uu.seUppsala University Publications
Change search
Refine search result
1 - 24 of 24
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Rows per page
  • 5
  • 10
  • 20
  • 50
  • 100
  • 250
Sort
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
Select
The maximal number of hits you can export is 250. When you want to export more records please use the Create feeds function.
  • 1.
    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.

  • 2.
    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.

  • 3. 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)
  • 4.
    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.

  • 5.
    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.

  • 6.
    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.

  • 7.
    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.

  • 8. 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.

  • 9. 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.

  • 10.
    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.

  • 11. 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.

  • 12.
    Lipcsey, Miklós
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Hedenstierna laboratory.
    Tenhunen, Jyrki
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care.
    Sjölin, Jan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Infectious Diseases.
    Frithiof, Robert
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care.
    Bendel, Stepani
    Kuopio Univ Hosp, Dept Intens Care, Kuopio, Finland..
    Flaatten, Hans
    UiB, Haukeland Univ Hosp, Dept Clin Med, Bergen, Norway..
    Kawati, Rafael
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care.
    Kuitunen, Anne
    Tampere Univ Hosp, Crit Care Med Res Grp, POB 200033521, Tampere, Finland..
    Tonnessen, Tor Inge
    Oslo Univ Hosp, Div Emergencies & Crit Care, N-0450 Oslo, Norway.;Inst Clin Med, N-0450 Oslo, Norway..
    Rubertsson, Sten
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care.
    Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - endotoxin removal in abdominal and urogenital septic shock with the Alteco (R) LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, article id 587Article in journal (Refereed)
    Abstract [en]

    Background: Severe sepsis and septic shock are common in intensive care and carry high mortality rates. In patients with Gram-negative infections, early and extensive removal of endotoxin may limit the inflammatory response that characterizes septic shock. The Alteco (R) LPS Adsorber (hereafter referred to cited as the lipopolysaccharide (LPS) Adsorber) can be used for endotoxin removal and attenuate the deleterious inflammatory and clinical responses seen in septic shock. Methods/design: The Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) trial is a pilot study investigating the feasibility and safety of LPS Adsorber therapy. This pilot, multicenter, stratified, parallel, double-blinded, randomized, phase IIa, feasibility clinical investigation will be performed in five Scandinavian intensive care units. Thirty-two subjects with early septic shock and organ failure, following adequate resuscitation, will be randomized to receive either: extracorporeal veno-venous hemoperfusion therapy with the LPS Adsorber or veno-venous hemoperfusion therapy with a placebo adsorber (without active LPS-binding peptide). Patients will be stratified by infection focus such that 20 subjects with an abdominal focus (stratum A) and 12 subjects with a urogenital focus (stratum B) will be included in a parallel design. Thereafter, an interim analysis will be performed and an additional 12 patients may be included in the study. The study is designed as adaptive a priori: the patients from this study can be included in a later phase IIb study. The aim of the study is to investigate the feasibility of LPS Adsorber therapy commenced early in the time-course of septic shock. The primary endpoint will be a characterization of all reported unanticipated serious adverse device effects and anticipated serious adverse device effects. Secondary outcomes are decrease in endotoxin plasma concentration, impact on clinical outcome measures and impact on inflammatory response by LPS Adsorber therapy, as well as detailed description of the relevant mediators bound to the LPS Adsorber. Recruitment of patients will start in September 2015. Discussion: The ASSET trial will give insight into the feasibility and safety of this LPS Adsorber therapy and preliminary data on its potential clinical effects in septic shock. Moreover, this pilot trial will provide with necessary data for designing future studies.

  • 13.
    Lundström, E
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology. Karolinska University Hospital, Stockholm, Sweden.
    Isaksson, Eva
    Wester, Per
    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 trial.2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, no 1, 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.

    TRIAL REGISTRATIONS: The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.

  • 14. Mead, Gillian
    et al.
    Hackett, Maree L
    Lundström, E
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurology. Karolinska Univ Hosp, Dept Neurol, Solna, Sweden.
    Murray, Veronica
    Hankey, Graeme J
    Dennis, Martin
    The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials.2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 369Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome.

