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Standardising and assessing digital images for use in clinical trials: a practical, reproducible method that blinds the assessor to treatment allocation.

Bowen AC, Burns K, Tong SY, Andrews RM, Liddle R, O'Meara IM, Westphal DW, Carapetis JR - PLoS ONE (2014)

Bottom Line: With the increasing availability of high quality digital cameras that are easily operated by the non-professional photographer, the utility of using digital images to assess endpoints in clinical research of skin lesions has growing acceptance.However, rigorous protocols and description of experiences for digital image collection and assessment are not readily available, particularly for research conducted in remote settings.We describe the development and evaluation of a protocol for digital image collection by the non-professional photographer in a remote setting research trial, together with a novel methodology for assessment of clinical outcomes by an expert panel blinded to treatment allocation.

View Article: PubMed Central - PubMed

Affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Royal Darwin Hospital, Darwin, NT, Australia; Telethon Kids Institute for Child Health Research, University of Western Australia, Perth, WA, Australia; Princess Margaret Hospital for Children, Perth, WA, Australia.

ABSTRACT
With the increasing availability of high quality digital cameras that are easily operated by the non-professional photographer, the utility of using digital images to assess endpoints in clinical research of skin lesions has growing acceptance. However, rigorous protocols and description of experiences for digital image collection and assessment are not readily available, particularly for research conducted in remote settings. We describe the development and evaluation of a protocol for digital image collection by the non-professional photographer in a remote setting research trial, together with a novel methodology for assessment of clinical outcomes by an expert panel blinded to treatment allocation.

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Related in: MedlinePlus

This shows the database format utilised for scoring digital image pairs. Image A was taken on day 0 and image B on day 7.Image B shows erythema and as such was scored as improved using the definitions in table 4.
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pone-0110395-g008: This shows the database format utilised for scoring digital image pairs. Image A was taken on day 0 and image B on day 7.Image B shows erythema and as such was scored as improved using the definitions in table 4.

Mentions: The primary outcome for the RCT was treatment success at day 7 according to paired digital image scoring. After the successful pilot, the digital image pairs were organised in random order in a purpose built database (figure 8) using the randomly assigned number between 0 and 15 000 as the only identifying information. Scoring of the digital image pairs was on non-standardised computer screens at locations remote from the primary study site. Scoring was by a group of eight paediatricians with expertise in caring for Indigenous children with impetigo. Primary outcome reviewers blinded to treatment allocation were provided pairs of images from day 0 and 7 (or day 0 and 2) in random order. Each reviewer was unaware of which image (A or B) was pre- or post-treatment and was asked to decide if image A, compared to image B, was healed, improved, the same, worse, or unable to be determined using the definitions (table 4) and vice versa (i.e., image B compared to image A). To expedite this process, an auto-fill was used in the database. For example, when image A was scored as “worse”, auto-fill made available the options of “healed” or “improved” only for the comparison of image B to image A. Where “healed” or “improved” were selected for image A, auto-fill completed the scoring with “worse” for image B. The use of auto-fill made the scoring process as rapid as possible. Thus reviewers were blinded to both treatment allocation and the chronological order of sores. Every image pair was evaluated by two independent reviewers from the panel of eight. Where disagreements occurred, an expert panel of three determined the final result by consensus.


Standardising and assessing digital images for use in clinical trials: a practical, reproducible method that blinds the assessor to treatment allocation.

Bowen AC, Burns K, Tong SY, Andrews RM, Liddle R, O'Meara IM, Westphal DW, Carapetis JR - PLoS ONE (2014)

This shows the database format utilised for scoring digital image pairs. Image A was taken on day 0 and image B on day 7.Image B shows erythema and as such was scored as improved using the definitions in table 4.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4222834&req=5

pone-0110395-g008: This shows the database format utilised for scoring digital image pairs. Image A was taken on day 0 and image B on day 7.Image B shows erythema and as such was scored as improved using the definitions in table 4.
Mentions: The primary outcome for the RCT was treatment success at day 7 according to paired digital image scoring. After the successful pilot, the digital image pairs were organised in random order in a purpose built database (figure 8) using the randomly assigned number between 0 and 15 000 as the only identifying information. Scoring of the digital image pairs was on non-standardised computer screens at locations remote from the primary study site. Scoring was by a group of eight paediatricians with expertise in caring for Indigenous children with impetigo. Primary outcome reviewers blinded to treatment allocation were provided pairs of images from day 0 and 7 (or day 0 and 2) in random order. Each reviewer was unaware of which image (A or B) was pre- or post-treatment and was asked to decide if image A, compared to image B, was healed, improved, the same, worse, or unable to be determined using the definitions (table 4) and vice versa (i.e., image B compared to image A). To expedite this process, an auto-fill was used in the database. For example, when image A was scored as “worse”, auto-fill made available the options of “healed” or “improved” only for the comparison of image B to image A. Where “healed” or “improved” were selected for image A, auto-fill completed the scoring with “worse” for image B. The use of auto-fill made the scoring process as rapid as possible. Thus reviewers were blinded to both treatment allocation and the chronological order of sores. Every image pair was evaluated by two independent reviewers from the panel of eight. Where disagreements occurred, an expert panel of three determined the final result by consensus.

Bottom Line: With the increasing availability of high quality digital cameras that are easily operated by the non-professional photographer, the utility of using digital images to assess endpoints in clinical research of skin lesions has growing acceptance.However, rigorous protocols and description of experiences for digital image collection and assessment are not readily available, particularly for research conducted in remote settings.We describe the development and evaluation of a protocol for digital image collection by the non-professional photographer in a remote setting research trial, together with a novel methodology for assessment of clinical outcomes by an expert panel blinded to treatment allocation.

View Article: PubMed Central - PubMed

Affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Royal Darwin Hospital, Darwin, NT, Australia; Telethon Kids Institute for Child Health Research, University of Western Australia, Perth, WA, Australia; Princess Margaret Hospital for Children, Perth, WA, Australia.

ABSTRACT
With the increasing availability of high quality digital cameras that are easily operated by the non-professional photographer, the utility of using digital images to assess endpoints in clinical research of skin lesions has growing acceptance. However, rigorous protocols and description of experiences for digital image collection and assessment are not readily available, particularly for research conducted in remote settings. We describe the development and evaluation of a protocol for digital image collection by the non-professional photographer in a remote setting research trial, together with a novel methodology for assessment of clinical outcomes by an expert panel blinded to treatment allocation.

Show MeSH
Related in: MedlinePlus