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Unilateral versus bilateral hearing aids for bilateral hearing impairment in adults

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Appendices

Appendix 1. Draft search strategies

MEDLINE (Ovid)

Embase (Ovid)

CENTRAL

1 exp Hearing Loss/

2 (hearing adj2 (loss* or impair* or partial* or deficit* or deteriorat* or degenerat* or diminish* or difficult* or disabilit* or hard or one side* or unilateral)).ti,ab.

3 deaf*.ti,ab.

4 (hypoacus* or presbycus* or presbyacus* or sociocus* or nosocus* or anacus*).ti,ab.

5 Persons With Hearing Impairments/

6 or/1‐5

7 letter/

8 editorial/

9 news/

10 exp historical article/

11 Anecdotes as Topic/

12 comment/

13 case report/

14 (letter or comment*).ti.

15 or/7‐14

16 randomized controlled trial/ or random*.ti,ab.

17 15 not 16

18 animals/ not humans/

19 Animals, Laboratory/

20 exp animal experiment/

21 exp animal model/

22 exp Rodentia/

23 (rat or rats or mouse or mice).ti.

24 or/17‐23

25 6 not 24

26 Hearing Aids/

27 "Correction of Hearing Impairment"/is [Instrumentation]

28 (hearing adj (aid* or instrument*)).ti,ab.

29 (ear mold* or earmold* or ear mould* or earmould* or amplif*).ti,ab.

30 or/26‐29

31 (contralateral or bilateral* or binaural or unilateral* or monoaural or (bi adj3 lateral*) or (uni adj3 lateral*) or bimodal).ti,ab.

32 ((both or two or one or left or right or single or double) adj3 (side* or ear or ears or fitting*)).ti,ab.

33 31 or 32

34 30 and 33

35 ((both or two or one or left or right or single or double) adj3 (aid* or instrument*)).ti,ab.

36 34 or 35

37 25 and 36

38 randomized controlled trial.pt.

39 controlled clinical trial.pt.

40 randomi#ed.ti,ab.

41 placebo.ab.

42 randomly.ti,ab.

43 Clinical Trials as topic.sh.

44 trial.ti

45 or/38‐44

46 37 and 45

1 exp *hearing impairment/

2 (hearing adj2 (loss* or impair* or partial* or deficit* or deteriorat* or degenerat* or diminish* or difficult* or disabilit* or hard or one side* or unilateral)).ti,ab.

3 deaf*.ti,ab.

4 (hypoacus* or presbycus* or presbyacus* or sociocus* or nosocus* or anacus*).ti,ab.

5 or/1‐4

6 letter.pt. or letter/

7 note.pt.

8 editorial.pt

9 case report/ or case study/

10 (letter or comment*).ti.

11 or/6‐10

12 randomized controlled trial/ or random*.ti,ab.

13 11 not 12

14 animals/ not humans/

15 nonhuman/

16 exp animal experiment/

17 exp Experimental Animal/

18 animal model/

19 exp Rodent/

20 (rat or rats or mouse or mice).ti.

21 or/13‐20

22 5 not 21

23 Hearing Aid/

24 (hearing adj (aid* or instrument*)).ti,ab.

25 (ear mold* or earmold* or ear mould* or earmould* or amplif*).ti,ab.

26 or/23‐25

27 (contralateral or bilateral* or binaural or unilateral* or monoaural or (bi adj3 lateral*) or (uni adj3 lateral*) or bimodal).ti,ab.

28 ((both or two or one or left or right or single or double) adj3 (side* or ear or ears or fitting*)).ti,ab.

29 27 or 28

30 26 and 29

31 ((both or two or one or left or right or single or double) adj3 (aid* or instrument*)).ti,ab.

32 30 or 31

33 22 and 32

34 random*.ti,ab.

35 factorial*.ti,ab.

36 (crossover* or cross over*).ti,ab.

37 ((doubl* or singl*) adj blind*).ti,ab.

38 (assign* or allocat* or volunteer* or placebo*).ti,ab.

39 crossover procedure/

40 single blind procedure/

41 randomized controlled trial/

42 double blind procedure/

43 or/34‐42

44 33 and 43

#1 [mh "hearing loss"]

#2 (hearing near/2 (loss* or impair* or partial* or deficit* or deteriorat* or degenerat* or diminish* or difficult* or disabilit* or hard or one side* or unilateral)):ti,ab

#3 deaf*:ti,ab

#4 (hypoacus* or presbycus* or presbyacus* or sociocus* or nosocus* or anacus*):ti,ab

#5 [mh ^"persons with hearing impairments"]

#6 {or #1‐#5}

#7 [mh ^"Hearing Aids"]

#8 MeSH descriptor: [Correction of Hearing Impairment] this term only and with qualifier(s): [Instrumentation ‐ IS]

#9 (hearing next (aid* or instrument*)):ti,ab

#10 (ear next mold* or earmold* or ear next mould* or earmould* or amplif*):ti,ab

#11 {or #7‐#10}

#12 (contralateral or bilateral* or binaural or unilateral* or monoaural or (bi near/3 lateral*) or (uni near/3 lateral*) or bimodal):ti,ab

#13 ((both or two or one or left or right or single or double) near/3 (side* or ear or ears or fitting*)):ti,ab

#14 #12 or #13

#15 #11 and #14

#16 ((both or two or one or left or right or single or double) near/3 (aid* or instrument*)):ti,ab

#17 #15 or #16

#18 #6 and #17

Appendix 2. Data extraction form

REF ID:

Study title:

Date of extraction:

Extracted by:

General comments/notes (internal for discussion):

FLOW CHART OF TRIAL:

Group A

(Intervention)

Group B

(Comparison)

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. dropped out

(no available follow‐up data for any outcome)

No. excluded from analysis1 (for all outcomes)

‐ Reason 1

‐ Reason 2

1This should be the people who received the treatment and were therefore not considered ‘dropouts’ but were excluded from all analyses (e.g. because the data could not be interpreted or the outcome was not recorded for some reason)

Information to go into '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, no. of sites etc.