    METHODS/DESIGN: The three trial investigator teams have collaboratively developed a core protocol. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (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 subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients. The trials include patients ≥18 years old with a clinical diagnosis of stroke, persisting focal neurological deficits at randomisation between 2 and 15 days after stroke onset. Patients are randomised centrally via web-based randomisation systems using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Our primary outcome measure is the modified Rankin scale (mRS) at 6 months. Secondary outcomes include the Stroke Impact Scale, EuroQol (EQ5D-5 L), the vitality subscale of the Short-Form 36, diagnosis of depression, adherence to medication, adverse events and resource use. Outcomes are collected at 6 and 12 months. The methods of collecting these data are tailored to the national setting. If FOCUS, AFFINITY and EFFECTS combined enrol 6000 participants as planned, they would have 90 % power (alpha 5 %) to detect a common odds ratio of 1.16, equivalent to a 3.7 % absolute difference in percentage with mRS 0-2 (44.0 % to 47.7 %). This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm.

    DISCUSSION: If fluoxetine is safe and effective in promoting functional recovery, it could be rapidly, widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke.

    TRIAL REGISTRATION:

    FOCUS: ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011).

    EFFECTS: ISRCTN13020412 (19/12/2014).

  • 15.
    Norlund, Fredrika
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
    Olsson, Erik M. G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
    Burell, Gunilla
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Wallin, Emma
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Clinical Psychology in Healthcare.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial2015In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 16, article id 154Article in journal (Refereed)
    Abstract [en]

    Background: Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI. Methods/design: This is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment. Discussion: The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care.

  • 16.
    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
    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
    Linkoping Univ Hosp, Dept Oncol, S-58185 Linkoping, Sweden.
    Hansson, Johan
    Karolinska Univ Hosp, Dept Oncol, S-17176 Stockholm, Sweden.
    Ljuslinder, Ingrid
    Norrlands Univ Hosp, Dept Oncol, S-90185 Umea, Sweden.
    Lundgren, Lotta
    Skane Univ Hosp, Dept Oncol, S-22185 Lund, Sweden.
    Ullenhag, Gustav
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
    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, article id 317Article in journal (Refereed)
    Abstract [en]

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

  • 17.
    Raaben, Marco
    et al.
    Univ Med Ctr Utrecht, Dept Surg, Heidelberglaan 100, NL-3508 GA Utrecht, Netherlands.
    Mohd Shah, Syaiful Redzwan
    Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Solid State Electronics.
    Augustine, Robin
    Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Solid State Electronics.
    Blokhuis, Taco Johan
    Maastricht Univ, Med Ctr, Dept Surg, P Debyelaan 25, NL-6229 HX Maastricht, Netherlands.
    COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 220Article in journal (Refereed)
    Abstract [en]

    Background:

    Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly.

    Methods:

    This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age >= 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group.

    Discussion:

    The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible.

  • 18.
    Robinson, Anna-Lena
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics. Stockholm Spine Ctr, Stockholm, Sweden;Lowenstromska Hosp, Stockholm Spine Ctr, S-19489 Stockholm, Upplands Vasby, Sweden.
    Schmeiser, Gregor
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics. Schon Clin Hamburg Eilbek, Hamburg, Germany.
    Robinson, Yohan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics. Armed Forces Ctr Def Med, Dept Res & Dev, Gothenburg, Sweden.
    Olerud, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Orthopaedics.
    Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial2018In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 452Article in journal (Refereed)
    Abstract [en]

    Background: Displaced odontoid fractures in the elderly are treated non-surgically with a cervical collar or surgically with C1-C2 fusion. Due to the paucity of evidence, the treatment decision is often left to the discretion of the expert surgeon.

