Guidelines Regarding §16 of the German Transplantation Act – Initial Experiences with Structured Reporting

Abstract

Purpose To transfer the report sheet from the guidelines regarding the German Transplantation Act to a standards-compliant report template and to evaluate it in the clinical routine.

Materials and Methods The template was developed using the freely available software brackets.io. It was implemented in the clinical routine using a reporting platform developed in-house. Interfaces to the department RIS and PACS allowed for integration into the usual reporting workflow. The evaluation period was 70 days.

Results Developing the template for implementation of the guidelines was possible without any difficulties. The content of the report sheet provided in the guidelines was transferred one to one. Additionally, a text field was included to allow for further remarks. In the period under review, 7 radiologists performed 44 evaluations in line with § 16 of the German Transplantation Act. Users of the template, referring physicians and the employees of the transplantation office reported a high degree of satisfaction.

Conclusion Implementing report sheets that are required by law (e. g. in the guidelines regarding § 16 of the German Transplantation Act) in the clinical routine electronically is easy and achieves a high degree of acceptance. The standard supported by the German Radiological Society (IHE – "Management of radiology report templates") allows for a quick response to the growing demand for structured and standardized reporting.

Key Points 

• Report sheets as required by law can easily be incorporated electronically into the clinical routine.

• Templates for structured reporting as supported by the German Radiological Society allow for a quick response to the growing demand for standardized reporting.

• Radiologists as well as referring physicians report a high degree of satisfaction with the electronic version of the report sheet.

Citation Format

• Pinto dos Santos D, Arnhold G, Mildenberger P et al. Guidelines Regarding §16 of the German Transplantation Act – Initial Experiences with Structured Reporting. Fortschr Röntgenstr 2017; 189: 1145 – 1151

Key words

abdomen - CT - health policy and practice - technology assessment - transplantation - MR imaging

Introduction

The amended version of the organ transplantation guidelines pursuant to § 16 of the German Transplantation Act took effect on 5/17/2016, assigning radiology a special role in the evaluation and documentation of the disease stage and course in patients with hepatocellular carcinoma and thus in the determination of an indication for liver transplantation [1]. The guidelines require a standardized radiology report sheet for this purpose ([Fig. 1]). Information regarding the number and morphology of liver lesions suspicious for HCC is to be provided in this sheet. Similar efforts to create partially standardized report sheets are increasingly being made in other contexts, e. g., in the certification of oncological centers. The amendment of the guidelines does not provide details regarding the implementation of this report sheet but it can be assumed that a paper version of the sheet will be used at many clinics.

Fig. 1 a Report sheet taken from the guidelines regarding organ transplantation pursuant to § 16 of the German Transplantation Act. b IHE MRRT-compliant implementation in HTML5 without design information and with disabled JavaScript.

Therefore, it seems desirable to meet these requirements with suitable technical tools that not only simplify documentation and archiving but ideally also support the radiology workflow and that can be flexibly adapted to changing and growing demands.

One possibility for meeting these demands is to create structured IT-based report sheets, the advantages and disadvantages of which are being increasingly discussed by radiological societies particularly recently [2] [3] [4] [5]. The majority of professional societies are in favor of greater standardization and structuring of radiological reports [6]. As a result of the Reporting Initiative of the Radiological Society of North America (RSNA), numerous developments were initiated resulting in the preliminary publication of the IHE-MRRT profile (Integrating the Healthcare Enterprise, Management of Radiology Report Templates) [7] [8]. This profile provides the technical details for the development of structured report templates. Templates are to be created as simple HTML5 files with the IHE profile defining some restrictions. Dynamic elements can be added, e. g. per JavaScript, to support radiologists [9].

Structured reporting according to IHE MRRT currently plays only a limited role in the clinical routine. This could be due to the early development stage of the profile, the lack of support by major manufacturers and the lack of German templates. The German Radiological Society has defined the resolving of this issue and promoting of structured reporting as one of its central projects in the coming years (http://www.befundung.drg.de/).

At the University Medical Center Mainz, we were able to develop our own in-house open-source platform (www.mrre.org) for using IHE-compliant report templates [10]. The reporting platform was programmed in HTML/PHP/MySQL and offers a generic approach allowing use of any IHE-MRRT-compliant report template. Such templates can already be downloaded from the RSNA website (http://www.radreport.org), for example.

