29 results on '"Caridad Pontes"'
Search Results
2. Heterogeneity in pharmacological treatment and outcomes in Crohn’s disease patients in Catalonia: a population-based observational study
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Eduard Brunet, Emili Vela, Luigi Melcarne, Laura-Patricia Llovet, Anna Puy, Montserrat Clèries, Caridad Pontes, Pilar García-Iglesias, Albert Villòria, Gilaad G. Kaplan, and Xavier Calvet
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Treatment Outcome ,Crohn Disease ,Adrenal Cortex Hormones ,Spain ,Humans ,General Medicine ,Immunosuppressive Agents - Abstract
Heterogeneity in the treatment of a disease is a marker of suboptimal quality of care. The aim of this study is to evaluate the heterogeneity in the treatment used and the outcomes for Crohn's disease (CD) in Catalonia.All patients with CD included in the Catalan Health Surveillance System (data on more than seven million individuals from 2011 to 2017) were identified. The different Catalonian health areas were grouped into 19 district groups (DG). Treatments used rates (systemic corticosteroids, non-biological and biological immunosuppressant) and outcomes rates (hospitalization and surgery) were calculated.The use of systemic corticosteroids presented a decreasing trend over the study period, with an average rate of use in the different territories between 11% and 17%. The use of non-biological immunosuppressant treatment has remained stable, with an average rate of use ranging from 22% to 40% per year depending on the DG. The use of biological immunosuppressant treatment increased with an average rate of use in the different territories ranging from 10 to 23%.Hospitalizations for any reason showed an increasing trend between 2011 and 2017 with an average rate of between 23% and 32% per year depending on the area. Hospitalizations for CD presented a decreasing trend, with an average rate of between 5% and 11% per year. Surgical treatment remained stable over time, rates per year were between 0.5% and 2%.A remarkable geographical heterogeneity in the use of different treatments and in outcomes of CD was observed between different geographical areas of Catalonia. KEY MESSAGEThere is a notable geographical heterogeneity in the administration of biological and immunosuppressive treatments to Crohn's disease patients in Catalonia.There is also a geographical heterogeneity in their rates of hospitalization and surgical intervention.
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- 2022
3. Utilisation trend of long-acting insulin analogues including biosimilars across Europe: findings and implications
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Mikael Hoffmann, Stuart McTaggart, Vanda Marković-Peković, Irene Langner, Skule Ingeberg, Iva Selke Krulichová, Carol Holmes, Juraj Slabý, Brian Godman, Biljana Tubić, Svens Henkuzens, Corinne Zara, Jakub Rutkowski, Jurij Fürst, András Inotai, Stephen Campbell, Konstantin Tachkov, Sean MacBride-Stewart, Ileana Mardare, Mihajlo Jakovljevic, Kristina Garuolienė, Marta Turu Pedrola, Øyvind Melien, Gisbert Selke, Magdalene Wladysiuk, Björn Wettermark, Amanj Kurdi, Arianit Jakupi, Caridad Pontes, Vasileios Kourafalos, Manfred Hinteregger, Eleonora Allocati, Radka Nejezchlebova, Guenka Petrova, Francis Kalemeera, Rita Banzi, András Harsányi, Patricia Vella Bonanno, Ott Laius, Robert Sauermann, Alice Pisana, Jolanta Gulbinovič, Anna Nachtnebel, and Iris Hoxha
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Hälso- och sjukvårdsorganisation, hälsopolitik och hälsoekonomi ,Article Subject ,Long acting insulin ,Cost-Benefit Analysis ,Health authority ,medicine.medical_treatment ,Pharmaceutical policy ,Insulin Glargine ,Genetics and Molecular Biology ,General Biochemistry, Genetics and Molecular Biology ,Patient Education as Topic ,Systematic reviews (Medical research) ,Diabetes Mellitus ,medicine ,Humans ,Hypoglycemic Agents ,Poor glycaemic control ,Drugs -- Costs ,Biosimilar Pharmaceuticals ,General Immunology and Microbiology ,Public economics ,Insulin glargine ,Insulin ,Stakeholder ,Biosimilar ,Health Care Service and Management, Health Policy and Services and Health Economy ,General Medicine ,Europe ,Insulin, Long-Acting ,Eastern european ,Diabetes -- Patients -- Europe ,General Biochemistry ,Medicine ,Business ,Research Article ,medicine.drug - Abstract
Background. Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. Results. Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups. Conclusions. There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed., peer-reviewed
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- 2022
4. Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications
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Ruaraidh Hill, Christian Hierländer, Carolina Zampirolli Dias, Tomasz Bochenek, Ott Laius, Lars L. Gustafsson, Tracey-Lea Laba, Arianit Jakupi, Øyvind Melien, Wija Oortwijn, Luka Voncina, Durhane Wong-Rieger, Caridad Pontes, Jf Hans Piepenbrink, Magdalene Wladysiuk, Guenka Petrova, Patricia Vella Bonanno, Corinne Zara, Robert Sauermann, Steven Simoens, Olayinka O Ogunleye, Amanj Kurdi, Wouter Hamelinck, Wania Cristina Silva, Dzintars Gotham, Seung Jin Bae, Johanna C Meyer, Roberta Joppi, Janet Wale, Admir Malaj, John Yfantopoulos, Gisbert Selke, Angela Timoney, Brian Godman, Vincent de Valk, Andrew Hill, Merce Obach Cortadellas, D Tomek, Hye-Young Kwon, Irene Langner, Jurij Fürst, Iva Selke Krulichová, Antony P. Martin, Jolanta Gulbinovič, Iris Hoxha, Eleonora Allocati, Stuart McTaggart, Ieva Greiciute-Kuprijanov, Vanda Marković-Peković, Ileana Mardare, Godman, Brian, Hill, Andrew, Simoens, Steven, Selke, Gisbert, Laba, Tracey-Lea, and Hill, Ruaraidh
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Transparency (market) ,Amortization (business) ,Medical care -- Cost control ,Alternative pricing approaches ,cancer medicines ,europe ,managed entry agreements ,minimum effectiveness criteria ,multicriteria decision analyses ,payers ,tiered pricing approaches ,transparent pricing approaches ,0302 clinical medicine ,Neoplasms ,Health care ,Pharmacology (medical) ,Confidentiality ,030212 general & internal medicine ,Pharmacology & Pharmacy ,Reimbursement ,health care economics and organizations ,Public economics ,030503 health policy & services ,Health Policy ,General Medicine ,Europe ,Models, Economic ,Value (economics) ,Health Policy & Services ,Costs and Cost Analysis ,0305 other medical science ,Life Sciences & Biomedicine ,Scrutiny ,Cancer -- Treatment -- Europe ,Antineoplastic Agents ,Medical care -- Cost control -- Europe ,Drug Costs ,Patents as Topic ,Reimbursement Mechanisms ,03 medical and health sciences ,Drug Development ,Humans ,Drugs -- Law and legislation -- Decision making ,1115 Pharmacology and Pharmaceutical Sciences, 1117 Public Health and Health Services, 1402 Applied Economics ,Science & Technology ,business.industry ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Health Care Sciences & Services ,Sustainability ,Business ,RA ,Delivery of Health Care - Abstract
Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems. Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines. Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments., peer-reviewed
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- 2021
5. Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain)
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Montse Gasol, Noelia Paco, Laura Guarga, Josep Àngel Bosch, Caridad Pontes, and Mercè Obach
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Drug accessibility ,early access ,multicriteria decision analysis ,MCDA ,drug policy ,assessment ,pharmaceuticals ,Multicriteria decision analysis ,Early access ,Drug policy ,Pharmaceuticals ,General Medicine ,Malalties rares ,Assessment ,Accés als medicaments ,Rare diseases - Abstract
Early access to medicines allows the prescription of a medicine before it is available in the public formulary to patients with severe or rare diseases with high unmet needs who have no authorised therapeutic alternatives available. In this context, consistent decision making is difficult, and a systematic assessment procedure could be useful to tackle complex situations and guarantee the equity of medicines’ access. A multidisciplinary panel (MP) conducted four workshops to develop an early access framework based on a reflective multiple criteria decision analysis (MCDA). A set of 12 criteria was agreed: eight quantitative (severity of disease, urgency, efficacy, safety, internal and external validity, therapeutic benefit and plausibility) and four qualitative (therapeutic alternative, existence of precedents, management impact and costs). Quantitative criteria were weighted using a five-point scale. The relative importance of quantitative criteria had mean weights from 4.7 to 3.6, showing its relevance in the decisions. The framework was tested using two case studies, and reliability was assessed by re-test. The re-test revealed no statistical differences, indicating the consistency and replicability of the framework developed. MCDA may help to structure discussions for heterogeneous treatment requests, providing predictability and robustness in decision making involving sensitive and complex situations.
