Development and validation of a condition-specific diary to measure severity, bothersomeness and impact on daily activities for patients with acute urinary tract infection in primary care.
BACKGROUND
Urinary tract infection (UTI) is a common condition in primary care. Patient-reported outcome measures (PROMs) are crucial in the evaluation of interventions to improve diagnosis, treatment and prognosis of UTI. The aim of this study was to identify an existing condition-specific PROM to measure symptom severity, bothersomeness and impact on daily activities for adult patients with suspected urinary tract infection in primary care; or, in the absence of such a PROM, to test items identified from existing PROMs for coverage and relevance in single and group interviews and to psychometrically validate the resulting PROM.


METHODS
The literature was searched for existing PROMs covering the three domains. Items from the identified PROMs were tested in single and group interviews. The resulting symptom diary was psychometrically validated using the partial credit Rasch model for polytomous items in a cohort of 451 women participating in two studies regarding UTI.


RESULTS
No existing PROM fulfilled the inclusion criteria. Content validation resulted in one domain concerning symptom severity (18 items), one concerning bothersomeness (18 items), and one concerning impact on daily activities (7 items). Psychometrical validation resulted in four dimensions in each of the first two domains and one dimension in the third domain.


CONCLUSIONS
Domains were not unidimensional, which meant that we identified dimensions of patient-experienced UTI that differed substantially from those previously found. We recommend that future studies on UTI, in which PROMs are to be used, should ensure high content validity of their outcome measures and unidimensionality of the included dimensions.
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO box 2099, 1014, Copenhagen, Denmark. anneholm@sund.ku.dk.
Anne
http://orcid.org/0000-0003-3819-3429
A
Holm
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO box 2099, 1014, Copenhagen, Denmark.
Gloria
G
Cordoba
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO box 2099, 1014, Copenhagen, Denmark.
Volkert
V
Siersma
Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO box 2099, 1014, Copenhagen, Denmark.
John
J
Brodersen
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D011320:Primary Health Care; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires / Q000592:standards*; D014552:Urinary Tract Infections / Q000523:psychology*
Cystitis; Item-response theory; PROM; Patient-reported outcome measures; Patient-reported outcomes; Primary care; Psychometrics; Rasch analysis; Urinary tract infections; Validation studies