Table 4. Aligning process evaluation aims with methods, outcomes and analysis integration. Primary Aims Assessment method Outcome Analysis integration Usage Recording of consultations† Patient & clinician^ interviews MAPPIN’SDM scores† Themes identified in patient & clinician analysis frameworks Comparison between themes identified in patient & clinician frameworks Examination of themes (patient and clinician frameworks) identified within high & low MAPPIN’SDM dyad scorers† Acceptability Patient & clinician^ interviews Themes identified in patient & clinician analysis frameworks Comparison between themes identified in patient & clinician frameworks Usefulness Patient & clinician^ interviews Patient CollaboRATE questionnaire Recording of consultations† Themes identified in patient & clinician analysis frameworks CollaboRATE scores MAPPIN’SDM scores† Comparison between themes identified in patient & clinician frameworks Association between CollaboRATE & MAPPIN’SDM scores†. Examination of themes (patient and clinician frameworks) identified within high & low MAPPIN’SDM dyad scorers† Facilitators & barriers to implementation Patient & clinician^ interviews Themes identified in patient & clinician analysis frameworks Comparison between themes identified in patient & clinician frameworks Examination of themes (patient and clinician frameworks) identified within high & low MAPPIN’SDM dyad scorers† Secondary Aims Shared decision making across trial arms Patient CollaboRATE questionnaire Recording of consultations† CollaboRATE scores MAPPIN’SDM scores† Association between CollaboRATE & MAPPIN’SDM scores†. Comparison between CollaboRATE scores of intervention arm & control arm Information provision across trial arms Patient interviews, patient information questionnaire & CRF Recordings of consultations† Information from interviews, information provision questionnaire & CRF Information from recorded consultations † Descriptive comparison between control arm and trial arm † chemotherapy DESI only ^ clinician interviews in the intervention arm only Table 5: Timetable for process evaluation
Task Description (Top tasks and Sub-tasks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Trial recruitment Process evaluation Preparation Ethics and R&D Engagement with recruiting centres Data collection Patient recruitment Recording of clinical consultations (30-40, chemotherapy DESI only) 3 per month Questionnaire completion (patients) Interviews with patients (60-80) 6 per month Interviews with clinicians (12-20, intervention arm only) 1-2 per month Interview transcription Analysis and write up Develop interview analysis coding frame & preliminary analysis Interview analysis MAPPIN’SDM scoring Quantitative data cleaning & preliminary analysis Questionnaire analysis Integrated analysis Report/paper writing
2. I am tense 1 2 3 4 3. I feel upset 1 2 3 4 4. I am relaxed 1 2 3 4 5. I feel content 1 2 3 4 6. I am worried 1 2 3 4 Appendix 8 Knowledge and preference Q. Sections A1 are for women who had a decision to make about surgery or hormone blocking pills. Section A2 are for women who had to decide between chemotherapy and no chemotherapy. Breast Cancer Treatment Choices Completing the questionnaire These questions are about what matters most to you and about your understanding of the treatments available to help to treat your breast cancer, such as surgery with hormone-blocking pills or hormone-blocking pills only. Please tick the box to answer each item. Section A1. Knowing your options (surgery and hormone-blocking pills or hormone-blocking pills only) Some of these statements are true, some are false and we expect that you might be unsure sometimes. Please tick one box for each question. 1. Hormone-blocking pills are a type of chemotherapy. Unsure False True 2. Following surgery women do not need to take hormone-blocking pills. Unsure True 3. Women who have hormone-blocking pills only (no surgery) will need hospital more often than women who have surgery. Unsure False True 4. Hormone-blocking pills can stop the cancer growing and may shrink it. Unsure False True 5. who have hormone-blocking pills only (no surgery) are likely to stay alive just as long as women who have the pills and surgery. Unsure 6. If the hormone-blocking pills stop working, women may need to have surgery or a change of pills later on. Unsure False