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Unit of observation versus unit of analysis

Article  in  BMJ Clinical Research · June 2014

DOI: 10.1136/bmj.g3840 · Source: PubMed

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BMJ 2014;348:g3840 doi: 10.1136/bmj.g3840 (Published 13 June 2014)
Endgames
STATISTICAL QUESTION
Unit of observation versus unit of analysis
Philip Sedgwick reader in medical statistics and medical education
Institute of Medical and Biomedical Education, St George’s, University of London, London, UK
Researchers investigated the effects of a school based
educational programme aimed at reducing the consumption of
carbonated drinks to prevent weight gain in children aged 7-11
years. A cluster randomised controlled trial study design was
used. The programme, which was delivered over one school
year, focused on promoting a healthy diet. The control group
received no intervention. Six primary schools in southwest
England were recruited and 29 classes were involved in the trial.
Classes were randomised to treatment, with 15 classes allocated
to the educational programme (325 children) and 14 to the
control treatment (319 children).1
The outcome measures included consumption of carbonated
drinks. Each child recorded the number of glasses (average size
250 mL) that he or she drank over a three day period at baseline
and at the end of the trial, and the change from baseline was
obtained. For each class (the cluster), the average change in
consumption of carbonated drinks across all children was
derived. The treatment groups were compared with regard to
the average change within clusters. Over one school year, the
consumption of carbonated drinks decreased by a mean of 0.6
glasses per cluster in the intervention group but increased by
0.2 glasses per cluster in the control group (mean difference
0.7, 95% confidence interval 0.1 to 1.3).
Which of the following statements, if any, are true?
a) The unit of observation was the class
b) The unit of analysis was the class
c) It can be assumed that the measurements for children
within a class (cluster) were independent of each other
Answers
Statement b is true, whereas statements a and c are false.
The unit of observation and unit of analysis are often confused.
The unit of observation, sometimes referred to as the unit of
measurement, is defined statistically as the “who” or “what”
for which data are measured or collected. The unit of analysis
is defined statistically as the “who” or “what” for which
information is analysed and conclusions are made.
The above trial used a cluster randomised controlled trial study
design, described in a previous question.2 Participants were
p.sedgwick@sgul.ac.uk
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ENDGAMES
recruited through cluster sampling.3 Six primary schools in
southwest England were recruited and 29 classes were involved
in the trial. The class was the cluster, and all children in each
selected cluster were invited to participate. The clusters rather
than the children were randomised to treatment using cluster
allocation.4 The class was therefore the unit of randomisation.
The unit of randomisation is defined statistically as the “who”
or “what” that is randomised to treatment in a trial.5 All the
children in a cluster received the treatment—a school based
educational programme or control (no intervention)—that their
cluster had been allocated to. The cluster was therefore the unit
of intervention, defined statistically as the “who” or “what” for
which the intervention was delivered.
In the example above, data were recorded for each child. The
consumption of carbonated drinks over a three day period at
baseline and at the end of the trial was measured. The change
in consumption of carbonated drinks from baseline was obtained
for each child. Therefore, the unit of observation was the child
(a is false). For each cluster, the mean change in consumption
of carbonated drinks across the children in the class was derived.
The treatment groups were compared with regard to the average
change across clusters (15 for the intervention and 14 for the
control). Therefore, the unit of analysis was the cluster (b is
true).
In the example above, the unit of analysis was the cluster.
Because each cluster provided only one measurement, the data
were considered independent, so standard statistical tests could
be used to compare treatment groups. Alternatively, the child
could have been the unit of observation. The treatment groups
would then have been compared regarding the change in
consumption of carbonated drinks averaged across the trial
participants. However, if the child had been the unit of analysis,
the probability of spurious significant findings and misleading
conclusions would have increased. This is because a cluster
randomised controlled trial design was used—children within
a class would be more likely to respond in a similar manner to
treatment and could not be assumed to be acting independently
(c is false). Children within the same cluster would be more
likely to experience similar outcomes than would those in other
clusters, irrespective of treatment allocation. This lack of
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 BMJ 2014;348:g3840 doi: 10.1136/bmj.g3840 (Published 13 June 2014)
independence of measurements within clusters is usually
assessed with the intraclass correlation coefficient (ICC),
described in a previous question.6 If the child had been the unit
of analysis then comparison of treatment groups would have
needed to account for the lack of independence between children
within a class (the cluster).
Consideration of the unit of observation and unit of analysis is
important in other study designs, such as ecological studies, and
not just clinical trials. Ecological studies were described in a
previous question,7 in which the example used investigated the
association between child wellbeing and economic status in rich
developed societies.8 Twenty three of the richest 50 countries
in the world were included. Data were collected for the child
and aggregated across the country. Therefore, the unit of
observation was the child, whereas the unit of analysis was the
country. Because the unit of observation and unit of analysis
are different in ecological studies, results from such studies are
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ENDGAMES
prone to the ecological fallacy. The ecological fallacy is a term
used when collected data are analysed at a group level and the
results are assumed to apply to associations at the individual
level.9
Competing interests: None declared.
1 James J, Thomas P, Cavan D, Kerr D. Preventing childhood obesity by reducing
consumption of carbonated drinks: cluster randomised controlled trial. BMJ 2004;328:1237.
2 Sedgwick P. Cluster randomised controlled trials. BMJ 2012;345:e4654.
3
4
Sedgwick P. Cluster sampling. BMJ 2014a;348:g1215.
Sedgwick P. Treatment allocation in trials: cluster randomisation. BMJ 2014b;348:g2820.
5 Sedgwick P. Clinical trials: units of randomisation. BMJ 2014;348:g3297.
6 Sedgwick P. Intraclass correlation coefficient. BMJ 2013;346:f1816.
7 Sedgwick P. Ecological studies: advantages and disadvantages. BMJ 2014;348:g2979.
8 Pickett KE, Wilkinson RG. Child wellbeing and income inequality in rich societies: ecological
cross sectional study. BMJ 2007;335:1080.
9 Sedgwick P. The ecological fallacy. BMJ 2011;343:d4670.
Cite this as: BMJ 2014;348:g3840
© BMJ Publishing Group Ltd 2014
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