Assessment of Tympanic Membrane A study of children with otitis media in general practice. Thorbjörn Lundberg - PDF

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Assessment of Tympanic Membrane A study of children with otitis media in general practice Thorbjörn Lundberg Department of Public Health and Clinical Medicine Umeå 2014 Responsible publisher under swedish

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Assessment of Tympanic Membrane A study of children with otitis media in general practice Thorbjörn Lundberg Department of Public Health and Clinical Medicine Umeå 2014 Responsible publisher under swedish law: the Dean of the Medical Faculty This work is protected by the Swedish Copyright Legislation (Act 1960:729) ISBN: ISSN: New series nr: 1635 Cover by the author Elektronisk version tillgänglig på Tryck/Printed by: Print och Media Umeå, Sweden 2014 To my wife Pernilla, children Adam and Amanda and my mother Svea Abstract Original Papers Abbreviations Sammanfattning på svenska Prologue Introduction 1 Otitis media a common disease 1 What is otitis media? 1 Basic anatomy 3 Methods for diagnosing otitis media 5 How to assess tympanic membrane appearance and middle ear status 6 Characteristics of acute otitis media 9 Bacteriology 13 Treatment of acute otitis media 14 Complications and sequel 15 TM documentation and examination in telemedicine 16 Validity and reliability - a short introduction 17 Aims 19 Methods 20 The Lapland study (papers I, II and IV) 21 The South African study (paper III) 24 Quality of video-endoscopic images (paper I) 26 Development of a new grading scale for AOM (paper II) 28 Test of the OMGRADE scale in a clinical and telemedical setting (paper III) 29 TM appearance and the relation to the course of signs and symptoms (paper IV) 30 Results 32 Characteristics of study populations 32 Quality of TM imaging (papers I, III) 34 Telemedicine technique in children with ear related problems (papers I-IV) 35 Agreement between examiners (papers I-III) 35 Development and test of a new image-based grading scale (papers II, III) 36 TM appearance and the relation to the course of signs and symptoms (paper IV) 39 Discussion 41 Main findings 41 Methodological considerations 41 General discussion 44 Clinical implications 48 Future research 49 Conclusions 50 Acknowledgements 51 References 53 Appendices 59 Appendix A 60 Appendix B 61 II III IV V VIII I Abstract Background Acute otitis media (AOM) is a common disease in children and is causing great discomfort and disability worldwide but many areas are underserved regarding skilled professional. Tele-otology offers a promising technique to provide ear health globally. Diagnostic accuracy of AOM has regardless of method been found to be low. Grading the severity of AOM my offer a guide in decision on antibiotic treatment, however grading systems need improvement. Aim To describe and evaluate imaging of the tympanic membrane (TM), develop an image based grading scale for AOM and to study the characteristics and the course of acute otitis media (AOM) episodes in children with the use of telemedicine techniques. Method This thesis is based on two study populations, 63 children attending with othalgia at four primary health care centers in rural Sweden (papers I, II, IV) and 140 children attending a health clinic from a township in Johannesburg, South Africa, (paper III). Paper I: Image quality of endoscopic imaging of TM s, from the Swedish study was assessed by an otologist and two general practitioners together with an evaluation of important characteristics of assessing TM appearance. Paper II: In development and validation of an image-based grading scale of AOM two expert panels of otologist s evaluated the proposed grading scale stepwise and in a test and retest validation process. Paper III: A test of the scale in a clinical situation was set up, an otologist otomicroscopically examined children and used the grading scale, and his diagnoses were set as gold standard. A specially trained ear and hearing facilitator then recorded videos of the TM using video-otoscopy. Videos were remotely assessed by the same otologist and by a general practitioner twice; 4 and 8 weeks after the otologist s on-site grading. Paper IV: Children with othalgia were followed with assessments of their symptoms and signs over a period of 3 months. An assessment group of two general practitioners and one otologist evaluated TM images, tympanograms and recorded symptoms and make a diagnose. Results The results from paper I show that image quality was good and the position and transparency of the TM was found to be the most important characteristics when assessing TM. In paper II the new grading scale (OMGRADE) was developed and validated. The image-based scale focuses on the position and transparency of the TM. The results from paper III showed that the OMGRADE scale could discriminate the normal ear as well as ears with otitis media with effusion (OME) in an unselected pediatric population. Paper IV showed that