Act 3 · Learn · F1.6
Clinician review
Confirm, correct or reject each value. A correction keeps the old value and becomes elicited.
Sample values. Synthetic study, not real patients.
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| Parameter and evidence | Value for a new study, with the comparisons | Decision |
|---|---|---|
| Tablets taken as prescribed Tỷ lệ uống thuốc đúng chỉ định 293 patients, 3 sites | 81.9% (71.7% to 88.9%, 90% prediction for a new study) Learned This study only 81.9% (81.3% to 82.4%, 90% within-study bootstrap) Learned | CorrectReject |
| Days for approval and ethics Số ngày phê duyệt và xét duyệt đạo đức 3 clinicians | 120 days (80 to 200, 90% elicited range) Elicited Global default 160 days (90 to 365, 90% published or brief range) Assumed | CorrectReject |
| Days from visit to data entry, all sites Số ngày từ thăm khám đến nhập dữ liệu, tất cả cơ sở 300 patients, 3 sites | 7 days (5 to 11, 90% prediction for a new study) Learned This study only 7 days (7 to 8, 90% within-study bootstrap) Learned | CorrectReject |
| Days from visit to data entry, central hospitals Số ngày từ thăm khám đến nhập dữ liệu, bệnh viện trung ương 231 patients, 2 sites internal only | 6 days (4 to 9, 90% prediction for a new study) Learned This study only 6 days (6 to 6, 90% within-study bootstrap) Learned | CorrectReject |
| Days from visit to data entry, provincial hospitals Số ngày từ thăm khám đến nhập dữ liệu, bệnh viện tỉnh 69 patients, 1 sites internal only | 13 days (8 to 19, 90% prediction for a new study) Learned This study only 13 days (12 to 14, 90% within-study bootstrap) Learned | CorrectReject |
| Protocol deviations per patient-month, all sites Sai lệch đề cương mỗi bệnh nhân-tháng, tất cả cơ sở 300 patients, 3 sites | 0.0487 per patient-month (0.0292 to 0.0813, 90% prediction for a new study) Learned This study only 0.0487 per patient-month (0.0425 to 0.0558, 90% within-study bootstrap) LearnedGlobal default 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed | CorrectReject |
| Protocol deviations per patient-month, central hospitals Sai lệch đề cương mỗi bệnh nhân-tháng, bệnh viện trung ương 231 patients, 2 sites internal only | 0.0395 per patient-month (0.0235 to 0.0664, 90% prediction for a new study) Learned This study only 0.0395 per patient-month (0.0337 to 0.0464, 90% within-study bootstrap) LearnedGlobal default 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed | CorrectReject |
| Protocol deviations per patient-month, provincial hospitals Sai lệch đề cương mỗi bệnh nhân-tháng, bệnh viện tỉnh 69 patients, 1 sites internal only | 0.0832 per patient-month (0.0485 to 0.14, 90% prediction for a new study) Learned This study only 0.0832 per patient-month (0.0667 to 0.10, 90% within-study bootstrap) LearnedGlobal default 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed | CorrectReject |
| Monthly dropout rate, all sites Tỷ lệ bỏ cuộc hằng tháng, tất cả cơ sở 300 patients, 3 sites | 0.0184 per month (0.0108 to 0.0315, 90% prediction for a new study) Learned This study only 0.0184 per month (0.015 to 0.0227, 90% within-study bootstrap) LearnedGlobal default 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed | CorrectReject |
| Monthly dropout rate, central hospitals Tỷ lệ bỏ cuộc hằng tháng, bệnh viện trung ương 231 patients, 2 sites internal only | 0.015 per month (0.00845 to 0.0267, 90% prediction for a new study) Learned This study only 0.015 per month (0.0112 to 0.0202, 90% within-study bootstrap) LearnedGlobal default 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed | CorrectReject |
| Monthly dropout rate, provincial hospitals Tỷ lệ bỏ cuộc hằng tháng, bệnh viện tỉnh 69 patients, 1 sites internal only | 0.0312 per month (0.0169 to 0.0577, 90% prediction for a new study) Learned This study only 0.0312 per month (0.0216 to 0.045, 90% within-study bootstrap) LearnedGlobal default 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed | CorrectReject |
| Observed difference in change in HbA1c from baseline to week 52 change Chênh lệch thay đổi thay đổi HbA1c từ ban đầu đến tuần 52 quan sát được 241 patients, 3 sites | −0.36 % HbA1c (−0.63 to −0.0852, 90% within-study bootstrap) Learned This study only −0.36 % HbA1c (−0.63 to −0.0852, 90% within-study bootstrap) Learned | CorrectReject |
| SD of change in HbA1c from baseline to week 52 change Độ lệch chuẩn thay đổi thay đổi HbA1c từ ban đầu đến tuần 52 241 patients, 3 sites | 1.26 % HbA1c (1.06 to 1.51, 90% prediction for a new study) Learned This study only 1.26 % HbA1c (1.18 to 1.35, 90% within-study bootstrap) LearnedGlobal default 1.00 % HbA1c (0.80 to 1.30, 90% assumed range, no source yet) Assumed | CorrectReject |
