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- Heggebo, L. C., et al.
(författare)
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Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden
- 2023
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase (IDH)-mutated diffuse gliomas grade 2-3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life.Methods and analysisPRO-GLIO (PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18-65 years with IDH-mutated diffuse gliomas grade 2-3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints.Ethics and disseminationTo implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums.Trial registration numberClinicalTrials.gov Registry (NCT05190172).
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- Eide, A. H., et al.
(författare)
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Barriers for Accessing Assistive Products in Low- and Middle-Income Countries (LMICs)
- 2023
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Ingår i: Studies in Health Technology and Informatics. - : NLM (Medline). - 0926-9630 .- 1879-8365. ; 306, s. 297-302
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Tidskriftsartikel (refereegranskat)abstract
- WHO implemented the Rapid Assistive Technology Assessment in 2021. This is a household survey on self-reported use, need and barriers for accessing AT in 35 countries globally. In order to obtain comparable data, all surveys followed guidelines developed by WHO, including national two-stage random sampling of households. The 2021 rATA survey included 32 of a total of 140 LMICs globally. Around 40 % of the total respondents (all countries) estimated travel distance to be <5 km, varying from less than 10 % to almost 60 % among the countries. Around 15 % had to travel more than 50 km, varying from 1.3 % to 37.5 %. More individuals living in rural as compared to urban areas had to travel more than 25 km to get their main assistive product. Gender differences were marginal. By far the most prevalent barrier to access assistive products was "Cannot afford", amounting to 39.9% and varying from 6.7 % to 79.1 % among countries. This was followed by "No support" with 14.3 %, varying from 2.3 % to 36.9 %, and "Not available" with 8.1 %, varying from 1 % to 21.5 %. More barriers were reported in rural than urban areas and women report more barriers than men. Variation between countries in both travel time and barriers is substantial and country-specific service development is needed to guide service development.
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