The goal of the present study was to transfer the sheet required by the guidelines regarding the German Transplantation Act to a dedicated MRRT-compliant template and to evaluate the use of the template in the clinical routine.

Materials and Methods

The free software Brackets (http://brackets.io) was used to create and test the template (HTML and JavaScript). When creating the template, standards compliance was ensured with the help of the published MRRT profile [8]. In addition, the fields of the template were assigned RadLex codes where possible. The corresponding RSNA website (http://purl.bioontology.org/ontology/RADLEX) was used as a reference.

The template was then imported into the above-mentioned reporting platform and was able to be used there after radiologists received brief training regarding the creation of structured reports ([Fig. 2]). The already established interfaces between the reporting platform, RIS (i-Solutions Health GmbH, Mannheim) and PACS (Sectra AB, Linköping, Sweden) allowed simple integration into the clinical routine [10]. Reports created with the help of the reporting platform could be sent as a DICOM-PDF to the hospital-wide PACS so that they could be viewed by employees of the transplantation office at any time. At the same time, all entries made in the template were automatically saved in the dedicated database of the reporting platform and were accessible for additional analysis and evaluation.

Fig. 2 a Template within the reporting platform with data entered by the reporting radiologist. Lesions are only shown in the number needed and chosen, and help buttons are added through JavaScript. Tooltip shows how to choose the value for the respective field. b The final report in the HTML view. The formatting is preserved for the export as DICOM-Encapsulated-PDF and can be sent to the PACS.

Once the amendment to the guidelines regarding the German Transplantation Act came into effect, all report requests were electronically processed with the created template. The evaluation period was 70 days from May to August 2016.

User feedback was collected and documented particularly in the development phase both in joint meetings and during use. For more objective evaluation of user satisfaction, participants were asked after conclusion of the evaluation period to complete an electronic feedback form created via SurveyMonkey (https://www.surveymonkey.de). Responses were recorded using a 5-point Likert scale [11].

Results

A dedicated template for guideline implementation was able to be created without difficulty. In addition to reproducing the report sheet from the guidelines in MRRT-compliant HTML, several tools were added in JavaScript to simplify use in the clinical routine. Therefore, the number of fields displayed for lesion evaluation corresponds to the specified number of actual lesions instead of the fields for five lesions that are always displayed on the paper sheet and often remain blank. Moreover, a "comments" text field that was not included in this form in the sheet proposed in the guidelines was added. It became clear early on that it was essential to give the reporting radiologist the opportunity to add comments. This is important particularly when different radiologists need to perform structured documentation of re-staging examinations which can be numerous depending on the wait time for an organ. Moreover, a function that automatically suggests whether the patient currently meets the Milan criteria was implemented. This is intended not only to make the radiologist's job easier but also to eliminate a potential source of error. Internal rules were also added as a Tooltip so that the relevant criteria for a particular field are again displayed to the radiologist prior to every click on a field ([Fig. 2a]). The template was developed so that it can be used even with JavaScript fully disabled since the IHE-MRRT profile allows the use of JavaScript but specifies that it is not necessarily supported by other reporting platforms. Development and completion of the template required approximately eight man hours.

The template was able to be imported into the reporting solution without errors and was able to be used immediately. The platform allowed completely digital documentation and could be fully integrated into an existing RIS/PACS environment.

In the 70-day study period, 44 requests for evaluation and reporting according to the guidelines regarding the German Transplantation Act were made and processed by 7 radiologists with abdominal imaging experience.

Since all findings were stored in the database of the reporting platform, further reports can also be created, e. g., the percentage of patients with a solitary HCC (17 of 44 cases in our collective) ([Fig. 3]).

Fig. 3 The reports are stored in the database and are readily available for graphical evaluation and analysis.

In general, template users as well as participating referring physicians and employees of the transplantation office reported a high level of satisfaction already in the development phase. At the end of the evaluation period, 15 referring physicians and 7 radiologists participated in the electronic satisfaction survey. In general, both the referring physicians and radiologists were highly satisfied (median total = 4.5; median for referring physicians = 4; median for radiologists = 5). All surveyed radiologists and most referring physicians indicated that the electronic version was preferable to the paper-based one (median total, referring physicians and radiologists = 5). Also in relation to usability, clearness, and availability, there was a high level of satisfaction with the electronic version of the sheet ([Table 1]). The complete digitalization and thus the lack of a need to switch media to use paper-based sheets were consistently specified as the greatest strengths. The most common critical feedback related less to the template than to a lack of clarity in relation to the content of the guidelines regarding the German Transplantation Act.

