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1.
  • Hasselgren, Kristina, 1976- (author)
  • Colorectal Liver Metastases – Different Aspects on Treatment with Associated Liver Partition and Portal Vein Ligation for Staged Hepatectomy and on Portal Vein Occlusion
  • 2020
  • Doctoral thesis (other academic/artistic)abstract
    • Introduction: For patients with colorectal liver metastases (CRLM), the only treatment with a possibility for long-term survival and cure is radical resection. The majority of patients are at the time of diagnosis not assessed as resectable because they have advanced disease in the liver or unresectable extrahepatic disease or are too frail to withstand liver surgery. Patients who at the time of diagnosis are not assessed as resectable may be treated with conversion chemotherapy to downsize the tumor burden and render the patient eligible for resection. One concern with chemotherapy administered preoperatively has been the potential negative effect on the future liver remnant (FLR), especially for patients with a low volume of the FLR who are undergoing techniques to increase the volume. Established techniques to increase the volume are portal vein occlusion (PVO) and two-staged hepatectomy (TSH). A more recent method is Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS). Due to the relative novelty of ALPPS, the long-term oncological results are not known. For patients with CRLM, resection of liver metastases is more favorable from a health economic perspective than palliative treatment and results in a higher quality of life than palliative chemotherapy. For patients undergoing ALPPS as well as TSH, the data are scarce. Aim: The aim of the first study was to determine whether preoperative chemotherapy has a negative impact on the volume increase for patients undergoing ALPPS. The aim of the second study was to analyze the temporal course of the volume increase in the FLR for patients undergoing PVO. The aim of the third study was to study the long-term outcome for patients randomized to ALPPS or TSH. The aim of the fourth study was to perform a health economic analysis of patients randomized to ALPPS or TSH. Methods: The first study was based on data from the ALPPS registry, which is an international registry initiated 2012. All patients included in the registry between 2012 and 2016 were included. The patients were divided into the following four groups: no preoperative chemotherapy, 1 regimen of neoadjuvant chemotherapy, more than 1 regimen, and more than 1 regimen with the addition of monoclonal antibodies. The volume increase between interventions 1 and 2 was analyzed. In the second study, a retrospective analysis was performed of patients randomized to TSH. Forty-eight patients were included. The volume increase of the FLR was analyzed as the kinetic growth rate (KGR). The KGR was calculated from PVO until radical hepatectomy or exclusion, as well as between the first and second radiological evaluations. In the third and fourth studies, patients randomized to ALPPS and TSH were included. In the third study, survival, as well as factors affecting the outcome, were analyzed. In the fourth study, a calculation of resource use was performed, as was an analysis of health-related quality of life (HRQoL) for the groups. Results: In the first study, it was found that chemotherapy had no negative impact on the volume increase for patients undergoing ALPPS. In the second study, it was found that the volume increase of the FLR was largest the first week after ALPPS. In the third study, it was found that patients randomized to ALPPS had a longer survival than those randomized to TSH. Of the factors affecting the outcome, resection of liver metastases had a significant impact. In the fourth study, no significant difference could be found in resource use or HRQoL for patients randomized to ALPPS over TSH. Conclusion: Patients with advanced CRLM undergoing ALPPS should receive preoperative chemotherapy, if indicated. For those undergoing PVO, early evaluation is crucial to evaluate the volume increase, and for those with insufficient increase, additional techniques to increase the volume should be considered. Resection of liver metastases is an important factor to improve the outcome. Further studies are warranted to conclude whether ALPPS or TSH is most effective from a health economic perspective.
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3.
  • Axelsson, Matthias, et al. (author)
  • Long and Short-Term Effects of Hypothermic Machine Perfusion vs. Cold Storage on Transplanted Kidneys from Expanded Criteria Donors-A Matched Comparison Study
  • 2023
  • In: JOURNAL OF CLINICAL MEDICINE. - 2077-0383. ; 12:17
  • Journal article (peer-reviewed)abstract
    • Hypothermic machine perfusion (HMP) has been shown to reduce delayed graft function (DGF)-rates in kidneys from expanded criteria donors (ECD) and may increase graft survival compared with static cold storage (SCS). This single-center, retrospective observational study aimed to evaluate this effect. The primary endpoint was the DGF-rate, defined as the use of dialysis in the first postoperative week, excluding the first 24 h. The main secondary endpoint was graft survival at 5 years. Recipients of ECD-kidneys between 2013 and 2021 with =2 grafts were included (n = 438). The SCS-kidneys were marginal-matched by propensity score to the HMP-group for donor age, cold ischemia time, and graft number. Multivariable adjusted analysis for confounders in the unmatched cohort and caliper-based ID-matching constituted sensitivity analyses. HMP showed a trend to lower DGF-rate in the marginal-matched comparison (9.2% vs. 16.1%, p = 0.063). This was strengthened by a significant benefit observed for HMP in both the sensitivity analyses: an adjusted OR of 0.45 (95% CI: 0.24; 0.84; p = 0.012) in the multivariable analysis and DGF-rate of 8.7% vs. 17.4% (p = 0.024) after ID-matching. The 5-year graft survival rate was >90% in both groups, with no benefit using HMP (HR = 0.79; 95% CI:0.39-1.16; p = 0.52). Our results suggest that HMP may be effective in decreasing DGF-rates, however, without any significant benefit in graft survival.
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4.
  • Ekberg, Jana, 1964, et al. (author)
  • A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients
  • 2022
  • In: Kidney International Reports. - : Elsevier BV. - 2468-0249. ; 7:2, s. 259-269
  • Journal article (peer-reviewed)abstract
    • Introduction: Steroid-based immunosuppression after transplantation increases the risk of post-transplant diabetes mellitus (PTDM), with adverse effects on patient and graft survival. In the SAILOR study, we investigated the safety and efficacy of complete steroid avoidance in immunologically low-risk kidney recipients without diabetes on the current standard-of-care maintenance regimen with tacrolimus/mycophenolate mofetil (MMF). Methods: In this 2-year, multicenter, open-label trial, a total of 222 patients were randomized to receive either steroid avoidance protocol (tacrolimus/MMF/antithymocyte globulin [ATG] induction [n = 113]) or steroid maintenance protocol (tacrolimus/MMF/prednisolone/basiliximab-induction [n = 109]). Results: At 1 year, no significant differences were found between steroid avoidance and steroid maintenance arms in the incidence of PTDM, the primary end point (12.4% vs. 18.3%, respectively, P = 0.30, CI: 16.3–4.4), or in overall biopsy-proven rejections (15% vs. 13.8%, respectively, P = 0.85). At 2 years, the composite end point of freedom from acute rejection, graft loss, and death (81% vs. 85%, respectively, P = 0.4), kidney function, or adverse events was comparable between the 2 arms. Moreover, 63.9% of the patients in the steroid avoidance arm remained free from steroids at 2 years. Conclusion: The SAILOR study provides further evidence for the feasibility, safety, and efficacy of early steroid-free treatment at 2 years in immunologically low-risk kidney recipients with tacrolimus/MMF maintenance regimen. © 2021 International Society of Nephrology
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5.
  • Erlandsson, H., et al. (author)
  • Observational study of risk factors associated with clinical outcome among elderly kidney transplant recipients in Sweden - a decade of follow-up
  • 2021
  • In: Transplant International. - : Frontiers Media SA. - 0934-0874 .- 1432-2277. ; 34:11, s. 2363-2370
  • Journal article (peer-reviewed)abstract
    • Kidney transplantation (Ktx) in elderly has become increasingly accepted worldwide despite their higher burden of comorbidities. We investigated important risk factors affecting long-term patient and graft survival. We included all (n = 747) Ktx patients >60 years from 2000 to 2012 in Sweden. Patients were age-stratified, 60-64, 65-69 and >70 years. Follow-up time was up to 10 years (median 7.9 years, 75% percentile >10 years). Primary outcome was 10-year patient survival in age-stratified groups. Secondary outcomes were 5-year patient and graft survival in age-stratified groups and the impact of risk factors including Charlson comorbidity index (CCI) on patient and graft survival. Mortality was higher in patients >70 years, after 10 years (HR 1.94; 95% CI 1.24-3.04; P = 0.004). Males had a higher 10-year risk of death (HR 1.39; CI 95% 1.04-1.86; P = 0.024). Five-year patient survival did not differ between age groups. In multivariate Cox analysis (n = 500), hazard ratio for 10-year mortality was 4.6 in patients with CCI >= 7 vs. <4 (95% CI 2.42-8.62; P = 0.0001). Higher CCI identified ESKD patients with 4.6 times higher risk of death after Ktx. We suggest that this index should be used as a part of the preoperative evaluation in elderly.
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6.
