Publications by authors named "Eric Bateman"

182 Publications

Improving lung health in low-income and middle-income countries: from challenges to solutions.

Lancet 2021 Mar 22;397(10277):928-940. Epub 2021 Feb 22.

Global Asthma Network (GAN), Auckland, New Zealand; International Union Against Tuberculosis and Lung Diseases, Paris, France; Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia; UNSW Medicine, Sydney, NSW, Australia.

Low-income and middle-income countries (LMICs) bear a disproportionately high burden of the global morbidity and mortality caused by chronic respiratory diseases (CRDs), including asthma, chronic obstructive pulmonary disease, bronchiectasis, and post-tuberculosis lung disease. CRDs are strongly associated with poverty, infectious diseases, and other non-communicable diseases (NCDs), and contribute to complex multi-morbidity, with major consequences for the lives and livelihoods of those affected. The relevance of CRDs to health and socioeconomic wellbeing is expected to increase in the decades ahead, as life expectancies rise and the competing risks of early childhood mortality and infectious diseases plateau. As such, the World Health Organization has identified the prevention and control of NCDs as an urgent development issue and essential to the achievement of the Sustainable Development Goals by 2030. In this Review, we focus on CRDs in LMICs. We discuss the early life origins of CRDs; challenges in their prevention, diagnosis, and management in LMICs; and pathways to solutions to achieve true universal health coverage.
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http://dx.doi.org/10.1016/S0140-6736(21)00458-XDOI Listing
March 2021

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies.

Drug Saf 2021 Apr 6;44(4):467-478. Epub 2021 Feb 6.

Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.

Introduction: Budesonide-formoterol taken as needed is an emerging treatment for mild asthma.

Objective: We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide.

Methods: SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. Patients were randomized to As-needed budesonide-formoterol 200/6 μg, twice-daily budesonide 200 μg as maintenance plus As-needed terbutaline 0.5 mg, and As-needed terbutaline 0.5 mg (SYGMA 1 only). Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations from corresponding treatment groups in both studies were pooled. SYGMA 1 data were used for comparisons with As-needed terbutaline alone.

Results: The pooled analysis included 3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively. Common AEs included viral upper respiratory tract infection (viral URTI) and URTI. SAE, DAE, and asthma-related discontinuation rates were similar with As-needed budesonide-formoterol and maintenance budesonide. Potential local and systemic corticosteroid class effects were reported in ≤ 1% of patients for each budesonide-containing regimen. In SYGMA 1, AEs were more common in the As-needed terbutaline (n = 1277) than As-needed budesonide-formoterol (n = 1277) groups (42.7 vs. 38.0%), as were DAEs (2.9 vs. 0.8%) and asthma-related discontinuations (1.6 vs. 0.3%).

Conclusions: Budesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile similar to that of daily budesonide. No new safety signals were identified. CLINICALTRIAL.

Gov Identifiers: NCT02149199 (SYGMA 1) and NCT02224157 (SYGMA 2).
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http://dx.doi.org/10.1007/s40264-020-01041-zDOI Listing
April 2021

Addressing the quality of paediatric primary care: health worker and caregiver perspectives from a process evaluation of PACK child, a health systems intervention in South Africa.

BMC Pediatr 2021 Jan 28;21(1):58. Epub 2021 Jan 28.

Knowledge Translation Unit, University of Cape Town Lung Institute, George Street, Observatory, Cape Town, Western Cape, 7925, South Africa.

Background: The WHO's Integrated Management of Childhood Illness (IMCI) has resulted in progress in addressing infant and child mortality. However, unmet needs of children continue to present a burden upon primary healthcare services. The capacity of services and quality of care offered require greater support to address these needs by extending and integrating curative and preventive care for the child with a long-term health condition and the child older than 5, not prioritised in IMCI. In response to these needs, the PACK Child intervention was developed and piloted in October 2017-February 2019 in the Western Cape Province of South Africa. We report health worker and caregiver perspectives of the existing paediatric primary care context as well as the extent to which PACK Child functions to address perceived problems within the current local healthcare system.

Methods: This process evaluation involved 52 individual interviews with caregivers, 10 focus group discussions with health workers, 3 individual interviews with trainers, and 31 training observations. Interviews and focus groups explored participants' experiences of paediatric primary care, perspectives of the PACK Child intervention, and tensions with implementation in each context. Inductive thematic analysis was used to analyse verbatim interview and discussion transcripts.

Results: Perspectives of caregivers and health workers suggest an institutionalised focus of paediatric primary care to treating children's symptoms as acute episodic conditions. Health workers' reports imply that this focus is perpetuated by interactions between contextual features such as, IMCI policy, documentation-driven consultations, overcrowded clinics and verticalised care. Whilst these contextual conditions constrained health workers' ability to translate skills developed within PACK Child training into practice, the intervention initiated expanded care of children 0-13 years and those with long-term health conditions, enhanced professional competence, improved teamwork and referrals, streamlined triaging, and facilitated probing for psychosocial risk.

Conclusion: PACK Child appears to be catalysing paediatric primary care to address the broader needs of children, including long-term health conditions and the identification of psychosocial problems. However, to maximise this requires primary care to re-orientate from risk minimisation on the day of attendance towards a view of the child beyond the day of presentation at clinics.
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http://dx.doi.org/10.1186/s12887-021-02512-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7842050PMC
January 2021

Prevalence and Population Attributable Risk for Chronic Airflow Obstruction in a Large Multinational Study.

Am J Respir Crit Care Med 2020 Nov 10. Epub 2020 Nov 10.

Oregon Health Sciences University, Medicine / Pulmonary & Critical Care, Portland, Oregon, United States.

The Global Burden of Disease programme identified smoking, and ambient and household air pollution as the main drivers of death and disability from Chronic Obstructive Pulmonary Disease (COPD). To estimate the attributable risk of chronic airflow obstruction (CAO), a quantifiable characteristic of COPD, due to several risk factors. The Burden of Obstructive Lung Disease study is a cross-sectional study of adults, aged≥40, in a globally distributed sample of 41 urban and rural sites. Based on data from 28,459 participants, we estimated the prevalence of CAO, defined as a post-bronchodilator one-second forced expiratory volume to forced vital capacity ratio < lower limit of normal, and the relative risks associated with different risk factors. Local RR were estimated using a Bayesian hierarchical model borrowing information from across sites. From these RR and the prevalence of risk factors, we estimated local Population Attributable Risks (PAR). Mean prevalence of CAO was 11.2% in men and 8.6% in women. Mean PAR for smoking was 5.1% in men and 2.2% in women. The next most influential risk factors were poor education levels, working in a dusty job for ≥10 years, low body mass index (BMI), and a history of tuberculosis. The risk of CAO attributable to the different risk factors varied across sites. While smoking remains the most important risk factor for CAO, in some areas poor education, low BMI and passive smoking are of greater importance. Dusty occupations and tuberculosis are important risk factors at some sites.
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http://dx.doi.org/10.1164/rccm.202005-1990OCDOI Listing
November 2020

Effect of a single day of increased as-needed budesonide-formoterol use on short-term risk of severe exacerbations in patients with mild asthma: a post-hoc analysis of the SYGMA 1 study.