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- 2022
6. P604 Evaluation of management heterogeneity and complications of Crohn’s disease in Catalonia. A population quality care study
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Pilar García-Iglesias, Eduard Brunet, Xavier Calvet, Emili Vela, L Melcarne, Montserrat Cleries, V Albert, Caridad Pontes, and L. Llovet
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medicine.medical_specialty ,Crohn's disease ,education.field_of_study ,business.industry ,ADRENAL CORTICOSTEROIDS ,Population ,Gastroenterology ,Quality care ,General Medicine ,medicine.disease ,Inflammatory bowel disease ,medicine ,Quality of care ,Intensive care medicine ,business ,education - Abstract
Background Heterogeneity in the treatment of a disease is a marker of suboptimal quality of care. Recent studies suggest that there is a marked heterogeneity in the management of inflammatory bowel disease. The aim of this study is to evaluate the heterogeneity in the treatment used and the outcomes (rate of hospitalization and surgery) for Crohn’s disease (CD) in the different health areas of Catalonia. Methods All patients with CD included in the Catalan Health Surveillance System (CHSS) including data on more than 7 million individuals from 2011 to 2017 were identified using with the ICD-9-CM codes. The different Catalonian health areas were grouped into 19 groups according to the reference hospital (figure 1). Exposures to different treatments were retrieved from the electronic dispensation records. Data on hospitalizations and surgeries were also extracted from the CHSS according to ICD-9-CM codes. Treatment used rates (systemic corticosteroids, non-biological and biological immunosuppressant) and outcome rates (hospitalization and surgery) were calculated. Results The use of systemic corticosteroids presented a decreasing trend over the study period, with an average rate of use of the total number of patients in the different territories between 10% and 16% (figure 2). The use of non-biological immunosuppressant treatment has remained stable, with an average rate of use ranging from 20% to 40% (figure 3). On the other hand, the use of biological immunosuppressant treatment increased, with an average rate of use in the different territories ranging from 10 to 22% (figure 4). Hospitalizations for any reason showed an increasing trend between 2011–2017 with an average rate between 19% and 30% per year depending on the area. Contrarily, hospitalizations for CD presented a decreasing trend, with an average rate between 5% and 10% per year. Surgical treatment (both resections and ostomies) remained stable over time. Rates per year were between 1% and 2%. Conclusion In this population study we appreciated an important heterogeneity in the use of non-biological and biological immunosuppressant treatments, identifying use rates of almost the double in some of the areas. There is also a remarkable variability in the rate of hospitalizations for CD between certain areas of Catalan territory.
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- 2021
7. Time Trends of Crohn’s Disease in Catalonia from 2011 to 2017. Increasing Use of Biologics Correlates with a Reduced Need for Surgery
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Pilar García-Iglesias, Xavier Calvet, Caridad Pontes, L Melcarne, Eduard Brunet, Mercedes Vergara, Marta Gallach, Albert Villoria, Montserrat Cleries, Emili Vela, and Laura Patricia Llovet
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Drug ,Crohn’s disease ,medicine.medical_specialty ,Epidemiology ,media_common.quotation_subject ,Population ,lcsh:Medicine ,Disease ,Inflammatory bowel disease ,Article ,03 medical and health sciences ,0302 clinical medicine ,inflammatory bowel disease ,medicine ,030212 general & internal medicine ,education ,media_common ,education.field_of_study ,Crohn's disease ,business.industry ,Time trends ,lcsh:R ,General Medicine ,medicine.disease ,digestive system diseases ,Surgery ,Clinical trial ,030211 gastroenterology & hepatology ,epidemiology ,business - Abstract
Background and Aims: Data from clinical trials suggest that biological drugs may improve the outcomes in Crohn&rsquo, s disease (CD) by reducing the need for surgery or hospitalization. The aim of this study is to evaluate the time-trends of the use of biological drugs and other treatments for CD, and its relationship with outcomes in Catalonia. Materials and Methods: All patients with CD included in the Catalan Health Surveillance System (containing data on a population of more than 7.5 million) from 2011 to 2017 were identified. The exposures to different treatments for inflammatory bowel disease were retrieved from electronic invoicing records. Results: Between 2011 and 2017, the use of salicylates, corticosteroids and immunosuppressive treatment fell from 28.8% to 17.1%, 15.8% to 13.7%, and 32.9% to 29.6%, respectively (p <, 0.001). Biological treatment use rose from 15.0% to 18.7% (p <, 0.001). Ostomy rates per 1000 patients/year fell from 13.2 in 2011 to 9.8 in 2017 (p = 0.003), and surgical resection rates from 24.1 to 18.0 (p <, 0.001). The rate of CD-related hospitalizations per 1000 patients/year also fell, from 92.7 to 72.2 (p <, 0.001). Conclusions: Biological drug use rose from 15.0% to 18.7% between 2011 and 2017. During this period, we observed an improvement in the outcomes of CD patients.
