UK National Audit of Chlamydial Infection Management in Sexual Health Clinics. Case notes audit: demography,diagnosis and treatment

Abstract

Summary

The case notes of cases of genital chlamydial infection were audited against the UK National Guideline. This was the first web-based and the largest national audit to date, with 193 clinics in all UK Regions contributing data. About half of all cases had no symptoms, with about one-third attending for routine or asymptomatic screens; suggesting significant provision of screening by clinics that might be managed differently to reduce workload. Nucleic acid amplification tests (NAATs) are now well established for chlamydial detection in UK clinics, with 93% of cases having genital NAATs. Azithromycin is now more commonly used than doxycycline (54% vs. 37%). Of 26 pregnant women, 20 were treated with azithromycin, suggesting that most prescribers treating pregnant women consider that erythromycin is not an adequate alternative to azithromycin. Most women had NAATs obtained from sites recommended by the Guideline, with 93% of women who had genital NAATs having these from the cervix or vulvovaginal area.

Keywords

clinical audit sexually transmitted diseases female urogenital diseases male urogenital diseases

INTRODUCTION

This paper accompanies the papers on the clinic policies survey¹ and case note audit of information giving contact tracing and follow-up of chlamydial infection management carried out in 2007 by the National Audit Group (NAG).²

OBJECTIVE AND GOAL

The objective was to measure practice performance in the UK Regions against national standards and guidelines, against average UK performances as well as to allow comparisons between Regions and between Trusts within Regions. The study was conducted in Genitourinary Medicine (GU Med) clinics and in Sexual and Reproductive Health-care (SRH) clinics, in the UK. The goal of the audit was to improve the sexual health care of people with chlamydial infection in the UK.

METHODS

The audit methodology and organization was planned by the NAG, involving the chairs of Regional Audit Groups in the UK and an NHS Trust Clinical Audit expert. The guideline audited against was the BASHH UK National Guideline for the Management of Genital Tract Infection with Chlamydia trachomatis ³ (revised July 2006). The case definition was a case ascribed with any one of the KC60 C4A, C4B or ISD(D)5 C41A, C41B or C41R⁴ codes and diagnosed by the auditing clinic within the audit interval. The audit interval was between 2 January and 31 March 2007 inclusively. Data were collected from 3 September to 31 October 2007.

Two on-line audit questionnaires, one on management recorded in case notes and the other on clinic policy regarding chlamydial infection management, and both available on the BASHH website,⁵ were translated into web-based forms. For the case notes audit, the sample number for each centre was the first 30 patients seen in the audit interval (or all cases if <30 seen). Data were submitted on the web-based forms using Feedback Server software⁶ (Data Illusion, Geneva, Switzerland [http://www.dataillusion.com]) and downloaded for analysis using Microsoft Access and Excel (Microsoft Corp, Redmond, WA, USA). Pseudonymized data only were collected. Data were collated and aggregated by Region and by NHS Trusts/Clinics within Regions. This paper reports on regional and national performance. Regional and individual clinic performance data have been disseminated to relevant clinics. All data ranges given are regional ranges.

RESULTS

Demography

Data were contributed by 193 clinics (including six SRH clinics) that provided pseudonymized data on 5032 cases from all 14 English BASHH regions (mostly corresponding to Strategic Health Authorities) and Scotland, Wales and northern Ireland. The 14 English Regions were reduced to 12 Regions by North Thames including Essex, and south-west and south-east London grouped together as South Thames. For the corresponding time interval, there were 4408 (18%) of 24,870 English cases,⁷ 307 (7%) of 4466 Scottish cases,⁸ 287 (40%) of approximately 756 Welsh cases⁹ and 30 (6%) of 474 of northern Irish cases¹⁰ sampled.

A total of 2546 (51%, regional range 46–60%) were men, of whom 2365 (93%, range 85–98%), 162 (6%, range 2–12%) and 19 (1%, range 0–5%) were heterosexual, men who have sex with men and unknown sexuality, respectively. There were 2474 (49%, 39–54%) female cases, of whom 26 (1%, 0–3%) were pregnant. Gender was not known for 12 (0.2%, regional range 0–1.5%).

The age distribution was <16 years: 88 (2%, 0–4%); 16–18 years: 801 (16%, 12–23%); 19–24 years: 2489 (50%, 41–60%); 25–34 years: 1263 (25%, 20–31%); 35–44 years: 284 (6%, 2–8%); 45–54 years: 77 (2%, 0–3%); 55–64 years: 20 (0.4%, 0–1%); >65 years: one (0.02%, 0–0.1%) and age was not known for nine (0.2%, 0–2%). The breakdown of ethnicity was: White: 3929 (78%, 58–98%); Black Caribbean: 211 (4%, 0–12%); Black African: 124 (2%, 0–6%); Black Other: 84 (2%, 0–7%); Chinese/south-east Asian: 36 (0.7%, 0–1%); Indian: 32 (0.6%, 0–2%); Pakistani: 29 (0.6%, 0–2%); Bangladeshi: 10 (0.2%, 0–1%); Hispanic: 10 (0.2%, 0–2%); Arabic: seven (0.1%, 0–1%); other: 153 (3%, 0–8%) and not known: 407 (8%, 0–32%).

Reason for testing for chlamydial infection and presenting features

The reason(s) for testing for chlamydial infection were as follows: symptoms: 2317 (46%, range 38–53%); routine screening/asymptomatic check-up: 1707 (34%, range 27–42%); contact of partner diagnosed with chlamydia: 1135 (23%, range 18–28%); based on sexual history: 784 (16%, range 3–31%); medicolegal case: five (0.1%, range 0–0.6%) and not documented: 23 (0.5%, range 0–3%). Presenting feature(s) for female cases were recorded as follows: no symptoms: 1273 (52%, range 43–60%); vaginal discharge: 690 (28%, range 18–35%); lower abdominal pain: 306 (12%, range 6–19%); dysuria: 205 (8%, range 4–14%); postcoital or intermenstrual bleeding: 178 (7%, range 0–10%); mucopurulent cervicitis and/or cervical contact bleeding: 82 (3%, range 0–7%); complications of chlamydial infection (defined as pelvic infection, ectopic pregnancy, infertility and chronic pelvic pain): 31 (1%, range 0–3%); conjunctivitis: six (0.2%, range 0–0.7%); pharyngeal symptoms: one (0.04%, range 0–0.5%) and other symptoms: 263 (11%, range 3–31%). Presenting feature(s) for male cases were recorded as follows: no symptoms: 1175 (46%, range 31–50%); dysuria: 858 (34%, range 28–50%); urethral discharge: 685 (27%, range 23–30%); rectal symptoms: 19 (0.8%, range 0–2%); low abdominal pain: 17 (0.7%, range 0–2%); conjunctivitis: eight (0.3%, range 0–1%); pharyngeal symptoms: three (0.1%, range 0–0.8%) and other symptoms: 325 (13%, range 8–24%).

Diagnostic tests

Table 1 shows the number of cases tested using nucleic acid amplification tests (NAATs) based on specimen type. Overall, 4679 (93%, regional range 69–100%) cases had NAATs documented from at least one of the urinary, cervical, vulvovaginal, urethral or rectal sampling. Overall, 359 (7%, regional range 0–32%) cases had enzyme immunoassay (EIA) testing documented from at least one of the urinary, cervical, vulvovaginal, urethral or rectal sampling. The following numbers of cases were tested using EIA in women: cervical—218 (9%, 0–35%); urethral—173 (7%, 0–34%); vulvovaginal—12 (0.5%, 0–7%); urine—one (0.04%, 0–0.25%) and throat—two (0.1%, 0–0.5%); in heterosexual men: urethral—118 (5%, 0–21%); urine—10 (0.4%, 0–7%) and throat—one (0.04%, 0–0.28%) and in homosexual men only a total of six EIA tests were done. The following number of women was tested using tissue culture: cervical—42 (1.7%, 0–11%); vulvovaginal—40 (1.6%, 0–9%); urethral—33 (1.3%, 0–9%); urine—8 (0.3%, 0–5%) and throat—seven (0.3%, 0–1.5%). A total of 53 (2.2%, 0–10%) heterosexual men had urethral tissue culture tests, with tissue culture used for other sites in four heterosexual men. A total of 23 tissue culture tests were done in homosexual men. Only a total of four, two and three direct immunofluorescence assays were done for women, heterosexual men and homosexual men, respectively. Overall, 2093 (85%) women had cervical or vaginal NAATs; of the remaining 381 not having cervical or vaginal NAATs, 134 (35%) had urine NAATs (of whom 52 [39%] had a genital examination performed), 18 (5%) had urethral NAATS and 229 (60%) had no cervical, vulvovaginal, urinary or urethral NAATs. Overall, 1723 (68%) men had urinary NAATs; of the remaining 823 not having urinary NAATs, 699 (85%) had urethral NAATs and 124 (15%) had neither urinary nor urethral NAATs.

