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  • 1.
    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, 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.

  • 2.
    Bergh, Cecilia
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Landberg, Rikard
    Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Gothenburg, Sweden; Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Andersson, Kristina
    Department of Experimental Medical Science, Lund University, Lund, Sweden; Glucanova AB, Lund, Sweden.
    Heyman-Lindén, Lovisa
    Molecular Nutrition, Department of Experimental Medical Science, Lund University, Lund, Sweden; Berry Lab AB, Lund, Sweden.
    Rascón, Ana
    Glucanova AB, Lund, Sweden; Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.
    Magnuson, Anders
    School of Medical Sciences, Örebro University, Örebro, Sweden.
    Khalili, Payam
    Department of Cardiology and Acute Internal Medicine, Central Hospital, Karlstad, Sweden.
    Kåregren, Amra
    Department of Medicine, Hospital Region Västmanland, Västerås, Sweden.
    Nilsson, Johan
    Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Pirazzi, Carlo
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology.
    Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 338Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Bilberries from Sweden, rich in polyphenols, have shown cholesterol-lowering effects in small studies, and the cholesterol-lowering properties of oats, with abundant beta-glucans and potentially bioactive phytochemicals, are well established. Both may provide cardiometabolic benefits following acute myocardial infarction (AMI), but large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects. No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors. Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry or with bioprocessed oat bran, with a secondary explorative objective of assessing their combination, compared with a neutral isocaloric reference supplement, initiated within 5 days following percutaneous coronary intervention (PCI) for AMI.

    METHODS: The effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI) trial is a double-blind, randomized, placebo-controlled clinical trial. A total of 900 patients will be randomized post-PCI to one of four dietary intervention arms. After randomization, subjects will receive beverages with bilberry powder (active), beverages with high-fiber bioprocessed oat bran (active), beverages with bilberry and oats combined (active), or reference beverages containing no active bilberry or active oats, for consumption twice daily during a 3-month intervention. The primary endpoint is the difference in LDL cholesterol change between the intervention groups after 3 months. The major secondary endpoint is exercise capacity at 3 months. Other secondary endpoints include plasma concentrations of biochemical markers of inflammation, metabolomics, and gut microbiota composition after 3 months.

    DISCUSSION: Controlling hyperlipidemia and inflammation is critical to preventing new cardiovascular events, but novel pharmacological treatments for these conditions are expensive and associated with negative side effects. If bilberry and/or oat, in addition to standard medical therapy, can lower LDL cholesterol and inflammation more than standard therapy alone, this could be a cost-effective and safe dietary strategy for secondary prevention after AMI.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03620266 . Registered on August 8, 2018.

  • 3.
    Bergman Nordgren, Lise
    et al.
    Linköping University, Linköping, Sweden.
    Andersson, Gerhard
    Karolinska Institutet, Stockholm, Sweden; Linköping University, Linköping, Sweden.
    Kadowaki, Åsa
    County council of Östergötland, Linköping, Sweden.
    Carlbring, Per
    Umeå University, Umeå, Sweden.
    Tailored internet-administered treatment of anxiety disorders for primary care patients: Study protocol for a randomised controlled trial2012In: Trials, E-ISSN 1745-6215, Vol. 13, no 1, article id 16Article in journal (Refereed)
    Abstract [en]

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

  • 4.
    Holmefur, Marie
    et al.
    Örebro University, School of Health Sciences.
    Roshanay, Afsaneh
    Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
    White, Suzanne
    State University of New York, Downstate Medical Center, Brooklyn, New York, USA.
    Janeslätt, Gunnel
    Department of Public Health and Caring Sciences, Uppsala University and Centre for Clinical Research in Dalarna, Uppsala University, Falun, Sweden.
    Vimefall, Elin
    Örebro University, Örebro University School of Business.
    Lidström-Holmqvist, Kajsa
    Örebro University, School of Health Sciences. Örebro University Hospital. University Health Care Research Center.
    Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 640Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead to poor occupational balance, low self-efficacy, and poor parental sense of competence. "Let's Get Organized" (LGO) is a recently developed manual-based group intervention to train time management skills. The aim of this trial is to evaluate the efficiency of the Swedish version of LGO (LGO-S) compared to treatment as usual (individual occupational therapy) to improve time management for adults with impaired time management skills due to mental or neurodevelopmental disorders. Furthermore, to evaluate if the intervention is a cost-effective way to improve the quality of life and time management skills of these individuals, we will conduct a health economic evaluation.

    METHODS: The trial will have a multi-centre, open, parallel randomised controlled design. A total of 104 adults with cognitive limitations due to mental or neurodevelopmental disorders will be recruited from open psychiatric or habilitation care units. Outcomes will be measured before and after a 10-week intervention, with a follow-up 3 months after completing the intervention. The primary outcome will be self-assessed time management skills. Secondary outcomes will be e.g. self-assessed skills in organisation and planning, regulation of emotions, satisfaction with daily occupations, occupational balance, self-efficacy, and quality-adjusted life years.

    DISCUSSION: A recent feasibility study has shown promising results for LGO-S, and a randomised trial will provide robust evidence for the possible efficacy of LGO-S in comparison to treatment as usual.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03654248 . Registered on 20 August 2018.

  • 5.
    Holy, Marek
    et al.
    Örebro University, School of Medical Sciences. Department of Orthopedic Surgery.
    MacDowall, Anna
    Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
    Sigmundsson, Freyr Gauti
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Orthopedic Surgery.
    Olerud, Class
    Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
    Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy2021In: Trials, E-ISSN 1745-6215, Vol. 22, no 1, article id 607Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50-55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The controversy is in the choice of operative treatment, conducting either anterior cervical decompression and fusion or posterior foraminotomy. The study objective is to evaluate short- and long-term outcome of anterior cervical decompression and fusion (ACDF) and posterior foraminotomy (PF)

    METHODS: A multicenter prospective randomized controlled trial with 1:1 randomization, ACDF vs. PF including 110 patients. The primary aim is to evaluate if PF is non-inferior to ACDF using a non-inferiority design with ACDF as "active control." The neck disability index (NDI) is the primary outcome measure, and duration of follow-up is 2 years.

    DISCUSSION: Due to absence of high level of evidence, the authors believe that a RCT will improve the evidence for using the different surgical treatments for cervical radiculopathy and strengthen current surgical treatment recommendation.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT04177849. Registered on November 26, 2019.

  • 6.
    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, 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.

  • 7.
    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, 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.

  • 8.
    Lundqvist, Stefan
    et al.
    Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Centrum för fysisk aktivitet Göteborg, Gothenburg, Region Västra Götaland, Sweden.
    Börjesson, Mats
    Center for Health and Performance (CHP), University of Gothenburg, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Sahlgrenska University Hospital/Östra, Gothenburg, Region Västra Götaland, Sweden.
    Cider, Åsa
    Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Hagberg, Lars
    Örebro University, School of Health Sciences. Örebro University Hospital. University Health Care Research Center.
    Ottehall, Camilla Bylin
    Centrum för fysisk aktivitet Göteborg, Gothenburg, Region Västra Götaland, Sweden.
    Sjöström, Johan
    Centrum för fysisk aktivitet Göteborg, Gothenburg, Region Västra Götaland, Sweden.
    Larsson, Maria E. H.
    Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Research and Development Primary Health Care, Gothenburg, Region Västra Götaland, Sweden.
    Long-term physical activity on prescription intervention for patients with insufficient physical activity level: a randomized controlled trial2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 793Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Physical activity (PA) can be used to prevent and treat diseases. In Sweden, licensed healthcare professionals use PA on prescription (PAP) to support patients to increase their PA level. The aim of this randomized controlled trial was to evaluate a 2-year intervention of two different strategies of PAP treatment for patients with insufficient PA level, after a previous 6-month period of ordinary PAP treatment in a primary health care setting.

