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Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis.

ABSTRACT: Little is known about whether or how supplemental oxygen affects patients with pulmonary fibrosis.A mixed-methods study is described. Patients with pulmonary fibrosis, informal caregivers of pulmonary fibrosis patients and practitioners who prescribe supplemental oxygen will be interviewed to gather data on perceptions of how supplemental oxygen impacts patients. In addition, three hundred pulmonary fibrosis patients who do not use daytime supplemental oxygen will be recruited to participate in a longitudinal, pre-/post- study in which patient-reported outcome (PRO) and activity data will be collected at baseline, immediately before daytime supplemental oxygen is initiated, and then once and again 9-12 months later. Activity data will be collected using accelerometers and portable GPS data recorders. The primary outcome is change in dyspnea from before to one month after supplemental oxygen is initiated. Secondary outcomes include scores from PROs to assess cough, fatigue and quality of life as well as the activity data. In exploratory analyses, we will use longitudinal data analytic techniques to assess the trajectories of outcomes over time while controlling for potentially influential variables.Throughout the study and at its completion, results will be posted on the website for our research program (the Participation Program for Pulmonary Fibrosis or P3F) at http://www.pulmonaryfibrosisresearch.org.

SUBMITTER: Belkin A

PROVIDER: S-EPMC4232731 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis.

Belkin Amanda A Fier Kaitlin K Albright Karen K Baird Susan S Crowe Brenda B Eres Linda L Korn Marjorie M Maginn Leslie L McCormick Mark M Root Elisabeth D ED Vierzba Thomas T Wamboldt Frederick S FS Swigris Jeffrey J JJ

BMC pulmonary medicine 20141101

<h4>Background</h4>Little is known about whether or how supplemental oxygen affects patients with pulmonary fibrosis.<h4>Methods/design</h4>A mixed-methods study is described. Patients with pulmonary fibrosis, informal caregivers of pulmonary fibrosis patients and practitioners who prescribe supplemental oxygen will be interviewed to gather data on perceptions of how supplemental oxygen impacts patients. In addition, three hundred pulmonary fibrosis patients who do not use daytime supplemental o ...[more]

PMID: 25361630

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Project description:BACKGROUND:Dyspnea is the hallmark symptom of pulmonary fibrosis. Supplemental oxygen (O2) is prescribed to many patients with pulmonary fibrosis in hopes of alleviating dyspnea and improving physical functioning. We used response data from the University of California San Diego Shortness of Breath Questionnaire (UCSD) which was administered monthly in the context of a longitudinal, observational study to plot a rich trajectory for dyspnea over time in patients with pulmonary fibrosis. We used other data from that study to identify clinical predictors of being prescribed O2 and to provide additional information for how UCSD scores could be used for clinical purposes. METHODS:We used linear mixed-effects models and multivariate Cox proportional hazards to model change in dyspnea scores over time and to identify significant predictors of time-to-O2-prescription among a pool of clinically-meaningful candidate variables. In the longitudinal study, all decisions, including whether or not to prescribe O2, were made by subjects' treating physicians, not members of the research team. RESULTS:One-hundred ninety-four subjects with pulmonary fibrosis completed more than one UCSD or were prescribed O2 at some point during the follow-up period (N?=?43). Twenty-eight of the 43 had analyzable, longitudinal data and contribute data to the longitudinal UCSD analyses. All 43 were included in the time-to-O2-prescription analyses. Subjects prescribed O2 had more severe dyspnea at enrollment (38.4?±?19.6 vs. 22.6?±?18.7, p?<?0.0001) and a steeper increase in UCSD scores over time (slope?=?1.18?±?0.53 vs. 0.24?±?0.09 points per month, p?=?0.02) than subjects not prescribed O2. Controlling for baseline UCSD score and FVC%, subjects with a clinical summary diagnosis of idiopathic pulmonary fibrosis (IPF) were far more likely to be prescribed O2 than subjects with other forms of pulmonary fibrosis (hazard ratio?=?4.85, (2.19, 10.74), p?<?0.0001). CONCLUSIONS:Baseline dyspnea and rise in dyspnea over time predict timing of O2 prescription. Accounting for disease severity, patients with IPF are more likely than patients with other forms of pulmonary fibrosis to be prescribed O2. UCSD scores provide clinically useful information; frequent administration could yield timely data on changes in disease status in patients with pulmonary fibrosis. TRIAL REGISTRATION:The longitudinal study is registered on ClinicalTrials.gov ( NCT01961362 ). Registered October 9, 2013.

Project description:Features of the airway microbiome in persons with cystic fibrosis (pwCF) are correlated with disease progression. Microbes have traditionally been classified for their ability to tolerate oxygen. It is unknown whether supplemental oxygen, a common medical intervention, affects the airway microbiome of pwCF. We hypothesized that hyperoxia significantly impacts the pulmonary microbiome in cystic fibrosis. In this study, we cultured spontaneously expectorated sputum from pwCF in artificial sputum medium under 21%, 50%, and 100% oxygen conditions using a previously validated model system that recapitulates microbial community composition in uncultured sputum. Culture aliquots taken at 24, 48, and 72 h, along with uncultured sputum, underwent shotgun metagenomic sequencing with absolute abundance values obtained with the use of spike-in bacteria. Raw sequencing files were processed using the bioBakery pipeline to determine changes in taxonomy, predicted function, antimicrobial resistance genes, and mobile genetic elements. Hyperoxia reduced absolute microbial load, species richness, and diversity. Hyperoxia reduced absolute abundance of specific microbes, including facultative anaerobes such as Rothia and some Streptococcus species, with minimal impact on canonical CF pathogens such as Pseudomonas aeruginosa and Staphylococcus aureus. The effect size of hyperoxia on predicted functional pathways was stronger than that on taxonomy. Large changes in microbial cooccurrence networks were noted. Hyperoxia exposure perturbs airway microbial communities in a manner well tolerated by key pathogens. Supplemental oxygen use may enable the growth of lung pathogens and should be further studied in the clinical setting. IMPORTANCE The airway microbiome in persons with cystic fibrosis (pwCF) is correlated with lung function and disease severity. Supplemental oxygen use is common in more advanced CF, yet its role in perturbing airway microbial communities is unknown. By culturing sputum samples from pwCF under normal and elevated oxygen conditions, we found that increased oxygen led to reduced total numbers and diversity of microbes, with relative sparing of common CF pathogens such as Pseudomonas aeruginosa and Staphylococcus aureus. Supplemental oxygen use may enable the growth of lung pathogens and should be further studied in the clinical setting.

Project description:BACKGROUND:Mental health service managers must take into account multiple factors when making decisions about the best way to deliver care to clients across increasingly larger service areas. This task is made more difficult by the lack of evidence and tools historically available to inform these decisions. In recent decades, the increasing availability of epidemiological and service use data for mental illness has solved the problem of evidence, but there still exists a challenge to make these data easily accessible and understandable for managers. OBJECTIVE:This study aims to develop a simulation modeling tool to allow managers to explore various service configurations in virtual reality, enabling predictions to be made about the cost and quality of care. METHODS:This is a longitudinal, mixed-methods case study, comprising overlapping intervention and evaluation phases. In partnership with senior managers of a mental health program, the researchers will develop a series of simulation models in Arena to address key strategic issues facing the service. Thematic and content analyses of semistructured interviews, meeting observations, and document analysis will be used to evaluate the process of model implementation and the outcomes for both researchers and managers. The study is being conducted in Australia. RESULTS:Data collection has been ongoing since late 2013. To date, 3 prototype simulation models have been developed and presented to senior managers, and 18 evaluation interviews have been conducted. The project is expected to conclude in late 2018. CONCLUSIONS:Findings of this study have the potential to shape decision making in mental health service delivery, by providing key examples of how to integrate patient data using simulation modeling. In addition, the results will provide key insights into how researchers and consultants can effectively implement simulation modeling in real-world health care organizations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/11119.

Project description:INTRODUCTION:Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS:A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION:The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers.

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Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis.

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Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis.

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