School of Public Health and Management, Chongqing Medical University, Chonqqing, China.
State Key Laboratory of Ultrasound in Medicine and Engineering, College of Biomedical Engineering, Chongqing Medical University, Chongqing, China.
J Med Internet Res. 2021 Nov 9;23(11):e28915. doi: 10.2196/28915.
High-frequency patient-reported outcome (PRO) assessments are used to measure patients' symptoms after surgery for surgical research; however, the quality of those longitudinal PRO data has seldom been discussed.
The aim of this study was to determine data quality-influencing factors and to profile error trajectories of data longitudinally collected via paper-and-pencil (P&P) or web-based assessment (electronic PRO [ePRO]) after thoracic surgery.
We extracted longitudinal PRO data with 678 patients scheduled for lung surgery from an observational study (n=512) and a randomized clinical trial (n=166) on the evaluation of different perioperative care strategies. PROs were assessed by the MD Anderson Symptom Inventory Lung Cancer Module and single-item Quality of Life Scale before surgery and then daily after surgery until discharge or up to 14 days of hospitalization. Patient compliance and data error were identified and compared between P&P and ePRO. Generalized estimating equations model and 2-piecewise model were used to describe trajectories of error incidence over time and to identify the risk factors.
Among 678 patients, 629 with at least 2 PRO assessments, 440 completed 3347 P&P assessments and 189 completed 1291 ePRO assessments. In total, 49.4% of patients had at least one error, including (1) missing items (64.69%, 1070/1654), (2) modifications without signatures (27.99%, 463/1654), (3) selection of multiple options (3.02%, 50/1654), (4) missing patient signatures (2.54%, 42/1654), (5) missing researcher signatures (1.45%, 24/1654), and (6) missing completion dates (0.30%, 5/1654). Patients who completed ePRO had fewer errors than those who completed P&P assessments (ePRO: 30.2% [57/189] vs. P&P: 57.7% [254/440]; P<.001). Compared with ePRO patients, those using P&P were older, less educated, and sicker. Common risk factors of having errors were a lower education level (P&P: odds ratio [OR] 1.39, 95% CI 1.20-1.62; P<.001; ePRO: OR 1.82, 95% CI 1.22-2.72; P=.003), treated in a provincial hospital (P&P: OR 3.34, 95% CI 2.10-5.33; P<.001; ePRO: OR 4.73, 95% CI 2.18-10.25; P<.001), and with severe disease (P&P: OR 1.63, 95% CI 1.33-1.99; P<.001; ePRO: OR 2.70, 95% CI 1.53-4.75; P<.001). Errors peaked on postoperative day (POD) 1 for P&P, and on POD 2 for ePRO.
It is possible to improve data quality of longitudinally collected PRO through ePRO, compared with P&P. However, ePRO-related sampling bias needs to be considered when designing clinical research using longitudinal PROs as major outcomes.
高频患者报告结局（PRO）评估用于测量手术后患者的症状，用于外科研究；然而，这些纵向 PRO 数据的质量很少被讨论。
本研究旨在确定影响数据质量的因素，并描述通过纸质或基于网络的评估（电子 PRO[ePRO]）纵向采集的胸部手术后 PRO 数据的误差轨迹。
我们从一项关于不同围手术期护理策略评估的观察性研究（n=512）和一项随机临床试验（n=166）中提取了 678 例计划接受肺手术的患者的纵向 PRO 数据。在手术前使用 MD Anderson 症状量表肺癌模块和单一生活质量量表进行 PRO 评估，然后在手术后每天评估，直到出院或住院 14 天。比较纸质和电子 PRO 患者的依从性和数据错误。使用广义估计方程模型和两段模型来描述随时间变化的错误发生率轨迹，并确定风险因素。
在 678 例患者中，629 例至少有 2 次 PRO 评估，440 例完成了 3347 次纸质评估，189 例完成了 1291 次电子 PRO 评估。共有 49.4%的患者至少有一次错误，包括（1）漏项（64.69%，1070/1654），（2）未经签名的修改（27.99%，463/1654），（3）选择多个选项（3.02%，50/1654），（4）患者签名缺失（2.54%，42/1654），（5）研究人员签名缺失（1.45%，24/1654），和（6）缺少完成日期（0.30%，5/1654）。完成电子 PRO 的患者比完成纸质评估的患者错误更少（电子 PRO：30.2%[57/189] vs. 纸质评估：57.7%[254/440]；P<.001）。与电子 PRO 患者相比，使用纸质评估的患者年龄较大，教育程度较低，病情较重。常见的错误风险因素是较低的教育水平（纸质评估：优势比[OR]1.39，95%置信区间[CI]1.20-1.62；P<.001；电子 PRO：OR 1.82，95% CI 1.22-2.72；P=.003），在省级医院治疗（纸质评估：OR 3.34，95% CI 2.10-5.33；P<.001；电子 PRO：OR 4.73，95% CI 2.18-10.25；P<.001），以及疾病严重程度（纸质评估：OR 1.63，95% CI 1.33-1.99；P<.001；电子 PRO：OR 2.70，95% CI 1.53-4.75；P<.001）。纸质评估的错误在术后第 1 天（POD1）达到峰值，而电子 PRO 的错误在第 2 天（POD2）达到峰值。
与纸质评估相比，使用电子 PRO 可以提高纵向采集 PRO 的数据质量。然而，在使用纵向 PRO 作为主要结局进行临床研究设计时，需要考虑与电子 PRO 相关的抽样偏差。