    Methods: The Uppsala Study on Odontoid Fracture Treatment (USOFT) is a multicentre, open-label, randomised controlled superiority trial evaluating the clinical superiority of the surgical treatment of type-2 odontoid fractures, with a 1-year Neck Disability Index (NDI) as the primary endpoint. Fifty consecutive patients aged >= 75 years, with displaced type-2 odontoid fracture, are randomised to non-surgical or surgical treatment. Excluded are patients with an American Society of Anaesthesiologists (ASA) score >= 4, dementia nursing care or anatomical cervical anomalies. The minimal clinically important difference of the NDI is 3.5 points. A minimum of 16 patients are needed in each group to test the superiority with 80% power. By considering a 1-year mortality forecast of 29%, up to 25 participants are recruited in each group. The non-surgical group is fitted with a rigid cervical collar for 12 weeks. The surgical group is treated with a posterior C1-C2 fusion. All participants are monitored with regard to the NDI, EuroQol score (EQ-5D), socio-demographics and computed tomography (CT) at the time of injury, at 6 weeks, 3 months and 12 months. At 12 months, a dynamic radiographical investigation of upper cervical stability is performed. The secondary endpoints are: EQ-5D score, activities of daily living (ADL), bony union, upper cervical stability and mortality.

    Discussion: USOFT is the first randomised controlled trial comparing non-surgical and surgical management of type-2 odontoid fractures in the elderly. Using the NDI and EQ-5D as endpoints, future value-based decisions may consider quality-adjusted life years gained. Major limitations are (1) the allocation bias of the open-label study design, (2) that only higher training levels of all core specialties of spine surgery are included in the surgical treatment arm and (3) that only one type of surgical stabilisation is investigated (posterior C1-C2 fusion), while other methods are not included in this study.

  • 19.
    Sandelowsky, Hanna
    et al.
    Karolinska Inst, NVS, Div Family Med & Primary Care, Alfred Nobels Alle 23,D2, S-14183 Stockholm, Sweden..
    Krakau, Ingvar
    Karolinska Inst, NVS, Div Family Med & Primary Care, Alfred Nobels Alle 23,D2, S-14183 Stockholm, Sweden..
    Modin, Sonja
    Karolinska Inst, NVS, Div Family Med & Primary Care, Alfred Nobels Alle 23,D2, S-14183 Stockholm, Sweden..
    Ställberg, Björn
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Nager, Anna
    Karolinska Inst, NVS, Div Family Med & Primary Care, Alfred Nobels Alle 23,D2, S-14183 Stockholm, Sweden..
    Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, article id 197Article in journal (Refereed)
    Abstract [en]

    Background: Chronic obstructive pulmonary disease (COPD) is a common cause of morbidity and mortality worldwide. It is often undiagnosed and insufficiently managed. Effective forms of continuing medical education (CME) for primary care physicians (PCPs) are necessary to ensure the implementation of guidelines in clinical practice and, thus, improve patients' health.

    Methods: In this study, we will measure the effects of CME by Case Method and compare them against those of traditional lectures and no CME at all through an unblinded, cluster randomised controlled trial (CRCT). Thirty-three primary health care centres (PHCCs) in Stockholm, Sweden, with a total of 180 PCPs will be involved. Twenty-two primary PHCCs, will be cluster-randomised into: an intervention group who will receive CME by Case Method (n = 11) and a control group who will receive traditional lectures (n = 11). The remaining PHCCs (n = 11) will be a reference group and will receive no CME. From the intervention and control groups, 460 randomly selected patients with COPD in GOLD stages 2 and 3 will participate, while no patients will be recruited from the reference group.

    For the patients, smoking status, actual treatment and urgent visits to a health provider due to airway problems will be registered. For the PCPs, professional competence (i.e. knowledge and management skills) in COPD, will be measured using a questionnaire based on current guidelines and guideline implementation problems in clinical practice which has previously been described by the authors. Data will be collected at baseline and at follow-up, which will be after 1.5 years for the patients, and 1 year for the PCPs. Statistical methods for individual-level and cluster-level analyses will be used.

    Discussion: COPD is considered a particularly complex clinical challenge involving managing multimorbidity, symptom adaptation, and lifestyle problematisation. Case Method in CME for PCPs may contribute to a better understanding of the impact of COPD on patients' lives and, thus, improve their management of it. The present study is expected to contribute scientific knowledge about indicators for an effective CME in COPD that is tailor-made to primary care physicians.

