Defining a Severe Asthma Super-Responder: Findings from a Delphi Process (original) (raw)
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Assessing the responsiveness of the Asthma Quality of Life Questionnaire with pharmaceutical care
Pharmacy World & Science, 2008
Objective To assess the responsiveness of the Asthma Quality of Life Questionnaire (AQLQ) in the context of pharmaceutical care delivery New Zealand community pharmacy setting. Setting Community pharmacy practices in three locations in the Otago and Southland region of New Zealand. Method About 62 patients with asthma (17-80 years of age) were recruited in five community pharmacies in the Otago and the Southland region of New Zealand. Patients were randomly assigned to two groups (Group 1 and Group 2). The AQLQ and a study-specific outcomes questionnaire were administered to both groups at baseline (T1), then again (with an additional global Self-Assessment of change question) 3 months later (at T2) after providing the service to Group 1. Responsiveness of the AQLQ was assessed by measuring the ability of the AQLQ to detect within-subject change in patients who subjectively indicated change, and to distinguish between two groups of patients: those who indicated change and those who indicated no change. Additionally, the correlation between the change of the AQLQ scores at T2 and the patients' self-assessment of change at T2 was estimated and used as means for assessing the AQLQ responsiveness. Main outcome measure Asthma-specific quality of life as measured by the AQLQ and change in quality of life as perceived by participants. Results The results supported the responsiveness of three out of the four domains of the Asthma Quality of Life Questionnaire. The fourth domain, Environmental stimuli, showed weaker responsiveness, and the reasons of this were discussed. Conclusion This study provided data supporting the responsiveness of the AQLQ when used in the context of pharmaceutical care. However, while the AQLQ's Activity Limitation, Symptoms and Emotional domains reflected adequate sensitivity to change in QoL over time, its Environmental domain was less sensitive. Researchers conducting longitudinal studies utilising the AQLQ in pharmaceutical care interventions should bear this in mind, and should consider the possible reasons for this apparent lack of responsiveness, and its implications.
npj Primary Care Respiratory Medicine
The Salford Lung Study in Asthma (SLS Asthma) was a multicentre, randomised, controlled, open-label trial that assessed initiating once-daily, single-inhaler fluticasone furoate/vilanterol (FF/VI) 100 μg/25 μg or 200 μg/25 μg versus continuing usual care. A subgroup (n = 400) from SLS Asthma was enrolled in this exploratory, interview-based follow-up study. Quantitative and qualitative data were collected via questionnaires. The primary objective was to capture patient-centred outcomes (symptom experience, quality of life [QoL], disease management behaviours) and patient experience. Secondary objectives were to assess the correlation of patient-reported outcomes with pre-defined variables from SLS Asthma (Asthma Control Test [ACT] score). The follow-up sample was representative of the SLS Asthma population; half reported asthma improvement during the study. Breathlessness was the most likely symptom to improve (47.8% of patients reported improvement). Most patients reported 'no change' in overall QoL (57.5%) and daily life domains (functioning 66.3%, activities 68.3%, relationships 86.8%, psychological 68.5%). Functioning was reported as the most frequently improved domain (29.8% of patients). Perceived improvement in asthma control (42.5%) and confidence (37.3%) was frequent. ACT responders (defined as patients achieving an ACT score ≥20 and/or an increase of ≥3 in ACT score from baseline at Week 52) were more likely to report asthma improvement (88.7% of patients reporting 'a lot' of improvement) than non-responders. Patients' asthma experiences generally improved during SLS Asthma. Clinical improvements were often associated with perceived improvement by patients, particularly among ACT responders.
Chest, 2019
Approximately 5%-10% of patients with asthma have severe asthma (SA). Accurate provider assessments of asthma control and treatment effectiveness are vital to optimize management. Few real-world studies have examined concurrent assessments of these factors by patients with SA and their providers. METHODS: CHRONICLE (NCT03373045) is an ongoing observational study of patients with SA treated by US allergists or pulmonologists. Eligible patients are adults ($18 y) receiving biologics and/or maintenance systemic corticosteroids (mSCS) or who are uncontrolled (per ATS/ERS criteria) while receiving high-dosage inhaled CS with additional controllers (HD ICS+). Sites are directed to approach all eligible patients under their care. At the time of analysis, for HD ICS+ patients not receiving biologics or mSCS, only every third patient could enroll due to expected higher prevalence. At enrollment, physicians reported their assessment of asthma control and patients completed an online Asthma Control Test (ACT); both completed the 5-point Global Evaluation of Treatment Effectiveness (GETE). Physicians and patients were blinded to each other's responses. Results were summarized for patients enrolled between Feb 27, 2018 and Dec 1, 2018.
Identifying and appraising outcome measures for severe asthma: a systematic review
European Respiratory Journal
BackgroundValid outcome measures are imperative to evaluate treatment response, yet the suitability of existing end-points for severe asthma is unclear. This review aimed to identify outcome measures for severe asthma and appraise the quality of their measurement properties.MethodsA literature search was performed to identify “candidate” outcome measures published between 2018 and 2020. A modified Delphi exercise was conducted to select “key” outcome measures within healthcare professional, patient, pharmaceutical and regulatory stakeholder groups. Initial validation studies for “key” measures were rated against modified quality criteria from COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). The evidence was discussed at multi-stakeholder meetings to ratify “priority” outcome measures. Subsequently, four bibliographic databases were searched from inception to 20 July 2020 to identify development and validation studies for these end-points. Two r...
REVIEW ARTICLE OPEN Patient-reported outcome measures for asthma
2016
BACKGROUND: Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care. AIMS: To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings. METHODS: We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs. RESULTS: We identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child's caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments. CONCLUSIONS: We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes.
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2003
Generic health status has been recommended to be measured separately from disease-specific health status, because they can yield complementary information. In particular, generic health status can provide comprehensive health ratings across various disorders. However, the weakness with generic measures is that they may be less responsive to clinical changes than disease-specific ones. Therefore, when using generic health status as an endpoint in clinical trials, the instrument to be used is a problem with respect to responsiveness. In the present study, we investigated and compared the responsiveness of health status measures during asthma treatment using three different generic instruments: the Medical Outcomes Study Short Form 36-items Health Survey (SF-36), the Nottingham Health Profile (NHP) and the EQ5D (EuroQoL), as well as one disease-specific instrument, the Asthma Quality of Life Questionnaire (AQLQ). Fifty-four new patients with asthma who consulted our clinic were recruit...
Brief Questionnaires for Patient-Reported Outcomes in Asthma
Chest, 2006
Study objectives and design: Health-related quality of life (QoL) instruments are generally used for studies of asthma in specialized settings. For primary care use, there is a need for brief and simple questionnaires for structured patient-reported outcomes. We validated the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ), using the Asthma Quality of Life Questionnaire with standardized activities (AQLQ[S]) as the "gold standard." The Asthma Control Questionnaire (ACQ) was validated against the symptoms domain of the AQLQ(S). Patients were characterized by the Short Form-36 Health Survey (SF-36). Subjects: One hundred eight patients (68 women) with asthma diagnosed by their physicians from 24 primary care centers completed two visits (2 to 3 months apart). Their mean SF-36 scores were lower than the national norm for all domains. Results: The Mini-AQLQ and ACQ correlated well with the AQLQ(S). Reliability, determined in 57 patients with stable AQLQ(S) scores, was good. Both brief questionnaires detected improvement or deterioration of patients at the group level. Global ratings of disease severity by patients or clinicians correlated poorly with disease-specific QoL scores. Conclusions: The Mini-AQLQ and ACQ instruments are sufficiently simple and robust to be suitable for research and quality of care monitoring in primary care at the group level. They may, after further validation, even be useful in the management of individual patients.
Validation of an electronic version of the Mini Asthma Quality of Life Questionnaire
Respiratory Medicine, 2010
Background: The Mini Asthma Quality of Life Questionnaire (MiniAQLQ) is a validated diseasespecific quality of life (QOL) paper (p) questionnaire. Electronic (e) versions enable inclusion of asthma QOL in electronic medical records and research databases. Purpose: To validate an e-version of the MiniAQLQ, compare time required for completion of e-and p-versions, and determine which version participants prefer. Methods: Adults with stable asthma were randomized to complete either the e-or p-Mini-AQLQ, followed by a 2-h rest period before completing the other version. Agreement between versions was measured using the intraclass correlation coefficient (ICC) and BlandeAltman analysis. Results: Two participants with incomplete p-MiniAQLQ responses were excluded. Forty participants (85% female; age 47.7 AE 14.9 years; asthma duration 22.6 AE 16.1 years; FEV 1 87.1 AE 21.6% predicted) with both AQLQ scores <6.0 completed the study. Agreement between e-and p-versions for the overall score was acceptable (ICC Z 0.95) with no bias (difference (D) pee Z 0.1; P Z 0.21). ICCs for the symptom, activity limitation, emotional function and environmental stimuli domains were 0.94, 0.89, 0.90, and 0.91 respectively. A small but significant bias (D Z 0.3; P Z 0.004) was noted in the activity limitation domain. Completion time was significantly longer for the e-version (3.8 AE 1.9 min versus 2.7 AE 1.1 min; P < 0.0001). The majority of patients (57.5%) preferred the e-MiniAQLQ; 35% had no preference. a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / r m e d Respiratory Medicine (2010) 104, 658e667