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  • 1.
    Bartha, Erzsebet
    et al.
    Karolinska University Hospital, Sweden.
    Davidson, Thomas
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Brodtkorb, Thor-Henrik
    RTI Health Solut, Sweden.
    Carlsson, Per
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Health Sciences.
    Kalman, Sigridur
    Karolinska University Hospital, Sweden.
    Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients2013In: Trials, E-ISSN 1745-6215, Vol. 14Article in journal (Refereed)
    Abstract [en]

    Background

    A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation’s main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed.

    Methods

    A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society’s willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT.

    Results

    If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society’s willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million.

    Conclusions

    If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as ‘further research is needed’ are replaced with ‘further research is cost-effective and ‘further funding of a trial is justified’.

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  • 2.
    Bergman Nordgren, Lise
    et al.
    Linköping University, Department of Behavioural Sciences and Learning. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Clinical and Social Psychology. Linköping University, Faculty of Arts and Sciences.
    Kadowaki, Åsa
    Linköping University, Department of Social and Welfare Studies. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Psychiatry.
    Carlbring, Per
    Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 1, p. 16-Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. METHODS: Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. DISCUSSION: This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial registration: Clinical trials identifier NCT01390168.

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  • 3.
    Bertuzzi, Vanessa
    et al.
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Semonella, Michelle
    Department of Psychology, Bar-Ilan University, 52900, Ramat-Gan, Israel.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Department of Clinical Neuroscience, Karolinska Institute, Solna, Sweden.
    Manzoni, Gian Mauro
    Department of Psychology, Faculty of Psychology, eCampus University, 22100, Como, Italy.
    Castelnuovo, Gianluca
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Molinari, Enrico
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Pietrabissa, Giada
    Department of Psychology, Catholic University of Milan, 20123, Milan, Italy.
    Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project.2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 801Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: This study aims to evaluate the feasibility and effectiveness of the RinasciMENTE program, an Internet-based self-help intervention based on cognitive behavioral therapy (CBT) principles and techniques in supporting individuals experiencing psychological impairments during the COVID-19 pandemic. A randomized controlled trial (RCT) design with random allocation at the level of individual will be conducted to compare the impact of the RinasciMENTE program with a waiting list control in improving the psychological functioning of the general population during the COVID-19 pandemic.

    METHODS: A minimum sample of 128 participants experiencing mild/subthreshold levels of psychological symptoms during the COVID-19 pandemic will be recruited. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 2 months, during which participants will receive 8 weekly CBT treatment modules. The impact of the RinasciMENTE program on selected primary and secondary psychological outcomes will be tested at the end of the intervention (2 months) and 6- and 12-month follow-ups.

    DISCUSSION: We expect people to show an increased level of psychological functioning and to acquire the skills and self-confidence necessary to deal with the psychological consequences of the COVID-19 outbreak and its related social isolation during and following the pandemic.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT0497903 Registered on 28 May 2021.

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  • 4.
    Beukes, Eldre W.
    et al.
    Anglia Ruskin University, England.
    Baguley, David M.
    Anglia Ruskin University, England; Nottingham Biomed Research Centre, England; University of Nottingham, England.
    Allen, Peter M.
    Anglia Ruskin University, England; Anglia Ruskin University, England.
    Manchaiah, Vinaya
    Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research. Lamar University, TX 77710 USA; Audiol India, India; Manipal University, India.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institute, Sweden.
    Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial2017In: Trials, E-ISSN 1745-6215, Vol. 18, article id 186Article in journal (Refereed)
    Abstract [en]

    Background: Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. population. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. Methods/design: This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. Discussion: This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems.

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  • 5.
    Björnsson, Bergthor
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Sandström, Per
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Lindhoff Larsson, Anna
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Hjalmarsson, Claes
    Blekinge Hosp, Sweden; Lund Univ, Sweden.
    Gasslander, Thomas
    Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, article id 356Article in journal (Refereed)
    Abstract [en]

    BackgroundEarlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only one randomized study has been conducted showing reduced time to functional recovery after LDP compared with ODP.MethodsLAPOP is a prospective randomized, nonblinded, parallel-group, single-center superiority trial. Sixty patients with lesions in the pancreatic body or tail that are found by a multidisciplinary tumor board to need surgical resection will be randomized to receive LDP or ODP. The primary outcome variable is postoperative hospital stay, and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids and as the ability of an ambulatory patient to perform activities of daily life), perioperative bleeding, complications, need for pain medication, and quality of life comparison.DiscussionThe LAPOP trial will test the hypothesis that LDP reduces postoperative hospital stay compared with ODP.Trial registrationISRCTN, 26912858. Registered on 28 September 2015.

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  • 6.
    Boettcher, Johanna
    et al.
    Department of Clinical Psychology and Psychotherapy, Freie Universität Berlin, Berlin, Germany.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Department of Psychology, Stockholm University, Sweden.
    Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 1, p. 68-Article in journal (Refereed)
    Abstract [en]

    Background

    Guided Internet-based cognitive-behavioral therapy (ICBT) has been found to be effective for social anxiety disorder (SAD) by several independent research groups. However, since the extent of clinically significant change demonstrated leaves room for improvement, new treatments should be developed and investigated. A novel treatment, which has generally been found to be effective, is cognitive bias modification (CBM). This study aims to evaluate the combination of CBM and ICBT. It is intended that two groups will be compared; one group randomized to receiving ICBT and CBM towards threat cues and one group receiving ICBT and control training. We hypothesize that the group receiving ICBT plus CBM will show superior treatment outcomes.

    Methods/design

    Participants with SAD (N = 128), will be recruited from the general population. A composite score combining the scores obtained from three social anxiety questionnaires will serve as the primary outcome measure. Secondary measures include self-reported depression and quality of life. All treatments and assessments will be conducted via the Internet and measurement points will be baseline, Week 2, post-treatment, and 4 months post-treatment.

    Discussion

    There is no direct evidence of the effects of combining CBM and ICBT in SAD. Adding attention-training sessions to ICBT protocols could increase the proportion of participants who improve and recover through Internet-based self-help.

    Trial registration

    ClinicalTrials.gov:NCT01570400

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  • 7.
    Carlbring, Per
    et al.
    Department of Psychology, Stockholm University, Stockholm, Sweden.
    Lindner, Philip
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden and Department of Psychology, Umeå University, Umeå, Sweden .
    Martell, Christopher
    Martell Behavioral Activation Research Consulting and Department of Psychology, University of Wisconsin, Milwaukee, WI, USA.
    Hassmén, Peter
    Department of Psychology, Umeå University, Umeå, Sweden.
    Forsberg, Lars
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
    Ström, Lars
    Department of Psychology, Umeå University, Umeå, Sweden.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 35Article in journal (Refereed)
    Abstract [en]

    Background

    Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.

    Methods/Design

    This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.

    Discussion

    The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.

    Trial registration

    ClinicalTrials.gov: NCT01619930

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  • 8.
    Chen, C.
    et al.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Ahlqvist, V. H.
    Karolinska Inst, Sweden.
    Henriksson, Pontus
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Hidalgo Migueles, Jairo Hidalgo
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. Univ Granada, Spain.
    Christiansen, F.
    Karolinska Inst, Sweden.
    Galanti, M. R.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Berglind, D.
    Karolinska Inst, Sweden; Ctr Epidemiol & Community Med CES, Sweden.
    Increasing Childrens physical Activity by Policy (CAP) in preschools within the Stockholm region: study protocol for a pragmatic cluster-randomized controlled trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 577Article in journal (Refereed)
    Abstract [en]

    Background: Systematic reviews suggest that preschool environmental/organizational changes may be effective in increasing physical activity (PA) levels of preschool children, but evidence is scarce regarding feasible, effective, and equitable interventions that can be scaled up. Specifically, it is essential to understand whether introducing a multicomponent organizational change in terms of policy in the preschool context may be beneficial for childrens PA levels and concomitant health outcomes. To bridge this knowledge gap, our main aim is to examine the feasibility and effectiveness of a policy package in increasing PA levels in preschool children, using a large-scale pragmatic cluster-randomized controlled trial. Methods: This proposed study is a pragmatic cluster-randomized controlled trial with two conditions (intervention and control with a 1:1 ratio) with preschools as clusters and the unit of randomization. We aim to recruit approximately 4000 3-5-year-old children from 90 preschools and retain more than 2800 children from 85 preschools to provide adequate statistical power for the analyses. The intervention to implement is a co-created, multicomponent policy package running for 6 months in preschools randomized to intervention. Change in accelerometer measured PA levels in children between intervention and control from pre- and post-intervention will be the primary outcome of the study, while secondary outcomes include health outcomes such as musculoskeletal fitness, psychosocial functioning, and absence due to illness in children among others. Implementation will be studied carefully using both quantitative (dose, fidelity) and qualitative (interview) methodologies. The change in primary and secondary outcomes, from pre- to post-intervention, will be analyzed with linear mixed-effect models (to allow both fixed and random effects) nested on a preschool level. Discussion: This is a large-scale co-creation project involving the City of Stockholm, childcare stakeholders, preschool staff, and the research group with the potential to influence more than 30,000 preschool children within the Stockholm area. The study will add reliable evidence for the implementation of PA policies at the organizational level of preschools and clarify its potential effect on objectively measured PA and health markers in children.

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  • 9.
    de Graaf, Nine
    et al.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Emmen, Anouk M. L. H.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Ramera, Marco
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy.
    Björnsson, Bergthor
    Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping. Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology.
    Boggi, Ugo
    Department of Surgery, Universitá Di Pisa, Pisa, Italy.
    Bruna, Caro L.
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, iTALY; Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Busch, Olivier R.
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Daams, Freek
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Ferrari, Giovanni
    Department of Surgery, Niguarda Ca’Granda Hospital, Milan, Italy.
    Festen, Sebastiaan
    Cancer Center Amsterdam, Amsterdam, Netherlands.
    van Hilst, Jony
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, NetherlandsDepartment of Surgery, OLVG, Amsterdam, Netherlands.
    D’Hondt, Mathieu
    Department of Surgery, AZ Groeninge, Kortrijk, Belgium.
    Ielpo, Benedetto
    Department of Surgery, Hospital del Mar, Barcelona, Spain.
    Keck, Tobias
    Department of Surgery, UKSH Campus Lübeck, Lübeck, Germany.
    Khatkov, Igor E.
    Department of Surgery, Moscow Clinical Scientific Center, Moscow, Russian Federation.
    Koerkamp, Bas Groot
    Department of Surgery, Erasmus MC, Rotterdam, Netherlands.
    Lips, Daan J.
    Department of Surgery, Medisch Spectrum Twente, Enschede, Netherlands.
    Luyer, Misha D. P.
    Department of Surgery, Catharina Ziekenhuis, Eindhoven, Netherlands.
    Mieog, J. Sven D.
    Department of Surgery, Leiden University Medical Center, Leiden, Netherlands.
    Morelli, Luca
    General Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
    Molenaar, I. Quintus
    Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands .
    van Santvoort, Hjalmar C.
    Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands; Department of Surgery, St. Antonius Hospital, Nieuwegein, Netherlands .
    Sprangers, Mirjam A. G.
    Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.
    Ferrari, Clarissa
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
    Berkhof, Johannes
    Department of Epidemiology and Data Science, Amsterdam UMC, VU University, Amsterdam, Netherlands.
    Maisonneuve, Patrick
    Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy.
    Abu Hilal, Mohammad
    Department of General Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, 25123, Italy.
    Besselink, Marc G.
    Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Amsterdam, Netherlands.
    Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 665Article in journal (Refereed)
    Abstract [en]

    Background: Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design: The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion: The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration: ISRCTN27483786. Registered on August 2, 2023. © 2023, BioMed Central Ltd., part of Springer Nature.

