Scolaris Content Display Scolaris Content Display

Topical antibiotics for chronic suppurative otitis media

This is not the most recent version

Appendices

Appendix 1. Search strategies

CENTRAL (CRS Web)

MEDLINE (Ovid)

Embase (Ovid)

1 MESH DESCRIPTOR Otitis Media EXPLODE ALL AND CENTRAL:TARGET1061
2 ("otitis media" or OME):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET2347
3 MESH DESCRIPTOR Tympanic Membrane Perforation EXPLODE ALL AND CENTRAL:TARGET71
4 MESH DESCRIPTOR Tympanic Membrane EXPLODE ALL AND CENTRAL:TARGET257
5 ("ear drum*" or eardrum* or tympanic):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET967
6 #4 OR #5 AND CENTRAL:TARGET967
7 (perforat* or hole or ruptur*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET0
8 #6 AND #7 AND CENTRAL:TARGET0
9 #1 OR #2 OR #3 OR #8 AND CENTRAL:TARGET2386
10 MESH DESCRIPTOR Suppuration EXPLODE ALL AND CENTRAL:TARGET891
11 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or discomfort or earach* or mucopurulen*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET90987
12 (pain):AB,TI,TO AND CENTRAL:TARGET87639
13 #10 or #11 or #12 AND CENTRAL:TARGET165103
14 MESH DESCRIPTOR Chronic Disease EXPLODE ALL AND CENTRAL:TARGET11305
15 MESH DESCRIPTOR Recurrence EXPLODE ALL AND CENTRAL:TARGET10431
16 (chronic* or persist* or recurr* or repeat*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET182517
17 #14 OR #15 OR #16 AND CENTRAL:TARGET182523
18 #9 AND #17 AND #13 AND CENTRAL:TARGET378
19 ((chronic* or persist* or recurr* or repeat*) NEAR (ear or ears or aural) NEAR (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort or disease*)):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET0
20 ((earach* near (chronic or persist* or recurr* or repeat*))):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET3
21 MESH DESCRIPTOR Otitis Media, Suppurative EXPLODE ALL AND CENTRAL:TARGET104
22 (CSOM):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET88
23 #20 OR #21 OR #22 OR #18 OR #19 AND CENTRAL:TARGET418

1 exp Otitis Media/

2 ("otitis media" or OME).ab,ti.

3 exp Tympanic Membrane Perforation/

4 exp Tympanic Membrane/

5 ("ear drum*" or eardrum* or tympanic).ab,ti.

6 4 or 5

7 (perforat* or hole or ruptur*).ab,ti.

8 6 and 7

9 1 or 2 or 3 or 4 or 8

10 exp Suppuration/ n

11 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or moist or wet or mucopurulen* or discomfort or pain* or earach*).ab,ti.

12 10 or 11

13 exp Chronic Disease/

14 exp Recurrence/

15 (chronic* or persist* or recurr* or repeat*).ab,ti.

16 13 or 14 or 15

17 9 and 12 and 16

18 ((chronic or persist*) adj3 (ear or ears or aural) adj3 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort)).ab,ti.

19 CSOM.ab,ti.

20 exp Otitis Media, Suppurative/

21 (earach* adj6 (chronic or persist* or recurr* or repeat*)).ab,ti.

22 17 or 18 or 19 or 20 or 21

1 exp otitis media/

2 ("otitis media" or OME).ab,ti.

3 exp eardrum perforation/

4 exp eardrum/

5 ("ear drum*" or eardrum* or tympanic).ab,ti.

6 4 or 5

7 (perforat* or hole or ruptur*).ab,ti.

8 6 and 7

9 1 or 2 or 3 or 8

10 exp suppuration/

11 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or moist or wet or mucopurulen* or discomfort or pain* or earach*).ab,ti.

12 10 or 11

13 exp chronic disease/

14 exp recurrent disease/

15 (chronic* or persist* or recurr* or repeat*).ab,ti.

