Volume 108, Issue 1 , Pages 4-6, January 2010
Colposcopy audit for improving quality of service in areas with a high incidence of cervical cancer
Article Outline
- Abstract
- 1. Introduction
- 2. Materials and methods
- 3. Results
- 4. Discussion
- 5. Conflict of interest
- References
- Copyright
Abstract
Objective
To audit routine colposcopy performance using 8 standard requirements of the National Health Service Cervical Screening Programme (NHSCSP).
Methods
Records of women who underwent colposcopy for abnormal cervical cytology between January and December 2008 at Chiang Mai University Hospital, Thailand, were reviewed.
Results
The standard requirements were not achieved in 2 practices: (1) the proportion of women who had recordings of visibility of the transformation zone (96.6%) did not achieve the NHSCSP requirement of 100%; and (2) the rate of excisional biopsy (87.8%) was lower than the 95% minimum required.
Conclusion
Colposcopic performance at Chiang Mai University Hospital was generally favorable. However, re-audit is necessary to ensure that unmet standards of performance are improved and achieved standards are maintained.
Keywords: Audit, Colposcopy, Performance, Quality assurance
1. Introduction
Cervical cancer is the most common cancer affecting women in Thailand, with an average age-standardized incidence rate (ASR) of 19.5 per 100
000 women. The highest rate is in the northern province of Chiang Mai, which has an ASR of 25.3. Recent data suggest that the incidence of cervical cancer in Thailand is increasing [1], so there is an urgent need to improve the quality of cervical cancer prevention.
The National Health Service Cervical Screening Programme (NHSCSP), in collaboration with the British Society for Colposcopy and Cervical Pathology, has published guidelines covering a variety of issues regarding quality assurance in cervical cancer prevention, including the standard requirements for colposcopy service [2].
Colposcopy is an integral part of cervical cancer screening; it is commonly performed after the diagnosis of a cervical smear abnormality. The main advantage of colposcopy in women with abnormal cervical cytology is the early detection and treatment of underlying significant cervical lesions [3].
Although routine colposcopy in women with abnormal cervical cytology might be considered a high-cost practice and an overtreatment—particularly for cases in which there are minimal smear abnormalities—in areas such as Thailand with a high incidence of cervical cancer, the benefit of immediate colposcopy outweighs the risk of unnecessary management. The high incidence of significant lesions, especially invasive cancer, is noted across all grades of smear abnormality [4]. Thus, immediate colposcopy enables clinicians to detect and treat such lesions as early as possible.
Medical audits are used by health professionals to evaluate and improve the quality of patient care. Because variations in clinical practice are inevitable, medical audits are of the utmost relevance for ensuring that healthcare services meet or exceed the minimum requirements [5].
Auditing of colposcopy performance highlights unachieved standards and provides an opportunity to improve quality. In Thailand, national guidelines for auditing cervical cancer prevention programs have not been developed.
Based on the successful implementation of the NHSCSP 2004 guidelines [6], these guidelines were used to audit colposcopy performance at Chiang Mai University Hospital, Chiang Mai, Thailand.
2. Materials and methods
In the study institute, data—including patient characteristics, type of abnormal smear, colposcopic findings, and detailed histopathologic results—for women who underwent colposcopy were routinely collected and recorded in the colposcopic database by gynecologic oncology trainees, under direct staff supervision.
After approval from the Research Ethics Committee, the records of all women who underwent colposcopy for abnormal Pap smear between January and December 2008 were reviewed. Women who underwent colposcopy for other indications (e.g. follow-up after treatment or postcoital bleeding) were excluded.
The standard requirements were based on the summary of standards for colposcopy published in the NHSCSP 2004 guidelines [2]: (1) The following data should be recorded at colposcopy: (a) reason for referral (100%); (b) grade of cytologic abnormality (≥90%); and (c) visibility of the squamocolumnar junction (100%); (2) an excisional form of biopsy is recommended (≥95%) when: (a) colposcopic appearances indicate high-grade abnormality; (b) low-grade colposcopic change is associated with severe dyskaryosis or worse; and (c) a lesion extends into the canal; (3) reasons for not performing a biopsy must be recorded (100%); (4) all patients must have a biopsy or biopsies taken prior to local destructive treatment (100%); (5) biopsy should be carried out unless an excisional treatment is planned, when the cytology indicates persisting moderate dyskaryosis or worse, and when atypical transformation zone is present (100%); (6) of all biopsies taken (directed and excisional), more than 90% should be suitable for histologic interpretation; (7) if colposcopically directed biopsy is reported as inadequate for interpretation, it should be repeated if there is a residual colposcopic lesion (≥95%); and (8) for those with satisfactory colposcopic examination, the predictive value of a colposcopic diagnosis of a high-grade lesion should be at least 65%.
Data were summarized as number (percentage) or mean±standard deviation, as appropriate. Statistical analysis was carried out using SPSS version 17 (SPSS, Chicago, IL, USA).