the bilateral AOM had more severe symptoms. The children with chagrinated TM s took the longest time to resolve regarding TM appearance and tympanograms. Furthermore, symptoms resolved quicker than TM changes and tympanograms during the first week. Conclusions TM images or video recordings taken by a trained nurse or facilitator are sufficient for remote evaluation. The new grading scale of TM appearance is valid and reliable and may function as a diagnostic guide together with evaluation of middle ear effusion. TM appearance may be of importance in grading the severity of an AOM episode. II Original Papers This thesis is based on the following papers: I) Lundberg T, Westman G, Hellström S, Sandström H. Digital imaging and telemedicine as a tool for studying inflammatory conditions in the middle ear. Evaluation of image quality and agreement between examiners. Int J Pediatr Otorhinolaryngol. 2008; 72(1): II) Lundberg T, Hellström S, Sandström H. Development and validation of a new grading scale for otitis media. Pediatr Infect Dis J. 2013;32(4): III) Lundberg T, Biagio L, Laurent C, Sandström H, Swanepoel DW. A new otitis media scale applied for remote evaluation of video-otoscopy recordings in an unselected pediatric population. [Submitted] IV) Lundberg T, Laurent C, Hellström S, Sandström H. What does othalgia in children represent? A study of acute otitis media in general practice related to symptoms and tympanic membrane status over time. [Manuscript] All papers are reprinted with permission of the copyright holders III Abbreviations AAP American Academy of Paediatrics AOM Acute Otitis Media AOM-FS Acute Otitis Media Faces Scale AOM-SOS Acute Otitis Media Severity Of Symptoms scale baom AOM with bullous myringitis BM Bullous Myringitis CO Clinical Otological score CSOM Chronic suppurative otitis media ENT Specialist in Ear, Nose and Throat disease GP General Practitioner HCC Health Care Centre MEC Middle Ear Cavity NPD Not Possible to Determine OM Otitis Media OME Otitis Media with Effusion ORL Oto-rhino-laryngologist OS-8 Otitis media Scale 8 paom AOM with chagrinated TM or evidence of acute perforation and drainage raom recurrent Acute Otitis Media TM Tympanic Membrane URI Upper Respiratory tract Infection WHO World Health Organization IV Sammanfattning på svenska Bedömning av trumhinnans utseende - en studie på barn med öroninflammation i primärvård Akut öroninflammation är den näst vanligaste infektionen hos barn och har varit den vanligaste orsaken till antibiotikabehandling hos barn i Sverige. I utvecklingsländer är öroninflammation vanligare än i Sverige och ofta av allvarligare slag, dessutom råder i dessa länder en stor brist på kvalificerad vårdpersonal. Telemedicinsk teknik kan erbjuda patienter bedömningar på distans av läkare. Hög förskrivning av antibiotika bedöms bidra till en ökad resistensutveckling hos bakterier vilket i sin tur riskerar att försämra behandlingsresultatet vid allvarligare infektioner. Man försöker därför på olika sätt att minska antibiotikaförbrukningen. En förbättrad diagnostisk säkerhet av öroninflammation hos barn antas kunna minska antibiotikaförskrivningen till dessa barn och en förbättrad kvalitet på trumhinnebedömningar är en förutsättning för detta. Öroninflammationens svårighetsgrad har tidigare studerats och diskuterats ur behandlingssynpunkt och i samband med detta har olika former av graderingssystem, av varierande kvalitet använts. Mål Att utvärdera kvaliteten på bilddokumentation av barns trumhinnor utförd av assistent eller sköterska och att utveckla ett bildbaserat graderingsverktyg för trumhinnebedömningar samt att testa detta på barn. En annan målsättning var att följa symtom och studera trumhinneutseende hos barn i åldern 2-16 år som sökte på hälsocentral för öronvärk och att följa deras tillstånds utveckling över tid. Metod Denna avhandling är baserad på 2 olika studiepopulationer. Lapplandsstudien(delarbete I, II, IV): På 4 olika hälsocentraler i södra Lappland undersöktes 63 barn som sökte för öronsmärta med bilddokumentation av trumhinnan, tympanometri samt registrering av symtom som feber, öronsmärta och påverkat allmäntillstånd En sjuksköterska eller undersköterska ansvarade för studien vid varje hälsocentral och erhöll träning i endoskopisk öronundersökning, tympanometri samt handhavande av den telemedicinska utrustningen. Data lagrades i en central databas med uppkoppling via ett säkert intranät. Sydafrikastudien (delarbete III): På en hälsoklinik för en fattig befolkning i en kåkstad i Johannesburg erbjöds alla barn som besökte kliniken under två veckor (oavsett sökorsak) först en öronmikroskopisk undersökning av en öronläkare och sen en video- otoskopisk filmdokumentation av trumhinnan. Den video- otoskopiska filmningen av trumhinnan gjordes av en assistent utan formell hälsovårdsutbildning. Hon tränades och utförde sen video- otoskopierna som skickades över internet för bedömning i Umeå av samma öronläkare som sett barnen i Sydafrika samt av en svensk distriktsläkare. Resultat Delarbete I: Bildkvaliteten av stillbilder tagna via ett rakt endoskop från Lapplandsstudien undersöktes och bedömdes vara av acceptabel eller mycket god kvalitet i 82% av bildmaterialet. Bildkvaliteten förbättrades under studietiden och var bättre hos de äldre barnen. V Delarbete II: viktiga karakteristika för trumhinnebedömning vid öroninflammation identifierades. 