Methods

A comprehensive process of logging of potential RCT participants through screening and eligibility phases was put in place in order to ensure compliance with the CONSORT checklist. These data were made available to the qualitative researcher (AR) on a regular basis to facilitate monitoring recruitment. These data and interviews with the different recruitment teams helped to develop a flow chart of the most likely patient pathways.

Results

Figure 8 presents a flow chart summarising the patient pathway. It was important to assess patient pathways in relation to their complexity and compliance with the protocol as well as variation between centres. This information provided indications of particular points where patients could potentially be ‘lost’ from the RCT.

FIGURE 8

The FASHIoN pathway through eligibility and recruitment.

Methods

In-depth, semistructured face-to-face interviews were conducted with members of the TMG, including the chief investigator and those most closely involved in the design, management, leadership and co-ordination of the trial.

Informants were asked about the background, development and purpose of the RCT; their knowledge of the evidence and their own opinion or equipoise; their role in the trial; and their expectation of the pathway through eligibility and recruitment. They were also asked to provide a short verbal summary of the RCT for the interviewer, as if AR was a patient.

Interview topic guides were used to ensure similar areas were covered in each interview, based on those used in previous studies,²⁷ but also encouraging the informants to express their own views about the RCT and any recruitment challenges expected or experienced (see Appendix 10).

Transcripts of the interviews were analysed thematically by AR, using techniques of constant comparison and case study approaches. This involved detailed coding and then comparing emerging themes looking for shared or disparate views among TMG members. The coding was carried out using the qualitative data analysis software NVivo. The initial coding (AR) was checked by two other QRI researchers (AA and JD) and inconsistencies resolved by discussion. Detailed descriptive accounts of the themes and cases were produced.

Results

Ten interviews were conducted with members of the TMG. Analysis of these and observation of the TMG meetings showed the group was formed of four subteams with specific functions:

1. orthopaedic surgeons and senior physiotherapists in charge of designing the interventions, recruiting participants and offering a critical view of the research procedures
2. the trial administration and finance control group dedicated to data management, liaison with other agencies, and finance planning and expenditure
3. expert statisticians in charge of designing and planning statistical analysis
4. qualitative researchers in charge of the QRI.

Members of each subgroup had at least three different levels of involvement with the research. The first one was with the day-to-day running of the trial; at a second level, senior members supervised tasks and made major decisions (e.g. TMG meetings); and, finally, some members of the team remained distant from the trial procedures and provided a critical assessment of the trial and/or consultancy in particular aspects of the research (e.g. statistical analysis).

The team members showed an adequate knowledge of the trial protocol according to their level of involvement. Clinicians were the most knowledgeable as well as those involved with everyday activities, which was as expected. Task delegation within this multidisciplinary team prevented recurrent role conflicts and helped the team to develop ‘collective equipoise’. This term refers to the tendency of the team members to challenge each other’s expectations about the results of the RCT without favouring either of the two treatments tested. For example, although it was likely the orthopaedic surgeons running this trial tended to advocate for the operative treatment of FAI, they had a strong background in research and, therefore, were able to suspend clinical judgement and achieved a balanced view of the treatments that were compared, as illustrated by the following quote:

I distinguish there between my sort of gut feeling and my instinct. My instinct is that it works, surgery works [. . .] However, I do recognise that I have also seen it not work and I recognise that the evidence that supports it working, even the evidence I’ve generated myself, is methodologically weak and therefore I think that a scientific and objective perspective of the evidence [. . .] I am therefore an equipoise so I’m able to hold two views on it. And obviously, I mean the equipoise view is the one that I use when I’m involved in a trial.

TMG01

As a result, the team sought collaboration with physiotherapists at national and international levels and developed a credible conservative care protocol. Additionally, the TMG included professionals without expertise on hip arthroscopy or physiotherapy that facilitated equipoise.

A major concern for the TMG was the multicentre aspect of the pilot. They mentioned challenges such as difficulties implementing and overseeing procedures in other centres, delays in setting up, low numbers of eligible patients and lack of equipoise in research teams. The following quotes exemplified these concerns:

I know that the start of some of the sites has been a bit delayed but that is not unusual nor is it surprising given the complexities of setting up research in different sites.

