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Pearl Kendrick: Using Careful Controls

During the 1930s, Pearl Kendrick at the Michigan Department of Health developed a
whooping cough (pertussis) vaccine that she hoped would be more effective than
previous vaccines. An important part of showing the effectiveness of the vaccine
involved a control group of children who did not receive the vaccine. This was something
of an innovation at the time, but Kendrick knew that having a control group would add
weight to her findings if the vaccine proved to be effective. The rate of pertussis disease
in the control group would allow Kendrick to easily demonstrate whether or not her
vaccine could reduce the rate of disease in the experimental group.

Batuk rejan atau pertusis adalah infeksi bakteri pada paru-paru dan saluran
pernapasan yang mudah sekali menular. Batuk rejan sempat dianggap penyakit
anak-anak saat vaksin pertusis belum ditemukan. Sebenarnya batuk rejan juga
dapat diderita orang dewasa, namun penyakit ini dapat mengancam nyawa bila
terjadi pada lansia dan anak-anak, khususnya bayi yang belum cukup umur untuk
mendapat vaksin pertusis.
Penyakit ini punya ciri rentetan batuk keras terus menerus yang diawali tarikan
napas panjang lewat mulut (whoop). Seseorang bisa menderita batuk rejan hingga
tiga bulan lamanya, sehingga penyakit ini juga biasa disebut batuk seratus hari.

Kendrick assigned children to her pertussis experimental group if they came to a clinic
seeking pertussis vaccination. For the control group, she found children at random from
a list kept by a city health department of unimmunized children. One fault that we would
see today in Kendricks experiment design was the lack of randomization in the
assignment of children to either the experimental group or the control group.
Randomization is a method of using chance alone to assign subjects to a control or
experimental group. Researchers use randomization because it helps to ensure that
differences between the two groups will not influence the outcome of the experiment. If
Kendrick had randomized assignments, she would have minimized differences between
the vaccinated group and the group she merely observed.

Randomisasi merupakan syarat penelitian eksperimental

Randomisasi bertujuan agar terjadi komparabilitas (validitas interna) antara
kelompok studi dan kontrol sama
Randomisasi tidak sama dengan pengambilan sampel secara random
Acak Sederhana (Simple Randomization)
Randomisasi dengan Blok (Bloked Randomization)
Acak Stratifikasi (Stratified Randomization)

Randomisasi merupakan langkah peting dalam penelitian yang tidak dilakukan

secara sensus. Dengan randomisasi yang baik maka akan dapat diperoleh
sampel yang representatif yang mewakili populasi. Dengan demikian simpulan
yang diperoleh atas dasar hasil analisis statistika dapat berlaku dalam tingkat
populasi. Prinsip tersebut berlaku bila penelitian secara sampling tersebut
merupakan penelitian noneksperimen. Teknik pengambilan sampel merupakan
suatu prosedur yang harus ditempuh oleh peneliti, agar sebagian individu atau
item anggota dari populasi yang diteliti, benar-benar representatif atau dapat
mewakili populasinya. Jika sampel yang diambil tidak representatif maka
kesimpulan yang diperoleh pada tingkat sampel tidak berlaku pada tingkat
populasinya. Jika demikian halnya maka bukan lagi merupakan penelitian
sampling, akan tetapi hanya merupakan penelitian kasus

In spite of this shortcoming, Kendricks trial helped establish norms and expectations for
future vaccine trials, and it clearly showed the efficacy of her vaccine.

Jonas Salk: A Double-Blind Randomized Trial

The 1954 field trial of Jonas Salks inactivated poliovirus vaccine (IPV) was another
important milestone in the use of the scientific method to test a vaccine. This trial
enrolled a huge number of subjects1.3 million children in allin what is the largest
medical field trial ever conducted.
The Salk trial was a carefully designed double-blind randomized experiment. This
meant, first, that children were randomly assigned to either the control or the
experimental group. Double-blind meant that no onenot the child, the parent, the
person who gave the injection, nor the person who assessed the child's healthknew
whether an individual child received the polio vaccine or a placebo injection. (A placebo
is an inactive substance. In this case, the placebo was a saltwater solution.) The

information about whether the child received the vaccine or the placebo was encoded in
numbers on vials from which the injected material was taken, and it was linked to the
childs record. Only after the observation period was over and the result recordeddid
the child develop polio during the observation period or not?was the childs
experimental or control status revealed.
Authorities did not achieve the double-blind, randomized standard across the entire polio
vaccine trial. In some communities, officials objected to the use of a placebo injection, so
the children in the control group were merely observed for signs of polio. These groups
were known as observed controls. Some designers of the study worried that differences
between the observed control and experimental groups might influence the outcome. For
instance, the observed control group included children whose parents would not consent
to their receiving the vaccine. Were there important differences, such as income or
housing or parental age, between children whose parents would not consent and those
who would? And might those differences affect whether children had already been
exposed to and become immune to polio?
The Salk vaccine trial successfully showed that the vaccine helped prevent paralytic
polio, and licensure of the vaccine quickly followed. The disease that once paralyzed
thousands of children has now been eliminated in the Western Hemisphere.