Lancet Respir Med 2021 02 1;9(2):149-158. Epub 2020 Oct 1.

Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.

Background: In mild asthma, as-needed budesonide-formoterol reduces long-term exacerbation risk compared with as-needed short-acting β-agonist (SABA), with a similar or increased reduction versus maintenance with budesonide plus as-needed SABA, despite a lower budesonide dose. In this post-hoc analysis of the SYmbicort Given as needed in Mild Asthma (SYGMA) 1 study, we investigated the short-term risk of severe exacerbations after a single day with various levels of reliever use.

Methods: SYGMA 1 was a 52-week, double-blind, randomised, controlled, phase 3 trial, in which patients aged 12 years or older with mild asthma were randomly assigned (1:1:1) to placebo twice daily plus as-needed terbutaline 0·5 mg, placebo twice daily plus as-needed budesonide-formoterol 200-6 μg, or budesonide 200 μg twice daily plus as-needed terbutaline (ie, budesonide maintenance group). In this post-hoc analysis, we assessed the frequency of reliever use and the risk of a severe exacerbation in the 21 days after first use of more than two, four, six, or eight reliever inhalations in 24 h. SYGMA 1 is registered with ClinicalTrials.gov, NCT02149199, and is now complete.

Findings: Of 5721 patients enrolled in SYGMA 1, 3849 were randomly assigned to as-needed terbutaline (n=1280), as-needed budesonide-formoterol (n=1279), or budesonide maintenance (n=1290), of whom 3836 had evaluable data (n=1277 as-needed terbutaline, n=1277 as needed budesonide-formoterol, and n=1282 budesonide maintenance). Median reliever use was 0·32 (IQR 0·08-0·91) inhalations per day for the as-needed terbutaline group, 0·29 (0·07-0·72) for the as-needed budesonide-formoterol group, and 0·16 (0·04-0·52) for the budesonide maintenance group. Compared with as-needed terbutaline, after adjustment for age, sex, randomly assigned treatment, pre-study treatment group, baseline % predicted post-bronchodilator FEV, and severe exacerbation in the 12 months before enrolment in the study, the hazard ratio (HR) for severe exacerbation in the 21 days after a single day with more than two as-needed inhalations was 0·27 (95% CI 0·12-0·58; p=0·0008) with as-needed budesonide-formoterol and 0·39 (0·19-0·79; p=0·0091) with budesonide maintenance; after a single day of more than four as-needed inhalations the HR was 0·24 (0·10-0·62; p=0·0030) with as-needed budesonide-formoterol and 0·30 (0·13-0·72; p=0·0065) with budesonide maintenance; and after a single day of more than six as-needed inhalations the HR was 0·14 (0·02-1·06; p=0·057) with as-needed budesonide-formoterol and 0·43 (0·14-1·26; p=0·12) with budesonide maintenance. HRs were not calculated for more than eight as-needed inhalations due to the small number of events.

Interpretation: In mild asthma, as-needed budesonide-formoterol reduces the short-term risk of severe exacerbations after a single day of higher use (more than two as-needed inhalations), even when overall use is infrequent. Use of an anti-inflammatory reliever might reduce the risk of short-term severe exacerbations by the timely provision of increased doses of as-needed inhaled corticosteroids and formoterol when symptoms occur. These findings should be further assessed in prospective randomised clinical trials.

Funding: AstraZeneca.
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http://dx.doi.org/10.1016/S2213-2600(20)30416-1DOI Listing
February 2021

ARIA-EAACI statement on asthma and COVID-19 (June 2, 2020).

Authors:
Jean Bousquet Marek Jutel Cezmi A Akdis Ludger Klimek Oliver Pfaar Kari C Nadeau Thomas Eiwegger Anna Bedbrook Ignacio J Ansotegui Josep M Anto Claus Bachert Eric D Bateman Kazi S Bennoor Elena Camelia Berghea Karl-Christian Bergmann Hubert Blain Mateo Bonini Sinthia Bosnic-Anticevich Louis-Philippe Boulet Luisa Brussino Roland Buhl Paulo Camargos Giorgio Walter Canonica Victoria Cardona Thomas Casale Sharon Chinthrajah Mübeccel Akdis Tomas Chivato George Christoff Alvaro A Cruz Wienczyslawa Czarlewski Stefano Del Giacco Hui Du Yehia El-Gamal Wytske J Fokkens Joao A Fonseca Yadong Gao Mina Gaga Bilun Gemicioglu Maia Gotua Tari Haahtela David Halpin Eckard Hamelmann Karin Hoffmann-Sommergruber Marc Humbert Nataliya Ilina Juan-Carlos Ivancevich Guy Joos Musa Khaitov Bruce Kirenga Edward F Knol Fanny W Ko Seppo Koskinen Marek L Kowalski Helga Kraxner Dmitry Kudlay Piotr Kuna Maciej Kupczyk Violeta Kvedariene Amir H Abdul Latiff Lan T Le Michael Levin Desiree Larenas-Linnemann Renaud Louis Mohammad R Masjedi Erik Melén Florin Mihaltan Branislava Milenkovic Yousser Mohammad Mario Morais-Almeida Joaquim Mullol Leyla Namazova Hugo Neffen Elisabete Nunes Paul O'Byrne Robyn O'Hehir Liam O'Mahony Ken Ohta Yoshitaka Okamoto Gabrielle L Onorato Petr Panzner Nikos G Papadopoulos Gianni Passalacqua Vincenzo Patella Ruby Pawankar Nhân Pham-Thi Bernard Pigearias Todor A Popov Francesca Puggioni Frederico S Regateiro Giovanni Rolla Menachem Rottem Boleslaw Samolinski Joaquin Sastre Jurgen Schwarze Aziz Sheikh Nicola Scichilone Manuel Soto-Quiros Manuel Soto-Martinez Milan Sova Stefania Nicola Rafael Stelmach Charlotte Suppli-Ulrik Luis Taborda-Barata Teresa To Peter-Valentin Tomazic Sanna Toppila-Salmi Ioanna Tsiligianni Omar Usmani Arunas Valiulis Maria Teresa Ventura Giovanni Viegi Theodor Vontetsianos De Yun Wang Sian Williams Gary W K Wong Arzu Yorgancioglu Mario Zernotti Mihaela Zidarn Torsten Zuberbier Ioana Agache

Allergy 2021 03 21;76(3):689-697. Epub 2020 Sep 21.

