Estimated blood loss in pregnant women with cardiac disease compared with low risk women: a restrospective cohort study.

BACKGROUND: Women with cardiac disease are thought to be at increased risk of post-partum haemorrhage. We sought to assess the estimated blood loss (EBL) in our cohort of women with and without cardiac disease (CD) in a quaternary hospital in the UK. Our population consisted of both congenital and acquired CD; and low risk women who delivered in our unit between 01/01/2012-30/09/2016. METHODS: Data were collected using computerised hospital records. CD was classified according to the modified WHO classification (mWHO). The primary outcome measure was estimated blood loss (mL). RESULTS: A total of 5413 women with a singleton fetus in the cephalic presentation delivered during the study period (159 women with CD and 5254 controls). In the CD group, active management of the third stage of labour was consistent with that used in low risk women in 98% (152/155) of cases. Multivariable analyses demonstrated no significant difference in EBL between women with CD vs controls. The adjusted average blood losses were 247.2 ml, 241.8 ml and 295.9 ml in the control group, mWHO 1-2 and 3-4, respectively (p = 0.165). CONCLUSIONS: Women with CD have comparable EBL to low risk women when management of the active third stage of labour is the same.

Pregnancy Outcomes in Women With Transposition of the Great Arteries After an Arterial Switch Operation.

Importance: A growing number of women are approaching childbearing age after arterial switch surgery for transposition of the great arteries. Prepregnancy counseling requires updated knowledge of the additional cardiovascular risks pregnancy poses for this cohort of women and the potential effect on their offspring; however, to our knowledge, this information is currently unknown. Objective: To determine the pregnancy outcomes of women with transposition of the great arteries after an arterial switch operation, as well as the outcomes of their offspring. Design, Setting, and Participants: This cohort study assessed women who had had arterial switch surgery from 1985 to the present and who were 16 years or older as of January 2018. All women with a previous arterial switch surgery for transposition of the great arteries with completed or ongoing pregnancy were included. Data were collected in a level 1 congenital cardiology center and joint obstetrics-cardiology clinic in Birmingham, United Kingdom. Exposures: Patients were assessed before, during, and after pregnancy. Main Outcomes and Measures: Adverse maternal cardiac events (arrhythmia, heart failure, aortic dissection, or acute coronary syndrome) and aortic root dilatation, aortic regurgitation, and left ventricular function before and after pregnancy were the main outcomes. Mode of delivery and fetal outcomes were considered secondary outcomes. Results: A total of 25 pregnancies were identified in 15 women; 8 women had had 1 pregnancy, while 7 were multiparous. There were no adverse maternal cardiac events. Before pregnancy, 8 women (53%) had no aortic regurgitation, 1 (7%) had a trivial degree of regurgitation, 4 (26%) had mild regurgitation, and 2 (14%) had moderate regurgitation. After pregnancies, 1 woman (7%) had minor progression of aortic regurgitation. Five women (36%) had mild neoaortic root dilatation prepregnancy, but none developed progressive dilatation in the first year post-partum. A total of 24 pregnancies were completed by the end of the study, with all infants born alive and well. Nineteen modes of delivery were known; there were 7 cesarean deliveries (37%), of which 2 (11%) were recommended for aortic dilatation and 5 (26%) for obstetric indications or maternal choice. Conclusions and Relevance: Pregnancy is well tolerated after arterial switch operation; no adverse maternal cardiac events or early progression of neoaortic root dilatation or aortic regurgitation were observed in this study. These results provide evidence to allow reassurance of women with previous arterial switch surgery who are planning pregnancies.

Long-term outcome following pregnancy in women with a systemic right ventricle: is the deterioration due to pregnancy or a consequence of time?

