Safety of disinvestment in mid- to late-term follow-up post primary hip and knee replacement: the UK SAFE evidence synthesis and recommendations

S. Kingsbury, L. Smith, C. C. Czoski Murray, R. Pinedo-Villanueva, A. Judge, R. West, Chris Smith, J. Wright, N. Arden, Christine M Thomas, Spryos Kolovos, F. Shuweihdi, C. Garriga, Byron KY Bitanihirwe, K. Hill, J. Matu, M. Stone, P. Conaghan
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Our recommendations are as follows: for Orthopaedic Data Evaluation Panel 10A* (ODEP-10A*) minimum implants, it is safe to disinvest in routine follow-up from 1 to 10 years post non-complex hip and knee replacement provided that there is rapid access to orthopaedic review; (2) for ODEP-10A* minimum implants in complex cases or non-ODEP-10A* minimum implants, periodic follow-up post hip and knee replacement may be required from 1 to 10 years; (3) at 10 years post hip and knee replacement, clinical and radiographic evaluation is recommended; and (4) after 10 years post hip and knee replacement, frequency of further follow-up should be based on the 10-year assessment (note that ongoing rapid access to orthopaedic review is still required) [Stone M, Smith L, Kingsbury S, Czoski-Murray C, Judge A, Pinedo-Villanueva R, et al. Evidence-based follow-up recommendations following primary hip and knee arthroplasty (UK SAFE). Orthop Proc 2020;102–B:13. https://doi.org/10.1302/1358-992X.2020.5.013].\n \n \n \n The current absence of data beyond 10 years restricted the evidence base.\n \n \n \n For ODEP-10A* prostheses, the UK SAFE programme demonstrated that it is safe to disinvest in routine follow-up in the 1- to 10-year period after non-complex hip and knee replacement. At 10 years, clinical and radiographic review is recommended. Complex cases, implants not meeting the 10A* criteria and follow-up after revision surgery are not covered by this recommendation.\n \n \n \n The evidence base for follow-up after 10 years requires further evaluation. Further work should establish the most clinically effective and cost-effective model of delivering a rapid access service and evaluate alternative models for follow-up services, such as virtual clinics. 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引用次数: 1