16 13 or 14 or 15

17 9 and 12 and 16

18 exp suppurative otitis media/

19 CSOM.ab,ti.

20 ((chronic or persist*) adj3 (ear or ears or aural) adj3 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort or disease*)).ab,ti.

21 (earach* adj3 (chronic or persist* or recurr* or repeat*)).ab,ti.

22 17 or 18 or 19 or 20 or 21

Web of Science (Web of Knowledge)

CINAHL (EBSCO)

Cochrane ENT Register (CRS Web)

#1 TOPIC: ("otitis media" or OME)

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#2 TOPIC: (("ear drum*" or eardrum* or tympanic) AND (perforat* or hole or ruptur*))

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#3 #2 OR #1

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#4 TOPIC: ((suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or moist or wet or mucopurulen* or discomfort or pain* or earach*) AND (chronic* or persist* or recurr* or repeat*))

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#5 #4 AND #3

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#6 TOPIC: (((chronic or persist*) NEAR/3 (ear or ears or aural) NEAR/3 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort)))

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#7 TOPIC: ((earach* NEAR/3 (chronic or persist* or recurr* or repeat*)))

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

#8 #7 OR #6 OR #5

Indexes=SCI‐EXPANDED, SSCI, A&HCI, CPCI‐S, CPCI‐SSH, BKCI‐S, BKCI‐SSH, ESCI, CCR‐EXPANDED, IC Timespan=All years

S21 S17 OR S18 OR S19 OR S20

S20 TX ((chronic or persist*) N3 (ear or ears or aural) N3 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort))

S19 TX (earach* N3 (chronic or persist* or recurr* or repeat*))

S18 TX csom

S17 S9 AND S12 AND S16

S16 S13 OR S14 OR S15

S15 TX chronic* or persist* or recurr* or repeat*

S14 (MH "Recurrence")

S13 (MH "Chronic Disease")

S12 S10 OR S11

S11 TX suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or moist or wet or mucopurulen* or discomfort or pain* or earach*)

S10 (MH "Suppuration+")

S9 S1 OR S2 OR S3 OR S8

S8 S6 AND S7

S7 TX perforat* or hole or ruptur*

S6 S4 OR S5

S5 TX "ear drum*" or eardrum* or tympanic

S4 (MH "Tympanic Membrane")

S3 (MH "Tympanic Membrane Perforation")

S2 TX "otitis media" or OME

S1 (MH "Otitis Media+")

1 ("otitis media" or OME):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

2 (("ear drum*" or eardrum* or tympanic)):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

3 (perforat* or hole or ruptur*):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

4 #2 AND #3 AND INREGISTER

5 #4 OR #1 AND INREGISTER

6 (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or discomfort or earach* or mucopurulen*):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

7 (pain):AB,TI,TO AND INREGISTER

8 #6 OR #7 AND INREGISTER

9 (chronic* or persist* or recurr* or repeat*):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

10 #5 AND #8 AND #9 AND INREGISTER

11 (csom):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

12 (((chronic* or persist* or recurr* or repeat*) and (ear or ears or aural) and (suppurat* or pus or purulen* or discharg* or mucosal or otorrh* or otorh* or otoliquor* or active or weep* or wet or moist or mucopurulen* or pain* or discomfort or disease*))):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

13 ((earach* and (chronic or persist* or recurr* or repeat*))):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER

14 #10 OR #11 OR #12 OR #13 AND INREGISTER

ClinicalTrials.gov (CRS Web)

ICTRP (WHO Portal)

Other

Search 1:

(chronic OR persistent OR recurrence OR recurrent) AND (suppuration OR pus OR discharge OR otorrhea or active OR mucopurulent)

AND

Condition: "Otitis Media" OR OME

AND

Study type: interventional

Search 2:

