In the diagnostic pathway for early detection of prostate cancer, MRI, biopsies, and pathology are included. The shift towards ‘MRI first’ avoids unnecessary biopsies and reduces overdiagnosis [1] but demands high standards for Prostate Imaging-Reporting and Data System (PI-RADS) [2] grading and accuracy in targeted biopsies. Formulating a comprehensive assessment for optimal patient management is challenging for today's urologists as the volume and complexity of data grow. Quality registers are crucial for evaluating, comparing, and improving patient care. The Swedish National Prostate Cancer Register (NPCR) encompasses over 240 000 patients and is routinely used to monitor and evaluate care quality, aiming to optimise patient outcomes through transparent comparisons [3].

Traditionally, reporting to quality registries relies on manual post-registration, which has disadvantages including time consumption, registration errors, and incomplete data. A multi-professional group within the Swedish NPCR developed a nationally endorsed novel model for integrated prostate cancer diagnostics, tested in routine care in autumn 2023. The model (Figs 1, S1 and S2) is based on ‘single entry’ per specialist and comprises six key components: complete data registration, real-time data registration, structured MRI and pathology review and reporting, structured biopsy sampling and referral, individualised automated feedback from biopsy to radiologist, and summarised outcomes from MRI, biopsy, and pathology in an interactive format.

The workgroup included urologists, radiologists, pathologist, urology nurse, patient representative, product owner from the Swedish Information Network for Cancer (INCA), and a project manager. The model was evaluated by a national reference group that included key opinion leaders holding leadership positions for the National Clinical Care guidelines for prostate cancer and the organised prostate cancer testing from urology, pathology, and radiology. Data management occurs within the Swedish INCA, with designated personnel ensuring adaptation to a national model with modular data collection for quality registries and structured frameworks within collaborative groups. The system ensures vendor neutrality and compatibility with various data sources.

The model serves as a tool for structured MRI prostate review and reporting based on PI-RADS version 2.1. Radiologists can register directly in the MRI template on the Swedish INCA database or follow their standard clinical workflow in a Picture Archiving and Communication System (PACS) mirrored with the Swedish INCA (Sectra PACS was used in the pilot study, Sectra AB, Linköping, Sweden). A structured report is automatically generated as data are entered into the MRI template. Prostate volume calculation to obtain PSA density is mandatory. For focal lesions, zone, sector, size, and PI-RADS scoring are mandatory fields. The correct zone and sector are automatically generated when the radiologist outlines the lesion in a biopsy template, serving as foundational information for the urologist in subsequent biopsy procedures. For PI-RADS ≥4, grading of extraprostatic extension and seminal vesicle invasion is mandatory, as well as evaluation of potential metastatic lesions in lymph nodes or bone marrow. Data registered in the PACS system are transferred and registered in the MRI template on the Swedish INCA when approved by the radiologist. Feedback from biopsy outcomes can be accessed through the Swedish INCA or automated feedback in a dynamic worklist in the local PACS system.

The urologist records the localisation and number of biopsies in the Swedish INCA template pre-filled with MR lesions, ensuring targeted biopsies are registered correctly. Information regarding transrectal or transperineal biopsy approach and whether biopsies are cognitive or software-assisted is noted. For transperineal biopsies, multiple sectors in the vertical dimension can be registered on the same biopsy. A structured referral to the pathologist is generated in real-time as registrations are made.

The pathologist records data in the Swedish INCA template pre-filled with MRI and biopsy information, resulting in a structured report. For each biopsy, sector(s) and biopsy length are registered. For adenocarcinoma, Gleason grade is selected from a drop-down menu, and if Gleason 7 is recorded, percentage Grade 4 and potential presence of a cribriform pattern are mandatory. A suggestion for the global Gleason score and an International Society of Urological Pathology (ISUP) grade for each lesion is automatically generated. Total cancer length and biopsy length are calculated for systemic biopsies. Invasion (i.e., perineural, vascular) is registered when present. The structured report is auto-populated and can be duplicated to the pathologist's local Laboratory Information System.

After these steps, a synoptic summary of the diagnostic pathway is available with complex information presented clearly and interactively. Lesion localisation and PI-RADS score, number and type of biopsies, and outcomes are summarised, functioning as referral response to the urologist and feedback to the radiologist. The overview can be used during patient meetings or in multidisciplinary conferences to quickly summarise complex information.

This novel model was tested at the urology clinic in Helsingborg over 3 months in autumn 2023. In all, 98 patients underwent biopsies, with all pathway steps verified and monitored. User experiences were collected through surveys, and data transfer between systems and the Swedish INCA was monitored. The pilot study showed effective data flow between pathway components, from radiologist's registration in the local PACS to biopsy referrals, pathology referral responses, and automated feedback to radiologists regarding biopsy outcomes.

