Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection (cough)

Level of evidencePatient population/characteristicsSelection/inclusion criteriaInterventionComparisonFollow-upOutcomeEffect size
ID: 425

Level of evidence: (1+)

Study type: open RCT

Authors: Little et al. (2005)
Patients aged 3 years or older with uncomplicated acute lower respiratory tract infection (≤ 21 days) who presented in primary care

A 2 × 3 factorial design:
Factor 1 = info leaflet, no leaflet
Factor 2 = AB strategies (immediate AB, delayed AB, no AB)

No. of participants (completed trial):
Total = 639
No leaflet/no AB = 100
No leaflet/delayed = 107
No leaflet/AB = 112
Leaflet/no AB = 100
Leaflet/delayed = 107
Leaflet/AB = 113

At baseline (based on N = 807):
Children = 17%
Adults = 66%
Older patients = 17%

Leaflet
Mean age = 39
Prior duration of cough (mean days) = 9.6
Mean temperature = 36.6

No leaflet
Mean age = 38
Prior duration of cough (mean days) = 9.5
Mean temperature = 36.7

No AB
Mean age = 39
Prior duration of cough (mean days) = 9.9
Mean temperature = 36.7

Delayed AB
Mean age = 38
Prior duration of cough (mean days) = 9.4
Mean temperature = 36.6

Immediate AB
Mean age = 40
Prior duration of cough (mean days) = 9.4
Mean temperature = 36.6

*No significant differences at baseline comparisons
Inclusions:
Patients with (≤ 21 days) cough as the main symptom and with at least one symptom or sign localizing to the lower tract (sputum, chest pain, dyspnoea, wheeze)

Exclusions:
  • Patients with a history and physical examination suggestive of pneumonia based on British Thoracic Society guideline
  • Patients clinically diagnosed with asthma; other chronic or acute lung diseases including cystic fibrosis, cardiovascular disease, major current psychiatric diagnosis, mental subnormality, dementia
  • Patients with previous episodes of LRTIS (e.g. hospital admission for pneumonia)
Study period:
18/08/98–30/07/03

Settings:
37 physicians in primary settings in the region of southwest England
(Factor 2)
  1. Delayed prescription (Patients asked to fill the prescription if symptoms failed to improve after 14 days]
  2. Immediate AB prescription
(Factor 2)
No AB prescription (as control)
At 3 weeksDaily symptom diary:
Primary outcomes (1):
(No AB as control) – controlling effect of leaflet
1) Delayed AB vs. no AB
(Factor 1)
Information leaflet (info about natural history and also addressed patients’ major worries and provided advice about when to seek further help, (e.g. persistent fever, worsening shortness of breath)
(Factor 1)
No information leaflet (as control)
Duration of cough – day (until very little problem)Mean diff = 0.75
(95% CI: −0.37 to 1.88), p = 0.19
Duration of moderately bad cough – dayMean diff = 0.13
(95% CI: −1.70 to 2.00), p = 0.89
Severity of symptoms (point scale 0–6)Mean diff = 0.06
(95% CI: −0.15 to 0.27), p = 0.56
2) Immediate AB vs. no AB
Duration of cough – day (until very little problem)Mean diff = 0.11
(95% CI: −1.01 to 1.24), p = 0.19
Mode of delivery:
  • All patients, irrespective of whether they had the leaflet, were given brief verbal information about the likely range of natural history of the illness and supporting the proposed prescribing strategy
  • For delayed prescription, parents were asked to come back to collect the prescription for AB (prescription left at the reception)
Mode of delivery:
  • All patients, irrespective of whether they had the leaflet, were given brief verbal information about the likely range of natural history of the illness and supporting the proposed prescribing strategy
Duration of moderately bad cough – dayMean diff = 0.52
(95% CI: −1.30 to 2.40), p = 0.19
Severity of symptoms (point scale 0–6)Mean diff = −0.10
(95% CI: −0.31 to 0.11), p = 0.11
Adjusted severity of symptoms – point scale 0–6 on 6 symptoms (adjusted baseline variables):
1) Delayed AB vs. no ABAdj mean diff = −0.02, p = 0.86
2) Immediate AB vs. no ABAdj mean diff = −0.07, p = 0.49
3) Leaflet vs. no leafletAdj mean diff = −0.05, p = 0.58
Analgesics:
Advice to take an analgesic
Analgesics: Advice to take an analgesicAdverse events (Diarrhoea):
1) Delayed AB vs. no ABOR = 1.17 (95% CI: 0.67–2.03), p = 0.58
2) Immediate AB vs. no ABOR = 1.22 (95% CI: 0.70–2.12), p = 0.48
Primary outcomes (2):
(No leaflet as control) – controlling effect of AB strategies
Duration of cough (until very little problem)Mean diff = 0.26
(95% CI: −0.66 to 1.18), p = 0.58
Duration of moderately bad coughMean diff = 0.20
(95% CI: −0.16 to 2.00), p = 0.83
Severity of symptomsMean diff = −0.03
(95% CI: −0.20 to 0.15), p = 0.77
Questionnaire outcomes:
1) AB strategies
Used ABNo AB (16%), delayed AB (20%), immediate AB (96%), p < 0.01
Believed in ABNo AB (47%), Delayed AB (40%), Immediate AB (75%), P < 0.01
Very satisfiedNo AB (72%), delayed AB (77%), immediate AB (86%), p = 0.05
2) Info leaflet:
Used ABNo leaflet (57%), leaflet provided (55%)
p = 0.58
Believed in ABNo leaflet (56%), leaflet provided (54%)
p = 0.73
Very satisfiedNo leaflet (76%), leaflet provided (78%)
p = 0.24
Re-attendance within 1 month
(No AB as control)
1) Delayed ABIncidence rate ratio estimate = 0.65 (95% CI: 0.40–1.04), p = 0.08
2) Immediate ABIncidence rate ratio estimate = 0.55 (95% CI: 0.33–0.91), p = 0.02
(No leaflet as control)
Leaflet providedIncidence rate ratio estimate = 1.63 (95% CI: 1.07–2.49), p = 0.02
Chief findings/comments:
  • A well conducted open RCT with 2 × 3 factorial designs with large sample size.
  • The study found that no AB prescription or a delay offer of AB only associated with little nonsignificant difference in symptom resolution of lower respiratory tract infection (cough).
  • No AB prescription and a delay offer of AB also likely to reduce AB use and beliefs in the effectiveness of antibiotics.
  • The study also suggested that one advantage of delayed or immediate AB is fewer re-attendances with cough in the month after the physician visit.
  • However, there was lack of effect of an information leaflet. The lack of effect could be diluted by the verbal information provided.
Methodology/potential confounder/bias:
  • Individual recruitment rates not reported.
Generalisability:
  • UK-based GP practices, highly generalisable to UK population.

From: 6.4 Appendix 4, Inclusion and exclusion criteria and evidence tables

Cover of Respiratory Tract Infections - Antibiotic Prescribing
Respiratory Tract Infections - Antibiotic Prescribing: Prescribing of Antibiotics for Self-Limiting Respiratory Tract Infections in Adults and Children in Primary Care.
NICE Clinical Guidelines, No. 69.
Centre for Clinical Practice at NICE (UK).
Copyright © 2008, National Institute for Health and Clinical Excellence.

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