124 trumhinnebilder sorterades i svårighetsgrad, från normalt trumhinneutseende till kraftigt påverkat och en bildbaserad skala framtogs. Expertgrupp A (3 öronläkare) granskade utvalda karakteristika samt skalförslag enligt en metod för att erhålla content validity, innehållsvaliditet. Ett slutgiltigt skalförslag presenterades bestående av 6 grundsteg: 0=transparent, normalställd trumhinna; 1=transparent trumhinna i normal position med klar vätskenivå eller lätt indragen trumhinna; 2=transparent, indragen trumhinna med klar vätskenivå eller med grumlig vätskenivå; 3=hela trumhinnan opak men i väsentligen normal position; 4=opak och buktande trumhinna; 5=opak trumhinna med blåsbildningar eller med en chagrinerad och fuktig yta, alternativt en misstänkt perforation med dränerande pus. Studiegruppen korrigerade skalan efter upprepade genomgångar som utmynnade i ett slutgiltigt skalförslag (OMGRADE). Expertgrupp B (4 öronläkare) testade skalan på trumhinnebilder vid två separata tillfällen och god till mycket god överensstämmelse påvisades. OMGRADE- skalan korrigerades slutligen en sista gång. Delarbete III: Öronläkaren graderade öronen vid öronmikroskopiundersökningen. 180 videofilmer bedömdes på distans efter 1 och 2 månader med nämnda graderingsskala. Den nya graderingsskalan visade på god överensstämmelse mellan öronläkarens öronmikroskopiska bedömning och distansundersökningarna av video- filmerna. Sensitivitet och specificitet av skalans förmåga att detektera normalt öra eller vätskefyllt mellanöra (OME) beräknades mellan öronläkarens bedömningar till 65-70%, respektive %. Delarbete IV: 63 barn med anamnes på öronvärk undersöktes. Nitton procent hade normala öron, 33 % vätskefyllt mellanöra (OME) och 48% akut öroninflammation av något slag. Trumhinnan bedömdes som buktande i 18%, med blåsbildningar i 11% och med chagrinerat utseende i 19%. En uppföljning genomfördes av 29 av dessa barn vid sammanlagt 3 tillfällen - efter 3 och 7 dagar samt efter 3 månader. Symtomen visade sig gå tillbaka snabbare än trumhinneförändringarna och tecken på eventuell vätska i mellanörat. Majoriteten av barnen var helt symtomfria redan dag 3. Barn med chagrinerad trumhinna hade längre tid till utläkning och efter 3 månader hade de fortfarande i 40 % ett avvikande tympanogram. Sammanfattning av resultat Bild eller video- dokumentation av trumhinnans utseende utfört av en assistent, eller sjuksköterska visade på acceptabel till god kvalitet. Video- otoskopiskt filmupptag förefaller kunna erbjuda bättre underlag för bedömning än öronmikroskopi. Den nyutvecklade, validerade graderingsskalan för trumhinnans utseende vid akut öroninflammation, OMGRADE, visade sig korrelera väl med diagnoser satta vid öronmikroskopi av öronläkare samt kunde med god precision detektera såväl normala trumhinnor som vätskefyllt mellanöra (OME). OMGRADE var också användbar i kombination med tympanometri för diagnostik av olika typer av öroninflammation. Den chagrinerade trumhinnan visade sig ta längre tid för utläkning jämfört med den buktande eller bullösa trumhinnan. Symtomen normaliserades snabbare än trumhinneförändringarna. Öronsmärta, såväl måttlig som uttalad, förekom även hos barn med helt normalt öronstatus. VI VII Prologue Directly after medical school I started to work in general practice and had to assess tympanic membranes in children with otalgia. I had never seen a child with otitis media during my medical education, and I believed it to be a simple diagnosis to handle. The surprise was apparent when I examined the first child with earache. Somewhere in the darkness of the external ear canal something that could be the tympanic membrane was seen, was it red? Asking senior colleagues confirmed me that it was red, and yes, an acute otitis media (AOM). After a number of tympanic membranes had passed my otoscope and a number of colleagues had been consulted I started to realise that there was a discrepancy between the different colleagues assessments of the tympanic membranes. They all based their diagnosis on various important tympanic membrane characteristics. During a research course for general practitioners (GP) I was introduced to professor Sten Hellström, specialist in otorhinolaryngology (ORL) and professor Göran Westman, specialist in family medicine (GP), who had outlined a draft for a study on AOM using telemedical equipment in rural areas of Lapland, north of Sweden. Together with my main tutor associate professor Herbert Sandström (GP) we started the planning and preparing of a study to follow the course of signs and symptoms in children with earache. A pilot study on six children at the Tegs health care centre was performed to