Family Practice Vol. 16, No. 3, 269-277
© Oxford University Press 1999
Evidence-based guidelines for the management of genital chlamydial infection in general practice
Department of General Practice and Primary Health Care, University of Leicester, Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW,
a Department of Genito-Urinary Medicine, The Leicester Royal Infirmary NHS Trust, Leicester LE1 5WW,
b The Surgery, Whitwick Road, Coalville LE67 3FA,
c Uppingham Road Health Centre, 131 Uppingham Road, Leicester LE5 4BP,
d The Central Surgery, Brooksby Drive, Oadby LE2 5AA,
e Bridge Street Medical Practice, 20 Bridge Street, Loughborough LE11 1NQ,
f General Practice Postgraduate Education Department, University of Leicester, Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK.
Dr TN Stokes, Department of General Practice and Primary Health Care, University of Leicester, Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK.
Stokes T, Schober P, Baker J, Bloor A, Kuncewicz I, Ogilvy J, French A, Henry C and Mears J. Evidence-based guidelines for the management of genital chlamydial infection in general practice. Family Practice 1999; 16: 269–277.
Received 11 August 1998; Accepted 28 January 1999.
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Abstract |
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Background. Valid clinical guidelines can be effective in improving patient care. Genital Chlamydia trachomatis infection is the commonest curable sexually transmitted disease (STD) in England and Wales and is an important cause of pelvic inflammatory disease (PID), tubal infertility and ectopic pregnancy. No published guidelines exist on managing genital chlamydial infection in British general practice.
Objective. We aimed to develop valid guidelines for the management of genital chlamydial infection for use in British general practice.
Methods. A district-wide postal questionnaire survey was used to document current clinical practice. A critical review of the evidence concerning the management of genital chlamydial infection as it relates to British general practice was performed. The information gained from the critical review and survey was used to develop evidence-based guidelines within a multidisciplinary guideline recommendation group.
Results. The guidelines covered the diagnosis, investigation, drug treatment and referral of adult male and female patients with genital chlamydial infection in general practice.
Conclusion. Valid guidelines for the management of genital chlamydial infection have been developed for use in British general practice. Appropriate dissemination and implementation of the guidelines should lead to earlier detection and treatment of men and women with chlamydial infection and thereby reduce the incidence of PID, tubal infertility and ectopic pregnancy in women.
Keywords. Chlamydia trachomatis, general practice, guidelines.
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Introduction |
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Genital Chlamydia trachomatis infection is the commonest curable sexually transmitted disease (STD) in England and Wales.1 The Chief Medical Officer in England has recently published an expert advisory group report on chlamydia which recommends action to reduce the prevalence and morbidity of this infection.2
The best current estimate of the prevalence of genital chlamydia in women attending UK general practice is 3–4% (estimates range from 2 to 12%).3 Chlamydial infection is asymptomatic in up to 70% of women and symptoms of infection, when they occur, are mild and non-specific.4–6 Untreated infection may spread to the upper genital tract and be transmitted to other sexual partners. The three important complications that may result are pelvic inflammatory disease (PID), tubal infertility and ectopic pregnancy. These complications are costly to treat and a cause of significant morbidity. The prevalence of genital chlamydia in men attending general practice is not known.3 Chlamydial infection is asymptomatic in up to 25% of men.4,5 The commonest clinical presentions are non-gonococcal urethritis (NGU) and epididymitis. Most of the morbidity and economic costs of male chlamydial infection result from infection of female sexual partners who go on to develop PID.
