Background Guidelines exist for the management of endometriosis. Validated and reliable appraisal tools exist to assess the quality of guidelines. Objectives To systematically appraise the quality of guidelines for the management of pelvic pain associated with endometriosis. Search strategy Guidelines were identified using a prospective protocol through a systematic search of MEDLINE (1951–2005), EMBASE (1974–2005), the Cochrane Library (2005, issue 2), known guideline websites and the World Wide Web. Selection criteria Type of document: guideline, consensus statement, care protocol or healthcare technology assessment produced by national or international professional organisations and societies or governmental agencies; subject: managemant of pelvic pain associated with endometriosis. Data collection and analysis Two validated appraisal tools, Cluzeau and The Appraisal of Guidelines and Research and Evaluation (AGREE), were used to quantitatively assess the quality of guidelines. Areas evaluated included ‘rigour of development’, ‘context and content’ and ‘application.’ Main results Eight of 596 potentially relevant citations identified met our inclusion criteria. The Cluzeau instrument quality score were the following: rigour of development, 53% (range 5–65%); context and content, 69% (range 29–79%) and application 20% (range 0–20%). The aplication dimension achieved significantly lower quality scores (P = 0.026 versus rigour of development and P = 0.017 versus context and content). The AGREE instrument quality scores were the following: scope and purpose, 68% (range 17–89%); stakeholder involvement, 33% (range 13–63%); rigour of development, 49% (range 10–81%); clarity of presentation, 55% (range 42–67%); applicability, 14% (range 0–28%) and editorial independence, 28% (range 8–67%). The applicability domain achieved significantly lower quality scores (P = 0.001 versus scope and purpose and P = 0.009 versus rigour of development). Author’s conclusions Guidelines for the management of pelvic pain associated with endometriosis do not comply with the recommendations for high‐quality standards.
Radical hysterectomy and pelvic lymphadenectomy is the standard surgical treatment for early stage cervical cancer. This operation is well recognised as having a higher morbidity and mortality rate than a simple hysterectomy. We studied the histology results of 131 patients who had standard surgery for cervical cancer to ascertain if a radical hysterectomy was required for adequate treatment. Of 110 (84%) patients with negative pelvic lymphadenopathy, only 9 (8%) had positive parametrial histology and all required adjuvant therapy independent of their parametrial histology. This study confirms that a less radical hysterectomy and pelvic lymphadenectomy provides adequate treatment and allows us to consider a more conservative, minimal access approach to the management of these patients.
Objective. To determine the accuracy of minimally and non-invasive tests to assess the groin node status in squamous cell vulvar cancer.Methods. A systematic review of published research from 1979 to 2004 that compares the results of tests to determine groin node status with histology at inguinofemoral lymphadenectomy was made. Studies included in the review were those that compared the index test to the standard surgical intervention of inguinofemoral lymphadenectomy and allowed the construction of two-by-two tables. From these tables, sensitivity, specificity, and the likelihood ratios (with 95% confidence intervals) were reported and, where feasible, meta-analysis was used to pool results for each test separately. Sentinel node biopsy using technetium-99m-labelled nanocolloid (Tc-99m) had a pooled sensitivity and negative LR of 97% (91-100 95% CI) and 0.12 (0.053-0.28 95% CI), respectively, and was the most accurate test reviewed.Conclusion. Five diagnostic tests were identified in a total of 29 studies (961 groins). Although the studies were small and the design often poor, this represents the best summary of the data to date. Sentinel node identification using Tc-99m appeared to be the most promising test for accurately excluding lymph node metastases in squamous cell vulvar cancer and potentially reducing the radicality of surgery. Its efficacy as a tool in reducing the need for radical surgery and associated patient morbidity without reducing survival needs further assessment probably in a randomised control trial. (c) 2005 Published by Elsevier Inc.
Infection with high-risk genital human papillomavirus (HPV) types is a major risk factor for the development of cervical intraepithelial neoplasia (CIN) and invasive cervical carcinoma. The design of effective immunotherapies requires a greater understanding of how HPV-specific T-cell responses are involved in disease clearance and/or progression. Here, we have investigated T-cell responses to five HPV16 proteins (E6, E7, E4, L1 and L2) in women with CIN or cervical carcinoma directly ex vivo . T-cell responses were observed in the majority (78%) of samples. The frequency of CD4+ responders was far lower among those with progressive disease, indicating that the CD4+ T-cell response might be important in HPV clearance. CD8+ reactivity to E6 peptides was dominant across all disease grades, inferring that E6-specific CD8+ T cells are not vitally involved in disease clearance. T-cell responses were demonstrated in the majority (80%) of cervical cancer patients, but are obviously ineffective. Our study reveals significant differences in HPV16 immunity during progressive CIN. We conclude that the HPV-specific CD4+ T-cell response should be an important consideration in immunotherapy design, which should aim to target preinvasive disease.
