title: The development and first validation of the Manchester Early Morning Symptoms Index (MEMSI) for patients with COPD.
abstract: OBJECTIVE
  Early morning symptoms (EMS) in people with COPD are associated with poor health, impaired activities and increased exacerbation risk. We describe the development and preliminary validation of the Manchester Early Morning Symptom Index (MEMSI) to quantify EMS in COPD.
  
  
  METHODS
  Focus groups and cognitive debriefing with patients with COPD were used to develop the potential item list, followed by a cross-sectional study to finalise the items for inclusion. In addition to test-retest reliability, comparisons with the St George's Respiratory Questionnaire-C (SGRQ-C), modified Medical Research Council Dyspnoea Scale, Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) and Hospital Anxiety and Depression Scale (HADS) evaluated construct validity. Hierarchical methods informed item deletion and Rasch analysis was applied to assess scale unidimensionality.
  
  
  RESULTS
  23 items were identified from the focus groups and debriefings. The cross-sectional study involved 203 patients with COPD (mean age 64.7 SD 7.5 years, male 63%, Global Initiative for Chronic Obstructive Lung Disease (GOLD): 1:14% 2:41% 3:25% 4: 7%). 13 items were removed during item reduction. MEMSI contains 10 items, demonstrates good overall fit to the Rasch model (χ(2) p=0.26) and item score distribution; excellent reliability (Person Separation Index: 0.91) and good test-retest repeatability (r=0.82). It correlates with the SGRQ-C (r=0.73), FACIT-F (r=-0.65) and HADS (r=0.53-0.54) indicating good construct validity.
  
  
  CONCLUSIONS
  MEMSI is a reliable and valid unidimensional measure of EMS for patients with COPD. It is simple to use and score supporting its suitability for research and clinical use. Work is underway to determine the minimal clinical important difference and cross-cultural validity.
authors.affiliation: The Medicines Evaluation Unit, Manchester, UK.
authors.forename: Adam P
authors.initials: AP
authors.lastname: Garrow
authors.affiliation: The Medicines Evaluation Unit, Manchester, UK.
authors.forename: Naimat
authors.initials: N
authors.lastname: Khan
authors.affiliation: Stroke & Vascular Research Centre, School of Nursing, Midwifery & Social Work, Jean McFarlane Building, University of Manchester, Manchester, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Tyson
authors.affiliation: Respiratory Research Group, 2nd Floor Education and Research Centre, Wythenshawe Hospital, Manchester, UK.
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
authors.affiliation: Medicines Evaluation Unit, University of Manchester, University Hospital of South Manchester Foundation Trust, Manchester, UK.
authors.forename: Dave
authors.initials: D
authors.lastname: Singh
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane University, University Place, Manchester, UK.
authors.forename: Janelle
authors.initials: J
authors.lastname: Yorke
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D002940:Circadian Rhythm; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D011594:Psychometrics / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D006113:United Kingdom
keywords: COPD epidemiology