Introduction Although lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making. Methods and analysis We describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test). Ethics and dissemination Ethical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter. Trial registration number ISRCTN19684749 ; Pre-results.

NICE’s evidence standards framework (ESF) for digital health technologies (DHTs) describes expected health technology assessment evidence levels for the commissioning of these technologies in the NHS. NICE's medical technologies evaluation programme (MTEP) develops guidance on medical devices and diagnostics which are claimed to be cost saving for the NHS. Medical technologies guidance has been published on 5 DHTs. Here we present a summary of the evidence for each technology and compare it with the evidence levels suggested in the ESF. Guidance development for the DHTs was based on the existing NICE MTEP process and methods which aim to evaluate the clinical effectiveness and economic impact of the technology. Consideration of the ESF evidence levels is not part of the existing process. Two reviewers assessed the evidence for each technology published in the NICE committee papers compared with the relevant ESF levels. The 5 DHT’s with NICE medical technologies guidance include 3 diagnostics, 1 therapeutic and 1 self-management tool. The clinical evidence available shows that all 5 DHTs reviewed had clinical studies to demonstrate their effectiveness. Most of the technologies had multiple studies with different designs, settings and outcomes. In some cases the studies did not include the appropriate population or comparator or were not of high quality. In general the economic evidence was weaker and there was uncertainty about the claimed cost savings for some technologies. This was usually related to a lack of knowledge of the resource consequences associated with including the technology in the care pathway. In general there is good alignment between the suggested evidence levels in the ESF and the evidence available for technologies with NICE guidance. However we noted the guidance development process does not include assessment of a budget impact model as suggested by the ESF.

Introduction and objectives Impaired skeletal muscle function is an important systemic manifestation of COPD which can be improved by exercise training. Non-volitional training using neuromuscular electrical stimulation (NMES) may be an effective training technique in situations where voluntary exercise may be difficult or impractical (e.g. peri-exacerbation or severe ventilatory limitation). Exercise is known to result in both intramuscular and systemic inflammation. However, the cellular response to NMES, which directly depolarises the motor units, is unclear. We investigated the impact of acute and repeated bouts of unilateral NMES in COPD patients. Methods 16 patients underwent 6 weeks of unilateral NMES 5 times a week for 30 min at 50 Hz at Glenfield Hospital, Leicester. Mean (SD) age was 65 (9) years, FEV1: 50 (22)% predicted, BMI 26.5 (5.2) Kg/m2). Isometric quadriceps strength, regional muscle mass (DEXA) and quadriceps thickness (ultrasound) were recorded at baseline and at the end of the intervention. Vastus lateralis muscle biopsies were obtained from both the trained and untrained limbs at baseline, 24 h after the first bout of NMES and at 6 weeks. Venous blood was taken at the same time. Biopsies were analysed for neutrophil (neutrophil elastase) and macrophage (CD163) density using immunohistochemistry. ELISA measurements of inflammatory cytokines (IL-6 and TNFα) were performed on blood samples. Results Quadriceps strength increased by 7.6% (p = 0.024), thigh mass by 2.8% (p = 0.185), and quadriceps thickness by 11% (p = 0.002). Muscle biopsies for 11 patients were analysed. Neutrophil density 24 h after a single bout of unilateral NMES significantly increased in both the trained and untrained limb, with larger increase in the stimulated muscle (Table 1). Neutrophil density returned to baseline in the trained limb following training. No changes were seen in muscle macrophage density, serum IL-6 or serum TNFα. Conclusion A single bout of unilateral NMES provokes an intramuscular neutrophilic inflammatory response in both the trained and untrained limb, which are not mediated by changes in circulating IL-6 or TNFα. Neutrophil infiltration returned to baseline in the stimulated leg following training.

Introduction Deconditioning is a key cause of exercise intolerance in COPD patients. Exercise training provides an effective method of improving aerobic exercise performance in this group. There is poor understanding on the trajectory of changes made in exercise performance between COPD and Healthy controls (HC), during aerobic training and more importantly limited data exists on the rates of detraining between the groups. Methods This study measures sub-maximal and maximal performance in response to an aerobic training programme and to a period of detraining. COPD and HC undertook 8 weeks of supervised cycling exercise training three times a week. There consequently followed a 4 week period of detraining, and resumption of pre cycling habitual activity (not engaging in regular exercise). A symptom limited incremental cycle (ramp protocol) and constant work rate (sub-maximal/endurance) cardiopulmonary exercise tests (CPET) were performed at baseline, after 4 and 8 weeks of training and after detraining. Cycling training intensity and CPET endurance work were equivalent to 65% of the Work (in Watts (W)) at VO2 Peak during the baseline CPET ramp test. Training intensity was re-set if there was any improvement during the 4-week CPET ramp test. Results 10 COPD patients (MRC 3, 2 males, age 74 years, FEV1 63.5% predicted) and 7 HC (MRC 1, 4 males, age 71 years, FEV1 111% predicted) completed the study. COPD group had lower starting training workloads (59.5 vs 121 Watts, p<0.05) compared to HC. HC showed a significant increase in Peak VO2 uptake in the ramp but COPD patients only showed an increasing trend. There were however increases in the time achieved during sub-maximal testing in both groups during the 8 week training period. However during detraining, there was relative preservation in the HC but a significant reduction in endurance time in the COPD group. (All values median, unless stated) Conclusion/discussion Exercising training at moderate intensities showed no changes in maximal performance in COPD groups, compared to HC. However gains in sub-maximal performance were seen in both groups. Training induced gains in sub-maximal performance may be better preserved in HC during detraining, when compared to the COPD groups.