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- Definitions and indexing of 'simulated patient’ studies in health: a classification system proposalPublication . Tonin, Fernanda; Pina, Isabela; Pontarolo, Roberto; Fernandez-Llimos, FernandoBackground information: Several inconsistencies in the definition and indexing of the term ‘simulated patient’ have been reported in the health literature, including in pharmacy practice. Purpose: To propose a classification system for studies on ‘simulated patient’ and to assess the coverage of ‘simulated patient’ in the National Library of Medicine’s (NLM) Medical Subject Headings (MeSH) thesaurus.
- Critical appraisal of dyslipidaemia clinical practice guidelines: a scoping reviewPublication . Deffert, Flávia; Tonin, Fernanda; Pontarolo, Roberto; Fernandez-Llimos, FernandoBackground information: Dyslipidaemia, the unbalanced level of lipoproteins and triglycerides, contributes to or aggravates cardiovascular diseases. In 2019, high LDL-c levels were responsible for 5 million deaths worldwide. Several clinical practice guidelines (CPG) about dyslipidaemia aiming at guiding healthcare professionals towards more assertive decisions exist. However, previous studies reported low quality of the clinical content and evidence supporting recommendations provided by CPGs in different areas, and a lack of involvement of multi-professional experts and stakeholders, such as pharmacists, in their development. This may lead to inconsistencies and risk of bias in decision-making and negatively impact patients’ outcomes. The quality of CPG can be assessed through Appraisal of Guidelines, Research and Evaluation (AGREE) tools as the AGREE II (methodological assessment) and AGREE REX (clinical recommendations). Purpose: We aim to evaluate the quality of available CPG on dyslipidaemia and assess the extent of involvement of stakeholders using AGREE II and AGREE REX appraisal tools.
- Efficacy and safety of pharmacological interventions for managing sickle cell disease in children and adolescents: protocol for a systematic review with network meta-analysisPublication . Tonin, Fernanda; Ginete, Catarina; Fernandez-Llimos, Fernando; Ferreira, Joana; Delgadinho, Mariana; Brito, MiguelIntroduction: Sickle cell disease (SCD), an inherited haemoglobinopathy, has an important impact on morbidity and mortality, especially in paediatrics. Previous systematic reviews are limited to adult patients or focused only on a few therapies. We aim to synthesise the evidence on the efficacy and safety of pharmacological interventions for managing SCD in children and adolescents. Methods and analysis: This systematic review protocol is available at Open Science Framework (doi:10.17605/OSF.IO/CWAE9). We will follow international recommendations on the conduction and report of systematic reviews and meta-analyses. Searches will be conducted in PubMed, Scopus, and Web of Science (no language nor time restrictions) (first pilot searches performed in May 2022). We will include randomised controlled trials comparing the effects of disease-modifying agents in patients with SCD under 18 years old. Outcomes of interest will include: vaso-occlusive crisis, haemoglobin levels, chest syndrome, stroke, overall survival, and adverse events. We will provide a narrative synthesis of the findings, and whenever possible, results will be pooled by means of pairwise or Bayesian network meta-analyses with the surface under the cumulative ranking curve analyses. Different statistical methods and models will be tested. Dichotomous outcomes will be reported as OR, risk ratio, or HR, while continuous data will be reported as standard mean differences, both with 95% CI/credibility interval. The methodological quality of the trials will be evaluated using the Risk of Bias 2.0 tool, and the certainty of the evidence will be assessed with the Grading of Recommendations Assessment, Development, and Evaluation approach. Ethics and dissemination: This study refers to a systematic review, so no ethics approval is necessary. We intend to publish our findings in an international, peer-reviewed journal. Data will also be presented to peers at scientific events. Additionally, the results obtained in this study may contribute towards the update of therapeutic guidelines and the development of health policies for SCD.
- Efficacy and safety of daily treatments for drug-susceptible pulmonary tuberculosis: a systematic review and network meta-analysisPublication . Imazu, Priscila; Santos, Josiane M.; Beraldi-Magalhães, Francisco; Fernandez-Llimos, Fernando; Tonin, Fernanda; Pontarolo, RobertoObjectives: To evaluate and update the evidence on the comparative efficacy and safety of antimicrobial drugs regimens for treating pulmonary drug-susceptible tuberculosis (DS-TB). Methods: A systematic review was performed with searches in PubMed and Scopus (PROSPERO-CRD42019141463). We included randomised controlled trials comparing the effect of any antimicrobial regimen lasting at least 2 weeks. The outcomes of interest were culture conversion and incidence of adverse events. Bayesian network meta-analyses and surface under the cumulative ranking curve (SUCRA) analyses were performed. Results were reported as odds ratio with 95% credibility intervals. Key findings: Fifteen studies were included in the meta-analysis (n = 7560 patients). No regimen was statistically more effective than the WHO standard approach (rifampicin, isoniazid, ethambutol, and pyrazinamide). The use of rifapentine 450 mg instead of rifampicin in the standard regimen demonstrated to be statistically safer than all other options for serious adverse events (e.g. hepatotoxicity, arthralgia) (OR ranging from 0.0 [Crl 0.00-0.04] to 0.0 [0.00-0.97]; SUCRA probabilities of 10%). Therapies containing rifapentine (Rp1500HEZ, Rp900HEZ) and moxifloxacin (RMEZ, RHMZ) are effective regarding culture conversion, but statistical uncertainty on their safety profile exists. Conclusion: The WHO standard regimen remains an overall effective and safe alternative for DS-TB. For intensive phase treatments, drugs combinations with rifapentine and moxifloxacin seem to reduce treatment duration while maintaining efficacy.
- Complexidade do regime terapêutico geriátrico: doentes institucionalizados versus doentes em ambulatórioPublication . Advinha, Ana; Soares, Maria Augusta; Mateus, Vanessa; Graça, Anabela; Pajote, Sara Grou; Lopes, Manuel José; Fernandez-Llimos, Fernando; Cabrita, José; Morais, JoséO envelhecimento populacional representa um fenómeno demográfico crescente e um importante problema social, o que tem despoletado o interesse dos investigadores pela geriatria e pela gerontologia. A falta de suporte doméstico, familiar e social pode muitas vezes conduzir a problemas de adesão e gestão da terapêutica nos idosos. Por vezes, o internamento em lares de terceira idade constitui o único meio de obtenção de cuidados de saúde de que necessitam. O envelhecimento surge também acompanhado por alterações fisiológicas, metabólicas e funcionais que conduzem a alterações farmacocinéticas e farmacodinâmicas. As múltiplas patologias do idoso associam-se inevitavelmente à toma de medicamentos que muitas vezes resulta em polimedicação. Com o aumento de consumo de medicamentos e a diminuição das capacidades do idoso para gerir a sua terapêutica, torna-se fundamental efectuar a determinação da complexidade do regime terapêutico, tanto pelas implicações em termos de adesão à medicação como pelos resultados clínicos. A complexidade do regime terapêutico de um indivíduo caracteriza-se por ser um elemento conciliador de diversos factores da sua farmacoterapia, como sejam, o número de medicamentos tomados, as formas farmacêuticas, as frequências de dose e as indicações adicionais.
- The International Collaboration of Pharmacy Journal Editors (ICPJE) formally constituted to foster quality around clinical and social pharmacy practice research publicationsPublication . Alves da Costa, F.; Fernandez-Llimos, Fernando; Desselle, S.; Arnet, I.; Babar, Z.; Bond, C.; Cordina, M.; Garcia Cardenas, V.; El Hajj, M. S.; Jacobsen, R.; Law, A. V.; Nørgaard, L. S.; Polidori, C.; Shcherbakova, N.; Stewart, D.; Tonin, Fernanda; Weidmann, A. E.The Granada statements were a result of the need to strengthen clinical, social, and administrative pharmacy practice as an area of knowledge that translates into practice, research,h and policy. As a response, a group of clinical and social pharmacy practice journal editors launched an initiative in Granada in 2023, to discuss ways to improve the quality of publications in this area, culminating in the Granada statements. Eighteen statements were developed, clustered into six main domains: (1) the appropriate use of terminology; (2) developing impactful abstracts; (3) having the required peer reviews; (4) journal scattering; (5) more effective and wiser use of journal and article performance metrics; and (6) authors’ selection of the most appropriate pharmacy practice journal to submit their work. The full Granada statements have been published in 14 journals. These pioneering statements are rooted in similar endeavors undertaken by scholars in other health professions groups, fostering the concept of interdisciplinary consensus and advancing the scientific paradigm.
- The International Collaboration of Pharmacy Journal Editors (ICPJE) formally constituted to foster quality around clinical and social pharmacy practice research publicationsPublication . Alves da Costa, Filipa; Fernandez-Llimos, Fernando; Desselle, Shane; Arnet, Isabelle; Babar, Zaheer; Bond, Christine; Cordina, Maria; Garcia Cardenas, Victoria; El Hajj, Maguy S.; Jacobsen, Ramune; Law, Anandi V.; Norgaard, Lotte S.; Polidori, Carlo; Shcherbakova, Natalia; Stewart, Derek; Weidmann, Anita E.; Tonin, FernandaThe Granada statements were a result of the need to strengthen clinical, social, and administrative pharmacy practice as an area of knowledge that translates into practice, research, and policy. As a response, a group of clinical and social pharmacy practice journal editors launched an initiative in Granada in 2022 to discuss ways to improve the quality of publications in this area, which culminated in the Granada statements. Eighteen statements were developed, clustered into six main domains: 1) the appropriate use of terminology; 2) developing impactful abstracts; 3) having the required peer reviews; 4) preventing journal scattering; 5) more effective and wiser use of journal and article performance metrics; and 6) authors’ selection of the most appropriate pharmacy practice journal to submit their work. The full Granada statements have been published in 14 journals. These pioneering statements are rooted in similar endeavours undertaken by scholars in other health professions groups, fostering the concept of interdisciplinary consensus and advancing scientific paradigm.
