To ensure a credible comparison with existing INX data, the disease definition for enrolment in our study was identical to ATTRACT 1 and a separate phase III trial of INX in RA, 12 and was similar to a further, more recent trial.
We held monthly meetings between physicians at all centres, including the coordinating centre (Hospital Universitario de Getafe), to address issues or problems with definitions or enrolment.
Strengths of the current analysis include the randomization of study subjects to LAIV versus TIV that provided two treatment groups with similar baseline characteristics, the prospective collection of history of asthma and wheezing at enrolment, and the prospective definitions of the wheezing endpoints.
The authors recognize that since completion of enrolment in this study the definition of sepsis and septic shock has changed [18].
Furthermore, clear operation definitions are required to describe what is being measured, for example, explicit definitions for referral rates, enrolment rates and attendance rates need to be agreed to ensure that the information collected is accurate and interpretable.
Comparison is limited, however, by differences in enrolment criteria (larger lesions in our study), definition and timing of study endpoints.
9 11 Patients meeting criteria for ARDS using the AECC definition 7 were considered for enrolment in the parent studies.
This definition of seronegative women included, at enrolment, 3110 women above and 5307 women below one standard deviation of study virgins; at follow-up, this definition included 1470 women above and 5495 women below one standard deviation of study virgins.
A critical review of trials specifically addressing brain metastases shows key issues that could prevent acceptance of results by regulatory agencies, including enrolment of heterogeneous groups of patients and varying definitions of clinical endpoints.
This chapter explores the key methodological elements of these registries in terms of patient enrolment, the source of exposure and outcome information, outcome definition and ascertainment and comparator groups and how these elements may influence the reported risk estimates.
