bluuebunny/crossref_metadata_2025 huggingface dataset:
OP11 Findings From The 2017 Health Technology Assessment International Asia Policy Forum Survey
Authors: Mundy Linda , Trowman Rebecca , Kearney Brendon
Published: January 2019

Introduction:

Health systems in the Asia region seek to achieve universal health care (UHC) by increasing access to essential healthcare services, while reducing health inequalities and out-of-pocket expenditure. With this in mind, the discussion for the 2017 Health Technology Assessment International (HTAi) Asia Policy Forum (APF) centered around the topic of ‘Universal Healthcare in the Asia Region: Overcoming the Barriers using HTA and Real World Data’.

Methods:

As part of the background paper prepared to inform discussions at the APF, attendees from public sector HTA agencies from nine countries, and industry attendees from eight companies, were surveyed to explore issues on the barriers and challenges of establishing UHC in the region and use of real world data (RWD).

Results:

Most countries used evidence-based decision-making when considering which technologies to add to healthcare benefit packages; however, this was at times inconsistently applied. Prioritization criteria included burden of disease, unmet clinical need, clinical effectiveness, cost effectiveness and affordability. The political agenda and deference to expert opinion also played a role. Although all countries reported using RWD to inform decision-making, they also reported issues including lack of capacity, poor quality data and lack of collaboration between private and public sectors, as well as a conservative approach to data-linkage. It became apparent that a disconnect had been identified, as industry overwhelmingly identified access to RWD in the region as a major issue.

Conclusions:

Discussing the differences in opinion between HTA agencies and industry led to a greater understanding of issues in the Asia region, and will lead to increased dialogue and opportunities to collaborate in the future. Building capacity in the region will assist countries to deliver on their goal of achieving UHC.
OP18 A Patient And Caregiver-Designed Framework For Managed Access Programs
Authors: Young Andrea , Menon Devidas , Street Jackie , Al-Hertani Walla , Stafinski Tania
Published: January 2019

Introduction:

Reimbursement decisions on orphan drugs carry significant uncertainty, and as the amount increases, so does the risk of making a wrong decision, where harms outweigh benefits. Consequently, patients often face limited access to orphan drugs. Managed access programs (MAPs) are a mechanism for managing risk while enabling access to potentially beneficial drugs. Patients and their caregivers have expressed support for these programs and see patient input as critical to successful implementation. However, they have yet to be systematically involved in their design. The objective of this study was to explore what a framework for MAPs might look like when designed by patients and caregivers.

Methods:

Building upon established relationships with the Canadian Organization for Rare Disorders, the project team collaborated with patients and caregivers using the principles of participatory action research. Data were collected at two workshops and analyzed using a thematic network approach.

Results:

Patients and caregivers identified six aspects of an ideal MAP relating to accountability (program goals), governance (program-specific committee oversight; patient input; international collaboration), and evidence collection (outcome measures and stopping criteria; ongoing monitoring and registries). Additionally, patients and caregivers recognized that health care resources are finite and considered disease or drug eligibility criteria for deciding when to use a MAP (e.g. drugs treating diseases for which there are no other legitimate alternatives).

Conclusions:

A patient and caregiver-designed framework was created, which emphasized patient involvement and transparency. Further research is needed to examine the feasibility of this framework and roles for other stakeholders.
OP24 Sensitizing Researchers And Developers For Patient Needs And Value
Authors: Holtorf Anke-Peggy , Sandhu Gurmit , Dresler Martina
Published: January 2019

Introduction:

Valuable health technologies must improve health and well-being of patients. For sensitizing healthcare industry stakeholders for the unique perspective and values of patients we developed a workshop format including both knowledge transfer and experiential modules.

Methods:

The one-day pilot workshop was attended by two patient representatives and multidisciplinary participants from the healthcare industry (n=12) who wanted to learn about patient involvement in health technology assessment (HTA) and healthcare decision making and the implications for product development. Three content sessions covered key aspects of HTA and patient engagement and each was followed by an session which aimed at discovering the values of participants as healthy individuals or when the diagnosis of a disease and the subsequent therapy decisions (including potential clinical trial participation) impact quality and length of life. The workshop concluded with the participants prioritizing their expectations for innovation and HTA as patients or as citizens.

Results:

Overall, participants rated the workshop as excellent or good for knowledge and experiential sessions. Integration of both learning modalities was described as innovative, useful, and enjoyable. Participation in the clinical trial session triggered cognitive responses among the industry participants due to a strong focus on advancement of science for innovation. Otherwise, the responses of the industry participants matched those of the patient representatives well. Overall, patient perspectives were considered useful to enrich the value perceptions beyond those of industry. Emotions describing the personal experiences included despair, shock, anger, guilt, hope, and the will to live. As citizens, they emphasized expectations such as finding solutions, remaining independent, enjoying life and “giving back”.

Conclusions:

Innovative learning structures integrating rational and emotional aspects can allow researchers, marketers, or other stakeholders from the life-science industry to better understand patient perspectives. The format may be well suited for team building and alignment of team values around patient-needs.
OP37 Health Technology Assessment Impact Assessment: Barriers And Enablers Perceived By Members Of The International Network Of Agencies For Health Technology Assessment (INAHTA)
Authors: Berndt Nadine , Schuller Tara , Aleman Alicia , Macpherson Karen , Myles Susan , Perleth Matthias , Werkö Sophie , Hailey David
Published: January 2019

Introduction:

Health technology assessment (HTA) agencies wish to ensure the impact of their HTAs. HTA impact assessment measures the influence of a HTA on decision-making and downstream to patient outcomes. Despite their potential to provide insights, the use of impact assessment frameworks by HTA agencies is limited. Understanding the underlying mechanisms of adopting HTA impact assessment frameworks is therefore important. Using a social cognitions lens, this study aims to provide insights into the enabling and hindering factors associated with the assessment of HTA impact by INAHTA members.

Methods:

Using an interpretive description design, this cross-sectional study used semi-structured interviews of INAHTA members to gain insight into attitudes, social support, self-efficacy, barriers, and intentions towards HTA impact assessment. Transcriptions were analyzed using a social cognitions lens by two researchers using a constant comparative method to identify themes.

Results:

Twenty-six of forty-seven INAHTA members participated. Preliminary results showed that interviewees most often perceived support for assessing impact from their ministry of health or from agency staff. Most interviewees noted challenges to measuring impact at the right time and a lack of human resources, methods, and tools as internal barriers. A lack of transparency and a limited impact assessment culture were perceived as the main external barriers. Interviewees reported feeling fairly confident in overcoming internal barriers, but were less confident in overcoming external barriers. Providing feedback for improvement to HTA processes and making achievements visible were the most frequently reported advantages of assessing impact, whereas its time consuming nature was the biggest disadvantage.

Conclusions:

This is the first study to use a social cognitions model to understand HTA impact assessment. Although the results of this convenience sample need to be interpreted with caution, they contribute knowledge on factors that facilitate and hinder agencies in the assessment of impact and illuminate opportunities for developing effective strategies to support HTA agencies in this area.
OP62 Economic Evaluation Of A Provincial Back Care Pathway
Authors: Woodhouse Linda , Khan Hameed , Wolfaardt Ulrich , Slomp Mel , Lei Vivian (Yu)
Published: January 2019

Introduction:

The high prevalence, disability, and work absenteeism associated with back pain make it the single most costly musculoskeletal health condition in developed countries. However, the majority of back pain has no identifiable pathological cause and resolves without surgery or imaging. This paradox suggests that we need to change how back pain is managed to reduce unnecessary burden to individuals and the healthcare system. This study evaluated the cost of a new model of early triage-based, interprofessional care for patients with back pain.

Methods:

We evaluated the outcomes and cost of implementing a provincial care pathway for early assessment of patients with back pain at three sites: (i) adjacent to an emergency department in a community hospital; (ii) co-located with an orthopedic surgeon's clinic in a hospital; and (iii) in a primary care network (PCN) with private practice physiotherapists and chiropractors. Time-driven activity-based costing (TDABC), in combination with discrete event simulation, was used to estimate costs.