Abstract

Joint replacement surgery has revolutionised the management of degenerative joint disease. Increasing demand for surgery and post-surgical reviews has overwhelmed orthopaedic services and, consequently, many centres have reduced or stopped follow-up. Such disinvestment is without an evidence base and raises questions regarding the consequences to patients. To produce evidence- and consensus-based recommendations as to how, when and on whom follow-up should be conducted. Our research question was ‘Is it safe to disinvest in mid- to late-term follow-up of hip and knee replacement?’. The study comprised three complementary evidence synthesis work packages to inform a final consensus process. Work package 1 was a systematic review of the clinical effectiveness and cost-effectiveness literature. Work package 2 used routine national data sets (i.e. the Clinical Practice Research Datalink–Hospital Episode Statistics, Hospital Episode Statistics–National Joint Registry–patient-reported outcome measures) to identify pre, peri and postoperative predictors of mid- to late-term revision, and prospective data from 560 patients to understand how patients present for revision surgery. Work package 3 used a Markov model to simulate the survival, health-related quality of life and NHS costs of patients following hip or knee replacement surgery. Finally, evidence from work packages 1–3 informed a face-to-face consensus panel, which involved 32 stakeholders. Our overarching statements are as follows: (1) these recommendations apply to post primary hip and knee replacement follow-up; (2) the 10-year time point in these recommendations is based on a lack of robust evidence beyond 10 years; and (3) in these recommendations, the term ‘complex cases’ refers to individual patient and surgical factors that may increase the risk of replacement failure. Our recommendations are as follows: for Orthopaedic Data Evaluation Panel 10A* (ODEP-10A*) minimum implants, it is safe to disinvest in routine follow-up from 1 to 10 years post non-complex hip and knee replacement provided that there is rapid access to orthopaedic review; (2) for ODEP-10A* minimum implants in complex cases or non-ODEP-10A* minimum implants, periodic follow-up post hip and knee replacement may be required from 1 to 10 years; (3) at 10 years post hip and knee replacement, clinical and radiographic evaluation is recommended; and (4) after 10 years post hip and knee replacement, frequency of further follow-up should be based on the 10-year assessment (note that ongoing rapid access to orthopaedic review is still required) [Stone M, Smith L, Kingsbury S, Czoski-Murray C, Judge A, Pinedo-Villanueva R, et al. Evidence-based follow-up recommendations following primary hip and knee arthroplasty (UK SAFE). Orthop Proc 2020;102–B:13. https://doi.org/10.1302/1358-992X.2020.5.013]. The current absence of data beyond 10 years restricted the evidence base. For ODEP-10A* prostheses, the UK SAFE programme demonstrated that it is safe to disinvest in routine follow-up in the 1- to 10-year period after non-complex hip and knee replacement. At 10 years, clinical and radiographic review is recommended. Complex cases, implants not meeting the 10A* criteria and follow-up after revision surgery are not covered by this recommendation. The evidence base for follow-up after 10 years requires further evaluation. Further work should establish the most clinically effective and cost-effective model of delivering a rapid access service and evaluate alternative models for follow-up services, such as virtual clinics. Finally, the needs and outcomes of patients who are symptomatic but do not have appropriate follow-up should be investigated. This study is registered as PROSPERO CRD42017053017. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 16. See the NIHR Journals Library website for further project information.
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原发性髋关节和膝关节置换术后中后期随访撤资的安全性:英国SAFE证据综合和建议
关节置换手术彻底改变了退行性关节疾病的治疗。对手术和术后复查的需求不断增加,使整形外科服务不堪重负,因此,许多中心减少或停止了随访。这种撤资没有证据基础,并引发了对患者后果的质疑。就如何、何时以及对谁采取后续行动提出基于证据和共识的建议。我们的研究问题是“在髋关节和膝关节置换术的中后期随访中取消投资安全吗?”。该研究包括三个补充性的证据综合工作包,为最终达成共识进程提供信息。工作包1是对临床有效性和成本效益文献的系统综述。工作包2使用常规的国家数据集(即临床实践研究数据链-医院发作统计、医院发作统计-国家联合登记处-患者报告的结果测量)来确定中晚期翻修的术前、围术中和术后预测因素,以及560名患者的前瞻性数据,以了解患者如何接受翻修手术。工作包3使用马尔可夫模型来模拟髋关节或膝关节置换手术后患者的生存率、健康相关的生活质量和NHS成本。最后,来自工作包1-3的证据为一个面对面的共识小组提供了信息,该小组涉及32个利益相关者。我们的总体声明如下:(1)这些建议适用于初次髋关节和膝关节置换术后的随访;(2) 这些建议中的10年时间点是基于缺乏超过10年的有力证据;(3)在这些建议中,“复杂病例”一词是指可能增加置换失败风险的个别患者和手术因素。我们的建议如下:对于骨科数据评估小组10A*(ODEP-10A*)最小植入物,在非复杂髋关节和膝关节置换术后1至10年的常规随访中,只要能够快速获得骨科审查,就可以安全地取消投资;(2) 对于复杂病例中的最小ODEP-10A*植入物或非最小ODEP-10A植入物,髋关节和膝关节置换术后可能需要1至10年的定期随访;(3) 髋关节和膝关节置换术后10年,建议进行临床和放射学评估;和(4)髋关节和膝关节置换术后10年后,进一步随访的频率应基于10年评估(注意,仍需要持续的快速骨科审查)[Stone M,Smith L,Kingsbury S,Czoski Murray C,Judge A,Pinedo Villanueva R等人。初次髋关节和膝关节置换术后循证随访建议(英国SAFE)。Orthop Proc 2020;102–B:13。https://doi.org/10.1302/1358-992X.2020.5.013]。目前缺乏超过10年的数据限制了证据基础。对于ODEP-10A*假体,英国SAFE计划证明,在非复杂髋关节和膝关节置换术后的1至10年内,在常规随访中取消投资是安全的。建议在10岁时进行临床和放射学检查。本建议不包括复杂病例、不符合10A*标准的植入物以及翻修手术后的随访。10年后随访的证据基础需要进一步评估。进一步的工作应该建立提供快速获取服务的最具临床效果和成本效益的模式,并评估后续服务的替代模式,如虚拟诊所。最后,应调查有症状但没有适当随访的患者的需求和结果。本研究注册为PROSPERO CRD42017053017。该项目由国家卫生与护理研究所(NIHR)卫生与社会护理提供研究计划资助,并将在《卫生与社会保健提供研究》上全文发表;第10卷第16期。有关更多项目信息,请访问NIHR期刊图书馆网站。
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