bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP61 Net Value Of Treating Hepatitis C With Newly Available Direct-Acting Antivirals
Authors: Bloom David E. , Khoury Alexander , Srinivasan V. 
Published: January 2019

Introduction:Recently developed direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV) are groundbreaking in their high efficacy across disease genotypes and lack of severe side effects. This study used a cost-of-illness (COI) approach to estimate the net value conferred by one of these novel drug combinations, sofosbuvir and velpatasir (SOF/VEL), recently licensed for generic manufacture in India.Methods:This study considered COI from lifetime earnings lost due to disability and premature death from HCV infection. Risk of death and disability in future years was calculated using a Markov state-transition model with parameters determined from the literature. The future earnings of sampled patients were predicted using an empirical earnings model, with coefficients determined from India Human Development Survey data. Costs to both the patient and secondarily infected individuals were considered.Results:Preliminary results suggested that curing individuals diagnosed with chronic HCV in India would preserve INR 3.7 million (USD 55,750) in earnings per person. For non-cirrhotic (NC) and compensated cirrhotic (CC) individuals, the expected benefits associated with preventing secondary infections were worth between one and forty-one percent of the value of benefits conferred to the diagnosed individuals (depending on sex and extent of liver damage). Treating decompensated cirrhotic (DC) individuals with DAAs alone offered minimal earnings benefits because these individuals will likely remain disabled and unable to work without a liver transplant. Expected net benefits of treatment were substantial for NC and CC patients, ranging from INR 640,349 (USD 9,531) for NC women to INR 10.7 million (USD 158,968) for CC men. The cost of treatment for DC individuals exceeded the expected earnings benefits.Conclusions:For average NC and CC individuals, the cost of treatment with SOF/VEL is offset by the benefits of increased future productivity. Increased earnings are not sufficient to offset the cost of treatment for DC individuals, but treatment may still be justified on the basis of the intrinsic value of health improvements and other treatment benefits.
OP66 Tumor Profiling Tests In Early Breast Cancer: A Systematic Review
Authors: Harnan Susan , Cooper Katy , Stevens John , Wong Ruth , Tappenden Paul , Bessey Alice , Ward Sue , Rafia Rachid , Stein Rob , Brown Janet 
Published: January 2019

Introduction:Tumor profiling tests can help to identify whether women with breast cancer need chemotherapy due to their risk of relapse, and some may be able to predict benefit from chemotherapy. We focused on four genetic tests: Oncotype DX (O-DX), MammaPrint (MMP), EndoPredict and Prosigna, and one immunohistochemistry test, IHC4, for the National Institute of Health and Care Excellence as part of their Diagnostic Appraisal Programme.Methods:A systematic review was undertaken, including searching of nine databases in February 2017 plus other sources including a previous review published in 2013. The review included studies assessing clinical effectiveness of the five tumor profiling tests, with or without clinicopathological factors, to guide decisions about adjuvant chemotherapy in people with ER-positive, HER-2 negative, Stage I-II cancer with 0 to 3 positive lymph nodes (LN). The PROBAST tool and Cochrane risk of bias tools were used to assess risk of bias.Results:A total of 153 studies were included; the strength of evidence base for individual tests was varied. Results suggest all tests are prognostic for risk of relapse, though results were more varied in LN positive (+) patients than in LN negative (0) patients. Evidence was limited about whether tests can predict benefit from chemotherapy (available for MMP and O-DX only). Studies that assessed the impact of the tests on clinical decisions indicate that the net change in chemotherapy recommendations or decisions pre-/post-test ranged from an increase of one percent to a decrease of 23 percent among UK studies, and a decrease of zero percent to 64 percent across European studies.Conclusions:The studies included in the review suggest that all of the tests can provide prognostic information on the risk of relapse; however results were more varied in LN+ patients than in LN0 patients. There is limited and varying evidence for prediction of chemotherapy benefit.
OP87 Nitrous Oxide As Sedation Regimen In Children—How To Assess Safety?
Authors: Pike Eva , Hafstad Elisabeth , Tjelle Torunn Elisabeth 
Published: January 2019

