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Paul Little aCommunity
Clinical Sciences Division (Primary Medical Care Group), Faculty of
Medicine, Health and Biological Sciences, Southampton University,
Aldermoor Health Centre, Southampton SO16 5ST, b Nightingale
Surgery, Greatwell Drive, Romsey SO51 7QN, c St Clements Surgery,
Winchester SO23 8AD Correspondence
to: P Little psl3{at}soton.ac.uk
Primary care p 258
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Abstract |
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Objective:
To assess alternatives to measuring
ambulatory pressure, which best predicts response to treatment and
adverse outcome.
Setting:
Three general practices in England.
Design:
Validation study.
Participants:
Patients with newly diagnosed high or
borderline high blood pressure; patients receiving treatment for
hypertension but with poor control.
Main outcome measures:
Overall agreement with
ambulatory pressure; prediction of high ambulatory pressure (>135/85
mm Hg) and treatment thresholds.
Results:
Readings made by doctors were much higher than ambulatory systolic pressure (difference 18.9 mm Hg, 95% confidence interval 16.1 to 21.7), as were recent readings made in the
clinic outside research settings (19.9 mm Hg,17.6 to 22.1). This
applied equally to treated patients with poor control (doctor v ambulatory 21.4 mm Hg, 17.3 to 25.4). Doctors' and recent
clinic readings ranked systolic pressure poorly compared with
ambulatory pressure and other measurements (doctor r=0.46;
clinic 0.47; repeated readings by nurse 0.60; repeated self measurement
0.73; home readings 0.75) and were not specific at predicting high
blood pressure (doctor 26%; recent clinic 15%; nurse 72%; patient in
surgery 81%; home 60%), with poor likelihood ratios for a positive
test (doctor 1.2; clinic 1.1; nurse 2.1, patient in surgery 4.7; home 2.2). Nor were doctor or recent clinic measures specific in predicting treatment thresholds.
Conclusion:
The "white coat" effect is important
in diagnosing and assessing control of hypertension in primary care and
is not a research artefact. If ambulatory or home measurements are not available, repeated measurements by the nurse or patient should result
in considerably less unnecessary monitoring, initiation, or changing of
treatment. It is time to stop using high blood pressure readings
documented by general practitioners to make treatment decisions.
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What is already known on this topic
Preliminary evidence suggests that measurements by doctors are likely to be higher than those made by nurses, technicians, or patients No study has compared all the available measures in a typical primary care setting with ambulatory blood pressure in patients with newly diagnosed and established hypertension What this study adds
If ambulatory measurement is not possible, repeated measurement by a nurse or by the patient will result in much less unnecessary treatment or change in treatment for high blood pressure |
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Introduction |
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Hypertension is perhaps the most common reason for initiation of lifelong drug treatment and ongoing management by doctors. Ambulatory blood pressures may be a much better predictor of target organ damage and subsequent adverse events than measurements made in a clinic.1 As these results were found in research studies and mostly not in typical primary care settings, however, patients may have had a higher "alerting response" than in everyday settings with their family doctor or nurse. It is thus important to clarify whether the white coat effect applies equally outside a research study and in typical family practice settings.
Why is ambulatory monitoring not commonly used to make management decisions? The problem is not just extrapolating results from research or secondary care to routine settings but that clinic derived thresholds have been used in previous research to make treatment decisions. However, several lines of evidence show that patients with daytime ambulatory pressure lower than 135/85 mm Hg have a low risk of subsequent events.2 An ambulatory pressure of 135/85 mm Hg thus represents good control and approximately corresponds to a clinic pressure of 140/90 mm Hg,2 a generally accepted marker for control.3 Recent guidelines recommended ambulatory monitoring for both initial diagnosis and assessing control,4 although few studies have looked at the assessment role in primary care.5
What about other alternatives? Preliminary evidence, mostly from other settings, indicates that measurements by a nurse or technician, repeated measurements, or home measurements may be closer to ambulatory pressure.5-12 To our knowledge, no study in a typical primary care setting has compared these methods with ambulatory monitoring. Another alternative is self measurement by patients with equipment in the clinic, which to our knowledge has never been assessed.
