Bmc Public Health
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Randomized Controlled Trial Multicenter Study
The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.
In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. ⋯ This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to deepen the knowledge of the program. We further discuss some issues regarding the implementation of the program in municipalities and city districts.
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Multicenter Study Comparative Study
Age biases in a large HIV and sexual behaviour-related internet survey among MSM.
Behavioural data from MSM are usually collected in non-representative convenience samples, increasingly on the internet. Epidemiological data from such samples might be useful for comparisons between countries, but are subject to unknown participation biases. ⋯ Internet samples are biased towards a lower median age because younger men are over-represented on MSM dating websites and therefore may be more likely to be recruited into surveys. Men diagnosed with HIV were over-represented in the internet survey, and increasingly so in the older age groups. A similar effect was observed in the age groups younger than 25 years. Self-reported peak prevalence and peak HIV diagnoses rates are often shifted to higher age groups in internet samples compared to surveillance data. Adjustment for age-effects on online accessibility should be considered when linking data from internet surveys with surveillance data.
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Randomized Controlled Trial Multicenter Study
Ending homelessness among people with mental illness: the At Home/Chez Soi randomized trial of a Housing First intervention in Toronto.
The At Home/Chez Soi (AH/CS) Project is a randomized controlled trial of a Housing First intervention to meet the needs of homeless individuals with mental illness in five cities across Canada. The objectives of this paper are to examine the approach to participant recruitment and community engagement at the Toronto site of the AH/CS Project, and to describe the baseline demographics of participants in Toronto. ⋯ Recruitment at the Toronto site of AH/CS project produced a sample of participants that reflects the diverse demographics of the target population. This study will provide much needed data on how to best address the issue of homelessness and mental illness in Canada.
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Multicenter Study
Getting back to work after injury: the UK Burden of Injury multicentre longitudinal study.
Injuries to working age adults are common and place a considerable burden on health services accounting for more than 10% of GP sick notes and 14% of those claiming benefits because they are unable to work in the UK. General practitioners (GPs) currently assess fitness to work and provide care and referral to other services to facilitate return to work (RTW). Recent UK recommendations suggest replacing GP sickness certification with independent assessments of fitness to work after four weeks sick leave. The impact of a wide range of injuries on RTW and subsequent need for independent fitness to work assessments has not been well studied in the UK. The aim of this study was to quantify RTW and factors predicting RTW following a wide range of injuries. ⋯ Injuries have a large impact on time off work, including amongst those whose injuries did not warrant hospital admission. The majority of injured people would require an in-depth fitness for work assessment if recent UK recommendations are implemented. Many people will have on-going pain, mobility problems, anxiety and depression at the point of assessment and it is important that patients are encouraged to use primary care services to address these problems. A range of factors may be useful for identifying those at risk of a slower recovery and a delayed RTW so that appropriate interventions can be provided to this group.
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Randomized Controlled Trial Multicenter Study
The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial.
A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood-brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention. ⋯ This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline) to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention.