bluuebunny/crossref_metadata_2025_split huggingface dataset:
OP126 Shared Decision-Making Influences Patients’ Adoption Of Stents In China
Authors: Ming Jian , Wei Yan , Chen Yingyao , Huang Jiayan 
Published: January 2019

Introduction:Shared decision-making (SDM) is an essential component of patient-centered care, involving communication and discussions between physicians and patients on various options to meet their health needs. This study examines the current situation of patients’ participation in decision-making in relation to the clinical application of drug-eluting stents (DES). Further, the impact of patients’ involvement in decision-making on patients' adoption of DES was analyzed, with a view to providing research outcomes to guide clinical practice.Methods:A cross-sectional study was conducted from July to December 2016 in selected hospitals in Fujian Province, Sichuan Province, and Shanghai in China. Patients with coronary heart disease completed a survey, which contained the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) about satisfaction with decision-making processes, and questions on DES. Data were analyzed with cluster analysis, correlation analysis, multivariate logistic regression, and multivariate linear regression.Results:One hundred and seventy-nine patients with coronary heart disease from 15 hospitals in the three regions completed the questionnaire. There were good validity and reliability for SDM-Q-9, with Cronbach's alpha as 0.96 and intra-class correlations 0.59–0.79 (all P < 0.01). Among these respondents, 42.1 percent adopted DES, 83.4 percent were supportive of SDM and 61.33 percent thought they had better communication with physicians regarding decision-making. Patients’ level of SDM involvement was found to be positively associated with their satisfaction with the decision-making process (P < 0.001) and their adoption of DES (P < 0.05). Also, satisfaction with shared decision-making regarding treatment was positively associated with adoption of DES (P < 0.001).Conclusions:Most of the patients with coronary heart disease preferred SDM, and SDM was found to be an important predictor of patients’ satisfaction with decision-making processes and adoption of DES. Better communication between physicians and patients is needed in order to improve patients’ satisfaction and promote the appropriate use of DES technology in China.
OP139 Not Using Data From ‘Failed’ Primary Research Undermines Health Technology Assessment Reporting
Authors: Cook Andrew 
Published: January 2019

Introduction:The reliability of health technology assessment (HTA) is built on accessing evidence systematically to inform conclusions and recommendations; however, the availability of primary evidence is a source of bias which can undermine an HTA. This omission is often because attempts to generate primary evidence have not been completely successful. Where partial evidence exists, ignoring it constitutes avoidable bias. Taking the Hip Op trial as an example (a study of developmental dysplasia of the hip (DDH)) we consider how despite lack of quantitative outcomes data, rich information was obtained that should inform HTA in this area.Methods:The Hip Op trial was an open label trial comparing early against late surgery in the management of DDH. In parallel, a qualitative study attempted to explore the experience of parents of children with DDH.Results:The trial protocol called for recruitment of 636 children, but due to changes in clinician equipoise and service configuration only 29 could be recruited. The trial was stopped early. While baseline data for the 29 children was available, no estimate of effect was attempted due to a lack of outcome data; however, the qualitative data was rich, representing the biggest qualitative sample worldwide on this topic. It reflected the patient experience, and shows a clear preference towards early intervention, despite the absence of quantitative evidence.Conclusions:The qualitative work here gives a clear indication that parents have a strong preference. This is data which would not be captured in traditional HTA reports, which tend to focus on quantitative data and meta-analysis. This is, however, information that is important to patients, and should inform clinicians and payers. We discuss how HTA do-ers should make efforts to find this data from ‘failed’ primary research and incorporate it into their reports, and how HTA do-ers could be alert to this situation.
OP141 A Patient-Reported Outcome Measure For Hemorrhoidal Disease
Authors: van Tol Robin , Kimman Merel , Melenhorst Jarno , Stassen Laurents , Breukink Stephanie , Dirksen Carmen 
Published: January 2019

