journal canadien de thÉrapie respiratoire · the canadian journal of respiratory therapy is a...

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J O U R N A L C A N A D I E N D E T H É R A P I E R E S P I R A T O I R E

s p r i n g 2 0 1 4 • v o l u m e 5 0 • n u m b e r 1

message from the ed itor - in -ch ief / message du rédacteur en chef

Celebrating 50 years / 50 ans, c’est à célébrer

commentaries

Beyond the business case: How to make your idea a reality

How do we measure the quality of a respiratory therapy education program?

review

Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: Daily home spirometry versus standard pulmonary function testing

orig inal art icles

A retrospective analysis of airway managment in patients with obstructive sleep apnea and its effects on postanesthesia care unit length of stay

Complementary and alternative medicine: A survey of its use in children with chronic respiratory illness

PM 40062595

Official Journal of / Journal officiel de la

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1Can J Respir Ther Vol 50 No 1 Spring 2014

EDITOR-IN-CHIEFJason Nickerson, RRT, FCSRT, PhD Bruyère Research Institute, Ottawa, ON

MaNagINg EDITORCarly McCuaig, Ottawa, ON

EDITORIaL BOaRDAndrea White, Markham, RRT, CRE Professor, Respiratory Therapy, The Michener Institute, Toronto ONPeter J Papadakos, MD, FCCM Director, Critical Care Medicine Professor, Departments Anesthesiology, Surgery and Neurosurgery, University of Rochester, Rochester, NYKathy F Spurr BSc, RRT, MHI, FCSRT Assistant Professor, School of Health Sciences Dalhousie University, Halifax, NSNorman H Tiffin, BSc, MSA President, IPAC Consulting, London, ONAndrew West, MAppSc, RRT Assistant Professor and Head Department of Respiratory Therapy School of Medical Rehabilitation University of Manitoba, Winnipeg, MB

CaNaDIaN SOCIETY OF RESpIRaTORY THERapISTS

The Canadian Society of Respiratory Therapists provides national leader-ship through advocacy, service and unity to respiratory therapists in Canada. Established in 1964 as the Canadian Society of Inhalation Therapy Technicians, the CSRT is the national professional association that represents over 3500 respiratory therapists across Canada and pro-motes exemplary standards of practice, conduct and performance in the provision of respiratory care. The CSRT is also the credentialing body for RTs who practice in non-regulated jurisdictions and administers the accreditation process for respiratory therapy education programs. For more information, please visit: www.csrt.comCSRT EXECUTIVE DIRECTOR Christiane Ménard, OntarioPRESIDEnT Angela Coxe, OntarioPRESIDEnT-ElECT Jessie Cox, NewfoundlandTREaSURER Adam Buettner, Saskatchewan

BOaRD MEMBERSLouis Phillip Belle-Isle, QuébecChantale MacEwen, Prince

Edward IslandBarbara MacDonald, Nova Scotia

Susan Martin, OntarioDavid Sheets, British ColumbiaJeff Dionne, OntarioEdouard Saadé, New Brunswick

OFFICES

Canadian Society of Respiratory TherapistsAddress: CSRT, Suite 400 − 331 Cooper St, Ottawa, Ontario K2P 0G5

pUBLISHER’S OFFICE

Publisher Robert B KalinaVice-President Ann LeBlanc

EDITORIaL

Managing Editor Brian Vukusicassociate Editors Emily Hayes Sara Miller McCutcheon John WellerProduction Manager Lynne MumfordProduction artist Lindsay HermsenEditorial Coordinator Julie Pajuluoma

SaLES 905-829-4770

account Representative Diana Greiss ext 145

aDMINISTRaTION

Director of administration Andrea Holteradministrative assistant Julie Pajuluoma

IT DEpaRTMENT

Manager – Information Technology Deval Parikh Webmaster Stanley Chia

OFFICESPulsus Group Inc 2902 South Sheridan Way Oakville, Ontario, Canada L6J 7L6 Telephone 905-829-4770 Fax 905-829-4799 [email protected] www.pulsus.com



Publications Mail Agreement 40062595Return undeliverable Canadian addresses to:

Pulsus Group Inc, 2902 South Sheridan Way, Oakville, Ontario L6J 7L6

MaNUSCRIpT SUBMISSIONSUBMIT ONLINEGo to www.pulsus.com,

click on the Canadian Journal of Respiratory Therapy link,click on ‘Submit Manuscript’

and follow the instructions for ‘Online Submissions’

Full Instructions to Authors are available from the Publisher on the Internet at <www.pulsus.com/pdfs/instruct_resther.pdf>. Authors who require assistance are encouraged to telephone

1-866-829-4770 ext 141 or e-mail [email protected] for technical support.

CJRT is published four times per year (Spring, Summer, Fall and Winter).Annual subscriptions are included in annual membership to the CSRT. Subscription rate for 2014 for other individuals and institutions within Canada is $100, USA orders are USD$110 and others USD$120. All Canadian orders are subject to applicable taxes. Requests for subscriptions and changes of address: Membership, CSRT, Suite 400 − 331 Cooper Street, Ottawa, Ontario K2P 0G5.Once published, an article becomes the permanent property of the Canadian Journal of Respiratory Therapy and may not be published elsewhere, in whole or in part, without written permission from the Canadian Society of Respiratory Therapists. All editorial matter in CJRT represents the opinions of the authors and is not necessarily that of the CJRT, the editors, Editorial Board, the publisher of the journal or the CSRT. The CJRT assumes no responsibility or liability for damages arising from any error or omission from the use of any information or advice contained in the CJRT including editorials, articles, reports, book and video reviews, letters and advertisements.

gENERaL INFORMaTION

2Can J Respir Ther Vol 50 No 1 Spring 2014

RéDaCTEUR-EN-CHEFJason Nickerson, RRT, FCSRT, PhDInstitut recherche Bruyère, Ottawa, Ont. DIRECTRICE DE La REDaCTIONCarly McCuaig, Ottawa, Ont.

COMITé DE RéDaCTIONAndrea White Markham, RRT, CREMembre du corps professoral, Thérapie respiratoire,Coordinatrice de l’ERA, The Michener Institute, Toronto, Ont.

Peter J Papadakos, MD, FCCMDirecteur, Médecine des soins intensifsProfesseur, Départements d’anesthésiologie, de chirurgie et de neurochirurgie, Université de Rochester, Rochester, NY

Kathy F Spurr, BSc, RRT, MHI, FSCTRProfesseure adjointe, School of Health SciencesUniversité Dalhousie, Halifax, N.-É.

Norman H Tiffin, BSc, MSAPresident, IPAC Consulting, London, Ont.

Andrew West, MAppSc, RRTProfesseur adjoint et ChefDépartement de thérapie respiratoireÉcole de réadaptation médicaleUniversité du Manitoba, Winnipeg, Man.

SOCIéTé CaNaDIENNE DES THéRapEUTES RESpIRaTOIRES

DIRECTRICE gÉnÉRalE DE la SCTR Christiane Ménard, Ontario

PRÉSIDEnT Angela Coxe, Ontario

PRESIDEnT-ÉlU Jessie Cox, Terre-Neuve

TRÉSORIER Adam Buettner, Saskatchewan

MEMBRE DU CONSEIL

Louis Phillip Belle-Isle, QuébecChantale MacEwen, Île-du-Prince-Édouard

Barbara MacDonald, Nouvelle-ÉcosseSusan Martin, Ontario

David Sheets, Columbie-BritanniqueJeff Dionne, Ontario

Edouard Saadé, Nouveau-Brunswick

OFFICES

Société canadienne des thérapeutes respiratoires

Adresse: SCTR, Suite 400 − rue 331 Cooper, Ottawa ON K2P 0G5

pUBLISHER’S OFFICEPublisher Robert B KalinaVice-President Ann LeBlanc

EDITORIaL

Managing Editor Brian Vukusicassociate Editors Emily Hayes Sara Miller McCutcheon John WellerProduction Manager Lynne MumfordProduction artist Alex HarenEditorial Coordinator Julie Pajuluoma

SaLES 905-829-4770

account Representative Diana Greiss ext 145

aDMINISTRaTION

Director of administration Andrea Holteradministrative assistant Julie Pajuluoma

IT DEpaRTMENT

Manager – Information Technology Deval ParikhWebmaster Stanley Chia

OFFICESPulsus Group Inc2902 South Sheridan WayOakville, Ontario, Canada L6J 7L6Telephone 905-829-4770Fax [email protected]



Publications Mail Agreement 40062595Return undeliverable Canadian addresses to:

Pulsus Group Inc, 2902 South Sheridan Way, Oakville, Ontario L6J 7L6

MaNUSCRIpT SUBMISSIONSUBMIT ONLINEGo to www.pulsus.com,

click on the Canadian Journal of Respiratory Therapy link,click on ‘Submit Manuscript’

and follow the instructions for ‘Online Submissions’

Full Instructions to Authors are available from the Publisher on the Internet at <www.pulsus.com/pdfs/instruct_resther.pdf>. Authors who require assistance are encouraged to telephone

1-866-829-4770 ext 141 or e-mail [email protected] for technical support.

La JCRT paraît 4 fois l’an (en printemps, été, automne et hiver).L’abonnement annuel est compris dans la cotisation des membres de la SCTR. Le tarif annuel d’abonnement pour les non-membres et les établissements au Canada est de 100 $. Les commandes internationales sont 120 $ USD. La TVH de 13% est ajoutée aux commandes canadiennes.Veuillez faire parvenir les demandes d’abonnement et les changements d’adresse à l’adresse suivante: Centre des services aux membres, SCTR, Suite 400 − rue 331 Cooper, Ottawa ON K2P 0G5.Dès qu’un article est publié, il devient propriété permanente du Journal canadien de la thérapie respiratoire, et ne peut être publié ailleurs, en totalité ou en partie, sans la permission de la Société canadienne des thérapeutes respiratoires. Tous les articles à caractère éditorial dans le JCTR représentent les opinions de leurs auteurs et n’engagent ni le Journal canadien de la thérapie respiratoire, ni les rédacteurs ou l’éditeur de la revue, ni la SCTR. Le journal canadien de la thérapie respiratoire décline toute responsabilité civile ou autre quant à toute erreur ou omission, ou à l’usage de tout conseil ou information fi gurant dans le JCTR et les éditoriaux, articles, rapports, recensions de livres et de vidéos, lettres et publicités y paraissant.

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s p r i n g 2 0 1 4 • v o l u m e 5 0 • n u m b e r 1

MESSagE FROM THE EDITOR-IN-CHIEF / MESSagE DU RéDaCTEUR EN CHEF

Celebrating 50 years / 50 ans, c’est à célébrer 7

Jason NickersonCOMMENTaRIES

Beyond the business case: How to make your idea a reality 11

Kevin Taylor

How do we measure the quality of a respiratory therapy education program? 15Sandra Biesheuvel

review

Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: 17 Daily home spirometry versus standard pulmonary function testingKevin S Robson, Andrew J WestBronchiolitis obliterans syndrome (BOS) is a fibrotic inflammatory process that manifests in a significant number of lung transplant recipients within five years of transplant. Left unchecked, the disease process, which has been linked to almost all chronic rejections, leads to irreversible damage, progressing to long-term sequelae and, eventually, respiratory failure. This systematic review examined the outcomes of eight ran-domized controlled trials that fulfilled specific selection criteria to determine whether home spirometry could be used as a BOS detection tool.

ORIgINaL aRTICLES

a retrospective analysis of airway managment in patients with obstructive sleep apnea 23 and its effects on postanesthesia care unit length of stayClaire A Brousseau, Gregory R Dobson, Andrew D MilneThe development of obstructive sleep apnea (OSA), an increasingly prevalent condition in modern-day society and, especially, in the surgi-cal population, is contingent on several risk factors including pharyngeal anatomy, obesity and genetics, among others. Therefore, recogniz-ing OSA in perioperative settings and postdischarge planning is especially relevant. This study examined airway management techniques and difficulty of intubation in 91 adult surgical patients, the majority of whom had formally diagnosed OSA.

Complementary and alternative medicine: a survey of its use in children with chronic respiratory illness 27

Ellison Richmond, Denise Adams, Simon Dagenais, Tammy Clifford, Lola Baydala, W James King, Sunita VohraThe high prevalence of chronic illness has prompted many to seek treatment alternatives outside of conventional medicine. Many health care providers, however, may be dangerously unaware of CAM use in their patients due, in part, to nondisclosure or because CAM use is not specifically addressed in the clinic or office. Prompted by the lack of data from Canada, this study investigated pediatric CAM use in respi-ratory clinics in Edmonton (Alberta) and Ottawa (Ontario).

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Can J Respir Ther Vol 50 No 1 Spring 2014 7

Il y a 50 ans, ce qui deviendrait rapidement la profession de l’inhalothérapie voyait le

jour au sein de la Société canadienne des techniciens en radiologie. Un an plus tard, Canadian Inhalation Therapy publiait son premier numéro. Depuis la création de la profession, la recherche, l’évaluation et le transfert du savoir sont fondamentaux pour mieux com-prendre l’inhalothérapie et améliorer les soins aux patients.

Nous visons toujours les mêmes objectifs, soit de faire progresser les connaissances mondiales sur les interventions cliniques efficaces et les moyens d’améliorer les soins aux patients atteints de mal-adies respiratoires. En rétrospective, nous avons été précurseurs et avons cultivé les idées nova-trices, la recherche et les observations qui ont suscité des améliorations significatives au travail

des inhalothérapeutes et à l’intégration des services d’inhalothérapie au système de santé canadien. Nous avons de quoi être fiers de nombreuses réalisations, qui devraient nous inciter à continuer de chercher à atteindre les normes les plus élevées en recherche médicale, en innova-tion et en partage d’idées importantes.

Notre travail est loin d’être terminé. De plus en plus d’inhalothérapeutes font des études supérieures et de la recherche. Qui plus est, une population croissante d’inhalothérapeutes pose des ques-tions importantes sur ce que nous faisons, la façon dont nous le faisons et le contexte dans lequel nous fonctionnons. Le Journal permet l’exploration rigoureuse et systématique de chaque secteur et la présen-tation de nouvelles idées et observations à un groupe de cliniciens et d’esprits inquisiteurs. De bien des façons, le Journal vise à briser le statu quo. Pour aborder des sujets aussi vastes, il faut nécessairement une équipe éditoriale ouverte à de nouvelles idées, mais axée sur la qualité, généreuse dans ses indications éditoriales tout en étant protectrice de l’intégrité de la recherche publiée.

Sur un plan plus pratique, le Journal existe grâce aux efforts des auteurs qui font des travaux importants et soumettent leurs résultats ou leurs observations à la publication. Sans leur engagement, non seule-ment le Journal mettrait la clé sous la porte, mais la profession et la prestation de soins en santé respiratoire sécuritaires, compétents et efficaces ne pourraient évoluer.

Le Journal d’aujourd’hui est la culmination de tous ces volets. Les efforts de l’ensemble de la profession, du comité de rédaction et des collaborateurs contribuent de manière impressionnante et importante à la science et à l’exercice de l’inhalothérapie et de la médecine res-piratoire. Au cours des 50 prochaines années, nous devrions pour-suivre dans cette voie, et le congrès annuel à Montréal, au Québec, devrait en être le point de départ.

Chaque année, la qualité et la complexité des travaux présentés au congrès augmentent. Cet événement est une occasion unique de par-tager des idées et la genèse de nouveaux programmes et de modes de soins novateurs. Le salon des exposants, où sont présentés les progrès

Correspondence: Dr Jason Nickerson, Bruyère Research Institute, 308B – 85 Primrose Avenue, Ottawa, Ontario K1R 7G5. Telephone 613-562-6262, e-mail [email protected]

50 years ago, what would soon evolve to become the profession of respiratory therapy emerged as

the Canadian Society of Inhalation Therapy Technicians. One year following the inception of the Society, Canadian Inhalation Therapy published its first issue. From the outset of the profession, research, evaluation and knowledge translation have been fundamental to advancing our understanding of res-piratory therapy and improving the care that we provide to our patients.