    METHODS: We included 190 patients, 27-77 years, physically inactive with metabolic risk factors where the patients were not responding to a previous 6-month PAP treatment with increased PA. The patients were randomized to either enhanced support from a physiotherapist (PT group) or continued ordinary PAP treatment at the health care centre (HCC group). The PAP treatment included an individualized dialogue; an individually dosed PA recommendation, including a written prescription; and a structured follow-up. In addition to PAP, the PT group received aerobic fitness tests and more frequent scheduled follow-ups. The patient PA level, metabolic health, and health-related quality of life (HRQOL) were measured at baseline and at 1- and 2-year follow-ups.

    RESULTS: At the 2-year follow-up, 62.9% of the PT group and 50.8% of the HCC group had increased their PA level and 31.4% vs. 38.5% achieved ≥ 150 min of moderate-intensity PA/week (difference between groups n.s.). Over 2 years, both groups displayed increased high-density lipoproteins (HDL) (p = 0.004 vs. baseline), increased mental health status (MCS) (p = 0.036), and reduced body mass index (BMI) (p = 0.001), with no difference between groups.

    CONCLUSION: During long-term PAP interventions, the PA level, metabolic health, and HRQOL increased in patients at metabolic risk without significant differences between groups. The results indicate to be independent of any changes in pharmacological treatment. We demonstrated that the PAP treatment was feasible in ordinary primary care. Both the patients and the healthcare system benefitted from the improvement in metabolic risk factors. Future studies should elucidate effective long-term PAP-treatment strategies.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT03012516 . Registered on 30 December 2016-retrospectively registered.

  • 9.
    Olsson, Anneli
    et al.
    Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
    Ring, Camilla
    Department of Cardiology, Norrland University Hospital, Umeå, Sweden.
    Josefsson, Johan
    Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden.
    Eriksson, Annika
    Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden.
    Rylance, Rebecca
    Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden.
    James, Stefan
    Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
    Sparv, David
    Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
    Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 246Article in journal (Refereed)
    Abstract [en]

    Objective: We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents in patients undergoing coronary intervention. A witnessed oral IC was required prior to randomization in patients with ST-segment elevation myocardial infarction, which was subsequently complemented with a written IC after percutaneous coronary intervention. Written consent was obtained before angiography in patients with non-ST-segment elevation myocardial infarction.

    Background: The IC process in patients with AMI is under debate. Earlier trials in this population have required prospective consent before randomization. A trial published some years ago used deferred consent, but the patient experience of this process is poorly studied.

    Methods: A total of 414 patients who participated in the main trial were enrolled and asked the following questions: (1) Do you remember being asked to participate in a study? (2) How was your experience of being asked to participate; do you remember it being positive or negative? (3) Would you have liked more information about the study? (4) Do you think it would have been better if you were included in the study without being informed until a later time?

    Results: Of these patients, 94% remembered being included; 85% of them experienced this positively, 12% were neutral and 3% negative. Regarding more information, 88% did not want further information, and 68% expressed that they wanted to be consulted before inclusion. Of the patients, 5% thought it would have been better to have study inclusion without consent, and 27% considered it of no importance.

    Conclusion: It is reasonable to ask patients for verbal IC in the acute phase of AMI. Most patients felt positively about being asked to participate and had knowledge of being enrolled in a scientific study. In addition they objected to providing IC after randomization and treatment.

  • 10.
    Relton, Clare
    et al.
    Queen Mary University of London, London, United Kingdom.
    Nickolls, Beverley
    Queen Mary University of London, London, United Kingdom.
    Zwarenstein, Merrick
    Department of Family Medicine, Epidemiology & Biostatistics, University of Western Ontario, London, Canada.
    Hemken, Lars G.
    Basel Institute for Clinical Epidemiology and Biostatistics , Basel, Switzerland.
    Uher, Rudolf
    Dalhousie University, Department of Psychiatry, Halifax, Canada.
    Fröbert, Ole
    Örebro University, School of Medical Sciences.
    Fibert, Philippa
    ScHARR, University of Sheffield, Sheffield, UK.
    Imran, Mahukh
    Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Canada.
    Kwakkenbos, Linda
    Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands.
    Thombs, Brett D.
    McGill University and Jewish General Hospital, Montreal, Canada.
    Review of use of the Trials within Cohorts (TwiCs) design approach2019In: Trials, E-ISSN 1745-6215, Vol. 20, no Suppl. 1, p. 112-113, article id PS5A - O3Article in journal (Other academic)
    Abstract [en]

