A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues

Cholestasis and Pregnancy

Obstetric cholestasis is an intrahepatic multifactorial disease, unique to pregnancy which presents with intense pruritis and abnormal liver function tests (LFTs). It commonly presents in the third trimester and becomes more severe with advanced gestation. The prevalence of obstetric cholestasis is influenced by genetic and environmental aspects and varies in different populations. The pathogenesis appears to relate to a predisposition to the cholestatic effect of increased circulating oestrogens and progestogens. Also genetic mutations have been reported in a sub-group of women with elevated γ-GT. There can be significant maternal morbidity due to intense pruritis and consequent sleep deprivation. There may be malabsorption with steatorrhea resulting in vitamin K deficiency, prolongation of clotting times and increased risk of postpartum haemorrhage (PPH). Caesarian section rate is much higher for women with obstetric cholestasis. The potential fetal risks include preterm labour and prematurity and unexplained intrauterine death. The aim of the management of obstetric cholestasis is to avoid fetal complications and to relieve maternal symptoms. A variety of drug therapies have been used to reduce maternal pruritis. Policies of active management and induction of labor before 38 weeks may improve pregnancy outcome. Obstetric cholestasis is a diagnosis of exclusion, and other causes of pruritis should be excluded

The challenge of improving IVF results in normogonadotrophic (unexpected) young poor ovarian responders: the predictive value of a flexible treatment protocol based on the “biophysical profile of the uterus”

Objective: To study whether the unexpected poor ovarian responders optimization of uterine receptivity with a flexible controlled ovarian hyper stimulation protocol based on the Biophysical Profile of the Uterus, has an impact on their reproductive performance. Design: Observational Prospective study. Setting(s): i) General hospital-IVF and Infertility Centre; ii) University hospital. Patient(s): 44 normogonadotrophic young women (26 - 38 yrs) with previous “unexpected” poor ovarian response underwent IVF/ICSI treatment on a protocol based on the Biophysical Profile of their uterus (Group A). The same patients were used as controls in a preceded IVF cycle on the conventional stimulation protocol. Intervention(s): None. Main outcome measure(s): Pregnancy, miscarriage and home take baby rates, amount and duration of gonadotropins required, number and quality of embryos resulted, Biophysical Profile of the Uterus score. Result(s). Treatment in Group A in comparison to Group B resulted in significantly larger number of eggs retrieved per patient, and improved fertilization rates and higher number of embryos/ET (p = 0.011, 0.010 and 0.034 respectively). Group A also demonstrated a trend for higher rates of clinical pregnancy (29.5% v.s. 15.9%), viable stage pregnancies ≥ 24 weeks (33.3% v.s. 20%) and home take babies (26.6% v.s. 16%). The amount of gonadotropins used per patient (IU) was similar in the two groups (p = 0.264). Cancellation, implantation and miscarriage rates as well as embryos quality, although superior in the treatment Group A, showed no significant difference. The number of pregnancies achieved in Group A, were directly related with the score in the Biophysical Profile of the Uterus 12 point scale. Conclusion(s): Unexpected Poor Ovarian Responders on the flexible IVF/ICSI protocol (Group A), adjusting the management according to the Biophysical Profile of their uterus (duration of stimulation, day of HCG and day of embryo transfer), had a significantly better performance in comparison to the Group B managed on the conventional protocol in this difficult to manage and so far, rather understudied population

Minimally invasive techniques for female stress urinary incontinence, how, why, when

Aim: The main purpose of this paper is to summarize the recent experience that has been obtained till now in the surgical treatment of urinary stress incontinence with less invasive techniques. Materials and methods: We used current literature and papers published in MEDLINE and Cochrane library. The keywords used for this review were Stress urinary incontinence, Tension-free vaginal tape (TVT), Transobturator tape (TOT, TVT-O), and Single-incision mini-slings (SIMS). Results: Tension-free vaginal tape and the transobturator urethral suspension are the most commonly used surgical approach for women who suffer from stress urinary incontinence, with long-term success rates ranging from 84 to 95 %. TVT is shown to be as effective as the older colposuspension, associated with less post-operative complications, shorter hospital stay and shorter recovery period. Bladder perforations that have been mentioned with the TVT inserter apparently do not result in any clinically significant morbidity. Major vascular and bowel injuries have been reported at rates of 0.07 and 0.04 %, respectively. Studies between TVT-O and TOT show equal effectiveness with slightly lower cure rates than TVT group, but TOT had a significant lower risk of bladder and vaginal perforations. There were no significant differences in objective cure rates between 'inside-out' and 'outside-in' transobturator tapes. Very recently a meta-analysis does not support routine use of SIMS in clinical practice, moreover suggested the retropubic TVT as the preferred choice for the management of stress urinary incontinence due to familiarity, its effectiveness, minimal invasiveness and low complication and morbidity rates as a primary procedure. Similar results have been announced in a randomized control trial in USA. Conclusions: Certainly, larger randomized clinical trials with longer follow-up about the mentioned techniques are needed to accurately determine the efficacy and safety of the mentioned minimally invasive techniques. © 2013 Springer-Verlag Berlin Heidelberg

Indications of diagnostic hysteroscopy, a brief review of the literature

Plenty of authors propose outpatient hysteroscopy as the gold standard diagnostic method for the evaluation of endometrial pathology. This statement has been strengthened in the recent years due to the wide use of smaller diameter hysteroscopic devices, which have made the dilation of the cervix and the use of anesthesia unnecessary. The main purpose of this paper is to summarize the indications of diagnostic hysteroscopy. In this review, we used the most recent publications in MEDLINE and Cochrane Library in order to specify the indications of diagnostic hysteroscopy and the experience that have been obtained till today in the management of certain pathological uterine conditions. The key words we used were diagnostic hysteroscopy, abnormal uterine bleeding, infertility, endometrial cancer. Hysteroscopy provides an accurate method of evaluation and direct visualization of the endometrial cavity and moreover directed biopsy and sampling of suspected lesions. Last years with the continuous development in the hysteroscopy devices, plenty of women benefit surgical hysteroscopy techniques for uterine abnormalities. Hysteroscopy is useful for the diagnosis in patients with abnormal uterine bleeding, with endometrial cancer and in infertile women. Hysteroscopy has the unique advantage of combining a thorough procedure with great diagnostic accuracy. The only disadvantage is that hysteroscopy requires specific teaching and training and has a long learning curve