Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway (radioX): study protocol for a randomised control trial

A two-way comparative study that will compare the time to diagnosis of lung cancer for patients. Internal comparison will be made between those who receive an immediate radiographer report of a GP CXR compared to standard radiographer GP CXR reporting (Fig. 1). The intervention group will receive an immediate CXR report and be offered a CT for CXRs suspicious for cancer. The control group will have the CXR reported no later than next working day in line with current protocols. Key protocol elements are summarised in the SPIRIT (Standard Protocol Items: Recommendations for Interventional trials) 2013 Checklist [27] (Additional File 1) and Figure (Fig. 2).

The diagnostic aspect of the lung cancer pathway at Homerton University Hospital is relatively streamlined. To enable comparison with radiology service delivery at other institutions’ time to diagnosis (immediate and standard CXR reporting) will be compared with Newham University Hospital (Fig. 2). This adjacent hospital has comparable patient demographics, a similar number of lung cancer patients per year and is of comparable size. Newham does not currently have CXR-reporting radiographers and does not offer a straight-to-CT service for CXRs suspicious for lung cancer.

Research Ethics Committee and Health Research Authority approval was granted on 6 June 2017 (REC 17/LO/0870; HRA 221968). This study will not directly recruit patients; it is an evaluation of health service delivery and, as such, no patient consent is required. Intervention is at an institutional level and institutional approval has been gained. No additional or different tests will be performed, and all the reporting practitioners (reporting radiographers and consultant radiologists) currently report CXRs in clinical practice. The comparative aspect of the study is the timing, accuracy and usefulness of the CXR report; immediate compared to standard care. Patient-identifiable data will not be available outside of the direct clinical care team, only anonymised data will be used. Patients will be assigned a unique study identifier at time of CXR by the clinical care team. Block randomisation, institutional rather than patient enrolment and the use of de-identified data is in line with previous research that has examined the order of interpretation between readers [28]. The intervention is considered to be an alternative, non-inferior form of standard practice since radiographer reporting of CXRs has already been implemented in some NHS trusts in the UK. Radiographer reporting, including CXRs, has been shown to create additional diagnostic capacity at centres that have embedded this into the imaging department [21, 22, 29]. However, the published evidence on radiographer reporting of CXRs is limited. Furthermore, robust methods of evaluating diagnostic reports (including actionability and usefulness) of radiographers and radiologists using independent experts has not previously been attempted.

Clinical assessment will be made by a general practitioner and a referral made to Homerton University Hospital for a CXR examination following standard and established referral procedures. The referral for CXR will be checked by the performing radiographer or supervised assistant practitioner to ensure that the referral meets Ionising Radiation (Medical Exposure) Regulations (IRMER) (2000) requirements and adheres to departmental protocols for a justified referral. Chest X-rays will be obtained using digital radiography equipment, and radiation doses will be as low as possible while maintaining good image quality. Existing departmental imaging protocols will be followed. The standard X-ray projection for a chest examination is a single posterior-anterior (PA) X-ray. The radiographer or assistant practitioner will check all images for diagnostic quality and record the radiation dose on the Radiology Information System (RIS) in line with departmental standard operating procedures. If the radiographer or assistant practitioner performing the CXR identifies a potentially significant abnormality; for example, lung cancer or pneumothorax, this will be triaged for an immediate report according to current protocol.

Inclusion and exclusion criteria are presented in Table 1.

Intervention is at an institutional level; individual patients will not be randomised. Half-day sessions will be randomised to intervention or standard practice, using a randomisation list provided by the study statistician. This is in line with previous studies that have examined the timing or order of X-ray reading but where all examinations are requested as part of routine clinical care and receive reports from the same practitioners [30].

The intervention reporting strategy is modelled on the National Optimal lung cancer pathway developed in 2016 [31]. The intervention strategy aims to streamline the patient journey through the lung cancer pathway by providing prompt interpretation of CXRs referred by general practice (GP) and offering immediate CT when appropriate.

Chest X-rays included in the intervention arm will be reported at the time of image acquisition while the patient is still in the radiology department. Patients who have a CXR suspicious for cancer will be offered an immediate CT of the chest and upper abdomen.

Current practice in most radiology departments is for GP examinations to be reported once the patient has left the department. Considerable variability exists across England in the time taken to report X-ray examinations (report turnaround time; RTAT). At Homerton University Hospital, all GP X-rays are reported during the next reporting session following examination, with a maximum RTAT of one working day. Patients who have a CXR suspicious for cancer are offered an appointment for a CT of the chest and upper abdomen via the radiology department secretary team, with the results sent to the referring GP and the cancer referrals office. Current practice is that if a suspected abnormality is identified by the radiographer who performs the CXR an urgent report (reporting radiographer or consultant radiologist) is arranged while the patient is still in the department. If the findings are suspicious for lung cancer the patent is offered a CT of the chest and abdomen. This protocol will continue throughout the study for the control reporting sessions.

The primary outcome is to test the impact of radiographer immediate reporting of GP CXRs, with immediate CT where appropriate, on time from performance of the CXR to treatment (with intermediate time points)/discharge for lung cancer.

Secondary outcome measures include:

In addition to comparison as per randomisation within Homerton University Hospital, primary outcomes will be compared with a neighbouring hospital, Newham University Hospital.

All reporting radiographers participating in the study have completed an accredited postgraduate certificate in adult CXR reporting (experience 1–8 years) and currently provide CXR reports in clinical practice. All CXRs referred by GP on eligible patients (aged over 16 years, no active history of lung cancer) will receive a reporting radiographer report. In line with current practice, a narrated report will be provided rather than a structured report. Image interpretation will occur on Picture Archiving and Communication System (PACS) workstations and the report entered into PACS and transferred to the patient electronic record. If the reporting radiographer requires additional investigations (repeat X-ray due to inadequate initial X-ray, additional X-ray view, CT of the chest and abdomen), these will be arranged by the reporting radiographer at time of the CXR report.

Where the radiographer performing the CXR is concerned about the appearance of the X-ray or by the clinical condition of the patient, current practice at Homerton University Hospital is for the CXR to be reviewed by a reporting radiographer or a consultant radiologist prior to the patient leaving the department. This includes, for example, where the radiographer suspects a pneumothorax, tuberculosis or cancer. If a radiographer has concerns that the appearances of the CXR is abnormal and a significant pathology may be present, these patients will receive an immediate report, regardless of the reporting session allocation (immediate/standard) so as not to negatively impact on patient management. All such occurrences will be identified, included in the intention-to-treat principle, but we will also carry out sensitivity analysis excluding them. In view of randomisation, we expect the same rates of such cases in intervention and control sessions.

For cases where the reporting radiographer is unsure with the findings, and/or clinical significance of the CXR, they will be free to review the case with another reporting radiographer and/or consultant radiologist. This is in line with current best practice. This will include, for example, instances where previous cross-sectional imaging is available for the patient, or where there may be unfamiliar medical terminology on the CXR request form. All occurrences will be recorded.

All CXRs will receive a consultant radiologist report (general radiologists; experience range 2–21 years post FRCR), blinded to the reporting radiographer CXR report. Consultant radiologist reporting will occur at the next session following the reporting radiographer report. Interpretation will occur using PACS workstations and the report will be entered into a secure database.

The CXR reports generated by the reporting radiographers and consultant radiologists will be extracted, anonymised for source of report (radiographer/radiologist) and entered into a secure database using the unique study identifier. A respiratory physician will compare the reports for discrepancies, using a proforma with predefined criteria for clinically significant abnormalities. Discrepancies in observations, interpretations and recommendations will be highlighted. These criteria have been previously validated [32]. Report comparison will occur within three working days of the CXR examination.

All additional radiology investigations will be organised by the radiology department following established departmental operating procedures. These additional investigations would be performed as part of routine clinical practice and will not require any additional radiation exposure. The reporting radiographers, after appropriate training, have been designated ‘non-medical referrers’ according to IRMER 2000 legislation.

According to British Thoracic Society (BTS) guidance [33], patients who have a CXR that is suspicious for infection require a follow-up CXR 6 weeks later following antibiotic therapy to ensure resolution. The reporting radiographer will arrange the follow-up CXR at the time of the initial CXR report for the immediate reporting arm, and the patient will be asked to re-attend the radiology department in 6 weeks. This will be communicated in the CXR report.

For patients who have a CXR suspicious for infection in the standard care arm the recommendation for a follow-up CXR in 6 weeks will be included in the report conclusion. This will be requested by the general practitioner, as is current practice.

Patients who have an abnormal CXR suspicious for cancer will have a CT of the chest performed. The reporting practitioner (reporting radiographer or consultant radiologist) will arrange this following standard department procedure. The CT scan forms part of routine clinical management and, therefore, does not require any additional radiation exposure. A consultant radiologist will interpret all CTs.

The CT performed will be stratified based on the CXR appearances and the likelihood of cancer. This will minimise radiation exposure, in line with best practice. For patients with a CXR that is suspicious but not categorical for lung cancer, a low-dose, unenhanced CT of the chest will be performed. For patients who have a CXR that shows a high likelihood of cancer, a CT of the chest and abdomen with intravenously administered contrast will be offered

Chest X-rays that are found to have discordant reporting radiographer and consultant radiologist reports at peer review will have an index diagnosis. For cases that have undergone a subsequent CT scan of the chest and abdomen, the CT report will constitute the index diagnosis. CXR reports, either reporting radiographer or consultant radiologist, will be deemed a true positive if CT confirms the CXR diagnosis and a false positive if the CT is normal or another pathology is demonstrated. True positive and true negative will be a consensus decision and corroboration between the CT and clinical history between a respiratory physician and a thoracic radiologist. Assessment of report accuracy will be made blinded to the origin (reporting radiographer/consultant radiologist) of the CXR report.

For cases that have not had a CT performed, an independent expert thoracic consultant radiologist will constitute the index diagnosis. The index radiologist will feed back the diagnosis via a standardised proforma. All available thoracic imaging (X-ray, CT) for the patient will be sent via the Image Exchange Portal (IEP) to the Royal Brompton Hospital. IEP is an established, secure method of transferring radiology cases for external review within the NHS. A thoracic consultant radiologist will review the available imaging and provide the definite diagnosis. CXR reports, both reporting radiographer and consultant radiologist, will be deemed a true positive if the thoracic radiologist confirms the CXR diagnosis and a false positive if the thoracic radiologist interpretation is normal or another pathology is demonstrated.