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Background Peripheral arterial disease is common and associated with increased cardiovascular morbidity and mortality. While patients with peripheral arterial disease are known to benefit from supervised exercise therapy, it is not always available. Neuromuscular electrical stimulation devices may offer a similar benefit. A randomised controlled trial was required to ascertain whether such devices can benefit patients who receive supervised exercise therapy and those who do not. Objective(s) The primary objective was to assess the mean difference in absolute walking distance at 3 months in intermittent claudication patients receiving either a neuromuscular electrical stimulation device and local standard care (intervention), or local standard care alone (control). Design A pragmatic, multicentre, randomised controlled trial stratified by centre. Setting Secondary-care National Health Service hospitals in the United Kingdom. Participants Patients aged ≥18 years, with a diagnosis of intermittent claudication according to the Edinburgh Claudication Questionnaire and ankle–brachial pressure index (or stress test), without contraindications to neuromuscular electrical stimulation were deemed eligible to partake. Interventions Participants were randomised 1 : 1 to either local standard care or local standard care and neuromuscular electrical stimulation. Due to the nature of the intervention, it was unfeasible to blind the research nurse or participant to the study allocation. Main outcome measures The primary outcome measure was absolute walking distance measured by treadmill testing at 3 months. Secondary outcomes included change in initial claudication distance, quality of life, compliance with interventions and haemodynamic assessments. Results Two hundred patients underwent randomisation, with 160 patients having analysable primary outcome data for the intention-to-treat analysis intervention (n = 80); control (n = 80). As the data were right-censored, a Tobit regression model was used to analyse the primary outcome, utilising the square root of the absolute walking distance to accommodate the skewed data. However, as this made the data difficult to interpret, a Tobit regression model using raw absolute walking distance data was used as well. Neuromuscular electrical stimulation improved the difference in absolute walking distance at 3 months but this was not statistically significant (square root of absolute walking distance: 0.835 units, 95% confidence interval −0.67 to 2.34 units; p = 0.28/absolute walking distance raw data: 27.18 m, 95% confidence interval −26.92 to 81.28 m; p = 0.323). Supervised exercise therapy participants showed a markedly improved absolute walking distance compared with patients receiving best medical therapy only at 3 months (square root of absolute walking distance: 3.295 units 95% confidence interval 1.77 to 4.82; p < 0.001/absolute walking distance raw data: 121.71 m, 95% confidence interval 67.32 to 176.10; p ≤ 0.001). Neuromuscular electrical stimulation significantly improved absolute walking distance at 3 months for mild claudicants (square root of absolute walking distance: 2.877 units, 95% confidence interval 0.51 to 5.25; p = 0.019/absolute walking distance raw data: 120.55 m, 95% confidence interval 16.03 to 225.06; p = 0.03) compared to the control arm. This was an unplanned (post hoc) analysis. There were no clear differences in mechanistic measurements between the two treatment groups over the follow-up period. Serious adverse events were evenly reported between the two groups; all being classified as either not related or unlikely to be related to the study device. Limitations Absolute walking distance was used as the primary outcome measure; there was a large range of baseline distances in both groups with right-skewed distribution. We did not stratify by baseline absolute walking distance for the primary outcome analysis. Additionally, only 160 patients had analysable primary outcome data due to missing treadmill data. Conclusions Supervised exercise therapy is an effective treatment for intermittent claudication. Neuromuscular electrical stimulation appears to be beneficial as an adjunct to supervised exercise therapy and on its own in mild claudicants. Future work Further studies are needed to confirm the effectiveness of neuromuscular electrical stimulation in combination with supervised exercise therapy, and in mild to moderate claudicants in a larger sample size. Study registration This trial is registered as ISRCTN18242823. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership (project number 15/180/68). This will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No. 2. See the NIHR Journals Library website for further project information. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) (with others, e.g. NIHR Imperial CRF, Imperial College ECMC, NIHR Imperial PSTRC, NIHR London MIC, etc.). Plain language summary Why did we conduct this research? Patients with intermittent claudication present with pain in the lower limbs on exercising, relieved by rest. This negatively impacts on exercise tolerance and quality of life. Initially, such patients should be offered best medical therapy, including exercise advice, and a supervised exercise therapy programme. Supervised exercise therapy involves leg and feet exercises supervised by health-care professionals and, despite evidence favouring supervised versus unsupervised exercise, are underutilised in the United Kingdom. Therefore, there remains a significant difference between recommended standard care (best medical therapy and supervised exercise therapy) and ‘real-world’ standard care (best medical therapy only). Neuromuscular electrical stimulation devices have emerged as safe, portable and readily accessible, with some evidence suggesting they can improve outcomes, including pain-free walking distance and quality of life. This study investigated whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy). What did we do? Two hundred patients diagnosed with intermittent claudication at 11 hospitals in England took part. A computer program randomly assigned half the patients to local standard care only, while the other half were given a neuromuscular electrical stimulation device which delivers electrical stimulation to leg and feet muscles through foot-pads, plus local standard care. What did we find? There was no clear difference in maximal walking distances between those who received a device and those who didn’t. However, neuromuscular electrical stimulation improved walking distances in patients who attended a supervised exercise therapy programme (although not significant), and clearly improved walking distances in those patients with a good baseline upper walking limit. Supervised exercise therapy significantly improved walking distances. What could be done next? Future research studies should further evaluate the effectiveness of neuromuscular electrical stimulation in combination with supervised exercise therapy, and in patients who have a good baseline walking distance in a larger sample of patients with intermittent claudication. Scientific summary Background Peripheral arterial disease (PAD) is a common condition that is predominantly caused by atherosclerosis, resulting in a reduced blood flow to the affected limb. It presents a significant global health burden, affecting over 200 million people worldwide. These individuals are at higher risk of other cardiovascular events and PAD itself has its own associated sequelae – for example, ulcer development. Intermittent claudication (IC) is the commonest symptom of PAD, patients experiencing leg pain while walking which is relieved by rest. This has a significant impact on exercise tolerance and quality of life. According to National Institute for Health and Care Excellence guidelines, all patients suffering from IC should receive both first-line treatment of best medical therapy (BMT) (including exercise advice) and supervised exercise therapy (SET). SET is known to significantly improve absolute walking distance (AWD) in IC patients but despite these guidelines, recommended care for the first-line management of claudication is significantly below standard, largely due to lack of National Health Service capability. Without a demonstrable benefit of non-invasive strategies for the management of IC, there is an increased likelihood of invasive treatment options. Neuromuscular electrical stimulation (NMES) is an emerging technology and such devices are readily accessible and can be used in the patient’s own home. Although some evidence of the efficacy of NMES in the management of patients with IC exists, in improving both functional and quality-of-life measures, further high-quality research is required. The NESIC (A Multicenter Randomised Controlled Study: Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients with Intermittent Claudication (NESIC) compared to best available treatment?) study provides an evidence base for the efficacy of the REVITIVE IXTM (Actegy Health Ltd, Bracknell, UK) device in the non-invasive management of claudicants and assesses the cost-effectiveness of the device compared to SET. Objectives (list of research questions) 1.Primary objective: To assess the clinical efficacy of a NMES device as an adjunct to the local standard care available at the study randomisation sites to improve AWD in patients with IC. 2.Secondary objectives: a.To understand the underlying mechanisms for change in clinical and subjective outcomes in the form of lower-limb gross (duplex ultrasound) and superficial haemodynamic assessment (laser doppler flowmetry) b.To determine compliance with NMES device and SET programme c.To compare quality of life between those receiving local