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Ngc_8813_1.doc

Complete Summary
GUIDELINE TITLE
BIBLIOGRAPHIC SOURCE(S)
Finnish Medical Society Duodecim. Sore throat and tonsillitis. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2005 Dec 28 [Various]. [3 references] GUIDELINE STATUS
This is the current release of the guideline. This guideline updates a previous version: Finnish Medical Society Duodecim. Sore throat and tonsillitis. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2004 May 13 [Various]. ** REGULATORY ALERT **
FDA WARNING/REGULATORY ALERT
Note from the National Guideline Clearinghouse: This guideline references a
drug(s) for which important revised regulatory information has been released.
On April 7, 2005, the U.S. Food and Drug Administration (FDA) asked manufacturers of non-prescription (over the counter [OTC]) non-steroidal anti-inflammatory drugs (NSAIDs) to revise their labeling to include more specific information about potential gastrointestinal (GI) and cardiovascular (CV) risks, and information to assist consumers in the safe use of the drugs. See the Web site for more information. Subsequently, on June 15, 2005, the FDA requested that sponsors of all NSAIDs make labeling changes to their products. FDA recommended proposed labeling for both the prescription and OTC NSAIDs and a medication guide for the entire class of prescription products. See the for more information. COMPLETE SUMMARY CONTENT
** REGULATORY ALERT ** SCOPE METHODOLOGY - including Rating Scheme and Cost Analysis RECOMMENDATIONS EVIDENCE SUPPORTING THE RECOMMENDATIONS BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS IMPLEMENTATION OF THE GUIDELINE INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES IDENTIFYING INFORMATION AND AVAILABILITY DISCLAIMER DISEASE/CONDITION(S)
GUIDELINE CATEGORY
CLINICAL SPECIALTY
Family Practice Internal Medicine Otolaryngology Pediatrics Surgery INTENDED USERS
GUIDELINE OBJECTIVE(S)
Evidence-Based Medicine Guidelines collect, summarize, and update the core clinical knowledge essential in general practice. The guidelines also describe the scientific evidence underlying the given treatment recommendations. TARGET POPULATION
Children and adults with sore throat and tonsillitis INTERVENTIONS AND PRACTICES CONSIDERED
Diagnosis/Evaluation
1. Clinical assessment, including physical examination of the pharynx, neck palpation, and checking for presence of rash or other focuses of infection 2. Streptococcal culture or rapid test (throat swab culture) for streptococci 3. Rapid test for mononucleosis Treatment/Secondary Prevention
• Penicillin V; cephalexin or cefadroxil in case of penicillin allergy • Cephalexin or cefadroxil as first line therapy in recurrent infection; 2. Analgesics, such as paracetamol, ibuprofen, or lidocaine spray 3. Antibiotics for pharyngeal gonorrhea 4. Drainage and antibiotics for peritonsillar abscess 5. Tonsillectomy Recognition and Control of Epidemics
1. Streptococcal culture from symptomatic and asymptomatic people 2. Simultaneously treatment of persons with positive cultures 3. Consider cultures from and treatment of family members of symptomatic MAJOR OUTCOMES CONSIDERED
• Incidence of rheumatic fever, glomerulonephritis, otitis media, and sinusitis • Overall, bacteriological, and clinical cure rates • Incidence of recurrent throat infection following tonsillectomy METHODOLOGY
METHODS USED TO COLLECT/SELECT EVIDENCE
Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE
The evidence reviewed was collected from the Cochrane database of systematic reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). In addition, the Cochrane Library and medical journals were searched specifically for original publications. NUMBER OF SOURCE DOCUMENTS
METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE
EVIDENCE

Weighting According to a Rating Scheme (Scheme Given) RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE
Levels of Evidence
A. Strong research-based evidence. Several relevant, high-quality scientific B. Moderate research-based evidence. At least one relevant, high-quality study C. Limited research-based evidence. At least one adequate scientific study. D. No scientific evidence. Expert panel evaluation of other information. METHODS USED TO ANALYZE THE EVIDENCE
DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE
METHODS USED TO FORMULATE THE RECOMMENDATIONS
RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS
COST ANALYSIS
A formal cost analysis was not performed and published cost analyses were not reviewed. METHOD OF GUIDELINE VALIDATION
DESCRIPTION OF METHOD OF GUIDELINE VALIDATION
RECOMMENDATIONS
MAJOR RECOMMENDATIONS
The levels of evidence [A-D] supporting the recommendations are defined at the end of the "Major Recommendations" field. Basic Rules
• A throat swab culture or a rapid test is taken from patients with clear signs of tonsillitis without other respiratory symptoms (usually indicating a viral infection, e.g., rhinitis, cough, hoarseness). • Antibiotics are indicated in infections caused by group A streptococci. • A peritonsillar abscess should be identified and treated immediately. • The following diseases should be recognized: • Granulocytopenia (in patients receiving drugs that affect the bone • The source of infection should be identified in recurrent tonsillitis • Epidemics should be recognized and controlled (even those caused by group C Aetiology of Tonsillitis
• Group A streptococci cause 5 to 20% (during epidemics 40%) of all cases of tonsillitis. Prevalence of tonsillitis is lowest during the summer. • Other streptococci may cause epidemics but no sequelae. • Neisseria gonorrhoeae is a rare cause of tonsillitis (1%). • Mycoplasma and chlamydia are detected equally in asymptomatic as in symptomatic patients, and need not be searched for. • Mononucleosis is diagnosed in 1 to 2% of the patients. • Arcanobacterium is the causative agent in less than 1% of the cases. The clinical picture resembles scarlet fever. No therapy is indicated. • In the majority, sore throat has a viral aetiology. Viruses can cause high Risk Groups
• Streptococci: children above 3 years and young adults (15 to 24 years) • Mononucleosis: children and young adults • Gonorrhea: sexually active individuals Investigations
• Examination of the pharynx: peritonsillar oedema, exudate, trismus • Enlarged lymph nodes in other locations than the jaw angle: • Enlarged, tender thyroid gland: thyroiditis? • Rash: viruses, erythrogenic strains of group A streptococci, • Oedema of the eye lids: mononucleosis? See the Finnish Medical Society Duodecim guideline "Mononucleosis." • Other focuses of infection: sinuses, ears, teeth, lower respiratory tract • Streptococcal culture or rapid test (see picture 1 in the original guideline document) is the most important investigation. Clinical assessment is not accurate in determining the microbial aetiology. • Culture of a throat swab is the most accurate and least expensive method, provided that notification of the result to the patient and delivery of the prescription to the pharmacy are organized effectively. • Streptococcal culture also reveals non-A streptococci (no inhibition of haemolysis around a bacitracin disk). • If a rapid test is used, a negative result (see picture 1 in the original guideline document) should be confirmed by culture (confirmation of a negative test is not necessary in children under the age of 3 years, as streptococcal disease is uncommon in this age group). • Rapid test for mononucleosis and culture for Neisseria gonorrhoeae as Organizing the Treatment
• The physician should see all children and those adults who have an underlying disease, pain in the sinuses or in the ear, productive cough, or trismus. • Adult patients can usually be examined by a nurse, who takes a streptococcal • Antibiotics are indicated only for patients with a positive culture or rapid test • Any streptococci if the symptoms are severe, particularly during an • If the patient has severe symptoms, a one-day dose of antibiotic can be given while waiting for the result of the bacterial culture. If the result is negative, the antibiotic should be discontinued. Drug Therapy in Streptococcal Disease
• Penicillin V 1.5 million units x 2 x 10 • In case of penicillin allergy: oral cephalexin 750 mg x 2 or cefadroxil 1 g x 1 (Deeter et al., 1992) [A].
• It is not necessary to start antibiotics immediately: a delay of 1 (-3) day(s) does not increase complications or delay the resolution of acute disease. • Antibiotics shorten the duration of symptoms somewhat (Del Mar, Glasziou, & Spinks, 2004) [A] and reduce the risk of rheumatic fever (Manyemba &
Mayosi, 2002) [C].
• An analgesic (Thomas, Del Mar, & Glasziou, 2000) [B] (paracetamol and
ibuprofen are the safest) is more effective than antibiotics against symptoms. In adults, pain at swallowing can even be treated with lidocaine spray or gargling solution. • Non-A streptococci: in patients with severe symptoms and during epidemics, the same medication as for group A streptococci. • Repeated throat culture is not necessary unless the symptoms recur. • The patient is no longer infective after 1 day on antibiotics. Drug Therapy for Other Causative Agents
• Pharyngeal gonorrhea often causes only mild symptoms. Remember the provision of free antibiotics for sexually transmitted disease (STD) and tracing of the contacts. • Mononucleosis should not be treated with antibiotics. Particularly ampicillin Peritonsillar Abscess
• Trismus (difficulty and pain in opening the mouth) • Difficulty in swallowing and increased salivation • Oedema around and above the tonsils, deviation of the uvula, asymmetry and • Treatment consists of drainage of the abscess (see figure 2 in the original guideline document) (often immediate tonsillectomy) and antibiotics. Recurrent Tonsillitis
• Recurrent sore throat, with positive test for group A streptococci • Reinfection is the most common cause. • Throat cultures should be taken both from the patient and all family • Other symptomatic patients at the work place should be traced. • In recurrent infection first line therapy is cephalexin or cefadroxil, which erase group A streptococci even more efficiently than penicillin (Deeter, et al 1992)
[A]. Clindamycin (300 mg x 2 for 10 days) also erases group A streptococci
and prevents recurrent tonsillitis caused by other bacteria as well.