  • 10.
    Donker, Tara
    et al.
    Vrije University Amsterdam.
    van Straten, Annemieke
    Vrije University Amsterdam.
    Riper, Heleen
    Vrije University Amsterdam.
    Marks, Isaac
    Kings College London.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Clinical and Social Psychology. Linköping University, Faculty of Arts and Sciences.
    Cuijpers, Pim
    Vrije University Amsterdam.
    Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial2009In: Trials, E-ISSN 1745-6215, Vol. 10, no 59Article in journal (Refereed)
    Abstract [en]

    Background: Internet-based self-help is an effective preventive intervention for highly prevalent disorders, such as depression and anxiety. It is not clear, however, whether it is necessary to offer these interventions with professional support or if they work without any guidance. In case support is necessary, it is not clear which level of support is needed. This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support. Methods: In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email); (3) the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by email); (4) weekly scheduled contacts initiated by a coach, but no web-based intervention; (5) information only (through the internet). The interventions will consist of five weekly lessons. Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are drop-out from the intervention, quality of life, and economic costs. Other secondary outcome measures that may predict outcome are also studied, e. g. client satisfaction and problem-solving skills. Measures are taken at baseline (pre-test), directly after the intervention (post-test, five weeks after baseline), 3 months later, and 12 months later. Analysis will be conducted on the intention-to-treat sample. Discussion: This study aims to provide more insight into the clinical effectiveness, differences in drop-out rate and costs between interventions with and without support, and in particular different levels of support. This is important to know in relation to the dissemination of internet-based self-help interventions.

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  • 11.
    Ehlers, Anke
    et al.
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England; Kings Coll London, England; South London and Maudsley NHS Fdn Trust, England.
    Wild, Jennifer
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England.
    Warnock-Parkes, Emma
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England; Kings Coll London, England; South London and Maudsley NHS Fdn Trust, England.
    Grey, Nick
    Sussex Partnership NHS Fdn Trust, England.
    Murray, Hannah
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England.
    Kerr, Alice
    South London and Maudsley NHS Fdn Trust, England.
    Rozental, Alexander
    Karolinska Inst, Sweden.
    Beierl, Esther T.
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England.
    Tsiachristas, Apostolos
    Univ Oxford, England.
    Perera-Salazar, Rafael
    Univ Oxford, England.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institutet, Sweden.
    Clark, David M.
    Univ Oxford, England; Oxford Hlth NHS Fdn Trust, England; Kings Coll London, England; South London and Maudsley NHS Fdn Trust, England.
    A randomised controlled trial of therapist-assisted online psychological therapies for posttraumatic stress disorder (STOP-PTSD): trial protocol2020In: Trials, E-ISSN 1745-6215, TRIALS, Vol. 21, no 1, article id 355Article in journal (Refereed)
    Abstract [en]

    Background Over the last few decades, effective psychological treatments for posttraumatic stress disorder (PTSD) have been developed, but many patients are currently unable to access these treatments. There is initial evidence that therapist-assisted internet-based psychological treatments are effective for PTSD and may help increase access, but it remains unclear which of these treatments work best and are most acceptable to patients. This randomised controlled trial will compare a trauma-focussed and a nontrauma-focussed therapist-assisted cognitive behavioural Internet treatment for PTSD: Internet-delivered cognitive therapy for PTSD (iCT-PTSD) and internet-delivered stress management therapy (iStress-PTSD). Methods/design The study is a single-blind, randomised controlled trial comparing iCT-PTSD, iStress-PTSD and a 13-week wait-list condition, with an embedded process study. Assessors of treatment outcome will be blinded to trial arm. Two hundred and seventeen participants who meet DSM-5 criteria for PTSD will be randomly allocated by a computer programme to iCT-PTSD, iStress-PTSD or wait-list at a 3:3:1 ratio. The primary assessment point is at 13 weeks, and further assessments are taken at 6, 26, 39 and 65 weeks. The primary outcome measure is the severity of PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary measures of PTSD symptoms are the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the Impact of Event Scale-Revised (IES-R). Other symptoms and well-being will be assessed with the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder Scale (GAD-7), WHO (Five) Well-Being Index, Work and Social Adjustment Scale (WSAS), Endicott Quality of Life Scale (QoL), and Insomnia Sleep Index (ISI). Health economics analyses will consider quality of life, productivity, health resource utilisation, employment status and state benefits, and treatment delivery costs. Process analyses will investigate candidate mediators and moderators of outcome. Patient experience will be assessed by interview and questionnaire. Discussion This study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed therapist-assisted online cognitive behavioural treatment for people with posttraumatic stress disorder.

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  • 12.
    Eimontas, Jonas
    et al.
    Vilnius Univ, Lithuania.
    Gegieckaite, Goda
    Vilnius Univ, Lithuania.
    Asaciova, Irena
    Vilnius Univ, Lithuania.
    Sticinskaite, Nikol
    Vilnius Univ, Lithuania.
    Arcimaviciute, Livija
    Vilnius Univ, Lithuania.
    Savickaite, Dovile
    Vilnius Univ, Lithuania.
    Vaitiekunaite-Zubriakoviene, Donata
    Vilnius Univ, Lithuania; Vilnius Univ Hosp Santaros Klin, Lithuania.
    Polianskis, Marius
    Vilnius Univ, Lithuania.
    Gans, Jennifer
    Mindfulness Based Tinnitus Stress Reduct MBTSR, CA USA.
    Beukes, Eldre
    Anglia Ruskin Univ, England; Collaborat Initiat Univ Colorado Sch Med & Univ Pr, CO USA.
    Manchaiah, Vinaya
    Collaborat Initiat Univ Colorado Sch Med & Univ Pr, CO USA; Univ Colorado, CO USA; Univ Colorado Hosp, CO USA; Univ Pretoria, South Africa; Univ Pretoria, South Africa; Manipal Acad Higher Educ, India.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Karolinska Inst, Sweden.
    Lesinskas, Eugenijus
    Vilnius Univ, Lithuania.
    Internet-delivered cognitive behavioral therapy for tinnitus compared to Internet-delivered mindfulness for tinnitus: a study protocol of a randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 269Article in journal (Refereed)
    Abstract [en]

    BackgroundTinnitus affects around 15% of the population and can be a debilitating condition for a sizeable part of them. However, effective evidence-based treatments are scarce. One recommended treatment for tinnitus is cognitive behavioral therapy which has been found to be effective when delivered online. However, more treatments including mindfulness-based interventions have been studied recently in an attempt to facilitate the availability of effective treatments. There are promising findings showing great effects in reducing tinnitus-induced distress and some evidence about the efficacy of such intervention delivered online. However, there is a lack of evidence on how these two treatments compare against one another. Therefore, the aim of this study will be to compare Internet-delivered cognitive behavioral therapy for tinnitus against an Internet-delivered mindfulness-based tinnitus stress reduction intervention in a three-armed randomized controlled trial with a waiting list control condition.MethodsThis study will be a randomized controlled trial seeking to recruit Lithuanian-speaking individuals suffering from chronic tinnitus. The self-report measure Tinnitus Handicap Inventory will be used. Self-referred participants will be randomized into one of three study arms: Internet-delivered cognitive behavioral therapy, Internet-delivered mindfulness-based tinnitus stress reduction intervention, or a waiting-list control group. Post-treatment measures will be taken at the end of the 8-week-long intervention (or waiting). Long-term efficacy will be measured 3 and 12 months post-treatment.DiscussionInternet-delivered interventions offer a range of benefits for delivering evidence-based treatments. This is the first randomized controlled trial to directly compare Internet-delivered CBT and MBTSR for tinnitus in a non-inferiority trial.

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  • 13.
    Eimontas, Jonas
    et al.
    Vilnius Univ, Lithuania.
    Pakalniskiene, Vilmante
    Vilnius Univ, Lithuania.
    Biliunaite, Ieva
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Karolinska Inst, Sweden.
    A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 925Article in journal (Refereed)
    Abstract [en]

    Background: Depression is most common among the elderly and is associated with major impairment With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT). Methods: A minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and withinand between-group effect sizes will be calculated. Discussion: Internet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors.

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  • 14.
    Ericson, Jenny
    et al.
    Dalarna Univ, Sweden; Uppsala Univ, Sweden; Falun Cent Hosp, Sweden.
    Anagrius, Cecilia
    Falun Cent Hosp, Sweden.
    Rygaard, Agnes
    Falun Cent Hosp, Sweden.
    Guntram, Lisa
    Linköping University, Department of Thematic Studies, Technology and Social Change. Linköping University, Faculty of Arts and Sciences.
    Wendel, Sophia Brismar
    Danderyd Hosp, Sweden.
    Hesselman, Susanne
    Uppsala Univ, Sweden; Falun Cent Hosp, Sweden; Uppsala Univ, Sweden.
    Womens experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 658Article in journal (Refereed)
    Abstract [en]

    Background: Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous womens experiences of receiving an invitation to participate in a randomized controlled trial (RCT) of lateral episiotomy versus no episiotomy in vacuum-assisted delivery (EVA trial). Methods: This qualitative study was nested in the ongoing EVA trial. Data were collected through semistructured telephone interviews with 23 women regarding their experiences of the information and invitation to participate in the EVA trial. Interviews were audio-recorded and transcribed verbatim. A qualitative content analysis was used to analyse the interview contents. Results: Three main experience categories were identified among the participants. "Timing of trial information and understanding" revealed that women preferred to obtain information about the trial early on during pregnancy. "Reasons to consent to or decline participation in the trial" encompassed a variety of reasons for women to consent, such as goodwill for science or personal benefits, or to decline, such as not wanting to be randomized or fear of increased risk of having a vacuum-assisted delivery. "Thoughts evoked regarding childbirth" were diverse, ranging from not being affected at all to having increased anxiety. Conclusions: The womens experience of receiving an invitation to participate in an RCT of episiotomy in vacuum-assisted delivery varied widely, from immediately giving consent without further worries to increased anxiety or declining participation. Early and personal information with time for reflection was considered most satisfactory.

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  • 15.
    Fischer, Vinicius Jobim
    et al.
    Univ Luxembourg Campus, Luxembourg.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Billieux, Joel
    Univ Lausanne, Switzerland.
    Vogele, Claus
    Univ Luxembourg Campus, Luxembourg.
    A randomized controlled trial of an Internet-based emotion regulation intervention for sexual health: study protocol2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 706Article in journal (Refereed)
    Abstract [en]

    Introduction Emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility, and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2-TREpS (Portuguese acronym for Emotion Regulation training for sexual health) project are as follows: (a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction and (b) explore the effects of the intervention on (1) emotion regulation skills, (2) mental health, and (3) sexual self-perception. Methods and analysis The study will use a randomized controlled trial design. Eligible participants will be randomly allocated to one of two groups: intervention (Internet-based emotion regulation training) or waitlist control. Assessments will take place before the start of the trial, at the end of the trial, and at 6-month follow up, after which participants assigned to the waitlist control condition will receive the same intervention. Primary outcomes include sexual function and satisfaction and secondary outcomes self-report measures of depression, anxiety, difficulties in emotion regulation, and sexual self-perception. This intervention study is financed by the Luxembourg National Research Fund (FNS). Ethics and dissemination Ethics approval was obtained from the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.

