Browsing by Subject "randomised controlled trial"

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  • Whelan, J. S.; Bielack, S. S.; Marina, N.; Smeland, S.; Jovic, G.; Hook, J. M.; Krailo, M.; Anninga, J.; Butterfass-Bahloul, T.; Bohling, T.; Calaminus, G.; Capra, M.; Deffenbaugh, C.; Dhooge, C.; Eriksson, M.; Flanagan, A. M.; Gelderblom, H.; Goorin, A.; Gorlick, R.; Gosheger, G.; Grimer, R. J.; Hall, K. S.; Helmke, K.; Hogendoorn, P. C. W.; Jundt, G.; Kager, L.; Kuehne, T.; Lau, C. C.; Letson, G. D.; Meyer, J.; Meyers, P. A.; Morris, C.; Mottl, H.; Nadel, H.; Nagarajan, R.; Randall, R. L.; Schomberg, P.; Schwarz, R.; Teot, L. A.; Sydes, M. R.; Bernstein, M.; EURAMOS Collaborators (2015)
  • HOT-ICU Investigators; Schjorring, Olav L.; Perner, Anders; Wetterslev, Jorn; Lange, Theis; Keus, Frederik; Laake, Jon H.; Okkonen, Marjatta; Siegemund, Martin; Morgan, Matthew; Thormar, Katrin M.; Rasmussen, Bodil S. (2019)
    Background Acutely ill adults with hypoxaemic respiratory failure are at risk of life-threatening hypoxia, and thus oxygen is often administered liberally. Excessive oxygen use may, however, increase the number of serious adverse events, including death. Establishing the optimal oxygenation level is important as existing evidence is of low quality. We hypothesise that targeting an arterial partial pressure of oxygen (PaO2) of 8 kPa is superior to targeting a PaO2 of 12 kPa in adult intensive care unit (ICU) patients with acute hypoxaemic respiratory failure. Methods The Handling Oxygenation Targets in the ICU (HOT-ICU) trial is an outcome assessment blinded, multicentre, randomised, parallel-group trial targeting PaO2 in acutely ill adults with hypoxaemic respiratory failure within 12 hours after ICU admission. Patients are randomised 1:1 to one of the two PaO2 targets throughout ICU stay until a maximum of 90 days. The primary outcome is 90-day mortality. Secondary outcomes are serious adverse events in the ICU, days alive without organ support and days alive out of hospital in the 90-day period; mortality, health-related quality-of-life at 1-year follow-up as well as 1-year cognitive and pulmonary function in a subgroup; and an overall health economic analysis. To detect or reject a 20% relative risk reduction, we aim to include 2928 patients. An interim analysis is planned after 90-day follow-up of 1464 patients. Conclusion The HOT-ICU trial will test the hypothesis that a lower oxygenation target reduces 90-day mortality compared with a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.
  • Veerus, Piret; Hovi, Sirpa-Liisa; Sevon, Tiina; Hunter, Myra; Hemminki, Elina (2012)
    BACKGROUND: For postmenopausal women, the main reason to start hormone therapy (HT) is to reduce menopausal symptoms and to improve quality of life (QOL). The aim of this study was to analyse the impact of HT on different aspects of symptom experience and QOL during a randomised trial.A total of 1823 postmenopausal women were recruited into the Estonian Postmenopausal Hormone Therapy (EPHT) trial in 1999-2001. Women were randomised to blind HT, open-label HT, placebo or non-treatment arm. After one year in the trial, a questionnaire was mailed and 1359 women (75%) responded, 686 in the HT arms and 673 in the non-HT arms. Mean age at filling in the questionnaire was 59.8 years. The questionnaire included Women's Health Questionnaire (WHQ) to assess menopause specific QOL of middle-aged women together with a 17-item questionnaire on symptoms related to menopause, a question about painful intercourse, and a question about women's self-rated health. RESULTS: After one year in the trial, fewer women in the HT arms reported hot flashes, trouble sleeping, and sweating on the symptom questionnaire. According to WHQ, women in the HT arms had fewer vasomotor symptoms, sleep problems, and problems with sexual behaviour, but more menstrual symptoms; HT had no effect on depression, somatic symptoms, memory, attractiveness, or anxiety. A smaller proportion of women reported painful intercourse in the HT arms. There were no significant differences between the trial arms in women's self-rated subjective health. CONCLUSIONS: The results from the EPHT trial confirm that HT is not justified for treating symptoms, other than vasomotor symptoms, among postmenopausal women. WHQ proved to be a useful and sensitive tool to assess QOL in this age group of women.