Influence of Obesity on Body Mineral

Density in Postmenopausal Asthma

Patients Undergoing Treatment with
Inhaled Corticosteroids
DK CRP 1 HARM
B-8
Background
Osteoporosis is a systemic skeletal disease that
leads to an increased risk of fracture as a result of a
reduction in the amount of normally mineralized
bone and deterioration in the microarchitectural bone
tissue and trabecular elements.
Asthma is a chronic inflammatory disease of the
airways with an estimated 300 million cases
worldwide and is a significant cause of morbidity that
is associated with reduced quality of life.
The relationship between obesity and asthma has
been widely studied and epidemiological evidence
shows that the prevalence of each condition is
increasing worldwide. The purpose of our study was
to determine the effects of inhaled steroids and
obesity, as well as asthma duration and severity, on
osteoporosis in postmenopausal asthma patients.
Critical Appraisal
Are the results of this harm study
valid?
Were there clearly defined
groups of patients, similar in
all important ways other than
exposure to the treatment or
other cause?
Yes, see page 314, 3
rd

paragraph
Were treatments/exposures
and clinical outcomes
measured in the same ways
in both groups (Was the
assessment of outcomes
either objective or blinded to
exposure)?
Yes, see page 314, 7
th

paragraph
Was the follow-up of study
patients sufficiently long (for
the outcome to occur) and
complete?
No, cross sectional study
Are the results of this harm study
valid?
Do the results of the harm study fulfill some of the diagnostic
test for causation?
Is it clear that the exposure
preceded the onset of the
outcome?
No
Is there a doseresponse
gradient?
No, not significant
Is there any positive evidence
from a dechallenge
rechallenge study?
No
Is the association consistent
from study to study?
Yes, see page 314, 1
st

paragraph
Does the association make
biological sense?
No, see page 313
Are the valid results of this harm
study important?
1. What is the magnitude of the association
between the exposure and outcome?
2. What is the precision of the estimate of the
association between the exposure and the
outcome?
2 x 2 Table
Adverse outcome
Totals
Present
(care)
Absent
(control)
Exposed
to the
treatmen
t
Yes 37 9 46
No 52 8 60
Totals 89 17 106
1. RR = 0,93
NNH = 16
2. 95% CI = 0,88 -
0,98
Can this valid and important
evidence about harm be applied to
our patient?
Is our patient so different from
those included in the study that
its results cannot apply?
No
What is our patients risk of
benefit and harm from the
agent?
See page 316, column 2 last
paragraph.
What are our patients
preferences, concerns and
expectations from this
treatment?
Patient recover from
osteoporosis
What alternative treatments are
available?
Salbutamol
Mobile phone use, exposure to
radiofrequency electromagnetic field, and
brain tumour: a casecontrol study
DK CRP 2 HARM
B-8
Background
The rapid increase in mobile phone use has raised public
concern about their safety (Rothman et al, 1996; Violanti
and Marshall, 1996; Repacholi, 1998; Blettner and Berg,
2000; Rothman, 2000).
Since only glial and meningial tissue close to the surface
of the head is exposed to relatively high electromagnetic
fields (EMFs) emitted from mobile phones, brain tumours,
especially glioma and meningioma, have received
particular attention, along with acoustic neurinoma and
salivary gland tumours.
We have investigated whether mobile phone use
increased brain tumour risk in Japan. The study followed
the common, core protocol of the INTERPHONE study,
but for estimating RF exposure level in different areas of
the brain in light of its great variability, we adopted a new
approach using a heterogeneous head model (Japanese
numerical TARO models head) (Nagaoka et al, 2004).
Critical Appraisal
Are the results of this harm study
valid?
Were there clearly defined
groups of patients, similar in all
important ways other than
exposure to the treatment or
other cause?
Yes, see Method 1
st
paragraph
Were treatments/exposures
and clinical outcomes
measured in the same ways in
both groups (Was the
assessment of outcomes either
objective or blinded to
exposure)?
Yes, see Method 3
rd

paragraph;
Not blind
Was the follow-up of study
patients sufficiently long (for
the outcome to occur) and
complete?
No, case control study
Are the results of this harm study
valid?
Do the results of the harm study fulfill some of the diagnostic
test for causation?
Is it clear that the exposure
preceded the onset of the
outcome?
Yes,
Is there a doseresponse
gradient?
Yes, see table 2
Is there any positive evidence
from a dechallenge
rechallenge study?
Cannot tell
Is the association consistent
from study to study?
No, see Discussion 2
nd

paragraph
Does the association make
biological sense?
Yes,
Are the valid results of this harm
study important?
1. What is the magnitude of the association
between the exposure and outcome?
2. What is the precision of the estimate of the
association between the exposure and the
outcome?
2 x 2 Table (Glioma)
Adverse outcome
Totals
Present
(care)
Absent
(control)
Exposed
to the
treatmen
t
Yes 56 106 162
No 27 57 84
Totals 93 163 262
1. OR = 1,12
NNH = 41
2. 95% CI = 1,07 -
1,16
2 x 2 Table (Meningioma)
Adverse outcome
Totals
Present
(care)
Absent
(control)
Exposed
to the
treatmen
t
Yes 55 118 173
No 73 111 184
Totals 128 229 357
1. OR = 0,71
NNH = 12
2. 95% CI = 0,66 -
0,76
2 x 2 Table (Pituitary Adenoma)
Adverse outcome
Totals
Present
(care)
Absent
(control)
Exposed
to the
treatmen
t
Yes 62 105 167
No 39 56 95
Totals 101 161 262
1. OR = 0,85
NNH = 25
2. 95% CI = 0,8 - 0,89
2 x 2 Table (Brain tumor)
Adverse outcome
Totals
Present
(care)
Absent
(control)
Exposed
to the
treatmen
t
Yes 173 329 502
No 139 224 363
Totals 312 553 865
1. OR = 0,85
NNH = 25
2. 95% CI = 0,82 -
0,87
Can this valid and important
evidence about harm be applied to
our patient?
Is our patient so different from
those included in the study that
its results cannot apply?
Cannot tell
What is our patients risk of
benefit and harm from the
agent?
Not significant
What are our patients
preferences, concerns and
expectations from this
treatment?
Using mobile phone is not risk
factor for brain tumor
What alternative treatments are
available?
Nothing
Any questions?
Thank You