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- 2020
8. Time to review authorisation and funding for new cancer medicines in Europe? Inferences from the case of Olaratumab
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Patricia Vella-Bonanno, Ileana Mardare, Caridad Pontes, Renata Curi Hauegen, Mercè Obach, Anna Nachtnebel, Stephen Campbell, Rickard E. Malmström, Tomasz Bochenek, Cristina Nadal, Jurij Fürst, Brian Godman, Antony P. Martin, Jolanta Gulbinovič, Marion Bennie, Tanja Mueller, Corinne Zara, Steven Simoens, Celia C. Rothe, Gisbert Selke, Josep Torrent-Farnell, Michael Ermisch, and Angela Timoney
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Adult ,Male ,Economics and Econometrics ,medicine.medical_specialty ,Antineoplastic Agents ,Health administration ,03 medical and health sciences ,0302 clinical medicine ,RA0421 ,Neoplasms ,Economic cost ,Agency (sociology) ,medicine ,Added value ,Humans ,030212 general & internal medicine ,Drug Approval ,Aged ,Aged, 80 and over ,Antibiotics, Antineoplastic ,Actuarial science ,Health economics ,030503 health policy & services ,Health Policy ,Public health ,Authorization ,Antibodies, Monoclonal ,General Medicine ,Middle Aged ,Europe ,Doxorubicin ,Female ,Business ,0305 other medical science ,Olaratumab ,medicine.drug - Abstract
The potential benefits of early patient access to new medicines in areas of high unmet medical need are recognised, but uncertainties concerning effectiveness, safety and added value when new medicines are authorised, and subsequently funded based on initial preliminary data only, have important implications. In 2016 olaratumab received accelerated conditional approval from both the European Medicines Agency and the US Food and Drug Administration for the treatment of soft-tissue sarcoma, based on the claims of a substantial reduction in the risk of death with an 11.8-month improvement in median overall survival in a phase II trial in combination with doxorubicin vs. doxorubicin alone. The failure to confirm these benefits in the post-authorisation pivotal trial has highlighted key concerns regarding early access and conditional approvals for new medicines. Concerns include potentially considerable clinical and economic costs, so that patients may have received suboptimal treatment and any money spent has foregone the opportunity to improve access to effective treatments. As a result, it seems reasonable to reconsider current marketing authorisation models and approaches. Potential pathways forward include closer collaboration between regulators, pharmaceutical companies and payers to enhance the generation of rapid and comparative confirmatory trials in a safe and fair manner, with minimal patient exposure as required to achieve robust evidence. Additionally, it may be time to review early access systems, and to explore new avenues regarding who should pay or part pay for new treatments whilst information is being collected as part of any obligations for conditional marketing authorisation. Greater co-operation between countries regarding the collection of data in routine clinical care, and further research on post-marketing data analysis and interpretation, may also contribute to improved appraisal and continued access to new innovative cancer treatments.
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- 2020
9. Randomized clinical trial to compare the efficacy to improve the quality of surgical field of hypotensive anesthesia with clonidine or dexmedetomidine during functional endoscopic sinus surgery
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Alda Cardesín, S López, Manuel Bernal-Sprekelsen, Roser Vives, A Izquierdo, M Fradera, Caridad Pontes, Yolanda Escamilla, and Laura Samara
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Male ,medicine.medical_specialty ,Operative Time ,Blood Loss, Surgical ,Hemodynamics ,Clonidine ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Nasal Polyps ,Randomized controlled trial ,law ,Heart rate ,Paranasal Sinuses ,medicine ,Adrenergic alpha-2 Receptor Agonists ,Humans ,Anesthesia ,Dexmedetomidine ,Sinusitis ,030223 otorhinolaryngology ,Rhinitis ,business.industry ,Endoscopy ,General Medicine ,Functional endoscopic sinus surgery ,Middle Aged ,Treatment Outcome ,Otorhinolaryngology ,030220 oncology & carcinogenesis ,Chronic Disease ,Female ,Neurosurgery ,business ,medicine.drug - Abstract
Intense bleeding of the surgical field is a potential factor influencing success of functional endoscopic sinus surgery (FESS). Hypotensive anesthesia with α2 intravenous agonists reduces intraoperative bleeding, but which is the best agent is unknown. The main objective of this trial was to compare the current standard adjuvant drug for hypotensive anesthesia, clonidine, with the recently available alternative dexmedetomidine. A randomized clinical trial compared the efficacy of clonidine and dexmedetomidine during FESS. Treatment was open label for the anesthesiologist and operating surgeon, but blind for an external evaluator who evaluated video-recorded surgeries. A Boezaart scale was assessed every 30 min during FESS until surgery completion. Main end-point was the proportion of patients with mean Boezaart scores > 2 (heavy bleeding) by external blinded evaluator. Secondary end-points included other bleeding parameters, surgery duration, hemodynamic measures and surgical complications. 94 patients were randomized. There were no significant differences in the proportion of patients with mean Boezaart scores > 2 in clonidine (42.6%) and dexmedetomidine (42.6%). Consistently, no differences were observed in secondary variables of bleeding, duration or complications. Small differences in mean heart rate were observed that might reflect different pharmacological profiles of the products, but are of uncertain clinical relevance. No significant differences were observed between clonidine and dexmedetomidine when used as anesthetic adjuvants in the reduction of surgical bleeding in FESS. A longer experience with clonidine and its lower costs suggest it may be a preferable option as an adjuvant for hypotensive anesthesia.
