Department of Public and Occupational Health, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.
Amsterdam Public Health, Societal Participation and Health, Quality of Care, Van Der Boechorststraat 8, 1081 BT, Amsterdam, the Netherlands.
BMC Musculoskelet Disord. 2023 Mar 16;24(1):199. doi: 10.1186/s12891-023-06203-5.
Optimizing return to work (RTW) after knee arthroplasty (KA) is becoming increasingly important due to a growing incidence of KA and poor RTW outcomes after KA. We developed the Back At work After Surgery (BAAS) clinical pathway for optimized RTW after KA. Since the effectiveness and cost analysis of the BAAS clinical pathway are still unknown, analysis on effectiveness and costs of BAAS is imperative.
This protocol paper has been written in line with the standards of Standard Protocol Items: Recommendations for Interventional Trails. To assess the effectiveness and cost-effectiveness for RTW, we will perform a multicenter prospective cohort study with patients who decided to receive a total KA (TKA) or an unicompartmental KA (UKA). To evaluate the effectiveness of BAAS regarding RTW, a comparison to usual care will be made using individual patient data on RTW from prospectively performed cohort studies in the Netherlands.
One of the strengths of this study is that the feasibility for the BAAS clinical pathway was tested at first hand. Also, we will use validated questionnaires and functional tests to assess the patient's recovery using robust outcomes. Moreover, the intervention was performed in two hospitals serving the targeted patient group and to reduce selection bias and improve generalizability. The limitations of this study protocol are that the lead author has an active role as a medical case manager (MCM) in one of the hospitals. Additionally, we will use the data from other prospective Dutch cohort studies to compare our findings regarding RTW to usual care. Since we will not perform an RCT, we will use propensity analysis to reduce the bias due to possible differences between these cohorts.
This study was retrospectively registered at clinicaltrails.gov ( https://clinicaltrials.gov/ct2/show/NCT05690347 , date of first registration: 19-01-2023).
膝关节置换术后（KA）的重返工作（RTW）优化变得越来越重要，因为 KA 的发病率不断增加，且术后 RTW 结果不佳。我们开发了 Back At work After Surgery（BAAS）临床路径，以优化 KA 后的 RTW。由于 BAAS 临床路径的有效性和成本分析尚不清楚，因此对 BAAS 的效果和成本效益进行分析是必要的。
本方案论文是按照标准干预试验推荐项目的标准编写的。为了评估 RTW 的有效性和成本效益，我们将对决定接受全膝关节置换术（TKA）或单髁膝关节置换术（UKA）的患者进行多中心前瞻性队列研究。为了评估 BAAS 对 RTW 的有效性，将使用荷兰前瞻性队列研究中关于 RTW 的个体患者数据，与常规护理进行比较。
这项研究的一个优势是首先测试了 BAAS 临床路径的可行性。此外，我们将使用经过验证的问卷和功能测试来评估患者的恢复情况，使用可靠的结果。此外，干预在两家为目标患者群体服务的医院进行，以减少选择偏倚并提高可推广性。本研究方案的局限性在于，主要作者在其中一家医院担任医疗个案经理（MCM），具有积极的作用。此外，我们将使用其他荷兰前瞻性队列研究的数据来比较我们关于 RTW 的发现与常规护理。由于我们不会进行 RCT，我们将使用倾向评分分析来减少因这些队列之间可能存在的差异而导致的偏差。
本研究在 clinicaltrials.gov 上进行了回顾性注册（https://clinicaltrials.gov/ct2/show/NCT05690347，首次注册日期：2023 年 1 月 19 日）。
