Interview participants had different levels of understanding about the concept of randomisation and what would be involved in the randomisation process, although it had been explained to them before asking for their consent about participation. Some participants had clearly understood that they were randomly assigned to one of the trial arms and the meaning of using this approach. Others were less clear in their understanding of it.
The 52 year old female participant who had nine years of education level reported how she understood randomisation: ‘Randomisation is something to be done in random order ... For example input all of patients' names into
a computer and ask computer to randomly assign them into groups... It is
a bit like gambling or lottery. You have no idea who will be in which group,
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follow and is entirely accidental’ (58UC). Although she was in the usual care group and did not get the leaflet she wanted, she believed randomisation could ensure the participants’ allocation to be fair because that who was in which group was not decided by someone but a computerised process.
Some participants held similar views about randomisation as something beyond human control (203PE, 214PE and 60UC). They believed that it was arranged by fate as to whether they would be allocated to the preoperative education group or not, and that the possibility of getting into any group for everybody was equal. One 23 year old man (203PE) put his explanation of the randomisation process more simply by saying that, ‘I know I have a 50% probability to be assigned to either the control group or leaflet group.
I totally understand this is your study requirements.’ Not all patients grasped the concept of randomisation. Several participants explicitly stated that they were not quite clear about what it was. One male participant (60UC) who got a bachelor degree said, ‘I knew a little. I was not clear actually. But I knew randomisation must be a good way to do your
research.’
Only two interview participants explicitly stated that they would not mind which group they would be allocated to (60UC and 214PE). The majority of participants described their preference for being allocated to the preoperative education group (254UC and 255PE) as they expected more information and support in this group and desired to see the leaflet. However, they further explained that although they had a preference they would like to keep complying with the study because they understood having two groups was a basic feature of the study design.
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All interview participants indicated that they understood what was required of them in the study from the day they signed the consent form. The participants from the preoperative education group stated they had not shared the leaflet with others, while those allocated to the usual care group denied having seen the leaflet. Only one man (53PE) from the preoperative education group mentioned that he was given a leaflet after he had read it from another patient in the same room. From his story, it was apparent there was some contamination between the two groups.
Interview participants felt lucky and pleased to be involved in the study. Most participants, when asked if they would change any decisions they made in relation to the participation, stated that there was nothing they would change and furthermore they would like to recommend joining the study to other patients.
7.7 Summary
The qualitative evaluation provided valuable insights into the content, process and context of the intervention implemented and a deep understanding of patients’ experience of taking part in the trial. It helped to answer the questions regarding why and how the preoperative education intervention worked or not and how it could be improved. Regarding the process of information giving, participants spoke about the hierarchy of hospital staff and how information was judged on the basis of the reputation of its source. A number of interview participants expressed their wishes to get more information about possible risks and complications before surgery to enable them to have a better understanding of cardiac surgery. Role models were highlighted by some participants who commented on the need for mutual learning and peer encouragement. This
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helped to develop a sense of a shared experience and brought comfort from the feeling that participants were not alone.
Many participants noted that information giving by ward staff was generally one way, reactive rather than proactive, and limited, and patients were not fully engaged. This was often attributed to the staff’s heavy workload. The majority of interview participants who had received the intervention felt satisfied with it. Participants believed that the leaflet combined with verbal explanation helped them remain calm, be better prepared for surgery and take an active role in health care.
The context of information giving helped shed a light on possible factors influencing the delivery of preoperative education. Reflecting patients’ increasing demand for information about health care, they had gathered from various sources advice and support before surgery to help them make important decisions. A few participants explained that they really have understood the importance of information on building up their inner strength to face surgery. Information giving and psychological support were considered a low priority, compared to other treatment and care in China. Some participants mentioned that they felt lack of knowledge before surgery. As a way of protecting patients, sometimes family members were informed but patients themselves were overlooked. All interview participants appreciated being involved in the study and most showed a level of understanding of the concept of randomisation. These findings are discussed alongside the trial results in the next chapter.
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CHAPTER EIGHT DISCUSSION 8.1 Introduction
The aim of this study was to test the hypothesis that a preoperative education intervention could reduce anxiety among cardiac surgery patients in China. A secondary aim was to examine whether the intervention could reduce depression and perceived pain, as well as length of Intensive Care Unit stay and postoperative hospital stay. The trial was carried out to test this, while a qualitative evaluation was conducted to explore the perceptions and experiences of patients who took part in the trial. In this chapter, the results and methodological strengths and limitations of the study are discussed. The findings from the trial and qualitative evaluation are integrated and discussed in the light of adult learning theory and are critically assessed in comparison with those from other studies.