Introduction:Treatment options for hemorrhoidal disease (HD) include conservative treatment (e.g. laxatives), rubber band ligation, and more invasive surgical treatment options. Outcomes reported in clinical trials evaluating treatment effectiveness are heterogeneous, making comparisons difficult. Moreover, clinical outcomes, such as recurrence, complications and symptoms, do not fully represent the relevant benefits and harms of treatment to the patient. We therefore developed (i) a core outcome set (COS) for HD treatment, and (ii) a patient-reported outcome measure (PROM) evaluating symptoms and impact on daily life.Methods:Literature review established outcomes most commonly used in studies evaluating HD treatment. A Delphi study with health professionals and patients was conducted to rank and discuss the outcomes in terms of importance and completeness, and reach consensus on a COS. In addition, individual patient interviews (n=15) were held to gain insight into patient experiences with HD and treatment. A panel of experts subsequently developed a PROM that focused on the core outcomes. Face and content validity were assessed (n=10) using a retrospective verbal probing technique.Results:Recurrent symptoms, complications and treatment satisfaction were the primary focus for health professionals, while patients were more concerned with overall impact on daily life. Patients ranked blood loss, pain and itching as the most bothersome symptoms. A PROM was developed, consisting of seven items covering three domains: severity of symptoms, impact on daily life, and treatment satisfaction (if applicable). The questions and response options were clear to patients and content validity was good. The questionnaire took approximately three minutes to complete.Conclusions:We developed a COS and a PROM for HD treatment. The PROM can be used in clinical trials as the primary outcome measure evaluating treatment effectiveness from the patient's perspective. It can also support shared decision-making regarding individual treatment pathways in clinical practice. A psychometric validation study is currently underway.
OP145 The Release Of The Fourth Edition Canadian Agency For Drugs And Technologies In Health (CADTH) Economic Guidelines – A Year In Review
Authors: Lee Karen , Coyle Doug 
Published: January 2019

Introduction:In March 2017, CADTH released the fourth edition of the Guidelines for the Economic Evaluations of Health Technologies. As part of the update a few notable changes were made to topics such as discount rate, target population, modeling, effectiveness, analysis, and the theoretical foundations for the Guidelines. In this presentation we will describe: the implementation of the Guidelines; approaches taken to facilitate the adoption of the Guideline statements; and the tools provided to assist users and doers in using cost-effectiveness information in healthcare decision making.Methods:Given some of the changes made to the Guidelines, CADTH identified the need to engage stakeholders early in preparation for the release of the fourth edition. Feedback on topics was sought from various stakeholders (researchers in the field, industry, patient groups, and decision makers) throughout the process. Also, suggestions for tools to support the understanding and implementation of the Guidelines were noted by CADTH. To further support use of the Guidelines, CADTH committed to undertake a number of activities including: workshops for decision makers and researchers; worked examples to illustrate the approaches; and development of tools to assist in the use of recommended methods. Updates to align drug submission guidance with the Guidelines are ongoing.Results:The final version of the Guidelines was greatly influenced by the stakeholder feedback received, with a focus on greater clarity. Whilst efforts to increase acceptance and adoption of the guidelines are ongoing, we present preliminary findings with respect to engagement with stakeholders and adoption of new guidance in drug submissions.Conclusions:The plan to engage stakeholders continues to be effective. As such, there has been general acceptance of the changes and an interest in education and tools to assist with implementation of the Guidelines.
OP150 Acquired Immune Deficiency Syndrome Benefit Package: A Financial Review
Authors: Wong John , Co Stephanie Anne , Espinosa Christine Ingrid , Zeck Wilibald , Bermejo Raoul , Silfverberg Denise 
Published: January 2019

Introduction:The Philippines has an increasing number of newly diagnosed cases of human immunodeficiency virus and acquired immune deficiency syndrome (HIV/AIDS). Most Filipinos rely on out-of-pocket (OOP) expenditure to finance their healthcare needs. In 2010, the Philippine National Health Insurance Corporation (PhilHealth) introduced an Outpatient HIV/AIDS Treatment (OHAT) package to cover the necessary basic healthcare expenses of patients. The objective of this study was to review the OHAT package in terms of patients’ financial risk protection, specifically the amount of OOP expenses incurred and the package's support value.Methods:The study was divided into two phases: (i) patient surveys (PS); and (ii) facility costing surveys (FCS). PS focused on information from enrolled and non-enrolled patients, specifically their current financial needs and expenses. The FCS reviewed actual cost breakdown for each treatment hub of package inclusions.Results:The calculated maximum support value of the package in 2015 was 267 percent. The median annual patient OOP expenditure was PHP 4,700 (USD 91). Maximum expenditure reached as high as PHP 392,000 (USD 7,551) per year mostly due to treatment for opportunistic infections (OIs), which are currently not included in the package. High OOP expenditure was also due to non-uniform coverage of services across different hubs; there was no consensus among providers on what specifically should be included in the package. This reflected a variety of package support values, with some hubs falling below patient expenditure.Conclusions:The current OHAT package, if properly implemented, is sufficient to cover the basic yearly healthcare needs of patients. However, non-uniform implementation and variation in prices of services per treatment hub means that coverage is not always sufficient in all areas, which can cause continued high OOP expenses for patients even with insurance coverage. Furthermore, coverage of OI's as the main driver of increased OOP expenses should be explored.
OP151 Weathering The Development To Adoption Storm: NICE Safe Harbors
Authors: McCracken Fay , Deakin Carla 
Published: January 2019

