In addition to baseline variables, process variables (weight, diary adherence and frequency of GP-visits) were recorded at 12 weeks.
The frequency of GP-visits, type 2 diabetes, and diary adherence had an indirect effect through an impact on 12 week EWL.
Of note, although patients were asked to maintain a medication diary, adherence to antihypertensive medication was not formally tested by directly observed therapy or by urine antihypertensive drug assay in this study.
Besides diagnosis of CM-MO, admission criteria included a follow-up of at least 12 months, reliable monthly records on headache diaries, adherence to the follow-up schedule, disability and psychological assessment (MIDAS, HIT-6, SDS) [3].
With regard to the placebo-controlled studies themselves, the participants were required to be highly adherent with medications, visits and daily diaries, with adherence with maintenance medication of 97 98% in one study [ 56]); published timeline data revealed that study inhalers were not started until symptoms and airflow limitation had worsened for an average of 4 5 days [ 56, 57].
Patient-reported outcomes (PROs) are self-report instruments that directly measure the patient's perceptions of the impact of disease and treatment as clinical trial endpoints, and include multi-item health-related quality of life (HRQOL) instruments, as well as single-item measures (e.g., pain visual analogue scale), daily diaries, treatment adherence, and healthcare satisfaction [ 1, 2].
Patient-reported outcomes (PROs) are self-report instruments that directly measure the patient's perceptions of the impact of disease and treatment as clinical trial endpoints, and include multi-item HRQOL instruments, as well as single-item measures (e.g., pain visual analogue scale), daily diaries, treatment adherence, and healthcare satisfaction [ 15, 16, 23].
Further work is needed to determine the optimal recording timeframe for diary recordings, as adherence rates may decrease over time, thus reducing the validity of estimates.
Additional qualitative data will be collected through the patient diary to assess adherence to the intervention.
This was practiced daily and progressed weekly using a diary to record adherence.
Participants randomized to the exercise groups completed a weekly diary to record adherence to the home exercise program.
