bluuebunny/crossref_metadata_2025_split huggingface dataset:
VP111 Referral Center For Multiple Myeloma Patient Care
Authors: Saccilotto Indara , Bittencourt Rosane , Fischer Camila , Quevedo Amanda , Hirakata Vania , Picon Paulo 
Published: January 2018

INTRODUCTION:Within the Brazilian Health System, Referral Centers (RCs) are care facilities that provide specialized services. The objective of this study was to evaluate the efficacy of care provided to patients with multiple myeloma (MM) at a specialized Referral Centers (Hospital de Clínicas de Porto Alegre Referral Center for Multiple Myeloma, CRMM-HCPA) and to compare quality of life between patients with MM treated at CRMM-HCPA and those treated at non-RC facilities.METHODS:A 6-month cohort study was conducted in patients with MM receiving thalidomide from the State Health Department and treated at CRMM-HCPA, and patients receiving treatment at other non-RC facilities. Thirty-two patients were included in the study, nineteen from CRMM-HCPA and thirteen from other institutions. To analyze the efficacy of care provided at CRMM-HCPA, the main outcome measure was the time from diagnosis to referral for autologous hematopoietic stem cell transplantation.This outcome measure was assessed using questionnaires specifically designed for this study. Quality of life was also assessed, using the Short-Form 36 Item Health Survey (SF-36) questionnaire.RESULTS:Time from MM diagnosis to referral for autologous hematopoietic stem cell transplantation in each group was measured only in patients aged 65 years (n = 25); of these, 15 were recruited from CRMM-HCPA and 10 from other institutions. In this analysis, there was a significant difference (p = .036) in time elapsed between diagnosis and referral for autologous hematopoietic stem cell transplantation, which was significantly shorter for patients treated at CRMM-HCPA (median, 9 months; Interquartile Range, IQR, 8.5–14.5) than for those treated elsewhere (median, 24 months; IQR, 16–24). On quality of life analysis, there was a significant difference in the Social Functioning, which relates to performance of social activities (p = .02).CONCLUSIONS:The Referral Centers model provided seems to be a more efficient treatment strategy as compared with other health care facilities, as it enabled a reduction in time to transplantation. Patients treated at CRMM-HCPA demonstrated greater ease in performing social activities, with less interference from physical or emotional problems.
VP133 Patient-Reported Health State Utilities In Neuroendocrine Tumours
Authors: Meng Yang , McCarthy Grant , Berthon Anthony , Dinet Jerome 
Published: January 2018

INTRODUCTION:Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are rare cancers most often found in the gastrointestinal system or the pancreas. However, patient-reported health state utilities based on clinical trials have not been previously reported in this disease area.METHODS:The CLARINET study collected the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 data from patients in both stable and progressive disease states, although data for the latter were only available during the early stage of progression due to trial design. Using published algorithms, data were mapped to EQ-5D utility values. Random-effects generalized least squares models were used to investigate the impacts of progression status, tumour site and other patient characteristics on mapped utility values.RESULTS:In total, 1,053 observations from 204 patients were mapped to EuroQol (EQ-5D) utilities using the McKenzie mapping algorithm. The final random-effects model included age, gender, baseline utility and progression status as covariates; it was not feasible to investigate time-to-death utility due to a limited number of death in the CLARINET study. Tumour location (midgut versus pancreas) does not seem to affect utility. However, the difference in utilities based on progression status is statistically significant (p<.05) in the base case analysis, and the estimated utilities for stable and progressive disease are .776 and .726, respectively. Furthermore, scenario analyses showed that utility for progressive disease is numerically lower than for stable disease, but this may not be statistically significant in some scenarios.CONCLUSIONS:Patients with GEP-NETs experience worse utility values in the progressive disease state compared to the stable disease state, based on patient-reported health-related quality of life (HRQL) data from the CLARINET study. The decline of utility in the progressive disease state may be underestimated because progressive HRQL data were only collected shortly after the progression event in the trial. The estimated trial-based utilities can be used in future economic evaluations for GEP-NET treatments and to provide more insights to physicians on patient-reported quality of life outcomes in GEP-NETs.
VP137 Why We Should Not Meet Unmet Needs!
Authors: Sandman Lars 
Published: January 2018

