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  • 1.
    Adams, Sally
    et al.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Penton-Voak, Ian S.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Harmer, Catherine J.
    Univ Oxford, Warneford Hosp, Dept Psychiat, Oxford OX3 7JX, England.
    Holmes, Emily A.
    MRC Cognit & Brain Sci Unit, Cambridge CB2 7EF, England.
    Munafo, Marcus R.
    Univ Bristol, Sch Expt Psychol, Bristol BS8 1TU, Avon, England.
    Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, article id 161Article in journal (Refereed)
    Abstract [en]

    Background: We have developed a new paradigm that targets the recognition of facial expression of emotions. Here we report the protocol of a randomised controlled trial of the effects of emotion recognition training on mood in a sample of individuals with depressive symptoms over a 6-week follow-up period. Methods/Design: We will recruit 190 adults from the general population who report high levels of depressive symptoms (defined as a score >= 14 on the Beck Depression Inventory-II). Participants will attend a screening session and will be randomised to intervention or control procedures, repeated five times over consecutive days (Monday to Friday). A follow-up session will take place at end-of -treatment, 2-weeks and 6-weeks after training. Our primary study outcome will be depressive symptoms, Beck Depression Inventory- II (rated over the past two weeks). Our secondary outcomes are: depressive symptoms, Hamilton Rating Scale for Depression; anxiety symptoms, Beck Anxiety Inventory (rated over the past month); positive affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); negative affect, Positive and Negative Affect Schedule (rated as 'how you feel right now'); emotion sensitivity, Emotion Recognition Task (test phase); approach motivation and persistence, the Fishing Game; and depressive interpretation bias, Scrambled Sentences Test. Discussion: This study is of a novel cognitive bias modification technique that targets biases in emotional processing characteristic of depression, and can be delivered automatically via computer, Internet or Smartphone. It therefore has potential to be a valuable cost-effective adjunctive treatment for depression which may be used together with more traditional psychotherapy, cognitive-behavioural therapy and pharmacotherapy.

  • 2.
    Adolfsson, Annsofie
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Lindén, Karolina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    Sparud Lundin, Carina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    Larsson, Per-Göran
    Department of Obstetrics and Gynecology, Skaraborg Hospital, Skövde, Sweden.
    Berg, Marie
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden.
    A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for arandomized controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, p. 513-Article in journal (Other academic)
    Abstract [en]

    Background: Women with type 1 diabetes face particular demands in their lives in relation to childbearing. During pregnancy, in order to optimize the probability of giving birth to a healthy child, their blood glucose levels need to be as normal as possible. After childbirth, they experience a 'double stress': in addition to the ordinary challenges they face as new mothers, they also need to focus on getting their blood glucose levels normal. To improve self-management of diabetes and overall well-being in women with type 1 diabetes, a person-centered web-based support was designed to be tested in a randomized controlled trial (RCT) to be used during pregnancy and early motherhood. This protocol outlines the design of this RCT, which will evaluate the effectiveness of the specially designed web-based support for mothers with type 1 diabetes in Sweden.

    Methods: The study is designed as an RCT. The web support consists of three parts: 1) evidence-based information, 2) a self-care diary, and 3) communication with peers. The primary outcome is general well-being evaluated with the Well-Being Questionnaire short version (W-BQ12) and diabetes management evaluated with the Diabetes Empowerment Scale, short version (SWE-DES). Women attending six hospital-based antenatal care centers in Sweden are invited to participate. The inclusion period is November 2011 to late 2014. The allocation of participants to web support (intervention group) and to usual care (control group) is equal (1:1). In total, 68 participants in each group will be needed to reach a statistical power of 80% with significance level 0.05.

    Discussion: The web support is expected to strengthen the women's personal capacity and autonomy during pregnancy, breastfeeding, and early motherhood, leading to optimal well-being and diabetes management.

  • 3.
    Afsharnejad, Bahareh
    et al.
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Falkmer, Marita
    Jönköping University, School of Education and Communication, HLK, CHILD. Jönköping University, School of Health and Welfare, HHJ. CHILD. School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Black, Melissa H.
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Alach, Tasha
    Autism Association of Western Australia, Perth, WA, Australia.
    Lenhard, Fabian
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Fridell, Anna
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Coco, Christina
    Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet and Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.
    Milne, Kelly
    Autism Association of Western Australia, Perth, WA, Australia.
    Chen, Nigel T. M.
    Curtin Autism Research Group (CARG), Curtin University, Perth, WA, Australia.
    Bölte, Sven
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    Girdler, Sonya
    School of Occupational Therapy, Social Works and Speech Pathology, Curtin University, Kent street, Perth, WA, Australia.
    KONTAKT© for Australian adolescents on the autism spectrum: Protocol of a randomized control trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 687Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Individuals diagnosed with autism spectrum disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (1) replication of effects in additional clinical and cultural contexts, (2) designs that employ active control groups, (3) calculation of health economic benefits, (4) identification of the optimal training duration, and (5) measurement of individual goals and quality of life outcomes.

    METHOD/DESIGN:

    With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12-17 years (N = 90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking programme. Participants will attend both programmes in groups of 6-8 adolescents, over 16 one-and-a-half-hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via the Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, and emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and healthcare costs.

    DISCUSSION:

    The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents' personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigorous evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD.

    TRIAL REGISTRATION:

    Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12617001117303. Registered on 31 July 2017. anzctr.org.au ClinicalTrials.gov, NCT03294668. Registered on 22 September 2017. https://clinicaltrials.gov.

  • 4.
    Almeida, Osvaldo P.
    et al.
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia;Royal Perth Hosp, Dept Psychiat, Perth, WA 6000, Australia.
    MacLeod, Colin
    Univ Western Australia, Sch Psychol, Crawley, WA 6009, Australia.
    Ford, Andrew
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia;Royal Perth Hosp, Dept Psychiat, Perth, WA 6000, Australia.
    Grafton, Ben
    Univ Western Australia, Sch Psychol, Crawley, WA 6009, Australia.
    Hirani, Varsha
    Univ Western Australia, Perkins Inst Med Res, Med Res Ctr, Western Australian Ctr Hlth & Ageing M573, Crawley, WA 6009, Australia;Univ Western Australia, Sch Psychiat & Clin Neurosci, Crawley, WA 6009, Australia.
    Glance, David
    Univ Western Australia, Ctr Software Practice, Crawley, WA 6009, Australia.
    Holmes, Emily A.
    MRC, Cognit & Brain Sci Unit, Cambridge CB2 7EF, England.
    Cognitive bias modification to prevent depression (COPE): study protocol for a randomised controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, article id 282Article in journal (Refereed)
    Abstract [en]

    Background: Depression is a leading cause of disability worldwide and, although efficacious treatments are available, their efficacy is suboptimal and recurrence of symptoms is common. Effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder, but current options are limited. Cognitive bias modification (CBM) is a novel, simple, and safe intervention that addresses attentional and interpretive biases associated with anxiety, dysphoria, and depression. The primary aim of this trial is to determine if CBM decreases the one-year onset of a major depressive episode among adults with subsyndromal depression. Design and methods: This randomised controlled trial will recruit 532 adults with subsyndromal symptoms of depression living in the Australian community (parallel design, 1:1 allocation ratio). Participants will be free of clinically significant symptoms of depression and of psychotic disorders, sensory and cognitive impairment, and risky alcohol use. The CBM intervention will target attentional and interpretive biases associated with depressive symptoms. The sessions will be delivered via the internet over a period of 52 weeks. The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria over a 12-month period. Secondary outcomes of interest include change in the severity of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9), use of antidepressants or benzodiazepines, and changes in attention and interpretive biases. The assessment of outcomes will take place 3, 6, 9, and 12 months after randomisation and will occur via the internet. Discussion: We propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available. The intervention is simple, inexpensive, easy to access, and could be easily rolled out into practice if our findings confirm a role for CBM in the prevention of depression.

