Patrick White

Background: Neural respiratory drive (NRD) measurement, reflecting the balance between respiratory muscle load and capacity, is quantified using surface parasternal electromyography (EMG _para ). EMG _para tracks recovery from severe exacerbations of chronic obstructive pulmonary disease (COPD). Among stable COPD participants, we hypothesised the existence of a relationship between NRD, breathlessness and airway obstruction. Study aims: (1) assessing the feasibility of measuring EMG _para in COPD participants with forced expiratory volume in 1 s (FEV ₁ ) ≥50% predicted in primary care; (2) investigating relationships between NRD measures, self-reported breathlessness, airflow obstruction severity and health-related quality of life (HRQoL). Methods: Participants with stable mild/moderate COPD, using inhaled corticosteroid (ICS) therapy, were recruited from 20 general practices. Participants were randomly allocated to continue using ICS (maintenance group) or to withdraw ICS (withdrawal group) over 6 weeks. EMG _para , spirometry, self-reported breathlessness (modified Borg dyspnoea scale), COPD Assessment Test and Chronic Respiratory Disease Questionnaire Self-Administered Standardised were measured at baseline, 3- and 6-month follow-up. Bland-Altman plots examined agreement between serial measurements. Results: Forty COPD participants were recruited: age 70±9.2 years; body mass index 26±5.3 kg/m ² ; FEV ₁ 1.74±0.54 L; and FEV ₁ % pred 69.6±14.0%. High-quality EMG _para data were obtained from 35 participants at baseline and 31 participants on three occasions. High intra-rater and inter-rater agreement for EMG _para (intraclass correlation coefficient >0.9) and moderate correlation between EMG _para and FEV ₁ % predicted (r=−0.42; p=0.01) were recorded. No correlation was observed between resting EMG _para and breathlessness or HRQoL measures across the three time points. Conclusions: EMG _para measurement is feasible in primary care. In this group of COPD patients, lung function was stable across the three time points and EMG _para was associated with the degree of airflow obstruction. In the resting stable state in mild/moderate disease, there was no association between EMG _para and participant-reported outcomes. Further work should investigate the utility of EMG _para in mild/moderate COPD participants during acute exacerbation and recovery.

Objective: Community health worker (CHW) interventions in control of HbA1c levels in diabetes have shown varied effects in randomised controlled trials. In the systematic review reported here, we aimed to evaluate the independent effectiveness of CHW interventions on the control of HbA1c levels in adults with type 2 diabetes. Design: Systematic review and meta-analysis. Participants: 1684 participants from 7 studies were included. Interventions: Randomised controlled trials of adults with type 2 diabetes receiving CHW interventions of at least 12 months’ duration compared with usual care were eligible. Databases searched were Ovid MEDLINE, the Cochrane Central Register, CINAHL and Web of Science from 2000 to March 2025. Quality was assessed using the Cochrane RoB2 tool. Primary outcome measure: Through meta-analysis, we calculated the mean weighted difference (MWD) of change in HbA1c level from baseline between groups using RevMan. Results: Seven of 86 retrieved studies were eligible. Six studies were suitable for meta-analysis and included 1280 participants. An inverse variance weighted meta-analysis showed a significant improvement in pooled HbA1c level with an MWD of 0.50% (0.28%, 0.71%) in the CHW group (p2=21%), and the overall level of certainty was high. Conclusions: CHW interventions in type 2 diabetes showed statistically significant and clinically important reductions in HbA1c levels in people from minority ethnic groups on low income.

Background: Recent evidence suggests that remote pulmonary rehabilitation (PR) meeting international criteria may be as effective as traditional in-person PR. During social distancing associated with COVID-19, in-person PR services were suspended in England. We assessed the use of remote PR services during COVID-19 social distancing. Methods: An online questionnaire survey to assess the use of remote PR during the COVID-19 pandemic and the subsequent availability and delivery of remote PR in England was conducted. The characteristics of PR services in England that provided remote PR, and the barriers and facilitators of delivery of remote online PR by videoconferencing were assessed. Results: Sixty-three services took part. Provision of remote PR rose from 17% to 95% for participating PR services during the pandemic. Remote PR was provided by telephone (65% of services), group videoconferencing (56%) and by individual patient videoconferencing (51%). Remote PR continued to be provided by 49 (76%) services following the relaxation of COVID-19-related restrictions on social contact. Barriers to the delivery of remote online PR using videoconferencing included patients’ lack of internet access through inability to use smart phones or computers and perceived preference of patients for in-person provision. Perceived facilitators of remote online PR using videoconferencing were ease of staff delivery and the belief that it would be beneficial to patients. Conclusion: Remote PR was widely used during the social distancing phase of the COVID-19 pandemic in England. Service users’ lack of access to the internet was an important barrier to videoconferencing, the form of remote online PR for which evidence of effectiveness is most compelling. The provision of digital equipment and internet training should be considered to enable more equitable access to remote online PR. Despite no guideline recommendations for its utility at present, remote pulmonary rehabilitation via telephone or online videoconferencing appears to be a safe and feasible alternative when in-person pulmonary rehabilitation is unavailable.

