Act 3 · Learn
Behaviour profile
Local behaviour by layer, each value labelled and reviewed.
Sample values. Synthetic study, not real patients.
Profile version 1. Reviewed by a named investigator: 0% of parameters. The interval for a new study adds the elicited between-study spread to the within-study interval; one study cannot measure that spread.
Patient
| Parameter | For a new study | This study only | Evidence | Global default | Review | Source |
|---|---|---|---|---|---|---|
| Tablets taken as prescribed Tỷ lệ uống thuốc đúng chỉ định | 81.9% (71.7% to 88.9%, 90% prediction for a new study) Learned | 81.9% (81.3% to 82.4%, 90% within-study bootstrap) Learned | 293 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/adherence_proportion |
| Monthly dropout rate, all sites Tỷ lệ bỏ cuộc hằng tháng, tất cả cơ sở | 0.0184 per month (0.0108 to 0.0315, 90% prediction for a new study) Learned | 0.0184 per month (0.015 to 0.0227, 90% within-study bootstrap) Learned | 300 patients, 3 sites | 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed cited | pending | export:exp-71acbbf231#parameters/dropout_hazard_per_month |
| Monthly dropout rate, central hospitals Tỷ lệ bỏ cuộc hằng tháng, bệnh viện trung ương | 0.015 per month (0.00845 to 0.0267, 90% prediction for a new study) Learned | 0.015 per month (0.0112 to 0.0202, 90% within-study bootstrap) Learned | 231 patients, 2 sites | 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed cited | pending internal only | export:exp-71acbbf231#parameters/dropout_hazard_per_month:central_hospital |
| Monthly dropout rate, provincial hospitals Tỷ lệ bỏ cuộc hằng tháng, bệnh viện tỉnh | 0.0312 per month (0.0169 to 0.0577, 90% prediction for a new study) Learned | 0.0312 per month (0.0216 to 0.045, 90% within-study bootstrap) Learned | 69 patients, 1 sites | 0.0177 per month (0.0088 to 0.0353, 90% published or brief range) Assumed cited | pending internal only | export:exp-71acbbf231#parameters/dropout_hazard_per_month:provincial_hospital |
| Interim visits attended, all sites Tỷ lệ tham gia thăm khám giữa kỳ, tất cả cơ sở | 87.5% (79.4% to 92.7%, 90% prediction for a new study) Learned | 87.5% (85.7% to 89.1%, 90% within-study bootstrap) Learned | 293 patients, 3 sites | 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed no source yet | pending | export:exp-71acbbf231#parameters/visit_attendance_probability |
| Interim visits attended, central hospitals Tỷ lệ tham gia thăm khám giữa kỳ, bệnh viện trung ương | 89.2% (81.9% to 93.8%, 90% prediction for a new study) Learned | 89.2% (87.4% to 90.8%, 90% within-study bootstrap) Learned | 226 patients, 2 sites | 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/visit_attendance_probability:central_hospital |
| Interim visits attended, provincial hospitals Tỷ lệ tham gia thăm khám giữa kỳ, bệnh viện tỉnh | 81.3% (69.4% to 89.3%, 90% prediction for a new study) Learned | 81.3% (76.2% to 85.5%, 90% within-study bootstrap) Learned | 67 patients, 1 sites | 92.0% (85.0% to 97.0%, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/visit_attendance_probability:provincial_hospital |
System
| Parameter | For a new study | This study only | Evidence | Global default | Review | Source |
|---|---|---|---|---|---|---|
| Days for approval and ethics Số ngày phê duyệt và xét duyệt đạo đức | 120 days (80 to 200, 90% elicited range) Elicited | n/a | 3 clinicians | 160 days (90 to 365, 90% published or brief range) Assumed cited | pending | documents/debrief_elicitation.json#gap_fills/approval_and_ethics_days, comment:ethics letters: 49 and 64 days, plus ministry approval |
Investigator and site
| Parameter | For a new study | This study only | Evidence | Global default | Review | Source |
|---|---|---|---|---|---|---|
| Days from visit to data entry, all sites Số ngày từ thăm khám đến nhập dữ liệu, tất cả cơ sở | 7 days (5 to 11, 90% prediction for a new study) Learned | 7 days (7 to 8, 90% within-study bootstrap) Learned | 300 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/data_entry_lag_days |
| Days from visit to data entry, central hospitals Số ngày từ thăm khám đến nhập dữ liệu, bệnh viện trung ương | 6 days (4 to 9, 90% prediction for a new study) Learned | 6 days (6 to 6, 90% within-study bootstrap) Learned | 231 patients, 2 sites | none | pending internal only | export:exp-71acbbf231#parameters/data_entry_lag_days:central_hospital |
| Days from visit to data entry, provincial hospitals Số ngày từ thăm khám đến nhập dữ liệu, bệnh viện tỉnh | 13 days (8 to 19, 90% prediction for a new study) Learned | 13 days (12 to 14, 90% within-study bootstrap) Learned | 69 patients, 1 sites | none | pending internal only | export:exp-71acbbf231#parameters/data_entry_lag_days:provincial_hospital |
| Protocol deviations per patient-month, all sites Sai lệch đề cương mỗi bệnh nhân-tháng, tất cả cơ sở | 0.0487 per patient-month (0.0292 to 0.0813, 90% prediction for a new study) Learned | 0.0487 per patient-month (0.0425 to 0.0558, 90% within-study bootstrap) Learned | 300 patients, 3 sites | 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed no source yet | pending | export:exp-71acbbf231#parameters/deviation_rate_per_patient_month |
| Protocol deviations per patient-month, central hospitals Sai lệch đề cương mỗi bệnh nhân-tháng, bệnh viện trung ương | 0.0395 per patient-month (0.0235 to 0.0664, 90% prediction for a new study) Learned | 0.0395 per patient-month (0.0337 to 0.0464, 90% within-study bootstrap) Learned | 231 patients, 2 sites | 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/deviation_rate_per_patient_month:central_hospital |
| Protocol deviations per patient-month, provincial hospitals Sai lệch đề cương mỗi bệnh nhân-tháng, bệnh viện tỉnh | 0.0832 per patient-month (0.0485 to 0.14, 90% prediction for a new study) Learned | 0.0832 per patient-month (0.0667 to 0.10, 90% within-study bootstrap) Learned | 69 patients, 1 sites | 0.05 per patient-month (0.02 to 0.12, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/deviation_rate_per_patient_month:provincial_hospital |
| Days to close a data query, all sites Số ngày đóng truy vấn dữ liệu, tất cả cơ sở | 8 days (5 to 13, 90% prediction for a new study) Learned | 8 days (8 to 9, 90% within-study bootstrap) Learned | 207 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/query_turnaround_days |
| Days to close a data query, central hospitals Số ngày đóng truy vấn dữ liệu, bệnh viện trung ương | 7 days (5 to 11, 90% prediction for a new study) Learned | 7 days (7 to 7, 90% within-study bootstrap) Learned | 171 patients, 2 sites | none | pending internal only | export:exp-71acbbf231#parameters/query_turnaround_days:central_hospital |
| Days to close a data query, provincial hospitals Số ngày đóng truy vấn dữ liệu, bệnh viện tỉnh | 15 days (9 to 23, 90% prediction for a new study) Learned | 15 days (13 to 17, 90% within-study bootstrap) Learned | 36 patients, 1 sites | none | pending internal only | export:exp-71acbbf231#parameters/query_turnaround_days:provincial_hospital |
| Screened out by criterion C1 Bị loại theo tiêu chí C1 | 15.7% (9.2% to 25.5%, 90% prediction for a new study) Learned | 15.7% (13.3% to 18.5%, 90% within-study bootstrap) Learned | 464 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/screen_failure_C1 |
