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  • 1. 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).

  • 2. 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.

  • 3.
    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.

  • 4.
    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.

  • 5.
    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.

  • 6.
    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

  • 7.
    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

  • 8. Lundström, Erik
    et al.
    Isaksson, Eva
    Wester, Per
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Section of Medicine. Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Laska, Ann-Charlotte
    Näsman, Per
    Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 14Article in journal (Refereed)
    Abstract [en]

    Background: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.

    Methods: ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n=27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.

    Discussion: EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.

  • 9.
    Mooe, Thomas
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Bergstrom, Lisa
    Irewall, Anna-Lotta
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Medicine.
    Ögren, Joachim
    The NAILED stroke risk factor trial (Nurse based Age independent Intervention to Limit Evolution of Disease after stroke): study protocol for a randomized controlled trial2013In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 14, p. 5-Article in journal (Refereed)
    Abstract [en]

    Background: Secondary prevention after stroke and transient ischemic attack (TIA) is essential in order to reduce morbidity and mortality. Secondary stroke prevention studies have, however, been fairly small, or performed as clinical trials with non-representative patient selection. Long-term follow-up data is also limited. A nurse-led follow-up for risk factor improvement may be effective but the evidence is limited. The aims of this study are to perform an adequately sized, nurse-led, long-term secondary preventive follow-up with a population-based inclusion of stroke and TIA patients. The focus will be on blood pressure and lipid control as well as tobacco use and physical activity. Methods: A randomized, controlled, long-term, population-based trial with two parallel groups. The patients will be included during the initial hospital stay. Important outcome variables are sitting systolic and diastolic blood pressure, LDL cholesterol and total cholesterol. Outcomes will be measured after 12, 24 and 36 months of follow-up. Trained nurses will manage the intervention group with a focus on reaching set treatment goals as soon as possible. The control group will receive usual care. At least 200 patients will be included in each group, in order to reliably detect a difference in mean systolic blood pressure of 5 mmHg. This sample size is also adequate for detection of clinically meaningful group differences in the other outcomes. Discussion: This study will test the hypothesis that a nurse-led, long-term follow-up after stroke with a focus on reaching set treatment goals as soon as possible, is an effective secondary preventive method. If proven effective, this method could be implemented in general practice at a low cost.

  • 10.
    Nyberg, Andre
    et al.
    Umeå University, Faculty of Medicine, Department of Community Medicine and Rehabilitation, Physiotherapy.
    Saey, Didier
    Martin, Mickaël
    Maltais, François
    Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 194Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Low-load, high-repetitive single-limb resistance training may increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while minimizing the occurrence of limiting exertional symptoms. Whether high-repetitive single-limb resistance training would perform better than high-repetitive two-limb resistance training is unknown. In addition, the mechanisms underlying possible benefits of high-repetitive resistance training has not been investigated. The aims of this study are to compare single versus two-limb high-repetitive resistance training in patients with COPD and to investigate mechanisms of action of these training modalities.

    METHODS/DESIGN: This trial is a prospective, assessor-blind, randomized controlled trial. The participants are patients with stable severe to very severe COPD who are older than 40 years of age and healthy controls. The intervention is single-limb, high-repetitive, resistance training with elastic bands, three times/week for 8 weeks. The control is two-limb high-repetitive resistance training with elastic bands, three times/week for 8 weeks. The primary outcomes is change in the 6-min walking distance after 8 weeks of single-limb or two-limb high-repetitive resistance training. The secondary outcomes are changes in limb muscle strength and endurance capacity, key protein involved in quadriceps anabolic/catabolic signalization, fiber-type distribution and capillarization, subjective dyspnea and muscle fatigue, muscle oxygenation, cardiorespiratory demand and health-related quality-of-life after 8 weeks of single-limb or two-limb high-repetitive resistance training. The acute effects of single-limb versus two-limb high-repetitive resistance training on contractile fatigue, exercise stimulus (the product of number of repetition and load), subjective dyspnea and muscle fatigue, muscle oxygenation, and cardiorespiratory demand during upper and lower limb exercises will also be investigated in patients with COPD and healthy controls. Randomization will be performed using a random number generator by a person independent of the recruitment process, using 1:1 allocation to the intervention and the control group using random block sizes. Blinding: All outcome assessors will be blinded to group assignment.

    DISCUSSION: The results of this project will provide important information to help developing and implementing customized exercise training programs for patients with COPD.

    TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02283580 Registration date: 4 November 2014. First participant randomized: 10 November 2014.

