Conference Theme: Towards an HTA Ecosystem: From Local Needs to Global Opportunities
Poster Presentations
PP148 Development And Evaluation Of A Tool Supporting Prescription Behavior
- Valentina Lorenzoni, Vincenzo Ferrari, Cinzia Freschi, Giuseppe Turchetti
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- Published online by Cambridge University Press:
- 12 January 2018, p. 139
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INTRODUCTION:
The increasing complexity of decision-making in clinical practice and the financial pressure requires clinicians to develop some background about the economic consequences of their decisions and to become more and more managers of pre-defined budgets. The present work aims at describing a simple technology solution that could support prescription decisions and illustrates the results of a preliminary assessment of the tool in a sample of professionals. The solution has been developed to allow informed decision-making in the prescription of oral anti-diabetic drugs (OADs) in type II diabetes mellitus (T2DM) patients by supporting prescriptive appropriateness.
METHODS:The tool developed is compatible with many kinds of hardware architectures and the most diffused web browsers. The system allows real-time reproduction of economic evaluation of the different therapeutic options for the management of T2DM patients. Assessment of “ease to use” and “usefulness” of the tool was performed in a convenience sample of clinicians and pharmacists through a specific questionnaire.
RESULTS:The tool was developed to compare dipeptidyl-peptidase inhibitors (DPP4i) with sulfonylureas, as second line therapy, for T2DM patients. The tool has a user-friendly Graphical User Interface allowing users to quickly and easily select the therapeutic options to compare, choosing geographical context, perspective of analysis, and changing some model parameters. Feedbacks obtained from thirty-three different professionals were generally positive for the “ease to understand information offered”, “ease of introduction of the tool to support usual working activity”, “usefulness within the usual working activity”.
CONCLUSIONS:The study showed that the introduction of the tool as a support for clinicians in optimizing their practice could satisfy unmet needs of professionals by supporting informed prescriptive appropriateness in the choice of OADs as it allows to consider diabetes drug related costs in a comprehensive way. The routinely use of the tool developed could become a solution helping clinicians in the management of several diseases.
PP149 Assessment Of New Medical Devices With Administrative Databases
- Giuditta Callea, Maria Caterina Cavallo, Rosanna Tarricone
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 139-140
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INTRODUCTION:
Administrative data (for example, hospital discharge databases, HDDs) can be used as a real world source of clinical and economic evidence for assessing new medical devices (MDs), provided that their use can be identified in the data. In absence of updated classification systems for procedures and diagnoses, which allow to identify the use of new technologies in the data, traceability can still be achieved thanks to authorities coding guidelines (that is, indication on how to combine the existing codes for procedures and/or diagnoses when new technologies are used).
In 2009 Italy adopted version 2007 of the International Classification System of Diseases (ICD-9-CM) and version 24 of Diagnosis Related Groups (DRGs), which are still in use. The aim of this work was to investigate the capacity of the classification system currently used in Italy, which is at high risk of obsolescence, to identify innovative MDs.
METHODS:To achieve our goal, we performed a systematic search of all the national and regional coding guidelines published from 2009 (that is, the year of introduction of the new classification systems) to 2015. We extracted from each document the list of technologies for which the Ministry of Health and/or the Regional Authorities provided with coding indications.
RESULTS:Our results show that only a few recent technological innovations can be identified in the Italian HDDs. This reduces the possibility for decision makers to measure new technologies outcomes and costs in the real world clinical practice.
CONCLUSIONS:The traceability of new MDs' can support Heath Technology Assessment (HTA). Indeed, HTA programs should use real world evidence to re-assess MDs 2–3 years after their introduction in clinical practice. The use of routinely collected data, such as HDD, would allow to measure new technologies' “real” effectiveness in “real” world, on “real” patients in “real” hospitals to complement the evidence from Randomized Controlled Trials.
PP150 Rapid Analgesia For Prehospital Hip Disruption: A Feasibility Study
- Jenna Bulger, Alan Brown, Bridie Evans, Greg Fegan, Simon Ford, Katy Guy, Sian Jones, Leigh Keen, Ashrafunnesa Khanom, Ian Pallister, Nigel Rees, Ian Russell, Anne Seagrove, Helen Snooks
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 140-141
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INTRODUCTION:
Adequate pain relief at the scene of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilize and long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated (1).
