The validation of patient-rated global assessments of treatment benefit, satisfaction, and willingness to continue--the BSW.
OBJECTIVE
This study evaluated the validity of three single-item, patient-rated, interviewer-administered, global assessments of treatment benefit, satisfaction with treatment and willingness to continue treatment, collectively referred to as the BSW.


METHODS
The BSW, micturition diaries, the Overactive Bladder Questionnaire (OAB-q) and the King's Health Questionnaire (KHQ) were included in part or in total in three OAB clinical trials. Discriminant validity for full and dichotomized responses was assessed with anovas models and correlations were used to evaluate construct validity.


RESULTS
The BSW demonstrated significant differences among the majority of the response levels on all measures of micturitions in all studies. The BSW also demonstrated discriminant validity with the OAB-q and the KHQ. BSW measures demonstrated significant differences among the change scores for all subscales of the OAB-q and the majority of the KHQ domains with both full and dichotomized responses. Patients who were dissatisfied with treatment and those unwilling to continue treatment also reported significantly worse OAB-q and KHQ scores compared with those who were satisfied with treatment or willing to continue treatment. BSW measures were moderately correlated with the micturition variables, moderate to strongly correlated with the OAB-q and weak to moderately with the KHQ, providing support for the construct validity of the BSW measures.


CONCLUSIONS
The BSW is a useful tool to capture patients' global impressions of three key elements of treatment outcome: a perceived benefit, satisfaction with treatment, and the willingness to continue treatment, and can facilitate patient-physician communication as well as be informative to researchers.
Pleil
Andreas M
AM
Pfizer Inc, San Diego, CA, USA.
Coyne
Karen S
KS
Reese
Pat Ray
PR
Jumadilova
Zhanna
Z
Rovner
Eric S
ES
Kelleher
Con J
CJ
D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use; D003408:Cresols / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology*; D017060:Patient Satisfaction; D010665:Phenylpropanolamine / Q000627:therapeutic use; D010919:Placebos; D011788:Quality of Life; D011795:Surveys and Questionnaires; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000188:drug therapy
D001559:Benzhydryl Compounds; D003408:Cresols; D010919:Placebos; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate