Medical encounters at community-based physical activity events (parkrun) in the UK.

OBJECTIVE: To determine the incidence, clinical correlates and exposure risk of medical encounters during community-based physical activity events in the UK. METHODS: An analysis of medical data from weekly, community-based physical activity events (parkrun) at 702 UK locations over a 6-year period (29 476 294 participations between 2014 and 2019) was conducted in order to define the incidence and clinical correlates of serious life-threatening, non-life-threatening and fatal medical encounters. RESULTS: 84 serious life-threatening encounters (overall incidence rate=0.26/100 000 participations) occurred including 18 fatalities (0.056/100 000 participations). Statistical modelling revealed that the probabilities of serious life-threatening encounters were exceptionally low, however, male sex, increasing age, slower personal best parkrun time and less prior running engagement/experience (average number of runs per year and number of years as a parkrun participant) were associated with increased probability of serious life-threatening encounters. These were largely accounted for by cardiac arrest (48/84, 57%) and acute coronary syndromes (20/84, 24%). Non-life-threatening medical encounters were mainly attributed to tripping or falling, with a reported incidence of 39.2/100 000 participations. CONCLUSIONS: Serious life-threatening and fatal medical encounters associated with parkrun participation are extremely rare. In the context of a global public health crisis due to inactivity, this finding underscores the safety and corollary public health value of community running/walking events as a strategy to promote physical activity.

Analysis of revascularisation in ischaemic stroke with EmboTrap (ARISE I study) and meta-analysis of thrombectomy.

BACKGROUND AND PURPOSE: The goal of the analysis of revascularisation in ischaemic stroke with EmboTrap study (ARISE I) was to demonstrate the effectiveness of EmboTrap. METHODS: ARISE I was an open label, single arm, multicentre, prospective study for the treatment of acute stroke due to large vessel occlusion. The primary outcome was revascularisation of the target vessel as measured by the modified thrombolysis in cerebrovascular infarction (mTICI) score of at least 2b following thrombectomy with EmboTrap. For comparison of the ARISE I results a meta-analysis of eight randomised controlled trials was performed. RESULTS: ARISE I enrolled 40 patients. Their baseline characteristics that are predictors of stroke outcome and procedure timings in ARISE I were similar to those reported in recent randomised controlled trials. The primary outcome, good revascularisation rates (mTICI 2b/3 scores) after three or fewer passes with EmboTrap were 75% (95% confidence interval (CI) 62-88%), which is the same as 74% found in randomised controlled trials (difference of 0.8%, P = 0.95). After additional EmboTrap passes or the use of another device mTICI 2b/3 scores rose to 85% (95% CI 74-96%), which was also similar to the randomised controlled trials (difference 11%, P = 0.38). The high revascularisation rates in ARISE I converted into 64% good clinical outcomes (modified Rankin scale ≤2) compared to 50% in randomised controlled trials (difference 14%; 95% CI -13.7-41.7%; P = 0.32). CONCLUSIONS: ARISE I demonstrates that thrombectomy using the EmboTrap stent retriever yields similar results to devices that were used in recent randomised controlled trials for the treatment of stroke due to large vessel occlusions. ClinicalTrials.gov identifier NCT02190552.

Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.

OBJECTIVE: To investigate feasibility of multiple sclerosis (MS) exercise guidelines for inactive people with MS (PwMS) and to examine preliminary efficacy for walking. To investigate effect of augmenting that intervention with education based on social cognitive theory (SCT). DESIGN: Pilot multicentre, double-blind, randomised, parallel, controlled trial. SETTING: Community-delivered programme. PARTICIPANTS: Sixty-five physically inactive PwMS walked independently, scored 0-3 on the Patient Determined Disease Steps Scale, had no MS relapse or change in MS medication in 12 weeks. INTERVENTIONS: 10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON). OUTCOME MEASURES: Six-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12). RESULTS: 174 expressed interest, 92 were eligible and 65 enrolled (SCT, n=32; CON, n=33). The intervention was feasible and delivered as intended. 68% of SCT group and 50% of control group met the exercise guidelines after intervention. Using linear mixed effects models, intention-to-treat basis, there was insufficient evidence for difference between the groups over the trial (6MWT, p=0.30; TUG, p=0.4; MSWS-12, p=0.8). Using secondary analysis of a cohort with data for≥3 assessments (SCT, n=21; CON, n=20), there was significant treatment effect favouring the intervention group (p=0.04) with mean effect for 6MWT 39.0 m (95% CI 2.26 to 75.73) at 12 weeks and 40.0 m (95% CI 2.3 to 77.8) at 36 weeks. Both groups improved significantly in 6MWT following 10-week intervention (SCT, mean ∆=83.02, SD=60.1, p≤0.01; CON, mean ∆=56.92, SD=73.5, p≤0.01), TUG (SCT, ∆=-0.70, SD=1.25, p≤0.01; CON, ∆=-0.54, SD=0.95, p≤0.01) and MSWS-12 (SCT, ∆=-8.03, SD=16.18, p=0.02; CON, ∆=-0.86, SD=18.74, p=0.81). CONCLUSIONS: A 10-week exercise programme based on the MS exercise guidelines for improving walking in previously inactive PwMS was feasible. There is marginal evidence of a treatment effect in favour of the exercise plus SCT intervention at 12 and 36 weeks. TRIAL REGISTRATION NUMBER: NCT02301442; Results.

Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education - secondary results of the step it up randomised controlled trial.

BACKGROUND: Recent exercise guidelines for people with multiple sclerosis (MS) recommend a minimum of 30 min moderate intensity aerobic exercise and resistance exercise twice per week. This trial compared the secondary outcomes of a combined 10-week guideline based intervention and a Social Cognitive Theory (SCT) education programme with the same exercise intervention involving an attention control education. METHODS: Physically inactive people with MS, scoring 0-3 on Patient Determined Disease Steps Scale, with no MS relapse or change in MS medication, were randomised to 10-week exercise plus SCT education or exercise plus attention control education conditions. Outcomes included fatigue, depression, anxiety, strength, physical activity, SCT constructs and impact of MS and were measured by a blinded assessor pre and post-intervention and 3 and 6 month follow up. RESULTS: One hundred and seventy-four expressed interest, 92 were eligible and 65 enrolled. Using linear mixed effects models, the differences between groups on all secondary measures post-intervention and at follow-up were not significant. Post-hoc, exploratory, within group analysis identified improvements in both groups post intervention in fatigue (mean ∆(95% CI) SCT -4.99(-9.87, -0.21), p = 0.04, Control -7.68(-12.13, -3.23), p = 0.00), strength (SCT -1.51(-2.41, -0.60), p < 0.01, Control -1.55(-2.30, -0.79), p < 0.01), physical activity (SCT 9.85(5.45, 14.23), p < 0.01, Control 12.92(4.69, 20.89), goal setting (SCT 7.30(4.19, 10.4), p < 0.01, Control 5.96(2.92, 9.01), p < 0.01) and exercise planning (SCT 5.88(3.37, 8.39), p < 0.01, Control 3.76(1.27, 6.25), p < 0.01) that were maintained above baseline at 3 and 6 month follow up (all p < 0.05). Only the SCT group improved at 3 and 6 month follow up in physical impact of MS(-4.45(-8.68, -0.22), -4.12(-8.25, 0.01), anxiety(-1.76(-3.20, -0.31), -1.99(-3.28, -0.71), depression(-1.51(-2.89, -0.13), -1.02(-2.05, 0.01)) and cognition(5.04(2.51, 7.57), 3.05(0.81, 5.28), with a medium effect for cognition and fitness (Hedges' g 0.75(0.24, 1.25), 0.51(0.01, 1.00) at 3 month follow up. CONCLUSIONS: There were no statistically significant differences between groups for the secondary outcomes once age, gender, time since diagnosis and type of MS were accounted for. However, within the SCT group only there were improvements in anxiety, depression, cognition and physical impact of MS. Exercising at the minimum guideline amount has a positive effect on fatigue, strength and PA that is sustained at 3 and 6 months following the cessation of the program. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02301442 , retrospectively registered on November 13th 2014.

Summarising censored survival data using the mean residual life function.

The mean residual life function provides a clear and simple summary of the effect of a treatment or a risk factor in units of time, avoiding hazard ratios or probability scales, which require careful interpretation. Estimation of the mean residual life is complicated by the upper tail of the survival distribution not being observed as, for example, patients may still be alive at the end of the follow-up period. Various approaches have been developed to estimate the mean residual life in the presence of such right censoring. In this work, a novel semi-parametric method that combines existing non-parametric methods and an extreme value tail model is presented, where the limited sample information in the tail (prior to study termination) is used to estimate the upper tail behaviour. This approach will be demonstrated with simulated and real-life examples.

Forearm oxygenation and blood flow kinetics during a sustained contraction in multiple ability groups of rock climbers.

Currently, the physiological mechanisms that allow elite level climbers to maintain intense isometric contractions for prolonged periods of time are unknown. Furthermore, it is unclear whether blood flow or muscle oxidative capacity best governs performance. This study aimed to determine the haemodynamic kinetics of 2 forearm flexor muscles in 3 ability groups of rock climbers. Thirty-eight male participants performed a sustained contraction at 40% of maximal voluntary contraction (MVC) until volitional fatigue. Oxygen saturation and blood flow was assessed using near infrared spectroscopy and Doppler ultrasound. Compared to control, intermediate, and advanced groups, the elite climbers had a significantly (P < 0.05) higher strength-to-weight ratio (MVC/N), de-oxygenated the flexor digitorum profundus significantly (P < 0.05) more (32, 34.3, and 42.8 vs. 63% O2, respectively), and at a greater rate (0.32, 0.27, and 0.34 vs. 0.77 O2%·s(-1), respectively). Furthermore, elite climbers de-oxygenated the flexor carpi radialis significantly (P < 0.05) more and at a greater rate than the intermediate group (36.5 vs. 14.6% O2 and 0.43 vs. 0.1O2%·s(-1), respectively). However, there were no significant differences in total forearm ∆ blood flow. An increased MVC/N is not associated with greater blood flow occlusion in elite climbers; therefore, oxidative capacity may be more important for governing performance.

Changes in acute biochemical markers of inflammatory and structural stress in rugby union.

Rugby union is a sport governed by the impacts of high force and high frequency. Analysis of physiological markers following a game can provide an understanding of the physiological response of an individual and the time course changes in response to recovery. Urine and saliva were collected from 11 elite amateur rugby players 24 h before, immediately after, and at 17, 25, 38, 62 and 86 h post-game. Myoglobin, salivary immunoglobulin A and cortisol were analysed by ELISA, whereas neopterin and total neopterin were analysed by high-performance liquid chromatography. There was a significant post-game increase of all four markers. The increases were cortisol 4-fold, myoglobin 2.85-fold, neopterin 1.75-fold and total neopterin 2.3-fold when corrected with specific gravity. All significant changes occurred post-game only, with markers returning to and remaining at baseline within 17 h. The intensity of the game caused significant changes in key physiological markers of stress. They provide an understanding of the stress experienced during a single game of rugby and the time course changes associated with player recovery. Neopterin provides a new marker of detecting an acute inflammatory response in physical exercise, while specific gravity should be considered for urine volume correction post-exercise.

A comparison of capillary, venous, and salivary cortisol sampling after intense exercise.

