1 Hypertensive patients’ perceptions of viewing ultrasound images of carotid
arteries: An interview study
Study Protocol
Contents
Page 1. Summary 2 2. Investigators 2 3. Sponsor 3 4. Centre 3 5. Background 4 6. Aims 6 7. Design 6 8. Participants and sample size 6 9. Inclusion and exclusion criteria 7 10. Informed consent 7 11. The interview 7 12. Data analysis 8 13. Ethical issues and risk assessment 9 14. References 10 Appendix I: Ultrasonography of carotid arteries Appendix II: Interview schedule 1 Version 1.1 19 December 2005 11
12 1. Summary
The aim of this study is to investigate hypertensive patients’ perceptions of viewing an
image of their carotid artery and how they respond to being able to see either the
presence or absence of atherosclerotic plaques which ultimately provides information
about coronary heart disease status. Hypertensive patients with at least one other risk
factor for coronary heart disease or stroke (i.e. raised cholesterol, being a smoker,
diabetes) are referred for ultrasonography of their carotid arteries and the resultant
images are then discussed with patients by their clinician at the next routine clinic
appointment. Patients who consent to the proposed study will be interviewed approximately one week after the discussion with their clinician. They will be asked
about their experiences of having ultrasonography and discussing the image with their
clinician and about their understanding of having or not having plaques in the carotid
artery. The interview will be audio-taped and transcribed verbatim. Anonymised
interviews transcripts will be analysed using interpretative phenomenological
analysis. The findings of this descriptive study will be used to generate hypotheses
that will be tested in a randomised controlled trial in the future.
2. Investigators
Ms Jane O’Conner
Postraguate Student
MSc in Health Psychology
University College London
Ms Eleni Mantzari
Postgraduate Student
MSc in Health Psychology
University College London
Dr Victoria Senior (academic supervisor)
Psychology Department
University of Surrey 2 Professor John Weinman (academic supervisor)
Institute of Psychiatry
Kings College London
Department of Psychology (at Guy’s)
Dr Albert Ferro
Kings College London
GKT School of Medicine
Cardiovascular Division
Guy’s Campus
Dr Soundrie Padayachee
Kings College London
Department of Ultrasonic Angiology
Guy’s Campus
3. Sponsor
This study is unfunded and is being conducted as part fulfilment for the degree of
MSc in Health Psychology at University College London by Ms Jane O’Conner and
Ms Eleni Mantzari. The research is being supervised by Dr Victoria Senior
(University of Surrey) and Professor John Weinman (Institute of Psychiatry,
Department of Psychology at Guy’s). The sponsor of the research is the University of
Surrey.
4. Centre
The study will be conducted at the Hypertension clinic for outpatients under the
direction of Dr Albert Ferro (Senior Lecturer in Clinical Pharmacology and Honorary
Consultant GKT School of Medicine) at Guy’s Hospital, London. 3 5. Background
Modern medical practice increasingly uses information about individual risk factors
and biological indices of disease progression in order to inform clinical decision
making for the purpose of primary and secondary prevention of disease. For example,
risk calculators based on Framingham risk scores are increasingly used to identify
patients with an increased risk of coronary heart disease (CHD) and establish ways of
reducing risk. In addition, clinicians also have at their disposal sophisticated imaging
techniques (e.g, ultrasound images, electron beam tomography) that allow them to
keep track of disease progression such as the existence of atherosclerotic plaques
which may ultimately lead to the patient having a myocardial infarction (MI) and
stroke (TIA). Chronic diseases such as CHD and TIA are determined to a large extent
by the behaviour of patients and whether they avoid risk-enhancing behaviours such
as smoking and engage in risk-reducing behaviours such as taking prescribed
medications as prescribed, eating a low-fat diet, and taking exercise. Over the past
couple of decades there has been an awareness that providing patients with
personalised risk information for CHD and TIA alongside information on how to
reduce risk may be a powerful way of motivating behaviour change and riskreduction. Despite this recognition of the potential value of giving patients such
personalised information, the evaluation of the impact of this information on
behaviour is in its infancy. A recent review of the impact of biomarkers (e.g.,
cholesterol level, genetic test results) on risk-related behaviour identified only eight
trials that met the inclusion criteria of the review (McClure, 2002). The author
concluded that whilst the preliminary evidence suggests that providing patients with
information about their risk status does indeed motivate behaviour change too little is
currently known about what information to present, how to present it, and how
patients themselves think about this risk information. In the present study, we aim to take a first step in investigating how hypertensive
patients respond to personal risk information about risk of CHD and TIA in the
context of viewing ultrasound images of their carotid arteries. Models in health
psychology of how people think about disease and threats to their health, such as the
self-regulation model of illness (Leventhal, Benyamini, Brownlee, Diefenbach,
4 Leventhal, Patrick-Miller, & Robitaille, 1997), suggest that viewing these images will
help patients to understand their risk of disease better. Patients are usually given fairly
abstract information such as their blood pressure or cholesterol level and they find it
difficult to understand how this information relates to what is happening inside their
body (Leventhal et al, 1997). Seeing images of their carotid arteries and whether or
not plaques are present may well help them to understand their risk of CHD and TIA
in a more concrete way and could as a result motivate behaviour change. A recent trial
which investigated the impact of electron beam tomography (EBT), which allows
patients to see images of their arteries, on risk of CHD did not find it to be effective in
reducing risk of CHD (O’Malley, Feuerstein, & Taylor, 2003). However, this study
was performed on healthy volunteers who typically had a low risk of CHD. In
addition, the study did not investigate whether EBT changed how patients thought
about their risk of disease which is a necessary precursor to behaviour change.
However, another study which investigated the effectiveness of ultrasound images in
motivating smoking cessation found more promising results (Bovet, Perret, Cornuz,
Quilindo, & Paccaud, 2002). In this study, smokers from the general population who
had atherosclerotic plaques and who received an ultrasound image of their carotid
arteries were much more likely to stop smoking than smokers who did not undergo
ultrasonography (22% quit rate versus 6% quit rate). Again this study did not
investigate the way in which receiving an ultrasound image changed the way that
participants thought about their risk. In addition, quit rates were low for (5%) in the
small group of smokers who were informed that they did not have any plaques and it
is important to find out if these people perceive themselves to have a lower risk of
developing CHD and TIA in the future. Therefore, we believe that a necessary first
step to investigating the potential of using imaging techniques and other means of
communicating personal risk information to patients is to investigate how they think
about this information. To this end we propose conducting a qualitative interview
study in order to best capture how patients respond to such images. The findings of
the present interview study will be used to generate hypotheses to be tested in future
empirical studies which aim to maximise the potential of personalised risk
information as a motivational tool. 5 6. Aims
1. To investigate hypertensive patients’ understanding and perceptions of viewing
ultrasound images of their carotid arteries.
2. To investigate hypertensive patients’ understanding and perceptions of discussing
these images with their clinician
3. To investigate hypertensive patients’ perceptions of the need to engage in riskreducing behaviours as a consequence of viewing this images and discussing the
findings with their clinician.
7. Design
This is a cross-sectional descriptive study in which patients are interviewed
approximately one-week after the consultation with their clinician. Anonymous
interview transcripts are analysed using interpretative phenomenological analysis (IPA).
8. Participants and sample size
Participants are patients with hypertension who attend an outpatients clinic at Goy’s
Hospital and who are referred for ultrasonography of their carotid arteries. Patients
who are referred for this investigation have a diagnosis of hypertension and at least
one other risk factor for CHD or stroke, typically raised cholesterol, diabetes, or being
a smoker. Between 10 and 15 patients where plaques are present and 10 and 15
patients where no plaques are present will be interviewed. Therefore the total sample
size is at least 20 patients and at most 30 patients. For descriptive interview studies,
approximately 10 participants who have experienced a similar event (such as being
informed that they have plaques in their carotid arteries) are usually sufficient to
generate a high quality analysis with thematic saturation. However, up to 15 in each
category (plaques present and plaques absent) will be interviewed should the patients
constitute a particularly heterogeneous group where thematic saturation has not
occurred after 10 interviews. Thematic saturation occurs when no new dominant
themes emerge in consecutive interviews. 6 9. Inclusion and exclusion criteria
Inclusion criteria
1. Patients with a diagnosis of hypertension attending the hypertension outpatient
clinic at Guy’s Hospital who are referred for ultrasonography of their carotid
arteries.
2. Aged 18 years or over.
3. Sufficient spoken and written English for the demands of the study.
Exclusion criteria
1. Recent Myocardial Infarction or TIA (less than six months).
2. Exclusion at the discretion of the clinician when clinical judgement suggests that
being interviewed will constitute a burden for the patient (for example where the
patient is depressed).
10. Informed consent
Patients will be given study information sheets and consent forms when referred for
the ultrasound scan or at the subsequent consultation with their clinician. Information
sheets and consent forms will either be sent by post or given face-to-face by the
clinician or the investigators.. Patients will be given at least 24 hours to decide if they
wish to consent to the interview study. Patients have the opportunity to discuss the
study with any member of the study team prior to deciding whether they wish to
participate.
11. The interview
For patients who consent to the study a date for interview will be made approximately
one week after the consultation with their clinician. Interviews will be arranged at a
time and place that is convenient for the patient and will take place either at the
hospital, at the participant’s home (see risk assessment), or over the telephone.
Interviews will be tape-recorded and transcribed. All identifying information will be
removed from interview transcripts. 7 The interview will be semi-structured and a schedule is attached in appendix II. The
semi-structured nature of the interview means that whilst the main topic areas will be
covered for each participant, the format of the interview will be sufficiently flexible to
allow the interview to follow-up specific experiences and perceptions that emerge in
each interview. The interview will cover participants experiences of being referred for
the ultrasound and the resultant discussion with their clinician, their understanding
and perceptions of what was shown on the ultrasound images, their understanding
about what the images mean for their risk of CHD and TIA, whether their
understanding of their risk has changed as a result of seeing these images and having
the consultation, and their perceived need to engage in risk-reducing behaviours (not
smoking, taking medication as prescribed, changing diet, taking exercise, etc) as a
result of seeing these images.
12. Data analysis
Interview transcripts will be analysed using Interpretative Phenomenological Analysis
(IPA) (Smith, 2003). IPA is an inductive form of qualitative data analysis in which
each transcript is analysed for emergent themes in a rigorous and structured manner.
Themes are then accumulated across the different transcripts in order to generate an
analysis that captures the perceptions of participants in general whilst still allowing
for individual and idiosyncratic experiences and understandings to be represented in
the analysis. IPA, which has become one of the dominant qualitative methodologies
for health psychology studies over the past decade, was chosen as the preferred
qualitative method for this study for a number of reasons. First, in areas where little is
known about the perceptions of participants it is recognised as a robust and rigorous
method of capturing and interpreting these perceptions. Second, and unlike some
other qualitative methods, it takes the participants accounts at face value and as
representing possibly stable thoughts, perceptions, and intended behaviours. As our
intention is to use this data to generate hypotheses to be tested in a later quantitative
study, it is one of the few qualitative methods that sit well with an a hypothesisgenerating and testing framework. 8 13. Ethical issues and risk assessment
This study will adhere to high ethical standards in the conduct and reporting of the
study. Patients will be fully informed of the purpose and procedure of the study and
will given time to decide whether they wish to participate together with the
opportunity to discuss the study with the investigators prior to making this decision.
They will have the opportunity to withdraw at any time. All identifying information
will be removed from interview transcripts. Audio-tapes will be destroyed after
transcription. Transcripts, and consent forms will be kept in a locked filing cabinet at
until one year after the start of the study. Transcripts will be kept secure until 10 years
after publication of the data.
