Browsing by Author "Pimentel-Santos, FM"
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- Prognostic factors for recovery and non-recovery in patients with non-specific neck pain: a protocol for a systematic literature reviewPublication . Domingues, L; Cruz, EB; Pimentel-Santos, FM; Ramiro, S; Donato, H; Manica, SR; Hayden, JA; Buchbinder, R; Branco, JCINTRODUCTION: Neck pain is a common musculoskeletal disorder worldwide. It can result in significant disability and impaired quality of life. More than 50% of patients with neck pain still report symptoms 1 year later despite receiving different forms of non-pharmacological and pharmacological treatment. Identifying patient characteristics that are modifiable or predict recovery and non-recovery for an individual patient might identify ways of improving outcomes. This systematic review aims to comprehensively summarise the existing evidence regarding baseline patient characteristics associated with recovery and non-recovery, as defined by measures of pain intensity, disability and global perceived improvement. METHODS AND ANALYSIS: Six electronic databases, PubMed, CINAHL, PEDro Database, EMBASE, Cochrane Library and Web of Science, will be searched, with terms related to the review question such as neck pain, prognostic or predictive research, from inception to 28 September of 2018. Studies will be included if they have investigated an association between patient characteristics and outcomes, with at least one follow-up time point. Two independent reviewers will screen the titles and abstracts followed by a full-text review to assess papers regarding their eligibility. Data from included papers will be extracted using standardised forms, including study and participants' characteristics, outcomes, prognostic factors and effect size of the association. The risk of bias of each study will be assessed using the Quality in Prognostic Studies tool. A narrative synthesis will be conducted considering the strength, consistency of results and the methodological quality. ETHICS AND DISSEMINATION: This systematic review does not require ethical approval. The results will be disseminated through publication in a peer-review journal, as a chapter of a doctoral thesis and through presentations at national and international conferences.
- The Portuguese Society of Rheumatology position paper on the use of biosimilarsPublication . Fonseca, JE; Gonçalves, J; Araújo, F; Cordeiro, I; Teixeira, F; Canhão, H; Pereira da Silva, JA; Garcês, S; Miranda, LC; Ramiro, Sofia; Roxo, Ana; Pimentel-Santos, FM; Tavares, V; Neto, A; Sepriano, A; Malcata, A; Faustino, A; Silva, C; Ambrósio, C; Duarte, C; Miguel, C; Barcelos, F; Santos, H; Cunha, I; Ramos, JC; Melo-Gomes, JA; Pimentão, JB; Costa, L; Maurício, L; Silva, M; Bernardes, M; Bogas, M; Coelho, PC; Monteiro, P; Aguiar, R; André, R; Leitão, R; Pimenta, S; Meirinhos, T; Fernandes, S; Las, V; Castelão, WBiotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.