HO-12-9141 SLS in-depth exit interviews on patient centered outcomes in COPD and asthma

Trial description: Overall aim: The purpose of the study is to conduct follow-up interviews with a subsample of patients completing the Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD). The SLS-COPD is an ongoing 12-month real-world study of treatments (Fluticasone Furoate/Vilanterol Inhalation Powder versus standard of care) in COPD. A mixed methods approach will be adopted, whereby both quantitative and qualitative data are collected to combine the need for both wide-ranging and in-depth information. This exploratory study will be used to gain insight into the patient experience in the SLS-COPD, as well as the impact and management of disease from the patients’ perspective.Rationale: There is increasing recognition of the importance of collecting information on disease and treatment experience from a patient-centred perspective that may not be captured through standardised PRO questionnaires (Baldwin et al., 2011). Specific instruments included in clinical studies are routinely selected for their ability to measure patient-perceived benefits of treatment in relation to key symptom areas (e.g., breathlessness or fatigue), and so may miss certain humanistic concepts, such as identity and self-efficacy, and issues such as disease awareness and treatment seeking behaviour. Moreover, randomised clinical trials typically do not assess the relative importance of dimensions potentially being affected by a disease, and hence do not register the key priorities among patients. They also do not routinely capture potential behavioural or lifestyle risk factors that may impact adherence to treatment and disease exacerbations.The primary objectives are to: (i) Describe the background and lifestyle characteristics of patients taking part in the SLS-COPD; (ii) Describe patient-centred outcomes beyond those captured by standardised instruments administered in the SLS-COPD, focusing on aspects such as symptom experience, sleep, impact on daily life, and overall quality of life (QOL); (iii) Describe patients’ experiences, perceptions and management of disease, focussing on disease awareness, self-management strategies, and treatment seeking behaviour; (iv) Explore attitudes and potential barriers to medication adherenceThe secondary objectives are to: Explore how these factors and outcomes relate to key clinical and adherence outcomes in the SLS-COPD, specifically exacerbations and treatment adherence, as well as to treatment. Analyses per treatment group are conditioned on the extent to which the sample for the follow-up interviews is representative of the main SLS_COPD sample, as defined below.Study design: Exploratory face-to-face and telephone interviews, with a mixed methods approach. Closed-ended questions will be administered to all SLS-COPD patients participating in the follow-up interviews. A subsample of one in ten patients will also be administered additional in-depth, open-ended questions.Study Population and Sampling Methods: A sample of patients completing the SLS-COPD who consent to take part in follow-up interviews within 2 weeks of Visit 6 (end of SLS-COPD). Specifically, the following inclusion criteria apply: (i) SLS-COPD completion: Attending end of study (EOS) visit (Visit 6); (ii) Informed consent: Subjects must be able to provide informed consent, and have their consent signed and dated; (iii) Ability to participate in an interview.Data analysis methods: Qualitative analysis of the open-ended data will be conducted using the expanded interview transcripts and facilitated by the use of ATLAS.ti (version 6.2 or higher). All transcripts will be subject to one primary coding and one secondary coding conducted by separate researchers from RTI HS. A qualitative description approach will be used.Analysis of the closed-ended question data will be conducted using SAS 9.3. The data will be analysed as observed, with no imputation of missing data or aggregation across responses, except in the case of two standardised instruments, which will be scored according to their respective scoring guidelines. Study variables will be analysed descriptively, entailing: frequency and percentage distributions for categorical variables; frequencies and percentages and/or medians and interquartile ranges for ordinal variables; and means and standard deviations, median and interquartile ranges, and score ranges for continuous measures. Selected variables will also be compared descriptively across key SLS-COPD subgroups (exacerbation rate, adherence level, and treatment group,) as defined in the protocol.Sample size: 400Limitations: Exploratory cross-sectional study with no a-priori-defined statistical tests or hierarchy; one year outcomes based on patient recall post SLS-COPD exit