Increasingly, health technology assessment (HTA) organizations have instituted mechanisms for involving patients in assessment and review processes. The reasons are obvious—to understand the “patient experience” with a disease and to ensure that patient perspectives are considered during deliberations about the value of new treatments. More recently there have been efforts to engage the public in HTAs and HTA-informed decision-making processes. However, the goals of these efforts have not been well articulated. This may be attributable to the lack of a shared definition of “the public”. The objective of this study was to develop a common understanding of the term “the public” within the context of HTA.

The following were conducted: a survey of HTA organizations; a systematic review; consultation with Health Technology Assessment international's Special Interest Group on Patient and Citizen Involvement; and a workshop comprising representatives from patient organizations, industry, and HTA bodies in Canada.

In many HTA processes, the terms “public” and “patients” are synonymous. Definitions found in scholarly articles vary and depend on the rationale for involving the public in a particular issue. Through consultations it became clear that, in the context of HTA, the definition depends on understanding what is missing from current deliberations around the value of new health technologies. There was consensus among workshop participants that: (i) “patients” and “the public” are not the same; (ii) the role of the public may be to ensure societal values are reflected in HTAs and HTA-informed decision-making processes (e.g. serving an audit function); and (iii) a legitimate definition of “the public” could be: “A non-aligned community member with no commercial or professional interest in the HTA process who is not a patient or member of a stakeholder group”.

Consensus on the use of the terms “patient” and “public” will support rigorous, evidence-based public and patient engagement in HTA. The proposed definition indicates a way forward in this debate.

Cervical cancer screening (CCS) is conducted through multiple testing modalities including Papanicolaou smears and more recently, HPV Testing. Participation in CCS is influenced by a multitude of barriers and facilitators governed by the preferences, values, and beliefs of women. This presentation will discuss the findings from a Patient Perspectives and Experiences review for a CADTH Health Technology Assessment on HPV Testing for Primary Cervical Cancer Screening.

A systematic literature search yielded 4864 citations published from 1 January 2002 to 1 November 2017. One hundred and six eligible studies were analyzed using the qualitative meta-synthesis methodology.

The social location, circumstances and resources available to women significantly influence how they negotiate the factors that influence their CCS participation. Some of the factors we identified are Emotions, Understanding Personal Risk, Logistics, and Multiple Roles of Women. In this presentation, we will discuss how these factors interact with a woman's social location to influence women's choices and preferences about engaging in cervical cancer screening. Specifically, we describe an analysis that conceptualizes social location as a balancing fulcrum, which changes the force exerted by factors acting as incentives and disincentives. Women who experience social and material deprivation may find that disincentives are harder to overcome than women who have access to ample social and material resources. More incentives in quantity and strength would tip the balance in favor of incentives and increase CCS participation. This presentation will also describe how incentives and disincentives were operationalized in the context of a patient perspectives and experiences review for a health technology assessment.

Women's decisions to participate in CCS are influenced by many factors. The way women negotiate these factors is closely related to their personal circumstances and the availability of social, material, and financial resources.

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.

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.

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.

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.

Decision-makers are increasingly recognizing the usefulness of qualitative research to inform patient-centered policy decisions, and are accordingly increasingly demanding qualitative evidence as part of health technology assessment (HTA). In the context of tight HTA timelines, a new form of evidence synthesis has emerged—rapid qualitative reviews. The need for rapidity requires either an increase in resources or, more commonly, a compromise in rigor, yet guidance on appropriate compromises for qualitative reviews is lacking.

In order to inform de novo guidance, we conducted a systematic scoping review to identify existing guidance and published examples of rapid qualitative reviews. We searched Medline and CINAHL using medical subject headings and keywords related to “rapid reviews” and “qualitative” research, and screened the 1,771 resultant citations independently in duplicate. Additionally, we searched the grey literature and solicited examples from our contacts and other evidence-synthesis organizations. We summarized included guidance and reviews using the Search, AppraisaL, Synthesis, Analysis (SALSA) framework to identify abbreviations in the review process.

We found no guidance documents specific to rapid qualitative reviews. We found one published peer-reviewed rapid qualitative review, and several more (>10; grey literature search in process) through our organizational contacts. While methods to abbreviate the process are poorly reported, an abbreviated literature search (years and databases searched) and the use of a single reviewer appear common.

A number of agencies are producing rapid qualitative reviews, however our review identifies the urgent need to develop and explore methods for the synthesis of qualitative research that balance rapidity and rigor.

There are many approaches to synthesis of qualitative studies. The GRADE-CERQual approach (Confidence in the Evidence from Reviews of Qualitative research) provides a transparent method for assessing the confidence of evidence from reviews of qualitative research. This presentation aims at giving examples of applying CERQual, presenting and discussing its strengths and limitations.

This presentation draws on practical experiences with the conduction of three qualitative systematic reviews using the CERQual approach. The reviews differ in aim and field of research.

The three CERQual reviews to be discussed in this presentation are: (i) Emergency departments and mental health patients - Purpose: Uncovering knowledge in a project on merging emergency departments to include both somatic and psychiatric patients. (ii) Parental responses to severe or lethal prenatal diagnosis – Purpose: Providing physicians with knowledge on a patient group from their daily clinical practice. (iii) Patients' experiences with home mechanical ventilation – Purpose: Disseminating important knowledge from a national project to an international audience.

CERQual strengths:

• • Presents complex and large amount of knowledge in a clear way

• • Pools knowledge from different studies into common outcome measures across studies

• • Presents an assessment of the quality and strength of outcome measures

• • The clear presentation makes it useful in decision making.

CERQual weaknesses:

• • Time consuming to conduct the reviews

• • Simplification of qualitative research, missing out on context and nuances.

CERQual represents a useful tool to facilitate the use of qualitative evidence in clinical and political decision making. CERQual is time-consuming to learn, but a useful tool to apply when learned. CERQual may encourage more uniform reporting of qualitative research, including assessment of confidence in findings. This may increase the impact of systematic reviews of qualitative studies.

The National Institute for Health Research (NIHR) is a major funder of health research in the United Kingdom. Selecting the most promising studies to fund is crucial, and external expert peer review is used to inform the funding boards. Our aim was to evaluate the influence of different kinds and numbers of peer review and reviewer scores on Board funding decisions, and how we might modify the process to reduce the workload for stakeholders.

Our mixed method study included i) retrospective cross sectional analysis of funding board and external reviewer scores for second stage applications for research funding, using Receiver Operator Characteristic (ROC) curves to quantify the influence of reviewer scores on funding decisions and ii) qualitative interviews with thirty stakeholders (funding board members, applicants, external peer reviewers and NIHR staff).

Analysis of ROC area for reviewers indicated that areas changed very little with increasing numbers of reviewers from four to seven or more. External reviewers with clinical, methodological or patient expertise all appeared to influence Board funding decisions to a similar extent. The stakeholders interviewed valued peer review but felt it was important to develop a more proportionate process, to better balance its benefit with the workload of obtaining, preparing, reading and responding to reviews. Reviews are of most value when they fill gaps in expertise on the Board. Less than four reviews was felt to be insufficient but more than six, excessive. Workload could be reduced by making reviews more focused on the strengths and weaknesses of applications and identifying flaws which are potentially “fixable”.

Stakeholders supported the need for peer review in evaluating funding applications. Our results suggest that four to six peer reviews per application is optimum, depending on the expertise needed to complement that of advisory boards.

National health research funders are accountable to the public with regard to the societal impact of the research, including health technology assessment (HTA), that they fund. Failing to do so can not only negatively affect public trust in the allocation of resources to funding agencies, but can also lead to public mistrust in science.

We present the results of reducing research waste to ensure societal responsible research, both at an international and national level. In the Netherlands, the National Organization for Health Research and Development (ZonMw) developed an analytical framework to assess its research programs, including the national HTA program.

An evaluation of 12 national funding agencies in Australia, Europe and North America demonstrated that certain processes (e.g. how research questions are prioritized or decided) are not transparent. At the international level, health funders believe that they have a joint responsibility not just to seek to advance knowledge, but also to advance the practices of health-related research and research funding. In the Netherlands, ZonMw (HTA) research programs perform well regarding addressing societal relevance (e.g. stakeholder participation) and reasonably well on scientific quality (e.g. international cooperation and knowledge sharing). Efficiency (e.g. encouraging use of existing data and systematic reviews) appears to be less well developed, while integrity (e.g. preventing publication bias) is underexposed.

Although ZonMw is doing reasonably well in terms of reducing research waste, it was concluded that more focus on societal impact assessment is needed. To do so funding agencies need to collaborate with all relevant stakeholders. This is especially relevant in the field of HTA where the ambition is to move from evidence to impact.

In 2017 the Brazilian Ministry of Health (BMH), through the Department of Science and Technology (DECIT) and in partnership with the Hospital Alemão Oswaldo Cruz (HAOC), financially supported research activities focused on health technology assessment (HTA) on topics deemed important by the BMH. The aim was to help resolve the priority health problems of the Brazilian population and to strengthen the management of the Unified Health System, within the scope of HTA.

A survey of HTA research needs was carried out in all BMH sectors through internal meetings conducted by representatives from each of the sectors. The problems and needs were then discussed, prioritized, and transformed into research lines in a workshop sponsored jointly by DECIT and the HAOC. Following this, a specific public call was made to the HTA community to comment on the prioritized research lines. The submitted research projects were then judged and selected by a committee of experts in the field. The approved projects were contracted, and when the projects were completed the results were presented and discussed by the researchers in a final seminar for representatives of the BMH technical areas.

A total of 135 research gaps were identified, of which forty-two lines of research were included in the research call after the prioritization workshop and the search for evidence in the literature. The call involved an amount of BRL one million (USD 280,442), and seventeen research projects were financed, including two systematic reviews, seven rapid reviews, and eight economic evaluations.

The promotion of research by the BMH has enabled the search for scientific evidence to support public policies and decision making in health services.

Increased capacity for utilization of Health Technology Assessment (HTA) is key to ensuring high-impact; affordable health technologies reach the people who need them most. It also enables an environment for research in access to lifesaving technologies and innovations. The number of people suffering from one or more chronic diseases is rapidly increasing and the existing systems of care are not adequately addressing this increase. Increased HTA visibility provides an opportunity for a formal connection of Health Technologies (HTs), building a new working relationship among patients and healthcare professionals, health system strengthening, engagement of patients /consumers and health care professionals for follow up on existing HTs, and assessing new Health Technology innovations.

We reviewed existing HTA literature, and hosted a meeting of fifty participants at the first HTA meeting representing different health stakeholders including patients. The meeting explored innovative synergies that addressed best practices in health policy and technological decision making, and opportunities for integrating HTA in Uganda's Health system.

Induced practical skills in coordinating a number of uncoordinated health technologies to over forty participants, an HTA strategy developed to complement national HTA initiatives and to generate information and tools to facilitate the start of hospital-based HTA initiatives in hospitals countrywide and regionally, to improve quality and efficiency of current initiatives. An HTA association, “Uganda Association of Health Technology Assessment - UAHTA” was formed, and a work plan for piloting hospital based HTA was developed.

A Health Technology Assessment (HTA) system will enable comprehensive patient-centered, integrated (as opposed to simultaneous but independent) assessment of complex health technologies. There is a need for increased capacity and partnerships towards evidence generation, and accountability measures.

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.

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.

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).

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.

The NPS MedicineWise pharmacist-delivered phone service, Medicines Line, aims to provide evidence-based medicines information to consumers. We evaluated outcomes of the Medicines Line, including common consumer inquiries and resultant decision-making, and explored consumer motivations for seeking medicines information.

The evaluation involved conducting paper-based and telephone surveys of a sample of 200 Medicines Line callers, and semi-structured telephone interviews of a subset of twenty callers. Quantitative data were analyzed using SPSS software. Qualitative data were analyzed using content analysis.

Preliminary analysis found that the majority of callers thought the Medicines Line had improved their knowledge (ninety-six percent), confidence (eighty-two percent) and decision-making (eighty-nine percent). The most common reasons for calling the Medicines Line were inquiries about side effects or medicine compatibility. The medicines most commonly asked about were antidepressants (twenty percent), analgesics (thirteen percent) and antibiotics (nine percent). Questions about sertraline accounted for thirty-six percent of antidepressant inquiries. Interview themes regarding motivations for using the service included: trust; efficiency and convenience; specialized drug knowledge; and reporting adverse drug reactions to protect others from medicine-related harm. Medicines Line was perceived to be especially useful as an alternative to family physician or specialist consultations when consumers had a non-urgent inquiry about a medicine, and as a service to provide medicines information in remote communities.

These results indicate that pharmacist-delivered medicines information telephone services are an effective and efficient way of handling medicines inquiries. Medicines information telephone services are effective in improving health literacy, by increasing callers’ knowledge and confidence to source evidence-based medicines information and improving their ability to make informed decisions about medicine use. This evaluation identified knowledge gaps in medicine side effects and antidepressant use. Identifying such knowledge gaps may be useful in informing future health professional education programs, community campaigns, and shared decision-making resources.

