During the trial participants unfortunately experienced problems in obtaining GP appointments as recommended in the one page action plan. Our focus group feedback illustrated that obtaining GP appointments has become increasingly difficult due to staffing issues. Rather than increasing confidence and self-efficacy in caring for themselves the BET intervention may only have increased frustration when participants were unable to access the care recommended. The need to unify the bronchiectasis treatment pathway and hence support for patients requires further research.
Literacy
Literacy is a matter of importance within BET and its evaluative study. Minimising displacement for participants meant using patient reported outcomes (PROs) in the form of written questionnaires. The patient-held information within BET was also largely written with tabular tracking sections to complete. Illness and wellbeing beliefs affecting patient reported outcomes are explored below. The level of literacy of its participants was not evaluated in the BET cohort. Participants were asked, as part of the collection of demographic information for their highest level of academic attainment.
One hundred and ninety three participants (88%) responded to the question of the two hundred and twenty participants who consented to take part in the study. Of those respondents fifty-five reported no qualifications (25% of participants). One in six people in the UK have literacy below that expected of an eleven year-old (402).
In addition to issues of literacy the questionnaires (PROs) had multiple different measures and formats that our patient research ambassadors noted to be confusing. This may have contributed to attrition (Appendix 18).
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Culture
Self-management is about adopting behaviours to promote health. Behaviour is culturally informed but there is a paucity of information relating to the impact of culture on health research (403). People with chronic disease frequently minimise symptoms, through habituation, in order to accept and move on with every-day life and to adapt psychologically to living with disease (404). Adaptation to bronchiectasis and habituation to physical and emotional hardships may minimise the impact on quality of life reported using patient reported outcome measures (405). Refusal to take part in trial measurements during a trial visit is unusual. However, we live in an ‘evaluation’ culture where all services seek feedback, this overwhelming demand may result in rebellion and refusal to complete mailed questionnaires.
Emotions
People with chronic respiratory symptoms commonly suffer from anxiety and depression, these in turn affect outcomes of educational interventions (406). Depression has impact on motivation which may assist in explaining attrition rates and failure to return questionnaires.
Attitudes
Attitudes to research affect patient choices to participate in clinical trials. An Irish paper published in 2016 (407) described a paucity of evidence available on the topic after identifying that at the local research facility two hundred and ninety one participants only were recruited from a catchment area of 1 million. Two hundred and fifty thousand of which had attended hospital once within the past year, meaning less than a half of one percent participated.
The local hospital site from which the greatest number of participants were recruited for BET provides tertiary care for a catchment of 822,500 (408) and recruited 4933 (409) research participants in the year 2016 to 2017 representing less than 1 percent. Patients living in Norfolk receiving information relating to research frequently ‘ask permission’ of their General Practitioner or secondary care consultant.
Page 183 of 288 In the BET trial there is a steep withdrawal of participants after their initial consultation. This may be the point at which participants internalised the personal effort involved in completion in comparison with the small amount of inter- personally delivered education received.
It is not known why, though it may be due to a realisation of what is actually involved, a feeling that they have discharged their responsibility merely by agreeing to take part or due to an underestimation of the burden of their disease and its effect on their ability to complete trial requirements. Attitudes to individual responsibility within chronic disease vary widely (410) these also affect people’s perceptions of whether they are able to change their health behaviours illustrated in the diversity of observed behaviours discussed in chapter 8 relating to roles and interaction with health professionals (411).
Socio-economic standing
The fact that deprivation and low literacy are linked is substantiated by Baker et al. (412). Aaartsen et al. go further in establishing the influence of socio-economic position and health in which lower economic standing is a predictor of reduced longevity and poorer health (413). Lower levels of educational attainment frequently mirror economic standing acting as a barrier to research participation.
Data treatment
It is viewed as good practice to apply intention-to-treat principles to clinical trials in order to reflect more closely the uptake of the actual population if the intervention were to become practice.
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Name of the intervention and cover photo
During the education some participants shared their fear that the ‘tool’ part of the Bronchiectasis Empowerment Tool might be a drill or other painful medical implement.
This surprise finding had not occurred to our patient and public advisors (perhaps due to oral introduction preceding document review). In addition the participants did not identify with the cover photo (Appendix 20).