Immediate reporting of chest X-rays referred from general practice by reporting radiographers
| ISRCTN | ISRCTN21818068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21818068 |
| Secondary identifying numbers | 34539 |
- Submission date
- 19/06/2017
- Registration date
- 20/06/2017
- Last edited
- 10/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
When compared to other common cancers, lung cancer patients are less likely to survive their cancer. This is often due to a delay in the recognition of the condition and performance of the chest X-ray (CXR). Delayed diagnosis reduces treatment choices because the cancer may have spread further and the person may have become too ill for treatment to be given safely. It is hoped that by diagnosing lung cancer sooner this will help improve survival, help with patient satisfaction and potentially extend the range of treatment options, which are more limited in delayed diagnosis. CXRs are often used when lung cancer is suspected, but there can be long delays for the results to be available to the patient and the GP. Radiographers traditionally take the X-ray, but they are reported by a radiologist, a medical specialist. Recent studies show that radiographers who have completed further training can report CXRs with similar accuracy to radiologists. This project will help to reduce delays in diagnosis for lung cancer in two ways. First, a trial of immediate reporting of GP requested CXRs may help to reduce delays and allow further tests to be performed sooner. Second, it is hoped having quicker access to results will reduce the number of patients who need to see a specialist. This should both reduce specialist referrals and anxiety. Based on previous work, so that patients have the best information about their care, and are able to make informed decisions, have constructed an information leaflet which will be distributed to general practitioners. This will be given to patients when they are referred for a CXR, explaining that further tests may be required, and some of the reasons for this. Hopefully this will help to reduce patient anxiety and give them insight into the pathway.
Who can participate?
Adults aged 16 and older who are referred for a chest x-ray.
What does the study involve?
Participants are randomly allocated to one of two groups using block randomisation at session (half day level). Those in the first group receive immediate reporting of chest X-rays referred by general practice, with CT chest when indicated. Those in the second group receive the standard level of care. This includes the routine reporting of chest X-rays referred by general practice. Participants are followed up to see how long it takes to diagnose lung cancer or how long it took to be discharged from the lung cancer pathway and to evaluate the effectiveness of immediate reporting of chest X-rays by general practice.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Hometon University Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2016 to January 2019
Who is funding the study?
Cancer Research UK (UK)
Who is the main contact?
Mr Nick Woznitza (Public)
nicholas.woznitza@nhs.net
Contact information
Public
Radiology Department
Homerton University Hopsital
Homerton Row
London
E9 6SR
United Kingdom
 ORCID ID |
0000-0001-9598-189X |
|---|---|
| Phone | +44 208 510 5315 |
| nicholas.woznitza@nhs.net |
Study information
| Study design | Randomised; Interventional; Design type: Diagnosis, Process of Care, Imaging |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway |
| Study acronym | radioX |
| Study objectives | Immediate reporting of chest X-rays from general practice will reduce the time to diagnosis of lung cancer. |
| Ethics approval(s) | London – Brent REC, 05/06/2017, ref: 17/LO/0870 |
| Health condition(s) or problem(s) studied | Specialty: Health services and delivery research, Primary sub-specialty: Health Services and Delivery Research; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs, Respiratory/ Other diseases of the respiratory system |
| Intervention | Participants are randomly allocated to one of two groups using block randomisation at session (half day level). Group 1: Participants receive immediate reporting of chest X-rays referred by general practice, with CT chest when indicated. Group 2: Participants receive the standard level of care. This includes the routine reporting of chest X-rays referred by general practice. Participants are followed up to see how long it takes to diagnose lung cancer or how long it took to be discharged from the lung cancer pathway and to evaluate the effectiveness of immediate reporting of chest X-rays by general practice. |
| Intervention type | Other |
| Primary outcome measure | Time (in days) to decision to treat (with intermediate time points) for lung cancer or discharge from the lung cancer pathway is measured using patient records at the time where there is a decision to treat or to be discharged from the lung cancer pathway. |
| Secondary outcome measures | 1. Number of CT scans requested is measured using the number of CT chest scans through Radiology Information System at study completion 2. Survival is measured using aggregate data from cancer waiting time reporting at six and 12 months 3. Emergency admissions are measured using data from cancer waiting time reporting at study completion 4. Performance status is measured using data from cancer waiting time reporting at time of decision to treat 5. Number of urgent respiratory cancer referrals are measured from respiratory department records at study completion 6. Relative accuracy and usefulness of chest X-rays reporting by radiographers and consultant radiologists are measured using index diagnosis of thoracic radiologist and/or CT chest within 2 weeks of chest X-ray 7. Number of first 2WW appointments with all radiology results measured using clinician recorded data at time of appointment 8. Cost-effectiveness is measured using QALYS (Quality adjusted life years) at study completion 9. Patient satisfaction is measured using patient questionnaires at two weeks after chest x-ray |
| Overall study start date | 11/07/2016 |
| Completion date | 30/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 4000; UK Sample Size: 4000 |
| Key inclusion criteria | 1. Patients referred for a chest X-ray from general practice 2. Over 16 years |
| Key exclusion criteria | 1. Active diagnosis of lung cancer 2. Aged under 16 years 3. Chest X-rays referrals from any other practitioner (Emergency Department, Inpatient, Outpatient) |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 30/06/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
E9 6SR
United Kingdom
Sponsor information
Hospital/treatment centre
N Holmes Road, Canterbury
Canterbury
CT1 1QU
England
United Kingdom
"ROR" |
https://ror.org/0489ggv38 |
|---|
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Trial protocol to be submitted for peer review August 2017. Final results planned publication in a high-impact peer reviewed journal June 2019. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | primary outcome report | 01/01/2019 | 12/12/2019 | Yes | No |
| Protocol article | protocol | 06/11/2017 | 12/12/2019 | Yes | No |
| Results article | 08/11/2022 | 10/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/11/2022: Publication reference added.
15/02/2020: The intention to publish date has been changed from 31/07/2020 to 31/12/2021.
08/01/2020: The intention to publish date has been changed from 30/06/2019 to 31/07/2020.
12/12/2019: Publication references added.
16/01/2018: The plain English summary has been added.
16/10/2017: Internal review.
11/08/2017: Internal review.