  • Fagernäs, Simon, et al. (author)
  • What do users think about Virtual Reality relaxation applications? A mixed methods study of online user reviews using natural language processing
  • 2021
  • In: Internet Interventions. - : Elsevier BV. - 2214-7829. ; 24
  • Journal article (peer-reviewed)abstract
    • The advent of affordable Virtual Reality (VR) technology has spurred consumer and commercial interest in VR relaxation applications, which has quickly grown into a popular non-gaming genre on digital marketplaces. While laboratory studies have demonstrated efficacy of VR relaxation for mental health purposes, little is known about how users experience this type of intervention and no study has examined the reception of consumer versions among regular users in everyday life. Studying published user reviews offers a unique window into naturalistic user experiences that complements traditional qualitative methods by circumventing the sampling bias of interview studies, and allowing analyses on full samples, unconstrained by coding resources. Using an innovative, semi-automated Natural Language Processing technique, the current study analyzed 1379 published reviews (including star ratings) of 30 different VR relaxation applications available for the Oculus Go and Gear VR. The uncovered topic structure and sentiment analysis thereof suggests that users have an overall positive view of VR relaxation applications, describing them as successful in inducing immersion and relaxation, and having appreciated gamification elements. However, perceived quality varied substantially between applications that explained more variance in star ratings than specific features. Critical issues raised were both technical (e.g. “overheating”) in nature and related to specific design elements and use. Implications for the design of consumer VR applications and future research are discussed.
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7.
  • Forsström, David, et al. (author)
  • Gamblers' Perception of the Playscan Risk Assessment : A Mixed-Methods Study
  • 2022
  • In: Journal of Gambling Studies. - : Springer Science and Business Media LLC. - 1050-5350 .- 1573-3602. ; 38:2, s. 591-606
  • Journal article (peer-reviewed)abstract
    • Responsible gambling (RG) tools are globally widespread; they aim to prevent or decrease the harm caused by gambling. However, existing research suggests that several included features do not decrease gambling or significantly reduce the subsequent harm. Most of the previous studies have used gambling data to understand the changes in gambling behavior. However, the literature lacks research regarding gamblers' experience and perception of RG tools, which may provide insight into increasing the usage and effectiveness of RG tools. This mixed-methods study aimed to explore gamblers' perception of their risk assessment in the RG tool Playscan regarding developing harmful gambling problems. Overall, 757 participants rated the perceived accuracy of their risk assessment and their perception of the overall RG tool that conducted the assessment. Participants were also allowed to leave a comment providing feedback, which was analyzed using thematic analysis. Quantitative data was analyzed using logistic regression and structural equation modeling. Qualitative analyses revealed that most of the participants were pleased with the risk assessment and found it helpful. Moderated mediation analysis showed that participants' assessment agreement partially mediated the association between expressing a negative view and their general view of Playscan. These results highlight the need to decrease the level of disagreement for promoting a better general view of RG tools to potentially increase their usage and effectiveness.
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8.
  • Forsström, David, et al. (author)
  • GamTest : Psychometric Evaluation in a Low-Gambling General Population
  • 2020
  • In: Journal of Gambling Issues. - Toronto : Concurrent Disorders Society Press. - 1910-7595. ; 44, s. 77-102
  • Journal article (peer-reviewed)abstract
    • Instruments that investigate different aspects of gambling activities are needed to distinguish negative consequences. Because gambling is a complex activity that occurs both offline and online, different questionnaires are necessary for screening and risk classification. GamTest, an instrument used by several gambling companies, was designed to cover different aspects of gambling: money and time spent, as well as social, financial, and emotional consequences. This study explores GamTest’s psychometric properties in a general population. A total of 2,234 Swedish respondents completed an online survey containing demographic questions, the questionnaire (GamTest), and the Problem Gambling Severity Index (PGSI). A confirmatory factor analysis was performed and GamTest’s reliability and validity tested. The confirmatory factor analysis yielded an inclusive fit. The internal consistency (omega) for the five factors was high (.79–.91), indicating good reliability, and a high positive correlation with the PGSI supported the validity of the GamTest. The inclusive fit of the confirmatory factor analysis can be explained by the low endorsement of negative consequences of gambling in the sample. However, GamTest seems to have good reliability and validity. The utility of GamTest is discussed in relation to its psychometric properties and its use in the responsible gambling tool Playscan.
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9.
  • Forsström, David, 1981-, et al. (author)
  • Psychometric properties of the Jonsson-Abbott Scale : Rasch and confirmatory factor analyses
  • 2022
  • In: Frontiers in Psychology. - : Frontiers Media SA. - 1664-1078. ; 13
  • Journal article (peer-reviewed)abstract
    • Measuring and assessing the different aspects of gambling behavior and its consequences is crucial for planning prevention, treatment, and understanding the development of at-risk and problem gambling. Studies indicate that instruments measuring problem gambling produce different results based on the characteristics of the population assessed. To accurately measure at-risk and problem gambling behavior, especially in a low-risk population, measures must cover a wider set of dimensions than the negative consequences already manifest. The Jonsson-Abbott Scale (JAS) includes items that cover overconsumption, actions that reinforce gambling behavior, and belief in gambling fallacies, based on a three-factor structure and has previously demonstrated good psychometric properties. However, there is a need to investigate how the instrument also functions in low-risk populations. This study aims to do so using both confirmatory factor and Rasch analysis; this research included 1,413 Swedish participants who endorsed at least one JAS item. The results replicated the previous three-factor solution and indicated that the instrument had good reliability. In addition, the results demonstrated that the three factors are independent, and the overall score per factor needs to be analyzed. In summary, the JAS appears suitable for use in low-risk populations to measure various aspects of gambling behavior.
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10.
  • Hlynsson, Jón Ingi, et al. (author)
  • Exploring cutoff points and measurement invariance of the Brunnsviken brief quality of life inventory
  • 2024
  • In: Frontiers in Psychology. - 1664-1078. ; 14
  • Journal article (peer-reviewed)abstract
    • Introduction: Quality of life (QoL) can be defined as the goodness of life, beyond simply absence of disease or functional impairments, self-rating scales of which capture valuable information beyond change in primary outcomes. This study (n = 3,384) validated the Brunnsviken Brief Quality of Life Inventory (BBQ) across divergent groups by evaluating its measurement invariance (MI). We hypothesized measurement invariance for the BBQ across age groups, genders, depression, and anxiety severity. Potential cutoff points for the BBQ were also explored.Method: Confirmatory factor analysis (CFA) models were fit to sample data obtained from an ongoing study on transdiagnostic internet-based treatment modules. Parameters were successively constrained to assess configural, metric, scalar, and residual invariance factor structures across different groups.Results: The BBQ demonstrated MI at the metric level and partial MI at the scalar level across all these groups, which remained stable at the strict-residual level for all groups except for genders. These results remained stable after correcting for unbalanced group sizes for gender, clinical–subclinical levels of depression, and clinical–subclinical levels of anxiety. A cutoff point analysis revealed that a BBQ total scores below 39 was associated with notable psychopathology.Discussion: The BBQ is a reliable measure of QoL that is applicable for various divergent groups (e.g., vulnerable persons), and thus a viable instrument for use in healthcare and research with minimal aversive impact.Clinical trial registration: NCT05016843.
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11.
  • Hlynsson, Jón Ingi, et al. (author)
  • Let's talk about digital mental health assessment : Utilizing PHQ-2 and GAD-2 for in-treatmentmonitoring & BBQ and QWB for outcome evaluation in internet interventions
  • 2024
  • In: SweSRII 2024. ; , s. 14-14
  • Conference paper (peer-reviewed)abstract
    • INTRODUCTION: In internet-based mental health research, the efficacy of assessment tools is pivotal. Extensive questionnaires often deter participant completion, undermining data integrity. This presentation focuses on the application of brief yet effective measures: The PHQ-2 and GAD-2 as ultra-brief measures for psychopathology, and Brunnsviken brief quality of life inventory (BBQ) and Questionnaire on Well-Being (QWB) as positively valanced measures for positive functioning. By prioritizing instruments with concise formats and positive framing, such as the BBQ and QWB, our research aims to enhance response rates and data quality. We explore psychometric findings from various internet-based trials, demonstrating the utility of these measures in capturing in-treatment fluctuations and informing treatment outcomes. METHOD: We outline findings from three studies at different stages of development. Primary statistics are obtained from ROC curve and factor analyses. RESULTS: Preliminary results suggest that brief measures like the PHQ-2 and GAD-2 can monitor in-treatment fluctuations in symptoms as effectively as their full-scale equivalents. The BBQ, indicating positive functioning, can validly assess divergent subgroups (e.g., vulnerable persons). Notably, BBQ total scores below 39 are linked with significant psychopathology. Preliminary results for the QWB indicate total scores are negatively associated with psychopathology and positively correlated with positive affect. CONCLUSIONS: Ultra-brief measures of psychopathology are too often used incorrectly; usage is recommended to be bound to in-treatment monitoring of treatment outcomes. Collecting data more frequently through concise surveys can provide insights into the mechanisms driving change. Treatment trials often overlook positive functioning. Thus, we encourage using the BBQ and QWB as they are psychometrically valid, freely available, and inform treatment outcomes beyond standard measures of psychopathology.
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12.
  • Ivanova, Ekaterina, 1987- (author)
  • Responsible provision of online gambling : Effects, usability and gamblers’ experiences of protective measures implemented in online gambling environments
  • 2020
  • Doctoral thesis (other academic/artistic)abstract
    • Problem gambling is considered a public health problem in many countries and is associated with serious financial and health-related harms for both problem gamblers and significant others. It is possible to create gambling environments that would promote sustainable gambling behaviors and prevent excessive gambling. However, research on the effectiveness of tools for responsible provision of gambling is scarce and the quality of the research is low. Also, there exists a conflict of interest between making a profit when providing gambling and protecting vulnerable customers. The general aim of the project was to study the effects, usability and gamblers’ experiences of tools for responsible provision of online gambling. Study I evaluated the effects of a prompt to set voluntary deposit-limit of optional size among 4,328 customers of an online gambling platform. During the data collection period, all customers from Finland registering an account on the gambling platform were randomized into being prompted to set a deposit-limit either 1) at-registration, 2) before their first deposit, 3) after their first deposit or 4) to an unprompted control group. Gambling intensity, measured with aggregated net loss, was tracked during 90 days after registration. No differences in gambling intensity between the intervention and control groups were found neither on the whole-group level (B (95% CI) =-0.080 (-0.229-0.069), p=.291), nor in the subgroup of the most involved gamblers (B (95% CI) =0.042(-0.359-0.442), p=.838). Study II aimed at predicting gaming freeze (as a proxy parameter for problem gambling) in online gamblers. For the sample of N=2,618 (N=1,309 freezers), a total of 105 predictors were created based on the data tracked by the gambling platform. The analysis was carried out using the machine learning method Random Forest. The predictive accuracy of the model applied to the dataset was 0.615, with a specificity of 0.686 and a sensitivity of 0.543. Study III aimed at investigating non-problem gamblers’ experiences of protective measures. A total of N=10,200 active customers of an online gambling platform were asked to rate their previous experiences of protective tools, their inclination to abandon a gambling service due to perceived overexposure to protective measures and answer questions on their symptoms of problem gambling. N=1,223 responded to the questionnaire, with the majority of the sample being moderate-risk gamblers (38.5%), followed by low-risk gamblers (26.8%), non-problem gamblers (18.9%) and problem gamblers (15.8%). In general, non-problem gamblers were not more disturbed by protective measures than other categories of gamblers. More problem gamblers have previously abandoned a gambling service due to perceived overexposure to protective measures compared to non-problem gamblers (OR(95% CI)= 7.17(3.61-14.23), p<.001). In conclusion, a prompt to set a voluntary deposit-limit of optional size did not appear to be effective in decreasing gambling intensity in online gamblers, indicating the need of evaluating alternative designs. Predicting gaming freezes in the current project resulted in a low accuracy, indicating that gaming freeze is not suitable as a proxy measurement for problem gambling and suggesting the need for collecting subjective data on symptoms of problem gambling. The results of Study III suggest that protective measures can be tested and implemented without the risk of disturbing recreational gamblers.
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13.
  • Johansson, Junko, 1989, et al. (author)
  • Isolated limb perfusion with melphalan activates interferon-stimulated genes to induce tumor regression in patients with melanoma in-transit metastasis
  • 2020
  • In: Oncoimmunology. - 2162-402X. ; 9:1
  • Journal article (peer-reviewed)abstract
    • Hyperthermic isolated limb perfusion (ILP) with high-dose melphalan is a treatment option for melanoma patients with metastasis confined to limbs (in-transit metastasis). The therapy entails a complete response (CR) rate of 50-70%. Cellular immunity is proposed to impact on the clinical efficacy of ILP, but the detailed aspects of ILP-induced immune activation remain to be explored. For this study, we explored the potential role of interferon-stimulated gene (ISG) products, including CXCL10, CCL2, PD-L2 and IFN-gamma along with expression of their cognate receptors CXCR3, CCR4, CCR5 and PD-1 on lymphocytes, for the clinical efficacy of ILP. Patients with high serum levels of CXCL10, CCL2, PD-L2 and IFN-gamma were more likely to achieve CR after ILP. Additionally, the expression of CXCR3, CCR4 and CCR5 on T cells and/or natural killer (NK) cells was enhanced by ILP. Peripheral blood mononuclear cells (PBMCs) secreted high levels of CXCL10, CCL2 and IFN-gamma in response to co-culture with melphalan-exposed melanoma cells in vitro. Activated T cells migrated toward supernatants from these co-cultures. Furthermore, melphalan-exposed melanoma cells triggered upregulation of CXCR3, CCR4, CCR5 and PD-1 on co-cultured T cells and/or NK cells. Our results suggest that constituents released from melphalan-exposed melanoma cells stimulate the ISG axis with ensuing formation of chemokines and upregulation of chemokine receptor expression on anti-neoplastic immune cells, which may contribute in ILP-induced tumor regression.
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14.
  • Johansson, Junko, 1989, et al. (author)
  • Presence of tumor-infiltrating CD8(+) T cells and macrophages correlates to longer overall survival in patients undergoing isolated hepatic perfusion for uveal melanoma liver metastasis
  • 2020
  • In: OncoImmunology. - : Informa UK Limited. - 2162-402X. ; 9:1
  • Journal article (peer-reviewed)abstract
    • Uveal melanoma is a malignant tumor of the eye that often metastasizes to the liver conferring poor prognosis. When comparing immune profiles in peripheral blood of untreated patients with uveal melanoma liver metastasis and healthy blood donors, it was observed that immune cells of uveal melanoma patients carried immunosuppressive features. Patient blood contained an increased content of CD14(+)HLA-DR-/low M-MDSCs and inflammatory CD16(+) monocytes, while their dendritic cells expressed lower levels of activation markers. Melanoma patients also harbored an enhanced fraction of CD4(+)Foxp3(+) regulatory T cells, while their effector T cells expressed lower levels of the activation marker HLA-DR. Biopsies from liver metastases were obtained from patients with uveal melanoma that subsequently underwent hyperthermic isolated hepatic perfusion (IHP) with melphalan. There were trends indicating a positive correlation between a high infiltration of CD8(+) T cells in metastases and an activated immune cell profile in blood. High metastatic infiltration of CD8(+) T cells and CD68(+) macrophages, but not of immunosuppressive CD163(+) macrophages, correlated to a longer overall survival in patients treated with IHP. Hence, while the immune system of patients with uveal melanoma shows signs of immunosuppression, the presence of activated immune cells may correlate to a longer survival, at least following IHP treatment.
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15.
  • Jonsson, Jakob, et al. (author)
  • Offering an auto-play feature likely increases total gambling activity at online slot-machines : preliminary evidence from an interrupted time series experiment at a real-life online casino
  • 2024
  • In: Frontiers in Psychiatry. - 1664-0640. ; 15
  • Journal article (peer-reviewed)abstract
    • Auto-play is a ubiquitous feature in online casino gambling and virtual slot machines especially, allowing gamblers to initiate spin sequences of pre-set length and value. While theoretical accounts diverge on the hypothesized causal effect on gambling behavior of using the auto-play feature, observational findings show that this feature is used to a higher degree by problem and/or high-intensity gamblers, suggesting that banning this feature may constitute a global responsible gambling measure. Direct, experimental research on causal effects of offering auto-play at online casinos is however lacking. Here, we report the findings of an interrupted time series experiment, conducted at a real-life online casino in Sweden, in which the auto-play feature was made available during a pre-set duration on 40 online slot machines, with 40 matched slots serving as control. Aggregated time series on daily betted amount, spins and net losses were analyzed using a structural Bayesian framework that compared observed developments during the peri-intervention period to modeled counterfactual estimates. Results suggest that offering an auto-play feature on online casinos likely increases total gambling activity in terms of betted amount (approx.+ 7-9%) and (perhaps) number of spins (approx. +3%) but has no effect on net losses. Limitations of studying auto-play effects on a population-level, as well as the complexities of banning this feature within a complex ecosystem of non-perfect channelization to licensed providers, are discussed, including suggestions for future research.
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16.
  • Karlsson, Joakim, et al. (author)
  • Molecular profiling of driver events in metastatic uveal melanoma
  • 2020
  • In: Nature Communications. - : Springer Science and Business Media LLC. - 2041-1723. ; 11:1
  • Journal article (peer-reviewed)abstract
    • Metastatic uveal melanoma is less well understood than its primary counterpart, has a distinct biology compared to skin melanoma, and lacks effective treatments. Here we genomically profile metastatic tumors and infiltrating lymphocytes. BAP1 alterations are overrepresented and found in 29/32 of cases. Reintroducing a functional BAP1 allele into a deficient patient-derived cell line, reveals a broad shift towards a transcriptomic subtype previously associated with better prognosis of the primary disease. One outlier tumor has ahigh mutational burden associated with UV-damage. CDKN2A deletions also occur, which are rarely present in primaries. A focused knockdown screen is used to investigate overexpressed genesassociated withcopy number gains. Tumor-infiltrating lymphocytes are in several cases found tumor-reactive, but expression of the immune checkpoint receptors TIM-3, TIGIT and LAG3 is also abundant. This study represents the largest whole-genome analysis of uveal melanoma to date, and presents an updated view of the metastatic disease. © 2020, The Author(s).