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- 2019
10. Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)
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Caridad Pontes, L. Guarga, X Badia, Manel Fontanet, Mercè Obach, Alba Prat, Josep Torrent, Atonio Vallano, [Guarga L] Àrea del Medicament, Servei Català de la Salut (CatSalut), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. Omakase Consulting S.L., Barcelona, Spain. [Badia X] Omakase Consulting S.L., Barcelona, Spain. [Obach M, Prat A, Vallano A, Torrent J, Fontanet M] Àrea del Medicament, Servei Català de la Salut (CatSalut), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. [Pontes C] Àrea del Medicament, Servei Català de la Salut (CatSalut), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain, Departament de Salut, and Universitat de Barcelona
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0301 basic medicine ,Process management ,Catalonia ,Orphan Drug Production ,Investigative Techniques::Drug Development::Drug Evaluation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Computer science ,Process (engineering) ,Cost-Benefit Analysis ,Medicaments orfes - Catalunya - Avaluació ,Decision Making ,lcsh:Medicine ,Context (language use) ,030105 genetics & heredity ,Catalan healthcare ,Decision Support Techniques ,Orphan drug ,03 medical and health sciences ,0302 clinical medicine ,Multi-criteria decision analysis ,Added value ,Humans ,Orphan drugs ,Pharmacology (medical) ,Technology, Industry, and Agriculture::Industry::Manufacturing Industry::Drug Industry::Orphan Drug Production [TECHNOLOGY, INDUSTRY, AND AGRICULTURE] ,Genetics (clinical) ,Public health ,Research ,lcsh:R ,Catalunya ,General Medicine ,Evidence-based medicine ,Multiple-criteria decision analysis ,Salut pública ,Test (assessment) ,Multiple criteria decision making ,Salut pública - Presa de decisions ,Presa de decisions multicriteri ,Transparency (graphic) ,técnicas de investigación::desarrollo de medicamentos::evaluación de medicamentos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,tecnología, industria y agricultura::industria::industria fabril::industria farmacéutica::producción de medicamentos huérfanos [TECNOLOGÍA, INDUSTRIA Y AGRICULTURA] ,Medicaments orfes ,030217 neurology & neurosurgery ,Decision-making - Abstract
Catalan healthcare; Decision-making; Multi-criteria decision analysis; Orphan drugs Sanitat catalana; Presa de decisions; Anàlisi de decisions multicriteri; Medicaments orfes Sanidad catalana; Toma de decisiones; Análisis de decisiones multicriteria; Medicamentos huérfanos BACKGROUND: Orphan medicines show some characteristics that hinder the evaluation of their clinical added value. The often low level of evidence available for orphan drugs, together with a high budget impact and an incremental cost-effectiveness ratio many times higher than drugs used for non-orphan diseases, represent challenges in their appraisal and effective access to clinical use. In order to explore how to handle these hurdles, the Catalan Health Service (CatSalut) began an initiative on a multidimensional assessment of drugs value during the appraisal process. Reflective multicriteria decision analysis (MCDA) using analytical methods was chosen, since it may help to standardise and contextualize all the relevant data related with the drug that could contribute to a decision. The aim of the study was to determine whether the implementation of reflective MCDA methodology could support the decision-making process about orphan medicines in the context of CatSalut. METHODS: The assessment and decision-making process for orphan drugs in the Programa d'Harmonització Farmacoterapeutica (PHF) of CatSalut was prioritized to test the implementation of the reflective MCDA both a qualitative and quantitatively. A staged approach was used with the following main steps: selection and structuration of quantitative criteria (Core Model) and qualitative criteria (Contextual Tool), framework scoring and assessment of three orphan drug case studies. This proof-of-concept would grant a continued refinement of the methodology and, if and when validated, its potential integration to other therapeutic areas of the PHF. RESULTS: The final framework was composed by 10 quantitative criteria (Core Model) and 4 qualitative criteria (Contextual Tool) according to the PHF goals being the most important criteria "disease severity", "unmet need", "comparative effectiveness" and "comparative safety /tolerability". The matrix developed for the case studies served as a guide for the selection of the essential information that the decision-makers were expected to include in a framework. The reflective discussion was considered the most relevant phase of the approach to support inputs for health decision-making processes reflecting both drug value and place in therapy. CONCLUSIONS: The study showed that reflective MCDA methodology could be implemented to complement the decision-making process in CatSalut, as an aid to determine the clinical added value for orphan medicines. MCDA provided transparency and a structured discussion during the committee meetings, thus increasing transparency and predictability of the relevant items supporting the agreements adopted on orphan drugs access.
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- 2019
11. Applicability and added value of novel methods to improve drug development in rare diseases
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Robin Ristl, Caridad Pontes, Stavros Nikolakopoulos, Aranzazu Sancho, Konstantinos Pateras, Roser Vives, Juan Manuel Fontanet, Ferran Torres, Martin Posch, Katrien Oude Rengerink, Stella Pesiou, Kit C.B. Roes, Marian Mitroiu, Spineli Loukia, Johanna H. van der Lee, Gerd K. Rosenkranz, Armin Koch, Susanne Urach, APH - Methodology, AGEM - Inborn errors of metabolism, General Paediatrics, and APH - Quality of Care
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Statistical methods ,Computer science ,lcsh:Medicine ,Context (language use) ,Machine learning ,computer.software_genre ,01 natural sciences ,Goal Attainment Scaling ,Orphan ,010104 statistics & probability ,03 medical and health sciences ,Rare Diseases ,Clinical trials ,0302 clinical medicine ,Drug Development ,Prior probability ,Added value ,Humans ,Pharmacology (medical) ,0101 mathematics ,Genetics (clinical) ,business.industry ,Research ,lcsh:R ,Small population ,Bayes Theorem ,Rare condition ,General Medicine ,Evidence-based medicine ,3. Good health ,Drug development ,Sequential analysis ,Sample size determination ,030220 oncology & carcinogenesis ,Artificial intelligence ,business ,computer - Abstract
Background The ASTERIX project developed a number of novel methods suited to study small populations. The objective of this exercise was to evaluate the applicability and added value of novel methods to improve drug development in small populations, using real world drug development programmes as reported in European Public Assessment Reports. Methods The applicability and added value of thirteen novel methods developed within ASTERIX were evaluated using data from 26 European Public Assessment Reports (EPARs) for orphan medicinal products, representative of rare medical conditions as predefined through six clusters. The novel methods included were ‘innovative trial designs’ (six methods), ‘level of evidence’ (one method), ‘study endpoints and statistical analysis’ (four methods), and ‘meta-analysis’ (two methods) and they were selected from the methods developed within ASTERIX based on their novelty; methods that discussed already available and applied strategies were not included for the purpose of this validation exercise. Pre-requisites for application in a study were systematized for each method, and for each main study in the selected EPARs it was assessed if all pre-requisites were met. This direct applicability using the actual study design was firstly assessed. Secondary, applicability and added value were explored allowing changes to study objectives and design, but without deviating from the context of the drug development plan. We evaluated whether differences in applicability and added value could be observed between the six predefined condition clusters. Results and discussion Direct applicability of novel methods appeared to be limited to specific selected cases. The applicability and added value of novel methods increased substantially when changes to the study setting within the context of drug development were allowed. In this setting, novel methods for extrapolation, sample size re-assessment, multi-armed trials, optimal sequential design for small sample sizes, Bayesian sample size re-estimation, dynamic borrowing through power priors and fall-back tests for co-primary endpoints showed most promise - applicable in more than 40% of evaluated EPARs in all clusters. Most of the novel methods were applicable to conditions in the cluster of chronic and progressive conditions, involving multiple systems/organs. Relatively fewer methods were applicable to acute conditions with single episodes. For the chronic clusters, Goal Attainment Scaling was found to be particularly applicable as opposed to other (non-chronic) clusters. Conclusion Novel methods as developed in ASTERIX can improve drug development programs. Achieving optimal added value of these novel methods often requires consideration of the entire drug development program, rather than reconsideration of methods for a specific trial. The novel methods tested were mostly applicable in chronic conditions, and acute conditions with recurrent episodes. Electronic supplementary material The online version of this article (10.1186/s13023-018-0925-0) contains supplementary material, which is available to authorized users.
