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- Patient preferences and cost-benefit of hypertension and hyperlipidemia collaborative management model between pharmacies and primary care in Portugal: A discrete choice experiment alongside a trial (USFarmácia®)Publication . Costa, Suzete; Guerreiro, José; Teixeira, Inês; Helling, Dennis K.; Mateus, Céu; Pereira, JoãoBackground: Little is known about patient preferences and the value of pharmacy-collaborative disease management with primary care using technology-driven interprofessional communication under real-world conditions. Discrete Choice Experiments (DCEs) are useful for quantifying preferences for non-market services. Objectives: 1) To explore variation in patient preferences and estimate willingness-to-accept annual cost to the National Health Service (NHS) for attributes of a collaborative intervention trial between pharmacies and primary care using a trial exit DCE interview; 2) to incorporate a DCE into an economic evaluation using cost-benefit analysis (CBA). Methods: We performed a DCE telephone interview with a sample of hypertension and hyperlipidemia trial patients 12 months after trial onset. We used five attributes (levels): waiting time to get urgent/not urgent medical appointment (7 days/45 days; 48 hrs./30 days; same day/15 days), model of pharmacy intervention (5-min. counter basic check; 15-min. office every 3 months for BP and medication review of selected medicines; 30-min. office every 6 months for comprehensive measurements and medication review of all medicines), integration with primary care (weak; partial; full), chance of having a stroke in 5 years (same; slightly lower; much lower), and annual cost to the NHS (0€; 30€; 51€; 76€). We used an experimental orthogonal fractional factorial design. Data were analyzed using conditional logit. We subtracted the estimated annual incremental trial costs from the mean WTA (Net Benefit) for CBA. Results: A total of 122 patients completed the survey. Waiting time to get medical appointment-on the same day (urgent) and within 15 days (non-urgent)-was the most important attribute, followed by 30-minute pharmacy intervention in private office every 6 months for point-of-care measurements and medication review of all medicines, and full integration with primary care. The cost attribute was not significant. Intervention patients were willing to accept the NHS annual cost of €877 for their preferred scenario. The annual net benefit per patient is €788.20 and represents the monetary value of patients' welfare surplus for this model. Conclusions: This study is the first conducted in Portugal alongside a pharmacy collaborative trial, incorporating DCE into CBA. The findings can be used to guide the design of pharmacy collaborative interventions with primary care with the potential for reimbursement for uncontrolled or at-risk chronic disease patients informed by patient preferences. Future DCE studies conducted in community pharmacy may provide additional contributions.
- Improving health outcomes through treatment sequencing optimization in multiple myeloma: a simulation model in transplant‐ineligible patientsPublication . Geraldes, C.; Neves, M.; Bergantim, R.; Silva, Catarina; Leal da Costa, F.Objectives: Patients with multiple myeloma often require multiple treatment lines. The order in which treatments are sequenced has impact on clinical outcomes. This study aimed to estimate progression-free survival (PFS) and overall survival (OS) with common treatment sequences used in Portugal and the incremental benefit of an optimal sequence in transplant-ineligible patients with multiple myeloma. Methods: A state-transition sequential model with a five-health state conceptual structure was developed to simulate and compare survival outcomes between treatment sequences up to four lines of treatments. Data sources included randomized clinical trials and indirect treatment comparisons. A panel of Portuguese hematologists listed four most common treatment sequences and optimal sequence of choice in transplant-ineligible patients. Results: Our simulation estimated an OS between 6.1 and 7.8 years using the most common sequences, with VMP + DRd + Pd + Kd as the most effective (7.8 years). Optimal sequence of choice (DRd + PVd + Kd + Vd) achieved OS of 9.8 years and may extend OS in 2.0-3.7 years vs. most common sequences (26%-61% increase). This benefit was mostly explained by extended PFS in the first line of treatment. Conclusion: Model results demonstrate that choosing the most effective treatment upfront is crucial in delaying disease progression thus yielding better survival outcomes in transplant-ineligible patients. There was a clear survival benefit in using daratumumab-based regimens in first line. This modelling exercise highlights the need to raise awareness around the impact of sequencing strategies to improve patient's outcomes.
