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Article ; Online: A randomised, controlled, feasibility trial of an online, self-guided breathlessness supportive intervention (SELF-BREATHE) for individuals with chronic breathlessness due to advanced disease

Charles C. Reilly / Matthew Maddocks / Trudie Chalder / Katherine Bristowe / Irene J. Higginson

ERJ Open Research, Vol 9, Iss

2023 Volume 2

Abstract: Introduction SELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic ... ...

Abstract	Introduction SELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic breathlessness using nonpharmacological, self-management approaches. This study aimed to determine whether SELF-BREATHE is feasible to deliver and acceptable to patients living with chronic breathlessness. Methods A parallel, two-arm, single-blind, single-centre, randomised controlled, mixed-methods feasibility trial with participants allocated to 1) intervention group (SELF-BREATHE) or 2) control group (usual National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The a priori progression criteria were ≥30% of eligible patients given an information sheet consented to participate; ≥60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ≥70% of patients reported the methodology and intervention as acceptable. Results Between January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±sd (range) 9±8 (1–33) times over 6 weeks. 36 (70%) of the 52 randomised participants completed and returned the end-of-study postal questionnaires. SELF-BREATHE users reported it to be acceptable. Post-intervention qualitative interviews demonstrated that SELF-BREATHE was acceptable and valued by users, improving breathlessness during daily life and at points of breathlessness crisis. Conclusion These data support the feasibility of moving to a fully powered, randomised ...
Keywords	Medicine ; R
Subject code	796
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: “You can do it yourself and you can do it at your convenience”

Charles C. Reilly / Katherine Bristowe / Anna Roach / Matthew Maddocks / Irene J. Higginson

ERJ Open Research, Vol 8, Iss

internet accessibility and willingness of people with chronic breathlessness to use an internet-based breathlessness self-management intervention during the COVID-19 pandemic

2022 Volume 1

Abstract: Introduction The burden of chronic breathlessness on individuals, family, society and health systems is significant, and set to increase exponentially with population ageing, complex multimorbidity and coronavirus disease 2019 (COVID-19)-related ... ...

Abstract	Introduction The burden of chronic breathlessness on individuals, family, society and health systems is significant, and set to increase exponentially with population ageing, complex multimorbidity and coronavirus disease 2019 (COVID-19)-related disability. Breathlessness support services are effective; however, reach and access are limited. Delivering online breathlessness interventions may build capacity and resilience within health systems to tackle chronic breathlessness through supported self-management. The aim of this study was to explore accessibility and willingness of patients with chronic breathlessness to use an internet-based breathlessness self-management intervention (SELF-BREATHE). Methods Semi-structured telephone interviews were conducted with adults living with advanced malignant and non-malignant disease and chronic breathlessness (July to November 2020). Interviews were analysed using conventional and summative content analysis. Results 25 patients (COPD: n=13; lung cancer: n=8; interstitial lung disease (ILD): n=3; bronchiectasis: n=1) were interviewed: 17 male, median (range) age 70 (47–86) years and Medical Research Council dyspnoea score 3 (2–5). 21 patients had internet access. Participants described greater use, acceptance and normalisation of the internet since the advent of the COVID-19 pandemic. They described multifaceted internet use: functional, self-investment (improving health and wellbeing) and social. The concept of SELF-BREATHE was highly valued, and most participants with internet access were willing to use it. In addition to technical limitations, personal choice and perceived value of the internet were important factors that underpinned readiness to use online resources. Conclusion These findings suggest that patients living with chronic breathlessness that have access to the internet would have the potential to benefit from the online SELF-BREATHE intervention, if given the opportunity.
Keywords	Medicine ; R
Subject code	303
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: “The whole of humanity has lungs, doesn't it? We are not all the same sort of people”

Charles C. Reilly / Katherine Bristowe / Anna Roach / Trudie Chalder / Matthew Maddocks / Irene J. Higginson

ERJ Open Research, Vol 8, Iss

patient preferences and choices for an online, self-guided chronic breathlessness supportive intervention: SELF-BREATHE

2022 Volume 3

Abstract: Introduction The burden of chronic breathlessness on individuals, family, society and health systems is significant and set to increase exponentially with an ageing population with complex multimorbidity, yet there is a lack of services. This has been ... ...

Abstract	Introduction The burden of chronic breathlessness on individuals, family, society and health systems is significant and set to increase exponentially with an ageing population with complex multimorbidity, yet there is a lack of services. This has been further amplified by the coronavirus disease 2019 pandemic. Online breathlessness interventions have been proposed to fill this gap, but need development and evaluation based on patient preferences and choices. This study aimed to explore the preferences and choices of patients regarding the content of an online self-guided chronic breathlessness supportive intervention (SELF-BREATHE). Methods Semi-structured telephone interviews were conducted with adults living with advanced malignant and nonmalignant disease and chronic breathlessness (July to November 2020). Interviews were analysed using conventional and summative content analysis. Results 25 patients with advanced disease and chronic breathlessness (COPD n=13, lung cancer n=8, interstitial lung disease n=3, bronchiectasis n=1; 17 male; median (range) age 70 (47–86) years; median (range) Medical Research Council dyspnoea score 3 (2−5)) were interviewed. Individuals highlighted strong preferences for focused education, methods to increase self-motivation and engagement, interventions targeting breathing and physical function, software capability to personalise the content of SELF-BREATHE to make it more meaningful to the user, and aesthetically designed content using various communication methods including written, video and audio content. Furthermore, they identified the need to address motivation as a key potential determinant of the success of SELF-BREATHE. Conclusion Our findings provide an essential foundation for future digital intervention development (SELF-BREATHE) and scaled research.
Keywords	Medicine ; R
Subject code	360
Language	English
Publishing date	2022-07-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Efficacy of Anamorelin, a Novel Non-Peptide Ghrelin Analogue, in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Cachexia—Review and Expert Opinion

David C. Currow / Matthew Maddocks / David Cella / Maurizio Muscaritoli

International Journal of Molecular Sciences, Vol 19, Iss 11, p

2018 Volume 3471

Abstract: Cancer cachexia is a multilayered syndrome consisting of the interaction between tumor cells and the host, at times modulated by the pharmacologic treatments used for tumor control. Key cellular and soluble mediators, activated because of this ... ...

Abstract	Cancer cachexia is a multilayered syndrome consisting of the interaction between tumor cells and the host, at times modulated by the pharmacologic treatments used for tumor control. Key cellular and soluble mediators, activated because of this interaction, induce metabolic and nutritional alterations. This results in mass and functional changes systemically, and can lead to increased morbidity and reduced length and quality of life. For most solid malignancies, a cure remains an unrealistic goal, and targeting the key mediators is ineffective because of their heterogeneity/redundancy. The most beneficial approach is to target underlying systemic mechanisms, an approach where the novel non-peptide ghrelin analogue anamorelin has the advantage of stimulating appetite and possibly food intake, as well as promoting anabolism and significant muscle mass gain. In the ROMANA studies, compared with placebo, anamorelin significantly increased lean body mass in non-small cell lung cancer (NSCLC) patients. Body composition analysis suggested that anamorelin is an active anabolic agent in patients with NSCLC, without the side effects of other anabolic drugs. Anamorelin also induced a significant and meaningful improvement of anorexia/cachexia symptoms. The ROMANA trials have provided unprecedented knowledge, highlighting the therapeutic effects of anamorelin as an initial, but significant, step toward directly managing cancer cachexia.
Keywords	ghrelin ; anamorelin ; ROMANA 1 ; ROMANA 2 ; anorexia ; non-small cell lung cancer ; Biology (General) ; QH301-705.5 ; Chemistry ; QD1-999
Subject code	610
Language	English
Publishing date	2018-11-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Adaptation and multicentre validation of a patient-centred outcome scale for people severely ill with COVID (IPOS-COV)

Mevhibe B. Hocaoglu / Fliss E. M. Murtagh / Catherine Walshe / Rachel L. Chambers / Matthew Maddocks / Katherine E. Sleeman / Adejoke O. Oluyase / Lesley Dunleavy / Andy Bradshaw / Sabrina Bajwah / Lorna K. Fraser / Nancy Preston / Irene J. Higginson / the CovPall study team

Health and Quality of Life Outcomes, Vol 21, Iss 1, Pp 1-

2023 Volume 12

Abstract: Abstract Background Patient-centred measures to capture symptoms and concerns have rarely been reported in severe COVID. We adapted and tested the measurement properties of the proxy version of the Integrated Palliative care Outcome Scale–IPOS-COV for ... ...

Abstract	Abstract Background Patient-centred measures to capture symptoms and concerns have rarely been reported in severe COVID. We adapted and tested the measurement properties of the proxy version of the Integrated Palliative care Outcome Scale–IPOS-COV for severe COVID using psychometric approach. Methods We consulted experts and followed consensus-based standards for the selection of health status measurement instruments and United States Food and Drug Administration guidance for adaptation and analysis. Exploratory Factor Analysis and clinical perspective informed subscales. We tested the internal consistency reliability, calculated item total correlations, examined re-test reliability in stable patients, and also evaluated inter-rater reproducibility. We examined convergent and divergent validity of IPOS-COV with the Australia-modified Karnofsky Performance Scale and evaluated known-groups validity. Ability to detect change was examined. Results In the adaptation phase, 6 new items were added, 7 items were removed from the original measure. The recall period was revised to be the last 12–24 h to capture fast deterioration in COVID. General format and response options of the original Integrated Palliative care Outcome Scale were preserved. Data from 572 patients with COVID from across England and Wales seen by palliative care services were included. Four subscales were supported by the 4-factor solution explaining 53.5% of total variance. Breathlessness-Agitation and Gastro-intestinal subscales demonstrated good reliability with high to moderate (a = 0.70 and a = 0.67) internal consistency, and item–total correlations (0.62–0.21). All except the Flu subscale discriminated well between patients with differing disease severity. Inter-rater reliability was fair with ICC of 0.40 (0.3–0.5, 95% CI, n = 324). Correlations between the subscales and AKPS as predicted were weak (r = 0.13–0.26) but significant (p < 0.01). Breathlessness-Agitation and Drowsiness-Delirium subscales demonstrated good divergent validity. ...
Keywords	Patient-centred outcomes ; Severe COVID ; Symptoms ; Concerns ; Symptom severity ; Integrated Palliative care Outcome Scale ; Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	150
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Phase II, double blind, placebo controlled, multi-site study to evaluate the safety, feasibility and desirability of conducting a phase III study of anamorelin for anorexia in people with small cell lung cancer

Mariana S Sousa / Peter Martin / Miriam J Johnson / Michael Lind / Matthew Maddocks / Alex Bullock / Meera Agar / Sungwon Chang / Slavica Kochovska / Irina Kinchin / Deidre Morgan / Belinda Fazekas / Valentina Razmovski-Naumovski / Jessica T Lee / Malinda Itchins / Victoria Bray / David C Currow

PLoS ONE, Vol 18, Iss 5, p e

A study protocol (LUANA trial).

2023 Volume 0285850

Abstract: Anorexia is experienced by most people with lung cancer during the course of their disease and treatment. Anorexia reduces response to chemotherapy and the ability of patients to cope with, and complete their treatment leading to greater morbidity, ... ...

Abstract	Anorexia is experienced by most people with lung cancer during the course of their disease and treatment. Anorexia reduces response to chemotherapy and the ability of patients to cope with, and complete their treatment leading to greater morbidity, poorer prognosis and outcomes. Despite the significant importance of cancer-related anorexia, current therapies are limited, have marginal benefits and unwarranted side effects. In this multi-site, randomised, double blind, placebo controlled, phase II trial, participants will be randomly assigned (1:1) to receive once-daily oral dosing of 100mg of anamorelin HCl or matched placebo for 12 weeks. Participants can then opt into an extension phase to receive blinded intervention for another 12 weeks (weeks 13-24) at the same dose and frequency. Adults (≥18 years) with small cell lung cancer (SCLC); newly diagnosed with planned systemic therapy OR with first recurrence of disease following a documented disease-free interval ≥6 months, AND with anorexia (i.e., ≤ 37 points on the 12-item Functional Assessment of Anorexia Cachexia Treatment (FAACT A/CS) scale) will be invited to participate. Primary outcomes are safety, desirability and feasibility outcomes related to participant recruitment, adherence to interventions, and completion of study tools to inform the design of a robust Phase III effectiveness trial. Secondary outcomes are the effects of study interventions on body weight and composition, functional status, nutritional intake, biochemistry, fatigue, harms, survival and quality of life. Primary and secondary efficacy analysis will be conducted at 12 weeks. Additional exploratory efficacy and safety analyses will also be conducted at 24 weeks to collect data over longer treatment duration. The feasibility of economic evaluations in Phase III trial will be assessed, including the indicative costs and benefits of anamorelin for SCLC to the healthcare system and society, the choice of methods for data collection and the future evaluation design. Trial registration. ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: People with HIV and healthcare workers views on screening for cognitive impairment in people with HIV: A qualitative study.