Setting of recruitment and treatment:

Sample size:

  • Number randomised: x in intervention, y in comparison

  • Number completed: x in intervention, y in comparison

Participant (baseline) characteristics:

  • Age:

  • Gender:

  • Main diagnosis: [as stated in paper]

Other important effect modifiers:

  • Hearing loss status:

  • Degree of asymmetry:

Inclusion criteria:
Exclusion criteria:

Interventions

Intervention (n = x): (hearing aid name, type of hearing aid, how this was fitted, hearing aid style, whether volume control is allowed)

Comparator group (n = y):

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

Outcomes1

Outcomes of interest in this review

1. Hearing‐specific health‐related quality of life

  • Hearing Handicap Inventory for the Elderly (HHIE) or HHI for Adults (HHIA)

  • Quantified Denver Scale of Communication (QDS)

  • Auditory Disability Preference – Visual Analogue Scale (ADPI‐VAS)

  • Device Orientated Subjective Outcome Scale

  • Any questionnaire not specified above that is relevant

2. Listening ability

  • Abbreviated Profile of Hearing Aid Benefit (APHAB)

  • Speech, Spatial and Qualities of Hearing (SSQ)

  • Glasgow Hearing Aid Benefit Profile (GHABP) disability subscale

  • Any questionnaire not specified above that is relevant

3. Adverse effects: pain, infection, etc.

4. Patient preference

Secondary outcomes/important outcomes

5. Outcomes reported by carer or 'communication partner' [add information on how this was measured]

6. Usage of hearing aids [add information on how this was measured]

7. Health‐related quality of life (generic scale)

  • Health Utilities Index Mark 3 (HUI‐3)

  • EQ‐5D

  • SF‐36

  • Glasgow Benefit Inventory (GBI)

  • WHO Disability Assessment Schedule (WHO‐DAS)

  • Self‐Evaluation of Life Function (SELF)

  • Any questionnaire mot specified above that is relevant

‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

8. Annoyance scale in patient‐reported outcome measures [add information on how this was measured]

9. Sound localisation as measured by laboratory tests [add information on how this was measured]

10. Speech in noise detection as measured by laboratory tests [add information on how this was measured]

Funding sources

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

Declarations of interest

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

Notes

1DELETE all the outcomes that have not been reported in the study, leaving behind only the outcomes that are reported by the study.

FINDINGS OF STUDY

CONTINUOUS OUTCOMES

Results (continuous data table)

Outcome

Group A ‐ Bilateral

Group B ‐ Unilateral

Other summary stats/Notes

Mean

SD

N

Mean

SD

N

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

Hearing‐specific health‐related quality of life

  • Hearing Handicap Inventory for the Elderly (HHIE) or HHI for Adults (HHIA)

  • Quantified Denver Scale of Communication (QDS)

  • Auditory Disability Preference – Visual Analogue Scale (ADPI‐VAS)

  • Device Orientated Subjective Outcome Scale

Listening ability

  • Abbreviated Profile of Hearing Aid Benefit (APHAB)

  • Speech, Spatial and Qualities of Hearing (SSQ)

  • Glasgow Hearing Aid Benefit Profile (GHABP) disability subscale

Patient preference (add information on how this was recorded)

Usage of hearing aids (add information on how this was recorded)

Health‐related quality of life (generic scale)

  • Health Utilities Index Mark 3 (HUI‐3)

  • EQ‐5D

  • SF‐36

  • Glasgow Benefit Inventory (GBI)

  • WHO Disability Assessment Schedule (WHO‐DAS)

  • Self‐Evaluation of Life Function (SELF)

  • Any questionnaire mot specified above that is relevant

Outcomes reported by carer or 'communication partner'

Sound localisation as measured by laboratory tests

Speech in noise detection as measured by laboratory tests

Comments:

Appendix 3. 'Risk of bias' table template

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High/unclear/low risk

Quote:

Comment:

Allocation concealment (selection bias)

High/unclear/low risk

Quote:

Comment:

Blinding of participants and personnel (performance bias)

High/unclear/low risk

Quote:

Comment:

Blinding of outcome assessment (detection bias)

High/unclear/low risk

Quote:

Comment:

Incomplete outcome data (attrition bias)

High/unclear/low risk

Quote:

Comment:

Selective reporting (reporting bias)

High/unclear/low risk

Quote:

Comment:

Other bias

High/unclear/low risk

Quote:

Comment:

Other bias: insensitive/non‐validated instrument?

High/unclear/low risk

Quote:

Comment: