Lundberg 2011.
| Methods | Randomised Data collection 2007 to 2008 |
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| Participants | N = 69 final numbers but there is some discrepancy in the way this was reached depending on where you read in the text Inclusion criteria: 60 to 75 years of age, mild‐moderate HL, to have had HA fitted at least 1 year prior to study, to have HHIE score of > 20 (indicative of residual handicap) |
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| Interventions | Intervention group received a booklet with weekly topic‐based reading instructions based on chapters of the book plus 5 x 10‐ to 15‐minute telephone calls with an audiologist to discuss the content of the book Control group received the booklet but no instructions or telephone follow‐up |
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| Outcomes | Short‐term: HHIE (HANDICAP), HADS (PSYCHOLOGICAL IMPACT), IOI‐HA (inc USE) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised" Comment: probably done but no details of exact randomisation procedure given |
| Allocation concealment (selection bias) | Unclear risk | Randomisation was carried out by someone independent of the study data collection but not clear whether concealed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants not blinded due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: authors do comment that blinding the questionnaire administrators may have improved quality of the study. They recognised the potential bias |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | They did explain how many dropped out and gave reasons and those included under ITT where included on a LOCF basis 1 participant in the control group was deemed an outlier and was thereby excluded from analyses because the participant's data differed by more than 2 SD from the control group mean measured before and after the intervention. Unclear whether this is appropriate |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | Authors give a good discussion of other potential sources of bias |