Surveys indicated high satisfaction among users. The global rating for using the templates was 8.5/10 among 14 urologists, 9.5/10 among eight radiologists, and 9/10 among five pathologists. Feedback of biopsy outcomes to radiologists was highly appreciated (10/10). Documentation in templates was considered time-saving by radiologists (5 min shorter per case) and pathologists, though urologists experienced a 3-min increase per case. Urologists were pleased with the biopsy template functioning as a pathology referral (8/10).

Using the model requires only one registration per specialist, ensuring complete and accurate data for the quality register. Evaluation can be done nationally, regionally, and at the clinic and individual levels. The pilot study found that the model is highly appreciated by radiologists, urologists, and pathologists.

The model addresses three challenges in MRI prostate diagnostics: the importance of structured review and reporting, and radiologists learning from biopsy feedback [4]. The solution with automated feedback is unique, based on integration between quality registers and PACS. ‘MRI first’ relies on adequate PI-RADS scoring, and challenges with inter-reader variation are well known [5]; hence, the feedback loop in our model is expected to reduce false-positive MRIs.

For urologists, the model's greatest benefit is a concise summary of all relevant information from the integrated pathway. Additionally, biopsy templates provide an automatically generated structured referral to pathology. Narrative free-text reports are still common in pathology and radiology, making complex information communication challenging. The model provides pathologists with a structured review roadmap and results in a structured report, used as feedback to urologists and radiologists. The workflow is time-saving for radiologists and pathologists, and synoptic templates are advantageous [6]. Consolidated information was well received as feedback to radiologists and had added value in multidisciplinary conferences.

A positive outcome is the model's use in organised prostate cancer testing in several large health regions, offering unique quality monitoring and evaluation opportunities [7]. After the pilot study's positive outcomes, the model is being implemented in a health region with 1.4 million inhabitants in southern Sweden. A sustainable, long-term plan for resource allocation, communication, training, and support functions is in place to ensure successful implementation. Once implemented, the model will provide opportunities for validating a wide range of diagnostic and therapeutic metrics. Ongoing efforts include continuous refinement, such as incorporating prostate-specific membrane antigen positron emission tomography/CT data and output from radical prostatectomies.

In summary, we present a novel, nationally accepted model, integrated into clinical practice, to enhance the precision and quality assessment of prostate cancer diagnostics. The model's structure and design can be generalised to other diagnoses where quality assessments of integrated diagnostic pathways are of interest.

在前列腺癌早期检测的诊断途径中，包括 MRI、活检和病理学。向“MRI 优先”的转变避免了不必要的活检，减少了过度诊断 [1]，但对前列腺成像报告和数据系统 （PI-RADS） [2] 分级和靶向活检的准确性提出了高标准要求。随着数据量和复杂性的增长，对于当今的泌尿科医生来说，制定全面的评估以实现最佳患者管理是一项挑战。质量登记册对于评估、比较和改善患者护理至关重要。瑞典国家前列腺癌登记处 （NPCR） 涵盖超过 240 000 名患者，通常用于监测和评估护理质量，旨在通过透明的比较来优化患者的预后 [3]。

传统上，向质量注册机构报告依赖于手动后注册，其缺点包括耗时、注册错误和数据不完整。瑞典 NPCR 内的一个多专业小组开发了一种国家认可的综合前列腺癌诊断新模型，并于 2023 年秋季在常规护理中进行了测试。该模型（图 1、S1 和 S2）基于每位专家的“单次输入”，包括六个关键组成部分：完整的数据配准、实时数据配准、结构化 MRI 和病理学审查和报告、结构化活检取样和转诊、从活检到放射科医生的个性化自动反馈，以及以交互式格式总结 MRI、活检和病理学的结果。

该工作组包括泌尿科医生、放射科医生、病理学家、泌尿外科护士、患者代表、瑞典癌症信息网络 （INCA） 的产品负责人和一名项目经理。该模型由一个国家参考小组进行评估，该小组包括担任国家前列腺癌临床护理指南领导职务的关键意见领袖，以及泌尿学、病理学和放射学的有组织的前列腺癌检测。数据管理在瑞典 INCA 内部进行，指定人员确保适应国家模式，为质量登记和协作小组内的结构化框架进行模块化数据收集。该系统确保供应商中立性以及与各种数据源的兼容性。

该模型用作基于 PI-RADS 2.1 版的结构化 MRI 前列腺审查和报告工具。放射科医生可以直接在瑞典 INCA 数据库的 MRI 模板中注册，也可以在与瑞典 INCA 镜像的图片存档和通信系统 （PACS） 中遵循他们的标准临床工作流程（Sectra PACS 用于瑞典林雪平 Sectra AB 的试点研究）。将数据输入到 MRI 模板中时，会自动生成结构化报告。为了获得 PSA 密度，必须计算前列腺体积。对于局灶性病变，区域、扇区、大小和 PI-RADS 评分是必填字段。当放射科医生在活检模板中勾勒出病变时，会自动生成正确的区域和扇区，作为泌尿科医生在后续活检程序中的基础信息。对于 PI-RADS ≥4，必须对前列腺外扩展和精囊浸润进行分级，并评估淋巴结或骨髓中的潜在转移病灶。经放射科医生批准，在 PACS 系统中注册的数据将被传输并注册在瑞典 INCA 的 MRI 模板中。活检结果的反馈可以通过瑞典 INCA 访问，也可以在本地 PACS 系统的动态工作列表中获得自动反馈。

