bluuebunny/crossref_metadata_2025_split huggingface dataset:
PD47 Implanted Hypoglossal Nerve Stimulation For Obstructive Sleep Apnea
Authors: Orrego Juan-Pablo Chalco , Polo-Desantos Mar , Sánchez-Gómez Luis María , Luengo-Matos Setefilla 
Published: January 2019

Introduction:The hypoglossal nerve stimulation (HNS) produces a tongue protrusion for the treatment of mod-severe obstructive sleep apnea (OSA). It is one of the emerging health technologies prioritized to assess its possible inclusion on the Spanish National Health System. The objective of this study is to evaluate the efficacy and safety of this system in the treatment of OSA.Methods:An early assessment (horizon scanning) was performed. The searched databases were: PubMed, WOS, Tripdatabase, Dynamed, Cochrane Library and ICTRP. Clinical studies of OSA patients treated with HNS published until 01 March 2017 were reviewed. Outcomes considered were: AHI (Apnea Hypopnea Index) ODI (Oxygen Desaturation Index) ESS (Epworth sleepiness scale) and AE (adverse events).Results:Four devices of HNS were founded: Inspire™, HGNS®, Aura6000™, and Nixoah™. We found two randomized controlled trials (RCT). The Inspire™ RCT showed significant results on mean differences on AHI (−16.9, 95% CI −24.7 to −9.0); ODI (−15.1, 95% CI −22.7 to −7.5) and ESS (−4.5, 95% CI −7.5 to −1.4) in 46 patients, after one week of follow-up. The HGNS® RCT showed non-significant differences on AHI (device active 22.1 ± 5.2 vs control 29.7 ± 6.2), ODI (11.4 ± 4.1 vs 19.5 ± 5.2) and ESS (9.8 ± 1.0 vs 14.1 ± 2.5) in 21 patients at 6 months. A systematic review that included 6 cases series (3 with HGNS®, 2 with Inspire™ and 1 with Aura6000™) without device subgroup analysis and 7 cohorts studies (6 with Inspire™ and one with Aura6000™) showed significant differences comparing AHI, ODI and ESS results to before treatment values. Major AE reported from the studies varied from 4 to 4.5%. No study with Nixoah™ was found.Conclusions:Inspire™ seems to be an effective option for OSA patients although the evidence is scarce and of low quality for all HNS devices. It would be necessary further well-designed studies.
PD53 Efficacy And Safety Of Nicotinamide In Hemodialysis Patients
Authors: Hussain Salman , Singh Ambrish , Habib Anwar , Najmi Abul Kalam 
Published: January 2019

Introduction:Hyperphosphatemia is a most common problem in dialysis patients. Phosphorus imbalance in dialysis patients increases the risk of developing the bone mineral disorder and cardiovascular mortality. Randomized controlled trials (RCTs) presented variable findings concerning the reduction of phosphorous level in nicotinamide user. So, this systematic review is aimed to explore the efficacy and safety of nicotinamide in hemodialysis patients.Methods:This systematic review was conducted by adhering to the PRISMA guidelines. Study for inclusion was identified by running the suitable keywords in databases including PubMed, Embase, and Cochrane central from inception to 31 October 2017. Cochrane risk of bias tool was used to judge the quality of included RCTs. The change in serum phosphorus level was the primary outcome, while the change in other biochemical parameters including serum calcium, calcium-phosphorus product level, iPTH, platelets, lipid profile parameters, and the safety profile was considered under secondary outcomes. Review Manager (RevMan v5.3) was used for statistical analysis.Results:Finally four articles were qualified for inclusion in this study with a total of 274 participants of which 136 were in the treatment (nicotinamide) group. All the included studies showed statistically significant reduction in mean serum phosphorous, calcium-phosphorus product level in the treatment arm at the end point of the study, while the reduction in the placebo group was not statistically significant in all the studies. Among other biochemical parameters analyzed, only high-density lipoprotein (HDL) was found to be significantly increased from baseline to the endpoint of the study in the nicotinamide group, while the placebo group showed no significant change in all the included studies except the study by Shahbazian et al. Thrombocytopenia was the most commonly reported adverse event in the treatment group followed by diarrhea.Conclusions:Nicotinamide was found to be effective in the management of hyperphosphatemia in hemodialysis patients. The safety profile was found to be satisfactory.
PD55 Diagnostic Accuracy Of Line Probe Assay Technique Compared To Sensitivity Test
Authors: Leite Betânia , Gomes Dalila , da Mata Fabiana 
Published: January 2019

