Finding Silver Linings in the Covid-19 Pandemic: A 2-Wave Study in the UK.

The Covid-19 pandemic has resulted in widespread anxiety, fear and depression, yet focussing only on these negative issues may obscure the opportunity to promote positivity and resilience. Traumatic events can often result in positive life changes (adversarial growth) though there is little evidence in the context of pandemics, and no previous studies in Covid-19 with the general public. The present research investigated whether adversarial growth was perceived in Covid-19 and whether this could account for variance in wellbeing, over and above effects of personality traits. Participants recruited from the UK public (N = 183) completed the Big Five Personality Inventory, the WHO-5 Wellbeing Scale and the Silver Lining Questionnaire (SLQ) measure of adversarial growth. Questionnaires were completed online, at two timepoints, nine months apart. At Time 1, wellbeing was negatively associated with trait Neuroticism and positively associated with Openness to experience. Both associations were positively mediated by SLQ score. At Time 2, SLQ score again mediated the effects of Openness on wellbeing, and also the influence of wellbeing at Time 1 on that at Time 2. Reported Silver Linings included strengthened personal relationships at Time 1, and improved ability to handle life events at Time 2. This suggests a shift from an appreciation of relationships to an awareness of personal development once life returned to some semblance of normality. Overall, results suggest that perceived adversarial growth supported wellbeing during the pandemic and highlight a focus for therapeutic intervention.

COVID-19 vaccination acceptance, safety and side-effects in European patients with severe asthma.

Background: Vaccination is vital for achieving population immunity to severe acute respiratory syndrome coronavirus 2, but vaccination hesitancy presents a threat to achieving widespread immunity. Vaccine acceptance in chronic potentially immunosuppressed patients is largely unclear, especially in patients with asthma. The aim of this study was to investigate the vaccination experience in people with severe asthma. Methods: Questionnaires about vaccination beliefs (including the Vaccination Attitudes Examination (VAX) scale, a measure of vaccination hesitancy-related beliefs), vaccination side-effects, asthma control and overall safety perceptions following coronavirus disease 2019 (COVID-19) vaccination were sent to patients with severe asthma in 12 European countries between May and June 2021. Results: 660 participants returned completed questionnaires (87.4% response rate). Of these, 88% stated that they had been, or intended to be, vaccinated, 9.5% were undecided/hesitant and 3% had refused vaccination. Patients who hesitated or refused vaccination had more negative beliefs towards vaccination. Most patients reported mild (48.2%) or no side-effects (43.8%). Patients reporting severe side-effects (5.7%) had more negative beliefs. Most patients (88.8%) reported no change in asthma symptoms after vaccination, while 2.4% reported an improvement, 5.3% a slight deterioration and 1.2% a considerable deterioration. Almost all vaccinated (98%) patients would recommend vaccination to other severe asthma patients. Conclusions: Uptake of vaccination in patients with severe asthma in Europe was high, with a small minority refusing vaccination. Beliefs predicted vaccination behaviour and side-effects. Vaccination had little impact on asthma control. Our findings in people with severe asthma support the broad message that COVID-19 vaccination is safe and well tolerated.

What bothers severe asthma patients most? A paired patient-clinician study across seven European countries.

Introduction: Severe asthma is a complex, multidimensional disease. Optimal treatment, adherence and outcomes require shared decision-making, rooted in mutual understanding between patient and clinician. This study used a novel, patient-centred approach to examine the most bothersome aspects of severe asthma to patients, as seen from both perspectives in asthma registries. Methods: Across seven countries, 126 patients with severe asthma completed an open-ended survey regarding most the bothersome aspect(s) of their asthma. Patients' responses were linked with their treating clinician who also completed a free-text survey about each patient's most bothersome aspect(s). Responses were coded using content analysis, and patient and clinician responses were compared. Finally, asthma registries that are part of the SHARP (Severe Heterogeneous Asthma Research collaboration, Patient-centred) Clinical Research Collaboration were examined to see the extent to which they reflected the most bothersome aspects reported by patients. Results: 88 codes and 10 themes were identified. Clinicians were more focused on direct physical symptoms and were less focused on "holistic" aspects such as the effort required to self-manage the disease. Clinicians accurately identified a most bothersome symptom for 29% of patients. Agreement was particularly low with younger patients and those using oral corticosteroids infrequently. In asthma registries, patient aspects were predominantly represented in questionnaires. Conclusions: Results demonstrated different perspectives and priorities between patients and clinicians, with clinicians more focused on physical aspects. These differences must be considered when treating individual patients, and within multidisciplinary treatment teams. The use of questionnaires that include multifaceted aspects of disease may result in improved asthma research.

Exploring the role of ride-hailing in trip chains.

Ride-hailing can potentially provide a variety of benefits to individuals who need to chain several activities together within a single trip chain, relative to other travel modes. Using household travel diary/survey data, the goal of this study is to assess the role ride-hailing currently plays within trip chains. Specifically, the study aims to determine, within trip chains, who uses ride-hailing services, for what trip/activity purposes, and to/from what types of areas, as well as the characteristics of trip chains that involve ride-hailing segments. To meet these objectives, the study estimates a binary logit model using 2017 National Household Travel Survey data, where the dependent variable denotes the inclusion of at least one ride-hailing trip within a trip chain. Similar to the non-trip-chaining ride-hailing literature, this study indicates that trip chains with ride-hailing legs are positively associated with travelers who are younger, live in high-income households, frequently use transit, and reside in high-density areas. However, this study includes novel findings indicating statistically significant relationships between ride-hailing and trip chains that end in healthcare and social/recreational activities. Moreover, trip chains with ride-hailing tend to have fewer stops and longer activity durations than trip chains without ride-hailing. This study also includes nested logit choice models, wherein the dependent variable denotes the primary mode (ride-hailing, transit, personal vehicle, or non-motorized transport) of a trip chain. These model results provide additional insights into the role of ride-hailing within trip chains, as they allow for cross-mode comparisons. The paper discusses the potential transportation planning and policy implications of the model results as well as future research directions.

"Life-changing": the experience of super-responders to biologics in severe asthma.

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.

Preliminary development of a questionnaire to measure the extra-pulmonary symptoms of severe asthma.

BACKGROUND: Research into the effects of asthma treatments on the extra-pulmonary symptoms of severe asthma is limited by the absence of a suitable questionnaire. The aim was to create a questionnaire suitable for intervention studies by selecting symptoms that are statistically associated with asthma pathology and therefore may improve when pathology is reduced. METHODS: Patients attending a specialist asthma clinic completed the 65-item General Symptom Questionnaire (GSQ-65), a questionnaire validated for assessing symptoms of people with multiple medically unexplained symptoms. Lung function (FEV1%) and cumulative oral corticosteroids (OCS) calculated from maintenance dose plus exacerbations were obtained from clinic records. Pathology was represented by the two components of a principal component analysis (PCA) of FEV1% and OCS. LASSO regression was used to select symptoms that had high coefficients with these two principal components and occurred frequently in severe asthma. RESULTS: 100 patients provided data. PCA revealed two components, one where FEV1% and OCS were inversely related and another where they were directly related. LASSO regression revealed 39 symptoms with non-zero coefficients on one or more of the two principal components from which 16 symptoms were selected for the GSQ-A on the basis of magnitude of coefficient and frequency. Asthma symptoms measured by asthma control questionnaires were excluded. The GSQ-A correlated 0.33 and - 0.34 (p = 0.001) with the two principal components. CONCLUSION: The GSQ-A assesses the frequency of 16 heterogenous non-respiratory symptoms that are associated with asthma severity using the statistical combination of FEV1% and OCS.

Comparison of the sensitivity of patient-reported outcomes for detecting the benefit of biologics in severe asthma.

