Wylde Vikki, Bertram Wendy, Sanderson Emily, Noble Sian, Howells Nicholas, Peters Tim J, Beswick Andrew D, Blom Ashley W, Moore Andrew J, Bruce Julie, Walsh David A, Eccleston Christopher, Harris Shaun, Garfield Kirsty, White Simon, Toms Andrew, Gooberman-Hill Rachael
Bristol Medical School, University of Bristol, Bristol, UK.
National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, UK.
Lancet Rheumatol. 2022 Jan 28;4(3):e188-e197. doi: 10.1016/S2665-9913(21)00371-4. eCollection 2022 Mar.
Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement.
We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.
Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group.
STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery.
National Institute for Health Research.
约20%的人在全膝关节置换术后会经历慢性疼痛，但目前尚无有效的治疗方法。我们旨在评估一种针对全膝关节置换术后慢性疼痛的新型护理途径的临床疗效和成本效益。
我们在英国8家国民健康服务（NHS）医院进行了一项非盲、平行组、实用、优效性、随机对照试验。全膝关节置换术后3个月出现慢性疼痛的患者被随机分配（2:1）接受置换后支持与治疗（STAR）护理途径加常规护理，或仅接受常规护理。STAR干预旨在通过由扩展范围从业者进行的术后3个月评估以及12个月的电话随访，确定慢性疼痛的潜在原因，并促成针对性治疗的进一步转诊。共同主要结局是自我报告的疼痛严重程度以及置换膝关节处的疼痛干扰，使用简明疼痛量表（BPI）的疼痛严重程度和干扰量表在12个月时进行评估（评分0 - 10分，从最佳到最差），并按随机分组情况进行分析。从电子医院记录和参与者处收集的资源使用情况，根据英国参考成本进行估值。根据EQ - 5D - 5L回答计算质量调整生命年（QALYs）。本试验已在国际标准随机对照试验编号注册库（ISRCTN）注册，编号为ISRCTN92545361。
在2016年9月6日至2019年5月31日期间，363名参与者被随机分配接受干预加常规护理（n = 242）或仅接受常规护理（n = 121）。参与者的年龄中位数为67岁（四分位间距61至73岁），363名参与者中有217名（60%）为女性，335名（92%）为白人。313名（86%）患者在随机分组后12个月提供了随访数据（213名被分配接受干预加常规护理，100名被分配仅接受常规护理）。在12个月时，BPI严重程度评分的组间平均差异为 - 0.65（95%置信区间 - 1.17至 - 0.13；p = 0.014），BPI干扰评分的组间平均差异为 - 0.68（ - 1.29至 - 0.08；p = 0.026），两者均有利于干预组。从NHS和个人社会服务的角度来看，该干预具有成本效益（以更低成本实现更大改善），在每QALY阈值为20000英镑时，增量净货币效益为1256英镑（95%置信区间164至2348英镑）。干预组报告了1例参与者痛苦的不良反应。
STAR是一种临床有效且具有成本效益的干预措施，可改善全膝关节置换术后3个月出现慢性疼痛的患者1年内的疼痛结局。
英国国家卫生研究院。
Zotero 插件