bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP255 Epigenetic Profile Predicts Response To Immunotherapy In Patients With Non-Small-Cell Lung Cancer: An Early Assessment
Authors: Hijas-Gómez Ana Isabel , Polo-de-Santos Mª Mar , Luengo-Matos Setefilla , Carmona-Rodríguez Montserrat , Sánchez-Gómez Luís María 
Published: December 2020

IntroductionEpigenetics is an innovative discipline that aims to provide biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. The identification of therapeutic targets is of particular interest in cancer therapy for selecting groups of patients who may benefit most from an intervention. Understanding the relationships between the immune system and tumor cells has led to new immunotherapy-based therapies that provide a promising alternative to conventional cancer therapies. The aim of this study was to conduct an early assessment of a novel epigenetic signature (EPIMMUNE) that could predict response to programmed cell death protein 1 (PD-1) inhibitor immunotherapy in patients with non-small cell lung cancer (NSCLC).MethodsWe identified the novel epigenetic signature EPIMMUNE through the Early Awareness and Alert System, “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias in Spain (AETS-ISCIII). A literature search of PubMed, Embase, the Web of Science, the Trip database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, The Cochrane Library, and the Centre for Reviews and Dissemination databases was conducted. Clinical studies on EPIMMUNE published in English or Spanish up to August 2019 were reviewed.ResultsOnly one retrospective study was found. Identification of EPIMMUNE was accomplished through interrogation of the DNA methylation status of CpG sites in 142 samples from adult patients with NSCLC who were treated with PD-1 inhibitors. EPIMMUNE was defined by 301 CpG sites whose methylation status was significantly associated with clinical response (progression-free and overall survival). No studies assessing the long-term clinical utility, impact on therapeutic decision making, or economic implications of EPIMMUNE were found.ConclusionsThe EPIMMUNE signature could provide an accurate and valid biomarker for identifying patients with NSCLC who may benefit from treatment with PD-1 inhibitors. However, the technology is under development, and there is only a single study on detecting the EPIMMUNE epigenetic profile and identifying the DNA methylation profiles associated with increased survival after PD-1 inhibitor therapy. More diagnostic accuracy studies and prospective, long-term trials are needed to evaluate the clinical impact this technology may have on therapeutic decision making. Given the limited evidence available, further research is needed before the technology can be disseminated.
PP264 Effectiveness And Safety Of Pressurized Intraperitoneal Aerosol Chemotherapy For Peritoneal Carcinomatosis: A Systematic Review
Authors: Hijas-Gómez Ana Isabel , Lingán-Cubas Nadia , Polo-de-Santos Mª Mar , García-Carpintero Esther , Luengo-Matos Setefilla , Sánchez-Gómez Luis María 
Published: December 2020

IntroductionPressurized 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.
PP284 Volume-Result Relationship Analysis In Digestive Oncological Surgery In Spain By Using Health Data Records
Authors: Muñoz Laura , Puigdomènech Elisa , Cuscó Xavier Garcia , Velasco César , Espallargues Mireia 
Published: December 2020

IntroductionIn order to improve patients’ health outcomes, it is important to know the available evidence regarding centralization of surgical interventions for digestive cancer in hospitals with the highest volume of cases. We aim to describe and identify the number of annual interventions recommended by hospitals in order to maximize the health outcomes and efficiency for patients undergoing digestive cancer surgery during 2013–2016 in centers belonging to the Spanish National Health System (SNS).MethodsThe study design was a retrospective cohort study (patients aged ≥18 years). Data from Spanish public hospitals’ basic minimum set of data at hospital discharge for esophagus, stomach, liver, pancreas and rectum cancers was used. Age, sex primary/secondary diagnosis and procedures (Charlson index) were included. Reinterventions, hospital stay and in-hospital mortality were considered as the outcomes and measures of efficiency. Hospitals were grouped as low-/medium-/high-volume according to the number of annual procedures. Descriptive analysis and logistic and Poisson regression models with Stata16 were undertaken.ResultsHigh-volume hospitals performed between 67.4 (rectum) and 88.6 (liver) percent of interventions. The percentage of in-hospital mortality for all cancers was lower in high-volume centers (9.6% esophagus, 6.6% stomach, 7.1% pancreas, 4.2% liver and 2.2% rectum), showing a negative association between center volume and in-hospital mortality, which was statistically significant for esophagus (odds ratio [OR] = 0.48; 95% confidence interval [CI]: 0.28–0.81), stomach (OR = 0.51; 95% CI: 0.39–0.68) and rectum (OR = 0.63; 95% CI: 0.48–0.83) cancers. A non-statistically significant lower in hospital stay was observed in high-volume hospitals.ConclusionsThese results indicate that in Spain there is a negative association between the number of digestive oncological interventions per hospital and in-hospital mortality. This could help to define a threshold or cut-off point for the concentration of digestive cancer surgery in the SNS that might result in an improvement of lower in-hospital mortality and/or hospital stay.
PP288 Health Technology Assessment In Universal Health System: A Network At The Brazilian Capital
Authors: Silva Galdino Johnathan Portela Da , Silva Everton Macêdo , Tiziani Valdenize , Pereira Daniella Cristina Rodrigues , Camargo Erika Barbosa , Elias Flávia Tavares Silva 
Published: December 2020

IntroductionCollaborative networking is adopted to implement health technology assessment (HTA) in academic and research institutions and exchange knowledge with hospitals and health services. Since 2016, the District Network for Health Technology Assessment (ReDAPTS) has been dedicated to generating and promoting evidence that supports decision-making, promoting continuous qualification, supporting and guiding managers in priorities and demands, analysing the economic, ethical and social implications of problems and situations, and contributing to healthcare quality at the Unified Health System. The objective of this study is to present the construction process of ReDAPTS from 2016 to 2019.MethodsThis experience report about ReDAPTS considered three main actions: (i) situational diagnosis in 2016 and 2017, (ii) agreements of internal regulation and governance and (iii) HTA training strategies for professionals. The scientific events and executive group meetings were described to identify the strategies for the implementation of a collaborative network in the Federal District (FD), Brazil.ResultsIn total, fifteen institutions were identified with a potential to develop the HTA field at the district level. Between 2016 and 2019, three scientific events, eighteen technical meetings for network governance and two scientific meetings were carried out, organized by ReDAPTS and with 269 participants, highlighting assistance and university hospitals, FD Department of Health and academic and research institutions. Four HTA courses were offered and 319 professionals from the FD were trained.ConclusionsCollaborative networking provided strengthening capacity for study production and debates on institutional processes for public health policies at the FD. Networking encouraged collaboration between institutions and promoted sharing HTA experiences. The network faces challenges to operate with full capacity. Political and institutional commitment, physical infrastructure and trained personnel sustainability are key to maintaining the HTA process at the FD. Institutions can develop HTA-teams to promote continuous qualification, study production and the rational use of technologies.
PP352 Systematic Review Of Clinical Effects Of Different Thermal Insulation Measures In Patients Undergoing Major Surgery
Authors: Xu He , Lu Yijuan , Guan Xin , Ma Aixia , Tang Wenxi 
Published: December 2020

IntroductionHypothermia (core temperature <36°C) during major surgeries could result in a number of adverse events such as surgical site infection, bleeding, and prolonged hospital stay. The incidence of intraoperative hypothermia was 44.3 percent in China in 2015, with only 10.7 percent of patients receiving effective hypothermia prevention measures during major surgeries. By systematically examining the adverse risks for patients using different warming measures (active and passive), our study discussed the potential of bringing the most effective one(s) into clinical guidelines.MethodsArticles, ongoing trials and grey literatures were retrieved from PubMed, The Cochrane Library and Clinical Trials till February 2019. Bair HuggerTM (BH) was determined to be the reference group and all randomized controlled trials including BH were included. In the control group, we kept all possible warming measures. Adverse effect indicators were decided using scoping reviews and then applied in literature screening. Type (open/endoscopic) and length of surgery were included in sub-group analysis.ResultsA total of forty-two studies were included, with twenty-seven of them passive insulation measures and fifteen active measures. Compared with passive measures, BH had significant advantages, such as in surgical site infection (risk ratio [RR] = 0.13, 95% confidence interval [CI]: 0.05, 0.80), chills (RR = 0.37, 95% CI: 0.25, 0.54) and hospitalization stay (mean difference [MD]=−1.27d, 95% CI: -2.05, -0.48). Compared with active insulation measures, BH had no significant advantages. Patients with open or longer surgeries (≥2 hours) experienced higher risks.ConclusionsGenerally, an active warming system is more effective in lowering risks (e.g., hypothermia, surgical site infection, chills, length of stay) than passive ones, especially for patients going through non-endoscopic or longer surgeries. Among the active warming systems, BH does the same job as other active insulation measures. Given that the practice of peri-operative hypothermia prevention using active warming systems is not popular in China, the use of BH and other active insulation measures during major surgeries are recommended to improve the safety and potentially reduce the cost of treating those clinical adverse events.
PP434 Quality Of Studies Submitted To Support Requests For Medical Devices And Equipment Incorporation In A Teaching Hospital
Authors: Kny Katiuce Tomazi , Pires Ferreira Maria Angélica 
Published: December 2020

IntroductionIn hospitals with standardized processes of health technology assessment (HTA), clinical studies are usually required to support incorporation requests. Factors such as conflicts of interest and confirmation bias affect the quality of the evidence. The objective of this study was to assess the quality of studies submitted to the university hospital to support the incorporation of non-drugs technologies.MethodsAll submissions received from 2017 to 2019 were reviewed. Data about methodological quality of studies sent by requesters and their utilization of final recommendation were collected, as well as about studies retrieved during additional search performed by HTA. The Jadad and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) scales were used for assessing the quality of randomized clinical trials (RCTs) and systematic reviews (SRs), respectively.ResultsTwenty-one requests for incorporation of equipment were analyzed. The average number of studies attached was 4.5. In eight requests (53.3%), both SRs and RCTs were attached. In seven (46.7%) only low quality studies were included were included; additional search identified RCTs and SRs in four of these cases. According to the Jadad and AMSTAR scales, 60 percent of the submitted RCTs showed a high risk of bias, while 57 percent of the SRs showed moderate quality, respectively.ConclusionsThe best evidence is not always submitted during the incorporation request process. Requirements for studies of moderate-to-high quality to accept the incorporation demand could be helpful to avoid inefficiencies in hospital-based HTA.
PP482 Invasive Electroencephalography In The Pre-Surgical Diagnosis Of Pharmacoresistant Epilepsy
Authors: Avdeyev Andrey , Shpekov Azat , Benberin Valeriy , Shanazarov Nasrulla , Ismailova Leilya , Akhmedullin Ruslan , Nurmasheva Arailym 
Published: December 2020

IntroductionWorldwide, more than 50 million people suffer from epilepsy, and there are 16–51 new cases per 100,000 population each year. Up to 30 percent of patients with epilepsy are pharmacoresistant, who are candidates for surgical treatment. Invasive electroencephalography (iEEG) is a mandatory method in the arsenal of epileptic centers, and is gradually becoming the gold standard for invasive determination of boundaries between the affected and functional zones of the cortex and subcortical brain. Treatment costs correlate with the severity of the disease, with patients having uncontrolled seizures incurring eight times the costs compared to those with controlled epilepsy.MethodsTo assess the clinical and cost-effectiveness of the iEEG in the pre-surgical diagnosis of pharmacoresistant epilepsy, a systematic search of literature by keywords in the MEDLINE database was conducted. The search resulted in sixty-six articles. The analysis included twenty studies that met the search criteria.ResultsMost studies including meta-analysis show very low rates of complications of iEEG. Literature data demonstrate cost-effectiveness of the method in patients with pharmacoresistant epilepsy in comparison with continued antiepileptic drug therapy. As an integrated method, rather than a simple method, it takes maximum account of clinical, neurophysiological and anatomical-functional data to achieve accurate localization of the epileptogenic zone. Currently, iEEG is a clinically effective method to improve the safety and specificity of resective surgery.ConclusionsWith the use of iEEG, mortality and disability of patients with pharmacoresistant epilepsy will be significantly reduced. It has also been proven that epilepsy surgery leads to significant financial savings in the treatment of pharmacoresistant epilepsy. The results of the clinical and economic evaluation (mini-HTA report) have been submitted to the Ministry of Healthcare for decision-making on including iEEG in government reimbursement system.
PP499 Disinvestment Supported By A Hospital-Based Health Technology Assessment Unit: A Case Of A Teaching Hospital In Brazil
Authors: Schlatter Rosane Paixão , Kny Katiuce Tomazi , Ferreira Maria Angelica Pires 
Published: December 2020

