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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!