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New WHO statement on reporting clinical trials
A NEW WHO statement reaffirming the “ethical imperative of clinical trial results reporting” would also define reporting time frames and outline steps to improve links between interventional clinical trial registry entries and published results, according to the authors of an article published in PLOS Medicine explaining the rationale of the changes. The authors said the statement updates and expands the WHO’s 2005 statement that “the registration of all interventional trials is a scientific, ethical and moral responsibility”. The 2005 statement said not reporting clinical trial results could lead to dissemination bias, leading to major adverse consequences such as inefficiencies in resource allocation for research and development, creating indirect costs for public and private entities including patients, and subjecting future volunteers to unnecessary risk. The authors wrote that in its new statement the WHO had outlined the need for reporting to occur in two modalities. “The first is for the main findings of clinical trials to be submitted for publication in a peer-reviewed journal within 12 months of study completion (defined as the final data collection date for the primary outcome measure), with a further 12 months allowed from first submission to publication”, the authors wrote. Additionally, they said the key results should be posted on the clinical trial registry or another accessible website within 12 months of study completion. The statement also calls for public disclosure of results from older, unreported clinical trials as these could still have an important bearing on scientific research today. Other components of the statement include a trial registry identifier in publications for easy linking of manuscripts with clinical trial registry entries. “Ensuring that all interventional clinical trials are reported will require action following the WHO statement”, the authors wrote. “Data indicate that the extent of results-reporting has been insufficient to date and that incentives and legislation are needed to achieve compliance. WHO calls for ethics committees, regulatory authorities, professional bodies, sponsors, investigators, and funding agencies to act in their jurisdictions to ensure results from all interventional clinical trials are reported and publicly disclosed.”
School-based sex abuse programs increase knowledge
A COCHRANE review of research into the effectiveness of school-based education programs to prevent child sexual abuse has found the programs do improve children’s protective behaviours and knowledge. The review, published by the Cochrane Database of Systematic Reviews, by Australian researchers included of 24 randomised controlled trials up to September 2014 with a total of 5802 participants, mostly at primary school. The researchers wrote that the quality of evidence for all outcomes included in the meta-analyses was moderate because of the risk of bias, so recommended the results be interpreted cautiously. They found evidence that the school-based programs increased children’s skills in protective behaviours and knowledge of sexual abuse prevention concepts (measured by questionnaires or vignettes) and that these knowledge gains were not significantly eroded 1‒6 months after the intervention. Children who attended a program also had greater odds of disclosing any abuse than children who had not attended There was no evidence that the programs increased or decreased children’s anxiety or fear. “Currently, schools implement a variety of interventions aimed at preventing child sexual abuse”, the researchers wrote. “It is likely that these interventions will be most useful as part of wider community initiatives promoting the safety of children, the contents, processes, and outcomes of which must be clearly defined and measured in rigorous evaluation designs.” However, they wrote that children’s increased knowledge of abuse “should not be seen as a replacement for society’s responsibility to ensure child safety”.
Depression-diabetes link to dementia
DEPRESSION and type 2 diabetes mellitus (DM) are each associated with a greater risk for all-cause dementia, Alzheimer disease and vascular dementia, and this risk is significantly higher in people with both conditions, new research has found. The population-based study, published in JAMA Psychiatry, included almost 2.5 million Danish citizens aged 50 years or older and free of dementia in 2007, who were followed for 7 years. The authors compared the risk for all-cause dementia among adults with depression, diabetes or both, with adults with neither condition, using data from national health registries. Overall, 19.4% of people had a diagnosis of depression, 9.1% had diabetes and 3.9% had both conditions. During the study period, 2.4% of the cohort developed dementia, and of these 10.8% had diabetes, 26.4% had depression and 6.7% had both conditions. The mean age of dementia diagnosis was 80.9 years. The authors said that compared with people without diabetes or depression, diabetes alone was associated with a 20% greater risk for all-cause dementia, and depression alone was associated with an 83% greater risk. People with both depression and diabetes had a 117% higher risk of developing dementia than those who had neither condition. The authors said the interaction between diabetes and depression was particularly strong for people younger than 65 years. “In light of the increasing societal burden of chronic diseases, further research is needed to elucidate the pathophysiologic mechanisms linking depression, DM, and adverse outcomes such as dementia and to develop interventions aimed at preventing these dreaded complications”, the authors wrote. An accompanying commentary said the study highlighted the need for “convergent scientific approaches to meet the challenge of promoting healthy brain aging and cognitive fitness into the last years of life”.
