bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP71 Long-Term Evaluation Of Broad Mental Health Interventions: A Review
Authors: Canaway Alastair , Sampson Christopher , Meacock Rachel 
Published: January 2019

Introduction:Interventions and services for people with mental health problems can have broad remits: they are often designed to treat people with a variety of diagnoses. Furthermore, addressing mental health problems can have long-term implications for economic, social, and health outcomes. This represents a challenge for health technology assessment, for which long-term trial data can be lacking. In this review, we sought to identify how analysts have tackled this problem. We reviewed the methods used to extrapolate costs and outcomes for the purpose of economic evaluation where long-term trial data are not available.Methods:We conducted a systematic review of the medical and economic literature evaluating long-term costs and outcomes for mental health interventions and services designed to treat or prevent more than two mental health conditions. We searched key databases including MEDLINE, Embase, PsycINFO, CINAHL, and EconLit. Two authors independently screened citations. Articles were excluded if they reported within-trial analyses or employed a time horizon of less than 5 years.Results:The search identified 829 unique records. No papers could be included in the review.Conclusions:This review highlights the lack of research and understanding available to inform the appraisal of broad mental health interventions. In light of our findings, we consider the reasons for this lack of information and review relevant literature on the subject. Potential barriers to research in this context include: (i) challenges in understanding the value of broad mental health services, such as the mental and physical health nexus, intersectoral costs and benefits, and interpersonal impacts, (ii) methodological difficulties, such as data availability, patient heterogeneity, and the challenge of extrapolation, and (iii) parity of esteem. We make recommendations for resolving this problem with regard to funding, data collection, modelling methods, and outcome measurement.
PP88 Intravenous Medication Delivery System Cost-Effectiveness Analysis
Authors: Peregrino Antonio , Silva Roberto , Itria Alexander , Silva Carlos , Tolentino Ana , Marta Cristiano , Schutz Vivian , Scavarda Annibal , Oliveira Cristiane De 
Published: January 2019

Introduction:Medication delivery is one of the most common interventions in clinical practice. It requires the direct involvement of nurses and high precision infusion pumps in order to increase the infusion accuracy. Any mistake in the medication delivery process can lead to a medication error, resulting in adverse events with considerable increases in hospital length of stay and cost. Research studies should analyze this area more in emerging countries, as their realities differ from the realities of developed countries, where most of the literature of this area has been developed. This research study analyses this area in Brazil, a leading emerging country. The incorporation of these technologies in health services have caused two major problems: uncertainty around its effectiveness in reducing adverse drug event rates related to infusion dose errors, and the high cost of their inputs. The objective of this study was to analyze the cost-effectiveness of intelligent drug library infusion pumps to reduce adverse drug events during intravenous medication delivery in pediatric and neonatal patients.Methods:Cost-effectiveness was evaluated using a decision-tree framework, considering two scenarios as the base case: the reference one, which uses conventional infusion pumps for intravenous medication delivery with a volume greater than 60 mL, and an alternative one, which uses the drug library infusion pumps. The analysis is with the Unified Health System (Brazil's publicly funded health care system) perspective. The Monte Carlo simulations addressed the uncertainties of the framework. The effectiveness measure was avoidance of adverse drug events.Results:The probabilistic analysis showed the drug library infusion pumps to be more cost-effective than conventional pumps. This ratified what had already been revealed by acceptance curve, which demonstrated that the drug library infusion pumps are more likely to be cost-effective compared to the conventional infusion pumps (with a minimum of the incremental cost-effectiveness of USD 1,501.28).Conclusions:The study demonstrated that the use of the drug library infusion pumps in the pediatric and the neonatal intensive care unit can improve the results of the adverse drug event reduction strategy.
PP93 HTA Role In CoreHEM, A Multi-Stakeholder Core Outcome Set Project
Authors: Clearfield Elizabeth , Skinner Mark , Iorio Alfonso , Tunis Sean , Naber Jennifer Al , Messner Donna 
Published: January 2019

