scholarly journals Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCT

2021 ◽  
Vol 25 (67) ◽  
pp. 1-76
Author(s):  
Alastair D Hay ◽  
Michael V Moore ◽  
Jodi Taylor ◽  
Nicholas Turner ◽  
Sian Noble ◽  
...  
Keyword(s):  
Primary Care ◽  
Otitis Media ◽  
Symptom Management ◽  
Acute Otitis Media ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Symptom Duration ◽  
Oral Antibiotics ◽  
Topical Antibiotics ◽  
Internal Pilot

Background Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. Objective To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. Design This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. Setting A total of 44 English general practices. Participants Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. Interventions (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed ‘dose-by-age’ amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. Comparator Immediate ‘dose-by-age’ oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. Main outcome measure Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated ‘no’ or ‘very slight’ problem (without need for analgesia). Methods Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. Results Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4–9), 4 (3–7) and 4 (3–6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. Limitations The over-riding weakness was the failure to recruit enough children. Conclusions We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. Trial registration Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.

scholarly journals A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

2020 ◽  
Author(s):  
Kathryn Curtis ◽  
Jodi Taylor ◽  
Alastair Hay ◽  
Michael Moore ◽  
Richard Morris ◽  
...  
Keyword(s):  
Primary Care ◽  
Data Collection ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
World Health ◽  
Oral Antibiotics ◽  
Management Platform ◽  
Oral Amoxicillin ◽  
The Uk

Abstract Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd.Methods: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months. Discussion: It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. Trial registration:Name of Registry: ISCRTNRegistration Number: ISRCTN12873692 This contains all items required to comply with the World Health Organization Trial Registration Data SetDate of Registration: 24th April 2018 http://www.isrctn.com/ISRCTN12873692Name of Registry: EudraCT Registration Number: 2017-003635-10Date of Registration: 6TH September 2017

scholarly journals A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

2020 ◽  
Author(s):  
Kathryn Curtis ◽  
Michael Moore ◽  
Christie Cabral ◽  
Vasa Curcin ◽  
Jeremy Horwood ◽  
...  
Keyword(s):  
Primary Care ◽  
Data Collection ◽  
Otitis Media ◽  
Workflow Management ◽  
Acute Otitis Media ◽  
Oral Antibiotics ◽  
Trial Management ◽  
Management Platform ◽  
Oral Amoxicillin ◽  
The Uk

Abstract Background Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd. Methods REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months. Discussion It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.

Spectrophotometric Otoscope: A New Tool in the Diagnosis of Otitis Media

2007 ◽  
Vol 15 (4) ◽  
pp. 209-215 ◽  
Author(s):  
Zeev Schmilovitch ◽  
Victor Alchanatis ◽  
Menashe Shachar ◽  
Yehud Holdstein
Keyword(s):  
Primary Care ◽  
Otitis Media ◽  
Primary Care Physicians ◽  
Acute Otitis Media ◽  
Care Physician ◽  
Public Healthcare ◽  
Least Squares Regression ◽  
Double Blind ◽  
Diagnostic Aid ◽  
Serous Otitis Media

Otitis media is one of the most common childhood ailments and, therefore, has a significant impact on public healthcare expenditure. The initial diagnosis is usually performed by a primary-care physician and is based upon otoscopy and symptomatology; the certainty of diagnosis of acute otitis media is only 58–73%. This study aimed to assess the efficacy of a spectrophotometer-based system in identifying otitis media by comparing the output from the system with the clinical diagnosis of an experienced otologist and, hence, to evaluate the system as a diagnostic aid to primary-care physicians. The study was prospective and double blind. An otologist examined 258 patients consecutively with an oto-microscope and all of the patients were simultaneously examined with a spectrometer-based data acquisition system incorporated in a standard otoscope. The otologist's diagnosis served as a “gold standard”. The acquired data were analysed by means of partial least squares regression. The system correctly differentiated acute otitis media from serous otitis media and normal ears with sensitivity of 93% and specificity of 88%. The sensitivity and specificity were 89 and 95%, respectively, in a subset of subjects aged 12 y or less. Spectrophotometry was found to be a highly accurate means of diagnosing acute otitis media. We consider that it will become an important diagnostic aid for primary care physicians.

scholarly journals Antimicrobials for acute otitis media? a review from the international primary care network

BMJ ◽  
1997 ◽  
Vol 315 (7100) ◽  
pp. 98-102 ◽  
Author(s):  
J. Froom ◽  
L. Culpepper ◽  
M. Jacobs ◽  
R. A DeMelker ◽  
L. A Green ◽  
...  
Keyword(s):  
Primary Care ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Care Network
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