Table 1

Numbers of cases tested for chlamydial infection with nucleic acid amplification tests according to specimen types

Patient group (n)	Specimen type
Patient group (n)	Urine	Cervix	Vulvovaginal	Urethra	Rectum	Throat	Eye
Female (n = 2474)	198 (8, 0–26)	2011 (81, 65–100)	186 (8, 0–23)	422 (17, 0–62)	17 (0.7, 0–2)	13 (0.5, 0–3)	3 (0.1, 0–0.5)
Heterosexual men (n = 2365)	1601 (68, 34–100)	NA	NA	771 (33, 0–67)	None	4 (0.2, 0–1%)	3 (0.1, 0–0.6)
Homosexual men (n = 162)	107 (66, 0–100)	NA	NA	58 (36, 0–100)	89 (55, 0–100)	34 (21, 0–64)	1 (0.6, 0–12)

NA = not applicable

Note: Values are expressed as the number of cases (% of No., % regional range)

Testing for HIV was carried out for the following numbers of women, heterosexual and homosexual men, respectively: 1609 (65%, 54–92%), 1580 (67%, 56–100%) and 118 (73%, 58–100%). Testing for syphilis was carried out for the following numbers of women, heterosexual and homosexual men, respectively: 1668 (67%, 56–92%), 1668 (71%, 61–100%) and 141 (87%, 75–100%). Testing for hepatitis B was carried out for the following numbers of women, heterosexual and homosexual men, respectively: 438 (18%, 5–39%), 432 (18%, 6–50%) and 85 (52%, 33–100%). Testing for other sexually transmitted infections was carried out for the following numbers of women, heterosexual and homosexual men, respectively: 2336 (94%, 76–100%), 2208 (93%, 81–99%) and 158 (98%, 67–100%). Genital examination was carried out for the following numbers of women, heterosexual and homosexual men, respectively: 2258 (91%, 75–100%), 2153 (91%, 85–91%) and 153 (94%, 67–100%).

Treatment

Overall, 4673 (93%) cases received the following first line treatments (all oral) recommended by the National Guidelines for chlamydial infection (three cases received more than one of these treatments): single dose azithromycin 1 g, 2712 (54%, 16–90%) cases; doxycycline 100 mg twice daily for seven days, 1868 (37%, 0–79%) cases; erythromycin 500 mg twice daily for 10–14 days, 75 (1.5%, 0–4%) cases; erythromycin 500 mg four times daily for seven days, 12 (0.2%, 0–1%) cases; ofloxacin 200 mg twice daily for seven days, three (0.1%, 0–0.4%) cases; ofloxacin 400 mg twice daily for seven days, six (0.1%, 0–0.5%) cases. Overall, 4579 (91%, 76–95%) cases were treated with either first line azithromycin 1 g as a single dose or doxycycline 100 mg twice daily for seven days. A further 23 cases received recommended treatments, although these were reported as second line treatments when no first line treatment was reported.

Other non-recommended treatments for uncomplicated chlamydial infection were reported for 146 (3%) cases: doxycycline 100 mg twice daily for 14 days (68 cases), doxycycline 200 mg once daily for 10 days (46 cases), doxycycline 100 mg twice daily for 21 days (four cases), doxycycline 200 mg twice daily for 28 days (one case), doxycycline 200 mg once daily for 14 days (one case), doxycycline 100 mg (dosing not specified) for 14 days (one case), doxycycline 100 mg twice daily six days (one case in treated in primary care), ofloxacin 400 mg twice daily for 14 days (five cases), ofloxacin 400 mg once daily for five days (two cases), ofloxacin 400 mg twice daily for five days (one case), azithromycin oral suspension 1200 mg at once (three cases), azithromycin 500 mg daily for five days (one case), azithromycin not specified (one case), erythromycin 250 mg four times daily for 14 days (three cases), erythromycin 250 mg four times daily for seven days (three cases), erythromycin 500 mg four times daily for 10 days (one case), erythromycin not specified (one case), minocycline 100 mg twice daily for 14 days (one case), clindamycin 300 mg twice daily for one week (one case) and doxycycline 100 mg twice daily per rectum for 21 days (one case). Eighty-three cases received a treatment for complicated infection that did not include a treatment for uncomplicated infection. Overall, no treatment was documented for 97 (2%) cases and four were reported as not treated. An additional six cases had been treated elsewhere. Hence, excluding the 83 cases treated only for complicated infection and six cases treated elsewhere, 4696/4943 (95%) cases were treated with a recommended treatment. There were no reports of treatments with amoxycillin, Deteclo^® or oxytetracycline. Of the 26 pregnant women, 20 were treated with 1 g single dose azithromycin, two with erythromycin 500 mg twice daily for 10–14 days, two with erythromycin 500 mg four times daily for seven days, one with erythromycin 250 mg four times daily for seven days and treatment was not recorded for one case.