Introduction:Antimicrobial resistance is a serious public health problem at the global level. The sensitivity test in liquid and solid media-based techniques is traditionally used in Brazil for the diagnosis of resistant tuberculosis (TB). However, the time required for the diagnosis of this test is, on average, 60 (sixty) days, a period considered to be very high, especially considering certain vulnerable populations (street dwellers), since the long time to the result of the test makes it difficult to establish a second contact between the health institution and the individual, resulting in people without access to diagnosis and appropriate treatment. The line probe assay (LPA) technique often replaces the use of the sensitivity test in many countries, being considered of low time for the diagnosis, ranging from 24 to 48 hours.Methods:We searched the Medline databases (via Pubmed), Embase, and The Cochrane Library, with the aim of finding systematic reviews with meta-analyses. The articles were screened by titles and abstracts and later the full text reading was carried out, according to the inclusion criteria.Results:Three systematic reviews with meta-analysis were selected. The interventions evaluated the LPA technique compared to the conventional drug sensitivity test. The evaluated tests showed good performance as rapid screening tests for resistance to rifampicin in high prevalence sites. However, although the test results for resistance to isoniazid showed good specificity, there was a high variability in sensitivity estimates.Conclusions:This study reinforces the idea that the LPA technique may contribute to the previous diagnosis, and this is a probable strategy to control the disease, especially in vulnerable populations that are more likely to be affected by tuberculosis. For a broader analysis of the benefit of the technique, further studies are suggested.
PD62 Off-Label Use Of Medicines For Public Health Needs
Authors: Mega Tacila , Rabelo Roberta , Vidal Juliana , de Brito Artur Felipe 
Published: January 2019

Introduction:The use of drugs for clinical conditions that differ from those approved in prescribing information (product labels) is known as off-label use. In Brazil, the Brazilian Health Regulatory Agency (ANVISA) is the official organization that regulates the use of health technologies. For technologies to be incorporated into the Brazilian public health system, registration with ANVISA is mandatory. However, occasionally, it is necessary to evaluate technologies for off-label use in the interests of public health. This study aimed to identify the health technologies recommended by the National Committee for Health Technology Incorporation (CONITEC) with an off-label indication between January 2012 and October 2017.Methods:A descriptive study was undertaken using data available on the CONITEC website.Results:The study identified seven drugs with a favorable recommendation for off-label use: everolimus, sirolimus, and tacrolimus as immunosuppressants in transplant recipients; clozapine for bipolar affective disorder; pentoxifylline for cutaneous leishmaniosis mucosa; risperidone for adults with autism spectrum disorder, and bevacizumab for age-related macular degeneration and diabetic macular edema. For these decisions the Committee considered the scientific evidence available for the indication proposed, the severity of the disease, and the existence or absence of alternative treatments. This was possible because Brazilian legislation allows ANVISA to authorize the off-label use of health technologies provided that the analysis is supported by scientific evidence regarding effectiveness, accuracy, and safety for the intended purpose.Conclusions:The off-label use of health technologies is a worldwide practice that can favor vulnerable populations and neglected diseases. This practice should be seen as positive when there is evidence supporting off-label use, and such decisions should not be influenced by political, economic, or marketing considerations.
PD64 Diagnostic Accuracy Of The Nitrate Reductase Assay Technique
Authors: Gomes Dalila , Leite Betânia , da Mata Fabiana Araujo Figueiredo 
Published: January 2019

Introduction:The conventional drug sensitivity test is traditionally used in Brazil to diagnose drug-resistant tuberculosis. However, the test can take up to 60 days to return a diagnosis, which is considered too long for certain vulnerable populations. Therefore, this study analyzed the available scientific evidence on the accuracy and time to diagnosis of the nitrate reductase assay for diagnosing resistant tuberculosis, compared with the conventional drug sensitivity test.Methods:We searched MEDLINE, Embase, and The Cochrane Library for systematic reviews with meta-analyses. The articles were screened by title and abstract. The full-texts of potentially relevant articles were then screened according to the inclusion criteria.Results:Three systematic reviews with meta-analyses were selected that compared the nitrate reductase assay with the conventional drug sensitivity test. The accuracy of the nitrate reductase assay was satisfactory in most of the results when compared with the sensitivity test, except for one study that showed low sensitivity for the detection of streptomycin resistance. In addition, the nitrate reductase assay had a shorter time to diagnosis than the drug sensitivity test.Conclusions:The results of this study reinforce the idea that the nitrate reductase assay may diagnose drug-resistant tuberculosis earlier than the conventional drug sensitivity test and be a helpful strategy for controlling the disease, especially in vulnerable populations that are more likely to be affected by tuberculosis. For a broader analysis of the benefit of the assay, it is suggested that studies investigate the impact of the shorter time to diagnosis on morbidity and mortality in patients with drug-resistant tuberculosis. In addition, economic analyses comparing the nitrate reductase assay with the sensitivity test are recommended to evaluate the cost-benefit ratio.
VP02 Real-World Evidence (RWE) And CADTH Pan-Canadian Oncology Drug Review
Authors: Han Dolly , Tiruneh Missale , Chambers Alexandra , Haynes Adam 
Published: January 2019