Alford, Kate / Sidat, Shiraaz / Bristowe, Katherine / St Clair-Sullivan, Natalie / Parteger, Gary / Matthew, Maddocks / Yi, Deokhee / Harding, Richard / Levett, Tom / Bremner, Stephen / Vera, Jaime H

HIV medicine

2023 Volume 24, Issue 12, Page(s) 1244–1252

Abstract: Objectives: People with HIV are an ageing population with an increased risk of cognitive impairment. Although cognitive impairment is dependent upon assessment, the acceptability of screening for cognitive impairment is unclear. This study aimed to ... ...

Abstract	Objectives: People with HIV are an ageing population with an increased risk of cognitive impairment. Although cognitive impairment is dependent upon assessment, the acceptability of screening for cognitive impairment is unclear. This study aimed to explore the views of people with HIV and healthcare workers regarding routine screening for cognitive impairment. Methods: In-depth individual qualitative interviews were conducted with purposively sampled people with HIV and focus groups of healthcare workers from a UK HIV service. Verbatim pseudonymized transcripts were analysed using reflexive thematic analysis supported by NVivo. Results: Twenty people with HIV were interviewed and 12 healthcare workers participated in three focus groups. People with HIV were concerned about developing cognitive issues and were receptive to routine screening. Screening was seen as relevant and an important part of managing health in older age. Healthcare workers expressed concerns regarding the capacity of HIV services to implement routine screening and questioned the validity of screening measures used. People with HIV felt that screening and subsequent detection of cognitive impairment, if present, may help them to prepare for future issues and promote active management strategies and care pathways that would support cognitive health. People with HIV felt that screening should be brief and delivered by the HIV service and that they should be given a choice of administration method. Indications of cognitive impairment detected by a brief screening assessment should be discussed face to face and followed up with a comprehensive assessment. Conclusions: People with HIV are concerned about cognitive impairment and would welcome regular screening for this as part of the holistic care provided by the HIV team. Both people with HIV and healthcare workers would like more information on cognitive impairment, its screening and ways to support cognitive health.
MeSH term(s)	Humans ; HIV Infections/complications ; Health Personnel ; Cognitive Dysfunction/diagnosis ; Cognitive Dysfunction/etiology ; Qualitative Research
Language	English
Publishing date	2023-11-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2001932-4
ISSN	1468-1293 ; 1464-2662
ISSN (online)	1468-1293
ISSN	1464-2662
DOI	10.1111/hiv.13582
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Socioeconomic position and use of hospital-based care towards the end of life

Joanna M Davies, MSc / Matthew Maddocks, PhD / Kia-Chong Chua, PhD / Panayotes Demakakos, PhD / Katherine E Sleeman, ProfPhD / Fliss E M Murtagh, ProfPhD

The Lancet Public Health, Vol 6, Iss 3, Pp e155-e

a mediation analysis using the English Longitudinal Study of Ageing

2021 Volume 163

Abstract: Summary: Background: Many patients prefer to avoid hospital-based care towards the end of life, yet hospitalisation is common and more likely for people with low socioeconomic position. The reasons underlying this socioeconomic inequality are not well ... ...

Abstract	Summary: Background: Many patients prefer to avoid hospital-based care towards the end of life, yet hospitalisation is common and more likely for people with low socioeconomic position. The reasons underlying this socioeconomic inequality are not well understood. This study investigated health, service access, and social support as potential mediating pathways between socioeconomic position and receipt of hospital-based care towards the end of life. Methods: For this observational cohort study, we included deceased participants from the nationally representative English Longitudinal Study of Ageing of people aged 50 years or older in England. We used a multiple mediation model with age-adjusted and gender-adjusted probit regression to estimate the direct effect of socioeconomic position (measured by wealth and education) on death in hospital and three or more hospital admissions in the last 2 years of life, and the indirect effects of socioeconomic position via three mediators: health and function, access to health-care services, and social support. Findings: 737 participants were included (314 [42·6%] female, 423 [57·4%] male), with a median age at death of 78 years (IQR 71–85). For death in hospital, higher wealth had a direct negative effect (probit coefficient −0·16, 95% CI −0·25 to −0·06), which was not mediated by any of the pathways tested. For frequent hospital admissions, health and function mediated the effect of wealth (−0·04, −0·08 to −0·01), accounting for 34·6% of the total negative effect of higher wealth (−0·13, −0·23 to −0·02). Higher wealth was associated with better health and function (0·25, 0·18 to 0·33). Education was associated with the outcomes only indirectly via wealth. Interpretation: Our findings suggest that worse health and function could partly explain why people with lower wealth have more hospital admissions, highlighting the importance of socioeconomically driven health differences in explaining patterns of hospital use towards the end of life. The findings should raise ...
Keywords	Public aspects of medicine ; RA1-1270
Subject code	360
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Minimal versus specialist equipment in the delivery of pulmonary rehabilitation

Matthew Maddocks / Francesca Fiorentino / Suhani Patel / Jessica A Walsh / William Man / Rebecca Wilson / Ruth E Barker / Claire M Nolan / Oliver Polgar

BMJ Open, Vol 11, Iss

protocol for a non-inferiority randomised controlled trial

2021 Volume 10

Keywords	Medicine ; R
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Pharmacological and nonpharmacological interventions to improve symptom control, functional exercise capacity and quality of life in interstitial lung disease

Sabrina Bajwah / Jill Colquitt / Emma Loveman / Claudia Bausewein / Howard Almond / Adejoke Oluyase / Mendy Dzingina / Matthew Maddocks / Irene J. Higginson / Athol Wells

ERJ Open Research, Vol 7, Iss

an evidence synthesis

2021 Volume 1

Abstract: We assessed efficacy and effectiveness of pharmacological and nonpharmacological interventions in improving symptom control, functional exercise capacity and quality of life (QoL) in people living with fibrotic interstitial lung disease (ILD). We ... ...

Abstract	We assessed efficacy and effectiveness of pharmacological and nonpharmacological interventions in improving symptom control, functional exercise capacity and quality of life (QoL) in people living with fibrotic interstitial lung disease (ILD). We summarised evidence from three previous reviews (to June 2014) and conducted an updated search of nine databases and grey literature (2011–2019) (registration: CRD42017065933) for prospective studies of interventions aimed to alleviate symptoms, improve QoL or functional exercise capacity in fibrotic ILD. Data were synthesised through narrative synthesis or meta-analysed as appropriate. Forty-seven studies with 2527 participants were included. From 22 pharmacological studies of 11 different interventions (n=1683), the most tested interventions were bosentan and sildenafil. From 25 nonpharmacological studies, the most tested intervention was for pulmonary rehabilitation/exercise training (PR) (22 studies, n=748). There was an improvement in 6-min walk distance immediately following PR (six studies; n=200, mean difference (MD) (95% CI) 39.9 m (18.2 to 61.5)), but not longer term (3 or 6 months, four studies; n=147, MD 5.3 m (−12.9 to 23.4). Multiple, varied outcome measures were used (e.g. 37 studies assessing dyspnoea used 10 different scales with a lack of reporting of rate of deterioration in outcomes). Evidence gap mapping highlighted the most and least researched symptoms, as dyspnoea and cough, respectively. This evidence synthesis highlights overwhelmingly that the most researched symptom is dyspnoea and the strongest evidence base is for short-term PR. The least researched symptom was cough. Research going forward must focus on prioritising and standardising meaningful outcomes and focussing interventions on neglected symptoms.
Keywords	Medicine ; R
Subject code	796
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	European Respiratory Society
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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