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| 5. |
- Fitzsimmons-Craft, Ellen E., et al.
(author)
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Harnessing mobile technology to reduce mental health disorders in college populations : A randomized controlled trial study protocol
- 2021
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In: Contemporary Clinical Trials. - : ELSEVIER SCIENCE INC. - 1551-7144 .- 1559-2030. ; 103
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Journal article (peer-reviewed)abstract
- About a third of college students struggle with anxiety, depression, or an eating disorder, and only 20?40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach to detect mental health problems and engage college students in services. We have developed a transdiagnostic, low-cost mobile mental health targeted prevention and intervention platform that uses population-level screening to engage college students in tailored services that address common mental health problems. We will test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20+ colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or an eating disorder and who are not currently engaged in mental health services (N = 7884) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to referral, is associated with improved uptake, reduced clinical cases, disorder-specific symptoms, and improved quality of life and functioning. We will also test mediators, predictors, and moderators of improved mental health outcomes, as well as stakeholder-relevant outcomes, including cost-effectiveness and academic performance. This population-level approach to service engagement has the potential to improve mental health outcomes for the millions of students enrolled in U.S. colleges and universities.
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| 6. |
- Hansson, Mats G, et al.
(author)
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Ulysses contracts for the doctor and for the patient
- 2010
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1559-2030 .- 1551-7144. ; 31:3, s. 202-206
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Journal article (peer-reviewed)abstract
- Research subjects participating in randomised clinical trials have a right to drop out of a study without specifying any reason for this. However, leaving a trial may be contradictory to their own general interests in medical research since drop outs may lead to biased conclusions and loss of valuable medical information. We suggest in this paper that self-binding "Ulysses contracts" that are non-exploitative and based on autonomous decisions by research subjects as well as by investigating doctors should be implemented with stopping rules adjusted to the needs of different kinds of randomised clinical trials.
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| 7. |
- Hardy, Timothy, et al.
(author)
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The European NAFLD Registry : A real-world longitudinal cohort study of nonalcoholic fatty liver disease
- 2020
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In: Contemporary Clinical Trials. - : Elsevier. - 1551-7144 .- 1559-2030. ; 98
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Journal article (peer-reviewed)abstract
- Non-Alcoholic Fatty Liver Disease (NAFLD), a progressive liver disease that is closely associated with obesity, type 2 diabetes, hypertension and dyslipidaemia, represents an increasing global public health challenge. There is significant variability in the disease course: the majority exhibit only fat accumulation in the liver but a significant minority develop a necroinflammatory form of the disease (non-alcoholic steatohepatitis, NASH) that may progress to cirrhosis and hepatocellular carcinoma. At present our understanding of pathogenesis, disease natural history and long-term outcomes remain incomplete. There is a need for large, well characterised patient cohorts that may be used to address these knowledge gaps and to support the development of better biomarkers and novel therapies. The European NAFLD Registry is an international, prospectively recruited observational cohort study that aims to establish a large, highly-phenotyped patient cohort and linked bioresource. Here we describe the infrastructure, data management and monitoring plans, and the standard operating procedures implemented to ensure the timely and systematic collection of high-quality data and samples. Already recruiting subjects at secondary/tertiary care centres across Europe, the Registry is supporting the European Union IMI2-funded LITMUS Liver Investigation: Testing Marker Utility in Steatohepatitis consortium, which is a major international effort to robustly validate biomarkers that diagnose, risk stratify and/or monitor NAFLD progression and liver fibrosis stage. The European NAFLD Registry has the demonstrable capacity to support research and biomarker development at scale and pace.
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| 8. |
- Hedberg, Suzanne, et al.
(author)
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BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy
- 2019
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 84
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Journal article (peer-reviewed)abstract
- Background: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. Method: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. Conclusions: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505. © 2019 Elsevier Inc.
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| 10. |
- Jonsson, Ulf, 1974-, et al.