BackgroundThe sensitivity of patient-reported outcomes (PROs) to detect the effects of treatment change depends on the match between the change in items of the PRO and the change that takes place in a sample of people. The aim of this study is to compare the sensitivity of different PROs in detecting changes following the initiation of biologic treatment in asthma. Methods: Patients starting a biologic treatment as part of clinical care completed the Asthma Control Questionnaire (ACQ-6), the Severe Asthma Questionnaire (SAQ and SAQ-global scores) and the EQ5D (EQ-5D-5L and EQ5D-VAS) at baseline. They completed the ACQ-6, SAQ, SAQ-global and a retrospective global rating of change (GRoC) scale at weeks 4, 8 and 16 and completed the EQ-5D-5L and EQ5D-VAS at week 16. The SAQ-global and EQ5D-VAS differ but both are single item 100-point questions. Sensitivity was measured by Cohen's D effect size at each of the three time points. Results: 110 patients were recruited. Depending on the time of assessment, effect size varied between 0.45 and 0.64 for the SAQ, between 0.50 and 0.77 for the SAQ-global; between 0.45 and 0.69 for ACQ-6; between 0.91 and 1.22 for GRoC; 0.32 for EQ-5D-5L and 0.49 for EQ5D-VAS. Conclusion: The sensitivity to change of a questionnaire varies with the time of measurement. The three asthma-specific prospective measures (SAQ, SAQ-global and ACQ-6) have similar sensitivity to change. The single-item EQ5D-VAS was less sensitive than the asthma specific measures and less sensitive than the single-item SAQ-global. The EQ-5D-5L was least sensitive.

Risk Predictors and Symptom Features of Long COVID Within a Broad Primary Care Patient Population Including Both Tested and Untested Patients.

INTRODUCTION: Symptoms may persist after the initial phases of COVID-19 infection, a phenomenon termed long COVID. Current knowledge on long COVID has been mostly derived from test-confirmed and hospitalized COVID-19 patients. Data are required on the burden and predictors of long COVID in a broader patient group, which includes both tested and untested COVID-19 patients in primary care. METHODS: This is an observational study using data from Platform C19, a quality improvement program-derived research database linking primary care electronic health record data (EHR) with patient-reported questionnaire information. Participating general practices invited consenting patients aged 18-85 to complete an online questionnaire since 7th August 2020. COVID-19 self-diagnosis, clinician-diagnosis, testing, and the presence and duration of symptoms were assessed via the questionnaire. Patients were considered present with long COVID if they reported symptoms lasting ≥4 weeks. EHR and questionnaire data up till 22nd January 2021 were extracted for analysis. Multivariable regression analyses were conducted comparing demographics, clinical characteristics, and presence of symptoms between patients with long COVID and patients with shorter symptom duration. RESULTS: Long COVID was present in 310/3151 (9.8%) patients with self-diagnosed, clinician-diagnosed, or test-confirmed COVID-19. Only 106/310 (34.2%) long COVID patients had test-confirmed COVID-19. Risk predictors of long COVID were age ≥40 years (adjusted Odds Ratio [AdjOR]=1.49 [1.05-2.17]), female sex (adjOR=1.37 [1.02-1.85]), frailty (adjOR=2.39 [1.29-4.27]), visit to A&E (adjOR=4.28 [2.31-7.78]), and hospital admission for COVID-19 symptoms (adjOR=3.22 [1.77-5.79]). Aches and pain (adjOR=1.70 [1.21-2.39]), appetite loss (adjOR=3.15 [1.78-5.92]), confusion and disorientation (adjOR=2.17 [1.57-2.99]), diarrhea (adjOR=1.4 [1.03-1.89]), and persistent dry cough (adjOR=2.77 [1.94-3.98]) were symptom features statistically more common in long COVID. CONCLUSION: This study reports the factors and symptom features predicting long COVID in a broad primary care population, including both test-confirmed and the previously missed group of COVID-19 patients.

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.

A reformulated contextual model of psychotherapy for treating anxiety and depression.

This paper describes a reformulated contextual model that uses cognitive theory (dual process theory), motivation theory (personality) and behavioral adaptation (self-correcting control systems) to show how anxiety and depression are caused, treated and prevented by an interaction between people and contexts. Depression and anxiety are the result of implicit beliefs (not cognitions) that all experience is unrewarding and threatening, these being components of the implicit belief that life is bad. Implicit beliefs are formed automatically from contextual cues and in healthy individuals are consistent with rational appraisal. They become more negative than reality through a process of adaptation when behaviors, directed by rational thinking, repeatedly create cues that signify lack of reward or threat. Such behaviors occur when social or other obligations lead people to choose behaviors that fail to satisfy their own unique goals in life and approach threatening situations, contrary to their automatic reactions. Therapeutic interventions and lifestyle change reverse these adaptive processes by positive experiences that create positive implicit beliefs, a change effected in different ways by contextual and specific mechanisms both of which correct the same fault of negative implicit beliefs. Effective therapeutic relationships and interventions are achieved by detecting and responding to a patient's unique needs and goals and their associated implicit beliefs. Mental health requires not only that people experience life as good as defined by their own goals and beliefs but also the avoidance of contexts where social and other pressures induce people to behave in ways inconsistent with their automatically generated feelings.

