Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
Chapel Allerton Hospital, Leeds, UK.
BMJ Open. 2024 Jul 11;14(7):e083069. doi: 10.1136/bmjopen-2023-083069.
The aim of the knee arthroplasty versus joint distraction (KARDS) randomised trial was to investigate whether knee joint distraction (KJD) is non-inferior to knee arthroplasty, also known as knee replacement (KR). Here we report the findings from qualitative interviews that were part of the planned KARDS process evaluation.
Semi-structured qualitative interviews with staff and participants in secondary care. Data were analysed using thematic content analysis.
We were unable to complete the full-planned KARDS process evaluation as recruitment to the trial was closed early but key common themes emerged.Eleven members of staff were interviewed from two KARDS sites (eight initial interviews just after site opening and three follow-up interviews at 12 months). Eleven KARDS participants (six KR and five KJD) were interviewed. One overarching theme emerged: 'An unexpected journey'. This incorporated subthemes including 'an important research question', 'a roller coaster ride', 'lessons learnt', 'managing expectations' and 'a slow recovery'. These encapsulate experiences of both staff and participants.
The information that we were able to collect highlights that providing adequate and comprehensive information about all aspects of treatment including estimated timelines of recovery are essential in clinical trials of novel interventions. Incorporating a comprehensive rehabilitation package following KJD was a key learning. Process evaluations in these complex trials are essential to determine issues as early as possible so appropriate changes can be made to ensure participants have a smooth journey through the trial experience.
ISRCTN14879004.
膝关节置换与关节牵张术（KARDS）随机试验的目的是研究膝关节牵张术（KJD）是否不劣于膝关节置换术（KR）。在这里，我们报告了作为 KARDS 计划过程评估的一部分的定性访谈结果。
对二级保健机构的工作人员和参与者进行半结构定性访谈。使用主题内容分析对数据进行分析。
我们无法完成完整的 KARDS 计划过程评估，因为该试验的招募提前结束，但出现了一些关键的共同主题。从两个 KARDS 地点采访了 11 名工作人员（在地点开放后立即进行了 8 次初步访谈，12 个月时进行了 3 次随访访谈）。采访了 11 名 KARDS 参与者（6 名 KR 和 5 名 KJD）。出现了一个总体主题：“一次意想不到的旅程”。这包含了子主题，包括“一个重要的研究问题”、“过山车之旅”、“经验教训”、“管理期望”和“缓慢康复”。这些涵盖了工作人员和参与者的经验。
我们能够收集的信息表明，在新干预措施的临床试验中，提供有关治疗所有方面的充分和全面的信息至关重要，包括估计的恢复时间表。在 KJD 之后纳入全面的康复方案是一个关键的学习。在这些复杂的试验中进行过程评估至关重要，可以尽早确定问题，以便可以进行适当的更改，以确保参与者在试验过程中顺利进行。
ISRCTN86005155。