INTRODUCTION:In formulating criteria for Health Technology Assessment (HTA) and priority setting a number of such criteria have been suggested and are used, for example in multi-criteria decision making. Besides taking central aspects like severity of disease, effectiveness, cost-effectiveness and patient safety into account, we also find references to criteria like unmet needs, and lack of alternative treatment. Often these criteria are treated as on par with each other, only given different weights in decision making. However, it seems like there is a conceptual overlap between some of these criteria and if that remains unnoticed, there is a risk of taking the same criteria into account twice. One such example is the relationship between severity of disease and unmet need. The aim of this presentation is to present a tentative analysis of the relationship between severity of disease and unmet need.METHODS:The presentation is based on a conceptual and normative analysis.RESULTS:First it will be argued that we have reason to clarify what is meant by unmet needs, whether it is a need which is not met to any degree or if it is a need for which there is no treatment with curative intent or for which there is only palliative treatment, for example. Second, analyzing unmet needs in relation to severity, a number of different scenarios will be examined, showing that unmet needs can be captured in terms of severity of disease (to some extent dependent upon how we operationalize severity of disease).CONCLUSIONS:The general conclusion of the study is that we have reason to carefully analyze criteria used for decision making in HTA from a conceptual and normative perspective in order to uncover logical relationships and avoid overlapping criteria. In relation to the specific question of unmet needs versus severity of disease, the conclusion is that in most cases unmet need will be redudant in relation to severity and we should be careful using both of them in decision making unless we can provide reasons for why it is an exceptional case.
VP148 Health Technology Assessment Of Femtosecond Laser: A New Frontier In Cataract Surgery
Authors: Faggiano Francesco , Andellini Martina , Sabusco Francesca , Derrico Pietro , Ritrovato Matteo 
Published: January 2018

INTRODUCTION:Cataract surgery is one of the most frequent ophthalmological surgical procedures performed in children. However, clinical outcomes in younger patients are generally unpredictable. Currently, cataract surgery can be performed through the traditional phacoemulsification ultrasound probe or Femtosecond Laser (1). The aim of this study is to describe the application of Decision-oriented Health Technology Assessment (HTA) (DoHTA) to assess the femtosecond laser-assisted cataract surgery (FLACS) compared to conventional cataract surgery (CCS).METHODS:To evaluate safety, costs, organizational aspects, effectiveness and technical characteristics of FLACS compared with CCS, a DoHTA method was applied (2). DoHTA is a new implementation of the European Network For HTA (EUnetHTA) Core Model®, which integrates the Multi-Criteria Decision Analysis (MCDA) using the Analytic Hierarchy Process (AHP). All the relevant assessment aspects of FLACS are summarized in a hierarchical decision tree by means of Key Performance Indicators (KPI), subsequently weighted through pairwise comparisons. Lastly, FLACS and CCS were ranked against lowest indicators of decision tree.RESULTS:The multidisciplinary assessment took into consideration all the aspects and recommendations about the benefits and disadvantages of FLACS compared to CCS. DoHTA results showed that FLACS surgery is safe and effective for pediatric patients. Furthermore, FLACS seems to overcome CCS with several important developments such as increased precision of anterior capsulotomy, reduced ultrasound power requirement during phacoemulsification, decreased collateral tissue damage, increased accuracy and consistency in surgical results as well as better visual outcomes. Notwithstanding such clinical improvements, FLACS is more expensive than its comparator.CONCLUSIONS:The DoHTA results integrated the evidence from the scientific literature (which is still limited) with experts judgments. Indeed, although FLACS had the highest purchase price, DoHTA results showed that FL improves the quality of cataract surgery. Based on our results and taking into consideration the positive safety and clinical effectiveness features, we conclude that FLACS may be a good alternative to CCS.
VP155 Synchronization Of Regulatory Approval And Health Technology Assessment Recommendation Timing
Authors: McAuslane Neil , Wang Tina , Liberti Lawrence 
Published: January 2018

