Thoren 2011.
| Methods | Randomised | |
| Participants | N = 59 (intervention group 29, control 30) recruited through adverts in newspapers and referred to a website Age: range 24 to 84, mean 63.5 29 women and 30 men; majority (67%) had education equivalent to university level Inclusion criteria: experienced HA users, hearing impairment with subjective significant communication difficulties (defined as over 20 on HHIE), using HA for at least 1 year, 18 years plus, Swedish as first language, access to PC and internet Exclusion criteria: not able to have a conversation by telephone, severe tinnitus, Ménière's |
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| Interventions | Intervention: online education programme including professional guidance (5‐week programme including information, tasks, assignments and professional contact) Control: online discussion forum with weekly topics but no professional guidance |
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| Outcomes | Short‐term: immediately post‐intervention ‐ questionnaires administered online HHIE, IOI‐HA, SADL, HADS Medium‐term: 6 months ‐ as above |
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| Notes | This was a well‐designed study with a good attempt made to include a placebo intervention References CONSORT guidelines |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "...randomly assigned by an independent researcher" Comment: almost certainly done |
| Allocation concealment (selection bias) | Low risk | Allocation undertaken by researcher independent of the study |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: probably was blinded to the participants – they were all given the same instructions pre‐study and both intervention and control group involved the internet However, blinding not explicitly stated but implied |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessment was online |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Results analysed on ITT LOCF – very clearly explained. Reasons for dropouts given |
| Selective reporting (reporting bias) | Unclear risk | As far as one can tell but no protocol available |
| Other bias | Low risk | This study appears to be free of other sources of bias. Limitations discussed. No 'no treatment' control but the placebo control group was well thought out |