[Sensitivity to change and minimally important difference of the Spanish version of the life-satisfaction questionnaire LISAT-8 in male patients with erectile dysfunction].
OBJECTIVE
We determined the sensitivity to change and minimally important difference (MID) of the Spanish version of the life-satisfaction check list LISAT-8.


METHODS
We included a random sample obtained from an open, naturalistic, prospective and multicenter study, which assessed the effectiveness of sildenafil as erectile dysfunction (ED) therapy. A total of 537 patients, males older than 18 years, with ED and > active sexual desire, received flexible and at demand doses of sildenafil for 10 weeks. IIEF and LISAT-8 questionnaires were used. MID was determined from the patient's classification according to change in erectile function domain of the IIEF after treatment as follows: no change (< 5 pts), small change (6 to 10 pts), moderate change (11 to 15 pts) and big change (> 15 pts).


RESULTS
Sildenafil significantly modified the baseline punctuation of the LISAT 8 from a crude value of 30.2 (5.9) pts (mean [standard deviation]), at baseline, to 34.7 (5.6) pts after treatment., and from 55.4% (14.7%) to 66.8% (14.3%) in standardized punctuation (p < 0.0001 in both cases). Sildenafil responders showed a response increase of the total punctuation which was significantly higher than non-responders: 12.5% versus 4.3% (p < 0.001). MID was 3.2 pts as crude punctuation, and 8.1% in normalized score. Statistically significant correlations were found between changes in LISAT-8 and changes in IIEF.


CONCLUSIONS
The Spanish version of the LISAT-8 showed to be responsive to change in male ED patients. Meaningful MID was 3.1 pts (crude) and 8.1% (normalized).
Rejas
Javier
J
Departamento de Farmacoepidemiología y Farmacovigilancia, Unidad Médica, Pfizer S.A., Madrid, Spain. javier.rejas@pfizer.com
Gil
Angel
A
San Isidro
Carmen
C
Palacios
Gemma
G
Carrasco
Pilar
P
D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007802:Language; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use; D010879:Piperazines / Q000627:therapeutic use; D011687:Purines; D011788:Quality of Life; D000068677:Sildenafil Citrate; D013030:Spain; D013450:Sulfones; D011795:Surveys and Questionnaires
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate