Informed consent for research has traditionally emphasized information provision over support to people making a difficult decision. We have argued that applying the shared decision making model to informed consent decisions would benefit both trial participants and trialists. Here we describe initial efforts to develop a decision aid for thrombophilic pregnant women being asked to participate in a trial testing different oral anti-coagulants.
Method:
We are employing User-Centered Design to modify a template inspired by the International Patient Decision Aids Standards (IPDAS) framework. Phase 1 of data collection involves cognitive walkthroughs with experts in computer usability (n=2), decision aids (n=2), ethical review (n=1) and the clinical content area (n=3) of a draft decision aid based on an existing trial testing low molecular weight heparin as an intervention for thrombophilic pregnant women. Cognitive walkthroughs elicited general design principles and document-specific improvements.
Result: Expert-identified design principles included 1) hyperlinking legal and technical information that can be seen to ‘clutter’ an ICD; 2) clear and concise summarization of decision options; 3) presenting advantages and disadvantages of both participation and non participation in a head to head fashion, thus facilitating direct comparisons; 4) presenting risks consistently in terms of severity and rarity; 5) Explicit exercises to clarify which advantages and disadvantages matter most; 6) eliciting further discussion by providing space to write down questions or concerns; 7) summarizing all study procedures in a table; 8) clearly differentiating procedures that are standard of care from those that are study specific; 9) Use of simplified, consistent language.
Conclusion:
The UCD approach provides a useful approach for taking IPDAS –inspired principles and turning them into a practicable and testable decision aid for potential RCT participants. Design principles identified here should be considered for any efforts to develop a decision aid for informed consent decisions.