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Objective: Breakthrough cancer pain (BTcP) affects 19-95% of cancer patients (dependent on the definition and methods used and the populations studied) and is associated with detrimental physical, psychological and social complications in affected individuals as well as with significant economic burden on society and the healthcare system. This study evaluated the analgesic efficacy and safety of intranasal fentanyl spray (INFS) for the treatment of BTcP in a clinical setting with a special focus on its impact on health care resource utilization. Research design and methods:This was a prospective, open-label, noninterventional, multi-center study. Opioid-tolerant adult patients with BTcP received INFS in the course of routine clinical practice, and completed standardized questionnaires as well as BTcP diaries over a 28-day observation period. Clinical trial registration: ClinicalTrials.gov Identifier: NCT00994760Main outcome measures: Efficacy was assessed using measures of BTcP intensities, the times to first and to the maximum effect of INFS, as well as changes in BTcP-related restrictions in quality-of-life (QoL), activities of daily life (ADL) and overall wellbeing. Further analyses based on INFS-related changes in health care resource utilization. Treatment emergent adverse events (TEAEs) were recorded throughout.Results: Overall, 58 centers participated and enrolled 131 patients, of whom 116 (88.5%) completed the observation period and documented a total of 556BTcP episodes. The 100µg dose was judged as the most effective INFS dose in 64.0a% of patients, followed by 50 µg (28.0a%) and 200 µg (8.0 a%). The study recorded a substantial INFSrelated improvement in maximum BTcP intensity, compared with baseline as well as prior use. Patients reported experiencing the first effects of the study drug within 5 minutes of administration in 81.9% of episodes, and a time to maximum effect within 10 minutes in 81.4% of episodes. QoL and BTcP-related restrictions in ADL showed considerable improvements during the observation period. INFS was well tolerated, with sixpatients (4.6%) experiencing ≥1 study drug-related adverse event. Study limitations include a modest size and duration, and the single-arm design. Conclusion:Under the conditions of this non-interventional open-label study, INFS proved to be a rapid onset, highly effective and well tolerated alternative for the treatment of BTcP in opioid-tolerant cancer patients. INFS treatment was not only associated with substantial improvements in BTcP intensity as well as related restrictions in QoL and ADL, but also with a respectable decrease of health care resource demands -especially in the field of ambulatory palliative care nursing services.relatively stable and adequately controlled background pain [2]. Due to epidemiological studies, BTcP is a common cancer complication with reported prevalence rates ranging between 19-95% (dependent on the definition and methods used, and the populations studied) [3][4][5][6][7], which is accompanied by detrimental rest...

A631there are still major gaps in the knowledge about UTI and many of the school-going adolescent girls though unaware, are at high risk of UTI. Ignorance of hygiene, symptoms and risk factors may front to unidentified cases of UTI and likely go on without medical intervention thus degenerating into serious urinary and genital tract complications. This calls for an urgent need for educational talks periodically addressing these gaps.

A595 groups were held with 61 individuals who were overweight (BMI: 27.0-29.9) or with obesity (WHO class 1-3) in the U.S. Focus groups were conducted separately by gender and overweight/obesity class status. Transcripts were analyzed utilizing Dedoose and adapted grounded theory qualitative research methods. Based on the analysis, criteria for inclusion of which signs and symptoms were major vs. minor and proximal vs. distal were generated. A "clinical challenge" was then held with 3 obesity specialists to assess if the key signs and symptoms were clinically important, reported by patients in their clinical practice, and likely to improve with 5-10% weight loss. Results: Sixty-one overweight/obese respondents reported 33 physical (range 2-74% reported) and 7 emotional signs and symptoms (range 8-72%). Ten major signs and symptoms were endorsed across all weight classes and genders and found to be clinically relevant and interpretable to overweight/obese individuals. The top 3 signs and symptoms were shortness of breath, joint pain, and back pain. Saturation of themes was achieved by the sixth focus group (95% of concepts). Based on these findings, a theoretical model of overweight/obesity signs and symptoms, impacts of the signs and symptoms, and modifiers to the impact severity was developed. ConClusions: Identification of the major patient-reported signs and symptoms of being overweight/obese can provide the basis for a patient-reported outcome measure with strong concept validity and allow both clinicians and researchers to assess treatment benefit.