scholarly journals coreNASH: Multi‐stakeholder Consensus on Core Outcomes for Decision Making About Nonalcoholic Steatohepatitis Treatment

2021 ◽  
Author(s):  
Elizabeth Clearfield ◽  
Veronica Miller ◽  
Joseph Nadglowski ◽  
Katherine Barradas ◽  
Jennifer Al Naber ◽  
...  
Keyword(s):  
Decision Making ◽  
Nonalcoholic Steatohepatitis ◽  
Core Outcomes ◽  
Multi Stakeholder ◽  
Stakeholder Consensus

scholarly journals coreSCD: multi-stakeholder consensus on core outcomes for sickle cell disease clinical trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ellen Tambor ◽  
Matoya Robinson ◽  
Lewis Hsu ◽  
Hsing-Yuan Chang ◽  
Jennifer Al Naber ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Delphi Panel ◽  
Core Outcome ◽  
Cell Disease ◽  
Consensus Process ◽  
Core Outcome Sets ◽  
Multi Stakeholder ◽  
Stakeholder Consensus

Abstract Background With the dramatic increase in the pipeline for new sickle cell disease (SCD) therapies in recent years, the time is ripe to ensure a robust body of evidence is available for decision making by regulators, payers, clinicians, and patients. Harmonization of the outcomes selected across interventional trials enables optimal post-trial appraisal and decision making through valid pooled analyses and indirect comparisons. We employed a structured, multi-stakeholder consensus process to develop core outcome sets (COS) for use in clinical trials of SCD interventions. Methods CoreSCD utilized a modified Delphi method adapted from the standards recommended by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. An initial list of candidate outcomes was developed through a targeted literature review and input from an 11-member advisory committee. A 44-member multi-stakeholder Delphi Panel was established and included patients and family members, advocates, clinicians, researchers, payers, health technology assessors, representatives from government agencies, and industry representatives. Patients/advocates comprised 25% of the Delphi Panel and orientation and training was provided prior to the consensus process to ensure all were prepared to participate meaningfully. Panelists completed three rounds of an online survey to rate the importance of candidate outcomes for inclusion in the COS. Summary data was provided between each voting round and an in-person consensus meeting was held between the second and third round of voting. Consensus rules were applied following each round of voting to eliminate outcomes that did not meet predetermined criteria for retention. Results Consensus was reached for two core outcome sets. The final COS for trials of disease-modifying therapies includes ten outcomes and the COS for trials of acute interventions includes six outcomes. Both core sets include clinical outcomes as well as outcomes related to functioning/quality of life, resource utilization, and survival/mortality. Conclusions Use of the COS in clinical development programs for SCD will help to ensure that relevant, consistent outcomes are available for decision making across the product lifecycle.

A Multi-Stakeholder Consensus-Driven Research Agenda for Better Understanding and Supporting the Emotional Impact of Harmful Events on Patients and Families

2018 ◽  
Vol 44 (7) ◽  
pp. 424-435 ◽  
Author(s):  
Sigall K. Bell ◽  
Jason M. Etchegaray ◽  
Elizabeth Gaufberg ◽  
Elizabeth Lowe ◽  
Madelene J. Ottosen ◽  
...  
Keyword(s):  
Research Agenda ◽  
Emotional Impact ◽  
Multi Stakeholder ◽  
Stakeholder Consensus

scholarly journals Stakeholder consensus for decision making in eye-gaze control technology for children, adolescents and adults with cerebral palsy service provision: findings from a Delphi study

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Petra Karlsson ◽  
Tom Griffiths ◽  
Michael T. Clarke ◽  
Elegast Monbaliu ◽  
Kate Himmelmann ◽  
...  
Keyword(s):  
Decision Making ◽  
Cerebral Palsy ◽  
Delphi Study ◽  
Eye Gaze ◽  
Support Network ◽  
Advisory Panel ◽  
Gaze Control ◽  
Control Technology ◽  
Adolescents And Adults ◽  
Stakeholder Consensus

