BACKGROUND Dislocation, periprosthetic fracture and infection are serious complications of total hip replacement (THR) and which negatively impact on patients' outcomes including satisfaction, quality of life, mental health and function. The accuracy with which patients report adverse events (AEs) after surgery varies. The impact of patient self-reporting of AEs on patient-reported outcome measures (PROMs) after THR is yet to be investigated. Our aim was to determine the effect of confirmed and perceived AEs on PROMs after primary THR. METHODS A prospective single-centre cohort study of patients undergoing primary THR, with one-year follow-up, was performed. Participants completed forms pre-operatively and 3, 6, 9 and 12 months post-operatively, including Work Productivity and Activity Impairment (WPAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol-5D-3 L (EQ5D), Self-Administered Patient Satisfaction (SAPS) and AE reporting questionnaires. Results were reported in three groups: No AE, reported but not confirmed AE and confirmed AE. A generalised linear model was used to compare among groups using robust standard errors (SE). RESULTS Forty-one AEs were reported in a cohort of 417 patients (234 females), with 30 AEs reported by 3 months. Eleven (27 reported) infections, two (six reported) periprosthetic fractures and two (eight reported) dislocations were confirmed. Those in the no AE group reported significantly better outcomes that the reported AE group as measured by WOMAC Co-Eff 14.27 (p = 0.01), EQ5D - 0.128 (p = 0.02) and SAPS - 9.926 (p = 0.036) and the combined reported and confirmed AE groups as measured by WOMAC Co-Eff 13.72 (p = 0.002), EQ5D - 0.129 (p = 0.036) and SAPS - 11.512 (p = 0.004). No significant differences were seen in WPAI among groups. CONCLUSIONS Patients who report AEs have worse outcomes than those who do not, regardless of whether the AEs can be confirmed by standard medical record review methods. The observed negative trends suggest that patient perception of AEs may influence patient outcome in a similar way to those with confirmed AEs.

中文翻译：

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认为发生的不良事件会影响全髋关节置换术后患者报告的结局。

背景技术脱位，假体周围骨折和感染是全髋关节置换术（THR）的严重并发症，会对患者的结局产生负面影响，包括满意度，生活质量，心理健康和功能。患者手术后报告不良事件（AE）的准确性各不相同。THR后患者自我报告不良事件对患者报告结果指标（PROM）的影响尚待研究。我们的目的是确定原发性THR后已确认和感知的AE对PROM的影响。方法进行了一项前瞻性单中心队列研究，该研究对接受原发性THR的患者进行了为期一年的随访。参与者在术前以及术后3、6、9和12个月填写表格，包括工作效率和活动障碍（WPAI），西安大略省和麦克马斯特大学的骨关节炎指数（WOMAC），EuroQol-5D-3 L（EQ5D），自我管理的患者满意度（SAPS）和AE报告问卷。将结果报告为三组：无AE，报告但未确认AE和已确认AE。使用鲁棒的标准误差（SE），使用广义线性模型在组之间进行比较。结果417名患者（234名女性）队列中报告了41例AE，至3个月时报告了30例AE。确认了11例（报告27例）感染，2例（报告6例）假体周围骨折和2例（报告8例）脱位。通过WOMAC Co-Eff 14.27（p = 0.01），EQ5D-0.128（p = 0.02）和SAPS-9.926（p = 0）测得，无AE组的患者报告的结局明显优于报告的AE组。036）以及报告的和确认的AE组合，分别由WOMAC Co-Eff 13.72（p = 0.002），EQ5D-0.129（p = 0.036）和SAPS-11.512（p = 0.004）测量。各组之间的WPAI差异均无统计学意义。结论不论是否可以通过标准的病历复查方法确认不良事件，报告不良事件的患者的结局均较未发生不良事件的患者差。观察到的负面趋势表明，患者对AE的感知可能以与确认AE相似的方式影响患者的预后。