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17.
  • Lindner, Philip, et al. (author)
  • Experiences of Gamified and Automated Virtual Reality Exposure Therapy for Spider Phobia : Qualitative Study
  • 2020
  • In: JMIR Serious Games. - Toronto, ON, Canada : JMIR Publications Inc.. - 2291-9279. ; 8:2
  • Journal article (peer-reviewed)abstract
    • Background: Virtual reality exposure therapy is an efficacious treatment of anxiety disorders, and recent research suggests that such treatments can be automated, relying on gamification elements instead of a real-life therapist directing treatment. Such automated, gamified treatments could be disseminated without restrictions, helping to close the treatment gap for anxiety disorders. Despite initial findings suggesting high efficacy, very is little is known about how users experience this type of intervention.Objective: The aim of this study was to examine user experiences of automated, gamified virtual reality exposure therapy using in-depth qualitative methods.Methods: Seven participants were recruited from a parallel clinical trial comparing automated, gamified virtual reality exposure therapy for spider phobia against an in vivo exposure equivalent. Participants received the same virtual reality treatment as in the trial and completed a semistructured interview afterward. The transcribed material was analyzed using thematic analysis.Results: Many of the uncovered themes pertained directly or indirectly to a sense of presence in the virtual environment, both positive and negative. The automated format was perceived as natural and the gamification elements appear to have been successful in framing the experience not as psychotherapy devoid of a therapist but rather as a serious game with a psychotherapeutic goal.Conclusions: Automated, gamified virtual reality exposure therapy appears to be an appealing treatment modality and to work by the intended mechanisms. Findings from the current study may guide the next generation of interventions and inform dissemination efforts and future qualitative research into user experiences.
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18.
  • Lindner, Philip, et al. (author)
  • Gamified, Automated Virtual Reality Exposure Therapy for Fear of Spiders : A Single-Subject Trial Under Simulated Real-World Conditions
  • 2020
  • In: Frontiers in Psychiatry. - : Frontiers Media SA. - 1664-0640. ; 11
  • Journal article (peer-reviewed)abstract
    • Background: Virtual Reality exposure therapy (VRET) is an evidence-based treatment of phobias and recent research suggests that this applies also to self-contained, automated interventions requiring no therapist guidance. With the advent and growing adoption of consumer VR technology, automated VR intervention have the potential to close the considerable treatment gap for specific phobias through dissemination as consumer applications, self-help at clinics, or as blended treatment. There is however a lack of translational effectiveness studies on VRET treatment effects under real-world conditions.Methods: We conducted a single-arm (n = 25), single-subject study of automated, gamified VRET for fear of spiders, under simulated real-world conditions. After setup and reading instructions, participants completed the automated, single-session treatment by themselves. Self-rated fear of spiders and quality of life served as outcome measures, measured twice before, and one and two weeks after treatment, and at a six-month follow-up. Session characteristics and user experience measures were collected at the end of the session.Results: Mixed-effects modeling revealed a significant and large (d = 1.26) effect of treatment-onset on phobia symptoms (p < .001), and a small (d = 0.49) effect on quality of life (p = .025). Results were maintained at a six-month follow-up (p > .053). The intervention was tolerable and practical. There were no significant correlations between any user experience measure and decrease in phobia symptoms (p > .209).Conclusions: An automated VRET intervention for fear of spiders showed equivalent effects on phobia symptoms under effectiveness conditions as previously reported under efficacy conditions. These results suggest that automated VRET applications are promising self-help treatments also when provided under real-world conditions.
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19.
  • Lindner, Philip, et al. (author)
  • Is Continued Improvement After Automated Virtual Reality Exposure Therapy for Spider Phobia Explained by Subsequent in-vivo Exposure? : A First Test of the Lowered Threshold Hypothesis
  • 2021
  • In: Frontiers in Psychiatry. - : Frontiers Media SA. - 1664-0640. ; 12
  • Journal article (peer-reviewed)abstract
    • Consumer Virtual Reality (VR) technology offers a powerful, immersive medium for scalable dissemination of mental health interventions. Decades of research has shown VR exposure therapy to be efficacious in the treatment of anxiety disorders and that the fear reduction generalizes to real-world stimuli. Many studies also report continued improvement over time, after discontinuing VR use. The lowered threshold hypothesis states that this continued improvement is moderated by lowering the threshold to conduct subsequent in-vivo exposure. The current study is the first to formally test this hypothesis, using data from a recent trial on automated VR exposure therapy for spider phobia, in which participants (n = 49) were followed for 1 year, completing assessments 1 week, 3 and 12 months post-treatment. The assessment included validated self-report of phobia symptoms, a standardized behavioral approach test featuring a real spider, and a questionnaire for self-reporting frequency of in-vivo exposures since last assessment. Number of in-vivo exposures was found to be independently associated with greater symptom decrease in longitudinal outcome models. In sequential structural equation models, immediate post-treatment symptom reduction was associated with subsequent in-vivo exposures, which in turn was associated with continued symptom reduction. However, this applied only to self-reported phobia symptoms (not behavioral avoidance) and no associations were found past 3 months. Our findings offer preliminary, partial support for the lowered threshold hypothesis, suggesting that VR exposure interventions may benefit from including explicit in-virtuo to in-vivotransitioning components.
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20.
  • Lindner, Philip, et al. (author)
  • Studying Gambling Behaviors and Responsible Gambling Tools in a Simulated Online Casino Integrated With Amazon Mechanical Turk : Development and Initial Validation of Survey Data and Platform Mechanics of the Frescati Online Research Casino
  • 2021
  • In: Frontiers in Psychology. - : Frontiers Media SA. - 1664-1078 .- 1664-0640. ; 11
  • Journal article (peer-reviewed)abstract
    • Introduction: Online gambling, popular among both problem and recreational gamblers, simultaneously entails both heightened addiction risks as well as unique opportunities for prevention and intervention. There is a need to bridge the growing literature on learning and extinction mechanisms of gambling behavior, with account tracking studies using real-life gambling data. In this study, we describe the development and validation of the Frescati Online Research Casino (FORC): a simulated online casino where games, visual themes, outcome sizes, probabilities, and other variables of interest can be experimentally manipulated to conduct behavioral analytic studies and evaluate the efficacy of responsible gambling tools.Methods: FORC features an initial survey for self-reporting of gambling and gambling problems, along with several games resembling regular real-life casino games, designed to allow Pavlovian and instrumental learning. FORC was developed with maximum flexibility in mind, allowing detailed experiment specification by setting parameters using an online interface, including the display of messages. To allow convenient and rapid data collection from diverse samples, FORC is independently hosted yet integrated with the popular crowdsourcing platform Amazon Mechanical Turk through a reimbursement key mechanism. To validate the survey data quality and game mechanics of FORC, n = 101 participants were recruited, who answered an questionnaire on gambling habits and problems, then played both slot machine and card-draw type games. Questionnaire and trial-by-trial behavioral data were analyzed using standard psychometric tests, and outcome distribution modeling.Results: The expected associations among variables in the introductory questionnaire were found along with good psychometric properties, suggestive of good quality data. Only 6% of participants provided seemingly poor behavioral data. Game mechanics worked as intended: gambling outcomes showed the expected pattern of random sampling with replacement and were normally distributed around the set percentages, while balances developed according to the set return to player rate.Conclusions: FORC appears to be a valid paradigm for simulating online gambling and for collecting survey and behavioral data, offering a valuable compromise between stringent experimental paradigms with lower external validity, and real-world gambling account tracking data with lower internal validity.
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21.
  • Lindner, Philip, et al. (author)
  • Transitioning Between Online Gambling Modalities and Decrease in Total Gambling Activity, but No Indication of Increase in Problematic Online Gambling Intensity During the First Phase of the COVID-19 Outbreak in Sweden : A Time Series Forecast Study
  • 2020
  • In: Frontiers In Public Health. - : Frontiers Media SA. - 2296-2565. ; 8
  • Journal article (peer-reviewed)abstract
    • Introduction: The COVID-19 outbreak will likely have a public health impact beyond immediate disease transmission. Little is known about whether social distancing and other societal changes has provoked an increase in gambling, whether decreased betting opportunities due to paused sports events spurred gamblers to transition to online casino gambling, or whether any of these factors have had an impact on problem gambling.Methods: Data on lookup queries against the Swedish Gambling Paus registry, logging all initiated gambling sessions by all licensed gambling providers, from 2019-01-01 (start of registry) to 2020-04-08 (well into the first phase of the outbreak) were analyzed using TBATS time series forecasting to estimate trends after the first domestic COVID-19 death. Obfuscated data on daily total wagered and deposited amounts, split by modality (casino or betting, and low and high intensity, respectively) for the equivalent period were supplied by a licensed online gambling provider.Results: Total gambling activity decreased by 13.29% during the first phase of the outbreak compared to forecast. Analyses of online gambling data revealed that although betting decreased substantially in synchrony with a slight increase in online casino gambling, there was no increase in likely problematic, high-intensity gambling and neither did total online gambling increase.Conclusions: This first, preliminary study revealed no increase in Swedish gambling activity, total or specifically online, in the first phase of the COVID-19 outbreak. Future research should examine whether pandemic-induced transitioning between gambling modalities and/or increased participation in gambling, leads to long-term effects on prevalence of problem gambling.
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22.
  • Lindner, Philip, et al. (author)
  • Virtual Reality exposure therapy for public speaking anxiety in routine care : a single-subject effectiveness trial
  • 2021
  • In: Cognitive Behaviour Therapy. - : Informa UK Limited. - 1650-6073 .- 1651-2316. ; 50:1, s. 67-87
  • Journal article (peer-reviewed)abstract
    • Virtual Reality (VR) can be used as a therapeutic tool to conduct efficacious in-session exposure therapy by presenting virtual equivalents of phobic stimuli, yet past hardware restrictions hindered implementation in routine care and effectiveness studies. The current study examines the effectiveness of a VR-assisted treatment protocol for public speaking anxiety with demonstrated efficacy, this time in routine care, using affordable VR hardware. Participants (n = 23) were recruited via a private clinic and treated by one of four psychologists with only minimal VR-training. Using a single-subject design and dual-slope modeling (adjusting the treatment-onset slope for treatment effects), we found a significant, large decrease in self-rated public speaking anxiety following the primary three-hour session, similar in magnitude to the previous efficacy trial. Multilevel modeling of in-session process measures suggests that the protocol works as intended, by decreasing catastrophic belief expectancy and distress, and increasing perceived performance quality. Adherence to the online transition program that followed-encouraging in-vivo exposure-was relatively poor, yet symptoms decrease continued. No change was observed over the three-month follow-up period. We conclude that VR exposure therapy can be effective under routine care conditions and is an attractive approach for future, large-scale implementation and effectiveness trials.
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23.
  • Ma, Lichen, et al. (author)
  • Integrating virtual realities and psychotherapy : SWOT analysis on VR and MR based treatments of anxiety and stress-related disorders
  • 2021
  • In: Cognitive Behaviour Therapy. - : Informa UK Limited. - 1650-6073 .- 1651-2316. ; 50:6, s. 509-526
  • Journal article (peer-reviewed)abstract
    • The use of virtual reality (VR) and mixed reality (MR) technology in clinical psychology is growing. Efficacious VR-based treatments for a variety of disorders have been developed. However, the field of technology-assisted psychotherapy is constantly changing with the advancement in technology. Factors such as interdisciplinary collaboration, consumer familiarity and adoption of VR products, and progress in clinical science all need to be taken into consideration when integrating virtual technologies into psychotherapies. We aim to present an overview of current expert opinions on the use of virtual technologies in the treatment of anxiety and stress-related disorders. An anonymous survey was distributed to a select group of researchers and clinicians, using an analytic framework known as Strengths, Weaknesses, Opportunities, and Threats (SWOT). Overall, the respondents had an optimistic outlook regarding the current use as well as future development and implementation of technology-assisted interventions. VR and MR psychotherapies offer distinct advantages that can overcome shortcomings associated with traditional therapy. The respondents acknowledged and discussed current limitations of VR and MR psychotherapies. They recommended consolidation of existing knowledge and encouraged standardisation in both theory and practice. Continued research is needed to leverage the strengths of VR and MR to develop better treatments.
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24.
  • Menkveld, Albert J., et al. (author)
  • Nonstandard Errors
  • 2024
  • In: JOURNAL OF FINANCE. - : Wiley-Blackwell. - 0022-1082 .- 1540-6261. ; 79:3, s. 2339-2390
  • Journal article (peer-reviewed)abstract
    • In statistics, samples are drawn from a population in a data-generating process (DGP). Standard errors measure the uncertainty in estimates of population parameters. In science, evidence is generated to test hypotheses in an evidence-generating process (EGP). We claim that EGP variation across researchers adds uncertainty-nonstandard errors (NSEs). We study NSEs by letting 164 teams test the same hypotheses on the same data. NSEs turn out to be sizable, but smaller for more reproducible or higher rated research. Adding peer-review stages reduces NSEs. We further find that this type of uncertainty is underestimated by participants.
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25.
  • Miloff, Alexander, et al. (author)
  • Measuring Alliance Toward Embodied Virtual Therapists in the Era of Automated Treatments With the Virtual Therapist Alliance Scale (VTAS) : Development and Psychometric Evaluation
  • 2020
  • In: Journal of Medical Internet Research. - Toronto, ON, Canada : JMIR Publications Inc.. - 1438-8871. ; 22:3
  • Journal article (peer-reviewed)abstract
    • Background: Automated virtual reality exposure therapies (VRETs) are self-help treatments conducted by oneself and supported by a virtual therapist embodied visually and/or with audio feedback. This simulates many of the nonspecific relational elements and common factors present in face-to-face therapy and may be a means of improving adherence to and efficacy of self-guided treatments. However, little is known about alliance toward the virtual therapist, despite alliance being an important predictor of treatment outcome.Objective: In this study, we aimed to evaluate the first alliance instrument developed for use with embodied virtual therapists in an automated treatment format—the Virtual Therapist Alliance Scale (VTAS)—by (1) assessing its psychometric properties, (2) verifying the dimensionality of the scale, and (3) determining the predictive ability of the scale with treatment outcome.Methods: A psychometric evaluation and exploratory factor analysis of the VTAS was conducted using data from two samples of spider-fearful patients treated with VRET and the help of an embodied, voice-based virtual therapist (n=70). Multiple regression models and bivariate correlations were used to assess the VTAS relationship with treatment outcome, according to self-reported fear and convergence with presence and user-friendliness process measures.Results: The VTAS showed a sound two-factor solution composed of a primary factor covering task, goal, and copresence; adequate internal consistency; and good convergent validity, including moderate correlation (r=.310, P=.01) with outcomes over follow-up.Conclusions: These preliminary results suggest that alliance toward a virtual therapist is a significant predictor of treatment outcome, favors the importance of a task-goal over bond-factor, and should be explored in studies with larger sample sizes and in additional forms of embodiment.
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26.
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27.
  • Molander, Olof, et al. (author)
  • Internet-based cognitive behavior therapy for problem gambling in routine care : protocol for a non-randomized pilot and feasibility trial
  • 2020
  • In: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6
  • Journal article (peer-reviewed)abstract
    • Background: Problem gambling and gambling disorder are major public health concerns worldwide, and awareness of associated negative consequences is rising. In parallel, treatment demand has increased, and Internet interventions offer a promising alternative for providing evidence-based treatment at scale to a low cost.Method: We developed a novel Internet-delivered cognitive behavioral treatment for gambling, based on qualitative interviews with treatment-seeking gamblers, behavioral research on gambling behavior, and the pathway model for problem gambling. This research protocol describes a non-randomized pilot and feasibility trial conducted in routine addiction care with adult treatment-seeking patients (max N = 25) with problem gambling. The primary aim is to ensure acceptability and safety, measured by satisfaction, credibility, working alliance, and possible negative effects. Secondary aims are feasibility of study procedures in terms of recruitment and measurement procedures as well as potential effectiveness measured weekly by gambling symptoms as primary outcome and gambling behavior, quality of life, symptoms of depression and anxiety, alcohol, and drug use as secondary outcomes. Potential mediators measured weekly are loss of control, verbal rules, and well-being.Discussion: This study is innovative in several respects, regarding both treatment development and implementation. The results of the study will guide a future randomized controlled trial, as well as the development of the intervention and intervention implementation within ordinary addiction care.Trial registration: Clinical trials.gov, NCT ID: NCT03946098. Registered 10 May 2019
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28.
  • Norén, Åsa, et al. (author)
  • End-ischemic hypothermic oxygenated machine perfusion does not improve renal outcome following liver transplantation from aged donors: A single-center retrospective report
  • 2023
  • In: ARTIFICIAL ORGANS. - 0160-564X .- 1525-1594. ; 47:12, s. 1854-1864
  • Journal article (peer-reviewed)abstract
    • Background: Organ transplantation using grafts from elderly donors entails a higher risk for severe ischemia-reperfusion injury (IRI). Advanced IRI after liver transplantation (LT) seems to be associated with the development of acute kidney injury (AKI). We studied if end-ischemic hypothermic oxygenated machine perfusion (HOPE) of liver grafts, aimed at mitigating liver IRI, impacts on the frequency and severity of AKI after LT. Methods: LTs performed at our center between January 2017 and December 2022 using organs from deceased brain-dead donors aged 70 or older were reviewed. From November 2020 on, HOPE was performed routinely in this donor category. The frequency and severity of AKI (KDIGO criteria) within 48 hours of graft reperfusion and the model of early allograft function (MEAF) were compared between HOPE-LTs (n = 30) and control LTs (n = 71). Results: AKI developed in 23/30 (77%) HOPE-LTs and in 40/71 (56%) control LTs (p = n.s.), with no difference in severity and timing between groups. Renal replacement therapy was required in 3/30 (10%) HOPE-LTs and 6/71 (8%) control LTs. In addition, transaminase leak during the first week (marker of IRI) and MEAF were similar between groups. These findings persisted after propensity matching. Histology showed more hepatocyte vacuolization and higher Suzuki score in HOPE-LTs. Although this analysis could have been underpowered, no trends supporting the benefit of HOPE on liver and renal injury after LT were ever identified. Conclusions: In conclusion, HOPE in this group of older donors does not seem to improve either graft IRI, or the incidence of early AKI after LT.
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29.
  • Nourbakhsh, Nima, et al. (author)
  • Effects of Corticosteroid Treatment on Mycophenolic Acid Exposure in Renal Transplant Patients—Results From the SAILOR Study
  • 2021
  • In: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 12:September 2021
  • Journal article (peer-reviewed)abstract
    • Background: Mycophenolic acid (MPA) is a potent immunosuppressive agent used in solid organ transplantation. MPA exhibits large interindividual variation in dose-normalized plasma concentrations but is nevertheless usually prescribed as a fixed dose without use of therapeutic drug monitoring (TDM). Data on the effect of corticosteroid (CS) treatment on MPA concentrations during concomitant tacrolimus treatment remains sparse. Methods: Data is based on TDM of MPA area under the concentration curve (AUC) in 210 renal transplant recipients participating in the prospective, randomized, controlled, multi-center trial (SAILOR) where a steroid-free immunosuppressive regimen with mycophenolate mofetil (MMF) and low-dose tacrolimus was compared with a conventional prednisolone-based treatment regimen. Multilevel mixed-effects linear regression post-hoc analyses of MPA AUC was performed. Results: Median MPA AUC at baseline (within the first 2 weeks post-transplant) in patients taking 2 g MMF daily was 53 mg*h/L (interquartile range: 43–69 mg*h/L, min: 24—max: 117 mg*h/L). Between-patient variation in MPA AUC was up to 5-fold on the same MMF dose. Patients in the steroid-free group had 12.5% lower (95% CI; 3.2–20.9%, p = 0.01) MPA AUC levels at baseline compared to the steroid treated group. During follow-up (14 days–2 years post-transplant) there were no significant differences in MPA AUC between the groups with MPA AUC being 4.2% lower (95% CI: −4.8%−12,5%, p = 0.35) in the steroid-free vs standard treatment group in restricted analysis after multivariate adjustment for tacrolimus trough level, body weight, time after transplantation and MMF dose. MMF dose was positively correlated with MPA AUC (p < 0.001) whereas body weight was negatively correlated with MPA AUC (p < 0.001). MPA AUC was 0.4% (95% CI: 0.2–0.6%, p < 0.001) lower per 1 kg increase in weight. Tacrolimus trough levels had no significant effect on MPA AUC. Conclusion: Immunosuppression with CS during concomitant tacrolimus treatment was shortly after transplantation associated with a significantly higher MPA exposure but the effect was small and not maintained during follow-up. Low body weight was associated with higher MPA exposure, which suggests a potential for weight adjusted MMF dosing.
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30.
  • Olofsson Bagge, Roger, et al. (author)
  • Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases : A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial)
  • 2023
  • In: Journal of Clinical Oncology. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 41:16, s. 3042-3050
  • Journal article (peer-reviewed)abstract
    • PURPOSE: About half of patients with metastatic uveal melanoma present with isolated liver metastasis, in whom the median survival is 6-12 months. The few systemic treatment options available only moderately prolong survival. Isolated hepatic perfusion (IHP) with melphalan is a regional treatment option, but prospective efficacy and safety data are lacking.METHODS: In this multicenter, randomized, open-label, phase III trial, patients with previously untreated isolated liver metastases from uveal melanoma were randomly assigned to receive a one-time treatment with IHP with melphalan or best alternative care (control group). The primary end point was overall survival at 24 months. Here, we report the secondary outcomes of response according to RECIST 1.1 criteria, progression-free survival (PFS), hepatic PFS (hPFS), and safety.RESULTS: Ninety-three patients were randomly assigned, and 87 patients were assigned to either IHP (n = 43) or a control group receiving the investigator's choice of treatment (n = 44). In the control group, 49% received chemotherapy, 39% immune checkpoint inhibitors, and 9% locoregional treatment other than IHP. In an intention-to-treat analysis, the overall response rates (ORRs) were 40% versus 4.5% in the IHP and control groups, respectively (P < .0001). The median PFS was 7.4 months versus 3.3 months (P < .0001), with a hazard ratio of 0.21 (95% CI, 0.12 to 0.36), and the median hPFS was 9.1 months versus 3.3 months (P < .0001), both favoring the IHP arm. There were 11 treatment-related serious adverse events in the IHP group compared with seven in the control group. There was one treatment-related death in the IHP group.CONCLUSION: IHP treatment resulted in superior ORR, hPFS, and PFS compared with best alternative care in previously untreated patients with isolated liver metastases from primary uveal melanoma.
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31.
  • Olofsson Bagge, Roger, 1978, et al. (author)
  • Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial)
  • 2023
  • In: Journal of Clinical Oncology. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 41:16, s. 3042-50
  • Journal article (peer-reviewed)abstract
    • PURPOSEAbout half of patients with metastatic uveal melanoma present with isolated liver metastasis, in whom the median survival is 6-12 months. The few systemic treatment options available only moderately prolong survival. Isolated hepatic perfusion (IHP) with melphalan is a regional treatment option, but prospective efficacy and safety data are lacking.METHODSIn this multicenter, randomized, open-label, phase III trial, patients with previously untreated isolated liver metastases from uveal melanoma were randomly assigned to receive a one-time treatment with IHP with melphalan or best alternative care (control group). The primary end point was overall survival at 24 months. Here, we report the secondary outcomes of response according to RECIST 1.1 criteria, progression-free survival (PFS), hepatic PFS (hPFS), and safety.RESULTSNinety-three patients were randomly assigned, and 87 patients were assigned to either IHP (n = 43) or a control group receiving the investigator's choice of treatment (n = 44). In the control group, 49% received chemotherapy, 39% immune checkpoint inhibitors, and 9% locoregional treatment other than IHP. In an intention-to-treat analysis, the overall response rates (ORRs) were 40% versus 4.5% in the IHP and control groups, respectively (P < .0001). The median PFS was 7.4 months versus 3.3 months (P < .0001), with a hazard ratio of 0.21 (95% CI, 0.12 to 0.36), and the median hPFS was 9.1 months versus 3.3 months (P < .0001), both favoring the IHP arm. There were 11 treatment-related serious adverse events in the IHP group compared with seven in the control group. There was one treatment-related death in the IHP group.CONCLUSIONIHP treatment resulted in superior ORR, hPFS, and PFS compared with best alternative care in previously untreated patients with isolated liver metastases from primary uveal melanoma.
  •  
32.
  • Reivell, Veronica, et al. (author)
  • SOULMATE: the Swedish study of liver transplantation for isolated colorectal cancer liver metastases not suitable for operation or ablation, compared to best established treatment-a randomized controlled multicenter trial
  • 2022
  • In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 23:1
  • Journal article (peer-reviewed)abstract
    • Background: Around one fourth of patients with colorectal cancer present themselves with distant metastases at the time of diagnosis, and one additional one fifth of the patients will develop distant metastases during the disease, most commonly in the liver. Surgical treatment such as liver resection or ablation, often combined with chemotherapy and targeted therapy, is the only treatment option with curative potential, but only about 20% of the patients with liver metastases are candidates for surgical intervention. Standard treatment for unresectable patients is palliative oncological therapy; however, less than 10% of these patients will achieve a 5-year survival. Non-randomized studies indicate that liver transplantation could be an option for selected patients with colorectal liver metastases (CRLM), which are not suitable for operation or ablation due to surgical technical reasons such as massive tumor burden and small future liver remnant, or oncological reasons, for example, early relapse after liver surgery. Since there is a shortage of donated liver grafts, it is important to select the patient group that benefit most from the treatment. Although some studies present positive results from liver transplantation of CRLM, the results must be validated in a randomized controlled trial before this new indication for liver transplantation can be introduced as a clinical routine. Methods: The SOULMATE study is a randomized study evaluating if liver transplantation with liver grafts, primarily from extended criteria donors, increases overall survival in patients with CRLM, not suitable for resection or ablation, in comparison with best established treatment. Patients will be randomized to liver transplantation (LT)+ best established treatment (BET) or to best established treatment only. In the SOULMATE trial, we will evaluate the use of livers from extended criteria donors to decrease the risk of prolonging waiting time for patients on the waiting list for LT. Discussion: The SOULMATE study has the possibility to confirm the positive results of previous studies in a randomized setting. The use of extended criteria donors will make the results transferable globally, as most countries are struggling with organ shortage.