Transylvania University Brasov, Brasov, Romania.

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http://dx.doi.org/10.1111/all.14471DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361514PMC
March 2021

Transition from Restrictive to Obstructive Lung Function Impairment During Treatment and Follow-Up of Active Tuberculosis.

Int J Chron Obstruct Pulmon Dis 2020 11;15:1039-1047. Epub 2020 May 11.

University of Cape Town Lung Institute, and Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.

Background: Pulmonary tuberculosis (PTB) is associated with many forms of chronic lung disease including the development of chronic airflow obstruction (AFO). However, the nature, evolution and mechanisms responsible for the AFO after PTB are poorly understood. The aim of this study was to examine the progression of changes in lung physiology in patients treated for PTB.

Methods: Immunocompetent, previously healthy, adult patients receiving ambulatory treatment for a first episode of tuberculosis were prospectively followed up with serial lung physiology and quantitative computed tomography (CT) lung scans performed at diagnosis of tuberculosis, 2, 6, 12 and 18 months during and after the completion of treatment.

Results: Forty-nine patients (median age 26 years; 37.2% males) were included, and 43 were studied. During treatment, lung volumes improved and CT fibrosis scores decreased, but features of AFO and gas trapping emerged, while reduced diffusing capacity (DLco) seen in a majority of patients persisted. Significant increases in total lung capacity (TLC) by plethysmography were seen in the year following treatment completion (median change 5.9% pred., P<0.01) and were driven by large increases in residual volume (RV) (median change +19%pred., P<0.01) but not inspiratory capacity (IC; P=0.41). The change in RV/TLC correlated with significant progression of radiological gas trapping after treatment (P=0.04) but not with emphysema scores. One year after completing treatment, 18.6% of patients had residual restriction (total lung capacity, TLC <80%pred), 16.3% had AFO, 32.6% had gas trapping (RV/TLC>45%), and 78.6% had reduced DLco.

Conclusion: Simple spirometry alone does not fully reveal the residual respiratory impairments resulting after a first episode of PTB. Changes in physiology evolve after treatment completion, and these findings when taken together, suggest emergence of gas trapping after treatment likely caused by progression of small airway pathology during the healing process.
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http://dx.doi.org/10.2147/COPD.S219731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227812PMC
May 2020

Addressing the quality and scope of paediatric primary care in South Africa: evaluating contextual impacts of the introduction of the Practical Approach to Care Kit for children (PACK Child).

BMC Health Serv Res 2020 May 29;20(1):479. Epub 2020 May 29.

Knowledge Translation Unit, University of Cape Town Lung Institute, University of Cape Town, Mowbray, 7700, South Africa.

Background: Despite significant reductions in mortality, preventable and treatable conditions remain leading causes of death and illness in children in South Africa. The PACK Child intervention, comprising clinical decision support tool (guide), training strategy and health systems strengthening components, was developed to expand on WHO's Integrated Management of Childhood Illness programme, extending care of children under 5 years to those aged 0-13 years, those with chronic conditions needing regular follow-up, integration of curative and preventive measures and routine care of the well child. In 2017-2018, PACK Child was piloted in 10 primary healthcare facilities in the Western Cape Province. Here we report findings from an investigation into the contextual features of South African primary care that shaped how clinicians delivered the PACK Child intervention within clinical consultations.

Methods: Process evaluation using linguistic ethnographic methodology which provides analytical tools for investigating human behaviour, and the shifting meaning of talk and text within context. Methods included semi-structured interviews, focus groups, ethnographic observation, audio-recorded consultations and documentary analysis. Analysis focused on how mapped contextual features structured clinician-caregiver interactions.

Results: Primary healthcare facilities demonstrated an institutionalised orientation to minimising risk upheld by provincial documentation, providing curative episodic care to children presenting with acute symptoms, and preventive care including immunisations, feeding and growth monitoring, all in children 5 years or younger. Children with chronic illnesses such as asthma rarely receive routine care. These contextual features constrained the ability of clinicians to use the PACK Child guide to facilitate diagnosis of long-term conditions, elicit and manage psychosocial issues, and navigate use of the guide alongside provincial documentation.

Conclusion: Our findings provide evidence that PACK Child is catalysing a transition to an approach that strikes a balance between assessing and minimising risk on the day of acute presentation and a larger remit of care for children over time. However, optimising success of the intervention requires reviewing priorities for paediatric care which will facilitate enhanced skills, knowledge and deployment of clinical staff to better address acute illnesses and long-term health conditions of children of all ages, as well as complex psychosocial issues surrounding the child.
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http://dx.doi.org/10.1186/s12913-020-05201-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7257217PMC
May 2020

What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?

Respirology 2020 08 31;25(8):804-815. Epub 2020 Mar 31.

Michael G DeGroote School of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.

Despite improvements in medications, devices and understanding of the disease, about half of all asthma patients worldwide remain inadequately controlled, suggesting the need for a new approach to asthma management. Poor adherence to prescribed maintenance therapy and over-reliance on SABA reliever medication is a common cause of inadequate control. This article reviews published data from 6- to 12-month, double-blind, RCT and open-label real-world studies involving budesonide/formoterol maintenance and reliever therapy (MART) and relevant comparator approaches to asthma management, and considers how these compare in achieving the treatment goals described in guidelines. The data confirm that patients with asthma treated with budesonide/formoterol MART achieved the same or better asthma symptom control compared with ICS/LABA plus SABA regimens at similar or higher ICS doses, with consistently lower rates of exacerbations and considerably lower annual requirement for oral corticosteroids. These findings have been confirmed across a range of severities of persistent asthma. With the MART approach, maintenance dosing ensures coverage for day-to-day control, and the use of a reliever with anti-inflammatory properties (budesonide/formoterol) provides extra doses of ICS as soon as symptoms prompt the use of reliever, resulting in a 40-50% reduction of exacerbations compared with an ICS-based treatment approach plus as-needed SABA as reliever. As-needed, budesonide/formoterol has also recently been shown to be more effective as a reliever in mild asthma than SABA alone, reducing exacerbations by up to 64% in the SYGMA studies.
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http://dx.doi.org/10.1111/resp.13804DOI Listing
August 2020

Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianópolis, Brazil.

BMJ Glob Health 2019 16;4(6):e001921. Epub 2019 Dec 16.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, Western Cape, South Africa.

Introduction: The Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it.

Methods: Twenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates.

Results: Asthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms.

Conclusion: PACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates.

Trial Registration: NCT02786030 (https://clinicaltrials.gov/).
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http://dx.doi.org/10.1136/bmjgh-2019-001921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936566PMC
December 2019

Helsinki by nature: The Nature Step to Respiratory Health.

Clin Transl Allergy 2019 30;9:57. Epub 2019 Oct 30.

29FILHA, Finnish Lung Health Association, Helsinki, Finland.

