↓ Skip to main content

Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned

Overview of attention for article published in Journal of Foot and Ankle Research, July 2016
Altmetric Badge

Mentioned by

twitter
3 X users

Citations

dimensions_citation
1 Dimensions

Readers on

mendeley
46 Mendeley
You are seeing a free-to-access but limited selection of the activity Altmetric has collected about this research output. Click here to find out more.
Title
Implementation of blinded outcome assessment in the Effective Verruca Treatments trial (EverT) – lessons learned
Published in
Journal of Foot and Ankle Research, July 2016
DOI 10.1186/s13047-016-0155-4
Pubmed ID
Authors

Sarah Cockayne, Catherine Hewitt, Farina Hashmi, Kate Hicks, Michael Concannon, Caroline McIntosh, Kim Thomas, Jill Hall, Judith Watson, David Torgerson, Ian Watt

Abstract

Trials using inadequate levels of blinding may report larger effect sizes than blinded studies. It has been suggested that blinded outcome assessment in open trials may in some cases be undertaken by assessments of photographs. The aim of this paper is to explore the effect of using different methods to assess the primary outcome in the EVerT (Effective Verruca Treatments) trial. It also aims to give an overview of the experiences of using digital photographs within the trial. We undertook a secondary analysis to explore the effect of using three different methods to assess the primary outcome in the EVerT trial: assessment of digital photographs by blinded healthcare professionals; blinded healthcare professional assessment at the recruiting site and patient self-report. The verruca clearance rates were calculated using the three different methods of assessment. A Cohen's kappa measure of inter-rater agreement was used to assess the agreement between the methods. We also investigated the experiences of healthcare professionals using digital photographs within the trial. Digital photographs for 189 out of 240 (79 %) patients in the trial were received for outcome assessment. Of the 189 photographs, 30 (16 %) were uninterpretable. The overall verruca clearance rates were 21 % (43/202,) using the unblinded patient self-reported outcome, 6 % (9/159,) using blinded assessment of digital photographs and 14 % (30/210,) using blinded outcome assessment at the site. Despite differences in the clearance rates found using different methods of outcome assessment, this did not change the original conclusion of the trial, that there is no evidence of a difference in effectiveness between cryotherapy and salicylic acid. Future trials using digital photographs should consider individual training needs at sites and have a backup method of assessment agreed a priori. ISRCTN Registry ISRCTN18994246.

X Demographics

X Demographics

The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 46 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 46 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 11 24%
Researcher 9 20%
Other 2 4%
Student > Ph. D. Student 2 4%
Student > Postgraduate 2 4%
Other 6 13%
Unknown 14 30%
Readers by discipline Count As %
Medicine and Dentistry 16 35%
Nursing and Health Professions 5 11%
Agricultural and Biological Sciences 2 4%
Business, Management and Accounting 1 2%
Pharmacology, Toxicology and Pharmaceutical Science 1 2%
Other 5 11%
Unknown 16 35%