Clinical Nursing and Research

Program of the form:

INTRODUCTION: BIRTH OF EVIDENCE BASED NURSING
what is Evidence Based Nursing (EBN)
texts, guidelines, EBN sites
even Nursing Research needs Statistics
the common origins of Nursing and Health Statistics
medical, biological and political thinking at mid-Nineteenth century

01. ROLE OF MEDICAL STATISTICS IN HEALTHCARE RESEARCH
the health professional as a consumer of research products
the health professional as a co-generator of research
stages of Research: conception, activation, planning, implementation, reporting
the complexity of the problems in the healthcare area
why it is more important to understand concepts than to learn techniques

02. POPULATION, SAMPLE, VARIABILITY
variability as a peculiar characteristic of the biology
why it is necessary to sample
why an adequate sample size is a function of the population heterogeneity
target population as the set of all individuals who meet the inclusion / exclusion criteria, depending on the purpose of the research
connection "sample - population": bias, efficiency, coverage
meaning of accuracy, precision of the estimates, generalisability of the results

03. EVIDENCE OF EFFECTIVENESS: STUDY TYPES
a taxonomy for health studies: observational and experimental studies
reliability of the evidence
the protocol of a study in the healthcare area
from formulating a research question to choosing the proper type of study
natural history of the research in the healthcare area: the case of folic acid

04. DESCRIPTIVE OBSERVATIONAL STUDIES
from the single clinical case to the clinical case series
cross-sectional descriptive studies: prevalent cases, point, period and lifetime prevalence
longitudinal descriptive studies: incident cases, cumulative incidence, incidence density
closed and open populations: the bathtub model

05. ANALYTICAL OBSERVATIONAL STUDIES
risk factors, illness, harmful events
cross-sectional studies (if you observe the disease together with the risk factor)
case-control studies (if you observe the disease before the risk factor)
cohort studies (if you observe the disease after the risk factor)

06. EXPERIMENTAL STUDIES
preclinical and clinical studies
preclinical phases "in vitro", and "in vivo" on laboratory animals
why the preclinical phases are required: the case of thalidomide
experimental descriptive studies: how dr Edward Jenner devised and proved the effectiveness of the smallpox vaccine
what is a clinical trial
why randomisation and blindness are needed
what is "placebo effect"
the role of the different phases of clinical trial, from the phase 0 to phase 4
role and tasks of the Ethics Committee
the origins of ethics of human experimentation: from Nuremberg Code (1947) to Declaration of Helsinki (1964)

07. COLLECTION, MANAGEMENT, AND DATA PROCESSING
pitfalls in designing a questionnaire
pitfalls in designing a CRF (case report form)
how to use spreadsheets to collect data
one rule to be firmly kept in mind: "garbage in, garbage out"

08. VARIABLE AND THEIR REPRESENTATION: TABLES
attributes and variables
qualitative and quantitative variables
Likert scales and Apgar score
how to convey information through tables
frequency distributions
the meaning of simple and cumulative frequencies
how to read a two-entry table

09. VARIABLE AND THEIR REPRESENTATION: GRAPHS
"the figures must be as clear as a picture - they must tell a story as clearly as does a picture of the Crucifixion" (Florence Nightingale)
thesis and literature are plentiful of unnecessary, unintelligible, wrong graphs
when, how and why to trace a pie (or circle) chart
when, how and why to trace a horizontal bar chart
when, how and why to trace a vertical bar chart
when, how and why to trace a histogram
when, how and why to trace a scatterplot

10. CENTRAL TENDENCY AND DISPERSION OF A SERIES OF VALUES
how to sum up in a few numbers the information carried by many numbers
what is the meaning of "index of central tendency" (mode, median, mean)
how to choose which index of central tendency use
what is the meaning of "dispersion index" (range, inter-quartile range, standard deviation)
indices related to standard deviation (sum of squares, mean square, coefficient of variation)
centiles of a distribution
connection between centiles and standard deviation in the Gaussian distribution
be clear! use preferably median and inter-quartile range to describe your data
centiles of a gestational age-dependent distribution: neonatal charts
centiles of an age-dependent distribution: growth charts

11. TO UNDERSTAND AND APPRAISE A SCIENTIFIC PAPER
interpretation of case-control studies (from the occurrence of a harmful event, to the detection of past exposure to a risk factor)
- how to report a case-control study
- the odds as a measure of the frequency of exposure to a risk factor
- the odds-ratio as a measure of the association between harmful event and risk factor interpretation of cohort studies (from the detection of exposure to a risk factor, to the occurrence of a harmful event)
- how to report a cohort study
- the absolute risk as a measure of the occurrence of a harmful event
- the relative risk as a measure of the association between risk factor and harmful event interpretation of randomized controlled trials (appraisal of the effectiveness of an intervention)
- how to report a randomized clinical trial (RCT)
- measures of effectiveness of an intervention, used to report RCTs: absolute risk reduction (ARR), relative risk reduction (RRR), number needed to treat (NNT)
- why we must preferably use NNT as a measure of effectiveness the experimental model in the healthcare area
- what is the meaning of "experimental model"
- how to isolate the effect of the intervention from the placebo effect and the effect of the patient's uniqueness
- role of blindness, simultaneity, sufficient definition of the target population, randomisation, adequate study size in the design of an experimental study
- the confidence interval as expression of the uncertainty of the estimates derived from RCTs aimed at assessing the effectiveness of an intervention
- statistical significance and clinical importance