- Hyaluronic acid-based gels for oral application: comparison of in vitro effects on gingival cells and bacteriaPublication . Marques, Ana Filipa Silva; Silva, Neusa; Brito da Cruz, Mariana; Marques, Joana; Mata, AntónioPurpose: This study aimed to evaluate the cytotoxic effects of different topical hyaluronic acid-based gels on human gingival fibroblasts and oral bacteria. Methods: Four different hyaluronate gels - Bexident® Aftas (BA), GUM® AftaClear (AfC), Gengigel®(G), Aloclair® Plus (AlC) and a chlorhexidine gel - Bexident®Gums(BG) were selected. Human gingival fibroblasts (HGF) were seeded in 48-well plates with different gel/culture medium concentrations (v/v%) and cell viability was evaluated at 1 and 3 days of culture. Cell morphology was assessed, and alterations graded according to ISO 10993-5:2009(E). Streptococcus oralis CECT 907T colony was, seed on 48-well plate or spread onto the blood agar plates and exposed to the different gel's concentration. The optical density (OD) was assessed, and the diameter of the inhibition zone was measured (mm). Results: BA and G elicited reduced HGF cytotoxicity, followed by AfC. AlC and BG were cytotoxic at concentrations up to 3% for all exposure times. PCM images of HGF showed moderate-to-severe alterations for AlC and BG and slight to mild changes, for BA, AfC and G. The highest antibacterial activity against S.oralis was observed on AlC and AfC, and no antibacterial activity was observed for BA and G. Inhibitory effect in sessile colonies was only observed in AlC and BG. Conclusions: AlC demonstrated superior antibacterial activities against S.oralis but a higher cytotoxic potential in HGF. BA and G presented the lowest cytotoxicity with little to no antibacterial effect. AfC demonstrated bacteriostatic effects and low cytotoxicity on HGF.
- Biomimetic implant surfaces and their role in biological integration: a concise reviewPublication . Brito da Cruz, Mariana; Silva, Neusa; Marques, Joana; Mata, António; Silva, Felipe Samuel; Caramês, JoãoBackground: The increased use of dental implants in oral rehabilitation has been followed by the development of new biomaterials as well as improvements in the performance of biomaterials already in use. This triggers the need for appropriate analytical approaches to assess the biological and, ultimately, clinical benefits of these approaches. Aims: To address the role of physical, chemical, mechanical, and biological characteristics in order to determine the critical parameters to improve biological responses and the long-term effectiveness of dental implant surfaces. Data sources and methods: Web of Science, MEDLINE and Lilacs databases were searched for the last 30 years in English, Spanish and Portuguese idioms. Results: Chemical composition, wettability, roughness, and topography of dental implant surfaces have all been linked to biological regulation in cell interactions, osseointegration, bone tissue and peri-implant mucosa preservation. Conclusion: Techniques involving subtractive and additive methods, especially those involving laser treatment or embedding of bioactive nanoparticles, have demonstrated promising results. However, the literature is heterogeneous regarding study design and methodology, which limits comparisons between studies and the definition of the critical determinants of optimal cell response.
- Real-world effectiveness in hypertension and hyperlipidemia collaborative management between pharmacies and primary care in Portugal: a multicenter pragmatic controlled trial (USFarmácia®)Publication . Costa, Suzete; Biscaia, José Luís; Horta, Maria Rute; Romano, Sónia; Guerreiro, José; Heudtlass, Peter; Cary, Maria; Romão, Mariana; Teixeira Rodrigues, António; Miranda, Ana; Martins, Ana Paula; Bento, Ana Sofia; Pereira, João; Mateus, Céu; Helling, Dennis K.There is evidence of the efficacy of collaborative health interventions with pharmacies and primary care providers but little of its real-world effectiveness. We aimed to assess the effectiveness and discuss the design and challenges of hypertension and hyperlipidemia management between pharmacies and primary care providers using real-world data exchange between providers and experimental bundled payment. This was a pragmatic, quasi-experimental controlled trial. We collected patient-level data from primary care prescription claims and Electronic Medical Record databases, a pharmacy claims database, and patient telephone surveys at several time points. The primary outcomes were changes in blood pressure and total cholesterol. We used matched controls with difference-in-differences estimators in a Generalized Linear Model (GLM) and controlled interrupted time series (CITS). We collected additional data for economic and qualitative studies. A total of 6 Primary Care Units, 20 pharmacies, and 203 patients entered the study. We were not able to observe significant differences in the effect of intervention vs. control. We experienced challenges that required creative strategies. This real-world trial was not able to show effectiveness, likely due to limitations in the primary care technology which affected the sample size. It offers, however, valuable lessons on methods, strategies, and data sources, paving the way for more real-world effectiveness trials to advance value-based healthcare.
- Unwarranted clinical practice variation and resource overutilization in medical care: the example of transfusion practices in elderly hospital patientsPublication . Carneiro, António VazClinical practice variation refers to the differences in healthcare practices and treatment decisions among healthcare providers, for patients with similar clinical conditions. These variations can occur within and across regions, healthcare systems, and individual practitioners, as well as different contexts of care. Variation can be classified in warranted or unwarranted. Unwarranted variation is defined as a variation in clinical practice or outcomes which cannot be accounted for by patient baseline risk, preferences, economic constraints or access to technology. The presence of unwarranted clinical practice variation (UCPV) poses challenges in achieving consistent, high-quality care and can lead to disparities in patient outcomes. UCVP encompasses deviations from established clinical guidelines or evidence-based practices, and these variations can manifest in numerous ways, such as differences in diagnostic approaches, treatment modalities, medication choices, surgical procedures, and care pathways.
