Siobhan Creanor

Risk factors for falls in multiple sclerosis: an observational study.

Background: People with multiple sclerosis (MS) experience frequent falls, which are associated with impairments and limitations to activities and participations. Objective: The objective of this paper is to evaluate falls risk factors using robust clinical measures. Methods: A total of 150 individuals (confirmed MS diagnosis, Expanded Disability Status Scale (EDSS) 3.5–6.5) were recruited, with 148 participants included in the final analysis. Demographic data were collected and performance assessed in eight predictor measures (Physiological Profile Assessment (PPA), Brief Ataxia Rating scale, Ashworth scale (Ashworth), Modified Falls Efficacy scale, Symbol Digit Modalities Test, dual-task interference, lying/standing blood pressure, static/dynamic visual acuity). Participants prospectively recorded falls over three months using a daily diary. People were classified as “fallers” based on reports of ≥ two falls. Results: A total of 104 participants recorded 672 falls; 78 (52.7%) reported ≥ two falls. Continence issues, previous falls history and use of prescribed medications were each associated with increased risk of being a “faller”. Ashworth and PPA risk score contributed significantly to a logistic regression model predicting faller/non-faller classification. The reduced model (Ashworth, PPA, EDSS) showed fair-to-good predictive ability (ROC c-statistic 0.73, sensitivity 70%, specificity 69%). Conclusion: This study confirms the high prevalence of falls in ambulant people with MS. Important potentially modifiable risk factors are identified, suggesting aspects to target in falls interventions.

Effectiveness of a gentamicin impregnated collagen sponge on reducing sternal wound infections following cardiac surgery: a meta-analysis of randomised controlled trials

INTRODUCTION Gentamicin impregnated collagen sponges are licensed for use after cardiac surgery in over 50 countries but their effectiveness at preventing sternal wound infections (SWIs) remains uncertain. The aim of this meta-analysis was to assess the current evidence for effectiveness of such sponges at preventing SWIs in patients after cardiac surgery. METHODS A systematic search of the literature was undertaken and meta-analyses were performed on the results of the identified, eligible studies. Using random effects models, odds ratios (OR) and corresponding 95% confidence intervals (Cl) were calculated for all SWIs and deep SWIs for: a) all participants, and b) participants deemed as high risk. RESULTS Three unique randomised controlled trials (published between 2005 and 2010) involving 3,994 participants met the inclusion criteria. There was insufficient evidence of a significant difference between intervention and control groups for all SWIs (all participants: OR: 0.66, 95% Cl: 0.39–1.14; high risk participants: OR: 0.60, 95% Cl: 0.24–1.52). There was insufficient evidence of a significant benefit of the sponge in deep SWIs across all participants (OR: 0.72, 95% Cl: 0.47–1.10) but some evidence of benefit in terms of reducing the incidence of deep SWIs in high risk participants (OR: 0.62, 95% Cl: 0.39–0.98). CONCLUSIONS There is insufficient evidence of the effectiveness (or otherwise) of gentamicin impregnated sponges in preventing SWIs following cardiac surgery. However, some evidence does exist that such sponges can reduce the incidence of deep infections in high risk patients.

PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with non-traumatic abdominal pain: randomised trial

Objective To determine whether patient controlled analgesia (PCA) is better than routine care in providing effective analgesia for patients presenting to emergency departments with moderate to severe non-traumatic abdominal pain. Design Pragmatic, multicentre, parallel group, randomised controlled trial Setting Five English hospitals. Participants 200 adults (66% (n=130) female), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe non-traumatic abdominal pain and were expected to be admitted to hospital for at least 12 hours. Interventions Patient controlled analgesia or nurse titrated analgesia (treatment as usual). Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate or severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. Results 196 participants were included in the primary analyses (99 allocated to PCA and 97 to treatment as usual). Mean total pain experienced was 35.3 (SD 25.8) in the PCA group compared with 47.3 (24.7) in the treatment as usual group. The adjusted between group difference was 6.3 (95% confidence interval 0.7 to 11.9). Participants in the PCA group received significantly more morphine (mean 36.1 (SD 22.4) v 23.6 (13.1) mg; mean difference 12.3 (95% confidence interval 7.2 to 17.4) mg), spent less of the study period in moderate or severe pain (32.6% v 46.9%; mean difference 14.5% (5.6% to 23.5%)), and were more likely to be perfectly or very satisfied with the management of their pain (83% (73/88) v 66% (57/87); adjusted odds ratio 2.56 (1.25 to 5.23)) in comparison with participants in the treatment as usual group. Conclusions Significant reductions in pain can be achieved by PCA compared with treatment as usual in patients presenting to the emergency department with non-traumatic abdominal pain. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.

Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial.

Background Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. Objectives The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. Methods A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). Results One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=−0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. Limitations In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Conclusion Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation.

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial

Summary Background Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months. Methods This pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9–10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete. Findings Between March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention–control) at 24 months was −0·02 (95% CI −0·09 to 0·05), p=0·57. One parent reported an adverse event related to their childs eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator. Interpretation Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches. Funding UK National Institute for Health Research, Public Health Research Programme.

The cost-effectiveness of patient-controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital

The clinical effectiveness of patient‐controlled analgesia has been demonstrated in a variety of settings. However, patient‐controlled analgesia is rarely utilised in the Emergency Department. The aim of this study was to compare the cost‐effectiveness of patient‐controlled analgesia vs. standard care in participants admitted to hospital from the Emergency Department with pain due to traumatic injury or non‐traumatic abdominal pain. Pain scores were measured hourly for 12 h using a visual analogue scale. Cost‐effectiveness was measured as the additional cost per hour in moderate to severe pain avoided by using patient‐controlled analgesia rather than standard care (the incremental cost‐effectiveness ratio). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. The cost per hour in moderate or severe pain averted was estimated as £24.77 (€29.05, US

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children

30.80) (bootstrap estimated 95%CI £8.72 to £89.17) for participants suffering pain from traumatic injuries and £15.17 (€17.79, US

Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

18.86) (bootstrap estimate 95%CI £9.03 to £46.00) for participants with non‐traumatic abdominal pain. Overall costs were higher with patient‐controlled analgesia than standard care in both groups: pain from traumatic injuries incurred an additional £18.58 (€21.79 US

Physical activity and the prevention, reduction, and treatment of alcohol and/or substance use across the lifespan (The PHASE review): protocol for a systematic review

23.10) (95%CI £15.81 to £21.35) per 12 h; and non‐traumatic abdominal pain an additional £20.18 (€23.67 US

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

25.09) (95%CI £19.45 to £20.84) per 12 h.