HSPH PBL Write-Up

PBL Scenario: Evidence re: SIDS.

The paper Fleming et al (1996) ‘Environment of infants during sleeping and

risk of sudden infant death syndrome’ BMJ; 313: 191-195 (see Appendix 1),
had been published on the same day as a staff meeting in a large obstetric
unit. During the meeting Doctor A who had read the abstract and Dr B who
had read the paper more thoroughly were discussing it. They both agreed that
it had important messages and it couldn't have been a clinical trial, but A
argues it should have been a cohort study because they have fewer biases
than case control studies. B can't understand why p- values were not given
along with the confidence intervals. He is also surprised that using a dummy
(pacifier) during the last sleep should appear to be protective and wonders if
there could actually be a causal relationship, C joins in and said that his friend
in Holland had just been involved in an, as yet unpublished, Dutch study
which appeared to show that dummy use in the last sleep is beneficial. The
professor asked if they were interpreting the multivariate and univariate
results appropriately.

A& B were told to come back next week to advise on what new messages
should be given to potential parents and to justify their advice.
PBL Objectives
1) Describe the advantages and disadvantages of a Cohort Study Vs a
Case-control Study
2) Describe the link between p values and Confidence Intervals (CI)?
3) What are the differences between Multivariate Results and Univariate
Results?

4) Casuality

5) What is the Clinical significance of the results in paper, what advice

would you give to parents?
1) Describe the advantages and disadvantages of a Cohort Study Vs a Case-
control Study
An observational study is non-randomised study, where researchers do not
intervene or have an input in the lives of the participants; they simply observe
the course of events. They identify and record differences between exposed
and non-exposed groups. The two main types of observational study are
Cohort and Case-Control studies. i
A cohort study involves the monitoring of a group of individuals over a long
period of time (Longitudinal Study). It Involves the comparison of individuals
exposed to a certain health issue/factor and those who are unexposed. The
researcher does not introduce the exposure. ii A case-control study involves
the comparison of people who already have a certain health issue, with those
without it. The researcher then looks over histories of the both groups, to
identify factors that may be associated with the development of the health
issue. 1
Cohort studies have many advantages and disadvantages. Advantages
include the fact that there can be the complete inclusion of information on the
participant’s exposure, as well as quality control of data and experiences
thereafter. As cohort studies are longitudinal they allow for a clear temporal
sequence of exposure and disease. The study of multiple outcomes due to a
specific exposure can be identified. Rare exposures can also be identified.
The methodology and results are easy to understand for non-epidemiologists,
and also certain calculations such as absolute risk and relative risk can be
calculated. However on the flipside there are also many disadvantages, they
are not ideal for the study of rare diseases as large numbers of participants
are required. Also they are not particularly useful for when the time period
between an exposure and the manifestation is a very long time period. Due to
the longitudinal nature of cohort studies exposure patterns may change and
make the results irrelevant. Also follow-ups can be problematic and difficult to
sustain. As there is usually quite a large number of subjects, it can be
expensive to conduct, and data quantity may not be brilliant as long interviews
with large numbers of participants is difficult. iii

As with cohort studies there are many advantages and disadvantages of

case-control studies. The advantages include that there can be the study of
rare diseases. Diseases that have a long latency between exposure and
manifestation can be studied. Case-control studies can be conducted over a
relatively short time period, and are relatively inexpensive. They also allow for
the study of a variety of different causes of a disease. There are also many
disadvantages, information on the exposure and past histories are mainly
taken from interviews and thus are likely to be subject to recall bias. Case
control studies by definition are concerned with one disease only; also they
cannot help with identifying information on incidence rates. Also it is difficult to
control the irrelevant variables. The choice of an appropriate control group
can sometimes be problematic. Also the methodology-undertaken can be
difficult to understand for non-epidemiologists and correct interpretation of
results can be difficult.
To conclude we understand that both studies have different advantages and
disadvantages. Different research questions will require different types of
study. In Choosing the right methodology for acquiring data you have to
consider many different factors, such as the time period between exposure
and disease manifestation, funding, rate of disease incidence and ethical
dilemmas.

If we relate back to the scenario we can understand that Doctor A was correct
in saying that Cohort studies have less bias. As mentioned before case-
control studies mainly obtain their data from interviews and thus a high
likelihood of recall bias. However in this particular investigation where the
objective of the study was to “To investigate the role of sleeping arrangements
as risk factors for the sudden infant death syndrome after a national risk
reduction campaign” iv, a case-control design was much more appropriate. A
Cohort study is relatively more expensive to conduct, as a much larger group
is needed and follow up interviews have to be done. Case-control studies
also give the study an advantage in the fact that they allow the study of
multiple risk factors of SIDS. The design used in the paper was a “Two year
population based case-control study. Parental interviews were conducted for
each infant who died and for four controls matched for age and date of
interview”. 4

2) Describe the link between p values and Confidence Intervals (CI)?

A confidence interval is a range of values used to estimate a population
parameter and is associated with a specific confidence level. A parameter is
data that describes a characteristic about a population. v The confidence level
is usually reported as 95%.vi The odds ratio is a statistical measure of the
chance of developing a health issue if exposed to a certain risk factor or
pathogen. Looking at the results from the paper (table 2) the odds ratio of side
sleeping is 2.01.4 Hence we can see the risk of SIDS is doubled by side
sleeping in comparison to other risk factors, therefore with the confidence
level of 95% we can state that there is a 95% chance the true odds ratio will
be between 1.38 and 2.93. A p value refers to the probability that the result
obtained could have occurred by chance, normally is a number derived from
calculations in the study and is given as either less than 0.05 or more than
0.05.vii If the p-value is less than 0.05, the result is significant and it is agreed
that the null hypothesis should be rejected and the alternative hypothesis that
there is a difference is accepted. DON’T KNOW WHAT TO ADD
HERE….dont understand it properly
i
Beth Israel Deaconess Medical Center ([n.d.]).  Research Glossary [online] .  Available from:
http://www.bidmc.org/YourHealth/HealthResearchJournals.aspx?ChunkID=373102 [accessed
20/4/2010].
ii
Green Facts ([n.d.]).  Glossary [online] .  Available from:
http://copublications.greenfacts.org/en/electromagnetic-fields/glossary-electromagnetic-fields.htm
[accessed 20/4/2010].
iii
Geneva Foundation for Medical Education and Research ([n.d.]).  Cohort and Case-Control
Studies [online] .  Available from:
http://www.gfmer.ch/Books/Reproductive_health/Cohort_and_case_control_studies.html [accessed
20/4/2010].
iv
Fleming et al (1996) ‘Environment of infants during sleeping and risk of sudden infant death
syndrome’ BMJ; 313: 191-195
v
Donnelly RA.  The complete idiot's guide to statistics.  Hudson Street, NY: Penguin Group, 2004.
vi
Bandolier.  Glossary of diagnostic terms [online] [n.d.].  Available from:
www.medicine.ox.ac.uk/bandolier/booth/diagnos/glossary.html [accessed 22/4/2010].
vii
Population Health Forum.  Health and Income Equity [online] [n.d.].  Available from:
http://depts.washington.edu/eqhlth/pages/academic_resources/glossary.html [accessed
22/4/2010].