(chronic OR persistent OR recurrence OR recurrent) AND (earache OR "ear ache" OR "ear pain" OR "ear discharge" OR "wet ear" OR "moist ear" OR "weeping ear")

AND

Study type: interventional

Search 3:

("ear drum" OR eardrum OR "tympanic membrane") AND (hole OR perforation OR rupture)

AND

Study type: interventional

otitis media AND chronic OR ear discharge OR earache OR wet ear OR weeping ear OR moist ear OR CSOM OR OME AND chronic OR tympanic membrane AND perforation OR eardrum AND hole OR eardrum AND perforation

LILACS

TW:"otitis media" OR "TW:"ear discharge" OR TW:earache OR ((TW:eardrum OR TW:tympanic) AND (TW:perforation OR hole)) OR ((TW:wet OR moist OR weeping) AND TW:ear)

AND:

Filter: Controlled Clinical Trial

IndMed

otitis media OR ear discharge OR csom OR earache OR wet ear OR tympanic membrane perforation OR eardrum hole OR wet ear OR weeping ear or moist ear OR OME

PakMediNet

otitis media | ear discharge | csom | earache | wet ear | tympanic membrane perforation | eardrum hole | wet ear | weeping ear

African Index Medicus

"otitis media"

OR

"ear discharge"

OR

CSOM

Appendix 2. Data extraction form

REF ID:

Study title:

Date of extraction:

Extracted by:

Name and email address of correspondence authors:

General comments/notes (internal for discussion):

FLOW CHART OF TRIAL:

Intervention

( name the intervention)

Comparison

( name the intervention)

No. of people screened

No. of participants randomised ‐ all

No. randomised to each group

No. receiving treatment as allocated

No. not receiving treatment as allocated

‐ Reason 1

‐ Reason 2

No. that dropped out1

(no follow‐up data for any outcome available)

No. excluded from analysis2 (for all outcomes)

‐ Reason 1

‐ Reason 2

1This includes patients who withdrew and provided no data, or did not turn up for follow‐up.
2This should be the people who were excluded from all analyses (e.g. because the data could not be interpreted or the outcome was not recorded for some reason). This is the number of people who dropped out, plus the people who were excluded by the authors for some reason (e.g. non‐compliant).

INFORMATION TO GO INTO THE 'CHARACTERISTICS OF INCLUDED STUDIES' TABLE:

Methods

X arm, double‐/single‐/non‐blinded, [multicentre] parallel‐group/cross‐over/cluster RCT, with x duration of treatment and x duration of follow‐up

Participants

Location: [country, rural?, no. of sites etc.]

Setting of recruitment and treatment: [specialist hospital? general practice? school? state YEAR]

Sample size:

  • Number randomised: x in intervention, y in comparison

  • Number completed: x in intervention, y in comparison

Participant (baseline) characteristics:

  • Age:

  • Gender (F/M): number of females (%)/number of males (%)

  • Main diagnosis: [as stated in paper – state the diagnostic criteria used]

  • High risk population: Yes/No

    • Cleft palate (or other craniofacial malformation): y/N (%)

    • Down syndrome: n/N (%)

    • Indigenous groups (Australian Aboriginals/Greenland natives): n/N (%)

    • Immunocompromised: n/N (%)

  • Diagnosis method [if reported]:

    • Confirmation of perforated tympanic membrane: Yes/No/NR or unclear[Method]

    • Presence of mucopurulent discharge: Yes/No/NR or unclear – if 'yes', record n/N (%)

    • Duration of symptoms (discharge): x weeks

  • Other important effect modifiers, if data available:

    • Alternative diagnosis of ear discharge (where known): n/N (%)

    • Number who have previously had grommets inserted (and, where known, number where grommets are still in place): n/N (%)

    • Number who have had previous ear surgery: n/N (%)

    • Number who have had previous antibiotic treatment for CSOM: n/N (%)

Inclusion criteria:

  • [State diagnostic criteria used for CSOM, if available]

Exclusion criteria:

Interventions

Intervention (n = x): drug name, method of administration, dose per day/frequency of administration, duration of treatment

For aural toileting: who does it, methods or tools used, frequency, duration

Comparator group (n = y):

Concurrent treatment:

Use of additional interventions (common to both treatment arms):

Outcomes

Outcomes of interest in the review:

Primary outcomes:

  • Resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between 1 week to 2 weeks, 2 to 4 weeks and after 4 weeks

  • Health‐related quality of life using a validated instrument (e.g. COMQ‐12, COMOT‐15, CES)

  • Ear pain (otalgia) or discomfort or local irritation

Secondary outcomes

  • Hearing, measured as the pure‐tone average of air conduction thresholds across 4 frequencies tested (at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz), of the affected ear. If this is not available, the pure‐tone average of the thresholds measured.

  • Serious complications, including intracranial complications (such as otitic meningitis, lateral sinus thrombosis and cerebellar abscess) and extracranial complications (such as mastoid abscess, postauricular fistula and facial palsy), and death.

  • Adverse effects from treatment (this will be dependent on the type of treatment reviewed).

Funding sources

"No information provided"/"None declared"/State source of funding

Declarations of interest

"No information provided"/"None declared"/State conflict

Notes

Clinical trial registry no: (if available)

Unit of randomisation: person/ears/other (e.g. cluster‐randomised by hospital/school)

[In the case of randomisation by person]:

Methods for including patients with bilateral disease, for example:

  • Random selection of one ear as the 'study ear'

  • Selecting worse/least affected ear as the 'study ear'

  • Counting bilateral ears separately

  • Reporting 2 sets of results (please specify)

  • Other (please state)

  • Not stated

RISK OF BIAS TABLE:

(See table 8.5d in the Cochrane Handbook for Systematic Reviews of Interventions: http://handbook.cochrane.org/).

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High/low/unclear risk

Quote: "…"

Comment:

Allocation concealment (selection bias)

High/low/unclear risk

Quote: "…"

Comment:

Blinding of participants and personnel (performance bias)

High/low/unclear risk

Quote: "…"

Comment:

Blinding of outcome assessment (detection bias)

High/low/unclear risk

Quote: "…"

Comment:

Incomplete outcome data (attrition bias)

High/low/unclear risk

Quote: "…"

Comment:

Selective reporting (reporting bias)

High/low/unclear risk

Quote: "…"

Comment:

FINDINGS OF STUDY

CONTINUOUS OUTCOMES

Results (continuous data table)

Outcome

Intervention

(name the intervention)

Comparison

(name the intervention)

Other summary statistics/Notes

Mean

SD

N

Mean

SD

N

Mean difference (95% CI), P values etc.

Disease‐specific health‐related quality of life

(COMQ‐12, COMOT‐15, CES)1

Time point: (state)

Hearing:

[Measurement method: include frequencies and report results separately if they are presented in the paper]

Time point: [xx]

Comments:

[If there is no information apart from (vague) narration, quote here]

[If information is in the form of graphs, used this software to read it: http://arohatgi.info/WebPlotDigitizer/app/, and save a copy of your charts in a folder]

1State the measurement method: this will be instrument name/range for patient‐reported outcomes.

DICHOTOMOUS OUTCOMES

Results (dichotomous data table)

Outcome

Applicable review/

Intervention1

Group A ‐ intervention arm

Group B – control

Other summary statistics/Notes

No. of people with events

No. of people analysed

No. of people with events

No. of people analysed

P values, RR (95% CI), OR (95% CI)

Resolution of ear discharge or 'dry ear' at 1 to 2 weeks

[Measurement method or definition used: not/unclear if/otoscopically confirmed]1

Time point: [State actual time point]

Resolution of ear discharge or 'dry ear' at 2 to 4 weeks

[Measurement method or definition used: not/unclear if/otoscopically confirmed]

Time point: [xx]

