全膝关节置换术联合非手术治疗的成本效益：丹麦二级保健中一项随机试验的 2 年结果。
Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark.
机构信息
Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, Syddansk Universitet, Odense, Syddanmark, Denmark
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals, Region Zealand, Slagelse, Denmark.
出版信息
BMJ Open. 2020 Jan 15;10(1):e033495. doi: 10.1136/bmjopen-2019-033495.
OBJECTIVE
To assess the 24-month cost-effectiveness of total knee replacement (TKR) plus non-surgical treatment compared with non-surgical treatment with the option of later TKR if needed.
METHODS
100 adults with moderate-to-severe knee osteoarthritis found eligible for TKR by an orthopaedic surgeon in secondary care were randomised to TKR plus 12 weeks of supervised non-surgical treatment (exercise, education, diet, insoles and pain medication) or to supervised non-surgical treatment alone. Including quality-adjusted life years (QALYs) data from baseline, 3, 6, 12 and 24 months, effectiveness was measured as change at 24 months. Healthcare costs and transfer payments were derived from national registries. Incremental healthcare costs, and incremental cost-effectiveness ratios (ICERs) were calculated. A probabilistic sensitivity analysis was conducted and the probability of cost-effectiveness was estimated at the 22 665 Euros/QALY threshold defined by the National Institute for Health and Care Excellence.
RESULTS
TKR plus non-surgical treatment was more expensive (mean of 23 076 vs 14 514 Euros) but also more effective than non-surgical treatment (mean 24-month improvement in QALY of 0.195 vs 0.056). While cost-effective in the unadjusted scenario (ICER of 18 497 Euros/QALY), TKR plus non-surgical treatment was not cost-effective compared with non-surgical treatment with the option of later TKR if needed in the adjusted (age, sex and baseline values), base-case scenario (ICER of 32 611 Euros/QALY) with a probability of cost-effectiveness of 23.2%. Including deaths, TKR plus non-surgical treatment was still not cost-effective (ICERs of 46 277 to 64 208 Euros/QALY).
CONCLUSIONS
From a 24-month perspective, TKR plus non-surgical treatment does not appear to be cost-effective compared with non-surgical treatment with the option of later TKR if needed in patients with moderate-to-severe knee osteoarthritis and moderate intensity pain in secondary care in Denmark. Results were sensitive to changes, highlighting the need for further confirmatory research also assessing the long-term cost-effectiveness of TKR.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov (NCT01410409).
目的
评估全膝关节置换术（TKR）加非手术治疗与仅非手术治疗（包括锻炼、教育、饮食、鞋垫和止痛药物）相比在 24 个月时的成本效益，后者在必要时可选择后期 TKR。
方法
100 名在二级保健机构由矫形外科医生认为适合 TKR 的成年人被随机分为 TKR 加 12 周的监督非手术治疗（锻炼、教育、饮食、鞋垫和止痛药物）或仅监督非手术治疗。包括基线、3、6、12 和 24 个月的质量调整生命年（QALY）数据，有效性以 24 个月时的变化来衡量。医疗保健成本和转移支付来自国家登记处。计算增量医疗保健成本和增量成本效益比（ICER）。进行概率敏感性分析，并根据国民健康与保健卓越研究所定义的 22665 欧元/QALY 阈值估计成本效益的概率。
结果
TKR 加非手术治疗更昂贵（TKR 加非手术治疗的平均值为 23076 欧元，而非手术治疗的平均值为 14514 欧元），但也更有效（24 个月时 QALY 的平均改善值为 0.195 比 0.056）。在未调整的情况下，TKR 加非手术治疗具有成本效益（ICER 为 18497 欧元/QALY），但在调整后的（年龄、性别和基线值）基本情况下，TKR 加非手术治疗与必要时选择后期 TKR 的非手术治疗相比不具有成本效益（ICER 为 32611 欧元/QALY），成本效益的概率为 23.2%。包括死亡，TKR 加非手术治疗仍然不具有成本效益（ICER 为 46277 至 64208 欧元/QALY）。
结论
从 24 个月的角度来看，在丹麦二级保健机构中度至重度膝关节骨关节炎且疼痛强度中度的患者中，TKR 加非手术治疗似乎并不比必要时选择后期 TKR 的非手术治疗更具成本效益。结果对变化敏感，突出表明需要进一步的确认性研究，也评估 TKR 的长期成本效益。
试验注册
ClinicalTrials.gov（NCT01410409）。
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