Introduction
To continuously ensure improvement in the quality of oncological care, implementation of innovations is essential. The quality of oncological care is outlined within oncological clinical practice guidelines [
1,
2]; however, on population level, there is variation in adherence to these guidelines [
3‐
5], in particular considering the adoption of digital innovations. This situation could be improved by developing and evaluating implementation strategies [
6]. Recent studies highlighted the indispensability of properly conducted evaluation studies of multi-faceted and tailored strategies, to determine how to enhance the impact of implementation strategies [
7,
8]. These evaluation studies should properly examine the effect of the implemented strategy as well as the process of the implementation, to identify essential contributing factors to the success or failure of the strategy [
6].
Previous research confirmed the additional value of standardized structured reporting (SSR) use compared to other types of reporting, even improving patient outcomes for certain diagnoses [
9‐
11]. Therefore, national and international oncology guidelines advocate the use of SSR in diagnostic disciplines, such as pathology [
2,
12]. Over the past years, the SSR use has increased and the number of countries adopting the International Collaboration of Cancer Reporting templates is increasing as well [
13,
14]. However, differences in SSR usage are still present between countries and within countries between the reporting of tumor types, retrieval techniques, and (types of) laboratories, resulting in variation in treatment choices and therefore, patient outcomes [
13,
15‐
18]. From our previously conducted context analyses, we retrieved barriers and facilitators for SSR implementation [
19,
20].
A digitally free-offered implementation strategy, tailored to the previously found influencing factors, will have great promises for usability and practicality relative to in-person activities and even more so since the start of the COVID-19 crisis [
21]. However, evidence is lacking on effectiveness and feasibility of a complete digital implementation strategy, especially for an innovation such as SSR. Therefore, we first conducted a pilot, exploring our tailored strategy on increased use of SSR among pathology laboratories for the reporting of three common groups of tumors: gastrointestinal, gynecological, and urological cancers [
22]. To verify these pilot results, a large-scale national level assessment was necessary. The objective of the current study is therefore to determine effectiveness, feasibility, and combined effects of a promising multifaceted tailored implementation strategy, aimed at improving daily clinical practice at a national level. The specific objectives were as follows:
1)
To determine the effect of the implementation strategy on the change in level of proportion of SSR usage and the change in linear trend in SSR usage for the following:
a) All gastrointestinal, gynecological, and urological oncology pathology reporting
b) Pathology reporting per tumor group (gastrointestinal, gynecological, and urological)
c) Pathology reporting per retrieval method (biopsies and resections)
d) Pathology reporting per type of laboratory (non-academic and academic)
2)
To determine the change in the SSR use per pathology laboratory, also analyzed for the previously mentioned subgroups (b–d).
3)
To determine the feasibility of the implementation strategy by the following:
a) Determining the exposure to the different strategy elements
b) Determining the experiences of the users of the implementation strategies
c) Determining perceived barriers and improvements of SSR implementation
4)
To determine an effect and combined effect between use of implementation strategy elements by pathology laboratories and the change in level of proportion of SSR usage and the change in linear trend in SSR usage of these pathology laboratories after strategy introduction.
Discussion
We aimed to improve the national implementation of SSR, by disseminating and evaluating a fully digital multifaceted tailored implementation strategy in a real-life setting. We showed that this way improvements in guideline implementation can be achieved. Effect evaluation showed a significant improvement in SSR usage for reporting for gastrointestinal and urological tumors and reporting of resections. No change was seen for the overall reporting for our three tumor groups, gynecological reporting, and biopsy reporting. A difference between academic and non-academic laboratories was present. Descriptive results showed that 33 out of 42 pathology laboratories improved their SSR use after strategy introduction. Process evaluation results for self-reported effectiveness supported this outcome, but also illustrated the additional value of other strategy elements. Our digital elements were all accessible and usable. However, integration of elements within SSR templates would increase their use. Barriers of SSR implementation, most related to rigidity, time consumption, and content of SSR template or reports, were still experienced by most pathologists and pathology residents. Effectiveness results on specific strategy elements showed that the use of the “Feedback button” was most effective in increasing SSR. Combined effect analysis showed that the use of multiple active strategy elements (2 or 3) did not lead to a change in SSR use compared to using 1 or none active strategy.
From both the effect and parallel process evaluation, we can conclude that barriers still exist, in particular for certain subgroups of reports. The presence of these persisting barriers may also explain why the use of the evaluated implementation strategy elements was still suboptimal and no combined effect was found, although dissemination of the implementation strategy was improved by incorporation of insights from our pilot study [
22]. These barriers were earlier recognized [
19,
20], but due to lack of time and financial resources, we could not develop specific strategies to overcome these barriers [
22]. Overall, the pathology reporting for the three groups of tumors improved in the majority of the pathology laboratories, showing that small results in laboratories are possible, but the barriers for specific subgroups should be overcome to significantly improve SSR on a national level.