Table 1 Results of the questionnaires sent to radiologists and clinicians about the degree of satisfaction with the electronic report sheet from the guideline to the German Transplantation Act.

question	n answer 1	n answer 2	n answer 3	n answer 4	n answer 5	median
radiologists (n = 7)	very dissatisfied	dissatisfied	indifferent	satisfied	very satisfied
overall, how satisfied are you with the electronic version of the organ transplantation sheet?	0	0	0	3	4	4.5
	very poor	poor	no opinion	good	very good
usability of the template	0	0	0	1	6	5
processing speed	0	0	0	3	4	5
reliability of the technical implementation	0	0	0	3	4	5
availability of completed sheets	0	0	0	0	7	5
	preferably paper-based		doesn't matter		preferably electronic
do you prefer a paper-based or electronic version?	0	0	0	0	7	5
referring physicians (n = 15)	very dissatisfied	dissatisfied	indifferent	satisfied	very satisfied
overall, how satisfied are you with the electronic version of the organ transplantation sheet?	0	1	2	5	7	4
	very poor	poor	no opinion	good	very good	median
clearness of completed sheets	0	1	2	6	6	4
availability of completed sheets	0	0	3	5	7	4
	preferably paper-based		doesn't matter		preferably electronic	median
do you prefer a paper-based or electronic version?	0	0	2	4	9	5

Discussion

The advantages of structured report templates have been documented many times in the literature [3]. Therefore, for example, it could be shown that the report text contains significantly more relevant information for referring physicians and the satisfaction of clinical partners is significantly higher as a result of the use of structured report templates [15]. Similar results are seen in relation to the staging of rectal cancer and the description of cerebral lesions in multiple sclerosis or pathological findings in the intestine in Crohn's disease [16] [17] [18]. Although some manufacturers offer proprietary solutions for structured reporting, there is a lack of support for the IHE-MRRT standard.

Therefore, it seems logical to create an IHE-MRRT-compliant electronic version of the report sheet to meet the requirements regarding the documentation of patients with HCC that were updated as part of the guideline amendment and thus also to demonstrate the practical feasibility on the basis of a current clinically relevant example. A corresponding template was able to be developed and used on a free and open-source reporting platform without difficulty. Corresponding to similar experiences in the literature, a high level of user satisfaction on the part of clinicians and radiologists could also be shown.

Some ambiguities in relation to individual sections of the report sheet published in the Ärzteblatt were identified during the study period, thus necessitating internal clarification. However, there is a risk that this lack of explanations developed together with clinical radiologists and published in advance in the report sheets created to date in Germany may have led to a certain level of heterogeneity.

In our case the following rules were defined in coordination with clinical colleagues to ensure uniform report quality and results without making a claim to their general validity:

Verification based solely on imaging (according to S3 guidelines) was permissible for the diagnosis of HCC, while liver cirrhosis required histological confirmation. Only verified HCC lesions should be evaluated and the same number of lesions as specified under "number of HCC nodules" should be displayed and documented. According to the guidelines, verified lesions were (analogous to Li-Rads, https://nrdr.acr.org/lirads/) lesions > 2 cm with typical contrast enhancement behavior (arterial hypervascularization with washout or lesions between 1 and 2 cm with typical behavior on two images). Lesions < 1 cm were not taken into consideration unless there was a definitive histological result for the lesion. Similar rules were also defined by the United Network for Organ Sharing in the United States in order to include only lesions that are HCC lesions with almost 100 % certainty in reports [12] [13]. A lesion previously defined as HCC-typical was still considered a lesion as defined by the guidelines following TACE (with only the vital part of the tumor being measured as in mRECIST [14]), while lesions treated on a curative basis (resection, local ablation) were no longer considered lesions.

Our results show that report templates corresponding to the IHE-MRRT profile allow a quick response to the increasing demands for structured and standardized reporting. Moreover, report templates make it possible to support radiologists with stored, explanatory notes and computer-based decision-making tools in order to achieve consistently high report quality.

