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Spencer J Keene,1–3 Rachel E Jordan,1 Frits ME Franssen,3,4 Frank de Vries,2,5 James Martin,1 Alice Sitch,1,6 Alice Margaret Turner,1 Andrew P Dickens,1 David Fitzmaurice,7 Peymane Adab1 1Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; 2Department of Clinical Pharmacy & Toxicology, Maastricht University Medical Center+, Maastricht, the Netherlands; 3Ciro, Horn, the Netherlands; 4Department of Respiratory Medicine, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, The Netherlands; 5Utrecht Institute for Pharmaceutical Sciences Utrecht University, Utrecht, The Netherlands; 6NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK; 7Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKCorrespondence: Rachel E JordanInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UKTel +44 0121 414 6775Email r.e.jordan@bham.ac.ukBackground: Reviews suggest that the ADO score is the most discriminatory prognostic score for predicting mortality among chronic obstructive pulmonary disease (COPD) patients, but a full evaluation and external validation within primary care settings is critical before implementation.Objectives: To validate the ADO score in prevalent and screen-detected primary care COPD cases at 3 years and at shorter time periods.Patients and methods: One thousand eight hundred and ninety-two COPD cases were recruited between 2012 and 2014 from 71 United Kingdom general practices as part of the Birmingham COPD Cohort study. Cases were either on the practice COPD register or screen-detected. We validated the ADO score for predicting 3-year mortality with 1-year and 2-year mortality as secondary endpoints using discrimination (area-under-the-curve (AUC)) and calibration plots.Results: One hundred and fifty-four deaths occurred within 3 years. The ADO score was discriminatory for predicting 3-year mortality (AUC= 0.74; 95% CI: 0.69–0.79). Similar performance was found for 1- (AUC= 0.73; 0.66–0.80) and 2-year mortality (0.72; 0.67–0.76). The ADO score showed reasonable calibration for predicting 3-year mortality (calibration slope 0.95; 0.70–1.19) but over-predicted in cases with higher predicted risks of mortality at 1 (0.79; 0.45–1.13) and 2-year (0.79; 0.57–1.01) mortality.Discussion: The ADO score showed promising discrimination in predicting 3-year mortality in a primary care population including screen-detected cases. It may need to be recalibrated if it is used to provide risk predictions for 1- or 2-year mortality since, in these time-periods, over-prediction was evident, especially in cases with higher predicted mortality risks.Keywords: pulmonary disease, chronic obstructive, mortality, prognosis, validation studies

Martin R Miller,1 Shamil Haroon,1 Rachel E Jordan,1 Alice J Sitch,1 Andrew P Dickens,1 Alexandra Enocson,1 David A Fitzmaurice,2 Peymané Adab1 1Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; 2Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK Background: Consensus on the definition of airflow obstruction to diagnose COPD remains unresolved.Methods: We undertook systematic case finding for COPD in primary care using the fixed ratio (FR) criterion (forced expiratory volume in 1 s/forced vital capacity [FEV1/FVC]

Sarah B Brien,1 Beth Stuart,1 Andrew P Dickens,2 Tony Kendrick,1 Rachel E Jordan,2 Paymane Adab,2 Mike Thomas1 1Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, Hampshire, 2Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, Warwickshire, UK Purpose: Quality-of-life (QoL) scores in chronic obstructive pulmonary disease (COPD) have a weak relationship with physiologic impairment. We investigated factors associated with poor QoL, focusing on psychological measures potentially amenable to intervention.Patients and methods: We utilized a pre-existing Birmingham (UK) COPD cohort to assess factors associated with QoL impairment (COPD Assessment Test [CAT] scores). Univariate and multivariate regression models were constructed from three categories of variables: demographic, lung function/COPD-related symptoms, and psychosocial/behavioral factors.Results: Analyses were based on self-report questionnaire data from 735 participants. The multivariate model of variables independently associated with CAT included depression, dysfunctional breathing symptoms (Nijmegen score), and illness perception, in addition to COPD symptoms (wheeze, cough), exercise capacity, breathlessness, exacerbations, and deprivation; this model explained 72% of CAT score variation. In a dominance analysis assessing the relative contribution of variables, similar contributions were made by breathlessness (20.2%), illness perception (19.8%), dysfunctional breathing symptoms (17.5%), and depression (12.5%) with other variables contributing

Maria-Christina Kosteli,1 Nicola R Heneghan,1 Carolyn Roskell,1 Sarah E Williams,1 Peymane Adab,2 Andrew P Dickens,2 Alexandra Enocson,2 David A Fitzmaurice,2 Kate Jolly,2 Rachel Jordan,2 Sheila Greenfield,2 Jennifer Cumming1 1School of Sport, Exercise and Rehabilitation Sciences, 2Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, UK Background: Given that physical activity (PA) has a positive impact on COPD symptoms and prognosis, this study examined the factors that both encourage and limit participation in PA for individuals with COPD in a primary care setting from the perspective of social cognitive theory.Methods: A purposive sample of 26 individuals with a range of COPD severity (age range: 50–89 years; males =15) were recruited from primary care to participate in one of four focus groups. Thematic analysis was undertaken to identify key concepts related to their self-efficacy beliefs.Results: Several barriers and enablers closely related to self-efficacy beliefs and symptom severity were identified. The main barriers were health related (fatigue, mobility problems, breathing issues caused by the weather), psychological (embarrassment, fear, frustration/disappointment), attitudinal (feeling in control of their condition, PA perception, older age perception), and motivational. The main enabling factors were related to motivation (autonomous or controlled), attitudes, self-regulation, and performance accomplishments.Clinical implications: When designing interventions for individuals with COPD, it is important to understand the patient-specific social cognitive influences on PA participation. This information can then inform individually tailored management planning. Keywords: COPD, social cognitive theory, self-efficacy, barriers, enablers, primary care

Physical activity (PA) improves dyspnoea, psychological wellbeing and quality of life (QoL) for people with COPD reducing their risk of exacerbation. However, engagement in PA is low especially amongst those with anxiety and depression, and PA programmes are limited in countries with limited resources such as Brazil. We explored perceptions of 21 people with COPD about the impact of their disease on taking part in community-based PA programmes in Sao Paulo, Brazil through semi-structured telephone interviews from October 2020 to April 2021. Discussions were audio-recorded, transcribed, and analysed using the Framework method. Five themes were identified: Knowledge about COPD and its management; Self-perception of life with COPD; Knowledge and experiences of depression and anxiety; Opinions on PA and repercussions of COVID-19. PA was considered to be important in bringing physical and mental health benefits but there were barriers in accessibility of formal PR programmes and therefore local community PA programmes were considered to be important. People with mental health conditions tended to view PA more negatively. COVID-19 had reduced PA opportunities, access to COPD treatment and social interaction, and was associated with more exacerbations and emotional suffering. In general, this study showed an urgent need to improve knowledge about COPD and its risk factors and management among both patients, the public and primary healthcare professionals. We provide important content for the formulation of public policies for the implementation of specific activity programmes for people with COPD in community spaces using local resources and intersectoral partnerships., (© 2024. The Author(s).)

Background: Within primary care there exists a cohort of patients misdiagnosed with Chronic Obstructive Pulmonary Disease (COPD). Misdiagnosis can have a detrimental impact on healthcare finances and patient health and so understanding the factors leading to misdiagnosis is crucial in order to reduce misdiagnosis in the future. The objective of this study is to understand and explore the perceived causes of COPD misdiagnosis in primary care., Methods: A sequential mixed methods study, quantifying prevalence and features of patients misdiagnosed with COPD in primary care followed by a qualitative analysis to explore perceived causes of misdiagnosis. Quantitative data was collected for 206 patients identified as misdiagnosed with COPD within the INTEGR COPD study (NCT03482700). Qualitative data collected from 21 healthcare professionals involved in providing COPD care and 8 misdiagnosed patients who were recruited using a maximum variation purposive sampling., Results: Misinterpretation of spirometry results was the prevailing factor leading to patients initially being misdiagnosed with COPD, affecting 59% of misdiagnosed patients in this cohort. Of the 99 patients who were investigated for their underlying diagnosis; 41% had normal spirometry and 40% had asthma. Further investigation through qualitative methodology uncovered reluctance to challenge historical misdiagnoses and challenges in differential diagnosis as the underlying explanations for COPD misdiagnosis in this cohort., Conclusions: Patients historically diagnosed with COPD without spirometric evidence are at risk of remaining labelled and treated for COPD despite non-obstructive respiratory physiology, leading to a persistent cohort of patients misdiagnosed with COPD in primary care. The lack of spirometry services during and after the COVID19 pandemic in primary care risks adding to the cohort of misdiagnosed patients. Support from respiratory specialists can potentially help to reduce the prevalence of COPD misdiagnosis in primary care., Trial Registration: NCT03482700., Competing Interests: The authors have read the journal’s policy and have the following competing interests: AMT and KP were supported financially in relation to this study through a non-commercial grant from AstraZeneca. AMT has received grants not in relation to this study from Chiesi, NIHR ARC & PSRC, CSL Behring and Grifols Biotherapeutics. DJS, CCH, SDC, AP, APD and NG declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Patel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Studies in hospital settings demonstrate that there is greater guideline adherence when care is delivered by a respiratory specialist, however, this has not been explored in primary care. The aim of this study is to determine the impact integrating respiratory specialists into primary care has on the delivery of guideline adherent chronic obstructive pulmonary disease (COPD) care., Methods: 18 general practitioner (GP) practices were randomised to provide either usual or specialist-led COPD care. Patients at participating practices were included if they had an existing diagnosis of COPD. Outcomes were measured at the individual patient level. The primary outcome was guideline adherence, assessed as achieving four or more items of the COPD care bundle. Secondary outcome measures included quality of life, number of exacerbations, number of COPD-related hospitalisations and respiratory outpatient attendances., Results: 586 patients from 10 practices randomised to the intervention and 656 patients from 8 practices randomised to the control arm of the study were included. The integration of respiratory specialists into GP practices led to a statistically significant (p<0.001) improvement in the provision of guideline adherent care when compared with usual care in this cohort (92.7% vs 70.1%) (OR 4.14, 95% CI 2.14 to 8.03)., Conclusion: This is the first study to demonstrate that guideline adherence is improved through the integration of respiratory specialists into GP practices to deliver annual COPD reviews. To facilitate changes in current healthcare practice and policy, the findings of this paper need to be viewed in combination with qualitative research exploring the acceptability of specialist integration., Trial Registration Number: NCT03482700., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ (available on request from the corresponding author). AMT and KP were supported financially in relation to this study through a non-commercial grant from AstraZeneca. AMT has received grants not in relation to this study from Chiesi, NIHR, CSL Behring and Grifols Biotherapeutics. AS has received support from Birmingham NIHR Biomedical Research Centre. AP, PRE, RGE, HB and APD declare no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Effective stakeholder engagement in health research is increasingly being recognised and promoted as an important pathway to closing the gap between knowledge production and its use in health systems. However, little is known about its process and impacts, particularly in low-and middle-income countries. This opinion piece draws on the stakeholder engagement experiences from a global health research programme on Chronic Obstructive Pulmonary Disease (COPD) led by clinician researchers in Brazil, China, Georgia and North Macedonia, and presents the process, outcomes and lessons learned., Main Body: Each country team was supported with an overarching engagement protocol and mentored to develop a tailored plan. Patient involvement in research was previously limited in all countries, requiring intensive efforts through personal communication, meetings, advisory groups and social media. Accredited training programmes were effective incentives for participation from healthcare providers; and aligning research findings with competing policy priorities enabled interest and dialogue with decision-makers. The COVID-19 pandemic severely limited possibilities for planned engagement, although remote methods were used where possible. Planned and persistent engagement contributed to shared knowledge and commitment to change, including raised patient and public awareness about COPD, improved skills and practice of healthcare providers, increased interest and support from clinical leaders, and dialogue for integrating COPD services into national policy and practice., Conclusion: Stakeholder engagement enabled relevant local actors to produce and utilise knowledge for small wins such as improving day-to-day practice and for long-term goals of equitable access to COPD care. For it to be successful and sustained, stakeholder engagement needs to be valued and integrated throughout the research and knowledge generation process, complete with dedicated resources, contextualised and flexible planning, and commitment., (© 2024. The Author(s).)

