Obviously, the different endpoints require the use of different regression techniques: linear regression (CRQ), Cox regression for recurrent events (exacerbations) and Cox or logistic regression for mortality.
Uncontrolled asthma was identified either from exacerbations or from markers of acute loss of asthma control; date of occurrence of an event (exacerbation and/or acute loss of asthma control) was defined as index date.
Poisson regression correcting for overdispersion and adjusting for treatment exposure and with terms for subgroup and treatment-by-subgroup interaction was used for number-of-event (exacerbations) analyses.
Six patients during the primary 24-week trial period and an additional three at 48 weeks withdrew from the trial because of adverse events, including exacerbation of ongoing RA, hypotension and bronchopneumonia, staphylococcal septicaemia, renal impairment and rash.
The second type is conditions that are identified by acute manifestation of a chronic disease and whose survival is low, such as congestive heart failure,[ 8] where only a few years of observed hospital events (acute exacerbation) and mortality data are needed to reliably estimate the number of people currently living with the condition (prevalent cases).
In case any adverse event or exacerbation is defined by the investigator, relevant documentation should be made in the case report form.
Hospital-treated exacerbations and community-treated exacerbations cause loss of utility that is translated in the model into loss of QALY per an event of exacerbation.
Proportion of patients that experience an event-based exacerbation, i.e. the occurrence of an exacerbation for which antibiotic or corticosteroid treatment is initiated.
Most hospital admissions were planned, but many were unplanned, indicating that they arose from a recent health event or exacerbation of a condition (Table 2).
At study visits (Table 1), spirometry was measured (Microlab), questionnaires were administered (Asthma Control Questionnaire [ 21], Asthma Quality of Life Questionnaire [ 22], Leicester Cough Questionnaire) [ 23] and blood was drawn for haematological and biochemical profiles, and data was collected on adverse events, asthma exacerbations and non-study medication use.
