Search

Tanja Sofie Hansen,1,2 Ingrid Poulsen,2– 4 Vibeke Nørholm,3 Mia Ingerslev Loft,4,5 Pia Søe Jensen3,4,6 1Department of Medical Diseases, Amager Hvidovre Copenhagen University Hospital, Copenhagen, Denmark; 2Department of Public Health, Section of Nursing, Aarhus University, Aarhus, Denmark; 3Department of Clinical Research, Hvidovre Copenhagen University Hospital, Copenhagen, Denmark; 4Institute for People and Technology, Roskilde University, Roskilde, Denmark; 5Department of Neurology, Rigshospitalet, Copenhagen, Denmark; 6Department of Orthopaedic Surgery, Hvidovre Copenhagen University Hospital, Copenhagen, DenmarkCorrespondence: Tanja Sofie Hansen, Amager Hvidovre Copenhagen University Hospital, Kettegaard Allé 30, Hvidovre, 2650, Denmark, Tel +45 30 48 89 30, Email tanja.sofie.hansen@regionh.dkBackground: The knowledge is sparse in the literature on intervention programs using nutritional support and physical activity for patients with chronic obstructive pulmonary disease within a person-centred approach. We aimed to explore and map the existing evidence on intervention programs with a person-centred approach, focusing on nutritional support and physical activity for people with COPD.Methods: A scoping review was conducted using Arksey & O’Malley’s methodological framework. A search in the databases CINAHL and PubMed, and a grey literature search, was conducted in June 2022 and updated in June 2023. We identified studies published between 2012 and 2023. The PRISMA checklist for scoping reviews, supported by The PAGER framework was used for reporting the method.Results: A total of 15 studies were included. The primary interventions comprised behavior of change or self-management, addressing needs assessment, motivation, personal goals, education, and physical activity. Health-related quality of life and hospital stay displayed no clinically significant variances. However, eight studies demonstrated differences in physical function and activity levels. Nutritional outcomes were addressed in one study, and three studies involved relatives.Conclusion: This scoping review addresses a knowledge gap in nutritional support interventions with a person-centred approach. It indicates that there is a need to increase nutritional support and consider the patient’s physical and social environmental resources within Behavior of change or Self-management intervention programs for patients with COPD. The review found no clinical effect on health-related quality of life, although there were some effects on physical activity. The results highlight how the interdisciplinary team can include the patients’ resources when structuring the management of COPD by applying a person-centred approach.Keywords: COPD, pulmonary rehabilitation, self-management program, motivational techniques

Michael Cronquist Christensen,1 Francesca Canellas,2,3 Henrik Loft,1 Ángel L Montejo4– 6 1H. Lundbeck A/S, Valby, Denmark; 2Psychiatric Department, Son Espases University Hospital, Palma de Mallorca, Spain; 3Health Research Institute of the Balearic Islands (IdISBa), Palma de Mallorca, Spain; 4Institute of Biomedicine of Salamanca (IBSAL), Salamanca, Spain; 5Psychiatric Service, University of Salamanca Health Care Complex, Salamanca, Spain; 6University of Salamanca, Faculty of Nursing, Salamanca, SpainCorrespondence: Michael Cronquist Christensen, H. Lundbeck A/S, Ottiliavej 9, Valby 2500, Denmark, Tel +45 3083 5168, Email MCRC@lundbeck.comBackground: The multinational, open-label COMPLETE study (NCT03835715) investigated the effectiveness of vortioxetine in alleviating emotional blunting in patients with major depressive disorder (MDD) experiencing inadequate response and emotional blunting while being treated with a selective serotonin reuptake inhibitor (SSRI) or serotonin–noradrenaline reuptake inhibitor (SNRI). This paper presents results for the subgroup of patients enrolled in Spain.Methods: Patients with MDD (n = 67) experiencing partial response and emotional blunting during monotherapy with an SSRI or SNRI were switched to vortioxetine (10– 20 mg/day) for 8 weeks. The primary study outcome was emotional blunting, assessed by the Oxford Depression Questionnaire (ODQ).Results: After 8 weeks of vortioxetine, the mean (SE) change in ODQ total score from baseline was − 26.0 (2.9) (P < 0.001). Respective changes in Montgomery–Åsberg Depression Rating Scale (MADRS), Motivation and Energy Inventory, Digit Symbol Substitution Test, and Sheehan Disability Scale (SDS) total scores were − 14.9 (0.8), +34.2 (4.5), +6.3 (1.6), and ‒9.0 (1.3) (all P < 0.001 vs baseline). At week 8, 70.4% of patients no longer reported emotional blunting and 53.7% had achieved remission from their depressive symptoms (defined as a MADRS total score ≤ 10). Mediation analysis showed 77.1% of the change in SDS total score to be a direct effect of the improvement in ODQ total score after switching to vortioxetine. Adverse events were reported by 35 patients (52.2%), most commonly nausea (14 patients, 20.9%). At week 8, 33/54 patients (61.1%) were receiving vortioxetine 20 mg/day.Conclusion: In this study investigating the effectiveness of vortioxetine in Spanish patients with MDD who experienced inadequate response and emotional blunting on SSRI/SNRI monotherapy, significant improvements in emotional blunting, core depressive symptoms (including anhedonia), sleep duration, motivation and energy, cognitive performance, and overall patient functioning were observed during the 8 weeks of treatment. Two-thirds of patients no longer reported emotional blunting and over half were in remission from their depressive symptoms at week 8.Keywords: emotional blunting, energy, major depressive disorder, motivation, patient functioning, vortioxetine