A specific question on treatment for pelvic infection was asked and treatments for 102 cases of pelvic infection were reported. Of these, 63 treatments were with doxycycline (51 with 100 mg b.i.d. for 14 days, eight with 100 mg b.i.d. for 10 days and four treatments where the regimen was not clear); of these, 46 included treatment with metronidazole. Only 14 of the doxycycline and metronidazole treatments were with a cephalosporin (11 with i.m. ceftriaxone and three with oral cefixime). Ten treatments were with metronidazole only. In addition, the following treatments were reported for pelvic infection: 19 with ofloxacin (18 for 14 days, one for 10 days and 18 with metronidazole for five to 14 days and one without metronidazole; none of the ofloxacin treatments were with a cephalosporin), two with a single dose of azithromycin and metronidazole, two with erythromycin and metronidazole, one with amoxycillin and azithromycin, one with cefixime 400 mg plus doxycycline 100 mg twice daily for seven days, one with a single dose of azithromycin 1 g followed by 500 mg twice daily for five days, one with levofloxacin and metronidazole and inpatient treatment was not known for two cases. The following treatments for 31 cases of epididymitis were reported: doxycycline 100 mg twice daily for 14 days (20 cases), doxycycline 100 mg twice daily for 21 days (three cases), doxycycline 100 mg twice daily for 28 days (one case), doxycycline 200 mg twice daily for 14 days (one case), ofloxacin 400 mg twice daily for 14 days (two cases), ofloxacin 400 mg once daily for 14 days (one case) ofloxacin 400 mg twice daily for 14 days plus metronidazole (one case), ofloxacin 200 mg twice daily for 14 days (one case) and ofloxacin 200 mg twice daily for 14 days plus metronidazole (one case).

Overall, 2650 (53%, 42–67%) cases were treated during the same visit as when the chlamydial test was taken. Of these, 1042 (39%) were sexual contacts of a chlamydial case; of the remaining 1608 cases, 1092 (68%) were male cases. In addition, the following timings for treatment were reported (note that more than one of these was possible): previously treated at the clinic for non-specific infection, 424 (8%, 0–16%) cases; after the date when the chlamydia swab was taken: 2127 (42%, 29–56%); at the time of final attendance: 609 (12%, 6–24%); not treated (recalled, but failed to attend for treatment): 44 (1%, 0–3%); not documented when treated: 14 (0.3%, 0–1%) and not known when treated: 34 (0.7%, 0–3%).

DISCUSSION

This was the first BASHH NAG audit to collect data using on-line forms, and more clinics provided data than in previous national audits, supporting this method of performing an audit.

About half of all cases had no symptoms, with about one-third attending routine or asymptomatic screening, suggesting significant overall provision of screening by participating clinics.

NAATs for chlamydia are now well established in the UK clinics, with 93% of cases having genital chlamydial NAATs when compared with 55% in the 2004 UK national audit of chlamydia infection management.¹¹ Conversely, EIA testing is much less common in this audit when compared with the 2004 audit (7% vs. 62% cases). The testing sites for most female NAATs were in keeping with the current National Guidelines (that cervical or vulvovaginal swabs are the ‘specimens of choice’) with 2093 (93%) of 2245 women who had genital NAATs having these tests from the cervix or vulvovaginal area. The National Guideline recommends either urinary or urethral NAATs for men, and most men (71%) having these tests done had urinary NAATs.

