Factors associated with appropriate inhaler use in patients with COPD - lessons from the REAL survey

The authors thank Clarice Field (PhD) and Paul McKiernan (PhD) of Novartis for providing medical writing support, which was funded by Novartis AG, Basel, Switzerland, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). Pankaj Goyal and Joao Mendes, Novartis Pharma AG, Basel, contributed to the design and conceptualization of study. The survey was designed by PDD, London, United Kingdom, and GfK Switzerland AG, Basel, Switzerland. The survey was conducted by GfK Switzerland AG, Basel, Switzerland, and sponsored by Novartis Pharma AG, Basel, Switzerland.Peer reviewedPublisher PD

Greater Dyspnea is Associated with Lower Health-Related Quality of Life among European Patients with COPD

OBJECTIVE: Dyspnea is a defining symptom in the classification and treatment of chronic obstructive pulmonary disease (COPD). However, the degree of variation in burden among symptomatic COPD patients and the possible correlates of burden remain unclear. This study was conducted to characterize patients in Europe currently being treated for COPD according to the level of dyspnea in terms of sociodemographics, health-related quality of life, work productivity impairment, and health care resource use assessed by patient reports. METHODS: Data were derived from the 5-EU 2013 National Health and Wellness Survey (N=62,000). Respondents aged ≥40 years who reported currently using a prescription for COPD were grouped according to their level of dyspnea as per the Global Initiative for Chronic Obstructive Lung Disease guidelines and compared on health status (revised Short Form 36 [SF-36]v2), work impairment (Work Productivity and Activity Impairment questionnaire), and number of health care visits in the past 6 months using generalized linear models with appropriate distributions and link functions. RESULTS: Of the 768 respondents who met the inclusion criteria, 245 (32%) were considered to have higher dyspnea (equivalent to modified Medical Research Council score ≥2). Higher dyspnea was associated with decrements ranging from 3.9 to 8.2 points in all eight domains of the SF-36 health profile after adjustment for sociodemographics, general health characteristics, and length of COPD diagnosis; mental component summary scores and Short Form-6D health utility scores were lower by 3.5 and 0.06 points, respectively. Adjusted mean activity impairment (55% vs 37%, P\u3c0.001) and number of emergency room visits (0.61 vs 0.40, P=0.030) were higher in patients with greater dyspnea. CONCLUSION: Many European patients with COPD continue to experience dyspnea despite treatment and at levels associated with notable impairments in the patients\u27 ability to function across a multitude of domains. These patients may benefit from more intense treatment of their symptoms

Simultaneous development of the Pediatric GERD Caregiver Impact Questionnaire (PGCIQ) in American English and American Spanish

BACKGROUND: The objective of this study was to develop simultaneously a new questionnaire, the Pediatric GERD Caregiver Impact Questionnaire (PGCIQ), in American English and American Spanish in order to elucidate the impact of caring for a child with GERD. METHODS: Two focus group discussions were conducted in American English and American Spanish to develop a relevant conceptual model. Focus group participants were the primary caregivers of children with GERD (newborn through 12 years of age). Participant responses were qualitatively analyzed to identify potential differences in caregiver perspectives by the caregiver's language, socio-economic status and demographic profile as well as the child's age and disease severity level. Items in the PGCIQ were generated simultaneously in English and Spanish by reviewing results of qualitative analysis from focus groups in each language. The PGCIQ was finalized in both languages after testing content validity and conducting an in-depth translatability assessment. RESULTS: Analysis of focus group comments resulted in the development of a first draft questionnaire consisting of 58 items in 10 domains. Content validity testing and an in-depth translatability assessment resulted in wording modification of 37 items, deletion of 14 items and the addition of a domain with five items. Feedback from the content validity testing interviews indicated that the instrument is conceptually relevant in both American English and American Spanish, clear, comprehensive and easy to complete within 10 minutes. The final version of the PGCIQ contains 49 items assessing ten domains. An optional module with nine items is available for investigative research purposes and for use only at baseline. CONCLUSION: The PGCIQ was developed using simultaneous item generation, a process that allows for consideration of concept relevance in all stages of development and in all languages being developed. The PGCIQ is the first questionnaire to document the multidimensional impact of caring for an infant or young child with GERD. Linguistic adaptation of the PGCIQ in multiple languages is ongoing. A validation study of the PGCIQ is needed to examine its psychometric properties, further refine the items and develop an appropriate scoring model

Greater dyspnea is associated with lower health-related quality of life among European patients with COPD

OBJECTIVE: Dyspnea is a defining symptom in the classification and treatment of chronic obstructive pulmonary disease (COPD). However, the degree of variation in burden among symptomatic COPD patients and the possible correlates of burden remain unclear. This study was conducted to characterize patients in Europe currently being treated for COPD according to the level of dyspnea in terms of sociodemographics, health-related quality of life, work productivity impairment, and health care resource use assessed by patient reports. METHODS: Data were derived from the 5-EU 2013 National Health and Wellness Survey (N=62,000). Respondents aged ≥40 years who reported currently using a prescription for COPD were grouped according to their level of dyspnea as per the Global Initiative for Chronic Obstructive Lung Disease guidelines and compared on health status (revised Short Form 36 [SF-36]v2), work impairment (Work Productivity and Activity Impairment questionnaire), and number of health care visits in the past 6 months using generalized linear models with appropriate distributions and link functions. RESULTS: Of the 768 respondents who met the inclusion criteria, 245 (32%) were considered to have higher dyspnea (equivalent to modified Medical Research Council score ≥2). Higher dyspnea was associated with decrements ranging from 3.9 to 8.2 points in all eight domains of the SF-36 health profile after adjustment for sociodemographics, general health characteristics, and length of COPD diagnosis; mental component summary scores and Short Form-6D health utility scores were lower by 3.5 and 0.06 points, respectively. Adjusted mean activity impairment (55% vs 37%, P<0.001) and number of emergency room visits (0.61 vs 0.40, P=0.030) were higher in patients with greater dyspnea. CONCLUSION: Many European patients with COPD continue to experience dyspnea despite treatment and at levels associated with notable impairments in the patients’ ability to function across a multitude of domains. These patients may benefit from more intense treatment of their symptoms

Changes in initial COPD treatment choice over time and factors influencing prescribing decisions in UK primary care : a real-world study

Acknowledgements Samantha Holmes (CircleScience, an Ashfield Company, part of UDG Healthcare plc) and Paul Hutchin (contracted to CircleScience, an Ashfield Company, part of UDG Healthcare plc) provided medical writing assistance. Funding The study was funded by Novartis Pharma AG (Basel, Switzerland).Peer reviewedPublisher PD

The inevitable drift to triple therapy in COPD : an analysis of prescribing pathways in the UK

Acknowledgments The analyses reported in this study were funded by Novartis Pharma AG (Basel, Switzerland) and were conducted by Research in Real-Life Ltd (Cambridge, UK), an independent company. The authors also thank David Bergin, Danielle Corbett, and Vivek Khanna (professional medical writers; Novartis) for assistance in the preparation of this paper. Writing support was funded by Novartis Pharma AG.Peer reviewedPublisher PD

Comparative efficacy of long-acting &beta;2-agonists as monotherapy for chronic obstructive pulmonary disease: a network meta-analysis

Long-acting β2-agonists (LABAs) have demonstrated efficacy in patients with COPD in clinical trials. The purpose of this study was to assess the comparative efficacy of all available dosages of all LABA monotherapies using a network meta-analysis

Erratum : Changes in initial COPD treatment choice over time and factors influencing prescribing decisions in UK primary care: a real-world study

Peer reviewedPublisher PD