Chronic Rhinosinusitis 2012

EPOS 2012 POSITION PAPER

European Position Paper on Rhinosinusitis and Nasal Polyps 2012Wytske J. Fokkens, chair a, Valerie J. Lund, co-chair b, Joachim Mullol, co-chair c, Claus Bachert, co-chair d, Isam Alobid c, Fuad Baroody e, Noam Cohen f, Anders Cervin g, Richard Douglas h, Philippe Gevaert d, Christos Georgalas a, Herman Goossens i, Richard Harvey j, Peter Hellings k, Claire Hopkins l, Nick Jones m, Guy Joos n, Livije Kalogjera o, Bob Kern p, Marek Kowalski q, David Price r, Herbert Riechelmann s, Rodney Schlosser t, Brent Senior u, Mike Thomas v, Elina Toskalaw, Richard Voegels x, De Yun Wang y, Peter John Wormald za b c d e Department of Otorhinolaryngology, Academic Medical Center, Amsterdam, the Netherlands Royal National Throat, Nose and Ear Hospital, London, United Kingdom Rhinology Unit & Smell Clinic, ENT Department, Hospital Clnic IDIBAPS, Barcelona, Catalonia, Spain Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium Section of Otolaryngology-Head and Neck Surgery, University of Chicago Medical Center, and the Pritzker School of Medicine, University of Chicago, Chicago, IL, USA f g h i j Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania, PA, USA Department of Otorhinolaryngology, Head and Neck Surgery, Lund University, Helsingborg Hospital, Helsingborg, Sweden Department of Otolaryngology-Head and Neck Surgery, Auckland City Hospital, Auckland, New Zealand Department of Microbiology, University Hospital Antwerp, Edegem, Belgium Rhinology and Skull Base Surgery, Department of Otolaryngology/Skull Base Surgery, St Vincents Hospital, University of New South Wales & Macquarie University, Sydney, Australia k l Department of Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven, Leuven Belgium ENT Department, Guys and St Thomas Hospital, London, United Kingdom Rhinology supplement 23 : 1-298, 2012

m Department of Otorhinolaryngology, Head and Neck Surgery, Queens Medical Centre, Nottingham, United Kingdom n o p q r s t u v Department of Respiratory Medicine, Ghent University, Gent, Belgium Department of Otorhinolaryngology/Head and Neck Surgery, Zagreb School of Medicine, University Hospital Sestre milosrdnice, Zagreb, Croatia Department of Otolaryngology-Head and Neck Surgery Northwestern University Feinberg School of Medicine, Northwestern Memorial Hospital, Chicago, IL, USA Department of Immunology, Rheumatology and Allergy, Medical University of d, d, Poland Academic Centre of Primary Care, University of Aberdeen, Foresterhill Health Centre, United Kingdom Department of Otorhinolaryngology, Medicial University Innsbruck, Innbruck, Austria Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA Department of Otolaryngology-Head and Neck Surgery, Division of Rhinology, University of North Carolina at Chapel Hill, NC, USA Primary Care Research, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, Southampton, United Kingdom

w Center for Applied Genomics, Childrens Hospital of Philadelphia, PA, USA x y z Division of Otorhinolaryngological Clinic at Clinical Hospital of the University of So Paulo, Brazil Department of Otolaryngology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore Department of Surgery-Otolaryngology, Head and Neck Surgery, Adelaide and Flinders Universities, The Queen Elizabeth Hospital, Woodville, South Australia, Australia

European Position Paper on Rhinosinusitis and Nasal Polyps 2012

ConsultantsSurayie H.M. Al Dousary 1, Wilma Anselmo-Lima 2, Tomislav Baudoin 3, Roxanna Cobo 4, Jiannis Constantinidis 5, Hun-Jong Dhong 6, Javier Dibildox 7, Nguyen Dung 8, Jan Gosepath 9 , Mats Holmstrm 10, Maija Hytnen 11, Roger Jankowski 12, Mark Jorissen 13, Reda Kamel 14, Hideyuki Kawauchi 15, David Kennedy 16, Jean Michel Klossek 17, Vladimir Kozlov 18, Heung-Man Lee 19, Donald Leopold 20, Andrey Lopatin 21, Bradley Marple 22, Eli Meltzer 23,Hiroshi Moriyama24, Bob Naclerio 25, Kimihiro Okubo47, Metin Onerci 26, Nobuyoshi Otori 24, Muge Ozcan 27, Jim Palmer 28, Enrique Pasquini 29, Desiderio Passali 30, Chae-Seo Rhee 31, Claudia Rudack 32, Glenis Scadding 33, Elie Serrano 34, Erika Sims 35, Heinz Stammberger 36, Sverre Steinsvg 37, Pongsakorn Tantilipikorn 38, Sanguansak Thanaviratananich 39, De Hui Wang 40, Retno Wardani 41, Geng Xu 42, Jiannis Yiotakis 43, Mario Zernotti 44, Yamei Zhang 45, Bing Zhou 46

1

ENT Department, King Abdulaziz University Hospital, Riyad, Faculty of Medicine, King Saud , Saudi Arabia; 2Department of Ophthalmology, Otorhinolaryngology

and HNS, Faculty of Medicine of Ribeiro Preto- University of So paulo, Paulo, Brasil; 3Department of Otolaryngology-Head and Neck Surgery, Sestre Milosrdnice University Hospital, Zagreb, Croatia; 4Depeartment of Otolaryngology, Centro Medico Imbanaco, Cali, Colombia; 52nd Department of Otorhinolaryngology, Aristotle University, Thessaloniki, Greece; 6Department of Otorhinolaryngology, Sungkyunkwan University, Samsung Medical Center, Korea; 7Service of Otolaryngology. Faculty of Medicine, Autonomus University of San Luis Potosi, and Hospital Central Dr. I. Morones Prieto, San Luis Potosi, Mxico; 8ENT hospital, medical University HCM ville, Ho Chi Minh City, Vietnam; 9Department of Otolaryngology, Head and Neck Surgery, HSK, Dr. Horst Schmidt Kliniken, Academic Hospital University of Mainz ,Wiesbaden, Germany; 10Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden; 11Department of Otorhinolaryngology,Helsinki University Central Hospital, Helsinki, Finland; 12ORL Dept, Universit de Lorraine, Hpital Central, Nancy, France; 13Dienst NKO-GH, UZLeuven, Leuven, Belgium; 14Department of Rhinology, Cairo University, Cairo, Egypt; 15Department of Otorhinolaryngology, Shimane University, Faculty of Medicine, Izumo, Japan; 16Department of Rhinology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 17ENT and Head and Neck Department, University Hospital Jean Bernard Service, ORL, Poitiers Cedex, France; 18Department of Otorhinolaryngology, Central Clinical Hospital under the President of Russian Federation, Moscow, Russian Federation; 19Department of Otorhinolaryngology-Head and Neck Surgery, Korera University College of Medicine, Seoul, Korea; 20Department of Otorhinolaryngology, University of Vermont, Burlington, VM, USA; 21ENT clinic, the First Moscow State Medical University, Moscow, Russian Federation; 22Department of Otolaryngology, University of Texas Southwestern Medical School, Dallas, TX, USA; 23Allergy & Asthma Medical Group & Research Center, University of California, San Diego, San Diego, CA, USA; 24Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan; 25Department of Otolaryngology Head and Neck Surgery, University of Chicago, IL, USA; 26Department of Otorhinolaryngology, Hacettepe University, Ankara, Turkey; 27Department of Otorhinolaryngology, Ankara Numune Education and Research Hospital Otorhinolaryngology Clinic, Ankara, Turkey; 28Division of Rhinology, Dept of ORL:HNS, University of Pennsylvania, Philadelphia, PA, USA; 29ENT department, SantOrsola-Malpighi Hospital, University of Bologna, Bologna, Italy ; 30University of Siena, Italy; 31Department of Otorhinolaryngology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Korea; 32Department Otorhinolaryngology, University Hospital Mnster, Mnster, Germany; 33Department of Allergy & Medical Rhinology , Royal National Throat, Nose and Ear Hospital, London, United Kingdom; 34Department of Otorhinolaryngology Head and Neck Surgery, Larrey University Hospital, Toulouse, France; 35Research in Real Life Ltd, Oakington, Cambridge, UK and Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK; 36Department of General Otorhinolaryngology-Head and Neck Surgery, Medical University Graz, Austria; 37Department. of ORL, Srlandet Hospital, Kristiansand and Haukeland University Hospital, Bergen, Norway; 38Rhinology and Allergy Division, Mahidol University, Siriraj Hospital, Bangkok, Thailand; 39Department of Otorhinolaryngology, Khon Kaen University, Khon Kaen, Thailand;40

Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China; 41Rhinology Division - ENT Department, Faculty of Medicine

University of Indonesia, Dr. Cipto Mangunkusumo Hospital, Jakarta; 42Otorhinolaryngology Hospital of The first Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China; 43Otorhinolaryngology Department, Athens University, Ippokration General Hospital, Athens, Greece; 44ENT Department, School of Medicine, Catholic University of Crdoba, Cordoba, Argentina; 45Department of ENT, Beijing Childrens Hospital Affiliate of Capital Medical University, Beijing, China; 46Department of Otolaryngology-Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China; 47 Department of Otolaryngology, Nippon Medical School, Tokyo, Japan.

AknowledgementsThe EPOS2012 group express their gratitude to Marjolein Cornet, Tanja van Ingen, Judith Kosman en Christine Segboer for helping with the preparation of this document and they thank Bionorica, the European Academy of Allergy and Clinical Immunology, the European Rhinologic Society, Grupo Uriach, Hartington, Medtronic, Neilmed, Sanofi and Regeneron for their unrestricted support.