Roger S McIntyre,1 Henrik Loft,2 Michael Cronquist Christensen3 1Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada; 2Department of Biostatistics and Programming, H. Lundbeck A/S, Valby, Denmark; 3Department of Psychiatry Products, H. Lundbeck A/S, Valby, DenmarkCorrespondence: Michael Cronquist ChristensenH. Lundbeck A/S, Ottiliavej 9, 2500 Valby, DenmarkTel +45 30835168Email MCRC@lundbeck.comPurpose: Anhedonia is a core symptom of major depressive disorder (MDD), which has important functional consequences for the patient. This post hoc analysis investigated the relationship between anhedonia and functioning in patients with MDD treated with vortioxetine.Patients and Methods: We conducted a pooled analysis of all 11 short-term, double-blind, randomized, placebo-controlled studies of vortioxetine (fixed dose, 5– 20 mg/day) in patients with MDD which included Montgomery–Åsberg Depression Rating Scale (MADRS) and Sheehan Disability Scale (SDS) assessments. A short-term, randomized, active-controlled trial of flexible-dose treatment with vortioxetine (10– 20 mg/day) versus agomelatine (25– 50 mg/day) was also analyzed. Mean changes from baseline to study endpoint in MADRS total, MADRS anhedonia subscale, SDS total, and SDS social-functioning scores were analyzed by a mixed model for repeated measures. The relationship between treatment effects on anhedonia and functioning was investigated using path analysis.Results: A total of 4988 patients with MDD were included in the placebo-controlled studies and 495 in the active-comparator study. Significant dose-dependent improvements in overall depressive symptoms, anhedonia, and measures of functioning were seen in vortioxetine-treated patients compared with those who received placebo or agomelatine. Results of the path analysis for the placebo-controlled studies suggested that the effect on functioning was mostly driven by the effect of treatment on MADRS anhedonia factors.Conclusion: Vortioxetine showed significant short-term efficacy against anhedonia in this large population of patients with MDD. In the placebo-controlled studies, improvements in functioning associated with vortioxetine appeared to be mostly driven by the effect of treatment on MADRS anhedonia factors.Keywords: anhedonia, functioning, major depressive disorder, vortioxetine

