bluuebunny/crossref_metadata_2025_split huggingface dataset:
PP41 Toward Rules For Stakeholders’ Involvement In Regional Health Technology Assessment Units
Authors: Roy Mathieu , Déry Véronique , Dagenais Pierre 
Published: January 2019

Introduction:Health services users must participate in health technology assessment (HTA) activities. Users, caregivers, and citizens have the practical experience of healthcare and social services. HTA outputs are more useful when values and preferences of patients, caregivers, and citizens are taken into account. Despite this, the best methods of stakeholders’ involvement, timing for doing so, selection of participants, and the type of users to recruit depending of methods and contexts remain unspecified. Herein, an involvement policy has been developed to formalize the participation of users, caregivers and citizens in the services offering of a regional HTA unit.Methods:A steering committee composed of stakeholders (i.e. user, caregiver, citizen, User Experience Service representative, manager, provincial HTA body representative, HTA unit members) was constituted to discuss user involvement in a regional HTA unit. A preliminary vision statement emerged from this committee, and included objectives and principles for users, caregivers, and citizens participation. This statement was deliberated using a Delphi consensus method. Three rounds of deliberations were needed to reach a strong consensus.Results:Four objectives and four principles that should underlie the development of an involvement policy reached consensus. Participants agreed that users, caregivers, and citizens should: i) propose principles of involvement for each HTA projects; ii) co-realize evaluations with HTA professionals; iii) contribute to evaluation processes; and, iv) be involved in some management decisions of regional HTA units. Four principles to formalize users, caregivers and citizens’ involvement in regional HTA units also emerged. These principles were about utility and feasibility of involvement as well as ethical and methodological considerations.Conclusions:Users, caregivers, and citizens must participate in the activities of regional HTA units. Each of them have different roles and can contribute to evaluation processes. Their involvement in HTA activities is warranted for co-producing better evaluation more adapted to users’ needs in healthcare and social services.
PP44 Effectiveness Of Insulin Glargine Versus Detemir In Type 1 Diabetes
Authors: Silva Thales , Fernandes Almeida Paulo Henrique Ribeiro , Araújo Vânia , Guerra Augusto , Acurcio Francisco , Alvares Juliana , Godman Brian , de Lemos Livia Pires 
Published: January 2019

Introduction:The use of long-acting insulin analogues have been reported in patients with type 1 diabetes mellitus who exhibit important oscillations of their daily blood glucose, although the therapeutic benefits are lacking. The aim of this study was to evaluate the effectiveness and safety of the insulin analogue glargine compared detemir to support health decision-making.Methods:We performed a systematic review with meta-analysis of observational studies (cohort and registry), available in the MEDLINE (Pubmed), Latin American and Caribbean Health Sciences (LILACS), EMBASE and Cochrane Library databases (accessed August 2017), including research in the electronic journal Diabetes Care and gray literature. Several combinations of terms were used, including disease terms, interventions and type of study. The results evaluated were: glycated hemoglobin; weight gain; occurrence of severe hypoglycemia; total insulin dose; and, fasting capillary glycemia. Methodological quality was assessed using the Newcastle scale. The meta-analyses were performed in Review Manager® 5.2 software using a random effects model. Protocol number CRD42017054925 (International Prospective Register of Ongoing Systematic Reviews).Results:A total of 705 publications, eight cohort studies were included. The quality of included studies was classified as high. In the meta-analysis, the results for episodes of severe hypoglycemia (p = 0.002), measurements of fasting capillary glycemia (p = 0.01), and weight gain (p = 0.001) were favorable for detemir. The glycated hemoglobin endpoint (p = 0.49, heterogeneity = 89 percent) revealed high heterogeneity and no statistically significant difference between groups, showing no difference between the interventions for glycemic control.Conclusions:Although some results are favorable to detemir, it was not possible to identify significant differences in effectiveness and safety between the two analogues evaluated, requiring new long term studies and better quality of methodological studies.
PP53 New Medical Device Law: Germany's Experience With Refund Restrictions
Authors: Müller Elvira , Neeser Kurt , Oelze Ilse-Barbara 
Published: January 2019

