RESUMO
OBJECTIVE: To determine the influence of radiographic examination on the recommendations made at the time of planned re-evaluation of dogs after medial patellar luxation (MPL) surgery. STUDY DESIGN: Retrospective multi-institutional case series. ANIMALS: Client-owned dogs (N = 825) that underwent MPL surgery. METHODS: Records of 10 referral institutions were searched for dogs that had been treated surgically for unilateral MPL and underwent a planned follow-up visit, including radiographs. The frequency of, and reasons for, changes in further recovery recommendations were investigated. RESULTS: Follow up was performed at a median of 6 (range, 4-20) weeks postoperatively. Isolated radiographic abnormalities were identified in 3.3% (27/825) of dogs following MPL surgery and led to a change in recommendations in 3% (13/432) of dogs that were presented without owner or clinician concerns. Lameness, administration of analgesia at follow up, and history of unplanned visits prior to routine re-examination were associated with a change in postoperative plan (P < .001). In the absence of owner and clinician concerns, the odds of having a change in convalescence plans were not different, whether or not isolated radiographic abnormalities were present (P = .641). CONCLUSION: Routine radiographs at follow up did not influence postoperative management of most dogs after MPL surgery in the absence of abnormalities on clinical history or orthopedic examination. CLINICAL SIGNIFICANCE: Dogs that were presented for routine follow up after unilateral MPL surgery without owner concerns, lameness, analgesic treatment or a history of unplanned visits, and for which examination by a surgical specialist was unremarkable, were unlikely to benefit from radiographs.
Assuntos
Doenças do Cão , Luxação Patelar , Animais , Cães , Doenças do Cão/diagnóstico por imagem , Doenças do Cão/cirurgia , Seguimentos , Coxeadura Animal/diagnóstico por imagem , Coxeadura Animal/cirurgia , Luxação Patelar/diagnóstico por imagem , Luxação Patelar/cirurgia , Luxação Patelar/veterinária , Estudos Retrospectivos , Joelho de Quadrúpedes/diagnóstico por imagem , Joelho de Quadrúpedes/cirurgiaRESUMO
PURPOSE: Literature reports of adverse drug events can be replicated across multiple companies, resulting in extreme duplication (defined as a majority of reports being duplicates) in the FDA Adverse Event Reporting System (FAERS) database because they can escape legacy duplicate detection algorithms routinely deployed on that data source. Literature reference field, added to in 2014, could potentially be utilized to identify replicated reports. FAERS does not enforce adherence to the Vancouver referencing convention, thus the same article may be referenced differently leading to duplication. The objective of this analysis is to determine if variations of the same literature references observed in FAERS can be resolved with text normalization and fuzzy string matching. METHODS: We normalized the literature references recorded in the FAERS database through the first quarter of 2021 with a rule-based algorithm so that they better conform to the Vancouver convention. Levenshtein distance was then utilized to merge sufficiently similar normalized literature references together. RESULTS: Normalization of literature references increases the percentage that can be parsed into author, title, and journal from 61.74% to 93.93%. We observe that about 98% of pairs within groups do have a Levenshtein similarity of the title above the threshold. The extreme duplication ranged from 66% to 87% with a median of 72% of reports being duplicates and often involved addictovigilance scenarios. CONCLUSIONS: We have shown that these normalized references can be merged via fuzzy string matching to improve enumeration of all the individual case safety reports that refer to the same article. Inclusion of the PubMed ID and adherence to the Vancouver convention could facilitate identification of duplicates in the FAERS dataset. Awareness of this phenomenon may improve disproportionality analysis, especially in areas such as addictovigilance.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Estados Unidos , Humanos , United States Food and Drug Administration , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Algoritmos , SoftwareRESUMO
INTRODUCTION: Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. The unprecedented environment created by the coronavirus disease 2019 (COVID-19) pandemic for vaccine surveillance predisposes commonly applied signal detection methodologies to a statistical issue called the masking effect, in which signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines. OBJECTIVE: The aim is to investigate the problem of masking in the context of COVID-19 vaccine signal detection, assessing its impact, extent, and root causes. METHODS: Based on data underlying the Vaccine Adverse Event Reporting System, three commonly applied statistical signal detection methodologies, and a more advanced regression-based methodology, we investigate the temporal evolution of signals corresponding to five largely recognized adverse events and two potentially new adverse events. RESULTS: The results demonstrate that signals of adverse events related to COVID-19 vaccines may be undetected or delayed due to masking when generated by methodologies currently utilized by pharmacovigilance organizations, and that a class of advanced methodologies can partially alleviate the problem. The results indicate that while masking is rare relative to all possible statistical associations, it is much more likely to occur in COVID-19 vaccine signaling, and that its extent, direction, impact, and roots are not static, but rather changing in accordance with the changing nature of data. CONCLUSIONS: Masking is an addressable problem that merits careful consideration, especially in situations such as COVID-19 vaccine safety surveillance and other emergency use authorization products.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Sistemas de Notificação de Reações Adversas a Medicamentos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Farmacovigilância , Vacinas/efeitos adversosRESUMO
The objective of this study was to assess the variables associated with complications of total hip replacement (THR) and report owner-assessed outcomes. Entries into the British Veterinary Orthopaedic Association-Canine Hip Registry (BVOA-CHR) between September 2011 and December 2012 were reviewed separately and in conjunction with previous data (January 2010-August 2011). An outcomes assessment questionnaire was used to collect data from owners. Incidences of surgeon-reported and owner-reported complications were 8.2 per cent and 4.3 per cent, respectively. THR using the BioMedtrix BFX cup/stem prosthesis had a greater incidence of complications compared with THR using the BioMedtrix CFX cup/stem prosthesis (P=0.002); complications were 4.48 times more likely when using the BioMedtrix BFX cup/stem prosthesis versus the BioMedtrix CFX cup/stem prosthesis. THR using the BioMedtrix BFX cup/stem prosthesis had a higher incidence of complications compared with THR using a hybrid prosthesis (BioMedtrix BFX cup/CFX stem, BioMedtrix CFX cup/BFX stem) (P=0.046); complications were 2.85 times more likely when using the BioMedtrix BFX cup/stem prosthesis versus a hybrid prosthesis. In 95 per cent of cases, owner satisfaction with the outcome of THR was 'very good' or 'good'. Complication rates from the BVOA-CHR are similar to previous studies. The data suggest that prosthesis type is associated with complication rate, with BioMedtrix BFX (circa 2012) having a high short-term complication rate.