Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists.

Objectives: To provide information on the frequency and reasons for outcome reporting bias in clinical trials.

Design: Trial protocols were compared with subsequent publication(s) to identify any discrepancies in the outcomes reported, and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes.

Participants: Chief investigators, or lead or coauthors of trials, were identified from two sources: trials published since 2002 covered in Cochrane systematic reviews where at least one trial analysed was suspected of being at risk of outcome reporting bias (issue 4, 2006; issue 1, 2007, and issue 2, 2007 of the Cochrane library); and a random sample of trial reports indexed on PubMed between August 2007 and July 2008.

Indirect comparisons: a review of reporting and methodological quality.

Background: The indirect comparison of two interventions can be valuable in many situations. However, the quality of an indirect comparison will depend on several factors including the chosen methodology and validity of underlying assumptions. Published indirect comparisons are increasingly more common in the medical literature, but as yet, there are no published recommendations of how they should be reported.

Racial differences in biologic predictors of severe asthma: Data from the Severe Asthma Research Program.

Background: Biologic factors are known to contribute to asthma severity. It is unknown whether these factors differentially contribute to asthma severity in black compared with white subjects.

Objective: We sought to assess the extent to which racial disparities between black and white subjects with severe asthma are attributable to physiologic, immunoinflammatory, and sociodemographic variables.

Assessing the potential for outcome reporting bias in a review: a tutorial.

Background: Outcome reporting bias (ORB) occurs when variables are selected for publication based on their results. This can impact upon the results of a meta-analysis, biasing the pooled treatment effect estimate.The aim of this paper is to show how to assess a systematic review and corresponding trial reports for ORB using an example review of intravenous and nebulised magnesium in the treatment of asthma.

The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews.

Objective: To examine the prevalence of outcome reporting bias-the selection for publication of a subset of the original recorded outcome variables on the basis of the results-and its impact on Cochrane reviews.

Design: A nine point classification system for missing outcome data in randomised trials was developed and applied to the trials assessed in a large, unselected cohort of Cochrane systematic reviews. Researchers who conducted the trials were contacted and the reason sought for the non-reporting of data.

Zoning: focused support: a trust wide implementation project.

Applying pragmatic risk management procedures to facilitate the sharing of clinical knowledge in and across mental health teams. Abstract Zoning: focused support is pragmatic risk management support procedure that enhances adherence to operational policies, provides a forum in which staff can receive support and visually facilitates the sharing of clinical knowledge. This paper presents a 3-year multi-method management project that sought to introduce zoning principles into all teams of an inner city Mental Health NHS Trust.

Enhanced relapse prevention for bipolar disorder by community mental health teams: cluster feasibility randomised trial.

Background: Relapse prevention for bipolar disorder increases time to relapse but is not available in routine practice.

Aims: To determine the feasibility and effectiveness of training community mental health teams (CMHTs) to deliver enhanced relapse prevention.

Method: In a cluster randomised controlled trial, CMHT workers were allocated to receive 12 h training in enhanced relapse prevention to offer to people with bipolar disorder or to continue giving treatment as usual.

A randomized comparative trial of generalized vs targeted physiotherapy in the management of childhood hypermobility.

Objective: Joint hypermobility, common in childhood, can be associated with severe pain and significant morbidity. Physiotherapy, the mainstay of treatment, lacks a robust evidence base. This study is aimed at determining the best physiotherapy intervention in managing childhood hypermobility.

The ecology of social transitions in human evolution.

We know that there are fundamental differences between humans and living apes, and also between living humans and their extinct relatives. It is also probably the case that the most significant and divergent of these differences relate to our social behaviour and its underlying cognition, as much as to fundamental differences in physiology, biochemistry or anatomy. In this paper, we first attempt to demarcate what are the principal differences between human and other societies in terms of social structure, organization and relationships, so that we can identify what derived features require explanation.

Antiviral effect of ribonuclease conjugated oligodeoxynucleotides targeting the IRES RNA of the hepatitis C virus.

Hepatitis C virus (HCV) translation initiation is mediated by a highly structured and conserved RNA, termed the Internal Ribosome Entry Site (IRES), located at the 5'-end of its single stranded RNA genome. It is a key target for the development of new antiviral compounds. Here we made use of the recently developed HCV cell culture system to test the antiviral activity of artificial ribonucleases consisting of imidazole(s) linked to antisense oligodeoxynucleotides targeting the HCV IRES.

Training staff in enhanced relapse prevention for bipolar disorder: rates of uptake and measures of skill and confidence.

Objective: This study examined the feasibility and effectiveness of training clinical staff in enhanced relapse prevention for people with bipolar disorder in routine services.

Methods: A cluster randomized controlled trial was conducted in North West England. This brief report focuses on the 56 staff who received enhanced relapse prevention.

Vaccines for preventing anthrax.

Background: Anthrax is a bacterial zoonosis that occasionally causes human disease and is potentially fatal. Anthrax vaccines include a live-attenuated vaccine, an alum-precipitated cell-free filtrate vaccine, and a recombinant protein vaccine.

