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- Christiansen, J. S., et al.
(författare)
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Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations
- 2016
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Ingår i: European Journal of Endocrinology. - : Oxford University Press (OUP). - 0804-4643 .- 1479-683X. ; 174:6
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). Participants: A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Evidence: Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Consensus process: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. Conclusions: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
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| 2. |
- Allen, K. D., et al.
(författare)
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Osteoarthritis: Models for appropriate care across the disease continuum
- 2016
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Ingår i: Best Practice and Research: Clinical Rheumatology. - : Elsevier BV. - 1521-6942. ; 30:3, s. 503-535
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Tidskriftsartikel (refereegranskat)abstract
- Osteoarthritis (OA) is a leading cause of pain and disability worldwide. Despite the existence of evidence-based treatments and guidelines, substantial gaps remain in the quality of OA management. There is underutilization of behavioral and rehabilitative strategies to prevent and treat OA as well as a lack of processes to tailor treatment selection according to patient characteristics and preferences. There are emerging efforts in multiple countries to implement models of OA care, particularly focused on improving nonsurgical management. Although these programs vary in content and setting, key lessons learned include the importance of support from all stakeholders, consistent program delivery and tools, a coherent team to run the program, and a defined plan for outcome assessment. Efforts are still needed to develop, deliver, and evaluate models of care across the spectrum of OA, from prevention through end-stage disease, in order to improve care for this highly prevalent global condition. © 2016
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