The Canadian Agency for Drugs and Technologies in Health (CADTH) pan-Canadian Oncology Drug Review (pCODR) plays an important role in public reimbursement decision-making for oncology drugs in Canada. This research studies the relation of positive pCODR decisions to new cancer treatment and their subsequent inclusion in Canada's public drug plans.

We studied all oncology drugs that received an approval from Health Canada and were reviewed by the pCODR from inception till 26th Sep, 2017. The data was obtained from CADTH and Health Canada. Data such as indication, submission type and date, recommendation date, final recommendation, and subsequent provincial funding status was extracted and analyzed. Impact was evaluated by analyzing the percentage of drug submissions with assessment outcome (positive recommendation rate and conditional recommendation rate) and time taken for the final decision (recommendation gap). The percentage of drugs included in public formulary after positive recommendation by pCODR (coverage rate) and the gap in days from positive recommendation to subsequent coverage in provinces (coverage gap) was also assessed.

Among 119 drugs reviewed by pCODR, the positive recommendation rate was eight percent. Nine applications comprising seven drugs for six indications received positive recommendations, and genitourinary treatments received maximum positive recommendations. The conditional recommendation rate was 52 percent; 62 applications of 45 drugs for 46 indications received conditional recommendation. Lymphoma and myeloma treatments received maximum conditional recommendations. The average recommendation gap for positive and conditional recommendations was 180 and 172 days, respectively. The coverage rate for drugs with positive recommendation was 100 percent for all provinces except 89 percent for Newfoundland and Labrador, and 67 percent for Prince Edward Island. Among the provinces, British Columbia had a maximum of 433 days and Saskatchewan has the minimum of 165 days coverage gap.

Despite Health Canada's approval, only a fraction of oncology drugs receive positive pCODR recommendation; furthermore, provincial drug plans take time to include these in the reimbursement formularies. While health technology assessment is crucial for appropriate allocation of limited resources, efforts should also be made to reduce access barriers, particularly to positively recommended oncology drugs inclusion in provincial formularies.

High quality evidence for test accuracy can be scarce. We assessed the test accuracy of two tests (Actim Partus and PartoSure) for the prediction of preterm birth. Twenty published full-text papers were included whilst conference abstracts were excluded. Since systematic reviews of diagnostic tests on other topics may need to rely on data from conference abstracts, we test whether the findings of our review would change with conference abstracts included.

Conference citations previously excluded (n=108) were re-screened for inclusion using the following criteria: i) the diagnostic test was Actim Partus or PartoSure ii) test accuracy data of preterm delivery within seven days was reported iii) the population was women with signs/symptoms of preterm labor with intact membranes. Relevant test accuracy data were extracted and used to calculate sensitivity and specificity. Pooled sensitivity and specificity for each test were run using data from full-text papers and conference abstracts combined. These values were compared with the pooled sensitivities and specificities produced for the systematic review using full-text papers only.

Preliminary pooled sensitivities of the sixteen full-text Actim Partus studies and sixteen full-texts and two abstracts were 0.77 (95% confidence interval (CI) 0.68, 0.83) and 0.76 (95% CI 0.69, 0.83) respectively whilst pooled specificities were 0.81 (95% CI 0.76, 0.85).and 0.80 (95% CI 0.75, 0.84) respectively. Preliminary, pooled sensitivities of the four full-text PartoSure studies and four full-texts and three abstracts were 0.83 (95% CI 0.61, 0.94) and 0.82 (95% CI 0.65, 0.92), respectively, whilst pooled specificities were 0.95 (95% CI 0.89, 0.98) and 0.96 (95% CI 0.94, 0.97), respectively.

Our findings suggest that the test accuracy results would not alter substantially with the inclusion of conference abstracts. However, work is ongoing to investigate how the assessment of heterogeneity and risk of bias across studies would alter given the difficulties associated with limited methodological reporting from conference abstracts.

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.

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.

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.

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.

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.

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.

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.

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.

Conceptual models (CMs) are useful tools for researchers and health technology assessment bodies to understand the interplay among environmental characteristics (e.g., health care system), patient characteristics, health behaviors, and patient outcomes. The objective of this pilot study was to elicit perspectives of patients with atrial fibrillation (AF) and health care providers (HCPs) to develop a patient-centered CM of the AF patient experience in a US-based sample.

We developed two preliminary versions of the Andersen model of healthcare utilization (standard and patient-friendly versions) based on the published literature and the help of a patient advisor. For example, instead of describing “predisposing characteristics,” the patient-friendly CM describes, “what is it about me, or other afib patients that could impact disease or outcomes;” “enabling resources” is swapped for “helpful resources,” and “perceived need” is changed to “what impacts whether I believe I need to be treated”. Five patients from an online patient community and 10 HCPs from the University of Maryland Medical System provided feedback on the preliminary models. Audio recordings of interviews were transcribed verbatim, analyzed, and findings incorporated into a revised CM.

Interviewee additions under “what impacts whether I believe I need to be treated” included: absence of symptoms and fear of experiencing an AF episode; under “helpful resources” suggested additions include resources for navigating insurer formulary/benefits. Suggested additional outcomes of interest include anxiety, bruising, and shortness-of-breath. While patients found the patient-friendly version easy to understand, HCPs required explanation of standard-version headers, for example ‘predisposing characteristics’ and ‘enabling resources’, which had been adapted in the patient-friendly version.

Soliciting input from stakeholders ensures CMs are pragmatic, reflect the real-world experiences of patients and HCPs, and incorporate variables or other considerations not currently described in published literature. Researchers can utilize CMs to aid in selection of variables for observational studies.

Clinical practice guidelines (CPGs) are an ideal implementation mechanism for promoting effective clinical practice, but without due consideration of costs they may do more harm than good and become a source of inefficiency. The Alberta Guideline Adaptation Program sought current best practice for incorporating economic information into CPGs to better leverage health technology assessment (HTA) and health economic expertise in its guideline development program.

A comprehensive, systematic review of published and grey literature was undertaken to: (i) catalogue theoretical frameworks and practical methods for incorporating economic information into CPGs and forecasting the post-implementation economic impact of CPGs; (ii) summarize current methods for evaluating the economic impact of CPGs; and, (iii) identify barriers and facilitators to incorporating economic information into CPGs.

Rigorous economic analyses were infrequently incorporated in CPG development. While a selection of guidance documents and CPG manuals published between 2001 and 2017 by leading CPG developers emphasized the health economist's role and the importance of incorporating economic evidence into CPGs, few provided adequate guidance on the best way to do this. There is no agreement on how best to monitor the economic impact of CPGs. Analysis of a sample of over 100 studies published between 2005 and 2013 identified the three main methods currently used to assess the post-implementation economic impact of CPGs: pre-test/post-test cost analyses, mapping studies, and modelled cost-effectiveness studies. The key elements of each study type were summarized and compared.

The review highlighted the under-recognized know-do gap among developers with respect to using health economics information and expertise in CPG development. It identified the advantages and potential limitations of applying health economics to CPG development, as well as areas where developers can better utilize HTA researchers and health economists to improve the quality of guidelines and better document the resource implications and feasibility of the interventions they recommend.

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.

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.

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.

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.

Early detection of primary hepatocellular carcinoma (PHC) patients with cirrhosis is critical to enhance PHC patients’ survival rates and to save medical costs. The study aimed to generate real world evidence to support the importance for early detection of PHC patients, and this evidence will contribute to a cost effectiveness analysis of the national liver cancer surveillance program.

A retrospective analysis was performed on 98,275 PHC patients with cirrhosis in the National Center Cancer Registry from 2005 to 2014, linked to the Korea National Health Insurance claims database. The hazard ratio (HR) of mortality within five years and medical costs for the patients were compared by surveillance, epidemiology, and end results (SEER) stage.

There were differences in survival rates and medical costs depending on their characteristics including sex, age at diagnosis, SEER stage and types of initial treatment of cancer. The HR of mortality within five years of the PHC patients with distant stage versus local stage was 3.36 with 95% Confidence Interval (95% CI: 3.33–3.38) which is higher than those of the patients with regional stage (HR 1.93, 95% CI: 1.92–1.95). The estimated annual medical cost was USD 38,208 with standard deviation (SD) 54,399 for localized stage but USD 16,345 (SD 42,377) for distant stage.

If PHC patients with cirrhosis were detected at early stage, their survival rates would be clinically better with a big saving for medical costs than if they were detected at distant stage. This result itself highlights that importance of the national liver cancer surveillance program. Future studies are indicated to apply these quantitative results into the cost-effectiveness analysis of the Korean national liver cancer surveillance program.

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.

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.

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.

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.