evaluate the equipment and method. Thereafter, I took the first steps on my scientific journey. I was going to plan, start and control a clinical study that began in 2003 at four health care centres 150 to 200 km away from my hometown Umeå. Now it is time to present where these first scientific steps led me and to describe my journey. It is my hope that this thesis can shed some light on the tympanic membrane and help us general practitioners in the interpretation of the changes of the tympanic membrane appearance. Before going out on a hunt, hunters discuss all the information at their disposal and work out a strategy that will maximise their chances of success. With a detailed knowledge of the country, they will be able to identify areas regularly visited by animals, such as waterholes, pans, dense thickets and the animal paths that connect them. Their knowledge of the habits of animals will also enable them to predict what their movement may be and at what times they may visit certain areas. They will discuss hunts of the recent and distant past, and apply the knowledge they have gained from them. Each hunt is therefore a continuation of previous hunts, taking advantage of experience gained over many years. Principles of tracking Louis Liebenberg VIII IX Aims Introduction Otitis media a common disease Otitis media is the second most common disease in childhood as well as the most common reason for antibiotic treatment in children. The majority of acute otitis media (AOM) episodes occur under the age of 3 years [1]. Up to 70% of children under age 2 are expected to have at least one AOM episode and 20% of the children will have at least three AOM episodes before the age of 5 years. However, the burden of disease around the world differs greatly [2]. AOM is more common in developing countries. In sub-saharan Africa the incidence rate (new episodes per 100 people per year) of AOM of all age groups is estimated to be 43% compared to 11% in central Europe. The incidence in the sub-saharan children aged 1-4 year is greater and every child in these areas will have AOM at least once every year. When it comes to the chronic suppurative otitis media (CSOM) the difference between developing and developed countries is also large. Globally, the incidence is 5 per 1000 people; in Oceania and sub- Saharan Africa 7 9 per 1000 people. In the first year of life the highest incidence rate is found in Oceania (33%). Children in developing countries with otitis media suffer from more complications and even deaths [2]. In a study by Liese et al. [3] the incidence rate in Sweden was found to be 344 per 1000 person-years (34.4%) in the age group 0-2 years and 174 in 3 5 year olds (17.4%). Neumark et al. [4] found a decline by 50% of visits for AOM in the age group 2-16 years between 2000 and The highest risk of developing AOM is in the age from 0.5 to 2 years, and if the child develops AOM during the first 6 months of life the risk is higher for recurrent AOM. What about the effects in daily living for children with otitis media? Among other causes, otitis media is one important reason for hearing impairment around the world. Monasta et al. [2] report prevalence to be that 6 of 1000 children by the age of five in south Asia suffer from hearing impairment related to otitis media. In Western Europe the figure is only 0.1 per Mortality related to AOM is estimated to be approximately 21 per 10 million children worldwide, by WHO estimated to be deaths annually due to complications of otitis media. In wealthy areas in North America it is estimated at 1.6 per 10 million compared to the highest mortality in the Oceania region with 101 per 10 million [2]. What is otitis media? Otitis media (OM) is divided into three major diagnoses: acute otitis media (AOM), otitis media with effusion (OME, in Scandinavia more often described as secretory otitis media SOM) and chronic suppurative otitis media (CSOM). Acute otitis media (AOM) AOM is defined as a fluid-filled middle ear cavity (MEC) together with acute inflammatory signs and symptoms. Bacterial colonisation of the middle ear fluid is often found but sometimes viruses occur. The majority of AOM is secondary to a upper respiratory tract 1 Introduction infection (URI). In a study by Kalu et al. [5] a mean of 5 days with URI preceded the AOM. A bulging TM has high diagnostic certainty. The American Academy of Paediatrics (AAP) states that the diagnosis of AOM can be made in presence of a bulging TM or with acute onset of otorrhea. The diagnosis may also be set if there is a mild bulging of the TM together with recent onset of ear pain or intense erythema of the TM [6]. The appearance of the TM is usually described as a thickened and opaque TM with a more irregular structure and with a white-grey-yellowish discoloration. Increased vascularisation is mainly found along the malleus and annulus fibrosus but has lower diagnostic value than the previously mentioned signs. Symptoms such as otalgia, i
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