Comparison of the effects of pulmonary and extra-pulmonary symptoms on health-related quality of life in patients with severe asthma.

OBJECTIVES: To survey the frequency of extra-pulmonary symptoms reported by a sample of patients with severe asthma, their contribution to quality of life and relationship to treatment pathways. METHODS: Consenting patients (N = 100) attending a severe asthma clinic completed questionnaire measures of extra-pulmonary symptoms (the General symptom Questionnaire, GSQ), pulmonary symptoms (Asthma Control Test, ACT), quality of life (the Severe Asthma Questionnaire, SAQ) and health status (EQ-5D-5L). RESULTS: A median of 21 extra-pulmonary symptoms were reported per week. GSQ correlated -0.65 with the ACT and 0.69 with the SAQ. Linear regression showed that both the ACT and GSQ were significant predictors of SAQ mean score, p < 0.001. In patients not receiving biologics, those with high cumulative OCS exposure (≥1120 mg per year) had significantly worse scores (p < 0.05) on all questionnaires except the ACT and GSQ compared to those with low cumulative OCS exposure. DISCUSSION: Extra-pulmonary symptoms were common in this sample of people with severe asthma. Extra-pulmonary and pulmonary symptoms contribute equal variance to the score of HRQoL, showing that they are equally important contributors to patients' experience of severe asthma. Extra-pulmonary symptoms are often overlooked in clinical medicine and in measures of quality of life. Participants receiving biologic treatments had lower extra-pulmonary symptoms possibly indicating that biologics reduce systemic symptoms more effectively than other treatments.

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.

Symptom frequency and development of a generic functional disorder symptom scale suitable for use in studies of patients with irritable bowel syndrome, fibromyalgia syndrome or chronic fatigue syndrome.

OBJECTIVES: To describe the extent to which irritable bowel syndrome (IBS), fibromyalgia syndrome (FMS), and chronic fatigue syndrome (CFS) exhibit symptom overlap, and to validate a patient-derived, generic symptom questionnaire. METHODS: A patient-derived 61-item symptom-frequency questionnaire was completed by participants recruited through IBS, FMS and CFS self-help websites. Principal axis factor analysis with oblimin rotation was performed separately for those reporting an IBS, FMS or CFS diagnosis. RESULTS: Questionnaires were completed by 1751 participants of whom 851 reported more than one of the three diagnoses. Stomach pain on at least a weekly basis was reported by 79% of IBS, 52% of FMS, and 43% of CFS single diagnosis participants. Pain increasing the day after activity was reported by 32% of IBS, 94% of FMS, and 85% of CFS single diagnosis participants. Waking still tired at least once weekly was reported by 75% of IBS, 97% of FMS, and 95% of CFS single diagnosis participants. Exploratory factor analysis produced consistent results across all three diagnostic groups, the 61 items loading on 12 correlated factors with a single higher order factor on which all items loaded. Frequency analysis led to the rejection of one item (cold sores on or near lips), and freeform reporting by participants of additional symptoms identified an additional five, namely, restless legs, hair loss/brittle hair/thinning, dizziness/balance problems, blurred vision and urination problems. CONCLUSIONS: IBS, FMS and CFS are polysymptomatic spectrum disorders with a wide range of overlapping symptoms, many of which are unrelated to diagnostic criteria. Frequency analysis and factor analysis confirm the validity of using the same questionnaire across different diagnostic categories. The 65-item general symptom questionnaire (GSQ-65) is a valid generic symptom scale suitable for assessing the many different symptoms of people with IBS, FMS and CFS.

Functional disorders can also be explained through a non-reductionist application of network theory.

A network structure explains why reductionism is not possible for mental illness, but the same argument applies for the somatic symptoms of functional disorders. Because the covariation of symptoms of functional disorders cannot be explained in terms of symptom-to-symptom causality, explanation requires a network of biological mechanisms having emergent properties that cannot be reduced to biology.

