Joseph W. Lanario

Background: Biologic treatments for severe asthma can be life-changing, yet reponses vary in degree and timing. Aim: To explore patient-reported variation in health-related quality of life (HRQoL) response to biologic treatment. Methods: Survey data were collected from patients who were on a biologic treatment, across 17 countries through the Severe Heterogeneous Asthma Research Collaboration, Patient-centred (SHARP) network. Predictors of SAQ-global (0-100) at 6-18 months were examined using a two-step hierarchical multiple linear regression. After adjusting for demographics, biologic type and time on biologic, we examined number of side effects at initiation and time to first change noticed. Results: A total of 904 patients participated. Those with complete data were analysed (N = 780; 62% female; mean age 55 [SD 14] years; mean SAQ-global 75 [SD 18]). Demographics, biologic type, and time on treatment explained modest variance in HRQoL improvement (R² = 0.09, P 4months No change -15.23 (-21.99, -8.48)** 3-4 months 3.43 (-1.14, 8.01 2–3 months 4.62 (0.39, 8.85)* 1-2 months 4.94 (0.61, 9.27)* End of first month 8.43 (4.08, 12.78)** End of first week 10.85 (5.99, 15.70)** Adjusted for age, sex, country, biologic type and treatment duration; R²=0.26 (adj 0.23); n=780. *p<0.05, **p<0.001

Biologic therapies have transformed care for people with severe asthma, yet treatment response has traditionally been assessed using clinician-derived measures, including lung function, exacerbation rates, and oral corticosteroid use. These metrics, while clinically important, frequently fail to capture what matters most to patients: their ability to participate in daily life, maintain relationships, and sustain work and social roles. The publication of the Core Outcome Measures Set for Severe Asthma (COMSA) and the subsequent CompOsite iNdexes For Response in asthMa (CONFiRM) composite score mark a shift towards patient-centred measurement of treatment response in severe asthma. Rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) travelled this path decades earlier. Both conditions adopted composite scoring tools, such as the Disease Activity Score-28 (DAS28) and the Mayo Score, that incorporated Patient-Reported Outcome Measures (PROMs) alongside objective markers. Initiatives like Outcome Measures in Rheumatology (OMERACT) in RA and Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) in IBD demonstrate that sustained, multidisciplinary collaboration between patients, clinicians, regulators, and industry can successfully embed PROMs into clinical trials and routine care. We argue that timely integration of health-related quality of life measures into clinical trials and practice requires electronic data collection, regulatory endorsement of PROMs as co-primary endpoints, and genuine patient partnership in research, beyond tokenism. By learning from parallel specialties, the asthma community can build a model of care that reflects what truly matters to those living with the disease.

Background: Fatigue, breathlessness and cough are prevalent symptoms of Interstitial Lung Disease (ILD) adversely impacting quality-of-life and contributing to psychological distress. The Fatigue and Breathlessness (FAB) programme facilitates supported self-management for people living with life-limiting conditions such as cancer. We explore its utility when adapted for people living with ILD. Methods: The 4-week ILD-FAB programme offers each group of up to 6 participants weekly two-hour sessions led by an ILD-specialist Physiotherapist and Clinical Nurse Specialist (CNS). Primary focus is on strategies to manage breathlessness, fatigue and wellbeing. Further, a 1:1 session with the ILD-CNS enables participants to set personalised goals and explore individual health beliefs/behaviours using a Cognitive Behavioural Therapy (CBT) assessment framework. The self-reporting Chronic Respiratory Questionnaire (CRQ-SR) evaluates breathlessness, fatigue, emotional function and mastery at baseline and after 4 weeks. We facilitated eleven groups between March 2023 and December 2024. Results: Forty-nine participants (26 male; median age 76 years [IQR=14]) were diagnosed with Idiopathic Pulmonary Fibrosis/IPF (n=21), Progressive Pulmonary Fibrosis/PPF (n=17) or non-progressive ILD (n=11) of various aetiologies. Lung function indicated a range of disease severity (FVC % predicted median: 70% [IQR=34]) Thirty-seven (76%) participants attended all four sessions, 6 (12%) attended three sessions, 2 (4%) attended two sessions and 4 (8%) attended one session. Thirty-seven patients, all who attended at least 3 sessions, completed the CRQ-SR at baseline and Week 4. Fifty-nine percent of respondents (n=22) demonstrated clinically significant improvements in dyspnoea scores, 51% (n=19) in emotional functioning scores and 49% (n=18) in fatigue and mastery scores. Thirty-five respondents (95%) demonstrated a clinically significant improvement in at least one domain. All participants (100%) would recommend this programme to others. Conclusion: These data demonstrate feasibility, acceptability and clinical effectiveness of an ILD-specific FAB programme. Further research will explore a range of outcome measures longitudinally in a larger cohort. Key Messages: What is already known on this topic - The FAB programme is delivered in hospices and NHS trusts UK-wide to improve confidence in fatigue and breathlessness management and reduce anxiety for people living with life-limiting illnesses such as cancer. Formal evaluations are positive but limited by small sample sizes and the use of non-validated outcome measures. What this study adds - Our FAB programme, adapted for people with ILD, is feasible, acceptable and clinically effective. How this study might affect research, practice or policy – The FAB programme offers one multimodal approach to improving self-management in people with ILD. Further research in a larger, more heterogeneous patient population will optimise outcome measures, broaden acceptability and determine cost-effectiveness.