    Introduction: Trials within Cohorts (TwiCs) is an innovative approach to the design and conduct of multiple randomised controlled trials (RCTs) (Relton et al, 2010). This approach utilises an observational cohort to recruit trial populations and obtain short and longer term outcomes. We describe what is currently known about the use of this design approach.

    Methods: An extension of the 2010 Consolidated Standards of Reporting Trials (CONSORT) Statements for RCTs using cohorts and/or routinely collected health data is in development, supported by a scoping review that includes publications of methods or reports ofprotocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources for this scoping review included Medline and Cochrane Methodology Register and were limited to English language.

    This review of use of the TwiCs approach uses publications of methods or reports of protocols or results from RCTs that use cohorts to recruit identified in the scoping review. This is supplemented with information from topic experts.

    We report: (i) types of cohorts (setting, population, condition/ disease area), (ii) how the cohorts are utilised (identifying potential trial participants, recruitment, randomisation, process and outcome data collection including bespoke and/or routine health record data, types of trials conducted/ planned), (iii) approaches to informed consent, e.g. staged approach (Young-Afat et al, 2016), and (iv) any purported and/or real study design (in)efficiencies.

    Timing of Potential Results: Early results indicate 75+ eligible full text articles, including 23 trial protocols and 23 articles reporting the results of trials using cohorts. Full results will be available in August 2019 and presented at the conference.

    Potential Relevance and Impact: Standard approaches to trial design are often costly and frequently fail to recruit sufficiently large or representative samples. This review will help provide information on the use and potential (in)efficiency of the TwiCs approach

  • 11.
    Relton, Clare
    et al.
    Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.
    Zwarenstein, Merrick
    Western University, Toronto, Canada.
    Hemkens, Lars G.
    Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
    Verkooijen, Helena M.
    University Medical Centre Utrecht, Utrecht, The Netherlands.
    Fröbert, Ole
    Örebro University, School of Medical Sciences.
    Health System Trials2019In: Trials, E-ISSN 1745-6215, Vol. 20, p. 115-115Article in journal (Other academic)
    Abstract [en]

    Pragmatic randomised trials aim to provide evidence to support decisions by stakeholders in healthcare systems (patients, clinicians, funders, policy makers). The typical pragmatic trial recruits participantwho provide data for the trial using purpose built data collection systems. At the end of the trial–all is disbanded. This approach is costland frequently fails to recruit sufficiently large or representativsamples.

    Since the advent of electronic data, pragmatic trials are increasingly using routine health data collected from administrative, clinical and patient sources. A new group of trial designs have emerged which we describe as ‘Health System Trials’. These include Registry-based Randomised Controlled Trials (RRCTs), Electronic Health Record (EHR) Trials, Administrative Data (AD) Trials and Trials within Cohorts (TwiCs). These four designs purposefully utilise existing and/or newly created health system data structures for one or more trial activities: identifying potential trial participants, recruitment, randomisation, process and outcome data collection, etc. The process of informed consent is often spread out (staged) as occurs in routine healthcare especially with TwiCs designs.

    By utilising populations within health systems and the data that derives from their healthcare encounters, these trials efficiently recruit large representative populations and obtain both short and longerterm outcomes. These designs reduce the effort and cost of trials whilst improving the applicability of the trial results for decision makers in health systems.

