Trials In People Research Articles

Electromechanical-assisted training for walking after stroke.

Electromechanical- and robotic-assisted gait-training devices are used in rehabilitation and might help to improve walking after stroke. This is an update of a Cochrane Review first published in 2007. To investigate the effects of automated electromechanical- and robotic-assisted gait-training devices for improving walking after stroke. We searched the Cochrane Stroke Group Trials Register (last searched 9 August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 8), MEDLINE in Ovid (1950 to 15 August 2016), Embase (1980 to 15 August 2016), CINAHL (1982 to 15 August 2016), AMED (1985 to 15 August 2016), Web of Science (1899 to 16 August 2016), SPORTDiscus (1949 to 15 September 2012), the Physiotherapy Evidence Database (PEDro) (searched 16 August 2016), and the engineering databases COMPENDEX (1972 to 16 November 2012) and Inspec (1969 to 26 August 2016). We handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted authors in an effort to identify further published, unpublished, and ongoing trials. We included all randomised controlled trials and randomised controlled cross-over trials in people over the age of 18 years diagnosed with stroke of any severity, at any stage, in any setting, evaluating electromechanical- and robotic-assisted gait training versus normal care. Two review authors independently selected trials for inclusion, assessed methodological quality and risk of bias, and extracted the data. The primary outcome was the proportion of participants walking independently at follow-up. We included 36 trials involving 1472 participants in this review update. Electromechanical-assisted gait training in combination with physiotherapy increased the odds of participants becoming independent in walking (odds ratio (random effects) 1.94, 95% confidence interval (CI) 1.39 to 2.71; P < 0.001; I² = 8%; moderate-quality evidence) but did not significantly increase walking velocity (mean difference (MD) 0.04 m/s, 95% CI 0.00 to 0.09; P = 0.08; I² = 65%; low-quality evidence) or walking capacity (MD 5.84 metres walked in 6 minutes, 95% CI -16.73 to 28.40; P = 0.61; I² = 53%; very low-quality evidence). The results must be interpreted with caution because 1) some trials investigated people who were independent in walking at the start of the study, 2) we found variations between the trials with respect to devices used and duration and frequency of treatment, and 3) some trials included devices with functional electrical stimulation. Our planned subgroup analysis suggested that people in the acute phase may benefit, but people in the chronic phase may not benefit from electromechanical-assisted gait training. Post hoc analysis showed that people who are non-ambulatory at intervention onset may benefit, but ambulatory people may not benefit from this type of training. Post hoc analysis showed no differences between the types of devices used in studies regarding ability to walk, but significant differences were found between devices in terms of walking velocity. People who receive electromechanical-assisted gait training in combination with physiotherapy after stroke are more likely to achieve independent walking than people who receive gait training without these devices. We concluded that seven patients need to be treated to prevent one dependency in walking. Specifically, people in the first three months after stroke and those who are not able to walk seem to benefit most from this type of intervention. The role of the type of device is still not clear. Further research should consist of large definitive pragmatic phase III trials undertaken to address specific questions about the most effective frequency and duration of electromechanical-assisted gait training as well as how long any benefit may last.

Postural stability in one leg standing on dominant and non-dominant leg in professional soccer players

Stability plays a key role in the sport competition in football. Synchronized operation stabilization of the lower limb and trunk of the support with the dynamic movement of the contralateral limbs allow you to perform tasks specific to the discipline, eg. variety kicking of the ball. Purpose. The aim of the study was to evaluate differences in the capabilities to maintain postural stability in standing on one leg dominant and non-dominant leg with professional players including grouping variables: age, height, weight, volume of training aimed at improving the stability and general internship of football player career. Although commonly assumed that the non-dominant leg is predisposed to act more effective support for the body, the work to date have failed to identify indicated differentiation. It should be noted, however, that they were carried out on small trials in people less active, or among amateur athletes. Basic procedures. The study involved 31 professional soccer players from 1 to 5 level of division. In order to assess postural stability, each of the test performed three times a standard stability test consisting of three 20-second attempt to maintain balance on one leg becoming dominant and non-dominant leg on stabilometric platform BIODEX Balance System. For each of the lower limbs test was repeated three times. Assessment were average angular range deflections platform in the two reference planes, and the volatility of these deflections. These parameters were treated as a measure of postural stability of the respondents. Main findings. In the whole group of patients, no statistically significant differences in the possibilities to maintain postural stability in standing on one leg dominant and non-dominant leg. No significant differences were also detected when considering grouping variables. Conclusions. The results do not indicate a significant difference in the ability to maintain postural stability in standing on one leg dominant and non-dominant leg in professional soccer players.

