Lavado ótico (limpieza de oído) para la otitis media supurativa crónica
Appendices
Appendix 1. Search strategies
| CENTRAL (the Cochrane Register of Studies) | MEDLINE (Ovid) | Embase (Ovid) |
|---|---|---|
| 1 MESH DESCRIPTOR Otitis Media EXPLODE ALL AND CENTRAL:TARGET | 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 (the Cochrane Register of Studies) |
| #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 | ICTRP (WHO Portal) | Other |
| Search 1 (clinicaltrials.gov): (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 (clinicaltrials.gov): (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 (clinicaltrials.gov): ("ear drum" OR eardrum OR "tympanic membrane") AND (hole OR perforation OR rupture) AND Study type: interventional Search 4 (the Cochrane Register of Studies): 1 ("otitis media" or OME):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 2 (("ear drum*" or eardrum* or tympanic)):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 3 (perforat* or hole or ruptur*):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 4 #2 AND #3 AND INSEGMENT 5 #4 OR #1 AND INSEGMENT 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 INSEGMENT 7 (pain):AB,TI,TO AND INSEGMENT 8 #6 OR #7 AND INSEGMENT 9 (chronic* or persist* or recurr* or repeat*):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 10 #5 AND #8 AND #9 AND INSEGMENT 11 (csom):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 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 INSEGMENT 13 ((earach* and (chronic or persist* or recurr* or repeat*))):AB,EH,KW,KY,MC,MH,TI,TO AND INSEGMENT 14 #10 OR #11 OR #12 OR #13 AND INSEGMENT 15 (nct*):AU AND INSEGMENT 16 #14 AND #15 | 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 Chronic Suppurative Otitis Media OR Chronic Otitis Media OR CSOM African Index Medicus “chronic suppurative otitis media" OR "chronic otitis media“ OR CSOM |
In addition to the strategy above (which was applied to the six other reviews in this CSOM suite) we also carried out the following supplementary searches, which we did not combine with a randomised controlled trial filter and which excluded the references retrieved with the above searches.
| CENTRAL (the Cochrane Register of Studies) | Cochrane ENT Register (the Cochrane Register of Studies) | MEDLINE (Ovid) |
|---|---|---|
| 1 MESH DESCRIPTOR Ear EXPLODE ALL AND CENTRAL:TARGET 2 MESH DESCRIPTOR Ear Diseases EXPLODE ALL AND CENTRAL:TARGET 3 (("otitis media" or OME)):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 4 MESH DESCRIPTOR Tympanic Membrane Perforation EXPLODE ALL AND CENTRAL:TARGET 5 MESH DESCRIPTOR Tympanic Membrane EXPLODE ALL AND CENTRAL:TARGET 6 ("ear drum*" or eardrum* or tympanic):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 7 #5 OR #6 8 ((perforat* or hole or ruptur*).):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 9 #7 AND #8 10 #2 OR #1 OR #3 OR #4 OR #9 11 MESH DESCRIPTOR Suppuration EXPLODE ALL AND CENTRAL:TARGET 12 (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:TARGET 13 (pain*):AB,TI AND CENTRAL:TARGET 14 #12 OR #11 OR #13 15 #14 AND #10 16 MESH DESCRIPTOR Otitis Media, Suppurative EXPLODE ALL AND CENTRAL:TARGET 17 (CSOM or earach*):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 18 (((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))):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 19 #16 OR #15 OR #17 OR #18 20 (((ear or ears or aural) near (toilet* or care or hygiene or syring* or irrigat* or probe or swab* or wash* or clean* or clear* or suck or suction))):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 21 ((microsuction* or propulse or "pro pulse")):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 22 ((dry near mop*)):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 23 (((cotton or tissue) near (wool or bud or spear*))):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 24 ((chrome near syring*)):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 25 ((jobson near horn)):AB,EH,KW,KY,MC,MH,TI,TO AND CENTRAL:TARGET 26 #20 OR #21 OR #22 OR #23 OR #24 OR #25 27 #26 AND #19 | 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 or