Development and the initial validation of a new self-administered questionnaire for an early detection of health status changes in smokers at risk for chronic obstructive pulmonary disease (MARKO questionnaire)

Abstract

AimTo develop and do an initial validation of a new simple tool (self-administered questionnaire) that would be sensitive and specific enough to detect early changes in smokers leading to future development of chronic obstructive pulmonary disease (COPD).Methods224 consecutive participants (50.9% women), with mean ± standard deviation age of 52.3 ± 6.7 years, 37.5 ± 16.7 pack-years smoking history (85.8% active smokers), and no prior diagnosis of COPD were recruited. The MARKO questionnaire was self-administered twice; at the general practitioner's office and after 2-4 weeks at the tertiary care hospital. Participants were assessed for COPD by a pulmonologist after filling in a quality of life (QoL) questionnaires, history-taking, physical examination, lung function test, 6-minute walk test, and laboratory tests. They were divided into four subgroups: “healthy” smokers, symptomatic smokers, and smokers with mild and moderately severe COPD.ResultsPsychometric analyses indicated that the 18-item questionnaire had a very good internal consistency (Cronbach’s alpha = 0.91) and test-retest reliability for a four week period (ρc = 0.89, 95% confidence interval [CI] 0.85-0.92, Lin’s concordance). A significant correlations of MARKO scores were found with two QoL questionnaires; r = 0.69 (P < 0.001) and r = 0.81 (P < 0.001). Receiver operating characteristic curve analysis showed an area under the curve of 0.753 (95% CI 0.691-0.808, P < 0.001), with a sensitivity of 71.83% and specificity of 64.24% to discriminate “healthy” smokers from other subgroups.ConclusionBased on psychometric analyses and high convergent validity correlation with already validated QoL questionnaires, the newly developed MARKO questionnaire was shown to be a reliable self-administered short health status assessment tool.Trial registrationClinicaltrial.gov NCT01550679

Early detection of COPD patients in GOLD 0 population: an observational non-interventional cohort study - MARKO study

“…Phase I of the MARKO study will be used to test the psychometric characteristics of the MARKO questionnaire; to evaluate discriminative power of the MARKO questionnaire together with COPD-6™ measurements between different developmental stages of COPD; to identify diagnostic parameters that are most sensitive for early impairment in COPD (discriminate between COPD GOLD 0 and 1); to compare the MARKO questionnaire with other measures used to evaluate patients (HRQoL, history, physical, lung function, functional capacity); and to assess the prevalence of different stages of COPD (specifically GOLD 0 and 1) in the population at risk for COPD. Preliminary data from Phase I of initial validation of the MARKO questionnaire showed the potential for the MARKO questionnaire to assess early health status changes in smokers at risk for chronic obstructive pulmonary disease [ 31 ]. Although exclusion criteria were introduced to exclude subjects with acute/subacute clinical disorders or states of recovery from major clinical disorders representing an absolute or relative contraindication for spirometry or significantly influencing the diagnostic process, the data analysis showed that more than half (56.3%) of the recruited subjects had one or more (up to 3) comorbidities (28.6% hypertension, 10% dyslipidemia, 5.2% diabetes and 4.9% peptic syndrome, etc.)…”

“…Although exclusion criteria were introduced to exclude subjects with acute/subacute clinical disorders or states of recovery from major clinical disorders representing an absolute or relative contraindication for spirometry or significantly influencing the diagnostic process, the data analysis showed that more than half (56.3%) of the recruited subjects had one or more (up to 3) comorbidities (28.6% hypertension, 10% dyslipidemia, 5.2% diabetes and 4.9% peptic syndrome, etc.) [ 31 ].…”

Breathlessness and “exacerbation” questions predictive for incident COPD (MARKO study): data after two years of follow-up

“…The MARKO questionnaire is a newly constructed HRQoL questionnaire developed by a group of experts. The questionnaire and the psychometric characteristics were already published elsewhere ( Vrbica et al, 2016 ). The questionnaire comprises 18 questions covering the manifestation and frequency of the symptoms already present at early stages of COPD ( Supplemental Material ).…”