A systematic development process for patient decision aids

Abstract

BackgroundThe original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it.MethodsOur review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported.ResultsKey features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; ‘alpha’ testing with patients and clinicians in an iterative process; ‘beta’ testing in ‘real life’ conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development.ConclusionsThe case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.

Development and evaluation of a patient decision aid for young people and parents considering fixed orthodontic appliances

“…Intervention development: An initial version of the decision aid was drafted in accordance with the International Patient Decision Aid Standards criteria (Anon, Elwyn et al, 2006, Coulter et al, 2013. The content of the FADA was informed by clinical evidence (Brin et al, 2003, Julien et al, 2013, patient experience of orthodontic treatment (Feldmann, 2014) and the findings from the interviews described above (January 2014 -March 2014) (Figure 1).…”

Fertility Preservation in Children and Adolescents With Cancer: Pilot of a Decision Aid for Parents of Children and Adolescents With Cancer (Preprint)

“…Development of the electronic DA was theoretically guided by Coulter et al [15] and the International Patient Decision Aid Standards (IPDAS), an evidence based theoretical model for effective behavioural interventions [16,17]. A review of the literature and an assessment of information needs by the FP Taskforce Steering Committee and clinicians at The Royal Children's Hospital informed the DA content.…”

Shared decision-making in rheumatology : what matters to patients?

“…The scientific literature, however, rarely discusses in detail how PtDAs are developed; and more specifically, the actual operationalization of user involvement is lacking. Many studies do not describe how and when users were involved during PtDA development (53). This first IPDAS criterion often seems to be more of a symbolic 1 statement or used to describe the participation of users (specifically patients) during evaluation of a PtDA.…”

“…In response to this omission, the IPDAS Collaboration has recently updated their evidence base with a PtDA development process model that places more emphasis on user involvement (52,53). This process model provides a stepwise approach to the careful and systematic development and implementation of PtDAs that involves patients and health professionals at several key phases (see Figure 1.2).…”

“…Therefore, it is essential to assess the barriers for implementation during development. Patients, health professionals and policy decision-makers can provide valuable insights regarding this matter, and their involvement during development is, therefore, key (31,53).…”