It’s a Boy: Ethical Implications of the First Spindle Nuclear Transfer Birth

It’s a Boy: Ethical Implications of the First Spindle Nuclear Transfer Birth

Emollients and moisturisers for eczema.

Emollients and moisturisers for eczema.

DOP008 Dietary manipulation of the healthy human and colitic murine gut microbiome by CD-TREAT diet and exclusive enteral nutrition; a proof of concept study

Background: The extensive modulation of gut microbiome in children with Crohn's disease (CD) treated with exclusive enteral nutrition (EEN) offers clues about EEN's potential mode of action; but also on the development of novel therapies through dietary manipulation of the gut microbiota. This proof of concept study compared the effect of a novel “ordinary” food-based diet (CD-TREAT diet) and EEN on healthy human and colitic murine gut microbiota. Methods: A) Healthy adults followed two experimental diets for 7 days with a 15 day wash out period in between; EEN and CD-TREAT, an “ordinary” food diet which has similar nutrient and food ingredient composition to EEN (e.g., fibre, gluten, lactose content and fatty acid composition). Participants were randomly allocated to start with EEN or CD-TREAT first. Fresh faecal and urine samples were collected before and after each dietary intervention and 16s rRNA sequencing, untargeted faecal and urine metabolomics (using LC-MS) were performed; B) 10-month-old HLA-B27 and HLA-B7 trangenic rats received EEN, CD-TREAT diet or regular rat chow for 4 weeks. Faeces were collected at baseline, 1, 2, 3 and 4 weeks post treatment initiation. Gut contents, ileal and colonic tissue were harvested at sacrifice. Disease activity was quantified by blinded histological scores and gut microbiota metabolic activity was measured by faecal short chain fatty acids (SCFA) quantification. Results: A) 100 samples were collected from 25 healthy subjects. During EEN and CD-TREAT gut bacterial community structure (using OTUs) significantly changed after both EEN and CD-TREAT (R2=0.15, R2=0.05, p<0.004) and shifted towards the same direction. EEN's and CD-TREAT's impact on 3% OTU community structures was strongly correlated (Adj R2=0.38, p<2.2e-16). Similarly, untargeted faecal metabolomics revealed a strong correlation between the changes during EEN and CD-TREAT (Pearson's R=0.31, p<10–14)$; B) 100 faecal samples were collected from 12 HLA-B27 and 8 HLA-B7 adult transgenic rats. Both dietary interventions increased the body weight of the HLA-B27 rats (Median %weight change, EEN:+9.2 vs CD-TREAT:+15.7 vs Control:-2.1) and decreased the weight of caecum and colon contents. Faecal concentration of total SCFA, acetic, propionate decreased while iso-butyric and isocaproic increased during both dietary interventions [ΔMedian μmol/g, EEN: −324, −271, −44.8, +4.7, +2.2 vs CD-TREAT: −354, −292, −56.2, +3, +1.5]. Histopathology scores revealed that both dietary interventions benefited moderately ileal but not colonic inflammation. Conclusions: We have developed an “EN composition alike” food based diet which induces similar effects on gut microbiome with EEN. This proof of concept study supports a subsequent pilot trial in people with active CD.

Self-monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes (The SMBG Study): study protocol for a randomised controlled trial

BackgroundThe benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2 diabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued debate. Lack of a consistent finding has been attributed to variations in study population and design, including the SMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and health care provider are educated to detect patterns of glycaemic abnormality and take appropriate action according to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall well-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in non-insulin treated type 2 diabetes.MethodsThe SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes not on insulin therapy who have poor glycaemic control (HbA1c ≥58 mmol/mol / 7.5%). The participants will be randomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care; Group 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG with additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from 16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at 12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and 12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study. Recruitment began in December 2012 with the last participant visit due in September 2016.DiscussionThis study will attempt to answer the question of whether structured SMBG provides any benefits to people with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also clarify whether the telecare support provides additional value. The overall acceptability of SMBG as a tool for self-management will be assessed.Trial registrationUKCRN 12038 (Registered March 2012).ISRCTN21390608 (Retrospectively registered 15th May 2014).