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- 2018
12. Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
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Roser Vives, Katrien Oude Rengerink, Josep Torrent-Farnell, Armin Koch, Martin Posch, Caridad Pontes, Rosa Morros, Aranzazu Sancho, José Ríos, M Gómez-Valent, Kit C.B. Roes, Ferran Torres, Jorge Martinalbo, and Juan Manuel Fontanet
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medicine.medical_specialty ,Orphan Drug Production ,Pharmacology toxicology ,Decision Making ,lcsh:Medicine ,03 medical and health sciences ,Clinical trials as topic ,0302 clinical medicine ,Research design/methods ,Rare Diseases ,Drug approval ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Intensive care medicine ,Genetics (clinical) ,business.industry ,Research ,lcsh:R ,Authorization ,General Medicine ,Causality ,3. Good health ,Orphan drug production ,Rare diseases ,Clinical trial ,Europe ,030220 oncology & carcinogenesis ,Research design/standards ,Clinical trialsas topic ,business ,Recurrent acute episodes - Abstract
Background To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice. Methods A grouping of medical conditions with similar characteristics regarding the potential applicability of methods and designs was created using a consensus approach. The 125 dossiers for authorised OMP published between 1999 and 2014 on the EMA webpage were grouped accordingly and data was extracted from European Public Assessment Reports (EPARs) to assess the extent and robustness of the pivotal evidence supporting regulatory decisions. Results 88% (110/125) of OMP authorizations were based on clinical trials, with 35% (38/110) including replicated pivotal trials. The mean (SD) number of pivotal trials per indication was 1.4 (0.7), and the EPARs included a median of three additional non-pivotal supportive studies. 10% of OMPs (13/125) were authorised despite only negative pivotal trials. One-third of trials (53/159) did not include a control arm, one-third (50/159) did not use randomisation, half the trials (75/159) were open-label and 75% (119/159) used intermediate or surrogate variables as the main outcome. Chronic progressive conditions led by multiple system/organs, conditions with single acute episodes and progressive conditions led by one organ/system were the groups where the evidence deviated most from conventional standards. Conditions with recurrent acute episodes had the most robust datasets. The overall size of the exposed population at the time of authorisation of OMP − mean(SD) 190.5 (202.5) − was lower than that required for the qualification of clinically-relevant adverse reactions. Conclusions The regulatory evidence supporting OMP authorization showed substantial uncertainties, including weak protection against errors, substantial use of designs unsuited for conclusions on causality, use of intermediate variables, lack of a priorism and insufficient safety data to quantify risks of relevant magnitude. Grouping medical conditions based on clinical features and their methodological requirements may facilitate specific methodological and regulatory recommendations for the study of OMP to strengthen the evidence base. Electronic supplementary material The online version of this article (10.1186/s13023-018-0926-z) contains supplementary material, which is available to authorized users.
- Published
- 2018
13. SEFC 2016. Oral Communications
- Author
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Caridad Pontes, Ana Aldea-Perona, and Ferran Torres
- Subjects
Pharmacology ,General Medicine ,Toxicology - Published
- 2016
14. SEFC 2016. Posters
- Author
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Caridad Pontes and Ferran Torres
- Subjects
Pharmacology ,General Medicine ,Toxicology - Published
- 2016
15. P743 Time trends of Crohn’s disease in Catalonia from 2011 to 2017. Increasing use of biologics correlates with a reduced need for surgery. A population-based study in Catalonia
- Author
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Lyndon V. Hernandez, L E Frisancho, Pilar García-Iglesias, Emili Vela, P Pedregal, A Soria, Eduard Brunet, G Grau, Montserrat Cleries, L Melcarne, V Jordi, Caridad Pontes, Xavier Calvet, Mercedes Vergara, Albert Villoria, B. Garcia-Sague, and Marta Gallach
- Subjects
Population based study ,Crohn's disease ,Pediatrics ,medicine.medical_specialty ,business.industry ,Time trends ,Gastroenterology ,Medicine ,General Medicine ,business ,medicine.disease - Abstract
Background Data from clinical trials suggest that biological drugs may improve the outcomes in Crohn’s disease (CD) by reducing the need for surgery or hospitalisation. However, data on the trends in biological drug use and outcomes in CD patients are scarce. The aim of this study is to evaluate the time-trends of the use of biological drugs and other treatments for CD, and its relationship with outcomes such as surgery and hospitalisation in Catalonia. Methods All patients with CD included in the Catalan Health Surveillance System (containing data on a population of more than 7.5 million) from 2011 to 2017 were identified. The exposures to different treatments for inflammatory bowel disease were retrieved from electronic invoicing records. Time trends for surgery and hospitalisation were described and tested for correlation with treatment using the statistical package R, version 3.4.3. Results Between 2011 and 2017, the use of salicylates, corticosteroids and immunosuppressive treatment fell from 28.8% to 17.1%, 15.8% to 13.7%, and 32.9% to 29.6%, respectively. Biological treatment use rose from 15.0% to 18.7%. Adalimumab was the most frequently prescribed biologic (1604 patients; 52% of all biologics in 2017). Ostomy rates per 1000 patients/year fell from 13.2 in 2011 to 9.8 in 2017, and surgical resection rates from 24.1 to 18.0. The rate of CD-related hospitalisations per 1000 patients/year also fell, from 92.7 to 72.2. Conclusion Biological drug use rose from 15.0% to 18.7% between 2011 and 2017. During the same period, we observed an improvement in the outcomes of CD patients.
- Published
- 2020
16. Prevalence, incidence and mortality of inflammatory bowel disease in Catalonia. A population-based analysis
- Author
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Montserrat Cleries, Emili Vela, L Melcarne, Caridad Pontes, Cristina Roig-Ramos, Eduard Brunet, Xavier Calvet, and Albert Villoria
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Population based ,digestive system ,Inflammatory bowel disease ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Age Distribution ,Crohn Disease ,Internal medicine ,Epidemiology ,medicine ,Prevalence ,Humans ,Registries ,Mortality ,Sex Distribution ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Incidence (epidemiology) ,Incidence ,Inflammatory Bowel Diseases ,General Medicine ,Middle Aged ,medicine.disease ,digestive system diseases ,Prevalence incidence ,Spain ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Colitis, Ulcerative ,Female ,business - Abstract
Introduction: Few recent data on the epidemiology of inflammatory bowel disease (IBD) are available, especially in Southern Europe. Aim: To evaluate the prevalence, incidence and mortality of IBD in Catalonia during the period 2011–2016. Material and methods: Data on the prevalence, incidence and mortality of IBD were obtained from the Catalan Health Surveillance System (CHSS). Crude incidence and prevalence rates were calculated for all the Catalan population. Trends in age-sex-adjusted rates were also estimated, and logistic regression was used to calculate the adjusted mortality odds ratio (OR). Data for Crohn’s disease (CD) and ulcerative colitis (UC) were analyzed separately. Results: The prevalence per 100,000 inhabitants in 2016 was 353.9 for UC and 191.4 for CD. The total number of IBD patients rose from 29543 in 2011 to 40614 in 2016. IBD was associated with significantly elevated adjusted mortality ratios: 1.28 (95% CI: 1.6–1.4) for UC and 1.85 (95% CI: 1.62–2.12) for CD. Conclusions: IBD prevalence is very high and is increasing rapidly in Catalonia. Both CD and UC are associated with significantly higher mortality rates.Key messageCrohn disease and ulcerative colitis present a small but significant increase in mortality compared to non-inflammatory bowel disease.The prevalence of inflammatory bowel disease is increasing rapidly in Catalonia.Data on prevalence and incidence suggest that the number of patients may double in approximately 10 years. Crohn disease and ulcerative colitis present a small but significant increase in mortality compared to non-inflammatory bowel disease. The prevalence of inflammatory bowel disease is increasing rapidly in Catalonia. Data on prevalence and incidence suggest that the number of patients may double in approximately 10 years.
- Published
- 2018
17. Rare disease registries: potential applications towards impact on development of new drug treatments
- Author
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Roser Vives, Marijke C. Jansen-van der Weide, C. M. W. Gaasterland, Kit C.B. Roes, Eric Vermeulen, Arantxa Sancho, Johanna H. van der Lee, Stavros Nikolakopoulos, Caridad Pontes, Graduate School, AGEM - Endocrinology, metabolism and nutrition, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, AGEM - Digestive immunity, APH - Methodology, AGEM - Inborn errors of metabolism, and General Paediatrics
- Subjects
Registry ,Computer science ,media_common.quotation_subject ,lcsh:Medicine ,Drug development ,Disease ,law.invention ,03 medical and health sciences ,Rare Diseases ,0302 clinical medicine ,Randomized controlled trial ,law ,Humans ,Genetics(clinical) ,Pharmacology (medical) ,Quality (business) ,Registries ,030212 general & internal medicine ,Genetics (clinical) ,Randomized Controlled Trials as Topic ,media_common ,Clinical Trials as Topic ,Data collection ,Research ,Clinical study design ,lcsh:R ,General Medicine ,Checklist ,3. Good health ,Clinical trial ,Risk analysis (engineering) ,Research Design ,Rare disease ,030217 neurology & neurosurgery - Abstract
Background: Low prevalence, lack of knowledge about the disease course, and phenotype heterogeneity hamper the development of drugs for rare diseases. Rare disease registries (RDRs) can be helpful by playing a role in understanding the course of the disease, and providing information necessary for clinical trial design, if designed and maintained properly. We describe the potential applications of a RDR and what type of information should be incorporated to support the design of clinical trials in the process of drug development, based on a broad inventory of registry experience. We evaluated two existing RDRs in more detail to check the completeness of these RDRs for trial design.Results: Before and during the application for regulatory approval a RDR can improve the efficiency and quality in clinical trial design by informing the sample size calculation and expected disease course. In exceptional circumstances information from RDRs has been used as historical controls for a one-armed clinical trial, and high quality RDRs may be used for registry-based randomized controlled trials. In the post marketing phase of (conditional) drug approval a disease-specific RDR is likely to provide more relevant information than a product-specific registry.Conclusions: A RDR can be very helpful to improve the efficiency and quality of clinical trial design in several ways. To enable the applicability and optimal use of a RDR longitudinal data collection is indispensable, and specific data collection, prepared for repeated measurement, is needed. The developed checklist can help to define the appropriate variables to include. Attention should be paid to the inclusion of patient-relevant outcome measures in the RDR from the start. More research and experience is needed on the possibilities and limitations of combining RDR information with clinical trial data to maximize the availability of relevant evidence for regulatory decisions in rare diseases.
- Published
- 2018
18. Appropriate antibiotic prescribing among final-year medical students in Europe
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Silvia Benemei, David J. Brinkman, Paraskevi Papaioannidou, Emilio J. Sanz, Aleksandar Rašković, Ralf Regenthal, Yves M. Pers, Emília C. Monteiro, Michiel A. van Agtmael, Kurt Wilson, Tim van der Voort, Bernard Chamontin, Thierry Christiaens, Ylva Böttiger, Romaldas Mačiulaitis, Toomas Marandi, Caridad Pontes, Jelle Tichelaar, Robert Likić, Anesthesiology, Internal medicine, AII - Infectious diseases, Amsterdam Gastroenterology Endocrinology Metabolism, Graduate School, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, CHU Toulouse [Toulouse], and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
- Subjects
0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Students, Medical ,Traditional learning ,Cross-sectional study ,[SDV]Life Sciences [q-bio] ,Teaching method ,030106 microbiology ,education ,MEDLINE ,Antibiotic prescribing ,Education ,03 medical and health sciences ,0302 clinical medicine ,Professional Competence ,Antibiotics ,Pneumonia ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Antibiotic use ,Practice Patterns, Physicians' ,business.industry ,Undergraduate education ,General Medicine ,Anti-Bacterial Agents ,Europe ,Infectious Diseases ,Cross-Sectional Studies ,Family medicine ,Medical training ,business - Abstract
International audience; Little is known about undergraduate education on antibiotic prescribing in Europe and even less about the antibiotic prescribing skills of nearly-graduated medical students. This study aimed to evaluate the antibiotic prescribing skills of final-year medical students across Europe and the education they received during medical training. In a cross-sectional study, final-year medical students from 17 medical schools in 15 European countries were asked to prescribe for two written case reports of infectious diseases (acute bronchitis and community-acquired pneumonia). The appropriateness of antimicrobial therapy was determined using a scoring form based on local guidelines. Teachers from each medical school were asked to complete a standardised questionnaire about the teaching and assessment of undergraduate education on antibiotic use. In total, 856 final-year medical students (95.6%) completed the assessment and 16 teachers (94.1%) completed the questionnaire. Overall, 52.7% (range 26-83%) of the 1.683 therapies prescribed were considered appropriate. The mean number of contact hours for undergraduate education on antimicrobials was 25.6 (range 2-90). Differences in education styles were found to have a significant impact on students' performance, with a problem-based learning style being associated with more appropriate antimicrobial prescribing than a traditional learning style (46.0% vs. 22.9%; P < 0.01). Although there are differences between medical schools, final-year medical students in Europe lack prescribing skills for two common infectious diseases, possibly because of inadequate undergraduate education on antibiotic use and general prescribing. To improve students' skills, interactive teaching methods such as prescribing for simulated and real patients should be used.