INTRODUCTION:Minimizing the delay between regulatory approval and Health Technology Assessment (HTA) recommendation is critical to ensure patients access to medicines of therapeutic value. The aim of this study was to evaluate the level of synchronization between the regulatory decision and HTA recommendation.METHODS:Data were collected from the public domain for new active substances that were first appraised by the HTA agency in Scotland (SMC - Scottish Medicines Consortium), France (HAS - Haute Autorité de Santé), Germany (IQWIG - Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), Australia (PBAC - Pharmaceutical Benefits Advisory Committee) and Canada (CADTH - Canadian Agency for Drugs and Technologies), and that reached an outcome in 2014 and 2015. The year the product was approved by the European Medicines Agency (EMA), Australian Therapeutic Goods Administration (TGA) and Health Canada were also assessed.RESULTS:In 2014 and 2015, fifty-one products with HTA recommendations were identified for SMC and IQWIG, forty-two for HAS, forty for PBAC and thirty-eight for CADTH.Of the HTA agencies studied, CADTH had the lowest percentage of HTA recommendations occurring the same year as jurisdictional regulatory approval. Of the products with CADTH recommendations in 2014, only 7 percent were approved by Health Canada in the same year. By comparison, all of the products with PBAC recommendations in 2015 were approved by TGA in the same year.For 2014 and 2015, comparing the percentage of HTA recommendations with the jurisdictional regulatory agency approval the same year showed 7 percent (2014) versus 29 percent (2015) for CADTH: 35 percent versus 37 percent for SMC: 35 percent versus 44 percent for HAS; 56 percent versus 57 percent for IQWIG; and 91 percent versus 100 percent for PBAC.CONCLUSIONS:This study shows that the parallel submission mechanism to enable synchronizing HTA and regulatory decision making is effective in Australia, whilst there remains a synchronization disconnect in other countries; although this may be improving. The extent of decision timing disconnect, influence of company strategy and type of HTA outcome were also studied. This initial analysis suggests gaps between the timing of regulatory approval and HTA recommendation for HTA agencies outside of Australia.
VP159 Strengthening Primary Health Care In Nigeria By Patient Involvement
Authors: Adeyemi Sylvester , Ekpenyong Aniekan 
Published: January 2018

INTRODUCTION:The Health system in Nigeria is structured into three tiers which include tertiary health care, secondary health care and primary health care (PHC). The latter forms the grassroots system of delivering basic health services to communities in both rural and urban centers. However PHC in Nigeria have been affected by poor service delivery. This has resulted in underuse of PHC due to the acceptance and utilization of health services delivered through this system. This research seek to bridge the gap of inequality, reaffirm that implementing PHC is a human right/duty and fosters patient and consumer involvement for economic, social and environmental sustainability of PHC.METHODS:A qualitative method of research was adopted using a participatory research model. The relative data was sourced secondarily from recent findings (July 2015) carried out in seventy-three primary health centers across Anambra State, Benue State, Kaduna State, Plateau State and Federal Capital Territory (FCT) of Nigeria. Issues that were examined included: client perspective and community involvement, status of available services, utilization and service delivery, and infrastructure and human resource capacities. The respondent of 294 client/service user population from interview were recorded and analyzed.RESULTS:The assessment showed client dissatisfaction to services being provided. In most centers, National Primary Health Care Development Agency (NPHCDA) requirements like availability of basic functional equipment, well trained health workers, patient record system, and access to water and sanitation were not met. Most of the facilities visited reported to be disconnected from the health system due to supportive supervision.CONCLUSIONS:Conclusively, the interest of the underserved Nigerian could be advocated for through local committees of consumer organizations. Their involvement will have an impact in PHC evaluation, policy making, and implementation of action plans aimed at improving PHC services.
VP168 Assessment Of Plasmapheresis For Alzheimer's Disease Systematic Review
Authors: Luengo-Matos Setefilla , Polo-Desantos Mar , Sanchez-Gomez Luis Maria , Orrego Juan Pablo Chalco 
Published: January 2018