standard care alone and those receiving both local standard care and NMES d.To assess the actual cost-effectiveness of the NMES device compared to SET. Methods Design A multicentre, pragmatic, randomised clinical trial to compare the mean difference in AWD in patients with IC who are given NMES in addition to local standard care and those receiving local standard care only. Setting Eleven secondary-care NHS hospitals across England; a combination of centres with and without established provision of SET. Participants Between March 2018 and 17 March 2020, 200 participants were randomised into the NESIC trial. Follow-up was completed on 31 March 2021. Written informed consent was obtained from all participants, who then underwent eligibility assessments. Participants, as defined by the inclusion and exclusion criteria, were randomised 1 : 1 to either local standard care alone (standard care), or NMES and local standard care (intervention). Inclusion criteria •positive Edinburgh Claudication Questionnaire •ankle–brachial pressure index 30 mmHg, 40 seconds post 1 minute treadmill at 10% gradient, 4 km/hour) •able to give informed consent to participate in the trial after reading the patient information documentation •age ≥18 years. Exclusion criteria •severe IC requiring invasive intervention as determined by the treating clinician •critical limb ischaemia as defined by the European Consensus Document •comorbid disease prohibiting walking on a treadmill or taking part in SET •able to walk for longer than 15 minutes on the study treadmill assessment •have attended SET classes in the previous 6 months •popliteal entrapment syndrome •commenced vascular-symptom-specific medication in previous 6 months – for example, naftidrofuryl oxalate, cilostazol •pregnancy •any implanted electronic, cardiac or defibrillator device •acute deep vein thrombosis •broken or bleeding skin, including leg ulceration •peripheral neuropathy •recent lower-limb injury or lower back pain •already using a NMES device. Randomisation Randomisation (1 : 1) was web-based and hosted by Oracle Health Sciences InForm™ (Oracle®; Health Sciences, Austin, TX, USA) electronic data capture on an Oracle platform. Randomisation used random block size and was stratified by centres. Interventions The NMES device (REVITIVE IX) can be used in the patient’s own home. It delivers a 30-minute pre-programmed session of electrical stimulation to the lower-limb muscles through foot pads while the patient is in a seated position. The user controls the intensity of the impulses, and therapeutic benefit is deemed to occur when impulses are sufficient to cause contraction of the calf muscles, increasing venous return to the heart. The IsoRocker feature allows the device to tilt back and forth as the muscles contract and relax. The device is to be used for at least one 30-minute session daily (up to a maximum of six sessions) for 3 months (treatment period). Diabetic patients are to use the device for a minimum of two 30-minute sessions daily for the duration of the treatment period to better reflect the evidence supporting the diabetic patient group and improvement of their symptoms. A SET programme is usually led by a physiotherapist or allied health-care provider supervising exercise, usually within the physiotherapy gymnasium with equipment including a treadmill, steps and walking cones. SET classes usually involve a circuit of lower-limb exercises, for a minimum of 30 minutes per week, and usually over a 3-month duration. Outcomes and follow-up The primary outcome was AWD at 3 months, measured by treadmill testing. Secondary outcomes included quality of life over 12 months as measured by generic health-related quality of life tools, European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L®) (EuroQol Group, Rotterdam, The Netherlands), Short-Form Health Survey-36 (SF-36®) (RAND Health Care, Santa Monica, CA, USA) and the intermittent claudication questionnaire; compliance with NMES and SET as measured against self-report participant diaries and device data loggers; change in initial claudication distance measured by treadmill testing; and haemodynamic assessments measured by duplex ultrasound and laser doppler flowmetry. Participants in both groups were followed up for 12 months post randomisation. In-person visits were performed at screening/baseline (randomisation), 3 months, 6 months and 12 months. The treadmill assessment (Gardner-Skinner protocol) and laser doppler flowmetry of the foot were completed at each visit and the duplex ultrasound was performed by a vascular scientist at baseline and 3 months only. Self-report health resource-use participant diaries were completed throughout the 12-month duration of the study. Additionally, the self-report exercise diaries were completed by all participants for 3 months or for the duration of the SET programme, and the device compliance diaries were completed