Dowling 2007/Dowling 2005.
| Methods | Note: The Dowling 2005 and Dowling 2007 articles report on the same trial. Dowling 2005 reports on the effect of light therapy on reducing rest‐activity disruption, Dowling 2007 reports on the outcome of the effect of bright light therapy on disruptive behaviours. Participants randomly assigned to one of three groups: 1) morning bright light (n=29), 2) afternoon bright light (n=24), or 3) usual indoor light (control) (n=17) Total = 70 Single‐blind |
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| Participants | Country: USA 70 nursing home residents (57 women, 13 men), mean age 84 (SD 10) ranging from 58 to 98, MMSE 0‐23 (mean=7, SD 7) |
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| Interventions | Bright light exposure >2500 lux: Group 1: morning (9:30‐10:30am), Group 2: afternoon (3:30‐4:30pm) or supplemented using Apollo Brite Lite IV box placed at least 4 feet from resident Frequency: Daily, Monday through Friday Duration: 10 weeks Group 3: The control group received usual indoor light (150‐200 lux) and participated in their regular activities |
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| Outcomes | Dowling 2005: Sleep efficiency, sleep duration, night time activity, nighttime awakenings Dowling 2007: Psychiatric disturbances, agitation, depression using the NPI‐NH scroes after 10 weeks of treatment |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | All participants who met inclusion criteria and who agreed to participate (correspondence from Dowling April 14.2013) |
| Allocation concealment (selection bias) | Low risk | Participants were randomly assigned using a permutated blocking procedure in which the number of participants allocated to each group was forced to be equal after an a priori defined “balancing” number of participants were enrolled in the study (correspondence from Dowling October 28, 2008) Participants were randomized by a computer generated program to the groups (correspondence from Dowling April 14 2013 |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Nursing staff were potentially aware of participants’ study group assignment (Dowling 2007, p966; April 14, 2013 confirmed) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes assessors were potentially aware of study group assignment (correspondence from Dowling April 14, 2013) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition rates and reasons for attrition for the two groups not specifically described but it was reported that there were no significant differences between groups. Reasons for drop out no longer available (correspondence from Dowling April 14, 2013) |
| Selective reporting (reporting bias) | Low risk | Both articles reported on outcomes identified in their objectives |
| Other bias | Low risk | Compliance with wearing the Actiwatch was 84% with no significant differences between the groups. The mean percentage of bright light therapy received was 76% (SD=17, range 28–100) and there was no significant difference in dose between the groups |