  • 5. Atuhairwe, Susan
    et al.
    Byamugisha, Josaphat
    Klingberg-Allvin, Marie
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Cleeve, Amanda
    Hanson, Claudia
    Tumwesigye, Nazarius Mbona
    Kakaire, Othman
    Danielsson, Kristina Gemzell
    Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 376Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians.

    METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 μg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant.

    DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

  • 6.
    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, ISSN 1745-6215, 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’.

  • 7.
    Bartley, Andreas
    et al.
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden..
    Jakola, Asgeir S.
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden.;St Olavs Hosp, Dept Neurosurg, N-7006 Trondheim, Norway..
    Bartek, Jiri, Jr.
    Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden.;Rigshosp, Dept Neurosurg, Copenhagen Univ Hosp, Copenhagen, Denmark..
    Sundblom, Jimmy
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
    Förander, Petter
    Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden..
    Marklund, Niklas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
    Tisell, Magnus
    Sahlgrens Univ Hosp, Dept Neurosurg, Bla Straket 5, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Dept Clin Neurosci, Inst Neurosci & Physiol, Box 430, S-40530 Gothenburg, Sweden..
    The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 471Article in journal (Refereed)
    Abstract [en]

    Background: Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5-30% of patients, is a major clinical problem. The temperature of the irrigation fluid used during evacuation of the hematoma might theoretically influence recurrence rates since irrigation fluid at body temperature (37 degrees C) may beneficially influence coagulation and cSDH solubility when compared to irrigation fluid at room temperature. Should no difference in recurrence rates be observed when comparing irrigation-fluid temperatures, there is no need for warmed fluids during surgery. Our main aim is to investigate the effect of irrigation-fluid temperature on recurrence rates and clinical outcomes after cSDH evacuation using a multicenter randomized controlled trial design.

    Methods: The study will be conducted in three neurosurgical departments with population-based catchment areas using a similar surgical strategy. In total, 600 patients fulfilling the inclusion criteria will randomly be assigned to either intraoperative irrigation with fluid at body temperature or room temperature. The power calculation is based on a retrospective study performed at our department showing a recurrence rate of 5% versus 12% when comparing irrigation fluid at body temperature versus fluid at room temperature (unpublished data). The primary endpoint is recurrence rate of cSDH analyzed at 6 months post treatment. Secondary endpoints are mortality rate, complications and health-related quality of life.

    Discussion: Irrigation-fluid temperature might influence recurrence rates in the evacuation of chronic subdural hematomas. We present a study protocol for a multicenter randomized controlled trial investigating our hypothesis that irrigation fluid at body temperature is superior to room temperature in reducing recurrence rates following evacuation of cSDH.

  • 8. Berglind, Daniel
    et al.
    Nyberg, Gisela
    Willmer, Mikaela
    Persson, Margareta
    Umeå University, Faculty of Medicine, Department of Nursing.
    Wells, Michael
    Forsell, Yvonne
    An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 258Article in journal (Refereed)
    Abstract [en]

    Background: Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. 

    Methods: The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability.

    Discussion: There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1).

  • 9.
    Berglind, Daniel
    et al.
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Nyberg, Gisela
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Willmer, Mikaela
    University of Gävle, Faculty of Health and Occupational Studies, Department of Health and Caring Sciences, Caring science.
    Persson, Margareta
    Department of Nursing, Umeå Universiy, Umeå, Sweden.
    Wells, Michael
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    Forsell, Yvonne
    Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
    An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, no 1, article id 258Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors.

    METHODS: The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability.

    DISCUSSION: There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1).

    TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.

  • 10.
    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, ISSN 1745-6215, 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.

  • 11.
    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, ISSN 1745-6215, 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.

  • 12.
    Bluth, T.
    et al.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Teichmann, R.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Kiss, T.
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Bobek, I.
    Semmelweis Egyet, Aneszteziol & Intenz Terapias Klin, Budapest, Hungary..
    Canet, J.
    Hosp Badalona Germans Trias & Pujol, Dept Anesthesiol, Badalona, Spain..
    Cinnella, G.
    Univ Foggia, Dept Anesthesiol & Intens Care Med, Foggia, Italy..
    De Baerdemaeker, L.
    Univ Ghent, Dept Anesthesiol, Ghent, Belgium..
    Gregoretti, C.
    Policlin P Giaccone, Dept Biopathol & Med Biotechnol, Palermo, Italy..
    Hedenstierna, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Hemmes, S. N.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Hiesmayr, M.
    Med Univ Vienna, Div Cardiac Surg, Vienna, Austria.;Med Univ Vienna, Div Thorac Dis, Vienna, Austria.;Med Univ Vienna, Div Vasc Surg, Vienna, Austria.;Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria..
    Hollmann, M. W.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Jaber, S.
    St Eloi Univ Hosp, Dept Crit Care Med & Anesthesiol SAR B, Montpellier, France..
    Laffey, J. G.
    St Michaels Hosp, Dept Anesthesia, Crit Care Med Program, Toronto, ON, Canada.;Univ Toronto, Dept Anesthesia, Toronto, ON, Canada.;Univ Toronto, Dept Physiol, Toronto, ON, Canada.;Univ Toronto, Interdepartmental Div Crit Care Med, Toronto, ON, Canada..
    Licker, M. J.
    Univ Hosp Geneva, Dept Anesthesiol Pharmacol & Intens Care, Geneva, Switzerland..
    Markstaller, K.
    Med Univ Vienna, Dept Anesthesia Intens Care & Pain Med, Vienna, Austria..
    Matot, I.
    Tel Aviv Univ, Sackler Sch Med, Tel Aviv Med Ctr, Dept Anesthesia & Crit Care, Tel Aviv, Israel..
    Mueller, G.
    Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany..
    Mills, G. H.
    Sheffield Teaching Hosp, OSCCA, Sheffield, S Yorkshire, England.;Univ Sheffield, Sheffield, S Yorkshire, England..
    Mulier, J. P.
    AZ Sint Jan Brugge Oostende AV, Dept Anesthesiol, Brugge, Belgium..
    Putensen, C.
    Univ Bonn, Dept Anesthesiol & Intens Care Med, Bonn, Germany..
    Rossaint, R.
    Univ Aachen, Dept Anesthesiol, Aachen, Germany..
    Schmitt, J.
    Tech Univ Dresden, Ctr Evidence Based Healthcare, Univ Hosp, Dresden, Germany.;Tech Univ Dresden, Med Fac Carl Gustav Carus, Dresden, Germany..
    Senturk, M.
    Istanbul Univ, Istanbul Fac Med, Dept Anesthesiol & Intens Care Med, Istanbul, Turkey..
    Serpa Neto, A.
    Fac Med ABC, Hosp Israelita Albert Einstein, Dept Crit Care Med, Sao Paulo, Brazil.;Fac Med ABC, Program Postgrad Res & Innovat, Sao Paulo, Brazil..
    Severgnini, P.
    Univ Insubria, Dept Biotechnol & Sci Life, ASST Sette Laghi, Osped Cricolo & Fdn Macchi, Varese, Italy..
    Sprung, J.
    Mayo Clin, Dept Anesthesiol, Rochester, MN USA..
    Melo, M. F. Vidal
    Massachusetts Gen Hosp, Harvard Med Sch, Dept Anesthesia Crit Care & Pain Med, Boston, MA 02114 USA..
    Wrigge, H.
    Univ Leipzig, Dept Anesthesiol & Intens Care Med, Leipzig, Germany..
    Schultz, M. J.
    Univ Amsterdam, Acad Med Ctr, Dept Anesthesiol, Amsterdam, Netherlands.;Univ Amsterdam, Acad Med Ctr, LEICA, Amsterdam, Netherlands..
    Pelosi, P.
    Univ Genoa, IRCCS AOU San Martino IST, Dept Surg Sci & Integrated Diagnost, Genoa, Italy..
    de Abreu, M. Gama
    Univ Hosp Carl Gustav Carus, Dept Anesthesiol & Intens Care Med, Pulmonary Engn Grp, Dresden, Germany..
    Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 202Article in journal (Refereed)
    Abstract [en]

    Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.