We set out to assess the following in typical primary care settings.
(1) The white coat effect in the broad group in which decisions are
usually made on clinic readings (diagnosis and monitoring control). (2)
The extent of the white coat effect as a research artefact. (3) The
agreement between ambulatory monitoring of blood pressure and the
realistic alternatives (measurement by doctor or nurse, self
measurement in surgery, home). (4) The potential implications of using
alternative methods of blood pressure measurement in predicting
treatment thresholds.
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Methods |
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Eight doctors and three practice nurses from three varied practices, each serving 8000 patients, agreed to participate. Practice nurses were trained to use the 24 hour monitor and to follow the protocol of measurements.
Participants
Two hundred patients in whom management
changes were being considered on the basis of clinic readings
participated in the study. Participants were in two categories: newly
diagnosed or borderline hypertension (three clinic readings of
systolic blood pressure >140 mm Hg or diastolic pressure >90 mm
Hg),13 or established hypertension (three clinic readings
>160/100 mm Hg) being treated but with poor control (>140/90 mm
Hg).3 Most participants were referred opportunistically by
doctors; nine eligible patients declined to participate.
Sample size
Assuming that 50% of patients have high
systolic ambulatory pressure and that other methods can detect this
with a sensitivity and specificity of 70%, with a 95% confidence
interval of 60% to 80%, then we needed 180 participants.
Blood pressure measurements
See bmj.com for
equipment used and protocol for measurement of blood pressure by
nurses, patients, and doctors. We randomised the order of home and
ambulatory measurements. For the first 130 patients ambulatory or home
monitoring took place between the first and second visit to the nurse,
with the other measurement after the second visit.
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Results |
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Sample
Of the 200 participants, 107 (54%) were women, 63/194 (33%) were
over the age of 65, 96 had newly diagnosed high or borderline high
blood pressure (systolic pressure 161 (SD 16) mm Hg; diastolic pressure
95 (9) mm Hg), and 104 were treated but had poor control (systolic
pressure 163 (16) mm Hg; diastolic pressure 94 (9) mm Hg). Six patients
did not have ambulatory readings; 173 patients had a complete set of
all readings.
Estimating agreement: main results
Overall agreement for systolic pressure had a moderate rank
correlation (table 1). Readings made by the doctor were much higher
than systolic ambulatory pressure (difference=18.9 mm Hg, 95%
confidence interval 16.1 to 21.7), as were recent clinic readings not
made in a research study (19.9 mm Hg, 17.6 to 22.1). The white coat
effect applied equally for patients on established treatment with poor
control (readings by doctor v ambulatory pressure, difference=21.4 mm Hg, 17.3 to 25.4). For most methods the difference from ambulatory monitoring increased with blood pressure (a positive correlation on the Bland Altman plots, see table 1). Readings by the
doctor and in the clinic also ranked systolic ambulatory pressure
poorly compared with other methods (table 1). Most methods were
sensitive in predicting high systolic ambulatory pressure (all
sensitivity >75%), but readings by the doctor and recent clinic
readings were not specific, with poor likelihood ratios (table 2). Nor
were readings by the doctor or recent clinic readings specific in
predicting ambulatory systolic treatment thresholds, having poor
likelihood ratios (table 3). Measurement by the doctor and recent
clinic readings performed slightly better for diastolic pressures than
for systolic pressures, although other methods still performed better,
with higher likelihood ratios for a positive test.
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Attenuation of white coat effect with visits to nurse
The fall in blood pressure between the two visits to the nurse was
even greater for the last 70 patients, in whom no intervening
measurements occurred. For these 70 patients the difference between
ambulatory systolic pressure and measurements taken by the nurse was 11 mm Hg for the first visit and 2.8 mm Hg for the second visit.
Patient documentation at home compared with semiautomated
sphygmomanometer memory
Agreement existed for consecutive patients between the 14 readings
documented by patients and the machine memory for both systolic
pressure (n=21; r=0.97; mean difference 3.5 (SD 9.3) mm
Hg) and diastolic pressure (r=0.85; mean difference 1.4 (6.0) mm Hg). The differences between readings recorded by the patient
and the machine reflect the fact that "practice" readings or
readings taken at other times of day (for example, during work) were
also recorded by the machine.