Introduction:Hemophilia gene therapy trials demonstrate a “cure” could be achievable, thereby changing disease management. CoreHEM aims to develop multi-stakeholder consensus around a clearly defined, core outcome set (COS) - a minimum set of outcomes that should be measured and reported in all clinical trials of a specific condition - that will demonstrate and allow differentiation of the effectiveness and value of gene therapy relative to the current standard of care. Health technology assessment (HTA) frequently suffers from a lack of relevant, consistently reported outcomes. When uniformly implemented, COS increase the predictability and consistency of appraisals, coverage, and reimbursement decisions by payers and HTA agencies.Methods:A COS was developed using a modified Delphi process, including online surveys and an in-person consensus meeting. A literature review and key informant interviews were used to create an initial list of outcomes for voting. Participants (patients, including representatives from the National Hemophilia Foundation and the World Federation of Hemophilia, healthcare providers, payers, HTA agencies, regulators and industry representatives) condensed and prioritized the list by rating each outcome on a scale of 1 (not important to include) to 9 (essential). Participants could also suggest outcomes for voting. Outcomes were eliminated from consideration if <70 percent rated the outcome from 7–9, unless the patient stakeholder group average score was ≥7.Results:After two Delphi rounds, there was consensus on three outcomes: frequency of bleeds, factor activity level, and duration of expression. Additional outcomes included after an in-person consensus meeting were chronic pain, mental health status, and utilization of the healthcare system (direct costs). Adverse events of interest were evaluated and separately reported.Conclusions:Including the coreHEM COS in clinical development programs will ensure that relevant, consistent outcomes are available for decisions by HTA agencies, clinicians, and patients. This should result in faster access to novel, high-value therapies for appropriate patients.
PP108 Novel Approaches For Fair And Reasonable Value-Based Recommendations
Authors: Plamondon Geneviève , Auclair Yannick , de Guise Michèle , Beha Sara , Arbour Sylvie , Goetghebeur Mireille , Jobin Nathalie , Nieminen Julie 
Published: January 2019

Introduction:Stakeholders from the innovation field in Québec (Canada) have collectively stressed the need to formalize the process for evaluating innovative technologies in the province. In the context of innovation, and more so for non-pharmaceutical technologies where the pace of development is rapid and the lifecycle short, evidence supporting the added value can be limited and uncertainties are common. Therefore, pragmatic approaches are needed to guide recommendations and to assure that the process is rigorous, transparent and fair.Methods:Inspired by international experiences, the Institut national d'excellence en santé et services sociaux (INESSS) has developed a novel framework, where four types of recommendations are possible (introduction, refusal, limited or conditional introduction). The starting point is an evaluation of the technology's added value, for the patient, the population and the healthcare system, and the identification of uncertainties. The value of addressing uncertainty with further research is assessed, based on the value-of-information theory, and the distinct characteristics of medical devices are taken into account (e.g. learning curve effect, irrecoverable costs and incremental innovation). Those elements interact to support the formulation of recommendations by INESSS’ advisory committee.Results:The development of the framework was an iterative process supported by the use of the preliminary framework for the assessment of several innovative technologies. Challenges with its use were identified, and led to methodological and operational improvements. So far, the experience with the framework is positive and stakeholders confirm its relevance to support fair and reasonable recommendations for innovations.Conclusions:In the rapidly changing landscape of innovation, HTA has to adapt to the challenges of assessing technologies in a context of promise and uncertainties. The framework developed by INESSS is a tool for supporting timely and fair value-based decision-making, which will benefit the healthcare system, and the patients and population it serves.
PP111 Toward Healthy Coagulation In Hemophilia
Authors: Dolan Gerry , Berntorp Erik , Nugent Diane , Skinner Mark 
Published: January 2019

Introduction:Healthcare advances in hemophilia have led to near-normal life expectancies in a disorder previously associated with early death. Unlike other disorders where the therapeutic goal is to restore deficiencies to normal levels, prophylaxis in hemophilia is used to achieve a plasma level of FVIII >1%, such that severe hemophilia may be reduced to a moderate/mild phenotype. With the development of new therapies, treatment goals are evolving from on-demand treatment or prevention of bleeds to one where the risk of bleeding is minimal/absent. To accelerate this development, a new treatment paradigm is needed, with consensus from key stakeholder communities, to facilitate a shared vision for the future of hemophilia healthcare.Methods:A panel of hemophilia providers, patient advocates, and industry representatives convened to develop a new treatment model that establishes specific treatment milestones and target outcomes in a stepwise fashion, culminating in a progressive definition of cure.Results:To represent the collective experience of hemophilia for patients and treaters around the world, the following treatment milestones were defined based on optimized outcomes: (i) Sustain Life – prevention of premature death; (ii) Minimal Joint Impairment – improved quality of life; participation in activities of daily living; (iii) Freedom From Spontaneous Bleeds – ability to engage in low-risk activities; (iv) Attainment of ‘Normal’ Mobility – participation in work, career, and family life without restriction; (v) Able to Sustain Minor Trauma – more unrestricted lifestyle; (vi) Ability to Sustain Major Surgery or Trauma Without Additional Intervention – no dependency on specialized healthcare; (vii) Normal Hemostasis – optimal health and well-being; and (viii) Cure – health equity.Conclusions:With milestones for disease management leading toward normalized hemostasis, this treatment model provides a vision to improve hemophilia care for all patients. And by providing achievable outcomes, the community—patients, treaters, and their industry partners—has a clear path to achieve that goal.
PP114 Clinical Effectiveness Of Insulin Glargine; Findings And Implications
Authors: Marra Lays , Guerra Augusto , Araújo Vânia , Oliveira Gerusa , Diniz Leonardo , Acurcio Francisco , Godman Brian , Alvares Juliana 
Published: January 2019