Today, we continue to work toward these same goals of advancing a global understanding of effective clinical interventions and ways of improving care for patients with respiratory diseases. Looking back, we have pioneered and cultivated innovative ideas, research and commentary that have led to meaningful improvements in how respiratory therapists work and how respiratory therapy departments integrate them-selves into the Canadian health care system. There are many achieve-ments that we should be proud of, and these achievements should propel us to continue to pursue the highest standards of biomedical research and innovation and the sharing of important ideas.

Our work is far from over. There are a growing number of respiratory therapists pursuing advanced degrees and research opportunities and, most importantly, there is a growing population of respiratory therapists who are asking important questions of the things that we do, the ways in which we do them and the contexts in which we operate. The role of the Journal is to provide space for each of the areas to be explored rigor-ously and systematically, offering new ideas and new findings to a com-munity of clinicians and inquisitive minds. In many ways, the role of the Journal is to disrupt the status quo. Tackling such broad topics necessarily requires an editorial team that is open to new ideas, yet focused on qual-ity; one that is generous in their editorial insight, yet protective of the integrity of the research that we publish.

Most practically, the Journal exists because of the efforts of the auth-ors who conduct important work and submit their findings or their com-mentaries for publication. Without this commitment, not only would the Journal cease to exist, but so too would the advancement of the profession and important developments in the provision of safe, compe-tent and effective respiratory care.

The Journal that exists today is the culmination of all of these things. The efforts of the profession as a whole, the editorial board as a team, and the individual authors who contribute their works have culminated in an impressive and important contribution to the science and practice of respiratory therapy and respiratory medicine. The next 50 years should compel us to build on this foundation that has been laid, and the annual educational conference in Montreal (Quebec) should be the starting point.

Every year, the quality and the complexity of the work presented at the conference increases, and this event provides a unique opportunity for the sharing of ideas and the genesis of new programs and innovative ways of providing care. The most visible artefact of this is the trade show,

message from the editor-in-chief / message du rédacteur en chef

©2014 Canadian Society of Respiratory Therapists. All rights reserved

Dr Jason Nickerson

50 ans, c’est à célébrer

celebrating 50 years

Nickerson

Can J Respir Ther Vol 50 No 1 Spring 20148

where new developments in medical devices and pharmaceuticals are on display; however, the academic program highlights equally innovative contributions to the health care system. While the conference is an opportunity to connect and share, this needs to be the launching point for sharing these ideas with the world through the publication of pilot studies, case reports, health technology assessments, clinical trials, and important commentary on all of these and more. As with previous years, the Journal will publish the abstracts of the posters presented, but we do so not as a final product, but as an incentive for the authors to contrib-ute a full-length manuscript to share the intricacies of their work and their findings.

Beyond publishing research, the Journal needs to cultivate an environment that engages respiratory therapists in meaningful commen-tary on the profession, the science that underlies it, and the politics of health care delivery in Canada and around the world. There are import-ant critiques of the work that we publish that need to be heard, and aspects of health for which there has been too little exploration in our field. As the profession and the Journal continues to grow, we must devote greater attention to the social determinants of health, global health and fostering health equity to ensure that not only do we improve the quality of care we provide, but that we improve care in a way that is equitable, comprehensive, and to the benefit of all patients in Canada and around the world.

To achieve these and more, we need to continue to work to build the community of researchers and thoughtful clinicians that led the development of the initial Society and journal in Canada, and we must strive to find ways of engaging respiratory therapists in the profession. The Journal is designed to be open and independent, allowing for frank analysis and commentary on the profession, the state of research, and health care ethics and policy issues. Contributing to this discussion can be in the form of a detailed research project or a letter to the editor – we give appropriate weight to every submission that we receive and work hard to support the development of individual respiratory therapists and the science of the profession.

The next 50 years require continued growth and support from the community of Canadian and international respiratory therapists to ensure that we continue to play an important role in the care of patients with respiratory diseases. From the perspective of the Journal, this most importantly requires respiratory therapists to contribute to the discus-sion through the publication of important research and commentary. We are here to give you a voice and to encourage the development of individuals and the community. We look forward to what is to come.

Jason Nickerson RRT FCSRT PhDEditor-in-Chief

des instruments médicaux et des produits, en est le signe le plus évi-dent. Cependant, le programme scientifique fait aussi ressortir les innovations au système de santé. Le congrès permet de réseauter et de partager, mais doit permettre de lancer ces idées dans le monde grâce à la publication de projets pilotes, de rapports de cas, d’évaluations de technologies de santé, d’essais cliniques et d’observations importantes à tous ces égards et plus encore. Comme par les années passées, le Journal publiera les résumés des affiches présentées, non pas sous forme de produit final, mais pour inciter les auteurs à proposer des manuscrits intégraux pour partager les subtilités de leurs travaux et leurs observations.

En plus de publier des recherches, le Journal doit cultiver un environnement qui incite les inhalothérapeutes à faire des observations judicieuses sur la profession, la science sur laquelle elle repose et les poli-tiques de prestation des soins au Canada et dans le monde. Il faut faire entendre d’importantes critiques sur le travail que nous publions et pré-senter les aspects de la santé qui ont été trop peu explorés dans notre domaine. Tandis que la profession et le Journal continuent de prendre de l’expansion, nous devons insister davantage sur les déterminants sociaux de la santé, la santé mondiale et l’équité en santé pour amé-liorer la qualité des soins, et ce, d’une manière équitable et appro-fondie, au profit des patients du Canada et du reste du monde.

Pour réaliser cet objectif et plus encore, nous devons continuer de bâtir la communauté de chercheurs et de cliniciens réfléchis qui ont présidé à la création de la Société et du Journal au Canada, et chercher des moyens pour que les inhalothérapeutes s’investissent dans la pro-fession. Le Journal est conçu pour être ouvert et indépendant, permet-tre une analyse et un commentaire francs sur la profession, l’état de la recherche, l’éthique de la santé et les enjeux politiques. Il est possible d’y participer tout autant par un projet de recherche détaillé que par une lettre à l’éditeur. Nous accordons le poids voulu à chaque soumis-sion et nous efforçons de soutenir le perfectionnement de chaque inhalothérapeute et l’avancement de la science qui sous-tend notre profession.

Les 50 prochaines années doivent être sous l’égide de la croissance et du soutien de la part du milieu de l’inhalothérapie au Canada et dans le monde, afin que nous continuions de jouer un rôle important dans les soins aux patients atteints de maladies respiratoires. Du point de vue du Journal, il est essentiel que les inhalothérapeutes participent à la discussion en publiant des recherches et des observations importantes. Nous sommes là pour vous donner la parole et pour favoriser l’évolution des individus et de la communauté. Nous sommes impatients de voir ce que l’avenir nous réserve.

Jason Nickerson RRT FCSRT Ph. D.Rédacteur en chef

* ONBREZ and BREEZHALER are registered trademarks.Product Monograph available on request.Exp: 05/2014© Novartis Pharmaceuticals Canada Inc. 2013

Indication & clinical use:ONBREZ* BREEZHALER* (indacaterol maleate) is a long-acting ß2-agonist (LABA) indicated for long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. • Not indicated for the relief of acute deterioration of COPD, for asthma, or for use in patients under 18 years of age

Contraindications:• Not indicated for treatment of asthma

Most serious warnings and precautions:Asthma-related death: Increased risk of asthma-related death is considered a class effect with LABAs, including indacaterol maleate. ONBREZ* BREEZHALER* is not indicated for asthma.

Other relevant warnings and precautions:• Not indicated for acute episodes of bronchospasm• Increased risk of cardiovascular effects • Caution in patients with cardiovascular disorders• Caution in patients with convulsive disorders, thyrotoxicosis and patients who are unusually responsive to ß2-adrenergic agonists

• Risk of hypokalemia and hyperglycemia• Paradoxical bronchospasm• Immediate hypersensitivity• Should not be used in patients with acutely deteriorating COPD• Should not be used concomitantly with other LABAs• May inhibit labour

For more information:Please consult the Product Monograph at www.novartis.ca/asknovartispharma/download.htm?res=onbrez%20breezhaler_scrip_e.pdf&resTitleId=482 for important information relating to adverse events, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling the Medical Information department at 1-800-363-8883. FEV1: forced expiratory volume in 1 second; LS: least square; TDI: transition dyspnea index.† B2355: A 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group

study assessing the safety and efficacy of ONBREZ* BREEZHALER* 75 mcg once daily vs. placebo in patients with COPD (n=318).

‡ From a subset of 239 patients in B2355. FEV1 data shown is ONBREZ* BREEZHALER* vs. placebo, respectively: 5 min: 1.56 vs. 1.39; 30 min: 1.57 vs. 1.38; 1 hr: 1.56 vs. 1.38; 2 hrs: 1.56 vs. 1.37; 4 hrs: 1.51 vs. 1.35; 6 hrs: 1.48 vs. 1.33; 12 hrs: 1.43 vs. 1.29;16 hrs: 1.39 vs. 1.24; 22 hrs: 1.44 vs. 1.27; 24 hrs: 1.48 vs. 1.34.

§ B2354: A 12-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group study assessing the safety and efficacy of ONBREZ* BREEZHALER* 75 mcg once daily vs. placebo in patients with COPD (n=323).

¶ Comparative clinical significance has not been established.

Demonstrated fast, 5-minute onset (FEV1 improvementshown 5 minutes after first dose 0.1 L; p<0.001,serial FEV1 measurement)1†

Maintained round-the-clock (24-hour) bronchodilation(LS mean FEV1 (L) vs. placebo at week 12, p<0.001;time points were 5 min, 30 min, 1 hr, 2 hrs, 4 hrs,6 hrs, 12 hrs, 16 hrs, 22 hrs, and 24 hrs)1,2†‡

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References: 1. ONBREZ* BREEZHALER* Product Monograph. Novartis Pharmaceuticals Canada Inc., October 24, 2012. 2. Data on file. Novartis Pharmaceuticals Canada Inc. Study B2355. 3. Data on file. Novartis Pharmaceuticals Canada Inc. Study B2354.

ONBREZ* BREEZHALER* The only ONCE-DAILY LABA in COPD¶

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Beyond the business case: how to make your idea a reality

Kevin Taylor RRT MBA

College of Respiratory Therapists of Ontario, Toronto, OntarioCorrespondence: Mr Kevin Taylor, College of Respiratory Therapists of Ontario, 180 Dundas Street West, Suite 2103, Toronto,

Ontario M5G 1Z8. Telephone 416-591-7800 ext 21, fax 416-591-7890, e-mail [email protected]

Ever have a great idea? If you do and you want to translate that idea into reality, you’re inevitably going to have to convince someone

else to support that idea. Maybe you work in a hospital and you need the support of a manager or someone more senior in your organization. Maybe you need someone to give you the resources to support your initiative. In either case, a good idea rarely ‘sells itself ’. You typically have to present a business case or a convincing argument that gives the decision maker the information they need to make an informed choice... but even that is rarely enough. Every decision maker has their own range of factors to consider when reviewing your proposal, and understanding those factors will ultimately help you to build a better business case. It may even help you to address some of those considera-tions beforehand, making it easier for the decision maker to say ‘yes’. But you are not done yet. Even if your proposal is supported, you will still have to successfully implement your idea... and most decision makers will want to know how you intend to do that before they lend their support.

So while there is obviously much to consider when building your argument, you can approach it systematically. The model that follows breaks down the overall process into three steps: building the business case; paving the way; and winning the decision (Figure 1). The goal is to use all three to identify and address everything that could affect the success of your idea... and you can use this for tackling any decision, big or small. The steps intentionally overlap with one another – you will be discovering new information all the time, so be prepared to go back and revise.

STEP 1: BUIlD THE BUSInESS CaSEDeveloping your ideaA good place to start is to spell out exactly what it is that you are pro-posing. You will want to explain why your idea is needed, perhaps by providing a description of the current state. You will need to determine how much it will cost, in terms of both dollars and human resources; the timelines involved; and, if you have any codependencies (ie, are you doing this by yourself or does someone else have to do something as well?). Let’s hit that again... the financials matter. It does not hurt to get input or help from someone with experience when working through your idea, especially in this area (eg, your manager). Of

course, it is absolutely crucial that you can describe your idea in sim-ple, concise terms – think ‘elevator speech’. A decision maker wants to be clear on what he/she is agreeing to and the easier an idea is to understand, the easier it is to support.

articulating the benefitsNext, you will want to describe all the benefits that you can expect to realize, perhaps coupled with what will happen if you do not imple-ment your idea. You cannot assume that the decision maker knows what you know; therefore, try to identify what assumptions are embed-ded in your proposal and make them explicit. It is important to be honest and factual in this, regardless of how enthusiastic you are about your idea. Embellishing or diluting the facts with your own opinions will only serve to undermine the credibility of your idea. It is also important to put the benefits in the language of the decision maker. That perspective will be different than your own so do your home-work. Talk to people who have similar positions or even ask your deci-sion maker what they need to hear in your proposal. Better to get it right than to bring forward a proposal that does not cover the things that your decision maker is really concerned about.

Framing the ideaOnce you have your case well built, weave in elements that make it a compelling argument. For example, are you asking for something that has already been done successfully elsewhere? Precedents help strengthen your argument and speak to risk; therefore, they are defin-itely worth mentioning. Is there a higher principle that you can appeal to? Improving patient safety, for example, is much more compelling than a more humble goal. Finally, try to put your idea in perspective – will your idea improve safety for two patients or 2000? Essentially, if the primary beneficiary of your proposal is you, good luck...

STEP 2: PaVE THE WaYNow that you have a strong business case, you can start gathering additional information, consider other perspectives and build support to pave the way for a successful decision.

Understand how the decision is madeIt is important to understand who is making the decision on your idea. Is it a single person or is it a committee? If it is a committee, you will need to know the mandate of that committee. This will help you refine your framing of the idea – make it match the mandate. Who is on that committee and how will each person vote? Be systematic about mapping your support and take the time to connect with each person before the discussion of your item. If they have any concerns, this allows you to discuss them outside of the formality of the committee, to gather valuable feedback to better refine your idea and to build sup-port one person at a time.

What is your power position?This is often overlooked, but where do you sit in terms of positional power compared with the decision maker(s)? Are you a direct report to the decision maker? Are the committee members reporting to you? Is the decision maker in another portfolio... and where does that person

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Figure 1) Three key steps for moving your argument forward


Taylor


fit relative to you or your supervisor? Power and politics are prevalent in every large organization and often have a significant impact on which ideas move forward and those that do not. Determining the answers to these questions will help you to leverage your own power and, perhaps, that of your supporters.

Should someone else take it forward?After contemplating your power position, does it appear that you are a little fish with a big idea? Perhaps you need a bigger fish to bring your idea forward. For example, if you need an executive vice president to sign off and you are a staff respiratory therapist, that often represents a span of three to four organizational levels in a large hospital, and the first question the executive vice president would likely ask is where your manager or director sits on the issue. You will have more success if you engage your manager or director and leverage their support when bringing it forward.

Relationships matterYou will have a much easier time moving your idea forward if you have a relationship with the people that you need support from – if they happen to like you, even better. This underscores the importance of networking within your organization and reinforces the value of meet-ing with the members of a committee one-on-one while ‘paving the way’.

STEP 3: WIn THE DECISIOnAfter you have completed your homework, built support and are con-fident on how the decision will go, you are now ready to present your proposal. There are a couple of final points to consider.