Introduction:Children who undergo short, painful procedures at hospitals are given different kinds of pain relief (analgesics), often in combination with drugs for relaxation (sedatives). Nitrous oxide (NO) is a drug administered for pain relief and relaxation, it is applied by inhalation and its effects are analgesic, anxiolytic and sedative. It is used in several countries, but is not normally used as a sedation method for children in Norwegian hospitals, although widely used in maternity wards during labor. Our aim was to evaluate the effectiveness and safety of this sedation regimen in children. However, we also wanted to assess safety for health personnel after repetitive or long-term exposure.Methods:We performed a systematic review on effectiveness and safety of nitrous oxide for sedation in children. For evidence on efficacy and safety in children, only randomized controlled trials (RCT) were included. For safety of health personnel we also accepted other study designs. For all endpoints, we presented the evidence in summary of finding tables.Results:We retrieved twenty-two randomized controlled trials on the effectiveness or safety in children undergoing sedation with nitrous oxide. Outcomes were hospital procedure satisfaction or characteristics, and pain relief. Safety was reported as acute adverse events. None of the RCTs reported evidence on safety for health personnel. We are currently exploring different ways to systematically assess safety for health personnel within the form of an HTA otherwise designed for a different population.Conclusions:Assessing safety of new technologies, methods or procedures through HTAs is a crucial point. However, assessing the long-term safety of the health personnel should also be included, but evidence will often not be retrieved through literature search designed for the patient group, and long-term safety data is in general difficult to retrieve for exposure to a novel technology. We will discuss our approach to this challenge.
OP88 Reduction Of Biologics In Rheumatoid Arthritis: A Systematic Review
Authors: Vasconcelos Leticia , Silva Marcus , Galvao Tais 
Published: January 2019

Introduction:Reduction of biologics after reaching low disease activity rheumatoid arthritis has been tested in clinical trials. The aim of this systematic review is to assess the effectiveness and safety of the reduction of biologics drugs in patients with rheumatoid arthritis in low disease activity.Methods:The protocol of this review is registered at PROSPERO (CRD42017069080). We searched MEDLINE, Embase, Scopus and The Cochrane Library for randomized controlled trials that reduced or spaced the dose of biologics in patients at low disease activity or remission state compared with maintenance. Two researchers selected studies, extracted the data, and assessed the risk of bias of the studies. Random effects meta-analyses by DerSimonian & Laird method were calculated considering intention to treat analysis to obtain the standardized mean difference (SMD) or relative risk (RR) and 95 percent confidence interval (CI). Quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE).Results:From 725 retrieved records, seven studies were included. Compared to regular doses, reduction of biologics significantly increased the health assessment quality (SMD = 0.20; 95% CI: 0.04 0.37; I2 = 3.5%). No difference was observed for low disease activity (RR = 0.83; 95% CI: 0.68, 1.03; I2= 71.3), serious and non-serious adverse events; disease activity scores; patient global assessment and radiographic progression.Conclusions:Preliminary results show no differences in clinically relevant outcomes from reduction of biologics compared to regular doses. As a limited number of studies is available, the certainty of evidence is limited and need to be monitored to better inform patients and clinicians.
OP112 Stakeholder Views As Evidence For NICE's Public Involvement Review
Authors: Thomas Lizzie , Livingstone Heidi , Kastoryano Chloe , Leng Gillian , Thomas Victoria 
Published: January 2019

Introduction:The National Institute for Health and Care Excellence (NICE) strategic review of its public involvement offer included a survey with stakeholders to explore how NICE can continue to deliver high quality, meaningful public involvement in a rapidly-changing environment.Methods:NICE staff, committee lay members, and an external academic ran the project and designed an online survey. The survey was open for two weeks. A purposive sample, recruited through various communication channels, was invited to participate. The sample comprised: (i) external individuals involved in NICE work, (ii) NICE committee and Board members, (iii) NICE staff. The survey included qualitative and quantitative questions, covering the ‘who’, ‘when’, ‘how’ and ‘what’ of NICE's public involvement approaches.Results:The survey yielded 684 responses, which were stratified by stakeholder type. Overall the responses indicated that: (i) the suggested stages for involvement are all important, but on a sliding scale: ‘defining outcomes guidance should consider’ is most important, and ‘helping committee chair recruitment’ is least important; (ii) different perspectives are needed such as individual treatment or care decisions should incorporate views of directly affected people, and population-based public health decisions need the views of citizens. Quality improvement suggestions included: (i) seeking feedback on people's experiences of care, using clear, structured approaches including focus groups, interviews, surveys, social media; (ii) increasing communications about NICE's work, specifically about involvement opportunities and use of patient evidence; (iii) using data on people's experiences equally with academic evidence; (iv) providing education and training on involvement to NICE staff and the general public; and, (v) partnership working with other organizations to enhance engagement. A focus group with key stakeholders used the survey findings to shape the subsequent public consultation document.Conclusions:There was consensus that public involvement is necessary throughout guidance development; however, the type of person involved and nature of participation should vary across the development stages. Project challenges included managing diametrically opposing views, and the associated implications for engagement.
OP120 Rapid Qualitative Reviews: A Scoping Review Of Guidance And Examples
Authors: Campbell Fiona , Weeks Laura , Booth Andrew , Kaunelis David , Smith Andrea 
Published: January 2019