INTRODUCTION: The right ventricle (RV) supports the systemic circulation in patients who have had an intraatrial repair of transposition of the great arteries or have congenitally corrected transposition. There is concern about the ability of a systemic RV to support the additional volume load of pregnancy, and previous studies have reported deterioration in RV function following pregnancy. However, conditions with a systemic RV are also associated with progressive RV dysfunction over time. To date, no study has examined whether the deterioration associated with pregnancy is due to the physiological changes of pregnancy itself, or is part of the known deterioration that occurs with time in these patients. METHODS: Women who had undergone pregnancy under the care of the Adult Congenital Heart Disease Unit at the Queen Elizabeth Hospital were retrospectively identified and matched to separate male and nulliparous female controls. Functional status (New York Health Association [NYHA]), RV function, and systemic atrioventricular valve regurgitation were recorded for each group at baseline, postpregnancy (or at 1 year for control groups) and at latest follow-up. RESULTS: Eighteen women had 31 pregnancies (range 1-4) resulting in 32 live births. There were no maternal but one neonatal death. At baseline, there was no significant difference in NYHA class or RV function between pregnancy and control groups. In postpregnancy, there was a significant deterioration in the pregnant group alone for both NYHA class (P = 0.004) and RV function (P = 0.02). At latest follow-up, there was a significant deterioration in RV function in all three groups. There was still a reduction from baseline in NYHA of women who had undergone pregnancy (P = 0.014), which again was not seen in the controls groups. CONCLUSION: This study suggests that pregnancy is associated with a premature deterioration in RV function in women with a systemic RV. These women are also more symptomatic, with a greater reduction in functional class compared with patients with a systemic RV who do not undergo pregnancy. This study will allow this cohort of women to be more accurately counseled as to the potential long-term risks of pregnancy.

The quality of reporting of primary test accuracy studies in obstetrics and gynaecology: application of the STARD criteria.

BACKGROUND: In obstetrics and gynaecology there has been a rapid growth in the development of new tests and primary studies of their accuracy. It is imperative that such studies are reported with transparency allowing the detection of any potential bias that may invalidate the results. The objective of this study was to determine the quality of reporting in diagnostic test accuracy studies in obstetrics and gynaecology using the Standards for Reporting of Diagnostic Accuracy--STARD checklist. METHODS: The included studies of ten systematic reviews were assessed for compliance with each of the reporting criteria. Using appropriate statistical tests we investigated whether there was an improvement in reporting quality since the introduction of the STARD checklist, whether a correlation existed between study sample size, country of origin of study and reporting quality. RESULTS: A total of 300 studies were included (195 for obstetrics, 105 for gynaecology). The overall reporting quality of included studies to the STARD criteria was poor. Obstetric studies reported adequately > 50% of the time for 62.1% (18/29) of the items while gynaecologic studies did the same 51.7% (15/29). There was a greater mean compliance with STARD criteria in the included obstetric studies than the gynaecological (p < 0.0001). There was a positive correlation, in both obstetrics (p < 0.0001) and gynaecology (p = 0.0123), between study sample size and reporting quality. No correlation between geographical area of publication and compliance with the reporting criteria could be demonstrated. CONCLUSIONS: The reporting quality of papers in obstetrics and gynaecology is improving. This may be due to initiatives such as the STARD checklist as well as historical progress in awareness among authors of the need to accurately report studies. There is however considerable scope for further improvement.

Methodological quality of test accuracy studies included in systematic reviews in obstetrics and gynaecology: sources of bias.