Presenting your caseObviously, preparing your presentation beforehand is of key import-ance. You will want to keep your presentation simple, factual and concise. You can include the answers to the questions that you have already identified and you will want to avoid letting the conversation stray from your main points. Run it by a trusted person to get honest critique; the more removed they are from the issue and the more objective the better. As always, how you say something is often more important than what you say; therefore, tone, body language and style all matter. Then, run through your presentation enough times that if you are asked some questions midway through, it will not throw you.

Identify your best alternative to a negotiated agreement (aka ‘Plan B’)The ‘best alternative to a negotiated agreement’ is an expression from the world of negotiations but it essentially means ‘Plan B’. When someone says ‘No’, there is often a possibility of winning some conces-sion or finding a compromise. So, plan ahead for this and try to be as prepared with the details on the alternatives as you were with your original idea. If the discussion is starting to erode support for your

proposal, you may be able to win support for part of your idea or even win a reasonable alternative. Either way, it is still a step forward and you can always use that as a new starting point to try again later.

STEP 4: BUIlD a REPUTaTIOn BY IMPlEMEnTaTIOn

Congratulations, you won the decision! Now what? Well, your next idea’s success begins right now. People who build a reputation as ‘some-one who delivers’ are the ones that decision makers support the most. You definitely do not want to be seen as that person who always brings ideas forward but never actually does anything about them. Therefore, make a point of reporting back to the decision maker(s) on your progress and absolutely share your success with others.

BUSInESS CaSE TEMPlaTEThere is no better way to track your progress than by writing it down. The business case template presented in Figure 2 captures all the above and will help you develop your idea, pave the way and to win the decision.

DISClOSURE: Kevin Taylor is the CEO and Registrar at the College of Respiratory Therapists of Ontario (CRTO) – the regulatory body for Respiratory Therapy in Ontario, Canada – and is a member of the National Alliance of Respiratory Therapy Regulatory Bodies (NARTRB). This article is adapted from a presentation at the CSRT Educational Conference and Trade Show 2013.

RECOMMEnDED REaDIng1. Fisher R, Ury WL, Patton B. Getting to YES. New York:

The Penguin Press, 2011:1-170.

Figure 2) Business case template. BATNA Best alternative to a negotiated agreement

Please recycle. Printed in Canada. © 2013, 3M. All rights reserved. 3M is a trademark of 3M.Used under license in Canada. SpotOn and SpotOn logo are trademarks of Arizant Healthcare, Inc; a 3M Company. Used under license in Canada. 1309-02382


how do we measure the quality of a respiratory therapy education program?

Sandra Biesheuvel BSc RRT

Correspondence: Ms Sandra Biesheuvel, Department of Respiratory Therapy, University of Manitoba, NA 629 700 McDermot Avenue, Winnipeg, Manitoba R3E 0T2. Telephone 204-787-1668, e-mail [email protected]

commentary

At the beginning of a new academic year, respiratory therapy edu-cation programs across the country welcome new students into

the program and welcome returning students into their next year of study. The faculty returns to teaching feeling relaxed and refreshed after a break from the classroom. We dust off our lectures and prepare to do the same thing that we did last year. Or do we?

Is it sufficient to continue doing what we did last year because it appeared to work? The course objectives were met and the students all fared well on the examinations and laboratory evaluations. Does this mean that we did a good job? How do we know if we delivered a course that was of sufficient quality? Whether we are working at the bedside, in management, sales or education, every respiratory therapist (RT) should ask, ‘Am I doing my job right? Am I doing the right thing?’ These questions are extremely important to the RT clinician whose job it is to provide safe, quality, client-centred care. These questions are important to those who work in the field of respiratory therapy education because we are responsible for educating and training future generations of RTs. How do we know if we are doing a good job in educating and training our students? How do we measure the quality of a respiratory therapy education program? To answer that, we must first ask what is it that we want to achieve. The respiratory therapy educa-tion program at the University of Manitoba (Winnipeg, Manitoba) developed a five-year strategic plan that would answer the ‘what’. Our mission – and thereby our ‘what’ – is “to create, disseminate and pre-serve knowledge in health and Respiratory Therapy through research, education and service, in collaboration with our stakeholders”(1). Our goal is to produce degree-RTs who can work effectively in any setting, delivering collaborative, evidence-based care, and who can advance the profession through research and advocacy (1). Through the stra-tegic plan, we have identified the needs of the university and students, our community and our stakeholders, and have developed four stra-tegic initiatives. In achieving these initiatives, we will answer what it is that we wish to achieve: 1. A quality entry-to-practice RT education program2. Scholarship that advances the profession3. Administrative and operational excellence4. Community engagement and service (1)

The next questions we must ask are how are we going to achieve these initiatives, and how will we know if we have achieved them? Mission and vision and values statements look great on paper, but the key to successfully achieving the goals of a strategic plan is to measure the actions of implementing the plan. This requires the development of a quality roadmap. Each strategic initiative becomes a quality issue on the roadmap. A total of 12 objectives, each linked to several actions, were developed to measure how we will achieve our strategic initiatives. The actions are measured over a period of time, and results are collated and analyzed. This process thereby forms our indicators and measurements of success or lack thereof. The quality plan can be modified as goals are achieved or as indicators require alteration. In our quality roadmap, the first strategic initiative has been developed as follows:

STRaTEgIC ISSUE: QUalITY EnTRY-TO-PRaCTICE RT EDUCaTIOn PROgRaM

Objectives • To deliver a national calibre, cutting-edge curriculum• Enhance and develop relevant faculty breadth of experience• Recruit and retain highly qualified and diverse student cohorts (1)

From these objectives, we developed specific actions that will be measured over a period of time, with most measurements occurring on an annual basis. Expanding on the first objective, our actions are the following:• Develop a new Bachelor of Medical Rehabilitation in Respiratory

Therapy (BMR-RT) curriculum• Increase stakeholder and clinical community involvement• Enhance simulation delivery within the academic portion of the

program

Each action has several performance measures with subsequent outcomes. The outcomes are the descriptors of success. The remaining three strategic initiatives were mapped in a similar manner to com-plete the quality roadmap for the RT education program. Strategic plans look impressive on paper and can be intimidating, but if the plan is analyzed one strategic initiative at a time, it becomes manageable and doable in the time frame allotted.

I believe that a strategic plan tells you where you are going, it becomes your destination, and the quality roadmap tells you how you are going to get there. Goals of the organization or program are identi-fied and, when the goals are achieved, you have reached your destina-tion. The actions that you take to reach those goals become the directions that you follow along the map.

Actions produce outcomes and, with many health care profession education programs providing Bachelor’s or Master’s degrees as entry-to-practice, our educational institutions need to ask, ‘What is the best possible outcome that we can provide for our students?’ The Canadian Society of Respiratory Therapists has created a position statement advocating for a degree as entry-to-practice for RTs in Canada (2). This is not about ‘keeping up with the Joneses’, but about keeping up with the changing face of health care. “The graduate RT must be prepared to enter the workforce as the expert on respiratory care and be prepared to consult on the provision of care” (3). This requires our students not only to be competent in using respiratory therapy equipment, but also to be able to apply evidence-based knowledge to manage and treat patients. We are teaching our students what it means to promote a culture of client-centred care, in which clients, patients, family mem-bers and all members of the health care team have a voice in what care is delivered and how it is delivered. In addition to ensuring that all components of the national competency profile are incorporated and measured in our curriculum, we must teach what it means to be a health care professional in the 21st century. We want our students to learn to deliver respiratory therapy services using different models of care in diverse settings. We want them to develop leadership skills that will aid them in decision making and navigating team dynamics and conflict.


Biesheuvel


In spring 2011, the University of Manitoba RT program began the process of curriculum renewal. We deconstructed each course and matched the objectives to the national competency profile. This enabled us to identify redundancies between courses as well as areas that needed more clearly defined objectives. Two such areas are inter-professional education and patient safety. In 2008, the University of Manitoba Interprofessional Education Initiative was formed by admin-istrators, faculty and students from 13 academic units with the belief that interprofessional education for collaborative patient-centred practice is fundamental in building a stronger health care system (4). These learning opportunities enable students to learn ‘from, with and about each other’ (5). The interprofessional curricula framework has been mapped into the new RT curriculum so that our students will learn and practice how to collaborate with other health professions to promote optimal health outcomes for individuals and communities, increase satisfaction with care for both individuals and health care providers, and improve efficiencies within the health care system (5).

Another area of competencies that we addressed is related to patient safety. The Canadian Patient Safety Institute (CPSI) has developed a framework of safety competencies required by health pro-fessionals to promote a culture of safety. The intent of these competen-cies is to “raise the bar for health care education in Canada, and possibly around the world” (6). The CPSI competencies have been mapped into the respiratory therapy curriculum, and our students will be provided with interprofessional learning opportunities to practice their role and collaborate with other health profession students in providing safe, quality care.

We are preparing our students to graduate with the skills to further their careers in research related to respiratory therapy, to continue to grow as collaborative health care practitioners and become leaders in the field. Similar to all respiratory therapy practitioners, managers and

educators in any sector, we are dedicated to preparing the future of our profession.

It is our intent that the strategic plan and quality roadmap of the respiratory therapy program at the University of Manitoba will keep us on track to deliver a quality education program. We will be able to measure our progress and make changes as needed so that we can, in fact, measure the quality of our respiratory therapy education program. Now that I am in my fourth year of teaching, and 20th year in the profession, I continue to ask myself the same questions I have asked since graduating: Am I doing my job right? Am I doing the right thing?

REFEREnCES1. University of Manitoba School of Medical Rehabilitation,

Department of Respiratory Therapy Strategic Plan, 2012.2. Canadian Society of Respiratory Therapists Board of Directors.

CSRT Position Statement: Degree as Entry-to-Practice, 2012. <www.csrt.com/en/professional/degree-entry-to-practice.asp> (Accessed August 20, 2013).

3. Barnes TA, Gale DD, Kacmarek RM, Kageler WV. Competencies needed by graduate respiratory therapists in 2015 and beyond. Respir Care 2010;55:601-16.

4. University of Manitoba Interprofessional Education Initiative. Interprofessional Planning Through Interprofessional Education: Five-Year Summary. Winnipeg, 2014. <http://umanitoba.ca/programs/interprofessional/media/UM_WRHA__IECPCP_Final_Dec_2013.pdf> (Accessed December 10, 2013).

5. MacDonald L, Stern M, Bowman S, et al, eds. University of Manitoba-Winnipeg Regional Health Authority Interprofessional Education and Collaborative Practice Curricula Model and Learning Continuum Blueprint, 2013.

6. Frank JR, Beirn S, eds; on behalf of The Safety Competencies Steering Committee. The Safety Competencies: Enhancing Patient Safety Across the Health Professions. Ottawa: Canadian Patient Safety Institute, 2008.


improving survival outcomes in lung transplant recipients through early detection of bronchiolitis

obliterans: daily home spirometry versus standard pulmonary function testing

Kevin S Robson BMR RRT1,2, Andrew J West MAppSc DipPH RRT1

1School of Medical Rehabilitation, Faculty of Medicine, University of Manitoba; 2Department of Respiratory Therapy, Victoria General Hospital, Winnipeg, Manitoba

Correspondence: Mr Andrew J West, School of Medical Rehabilitation, Faculty of Medicine, University of Manitoba, 625-700 McDermot Avenue, Winnipeg, Manitoba R3E 0T2. Telephone 204-787-1197, fax 204-787-4862, e-mail [email protected]

Patients diagnosed with advanced lung disease remain significantly symptomatic despite medical therapy and experience statistically

high short-term mortality (1). Many of these patients desperately seek symptomatic relief and would consider undergoing lung transplanta-tion to improve their quality of life. Since the first successful heart-lung transplant was performed in 1981 by Dr Bruce Reitz (2), an accepted intervention has emerged for patients with end-stage cardio-pulmonary disease. An estimate by the Global Observatory on Donation & Transplantation in 2011 reported an average of 3200 lung transplants performed each year from 2006 to 2010 worldwide (3),

increasing to 3972 in 2012 (4). Although many patients live longer with an improved quality of life after lung transplantation, a signifi-cant proportion experience adverse effects and comorbidities, often leading to death sooner after transplant than predicted without (1).

The need for investigation is a result of notably poor survival out-comes for lung transplant recipients specifically. According to a 2008 publication from the Registry of the International Society for Heart & Lung Transplantation (ISHLT) (5), lung transplant recipients had an overall median survival of 5.3 years. The registry described long-term survival rates after lung transplantation of 79% at one year, 63% at

review


KS Robson, aJ West. Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: Daily home spirometry versus standard pulmonary function testing. Can J Respir Ther 2014;50(1):17-22.

BaCKgROUnD: Long-term lung transplant success is limited by bron-chiolitis obliterans syndrome (BOS), a form of chronic allograft rejection that manifests in the majority of patients by five years post-transplant. Frequent monitoring of pulmonary function measurements through the use of daily home spirometry may have the capability to detect the onset of BOS sooner than standard pulmonary function testing. Early detection of BOS would confer a treatment advantage that may improve survival out-comes for lung transplant recipients. METHODS: A systematic review of current evidence was used to deter-mine the effectiveness of daily home spirometry as a BOS detection tool, in addition to its impact and survival outcomes. Articles were included in the present systematic review if they were randomized control studies and if their purpose(s) included investigation of spirometry as a BOS detection tool in lung transplant patients. RESUlTS: A primary search of databases yielded 115 unique citations, with an additional four citations identified through a secondary review of the reference lists of retrieved articles. After application of all inclusion and exclusion criteria through abstract and full-text review, eight random-ized controlled trials were included in the review. DISCUSSIOn: Forced expiratory volume in 1 s (FEV1) has been identi-fied as the most reliable diagnostic tool for detecting the onset of BOS. Two studies compared the use of traditionally scheduled pulmonary func-tion testing with daily home spirometry and found BOS stage 1 to appear 341 days earlier with home spirometry (P<0.001). Other studies that investigated the impact early detection had on survival showed a positive trend toward freedom from BOS and reduced rates of retransplantation, although these results did not reach statistical significance (P<0.07).COnClUSIOn: Daily home spirometry has been shown to lead to earlier detection and staging of BOS when compared with standard pulmonary function testing. Although FEV1 has been shown to be the most sensitive and reliable marker of BOS onset, the impact of earlier staging via home spirometry on survival has not been reliably determined.

