1. Convene an expert panel
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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 |
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• 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) |
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• 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
|
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• 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 |