Introduction:The pan-Canadian Oncology Drug Review (pCODR) program was established by Canada's provincial and territorial Ministries of Health (except Quebec) to assess cancer drug therapies and make recommendations to guide drug reimbursement decisions. The pCODR Expert Review Committee (pERC) makes reimbursement recommendations, providing a rationale for the recommendation and next steps for stakeholders. The objective of this analysis was to identify reviews and reasons pERC has requested real-world evidence (RWE) data collection.Methods:A retrospective analysis of pERC Final Recommendations (January 2012 – May 2017) was conducted. pERC Final Recommendations include drug information, reimbursement recommendation, rationale for recommendation following pERC's Deliberative Framework (clinical benefit, patient-based values, economic evaluation, and adoption feasibility), next steps for jurisdictions to consider to support their funding decisions, summary of deliberations, and evidence in brief. Reviews were included if there was a next step advising the collection of RWE to reduce uncertainty in the drug under review.Results:Out of eighty-four reviews, forty-one (forty-eight percent) included a next step to collect RWE to address a gap in the available evidence. Reasons for RWE data collection, in descending order of frequency, were to inform: sequencing of available therapies; magnitude of clinical benefit and cost-effectiveness or the true cost-effectiveness; duration of treatment and cost-effectiveness; defining the population or disease progression; quality of life; and dosage.Conclusions:In almost half of pERC's recommendation there is an indication that there is a gap in the existing evidence that could potentially be addressed through the collection of RWE. This reflects the rising number of new cancer drugs, limited evidence supporting submissions (for example non-comparative studies), and newer drugs such as immunotherapies which may not have a fixed treatment duration. Further research includes development of mechanisms for RWE data collection to help inform pERC recommendations and assist stakeholders with adoption feasibility of reviewed drugs.
VP06 The Effectiveness And Ethics Of Prenatal Testing For Cystic Fibrosis
Authors: Kessels Sharon , Newton Skye , Carter Drew , Merlin Tracy 
Published: January 2019

Introduction:Cystic fibrosis (CF) is the most common autosomal recessive disorder in Caucasians, occurring in one out of every 2,500–2,800 births worldwide, and is associated with a high burden of disease. In Australia, prenatal testing for CF is indicated for pregnant couples identified as carriers or when a fetus is found to have an ‘echogenic bowel’ (FEB). We aimed to determine the effectiveness of prenatal CF testing and to assess ethical dimensions. A key challenge in assessing a prenatal test is selecting appropriate endpoints to indicate clinical effectiveness.Methods:A systematic review was conducted and a linked evidence approach was used to answer the effectiveness question. The literature on ethical considerations relating to prenatal testing was also reviewed.Results:No studies were identified on the direct effectiveness of prenatal CF testing or downstream consequences. Linked evidence showed good diagnostic performance with a test failure rate of 4.5 percent. Termination of pregnancy occurred in the majority of cases where two mutations were identified in a fetus of carrier parents (155/163; 95 percent), indicating testing impacts clinical management. In FEB cases with CF, termination occurred in around sixty-five percent of pregnancies. Both terminating a pregnancy and having a child with CF were associated with poor short term parental psychological outcomes. Evidence indicates prenatal testing leads to a decreased number of CF-affected births. However, ethical analyses indicated that ‘informed decisions’ should have been the primary outcome of interest.Conclusions:Proper counselling prior to testing ensures that the aim of prenatal testing is informing reproductive choices in a non-directive way, rather than decreasing the number of CF-affected births (which is ethically problematic). These results suggest that for health technology assessments undertaken on contentious topics, ethical analysis should be undertaken first so appropriate endpoints are selected for the subsequent systematic review of clinical evidence and for the economic model.
VP17 Hepatitis C Virus Treatment: A Meta-Analysis Of Long-Term Efficacy
Authors: Inserra Chiara , Davies Sophia Campbell , Piacenza Mariagrazia , Bignamini Angelo , Minghetti Paola , Zerega Grazia 
Published: January 2019

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.
VP26 A Critical Appraisal Tool For Systematic Mixed Studies Reviews
Authors: Hong Quan Nha , Pluye Pierre , Fàbregues Sergi , Bartlett Gillian , Boardman Felicity , Cargo Margaret , Dagenais Pierre , Gagnon Marie-Pierre , Griffiths Frances , Nicolau Belinda , O'Cathain Alicia , Rousseau Marie-Claude , Vedel Isabelle 
Published: January 2019