- Published
- 2018
19. A Drug Utilization Study of Sacubitril/Valsartan in Catalonia
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Montse Gasol, Pilar López, Caridad Pontes, Pere Carbonell, Andrea Molina, and Montse Vicente
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Drug Utilization ,Heart Failure ,Male ,business.industry ,Aminobutyrates ,Biphenyl Compounds ,Tetrazoles ,General Medicine ,Middle Aged ,Biotechnology ,Angiotensin Receptor Antagonists ,Drug Combinations ,Spain ,Prevalence ,Medicine ,Humans ,Valsartan ,Female ,business ,Sacubitril, Valsartan ,Aged - Published
- 2018
20. SEFC 2014. Oral Communications
- Author
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Caridad Pontes and Ferran Torres
- Subjects
Pharmacology ,General Medicine ,Toxicology - Published
- 2014
21. SEFC 2014. Posters
- Author
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Caridad Pontes and José Ríos
- Subjects
Pharmacology ,General Medicine ,Toxicology - Published
- 2014
22. Cambios en la normativa europea de ensayos clínicos (ii): por una regulación proporcionada y adaptada al riesgo
- Author
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Joaquin Delgadillo Duarte, Caridad Pontes, Cristina Avendaño Sola, Lourdes Cabrera García, Francisco Javier Carné Cladellas, and Francisco Jose De Abajo Iglesias
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business.industry ,Medicine ,General Medicine ,business ,Humanities - Published
- 2012
23. Cambios en la normativa europea de ensayos clínicos (i): una oportunidad para mejorar los trámites de autorización
- Author
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Joaquin Delgadillo Duarte, Caridad Pontes, Cristina Avendaño Sola, Lourdes Cabrera García, and Francisco Javier Carné Cladellas
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business.industry ,Medicine ,General Medicine ,business ,Humanities - Published
- 2012
24. A randomised double blind clinical trial to compare surgical field bleeding during endoscopic sinus surgery with clonidine-based or remifentanil-based hypotensive anaesthesia
- Author
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Yolanda Escamilla, J. Marco, Manuel Bernal-Sprekelsen, Alda Cardesín, M. J. Escobar, R. Rosell, and Caridad Pontes
- Subjects
Male ,medicine.medical_specialty ,Remifentanil ,Blood Loss, Surgical ,Hemodynamics ,Clonidine ,law.invention ,Double blind ,Randomized controlled trial ,Double-Blind Method ,Piperidines ,law ,medicine ,Paranasal Sinus Diseases ,Humans ,Antihypertensive Agents ,medicine.diagnostic_test ,business.industry ,Endoscopy ,General Medicine ,Middle Aged ,Surgery ,Clinical trial ,Regimen ,Treatment Outcome ,Otorhinolaryngology ,Anesthesia ,Female ,business ,Anesthetics, Intravenous ,medicine.drug - Abstract
Background: Significant bleeding during functional endoscopic naso-sinusal surgery (FESS) impairs recognition of anatomical references and may negatively affect surgical outcome. Anaesthesia including clonidine as an adjuntive hypotensive agent may reduce intraoperative bleeding. Methods: A randomised comparison of clonidine-based vs remifentanil-based hypotensive anaesthetic regimen was conducted in patients undergoing FESS. The main assessment was the proportion of subjects with Boezaart scores of surgical field bleeding, as blindly assessed from video recordings by a third surgeon not involved in patient care. Results: A total of 47 subjects underwent FESS and were randomised to clonidine or remifentanil. A significantly lower proportion of patients in the clonidine arm had blindly-assessed Boezaart scores higher than 2, with significantly lower mean blind Boezaart scores at 60 minutes and at 120 minutes. Similar findings were reported by the operating surgeon, and when Wormald and VAS scores were used. Objective estimates of bleeding and the duration of surgery and anaesthesia did not differ between groups. Conclusion: The use of clonidine- based controlled hypotensive anaesthesia achieves lower surgical field bleeding during FESS.
- Published
- 2015
25. Recomendaciones metodológicas de las agencias reguladoras
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Gonzalo Calvo, Ferran Torres, and Caridad Pontes
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business.industry ,Medicine ,General Medicine ,business ,Humanities - Abstract
Las autoridades sanitarias, mediante las agencias de medicamentos, determinan la idoneidad de los nuevos tratamientos para su uso en la poblacion general en terminos de beneficio y riesgo, y regulan su comercializacion y condiciones de utilizacion segun criterios estrictos de calidad, seguridad y eficacia. Para aplicar el principio de transparencia, las agencias hacen publicos los requisitos que despues se exigiran, en forma de documentos guia, facilmente disponibles en internet. Todas estas guias incorporan de uno u otro modo unas recomendaciones basicas: a) metodologia adecuada al objetivo y especificada en detalle a priori; b) trazabilidad; c) comprobacion de la adecuacion de los metodos usados; d) justificacion de cualquier desviacion del plan inicial, y e) demostracion de la robustez de los resultados en distintos escenarios. Las directrices reguladoras difieren de otras referencias metodologicas en un enfasis sobre los aspectos practicos del diseno y la conduccion de los estudios, los principios metodologicos aceptables y los sistemas de control de calidad de la investigacion. Si bien estas exigencias pueden no ser de aplicacion estricta a algunos tipos de investigacion, las guias estan facilmente disponibles y son una buena referencia a considerar para la autoria, revision y edicion de ensayos clinicos. El objetivo de este articulo es revisar algunas de estas directrices que pueden ser de especial utilidad.
