Educational effectiveness of gynaecological teaching associates: a multi-centre randomised controlled trial.

OBJECTIVE: To evaluate, among medical students learning the female pelvic examination, the added benefits of training by gynaecological teaching associates compared with training involving a manikin only. DESIGN: Randomised controlled trial. SETTING: Nine university teaching hospitals. POPULATION: Ninety-four medical students recruited prior to commencing a 4-week obstetrics and gynaecology rotation. METHODS: The control training consisted of lectures, demonstration of the pelvic examination on a manikin, and opportunities to practise on this low-fidelity simulation (n = 40). The experimental group received additional gynaecological teaching associate training, delivered by pairs of experienced associates to groups of four medical students (n = 54). MAIN OUTCOME MEASURES: Outcomes measured at the end of the rotation included knowledge of the correct order of examination components (Yes/No), and student comfort [Likert scales anchored between 1 (very uncomfortable) and 4 (very comfortable) on four items] and confidence [Likert scales anchored between 1 (No) and 3 (Yes) on six items]. The primary outcome, measured at the end of the academic year, was the objective structured clinical examination of a female pelvis (score range 0-54). RESULTS: At baseline, the groups were similar in age, gender, and ethnicity. At the end of the clinical rotation, when compared with the control intervention, the experimental intervention had a moderate effect on student knowledge [difference 29.9% (95% CI 11.2-48.6%); P = 0.002] and confidence [difference 1 (95% CI 0-2); P < 0.001], and a large effect on student comfort [difference 1.8 (95% CI 0.6-3.0); P = 0.004]. At the end of the academic year, the experimental intervention had no impact on skills compared with the control [difference 2 (95% CI-1 to 4); P = 0.26]. CONCLUSIONS: Among medical students taught the female pelvic examination by low-fidelity simulation, additional training by gynaecology teaching associates improved knowledge, comfort, and confidence at the end of the clinical rotation but did not improve examination skills at end of the academic year.

Cervical cytologic abnormalities and negative colposcopy: histologic assessment.

Colposcopic assessment may be normal in the presence of severe or persistent minor cytologic abnormality. To assess the significance of negative satisfactory colposcopy in patients with abnormal cervical smears, a retrospective review was carried out on 1170 patients who had undergone out-patient loop diathermy excision for abnormal cervical cytology. Of these, 69 patients were treated for abnormal cervical cytology, despite normal colposcopic findings. Cytologic abnormalities ranged from persistent borderline changes to severe dyskariosis. Histologic assessment of the excision specimens revealed cervical intraepithalial neoplasia (CIN) in 43 (62.3%) cases, of which high-grade CIN accounted for 24 (34.8%) cases. There was good correlation between cytologic and histologic diagnosis. Simple regression analysis showed r = 0.46, P < 0.0001. The cytologic abnormality was highly predictive of the corresponding histologic diagnosis. This analysis has shown that significant intraepithelial lesions may exist despite negative colposcopic examination and highlights the need for histologic evaluation in such cases. In these circumstances, loop cone biopsy permits accurate definition of lesion severity, avoids potential undertreatment of significant lesions and causes less morbidity than conventional cone biopsy.

Effect of oral gamolenic acid from evening primrose oil on menopausal flushing.

OBJECTIVE: To evaluate the efficacy of gamolenic acid provided by evening primrose oil in treating hot flushes and sweating associated with the menopause. DESIGN: Randomised, double blind, placebo controlled study. SETTING: District general hospital and teaching hospital. SUBJECTS: 56 menopausal women suffering hot flushes at least three times a day. INTERVENTION: Four capsules twice a day of 500 mg evening primrose oil with 10 mg natural vitamin E or 500 mg liquid paraffin for six months. MAIN OUTCOME MEASURES: Change in the number of hot flushes or sweating episodes a month. RESULTS: 56 diaries were analysed, 28 from women taking gamolenic acid and 28 from those taking placebo. Only 18 women given gamolenic acid and 17 given placebo completed the trial. The mean (SE) improvement in the number of flushes in the last available treatment cycle compared with the control cycle was 1.9 (0.4) (P < 0.001) for daytime flushes and 0.7 (0.3) (P < 0.05) for night time flushes in women taking placebo; the corresponding values for women taking gamolenic acid were 0.5 (0.4) and 0.5 (0.3). In women taking gamolenic acid the only significant improvement was a reduction in the maximum number of night time flushes (1.4 (0.6); P < 0.05). CONCLUSION: Gamolenic acid offers no benefit over placebo in treating menopausal flushing.

