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"Berge, Bjørn"
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Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?
In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor-biobank relationship meet high ethical standards. Up until now, a 'broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top-down governance. Recently, an approach termed 'dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.
Journal Article
Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial
Autologous grafting, despite some disadvantages, is still considered the gold standard for reconstruction of maxillofacial bone defects. The aim of this study was to evaluate bone regeneration using bone marrow-derived mesenchymal stromal cells (MSCs) in a clinical trial, a less invasive approach than autologous bone grafting. This comprehensive clinical trial included subjects with severe mandibular ridge resorption.
The study included 11 subjects aged 52-79 years with severe mandibular ridge resorption. Bone marrow cells were aspirated from the posterior iliac crest and plastic adherent cells were expanded in culture medium containing human platelet lysate. The MSCs and biphasic calcium phosphate granules as scaffolds were inserted subperiosteally onto the resorbed alveolar ridge. After 4-6 months of healing, new bone formation was assessed clinically and radiographically, as were safety and feasibility. Bone at the implant site was biopsied for micro-computed topography and histological analyses and dental implants were placed in the newly regenerated bone. Functional outcomes and patient satisfaction were assessed after 12 months.
The bone marrow cells, expanded in vitro and inserted into the defect together with biphasic calcium phosphate granules, induced significant new bone formation. The regenerated bone volume was adequate for dental implant installation. Healing was uneventful, without adverse events. The patients were satisfied with the esthetic and functional outcomes. No side effects were observed.
The results of this comprehensive clinical trial in human subjects confirm that MSCs can successfully induce significant formation of new bone, with no untoward sequelae. Hence, this novel augmentation procedure warrants further investigation and may form the basis of a valid treatment protocol, challenging the current gold standard.
EudraCT, 2012-003139-50. Registered on 21 August 2013. ClinicalTrials.gov, NCT 02751125 . Registered on 26 April 2016.
Journal Article
Elucidation of Phosphatidylcholine Composition in Krill Oil Extracted from Euphausia superba
High performance liquid chromatography-electrospray tandem mass spectrometry was used to elucidate the phospholipids in krill oil extracted from Euphausia superba, an emerging source for human nutritional supplements. The study was carried out in order to map the species of the choline-containing phospholipid classes: phosphatidylcholine and lyso-phosphatidylcholine. In addition, the prevalent phosphatidylcholine class was quantified and the results compared with prior analysis. The qualification was performed with separation on a reverse phase chromatography column, while the quantification was obtained with class separation on a normal phase chromatography column. An Orbitrap system was used for the detection, and pulsed-Q dissociation fragmentation was utilized for the identification of the species. An asymmetrical exclusion list was applied for detection of phospholipid species of lower concentration, significantly improving the number of species observed. A total of 69 choline-containing phospholipids were detected, whereof 60 phosphatidylcholine substances, among others seven with probable omega-3 fatty acids in both sn-1 and sn-2. The phosphatidylcholine concentration was estimated to be 34 ± 5 g/100 g oil (n = 5). These results confirm the complexity of the phospholipid composition of krill oil, and the presence of long chained, heavily unsaturated fatty acids.
Journal Article
Metabolism in the tumor microenvironment: implications for pathogenesis and therapeutics
The immune system protects the body against dangers that include pathogens, damage and cancer. Modern cancer therapies have sought to bolster immune responses against cancer using immunotherapy, which may include various forms of immune checkpoint therapy (ICT) in addition to methods of adoptive cell transfer (ACT), which is often associated with transfer of chimeric antigen receptor (CAR) T cells. Despite favorable outcomes in some patients and some cancers, as many as 60-80% of patients fail to benefit from ICT due to primary or adaptive resistance. This highlights the need for deeper understanding of how cancers suppress the immune system. Solid tumors, which make up approximately 90% of all cancers, are characterized by an immunosuppressive tumor microenvironment (TME). A hallmark of the TME is dysfunctional vascularization and impaired perfusion, which hinder effective drug delivery and promote hypoxia-induced metabolic reprograming in both cancer and immune cells. As the TME imposes intense metabolic stress through nutrient competition and lactate-driven acidification – both of which activates immunosuppressive pathways, targeting the TME itself may be beneficial in enhancing the efficacy of immunotherapy. Here we will briefly discuss the potential of targeting the metabolism of the TME as a means to promote normalized tumor vascularization and/or enhance anti-tumor immune responses.
