Repetitive arm functional tasks after stroke (RAFTAS): a pilot randomised controlled trial

Background Repetitive functional task practise (RFTP) is a promising treatment to improve upper limb recovery following stroke. We report the findings of a study to determine the feasibility of a multi-centre randomised controlled trial to evaluate this intervention. Methods A pilot randomised controlled trial was conducted. Patients with new reduced upper limb function were recruited within 14 days of acute stroke from three stroke units in North East England. Participants were randomised to receive a four week upper limb RFTP therapy programme consisting of goal setting, independent activity practise, and twice weekly therapy reviews in addition to usual post stroke rehabilitation, or usual post stroke rehabilitation. The recruitment rate; adherence to the RFTP therapy programme; usual post stroke rehabilitation received; attrition rate; data quality; success of outcome assessor blinding; adverse events; and the views of study participants and therapists about the intervention were recorded. Results Fifty five eligible patients were identified, 4-6% of patients screened at each site. Twenty four patients participated in the pilot study. Two of the three study sites met the recruitment target of 1-2 participants per month. The median number of face to face therapy sessions received was 6 [IQR 3-8]. The median number of daily repetitions of activities recorded was 80 [IQR 39-80]. Data about usual post stroke rehabilitation were available for 18/24 (75%). Outcome data were available for 22/24 (92%) at one month and 20/24 (83%) at three months. Outcome assessors were unblinded to participant group allocation for 11/22 (50%) at one month and 6/20 (30%) at three months. Four adverse events were considered serious as they resulted in hospitalisation. None were related to study treatment. Feedback from patients and local NHS therapists about the RFTP programme was mainly positive. Conclusions A multi-centre randomised controlled trial to evaluate an upper limb RFTP therapy programme provided early after stroke is feasible and acceptable to patients and therapists, but there are issues which needed to be addressed when designing a Phase III study. A Phase III study will need to monitor and report not only recruitment and attrition but also adherence to the intervention, usual post stroke rehabilitation received, and outcome assessor blinding

Longitudinal monitoring of Ehrlichia ruminantium infection in Gambian lambs and kids by pCS20 PCR and MAP1-B ELISA

<p>Abstract</p> <p>Background</p> <p>The epidemiology of <it>E. ruminantium </it>infection in extensively managed young animals is not adequately understood. Thus in this study, we monitored the onset (age at first infection) and kinetics of <it>E. ruminantium </it>infection and antibody response in extensively managed newborn lambs and kids at three sites in The Gambia.</p> <p>Methods</p> <p>We used a nested pCS20 PCR and MAP1-B ELISA in a longitudinal study to monitor the onset (age at first infection) and kinetics of <it>E. ruminantium </it>infection and antibody response respectively, in 77 newborn lambs and kids under a traditional husbandry system at three sites (Kerr Seringe, Keneba, Bansang) in The Gambia where heartwater is known to occur. The animals were monitored for field tick infestation and the comparative performance of the two assays in detecting <it>E. ruminantium </it>infection was also assessed.</p> <p>Results</p> <p>The infection rate detected by pCS20 PCR varied between 8.6% and 54.8% over the 162-day study period. Nineteen per cent of the animals in week 1 post-partum tested positive by pCS20 PCR with half of these infections (7/14) detected in the first 3 days after birth, suggesting that transmission other than by tick feeding had played a role. The earliest detectable <it>A. variegatum </it>infestation in the animals occurred in week 16 after birth. Antibodies detected by MAP1-B ELISA also varied, between 11.5% and 90%. Although there is considerable evidence that this assay can detect false positives and due to this and other reasons serology is not a reliable predictor of infection at least for heartwater. In contrast to the pCS20 PCR, the serological assay detected the highest proportion of positive animals in week 1 with a gradual decline in seropositivity with increasing age. The pCS20 PCR detected higher <it>E. ruminantium </it>prevalence in the animals with increasing age and both the Spearman's rank test (<it>r</it>_{<it>s </it>}= -0.1512; P = 0.003) and <it>kappa </it>statistic (-0.091 to 0.223) showed a low degree of agreement between the two assays.</p> <p>Conclusion</p> <p>The use of pCS20 PCR supported by transmission studies and clinical data could provide more accurate information on heartwater epidemiology in endemic areas and single-occasion testing of an animal may not reveal its true infection status. The view is supported because both the vector and vertical transmission may play a vital role in the epidemiology of heartwater in young small ruminants; the age range of 4 and 12 weeks corresponds to the period of increased susceptibility to heartwater in traditionally managed small ruminants.</p

Attitudes toward integrative paediatrics: a national survey among youth health are physicians in the Netherlands

