We also aimed to explore the relationship between CONSORT-PRO reporting score and other key variables which we thought may influence reporting, including whether there was a significant difference in the primary trial endpoint or the PRO endpoint, compliance rates and year of publication.
The sponsor must foresee possible inability to achieve the preplanned statistical design, leading to an underpowered sub-study, or even the main study (if QIBs are used for the endpoints and compliance is poor), which could also be due to low compliance and quality of the scans.
Final endpoints were compliance, loco-regional control, survival (after complete 5-year follow-up), and a concept of trial assessment using the treatment-dependent prognostic index TPI.
For some clearly defined endpoints, the compliance between prediction and observation was found to be unbiased and sufficiently reliable to base regulatory decisions for combination products on CA predictions, eventually applying an additional safety factor of up to 10.
Our 2 endpoints were the compliance according to the SSC recommendations and the mortality between both groups.
Secondary endpoints are better compliance with aftercare, better clinical outcome and quality of life, as well as cost-effectiveness and cost-utility.
Noninferiority trials are carried out when (1) a placebo-controlled trial is not ethically feasible and (2) the treatment under test is not expected to be better that the standard or reference intervention in terms of efficacy but is supposedly better regarding other secondary endpoints, safety, costs, compliance, or convenience.
Secondary endpoints will include medication compliance (blood serum level), medication adverse effects, days missed at work/school, and social functioning level.
Descriptive statistics were used to summarize all baseline characteristics, treatment administration, compliance, efficacy endpoints, and safety parameters.
A total of 35 of the 76 reviewed studies assessed clinical endpoints (45%) including compliance and persistence (24 studies), likelihood of receiving treatment (14 studies), and clinical outcomes (7 studies).
