| Methods |
Method of allocation: Assignment stratified by level of functioning. First participant assigned by flipping a coin, the following by alternation.
Masking: Participant ‐ not used in this review; Provider ‐ not used in this review. Outcome: Pre‐testing could be masked because it was performed before randomisation; post‐testing not masked because performed by the same volunteer who delivered the intervention.
Losses to follow‐up: 13; mostly due to illness. |
| Participants |
Country: USA
Number randomised: 43
Age: 60+ (mean 76)
Sex: 22 F, 13 M among 35 who completed the program.
Inclusion criteria: Age 60+, legally blind, have indoor O&M needs, have some degree of independent mobility, have sufficient cognitive functioning to comprehend verbal communication, be willing to participate.
Participant characteristics: 19 did not have balance problems and did not use devices such as canes; 4 had some balance problems; 8 used a cane and 4 needed a wheelchair. Visual impairment from 9 years average, mainly due to glaucoma. 37% were totally blind and 40% had light perception only. 9 participants had some cognitive impairment. |
| Interventions |
The intervention consisted of a series of scripted lessons to be administered by a volunteer. The O&M instruction programme was personalised according to the level of physical functioning of the participant, specifically according to the type of device used. The volunteer received both written and oral instruction that enabled her/him to perform with the participant simple indoor O&M techniques during one hour of orientation to the project. The fields of instruction corresponded to the activities described in the Outcomes section. The volunteer‐participant pairs worked on the program for 90 minutes a week for 10 to 12 weeks. |
| Outcomes |
Assessment instrument delivered by the volunteer and consisting of Pfeiffer Short Portable Mental Status Questionnaire, an Orientation scales, a Mobility scales; some scales may not have been delivered if inappropriate for certain participants. The Orientation and Mobility scales provided the outcome measures. Two versions of the instrument (for people using or not using a device, such as cane, walker or wheelchair).
Outcome measures: percent of correct behaviours performed out of those possible for that participants (not all activities could be performed by all participants). Scores of 24 skills were summed‐up for 3 subscales (orientation, sight guided, independent). A total score could be compared. |
| Notes |
The authors provide a discussion of several issues in the instrument development:
‐ the delivery of assessment and training by inexperienced healthy volunteers, including
‐ the absence of criteria to determine the acquisition of a skill
‐ having tested participants in their own environment, where they had already gained independence in most cases
‐ ceiling effect in some tasks, such as the seating skills |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
High risk |
First participant assigned flipping a coin, then by alternation. |
| Allocation concealment? |
High risk |
Alternation was used, which allows investigators to foresee treatment assignment. |
| Blinding?
All outcomes |
High risk |
Masking patients and care providers is impossible in this field of research; outcome assessors were masked at baseline but not during follow‐up. The latter type of masking can also be impossible to achieve if participants randomised to O&M training use a cane as a part of the intervention. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
35 out of 43 people completed follow‐up, but the loss in each assignment arm is not reported. |
| Free of selective reporting? |
Low risk |
Subscales of a questionnaire are the primary outcome. |
| Free of other bias? |
Low risk |
No other sources of bias are identified. |