泌尿科医生在预装 MR 病灶的瑞典 INCA 模板中记录活检的位置和数量，确保正确配准目标活检。记录有关经直肠或经会阴活检方法的信息，以及活检是认知活检还是软件辅助活检。对于经会阴活检，可以在同一活检中记录垂直维度的多个扇区。在进行注册时，会实时生成对病理学家的结构化转诊。

病理学家在瑞典 INCA 模板中记录数据，该模板预先填充了 MRI 和活检信息，从而生成结构化报告。对于每次活检，都会记录扇区和活检长度。对于腺癌，从下拉菜单中选择 Gleason 分级，如果记录了 Gleason 7，则必须提供 4 级百分比和可能存在筛状模式。系统会自动为每个病灶生成全球 Gleason 评分和国际泌尿病理学会 （ISUP） 分级的建议。计算全身活检的癌症总长度和活检长度。侵袭 （即神经周围、血管） 在存在时被记录下来。结构化报告是自动填充的，可以复制到病理学家的本地实验室信息系统中。

在这些步骤之后，可以获得诊断途径的概要摘要，其中的复杂信息清晰且交互式地呈现。总结了病变定位和 PI-RADS 评分、活检的数量和类型以及结果，作为对泌尿科医生的转诊反应和对放射科医生的反馈。该概览可用于患者会议或多学科会议，以快速总结复杂信息。

这种新颖的模型于 2023 年秋季在赫尔辛堡的泌尿外科诊所进行了为期 3 个月的测试。总共 98 例患者接受了活检，验证和监测了所有通路步骤。通过调查收集用户体验，并监控系统与瑞典 INCA 之间的数据传输。试点研究表明，从放射科医生在当地 PACS 中的注册到活检转诊、病理学转诊反应以及向放射科医生提供有关活检结果的自动反馈，通路组成部分之间的有效数据流。

调查显示用户满意度很高。使用模板的全球评分在 14 名泌尿科医生中为 8.5/10，在 8 名放射科医生中为 9.5/10，在 5 名病理学家中为 9/10。向放射科医生反馈活检结果受到高度赞赏 （10/10）。放射科医生（每个病例缩短 5 分钟）和病理学家认为模板中的文档可以节省时间，尽管泌尿科医生每个病例增加了 3 分钟。泌尿科医生对活检模板作为病理转诊的功能感到满意 （8/10）。

使用该模型只需每位专家进行一次注册，即可确保质量登记数据完整准确。评估可以在国家、区域以及诊所和个人层面进行。试点研究发现，该模型受到放射科医生、泌尿科医生和病理学家的高度赞赏。

该模型解决了 MRI 前列腺诊断中的三个挑战：结构化审查和报告的重要性，以及放射科医生从活检反馈中学习 [4]。具有自动反馈功能的解决方案是独一无二的，它基于质量寄存器和 PACS 之间的集成。“MRI 优先”依赖于适当的 PI-RADS 评分，读者间差异的挑战是众所周知的 [5];因此，我们模型中的反馈回路有望减少假阳性 MRI。

对于泌尿科医生来说，该模型的最大好处是简明扼要地总结了来自综合途径的所有相关信息。此外，活检模板提供自动生成的结构化病理转诊。叙述性自由文本报告在病理学和放射学中仍然很常见，这使得复杂的信息通信具有挑战性。该模型为病理学家提供结构化的审查路线图，并生成结构化报告，用作泌尿科医生和放射科医生的反馈。该工作流程为放射科医生和病理学家节省时间，并且概要模板是有利的 [6]。整合的信息作为对放射科医生的反馈而受到好评，并在多学科会议中具有附加价值。

一个积极的结果是该模型在几个大型卫生地区的有组织的前列腺癌检测中使用，提供了独特的质量监测和评估机会 [7]。在试点研究取得积极成果后，该模型正在瑞典南部一个拥有 140 万居民的卫生区域实施。为确保成功实施，制定了针对资源分配、沟通、培训和支持职能的可持续长期计划。一旦实施，该模型将为验证广泛的诊断和治疗指标提供机会。正在进行的工作包括持续改进，例如纳入前列腺特异性膜抗原正电子发射断层扫描/CT 数据和根治性前列腺切除术的输出。

总之，我们提出了一种新颖的、全国公认的模型，并将其整合到临床实践中，以提高前列腺癌诊断的精度和质量评估。该模型的结构和设计可以推广到对综合诊断途径的质量评估感兴趣的其他诊断。