Else Helene Ibfelt,1 Jan Sørensen,2,3 Dorte V Jensen,4,5 Lene Dreyer,5,6 Berit Schiøttz‑Christensen,7 Pia H Thygesen,8 Ada Colic,9 Johnny L Raun,10 Natalia Manilo,11 Anne Rødgaard,4 Uta E Poulsen,12 Claus Rasmussen,13 Torben Hansen,14 Babara Unger,15 Randi Pelck,16 Anita Kincses,17 Henrik Nordin,18 Tove Lorenzen,19 Ali Theibich,20 Inger Marie Jensen Hansen,21 Jakob Espesen,22 Jolanta Grydehøj,23 Mette Holland-Fischer,24 Anne Gitte Loft,25 Merete Lund Hetland4,26 1Research Centre for Prevention and Health, Capital Region of Denmark, Rigshospitalet – Glostrup, Denmark; 2Centre of Health Economics Research, Institute of Public health, University of Southern Denmark, Odense, Denmark; 3Healthcare Outcome Research Centre, Royal College of Surgeons in Ireland, Dublin, Ireland; 4DANBiO and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet – Glostrup, Glostrup, 5Center for Rheumatology and Spine Diseases, Gentofte University Hospital, Hellerup, 6The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, 7Spine Centre of Southern Denmark, Hospital Lillebaelt, Middelfart, 8Department of Rheumatology, Odense University Hospital, Odense, 9Department of Rheumatology, Sydvestjysk Sygehus, Esbjerg/Grintsted, 10Department of Internal Medicine and Rheumatology, SLB – Fredericia Hospital, Fredericia, 11Department of Rheumatology, Frederiksberg Hospital, Copenhagen, 12Department of Rheumatology, Gigthospital Gråsten, Gråsten, 13Clinic of Internal Medicine, Rheumatology, Regionshospital Nordjylland, Hjørring, 14Department of Rheumatology, Holbæk sygehus, Holbæk, 15Department of Internal Medicine/Rheumatology, Hospitalsenheden Horsens, Horsens, 16Department of Rheumatology, Zealand University Hospital, Køge, 17Department of Rheumatology, Nordsjællands Hospitaler, Hillerød, 18Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, 19Department of Rheumatology, Silkeborg Regional Hospital and University Clinic, Silkeborg, 20Department of Rheumatology, Slagelse Hospital, Slagelse, 21Department of Rheumatology and University of Southern Denmark, Svendborg Hospital, Odense, 22Department of Internal Medicine, Vejle Hospital, Vejle, 23Department of Rheumatology, Regional Hospital, West Jutland, Herning, 24Department of Rheumatology, Aalborg University Hospital, Ålborg, 25Department of Rheumatology, Aarhus University Hospital, Aarhus, 26Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Objectives: In Denmark, patients with rheumatoid arthritis (RA) are registered in the nationwide clinical DANBIO quality register and the Danish National Patient Registry (DNPR). The aim was to study the validity of the RA diagnosis and to estimate the completeness of relevant RA cases in each registry.Study design and setting: Patients registered for the first time in 2011 with a diagnosis of RA were identified in DANBIO and DNPR in January 2013. For DNPR, filters were applied to reduce false-positive cases. The diagnosis was verified by a review of patient records. We calculated the positive predictive values (PPVs) of the RA diagnosis registrations in DANBIO and DNPR, and estimated the registry completeness of relevant RA cases for both DANBIO and DNPR. Updated data from 2011 to 2015 from DANBIO were retrieved to identify patients with delayed registration, and the registry completeness and PPV was recalculated.Results: We identified 1,678 unique patients in DANBIO or in DNPR. The PPV (2013 dataset) was 92% in DANBIO and 79% in DNPR. PPV for DANBIO on the 2015 update was 96%. The registry completeness of relevant RA cases was 43% in DANBIO, increasing to 91% in the 2015 update and 90% in DNPR.Conclusion: DANBIO held a high proportion of true RA cases (96%) and was found to be superior to the DNPR (79%) with regard to the validity of the diagnosis. Both registries were estimated to have a high completeness of RA cases treated in hospital care (~90%). Keywords: rheumatoid arthritis, validity, incidence, clinical registry, Denmark

Delphine Saragoussi,1 Maëlys Touya,2 Josep Maria Haro,3 Bengt Jönsson,4 Martin Knapp,5 Bastien Botrel,6 Ioana Florea,7 Henrik Loft,8 Benoît Rive9 1Real-World Evidence and Epidemiology, Lundbeck SAS, Issy-les-Moulineaux, France; 2Health Economics and Outcomes Research, Lundbeck, Deerfield, IL, US; 3Research and Teaching Unit, Parc Sanitari Sant Joan de Deu, CIBERSAM, University of Barcelona, Sant Boi de Llobregat, Barcelona, Spain; 4Department of Economics, Stockholm School of Economics, Stockholm, Sweden; 5Department of Health Policy, London School of Economics and Political Science, London, UK; 6Biostatistics, Inferential, Paris, France; 7Clinical Research Paediatrics, H. Lundbeck A/S, Valby, Denmark; 8Biometrics, H. Lundbeck A/S, Valby, Denmark; 9Global Analytics, Lundbeck SAS, Issy-les-Moulineaux, France Background: The Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder (PERFORM) study has been initiated to better understand the course of a depressive episode and its impact on patient functioning. This analysis aimed to identify sociodemographic and clinical factors associated with failure to achieve remission at month 2 after initiating or switching antidepressant monotherapy and with subsequent relapse at month 6 for patients in remission at month 2. Materials and methods: This was a 2-year observational cohort study in 1,159 outpatients aged 18–65 years with major depressive disorder initiating or undergoing the first switch of antidepressant monotherapy. Factors with P8 weeks (OR 0.51), being in psychotherapy (OR 0.51), sexual dysfunction (OR 0.62), and severity of depression (OR 0.87). Factors significantly associated with relapse at month 6 were male sex (OR 2.47), being married or living as a couple (OR 2.73), residual patient-reported cognitive symptoms at 2 months (OR 1.12 per additional unit of Perceived Deficit Questionnaire-5 score) and residual depressive symptoms at 2 months (OR 1.27 per additional unit of Patient Health Questionnaire-9 score). Conclusion: Different factors appear to be associated with failure to achieve remission in patients with major depressive disorder and with subsequent relapse in patients who do achieve remission. Patient-reported cognitive dysfunction is an easily measurable and treatable characteristic that may be associated with an increased likelihood of relapse at 6 months in patients who have achieved remission. Keywords: major depressive disorder, remission, relapse, patient-reported cognitive dysfunction