A randomized prospective study comparing delivery with metal and silicone rubber vacuum extractor cups.

OBJECTIVE: To determine the relative benefits and complications of assisted vaginal delivery with metal and silicone rubber vacuum extractor cups. DESIGN: Prospective randomized controlled study. SETTING: A busy referral maternity hospital in Kathmandu, Nepal. SUBJECTS: 101 women were assigned to delivery with the Silc-cup and 98 to delivery with the metal cup. MAIN OUTCOME MEASURES: Success rate at achieving delivery with the assigned instrument and incidence of neonatal trauma. Analysis was by 'intention to deliver' with women remaining in their original group regardless of the eventual mode of delivery. RESULTS: Randomization resulted in two groups of women similar in respect of age, parity, gestation and indication for delivery. The overall success rate was similar for the two instruments (Silc-cup 85% and metal cup 87%). The Silc-cup was more likely to fail if there was excessive caput (seven failures compared with one in the metal cup group). The frequency of clinically significant maternal trauma was low in both groups. There were fewer babies with clinically significant scalp trauma in the Silc-cup group (22%), compared with the metal cup group (37%). CONCLUSIONS: The data indicate a greater tendency for the Silc-cup to fail when excessive caput is present but that metal cups are associated with increased scalp injuries.

A multicentre study of perinatal mortality in Nepal.

A prospective survey was carried out in two Kathmandu hospitals and two rural districts to establish urban and rural perinatal mortality rates (PNMRs) for these four centres in Nepal and to ascertain the causes of perinatal mortality. All perinatal deaths occurring over a 1-year period in the four centres were included (during which time there was a total of 14,967 births). Cause of death was established by contemporary review of hospital case records or by structured questionnaire ('verbal autopsy') in the rural areas. The PNMRs in the hospitals were 48.0 and 23.7 per thousand total births respectively, whilst those of the rural settings were 96.2 and 42.5 per thousand births. Perinatal asphyxia, low birthweight and infection were the most common causes but many of the deaths were unexplained. The high mortality rates were felt to reflect the difficult circumstances of childbirth in Nepal. It was concluded that a number of interventions would appear appropriate, but that these should be introduced in a scientific manner.

PIP: A prospective survey was carried out in 2 Kathmandu hospitals and 2 rural districts to establish urban and rural perinatal mortality rates (PNMRs) and to ascertain the causes of perinatal mortality. The sites chosen for community-based studies were in Lalitpur district in the Kathmandu valley and Jumla in the remote north-west of Nepal as the second site. All perinatal deaths occurring over a 1-year period in the 4 centers were included. Cause of death was established by contemporary review of hospital case records or by structured questionnaire in the rural areas. The previous pregnancy was a live birth in 82% of cases at the Maternity Hospital, in 76% at Patan Hospital, in 87% in Jumla, and in 79% of cases from Lalitpur. On the other hand the overall poor outcome from previous pregnancies appeared to correlate with the present perinatal mortality rates. The PNMRs in the hospitals were 48.0 and 23.7 per 1000 total births, respectively, while those of the rural settings were 96.2/1000 and 42.5/1000 births. Perinatal asphyxia, low birth weight, and infection were the most common causes, but many of the deaths were unexplained. 32% of women at the Maternity Hospital had a previous pregnancy loss compared with 29% at Patan Hospital, 24% at Lalitpur and at Jumla. At Patan Hospital nearly 90% of patients had attended an antenatal clinic. Conversely, at the Maternity Hospital only 40% of women with a perinatal loss had received antenatal care; and in Jumla and Lalitpur less than 20% of women had. In Jumla 79% of the perinatal deaths were preterm and in Lalitpur 50%. At Patan Hospital, the PNMR in this weight category was 769.2/1000 and at Maternity Hospital 876.6/1000 total births. PNMRs were higher for male infants in the Maternity Hospital (51.7/1000 vs. 43/1000), in Patan Hospital (32/1000 vs. 15/1000), and in Jumla (108/1000 vs. 81/1000). Recognized risk factors for perinatal mortality were confirmed, such as increasing parity, increasing age, and being male.

Enthusiasm and teamwork--the basis for increase in laparoscopic surgery for ectopic pregnancy: an Inner London district hospital experience.

Laparoscopic surgery is the gold standard in the surgical management of ectopic pregnancy. It results in lower morbidity, less impact on reproductive health and faster return to normal activity. However, laparoscopic management is not available to all women. Between April 2001 and March 2002 a prospective audit of surgical management of ectopic pregnancy was carried out; 88.7% were performed laparoscopically, most due to concerted consultant input to the care of women with ectopic pregnancy.

Cigarette smoking and histological outcome in women with mildly dyskaryotic cervical smears.

OBJECTIVE: To determine which patient related variables, available at the point of referral, predict the presence of high grade intraepithelial neoplasia when the smear result is mild dyskaryosis with or without co-existent koilocytosis. DESIGN: Multivariate analysis of prospective programme trial. SETTING: Academic Department Colposcopy clinics at Dudley Road Hospital, Birmingham, UK. SUBJECTS: One hundred and sixty-seven women, whose worst ever cervical smear was mild dyskaryosis with or without koilocytosis, referred to colposcopy clinics. All the women had complete data sets, as determined by the format of an ongoing programme, and all were treated by diathermy loop excision of the cervical transformation zone. MAIN OUTCOME MEASURES: Age, parity, contraceptive practice, smoking habit, duration of abnormal cytology and the grade of histology in the excised transformation zone. RESULTS: Forty-seven out of 78 (60%) smokers, compared with 18 out of 73 (25%) nonsmokers, had high grade disease. The other variables considered in the analysis were not significant or very weakly associated with histological grade when analysed in a univariate analysis. Stepwise logistic regression identified cigarette smoking as a powerful independent predictor of high grade disease. CONCLUSION: These data suggest a strong association between smoking and high grade intraepithelial neoplasia in a population of women whose worst ever smear report was mild dyskaryosis. Smoking is a variable that could be built into models to facilitate referral for colposcopic assessment.

The effect of directed biopsy on the atypical cervical transformation zone: assessed by digital imaging colposcopy.

OBJECTIVE: To determine the effect of directed punch biopsy trauma on the natural history of atypical cervical transformation zones. DESIGN: A prospective randomised clinical trial. SETTING: Academic Unit colposcopy clinics in Birmingham. PARTICIPANTS: One hundred and eighty women attending the colposcopy clinics were recruited over an 18 month period, of which 161 were eligible for analysis. METHODS: Three-way randomisation of patients into 1. no biopsy, 2. central biopsy and 3. peripheral biopsy groups. Quantitative assessment of the change in surface area and severity of cervical intra-epithelial neoplasia (CIN) lesions in each group measured six weeks apart using digital imaging colposcopy. RESULTS: No significant difference in change in lesion size (P = 0.40) was noted in the three treatment groups. Results suggest that the severity of the lesion was underestimated by the peripheral biopsy. CONCLUSIONS: The results of this study suggest that directed punch biopsy trauma does not have a significant effect on the immediate natural history of CIN. No statistically significant differences were found in lesion size whether biopsy was employed or not. In addition, the site of biopsy had no influence on the outcome. It appears, therefore, that tissue trauma from punch biopsy and the subsequent inflammatory and wound healing processes do not modify the course of CIN. The regressive changes observed after punch biopsy in previous natural history studies are probably not a result of the initial inflammatory response to biopsy trauma and subsequent re-epithelialisation with normal cells, but may result from processes that continue long after tissue repair is completed.

Digital imaging colposcopy, image analysis and quantification of the colposcopic image.

OBJECTIVE: To investigate the use of a digital imaging system for colposcopy, its use for image analysis and quantification of the colposcopic features that may predict histological outcome as defined by large loop excision of transformation zone. DESIGN: Prospective programme study of all patients undergoing colposcopy for cytological abnormalities. SETTING: Dudley Road Hospital, Birmingham. SUBJECTS: Fifty consecutive patients having cytological and colposcopic abnormality treated with large loop excision of transformation zone formed the study group. MAIN OUTCOME MEASURES: Pretreatment and colposcopic features correlated with histological diagnosis of excised transformation zone. RESULTS: Index cytology and current smoking status are the most important variables for prediction of histological diagnosis. Other important variables are focality of lesion, surface pattern, intercapillary distance and degree of acetowhiteness. CONCLUSION: Digital imaging colposcopy allows image capture, processing and objective analysis. This methodology holds advantages for basic and clinical research, teaching, diagnostics and clinical audit. The system can act as a quality control tool for colposcopy units. This system should prove invaluable for further quantitative studies, for natural history studies and for those patients with deferred treatment of their cytological and colposcopic abnormalities. The statistical models described may be incorporated into the system and can aid the colposcopist in management of the woman with abnormal cervical cytology and colposcopic abnormality.