TMG05

I’ve got major doubts [the study will be successful]. I think it was entirely the right thing to do it as a feasibility study, I have serious concerns that we won’t be able to recruit outside of this centre [. . .] Finding that surgeons and patients at the same time have both got equipoise is just going to be very difficult.

TMG02

Among the suggestions collected from the group to address the concerns were:

• regular visits to the centres by the PI and other TGM members to keep momentum
• delivery of a slick and easy-to-implement recruitment process in order to be the least disruptive to routine clinical practice
• providing frequent and comprehensive training to recruiters helping them to develop skills and confidence (e.g. role playing, FAQ, peer support, etc.)
• modifying the support to teams in other centres according to their research experience
• setting recruitment targets and engendering a healthy competition between centres
• sending regular newsletters providing information about recruitment.

Methods

In-depth, semistructured face-to-face interviews were conducted with clinicians and research associates tasked with recruiting patients in visits to sites soon after they had started to recruit patients for the pilot RCT.

Informants were asked questions about their knowledge of the evidence for the treatment of FAI and their personal views about equipoise; the recruitment pathway; how they feel the protocol fits their clinical setting; and any adjustments they thought were needed to the trial procedures. They were also asked about the audio recording of their consultations with patients, with a view to discussing any discomfort or perceived difficulty with this.

Again, interview topic guides were used (see Appendix 10) and informants were encouraged to express their own views about the RCT and any recruitment challenges expected or experienced.

Analysis was as for the TMG interviews, but themes were also explored to examine differences or similarities between the TMG members and specialist clinicians and recruiters, and within or between centres or clinical specialties.

Results

Twenty-one interviews of clinicians and research associates were performed at eight participating sites. Common concerns and good practice examples were identified across the transcripts and were organised in the following themes.

Methods

The chief investigator and TMG decided that the meeting in which randomisation was discussed, the ‘recruitment consultation’, as well as the prior appointment when the patient was told their diagnosis of FAI, ‘diagnostic consultation’, represented pivotal points of the recruitment to this trial and, therefore, sites were asked to record these two consultations for each potential trial participant.

The importance of audio recording discussions about RCT recruitment was emphasised at site initiation visit. All participating centres in the pilot RCT were asked to audio record recruitment and diagnostic consultations when appropriate and feasible. One main point of contact (usually the research associate) was identified per centre and digital audio recorders were provided. PISs and consent forms for audio recording and instructions for the operation of the recorder, dictation of patient/recruiter/recording identifiers, naming and transferring of the recording to the computer and then to the QRI team were provided to centres. Clinicians were assured the feedback to them was going to be confidential and positive (not critical). Prior to their consultation with the surgeon, patients were approached and the PIS for the audio recording of consultations was given to them to read. Once their questions were answered and if they agreed to the audio recording, patients were then asked to sign a consent form.

Audio recordings of consultations were analysed following thematic analysis and some of the techniques of focused conversation analysis pioneered in previous studies (Donovan et al. 2003;²⁶ Donovan et al. 2009²⁷). The analytical techniques were used to identify and document aspects of informed consent and information provision that were unclear or disrupted or which hindered recruitment. The content of the appointments was evaluated, including what basic content was covered, the order of presentation of RCT arms and other treatment options, time spent on interventions and time spent describing both the RCT design and the randomisation process. Furthermore, an assessment was made as to whether or not the recruiter listened to patients’ concerns and addressed them and also the degree to which there was evidence that the participant understood the key issues of equipoise, randomisation, participation in the RCT, the option to choose their treatment and the option to withdraw from the research at any time.

AR documented these details and provided an account for JD and AA. When at least three recordings per recruiter had been analysed, the QRI researchers decided what confidential feedback would be given in order to promote research associates’ communication skills development and recruitment effectiveness. Issues to be fed back to the RCT chief investigator/TMG, or to be used anonymously in training programmes, were discussed and defined.

Results

Eighty-seven diagnostic and recruitment consultations relating to 60 individual patients were recorded and analysed. A subset of eight successful and 13 unsuccessful recruitment consultations were studied in detail in order to understand communication patterns that were linked to improved recruitment rates and which could be repeated in future patient approaches. The remaining audio recordings were used to validate the best recruitment practice model (see Figure 9) and create personalised feedback for recruiters who had submitted the recordings.

FIGURE 9

The FASHIoN model of a good recruitment consultation: a six-step approach.

Qualitative recruitment intervention support focused on three sites where recruitment was comparatively low (42–66%).

