数据收集报告(DCR)

数据收集报告（DCR）是临床评价过程中的一个关键文档，它系统地记录并总结了按照预定方案（通常是临床评价计划CEP中的文献检索计划LSP）执行数据检索活动的详细过程和直接产出。这份报告的核心目的是为后续的数据评估、分析以及最终临床评价报告（CER）的撰写，提供一个透明、可追溯、可审核的原始数据收集结果清单。

一份结构清晰、内容详实的DCR，通常会围绕以下几个核心方面展开。

1. DCR的目的、范围及基础信息

首先应明确阐述本DCR的目的与范围。包括清晰说明本报告旨在记录针对特定待评价医疗器械（应在此处简要列出器械的关键识别信息，如通用名称、预期用途、适应症、目标患者人群等）的安全性与性能评价，而进行的相关公开数据（主要来自科学临床文献和安全数据库）的收集、筛选和初步评估过程及其结果。应明确指出本次数据收集活动是严格依据先前在临床评价计划（CEP）中制定的文献检索计划（LSP）来执行的，从而确立DCR与整体临床评价策略的一致性。

2. 检索的数据库、时间范围及任何计划偏离

DCR需详尽记录实际检索的数据库名称及其设定的检索时间段。这应分别列出用于检索科学临床文献的数据库（例如PubMed, Embase等）和用于检索安全性信息（如不良事件、召回等）的数据库（例如FDA MAUDE, 各国药监局数据库如Swissmedic, BfArM, MHRA, TGA等）。对于不同类型的检索（如SOTA检索、特定器械检索），其设定的时间跨度（例如，SOTA检索可能限定为近五年，而安全数据库检索可能无时间限制以捕获所有相关事件）及其理由（例如，技术的快速发展或全面捕获安全事件的需求）均应清晰说明。

为确保透明度和可审核性，任何在实际执行过程中对原文献检索计划（LSP）的偏离情况及其理由，都必须在本报告中明确记录。若无偏离，则应明确声明。

3. 检索与筛选标准的确认

尽管详细的检索词表和纳入/排除标准已在LSP中制定，DCR中通常会再次确认或简要重述在实际筛选过程中严格应用的核心纳入与排除标准。这有助于读者理解文献筛选的依据，例如，是否仅纳入同行评审的已发表研究、特定语言（如英语）、以及是否排除体外研究、动物实验、会议摘要、综述评论等。

4. 数据初步评估方法的简述

DCR还需简要回顾在数据筛选和初步整理阶段所采用的数据评估方法。可能包括用于评估文献与待评价器械及研究问题相关性的标准（例如，通过打分体系评估器械的匹配度、应用的匹配度、患者群体的匹配度、报告质量等），以及用于初步判断文献科学质量的标准。应说明这些评估标准是如何被一致地应用于所有被识别的文献的，以及任何预设的纳入阈值（例如，相关性评分达到某一分值以上才被纳入进一步分析）。

5. 文献检索的量化结果呈现

这是DCR的核心内容之一，即科学文献检索的具体执行结果。此部分应以清晰、结构化的方式呈现：

• 各数据库的检索详情： 针对每个检索的数据库，列出实际使用的完整检索式（search strings）以及通过该检索式获得的原始文献数量。
• 筛选流程总结： 汇总所有数据库检索到的文献总数，在去除重复文献后的数量，以及经过标题/摘要初筛和全文复筛后，最终被纳入和排除的文献数量。强烈推荐使用PRISMA流程图或类似的图表形式，直观展示从最初检索到最终纳入文献的完整筛选路径，包括在每个阶段因何种主要原因排除了多少文献。

6. 纳入文献的初步评估结果与数据提取概要

对于通过筛选并被初步判定为相关的文献，DCR需要展示其初步评估的结果。逐篇列出纳入文献的基本信息（如引文格式），并附上其在相关性评估和科学质量初步评估中的得分或评级，以及最终是否被确认纳入深入分析的决定。

DCR应概述从这些最终纳入的文献中提取关键数据的情况。这部分旨在展示已从每篇重要文献中提取了哪些与器械安全性、性能、研究设计、患者特征等相关的信息。通常也会采用结构化表格，针对每篇文献列出提取的关键数据点（例如，患者/受试者数量、临床安全结果、临床性能结果、研究设计、器械型号、研究地点、局限性、证据等级等）。

7. 排除文献清单

为确保筛选过程的完整性和透明度，DCR需要附上一份清单，列出经过全文阅读后被最终排除的文献及其明确的排除理由。

8. 安全数据库检索结果

最后，DCR还需专门呈现从各类安全数据库中检索到的结果。列出所检索的每个安全数据库的名称、检索日期、执行的具体查询条件（如器械名称、报告日期范围等），以及检索到的相关条目数量。如果检索到了具体的不良事件报告、召回信息等，可能还需要对这些信息进行初步的归类和总结。

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A Data Collection Report (DCR) is a key document in the clinical evaluation process. It systematically records and summarizes the detailed procedures and direct outputs of data retrieval activities, particularly those executed according to a predefined protocol (the Literature Search Protocol (LSP) referenced in the Clinical Evaluation Plan (CEP)). The core purpose of this report is to provide a transparent, traceable, and auditable list of the original data collection results, which will then serve as the basis for subsequent data appraisal, analysis, and the compilation of the final Clinical Evaluation Report (CER).

