Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Health Technol Assess. 2010 Jan;14(5):1-180. doi: 10.3310/hta14040.
To ascertain the acceptability of a randomised controlled trial comparing arthroscopic lavage with a placebo-surgical procedure for the management of osteoarthritis of the knee; and to assess the practical feasibility of mounting such a multicentre placebo-controlled trial.
Mixed methods study including: focus groups with surgeons and anaesthetists; focus groups and interviews with potential participants; interviews with chairpersons of UK Multicentre Research Ethics Committees (MRECs); surveys of surgeons and anaesthetists; and a two-centre, three-arm pilot.
UK secondary care.
Members of the British Association of Surgeons of the Knee and members of the British Society of Orthopaedic Anaesthetists took part in the focus groups and surveys. Surgeons and anaesthetists from two regional centres in the UK also contributed to focus groups, as did patients from consultant lists in two UK regional centres, and members of Arthritis Care. Chairpersons of six UK MRECs were interviewed. Participants were eligible for the pilot if they were adults (18 years or older) with radiological evidence of osteoarthritis of the knee who might be considered for arthroscopic lavage, and were fit for general anaesthetic (defined by the American Society of Anaesthesiologists grades 1 and 2), and able to give informed consent.
Participants in the pilot study were randomised to arthrosocopic lavage (with or without debridement at the clinical discretion of the surgeon); placebo surgery; or non-operative management with specialist reassessment.
The acceptability and feasibility of mounting a placebo-controlled trial for the evaluation of knee arthroscopic lavage.
There was broad acceptance across all stakeholder groups of the need to find out more about the effectiveness of arthroscopic lavage. Despite this there was variation in opinion within all the groups about how researchers should approach this and whether or not it would be acceptable to investigate using placebo surgery. Within the health professional groups, there tended to be a split between those who were strongly opposed to the inclusion of a placebo surgery arm and those who were more in favour. For prospective trial participants who had osteoarthritis of the knee, the acceptability of the trial was discussed from a more individual perspective - reflecting on their personal reasons for or against participating. The majority of this group said they would consider taking part. The pilot study showed that, in principle, a placebo-controlled trial could be conducted. It showed that patients were willing to participate in a trial which would involve a placebo-surgical arm and that it was possible to undertake placebo surgery successfully and to blind patients to their allocation - although once patients knew their allocation, some patients allocated to surgery became more concerned about the possibility of undergoing placebo surgery, and withdrew. The experience of the pilot, however, showed that, despite full MREC approval, the study required major discussion and negotiation before local clinical approvals could be obtained. The fact that ethics approval had been granted did not mean that clinicians would automatically accept that the process was ethical.
The study showed that, in principle, a placebo-controlled trial of arthroscopic lavage could be conducted in the UK, albeit with difficulty. Against the background of falling use of arthroscopic lavage the decision was, therefore, taken not to proceed to full-scale trial for this procedure. The study showed that for some health professionals the use of placebo surgery can never be justified. It highlighted the importance of the surgeon-anaesthetist relationship in this context and how acceptance of the trial design by both parties is essential to successful participation. It also highlighted the importance of informed consent for trial participants and the strength and influence of individuals' ethical perspectives in addition to collective ethics provided by MRECs.
Current Controlled Trials ISRCTN02328576.
确定一项比较关节镜灌洗术与安慰剂手术治疗膝关节骨关节炎的随机对照试验的可接受性；并评估开展这种多中心安慰剂对照试验的实际可行性。
混合方法研究，包括：外科医生和麻醉师的焦点小组；潜在参与者的焦点小组和访谈；英国多中心伦理委员会（MREC）主席的访谈；外科医生和麻醉师的调查；以及两中心、三臂的试点研究。
英国二级保健。
英国膝关节外科协会的成员和英国矫形麻醉师协会的成员参加了焦点小组和调查。英国两个地区中心的外科医生和麻醉师也参加了焦点小组，来自英国两个地区中心顾问名单的患者以及关节炎护理协会的成员也参加了焦点小组。采访了六个英国 MREC 的主席。如果他们是成年人（18 岁或以上），有膝关节骨关节炎的放射学证据，可能需要进行关节镜灌洗，并且适合全身麻醉（由美国麻醉师协会 1 级和 2 级定义），并且能够给予知情同意，则有资格参加试点研究。
参加试点研究的患者被随机分配接受关节镜灌洗（根据外科医生的临床判断进行或不进行清创术）；安慰剂手术；或非手术治疗，由专家重新评估。
评估膝关节关节镜灌洗效果的安慰剂对照试验的可接受性和可行性。
所有利益攸关方都广泛接受需要更多地了解关节镜灌洗的有效性。尽管如此，所有群体内部对研究人员应该如何处理这个问题以及是否可以通过使用安慰剂手术来调查存在不同意见。在卫生专业人员群体中，存在强烈反对包括安慰剂手术组和更赞成这种手术组之间的分歧。对于患有膝关节骨关节炎的潜在试验参与者，从个人角度讨论了试验的可接受性 - 反映了他们参加试验的个人原因。大多数参与者表示他们会考虑参加。试点研究表明，原则上可以进行安慰剂对照试验。它表明患者愿意参加涉及安慰剂手术组的试验，并且可以成功地进行安慰剂手术并使患者对其分配保持盲目-尽管一旦患者知道他们的分配，一些分配给手术的患者对接受安慰剂手术的可能性更加关注，并退出了。然而，试点研究的经验表明，尽管获得了完整的 MREC 批准，但在获得当地临床批准之前，仍需要进行大量的讨论和协商。伦理批准的事实并不意味着临床医生会自动认为该过程是合乎道德的。
该研究表明，原则上可以在英国开展关节镜灌洗的安慰剂对照试验，但存在困难。鉴于关节镜灌洗的使用不断减少，因此决定不对该手术进行全面的试验。该研究表明，对于一些卫生专业人员来说，使用安慰剂手术永远是不合理的。它突出了外科医生-麻醉师关系在这方面的重要性，以及双方接受试验设计对成功参与的重要性。它还强调了试验参与者的知情同意的重要性以及个人伦理观点的力量和影响，以及 MREC 提供的集体伦理观点。
当前对照试验 ISRCTN02328576。
