VALIDATE

Faculty

The members of the VALIDATE faculty are (you can also find short biographies and pictures on our website): 

• Bart Bloemen MSc, lecturer and PhD candidate, Radboud University Medical Centre, Division of Health Technology Assessment
• Wija Oortwijn PhD, senior researcher, Radboud University Medical Centre, Division of Health Technology Assessment
• Gert Jan van der Wilt PhD, Head and professor, Radboud University Medical Centre, Division of Health Technology Assessment
• John Grin PhD, professor of Policy Sciences and System Innovation, University of Amsterdam
• Iñaki Gutierrez Ibarluzea PhD, Coordinator of Early Warning and Alert System on New and Emerging Technologies, Basque office for Health Technology Assessment, OSTEBA
• Bjørn Hofmann PhD, professor, Norwegian University of Science and Technology (Gjøvik), and the Centre for Medical Ethics at the University of Oslo
• Dario Sacchini MD PhD, professor, Catholic University of the Sacred Hearth, Institute of Bioethics (Rome)
• Pietro Refolo PhD, Adjunct professor and Research Fellow at the Catholic University of the Sacred Hearth, Institute of Bioethics (Rome)
• Laura Sampietro-Colom MD PhD, Deputy Director of Innovation and Head of the Health Technology Assessment Unit at Hospital Clinic of Barcelona
• Lars Sandman PhD, professor, Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis, and the National Centre for Priority Setting in Health Care

 

Background and objectives of the VALIDATE e-learning course

Background

Healthcare technologies are being developed at an unprecedented rate. Especially the combined use and convergence of Nanotechnology, Biotechnology, Information technology and Cognitive science  (‘NBIC’) results in entirely novel approaches to the prevention, diagnosis and treatment of disease. At the same time, this development gives rise to complex questions concerning the nature and meaning of human life and the sustainability and equity of healthcare systems.

Health Technology Assessment (HTA) has evolved to allow for informed decision making on the responsible use of healthcare technology. Current approaches to HTA involve the empirical assessment of the safety, clinical and cost-effectiveness on the one hand, and  an inquiry into the wider ethical, legal and social issues on the other hand. This shows that in HTA, empirical evidence (facts) and (ethical) values both play an important rule. In fact, HTA produces what have been called mixed claims: empirical claims that contain elements that are defined in a way that presupposes some moral, prudential, political or aesthetic judgment about those elements. This has a number of important consequences for the conduct of HTA and for the interpretation of its results. In this course, it will be argued that the relation between facts and values in HTA is one of relevance: our commitment to values such as avoiding harm, relief of suffering, respect for human life and justice define the nature of the facts about a health technology that need to be explored in the context of an HTA. Clearly, different stakeholders can have different views on the meaning and importance of such values. Such differences need to be acknowledged and explored in the context of HTA, in close interaction with empirical inquiry. The focus of the e-learning course  “VALues In Doing Assessments of healthcare TEchnologies (VALIDATE)” is on methods and approaches that can help to achieve this.

The course should be of interest to those who are familiar with the basic theory and methods of HTA (e.g. systematic reviews, cost-effectiveness models), and who wish to deepen their understanding of the policy and societal context of HTA, the role of stakeholders in technology assessment, and the interplay between facts and values in identifying the relevant questions and evidence to be addressed in an assessment. As will become clear during the course, VALIDATE aims to complement current approaches to HTA, not to substitute them. It provides a framework in which currently widely used methods such as cost-effectiveness analysis still have a prominent place, but are complemented with a number of methods that are currently less widely used and less familiar in HTA. The framework aims to clarify how these methods are related to one another, and to help HTA researchers decide what method or combination of methods is most appropriate in concrete cases.

Objectives

Participants of the VALIDATE e-learning course will improve their ability to:

• Explain the normative nature of HTA and the relation between empirical analysis and normative inquiry
• Use concepts and methods from policy science that are relevant to HTA
• Identify policy relevant questions to be addressed in an assessment, by using a typology of policy problems (i.e. well, moderately, and ill-structured policy problems)
• Choose an appropriate type of policy analysis to address these policy relevant questions
• Explain how stakeholders’ commitments to underlying values and assumptions affect their initial definition of a health problem and its potential solutions, by using the method of reconstruction of interpretive frames
• Critically appraise background theories of stakeholders
• Use ethical argumentation models to evaluate underlying normative statements and values of stakeholders
• Decide on the appropriate scope of an HTA

Target audience and required prior knowledge

Target audience

VALIDATE is aimed at students enrolled in curricula on HTA, health policy and management, health sciences and biomedical sciences in EU member states to become next generation HTA experts. PhD students and researchers working on projects related to HTA and / or the evaluation of health technologies and policy, and who wish to broaden and deepen their knowledge and skills in this area, are also cordially invited to participate in the VALIDATE e-learning course.

Required prior knowledge

Upon entering the VALIDATE program, participants preferably have basic knowledge and skills in the area of HTA, evidence-based medicine and biomedical sciences.

Language requirements

A sufficient level of proficiency in English is required. Applicants with a Bachelor’s degree from a Dutch research university are not required to prove English proficiency. Applicants who are native speakers (Australia, Canada- with exception of Quebec -, Ireland, New Zealand, Singapore, UK, USA and South Africa) are not required to prove their English proficiency. All other applicants must provide proof of English proficiency for enrolment by taking any of the following language tests (or an equivalent proof of English profiency, i.e. another acknowledged English profiency certificate or relevant work experience):

• Test of English as a Foreign Lanuage (TOEFL) test score of ≥ 575 (paper based) or ≥ 90 (internet based); https://www.ets.org/toefl
• International English Language Testing System (IELTS) band score of ≥ 6.5; this test can be taken online, and the academic writing and listening part can be automatically graded: www.oxfordenglishtesting.com
• Cambridge Certificate of Advanced English (CAE) or Certificate of Proficiency in English (CPE) marked C or higher

Registration procedure

To apply for participation in the VALIDATE e-learning course, please fill out the registration form at the VALIDATE website: www.validatehta.eu/course-registration. Application needs to be accompanied by a BSc / MSc degree certificate (‘diploma’), certified list of grades, and (if needed) proof of English proficiency. The VALIDATE faculty will evaluate whether a candidate meets the entry requirements. Upon acceptance of the application, the participant will be informed about a user account to gain access to the e-learning course.

Schedule and study load

Schedule

The VALIDATE course material consists of three full-time weeks, and one final assignment of 48 hours:

Week 1: The need to answer policy relevant HTA questions

• Introduction: HTA as policy analysis
• Day 1: General introduction and bird’s eye view of the course
• Day 2: Deciding on what it is that we need to know about a specific healthcare technology
• Day 3: Well-structured and ill-structured policy problems
• Day 4: Choosing an appropriate type of policy analysis
• Day 5: The context of HTA and ill-structured policy problems

Week 2: HTA and interpretive frames

• Day 1: Introduction to week 2: HTA and interpretive frames; the method of reconstructing interpretive frames
• Day 2: Critical frame analysis: critical analysis of background theory
• Day 3: Choosing the right approach for the different types of policy problems – contested knowledge
• Day 4 & Day 5: Choosing the right approach for the different types of policy problems – contested values

Week 3: Ill-structured problems and interactive HTA

• Day 1 & Day 2: Introduction to week 3; HTA and ill-structured policy problems
• Day 3: Deciding on the appropriate scope of an HTA
• Day 4: Validity and relevance
• Day 5: Recap, summary of the course

Week 4: Making it work

• Introduction to week 4
• Background: population screening for lung cancer
• Final assignment: a report on population screening for lung cancer
• Final assignment: oral presentation

Although the total study load is similar to four full-time weeks, participants are free to adapt the schedule to their own availability. Only the final assignment needs to be scheduled, ensuring that all participants devote an equal amount of time in completing this assignment.

Study load

The course requires the reading and understanding of texts presented, including accompanying material, such as peer-reviewed articles, watching several movie clips explaining important concepts or introducing relevant examples and case studies, and the completion of several assignments. In addition, participants are encouraged to reflect upon the course material and to participate in discussions with fellow participants using the forum provided on the e-learning website. On average, 40 hours will be spent during each week (week 1 until week 3), and the final assignment will typically require about 48 hours to complete. The total study load of VALIDATE is: 3 weeks * 40 hours = 120 hours + 48 hours final assignment = 168 hours / 28 (1 European Credit = 28 hours) = 6 EC.

Examination

The assessment of participants consists of two individual parts: one written assignment and one oral presentation. Participants are requested to apply the knowledge and skills acquired during the course to a specific case (population screening for lung cancer).

There is a possibility to take the course without making the final assignment. But this also means that you will not receive the 6 EC assigned to this course.

Written assignment (70% of final grade)

Participants are requested to write a report that should help policy makers reaching a decision on whether some form of population screening for lung cancer should be implemented in their jurisdiction, using the various concepts and methods that have been introduced in the course.

The report should be written in English (UK style), and is independently graded by two members of the VALIDATE faculty based on the following criteria, using a rating scale of 1-5 per criterion (unacceptable, poor, good, very good, excellent):

1. Does the report answer the policy question and related research question(s)?
2. Does it show a clear understanding of the concepts and methods that have been introduced in the VALIDATE course?
3. Does the report provide relevant and valid arguments that support the conclusions and recommendations made on population screening for lung cancer? Does the argumentation refute the most common objections?
4. Does the report adequately describe what sources of information have been used, how they are searched, accessed, evaluated, and synthesized?
5. Does the format of the report satisfy the requirements?
6. Is the report written in a well-structured and attractive way?
7. Are the results clearly presented? Do findings follow logically from, and are they justified by, the data analysis? Are findings based on carefully described assumptions and rationale?
8. Are conclusions linked to the findings? Are conclusions clear, clustered and prioritised?
9. Are the recommendations linked to the conclusions? Are they fair, unbiased by personal or stakeholders’ views, and sufficiently detailed to be operationally applicable? Are they clustered and prioritised?

Oral presentation (30% of final grade)

Participants will also be asked to present, and defend, their findings on lung cancer screening in an oral presentation (of approximately 10 minutes, there will also be room for a discussion of approximately 10 minutes), either at one of the VALIDATE partner institutes or via Skype. The presentation should be conducted in English, and is independently graded by two members of the VALIDATE faculty.

Final grade

The final grade is calculated by a weighted average of the written assignment (70%) and oral presentation (30%) scores. In order to pass the course examination, both components that are included in the final grade should be graded 5.5 or higher (on a scale from 1-10).

Resit

In case the report is graded lower than a 5.5, the participant should submit an improved version of the report via info@validatehta.eu.

In case the oral presentation is graded lower than a 5.5, the participant should contact the VALIDATE faculty (via info@validatehta.eu) to schedule a new presentation.

Evaluation

After completing the course, the participant will be asked to fill out an evaluation form to gather feedback on the VALIDATE course, see whether learning objectives were reached, and collect suggestions for improvement.