Introduction:Decision-makers are increasingly recognizing the usefulness of qualitative research to inform patient-centered policy decisions, and are accordingly increasingly demanding qualitative evidence as part of health technology assessment (HTA). In the context of tight HTA timelines, a new form of evidence synthesis has emerged—rapid qualitative reviews. The need for rapidity requires either an increase in resources or, more commonly, a compromise in rigor, yet guidance on appropriate compromises for qualitative reviews is lacking.Methods:In order to inform de novo guidance, we conducted a systematic scoping review to identify existing guidance and published examples of rapid qualitative reviews. We searched Medline and CINAHL using medical subject headings and keywords related to “rapid reviews” and “qualitative” research, and screened the 1,771 resultant citations independently in duplicate. Additionally, we searched the grey literature and solicited examples from our contacts and other evidence-synthesis organizations. We summarized included guidance and reviews using the Search, AppraisaL, Synthesis, Analysis (SALSA) framework to identify abbreviations in the review process.Results:We found no guidance documents specific to rapid qualitative reviews. We found one published peer-reviewed rapid qualitative review, and several more (>10; grey literature search in process) through our organizational contacts. While methods to abbreviate the process are poorly reported, an abbreviated literature search (years and databases searched) and the use of a single reviewer appear common.Conclusions:A number of agencies are producing rapid qualitative reviews, however our review identifies the urgent need to develop and explore methods for the synthesis of qualitative research that balance rapidity and rigor.
OP136 Full Texts Versus Conference Abstract Data: How Does The Message Change?
Authors: Varley-Campbell Jo , Cooper Chris , Coelho Helen , Dodman Sophie , Barnish Max , Mujica-Mota Ruben , Hyde Christopher , Hoyle Martin 
Published: January 2019

Introduction:High quality evidence for test accuracy can be scarce. We assessed the test accuracy of two tests (Actim Partus and PartoSure) for the prediction of preterm birth. Twenty published full-text papers were included whilst conference abstracts were excluded. Since systematic reviews of diagnostic tests on other topics may need to rely on data from conference abstracts, we test whether the findings of our review would change with conference abstracts included.Methods:Conference citations previously excluded (n=108) were re-screened for inclusion using the following criteria: i) the diagnostic test was Actim Partus or PartoSure ii) test accuracy data of preterm delivery within seven days was reported iii) the population was women with signs/symptoms of preterm labor with intact membranes. Relevant test accuracy data were extracted and used to calculate sensitivity and specificity. Pooled sensitivity and specificity for each test were run using data from full-text papers and conference abstracts combined. These values were compared with the pooled sensitivities and specificities produced for the systematic review using full-text papers only.Results:Preliminary pooled sensitivities of the sixteen full-text Actim Partus studies and sixteen full-texts and two abstracts were 0.77 (95% confidence interval (CI) 0.68, 0.83) and 0.76 (95% CI 0.69, 0.83) respectively whilst pooled specificities were 0.81 (95% CI 0.76, 0.85).and 0.80 (95% CI 0.75, 0.84) respectively. Preliminary, pooled sensitivities of the four full-text PartoSure studies and four full-texts and three abstracts were 0.83 (95% CI 0.61, 0.94) and 0.82 (95% CI 0.65, 0.92), respectively, whilst pooled specificities were 0.95 (95% CI 0.89, 0.98) and 0.96 (95% CI 0.94, 0.97), respectively.Conclusions:Our findings suggest that the test accuracy results would not alter substantially with the inclusion of conference abstracts. However, work is ongoing to investigate how the assessment of heterogeneity and risk of bias across studies would alter given the difficulties associated with limited methodological reporting from conference abstracts.
OP152 Level Of Agreement In EUnetHTA Joint Action 3 Early Dialogues
Authors: Fernandez Judith , Guilhaume Chantal , Galbraith Margaret , Meyer François , Belorgey Chantal , Thuillez Christian , d'Andon Anne 
Published: January 2019