  • 20.
    Villar, Jesus
    et al.
    Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ Dr Negrin, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Res Unit, Barranco Ballena S-N,4th Floor South Wing, Las Palmas Gran Canaria 35019, Spain.;St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr Biomed Sci, 30 Bond St, Toronto, ON M5B 1W8, Canada..
    Belda, Javier
    Hosp Clin Univ Valencia, Dept Anesthesiol, Avda Blasco Ibanez 17, Valencia 46010, Spain..
    Blanco, Jesus
    Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ Rio Hortega, Intens Care Unit, Calle Dulzaina 2, Valladolid 47012, Spain..
    Suarez-Sipmann, Fernando
    Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Univ Uppsala Hosp, Hedenstierna Lab, Dept Surg Sci, Akad Sjukhuset, Ing 40,Tr 3, SE-75185 Uppsala, Sweden..
    Manuel Anon, Jose
    Hosp Virgen de La Luz, Intens Care Unit, Hermandad de Donantes Sangre S-N, Cuenca 16002, Spain..
    Perez-Mendez, Lina
    Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ NS Candelaria, Res Unit, Div Clin Epidemiol & Biostat, Carretera Gen Rosario 145, Santa Cruz De Tenerife 38010, Spain..
    Ferrando, Carlos
    Hosp Clin Univ Valencia, Dept Anesthesiol, Avda Blasco Ibanez 17, Valencia 46010, Spain..
    Parrilla, Dacil
    Hosp Univ NS Candelaria, Intens Care Unit, Carretera Gen Rosario 145, Santa Cruz De Tenerife 38010, Spain..
    Montiel, Raquel
    Hosp Univ NS Candelaria, Intens Care Unit, Carretera Gen Rosario 145, Santa Cruz De Tenerife 38010, Spain..
    Corpas, Ruth
    Hosp Gen NS Prado, Intens Care Unit, Carretera Madrid,Km 114, Talavera De La Reina, Toledo, Spain..
    Gonzalez-Higueras, Elena
    Hosp Virgen de La Luz, Intens Care Unit, Hermandad de Donantes Sangre S-N, Cuenca 16002, Spain..
    Pestana, David
    Hosp Univ Ramon y Cajal, Dept Anesthesiol, Carretera Colmenar Viejo,Km 9,100, Madrid 28034, Spain..
    Martinez, Domingo
    Hosp Univ Virgen de la Arrixaca, Intens Care Unit, Carretera Madrid Cartagena S-N, Murcia 30120, Spain..
    Fernandez, Lorena
    Soro, Marina
    Hosp Clin Univ Valencia, Dept Anesthesiol, Avda Blasco Ibanez 17, Valencia 46010, Spain..
    Angel Garcia-Bello, Miguel
    Hosp Univ Dr Negrin, Div Biostat, Res Unit, Barranco Ballena S-N, Las Palmas Gran Canaria 35019, Spain..
    Lidia Fernandez, Rosa
    Inst Salud Carlos III, CIBER Enfermedades Resp, Monforte de Lemos 3-5,Pabellon 11, Madrid 28029, Spain.;Hosp Univ Dr Negrin, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Res Unit, Barranco Ballena S-N,4th Floor South Wing, Las Palmas Gran Canaria 35019, Spain..
    Kacmarek, Robert M.
    Massachusetts Gen Hosp, Dept Resp Care, 55 Fruit St, Boston, MA 02114 USA.;Harvard Univ, Dept Anesthesiol, 55 Fruit St Gray Bigelow 444, Boston, MA 02144 USA..
    Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, article id 500Article in journal (Refereed)
    Abstract [en]