Health data breaches on the rise
REPORTS of data breaches of protected health information have increased in the US, involving about 29 million records, according to a research letter published in JAMA. The authors studied an online database maintained by the US Department of Health and Human Services, which described data breaches of unencrypted protected health information reported by health plans and clinicians. In total, 949 breaches that occurred across the US between 2010 and 2013 were evaluated, including six that involved more than a million records each. The authors found that 67% of breaches occurred via electronic media, frequently involving laptop computers or portable electronic devices. They grouped breaches as occurring via theft, loss or improper disposal of data, unauthorised data access or disclosure, hacking or information technology incidents, or other and missing. Most breaches occurred via theft. The combined frequency of breaches that resulted from hacking and unauthorised access or disclosure increased during the study period. Breaches involved external vendors in 29% of reports. The authors wrote that given the rapid expansion in use of electronic health records and the increased use of cloud-based services, the frequency and scope of data breaches was likely to increase. “Strategies to mitigate the risk and effect of these data breaches will be essential to ensure the well-being of patients, clinicians, and health care systems”, the authors said. An accompanying editorial said that data breaches could cause a loss of trust in the electronic health information system, and seriously undermine efforts to improve health care in the US. “The stakes associated with the privacy and security of personal health information are huge”, the editorial said.
Young children try e-cigs first
CHILDREN aged 10–16 years are more likely to try e-cigarettes than to smoke tobacco, but regular use is not common and is usually associated with smoking, a study has found. The research, published in BMJ Open, was based on the results of two nationally representative cross-sectional surveys of primary and secondary school children in Wales, conducted between 2013 and 2014. In total, 1601 children aged 10‒11 years and 9055 children aged 11‒16 years provided data on their exposure to smoking and use of e-cigarettes. A total of 5.8% of 10‒11-year-olds had tried e-cigarettes, while only 1.6% had tried tobacco. Among 11‒16-year-olds, 12.3% said they had used e-cigarettes, with no differences according to sex, ethnicity or family affluence, the authors said. The proportion of children who had ever used an e-cigarette and reported current tobacco smoking was 6.9% in 10‒11-year-olds and 39.2% in 15‒16-year-olds. Only 1.5% of 11‒16-year-olds reported regular e-cigarette use. Current weekly smokers were 100 times more likely than non-smokers to use e-cigarettes regularly, and regular e-cigarette use was more likely among those who smoked cannabis. The strong link between current smoking and e-cigarette use suggested that teens were not using e-cigarettes to help them quit smoking, the authors wrote. They said because there was a very low prevalence of regular use, e-cigarettes were unlikely to be making a significant direct contribution to adolescent nicotine addiction. However, they said further research was needed “to understand the motivations behind young people’s experimentation with e-cigarette use and to understand the temporal relationships between use of e-cigarettes and tobacco”.
Adhesive strips don’t improve dermal suture results
ADDING adhesive strips when suturing wounds after cutaneous surgical procedures does not significantly improve overall scar assessment compared with buried interrupted subcuticular suturing alone when evaluated by blinded observers or the patients themselves, according to the results of a randomised trial published in JAMA Dermatology. The prospective, randomised split-wound intervention included 48 patients aged 18 years or older with postoperative wounds of at least 3 cm resulting from either Mohs micrographic surgical procedures or surgical excision. The researchers found no significant difference in mean Patient Observer Scar Assessment Scale (POSAS) scores from the blinded reviewers for the two techniques for vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion at a 3-month assessment, and no significant difference in the mean patient POSAS scores between the sides of the scars for pain, itching, colour, stiffness, thickness, irregularity and overall opinion. There was no statistically significant difference for scar width at 3 months between the sides of the scars with and without adhesive strips. The authors said although the combined suturing was not current standard use, the finding “has significant implications as it may save surgeons time and the cost of the adhesive strips or additional sutures”.
No benefits from fish oil supplements for heart disease
AN expert review has recommended a revision of the 2008 National Heart Foundation of Australia recommendations on using omega-3 fatty acid supplementation for primary and secondary prevention of cardiovascular disease. In an article published in Heart Lung and Circulation, the experts reviewed new research on dietary and/or supplementation with omega-3 long-chain polyunsaturated fatty acids (LCPUFA) for heart health published between 2007 and 2014. They concluded that the summary of evidence showed there was neither beneficial nor adverse effects of omega-3 LCPUFA supplementation in primary or secondary prevention of coronary heart disease, no evidence of harm and no new evidence to support consumption of alpha-linolenic acid (ALA) over the current Australian guidelines. “However, the evidence continues to be positive for the role of omega-3 LCPUFA in treatment of hypertriglyceridaemia and a modest but positive benefit in heart failure”, they wrote. “There is some indication of benefit in atrial fibrillation and hypertension.” Based on the review, they said the Heart Foundation should recommend that all Australians aim to include two to three serves of fish (including oily fish) per week as part of a healthy heart eating pattern. The experts found dietary intake of fish was consistently found to be of benefit for protection from heart disease and stroke, and higher fish intake was associated with lower incident rates of heart failure and lower rates of sudden cardiac death, stroke and myocardial infarction. They said sources of ALA, such as walnuts, flaxseed (linseed), canola and soybean oils, should also be included in a healthy eating pattern. “Omega-3 LCPUFA supplements can be considered in patients with heart failure in addition to standard therapy”, the experts wrote, saying supplementation was effective for hypertriglyceridaemia.