Results:

Costs were significantly lower in the models that used hospital-based physiotherapists and in the PCN model that used private practice physiotherapists and chiropractors to triage patients. These costs ranged from CAD 20 (USD 16) to manage patients identified with low severity back pain to CAD 175 to 200 (USD 137 to 156) for those with moderate to severe back pain. Models that implemented the care pathway using family physicians and surgeons to review non-surgical patients were more expensive at CAD 339 (USD 265) and CAD 514 (USD 402), respectively.

Conclusions:

New models of care that use the skills of physiotherapists and chiropractors to assess and triage patients with back pain adjacent to emergency departments and in the primary care sector are cost effective, compared with traditional physician-led models. The overarching intent is to use these data to enable evidence-informed policy and practice changes, so that more appropriate and cost-effective care is provided to patients with back pain.
OP71 Evidence Grading Systems Used In Health Technology Assessment Practice
Authors: Corabian Paula , Tjosvold Lisa , Harstall Christa
Published: January 2019

Introduction:

To facilitate moving from research findings to conclusions when conducting systematic reviews (SRs) and health technology assessments (HTAs), evidence grading systems (EGSs) have been developed to assess the quality of bodies of evidence and communicate (un)certainty about the effects of evaluated technologies. Use of EGSs has become an essential step in conducting SRs and HTAs and those relying on review conclusions should be aware of EGSs’ potential limitations.

Methods:

This study aims to identify EGSs used in SR and HTA practice, and summarize findings on their inter-rater reliability (IRR). Relevant sources were searched to identify EGSs used in recently published SRs and IRR studies of available EGSs. Members of the International Network of Agencies for Health Technology Assessment were surveyed regarding their current approaches.

Results:

Preliminary results indicate that only two conceptually similar EGSs are currently used by several organizations in SR and HTA practice: (i) the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and (ii) the Agency for Healthcare Research and Quality Evidence-based Practice Center Program (AHRQ-EPC). Both approaches emphasize a structured and transparent method. However, results from published IRR studies suggest there is a risk for variability in their application due to researchers’ diverse levels of training and experience in using them, and the complexity and heterogeneity of evidence in SRs.

Conclusions:

Validated EGSs can play a critical role in whether and how research findings are eventually translated into practice. However, our results indicate a low level of uptake of EGSs in HTA practice. Both currently used EGSs are susceptible to misuse that allows different researchers to grade the same body of evidence differently, and their performance has not been robustly explored in terms of IRR. If these results stand up to replication, one cannot rely on conclusions of published SRs, which has implications for the decisions they inform.
OP80 Reconciling Ethical And Economic Notions Of ‘Value’ For HTA
Authors: Kibel Mia , Vanstone Meredith
Published: January 2019

Introduction:

Different disciplinary frameworks in the field of Health Technology Assessment (HTA) may hold different, and potentially contradictory, assumptions about a technology's value or optimal use. For example, economic analyses may be based on outcome measures that are socially controversial or ethically problematic. This can result in economic and ethical evaluations that are difficult to reconcile, leaving HTA short of its goal to provide policy decision-makers with a holistic assessment of technology. We use the case of non-invasive prenatal testing (NIPT) to explore whether the capabilities approach can be used to align economic and ethical concepts of value in assessments of morally challenging health technologies. The capabilities approach is an economic framework which bases wellbeing assessments on a person's abilities, rather than their expressed preferences.

Methods:

To develop concepts for capabilities relevant to NIPT, we started with Nussbaum's capabilities framework, and conducted a directed qualitative content analysis of interview data from twenty-seven Canadian women with personal experience of this technology.

Results:

We found that eight of Nussbaum's ten capabilities related to options or choices that women valued in the context of NIPT, and identified one new capability, Care Taking. NIPT has a meaningful impact on women's capabilities, and capabilities concepts can capture the value of NIPT without relying on health outcomes of ambiguous social and ethical value. A capabilities approach may help reconcile ethical and economic value frameworks for NIPT.