Pancreatic enzyme replacement therapy for people with cystic fibrosis.

Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is taken, and the dose needs to be adjusted according to the food consumed. A systematic review on the efficacy and safety of pancreatic enzyme replacement therapy is needed to guide clinical practice, as there is variability between centres with respect to assessment of pancreatic function, time of commencing treatment, dose and choice of supplements. This is an updated version of a published review. To evaluate the efficacy and safety of pancreatic enzyme replacement therapy in children and adults with cystic fibrosis and to compare the efficacy and safety of different formulations of this therapy and their appropriateness in different age groups. Also, to compare the effects of pancreatic enzyme replacement therapy in cystic fibrosis according to different diagnostic subgroups (e.g. different ages at introduction of therapy and different categories of pancreatic function). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 15 July 2016.We also searched an ongoing trials website and the websites of the pharmaceutical companies who manufacture pancreatic enzyme replacements for any additional trials. Most recent search: 22 July 2016. Randomised and quasi-randomised controlled trials in people of any age, with cystic fibrosis and receiving pancreatic enzyme replacement therapy, at any dosage and in any formulation, for a period of not less than four weeks, compared to placebo or other pancreatic enzyme replacement therapy preparations. Two authors independently assessed trials and extracted outcome data. They also assessed the risk of bias of the trials included in the review. One parallel trial and 12 cross-over trials of children and adults with cystic fibrosis were included in the review. The number of participants in each trial varied between 14 and 129 with a total of 512 participants included in the review. All the included trials were for a duration of four weeks. The included trials had mostly an unclear risk of bias from the randomisation process as the details of this were not given; they also mostly had a high risk of attrition bias and reporting bias.We could not combine data from all the trials as they compared different formulations. Findings from individual studies provided insufficient evidence to determine the size and precision of the effects of different formulations. Ten studies reported information on the review's primary outcome (nutritional status); however, we were only able to combine data from two small cross-over studies (n = 41). The estimated gain in body weight was imprecise, 0.32 kg (95% confidence interval -0.03 to 0.67; P = 0.07). Combined data from the same studies gave statistically significant results favouring enteric-coated microspheres over enteric-coated tablets for our secondary outcomes stool frequency, mean difference -0.58 (95% confidence interval -0.85 to -0.30; P < 0.0001); proportion of days with abdominal pain, mean difference -7.96% (95% confidence interval -12.97 to -2.94; P = 0.002); and fecal fat excretion, mean difference -11.79 g (95% confidence interval -17.42 to -6.15; P < 0.0001). Data from another single small cross-over study also favoured enteric-coated microspheres over non-enteric-coated tablets with adjuvant cimetidine in terms of stool frequency, mean difference -0.70 (95% confidence interval -0.90 to -0.50; P < 0.00001). There is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month. In the only comparison where we could combine any data, the fact that these were cross-over studies is likely to underestimate the level of inconsistency between the results of the studies due to over-inflation of confidence intervals from the individual studies.There is no evidence on the long-term effectiveness and risks associated with pancreatic enzyme replacement therapy. There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency, optimum time to start treatment and variations based on differences in meals and meal sizes. There is a need for a properly designed study that can answer these questions.

Antifungal therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.