In the field of gynecological oncology, there has recently been a rapid growth in the development of new tests designed to improve the diagnosis and stage of both preinvasive and invasive disease. Research on these tests is presented to clinicians in the form of diagnostic accuracy studies, which generate a comparison of measurements made by the index test against those of an accepted reference standard test—the “gold standard”. This allows an assessment of the accuracy of the index test, often expressed as sensitivity and specificity, likelihood ratios, diagnostic odds ratio, or area under a receiver–operator characteristics (ROC) curve. Using this information enables judgements to be made relating to the potential suitability of new tests for clinical practice. In order to avoid errors in judgement, it is important that the report of the study allows for the detection of any biases by providing a complete and transparent description of the study participants, methodology, and results. Guidelines for the reporting of other study types have been widely accepted, for example, CONSORT [ [1] Moher D. Schulz K.F. Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med. Res. Methodol. 2001; 1: 2 Crossref PubMed Scopus (523) Google Scholar ], for randomized control trials and QUORUM [ [2] Moher D. Cook D.J. Eastwood S. Olkin I. Rennie D. Stroup D.F. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta-analyses. Lancet. 1999; 354: 1896-1900 Abstract Full Text Full Text PDF PubMed Scopus (4004) Google Scholar ], and MOOSE [ [3] Stroup D.F. Berlin J.A. Morton S.C. Olkin I. Williamson G.D. Rennie D. et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000; 283: 2008-2012 Crossref PubMed Scopus (16541) Google Scholar ], for systematic reviews. There is now a format for reporting evaluations of tests called Standards for Reporting of Diagnostic Accuracy (STARD) [ [4] Bossuyt P.M. Reitsma J.B. Bruns D.E. Gatsonis C.A. Glasziou P.P. Irwig L.M. et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ. 2003; 326: 41-44 Crossref PubMed Scopus (1185) Google Scholar ].
Human papillomavirus (HPV)‐associated vulvar intraepithelial neoplasia (VIN) has serious sequelae for the sufferer. Current treatments are associated with poor response and high relapse rates. The development of HPV‐specific T cell immunotherapies offers a new approach to treatment. This will require a detailed understanding of the spectrum of T cell responses induced by HPV antigens, and how effectively viral antigens can be accessed by the immune system. We have investigated the frequency and spectrum of HPV16‐specific CD8+ T cell responses to three HPV16 antigens in 9 women with high grade VIN (VIN3). CD4‐depleted populations of responder cells were screened against overlapping 30–35mer peptides covering the sequences of HPV16 E6, E7 and E4 using ELISPOT assays of IFN‐γ release. We demonstrated CD8+ T cell reactivity to one or more of the proteins in 6 of 9 patient samples. All 6 of these responders recognised peptides covering the E7 protein, 3 of 9 women responded to E6 peptides, but no reactivity was seen to E4. Our results suggest that HPV16‐specific cytotoxic T cells (CTLs) are relatively common in women with persistent VIN3. The HPV‐specific CTL response, however, seems to be ineffective. There is some evidence that there are problems associated with the processing and presentation of HPV antigens by the infected vulvar epithelium. It will be crucial to address this in the design of any T cell based therapy for HPV‐associated VIN and vulval cancer. © 2003 Wiley‐Liss, Inc.
Objective To determine the accuracy of outpatient endometrial biopsy in diagnosing endometrial cancer in women with abnormal uterine bleeding.Design A systematic quantitative review of published research.Methods Studies were selected if accuracy of outpatient endometrial biopsy was estimated compared with a reference standard. Diagnostic accuracy was determined by pooled likelihood ratios for positive and negative test results. There were 1013 subjects in 13 diagnostic evaluations reported in 11 primary studies.Results A positive test result on outpatient biopsy diagnosed endometrial cancer with a pooled likelihood ratio of 66.48 (95% CI 30.04-147.13) while a negative test result had a pooled likelihood ratio of 0.14 (95% CI 0.08-0.27). The post test probability of endometrial cancer was 81.7% (95% CI 59.7%-92.9%) for a positive test and 0.9% (95% CI 0.4%-2.4%) for a negative test.Conclusion Outpatient endometrial biopsy has a high overall accuracy in diagnosing endometrial cancer when an adequate specimen is obtained. A positive test result is more accurate for ruling in disease than a negative test result is for ruling it out. Therefore, in cases of abnormal uterine bleeding where symptoms persist despite negative biopsy, further evaluation will be warranted.
