Evidence for similarity in symptoms and mechanism: The extra‐pulmonary symptoms of severe asthma and the polysymptomatic presentation of fibromyalgia

Background Asthma is a disease of the lung and a systemic disease. Functional disorders are associated with multiple systemic abnormalities that have been explained by complexity models. The aim was to test the similarity in type and aetiology between the extra‐pulmonary symptoms of severe asthma and the symptoms of fibromyalgia. Methods One Hundred patients recruited from a specialist severe asthma clinic and 1751 people reporting different functional disorder diagnoses recruited via the internet completed the same 60‐item questionnaire. Symptom patterns were compared between groups using a new measure, the symptom pattern similarity index where 0 = no relationship, 1 = identical patterns between groups. Results Severe asthma patients report numerous extra‐pulmonary symptoms. The similarity index between the symptom pattern of the asthma patients with other groups was irritable bowel syndrome = 0.54, chronic fatigue syndrome = 0.69, and fibromyalgia = 0.75. The index between fibromyalgia and asthma patients with the most and least frequent extra‐pulmonary symptoms was 0.81 and 0.55 respectively. Conclusions Patients with severe asthma have numerous extra‐pulmonary symptoms similar in type and pattern to the symptoms of fibromyalgia. The similarity of the symptom pattern between asthma and fibromyalgia increases as the number of extra‐pulmonary symptoms increases as predicted by network theory and previously shown to be the case with other functional disorders. These findings support the hypothesis that functional disorders and extra‐pulmonary asthma symptoms have a common complexity or network aetiology. Evidence based behavioural interventions for fibromyalgia may be helpful for patients with severe asthma reporting extra‐pulmonary symptoms

P196 A new questionnaire to measure quality of life in severe asthma (saq): preliminary validation

Introduction and Objectives Existing HRQoL scales have poor content validity for severe asthma as they fail to measure the qualitatively different burdens experienced by the severe asthma population compared to those with mild or moderate asthma, in particular, the side effects of oral corticosteroids (OCS). A new severe asthma quality of life questionnaire (SAQ) has been designed using extensive patient input in qualitative studies as per FDA guidelines. The questionnaire has 16 questions rated on a 1–7 Likert scale and a 100 point global quality of life scale (GQoL) similar to the EQ-5Ds 100 point visual analogue scale (VAS) (SAQ.org.uk). Methods Consecutive consenting patients attending the severe asthma clinic in Plymouth with severe asthma were invited to participate in a cross sectional survey. Patients completed four questionnaires the SAQ, mini Asthma Quality of Life Questionnaire (miniAQLQ), Asthma Control Test (ACT) and the EQ-5D. Prednisolone dose and frequency of severe exacerbations were obtained from clinic records. Results 102 participants (64 female, mean age=51 years range 18–79 years), of whom 38 were on maintenance OCS consented to take part, mean FEV1% of 69%. Correlations between the four questionnaires were all above 0.65. Correlations with frequency of severe exacerbations were SAQ 0.31, miniAQLQ 0.31, ACT 0.34. The SAQ’s GQoL correlated with the EQ-5D’s VAS at 0.73. The SAQ was significantly better than the miniAQLQ at predicting the quality of life of patients taking ≥10 mg OCS a day (p<0.05 vs p=0.88). These questionnaires had parallel Results for doses up to 10 mg but above that only SAQ provided differentiation between patients

Supporting self-management for patients with Interstitial Lung Diseases:Utility and acceptability of digital devices

INTRODUCTION: Patients diagnosed with Interstitial Lung Diseases (ILD) use devices to self-monitor their health and well-being. Little is known about the range of devices, selection, frequency and terms of use and overall utility. We sought to quantify patients' usage and experiences with home digital devices, and further evaluate their perceived utility and barriers to adaptation.METHODS: A team of expert clinicians and patient partners interested in self-management approaches designed a 48-question cross-sectional electronic survey; specifically targeted at individuals diagnosed with ILD. The survey was critically appraised by the interdisciplinary self-management group at Royal Devon University Hospitals NHS Foundation Trust during a 6-month validation process. The survey was open for participation between September 2021 and December 2022, and responses were collected anonymously. Data were analysed descriptively for quantitative aspects and through thematic analysis for qualitative input.RESULTS: 104 patients accessed the survey and 89/104 (86%) reported a diagnosis of lung fibrosis, including 46/89 (52%) idiopathic pulmonary fibrosis (IPF) with 57/89 (64%) of participants diagnosed &gt;3 years and 59/89 (66%) female. 52/65(80%) were in the UK; 33/65 (51%) reported severe breathlessness medical research council MRC grade 3-4 and 32/65 (49%) disclosed co-morbid arthritis or joint problems. Of these, 18/83 (22%) used a hand- held spirometer, with only 6/17 (35%) advised on how to interpret the readings. Pulse oximetry devices were the most frequently used device by 35/71 (49%) and 20/64 (31%) measured their saturations more than once daily. 29/63 (46%) of respondents reported home-monitoring brought reassurance; of these, for 25/63 (40%) a feeling of control. 10/57 (18%) felt it had a negative effect, citing fluctuating readings as causing stress and 'paranoia'. The most likely help-seeking triggers were worsening breathlessness 53/65 (82%) and low oxygen saturation 43/65 (66%). Nurse specialists were the most frequent source of help 24/63 (38%). Conclusion: Patients can learn appropriate technical skills, yet perceptions of home-monitoring are variable; targeted assessment and tailored support is likely to be beneficial.</p

How patient participation was used to develop a questionnaire that is fit for purpose for assessing quality of life in severe asthma.

BACKGROUND: Previous research shows that existing asthma quality of life questionnaires fail to measure the burden of oral corticosteroids that can be used to treat severe asthma, and are therefore not fit for purpose for severe asthma according to the USA's Federal Drug Authority's (FDA) criteria for content validity. Patient input and documentation of that input is key to achieving content validity according to FDA guidelines. This paper describes the process of constructing a new questionnaire to measure the burden of asthma symptoms and burden of treatment in severe asthma, using criteria specified by the FDA. METHODS: A draft severe asthma questionnaire (SAQ) was constructed using qualitative input from severe asthma patients who took part in an earlier study. The aim of this study was to improve that draft questionnaire using a further group of patients. In four iterative focus groups, 16 people with severe asthma completed the draft questionnaire, discussed the wording and structure and suggested changes that were incorporated into the final version. RESULTS: The original intention to ask patients to identify whether problems were caused by asthma symptoms or side effects of medication was abandoned as the attribution of cause was found to be difficult and inconsistent. The recall period of 2 weeks was acceptable but fails to reflect the patients' desire to express the variability of severe asthma. Patients suggested improvements to the wording of the draft questionnaire, including splitting some items in two, combining two items in one, and changes to some of the words in individual items and the response scale. CONCLUSIONS: The final version of the questionnaire was substantially different from one constructed using only qualitative reports from patients about the quality of life deficits of severe asthma. Patients make a valuable contribution to the questionnaire if they are asked to comment and improve an initial draft and where patients are treated as partners in the process of questionnaire construction, rather than only as a source of information to experts who construct the questionnaire

Body reprogramming for fibromyalgia and central sensitivity syndrome: A preliminary evaluation

Objectives: Central sensitivity syndrome disorders such as fibromyalgia, provoke continued debate, highlighting diagnostic and therapeutic uncertainty. The Hyland model provides a way of understanding and treating the medically unexplained symptoms of central sensitivity syndromes using complexity theory and principles of adaption in network systems. The body reprogramming is a multi-modal intervention based on the Hyland model designed for patients living with medically unexplained symptoms. This preliminary, naturalistic and single-arm service evaluation set out to evaluate outcome after attending a body reprogramming course in patients living with fibromyalgia or central sensitivity syndrome. Methods: Patients diagnosed with fibromyalgia or central sensitivity syndrome were recruited. The body reprogramming courses consisting of eight sessions, each 2.5 h in length, were run at two study sites in England. Data were collected at baseline, post course and 3-months post course using questionnaires assessing symptomatology (FIQR/SIQR), Depression (PHQ9), Anxiety (GAD7) and quality of life (GQoL). Repeated measures t -tests were used, and all comparisons were conducted on an intention to treat basis. Results: In total, 198 patients with a mean age of 47.73 years were enrolled on the body reprogramming courses. Statistically and clinically significant improvement were observed in the FIQR from baseline to post course (mean change: 11.28) and baseline to follow-up (mean change: 15.09). PHQ9 scores also improved significantly from baseline to post course (mean reduction 3.72) and baseline to follow-up (mean reduction 5.59). Conclusions: Our study provides first evidence that the body reprogramming intervention is an effective approach for patients living with fibromyalgia or central sensitivity syndromes on a variety of clinical measures. Besides these promising results, important limitations of the study are discussed, and larger randomized controlled trials are clearly warranted

“Life-changing”: the experience of super-responders to biologics in severe asthma

Abstract Background There is limited information on the patient’s perspective of how biologic treatments impact their lives. We conducted a qualitative study to explore the patient’s experience of being considered a super-responder from a quality of life perspective. Methods Patients with severe asthma identified as super-responders were invited to semi-structured interviews conducted online. Participants could bring a family member/friend to the interview. The interviews explored experiences of biologic treatment, were transcribed and underwent thematic analysis. Results Twenty-five participants took part in this study. Themes emerged on the impact of biologic treatment for participants and for their friends/family: (i) Words used to describe their often life-changing experiences and (ii) the positive changes noted. Biologic treatment stopped the disruption of family life and social life caused by exacerbations. Improvements in mental health were also noted. Marked individual variations in the way it affected their lives were noted. Most participants noticed improvements 2–3 months after starting their biologic, but some noticed improvement within a few days and others after 6 months. Conclusions Super-responders reported profound but heterogeneous improvements following biologic treatment beyond asthma symptoms and exacerbations including important benefits to social and family life. Improvements may be underestimated as social and family benefits are not reliably measured in current studies with implications for health economic evaluations. Not all patients are super-responders, and excellent responses may be lost in group mean data in trials. Individual time course and response patterns need further elucidation to identify who will respond best to biologics

Validation of subscales of the Severe Asthma Questionnaire (SAQ) using exploratory factor analysis (EFA)

Background: The Severe Asthma Questionnaire (SAQ) is a health related quality of life (HRQoL) questionnaire validated for use in severe asthma. It is scored using the mean value of 16 items (SAQ score) in addition to a single item global rating of HRQoL (SAQ-global). The aim was to validate clinically relevant subscales using exploratory factor analysis (EFA). Methods: The SAQ was completed, along with measures of asthma control and EQ5D-5L by patients attending six UK severe asthma centres. Clinical data were included in the analysis. EFA using principal axis factoring and oblimin rotation was used to achieve simple structure of data. Results: 460 patients with severe asthma participated, 65% women, mean age 51 (16-83) years. A three factor solution achieved best fit and showed that the SAQ items formed three distinct but inter-correlated groups of items where items were grouped in a way that was consistent with item content. The three subscales were differentially associated with clinically relevant variables (lung function and mood). Males and females interpreted the question of night disturbance in different ways. Conclusions: This paper provides a template for best practice in the use of EFA when validating HRQoL subscales. The SAQ can be scored as three subscales with content reflecting three different constructs people with severe asthma use when making judgements about their lives. The subscale 'My Life' assesses the impact of severe asthma on different life activities, 'My Mind' assesses the perceived emotional impact and 'My Body' the impact of extra-pulmonary symptoms and side effects.This article is available to RD&E staff via NHS OpenAthens (subject to any publisher embargo). Click on the Publisher URL, and log in with NHS OpenAthens if prompted.Investigator led non-promotional grant from GlaxoSmithKline.published version, accepted versio

Patient perspectives on home-spirometry in interstitial lung disease: a qualitative co-designed study

Background Opportunities for home-monitoring are increasing exponentially. Home- spirometry is reproducible and reliable in interstitial lung disease (ILD), yet patients’ experiences are not reported. Given the morbidity and mortality associated with ILDs, maintaining health-related quality-of-life is vital. We report our findings from a codesigned, qualitative study capturing the perspectives and experiences of patients using home-spirometry in a UK regional ILD National Health Service England (NHSE) commissioned service.Methods Patients eligible for home-spirometry as routine clinical care, able to give consent and able to access a smart phone were invited to participate. In-depth, semistructured interviews were conducted at serial time points (baseline, 1, 3 and 6 months), recorded, transcribed and analysed thematically.Results We report on the experiences of 10 recruited patients (8 males; median age 66 years, range 50–82 years; 7 diagnosed with idiopathic pulmonary fibrosis, 3 other ILDs) who generally found spirometry convenient and easy to use, but their relationships with forced vital capacity results were complex. Main themes emerging were: (1) anticipated benefits—to identify change, trigger action and aid understanding of condition; (2) needs—clinical oversight and feedback, understanding of results, ownership, need for data and a need ‘to know’; (3) emotional impact—worry, reassurance, ambivalence/conflicting feelings, reminder of health issues, indifference; (4) ease of home-spirometry—simplicity, convenience and (5) difficulties with home-spirometry—technical issues, technique, physical effort.Conclusion Home-spirometry has many benefits, but in view of the potential risks to psychological well-being, must be considered on an individual basis. Informed consent and decision-making are essential and should be ongoing, acknowledging potential limitations as well as benefits. Healthcare support is vital

Digital devices ILD survey de-identified data set.

CSV files contains raw survey data questions as asked and participants responses available at 10.6084/m9.figshare.24569851 (CSV)</p