Table 1 How PRECISION addresses research needs for DCIS management (adapted from Gierisch et al.90)
From: Ductal carcinoma in situ: to treat or not to treat, that is the question
Rank | Prioritization of research need according to Gierisch et al.90 | Recommended study design by Gierisch et al.90 | Addressed in PRECISION |
|---|---|---|---|
1 | Validate risk-stratification models | Meta-analysis or individual patient data analysis across RCTs or observational study using existing data sources | Combining retrospective case-control studies based on nationwide, population-based cohorts |
2 | Compare safety and effectiveness of a management strategy involving no immediate treatment (i.e. monitoring/observation/active surveillance) versus immediate treatment with surgery, RT, and/or medical therapy | Prospective observational study | Prospective RCT to test safety of active surveillance for low-grade DCIS |
3 | Determine whether safety and effectiveness of DCIS management strategies differ depending on variations in clinical, pathologic, and genomic presentations of DCIS | Meta-analysis or individual patient data analysis across RCTs or observational study using existing data sources | Combining results from retrospective case-control studies and prospective RCTs |
4 | Comparative effectiveness of different approaches to communicating the diagnosis of DCIS to the patient | RCT | Evaluation level of being informed, QoL, and HTA in prospective RCTs |
5 | Comparative effectiveness of decision-making tools compared with usual care | RCT | Evaluation of prognostic factors, QoL, and HTA in prospective RCTs |
6 | Comparative sensitivity and specificity of breast MRI, mammography, and other preoperative imaging evaluations for detecting occult invasive breast cancer | Observational study either collecting new data or using existing data sources | Analysis based on mammograms collected in prospective RCTs |
7 | Assess effect of DCIS management strategies on comorbid conditions | RCT | Prospective RCTs |
8 | Compare safety and effectiveness of partial-breast RT versus whole-breast RT | RCT | Not addressed in this research proposed |
9 | Identify most important patient-centered outcomes for women diagnosed with DCIS | Observational study requiring new data collection | Prospective RCT for patient-centred outcomes |
10 | Assess effect of DCIS management strategies on rates of invasive cancer | Observational data using existing data | Retrospective case-control studies and prospective RCTs |
