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 without major symptoms, with only radiographic evidence of TB. However, 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 for chest imaging in such settings. In order to use handheld Xray devices in place of conventional digital radiography, the primary requisite is to establish whether the handheld device produces images of comparable quality to the conventional system, and subsequently, whether the images demonstrate comparable adequacy for identification of radiographic abnormalities.

Objective:

This validation protocol describes the process for systematic evaluation of CXR images produced by ultraportable handheld X-ray device compared with those produced by conventional digital X-ray systems. The primary objective is to assess and compare the image quality of CXR produced by the two devices. The secondary objective is to assess inter-device agreement in the diagnostic adequacy of CXR for detection of abnormalities.

Methods:

This cross-sectional paired comparison study will evaluate the image quality and diagnostic adequacy of CXRs acquired using handheld device versus standard digital radiography. Adults aged ≥18 years referred for CXR examination will be consecutively enrolled until 100 participants are recruited. Each participant will undergo two standard postero-anterior (PA) views, one using a handheld X-ray device and one using a standard digital system. All images will be anonymized and independently assessed by two radiologists using predefined image quality criteria, including anatomical coverage, spatial resolution, exposure, penetration, positioning, and overall interpretability, to provide a standardized objective assessment of CXR image quality and detection of lung abnormalities consistent with TB. The primary outcome will be agreement in overall image-quality scores between handheld and standard digital X-ray devices, assessed using Bland-Altman analysis and corresponding limits of agreement. Secondary outcome will include diagnostic adequacy and the detection of CXR abnormalities, with standard digital device serving as the reference imaging modality. Inter-device and inter-reader reliability will be assessed using Cohen’s kappa or Gwet’s AC1 statistics, as appropriate. The protocol was reviewed and approved by the Institutional Ethics Committee.

Results:

The study has been initiated at ICMR- Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna. The results of the study will be reported after data collection and analysis.

Conclusions:

This protocol provides a standardizing framework for evaluating ultraportable handheld X-ray systems, encompassing key parameters for comparative assessment of image quality and diagnostic adequacy for TB screening. This approach can support the deployment ultraportable X-ray systems in remote areas without compromising on accuracy of detection. Clinical Trial: The study protocol was not registered at Clinical Trial Registry-India (CTRI).