Table 1 Template for Documenting PtDA Development Process

1.

Scope

a. Described health condition or problem

b. Stated the decision that needs to be considered

c. Specified target audience.

d. Explicitly identified guiding theoretical framework, if applicable

2.

Steering Group

a. Included patients, clinicians, other experts (patient educators, shared decision making expertise, policy makers, others)

b. Membership clearly identified including credentials

c. Conflict of interest identified, if applicable

3.

Design

a. Elicited patients’ views on patients’ information and decision support needs (reported method)

b. Elicited clinicians’ views on patients’ information and decision support needs (reported method)

c. Described format (media and format) with rationale

d. Described intended setting

e. Explicitly described timing of introduction into patient pathway, how and when decision aid will be distributed to patients and/or clinicians)

f. Appraised and summarized quality of clinical evidence relevant to the decision and options, described methods for evidence review

g. Described prototype development

4.

Alpha testing (comprehensibility and usability)

a. Reviewed by patients / family members

b. Reviewed by clinicians

c. Reviewed by other experts (specify: ____)

5.

Beta testing in “real world setting” (feasibility)

a. Data collected on patients’ experience of using PtDA

b. Data collected on clinicians’ experience of using PtDA

c. Peer review by experts external to development process