Journal Article
Methods, challenges and benefits of a health monitoring programme for Norwegian Olympic and Paralympic athletes: the road from London 2012 to Tokyo 2020
ObjectiveTo describe the implementation of a health monitoring programme for Norwegian Paralympic and Olympic candidates over five consecutive Olympic and Paralympic Games cycles (London 2012, Sochi 2014, Rio de Janeiro 2016, PyeongChang 2018 and Tokyo 2020).MethodsAthletes were monitored for 12–18 months preparing for the games using a weekly online questionnaire (OSTRC-H2) with follow-up by physicians and physiotherapists, who provided clinical care and classified reported problems.ResultsBetween 2011 and 2020, 533 Olympic and 95 Paralympic athletes were included in the monitoring programme, with an overall response of 79% to the weekly questionnaire and a total observation period of 30 826 athlete weeks. During this time, 3770 health problems were reported, with a diagnosis rate of 97%. The average prevalence of health problems at any given time was 32% among Olympic athletes and 37% among Paralympic athletes. Acute traumatic injuries represented the greatest burden for Olympic team sport athletes, and illnesses represented the greatest burden for Olympic endurance and Paralympic athletes. On average, Olympic athletes lost 27 days and Paralympic athletes lost 33 days of training per year due to health problems.ConclusionConducting long-term health monitoring of Olympic and Paralympic athletes is challenging, particularly because athletes travel frequently and often relate to many medical providers. This programme has been implemented and improved within Team Norway for five Olympic and Paralympic cycles and during this time we believe it has helped protect our athletes’ health.
Journal Article
Light of both high and low melanopic illuminance improves alertness and attention during daytime
Light exposure during the day exerts acute effects on attention, such as how alert and ready a person is for solving problems and goal-oriented behavior. However, to increase the understanding of how different light conditions during daytime affect our attention, there is a need for more studies. The current study, using a sample of healthy, young adults (
N
= 39; 21.7 ± 2.6 y, 61.5% female), tested the acute effects of morning exposure (09:00–11:00) to four artificial lights on attention and alertness with the Psychomotor Vigilance Task (PVT). The PVT was administered three times in short-wavelength “blue” light [SWL, high melanopic illuminance], long-wavelength “red” light [LWL, low melanopic illuminance], and bright white light [BWL] of high correlated color temperature, and white dim light [DL] as control condition. PVT measures included fluctuations in attention, quantified as intra-individual Reaction Time (RT) variability and the number of lapses; mean RT; and optimum response capability (10% fastest RTs). Compared to DL, participants had significantly fewer lapses and faster mean RT during SWL and LWL, and they enhanced their optimum responses in LWL. There were no significant effects of BWL, and light did not affect RT variability. Surprisingly, SWL was not superior to LWL. Hence, our results suggest that light of both high and low melanopic illuminance can improve alertness and attention in the morning.