UNLABELLED: Venipuncture is expensive, invasive, and impractical for many sport-science and clinical-based settings. Salivary free cortisol is often cited as a noninvasive practical alternative. However, when cortisol concentrations exceed the corticosteroid-binding globulin (CBG) point of 500 nmol/L, a lack of agreement between salivary and venous blood cortisol has been found. Alternatively, capillary blood may present a minimally invasive, cost-effective, and practical surrogate for determining cortisol concentration. PURPOSE: The aim of this study was to determine whether cortisol concentrations sampled from capillary blood and saliva accurately reflect those found in venous blood across a large range of concentrations after intense exercise. METHODS: Eleven healthy aerobically trained male subjects were recruited. Capillary, salivary, and venous blood samples were collected before and after (immediately and 5, 10, 15, and 20 min after) a treadmill VO(2) max test. RESULTS: Capillary and venous concentrations increased at a similar rate after exercise (Cohen d.14-.33), increasing up to 15 min postexercise before a decline was seen. Salivary cortisol values increased at a slower rate than venous and capillary cortisol but continued to increase 15 min postexercise (Cohen d .19-.47 and .09-.72, respectively). CONCLUSIONS: Capillary cortisol accurately reflects concentrations assayed from venous blood across a range of values below and above the CBG binding point. Capillary sampling provides a minimally invasive, cost-effective, practical surrogate for assessment of hypothalamic-pituitary-gland function.

The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial.

OBJECTIVE: To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD). DESIGN: Two-arm, cluster randomised controlled trial. SETTING: 32 general practices in the Republic of Ireland. PARTICIPANTS: 350 participants with a diagnosis of moderate or severe COPD. INTERVENTION: Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care. MAIN OUTCOME MEASURE: Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12-14 weeks postcompletion of the programme. RESULTS: Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen. CONCLUSIONS: A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD. TRIAL REGISTRATION: ISRCTN52403063.

Prediction of Oncotype DX and TAILORx risk categories using histopathological and immunohistochemical markers by classification and regression tree (CART) analysis.

Oncotype DX is an RT-PCR assay used to predict which patients with ER-positive node-negative (NN) disease will benefit from chemotherapy. Each patient is stratified into a risk category based on a recurrence score (RS) and the TAILORx trial is determining the benefit of chemotherapy for patients with mid-range RSs. We tested if Oncotype DX and TAILORx risk categories could be predicted by standard pathological features and protein markers corresponding to 10 genes in the assay (ER, PR, Ki67, HER2, BCL2, CD68, Aurora A kinase, survivin, cyclin B1 and BAG1) on 52 patients who enrolled on TAILORx. Immunohistochemistry for the protein markers was performed on whole tissue sections. Classification and regression tree (CART) analysis correctly classified 69% of cases into Oncotype DX risk categories based on the expression of PR, survivin and nuclear pleomorphism. All tumours with PR staining (Allred score ≥ 2) and marked nuclear pleomorphism were in the high-risk category. No case with PR <2, low survivin (≤ 15.5%) and nuclear pleomorphism <3 was high-risk. Similarly, 77% of cases were correctly classified into TAILORx categories based on nuclear pleomorphism, survivin, BAG1 and cyclin B1. Ki67 was the only variable that predicted the absolute RS with a cut-off for positivity of 15% (p = 0.003). In conclusion, CART revealed key predictors including proliferation markers, PR and nuclear pleomorphism that correctly classified over two thirds of ER-positive NN cancers into Oncotype DX and TAILORx risk categories. These variables could be used as an alternative to the RT-PCR assay to reduce the number of patients requiring Oncotype DX testing.

Injury survey of a non-traditional 'soft-edged' trampoline designed to lower equipment hazards.

In Australia trampolines contribute one quarter of all childhood play equipment injuries. The objective of this study was to gather and evaluate injury data from a non-traditional, 'soft-edged', consumer trampoline, where the design aimed to minimise injuries from the equipment and from falling off. The manufacturer of the non-traditional trampoline provided the University of Technology Sydney with their Australian customer database. The study involved surveys in Queensland and New South Wales, between May 2007 and March 2010. Initially injury data was gathered by a phone interview pilot study, then in the full study, through an email survey. The 3817 respondents were the carers of child users of the 'soft-edge' trampolines. Responses were compared with Australian and US emergency department data. In both countries the proportion of injuries caused by the equipment and falling off was compared with the proportion caused by the jumpers to themselves or each other. The comparisons showed a significantly lower proportion resulted from falling-off or hitting the equipment for this design when compared to traditional trampolines, both in Australia and the US. This research concludes that equipment-induced and falling-off injuries, the more severe injuries on traditional trampolines, can be significantly reduced with appropriate trampoline design.