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  • 16.
    Gonzalez, Manuel
    et al.
    Umea Univ, Sweden; Umea Univ, Sweden; Commonwealth Sci Res and Ind Org CSIRO, Australia.
    Sjolin, Ingela
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Bäck, Maria
    Linköping University, Department of Medical and Health Sciences, Division of Physiotherapy. Linköping University, Faculty of Medicine and Health Sciences. Sahlgrens Univ Hosp, Sweden.
    Michelsen, Halldora Ogmundsdottir
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Tanha, Tina
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Sandberg, Camilla
    Umea Univ, Sweden; Umea Univ, Sweden; Umea Univ, Sweden.
    Schiopu, Alexandru
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Leosdottir, Margret
    Lund Univ, Sweden; Skane Univ Hosp, Sweden.
    Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, article id 76Article in journal (Refereed)
    Abstract [en]

    BackgroundCardiac rehabilitation (CR) programs addressing risk factor management, educational interventions, and exercise contribute to reduce mortality after myocardial infarction (MI). However, the fulfillment of guideline-recommended CR targets is currently unsatisfactory. eHealth, i.e., the use of electronic communication for healthcare, including the use of mobile smartphone applications combined with different sensors and interactive computerized programs, offers a new array of possibilities to provide clinical care. The present study aims to assess the efficacy of a web-based application (app) designed to support persons in adhering to lifestyle advice and medication as a complement to traditional CR programs for improvement of risk factors and clinical outcomes in patients with MI compared with usual care.Methods/designAn open-label multi-center randomized controlled trial is being conducted at different CR centers from three Swedish University Hospitals. The aim is to include 150 patients with MI amp;lt;75years of age who are confident smartphone and/or Internet users. In addition to participation in CR programs according to the usual routine at each center, patients randomized to the intervention arm will receive access to the web-based app. A CR nurse reviews the patients self-reported data twice weekly through a medical interface at the clinic. The primary outcome of the study will be change in submaximal exercise capacity (in watts) between 2 and 4weeks after discharge and when the patient has completed his/her exercise program at the CR center, usually around 3-6months post-discharge. Secondary outcomes include changes in self-reported physical activity, objectively assessed physical activity by accelerometry, self-rated health, dietary, and smoking habits, body mass index, blood pressure, blood lipids, and glucose/HbA1c levels between inclusion and follow-up visits during the first year post-MI. Additionally, we will assess uptake and adherence to the application, the number of CR staff contacts, and the incidence of cardiovascular events at 1 and 3 years after the MI. Patient recruitment started in 2016, and the first study results are expected in the beginning of 2019.DiscussionThe present study will add evidence to whether electronic communication can be used to improve traditional CR programs for patients after MI.Trial registrationClinicalTrials.gov, NCT03260582. Retrospectively registered on 24 August 2017.

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  • 17.
    Halvarsson, Alexandra
    et al.
    Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden.
    Roaldsen, Kirsti Skavberg
    Karolinska Inst, Sweden; Sunnaas Rehabil Hosp, Norway; Oslo Metropolitan Univ, Norway.
    Nilsen, Per
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Dohrn, Ing-Mari
    Karolinska Inst, Sweden.
    Stahle, Agneta
    Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden.
    StayBalanced: implementation of evidence-based fall prevention balance training for older adults-cluster randomized controlled and hybrid type 3 trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 166Article in journal (Refereed)
    Abstract [en]

    BackgroundThe StayBalanced programme has shown positive effects on fall prevention, balance control and fear of falling. Despite convincing evidence on the efficacy and effectiveness of balance training, there is a gap between research findings and what is provided in community-based and clinical health care settings. Therefore, transferring evidence-based balance training into clinical practice is needed.MethodsThis project, designed as a hybrid type 3 trial, is a cluster-randomized study with a mixed-method design, carried out in primary health care settings. The aim is to investigate the effectiveness of two different strategies to facilitate the implementation of an intervention, the StayBalanced balance training programme, in primary health care, including evaluation of relative changes and maintenance in patient outcomes between intervention arms over 24months. The StayBalanced programme will be launched through a website with information on the balance training and how to use it in clinical practice. One implementation strategy will include close facilitation, i.e. support and close follow-ups initiated by the researchers, in addition to access to the website. The other strategy simply includes access to the StayBalanced website. Outcome measures in the project consist of implementation outcomes, such as acceptability, feasibility, fidelity and sustainability of the StayBalanced programme. Outcomes at an individual level for older adults participating in the training will include fall-related concerns, health-related quality of life, balance performance, gait, physical activity, muscle strength in lower extremities, number of falls and compliance with training.DiscussionThis study will generate new understanding of effective strategies for transferring research to clinical practice and thereby reduce an important knowledge gap, as well as aid decision-making for future implementation of evidence-based methods. Furthermore, it will contribute to improved balance and gait, increased level of physical activity and function, and improved health-related quality of life for the individuals participating in the programme.Trial registrationClinicalTrials.govNCT02909374. Registered on September 21, 2016

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  • 18.
    Harding, Andrew J. E.
    et al.
    Univ Lancaster, England.
    Morbey, Hazel
    Univ Lancaster, England.
    Ahmed, Faraz
    Univ Lancaster, England.
    Opdebeeck, Carol
    Manchester Metropolitan Univ, England.
    Wang, Ying-Ying
    Univ Lancaster, England.
    Williamson, Paula
    Univ Liverpool, England.
    Swarbrick, Caroline
    Univ Manchester, England.
    Leroi, Iracema
    Univ Manchester, England.
    Challis, David
    Univ Manchester, England.
    Davies, Linda
    Univ Manchester, England.
    Reeves, David
    Univ Manchester, England.
    Holland, Fiona
    Univ Manchester, England.
    Hann, Mark
    Univ Manchester, England.
    Hellström, Ingrid
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in East Östergötland.
    Hydén, Lars-Christer
    Linköping University, Department of Social and Welfare Studies, Division Ageing and Social Change. Linköping University, Faculty of Arts and Sciences.
    Burns, Alistair
    Univ Manchester, England.
    Keady, John
    Univ Manchester, England; Greater Manchester Mental Hlth NHS Fdn Trust, England.
    Reilly, Siobhan
    Univ Lancaster, England.
    Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions2018In: Trials, E-ISSN 1745-6215, Vol. 19, article id 247Article in journal (Refereed)
    Abstract [en]

    Background: The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia. Methods/design: Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design: 1 Focus groups and interviews with key stakeholder groups (people living with dementia, care partners, relevant health and social care professionals, researchers and policymakers) and a review of the literature will be undertaken to build a long list of outcomes. 2 Two rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with people living with dementia and care partners. A consensus meeting will be convened with key participant groups to discuss the key findings and finalise the COS. 3 A systematic literature review will be undertaken to assess the properties of tools and instruments to assess components of the COS. Measurement properties, validity and reliability will be assessed using the Consensus-based Standards for the Selection of Health Measurement (COSMIN) and COMET guidance. 4 A stated preference survey will elicit the preferences of key stakeholders for the outcomes identified as important to measure in the COS. Discussion: To the best of our knowledge, this study is the first to use a modified Delphi process to involve people living with dementia as a participant group. Though the study is confined to collecting data in the United Kingdom, use of the COS by researchers will enhance the comparability of studies evaluating non-pharmacological and community-based interventions.

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  • 19.
    Jensen, Martin
    et al.
    Philipps Univ Marburg, Germany.
    Huettenrauch, Eva
    Philipps Univ Marburg, Germany.
    Schmidt, Jennifer
    Univ Appl Sci, Germany.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Karolinska Inst, Sweden.
    Chavanon, Mira-Lynn
    Philipps Univ Marburg, Germany.
    Weise, Cornelia
    Philipps Univ Marburg, Germany.
    Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers2020In: Trials, E-ISSN 1745-6215, TRIALS, Vol. 21, no 1, article id 382Article in journal (Refereed)
    Abstract [en]

    Background

    Tinnitus is a particularly common condition and can have debilitating psychological consequences for certain people. Although several interventions have been helpful in teaching individuals to better cope with tinnitus, no cure exists at present. Neurofeedback is an emerging treatment modality in tinnitus. Previous studies, utilising an alpha/delta training protocol, have shown promise. However, they were characterised by small sample sizes and a lack of neurofeedback control conditions. Therefore, the aim of this study is to investigate whether an alpha/delta neurofeedback training protocol, compared to beta/theta neurofeedback or a diary control group, is effective in reducing not only the tinnitus sound perception but also the psychological symptoms associated with the condition.

    Methods

    The study is designed as a three-armed randomised controlled trial. Participants are randomly assigned to a) an established neurofeedback protocol for tinnitus (alpha/delta training), b) an active control group (beta/theta training) or c) a diary control group. In the 4-week intervention period, participants in both neurofeedback groups undergo 10 sessions, whereas participants in the diary control group complete a bi-weekly diary. The primary outcomes are between group differences in tinnitus sound perception change, as measured with the Tinnitus Magnitude Index (TMI), and changes in tinnitus distress, measured with the Tinnitus Handicap Inventory (THI), 4 weeks after the start of the intervention. Secondary outcome measures include changes in tinnitus distress, sleep quality, depressive symptoms and whether neurofeedback leads to specific power changes in the trained frequency bands.

    Discussion

    This is the first randomised controlled trial examining the efficacy of an alpha/delta neurofeedback training protocol in reducing tinnitus sound perception and the distress associated with the condition. Compared to former studies, the present study is designed to assess both the specificity of an alpha/delta neurofeedback training protocol by including an active comparator and beta/theta neurofeedback training, in addition to controlling for placebo effects by the inclusion of a diary control group. This study aims to contribute to an understanding of the influences of both specific and non-specific effects in neurofeedback treatment for tinnitus.

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  • 20.
    Jovarauskaite, Lina
    et al.
    Vilnius Univ, Lithuania.
    Dumarkaite, Austeja
    Vilnius Univ, Lithuania.
    Truskauskaite-Kuneviciene, Inga
    Vilnius Univ, Lithuania.
    Jovaisiene, Ieva
    Vilnius Univ, Lithuania.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, Department of Biomedical and Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences. Karolinska Inst, Sweden.
    Kazlauskas, Evaldas
    Vilnius Univ, Lithuania.
    Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 559Article in journal (Refereed)
    Abstract [en]

    Background: The demand for care during the COVID-19 pandemic has affected the mental health of healthcare workers (HCWs), thus increasing the need for psychosocial support services. Internet-based interventions have previously been found to reduce occupational stress. The study aims to test the effects of an Internet-based stress recovery intervention-FOREST-among HCWs. Methods: A randomized controlled trial (RCT) parallel group design with three measurement points will be conducted to assess the efficacy of an Internet-based stress recovery intervention FOREST for nurses. The FOREST intervention is a 6-week Internet-based CBT and mindfulness-based program which comprises of six modules: (1) Introduction, (2) Detachment (relaxation and sleep), (3) Distancing, (4) Mastery (challenge), (5) Control, and (6) Keeping the change alive. We will compare the intervention against a waiting list group at pre-test, post-test, and follow-up. Stress recovery, PTSD, complex PTSD, moral injury, the level of stress, depression, anxiety, and psychological well-being will be measured. Discussion: The study will contribute to the development of mental healthcare programs for the HCWs. Based on the outcomes of the study, the FOREST intervention can be further developed or offered to healthcare staff as a tool to cope with occupational stress.