Introduction:Since 2005, new hospital examination and treatment methods (NUB) were reimbursed by hospital individual supplementary fees as long as they were not sufficiently covered by a DRG. In 2016, the NUB procedure was decisively changed by legal norm §137 h SGB.V to evaluate medical devices (MD) of high risk classes, particularly invasive, or new theoretical-scientific concepts versus treatment alternatives by the Federal Joint Committee (G-BA). Hospitals and manufacturers have to submit detailed information on the application of the MD and the scientific evidence to G-BA along with a NUB application. This assessment may lead to exclusion of the method from reimbursement by the statutory health insurance (SHI).Methods:The published MD consultation submissions, assessments and G-BA resolutions (to date) were analyzed regarding evaluation criteria, treatment potential and study obligation.Results:In 2017, nineteen procedures were reviewed by G-BA with respect to §137 h. Two ultra-controlled high-intensity focused ultrasound (HIFU) indications were regarded as having potential benefit but not sufficient evidence yet, thus respective studies have to be initiated. Three procedures were regarded as eligible according to §137 h but not yet evaluated. Six procedures (ultra-controlled HIFU in five indications, targeted lung denervation in chronic obstructive pulmonary disease) were rated as having no potential benefit, while eight procedures were regarded as not eligible according to §137 h.Conclusions:Initially put into place for high risk class and primarily invasive devices, consultations and assessments under §137 h show that there is some uncertainty around applicability criteria. The majority of those procedures which fell under the assessment law failed to be granted potential benefit as treatment alternative. Currently consultations are ongoing which could possibly lead to the exclusion of these methods from the performance spectrum of the SHI. Manufacturers should revise their study concepts in order to fulfill the specific demand for robust evidence.
PP67 Validity Of A Questionnaire Assessing Patient Medication Experiences
Authors: Kimman Merel , Wijsenbeek Marlies , Mostard Remy , Tak Nelleke , Rotteveel Adrienne , van Jaarsveld Xana , Storm Marjolein , Wijnsma Kioa , Gelens Marielle , van de Kar Nicole , Wetzels Jack , Dirksen Carmen 
Published: January 2019

Introduction:The Patient Experiences and Satisfaction with Medications (PESaM) questionnaire was recently developed. It consists of two disease-specific modules for evaluating drug treatment of idiopathic pulmonary fibrosis (IPF) and atypical hemolytic uremic syndrome (aHUS): (i) a generic module applicable to any medication, and (ii) a patient expectations module. This study assessed the validity and reliability of the generic module in a large sample of patients in the Netherlands.Methods:In 2017, the PESaM-questionnaire was sent out to IPF patients on pirfenidone or nintedanib, aHUS patients receiving eculizumab, and patients using advagraf after kidney transplantation. The generic module consists of 16 items related to the domains effectiveness, side-effects and ease of use, and assesses patient experiences regarding the impact of the medication on daily life and health, and satisfaction. Mean scores for each domain were calculated using a scoring algorithm. Content validity, construct validity, and reliability were assessed using recommended methods.Results:Patients (n=188) completed the generic module of whom 48 percent used pirfenidone, 36 percent nintedanib, 11 percent advagraf, and 5 percent eculizumab. Content validity was established. Expected associations between patient experiences, satisfaction, and quality of life (QoL) were generally confirmed, demonstrating construct validity. For example, a moderate to strong positive association was found between patient experiences and satisfaction with side-effects (correlation coefficient 0.625, p < 0.05), and low (positive) associations were found between patient experiences and QoL. Importantly, the PESaM-questionnaire was able to discriminate between patients using different medications. Intraclass correlation coefficients, for test-retest reliability, ranged between good and excellent for most domains.Conclusions:The PESaM questionnaire is a promising tool to provide scientific evidence regarding the patient's perspective in health technology assessments and reimbursement decision-making regarding (expensive) medications, but can also support shared decision-making and appropriate use of medication at the individual patient level. Further research will assess the questionnaire's responsiveness and generalizability of results to other patient populations.
PP96 Which Data For Dual Mobility Cups In Hip Arthroplasty?
Authors: Guerin Caroline , Olivier Cyril , Marguerite Camille , Pacull Aurélie , Collignon Corinne , Galmiche Hubert , Belorgey Chantal 
Published: January 2019

Introduction:The dual mobility concept was invented to prevent postoperative hip dislocation. It has been used for 40 years, but demonstrative data are limited and many designs are available. In France, many implants for hip arthroplasty are reimbursed by the national health insurance system through a generic description that corresponds to a class of products having the same indications and technical features (designs, coatings, types and systems of fixation). Dual mobility cups were one of them until 2017. The ministry decided to set up the assessment of each design of dual mobility cup, marketed in France for their reimbursement.Methods:Manufacturers of these devices submitted medico-technical application dossiers, with technical characteristics and clinical data, to the French National Authority for Health (HAS). HAS has assessed prospectively the actual benefit of these implants.Results:Sixteen companies marketing 42 kinds of dual mobility cups associated with 22, 28 or 32 mm femoral heads and cementless or cemented fixations have submitted dossiers. Their demands were argued on non-specific and specific clinical data. For few implants with non-specific clinical data, arguments to demonstrate the equivalence towards other implants were not accepted for reimbursement. For other implants, the specific data available were only low quality studies. No randomized controlled trials were identified. When the risk/benefit balance was acceptable, the implants were approved for reimbursement and HAS required post-launch data to assess the real-world safety of these implants (i.e. dislocation and long-term survival).Conclusions:All the dual mobility cups marketed in France have been assessed by the French health technology assessment authority. Most of them have been approved for reimbursement, despite of low level of evidence. The brand name inscription enables a specific follow up and the analysis of a post-approval study results in five years.
PP103 Early Decision Support In Innovative Procurement
Authors: Stome Linn Nathalie , Hengebol Kari , Kidholm Kristian , Kvaerner Kari 
Published: January 2019

