Glaxo smithkline philippines clinical practice guidelines ruzanne magiba-caro md edilberto m. Jose md




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UNIVERSITY OF THE PHILIPPINES – PHILIPPINE GENERAL HOSPITAL

DEPARTMENT OF OTORHINOLARYNGOLOGY

with the continuing medical education support of
GLAXO SMITHKLINE PHILIPPINES


CLINICAL PRACTICE GUIDELINES

RUZANNE MAGIBA-CARO MD EDILBERTO M. JOSE MD



Co-chairs
ERASMO GONZALO D.V. LLANES MD JASON S. GUEVARA MD

CHRISTINE JOY S. ARQUIZA MD VINCENT MARK M. JARDIN MD

CHRISTOPHER MALORRE E. CALAQUIAN MD JERIEL JOHN C. MAJAM MD

JOSE ROBERTO V. CLARIDAD MD DANILO R. LEGITA MD

ERICK G. DUCUT MD


CONSENSUS PANEL

GENEROSO T. ABES MD MPH

Department Chair
MARIANO B. CAPARAS MD ROMEO L. VILLARTA, JR. MD MPH

JOSELITO C. JAMIR MD JOSE FLORENCIO F. LAPEÑA, JR. MA MD

EUTRAPIO S. GUEVARA JR MD TERESA LUISA I. GLORIA-CRUZ MD MHPEd

ALFREDO Q.Y. PONTEJOS JR MD RAMON ANTONIO B. LOPA MD

JAIME F. FLOR MD ROBERTO M. PANGAN DMD MD PhD

JOSEFINO G. HERNANDEZ MD MARIA RINA T. REYES-QUINTOS MD MCAud

RENE S. TUAZON MD MELFRED L. HERNANDEZ MD MHA

JACOB S. MATUBIS MD NATHANIEL W. YANG MD

CESAR V. VILLAFUERTE JR MD MHA ARMANDO M. CHIONG, JR. MD

CHARLOTTE M. CHIONG MD AGNES N. TIRONA-REMULLA MD

ABNER L. CHAN MD JEANNETTE MARIE S. MATSUO MD

FELIX P. NOLASCO MD




RESIDENTS

LINA ROSE A. ALCANCES MD MOH MICHAEL F. GALICIA MD

ERWIN M. ESLAVA MD DESIREE B. VANGUARDIA MD

HERBERT Q. GUTIERREZ MD CAMILLE SIDONIE A. ESPINA MD

ERIC T. VINCULADO MD MARY APPLE PIE M. GARCIA MD

MARIO ADRIAN M. ZAFRA MD FELICIDAD B. MENDOZA MD

FORTUNA CORAZON A. ABERIN MD LEI-JOAN V. MOLO MD

ARSENIO CLARO A. CABUNGCAL MD IVY D. PATDU MD

RYNER JOSE C. CARRILLO MD FLORENCE YUL N. SAQUIAN MD

PHILIP B. FULLANTE MD JOSEPH ROY VINCENT B. UMALI MD



UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES
PURPOSE OF THE CLINICAL PRACTICE GUIDELINES

The UP-PGH Department of Otorhinolaryngology handles about 45,000 patients a year. It must ermbrace the influx of new concepts, current techniques, diagnostic and therapeutic options. At the same time, it has to struggle to keep a balance between this and the availability of its limited resources. The development of clinical practice guidelines in selected areas is designed to help fill in the gap to maximize patient care in the department.


TARGET POPULATION, SETTING AND PROVIDERS OF CARE

Charity patients seen by the consultant and resident staff of the UP-PGH Department of Otorhinolaryngology are the target population. The conditions include: (1) chronic suppurative otitis media in adults; (2) nasal polyps in adults; (3) acute and chronic tonsillitis in children and adults; (4) obstructive sleep apnea in children; (5) thyroid masses in adults; (6) cleft lip and palate in children and adolescents; and (7) tracheostomy and decannulation in children and adults.



METHODS OF GUIDELINE DEVELOPMENT


The UP-PGH Department of Otorhinolaryngology has six subspecialty study groups to which consultants and residents are assigned. Each of the study groups chose one common clinical condition, which they felt needed a protocol for effective and efficient management. They conducted the literature search and developed evidence-based recommendations (EBR). In the case of the Cranio-Maxillofacial, Plastic and Reconstructive Surgery study group, they met with the rest of the CLAP team in the development of the EBR. The consultant and resident staff convened in Caliraya, Laguna on September 2-3, 2003, to deliberate on the EBRs, modify, arrive at a consensus and ratify the CPG.

PANEL RECOMMENDATIONS AND LEVELS OF EVIDENCE


All literature were classified according to levels of evidence and grades of recommendations based on guidelines from the US Agency for Health Care Policy and Research and are set out as follows:

STATEMENTS OF EVIDENCE

GRADES OF RECOMMENDATION


Ia

Obtained from meta-analysis of randomized controlled trials

A


Requires at least one randomized controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation

Ib

Obtained from at least one randomized controlled trial

IIa

Obtained from at least one well-designed controlled study without randomization

B


Requires the availability of well conducted clinical trials but no randomized clinical trials on the topic of recommendation

IIb

Obtained from at least one other type of well-designed quasi-experimental study

III

Obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies

IV

Obtained from expert committee reports or opinions and/or clinical experience of respected authorities

C


Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality


UP-PGH DEPARTMENT OF OTORHINOLARYNGOLOGY CLINICAL PRACTICE GUIDELINES

CHRONIC SUPPURATIVE OTITIS MEDIA IN ADULTS
SCOPE OF THE PRACTICE GUIDELINE

This clinical practice guideline is for use by the Department of Otorhinolaryngology of the College of Medicine - Philippine General Hospital, University of the Philippines Manila. It covers the diagnosis and management of chronic suppurative otitis media in adults (19 years old and above).


OBJECTIVES

The objectives of the guideline are (1) to emphasize the requisites of diagnosis of chronic suppurative otitis media in adults; (2) to evaluate current diagnostic techniques; and (3) to describe treatment options.


LITERATURE SEARCH

This guideline is based on the 1997 Clinical Practice Guidelines of the Philippine Society of Otolaryngology– Head and Neck Surgery and revised according to new evidence. The National Library of Medicine’s PubMed database and Cochrane Reviews database were searched for literature using the keyword otitis media, suppurative. The search was limited to articles involving humans and those published in English in the last fifteen years, WHO reports, and the PGH Annual Report. It yielded 549 articles. Thirty-eight (38) abstracts were chosen and results were further assessed for relevance. Full text articles were obtained when possible. The chosen articles were divided as follows:


Meta-analysis 2

Randomized controlled trial 2

Non-randomized controlled study 3

Descriptive study 1

Committee report 1
DEFINITION

Chronic suppurative otitis media (CSOM) is a persistent inflammation of the middle ear or mastoid cavity. Synonyms include “chronic otitis media (without effusion)”, “chronic mastoiditis” and “chronic tympanomastoiditis”. Chronic suppurative otitis media is characterized by persistent or recurrent ear discharge (otorrhea) over 3 months through a perforation of the tympanic membrane.9 Typical findings may include thickened granular middle ear mucosa, mucosal polyps and cholesteatoma within the middle ear. Chronic suppurative otitis media does not include chronic perforations of the eardrum that are dry, discharge only occasionally, and have no signs of active infection.2
PREVALENCE

Worldwide prevalence of chronic suppurative otitis media is 65-330 million people. Between 39 to 200 million (60%) suffer from significant hearing impairment. Otitis media has been estimated to cost 28,000 deaths and a loss of over 2 million in Disability Adjusted Life Years (DALY) in 2000, 94% of which are in developing countries. Most of these deaths are presumably due to chronic suppurative otitis media, because acute otitis media is a self-limiting infection2.



In the Philippines, the prevalence of CSOM is estimated at 2.5% to 29.5% based on several surveys among children in Metro Manila and Mindanao.9 It has been reported that CSOM patients constitute 14% of outpatient consults at the University of Santo Tomas Hospital 4, and 30% of emergency cases and 60% of operated ears at the PGH 9. The number of referrals (pediatric and adult patients) with diagnosis of CSOM in the ORL-Outpatient Ear Specialty Clinic of the Philippine General Hospital numbers to 325 in 2002.
RECOMMENDATIONS ON THE DIAGNOSIS OF CHRONIC SUPPURATIVE OTITIS MEDIA
The assessment begins with a thorough history of the frequency, duration, and characteristics of the discharge. Physical examination of the affected ear requires cleansing of the external auditory canal before the tympanic membrane can be accurately assessed. The eardrum must be adequately visualized for accurate diagnosis and treatment.6

1. CSOM is diagnosed by the presence of a tympanic membrane perforation and a history of persistent or recurrent ear discharge for more than 3 months.

Grade C Recommendation
The presence of tympanic membrane perforation and persistent or recurrent otorrhea for more than 3 months is still considered by the panel to be diagnostic of CSOM. (Task Force of the Fourth International Symposium of Otitis Media Florida, June 1987).4 Critical to this definition is the history of chronic active otorrhea for more than 3 months. The histopathologic definition of CSOM was not used.
2. Pure tone audiometry and speech testing (PTA-ST) must be performed as part of the total diagnostic assessment.

Grade C Recommendation
The panel recognized the value of the PTA-ST in the initial evaluation of patients with CSOM because it provides information on the etiology of hearing loss (conductive, mixed and sensorineural) in the ipsilateral and contralateral ear. Moreover, it gives baseline data on the pre-operative hearing status of a patient, which is important in surgical planning and in evaluating the effectiveness of tympanoplasty and ossiculoplasty.
3. Radiographic imaging studies, in the form of mastoid radiograph or computed tomography scanning, are considered ancillary diagnostic tools.

Grade B Recommendation
Mastoid radiographs are used to evaluate the degree of pneumatization particularly in surgical ears. Previous studies showed high false negative rates and low sensitivity (54%)9 when mastoid radiographs were correlated with intra-operative findings of cholesteatoma. There is also a marked paucity of studies on the use of mastoid radiographs in our review of literature.
High-resolution computed tomography (HRCT) of the temporal bone is not routinely requested but may have a value in (1) children, (2) medically unfit patients, (3) only or better hearing ear, (4) patients in whom the tympanic membrane cannot be adequately visualized, (5) patients who have had previous mastoid surgery, and (6) patients with intra-temporal or intracranial complications. 4, 5, 6 ,7
4. Culture and sensitivity of ear discharge is not part of the routine initial diagnostic assessment.

Grade A Recommendation
In the prospective comparative study of Khanna et al3 of 110 patients with active CSOM, the group with culture and sensitivity prior to antibiotic treatment (broad-spectrum antibiotic drops) attained dry ears in 100%, while the group without culture and sensitivity had a cure rate of 74%. Based on these findings, they concluded that there is no definite role of culture and sensitivity in the initial management of all cases of CSOM. This is further supported by local studies that show no significant change in the pathogenic organisms in patients with CSOM within the last twenty years. Therefore, patients with CSOM should initially be prescribed a broad-spectrum antibiotic. Only in cases with failure of initial therapy should culture and sensitivity be done.

RECOMMENDATIONS ON THE TREATMENT OF CHRONIC SUPPURATIVE OTITIS MEDIA
1. Aural toilet is an essential part of the treatment of CSOM in all patients.

Grade A Recommendation
Ear cleansing, also known as aural toilet, consists of mechanically removing ear discharge and other debris from the ear canal and middle ear by mopping with cotton pledgets, wicking with gauze, flushing with sterile solution, or suctioning. This can be done with an oto-microscope, or under direct vision with adequate illumination of the middle ear.2
The meta-analysis by Acuin et al2 showed that aural toilet, especially when combined with antibiotic treatment is more effective in drying up otorrhea and eradicating middle ear bacteria than no treatment. There was no good evidence of benefit from simple ear cleansing. Thus, the panel agreed that aural toilet should be part of the initial management of CSOM in order (1) to clean the ear canal and middle ear cavity; (2) adequately visualize and assess the middle ear; (3) to allow the topical antibiotic to reach the middle ear cavity; and (4) to provide symptomatic relief for the patient.
2. Topical quinolones, specifically ofloxacin, are recommended for the initial management of CSOM for a period of 10-14 days. For persistent otorrhea, antibiotic therapy for an additional two weeks is recommended.

