Peterson 2003.
Methods | Method of allocation: Each magnifying device was presented in a random order to participants; theywere asked to complete (also in a randomorder) a series of 4 tests chosen specifically to replicate daily living tasks. Methods of randomisation are not described. Masking: Participant -masking issues are not described but the study should be unmasked given the use of recognisable devices. Provider - same as above; Outcome - same as above Exclusions after randomisation: none reported. Losses to follow-up: none reported. Unusual study design: Within-subject design, i.e. a cross-over study in which all participants try the devices consecutively |
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Participants | Country: UK Number randomised: 70 Age, Sex: 35 men with mean age: 68.3 (SD: 22.8) years and 35 women with mean age: 71.8 (SD: 20.6) years. Inclusion criteria: consecutive visually impaired participants. Each had previously undergone ophthalmologic care and a full low-vision examination including optimization of their refraction and their optical magnifier. Minimum magnification for comfortable reading of the participants' chosen print size was prescribed. Exclusion criteria: none. |
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Interventions | Treatment: various electronic vision enhancement systems (EVES) vs the subject's optimum conventional optical magnifier for near task. Optical magnifiers were a hand magnifier (n. 24), a stand magnifier (n. 45), and high-powered reading glasses (n. 1) with an average nominal magnification (lens dioptric power divided by 4) of 5.7 times (range, 2.0 - 14.7 times). EVES were:
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Outcomes | After an explanation, demonstration and a 2-minute active training period with each magnifying device the participants were asked to complete a series of 4 tests chosen to replicate daily living tasks:
4 versions of each task, equal in difficulty (in terms of number, length, and difficulty of words and page distance), were constructed and used in a randomised order to control fatigue effects |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised presentation of devices; although no further detail was given on how the randomisation sequence was generated, selection bias should be avoided since all participants used all devices (crossover study design) |
Allocation concealment (selection bias) | Low risk | Randomised presentation of devices; although no further detail was given on how randomisation sequence was concealed, selection bias was likely to be avoided since all participants used all devices (cross-over study design) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not all participants could read using all devices; thus, the analysis is not intention-to-treat |
Selective reporting (reporting bias) | Low risk | No protocol available, but primary outcome reported |
Period effect | Unclear risk | No details reported |
Carry-over effect and period-by-treatment interaction | Unclear risk | Authors reported they used reading and real-word tests of very short duration, but no quantitative details are available |
Other bias | Low risk | No other bias identified |