Sub-Saharan Africa is under-represented in global biodiversity datasets, particularly regarding the impact of land use on species population abundances. Drawing on recent advances in expert elicitation to ensure data consistency, 200 experts were convened using a modified-Delphi process to estimate intactness scores: the remaining proportion of an intact reference population of a species group in a particular land use, on a scale from 0 (no remaining individuals) to 1 (same abundance as the reference) and, in rare cases, to 2 (populations that thrive in human-modified landscapes). The resulting bii4africa dataset contains intactness scores representing terrestrial vertebrates (tetrapods: ±5,400 amphibians, reptiles, birds, mammals) and vascular plants (±45,000 forbs, graminoids, trees, shrubs) in sub-Saharan Africa across the regions major land uses (urban, cropland, rangeland, plantation, protected, etc.) and intensities (e.g., large-scale vs smallholder cropland). This dataset was co-produced as part of the Biodiversity Intactness Index for Africa Project. Additional uses include assessing ecosystem condition; rectifying geographic/taxonomic biases in global biodiversity indicators and maps; and informing the Red List of Ecosystems.

Increased automation transparency can improve the accuracy of automation use but can lead to increased bias towards agreeing with advice. Information about the automation's confidence in its advice may also increase the predictability of automation errors. We examined the effects of providing automation transparency, automation confidence information, and their potential interacting effect on the accuracy of automation use and other outcomes. An uninhabited vehicle (UV) management task was completed where participants selected the optimal UV to complete missions. Low or high automation transparency was provided, and participants agreed/disagreed with automated advice on each mission. We manipulated between participants whether automated advice was accompanied by confidence information. This information indicated on each trial whether automation was "somewhat" or "highly" confident in its advice. Higher transparency improved the accuracy of automation use, led to faster decisions, lower perceived workload, and increased trust and perceived usability. Providing participant automation confidence information, as compared with not, did not have an overall impact on any outcome variable and did not interact with transparency. Despite no benefit, participants who were provided confidence information did use it. For trials where lower compared to higher confidence information was presented, hit rates decreased, correct rejection rates increased, decision times slowed, and perceived workload increased, all suggestive of decreased reliance on automated advice. Such trial-by-trial shifts in automation use bias and other outcomes were not moderated by transparency. These findings can potentially inform the design of automated decision-support systems that are more understandable by humans in order to optimise human-automation interaction.

Prospective memory (PM) tasks require remembering to perform a deferred action and can be associated with predictable contexts. We present a theory and computational model, prospective memory decision control (PMDC), of the cognitive processes by which context supports PM. Under control conditions, participants completed lexical decisions. Under PM conditions, participants had the additional PM task of responding to letter strings containing certain syllables. Stimuli were presented in one of two colors, with color potentially changing after each set of four trials. A pretrial colored fixation was presented before each set. Under control and PM standard conditions, fixation color was meaningless. Under PM context conditions, fixation color indicated whether a PM target could occur within the next set. We replicated prior findings of higher PM accuracy for context compared to standard conditions, and the expected variation in PM costs (slowed lexical decisions) as a function of context relevance. PMDC, which formalizes PM as a process of evidence accumulation among ongoing and PM task responses, accounted for the impact of context on PM costs and accuracy via proactive and reactive cognitive control. Increased ongoing task thresholds and decreased PM thresholds in relevant contexts indicated proactive control. With context provision, PM accumulation rates on PM trials increased, as did inhibition of accumulation to competing responses, indicating reactive control. Although an observed capacity-sharing effect explained some portion of PM costs, we found no evidence that participants redirected more capacity from the ongoing to the PM task when contextually cued to relevant contexts.