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33.
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34.
  • Romero, Danilo, et al. (author)
  • Self-guided digital intervention to increase post-detoxification treatment-seeking among individuals with substance use disorders : Research protocol with preliminary findings
  • 2023
  • In: Abstracts from the 12th Swedish Congress on internet interventions (SWEsrii), Uppsala University, Sweden. ; , s. 1-2
  • Conference paper (other academic/artistic)abstract
    • Introduction: Inpatient detoxification provides a safe environment for withdrawal from alcohol and/or other drugs, as a possibly vital step towards behavior change. However, many patients relapse soon after discharge from detoxification treatment and readmission is common. Estimates from the US indicate that only every sixth patient seeks and accesses post-detoxification treatment of substance use disorders (SUD). In this two-phase project, we aim to (1) investigate the post-detoxification treatment gap and related patient-reported factors, and (2) develop and evaluate a self-guided digital intervention delivered after discharge, with the aim of increasing post-detoxification treatment.Methods: We have collected data for a registry-based mapping of patient flow from inpatient detoxification to outpatient treatment (N = 9,771) and conducted qualitative interviews (n = 23) on patients’ perceptions of barriers to treatment. These preparatory studies inform the ongoing development of a digital intervention, to be evaluated using a quasi-experimental interrupted time series design. We have conducted a simulation-based power analysis to estimate the minimum detectable effect size.Preliminary results: In addition to general person-related (e.g. stigma) and treatment-related (e.g. low accessibility) barriers to SUD treatment, interviewees reported context-specific barriers, most notably psychological vulnerability following discharge, which for some triggered a reluctance to experience in-person contact. Digital support may thus respond to their needs. In the simulation-based power analysis, we ran 10,000 simulations for each of a total of 128 scenarios, varying intervention length, effect size and change curve. Results suggested that the study, given a 1-year intervention period, an alpha level of .05 and power level of .8, will be powered to detect an absolute increase of at least 2% or 3%.Discussion: To our knowledge, this is the first project to evaluate a digital intervention for promoting post-detoxification treatment seeking. By offering a cost-effective, scalable intervention with minimal exclusion criteria, the study will, in case of successful outcomes, provide a novel and sustainable approach to increase post-detoxification treatment- seeking in real-world settings.
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35.
  • Sedigh, Amir, et al. (author)
  • Heparin Conjugate Pretreatment of Kidneys From Deceased Donors Before Transplantation : Results From the First-in-human Randomized Phase I Trial
  • 2023
  • In: Transplantation direct. - : Wolters Kluwer. - 2373-8731. ; 9:1
  • Journal article (peer-reviewed)abstract
    • Background. Pretreating porcine kidneys with corline heparin conjugate (CHC) during hypothermic machine perfusion (HMP) has been shown to reduce preservation injury and improve early kidney function. In this first-in-human phase I study, the safety and tolerability of transplanting CHC-pretreated kidneys was evaluated.Methods. CHC or placebo was added to the preservation solution during HMP of donated kidneys from deceased donors for at least 3 h before transplantation into adult patients. The primary safety endpoint was the number and severity of adverse events (AEs) and serious AEs (SAEs) during the first 30 d after transplantation.Results. In the first 30 d, 66 AEs were reported in 8 patients who received CHC-pretreated kidneys with 39 AEs in 8 patients who received placebo-pretreated kidneys (P = 0.1 in post hoc analysis). The most common AEs were hypertension (CHC, n = 5; placebo, n = 2) and anemia (CHC, n = 5; placebo, n = 2). Most AEs were assessed as mild (58%) or moderate (39%) and not related to treatment (95%). There were 2 SAEs reported in each group. One SAE, considered possibly related to CHC treatment, was a case of severe postprocedural hemorrhage that required reoperation. No patients needed dialysis. There were no observed rejections and no patient deaths.Conclusions. Pretreatment of kidneys with CHC before transplantation was considered safe and tolerable. Efficacy studies are now planned to investigate if CHC can reduce early ischemia-reperfusion injury in humans.
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36.
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37.
  • Streichart, Lillian, et al. (author)
  • Tocilizumab in chronic active antibody-mediated rejection : rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)
  • 2024
  • In: Trials. - : BioMed Central (BMC). - 1745-6215. ; 25
  • Journal article (peer-reviewed)abstract
    • Background: Chronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remains a challenge to date. Recently, tocilizumab, a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor, has shown promise in the treatment of caAMR. However, it has not been systematically investigated so far underscoring the need for randomized controlled studies in this area.Methods: The INTERCEPT study is an investigator-driven randomized controlled open-label multi-center trial in kidney transplant recipients to assess the efficacy of tocilizumab in the treatment of biopsy-proven caAMR. A total of 50 recipients with biopsy-proven caAMR at least 12 months after transplantation will be randomized to receive either tocilizumab (n = 25) added to our standard of care (SOC) maintenance treatment or SOC alone (n = 25) for a period of 24 months. Patients will be followed for an additional 12 months after cessation of study medication. After the inclusion biopsies at baseline, protocol kidney graft biopsies will be performed at 12 and 24 months. The sample size calculation assumed a difference of 5 ml/year in slope of estimated glomerular filtration rate (eGFR) between the two groups for 80% power at an alpha of 0.05.The primary endpoint is the slope of eGFR at 24 months after start of treatment. The secondary endpoints include assessment of the following at 12, 24, and 36 months: composite risk score iBox, safety, evolution and characteristics of donor-specific antibodies (DSA), graft histology, proteinuria, kidney function assessed by measured GFR (mGFR), patient- and death-censored graft survival, and patient-reported outcomes that include transplant-specific well-being, adherence to immunosuppressive medications and perceived threat of the risk of graft rejection.Discussion: No effective treatment exists for caAMR at present. Based on the hypothesis that inhibition of IL-6 receptor by tocilizumab will reduce antibody production and reduce antibody-mediated damage, our randomized trial has a potential to provide evidence for a novel treatment strategy for caAMR, therewith slowing the decline in graft function in the long-term.
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38.
  • Streichart, Lillian, 1983, et al. (author)
  • Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)
  • 2024
  • In: TRIALS. - : BioMed Central (BMC). - 1745-6215. ; 25:1
  • Journal article (peer-reviewed)abstract
    • BackgroundChronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remains a challenge to date. Recently, tocilizumab, a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor, has shown promise in the treatment of caAMR. However, it has not been systematically investigated so far underscoring the need for randomized controlled studies in this area.MethodsThe INTERCEPT study is an investigator-driven randomized controlled open-label multi-center trial in kidney transplant recipients to assess the efficacy of tocilizumab in the treatment of biopsy-proven caAMR. A total of 50 recipients with biopsy-proven caAMR at least 12 months after transplantation will be randomized to receive either tocilizumab (n = 25) added to our standard of care (SOC) maintenance treatment or SOC alone (n = 25) for a period of 24 months. Patients will be followed for an additional 12 months after cessation of study medication. After the inclusion biopsies at baseline, protocol kidney graft biopsies will be performed at 12 and 24 months. The sample size calculation assumed a difference of 5 ml/year in slope of estimated glomerular filtration rate (eGFR) between the two groups for 80% power at an alpha of 0.05.The primary endpoint is the slope of eGFR at 24 months after start of treatment. The secondary endpoints include assessment of the following at 12, 24, and 36 months: composite risk score iBox, safety, evolution and characteristics of donor-specific antibodies (DSA), graft histology, proteinuria, kidney function assessed by measured GFR (mGFR), patient- and death-censored graft survival, and patient-reported outcomes that include transplant-specific well-being, adherence to immunosuppressive medications and perceived threat of the risk of graft rejection.MethodsThe INTERCEPT study is an investigator-driven randomized controlled open-label multi-center trial in kidney transplant recipients to assess the efficacy of tocilizumab in the treatment of biopsy-proven caAMR. A total of 50 recipients with biopsy-proven caAMR at least 12 months after transplantation will be randomized to receive either tocilizumab (n = 25) added to our standard of care (SOC) maintenance treatment or SOC alone (n = 25) for a period of 24 months. Patients will be followed for an additional 12 months after cessation of study medication. After the inclusion biopsies at baseline, protocol kidney graft biopsies will be performed at 12 and 24 months. The sample size calculation assumed a difference of 5 ml/year in slope of estimated glomerular filtration rate (eGFR) between the two groups for 80% power at an alpha of 0.05.The primary endpoint is the slope of eGFR at 24 months after start of treatment. The secondary endpoints include assessment of the following at 12, 24, and 36 months: composite risk score iBox, safety, evolution and characteristics of donor-specific antibodies (DSA), graft histology, proteinuria, kidney function assessed by measured GFR (mGFR), patient- and death-censored graft survival, and patient-reported outcomes that include transplant-specific well-being, adherence to immunosuppressive medications and perceived threat of the risk of graft rejection.DiscussionNo effective treatment exists for caAMR at present. Based on the hypothesis that inhibition of IL-6 receptor by tocilizumab will reduce antibody production and reduce antibody-mediated damage, our randomized trial has a potential to provide evidence for a novel treatment strategy for caAMR, therewith slowing the decline in graft function in the long-term.
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39.
  • Sunnhed, Rikard, 1979-, et al. (author)
  • Mediators of Cognitive Therapy and Behavior Therapy for Insomnia Disorder : A Test of the Processes in the Cognitive Model
  • 2022
  • In: Journal of Consulting and Clinical Psychology. - : American Psychological Association (APA). - 0022-006X .- 1939-2117. ; 90:9, s. 696-708
  • Journal article (peer-reviewed)abstract
    • Objective: To examine if the processes in the cognitive model mediate cognitive therapy (CT) and behavior therapy (BT) for insomnia. Method: Individuals diagnosed with insomnia disorder (n = 219) were randomized to telephone-supported internet-delivered CT (n = 72), BT (n = 73), or a wait-list (WL; n = 74). Cognitive processes (worry, dysfunctional beliefs, monitoring, and safety behaviors) proposed to maintain insomnia and treatment outcome (insomnia severity index) were assessed biweekly. Criteria for evaluating mediators were assessed via parallel process growth modeling and cross-lagged panel models. Results: Parallel process growth modeling showed that dysfunctional beliefs, monitoring, and safety behaviors significantly mediated the effects of both CT and BT. Cross-lagged panel models confirmed that dysfunctional beliefs and monitoring (approaching significance) influenced subsequent within-individual change in insomnia severity in CT. In BT, however, prior changes in insomnia severity predicted subsequent changes in worry and monitoring, and reciprocal influences among processes and outcomes were observed for dysfunctional beliefs and safety behaviors. Furthermore, the effect of safety behaviors on outcome was significantly larger for BT compared to CT. Conclusion: Together, the findings support the role of dysfunctional beliefs and monitoring as processes of change in CT and safety behaviors as a specific mediator in BT. Limited evidence was provided for worry as a mediator. The findings could improve clinical management and increase our conceptual understanding of insomnia and its maintaining factors by underscoring the relevance of these three processes for insomnia, as well as indicate important routes for future research, such as investigating how baseline presentations might moderate these mediations, for example moderated mediation.
  •  
40.
  • Söfteland, John M., 1977, et al. (author)
  • COVID-19 in solid organ transplant recipients : A national cohort study from Sweden
  • 2021
  • In: American Journal of Transplantation. - : John Wiley & Sons. - 1600-6135 .- 1600-6143. ; 21:8, s. 2762-2773
  • Journal article (peer-reviewed)abstract
    • Solid organ transplant (SOT) recipients run a high risk for adverse outcomes from COVID-19, with reported mortality around 19%. We retrospectively reviewed all known Swedish SOT recipients with RT-PCR confirmed COVID-19 between March 1 and November 20, 2020 and analyzed patient characteristics, management, and outcome. We identified 230 patients with a median age of 54.0 years (13.2), who were predominantly male (64%). Most patients were hospitalized (64%), but 36% remained outpatients. Age >50 and male sex were among predictors of transition from outpatient to inpatient status. National early warning Score 2 (NEWS2) at presentation was higher in non-survivors. Thirty-day all-cause mortality was 9.6% (15.0% for inpatients), increased with age and BMI, and was higher in men. Renal function decreased during COVID-19 but recovered in most patients. SARS-CoV-2 antibodies were identified in 78% of patients at 1-2 months post-infection. Nucleocapsid-specific antibodies decreased to 38% after 6-7 months, while spike-specific antibody responses were more durable. Seroprevalence in 559 asymptomatic patients was 1.4%. Many patients can be managed on an outpatient basis aided by risk stratification with age, sex, and NEWS2 score. Factors associated with adverse outcomes include older age, male sex, greater BMI, and a higher NEWS2 score.
  •  
41.
  • Weinreich, Ilse Duus, et al. (author)
  • Scandiatransplant Exchange Program (STEP) : Development and Results From an International Kidney Exchange Program
  • 2023
  • In: Transplantation direct. - : Lippincott Williams & Wilkins. - 2373-8731. ; 9:11
  • Journal article (peer-reviewed)abstract
    • Background. Kidney transplant candidates may be incompatible with their intended living donors because of the presence of antibodies against HLA and/or ABO. To increase the possibility of finding an acceptable kidney donor for these patients, the Scandiatransplant Exchange Program (STEP) program within Scandiatransplant was launched in 2019.Methods. This is a retrospective review of our experiences from the first 4 y of the STEP program, including details about the match runs, performed transplantations, and recipient outcomes within the program.Results. During 2019-2022, 11 match runs and 4 reruns were performed. In total, 114 pairs and 6 anonymous donors participated in these match runs. Fifty-one pairs (45%) participated in 1 match run, 31 pairs (27%) participated in 2 match runs, and 32 pairs (29%) participated in >= 3 match runs. Seventy-two individuals (63%) participated because of HLA incompatibility, 19 (17%) because of ABO incompatibility, and 7 (6%) because of both HLA and ABO incompatibility. Forty percent of the patients enrolled in the program underwent transplantation. In total, 49 transplantations have so far been performed within the program, and 46 (94%) of the recipients had a functioning kidney graft at follow-up in February 2023.Results. During 2019-2022, 11 match runs and 4 reruns were performed. In total, 114 pairs and 6 anonymous donors participated in these match runs. Fifty-one pairs (45%) participated in 1 match run, 31 pairs (27%) participated in 2 match runs, and 32 pairs (29%) participated in >= 3 match runs. Seventy-two individuals (63%) participated because of HLA incompatibility, 19 (17%) because of ABO incompatibility, and 7 (6%) because of both HLA and ABO incompatibility. Forty percent of the patients enrolled in the program underwent transplantation. In total, 49 transplantations have so far been performed within the program, and 46 (94%) of the recipients had a functioning kidney graft at follow-up in February 2023.Conclusions. The STEP program offers sensitized patients an enlarged pool of living donors and a chance of a compatible international living donor, resulting in an increased number of total transplantations. Currently, STEP is one of the largest transnational kidney exchange programs and has improved the situation for patients waiting for kidney transplantation in Scandiatransplant.
  •  
42.
  • Weinreich, I. D., et al. (author)
  • Scandiatransplant Exchange Program (STEP): Development and Results From an International Kidney Exchange Program
  • 2023
  • In: Transplantation Direct. - 2373-8731. ; 9:11
  • Journal article (peer-reviewed)abstract
    • Background. Kidney transplant candidates may be incompatible with their intended living donors because of the presence of antibodies against HLA and/or ABO. To increase the possibility of finding an acceptable kidney donor for these patients, the Scandiatransplant Exchange Program (STEP) program within Scandiatransplant was launched in 2019.Methods. This is a retrospective review of our experiences from the first 4 y of the STEP program, including details about the match runs, performed transplantations, and recipient outcomes within the program.Results. During 2019-2022, 11 match runs and 4 reruns were performed. In total, 114 pairs and 6 anonymous donors participated in these match runs. Fifty-one pairs (45%) participated in 1 match run, 31 pairs (27%) participated in 2 match runs, and 32 pairs (29%) participated in >= 3 match runs. Seventy-two individuals (63%) participated because of HLA incompatibility, 19 (17%) because of ABO incompatibility, and 7 (6%) because of both HLA and ABO incompatibility. Forty percent of the patients enrolled in the program underwent transplantation. In total, 49 transplantations have so far been performed within the program, and 46 (94%) of the recipients had a functioning kidney graft at follow-up in February 2023.Results. During 2019-2022, 11 match runs and 4 reruns were performed. In total, 114 pairs and 6 anonymous donors participated in these match runs. Fifty-one pairs (45%) participated in 1 match run, 31 pairs (27%) participated in 2 match runs, and 32 pairs (29%) participated in >= 3 match runs. Seventy-two individuals (63%) participated because of HLA incompatibility, 19 (17%) because of ABO incompatibility, and 7 (6%) because of both HLA and ABO incompatibility. Forty percent of the patients enrolled in the program underwent transplantation. In total, 49 transplantations have so far been performed within the program, and 46 (94%) of the recipients had a functioning kidney graft at follow-up in February 2023.Conclusions. The STEP program offers sensitized patients an enlarged pool of living donors and a chance of a compatible international living donor, resulting in an increased number of total transplantations. Currently, STEP is one of the largest transnational kidney exchange programs and has improved the situation for patients waiting for kidney transplantation in Scandiatransplant.
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