Introduction:Systematic mixed studies reviews are a type of systematic review that combine qualitative, quantitative and mixed methods studies. They are gaining in popularity due to their potential for providing in-depth answers to complex clinical problems and practical concerns. However, several challenges are encountered in systematic mixed studies reviews because of the heterogeneity of included study designs. One of these challenges is related to the quality appraisal of included studies. To address this challenge, a critical appraisal tool for assessing the quality of quantitative, qualitative and mixed methods studies was developed in 2007: the Mixed Methods Appraisal Tool (MMAT). The aim of this project was to strengthen the content validity of the MMAT.Methods:A new version of the MMAT was developed using the results from a literature review on critical appraisal tools and a modified e-Delphi study with methodological experts (n = 73) to identify the core relevant criteria to include in the MMAT.Results:The results of this project and the new version of the MMAT will be presented. The MMAT has three main characteristics. First, it can be used for different study designs since it includes criteria for qualitative, quantitative and mixed methods studies. Second, the MMAT focuses on the core relevant methodological criteria and has five criteria per category of study. Third, it includes specific criteria for assessing mixed methods studies.Conclusions:Currently, there exists over 500 critical appraisal tools, making the task of selecting the proper tools for use in systematic mixed studies reviews more difficult. The MMAT offers an alternative solution by proposing a unique tool that can appraise the quality of different study designs. Also, by limiting to core criteria, the MMAT can provide a more time efficient assessment.
VP40 Robotic Surgery: From Health Technology Assessment To State Health Policy
Authors: Fennessy Paul , King Richard 
Published: January 2019

Introduction:The aging population means more men are diagnosed with prostate cancer, resulting in greater demand for treatment. Robot-assisted radical prostatectomy (RARP) claims to offer additional benefits to patients and providers. The independent Victorian Health Technology Program Advisory Committee assessed safety, clinical effectiveness and cost effectiveness evidence and financial impact to inform policy, access and reimbursement decision-making by state government policy makers and public hospital providers.Methods:Public and private hospital activity and costs for 2008–09 to 2012–13 from the Victorian Admitted Episodes Database (VAED) and the Victorian Cost Data Collection (VCDC) were identified. Data were extracted and reviewed based on (i) DRGs M01A and B, (ii) primary diagnostic code C61 (ICD-10-AM), and (iii) Australian Classification of Health Interventions procedure codes for open (ORP), laparoscopic (LRP) and RARP, supplemented by Victorian Prostate Cancer Clinical Registry data. English language Health Technology Assessments (HTAs)/systematic reviews published January 2009 to January 2015 were identified and analysed with comparative clinical outcomes data for RARP vs. ORP and RARP vs. LRP analysed. Not all reported the same data and most outcomes data presented were odds ratios and risk ratios.Results:RARP offers patients a shorter length of stay (LOS) compared with ORP or LRP, but the procedure takes longer to perform. While RARP has similar safety and clinical effectiveness profiles compared with ORP and LRP, published data do not unequivocally demonstrate that RARP is superior to ORP or LRP in terms of clinical outcomes. RARP is more expensive than ORP and LRP. The cost differential increases when capital costs are taken into account. Cost offsets from a reduced LOS are insufficient to justify the higher cost.Conclusions:Since RARP produces similar clinical outcomes to ORP and LRP but at a higher cost, the Victorian Health Technology Program Advisory Committee considered the case for public sector support of RARP is weak and provided two recommendations: (i) State Government resources are not used to procure RARP capital equipment; (ii) public hospitals can refer patients to a RARP provider, provided costs are negotiated prior to patient transfer and fully covered by the referring hospital.
The New York City–New Orleans connection: Evidence from constraint ranking comparison
Authors: Carmichael Katie , Becker Kara 
Published: January 2019

AbstractNew York City English (NYCE) and New Orleans English (NOE) demonstrate remarkable similarity for cities located 1300 miles apart. Though the question of whether these dialects feature a shared history has fueled papers on the subject (Berger, 1980; Labov, 2007), there remain a number of issues with the historical record that prevent researchers from arriving at a consensus (Eble, 2016). This article presents linguistic evidence from constraint ranking comparisons of variable nonrhoticity andbought-raising in comparable contemporary samples of NYCE and NOE speakers. Findings demonstrate strikingly similar systems for (r), but dissimilar systems forbought-raising. We examine the results of our analyses in the context of evidence from previous comparisons of NYCE and NOE, concluding that the resemblance between the two dialects is likely due to diffusion from New York City to New Orleans, occurring in the 19th century beforebought-raising emerged in either variety.