INTRODUCTION:Alzheimer's disease (AD) is the most common type of dementia. Plasmapheresis is a procedure consisting of removing the plasma, or specific elements which are considered to be involved in pathological processes. Plasmapheresis could reduce the A beta peptides load in the brain. The objective is to study the safety and efficacy of plasmapheresis for AD.METHODS:Systematic review, with all studies published before April 2016 reviewed. Selected studies included patients with AD treated with plasmapheresis. GRADE was used to assess quality. Efficacy outcomes include: (i) Cognitive, functional and behavior status, through Mini Mental State Examination, and Alzheimer Disease Assessment Scale-Cognitive test; (ii) Plasma and cerebrospinal fluid A beta levels; (iii) Brain-imaging and functional neuroimaging studies. Safety outcomes included side effects related to the treatment.RESULTS:Two papers reporting results from three studies were selected: (i) pilot study (n = 10), (ii) its extended study (12 months more of follow-up) (n = 7), and (iii) clinical trial (n = 39). The quality of evidence was very low. About efficacy, the studies didn't report quantitative results and were inconclusive. The pilot study and its extended study reported (1): a tendency towards stabilization in cognitive status; the plasma levels of A beta peptides didn't show a clear pattern; and the brain-imaging assessment suggested a progressive volume increase in the hippocampus. The clinical trial reported in the experimental group vs control (2): a better score for the cognitive status; an increase of plasma A beta peptides; and did not find significant differences between groups for cerebrospinal fluid A beta peptides. The brain-imaging assessment showed a progressive loss of hippocampus volume in both groups. Regarding safety, the studies didn't report quantitative data. We didn't find economic evaluation studies.CONCLUSIONS:The included studies had very high risk of bias and very low quality. We found no evidence on efficacy and safety of plasmapheresis treating AD. Plasmapheresis isn't a priority line in research of AD treatment.
VP174 Atlases Of Quality: Assessing Integrated Care In Chronic Diseases
Authors: Robles Noemi , Ortiz Laura Muñoz , Espallargues Mireia 
Published: January 2018

INTRODUCTION:The Comprehensive Public Healthcare System of Catalonia (SISCAT) Atlases of Quality aim to evaluate the quality of care in relation to specific diseases or procedures in the Catalan territory with a focus on outcomes of care in order to promote best practices. The first Atlas of Quality aimed to assess the quality of integrated care for chronic patients.METHODS:Methodology was articulated in four stages:(i) Establishment of a conceptual framework of reference specific for each intervention/technology being assessed, (ii) Definition and consensus of the assessment indicators, and (iii) Implementation of indicators using the Basic Health Areas (ABS) of Catalonia as a unit of analysis, comparing ABS with vs without the intervention (such as integrated care for chronicity). Indicators were obtained from the SISCAT databases and implemented through risk adjustment models. For performance assessment, we calculated the observed and expected indicator rates for each ABS, and for the benchmarking analysis, these ratios were represented in funnel plots (Confidence Interval, CI 95 percent and 99.8 percent for exclusion zones). (iv) Evaluation of the intervention and identification of specific success factors.RESULTS:For the assessment of integrated care interventions for chronicity, the defined framework in stage 1 was base on the Kaiser Pyramid (population distribution), and the Porter and the Donabedian's approaches (structure, processes, outcomes) (1). In stage 2 more than 500 experts, using several qualitative techniques, considered 18 indicators as relevants and feasibles for the assessment (2). Ten of them were implemented in stage 3 for congestive heart failure and pulmonary obstructive chronic disease. Significant values were found both in ABS with and without chronicity care programms (phase 3).CONCLUSIONS:The subsequent analysis (phase 4) will allow identification of practices of each ABS that best explain these results. Some limitations must be considered such as the availability of the consensued indicators in the SISCAT databases.
VP176 Effectiveness Of Anti-Tumor Necrosis Factor In Patients With Psoriatic Arthritis
Authors: da Silva Michael , dos Santos Jéssica , Almeida Alessandra , Alvares Juliana , Guerra Augusto , Oliveira Haliton , Rodrigues Flávia , Bennie Marion , Godman Brian , Acurcio Francisco 
Published: January 2018