Why trials are randomised

Researchers randomise trials because they need to be sure that the results are correct and there
is no bias that could distort the results.
Of course, researchers are unlikely to be deliberately biased. But it is possible to be biased
without realising it. For example, if a new treatment has quite bad side effects the doctors
running the trial might subconsciously avoid putting patients who are more ill into the group
having the new treatment. So as the trial went on, the control group would have more and more
of the ill patients in it. The people in the new treatment group would then do better than the
control group. So, when the trial results come out, the new treatment would look as if it works
better than the standard treatment. But really it doesn't.

Details of all the people in the trial are put into the computer to help with randomisation. The
details include age, gender and stage of the cancer. This makes sure that the groups are
reasonably equal. For example, if doctors didn't take cancer stage into account for some trials,
they could end up with one group containing people with more advanced cancers and this could
also bias the trial results.

Blind trials
A blind trial is a trial where the people taking part don't know which treatment they are getting.
They could be getting the new treatment. Or they could be getting standard treatment or a
placebo, depending on the design of the trial. All patients receive identical injections or tablets,
so they can't tell which treatment they are having.

Double blind trials

A double blind trial is a trial where neither the researchers nor the patients know what they are
getting. The computer gives each patient a code number. And the code numbers are then
allocated to the treatment groups. Your treatment arrives with your code number on it. Neither
you nor your doctor knows whether it is the new treatment or not.
The list of patients and their code numbers is kept secret until the end of the trial. In an
emergency the researchers could find out which trial group a patient was in, but generally no one
knows until the trial had finished.

Sir Ronald Aylmer Fisher

The Editors of Encyclopdia Britannica

Sir Ronald Aylmer Fisher, byname R.A. Fisher (born February 17,
1890, London, Englanddied July 29, 1962, Adelaide, Australia) British
statistician and geneticist who pioneered the application of statistical
procedures to the design of scientific experiments.

In 1909 Fisher was awarded a scholarship to study mathematics at

the University of Cambridge, from which he graduated in 1912 with a B.A.
in astronomy. He remained at Cambridge for another year to continue
course work in astronomy and physics and to study the theory of errors.
(The connection between astronomy and statistics dates back to Carl
Friedrich Gauss, who formulated the law of observational error and
the normal distribution based on his analysis of astronomical observations.)

Fisher taught high school mathematics and physics from 1914 until 1919
while continuing his research in statistics and genetics. Fisher had
evidenced a keen interest in evolutionary theory during his student days
he was a founder of the Cambridge University Eugenics Societyand he
combined his training in statistics with his avocation for genetics. In
particular, he published an important paper in 1918 in which he used
powerful statistical tools to reconcile what had been apparent

inconsistencies between Charles Darwins ideas of natural selection and

the recently rediscovered experiments of the Austrian botanist Gregor

In 1919 Fisher became the statistician for the Rothamsted Experimental

Station near Harpenden, Hertfordshire, and did statistical work associated
with the plant-breeding experiments conducted there. His Statistical
Methods for Research Workers (1925) remained in print for more than 50
years. His breeding experiments led to theories about gene dominance and
fitness, published in The Genetical Theory of Natural Selection (1930). In
1933 Fisher became Galton Professor of Eugenics at University College,
London. From 1943 to 1957 he was Balfour Professor of Genetics at
Cambridge. He investigated the linkage of genes for different traits and
developed methods of multivariate analysis to deal with such questions.

At Rothamsted Fisher designed plant-breeding experiments that

provided greater information with less investments of time, effort, and
money. One major problem he encountered was
avoiding biasedselection of experimental materials, which results in
inaccurate or misleading experimental data. To avoid such bias,
Fisher introduced the principle of randomization. This principle states
that before an effect in an experiment can be ascribed to a given
cause or treatment independently of other causes or treatments, the
experiment must be repeated on a number of control units of the
material and that all units of material used in the experiments must be
randomly selected samples from the whole population they are
intended to represent. In this way, random selection is used to
diminish the effects of variability in experimental materials.

An even more important achievement was Fishers origination of the

concept of analysis of variance, or ANOVA. This statistical procedure
enabled experiments to answer several questions at once. Fishers
principal idea was to arrange an experiment as a set of partitioned
subexperiments that differ from each other in one or more of the

factors or treatments applied in them. By permitting differences in

their outcome to be attributed to the different factors or combinations
of factors by means of statistical analysis, these
subexperiments constituted a notable advance over the prevailing
procedure of varying only one factor at a time in an experiment. It was
later found that the problems of bias and multivariate analysis that
Fisher had solved in his plant-breeding research are encountered in
many other scientific fields as well.

Fisher summed up his statistical work in Statistical Methods and Scientific

Inference (1956). He was knighted in 1952 and spent the last years of his
life conducting research in Australia.