BMJ 2002;324:91 ( 12 January )



Primary care

     Reducing antibiotic use for acute bronchitis in primary care: blinded,
randomised controlled trial of patient information leaflet
<http://bmj.com/cgi/content/full/324/7329/#art>


Reducing antibiotic use for acute bronchitis in primary care: blinded,
randomised controlled trial of patient information leaflet
<http://bmj.com/cgi/content/full/324/7329/#Top>

John Macfarlane, consultant physician a, William Holmes, principal in
general practice b, Philip Gard, principal in general practice c, David
Thornhill, principal in general practice d, Rosamund Macfarlane, research
administrator e, Richard Hubbard, senior lecturer in clinical epidemiology
f.
a Respiratory Medicine, Nottingham City Hospital NG5 1PB, b Sherrington Park
Medical Practice, Nottingham NG5 2EJ, c Arnold Health Centre, Arnold,
Nottingham NG5 7BP, d Stenhouse Medical Centre, Arnold, Nottingham NG5 7BP,
e Respiratory Infection Research Group, Nottingham City Hospital, f
University of Nottingham, Clinical Sciences Building, Nottingham City
Hospital
Correspondence to: J Macfarlane [log in to unmask]
<mailto:[log in to unmask]>



  Abstract
Objective: To assess whether sharing the uncertainty of the value of
antibiotics for acute bronchitis in the form of written and verbal advice
affects the likelihood of patients taking antibiotics.
Design: Nested, single blind, randomised controlled trial.
Setting: Three suburban general practices in Nottingham
Participants: 259 previously well adults presenting with acute bronchitis.
Intervention: In group A, 212 patients were judged by their general
practitioner not to need antibiotics that day but were given a prescription
to use if they got worse and standard verbal reassurance. Half of them (106)
were also given an information leaflet. All patients in group B (47) were
judged to need antibiotics and were given a prescription and encouraged to
use it.
Main outcome measures: Antibiotic use in the next two weeks. Reconsultation
for the same symptoms in the next month.
Results: In group A fewer patients who received the information leaflet took
antibiotics compared with those who did not receive the leaflet (49 v 63,
risk ratio 0.76, 95% confidence interval 0.59 to 0.97, P=0.04). Numbers
reconsulting were similar (11 v 14). In group B, 44 patients took the
antibiotics.
Conclusion: Most previously well adults with acute bronchitis were judged
not to need antibiotics. Reassuring these patients and sharing the
uncertainty about prescribing in a information leaflet supported by verbal
advice is a safe strategy and reduces antibiotic use.




What is already known on this topic
Most adults with acute bronchitis who consult their general practitioner
will receive antibiotics
For most patients antibiotics do not modify the natural course of the
symptoms
The widespread belief among patients that infection is the problem and
antibiotics the solution has considerable influence on prescribing by
general practitioners, even when they judge that antibiotics are not
definitely indicated
What this study adds
General practitioners judged that about four in five adults with acute
bronchitis did not definitely need antibiotics on the day they consulted
Antibiotic use was reduced by a quarter in such patients, who received
verbal and written information and reassurance in addition to a prescription
for antibiotics
Sharing with the patient the uncertainty about the decision to prescribe
seems safe and effective





  Introduction
Acute bronchitis is a common condition that results in nearly 2 million
consultations in England and Wales each year. 1
<http://bmj.com/cgi/content/full/324/7329/#B1>  2
<http://bmj.com/cgi/content/full/324/7329/#B2>  General practitioners
prescribe antibiotics in three quarters of such consultations, even though
there is little evidence to justify it. 2
<http://bmj.com/cgi/content/full/324/7329/#B2>  3
<http://bmj.com/cgi/content/full/324/7329/#B3>  The widespread belief among
patients with acute bronchitis that infection is the problem and antibiotics
the solution has considerable influence on prescribing of antibiotics by
general practitioners, even when their clinical judgment is that antibiotics
are not definitely indicated. 3-5
<http://bmj.com/cgi/content/full/324/7329/#B3>  This is a factor in the
overuse of antibiotics and the increasing prevalence of drug resistance,
adverse effects, and cost. 6 <http://bmj.com/cgi/content/full/324/7329/#B6>
As a major reason for the use of antibiotics in acute bronchitis seems to be
the expectations of patients, we conducted a randomised, controlled,
clinical trail to determine the impact of a patient information leaflet on
the use of antibiotics in patients with this condition.