Communication is a core component of a clinician's role; however, when clinicians conduct research, communicating the emerging findings and recommendations to different types of stakeholders can be unfamiliar territory. Communicating research to advocate for change can be even more challenging. Clinician researchers seeking to be agents for change need to conceive and craft specific, evidence-based messages and communicate these effectively to different stakeholders to negotiate action. As part of a global health research program, we developed and tested a novel game-based model to strengthen the communication skills of clinician researchers, from 4 countries, for improving services for chronic obstructive pulmonary disease. This model focused on communication with 3 key stakeholder groups for knowledge translation: Patients/carers, healthcare providers and policy makers/healthcare managers. Delivered through a series of facilitated, online meetings, this model consisted of 2 parts: developing and rehearsing advocacy messages with coaching support, and then testing them with a panel of 3 representative stakeholders, and an audience of fellow researchers. All the country teams reported increased confidence in crafting advocacy messages for specific stakeholders and have applied lessons learned from the model. Delivering this model within a global health research program requires mentoring, time, commitment, resources and translation support to address language barriers. It offers an exemplar to build the communication skills of clinician and non-clinician researchers so that they can go beyond dissemination toward translation of evidence into policy and practice., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J Correia-De-Sousa declares grant funding to his institution from AstraZeneca and GSK, advisory board and consulting fees paid to himself from Boheringer Ingelheim, GSK, AstraZeneca, Bial, Medinfar, Payment for lectures from GSK, AstraZeneca and Sanofi Pasteur, support for attending meetings from Mundipharma and Mylan, leadership role for International Primary Care Respiratory Group (IPCRG); A Dickens declares grant funding paid to his institution from NIHR GHR for current manuscript; A Farley declares grant funding paid to her institution from NIHR GHR for the present manuscript, grant funding from NIHR HTA, NIHR EME, MRC and Ethicon (Johnson and Johnson) for other work, membership on DMEC for NIHR funded e-cigarette trial (no honorarium), leadership role for International Primary Care Respiratory Group (IPCRG); R Jordan declares grant funding to her institution from NIHR, membership of Boehringer Ingelheim Primary Care Advisory Board, leadership role for International Primary Care Respiratory Group (IPCRG)—research sub-committee; S Martins declares leadership or fiduciary role in Brazilian Society of Medicine and Family and Community; ABC School of Medicine, GEPRAPS ( respiratory group of study and research in primary care), IPCRG (International Primary Care Respiratory Group); A Sitch declares grant funding to her institution from NIHR GHR for present manuscript, NIHR Birmingham BRC and AstraZeneca; A Turner declares grant funding to her institution from NIHR GHR for present manuscript, grant funding from AstraZeneca and Chiesi for other work, payment of honoraria from GSK and Boehringer, support for attending meetings and/or travel from AstraZeneca and Chiesi; S Williams declares grants from the University of Birmingham paid to her institution; G Fernandes, P Adab, R Adams, C Chi, A Enocson, T Maghlakelidze, M Maglakelidze, A Stamenova, K Stavrikj, R Stelmach, Z Pan, H Pang, and J Zhang have no conflicts to declare.