3. Results
During the study period, the records of 266 women who underwent colposcopy for abnormal cervical cytology were reviewed. Mean age was 44.5±11.6years (range, 17–76years). Seventy-two women (27.1%) were postmenopausal, and 42 (15.8%) were nulliparous; mean parity in the 224 parous women was 1.9±0.9 (range, 1–6).
Of the 266 women, 67 (25.2%) had atypical squamous cells of undetermined significance; 30 (11.3%) had “atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion” (ASC-H); 54 (20.3%) had low-grade squamous intraepithelial lesions; 91 (34.2%) had high-grade squamous intraepithelial lesions (HSIL); 12 (4.5%) had squamous cell carcinomas; and 12 (4.5%) had glandular cell abnormalities in their cervical cytology.
Visibility of the transformation zone was recorded in 257 cases (96.6%). In total, 149 women (57.9%) underwent unsatisfactory colposcopy. High-grade lesions were noted in 104 women (39.1%) following colposcopy. One woman with normal colposcopy and negative biopsy results was found, upon endocervical brushing, to have HSIL. Histology following subsequent loop electrosurgical excision procedure (LEEP) revealed cervical intraepithelial neoplasia (CIN) 2–3.
Excisional biopsy was performed on 143 women. In total, 141 excisional biopsies were carried out using LEEP. Cold-knife conization was used for biopsy on 1 woman with atypical glandular cell “favor neoplasia” and 1 woman with adenocarcinoma in situ. Immediate LEEP without intervening biopsy—so-called “see-and-treat” management—was performed on 120 women. Table 1 shows the correlation between preoperative diagnoses and excisional biopsy specimens.
Table 1. Correlation between preoperative diagnoses and excisional biopsy specimens in 143 women. a
| Histology of excisional specimens | |||||
|---|---|---|---|---|---|
| No CIN | CIN 1 | CIN 2–3 | AIS | Cancer | |
| CDB and endocervical evaluation | |||||
| No CIN (n=4) | 2 (50.0) | 1 (25.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) |
| CIN 1 (n=2) | 0 (0.0) | 1 (50.0) | 1 (50.0) | 0 (0.0) | 0 (0.0) |
| CIN 2–3 (n=16) | 1 (6.3) | 0 (0.0) | 13 (81.3) | 0 (0.0) | 2 (12.5) |
| Glandular lesion (n=1) | 1 (100.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Colposcopic impression b | |||||
| No CIN (n=22) | 6 (27.3) | 2 (9.1) | 13 (59.1) | 1 (4.5) | 0 (0.0) |
| CIN 1 (n=9) | 4 (44.4) | 1 (11.1) | 4 (44.4) | 0 (0.0) | 0 (0.0) |
| CIN 2–3 (n=81) | 3 (3.7) | 0 (0.0) | 61 (75.3) | 2 (2.5) | 15 (18.5) |
| MIC (n=1) | 0 (0.0) | 0 (0.0) | 1 (100.0) | 0 (0.0) | 0 (0.0) |
| Not available (n=7) | 1 (14.3) | 0 (0.0) | 4 (57.1) | 1 (14.3) | 1 (14.3) |
aValues are given as number (percentage). |
bWithout intervening histologic examination. |
The histologic diagnoses of the 266 women included CIN 2–3 (40.2%), CIN 1 (13.5%), invasive cancer (7.1%), adenocarcinoma in situ (1.5%), and no intraepithelial lesion (37.6%) (data not shown). During the study period, local destruction using laser ablation was performed on only 1 woman, who had CIN 2–3 on multiple biopsies. Follow-up data were available for 197 women. At the median follow-up time of 7months, CIN 2–3 was diagnosed in an HIV-infected woman who had CIN 1 on initial evaluation (treated with colposcopically directed biopsy with endocervical brushing).
Table 2 shows the level of colposcopy performance at Chiang Mai University Hospital during the study period. The standard requirements were not achieved in 2 colposcopy practices. First, the proportion of women with a recording of visibility of the transformation zone (96.6%) did not achieve the requirement of 100%. Second, the overall rate of excisional biopsy (87.8%) was below the standard requirement of at least 95% for: (1) women for whom colposcopic appearance indicated high-grade abnormality; (2) women for whom low-grade colposcopic change was associated with severe dyskaryosis or worse; and (3) women whose lesion extended into the endocervical canal. However, following stratification according to these 3 circumstances, only the rate of excisional biopsy for women for whom colposcopic appearance indicated high-grade disease (84.6%) was below the required standard. The rate of excisional biopsy for women for whom the severity of colposcopic finding was less than the severity of cytology (97.2%) and for women whose lesion extended into the canal (100%) achieved the standard required.
