Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register
Authors: Mosconi Paola , Guerra Tommaso , Paletta Pasquale , D’Ettorre Antonio , Ponzio Michela , Battaglia Mario Alberto , Amato Maria Pia , Bergamaschi Roberto , Capobianco Marco , Comi Giancarlo , Gasperini Claudio , Patti Francesco , Pugliatti Maura , Ulivelli Monica , Trojano Maria , Lepore Vito ,   on behalf of the Italian Multiple Sclerosis and Related Disorders Register Centres Group, Aguglia U. , Amato MP. , Ancona AL. , Ardito B. , Avolio C. , Balgera R. , Banfi P. , Barcella V. , Barone P. , Bellantonio P. , Berardinelli A. , Bergamaschi R. , Bertora P. , Bianchi M. , Bramanti P. , Brescia Morra V. , Brichetto G. , Brioschi AM. , Buccafusca M. , Bucello S. , Busillo V. , Calchetti B. , Cantello R. , Capobianco M. , Capone F. , Capone L. , Cargnelutti D. , Carozzi M. , Cartechini E. , Cavaletti G. , Cavalla P. , Celani MG. , Clerici R. , Clerico M. , Cocco E. , Torri Clerici V. , Coniglio MG. , Conte A. , Corea F. , Cottone S. , Crociani P. , D’Andrea F. , Danni MC. , De Luca G. , de Pascalis D. , De Riz M. , De Robertis F. , De Rosa G. , De Stefano N. , Della Corte M. , Di Sapio A. , Docimo R. , Falcini M. , Falcone N. , Fermi S. , Ferraro E. , Ferrò MT. , Fortunato M. , Foschi M. , Gajofatto A. , Gallo A. , Gallo P. , Gatto M. , Gazzola P. , Giordano A. , Granella F. , Grasso MG. , Grimaldi LME. , Iaffaldano P. , Immovilli P. , Imperiale D. , Inglese M. , Iodice R. , Leva S. , Leuzzi V. , Lugaresi A. , Lus G. , Maimone D. , Mancinelli L. , Maniscalco GT. , Marfia GA. , Margari L. , Marinelli F. , Marini B. , Marson A. , Mascoli N. , Massacesi L. , Melani F. , Merello M. , Fioretti C. , Mirabella M. , Montepietra S. , Nasuelli D. , Nicolao P. , Pasquali L. , Passantino F. , Patti F. , Pecori C. , Peresson M. , Pesci I. , Piantadosi C. , Piras ML. , Pizzorno M. , Plewnia K. , Pozzilli C. , Protti A. , Quatrale R. , Realmuto S. , Ribizzi G. , Rinalduzzi S. , Rini A. , Romano S. , Filippi M. , Ronzoni M. , Rossi P. , Rovaris M. , Salemi G. , Santangelo G. , Santangelo M. , Leone A. , Sarchielli P. , Sinisi L. , Ferraro D. , Solaro C. , Spitaleri D. , Strumia S. , Tassinari T. , Santuccio G. , Tortorella C. , Totaro R. , Tozzo A. , Trivelli G. , Turano G. , Ulivelli M. , Valentino P. , Venturi S. , Vianello M. , Zaffaroni M. , Zarbo R. 
Published: June 2023

Introduction

Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked.

This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register.

Methods

The Register collects, through a standardized Web-based Application, unique patients.

Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated.

Results

The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients.

The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000–2015) to 60% (enrolment period 2016–2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2).

Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months.

Conclusions

Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.