BackgroundThis study aimed to examine the distribution of predefined phenotypes, demographic data, clinical outcomes, and treatment of patients who were included in the Polish cohort of the Phenotypes of COPD in Central and Eastern Europe (POPE) study.Patients and methodsThis was a sub-analysis of the data from the Polish cohort of the POPE study, an international, multicenter, observational cross-sectional survey of COPD patients in Central and Eastern European countries. The study included patients aged >40 years, with a confirmed diagnosis of COPD, and absence of exacerbation for at least 4 weeks before study inclusion. A total of seven Polish centers participated in the study.ResultsAmong the 430 Polish COPD patients enrolled in the study, 61.6% were non-exacerbators (NON-AE), 25.3% were frequent exacerbators with chronic bronchitis (AE CB), 7.9% were frequent exacerbators without chronic bronchitis (AE NON-CB), and 5.1% met the definition of asthma-COPD overlap syndrome (ACOS). There were statistically significant differences among these phenotypes in terms of symptom load, lung function, comorbidities, and treatment. Patients with the AE CB phenotype were most symptomatic with worse lung function, and more frequently reported anxiety and depression. Patients with the ACOS phenotype were significantly younger and were diagnosed with COPD earlier than those with other COPD phenotypes; those with the ACOS phenotype were also more often atopic and obese.ConclusionThere is significant heterogeneity among COPD patients in the Polish population in terms of phenotype and clinical outcome. The non-exacerbator phenotype is observed most frequently in Poland, while the frequent exacerbator with chronic bronchitis phenotype is the most symptomatic.

Patient-related outcomes measures could provide important information for the current state of the art in medical care and even have an impact on macrodecisions in the health care system. Patient-related outcomes were initially defined as subjective health indicators that allow disability and illness to be assessed, based on patient, caregiver, or physician self-reports. As illness involves psychological and behavioral complex processes of care, a multidisciplinary approach in measuring patient-reported outcomes should be recommended, such as quality of life questionnaires. Patient-related outcomes measures should correspond to specific clinical situations and bring opportunities to improve quality of care. Objective measurements enable quantitative data to be collected and analyzed. Depending on the aim of the research, investigators can use existing methods or develop new tools. This publication presents a methodology for developing patient-related outcomes measures, based on a multistage procedure. The proper definition of specific study objectives and the methodology of instrument development are crucial for successfully transferring the study concept. The model of instrument development is the process of starting from the preliminary phase and includes questionnaire design and scaling, pilot testing (cognitive debriefing), revision of the preliminary version, evaluation of the new tool, and implementation. Validation of the new instrument includes reliability, reproducibility, internal consistency, and responsiveness. The process of designing the new tool should involve a panel of experts, including clinicians, psychologists (preliminary phase), and statisticians (scale development and scoring), and patients (cognitive debriefing). Implementation of a new tool should be followed by evaluation study – assessment of the tool’s usefulness in clinical practice. An instrument must show not only the expected methodological properties and performance but also a positive contribution to care. The necessity of implementation of direct patient-reporting methods has been highlighted by both the Food and Drug Administration and the European Medicines Agency.

IntroductionAsthma is considered an important problem in children and influences on their everyday functioning. This study was concerned with the impact of asthma on the health‐related quality of life (HRQOL) of newly recognized pediatric asthma patients and their parents.MethodsPatients were identified by a general respiratory survey. HRQOL was assessed by self‐report measures: disease‐specific questionnaire for children, the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and generic for parents—the Quality of Life in Child's Chronic Disease Questionnaire (QLCCDQ).ResultsTwenty‐nine newly diagnosed asthmatic children aged 7–11 years (mean age = 8.6; SD = 1.4) were identified from a population‐based respiratory health survey. The most impaired HRQOL domains differed in parents and children. In children, activity limitation was the most impaired; however in parents, emotional functioning and symptom perception domains were most impaired. There were no statistically significant differences in patient and parental HRQOL observed in either the group where symptoms were present or in the group were symptoms were not present. Baseline spirometry showed correlation for FEV1%FVC and PAQLQ symptom domain (r = 0.42). Exercise test showed correlations between FEV1%FVC and QLCCDQ emotional domain (r = 0.7); MEF 25–75% and family roles (r = 0.81), as well as social functioning (r = 0.81). Activity limitation on the PAQLQ correlated with the MEF 25–75% (r = 0.44) and PEF (r = 0.55).ConclusionsHRQOL newly recognized children with asthma and their parents does not correlate closely with clinical status. Patient and parental HRQOL should be considered as independent dimensions. Pediatr Pulmonol. 2010;45:1095–1102. © 2010 Wiley‐Liss, Inc.

BackgroundChildhood chronic disease may affect patients' and their family's functioning. Particularly parents, who play an important role in cooperation between patient and health care professionals, report impaired health - related quality of life (HRQOL). The aim of this study was development, evaluation and validation of a new instrument: Quality of Life in a Child's Chronic Disease Questionnaire (QLCCDQ). The questionnaire is addressed to parents of children with a chronic disease.MethodsStudy design included semi structured interview and qualitative study, which allowed to identify most troublesome problems. Following the results the questionnaire was developed, which consists of 15 questions and covers domains - emotions, patients -perceived symptoms, roles limitations. An observational study involving parents of asthma and diabetes children was conducted to assess the psychometric characteristics of the measure. Psychometric testing was based on the reliability of defined subscales, construct validity, reproducibility assessment, as well as comparison between stable/unstable disease stages and parents of healthy children.ResultsMost troublesome concerns for parents of child with chronic disease included emotional distress and feeling depressed due to child's disease, avoiding social interactions due to child's disease or symptoms. 98 parents of children with asthma or insulin - depended diabetes participated in the psychometric testing of QLCCDQ. Internal consistency reliability for the defined subscales ranged between 0.77 and 0.93. Reproducibility based on the weighted kappa coefficients showed expected level of agreement and was almost perfect in case of 8 questions, substantial for 5 questions and moderate for 2 questions. QLCCDQ demonstrated very good construct validity - all subscales showed statistically significant correlations ranging from 0.4 to 0.9. QLCCDQ scores differed significantly by clinical status - parents of children qualified as stable presented higher scores in most subscales in comparison to parents of children with unstable disease.ConclusionsThe QLCCDQ shows good internal consistency, test-retest reliability, and construct validity. The questionnaire may be useful in helping to understand the impact of chronic child's disease on parental perception of health outcomes.

Objectives: Diagnostic patterns play a role in asthma prevalence estimates and could have implications for disease management. We sought to determine the extent to which questionnaire-derived estimates of childhood asthma reflect the disease's true occurrence. Materials and Methods: Children aged 6-12 years from Katowice, Poland, were recruited from a crosssectional survey (N = 1822) via primary schools. Students were categorized into three mutually exclusive groups based on survey responses: "Asthma" (previously diagnosed asthma); "Respiratory symptoms" (no previous diagnosis of asthma and one or more respiratory symptoms during last year), "No respiratory symptoms" (no previous diagnosis of asthma or respiratory symptoms). A sample of children from each group (total N = 456) completed clinical testing to determine asthma presence according to GINA recommendations. Results: Based on the survey, 5.4% of children were classified with asthma, 27.9% with respiratory symptoms, and 66.7% with no respiratory symptoms or asthma. All previously known 41 cases of asthma were confirmed. New diagnoses of asthma were made in 21 (10.9%) and 8 (3.6%) of subjects from the "Respiratory symptoms" (N = 192) and "No respiratory symptoms" (N = 223) groups, respectively. The overall prevalence of childhood asthma, incorporating the results of clinical examination, was 10.8% (95% CI: 9.4-12.2), compared to the questionnairederived figure of 5.4% (95% CI: 4.4-6.5%) and affected females more than males. Conclusions: Asthma prevalence was underestimated in this population possibly resulting from under-presentation or under-diagnosis. This could have potential implications for proper management and well-being of children. Questionnaire estimates of prevalence should be considered carefully in the context of regional diagnostic patterns.