    Methods/design: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index >= 35 kg/m(2) scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH(2)O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH(2)O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.

    Discussion: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.

  • 13. Bluth, T
    et al.
    Teichmann, R
    Kiss, T
    Bobek, I
    Canet, J
    Cinnella, G
    De Baerdemaeker, L
    Gregoretti, C
    Hedenstierna, Göran
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Hedenstierna laboratory.
    Hemmes, S N
    Hiesmayr, M
    Hollmann, M W
    Jaber, S
    Laffey, J G
    Licker, M J
    Markstaller, K
    Matot, I
    Müller, G
    Mills, G H
    Mulier, J P
    Putensen, C
    Rossaint, R
    Schmitt, J
    Senturk, M
    Neto, A Serpa
    Severgnini, P
    Sprung, J
    Vidal Melo, M F
    Wrigge, H
    Schultz, M J
    Pelosi, P
    Gama de Abreu, Marcelo
    Erratum to Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 247Article in journal (Refereed)
  • 14.
    Boettcher, Johanna
    et al.
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Andersson, Gerhard
    Carlbring, Per
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, no 68Article 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.

  • 15.
    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, ISSN 1745-6215, 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

  • 16.
    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, ISSN 1745-6215, 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

  • 17.
    Carlbring, Per
    et al.
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Lindner, Philip
    Martell, Christopher
    Hassmén, Peter
    Forsberg, Lars
    Ström, Lars
    Andersson, Gerhard
    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, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, p. 35-Article 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.

  • 18. Carlbring, Per
    et al.
    Lindner, Philip
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Martell, Christopher
    Hassmén, Peter
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Forsberg, Lars
    Ström, Lars
    Umeå University, Faculty of Social Sciences, Department of Psychology.
    Andersson, Gerhard
    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, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, p. 35-Article 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.

  • 19.
    Casey, Máire-Bríd
    et al.
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Smart, Keith
    St Vincents Univ Hosp, Physiotherapy Dept, Elm Pk, Dublin, Ireland.
    Segurado, Ricardo
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Hearty, Conor
    Mater Misericordiae Univ Hosp, Dept Pain Med, Eccles St, Dublin, Ireland.
    Gopal, Hari
    Mater Misericordiae Univ Hosp, Dept Pain Med, Eccles St, Dublin, Ireland.
    Lowry, Damien
    Mater Misericordiae Univ Hosp, Psychol Dept, Eccles St, Dublin, Ireland.
    Flanagan, Dearbhail
    Mater Misericordiae Univ Hosp, Physiotherapy Dept, Eccles St, Dublin, Ireland.
    McCracken, Lance
    Kings Coll London, Inst Psychiat Psychol & Neurosci, Psychol Dept, London, England.
    Doody, Catherine
    Univ Coll Dublin, Sch Publ Hlth Physiotherapy & Sports Sci, Hlth Sci Bldg, Dublin, Ireland.
    Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 194Article in journal (Refereed)
    Abstract [en]

    Background: Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise.

    Methods/design: This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit ZipTM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a purposeful sample of participants to explore patient experiences of both treatments.

    Discussion: To our knowledge, this will be the first RCT to examine whether combining exercise with ACT produces greater benefit for patients with chronic pain, compared to a standalone supervised exercise programme.

    Trial registration: www.ClinicalTrials.gov, ID: NCT03050528. Registered on 13 February 2017.

  • 20. Eriksson, Leif
    et al.
    Huy, Tran Q
    Duc, Duong M
    Ekholm Selling, Katarina
    Hoa, Dinh P
    Thuy, Nguyen T
    Nga, Nguyen T
    Persson, Lars-Åke
    Wallin, Lars
    Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Karolinska institutet.
    Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, article id 23Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Annually, 2.8 million neonatal deaths occur worldwide, despite the fact that three-quarters of them could be prevented if available evidence-based interventions were used. Facilitation of community groups has been recognized as a promising method to translate knowledge into practice. In northern Vietnam, the Neonatal Health - Knowledge Into Practice trial evaluated facilitation of community groups (2008-2011) and succeeded in reducing the neonatal mortality rate (adjusted odds ratio, 0.51; 95 % confidence interval 0.30-0.89). The aim of this paper is to report on the process (implementation and mechanism of impact) of this intervention.

    METHODS: Process data were excerpted from diary information from meetings with facilitators and intervention groups, and from supervisor records of monthly meetings with facilitators. Data were analyzed using descriptive statistics. An evaluation including attributes and skills of facilitators (e.g., group management, communication, and commitment) was performed at the end of the intervention using a six-item instrument. Odds ratios were analyzed, adjusted for cluster randomization using general linear mixed models.

    RESULTS: To ensure eight active facilitators over 3 years, 11 Women's Union representatives were recruited and trained. Of the 44 intervention groups, composed of health staff and commune stakeholders, 43 completed their activities until the end of the study. In total, 95 % (n = 1508) of the intended monthly meetings with an intervention group and a facilitator were conducted. The overall attendance of intervention group members was 86 %. The groups identified 32 unique problems and implemented 39 unique actions. The identified problems targeted health issues concerning both women and neonates. Actions implemented were mainly communication activities. Communes supported by a group with a facilitator who was rated high on attributes and skills (n = 27) had lower odds of neonatal mortality (odds ratio, 0.37; 95 % confidence interval, 0.19-0.73) than control communes (n = 46).

    CONCLUSIONS: This evaluation identified several factors that might have influenced the outcomes of the trial: continuity of intervention groups' work, adequate attributes and skills of facilitators, and targeting problems along a continuum of care. Such factors are important to consider in scaling-up efforts.

  • 21.
    Eriksson, Leif
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Huy, Tran Q
    Nursing office, Department of Medical Services Administration, Ministry of Health Vietnam.
    Duc, Duong M
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH). Hanoi School of Public Health, Hanoi, Vietnam.
    Ekholm Selling, Katarina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Hoa, Dinh P
    Hanoi School of Public Health, Vietnam.
    Thuy, Nguyen T
    Vietnam Sweden Uong Bi General Hospital, Quang Ninh, Vietnam.
    Nga, Nguyen Thu
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health. Vietnam Sweden Uong Bi General Hospital, Quang Ninh, Vietnam.
    Persson, Lars-Åke
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
    Wallin, Lars
    Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institutet. School of Education, Health and Social Studies, Dalarna University, Falun, Sweden..
    Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to impove neonatal survival in Quang Ninh province, Vietnam2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, no 1, article id 23Article in journal (Refereed)
    Abstract [en]

    Background

    Annually, 2.8 million neonatal deaths occur worldwide, despite the fact that three-quarters of them could be prevented if available evidence-based interventions were used. Facilitation of community groups has been recognized as a promising method to translate knowledge into practice. In northern Vietnam, the Neonatal Health – Knowledge Into Practice trial evaluated facilitation of community groups (2008–2011) and succeeded in reducing the neonatal mortality rate (adjusted odds ratio, 0.51; 95 % confidence interval 0.30–0.89). The aim of this paper is to report on the process (implementation and mechanism of impact) of this intervention.