Introduction:There is continuing controversy surrounding the funding of insulin glargine versus neutral protamine Hagedorn (NPH) insulin in Brazil, due to substantial differences in their prices, and recent meta-analyses of randomized controlled trials and independent observational studies that show no difference in effectiveness; however, sponsored observational studies show greater effectiveness of insulin glargine. Overall, the cost-effectiveness of insulin glargine in Brazil is controversial. In view of the continuing controversy, there is a need to address this using patient level data within the public health system in Brazil.Methods:We conducted a retrospective historical cohort study of type 1diabetes patients receiving insulin glargine from January 2011 to January 2015, including patients in the public health system in Minas Gerais. Variables included (i) demographic variables, (ii) clinical variables e.g. time with a diagnosis of type 1 diabetes, (iii) treatment characteristics, and (iv) laboratory results of HbA1c. Individuals were compared with themselves in an analysis of HbA1c values before and after six months of using insulin glargine, with each patient acting as their own control.Results:Five hundred and eighty patients were included in the study. HbA1c varied from 8.80±1.98 percent in NPH insulin users to 8.54±1.88 percent after insulin glargine for six months, which is not clinically significant. The frequency of glycemic control varied from 22.6 percent with NPH insulin to 26.2 percent with insulin glargine. No statistically significant difference was observed between groups for all analyzed factors, including type and frequency of insulin use and carbohydrate counting.Conclusions:There were limited differences between NPH insulins and insulin analogues in this real world study. As a result, the continued appreciable cost difference in between insulin glargine and NPH insulin in Brazil cannot be justified.
PP137 Colorectal Cancer Screening In The Philippines: Cost-Utility Analysis
Authors: Wong John , Co Stephanie Anne , Bagas Joy , Reyes Ma. Sophia Graciela , Lim Hadrian , Haw Nel Jason 
Published: January 2019

Introduction:Colorectal cancer (CRC) is the fourth leading cause of cancer deaths in the Philippines. In 2014, the Philippine Health Insurance Corporation (PhilHealth) created a CRC treatment package. The study aimed to determine the cost-utility and budget impact of CRC screening strategies.Methods:A discrete-event microsimulation model was used to simulate four screening modalities: (i) guaiac-fecal occult blood test (gFOBT) followed by colonoscopy every 10 years; (ii) fecal immunochemical test (FIT) followed by colonoscopy every 10 years; (iii) FIT followed by flexible sigmoidoscopy; and (iv) colonoscopy screening every 10 years. These interventions were all compared to no screening. Parameter values were taken from a rapid review of the medical literature and primary data collection from a nationally representative sample of tertiary hospitals.Results:All screening modalities were very cost effective considering that the incremental cost-effective ratios (ICERs) were lower than the gross domestic product per capita threshold suggested by the World Health Organization. Sensitivity analysis showed that the ICERs of all screening modalities evaluated remained below this threshold. The strategy of using FIT followed by colonoscopy every 10 years had an ICER of USD 6,025, with an annual budget impact of USD 6.5 million, assuming low compliance. With moderate compliance this could increase to USD 18.7 million annually.Conclusions:PhilHealth may introduce a benefit package for outpatient screening of colorectal cancer using the screening modality of annual FIT followed by colonoscopy every 10 years.
PP142 Is Insulin Therapy Important For The Quality Of Life Of Diabetics?
Authors: Almeida Paulo Henrique Ribeiro Fernandes , Silva Thales Brendon Castano , de Lemos Lívia Lovato Pires , de Assis Acúrcio Francisco , Júnior Augusto Afonso Guerra , de Araújo Vânia Eloísa , Diniz Leonardo Mauricio , Godman Brian , Bennie Marion , Almeida Alessandra Maciel , Álvares Juliana 
Published: January 2019

