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Cochrane Database of Systematic Reviews

Interventions for actinic keratoses

Información

DOI:
https://doi.org/10.1002/14651858.CD004415.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 12 diciembre 2012see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Piel

Copyright:
  1. Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Aditya K Gupta

    Correspondencia a: Faculty of Medicine, University of Toronto, Toronto, Canada

    [email protected]

    Mediprobe Research Inc., London, Canada

  • Maryse Paquet

    Mediprobe Research Inc., London, Canada

  • Elmer Villanueva

    Department of Public Health, Xi'an Jiaotong‐Liverpool University, Suzhou, China

  • William Brintnell

    Mediprobe Research Inc., London, Canada

Contributions of authors

We indicate below the contributions made by the reviewers.

  • Link with editorial base and coordinate contributions from co‐reviewers (AG)

  • Draft protocol (AG, RW, with contributions from all)

  • Run search (AG, WB, and MP)

  • Identify relevant titles and abstracts from searches, i.e. broad screen (MP and WB)

  • Obtain full text copies of studies (WB and MP)

  • Select trials to include (WB, MP, and AG as arbitrator when necessary)

  • Extract data from trials (WB and MP)

  • Enter data into RevMan (MP)

  • Carry out the analysis (MP and EV)

  • Interpret the analysis (MP)

  • Draft final review (MP, WB, and AG)

  • Update the review (MP)

Declarations of interest

Dr Aditya Gupta, lead author of this review, participated in a clinical trial sponsored by DUSA in 2004, which was excluded from the review because it did not meet the inclusion criteria.

Dr Stephen Keohane, clinical referee for this review, states: "I have been paid for lectures and advisory boards by Galderma, Almirall, Intendis, Inc., Shire, and Bayer."

Acknowledgements

The Cochrane Skin Group editorial base wishes to thank Dedee Murrell who was the Key Editor for this review; Jo Leonardi‐Bee and Philippa Middleton who were the Statistical and Methods Editors, respectively; the clinical referees, Hywel Williams and Stephen Keohane; and the consumer referee, Jack Tweed.

The following people contributed to earlier versions of this review; the authors would like to acknowledge their contribution: Kimberley Inniss, Robert Wainwright, Melody Chow, Elizabeth Cooper, Kristy Johnson, and Zbys Fedorowicz. The authors would also like to thank Chris Drummond‐Main and Fiona C. Simpson for their input.

Version history

Published

Title

Stage

Authors

Version

2012 Dec 12

Interventions for actinic keratoses

Review

Aditya K Gupta, Maryse Paquet, Elmer Villanueva, William Brintnell

https://doi.org/10.1002/14651858.CD004415.pub2

2003 Oct 20

Interventions for actinic keratoses

Protocol

Aditya K Gupta, Kimberley Inniss, Robert Wainwright, Melody Chow, Elizabeth Cooper

https://doi.org/10.1002/14651858.CD004415

Differences between protocol and review

Authorship: Since the publication of the Cochrane Protocol in 2009, the review has been updated by new authors.

Background: This was updated as the protocol was published in 2003. The 'Disease definition' section was modified to emphasise the relationship between actinic keratosis and squamous cell carcinoma, and previous information about the differential diagnosis was moved to the 'Clinical features' section. The 'Epidemiology and causes' section title was changed to 'Pathogenesis and epidemiology' to reflect better the order of the information presented. Finally, a 'How the intervention might work' section was added to follow the recommendation in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Methods:

Criteria for considering studies for this review:  

Types of interventions: The sentence on the comparators accepted was slightly modified to include any variation of the treatment (duration, concentration, etc) because several studies investigated the influences of these parameters on primary and secondary outcomes.

Types of outcome measures: The rationale for selecting only per participant outcomes (i.e. randomisation per participant and not per lesion) was presented, as well as a description on the general method used to evaluate efficacy in the included studies.