Background: was the overarching theme of the 12th General Meeting of the Global Alliance against Chronic Respiratory Diseases (GARD) in Helsinki, August 2018. New approaches are needed to improve respiratory health and reduce premature mortality of chronic diseases by 30% till 2030 (UN Sustainable Development Goals, SDGs). Planetary health is defined as the health of human civilization and the state of the natural systems on which it depends. Planetary health and human health are interconnected, and both need to be considered by individuals and governments while addressing several SDGs.

Results: The concept of the Nature Step has evolved from innovative research indicating, how changed lifestyle in urban surroundings reduces contact with biodiverse environments, impoverishes microbiota, affects immune regulation and increases risk of NCDs. The Nature Step calls for strengthening connections to nature. Physical activity in natural environments should be promoted, use of fresh vegetables, fruits and water increased, and consumption of sugary drinks, tobacco and alcohol restricted. Nature relatedness should be part of everyday life and especially emphasized in the care of children and the elderly. Taking "nature" to modern cities in a controlled way is possible but a challenge for urban planning, nature conservation, housing, traffic arrangements, energy production, and importantly for supplying and distributing food. Actions against the well-known respiratory risk factors, air pollution and smoking, should be taken simultaneously.

Conclusions: In Finland and elsewhere in Europe, successful programmes have been implemented to reduce the burden of respiratory disorders and other NCDs. Unhealthy behaviour can be changed by well-coordinated actions involving all stakeholders. The growing public health concern caused by NCDs in urban surroundings cannot be solved by health care alone; a multidisciplinary approach is mandatory.
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http://dx.doi.org/10.1186/s13601-019-0295-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6822361PMC
October 2019

Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases.

Authors:
J Jean Bousquet Holger J Schünemann Alkis Togias Marina Erhola Peter W Hellings Torsten Zuberbier Ioana Agache Ignacio J Ansotegui Josep M Anto Claus Bachert Sven Becker Martin Bedolla-Barajas Michael Bewick Sinthia Bosnic-Anticevich Isabelle Bosse Louis P Boulet Jean Marc Bourrez Guy Brusselle Niels Chavannes Elisio Costa Alvaro A Cruz Wienczyslawa Czarlewski Wytske J Fokkens Joao A Fonseca Mina Gaga Tari Haahtela Maddalena Illario Ludger Klimek Piotr Kuna Violeta Kvedariene L T T Le Desiree Larenas-Linnemann Daniel Laune Olga M Lourenço Enrica Menditto Joaquin Mullol Yashitaka Okamoto Nikos Papadopoulos Nhân Pham-Thi Robert Picard Hilary Pinnock Nicolas Roche Regina E Roller-Wirnsberger Christine Rolland Boleslaw Samolinski Aziz Sheikh Sanna Toppila-Salmi Ioanna Tsiligianni Arunas Valiulis Erkka Valovirta Tuula Vasankari Maria-Teresa Ventura Samantha Walker Sian Williams Cezmi A Akdis Isabella Annesi-Maesano Sylvie Arnavielhe Xavier Basagana Eric Bateman Anna Bedbrook K S Bennoor Samuel Benveniste Karl C Bergmann Slawomir Bialek Nils Billo Carsten Bindslev-Jensen Leif Bjermer Hubert Blain Mateo Bonini Philippe Bonniaud Jacques Bouchard Vitalis Briedis Christofer E Brightling Jan Brozek Roland Buhl Roland Buonaiuto Giorgo W Canonica Victoria Cardona Ana M Carriazo Warner Carr Christine Cartier Thomas Casale Lorenzo Cecchi Alfonso M Cepeda Sarabia Eka Chkhartishvili Derek K Chu Cemal Cingi Elaine Colgan Jaime Correia de Sousa Anne Lise Courbis Adnan Custovic Biljana Cvetkosvki Gennaro D'Amato Jane da Silva Carina Dantas Dejand Dokic Yves Dauvilliers Antoni Dedeu Giulia De Feo Philippe Devillier Stefania Di Capua Marc Dykewickz Ruta Dubakiene Motohiro Ebisawa Yaya El-Gamal Esben Eller Regina Emuzyte John Farrell Antjie Fink-Wagner Alessandro Fiocchi Jean F Fontaine Bilun Gemicioğlu Peter Schmid-Grendelmeir Amiran Gamkrelidze Judith Garcia-Aymerich Maximiliano Gomez Sandra González Diaz Maia Gotua Nick A Guldemond Maria-Antonieta Guzmán Jawad Hajjam John O'B Hourihane Marc Humbert Guido Iaccarino Despo Ierodiakonou Maddalena Illario Juan C Ivancevich Guy Joos Ki-Suck Jung Marek Jutel Igor Kaidashev Omer Kalayci Przemyslaw Kardas Thomas Keil Mussa Khaitov Nikolai Khaltaev Jorg Kleine-Tebbe Marek L Kowalski Vicky Kritikos Inger Kull Lisa Leonardini Philip Lieberman Brian Lipworth Karin C Lodrup Carlsen Claudia C Loureiro Renaud Louis Alpana Mair Gert Marien Bassam Mahboub Joao Malva Patrick Manning Esteban De Manuel Keenoy Gailen D Marshall Mohamed R Masjedi Jorge F Maspero Eve Mathieu-Dupas Poalo M Matricardi Eric Melén Elisabete Melo-Gomes Eli O Meltzer Enrica Menditto Jacques Mercier Neven Miculinic Florin Mihaltan Branislava Milenkovic Giuliana Moda Maria-Dolores Mogica-Martinez Yousser Mohammad Steve Montefort Ricardo Monti Mario Morais-Almeida Ralf Mösges Lars Münter Antonella Muraro Ruth Murray Robert Naclerio Luigi Napoli Leila Namazova-Baranova Hugo Neffen Kristoff Nekam Angelo Neou Enrico Novellino Dieudonné Nyembue Robin O'Hehir Ken Ohta Kimi Okubo Gabrielle Onorato Solange Ouedraogo Isabella Pali-Schöll Susanna Palkonen Peter Panzner Hae-Sim Park Jean-Louis Pépin Ana-Maria Pereira Oliver Pfaar Ema Paulino Jim Phillips Robert Picard Davor Plavec Ted A Popov Fabienne Portejoie David Price Emmanuel P Prokopakis Benoit Pugin Filip Raciborski Rojin Rajabian-Söderlund Sietze Reitsma Xavier Rodo Antonino Romano Nelson Rosario Menahenm Rottem Dermot Ryan Johanna Salimäki Mario M Sanchez-Borges Juan-Carlos Sisul Dirceu Solé David Somekh Talant Sooronbaev Milan Sova Otto Spranger Cristina Stellato Rafael Stelmach Charlotte Suppli Ulrik Michel Thibaudon Teresa To Ana Todo-Bom Peter V Tomazic Antonio A Valero Rudolph Valenta Marylin Valentin-Rostan Rianne van der Kleij Olivier Vandenplas Giorgio Vezzani Frédéric Viart Giovanni Viegi Dana Wallace Martin Wagenmann De Y Wang Susan Waserman Magnus Wickman Dennis M Williams Gary Wong Piotr Wroczynski Panayiotis K Yiallouros Arzu Yorgancioglu Osman M Yusuf Heahter J Zar Stéphane Zeng Mario Zernotti Luo Zhang Nan S Zhong Mihaela Zidarn

Clin Transl Allergy 2019 9;9:44. Epub 2019 Sep 9.