GPs and other members of the primary health care team have a role in the prevention of genital chlamydial infection. There is evidence that prompt detection and treatment of infection, together with contact tracing of sexual partners, can reduce the subsequent risk of PID, tubal infertility and ectopic pregnancy.1,3,5 Surveys of the management of genital chlamydia by British GPs have, however, shown that there is scope for improvement of the detection, treatment and follow-up of patients with chlamydial infection.6,7 One way of improving the management of chlamydial infection in general practice would be to develop valid guidelines for this condition. At present, no published UK chlamydia guidelines exist, and the development of such guidelines has been recommended by the CMO's Expert Advisory Group.2
Clinical practice guidelines can improve clinical practice and achieve health gain if they are properly designed and implemented.9–14 Guidelines are valid if, when followed, they lead to the health gains and costs predicted for them.15 Validity can be maximized by: the use of a systematic literature review; and the use of an independent guideline development group including representatives of all key disciplines and making explicit links between the recommendations and the quality of the supporting evidence.13 These criteria have been used by the North of England Evidence-Based Guideline Development Project to develop guidelines for the management of asthma and angina in primary care,16–21 and also inform guidelines developed by the Royal College of General Practitioners on the management of acute low back pain.22
The aim of the Leicestershire Genital Chlamydia Guidelines Project was to develop valid guidelines for the management of genital chlamydial infection in general practice. This paper presents the clinical practice guidelines developed by the multidisciplinary recommendation group. The methods used to develop the guidelines have been reported previously.23
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Methods |
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The process of guideline development had three stages (Table 1
): (i) a postal questionnaire survey was used to determine current knowledge among Leicestershire GPs concerning genital chlamydia and to establish how patients with this infection were managed in primary care;8 (ii) a critical review of the evidence concerning the management of genital chlamydial infection as it relates to British general practice was undertaken (Table 2)3,24; and (iii) the information gained from the critical review and survey was used to develop evidence-based guidelines within a multidisciplinary guideline recommendation group.
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Results |
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The Leicestershire Genital Chlamydia Guidelines25 aim to assist clinical decision-making and to improve the management and referral of patients with genital chlamydial infection found in general practice. The categories of evidence (Table 3
) and the strength of the recommendations (Table 4) are derived from the North of England Evidence-based Guidelines Project.16 The recommendations are in italics.
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Scope of the guidelines
The diagnosis, investigation, drug treatment and referral of adult male and female patients with genital chlamydial infection in general practice.
Making a diagnosis in female patients
Recommendations:.
Testing should be carried out on women in whom there is clinical suspicion of chlamydia (C).5
Such women may present with:
- suspected Pelvic Inflammatory Disease (PID);
- urethral syndrome;
- vaginal discharge not obviously caused by ‘thrush’; or
- another sexually transmitted disease (STD).
Testing should also be considered when a women has a vaginal examination for whatever reason (e.g. cervical smear) and the following signs are noted on vaginal examination (C)5:
- mucopurulent cervicitis (MPC); and
- cervix bleeds easily.
If a diagnosis of chlamydia is suspected then the following information should be obtained from the patient (C):
- age (an age of under 25 years is a risk factor for chlamydia);
- sexual history (change of sexual partner within the last 2–3 months is a risk factor for chlamydia);
- contraceptive use (not using a barrier method of contraception is a risk factor for chlamydia); and
- parity (never having been pregnant is a risk factor for chlamydia).
The presence of one or more risk factors should raise the level of clinical suspicion of infection.3
Testing should be carried out on women prior to Termination of Pregnancy (TOP) (B).3
Testing for chlamydia should be considered when a woman presents for emergency contraception (either oral contraceptive pill or intrauterine device (IUD)). A full history should be taken to determine whether any of the above risk factors apply. The presence of one or more risk factors should raise the level of clinical suspicion of infection (C).
The routine ‘pill check’ (oral contraceptive follow-up) offers an opportunity to establish in sexually active women whether there are present any symptoms suggestive of chlamydia infection or the risk factors listed above (C).
The introduction of a screening programme to test sexually active women for genital chlamydia infection cannot be recommended (C).3
Making a diagnosis in male patients
Recommendation:.
Testing should be carried out on men in whom there is clinical suspicion of chlamydia (C).5
Such men may present:
- with urethral discharge and/or dysuria;
- with epididymitis (when aged under 35 years); or
- as a partner of a woman with proven PID.
Testing for chlamydial infection
Recommendations:.
The procedure for specimen collection outlined in Table 5 should be followed (C).
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Drug treatment
Recommendations:. All patients with proven chlamydial infection should be treated with one of the antibiotic regimens listed in Table 6
(A). All these antibiotics have been shown to be effective (I).26–29
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If there is any suspicion that the patient may have difficulty complying with medication, then azithromycin is the drug of choice (B).30,31
Complicated chlamydial infection presents as Pelvic Inflammatory Disease (PID) in women and epididymitis in men. If either of these conditions are suspected then drug treatment should be given, as detailed in Table 7 (C).32
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Treatment should be initiated at the time of testing (presumptive treatment) for the following conditions (C).5
Men:
- symptoms of non-gonococcal urethritis; and
- epididymitis in men < 35 years old.
Women:
- suspected PID.