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  • 21.
    Karlsson, Jan Olof
    et al.
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Drug Research.
    Jynge, Per
    Linköping University, Faculty of Medicine and Health Sciences. Linköping University, Department of Medical and Health Sciences, Division of Drug Research.
    Lundström, Ingemar
    Linköping University, Department of Physics, Chemistry and Biology, Sensor and Actuator Systems. Linköping University, Faculty of Science & Engineering.
    Ignarro, Louis J.
    Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Pharmacology.
    Letter in response to: "Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdosethe PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial"2019In: Trials, E-ISSN 1745-6215, Vol. 20, article id 380Article in journal (Other academic)
    Abstract [en]

    n/a

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  • 22.
    Kleiboer, A
    et al.
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Smit, J
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Bosmans, J
    Department of Health Sciences, Vrije Universiteit Amsterdam and EMGO+ Institute for Health and Care Research, Amsterdam, The Netherlands.
    Ruwaard, J
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Department of Clinical Neuroscience, Psychiatry Section, Karolinska Institutet.
    Topooco, Naira
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research.
    Berger, T
    Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
    Krieger, T
    Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.
    Botella, C
    Department of Psychology and Technology, Jaume University, Castellon, Spain.; Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain.
    Baños, R
    Department of Personalidad, Evaluación y Tratamiento Psicológicos, Valencia, Spain.
    Chevreul, K
    URC-ECO, Ile-de-France (AP-HP), Paris, France.
    Araya, R
    Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
    Cerga-Pashoja, A
    Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.
    Cieślak, R
    Department of Psychology, Szkoła Wyzsza Psychologii Społeczne, University of Social Sciences and Humanities, Warsaw, Poland.
    Rogala, A
    Department of Psychology, Szkoła Wyzsza Psychologii Społeczne, University of Social Sciences and Humanities, Warsaw, Poland.
    Vis, C
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.
    Draisma, S
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    van Schaik, A
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Kemmeren, L
    Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    Ebert, D
    Department of Clinical Psychology, Philipps University, Marburg, Germany.
    Berking, M
    Department of Clinical Psychology, Philipps University, Marburg, Germany.
    Funk, B
    Institut für elektronische Geschäftsprozesse, Leuphana University Lüneburg, Lüneburg, Germany.
    Cuijpers, P
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.
    Riper, H
    Section Clinical Psychology, Vrije Universiteit Amsterdam and EMGO+ Institute for Health Care and Research, Van der Boechorststraat 1, 1081 BT, Amsterdam, The Netherlands.; Department of Psychiatry, VU University Medical Centre and EMGO+ Institute for Health Care and Research, Amsterdam, The Netherlands.
    European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries2016In: Trials, E-ISSN 1745-6215, Vol. 17, no 1Article in journal (Refereed)
    Abstract [en]

    Background: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care.

    Methods/design: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country).

    Discussion: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment.

    Trial Registration: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

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  • 23.
    Kues, Johanna N.
    et al.
    University of Marburg, Germany.
    Janda, Carolyn
    University of Marburg, Germany.
    Kleinstaeuber, Maria
    University of Marburg, Germany.
    Weise, Cornelia
    Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences. Linköping University, The Swedish Institute for Disability Research.
    Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial2014In: Trials, E-ISSN 1745-6215, Vol. 15, no 472Article in journal (Refereed)
    Abstract [en]

    Background: With a prevalence of 3 to 8% among women of reproductive age, severe premenstrual symptoms are very common. Symptoms range from emotional and cognitive to physical changes. Severe symptoms (that is, premenstrual syndrome) can have a strong impact on everyday functioning and quality of life. Impairment can be as serious as that of dysthymic disorders. Many affected women receive either no treatment at all or are unsatisfied with their treatment. Although there is some evidence for the reduction of distress through cognitive behavioural therapy, there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach. Thus, this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome. Methods/design: The study is conducted as a randomised controlled trial. The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview. Eligible women are randomly assigned to either a treatment or a wait-list control group. The intervention is based on cognitive behavioural therapy principles and is provided via the internet. It consists of 14 different modules on which participants work over 8 consecutive weeks. In addition to written information, participants receive email feedback from a clinical psychologist on a weekly basis. Participants assigned to the wait-list receive the treatment after the end of the waiting period (8 weeks). The primary outcome measure is the Premenstrual Syndrome Impairment Measure. Secondary outcomes include the Premenstrual Syndrome Coping Measure, the Short-Form Social Support Questionnaire, the Questionnaire for the Assessment of Relationship Quality, and the Perceived Stress Scale. Data is collected during the premenstrual (luteal) phase at pre-treatment, post-treatment, and 6-month follow-up. Discussion: So far, there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome. The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options.

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  • 24.
    Larsson, Sara L.
    et al.
    Skane Univ Hosp, Sweden; Lund Univ, Sweden.
    Ekstrand, Elisabeth
    Skane Univ Hosp, Sweden; Lund Univ, Sweden.
    Dahlin, Lars
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Skane Univ Hosp, Sweden; Lund Univ, Sweden.
    Bjoerkman, Anders
    Univ Gothenburg, Sweden.
    Brogren, Elisabeth
    Skane Univ Hosp, Sweden; Lund Univ, Sweden.
    A self-managed exercise therapy program for wrist osteoarthritis: study protocol for a randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 628Article in journal (Refereed)
    Abstract [en]

    BackgroundPost-traumatic wrist osteoarthritis (OA) can eventually lead to pain, muscular weakness, and stiffness of the wrist, which can affect the function of the entire upper limb and reduce the quality of life. Although there is strong evidence that all patients with OA should be offered adequate education and exercises as a first-line treatment, an effective self-management program, including structured education and therapeutic exercises, has not yet been introduced for individuals with wrist OA. This trial aims to evaluate the effectiveness of an exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) compared to a training program with range of motion exercises (control group).MethodsThis is a single-blinded randomized controlled trial (RCT) with two treatment arms in patients with symptomatic and radiographically confirmed wrist OA. The trial will be conducted at a hand surgery department. The participants will be randomly assigned either to a neuromuscular exercise therapy program or to a training program with range of motion exercises only. Participants in both groups will receive a wrist orthosis and structured education on wrist anatomy, pathophysiology, and joint protective self-management strategies. The programs consist of home exercises that will be performed twice a day for 12 weeks. The Patient-Rated Wrist Evaluation (PRWE) is the primary outcome measure of pain and function. Wrist range of motion (ROM), grip strength, the Numeric Pain Rating scale (NPRS), Disabilities of the Arm, Shoulder, and Hand (DASH), the General Self-Efficacy Scale (GSES), Global Rating of Change (GROC), and conversion to surgery are the secondary measures of outcome. Assessments will be performed at baseline and at 3, 6, and 12 months after baseline by a blinded assessor.DiscussionThe upcoming results from this trial may add new knowledge about the effectiveness of a self-managed exercise therapy program on pain and function for individuals with wrist OA. If the present self-management program proves to be effective, it can redefine current treatment strategies and may be implemented in wrist OA treatment protocols.Trial registrationClinicalTrials.gov, NCT05367817. Retrospectively registered on 27 April 2022. https://clinicaltrials.gov.

  • 25.
    Lindner, Philip
    et al.
    Karolinska Institute, Sweden .
    Ivanova, Ekaterina
    Stockholm University, Sweden .
    Hoa Ly, Kien
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Stockholm University, Sweden .
    Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 437Article in journal (Refereed)
    Abstract [en]

    Background: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effects of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a smartphone application. The effect of added therapist support will also be studied. Methods/Design: One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups: 1, smartphone-supplemented iCBT with therapist support; 2, smartphone-supplemented iCBT without therapist support; or 3, an active waiting list control group with delayed treatment. Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment (days 24 and 48) and two follow-up assessments (12 and 36 months) to assess rapid and long-term effects. Discussion: To our knowledge, this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders. Hence, the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions. Limitations are discussed.

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  • 26.
    Ljunggren, Stefan
    et al.
    Södertalje Hospital, Sweden Karolinska Institute, Sweden.
    Hahn, Robert G
    Linköping University, Department of Medical and Health Sciences, Anesthesiology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Sinnescentrum, Department of Anaesthesiology and Surgery UHL.
    Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 97Article in journal (Refereed)
    Abstract [en]

    Background

    Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L) rather than to the nutrients.

    Methods

    Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine), muscle catabolism (urinary 3-methylhistidine), and wellbeing.

    Results

    Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (−48%) and was due to an increased insulin response (+51%). Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups.

    Conclusions

    Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery.

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  • 27.
    Ly, Kien Hoa
    et al.
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Carlbring, Per
    Umeå University, Sweden .
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 62Article in journal (Refereed)
    Abstract [en]

    Background: The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones). Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. less thanbrgreater than less thanbrgreater thanMethods: The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, Effective meditation). The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. less thanbrgreater than less thanbrgreater thanDiscussions: We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapists prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10 years it is now time to move to the next generation of information technology - smartphones - which are not only relevant for Swedish conditions but also for developing countries in the world which are increasingly empowered by mobile phones with Internet connection.

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  • 28.
    MacDowall, Anna
    et al.
    Uppsala Univ, Sweden.
    Löfgren, Håkan
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Karolinska Univ Hosp, Sweden.
    Edstrom, Erik
    Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden; Spine Ctr Stockholm, Sweden.
    Brisby, Helena
    Univ Gothenburg, Sweden.
    Parai, Catharina
    Univ Gothenburg, Sweden.
    Elmi-Terander, Adrian
    Spine Ctr Stockholm, Sweden.
    Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial2023In: Trials, E-ISSN 1745-6215, Vol. 24, no 1, article id 106Article in journal (Refereed)
    Abstract [en]

    Background Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy.Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations. Methods This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years. Discussion This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preser ving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM.

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  • 29.
    Manchaiah, Vinaya K. C.
    et al.
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Stephens, Dafydd
    Cardiff University, UK.
    Andersson, Gerhard
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Rönnberg, Jerker
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Lunner, Thomas
    Linköping University, The Swedish Institute for Disability Research. Linköping University, Department of Behavioural Sciences and Learning, Disability Research. Linköping University, Faculty of Arts and Sciences.
    Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial2013In: Trials, E-ISSN 1745-6215, Vol. 14, no 25Article in journal (Refereed)
    Abstract [en]

    Background

    Hearing impairment is one of the most frequent chronic conditions. Persons with a hearing impairment (PHI) have various experiences during their ‘journey’ through hearing loss. In our previous studies we have developed a ‘patient journey’ model of PHI and their communication partners (CPs). We suggest this model could be useful in internet-based pre-fitting counseling of a person with hearing disability (PHD).

    Methods/Design

    A randomized controlled trial (RCT) with waiting list control (WLC) design will be used in this study. One hundred and fifty eight participants with self-reported hearing disability (that is, score >20 in the Hearing Handicap Questionnaire (HHQ)) will be recruited to participate in this study. They will be assigned to one of two groups (79 participants in each group): (1) Information and counseling provision using the ‘patient journey’ model; and (2) WLC. They will participate in a 30 day (4 weeks) internet-based counseling program based on the ‘patient journey’ model. Various outcome measures which focuses on hearing disability, depression and anxiety, readiness to change and acceptance of hearing disability will be administered pre (one week before) and post (one week and six months after) intervention to evaluate the effectiveness of counseling.

    Discussion

    Internet-based counseling is being introduced as a viable option for audiological rehabilitation. We predict that the ‘patient journey’ model will have several advantages during counseling of a PHD. Such a program, if proven effective, could yield cost and time-efficient ways of managing hearing disability.

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  • 30.
    McCambridge, Jim
    et al.
    London School Hyg and Tropical Medicine, England .
    Bendtsen, Preben
    Linköping University, Department of Medical and Health Sciences, Social Medicine and Public Health Science. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in Central Östergötland, Department of Acute Health Care in Linköping.
    Bendtsen, Marcus
    Linköping University, Department of Computer and Information Science, Human-Centered systems. Linköping University, The Institute of Technology.
    Nilsen, Per
    Linköping University, Department of Medical and Health Sciences, Social Medicine and Public Health Science. Linköping University, Faculty of Health Sciences. Linköping University, Department of Medical and Health Sciences, Health Technology Assessment and Health Economics.
    Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1): study protocol for a randomized controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 49Article in journal (Refereed)
    Abstract [en]

    Background: Alcohol causes huge problems for population health and for society, which require interventions with individuals as well as populations to prevent and reduce harms. Brief interventions can be effective and increasingly take advantage of the internet to reach high-risk groups such as students. The research literature on the effectiveness of online interventions is developing rapidly and is confronted by methodological challenges common to other areas of e-health including attrition and assessment reactivity and in the design of control conditions. less thanbrgreater than less thanbrgreater thanMethods/design: The study aim is to evaluate the effectiveness of a brief online intervention, employing a randomized controlled trial (RCT) design that takes account of baseline assessment reactivity, and other possible effects of the research process. Outcomes will be evaluated after 3 months both among student populations as a whole including for a randomized no contact control group and among those who are risky drinkers randomized to brief assessment and feedback (routine practice) or to brief assessment only. A three-arm parallel groups trial will also allow exploration of the magnitude of the feedback and assessment component effects. The trial will be undertaken simultaneously in 2 universities randomizing approximately 15,300 students who will all be blinded to trial participation. All participants will be offered routine practice intervention at the end of the study. less thanbrgreater than less thanbrgreater thanDiscussion: This trial informs the development of routine service delivery in Swedish universities and more broadly contributes a new approach to the study of the effectiveness of online interventions in student populations, with relevance to behaviors other than alcohol consumption. The use of blinding and deception in this study raise ethical issues that warrant further attention.

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  • 31.
    Mechler, Jakob
    et al.
    Stockholm Univ, Sweden.
    Lindqvist, Karin
    Stockholm Univ, Sweden.
    Carlbring, Per
    Stockholm Univ, Sweden.
    Lilliengren, Peter
    Ersta Skondal Bracke Univ Coll, Sweden.
    Falkenström, Fredrik
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Inst, Sweden.
    Topooco, Naira
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Ctr M2Hlth, CA USA.
    Johansson, Robert
    Stockholm Univ, Sweden.
    Midgley, Nick
    Anna Freud Ctr, England; UCL, England.
    Edbrooke-Childs, Julian
    UCL, England; Anna Freud Natl Ctr Children & Families, England.
    Dahl, Hanne-Sofie J.
    Vestfold Hosp Trust, Norway; Univ Oslo, Norway.
    Sandell, Rolf
    Lund Univ, Sweden.
    Thoren, Agneta
    Erica Fdn, Sweden.
    Ulberg, Randi
    Univ Oslo, Norway; Uppsala Univ, Sweden; Diakonhjemmet Hosp, Norway.
    Bergsten, Katja Lindert
    Uppsala Univ, Sweden.
    Philips, Bjorn
    Stockholm Univ, Sweden.
    Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1Article in journal (Refereed)
    Abstract [en]

    Background

    Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICBT) for adolescent depression has demonstrated efficacy in previous trials. In order to broaden the range of evidence-based treatments for young people, we evaluated a newly developed affect-focused Internet-based psychodynamic treatment (IPDT) in a previous study with promising results. The purpose of the planned study is to evaluate the efficacy of IPDT for adolescent depression in a non-inferiority trial, comparing it to ICBT.

    Methods

    The study will employ a parallel randomized non-inferiority design (ratio 1:1; n = 270). Eligible participants are adolescents 15–19 years suffering from depression. The primary hypothesis is that IPDT will be non-inferior to ICBT in reducing depressive symptoms from pre-treatment to end of treatment. Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion. Additional data will be collected to evaluate cost-effectiveness as well as investigating predictors, moderators and mediators of outcome. In addition, we will examine long-term outcome up to 1 year after end of treatment. Diagnostic interviews with MINI 7.0 will be used to establish primary diagnosis of depression as well as ruling out any exclusion criteria. Both treatments consist of eight modules over 10 weeks, complemented with therapist support through text messages and weekly chat sessions. Primary outcome measure is the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR). Primary outcome will be analysed using data from all participants entering the study using a multilevel growth curve strategy based on the weekly measurements of QIDS-A17-SR. The non-inferiority margin is defined as d = 0.30.

    Discussion

    This trial will demonstrate whether IPDT is non-inferior to ICBT in the treatment of adolescent depression. The study might therefore broaden the range of evidence-based treatment alternatives for young people struggling with depression. Further analyses of data from this trial may increase our knowledge about “what works for whom” and the pathways of change for two distinct types of interventions.

    Trial registration

    ISRCTN12552584, Registered on 13 August 2019.

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  • 32.
    Miloff, Alexander
    et al.
    Stockholm University, Sweden.
    Lindner, Philip
    Stockholm University, Sweden; Karolinska Institute, Sweden.
    Hamilton, William
    Stockholm University, Sweden; Mimerse, Sweden.
    Reuterskiold, Lena
    Stockholm University, Sweden.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Institute, Sweden.
    Carlbring, Per
    Stockholm University, Sweden.
    Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial2016In: Trials, E-ISSN 1745-6215, Vol. 17, no 60Article in journal (Refereed)
    Abstract [en]

    Background: Traditional one-session exposure therapy (OST) in which a patient is gradually exposed to feared stimuli for up to 3 h in a one-session format has been found effective for the treatment of specific phobias. However, many individuals with specific phobia are reluctant to seek help, and access to care is lacking due to logistic challenges of accessing, collecting, storing, and/or maintaining stimuli. Virtual reality (VR) exposure therapy may improve upon existing techniques by facilitating access, decreasing cost, and increasing acceptability and effectiveness. The aim of this study is to compare traditional OST with in vivo spiders and a human therapist with a newly developed single-session gamified VR exposure therapy application with modern VR hardware, virtual spiders, and a virtual therapist. Methods/design: Participants with specific phobia to spiders (N = 100) will be recruited from the general public, screened, and randomized to either VR exposure therapy (n = 50) or traditional OST (n = 50). A behavioral approach test using in vivo spiders will serve as the primary outcome measure. Secondary outcome measures will include spider phobia questionnaires and self-reported anxiety, depression, and quality of life. Outcomes will be assessed using a non-inferiority design at baseline and at 1, 12, and 52 weeks after treatment. Discussion: VR exposure therapy has previously been evaluated as a treatment for specific phobias, but there has been a lack of high-quality randomized controlled trials. A new generation of modern, consumer-ready VR devices is being released that are advancing existing technology and have the potential to improve clinical availability and treatment effectiveness. The VR medium is also particularly suitable for taking advantage of recent phobia treatment research emphasizing engagement and new learning, as opposed to physiological habituation. This study compares a market-ready, gamified VR spider phobia exposure application, delivered using consumer VR hardware, with the current gold standard treatment. Implications are discussed.

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  • 33.
    Mourad, Ghassan
    et al.
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences.
    Strömberg, Anna
    Linköping University, Department of Medical and Health Sciences, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Jonsbu, Egil
    More and Romsdal Hospital Trust, Norway; Norwegian University of Science and Technology, Norway.
    Gustafsson, Mikael
    Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping. Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine.
    Johansson, Peter
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Cardiology in Linköping.
    Jaarsma, Tiny
    Linköping University, Department of Social and Welfare Studies, Division of Nursing Science. Linköping University, Faculty of Medicine and Health Sciences.
    Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study2016In: Trials, E-ISSN 1745-6215, Vol. 17, p. 1-12, article id 352Article in journal (Refereed)
    Abstract [en]

    Background: Patients with recurrent episodes of non-cardiac chest pain may experience cardiac anxiety and avoidance behavior, leading to increased healthcare utilization. These patients might benefit from help and support to evaluate the perception and management of their chest pain. The purpose of this study was to test the feasibility of a short guided Internet-delivered cognitive behavioural therapy (CBT) program and explore the effects on cardiac anxiety, fear of body sensations, depressive symptoms, and chest pain in patients with non-cardiac chest pain, compared with usual care. Methods: A pilot randomized controlled study was conducted. Fifteen patients with non-cardiac chest pain with cardiac anxiety or fear of body sensations, aged 22-76 years, were randomized to intervention (n = 7) or control (n = 8) groups. The four-session CBT program contained psychoeducation, physical activity, and relaxation. The control group received usual care. Data were collected before and after intervention. Results: Five of seven patients in the intervention group completed the program, which was perceived as user-friendly with comprehensible language, adequate and varied content, and manageable homework assignments. Being guided and supported, patients were empowered and motivated to be active and complete the program. Patients in both intervention and control groups improved with regard to cardiac anxiety, fear of body sensations, and depressive symptoms, but no significant differences were found between the groups. Conclusions: The Internet-delivered CBT program seems feasible for patients with non-cardiac chest pain, but needs to be evaluated in larger groups and with a longer follow-up period.

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  • 34.
    Müssener, Ulrika
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Computer and Information Science, Database and information techniques. Linköping University, The Institute of Technology.
    Karlsson, Nadine
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences.
    White, Ian R.
    Cambridge Institute of Public Health.
    McCambridge, Jim
    University of York.
    Bendtsen, Preben
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Local Health Care Services in West Östergötland, Department of Medical Specialist in Motala.
    SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)2015In: Trials, E-ISSN 1745-6215, Vol. 16, article id 140Article in journal (Refereed)
    Abstract [en]

    Background: Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results. Methods/design: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention. Discussion: The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt.