260University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Background: In all societies, the burden and cost of allergic and chronic respiratory diseases are increasing rapidly. Most economies are struggling to deliver modern health care effectively. There is a need to support the transformation of the health care system into integrated care with organizational health literacy.

Main Body: As an example for chronic disease care, MASK (Mobile Airways Sentinel NetworK), a new project of the ARIA (Allergic Rhinitis and its Impact on Asthma) initiative, and POLLAR (Impact of Air POLLution on Asthma and Rhinitis, EIT Health), in collaboration with professional and patient organizations in the field of allergy and airway diseases, are proposing real-life ICPs centred around the patient with rhinitis, and using mHealth to monitor environmental exposure. Three aspects of care pathways are being developed: (i) Patient participation, health literacy and self-care through technology-assisted "patient activation", (ii) Implementation of care pathways by pharmacists and (iii) Next-generation guidelines assessing the recommendations of GRADE guidelines in rhinitis and asthma using real-world evidence (RWE) obtained through mobile technology. The EU and global political agendas are of great importance in supporting the digital transformation of health and care, and MASK has been recognized by DG Santé as a Good Practice in the field of digitally-enabled, integrated, person-centred care.

Conclusion: In 20 years, ARIA has considerably evolved from the first multimorbidity guideline in respiratory diseases to the digital transformation of health and care with a strong political involvement.
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http://dx.doi.org/10.1186/s13601-019-0279-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734297PMC
September 2019

The Global Initiative for Asthma (GINA): 25 years later.

Eur Respir J 2019 08 29;54(2). Epub 2019 Aug 29.

Firestone Institute of Respiratory Health, St Joseph's Healthcare, McMaster University, Hamilton, ON, Canada.

The Global Initiative for Asthma (GINA) was launched in 1993 under the auspices of the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization to produce a global strategy on asthma management and prevention. Now constituted as a non-profit entity, it continues to produce, on an annual basis, the most widely cited evidence-based report on the optimal management of asthma in both adults and children intended for global use. Although the GINA Report is often viewed and used as an asthma treatment guideline, it is designed to be a clinically oriented strategy document that supports the development of practice guidelines in different countries and regions.Other GINA products, including the report's pocket guides, teaching slide kits and implementation tools, are also offered free of charge for public use. The GINA Scientific Committee comprises recognised international experts from primary, secondary and tertiary centres of care who are actively involved in both the care of patients and research in asthma. The GINA Assembly is a forum for exchange of scientific information and discussions on initiatives to improve asthma care in various countries, focusing on implementation strategies. GINA plays a role in shaping research on the diagnosis and treatment of asthma and informs the development of point of care practice guides and decision support tools. GINA supports the objectives of raising awareness of asthma and improving access to therapy and quality of care for asthmatic patients, in addition to presenting and promoting continuously updated evidence-based treatment approaches for global use.
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http://dx.doi.org/10.1183/13993003.00598-2019DOI Listing
August 2019

Prevalence and Characteristics of Asthma-Chronic Obstructive Pulmonary Disease Overlap in Routine Primary Care Practices.

Ann Am Thorac Soc 2019 09;16(9):1143-1150

Pneumologie et Soins Intensifs Respiratoires, Groupe Hospitalier Cochin, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Paris, France.

Adults may exhibit characteristics of both asthma and chronic obstructive pulmonary disease (COPD), a situation recently described as asthma-COPD overlap (ACO). There is a paucity of information about ACO in primary care. To estimate the prevalence and describe characteristics of individuals with ACO in primary care practices among patients currently diagnosed with asthma, COPD, or both; and to compare the prevalence and characteristics of ACO among the three source populations. The Respiratory Effectiveness Group conducted a cross-sectional study of individuals ≥40 years old and with ≥2 outpatient primary care visits over a 2-year period in the UK Optimum Patient Care Research Database. Patients were classified into one of three source populations based on diagnostic codes: ) COPD only, ) both asthma and COPD, or ) asthma only. ACO was defined as the presence of all of the following ) age ≥40 years, ) current or former smoking, 3) post-bronchodilator airflow limitation (forced expiratory volume in 1 second/forced vital capacity <0.7), and ) ≥12% and ≥200 ml reversibility in post-bronchodilator forced expiratory volume in 1 second. Among 2,165 individuals (1,015 COPD only, 395 with both asthma and COPD, and 755 asthma only), the overall prevalence of ACO was 20% (95% confidence interval, 18-23%). Patients with ACO had a mean age of 70 years (standard deviation, 11 yr), 60% were men, 73% were former smokers (the rest were current smokers), and 66% were overweight or obese. Comorbid conditions were common in patients with ACO, including diabetes (53%), cardiovascular disease (36%), hypertension (30%), eczema (23%), and rhinitis (21%). The prevalence of ACO was higher in patients with a diagnosis of both asthma and COPD (32%) compared with a diagnosis of COPD only (20%;  < 0.001) or asthma only (14%;  < 0.001). Demographic and clinical characteristics of ACO varied across these three source populations. One in five individuals with a diagnosis of COPD, asthma, or both asthma and COPD in primary care settings have ACO based on the Respiratory Effectiveness Group ACO Working group criteria. The prevalence and characteristics of patients with ACO varies across the three source populations.
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http://dx.doi.org/10.1513/AnnalsATS.201809-607OCDOI Listing
September 2019

Global Initiative for Asthma 2016-derived asthma control with fluticasone propionate and salmeterol: A Gaining Optimal Asthma Control (GOAL) study reanalysis.

Ann Allergy Asthma Immunol 2019 07 24;123(1):57-63.e2. Epub 2019 Apr 24.

Global Respiratory Franchise, GSK House, Brentford, Middlesex, United Kingdom.

Background: In 2004, the landmark Gaining Optimal Asthma Control (GOAL) study demonstrated that most patients can achieve asthma control through sustained treatment and that adding a long-acting β-adrenoreceptor agonist to an inhaled corticosteroid (ICS) is more effective than ICS alone in this regard. Definitions of asthma control have since evolved, and the consequent implications for the GOAL study findings are unclear.

