Bragard 2013.
Methods | Randomised controlled trial with cross‐over design and individual allocation. Comparison: individually applied blue‐enriched light vs no treatment. Participants allocated into 2 blocks: ABAB and BABA, where 2 × 4‐week periods of using intervention A were alternated with 2 × 4‐week periods of not using (intervention B). |
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Participants | Staff members (secretaries, nurses, doctors, psychologists, physicians) working in a hospital with no access to natural light; n = 25. Only 25% of the staff participated in the study. Mean (SD) age 36.6 ± 7.7 years. | |
Interventions | Intervention A: blue‐enriched light emitted by 8 LEDs mounted in spectacles (Luminette), which were directed on the lower part of the retina. Participants used Luminette at work between 07:00 a.m. and 09:00 a.m. for a maximum of 30 minutes a day, at least 5 days a week. Intervention B: no treatment. |
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Outcomes | Alertness assessed using Epworth Sleepiness Scale. Mood assessed and reported using Beck Depression Inventory‐II. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomisation performed by random draw. |
Allocation concealment (selection bias) | Unclear risk | Comment: methods for allocation concealment not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: intervention compared to no treatment. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcomes derived from questionnaires answered by participants not blind for interventions. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Fourteen employees participated in all assessment phases. No significant scoring difference was noted at time in the questionnaires between subjects who continued (n = 14) and those who stopped (n = 11). Reasons for stopping the use of Luminette® were multiple: negative side effects (e.g. migraines, nausea), decreased interest in the study, exclusion of pregnant women, and holidays (including Christmas)." Comment: only 14/25 participants finished study protocol. Reasons not fully reported. High rate of attrition (44%). Unclear if there was imbalance between groups regarding number of losses and reasons for dropping out. |
Selective reporting (reporting bias) | High risk | Comment: data from SIGH‐HDRS, planned in Methods section, was not reported. |
Other bias | Low risk | Comment: no other bias identified. |
Carry‐over effect | Unclear risk | Comment: carry‐over effect could not be ruled out. |
Availability of 2‐period data | Low risk | Comment: data reported from first and second intervention period and for first control period. |
Incorrect analysis | Low risk | Comment: paired analyses presented. |
Comparability of results with those from parallel‐group trials | Unclear risk | Comment: no results from parallel‐group trials available for same intervention. |