Mark L Levy

An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice

BACKGROUND The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. PURPOSE The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. METHODS A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. RESULTS The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. CONCLUSIONS The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

British guideline on the management of asthma: A national clinical guideline

These guidelines have been replaced by British Guideline on the Management of Asthma. A national clinical guideline. Superseded By 2012 Revision Of 2008 Guideline: British Guideline on the Management of Asthma. Thorax 2008 May; 63(Suppl 4): 1–121.

BTS guidelines for the management of community acquired pneumonia in adults: update 2009

A summary of the initial management of patients admitted to hospital with suspected community acquired pneumonia (CAP) is presented in fig 8. Tables 4 and 5, respectively, summarise (1) the relevant microbiological investigations and (2) empirical antibiotic choices recommended in patients with CAP. Figure 8 Hospital management of community acquired pneumonia (CAP) in the first 4 h. CXR, chest x ray; DBP, diastolic blood pressure; SBP, systolic blood pressure. View this table: Table 4 Recommendations for the microbiological investigation of community acquired pneumonia (CAP) View this table: Table 5 Initial empirical treatment regimens for community acquired pneumonia (CAP) in adults ### Investigations ( Section 5 ) #### When should a chest radiograph be performed in the community? 1. It is not necessary to perform a chest radiograph in patients with suspected CAP unless: 2. #### When should a chest radiograph be performed in hospital? 1. All patients admitted to hospital with suspected CAP should have a chest radiograph performed as soon as possible to confirm or refute the diagnosis. [D] The objective of any service should be for the chest radiograph to be performed in time for antibiotics to be administered within 4 h of presentation to hospital should the diagnosis of CAP be confirmed. #### When should the chest radiograph be repeated during recovery? 1. The chest radiograph need not be repeated prior to hospital discharge in those who have made a satisfactory clinical recovery from CAP. [D] 2. A chest radiograph should be arranged after about 6 weeks for all those patients who have persistence of symptoms or physical signs or who are at higher risk of underlying malignancy (especially smokers and those aged >50 years) whether or not they have been admitted to hospital. [D] 3. Further investigations which may include bronchoscopy should be considered in patients with persisting signs, symptoms …

A new perspective on concepts of asthma severity and control

Concepts of asthma severity and control are important in the evaluation of patients and their response to treatment but the terminology is not standardised and the terms are often used interchangeably. This review, arising from the work of an American Thoracic Society/European Respiratory Society Task Force, identifies the need for separate concepts of control and severity, describes their evolution in asthma guidelines and provides a framework for understanding the relationship between current concepts of asthma phenotype, severity and control. “Asthma control” refers to the extent to which the manifestations of asthma have been reduced or removed by treatment. Its assessment should incorporate the dual components of current clinical control (e.g. symptoms, reliever use and lung function) and future risk (e.g. exacerbations and lung function decline). The most clinically useful concept of asthma severity is based on the intensity of treatment required to achieve good asthma control, i.e. severity is assessed during treatment. Severe asthma is defined as the requirement for (not necessarily just prescription or use of) high-intensity treatment. Asthma severity may be influenced by the underlying disease activity and by the patients phenotype, both of which may be further described using pathological and physiological markers. These markers can also act as surrogate measures for future risk.

A summary of the new GINA strategy: a roadmap to asthma control

Over the past 20 years, the Global Initiative for Asthma (GINA) has regularly published and annually updated a global strategy for asthma management and prevention that has formed the basis for many national guidelines. However, uptake of existing guidelines is poor. A major revision of the GINA report was published in 2014, and updated in 2015, reflecting an evolving understanding of heterogeneous airways disease, a broader evidence base, increasing interest in targeted treatment, and evidence about effective implementation approaches. During development of the report, the clinical utility of recommendations and strategies for their practical implementation were considered in parallel with the scientific evidence. This article provides a summary of key changes in the GINA report, and their rationale. The changes include a revised asthma definition; tools for assessing symptom control and risk factors for adverse outcomes; expanded indications for inhaled corticosteroid therapy; a framework for targeted treatment based on phenotype, modifiable risk factors, patient preference, and practical issues; optimisation of medication effectiveness by addressing inhaler technique and adherence; revised recommendations about written asthma action plans; diagnosis and initial treatment of the asthma−chronic obstructive pulmonary disease overlap syndrome; diagnosis in wheezing pre-school children; and updated strategies for adaptation and implementation of GINA recommendations. This paper summarises key changes in the GINA global strategy report, a practical new resource for asthma care http://ow.ly/ObvYi