Common problems identified were:

Unbalanced presentations of treatment options, for which surgery has been presented at greater length and more favourably than either choosing conservative care or participating in the RCT (surgeons tend to talk most about what they are most familiar with). The following quote illustrated this information unbalance:

There are other centres and other people have shown physiotherapy to be very useful. It has to be quite specialist, quite bespoke physiotherapy and the chap here from W [Warwick] University today has actually come down to recruit patients to a trial. The overall sort of duration of therapy is roughly around sort of 6 months for both of them to have their benefit, so it’s a similar timescale. Obviously the operation has small risks attached to it. There’s a very small risk of serious nerve injury, I mean it’s less than half a per cent, but, you know that’s the main concern with keyhole hip surgery, because we have to put the leg on traction in order to get in to the hip joint. And sometimes people’s nerves do not like being pulled upon, but that is very rare. We’ve had 2 cases at this hospital in around about 1000, so you know it’s a rare complication. A little bit of wound infection is a possibility, a little bit of bleeding, blood clots, things like this. They are all theoretical risks; they all seem to be quite low for keyhole surgery, so nerve injury is the only sort of serious problem that we’ve experienced. You can get a bit of numbness of the outside of the thigh because of the skin nerve that can get pranged because it’s near one of the portals. So these are the kind of downsides of surgery. So you know those are the two options available and I think you’re a good candidate for either one.

PI8

Graphic descriptions of surgery that may have put patients off randomisation; for example, one clinician explained:

There’s always a risk from the traction that it may stretch the nerves down the leg, so that could leave you with some numbness. If you’re very unlucky it could leave you with a little bit of weakness there.

PI4

Presenting trial information in an order that is confusing for patients, which is illustrated in the following quote:

OK, and I’ll probably bring [surgeon] in to explain more about the pros and cons of each of the treatments. Mr [local surgeon] would do the arthroscopy, but for the purpose of the study, we ask people if they’re happy to do it, and either of the treatments is chosen for you. So a specialised programme, a computer programme will choose the treatment of your . . . that you will receive.

SN004

Surgeons going beyond their protocol brief, to explain the trial rather than referring patients on to the trial recruiter for this information; this is illustrated in the following quote in which the surgeon has already discussed and agreed on a treatment before calling the researcher:

Surgeon:

So I’m going to recommend that we (drilling continues) err, at least consider looking inside your hips.

Patient:

Yes.

Surgeon:

If you’ve got a moment, I would appreciate if you have a chat with P, who’s the researcher.

Patient:

OK.

Surgeon:

And just see if the study appeals to you. But you don’t have to, there’s no pressure, you don’t have to be enrolled in the study.

SN008

Conversely, surgeon endorsement of trial participation to patients appeared to have a positive impact on recruitment.

Previous research has shown that, in general, one in four people decline to participate in a RCT despite high-quality recruitment practices because of strong patient preferences or treatment refusal. The recruitment rate for the FASHIoN study was 70%, which suggested processes of informed consent and participant self-selection were working well. Therefore, identifying what worked in the recruitment appointments was relevant in order to replicate recruitment practices in the full trial.

A model of a good FASHIoN recruitment consultation was developed based on communication patterns identified in the observation of successful recruiters and the comparison and contrast of these patterns with the ones observed in unsuccessful recruitment consultations. Aspects such as sequence of presentation, balancing the time and level of detail of the treatment discussions and the sufficiency of explanations about the trial procedures were addressed. Figure 9 shows the stepwise approach to a good a recruitment consultation that has been developed based on the analysis of the audio recordings collected during the FASHIoN trial.

The main principle underpinning the model is that recruitment consultations are different from clinical consultations in that they should enable patients to understand uncertainty and lack of clinical research evidence. In routine clinical consultations, clinicians and patients may be dealing with many uncertainties at the beginning, but these are soon resolved through the interaction and when a decision about treatment options is made. The direction of the clinical consultation is from uncertainty towards decision-making, while in recruitment consultations the sequence of information sharing starts from stating what is currently known about the treatments and moves towards uncertainty. During the observation of successful recruitment consultations, a logical sequence emerged which achieved this purpose and is explained next.