    Methods

    Process data were excerpted from diary information from meetings with facilitators and intervention groups, and from supervisor records of monthly meetings with facilitators. Data were analyzed using descriptive statistics. An evaluation including attributes and skills of facilitators (e.g., group management, communication, and commitment) was performed at the end of the intervention using a six-item instrument. Odds ratios were analyzed, adjusted for cluster randomization using general linear mixed models.

    Results

    To ensure eight active facilitators over 3 years, 11 Women’s Union representatives were recruited and trained. Of the 44 intervention groups, composed of health staff and commune stakeholders, 43 completed their activities until the end of the study. In total, 95 % (n = 1508) of the intended monthly meetings with an intervention group and a facilitator were conducted. The overall attendance of intervention group members was 86 %. The groups identified 32 unique problems and implemented 39 unique actions. The identified problems targeted health issues concerning both women and neonates. Actions implemented were mainly communication activities. Communes supported by a group with a facilitator who was rated high on attributes and skills (n = 27) had lower odds of neonatal mortality (odds ratio, 0.37; 95 % confidence interval, 0.19–0.73) than control communes (n = 46).

    Conclusions

    This evaluation identified several factors that might have influenced the outcomes of the trial: continuity of intervention groups’ work, adequate attributes and skills of facilitators, and targeting problems along a continuum of care. Such factors are important to consider in scaling-up efforts.

  • 22.
    Falk Delgado, Alberto
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Plastic Surgery.
    Delgado, Anna Falk
    Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden..
    Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 354Article in journal (Refereed)
    Abstract [en]

    Background: Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Methods: Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. Results: A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). Conclusion: COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

  • 23.
    Falk Delgado, Alberto
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Plastic Surgery. Univ Uppsala Hosp, Akad Sjukhuset, S-75185 Uppsala, Sweden..
    Falk Delgado, Anna
    Karolinska Inst, Dept Clin Neurosci, Stockholm, Sweden.;Karolinska Univ Hosp, Neuroradiol, Stockholm, Sweden..
    The association of funding source on effect size in randomized controlled trials: 2013-2015-a cross-sectional survey and metaanalysis2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 125Article in journal (Refereed)
    Abstract [en]

    Background: Trials financed by for-profit organizations have been associated with favorable outcomes of new treatments, although the effect size of funding source impact on outcome is unknown. The aim of this study was to estimate the effect size for a favorable outcome in randomized controlled trials (RCTs), stratified by funding source, that have been published in general medical journals. Methods: Parallel-group RCTs published in The Lancet, New England Journal of Medicine, and JAMA between 2013 and 2015 were identified. RCTs with binary primary endpoints were included. The primary outcome was the OR of patients' having a favorable outcome in the intervention group compared with the control group. The OR of a favorable outcome in each trial was calculated by the number of positive events that occurred in the intervention and control groups. A meta-analytic technique with random effects model was used to calculate summary OR. Data were stratified by funding source as for-profit, mixed, and nonprofit. Prespecified sensitivity, subgroup, and metaregression analyses were performed. Results: Five hundred nine trials were included. The OR for a favorable outcome in for-profit-funded RCTs was 1.92 (95% CI 1.72-2.14), which was higher than mixed source-funded RCTs (OR 1.34, 95% CI 1.25-1.43) and nonprofit-funded RCTs (OR 1.32, 95% CI 1.26-1.39). The OR for a favorable outcome was higher for both clinical and surrogate endpoints in for-profit-funded trials than in RCTs with other funding sources. Excluding drug trials lowered the OR for a favorable outcome in for-profit-funded RCTs. The OR for a favorable surrogate outcome in drug trials was higher in for-profit-funded trials than in nonprofit-funded trials. Conclusions: For-profit-funded RCTs have a higher OR for a favorable outcome than nonprofit-and mixed source-funded RCTs. This difference is associated mainly with the use of surrogate endpoints in for-profit-financed drug trials.

  • 24. Ferrando, Carlos
    et al.
    Soro, Marina
    Canet, Jaume
    Carmen Unzueta, Ma
    Suarez-Sipmann, Fernando
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Hedenstierna laboratory.
    Librero, Julian
    Peiro, Salvador
    Llombart, Alicia
    Delgado, Carlos
    Leon, Irene
    Rovira, Lucas
    Ramasco, Fernando
    Granell, Manuel
    Aldecoa, Cesar
    Diaz, Oscar
    Balust, Jaume
    Garutti, Ignacio
    de la Matta, Manuel
    Pensado, Alberto
    Gonzalez, Rafael
    Eugenia Duran, Ma
    Gallego, Lucia
    Garcia del Valle, Santiago
    Redondo, Francisco J.
    Diaz, Pedro
    Pestana, David
    Rodriguez, Aurelio
    Aguirre, Javier
    Garcia, Jose M.
    Garcia, Javier
    Espinosa, Elena
    Charco, Pedro
    Navarro, Jose
    Rodriguez, Clara
    Tusman, Gerardo
    Javier Belda, Francisco
    Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 193Article in journal (Refereed)
    Abstract [en]

    Background: Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. Methods: This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra-and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra-and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. Discussion: The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications.

  • 25.
    Flink, Maria
    et al.
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Karolinska Institutet;Karolinska University Hospital.
    Brandberg, Carina
    Karolinska Institutet.
    Ekstedt, Mirjam
    Linnaeus University, Faculty of Health and Life Sciences, Department of Health and Caring Sciences. Karolinska Institutet.
    Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing?2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, p. 1-7, article id 82Article in journal (Refereed)
    Abstract [en]

    BackgroundDespite worldwide interest in reducing re-hospitalization, there is limited knowledge regarding characteristics of patients who chose to decline participation in such efforts and why. The aim is to explore reasons to decline participation in an intervention using motivational interviewing to reduce re-hospitalization through patient activation for persons with chronic obstructive pulmonary disease or heart failure.MethodsThis study uses data from 385 patients who were asked about participating in a randomized controlled trial; of these, 232 declined participation. Data on age, gender, and diagnosis were collected for those who agreed to participate and those who declined. Reasons to decline participation were collected for those who were asked to participate but refused. The stated reasons to decline were analyzed using content analysis, and the categories identified were used for the statistical analysis.ResultsThe main reasons for declining participation were having sufficient support (17.5%), no need for support (16%), being too ill (14.6%), and lack of time for illness-related activities (14.2%). A statistically significant negative association between age and willingness to participate was found (odds ratio=-0.03, 95% confidence interval 0.95-0.99).ConclusionsThose who agreed to participate were younger than non-participants, and non-participants either lacked time for illness-related activities or did not have the energy needed to become involved in the intervention.Trial registrationClinicalTrials.gov, NCT02823795. Registered on 1 July 2016.

  • 26. Forsell, Yvonne
    et al.
    Hallgren, Mats
    Mattson, Maria
    Ekblom, Örjan
    Swedish School of Sport and Health Sciences, GIH, Department of Sport and Health Sciences, Åstrand Laboratory of Work Physiology, Björn Ekblom's and Mats Börjesson's research group.
    Lavebratt, Catharina
    FitForLife: study protocol for a randomized controlled trial.2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, no 1, article id 553Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Psychosis is a serious mental illness that typically emerges during early adulthood. The disorder is characterized by inactivity, cognitive deficits and the need for ongoing support. Regular exercise has mood enhancing and anxiolytic effects that could benefit this patient group. To date, few studies have examined the effects of prescribed exercise on autonomy, health and cognitive functioning in psychosis.