Objectives: To evaluate the effectiveness, immunogenicity, and safety of vaccines for preventing anthrax.

The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematic review.

Objectives: To assess the clinical effectiveness of central venous catheters (CVCs) treated with anti-infective agents (AI-CVCs) in preventing catheter-related bloodstream infections (CRBSI).

Data Sources: MEDLINE (OVID), EMBASE, SCI//Web of Science, SCI/ISI Proceedings, and the Cochrane Library.

Study Selection: A systematic review of the literature was conducted using internationally recognized methodology.

Reporting of clinical trials: a review of research funders' guidelines.

Background: Randomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias.

Methods: National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs.

An encouraging assessment of methods to inform priorities for updating systematic reviews.

Objective: To consider the use of statistical methods that aim to prioritize the updating of a collection of systematic reviews based on preliminary literature searches.

Study Design And Setting: A new simulation-based method estimating statistical power and the ratio of the weights assigned to the predicted new and old evidence, and the existing Barrowman n approach is considered. Using only information on the numbers of subjects randomized in the "new" trials, these were applied retrospectively, by removing recent studies, to existing systematic reviews from the Cochrane Infectious Diseases Group.

Systematic review of the empirical evidence of study publication bias and outcome reporting bias.

Background: The increased use of meta-analysis in systematic reviews of healthcare interventions has highlighted several types of bias that can arise during the completion of a randomised controlled trial. Study publication bias has been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Until recently, outcome reporting bias has received less attention.

TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol.

Background: Infants born at extreme prematurity are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone described as hypothyroxinaemia, which is recognised to be a frequent phenomenon in these infants. Derangements of critical thyroid function during the sensitive window in prematurity when early development occurs, may have a range of long term effects for brain development.

The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation.

Objectives: To assess the clinical effectiveness and cost-effectiveness of central venous catheters (CVCs) treated with anti-infective agents in preventing catheter-related bloodstream infection (CRBSI).

Data Sources: Major electronic databases were searched from 1985 to August 2005.

Review Methods: The systematic clinical and economic reviews were conducted according to accepted procedures.

TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation.

Background: Infants born at extreme prematurity (below 28 weeks' gestation) are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone which is recognised to be a frequent phenomenon in these infants. At present it is unclear whether low levels of thyroid hormone are a cause of disability, or a consequence of concurrent adversity.

Big brains, small worlds: material culture and the evolution of the mind.

New developments in neuroimaging have demonstrated that the basic capacities underpinning human social skills are shared by our closest extant primate relatives. The challenge for archaeologists is to explain how complex human societies evolved from this shared pattern of face-to-face social interaction. We argue that a key process was the gradual incorporation of material culture into social networks over the course of hominin evolution.

A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial.

Objectives: To compare clinicians' choice of one of the standard epilepsy drug treatments (carbamazepine or valproate) versus appropriate comparator new drugs.

Design: A clinical trial comprising two arms, one comparing new drugs in carbamazepine and the other with valproate.

Setting: A multicentre study recruiting patients with epilepsy from hospital outpatient clinics.

Estrogen-receptor independent effects of two ubiquitous environmental estrogens on Melosira varians Agardh, a common component of the aquatic primary production community.

Estrogenic compounds have been discovered in many surface water samples in many anthropogenically altered surface waters. Wastewater effluent has been identified as a major pathway of contamination and found to revert much of the metabolic products of these biologically active compounds back to their original form. This presentation explains methodology for determining exposure effects through a newly developed bioassay, examining the physiological response of a diatom to these compounds.

Developing a parenting skills-and-support intervention for mothers with eating disorders and pre-school children: part 2. Piloting a group intervention.

Objective: This paper reports the development and preliminary evaluation of a group intervention for mothers with eating disorders who have pre-school children.

Method: This study aimed to define and clarify intervention components, and make a preliminary assessment of the feasibility, acceptability and potential for achieving clinical change of the group intervention.

Results: An eight-session group intervention was developed and piloted with four or five participants in each of three trials.

Developing a parenting skills-and-support intervention for mothers with eating disorders and pre-school children part 1: Qualitative investigation of issues to include.

Objective: This study aimed to (i) identify themes and issues that might usefully be addressed in a skills-and-support intervention for mothers with eating disorders who have children less than 5 years of age, and (ii) determine the most appropriate format for such an intervention.

Method: Focus groups and individual interviews were conducted with seven mothers with eating disorders and pre-school children, and four local health professionals working with mothers of pre-school children.

Results: Thematic analysis of interview transcripts revealed 10 themes: 'Passing on Traits', 'Food Preparation and Provision', 'Interactions Around Food and Mealtimes', 'Mother's Intake', 'Self Care', 'Self Identity and Parental Expectations', 'Impact on General Parent-Child Relationship', 'Need for Control', 'The Group Experience' and 'Practicalities and Format'.