    We discuss the opportunities for these types of trial designs to be integrated within health systems, enabling the continuous generation of knowledge that is an essential feature of learning health systems. CONSORT Reporting guidelines for Trials Using Cohorts and Routine Health Data are currently being developed. Drawing on development work for these guidelines we describe real world examples of ‘HealthSystem Trials’, including examples of both nascent vertical (disease focused) and horizontal (e.g. practice based) learning health systems.

  • 12.
    Sundh, Josefin
    et al.
    Örebro University, School of Medical Sciences. Department of Respiratory Medicine.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, United Kingdom.
    Andell, Pontus
    Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Heart and Vascular Division, Karolinska University Hospital, Stockholm, Sweden.
    Rindler, Gustaf
    Lekeberg Primary Health Care Centre, Örebro, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology.
    Przybyszewska, Malgorzata
    Blomberg, Anders
    Widmark, Magnus
    Palm, Andreas
    Greger, Wolfgang
    Ellingsen, Jens
    Rahlen, Lennart
    Kipper, Taivo
    Hasselgren, Mikael
    Smith, Carolina
    Delijaj, Florim
    Possler, Kaj
    Nilsson, Johanna
    Stenersen, Niklas
    Curiac, Dan
    Vanfleteren, Lowie E. G. W.
    Johansson, Lars
    Sjöberg, Folke
    Ekström, Magnus
    Berglund, Johan Sanmartin
    Lokke, Anders
    Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized controlled trial2020In: Trials, E-ISSN 1745-6215, Vol. 21, no 1, article id 123Article in journal (Refereed)
    Abstract [en]

    Background: Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascular disease, but data from randomized controlled trials (RCT) are lacking. The aim of this RCT is to investigate whether beta-blocker therapy in patients with COPD without diagnosed cardiovascular disease is associated with a decreased 1-year risk of the composite endpoint of death, exacerbations, or cardiovascular events.

    Methods: The Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is an open-label, multicentre, prospective RCT. A total of 1700 patients with COPD will be randomly assigned to either standard COPD care and metoprolol at a target dose of 100 mg per day or to standard COPD care only. The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events. Major exclusion criteria are ischemic heart disease, left-sided heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter. Study visits are an inclusion visit, a metoprolol titration visit at 1 month, follow-up by telephone at 6 months, and a final study visit after 1 year. Outcome data are obtained from medical history and record review during study visits, as well as from national registries.

    Discussion: BRONCHIOLE is a pragmatic randomized trial addressing the potential of beta-blockers in patients with COPD. The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.

  • 13.
    Syrjälä, M. B.
    et al.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Bennet, L.
    Department of Clinical Sciences, Lund University, Malmö, Sweden; Center for Primary Health Care Research, Region Skåne and Lund University, Malmö, Sweden; Clinical Research and Trial Center, Lund University Hospital, Lund, Sweden.
    Dempsey, P. C.
    Baker Heart and Diabetes Institute, Melbourne, Australia; MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.
    Fharm, E.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Hellgren, M.
    Skaraborg Institute, Skövde, Sweden.
    Jansson, Stefan P. O.
    Örebro University, School of Medical Sciences. Örebro University Hospital. School of Medical Sciences, University Health Care Research Center, Örebro University, Örebro, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
    Nilsson, S.
    Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
    Nordendahl, M.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Rolandsson, O.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Rådholm, K.
    Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
    Ugarph-Morawski, A.
    Academic Primary Care Center, Region Stockholm, Stockholm, Sweden; Department of Neurobiology, Care Sciences, and Society, Division of Family Medicine and Primary Care, The Karolinska Institute, Huddinge, Sweden.
    Wändell, P.
    Department of Neurobiology, Care Sciences, and Society, Division of Family Medicine and Primary Care, The Karolinska Institute, Huddinge, Sweden.
    Wennberg, P.
    Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.
    Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial-the ROSEBUD study2022In: Trials, E-ISSN 1745-6215, Vol. 23, no 1, article id 607Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM.

    METHODS: A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides.

    DISCUSSION: Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.

    TRIAL REGISTRATION: ClinicalTrials.gov NCT04219800 . Registered on 7 January 2020.

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