Browsing by Author "Duarte-Ramos, Filipa"
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- Addressing challenges to enhance clinical research in Portugal: insights from the OncoT3 Expert Group Delphi StudyPublication . Resende, Catarina; Abreu, Marta; Presa Ramos, José; Carda, José; Costa, Luís; Cardoso, Fátima; Pereira, Deolinda; Teixeira, Encarnação; Tonin, Fernanda; Duarte-Ramos, FilipaIntroduction Over the past decades, clinical research has evolved significantly, driven by advances in regulatory frameworks, technological innovations, and methodological approaches. In Portugal, while there has been progress - such as increased regulatory alignment with European standards and the adoption of digital trial management tools - various challenges remain. These may include, among others, limited access to funding, slower patient recruitment rates, and regulatory hurdles that can delay trial approvals. Our goal was to identify key areas for improvement toward the optimization of clinical research practices in the country. Methods A modified three-round Delphi study was conducted online (2023-2024) to achieve a nationwide expert consensus. The scientific committee, composed of seven experts, developed 45 initial statements across five topics: dedication time to clinical research, organization of integrated research centers, conditions for implementing clinical trials, the role of institutional authorities, and patient recruitment and referral. A five-point Likert-type scale was used (1 - 'strongly disagree', 2 - 'disagree', 3 - 'neither agree nor disagree', 4 - 'agree', and 5 - 'strongly agree') to rate each statement. The consensus threshold was established as a percentage of agreement among participants (≥90% in the first round and ≥85% in the second round). The level of consensus achieved by the panel was discussed by the scientific committee during virtual meetings. Results Fifty-one experts completed the exercise (86.4% response rate). Consensus was reached on 32 of the 45 initial statements (71.1%) in the first round, with most of them (n = 20, or 62.5%) presenting high concordance rates (>95%). Four new statements were added for the second round, grounded on the feedback from the experts. By the end of the study, consensus was achieved on 45 out of the 49 final statements (91.8%), with the greatest agreement on the organization of integrated research centers and conditions for implementing clinical trials. Three statements regarding patient recruitment and referral, and one statement on the role of institutional authorities to promote clinical research, did not reach consensus, highlighting the need for further dialogue and innovative solutions in these fields. Conclusion The insights of this study can inform health organizations, regulatory agencies, and other stakeholders about the barriers and opportunities to improve clinical research in Portugal. By learning from global best practices and tailoring strategies to local contexts, the country can become a more prominent player in the international community.
- Correction: The meaning of lymphadenopathies during adjuvant durvalumab after chemoradiotherapy for lung cancer: thinking beyond disease progressionPublication . Pantarotto, Marcos; Barata, Rita; Coelho, Ricardo; Sousa, Virginia; Carvalheiro, Catarina; Rolim, Ines; Garrido, Patricia; GIl, Nuno; Duarte-Ramos, Filipa; Tonin, FernandaThis article has been corrected at the request of the authors to include Virginia Sousa as the fourth author as she was erroneously omitted during the submission process. The authors deeply regret that this error was not identified and addressed prior to publication.
- Experience and learning from the COVID-19 pandemic in Portugal: perceptions of community pharmacy professionalsPublication . Advinha, Ana Margarida; Santos, Margarida Custódio dos; Duarte-Ramos, Filipa; Perdigão, Margarida; Santos, Patricia; Oliveira-Martins, SofiaBackground: During the COVID-19 pandemic, community pharmacy (CP) professionals were among those who experienced the greatest risk of contracting SARS-CoV-2, which forced major adaptations. Objectives: The objectives of the study were to describe the changes implemented in CP professionals during the pandemic, understand the perception of professionals about their experience, and explore changes to remain. Methods: An observational and cross-sectional study was conducted via an online questionnaire (June–September 2020). The target population was CP professionals working in Portugal for >2 years and serving the public during the pandemic. Results: Of a total of 353 participants, 84% were female (mean age of 37.6 years), and 81% were pharmacists (mean professional experience of 12.9 years). In the management and organizational dimensions, the most mentioned changes were adaptation to legislative changes (90%), fluctuations in the treasury (82%), and reduction of working hours (46%). Only 2% resorted to simplified layoff. In the back office, there was a need to adapt stock management (93%) and purchase personal protective equipment (99%). In the front office, there was a change in service policies – wicket or conditional opening (92%), routes of the arrival of user requests (91%), and home delivery (82%). Physical changes occurred in 100% of pharmacies. The most frequently implemented procedures were the use of protection systems and PPE, articulation with hospital pharmacies for dispensing in proximity (75%), and training in this area (55%). Regarding interpersonal climate, improvements in the connection between team members are evident: increase in mutual help (57%), solidarity (54%), and group cohesion (50%); in the relationship with clients, the majority indicated the replacement of the usual user by third parties (71%), and changes in communication channels (increase in use of technological means 68%). Conclusions: Results illustrate the profound impact of the pandemic on CP professionals, both professionally and personally. It also highlights the importance of their roles in proximity and community support.