Grade A Recommendation
Treatment of CSOM with aural toilet and topical antibiotics, particularly quinolones, is effective in resolving otorrhea and eradicating bacteria from the middle ear. Acuin et al2, in a systematic review of five trials, reported that topical quinolones are more effective than non-quinolones. Abes et al1, concluded in their meta-analysis that 0.3% ofloxacin otic solution is better than other antibiotic otic drops and oral antibiotics in terms of overall cure rate and resolution of secondary outcome parameters. Thus, the topical ofloxacin given for 10-14 days is highly recommended.
If there is insufficient symptomatic improvement or treatment failure, topical quinolones can be applied for two more weeks, increasing clinical efficacy without causing safety problems.7
3. Systemic antibiotics may be given for CSOM with associated bacterial upper repiratory infections and complications.

Grade C Recommendation
One systematic review found that systemic antibiotics were significantly less effective than topical antibiotics in reducing otoscopic features of chronic suppurative otitis media.Thus, topical antibiotics remain to be the mainstay of treatment in CSOM. However, systemic anitibotics may still be given to CSOM patients with associated bacterial upper respiratory tract infections and complications.
4. Surgery must be performed on all cases of CSOM with suppurative complications.

Grade C Recommendation
Panel members agreed that the presence of intracranial and extracranial complications in patients with CSOM is an absolute indication for mastoidectomy based on pathophysiologic understanding of the disease and numerous case series.2 These complications include brain abscess, meningitis, otitic hydrocephalus, lateral sinus thrombophlebitis, facial nerve paralysis, labyrinthitis, and subperiosteal abscesses.
5. Surgery may be performed for those who fail to respond to adequate medical treatment.

Grade C Recommendation
There are no randomized clinical trials to date comparing medical treatment and mastoidectomy in those patients in whom either procedure is a valid alternative. However, case series describing the intra-operative findings of medically intractable cases have been published.9 The indications for abandoning medical therapy are currently unclear; thus, the panel saw no justification in making definite recommendations for the performance of either procedure.

REFERENCES
1. Abes G, Espallardo N, Tong M, Subramaniam KN, Hermani B, Lasiminigrum L, Anggraeni R. “A Systematic Review Of The Effectiveness of Ofloxacin Otic Solution For The Treatment Of Suppurative Otitis Media.” J ORL & Health Specialties; Mar-Apr 2003.
2. Acuin J, Smith A, Mackenzie I. “Interventions For Chronic Suppurative Otitis Media.” Cochrane Database Syst Rev. 2000; (2): CD000473.
3. Khanna, V., Chander J. Nagarkar NM, Dass A. “ Clinicomicrobiologic evaluation of active tubotympanic type of chronic suppurative otitis media.”

J. Otolaryngol. 2000 June; 29(3):148-53.


4. Leighton SE, Robson AK, Anslov P., Melford CA, “The Role of CT Imaging in the Management of CSOM. Clin. Otolaryngol. 1993 Feb; 18(1):23-9.
5. O ‘Reilly BJ, et al. “The Value of CT Scanning in Chronic Suppurative Otitis Media.” J. Laryngol. Otol. 1991 Dec; 105(12):990-4.
6. Ramsey AM. “Diagnosis and Treatment of the Child with a Draining Ear” J. Pediatr. Health Care. 2002 Jul-Aug; 16(4) :161-9. (abstract)
7. Suzuki K, Nishimura T, Baba S, Yanagita N, Ishigami H. “Topical Ofloxacin For Chronic Suppurative Otitis Media And Acute Exacerbation Of Chronic Otitis Media: Optimum Duration Of Treatment.” Otol Neurotol. 2003 May; 24(3): 447-52.
8. 2002 Annual Report, Out-patient Department, Philippine General Hospital.
9. Clinical Practice Guidelines 1997, PSO-HNS.


OTOSCOPY

and other relevant ORL exams



Aural Toilet


Y





N

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