Introduction:Quality of life (QoL) is an important health measure and is widely used to assess the difference between treatments for Type 1 Diabetes Mellitus (T1DM) since the desirable glycemic control and the minimization of episodes of hypoglycemia are fundamental aspects for a better QoL. This study aims to identify the factors associated with QoL in patients with T1DM.Methods:A cross-sectional study (approved by ethics committee) was carried out in the state of Minas Gerais with 401 T1DM patients who used insulin glargine (GLA) selected in March 2017, and 179 patients who used insulin-neutral protamine (NPH) selected between January and February 2014, and both groups were treated by Brazilian National Health System (SUS). A questionnaire with three blocks was used: A) sociodemographic data; B) clinical data and access to the service; and C) QoL by Euroqol (EQ-5D-3L). We used multiple linear regression model by the forward stepwise method to access the correlation between the utilities of the EQ-5D-3L and all the explanatory variables (blocks A and B). We adopted the significance level and confidence interval of 95 percent (95% CI).Results:Of the 580 patients evaluated, 54 percent were women, 47 percent were in the age group between 18–40 years, 53 percent reported to be non-black. The EQ-5D-3L analysis showed patients treated with insulin analogue GLA had an average utility of 0.849 and those treated with NPH insulin 0.722 (p < 0.000). Individuals young, very good/good health self-perception, having not been bedridden in the last 15 days, zero to three medical appointments in the last year, no hospitalization in the last year, regular physical activity in the last 15 days to practice physical exercise, having between zero and three comorbidities and no severe hypoglycemia in the last 30 days were explained 41.3 percent of QoL. The type of insulin therapy, GLA or NPH, did not enter into the final multiple regression model.Conclusions:The findings of this study pointed to a lack of correlation between insulin therapy and QoL of patients with T1DM. Sociodemographic and clinical factors were more important to explain the QoL of diabetics. In addition, the evidence pointed to the importance of episodes of hypoglycemia for Qol. Of the 191 episodes of hypoglycemia (non-severe and severe) reported, 66 percent were from patients treated with GLA.
PP145 Using Health Technology Assessment To Drive Guideline Development
Authors: Scott Ann , Moga Carmen , Harstall Christa 
Published: January 2019

Introduction:Clinical practice guidelines (CPGs) are a key vehicle for converting evidence into action. CPGs can be produced by various methods: de novo, adaptation, adoption, or a combination of these. Deciding whether and how to develop a guideline can be challenging. Health technology assessment (HTA) researchers from the Institute of Health Economics developed a multi-step decisional algorithm highlighting the decision nodes in the initial phase of guideline development where HTA products and expertise can be valuable in demystifying these decisions.Methods:A literature search was conducted for articles comparing methods of developing CPGs, with particular focus on finding a priori criteria for deciding when to use one method versus another.Results:The published literature is sparse and there are no specific criteria available for deciding when to use one method of development versus another. The proposed multi-step algorithm identifies similar steps in the production of all types of CPGs: the set-up phase; establishing the need for a new CPG in consultation with a guideline development group and local stakeholders; developing research question(s); conducting searches for suitable existing guidelines; and finalizing the guideline. HTA can help set the health question(s) and identify and screen existing CPGs. When CPGs are not available, HTA methods are implemented to update the evidence in a blend of de novo and adaptation processes by reviewing umbrella reviews, systematic reviews, and primary studies. Quality appraisal of existing guidelines and syntheses of evidence in a rapid review fashion help determine whether there are enough studies to support the guideline scope.Conclusions:Deciding which method of guideline development to employ requires ample methodological expertise, an intimate knowledge of the clinical practice environment, and access to detailed contextual information. The proposed multi-step algorithm shows how to successfully leverage HTA resources to support CPG production and move research evidence into practice.
PD42 Safety And Cost-Effectiveness Of Platelet-Rich Plasma For Chronic Wounds
Authors: del Pino-Sedeño Tasmania , Linertová Renata , Trujillo-Martin Maria M. , Toledo-Chávarri Ana , Girardot Sybille Káiser , De Pascual Ana M. , Andia Isabel , Sánchez Javier Aragón , Huerta Dolores Rodríguez , León-Salas Beatriz , Herrera-Ramos Estefanía 
Published: January 2019

Introduction:New therapeutic strategies have been established in chronic wound healing procedures, such as the use of platelet-rich plasma (PRP). There is currently still uncertainty about the effectiveness, cost-effectiveness and real safety of PRP in promoting chronic wound healing and what specific types of chronic wounds can benefit most from its use.Methods:We conducted a systematic review of available scientific literature on the effectiveness, safety and cost-effectiveness of PRP compared to placebo, standard care or alternative topical therapies for the treatment of chronic wounds in adults. Overall effect size was estimated through a meta-analysis. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals for a 5-year horizon, from the perspective of the Spanish National Health Service (NHS) for the PRP versus standard treatment in patients with diabetic foot ulcers. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.Results:Sixteen RCTs and four observational studies were included for the effectiveness and safety meta-analysis. The primary outcome was the proportion of chronic wounds completely healed: 143 patients out of 334 (42.8 percent) were cured in the standard treatment arm and 251 patients out of 375 (66.9 percent) in the PRP arm, relative risk (RR) 1.68 (95% CI: 1.22–2.31). It was unclear whether there was a difference in the risk of infection (RR 0.53, 95% CI: 0.10–2.71) or adverse events (RR 1.05, 95% CI: 0.29–3.88) between PRP and standard care. Three studies were considered for the cost-effectiveness analysis. In the base case analysis, PRP led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio (ICER) of EUR 41,767 (USD 48,323)/QALY.Conclusions:PRP treatment is more expensive and more effective than standard treatment. The estimated ICER is above the acceptability threshold in Spain.