Objective To develop a simple but sensitive instrument to evaluate and document symptoms of both bowel and urinary dysfunction in women.Design A 22-item questionnaire covering a range of bowel and urinary symptoms was developed and underwent rigorous psychometric testing.Setting The gynaecology departments of three hospitals, a urogynaecology clinic, a functional bowel clinic and a general practice.Population Six hundred and thirty women, comprising four groups: 1. women awaiting hysterectomy (n = 379), 2. women following hysterectomy (n = 45), 3. women referred with functional bowel and/or urinary symptoms (n = 65), 4. asymptomatic controls (n = 141).Main outcome measures The content, construct and criterion validity, internal consistency, reliability and responsiveness of the questionnaire were measured.Results Peer and patient reports and missing data patterns supported face and content validity. Factor analysis showed a clinically relevant four-factor structure with low content replication able to distinguish between patient groups, indicating good internal structure. Comparison with clinical, anorectal physiological, videoproctographic, transit time and urodynamic test results provide provisional indication of criterion validity. Key domain question analysis and Cronbach's alphas showed internal consistency. Kappa values demonstrated good test-retest reliability and key question correlation over time proved responsiveness.Conclusions Our findings support the suitability, clinical validity, reliability and responsiveness of a simple questionnaire, which is sensitive to the constraints of clinical practice. The authors recommend its use in health care evaluation research assessing the effects of pelvic surgery and as a useful tool in comparing treatment efficacy.
Background. To determine the accuracy of outpatient endometrial biopsy in diagnosing endometrial hyperplasia in women with abnormal uterine bleeding.Design. Systematic quantitative review of published medical literature.Data sources. Relevant papers were identified through electronic scanning of MEDLINE (1980–1999) and EMBASE (1980–1999), manual searching of bibliography of known primary and review articles and contact with manufacturers.Review methods. Studies were selected if accuracy of outpatient endometrial biopsy, in women with abnormal pre or postmenopausal uterine bleeding, was estimated compared to a reference standard, which was endometrial histology obtained by tissue sampling under anesthesia. Quality assessment and data extraction were performed in duplicate. Diagnostic accuracy was determined by pooled likelihood ratios (LR) for positive and negative test results for endometrial hyperplasia.Results. There were 881 subjects in 8 diagnostic evaluations reported in 6 primary studies. Postmenopausal women represented 25% of the participants studied. There were 43 patients in whom outpatient sampling was inadequate. A positive test result on outpatient biopsy diagnosed endometrial hyperplasia with a pooled LR of 12.0 (95% CI 7.8–18.6) while a negative test result had a pooled LR of 0.2 (95% CI 0.1–0.3). With a positive test result, the posttest probability of endometrial hyperplasia was 57.7% (95% CI 41.1%–72.7%) while it was 2.2% (95% CI 0.9%–4.1%) with a negative test.Conclusion. Outpatient endometrial biopsy has modest accuracy in diagnosing endometrial hyperplasia. Therefore, additional endometrial assessment should be undertaken, especially if symptoms persist or intrauterine structural abnormalities are suspected.
Objectives: To develop an evidence based protocol for the follow up of women with low grade cervical abnormalities for whom treatment is not immediately indicated. Design: Population outcome study. Setting: Colposcopy clinic of an inner city teaching hospital. Participants: 566 women with low grade cytological abnormalities who were not treated at a first visit to the colposcopy clinic, followed up for a total of 881 years. Main outcome measures: Resolution of abnormalities, persistence of disease, and treated disease. Results: Abnormalities resolved in 306 (54.1%) women, whereas 138 (24.4%) had persistent disease and 122 (21.5%) were subsequently treated. Colposcopic opinion, smear test results, age, smoking history, and number of pregnancies were all significantly related to outcome. Logistic regression analysis produced a model that correctly identified 70% of women whose abnormalities resolved. Only 23 of 295 women (7.8%) with a normal cervix on colposcopy and a smear without dyskaryosis at a first visit were treated by the end of the observation period. Conclusions: Women referred with low grade cytological abnormalities who have a normal cervix on colposcopy and a negative or borderline repeat smear test result may be discharged from the colposcopy clinic. We propose a follow up protocol that could safely avoid unnecessary visits to a clinic.
