Event case report forms
(CRFs)
As always you are all doing a fantastic job in completing these forms,
which are an essential component in the success of this
collaboration.
Please keep in mind when filling out the CRFs:
Diabetes is diagnosed with two fasting glucose
values above 7.0 mmol/l (126mg/dl) or, if this data is not
available: by the presence of symptoms combined with either random
values/oral glucose tolerance test above 11.1 mmol/l (200mg/dL) or
information on anti-diabetic treatment.
Please remember that patients who meet the
criteria for this Chronic liver disease (CLD) must have clinical signs
(bleeding from varices, hepatic encephalopathy stage lll-lV or
hepatorenal syndrome) documented in a clinical note and, if available,
a pathology rapport/fibroscan or alternatively information on
transplantation.
Prospective ascertainment of the new endpoints
(End stage renal disease, Chronic liver disease and Non-Aids defining
malignancies) is 01.01.2004- events before this date should not be send
on a CRF to the CC, but should still be recorded in the individual
cohort database and transmitted to the CC during the regular data
mergers.
For ESRD please remember source documentation of 3
months of dialysis or kidney transplantation.
As always, updated CRFs can be found on the CHIP
website: www.cphiv.dk under D:A:D -Study Documents
Update of the
D:A:D Study group
In
order to ensure that the CC had an updated list of participating
physicians and sites, could each cohort please provide the CC
(lrn@cphiv.dk) with the latest update of the list of participating
Principle Investigators (PI) in
the D:A:D study group (deadline 7th
March 2011) so that we can update the study acknowledgments.
Possible
new data collection for 2011, initiated
by the D:A:D Steering Committee (SC)
A survey regarding
the
collection of bilirubin in individual cohorts
has been initiated The SC will discuss whether bilirubin should be
included in future data downloads for D:A:D .
Some sites will
receive
an email in late January with a questionnaire
regarding invasive cervical cancers. These will be reimbursed in the
same way as other D:A:D events. Please reply before 7th March 2011.
Query
process, Spring 2011
During
Spring all cohorts will receive a list of pending events including
- Events not yet
reported
- Events with
outstanding/ incomplete source documentation
- Events with a
date
discrepancy
Please send all
outstanding events to the D:A:D CC before April 15th
2011
Ongoing
scientific projects
-
Liver-related deaths in
patients not HCV/HBV co-infected.
In June
2010 a liver questionnaire was distributed to centers with selected
patients dying from liver related causes. Thanks to everyone that
participated in this project. Due to the very small number of patients
dying from liver-related deaths that were not caused by HBV/HCV
co-infection, the D:A:D SC agreed at the meeting in London (November
2010) that only descriptive analyses would be undertaken on this
endpoint.
Working-groups
Two working groups
have
been established within the D:A:D study: a
Kidney-working group and a Cancer-working group. These groups
include both internal and external experts, and their role is to
discuss scientific and methodological issues concerning these new
fields of interest. A Mortality working group is currently being
established.
Information
and upcoming
deadlines, Merger 12
- A new data
submission
SOP will be available later this Spring
- Data submission
deadline 1st June 2011.
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ACTIVE COHORTS IN D:A:D
AHOD, Athena, Aquitaine, EuroSIDA, Icona, Nice, St. Pierre and Swiss.
D:A:D
STERING COMMITTEE MEETING
The next D:A:D SC face to face meeting will be held 28th February
2011at CROI in Boston.
GENERAL
INFORMATION
A
total of 49,737
patients are now included in the D:A:D study and are
under prospective follow-up. For the primary endpoints we now have
more
than 700 MIs and unfortunately 3500 persons have died. Last year we
asked you to prioritise events occurring in Cohorts I and II. From this
year we kindly ask you to prioritise all three cohorts equally.
RECENT PUBLICATIONS
1. HBV or HCV
co-infections and risk of myocardial infarction in HIV-infected
individuals: the D:A:D Cohort Study
Weber
R, Sabin C, Reiss P, de Wit S., Worm SW., Law M., Dabis F,
D´Arminio Moforte A, Fontas E, El-Sadr W, Kirk O, Rickenbach
M, Phillips A, Ledergerber B, Lundgren J.
Antivir Ther 2010;15 (8):1077-86
2. Rates of
Cardiovascular
Disease Following Smoking Cessation in Patients with HIV Infection:
Results from the D:A:D Study Petoumenos
K., Worm SW., Reiss P,, de Wit S., D’Arminio Monforte A.,
Sabin C., Friis-Moller N, Weber R., Mercie P., Pradier C., El-Sadr W.,
Kirk O.,Lundgren J., Law M., On behalf of the D:A:D Study Group HIV Med 2011 January 2
Epub ahead of print
RECENT PRESENTATIONS
The 12th International workshop on adverse drug reaction and
co-morbidities in HIV, London, November 2010: Oral presentation:
Evaluation of sudden
death
and non-haemorrhagic stroke and their
association with HIV protease inhibitor (PI) usage
Signe W. Worm, A
Kamara, P Reiss, E Fontas, S De Wit, W El Sadr, A d‘Arminio
Monforte, M Law, A Phillips, L Ryom, F Dabis, R Weber, C Sabin, JD
Lundgren on behalf of the D:A:D study
TWO POSTER HAVE BEEN
ACCEPTED AT IWHOD 24-26th 2011 of March in Prague
"Improving data quality in HIV cohort collaborations - exemplified by
the D:A:D study”
“Cancers or not? Collection and preliminary assessment of
non-AIDS-defining malignancies (NADMs) in the D:A:D Study”
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