Ngaage Dumbor L, Mitchell Natasha, Dean Alexandra, Mitchell Alex, Hinde Sebastian, Akowuah Enoch, Doherty Patrick, Nichols Simon, Fairhurst Caroline, Flemming Kate, Hewitt Catherine, Ingle Lee, Watson Judith
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Castle Road Cottingham, Hull, UK.
Department of Health Sciences, University of York, ARRC Building, York, UK.
Pilot Feasibility Stud. 2023 May 11;9(1):79. doi: 10.1186/s40814-023-01304-3.
To determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable.
A randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates.
Fifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings.
Recruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR.
ISRCTN80441309 (prospectively registered on 24/01/2019).
与标准做法相比，确定心脏手术后早期门诊复查及早期心脏康复（CR）的可接受性和可行性，以确定未来是否能够开展大规模试验。
一项包含健康经济评估和定性访谈的随机对照可行性试验，从英国两家心脏中心招募年龄在18至80岁之间、通过正中胸骨切开术接受择期或急诊心脏手术的患者。符合条件且同意参与的参与者由远程集中随机化服务按1:1随机分组，一组在出院后6周进行术后门诊复查，随后从8周开始进行CR（对照组）；另一组在出院后3周进行术后门诊复查，随后从4周开始进行CR（干预组）。主要结局指标与试验可行性相关，包括招募、留存、CR依从性以及参与者/工作人员的可接受性。次要结局指标包括使用EQ-5D-5L的健康相关生活质量、国民保健服务资源利用情况、递增穿梭步行试验（ISWT）距离、30天和90天死亡率、手术部位并发症及再入院率。
50名参与者被随机分组（每组25名），92%的参与者被判定适合进行CR。最终随访时参与者留存率为74%；ISWT结局数据时间点的完成率在28%至92%之间，随访问卷的完成率在68%至94%之间。在每个时间点，干预组的平均ISWT步行距离均大于对照组。干预组的平均效用评分从基线到最终随访增加了0.202（对照组为0.188）。干预组的总成本为1519英镑（对照组为2043英镑）。对15名参与者和一名研究护士进行了访谈。许多对照组参与者认为他们的门诊复查和CR本可以更早进行；干预组参与者则认为时机合适。研究护士发现，由于出院时间安排，为愿意参与的患者获取同意书具有挑战性。
招募和留存率表明，在进行一些调整以最大化招募的情况下，开展全面试验是可行的。低于预期的招募率以及一项临床测试出现的问题是本研究的局限性。大多数研究程序对参与者以及提供早期CR的专业人员来说证明是可行且可接受的。
ISRCTN80441309（于2019年1月24日前瞻性注册）。