Key Words: Bronchiolitis obliterans; Forced expiratory volume; Home monitoring; Lung transplantation; Rejection; Spirometry

améliorer la survie chez des greffés pulmonaires grâce au dépistage précoce de la bronchiolite oblitérante : la spirométrie quotidienne à domicile ou l’exploration fonctionnelle respiratoire standard

HISTORIQUE : La réussite à long terme des transplantations pulmo-naires est limitée par le syndrome de bronchiolite oblitérante (SBO), une forme de rejet chronique de l’allogreffe qui se manifeste chez la majorité des patients dans les cinq ans suivant la transplantation. La surveillance fréquente des mesures de fonction pulmonaire par la spirométrie quotidienne à domicile pourrait déceler l’apparition du SBO plus rapidement que l’exploration fonctionnelle respiratoire standard. Le dépistage précoce du SBO confère un avantage thérapeutique qui peut améliorer la survie des greffés pulmonaires. MÉTHODOlOgIE : Les chercheurs ont procédé à l’analyse systématique des données probantes à jour pour déterminer l’efficacité de la spirométrie quotidienne à domicile comme outil de détection du SBO, ainsi que son effet sur la survie. Les articles étaient retenus s’il s’agissait d’études aléatoires et contrôlées dont l’un des objectifs consistait à évaluer la spirométrie comme outil de dépistage du SBO chez les greffés pulmonaires. RÉSUlTaTS : Les chercheurs ont obtenu 115 citations uniques au moyen d’une recherche primaire des bases de données, et quatre autres après un examen secondaire des listes de références des articles extraits. Après l’application de tous les critères d’inclusion et d’exclusion par l’analyse des résumés et des textes intégraux, ils ont retenu huit essais aléatoires et contrôlés. EXPOSÉ : Il a été établi que le volume expiratoire maximal par seconde (VEMS) est l’outil diagnostique fiable pour dépister l’apparition du SBO. Deux études comparant l’utilisation de l’exploration fonctionnelle respira-toire habituelle à la spirométrie quotidienne à domicile ont décelé que le SBO de stade 1 était décelé 341 jours plus tôt grâce à la spirométrie quoti-dienne (P<0,001). D’autres études sur l’effet du dépistage précoce sur la survie ont révélé une tendance positive vers la guérison du SBO et une diminution du taux de retransplantation, même si ces résultats n’étaient pas statistiquement significatifs (P<0,07).COnClUSIOn : L’analyse a révélé que la spirométrie quotidienne à domi-cile assure un dépistage et l’établissement du stade du SBO plus rapidement que l’exploration fonctionnelle respiratoire. Même si le VEMS est le mar-queur le plus sensible et le plus fiable d’apparition du SBO, l’effet sur la survie de l’établissement du stade de la maladie par la spirométrie à domicile n’a pas été établi avec fiabilité.

Robson and West


three years, 52% at five years and 29% at 10 years (5). Survival out-comes for lung recipients remain inferior by nearly one-half of those achieved with other solid-organ transplant procedures. Heart trans-plant recipients have survival rates of 88%, 75% and 56% at one, five and 10 years, respectively (5,6). Similar differences are apparent with recipients of deceased donor livers, having respective survival rates of 88%, 74% and 60% (5,6). Lung transplantation clearly has a signifi-cant early postoperative mortality rate and, often, the recipient may experience significant morbidity associated with transplant and immunosuppression (1).

The major cause of death post-lung transplantation has remained constant over the past three decades. Graft failure and infection have been the cause of most acute rejections (ie, first 30 days), whereas bronchiolitis obliterans syndrome (BOS) has been linked to the cause of almost all chronic rejections (ie, after the first year) (7-9). BOS presents as a fibrotic inflammatory process that affects the small airway bronchioles (9). The disease process can be devastating, involving rapidly progressive airways obstruction, eventually leading to respira-tory failure (10-12). The development of BOS is believed to be due to chronic graft rejection and has been routinely treated with increased immunosuppression therapy. The concern is that most often, immuno-suppression is not successful (9-11). Once BOS is identified, altera-tions in immunosuppression generally prove, at best, to be only of modest benefit (11). An irreversible decline in forced expiratory vol-ume in 1 s (FEV1) obtained through pulmonary function testing, has shown to be the most well-documented tool to diagnose BOS (11,13). Early intervention, which is essential to improving long-term survival, is dependent on the earliest possible detection. Several studies have suggested that the frequent monitoring of pulmonary function can provide such detection capability (13-19).

The relative lack of improvement in lung transplant rejection rates is a concern for an ageing population in which the burden of chronic lung disease is increasing. The present article systematically reviews current research regarding the use of spirometry as a tool for BOS detection in lung transplant recipients, particularly through FEV1 values, and the role home spirometry can play in monitoring for FEV1 changes sooner. A secondary outcome of interest in the present analy-sis was the impact of early detection using spirometry on survival.

METHODSSearch strategyA primary search of computerized databases (PubMed, Scopus and MedlinePlus) was conducted in January 2014. Key terms for the search included “bronchiolitis obliterans”, “lung transplantation”, “rejec-tion”, “spirometry”, “forced expiratory volume”, “home monitoring” and “mortality”. A secondary search using the reference lists of all retrieved articles was conducted to identify additional studies. Both searches were limited to human studies in English that were published between 1993 and 2014. No age, sex or race limitations were applied to the search.

Study selectionArticles were included in the present systematic review if they were randomized controlled studies and their purpose(s) included investiga-tion of spirometry as a BOS detection tool in lung transplant patients. Articles were excluded from the systematic review if they exhibited any one of the following criteria: methodologies other than random-ized clinical trials, including reviews, observational studies or com-mentaries; inadequate randomization methods; failure to report on a standardized outcome related to the purpose (ie, decrease in FEV1, retransplantation or mortality); and the use of spirometry as a detec-tion tool for pathologies other than BOS.

Systematic review processThe review team consisted of a clinical respiratory therapist (KSR) and a research respiratory therapist (AJW). Initial abstract review of all citations retrieved was performed by one investigator (KSR) and articles were chosen for further review based on the inclusion criteria (KSR). Full-text review of those articles was performed independently by both team members to determine potentially relevant studies for final inclusion. Any disagreement between the reviewers was resolved by consensus.

The Cochrane risk of bias framework for randomized controlled trials (20) was used to determine the risk of bias. Each study was independently critically appraised by the two researchers, and any disagreement between reviewers was resolved by consensus.

RESUlTSThe primary search of the databases yielded 115 unique citations, with an additional four citations identified through a secondary review of the reference lists of retrieved articles. After application of all inclu-sion and exclusion criteria through abstract and full-text review, eight randomized controlled trials were included in the review. Each of the eight studies was determined to exhibit a low risk of bias. Figure 1 provides an overview of the trial flow.

The trials identified for inclusion in the present review are sum-marized in Table 1. All included trials used either a measured FEV1 <20% of baseline predicted values or transbronchial biopsy (TBB), or a combination of the two, as criteria for diagnosing BOS. The primary outcomes of each trial were measured using spirometry to evaluate the utility of FEV1 values as a staging tool for BOS (confirmed with TBB as the control), or to evaluate the detection capabilities of home spi-rometry versus routine clinical testing. In all studies, pulmonary func-tion testing was performed following the standards established by the American Thoracic Society at each clinic visit.

DISCUSSIOnThe early identification of chronic rejection following lung trans-plantation is problematic due to the lack of reliable diagnostic testing. The once commonly used method of TBB to detect BOS is now rarely performed due to its low sensitivity (17). Therefore, the diagnosis of chronic airways rejection is generally based on changes in pulmonary function, specifically FEV1. BOS has been commonly defined as a decline in FEV1 of >20% from the post-transplant baseline in the absence of acute rejection or active infection (11,13-16). The terms ‘BOS’ and ‘chronic rejection’ have become synonymous with one

Figure 1) Flow diagram of included trials. RCT Randomized controlled trials

Results of database search strategy (133 cita�ons)

Cita�ons retrieved from review of reference lists of retrieved ar�cles

(n=4)

Duplicated cita�ons excluded (n=18)

Cita�ons retrieved by abstract review

(n=119)

Cita�ons excluded (n=44)

Cita�ons retrieved for full-text review

(n=75)

Cita�ons excluded (n=67) • No relevant outcome

measures (n=23)

• Not original research (n=6)

• Inappropriate study design (n=38)

RCTs included in systema�c review

(n=8)

Survival outcomes in lung transplant


another when considering lung transplant, and the use of monitoring declines in FEV1 has been shown to be a reliable diagnostic tool. However, whether the use of spirometry to monitor FEV1 changes is

the best test for early detection of BOS is yet to be established. It is, therefore, necessary to consider other detection strategies to determine what will show signs of BOS in its earliest and most treatable stages.

TaBle 1Characteristics and primary outcomes of randomized controlled trials included in the present systematic reviewauthor (reference), year Sample

Method of BOS identification Comparison Outcomes evaluated Primary findings

Burton et al (13), 2007

346 SLT/DLT/HLT recipients

Average maximal FEV1 obtained through spirometry >3 weeks apart

Maximal baseline FEV1 obtained post-transplant

BOS grade 1 identified as a sustained FEV1 <80% relative to baseline

Baseline FEV1 values to be strongly associated with freedom from BOS stage 1, and long-duration BOS-free survival

Lama et al (14), 2005

197 SLT recipients alive >3 months post-transplant

FEV1 <20% from baseline (determined from the average of 2 measurements made at least 3 weeks apart)

Maximal baseline FEV1 and FEF25%-75% obtained post-transplant

Potential BOS (stage BOS 0-p) defined by an FEV1 <10% to 19% baseline and/or >25% decrease in FEF25%-75%

BOS 0-p was associated with higher sensitivity, specificity, and positive predictive values over FEF25%-75% criterion. Of patients who met BOS 0-p criterion, 81% developed BOS stage 1 or died within 3 years

Bjotuft et al (15), 1993

Eight SLT recipients with emphysema

TBB performed routinely at follow-up and when respiratory symptoms arose*

Persistent (>2 days) decrease in FVC or FEV1 >10% over a 7-day average

Acute cellular rejection and/or chronic rejection confirmed through TBB

In 16 of 23 confirmed rejections, FEV1 and FVC decreased significantly (P<0.001), with a >10% decrease in the 7-day average before TBB

Becker et al (16), 1994

31 LT recipients TBB performed routinely or post-clinical suspicion of an acute process†

Best baseline FVC, FEV1, and FEF25%-75% obtained postoperatively

The magnitude in the drop of FVC, FEV1 and FEF25%-75% at the time of an abnormal biopsy when compared with baseline

A mean drop in FVC from 71% to 62% predicted (P<0.00001), and FEV1 from 66% to 58% predicted (P<0.0001) compared with baseline. A statistically significant change was not apparent in FEF25%-75% (P=0.13)

Finkelstein et al (18), 1999

45 LT recipients Clinical staging of BOS using the ISHLT algorithm based on FEV1 changes relative to baseline obtained clinically

The average of 3 FVC manoeuvres performed once daily

Number of days from date of transplant to the first detection of any stage BOS (calculate from both clinical and home FEV1 measurements)

Staging based on home measurements detected a decline to stage 1 an average of 341 days earlier than clinic measures (P<0.001), and further declines to stage 2 and stage 3 were detected an average of 144 days (P<0.05) and 159 days earlier than clinic-based staging

Lama et al (23), 2007

111 LT recipients FEV1 <20% predicted baseline post-transplant

FEV1 % predicted at 0, 6, 12 and 18 months after BOS onset

Decline of FEV1 after BOS stage 1 onset

The rate of decline of FEV1 % predicted changed significantly during the first 2 years after BOS onset (P<0.0001). The steepest decline in FEV1 % predicted was apparent in the first 6 months and was highly statistically significant (12% decline; P<0.0001)

Finkelstein et al (24), 1997

19 LT recipients FEV1 <20% predicted baseline values

The average of 3 FVC manoeuvres performed once daily

FEV1 declines measured from daily spirometry at home

Using home spirometry, the onset of decline began an average of 284 days before diagnosis of chronic rejection, which was significantly earlier (P<0.05) than the decline observed with clinic pulmonary function testing

Sengpiel et al (27), 2010

56 LT recipients Home spirometry- based FEV1 <20% baseline predicted value

Home spirometry with data transfer equipped bluetooth

Time from onset of symptoms to physician consultation during the first 6 months after lung transplantation

Median time to first consultation (P=0.60) and frequency of consultation (P=0.06) did not differ significantly in the 2 groups

*All subjects underwent surveillance bronchoscopy with bronchoalveolar lavage and transbronchial biopsies one and two months after transplantation, and every two months during the remainder of the first post-transplant year. After one year, bronchoscopic examinations were continued every three months until the subject had 12 consecutive rejection-free months. In addition, the subjects underwent bronchoscopy with lavage and transbronchial biopsies whenever signs or symptoms sug-gestive of respiratory infection occurred, or when clinic forced expiratory volume in 1 s (FEV1) decreased >15% compared with previous clinic visits; †All patients were screened for rejection with bronchoscopy and transbronchial biopsy (TBB) performed at three and six weeks, and at three, six, nine and 12 months, and every six months after the first year. BOS Bronciolitis obliterans syndrome; DLT Double-lung transplant; FEF25%-75% Forced expiratory flow between 25% and 75% of forced vital capacity (FVC); FEV1 Forced expiratory volume in 1 s; HLT Heart-lung transplant; ISHLT The International Society for Heart & Lung Transplantation; LT Lung transplant; SLT Single-lung transplant

Robson and West


Comparison of BOS detection strategies A study by Cook et al (21) examined 22 transplant recipients at two points in time, approximately one and two years after the procedure. The inclusion of post-transplant patients who did not have BOS at either occasion acted as effective study controls. For the purpose of the study, they defined BOS as a 20% drop in FEV1 in the post-transplant period. At the first examination, five of the 22 patients had BOS and, at the second examination, 10 of 22. These outcomes allowed the authors to examine the sensitivity and specificity of various other diagnostic tests at each point in time. The tests they studied included maximum mid-expiratory flow (MMEF), indexes of maldistribution of ventilation and perfusion derived from radioiso-tope scans (V/Q scan), and high-resolution computed tomography scans to examine air trapping, perfusion patterns and bronchial dilation (21).

Several of the studies included in the review examined the cap-acity and efficacy of different tests to detect BOS. Comparing the findings of Cook et al (21) with those whose focus was on BOS diag-nostic testing, similar conclusions emerged throughout. Collectively, it was found that patients with BOS (based on low FEV1) also had sig-nificantly lower than predicted MMEF (55.8%) (16,17,22). However, Cook et al (21) found that a significant portion of their subjects without BOS also had low MMEF (39.5%). V/Q scans showed some-what less abnormality compared with MMEF, but often more in those without BOS. Overall, V/Q scan abnormalities at first examination did not predict the presence of BOS at second examination with any reliability (P=0.016). Computed tomography scanning was shown to be useful in relation to the severity of subsequent BOS (ie, subjects with severe BOS at the second examination were likely to have had abnormal perfusion and air trapping at the first examination) (21,22). However, the focus is not on detecting the severity of BOS, but rather on the detection of onset. Hence, it is evident that other forms of BOS detection show no strong evidence in being more useful or reliable than monitoring the decline in FEV1 values.

BOS staging using spirometric measuresTBB was once considered to be the ‘gold standard’ for the diagnosis of BOS; however, the sensitivity for diagnosis varied from 15% to 78% (17). Due to poor sensitivity, and the associated morbidity and mortal-ity, the BOS staging system was established by the ISHLT in 1993 (18,19). This staging system is based on airflow limitation (a percent-age change from a baseline post-transplant FEV1 obtained on formal clinical spirometry) with or without the diagnostic histological finding of BOS. The ISHLT concluded that FEV1 was the most reliable and consistent clinical pulmonary function test parameter that could pro-vide an indication of graft function (18,19). A staging algorithm based on FEV1 was developed to classify the levels of dysfunction in BOS. Stage 0 is reserved for FEV1 >80% of maximum baseline value and implies no significant abnormality. Stages 1 to 3 indicate a worsening condition, with 66% to 80%, 51% to 65% and ≤50% of maximum

baseline values, respectively. The 1993 and revised 2002 ISHLT BOS stages are outlined in Table 2 (19).

Implementation of the ISHLT algorithm has been adopted world-wide by transplant and pulmonary function clinics as a means of mon-itoring BOS. Clinically, FEV1 results are gathered through spirometry and are generally measured at monthly, quarterly or yearly intervals depending on the length of time since transplant. Results are inter-preted based on declines in FEV1 from the maximum FEV1 levels attained since transplant (23). These maximum FEV1 levels define the FEV1 baseline for the allograft recipient, and are determined based on the average of the two previous highest consecutive FEV1 measure-ments obtained in clinic at least three to six weeks apart. Declines are determined as percent decreases in FEV1 from previously established baseline values (23,24). While the staging of BOS is primarily based on a decline in FEV1, several studies have indicated that a decrease in forced expiratory flow between 25% and 75% of vital capacity (FEF25%-75%) is also a sensitive marker for the onset of BOS (14,16,23).

