Study aims and objectives

The study aimed to gain insight into the views and opinions of healthcare professionals about the drugs being tested in the CONSTRUCT trial (ie, infliximab and ciclosporin) and their personal contribution to the trial. Specific objectives were to examine how drugs were administered, their perceived ease of handling, professionals’ personal drug preferences and views on colleagues’ drug preferences, and equipoise in recruiting to the trial.

Drug administration and management

PIs and nurses, when asked about the administration of infliximab and ciclosporin, were keen to point out that consideration must be given to the administration process as well as to the lead-up procedure: ‘workup to treatment’ (PI, Recruiting well to cohort but less well to trial). Patient workup was seen as a vitally important step in administering the drugs. However, workup was said to be something that was neither given enough consideration within the drug guidelines, nor discussed in terms of its effect on the rest of the administration process, such as its effect on drug handling. Interviewees described the workup as necessary for the provision of infliximab and ciclosporin in similar terms; however, following initial workup, administration of infliximab was much easier to handle than the administration activities necessary for the provision of ciclosporin. First, there was less to be concerned about during that period of time and second, the process had less impact on workload, especially for nurses, while both drugs demanded due care and attention. Attention to detail was described according to: the careful mixing of drugs and other preparations necessary for treatment, prescreening of patients and patient preparedness for the intravenous infusions. In this respect, ciclosporin was consistently described as the more complicated of the two, with a longer administration time (continuous infusion as opposed to 2 hours for infliximab) and with the need for frequent changes of intravenous bags (infliximab is a one-off infusion). This had a knock-on effect on healthcare professionals’ work schedules: see Q1 and Q2.

Nurses’ views accorded with PI opinion on this matter. In addition, nurses were keen to emphasise the complexities resulting from contextual and geographical factors that had to be contended within a busy hospital setting, such as managing patients on different wards or requiring an infusion, and as a consequence the need for a greater number of nurses with advanced prescribing capabilities on the wards at any one time: see Q3.

The practicalities of a lengthier ciclosporin infusion had implications for patients’ well-being too, with health professionals having to spend more extensive periods of time in hospital dealing with patients who were: ‘frustrated’ (Nurse, recruiting well) with highly restricted movement: see Q4.

Views on the ease of administering individual drugs were clearly influenced by an individual's familiarity with the drug in question. Thus, those with more experience of ciclosporin tended to be more positive about that drug, and they suggested that nurses should be trained in both drugs as they faced a steep ‘learning curve’ (PI, recruiting well), particularly in relation to ciclosporin. Nevertheless, support for the administration of infliximab was more strongly felt and it was repeatedly described as the ‘easier’ (PI, recruiting well) and more ‘convenient’ (PI, recruiting well) drug: see Q5.

While both drugs were perceived to be effective, ciclosporin was faster-acting, and offered a clearer patient response timeline. Infliximab, on the other hand, presented a challenge in terms of whether to continue with it or look for a different treatment. Ciclosporin was more ‘clear-cut’ (PI, recruiting well) and PIs felt more confident in their decision-making and timing around prescribing this drug. In addition, PIs worried about the limited information available for infliximab response rates, as this did not appear to match patients’ actual responsiveness, made all the more complex by the need for an extended administration period: see Q6 and Q7.

In addition to response times, adverse effects were of major importance in treating patients with one drug or another. Ciclosporin, in particular, was seen to have a range of associated adverse effects, which included: drug toxicity, renal failure, neurological impairment, seizures, tremors and hypertension. PIs were ‘uneasy’ (PI, recruiting well) about the drug, seeing it as ‘dangerous’ (PI) poor overall recuitment. Even those advocating its use tended to be apprehensive about the adverse effects in the longer term, viewing it as more of a bridging therapy. These views were reinforced by a perceived lack of evidence of ciclosporin's longer term benefits. See Q8 and Q9.

An adverse risk profile for ciclosporin was described as resulting in increased patient monitoring and checking of drug and blood levels, which, in addition to a more resource-intensive process, impacted on nurses’ time. This is particularly noticeable on a busy ward where there are difficulties with nurse–patient ratios, and nurses had the sense that their profession was struggling with workload increases. This impacted on their ability to give equal time to all patients under their care. They reported occasionally: ‘forgetting’ (Nurse, recruiting well) to monitor patients on ciclosporin. Infliximab, on the other hand, did not warrant any additional monitoring following inpatient discharge and no issues associated with monitoring were raised: see Q10 and Q11.

While infliximab also carried a risk profile that included adverse reactions, causing particular hesitancy in prescribing it for the older patient, it was favoured for its perceived fewer side effects and longerterm efficacy: see Q12 and Q13.