(author)
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Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioral disorders : A review of current practice
- 2014
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 38:1, s. 1-8
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Research review (peer-reviewed)abstract
- BackgroundData suggest that certain psychological interventions can induce harm in a significant number of patients. While the need for adequate reporting of harms in clinical trials has repeatedly been emphasized, it is uncertain whether such information routinely is collected and reported in trials within this research field.MethodWe used the two major databases in clinical psychology and medicine (PsycINFO and PubMed) to identify original publications from 2010 reporting randomized controlled trials of psychological interventions for patients with mental and behavioral disorders. Two reviewers searched the full-text reports for information about monitoring of adverse events, side effects, and deterioration.ResultsTotally 132 eligible trials were identified. Only 28 trials (21%) included information that indicated any monitoring of harms on patient level. Four (3%) of these trials provided a description of adverse events as well as the methods used for collecting these data. Five of the trials (4%) reported adverse events but gave incomplete information about the method. An additional four reports (3%) briefly stated that no adverse events occurred, whereas 15 trials (11%) only provided information on deterioration or indicated monitoring of deterioration. The probability of including harm-related information was related to the journal impact factor.ConclusionImportant information about harms is not reported systematically within this research field, suggesting that the risk of reporting bias is nontrivial in conclusions about the risk-benefit ratio of psychological treatments. Guidelines on how to define, detect, and report harms related to psychological interventions could facilitate better reporting.
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| 11. |
- Karlsson, Therese, 1979, et al.
(author)
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Effect of the New Nordic Diet compared with usual care on glucose control in gestational diabetes mellitus: Study protocol for the randomized controlled trial intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO)
- 2022
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1559-2030 .- 1551-7144. ; 115
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Journal article (peer-reviewed)abstract
- Background: Gestational diabetes mellitus (GDM) is a pregnancy complication associated with short- and long-term health consequences for mother and child. First line treatment is diet and exercise but there is a recognized knowledge gap as to what diet treatment is optimal. A healthy Nordic diet has been associated with improved health but no studies in women with GDM exist. The New Nordic Diet (NND) is an initiative with the purpose to develop a healthy Nordic diet including foods with the potential to grow in Nordic countries; including fruit, berries, vegetables, whole-grain cereal products, nuts, fish, and rapeseed oil. The purpose of the intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO) is to test if the NND compared with usual care improves glucose control in women with GDM. Methods: The iNDIGO study is a randomized parallel controlled trial where 50 women with GDM will be randomized to either an NND or usual care for 14 days (30–32 weeks of gestation). Participants in the NND group will receive menus and food bags containing foods to be consumed. Primary outcome is glycemic control (time in target) measured using continuous glucose monitoring. Compliance to the dietary intervention will be tested using dietary biomarkers and adherence questionnaires. Conclusion: Diet treatment represents first line treatment in GDM but it remains unclear what type of diets are effective. iNDIGO is an efficacy study and will provide evidence as to whether a healthy Nordic diet can improve glucose control in women with GDM. Trial registration: ClinicalTrials.gov registration Number: NCT04169243. Registered 19 November 2019, https://clinicaltrials.gov/ct2/show/NCT04169243.
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| 12. |
- Kempen, Thomas, et al.
(author)
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Medication Reviews Bridging Healthcare (MedBridge) : Study protocol for a pragmatic cluster-randomised crossover trial
- 2017
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 61, s. 126-132
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Journal article (peer-reviewed)abstract
- BACKGROUND: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence.AIM: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews.DESIGN: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial.SETTING: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties.PARTICIPANTS: Patients aged 65years or older, admitted to one of the study wards.EXCLUSION CRITERIA: Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission.INTERVENTIONS: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care.PRIMARY OUTCOME MEASURE: Incidence of unplanned hospital visits during a 12-month follow-up period.DATA COLLECTION AND ANALYSES: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models.RELEVANCE: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.
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| 13. |
- Kirn, Dylan R., et al.