In 2002, the ISHLT consensus panel proposed a new stage, desig-nated ‘potential BOS’ or ‘BOS 0-p’, defined as an FEV1 of 81% to 90% of baseline or a FEF25%-75% <75% of baseline (14). This new stage (described in Table 2) is meant to alert the clinician to the increased risk for subsequent BOS among patients with slight declines in lung function, and to indicate the need for close functional monitoring. Spirometric measurements at regular intervals are critically important to detect evidence of airflow obstruction before the development of clinical symptoms. Thus, pulmonary function testing is strongly relied on as one of the earliest tests for detection of a graft complications such as BOS.

During the first year post-transplant, it is common practice that lung transplant recipients undergo biweekly or monthly spirometric testing. Monthly testing is deemed the minimum frequency in accord-ance with American Thoracic Society criteria for acceptability and reproducibility (25). At later points in time, measurements every two or three months are often performed instead (25). BOS, as a form of chronic graft rejection, is not often encountered before the first year post-transplant. The problem arises from less frequent monitoring occurring when the disease process is most likely to develop. More frequent monitoring via home spirometry may be an optimal solution. Daily home spirometry may detect a decline in pulmonary functional parameters earlier than regularly scheduled outpatient clinic visits, and may be invaluable as a regular component of follow-up for lung transplant recipients (25,26).

The effectiveness of home spirometryThe concept of home spirometry is not a new one in the field of lung transplantation. That is, patients are typically advised to record home spirometry measurements once or twice per day. They are instructed to report persistent decrements in values to their lung transplant centres or pulmonologist (25-27). There are inherent problems with home spirometry, such as intermittent or noncompliance with daily or twice-daily testing, difficulty with interpretation of the data points, and patient denial and rationalization when decrements in function are obtained (26). Whether home spirometry is being implemented effi-ciently for the benefit of BOS staging remains unclear.

In a study by Finkelstein et al (18), the researchers analyzed home spirometric data sent weekly to a data centre via telephone from the patients’ homes. Unlike clinical testing, in which FEV1 measures are relatively infrequent, staging based on home measurements of FEV1 was determined for each day that home data were recorded. This made it possible to consider the persistence of the stage value when deciding on the actual occurrence of a new BOS stage. Persistence was defined as the number of consecutive reports for which the FEV1 decline resulted in the same BOS stage. A change in BOS stage indicated either an improving (decrease in stage value) or a deteriorating (increase in stage value) condition. The study highlighted the effect of persistence on concordance between clinic and home determinations of staging and the time to detect a stage change was evaluated.

TaBle 2International Society for Heart & lung Transplantation staging system for bronchiolitis obliterans syndrome (BOS)

BOS stage 1993 grading system2002 revised classification system

BOS 0 FEV1 >80% of baseline FEV1 >90% and FEF25%-75% >75% of baseline

BOS 0-p Not applicable FEV1 81% – 90% and/or FEF25%-75% ≤75% of baseline

BOS 1 FEV1 66% – 80% of baseline FEV1 66% – 80% of baselineBOS 2 FEV1 51% – 65% of baseline FEV1 51% – 65% of baselineBOS 3 FEV1 ≤50% of baseline FEV1 <50% of baseline

Adapted from reference 21. FEV1 Forced expiratory volume in 1 s; FEF22%-75% Forced expiratory flow between 25% and 75% of vital capacity

Survival outcomes in lung transplant


Persistence values of one to seven days were considered. The differ-ence in the time to each stage using clinic and home BOS staging was evaluated using the paired t test, and the results are summarized in Table 3 (24).

Finkelstein et al (19) performed a follow-up retrospective analysis involving 45 lung transplant recipients participating in a home spi-rometry monitoring program. The subjects in that study served as their own control because clinical and home spirometry measurements were collected concurrently. The determinants of BOS staging were based on home and clinical FEV1 values. Seventeen of the 45 subjects developed lung decline of at least BOS stage 1, at which time detec-tion was an average of 341 to 276 days earlier with home spirometry.

These studies found that home spirometry can detect a decline in pulmonary function significantly earlier than clinic spirometry reflected by BOS detection times that were statistically significant for both persistence requirement studies (P<0.001) (18,19). What can be concluded is that home spirometry may be a reliable and safe alterna-tive to frequent clinic-based pulmonary function testing in lung trans-plant recipients. Unfortunately, the study did not address the impact of early detection on survival outcomes.

The use of home spirometry for detection of BOS does not immedi-ately diagnose the condition and still requires the lung transplant recipient to undergo bronchoscopy to exclude alternative diagnoses. It does allow for the steps toward diagnosing BOS to be made earlier and more conveniently for patients living great distances from transplant centres. It would stand to reason that this may have an impact on graft and patient survival.

Impact on survivalA secondary outcome of interest investigated by the present review was whether the interventions to date have improved the survival outcomes for lung transplant recipients. No randomized controlled trials were identified that described this outcome, with the exception of one observational study that was eliminated from the formal review (28). The authors of a prospective cohort study, completed through the University of Minnesota (Minnesota, USA), collected a total of 132,822 daily spirometry readings from January 27, 2002 to January 23, 2009 (28). The study involved 246 patients whose records were included for analysis. The mean (± SD) age of the subjects was 49.3±11.8 years and there were 146 (59.4%) deaths on or before January 23, 2007. To determine the effect of home monitoring on pulmonary-related death, a competing risks analysis was performed. The results yielded a risk ratio of 0.416 (95% CI 0.123 to 1.407) among pulmonary-related mortality and a risk ratio of 1.347 (95% CI 0.508 to 3.572) for non-pulmonary-related mortality (28).

These findings suggest that risk was reduced in subjects with good spirometry adherence, but subsequently died from pulmonary-related causes. The adherence to home monitoring in the early years of the post-transplant period resulted in a trend toward improved survival. The competing risk regression analysis showed that the benefit came largely in the group that subsequently died from pulmonary-related causes (28). This was to be expected because monitoring pulmonary function would be most helpful in alerting a disease condition, similar to BOS, that has direct bearing on the lung.

The present study showed that home monitoring for post-lung transplantation patients has a positive impact on survival. Kaplan-Meier event-free analysis showed decreased freedom from BOS time in nonadherers (30%) compared with good (43%) or moderate (19%) adherers (P<0.014), and a tendency toward lower retransplantation rates (P<0.07), although this did not reach statistical significance (28). Further analysis of mortality causes showed a trend in greater reduction of pulmonary-related mortality but this also did not reach statistical significance.

COnClUSIOnSPulmonary function testing is the cornerstone of lung transplant recipient monitoring. It has the advantage of being noninvasive, reproducible, may be performed frequently and daily by patients at home and, in some cases, may be automatically transmitted by tele-phone or electronic means to a hospital. It is a useful procedure for early detection of preclinical allograft complications and consecutive early treatment. The FEV1 is a sensitive measure of allograft function and has been considered to be the most useful spirometric indicator for diagnosing and staging the extent of BOS. The ISHLT proposed that a persistent decrease in FEV1 >20% of its baseline value be diagnostic criteria for BOS. The ISHLT staging system for assessing the extent of BOS is now widely accepted. However, BOS primarily affects the distal airways and FEV1 is considered to reflect an already advanced oblitera-tive process. For this reason, other functional parameters that show small airways dysfunction better than FEV1 – such as FEF25%-75% – were proposed to be an earlier marker of BOS. The ISHLT was revised in 2002 to include FEF25%-75% measurements as a potential BOS marker.

Supportive evidence from several studies has led to the conclusion that FEV1 was the most reliable and consistent clinical pulmonary functional parameter that provided an indication of graft function. The problem with detecting BOS using FEV1 is that therapy seldom improves lung function, which is interpreted to indicate that the pathological process is irreversibly established. After examining the use of home spirometry in the largest study to date, it was found that BOS staging was detected notably sooner compared with clinic spiro-metric testing. Nonadherers did show decreased freedom from BOS, but it did not impact survival. Overall, home monitoring was shown to have a positive impact on survival, but was not statistically significant.

Whether the use of home spirometry for the detection of BOS achieves widespread use in the lung transplantation community is yet to be determined. Future investigations should consider evaluating the usage patterns of and barriers to widespread implementation of home spirometry in this context (29,30). Effort should also be made to iden-tify the most effective means of treating BOS once an early diagnosis has been established (30). Currently, it remains to be seen whether a several-month lead time in the diagnosis of BOS will translate to ear-lier stabilization of pulmonary function, a less limited patient and improved survival.

DISClOSURES: The authors have no financial disclosures or conflicts of interest to declare.

TaBle 3average number of days post-transplant to detect bronchiolitis obliterans syndrome (BOS) based on impaired forced expiratory volume in 1 s* values

BOS stagePatients who declined to stage, n (total n=45)

Number of days to detect BOS, mean

Clinic-based stagingHome spirometry: 1-day persistence†

Home spirometry: 3-day persistence†

1 17 591 250 (P<0.001) 315 (P<0.001)2 11 712 568 (P<0.05) 636 (NS)3 7 844 685 (NS) 713 (NS)

*Defined BOS as stage 1 <80% of baseline value, stage 2 <65% of baseline value, stage 3 <50% of baseline value using both clinic-based testing and home mea-surement; †Persistence refers to the number of consecutive daily reports for which the decline in forced expiratory volume in 1 s resulted in the same BOS stage. Adapted from Finkelstein et al (20). NS Not statistically significant

Robson and West


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a retrospective analysis of airway management in patients with obstructive sleep apnea and its effects

on postanesthesia care unit length of stayClaire A Brousseau BSc, Gregory R Dobson MD FRCPC, Andrew D Milne MD MSc FRCPC PEng

Department of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia

Correspondence: Ms Claire A Brousseau, Dalhousie University, 2109 Beech Street, Halifax, Nova Scotia B3L 2X7. Telephone 902-449-5233, e-mail [email protected]

Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing that has become increasingly prevalent in contempor-

ary society. OSA is characterized by periods of partial or complete obstruction of the upper airway during sleep, resulting in oxygen desa-turations (1), which can lead to angina, cardiac arrhythmias, and both systemic and pulmonary hypertension (2). Various daytime symptoms are also associated with OSA, including excessive daytime sleepiness, morning headaches, fatigue, irritability and personality changes (3). Although the pathophysiology of OSA depends primarily on pharyn-geal anatomy and stage of sleep (4), there are several factors that can contribute to the development of OSA. Obesity, craniofacial and upper airway structure, older age, sex (hormonal differences) and gen-etics can all contribute to the likelihood of an individual developing OSA (5). These risk factors and symptoms are of particular import-ance when preparing to manage OSA patients in the perioperative setting in terms of securing the airway, as well as in postoperative dis-charge planning. The prevalence of OSA in the general surgical popu-lation is reported to be 20% to 24%, of which 90% is undiagnosed (6), highlighting the importance of recognizing the common symptoms and risk factors in these patients.

During general anesthesia, definitive airway management is crucial to maintain ventilation and oxygenation throughout the surgical pro-cedure. The combination of physical properties, such as obesity, craniofacial and pharyngeal abnormalities, along with a decreased air-way patency and increased obstructive response to anesthetics and analgesic medications can all contribute to making OSA patients

potentially more difficult to intubate and manage (7,8). The Cormack-Lehane (CL) score is a common grading system used to quantify the ease or difficulty of intubation based on the extent of glottic structures apparent on direct laryngoscopy. Typically, grade 3 (only the epiglottis visible) or grade 4 (no glottic structures visible) views are considered to be ‘difficult’ intubations (9,10). Considering the loss of elasticity in the airway anatomy and excess adipose tissue around the neck that is characteristic of OSA patients, it is plausible that these patients can be more difficult to intubate (11).

Previous studies have shown an association between OSA and diffi-cult intubation (7,8,11-14). Hiremath et al (7) observed 15 patients who were difficult to intubate and found that eight (53.3%) had OSA compared with only two (13.3%) in the control group. Chung et al (12) also investigated a cohort of patients who were unexpectedly difficult intubate and found that 66% had OSA. Similarly, Siyam and Benhamou (13) found that difficult intubation occurred in 21.9% of OSA patients compared with 2.6% of control patients, and Bolden et al (14) reported that 15% of their OSA cohort experienced difficult intubations. However, Neligan et al (15) reported that OSA was not linked to CL airway grade nor difficult intubation in bariatric patients.

The present study examined the airway management techniques and relative difficulty of intubation of OSA patients in a large teach-ing institution. As a secondary outcome, the postanesthesia care unit (PACU) data for these patients were analyzed for PACU length of stay (LOS), apneas or related complications observed, and the effect of OSA on the PACU LOS.

original article


Ca Brousseau, gR Dobson, aD Milne. a retrospective analysis of airway management in patients with obstructive sleep apnea and its effects on postanesthesia care unit length of stay. Can J Respir Ther 2014;50(1):23-26.

Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing characterized by periods of partial or complete obstruction of the upper airway during sleep, resulting in oxygen desaturations. Symptoms and risk factors for OSA are of particular importance in the management of OSA patients in the perioperative setting. The present study collected data regarding the intraoperative airway management of OSA patients and their course in the postanesthesia care unit (PACU) over a six-month period. A total of 86 patients underwent general anesthesia, 63 of whom were intubated by direct laryngoscopy. Of these, 43% were classified as a grade 1 view by direct laryngoscopy, 43% were grade 2 and 14% were clas-sified as grade 3. Apnea events or periods of desaturation in the PACU were observed in 27% of cases. Length of stay was significantly longer for cases in which PACU nurses had indicated that OSA had affected the individuals’ postoperative course of treatment. Overall, OSA patients had an increased frequency of grade 3 views compared with the general popula-tion, and adjuncts were commonly used to help secure the airway in OSA patients. Symptomatic OSA patients placed increased demands on the PACU in terms of length of stay and hospital resources.

Key Words: Difficult airway; PACU complications; Sleep apnea

analyse rétrospective de la prise en charge des voies respiratoires chez des patients atteints d’apnée obstructive du sommeil ainsi que de ses effets sur la durée d’hospitalisation dans une unité de soins postanesthésiques

L’apnée obstructive du sommeil (AOS) est une forme de trouble respiratoire du sommeil caractérisée par des périodes d’obstruction partielle ou complète des voies respiratoires supérieures pendant le sommeil, qui provoque des désatura-tions en oxygène. Les symptômes et facteurs de risque d’AOS revêtent une importance particulière pour la prise en charge des patients atteints d’AOS en milieu périopératoire. La présente étude a permis de colliger, sur une période de six mois, des données sur la prise en charge intraopératoire et l’évolution des voies supérieures des patients atteints d’AOS à l’unité de soins posthanesthésique (USPA). Au total, 86 patients ont subi une anesthésie générale. De ce nombre, 63 ont été intubés par laryngoscopie directe, dont 43 % ont obtenu une vue de classe 1, 43 %, une vue de classe 2 et 14 %, une vue de classe 3. Dans 27 % des cas, les chercheurs ont observé des épisodes d’apnée ou de désaturation à l’USPA. La durée d’hospitalisation était beau-coup plus longue dans les cas où, selon les infirmières de l’USPA, l’AOS avait nui à l’évolution postopératoire du traitement. Dans l’ensemble, les patients atteints d’AOS présentaient davantage de vues de classe 3 que la population générale, et il fallait souvent utiliser des accessoires pour sécuriser leurs voies respiratoires. À l’USPA, les patients symptomatiques atteints d’AOS étaient hospitalisés plus longtemps et mobilisaient plus de ressources hospitalières.