Introduction:Getting technologies adopted in the UK healthcare system can be time-consuming and complex. The National Institute for Health and Care Excellence Office for Market Access (NICE OMA) has developed a novel approach to enable greater and more coordinated dialogue between life sciences companies and healthcare system stakeholders on market access issues.Methods:When establishing NICE OMA, interactions were carried out with life sciences trade associations and key healthcare system stakeholders to explore challenges in market access landscape. Feedback highlighted that dialogue with NICE and other stakeholders is often limited and occurs in high-risk situations; indicating a need for greater and more coordinated dialogue between industry and multiple healthcare system stakeholders outside of formal processes.Results:The approach developed is a safe harbor engagement framework which enables NICE OMA to facilitate interaction between life sciences companies and key healthcare system stakeholders; this collaborative approach promotes shared understanding of aspects that will allow innovative technologies to reach patients faster. It brings together multiple organizations in a safe environment where ideas can be exchanged between participants, allowing organizations to think beyond their own area of interest and to work collaboratively. Companies have used the engagement framework flexibly to engage at different stages along the development to adoption journey. Feedback indicates that companies have benefitted from channeling discussions through NICE to bring together key leaders from different organizations, as well as the neutral facilitation of discussions. Healthcare system partners have gained insights/knowledge that hadn't been apparent beforehand. Patient and clinical representatives have appreciated the opportunity to provide views to a broad range of stakeholders often early in the development of the technology.Conclusions:The NICE OMA safe harbor engagement framework has been well-received to date. Further feedback will be sought to understand the impact in helping to optimize the market access journey.
OP154 Industry And Clinician Views Of Medtech Innovation Briefings
Authors: Burton Alexia Campbell , Unsworth Harriet 
Published: January 2019

Introduction:The National Institute for Health and Care Excellence Medtech Innovation Briefings (MIBs) are commissioned by the National Health Service (NHS) England and designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical, digital or diagnostic technologies. MIBs are fast flexible summaries of single technologies that are intended to be responsive to commissioners needs for information about innovative technologies. MIBs include a description of the technology, how it is used and its potential role in the treatment pathway. They also include a review of relevant published evidence and likely costs. As a relatively new product, the format of MIBs continues to evolve and in 2016 a more streamlined evaluation template was introduced. To ensure MIBs continue to meet users’ needs, a study was conducted to understand the opinions and requirements of core stakeholders and to identify key areas for future development.Methods:An initial cross-sectional online survey with NHS staff who were potential users of MIBs was carried out in December 2015. A second round of online and mail-out surveys were circulated between November 2016 and May 2017 to medical technology manufactures and an additional group of NHS staff. Descriptive analysis was used for all quantitative data and qualitative data was summarized using thematic analysis.Results:Thirty-nine medical professionals and fourty-two manufacturer representatives participated in the surveys. More than half of clinicians were aware of MIBs and thought that raising awareness and visibility should be a future priority. Manufactures regarded MIBs as having a positive or mixed impact on innovation, access, or uptake by the healthcare system.Conclusions:Stakeholders are using MIBs in a variety of ways and there was and a range of suggestions for their future development particularly regarding moving from single technology evaluation to simultaneous assessment of similar technologies.
OP158 Overview Of Technology Assessment For Multiple Sclerosis In The Brazilian Public Health System
Authors: Souza Kathiaja , Salomon Flavia , de Brito Artur Felipe 
Published: January 2019

Introduction:The National Committee for Health Technology Incorporation (CONITEC) has a structured process for the incorporation, disinvestment, or alteration of different health technologies in the Brazilian public health system and provides technical support for the decision-making process. Since its creation, CONITEC has received several submissions for the incorporation of medicines and the update of clinical practice guidelines for multiple sclerosis (MS). Nowadays, more than twelve different therapies are currently available to treat MS and the Brazilian clinical practice guideline, which was last updated in 2015, offers six medicines to treat MS that are divided into first, second, and third line treatments. The purpose of this study was to describe CONITEC's assessments of applications for incorporation, disinvestment, or alteration of medicines for MS.Methods:A case study method was used to evaluate information, retrieved from CONITEC's database, about the health technology reports developed by CONITEC's Executive Secretariat in response to applications received in the period from 2012 to 2017.Results:Ten technical reports on health technologies for MS were produced by CONITEC during the study period. This number represented four percent of the external submissions for incorporation of technologies for several clinical conditions in the public health system. Six medicines were evaluated. The highest number of submissions were for incorporation (n = 6), followed by alteration of treatment lines (n = 3), and disinvestment (n = 1); fifty percent of the submissions were not recommended. The main reasons for rejection were low or unproven efficacy, high budget impact, and inadequacy of the proposal based on the evidence presented. CONITEC's favorable recommendations caused a profound change in the current clinical practice guideline and had a significant impact on the health system.Conclusions:MS is considered a rare disease in Brazil, but there is significant pressure from society to provide better treatment options that will impact the MS scenario in the health system. The recent CONITEC assessments have led to a revolution in the treatment of MS in Brazil, which is now in the process of being updated.
OP161 Relationship Between Appropriateness And Arthroplasty Recommendation
Authors: Marshall Deborah , Faris Peter , Jones Allyson , Noseworthy Tom , Dick Don , Howden Jane Squire , Woodhouse Linda , Reczek Tania , Bohm Eric , Dunbar Michael , Hawker Gillian 
Published: January 2019