METHODS:We undertook a randomized controlled feasibility trial using novel audited scratchcard randomization to allocate eligible patients to FICB or usual care. Paramedics are recruited and trained to assess patients for hip fracture and carry out FICB. We will follow up patients to assess accuracy of paramedic diagnosis, acceptability to patients and paramedics, compliance of paramedics and also measures of pain, side effects, time in hospital and quality of life in order to plan a full trial if appropriate. The primary outcome measure is health related quality of life, measured using Short Form (SF)-12 at 1 and 6 months. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. This study was funded by Health and Care Research Wales (1003).
RESULTS:We have developed:
• paramedic pathway to assess patients for hip fracture and FICB
• paramedic training package, delivered by Consultant Anaesthetist
• randomization scratchcards.
To date we have recruited nineteen paramedics; ten are fully trained and recruiting patients, the remainder are being trained. Fifty-four patients have been randomized and thirty-five have consented to follow-up. Thirteen 1-month and five 6-month follow-up questionnaires have been received.
CONCLUSIONS:This study will enable us to recommend whether to undertake a definitive multi-centre randomized controlled trial of FICB by paramedics for hip fracture to determine if the procedure is effective for patients and worthwhile for the National Health Service.
PP155 The Impact Of Lawsuits In The Brazilian Public Health System
- Carla Biella, Viviane Pereira, Fabiana Raynal, Jorge Barreto, Vania Canuto, Clarice Petramale
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- 12 January 2018, p. 141
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INTRODUCTION:
The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.
METHODS:A narrative review by literature search using key terms of legalization in specific databases was conducted.
RESULTS:Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.
CONCLUSIONS:For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.
PP156 New Information And Communication Technologies And Hospitals' Design
- Eduardo Alves, Benefran Bezerra
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- Published online by Cambridge University Press:
- 12 January 2018, p. 142
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INTRODUCTION:
The hospital's design today must be prepared for changes resulting from the incorporation of new information and communication technologies (ICT) (1). These will affect non-finalistic (warehouse, archive), diagnostic support (laboratory and image) and finalistic activities (emergency, surgical center, clinics) (2). The Health Technology Assessment (HTA) is fundamental in the dimension of the impact of each technology on the structure of healthcare facilities (HCF). In this way, this work intends to evaluate the trends of impact of the new ICT on hospitals’ structure.
METHODS:The main technologies under discussion in Management of HCF in Brazillian Health Regulatory Agency were raised. From this survey an impact matrix was built with hospital environmental design and the trends of adequacy of its space.
RESULTS:ICT that tend to decrease the physical space are: electronic health record for the archive, use of digital imaging for radiology, Radio-Frequency Identification (RFID) for the warehouse, point of care and automated laboratory equipment for clinical laboratories.
ICT that tend to increase physical space are: Telemedicine for the surgical center, Internet of Things - IoT for Intensive Care Units, beds for emergency and hospitalization.
The technologies that present an undefined tendency in relation to physical space are: automatic dispensers of drugs for nursing posts.
The use of database servers and the need for network points are still undefined due to the use of Wi-Fi technology and cloud storage. However, it's possible to increase use of electricity and the internet.
CONCLUSIONS:It is concluded that the new ICT will have an impact on the planning and building of the future HCF (3). The designs of today's buildings should consider this trend so that the future reality is adequate and the regulatory requirements about HCF should be able to consider it.
PP166 From An Institutional Strategic Plan To A Knowledge Transfer Tool For Health Technology Assessment: Case Of Drug-eluting Stents
- Thomas Poder, Jihane Erraji, Lucien Coulibaly, Kouamé Koffi, Jean-Francois Fisette, Pierre Dagenais, Véronique Déry
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 142-143
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INTRODUCTION:
Knowledge transfer (KT) of Health Technolgy Assessment (HTA) results presents numerous challenges, one being the lack of time of busy decision makers. Our hospital-based HTA unit is now part of a large network comprising 100 installations. To bridge the gap between complex HTAs and even more limited time by executive officers and managers, we needed to develop a new approach to deliver effectively key HTA messages. We initiated a new strategy with a report on drug-eluting stent (DES). DES may have the potential to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention (PCI). However, the technology is expensive and some concerns about safety remain. The second generation of DES stents show promising results in terms of efficacy and safety.
METHODS:We conducted a systematic review of meta-analyses comparing bare-metal stents (BMS) with second generation DES. Data extracted were used to perform a cost-benefit analysis for our organization. Main findings were illustrated in relation to the strategic plan of our institution.
RESULTS:As compared to BMS, the second generation of DES is very effective and potentially leads to huge savings. Safety is improved as regard to myocardial infarction, but not to mortality. For our institution, the use of second-generation DES has the potential to reduce waiting lists for a PCI. In an effort to improve clarity of the results and increase knowledge transfer among managers, we developed a new communication strategy involving the six axes considered as strategic by our Chief Executive Officer, namely: university mission, judicious use of resources, accessibility and quality of care and services, to build for and with the staff, and to act for and with the patient and his family. This led to a smart visual scheme directly showing the results in terms of what is important for our hospital. This initiative was very appreciated by managers.
CONCLUSIONS:Using our institutional strategic plan to communicate our results allowed a greater visibility of HTA activities and was greatly appreciated by managers. This will help in disseminating our results locally and in promoting the utility of HTA.
PP168 Combination Therapy Versus Intensification Of Statin Monotherapy
- Mouna Jameleddine, Hela Grati, Asma Ben Brahem, Khalil Jlassi, Hella Ouertatani, Wafa Allouche, Khaled Zghal, Randa Attieh, José Asua, Iñaki Gutiérrez-Ibarluzea, Marie Christine Jebali
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 143-144
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INTRODUCTION:
Coronary heart disease (CHD) is the most common cause of mortality globally. The burden of CHD is a challenge for Tunisia causing 27.14 percent of total mortality (1).
Statins are the leading molecules used to prevent CHD in Tunisia. The amount paid by the national insurance fund for statins in 2015 represents 9 percent of total drug expenditures (2).
INASanté has launched a Health Technology Assessment (HTA) study to compare the intensification of statin monotherapy versus a combination therapy for the CHD prevention in patients with moderate to high cardiovascular risk. The aim of this contextualized HTA report is to diminish prescription variability and not justified therapies.
METHODS:Research was carried out in the following databases: CRD, NICE search evidence, Cochrane, Belgian Health Care Knowledge Centre (KCE), Canadian Agency for Drugs and Technologies in Health (CADTH), Adelaide Health Technology Assessment (AHTA), Institut National d'excellence En Santé et en Services Sociaux (INESS), Euroscan International Network, National Institute for Health Research (NIHR), Agency for Healthcare Research and Quality (AHRQ) and Haute Autorité de Santé (HAS) from 2006 to 2017. Title, abstract and full text screening were performed by two independent reviewers relying on prespecified eligibility criteria. Critical appraisal of literature was conducted using INAHTA and PRISMA checklists, FLC 2.0 and The European Network for HTA (EUnetHTA) adaptation toolkit. One review from AHRQ was retained.
An adaptation process has been launched. Data on lipid lowering agents intake from key institutions have been gathered and a qualitative study has been started through interviews with thirty-three cardiologists and general practitioners from public, private sector and scientifc societies. Interviews have been analysed using NVivo. After results discussion with the working group, the report will be synthesized and validated.
RESULTS:According to the AHRQ report, all evidence for clinical outcomes were graded insufficient when comparing the therapies. Results on lowering low density lipoprotein (LDL-C) depend on the combination agent Ezetimibe has shown remarkable results (3).
The Tunisian context shows that there is no standardized method to assess the cardiovascular risk according to the preliminary results. The only combination therapy reported is with fibrates, mainly in case of associated hypertriglyceridemia. Ezetimibe has not yet obtained the marketing authorization.
CONCLUSIONS:There are significant differences between contexts and among practitioners prescriptions. This can be related to the lack of common guidelines and inequitable access to drugs and healthcare resources in general.
PP170 Health Impact Assessment Of Teleradiology Programs In Disadvantaged Areas
- Ottavio Davini, Giovanni Digiacomo, Matteo Perusia, Valeria Romano, Chiara Rivoiro, Rosario Servetto, Marika Giacometti, Marco Glisoni, Maria Rosaria Gualano, Roberta Siliquini, Marco Grosso
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 144-145
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INTRODUCTION:
Within the Home Radiology service of the Piedmont Region - R@dhome (1) - it was decided to employ a mobile radiological service to allow minor radiological procedures to be conducted in rural areas. Cortemilia (average age of population 51.6 years, population over 65 years 33.6 percent) is situated in Piedmont (Langhe region) and it is about 40 kilometers, with bad roads, from the nearest hospital. For this reason it's important to optimize the potential offered by telemedicine. The purpose of R@dhome is to provide simple radiological services (ambulatory) to vulnerable patients in outpatient settings. The aim of this work was to implement an assessment, based on Health Impact Analysis (HIA) (2,3) criteria, of the health intervention provided by the R@dhome service.
METHODS:From January 2016 to December 2016 the following were assessed:
• number of patients examined in the local radiological ambulatory service
• inhabitants opinions (using questionnaires)
• General Practitioner, Pharmacist, Family nurse opinions (using semi-structured interviews)
• stakeholder opinions (Mayor, local politicians, using semi-structured interviews)
• number of cars and ambulances used for the transport of patients to the nearest hospital
• number of patients who avoided transportation to the nearest hospital
• pollutants PM10 (particle size 10) related to cars and ambulance traffic.
RESULTS:Forty percent of people interviewed were more than 60 years old, 76 percent needed x-rays (in 2015), 96.8 percent considered it useful to have a closer x-ray service, only 42 percent had a driver's licence but preferred not to drive; GP's said that 50 percent of local patients had trouble reaching the hospital and that 30 percent of local patients need informal or formal care. From Januay to December 2016 we examined (mainly chest and bone x-rays) in 598 patients using as an alternative to private cars and ambulances the radiological mobile station, and the pollutant emissions were shown to be reduced by 85 percent.
CONCLUSIONS:This study has provided a comprehensive HIA report which shows that the R@dhome intervention improves patient's QOL, reduces social costs, reduces the number of patients in the Hospital Radiology Department, reduces rate of hospitalization and pollution.
PP171 Immuno-Oncology: A Patient Perspective
- Judith Rubinstein, S. Yin Ho, Emily Rubinstein, Rachel Sliman
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 145-146
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INTRODUCTION:
New immunotherapies have had great successes, but also incredibly debilitating side effects for patients. This discrepancy needs to be a focus of pharmaceutical companies because it will affect the way Health Technology Assessment (HTA) agencies review drugs. Two or three case studies of patient and caregiver experiences surrounding immuno-oncology clinical trials, both past and ongoing, will be used in order to gain a better understanding of how these trials have impacted individuals.
METHODS:Conduct in-person or telephone interviews with patients and their caregivers to find out more about patient experiences and see how key takeaways can help pharmaceutical companies better prepare submissions for HTA agencies as they launch future immuno-oncology drugs.
RESULTS:Preliminary results indicated that a patient completed a course of treatment and is very happy with the results. She had metastatic melanoma on her scalp. When she was being prepared for surgery, two new tumors on her scalp were discovered. As a result, she was included in a melanoma clinical trial.
Another patient is still undergoing treatment and is responding, but is experiencing severe side effects that are impacting his life and that of his primary caregiver. He was hospitalized once for sepsis.
CONCLUSIONS:Patient experiences can wildly vary. It is an area that needs more careful study, using both formal metrics and individual stories. Giving more attention to quality of life creates an opportunity for stronger submissions to HTA agencies and better assessments by those agencies.
PP172 Recruiting Academic Physicians Without Financial Conflict Of Interest
- Jacques Belghiti, Stéphanie Luzio, David Fuks, Gregory Emery
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- Published online by Cambridge University Press:
- 12 January 2018, p. 146
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INTRODUCTION:
To minimize the potential impact of conflicts of interest on health recommendations, several health institutions may be reluctant to recruit academic physicians due to their potential close relationship with industry. The present study aimed at evaluating the influence of academic physicians (AP) on the “rate of deport” due to financial support in the national commission of the HAS assessing medical devices.
METHODS:After the renewal of this commission in November 2015, introducing patients representatives and more academic physicians, two periods of 12 months immediately before and after that date have been compared regarding the rate of deport during the sessions. Deport were decided by the legal section of our institution one week before each meeting according to a complete analysis of potential financial conflict of interest related to the medical device assessed. Only members without significant financial conflicts were allowed to participate to the discussion and the vote. The assessment of potential conflict of interest of all members followed the same criteria during the two periods.
RESULTS:The number of physicians increased in the second period (nineteen versus twenty-three) with a significant higher rate of academic physicians (63 percent versus 82 percent, p = .001). The mean attendance of physicians was significantly lower during the second period (80 percent versus 65 percent, p = .03). During the two periods, the number of meetings (n = 22) was similar and the number of dossiers assessing new products was comparable (96 versus 104, p = .872). The decision to reimburse the medical devices was similar in the two periods (78 percent versus 73 percent, p = .681). The number of cases when physicians’ members were deported for conflict of interest was similar during the two periods (30 versus 28, p = .482) with not any increase among academic physicians.
CONCLUSIONS:This study showed that it is possible to recruit several academic physicians without major financial conflicts of interest providing that their status could alter their assiduity.
Vignette Presentations
VP01 Effect Of Early Life Socioeconomic Status On Trajectories Of Chinese Elders Health
- Xiaoqian Hu, Xuemei Zhen, Hengjin Dong
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- Published online by Cambridge University Press:
- 12 January 2018, p. 147
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INTRODUCTION:
China, with the largest aging population which is fast increasing, faces great challenges. Increasingly, researchers are looking at the relationship between whole life conditions from birth to death and health status in old age using a life-course approach. Few researchers have paid attention to developing countries like China where early life conditions were worse than those in western countries in the early twentieth century. China has had a complex social and political history in the twentieth century. This study investigates trajectories of aging and the effects of childhood and adulthood Socioeconomic Status (SES) encompassing education, job and family condition, on oldest-elders physical health in China.
METHODS:The data used in this study was from all seven waves (1998-2014) of the Chinese Longitudinal Healthy Longevity Survey and covered 6,483 respondents aged 80 to105 years in baseline. Measuring the limitation in activities of daily living represents physical health. Group-based trajectory modeling is used to identify groups of individuals with statistically similar developmental characteristics or trajectories. Multinomial logistic regression is used to compare the differences among trajectory groups.
RESULTS:Three-group models best fit the data for males and females. Along with increasing age, there was an increase in the limitation in activities of daily living. Some groups changed gradually, while others rose rapidly. Some childhood and adulthood socioeconomic status characteristics influenced trajectory-group membership. For both genders, group one and two had similar childhood socioeconomic status, while higher adulthood socioeconomic status like jobs were associated with less favorable health status. For group three of males suffering the hardest childhood in regard to education, had stable health status instead.
CONCLUSIONS:Diversity exists among aging procedure. Childhood and adulthood socioeconomic status influence health conditions of the oldest-elders in complex ways. Education is a remarkably positive factor significantly contributing to better health status.
VP02 Are Journal Editors A Barrier To Publication Of Real World Evidence?
- Elisabeth Oehrlein, Jennifer Graff, Eleanor Perfetto, C. Daniel Mullins, Robert Dubois, Chinenye Anyanwu, Ebere Onukwugha
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 147-148
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INTRODUCTION:
Health technology assessment (HTA) bodies often rely heavily upon evidence from peer-review publications to inform their recommendations. Since journal editors attitudes likely influence the types of study designs that are accepted through the peer-review process and on to publication, journal editors serve as gatekeepers to translation of evidence, including real word evidence (RWE), into practice. Given past skepticism of RWE study designs, journal editors perceptions of and possible biases toward RWE are important to understand as they may impact dissemination and, therefore, uptake of research findings. The objective of this study was to examine current views of journal editors regarding the: (i) value of RWE studies and (ii) challenges editors face in managing, reviewing, and publishing RWE manuscripts.
METHODS:Journal editors representing general medicine (GM), specialty medicine (SM), health policy/services research (HSR) were invited to participate in a telephone interview, a survey, and an in-person, roundtable discussion.
RESULTS:In total, seventy-nine journals were approached, resulting in: 15 interviews (GM = 2; SM = 5; HSR = 8), 17 survey responses (GM = 2; SM = 6; HSR = 9) and 8 roundtable participants. RWE was viewed favorably by interviewed editors (n = 15). Characteristics of high-quality RWE manuscripts included: research question novelty/relevance, rigorous methodology, alignment of data with question, and the extent data-source advantages are optimized. Similar manuscript review processes and challenges were voiced for RWE and other study designs. HSR editors were more likely than SM or GM editors to participate, potentially indicating these researchers are more comfortable or interested in RWE. A possible study limitation was that editors favorable toward RWE may have been more likley to participate.
CONCLUSIONS:Peer-review journal editors appear to have favorable views regarding RWE studies and can be accelerators to dissemination of RWE findings. However, they do report that studies and processes could be improved. One suggested improvement included a checklist for editors to speed rejections and improve communications with authors.
VP05 Comprehensive Evaluation Of An Evolving Transcatheter Technology
- Laurie Lambert, Leila Azzi, François Désy, Maria Vutcovici, Lucy Boothroyd, Anabèle Brière, Peter Bogaty, Michèle de Guise
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 148-149
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INTRODUCTION:
Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.
METHODS:Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.
RESULTS:Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.
CONCLUSIONS:Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.
VP07 Collaboratively Modelling The Impact Of Interventions Retrospectively
- Gordon Bache, Sukh Tatla, Deborah Simpson
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- 12 January 2018, p. 149
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INTRODUCTION:
A conventional approach to communicating value is to model the budget impact of a medicine and the associated formulations in which it is available to be prescribed. However, such an approach does not demonstrate the actual realization of the proposed impact. This abstract outlines an approach to presenting retrospective data back to healthcare professionals (HCP) that blends assumptions and real-world data. For illustrative purposes, we present the results of an application of the model for subcutaneously delivered trastuzumab in an anonymized trust in Yorkshire and Humber.
METHODS:The authors developed a model that examined one calendar year (from April 2014) of redistributed sales data for both the intravenous and subcutaneous formulations of trastuzumab for every National Health Service (NHS) trust in England. A series of baseline assumptions (1) were used to model the resource impact of different formulations such as chair time, HCP time, pharmacy preparation time, consumables, wastage, and other considerations. Impacts were estimated at the individual attendance level and scaled to the caseload. These baseline assumptions could then be overwritten by the individual trust using local data.
RESULTS:The site delivered approximately 985 doses of subcutaneous trastuzumab over a period of 12 months from April 2014, which represented about 76 percent of the total number of doses delivered. Chair time is estimated to have reduced by 22 minutes per attendance, resulting in a total saving of 361hours. HCP administration time is estimated to have reduced by 23 minutes per attendance, resulting in a total saving of 378 hours based on changing 985 IV doses to SC therapy.
CONCLUSIONS:Blending real data and assumptions to provide a retrospective assessment of actual benefits realized back to HCPs is a powerful tool for demonstrating real-world value at both an individual trust and system level.
VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies
- Amr Makady, Ard van Veelen, Anthonius de Boer, Hans Hillege, Olaf Klunger, Wim Goettsch
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 149-150
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INTRODUCTION:
Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.
METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.
RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).
CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.
VP09 Arthroplasty Registers As A Tool For Health Technology Assessment
- Laia Domingo, Olga Martínez, Jorge Arias, Joan Nardi, Lluís Puig, Mireia Espallargues
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 150-151
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INTRODUCTION:
Our purpose is to present the potential for health technology assessment that arthroplasty registers may offer.
METHODS:A revision of the health assessment uses and information collected by arthroplasty registers was made. The information provided from international networks like NORE, ISAR and ICOR was also considered. Arthroplasty registers collect data of patients undergoing joint replacement surgery (mainly hip and knee) along with implant information. They provide longitudinal information useful to assess implant survival (expressed as revision rate and calculated from the primary surgery to implant revision). They also data from the surgical procedure and, more recently, a number of registries incorporate patient reported outcomes (PROMs) information.
RESULTS:Arthroplasty registers provide information from multiple perspectives:
(i) Decision-makers and healthcare providers/authorities: the comparison of revision rates by using funnel plots is a useful methodology to benchmark implants and to identify outliers, or models with significantly different revision rate in comparison to their peers. Besides, data available in registers has proven to be useful to define sets of indicators related to safety, effectiveness, efficiency, patient-centered healthcare and perceived health outcomes.
(ii) Surgeons: Some ongoing initiatives, like ODEP, aiming at providing a benchmark rating for implant survivorship, are gaining interest by professionals promoting an evidence-based clinical practice.
(iii) Industry: the large amount of data recorded so far may allow obtaining robust information of prosthesis behavior.
(iv) Patients: there is an increasing number of registers that incorporate PROMs. Moreover, a growing interest to promote patient engagement in arthroplasty decision making has been observed.
CONCLUSIONS:Long-standing arthroplasty registries have untapped potential. Beyond the assessment of implant survival, they have been consolidated as a useful tool for decision-makers, professionals, and patients. Next steps will be to promote joint analysis of national/regional registries to explore uncommon practices or new medical devices, and also to adapt to future regulations on implant traceability.
VP13 Relation Between Magnetic Resonance Imaging Use And Hip Or Knee Replacements In The Organisation For Economic Co-operation And Development
- Robert Emprechtinger
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 151-152
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INTRODUCTION:
A high degree of geographic variation in the use of medical interventions is usually considered as a sign for inappropriate use. However, the plain geographic variation has the disadvantage that the variation might also be appropriate due to differences in the regions. Hence, we conducted a more comprehensive analysis on Magnetic Resonance Imaging (MRI) use and the relationship to hip or knee replacements. We evaluated whether there is evidence that guideline recommendations regarding hip replacements and total knee replacements are being followed. Additionally, we tried to assess whether the use of MRI is related to subsequent interventions.
METHODS:We extracted recommendations of the American College of Radiology (ACR) on the use of MRI relevant to hip replacements and total knee replacements. Subsequently, we created three hypotheses on MRI for hip or total knee replacements on what to expect from the data when these recommendations are being followed.
For each hypothesis we calculated a multiple linear regression to analyze Organisation for Economic Co-operation and Development (OECD) data. This was necessary to control for other important variables that might have had an influence on the number of interventions despite the MRI use (for example, healthcare spending, or Computed Tomography (CT) use).
RESULTS:The initial results on (primary) hip replacement and secondary hip replacement were heavily influenced by outliers. After the exclusion of the outliers (Turkey and Belgium), (primary) hip replacements were related to MRI use but not secondary hip replacements. The results on MRI and (primary) hip replacement suggest that the relationship between MRI and hip replacement in Turkey is lower than in the other OECD nations.
Regarding knee replacements, we detected a relationship between the MRI use and total knee replacement. An increase of 10 MRI examinations per 1,000 population would, according to our model, result in 9.8 additional total knee replacements per 100,000 population.
CONCLUSIONS:The relationship of MRI and (primary) hip replacement hints to inappropriate use of MRI in Turkey since the data shows a substantial deviation in the relationship compared to the other OECD nations. Apart from this, we found no evidence for inappropriate use of MRI in connection with hip replacements.
However, our results suggest that MRI is inappropriately used in relation to total knee replacements. This might contribute to potentially unnecessary total knee replacements.
VP14 Screening Recommendations For Socioeconomic Disadvantages In Pregnancy
- Katharina Rosian
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- Published online by Cambridge University Press:
- 12 January 2018, p. 152
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INTRODUCTION:
In 2015, 18.3 percent of the Austrian population were at risk of poverty and social exclusion - about 211,000 (20 percent) women aged 20–39 years were affected. International studies report that poverty may lead to an increased risk of complications and pathologies during pregnancy. Further, children who grow up in poverty often have poorer long-term health outcomes.
METHODS:In order to identify recent guidelines (2011-2016) a comprehensive handsearch was conducted in the guideline databases National Guideline Clearinghouse (NGC) and Guidelines International Network (GIN). Moreover, a handsearch for systematic reviews and primary studies was conducted in PubMed.
RESULTS:Two guidelines, the British National Institute for Health and Clinical Excellence (NICE) Guideline “Pregnancy and Complex Social Factors”, as well as the Australian Health Ministers' Advisory Council (AHMAC) Guideline “Antenatal Care”, address socioeconomic disadvantages of women during antenatal care. The recommendation of the AHMAC is that pregnancy care should be offered to all pregnant women. In addition, an individual approach will help to pay particular attention to socioeconomic factors and to incorporate them in routine examinations. NICE recommends in its guideline, affected women should be supported in order to ensure adequate prenatal care. NICE also defines criteria which are used to identify pregnant women who are in greater need of support. The only identified study developed and tested a tool for the identification of patients affected by poverty. The authors of this Canadian pilot study concluded that the defined questions helped to identify socioeconomically disadvantaged persons during anamnesis without stigmatizing.
CONCLUSIONS:Due to the proven link between poverty and health risks, special attention must be paid to socioeconomically disadvantaged pregnant women. Research on non-stigmatizing instruments, which can identify vulnerable women, is of great importance. In addition to social policy measures, it is necessary to ensure that low-threshold services are available for socioeconomic disadvantaged women and their children.