Changes in the primary outcomes:

a) To make a distinction between "Global degree of improvement in symptoms and/or signs as rated by participant or medical practitioner" (subjective) and "Participant complete clearance" (objective), subjective assessment was added before the outcome description. Only global improvement indices for completely improved or cleared were considered for inclusion in meta‐analysis.

b) "Lesion clearance rate of 100% and 75%" were changed for "participant complete (100%) or partial (> 75%) clearance" to make a distinction between "lesion complete response" expressed per lesion, which is not included in our review, and the number of participants with the percentage of lesions cleared. "Participant complete clearance" and "Participant partial (> 75%) clearance" were presented separately.

c) The outcomes reported in actinic keratoses studies that could be reported as "Improvement in quality of life" were cosmetic outcomes, which were reported separately as secondary outcomes. Thus, 'Improvement in quality of life' was removed from our primary outcomes.

The objective assessment, "Mean reduction in lesion counts" expressed as absolute values or percentages was included in the review because this per participant outcome was often reported, and it was the only efficacy outcome that could be analysed by meta‐analysis for intraindividual studies. Thus, all primary outcomes became efficacy outcomes.

Changes in the secondary outcomes:

(a) "Severe adverse events, i.e. severe enough to require withdrawal of treatment" was changed to "Withdrawal due to adverse events" to avoid problems with the interpretation of data.

(c) "Minor patient‐reported adverse events, not sufficient to require cessation of treatment, excluding skin irritation" was replaced by "Minor adverse events excluding skin irritation" because the source, reported by participant or investigator, was generally not specified.

To fulfil the requirement of a 'per participant' outcome for meta‐analysis, all safety outcomes were the number of participants experiencing events in general or a specific event, and cosmetic outcomes were the number of participants with the different cosmetic measurement.

Search methods for identification of studies:

Electronic searches: We updated all searches in March 2011, and the LILACs database was added, as well as different online ongoing trial registers.

Unpublished literature: We searched additional companies, as well as the FDA website, for clinical trials in the product insert.

Conference proceedings: We searched conference proceedings from additional associations.

Data collection and analysis:

Selection of studies/Data extraction and management:

Several collaborators contributed to this review over the years, and they shared different responsibilities in the study selection, data extraction, and data analysis. During a global revision of the manuscript undertaken in March 2011, the different roles were redistributed to the current authors, and they may differ from the protocol.

Assessment of risk of bias in included studies:

Cochrane methodology was changed for assessment of methodological quality. Thus, the quality of the data was assessed with two new tools: 1) the 'Risk of bias' tables included in RevMan 5.1, and 2) the quality of evidence by the GRADEpro software.

Analysis:

The section of the protocol on planed data analysis has been divided into the following sections: measures of treatment effect, unit of analysis issues, assessment of heterogeneity, data synthesis, and subgroup analysis and investigation of heterogeneity.

In 'Measures of treatment effect', the original protocol stated that the results will be expressed as odds ratios for dichotomous outcomes. However, the results were presented as risk ratios because they are easier to interpret.

In 'Unit of analysis issues', a strategy for analysis and reporting of data from intraindividual studies and studies with multiple treatments was added.

In 'Assessment of heterogeneity', a cut‐off value of the I² statistic as a measure of heterogeneity was added.

In 'Data synthesis', no meta‐analysis method was specified in the protocol, but a random‐effects model was prespecified for all analyses.

In 'Subgroup analysis and investigation of heterogeneity', subgroup analysis in the protocol was referred to the different types of interventions (i.e. topical, oral, mechanical, etc), which were analysed in separate comparisons. Subgroup analysis in the review referred to subgroup analysis within a comparison.

Because of the large number of randomised studies included in this review, non‐randomised controlled studies were not listed as mentioned in the protocol.

Notes

This review is being updated by way of a new protocol and then a review, because the scope of the review has been reduced to make it more manageable. The citation for the new protocol is as follows: Foley K, Gupta AK, Martin G, Tweed JA, Villanueva E, Carviel J. Topical treatments and photodynamic therapy for actinic keratosis of the face and scalp. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No.: CD013452. DOI: 10.1002/14651858.CD013452.

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.