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Cochrane Database of Systematic Reviews

Intervenciones para ayudar a que los pacientes se adhieran a los tratamientos de compresión para la úlcera venosa de la pierna

Esta versión no es la más reciente

Información

DOI:
https://doi.org/10.1002/14651858.CD008378.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 06 septiembre 2013see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Heridas

Copyright:
  1. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Carolina D Weller

    Correspondencia a: Dept of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia

    [email protected]

  • Rachelle Buchbinder

    Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Malvern, Australia

  • Renea V Johnston

    Monash Department of Clinical Epidemiology at Cabrini Hospital, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Malvern, Australia

Contributions of authors

Carolina Weller: co‐ordinated the review process, conceived the review question, designed and developed the review, completed trial selection, data extraction and analysis, and wrote the first draft of the review. She is guarantor of the work.
Rachelle Buchbinder: supervised the performance of the review and contributed to the development and writing of the review.
Renea Johnston: contributed to the development of the review, completed trial selection, double‐checked data extraction and analysis, and contributed to writing of the review.

Contributions of Wounds Group editorial base

Nicky Cullum: edited the review, advised on methodology, interpretation and review content.
Susan O'Meara: edited the review, advised on methodology, interpretation and review content, and approved the final review prior to submission.
Sally Bell‐Syer: co‐ordinated the editorial process, advised on methodology, interpretation and content, edited the review.
Ruth Foxlee: designed the search strategy, ran the searches and edited the search methods section.

Sources of support

Internal sources

  • Department of Epidemiology & Preventive Medicine, School of Public Health & Preventive Medicine, Monash University, Australia.

    In kind support

  • Cabrini Institute, St Frances Xavier Cabrini Hospital, Australia.

    In kind support

External sources

  • NIHR/Department of Health (England), (Cochrane Wounds Group), UK.

Declarations of interest

Carolina Weller: none known.
Renea Johnston: none known.
Rachelle Buchbinder: none known.

Acknowledgements

The authors would like to thank the peer referees of both the protocol and the review: Wounds Group editors ‐ Mieke Flour, Liz McInnes, Gill Worthy and referees ‐ Una Adderley, Anne‐Marie Bagnall, Salla Seppanen and Janet Yarrow. Thanks also to Elizabeth Royle who copy‐edited the review.    

Version history

Published

Title

Stage

Authors

Version

2016 Mar 02

Interventions for helping people adhere to compression treatments for venous leg ulceration

Review

Carolina D Weller, Rachelle Buchbinder, Renea V Johnston

https://doi.org/10.1002/14651858.CD008378.pub3

2013 Sep 06

Interventions for helping people adhere to compression treatments for venous leg ulceration

Review

Carolina D Weller, Rachelle Buchbinder, Renea V Johnston

https://doi.org/10.1002/14651858.CD008378.pub2

2010 Feb 17

Interventions for helping people adhere to compression treatments for venous leg ulceration

Protocol

Carolina Weller, Rachelle Buchbinder, Renea V Johnston

https://doi.org/10.1002/14651858.CD008378

Differences between protocol and review

Planned meta‐analyses, subgroup and sensitivity analyses could not be performed, as we included only two trials with different interventions in the review.
Adherence to compression was a planned secondary outcome in the protocol, but we changed this to a primary outcome to reflect the review objectives better.
We reported in the protocol that we would contact relevant companies, but, as the intervention did not include compression or other devices, this was not necessary.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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
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
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