Williams Nefyn H, Roberts Jessica L, Din Nafees Ud, Totton Nicola, Charles Joanna M, Hawkes Claire A, Morrison Val, Hoare Zoe, Williams Michelle, Pritchard Aaron W, Alexander Swapna, Lemmey Andrew, Woods Robert T, Sackley Catherine, Logan Pip, Edwards Rhiannon T, Wilkinson Clare
School of Healthcare Sciences, Bangor University, Wrexham, UK Betsi Cadwaladr University Health Board, North Wales, UK.
School of Healthcare Sciences, Bangor University, Wrexham, UK.
BMJ Open. 2016 Oct 5;6(10):e012422. doi: 10.1136/bmjopen-2016-012422.
To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.
Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.
Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.
Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.
Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.
62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.
The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT.
ISRCTN22464643; Results.
为未来一项关于髋部骨折强化康复方案的确定性平行组随机对照试验（RCT）及经济学评估进行严格的可行性研究。
从北威尔士的3家急症医院招募患者。在社区提供干预措施。
年龄≥65岁、因髋部骨折接受手术治疗、骨折前独立生活、具备精神能力（由临床团队评估）且在北威尔士地区接受康复治疗的老年人。
通过远程随机分组，分为常规护理（对照组）或常规护理+强化康复方案（干预组），强化康复方案包括由物理治疗师或技术指导提供的另外6次居家物理治疗课程、新颖的信息手册和目标设定日记。
主要指标：巴氏日常生活活动能力（BADL）。次要指标包括诺丁汉扩展日常生活活动量表（NEADL）、EQ-5D、ICECAP能力、一系列自我效能、心理社会和服务使用指标以及成本。结局指标由盲法研究人员在基线和3个月随访时进行评估。
招募了62名参与者，61名被随机分组（对照组32名；干预组29名），49名（79%）完成了3个月随访。两组在大多数结局指标上差异极小，包括BADL（调整后平均差异为0.5）。干预组相对于对照组NEADL有中等程度改善，组间调整后平均差异为3.0（科恩d值为0.63），自我效能和心理健康有更大改善的趋势，但效应量较小。提供干预措施的平均成本为每位患者231英镑。干预组在质量调整生命年方面有小幅相对改善。未报告与干预相关的严重不良事件。
该试验方法在入选标准、招募和留存方面是可行的。康复方案的有效性和成本效益应在III期RCT中进行检验。
ISRCTN22464643；结果
