OBJECTIVE To develop and validate a self‐administered questionnaire to assess the ‘severity’ and ‘bothersomeness’ of the most frequently reported signs and symptoms of uncomplicated urinary tract infection (uUTI). SUBJECTS AND METHODS The UTI Symptoms Assessment questionnaire (UTISA) is a 14‐item instrument asking about the severity and bothersomeness of seven key uUTI symptoms. It was developed after comprehensive literature and data review and administration in draft form to a sample of 30 women with uUTI. The final questionnaire was completed by 276 women with uUTI who participated in a noncomparative clinical trial of ciprofloxacin. The women completed the questionnaire in electronic format at baseline (before the first dose of ciprofloxacin once‐daily), at 3‐h and 8‐h intervals until all UTI symptoms were resolved, and at the test‐of‐cure visit. Baseline scores on the King's Health Questionnaire (KHQ) were used to assess convergent and divergent validity; responses to the Global Rating of Change (GRC) were used to assess both responsiveness and the ‘minimally important difference’. Discriminant validity and responsiveness were assessed by comparing UTISA scores with a clinical evaluation of UTI symptoms performed by the investigator at baseline and at the test‐of‐cure visit. RESULTS The UTISA was found to comprise three four‐item domains named ‘urination regularity’, ‘problems with urination’, and ‘pain associated with UTI’. Two questions asking about haematuria loaded on a fourth factor. The three domains were homogeneous (with high inter‐item correlations) and internally consistent. Convergent validity was shown by high correlations between similar UTISA and KHQ domains (all rs > 0.40), and divergent validity by small correlations between unlike domains (all rs < 0.15). In general, the UTISA domains showed excellent discriminant validity, with scores on selected domains discriminating between women with different clinical evaluations. The responsiveness of the UTISA was also excellent, with high correlations between changes in domain scores and the clinical evaluation and GRC items. Symptom improvement was highest in the first 3 h, leading to greater responsiveness and minimally important difference during this period. However, the UTISA could detect even small subsequent changes. CONCLUSION The three‐domain UTISA has excellent psychometric properties and it is likely to prove an excellent tool for assessing uUTI outcome from a patient's perspective, both in research and clinical settings.

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To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.

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The economic evaluation indicates that sorafenib is cost-effective compared to best supportive care, with a cost-effectiveness ratio within the established threshold that US society is willing to pay (i.e. $US50,000-$US100,000) and significantly lower than alternative thresholds suggested in recent years ($US183,000-$US264,000/life-year gained, or $US300,000/quality-adjusted life-year) in oncology.