scholarly journals A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines

2020 ◽  
Author(s):  
Magdalena Bujar ◽  
Neil McAuslane ◽  
Stuart Walker ◽  
Sam Salek
Keyword(s):  
Decision Making ◽  
Best Practices ◽  
Technology Assessment ◽  
Regulatory Authority ◽  
Health Technology ◽  
Good Science ◽  
Development Review ◽  
Raising Awareness ◽  
Quality Decision

Background: The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionmaking processes. Methods: The aim of this study was to evaluate the practicality of QoDoS (Quality of Decision-Making Orientation Scheme) in assessing the incorporation of ten QDMPs during the development, review and reimbursement of medicines, illustrated by case studies with a pharmaceutical company, a regulatory authority and a health technology assessment (HTA) agency. Individuals from each organisation completed the 47-item QoDoS questionnaire. Results: The results demonstrate the applicability of QoDoS in identifying favourable and unfavourable practices and in assessing the consistency and transparency of the QDMPs within each organisation, as well as across the different stakeholders. Furthermore, the study established the value of the methodology in raising awareness of the biases and best practices in decision-making, as well as having a basis for discussion for differences within and across stakeholders to promote consistency and alignment in decision-making. Finally, the QoDoS demonstrated the need for improvement across a number of decision-making practices for the 3 organisations such as the evaluation of alternatives and of the decision impact. Conclusion: The QoDoS can be used to benchmark organisations’ decision-making practices to provide a basis for discussion to ultimately encourage a level of trust across and within organisations and helping to identify areas for improvement.

EUR-ASSESS Project Subgroup Report on Methodology:Methodological Guidance for the Conduct of Health Technology Assessment

1997 ◽  
Vol 13 (2) ◽  
pp. 186-219 ◽  
Author(s):  
Alessandro Liberati ◽  
Trevor A. Sheldon ◽  
H. David Banta
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health Policy ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Policy Decisions ◽  
Health Technologies ◽  
Benefits And Costs

Health technology assessment (HTA) is primarily concerned with the consequences (benefits and costs) of health care and health policy decisions. Because decision making is complex and outcomes are often uncertain, it is helpful to attempt to assess the consequences. The quality of decisions can be improved by a process that provides a consistent framework for identifying and assessing health technologies.

CONSIDER CONTEXT AND STAKEHOLDERS

2012 ◽  
Vol 28 (2) ◽  
pp. 166-167 ◽  
Author(s):  
Laura Sampietro-Colom
Keyword(s):  
Decision Making ◽  
Best Practices ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Process Development ◽  
Health Technology ◽  
Policy Environments ◽  
Set Up

Health technology assessment (HTA) is now 35 years old (1). During this time, the science and use of HTA has evolved enormously, adapting to changing healthcare and policy environments. Today, the HTA community has strong methods and procedures to produce HTA (5–7;10), and its results are increasingly used worldwide for decision making. It seems therefore that the time has arrived to set up best practices and to benchmark HTA processes and organizations. The work initiated by Drummond et al. is highly valued, because it opens a new area of needed work following the HTA community's previous emphasis on methodological and process development.

scholarly journals Use of Evidence-Informed Deliberative Processes by Health Technology Assessment Agencies Around the Globe

2019 ◽  
Vol 9 (1) ◽  
pp. 27-33 ◽  
Author(s):  
Wija Oortwijn ◽  
Maarten Jansen ◽  
Rob Baltussen
Keyword(s):  
Decision Making ◽  
Best Practices ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Online Survey ◽  
Contextual Factors ◽  
Health Technology ◽  
Appraisal Committee ◽  
Health Technologies ◽  
Deliberative Processes

Background: Evidence-informed deliberative processes (EDPs) were recently introduced to guide health technology assessment (HTA) agencies to improve their processes towards more legitimate decision-making. The EDP framework provides guidance that covers the HTA process, ie, contextual factors, installation of an appraisal committee, selecting health technologies and criteria, assessment, appraisal, and communication and appeal. The aims of this study were to identify the level of use of EDPs by HTA agencies, identify their needs for guidance, and to learn about best practices. Methods: A questionnaire for an online survey was developed based on the EDP framework, consisting of elements that reflect each part of the framework. The survey was sent to members of the International Network of Agencies for Health Technology Assessment (INAHTA). Two weeks following the invitation, a reminder was sent. The data collection took place between September-December 2018. Results: Contact persons from 27 member agencies filled out the survey (response rate: 54%), of which 25 completed all questions. We found that contextual factors to support HTA development and the critical elements regarding conducting and reporting on HTA are overall in place. Respondents indicated that guidance was needed for specific elements related to selecting technologies and criteria, appraisal, and communication and appeal. With regard to best practices, the Canadian Agency for Drugs and Technologies and the National Institute for Health and Care Excellence (NICE, UK) were most often mentioned. Conclusion: This is the first survey among HTA agencies regarding the use of EDPs and provides useful information for further developing a practical guide for HTA agencies around the globe. The results could support HTA agencies in improving their processes towards more legitimate decision-making, as they could serve as a baseline measurement for future monitoring and evaluation.

scholarly journals HOW TO INTRODUCE MORE (OR BETTER) ETHICAL ARGUMENTS IN HTA?