Introduction:Procurement is one tool for the public sector to acquire need-based, innovative and effective solutions. To succeed in purchasing services that succeed in improving patients’ outcomes and optimize cost of care, the process must be accompanied with tools for early decisional support. Documenting the effects of healthcare innovation is therefore fundamental when dealing with prioritizing adequate technology. The aim of the present study was to review the literature to identify early assessment methodology applicable to innovative procurement processes.Methods:A scoping review was performed in January and February 2017 with the objective of selecting literature reporting on early assessment of health innovation. Methods for early assessment of health innovation were identified with the aim of investigating whether the methods change depending on where in the innovation process (development, introduction, and early diffusion) they are applied, and if the literature pointed to dominant methods. Next, critical elements of the innovative procurement process were identified, and methods relevant to the need-based phase of procurement were assessed.Results:In total 1064 articles met the search strategy. Based on predefined inclusion and exclusion criteria, thirty-nine articles were included in the study. When viewed in the light of innovative procurement, stakeholder insight was an important source of data in early assessment of potential benefits of health innovation. Such data can be applied in scenario analyses to provide necessary outcome overviews and to direct and accelerate the procurement process. Further, various simulation and analysis methods may be used in new ways to increase the impact of the scarce availability of data in early innovation phase.Conclusions:The present review identified tools for early decisional support that address risks and step-wise healthcare management support. Information based on the present review will also be addressed in Panel 26 “Accelerating Value Based Health Care with Innovative Procurement and Early Decisional Support”
PP109 Use Of Speech Recognition In Medical Reports: A Systematic Review
Authors: Poder Thomas , Déry Véronique , Fisette Jean-Francois 
Published: January 2019

Introduction:Speech recognition is increasingly used in medical reporting. The aim of this article is to identify in the literature the advantages and weaknesses of this technology, as well as barriers and facilitators to its implementation.Methods:A systematic review of systematic reviews has been conducted in PubMed, Scopus, Cochrane Library and Center for Reviews and Dissemination up to August 2017. The grey literature has also been consulted. The quality of systematic reviews has been assessed with the AMSTAR checklist. Inclusion criteria were to use speech recognition for medical reporting (front or back-end). A Survey has also been conducted in Quebec, Canada, to identify the dissemination of this technology in this province, as well as the factors of success or failure in its implementation.Results:Five systematic reviews were identified. These reviews indicated a high level of heterogeneity across studies. The quality of the studies reported was generally poor. Speech recognition is not as accurate as human transcription but can dramatically reduce the turnaround times for reporting. In front-end use, medical doctors need to spend more time for dictation and correction than with human transcription. With speech recognition, major errors can be up to three times more frequent. In back-end use, a potential increase in the productivity of transcriptionist is noted.Conclusions:Speech recognition offers some advantages for medical reporting, the main one being a reduction in turnaround times. However, these advantages are challenged by an increased burden for medical doctor and risks of additional errors in medical reports. It is also hard to identify for which medical specialties and which clinical activities the use of speech recognition will be the most beneficial.
PP116 Health Utilities And Neglected Conditions: A Chagas Disease Study
Authors: Miguel Sandro , Bagattini Ângela , Cruz Luciane , de Almeida Eros 
Published: January 2019

Introduction:Chagas disease (ChD), also known as American trypanosomiasis, is a neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi. About 6 to 7 million people worldwide are estimated to be infected, most in Latin America. Health-related quality of life (HRQoL) and utility measures are still poorly employed for assessment of ChD lifetime impairments. Brazilian HRQoL published data showed that the cardiac subgroup of patients have worse scores than other ChD chronic groups. For the time being, utility scores are not available yet for the ChD population. The present study aims to assess quality of life (QoL), as utility scores, of patients with chronic Chagas Disease.Methods:This is a cross-sectional study. Data were collected from 183 outpatients with chronic ChD in a reference center in Brazil. Information pertaining to sociodemographics, clinical status, and quality of life were collected using self-administered questionnaires. Utilities were obtained by the European Quality of Life – 5 Dimensions (EQ-5D) questionnaire. Comparisons were made between clinical subtypes and population normative values. Continuous variables were compared using t-test or ANOVA, and categorical variables were compared using Chi-square test. Associations between QoL and patient characteristics stratified by demographics, clinical status were identified by linear regression models.Results:Most subjects were female (61 percent). The average age of men was 53.3 years and women 56.6. When analyzing the EQ-5D utility scores, it was observed that the results were lower for cardiac patients (0.610–95% CI 0.582–0.638) in comparison to indeterminate form patients (0.659–0.632–0.687). When comparing patients with the general population of the same age and sex, patients with ChD showed lower utility scores than normative values (0.624–95% CI 0.596–0.652).Conclusions:Chronic ChD causes a negative impact on quality of life, physical functioning, as well as psychosocial function, with the impairment becoming worse in cardiac patients.
PP122 A Quick Cost-Effectiveness Analysis Of Patent Foramen Ovale Closure In Korean Patients With Cryptogenic Stroke
Authors: Ahn Jeonghoon , Kim Eung Ju , Oh Kyungmi , Yoo Justin Seung-Ho , Koullick Maria 
Published: January 2019

Introduction:Patent foramen ovale (PFO) is an open hole between the right and left upper chambers of the heart. It may increase the risk of stroke, so closure of the hole is considered a secondary prevention in patients who have experienced cryptogenic stroke. Recent evidence has been published on the effectiveness of PFO closure, including a publicly funded prospective study on the effectiveness of PFO closure for preventing recurrent stroke or transient ischemic attack in selected Korean patients who have experienced cryptogenic stroke. The objective of this study was to examine the cost-effectiveness of PFO closure using this recent evidence.Methods:Available clinical data from the aforementioned Korean prospective study and other recent multicenter trials funded by public bodies were used. The cost data were obtained from the current Korean National Health Insurance fee schedule. Utility data were extracted from local research on stroke patients. A cost-effectiveness analysis, based on a 20-year Markov model, was conducted using these data to compare PFO closure plus antiplatelet therapy with oral anticoagulants alone.Results:The initial analysis showed that PFO plus antiplatelet therapy costs KRW 7.13 million (USD 6,547) more than oral anticoagulants alone but has a higher utility of 1.3 quality-adjusted life-years (QALYs) per patient, which corresponds to an incremental cost-effectiveness ratio (ICER) of KRW 5.6 million (USD 5,142) per QALY. The implicit Korean ICER threshold is KRW 25 million (USD 22,955) for non-cancer drugs, so it seems that PFO plus antiplatelet therapy is cost effective in the Korean setting.Conclusions:Since this study used some transition probabilities from foreign sources, the results may not be completely transferable to the Korean setting. However, this is the best available evidence so far in Korea for the economic evaluation of the PFO closure procedure. Therefore, use of PFO closure in carefully selected patients with a history of cryptogenic stroke may benefit the public payer in Korea.
PP124 Health Technology Assessment And Feedback For Healthy Workplace Culture In Malaria Care In Low And Middle Income Countries
Authors: Okwen Patrick , Cheabum Raphael , Che Etienne , Mbunu Joy Ngwemsi , Nkangu Miriam 
Published: January 2019

Introduction:Malaria is a leading cause of mortality and morbidity in children under five in low and middle income countries (LMICs). Management of malaria in children under five years of age is challenging. One challenge faced by clinical practice in LMICs is lack of evidence to guide practice. This challenge is further compounded by different training backgrounds of team members. In the management of malaria in Cameroon, conflicts usually arise between clinicians, lab technicians and pharmacists resulting in over diagnosis and treatment of malaria. The patient's view is usually not considered. This leads to over diagnosis and over prescriptions for malaria in children under five years of age.Methods:We used the Joanna Briggs Institute (JBI) approach of getting research into practice to organize stakeholder meetings, assess existing evidence in malaria care, develop evidence criteria for management based on levels of evidence, assess the gamut of care for malaria, provide feedback to clinicians and re-assess practice. We used the JBI practical application of clinical evidence system (PACES) and getting research into practice (GRiP) evidence implementation tools in the process to facilitate teamwork, collaboration on evidence and provide feedback.Results:A collaborative approach to assessments and feedback including all healthcare stakeholders significantly improved workplace culture of evidence-based care and staff-to-staff relationships as well as staff-to-patient relationships. Over a period of twelve months, we reported eighty-four percent fewer conflicts between staff and ninety-eight percent fewer conflicts between staff and patients. For malaria management, overall criteria showed a thirty-one percent improvement in compliance with best practice recommendations with evidence levels of Grade 1.Conclusions:The project demonstrated that local leadership and evidence-based care can significantly improve practice in resource limited settings.