  Methods
Recruitment and initial assessment of participants
Participants for the trial were recruited from three general practices in
Nottingham familiar with research in this topic. 3
<http://bmj.com/cgi/content/full/324/7329/#B3>  4
<http://bmj.com/cgi/content/full/324/7329/#B4>  7-9
<http://bmj.com/cgi/content/full/324/7329/#B7>  Between September 1999 and
August 2000 (excluding a month over Christmas and the millennium period), we
recruited consecutive adults presenting with "acute bronchitis," defined as
a "new, acute lower respiratory tract illness in a previously well adult,"
using previously reported definitions (box 1
<http://bmj.com/cgi/content/full/324/7329/#FB1> ). 4
<http://bmj.com/cgi/content/full/324/7329/#B4>  8-11
<http://bmj.com/cgi/content/full/324/7329/#B8>


Box 1 : Definitions for recruitment
*       Patients aged >= 16 years who were previously well and not under
supervision or management for an underlying disease (for example, no
pre-existing asthma, chronic obstructive pulmonary disease, heart disease,
and diabetes)
*       Lower respiratory tract illness required all of:
        Acute illness present for 21 days or less
        Cough as the main symptom
        At least one other lower respiratory tract symptom (sputum production,
dyspnoea, wheeze, chest discomfort or pain)
        No alternative explanation (for example, not sinusitis, pharyngitis, a new
presentation of asthma)


The study was approved by the Nottingham City Hospital ethics committee, and
all participants provided written consent.
Each general practitioner managed the patients according to their usual
clinical practice and based on their clinical judgment divided them into two
groups: group A, in which antibiotics were not definitely indicated that
day, and group B, in which antibiotics were definitely indicated that day.
This decision was made without additional guidance or investigations.
Antibiotic prescriptions and randomisation
All patients were given a prescription for an antibiotic, the choice of
which was left to the general practitioner, and a sealed envelope containing
a two week diary card with instructions, pen, and a stamped, addressed
return envelope. Patients in group B were advised to take the antibiotics.


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Fig 1.   Information leaflet given to patients

For all patients in group A the general practitioner provided verbal
information based on a prompt card (box 2
<http://bmj.com/cgi/content/full/324/7329/#FB2> ). These patients were then
randomised by using permuted blocks of four to receive or not receive a
patient information leaflet about the natural course of lower respiratory
tract symptoms and the advantages and disadvantages of antibiotic use (fig 1
<http://bmj.com/cgi/content/full/324/7329/#F1> ). The patient information
leaflet was in the sealed envelope, blinded from the general practitioner by
means of a blank leaflet, together with the diary card and return envelope.
Patients were asked to open and read the contents of the envelope after the
consultation.


Box 2 : Prompt card for verbal information given to patient by general
practitioners
"I have examined you and I am happy there is no sign of serious disease
which definitely needs antibiotics today. Most chesty illnesses get better
on their own, although the cough may take a long time to go completely.
Antibiotics don't seem to make much difference to how quickly most people
recover. However, if you feel you are getting worse after a while,
considering taking antibiotics then would be reasonable.
So, here is a prescription for an antibiotic for you to keep at home. You
are quite likely not to need it, but use your judgment whether to get them
in due course."


