Quantitative variables are:
Continuous variables = measurable variables which can take

an infinite number of values, usually placed in an interval

e.g.: values of cholesterol, values of blood pressure

Discontinuous variables = variables which can only take

integer values e.g.: APGAR score

VARIABLES TYPES
Survival variables
It corresponds to the time passed between a subject

inclusion in a study and a predefine element turn up

(death, metastasis, complication)

MEAN OF DATA COLLECTION

Regarding studied elements:
Exhaustive collection. All population subjects that we desire

to study. Hard to accomplish due to high costs or study

population alteration.
By sampling. Is the method used in medical studies.

MEAN OF DATA COLLECTION

Regarding the length of collection:
Transverse. A group is studied in a precise moment in time. Longitudinal (extended in time):
Retrospective based on medical registers Prospective data collected on pre-established time intervals.

METHODS OF MEDICAL DATA COLLECTION

The interview Individual interview Group interview

It involves similar methodological steps with the observation

METHODS OF MEDICAL DATA COLLECTION

The questionnaire Introduction Body Questions statement Questionnaire graphics

METHODS OF MEDICAL DATA COLLECTION

Existing records Hospital observation papers Consultation records Laboratory records Operating room records

Research instruments
Choosing the research instrument depends on: Study objective The researched disease The population to study

Research instruments

Library study The computer Experimental determinations Statistics Human mind Language and communication facilities

Research instruments
Library study Library catalogs Indexes and abstracts Librarian references The search through library book shelves

Research instruments
The computer The Internet and World Wide Web (WWW) Medical data search and selection engines Electronic mail (e-mail)

Research instruments
Experimental determinations Qualitative and quantitative phenomenon quatification Variables standardization (nominals ordinals, etc.) Method validation Method reproducibility

Research instruments
Statistics o Descriptive statistics o Inferential statistics Statistical tests statistical significance

Research instruments
Human mind

o Statistically significant

vs. o Scientific significant

Research instruments
Language and communication o Stating facts Oral In writing o Verbal nuance

Data analysis plan

Defining the purpose Defining the objectives Defining the working hypotheses Sampling Ensuring data quality Testing the hypotheses

Data analysis plan

Defining the purpose: To describe a health issue (to evaluate the

pulmonary tuberculosis in Mures county) To evaluate a diagnostic procedure (to establish the quality of ultrasonography in diagnosing gallstones)

Data analysis plan

Defining the purpose: To evaluate a therapeutic approach (to

demonstrate the efficiency of laparoscopic cholecystectomy for gallstones) Risk and/or prognosis factor research (to demonstrate the role of heptavalent chromium in the etiology of chronic obstructive pulmonary disease)

Data analysis plan

Defining the study objectives: To describe a health issue Main objective (to calculate the prevalence of

pulmonary TB in target population) Secondary objectives (setting the target population, choosing the diagnose method, etc.)

Data analysis plan

Defining the study objectives: To evaluate a diagnostic procedure Main objective (to calculate the performance

parameters of ultrasonography, sensibility, specificity) Secondary objectives (setting the target population, defining the golden standard, etc.)

Data analysis plan

Defining the study objectives: To evaluate a therapeutic approach Main objective (to compare the efficiency of

laparoscopic cholecystectomy to the classical one) Secondary objectives (setting the target population, setting the comparison criteria, etc.)

Data analysis plan

Defining the study objectives: The research of risk and/or prognosis factors Main objective (to calculate the role of

chromium in the etiology of pulmonary disease) Secondary objectives (setting the target population, ensuring the compatibility between the study groups, etc.)

Data analysis plan

Defining the working hypotheses: To describe a health issue The prevalence of pulmonary TB in Mures

county is a public health problem To evaluate a diagnostic procedure Ultrasonography in gallstones diagnose is more sensitive and more specific than the clinical criterias.

Data analysis plan

Defining the working hypotheses: To evaluate a therapeutic approach Laparoscopic cholecystectomy is easier

supported by the patient than the classical one The research of risk and/or prognosis factors Chromium is a risk factor for pulmonary disease

Data analysis plan

Sampling To describe a health issue Representative sample (qualitative and

quantitative, transverse) To evaluate a diagnostic procedure Unrepresentative sample (qualitative and quantitative, transverse)

Data analysis plan

Sampling:

To evaluate a therapeutic approach

Case-control data collection (retrospective,

longitudinal) The research of risk and/or prognosis factors Case-control data collection (retrospective, longitudinal) Exposed-unexposed data collection (prospective, longitudinal)

Data analysis plan

Ensuring data quality:

Initial training of the data collectors

(investigators) Periodic verification of the data collection methods Parallel data collection (if the data collection instrument allows it) Investigators retraining

Data analysis plan

Ensuring data quality:

Database development
Operator training Data input into two parallel databases for

comparison reasons The development of validation programs for incorrect, extreme or missing values (aberrant, outliers, missing data)

Data analysis plan

Hypotheses testing

Setting the data to compare

Setting the variable type which express medical

data to compare The correct choosing of statistical tests The elaboration of dummy tables for each hypothesis to test

Choosing statistical tests

Data type Purpose Gaussian distribution Non-Gaussian distribution Binomial

Single group description

Mean, standard deviation

Median

Proportion

Comparing a single group to a hypothetical value Comparing two unpaired samples

One sample Student test

Wilcoxon test

Chi square

Student test for unpaired data

Mann Whitney test

Fisher test (chi square for large samples)

Comparing two paired samples Comparing two or more samples

Student test for paired data

Wilcoxon test

McNemar test

ANOVA

Kruskal Wallis test

Cox regression