Introduction: In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care., Methods: We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia. All participants who decided to attempt to quit smoking were advised about accessing smoking cessation medications and were also offered behavioural support as part of the "ACT" component of VBA. Participants were aged ≥ 35 years, smoked ≥ 10 cigarettes per day, were recruited from 31 GP practices regardless of motivation to quit and were randomised (1:1:1) using a sequence generated before the start of recruitment. The primary outcome was biochemically validated 7-day point prevalence abstinence at 4 weeks (wks). Participants and GPs were not blinded to allocation after randomisation, however outcome assessors were blind to treatment allocation., Results: There was no evidence of a difference in biochemically confirmed quitting between intervention and control at 4wks (VBA + LA RR 0.90 (97.5%CI: 0.35, 2.27); VBA + CO RR 1.04 (97.5%CI: 0.44, 2.44)), however the absolute number of quitters was small (VBA + LA 1.6%, VBA + CO 1.8%, VBA 1.8%). A similar lack of effect was observed at 12 and 26wks, apart from in the VBA + LA arm where the point estimate was significant but the confidence intervals were very wide. In both treatment arms, a larger proportion reported a reduction in cigarettes smoked per day at 4wks (VBA + LA 1.30 (1.10, 1.54); VBA + CO 1.23 (1.03, 1.49)) compared with VBA. The point estimates indicated a similar direction of effect at 12wks and 26wks, but differences were not statistically significant. Quantitative process measures indicated high fidelity to the intervention delivery protocols, but low uptake of behavioural and pharmacological support. VBA was the dominant intervention in the health economic analyses., Conclusion: Overall, there was no evidence that adding LA or CO to VBA increased quit rates. However, a small effect cannot be ruled out as the proportion quitting was low and therefore estimates were imprecise. There was some evidence that participants in the intervention arms were more likely to reduce the amount smoked, at least in the short term. More research is needed to find effective ways to support quitting in settings like North Macedonia where a strong smoking culture persists., Trial Registration: The trial was registered at http://www.isrctn.com (ISRCTN54228638) on the 07/09/2018., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: This study compared management of high-risk COPD patients in the UK to national and international management recommendations and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). The primary comparison was in 2019, but trends from 2000 to 2019 were also examined., Methods: Patients identified in the Optimum Patient Care Research Database were categorised as newly diagnosed (≤12 months after diagnosis), already diagnosed, and potential COPD (smokers having exacerbation-like events). High-risk patients had a history of ≥2 moderate or ≥1 severe exacerbations in the previous 12 months., Findings: For diagnosed patients, the median time between diagnosis and first meeting the high-risk criteria was 617 days (Q1-Q3: 3246). The use of spirometry for diagnosis increased dramatically after 2004 before plateauing and falling in recent years. In 2019, 41% (95% CI 39-44%; n = 550/1343) of newly diagnosed patients had no record of spirometry in the previous year, and 45% (95% CI 43-48%; n = 352/783) had no record of a COPD medication review within 6 months of treatment initiation or change. In 2019, 39% (n = 6893/17,858) of already diagnosed patients had no consideration of exacerbation rates, 46% (95% CI 45-47%; n = 4942/10,725) were not offered or referred for pulmonary rehabilitation, and 41% (95% CI 40-42%; n = 3026/7361) had not had a COPD review within 6 weeks of respiratory hospitalization., Interpretation: Opportunities for early diagnosis of COPD patients at high risk of exacerbations are being missed. Newly and already diagnosed patients at high-risk are not being assessed or treated promptly. There is substantial scope to improve the assessment and treatment optimisation of these patients., Funding: This study is conducted by the Observational & Pragmatic Research International Ltd and was co-funded by Optimum Patient Care and AstraZeneca. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution., Competing Interests: David MG Halpin has received sponsorship to attend international meetings, and honoraria for lecturing, attending advisory boards and preparing educational materials from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis and Pfizer. Andrew P. Dickens, Rachel Pullen, and Amy Couper, are employees of the Observational and Pragmatic Research Institute, which is a research collaborator of the CONQUEST initiative with Optimum Patient Care and AstraZeneca. Alexander Evans, Victoria Carter, Derek Skinner and Ruth Murray are employees of Optimum Patient Care, UK, which is a research collaborator of the CONQUEST initiative with Optimum Patient Care and AstraZeneca. Mukesh Singh reports personal fees from AstraZeneca, Boehringer Ingelheim, Cheisi, GlaxoSmithKline, Napp/Mundipharma, Pfizer, Teva. Tamsin Morris, Shruti Menon and Hana Muellerova are employees of AstraZeneca and hold stock and/or stock options in the company. AstraZeneca is a co-funder of the CONQUEST initiative. Mona Bafadhel reports grants from AstraZeneca and personal fees and non-financial support from AstraZeneca, Chiesi, GSK and others from AlbusHealth, outside the submitted work. James Chalmers has received research grants or consultancy fees from AstraZeneca, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Grifols, Insmed and Zambon. Katherine Hickman, Graham Devereux, Martin Gibson, Jennifer Quint, and Marije van Melle report no conflicts of interest. John Hurst has received personal payment and payment to his institution (UCL), including research grants, reimbursement for advisory work and educational activities, and support to attend meetings from pharmaceutical companies that make medicines to treat COPD, which includes AstraZeneca, Boehringer Ingelheim, Chiesi, and Novartis. Rupert C. Jones declares grants from AstraZeneca, GlaxoSmithKline, Novartis, and Teva, and personal fees for consultancy, speakers’ fees or travel support from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Observational & Pragmatic Research Institute Pte Ltd (OPRI). Konstantinos Kostikas has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, CSL Behring, Chiesi, ELPEN, GILEAD, GSK, Menarini, Novartis, Sanofi, Specialty Therapeutics; WebMD (paid to the University of Ioannina); his department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir (paid to the University of Ioannina); KK is a member of the GOLD Assembly. Dave Singh has received personal fees from GSK, Cipla, Genentech and Peptinnovate, and personal fees and grant support from AstraZeneca, Boehringer Ingelheim, Chiesi, Glenmark, Gossamerbio, Menarini, Mundipharma, Novartis, Pfizer, Pulmatrix, Theravance, and Verona. Tom Wilkinson is the co-founder, shareholder and director of Mymhealth Limited; he has received grants or consultancy fees from GSK, AstraZeneca, Janssen, Bergenbio, UCB, Olam, Valneva, Synairgen, Novavax, Teva, BI. David Price has advisory board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline., (© 2023 The Author(s).)

In Brazil, prevalence of diagnosed COPD among adults aged 40 years and over is 16% although over 70% of cases remain undiagnosed. Hypertension is common and well-recorded in primary care, and frequently co-exists with COPD because of common causes such as tobacco smoking, therefore we conducted a cross-sectional screening test accuracy study in nine Basic Health Units in Brazil, among hypertensive patients aged ≥40 years to identify the optimum screening test/combinations to detect undiagnosed COPD. We compared six index tests (four screening questionnaires, microspirometer and peak flow) against the reference test defined as those below the lower limit of normal (LLN-GLI) on quality diagnostic spirometry, with confirmed COPD at clinical review. Of 1162 participants, 6.8% (n = 79) had clinically confirmed COPD. Peak flow had a higher specificity but lower sensitivity than microspirometry (sensitivity 44.3% [95% CI 33.1, 55.9], specificity 95.5% [95% CI 94.1, 96.6]). SBQ performed well compared to the other questionnaires (sensitivity 75.9% [95% CI 65.0, 84.9], specificity 59.2% [95% CI 56.2, 62.1]). A strategy requiring both SBQ and peak flow to be positive yielded sensitivity of 39.2% (95% CI 28.4, 50.9) and specificity of 97.0% (95% CI 95.7, 97.9). The use of simple screening tests was feasible within the Brazilian primary care setting. The combination of SBQ and peak flow appeared most efficient, when considering performance of the test, cost and ease of use (costing £1690 (5554 R$) with 26.7 cases detected per 1,000 patients). However, the choice of screening tests depends on the clinical setting and availability of resources.ISRCTN registration number: 11377960., (© 2022. The Author(s).)

