A 'gap' between physician and patient assessment of symptom severity in acute cystitis?: a multicenter trial of women treated with extended-release ciprofloxacin.
The current trial assessed differences in physician and patient symptom-severity perceptions in ambulatory outpatient females with uncomplicated urinary tract infections (uUTIs). We also investigated the efficacy and safety profile of once-daily ciprofloxacin in a 500-mg PO extended-release formulation for 3 days to treat acute cystitis. This prospective, open-label, multicenter (1,972 sites), phase 4 clinical trial enrolled 7,614 adult women with a clinical diagnosis of an acute uUTI. After assessing the patient's cystitis symptoms, physicians rated each cystitis-related symptom on a 4-point severity scale. Patients independently completed a pretreatment survey including a self-assessment of these same symptoms. Clinical outcomes were assessed at the end-of-study visit (2 to 7 days post-therapy). Exact agreement on symptom severity between physician and patient was between 54% and 57% for symptoms. The discrepancies between assessments were significant in the marginal homogeneity tests (P less than 0.00001). Clinical cure following this regimen was 91.3% of efficacy-valid women. Women who had 2 or more UTI episodes in the previous 12 months tended to have lower rates of clinical cure than those who had 1 or no episodes in that time.
Tucker
Mary Kay
MK
Wilkes Surgical Associates, Wilkesboro, North Carolina, USA.
Brigio
Frank D
FD
Sirotenko
G Alexis
GA
Keating
Karen N
KN
Perfetto
Eleanor M
EM
Wilson
Karen
K
Song
James
J
Colgan
Richard
R
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002648:Child; D002939:Ciprofloxacin / Q000008:administration & dosage*; D003556:Cystitis / Q000175:diagnosis* / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008875:Middle Aged; D010361:Patients; D011446:Prospective Studies; D012647:Self-Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D003692:Delayed-Action Preparations; D002939:Ciprofloxacin