Allergic bronchopulmonary aspergillosis (ABPA) is an allergic reaction to colonisation of the lungs with the fungus Aspergillus fumigatus and affects around 10% of people with cystic fibrosis. ABPA is associated with an accelerated decline in lung function. High doses of corticosteroids are the main treatment for ABPA; although the long-term benefits are not clear, their many side effects are well-documented. A group of compounds, the azoles, have activity against Aspergillus fumigatus and have been proposed as an alternative treatment for ABPA. Of this group, itraconazole is the most active. A separate antifungal compound, amphotericin B, has been employed in aerosolised form to treat invasive infection with Aspergillus fumigatus, and may have potential for the treatment of ABPA. Antifungal therapy for ABPA in cystic fibrosis needs to be evaluated. This is an update of a previously published review. The review aimed to test the hypotheses that antifungal interventions for the treatment of ABPA in cystic fibrosis:1. improve clinical status compared to placebo or standard therapy (no placebo);2. do not have unacceptable adverse effects.If benefit was demonstrated, we aimed to assess the optimal type, duration and dose of antifungal therapy. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings.In addition, pharmaceutical companies were approached.Date of the most recent search of the Group's Trials Register: 29 September 2016. Published or unpublished randomised controlled trials, where antifungal treatments have been compared to either placebo or no treatment, or where different doses of the same treatment have been used in the treatment of ABPA in people with cystic fibrosis. Four trials were identified by the searches; none of which was judged eligible for inclusion in the review. No completed randomised controlled trials were included. At present, there are no randomised controlled trials to evaluate the use of antifungal therapies for the treatment of ABPA in people with cystic fibrosis, although trials in people who do not have cystic fibrosis have shown clinical and serological evidence of improvement and a reduction in the use of corticosteroids with no increase in adverse effects. Trials with clear outcome measures are needed to properly evaluate this potentially useful treatment for cystic fibrosis.

Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: a meta-analysis and systematic review.

Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: a meta-analysis and systematic review.

Albuminuria Changes and Cardiovascular and Renal Outcomes in Type 1 Diabetes: The DCCT/EDIC Study.

In trials of people with type 2 diabetes, albuminuria reduction with renin-angiotensin system inhibitors is associated with lower risks of cardiovascular events and CKD progression. We tested whether progression or remission of microalbuminuria is associated with cardiovascular and renal risk in a well characterized cohort of type 1 diabetes. We studied 1441 participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study. Albumin excretion rate (AER) was quantified annually or biennially for up to 30 years. For each participant, albuminuria status was defined over time as normoalbuminuria (AER continuously <30 mg/d), sustained microalbuminuria (AER, 30-299 mg/d on two consecutive visits), macroalbuminuria (AER≥300 mg/d), or remitted microalbuminuria (transition from sustained microalbuminuria to AER<30 mg/d on two consecutive visits). We tested associations of time-updated albuminuria status with adjudicated clinical cardiovascular events, the development of reduced GFR (<60 ml/min per 1.73 m2 on two consecutive visits), and subclinical cardiovascular disease. At least one cardiovascular event occurred in 184 participants, and 98 participants developed reduced eGFR. Compared with normoalbuminuria, sustained microalbuminuria, remitted microalbuminuria, and macroalbuminuria were each associated with higher risk of cardiovascular events (adjusted hazard ratios [HRs] and 95% confidence intervals [95% CIs]: 1.79 [1.13 to 2.85], 2.62 [1.68 to 4.07], and 2.65 [1.68 to 4.19], respectively) and reduced eGFR (adjusted HRs [95% CIs], 5.26 [2.43 to 11.41], 4.36 [1.80 to 10.57], and 54.35 [30.79 to 95.94], respectively). Compared with sustained microalbuminuria, remission to normoalbuminuria was not associated with reduced risk of cardiovascular events (adjusted HR, 1.33; 95% CI, 0.68 to 2.59) or reduced eGFR (adjusted HR, 1.75; 95% CI, 0.56 to 5.49). Compared with normoalbuminuria, sustained microalbuminuria, remitted microalbuminuria, and macroalbuminuria were associated with greater carotid intima-media thickness, and macroalbuminuria was associated with a greater degree of coronary artery calcification. In type 1 diabetes, microalbuminuria and macroalbuminuria are associated with higher risks of cardiovascular disease and reduced eGFR, but achieving a remission of established microalbuminuria to normoalbuminuria does not appear to improve outcomes.

Adaptive vs. non-adaptive cognitive training by means of a personalized App: a randomized trial in people with multiple sclerosis.

