Repository logo

Unidade de Investigação Clínica

Permanent URI for this community

http://hdl.handle.net/10400.10/2320

Browse

Browsing Unidade de Investigação Clínica by Title

Now showing 1 - 6 of 6
  • Apoio estatístico à investigação clínica
    Publication . Herrero Valverde, A; Soares, P
    2019Conference object Open access Show more
  • Catarata pediátrica: a nossa experiência
    Publication . Roque, J; Basto, R; Lopes, AS; Silva, D; Pinto, S; Pires, G; Prieto, I
    2019Conference object Open access Show more
  • Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study
    Publication . de-Madaria, E; Sánchez-Marin, C; Carrillo, I; Vege, SS; Chooklin, S; Bilyak, A; Mejuto, R; Mauriz, V; Hegyi, P; Márta, K; Kamal, A; Lauret-Braña, E; Barbu, ST; Nunes, V, et al.
    Objective: This study aimed to develop and validate a patient-reported outcome measure (PROM) in acute pancreatitis (AP) as an endpoint centred on the patient. DESIGN: A PROM instrument (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, PAN-PROMISE scale) was designed based on the opinion of patients, professionals and an expert panel. The scale was validated in an international multicentre prospective cohort study, describing the severity of AP and quality of life at 15 days after discharge as the main variables for validation. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) methodology was applied. Both the design and validation stages considered the content and face validity of this new instrument; the metric properties of the different items, reliability (reproducibility and internal consistence), the construct, structural and criterion validity, responsiveness and interpretability of this scale. RESULTS: PAN-PROMISE consists of a seven-item scale based on the symptoms that cause the most discomfort and concern to patients with AP. The validation cohort involved 15 countries, 524 patients. The intensity of symptoms changed from higher values during the first 24 hours to lower values at discharge and 15 days thereafter. Items converged into a unidimensional ordinal scale with good fit indices. Internal consistency and split-half reliability at discharge were adequate. Reproducibility was confirmed using test-retest reliability and comparing the PAN-PROMISE score at discharge and 15 days after discharge. Evidence is also provided for the convergent-discriminant and empirical validity of the scale. CONCLUSION: The PAN-PROMISE scale is a useful tool to be used as an endpoint in clinical trials, and to quantify patient well-being during the hospital admission and follow-up.
    2020Journal article Restricted access Show more
  • Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting: PROTEC.
    Publication . Berger, T; Brochet, B; Brambilla, L; Giacomini, PS; Montalbán, X; Salgado, Salgado, AV, e outros
    Abstract BACKGROUND: Patient-reported outcomes (PRO) and clinical outcomes give a broad assessment of relapsing-remitting multiple sclerosis (RRMS) disease. OBJECTIVE: The aim is to evaluate the effectiveness of delayed-release dimethyl fumarate (DMF) on disease activity and PROs in patients with RRMS in the clinic. METHODS: PROTEC, a phase 4, open-label, 12-month observational study, assessed annualized relapse rate (ARR), proportion of patients relapsed, and changes in PROs. Newly diagnosed and early MS (≤3.5 EDSS and ≤1 relapse in the prior year) patient subgroups were evaluated. RESULTS: Unadjusted ARR at 12 months post-DMF versus 12 months before DMF initiation was 75% lower (0.161 vs. 0.643, p < 0.0001) overall (n = 1105) and 84%, 77%, and 71% lower in newly diagnosed, ≤3.5 EDSS, and ≤1 relapse subgroups, respectively. Overall, 88% of patients were relapse-free 12 months after DMF initiation (84%, newly diagnosed; 88%, ≤3.5 EDSS; 88%, ≤1 relapse). PRO measures for fatigue, treatment satisfaction, daily living, and work improved significantly over 12 months of DMF versus baseline. CONCLUSION: At 12 months after versus 12 months before DMF initiation, ARR was significantly lower, the majority of patients were relapse-free, and multiple PRO measures showed improvement (overall and for subgroups), suggesting that DMF is effective based on clinical outcomes and from a patient perspective.Clinical trial: A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC), NCT01930708,
    2019Journal article Open access Show more
  • 2019Conference object Open access Show more
  • Unidade de Investigação Clínica: UIC
    Publication . Herrero Valverde, A; Monteiro, E
    Sessão de apresentação da Unidade de Investigação Clínica (UIC), com a descrição da reorganização da Unidade, circuitos e procedimentos para o desenvolvimento de estudos clínicos. A segunda parte abordou essencialmente questões relacionadas com o tratamento de dados pessoais no âmbito da investigação clínica
    2018Conference object Open access Show more