earach*):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 12 (((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))):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 13 #10 OR #11 OR #12 AND INREGISTER 14 (((ear or ears or aural) near (toilet* or care or hygiene or syring* or irrigat* or probe or swab* or wash* or clean* or clear* or suck or suction))):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 15 ((microsuction* or propulse or "pro pulse")):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 16 ((dry near mop*)):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 17 (((cotton or tissue) near (wool or bud or spear*))):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 18 ((jobson near horn)):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 19 ((chrome near syring*)):AB,EH,KW,KY,MC,MH,TI,TO AND INREGISTER 20 #15 OR #14 OR #16 OR #17 OR #19 OR #18 AND INREGISTER 21 #13 AND #20 AND INREGISTER | 1 exp Ear Diseases/ 2 exp Ear/ 3 ("otitis media" or OME).ab,ti. 4 exp Tympanic Membrane Perforation/ 5 exp Tympanic Membrane/ 6 ("ear drum*" or eardrum* or tympanic).ab,ti. 7 5 or 6 8 (perforat* or hole or ruptur*).ab,ti. 9 7 and 8 10 1 or 2 or 3 or 4 or 9 11 exp Suppuration/ 12 (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. 13 11 or 12 14 10 and 13 15 exp Otitis Media, Suppurative/ 16 (CSOM or earach*).ab,ti. 17 ((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. 18 14 or 15 or 16 or 17 19 ((ear or ears or aural) adj3 (toilet* or care or hygiene or syring* or irrigat* or probe or swab* or wash* or clean* or clear* or suck or suction)).ab,ti. 20 (microsuction* or propulse or "pro pulse").ab,ti. 21 (dry adj3 mop*).ab,ti. 22 ((cotton or tissue) adj3 (wool or bud or spear*)).ab,ti. 23 (jobson adj3 horn).ab,ti. 24 (chrome adj3 syring*).ab,ti. 25 19 or 20 or 21 or 22 or 23 or 24 26 18 and 25 |
| Embase (Ovid) | CINAHL (EBSCO) | |
| 1 exp ear disease/ 2 exp ear/ 3 ("otitis media" or OME).ab,ti. 4 exp eardrum perforation/ 5 exp eardrum/ 6 ("ear drum*" or eardrum* or tympanic).ab,ti. 7 5 or 6 8 (perforat* or hole or ruptur*).ab,ti. 9 7 and 8 10 1 or 2 or 3 or 4 or 9 11 exp suppuration/ 12 (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. 13 11 or 12 14 10 and 13 15 exp suppurative otitis media/ 16 (CSOM or earach*).ab,ti. 17 ((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. 18 14 or 15 or 16 or 17 19 ((ear or ears or aural) adj3 (toilet* or care or hygiene or syring* or irrigat* or probe or swab* or wash* or clean* or clear* or suck or suction)).ab,ti. 20 (microsuction* or propulse or "pro pulse").ab,ti. 21 (dry adj3 mop*).ab,ti. 22 ((cotton or tissue) adj3 (wool or bud or spear*)).ab,ti. 23 (jobson adj3 horn).ab,ti. 24 (chrome adj3 syring*).ab,ti. 25 19 or 20 or 21 or 22 or 23 or 24 26 18 and 25 | S25 S17 AND S24 S24 S18 OR S19 OR S20 OR S21 OR S22 OR S23 S23 TX (chrome N3 syring*) S22 TX (chrome N3 syring*) S21 TX ((cotton or tissue) N3 (wool or bud or spear*)) S20 TX dry N3 mop*) S19 TX (microsuction* or propulse or "pro pulse") S18 TX ((ear or ears or aural) N3 (toilet* or care or hygiene or syring* or irrigat* or probe or swab* or wash* or clean* or clear* or suck or suction)) S17 S14 OR S15 OR S16 S16 TX ((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)) S15 TX CSOM or earach* S14 S10 AND S13 S13 S11 OR S12 S12 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*) S11 (MH "Suppuration+") S10 S1 OR S2 OR S3 OR S4 OR S9 S9 S7 AND S8 S8 TX perforat* or hole or ruptur* S7 S5 OR S6 S6 TX "ear drum*" or eardrum* or tympanic S5 (MH "Tympanic Membrane") S4 (MH "Tympanic Membrane Perforation") S3 TX "otitis media" or OME S2 (MH "Ear+") S1 (MH "Ear Diseases+") | — |
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:
Participant (baseline) characteristics:
Inclusion criteria:
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:
Secondary outcomes
|
| 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:
|
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 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: 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).
Process for sifting search results and selecting studies for inclusion.
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Aural toileting versus no aural toileting, Outcome 1: Resolution of ear discharge (4 weeks +)
Comparison 2: Daily aural toileting versus single aural toileting, Outcome 1: Resolution of ear discharge (1 to 2 weeks)
Comparison 2: Daily aural toileting versus single aural toileting, Outcome 2: Vertigo/dizziness/tinnitus
| Aural toileting compared to no aural toileting for chronic suppurative otitis media | |||||||
| Patient or population: children with chronic suppurative otitis media | |||||||
| Outcomes | Relative effect | Number of participants (studies) | Anticipated absolute effects* (95% CI) | Certainty of the evidence | What happens | ||
|---|---|---|---|---|---|---|---|
| Without aural toileting | With aural toileting | Difference | |||||
| Resolution of ear discharge ‐ 1 to 2 weeks | No study reported this outcome at this time point. | ||||||
| Resolution of ear discharge ‐ 4 weeks or more Assessed by: otoscopically confirmed Follow‐up: 16 weeks | RR 1.01 (0.60 to 1.72) | 217 | Study population | ⊕⊝⊝⊝ | We are uncertain about the effect of aural toileting on resolution of ear discharge (at 4 weeks or more) compared with no treatment. | ||
| 22.2% | 22.4% | 0.2% more | |||||
| Health‐related quality of life | No study reported this outcome. | ||||||
| Ear pain (otalgia) or discomfort or local irritation | No study reported this outcome. | ||||||
| Hearing | Hearing was measured in one study but the results were presented by treatment outcome rather than by treatment group, so it is not possible to determine whether there is a difference between the two groups. | ||||||
| Serious complications | — | 48 (1 RCT) | One study reported one case of mastoiditis and one case of meningitis with focal encephalitis. It is not clear which group these patients were from (the study was a five‐arm trial of which only two arms are presented here), or whether the complications occurred pre‐ or post‐treatment. | ⊕⊝⊝⊝ | We are very uncertain about the effect of aural toileting on serious complications compared with no treatment. | ||
| Adverse events: dizziness/vertigo/balance problems | No study reported this outcome. | ||||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||||
| GRADE Working Group grades of evidence | |||||||
| 1Downgraded to very low certainty: downgraded by one level due to study limitations (risk of bias) because there was unclear allocation concealment, attrition bias and selective reporting bias. Downgraded by one level for indirectness (only children were included in the study). Downgraded by two levels for imprecision (as the results are based on one small study with wide confidence intervals). Downgraded by one level for suspected publication bias (this area has a known issue with trials not being published in peer‐reviewed journals). 2Downgraded to very low certainty: downgraded by one level due to study limitations (risk of bias) because it was at high risk of bias for randomisation and was at unclear risk of bias for allocation concealment, attrition bias and selective reporting bias. The study was unblinded. Downgraded by one level for indirectness (only children were included in the study). Downgraded by two levels for imprecision as it was not clear to which group the events could be attributed. Downgraded by one level for suspected publication bias (this area has a known issue with trials not being published in peer‐reviewed journals). | |||||||
| Daily aural toileting compared to single aural toileting episode for chronic suppurative otitis media | |||||||
| Patient or population: people (of any age) with otorrhoea for a duration of at least 6 weeks | |||||||
| Outcomes | Relative effect | Number of participants (studies) | Anticipated absolute effects* (95% CI) | Certainty of the evidence | What happens | ||
|---|---|---|---|---|---|---|---|
| Single aural toileting | Daily aural toileting | Difference | |||||
| Resolution of ear discharge ‐ 1 to 2 weeks Assessed by: unknown ‐ unclear if otoscopically confirmed | RR 1.09, (0.91 to 1.30) | 80 (1 RCT) | Study population | ⊕⊝⊝⊝ | We are uncertain about the effect of daily aural toileting on resolution of ear discharge (at 1 to 2 weeks) compared with single episode of aural toileting. | ||
| 82.5% | 89.9% (75.1 to 100) | 7.4% more (7.4% fewer to 17.5% more) | |||||
| Resolution of ear discharge ‐ 4 weeks or more Assessed by: unknown ‐ unclear if otoscopically confirmed Follow‐up: 3 months | Kiris 1998 provided results for this outcome by ear, but the results could not be adjusted to provide results per person. | ||||||
| Health‐related quality of life | No study reported this outcome. | ||||||
| Ear pain (otalgia) or discomfort or local irritation | No study reported this outcome. | ||||||
| Hearing | — | 80 (1 RCT) | Results were only reported qualitatively, the report stating that "there were no differences in pre‐ and post audiographic results or bone conduction in either group ..." | ⊕⊝⊝⊝ | We are uncertain about the effect of daily aural toileting on hearing compared with a single episode of aural toileting. | ||