IntroductionThe Hospital de Clínicas de Porto Alegre (HCPA), a public teaching hospital, has a Hospital-based Health Technology Assessment (HB-HTA) unit to support the decision-making process on technology incorporation, rationalization or disinvestment. In 2017, the plastic adhesive drape was standardized at HCPA for use in cardiovascular, digestive, orthopedic, and neurological surgery for the purpose of preventing surgical site infection (SSI). This study evaluated whether the plastic adhesive drape technology is more effective than the no adhesive drapes in the surgical procedures in which it is used in the HCPA, so as to support the medical board's decision regarding the rationalization of use.MethodsThe primary outcome was the surgical site infection rate (SSI). Searches were performed in PubMed, Cochrane and national and international health agencies: World Health Organization (WHO), National Institute for Health and Care Excellence (NICE), Centers for Disease Control and Prevention (CDC), Society for Healthcare Epidemiology of America (SHEA), Brazilian National Commission for the Incorporation of Technologies (CONITEC) and Brazilian National Health Surveillance Agency (ANVISA) databases. The search strategy combined terms related to the technology and types of surgery in which it is used in the HCPA. The quality of the included studies was assessed. Additionally, data on technology utilization and costs in the hospital were analyzed.ResultsTechnology assessment followed AdHopHTA project recommendations. Data from the hospital showed that the technology has been used in fifteen surgical specialties, different from the proposed incorporation, with a progressive increase in consumption from 2017 to 2018. The literature review included a systematic review with seven clinical trials, which concluded that the plastic adhesive drape lacks benefits, with potential for increased risk of SSI. The evidence was of moderate quality.ConclusionsThe expenses associated with the use of the technology were considered unjustified as it is not reimbursed by the Brazilian Ministry of Health and its disinvestment was recommended. The Medical Board approved the disinvestment of the technology based on the evidence found by the HB-HTA unit, and the medical staff complied with the decision.
PP506 Health Technology Reassessment (HTR) Of A Non-Drug Technology: Methods Used By A Regional HTA Unit
Authors: Poirier Marie-Belle , Benkhalti Maria , Joncas Jérémy , Warrari Ouifak El , Addad Aghiles , Cheng Sonia , Mior Frédéric , Méziat-Burdin Anne , Dagenais Pierre 
Published: December 2020

IntroductionAn environmental scan conducted by the Canadian Agency for Drugs and Technologies (CADTH-March-2019) revealed that several health technology assessment (HTA) organisations are currently developing standard health technology reassessment (HTR) processes. Here we present methods used to conduct an HTR of a prioritization programme for non-immediate life-threatening urgent surgeries implemented in 2017 at a tertiary referral hospital in (Quebec-Canada). This HTR initiative was conducted by a regional HTA unit to optimize the programme efficiency and resources utilization as well as to motivate change in the clinical community of other hospitals within its healthcare network. Patient and healthcare personnel satisfaction levels towards the programme were also considered.MethodsIn this case study, HTR methods and outputs were elaborated using elements presented in the CADTH environmental scan and relevant publications identified through PubMed and in the grey literature. Documents in English and French, published between January 2002 and March 2019 were considered. Key stakeholders were consulted to identify barriers of the programme implementation to other hospitals in regards to aspects related either to the local medical practice or organizational factors.ResultsThe prioritization process was conducted using the same tool applied for HTA appraisal with the additional criterion that the HTR could facilitate the programme implementation. The research processes used in this HTR included: i) systematic review of the literature, ii) hospital database search (efficacy and resource utilization), iii) perceptions of healthcare teams and patients. HTR outputs consist of specific recommendations on implementation barriers and methods to monitor the impacts of the programme.ConclusionsIn this evolving field, sharing lessons from HTR methods provides information to develop standard adaptable processes to different contexts. Hence, this work applies HTR to a healthcare programme while most of the literature focuses on the HTR processes on drug and interventional medicine disinvestment. These elements represented HTR methods used from prioritization appraisal, research processes for evaluation and outputs used to plan the implementation and finally monitoring from a regional HTA unit. It also showcases that HTR being conducted as a structured evidence-based assessment adds value to a healthcare programme and could also facilitate its implementation.