Standardising and Assessing Digital Images for Use in Clinical Trials: A Practical, Reproducible Method That Blinds the Assessor to Treatment Allocation

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.

The Importance of Scabies Coinfection in the Treatment Considerations for Impetigo

“…22 The only microbiological association with the presence of scabies in the trial was an increased chance of detecting S. pyogenes (odds ratio, 2.2; 95% CI: 1.1-4.4%). 20 Microbiology alone cannot explain this difference in treatment success.…”

“…Treatment success was defined as any sore that was deemed to have improved or healed by day 7 when paired digital images of the sores were viewed by expert assessors, blinded to treatment allocation. 7,20 In participants with 2 assessed sores in the severe group, both were required to have been successfully treated.…”

Engagement, Empowerment and Patient Generated Health Data

“…In 2012 images taken on cameras by research assistants were used to accurately predict infection healing rates in a randomised controlled trial of skin sores in remote Australian communities (Bowen et al, 2014). Therefore, in this research, images taken on mobile phones were used for the detection of surgical site infections.…”

“…Participants were invited to attend a 30-minute training session to learn how to take medical photographs the day after their child underwent laparoscopic appendectomy surgery similar to the process detailed by Bowen et al (2014). Participants were provided with an overview of the training session and were asked to read and sign consent forms Appendix H and Appendix H. Care was taken to ensure the parents and children knew that the training session could be stopped at any time, and if they experienced discomfort they could withdraw from the study.…”

“…Participants were provided with an overview of the training session and were asked to read and sign consent forms Appendix H and Appendix H. Care was taken to ensure the parents and children knew that the training session could be stopped at any time, and if they experienced discomfort they could withdraw from the study. The session included the following: All images were assessed for usability by a qualified medical photographer using a predefined quality check (Bowen, et al, 2014) that has been modified for this research (Appendix F). Parents who took more than two consecutive images deemed unable to be interpreted were contacted.…”