Objectives Many patients presenting with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in primary care do not benefit from antibiotics. Excessive use wastes resources, promotes antimicrobial resistance and can harm patients. Design We conducted a within-trial economic evaluation, using a UK National Health Service perspective, as part of the multicentre, parallel-arm, open, individually randomised, controlled PACE trial. Setting Participating general practices in primary care. Participants PACE included 324 and 325 consenting participants presenting with AECOPD in the usual-care and CRP-guided groups, respectively. Intervention We assessed the cost-effectiveness (CE) of a C-reactive protein point-of-care-test (CRP-POCT) in addition to usual clinical assessment to guide antibiotic prescribing for AECOPD in primary care. Primary and secondary outcome measures A cost-effectiveness analysis (CEA) of incremental cost per 1% antibiotic consumption reduction at 4 weeks and a cost-utility analysis (CUA) at 6 months were performed, based on a modified intention-to-treat population. Sensitivity analyses assessed the impact of uncertainty on the results. CE acceptability curves represent the probability of CRP-POCT being cost-effective at different willingness-to-pay (WTP) thresholds. Results Both groups had similar clinical outcomes, but a 20% absolute reduction in antibiotic consumption was observed in the CRP-guided group. CRP-POCT costs of £11.31 per test were largely offset by savings in healthcare resource use related to COPD. The mean incremental CE ratios of CRP-POCT were £120 per 1% absolute reduction in antibiotic consumption at 4 weeks and £1054 per quality-adjusted life-year (QALY) gained at 6 months. Sensitivity analysis showed that the CEA results were most affected by changes in healthcare costs, while CUA was sensitive due to marginal differences in costs and outcomes. There is a 73% probability of CRP-POCT being cost-effective at WTP ≤£20 000 per QALY gained. Conclusion CRP-POCT is a cost-effective intervention for safely reducing antibiotic consumption in patients with AECOPD. Trial registration number ISRCTN24346473

Background: Inhaled corticosteroid (ICS) therapy has been demonstrated to reduce the risk of COPD exacerbations. It should only be prescribed to COPD patients who are not adequately controlled by dual long-acting bronchodilator therapy and who have ≥ 2 exacerbations per year and a blood eosinophil count ≥ 300cells/μL. ICS therapy is widely prescribed outside guidelines to COPD patients, making ICS withdrawal an important consideration. This systematic review aims to provide an up-to-date analysis of the effect of ICS withdrawal on exacerbation frequency, change in lung function (FEV₁) and to determine the proportion of COPD patients who resume ICS therapy following withdrawal. Methods: Randomised controlled trials (RCTs) and observational studies which compared ICS withdrawal with ICS continuation treatment were included. Cochrane Central, Web of Science, CINHAL, Embase and OVID Medline were searched. Risk of bias was assessed using the Cochrane RoB2 tool and the Newcastle-Ottawa Scale. Quality assessment of RCTs was conducted using GRADE. Meta-analysis of post-hoc analyses of RCTs of ICS withdrawal, stratified by blood eosinophil count (BEC), was undertaken. Results: Ten RCTs (6642 patients randomised) and 6 observational studies (160,029 patients) were included in the results. When ICS was withdrawn and long-acting bronchodilator therapy was maintained, there was no consistent difference in exacerbation frequency or lung function change between the ICS withdrawal and continuation trial arms. The evidence for these effects was of moderate quality. There was insufficient evidence to draw a firm conclusion on the proportion of patients who resumed ICS therapy following withdrawal (estimated range 12– 93% of the participants). Discussion: Withdrawal of ICS therapy from patients with COPD is safe and feasible but should be accompanied by maintenance of bronchodilation therapy for optimal outcomes.

Background: Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benefits of PR are limited by poor uptake and completion. This trial will determine whether using trained volunteer lay health workers, called “PR buddies,” improves uptake and completion of PR and is cost-effective. This trial protocol outlines the methods for evaluating effectiveness, cost-effectiveness, and acceptability. Methods: The IMPROVE trial is a pragmatic, open, cluster randomised controlled trial planned in 38 PR services across England and Wales. PR services will be randomised to either intervention arm—offering support from PR buddies to patients with chronic obstructive pulmonary disease—or to usual care as the control arm. PR staff in trial sites randomised to the intervention arm will receive training in recruiting and training PR buddies. They will deliver training to volunteers, recruited from among people who have recently completed PR in their service. The 3-day PR-buddy training programme covers communication skills, confidentiality, boundaries of the PR-buddy role and behaviour change techniques to help patients overcome obstacles to attending PR. An internal pilot will test the implementation of the trial in eight sites (four intervention sites and four in control arm). The primary outcome of the trial is the uptake and completion of PR. A process evaluation will investigate the acceptability of the intervention to patients, PR staff and the volunteer PR buddies, and intervention fidelity. We will also conduct a cost-effectiveness analysis. Discussion: Improving outcomes for chronic obstructive pulmonary disease and access to PR are priorities for the UK National Health Service (NHS) in its long-term plan. The trial hypothesis is that volunteer PR buddies, who are recruited and trained by local PR teams, are an effective and cost-effective way to improve the uptake and completion rates of PR. The trial is pragmatic, since it will test whether the intervention can be incorporated into NHS PR services. Information obtained in this trial may be used to influence policy on the use of PR buddies in PR and other similar services in the NHS. Trial registration: ISRCTN12658458. Registered on 23/01/2023.

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive–behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive–behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant’s own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive–behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale – anxiety and Hospital Anxiety and Depression Scale – depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale – anxiety mean difference –0.60, 95% confidence interval –1.40 to 0.21; Hospital Anxiety and Depression Scale – depression mean difference –0.66, 95% confidence interval –1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval –£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants’ lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive–behavioural approach intervention, but high-intensity cognitive–behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive–behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.