<p>Abstract</p> <p>Background</p> <p>Integrative Medicine (IM) is an emerging field in paediatrics, especially in the USA. The purpose of the present study was to assess the attitudes and beliefs of Youth Health Care (YHC) physicians in the Netherlands toward IM in paediatrics.</p> <p>Methods</p> <p>In October 2010, a link to an anonymous, self-reporting, 30-item web-based questionnaire was mailed to all members of the Dutch Organisation of YHC physicians. The questionnaire included questions on familiarity with IM, attitudes towards Integrative Paediatrics (IP), use and knowledge of Complementary and Alternative Medicine (CAM), demographic and practice characteristics.</p> <p>Results</p> <p>A total of 276 YHC physicians (response rate of 27%) responded to the survey. Of the respondents, 52% was familiar with IM and 56% had used some kind of CAM therapy during the past 2 years, of which self-medicated herbal and/or homeopathic remedies (61%) and supplements (50%) were most frequently mentioned. Most of the YHC physicians (62%) seldom asked parents of clients about CAM use. One third of the YHC physicians recommended CAM to their clients. In general, about 50% or more of the respondents had little knowledge of CAM therapies. Predictors for a positive attitude towards IP were familiarity with IM, own CAM use, asking their clients about CAM use and practising one or more forms of CAM therapy. Logistic regression analysis showed that the following factors were associated with a higher recommendation to CAM therapies: own CAM use (odds ratio (OR) = 3.8; 95% confidence interval (CI) = 2.1-6.9, <it>p </it>= 0.001) and practising CAM (OR 4.4; 95% CI = 1.6-11.7, <it>p </it>= 0.003).</p> <p>Conclusions</p> <p>In general Dutch YHC physicians have a relative positive attitude towards IP; more than half of the respondents used one or more forms of CAM and one third recommended CAM therapies. However, the majority of YHC physicians did not ask their clients about CAM use and seemed to have a lack of knowledge regarding CAM.</p

Internet-based, culturally sensitive, problem-solving therapy for turkish migrants with depression: Randomized controlled trial

Background: Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. Objective: The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. Methods: A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen's d was used to determine the between-groups effect size at posttreatment and follow-up. Results: Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). Conclusions: The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. © Burçin Ünlü Ince, Pim Cuijpers, Edith van 't Hof, Wouter van Ballegooijen, Helen Christensen, Heleen Riper

Comparison of embedded and added motor imagery training in patients after stroke: Study protocol of a randomised controlled pilot trial using a mixed methods approach

Copyright @ 2009 Schuster et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Two different approaches have been adopted when applying motor imagery (MI) to stroke patients. MI can be conducted either added to conventional physiotherapy or integrated within therapy sessions. The proposed study aims to compare the efficacy of embedded MI to an added MI intervention. Evidence from pilot studies reported in the literature suggests that both approaches can improve performance of a complex motor skill involving whole body movements, however, it remains to be demonstrated, which is the more effective one.Methods/Design: A single blinded, randomised controlled trial (RCT) with a pre-post intervention design will be carried out. The study design includes two experimental groups and a control group (CG). Both experimental groups (EG1, EG2) will receive physical practice of a clinical relevant motor task ('Going down, laying on the floor, and getting up again') over a two week intervention period: EG1 with embedded MI training, EG2 with MI training added after physiotherapy. The CG will receive standard physiotherapy intervention and an additional control intervention not related to MI.The primary study outcome is the time difference to perform the task from pre to post-intervention. Secondary outcomes include level of help needed, stages of motor task completion, degree of motor impairment, balance ability, fear of falling measure, motivation score, and motor imagery ability score. Four data collection points are proposed: twice during baseline phase, once following the intervention period, and once after a two week follow up. A nested qualitative part should add an important insight into patients' experience and attitudes towards MI. Semi-structured interviews of six to ten patients, who participate in the RCT, will be conducted to investigate patients' previous experience with MI and their expectations towards the MI intervention in the study. Patients will be interviewed prior and after the intervention period.Discussion: Results will determine whether embedded MI is superior to added MI. Findings of the semi-structured interviews will help to integrate patient's expectations of MI interventions in the design of research studies to improve practical applicability using MI as an adjunct therapy technique

Effectiveness and cost-effectiveness of an exposure-based return-to-work programme for patients on sick leave due to common mental disorders: design of a cluster-randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>To reduce the duration of sick leave and loss of productivity due to common mental disorders (CMDs), we developed a return-to-work programme to be provided by occupational physicians (OPs) based on the principles of exposure in vivo (RTW-E programme). This study evaluates this programme's effectiveness and cost-effectiveness by comparing it with care as usual (CAU). The three research questions we have are: 1) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders, compared with care as usual? 2) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders? 3) From a societal perspective, is an RTW-E programme cost-effective compared with care as usual?</p> <p>Methods/design</p> <p>This study was designed as a pragmatic cluster-randomized controlled trial with a one-year follow-up and randomization on the level of OPs. We aimed for 60 OPs in order to include 200 patients. Patients in the intervention group received the RTW-E programme. Patients in the control group received care as usual. Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks. As primary outcome measures, we calculated the time until full return to work and the duration of sick leave. Secondary outcome measures were time until partial return to work, prevalence rate of sick leave at 3, 6, 9, and 12 months' follow-up, and scores of symptoms of distress, anxiety, depression, somatization, and fatigue; work capacity; perceived working conditions; self-efficacy for return to work; coping behaviour; avoidance behaviour; patient satisfaction; and work adaptations. As process measures, we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups. Economic costs were calculated from a societal perspective. The total costs consisted of the costs of consuming health care, costs of production loss due to sick leave and reduced productivity, and out-of-pocket costs of patients for travelling to their OP.</p> <p>Discussion</p> <p>The results will be published in 2009. The strengths and weaknesses of the study protocol are discussed.</p> <p>Trial registration</p> <p>ISRCTN72643128</p

Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial

Background. Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual. Methods/design. The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC) or care as usual (CAU). In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1) guided self-help, 2) cognitive behavioral therapy and 3) antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI). Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. Discussion. It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options for GAD and PD in the primary care setting. Results will become available in 2011. Trial registration. NTR1071

Can Survival Prediction Be Improved By Merging Gene Expression Data Sets?

BACKGROUND:High-throughput gene expression profiling technologies generating a wealth of data, are increasingly used for characterization of tumor biopsies for clinical trials. By applying machine learning algorithms to such clinically documented data sets, one hopes to improve tumor diagnosis, prognosis, as well as prediction of treatment response. However, the limited number of patients enrolled in a single trial study limits the power of machine learning approaches due to over-fitting. One could partially overcome this limitation by merging data from different studies. Nevertheless, such data sets differ from each other with regard to technical biases, patient selection criteria and follow-up treatment. It is therefore not clear at all whether the advantage of increased sample size outweighs the disadvantage of higher heterogeneity of merged data sets. Here, we present a systematic study to answer this question specifically for breast cancer data sets. We use survival prediction based on Cox regression as an assay to measure the added value of merged data sets. RESULTS:Using time-dependent Receiver Operating Characteristic-Area Under the Curve (ROC-AUC) and hazard ratio as performance measures, we see in overall no significant improvement or deterioration of survival prediction with merged data sets as compared to individual data sets. This apparently was due to the fact that a few genes with strong prognostic power were not available on all microarray platforms and thus were not retained in the merged data sets. Surprisingly, we found that the overall best performance was achieved with a single-gene predictor consisting of CYB5D1. CONCLUSIONS:Merging did not deteriorate performance on average despite (a) The diversity of microarray platforms used. (b) The heterogeneity of patients cohorts. (c) The heterogeneity of breast cancer disease. (d) Substantial variation of time to death or relapse. (e) The reduced number of genes in the merged data sets. Predictors derived from the merged data sets were more robust, consistent and reproducible across microarray platforms. Moreover, merging data sets from different studies helps to better understand the biases of individual studies and can lead to the identification of strong survival factors like CYB5D1 expression

Vegan diets : practical advice for athletes and exercisers.

With the growth of social media as a platform to share information, veganism is becoming more visible, and could be becoming more accepted in sports and in the health and fitness industry. However, to date, there appears to be a lack of literature that discusses how to manage vegan diets for athletic purposes. This article attempted to review literature in order to provide recommendations for how to construct a vegan diet for athletes and exercisers. While little data could be found in the sports nutrition literature specifically, it was revealed elsewhere that veganism creates challenges that need to be accounted for when designing a nutritious diet. This included the sufficiency of energy and protein; the adequacy of vitamin B12, iron, zinc, calcium, iodine and vitamin D; and the lack of the long-chain n-3 fatty acids EPA and DHA in most plant-based sources. However, via the strategic management of food and appropriate supplementation, it is the contention of this article that a nutritive vegan diet can be designed to achieve the dietary needs of most athletes satisfactorily. Further, it was suggested here that creatine and β-alanine supplementation might be of particular use to vegan athletes, owing to vegetarian diets promoting lower muscle creatine and lower muscle carnosine levels in consumers. Empirical research is needed to examine the effects of vegan diets in athletic populations however, especially if this movement grows in popularity, to ensure that the health and performance of athletic vegans is optimised in accordance with developments in sports nutrition knowledge