Symptom-based questionnaire for identifying COPD in smokers

Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD) screening in primary care. Objectives: We prospectively tested questions to help identify COPD among smokers without prior history of lung disease. Methods: Subjects were recruited via random mailing to primary care practices in Aberdeen, UK, and Denver, Colo., USA. Current and former smokers aged 40 or older with no prior respiratory diagnosis and no respiratory medications in the past year were enrolled. Participants answered questions covering demographics and symptoms and then underwent spirometry with reversibility testing. A study diagnosis of COPD was defined as fixed airway obstruction as measured by postbronchodilator FEV1/FVC <0.70. We examined the ability of individual questions in a multivariate framework to correctly discriminate between persons with and without COPD. Results: 818 subjects completed all investigations and proceeded to analysis. The list of 54 questions yielded 52 items for analysis, which was reduced to 17 items for entry into multivariate regression. Eight items had significant relationships with the study diagnosis of COPD, including age, pack-years, body mass index, weather-affected cough, phlegm without a cold, morning phlegm, wheeze frequency, and history of any allergies. Individual items yielded odds ratios ranging from 0.23 to 12. This questionnaire demonstrated a sensitivity of 80.4 and specificity of 72.0. Conclusions: A simple patient self-administered questionnaire can be used to identify patients with a high likelihood of having COPD, for whom spirometric testing is particularly important. Implementation of this questionnaire could enhance the efficiency and diagnostic accuracy of current screening efforts.

Diagnostic spirometry in primary care: Proposed standards for general practice compliant with American Thoracic Society and European Respiratory Society recommendations: a General Practice Airways Group (GPIAG)1 document, in association with the Association for Respiratory Technology & Physiology (ARTP)2 and Education for Health3 1 www.gpiag.org 2 www.artp.org 3 www.educationforhealth.org.uk.

Primary care spirometry services can be provided by trained primary care staff, peripatetic specialist services, or through referral to hospital-based or laboratory spirometry. The first of these options is the focus of this Standards Document. It aims to provide detailed information for clinicians, managers and healthcare commissioners on the key areas of quality required for diagnostic spirometry in primary care--including training requirements and quality assurance. These proposals and recommendations are designed to raise the standard of spirometry and respiratory diagnosis in primary care and to provide the impetus for debate, improvement and maintenance of quality for diagnostic (rather than screening) spirometry performed in primary care. This document should therefore challenge current performance and should constitute an aspirational guide for delivery of this service.

Ethnic variations in UK asthma frequency, morbidity, and health-service use: a systematic review and meta-analysis

BACKGROUND The frequency of asthma varies between countries, and may also vary between ethnic groups in more geographically confined areas. We sought evidence of such ethnic variations in the UK for asthma frequency, morbidity, and health-services use, and to understand possible reasons for any differences. METHODS We searched MEDLINE, EMBASE, CINAHL, PSYCHInfo, PREMEDLINE, HEALTHSTAR, Cambridge Register of Conference Abstracts, the Dissertation and Thesis Database, and the National Registry of Research. Additionally, we searched the bibliographies of reports identified and websites of health authorities, and contacted experts in this discipline. Our main outcomes were comparisons of asthma rate, morbidity, and health-services use. We did meta-analyses using random-effects models. FINDINGS 13 studies contained relevant data. All prevalence studies were of children and showed that south Asian children had a lower frequency of symptoms suggestive of asthma compared with black and white children (pooled rate of history of wheeze in the previous 12 months: south Asians 9.6% [95%CI 8.0-11.2%], black people 16.2% [12.8-19.6%], white people 14.6% [11.5-17.8%]). The pooled frequency of clinician-diagnosed asthma in children followed a similar pattern (south Asians 7.6% [3.7-11.4%], black people 15.0% [3.5-26.5%], white people 10.6% [4.6-16.7%]. However, relative to white people, the risk of admission for asthma in children and adults was higher for south Asians (odds ratio 2.9 [2.4-3.4]) and black people (2.1 [1.8-2.5]). INTERPRETATION The differences in admission are not explained by differences in asthma frequency between groups; they could relate to ethnic variations in asthma severity, differences in health-seeking behaviour, or difficulties in accessing high-quality primary care services.

The ADMIT series — Issues in Inhalation Therapy. 2) Improving technique and clinical effectiveness

Aerosol inhalation is considered the optimal route for administering the majority of drugs for the treatment of obstructive airways diseases. A number of Pressurised Metered-Dose and Dry Powder Inhalers are available for this purpose. However, inhalation of therapeutic aerosols is not without difficulty; it requires precise instructions on the inhalation manoeuvre, which is different from spontaneous normal breathing. Also, the characteristics of the inhaler device have to be suitable for the user. Available data indicate a frequent lack of knowledge demonstrated by health professionals and patients on the inhalation manoeuvre and handling of inhalers, resulting in a reduction of therapeutic benefit. This paper reviews the literature concerning the fundamental aspects of inhaler devices, inhalation manoeuvre and device selection, in an attempt to increase the knowledge of, and to optimise the clinical use of, therapeutic inhalers.

A guide to the translation of the Global Initiative for Asthma (GINA) strategy into improved care

In 1995, the Global Initiative for Asthma (GINA) published an evidence-based workshop report as a guide to clinicians managing asthma patients, and has updated it annually to ensure that recommendations remain current. Although the report has been widely disseminated and influenced clinical practice and research, its major objective, of forming the basis for local and national initiatives to improve services for asthma patients, remains to be achieved. Over recent years, the science of guideline implementation has progressed, and encouraging examples of successful asthma programmes have been published. This report is intended to draw on this experience and assist with the translation of asthma guideline recommendations into quality programmes for patients with asthma using current knowledge translation principles. It also provides examples of successful initiatives in various socioeconomic settings.