| Days to close a data query, all sites Số ngày đóng truy vấn dữ liệu, tất cả cơ sở 207 patients, 3 sites | 8 days (5 to 13, 90% prediction for a new study) Learned This study only 8 days (8 to 9, 90% within-study bootstrap) Learned | CorrectReject |
| Days to close a data query, central hospitals Số ngày đóng truy vấn dữ liệu, bệnh viện trung ương 171 patients, 2 sites internal only | 7 days (5 to 11, 90% prediction for a new study) Learned This study only 7 days (7 to 7, 90% within-study bootstrap) Learned | CorrectReject |
| Days to close a data query, provincial hospitals Số ngày đóng truy vấn dữ liệu, bệnh viện tỉnh 36 patients, 1 sites internal only | 15 days (9 to 23, 90% prediction for a new study) Learned This study only 15 days (13 to 17, 90% within-study bootstrap) Learned | CorrectReject |
| Screened out by criterion C1 Bị loại theo tiêu chí C1 464 patients, 3 sites | 15.7% (9.2% to 25.5%, 90% prediction for a new study) Learned This study only 15.7% (13.3% to 18.5%, 90% within-study bootstrap) Learned | CorrectReject |
| Screened out by criterion C2 Bị loại theo tiêu chí C2 464 patients, 3 sites | 8.2% (4.5% to 14.5%, 90% prediction for a new study) Learned This study only 8.2% (6.3% to 10.6%, 90% within-study bootstrap) Learned | CorrectReject |
| Screened out by criterion C3 Bị loại theo tiêu chí C3 464 patients, 3 sites | 8.0% (4.4% to 14.0%, 90% prediction for a new study) Learned This study only 8.0% (6.2% to 10.1%, 90% within-study bootstrap) Learned | CorrectReject |
| Screened out by criterion C4 Bị loại theo tiêu chí C4 464 patients, 3 sites | 3.4% (1.7% to 6.8%, 90% prediction for a new study) Learned This study only 3.4% (2.3% to 5.2%, 90% within-study bootstrap) Learned | CorrectReject |
| Screen-failure rate Tỷ lệ sàng lọc thất bại 464 patients, 3 sites | 35.3% (23.1% to 49.8%, 90% prediction for a new study) Learned This study only 35.3% (31.9% to 38.9%, 90% within-study bootstrap) LearnedGlobal default 36.3% (25.0% to 50.0%, 90% published or brief range) Assumed | CorrectReject |
| Screened per site per month, all sites Số người sàng lọc mỗi cơ sở mỗi tháng, tất cả cơ sở 464 patients, 3 sites | 7.27 screened per site per month (4.41 to 12.0, 90% prediction for a new study) Learned This study only 7.27 screened per site per month (6.73 to 7.86, 90% within-study bootstrap) LearnedGlobal default 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed | CorrectReject |
| Screened per site per month, central hospitals Số người sàng lọc mỗi cơ sở mỗi tháng, bệnh viện trung ương 366 patients, 2 sites internal only | 8.23 screened per site per month (4.99 to 13.6, 90% prediction for a new study) Learned This study only 8.23 screened per site per month (7.55 to 8.98, 90% within-study bootstrap) LearnedGlobal default 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed | CorrectReject |
| Screened per site per month, provincial hospitals Số người sàng lọc mỗi cơ sở mỗi tháng, bệnh viện tỉnh 98 patients, 1 sites internal only | 5.06 screened per site per month (2.99 to 8.56, 90% prediction for a new study) Learned This study only 5.06 screened per site per month (4.23 to 6.06, 90% within-study bootstrap) LearnedGlobal default 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed | CorrectReject |
| Patients also using traditional medicine Bệnh nhân dùng thêm y học cổ truyền 3 clinicians | 31.0% (20.0% to 45.0%, 90% elicited range) Elicited | CorrectReject |
| Interim visits attended, all sites Tỷ lệ tham gia thăm khám giữa kỳ, tất cả cơ sở 293 patients, 3 sites | 87.5% (79.4% to 92.7%, 90% prediction for a new study) Learned This study only 87.5% (85.7% to 89.1%, 90% within-study bootstrap) LearnedGlobal default 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed | CorrectReject |
| Interim visits attended, central hospitals Tỷ lệ tham gia thăm khám giữa kỳ, bệnh viện trung ương 226 patients, 2 sites internal only | 89.2% (81.9% to 93.8%, 90% prediction for a new study) Learned This study only 89.2% (87.4% to 90.8%, 90% within-study bootstrap) LearnedGlobal default 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed | CorrectReject |
| Interim visits attended, provincial hospitals Tỷ lệ tham gia thăm khám giữa kỳ, bệnh viện tỉnh 67 patients, 1 sites internal only | 81.3% (69.4% to 89.3%, 90% prediction for a new study) Learned This study only 81.3% (76.2% to 85.5%, 90% within-study bootstrap) LearnedGlobal default 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed | CorrectReject |
Decided
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