BACKGROUND: Obstetrics and gynaecology have seen rapid growth in the development of new tests with research on these tests presented as diagnostic accuracy studies. To avoid errors in judgement it is important that the methodology of these studies is such that bias is minimised. Our objective was to determine the methodological quality of test accuracy studies in obstetrics and gynaecology using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) checklist and to assess sources of bias. METHODS: A prospective protocol was developed to assess the impact of QUADAS on ten systematic reviews performed over the period 2004-2007.We investigated whether there was an improvement in study quality since the introduction of QUADAS, whether a correlation existed between study sample size, country of origin of study and its quality. We also investigated whether there was a correlation between reporting and methodological quality and by the use of meta-regression analyses explored for items of quality that were associated with bias. RESULTS: A total of 300 studies were included. The overall quality of included studies was poor (> 50% compliance with 57.1% of quality items). However, the mean compliance with QUADAS showed an improvement post-publication of QUADAS (54.9% versus 61.4% p = 0.002). There was no correlation with study sample size. Gynaecology studies published from the United States of America showed higher quality (USA versus Western Europe p = 0.002; USA versus Asia p = 0.004). Meta-regression analysis showed that no individual quality item had a significant impact on accuracy. There was an association between reporting and methodological quality (r = 0.51 p < 0.0001 for obstetrics and r = 0.56 p < 0.0001 for gynaecology). CONCLUSIONS: A combination of poor methodological quality and poor reporting affects the inferences that can be drawn from test accuracy studies. Further compliance with quality checklists is required to ensure that bias is minimised.

Systematic review and meta-analysis of the test accuracy of ductus venosus Doppler to predict compromise of fetal/neonatal wellbeing in high risk pregnancies with placental insufficiency.

OBJECTIVE: To evaluate the test accuracy of ductus venosus Doppler for prediction of compromise of fetal/neonatal wellbeing. STUDY DESIGN: The search strategy employed searching of electronic databases (Medline, Embase, Cochrane library, Medion) from inception to May 2009, hand searching of journal and reference lists, contact with experts. Two reviewers independently selected articles in which the results of ductus venosus Doppler were associated with the occurrence of compromise of fetal/neonatal wellbeing. There were no language restrictions applied. Data were extracted on study characteristics, quality and results to construct 2 x 2 tables. Likelihood ratios for positive and negative test results, sensitivity, specificity and their 95% confidence intervals were generated for the different indices and thresholds. RESULTS: Eighteen studies, testing 2267 fetuses met the selection criteria, all performed in a high risk population with placental insufficiency in second/third trimester. Meta-analysis showed moderate predictive accuracy. The best result was for the prediction of perinatal mortality, positive likelihood ratio 4.21 (95% CI 1.98-8.96) and negative likelihood ratio 0.43 (95% CI 0.30-0.61). For prediction of adverse perinatal outcome the results were positive likelihood ratio 3.15 (95% CI 2.19-4.54) and negative likelihood ratio 0.49 (95% CI 0.40-0.59). CONCLUSION: Abnormal ductus venosus Doppler showed moderate predictive accuracy for compromise of fetal/neonatal wellbeing overall and perinatal mortality in high risk pregnancies with placental insufficiency.

Laparoscopic uterosacral nerve ablation for alleviating chronic pelvic pain: a randomized controlled trial.

CONTEXT: Chronic pelvic pain is a common condition with a major effect on health-related quality of life, work productivity, and health care use. Operative interruption of nerve trunks in the uterosacral ligaments by laparoscopic uterosacral nerve ablation (LUNA) is a treatment option for patients with chronic pelvic pain. OBJECTIVE: To assess the effectiveness of LUNA in patients with chronic pelvic pain. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of 487 women with chronic pelvic pain lasting longer than 6 months without or with minimal endometriosis, adhesions, or pelvic inflammatory disease, who were recruited to the study by consultant gynecological surgeons from 18 UK hospitals between February 1998 and December 2005. Follow-up was conducted by questionnaires mailed at 3 and 6 months and at 1, 2, 3, and 5 years. INTERVENTION: Bilateral LUNA or laparoscopy without pelvic denervation (no LUNA); participants were blinded to the treatment allocation. MAIN OUTCOME MEASURES: The primary outcome was pain, which was assessed by a visual analogue scale. Data concerning the 3 types of pain (noncyclical pain, dysmenorrhea, and dyspareunia) were analyzed separately as was the worst pain level experienced from any of these 3 types of pain. The secondary outcome was health-related quality of life, which was measured using a generic instrument (EuroQoL EQ-5D and EQ-VAS). RESULTS: After a median follow-up of 69 months, there were no significant differences reported on the visual analogue pain scales for the worst pain (mean difference between the LUNA group and the no LUNA group, -0.04 cm [95% confidence interval {CI}, -0.33 to 0.25 cm]; P = .80), noncyclical pain (-0.11 cm [95% CI, -0.50 to 0.29 cm]; P = .60), dysmenorrhea (-0.09 cm [95% CI, -0.49 to 0.30 cm]; P = .60), or dyspareunia (0.18 cm [95% CI, -0.22 to 0.62 cm]; P = .40). No differences were observed between the LUNA group and the no LUNA group for quality of life. CONCLUSION: Among women with chronic pelvic pain, LUNA did not result in improvements in pain, dysmenorrhea, dyspareunia, or quality of life compared with laparoscopy without pelvic denervation. TRIAL REGISTRATION: controlled-trials.com Identifier: ISRCTN41196151.

