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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).
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Analysis 1.1

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 1 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).
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Analysis 1.2

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 2 Amputation Rate (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).
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Analysis 1.3

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 3 Foot ulcer incidence (1‐year follow‐up).

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).
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Analysis 1.4

Comparison 1 Effects of intensive versus brief education in high risk patient samples, Outcome 4 Amputation rate (1‐year follow‐up).

Table 1. Results from trials

Study ID

Primary outcomes

Secondary outcomes

Barth 1991

No primary outcomes reported

Foot problems requiring treatment:
Significant reduction in intervention after 1 month (P < 0.001), maintained until final follow‐up at 6 months
Reduction was significantly smaller in control than in intervention after 1 month (P < 0.006), but not after 6 months (P = 0.216)

Foot care knowledge:
Significant increase in both groups at 1 month (P < 0.001), but more in intervention than in control (P < 0.001). Changes were maintained until final follow‐up at 6 months

Foot care routine compliance:
Significant increase in intervention after 1 month (P < 0.001), maintained until final follow‐up
Increase was significantly greater in intervention than in control after 1 month (P = 0.012)

Bloomgarden 1987

Ulcer or amputation:
people with no foot lesions at baseline:
intervention 2/83 vs control 2/63

people with callus, nail dystrophy or fungal infection at baseline: intervention 2/37 vs control 3/63

people with an ulcer or amputation at baseline: intervention 6/7 vs control 11/13

Callus, nail dystrophy and fungal infection:
people with no foot lesions at baseline: intervention 31/83 vs control 28/63 (ns)
people with callus, nail dystrophy or fungal infection at baseline: intervention 24/37 vs control 46/63 (ns)
people with an ulcer or amputation at baseline: intervention 1/7 vs control 1/13 (ns)

Behaviour assessment scores:
intervention from 3.4 to 4.3. Control from 3.6 to 4.1 (P = 0.10). Separate data for foot care not provided

Borges 2004

No primary outcomes reported

Patients' self‐reported behaviour assessment scores:
intervention from 4.7 to 5.6 (P < 0.01). RA from 4.8 to 5.2 (P = 0.06). C from 5.1 to 5.4 (P < 0.05)

Observed self‐care behaviour:
4 of 16 items significantly (P < 0.05) more observed in intervention than in control

Foot care knowledge scores:
Increased within the control group, but not in the intervention or RA groups

Cisneros 2010

Ulcer incidence:

people without a history of foot ulceration: intervention 8/21 vs control 8/14 (P = 0.317)

Patient with a history of foot ulceration: intervention 1/8 vs control 5/8 (P = 0.119)

All people: difference between the survival curves of intervention and control (P = 0.362) (HR not reported)

No secondary outcomes reported

Corbett 2003

No primary outcomes reported

Foot care knowledge scores:
intervention from 4.9 to 6.1 vs control from 4.6 to 5.2 (P = 0.03)

Foot care practice scores:
intervention from 4.3 to 5.6 vs control from 4.1 to 4.3 (P = 0.007)

Frank 2003

No primary outcomes reported

Foot care knowledge scores:
Means: intervention 20.98 (SD 2.46) vs control 18.60 (SD 2.93), (P < 0.001)
Mean differences: intervention 2.33 (SD 2.49) vs control 1.10 (SD 2.89), (P = 0.028)

Patients' behaviour assessment:
(mean number of days per week)
Checking feet: intervention 6.33 vs control 5.88 (P = 0.203). Mean differences: intervention 1.13 vs control 1.35 (P = 0.708)
Washing feet: intervention 5.75 vs control 5.94 (P = 0.573). Mean differences: intervention 0.58 vs control 0.52 (P = 0.863)
Applying lotion: intervention 5.96 vs control 4.94 (P = 0.044). Mean differences: intervention 1.42 vs control 0.75 (,P = 0.191)
Wearing shoes and socks: intervention 5.60 vs control 5.42 (P = 0.705). Mean differences: intervention 1.90 vs control 0.50 (P = 0.036)

Kruger 1992

No primary outcomes reported

Foot status:
No significant difference.