Men and Women:
- known gonococcal infection;
- partner of person with known chlamydial infection; and
- parents of baby with known chlamydial ophthalmia neonatorum.
Follow-up
Recommendations:.
Drug treatment can be started in primary care (C).
Patients who test positive for genital chlamydia in general practice should be referred to a genitourinary medicine (GUM) clinic for follow-up (C).
Referral to GUM is advocated on the following grounds:
- full counselling service available (risk reduction advice);
- screening for other STDs can be performed (chlamydia can co-exist with other STDs); and
- GUM clinics can provide contact tracing, thus ensuring that partners are treated.
If a patient is unwilling to attend a GUM clinic then the following management strategy is recommended (C)5,32:
- give patient advice about genital chlamydia and other sexually transmitted diseases (STDs) and advise patient to use barrier methods of contraception until the patient and their partner(s) have completed a course of drug treatment;
- ask patient to advise sexual partner(s) of the need to see a doctor to receive anti-chlamydial treatment; and
- partners of patients with genital chlamydia should be tested and treated for chlamydial infection.
It is not necessary to routinely re-test patients (perform a ‘test-of-cure’) to see if infection has cleared.5
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Discussion |
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It is difficult to make a clinical diagnosis of chlamydial infection in female patients, as a large proportion of women are asymptomatic. It is known that the proportion of chlamydial infection detected using a combination of symptoms and the presence of risk factors for infection is low.34 Thus, universal and selective screening programmes have been proposed as a means of controlling infection, particularly in the USA and Scandinavia.35,36 The evidence relating to screening for chlamydial infection is the subject of a recent review.3 As far as universal (‘routine’) screening programmes are concerned, a number of economic evaluation studies suggest that screening for chlamydia is cost-effective when the prevalence is at least 6%.37–41 However, the likely prevalence of infection in UK general practice is lower than this figure (3–4%),3 and the evidence for the effectiveness of routine screening comes from uncontrolled studies (level III evidence).42 It is also uncertain how often routine testing should be repeated. An alternative approach is selective screening, that is to test women who have risk factors for chlamydial infection. There is good evidence from one American RCT that selective screening for chlamydia can reduce the incidence of PID (level I evidence).43 The question is whether these findings can be generalized to a UK general practice population of women. The group appraised the evidence relating to both routine and ‘risk factor’ screening of women,3 and felt that there was insufficient evidence to warrant the setting up of such a programme in the UK at the present time. They were also concerned about making local recommendations in the absence of any national guidance. Although the CMO's Expert Advisory Group recommends opportunistic screening for chlamydia of ‘at risk’ women in general practice, it does not recommend which chlamydia test should be used nor provide detail as to how such a strategy could be implemented.2 The Leicestershire recommendations use Enzyme Immunoassay (EIA) to test for chlamydia. EIA is an invasive procedure that requires endocervical and urethral specimens and so is unlikely to be acceptable as a screening test.44
It is generally agreed that women undergoing TOP should be tested for chlamydia2 or, as an alternative, receive prophylactic antibiotics at induction.45,46 There is evidence from one randomized controlled trial (RCT) that screening women under the age of 25 who request TOP can reduce the frequency of post-abortal PID.47 This study has a number of methodological problems,3 but its findings are consistent with the evidence from several observational studies.48–50 The group felt that it was inappropriate for GPs to test routinely women for chlamydia prior to TOP and that testing should be performed by the gynaecologist at the assessment clinic. The group also felt that the operation letter should state the result of the test and, if positive, whether or not the woman has been referred to a genitourinary medicine clinic for contact tracing. In contrast to TOP, RCTs have yet to be published which show that screening of women prior to IUD insertion leads to a reduction in reported incidence of PID. It is also probable that the prevalence of chlamydia infection in women receiving an IUD in British general practice is low, as these women are likely to be over 25 years old and multiparous.51 The group appraised this evidence and felt that there was insufficient evidence to recommend routine screening in women having their IUD fitted in primary care.3 This recommendation is in accordance with the CMO's Expert Advisory Group report.2
Research suggests that male patients with known or suspected chlamydial infection are infrequently seen in general practice and are less likely to be managed by GPs than are female patients.23 The group felt that it was important that men aged under 35 years admitted under the urologists with a suspected diagnosis of orchitis and/ or epididymitis should be tested for chlamydial infection. This is because chlamydial infection is the commonest cause of epididymitis in this age group.5,52 The group also felt that the discharge letter should state the result of the test and, if positive, whether or not the man has been referred to a genitourinary medicine clinic for contact tracing.
