Primary goals of this implementation study were to determine the participation rate, feasibility and logistics of this type of screening.
Using the percentage of negative replies and the drop-out rate, feasibility criteria RES_1 and RES_2 can be calculated.
Completion rate (feasibility) was defined as the number of participants who completed study procedures that included testing (multiplex and confirmatory), pretest and post-test counselling, and declaration of results over the total number of participants that consented.
As primary endpoints, we defined: the oncological safety of oncoplastic breast surgery (clear margins, low recurrence rate) and feasibility (reexcision rates, secondary mastectomy rates) as well as patient satisfaction [patient-reported outcome (PRO)].
During Phase II of the study, the trial will assess safety (toxicity), activity (failure-free rate) and feasibility (recruitment rate and protocol dose modifications/delays) in 90 patients in the experimental arm.
The final disposition of each indicator was based on the median validity rating, median feasibility rating, and agreement among panellists expressed as a percentage.
For the rating of "feasibility" of items to address, the clusters with the highest rating values were Resources Needed for Effective Tracing, Poor Documentation, and Health Worker Issues Related to Tracing.
They were included in the final set without being submitted to a second round because they received an unusually high rating for feasibility and validity (≥75%).> -wrap-foot> Percentage of participants rating the indicator in the top tertile (7 9/9).
Although our study had a focus on developing indicators measuring patient benefits, the final list contains only a relatively small number of these since most of the indicators of health service impact and patient benefits found in the literature either had little or no methodology provided or received a low rating for feasibility or validity.
Third, although we have proven the applicability of our two-in-one strategy in a real world setting with a high uptake rate and a fair referral rate, its feasibility would be limited in areas where the resource for endoscopists is constrained or the expense for upper endoscopy is high.
