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Study flow diagram of the number of records identified, included and excluded, and the reasons for exclusions
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Figure 1

Study flow diagram of the number of records identified, included and excluded, and the reasons for exclusions

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Leg Club versus nurse home visits, Outcome 1 Number of people healed.
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Analysis 1.1

Comparison 1 Leg Club versus nurse home visits, Outcome 1 Number of people healed.

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Comparison 1 Leg Club versus nurse home visits, Outcome 2 Quality of life (Spitzer's quality of life index, 0‐10).
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Analysis 1.2

Comparison 1 Leg Club versus nurse home visits, Outcome 2 Quality of life (Spitzer's quality of life index, 0‐10).

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Comparison 1 Leg Club versus nurse home visits, Outcome 3 Pain at 6 months (0 to 100 scale).
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Analysis 1.3

Comparison 1 Leg Club versus nurse home visits, Outcome 3 Pain at 6 months (0 to 100 scale).

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Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 1 Number of people healed.
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Analysis 2.1

Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 1 Number of people healed.

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Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 2 Proportion with recurrence.
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Analysis 2.2

Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 2 Proportion with recurrence.

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Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 3 Proportion fully adherent to compression.
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Analysis 2.3

Comparison 2 Lively Legs programme versus outpatient wound clinic, Outcome 3 Proportion fully adherent to compression.

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Summary of findings for the main comparison. Leg Club compared to nurse home visits

Leg Club compared to nurse home visits

Patient or population: people with venous leg ulcers
Settings: community
Intervention: Leg Club
Comparison: nurse home visits

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Leg Club

Number of people healed
Follow‐up: 6 months

294 per 1000

456 per 1000
(238 to 862)

RR 1.55
(0.81 to 2.93)

67
(1 study)

⊕⊕⊝⊝
low1,2

Not statistically different

Recurrence of ulcers ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Recurrence was probably measured but not reported

Time to healing ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Time to healing was probably measured but was not reported

Adverse events ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Not measured.

Quality of life
Spitzer's quality of life index. Scale from 0‐10.
Follow‐up: 6 months

The mean quality of life score in the control group was 8.11

The mean quality of life score in the intervention groups was
0.85 higher
(0.13 lower to 1.83 higher)

52
(1 study)

⊕⊕⊝⊝
low1,2

Not statistically different

Adherence to compression ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Adherence to compression was not measured

Pain
Medical Outcomes Study Pain Measures. Scale from: 0 to 100.
Follow‐up: 6 months

The mean pain score in the control group was
34.29

The mean pain in the intervention groups was
12.75 lower
(24.79 to 0.71 lower)

60
(1 study)

⊕⊕⊝⊝
low1,2

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

1 Trialists failed to conceal allocation and may have performed an unplanned interim data analysis
2 Low number of participants, some imprecision likely

Figuras y tablas -
Summary of findings for the main comparison. Leg Club compared to nurse home visits
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Summary of findings 2. Lively Legs programme versus outpatient wound clinic

Lively Legs programme versus outpatient wound clinic

Patient or population: people with venous leg ulcers
Settings: community
Intervention: Lively Legs programme

Comparison: outpatient wound clinic

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Lively Legs programme versus outpatient wound clinic

Time to healing ‐ not reported

See comment

See comment

Not estimable

‐

See comment

Data not reported for extraction

Number of people healed
Follow‐up: 18 months

45 per 100

55 per 100
(41 to 74)

RR 1.24
(0.93 to 1.67)

184
(1 study)

⊕⊕⊝⊝
low1,2

Not statistically different

Adverse events ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Adverse events were not reported, unclear if measured

Recurrence of ulcers
Follow‐up: 18 months

57 per 100

47 per 100
(33 to 65)

RR 0.82
(0.59 to 1.14)

136
(1 study)

⊕⊕⊝⊝
low1,2

Not statistically different

Quality of life ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Not measured

Adherence to compression
Follow‐up: 18 months

45 per 100

45 per 100
(31 to 66)

RR 1.02
(0.74 to 1.41)

184
(1 study)

⊕⊕⊝⊝
low1,2

Not statistically different

Pain ‐ not measured

See comment

See comment

Not estimable

‐

See comment

Not measured

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

1 Trialists failed to report randomisation method and allocation concealment
2 Low number of participants and 95% confidence interval includes both no effect and appreciable benefit

Figuras y tablas -
Summary of findings 2. Lively Legs programme versus outpatient wound clinic
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Comparison 1. Leg Club versus nurse home visits

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of people healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 3 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 6 months

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Quality of life (Spitzer's quality of life index, 0‐10) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3 Pain at 6 months (0 to 100 scale) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Leg Club versus nurse home visits
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Comparison 2. Lively Legs programme versus outpatient wound clinic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of people healed Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2 Proportion with recurrence Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3 Proportion fully adherent to compression Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3.1 6 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 12 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 18 months

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. Lively Legs programme versus outpatient wound clinic
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