title: The PROactive innovative conceptual framework on physical activity.
abstract: Although physical activity is considered an important therapeutic target in chronic obstructive pulmonary disease (COPD), what "physical activity" means to COPD patients and how their perspective is best measured is poorly understood. We designed a conceptual framework, guiding the development and content validation of two patient reported outcome (PRO) instruments on physical activity (PROactive PRO instruments). 116 patients from four European countries with diverse demographics and COPD phenotypes participated in three consecutive qualitative studies (63% male, age mean±sd 66±9 years, 35% Global Initiative for Chronic Obstructive Lung Disease stage III-IV). 23 interviews and eight focus groups (n = 54) identified the main themes and candidate items of the framework. 39 cognitive debriefings allowed the clarity of the items and instructions to be optimised. Three themes emerged, i.e. impact of COPD on amount of physical activity, symptoms experienced during physical activity, and adaptations made to facilitate physical activity. The themes were similar irrespective of country, demographic or disease characteristics. Iterative rounds of appraisal and refinement of candidate items resulted in 30 items with a daily recall period and 34 items with a 7-day recall period. For the first time, our approach provides comprehensive insight on physical activity from the COPD patients' perspective. The PROactive PRO instruments' content validity represents the pivotal basis for empirically based item reduction and validation.
authors.affiliation: Health Services and Nursing Research, University of Leuven, Leuven, Belgium fabienne.dobbels@med.kuleuven.be.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Dobbels
authors.affiliation: Dept of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands These authors equally contributed.
authors.forename: Corina
authors.initials: C
authors.lastname: de Jong
authors.affiliation: ELEGI Laboratory, Center for Inflammation Research, University of Edinburgh, Edinburgh, UK These authors equally contributed.
authors.forename: Ellen
authors.initials: E
authors.lastname: Drost
authors.affiliation: Lung Foundation Netherlands, Amersfoort, The Netherlands These authors equally contributed.
authors.forename: Janneke
authors.initials: J
authors.lastname: Elberse
authors.affiliation: Dept of Critical Care Medicine and Pulmonary Services, Thorax Foundation, Athens, Greece These authors equally contributed.
authors.forename: Chryssoula
authors.initials: C
authors.lastname: Feridou
authors.affiliation: Health Services and Nursing Research, University of Leuven, Leuven, Belgium These authors equally contributed.
authors.forename: Laura
authors.initials: L
authors.lastname: Jacobs
authors.affiliation: ELEGI Laboratory, Center for Inflammation Research, University of Edinburgh, Edinburgh, UK.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rabinovich
authors.affiliation: Horten Centre and Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland.
authors.forename: Anja
authors.initials: A
authors.lastname: Frei
authors.affiliation: Horten Centre and Institute of Social and Preventive Medicine, University of Zurich, Zurich, Switzerland.
authors.forename: Milo A
authors.initials: MA
authors.lastname: Puhan
authors.affiliation: Lung Foundation Netherlands, Amersfoort, The Netherlands.
authors.forename: Willem I
authors.initials: WI
authors.lastname: de Boer
authors.affiliation: Dept of General Practice, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.affiliation: Outcomes and Evidence, Global Health and Value, Pfizer, Walton Oaks, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Williams
authors.affiliation: Allergy and Respiratory Research Group, Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Hillary
authors.initials: H
authors.lastname: Pinnock
authors.affiliation: Dept of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.
authors.forename: Thierry
authors.initials: T
authors.lastname: Troosters
authors.affiliation: AstraZeneca, Research and Development, Health Economics and Outcomes Research, Medical Science, Mölndal, Sweden.
authors.forename: Niklas
authors.initials: N
authors.lastname: Karlsson
authors.affiliation: Patient Reported Outcomes Division, Novartis, Basel, Switzerland.
authors.forename: Karoly
authors.initials: K
authors.lastname: Kulich
authors.affiliation: Outcomes and Evidence, Global Health and Value, Pfizer, Walton Oaks, UK.
authors.forename: Katja
authors.initials: K
authors.lastname: Rüdell
mesh_terms: D000368:Aged; D005060:Europe; D005260:Female; D017144:Focus Groups; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D010358:Patient Participation; D010641:Phenotype; D011594:Psychometrics; D029424:Pulmonary Disease, Chronic Obstructive / Q000503:physiopathology* / Q000523:psychology; D015203:Reproducibility of Results; D012107:Research Design; D057566:Self Report; D011795:Surveys and Questionnaires