Views expressed by health professionals
Although none of the surgeons who took part in the focus groups disputed the need for further investigation of the effectiveness or otherwise of arthroscopic lavage, there was extensive debate within the groups about whether a placebo-controlled trial was necessary to generate new knowledge, and whether it was acceptable. For example:
"It would be more ethically correct to compare doing nothing to a lavage first and then look at the results and see"... You don't need to know the benefits of the placebo, it's irrelevant. When you make a clinical decision, you have to decide whether it's lavage or not. And so all you need to know is benefit from lavage and benefit from not doing anything and if the benefit from the lavage is marginal, then you don't do lavage and that's all that you need to do..."(Surgeon 3, Group C)
"What you need to do first is a decent study to actually look at conservative versus operative [management] and then once you've done that decent study, can you consider putting people at risk of placebo operations" (Surgeon 10, Group C)
Other surgeons disagreed, however, arguing that there was a methodological need for a placebo surgical trial because: a) a placebo component is needed to detect a small difference between the groups; and b) that a placebo is needed to attempt to disentangle what (if any) aspect of the arthroscopic lavage procedure is having a positive effect.
Overall, the health professionals tended to be split between: a) those who were strongly opposed to the inclusion of a placebo surgical arm on the grounds that it could lead to potential harm among individuals who could expect no personal benefit; and b) those who were in favour as that they believed the small risks that relatively few people in a placebo surgery trial arm would be exposed to were justified (because they were outweighed by the potential benefit to future patients and broader society of helping to ensure either that a demonstrably effective surgical procedure was used or that a demonstrably ineffective procedure was stopped).
Those opposed to the inclusion of a placebo surgical arm expressed strong personal views on their perceived ethics of such an approach:
"As an anaesthetist I would not anaesthetise someone for sham surgery. I just couldn't! I just think it's immoral and unethical ... I mean it's as simple as that, you wouldn't do it". (Anaesthetist 1, Group A)
"The number who will do this willingly will be very, very small, most of my colleagues would say - no you're joking"...(Anaesthetist 6, Group A)
On the other hand, those in favour pointed to the benefit to future patients and the desire to let patients rather than clinicians decide what was best for them:
"If the patient is prepared to accept the risk in order to have the operation and they are prepared to enter the trial on the understanding that they might not have an operation, are we all being a bit precious [ie, overly protective]?" (Anaesthetist 4, Group B)
"34,000 people ... per year are having a procedure which has no proof to it. So you're already doing the ladies with the [weak] hearts, putting the tourniquets up, giving them the drugs for absolutely no proven evidence... at the moment if there are 34,000 of these procedures being done and we are exposing that number of patients to all the risks of anaesthesia then we need to know the answer" (Anaesthetist 5, Group A)
Some individuals who were personally in favour of using a placebo were concerned that professional regulators would not be (with consequent implications for their potential participation):
"Interesting though ... I accept [it] is completely logical that the needs of the many outweigh the needs of the few but the GMC [General Medical Council] doesn't see that do they? The GMC make it very specific in their guidance to us that it is the needs of the individual which is your primary concern" (Anaesthetist 4, Group B)
One hundred and seventy three (43%) members of the British Association of Surgeons of the Knee responded to the survey as did 136 (34%) members of the British Society of Orthopaedic Anaesthetists (Table
2). Findings from the surveys supported the insights observed in the focus groups. The surveys showed that a sizeable percentage of health professionals (51% of surgeons and 40% of anaesthetists) were supportive of a trial with a placebo arm being mounted. The survey also showed that 43% of surgeons would personally consider taking part in such a trial as would 47% of anaesthetists. It was interesting to note that although some anaesthetists were personally not in favour of a placebo arm being involved they would, however, consider taking part if their surgeon colleagues wished to take part.
