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DeSScipher – To decipher the optimal management of
systemic sclerosis
Grant agreement n° 305495
Start Date: 01/12/2012 - Duration: 36 months
Coordinator: Prof. Ulf Müller-Ladner, JLU Giessen
TELEPHONE CALL
DESSCIPHER WORKPACKAGE 1: REVIEW OF E-CRFS
31.01.2013
Minutes of the meeting
Document history
When
Who
Comments
31.01.2013
Séverine Lacharme-Reichert
1st draft
31.01.2013
Ingo Tarner
Revision of 1st draft
31.01.2013
Séverine Lacharme-Reichert
Final version included remarks (green
highlighted) from Gabriele Valentini and
Yannick Allanore received per email.
Participants list
Part.
no.
1
2
3
4
5
6
7
8
9
10
11
12
13
Participant organisation name
Ulf Müller-Ladner
Ingo Tarner
Marc Frerix
Uli Walker
Veronika Jäger
Laszlo Czirjak
Marco Matucci-Cerinic
Chris Denton
Serena Vettori
Jörg Umbricht
Séverine Lacharme-Reichert
Elise Siegert
Note: Actions are yellow highlighted.
Part. Short
Name
JLU Giessen
JLU Giessen
JLU Giessen
Uni Basel
Uni Basel
PECS
Uni Firenze
UCL
UNINA2
New Win
Novamen
Charité
TC WP1: Review of e-CRFs, 31.01.2013
Minutes of the meeting
DeSScipher
Agenda + notes
8.00
Welcome and update about completeness of data model
8.05
Participation of centers into Desscipher substudies
 All DeSScipher centers should/could take part in all substudies
8.10
Recruitment of individual patients into a Desscipher substudy:
Two possibilities:
a) It is asked immediately when a visit is documented whether the patient can be recruited into a
substudy
b) Eligibility of a patient is checked by means of routine MEDS fields (or similar obligatory fields). Once
the patient is found eligible, additional data entry fields are displayed.
Advantage: perhaps less duplicate entries, less time consuming, easier to maintain a routine?
 Choice of the option b).
Moreover, the log in before documenting data will be made through a center number, recognition as
Desscipher center
8.20
-
Questionnaires:
Which ones?
 It was a common decision that not all questionnaires are necessary, but all questionnaires that
represent a pre-defined primary or secondary outcome are indispensable.
Each of the OT leaders has to be sure that all primary outcomes are in! Red ones are the mandatory
one, everything else is nice to have but not mandatory.
To keep in any case: Cochin/CDAI/HAQ/CHAQ
Are the centers interested in the option of documenting patient questionnaires online using
tablet PCs?
 It depends on the center (for the middle European centers could be difficult) but most participants
felt that the use of this option would decrease the work-load. Each center should provide for itself a
tablet or should give the opportunity to the patient to fill-in the questionnaire online on site using an
office PC.
-
To be documented by paper?
Languages?
 All non-English speaking OT leaders should send translations of the questionnaires to Uli
8.30
Medications
 What about the green and yellow items?
Would it be better to just have a choice of yes/no/not documented or to have a drop-down list?
Will it hurt to have a lot of data missing? Will it compromise the DeSScipher results? It was felt that it
will be best to keep a clean list and to have less medication lines.
 Are there some mistakes in the list?
Several drugs are not necessary for every OT but specific to some OTs only. Therefore, it was asked
whether we want to specifically allocate particular drugs to particular OT or document all drugs for all
OTs. It was decided that it is better to have the same set of medication for all visits and then filtering
options instead pre-defining specific sets for specific OTs. This may also be helpful later with regard to
publications.
TC WP1: Review of e-CRFs, 31.01.2013
Minutes of the meeting
DeSScipher
Finally it was decided that drugs marked in green in Veronika’s merged list are not mandatory so that
they will not become part of the dataset.
 Should the start and stop dates of drug treatment be documented?
It was felt that the exact day does not matter but the month and year should be recorded.
 Should the exact dosage be recorded?
The dose should be documented when it has a special impact on the patient’s health or the proposed
outcome parameters. At least the dosage ranges which are expected to have an impact should be
provided. The OT leaders are requested to decide on this point.
Request arising:
 Should the reasons for discontinuation or changing of a drug be recorded?
Consider the requests (dose + impact of stopping/adding treatment) especially for the drugs marked
as important in the excel file (F-K columns marked with letters). Since discontinuation of a drug is a
safety outcome parameter in most OTs, recording of the reasons for discontinuation is strongly
advised.
8.40
Other data
All items marked in green can be deleted. Regarding the items marked in yellow, a consensus was
reached during the TC:
 Discussion on localization of DU (453): for Marco not to be deleted. What about the graph to
produce? A graph? a map?
Francesco should answer this question and give some solution as soon as possible. As a simple
alternative a list of the most important localizations to be ticked (finger tips/dorsal/proximal) has
been suggested. The final decision should come from Marco and Francesco.
 Some items from Laszlo’s list can be left out
Laszlo and Chris agreed to review those items among them and Laszlo will email directly to
Veronika and Uli
 Consensus on particular items to be left out:
86/ 92/ 96/ 110/ 703/ 399/398/748/751/761/784
Yannick adds some items to be deleted: 584/586/588 but he would like to keep 751/761/776. A
final consensus has to be found for the items 751 and 761.
 Idea: Why not try the consensus dataset on a sample patient in order to be sure that it works?
Problem: Zürich should have a look at the list before implementation by New Win and the deadline
for delivery of the final datamodel to New Win is February 08. Thus, there is most likely not
enough time to test the dataset.
 Should or can there be a required number of patient visits per year?
One visit per year can be acceptable. Since the project is based on observational trials and not
interventional, no mandatory frequency of patients’ visit can be implemented.
Gabriele underlines the need for a strict follow-up (three-month visit and ECG; six-month echo and
yearly Holter ECG) for patients at risk for SHD i.e. diffuse-anti-Scl-70 positive patients while visit
and ECG could be made every six months in the remaining enrolled patients.
OT leaders can inquire at the centers on a regular basis whether any new data has been recorded.
8.55
Miscellaneous
-
Pediatric module
 Discussion with Ivan to follow up this point.
TC WP1: Review of e-CRFs, 31.01.2013
-
Minutes of the meeting
DeSScipher
Wrap up
Important point:
At LATEST New Win should receive all info/criteria to be implemented on the 8 th of February
2013. The decisions process (OT leaders --> Uni Basel --> Uni Zürich) should be completed
until then.
Thank you for your participation!