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  • 35.
    Normann, Maria
    et al.
    Univ Gothenburg, Sweden; NU Hosp Grp, Sweden.
    Ekerstad, Niklas
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. NU Hosp Grp, Sweden.
    Angenete, Eva
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Prytz, Mattias
    Univ Gothenburg, Sweden; NU Hosp Grp, Sweden; NU Hosp Grp, Sweden.
    Effect of comprehensive geriatric assessment for frail elderly patients operated for colorectal cancer - the colorectal cancer frailty study: study protocol for a randomized, controlled, multicentre trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 948Article in journal (Refereed)
    Abstract [en]

    Background: Colorectal cancer (CRC) is the third most common cancer worldwide, with a median age of 72-75 years at diagnosis. Curative treatment usually involves surgery; if left untreated, symptoms may require emergency surgery. Therefore, most patients will be accepted for surgery, despite of high age or comorbidity. It is known that elderly patients suffer higher risks after surgery than younger patients, in terms of complications and mortality. Assessing frailty and offering frail elderly patients individualized treatment according to the comprehensive geriatric assessment (CGA) and care concept has been shown to improve the outcome for frail elderly patients in other clinical contexts. Methods: This randomized controlled multicentre trial aims to investigate if CGA and care prior to curatively intended surgery for CRC in frail elderly patients will improve postoperative outcome. All patients >= 70 years with surgically curable CRC will be screened for frailty using the Clinical Frailty Scale (CFS-9). Frail patients will be offered inclusion. Randomization is stratified for colon or rectal cancer. Patients in the intervention group are, in addition to standard protocol, treated according to CGA and care. This consists of individualized assessments and interventions, established by a multiprofessional team. Patients in the control group are treated according to best known practice as stipulated by Swedish colorectal cancer treatment guidelines, within an enhanced recovery after surgery (ERAS) setting. The primary outcome is 90-day mortality. Secondary outcomes are the length of hospital stay and total number of hospital days within 3 months, discharge destination, 30-day readmission, ADL, safe medication assessment, CFS-9 score, complications, Health-Related Quality of Life (HRQoL) at 2-month follow-up in comparison to baseline measurements, health economical calculations including cost-effectiveness analysis based on costs of hospital care and primary care, mortality and HRQoL at baseline, 2- and 12-month follow-up and all-cause 1-year mortality. Discussion: The trial is the first of its size and extent to investigate intervention with CGA and care prior to surgery for CRC in frail elderly patients. If this addition proves to be favourable, it could have implications on future care of frail elderly patients with CRC.

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  • 36.
    Olofsson Bagge, Roger
    et al.
    University of Gothenburg, Sweden.
    Ny, Lars
    University of Gothenburg, Sweden.
    All-Ericsson, Charlotta
    Karolinska Institute, Sweden.
    Sternby Eilard, Malin
    University of Gothenburg, Sweden.
    Rizell, Magnus
    University of Gothenburg, Sweden.
    Cahlin, Christian
    University of Gothenburg, Sweden.
    Stierner, Ulrika
    University of Gothenburg, Sweden.
    Lönn, Ulf
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Hansson, Johan
    Karolinska University Hospital, Sweden.
    Ljuslinder, Ingrid
    Norrlands University Hospital, Sweden.
    Lundgren, Lotta
    Skåne University Hospital, Sweden.
    Ullenhag, Gustav
    Uppsala University, Sweden.
    Folke Kiilgaard, Jens
    University of Copenhagen, Denmark.
    Nilsson, Jonas
    University of Gothenburg, Sweden.
    Lindner, Per
    University of Gothenburg, Sweden.
    Correction: Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial (vol 15, 317, 2014)2015In: Trials, E-ISSN 1745-6215, Vol. 16, no 334Article in journal (Other academic)
    Abstract [en]

    n/a

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  • 37.
    Olofsson, Roger
    et al.
    University of Gothenburg, Sweden .
    Ny, Lars
    University of Gothenburg, Sweden .
    Sternby Eilard, Malin
    University of Gothenburg, Sweden .
    Rizell, Magnus
    University of Gothenburg, Sweden .
    Cahlin, Christian
    University of Gothenburg, Sweden .
    Stierner, Ulrika
    University of Gothenburg, Sweden .
    Lönn, Ulf
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Hansson, Johan
    Karolinska University Hospital, Sweden .
    Ljuslinder, Ingrid
    Norrlands University Hospital, Sweden .
    Lundgren, Lotta
    Skåne University Hospital, Sweden .
    Ullenhag, Gustav
    Uppsala University, Sweden .
    Folke Kiilgaard, Jens
    University of Copenhagen, Denmark .
    Nilsson, Jonas
    University of Gothenburg, Sweden .
    Lindner, Per
    University of Gothenburg, Sweden .
    Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial2014In: Trials, E-ISSN 1745-6215, Vol. 15, no 317Article in journal (Refereed)
    Abstract [en]

    Background: Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumor, metastatic disease will ultimately develop in approximately 50% of patients, with the liver being the most common site for metastases. The median survival for patients with liver metastases is between 6 and 12 months, and no treatment has in randomized trials ever been shown to prolong survival. A previous phase II trial using isolated hepatic perfusion (IHP) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period (26 versus 12 months). Methods/Design: This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care (BAC). Inclusion criteria include liver metastases (verified by biopsy) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography (PET-CT). The primary endpoint is overall survival at 24 months, with secondary endpoints including response rate, progression-free survival, and quality of life. The planned sample size is 78 patients throughout five years. Discussion: Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists. This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint.

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  • 38.
    Pakpour, Amir H.
    et al.
    Qazvin Univ Med Sci, Iran; Jonkoping Univ, Sweden.
    Fazeli, Sara
    Qazvin Univ Med Sci, Iran.
    Zeidi, Isa Mohammadi
    Qazvin Univ Med Sci, Iran.
    Alimoradi, Zainab
    Qazvin Univ Med Sci, Iran.
    Georgsson, Mattias
    Jonkoping Univ, Sweden.
    Broström, Anders
    Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Clinical Neurophysiology. Jonkoping Univ, Sweden.
    Potenza, Marc N.
    Yale Univ, CT USA; Yale Univ, CT USA; Yale Univ, CT USA; Connecticut Council Problem Gambling, CT USA; Connecticut Mental Hlth Ctr, CT USA.
    Effectiveness of a mobile app-based educational intervention to treat internet gaming disorder among Iranian adolescents: study protocol for a randomized controlled trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 229Article in journal (Refereed)
    Abstract [en]

    Background: The use of video games, a hobby for many teenagers in their leisure time, has brought with it a new potential for concerns. Internet gaming disorder (IGD) is a mental condition classified as a disorder due to addictive behaviors. It may include use of video games, both online and offline. Consequences of IGD may include introversion, social anxiety, mood swings, loneliness, sleep problems, behavioral problems, depression, low self-esteem, and increased violence. In order to design an app-based intervention for adolescents, a transtheoretical model (TTM) has been used. This widely used model in the field of behavioral change is also practical for health education programs. In addition, cognitive-behavioral therapy (CBT) has been used to make people more aware of their behaviors, feelings and thoughts and how to achieve behavioral change. The present study seeks to determine the effectiveness of this app-based intervention in in the treatment of IGD among adolescents. Method: In this single-blinded, randomized, controlled trial, 206 high-school adolescents aged 13 to 18 years in Qazvin city will be recruited. Eligible adolescents will be randomly assigned into intervention and control groups. Eight consecutive sessions delivered over 2 months and based on the TTM and CBT will be delivered through the app (named HAPPYTEEN) to the intervention group. The control group will receive a sleep hygiene intervention (8 consecutive sessions for 2 months) via the app. Data collection tools include the Internet Gaming Disorder Scale, Insomnia Severity Index, Depression, Anxiety, and Stress Scales, Stages of Change Questionnaire, Decision Balance, and Self-Efficacy. The study measures will be completed at baseline, post intervention, and 1 month and 3 months after the intervention. Discussion: The results of this intervention could be used as adjunct therapy for adolescents with IGD.

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  • 39.
    Smoktunowicz, Ewelina
    et al.
    SWPS Univ Social Sci and Humanities, Poland.
    Lesnierowska, Magdalena
    SWPS Univ Social Sci and Humanities, Poland.
    Cieslak, Roman
    SWPS Univ Social Sci and Humanities, Poland; Univ Colorado, CO 80907 USA.
    Carlbring, Per
    Stockholm Univ, Sweden; Univ Southern Denmark, Denmark.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Karolinska Inst, Sweden.
    Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial2019In: Trials, E-ISSN 1745-6215, Vol. 20, article id 338Article in journal (Refereed)
    Abstract [en]

    BackgroundMedical professionals are at high risk of job stress and burnout. Research shows that work-related stress can be reduced through enhancing psychological resources, in particular, self-efficacy and perceived social support. These psychological resources can operate either individually or sequentially: in line with the cultivation hypothesis, self-efficacy precedes and cultivates perceived social support, whereas according to the enabling hypothesis it is perceived social support that comes first and enables self-efficacy. Based on this theoretical framework we developed an internet-based intervention, Med-Stress, dedicated to healthcare providers and aimed at reducing job stress and burnout. Med-Stress contains two modules that enhance self-efficacy and perceived social support, which are tested in four variants reflected in four study conditions. We expect that sequential enhancement of resources: self-efficacy and social support or social support and self-efficacy will yield larger posttest results than individual enhancement.MethodsIn this four-arm randomized controlled trial we will test four variants of the Med-Stress intervention. The trial is open for professionally active medical providers aged at least 18 years (N=1200) with access to an Internet-connected device. We will compare the effects of two experimental conditions reflecting cultivation and enabling effects of self-efficacy and perceived social support (sequential enhancement of resources), and two active controls strengthening self-efficacy or perceived social support. Job stress and job burnout will be the primary outcomes, whereas depression, job-related traumatic stress, and work engagement will be secondary ones. Additionally, we will measure perceived social support, self-efficacy to manage job stress and burnout, and the ability to obtain social support, exposure to traumatic events, and users expectancy and credibility of the intervention. All assessments will be applied before the intervention, atposttest (at 3 or 6weeks depending on the study condition), and at 6-month and 12-month follow up. In the case of experimental groups, additional measurements will be taken after enhancing each resource.DiscussionResource-based interventions are relatively context-free and could potentially benefit medical professionals across the field. If Med-Stress is successful, its most effective variant could be implemented in the healthcare system as a standalone, supportive tool for employees.Trial registrationClinicalTrials.gov, NCT03475290 Registered on 23 March 2018.

