Carley 1985.
Methods | Design: 5‐week randomised controlled study | |
Participants |
Health condition: elderly people with indolent pressure ulcers Sample size:
Setting, country: Spaulding Rehabilitation Hospital (1 site), Boston, USA Inclusion criteria:
Exclusion criteria: not reported Characteristics of pressure ulcer:
Mean age (SD):
Gender:
§It is not clearly stated whether participants or pressure ulcers were randomised but the number of pressure ulcers equals the number of participants. |
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Interventions |
Total groups in this study: two Experimental: LIDC plus cointervention
Control: conventional wound therapy plus cointervention
Cointervention for both groups
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Outcomes |
Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
Other outcomes not included in this review: (1) "area measurement" (i.e. volume) of the ulcer (expressed as cm3) Time point included in this review: week 5 (end of intervention) Other time points: baseline, week 1, week 2, week 3 and week 4 |
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Notes |
Withdrawals, (n; reason):
Funding source:
Trial registration or published protocol: no information about trial registration or published protocol provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned to LIDC" p443 Comment: insufficient detail reported |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail reported |
Blinding of participants (performance bias) All outcomes | High risk | Quote: "Conventional wound therapy" p443 Comments: not possible to blind participants |
Blinding of personnel (performance bias) All outcomes | High risk | Comments: not possible to blind personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Area measurement of length, width, and depth to within the nearest millimetre were performed by the nursing staff and recorded without previous knowledge" p444 Comment: not clear if assessor was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no dropouts |
Selective reporting (reporting bias) | Low risk | Comment: all pre stated outcomes were reported |
Other bias | Unclear risk | Comment: trial was sponsored by third parties who were likely to have a vested interest in a positive finding |