  • 11.
    Olofsson, Roger
    et al.
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Surg, S-41345 Gothenburg, Sweden.
    Ny, Lars
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Oncol, S-41345 Gothenburg, Sweden.
    All-Ericsson, Charlotta
    St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden.
    Sternby Eilard, Malin Sternby
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden.
    Rizell, Magnus
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden.
    Cahlin, Christian
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden.
    Stierner, Ulrika
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Dept Oncol, S-41345 Gothenburg, Sweden.
    Lönn, Ulf
    Linköping Univ Hosp, Dept Oncol, S-58185 Linköping, Sweden.
    Hansson, Johan
    Ljuslinder, Ingrid
    Umeå University, Faculty of Medicine, Department of Radiation Sciences, Oncology.
    Lundgren, Lotta
    Skåne Univ Hosp, Dept Oncol, S-22185 Lund, Sweden.
    Ullenhag, Gustav
    Uppsala Univ, Dept Radiol Oncol & Radiat Sci, Sect Oncol, S-75105 Uppsala, Sweden.
    Kiilgaard, Jens Folke
    Univ Copenhagen, Glostrup Hosp, Dept Ophthalmol, DK-2600 Glostrup, Denmark.
    Nilsson, Jonas
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Sahlgrenska Canc Ctr, S-40530 Gothenburg, Sweden.
    Lindnér, Per
    Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Clin Sci,Tranplant Inst, S-41345 Gothenburg, Sweden.
    Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, p. 317-Article in journal (Refereed)
    Abstract [en]

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

  • 12.
    Thorogood, Margaret
    et al.
    Univ Warwick, Warwick Med Sch, Div Hlth Sci, Coventry CV4 7AL, W Midlands, England.
    Goudge, Jane
    Univ Witwatersrand, Sch Publ Hlth, Ctr Hlth Policy, Fac Hlth Sci, ZA-2193 Johannesburg, South Africa.
    Bertram, Melanie
    WHO, CH-1211 Geneva 27, Switzerland.
    Chirwa, Tobias
    Univ Witwatersrand, Sch Publ Hlth, Div Epidemiol & Biostat, Fac Hlth Sci, ZA-2193 Johannesburg, South Africa.
    Eldridge, Sandra
    Queen Mary Univ London, London E1 4NS, England.
    Gomez-Olive, Francesc Xavier
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Univ Witwatersrand, Fac Hlth Sci, Sch Publ Hlth, MRC Wits Rural Publ Hlth & Hlth Transit Res Unit, ZA-2193 Johannesburg, South Africa.
    Limbani, Felix
    Univ Witwatersrand, Fac Hlth Sci, Sch Publ Hlth, MRC Wits Rural Publ Hlth & Hlth Transit Res Unit, ZA-2193 Johannesburg, South Africa.
    Musenge, Eustasius
    Univ Witwatersrand, Sch Publ Hlth, Div Epidemiol & Biostat, Fac Hlth Sci, ZA-2193 Johannesburg, South Africa.
    Myakayaka, Nokuzola
    Univ Witwatersrand, Fac Hlth Sci, Sch Publ Hlth, MRC Wits Rural Publ Hlth & Hlth Transit Res Unit, ZA-2193 Johannesburg, South Africa.
    Tollman, Stephen
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Univ Witwatersrand, Fac Hlth Sci, Sch Publ Hlth, MRC Wits Rural Publ Hlth & Hlth Transit Res Unit, ZA-2193 Johannesburg, South Africa.
    Twine, Rhian
    Univ Witwatersrand, Fac Hlth Sci, Sch Publ Hlth, MRC Wits Rural Publ Hlth & Hlth Transit Res Unit, ZA-2193 Johannesburg, South Africa.
    The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial2014In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 15, p. 435-Article in journal (Refereed)
    Abstract [en]

    Background: South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension.

    Methods/Design: The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation.

    Discussion: There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations.

  • 13.
    Wilder-Smith, Annelies
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. Heidelberg Univ, Sch Med, Inst Publ Hlth, Heidelberg, Germany.
    Byass, Peter
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Olanratmanee, Phanthip
    Maskhao, Pongsri
    Sringernyuang, Luechai
    Logan, James G.
    Lindsay, Steve W.
    Banks, Sarah
    Gubler, Duane
    Louis, Valerie R.
    Tozan, Yesim
    Kittayapong, Pattamaporn
    The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand2012In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 13, article id 212Article in journal (Refereed)
    Abstract [en]

    Background: There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence.

    Methods: A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons.

    Discussion: Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed.

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