Act 2 · Understand
Design retrospective
What the study assumed, and what happened.
Sample values. Synthetic study, not real patients.
Planned against actual
Planned values come from the protocol. Actual values arrive as aggregates in the approved hospital export.
| Quantity | Planned | Actual | |
|---|---|---|---|
| Participants enrolled Số người tham gia được tuyển | 300 patients (as stated) Assumed | 300 patients (observed, exact) Learned | as planned |
| Months to complete enrolment Số tháng để tuyển đủ | 12.0 months (as stated) Assumed | 22.8 months (observed, exact) Learned | higher than planned |
| Screen-failure rate Tỷ lệ sàng lọc thất bại | 25.0% (as stated) Assumed | 35.3% (31.9% to 38.9%, 90% within-study bootstrap) Learned | higher than planned |
| Dropout over follow-up Tỷ lệ bỏ cuộc trong thời gian theo dõi | 10.0% (as stated) Assumed | 19.7% (observed, exact) Learned | higher than planned |
| SD of the primary outcome's change Độ lệch chuẩn thay đổi của kết cục chính | 1.00 % HbA1c (as stated) Assumed | 1.26 % HbA1c (1.18 to 1.35, 90% within-study bootstrap) Learned | higher than planned |
| Difference between arms Chênh lệch giữa hai nhánh | −0.40 % HbA1c (as stated) Assumed | −0.36 % HbA1c (−0.63 to −0.0852, 90% within-study bootstrap) Learned | as planned |
| Months from first enrolment to last visit Số tháng từ người đầu tiên đến lần khám cuối | 24.0 months (as stated) Assumed | 34.8 months (observed, exact) Learned | higher than planned |
| Protocol amendments Sửa đổi đề cương the visit window is widened from 2 to 7 days either side. Reason: visits outside the window were the most common protocol deviation. protocol_amendment_1.en.md#A1.2 | not stated | 1 (observed, exact) Learned | |
| Visits outside the window Lần thăm khám ngoài cửa sổ | not stated | 19 (observed, exact) Learned | |
| Screened out by C1: HbA1c between 7.5% and 10.5% at screening Bị loại theo C1 | not stated | 15.7% (13.3% to 18.5%, 90% within-study bootstrap) Learned | |
| Screened out by C2: eGFR below 45 mL/min/1.73 m² Bị loại theo C2 | not stated | 8.2% (6.3% to 10.6%, 90% within-study bootstrap) Learned | |
| Screened out by C3: Written informed consent Bị loại theo C3 | not stated | 8.0% (6.2% to 10.1%, 90% within-study bootstrap) Learned | |
| Screened out by C4: Other conditions listed in Appendix 2 Bị loại theo C4 | not stated | 3.4% (2.3% to 5.2%, 90% within-study bootstrap) Learned |