BackgroundCognitive impairment is common in multiple sclerosis (MS), but the definition of the best cognitive rehabilitation tools and features is still an open issue among researchers. The aims of the present study were to evaluate the effectiveness of COGNI-TRAcK (a customized application software delivering personalized working memory-based exercises) on cognitively impaired people with MS and to investigate the effects of an adaptive vs. a non-adaptive cognitive training administered by means of COGNI-TRAcK.MethodsTwenty eight patients (20 women, age 47.5 ± 9.3 years, Expanded Disability Status Scale score 3.8 ± 1.9) were randomized in two homogeneous groups, both performing a 8-week home-based cognitive rehabilitation treatment by means of COGNI-TRAcK. The study group (ADAPT-gr) underwent an adaptive training given by the automatic adjustment of tasks difficulty to the subjects’ performance, whilst the control group (CONST-gr) was trained at constant difficulty levels. Before and after the treatment, patients’ cognitive status was assessed using a gold standard neuropsychological evaluation. Moreover, the mostly affected cognitive domains in MS (i.e., attention, concentration and information processing speed) were also assessed 6 months after the end of the treatment.ResultsThe analysis of variance showed a significant Group*Time interaction in six out of ten tests of the cognitive evaluation. Post-hoc analysis revealed a significant improvement between the performances before and after the intervention only in the ADAPT-gr in tests evaluating verbal memory acquisition (p <0.05) and delayed recall (p = 0.001), verbal fluency (p = 0.01), sustained attention, concentration and information processing speed (p < 0.01). This last effect was maintained also after 6 months (p < 0.05).ConclusionsWe concluded that COGNI-TRAcK represents a suitable tool to administer a personalized training to cognitively impaired subjects and that an adaptive working load is a crucial feature determining the effectiveness of cognitive treatment, allowing transfer effects to several cognitive domains and long-term maintenance of results.

Vitamin D for the management of asthma.

Several clinical trials of vitamin D to prevent asthma exacerbation and improve asthma control have been conducted in children and adults, but a meta-analysis restricted to double-blind, randomised, placebo-controlled trials of this intervention is lacking. To evaluate the efficacy of administration of vitamin D and its hydroxylated metabolites in reducing the risk of severe asthma exacerbations (defined as those requiring treatment with systemic corticosteroids) and improving asthma symptom control. We searched the Cochrane Airways Group Trial Register and reference lists of articles. We contacted the authors of studies in order to identify additional trials. Date of last search: January 2016. Double-blind, randomised, placebo-controlled trials of vitamin D in children and adults with asthma evaluating exacerbation risk or asthma symptom control or both. Two review authors independently applied study inclusion criteria, extracted the data, and assessed risk of bias. We obtained missing data from the authors where possible. We reported results with 95% confidence intervals (CIs). We included seven trials involving a total of 435 children and two trials involving a total of 658 adults in the primary analysis. Of these, one trial involving 22 children and two trials involving 658 adults contributed to the analysis of the rate of exacerbations requiring systemic corticosteroids. Duration of trials ranged from four to 12 months, and the majority of participants had mild to moderate asthma. Administration of vitamin D reduced the rate of exacerbations requiring systemic corticosteroids (rate ratio 0.63, 95% CI 0.45 to 0.88; 680 participants; 3 studies; high-quality evidence), and decreased the risk of having at least one exacerbation requiring an emergency department visit or hospitalisation or both (odds ratio (OR) 0.39, 95% CI 0.19 to 0.78; number needed to treat for an additional beneficial outcome, 27; 963 participants; 7 studies; high-quality evidence). There was no effect of vitamin D on % predicted forced expiratory volume in one second (mean difference (MD) 0.48, 95% CI -0.93 to 1.89; 387 participants; 4 studies; high-quality evidence) or Asthma Control Test scores (MD -0.08, 95% CI -0.70 to 0.54; 713 participants; 3 studies; high-quality evidence). Administration of vitamin D did not influence the risk of serious adverse events (OR 1.01, 95% CI 0.54 to 1.89; 879 participants; 5 studies; moderate-quality evidence). One trial comparing low-dose versus high-dose vitamin D reported two episodes of hypercalciuria, one in each study arm. No other study reported any adverse event potentially attributable to administration of vitamin D. No participant in any included trial suffered a fatal asthma exacerbation. We did not perform a subgroup analysis to determine whether the effect of vitamin D on risk of severe exacerbation was modified by baseline vitamin D status, due to unavailability of suitably disaggregated data. We assessed two trials as being at high risk of bias in at least one domain; neither trial contributed data to the analysis of the outcomes reported above. Meta-analysis of a modest number of trials in people with predominantly mild to moderate asthma suggests that vitamin D is likely to reduce both the risk of severe asthma exacerbation and healthcare use. It is as yet unclear whether these effects are confined to people with lower baseline vitamin D status; further research, including individual patient data meta-analysis of existing datasets, is needed to clarify this issue. Children and people with frequent severe asthma exacerbations were under-represented; additional primary trials are needed to establish whether vitamin D can reduce the risk of severe asthma exacerbation in these groups.

