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Loss to follow-up in registries of rheumatic patients treated with biologics : a potential information bias in assessing pharmacovigilance and efficacy outcomes

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dc.contributor.authorValido, Ana
dc.contributor.authorSilva-Dinis, Joana
dc.contributor.authorMachado, Ana Rita
dc.contributor.authorGonçalves, Maria João
dc.contributor.authorRomão, Vasco C.
dc.contributor.authorSaavedra, Maria João
dc.contributor.authorFonseca, João Eurico
dc.date.accessioned2021-03-04T17:15:00Z
dc.date.available2021-03-04T17:15:00Z
dc.date.issued2019
dc.description© 2001-2021 Sociedade Portuguesa de Reumatologia.pt_PT
dc.description.abstractBackground: The information associated with loss to follow-up (LFU) patients may affect real-world data evaluation of the use of biologics that is not being adequately captured in registries. Methods: We identified all patients(Pts) treated with biologics in our center who had no visits registered for more than 6 months, in the Rheumatic Diseases Portuguese Register, Reuma.pt. We retrieved baseline information from Reuma.pt and from the hospital electronic clinical record. We then performed a telephonic interview to characterize the reasons for LFU at our day care unit. For Pts unable to be contacted by telephone a letter of invitation to an appointment at the hospital was sent. Results: From a total of 794 Ptsregistered in Reuma.pt at our center with active biologic therapy 227 did not have any information registered in the last 6 months. Of this, 36 Pts were on biologic therapy prescribed by other departments and maintained follow-up in these departments. 102 Pts had suspended biologic administration by medical indication and this information was registered in the hospital electronic clinical records but not updated in Reuma.pt. For 89 Pts no information could be retrieved from either the hospital electronic clinical record or Reuma.pt and we classified these Pts as true LFU. 26 of these LFU Pts were being followed up in another Rheumatology center. 26 of the LFU Pts died. 11 Pts had an adverse effect. 4 Pts of the LFU were considering to be in remission. We were not able to contact 15 of the LFU pts. Conclusion: Identifying LFU Pts and clarifying the reason for the loss of data in a register contributes to a better knowledge on strategies to discontinue biologics in stable pts, to a better pharmacovigilance of adverse effects and to more efficiency in data capture by registries. Due to data protection reasons it was impossible to have access to the Pts's death certificates.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationActa Reumatol Port. 2019 Oct-Dec;44(4):281-287pt_PT
dc.identifier.issn0303-464X
dc.identifier.urihttp://hdl.handle.net/10451/46661
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSociedade Portuguesa de Reumatologiapt_PT
dc.relation.publisherversionhttp://www.actareumatologica.pt/pt_PT
dc.subjectLost to follow-uppt_PT
dc.subjectBiologicspt_PT
dc.subjectReuma.ptpt_PT
dc.titleLoss to follow-up in registries of rheumatic patients treated with biologics : a potential information bias in assessing pharmacovigilance and efficacy outcomespt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage287pt_PT
oaire.citation.issue4pt_PT
oaire.citation.startPage281pt_PT
oaire.citation.titleActa Reumatológica Portuguesapt_PT
oaire.citation.volume44pt_PT
person.familyNameMachado
person.familyNameGonçalves
person.familyNameC Romão
person.familyNameFonseca
person.givenNameAna Rita
person.givenNameMaria João
person.givenNameVasco
person.givenNameJoão
person.identifier426629
person.identifier490119
person.identifier.ciencia-id771D-0A5C-626B
person.identifier.ciencia-idF310-B85D-57C7
person.identifier.orcid0000-0003-0600-876X
person.identifier.orcid0000-0001-6461-9142
person.identifier.orcid0000-0002-5603-9436
person.identifier.orcid0000-0003-1432-3671
person.identifier.ridO-8224-2014
person.identifier.scopus-author-id55989452300
person.identifier.scopus-author-id7101983519
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication47fa1e23-6318-4e58-a2b8-addce384ea94
relation.isAuthorOfPublication447b803b-843b-4f1e-a7c4-6d53e2ba2013
relation.isAuthorOfPublicatione7e94139-add7-4a3b-b138-fb1d1a656b0e
relation.isAuthorOfPublication1772dc12-7c55-4c76-ae2d-c23270172480
relation.isAuthorOfPublication.latestForDiscovery447b803b-843b-4f1e-a7c4-6d53e2ba2013

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