Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions.Methods: The process followed... Show moreObjective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions.Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating whiteboard videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set.Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1-Knowledge of options, their potential benefits and harms; 2-Chosen option aligned with each patient's values and preferences; 3-Confidence in the chosen option; 4-Satisfaction with the decision-making process; 5-Adherence to the chosen option and 6-Potential negative consequences of the SDM intervention.Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set.Clinical significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.(c) 2021 Elsevier Inc. All rights reserved. Show less
Dreesens, D.; Stiggelbout, A.; Agoritsas, T.; Elwyn, G.; Flottorp, S.; Grimshaw, J.; ... ; Weijden, T. van der 2019
Objective: Patient-directed knowledge tools are designed to engage patients in dialogue or deliberation, to support patient decision-making or self-care of chronic conditions. However, an abundance... Show moreObjective: Patient-directed knowledge tools are designed to engage patients in dialogue or deliberation, to support patient decision-making or self-care of chronic conditions. However, an abundance of these exists. The tools themselves and their purposes are not always clearly defined; creating challenges for developers and users (professionals, patients). The study's aim was to develop a conceptual framework of patient-directed knowledge tool types.Methods: A face-to-face evidence-informed consensus meeting with 15 international experts. After the meeting, the framework went through two rounds of feedback before informal consensus was reached.Results: A conceptual framework containing five patient-directed knowledge tool types was developed. The first part of the framework describes the tools' purposes and the second focuses on the tools' core elements.Conclusion: The framework provides clarity on which types of patient-directed tools exist, the purposes they serve, and which core elements they prototypically include. It is a working framework and will require further refinement as the area develops, alongside validation with a broader group of stakeholders.Practice implications: The framework assists developers and users to know which type a tool belongs, its purpose and core elements, helping them to develop and use the right tool for the right job. (C) 2019 Elsevier B.V. All rights reserved. Show less
Cichutek, K.; Darko, M.; Epstein, J.; Hindawi, S.; Jivapaisarnpong, T.; Klein, H.; ... ; US Pharmacopeial Convention 2018
A considerable number of approved drugs show non-equilibrium binding characteristics, emphasizing the potential role of drug residence times for in vivo efficacy. Therefore, a detailed... Show moreA considerable number of approved drugs show non-equilibrium binding characteristics, emphasizing the potential role of drug residence times for in vivo efficacy. Therefore, a detailed understanding of the kinetics of association and dissociation of a target-ligand complex might provide crucial insight into the molecular mechanism-of-action of a compound. This deeper understanding will help to improve decision making in drug discovery, thus leading to a better selection of interesting compounds to be profiled further. In this review, we highlight the contributions of the Kinetics for Drug Discovery (K4DD) Consortium, which targets major open questions related to binding kinetics in an industry-driven public-private partnership. Show less