    METHODS/DESIGN: This is a single-center, randomized controlled trial (RCT) with a 3-month follow-up. Usual care plus a 12-week supervised exercise program will be compared to usual outpatient care alone. The primary outcome will be patient autonomy measured by the Camberwell Assessment of Need (CAN) schedule - clinician rated. Secondary outcomes include cardiovascular risk factors, cognitive functioning, substance abuse, body awareness, depression and mood state. Changes in inflammatory markers and microbiotica will be explored. The feasibility of using patients as exercise trainers will also be assessed.

    DISCUSSION: The treatment potential for exercise in psychosis is large because most individuals with the disorder are young and inactive. The study is one of the first to comprehensively assess the effects of regular exercise in young adults with psychosis. Sessions will be closely supervised and adjusted to meet patient needs. Both the feasibility and treatment effects of exercise interventions in psychosis will be discussed.

    TRIAL REGISTRATION: German Clinical Trials Register DRKS00008991 7 August 2015.

  • 27.
    Frykholm, Erik
    et al.
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation.
    Klijn, Peter
    Saey, Didier
    van Hees, Hieronymus W. H.
    Stål, Per
    Umeå University, Faculty of Medicine, Department of Integrative Medical Biology (IMB).
    Sandström, Thomas
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Sörlin, Ann
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation.
    Maltais, François
    Nyberg, Andre
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation.
    Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 6Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: In people with chronic obstructive pulmonary disease (COPD), limb-muscle dysfunction is one of the most troublesome systemic manifestations of the disease, which at the functional level is evidenced by reduced strength and endurance of limb muscles. Improving limb-muscle function is an important therapeutic goal of COPD management, for which resistance training is recommended. However, current guidelines for resistance training in COPD mainly focus on improving muscle strength which only reflects one aspect of limb-muscle function and does not address the issue of reduced muscle endurance. The latter is of importance considering that the reduction in limb-muscle endurance often is greater than that of muscle weakness, and also, limb-muscle endurance seems to be closer related to walking capacity as well as arm function than to limb-muscle strength within this group of people. Thus, strategies targeting multiple aspects of the decreased muscle function are warranted to increase the possibility for an optimal effect for the individual patient. Periodized resistance training, which represents a planned variation of resistance training variables (i.e., volume, intensity, frequency, etc.), is one strategy that could be used to target limb-muscle strength as well as limb-muscle endurance within the same exercise regimen.

    METHODS: This is an international, multicenter, randomized controlled trial comparing the effect and feasibility of non-linear periodized resistance training to traditional non-periodized resistance training in people with COPD. Primary outcomes are dynamic limb-muscle strength and endurance. Secondary outcomes include static limb-muscle strength and endurance, functional performance, quality of life, dyspnea, intramuscular adaptations as well as the proportion of responders. Feasibility of the training programs will be assessed and compared on attendance rate, duration, satisfaction, drop-outs as well as occurrence and severity of any adverse events.

    DISCUSSION: The proposed trial will provide new knowledge to this research area by investigating and comparing the feasibility and effects of non-linear periodized resistance training compared to traditional non-periodized resistance training. If the former strategy produces larger physiological adaptations than non-periodized resistance training, this project may influence the prescription of resistance training in people with COPD.

    TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03518723 . Registered on 13 April 2018.

  • 28.
    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, ISSN 1745-6215, 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.

  • 29.
    Gonzalez, Manuel
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Cardiology. Commonwealth Scientific Research and Industrial Organisation (CSIRO), Brisbane, Australia.
    Sjölin, Ingela
    Bäck, Maria
    Ögmundsdottir Michelsen, Halldora
    Tanha, Tina
    Sandberg, Camilla
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Cardiology. Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Physiotherapy.
    Schiopu, Alexandru
    Leosdottir, Margret
    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, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 76Article in journal (Refereed)
    Abstract [en]

    Background: Cardiac 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/design: An 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 < 75 years 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 4 weeks after discharge and when the patient has completed his/her exercise program at the CR center, usually around 3–6 months 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.

    Discussion: The present study will add evidence to whether electronic communication can be used to improve traditional CR programs for patients after MI.

  • 30. Graham, C.
    et al.
    Lewis, S.
    Forbes, J.
    Mead, G.
    Hackett, M. L.
    Hankey, G. J.
    Gommans, J.
    Nguyen, H. T.
    Lundström, E.
    Isaksson, E.
    Näsman, Per
    KTH.
    Rudberg, A. -S
    Dennis, M.
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: Statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 627Article in journal (Refereed)
    Abstract [en]

    Background: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. Methods/Design: The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. Discussion: Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020.

  • 31. Graham, Catriona
    et al.
    Lewis, Steff
    Forbes, John
    Mead, Gillian
    Hackett, Maree L
    Hankey, Graeme J
    Gommans, John
    Nguyen, Huy Thang
    Lundström, Erik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology. Karolinska Inst, Dept Clin Neurosci Neurol, Stockholm, Sweden.
    Isaksson, Eva
    Näsman, Per
    Rudberg, Ann-Sofie
    Dennis, Martin
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis.2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 627Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome.

    METHODS/DESIGN: The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months.

    DISCUSSION: Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020.

    TRIAL REGISTRATION: FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012.

    AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011.

    EFFECTS: ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.

  • 32.
    Haas, Josephine
    et al.
    Karolinska Institutet Institutionen för klinisk forskning och utbildning Södersjukhuset.
    Persson, Martina
    stitutionen för klinisk forskning och utbildning Södersjukhuset.
    Brorsson, Anna Lena
    stitutionen för klinisk forskning och utbildning Södersjukhuset.
    Toft, Eva Hagström
    Olinder, Anna Lindholm
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical diabetology and metabolism. Department of Clinical Science and Education, Karolinska Institute; Sachs’ Children and Youth Hospital, Södersjukhuset, Stockholm.
    Guided self-determination-young versus standard care in the treatment of young females with type 1 diabetes: study protocol for a multicentre randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 562Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Female adolescents with type 1 diabetes mellitus (T1DM) have the most unsatisfactory glycaemic control of all age groups and report higher disease burden, poorer perceived health, and lower quality of life than their male counterparts. Females with T1DM face an excess risk of all-cause mortality compared with men with T1DM. New methods are needed to help and support young females with T1DM to manage their disease. A prerequisite for successful diabetes management is to offer individualized, person-centred care and support the patient's own motivation. Guided self-determination (GSD) is a person-centred reflection and problem-solving method intended to support the patient's own motivation in the daily care of her diabetes and help develop skills to manage difficulties in diabetes self-management. GSD has been shown to improve glycaemic control and decrease psychosocial stress in young women with T1DM. The method has been adapted for adolescents and their parents, termed GSD-young (GSD-Y). The aim of this study was to evaluate whether an intervention with GSD-Y in female adolescents with T1DM leads to improved glycaemic control, self-management, treatment satisfaction, perceived health and quality of life, fewer diabetes-related family conflicts, and improved psychosocial self-efficacy.

    METHODS/DESIGN: This is a parallel-group randomized controlled superiority trial with an allocation ratio of 1:1. One hundred female adolescents with T1DM, 15-20 years of age, and their parents (if < 18 years of age), will be included. The intervention group will receive seven individual GSD-Y education visits over 3 to 6 months. The control group will receive standard care including regular visits to the diabetes clinic. The primary outcome is level of glycaemic control, measured as glycosylated haemoglobin (HbA1c). Secondary outcomes include diabetes self-management, treatment satisfaction, perceived health and quality of life, diabetes-related family conflicts, and psychosocial self-efficacy. Data will be collected before randomization and at 6 and 12 months.