VP15 A Comparison Of Reporting In United Kingdom Health Technology Assessment And Other Systematic Reviews
- Christopher Carroll, Eva Kaltenthaler
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 152-153
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INTRODUCTION:
A recent study claimed that increasing numbers of reviews are being published and many are poorly conducted and reported (1). The aim of the present study was to assess how well reporting standards in systematic reviews published in 2014 in the United Kingdom Health Technology Assessment (UK HTA) monograph series compared with the reporting in Cochrane and other “non-Cochrane” systematic reviews from the same year, as reported by Page et al. (1).
METHODS:All relevant UK HTA programme systematic reviews published in 2014 were identified. After piloting of the form, two reviewers each extracted relevant data on conduct and reporting from these reviews. These data were compared with data for Cochrane and “non-Cochrane" systematic reviews from 2014, as published by Page et al. (1). All data were tabulated and summarized.
RESULTS:There were 30 UK HTA programme systematic reviews and 300 other systematic reviews, including Cochrane reviews (n = 45). Fewer UK HTA reviews covered therapeutic and pharmaceutical topics (53 percent and 20 percent respectively) than Cochrane (100 percent and 51 percent). The percentage of HTA reviews with required elements of conduct and reporting was frequently very similar to Cochrane and much higher than all other systematic reviews: for example, availability of protocols (90 percent, 98 percent and 16 percent respectively); the specification of study design criteria (100 percent, 100 percent, 79 percent); the reporting of outcomes (100 percent, 100 percent, 78 percent), quality assessment (100 percent, 100 percent, 70 percent) and other processes; the searching of trial registries for unpublished data (70 percent, 62 percent, 19 percent); reporting of reasons for excluding studies (91 percent, 91 percent and 70 percent) and reporting of authors' conflicts of interest (100 percent, 100 percent, 87 percent). However, HTA reviews compare less favourably with Cochrane and other reviews in the assessment of publication bias and reporting overall numbers of patients in the review.
CONCLUSIONS:UK HTA systematic reviews are often produced within a specific policy-making context and cover a greater variety of topics than Cochrane reviews. This has implications for timelines, tools and resources. However, they still tend to present standards of conduct and reporting equivalent to “gold standard” Cochrane reviews and are superior to systematic reviews more generally.
VP16 Interventional Management Of Hyperhidrosis: A Systematic Review
- Ros Wade, Alexis Llewellyn, Julie Jones-Diette, Kath Wright, Stephen Rice, Eoin Moloney, Julija Stoniute, Alison Layton, Nick Levell, Gerard Stansby, Dawn Craig, Nerys Woolacott
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- Published online by Cambridge University Press:
- 12 January 2018, pp. 153-154
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INTRODUCTION:
Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature, and can significantly affect quality of life. There is substantial variation in the availability of treatments in secondary care and uncertainty regarding optimal patient management. A systematic review was undertaken to assess the clinical effectiveness of treatments prescribed by dermatologists (iontophoresis, anticholinergic medications, botulinum toxin injections) and minor surgical treatments (curettage and newer energy based technologies) for primary hyperhidrosis and identify areas for further research.
METHODS:Fifteen databases and trial registers were searched to July 2016. Pairwise meta-analyses were conducted for comparisons between botulinum toxin injections and placebo for axillary hyperhidrosis. For other treatments data were synthesised narratively due to limited and heterogeneous data.
RESULTS:Fifty studies were included in the review; thirty-two randomized controlled trials (RCTs), seventeen non-RCTs and one case series. There was substantial variation between the studies in terms of country of origin (indicating climate and population differences), interventions and methods of outcome assessment. Most studies were small, at high risk of bias and poorly reported. There was moderate quality evidence of a large statistically significant effect of botulinum toxin injections on axillary hyperhidrosis symptoms in the short to medium term (up to 16 weeks), compared with placebo. There was weak but consistent evidence for iontophoresis for palmar hyperhidrosis. Evidence for other interventions was low or very low quality. Combining the evidence and patient advisor input, we established that further research on the clinical and cost-effectiveness of botulinum toxin injections (with anesthesia) versus iontophoresis for palmar hyperhidrosis would be useful.
CONCLUSIONS:The evidence for the effectiveness and safety of treatments for primary hyperhidrosis is limited overall and few firm conclusions can be drawn. However, there is moderate quality evidence to support the use of botulinum toxin injections for axillary hyperhidrosis. A trial comparing botulinum toxin injections with iontophoresis for palmar hyperhidrosis is warranted.