- The effects of benralizumab on lung volumes and airway resistance in severe eosinophilic asthma: a real-world studyPublication . Gerardo, António Madeira; Alves, Carolina da Silva; Gomes, Margarida; Pardal, Cecília; Sokolova, Anna; Liberato, Hedi; Mendes, Ana; Tonin, Fernanda; Duarte-Ramos, Filipa; Lopes, CarlosIntroduction: Add-on biological monoclonal antibodies such as benralizumab (anti-IL-5Ra) are recommended by international guidelines to reduce exacerbations in severe eosinophilic asthma (SEA). However, few studies have assessed the impact of these therapies on lung function-related outcomes. Our goal was to evaluate the effectiveness of benralizumab on lung function, including lung volumes and airway resistance, in SEA patients in Portugal. Methods: This was a real-world, observational, prospective, multicentric study including adult patients diagnosed with SEA (January-June 2023). Spirometry and plethysmography were performed at baseline (T0) and after six months of treatment (T6) with benralizumab to assess: total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), mean forced expiratory flow between 25% and 75% of FVC (mFEF-25/75), intrathoracic gas volume (ITGV), and respiratory airway resistance (Raw). Descriptive statistics (with categorical variables described as frequencies and continuous values as mean and standard deviation (SD)) and paired t-test and Cohen's d effect size were calculated (analyses performed in StataCorp v.15.1; StataCorp LLC, TX, USA). Results: Overall, 30 SEA patients were evaluated, mostly women (n=18, 60.0%), with atopy (n=22, 73.3%), a mean age of 58.4 years (SD 11.7), and assisted by pulmonology (n=19, 63.3%) or immunology-allergology (n=11, 36.7%) services. Mean eosinophilia at baseline was 1103.57 cells/mcL (SD 604.88; minimum-maximum 460-2400); after the use of benralizumab, the count dropped to zero. After six months of treatment, a significant increase (p<0.0001) in FVC (15.3%), FEV1 (22.6%), and mFEF-25/75 (17.7%) were observed from baseline (Cohen's d between 0.78 and 1.11). ITGV, RV, RV/TLC, and Raw significantly decreased (p<0.0001) during the study period (-17.3%, -29.7%, -8.9%, and -100.6%, respectively) (Cohen's d between -0.79 and -1.06). No differences in TLC were obtained (p=0.173). No differences between sexes were observed for any measure. Patients with more significant eosinophilia (>900 cells/mcL count; n=15) presented better responses in FEV1 (p=0.001) and mFEF-25/75 (p=0.007). Conclusions: A notable eosinophil depletion with add-on benralizumab led to significant improvements in SEA patients' respiratory function (static lung volumes and airway resistance) in real-world settings after six months. The significant deflating effect of benralizumab on patients' hyperinflated lungs led to enhanced expiratory flow (increased FEV1 and mFEF-25/75) and air trapping (decreased RV/TLC), suggesting this antibody improves bronchial obstruction, lung hyperinflation, and airway resistance. Further studies in a larger population are required to confirm these findings.