Recommending Oral Probiotics to Reduce Winter Antibiotic Prescriptions in People With Asthma: A Pragmatic Randomized Controlled Trial.

Evidence from studies mainly in children has shown that orally administered probiotics may prevent respiratory tract infections and associated antibiotic use. We evaluated whether advice to take daily probiotics can reduce antibiotic prescribing for winter respiratory tract infections in people with asthma. We conducted a randomized controlled, parallel-group pragmatic study for participants aged 5 years and older with asthma in a UK primary care setting. The intervention was a postal leaflet with advice to take daily probiotics from October 2013 to March 2014, compared with a standard winter advice leaflet. Primary outcome was the proportion of participants prescribed antibiotics for respiratory tract infections. There were 1,302 participants randomly assigned to a control group (n = 650) or intervention group (n = 652). There was no significant difference in the primary outcome measure, with 27.7% receiving antibiotics in the intervention group and 26.9% receiving antibiotics in the control group (odds ratio = 1.04; 95% CI, 0.82-1.34). Uptake of probiotics was low, but outcomes were similar in those who accessed probiotics (adjusted odds ratio = 1.08; 95% CI, 0.69-1.69, compared with controls). We also found no evidence of an effect on respiratory tract infections or asthma exacerbations. In this pragmatic community-based trial in people with asthma, we found no evidence that advising use of winter probiotics reduces antibiotic prescribing.

WITHDRAWN: Therapeutic touch for healing acute wounds.

Therapeutic Touch (TT) is an alternative therapy that has gained popularity over the past two decades for helping wounds to heal. Practitioners enter a meditative state and pass their hands above the patient's body to find and correct any imbalances in the patient's 'life energy' or chi. Scientific instruments have been unable to detect this energy. The effect of TT on wound healing has been expounded in anecdotal publications. To identify and review all relevant data to determine the effects of TT on healing acute wounds. In January 2014, for this fifth update, we searched The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. All randomised or quasi-randomised controlled trials, which compared the effect of TT with a placebo, another treatment, or no treatment control were considered. Studies which used TT as a stand-alone treatment, or as an adjunct to other therapies, were eligible. One author (DO'M) determined the eligibility for inclusion of all trials in the review. Both authors conducted data extraction and evaluation of trial validity independently. Each trial was assessed using predetermined criteria. No new trials were identified for this update. Four trials in people with experimental wounds were included. The effect of TT on wound healing in these studies was variable. Two trials (n = 44 & 24) demonstrated a significant increase in healing associated with TT, while one trial found significantly worse healing after TT and the other found no significant difference. All trials are at high risk of bias. There is no robust evidence that TT promotes healing of acute wounds.

Therapeutic touch for healing acute wounds.

Therapeutic Touch (TT) is an alternative therapy that has gained popularity over the past two decades for helping wounds to heal. Practitioners enter a meditative state and pass their hands above the patient's body to find and correct any imbalances in the patient's 'life energy' or chi. Scientific instruments have been unable to detect this energy. The effect of TT on wound healing has been expounded in anecdotal publications. To identify and review all relevant data to determine the effects of TT on healing acute wounds. In January 2014, for this fifth update, we searched The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. All randomised or quasi-randomised controlled trials, which compared the effect of TT with a placebo, another treatment, or no treatment control were considered. Studies which used TT as a stand-alone treatment, or as an adjunct to other therapies, were eligible. One author (DO'M) determined the eligibility for inclusion of all trials in the review. Both authors conducted data extraction and evaluation of trial validity independently. Each trial was assessed using predetermined criteria. No new trials were identified for this update. Four trials in people with experimental wounds were included. The effect of TT on wound healing in these studies was variable. Two trials (n = 44 & 24) demonstrated a significant increase in healing associated with TT, while one trial found significantly worse healing after TT and the other found no significant difference. All trials are at high risk of bias. There is no robust evidence that TT promotes healing of acute wounds.

Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation.

Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation.

A 6-month randomised controlled trial investigating effects of Mediterranean-style diet and fish oil supplementation on dietary behaviour change, mental and cardiometabolic health and health-related quality of life in adults with depression (HELFIMED): study protocol

Modern diets, characterised by excess consumption of processed foods, are accompanied by an epidemic of chronic diseases. Cardiovascular disease and depression carry a large burden of disease and often occur together. Poor dietary patterns have been identified as an independent risk factor for depression while healthy diets with minimally processed food are protective. Traditional Mediterranean diets have been shown to reduce risk of cardiovascular disease; however there is a need for clinical trials in people with depression. This paper reports the study protocol of a Mediterranean-style diet intervention conducted in adults with self-reported depression. HELFIMED is a parallel 6-month randomised controlled trial investigating whether dietary patterns can be improved in people with depressive symptoms and whether healthier diet combined with fish oil supplementation can improve mental and cardiometabolic health and quality of life. Adults aged 18–65 years with self-reported depressive symptoms over the previous two months (N = 163) were block-randomised on age and gender between May 2014 and June 2015 to receive nutrition education, food hampers, fortnightly cooking workshops based on Mediterranean-style dietary principles for 3 months and fish oil supplementation for 6 months, or to attend fortnightly social groups (control group) for 3 months. All participants completed mental health (DASS and PANAS), quality of life, dietary and shopping and budgeting questionnaires and provided anthropometric measurements, blood and urine samples at baseline, 3 and 6 months. Additionally the treatment group attended focus groups at 3 and 6 months. Primary and secondary outcomes will be analysed using linear mixed modelling and correlations will investigate associations between improved health outcomes and subjective/objective measures of improved diet/nutritional status. This study will contribute causal evidence to prior observational and longitudinal studies that have shown associations between Mediterranean diet and mental health. The results will inform public health and clinical strategies for treatment of depression and comorbid cardiometabolic risk factors. Australian New Zealand Clinical Trials Register ( ACTRN12614000438651 ). Trial registration date: 23rd April 2014.

Influence of nutritional status on asthma condition in the population

Asthma is a chronic disease characterized by airway inflammation and bronchoconstriction. There are different factors that can favor this process, but the role of diet is especially important. Thus, inadequate nutritional status in some nutrients causes alterations in immune function and antioxidant defense mechanisms that may facilitate the onset of inflammatory processes in the pulmonary system. Thus, intervention studies with antioxidant vitamins have shown mixed results. Nevertheless, having in mind the low consumption of fruits and vegetables and the low intake of antioxidant nutrients of the population, a first step could be to approximate the diet to the theoretical ideal to reach the recommended intakes. Furthermore, it is important follow an adequate diet during the pregnancy because during this period the diet affects fetal development, which can be related to the suffering of asthma in childhood, and even in adulthood. In addition, in relation with other less studied nutrients, such as vitamin D and those nutrients methyl donors, would be interesting to conduct randomized controlled trials in people with risk of asthma or with established asthma to test their effect.

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND)

BackgroundClinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised ‘2 × 2 factorial design’ study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data.ResultsInformation on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised.ConclusionIf sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively.Trial registrationCurrent Controlled Trials, ISRCTN60635500, registered on 14 July 2005Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1354-9) contains supplementary material, which is available to authorized users.

Bending the Arc of Exercise and Recreation Technology Toward People With Disabilities

Most of the published research on exercise and disability has focused on short-term efficacy studies targeting specific disability groups. These studies often use grant-related or other financial resources to temporarily remove the many barriers that people with physical/mobility disability experience when attempting to become physically active. In this commentary, we explore how technology can be used to promote more sustainable physical activity outcomes in the home and community using a set of 4 overlapping domains: Access, Usability, Adherence, and Health and Function. In addition, we describe how the order in which these domains should be addressed will vary depending on the needs of the target group and the context of their environment. Finally, we provide examples of various types of technologies (eg, hardware and software) that can support the “afterlife” of successful short-term exercise and rehabilitation trials in people with physical/mobility disability who desire to self-manage their own health and maintain a regular and sustainable pattern of physical activity across their life span.