In this audit, 95% of eligible cases received a National Guideline recommended treatment compared with 99% of cases who received an appropriate treatment during the 2004 Audit. There is significantly greater use of single dose azithromycin 1 g when compared with the recommended doxycycline regimen in this audit (54% vs. 38%), the reverse of the 2004 Audit finding of 37% versus 55%, respectively. Generic azithromycin became available between these two audits, making the cost of the two drugs similar. Of 26 pregnant women, 20 were treated with azithromycin as recommended by the National Guideline, suggesting that most prescribers treating pregnant women consider that erythromycin is not an ‘adequate alternative’ to azithromycin (the manufacturer's advice stated by the British National Formulary¹²). Almost 70% of cases treated during the same visit as when the chlamydial test was taken, and who were not chlamydial contacts, were men. This suggests that clinical features and/or microscopy may have been more important in influencing immediate treatment in men when compared with women; only 82 (3%) women were reported as having cervicitis (physical signs in men and microscopy findings were not enquired after in the audit).

Only 29 (28%) of 102 treatments for pelvic infection could be said to have followed the BASHH Guideline for the treatment of pelvic infection (either doxycycline plus metronidazole plus an i.m. cephalosporin or ofloxacin plus metronidazole, for recommended durations).¹³ This is in contrast to the mainly adequate treatments reported for epididymitis. There has been little previous multidistrict audit of pelvic infection treatment, although an audit of Yorkshire clinics also suggested suboptimal treatment for pelvic infection.¹⁴

Overall, the 60% national target¹⁵ (by the end of 2007) of uptake of HIV testing for reducing undiagnosed HIV in GU Med clinics would have been met for women, heterosexual men and homosexual men. However, there were wide ranges of performance in the uptake of these tests (around 50–100%) and performance for these groups fell below the 60% level for three, three and one Region(s), respectively.

SUGGESTED AREAS FOR PRACTICE IMPROVEMENT/INTERVENTIONS

The significant workload presented to clinics by cases without symptoms attending for routine check-ups might be reduced by review of management systems, e.g. by closer working with local Chlamydia Screening Programmes. As recommended by the National Guideline, NAATs are well established for the detection of chlamydial infection in sexual health clinics. Clinics still using EIA tests should change to NAATs. The apparent suboptimal treatment of pelvic infection requires improvement, perhaps by raising awareness of the BASHH Guideline on the treatment of pelvic infection and more multidistrict audit of the treatment of pelvic infection. Some Regions need to improve uptake of HIV testing. Regional audit groups should compare practice between clinics, and learn which practice is associated with good performance according to the National Guideline.

Detailed data, aggregated by regions, are available on the BASHH website: [http://www.bashh.org/committees/nag/index.htm]

Footnotes

ACKNOWLEDGEMENTS

The work done by all NHS staff who submitted data and supported the audit is gratefully acknowledged. The work done by those running the pre-pilot and pilot phases is gratefully acknowledged: Chris Carne, Paul Bunting, Arnold Fernandes, Jyoti Dhar, Steve Estreich, Sumit Bhaduri, Hugo McClean, David Daniels. The work done by the Regional Chairs and staff in NHS Trusts/Clinics is gratefully acknowledged. Membership of NAG, April 2007: David Daniels (Chair), Chris Carne (Honorary Secretary), Hugo McClean (Director of Development), Raymond Maw (northern Ireland and BCCG Chair), Ed Wilkins (BHIVA Representative), TC Harry (Anglia), Dwight Coelho (Essex), Ravindra Gokhale (Merseyside), Ann Sullivan (N Thames), Eva Jungmann (N Thames), Sarup Tayal (northern), Ashish Sukthankar (north-west), Adil Isaac (Oxford), Steve Baguley (Scotland), Arnold Fernandes (south-west), Cindy Sethi (south-east Thames), Steven Estreich (south-west Thames), Jyoti Dhar (Trent), Helen Bailey (Wales), Sarah McAndrew (Wales), Reena Mani (Wessex), Sumit Bhaduri (West Midlands), Ian Fairley (Yorkshire), Paul Bunting (Co-opted Member), Irene Vaughan (Co-opted Member) and Mike Walzman (Co-opted Member). The advice and support of Hilary Curtis in designing the on-line questionnaires and in collecting, processing and tabulating the audit data into national aggregates and regional aggregates is gratefully acknowledged.

References

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