Objectives: To assess the feasibility of delivering a culturally tailored pulmonary rehabilitation (PR) programme and conducting a definitive randomised controlled trial (RCT)., Design: A two-arm, randomised feasibility trial with a mixed-methods process evaluation., Setting: Secondary care setting in Georgia, Europe., Participants: People with symptomatic spirometry-confirmed chronic obstructive pulmonary disease recruited from primary and secondary care., Interventions: Participants were randomised in a 1:1 ratio to a control group or intervention comprising 16 twice-weekly group PR sessions tailored to the Georgian setting., Primary and Secondary Outcome Measures: Feasibility of the intervention and RCT were assessed according to: study recruitment, consent and follow-up, intervention fidelity, adherence and acceptability, using questionnaires and measurements at baseline, programme end and 6 months, and through qualitative interviews., Results: The study recruited 60 participants (as planned): 54 (90%) were male, 10 (17%) had a forced expiratory volume in 1 second of ≤50% predicted. The mean MRC Dyspnoea Score was 3.3 (SD 0.5), and mean St George's Respiratory Questionnaire (SGRQ) 50.9 (SD 17.6). The rehabilitation specialists delivered the PR with fidelity. Thirteen (43.0%) participants attended at least 75% of the 16 planned sessions. Participants and rehabilitation specialists in the qualitative interviews reported that the programme was acceptable, but dropout rates were high in participants who lived outside Tbilisi and had to travel large distances. Outcome data were collected on 63.3% participants at 8 weeks and 88.0% participants at 6 months. Mean change in SGRQ total was -24.9 (95% CI -40.3 to -9.6) at programme end and -4.4 (95% CI -12.3 to 3.4) at 6 months follow-up for the intervention group and -0.5 (95% CI -8.1 to 7.0) and -8.1 (95% CI -16.5 to 0.3) for the usual care group at programme end and 6 months, respectively., Conclusions: It was feasible to deliver the tailored PR intervention. Approaches to improve uptake and adherence warrant further research., Trial Registration Number: ISRCTN16184185., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

COPD is increasingly common in China but is poorly understood by patients, medications are not used as prescribed and there is no access to recommended non-pharmacological treatment. We explored COPD patients' and general practitioners' (GPs) knowledge of COPD, views on its management and the acceptability of a flexible lung health service (LHS) offering health education, exercise, self-management, smoking cessation and mental health support. Using a convergent mixed methods design, data were collected from patients and GPs using focus groups (FGs) in four Chinese cities, questionnaires were also used to collect data from patients. FGs were audio-recorded and transcribed. Quantitative data were analysed descriptively, thematic framework analysis was used for the qualitative data. Two-hundred fifty-one patients completed the questionnaire; 39 patients and 30 GPs participated in ten separate FGs. Three overarching themes were identified: patients' lack of knowledge/understanding of COPD, current management of COPD not meeting patients' needs and LHS design, which was well received by patients and GPs. Participants wanted COPD education, TaiChi, psychological support and WeChat for social support. 39% of survey responders did not know what to do when their breathing worsened and 24% did not know how to use their inhalers. 36% of survey respondents requested guided relaxation. Overall, participants did not fully understand the implications of COPD and current treatment was sub-optimal. There was support for developing a culturally appropriate intervention meeting Chinese patients' needs, health beliefs, and local healthcare delivery. Further research should explore the feasibility of such a service., (© 2022. The Author(s).)

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use., Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research., Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance., Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans., Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Respiratory diseases remain a significant cause of global morbidity and mortality and primary care plays a central role in their prevention, diagnosis and management. An e-Delphi process was employed to identify and prioritise the current respiratory research needs of primary care health professionals worldwide. One hundred and twelve community-based physicians, nurses and other healthcare professionals from 27 high-, middle- and low-income countries suggested 608 initial research questions, reduced after evidence review by 27 academic experts to 176 questions covering diagnosis, management, monitoring, self-management and prognosis of asthma, COPD and other respiratory conditions (including infections, lung cancer, tobacco control, sleep apnoea). Forty-nine questions reached 80% consensus for importance. Cross-cutting themes identified were: a need for more effective training of primary care clinicians; evidence and guidelines specifically relevant to primary care, adaption for local and low-resource settings; empowerment of patients to improve self-management; and the role of the multidisciplinary healthcare team., (© 2022. The Author(s).)