- Published
- 2005
26. Datos ausentes: orden de búsqueda y captura
- Author
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Caridad Pontes and Ferran Torres
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business.industry ,Medicine ,General Medicine ,business ,Humanities - Published
- 2013
27. Double-blind randomized dose-finding study in acute vulvovaginal candidosis. Comparison of flutrimazole site-release cream (1, 2 and 4%) with placebo site-release vaginal cream
- Author
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Caridad Pontes, E. Boncompte, Francisca Sanz, Margarita Garau, María‐Teresa Calvo, A. Gómez de la Cámara, Mònica Algueró, Gracia Sánchez-Alor, and Amalia del Palacio
- Subjects
Adult ,medicine.medical_specialty ,Antifungal Agents ,Adolescent ,Dermatology ,Placebo ,Gastroenterology ,Group B ,law.invention ,Vaginal disease ,Randomized controlled trial ,Double-Blind Method ,law ,Internal medicine ,medicine ,Humans ,Clotrimazole ,Candidiasis, Vulvovaginal ,Vaginitis ,Aged ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Surgery ,Regimen ,Infectious Diseases ,medicine.anatomical_structure ,Treatment Outcome ,Vagina ,Vaginal Creams, Foams, and Jellies ,Female ,business ,Flutrimazole ,medicine.drug - Abstract
A double-blind randomized comparative phase II study of flutrimazole site-release vaginal cream (1, 2 and 4%) with placebo site-release vaginal cream was undertaken in patients with acute vulvovaginal candidosis. Vaginitis was demonstrated by both positive findings on microscopic examination of vaginal smears and positive culture as well as by the presence of clinical signs and symptoms. The vaginal monodose treatment was inserted in the evening at bedtime using a vaginal applicator and, in addition, all four groups of patients received additional topical external cream for application to the vulva twice-daily for 7 days; the placebo group received a placebo cream and the active therapy groups all received a 2% flutrimazole cream. A total of 133 patients who were seen over a 10-month period were screened and randomized: five patients did not take the allocated medication, and four patients whose menstrual period began shortly after study entry were excluded from the study, leaving 124 patients who were randomly allocated to receive a monodose vaginal 1% cream (regimen A, 28 patients), a monodose vaginal 2% cream (regimen B, 32 patients), a monodose vaginal 4% cream (regimen C, 31 patients) or a monodose vaginal placebo cream (regimen D, 33 patients). At the assessment 9 days after the end of therapy the proportion of patients who were cured was 82% in group A, 87.4% in group B, 83.8% in group C and 63.5% in group D. Three patients (10.7%) in group A, four (12.5%) in group B, one (3.2%) in group C and 12 (36.36%) in group D did not respond to the treatment. One patient (3.5%) in group A, and two patients (6.4%) in group C terminated the treatment prematurely due to intolerance. There was a significant association between Candida glabrata and treatment failure (P < 0.04) and C. glabrata and carrier state (P = 0.01) in vagina (chi 2 test, P = 0.01) and vulvovagina (chi 2 test, P = 0.00001). At the assessment 4 weeks after the end of therapy the proportion of cured patients was 60.6% in group A, 78% in group B, 80.6% in group C and 48.4% in group D. Group D (placebo) versus group B (2%) and group C (4%) showed a significant difference (P = 0.01 and P = 0.007, respectively). Although there were no significant differences in clinical and mycological activity between the three active groups, group B (flutrimazole 2% site-release vaginal cream) was chosen for clinical use due to its tolerance profile. Seven patients (25%) in group A, three (9.3%) in group B, two (6.4%) in group C and five (15.1%) in group D relapsed 4 weeks after the end of therapy; the relapse rate was not significantly associated with positive culture results 9 days after treatment. There was a significant association between C. glabrata and the carrier state (P < 0.01). The overall ineffective treatment (includes failures at control 1, relapses at control 2 and premature terminations) was 39% in group A, 21.7% in group B, 16% in group C and 51.3% in group D. There was a significant difference in the overall ineffective treatment when C and D groups were compared with placebo (P = 0.01 and P = 0.003, respectively).
- Published
- 2000
28. Ultrasound assessment of psoriatic onychopathy: a cross-sectional study comparing psoriatic onychopathy with onychomycosis
- Author
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Fernando Gallardo, Gustavo Deza, Mireia Moreno, Joan Maymó, Caridad Pontes, Jesús Luelmo, Marta Ferran, Jordi Gratacós, and María Pilar Lisbona
- Subjects
Adult ,Male ,medicine.medical_specialty ,Cross-sectional study ,Nail ,Dermatology ,Psoriatic onychopathy ,030218 nuclear medicine & medical imaging ,Diagnosis, Differential ,ONYCHOPATHY ,Nail Diseases ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Power doppler ,0302 clinical medicine ,Predictive Value of Tests ,Onychomycosis ,Ultrasound ,lcsh:Dermatology ,Humans ,Psoriasis ,Medicine ,skin and connective tissue diseases ,NAIL DYSTROPHY ,integumentary system ,business.industry ,Ultrasonography, Doppler ,General Medicine ,lcsh:RL1-803 ,Middle Aged ,Nail plate ,Cross-Sectional Studies ,medicine.anatomical_structure ,Nails ,Nail (anatomy) ,Female ,Nail Changes ,business - Abstract
This cross-sectional study evaluated the usefulness of an ultrasound technique in assessment of nail changes in 35 patients with psoriatic onychopathy and 25 with nail dystrophy secondary to onychomycosis. All patients underwent 3 examinations: a complete clinical assessment; a nail ultrasound study; and fungal culture. Nails of patients with psoriatic onychopathy presented a thinner nail plate and nail bed, measured by ultrasound, than did those with onychomycosis. The percentage of patients with a power Doppler signal ?2 at nail bed was significantly higher in psoriatic onychopathy than in onychomycosis, and structural bone lesions were more frequent in psoriatic onychopathy than in onychomycosis. These results suggest that the presence of structural damage and high-power Doppler signal are the main ultrasound findings supporting a diagnosis of psoriatic onychopathy.
29. Registro de pacientes y tratamientos de medicamentos hospitalarios en Cataluna: 10 años de datos clínicos
- Author
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Maria Alba Prat Casanovas, Marta Roig Izquierdo, Caridad Pontes García, Maria Queralt Gorgas Torner, [Roig-Izquierdo M, Pontes-García M] Àrea del Medicament, Servei Català de la Salut, Barcelona, Spain. Unitat Docent Parc Taulí, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona (UAB), Sabadell, Spain. [Prat-Casanovas MA] Àrea del Medicament, Servei Català de la Salut, Barcelona, Spain. [Gorgas-Torner MQ] Servei de Farmàcia, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Unitat Docent Parc Taulí, Departament de Farmacologia, de Terapèutica i de Toxicologia, Universitat Autònoma de Barcelona (UAB), Sabadell, Spain, and Departament de Salut
- Subjects
Catalonia ,business.industry ,Environmental Health::Health::Sanitary Management::Sanitary Statistics [PUBLIC HEALTH] ,salud ambiental::salud::gestión sanitaria::estadísticas sanitarias [SALUD PÚBLICA] ,General Medicine ,Registres hospitalaris - Catalunya ,Farmàcies d'hospital ,Calidad, Acceso y Evaluación de la Atención de Salud::Calidad de la Atención de Salud::Mecanismos de Evaluación de la Atención de Salud::Recolección de Datos::Registros::Registros de Hospitales [ATENCIÓN DE SALUD] ,Administración de los Servicios de Salud::Organización y Administración::Administración Hospitalaria::Departamentos de Hospitales::Servicio de Farmacia en Hospital [ATENCIÓN DE SALUD] ,Cataluña ,Medicine ,Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Data Collection::Records::Hospital Records [HEALTH CARE] ,business ,Estadística mèdica ,Humanities ,Health Services Administration::Organization and Administration::Hospital Administration::Hospital Departments::Pharmacy Service, Hospital [HEALTH CARE] - Abstract
Registre de pacients; Medicaments hospitalaris; Dades clíniques Patient registration; Hospital medicines; Clinical data Registro de pacientes; Medicamentos hospitalarios; Datos clínicos Durante el año 2011 se diseñó el actual Registro de Pacientes y Tratamientos MHDA (RPT-MHDA), un único registro específico y centralizado para todos los hospitales del SISCAT, con el objetivo de recoger, de forma sistemática, información sobre utilización, efectividad y seguridad de los MHDA en condiciones de práctica clínica habitual, así como el grado de adherencia a los criterios definidos por el PHF.
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