In addition to the ideally higher report quality, report templates provide the further advantage that radiologists can help to establish a clinical database without additional effort as part of the daily routine. The stored information is readily accessible at any time and can thus be used with the patient's consent, for example, for clinical studies or for health services research ([Fig. 3]).

This study also clearly shows that structured reporting can have a concrete effect on the clinical routine today – and not in what seemed like the distant future several years ago [19].

No conflict of interest has been declared by the author(s).

• References

• 1 Richtlinien zur Organtransplantation gem. §16 TPG. Deutsches Ärzteblatt 2016; 26: 1-22
• 2 Hackländer T. Structured reporting in radiology. Radiologe 2013; 53: 613-617
• 3 Bosmans JML, Neri E, Ratib O. et al. Structured reporting: a fusion reactor hungry for fuel. Insights Imaging 2015; 6: 129-132
• 4 Faggioni L, Coppola F, Ferrari R. et al. Usage of structured reporting in radiological practice: results from an Italian online survey. Eur Radiol 2016; 27: 1934
• 5 Hanna TN, Shekhani H, Maddu K. et al. Structured report compliance: effect on audio dictation time, report length, and total radiologist study time. Emerg Radiol 2016; 23: 449-453
• 6 European Society of Radiology (ESR). Good practice for radiological reporting. Guidelines from the European Society of Radiology (ESR). Insights Imaging 2011; 2: 93-96
• 7 Morgan TA, Helibrun ME, Kahn Jr CE. Reporting Initiative of the Radiological Society of North America: Progress and New Directions. Radiology 2014; 273: 642-645
• 8 IHE Radiology Technical Committee. IHE Radiology Technical Framework Supplement Management of Radiology Report Templates (MRRT). 2016: 1-50
• 9 Kahn CE. Incorporating intelligence into structured radiology reports. In: Law MY, Cook TS. eds. Proceedings of SPIE: medical imaging 2014-PACS and imaging informat- ics: next generation and innovations. Vol 9039. Bellingham, Wash: SPIE–The International Society for Optical Engineering; 2014: 90390M
• 10 Pinto dos Santos D, Klos G, Kloeckner R. et al. Development of an IHE MRRT-compliant open-source web-based reporting platform. Eur Radiol Springer Berlin Heidelberg 2017; 27: 424-430
• 11 Likert R. A technique for the measurement of attitudes. Archives of Psychology 1932; 22: 55
• 12 Wald C, Russo MW, Heimbach JK. et al. New OPTN/UNOS Policy for Liver Transplant Allocation: Standardization of Liver Imaging, Diagnosis, Classification, and Reporting of Hepatocellular Carcinoma. Radiology 2013; 266: 376-382
• 13 Mitchell DG, Bruix J, Sherman M. et al. LI-RADS (Liver Imaging Reporting and Data System): Summary, discussion, and consensus of the LI-RADS Management Working Group and future directions. Hepatology 2014; 61: 1056-1065
• 14 Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis 2010; 30: 52-60
• 15 Brook OR, Brook A, Vollmer CM. et al. Structured Reporting of Multiphasic CT for Pancreatic Cancer: Potential Effect on Staging and Surgical Planning. Radiology 2015; 274: 464-472
• 16 Wildman-Tobriner B, Allen BC, Davis JT. et al. Structured Reporting of Magnetic Resonance Enterography for Pediatric Crohn's Disease: Effect on Key Feature Reporting and Subjective Assessment of Disease by Referring Physicians. Curr Probl Diagn Radiol 2017; 46: 110-114
• 17 Sahni VA, Silveira PC, Sainani NI. et al. Impact of a Structured Report Template on the Quality of MRI Reports for Rectal Cancer Staging. Am J Roentgenol American journal of roentgenology 2015; 205: 584-588
• 18 Dickerson E, Davenport MS, Syed F. et al. Effect of Template Reporting of Brain MRIs for Multiple Sclerosis on Report Thoroughness and Neurologist-Rated Quality: Results of a Prospective Quality Improvement Project. J Am Coll Radiol 2016; 14: 371-379
• 19 Hall FM. The radiology report of the future. Radiology 2009; 251: 313-316