In a range of settings, human operators make decisions with the assistance of automation, the reliability of which can vary depending upon context. Currently, the processes by which humans track the level of reliability of automation are unclear. In the current study, we test cognitive models of learning that could potentially explain how humans track automation reliability. We fitted several alternative cognitive models to a series of participants' judgements of automation reliability observed in a maritime classification task in which participants were provided with automated advice. We examined three experiments including eight between-subjects conditions and 240 participants in total. Our results favoured a two-kernel delta-rule model of learning, which specifies that humans learn by prediction error, and respond according to a learning rate that is sensitive to environmental volatility. However, we found substantial heterogeneity in learning processes across participants. These outcomes speak to the learning processes underlying how humans estimate automation reliability and thus have implications for practice.

Mainstreaming of ecosystem service approaches has been proposed as one path toward sustainable development. Meanwhile, critics of ecosystem services question if the approach can account for the multiple values of ecosystems to diverse groups of people, or for aspects of inter- and intra-generational justice. In particular, an ecosystem service approach often overlooks power dimensions and capabilities that are core to environmental justice. This article addresses the need for greater guidance on incorporating justice into ecosystem services research and practice. We point to the importance of deep engagement with stakeholders and rights holders to disentangle contextual factors that moderate justice outcomes on ecosystem service attribution and appropriation in socio-political interventions. Such a holistic perspective enables the integration of values and knowledge plurality for enhancing justice in ecosystem services research. This broadened perspective paves a way for transformative ecosystem service assessments, management, and research, which can help inform and design governance structures that nourish human agency to sustainably identify, manage, and enjoy ecosystem services for human wellbeing.

68Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist associated with high sensitivity and reproducibility in neuroendocrine tumor (NET) detection and localization. However, the optimal peptide mass and radioactivity ranges for 68Ga-satoreotide trizoxetan have not yet been established. We therefore aimed to determine its optimal dosing regimen in patients with metastatic gastroenteropancreatic NETs in a prospective, randomized, 2 × 3 factorial, multicenter phase II study. Methods: Patients received 68Ga-satoreotide trizoxetan at a peptide mass of 5-20 µg on day 1 of the study and of 30-45 µg on days 16-22, at 1 of 3 68Ga radioactivity ranges (40-80, 100-140, or 160-200 MBq). Whole-body PET/CT imaging was performed 50-70 min after each injection. The primary endpoint was the detection rate of NET lesions imaged by 68Ga-satoreotide trizoxetan relative to contrast-enhanced CT (for each of the 6 peptide mass and radioactivity range combinations). Results: Twenty-four patients were evaluated in the per-protocol analysis. The median number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT or PET alone was at least twice as high as the number detected by contrast-enhanced CT across the 6 studied peptide mass and radioactivity range combinations. There were no differences between the 2 peptide mass ranges or between the 3 radioactivity ranges in the number of identified lesions. However, a trend toward a lower relative lesion count was noted in the liver for the 40- to 80-MBq range. No relationship was observed between the radioactivity range per patient's body weight (MBq/kg) and the number of lesions detected by 68Ga-satoreotide trizoxetan. The median diagnostic sensitivity of 68Ga-satoreotide trizoxetan PET/CT, based on the number of lesions per patient, ranged from 85% to 87% across the different peptide mass and radioactivity ranges. Almost all reported adverse events were mild and self-limiting. Conclusion: A radioactivity of 100-200 MBq with a peptide mass of up to 50 µg was confirmed as the optimal dosing regimen for 68Ga-satoreotide trizoxetan to be used in future phase III studies.

Author(s): Michael S. Humphreys [sup.1] , Gerald Tehan [sup.2] , Oliver Baumann [sup.3] , Shayne Loft [sup.4] Author Affiliations: (1) grid.1003.2, 0000 0000 9320 7537, School of Psychology, The University [...], The idea that some recently encountered items reside in a special state where they do not have to be retrieved has come to be a critical component of short-term memory theories. In the current work, the existence of such a special state was tested using the probe-recognition paradigm followed by a delayed recognition test. Across two experiments participants received a series of probe recognition trials where list lengths of 1-, 4- and 8-items were intermixed. Delayed recognition performance for non-target probes was poorer for the only item in 1-item lists than for the last item in multi-item lists. At the same time, the delayed recognition of studied-but-not probed items was better for the 1-item list, compared to the last item in a multi-item list, indicating that some form of a retrieval effect was involved and not lower levels of attention/initial learning. An examination of the size of the testing effect as it varied across list lengths and experiments also indicated that residence in a special state was not playing an important role. Overall, the data are not in support of the assumption that items at the focus of attention are in a special state that do not require retrieval. Our conclusions are that special states cannot be used to define STM memory and that the probe recognition paradigm may be useful in determining how testing affects memory.