JMIR Publications

ABSTRACT

Background:

Chest X-ray (CXR) based screening is critical for improving Tuberculosis (TB) case detection in high-burden settings, where a substantial proportion of cases are subclinical or asymptomatic with only radiographic evidence of TB. Although the WHO recommends the use of CXR for active TB screening among high-risk populations, access to conventional digital radiography remains limited in peripheral and resource-constrained settings. Recent advances in ultraportable, handheld X-ray devices offer a promising alternative to radiographic evaluation generating interest in their indigenization and ease of programmatic deployment. However, handheld X-ray devices require systematic validation against standard digital radiography for safer and efficient deployment

Objective:

This validation protocol describes the process for systematic evaluation of adequacy of image quality and diagnostic accuracy of CXR images for TB screening. The study aims to provide a standard comparison for evaluation of the quality of CXR images produced by ultraportable handheld X-ray against conventional digital X-ray systems.

Methods:

This protocol describes a cross-sectional paired comparison study to evaluate the image quality and diagnostic adequacy of CXRs acquired using handheld devices relative to standard digital radiography. Adults aged ≥18 years indicated for CXR examination will be consecutively enrolled until a target enrollment (sample size) of 100 participants is reached. Each participant will undergo two standard postero-anterior CXR examinations, one using a handheld X-ray device and one using a standard digital system. Anonymized images will be independently assessed by two senior radiologists using image quality criteria, including anatomical coverage, spatial resolution, exposure, penetration, positioning, and overall interpretability, that would standardize the CXR for reading and interpretation of Chest X-ray including detection of lung abnormalities consistent with TB. The primary outcome will be the limits of agreement between handheld and standard devices based on overall image quality scores. Agreement in abnormality detection and inter-reader reliability will be assessed using Cohen’s kappa statistics, with standard digital radiography as the reference.

Results:

The study has been initiated at ICMR- Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna. The study protocol underwent ethical review and was approved by the Institutional Ethics Committee.

Conclusions:

The proposed protocol helps to create a common pathway for normalizing and standardizing portable hand-held Xray by providing a broad overview on the parameters to be assessed, the methodology to be used for comparison for successful deployment in remote areas without compromising on accuracy of detection.