Aim: There is growing interest for patient-reported outcomes (PROs) in clinical research. Application of quality of life (QoL) questionnaires to patients suffering from chronic venous disease (CVD) is thought to be an important improvement in the assessment of results in these complex disorders. The aims of the study were to describe the health status of female patients suffering from CVD, and to assess the care impact through QoL questionnaires.
Methods: Symptomatic female patients suffering from CVD (all CEAP clinical classes), aged over 18, newly treated by their general practitioner with a phlebotropic drug were enrolled in the study. Every patient had to complete a self-questionnaire including the SF-12, the CES-D, the Epworth and the CIVIQ scales at day 0 (D0), day 3 (D3) and day 7 (D7). The CIVIQ scale assesses pain and the psychological, physical and social consequences of CVD. The SF-12 is a generic measure of health status. The CES-D scale studies presence of depressive symptoms (DS) in the general population. The Epworth scale measures daytime sleepiness.
Results: A total of 765 physicians took part in the survey from April to August 2003. The results of the study concern 1 045 patients. Analyses are realized on the 399 patients who filled out all 3 questionnaires. Mean age was 45 years (SD=11), patients average height was 164.39 cm (SD=5.99) for an average weight of 65.2 kg (SD=12.5). Concerning change in QoL between inclusion and Day 7, the mean CIVIQ total scores at inclusion were 26.7 in the CEAP class 0-2 group and 36.3 in the CEAP class 3-6 group. The mean CIVIQ total scores at D7 were 18.5 in the CEAP class 0-2 group and 27.3 in the CEAP class 3-6 group. The mean CIVIQ total scores demonstrated that QoL is more impaired for patients in the CEAP class 3-6 group. In both groups, an improvement in patients' QoL was observed following patient management (P<0.001). At inclusion time, MCS-12 and PCS-12 were respectively 44.7 (SD=10.6) and 46.4 (SD=8.4): at day 3 and day 7, these dimensions were respectively: D3: 46.5 (SD=10.2) and 46.2 (SD=8) D7: 48 (SD=10.3) and 46.2 (SD=7.8). For the mental dimension, the difference was statistically significant (P=0.0001). In our study a possible DS (score ?17) was reported for 36.3%, 32.3% and 29% respectively at day 0, D3 and D7 (P<0.01, n=328). Concerning daytime sleepiness the Epworth mean total score showed a decrease in daytime sleepiness for patients with severe CVD (C3-C6) between day 0 and D 7 (P=0.02).
Conclusions: Our study demonstrates the high impact of CVD on health status and the validity of QoL questionnaires in this pathology. They show a significant improvement of the QoL after one week of medical management.