International Journal of Gynecology & ObstetricsVolume 70, Issue S2 p. B21-B21 Free communication The colposcopic surveillance of women with low-grade cytological abnormalities: An outcome analysis providing evidence-based follow-up protocols G.R. Teale, G.R. TealeSearch for more papers by this authorD.D. Moffitt, D.D. MoffittSearch for more papers by this authorC.H. Mann, C.H. MannSearch for more papers by this authorD.M. Luesley, D.M. LuesleySearch for more papers by this author G.R. Teale, G.R. TealeSearch for more papers by this authorD.D. Moffitt, D.D. MoffittSearch for more papers by this authorC.H. Mann, C.H. MannSearch for more papers by this authorD.M. Luesley, D.M. LuesleySearch for more papers by this author First published: 10 December 2003 https://doi.org/10.1016/S0020-7292(00)86145-7AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume70, IssueS22000Pages B21-B21 RelatedInformation
BJOG: An International Journal of Obstetrics & GynaecologyVolume 106, Issue 11 p. 1120-1125 Bowel dysfunction following hysterectomy S. Radley, S. Radley Senior Lecturer University Department of Surgery, Queen Elizabeth Hospital, Edgbaston, BirminghamSearch for more papers by this authorM. R. B. Keighley, M. R. B. Keighley Professor (Surgery) University Department of Surgery, Queen Elizabeth Hospital, Edgbaston, BirminghamSearch for more papers by this authorS. C. Radley, S. C. Radley Senior Registrar Department of Obstetrics and Gynaecology, Central Shefield Hospitals Trust, ShefieldSearch for more papers by this authorC. H. Mann, C. H. Mann Professor/Specialist Registrar Department of Obstetrics and Gynuecology, Birmingham Women's Hospital, Edgbaston, BirminghamSearch for more papers by this author S. Radley, S. Radley Senior Lecturer University Department of Surgery, Queen Elizabeth Hospital, Edgbaston, BirminghamSearch for more papers by this authorM. R. B. Keighley, M. R. B. Keighley Professor (Surgery) University Department of Surgery, Queen Elizabeth Hospital, Edgbaston, BirminghamSearch for more papers by this authorS. C. Radley, S. C. Radley Senior Registrar Department of Obstetrics and Gynaecology, Central Shefield Hospitals Trust, ShefieldSearch for more papers by this authorC. H. Mann, C. H. Mann Professor/Specialist Registrar Department of Obstetrics and Gynuecology, Birmingham Women's Hospital, Edgbaston, BirminghamSearch for more papers by this author First published: 19 August 2005 https://doi.org/10.1111/j.1471-0528.1999.tb08135.xCitations: 20Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Citing Literature Volume106, Issue11November 1999Pages 1120-1125 RelatedInformation
OBJECTIVE:To analyse the five year cytology follow up data after discharge on women treated for histologically proven cervical intraepithelial neoplasia (CIN) 2 and 3. To assess whether the introduction of the 1992 Guidelines for Clinical Practice and Programme Management affected follow up patterns. To identify who was lost to follow up and for what reasons.DESIGN:A retrospective cohort study of cervical cytological follow up data from 186 women treated for CIN 2 and 3.SETTING:Primary care services, West Midlands, United Kingdom.POPULATION:One hundred and eighty-six women with CIN 2 or 3 treated with large loop excision of the transformation zone at the City Hospital, Birmingham, in whom the first follow up smear at six months was normal. The women were divided into two groups: Group 1 consisted of women treated before the introduction of the Guidelines (1988-1990), and Group 2 consisted of women treated at the time of the introduction of the Guidelines in 1992.INTERVENTION:Introduction of the 1992 Guidelines for Clinical Practice and Programme Management.MAIN OUTCOME MEASURES:To determine the number of follow up smears each woman had over a five year period, to determine the number of women who had the recommended number of follow up smears, and to identify the number of women lost to follow up.RESULTS:The median (interquartile range) number of smears in Group 1 was five (four to six) and in Group 2 was four (four to five). A similar proportion of women in both groups subsequently had abnormal smears (15% and 13.6%). Only one woman required further treatment. 22% of women in Group 1 and 10.2% of women in Group 2 had the correct number of smears to fulfil the 1992 Guidelines. There were 21 women (11.3%) who only had one smear following discharge from the clinic in the five year follow up period.CONCLUSIONS:The data from both cohorts shows follow up to be poor, and the introduction of the 1992 Guidelines has yet to result in an improvement in follow up patterns. The absence of a national cervical cytology database means that surveys of cytology follow up data will continue to be difficult due to the problems of data collection from numerous health authorities and the mobility of women in this age group.
Progressive peripheral neuropathy is an unusual condition in pregnancy requiring specialist opinion to identify the possible underlying pathology. The case presented is that of a patient with cervical intradural lipoma and worsening neurological symptoms, treated surgically at the time of caesarean section. This rare disease and its management are discussed.