gms | German Medical Science

Background and purpose: The German Multiple Sclerosis and Pregnancy Registry (DMSKW) is a national registry that monitors the course of pregnancy and disease in women with multiple sclerosis (MS). It is a prospective, observational, and voluntary cohort consisting mainly of patient-reported outcomes. Despite the great value for research, it has never been validated. Our objective was to assess data quality by evaluating the registry data's integrity, organisation and trueness.

Methods: A sample of data (n = 3780 datasets) from 11/2006-08/2023 was extracted from the DMSKW and evaluated using an extended source data verification method. A selection of variables that represent the main outcomes for the registry were chosen. This includes variables that describe disease activity before, during pregnancy and postpartum, the course of pregnancy and pregnancy outcomes. The data was evaluated on three levels of data quality: integrity, organisation and trueness, using certain data quality indicators (DQIs). Concordance of DMSKW vs. medical documentation, plausibility, missing values and accuracy were analysed. Kappa statistics and measures of validity were evaluated for the DQI concordance.

Results: Concordance between DMSKW vs. medical documentation was high for most variables (>90% agreement rate for 24/27 evaluated variables). The variables relapse post-partum (k=0.99, 95%CI: 0.98,1.0), premature birth (k=0.99, 95%CI:0.93,0.99) and high dose glucocorticoid treatment post-partum (k=0.99, 95%CI:0.96,1.0) had particularly high rates of concordance. The worst performing variables still birth (k=0.56, 95%CI: 0.12,1.0), head circumference (k=0.61,95%CI:0.53,0.7) and gestational age at birth (k=0.69,95%CI:0.61,0.90) had rates suggestive of moderate to substantial agreement respectively. Relapse in pregnancy (k=0.96,95%CI:0.92,0.99) and major congenital malformations (k=0.96,95%CI: 0.93,0.99) as two of the most important variables in the registry, reassuringly had very good rates of agreement. Of the three variables assessed on plausibility so far, no deviations from plausible values were identified for EDSS values and birth length, only one data entry error was identified for birthweight. The rate of missing values was low overall but was variable-dependent, ranging from a 0.36% rate of missing for last menstrual period to a 12% rate of missing for head circumference. The accuracy of the DMSKW data was high, with rates of relapse during pregnancy (16.3%), major congenital malformations (4.2%) and premature births (8.9%) comparable to similar cohorts in the MS population. Updated information will be presented at the time of the meeting.

Conclusion: Overall, the data quality of the DMSKW was considered good, with mostly substantial to very good levels of concordance between DMSKW data and medical documentation. Detected discrepancies were mainly due to the misclassification of outcomes, such as with still birth or missing knowledge of the correct terminology, such as with gestational age at birth. A high level of accuracy and low levels of missing values and implausible data further strengthened the validity of the data. The DMSKW data is a valid source of data for pharmacoepidemiologic evaluations and as a resource for neurologists and their consultations with MS patients.

KDK has nothing to disclose.SH has nothing to disclose. NB received payment for manuscript writing from Thieme. NF received speakers honoraria and a sponsorship for congress participation from Biogen GmbH. LW received travel grants from Novartis.TO has nothing to disclose. AR has nothing to disclose. RG has received speaker honoraria and research support from Bayer-Schering Healthcare, Biogen-Idec Germany, Chugai, Eisai, Merck Serono, Nikkiso Pharma, Novartis, Roche, Sanofi-Genzyme and TEVA, has received consulting honoraria from CSL Behring, Baxter, Janssen and Talecris and has stock options in Bayer, Merck and Roche. KH has received speaker honoraria and research support from Bayer, Biogen, Merck, Novartis, Sanofi-Genzyme, Roche and Teva, has received support for congress participation from Bayer, Biogen, Merck, Roche, Sanofi Genzyme and Teva, and has served on scientific advisory boards for Bayer, Biogen, Sanofi, Teva, Roche, Novartis and Merck.S.T. received speakers’ honoraria from Bayer Healthcare and Biogen GmbH, payment for manuscript writing from HEXAL AG as well as sponsorship for congress participation from Biogen GmbHThe German MS and pregnancy registry is partly supported by Almirall, Biogen, Hexal, Merck, Novartis, Roche, Sanofi Genzyme, Teva Pharma and Viatris.

The authors declare that an ethics committee vote is not required.