Table 1 Development of the PANDAs insulin PDA using the IPDAS collaboration framework[6]

1. Providing information about options

Development (content)

• The information included in the PDA was based on two criteria:

○ What do patients want to know before making a decision

○ What do patients need to know before making a decision?

• The findings from the needs assessment of the patients informed what and how much they wanted to know before making a decision

2. Presenting probabilities

Development (content)

• The "risk communication" section of the PDA was based on the decision making theories

○ Use of event rates specified by the population in period (e.g. number of people affected out of 100 people over 5 years)

○ Comparison of outcomes probabilities using the same denominator, period, scale (e.g. out of 100 people over 5 years)

○ Description of the uncertainty around probabilities (`platinum’, `gold’, `silver’ and `bronze’)

• Visual diagrams ("smiley" faces) were used in conjunction with other methods to illustrate the probabilities (words, numbers, diagram)

• `Smiley’ sticker was used to present individualised risk to patients based on their HbA1c

3. Clarifying and expressing values

Development (content)

• Values may be attributed to

○ Each treatment option (e.g. values attributed to "make no change", "more adherent to existing treatment" and " starting insulin")

○ Specific features of the treatment option i.e. the value of the procedure/process (e.g. the values associated with insulin injection)

○ Value of outcomes (e.g. the values associated with weight gain due to insulin treatment)

○ Value of probabilities (e.g. the values associated with the probabilities of gaining 6-8 lbs in weight over a year with insulin treatment).

• The PANDAs insulin PDA helped patients to clarify their own values using an explicit approach

• Patients worked through a personal worksheet in the PDA to determine how important each feature and outcome of the treatment options were to them

4. Guiding/coaching in deliberation and communication

Development (content/format)

• IPDAS quality criteria recommend that PDAs should:

○ Provide steps to make a decision

○ Suggest ways to talk about the decision with a health professional

○ Include tools (e.g. workshop question list) to discuss options with others.

• The PANDAs PDA

○ Provides a five-step systematic approach to decision making (Table 3)

○ Encourages the patient to discuss uncertainties or queries with the healthcare professionals (prompts)

○ Encourages the patient to write down their questions for the healthcare professionals

5. Disclosing conflicts of interest

Development (process)

6. Balancing the presentation of options

Development (content/format)

• PANDAs insulin PDA provided balanced information by

○ Making comparison of the positive and negative features of each option

○ Both features were presented with equal detail and in the same format (font, order, display of statistic)

• The balance of the PDA was assessed during the acceptability study by asking the patients and the healthcare professionals how balanced and fair they found the information presented

7. Using plain language (readability)

Development (format)

• The PANDAs insulin PDA used "Simply Put" plain language guideline produced by the Centre for Communicable Disease and Prevention (1999).

• The "readability" was assessed using the Readability Calculations, version 7.0 software (which includes the SMOG and FRY readability tests)

• Patients and patient education experts also reviewed the PDA

8. Basing information on up to date scientific evidence

Development (content/process)

• Where possible, clinical evidence based on systematic reviews and national or local clinical practice guidelines were used.

9. Establishing effectiveness

Evaluation