In the extensive experience of the academic supervisors (Professor Weinman and Dr
Senior), patients who consent to be interviewed about their experiences of illness and
medical procedures do so because they have a desire to speak about these issues and
for altruistic motives (such as in the hope of improving medical care for patients in the
future). In the unlikely event that participants become upset when discussing their
experiences the chief investigator will discuss with the participant the options for
dealing with this distress: either speaking with their clinician at the hospital or with
their GP. The investigators will discuss any such events or concerns with Professor
Weinman, Dr Senior, and Dr Ferro.
Interviews will take place in the hospital, over the telephone, or in the home of the
participant depending on the wishes of the patient. Based on the judgement of the
clinician no patient will be invited to participate should there be any concerns about
potential risk to the interviewer. For interviews that take place in the home of the
patient the interviewer will inform Dr Senior of the time and place of the interview.
The interviewer will telephone Dr Senior prior to starting the interview and on leaving
the participants home. If Dr Senior has not heard from, or been able to contact, the
interviewer by a specified time she will inform the police. 9 14. References
Bovet, P., Perret, F., Cornuz, J., Quilindo, J., & Paccaud, F. (2002). Improved smoking
cessation in smokers given ultrasound photographs of their own atherosclerotic
plaques, Preventive Medicine, 34, 215-220.
Leventhal, H., Benyamini, Y., Brownlee, S., Diefenbach, M., Leventhal, E., PatrickMiller, L., & Robitaille, C., (1997). Illness representations: theoretical foundations.
Chapter in K.J. Petrie & J. Weinman (eds) Perceptions of health and illness: current
research and applications. London: Harwood.
McClure, J.B. (2002). Are biomarkers useful treatment aids for promoting health
behavior change? An empirical review, American Journal of Preventive Medicine, 22,
200-207.
O’Malley, P.G., Feuerstein, I.M., & Taylor, A.J. (2003). Impact of electron beam
tomography, with or without case management, on motivation, behavioural change,
and cardiovascular risk profile: A randomised controlled trial, JAMA, 289, 2215-2223.
Smith, J.A. (2003) (ed) Qualitative Psychology: A Practical Guide to Research
Methods. London: Sage 10 Appendix I
Ultrasonography of carotid arteries
High resolution ultrasound is used to assess the carotid arteries. Patients are
examined in the supine position. A 4-7MHz linear array transducer (HDI5000,
Philips Medical Systems, Reigate, Surrey, UK) is used to acquire longitudinal B-mode
ultrasound and colour flow images from the common, internal and external carotid
arteries. The images are then interrogated to identify the presence of atherosclerotic
disease. When lesions are detected, two hard copies are obtained; one is attached to
the patient records and the other given to the patient. The patient is shown images
from a normal carotid artery for comparison with their own images and an explanation
of the general significance of atherosclerotic plaques is given. 11 Appendix II
Interview schedule
1. Can you tell me about how you came to be a patient at the clinic?
2. What were your thoughts when your condition was first diagnosed?
3. What were your feelings at that time?
4. Have your thoughts and feelings changed since you first attended the clinic?
How?
5. Can you tell me a bit about what happened when you had the ultrasound scan of
your neck?
6. Did you have any expectations beforehand about what would happen? Were these expectations correct? How did what happened on the day differ from what you expected? What did you expect to see in the ultrasound scan?
7. What did you actually see? Can you describe the images to me Did they make sense to you? Could you understand what you were looking at?
8. What did the person doing the scan say to you? Would other information have been useful? Was this information understandable?
9. What were your thoughts about the scan between when you had it and when you
discussed the scan with your doctor? Did you think about having the scan at all or did you put it out of your
mind? Were you worried at all or were you fairly unconcerned? Did you think of questions or issues you would like to discuss with your
doctor about the scan?
10. What happened when you say your doctor and discussed the scan? Did it change what you could see in the scan or what you were thinking
about it? Did it change anything about how you think about your condition? Was the information you were given satisfactory or would you have liked
other information?
11. Overall has having the scan changed anything you think about your condition and
your risk of heart disease in the future? How do you feel about having such a scan? Has it changed anything that you do?
12 Finally, do you think it is a good idea to have ultrasound scans? 13

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