The guidelines are applicable when EIA is used to test for chlamydia. EIA is the most widely used chlamydia test in England and Wales.53 It is recognized that as a diagnostic test EIA has suboptimal sensitivity (greater than 70%).5 Research from genitourinary medicine (GUM) clinics has, however, shown that combining a urethral swab with an endocervical swab increases the yield of positive results with EIA by up to 10%.54 The Leicestershire pathology lab uses Syva Microtrak II EIA and the above recommendations (Table 5
) relate to this testing kit.55,56 Current laboratory practice is to re-test all EIA positives with another test to detect false positives. This improves the specificity of EIA.57 It is recognized that these recommendations will need to be reviewed should the practice of testing for chlamydia infection by DNA-amplification techniques on urine samples be introduced into routine clinical practice. Recent research suggests that these techniques are more sensitive and specific than EIA.58 A urine test for chlamydia would also be non-invasive and would be more acceptable for opportunistic screening of asymptomatic women.44
There is good evidence to support the recommended antibiotic therapy in uncomplicated chlamydial infection (Table 6).26,27 This evidence was used by the Centers for Disease Control (CDC), Atlanta in their 1993 treatment guidelines5,28 and is consistent with the earlier recommendations of the World Health Organisation (WHO).59 The CDC/WHO recommendations are presented here although the advice on treatment during pregnancy has been updated. The recommendation to use amoxycillin as opposed to erythromycin (CDC's first-line treatment) is based on a recent meta-analysis of four RCTs comparing amoxycillin with erythromycin in the treatment of chlamydial cervicitis in pregnant women.29 Cost-effectiveness analysis suggests that azithromycin is more cost-effective than doxycycline in the treatment of chlamydia-positive women.30,31
In contrast, PID presents challenges to researchers who wish to present clear evidence-based advice on diagnosis and treatment.5,60 One particular problem is that most of the research has involved in-patients. It is not known whether these research findings apply to women who are deemed to have mild disease and who are treated in primary care. The dual-dose oral out-patient regimen which is best supported by the evidence is ofloxacin (or clindamycin) plus metronidazole. This regimen is recommended by Centers for Disease Control, Atlanta28 on the basis of a meta-analysis of PID treatment studies published between 1966 and 1992.61 This regimen has recently been endorsed in the UK by a report of the Royal College of Obstetricians and Gynaecologists.46 The treatment recommended (Table 7) is in accordance with British guidelines found in the British National Formulary (BNF) and was the consensus decision of the group. It is likely that this regimen is most familiar to British GPs. It should be noted that the BNF does not specify dosage or duration of therapy.32 Although it is likely that such an approach will cover most organisms, particularly if the likelihood of gonorrhoeal infection is low, this regimen has not been subjected to an out-patient RCT.61 It is therefore important that local patterns of gonorrhoea infection and resistance are known.62
Although it is usual to recommend that patients who test positive for chlamydia in general practice are referred on to GUM clinics for follow-up, there is no published research evidence available comparing the effectiveness of management in each of these two settings.63
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Conclusion |
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Evidence-based guidelines for the management of genital chlamydial infection have been developed for use in British general practice. A key feature of this guideline is that it is valid.23 Appropriate dissemination and implementation of the guidelines14 should lead to earlier detection and treatment of men and women with chlamydial infection and thereby reduce the incidence of PID, tubal infertility and ectopic pregnancy in women.
Copies of the guidelines and critical review of the evidence are available from the authors. The guidelines and an independent critical appraisal can also be accessed on the Guideline web site at: www.ihs.ox.ac.uk/guidelines (Guideline, Public Health Resource Unit, Institute of Health Sciences, Old Road, Headington, Oxford).
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Acknowledgments |
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We should like to thank Dr Pippa Oakeshott, GP, London and lecturer, Division of General Practice and Primary Care, St George's Hospital Medical School, University of London for providing external review of the guidelines.
This guidelines development project originated when TS was a Registrar in Public Health Medicine in the Directorate of Public Health, Leicestershire Health Authority. The guidelines development work was conducted in the Department of General Practice and Primary Health Care at the University of Leicester. The support of Leicestershire Health and the Department of General Practice is gratefully acknowledged. We should also like to thank Richard Baker for his comments on a draft of this paper.
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References |
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