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- Semb, G, et al.
(författare)
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Erratum
- 2017
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Ingår i: Journal of plastic surgery and hand surgery. - 2000-6764. ; 51:2, s. 158-158
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Tidskriftsartikel (refereegranskat)
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| 4. |
- Filippatos, G. S., et al.
(författare)
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Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases
- 2017
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 19:4, s. 449-456
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Tidskriftsartikel (refereegranskat)abstract
- Data Monitoring Committees (DMCs) play a crucial role in the conducting of clinical trials to ensure the safety of study participants and to maintain a trial's scientific integrity. Generally accepted standards exist for DMC composition and operational conduct. However, some relevant issues are not specifically addressed in current guidance documents, resulting in uncertainties regarding optimal approaches for communication between the DMC, steering committee, and sponsors, release of information, and liability protection for DMC members. The Heart Failure Association (HFA) of the European Society of Cardiology (ESC), in collaboration with the Clinical Trials Unit of the European Heart Agency (EHA) of the ESC convened a meeting of international experts in DMCs for cardiovascular and cardiometabolic clinical trials to identify specific issues and develop steps to resolve challenges faced by DMCs.The main recommendations from the meeting relate to methodological consistency, independence, managing conflicts of interest, liability protection, and training of future DMC members. This paper summarizes the key outcomes from this expert meeting, and describes the core set of activities that might be further developed and ultimately implemented by the ESC, HFA, and other interested ESC constituent bodies. The HFA will continue to work with stakeholders in cardiovascular and cardiometabolic clinical research to promote these goals.
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- Lohmander, A, et al.
(författare)
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Long-term, longitudinal follow-up of individuals with unilateral cleft lip and palate after the Gothenburg primary early veloplasty and delayed hard palate closure protocol: speech outcome
- 2012
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Ingår i: The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association. - : SAGE Publications. - 1545-1569. ; 49:6, s. 657-671
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Tidskriftsartikel (refereegranskat)abstract
- To investigate long-term, longitudinal speech outcome in patients born with unilateral cleft lip and palate treated according to a two-stage primary palatal protocol with early veloplasty and delayed hard palate closure. Design Retrospective, longitudinal cohort study. Setting A university hospital in western Sweden. Subjects A consecutive series of 55 patients from the total cohort of 65 were included. All patients had surgical procedures at Sahlgrenska University Hospital, Gothenburg, Sweden. Methods Standardized audio recordings were blindly analyzed at 5, 7, 16, and 19 years of age and after at a clinical visit at 10 years of age. Typical cleft speech variables were rated independently on ordinal scales. Intelligibility and perceived velopharyngeal function were assessed also. Prevalences of speech characteristics were determined, and interrater and intrarater agreement were calculated. Results Prominent hypernasality, nasal air leakage, and retracted oral articulation at 5 years were markedly reduced throughout the years with low prevalences at ages 16 and 19 years. Perceived velopharyngeal competence was noted in 82% at age 16 and 87% at age 19 years along with normal intelligibility. Pharyngeal flap surgery was performed in 6 of the 55 patients (11%). Conclusions Long-term speech outcome in patients with two-stage palatoplasty with early soft palate repair was considered good and improved even before hard palate repair. The typical retracted oral articulation was quite frequent during the early ages; whereas, nonoral misarticulations were almost nonexistent, implying good velopharyngeal competence.
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