Brousseau et al


METHODSResearch ethics board approval was obtained for the present study. The demographic and postoperative PACU LOS data were collected pro-spectively as a part of a quality control bed utilization project, and the intraoperative airway management data were extracted retrospectively from an anesthesia intraoperative management system (Saturn Information System, Draeger Medical, USA). Data collection occurred over a six-month period (July to December 2009) at the Queen Elizabeth II Health Centre (Halifax, Nova Scotia). During this time period, nurses in the PACU monitored postoperative patients with either sleep testing-confirmed or suspected OSA (based on the patients’ history and clinical symptoms) (16). For these patients, intraoperative information regarding airway management and anes-thetic strategies were collected in addition to any available OSA his-tory. A standardized form was used for documentation of patient demographics, ambulatory and admission status, PACU admission and discharge times, desaturation or apnea events in the PACU, and con-tinuous positive airway pressure (CPAP) use, if applicable, and if reported by the patient. PACU nurses were asked to indicate on the data collection form whether the patients’ OSA had affected their postoperative LOS and course of treatment. Nursing staff were also allowed to write in any comments that they believed were pertinent to the patients’ OSA and PACU stay. Intraoperative data were analyzed for ease of intubation and airway grade obtained, as well as airway management issues encountered and techniques used.

Statistical analyses were performed using ANOVA with Holm-Sidak post hoc comparisons. All statistical calculations were per-formed using SigmaPlot version 12.0 (Systat Software Inc, USA). Interval data were expressed as mean ± SD; the level of significance was set at P<0.05.

RESUlTSA total of 91 adult patients were included in the study over the six-month period (66 men, 25 women [Table 1]). The majority of patients had a formal diagnosis of OSA confirmed by testing (63% [n=57]) versus highly suspected OSA (37% [n=34]) based on clinical symp-toms. Women had a significantly higher body mass index (BMI) com-pared with men (Table 1). Most patients underwent an outpatient or same-day surgical procedure, and the majority underwent general anesthesia (Table 2).

Only two cases of difficult bag-mask ventilation (BMV) were docu-mented, whereas 45 (of the 86 total general anesthesia cases) were

reported as ‘easy’ to bag-mask ventilate. Airway management data were extracted for 86 of the patients (Table 3). Intubation by direct laryngoscopy was the most common method of airway management for patients undergoing general anesthesia. A supraglottic airway device (larygeal mask airway) was used in 17% of cases, and alternative intubation techniques, such as a Glidescope (Verthon Inc, USA) or lightwand, were used in 8% of cases. There was one awake fibreoptic bronchoscope-assisted intubation.

Overall, mean (± SD) PACU LOS for men was 187±118 min, and 156±90 min for women. Apnea events or periods of desaturation in the PACU were observed in 27% of cases. When these events were observed, the PACU LOS was significantly increased compared with individuals without documented desaturation or apnea events (LOS with apnea/desaturation = 270±135 min versus LOS without apnea/desaturation = 143±78 min; P<0.002). For cases in which the PACU nurses had indicated that the patient’s OSA status had impacted their course in PACU, the LOS was also significantly longer (OSA did impact LOS = 253±111 min versus OSA did not impact LOS = 148±98 min; P<0.024). However, PACU LOS was not significantly different between the confirmed and suspected OSA groups (con-firmed OSA = 159±101 min versus suspected OSA = 210±123 min; P=0.27). For patients with confirmed OSA, 13% used their CPAP machines postoperatively in the PACU, while 6% left their CPAP machine at home. Finally, there were no immediate deaths or severe complications noted in any cases.

DISCUSSIOnA total of 91 patients were included in the present study, the majority of whom were men (Table 1). This is consistent with the ratio of men and women with OSA that has been previously reported in the general surgical population (17).

Previous studies have shown that OSA patients are more difficult to intubate (7,8,11-13,14), while other studies have reported no cor-relation between OSA and difficult intubation or postoperative com-plications (15,18). The present study attempted to clarify, and further classify the methods and difficulty of OSA airway management in a large teaching hospital. For the general surgical population, the overall reported frequencies of each CL airway grade are: grade 1 – 99%; grade 2 – 1%; grade 3 – 1 per 2000; grade 4 – <1 per 100,000 (10). The results of the present study yielded 43% of patients with a grade 1 view, 43% with grade 2, 14% with grade 3 and no grade 4 views. The increased prevalence of grade 3 views, as found in the present cohort, supports previous work suggesting that OSA patients can be more dif-ficult to intubate. Bolden et al (14) found that 15% of their OSA cohort was reported to be difficult intubations, which correlates well with the findings from our study, which had 14% of patients with a grade 3 airway view. A more limited view of the airway due to excess neck tissues, as commonly encountered in OSA patients, could result in more difficulty or even failed attempts at intubation (11).

TaBle 1Demographic data of postoperative obstructive sleep apnea patients

Male (n=66) Female (n=25) PAge, years 56.9±12.5 54.8±8.7 0.42Body mass index, kg/m2 34.3±7.1 39.2±9.9* 0.01*

Data presented as mean ± SD unless otherwise indicated. *Statistically significant

TaBle 2admission status, surgical type and anesthetic method of postoperative obstructive sleep apnea patientsSurgical details n/n (%)Outpatient 21/91 (23)Same-day admission 57/91 (63)Inpatient 13/91 (14)Airway related 14/91 (15)Intra-abdominal/thoracic 32/91 (35)Major joint/arthroplasty 7/91 (8)Minor/peripheral surgery 38/91 (42)General anesthetic 86/91 (95)Spinal/regional anesthetic 5/91 (5)

TaBle 3Method used to secure and manage the airway in surgical obstructive sleep apnea patients undergoing general anesthesiaairway method n/n (%)Direct laryngoscopy 63/86 (73) Cormack-Lehane grade 1 27/63 (43) Cormack-Lehane grade 2 27/63 (43) Cormack-Lehane grade 3 9/63 (14) Cormack-Lehane grade 4 0/63 (0)Laryngeal mask airway 15/86 (17)Glidescope (Verathon Inc, USA) 5/86 (6)Lightwand 2/86 (2)Awake fibreoptic bronchocope 1/86 (1)

airway management and PaCU stay in OSa patients


Furthermore, 9% of patients in our cohort required some other adjunct or airway method to facilitate intubation (Glidescope, lightwand, awake fibreoptic bronchoscope).

The relationship between obesity and OSA has often been dis-cussed in the literature. O’Keefe and Patterson (19) found that OSA occurs independently of BMI. Generally, however, the consensus is that patients with OSA have a higher BMI, on average, than individuals without OSA (20,21). According to Chung et al (22), a BMI >35kg/m2

is the screening cut-off for OSA patients when using the STOP ques-tionnaire. Both the male and female OSA groups in the present study approached or exceeded a BMI of 35 kg/m2, which would be considered obese, and with both upper limits of the CIs reaching >40 kg/m2, which is considered to be clinically severe obesity (2).

Difficult BMV has also been reported in obese patients due to excessive adipose tissue, and restricted chest and lung anatomy (5). In some patients, difficult BMV could further compound airway manage-ment in the setting of a predicted difficult intubation. A previous study by Plunkett et al (23) found that difficult BMV was suggestive of undiagnosed OSA. Our study found only two documented cases of ‘difficult’ BMV, and 45 of the 86 general anesthetic cases (52%) were reported to be ‘easy’ to BMV. However, some patients may not have had any BMV performed as part of their induction (ie, rapid sequence induction intubations or direct laryngeal mask airway insertion with-out BMV), and the documentation of ease of BMV is inconsistent among anesthesia staff when describing the airway method in our institutional anesthesia infomation management system. Despite this, it is interesting to note the frequency of ‘easy’ BMV in our cohort, given the reported difficulty in laryngoscopy, and may be an area for future investigation.

The secondary outcomes of the present study relating to postopera-tive PACU events are in agreement with the previous literature. It has been shown that OSA patients experience more frequent postopera-tive complications (21). The present study was able to provide even more insight into the immediate postoperative period in the PACU and how OSA may adversely affect LOS. In particular, the results showed that LOS was significantly increased in cases for which the nurses reported that OSA had, in some form, impacted the LOS and course of treatment in the PACU. The PACU stay may have been negatively impacted by OSA through various different mechanisms, including delayed discharge due to limited intermediate care bed avail-ability for overnight monitoring, delayed home discharge due to apnea events or lack of a home CPAP machine, variability in analgesic and opioid administration for concerns over apnea or desaturation events, and delays awaiting CPAP delivery in patients who left their machines at home. This may direct how OSA patients are handled with regard to PACU care, discharge planning versus overnight admission and in preparation for surgical procedures. For example, only 13% of patients used their CPAP machines postoperatively, and 6% of patients had not brought their CPAP machines with them (despite the institutional policy that all patients are to bring their own CPAP, even for ambula-tory procedures). However, we were unable to quantify through the present retrospective study how many patients diagnosed with OSA actually owned and used CPAP machines at home. Postoperative CPAP use is an area in which potential changes could be made to improve the course of PACU results for OSA patients.

Apnea and desaturation events were noted in 27% of the present cohort, and have been previously reported as a common adverse event for postoperative OSA patients (21). Although the recording of apnea and desaturation events were left to the clinical discretion of the PACU nursing staff, they routinely assess postoperative patients for apnea or desaturations, and typically consider a desaturation as reading <90%. This reference level is generally accepted in the OSA literature (14,24). These adverse respiratory events resulted in significantly longer PACU stays than in patients who did not experience apnea or desatura-tions. The current institutional guideline for PACU monitoring of ambulatory OSA patients at the QEII Health Centre is 4 h (240 min). Patients who experienced apnea and desaturations, and patients whose

course in the PACU were noted by nursing staff to have been adversely affected, both had PACU stays beyond the institutional guidelines (270±135 min and 253±111 min, respectively). This is a considerable issue because OSA patients are placing increased and prolonged demands on PACU beds and staff. Again, use of CPAP postoperatively in the PACU could be beneficial in reducing LOS and additional stress on hospital resources. In addition, close monitoring and careful anesthetic management of these patients may help reduce the number of apnea and desaturation events in the PACU.

One other significant concern surrounding OSA in the literature relates to the need for preoperative diagnosis (19,20). The present study, however, found that a confirmed diagnosis of OSA had no effect on the PACU LOS compared with the suspected OSA group without a confirmed diagnosis. Although no significant difference was found, a confirmed diagnosis of OSA – or careful preoperative screening – may help in preparation for potentially difficult intubation or airway man-agement and postoperative management and, therefore, should still be taken into consideration.

The present study had some potential limitations. First, it is pos-sible that there was an incomplete capture of all OSA patients pro-cessed through the PACU within the study time frame. Although measures were taken to create as complete a dataset as possible, there may have been some cases that were missed if a confirmed or suspected OSA diagnosis had not been elicited by the anesthesiologist or nurse. Further research in this area with larger study groups would help to support the findings of the present study. In addition, there may be an unintentional bias in delaying PACU discharge due to a known or suspected OSA diagnosis. There may be a tendency to retain OSA patients in the PACU for longer periods of time, especially because the potential for an adverse event is common.

COnClUSIOnThe present study observed surgical OSA patients in terms of method and ease of airway management, as well as PACU LOS and OSA-related adverse events. OSA patients had more difficult airway views compared with the rates reported for the general population. Symptomatic OSA patients placed increased demands on the PACU in terms of LOS and hospital resources. Postoperative CPAP use was limited and apnea or desaturation in the PACU was common. This resulted in increased PACU LOS, often beyond the institutional guideline of 4 h (240 min).

aCKnOWlEDgEMEnTS: All authors were involved in most aspects of the research, analysis of the data and writing/editing of the manuscript.

DISClOSURES: No funding was received for this study. The authors have no financial disclosures or conflicts of interest to declare.

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6. Finkel KJ, Searleman AC, Tymkew H, et al. Prevalence of undiagnosed obstructive sleep apnea among adult surgical patients in an academic medical center. Sleep Med 2009;10:753-8.

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complementary and alternative medicine: a survey of its use in children with chronic respiratory illness

Ellison Richmond MPH1,2, Denise Adams PhD3, Simon Dagenais DC PhD4, Tammy Clifford PhD5, Lola Baydala MD MSc FRCPC6, W James King MD FRCPC MSc7, Sunita Vohra MD MSc FRCPC FCAHS2,3

1School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia; 2Department of Pediatrics; Faculty of Medicine and Dentistry; 3CARE Program, Department of Pediatrics, University of Alberta, Edmonton, Alberta; 4Palladian Health, West Seneca, New York, USA; 5Departments of Pediatrics, and Epidemiology & Community Medicine, University of Ottawa, Ottawa, Ontario; 6Department of Pediatrics; Faculty of Medicine and Dentistry; University of Alberta, Edmonton, Alberta; 7Division of Pediatric Medicine, Department of Pediatrics, University of Ottawa, Ottawa, Ontario

Correspondence: Dr Sunita Vohra, Edmonton General Hospital, 8B19-11111 Jasper Avenue, Edmonton, Alberta T5K 0L4. Telephone 780-342-8592, fax 780-342-8464, e-mail [email protected]

Complementary and alternative medicine (CAM) is broadly defined as healing ideas and practices separate from and comple-

mentary to ‘conventional’ medicine (1). Examples include natural health products (also known as dietary supplements), massage and acupuncture. CAM use has been shown to be increasing in both adult and pediatric populations (2,3). CAM use has been variably linked to ethnicity/race, income and education, and severity of health concerns (3).

In Canada, a nationwide survey in 2006 found that 15% of chil-dren had used CAM in the previous year. (4). Similarly, a recent United States study reported that 12% of children had used CAM in the previous year (3); however, use appears to be much higher in chil-dren with chronic health concerns (5). CAM use was reported by 54% of patients of a general pediatric clinic (6) and by 64% of a pediatric rheumatology clinic (7). As the most common chronic disease among children, asthma appears to be associated with significant CAM use (6). While no major Canadian study investigating the epidemiology of CAM use in pediatric asthma has been published, American surveys of

this population have found that the prevalence of lifetime CAM use ranges from 51% to 89% (8,9).

Concerns have been raised about the potential for interactions between CAM and prescription medications, especially in pediatric patients (10,11). Meanwhile, providers may be dangerously ignorant of their patients’ CAM use because parents often do not disclose CAM practices of their children, and physician acknowledgement and chart-ing of these is often deficient (12,13). Thus, there is an urgent need to investigate the pediatric use of CAM in Canada. Better understanding of which CAM modalities are used, why or why they are not used, and patients’ sources of CAM information may inform patient manage-ment and may guide future research into the determinants and effects of CAM use.

The present article focuses on CAM use in pediatric respiratory clinics in Edmonton (Alberta) and Ottawa (Ontario), examining the characteristics of caregivers and children, opinions/beliefs about CAM, use of CAM and sources of information regarding CAM.

original article

E Richmond, D adams, S Dagenais, et al. Complementary and alternative medicine: a survey of its use in children with chronic respiratory illness. Can J Respir Ther 2014;50(1):27-32.

BaCKgROUnD: The use of complementary and alternative medicine (CAM) has increased in recent years, with especially high prevalence in individuals with chronic illnesses. In the United States, the prevalence of CAM use in pediatric asthma patients is as high as 89%. OBJECTIVE: To investigate the epidemiology of pediatric CAM use in respiratory subspecialty clinics. METHODS: A survey was conducted at two hospital-based respiratory clinics in Edmonton (Alberta) and Ottawa (Ontario). Caregivers (most often parents) of children <18 years of age were asked questions regarding child and caregiver use of CAM, including products and practices used, beliefs about CAM, trust in information sources about CAM and charac-teristics of the respondents themselves. RESUlTS: A total of 202 survey questionnaires were completed (151 from Edmonton and 51 from Ottawa). Pediatric CAM use in Edmonton was 68% compared with 45% in Ottawa, and was associated with caregiver CAM use, poorer health and health insurance coverage for CAM. The majority (67%) of children using CAM had taken prescription drugs con-currently and 58% of caregivers had discussed this with their doctor. DISCUSSIOn: Lifetime use of CAM at these pediatric clinics was higher than reported for children who do not have chronic diseases. CAM prac-tices that are popular may be worthy of further research to evaluate their effectiveness and safety profile with regard to drug interactions. Health care providers should be encouraged to discuss CAM use at every visit, and explore their patient’s health-related beliefs, behaviours and treatment preferences.