(author)
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The Vitality, Independence, and Vigor in the Elderly 2 Study (VIVE2) : Design and methods
- 2015
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 43, s. 164-171
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Journal article (peer-reviewed)abstract
- Background: Nutritional supplementation may potentiate the increase in skeletal muscle protein synthesis following exercise in healthy older individuals. Whether exercise and nutrition act synergistically to produce sustained changes in physical functioning and body composition has not been well studied, particularly in mobility-limited older adults. Methods: The VIVE2 study was a multi-center, randomized controlled trial, conducted in the United States and Sweden. This study was designed to compare the effects of a 6-month intervention with a once daily, experimental, 4 fl. oz. liquid nutritional supplement providing 150 kcal, whey protein (20 g), and vitamin D (800 IU) (Nestle Health Science, Vevey, Switzerland), to a low calorie placebo drink (30 kcal, non-nutritive; identical format) when combined with group-based exercise in 150 community-dwelling, mobility-limited older adults. All participants participated in a structured exercise program (3 sessions/week for 6 months), which included aerobic, strength, flexibility, and balance exercises. Results: The primary outcome was 6-month change in 400 m walk performance (m/s) between supplement and placebo groups. Secondary outcomes included 6 month change in: body composition, muscle cross-sectional area, leg strength, grip strength, stair climb time, quality of life, physical performance, mood/depressive symptoms and nutritional status. These outcomes were selected based on their applicability to the health and wellbeing of older adults. Conclusions: The results of this study will further define the role of nutritional supplementation on physical functioning and restoration of skeletal muscle mass in older adults. Additionally, these results will help refine the current physical activity and nutritional recommendations for mobility-limited older adults.
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| 19. |
- McEvoy, Peter M., et al.
(author)
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Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder : Study protocol for a randomized controlled trial
- 2017
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In: Contemporary Clinical Trials. - : ELSEVIER SCIENCE INC. - 1551-7144 .- 1559-2030. ; 60, s. 34-41
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Journal article (peer-reviewed)abstract
- Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention.
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| 22. |
- Miller, Frank, et al.
(author)
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Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis
- 2014
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144 .- 1559-2030. ; 37:2, s. 189-199
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Journal article (peer-reviewed)abstract
- Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase Ila study followed by a Phase Ilb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach.
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| 23. |
- Pavlides, Michael, et al.
(author)
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Liver investigation: Testing marker utility in steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol
- 2023
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In: Contemporary Clinical Trials. - : ELSEVIER SCIENCE INC. - 1551-7144 .- 1559-2030. ; 134
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Journal article (peer-reviewed)abstract
- Non-alcoholic fatty liver disease (NAFLD) is the liver manifestation of the metabolic syndrome with global prevalence reaching epidemic levels. Despite the high disease burden in the population only a small proportion of those with NAFLD will develop progressive liver disease, for which there is currently no approved pharmacotherapy. Identifying those who are at risk of progressive NAFLD currently requires a liver biopsy which is problematic. Firstly, liver biopsy is invasive and therefore not appropriate for use in a condition like NAFLD that affects a large proportion of the population. Secondly, biopsy is limited by sampling and observer dependent variability which can lead to misclassification of disease severity. Non-invasive biomarkers are therefore needed to replace liver biopsy in the assessment of NAFLD. Our study addresses this unmet need. The LITMUS Imaging Study is a prospectively recruited multi-centre cohort study evaluating magnetic resonance imaging and elastography, and ultrasound elastography against liver histology as the reference standard. Imaging biomarkers and biopsy are acquired within a 100-day window. The study employs standardised processes for imaging data collection and analysis as well as a real time central monitoring and quality control process for all the data submitted for analysis. It is anticipated that the high-quality data generated from this study will underpin changes in clinical practice for the benefit of people with NAFLD. Study Registration: clinicaltrials.gov: NCT05479721
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| 28. |
- Störe, Siri Jakobsson, et al.