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  • 40.
    Surano, Solmaz
    et al.
    Umea Univ, Sweden.
    Grip, Helena
    Umea Univ, Sweden; Umea Univ, Sweden.
    Öhberg, Fredrik
    Umea Univ, Sweden; Umea Univ, Sweden.
    Karlsson, Marcus
    Umea Univ, Sweden.
    Faergemann, Erik
    Sundsvall Reg Hosp, Sweden.
    Bjurman, Maria
    Solleftea Hosp, Sweden.
    Davidsson, Hugo
    Univ Gothenburg, Sweden.
    Ledin, Torbjörn
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Sensory Organs and Communication. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Sahlgrens Univ Hosp, Sweden.
    Lindell, Ellen
    Sodra Alvsborg Hosp, Sweden.
    Mathé, Jan
    Karolinska Inst, Sweden; Capio St Gorans Hosp, Sweden.
    Tjernström, Fredrik
    Lund Univ, Sweden.
    Tomanovic, Tatjana
    Karolinska Inst, Sweden.
    Granåsen, Gabriel
    Umea Univ, Sweden.
    Salzer, Jonatan
    Umea Univ, Sweden.
    Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 496Article in journal (Refereed)
    Abstract [en]

    Background: Dizziness and vertigo affect around 15% of adults annually and represent common reasons for contacting health services, accounting for around 3% of all emergency department visits worldwide. Vertigo is also associated with excessive use of diagnostic imaging and emergency care and decreased productivity, primarily because of work absenteeism. Vestibular rehabilitation is an evidence-based treatment for chronic dizziness and supervised group exercise therapy has recently been shown to be effective after vestibular neuritis, a common cause of acute onset vertigo. However, such interventions are not readily available and there is a need for more easily accessible tools. The purpose of this study is to investigate the effects on vestibular symptoms of a 6-week online vestibular rehabilitation tool after acute onset vertigo, with the aim of aiding vestibular rehabilitation by presenting a more accessible tool that can help to reduce recovery time. Methods: Three hundred twenty individuals diagnosed with acute vestibular syndrome (AVS) will be recruited from multiple hospitals in Sweden and the effects of an online vestibular rehabilitation tool, YrselTraning, on vestibular symptoms after acute onset vertigo will be compared to standard care (written instructions leaflet) in a two-armed, evaluator-blinded, multicenter randomized controlled trial. The primary outcome will be the Vertigo Symptom Scale Short Form (VSS-SF) score at 6 weeks after symptom onset. Secondary outcomes include effects of the intervention on activities of daily living, mood and anxiety, vestibular function recovery, mobility measures, health economic effects, and the reliability of the Swedish VSS-SF translation. Discussion: Participants using the online vestibular rehabilitation tool are expected to recover earlier and to a greater extent from their symptoms as compared to standard care. Since up to 50% of people with AVS without treatment develop persistent symptoms, effective treatment of AVS will likely lead to a higher quality of life and help reduce the societal costs associated with dizziness and vertigo.

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  • 41.
    Syrjälä, M. B.
    et al.
    Umea Univ, Sweden.
    Bennet, L.
    Lund Univ, Sweden; Reg Skane, Sweden; Lund Univ, Sweden; Lund Univ Hosp, Sweden.
    Dempsey, P. C.
    Baker Heart & Diabet Inst, Australia; Univ Cambridge, England; Univ Leicester, England.
    Fharm, E.
    Umea Univ, Sweden.
    Hellgren, M.
    Skaraborg Inst, Sweden.
    Jansson, S.
    Orebro Univ, Sweden; Uppsala Univ, Sweden.
    Nilsson, S.
    Linköping University, Department of Health, Medicine and Caring Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Nordendahl, M.
    Umea Univ, Sweden.
    Rolandsson, O.
    Umea Univ, Sweden.
    Rådholm, Karin
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Primary Care Center, Primary Health Care Center Kärna. Univ New South Wales, Australia.
    Ugarph-Morawski, A.
    Reg Stockholm, Sweden; Karolinska Inst, Sweden.
    Wändell, P.
    Karolinska Inst, Sweden.
    Wennberg, P.
    Umea Univ, Sweden.
    Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial - the ROSEBUD study2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 607Article in journal (Refereed)
    Abstract [en]

    Background: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM. Methods: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides. Discussion: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.

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  • 42.
    Thomas, Kristin
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Computer and Information Science, Database and information techniques. Linköping University, Faculty of Science & Engineering.
    Linderoth, Catharina
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Karlsson, Nadine
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Preben
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Local Health Care Services in West Östergötland, Department of Medical Specialist in Motala.
    Müssener, Ulrika
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial2017In: Trials, E-ISSN 1745-6215, Vol. 18, article id 156Article in journal (Refereed)
    Abstract [en]

    Background: Despite significant health risks, heavy drinking of alcohol among university students is a widespread problem; excessive drinking is part of the social norm. A growing number of studies indicate that short message service (SMS)-based interventions are cost-effective, accessible, require limited effort by users, and can enable continuous, real-time, brief support in real-world settings. Although there is emerging evidence for the effect of SMS-based interventions in reducing alcohol consumption, more research is needed. This study aims to test the effectiveness of a newly developed SMS-based intervention targeting excessive alcohol consumption among university and college students in Sweden. Methods: The study is a two-arm randomized controlled trial with an intervention (SMS programme) and a control (treatment as usual) group. Outcome measures will be investigated at baseline and at 3-month follow up. The primary outcome is total weekly alcohol consumption. Secondary outcomes are frequency of heavy episodic drinking, highest estimated blood alcohol concentration and number of negative consequences due to excessive drinking. Discussion: This study contributes knowledge on the effect of automatized SMS support to reduce excessive drinking among students compared with existing support such as Student Health Centres.

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  • 43.
    Thomas, Kristin
    et al.
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Bendtsen, Marcus
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Linderoth, Catharina
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Müssener, Ulrika
    Linköping University, Department of Medical and Health Sciences, Division of Community Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    mHealth smoking cessation intervention among high-school pupils (NEXit Junior): study protocol for a randomized controlled trial2018In: Trials, E-ISSN 1745-6215, Vol. 19, article id 648Article in journal (Refereed)
    Abstract [en]

    BackgroundMobile health (mHealth) interventions, using text messages to support high-school pupils to quit smoking, could be a novel and cost-effective approach. However, more research is needed, specifically to investigate long-term effectiveness. The study aims to evaluate the effectiveness of a newly developed mHealth intervention targeting smoking cessation among high-school pupils.MethodsThe study is a two-arm, randomized controlled trial with an intervention group (mHealth intervention) and a control group (treatment as usual: national smoking cessation help line). Outcome measures will be investigated at baseline and at 3, 6, and 12months follow-up. Primary outcome measures will be: prolonged abstinence and 4-week point prevalence of smoking abstinence. Secondary outcome measures will be: 7-day point prevalence of smoking abstinence; mean number of quit attempts since taking part in the study; number of uses of other smoking cessation services since first invitation to the study and number of cigarettes smoked weekly if still smoking.DiscussionHigh schools in Sweden are bound by law to offer a smoke-free environment. However, little effort has been made to offer support to pupils who wish to quit smoking; rather the emphasis is on prevention of uptake. The study will examine the effectiveness of a stand-alone mHealth intervention targeting smokers among high-school pupils.Trial registrationThe trial was not retrospectively registered and has been registered at ISRCTN with the unique identification number ISRCTN15396225. The trial was registered on 13 October 2017.

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  • 44.
    Toft, Palle
    et al.
    Department Anaesthesiology and Intensive Care, Odense University Hospital, Sdr. Boulevard 29, DK - 5000 Odense C, Denmark .
    Olsen, Hanne Tanghus
    Department Anaesthesiology and Intensive Care, Svendborg Hospital, Valdemarsgade 5 5700 Svendborg, Denmark, .
    Jørgensen, Helene Korvenius
    Department Anaesthesiology and Intensive Care, Hospital Lillebaelt, Skovvangen 2-8, 6000 Kolding, Denmark .
    Strøm, Thomas
    Department Anaesthesiology and Intensive Care, Odense University Hospital, Sdr. Boulevard 29, DK - 5000 Odense C, Denmark .
    Nibro, Helle Lykkeskov
    Department Anaesthesiology and Intensive Care, Aarhus University Hospital Nørrebrogade 44, 8000 Aarhus, Denmark .
    Oxlund, Jacob
    Department Anaesthesiology and Intensive Care, Esbjerg Hospital, Frihedsvej 15, 6700 Esbjerg, Denmark .
    Wian, Karl-Andre
    Department Anaesthesiology and Intensive Care, Vestfold Hospital, Halfdan Wilhelmsens alle 17, 3116 Tonsberg, Norway. .
    Ytrebø, Lars Marius
    Department Anaesthesiology and Intensive Care, University Hospital of North Norway .
    Kroken, Bjørn Anders
    Department Anaesthesiology and Intensive Care, University Hospital of North Norway .
    Chew, Michelle
    8Department Anaesthesiology and Intensive Care, Hallands Hospital, Lasarettsvägen, 302 33 Halmstad, Sweden. .
    Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial2014In: Trials, E-ISSN 1745-6215, Vol. 15, no 499, p. 1-11Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients.

    METHODS/DESIGN: The non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium-free days; highest RIFLE score; days until discharge from the intensive care unit (within 28 days); days until the participant is without mechanical ventilation (within 28 days); and proportion of patients with a major cardiovascular outcome. Explorative outcomes will be: all cause mortality at 28 days after randomisation; days until discharge from the intensive care unit; days until the participant is without mechanical ventilation; days until discharge from the hospital; organ failure.Trial size: we will include 700 participants (2 × 350) in order to detect or reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%).

    DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.

    TRIAL REGISTER: ClinicalTrials.gov NCT0196768, 09.01.2014.

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  • 45.
    Tulbure, Bogdan Tudor
    et al.
    Babes-Bolyai University, Cluj-Napoca, Romania .
    Månsson, Kristoffer N T
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Andersson, Gerhard
    Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences.
    Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 202Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Social anxiety disorder (SAD) is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT) has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania.

    METHODS: Participants with social anxiety disorder (N = 96) will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a) an active treatment, or b) a waiting list control group.The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention). Liebowitz Social Anxiety Scale - Self-Report version (LSAS-SR) will be the primary outcome measure and will be administrated on a weekly basis in both conditions.

    DISCUSSION: The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania.

    TRIAL REGISTRATION: ClinicalTrials.gov: NCT01557894.

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  • 46.
    Ulfsdotter Gunnarsson, Katarina
    et al.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Collier, Elizabeth S.
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences. RISE Res Inst Sweden, Sweden.
    Mccambridge, Jim
    Univ York, England.
    Bendtsen, Marcus
    Linköping University, Department of Health, Medicine and Caring Sciences, Division of Society and Health. Linköping University, Faculty of Medicine and Health Sciences.
    Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial2024In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 5Article in journal (Refereed)
    Abstract [en]

    IntroductionIndividuals' comprehension of the information provided in consent forms should fundamentally influence whether to participate initially in a study and later whether to remain a participant. Existing evidence, however, suggests that participants do not thoroughly read, comprehend, or recall the information in consent forms. This study aimed to better understand how well participants recalled trial procedure information in the consent materials they received prior to taking part in a trial of a digital alcohol intervention.MethodThis study was nested within an online effectiveness trial. The study included a contrast between two layout approaches to present the trial procedure information: one where all materials were shown on the same page (One page) and one where participants had to click on links to get materials for certain parts of the study information (Active request). Recall of trial procedures was measured 2 months post-randomization with four questions. Participants were also asked to leave a comment after each question.ResultOf the 2437 individuals who registered interest in the parent trial, 1197 were randomized to One page and 1240 were randomized to Active request. Approximately 90% consented to participate and 53% of the participants responded to the recall questionnaire. Contrasting the consent layout showed no marked differences between groups in three out of the four questions on recall of trial procedures. There was, however, evidence that recall of aspects of how personal data would be handled during the trial did differ between the two groups, with the Active request group reporting less recall than the One page group. Free-text comments were used to give nuance to the quantitative analysis.ConclusionParticipants exposed to different layouts of trial procedure information exhibited varying levels of information recall 2 months after consenting. The findings highlight the influence of the presentation of consent forms, which should be given attention when designing trials.Trial registrationISRCTN ISRCTN48317451. Registered 6 December 2018, https://www.isrctn.com/ISRCTN48317451