Table 2. Audit of colposcopy performance at Chiang Mai University Hospital using the NHSCSP 2004 guidelines.
| Requirements (standard required, %) | Audit results, % | Conclusion |
|---|---|---|
| Recording of reason for referral (100) | 100 | Achieved |
| Recording of grade of cytologic abnormality (≥90) | 100 | Achieved |
| Recording of visibility of transformation zone a (100) | 96.6 | Failed |
| Performing excision biopsy under certain circumstances b, c (≥95) | 87.8 | Failed |
| Recording of consent for treatment (100) | 100 | Achieved |
| Recording of reasons for not performing a biopsy (100) | 100 | Achieved |
| Performing a biopsy prior to local destruction (100) | 100 | Achieved |
| Samples suitable for histologic interpretation d (>90) | 93.9 | Achieved |
| Performing repeat biopsy if initial CDB histologically inadequate b (≥95) | 100 | Achieved |
| Correct prediction of high-grade diseases e (≥65%) | 80.0 | Achieved |
aSatisfactory or unsatisfactory colposcopic examination. |
bExcluding pregnant women. |
cWhen colposcopic appearance indicated high-grade abnormality; when low-grade colposcopic change was associated with severe dyskaryosis or worse cytology; and when lesion extended into the endocervical canal. |
dEither directed or excisional biopsies. |
eIn women with satisfactory colposcopy. |
4. Discussion
In the present study, the proportion of women whose records reported visibility of the transformation zone (96.6%) was not at the required level (100%)—a finding that is consistent with results from previous studies [7]. The characteristics of the cervical transformation zone have a significant impact on subsequent management; for example, in women with satisfactory colposcopy who are subsequently found to have CIN 1, the risk of underlying high-grade disease is low and can be followed-up, even in cases in which previous smears revealed HSIL [8]. Additionally, knowing the characteristics of the cervical transformation zone in women who are indicative for excisional treatment could help surgeons to determine the appropriate surgical technique to minimize incomplete excision and possible complications [9]. Therefore, recording the visibility of the cervical transformation zone is crucial.
The rate of excisional biopsy (87.8%) was found to be deficient in the study center. The NHSCSP guidelines state that excisional biopsy should be performed in at least 95% of the following situations: (1) when colposcopic appearance indicates high-grade abnormality; (2) when low-grade colposcopic change is associated with severe dyskaryosis or worse; and (3) when a lesion extends into the canal. Nevertheless, it is important to be cautious because the subjectivity of colposcopy is well acknowledged [10]. Excisional biopsy could be considered an overtreatment if based on colposcopic impression alone, particularly in cases preceded by borderline cytologic abnormalities. Therefore, the diagnosis of high-grade disease would be more accurate if made based on concurrent cytology, colposcopy, and histology results.
In the study institute, directed biopsy and endocervical brushing were performed on all women with cytologic abnormalities who underwent colposcopy. To minimize unnecessary procedure, excisional biopsy was subsequently performed if initial work-up results revealed high-grade disease or worse. See-and-treat LEEP can be performed for women with ASC-H or HSIL [11], [12], [13]. An intention to avoid unnecessary excisional biopsy using this management pattern could explain the low rate of such biopsies in the present study.
Interestingly, although local destruction (ablative treatment) is generally recognized as one of the treatment choices for CIN [14], [15], [16], [17], it was rarely performed in the study institute because: (1) the majority of women with CIN in the study setting had unsatisfactory colposcopic examination, which contraindicates ablative treatment; and (2) owing to the low sensitivity of colposcopy, occult invasive lesions could not be ruled out even after satisfactory examination [12]. Excision could reduce the possibility of some invasive lesions going unnoticed, because the cervical specimens would be examined histologically. This advantage is substantial in areas—such as the study setting—with a high incidence of cervical cancer lesions among women with abnormal cervical cytology [4]. To avoid possible obstetric complications, ablative treatment is reserved for women who plan to become pregnant subsequently [14].
Because there are differences between regions in terms of resource availability, type of healthcare providers responsible for each step, and compliance of patients, the standard measurement criteria for cervical cancer prevention would be most practical when based on individual settings. For example, it would be inappropriate to use the NHSCSP guidelines in most Sub-Saharan African and some Asian countries. Limited resources and lack of staff expertise in colposcopy and cytopathology make achieving these standard performances impossible in these regions.
In conclusion, the NHSCSP requirements were achieved in all but 2 colposcopy practices in the present study: recording visibility of the transformation zone and rate of excisional biopsy. Although these seem to be favorable results, re-audit at an appropriate time is required to ensure that the unmet standards of performance are improved and the achieved standards are maintained. Because a wide range of health professionals is involved in cervical cancer prevention in Thailand, the development of guidelines specifically for national quality assurance in cervical cancer prevention programs is challenging and urgently needed.
5. Conflict of interest
The authors have no conflicts of interest.
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PII: S0020-7292(09)00493-7
doi:10.1016/j.ijgo.2009.07.042
© 2009 International Federation of Gynecology and Obstetrics. Published by Elsevier Inc. All rights reserved.
Volume 108, Issue 1 , Pages 4-6, January 2010