2015 ◽  
Vol 31 (3) ◽  
pp. 111-112 ◽  
Author(s):  
Erik Schokkaert
Keyword(s):  
Decision Making ◽  
Technology Assessment ◽  
Good Life ◽  
Health Technology ◽  
The Good Life ◽  
Ethical Values ◽  
Health Technologies ◽  
Life Evaluation ◽  
Conception Of The Good

All evaluation exercises involve ethical values, as they require some conception of the “good life.” Evaluation of health technologies is no exception. Because there is no consensus about what is a good life, we have to devise decision-making procedures in which citizens with different opinions are heard and treated fairly (1). The purpose of health technology assessment (HTA) is to offer useful input into this process so as to increase the quality of the deliberations and of the resulting decisions. How to bring ethical values into this process?

scholarly journals Differences between health technology assessment topics in high- and middle-income countries: a scoping review

2021 ◽  
Vol 79 (1) ◽  
Author(s):  
Sepehr Ghazinoory ◽  
Basireh Majidi ◽  
Shohreh Nasri ◽  
Ehsan Zandi ◽  
Hosein Farrokhi ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Scoping Review ◽  
Technology Assessment ◽  
Policy Making ◽  
Health Technology ◽  
Awareness Training ◽  
Middle Income ◽  
Middle Income Countries ◽  
Raising Awareness

Abstract Background The Health Technology Assessment (HTA) has encountered different issues and challenges over the last two decades. The main purpose of this research is to review the issues and challenges in high- and middle-income countries through reviewing studies related to the HTA. Methods The HTA area literature of different countries was collected from 2009 to 2020 and analyzed using scoping review, based on Scopus and WoS databases. Results Given the fact that the HTA is practically done in high- and middle-income countries, the results of reviewing the studies and articles of countries reveal that high-income countries seek to increase the participation of stakeholders and enhance the transparency of processes, policy-making, and regulation of the HTA, as well as the systematization of various participant institutions in this area. Middle-income countries, on the other hand, are mostly involved in raising awareness, training and skill development of HTA-related staff, institutionalizing the concept of HTA, and allocating appropriate resources for effective and safe decision-making in their health system. Conclusion The problem of incoordination between stakeholders (participant institutions) in the HTA, and thereby, problems in decision-making were found in many of the studied reports and articles. Thus, one of the useful efforts to be made by different countries to maintain the integrity of this system would be the process of involving all members of this system and the formation of a healthy ecosystem in the HTA.

DESCRIBE DECISION-MAKING SYSTEMS, ASSESS HEALTH TECHNOLOGY ASSESSMENT REPORTS

2012 ◽  
Vol 28 (2) ◽  
pp. 168-168 ◽  
Author(s):  
Chris Henshall
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Reports

The paper by Drummond et al. in this issue of the Journal discusses how the principles that have been proposed in previous papers by these authors might be used as the basis for benchmarking health technology assessment (HTA) organizations. This raises a number of important issues, some acknowledged and discussed by the authors, and some not. The commentary by Sampietro provides an analysis of many of these. Two issues strike me as fundamental in this debate: the need for an agreed and objective approach to describing health system decision-making systems; and the need for an agreed and objective approach to the assessment of the quality of HTA reports to support specific decisions.

Why Is Safe Science Good Science?

2018 ◽  
Author(s):  
Camilla Kao ◽  
Che-I Kao ◽  
Russell Furr
Keyword(s):  
Decision Making ◽  
Design Thinking ◽  
Good Science ◽  
Safety Issues ◽  
Safety Requirements ◽  
The Arts ◽  
Hands On ◽  
Obvious Benefit ◽  
New Ideas

In science, safety can seem unfashionable. Satisfying safety requirements can slow the pace of research, make it cumbersome, or cost significant amounts of money. The logic of rules can seem unclear. Compliance can feel like a negative incentive. So besides the obvious benefit that safety keeps one safe, why do some scientists preach "safe science is good science"? Understanding the principles that underlie this maxim might help to create a strong positive incentive to incorporate safety into the pursuit of groundbreaking science.<div><br></div><div>This essay explains how safety can enhance the quality of an experiment and promote innovation in one's research. Being safe induces a researcher to have <b>greater control</b> over an experiment, which reduces the <b>uncertainty</b> that characterizes the experiment. Less uncertainty increases both <b>safety</b> and the <b>quality</b> of the experiment, the latter including <b>statistical quality</b> (reproducibility, sensitivity, etc.) and <b>countless other properties</b> (yield, purity, cost, etc.). Like prototyping in design thinking and working under the constraint of creative limitation in the arts, <b>considering safety issues</b> is a hands-on activity that involves <b>decision-making</b>. Making decisions leads to new ideas, which spawns <b>innovation</b>.</div>

Sign in / Sign up

Export Citation Format

Share Document