However, PIs pointed their frustrations with policy restrictions and Government guidelines that prevented the use of infliximab in the way they wished, including the need to justify its use in the longer term: see Q14 and Q15.

Personal preference and trial involvement

PIs clearly recognised the effect that their own experience of using one drug or another had on their personal preference. While many were equivocal, some PIs expressed a clear preference for infliximab over ciclosporin based on its ease of preparation, easier administration, lower negative impact on nurse care provision, staffing and workloads, longer term benefits and reduced adverse effects. In addition, both PIs and nurses pointed to greater patient tolerance and enhanced patient convenience. Further reasons for stated preferences included: familiarity with the drug, drug effectiveness, greater clinical expertise and knowledge, and a general sense of ‘unease’ (PI, recruiting well) with the use of ciclosporin: see Q16 and Q17.

Nurses’ views were similar to those of their consultant counterparts, expressing a preference for infliximab based on its ease of administration, perceived patient benefits and personal experience and familiarity with the drug. They highlighted the restrictions of patients being hooked up to a ciclosporin infusion for longer periods of time while suffering from bowel disturbances, and noted patients’ preference for infliximab in this respect. Ciclosporin was described as ‘high maintenance’ (Nurse, recruiting well): see Q18.

Two PIs described a preference for ciclosporin, based on personal familiarity with the drug, its quicker-acting properties and its ability to disappear from the system once the drug administration had been halted. However, even these two interviewees stressed the need to retain a level of vigilance—to ‘be more wary’ (PI, poor overall recruitment): see Q19 and Q20.

In spite of these personal preferences, there remained a genuine sense of uncertainty as to which drug was the more beneficial at the time of the trial, particularly in relation to people's views of trial entry, trial management and patient recruitment. Most healthcare professionals commented that the relative effectiveness of the two drugs was unclear, genuinely wanting answers from the trial team as to the ‘better’ (PI, recruiting well) of the two. This desire was described as patient-driven, based on which of the two was most effective and well received by patients: see Q21 and Q22. All professionals expressed contentment to suspend preferences within the CONSTRUCT Trial and recognised the importance of establishing relative effectiveness and safety.

Professionals welcomed the CONSTRUCT trial, and congratulated the trial team for moving this body of work forward so successfully. They discussed the fact that they had attempted to actively recruit patients into the trial, despite, in the lower recruiting sites, a lack of success, which was put down to busy workloads and lack of joined-up working patterns.

Policy development and drug regulation

Healthcare professionals were clearly aware of the higher cost of infliximab, and saw implications of this driving policy development and guidelines for practice. Guidelines around the use of the drug ultimately affected clinical decision-making: see Q23.

While healthcare professionals understood the need for rigorous guidelines around the use of the drugs, they also linked guidelines to an enforced restriction of the use of infliximab, arguing that the NICE guidelines (referring to TA140)21 were outdated, outmoded and out of step with more recent evidence. This left them, as a body of healthcare professionals, feeling frustrated and constrained in their ability to provide the best and most appropriate care for their patients. They described having ‘their hands tied’ (PI, poor overall recruitment), and believed that the more recent clinical evidence and their own personal experience indicated infliximab as the drug that needed to be used more widely. As a consequence, they urged that guidelines become more flexible in order to accommodate patient needs more appropriately: see Q24 and Q25.

The point was repeatedly reinforced. While the guidelines were there to be adhered to, there was a clear sense of rebellion within the profession, with clinicians ‘ignoring’ (PI, recruiting well) guidelines to meet patient needs, in order to administer infliximab. Thus healthcare professionals welcomed a much-needed change to the guidelines that allowed for greater flexibility of drug use, led primarily from an assessment of patient need: see Q26.

Patient benefit and negotiated care

Underpinning discussions around the administration of the drugs, treatment of patients, personal preference, and adherence to guidelines and regulations was a professional focus on patient benefit and need. Nurses and PIs gave many examples of the decisions that took account of what was best for the patient, especially when it came to a consideration of the patient's personal circumstances: see Q27 and Q28.

Nurses appeared more influenced than PIs by the patient experience, perhaps as a result of their extended contact with the patients, indicated by the fact that nurses always discussed their preference in the context of patient convenience and quality of life: see Q29.

As evident in quote 29, the notion of negotiated care was central to the consultation as far as nurses were concerned and ongoing patient care, and decision-making was perceived as a shared practice across and within multidisciplinary teams. This led to a shared professional responsibility, while the patient–clinician interaction came across as the ultimate example of this: see Q30, Q31 and Q32.