Overactive bladder (OAB) is a chronic condition with a prevalence of approximately 11% in men and 13% in women in Europe [1
]. Despite a significant armamentarium of effective agents available for the treatment of overactive bladder, many patients with OAB symptoms do not discuss their symptoms with their healthcare provider and remain untreated. In addition, once symptoms are identified and patients are treated, they often discontinue treatment when their expectations are not achieved [2
]. Successful management of OAB and lower urinary tract symptoms (LUTS) may be contingent on patients having realistic treatment goals and on clinicians understanding which treatment goals are most important, for example, those symptoms that have the greatest severity or debilitating impact on patients' lives.
The Self-Assessment Goal Achievement (SAGA) questionnaire is a communication tool designed to help patients with LUTS and their healthcare providers adopt reasonable treatment expectations and assess goal achievement [3
]. Developing realistic treatment expectations and attaining those goals may lead to improved treatment outcomes, a concept observed in other therapeutic areas [6
]. Briefly, the baseline SAGA module asks patients to rate the importance of 9 prespecified (fixed) treatment goals that describe reducing the following LUTS: frequency (daytime and nighttime); sensation of pressure; primary sensation to use the bathroom; bladder voiding; starting or maintaining a urine stream; urine loss when coughing, laughing, exercising, or sneezing; urine leakage; and urgency. In addition to the 9 fixed goals, patients can list up to 5 additional (open) treatment goals. Patients rate the importance of each goal using a 5-point scale ranging from "not very important goal" to "very important goal." In the SAGA follow-up module, patients rate their achievement of each individualized goal and overall goal achievement with a 5-point scale ranging from "did not achieve goal" to "greatly exceeded goal." SAGA is the first questionnaire to capture individualized treatment expectations and goals regarding LUTS [8
European regulatory bodies have raised concerns over the validity of measures developed in one language and then used in other languages [10
]. The European Regulatory Issues and Quality of Life Assessment (ERIQA) Group recommends that a rigorous approach is taken in the translation of patient-reported outcome (PRO) measures for use in international settings to achieve conceptual and semantic equivalence across languages [11
]. Guidance for gaining this evidence is provided in a publication generated by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), entitled Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report
] which was developed to expand on a previous publication (2005) that provided guidance for the translation of PRO measures [13
]. Because there exists an increased need to translate and culturally adapt PRO measures, the document details areas designed to maintain content integrity during translation. Similarly, the US Food and Drug Administration recommends that language translations of PRO instruments being used in countries where the language is not the same as the country in which the instrument was developed show evidence that the content validity and other measurement properties of the instrument remain equivalent to those of the original version [14
A harmonized translation of the SAGA questionnaire was created in 12 languages: Danish, Dutch, English (UK), Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Spanish, and Swedish. The objective of the present study was to conduct a linguistic validation of the SAGA questionnaire for those 12 European languages to document that each translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population.