Our study showed the effectiveness and feasibility of a nationwide implementation of a digital innovation in pathology. This provides helpful insights to be used for other related implementation studies. Remaining barriers were rigidity of SSR templates and time needed to fill in a pathology report, already known from previous studies [
19,
38,
39] and supported by the fact particularly for biopsies increase in SSR use remains relatively low. In addition, pathologists would prefer integrated implementation strategy elements. As increasingly pathology laboratories shift toward a fully digital workflow, requirements for IT development should be focused on efficient, user-friendly digital pathology workflows. For example, the use of computational pathology algorithms can potentially fill in SSR templates for biopsies, decreasing the time needed for the pathologist to fill out the SSR template. Other implementation strategy elements, such as the e-learning and audit & feedback reports, might be expanded to support the entire workflow of pathologists. Both elements could be taken up by (inter) national associations [
40].
Instead of randomly choosing implementation strategy elements, we selected and developed our multifaceted implementation strategy to barriers and facilitators determined in previous studies and tested it in a small-scale setting before nationwide implementation [
19,
20,
22]. Using this scientific implementation method, we were able to evaluate 6 different implementation strategy elements. However, due to organizational and technical issues, we could not test all promising strategy elements, which is one of the limitations of our study. This might explain differences in the SSR uptake between tumor groups. First, widely accepted SSR template content would benefit SSR use. By the end of the post introduction period, the first SSR template developed together with the pathology expertise group was published, setting an example for further development and improvement of other SSR templates. After establishment of a standardized governance structure on SSR development and improvement, this strategy could be evaluated, as other regions and countries implementing SSR are struggling with this as well [
41]. Second, several improvements in technical aspects of the SSR template software were not developed, hampered by software design capabilities and the lack of ability to exchange discrete data with for example the hospital information system. Additionally, in case of local technical issues, having a PALGA liaison and clear communication protocols did not seem sufficient. Since pathology laboratories increasingly adopt a digital workflow, this requires dedicated staff on both a national and local level, controlling both pathology and information technology knowledge, skills, and experiences, providing pathologists with the technical assistance they need.
Strengths and limitations
First of all, our study showed the importance of improving guideline implementation in diagnostics at a national level. Implementation decreases the variation, resulting in more standardization of diagnosis and treatment, ultimately benefiting patients. Second, in times of social distancing and also working extensively from home during the COVID-19 pandemic, our study showed that a fully digital implementation strategy facilitates continuing improvement of the implementation of a guideline recommendation. Third, international researchers and health policy makers could use our study as an example for other guideline recommendations with various adoption levels in clinical practice, for which data is already collected on a national level to be analyzed and is ready to be used to improve clinical practice. Last, by first conducting a pilot test, both the dissemination and implementation strategy were already adapted to pathologists’ needs, before scaling up to a national level.
This study also had some limitations. Relatively few research resources (both time and monetary) are available for implementation studies, resulting in a continuous circle of settling for quick and easy solutions. This does not only lower the effect of implementation studies itself, but also hampers progress in implementation science. However, we still managed to gain an effect for some subgroups of reporting by the dissemination of our implementation strategy in its current composition. Another limitation concerns the low response rate to the eSurvey, resulting in less generalizable process outcomes on experiences. However, we still gathered fruitful insights into the implementation process. A last limitation is that we could not determine the effect of all different elements on SSR usage and we could not adjust for laboratory characteristics in the combined effect analysis, since this information was unavailable. Differences between academic non-academic laboratories suggested that laboratory characteristic influence the use of strategic elements. The academic laboratories showed a decrease in SSR after induction of the implementation strategy and relatively frequent used the eLearning. This might have biased the effects of eLearning on SSR use. In addition, SSR usage was measured during the COVID-19 pandemic, in which a decline in oncology diagnoses was reported [
42]. However, all measurements were conducted during this period (June 2020–November 2021) and by using a digital accessible implementations strategy, pathologists, pathology residents, and PALGA liaisons were still able to participate in this study.
Conclusion
Nationwide SSR implementation for pathology reporting of gastrointestinal and urological cancers was improved by the implementation of a diverse pallet of digitally available implementation strategy elements, free to use for pathologists to increase their use of SSR. For other subgroups, such as the reporting of biopsies and gynecological oncology, specific barriers are known from previous analyses and these are still hampering the implementation of SSR. Since SSR, without being mandatory, is already very frequently used in pathology practice, in coming years the focus should be on how to overcome remaining barriers of SSR use in clinical practice. Moreover, now is the time for stakeholders, such as pathologists, pathology associations, pathology and cancer registries, IT, and patient associations, to closely work together to also achieve the potential benefits of SSR use by pathologists. In addition, since pathology is world leader in SSR implementation, but lags behind in other digital transitions, close collaboration with other disciplines remains on the agenda the next years, to achieve an optimal oncological diagnostic workflow. This will result in pipelines containing structured and standardized data for all diagnostic disciplines involved in oncology care, enabling improved treatment decisions.
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