Dunja Dreesens

174 or to support and/or improve patient decision making which may or may not take place during a clinical encounter 15 . Yet these patient-centred knowledge tools are subject to a multitude of varying definitions and criteria, especially regarding the patient versions of guidelines, and the development process 16-22 . As a result, it is difficult for parties to distinguish what is truly important from what is not, or what type of patient-directed knowledge tool is in fact the correct means to achieve the stated purpose. In addition to quality criteria, the need for national governance is also felt strongly, as many initiatives by patient organisations and professional bodies to develop patient-directed knowledge tools exist side by side. This situation has resulted in an uncoordinated, partly overlapping mixture of publicly and privately/commercially available patient decision aids 23 . Moreover, some of the patient decision aids do not seem to follow the rigid and multi-stakeholder methods to review the evidence base, as is common in clinical practice guidelines. A guidance for the development of reliable patient versions of guidelines and patient decision aids can serve to integrate all existing knowledge and previously developed expertise, allowing the stakeholders to work together more effectively and more efficiently. The purpose of such a guidance is to promote the development of high-quality, reliable and publicly available patient- directed knowledge tools, which will contribute to achieving properly informed patients and shared decision-making. Initiated by the National Health Care Institute of the Netherlands, a consortium of healthcare stakeholders started to develop such guidance , supported by academic researchers. Apart from validity, feasibility was important given the conflict between the aim of high-quality knowledge tools and the limited resources to develop such tools. The purpose of this article is twofold. First, we describe the methods used for arriving at the guidance as an illustrative example of how formal support from national stakeholders can be reached. Second, we present the list ( guidance ) of minimum quality criteria for the development, content and governance of patient information on guidelines and patient decision aids, as well as the way in which these tools can be connected to the clinical practice guidelines. Methods The National Health Care Institute of the Netherlands initiated and granted this 12-month development study, that was composed of a literature review, a feasibility check, and a consensus procedure. We took the position that we needed various types of input and processes to ensure a successful consensus process. To this end, we designed a consortium (see first four authors and last two authors) that worked together continuously in an iterative process using cross-fertilisation, without being hindered by hierarchy. A representative of the Dutch Federation of Patients’ Organisations (last author) was co-leading the project with the first author. In a 12-month project that started in October 2015, we worked on the basis of four work packages (WPs): WP1/ Radboud University (MF) reviewed existing criteria in the literature, synthesising evidence and best practices; WP2/ Maastricht University (TvdW, DD), the coordinating group, developed the drafts of the guidance; WP3/ NIVEL (NB) safeguarded Valorisation chapter