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Supplement 23

ContentsAbbreviations 1 2. 3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 4. 4.1. 4.2. 4.3. 4.4. 4.5. 5. 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7. 6. 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. Introduction Classification and Definitions Acute rhinosinusitis (ARS) Epidemiology and predisposing factors of ARS Pathophysiology of ARS Diagnosis and Differential Diagnosis of ARS Management of ARS Complications of ARS Paediatric ARS Chronic Rhinosinusitis with or without nasal polyps (CRSwNP or CRSsNP) Epidemiology and predisposing factors Inflammatory mechanisms in chronic rhinosinusitis with or without nasal polyposis Diagnosis Facial pain Genetics of CRS with and without nasal polyps Special items in Chronic Rhinosinusitis Complications of Chronic Rhinosinusitis Chronic Rhinosinusitis with or without NP in relation to the lower airways Cystic fibrosis Aspirin exacerbated respiratory disease Immunodeficiencies and Chronic Rhinosinusitis Allergic fungal rhinosinusitis Paediatric Chronic Rhinosinusitis Management, reasons for failure of medical and surgical therapy in Chronic Rhinosinusitis Treatment of CRSsNP with corticosteroids Treatment of CRSsNP with antibiotics Other medical management in CRSsNP Evidence based surgery for CRSsNP Treatment with corticosteroids in CRSwNP Treatment CRSwNP with antibiotics 1 3 5 9 9 16 24 30 42 48 6.7. 6.8. 6.9. Other medical management in CRSwNP Evidence based Surgery for CRSwNP Influence of concomitant diseases on outcome of treatment in Chronic Rhinosinusitis with and without NP including reasons for failure of medical and surgical therapy 6.10. Management of Paediatric Chronic Rhinosinusitis Burden of Rhinosinusitis Quality of Life measurements in the diagnosis and outcome measurement of CRS with and without NP Direct Costs Indirect Medical Costs Evidence based schemes for diagnostic and treatment Introduction Evidence based management for adults with acute rhinosinusitis Evidence based management for children with acute rhinosinusitis for primary care Evidence based management for adults and children with acute rhinosinusitis for ENT specialists Evidence based management scheme for adults with chronic rhinosinusitis Evidence based management for children with Chronic Rhinosinusitis Research needs and search strategies Introduction Classification and Definitions Acute rhinosinusitis Chronic rhinosinusitis with or without NP CRSwNP and CRSsNP in relation to the lower airways Paediatric Chronic Rhinosinusitis Management of CRSwNP and CRSsNP References 181 187

191 196 201

7. 7.1.

7.2. 7.3. 8. 8.1. 8.2. 8.3. 8.4

201 204 206

55 55 60 87 95 107 111 111

209 209 210 211

212 213 219 221 221 221 221 222 223 223 223 225

8.5 115 117 124 128 130 131 8.6.

139 139 148 152 154 158 180

9. 9.1. 9.2. 9.3. 9.4. 9.5. 9.6. 9.7. 10.


Supplement 23

Abbreviations12-LO 15-HETE AAO-HNS ABRS AE AERD AFRS AFS AIDS AIFRS AMCase AML AOAH APC AR. ARS ASA-sensitive ATA BAFF BAL BD BUD CBCT CCL CCR3 CF CFTR CH CI cNOS CNS COPD COX CpG CPH CRP CRS CRSsNP CRSwNP CSS CT CTLs CVID CXCL DAMP DBPC DC DM DMBT1 ECM 12-Lipoxygenase 15-Hydroxyeicosatetraenoic acid American Academy of Otolaryngology-Head and Neck Surgery Acute bacterial rhinosinusitis Adverse event Aspirin Exacerbate Respiratory Disease Allergic fungal rhinosinusitis Allergic fungal sinusitis Acquired Immunodeficiency Syndrome Acute invasive fungal rhinosinusitis Acid mammalian chitinase Acute myeloid leukemia Acyloxyacyl hydrolase Antigen presenting cell Allergic Rhinitis Acute Rhinosinusitis Aspirin sensitive Aspirin tolerant B-cell activating factor Bbronchoalveolar lavages Twice daily Budesonide Cone beam CT CC chemokine ligand C-C chemokine receptor type 3 Cystic fibrosis Cystic Fibrosis Transmembrane Conductance Regulator Cluster headache Confidence interval Constitutive Nitric oxide Central nervous system Chronic Obstructive Pulmonary Disease Cyclooxygenase enzyme CphosphateG Chronic Paroxysmal Hemicrania C-Reactive Protein Chronic rhinosinusitis Chronic Rhinosinusitis without nasal polyps Chronic Rhinosinusitis with nasal polyps Chronic Sinusitus Survey Computed tomography Cytotoxic lymphocytes Common variable immune deficiency CXC chemokine ligand Damage-associated molecular pattern Double-blind placebo-controlled Dendritic cell Diabetes mellitus Malignant brain tumor Extracellular matrix ECP ECs EMMA EMMPRIN EMTU eNOS ENT ES ESR ESS ESSAL FEE FESS FEV1 FOXP3 FP G-CSF GA(2) LEN GAR GB GERD GM-CSF GP GVHD GWAS HC HIF HIV HLA HRQL HSCT i.v. ICAM-1 ICD-9 ICU IFN Ig IHC IHS IL IL-22R INCS iNOS IVIG KCN LO LPS LT MCP MDC MF Eosinophil cationic protein Epithelial cells Endoscopic maxillary mega-antrostomy Extracellular matrix metalloproteinase inducer Epithelial-mesenchymal unit Endothelial NOS Ear Nose and Throat Effect Size Erythrocyte sedimentation rate Endoscopic sinus surgery Endoscopic surgery with serial antimicrobial lavage Functional endoscopic ethmoidectomy Functional Endoscopic Sinus Surgery Forced expiratory volume in one second Forkhead box P3 Fluticasone propionate Granulocyte colony-stimulating factor Global Allergy and Asthma European Network Glucocorticoid receptor Goblet cells Gastroesophageal reflux disease Granulocyte macrophage colony-stimulating factor General Practitioners Graft versus host disease Genome wide association studies Hemicrania continua Hypoxia-inducible factor Human immunodeficiency virus Human leukocyte antigen Health-related quality of life Hematopoietic stem cell transplantation Intravenous Inflammatory adhesion molecule International Classification of Diseases-9 Intensive care unit Interferon Immunoglobulin Immunohistochemistry International Headache Society Interleukin Interleukin-22 Receptor Intranasal corticosteroid Inducible Nitric oxide Intravenous immunoglobulin Key cytokine negative Lipoxygenase Lipopolysaccharides Leukotriene Monocyte chemotactic protein Myeloid dendritic cells Mometasone furoate

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MHC-II MMP MMR MPO MRA mRNA MRSA MSCT MT MUC NAMCS NANC NF-B NK NKT NLR NMDA nNOS NO NOD NOS NP NPV NSAIDs OCS OD OM-85 BV OMC OPN OR PAI-1 PAMP PAR PBMCs PCD PCV7 PDC PDGF PEF PEFR PET PGE2 PGI2 PGP PH PID PIP PKC PLUNC PMN PNIF POSTN PPV

Major histocompatibility complex II Matrix metalloproteinase Macrophage mannose receptor Myeloperoxidase Magnetic resonance angiography Messenger Ribonucleic acid Methicillin-resistant Staphylococcus aureus Multislice CT Middle Turbinate Mucin National Ambulatory Medical Care Survey Non-cholinergic system Nuclear factor kappaB Natural Killer Natural killer T cell NOD-like receptor N-methyl-D-aspartate Neural NOS Nitric oxide Nucleotide Oligomerization Domain Nitric oxide synthase Nasal polyps Negative predictive value Non steroidal anti inflammatory drugs Oral corticosteroid Once daily Oral bacterial lysate Broncho Vaxom Ostio-meatal complex Osteopontin Odds ratio Plasminogen activator inhibitor Pathogen associated molecular patterns Protease-activated receptor Peripheral blood mononuclear cells Primary cilia dyskinesia 7-valent Pneumococcal conjugate vaccine Plasmacytoid dendritic cells Platelet-derived growth factor Pulmonary expiratory flow Peak expiratory flow rate Positron emission tomography Prostaglandin E2 Prostacyclin N-acetyl Pro-Gly-Pro Paroxysmal Hemicrania Primary immunodeficiencies Prolactin-induced protein Protein kinase C Palate Lung Nasal Epithelial Clone Polymorphonuclear neutrophils Peak nasal inspiratory flow Periostin Positive predictive value

PROMS PRR PSP QOL RANTES RAST test RCT RNS ROS RR RSDI RSTF RSV RT-PCR SAEs SAg SCF SCIT SD SF-36 sLe(x) SMD SMG SN-5 survey SNOT SNP SP-A SPD SPT SRSA STAT SUNCT TARC TBP TCR TDS TEPD tgAAVCF