by participants randomised to NMES for the duration of the treatment period. A device experience questionnaire was completed at 3 months for participants in the NMES arm of the trial. The quality-of-life questionnaires were administered at baseline and each follow-up either in person, via the telephone or via post. Participant follow-up is summarised in Appendix 1. Due to the COVID-19 crisis, a substantial amendment was submitted to Ethics in April 2020 to allow all follow-up visits to take place remotely (i.e. over the telephone completely or in combination with postal questionnaires) in the event that the participant was unable to attend in clinic or the site was unable to accommodate the on-site visit. Missed (physical) assessments as a result of a remote visit were rescheduled at a later date as a separate on-site visit, where possible. If an on-site visit was rescheduled at a later date, all quality-of-life questionnaires that were completed remotely were repeated at the on-site visit. Results (research findings) Two hundred participants underwent randomisation and 160 were included in the intention-to-treat primary analysis [intervention (n = 80); control (n = 80)]. NMES improved AWD in patients with IC following the 3-month treatment period but this was not statistically significant [square root of AWD: 0.835 units, 95% confidence interval (CI) −0.67 to 2.34; p = 0.276/AWD raw data: 27.18 m, 95% CI −26.92 to 81.28; p = 0.323]. Participants who had access to a SET programme showed a clear improvement in AWD compared with patients who received BMT only at 3 months (square root of AWD: 3.295 units, 95% CI 1.77 to 4.82; p < 0.001/AWD raw data: 121.1 m, 95% CI 67.32 to 176.10; p < 0.001). Improvements in the AWD at 3 months were seen when NMES was used in combination with SET, but this was not significant (square root of AWD: 1.724 units, 95% CI −0.56 to 4.01; p = 0.137/AWD raw data: 64.26 units, 95% CI −20.03 to 148.54; p = 0.13). NMES significantly improved AWD at 3 months for patients who could walk for more than 340 m at baseline (square root of AWD: 2.877 units, 95% CI 0.51 to 5.25; p = 0.019/AWD raw data: 120.55 m, 95% CI 16.03 to 225.06; p = 0.03) compared to the control arm. Mechanistic findings of the laser doppler flowmetry found no clear differences in blood flux between the two treatment groups over the 12-month follow-up period, nor any significant differences in volume flow or time average mean velocity (duplex ultrasound) groups at 3 months. Serious adverse events (n = 29) were reported in 24 participants, with all events being classified as either not related or unlikely to be related to the study device. The number of SAEs in the treatment arm was 13 and 16 in the control arm. Most of the events required hospitalisation; there were four deaths. Conclusions The results of the NESIC trial indicate that SET is the most effective treatment option for patients with IC. Although not significant, NMES improves walking distances when used in combination with a SET programme, and significantly improves AWD in mild claudicants. Implications for health care Findings from this trial suggest that all IC patients should have access to a SET programme and changes to such programmes may need to be made to encourage and/or retain participants. NMES may be an effective adjunct to SET and in patients with a good baseline walking distance. Recommendations for research (numbered in priority order) 1.Randomised controlled trial of NMES as an adjunct to SET in IC patients stratified by baseline AWD, as the NESIC study showed promise of non-invasive effectiveness in mild and/or moderate claudicants at improving walking distances, but larger numbers are required to validate this finding. 2.Research to examine the poor patient motivation and adherence to SET, as SET is clearly an effective treatment option for claudicants as seen in this study and many other studies but uptake/compliance remains an issue. 3.Research to evaluate the long-term effectiveness of SET programmes on maximal walking distance (MWD) and secondary outcomes such as quality of life and long-term engagement in physical activity. The NESIC study showed the effectiveness of SET at 12 months at improving AWD but longer-term follow-up is required to evaluate whether this is sustained years later. Previous studies have shown mixed results on the impact of SET on other outcomes, such as quality of life, and therefore further research is required. Study registration This trial is registered as ISRCTN18242823. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership (project number 15/180/68). This will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No. 2. See the NIHR Journals Library website for further project information. Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) (with others, e.g. NIHR Imperial CRF, Imperial College ECMC, NIHR Imperial PSTRC, NIHR London MIC, etc.).

Achieving gender equity in radiation oncology is an important goal, as a smaller proportion of women enter radiation oncology residency compared with those graduating from medical school. As invited speaking opportunities at academic medical conferences are vital for promotion/tenure, we investigated the prevalence of all-men panels ("manels") at American Society for Radiation Oncology (ASTRO) and Canadian Society of Radiation Oncology (CARO) annual meetings. Using ASTRO and CARO online meeting programs, 2018 to 2021 faculty information was obtained, including gender, panel role (chair vs nonchair), type of session, and topic. Primary outcomes included percentage of manels and proportion of female panelists over time. Representation of women among chairs was also evaluated. Over the 4-year study period across both conferences, a total of 765 panel sessions were held with 2973 faculty members, of whom 1287 (43.3%) were women. Of these sessions, 127 of 765 (16.6%) were manels. ASTRO meetings had 1169 of 2742 (42.6%) female faculty members and held 107 of 680 (15.7%) manels, whereas CARO meetings had 118 of 231 (51.1%) female faculty and held 20 of 85 manels (23.5%). From 2018 to 2021, the proportion of manels decreased at ASTRO and CARO meetings from 25.6% to 8.2% (P <.001) and from 29.6% to 15.0% (P =.130), respectively. The role of chair was majority male in every year from 2018 to 2021 at ASTRO meetings (58.6% overall), but more balanced at CARO meetings (48.0% overall). Among session types, the highest proportion of manels was observed for scientific sessions (19.1%, P =.011) at ASTRO meetings and leadership sessions (29.4%, P =.533) at CARO meetings. The lowest proportion of female panelists was on genitourinary cancer topics at ASTRO meetings (31.9%, P =.018) and physics topics at CARO meetings (40.4%, P =.085). During the study period, the proportion of female panelists increased with a corresponding decrease in manels. ASTRO and CARO should strive for further involvement of women and the elimination of manels whenever possible. [ABSTRACT FROM AUTHOR]

Objectives A life-course perspective emphasizes healthy behaviors before, during, and after pregnancy to support a multi-generational risk reduction in obesity for mothers and infants. Optimal timing, content, and dose of such interventions is not well defined. Methods We conducted a nested cohort within a randomized trial to evaluate whether a healthy lifestyle intervention around pregnancy led to a 'spill-over effect,' including a healthier rate (kg/week) of maternal gestational weight gain, and infant growth during the first year. Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019. The intervention focused on healthy maternal diet and physical activity but not pregnancy weight or infant feeding. Outcome data were abstracted from electronic medical records. Results Of the 165 women who became pregnant, 114 enrolled in the nested cohort. The average pre-pregnancy BMI was 29.6 (SD 5.1) kg/m.sup.2. Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005). Conclusions for Practice A behavioral intervention that focused on overall maternal health delivered in the time around pregnancy did not result in a 'spill-over effect' on healthy gestational weight gain or healthy infant growth during the first year of life. Trial Registration This study is registered at http://www.clinicaltrials.gov http://www.clinicaltrials.gov NCT01316653., Author(s): William J. Heerman [sup.1] , Lauren R. Samuels [sup.2] , Lauren Barr [sup.3] , Laura E. Burgess [sup.1] , Katherine E. Hartmann [sup.4] , Shari L. Barkin [sup.1] Author [...]

This article provides an overview of research on social contagion in the context of education. We highlight the importance of students' social interactions in school, considering contagion between peers and contagion from teachers to students, using a motivation perspective. The framework of contagion is introduced broadly, followed by a focused review on social contagion in school environments, both peer and teacher related. Then we introduce methodology for mapping behavior change to networks that are a direct representation of school cohorts. We argue that these different lines of research can be coherently interpreted from a motivation perspective, suggesting the critical role of motivation in social contagion, in the context of education. We highlight the limited amount of research on positive contagion effects and we call for further investigation into ways in which to increase the contagion of positive, academic behaviors. Finally, the neuroscience behind social contagion, both for the mechanisms and the interactions, is discussed.

Methods: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. Results: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. Conclusion: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC. This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823. [ABSTRACT FROM AUTHOR]