Indications for Tonsillectomy
• Recurrent, confirmed bacterial tonsillitis (>4 x/year), irrespective of the type of bacteria (Marshall, 1998) [C]
• Dates and results of bacterial cultures and rapid tests should be • Complications of acute tonsillitis: peritonsillar abscess, septicaemia originating • A peritonsillar abscess in a patient under 40 years of age is treated by acute tonsillectomy without prior incision. • Suspicion of malignancy (marked asymmetry or ulceration) • Airway obstruction caused by tonsils (which may almost touch each other), sleep apnea, disorder of dental occlusion • Chronic tonsillitis is a relative indication for tonsillectomy. The operation is indicated if the patient continuously suffers from bad breath, sore throat, and gagging, and if the symptoms do not diminish during follow-up. Streptococcal Epidemics
• A streptococcal epidemic should be suspected if • There are several patients from the same location OR • The same patient has recurrent streptococcal disease. • Epidemics commonly occur in day-care institutions, schools, and military • If the epidemic is severe, consider the possibility of a food-borne infection. • A nurse should visit the site of the epidemic and take streptococcal culture both from symptomatic and asymptomatic people. • All persons with positive cultures are treated simultaneously and kept away from day care, school, or work for one day after starting treatment whether they have symptoms or not. Symptomatic patients may need a longer sick leave. Control samples are not needed after treatment. • Consider also taking cultures from and treating family members of Related Evidence
A single dose of dexamethasone appears to prevent post-operative vomiting for
many children having their tonsils removed, without adverse effects (Steward,
Welge, & Myer, 2003) [B].
Definitions:
Levels of Evidence
A. Strong research-based evidence. Several relevant, high-quality scientific B. Moderate research-based evidence. At least one relevant, high-quality study C. Limited research-based evidence. At least one adequate scientific study. D. No scientific evidence. Expert panel evaluation of other information. CLINICAL ALGORITHM(S)
EVIDENCE SUPPORTING THE RECOMMENDATIONS
REFERENCES SUPPORTING THE RECOMMENDATIONS
TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS
Concise summaries of scientific evidence attached to the individual guidelines are the unique feature of the Evidence-Based Medicine Guidelines. The evidence summaries allow the clinician to judge how well-founded the treatment recommendations are. The type of supporting evidence is identified and graded for select recommendations (see the "Major Recommendations" field). BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
POTENTIAL BENEFITS
Appropriate diagnosis and treatment of children and adults with sore throat and tonsillitis POTENTIAL HARMS
IMPLEMENTATION OF THE GUIDELINE
DESCRIPTION OF IMPLEMENTATION STRATEGY
An implementation strategy was not provided. INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES
IOM CARE NEED
IOM DOMAIN
IDENTIFYING INFORMATION AND AVAILABILITY
BIBLIOGRAPHIC SOURCE(S)
Finnish Medical Society Duodecim. Sore throat and tonsillitis. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2005 Dec 28 [Various]. [3 references] ADAPTATION
Not applicable: The guideline was not adapted from another source. DATE RELEASED
GUIDELINE DEVELOPER(S)
Finnish Medical Society Duodecim - Professional Association GUIDELINE DEVELOPER COMMENT
SOURCE(S) OF FUNDING
GUIDELINE COMMITTEE
COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE
Primary Authors: Marjukka Makela and Jouko Suonpaa FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST
GUIDELINE STATUS
This is the current release of the guideline. This guideline updates a previous version: Finnish Medical Society Duodecim. Sore throat and tonsillitis. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; 2004 May 13 [Various]. GUIDELINE AVAILABILITY
This guideline is included in a CD-ROM titled "EBM Guidelines. Evidence-Based Medicine" available from Duodecim Medical Publications, Ltd, PO Box 713, 00101 Helsinki, Finland; e-mail: info@ebm-guidelines.com; Web site: www.ebm-guidelines.com. AVAILABILITY OF COMPANION DOCUMENTS
PATIENT RESOURCES
NGC STATUS
This summary was completed by ECRI on August 28, 2001. The information was verified by the guideline developer as of October 26, 2001. This summary was updated by ECRI on December 29, 2003, and again on September 8, 2004. This summary was updated on May 3, 2005 following the withdrawal of Bextra (valdecoxib) from the market and the release of heightened warnings for Celebrex (celecoxib) and other nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI on June 16, 2005, following the U.S. Food and Drug Administration advisory on COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI on March 16, 2006. COPYRIGHT STATEMENT
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. DISCLAIMER
NGC DISCLAIMER
The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at . NGC, AHRQ, and its contractor ECRI make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer. 1998-2006 National Guideline Clearinghouse

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Design of Treatment Trials for Functional GastrointestinalDisordersDesign of Treatment Trials Committee: E. JAN IRVINE,* WILLIAM E. WHITEHEAD,‡WILLIAM D. CHEY,§ KEI MATSUEDA,ʈ MICHAEL SHAW,¶ NICHOLAS J. TALLEY,#,** andSANDER J. O. VELDHUYZEN VAN ZANTEN‡‡*Division of Gastroenterology, St. Michael’s Hospital and University of Toronto, Toronto, Ontario, Canada; ‡Division of Gastroentero

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