Keywords
cluster randomized controlled trial; reporting guideline; case report; CARE; radiology
Radiological case reports summarize the imaging characteristics of individual cases to identify patterns and valuable lessons. Their writing can be guided by the CARE reporting guidelines or the CARE-radiology reporting guidelines. However, the impact of following these guidelines, or not following them, on the quality and efficiency of radiological case reports writing remain unclear.
To examine whether following the CARE reporting guidelines or the CARE-radiology reporting guidelines, or not following any reporting guidelines, affects the quality and writing efficiency of radiological case reports.
The purpose of this protocol is to outline the background and objectives of this study, as well as the design of a cluster randomized controlled trial (cRCT). We will design a three-arm, multicentre cRCT, targeting radiologists or radiology students from different medical institutions. The intervention include training on the CARE-radiology checklist; the second intervention involves training on the CARE checklist. The control group will follow standard procedures without any intervention. After the intervention, participants will be required to write a case report within a period of 10 days. The primary outcome measures will be the completeness and clarity of the case reports.
This study aims to enhance the adherence of researchers to reporting guidelines for case reports through rigorous design. The results will be further explained and interpreted in the final trial outcomes.
This study has been registered with the Chinese Clinical Trial Registry, with the registration number: ChiCTR2400089973.
cluster randomized controlled trial; reporting guideline; case report; CARE; radiology
Case reports, as a type of research design or method, provide detailed descriptions of medical issues concerning individual patients, typically focusing on rare or newly identified cases.1 Although they are not considered high-level evidence, they hold significant value in the discovery of new diseases or patterns.2 Radiological case reports are an important branch of case reports, distinct from radiology diagnostic reports. Radiological case reports primarily focus on the imaging characteristics and diagnostic evaluations of a specific disease or symptom, making them a subtype of case reports.3 They primarily present information related to disease diagnosis, offering references for healthcare professionals in clinical diagnosis and treatment.
In the field of radiology, case reports with potential publication value include those on newly identified diseases, rare conditions, unusual imaging findings of known diseases, new techniques, methods, and models in radiology, lessons learned from imaging diagnoses, and analyses of missed or misdiagnosed cases.4 However, there is a widespread issue of substandard report quality in case reports.5,6 To address this, researchers have developed various reporting standards to enhance quality, among which the CARE guidelines for case reports are well-known.7 Additionally, the CARE-radiology reporting guidelines are also part of this effort for radiological case reports.3
The CARE guidelines were first published in multiple journals in 20138–12 and were further refined before being published in the Journal of Clinical Epidemiology in 2017.7 The CARE-radiology reporting standards were published in 20243 and have since been adopted and incorporated into submission guidelines by many journals, organizations, and institutions. However, it remains unclear to what extent using reporting guidelines, either the CARE guidelines or the CARE-radiology guidelines, improves the quality and efficiency of case report writing by radiologists compared to not using any reporting guidelines. Therefore, we plan to conduct a cluster randomized controlled trial (cRCT) to investigate whether adherence to the CARE or CARE-radiology guidelines enhances the quality and efficiency of writing radiological case reports.
2.1.1 Type of study: multicentre cRCT.
2.1.2 Participants: Radiologists or radiology students from different healthcare institutions.
2.1.3 Intervention 1: Required to study the CARE-radiology checklist and receive training on the CARE-radiology checklist
2.1.4 Intervention 2: Required to study the CARE checklist and receive training on the CARE checklist.
2.1.5 Control group: Routine practice with no intervention.
2.1.6 Study sites: Radiology or clinical departments of university-affiliated hospitals and county-level or community health centres.
This study will adopt a cRCT design, divided into three arms, with participants randomly assigned to different groups. The first group is the intervention group 1, where participants will receive training on the CARE-radiology checklist before writing radiological case reports. The second group is intervention group 2, where participants will receive training on the CARE checklist before writing radiological case reports. The third group is the control group, where participants will write radiological case reports using standard methods without any intervention. The training experts are from the CARE-Radiology working group and are very familiar with both the CARE and CARE-radiology checklists. The training materials have undergone strict discussion and standardization. A specific study flowchart is shown in Figure 1.
2.2.1 Participants and research sites
The study subjects will be medical professionals with a certain level of radiology knowledge, including radiologists and medical students specializing in radiology. All participants will be recruited from the radiology departments of the same hospital or multiple hospitals, as well as primary healthcare institutions (including radiology departments of county-level hospitals and community health service centres of city-level hospitals), to ensure homogeneity within the group. Participants must agree to participate in the study, and completion of the case report writing as required will serve as informed consent. To avoid contamination, participants from the same hospital or institution will be assigned to the same group and will receive the same intervention. The research sites will be the radiology departments of tertiary hospitals or primary hospitals. The hospitals participating in the study will be in five provinces and municipalities in China: Beijing, Shanghai, Guangdong, Sichuan, and Gansu, which are distributed across the east, west, south, and north of China, providing strong regional representation.