    DISCUSSION: Poor glycaemic control is common in female adolescents and young adults with T1DM. Long-standing hyperglycaemia increases the risks for severe complications and may also have an adverse impact on the outcome of future pregnancies. In this study, we want to evaluate if the GSD-Y method can be a useful tool in the treatment of female adolescents with T1DM.

    TRIAL REGISTRATION: Current controlled trials, ISRCTN57528404 . Registered on 18 February 2015.

  • 33. Haas, Josephine
    et al.
    Persson, Martina
    Brorsson, Anna Lena
    Karolinska institutet.
    Toft, Eva Hagström
    Olinder, Anna Lindholm
    Guided self-determination-young versus standard care in the treatment of young females with type 1 diabetes: study protocol for a multicentre randomized controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 562Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Female adolescents with type 1 diabetes mellitus (T1DM) have the most unsatisfactory glycaemic control of all age groups and report higher disease burden, poorer perceived health, and lower quality of life than their male counterparts. Females with T1DM face an excess risk of all-cause mortality compared with men with T1DM. New methods are needed to help and support young females with T1DM to manage their disease. A prerequisite for successful diabetes management is to offer individualized, person-centred care and support the patient's own motivation. Guided self-determination (GSD) is a person-centred reflection and problem-solving method intended to support the patient's own motivation in the daily care of her diabetes and help develop skills to manage difficulties in diabetes self-management. GSD has been shown to improve glycaemic control and decrease psychosocial stress in young women with T1DM. The method has been adapted for adolescents and their parents, termed GSD-young (GSD-Y). The aim of this study was to evaluate whether an intervention with GSD-Y in female adolescents with T1DM leads to improved glycaemic control, self-management, treatment satisfaction, perceived health and quality of life, fewer diabetes-related family conflicts, and improved psychosocial self-efficacy.

    METHODS/DESIGN: This is a parallel-group randomized controlled superiority trial with an allocation ratio of 1:1. One hundred female adolescents with T1DM, 15-20 years of age, and their parents (if < 18 years of age), will be included. The intervention group will receive seven individual GSD-Y education visits over 3 to 6 months. The control group will receive standard care including regular visits to the diabetes clinic. The primary outcome is level of glycaemic control, measured as glycosylated haemoglobin (HbA1c). Secondary outcomes include diabetes self-management, treatment satisfaction, perceived health and quality of life, diabetes-related family conflicts, and psychosocial self-efficacy. Data will be collected before randomization and at 6 and 12 months.

    DISCUSSION: Poor glycaemic control is common in female adolescents and young adults with T1DM. Long-standing hyperglycaemia increases the risks for severe complications and may also have an adverse impact on the outcome of future pregnancies. In this study, we want to evaluate if the GSD-Y method can be a useful tool in the treatment of female adolescents with T1DM.

    TRIAL REGISTRATION: Current controlled trials, ISRCTN57528404 . Registered on 18 February 2015.

  • 34.
    Hallgren, Mats
    et al.
    Karolinska institutet.
    Andersson, Victoria
    Center for Psychiatric Research, Stockholm.
    Ekblom, Örjan
    Swedish School of Sport and Health Sciences, GIH, Department of Sport and Health Sciences, Åstrand Laboratory of Work Physiology, Björn Ekblom's research group.
    Andréasson, Sven
    Karolinska institutet.
    Physical activity as treatment for alcohol use disorders (FitForChange): study protocol for a randomized controlled trial.2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, no 1, article id 106Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Help-seeking for alcohol use disorders (AUDs) is low and traditional treatments are often perceived as stigmatizing. Physical activity has positive effects on mental and physical health which could benefit this population. We propose to compare the effects of aerobic training, yoga, and usual care for AUDs in physically inactive Swedish adults.

    METHODS: This is a three-group, parallel, single-blind, randomized controlled trial (RCT). In total, 210 adults (aged 18-75 years) diagnosed with an AUD will be invited to participate in a 12-week intervention. The primary study outcome is alcohol consumption measure by the Timeline Follow-back method and the Alcohol Use Disorders Identification Test (AUDIT). Secondary outcomes include: depression, anxiety, perceived stress, sleep quality, physical activity levels, fitness, self-efficacy, health-related quality of life, and cognition. Blood samples will be taken to objectively assess heavy drinking, and saliva to measure cortisol. Acute effects of exercise on the urge to drink alcohol, mood, and anxiety will also be assessed.

    DISCUSSION: The treatment potential for exercise in AUDs is substantial as many individuals with the disorder are physically inactive and have comorbid health problems. The study is the first to assess the effects of physical activity as a stand-alone treatment for AUDs. Considerable attention will be given to optimizing exercise adherence. Both the feasibility and treatment effects of exercise interventions in AUDs will be discussed. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (DNR: 2017/1380-3).

    TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00012311. Registered on 26 September 2017.

  • 35.
    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, ISSN 1745-6215, 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.

  • 36. Howick, Jeremy
    et al.
    Mebius, Alexander
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    In search of justification for the unpredictability paradox2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, no 480Article in journal (Refereed)
    Abstract [en]

    A 2011 Cochrane Review found that adequately randomized trials sometimes revealed larger, sometimes smaller, and often similar effect sizes to inadequately randomized trials. However, they found no average statistically significant difference in effect sizes between the two study types. Yet instead of concluding that adequate randomization had no effect the review authors postulated the "unpredictability paradox", which states that randomized and non-randomized studies differ, but in an unpredictable direction. However, stipulating the unpredictability paradox is problematic for several reasons: 1) it makes the authors' conclusion that adequate randomization makes a difference unfalsifiable-if it turned out that adequately randomized trials had significantly different average results from inadequately randomized trials the authors could have pooled the results and concluded that adequate randomization protected against bias; 2) it leaves other authors of reviews with similar results confused about whether or not to pool results (and hence which conclusions to draw); 3) it discourages researchers from investigating the conditions under which adequate randomization over- or under-exaggerates apparent treatment benefits; and 4) it could obscure the relative importance of allocation concealment and blinding which may be more important than adequate randomization.

  • 37.
    Huber, Daniel
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Henriksson, Robin
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Jakobsson, Stina
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Stenfors, Nikolai
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Pulmonary Medicine.
    Mooe, Thomas
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Implementation of a telephone-based secondary preventive intervention after acute coronary syndrome (ACS): participation rate, reasons for non-participation and 1-year survival2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, article id 85Article in journal (Refereed)
    Abstract [en]

    Background: Acute coronary syndrome (ACS) is a major cause of death from a non-communicable disease. Secondary prevention is effective for reducing morbidity and mortality, but evidence-based targets are seldom reached and new interventional methods are needed. The present study is a feasibility study of a telephone-based secondary preventive programme in an unselected ACS cohort. Methods: The NAILED (Nurse-based Age-independent Intervention to Limit Evolution of Disease) ACS trial is a prospective randomized controlled trial. All eligible patients admitted for ACS were randomized to usual follow-up by a general practitioner or telephone follow-up by study nurses. The intervention was made by continuous telephone contact, with counseling on healthy living and titration of medicines to reach target values for blood pressure and blood lipids. Exclusion criteria were limited to physical inability to follow the study design or participation in another study. Results: A total of 907 patients were assessed for inclusion. Of these, 661 (72.9 %) were included and randomized, 100 (11 %) declined participation, and 146 (16.1 %) were excluded. The main reasons for exclusion were participation in another trial, dementia, and advanced disease. "Excluded" and "declining" patients were significantly older with more co-morbidity, decreased functional status, and had more seldom received education above compulsory school level than "included" patients. Non-participants had a higher 1-year mortality than participants. Conclusions: Nurse-led telephone-based follow-up after ACS can be applied to a large proportion in an unselected clinical setting. Reasons for non-participation, which were associated with increased mortality, include older age, multiple co-morbidities, decreased functional status and low level of education.

