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- Heggebo, L. C., et al.
(author)
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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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In: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
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Journal article (peer-reviewed)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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| 3. |
- Bringedal, B. H., et al.
(author)
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Guidelines and clinical priority setting during the COVID-19 pandemic - Norwegian doctors' experiences
- 2022
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In: Bmc Health Services Research. - : Springer Science and Business Media LLC. - 1472-6963. ; 22:1
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Journal article (peer-reviewed)abstract
- Background In the first phase of the COVID-19 pandemic, strong measures were taken to avoid anticipated pressure on health care, and this involved new priorities between patient groups and changing working conditions for clinical personnel. We studied how doctors experienced this situation. Our focus was their knowledge about and adherence to general and COVID-19 specific guidelines and regulations on priority setting, and whether actual priorities were considered acceptable. Methods In December 2020, 2 316 members of a representative panel of doctors practicing in Norway received a questionnaire. The questions were designed to consider a set of hypotheses about priority setting and guidelines. The focus was on the period between March and December 2020. Responses were analyzed with descriptive statistics and regression analyses. Results In total, 1 617 (70%) responded. A majority were familiar with the priority criteria, though not the legislation on priority setting. A majority had not used guidelines for priority setting in the first period of the pandemic. 60.5% reported that some of their patients were deprioritized for treatment. Of these, 47.5% considered it medically indefensible to some/a large extent. Although general practitioners (GPs) and hospital doctors experienced deprioritizations equally often, more GPs considered it medically indefensible. More doctors in managerial positions were familiar with the guidelines. Conclusions Most doctors did not use priority guidelines in this period. They experienced, however, that some of their patients were deprioritized, which was considered medically indefensible by many. This might be explained by a negative reaction to the externally imposed requirements for rationing, while observing that vulnerable patients were deprioritized. Another interpretation is that they judged the rationing to have gone too far, or that they found it hard to accept rationing of care in general. Priority guidelines can be useful measures for securing fair and reasonable priorities. However, if the priority setting in clinical practice is to proceed in accordance with priority-setting principles and guidelines, the guidelines must be translated into a clinically relevant context and doctors' familiarity with them must improve.
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- Hjorth-Hansen, A. K., et al.
(author)
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Real-time automatic quantification of left ventricular function by hand-held ultrasound devices in patients with suspected heart failure : a feasibility study of a diagnostic test with data from general practitioners, nurses and cardiologists
- 2022
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In: BMJ Open. - : BMJ. - 2044-6055. ; 12:10
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To evaluate the feasibility and reliability of hand-held ultrasound (HUD) examinations with real-time automatic decision-making software for ejection fraction (autoEF) and mitral annular plane systolic excursion (autoMAPSE) by novices (general practitioners), intermediate users (registered cardiac nurses) and expert users (cardiologists), respectively, compared to reference echocardiography by cardiologists in an outpatient cohort with suspected heart failure (HF). DESIGN: Feasibility study of a diagnostic test. SETTING AND PARTICIPANTS: 166 patients with suspected HF underwent HUD examinations with autoEF and autoMAPSE measurements by five novices, three intermediate-skilled users and five experts. HUD results were compared with a reference echocardiography by experts. A blinded cardiologist scored all HUD recordings with automatic measurements as (1) discard, (2) accept, but adjust the measurement or (3) accept the measurement as it is. PRIMARY OUTCOME MEASURE: The feasibility of automatic decision-making software for quantification of left ventricular function. RESULTS: The users were able to run autoEF and autoMAPSE in most patients. The feasibility for obtaining accepted images (score of ≥2) with automatic measurements ranged from 50% to 91%. The feasibility was lowest for novices and highest for experts for both autoEF and autoMAPSE (p≤0.001). Large coefficients of variation and wide coefficients of repeatability indicate moderate agreement. The corresponding intraclass correlations (ICC) were moderate to good (ICC 0.51-0.85) for intra-rater and poor (ICC 0.35-0.51) for inter-rater analyses. The findings of modest to poor agreement and reliability were not explained by the experience of the users alone. CONCLUSION: Novices, intermediate and expert users were able to record four-chamber views for automatic assessment of autoEF and autoMAPSE using HUD devices. The modest feasibility, agreement and reliability suggest this should not be implemented into clinical practice without further refinement and clinical evaluation. TRIAL REGISTRATION NUMBER: NCT03547076.
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