    Background: Patient-ventilator asynchrony is a common problem in mechanically ventilated patients with acute respiratory failure. It is assumed that asynchronies worsen lung function and prolong the duration of mechanical ventilation (MV). Neurally Adjusted Ventilatory Assist (NAVA) is a novel approach to MV based on neural respiratory center output that is able to trigger, cycle, and regulate the ventilatory cycle. We hypothesized that the use of NAVA compared to conventional lung-protective MV will result in a reduction of the duration of MV. It is further hypothesized that NAVA compared to conventional lung-protective MV will result in a decrease in the length of ICU and hospital stay, and mortality. Methods/design: This is a prospective, multicenter, randomized controlled trial in 306 mechanically ventilated patients with acute respiratory failure from several etiologies. Only patients ventilated for less than 5 days, and who are expected to require prolonged MV for an additional 72 h or more and are able to breathe spontaneously, will be considered for enrollment. Eligible patients will be randomly allocated to two ventilatory arms: (1) conventional lung-protective MV (n = 153) and conventional lung-protective MV with NAVA (n = 153). Primary outcome is the number of ventilator-free days, defined as days alive and free from MV at day 28 after endotracheal intubation. Secondary outcomes are total length of MV, and ICU and hospital mortality. Discussion: This is the first randomized clinical trial examining, on a multicenter scale, the beneficial effects of NAVA in reducing the dependency on MV of patients with acute respiratory failure.

  • 21.
    Waiswa, Peter
    et al.
    School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
    O'Connell, Thomas
    Economics and Finance, UNICEF NewYork, Three UN Plaza, New York, USA.
    Bagenda, Danstan
    School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
    Mullachery, Pricila
    UNICEF NewYork, Three UN Plaza, New York, USA.
    Mpanga, Flavia
    Health Section, UNICEF Uganda Country Office, Kampala, Uganda.
    Henriksson, Dorcus Kiwanuka
    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).
    Katahoire, Anne Ruhweza
    Child Health and Development Centre, Makerere University, Kampala, Uganda.
    Ssegujja, Eric
    School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
    Mbonye, Anthony K
    School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
    Peterson, Stefan Swartling
    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).
    Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, article id 135Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Innovative and sustainable strategies to strengthen districts and other sub-national health systems and management are urgently required to reduce child mortality. Although highly effective evidence-based and affordable child survival interventions are well-known, at the district level, lack of data, motivation, analytic and planning capacity often impedes prioritization and management weaknesses impede implementation. The Community and District Empowerment for Scale-up (CODES) project is a complex management intervention designed to test whether districts when empowered with data and management tools can prioritize and implement evidence-based child survival interventions equitably.

    METHODS: The CODES strategy combines management, diagnostic, and evaluation tools to identify and analyze the causes of bottlenecks to implementation, build capacity of district management teams to implement context-specific solutions, and to foster community monitoring and social accountability to increase demand for services. CODES combines UNICEF tools designed to systematize priority setting, allocation of resources and problem solving with Community dialogues based on Citizen Report Cards and U-Reports used to engage and empower communities in monitoring health service provision and to demand for quality services. Implementation and all data collection will be by the districts teams or local Community-based Organizations who will be supported by two local implementing partners. The study will be evaluated as a cluster randomized trial with eight intervention and eight comparison districts over a period of 3 years. Evaluation will focus on differences in uptake of child survival interventions and will follow an intention-to-treat analysis. We will also document and analyze experiences in implementation including changes in management practices.

    DISCUSSION: By increasing the District Health Management Teams' capacity to prioritize and implement context-specific solutions, and empowering communities to become active partners in service delivery, coverage of child survival interventions will increase. Lessons learned on strengthening district-level managerial capacities and mechanisms for community monitoring may have implications, not only in Uganda but also in other similar settings, especially with regard to accelerating effective coverage of key child survival interventions using locally available resources.

  • 22. Waiswa, Peter
    et al.
    Peterson, Stefan S.
    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).
    Namazzi, Gertrude
    Ekirapa, Elizabeth Kiracho
    Naikoba, Sarah
    Byaruhanga, Romano
    Kiguli, Juliet
    Kallander, Karin
    Tagoola, Abner
    Nakakeeto, Margaret
    Pariyo, George
    The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial2012In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 13, p. 213-Article in journal (Refereed)
    Abstract [en]

    Background: Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Methods/Design: Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas. The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during pregnancy and the neonatal period. Both areas benefit from a standardized strengthening of facility care for mothers and neonates. (Continued on next page) Discussion: UNEST is designed to directly feed into the operationalization of maternal and newborn care in the national VHT strategy, thereby helping to inform scale-up in rural Uganda. The study is registered as a randomized controlled trial, number ISRCTN50321130.