Resolution of ear discharge or 'dry ear' after 4 weeks

[Measurement method or definition used: not/unclear if/otoscopically confirmed]

Time point: [xx]

Ear pain/discomfort/local irritation
[Measurement method or definition used e.g. patient‐reported]

Time point: [xx]

Suspected ototoxicity

[Measurement method or definition used]

Time point: [xx]

Sensorineural hearing loss

[Measurement method or definition used]

Time point: [xx]

Tinnitus

[Measurement method or definition used]

Time point: [xx]

Dizziness/vertigo/balance

[Measurement method or definition used]

Time point: [xx]

Serious complications:
[State whether the paper had prespecified looking for this event, how it was diagnosed]

Time point: state length of follow‐up of the trial

Note down the page number /table where info was found for ease of checking

Otitic meningitis

[How was this diagnosed?]

Lateral sinus thrombosis

[How was this diagnosed?]

Cerebellar abscess

[How was this diagnosed?]

Mastoid abscess/mastoiditis

[How was this diagnosed?]

Postauricular fistula

[How was this diagnosed?]

Facial palsy

[How was this diagnosed?]

Other complications

[How was this diagnosed?]

Death

[How was this diagnosed?]

Multiple serious complications

[How was this diagnosed?]

Comment/additional notes:

If any calculations are needed to arrive at the data above, note this down here.

1State briefly how this was measured in the study, especially whether there was deviation from what was expected in the protocol.

For adverse events, note down how these were collected, e.g. whether the adverse event was one of the prespecified events that the study planned to collect, when it was collected and how/who measured it (e.g. as reported by patients, during examination and whether any scoring system was used).

Table 1. Table of Cochrane Reviews

Topical antibiotics with steroids

Topical antibiotics

Systemic antibiotics

Topical antiseptics

Aural toileting (ear cleaning)

Topical antibiotics with steroids

Review CSOM‐4

Topical antibiotics

Review CSOM‐4

Review CSOM‐1

Systemic antibiotics

Review CSOM‐4

Review CSOM‐3

Review CSOM‐2

Topical antiseptics

Review CSOM‐4

Review CSOM‐6

Review CSOM‐6

Review CSOM‐5

Aural toileting

Review CSOM‐4

Not reviewed

Not reviewed

Not reviewed

Review CSOM‐7

Placebo (or no intervention)

Review CSOM‐4

Review CSOM‐1

Review CSOM‐2

Review CSOM‐5

Review CSOM‐7

CSOM‐1: Topical antibiotics for chronic suppurative otitis media (Brennan‐Jones 2018a).

CSOM‐2: Systemic antibiotics for chronic suppurative otitis media (Chong 2018a).

CSOM‐3: Topical versus systemic antibiotics for chronic suppurative otitis media (Chong 2018b).

CSOM‐4: Topical antibiotics with steroids for chronic suppurative otitis media (Brennan‐Jones 2018b).

CSOM‐5: Topical antiseptics for chronic suppurative otitis media (Head 2018a).

CSOM‐6: Antibiotics versus topical antiseptics for chronic suppurative otitis media (Head 2018b).

CSOM‐7: Aural toilet (ear cleaning) for chronic suppurative otitis media (Bhutta 2018).

Figures and Tables -
Table 1. Table of Cochrane Reviews
Table 2. Examples of antibiotics classes and agents with anti‐Pseudomonas activity

Class of antibiotics

Examples

Route of administration

Quinolones

Ciprofloxacin, ofloxacin, levofloxacin

Oral, intravenous, topical

Aminoglycosides

Gentamicin, tobramycin

Topical or parenteral

Neomycin/framycetin

Only topical

Cephalosporins

Ceftazidime

Parenteral

Penicillins

Ticarcillin plus clavulanic acid

Parenteral

Monobactams

Aztreonam

Parenteral

Figures and Tables -
Table 2. Examples of antibiotics classes and agents with anti‐Pseudomonas activity