Foot care knowledge scores:
intervention from 9.1 to 10.0 vs control from 8.66 to 9.86, statistically significant increase in control group (P = 0.02), but not in the intervention group (P = 0.078)

Behaviour assessment:
Daily foot inspection: intervention from 52.5% to 66.7% vs control from 34.8% to 66.7% (ns)
Daily foot washing: intervention from 82.6% to 86.7% vs control from 74.1% to 73.3% (statistically significant increase in intervention group)
Use of pumice stones for corns: intervention from 4.3% to 26.7% vs control from 3.7% to 26.7% (ns)
Trimming toenails regularly: intervention from 34.8% to 80.0% vs control from 66.7% to 66.7% (statistically significant increase in intervention group)
Improvement in keeping toenails shorter: intervention from 30.4% to 80.0% vs control from 66.7% to 86.7% (ns)

Lincoln 2008

Ulcer incidence:
After 6 months: intervention 26 vs control 18, RR 1.41 (95% CI 0.84 to 2.38)
After 12 months: intervention 36 vs control 35, RR 1.00 (95% CI 0.70 to 1.44)

Amputation rate:
After 6 months: intervention 3 vs control 0, RR not estimable
After 12 months: intervention 9 vs control 9, RR 0.98 (95% CI 0.41 to 2.34)

Behaviour assessment scores:
intervention 42.0 vs control 38.7 (P = 0.03)

Malone 1989

Ulcer incidence:
intervention 8 vs control 26; significantly lower in intervention group (P ≤ 0.005)

Amputation rate:
intervention 7 vs control 21; significantly lower in intervention group (P < 0.025)

No secondary outcomes reported

Mazzuca 1986

No primary outcomes reported

Foot care knowledge scores:
No significant difference

Rettig 1986

No primary outcomes reported

Foot appearance scores (mean ±standard error):
intervention 70.2 ± 0.7 vs control 68.8 ±0.7 (ns)

Foot care knowledge scores:
intervention 62.2 ±1.7 vs control 53.1 ± 1.8 (P = 0.001). Significant increase in intervention group

Foot care skills scores:
intervention 71.8 ±2.0 vs control 68.9 ± 1.8 (ns)

Rönnemaa 1997

Amputation:
1‐year follow‐up: intervention 0 vs control 0

7‐year follow‐up: intervention 1 vs control 0

Foot ulceration:
1‐year follow‐up: intervention 1 vs control 0

7‐year follow‐up: intervention 1 vs control 1

Callus development:
1‐year follow‐up:

Calcaneal region:

  • presence of callus: intervention from 18.5% to 12.0% vs control from 16.8% to 15.5% (ns)

  • mean diameter: intervention from 40.5 mm (SD 30.8 mm) to 25.5 mm (SD 28.8 mm) vs control from 30.6 mm (SD 28.5 mm) to 28.3 mm (SD 26.8 mm); statistically significant decrease in area of callosities at calcaneal region in intervention group (P = 0.065)

Other regions:

  • presence of callus: intervention from 54.5% to 39.5% vs control from 51.3% to 48.2%; significant decrease in callosities in intervention group (P < 0.009)

  • mean diameter: intervention from 16.6 mm (SD 10.2 mm) to 11.4 mm (SD 10.3 mm) vs control from 15.2 mm (SD 9.8 mm) to 14.4 mm (SD 9.9 mm); statistically significant decrease in area of callosities in intervention group (P < 0.001)

7‐year follow‐up:

Calcaneal region:

  • presence of callus: intervention 12.4% vs control 12.9%, RR 0.96 (95% CI 0.55 to 1.70)

Other regions:

  • presence of callus: intervention 23.1% vs control 30.1%, RR 0.77 (95% CI 0.53 to 1.01)

Foot care knowledge scores:
1‐year follow‐up:

  • intervention from 26.7 (SD 11.4) to 32.1 (SD 10.8) vs control from 26.1 (SD 11.8) to 29.2 (SD 12.6); statistically significant increase in intervention group (P = 0.004)

7‐year follow‐up:

  • mean scores: intervention 33.6 (SD 10.5) vs control 33.0 (SD 11.1) (ns)

Patients' behaviour assessment scores:
1‐year follow‐up:

  • mean scores: intervention from 5.4 (SD 2.8) to 7.0 (SD 3.2) vs control 5.3 (SD 2.6) to 6.0 (SD 2.5); statistically significant increase in intervention group

7‐year follow‐up:

  • mean scores: intervention 6.6 (SD 2.7) vs control 6.4 (SD 2.7) (ns)

Abbreviations: CI = confidence interval, ns = no statistical significance, RA = group that received risk assessment only, RR = risk ratio, SD = standard deviation.

Figuras y tablas -
Table 1. Results from trials
Comparison 1. Effects of intensive versus brief education in high risk patient samples

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.14, 0.66]

2 Amputation Rate (1‐year follow‐up) Show forest plot

1

354

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.15, 0.76]

3 Foot ulcer incidence (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.70, 1.44]

4 Amputation rate (1‐year follow‐up) Show forest plot

1

172

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.41, 2.34]

Figuras y tablas -
Comparison 1. Effects of intensive versus brief education in high risk patient samples