Objective: To evaluate the efficacy of fluticasone propionate and salmeterol and fluticasone propionate alone in achieving and maintaining asthma control, as derived from the Global Initiative for Asthma (GINA) 2016 report.

Methods: In total, 3416 patients were stratified by prior medication (ICS-naive [stratum 1], low-dose ICS [stratum 2], or medium-dose ICS [stratum 3]) and randomized to receive fluticasone propionate and salmeterol or fluticasone propionate. The primary end point was the proportion of patients achieving well-controlled or partly controlled asthma; secondary end points included the proportion of patients achieving well-controlled asthma. Control was evaluated during the last 4 weeks of each dose titration.

Results: In all strata, more patients achieved well-controlled or partly controlled asthma with fluticasone propionate and salmeterol vs fluticasone propionate alone (stratum 1: 91% vs 85%; P = .003; stratum 2: 86% vs 82%; P = .07; and stratum 3: 76% vs 66%; P < .001), as well as patients with well-controlled asthma (stratum 1: 64% vs 56%; P = .005; stratum 2: 59% vs 41%; P < .001; and stratum 3: 40% vs 22%; P < .001).

Conclusion: A markedly higher proportion of patients with uncontrolled asthma in each stratum achieved control according to GINA 2016 criteria compared with the original study criteria. The proportion of patients achieving control remained greater with fluticasone propionate and salmeterol than with fluticasone propionate alone.
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http://dx.doi.org/10.1016/j.anai.2019.04.018DOI Listing
July 2019

e-PC101: an electronic clinical decision support tool developed in South Africa for primary care in low-income and middle-income countries.

BMJ Glob Health 2018 20;3(Suppl 5):e001093. Epub 2019 Feb 20.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

Health technology is increasingly recognised as a feasible method of addressing health needs in low and middle-income countries (LMICs). Primary Care 101, now known as PACK (Practical Approach to Care Kit), is a printed, algorithmic, checklist-based, comprehensive clinical decision support tool. It assists clinicians with delivering evidence-based medicine for common primary care presentations and conditions. These assessment and treatment guides have been adopted widely in primary care clinics across South Africa. This paper focuses on the process of designing, developing, and implementing a digital version of the clinical decision support tool for use on a tablet computer. Lessons learnt throughout its development and pilot implementation could apply to the creation of electronic health interventions and the digitisation of clinical tools in LMICs.
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http://dx.doi.org/10.1136/bmjgh-2018-001093DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407554PMC
February 2019

Randomized dose-finding study of batefenterol via dry powder inhaler in patients with COPD.

Int J Chron Obstruct Pulmon Dis 2019;14:615-629. Epub 2019 Mar 8.

GSK, Research and Development, Collegeville, PA, USA.

Background: Batefenterol is a novel bifunctional muscarinic antagonist β-agonist in development for COPD. The primary objective of this randomized, double-blind, placebo-controlled, active comparator, Phase IIb study was to model the dose-response of batefenterol and select a dose for Phase III development.

Patients And Methods: Patients aged ≥40 years with COPD and FEV ≥30% and ≤70% predicted normal were randomized equally to batefenterol 37.5, 75, 150, 300, or 600 µg, placebo, or umeclidinium/vilanterol (UMEC/VI) 62.5/25 µg once daily. The primary and secondary endpoints were weighted-mean FEV over 0-6 hours post-dose and trough FEV, analyzed by Bayesian and maximum likelihood estimation E of dose-response modeling, respectively, on day 42.

Results: In the intent-to-treat population (N=323), all batefenterol doses demonstrated statistically and clinically significant improvements from baseline vs placebo in the primary and secondary endpoints (191.1-292.8 and 182.2-244.8 mL, respectively), with a relatively flat dose-response. In the subgroup reversible to salbutamol, there were greater differences between batefenterol doses. Lung function improvements with batefenterol ≥150 µg were comparable with those with UMEC/VI. Batefenterol was well tolerated and no new safety signals were observed.

Conclusion: Batefenterol 300 µg may represent the optimal dose for Phase III studies.
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http://dx.doi.org/10.2147/COPD.S190603DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413745PMC
July 2019

Overdiagnosis of COPD in Subjects With Unobstructed Spirometry: A BOLD Analysis.

Chest 2019 08 31;156(2):277-288. Epub 2019 Jan 31.

Respiratory Epidemiology and Public Health Group, Imperial College, London, London, United Kingdom.

Background: There are several reports on underdiagnosis of COPD, while little is known about COPD overdiagnosis and overtreatment. We describe the overdiagnosis and the prevalence of spirometrically defined false positive COPD, as well as their relationship with overtreatment across 23 population samples in 20 countries participating in the BOLD Study between 2003 and 2012.

Methods: A false positive diagnosis of COPD was considered when participants reported a doctor's diagnosis of COPD, but postbronchodilator spirometry was unobstructed (FEV/FVC > LLN). Additional analyses were performed using the fixed ratio criterion (FEV/FVC < 0.7).

Results: Among 16,177 participants, 919 (5.7%) reported a previous medical diagnosis of COPD. Postbronchodilator spirometry was unobstructed in 569 subjects (61.9%): false positive COPD. A similar rate of overdiagnosis was seen when using the fixed ratio criterion (55.3%). In a subgroup analysis excluding participants who reported a diagnosis of "chronic bronchitis" or "emphysema" (n = 220), 37.7% had no airflow limitation. The site-specific prevalence of false positive COPD varied greatly, from 1.9% in low- to middle-income countries to 4.9% in high-income countries. In multivariate analysis, overdiagnosis was more common among women, and was associated with higher education; former and current smoking; the presence of wheeze, cough, and phlegm; and concomitant medical diagnosis of asthma or heart disease. Among the subjects with false positive COPD, 45.7% reported current use of respiratory medication. Excluding patients with reported asthma, 34.4% of those with normal spirometry still used a respiratory medication.

Conclusions: False positive COPD is frequent. This might expose nonobstructed subjects to possible adverse effects of respiratory medication.
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http://dx.doi.org/10.1016/j.chest.2019.01.015DOI Listing
August 2019

Empowering frontline providers to deliver universal primary healthcare using the Practical and Approach to care kit.

BMJ Glob Health 2018 19;3(Suppl 5). Epub 2018 Nov 19.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

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http://dx.doi.org/10.1136/bmjgh-2018-k4451repDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6266967PMC
November 2018

Crossing borders: the PACK experience of spreading a complex health system intervention across low-income and middle-income countries.

