| Study characteristics |
| Methods |
Study objective: to compare the cost effectiveness of 4‐layer bandaging with that of alternative dressings available for venous leg ulcers in a pragmatic randomised clinical trial
Trial design (e.g. parallel group) including research sites: parallel
Follow‐up period: 12 weeks
Number of arms: 2
Study start date and end date: recruitment from April 1999 to August 2000
Care setting: community |
| Participants |
Study population: people with a venous leg ulcer
Eligibilitycriteria: those with a venous leg ulcer who were not being treated with 4‐layer bandaging; venous ulcers defined with clinical evidence of venous disease, the resting ABPI = 0.9 or greater, and no other cause identified
Sex (M:F): 35:65 in 4LB; 33:67 in control
Age (years): mean 71.7 (SD 9.8) in 4LB; 71.4 (11.5) in control
Duration of leg ulcers: median 9 (IQR 4 to 27) weeks in 4LB; 11 (5 to 28) in control
Baseline leg ulcer area: median 3.5 (IQR 1.3 to 8.1) cm2 in 4LB; 2.7 (1.6 to 6.2) in control
Group difference: no difference
Total number of participants: 200
Unit of analysis (including number of ulcers per person): participant
Unit of randomisation (e.g. leg ulcer, limb, or participant): participant |
| Interventions |
Intervention characteristics
Four‐layer bandaging
Details of interventions (including compression devices used, and duration of interventions applied): comprising a sterile wound contact layer, a natural padding bandage, a light conformable bandage, a light compression bandage and a flexible cohesive bandage. This combined system provided sustained external compression of 40 mmHg at the ankle Descriptions of any co‐interventions or standard care: not described Number of participants randomised: n = 100 participants Number of participants analysed: n = 100 participants
Usual care (alternative dressings)
Details of interventions (including compression devices used, and duration of interventions applied): including an assortment of topical dressings, such as hydrocolloids, alginates, paraffin and iodine dressings. Absorbency dressings, low‐pressure bandages and elasticated support also used (5 participants had compression applied at some stage during the 3‐month study interval) Descriptions of any co‐interventions or standard care: not described Number of participants randomised: n = 100 participants Number of participants analysed: n = 100
|
| Outcomes |
Time‐to‐complete wound healing
Outcome type: time‐to‐event Time points: 12 weeks Reporting: partially reported Measurement method (e.g. scale, self‐reporting): photographs taken; not described who assessed the outcome (probably nurses) Definition: time to heal the leg ulcer; healing = full epithelialisation and no scab present; among those with bilateral leg ulcers, the leg with the larger surface area of ulceration considered Missing data and reasons (including the number of people who died): 1 died and 2 lost to follow‐up in 4LB and 0 died or lost in control; ITT analysis performed
Proportion of wounds completely healed during follow‐up
Outcome type: binary Time points: 12 weeks Reporting: partially reported Measurement method (e.g. scale, self‐reporting): see above Definition: see above Missing data and reasons (including the number of people who died): see above Notes: adjusted healing rates (age, baseline ulcer area and duration, and history of DVT, rheumatoid arthritis and diabetes) reported but not extracted for this review.
Adverse events
Outcome type: binary Time points: 12 weeks Data and results(including summary results, or any data that will allow its calculation): 1 died in 4LB but information not reported in control group. Notes: this outcome is unlikely measured using a prespecified method.
Participant health‐related quality of life/health status
Outcome type: continuous Time points: 6 weeks Reporting: partially reported Measurement method (e.g. scale self‐reporting): participants interviewed and disease‐specific quality‐of‐life instrument for chronic lower limb venous insufficiency (CIVIO) used, as well as the SF‐36 generic questionnaire. CIVIO is a 20‐item, and 4‐domain (psychosocial, physical functioning, social functioning and pain) questionnaire designed for chronic venous disease (lower score = better quality of life). SF‐36 with a score from 0 to 100 (higher score = better health) Definition: health‐related quality of life Missing data and reasons (including the number of people who died): questionnaires completed for 92.9% (79/85) and 95.8% (91/95) patients who remained unhealed at 6 weeks in 4LB and control groups (the rest of participants did not complete questionnaires because of their healing)
Cost effectiveness
Time points: 12 weeks Definition: median cost per leg healed (for cost‐effectiveness analysis); and cost per patient (for cost analysis). Cost valued in Euros; and considered these resources: dressing products, nurses’ time, mileage expenses, and GP and hospital services Missing data and reasons (including the number of people who died): 2 missed in 4LB but reasons not specified Note:cost analysis: median (IQR) EUR 209.7 (137.5 – 269.4) in 98 participants; EUR 234.6 (168.2 – 345.1) in 100 participants; cost‐effectiveness analysis : median cost per leg healed significantly less for 4‐layer bandage treatment (P = 0·040)
Mean pain score
Outcome type: continuous Time points: 6 weeks Reporting: partially reported Measurement method (e.g. scale, self‐reporting): participants interviewed and disease‐specific quality‐of‐life instrument for chronic lower limb venous insufficiency (CIVIO) used. CIVIO has the domain of pain (lower overall score = better quality of life) Definition: pain measured in CIVIO Missing data and reasons (including the number of people who died): questionnaires completed for 92.9% (79/85) and 95.8% (91/95) participants who remained unhealed at 6 weeks in 4LB and control groups (missing data for the rest of participants because of their unhealing) Notes: 12‐week data not collected.
Outcomes that are not considered in this review but reported in trials:
|
| Identification |
Publication type/ status (e.g. conference abstract): full papers (see O'Brien 2003)
Trial protocol: not available
Source of funding: Smith & Nephew Ltd provided an educational grant to fund this study
Country of origin: Ireland
Comments: the authors presented the cost per leg ulcer healed for economic analysis in which the benefit was measured as leg ulcer healed
Contact information: Mr P. E. Burke, Department of Vascular Surgery, St John’s Hospital, Limerick, Ireland (e‐mail: vsherlock@mwhb.ie). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: “… a random ‘intervention’ or ‘control’ list was generated for 200 patients by computer …”
Comment: low risk of bias because of the use of a proper randomisation method |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: “Before the study began, a random ‘intervention’ or ‘control’ list was generated for 200 patients by computer, and the results were entered sequentially into sealed numbered envelopes. These envelopes were assigned to consecutive patients once consent had been obtained”
Comment: unclear risk of bias because they do not describe if envelopes are opaque |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: no information provided |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome group: ulcer healing
Quote: “The ulcerated area was measured and photographed by the research officer”
Quote: “a photograph of the site was taken to provide an objective review of outcome”
Comment: low risk of bias because attempts are made to reduce the risk of detection bias
Outcome group: cost
Comment: no information provided |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Outcome group: ulcer healing and cost analysis
Quote: “Intention‐to‐treat analysis was carried out”
Quote: “Data missing for two patients” in Table 3 of O'Brien 2003 (for cost).
Comment: low risk of bias because of ITT analysis performed and very low rate of missing data (2 of 100 in 4LB) for cost analysis
Outcome group: quality of life
Comment: unclear risk of bias because the rates of missing data are 15% in 4LB and 5% in control. The missing is due to ulcer healing among them and questionnaires only completed for those with unhealed ulcers at 6 weeks (92.9%, 79/85 in 4LB; and 95.8%, 91/95 in control) |
| Selective reporting (reporting bias) |
Low risk |
Comment: the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified |
| Other bias |
Low risk |
Comment: the study appears to be free of other sources of bias |