Background: Biologic therapy in asthma can be life-changing and affect health-related quality of life, but symptoms are rarely used in the assessment of response. Aim: To examine the change in health-related quality of life and asthma control between starting a biologic and assessment of biologic response, assessing whether this change can provide early prediction of eventual clinical response at 12 months. Methods: A service evaluation of severe asthmatics initiating a biologic at the Royal Devon NHS trust between 2019 and 22. Health-Related Quality of Life (Severe Asthma Questionnaire) and asthma control (Asthma Control Questionnaire-6) was captured at baseline, 8 weeks, 16 weeks and 12 months. Patients were classified as responder or non-responder using NICE Criteria for biologic response. Independent samples t-tests were used to determine statistical difference in change from baseline patient reported outcome measure scores between responder and non-responders. Results: One hundred and eight initiations (103 patients) of biologic therapy were included. At 8 weeks and 16 weeks, responders had greater improvement in Severe Asthma Questionnaire & Severe Asthma Questionnaire Global compared to non-responders (p< 0.05). Improvement in Asthma Control Questionnaire only achieved significance between all-responders and non-responders at 16 weeks (p< 0.05). Conclusion: This study provides evidence of the early and sustained improvement in health-related quality of life and symptoms after starting biologic therapy. The findings support the use of the Severe Asthma Questionnaire and the Asthma Control Questionnaire as per the Core Outcome Measures Sets for Severe Asthma (COMSA). We have shown that health-related quality of life and asthma control can assist earlier assessment of response and non-response to biologics.

Objective: Patient reported experience measures (PREMs) are a key component of healthcare accountability frameworks, health policy, integrated care board (ICB) commissioning and integrated care partnerships (ICPs) generating data which are crucial markers of patient care quality. The Rheumatoid Arthritis Patient Reported Experience Measure (RA-PREM) incorporates the eight core elements of NHS Patient Experience Framework and is validated in a range of rheumatic conditions. Our objective is to determine the acceptability and feasibility of the RA-PREM for an ILD population. Design: A mixed-methods patient-centred approach incorporating an interdisciplinary research steering group with patient-partners. Patient surveys evaluated the language and meaning of the RA-PREM eight domains, twenty-four statements and response categories. A patient focus group examined contentious statements. A consensus group of expert patient-partners agreed statements for the modified RA-PREM. Focus group participants reviewed the modified instrument (ILD-PREM) for acceptability and face/content validity. Setting: A single NHSE-commissioned, regional ILD service/UK. Results: Thirteen patients (10 male) diagnosed with ILD participated in focus group discussions. Critical discussion of the RA-PREM resulted in nuanced modifications of four statements of three domains. Five patients (3 male) and three healthcare researchers attained consensus on the face/content validity of statements. Seventy-three patients completed the ILD-PREM following outpatient contact. Conclusion: The ILD-PREM retains twenty-four statements representing the eight domains of the RA-PREM. It meets face/content validity criteria and is acceptable to an ILD population. Longitudinal validation of the ILD-PREM across ILD services including further testing in global minority groups will establish criterion and construct validity and objective measures of reliability. Key Messages: What is already known on this topic Patient experience metrics are a key component of healthcare quality frameworks. Better patient experience is associated with better quality of care, higher treatment adherence and improved patient outcomes. What this study adds The RA-PREM has been adapted for use within ILD, using patient-centred methods. The ILD-PREM retains twenty-four statements capturing level of agreement which map to the eight indicators of the NHS Patient Experience Framework. The ILD-PREM has face/content validity and clinical utility for an ILD population. How this study might affect research, practice, or policy This is the first disease-specific PREM for ILD enabling data collection for service evaluation and improvement. It is judicious to modify validated measures to obviate the need for resource intensive development of a new instruments where possible.

Background: Biologic treatments are increasingly used in severe asthma. Aim: To compare clinical characteristics in patients receiving biologic treatments for ≥1 month compared to those not prescribed a biologic or receiving a biologic for <1 month. Method: Real-word data from adults in the Severe Heterogeneous Asthma Research Collaboration Patient-centred (SHARP) registry included the Severe Asthma Questionnaire (SAQ), SAQ-global, Asthma Control Questionnaire-6 (ACQ) collected via PatientCoach app and clinical data. Patients established (receiving treatment ≥1 month) or not established (not prescribed or on treatment <1 month) on biologics were compared using t-tests. Results: Data were available for 221 participants. 103 not established and 118 established (mean 33 months) on biologics. Questionnaire scores were significantly better in patients established on biologics. Exacerbations and daily ICS use were also significantly lower in this group (Table 1). Conclusion: These data show that biologic treatments significantly improve asthma HRQoL and control, while reducing exacerbations and reliance on ICS. Table 1. Means (n) and SDs for questionnaires and clinical data for patients established or not on biologics. erj;64/suppl_68/PA2168/TB1 T1 TB1 Not established Established SAQ (1-7) 4.12 (63) 1.76 5.38* (75) 1.41 SAQ-global (0-100) 49.32 (63) 23.89 69.76* (75) 19.09 ACQ (6-0) 2.50 (81) 1.39 1.41* (96) 1.18 BMI 30.75 (103) 7.81 32.53 (117) 33.03 FEV1 2.50 (89) 0.76 2.67 (108) 0.95 FEV1%pred 83.43 (89) 20.38 83.34 (110) 21.53 Exacerbations 2.59 (103) 2.47 1.67* (118) 2.26 Hospital admissions 0.35 (103) 0.74 0.26 (116) 0.74 Daily ICS (BDP equivalent) 878.05 (97) 1015.59 483.77* (110) 773.29 *p<0.01

Background: Depression is more common in severe asthma than in the general population and is associated with poorer outcomes. Aim: To describe HRQoL and asthma control in patients with and without a recorded diagnosis of depression by their GP or other clinician and indicated by the Patient Health Questionnaire-2 (PHQ-2). Method: Real-word data from adults in the Severe Heterogeneous Asthma Research Collaboration Patient-centered (SHARP) registry included the Severe Asthma Questionnaire (SAQ), SAQ-global and Asthma Control Questionnaire-6 (ACQ) collected via PatientCoach app. PHQ-2 scores of ≥3 indicate depression. Results: 216 participants provided data. All questionnaire scores were significantly (p <0.01) worse for those with a clinical record of depression and a PHQ2 ≥3 compared to those with no clinical record of depression and a PHQ-2 ≤2. SAQ and SAQ-global but not ACQ scores were significantly (p <0.05) worse for patients with no clinical record of depression and a PHQ-2 ≥3 compared to those with a clinical record of depression and PHQ-2 ≤2 (Table 1). Age and gender did not differ significantly between groups. Conclusion: These data highlight the importance of patients own evaluations of depression, and its impact on HRQoL. Table 1. Questionnaire scores (n) and SD for clinical record and/or patient indicated depression. erj;64/suppl_68/PA3231/TB1 T1 TB1 No clinical record of depression Clinical record of depression PHQ2 ≤2 PHQ2 ≥3 PHQ2 ≤2 PHQ2 ≥3 SAQ (1-7) 5.77 (131) 1.74 3.61 (37) 1.51 4.99 (13) 1.57 2.84 (14) 1.89 SAQ-global (0-100) 72.99 (131) 19.04 45.14 (37) 21.29 60.38 (13) 21.93 39.29 (14) 21.02 ACQ (6-0) 1.21 (150) 1.10 2.57 (37) 1.46 1.95 (14) 1.34 3.22 (15) 1.33

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.