| Serious complications | The study did not report that any participant died or had any intracranial or extracranial complications. | ||||||
| Adverse events: dizziness Assessed by: self reported Follow‐up: 15 days | RR 0.33, (0.01 to 7.95) | 80 (1 RCT) | Study population | ⊕⊝⊝⊝ | We are uncertain about the effect of daily aural toileting on dizziness compared with a single episode of aural toileting. | ||
| 2.5% | 0.8% (0% to 19.9%) | 1.7% less (2.5% fewer to 17.4% more) | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||||
| GRADE Working Group grades of evidence | |||||||
| 1Downgraded to very low certainty: downgraded by two levels due to risk of bias (unclear randomisation, allocation concealment, unblinded trial and possible selective reporting). Downgraded by one level due to indirectness: the population is people with otorrhoea for more than six weeks so it is unclear if all included patients had CSOM. Downgraded by one level due to imprecision: the results are from one small study so the confidence intervals are wide. 2Downgraded to very low certainty: downgraded by two levels due to risk of bias (unclear randomisation, allocation concealment, unblinded trial and possible selective reporting). Downgraded by one level due to indirectness: the population is those with otorrhoea so it is unclear if all included patients had CSOM. Downgraded by two levels due to imprecision: the results are from one small study and only reported qualitatively. 3Downgraded to very low certainty: downgraded by two levels due to risk of bias (unclear randomisation, allocation concealment, unblinded trial and possible selective reporting). Downgraded by one level due to indirectness: the population is those with otorrhoea so it is unclear if all included patients had CSOM. Downgraded by two levels due to imprecision: the results are from one small study and only one event was reported resulting in very wide confidence intervals. | |||||||
| 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 2020). 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 2020a). CSOM‐6: Antibiotics versus topical antiseptics for chronic suppurative otitis media (Head 2020b). CSOM‐7: Aural toilet (ear cleaning) for chronic suppurative otitis media (Bhutta 2018). | |||||
| Ref ID (no. of participants) | Setting | Population | Intervention | Comparison | Treatment | Follow‐up | Background treatment | Notes |
|---|---|---|---|---|---|---|---|---|
| Daily dry mopping versus no specific treatment | ||||||||
| (n = 48 people, 67 ears) | Solomon Islands, villages (community) | Children with CSOM for more than 3 months Mean age 5.4 years | 4 times daily aural toilet (dry mopping) | No treatment | 3 to 6 weeks | 6 weeks | None | Part of a 5‐arm trial |
| (n = 303 people) | Kenya (school) | Children with CSOM for more than 2 weeks Mean age not given. 80% of children were between 5 and 14 years. | Twice daily dry mopping (except weekends) | No specific treatment | Up to 16 weeks | Up to 16 weeks | None | Part of a 3‐arm trial |
| Daily suction cleaning PLUS topical antibiotics versus single suction cleaning PLUS topical antibiotics | ||||||||
| (n = 80 people, 95 ears) | Turkey (ENT clinic) | Otorrhoea with at least 6 weeks duration Mean: 26.5 years (range 21 months to 70 years) | Daily external ear channel aspiration | Single external ear channel aspiration at first visit | 15 days | 3 to 6 months | Topical ciprofloxacin | — |
| CSOM: chronic suppurative otitis media | ||||||||
| Reference | Unit of randomisation | Reported | Definition | Otoscopically confirmed? | Time points | Notes |
|---|---|---|---|---|---|---|
| Person | Ear | "dry" or "not discharging" | Unclear | 2 to 4 weeks (3 weeks) 4+ weeks (6 weeks) | Although the results were presented by ear, sensitivity analysis based on converting the results to people did not affect the outcome so we used the results in this review. | |
| Person | Ear, person could be determined | Resolution of otorrhoea | Unclear | 1 to 2 weeks (between 3 to 12 days of treatment) | The results are presented by ear but sufficient data existed to provide the data by person. The base case assumption is that most of the cases were unilateral disease, which provides the most conservative estimate of effect size. | |
| School | Person | "resolution": absence of otorrhoea at 2 successive visits "healed": complete repair of the | Otoscopically confirmed | 4+ weeks (16 weeks) | — |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Resolution of ear discharge (4 weeks +) Show forest plot | 1 | 217 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.01 [0.60, 1.72] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Resolution of ear discharge (1 to 2 weeks) Show forest plot | 1 | 80 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.91, 1.30] |
| 2.2 Vertigo/dizziness/tinnitus Show forest plot | 1 | 80 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.01, 7.95] |