Survey of injury sources for a trampoline with equipment hazards designed out.

AIM: In Australia, trampolines contribute approximately one-quarter of all childhood play-equipment injuries. The purpose of this study was to gather and evaluate injury data from a nontraditional, 'soft-edged', consumer trampoline in which the equipment injury sources have been designed out. METHODS: A survey was undertaken in Queensland and New South Wales. The manufacturer of the nontraditional trampoline provided the University of Technology, Sydney, with their Australian customer database. Injury data were gathered in a pilot study by phone interview, then in a full study through an email survey. Results from 3817 respondents were compared with earlier Australian and US data from traditional trampolines gathered from emergency departments. RESULTS: A significantly lower proportion of the injuries caused by falling off or striking the equipment was found for this new design when compared with traditional trampolines both in Australia and in the USA. The age of children being injured on trampolines in Australia was found to be markedly lower than in North America. CONCLUSIONS: This research indicates that with appropriate design the more severe injuries on traditional trampolines can be significantly reduced.

An exploratory investigation of some statistical summaries of oximeter oxygen saturation data from preterm babies.

Aim. To explore the potential usefulness of the mean, standard deviation (SD), and coefficient of variation (CV = SD/mean) of oximeter oxygen saturations in the clinical care of preterm babies. Methods. This was an exploratory investigation involving 31 preterm babies at 36 weeks postmenstrual age. All babies were healthy, but two were considered to be clinically unstable and required greater attention. Each baby's oxygen saturations were recorded using an oximeter and summarized by the mean, SD, and CV. The potential usefulness of each measure was assessed by its ability to distinguish the two unstable babies from the others. This was achieved using box plots and hierarchical clustering together with the Calinski-Harabasz (CH) index to quantify clustering performance (higher CH index indicates stronger clustering outcome). Results. The box plots flagged both unstable babies as outliers and none of the other babies. Successful clustering of the stable and unstable babies was achieved using the CV (CH = 72.8) and SD (CH = 63.3) but not with the mean. Conclusion. Taking the box plots and clustering results together, it seems plausible that variability might be more effective than mean level for detecting instability in oxygen saturation in preterm babies and that the combination of variability and level through the CV might be even better.

Effectiveness of pads and enclosures as safety interventions on consumer trampolines.

BACKGROUND: Trampolines continue to be a major source of childhood injury. OBJECTIVE: To examine available data on trampoline injuries in order to determine the effectiveness of padding and enclosures. DESIGN: Trampoline injuries from the NEISS database from 2002 to 2007 were reclassified into five cause-categories, to examine evidence for injury trends. SETTING: The ASTM trampoline standard recommendations for safety padding were upgraded in 1999 and enclosures were introduced in 1997. This is the first study to examine the impact of these changes. PATIENTS: The sampling frame comprises patients with NEISS product code 'consumer trampolines' (1233). A systematic sample of 360 patients each year is taken. INTERVENTIONS: The prominent interventions recommended by the ASTM are netting enclosures to prevent falling off and safety padding to cover frames and springs. MAIN OUTCOME MEASURES: Proportion of injuries within each cause-category and trend estimates. RESULTS: There was no evidence for a decline within the injury cause-categories that should be prevented by these interventions from 2002 to 2007. CONCLUSIONS: If these interventions were effective the associated injury causes would be in decline. Instead they remain close to half of all trampoline injuries with no significant change over the period of the study. Follow-up studies are proposed to determine the reasons. Given the number of injuries involved it is recommended that steps be taken to ensure these safety interventions or their equivalents are in place, work properly and remain effective for the life of consumer trampolines.