DEBRE BIRHAN UNIVERSITY

COLLEGE OF NATURAL AND COMPUTITIONAL

SCIENCE
DEPARTMENT OF STATISTICS BIO STATISTICS
CLINICAL REPORT WRITING PRESENTATION
PREPARED BY: BIRUK DEGEFE
ID NO: PGR 159 /09
: DEMISEW GEBEYEHU
ID NO : PGR 162/09
SUBMITTED TO: A.R.Muralidharan (Phd)

1. Aim of the study

For the first study
To gather preliminary data about the safety and
efficacy of psilocybin-assisted psychotherapy in
people diagnosed with anxiety arising from a
diagnosis of Stage IV melanoma.
For the second study
To determine the effect of the
early
administration of tranexamic acid on clinical
outcomes (mortality, hysterectomy and other
morbidities) in women with clinically
diagnosed postnatal haemorrhage.

1.1 Specific objectives

For the first study
To assess possible relationships between
measures of the psilocybin experience and
anxiety and spiritual beliefs.
For the second study
To evaluate the effect of TXA on markers of
coagulation in a sample of WOMAN trial
participants.

2. Literatures
Melanoma is a cancer arising from pigmentproducing cells, or melanocytes.
These cells are chiefly located in the skin, but
they can also be found in other parts, including
eyes and ears .
While melanoma accounts for 4% of all skin
cancers, it is associated with 77% of mortality
due to skin cancer.
Development of melanoma is due to multiple
factors, including sun exposure and blistering
sunburn, fair skin complexion, and increased
numbers of moles.

For the second study

Normal haemostasis is the controlled
activation of clot formation and clot lysis
that
stops
haemorrhage
without
inappropriate thrombosis formation.
haemostasis is achieved by two systems
working together, the coagulation system,
i.e. the system that produces blood clots
and the fibrinolytic system which dissolves
clots.
The fibrinolytic system acts as a balance
to the coagulation system, preventing
excess clotting by breaking down fibrin.

3 . Previous examples
The term cancer is commonly used to cover a
wide range of diseases which all share a common
feature, namely that cells in affected organs or
tissues of the body (e.g. breast, lung, skin or bone
marrow) continue to grow indefinitely, without
reference to the needs of the body.
Many cancers have the capacity to spread to other
parts of the body and to kill the patient. With more
than 3 million new cases and 1.7 million deaths
each year (Ferlay et al., 2007), cancer currently
represents the second most important cause of
death and morbidity in Europe.

 The annual rates of newly diagnosed cancer

patients (incidence rates) and deaths from
cancer (mortality rates) are changing.
Some cancers (e.g. Stomach cancer) are
becoming less common, but others are
increasing, such as malignant melanoma - the
most dangerous form of skin cancer.
some cancers show different trends between
men and women, or young and old, or poor and
rich. For instance, lung cancer rates are falling
in many countries among men (particularly the
more wealthy groups) but increasing among
women, particularly the young.

 Trends in the incidence and mortality rates are

also influenced by successes in health
promotion (e.g. tobacco control), efficient
screening (e.g. breast) and better treatment.
These have been reflected in lower incidence,
reduced mortality, higher survival, improved
life expectancy and a better quality of life for
cancer survivors.
For the second study There is no standard
definition of PPH. PPH is typically described as
bleeding in excess mL of blood after birth.

 PPH is often further classified as primary (in

the first 24 hours postpartum) or secondary
(delayed, after 24 hours postpartum).Clinically,
any amount of blood loss that results in signs
and symptoms of hypovolemic shock or
hemodynamic instability should be considered
PPH.
This amount may be lower than 500 mL in a
woman with anemia or volume contraction (due
to dehydration or gestational hypertension with
proteinuria).

4 . Methodology
WOMAN trial and will include 200 of its
participants.
The WOMAN trial is a large, pragmatic,
randomized, double blind, placebo controlled
trial of adult women, who have clinically
diagnosed postpartum haemorrhage and who
fulfill the eligibility criteria.
we will adjust for baseline measurement and
assuming
that
the
correlation
between
baseline
and
followup
is
0.4 (positive
correlation), a study with 180 patients would
have about 90% power (two sided alpha=5%)
to detect a reduction of 30% in the mean
value in the tranexamic group.

Eligibility Criteria
All legally adult women with clinically
diagnosed postpartum haemorrhage.
Where
the
responsible
clinician
is
substantially
uncertain
as
to
the
appropriateness of antifibrinolytic agents in
a particular woman with PPH.
Randomization : will be balanced by center,
with an allocation sequence based on a block
size of eight.
Analysis :Both intention to treat and perprotocol
analysis will be done.

 Data Collection : Data will be collected as per

the WOMAN trial (i.e. relevant entry data to
assess eligibility and randomization details and
outcome data at death in hospital or 42 days
after randomization, whichever occurs first).
Demographic
and
other
baseline
characteristics will be tabulated. Descriptive
statistics for continuous variables will include
the mean, standard deviation, median, range,
and the number of observations.
For the second study
This study will use a randomized, active-placebo
controlled, double-blind design.

 Subjects who meet the study admission criteria

will be enrolled into the study and will be
assigned a 4-digit subject number. The first
two digits identify the study site. The next two
digits identify the subject within the site and
will be assigned sequentially, with 01
corresponding to the first subject enrolled, e.g.
the first enrolled subject will be 0101, second
0102, etc.
Randomized blinded Study phase
Upon enrollment into the study, participants
will be assigned to one of two conditions, active
placebo (4 mg psilocybin) or full experimental
intervention (25 mg psilocybin).

Data Analysis:
The primary analyses for this study will be a
repeated measures analysis of variance
(ANOVA) withcondition (active placebo versus
experimental dose)
The investigators will perform two repeated
measures ANOVAs comparing average pain
levels at baseline versus for the weeks
immediately after the first and after the second
experimental sessions, with p.

5 . Report writing
a) General aspect: Both research focus on
current issues or problems which touch
everybody even if the degree of severity of the
problem is differ. Even the problem of cancer
is the big issue in developed country and
maternal mortality is also in developing
country.
b) Specific aspect:
Ethical issue: in our sight of view both studies
tried to fulfill the ethical issues as we can see
for instance the first study pregnant women
will be excluded from participation in the
proposed study.

 Consent : both study applies informed consent

in the binging of their study
Adverse events: Safety will be assessed
through recording adverse events and serious
adverse events first study also clearly. Any
untoward medical occurrence affecting a
trial participant up to day 42 will be
reported in line with the WOMAN trial
protocol.
Unbinding : In general there should be no
need to un blind the allocated treatment for
women trial and also the first study is double
blinded design.

c) Critical writing
One of the critical writing issues of clinical report
is clearly identifying the study design before
beginning the study.
From this angle the above two studies that we are
talking about both are clearly state their study
design as well.
In my opinion the randomization process for
women trial is better than to that of the first study
The analysis part for woman trait study is
presented by simple descriptive statistics and
clearly identified in the study but the first study is
used also test statistics and advanced methods
relatively.

 because of their randomization is balanced for

each center and all has a chance to be included
but in the first study there is two group the first 8
peoples is selected randomly but there is also
another peoples included by self-selection.
When we talk about data collection the second
study (woman trial) uses secondary data for the
study .
This by itself needs quality control mechanism
because of using secondary data has drawback to
the quality data to that of experimental in our
understanding and they clearly set how they tried
to control the data quality so we appreciate .

d) Conclusion

So from the above two studies we can

understand whatever the specific result is they
can meet or observe the correlation between
those variables identified as a question in the
beginning of the general and specific aim of
the study .

Reference
1.Psilocybin-assisted
Psychotherapy
in
the
Management of Anxiety Associated With Stage IV
Melanoma.by Sameet Kumar Ph.D.
2.Tranexamic acid
for
the
treatment
of
postpartum haemorrhage: an international
Randomized, double blind placebo controlled trial
by world maternal trial antifibrinolytic trial.
3.Postpartum Hemorrhage by association of
Ontario midwives.
4.Responding to the challenge of cancer in Europe
by Institute of Public Health of the Republic of
Slovenia.
5.Critical appraisal checklist from internet source.

Thank you