Vulvoperineal reconstruction after excision of anogenital multifocal intraepithelial neoplasia ("MIN").

Over the past 7 years, 12 women have been treated utilising a radical surgical approach for extensive vulval involvement as a component of multifocal intraepithelial neoplasia (MIN) of the female genital tract. The patients were analysed with respect to the anatomical site of involvement, age, presenting complaints and their duration, colposcopic examination, histopathology and surgical treatment. Gynaecologists, general surgeons and plastic surgeons were involved in the surgical treatment which was an initial colostomy followed by a definitive vulvoperineal resection and simultaneous vulval reconstruction using meshed split skin grafts or a combination of skin grafts and local flaps. 17 vulvoperineal reconstructions were done for 12 patients. Three had an incomplete histopathological clearance at the initial operation. Apart from these three patients, one had recurrence of symptoms alone, without any evidence of MIN, which was possibly due to human papilloma virus infection. One patient developed malignant squamous invasion 4 years later, which was cured with surgical excision and reconstruction. Colostomy closure was done after achieving local control of the disease. This staged approach does achieve the objectives of eliminating disease and alleviating symptoms. It preserves function and attempts to reconstruct normal anatomy without compromising the principles of surgical oncology and results in a high patient satisfaction.

Fallopian tube ciliary beat frequency in relation to the stage of menstrual cycle and anatomical site.

BACKGROUND: The cyclical changes in ciliary structure and motion within the human Fallopian tube are well documented. Previous investigators have studied ciliary beat frequency (CBF) in relation to menstrual cycle and anatomical site, but with conflicting results. METHODS: Using a technique that records variations in light intensity, we have studied the changes in CBF in relation to the menstrual cycle and anatomical site. Fallopian tubes were collected from 26 women who underwent hysterectomy for benign conditions. Menstrual history, hormone profile and endometrial biopsy results were used to determine the stage of the cycle. Fourteen women were in the proliferative phase, and 12 women in the secretory phase. RESULTS: Mean CBF for all subjects was 5.3 plus minus 0.2 Hz. There was no significant difference in CBF in relation to anatomical site. In the fimbrial region the ciliary beat was faster in the secretory (5.8 plus minus 0.3 Hz) as compared with the proliferative phase (4.9 plus minus 0.2 Hz), P < 0.02. CONCLUSIONS: It is possible that this increase in fimbrial CBF may contribute to ovum retrieval and transport after ovulation. However, the reproductive significance of the changes in CBF in relation to the menstrual cycle needs further investigation.

Is the provision of information leaflets before colposcopy beneficial? A prospective randomised study.

OBJECTIVE: To assess the usefulness of a leaflet distributed to women before colposcopy designed to reduce their anxiety and psychosexual morbidity by providing information. DESIGN: Prospective randomised study. SETTING: Colposcopy clinic of a large district general hospital. SAMPLE: Two hundred consecutive women undergoing colposcopy for the first time for a cervical cytological abnormality of severity no greater than moderate dyskaryosis. METHODS: Women were randomised into one of two groups (leaflet or control). Those in the leaflet group were sent an information leaflet prior to attending the clinic. In the colposcopy clinic all the women completed a State/Trait Anxiety Inventory (StAI/TrAI) and a modified psychosexual questionnaire before undergoing colposcopy. This was repeated at the six-month follow up visit. Women in the leaflet group also completed a further questionnaire on the leaflet. MAIN OUTCOME MEASURES: Differences of anxiety and psychosexual scores between leaflet and control groups. RESULTS: The leaflet was well received. There were no statistical differences in StAI and TrAI scores between the study group and the control group at either visit, although in the whole study population StAI and TrAI scores were reduced at the second visit. The leaflet group had significantly more psychosexual problems but by the second visit, the scores had improved and the two groups were similar. When the mean differences in anxiety and psychosexual scores at the initial and second visits were compared between the groups, the reduction in negative sexual feelings and deterioration of TrAI scores experienced by the leaflet group was significant. CONCLUSIONS: This study suggests that the provision of sending an information leaflet prior to colposcopy is not beneficial in isolation. Other approaches need to be considered.