| Screened out by criterion C2 Bị loại theo tiêu chí C2 | 8.2% (4.5% to 14.5%, 90% prediction for a new study) Learned | 8.2% (6.3% to 10.6%, 90% within-study bootstrap) Learned | 464 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/screen_failure_C2 |
| Screened out by criterion C3 Bị loại theo tiêu chí C3 | 8.0% (4.4% to 14.0%, 90% prediction for a new study) Learned | 8.0% (6.2% to 10.1%, 90% within-study bootstrap) Learned | 464 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/screen_failure_C3 |
| Screened out by criterion C4 Bị loại theo tiêu chí C4 | 3.4% (1.7% to 6.8%, 90% prediction for a new study) Learned | 3.4% (2.3% to 5.2%, 90% within-study bootstrap) Learned | 464 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/screen_failure_C4 |
| Screen-failure rate Tỷ lệ sàng lọc thất bại | 35.3% (23.1% to 49.8%, 90% prediction for a new study) Learned | 35.3% (31.9% to 38.9%, 90% within-study bootstrap) Learned | 464 patients, 3 sites | 36.3% (25.0% to 50.0%, 90% published or brief range) Assumed cited | pending | export:exp-71acbbf231#parameters/screen_failure_proportion |
| Screened per site per month, all sites Số người sàng lọc mỗi cơ sở mỗi tháng, tất cả cơ sở | 7.27 screened per site per month (4.41 to 12.0, 90% prediction for a new study) Learned | 7.27 screened per site per month (6.73 to 7.86, 90% within-study bootstrap) Learned | 464 patients, 3 sites | 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed no source yet | pending | export:exp-71acbbf231#parameters/screening_rate_per_site_per_month |
| Screened per site per month, central hospitals Số người sàng lọc mỗi cơ sở mỗi tháng, bệnh viện trung ương | 8.23 screened per site per month (4.99 to 13.6, 90% prediction for a new study) Learned | 8.23 screened per site per month (7.55 to 8.98, 90% within-study bootstrap) Learned | 366 patients, 2 sites | 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/screening_rate_per_site_per_month:central_hospital |
| Screened per site per month, provincial hospitals Số người sàng lọc mỗi cơ sở mỗi tháng, bệnh viện tỉnh | 5.06 screened per site per month (2.99 to 8.56, 90% prediction for a new study) Learned | 5.06 screened per site per month (4.23 to 6.06, 90% within-study bootstrap) Learned | 98 patients, 1 sites | 6.00 screened per site per month (2.00 to 12.0, 90% assumed range, no source yet) Assumed no source yet | pending internal only | export:exp-71acbbf231#parameters/screening_rate_per_site_per_month:provincial_hospital |
Design lessons
| Parameter | For a new study | This study only | Evidence | Global default | Review | Source |
|---|---|---|---|---|---|---|
| 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 | −0.36 % HbA1c (−0.63 to −0.0852, 90% within-study bootstrap) Learned | −0.36 % HbA1c (−0.63 to −0.0852, 90% within-study bootstrap) Learned | 241 patients, 3 sites | none | pending | export:exp-71acbbf231#parameters/observed_treatment_difference |
| 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 | 1.26 % HbA1c (1.06 to 1.51, 90% prediction for a new study) Learned | 1.26 % HbA1c (1.18 to 1.35, 90% within-study bootstrap) Learned | 241 patients, 3 sites | 1.00 % HbA1c (0.80 to 1.30, 90% assumed range, no source yet) Assumed no source yet | pending | export:exp-71acbbf231#parameters/outcome_change_sd |
Clinical practice
| Parameter | For a new study | This study only | Evidence | Global default | Review | Source |
|---|---|---|---|---|---|---|
| Patients also using traditional medicine Bệnh nhân dùng thêm y học cổ truyền | 31.0% (20.0% to 45.0%, 90% elicited range) Elicited | n/a | 3 clinicians | none | pending | documents/debrief_elicitation.json#gap_fills/traditional_medicine_use_proportion, comment:C-DB-06 |