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Discussion |
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Limitations of the study
Routine equipment
The agreement with ambulatory
pressure was similar when routine equipment was used and when well
validated equipment was used. Thus the main limitation of measurement
in routine clinic settings is not the type of sphygmomanometer used.
We used patients with newly diagnosed
hypertension and patients with poorly controlled hypertension, but this
reflected recent guidance.4 Furthermore, the subgroups
(newly diagnosed and established hypertension) had very similar blood pressures.
Arbitrary cut-off points to define potential management
decisions
Exact management thresholds will always be debated.
Nevertheless, agreement exists that poor control in clinic readings for
most patients is >140/90 mm Hg,3 and that for ambulatory
readings
135/85 mm Hg represents good control (although patients
with additional risk factors may need tighter
control).
2 4 14
There is also agreement that patients
with clinic pressures of >160/100 mm Hg need drug treatment to be
started,13 but debate continues about the threshold for
ambulatory pressure.
Order of measurements
Recent measurements in the
clinic (that is, historic measurements) were very similar to
measurements by the doctor (the last recorded in the study).
Furthermore, the drop between the two measurements by the nurse for the
first 130 patients could not be explained by the intervening home or 24 hour measurements, as a similar or greater effect was seen in the last
70 patients, for whom there were no intervening measurements. Thus the
differences between measurements are likely to be due not to effects of
order or time but to the different alerting responses for different measurements.
The white coat effect
artefact of setting, sample, or research
studies?
The estimates of the white coat effect in this study are similar
to those in previous work, mostly not from typical primary care
settings.6-12 Thus the white coat effect observed in the
major prognostic studies to date is not likely to be an artefact of
other settings or of research studies and applies equally to new
diagnosis and assessment of control.
Although debate continues about just how benign white coat hypertension
is,15 such studies have been criticised as some have not
measured the white coat effect in a standard way.16 Prospective studies indicate that patients with white coat hypertension are at considerably reduced risk compared with those with higher ambulatory pressures and that treatment modifies blood pressure and
outcomes only in patients with high ambulatory blood
pressure.
2 5 15
The overzealous initiation and
maintenance of treatment for white coat hypertension represents an
enormous opportunity cost for health professionals and for patients, in
addition to the associated iatrogenesis
particularly unnecessary
anxiety17 and side effects.
18 19
Are the alternatives to measurements by a doctor better?
Evidence exists from prospective studies about the relation
between ambulatory blood pressure and outcome.1 Nevertheless, ambulatory monitoring equipment is expensive (the machine
used in this study cost £2000), and each practice would need several
machines to cope with the workload.
This study shows that repeated readings by a nurse in primary care provide a better assessment than readings by doctors, supporting research from other settings.8 Patients can accurately measure and record their blood pressure themselves at home, 8 12 20 with great potential advantages of lower equipment and staff costs compared with ambulatory pressure. Self measurement by patients in the clinic may provide similar levels of overall agreement with ambulatory pressure to home measurement. More visits to the clinic are needed than for home readings, and suitable rooms have to be made available. The estimates from this study are also less precise and need confirmation (only 52 of the 70 patients invited completed both measurements).
Conclusion
The "white coat" effect is important in diagnosing and
assessing control of hypertension in primary care and is not a research
artefact. If ambulatory or home measurements are not available,
repeated measurements by a nurse or the patient should result in
considerably less unnecessary monitoring, initiation, and changing of
treatment. It is time to stop using high blood pressure readings
documented by general practitioners to make decisions about treatment.
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Acknowledgments |
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We thank the doctors, staff, and patients at Aldermoor Health Centre, Nightingale Surgery, and St Clements Surgery. We also thank Eoin O'Brien for advice and helpful comments. DM is now employed at the Division of Public Health and Primary Care, Institute of Health Sciences, Oxford OX3 7LF.
Contributors: See bmj.com
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Footnotes |
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Funding: NHS Regional Research and Development Grant and the HOPE charity. PL is funded by the Medical Research Council.
Competing interests: None declared.
The full version of this paper
appears on bmj.com
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References |
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(Accepted 21 March 2002)
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