4 results on '"Pol, R"'
Search Results
2. Cost-utility analysis of Palivizumab for Respiratory Syncytial Virus infection prophylaxis in preterm infants: update based on the clinical evidence in Spain.
- Author
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Sanchez-Luna, M., Burgos-Pol, R., Oyagüez, I., Figueras-Aloy, J., Sánchez-Solís, M., Martinón-Torres, F., and Carbonell-Estrany, X.
- Subjects
- *
PALIVIZUMAB , *RESPIRATORY syncytial virus infections , *PREMATURE infants , *QUALITY-adjusted life years , *RESPIRATORY syncytial virus , *PREVENTION , *THERAPEUTICS , *ANTIVIRAL agents , *COST effectiveness , *GESTATIONAL age , *INTENSIVE care units , *LONGITUDINAL method , *MEDICAL care costs , *DISEASE relapse - Abstract
Background: This study aimed at estimating the efficiency of palivizumab in the prevention of Respiratory Syncytial Virus (RSV) infection and its sequelae in preterm infants (32day 1-35day 0weeks of gestational age -wGA-) in Spain.Methods: A decision-tree model was developed to compare health benefits (Quality Adjusted Life Years-QALYs) and costs of palivizumab versus a non-prophylaxis strategy over 6 years. A hypothetical cohort of 1,000 preterm infants, 32day 1-35day 0 wGA (4.356 kg average weight) at the beginning of the prophylaxis (15 mg/kg of palivizumab; 3.88 average number of injections per RSV season) was analysed. The model considered the most recent evidence from Spanish observational and epidemiological studies on RSV infection: the FLIP II study provided hospital admission and Intensive Care Unit (ICU) admission rates; in-hospital mortality rate was drawn from an epidemiological study from 2004 to 2012; recurrent wheezing rates associated to RSV infection from SPRING study were adjusted by the evidence on the palivizumab effect from clinical trials. Quality of life baseline value, number of hospitalized infants and the presence of recurrent wheezing over time were granted to estimate QALYs. National Health Service and societal perspective (included also recurrent wheezing indirect cost) were analysed. Total costs (€, 2016) included pharmaceutical and administration costs, hospitalization costs and recurrent wheezing management annual costs. A discount rate of 3.0% was applied annually for both costs and health outcomes.Results: Over 6 years, the base case analysis showed that palivizumab was associated to an increase of 0.0731 QALYs compared to non-prophylaxis. Total costs were estimated in €2,110.71 (palivizumab) and €671.68 (non-prophylaxis) from the National Health System (NHS) perspective, resulting in an incremental cost utility ratio (ICUR) of €19,697.69/QALYs gained (prophylaxis vs non-prophylaxis). Results derived from the risk-factors population subgroups analysed were in line with the total population results. From the societal perspective, the incremental cost associated to palivizumab decreased to an €1,253.14 (ICUR = €17,153.16€/QALYs gained for palivizumab vs non-prophylaxis). One-way and probabilistic sensitivity analyses confirmed the robustness of the model.Conclusions: The prophylaxis with palivizumab is efficient for preventing from RSV infections in preterm infants 32day 1-35day 0 wGA in Spain. [ABSTRACT FROM AUTHOR]- Published
- 2017
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3. RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.
- Author
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Derman RJ, Bellad RB, Bellad MB, Bradford-Rogers J, Georgieff MK, Aghai ZH, Thind S, Auerbach M, Boelig R, Leiby BE, Short V, Yogeshkumar S, Charantimath US, Somannavar MS, Mallapur AA, Pol R, Ramadurg U, Sangavi R, Peerapur BV, Banu N, Patil PS, Patil AP, Roy S, Vastrad P, Wallace D, Shah H, and Goudar SS
- Subjects
- Female, Humans, Infant, Infant, Newborn, Pregnancy, Follow-Up Studies, Hemoglobins, Iron, Observational Studies as Topic, Prospective Studies, Randomized Controlled Trials as Topic, Child, Preschool, Anemia complications, Iron Deficiencies
- Abstract
Background: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes., Methods: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age., Discussion: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes., Trial Registration: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022., (© 2023. The Author(s).)
- Published
- 2023
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4. Evaluation of the correlation between oral infections and systemic complications in kidney transplant patients: a retrospective pilot study.
- Author
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Pol R, Camisassa D, Bezzi M, Savoldi L, Punzi F, Carossa M, and Ruggiero T
- Subjects
- Humans, Retrospective Studies, Pilot Projects, Italy, Kidney Transplantation adverse effects, Mouth Diseases etiology
- Abstract
Background: Data regarding the efficacy of the dental clearance required prior to kidney transplantation (KT) for preventing post-transplant complications is controversial. The aim of this retrospective study was to investigate a possible correlation between any untreated oral infectious foci and the onset of systemic complications in KT patients., Methods: Patients scheduled for regular check-ups during the post-transplant period were visited at the C.I.R. Dental School in Turin, Italy. Patients were asked to bring orthopantomography (OPT) acquired prior to transplantation to compare the possible presence of untreated infectious foci at the time of transplantation with the time of their post-transplant visit. Patients were then divided, according to the evaluation of the OPT obtained prior to the transplantation, into two groups according to their dental status prior to the transplant. "Group Infected" was comprised of patients with no dental clearance, and "Group Clear" included patients with dental clearance. The medical records were then retrospectively reviewed for the evaluation of any systemic complications that occurred after transplantation. The following medical complications were considered: fever, pneumonia, urinary tract infections, systemic infections, kidney rejection, and death. Complications were divided in two groups: early complications, which occurred within 100 days of transplantation, and late complications, which occurred more than 100 days after transplantation., Results: A total of 77 patients were enrolled in the study. Group Infected was composed of 19 subjects (25%), while Group Clear was composed of 58 patients (75%). In Group Infected, 13 (68%) patients developed complications within 100 days of transplantation, and 11 (58%) did so after 100 days. In Group Clear, 31 (53%) patients had complications within 100 days of the transplant, and 23 (40%) did after 100 days. Patients in Group Infected had a statistically significant increase in episodes of fever (p = 0.03), compared to Group Clear, with a higher relative risk (RR) of 3.66 in the first 100 days after transplantation., Conclusion: Within the limitations of the present retrospective pilot study, and based on the results, a correlation between the absence of dental clearance prior to KT and a higher RR of developing a fever within the first 100 days post transplantation was highlighted. The present results encourage doctors to continue research on the topic, which remains controversial. Further prospective studies are required to confirm the results of the present study., (© 2022. The Author(s).)
- Published
- 2022
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