Patient Reported Outcome Measures Pattern Recognition Receptor Paranasal sinus pneumatization Quality of Life Regulated upon Activation, Normal T-cell Expressed, and Secreted Radioallergosorbent test Randomised controlled trial Reactive nitrogen species Reactive oxygen species Relative Risk Rhinosinusitis Disability Index Rhinosinusitis Task Force Respiratory syncytial virus Staphylococcal enterotoxins Serious adverse events Staphylococcal superantigenic toxins Stem cell factor Subcutaneous Immunotherapy Standard deviation Short Form (36) Health Survey Sialylated Lewis X Standardised mean difference Submucosal gland Sinus and Nasal Quality of Life Survey Sino-Nasal Outcome Test Single nucleotide polymorphisms Surfactant protein A Surfactant protein D Skin Prick Test Slow reacting substance of anaphylaxis Signal transducer and activator of transcription Short-lasting neuralgiform pain with conjunctival injection and tearing Thymus and activation-regulated chemokine Temporal bone pneumatization T cell receptor Three times daily Sinus transepithelial potential difference Adeno-associated cystic fibrosis transmembrane conductance regulator (CFTR) viral vector/gene construct

TGF TIMP TLR TNF TSLP TXA2 URTI VAS VCAM VEGF

Transforming growth factor Tissue inhibitors of metalloproteinase Toll-like receptor Tumor necrosis factor Thymic stromal lymphopoietin Thromboxane Upper respiratory tract infection Visual analogue scale Vascular cell adhesion protein Vascular endothelial growth factor

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1.

Introduction

Rhinosinusitis is a significant health problem which seems to mirror the increasing frequency of allergic rhinitis and which results in a large financial burden on society (1) . The last decade has seen the development of a number of guidelines, consensus documents and position papers on the epidemiology, diagnosis and treatment of rhinosinusitis and nasal polyposis (1-6). In 2005 the first European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) was published (4, 7). This first evidence based position paper was initiated by the European Academy of Allergology and Clinical Immunology (EAACI) to consider what was known about rhinosinusitis and nasal polyps, to offer evidence based recommendations on diagnosis and treatment, and to consider how we could make progress with research in this area. The paper was endorsed by the European Rhinologic Society. Such was the interest in the topic and the increasing number of publications that by 2007 we felt it necessary to update the document: EP3OS2007 (1, 5). These new publications included some important randomized controlled trials and filled in some of the gaps in our knowledge, which has significantly altered our approach. In particular it has played an important role in the understanding of the management of ARS and has helped to minimize unnecessary use of radiological investigations, overuse of antibiotics, and improve the under utilisation of nasal corticosteroids (8). EP3OS2007 has had a considerable impact all over the world but as expected with time, many people have requested that we revise it, as once again a wealth of new data has become available in the intervening period. Indeed one of its most important roles has been in the identification of the gaps in the evidence and stimulating colleagues to fill these with high quality studies. The methodology for EPOS2012 has been the same as for the other two productions. Leaders in the field were invited to critically appraise the literature and write a report on a subject assigned to them. All contributions were distributed before the meeting in November when the group came together in Amsterdam and during the 4 days of the meeting every report was discussed in detail. In addition general discussions on important dilemmas and controversies took place. Finally the management schemes were revised significantly in the light of any new data which was available. Finally we decided to remove the 3 out of EPOS2012 title (EPOS212 instead of EP3OS2012) to

make it more easy to reproduce. Evidence based medicine is an important method of preparing guidelines. In 1998 the Centre for Evidence Based Medicine (CEBM) published its levels of evidence, which were designed to help clinicians and decision makers to make the most out of the available literature. Recently the levels of evidence were revised in the light of new concepts and data (Table 1). Moreover a number of other systems which grade the quality of evidence and strength of recommendation have been proposed. The most important of these is probably the GRADE initiative (9). For the EPOS2012 we have chosen to collect the evidence using the orginal CEBM format but we plan to update the EPOS2012 clinical recommendations subsequently, following the approach suggested by the GRADE working group.

Table 1.1. Category of evidence (10). Ia Ib IIa IIb III Evidence from meta-analysis of randomised controlled trials Evidence from at least one randomised controlled trial Evidence from at least one controlled study without randomisation Evidence from at least one other type of quasi-experimental study Evidence from non-experimental descriptive studies, such as comparative studies, correlation studies, and case-control studies IV Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both

Table 1.2. Strength of recommendation. A B C D Directly based on category I evidence Directly based on category II evidence or extrapolated recommendation from category I evidence Directly based on category III evidence or extrapolated recommendation from category I or II evidence Directly based on category IV evidence or extrapolated recommendation from category I, II or III evidence

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European Position Paper on Rhinosinusitis and Nasal Polyps 2012.