End points and follow up
The primary end point was whether the patient took the antibiotics they had
been prescribed. This information was obtained from the symptom diary, which
included a space to record daily antibiotic use, and by telephone contact.
Patients were contacted by telephone at around one week and two weeks after
the consultation by research assistants blinded to the grouping of the
patients. Answers to structured questions regarding antibiotic use were
recorded.
The secondary outcome was whether patients initiated a further consultation
for the same symptoms within the next month. Patients were not asked to
return routinely by the general practitioner. We have previously reported
that reconsultation is an easily measured and consistent end point for acute
bronchitis and relates to persistent cough and patient dissatisfaction with
their progress. 8 <http://bmj.com/cgi/content/full/324/7329/#B8>  9
<http://bmj.com/cgi/content/full/324/7329/#B9>  11
<http://bmj.com/cgi/content/full/324/7329/#B11>  12
<http://bmj.com/cgi/content/full/324/7329/#B12>
We carried out a pilot study of 33 consecutive patients with acute
bronchitis to develop consistency of data collection by the general
practitioners and telephone follow up by the research assistants.
Statistical analysis
Our primary hypothesis was that the proportion of patients in group A who
would take antibiotics during the two week follow up period would be lower
in those who received the leaflet than in those in the control group. We
calculated the risk ratio and 95% confidence interval using EpiInfo and used
a chi 2 test with Yates's correction for the hypothesis test. Using these
data we calculated the number need to treat as the reciprocal of the
absolute difference in antibiotic uptake between the two groups.
To calculate sample size we set a minimum difference of 20% in primary
outcome between the two intervention arms in group A and a discriminatory
power of 80%. The required number in group A was 206.
To look for possible confounding by age, sex, surgery, smoking status,
description of cough, duration of cough, and the presence of chest signs we
used a series of bivariate logistic regression models within Stata (version
5). We also examined whether the impact of the leaflet on antibiotic uptake
was modified by any of these variables by fitting a series of multiplicative
interaction terms and comparing the nested models using the likelihood ratio
test.
We constructed a Kaplan-Meier plot from the days between consultation and
the day antibiotics were started and calculated the rate ratio using a Cox
regression model within Stata. We tested the proportional hazard assumption
of this model using the diagnostic section within Stata (ph1test).





  Results
Participants
During the study, the general practitioners saw 280 patients with acute
bronchitis, 259 of whom agreed to participate in the study (table, fig 2
<http://bmj.com/cgi/content/full/324/7329/#F2> ). Of the 212 patients in
group A, 106 received the patient information leaflet and 106 did not. Among
patients who were given the leaflet, two were lost to follow up, and 49
(47%) took their antibiotics. For patients in the control group five were
lost to follow up, and 63 (62%) took their antibiotics (risk ratio 0.76, 95%
confidence interval 0.59 to 0.97, P=0.04; number needed to treat 6.7).



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Details of patients with acute bronchitis for whom general practitioners
thought that antibiotics were not definitely indicated on day of
consultation, according to whether patient received written information.
Figures are numbers of patients unless stated otherwise with denominators
shown when data were incomplete


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Fig 2.   Flow of patients through whole study and nested trial of
information leaflet

Within the logistic regression model we found no evidence of confounding by
age, sex, smoking status, whether patients paid for their prescriptions,
description of cough or sputum, duration of cough, presence of chest signs,
or general practice. In addition there was no evidence of significant effect
modification by any of these variables.
Figure 3 <http://bmj.com/cgi/content/full/324/7329/#F3>  shows the
Kaplan-Meier plot. The rate ratio for the intervention group compared with
the control group was 0.66 (0.46 to 0.96). The reconsultation rates were
similar for all patients in group A (table). For the 47 patients in group B
(20% of all patients), all of whom were told by their doctor that
antibiotics were definitely indicated, 44 (94%) took their antibiotics.