Objectives: A respiratory bolt-on dimension for the EQ-5D-5L has recently been developed and valued by the general public. This study aimed to validate the EQ-5D-5L plus respiratory dimension (EQ-5D-5L+R) in a large group of patients with chronic obstructive pulmonary disease (COPD)., Methods: Validation was undertaken with data from the Birmingham COPD Cohort Study, a longitudinal UK study of COPD primary care patients. Data on the EQ-5D-5L+R were collected from 1008 responding participants during a follow-up questionnaire in 2017 and combined with (previously collected) data on patient and disease characteristics. Descriptive and correlation analyses were performed on the EQ-5D-5L+R dimensions and utilities, in relation to COPD characteristics and compared with the EQ-5D-5L without respiratory dimension. Multivariate regression models were estimated to test whether regression coefficients of clinical characteristics differed between the EQ-5D-5L+R utility and the EQ-5D-5L utility., Results: Correlation coefficients for the EQ-5D-5L+R utility with COPD parameters were slightly higher than the EQ-5D-5L utility. Both instruments displayed discriminant validity but analyses in clinical subgroups of patients showed larger absolute differences in utilities for the EQ-5D-5L+R. In the multivariate analyses, only the coefficient for the COPD Assessment Test score was higher for the model using the EQ-5D-5L+R utility as outcome., Conclusions: This study showed that the addition of a respiratory domain to the EQ-5D-5L led to small improvements in the instrument's performance. Comparability of the EQ-5D across diseases, currently considered one of its strengths, would have to be traded off against a modest improvement in utility difference when adding the respiratory dimension., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objectives: To examine the accuracy and cost-effectiveness of various chronic obstructive pulmonary disease (COPD) screening tests and combinations within a Chinese primary care population., Design: Screening test accuracy study., Setting: Urban and rural community health centres in four municipalities of China: Beijing (north), Chengdu (southwest), Guangzhou (south) and Shenyang (northeast)., Participants: Community residents aged 40 years and above who attended community health centres for any reason were invited to participate. 2445 participants (mean age 59.8 (SD 9.6) years, 39.1% (n=956) male) completed the study (February-December 2019), 68.9% (n=1684) were never-smokers and 3.6% (n=88) had an existing COPD diagnosis. 13.7% (n=333) of participants had spirometry-confirmed airflow obstruction., Interventions: Participants completed six index tests (screening questionnaires (COPD Diagnostic Questionnaire, COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE), Chinese Symptom-Based Questionnaire (C-SBQ), COPD-SQ), microspirometry (COPD-6), peak flow (model of peak flow meters used in the study (USPE)) and the reference test (ndd Easy On-PC)., Primary and Secondary Outcomes: Cases were defined as those with forced expiratory volume in one second (FEV 1 )/forced vital capacity (FVC) below the lower limit of normal (LLN-GLI) on the reference test. Performance of individual screening tests and their combinations was evaluated, with cost-effectiveness analyses providing cost per additional true case detected., Results: Airflow measurement devices (sensitivities 64.9% (95% CI 59.5% to 70.0%) and 67.3% (95% CI 61.9% to 72.3%), specificities 89.7% (95% CI 88.4% to 91.0%) and 82.6% (95% CI 80.9% to 84.2%) for microspirometry and peak flow, respectively) generally performed better than questionnaires, the most accurate of which was C-SBQ (sensitivity 63.1% (95% CI 57.6% to 68.3%) specificity 74.2% (95% CI 72.3% to 76.1%)). The combination of C-SBQ and microspirometry used in parallel maximised sensitivity (81.4%) (95% CI 76.8% to 85.4%) and had specificity of 68.0% (95% CI 66.0% to 70.0%), with an incremental cost-effectiveness ratio of £64.20 (CNY385) per additional case detected compared with peak flow., Conclusions: Simple screening tests to identify undiagnosed COPD within the primary care setting in China is possible, and a combination of C-SBQ and microspirometry is the most sensitive and cost-effective. Further work is required to explore optimal cut-points and effectiveness of programme implementation., Trial Registration Number: ISRCTN13357135., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The latest chronic obstructive pulmonary disease (COPD) epidemiology survey in China estimated that there were 99 million potential COPD patients in the country, the majority of whom are undiagnosed. Screening for COPD in primary care settings is of vital importance for China, but it is not known which strategy would be the most suitable for adoption in primary care. Studies have been conducted to test the accuracy of questionnaires, expiratory peak flow meters and microspirometers to screen for COPD, but no study has directly evaluated and compared the effectiveness and cost-effectiveness of these methods in the Chinese setting., Methods and Analysis: We present the protocol for a multicentre cross-sectional study, to be conducted in eight community hospitals from four cities among Chinese adults aged 40 years or older to investigate the effectiveness and cost-effectiveness of different case-finding methods for COPD, and determine the test performance of individual and combinations of screening tests and strategies in comparison with quality diagnostic spirometry. Index tests are screening questionnaires (COPD Diagnostic Questionnaire (CDQ), COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk Questionnaire (CAPTURE), symptom-based questionnaire, COPD Screening Questionnaire (COPD-SQ)), microspirometer and peak flow. Each participant will complete all of these tests in one assessment. The primary analysis will compare the performance of a screening questionnaire with a handheld device. Secondary analyses will include the comparative performance of each index test, as well as a comparison of strategies where we use a screening questionnaire and a handheld device. Approximately 2000 participants will be recruited over 9 to 12 months., Ethics and Dissemination: The study has been approved by Peking University Hospital and University of Birmingham. All study participants will provide written informed consent. Study results will be published in appropriate journal and presented at national and international conferences, as well as relevant social media and various community/stakeholder engagement activities., Trial Registration Number: ISRCTN13357135., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To investigate the impact of chronic obstructive pulmonary disease (COPD) case finding on clinical care., Design: We conducted a prospective observational analysis of data from a pragmatic cluster randomised controlled trial in primary care in the West Midlands, UK (TargetCOPD). This compared alternative methods of COPD case finding against usual care. Data were extracted from electronic healthcare records and self-reported questionnaires for a subset of patients with newly diagnosed COPD., Setting: 50 general practices that participated in the TargetCOPD trial., Participants: Patients aged 40-79 years newly identified with COPD by targeted case finding or by usual care, from 10 August 2012 to 22 June 2014., Primary and Secondary Outcome Measures: The primary outcome was addition to a COPD register by the end of the trial. The secondary outcome was a clinical care score, derived from the sum of clinical assessments and relevant interventions. Associations between participant characteristics and the primary and secondary outcomes were assessed using multilevel regression., Results: 857 patients identified with COPD by case finding and 764 by usual care were included. Only 21.2% of case-found patients had been added to a COPD register, compared with 92.7% of those diagnosed by usual care. The odds of being added were greater in smokers (adjusted OR 8.68, 95% CI 2.53 to 29.8), and in those with lower percentage of predicted forced expiratory volume in 1 s (adjusted OR 0.96 per percentage rise, 95% CI 0.95 to 0.98). Patients who had been added to a COPD register had a significantly higher clinical care score (mean difference 5.06, 95% CI 4.36 to 5.75)., Conclusions: Only one in five case-found patients had been registered with COPD. Patients added to a COPD register received significantly higher levels of appropriate clinical care., Trial Registration Number: ISRCTN14930255; Post-results., Competing Interests: Competing interests: PA, REJ and DAF were principle investigators for the Birmingham Lung Improvement StudieS (BLISS) programme, funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research (grant reference number RP-PG-0109-10061). We report grants from various NIHR studies. PA is the Chair of the NIHR Public Health Research (PHR) Funding committee., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

Microspirometry may be useful as the second stage of a screening pathway among patients reporting respiratory symptoms. We assessed sensitivity and specificity of the Vitalograph® lung monitor compared with post-bronchodilator confirmatory spirometry (ndd Easy on-PC) among primary care chronic obstructive pulmonary disease (COPD) patients within the Birmingham COPD cohort. We report a case-control analysis within 71 general practices in the UK. Eligible patients were aged ≥40 years who were either on a clinical COPD register or reported chronic respiratory symptoms on a questionnaire. Participants performed pre- and post-bronchodilator microspirometry, prior to confirmatory spirometry. Out of the 544 participants, COPD was confirmed in 337 according to post-bronchodilator confirmatory spirometry. Pre-bronchodilator, using the LLN as a cut-point, the lung monitor had a sensitivity of 50.5% (95% CI 45.0%, 55.9%) and a specificity of 99.0% (95% CI 96.6%, 99.9%) in our sample. Using a fixed ratio of FEV 1 /FEV 6  < 0.7 to define obstruction in the lung monitor, sensitivity increased (58.8%; 95% CI 53.0, 63.8) while specificity was virtually identical (98.6%; 95% CI 95.8, 99.7). Within our sample, the optimal cut-point for the lung monitor was FEV 1 /FEV 6  < 0.78, with sensitivity of 82.8% (95% CI 78.3%, 86.7%) and specificity of 85.0% (95% CI 79.4%, 89.6%). Test performance of the lung monitor was unaffected by bronchodilation. The lung monitor could be used in primary care without a bronchodilator using a simple ratio of FEV 1 /FEV 6 as part of a screening pathway for COPD among patients reporting respiratory symptoms.

Self-management support for chronic obstructive pulmonary disease (COPD) patients is recommended by UK national guidelines, but extent of implementation is unknown. We aimed to describe self-management behaviour and support among COPD patients and explore behaviour associated with having a self-management plan. We undertook cross-sectional analysis of self-reported data from diagnosed COPD patients in the Birmingham COPD Cohort study. Questionnaire items relevant to self-management behaviour, knowledge of COPD, receipt of self-management plans and advice from healthcare professionals were examined. Multiple regression models were used to identify behaviour associated with having a self-management plan. One-thousand seventy-eight participants (676 males, 62.7%, mean age 69.8 (standard deviation 9.0) years) were included. The majority reported taking medications as instructed (940, 94.0%) and receiving annual influenza vaccinations (962, 89.2%). Only 400 (40.4%) participants had self-management plans, 538 (49.9%) reported never having received advice on diet/exercise and 110 (42.7%) current smokers had been offered practical help to stop smoking in the previous year. General knowledge about COPD was moderate (mean total Bristol COPD Knowledge Questionnaire score: 31.5 (standard deviation 10.7); max score 65), corresponding to 48.5% of questions answered correctly. Having a self-management plan was positively associated with self-reported adherence to medication (odds ratio 3.10, 95% confidence interval 1.43 to 6.72), attendance at a training course (odds ratio 2.72, 95% confidence interval 1.81 to 4.12), attendance at a support group (odds ratio 6.28, 95% confidence interval 2.96 to 13.35) and better disease knowledge (mean difference 4.87, 95% confidence interval 3.16 to 6.58). Primary care healthcare professionals should ensure more widespread implementation of individualised self-management plans for all patients and improve the lifestyle advice provided., Chronic Lung Disease: CALL FOR WIDER IMPLEMENTATION OF SELF-MANAGEMENT PLANS: Health professionals should ensure all patients with chronic lung disease receive individualized self-management plans and lifestyle advice. UK national guidelines state that patients with chronic obstructive pulmonary disease (COPD) should receive personalized self-management plans and comprehensive support to help them manage their disease. Ainee Khan and colleagues at the University of Birmingham analyzed patient questionnaire data gathered during the Birmingham COPD Cohort study to explore self-management behavior, receipt of self-management plans and advice, and patient knowledge of COPD. Of 1,078 participants, only 400 had self-management plans, and less than half reported receiving lifestyle advice or support. Those with plans were more likely to adhere to medication, had greater knowledge about COPD and were more likely to attend support groups and training courses. The authors recommend carefully-planned, wider implementation of COPD self-management plans and associated support.

Background: Volunteering has been advocated by the United Nations, and American and European governments as a way to engage people in their local communities and improve social capital, with the potential for public health benefits such as improving wellbeing and decreasing health inequalities. Furthermore, the US Corporation for National and Community Service Strategic Plan for 2011-2015 focused on increasing the impact of national service on community needs, supporting volunteers' wellbeing, and prioritising recruitment and engagement of underrepresented populations. The aims of this review were to examine the effect of formal volunteering on volunteers' physical and mental health and survival, and to explore the influence of volunteering type and intensity on health outcomes., Methods: Experimental and cohort studies comparing the physical and mental health outcomes and mortality of a volunteering group to a non-volunteering group were identified from twelve electronic databases (Cochrane Library, Medline, Embase, PsychINFO, CINAHL, ERIC, HMIC, SSCI, ASSIA, Social Care Online, Social Policy and Practice) and citation tracking in January 2013. No language, country or date restrictions were applied. Data synthesis was based on vote counting and random effects meta-analysis of mortality risk ratios., Results: Forty papers were selected: five randomised controlled trials (RCTs, seven papers); four non-RCTs; and 17 cohort studies (29 papers). Cohort studies showed volunteering had favourable effects on depression, life satisfaction, wellbeing but not on physical health. These findings were not confirmed by experimental studies. Meta-analysis of five cohort studies found volunteers to be at lower risk of mortality (risk ratio: 0.78; 95% CI: 0.66, 0.90). There was insufficient evidence to demonstrate a consistent influence of volunteering type or intensity on outcomes., Conclusion: Observational evidence suggested that volunteering may benefit mental health and survival although the causal mechanisms remain unclear. Consequently, there was limited robustly designed research to guide the development of volunteering as a public health promotion intervention. Future studies should explicitly map intervention design to clear health outcomes as well as use pragmatic RCT methodology to test effects.

