Content Validation of Patient-Reported Sleep Measures and Development of a Conceptual Model of Sleep Disturbance in Patients with Moderate-to-Severe, Uncontrolled Asthma

Purpose Sleep disturbance is common in patients with asthma and can lead to subsequent impacts on health-related quality of life (HRQOL). Fit-for-purpose patient-reported outcome measures (PROMs) assessing asthma-related sleep disturbance and next-day HRQOL impact (next-day impact) are needed to evaluate disease burden and treatment effects. Patients and Methods Adults (18–65 years) from three US clinics were recruited for semistructured interviews. Concept elicitation (CE) identified how asthma affects participants’ sleep and how asthma-related sleep disturbances impact their daily lives, which informed conceptual model development. Cognitive debriefing (CD) of the Asthma Sleep Disturbance Questionnaire (ASDQ), Sleep Diary, and Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form 8a (PROMIS SRI SF8a) was completed to assess each measure’s content validity. Results Twelve individuals participated in two interview rounds (6 individuals per round). Participants most frequently reported asthma-related nighttime awakening and decreased sleep quality and duration. Negative impacts of a poor night’s sleep due to asthma symptoms included feeling tired/fatigue/lack of energy and subsequent negative impacts on physical functioning, emotions and mood, mental functioning, work or volunteerism, and social functioning. Across both rounds of CD interviews, participants generally found the Sleep Diary and PROMIS SRI SF8a items relevant and easy to complete with no modifications. The ASDQ was modified for clarity and consistency. Conclusion As described in the conceptual model, asthma affects multiple aspects of sleep that can cause next-day fatigue and other subsequent negative HRQOL impacts. This study demonstrates that the ASDQ, Sleep Diary, and PROMIS SRI SF8a items are comprehensive, relevant, and appropriate for patients with moderate-to-severe, uncontrolled asthma. Evaluation of psychometric properties for the ASDQ, Sleep Diary, and PROMIS SRI SF8a based on clinical trial data in patients with moderate-to-severe, uncontrolled asthma will further support their use.

[1]  H. Al-Jahdali,et al.  The prevalence of sleep disturbance among asthmatic patients in a tertiary care center , 2021, Scientific Reports.

[2]  Eun Sug Park,et al.  Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019 , 2020, Lancet.

[3]  J. Silverberg,et al.  Validation of Patient‐Reported Outcomes Information System Sleep Disturbance and Sleep‐Related Impairment in adults with atopic dermatitis * , 2020, The British journal of dermatology.

[4]  L. Fabbri,et al.  Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. , 2019, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[5]  K. Stone,et al.  Impact of Poor Sleep on Physical and Mental Health in Older Women. , 2018, Sleep medicine clinics.

[6]  S. Hiles,et al.  Health‐related quality of life burden in severe asthma , 2018, The Medical journal of Australia.

[7]  I. Pavord,et al.  Dupilumab Efficacy and Safety in Moderate‐to‐Severe Uncontrolled Asthma , 2018, The New England journal of medicine.

[8]  I. Pavord,et al.  Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma , 2018, Advances in Therapy.

[9]  U. Holmgren,et al.  A cross-sectional survey of night-time symptoms and impact of sleep disturbance on symptoms and health status in patients with COPD , 2017, International journal of chronic obstructive pulmonary disease.

[10]  Joan C. Han,et al.  PROMIS Sleep Disturbance and Sleep-Related Impairment in Adolescents: Examining Psychometrics Using Self-Report and Actigraphy , 2017, Nursing research.

[11]  E. Israel,et al.  Association Between Insomnia and Asthma Burden in the Severe Asthma Research Program (SARP) III. , 2016, Chest.

[12]  Chong-Jen Yu,et al.  Factors responsible for poor sleep quality in patients with chronic obstructive pulmonary disease , 2016, BMC Pulmonary Medicine.

[13]  J. Rejas,et al.  Self-perceived Sleep Quality and Quantity in Adults With Asthma: Findings From the CosteAsma Study. , 2016, Journal of investigational allergology & clinical immunology.

[14]  Yan Liu,et al.  Associations between insomnia, sleep duration and poor work ability. , 2015, Journal of psychosomatic research.

[15]  J. Paterson,et al.  Poor Sleep Quality in Australian Adults With Comorbid Psychological Distress and Physical Illness , 2014, Behavioral sleep medicine.

[16]  Theresa Weldring,et al.  Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs) , 2013, Health services insights.

[17]  C. Morin,et al.  Insomnia and daytime cognitive performance: a meta-analysis. , 2012, Sleep medicine reviews.

[18]  Daniel J Buysse,et al.  Development of Short Forms From the PROMIS™ Sleep Disturbance and Sleep-Related Impairment Item Banks , 2012, Behavioral sleep medicine.

[19]  N. Leidy,et al.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[20]  Elizabeth Molsen,et al.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[21]  Pennifer Erickson,et al.  Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. , 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[22]  David M. Shade,et al.  Sleep Quality in Asthma: Results of a Large Prospective Clinical Trial , 2004, The Journal of asthma : official journal of the Association for the Care of Asthma.

[23]  C. Schwartz,et al.  Response shift theory: important implications for measuring quality of life in people with disability. , 2007, Archives of physical medicine and rehabilitation.

[24]  P. Croft,et al.  Epidemiology of insomnia: a longitudinal study in a UK population. , 2007, Sleep.

[25]  K. Kelsay.  Management of sleep disturbance associated with atopic dermatitis. , 2006, The Journal of allergy and clinical immunology.

[26]  Linda Abetz,et al.  Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. , 2006, Respiratory medicine.

[27]  V. Braun,et al.  Using thematic analysis in psychology , 2006 .

[28]  R. Chervin.  Epworth sleepiness scale? , 2003, Sleep medicine.

[29]  G H Guyatt,et al.  Development and validation of a questionnaire to measure asthma control. , 1999, The European respiratory journal.

[30]  M. Sprangers,et al.  Integrating response shift into health-related quality of life research: a theoretical model. , 1999, Social science & medicine.

[31]  G. Guyatt,et al.  Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. , 1992, Thorax.

[32]  M. Johns,et al.  A new method for measuring daytime sleepiness: the Epworth sleepiness scale. , 1991, Sleep.

[33]  S. Leichtle,et al.  Patient Related Outcome Measures , 2022 .