Introduction:A recent article reported a high level of commonality across European Health Technology Assessment bodies’ (HTABs) positions in former parallel scientific advice procedure. Since 2017, the EUnetHTA joint action 3 (JA3) offers a new early dialogue process involving a higher number of European HTABs. The present analysis aims to describe if the JA3 process modified the level of agreement across HTABs.Methods:A descriptive analysis of the written recommendations provided during every JA3 early dialogues coordinated by the French National Authority for Health (HAS) until November 2017 was conducted. The level of commonality for each HTAB position identified was assessed globally and by domain (population, comparator, outcomes, study design and health economics) and classified as follows: “full agreement” if all HTABs had the same position, “partial agreement” if more than half HTABs had the same position and “disagreement” in all other cases.Results:Four JA3 early dialogues were performed until November 2017: two in oncology, one in neurology and one in metabolic disorders. Between five and nine HTABs from eleven European countries participated. A total of forty-six positions were identified in these four early dialogues: ten on population, five on comparator, fifteen on outcomes, four on study design and twelve on health economics. Of the forty-six positions, full agreement was reached for twenty-eight positions, partial agreement for seventeen positions and only one disagreement was observed. The level of full agreements was highest for questions on comparators (five out of five) and population (nine out of ten) and lower for questions on health economics (six out of 12).Conclusions:Although the JA3 process substantially increased the number of HTABs participating in the early dialogues, this descriptive analysis suggests that the level of agreement remains very high. This may be facilitated by the high level of dialogue and coordination between HTAB ensured by the EUnetHTA process.
OP175 A National Perspective On Criteria And Methods For Resource Allocation
Authors: Roy Mathieu , Déry Véronique , Ganache Isabelle , Gagné Véronique , de Langavant Ghislaine Cleret 
Published: January 2019

Introduction:Decisions about which health and social services to include in the publicly funded services basket are complex. Several criteria need to be taken into account in decision-making (DM), as well as ethical, economic and organizational issues. Nowadays a global consensus supports the view that citizens’ values and preferences must guide DM. To elicit these values and concerns regarding publicly funded services, the Quebec Health and Welfare Commissioner recently conducted a vast public consultation on the population viewpoints. Parts of this consultation targeted criteria for DM, approaches to assess new or current services and perspectives on appropriateness of care.Methods:Various consultation methods were used in complementary steps: a representative population survey (n=1850), six regional focus groups (n=62), a call for briefs (n=52) for groups that wished to share their views, consultation meetings (n=35) with diverse stakeholders and a call for personal accounts (n=2633). It also held five deliberation sessions (18 citizens and 9 experts) over the course of the project on major related issues.Results:The need to ensure the appropriateness of covered services was one of the strongest themes emerging from the consultation. Citizens want that the appropriateness evaluation be carried out under certain conditions: transparently, in explicit DM processes, using criteria that are clear and adaptable according to the disease or problem. The whole evaluation process needs to be well documented, showing clearly the data used and rejected, so that they can understand the decision and see on what basis it is supported. Among the usual criteria for DM, those related to cost are less valued whereas others are considered incomplete.Conclusions:Citizens have clear viewpoints and expectations regarding DM criteria and processes for resource allocation. Decision-makers must take them into account to ensure that the basket of insured services is representative of social values and preferences.
PP05 Developing Equity In Remote Locations Through Telediagnosis
Authors: Galvan Pedro , Velazquez Miguel , Rivas Ronald , Benitez Gualberto , Ortellado Jose , Barrios Antonio , Hilario Enrique 
Published: January 2019

Introduction:Clinical background: Until recently, populations living in remote areas did not have access to specialist care and quality diagnostic services and thus depended on the low response capacity of their local health system. Subsequently, there were equity issues between urban and rural populations. Therefore it was considered telediagnosis applications should be directed towards developing better equity in the provision of services in remote locations without access to specialists. This study has evaluated the results of a new telemedicine system in remote public hospitals in Paraguay, in order to show how the response capacity of the local integrated health service delivery networks has been improved by providing access to tertiary level diagnostic services by specialists. Objective: This study aims to evaluate the utility of telemedicine as a tool for developing better equity in the provision of services in remote locations.Methods:This was a descriptive study, where the results of using telemedicine for diagnosis in remote public hospitals were evaluated as a tool to improve access to diagnostic services countrywide between 2014–2017. For these purposes, type and frequency of pathology diagnosed was determined.Results:A total of 311,562 telediagnoses were performed in fifty-seven hospitals. The 191,435 electrocardiogram diagnosis performed in the fifty-five hospitals were mainly normal (62.1%), unspecified arrhythmias (12.5%), and sinus bradycardia (10.4%). Also 115,924 teletomography tests were performed in twelve hospitals, where 54.4 percent corresponded to head as a consequence of accidents (motorcycles) and cerebrovascular diseases, 13.8 percent to chest, and the rest the other anatomical regions. Regarding the 4,184 electroencephalogram tests performed, antecedents of seizure (54.3%), evolutionary controls (14.0%), and headache (11.5%), were mainly diagnosed. The nineteen ultrasound studies corresponded to prenatal controls.Conclusions:Despite the results of the telediagnosis implemented in the public health to develop better equity in the provision of services in remote locations, a widespread use-assessment should be analyzed before this tool is adopted.