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Fig 3.   Kaplan-Meier plot of number of days between consultation and day of
taking antibiotics for those who did and did not receive information leaflet






  Discussion
Use of antibiotics by patients with acute bronchitis can be reduced by
providing patients with a simple information leaflet about the use of
antibiotics and the natural course of acute bronchitis and giving
reassurance after a consultation and examination that their condition is not
serious. The use of the patient information leaflet reduced the use of
antibiotics by nearly a quarter. If these results are extrapolated to
national figures, about 750 000 fewer courses of antibiotics could be
prescribed each year.
This may underestimate the true efficacy of the leaflet as all patients were
also reassured verbally by their general practitioner that antibiotics were
not definitely indicated at the time of the consultation. The effect of the
leaflet was seen not only at the time of the consultation but continued over
the following two weeks of observation. By contrast, when the general
practitioner recommended that antibiotics were definitely indicated, nearly
all patients said they did take them, emphasising the strong influence of
doctors' advice on patient compliance.
Prescribing and management strategies for acute bronchitis
Most episodes of acute bronchitis resolve on their own, and how to identify
those few patients who may benefit from antibiotics is not clear. 2
<http://bmj.com/cgi/content/full/324/7329/#B2>  13
<http://bmj.com/cgi/content/full/324/7329/#B13>  Prescribing antibiotics for
patients with such self limiting conditions can be counterproductive as it
reinforces the belief that antibiotics are beneficial and encourages future
consultations. 10 <http://bmj.com/cgi/content/full/324/7329/#B10>  13
<http://bmj.com/cgi/content/full/324/7329/#B13>
Providing patients with information and using a delayed prescription have
been advanced by the National Prescribing Centre of the NHS 13
<http://bmj.com/cgi/content/full/324/7329/#B13>  and the Standing Medical
Advisory Committee of the Departments of Health 14
<http://bmj.com/cgi/content/full/324/7329/#B14>  as strategies for reducing
antibiotic use in the community. Open studies of managing uncomplicated
respiratory infection in adults 15
<http://bmj.com/cgi/content/full/324/7329/#B15>  and sore throat and otitis
media in children in primary care 16-18
<http://bmj.com/cgi/content/full/324/7329/#B16>  have shown that such
strategies result in fewer people taking antibiotics. Our study supports
this approach for adults with acute bronchitis. There are nearly three
million consultations for acute bronchitis annually in England and Wales 1
<http://bmj.com/cgi/content/full/324/7329/#B1>  and an incidence of up to 70
per 1000 for a practice population of previously well adults. 8
<http://bmj.com/cgi/content/full/324/7329/#B8>  Reducing antibiotic use by a
quarter would substantially influence antibiotic use in the community, as
currently up to three quarters of UK adults who consult with acute
bronchitis receive antibiotics, and the figures are even higher in some
other European countries. 10-13
<http://bmj.com/cgi/content/full/324/7329/#B10>
Further studies could assess whether reassurance and sharing information and
prescribing decisions would lead to longer term benefits for individuals and
the community in terms of less dependence on antibiotics. 10
<http://bmj.com/cgi/content/full/324/7329/#B10>  13
<http://bmj.com/cgi/content/full/324/7329/#B13>  19
<http://bmj.com/cgi/content/full/324/7329/#B19>  Little et al showed that
prescribing antibiotics for sore throat and otitis media increased the
likelihood of consultations during future episodes. 18
<http://bmj.com/cgi/content/full/324/7329/#B18>  20
<http://bmj.com/cgi/content/full/324/7329/#B20>  For acute bronchitis, we