Journal Article
Injury and illness among Norwegian Olympic athletes during preparation for five consecutive Summer and Winter Games
ObjectiveTo describe the patterns of health problems among Norwegian Olympic candidates during their preparations for five consecutive Olympic Games (London 2012, Sochi 2014, Rio de Janeiro 2016, PyeongChang 2018 and Tokyo 2020).MethodsThis was a descriptive epidemiological study using the Oslo Sports Trauma Research Center Questionnaire on Health Problems to collect data on all self-reported health problems from Norwegian Olympic candidate athletes for 12–18 months prior to each Olympic Games. Team physicians and physiotherapists followed up the athlete reports, providing clinical care and classifying reported problems according to the International Olympic Committee 2020 consensus statement on methods for recording and reporting of epidemiological data on injury and illness in sport.ResultsBetween 2011 and 2020, 533 athletes were included in the Norwegian Olympic team monitoring programme, with a 78% response to the weekly questionnaire. During this time, athletes reported 2922 health problems, including 1409 illnesses (48%), 886 overuse injuries (repetitive mechanism, 30%) and 627 acute injuries (traumatic mechanism, 21%). Diagnostic codes were recorded for 2829 (97%) of health problems. Athletes reported, on average, 5.9 new health problems per year (95% CI: 5.6 to 6.1), including 1.3 acute injuries (CI: 1.2 to 1.4), 1.7 overuse injuries (CI: 1.6 to 1.9) and 2.9 illnesses (CI: 2.7 to 3.0). Each year, female and male athletes lost an average of 40 and 26 days of training and competition due to health problems, respectively. The diagnoses with the highest health burden were anterior cruciate ligament rupture, respiratory infection, lumbar pain and patellar tendinopathy.ConclusionThe injury burden was particularly high among female athletes and in team sports, whereas endurance sports had the greatest burden of illness. Our data provide a compelling argument for prioritising medical care and investing in prevention programmes not just during the Olympic Games, but also the preparation period.
Journal Article
Fatty Acids Composition and HIV Infection: Altered Levels of n-6 Polyunsaturated Fatty Acids Are Associated with Disease Progression
Fatty acids (FAs) are important regulators of immune responses and innate defense mechanisms. We hypothesized that disturbed FA metabolism could contribute to the progression of HIV infection. Plasma levels of 45 FAs were analyzed with gas chromatography in healthy controls and HIV-infected patients with regard to Mycobacterium avium complex (MAC) infection. In vitro, we assessed MAC-PPD-induced release of inflammatory cytokines in peripheral and bone marrow mononuclear cells (PBMC and BMMC) according to levels of n-6 polyunsaturated fatty acids (PUFAs). While plasma saturated FAs were higher in HIV infection, PUFAs, and in particular the n-6 PUFA arachidonic acid (AA), were lower in patients with advanced disease. The ratio between AA and precursor dihomo-γ-linolenic acid, reflecting Δ5-desaturase activity, was markedly lower and inversely correlated with plasma HIV RNA levels in these patients. Depletion of AA was observed prior to MAC infection, and MAC-PPD-induced release of TNF and IL-6 in PBMC and BMMC was lower in patients with low plasma AA. Our findings suggest that dysregulated metabolism of n-6 PUFAs may play a role in the progression of HIV infection. While high AA may contribute to chronic inflammation in asymptomatic HIV-infected patients, low AA seems to increase the susceptibility to MAC infection in patients with advanced disease.
Journal Article
Adverse events and in-hospital mortality: an analysis of all deaths in a Norwegian health trust during 2011
Background
The estimated number of in-hospitals deaths due to adverse events is often different when using data from deceased patients compared with that of a population experiencing adverse events.
Methods
The study was conducted at three hospitals in the Bergen Hospital Trust, including a 950-bed university hospital. The objective was to study the reported deaths and investigate the probable number of deaths caused by adverse events. Information about all patients who died in the hospitals during 2011 was retrieved from the electronic patient data management system and the medical records. All deaths were classified into two groups according to Norwegian law based on whether or not the death was sudden and/or unexpected. The cause of death in the latter group was further classified as being due to either natural or unnatural causes according to national requirements. An expert review panel screened the patient records for information regarding adverse events and possible (≥ 50%) preventability. Age, length of hospital stay, and Charlson Comorbidity Index were also registered.
Results
There were 59,605 unique patients admitted in 2011 and 1185 registered deaths (1.98%). The mean and median ages of the deceased were 73,8 and 78 years, respectively, and the median length of stay was 5.6 days (range). Of these deaths, 290 (24.5%) were considered sudden and/or unexpected and 218 were considered to be due to natural causes. Of the 72 unnatural deaths, 16 (1.4%) were classified as preventable or probably preventable. For 18 deaths (%) it was impossible to confirm or rule out preventability.
Conclusions
Using this method, we identified a small proportion of hospital deaths that could be classified as unnatural. Furthermore, there was a ≥ 50% chance or more that 34 deaths (2.9%) were due to causes that could have been prevented.
Journal Article