(author)
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The effects of a sleep robot intervention on sleep, depression and anxiety in adults with insomnia : Study protocol of a randomized waitlist-controlled trial
- 2021
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In: Contemporary Clinical Trials. - : Elsevier. - 1551-7144 .- 1559-2030. ; 110
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Journal article (peer-reviewed)abstract
- Insomnia is a common sleep disorder characterized by difficulties initiating sleep, maintaining sleep and/or early-morning awakenings. Hyperarousal is a common causal and maintaining factor in insomnia models. Different techniques to decrease arousal have shown to be effective. Calm breathing can be one approach to enhance sleep. The Somnox sleep robot looks like a bean-shaped cushion to hug, and it gives physical and auditive guidance to calm down the users' breathing. There is currently no impartial empirical evidence of the sleep robot's effects on insomnia. This study is a randomized waitlist-controlled trial with a recruitment target of a minimum of 44 adults with insomnia and sleep disturbing arousal. Participants will complete pre-, mid- and post-intervention assessments, in addition to a 1-month follow-up. The primary outcome measure is the Insomnia Severity Index. Secondary sleep outcome measures are the Pre-Sleep Arousal Scale, a sleep diary and actigraphy. A secondary comorbid symptoms outcome measure is the Hospital Anxiety and Depression Scale. The main research question is whether treated participants have greater improvements regarding symptoms of insomnia post-intervention, compared with the waitlist control group. The analytic approach will be mixed-effects models. The current study will increase the knowledge on breath guidance as a way to reduce hyperarousal and enhance sleep. The sleep robot is a novel method and a potential treatment option for people with insomnia, when the recommended first-line treatments of Cognitive Behavioral Therapy and pharmaceuticals are inaccessible or undesirable. The ethics of healthcare robotics is discussed.
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| 29. |
- Sverdlov, Oleksandr, et al.
(author)
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Opportunity for efficiency in clinical development : An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the cardiovascular field
- 2021
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In: Contemporary Clinical Trials. - : Elsevier. - 1551-7144 .- 1559-2030. ; 105
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Research review (peer-reviewed)abstract
- Modern data analysis tools and statistical modeling techniques are increasingly used in clinical research to improve diagnosis, estimate disease progression and predict treatment outcomes. What seems less emphasized is the importance of the study design, which can have a serious impact on the study cost, time and statistical efficiency. This paper provides an overview of different types of adaptive designs in clinical trials and their applications to cardiovascular trials. We highlight recent proliferation of work on adaptive designs over the past two decades, including some recent regulatory guidelines on complex trial designs and master protocols. We also describe the increasing role of machine learning and use of metaheuristics to construct increasingly complex adaptive designs or to identify interesting features for improved predictions and classifications.
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| 32. |
- Woodford, Joanne, et al.
(author)
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Recruitment into a guided internet based CBT (iCBT) intervention for depression : Lesson learnt from the failure of a prevalence recruitment strategy
- 2011
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In: Contemporary Clinical Trials. - : Elsevier. - 1551-7144 .- 1559-2030. ; 32:5, s. 641-648
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Journal article (peer-reviewed)abstract
- Introduction: Internet based Cognitive Behavioural Therapy (iCBT) represents a significant development in the way psychological interventions are delivered. Studies tend to recruit via common media channels leading to criticisms of biased sample sizes and limited generalisability to primary care settings.Aim: To evaluate the use of a prevalence recruitment strategy within primary care to recruit into an RCT examining a free to use iCBT intervention.Methods: Fully randomised controlled trial (RCT), utilising a prevalence based recruitment strategy, comparing the iCBT intervention with telephone support provided by NHS Direct Health Advisors with treatment-as-usual (TAU) control.Results: Recruitment rates were low with only 7 participants recruited over 8 months. Overall only 14% of expected study invitations were sent, with only 1% undertaking the consent and initial screening process.Discussion: Key differences with successful prevalence recruitment strategies highlight four main issues to consider when recruiting participants from primary care into iCBT studies--lack of equipoise, a need for an assertive approach, coding of depression in GP databases and help seeking behaviour in depression which can all act as potential contributors to failure to recruit. However other non-primary care recruitment methods, such as the use of media channels, which are already shown to be effective in non-primary care settings should be considered if these methods more accurately target the population who would be willing to adopt iCBT more generally.
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| 33. |
- Fantke, Peter, et al.