Conclusions:

The capabilities approach can contribute to economic evaluations of morally challenging health technologies that better reflect patient preferences and ethical concerns, and may contribute to more holistic HTAs. It provides a framework within which policy analysts from diverse disciplines can communicate about the social and ethical value of morally challenging health technologies. Future research should focus on operationalizing the capabilities approach for use in evaluations of NIPT and other morally challenging health technologies.
OP82 Ethical Challenges Related To Engaging Patients And The Public In HTA
Authors: Vanstone Meredith , Bidonde Julia , Bond Ken , Abelson Julia , Schwartz Lisa , Tripp Laura , Canfield Carolyn
Published: January 2019

Introduction:

It is widely recognized that the incorporation of patient and public perspectives can enrich health policy decision-making. Methodological and practical advice on engaging patients and the public has proliferated in recent years, with many health technology assessment (HTA) agencies working to formalize their processes in this area. However, despite growing enthusiasm for patient and public engagement, many ethical issues remain unaddressed including: balancing risks and benefits to participants; recruitment methods; reimbursement for time spent participating; representation; and, information disclosure.

Methods:

In this critical analysis, we draw on our collective experiences engaging with patients and public in the context of HTA. We use principles from two theories, i) research ethics, and ii) participatory governance, to analyze these challenges. The purpose of this analysis is to explore the ways in which risks and benefits to patient and public participants might be balanced in HTA activities.

Results:

We begin by describing some ethically challenging experiences we have faced when soliciting views and values from patients and members of the public, some anticipated and some unexpected. These challenges include unexpected disclosures of information, navigating power differentials when working with vulnerable populations, eliciting information about potentially traumatizing experiences, and fairly representing controversial and conflicting opinions. We offer examples about what types of patient engagement activities may subject participants to unreasonable risk, and suggest some guiding principles to help plan ethical patient and public engagement activities.

Conclusions:

Patient and public engagement requires more than just procedural methodological expertise- it also requires the ability to identify and analyze relevant ethical issues. We posit that health technology assessors have a moral obligation to ensure that the risks of patient and public engagement activities do not outweigh the benefits. We call upon the HTA community to engage in thoughtful deliberation about what can be learned from experiences within HTA and in other contexts.
OP86 Outpatient Initial Management Of New-Onset Diabetes In Children
Authors: Larocque Brigitte , Nourrisat Alice , Rhainds Marc , Coulombe Martin , Bouchard Isabelle
Published: January 2019

Introduction:

Management of new-onset diabetes is important to achieve metabolic stabilization, minimize acute complications, and to provide insulin therapy, diabetes education and psychological support. A health technology assessment (HTA) was conducted to determine if an outpatient setting could be effective and safe for new-onset diabetes in children, and how it can be implemented in our pediatric center.

Methods:

A systematic search on initial management (outpatient versus in-hospital) of diabetes in children was performed in multiple databases and grey literature. Practice guidelines (CPGs), systematic reviews (SRs), randomized controlled trials (RCTs) and non-randomized comparative studies (NRCSs) published up to August 2017 were identified. Telephone interviews with key informants from two children's university teaching hospitals were performed to collect information on outpatient initial management models and issues related to their implementation. An interdisciplinary group of experts from our pediatric center collaborated in this project.

Results:

According to 5 CPGs, hospitalization would not be required for children without acute complications at time of diagnosis or after initial treatment of ketoacidosis if outpatient care facilities, resources, and education are available. Results from one SR and 7 NRCSs suggested that outpatient initial management is associated with good metabolic control (glycated hemoglobin) and is as safe as the inpatient care model, based on rate of hospital admissions, severe hypoglycemia, and ketoacidosis episode. However, few data regarding treatment adherence, knowledge acquisition, and emotional adaptation were identified. Outpatient education programs can be successfully provided on several consecutive or non-consecutive days after diagnosis as reported by two children's university teaching hospitals.

Conclusions:

Although data on effectiveness and safety are scarce and of low-quality, outpatient management of newly diagnosed diabetes, uncomplicated or stabilized, is recommended in children. However, data on children and their families should be collected as part of the implementation evaluation in order to enhance its efficacy and the quality of the patients’ and families’ experiences.
OP90 Do Patients With Open Fractures Need Urgent Surgery?
Authors: Mitchell Matthew D. , Williams Kendal , Mehta Samir , Fowler-Gagliardi Loriann , Thomas Julie
Published: January 2019

Introduction:

Calling in staff and preparing the operating room for an urgent surgical procedure is a significant draw on hospital resources and disrupts care of other patients. It has been common practice to treat open fractures on an urgent basis. HTA methods can be applied to examine this prioritization of care, just like they can be applied to the acquisition of drugs and devices.

Methods:

Our center completed a rapid systematic review of guidelines, systematic reviews, and primary clinical evidence, on urgent surgical debridement and stabilization of open fractures of long bones (“urgent” being defined as within six hours of the injury) compared to surgical debridement and reduction performed at a later time point. Meta-analyses were performed for infection and non-union outcomes and the GRADE system was used to assess the strength of evidence for each conclusion.

Results:

We found no published clinical guidelines for the urgency of treating open fractures. A good systematic review on the topic was published in 2012. We found six cohort studies published since completion of the earlier review. The summary odds ratio for any infection in patients with later treatment was 0.97 (95% confidence interval (CI) 0.78–1.22, sixteen studies, 3,615 patients) and for deep or “major” infections was 1.00 (95% CI 0.74–1.34, nine studies, 2,013 patients). The summary odds ratio of non-union with later treatment was 0.95 (95% CI 0.65–1.41, six studies, 1,308 patients). There was no significant heterogeneity in any of the results (I-squared = 0 percent) and no apparent trends in the results as a function of study size or publication date. We graded the strength of each of the conclusions as very low because they were based on cohort studies where the treating physician could elect immediate treatment for patients with severe soft-tissue injuries or patients at risk of complications. This raises the risk of spectrum bias.

Conclusions:

Default urgent scheduling of patients with open fractures for surgical debridement and stabilization does not appear to reduce the risk of infection or fracture non-union. Based on this information, our surgery department managers no longer schedule patients with open fractures for immediate surgery unless there are specific circumstances necessitating it.
OP91 Individual Participant Data Meta-Analysis Of Exercise Rehabilitation In Heart Failure
Authors: Ciani Oriana , Walker Sarah , Warren Fiona , Smart Neil , Piepoli Massimo , Davos Costantinos , Eames Tim , Taylor Rod
Published: January 2019

Introduction:

Traditional meta-analyses synthesize aggregate data obtained from study publications or study authors, such as a treatment effect estimate and its associated uncertainty. An increasingly important approach is the meta-analysis of individual participant data (IPD) where the raw individual-level data are obtained for each study and used for synthesis. This study compares and discusses results from an IPD meta-analysis vs standard meta-analysis of randomized controlled trials of exercise cardiac rehabilitation in chronic heart failure (CHF).

Methods:

Based on a previous systematic review, the Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH II) identified and collected IPD from randomized controlled trials (RCTs) that compared exercise rehabilitation with a non-exercise control with a minimum follow-up of six months. For this abstract, the outcome of interest was all-cause mortality. Original IPD were checked for consistency and compiled in a master dataset. Standard meta-analytic models were used for aggregate data whilst two-stage and one-stage approaches, accounting for the clustering of participants within studies, were planned for statistical analyses of IPD.

Results:

Overall thirty-three RCTs were included in the original systematic review, whereas within the ExTraMatch II project, IPD on all-cause mortality were obtained from seventeen RCTs of approximately 3,700 patients. From aggregate data there was no significant difference in pooled mortality (relative risk 0.92, 95% confidence interval 0.67 to 1.26). IPD analysis revealed 701 events across exercise and control groups. Our ongoing IPD analyses will allow us to examine how patients’ characteristics (e.g. age, New York Heart Association functional class, ejection fraction) modify treatment benefit.

