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VP18 Antibiotics And Orthopedic Surgery Without Implant: A Meta-Analysis
- Sophia Campbell Davies, Chiara Inserra, Gaetana Muserra, Angelo Bignamini, Paola Minghetti
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 163
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Introduction:
According to guidelines, antibiotic prophylaxis in orthopedic surgery without implant is not recommended for the reduction of the incidence of surgical site infections (SSI); however, the evidence level is low. Surveys have shown that preoperative antibiotics for orthopedic procedures without implant are administered routinely by surgeons due to medico-legal concerns. Such practice may have an important impact on costs, side effects and the emergence of antibiotic resistance. Therefore, the objective of the review is to evaluate existing clinical evidence.
Methods:A systematic review was performed with the use of Pubmed, EMBASE/MEDLINE, CENTRAL, SBBL-CILEA/METACRAWLER, ISRCTN Registry, ICTRP and ClinicalTrials.gov databases. Trials were initially screened by the title and abstract; secondly, full papers were analysed. The meta-analysis included randomized controlled trials (RCT) with patients undergoing surgery as treatment for any orthopedic impairment that did not need implantation. Heterogeneity analysis of the studies was conducted with chi-square. The statistical analysis of the infection rate was performed using the meta package with the R software. The effect estimate was expressed in risk ratio (RR) and pooled using a random effects model. Study quality assessment was undertaken using the Jadad scale.
Results:Of the 184 identified papers, 129 were excluded since they did not meet inclusion criteria and 45 were discarded because they were considered to be duplicate publications. After analyzing the 10 potentially relevant studies, only two were included. The study population consisted of 1,152 patients. No heterogeneity was observed; however, the studies were outdated and associated with a high risk of bias. According to the pooled RR, the incidence of infection in the intervention group was lower than the control group favoring prophylaxis (RR = 0.39, 95% CI: 0.16−0.96, p = 0.040).
Conclusions:The meta-analysis demonstrated, in contrast to the guidelines, that antibiotic prophylaxis can reduce the incidence of SSI in elective orthopedic surgeries without implant; however, the low number of available studies and the high risk of bias show that the effect estimate is not statistically significant. Considering that antibiotic prophylaxis is usually administered in clinical practice, RCTs are required to establish whether antibiotic prophylaxis in orthopedic procedures without implant is recommended or if this practice could cause more harm.
VP17 Hepatitis C Virus Treatment: A Meta-Analysis Of Long-Term Efficacy
- Chiara Inserra, Sophia Campbell Davies, Mariagrazia Piacenza, Angelo Bignamini, Paola Minghetti, Grazia Zerega
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 162-163
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Introduction:
The efficacy of second generation direct-acting antiviral agents (DAAs-2), in terms of sustained viral response (SVR) 12 weeks after the end of treatment (EOT), has widely been proven; however, long-term efficacy is still controversial due to the low number of available studies with a small number of patients. The objective of this study is to conduct a systematic review and, if possible, a meta-analysis of existing clinical evidence of the long-term efficacy (SVR longer than 12 weeks after EOT) of DAAs-2 for hepatitis C virus (HCV) treatment.
Methods:A systematic review was performed with the use of CENTRAL, MEDLINE, Embase, Pubmed and SBBL-CILEA/METACRAWLER databases. Trials were initially screened by the title; secondly, full papers and abstracts were analysed. The meta-analysis included randomised controlled trials (RCTs) with adult patients affected by HCV, treated with DAAs-2 and assessed for longer than 12 weeks after EOT. Study quality assessment was undertaken using the Jadad scale. Heterogeneity analysis of the studies was conducted with chi-square and I2. The statistical analysis of the efficacy rate was performed using the meta package with the R software. The effect estimate was expressed in risk ratio (RR) with 95% confidence interval (CI 95%) and pooled using a random effects model.
Results:Of the 106 identified studies, 11 high quality RCTs were included for meta-analysis (25 were duplicate publications, 70 did not meet the inclusion criteria). Considered genotypes were 1 (n = 9), 2 (n = 1), 3 (n = 1). Meta-analysis included 3,720 patients (2,698 treated with DAAs-2; 1,022 treated with placebo or a first generation DAA±Ribavirin±Pegylated interferon). Heterogeneity between studies was high (p<0.001; I2 = 90.2%); however, it was absorbed by the model (τ2 = 0,08). Long-term efficacy was expressed as SVR 24 weeks after EOT, since longer timescales were not available. According to the pooled RR, the incidence of efficacy was 1.5 (CI 95%: 1.24−1.83, p < 0.001).
Conclusions:The meta-analysis demonstrated that DAAs-2 for HCV treatment have long-term efficacy at SVR 24 weeks after the EOT; however, the number of studies is mostly based on genotype 1. More RCTs are required to confirm long-term efficacy at more than six months after EOT for all treated genotypes.
OP61 Cost-Utility Analyses Of Biologics For Refractory Ulcerative Colitis
- Sophia Campbell Davies, Chiara Inserra, Gaetana Muserra, Mariagrazia Piacenza, Sandro Ardizzone, Tommaso Saporito
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 27
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INTRODUCTION:
Although many biologics (Bs) have been approved for the treatment of moderate-to-severe Ulcerative Colitis (UC) in patients who have responded inadequately to conventional therapy, the selection of Bs is controversial due to the lack of head-to-head trials. Indirect economic comparisons of these costly drugs are available from National Healthcare perspectives that are not the Italian ones. Therefore, the objective is to evaluate cost-utility of Bs for the treatment of refractory moderate-to-severe UC both in Italy and in the Lombardy Region.
METHODS:A Markov model (considering three transition states: remission, clinical response, relapse) was constructed using the software R 3.3.1 markovchain-package to evaluate incremental cost-utility ratios (ICUR) of adalimumab (ADA), infliximab (IFX), infliximab biosimilar (IFX-B), golimumab (GOL) and vedolizumab (VED) treatments of patients over a 10-year time horizon from the perspective of the Italian (N) and Lombardy Region (R) healthcare system. Clinical parameters were derived from clinical trials. Costs (actualized by – 1.5 percent) were obtained from the National database and Regional public tender. Utility was expressed as QALY (Quality-Adjusted Life Years).
RESULTS:Costs per treatment were different from a N and R perspective (ADA -55 percent; IFX -16.7 percent; IFX-B -29.6 percent; GOL -9.6 percent; VED -10 percent). Direct healthcare costs (treatment cost, visits, laboratory tests, hospital admissions) were calculated over 10 years of treatment per patient: ADA (N: EUR114,227, R: EUR68,314, -40.2 percent), IFX (N: EUR130,595, R: EUR103,081, -21 percent), IFX-B (N: EUR110,438, R: EUR78,852, -28.6 percent), GOL (N: EUR118,602, R: EUR96,922, -18.3 percent), VED (N: EUR113,852, R: EUR102,932, -9.6 percent) with associated QALY respectively of 6.68, 6.66, 6.66, 6.70, 7.02. From a N perspective, IFX-B was dominating compared to all other treatments. The ICUR of VED/IFX-B was EUR9,483 for 10 years (willingness to pay EUR948/QALY). From a R perspective, ADA was dominating compared to all other treatments. The ICUR of VED/ADA was EUR101,818 for 10 years (Willingness to Pay, WTP EUR10,182/QALY).
CONCLUSIONS:National and Regional cost-utility analyses produced different results. As Regional price discounts can occur, local analysis is needed to estimate the economic impact of therapies to ensure optimal choice.