A well-structured and comprehensive DCR typically unfolds around the following core aspects.

1. Purpose, Scope, and Foundational Information of the DCR

The introductory part of the report should first clearly articulate the Purpose and Scope of this DCR. This includes a clear statement that the report aims to document the collection, screening, and initial assessment process and results of relevant public data (primarily from scientific clinical literature and safety databases) for the evaluation of the safety and performance of the specific medical device(s) under evaluation (key identifying information for the device, such as its generic name, intended use, indications, target patient population, etc., should be briefly listed here). It should be explicitly stated that this data collection activity was conducted in strict accordance with the Literature Search Protocol (LSP) previously established in the Clinical Evaluation Plan (CEP), thereby establishing the DCR’s consistency with the overall clinical evaluation strategy.

2. Databases Searched, Time Periods, and Any Deviations from Plan

The DCR must meticulously document the names of the databases actually searched and the search periods applied. This should separately list the databases used for retrieving scientific clinical literature (e.g., PubMed, Embase) and those used for retrieving safety information (e.g., adverse events, recalls, such as FDA MAUDE, national competent authority databases like Swissmedic, BfArM, MHRA, TGA). For different types of searches (e.g., SOTA search, device-specific search), the timeframes covered (e.g., SOTA search might be limited to the last five years, while safety database searches might have no date limit to capture all relevant events) and the rationale for these timeframes (e.g., rapid technological development or the need to comprehensively capture safety events) should be clearly stated.

To ensure transparency and auditability, any deviations from the original Literature Search Protocol (LSP) that occurred during actual execution, along with their justifications, must be explicitly recorded in this report. If there were no deviations, this should be clearly stated.

3. Confirmation of Search and Screening Criteria

Although the detailed list of search terms and inclusion/exclusion criteria would have been established in the LSP, the DCR often reaffirms or briefly restates the core inclusion and exclusion criteria that were strictly applied during the actual screening process. This helps the reader understand the basis for literature selection, for example, whether only peer-reviewed published studies were included, specific languages (e.g., English), and whether in-vitro studies, animal experiments, conference abstracts, review articles, etc., were excluded.

4. Brief Outline of Data Appraisal Methodology Applied

The DCR also needs to briefly review the data appraisal methods employed during the data screening and initial organization phase. This might include the criteria used to assess the relevance of literature to the device under evaluation and the research questions (e.g., using a scoring system to evaluate device match, application match, patient group match, report quality), as well as criteria for an initial judgment of the scientific quality of the literature. It should be stated how these appraisal criteria were consistently applied to all identified literature and any pre-set inclusion thresholds (e.g., only articles with a relevance score above a certain value were included for further analysis).

5. Presentation of Quantitative Results of the Literature Search

This is one of the core components of the DCR, presenting the specific execution results of the scientific literature search. This section should present, in a clear and structured manner:

• Search Details for Each Database: For each searched database, list the complete search strings actually used and the number of raw publications retrieved with that string.
• Summary of the Screening Process: Aggregate the total number of publications retrieved from all databases, the number remaining after removing duplicates, and the number of publications included and excluded after title/abstract screening and full-text review. It is highly recommended to use a PRISMA flowchart or a similar diagrammatic representation to intuitively display the complete screening pathway from initial search to final inclusion of literature, including the main reasons for excluding articles at each significant stage.

6. Results of Initial Appraisal of Included Literature and Data Extraction Summary

For literature that passed the screening and was initially deemed relevant, the DCR needs to display the results of its initial appraisal. Listing each included publication’s basic information (e.g., citation) along with its assigned scores or ratings from the relevance assessment and preliminary scientific quality appraisal, as well as the final decision on whether it was confirmed for in-depth analysis.

The DCR should outline the extraction of key data from these finally included publications. This section aims to show what information relevant to device safety, performance, study design, patient characteristics, etc., has been extracted from each important publication. A structured table is also typically used here, listing key data points extracted for each publication (e.g., number of patients/subjects, clinical safety outcomes, clinical performance outcomes, study design, device model used, study location, limitations, evidence level).

7. List of Excluded Articles

To ensure the completeness and transparency of the screening process, a DCR typically includes a list of articles that were excluded after full-text review, along with clear reasons for their exclusion.

8. Results from Safety Database Searches

Finally, the DCR must also specifically present the results retrieved from various safety databases. This part should clearly list the name of each safety database searched, the search date, the specific query parameters executed (e.g., device name, report date range), and the number of relevant items found. If specific adverse event reports, recall notices, etc., were retrieved, a preliminary categorization and summary of this information might also be required.