Abstract Background Limited research exists to guide clinical decisions about trialling, selecting, implementing and evaluating eye-gaze control technology. This paper reports on the outcomes of a Delphi study that was conducted to build international stakeholder consensus to inform decision making about trialling and implementing eye-gaze control technology with people with cerebral palsy. Methods A three-round online Delphi survey was conducted. In Round 1, 126 stakeholders responded to questions identified through an international stakeholder Advisory Panel and systematic reviews. In Round 2, 63 respondents rated the importance of 200 statements generated by in Round 1. In Round 3, 41 respondents rated the importance of the 105 highest ranked statements retained from Round 2. Results Stakeholders achieved consensus on 94 of the original 200 statements. These statements related to person factors, support networks, the environment, and technical aspects to consider during assessment, trial, implementation and follow-up. Findings reinforced the importance of an individualised approach and that information gathered from the user, their support network and professionals are central when measuring outcomes. Information required to support an application for funding was obtained. Conclusion This Delphi study has identified issues which are unique to eye-gaze control technology and will enhance its implementation with people with cerebral palsy.

scholarly journals Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting

2020 ◽  
Author(s):  
Katharina M Lang ◽  
Kathryn L. Harrison ◽  
Paula R. Williamson ◽  
Brian J.P. Huntly ◽  
Gert Ossenkoppele ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Face To Face ◽  
Outcome Set ◽  
Multi Stakeholder ◽  
Stakeholder Consensus ◽  
Acute Myeloid

Abstract Background Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area. The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy. In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia. Methods The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings. The Delphi survey will reduce the preliminary outcome list to essential core outcomes. After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia. Discussion The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.

Ripensare gli indicatori per le politiche per l’innovazione attraverso il Design-thinking

2021 ◽  
pp. 149-161
Author(s):  
Mauro Lombardi
Keyword(s):  
Decision Making ◽  
Design Thinking ◽  
Implementation Process ◽  
Decision Making Process ◽  
Global Order ◽  
Multi Level ◽  
Multi Stakeholder ◽  
Different Levels ◽  
Systemic View

The final chapter contains the proposal to rethink the policies for innovation based on the approach defined Design thinking. Particularly important is the introduction of concepts such as global order parameters, referring to a systemic view of the techno-economic dynamics, and of a complementary methodology, called Agile. Based on the proposed framework, the decision-making space of different actors (private, public) in pursuing objectives at different levels is then analyzed. In this way a multi-level and multi-stakeholder decision making process can be enriched through a multiplicity of indicators in order to timely verify the efficiency of implementation process.

scholarly journals Orthogonal strategy based computer-mediated negotiation: Principles and example

2018 ◽  
Vol 46 (6) ◽  
pp. 1036-1060
Author(s):  
Cahyono Susetyo ◽  
Harry Timmermans ◽  
Bauke de Vries
Keyword(s):  
Decision Making ◽  
Computer System ◽  
Indifference Curve ◽  
Decision Makers ◽  
Second Phase ◽  
Face Negotiation ◽  
Computer Mediated ◽  
Decision Making Processes ◽  
Multi Stakeholder ◽  
Optimum Solution

Previous efforts to improve stakeholders’ involvement in planning and decision-making processes mostly put planners and decision makers as the ones who decide which solution is the best for the decision problems. In bottom-up planning and decision-making processes that supposedly involve stakeholders as much as possible, the most common practice is that when stakeholders have different preferences about the decision issues, supra decision makers such as planners and experts gather stakeholders’ preferences, and then, using their expertise and experience, decide what is the best choice for stakeholders. We approach the involvement of stakeholders in planning and decision-making not by relying on planners’ expertise but from a negotiation perspective. Previous works related to stakeholders’ negotiation mostly require stakeholders to engage in a face-to-face negotiation that seldom involves a computer system to improve the process. In this paper, we develop a negotiation system to support multi-issue and multi-stakeholder decision-making problems. In our approach, stakeholders do not directly interact with each other. Their proposals are submitted to a system that produces counter-proposals to reduce the differences among stakeholders’ proposals. Therefore, stakeholders do not exchange their preferences directly, but rather preference elicitations are mediated by the system. This approach is called computer-mediated negotiation. The system itself is based on the principle of an orthogonal strategy. Our computer-mediated negotiation protocol consists of two main phases. The first phase is the preference elicitation phase, which measures stakeholders’ utility functions. The second phase is the e-negotiation phase, in which stakeholders make their proposals and the computer system provides suggestions to improve them. To simulate real-world negotiations where stakeholders make proposals and counter-proposals in a series of negotiation rounds, we implemented the indifference curve approach to enable stakeholders to make incremental changes of their proposals during negotiation. The results from our experiment suggest that our method can produce an optimum solution for a multi-issue and multi-stakeholder decision problem by moving stakeholders’ proposals closer to one another.

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