- The initial journey of patients with metastatic pancreatic cancer (PaCTO project): a nationwide survey among Portuguese specialist physiciansPublication . Barros, Anabela G.; Mansinho, Hélder; Couto, Nuno; Teixeira, Manuel R.; Tonin, Fernanda; Francisco, Rudolfo; Duarte-Ramos, FilipaABSTRACT - Introduction: We aimed to characterize the initial healthcare journey of metastatic pancreatic ductal adenocarcinoma (mPDAC) patients in Portugal, including healthcare provision and factors affecting therapeutic decisions, namely BRCA mutation testing. Methods: This is a descriptive cross-sectional, web-based survey using a convenience sampling approach. Portuguese oncologists and pathologists who routinely work with mPDAC patients from different geographical regions and settings were invited to participate in the study via email (December 2020). Descriptive statistical analyses were performed, with categorical variables reported as absolute and relative frequencies, and continuous variables with non-normal distribution as median and interquartile range (IQR) (Stata v.15.0). Results: Seventy physicians participated in the study (43 oncologists, 27 pathologists). According to the responses, a median of 28 patients per center (IQR 12–70) was diagnosed with PDAC in the previous year; 22 of them were referred (IQR 8–70) to mPDAC. The pointed median time from patients’ first hospital admission until disease diagnosis/staging is between 2 and 4 weeks. Endoscopic ultrasound with fine-needle biopsy is available in most hospitals (86%). Around 50% of physicians request BRCA testing; the assessment of additional biomarkers besides BRCA is requested by 40% of professionals. Half of them stated that BRCA testing should be requested earlier–upon histological diagnosis, especially because the median time for results is of 4.0 weeks (IQR 4–8). PARP inhibitors such as olaparib, when available, would be the therapy of choice for most oncologists (71%) if no disease progression occurs after 4 months. Treatment selection is usually grounded on clinical criteria (e.g., performance status, liver function). Around 45% of patients use FOLFIRINOX/mFOLFIRINOX as the first-line therapy. Gemcitabine + nab-paclitaxel is used by 35% of patients as the second-line therapy. Conclusions: Physicians in Portugal support the increasing role of patient-tailored treatments in mPDAC, whose selection should be grounded on tumoral subtyping and molecular profiling. Further efforts to develop multidisciplinary teams, standardize clinical practice, and optimize the implementation of new target therapies are needed.
- The meaning of lymphadenopathies during adjuvant durvalumab after chemoradiotherapy for lung cancer: thinking beyond disease progressionPublication . Pantarotto, Marcos; Barata, Rita; Coelho, Ricardo; Carvalheiro, Catarina; Rolim, Ines; Garrido, Patricia; GIl, Nuno; Duarte-Ramos, Filipa; Tonin, FernandaImmune-checkpoint inhibitors (ICIs) have become the mainstay of treatment for many malignancies. With this new strategy, relevant immune-related adverse events (irAEs) have been reported, some of which can be mistaken for disease progression. To better illustrate the current challenges in diagnosing and managing a patient under adjuvant ICI treatment, we present the case of a 67-year-old female patient with stage IIIB unresectable, epidermal growth factor receptor (EGFR)-mutated, non-small-cell lung cancer who was initially treated with chemoradiotherapy, followed by immunotherapy with durvalumab. During the course of immunotherapy, the patient presented with madarosis and erythematous and endured skin lesions, in addition to lymphadenopathies and pulmonary infiltrates. She was started on first-line palliative treatment with an EGFR tyrosine kinase inhibitor. After reviewing the case, a multidisciplinary team meeting suggested diagnostic procedures, including a transbronchial needle aspiration from mediastinal lymph nodes. The histologic examination showed chronic systemic inflammation and non-caseating granulomas of the sarcoid type. In this case, palliative treatment was suspended and systemic therapy with prednisolone was initiated. The patient became asymptomatic and the previously observed radiologic abnormalities resolved. This case highlights the importance of early recognition and appropriate treatment of irAEs, mainly because these conditions remain poorly understood and are probably underdiagnosed. Considering differential diagnosis is paramount to guide clinical management, despite curative or palliative treatment intent.