  • 38. Hyttel-Sorensen, Simon
    et al.
    Austin, Topun
    van Bel, Frank
    Benders, Manon
    Claris, Olivier
    Dempsey, Eugene
    Fumagalli, Monica
    Greisen, Gorm
    Grevstad, Berit
    Hagmann, Cornelia
    Hellström-Westas, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Pediatrics.
    Lemmers, Petra
    Lindschou, Jane
    Naulaers, Gunnar
    van Oeveren, Wim
    Pellicer, Adelina
    Pichler, Gerhard
    Roll, Claudia
    Skoog, Maria
    Winkel, Per
    Wolf, Martin
    Gluud, Christian
    A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, p. 120-Article in journal (Refereed)
    Abstract [en]

    Background: Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO(2). Methods/Design: SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO(2) values outside the target ranges of 55% to 85%, that is, the 'burden of hypoxia and hyperoxia' expressed in '%hours'. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion: Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia.

  • 39.
    Idahl, Annika
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Obstetrics and Gynecology.
    Darelius, Anna
    Sundfeldt, Karin
    Palsson, Mathias
    Strandell, Annika
    Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 10Article in journal (Refereed)
    Abstract [en]

    Background

    There is a great need for a prospective randomized trial to evaluate the risks and benefits of opportunistic salpingectomy. Recently, genetic and morphologic studies have indicated that epithelial ovarian cancer predominantly develops in the Fallopian tubes. Consequently, there is reason to believe that salpingectomy would reduce the risk of ovarian cancer. Studies on reducing the risk of ovarian cancer have compared indicated salpingectomy with no salpingectomy, while studies on surgical safety as well as ovarian function after opportunistic salpingectomy have been small with a short follow-up. No study has reported menopausal symptoms.

    Methods/design

    In this national register-based randomized controlled trial, women <55 years old, planned for a hysterectomy for a benign cause, will be randomized to concomitant salpingectomy or no salpingectomy. The follow-up will be conducted according to already established routines within the register using on-line questionnaires. Primary outcomes have been defined for three different time points: short-term complications up to 8 weeks postoperatively (n = 2800), intermediate-term changes in menopausal symptoms measured by the Menopause Rating Scale at baseline and after 1 year (n = 1670), and long-term epithelial ovarian cancer assessed through national registers after 30 years (n = 5052) (or n = 7001 for high-grade serous cancer). In a sub-study of 75 women, ovarian function will be evaluated through change in anti-Müllerian hormone measured before surgery and after 1 year.

    Discussion

    Hysterectomy for a benign cause is a common surgical procedure and several national societies recommend salpingectomy while performing a benign hysterectomy, despite a lack of scientific evidence for the safety of the procedure. Sweden has unique conditions for clinical trials because of its national quality registers and health registers with excellent quality and near complete coverage. If no additional risks are associated with concomitant salpingectomy, it can be recommended at the time of benign hysterectomy to reduce the risk of epithelial ovarian cancer. If not, the risks and benefits must be balanced. The results of this study will be important for informing women undergoing a benign hysterectomy.

    Trial registration

    ClinicalTrials.gov, NCT03045965. Registered on 8 February 2017

  • 40.
    Irewall, Anna-Lotta
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Ögren, Joachim
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Bergström, Lisa
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Laurell, Katarina
    Umeå University, Faculty of Medicine, Department of Pharmacology and Clinical Neuroscience, Clinical Neuroscience.
    Söderström, Lars
    Unit of Research, Development and Education, Region Jämtland Härjedalen, Östersund Hospital, Östersund, Sweden.
    Mooe, Thomas
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Nurse-led, telephone-based secondary preventive follow-up benefits stroke/TIA patients with low education: a randomized controlled trial sub-study2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 52Article in journal (Refereed)
    Abstract [en]

    Background: The objective of this study was to analyze the impact of two forms of secondary preventive followup on the association between education level and levels of blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) after stroke/transient ischemic attack (TIA).

    Methods: We included a population-based cohort of 771 stroke and TIA patients randomly assigned (1:1) to secondary preventive follow-up within primary health care (control) or nurse-led, telephone-based follow-up (intervention) between January 1, 2010, and December 31, 2013, as part of the NAILED (nurse-based ageindependent intervention to limit evolution of disease) stroke risk factor trial. We compared BP and LDL-C levels 12 months after hospital discharge in relation to education level (low, ≤10 years; high, >10 years) separately for the intervention and control groups.

    Results: Among controls, systolic BP (SBP) decreased only among the highly educated (−2.5 mm Hg, 95% confidence interval (CI) −0.2 to −4.8), whereas LDL-C increased in the low-education group (0.2 mmol/L, 95% CI 0.1 to 0.3). At 12 months, controls with low education not more than 70 years of age had higher SBP than controls of the same age with high education (5.8 mm Hg, 95% CI 1.0 to 10.6). In contrast, SBP in the intervention group decreased similarly regardless of education level, LDL-C decreased among those with low education (−0.3 mmol/L, 95% CI −0.2 to −0.4) and, in the subgroup not more than 70 years old, low-educated participants had lower LDL-C at 12 months than those with high education (0.3 mmol/L, 95% CI 0.1 to 0.5).

    Conclusions: Nurse-led, telephone-based secondary preventive follow-up led to comparable improvements in BP across education groups, while routine follow-up disfavored those with low education.

    Trial registration: ISRCTN Registry ISRCTN23868518, June 19, 2012 - Retrospectively registered

  • 41.
    Isaksson, Eva
    et al.
    Karolinska Inst, Dept Clin Neurosci, Neurol, Nobels Vag 6, SE-17176 Stockholm, Sweden.
    Wester, Per
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden;Umea Univ, Dept Publ Hlth & Clin Med, S-90187 Umea, Sweden.
    Laska, Ann Charlotte
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden.
    Nasman, Per
    KTH Royal Inst Technol, Ctr Safety Res, SE-10044 Stockholm, Sweden.
    Lundström, Erik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Landtblom: Neurology.
    Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 618Article in journal (Refereed)
    Abstract [en]

    Background:

    Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT.

    Methods:

    We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively.

    Results:

    Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%).

    Conclusions:

    For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

  • 42. Isaksson, Eva
    et al.
    Wester, Per
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine. Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-18288 Stockholm, Sweden.
    Laska, Ann Charlotte
    Näsman, Per
    Lundström, Erik
    Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 618Article in journal (Refereed)
    Abstract [en]

    Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT.

    Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named “What is Important for Making a Study Successful questionnaire” (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively.

    Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%).

    Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

  • 43.
    Isaksson, Eva
    et al.
    Karolinska Inst, Dept Clin Neurosci, Neurol, Nobels Vag 6, SE-17176 Stockholm, Sweden..
    Wester, Per
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden.;Umea Univ, Dept Publ Hlth & Clin Med, S-90187 Umea, Sweden..
    Laska, Ann Charlotte
    Danderyd Hosp, Karolinska Inst, Dept Clin Sci, SE-18288 Stockholm, Sweden..
    Näsman, Per
    KTH, School of Architecture and the Built Environment (ABE), Real Estate and Construction Management, Building and Real Estate Economics. Center for Safety Research.
    Lundström, Erik
    Uppsala Univ, Dept Clin Neurosci, Neurol, SE-75185 Uppsala, Sweden..
    Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no 1, article id 618Article in journal (Refereed)
    Abstract [en]

    Background: Many randomised controlled trials (RCT) fail to meet their recruitment goals. Study personnel play a key role in recruitment. The aim of this study was to identify successful strategies that study personnel consider to be important in patient recruitment to RCT. Methods: We constructed a questionnaire based on the literature, discussions with colleagues and our own experience as trialists. The survey was named "What is Important for Making a Study Successful questionnaire" (WIMSS-q). Our target group was the study personnel in the ongoing EFFECTS study. The questionnaire was sent out electronically to all physicians and nurses (n = 148). Success factors and barriers were divided according to patient, centre and study level, respectively. Results: Responses were received from 94% of the study personnel (139/148). The five most important factors at centre level for enhancing recruitment were that the research question was important (97%), a simple procedure for providing information and gaining consent (92%), a highly engaged local principal investigator and research nurse (both 87%), and that study-related follow-ups are practically feasible and possible to coordinate with the clinical follow-up (87%). The most significant barrier at the local centre was lack of time and resources devoted to research (72%). Important patient-related barriers were fear of side effects (35%) and language problems (30%). Conclusions: For recruitment in an RCT to be successful, the research question must be relevant, and the protocol must be simple and easy to implement in the daily routine.

  • 44.
    Juszczak, Edmund
    et al.
    National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
    Kwakkenbos, Linda
    Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, The Netherlands.
    McCall, Stephen
    National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
    Imran, Mahrukh
    Lady Davis Institue for Medical Research, Jewish General Hospital, Montreal, Canada.
    Hemkens, Lars G.
    Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
    Zwarenstein, Merrick
    Depts of Family Medicine and Epidemiology/Biostatistics, Western University, London, Canada.
    Fröbert, Ole
    Örebro University, School of Medical Sciences.
    Relton, Clare
    Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.
    Sampson, Margaret
    CHEO, Ottawa, Canada.
    Thabane, Chair Lehana
    Biostatistics Unit (St Joseph's Healthcare)/FSORC, Hamilton, Canada.
    Benchimol, Eric I.
    Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
    Campbell, Marion K.
    University of Aberdeen, Aberdeen, United Kingdom.
    Torgerson, David J.
    University of York, York, United Kingdom.
    Erlinge, David
    Department of Cardiology, Lund University, Skane University Hospital, Lund, Sweden.
    Rice, Danielle B.
    McGill University, Montreal, Canada.
    Langan, Sinead
    London School of Hygiene and Tropical Medicine, London, United Kingdom.
    Mc Cord, Kimberly A.
    Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
    van Staa, Tjeerd P.
    University of Manchester, Manchester, United Kingdom.
    Moher, David
    Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
    Verkooijen, Helena M.
    University Medical Center Utrecht, Utrecht, the Netherlands.
    Uher, Rudolf
    Dalhousie Unversity, Department of Psychiatry, Halifax, Canada.
    Worron-Sauve, Maureen B.
    Scleroderma Canada, Hamilton, Canada.
    Boutron, Isabelle
    Université de Paris, Paris, France.
    Ravaud, Philippe
    Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS-UMR1153), Paris, France.
    Thombs, Brett D.
    Lady Davis Institue for Medical Research, Jewish General Hospital, Montreal, Canada.
    Gale, Chris
    Imperial College London, London, United Kingdom.
    Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, no Suppl. 1, p. 131-131, article id PS9A - O4Article in journal (Other academic)
    Abstract [en]

    Background: Randomised controlled trials (RCTs) are increasingly being conducted using existing sources of data, such as cohorts, administrative databases, disease registries and electronic health records. RCTs conducted using existing data sources require additional information to be reported. This reporting guideline is an extension of the 2010 version of the Consolidated Standards of Reporting Trials (CONSORT) Statement for RCTs using cohorts and routinely collected health data.

    Methods: A long-list of potential items for the checklist was identified through two methods: firstly, modifications to the current CONSORT checklist were generated using existing reporting guidelines, including the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Secondly, ascoping review of RCTs conducted in the last decade using cohorts and routinely collected health data facilitated the modification and identification of other potential items. Using the long-list, a three-stage Delphi exercise was conducted to assess the importance of each item for inclusion in the final extension checklist, which was finalised at a face-to-face meeting of experts.

    Results: A long-list of 27 items was created and 125 experts registered for the three-round Delphi exercise (92, 77 and 62 experts participated in each round respectively). Consensus was reached on 21 out of 27 items. The results of the Delphi exercise informed a face-to-face consensus meeting in May 2019; core items to be included in the extension checklist were finalised at this meeting. Corresponding explanations of extensions and new items with examples of good reporting were developed subsequently.

    Conclusion: The guideline checklist can facilitate transparent reporting of RCTs using cohorts and routinely collected health data, to assist evaluations of rigour and reproducibility, enhance understanding of the methodology, and make the results more useful for clinicians, journal editors, reviewers, guideline authors, and funders.

  • 45.
    Karlsson, Jan Olof
    et al.
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    Jynge, Per
    Linköping University, Department of Medical and Health Sciences. Linköping University, Faculty of Medicine and Health Sciences.
    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, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 380Article in journal (Other academic)
    Abstract [en]

    n/a

  • 46.
    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, ISSN 1745-6215, 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.

  • 47.
    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, ISSN 1745-6215, 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.

  • 48.
    Lechner, Anna
    et al.
    Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin Berlin, Berlin, Germany.
    Kottner, Jan
    Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité – Universitätsmedizin Berlin, Berlin, Germany; University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium.
    Coleman, Susanne
    Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
    Muir, Delia
    Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
    Bagley, Heather
    Clinical Trials Research Centre (CTRC), North West Hub for Trials Methodology, University of Liverpool, Liverpool, UK.
    Beeckman, Dimitri
    Örebro University, School of Health Sciences. University Centre for Nursing and Midwifery, Ghent University, Ghent, Belgium; School of Health Sciences, Nursing and Midwifery, University of Surrey, Guildford, UK; School of Nursing and Midwifery, Royal College of Surgeons in Ireland, Dublin, Ireland.
    Chaboyer, Wendy
    School of Nursing & Midwifery, Menzies Health Institute Queensland, Griffith University and Gold Coast Hospital and Health Service, Southport Qld, Australia.
    Cuddigan, Janet
    College of Nursing, University of Nebraska Medical Center, Omaha NE, USA.
    Moore, Zena
    Royal College of Surgeons in Ireland, Dublin, Ireland; Monash University, Melbourne, Australia; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium; Lida Institute, Shanghai, China; Cardiff University, Cardiff, Wales.
    Rutherford, Claudia
    Faculty of Science, Quality of Life Office, School of Psychology, University of Sydney, Sydney, Australia; Sydney Nursing School, Cancer Nursing Research Unit (CNRU), University of Sydney, Sydney, Australia.
    Schmitt, Jochen
    Centre for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
    Nixon, Jane
    Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.
    Balzer, Katrin
    Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK; Institute for Social Medicine and Epidemiology, Nursing Research Unit, University of Lübeck, Lübeck, Germany.
    Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions2019In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, article id 449Article in journal (Refereed)
    Abstract [en]

    Background: Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS.

    Methods/design: The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders.

    Discussion: After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups.

    Trial registration: The OUTPUTs project is registered in the COMET database: (http://www.comet-initiative.org/studies/details/283). Registered on 2015.

  • 49.
    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, ISSN 1745-6215, 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.

  • 50.
    Lindner, Philip
    et al.
    Karolinska Institutet.
    Ivanova, Ekaterina
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    Ly, Kien Hoa
    Linköping University.
    Andersson, Gerhard
    Linköping University.
    Carlbring, Per
    Stockholm University, Faculty of Social Sciences, Department of Psychology.
    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, ISSN 1745-6215, 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 36months) 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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