Key Words: Asthma, Complementary medicine; Cystic fibrosis; Pediatrics; Respiratory illness; Survey

Sondage de l’utilisation de la médecine complémentaire et parallèle chez des enfants atteints d’une maladie respiratoire chronique

HISTORIQUE : L’utilisation de la médecine complémentaire et parallèle (MCP) a augmenté ces dernières années. Sa prévalence est particulièrement élevée chez les personnes atteintes d’une maladie chronique. Aux États-Unis, sa prévalence chez les patients asthmatiques d’âge pédiatrique atteint les 89 %.OBJECTIF : Examiner l’épidémiologie de l’utilisation de la MCP en pédiatrie dans des cliniques spécialisées en santé respiratoire. MÉTHODOlOgIE : Les chercheurs ont effectué un sondage dans deux cli-niques de santé respiratoire en milieu hospitalier, à Edmonton (Alberta) et à Ottawa (Ontario). Les personnes qui s’occupaient d’enfants de 18 ans ou moins (en général, les parents) se sont fait poser des questions sur l’utilisation de la MCP par l’enfant et par elles, y compris les produits et pratiques utilisés, les croyances au sujet de la MCP, la confiance envers les sources d’information sur la MCP et leurs caractéristiques personnelles.RÉSUlTaTS : Au total, 202 sondages ont été remplis (151 à Edmonton et 51 à Ottawa). L’utilisation de la MCP en pédiatrie à Edmonton s’élevait à 68 %, et à 45 % à Ottawa. Elle s’associait à l’utilisation de MCP par la personne qui s’occupait de l’enfant, à une moins bonne santé et à une couverture d’assurance pour la MCP. La majorité des enfants (67 %) qui utilisaient la MCP prenaient simultanément des médicaments sur ordonnance, et 58 % des personnes qui s’occupaient d’eux en avaient parlé avec leur médecin. EXPOSÉ : À ces cliniques de pédiatrie, l’utilisation générale de MCP était plus élevée que celle déclarée chez les enfants qui n’ont pas de maladie chro-nique. Les pratiques de MCP qui sont populaires devraient peut-être faire l’objet de recherches supplémentaires pour en évaluer l’efficacité et le profil d’innocuité en matière d’interactions médicamenteuses. Il faut encourager les dispensateurs de soins à parler de MCP à chaque rendez-vous et à explorer les croyances de leurs patients liées à la santé, leurs comportements et leurs pré-férences thérapeutiques.


Richmond et al


METHODS The present article describes part of a larger study that was performed at the Stollery Children’s Hospital (Stollery) in Edmonton, Alberta, and the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa, Ontario. Five pediatric subspecialty clinics (cardiology, gastroenterol-ogy, neurology, oncology and respiratory) were selected as sites for the larger study and patients in these clinics were surveyed at each of the two hospitals.

Pediatric patients and their families were eligible to participate if they were <18 years of age and could read French or English. All fam-ilies were approached in the waiting room of each participating clinic before their appointment. Research assistants remained in the waiting room to answer questions and collect the completed questionnaires. Surveys were anonymous and, to prevent duplicate surveys, partici-pants were asked by the research assistant if they had previously com-pleted a survey for the present study.

At the time of the present study, no standard survey tool existed for assessing pediatric CAM use and, therefore, the authors’ team developed a survey for use by all participants regardless of specialty or setting. The final version contained 19 questions that addressed patient and family demographics, health status, current and lifetime use of specific CAM products and therapies, reasons for use, use of CAM concurrently with conventional medicine, satisfaction with conventional care, adverse effects and disclosure about CAM use. Questions were informed by previous CAM use surveys and literature reviews of CAM products and practices commonly used by children, and were intended to address gaps in knowledge of CAM use in chil-dren. The survey was piloted for concept validity and revised as needed. The final English-language survey was translated into French and then back translated into English to verify the translation. The French version of the survey was also pilot tested.

Data were entered into SPSS version 11 (IBM Corporation, USA). Descriptive statistics were tabulated as means ± SD or medians (inter-quartile range) for continuous variables, and frequencies and percent-ages for categorical variables. The following participant variables were compared according to centre (Stollery versus CHEO) using Wilcoxon tests, independent t tests and χ2 tests as appropriate: demographics, general health and use of specific CAM products and practices, satis-faction with care and opinions/beliefs about CAM including helpful-ness of CAM, information needs and trust in information sources, and reasons for not using CAM.

Comparison of CAM use between the centres was modelled by univariate and multivariable logistic regression; predictor variables included child’s age, ethnicity, sex, health status, time since diagnosis as well as family’s use of CAM, family’s CAM insurance, parent’s edu-cation and income, and discussion of CAM with conventional med-ical practitioner. Regression diagnostics and measures for detecting outliers and influential observations were peformed. The full methods are described in Adams et al (14).

Ethics approval was granted by the CHEO and Stollery Research Ethics Boards.

RESUlTSCompleted surveys were obtained for 202 pediatric respiratory patients (n=151 from Edmonton and n=51 from Ottawa). Of the 215 families approached, only 12 declined; one survey was excluded because the respondent completed the survey for multiple children rather than one per child. The most common reasons for visiting the respiratory clinics were asthma (n=84 [41.6%]), cystic fibrosis (n=24 [11.9%]) and other respiratory disorders (n=31 [15.3%]).

Population characteristicsPediatric patients sampled were 42.1% female, with a mean age of 7.3 years (6.9 years in Edmonton; 8.5 years in Ottawa; P=0.049) (Table 1). More than one-half reported their ethnicity as Caucasian (55.2%) with others identifying as French Canadian (30.9%), First Nations/Inuit/Métis (11.9%), South Asian (3.1%), East Asian (4.6%),

Black (2.6%), Middle Eastern/Arabic (1.5%) and Latin American/Mexican (1.0%).

Child CAM use was 61.9% (Edmonton 67.5%; Ottawa 45.1%; P=0.004). The questionnaire was administered >12 months after the patient’s diagnosis (58.1%) and most (61.0%) were at the clinic for a routine follow-up without treatment or ongoing treatment (26.2%). Child health was positive (‘excellent’ [12.4%], ‘very good’ [34.2%] and ‘good’ [40.6%]) compared with ‘fair’ (10.4%) and ‘poor’ (2.5%).

Mean parent/caregiver age was 36.2 years in Edmonton and 39.9 years in Ottawa (P=0.024) (Table 1). Respondents were predominantly female (85.1%), 97.5% were the primary caregiver and 80.5% were the mother of the patient. Most described their health as ‘excellent’ (32.0%), ‘very good’ (46.2%) or ‘good’ (20.3%). Significantly more caregivers in Ottawa than Edmonton had a university degree (34.7% versus 17.6%; P=0.012), but household incomes did not differ, with most (75.8%) respondents earning >$40,000 annually. Most (91.9%) caregivers said they would know if the child had used CAM. Fewer than one-half (42.3%) said the child’s CAM costs could be reim-bursed by a private health insurance plan, 33.8% said they could not and 23.9% said they were not sure. Most caregivers reported “don’t know enough about CAM” (60.3%) as a reason for the child not using CAM, or “don’t think CAM is necessary” (20.5%) and “worried about side effects from mixing CAM with other treatments from my doctor” (10.3%). Caregiver CAM use was 67.0% and was not significantly dif-ferent between Edmonton and Ottawa. Reasons for lack of use were similar to those reported for pediatric use.

In Edmonton, multivariable models showed that patients with ‘poor’ or ‘fair’ health status had higher odds of using CAM as those with ‘good’ to ‘excellent’ health (adjusted OR 5.2 [95% CI 1.3 to 20.4]; P=0.02). Edmonton patients with health insurance coverage for CAM had 3.4 (1.4 to 8.3; P=0.009) times greater odds of using CAM than those without coverage, while adjusting for other factors in the model. In Edmonton, children of caregivers who used CAM them-selves had 4.2 (95% CI 1.8 to 9.5; P<0.001) increased odds of using CAM compared with children whose caregivers do not use CAM. In Ottawa, models showed that children of caregivers who use CAM had 11.4 (95% CI 2.7 to 48.2; P<0.001) times greater odds of using CAM than children whose caregivers do not use CAM. No other variables were predictive of CAM use in Ottawa patients.

Products and practicesMost respondents reported pediatric use of some type of vitamin or mineral-type CAM products (85.6%), with more Edmonton than Ottawa patients having ever used multivitamins (80.2% versus 59.1%; P=0.036) (Table 2). Calculation of overall CAM use excluding multi-vitamins/minerals decreased CAM use rate from 61.9% to 52.5%.

Fewer Edmonton than Ottawa patients had ever used herbal-type CAM products (22.9% versus 50.0%; P=0.011) including echinacea (11.5 versus 45.5%; P<0.001), probiotics (acidophilus) (20.8% versus 45.5%; P=0.017), fish oil/omega 3s (14.6% versus 40.9%; P=0.014), flax oil (6.3% versus 31.8%; P=0.003) and green food powder (2.1% versus 18.2%; P=0.011). Slightly more than one-third (38.1%) of all respondents had ever used homeopathic products. Regarding current use, approximately three-quarters (75.9%) of patients were currently using some type of vitamin and mineral-type CAM product, especially multivitamins (64.6%), herbal products (13.9%) and homeopathy (7.6%) (Table 2).

While the most common CAM practices ever used by patients included chiropractic (45.7%), massage (34.3%), aromatherapy (28.6%), faith healing (18.6%), relaxation (14.3%), homeopathy (12.9%) and acupuncture (10.0%), CAM practices currently used by patients included massage (40.0%), aromatherapy (37.1%), chiroprac-tic (22.9%), faith healing (17.1%), relaxation (14.3%) and energy healing (11.4%). Most of the identified CAM products and practices were perceived to be helpful by the respondents and very few reported receiving no help from them (Table 2).

CaM use in children with chronic respiratory illness


Safety issues: Concurrent medication use, side effectsMost (66.7%) patients who used CAM products had done so while concurrently taking prescription medications (Edmonton 62.6% ver-sus Ottawa 85.7%; P=0.042). Slightly more than one-half (57.0%) of caregivers said this was discussed with a doctor, 22.8% with a pharma-cist and 15.2% with other individuals; 22.8% did not report talking to anyone about this.

More than one-half of respondents used some form of CAM (prod-uct or practice) at the same time as conventional medicine (54.6%) as opposed to before (8.3%) or after conventional medicine was success-ful (2.8%), or was not successful (6.5%). One-fifth (21.3%) of respondents reported that the timing of use depended on the type of CAM or reason for use. Of those using CAM and conventional medi-cine concurrently, 53.6% were using more than one prescription drug

at a time, while 34.8% reported using more than one type of CAM at a time. CAM products most commonly used concurrently with pre-scribed conventional therapeutics were vitamins and minerals (65.2%), herbals (24.6%) and homeopathic remedies (10.1%). Concurrent CAM-drug use was most common for anti-asthmatic agents (52.2%), antibiotics (34.8%) and nasal corticosteroids (21.7%) (Table 3).

Few side effects of CAM products or practices were reported. Six minor side effects were reported, in association with calcium, garlic, cold remedies and chiropractic. Two moderate side effects were reported in association with chiropractic and one severe harm was reported in association with the use of magnets. Details of the side effects were not reported by participants.

TaBle 1Demographic information

edmonton, alberta Ottawa, OntarioTotal, n (%)n n (%) n n (%)

Patient informationChild/youth age*, years, mean ± SD 151 6.9±4.3 51 8.5±5.0 7.3±4.5Female sex 151 61 (40.4) 51 24 (47.1) 85 (42.1)Time since diagnosis, months 147 51 0–3 30 (20.4) 6 (11.8) 36 (18.2) 3–6 18 (12.2) 4 (7.8) 22 (11.1) 6–12 18 (12.2) 7 (13.7) 25 (12.6) >12 81 (55.1) 34 (66.7) 115 (58.1)Reason for clinic visit 146 49 Routine follow-up 87 (59.6) 32 (65.3) 119 (61.0) Diagnostic testing 9 (6.2) 3 (6.1) 12 (6.2) Ongoing treatment 40 (27.4) 11 (22.4) 51 (26.2) New condition 2 (1.4) 2 (4.1) 4 (2.1) Other 8 (5.5) 1 (2.0) 9 (4.6%)Health status 151 51 Excellent 16 (10.6) 9 (17.6) 25 (12.4) Very good 48 (31.8) 21 (41.2) 69 (34.2) Good 65 (43.0) 17 (33.3) 82 (40.6) Fair 19 (12.6) 2 (3.9) 21 (10.4) Poor 3 (2) 2 (3.9) 5 (2.5)CAM insurance, yes 150 63 (42.0) 51 22 (43.1) 85 (42.3)Child/youth has ever used CAM†, yes 151 102 (67.5) 51 23 (45.1) 125 (61.9)Parent/caregiver informationParent/caregiver age‡, years, mean ± SD 149 36.2 (7.1) 50 39.9 (9.0) 37.2 (7.8)Female sex 151 130 (86.1) 50 41 (82.0) 171 (85.1)Highest completed level of education 148 49 No formal education 1 (0.7) 0 (0) 1 (0.5) Primary school only 3 (2.0) 0 (0) 3 (1.5) Secondary (high) school 35 (23.6) 11 (22.4) 46 (23.4) Registered apprenticeship or other trade 12 (8.1) 0 (0) 12 (6.1) College, CEGEP or other nonuniversity 53 (35.8) 17 (34.7) 70 (35.5) University, without university degree 13 (8.8) 4 (8.2) 17 (8.6) University, with university degree§ 26 (17.6) 17 (34.7) 43 (21.8) Other 5 (3.4) 0 (0) 5 (2.5)Annual household income, $ 141 49 <10,000 2 (1.4) 2 (4.1) 4 (2.1) 10,000 to 19,000 11 (7.8) 3 (6.1) 14 (7.4) 20,000 to 39,000 20 (14.2) 8 (16.3) 28 (14.7) 40,000 to 79,999 44 (31.2) 19 (38.8) 63 (33.2) ≥80,000 64 (45.4) 17 (34.7) 81 (42.6)Respondent had ever used CAM, yes 150 105 (70.0) 50 29 (58.0) 134 (67.0)

n Number with valid responses; *Child/youth mean age was significantly higher in Ottawa, Ontario (P=0.0492); †Child use of complementary and alternative medi-cine was significantly higher in Edmonton, Alberta (P=0.043); ‡Parent age was significantly higher in Ottawa (P=0.024); §A significantly higher percentage of parent/caregivers in Ottawa had university, with a university degree (P=0.012). CEGEP Collège d’enseignement général et professionnel

Richmond et al


Sources of information The most commonly used sources of information (in descending order of frequency) regarding CAM were: family/friends (65.1%), books (39.6%), health food stores (36.8%), pharmacy (34.9%), Internet (29.2%), CAM health providers (28.3%), the hospital clinic (27.4%) and conventional health providers (26.4%). The most trusted sources of information on CAM (rated on a 10-point scale) were conventional health providers (mean [± SD] 8.4±1.6), the hospital clinic (8.2±2.1), the pharmacy (8.0±1.7) and CAM health providers (7.6±2.5).

The majority of caregivers reported ‘strongly agreed’ (33.2%) or ‘agreed’ (42.7%) in response to “I feel comfortable discussing CAM use in this clinic”. Most also ‘strongly agreed’ (21.1%) or ‘agreed’ (40.7%) with “I would like more information on CAM from this clinic.”

DISCUSSIOn The present survey sheds light on the use of CAM by pediatric respira-tory disease patients and the characteristics of its users and their parents/caregivers. As the first multicentre survey of this population in Canada, it may inform both caregivers and researchers in improving care and focusing further research.

While child lifetime CAM use differed significantly between patients in Edmonton and Ottawa (67.5% versus 45.1%, respectively; P<0.004), these values are consistent with other studies investigating pediatric chronic illness (5,9). These values also suggest regional/geo-graphical differences within similar patient populations; however, our survey did not identify reasons for these regional differences.

As expected, child CAM use was strongly correlated with caregiver CAM use, which suggests that its use is tied to caregiver health-related

beliefs, values and preferences. As in similar studies, poorer health status was related to CAM use (13). Parents, especially of children with chronic illness, may seek CAM after becoming dissatisfied with conventional therapy and its effects. It may be regarded as a ‘second chance’ at effective treatment and may be a way for parents to gain control over difficult-to-manage situations (15).

Two-thirds of patients in the present study used prescription medi-cine at the same time as CAM products and many did not discuss this with their physician or pharmacist. Concurrent use is not necessarily hazardous and, while most respondents did not report experiencing harm, given the frequency of concurrent use, more data demonstrating the safety of this practice are urgently needed. It has been suggested that several of the CAM products most popular with the study group can interact adversely with other CAM and conventional practices. Vitamin C with acetaminophen, vitamins D, B6, B9 and B12 with cor-ticosteroids, and vitamins B3, E and folic acid with ibuprofen have potential to interact, among countless combinations (11). Such com-binations are not rare; a large Toronto emergency department survey of CAM and conventional medication use identified potential inter-action in 16% of surveyed children (11). As such, physicians and other health care providers should inquire about and record history of CAM use routinely during patient visits. Some drug-natural health product combinations may, in fact, be helpful; for example, studies have suggested that probiotics may be effective in preventing antibiotic-associated diarrhea (16,17). Patient safety depends on disclosure and discussion of all health practice and our concern is not that patients use natural health products to improve their health, but that they do so without disclosure.

TaBle 2Commonly used products/practices and their perceived helpfulness

Productever used (n=118)

Current use (n=79)

Perceived helpfulnessn Yes No Maybe

Vitamins and minerals 101 (85.6) 60 (75.9) Calcium 16 (13.6) 8 (10.1) 14 10 (71.4) 0 (0) 4 (28.6) Folic acid 4 (3.4) 2 (2.5) 2 2 (100.0) 0 (0) 0 (0) Vitamin B 6 (5.1) 3 (3.8) 6 5 (83.3) 0 (0) 1 (16.7) Vitamin C 32 (27.1) 16 (20.3) 30 17 (56.7) 1 (3.3) 12 (40.0) Multivitamin/mineral 90 (76.3)* 51 (64.6) 78 42 (53.8) 3 (3.8) 33 (42.3)Herbals 33 (28.0) 11 (13.9) Echinacea 21 (17.8)‡ 5 (6.3) 18 11 (61.1) 0 (0) 7 (38.9) Garlic 12 (10.2) 6 (7.5) 11 9 (81.8) 0 (0) 2 (18.2) Ginseng 4 (3.4) 1 (1.3) 3 2 (66.7) 0 (0) 1 (33.3) Peppermint 10 (8.5) 3 (3.8) 9 8 (88.9) 0 (0) 1 (11.1)Homeopathics 45 (38.1) 6 (7.6) Cold remedy 19 (16.1) 3 (3.8) 16 11 (68.8) 2 (12.5) 3 (18.8) Colic remedy 15 (12.7) 1 (1.3) 11 7 (63.6) 1 (9.1) 3 (27.3) Ear drops 11 (9.3) 1 (1.3) 9 7 (77.8) 1 (11.1) 1 (11.1) Teething remedy 20 (16.9) 1 (1.3) 15 14 (93.3) 0 (0) 1 (6.7)Miscellaneous 51 (42.3) 27 (34.2) Fish oil/omega 3s 23 (19.5)† 11 (13.9) 20 13 (65.0) 2 (10.0) 5 (25.0) Flax oil 13 (11.0)‡ 9 (11.4)† 10 6 (60.0) 0 (0) 4 (40.0) Green food powder 6 (5.1)† 0 (0) 5 1 (20.0) 2 (20.0) 3 (60.0) Probiotics 30 (25.4)† 8 (10.1) 26 18 (69.2) 1 (3.8) 7 (26.9)Practice n=70 n=35Acupuncture 7 (10.0) 0 (0) 6 5 (83.3) 0 (0) 1 (16.7)Aromatherapy 20 (28.6) 13 (37.1) 18 11 (61.1) 0 (0) 7 (38.9)Chiropractic 32 (45.7) 8 (22.9) 27 18 (66.7) 2 (7.4) 7 (25.9)Energy healing 6 (8.6) 4 (11.4) 5 2 (40.0) 0 (0) 3 (60.0)Faith healing 13 (18.6) 6 (17.1) 12 11 (91.7) 0 (0) 1 (8.3)Homeopathy 9 (12.9) 2 (5.7) 7 6 (85.7) 1 (14.3) 0 (0)Massage 24 (34.3) 14 (40.0) 22 18 (81.8) 0 (0) 4 (18.2)Relaxation 10 (14.3) 5 (14.3) 9 8 (88.9) 0 (0) 1 (11.1)

Data presented as n (%) unless otherwise indicated. *Edmonton (Alberta) use greater than Ottawa (Ontario) use (P<0.05); †Ottawa use greater than Edmonton use (P<0.05); ‡Ottawa use greater than Edmonton use (P<0.01)

CaM use in children with chronic respiratory illness


Aside from being able to advise about positive and negative inter-actions, understanding CAM use can improve the ability of health professionals to deliver patient- and family-oriented care. While most patients in the present study reported that CAM was helpful and that they felt comfortable discussing their CAM use in the clinic, phys-icians have been shown, in many cases, to be dismissive of CAM and negligent in recording its use by their patients (12). Patient-centred care demands that health care practitioners learn about their patient’s health care beliefs and preferences (18). Beliefs about CAM and its effectiveness, especially compared with biomedical approaches, can impact adherence to prescribed therapy. For example, when respiratory disease therapy is perceived by patients to be ineffective or inappropri-ate, adherence can diminish (19).

Generalizability of the present study is limited by the selection of patients speaking either English or French, and attending one of two urban hospital-based clinics. The ability to recall the use of CAM may be limited, especially via a proxy (caregiver on behalf of a child), and responses may have been biased by expectations of desired responses. Finally, the present survey was not conducted over a full calendar year; there may be seasonal factors affecting the patients attending clinics and/or the use of CAM.

However, the present study does lay important groundwork. The CAM used by these patients may direct research on the motivation for their use and the dynamic between CAM and conventional therapy. The specific products and practices identified to be popular may be targets for more focused research on effectiveness and/or interaction with medications typical for pediatric respiratory patients. Ultimately,

a better understanding of why patients seek CAM and the effects of its use may improve our ability to effectively work with patients and bet-ter support their health decisions.

aCKnOWlEDgEMEnTS: The authors thank Adam Gruszczynski (CHEO Research Assistant) Deepika Mittra (Edmonton Research Assistant), Marilou Hervas-Malo (Biostatistician) and Melba Baylon for their assistance in the study. The authors gratefully thank the clinic direc-tors and staff from participating clinics for their support of the study.

DISClOSURES: The authors have no financial disclosures or conflicts of interest to declare.

FUnDIng: This project was supported by a grant from the SickKids Foundation. Sunita Vohra receives salary support from Alberta Innovates-Health Solutions (formerly Alberta Heritage Foundation for Medical Research).

aUTHORSHIP: Each of the authors met the criteria for authorship established by the ICMJE. Each author contributed substantially to con-ception and design, acquisition of data, or analysis and interpretation of data; drafting the manuscript or revising it critically for important intel-lectual content; and final approval of the version to be published. Ellison Richmond: Mr Richmond was substantially involved in analysis and inter-pretation of data, drafting and revising the manuscript and final approval of the version to be published. Denise Adams: Dr Adams was substantially involved in analysis and interpretation of data, drafting and revising the

TaBle 3Therapeutics and concurrent complementary and alternative medicine (CaM) use Therapeutic agent(s)* Users, n (%) (n=69) CaM products used concurrently nAnalgesic agents: acetaminophen, codeine, diclofenac, ibuprofen 6 (8.7) Vitamins and minerals 5

Herbals 1Miscellaneous 5Homeopathy 1

Antiasthmatic agents: beclomethasone, budesonide, fluticasone, montelukast salbutamol, terbutaline; budesonide/formoterol, fluticasone/salmeterol

36 (52.2) Vitamins and minerals 28Herbals 8Miscellaneous 8Homeopathy 6

Antibiotics: amikacin, amoxicillin, azithromycin, cephalexin, ciproflaxacin clarithromycin, tobramycin, trimethoprim/sulfamethoxazole


Anti-ulcer agents: lansoprazole, omeprazole, ranitidine, sucralfate 11 (15.9) Vitamins and minerals 6Herbals 2Miscellaneous 3Homeopathy 2

Nasal corticosteroids: budesonide, furoate, mometasone, triamcinolone 15 (21.7) Vitamins and minerals 15Herbals 2Miscellaneous 3Homeopathy 1

Pancreatic enzymes: pancrelipase 8 (11.6) Vitamins and minerals 6Herbals 1Miscellaneous 5Homeopathy 0

Psychostimulants: atomoxetine, caffeine, dextroamphetamine, modafinil, amphetamine/dextroamphetamine


Other: deflazacort, desmopressin, dornase alfa, insulin, peglyte, phenobarbital, prednisone, tamsulosine, valproic acid; brompheniramine/phenylephrine/dextromethorphan (Dimetapp†)


*Listed alphabetically (single products; combinations); †Pfizer, USA

Richmond et al


manuscript and final approval of the version to be published. Simon Dagenais: Dr Dagenais was substantially involved in design and conduct of the study, revising the manuscript and final approval of the article to be published. Tammy Clifford: Dr Clifford was substantially involved in design and conduct of the study, revising the manuscript and final approval of the article to be published. Lola Baydala: Dr Baydala was substantially involved in design of the study, revising the manuscript and final approval

of the article to be published. W James King: Dr King was substantially involved in design of the study, revising the manuscript and final approval of the article to be published. Sunita Vohra: Dr Vohra was substantially involved in design and conduct of the study, interpretation of the data, drafting and revising the manuscript and final approval of the article to be published.

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a definition. Br J Gen Pract 1995;45:506.2. Barnes PM, Powell-Griner E, McFann K, Nahin RL.

Complementary and alternative medicine use among adults: United States, 2002. Semin Integr Med 2004;2:54-71.

3. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 2008;10:1-23.

4. Esmail N. Complementary and Alternative Medicine in Canada: Trends in Use and Public Attitudes, 1997-2006. Public Policy Sources, 2007;87.

5. McCann LJ, Newell SJ. Survey of paediatric complementary and alternative medicine use in health and chronic illness. Arch Dis Child 2006;91:173-4.

6. Jean D, Cyr C. Use of complementary and alternative medicine in a general pediatric clinic. Pediatrics 2007;120:e138-41.

7. Hagen LE, Schneider R, Stephens D, Modrusan D, Feldman BM. Use of complementary and alternative medicine by pediatric rheumatology patients. Arthritis Rheum 2003;49:3-6.

8. Post-White J, Fitzgerald M, Hageness S, Sencer SF. Complementary and alternative medicine use in children with cancer and general and specialty pediatrics. J Pediatr Oncol Nurs 2009;26:7-15.

9. Slader CA, Reddel HK, Jenkins CR, Armour CL, Bosnic-Anticevich SZ. Complementary and alternative medicine use in asthma: Who is using what? Respirology 2006;11:373-87.

10. Gardiner P, Phillips R, Shaughnessy AF. Herbal and dietary supplement – drug interactions in patients with chronic illnesses. Am Fam Physician 2008;77:73-8.

11. Goldman RD, Rogovik AL, Lai D, Vohra S. Potential interactions of drug-natural health products and natural health products-natural health products among children. J Pediatr 2008;152:521-6.

12. Cockayne NL, Duguid M, Shenfield GM. Health professionals rarely record history of complementary and alternative medicines. Br J Clin Pharmacol 2005;59:254-8.

13. Sidora-Arcoleo K, Yoos HL, Kitzman H, McMullen A, Anson E. Don’t ask, don’t tell: Parental nondisclosure of complementary and alternative medicine and over-the-counter medication use in children’s asthma management. J Pediatr Health Care 2008;22:221-9.

14. Adams D, Dagenais S, Clifford T, et al. Complementary and alternative medicine use by pediatric specialty outpatients. Pediatrics 2013;131:225-32.

15. Committee on Children with Disabilities. American Academy of Pediatrics: Counseling families who choose complementary and alternative medicine for their child with chronic illness or disability. Pediatrics 2001;107:598-601.

16. Cremonini F, Di Caro S, Nista E, et al. Meta-analysis: The effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther 2002;16:1461-7.

17. D’Souza A, Rajkumar C, Cooke J, Bulpitt C. Probiotics in prevention of antibiotic associated diarrhoea: Meta-analysis. BMJ 2002;324:1361.

18. Pulvrenti M, McMillan J, Lawn S. Empowerment, patient centred care and self management. Health Expect. 2012 Jan 2. doi: 10.1111/j.1369-7625.2011.00757.x. (Epub ahead of print)

19. Horne R, Price D, Cleland J, et al. Can asthma control be improved by understanding the patient’s perspective? BMC Pulm Med 2007;7:8.

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For more information:Please consult the Product Monograph at www.novartis.ca/SeebriMonograph for important information relating to adverse events, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling the Medical Information department at 1-800-363-8883.

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§ LS mean FEV1 (L) after first dose; SEEBRI* BREEZHALER* (n=169) vs. placebo (n=83), respectively: 5 min: 1.39 vs. 1.30; 15 min: 1.43 vs. 1.28; 30 min: 1.44 vs. 1.28; 1 hr: 1.47 vs. 1.28; 2 hrs: 1.53 vs. 1.34; 3 hrs: 1.53 vs. 1.35; 4 hrs: 1.52 vs. 1.35; 6 hrs: 1.48 vs. 1.33; 8 hrs: 1.47 vs. 1.33; 10 hrs: 1.47 vs. 1.32; 12 hrs: 1.45 vs. 1.31; 23 hrs 15 min: 1.37 vs. 1.27; 23 hrs 45 min: 1.39 vs. 1.31; p<0.001 for all time points.

References: 1. SEEBRI* BREEZHALER* Product Monograph. Novartis Pharmaceuticals Canada Inc., October 12, 2012. 2. Kerwin E, Hébert J, Gallagher N et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J 2012;40:1106-14. 3. D’Urzo A, Ferguson GT, van Noord JA et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res 2011;12:156(1-13). 4. Data on file. Novartis Pharmaceuticals Canada Inc.5. Jones P. St. George’s Respiratory Questionnaire Manual. Available from: www.healthstatus.sgul.ac.uk/SGRQ_download/SGRQ%20Manual%20June%202009.pdf. Accessed December 5, 2011. 6. Ontario Drug Benefit Formulary, August 29, 2013. 7. RAMQ, June 1, 2013.

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