Introduction:We examined relationships between measures of total knee arthroplasty (TKA) “appropriateness” constructs and surgeon TKA recommendations in people with knee osteoarthritis (OA). Although TKA is highly effective, fifteen to thirty percent of recipients report dissatisfaction and/or little or no symptom improvement. More appropriate selection of surgical candidates may improve both patient outcomes and healthcare resource use, but no validated appropriateness criteria exist currently in Canada.Methods:Patients 30 years of age or older with knee OA referred for surgical consultation at two large joint arthroplasty centres in Alberta, Canada were invited to participate. Participants completed a standardized pre-consult questionnaire, which included the following sociodemographics and validated measures of appropriateness constructs for TKA: knee symptoms; non-surgical management; patient readiness for and expectations of TKA; and net patient benefit. Post-consultation, surgeons were asked to confirm knee OA and their recommendation. We used multivariable logistic regression to examine the relationship between measures of appropriateness constructs and receipt of surgeon TKA recommendation.Results:Of 3,009 patients approached, 2,360 completed the questionnaire and 2,064 (sixty-nine percent) were eligible at surgical consultation (mean age 65.7 years, standard deviation 9.1; fifty-nine percent were women); 1,495 (seventy-two percent) were recommended for TKA. The likelihood of receiving a TKA recommendation was independently associated with: knee symptoms (odds ratio [OR] per unit increase in pain intensity, 1.19 (95% confidence interval [CI]: 1.11–1.27)); prior non-surgical OA management (OR for prior knee injection, 1.53 (95% CI: 1.21–1.94)); readiness for surgery (OR if definitely/probably willing to undergo TKA, 3.03 (95% CI: 1.99–4.59)); and TKA expectations (OR outcome “very important”: ability to perform daily activities, 1.40 (95% CI: 1.04–1.88); straighten the knee/leg 1.42 (95% CI: 1.13–1.80); participate in exercise/sports 0.75 (95% CI: 0.58–0.98)).Conclusions:In our cohort of patients with confirmed knee OA who consulted a surgeon for TKA, appropriateness constructs were significantly associated with receipt of a TKA recommendation. Research is ongoing to evaluate the predictive validity of these measures for patient-reported outcomes associated with TKA.
OP163 European Network for Health Technology Assessment Joint Action 3 Relative Effectiveness Pilots: Pharma Company Experience
Authors: Hebborn Ansgar , Oberdiek André , Birkmose Jennifer Cain , Gyldmark Marlene , Ducournau Pierre , Bahar Nasim , Mowbray Kate 
Published: January 2019

Introduction:More than 50 HTA agencies evaluate the clinical value of medicines in Europe, resulting in duplication of work for HTA agencies and manufacturers, and lengthy and variable time to reimbursement for patients across Europe. A consistent, single European relative clinical scientific benefit assessment of medicines could become a key element in ensuring patients get equitable and timely access across Europe. The European Network for Health Technology Assessment (EUnetHTA) is responsible under Joint Action 3 (JA3, 2016–2020) to pilot more than 30 Relative Effectiveness Assessments (REAs) of medicines. The first EUnetHTA JA3 REA pilots are now being completed and Roche, with its participation in the REA pilot for alectinib, has gathered relevant experience.Methods:The goal of this analysis is to summarize and reflect upon the experience with one of the first EUnetHTA REA assessments in JA3. The authors also propose potential process improvements.Results:The experience with the alectenib REA shows that EUnetHTA processes have improved compared to JA2. The timing of the assessment has been aligned with the EU regulatory marketing authorization process by shortening the duration of the scoping phase. More EUnetHTA members than in JA2 seem to be committed to use the reports in national HTA, pricing and reimbursement processes. At the same time, the REA pilots have identified other areas that could benefit from further refinement, for example the active engagement of patient group representatives and clinical experts, rules and principles related to the handling of confidential information.Conclusions:Based on the limited number of REA pilots for medicines it is too early to draw final conclusions on the state of EU-level collaboration. But first signals indicate a positive development compared to REA pilots conducted in JA2. Interim evaluations are recommended to assess progress, and capture learnings for future pilots.