This EPOS 2012 revision is intended to be a state-of-the art review for the specialist as well as for the general practitioner: to update their knowledge of rhinosinusitis and nasal poly-posis; to provide an evidence based review of the diagnostic methods; to provide an evidence-based review of the available treatments; to propose a stepwise approach to the management of the disease; to propose guidance for definitions and outcome measurements in research in different settings. Overall the document has been made more consistent, some chapters are significantly extended and others are added. Last but not least contributions from many other part of the world have increased our knowledge and understanding. One of the important new data acquired in the last year is that on the prevalence of CRS in Europe. Previously we had relied on estimates from the USA pointing at a prevalence of 14%. Firstly the EPOS epidemiological criteria for CRS from the 2007 document were validated. We have shown that the EPOS symptom-based definition of CRS for epidemiological research has a moderate reliability over time, is stable between study . centres, is not influenced by the presence of allergic rhinitis, and is suitable for the assessment of geographic variation in

prevalence of CRS (11). Secondly, a large epidemiological study was performed within the GA(2)LEN network of excellence in 19 centres in 12 countries, encompassing more than 50.000 respondents, in which the EPOS criteria were applied to estimate variation in the prevalence of Chronic rhinosinusitis for Europe. The overall prevalence of CRS was 10.9% with marked geographical variation (range 6.9-27.1) (12). There was a strong association of asthma with CRS at all ages and this association with asthma was stronger in those reporting both CRS and allergic rhinitis (adjusted OR: 11.85). CRS in the absence of nasal allergies was positively associated with late-onset asthma (13). In the EPOS2012 we have made a stricter division between CRS with (CRSwNP) and without nasal polyps (CRSsNP) (14). Although there is a considerable overlap between these two forms of CRS in inflammatory profile, clinical presentation and effect of treatment (1, 15-20) there are recent papers pointing to differences in the respective inflammatory profiles (21-26) and treatment outcome (27). For that reason management chapters are now divided in ARS, CRSsNP and CRSwNP. In addition the chapters on acute and chronic paediatric rhinosinusitis are totally revised and all the new evidence is implemented. We sincerely hope that EPOS will continue to act as a stimulus for continued high quality clinical management and research in this common but difficult range of inflammatory conditions.

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2.

CLASSIFICATION AND DEFINITION OF RHINOSINUSITIS

2.1. IntroductionRhinitis and sinusitis usually coexist and are concurrent in most individuals; thus, the correct terminology is now rhinosinusitis. Most guidelines and expert panel documents now have adopted the term rhinosinusitis instead of sinusitis (1, 2, 6, 28, 29).. The diagnosis of rhinosinusitis is made by a wide variety of practitioners, including allergologists, otolaryngologists, pulmonologists, primary care physicians, paediatricians, and many others. Therefore, an accurate, efficient, and accessible definition of rhinosinusitis is required. Due to the large differences in technical possibilities to diagnose and treat rhinosinusitis with or withouw nasal polyps by various disciplines, the need to differentiate between subgroups varies. On the one hand the epidemiologist wants a workable definition that does not impose too many restrictions to study larger populations. On the other hand researchers in a clinical setting are in need of a set of clearly defined items that describes their patient population (phenotypes) accurately and avoids the comparison of apples and oranges in studies that relate to diagnosis and treatment. The taskforce tried to accommodate these different needs by offering definitions that can be applied in different circumstances. In this way the taskforce hopes to improve the comparability of studies, thereby enhancing the evidence based diagnosis and treatment of patients with rhinosinusitis and nasal polyps. and/or CT changes: mucosal changes within the ostiomeatal complex and/ or sinuses

2.2.2. Clinical definition of rhinosinusitis in childrenPaediatric rhinosinusitis is defined as: inflammation of the nose and the paranasal sinuses characterised by two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/ posterior nasal drip): facial pain/pressure cough and either endoscopic signs of: nasal polyps, and/or mucopurulent discharge primarily from middle meatus and/or oedema/mucosal obstruction primarily in middle meatus and/or CT changes: mucosal changes within the ostiomeatal complex and/ or sinuses

2.2. Clinical definition of rhinosinusitis2.2.1. Clinical definition of rhinosinusitis in adultsRhinosinusitis in adults is defined as: inflammation of the nose and the paranasal sinuses characterised by two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell and either endoscopic signs of: nasal polyps, and/or mucopurulent discharge primarily from middle meatus and/or oedema/mucosal obstruction primarily in middle meatus

2.2.3. Severity of the disease in adult and children*The disease can be divided into MILD, MODERATE and SEVERE based on total severity visual analogue scale (VAS) score (0 10 cm): MILD = VAS 0-3 MODERATE = VAS >3-7 SEVERE = VAS >7-10 To evaluate the total severity, the patient is asked to indicate on a VAS the answer to the question: A VAS > 5 affects the patient QOL only validated in adult CRS to date How troublesome are your symptoms of rhinosinusitis?10 cm Not troublesome Worst thinkable troublesome

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2.2.4. Duration of the disease in adults and childrenAcute: < 12 weeks complete resolution of symptoms. Chronic: 12 weeks symptoms without complete resolution of symptoms. Chronic rhinosinusitis may also be subject to exacerbations

2.3. Definition for use in epidemiology studies/General PracticeFor epidemiological studies the definition is based on symptomatology without ENT examination or radiology.

2.3.1. Definition of acute rhinosinusitis2.3.1.1. Acute rhinosinusitis (ARS) in adultsAcute rhinosinusitis in adults is defined as: sudden onset of two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure, reduction or loss of smell for 38C) Elevated ESR/CRP Double sickening (i.e. a deterioration after an initial milder phase of illness). (for more details see chapter 3.3.2.1.5)

Figure 2.2 Definition of ARS

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2.3.2.2. Definition of Chronic rhinosinusitis in childrenChronic rhinosinusitis (with or without nasal polyps) in children is defined as: presence of two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure; cough; for 12 weeks; with validation by telephone or interview.

2.4.2. Definition of chronic rhinosinusitis when sinus surgery has been performedOnce surgery has altered the anatomy of the lateral wall, the presence of polyps is defined as bilateral pedunculated lesions as opposed to cobblestoned mucosa > 6 months after surgery on endoscopic examination. Any mucosal disease without overt polyps should be regarded as CRS.

2.4.3. Conditions for sub-analysisThe following conditions should be considered for sub-analysis: 1. aspirin sensitivity based on positive oral, bronchial, or nasal provocation or an obvious history; 2. asthma / bronchial hyper-reactivity / COPD / bronchiectasies based on symptoms, respiratory function tests; 3. allergy based on specific serum specific IgE or Skin Prick Test (SPT). 4. total IgE in serum (treatment effects may be influenced by IgE level)

2.4. Definition for researchFor research purposes acute rhinosinusitis is defined as above. Bacteriology (antral tap, middle meatal culture) and/or radiology (X-ray, CT) are advised, but not obligatory. For research purposes chronic rhinosinusitis (CRS) is defined as per the clinical definition. For the purpose of a study, the differentiation between CRSsNP and CRSwNP must be based on endoscopy.

2.4.1. Definition of chronic rhinosinusitis when no earlier sinus surgery has been performedChronic rhinosinusitis with nasal polyps (CRSwNP): bilateral, endoscopically visualised in middle meatus. Chronic rhinosinusitis without nasal polyps (CRSsNP): no visible polyps in middle meatus, if necessary following decongestant. This definition accepts that there is a spectrum of disease in CRS which includes polypoid change in the sinuses and/ or middle meatus but excludes those with polypoid disease presenting in the nasal cavity to avoid overlap.

2.4.4. Exclusion from general studiesPatients with the following diseases should be excluded from general studies, but may be the subject of a specific study on chronic rhinosinusitis with or without nasal polyps: 1. cystic fibrosis based on positive sweat test or DNA alleles; 2. gross immunodeficiency (congenital or acquired); 3. congenital mucociliary problems (eg. primary ciliary dyskinesia (PCD)); 4. non-invasive fungal balls and invasive fungal disease; 5. systemic vasculitis and granulomatous diseases; 6. cocaine abuse; 7. neoplasia.

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3. Acute Rhinosinusitis3.1. Epidemiology and predisposing factors of ARS SummaryARS is a very common condition that is primarily managed in primary care. Prevalence rates vary from 6-15% depending on the study parameters, although studies specifying ARS report 6-12%, with a prevalence of recurrent ARS estimated at 0.035%. The primary cause of ARS are viruses with 0.5-2.0% of patients developing acute bacterial rhinosinusitis secondary to a viral infection. Prevalence of ARS varies with season (higher in the winter months) and climatic variations, and increasing with a damp environment and air pollution. There appears to be overwhelming bodies of evidence to support the hypotheses that on-going allergic inflammation and cigarette smoke exposure predispose patients to ARS possibly via changes to ciliary motility and function. However, the role of laryngopharyngeal reflux in ARS is unclear. Chronic concomitant disease in children, poor mental health, and anatomical variations have been associated with an increased likelihood of ARS. Although ciliary function is altered in ARS, there is little evidence to support a role for ARS in primary cilia dyskinesia progression. Further research is required to elucidate the underlying mechanisms by which on-going allergy and cigarette smoke exposure increases susceptibility to ARS is urgently needed. This review found that there is a paucity of studies characterising patients with ARS and concomitant diseases. Characterisation studies are required to identify possible co-existing or predisposing diseases beyond allergy, smoking, and possibly laryngopharyngeal reflux. suffer seven to ten colds per year (8, 30). Approximately 0.5-2% of viral upper respiratory tract infections are complicated by bacteria infection (8, 31). In a recent analysis of ENT problems in children using data from Dutch general practices participating in the Netherlands Information Network of General Practice from 2002 to 2008, Uijen et al. (32) reported stable incident rates of 18 cases of sinusitis per 1000 children aged 12-17 years per year and 2 cases per 1000 children in those aged 0-4 years. In children aged 5-11, Uijen et al. observed a decreasing incidence from 7 cases per 1000 children in 2002 down to 4/1000 in 2008 (p39C, purulent rhinorrhoea and facial pain or, more commonly, as a prolonged URTI with chronic cough and nasal discharge. In a study of the relationship between symptoms of acute respiratory infection and objective changes within the sinuses utilizing MRI scans, 60 children (mean age=5.7 yrs.) were investigated who had symptoms for an average of 6 days before scanning (467) . Approximately 60% of the children had abnormalities in their maxillary and ethmoid sinuses, 35% in the sphenoid sinuses, and 18% in the frontal sinuses. In 26 children with major abnormalities, a follow up MRI scan taken 2 weeks later showed a significant reduction in the extent of abnormalities irrespective of resolution of clinical symptoms. This study reinforces the notion that, like in adults, every upper respiratory tract infection is essentially an episode of rhinosinusitis with common involvement of the paranasal sinuses by the viral process.