  • 23. Walsh, Eleanor I
    et al.
    Turner, Emma L
    Lane, J Athene
    Donovan, Jenny L
    Neal, David E
    Hamdy, Freddie C
    Martin, Richard M
    Characteristics of men responding to an invitation to undergo testing for prostate cancer as part of a randomised trial.2016In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 17, no 1, article id 497Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Sociodemographic characteristics are associated with participating in cancer screening and trials. We compared the characteristics of those responding with those not responding to a single invitation for prostate-specific antigen (PSA) testing for prostate cancer as part of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

    METHODS: Age, rurality and deprivation among 197,763 men from 271 cluster-randomised primary care centres in the UK were compared between those responding (n = 90,300) and those not responding (n = 100,953) to a prostate cancer testing invitation.

    RESULTS: There was little difference in age between responders and nonresponders. Responders were slightly more likely to come from urban rather than rural areas and were slightly less deprived than those who did not respond.

    CONCLUSION: These data indicate similarities in age and only minor differences in deprivation and urban location between responders and nonresponders. These differences were smaller, but in the same direction as those observed in other screening trials.

    TRIAL REGISTRATION: ISRCTN92187251 . Registered on 29 November 2004.

  • 24.
    Åsberg, Signild
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology. Riksstroke, Västerbotten County Council, Umeå, Sweden.
    Hijazi, Ziad
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Norrving, Bo
    Riksstroke, Västerbotten County Council, Umeå, Sweden.; Department of Neurology, Lund University, Lund, Sweden.
    Terént, Andreas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology. Riksstroke, Västerbotten County Council, Umeå, Sweden.
    Öhagen, Patrik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Oldgren, Jonas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial2017In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 18, no 1, article id 581Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Oral anticoagulation therapy is recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation (AF). Current guidelines do not provide evidence-based recommendations on optimal time-point to start anticoagulation therapy after an acute ischemic stroke. Non-vitamin K antagonist oral anticoagulants (NOACs) may offer advantages compared to warfarin because of faster and more predictable onset of action and potentially a lower risk of intracerebral haemorrhage also in the acute phase after an ischemic stroke. The TIMING study aims to establish the efficacy and safety of early vs delayed initiation of NOACs in patients with acute ischemic stroke and AF.

    METHODS/DESIGN: The TIMING study is a national, investigator-led, registry-based, multicentre, open-label, randomised controlled study. The Swedish Stroke Register is used for enrolment, randomisation and follow-up of 3000 patients, who are randomised (1:1) within 72 h from ischemic stroke onset to either early (≤ 4 days) or delayed (≥ 5-10 days) start of NOAC therapy. The primary outcome is the composite of recurrent ischemic stroke, symptomatic intracerebral haemorrhage, or all-cause mortality within 90 days after randomisation. Secondary outcomes include: individual components of the primary outcome at 90 and 365 days; major haemorrhagic events; functional outcome by the modified Rankin Scale at 90 days; and health economics. In an optional biomarker sub-study, blood samples will be collected after randomisation from approximately half of the patients for central analysis of cardiovascular biomarkers after study completion. The study is funded by the Swedish Medical Research Council. Enrolment of patients started in April 2017.

    CONCLUSION: The TIMING study addresses the ongoing clinical dilemma of when to start NOAC after an acute ischemic stroke in patients with AF. By the inclusion of a randomisation module within the Swedish Stroke Register, the advantages of a prospective randomised study design are combined with the strengths of a national clinical quality register in allowing simplified enrolment and follow-up of study patients. In addition, the register adds the possibility of directly assessing the external validity of the study findings.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT02961348 . Registered on 8 November 2016.

1 - 24 of 24
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf