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Background: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective.Methods: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap.Results: Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold.Conclusions: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic.Trial Registration: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility of a Dance Centre delivering a programme of mixed dances to people with Parkinson's and identify suitable outcomes for a future definitive trial. Design: A two-group randomized controlled feasibility trial. Methods: People with Parkinson's were randomized to a control or experimental group (ratio 15:35), alongside usual care. In addition, participants in the experimental group danced with a partner for one hour, twice-a-week for 10 weeks; professional dance teachers led the classes and field-notes were kept. Control-group participants were given dance class vouchers at the end of the study. Blinded assessments of balance, mobility and function were completed in the home. Qualitative interviews were conducted with a subsample to explore the acceptability of dance. Results: A total of 51 people with Parkinson's (25 male) with Hoehn and Yahr scores of 1-3 and mean age of 71 years (range 49-85 years), were recruited to the study. Dance partners were of similar age (mean 68, range 56-91 years). Feasibility findings focused on recruitment (target achieved); retention (five people dropped out of dancing); outcome measures (three measures were considered feasible, changes were recommended). Proposed sample size for a Phase III trial, based on the 6-minute walk test at six months was 220. Participants described dance as extremely enjoyable and the instructors were skilled in instilling confidence and motivation. The main organizational challenges for a future trial were transport and identifying suitable dance partners. Conclusion: We have demonstrated the feasibility of conducting the study through a Dance Centre and recommend a Phase III trial. [ABSTRACT FROM AUTHOR]

Graphical sensitivity analyses have recently been recommended for clinical trials with non-ignorable missing outcome. We demonstrate an adaptation of this methodology for a continuous outcome of a trial of three cognitive-behavioural therapies for mild depression in primary care, in which one arm had unexpectedly high levels of missing data. Fixed-value and multiple imputations from a normal distribution (assuming either varying mean and fixed standard deviation, or fixed mean and varying standard deviation) were used to obtain contour plots of the contrast estimates with their P-values superimposed, their confidence intervals, and the root mean square errors. Imputation was based either on the outcome value alone, or on change from baseline. The plots showed fixed-value imputation to be more sensitive than imputing from a normal distribution, but the normally distributed imputations were subject to sampling noise. The contours of the sensitivity plots were close to linear in appearance, with the slope approximately equal to the ratio of the proportions of subjects with missing data in each trial arm. [ABSTRACT FROM AUTHOR]

Background: The risk of people with Parkinson's disease (PD) falling is greater than that of the general population but to date, disease-specific predictors of falling have not been identified.Objectives: To identify one or more features, which would predict individuals at risk of falling during a 3-month prospective follow-up study.Method: A battery of standardised tests administered in the home and the laboratory with a 3-month follow-up telephone interview.Results: Sixty-three people with PD were recruited from GP practices. Eleven interview variables and six gait laboratory variables were used with subsamples (55 and 44 subjects, respectively) to fit predictive models for identifying future fallers. The number of falls in the previous year was the most important variable, without exception, to be selected as a predictor in various logistic regression models. A history of two or more falls had a sensitivity of 86.4% (95% CI 67.3-96.2%) and a specificity of 85.7% (95% CI 71.2-94.2%) in predicting falling in the next 3 months.Conclusion: Healthcare workers should be asking their patients with PD regularly and carefully about falling, and should consider instigating programmes of fall management for patients with PD who have fallen two or more times in the previous 12 months. [ABSTRACT FROM AUTHOR]

Sertindole (Serdolect), an atypical antipsychotic, was voluntarily suspended in the European Union in 1998 following regulatory concerns over reports of serious cardiac dysrhythmias and sudden unexpected deaths. The reported causes of death, their frequency, prolongation of the rate corrected QT interval (QTc) and cardiac dysrhythmias in patients prescribed sertindole were compared with those for patients treated with two other atypical antipsychotics. All patients in England, prescribed atypical antipsychotics by general practitioners during each drug's immediate post-marketing period, were identified using an observational cohort technique, prescription-event monitoring. Mortality rates in the sertindole cohort were compared with those in a comparator cohort using standardized mortality ratios and incidence rate ratios. Cardiovascular events were reviewed and followed up to identify cases of prolongation of QTc interval. There was no statistically significant difference in mortality rates between sertindole and the comparator cohort, although confidence intervals (CI) were wide due to small numbers in the sertindole cohort. A much smaller number of patients were prescribed sertindole than the other antipsychotics. Six cases of prolongation of QTc interval were identified in 462 patients (1.3%, 95% CI 0.5-2.8) treated with sertindole and one with unspecified electrocardiogram changes in the comparator cohort of 16,542 patients. This study contributes to the understanding of the occurrence of prolongation of QTc interval during clinical use of sertindole, the incidence of which was similar to that in clinical trials. Although no statistically significant difference was shown in mortality rates between sertindole and comparator cohort, the sertindole cohort was too small to rule out an association between the use of this drug and cardiovascular deaths. [ABSTRACT FROM AUTHOR]

This paper examines secular changes in the influence of maternal age, parity and social class on perinatal mortality in Scotland. Despite changes in reproductive behaviour, improved access to maternity services and more effective perinatal care, the influence of maternal age and social class on perinatal mortality remained unchanged between 1960 and 1982. Although there were no significant changes in the traditional J-shaped association between parity and stillbirths, cross-sectional analysis shows that in the early 1980s the risk of both neonatal and perinatal deaths decreased as parity increased: this finding is consistent with the pattern of risks observed in longitudinal studies and retrospective surveys of reproductive histories. The stability of age, parity and social class effects thus suggests that little if any of the overall decrease in Scottish perinatal mortality can be attributed to a significant narrowing of relative risks in the obstetric population. [ABSTRACT FROM PUBLISHER]

OBJECTIVES--To assess the diagnostic yield, sampling errors, risks, and therapeutic implications of right ventricular endomyocardial biopsy in children with suspected or possible myocarditis. DESIGN--Retrospective study. SETTING--Tertiary referral centre for paediatric cardiology, cardiac surgery, heart transplantation, and mechanical circulatory support. PATIENTS AND METHODS--Review of clinical and histological findings among 63 consecutive children with possible myocarditis undergoing right ventricular endomyocardial biopsy. Review of cardiac histology at subsequent necropsy or after explantation at time of transplantation. RESULTS--From January 1980 to December 1992, 76 biopsies were performed in 63 children (2 weeks to 18 years of age). In 41 cases, the biopsy was performed for evaluation of dilated cardiomyopathy. The median interval from onset of symptoms was one month. Eight children (20%; all with a history of less than six weeks duration) had biopsy proved myocarditis. Five of the eight children made a full recovery, including four who presented in cardiogenic shock. By contrast, only three of 33 children without evidence of myocarditis showed recovery of ventricular function. The whole heart was available for histological examination in 23 patients. Myocarditis was confirmed in one patient, and no evidence of myocarditis was found in the remaining 22 (all with negative biopsies). One procedure related death occurred in a 2 week old infant with dilated cardiomyopathy. In 22 cases, biopsy was performed for the evaluation of arrhythmia. Only one biopsy showed myocarditis. CONCLUSIONS--The diagnostic yield of a biopsy is low in children with arrhythmias. In children presenting with profound ventricular dysfunction, a diagnosis of acute myocarditis may avoid premature consideration of transplantation as this group has an important potential for full recovery. In less critically ill patients and in those with a longer duration of symptoms the justification for biopsy is not as clear and the procedure is not without risk. [ABSTRACT FROM PUBLISHER]

Presents an abstract of the article "Referrals to Clinical Genetics Services: GPs' Attitudes and Practice," by Greta Westwood, P. Little, R.M. Pickering, I.K. Temple, S.M. Latter, and A.M. Lucassen.

Objective: To systematically review the methodology in particular treatment options and outcomes and the effect of multiple sessions of transcranial direct current stimulation (tDCS) with rehabilitation programmes for upper extremity recovery post stroke. Methods: A search was conducted for randomised controlled trials involving tDCS and rehabilitation for the upper extremity in stroke. Quality of included studies was analysed using the Modified Downs and Black form. The extent of, and effect of variation in treatment parameters such as anodal, cathodal and bi-hemispheric tDCS on upper extremity outcome measures of impairment and activity were analysed using meta-analysis. Results: Nine studies (371 participants with acute, sub-acute and chronic stroke) were included. Different methodologies of tDCS and upper extremity intervention, outcome measures and timing of assessments were identified. Real tDCS combined with rehabilitation had a small non-significant effect of +0.11 (p = 0.44) and +0.24 (p = 0.11) on upper extremity impairments and activities at post-intervention respectively. Conclusion: Various tDCS methods have been used in stroke rehabilitation. The evidence so far is not statistically significant, but is suggestive of, at best, a small beneficial effect on upper extremity impairment. [ABSTRACT FROM AUTHOR]

Objective: To systematically review the methodology in particular treatment options and outcomes and the effect of multiple sessions of transcranial direct current stimulation (tDCS) with rehabilitation programmes for upper extremity recovery post stroke., Methods: A search was conducted for randomised controlled trials involving tDCS and rehabilitation for the upper extremity in stroke. Quality of included studies was analysed using the Modified Downs and Black form. The extent of, and effect of variation in treatment parameters such as anodal, cathodal and bi-hemispheric tDCS on upper extremity outcome measures of impairment and activity were analysed using meta-analysis., Results: Nine studies (371 participants with acute, sub-acute and chronic stroke) were included. Different methodologies of tDCS and upper extremity intervention, outcome measures and timing of assessments were identified. Real tDCS combined with rehabilitation had a small non-significant effect of +0.11 (p=0.44) and +0.24 (p=0.11) on upper extremity impairments and activities at post-intervention respectively., Conclusion: Various tDCS methods have been used in stroke rehabilitation. The evidence so far is not statistically significant, but is suggestive of, at best, a small beneficial effect on upper extremity impairment., Significance: Future research should focus on which patients and rehabilitation programmes are likely to respond to different tDCS regimes., (Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Turning round is a routine everyday activity that can often lead to instability. The purpose of this study was to investigate abnormalities of turning among people with Parkinson's disease (PwPD) through the measurement of sequence of body segments and latency response. Participants were asked to turn 180° and whole-body movements were recorded using CODAmotion and Visio Fast eye tracking equipment. Thirty-one independently mobile PwPD and 15 age-matched healthy controls participated in the study. We found that contrary to common belief, the head preceded movement of all other body segments (eyes, shoulders, pelvis, first and second foot). We also found interaction between group and body segment (P=0.005), indicating that overall, PwPD took longer to move from head to second foot than age-matched healthy controls. For PwPD only, interactions were found between disease severity and body segment (P<0.0001), between age group and body segment (P<0.0001) and between gender and body segments (P<0.0001). For each interaction, longer time periods were noted between moving the first foot after the pelvis, and moving the second foot after the first, and this was noted for PwPD in Hoehn and Yahr stage III-IV (in comparison to Hoehn and Yahr stage I-II); for PwPD who were under 70 years (in comparison with 70 years or over); and for ladies (in comparison with men). Our results indicate that in PwPD and healthy elderly, turning-on-the-spot might not follow the top-to-bottom approach we know from previous research., (Copyright © 2013. Published by Elsevier B.V.)