Conclusions:

Given the limitations of current trial level meta-analysis evidence in CHF, access to individual data from several RCTs offers a timely and important opportunity to revisit the question of which CHF patient subgroups benefit most from exercise-based rehabilitation.
OP100 Implementing Electronic Health Record In A Children's Hospital
Authors: Andellini Martina , di Mauro Roxana , Faggiano Francesco , Derrico Pietro , Scorteccia Lorella , Ritrovato Matteo
Published: January 2019

Introduction:

The adoption of electronic health records (EHR), which contain large volumes of aggregated longitudinal clinical data, guarantees substantial benefits, including better care, improved safety and decreased clinical risks; however, it is also associated with significant costs and large technical and organizational impacts. For these reasons, it is important to conduct a comprehensive evaluation of health care delivery outcomes. The purpose of the study is to gather evidence on the safety and overall effectiveness of EHR implementation at Bambino Gesù Children's Hospital.

Methods:

A decision-oriented health technology assessment (HTA) method was applied to assess the technology on clinical, technical, organizational, economic, legal, ethical and safety domains. It is a new implementation of the EUnetHTA CoreModel integrated with the Analytic Hierarchy Process. The evaluation structure was a hierarchical decision tree filled with indicators of a technology's performance, where each indicator was weighted based on its relative impact on decision making. Finally, the alternatives’ ranking was defined. A subgroup of these indicators has been included in a checklist for the evaluation of six EHR implementation projects. This checklist was used as a tool by each involved professional during demo sessions.

Results:

The assessment took into consideration all the recommendations about the benefits and disadvantages of EHR. In particular, EHR seems to offer many benefits in terms of safety and clinical effectiveness, such as improved continuity, quality of care and accessibility of the data. Its implementation resulted in important organizational outcomes such as EHR configuration, learning curve and training; usability was the main technical characteristics of the technology taken into account. Finally, legal aspects on privacy and data security assumed a key role.

Conclusions:

A detailed technology evaluation of EHR has permitted the hospital's decision-makers to knowingly assess its introduction in the hospital.
OP109 Comparison Of The Health System Establishment Periods In Eighty-Eight Countries
Authors: Cheng Xuan , Lei Hai-Chao , Yang Yu-Jie , Fan Na-Na , Pan Yi-Ming , Huang Jia-Wen , Zhang Xu , Du En-Huan
Published: January 2019

Introduction:

Health system reform is considered a tough issue worldwide. Great efforts have been made toward health system building and strengthening. However, it is still unclear which health system is appropriate for different countries. This study aimed to systematically compare the characteristics of the establishment periods between eighty-eight counties of National Health Service (NHS) and Social Health Insurance (SHI).

Methods:

Forty-eight NHS countries and forty SHI countries with data availability were selected. The establishment years of current health systems and other eighteen indicators in economics, society, population and health during establishment periods were collected. Comparison between NHS and SHI was conducted by descriptive analysis of every indicator.

Results:

Most NHS countries were established during the cold war, while SHI had been set up since the cold war ended. The median of gross domestic product (GDP) per capita, urbanization rate and aging rate of SHI were USD 1535 in current dollars, 58.2 percent and 9.8 percent, respectively; compared with USD 1387, 41.2 percent and 4.7 percent, respectively of NHS. NHS countries had a smaller total population, lower mortality rate and elderly dependency ratio, while the birth rate and children's dependency ratio were higher. SHI countries showed a higher life expectancy and lower mortality rate in infants and children. NHS countries spent less in total health expenditure and a lower proportion of GDP. The median health expenditure per capita of SHI and NHS were USD 188 and USD 131 in current dollars, respectively. There was little difference among maternal mortality rates, and public and private health expenditure proportions.