A systematic review of tests for lymph node status in primary endometrial cancer.

BACKGROUND: The lymph node status of a patient is a key determinate in staging, prognosis and adjuvant treatment of endometrial cancer. Despite this, the potential additional morbidity associated with lymphadenectomy makes its role controversial. This study systematically reviews the accuracy literature on sentinel node biopsy; ultra sound scanning, magnetic resonance imaging (MRI) and computer tomography (CT) for determining lymph node status in endometrial cancer. METHODS: Relevant articles were identified form MEDLINE (1966-2006), EMBASE (1980-2006), MEDION, the Cochrane library, hand searching of reference lists from primary articles and reviews, conference abstracts and contact with experts in the field. The review included 18 relevant primary studies (693 women). Data was extracted for study characteristics and quality. Bivariate random-effect model meta-analysis was used to estimate diagnostic accuracy of the various index tests. RESULTS: MRI (pooled positive LR 26.7, 95% CI 10.6 - 67.6 and negative LR 0.29 95% CI 0.17 - 0.49) and successful sentinel node biopsy (pooled positive LR 18.9 95% CI 6.7 - 53.2 and negative LR 0.22, 95% CI 0.1 - 0.48) were the most accurate tests. CT was not as accurate a test (pooled positive LR 3.8, 95% CI 2.0 - 7.3 and negative LR of 0.62, 95% CI 0.45 - 0.86. There was only one study that reported the use of ultrasound scanning. CONCLUSION: MRI and sentinel node biopsy have shown similar diagnostic accuracy in confirming lymph node status among women with primary endometrial cancer than CT scanning, although the comparisons made are indirect and hence subject to bias. MRI should be used in preference, in light of the ASTEC trial, because of its non invasive nature.

Diagnostic accuracy of tests for lymph node status in primary cervical cancer: a systematic review and meta-analysis.

BACKGROUND: Lymph node status is the key to determining the prognosis and treatment of cervical cancer. However, it cannot be assessed clinically, and testing for nodal metastasis is controversial. We sought to systematically review the diagnostic accuracy literature on sentinel node biopsy, positron emission tomography, magnetic resonance imaging and computed tomography to evaluate the accuracy of each index test in determining lymph node status in patients with cervical cancer. METHODS: We searched MEDLINE (1966-2006), EMBASE (1980-2006), Medion (1980-2006) and the Cochrane library (Issue 2, 2006) for relevant articles. We also manually searched the reference lists from primary articles and reviews, and we contacted experts in the field for conference abstracts and unpublished studies. We performed random-effects meta-analysis of accuracy indices, and we performed meta-regression analysis to test the effect of study quality on diagnostic accuracy and to identify other sources of heterogeneity. RESULTS: We included 72 relevant primary studies, involving a total of 5042 women, in our analysis. We found that, in determining lymph node status, sentinel node biopsy had a pooled positive likelihood ratio of 40.8 (95% confidence interval [CI] 24.6-67.6) and a pooled negative likelihood ratio of 0.18 (95% CI 0.14-0.24). The pooled positive likelihood ratios (and 95% CI) were 15.3 (7.9-29.6) for positron emission tomography, 6.4 (4.9-8.3) for magnetic resonance imaging and 4.3 (3.0-6.2) for computed tomography. The pooled negative likelihood ratios (and 95% CIs) were 0.27 (0.11-0.66) for positron emission tomography, 0.50 (0.39-0.64) for magnetic resonance imaging and 0.58 (0.48-0.70) for computed tomography. Using a 27% pretest probability of lymph node metastasis among all cases (regardless of stage), we found that a positive sentinel node biopsy result increased post-test probability to 94% (95% CI 90%-96%), whereas a positive finding on positron emission tomography increased it to 85% (75%-92%). INTERPRETATION: Sentinel node biopsy has greater accuracy in determining lymph node status among women with primary cervical cancer than current commonly used imaging methods.