have shown that pressures at home and work and concerns about the
seriousness of the problem are also associated with the likelihood of
seeking medical attention. 21
<http://bmj.com/cgi/content/full/324/7329/#B21>
The strategy of verbal and written information seems practical and safe. The
leaflet was cheap and simple to produce, and the study was conducted during
normal consultations by general practitioners. Most patients seemed happy
with the approach. Few declined to take part in the study or expressed
concern about sharing the prescribing decision with their doctor. Rates of
reconsultation were no higher in the leaflet group, and no patients required
referral to hospital for respiratory illness during follow up. A similar
study on management of acute cough also showed that an information leaflet
led to fewer future consultations for minor coughs and no delays in
consultations for more serious respiratory symptoms. 19
<http://bmj.com/cgi/content/full/324/7329/#B19>  We developed our leaflet
from one we used successfully to reduce reconsultation rates in a previous
study of acute bronchitis (that is, acute lower respiratory tract illness in
a previously well adult). 9 <http://bmj.com/cgi/content/full/324/7329/#B9>
Our results support the development of a more robust study in which no
prescription would be offered.
Study weaknesses
We did not measure antibiotic use directly, a problem shared with other
studies. 15-18 <http://bmj.com/cgi/content/full/324/7329/#B15>  We have
previously reported on a simple technique using a bioassay on urine to check
whether patients in the community are using their prescriptions for
antibiotics. 22 <http://bmj.com/cgi/content/full/324/7329/#B22>  However, in
the current study we could not devise a method of collecting urine from the
patients in an informed manner without compromising our objectives. We
considered leaving the filled out prescription with the practice
receptionist and recording the number collected, a method used in previous
studies. 15 <http://bmj.com/cgi/content/full/324/7329/#B15>  16
<http://bmj.com/cgi/content/full/324/7329/#B16>  18
<http://bmj.com/cgi/content/full/324/7329/#B18>  However, this does not
record antibiotic consumption and is more inconvenient for both the patient
and the practice than our approach. Arguably, it is also less representative
of typical practice and can lead to patients with acute cough feeling
dissatisfied and less empowered. 15
<http://bmj.com/cgi/content/full/324/7329/#B15>
Our practices were used to doing research in this topic, which may make the
doctors and patients unrepresentative. This may have encouraged the general
practitioners to include more patients in the group thought not to need
antibiotics and hence provide a sterner test of the information strategy we
used.
How this study helps general practitioners
Of course some patients with an acute lower respiratory tract illness do
benefit from antibiotics. 23 <http://bmj.com/cgi/content/full/324/7329/#B23>
In our study nearly one in five patients were thought to need antibiotics, a
figure consistent with that found in previous studies. 10
<http://bmj.com/cgi/content/full/324/7329/#B10>  Further research would
identify those patients most likely to benefit from antibiotics. 2
<http://bmj.com/cgi/content/full/324/7329/#B2>  We have shown that
investigating patients for infection either at first presentation or when
they reconsult is not a useful strategy for better targeting of antibiotic
treatment. 7 <http://bmj.com/cgi/content/full/324/7329/#B7>  8
<http://bmj.com/cgi/content/full/324/7329/#B8>  For the many patients
(around 80%) for whom the general practitioner thinks that antibiotics are
not definitely indicated, we have shown that sharing uncertainty about
prescribing openly and honestly with the patient is safe and effective and
also reduces antibiotic use.