INTRODUCTION:Anti-tumor necrosis factor drugs (anti-TNF) are the last line of treatment for psoriatic arthritis (PsA) in the guideline of Brazilian Public Health System (SUS). Data of effectiveness of these drugs are scarce in the Latin American population. This study evaluated the effectiveness of the anti-TNF on a cohort of patients with PA in the SUS.METHODS:PsA patients treated with anti-TNF, were included in an open prospective cohort study. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI) were used to assess the effectiveness at six months of follow-up. The anti-TNF was considered effective when the patient achieves scores of four or less measured for BASDAI or scores of ten or less for CDAI. Frequency distributions were compiled for the sociodemographic variables and mean and standard deviation (SD) was used for clinical variables. The paired Student t-test was established to evaluate the differences between baseline and 6 months evaluated for BASDAI and CDAI.RESULTS:Fifty-four patients with PsA completed six months of follow-up. The mean age of patients was 54.03 years (10.44) and the mean disease duration was 8.00 years (7.49). Furthermore, 50 percent of the patients were female, 61.1 percent white and 59.6 percent married. The most used anti-TNF was adalimumab (63.0 percent), followed by etanercept (20.4 percent) and infliximab (16.7 percent). The anti-TNF reduced disease activity measured by BASDAI and CDAI at six months of follow-up (p<.001). The percentage of patients achieving the effectiveness with anti-TNF was 61.1 percent measured by BASDAI and 53.7 percent by CDAI.CONCLUSIONS:Anti-TNF drugs demonstrated to be effective in more than half of patients at six months. This result highlighted the importance of the treatment with the anti-TNF drugs in the Brazilian population. Long-term data are needed to confirm these results.
VP198 Efficient Retrieval Of Trial Protocols: An Empirical Study
Authors: Sutton Anthea , de la Cruz Maria del Carmen Galvan , Booth Andrew , Leaviss Joanna 
Published: January 2018

INTRODUCTION:Registration of trial protocols has become increasingly important in recent years. In the context of systematic reviews, published trial protocols facilitate the identification of studies. Data recorded in trials registers requires standardization to assist with ease of identification, and availability of the most current protocol version. Searching sources of trial protocols, for example trials registers, has issues relating to currency, coverage, functionality and indexing. An empirical study was conducted in the context of a funded systematic review, to establish; the proportion of trial protocols retrievable, the most effective retrieval methods, barriers to retrieving protocols, and whether the most easily retrieved protocol copy remains the document of record.METHODS:In a systematic review of primary care interventions for medically unexplained symptoms, seventy-four trials were identified as potential included studies. To search for the seventy-four trial protocols, multiple sources and methods were utilized to identify the the differential coverage of sources and the relative efficiency of retrieval methods. Retrieval methods included searching trials registers and bibliographic databases, internet searching, checking journal websites and contacting authors.RESULTS:Results included; (i) number of trial protocols that were referenced in the corresponding study publication(s), (ii) percentage of protocols indexed in each checked source, including MEDLINE and various trials registers, (iii) number of authors that responded to email contact, (iv) number of authors that provided a reference to, or copy of, the protocol. Information on when the trial protocol was published, funding sources, and trial registration, was also recorded.CONCLUSIONS:Conclusions are made regarding the coverage of different sources of trial protocols. This will enable Information Specialists to prioritize retrieval methods for identifying trial protocols to inform future search methods guidance. The main barriers to retrieving protocols are discussed together with recommendations for future empirical studies.