BMJ Glob Health 2018 26;3(Suppl 5):e001088. Epub 2018 Oct 26.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

Developing a health system intervention that helps to improve primary care in a low-income and middle-income country (LMIC) is a considerable challenge; finding ways to spread that intervention to other LMICs is another. The Practical Approach to Care Kit (PACK) programme is a complex health system intervention that has been developed and adopted as policy in South Africa to improve and standardise primary care delivery. We have successfully spread PACK to several other LMICs, including Botswana, Brazil, Nigeria and Ethiopia. This paper describes our experiences of localising and implementing PACK in these countries, and our evolving mentorship model of localisation that entails our unit providing mentorship support to an in-country team to ensure that the programme is tailored to local resource constraints, burden of disease and on-the-ground realities. The iterative nature of the model's development meant that with each country experience, we could refine both the mentorship package and the programme itself with lessons from one country applied to the next-a 'learning health system' with global reach. While not yet formally evaluated, we appear to have created a feasible model for taking our health system intervention across more borders.
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http://dx.doi.org/10.1136/bmjgh-2018-001088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231097PMC
October 2018

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Brazil.

BMJ Glob Health 2018 25;3(Suppl 5):e001016. Epub 2018 Oct 25.

Pulmonary Division - Heart Institute (iCor), University of São Paulo Medical School, Sao Paulo, Brazil.

Brazil's Sistema Único de Saúde, or Unified Health System policy, has delivered major improvements in health coverage and outcomes, but challenges remain, including the rise of non-communicable diseases (NCDs) and variations in quality of care across the country. Some of these challenges may be met through the adaptation and implementation of a South African primary care strategy, the Practical Approach to Care Kit (PACK). Developed by the University of Cape Town's Knowledge Translation Unit (KTU), PACK is intended for in-country adaptation by employing a mentorship model. Using this approach, the PACK Adult guide and training materials were localised for use in Florianópolis, Santa Catarina, Brazil, as part of an initiative to reform primary care, expand care for NCDs and make services more accessible and equitable. The value of the collaboration between the KTU and Florianópolis municipality is the transfer of skills and avoidance of duplication of effort involved in de-novo guide development, while ensuring that materials are locally acceptable and applicable. The collaboration has informed the development of the KTU's PACK mentorship package and led to a relationship between the groups of developers, ensuring ongoing learning and research, with the potential of assisting the further scale-up of PACK in Brazil.
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http://dx.doi.org/10.1136/bmjgh-2018-001016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231100PMC
October 2018

Using a mentorship model to localise the Practical Approach to Care Kit (PACK): from South Africa to Nigeria.

BMJ Glob Health 2018 23;3(Suppl 5):e001079. Epub 2018 Oct 23.

Health Resources International West Africa, Calabar, Nigeria.

Nigeria, in its quest to strengthen its primary healthcare system, is faced with a number of challenges including a shortage of clinicians and skills. Methods are being sought to better equip primary healthcare clinicians for the clinical demands that they face. Using a mentorship model between developers in South Africa and Nigerian clinicians, the Practical Approach to Care Kit (PACK) for adult patients, a health systems strengthening programme, has been localised and piloted in 51 primary healthcare facilities in three Nigerian states. Lessons learnt from this experience include the value of this remote model of localisation for rapid localisation, the importance of early, continuous stakeholder engagement, the need expressed by Nigeria's primary healthcare clinicians for clinical guidance that is user friendly and up-to-date, a preference for the tablet version of the PACK Adult guide over hard copies and the added value of WhatsApp groups to complement the programme of face-to-face continuous learning. Introduction of the PACK programme in Nigeria prompted uptake of evidence-informed recommendations within primary healthcare services.
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http://dx.doi.org/10.1136/bmjgh-2018-001079DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6202991PMC
October 2018

PACK Child: the development of a practical guide to extend the scope of integrated primary care for children and young adolescents.

BMJ Glob Health 2018 23;3(Suppl 5):e000957. Epub 2018 Oct 23.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

Pioneering strategies like WHO's Integrated Management of Childhood Illness (IMCI) have resulted in substantial progress in addressing infant and child mortality. However, large inequalities exist in access to and the quality of care provided in different regions of the world. In many low-income and middle-income countries, childhood mortality remains a major concern, and the needs of children present a large burden upon primary care services. The capacity of services and quality of care offered require greater support to address these needs and extend integrated curative and preventive care, specifically, for the well child, the child with a long-term health need and the child older than 5 years, not currently included in IMCI. In response to these needs, we have developed an innovative method, based on experience with a similar approach in adults, that expands the scope and reach of integrated management and training programmes for paediatric primary care. This paper describes the development and key features of the PACK Child clinical decision support tool for the care of children up to 13 years, and lessons learnt during its development.
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http://dx.doi.org/10.1136/bmjgh-2018-000957DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203049PMC
October 2018

Strengthening the quality of paediatric primary care: protocol for the process evaluation of a health systems intervention in South Africa.

BMJ Glob Health 2018 23;3(Suppl 5):e000945. Epub 2018 Oct 23.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

Background: Despite significant reductions in mortality, preventable and treatable conditions remain the leading causes of death in children under five within South Africa. The WHO's Integrated Management of Childhood Illness (IMCI) programme has been widely implemented to address the most common causes of mortality in children under five. Although effective, limitations in IMCI scope and adherence have emerged. The Practical Approach to Care Kit (PACK) Child guide has been developed to expand on IMCI and address these limitations. It is intended as a clinical decision support tool for health workers with additional systems strengthening components, including active implementation and training strategy to address contextual and organisational factors hindering quality of care for children. Implementation is complex, requiring comprehensive pilot and process evaluation. The PACK Child pilot and feasibility study will sample 10 primary care facilities in the Western Cape Province. Staff will be trained to integrate the PACK Child guide into routine practice. The process evaluation will investigate implementation and health systems components to establish how to optimise delivery, strengthen IMCI principles and factors required to support effective and sustained uptake into everyday practice.

Methods: Mixed method process evaluation. Qualitative data include interviews with managers, staff, caregivers and policymakers; observations of training, consultations and clinic flow. Quantitative data include training logs and staff questionnaires. Quantitative and qualitative analysis will be integrated to describe study sites and develop explanations for implementation variation.

Discussion: The process evaluation will provide the opportunity to document implementation and refine the programme prior to a larger pragmatic trial or scale-up.
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http://dx.doi.org/10.1136/bmjgh-2018-000945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203013PMC
October 2018

The Practical Approach to Care Kit (PACK) guide: developing a clinical decision support tool to simplify, standardise and strengthen primary healthcare delivery.