Step 1: explain what femoroacetabular impingement is to the patient

The first step in the recruitment process is the diagnostic consultation. In successful recruitment consultations, patients received an explanation about FAI that was easy to understand. Clinicians tended to use lay terms to illustrate what happens to the body because of this condition (e.g. ‘shape abnormality’, ‘egg shape’, ‘extra little piece of bone’, etc.). They also made use of metaphors from common everyday experiences, for example piston heads in a car, as illustrated by the following quote:

If we imagine a car has a piston that’s not smooth, yours, your hip joint is like a, sort of a joint that’s not completely smooth and so when you try to move it, it’s causing damage to and pain in your hip joint.

SN034

These attempts to make sure the patient understands what it is happening to their bodies are important investments in the relationship and helped patients to feel confident in the care they were receiving. In addition to the ‘shape abnormality’ explanation of FAI, successful recruiters also introduced the role of muscle control in the diagnosis of FAI. This information permitted patients to make a logical link between the condition and the PHT as a plausible treatment, which could be utilised later in the discussion. Many recruiters expressed their concern about not being able to justify why physiotherapy could be effective. This explanation addressed this concern; for example, a surgeon summarised it as:

My idea on this is if you’ve got the egg shape, and your muscles are not good at supporting it, then you run into trouble.

SN053

Surgeons also introduced the common incidence of this condition in the population, which supported the sense of urgency about answering the research questions and increasing the available knowledge about FAI.

Step 2: reassure the patient that they will receive treatment

Patients who agreed to participate in the trial were reassured their diagnosis was confirmed. They were also reassured they would receive the best treatment to meet their individual needs, whether they agreed to be in the trial or not, as illustrated in the following quote:

You’re getting a bit of extra rubbing. And that rubbing is causing the pain, so there’s not really any mystery, we know what the problem is [. . .] my suggestion is that we treat this problem; I don’t think we should just leave it alone, I think we need to try and make you better.

SN034

This was important because many patients waited for a long time to reach the appointment with the surgeon and may have been previously misdiagnosed. Patients may arrive at the clinic dissatisfied with the treatment they received so far. Often patients who declined to be part of the trial have experienced these difficulties. Being told that finally they have the right diagnosis, that someone is confident about it, generates trust and openness to the invitation to help improving care for other patients like themselves. This step addressed the previously identified concern that the treatment allocated to them is not taking into consideration their personal circumstances and their individual needs for care. A direct invitation from the consultant surgeon to the patient about participating in the trial seems particularly effective in getting the person to consider the trial and to listen to the recruiter; an example is presented in the following extract:

And in a minute, one of my colleagues, if you agree, will come and talk to you about how that particular study is working. And, if you would like to, I would very much like to include you in that study?

SN053

Step 3: explain that there is uncertainty about which treatment is the best

Steps 1 and 2 promote certainty, whereas step 3 is about introducing uncertainty. In successful recruitment consultations, uncertainty was mentioned earlier on and by the consultant, and then it was reinforced repeatedly by the recruiter during their appointment with the patient. Even in effective recruitment consultations, recognising uncertainty may be difficult for patients. Effective recruiters enabled the patient to understand that the two treatments that were being compared are effective in their own right. This argument helps to compensate for the uneasiness of not knowing which treatment is best. The following extract of a diagnostic consultation exemplifies this step:

Consultant:

I think we can offer you some treatment for it, but the trouble is we’ve only really just started to understand this disease [. . .] we’ve got two treatments that we know can help, but we just don’t know which is the better one.

Recruiter:

What we’re doing is, as [the consultant] has explained, we don’t know which is best, we’re not sure. [Consultant], myself and any of the other consultants that specialise in hips here, can’t tell you. For you, I think the best thing to do is X or Y because we don’t know.

Patient:

You don’t know what the best treatment is?

Recruiter:

Well, we need people like you to say, ‘OK, I’m happy to take part, and whichever treatment I get then I should, should get a little bit better’, but one will be better than the other probably.

SN034

Step 4: explain the purpose of the study

Once uncertainty was been explained, the purpose of the study follows logically. Recruiters stated how the findings of the research would help clinicians to advise patients like them in the future. At this point, successful recruiters mentioned the need for evidence, implying the real contribution to advancing science and health care that patients could make. Recruiters were successful at harmonising the message that FAI is a condition that clinicians are interested in knowing more about how to treat and the message that patients would be valued, respected and cared for during the trial. An example is presented below:

[The recruiter] can explain the study to you, and explain how we try and find out the answer to the question and how you might get involved in that. One thing though, is whatever we do, and I’m going to do everything I can to make you better.