Conclusions:

NHS and SHI countries had different characteristics during the health system establishment periods. NHS was established earlier than SHI overall, so that SHI revealed higher levels in economic and social development. Health outcomes of NHS countries were slightly lower than SHI ones, while health expenditure was more in SHI countries. Specific social, economic, demographic and health conditions should be considered when countries are building their own health systems.
OP113 Iramuteq Analysis Of Trastuzumab's Public Consultation In Brazil
Authors: Carvalho Viviane , Silva Everton , Sousa Maria-Sharmila , Sampaio Ricardo , Barreto Jorge
Published: January 2019

Introduction:

In Brazil, the “Sistema Unico de Saúde” (SUS) is a public health system that has universal coverage, comprehensive care, and principles like community participation. The incorporation, update or exclusion of new health technologies is done by the National Committee for Technology Incorporation (CONITEC), which issues reports on the incorporation of technologies and submits them to public consultations, which is the main mechanism of public involvement and an opportunity to influence the decision to access and coverage to new health technologies. Our study aimed to investigate a typology of social representations on the contributions from 2012 to the CONITEC's public consultations to the incorporation of Trastuzumab for the treatment of initial breast cancer in Brazil.

Methods:

Our study deployed a mixed-methods approach to semi-quantitatively analyze the social representativeness and corpus composition of all the public consultation contributions for the recommendation of the Trastuzumab's incorporation for treatment of initial breast cancer within SUS, as well as the authors' qualitative analysis of the IRAMUTEQ software as a potential effective and efficient tool to semi-qualitatively analyze such public consultations. All contributions were included (127 contributions, from several Brazilian states) and organized into a single corpus, which was submitted to 5 types of analyzes (classical lexical analysis, analysis of group specificities, descending hierarchical classification; similitude analysis and word cloud).

Results:

The general corpus consisted of 114 texts, separated into 685 text segments (TS), with use of 79.12 percent of total TS (684). The analyzed content was categorized into four classes: Class 1 – Patient Representations/ Advocacy (186 ST-34.3 percent); Class 2: Pharmaceutical Industry/ Advocacy (181 ST-33.4 percent); Class 3: Health Professionals (81 ST-14.9 percent); and Class 4: Individual Contributions (94 -17.3 percent). Class 1 corpus consisted mostly of contributions made from a breast cancer patient association/ advocacy report, which focused mainly on lay expertise terminology. We observed a proximity in corpus between Classes 2 and 3, showing a potential approximation between the pharmaceutical industry and health professionals' contributions, to whom the main word occurrences related to health technologies. Class 4 corpus focused on improvement and individual need, as well as in corpus referring to SUS.

Conclusions:

From our findings, we observed: (i) a potential similarity in contributions of health professionals and pharmaceutical industry; (ii) how lay expertise might affect the contributions of patients individually and within advocacy and patient organizations; and (iii) the uses and limitations of IRAMUTEQ as potentially effective and efficient tool to semi-qualitatively analyze health technology assessment public consultation contributions.
OP119 Appraising Qualitative Research For Qualitative Evidence Syntheses
Authors: Majid Umair , Vanstone Meredith
Published: January 2019

Introduction:

The growth of the evidence-based policy movement sought to determine how to better assess and incorporate qualitative evidence in clinical practice and policy development. The question engendered was not whether qualitative research is valuable but how researchers can enhance its rigor. From this discussion arose over one hundred appraisal tools for the quality appraisal process of qualitative studies. For those without a deep familiarity with the qualitative research paradigm, navigating through the breadth of tools to find the most suitable tool for the task is a cumbersome process. This presentation will review the descriptive characteristics of available quality appraisal tools for assessing the quality of primary qualitative studies in qualitative evidence syntheses (QES). This presentation will also offer a critical discussion on the use of reflexivity as a de facto quality criterion, and how methodological reporting may influence the application of quality criteria in QES.

Methods:

We conducted a systematic search to identify quality appraisal tools of qualitative research designed for use in QES. This search built upon the work of Santiago-Delefosse and colleagues by extending their search to 2016.

Results:

We identified eight appraisal tools intended for use in the quality appraisal process of a QES. We provide a description of the structure, content, objectives, and philosophies of tools followed by considerations concerning their historical antecedents, common patterns regarding structure, content, and purpose, and the implications of these patterns on the QES process.

Conclusions:

Quality appraisal of qualitative research is an important step in QES, and there have been a proliferation of tools for this purpose. By providing an overview of available tools detailing their intent and strengths, this presentation will assist those engaging in QES to choose an appropriate tool for their work.
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.