  Acknowledgments
We thank the general practitioners who participated in the study: Gina
Bajek, Stephen Bolsher, Anne Cockburn, Fiona Coutts, Mike Elliott, Andrew
Flewitt, Phil Gard, Brian Hammersley, Bill Holmes, Richard Howard, Christine
Leiper, Elaine Maddock, Fiona McCracken, Suresh Patel, Peter Pavier, Kathy
Scahill, David Thornhill, and P Wilson. We also thank the practice staff, in
particular Dawn Hill, Jill Moon, and Karen Glover who coordinated the study
in each practice, Susan Allen and Tracy Broadhurst for performing the
patient telephone follow up, and Jennie Etches for help with data entry.
Contributors: JM had the original idea for the study and all authors were
involved in the design and planning. RM coordinated the study logistics
throughout and WH, PG, and DT liaised with their colleagues and staff in the
three practices and monitored reconsultations. RM and RH performed the data
analysis. The paper was written by JM, who acts as guarantor (with RH as
guarantor for data analysis), with input from all authors.

  Footnotes
Funding: British Lung Foundation.
Competing interests: JM has received consultancy fees from Pfizer, Abbott,
Hoechst Marion Roussel, Trinity, Glaxo Wellcome; research funding from
Hoechst Marion Roussel, Rhone Poulenc Rorer, and Bayer; lecture fees from
AstraZeneca, Hoechst Marion Roussel, and Pfizer; and support for attending
conferences from Astra, Pfizer, Allen and Hanbury, and 3M. WH has received
consultancy fees from Glaxo Wellcome, Schering Plough, Boehringer Ingleheim,
Hoechst Marion Roussel, Astra, 3M, Zeneca, and Rhone Poulenc Rorer; research
funding from 3M and Rhone Poulenc Rorer; and support for attending
conferences or courses from Glaxo Wellcome, Schering Plough, Zeneca, and 3M.
RH received support from Bayer for attending two scientific meetings and to
support a research project.



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<http://bmj.com/cgi/external_ref?access_num=7885119&link_type=MED> .
(Accepted 20 September 2001)
  _____


Commentary: More self reliance in patients and fewer antibiotics: still room
for improvement  <http://bmj.com/cgi/content/full/324/7329/#Top>

Chris van Weel, professor.
Department of General Practice, University Medical Centre St Radboud,
Nijmegen, Netherlands

The study of Macfarlane et al examines the old problem of overprescribing of
antibiotics, but it approaches the problem in a highly original way. To what
extent can their findings be applied to routine care in general practice.
Firstly the reduction of antibiotic use. The empirical findings of acute
bronchitis in general practice can in all probability be generalised: many
prescriptions for antibiotics are given for episodes of illness that usually
are self limiting. Use of antibiotics under these circumstances is often
spurious and does not contribute to patients' wellbeing. Undue use of
antibiotics may at the same time contribute to the growing concerns about
resistance. These are sound professional arguments for the restriction of
prescribing.
But patients influence prescribing, and there is a strong perception among
practitioners---whether true or not---that patients in general value a
prescription for antibiotics. Macfarlane et al focused their intervention on
the interaction between professional opinion and patients' values. The
intervention of inviting patients not to use the prescribed antibiotics is
something most general practitioners do most days. They offer reassurance
and encouragement to the patient to await the natural, benign course of an
infection, without removing the possibility of antibiotic treatment. The
advantages are obvious. The procedure takes away the power struggle between
the patient and the general practitioner, who is in charge of prescribing,
and focuses the patient's decision on the content of the advice. This paper
shows that general practitioners can distinguish between those in need of
antibiotic treatment and those who can do without it and can substantially
reduce the reliance on antibiotics. But it is important to note that about
half of the patients still used the antibiotics that their general
practitioner thought they could do without. So there is substantial room for
improvement.
One problem with the authors' intervention is the message it gives to the
patients, and here the approach used may not be as easy to transfer to
routine care. The explicit message ("antibiotics are not required") was
accompanied by the handing out of a prescription that implied a totally
different message. This inconsistency may trigger doubt and lack of
confidence in the proposed self reliance, particularly in patients who value
medical as opposed to self treatment and prefer external powers to deal with
their problems. This group is particularly at risk of medicalisation,
including repeated prescriptions of for unnecessary antibiotics for self
limiting infections.
The medical setting is not a harmless placebo and can have positive and
negative effects. Macfarlane et al should be complimented on their way of
bringing this setting into the test of effectiveness. An obvious alternative
way to test their current intervention would be to examine the patient and
give advice to come back in a couple of days if the predicted wearing off of
their symptoms did not occur. Continuity of care is not a panacea, but I
would not be surprised if it were able to reduce such unnecessary use of
antibiotics by more than half.






Edward E. Rylander, M.D.
Diplomat American Board of Family Practice.
Diplomat American Board of Palliative Medicine.