Lidington Emma, Hogan Holly, Gandolfi Ann, Lawrence Jane, Younger Eugenie, Cho Helena, Peckitt Clare, Mohammed Kabir, Matharu Sheila, Scerri Lisa, Husson Olga, Cruickshank Susanne, Turner Rachel, Wedlake Linda
PROFILES Team, The Royal Marsden NHS Foundation Trust, London, UK.
Research & Development, The Royal Marsden NHS Foundation Trust, London, UK.
J Patient Rep Outcomes. 2022 Dec 22;6(1):128. doi: 10.1186/s41687-022-00529-9.
To understand our performance with respect to the collection and reporting of patient-reported outcome (PRO) measure (PROM) data, we examined the protocol content, data completeness and publication of PROs from interventional trials conducted at the Royal Marsden NHS Foundation Trust (RM) and explored factors associated with data missingness and PRO publication.
From local records, we identified closed, intervention trials sponsored by RM that opened after 1995 and collected PROMs as primary, secondary or exploratory outcomes. Protocol data were extracted by two researchers and scored against the SPIRIT-PRO (PRO protocol content checklist; score 0-100, higher scores indicate better completeness). For studies with locally held datasets, the information team summarized for each study, PRO completion defined as the number of expected (as per protocol) PRO measurements versus the number of actual (i.e. completed) PRO measurements captured in the study data set. Relevant publications were identified by searching three online databases and chief investigator request. Data were extracted and each publication scored against the CONSORT-PRO (PRO manuscript content checklist; scored as SPIRIT-PRO above). Descriptive statistics are presented with exploratory comparisons of point estimates and 95% confidence intervals.
Twenty-six of 65 studies were included in the review. Nineteen studies had accessible datasets and 18 studies published at least one article. Fourteen studies published PRO results. Most studies had a clinical (rather than PRO) primary outcome (16/26). Across all studies, responses in respect of 35 of 69 PROMs were published. Trial protocols scored on average 46.7 (range 7.1-92.9) on the SPIRIT-PRO. Among studies with accessible data, half (10/19) had less than 25% missing measurements. Publications scored on average 80.9 (range 36-100%) on the CONSORT-PRO. Studies that published PRO results had somewhat fewer missing measurements (19% [7-32%] vs 60% [- 26 to 146%]). For individual PROMs within studies, missing measurements were lower for those that were published (17% [10-24%] vs 41% [18-63%]). Studies with higher SPIRIT-PRO scores and PROs as primary endpoints (13% [4-22%] vs 39% [10-58%]) had fewer missing measurements.
Missing data may affect publication of PROs. Extent of inclusion of SPIRIT-PRO protocol items and PROs as primary endpoints may improve data completeness. Preliminary evidence from the study suggests a future larger study examining the relationship between PRO completion and publication is warranted.
为了解我们在收集和报告患者报告结局（PRO）测量指标（PROM）数据方面的表现，我们检查了皇家马斯登国民保健服务基金会信托基金（RM）开展的干预性试验的方案内容、数据完整性以及PRO的发表情况，并探讨了与数据缺失及PRO发表相关的因素。
我们从本地记录中识别出1995年后开放、由RM赞助且将PROM作为主要、次要或探索性结局进行收集的已结束干预性试验。两名研究人员提取方案数据，并根据SPIRIT-PRO（PRO方案内容清单；评分0-100，分数越高表明完整性越好）进行评分。对于拥有本地数据集的研究，信息团队为每项研究进行总结，PRO完成情况定义为预期（根据方案）的PRO测量次数与研究数据集中实际（即已完成）捕获的PRO测量次数之比。通过搜索三个在线数据库和向首席研究员请求来识别相关出版物。提取数据，并根据CONSORT-PRO（PRO稿件内容清单；评分方式与上述SPIRIT-PRO相同）对每篇出版物进行评分。呈现描述性统计数据，并对点估计值和95%置信区间进行探索性比较。
65项研究中有26项纳入综述。19项研究有可获取的数据集，18项研究发表了至少一篇文章。14项研究发表了PRO结果。大多数研究的主要结局是临床结局（而非PRO结局）（16/26）。在所有研究中，69项PROM中有35项的结果得以发表。试验方案在SPIRIT-PRO上的平均得分为46.7（范围7.1-92.9）。在有可获取数据的研究中，一半（10/19）的研究测量值缺失率低于25%。出版物在CONSORT-PRO上的平均得分为80.9（范围36-100%）。发表PRO结果的研究测量值缺失情况略少（19% [7-32%] 对比60% [-26至146%]）。对于研究中的单个PROM，已发表的测量值缺失率较低（17% [10-24%] 对比41% [18-63%]）。SPIRIT-PRO得分较高且将PRO作为主要终点的研究（13% [4-22%] 对比39% [10-58%]）测量值缺失较少。
数据缺失可能会影响PRO的发表。SPIRIT-PRO方案项目的纳入程度以及将PRO作为主要终点可能会提高数据完整性。该研究的初步证据表明，有必要开展一项未来规模更大的研究来考察PRO完成情况与发表之间的关系。