Background: Targeting social isolation in older people is a growing public health concern. The proportion of older people in society has increased in recent decades, and it is estimated that approximately 25% of the population will be aged 60 or above within the next 20 to 40 years. Social isolation is prevalent amongst older people and evidence indicates the detrimental effect that it can have on health and wellbeing. The aim of this review was to assess the effectiveness of interventions designed to alleviate social isolation and loneliness in older people., Methods: Relevant electronic databases (MEDLINE, EMBASE, ASSIA, IBSS, PsycINFO, PubMed, DARE, Social Care Online, the Cochrane Library and CINAHL) were systematically searched using an extensive search strategy, for randomised controlled trials and quasi-experimental studies published in English before May 2009. Additional articles were identified through citation tracking. Studies were included if they related to older people, if the intervention aimed to alleviate social isolation and loneliness, if intervention participants were compared against inactive controls and, if treatment effects were reported. Two independent reviewers extracted data using a standardised form. Narrative synthesis and vote-counting methods were used to summarise and interpret study data., Results: Thirty two studies were included in the review. There was evidence of substantial heterogeneity in the interventions delivered and the overall quality of included studies indicated a medium to high risk of bias. Across the three domains of social, mental and physical health, 79% of group-based interventions and 55% of one-to-one interventions reported at least one improved participant outcome. Over 80% of participatory interventions produced beneficial effects across the same domains, compared with 44% of those categorised as non-participatory. Of interventions categorised as having a theoretical basis, 87% reported beneficial effects across the three domains compared with 59% of interventions with no evident theoretical foundation. Regarding intervention type, 86% of those providing activities and 80% of those providing support resulted in improved participant outcomes, compared with 60% of home visiting and 25% of internet training interventions. Fifty eight percent of interventions that explicitly targeted socially isolated or lonely older people reported positive outcomes, compared with 80% of studies with no explicit targeting., Conclusions: More, well-conducted studies of the effectiveness of social interventions for alleviating social isolation are needed to improve the evidence base. However, it appeared that common characteristics of effective interventions were those developed within the context of a theoretical basis, and those offering social activity and/or support within a group format. Interventions in which older people are active participants also appeared more likely to be effective. Future interventions incorporating all of these characteristics may therefore be more successful in targeting social isolation in older people.

The physiologically active form of vitamin D, 1,25-dihydroxyvitamin D(3), is a fat-soluble steroid hormone with a well established role in skeletal health. A growing body of evidence suggests low vitamin D levels also play a role in the pathogenesis of a wide range of non-skeletal, age-associated diseases including cancer, heart disease, type 2 diabetes mellitus and stroke. Low levels of serum 25-hydroxyvitamin D [25(OH)D], a stable marker of vitamin D status, are also associated with increased odds of prevalent cognitive dysfunction, Alzheimer's disease and all-cause dementia in a number of studies, raising the possibility that vitamin D plays a role in the aetiology of cognitive dysfunction and dementia. To date, the majority of human studies reporting associations between vitamin D and cognition or dementia have been cross-sectional or case-control designs that do not permit us to exclude the possibility that such associations are a result of disease progression rather than being causal. Animal and in vitro experiments have identified a number of neuroprotective mechanisms that might link vitamin D status to cognitive dysfunction and dementia, including vasoprotection and amyloid phagocytosis and clearance, but the clinical relevance of these mechanisms in humans is not currently clear. Two recent, large, prospective studies go some way to establish the temporal relationship with cognitive decline. The relative risk of cognitive decline was 60% higher (relative risk = 1.6, 95% CI 1.2, 2.0) in elderly Italian adults with severely deficient 25(OH)D levels (<25 nmol/L) when compared with those with sufficient levels (≥75 nmol/L). Similarly, the odds of cognitive decline were 41% higher (odds ratio = 1.4, 95% CI 0.9, 2.2) when elderly US men in the lowest quartile (≤49.7 nmol/L) were compared with those in the highest quartile (≥74.4 nmol/L). To our knowledge, no prospective studies have examined the association between 25(OH)D levels and incident dementia or neuroimaging abnormalities. The possible therapeutic benefits of vitamin D have attracted considerable interest as over 1 billion people worldwide are thought to have insufficient 25(OH)D levels and these levels can be increased using inexpensive and well tolerated dietary supplements. However, no large randomized controlled trials have yet examined the effect of vitamin D supplements on cognitive decline or incident dementia. Further studies are urgently needed to establish which mechanisms have clinical relevance in human populations and whether vitamin D supplements are effective at minimizing cognitive decline or preventing dementia.

Background: Social isolation affects a significant proportion of older people and is associated with poor health outcomes. The current evidence base regarding the effectiveness of interventions targeting social isolation is poor, and the potential utility of mentoring for this purpose has not previously been rigorously evaluated. The purpose of this study was to examine the effectiveness of a community-based mentoring service for improving mental health, social engagement and physical health for socially isolated older people., Methods: This prospective controlled trial compared a sample of mentoring service clients (intervention group) with a matched control group recruited through general practice. One hundred and ninety five participants from each group were matched on mental wellbeing and social activity scores. Assessments were conducted at baseline and at six month follow-up. The primary outcome was the Short Form Health Survey v2 (SF-12) mental health component score (MCS). Secondary outcomes included the SF-12 physical health component score (PCS), EuroQol EQ-5D, Geriatric Depression Score (GDS-10), social activity, social support and morbidities., Results: We found no evidence that mentoring was beneficial across a wide range of participant outcomes measuring health status, social activity and depression. No statistically significant between-group differences were observed at follow-up in the primary outcome (p = 0.48) and in most secondary outcomes. Identifying suitable matched pairs of intervention and control group participants proved challenging., Conclusions: The results of this trial provide no substantial evidence supporting the use of community mentoring as an effective means of alleviating social isolation in older people. Further evidence is needed on the effectiveness of community-based interventions targeting social isolation. When using non-randomised designs, there are considerable challenges in the recruitment of suitable matches from a community sample., Trial Registration: SCIE Research Register for Social Care 105923.

Purpose: To investigate for socially isolated older people, and older people at risk of social isolation: (1) health status and health-related quality of life (HRQL); (2) the relationship between social isolation and health status/HRQL; (3) the relationship between two alternative measures of health status/HRQL., Methods: Older people at risk of social isolation (n = 393) completed the EQ-5D and the SF-12. Multiple regression analyses were performed to examine the relationship between levels of social isolation and health status/HRQL, controlling for demographic/clinical characteristics. The agreement between EQ-5D and SF-6D (SF-12) scores was explored using descriptive psychometric techniques., Results: Health status and health state values were much lower than UK general population age-matched norms. After controlling for depression, physical co-morbidities, age, gender, living alone status, employment and accommodation, social isolation was significantly associated, to a degree that was clinically relevant, with EQ-5D DSI, SF-6D (SF-12) and SF-12 MCS scores. The potential for ceiling effects on the EQ-5D with this population was identified., Conclusion: This work highlights the burden that social isolation may have on the health and well-being of older people. The potential HRQL gains from addressing social isolation may be considerable, with those at risk of social isolation also a key target group.