BMJ Glob Health 2018 17;3(Suppl 5):e000962. Epub 2018 Oct 17.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

For the primary health worker in a low/middle-income country (LMIC) setting, delivering quality primary care is challenging. This is often complicated by clinical guidance that is out of date, inconsistent and informed by evidence from high-income countries that ignores LMIC resource constraints and burden of disease. The Knowledge Translation Unit (KTU) of the University of Cape Town Lung Institute has developed, implemented and evaluated a health systems intervention in South Africa, and localised it to Botswana, Nigeria, Ethiopia and Brazil, that simplifies and standardises the care delivered by primary health workers while strengthening the system in which they work. At the core of this intervention, called Practical Approach to Care Kit (PACK), is a clinical decision support tool, the PACK guide. This paper describes the development of the guide over an 18-year period and explains the design features that have addressed what the patient, the clinician and the health system need from clinical guidance, and have made it, in the words of a South African primary care nurse, 'A tool for every day for every patient'. It describes the lessons learnt during the development process that the KTU now applies to further development, maintenance and in-country localisation of the guide: develop clinical decision support in context first, involve local stakeholders in all stages, leverage others' evidence databases to remain up to date and ensure content development, updating and localisation articulate with implementation.
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http://dx.doi.org/10.1136/bmjgh-2018-000962DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6195147PMC
October 2018

Empowering frontline providers to deliver universal primary healthcare using the Practical Approach to Care Kit.

BMJ 2018 Oct 24;363:k4451. Epub 2018 Oct 24.

Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6200083PMC
http://dx.doi.org/10.1136/bmj.k4451DOI Listing
October 2018

Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma.

Am J Respir Crit Care Med 2019 02;199(4):489-495

6 Johannes Gutenberg University Mainz, Mainz, Germany.

Rationale: Reslizumab is a humanized anti-IL-5 monoclonal antibody used as add-on maintenance treatment for patients with uncontrolled eosinophilic asthma.

Objectives: To predict response and nonresponse to intravenous reslizumab at 52 weeks with an algorithm we developed based on clinical indicators from pivotal clinical trials.

Methods: Patients aged 18 years and older who met Global Initiative for Asthma 4 or 5 criteria and received intravenous reslizumab (n = 321) in two trials ( www.clinicaltrials.gov identifiers, NCT01287039 and NCT01285323) were selected as the data source. A mathematical model was constructed that was based on change from baseline to 16 weeks in Asthma Control Questionnaire and Asthma Quality of Life Questionnaire scores and FEV, and number of clinical asthma exacerbations during the year before enrollment and in the first 16 weeks of treatment, and these measures were evaluated for their ability to predict the outcome at 52 weeks: responder, nonresponder, or indeterminate.

Measurements And Main Results: The algorithm predicted that 276 patients would be classified as responders; in 248 (89.9%), the prediction was correct. In comparison, 26 patients were predicted to be nonresponders; 50.0% of these predictions were correct. Nineteen patients were classified as indeterminate. The algorithm had 95.4-95.5% sensitivity and 40.6-54.1% specificity. Jackknife and cross-study validation confirmed the robustness of the algorithm.

Conclusions: Our algorithm enabled prediction at 16 weeks of treatment of the response to intravenous reslizumab treatment at 52 weeks, but it was not suitable for predicting nonresponse. A positive score at 16 weeks should encourage continued treatment, and a negative score should prompt close monitoring to determine whether discontinuation is warranted.
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http://dx.doi.org/10.1164/rccm.201708-1668OCDOI Listing
February 2019

Allergic Rhinitis and its Impact on Asthma (ARIA) Phase 4 (2018): Change management in allergic rhinitis and asthma multimorbidity using mobile technology.

Authors:
Jean Bousquet Peter W Hellings Ioana Agache Flore Amat Isabella Annesi-Maesano Ignacio J Ansotegui Josep M Anto Claus Bachert Eric D Bateman Anna Bedbrook Kazi Bennoor Mickael Bewick Carsten Bindslev-Jensen Sinthia Bosnic-Anticevich Isabelle Bosse Jan Brozek Luisa Brussino Giorgio W Canonica Victoria Cardona Thomas Casale Alfonso M Cepeda Sarabia Niels H Chavannes Lorenzo Cecchi Jaime Correia de Sousa Elisio Costa Alvaro A Cruz Wienczyslawa Czarlewski Giuseppe De Carlo Giulia De Feo Pascal Demoly Philippe Devillier Mark S Dykewicz Yehia El-Gamal Esben E Eller Joao A Fonseca Jean-François Fontaine Wytske J Fokkens Maria-Antonieta Guzmán Tari Haahtela Maddalena Illario Juan-Carlos Ivancevich Jocelyne Just Igor Kaidashev Musa Khaitov Omer Kalayci Thomas Keil Ludger Klimek Marek L Kowalski Piotr Kuna Violeta Kvedariene Desiree Larenas-Linnemann Daniel Laune Lan T T Le Karin Lodrup Carlsen Olga Lourenço Bassam Mahboub Alpana Mair Enrica Menditto Branislava Milenkovic Mario Morais-Almeida Ralph Mösges Joaquim Mullol Ruth Murray Robert Naclerio Leyla Namazova-Baranova Ettore Novellino Robyn E O'Hehir Ken Ohta Yoshitaka Okamoto Kimi Okubo Gabrielle L Onorato Susanna Palkonen Petr Panzner Nikos G Papadopoulos Hae-Sim Park Ema Paulino Ruby Pawankar Oliver Pfaar Davor Plavec Ted A Popov Paul Potter Emmanuel P Prokopakis Menachem Rottem Dermot Ryan Johanna Salimäki Boleslaw Samolinski Mario Sanchez-Borges Holger J Schunemann Aziz Sheikh Juan-Carlos Sisul Rojin Rajabian-Söderlund Talant Sooronbaev Cristiana Stellato Teresa To Ana-Maria Todo-Bom Peter-Valentin Tomazic Sanna Toppila-Salmi Antonio Valero Arunas Valiulis Erkka Valovirta Maria-Teresa Ventura Martin Wagenmann De Yun Wang Dana Wallace Susan Waserman Magnus Wickman Arzu Yorgancioglu Luo Zhang Nanshan Zhong Mihaela Zidarn Torsten Zuberbier

J Allergy Clin Immunol 2019 03 29;143(3):864-879. Epub 2018 Sep 29.

Comprehensive Allergy Center Charité, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, and Global Allergy and Asthma European Network (GA2LEN), Berlin, Germany.

Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline by using the best approach to integrated care pathways using mobile technology in patients with allergic rhinitis (AR) and asthma multimorbidity. The proposed next phase of ARIA is change management, with the aim of providing an active and healthy life to patients with rhinitis and to those with asthma multimorbidity across the lifecycle irrespective of their sex or socioeconomic status to reduce health and social inequities incurred by the disease. ARIA has followed the 8-step model of Kotter to assess and implement the effect of rhinitis on asthma multimorbidity and to propose multimorbid guidelines. A second change management strategy is proposed by ARIA Phase 4 to increase self-medication and shared decision making in rhinitis and asthma multimorbidity. An innovation of ARIA has been the development and validation of information technology evidence-based tools (Mobile Airways Sentinel Network [MASK]) that can inform patient decisions on the basis of a self-care plan proposed by the health care professional.
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http://dx.doi.org/10.1016/j.jaci.2018.08.049DOI Listing
March 2019