- The International Collaboration of Pharmacy Journal Editors (ICPJE) formally constituted to foster quality around clinical and social pharmacy practice research publicationsPublication . Alves da Costa, F.; Fernandez-Llimos, Fernando; Desselle, S.; Arnet, I.; Babar, Z.; Bond, C.; Cordina, M.; Garcia Cardenas, V.; El Hajj, M. S.; Jacobsen, R.; Law, A. V.; Nørgaard, L. S.; Polidori, C.; Shcherbakova, N.; Stewart, D.; Weidmann, A. E.; Tonin, FernandaThe Granada statements were a result of the need to strengthen clinical, social, and administrative pharmacy practice as an area of knowledge that translates into practice, research, and policy. As a response, a group of clinical and social pharmacy practice journal editors launched an initiative in Granada in 2022 to discuss ways to improve the quality of publications in this area, which culminated in the Granada statements. Eighteen statements were developed, clustered into six main domains:1) the appropriate use of terminology; 2) developing impactful abstracts; 3) having the required peer reviews; 4) preventing journal scattering; 5) more effective and wiser use of journal and article performance metrics; and 6)authors’ selection of the most appropriate pharmacy practice journal to submit their work. The full Granada statements have been published in 14 journals. These pioneering statements are rooted in similar endeavors undertaken by scholars in other health professions groups, fostering the concept of interdisciplinary consensus and advancing scientific paradigms.
- The International Collaboration of Pharmacy Journal Editors (ICPJE) formally constituted to foster quality around clinical and social pharmacy practice research publicationsPublication . Alves da Costa, F.; Fernandez-Llimos, Fernando; Desselle, S.; Arnet, I.; Babar, Z.; Bond, C.; Cordina, M.; Garcia Cardenas, V.; El Hajj, M. S.; Jacobsen, R.; Law, A. V.; Nørgaard, L. S.; Polidori, C.; Shcherbakova, N.; Stewart, D.; Tonin, Fernanda; Weidmann, A. E.The Granada statements were a result of the need to strengthen clinical, social, and administrative pharmacy practice as an area of knowledge that translates into practice, research, and policy. As a response, a group of clinical and social pharmacy practice journal editors launched an initiative in Granada in 2023, to discuss ways to improve the quality of publications in this area, which culminated in the Granada statements. Eighteen statements were developed, clustered into six main domains: (i) the appropriate use of terminology; (ii) developing impactful abstracts; (iii) having the required peer reviews; (iv) journal scattering; (v) more effective and wiser use of journal and article performance metrics; and (vi) authors’ selection of the most appropriate pharmacy practice journal to submit their work. The full Granada statements have been published in 14 journals. These pioneering statements are rooted in similar endeavors undertaken by scholars in other health professions groups, fostering the concept of interdisciplinary consensus and advancing the scientific paradigm.
- La International Collaboration of Pharmacy Journal Editors (ICPJE) se constituye formalmente para fomentar la calidad en torno a las publicaciones de investigación sobre farmacia práctica, clínica y socialPublication . Alves da Costa, Filipa; Fernandez-Llimos, Fernando; Desselle, Shane; Arnet, Isabelle; Babar, Zaheer; Bond, Christine; Cordina, Maria; Garcia Cardenas, Victoria; El Hajj, Maguy S.; Jacobsen, Ramune; Law, Anandi V.; Nørgaard, Lotte S.; Polidori, Carlo; Shcherbakova, Natalia; Stewart, Derek; Tonin, Fernanda; Weidmann, Anita E.La declaración de Granada fue el resultado de la necesidad de fortalecer la farmacia práctica clínica, social y administrativa como un área de conocimiento que se materialice en la práctica, la investigación y la política. Para ello, un grupo de editores de revistas de farmacia práctica, clínica y social puso en marcha en el año 2022 en Granada una iniciativa para discutir formas de mejorar la calidad de las publicaciones en esta área, y que culminó en el documento denominado Declaración de Granada. Se desarrollaron dieciocho recomendaciones, agrupadas en seis ámbitos principales: 1) uso apropiado de la terminología; 2) elaborar resúmenes impacto 3) necesidad de las revisiones por pares; 4) limitar la dispersión de revistas; 5) uso más efectivo y adecuado de las métricas de impacto de revistas y artículos; y 6) selección por los autores de la revista de farmacia práctica más apropiada para publicar su trabajo. La declaración de Granada ha sido publicada íntegramente en 14 revistas. Este documento pionero tiene sus antecedentes en otras iniciativas similares desarrolladas por académicos de otros grupos de profesiones de la salud, fomentando el concepto de consenso interdisciplinar y avanzando en el paradigma científico.