3.6.2. Paranasal Sinus DevelopmentNot all sinuses are well developed at birth. The frontal sinuses are indistinguishable from the anterior ethmoid cells and they grow slowly after birth so that they are barely seen anatomically at 1 year of age. After the fourth year, the frontal sinuses begin to enlarge and can usually be demonstrated radiographically in around 20-30% of children at age 6 years (465). Their size continues to increase into the late teens and more than 85% of children will show pneumatized frontal sinuses on CT scanning at the age of 12 years (465). When volume estimates are generated from examining 3D reconstructions of CT scans, the volume is around 2 ml around age 10 years and reaches adult size around age 19 with mean volume after full growth being 3.46 ml (466). At birth, the ethmoid and maxillary sinuses are the only sinuses that are large enough to be clinically significant as a cause of rhinosinusitis. In one study, more than 90% of subjects showed radiographically visible ethmoid sinuses at birth (465). The ethmoid sinuses rapidly increase in size until 7 years of age and complete their growth by age 15-16 years with a mean volume after full growth averaging 4.51 ml (466). The maxillary sinuses are usually pneumatized at birth and the volume in patients at 2 years of age is around 2 ml (466). The sinus grows rapidly reaching around 10 ml in volume around age 9 years and full growth volume by 15 years averaging 14.8 ml. Much of the growth that occurs after the twelfth year is in the inferior direction with pneumatisation of the alveolar process after eruption of the secondary dentition. By adulthood, the floor of the maxillary sinus is usually 4-5 mm inferior to the floor of the nasal cavity. At birth, the size of the sphenoid sinus is small and is little more than an evagination of the sphenoethmoidal recess. By the age of 7 years, the sphenoid sinuses have extended posteriorly to the level of the sella turcica and over 85% of patients have pneumatized sphenoid sinuses visualized on CT scanning by age 8 years (465). The sphenoid sinuses exhibit a growth spurt between 6-10 years of age and growth is completed by the age of 15 years with the mean volume after full growth averaging 3.47 ml (466). By the late teens, most of the sphenoid sinuses have aerated to the dorsum sellae and some further enlargement may occur in adults.

Few viral ARS episodes progress to bacterial ARS.Despite the lack of good studies, most clinicians and investigators agree that the diagnosis of bacterial ARS can be made after a viral URTI when children have persistent URI symptoms for >10 days without improvement (nasal discharge, daytime cough worsening at night) or an abrupt increase in severity of symptoms after initial improvement of symptoms of

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a URTI, or a URTI that seems more severe than usual (high fever, copious purulent nasal discharge, periorbital oedema and pain) (8 , 96, 468) . In a longitudinal study of 112 children aged 6-35 months, 623 URTIs were observed over a 3-year period and episodes of sinusitis as defined above were documented by the investigators (31). Eight percent of the URIs were complicated by sinusitis, with 29% of the episodes diagnosed because of an increase in the severity of symptoms before 10 days of illness and the remaining diagnosed on the basis of persistent symptoms beyond 10 days. The occurrence of sinusitis in the context of URIs was 7% in the 6-11 month age group and in children over 24 months, and 10% in children who were 12-23 months old. In an older, but similar, study, 159 full term infants were followed prospectively for a 3 year period and the frequency of URIs and complicating sinusitis were evaluated (469). The authors calculated the percentage of children experiencing symptoms beyond 2 standard deviations from the mean duration of respiratory symptoms (in days) and took that as an indicator of ARS. This value varied with age and ranged between 16 and 22 days. The incidence based on these assumptions ranged between 4 and 7.3% and was highest for children in their first year of life and in day care. On average, a child younger than 5 years of age has 2 to 7 episodes of URTI per year (470, 471), and a child attending day care may have up to 14 episodes per year (472). With the incidence rates reported above, the number of acute sinusitis episodes in children every year is sizeable. Distinguishing between ARS and CRS is based on duration of illness in both children and adults. ARS is defined by symptoms lasting

Chronic Rhinosinusitis 2012

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