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Synthesis of guidance available for assessing methodological quality and grading of evidence from qualitative research to inform clinical recommendations: a systematic literature review
Publication . Sekhon, Mandeep; de Thurah, Annette; Fragoulis, George E.; Schoones, Jan; Stamm, Tanja A.; Vlieland, Theodora P.M. Vliet; Esbensen, Bente Appel; Lempp, Heidi; Bearne, Lindsay; Kouloumas, Marios; Pchelnikova, Polina; Swinnen, Thijs Willem; Blunt, Chris; Ferreira, Ricardo J. O.; Carmona, Loreto; Nikiphorou, Elena
Objective: To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR). Methods: A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies. Results: Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid. Conclusion: There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.
"Fat-soluble vitamins in food supplements: do the labels follow the recommended doses?"
Publication . Costa, Isabel Margarida; Figueiredo, Alexandra; Moutinho, Guilhermina Martins; Auxtero, Maria Deolinda
Poster presented at the 3rd International Congress of CiiEM: Research and Innovation in Human & Health Sciences. Caparica, 20 june 2018
Remission definitions guiding immunosuppressive therapy in rheumatoid arthritis: which is best fitted for the purpose?
Publication . Duarte, Cátia; Ferreira, Ricardo J. O.; Welsing, Paco M.; Jacobs, Johannes W. G.; Gossec, Laure; Machado, Pedro M.; van der Heijde, Désirée; Silva, José António Pereira da
Objective: To assess which definition of remission best predicts good radiographic outcome (GRO) and good functional outcome (GFO) in rheumatoid arthritis, focusing the updated American College of Rheumatology/European Alliance of Associations for Rheumatology criteria. Material and methods: Meta-analyses of individual patient data (IPD) from randomised controlled trials (RCTs). Six definitions of remission were considered: (1) Boolean with Patient Global Assessment (PGA)≤1 (Boolean); (2) Simplified Disease Activity Index (SDAI)≤3.3; (3) Clinical Disease Activity Index (CDAI)≤2.8; (4) Boolean with PGA≤2 (Updated-Boolean); (5) Boolean with Physician Global Assessment (PhGA≤1) replacing PGA (Boolean-PhGA) and (6) Boolean excluding PGA (3VBoolean). GRO was defined as a worsening ≤0.5 units in radiographic score and GFO as a no worsening in Health Assessment Questionnaire (HAQ), that is, ∆HAQ-DI≤0.0 units. Relationships between each remission definition at 6 and/or 12 months and GRO and GFO during the second year were analysed. Pooled probabilities for each outcome for each definition and their predictive accuracy were estimated. Results: IPD from eight RCTs (n=4423) were analysed. Boolean, SDAI, CDAI, Updated-Boolean, Boolean-PhGA and 3VBoolean were achieved by 24%, 27%, 28%, 32%, 33% and 43% of all patients, respectively. GRO among patients achieving remission ranged from 82.4% (3VBoolean) to 83.9% (SDAI). 3VBoolean showed the highest predictive accuracy for GRO: 51.1% versus 38.8% (Boolean) and 44.1% (Updated-Boolean). The relative risk of GFO ranged from 1.16 (Boolean) to 1.05 (3VBoolean). However, the proportion of GFO correctly predicted was highest for the 3VBoolean (50.3%) and lowest for the Boolean (43.8%). Conclusion: 3VBoolean definition provided the most accurate prediction of GRO and GFO, avoiding the risk of overtreatment in a substantial proportion of patients without increment in radiographic damage progression, supporting the proposal that 3VBoolean remission is preferable to guide immunosuppressive treatment. The patient's perspective, which must remain central, is best served by an additional patient-oriented target: a dual-target approach.
An overview of Portugal's educational challenges and responses to the global pandemic of COVID-19
Publication . Costa, Filipa Alves da; Auxtero, Maria Deolinda; Martins, Ana Paula; Caramona, Maria Margarida
The current pandemic of SARS-CoV-2 came un-expectantly and required unprecedented ability to adapt and quickly put in place the most appropriate response measures to limit the spread of COVID-19 disease, while minimising disruption to society’s essential activities. Some sectors were more capable of adapting and reacting than others. Higher education was one of the sectors where the academic capacity (FIP Development Goal 1) demonstrated was phenomenal, partially attributable to the ability to create partnerships between academia and practice. This editorial provides a description of the major changes put in place in Portugal to ensure the education and training of future graduates in Pharmaceutical Sciences was maintained with the same quality. It also discusses some of the potentially less beneficial long-term impacts of these adaptions to the teaching and assessment methods for the competencies of the workforce of tomorrow.
Presentation of the first international research network to foster high-quality clinical trials testing non-pharmacological interventions (TRACTION network)
Publication . Ferreira, Ricardo J. O.; Henriques, Adriana; Moe, Rikke H.; Matos, Cristiano; Tveter, Anne-Therese; Osteras, Nina; Nogueira, Paulo; Costa, Andreia Silva; Haavardsholm, Espen A.; Carmona, Loreto; Richards, David
Clinical trials are essential for evaluating the efficacy and safety of new treatments and health interventions. However, while pharmacological trials are well-established, non-pharmacological trials face unique challenges related to their complexity and difficulties such as recruitment, retention, intervention standardisation, selection of outcome measures and blinding of clinicians, participants and data collectors. This communication paper describes the objectives, implementation steps and bylaws of the 'Trials foR heAlth Care inTerventIONs' Network (TRACTION), established by an international multiprofessional task force of experts to foster high-quality non-pharmacological research, ultimately improving patient care and healthcare outcomes.The TRACTION research network will provide information and resources through a collaborative hub for researchers, health professionals, patient research partners and stakeholders in diverse biomedical and healthcare areas, connecting people with different levels of expertise but with the same interests (eg, to evaluate the effect of non-pharmacological interventions, recruiting participants). This open network will support researchers in optimising trial design, participant recruitment, data management and analysis, and disseminating and implementing trial results.The network will also facilitate specialisation training and provide educational materials and mentoring.