- Human gingival fibroblast and osteoblast behavior on groove-milled zirconia implant surfacesPublication . Brito da Cruz, Mariana; Marques, Joana; Silva, Neusa; Madeira, Sara; Carvalho, Óscar; Silva, Filipe Samuel; Caramês, João; Mata, AntónioTwo type of cells representing periodontal hard tissues (osteoblasts) and soft tissues (fibroblasts) were evaluated in response to microgroove-milled zirconia surfaces. A total of 90 zirconia discs were randomly assigned to four width-standardized milling microgroove-textured groups and a control group without grooves (UT). The sandblast and acid-etch protocol were applied to all samples. Both cell lines were cultured on zirconia discs from 1 day up to 14 days. Cell morphology and adhesion were evaluated after 1 day of culturing. Cell viability and proliferation of the cells were measured. Alkaline phosphatase activity, collagen I, osteopontin, interleukin 1β and interleukin 8 secretions were assessed at predefined times. The results obtained were presented in the form of bar graphs as means and standard deviations. Multi comparisons between groups were evaluated using two-away ANOVA or Mann-Whitney tests, and a p-value < 0.05 was established. Group comparisons with regard to cell viability, proliferation and secretion of collagen I, interleukin-1β and interleukin 8 revealed no statistically significant differences. The alkaline phosphatase activity and osteopontin secretion were significantly higher in the group with a large groove compared to the small one and the control group. Nevertheless, the viability of gingival and bone cells did not appear to be affected by the milled microgroove texture compared to the conventional sandblasted and acid-etched texture, but they seem to influence osteoblasts' cellular differentiation.
- Histology-agnostic drugs: a paradigm shift: a narrative reviewPublication . Mansinho, André; Fernandes, Ricardo M.; Carneiro, António VazCancer diagnosis and therapeutics have been traditionally based on pathologic classification at the organ of origin. The availability of an unprecedented amount of clinical and biologic data provides a unique window of opportunity for the development of new drugs. What was once treated as a homogeneous disease with a one-size-fits-all approach was shown to be a rather heterogeneous condition, with multiple targetable mutations that can vary during the course of the disease. Clinical trial designs have had to adapt to the exponential growth of targetable mechanisms and new agents, with ensuing challenges that are closer to those experienced with rare diseases and orphan medicines. To face these problems, precision/enrichment and other novel trial designs have been developed, and the concept of histology-agnostic targeted therapeutic agents has emerged. Patients are selected for a specific agent based on specific genomic or molecular alterations, with the same compound used to potentially treat a multiplicity of cancers, granted that the actionable driver alteration is present. There are currently approved drugs for such indications, but this approach has raised issues on multiple levels. This review aims to address the challenges of this new concept and provide insights into possible solutions and frameworks on how to tackle them.
- Cost-effectiveness and cost-utility of hypertension and hyperlipidemia collaborative management between pharmacies and primary care in portugal alongside a trial compared with usual care (USFarmácia®)Publication . Costa, Suzete; Guerreiro, José; Teixeira, Inês; Helling, Dennis K.; Pereira, João; Mateus, CéuBackground: There is little experience in the economic evaluation of pharmacy/primary care collaborative health interventions using interprofessional technology-driven communication under real-world conditions. This study aimed to conduct cost-effectiveness and cost-utility analyses of a collaborative care intervention in hypertension and hyperlipidemia management between pharmacies and primary care versus usual (fragmented) care alongside a trial. Methods: An economic evaluation was conducted alongside a 6-month pragmatic quasi-experimental controlled trial. Data sources included primary care clinical software; pharmacy dispensing software; patient telephone surveys; and published literature. The target population was adult patients on hypertension and/or lipid-lowering medication. The perspective was societal. We collected patient-level data on resource use to estimate trial costs. Effect outcomes included blood pressure (BP) and quality-adjusted life years (QALYs). Bootstrapping was used to estimate uncertainty around the incremental cost-effectiveness and cost-utility ratios. Cost-effectiveness planes and acceptability curves were estimated. Results: The intervention was not shown to have reasonable levels of cost-effectiveness or cost-utility when compared to usual care as denoted by the levels of uncertainty expressed in wide confidence intervals. The probability of the intervention being cost-effective is 28% at the threshold of €20,000 per QALY gained and 57% at the threshold of €500 per mmHg systolic BP decrease. Conclusion: Considering the limitations of the trial which affected effectiveness and economic outcomes, our results are not generalizable for community pharmacy and primary care in Portugal. This research offers, however, valuable lessons on methods and strategies that can be used in future economic evaluations of collaborative public health interventions with the potential for reimbursement.
- Ten year anniversary of choosing wisely campaignsPublication . Kherad, Omar; Carneiro, António VazCW campaigns have indeed spread around the world and several medical societies in Europe launched quality driven anti-waste campaigns such as, Smartermedicine in Switzerland, Slow Medicine in Italy, SMART Medicine Initiative in Israel, “Mais Nem Sempre é Melhor” in Portugal and Choosing Wisely in UK, France, Belgium, Romania, Russian Federation and Poland. The campaigns are centered on conversations between clinicians and patients about unnecessary tests, treatments, and procedures that account for up to 20% of all medical costs. These societies published “top-five lists” of low-value medical interventions that should be avoided.
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