Table 2
Attitudes of surgeons and anaesthetists to a placebo controlled trial
Number of questionnaires despatched | 382 | 398 |
Number (%) of questionnaire returned | 173 (45%) | 136 (34%) |
Potential trial of arthroscopic lavage vs placebo surgery vs conservative management:
|
n/N (%)
|
n/N (%)
|
• Supportive of trial with placebo arm being mounted | 85/168 (50.6) | 54/135 (40.0) |
• Would consider taking part in a trial with a placebo arm | 71/166 (42.8) | 63/134 (47.0) |
• Would encourage a friend or family member to sign up for a trial with a placebo arm | 67/168 (39.9) | 48/135 (35.6) |
As part of the survey we also asked surgeons and anaesthetists for their views on the appropriate randomisation ratio for any potential trial. The majority favoured an allocation ratio of 1:1:1 to arthroscopic lavage, placebo surgery or non-operative management (60% of surgeons, 46% anaesthetists) or had no preference (25% surgeons, 41% anaesthetists), rather than a 2:1:1 ratio (10% surgeons, 10% anaesthetists) or some other ratio (5% surgeons, 3% anaesthetists).
Views expressed by people with osteoarthritis
In their focus groups and interviews, people with osteoarthritis echoed the need to find out more about the effects of arthroscopic lavage, and many of our sample indicated that they would consider taking part in a placebo-controlled trial. Two participants also discussed how, from a research point of view, including a placebo surgical component could be very useful. They drew on the information presented by the interviewers and explained that a placebo arm would help check whether any perceived benefit from arthroscopic lavage was due to a placebo effect. For example:
"... I would say it is important to have the placebo in it because if there is a sort of mind set that it does help to heal you, I mean it has been proven over the years that placebos do benefit in certain things." (Participant 1)
"... I think the placebo group is a very good idea because it can almost fool somebody into thinking they have had a procedure when they haven't and basically prove to some people that you think you are better because you think you have had this procedure but in fact you didn't have any treatment done at all."(Participant 2)
However, a few people in our sample thought involvement in a placebo-controlled trial would not be appropriate for them:
"if I was informed then that I had had the placebo and I realised that I had still got the pain I would be so furious...so angry" (Participant 14)
Those who were willing to take part openly acknowledged the risks of general anaesthetic and endorsed the need for anaesthetists to select only those at low risk. For example:
"... there is always, albeit I think it is quite small, risk of complications with anaesthesia ... there can be problems but they are very few and far between and if the right patients are selected then I don't think there would be any problems." (Participant 2)
Views expressed by Chairs of Ethics Committees
The Chairs of Ethics Committees highlighted a range of issues that should be addressed in any ethics application, eg, justifying the need for the placebo and the general anaesthetic, plans for minimising risks to patients, etc. Whilst they acknowledged that a surgical placebo-controlled trial would not simply be dismissed on principle, they predicted a "rough journey" through the ethics process for any such proposal:
"... I would have to think extremely laterally to envisage that this would get through without a very rough journey on the way ... We have one committee in particular which anything placebo ... is evaluated with a fine tooth comb and there we're talking little white tablets... The prospect of using a surgical approach I think raises the stakes enormously" (MREC 3)
"...I would think that in conclusion it's probably the general anaesthesia that will cause ethics committees the most problems because then they will say now is this really too much of a risk to be giving somebody a general anaesthetic for nothing... I can see everybody say, 'Oh oh no way, not general anaesthetics'" (MREC 1)
" ... I'd want a very robust justification for tackling the equipoise in this rather risky, in this potentially risky way. I think any self-respecting Committee that is the question they would ask. I would certainly be weighed by what risks our anaesthetic colleagues thought fair. I mean you've got to, you can't negate the risk... If the study is going ahead, there is a risk, you can't negate it. I think I'd want evidence that the risks had been fully considered and minimised... my experience is [that] anaesthetists are a very ethical lot indeed... and they serve as a very useful counterbalance to the surgeons ...I can see the surgeons are faced with people in awful, intractable pain and they want to do something about it" (MREC 4)