2.2.2 Randomization
To reduce selection bias, participants will be allocated to the intervention and control groups according to randomization principles. The randomization process will use a computer-generated random number table to ensure fairness and transparency in the allocation process. Randomization will be performed by hospital or department rather than by individual, to avoid cross-contamination of information between groups. Stratification will occur prior to randomization based on region and hospital level. Once a medical institution has completed its randomization, the final subjects will be determined through open recruitment within the institution. For example, if a medical institution has only four diagnostic physicians, all will be included; if there are more than four, the first four individuals recruited will be included as subjects.
2.2.3 Blinding
Since participants will receive different types of training interventions (CARE or CARE-Radiology), it is not possible to implement blinding for the interventions. However, the personnel involved in data collection and processing, as well as those evaluating the outcomes, will be blinded; they will not know whether the case reports provided for review by the researchers are based on CARE-Radiology, CARE, or neither.
2.2.4 Interventions
Intervention Group 1: Participants in this group will receive training on the CARE-radiology checklist before writing radiological case reports. The training will include the background of the checklist, its purpose, explanations of each item, and how to apply these items in actual reports. The training will be conducted by the developers of the CARE-radiology checklist through various formats, including lectures, demonstrations, and interactive exercises. The training will primarily consist of 1) a 30-minute online training course focusing on the development of CARE-radiology and its checklist items; 2) a 10-minute online practice session with interactive Q&A. After the training, participants will be required to write a radiological case report based on a provided real case, applying the content learned from the CARE-radiology checklist, with a completion time of 10 days.
Intervention Group 2: Participants in this intervention group will receive training on the CARE checklist before writing radiological case reports. The training content will include the background of the checklist, its purpose, explanations of each item, and how to apply these items in actual reports. The training will be conducted by personnel through various formats, including lectures, demonstrations, and interactive exercises. The training will primarily consist of: 1) a 30-minute online training course focusing on the development of CARE and its checklist items; 2) a 10-minute online practice session with interactive Q&A. After the training, participants will be required to write a radiological case report based on a provided real case, applying the content learned from the CARE checklist, with a completion time of 10 days.
Control Group: Participants in the control group will not receive any form of intervention. They will write radiological case reports using standard methods without learning the CARE-radiology checklist. The writing process and time frame for control group participants will be the same as for the intervention groups to ensure fairness in comparison, with a completion time of 10 days. To ensure fairness, after the trial is completed, the control group will be sent videos and materials from the training of the two intervention groups for their learning.
2.2.5 Sample size
Assuming the proportion of case reports classified as excellent in the untrained control group is π1=30% and it increases to π2=90% after CARE-radiology/CARE training, the average proportion is π=(0.3+0.9)/2=60%, The significance level is α=0.05, and the power of the test (1 - β) is 0.80.13,14 Assuming equal sample sizes for both groups, we can use the formula:
The required sample size for an individual randomized controlled trial is mindivudal = 9。
Assuming each group (cluster) has an average of k = 3 participants, and the intracluster correlation coefficient (ICC) is 0.5, we can calculate the design effect (DE) using the formula:
Calculating the design effect gives us DE = 2。
The sample size needed for each intervention group in the cRCT is calculated to be mcluster = 18. Since each group has 3 participants, there will be 6 groups (clusters) per intervention group (i.e., 18/3). Therefore, this study plans to recruit 18 groups (clusters), with each intervention trial group consisting of 6 groups. The groups will be based in hospitals or primary healthcare institutions, considering both tertiary hospitals and county-level hospitals as well as community health service centres. Each group will recruit 3-4 participants, totalling 54-72 participants. (Note: The dropout rate of the groups has not yet been considered.)
After all participants complete the radiological case reports writing, the research team will collect all related data, along with basic information about the participating hospitals or institutions and baseline information on individual participants. The analysis of the reports will be based on pre-defined outcomes, which include the completeness and transparency of the case reports, as well as the time required to write each case report. Once data collection is complete, the case reports will be sent for independent review by medical editors, methodological experts, clinical specialists, and diagnostic physicians who are blinded to intervention assignments to ensure objectivity and fairness in the evaluations. The reviewers will establish independent criteria to assess each submitted case report individually. All data collection will use a custom-designed data collection form, and the data will be anonymized by designated personnel to prevent any leakage of participant information.
An independent review team (including methodological experts, clinical specialists, radiologists, and journal editors) will score the drafted case reports. Reviewers will be blinded to the intervention status and unaware of each other’s scores and identities. All scores will also be anonymized before being handed over to statisticians for analysis.
2.4.1 Primary outcomes
1) Completeness and clarity of the case reports, scored by radiology experts based on their understanding of the CARE and CARE-radiology guidelines on a scale from 1 (worst) to 7 (best).3,7
2) Risk of bias in submitted case reports, assessed by methodological experts using the JBI case report tool (https://jbi.global/critical-appraisal-tools).15
2.4.2 Secondary outcomes
1) Time required to complete each case report, self-recorded by the participants.
2) Difficulty level of writing the radiology case report, self-rated by participants on a scale from 1 (easiest) to 7 (most difficult).
3) Helpfulness of the reference case report in making a correct diagnosis, scored by clinical specialists on a scale from 1 (minimal help) to 7 (extremely helpful).
4) Suitability for journal publication, rated by journal editors on a scale from 1 (not at all suitable) to 7 (highly suitable for publication).
5) Proportion of compliance with CARE or CARE-radiology guidelines, assessed and calculated by methodological experts.
2.5.1 Routine analysis
We will analyze and compare the score differences in quality indicators between the three groups. First, a descriptive statistical analysis will be conducted to understand the baseline characteristics of each indicator. Then, either a t-test or a non-parametric test (such as the Mann-Whitney U test) will be used to determine if there is a significant difference in average scores between the groups. If the data is not normally distributed, appropriate non-parametric tests will be applied.
2.5.2 Modeling analysis
To further control for confounding factors, we will later apply multivariate regression analysis, multilevel models (hierarchical models), and propensity score matching to enhance the balance between groups and further evaluate the actual effectiveness of the CARE/CARE-radiology checklist. All data analyses will be conducted using statistical software such as SPSS 26.0 (https://www.ibm.com/spss) or R 4.3.3 (https://www.r-project.org/).
This study has been reviewed and approved by Medical Ethics Committee of the First Hospital of Lanzhou University. Ethics approval number is LDYYLL2024-532 and approval date is September 9, 2024. Throughout the study, the privacy and data of case providers and participants will be strictly protected, and all collected data will be anonymized. The study results will be published in aggregate form, ensuring no personal information is disclosed. Before the study commenced, an ethics review was conducted and an application for waiver of informed consent was submitted to the Ethics Committee of the First Hospital of Lanzhou University. Submission of the manuscript is considered consent to participate in the study, so additional informed consent from authors is not required. Informed consent for patient data used in the study will be obtained by the responsible physician, with a consent form signed by the patients.
We anticipate that the quality of radiological case reports in the intervention group may be superior to that of the control group. The study results will help radiologists and educators understand the role of the CARE and CARE-radiology checklist in enhancing case report quality and may encourage broader adoption of the checklist in radiology. Additionally, this study can provide a reference for report writing in other medical fields, promoting the standardization of medical education.
The dataset is owned by the research team, and decisions regarding data analysis and publication are made independently by the steering committee. Research data will be made publicly available following the conclusion of the study through a reasonable application process for researchers. An independent review committee, comprising an independent review team (including 2 methodology experts, 5 clinical experts, 5 radiologists, and 2 journal editors, totaling 14 members), is responsible for independently reviewing submitted case reports. The study management committee, which includes members of the steering committee and representatives or contacts from different institutions, is responsible for the daily management of the study.
Participants require additional time to write case reports and to learn new knowledge, which increases their workload. Blinding may lead to insufficient information disclosure, though these risks are relatively minor. By improving the quality of reporting, this study promotes scientific research in the field of radiological medicine, enhancing the reliability and reproducibility of research outcomes.
This study employs a rigorous cluster randomized controlled trial design to assess the impact of learning the CARE/CARE-radiology reporting guidelines on the quality, effectiveness, and efficiency of radiology case report writing. The goal is to provide a scientific basis for improving report quality and standardization, thereby promoting advancement and progress in the field of radiological medicine.
This study has been reviewed and approved by Medical Ethics Committee of the First Hospital of Lanzhou University. Ethics approval number is LDYYLL2024-532 and approval date is September 9, 2024. Throughout the study, the privacy and data of case providers and participants will be strictly protected, and all collected data will be anonymized. The study results will be published in aggregate form, ensuring no personal information is disclosed. Before the study commenced, an ethics review was conducted and an application for waiver of informed consent was submitted to the Ethics Committee of the First Hospital of Lanzhou University. Submission of the manuscript is considered consent to participate in the study, so additional informed consent from authors is not required. Informed consent for patient data used in the study will be obtained by the responsible physician, with a consent form signed by the patients.
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