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Rationale: Decisions in medicine are made on the basis of knowledge and reasoning, often in shared conversations with patients and families in consideration of clinical practice guideline recommendations, individual preferences, and individual goals. Observational studies can provide valuable knowledge to inform guidelines, decisions, and policy.Objectives: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement to clarify the role of observational studies-alongside randomized controlled trials (RCTs)-in informing clinical decisions in pulmonary, critical care, and sleep medicine.Methods: The committee examined the strengths of observational studies assessing causal effects, how they complement RCTs, factors that impact observational study quality, perceptions of observational research, and, finally, the practicalities of incorporating observational research into ATS clinical practice guidelines.Measurements and Main Results: There are strengths and weakness of observational studies as well as RCTs. Observational studies can provide evidence in representative and diverse patient populations. Quality observational studies should be sought in the development of ATS clinical practice guidelines, and medical decision-making in general, when 1) no RCTs are identified or RCTs are appraised as being of low- or very low-quality (replacement); 2) RCTs are of moderate quality because of indirectness, imprecision, or inconsistency, and observational studies mitigate the reason that RCT evidence was downgraded (complementary); or 3) RCTs do not provide evidence for outcomes that a guideline committee considers essential for decision-making (e.g., rare or long-term outcomes; "sequential").Conclusions: Observational studies should be considered in developing clinical practice guidelines and in making clinical decisions. [ABSTRACT FROM AUTHOR]

Background: Real-life studies are needed to determine the cost-effectiveness of asthma therapies in clinical practice., Aim: To compare the cost-effectiveness of extrafine-particle inhaled corticosteroid (ICS) with standard size-particle ICS in the United Kingdom (UK) and United States (US)., Methods: These retrospective matched cohort analyses used large electronic databases to study asthma-related outcomes for patients in the UK (12-60 years old; n=1730) and US (12-80 years; n=10,312) prescribed extrafine beclomethasone or fluticasone as their first ICS therapy for asthma. Patients were matched on demographic characteristics and asthma severity during 1 baseline year, and asthma control and asthma-related costs were compared during 1 outcome year., Results: In both the UK and US, adjusted odds of risk-domain asthma control were similar, whereas the odds of overall control (no hospitalisation or oral steroids for asthma, no antibiotics for lower respiratory infection, limited reliever use) were greater for extrafine ICS in both countries (UK odds ratio, 1.23; 95% confidence interval (CI), 1.01-1.50). Asthma-related annual costs, adjusted for baseline, were significantly lower for extrafine-particle ICS cohorts in both countries (UK difference, -£66 (95% CI,-93 to -37)). Cost-effectiveness analyses using the two measures of asthma control found 92 and 98% probabilities of extrafine-particle ICS being the preferred treatment strategy (less costly and more effective than standard size-particle ICS) in the UK, and 84 and 100% probabilities in the US., Conclusions: Initiating ICS therapy for asthma as extrafine-particle ICS seems the dominant treatment option (less costly and more effective) compared with standard size-particle ICS in both the UK and the US.

This research examined the prevalence of morning symptoms and their relationship with health status, exacerbations and daily activity in patients with chronic obstructive pulmonary disease (COPD). Data on 1489 patients were analysed from a European and USA sample. Results were tested for significance (p < 0.05) using Mann-Whitney and regression modelling accounting for age, gender, body mass index, comorbidities, symptom severity, smoking status and medication adherence. Morning symptoms were experienced by 39.8% of patients. Controlling for potential confounders, morning symptoms were significantly associated with higher COPD assessment test scores (p < 0.001) and exacerbation frequency (p < 0.001), more frequent worsening of symptoms without consulting a Health Care Professional (p = 0.008), and increased impact on normal daily activities (p = 0.007); and in the working population, a significantly greater impact on getting up and ready for the day (p < 0.001) and significantly more days off work per year (p < 0.001). Our research concluded that in patients with COPD, morning symptoms are associated with poorer health status, impaired daily activities and increased risk of exacerbation in affected patients compared with those patients without morning symptoms. Improved control of patients' morning symptoms may lead to substantial reduction in COPD impact and frequency of exacerbations, and enable patients to increase daily activities, particularly early morning activities. This could, in turn, enable working patients with COPD to be more productive in the workplace.