(author)
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Building a European exposure science strategy
- 2020
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In: Journal of Exposure Science and Environmental Epidemiology. - : Springer Science and Business Media LLC. - 1559-0631 .- 1559-064X. ; 30:6, s. 917-924
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Journal article (peer-reviewed)abstract
- Exposure information is a critical element in various regulatory and non-regulatory frameworks in Europe and elsewhere. Exposure science supports to ensure safe environments, reduce human health risks, and foster a sustainable future. However, increasing diversity in regulations and the lack of a professional identity as exposure scientists currently hamper developing the field and uptake into European policy. In response, we discuss trends, and identify three key needs for advancing and harmonizing exposure science and its application in Europe. We provide overarching building blocks and define six long-term activities to address the identified key needs, and to iteratively improve guidelines, tools, data, and education. More specifically, we propose creating European networks to maximize synergies with adjacent fields and identify funding opportunities, building common exposure assessment approaches across regulations, providing tiered education and training programmes, developing an aligned and integrated exposure assessment framework, offering best practices guidance, and launching an exposure information exchange platform. Dedicated working groups will further specify these activities in a consistent action plan. Together, these elements form the foundation for establishing goals and an action roadmap for successfully developing and implementing a 'European Exposure Science Strategy' 2020-2030, which is aligned with advances in science and technology.
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| 34. |
- Orru, Hans, et al.
(author)
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Potential health impacts of changes in air pollution exposure associated with moving traffic into a road tunnel
- 2015
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In: Journal of Exposure Science and Environmental Epidemiology. - : Springer Science and Business Media LLC. - 1559-0631 .- 1559-064X. ; 25:5, s. 524-531
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Journal article (peer-reviewed)abstract
- A planned 21 km bypass (18 km within a tunnel) in Stockholm is expected to reduce ambient air exposure to traffic emissions, but same time tunnel users could be exposed to high concentrations of pollutants. For the health impacts calculations in 2030, the change in annual ambient NOX and PM10 exposure of the general population was modelled in 100 x 100 m(2) grids for Greater Stockholm area. The tunnel exposure was estimated based on calculated annual average NOX concentrations, time spent in tunnel and number of tunnel users. For the general population, we estimate annually 23.7 (95% Cl: 17.7-32.3) fewer premature deaths as ambient concentrations are reduced. At the same time, tunnel users will be exposed to NOX levels up to 2000 mu g/m(-3). Passing through the whole tunnel two times on working days would correspond to an additional annual NOX exposure of 9.6 mu g/m(3). Assuming that there will be similar to 55,000 vehicles daily each way and 1.3 persons of 30-74 years of age in each vehicle, we estimate the tunnel exposure to result in 20.6 (95% Cl: 14.1-25.6) premature deaths annually. If there were more persons per vehicle, or older and vulnerable people travelling, or tunnel dispersion conditions worsen, the adverse effect would become larger.
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| 35. |
- Baxter, Judith, et al.
(author)
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Differences in recruitment and early retention among ethnic minority participants in a large pediatric cohort: The TEDDY Study
- 2012
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144. ; 33:4, s. 633-640
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Journal article (peer-reviewed)abstract
- Objective: The TEDDY Study is an international, multi-center prospective study designed to identify the environmental triggers of type 1 diabetes (T1D) in genetically at-risk children. This report investigates ethnic minority (EM) differences in patterns of enrollment and retention in the US centers. Methods: As of June 2009, 267,739 newborns had been screened at birth for high risk T1D genotypes. Data collected at the time of screening, enrollment and at the baseline visit were used. Descriptive and multiple-logistic regression analyses assessed differences between EM groups regarding exclusion, enrollment and early withdrawal. Results: Of the 10,975 eligible subjects, 6,912 (67%) were invited to participate. EM subjects were more likely to be excluded because of an inability to contact. Of those invited 3,265 (47%) enrolled by the age of 4.5 months. Adjusted analyses showed that except for those classified as other EM, the odds of enrolling were similar across groups. EM subjects had elevated early withdrawal rates. Adjusted models demonstrated that this was significantly more likely among Hispanic subjects. Conclusion: Understanding patterns associated with EM participation in research extends our ability to make more accurate inferences and permits assessment of strategies that promote inclusion of EM to better address health disparities. (C) 2012 Elsevier Inc. All rights reserved.
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| 36. |
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| 37. |
- Frobell, Richard, et al.
(author)
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The challenge of recruiting patients with anterior cruciate ligament injury of the knee into a randomized clinical trial comparing surgical and non-surgical treatment
- 2007
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144. ; 28:3, s. 295-302
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Journal article (peer-reviewed)abstract
- Aims: To determine the number of patients needed to be screened (NNS) and allocated (NNA) in order to include one participant in a randomized clinical trial (RCT), and to compare the characteristics of patients accepting or declining participation in the RCT. Methods: The recruitment process of an ongoing multicenter RCT, comparing surgical and non-surgical interventions after acute anterior cruciate ligament (ACL) injury of the knee is described. We use the known concept Number Needed to Screen (NNS) and introduce the new concept Number Needed to Allocate (NNA) as variables to support a priori sample size calculations of future investigations. Results: 560 patients were screened to identify 162 patients (29%) eligible for inclusion in the RCT. 41 of those declined participation for various reasons, the most common being unwillingness to undergo surgery (n=23) or unwillingness to risk conservative treatment (n=8). 19 patients were excluded after MRI assessment or arthroscopy. Thus, 102 (18%) patients were allocated to one of the two treatments in the RCT. The NNS was 5.5 individuals with an acute knee injury, and the NNA was 1.6 individuals eligible for inclusion, to include I patient in the RCT. Patients declining to participate in the RCT were more frequently self-employed and less frequently injured in sports activities than those accepting RCT participation. Conclusions: We suggest that the a priori sample size calculation needs to be multiplied by at least 5.5 to provide an estimate of the number needed to screen, or 1.6 to provide an estimate of the number needed to allocate in order to include the desired number of patients in a trial comparing surgical and non-surgical treatment of the ACL injured patient.
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| 38. |
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| 39. |
- Lernmark, Barbro, et al.
(author)
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Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study.
- 2011
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In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144. ; 32, s. 517-523
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Journal article (peer-reviewed)abstract
- OBJECTIVE: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study. METHOD: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (T1DM) were placed into one of three categories: enrolled, excluded, or refused to enroll. Enrollment, exclusion and refusal rates were compared across countries and between infants from the general population (GP) and infants with a first degree T1DM relative (FDR). A multivariate logistic model was used to identify factors associated with TEDDY enrollment. RESULTS: TEDDY enrollment, exclusion, and refusal rates differed by country and by GP/FDR status but reasons for refusal to enroll were similar across countries and GP/FDR populations. Sweden had the highest enrollment rate, US had the highest exclusion rate, and Finland had the highest refusal rate. FDR infants were more likely to enroll than GP infants. Inability to re-contact the family was the most common reason for exclusion. Primary reasons for refusal to enroll included protocol factors (e.g. blood draws) or family factors (e.g., too busy). Study enrollment was associated with FDR status, European country of origin, older maternal age, a singleton birth, and having another child in TEDDY. CONCLUSIONS: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families.
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| 42. |
- Penttinen, Heidi, et al.
(author)
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Recruitment of breast cancer survivors into a 12-month supervised exercise intervention is feasible
- 2009
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In: Contemporary clinical trials. - : Elsevier BV. - 1551-7144. ; 30:5, s. 457-63
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Journal article (peer-reviewed)abstract
- BACKGROUND: The BREX study is one of the largest randomised prospective exercise interventions of breast cancer survivors which aims at investigate whether regular exercise could reduce the long-term side effects of the adjuvant treatments and improve quality of life. MATERIAL AND METHODS: The study was limited to consider patients aged 35-68 years, who had recently completed adjuvant chemotherapy or started endocrine therapy. In this paper, we describe the recruitment process of the 413 randomised patients from the Helsinki University Hospital between September 2005 and September 2007. RESULTS: 768 potentially eligible patients out of the 1321 screened (via medical records) were contacted by phone. After the phone call 240 patients were excluded due to health problems that contraindicated exercise training. The most common health problems were musculoskeletal disorders. A total of 528 patients were considered as eligible for the intervention. Ultimately 413 of them agreed to participate resulting in a 53.8% recruitment rate of the potentially eligible patients. The most important reasons for declining were social, not health related. Eligible patients who did not want to participate did not differ significantly from those who participated according to age, health status, breast cancer treatment and tumour type. DISCUSSION: The high recruitment rate demonstrates breast cancer patient's willingness to participate even in long-lasting supervised exercise programs shortly after adjuvant treatments. After taking into account the selection of the population by age and musculoskeletal health, the results of the present intervention can be generalized to represent urban breast cancer patient population in Finland.
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