4 results
PP140 Economic Evaluation Of Several Vaccination Strategies Against Rotavirus In Spain
- Inaki Imaz-Iglesia, Montserrat Carmona, Esther E. García-Carpintero, Alejandro Martínez-Portillo, Enrique Alcalde-Cabero, Lidia García-Pérez, Renata Linertová
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S85
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Introduction
The Spanish Ministry of Health asked us about the efficiency of extending the current rotavirus vaccination strategy to all newborns. The current strategy is to vaccinate only to high-risk newborns (premature and those qualified as high-risk by a pediatrician). The objective of this research was to compare three strategies: no-vaccination, vaccination of high-risk newborns and universal vaccination, considering the two vaccines available in Spain: RotaTeq® and Rotarix®.
MethodsA cost-utility analysis, based on a de novo Markov model, was carried out both from a societal and a healthcare system perspective. The model follows a cohort of newborns during their life-course. The cycle length is annual and a half-cycle correction was applied. A discount rate of 3 percent was applied in the base case both to costs and utilities. Most of the incidence, probabilities and costs data were Spanish. The Quality Adjusted Life Year (QALY) data were taken from international literature. We assumed a willingness to pay threshold of EUR 25,000 per QALY gained. We performed deterministic one-way sensitivity analysis.
ResultsCompared to no-vaccination, the high-risk vaccination strategy is cost-effective assuming the above- mentioned threshold only with Rotarix® from a societal perspective (RotaTeq® EUR 32,008 per QALY; Rotarix® EUR 23,368 per QALY). Universal vaccination is not cost-effective either compared to no-vaccination or compared to the high-risk vaccination strategy and with both perspectives. Vaccine prices and efficacy data are highly sensitive variables. We find that universal vaccination would be cost-effective with a discount of 44.6 and 36.9 percent of the current price of RotaTeq® and Rotarix®, respectively.
ConclusionsUniversal vaccination would not be a cost-effective strategy for Spain with either of the two vaccines at current prices. Vaccination of high-risk newborns would be cost-effective at current prices and from a societal perspective only with Rotarix®. Substantial vaccines price reductions could make the universal vaccination a cost-effective option in Spain.
PP209 Analysis Of The Efficacy And Safety Of Robotic Spinal Surgery
- María del Mar Polo-deSantos, Setefilla Luengo-Matos, Ana Isabel Hijas-Gómez, Esther Elena García-Carpintero, Luis María Sánchez-Gómez
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 37 / Issue S1 / December 2021
- Published online by Cambridge University Press:
- 03 December 2021, p. 27
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Introduction
Robotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.
MethodsA systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.
ResultsEight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.
ConclusionsWe found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.
PP264 Effectiveness And Safety Of Pressurized Intraperitoneal Aerosol Chemotherapy For Peritoneal Carcinomatosis: A Systematic Review
- Ana Isabel Hijas-Gómez, Nadia Lingán-Cubas, Mª Mar Polo-de-Santos, Esther García-Carpintero, Setefilla Luengo-Matos, Luis María Sánchez-Gómez
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 36 / Issue S1 / December 2020
- Published online by Cambridge University Press:
- 28 December 2020, p. 23
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Introduction
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a minimally invasive therapeutic option for stage IV or terminal stage peritoneal carcinomatosis, which has a very low survival rate. PIPAC is aimed at patients whose only therapeutic alternative is systemic chemotherapy because they are unable to undergo other treatments, such as cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. PIPAC consists of a micro-pump connected to a double-contrast injector, which is used to apply cytotoxic agents laparoscopically using pressurized aerosols. The objective of this study was to update the evidence regarding the effectiveness and safety of PIPAC.
MethodsA systematic review (SR) was conducted by searching PubMed, Embase, and The Cochrane Library database. ClinicalTrials.gov and the European Union Drug Regulating Authorities Clinical Trials Database were consulted to identify registered clinical studies. All articles published up to April 2019 were considered for inclusion. Abstracts, letters, single case studies, non-clinical and animal studies, and studies published in languages other than English or Spanish were excluded. Validated checklists were used to assess the quality of the included studies.
ResultsSeventeen studies were included (three SRs and fourteen cases series) and eighteen ongoing clinical trials were identified. The quality of the SRs and cases series studies was low and moderate, respectively. Adverse events were categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events as grade 1–2 (mild-moderate: 11% to 40% of patients) and grade 3–4 (severe-fatal: 0% to 37% of patients). Overall complete histological regression according to the Peritoneal Regression Grading Score and the Peritoneal Cancer Index occurred in at least sixty percent of patients. The survival time ranged from 11 to 16 months.
ConclusionsEffectiveness data for PIPAC were promising, with high carcinomatosis regression rates. Most studies showed a moderate safety profile, with generally mild to moderate complications (nausea, abdominal pain, and vomiting). This is an advantage over systemic chemotherapy, which has severe systemic side effects. Economic evaluation studies are needed to estimate the cost effectiveness and cost utility of this technology. Diffusion of PIPAC is expected, but the criteria used to select patients in the studies carried out so far must be considered, as well as the need to follow strict safety protocols for preventing leakage of aerosolized cytotoxic drugs.
VP35 Effectiveness and Safety of Cyanoacrylate Ablation for Varicose Veins
- Esther García-Carpintero, Montserrat Carmona, Juan Pablo, Chalco Orrego, Jesús González-Enríquez, Iñaki Imaz-Iglesia
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 85
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Introduction
Treatment of varicose veins is currently performed by different interventionist alternatives that include surgical, endothermal and non-thermal ablation therapies. The main guidelines recommended endovenous thermal treatment as the first choice therapy; however present side effects related to thermal energy. Non-tumescent endovenous ablation techniques such as cyanoacrylate ablation (CA) started to develop to avoid these problems. The objective of this study is to assess the effectiveness and safety of CA for saphenous vein incompetence.
MethodsA systematic review with meta-analysis was carried out. The search of scientific literature was performed in Medline, Embase, Cochrane library, CDR, WoS and Scopus databases. GRADE methodology was used to assess the quality of the evidence and Cochrane risk of bias tool to assess methodological quality of randomized control trials (RCT). Pooled risk ratio was calculated using a random effects model.
ResultsTwo RCTs and one non-RCT comprising 1,077 participants were included. Additionally, 10 case series were included for safety assessment. Pooled analysis of closure rates by the two RCTs indicated there were not significant differences between CA and radiofrequency ablation (RFA) or endovenous laser ablation (EVLA). Improvements in venous clinical severity score were reported by all comparative studies without significant differences among groups. The most frequently reported adverse events were ecchymosis, phlebitis, paraesthesia, and thrombosis. The pooled analysis showed significant differences only in ecchymosis rates, with lower probability of ecchymosis in CA groups. CA treatment showed lower pain rates and shorter intervention times and recovery compared to endothermal therapies.
ConclusionsThe effectiveness of CA devices in the treatment of varicose veins is comparable to EVLA and RFA, while the rates of adverse effects are lower. Despite the limitations of the evidence, CA may be a promising alternative to existing treatments, with the advantages of better patient comfort.
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