Tailoring Self-Help Mindfulness and Relaxation Techniques for Stroke Survivors: Examining Preferences, Feasibility and Acceptability.

Objective: Studies on psychological techniques to reduce stroke-related anxiety and/or distress are limited. More scarce is research on tailoring such techniques to suit stroke survivors' needs, including the needs of those with aphasia. To address this gap, we report two sequential studies. Study 1 explored preferred psychological techniques (i.e., mindfulness and relaxation) and ways to modify them for stroke survivors, including those with communication difficulties. Study 2 examined the feasibility and acceptability of these modified techniques with a new sample of survivors. Design: Mixed-methods using qualitative and quantitative approach in both studies. Participants: All participants were stroke survivors living in the community (Study 1: n = 13, median age = 61 years; Study 2: n = 38, median age = 67 years). Interventions and Procedures: Study 1: seven techniques representing commonly used types of mindfulness and relaxation were filmed on a professionally produced DVD. Participants feedback on how these techniques could be tailored to meet their needs, their preferences for techniques and reasons for likes and dislikes. Study 2: four favored techniques from study 1 were modified and re-filmed into a new DVD. A new group of participants were asked to practice them twice daily, five times a week for at least 4 weeks. They completed questionnaires at the start of the study (T1), returned approximately 4 weeks later completing the same measures (n = 24 at T2). Focus group discussions/interviews were conducted at the end of T2 exploring the feasibility and acceptability of these techniques. Results: Four techniques were favored by participants in Study 1. After adaptation, these techniques were generally perceived as acceptable, user-friendly and beneficial to participants who participated in the focus groups /interviews in Study 2. A 'once a day' practice frequency could make practicing more feasible. Participants also preferred having choices- multiple techniques could be more useful than single technique. Conclusion: Tailoring psychological techniques for stroke survivors is beneficial. Tailored techniques in a self-help DVD format seemed feasible and acceptable, however, a less frequent practice would be easier for stroke survivors. Future studies should seek to recruit a more heterogenous sample as well as implementing strategies to increase the retention rate.

Still Fighting for Breath: a patient survey of the challenges and impact of severe asthma.

We conducted a large global survey, Still Fighting for Breath, in patients with severe persistent asthma, 10 years after the Fighting for Breath survey to assess the impact of disease on patients' lives and to determine if control and management have changed in recent years. Data were collected from 1333 adults (aged >18 years) and caregivers of children (aged 6-17 years) with severe persistent asthma from nine countries through an online survey conducted in 2016 by GfK. A decade after the first survey, our results showed that the impact of severe asthma has not changed significantly and a high proportion of patients with severe asthma remain inadequately controlled. A large discrepancy was observed between the proportion of patients who perceived their asthma to be well controlled (42%) and the proportion of patients who reported to be well controlled as per the Global Initiative for Asthma (GINA) assessment (6%). Although most patients perceived their asthma to be controlled, many experienced frequent symptoms that affected their daily lives. Thus, there is a need for improved management (support and strategies) of patients with severe persistent asthma and improved coordination of efforts that would enable these patients to achieve better disease control.

The construction and validation of the Severe Asthma Questionnaire.

The US Food and Drug Administration's procedure for scale validation requires a documented stepwise process of qualitative and quantitative data. The aim of this paper is to provide final quantitative validating data for the Severe Asthma Questionnaire (SAQ).The SAQ, Asthma Control Test, Mini Asthma Quality of Life Questionnaire and EQ-5D-5L were completed by 160 patients attending a severe asthma clinic; 51 patients completed the SAQ on two occasions for test-retest reliability analysis. The SAQ produces two scores, a SAQ score based on the average of 16 items and a SAQ-global score from a single 100-point global quality of life scale.Construct validity was demonstrated by factor analysis of the 16 items, convergent validity by correlations of >0.6 between the SAQ, SAQ-global and other questionnaires, and discriminant validity by the ability of the SAQ and SAQ-global to distinguish between different treatment levels. Test-retest reliability (intra-class correlation) was 0.93 for the SAQ and 0.93 for the SAQ-global, and the alpha coefficient for the SAQ was 0.93.The SAQ was developed using recommended qualitative and quantitative procedures for scale development, and can be used to gain insight into patients' perceptions of how severe asthma and its treatment affects their lives.

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.