SN006

Step 5: give the patient a balanced view about the pros and cons of each of the two treatments

In some cases, the recruitment consultation was introduced as a conversation about the options available to patients. For example, one surgeon said:

[Recruiter] is doing a study looking at the different solutions and he could talk to you about the options if we got to the point where you said you’d like to do something about it.

SN007

Instead, some successful recruiters and clinicians avoided the word ‘options’ when referring to the treatment arms of the RCT because it implies there is a decision to be made between the two treatments, whereas the patient has to decide between being part of the trial or not. Alternative expressions such as ‘available treatments’ or ‘ways to treat FAI’ were used, providing a clearer message. In effective recruitment consultations, the treatment arms were presented as two ways of dealing with the same condition. Recruiters spent similar amounts of time explaining each one of the arms. They tended to start with the non-operative arm and the balance between the two treatments was maintained when talking in detail about the benefits and risks of each arm (e.g. number of visits to hospital for each arm, duration of the intervention). For example, a recruiter discussed the balance between arms as:

The kind of use of your time is equal, whichever one you go for, whichever one you’re allocated to . . . The reason I say that is because if you have an operation you have to come for a pre-operative assessment, you have to have the operation and you have to have some rehab. If you’re allocated to the personalised hip therapy, you’ll have to come here on three, at least three occasions, and then they’ll give you specific exercises to practise at home.

SN034

Effective recruiters also emphasised the benefits of the two treatments in order to assure patients they were not taking any more risks than if they were making the choice themselves. After step 5, patients usually were not sure what treatment to choose. They may have thought about having one treatment at the start of the conversation, but at this point, they expressed either the opposite choice or simply uncertainty about which one to have. Patient equipoise was thus achieved.

Step 6: explain the study procedures

Once uncertainty and equipoise were established, the allocation of treatments by randomisation seemed more acceptable. Randomisation was mentioned later on in the conversation and recruiters spent a lot less time explaining it than the time they spent on the other steps. Randomisation was usually presented as an allocation or being invited to join one of the groups, which should allow a fair comparison. The following quote exemplified this explanation:

But in order to make it a fair test and in order to make sure that we’re truly, truly testing which one’s better, we have to go through a process whereby we allocate you with a treatment. So I don’t choose and [Professor] doesn’t choose and we don’t choose which, which treatment you have . . . it’s randomly allocated to you

SN003

The questionnaires and the reassessment after a year were constructed as part of a closer follow-up of participants in the trial than for people going through regular care. This was part of the efforts of the recruiters to emphasise that patients would be treated with respect and receive personalised care.

Two more tasks were added to the model. They are not a fixed part of the six-step sequence; instead they happen at different points throughout the most successful consultations. These two tasks appeared to be essential and determinant in the successful of a recruitment consultation.

Task 1: respond to patients’ concerns and questions

The majority of patient questions occurred after the two treatments were explained. Often patients wanted to know about the details of each arm and the rationale for the non-operative arm. Successful recruiters stopped delivering information and answered the questions or listened to patient concerns before moving onto the next step. The conversations in the most successful recruitment consultations were highly patient-centred, with evidence the clinicians were responding to the patient’s concerns and doubts about the trial. Patients asked more questions than in unsuccessful recruitment appointments. Recruiters confirmed that patient participation was voluntary and that patients would receive treatment regardless of their involvement with the study, which encouraged trust.

Task 2: show confidence and a relaxed manner

Effective recruiters appeared confident and relaxed when talking about the study. This was based on having a good working knowledge about the condition and the treatments or taking actions towards achieving it. In addition, successful recruiters used a set of ready-made answers to common patient questions prepared by the TMG and worked closely with the clinicians in order to deal with tricky questions.

The model structure is identical to the approach used in the PIS. Therefore, giving the patient the opportunity to read this document at the beginning of recruitment could save time dedicated to information sharing. Instead, this time can be used to respond to patients’ concerns, showing the balance between risks and benefits between the two trial arms, reassuring patients about participating in a trial, explaining the condition in more detail or discussing uncertainty. Feedback to the sites was prepared based on this model and presented to the recruiters and PIs (see Evidence base for the trial). Further data collection continued to be used to develop and validate the model.