Table 2 The development process of the PANDAs insulin PDA

1. Convene an expert panel

UKMRC/IPDAS

• To guide the development of the PDA, including determining the clinical focus, needs assessment, research methods, content and format of the PDA, as well as evaluation and implementation

• Expert consensus (face-to-face meetings)

• Ten stakeholders were selected, including general practitioners, diabetologist, diabetes educator, expert patients, representative from Diabetes UK, patient decision support experts, statistician

• Four meetings were conducted during the one-year period

2. Assess users’ needs

UKMRC/ IPDAS

• To assess the needs of patients with type 2 diabetes who are making treatment decisions

• Individual patient and clinician interviews

• Nine patients at the point of decision making and 14 general practitioners, nurses and dieticians involved in diabetes care were interviewed

• To assess the needs of clinicians who are supporting patients’ decision making

• The users identify decisional, emotional, information and social support needs

• To determine the preferred decision support tool and its mode of delivery

• A paper-based decision support tool is preferred

3. Review the literature

UKMRC/ IPDAS

• To identify the range of effective decision support tools (general)

• Literature review

• PDA was selected as the decision support tool with the most evidence [10]

• Identify existing decision support tool for diabetes treatment (specific)

• Decision support tools were identified [Decision Aid Library Inventory http://decisionaid.ohri.ca]

4. Identify the theoretical framework

UKMRC

• To review the existing decision support theories

• Literature review

• Ottawa decision support framework was selected as it was the most used and implemented [11]

5. Collate the clinical evidence for treatment options

IPDAS

• To search, select and synthesise the evidence of the pros and cons of the treatment options

• Literature review, focusing on systematic reviews and local/national clinical practice guidelines

• There was a lack of systematic reviews on the efficacy and safety of insulin vs oral oral hypoglycaemic agents. Evidence was synthesized from cohort studies [12]

6. Drafting of the PDA (Alpha testing I)

IPDAS/UKMRC

• The design the PDA (content and format) team and PDA design expert drafted the PDA iteratively

• Draft-review-revise iterative process by the research team and PDA design experts

• The preliminary draft of the PDA was developed based on the IPDAS criteria and went through 13 iterations between the researchers and PDA design experts

7. Review by the expert panel (Alpha testing II)

IPDAS/UKMRC

• To review the PDA by the stakeholders (not part of research team)

• Expert panel consensus (meetings and emails)

• The research team and the PDA design experts discussed the feedback and agreed on the final draft for beta testing

8. Develop the PDA training module for clinicians

• To develop a training module, including a guidebook and workshop, to guide clinicians on how to use the PDA with the patients

• Expert consensus involving research team, decision support experts, diabetes educator and medical education expert

• A PDA guidebook for clinicians

• A 1-2 hour workshop involving short lectures, demonstration and feedback

9. Assess the readability

IPDAS

• To assess the readability of the PDA

• Readability Calculations v7.0 software

• The readability was at grade 8 (or English year 9) using SMOG and Fry

10. Review by patients and clinicians (Beta testing)

IPDAS

• To assess the acceptability and feasibility of the PDA in real consultations

• Patient and clinician questionnaire survey

• Nine patients and 14 clinicians found the PDA acceptable and feasible

• Individual interviews with patients and clinicians

11. Finalise the PDA

IPDAS

• To finalise the content, design and quantity to be printed

• Research team and PDA design expert consensus

• A 16-paged paper PDA was developed

• To declare conflict of interest, next update