  • 47.
    van Hilst, Jony
    et al.
    Univ Amsterdam, Netherlands.
    Korrel, Maarten
    Univ Amsterdam, Netherlands.
    Lof, Sanne
    Univ Amsterdam, Netherlands; Inst Osped Fdn Poliambulanza, Italy.
    de Rooij, Thijs
    Univ Amsterdam, Netherlands.
    Vissers, Frederique
    Univ Amsterdam, Netherlands.
    Al-Sarireh, Bilal
    Morriston Hosp, Wales.
    Alseidi, Adnan
    Virginia Mason Med Ctr, WA 98101 USA.
    Bateman, Adrian C.
    Univ Hosp Southampton NHS Fdn Trust, England.
    Björnsson, Bergthor
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping.
    Boggi, Ugo
    Univ Pisa, Italy.
    Bratlie, Svein Olav
    Sahlgrens Univ Hosp, Sweden.
    Busch, Olivier
    Univ Amsterdam, Netherlands.
    Butturini, Giovanni
    Pederzoli Hosp, Italy.
    Casadei, Riccardo
    Univ Bologna, Italy.
    Dijk, Frederike
    Amsterdam UMC, Netherlands.
    Dokmak, Safi
    Beaujon Hosp, France.
    Edwin, Bjorn
    Oslo Univ Hosp, Norway; Inst Clin Med, Norway.
    van Eijck, Casper
    Erasmus MC Canc Inst, Netherlands.
    Esposito, Alessandro
    Univ Hosp Verona, Italy.
    Fabre, Jean-Michel
    Hop St Eloi, France.
    Falconi, Massimo
    Univ Vita Salute, Italy.
    Ferrari, Giovanni
    Osped Niguarda Ca Granda, Italy.
    Fuks, David
    Inst Mutualiste Montsouris, France.
    Koerkamp, Bas Groot
    Erasmus MC Canc Inst, Netherlands.
    Hackert, Thilo
    Heidelberg Univ Hosp, Germany.
    Keck, Tobias
    Dept Surg, Germany.
    Khatkov, Igor
    Moscow Clin Sci Ctr, Russia.
    de Kleine, Ruben
    Univ Med Ctr Groningen, Netherlands.
    Kokkola, Arto
    Univ Helsinki, Finland; Helsinki Univ Hosp, Finland.
    Kooby, David A.
    Emory Univ Hosp, GA 30322 USA.
    Lips, Daan
    Med Spectrum Twente, Netherlands.
    Luyer, Misha
    Catharina Hosp, Netherlands.
    Marudanayagam, Ravi
    Univ Hosp Birmingham, England.
    Menon, Krishna
    Kings Coll Hosp NHS Fdn Trust, England.
    Molenaar, Quintus
    Univ Med Ctr Utrecht, Netherlands.
    de Pastena, Matteo
    Univ Hosp Verona, Italy.
    Pietrabissa, Andrea
    IRCCS Policlin San Matteo Pavia, Italy.
    Rajak, Rushda
    Virginia Mason Med Ctr, WA 98101 USA.
    Rosso, Edoardo
    Inst Osped Fdn Poliambulanza, Italy.
    Sanchez Velazquez, Patricia
    Hosp del Mar, Spain.
    Saint Marc, Olivier
    Ctr Hosp Reg Orleans, France.
    Shah, Mihir
    Emory Univ Hosp, GA 30322 USA.
    Soonawalla, Zahir
    Oxford Univ Hosp NHS Fdn Trust, England.
    Tomazic, Ales
    Univ Med Ctr Ljubljana, Slovenia.
    Verbeke, Caroline
    Univ Oslo, Norway.
    Verheij, Joanne
    Amsterdam UMC, Netherlands.
    White, Steven
    Freeman Hosp Newcastle Upon Tyne, England.
    Wilmink, Hanneke W.
    Amsterdam UMC, Netherlands.
    Zerbi, Alessandro
    IRCCS, Italy; Humanitas Univ, Italy.
    Dijkgraaf, Marcel G.
    Univ Amsterdam, Netherlands.
    Besselink, Marc G.
    Univ Amsterdam, Netherlands.
    Abu Hilal, Mohammad
    Inst Osped Fdn Poliambulanza, Italy; Fdn Poliambulanza Inst Osped, Italy.
    Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 608Article in journal (Refereed)
    Abstract [en]

    Background: Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP. Methods/design: DIPLOMA is an international randomized controlled, patient- and pathologist-blinded, non-inferiority trial performed in 38 pancreatic centers in Europe and the USA. A total of 258 patients with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC of the pancreatic body or tail will be randomly allocated to MIDP (laparoscopic or robot-assisted) or ODP in a 1:1 ratio. The primary outcome is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin &gt;= 1 mm), which is assessed using a standardized histopathology assessment protocol. The sample size is calculated with the following assumptions: 5% one-sided significance level (alpha), 80% power (1-beta), expected R0 rate in the open group of 58%, expected R0 resection rate in the minimally invasive group of 67%, and a non-inferiority margin of 7%. Secondary outcomes include time to functional recovery, operative outcomes (e.g., blood loss, operative time, and conversion to open surgery), other histopathology findings (e.g., lymph node retrieval, perineural- and lymphovascular invasion), postoperative outcomes (e.g., clinically relevant complications, hospital stay, and administration of adjuvant treatment), time and site of disease recurrence, survival, quality of life, and costs. Follow-up will be performed at the outpatient clinic after 6, 12, 18, 24, and 36 months postoperatively. Discussion: The DIPLOMA trial is designed to investigate the non-inferiority of MIDP versus ODP regarding the microscopically radical resection rate of PDAC in an international setting.

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  • 48.
    Welen, Karin
    et al.
    Univ Gothenburg, Sweden.
    Overby, Anna K.
    Umea Univ, Sweden; Umea Univ, Sweden.
    Ahlm, Clas
    Umea Univ, Sweden.
    Freyhult, Eva
    Uppsala Univ, Sweden.
    Robinsson, David
    Dept Urol, Sweden.
    Jonsson Henningsson, Anna
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Microbiology. Region Jonkoping Cty, Sweden.
    Stranne, Johan
    Univ Gothenburg, Sweden.
    Bremell, Daniel
    Univ Gothenburg, Sweden.
    Angelin, Martin
    Umea Univ, Sweden.
    Lindquist, Elisabeth
    Umea Univ, Sweden.
    Buckland, Robert
    Umea Univ, Sweden; Umea Univ, Sweden.
    Carlsson, Camilla Thellenberg
    Umea Univ, Sweden.
    Pauksens, Karlis
    Univ Uppsala Hosp, Sweden.
    Bill-Axelsson, Anna
    Uppsala Univ, Sweden.
    Akre, Olof
    Karolinska Inst, Sweden.
    Ryden, Cecilia
    Lund Univ, Sweden.
    Wagenius, Magnus
    Lund Univ, Sweden.
    Bjartell, Anders
    Lund Univ, Sweden.
    Nilsson, Anna C.
    Lund Univ, Sweden.
    Styrke, Johan
    Umea Univ, Sweden.
    Repo, Johanna
    Umea Univ, Sweden.
    Balkhed Östholm, Åse
    Region Jonkoping Cty, Sweden.
    Niward, Katarina
    Region Jonkoping Cty, Sweden.
    Gisslen, Magnus
    Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
    Josefsson, Andreas
    Univ Gothenburg, Sweden; Umea Univ, Sweden; Umea Univ, Sweden.
    COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 209Article in journal (Other academic)
    Abstract [en]

    Objectives: The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design: Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants: Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umea University Hospital, Region Vasterbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator: Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi (R)) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes: The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation: Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking): This is an open-label trial. Numbers to be randomised (sample size): The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status: The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021.

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  • 49.
    Wode, Kathrin
    et al.
    Umea Univ, Sweden; Karolinska Univ Hosp, Sweden; Reg Canc Ctr Stockholm Gotland, Sweden.
    Nordberg, Johanna Hoek
    Reg Canc Ctr Stockholm Gotland, Sweden; Karolinska Inst, Sweden; Karolinska Inst, Sweden.
    Kienle, Gunver S.
    Univ Freiburg, Germany; Univ Witten Herdecke, Germany.
    Elander, Nils
    Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Oncology.
    Bernhardson, Britt-Marie
    Karolinska Inst, Sweden.
    Sunde, Berit
    Umea Univ, Sweden; Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden.
    Sharp, Lena
    Reg Canc Ctr Stockholm Gotland, Sweden; Karolinska Inst, Sweden.
    Henriksson, Roger
    Umea Univ, Sweden; Norrland Univ Hosp, Sweden.
    Fransson, Per
    Umea Univ, Sweden; Norrland Univ Hosp, Sweden.
    Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 783Article in journal (Refereed)
    Abstract [en]

    Background

    Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported.

    The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.

    Methods

    The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews.

    Discussion

    To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer.

    Trial registration

    EU Clinical Trial Register, EudraCT Number 2014-004552-64. Registered on 19 January 2016.

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  • 50.
    Yaqub, Sheraz
    et al.
    Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway. shya@ous-hf.no; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
    Bjørnbeth, Bjørn Atle
    Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
    Angelsen, Jon-Helge
    Department of Acute and Digestive Surgery, Haukeland University Hospital, Bergen, Norway; Departments of Clinical Medicine, University of Bergen, Bergen, Norway.
    Fristrup, Claus Wilki
    Department of Surgery, Odense University Hospital, Odense C, Denmark.
    Grønbech, Jon Erik
    Department of Gastrointestinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway; Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
    Hemmingsson, Oskar
    Department of Surgical and Perioperative Sciences, Umeå University, Umea, Sweden.
    Isaksson, Bengt
    Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
    Juel, Ingebjørg Soterud
    Department of Gastrointestinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
    Larsen, Peter Nørgaard
    Department of Gastrointestinal Surgery, Rigshospitalet, Copenhagen, Denmark.
    Lindell, Gert
    Department of Surgery, Skåne University Hospital, Lund, Sweden.
    Mortensen, Frank Viborg
    Department of Surgery, Aarhus University Hospital, Aarhus N, Denmark.
    Mortensen, Kim Erlend
    Department of Gastrointestinal Surgery, University Hospital of North, Tromsø, Norway.
    Rizell, Magnus
    Department of Transplantation, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Sandström, Per A
    Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Linköping. Linköping University, Department of Biomedical and Clinical Sciences, Division of Surgery, Orthopedics and Oncology.
    Sandvik, Oddvar Mathias
    Department of Gastrointestinal Surgery, Stavanger University Hospital, Stavanger, Norway.
    Sparrelid, Ernesto
    Division of Surgery, Department of Clinical Science, Intervention, and Technology (CLINTEC), Center for Digestive Diseases, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
    Taflin, Helena
    Department of Surgery, Institute of Clinical Sciences, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Taskén, Kjetil
    Institute for Cancer Research, Oslo University Hospital, and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
    Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 642Article in journal (Refereed)
    Abstract [en]

    Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver.

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