Quality of information accompanying on-line marketing of home diagnostic tests.

OBJECTIVE: To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. DESIGN: A cross-sectional analysis of a database developed from searching targeted websites. SETTING: Data sources were websites written in English which marketed medical home diagnostic tests. MAIN OUTCOME MEASURES: A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. RESULTS: 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. CONCLUSIONS: The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers.

Gynaecologic surgery from uncertainty to science: evolution of randomized control trials.

BACKGROUND: It is now accepted that both medical and surgical practice should be based on reliable and sound clinical evidence. However, randomized control trials comparing surgical interventions have been associated with many problems. The aim of this review is to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology. METHODS: Relevant reviews were identified from Cochrane Database of Systematic Reviews (Issue , 2006) and data from individual randomized control trials extracted. Chi-squared test was used to compare quality pre- and post-Consolidated Standards of Reporting Trials (CONSORT) statement. Meta-regression analyses were performed to test the hypothesis that effect size decreased over time. Further multiple linear regression analyses were used to test the hypothesis that precision increased over time and finally a logistic regression model was used to estimate whether treatment effects differed between trials with and without allocation concealment. RESULTS: Twenty-three relevant reviews were identified, including 94 trials. The proportion of studies reporting allocation concealment significantly increased after the introduction of the CONSORT statement (P = 0.002). There was a trend towards improvement in precision over time. Similarly, there was a reduction in size of treatment effect over time (log of the ratio of odds ratios per year 0.96; 95% confidence interval 0.93-0.99, P = 0.04). CONCLUSIONS: Gynaecologic surgical practice appears to be benefiting from improvement in its research base in a subject where practitioners do not participate readily in randomized evaluation.

Quality of health information for cervical cancer treatment on the internet.

BACKGROUND: The internet has become a frequently used and powerful tool for patients seeking medical information. This information may not undergo the same quality consideration as the peer-review criteria for publication of information in a journal. The aim of this study is to assess the quality of internet sites providing information on the treatment of cervical cancer, with comparisons between the quality assessments made by an educated lay person and an expert in the field. METHODS: A search of the World Wide Web was made by a lay person to identify sites containing information on the treatment of cervical cancer. The credibility and accuracy of these sites was assessed using predefined criteria based on 'Criteria for Assessing the Quality of Health Information on the Internet' and accepted guidelines for the treatment of cervical cancer. The assessment was made independently and in duplicate by the lay reviewer and medical expert in order to allow comparison. RESULTS: 46 relevant websites were assessed. Only one site contained all the credibility and accuracy criteria, with a further website containing all the credibility criteria. The majority of sites, 38/46, were deemed easy to navigate. The agreement between lay person and expert was good with only 6 items in total changed by the expert. CONCLUSION: This study clearly shows there is wide variation in quality of websites available to patients on the treatment of cervical cancer. Further research and consideration is needed on the effects of website information on gynaecological cancer patients and how steps can be made to insure the posting of good quality information.