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Natalie A M Cooper, clinical research fellow Khalid S Khan, professor of obstetrics and gynaecology and clinical epidemiology, honorary consultant obstetrician and gynaecologist T Justin Clark, consultant obstetrician and gynaecologist and honorary senior lecturer ABSTRACT Objective To compare the effects of different types of local anaesthetic for pain control during outpatient hysteroscopy. Design Systematic review and meta-analysis of randomised controlled trials. Setting Outpatient hysteroscopy clinics. Participants Women undergoing diagnostic or operative hysteroscopy as outpatients-that is, without general anaesthesia. Study selection criteria Medline, Embase, CINAHL, the Cochrane library, and reference lists of relevant studies. Two reviewers independently selected trials. Data were abstracted on quality, characteristics, and results. Results There were 20 trials (2851 participants). Data from 15 of these were meta-analysed in subgroups defined by type of intervention and study quality. Intracervical (standardised mean difference −0.36, 95% confidence interval −0.61 to −0.10, I 2 =0%) and paracervical (−1.28, −2.22 to −0.35, I 2 =97%) injections of local anaesthetic significantly reduced the pain in women undergoing hysteroscopy as outpatients, whereas transcervical (−0.11, −0.31 to 0.10, I 2 =27%) and topical application (−0.32, −0.97 to 0.33, I 2 = 90%) did not. Meta-regression showed that paracervical injection was superior to the other anaesthetic methods (P=0.04), a finding that was supported by the high quality subgroup of studies. Use of local anaesthetic did not have a significant effect on the incidence of vasovagal episodes (P=0.09). Conclusions Paracervical local anaesthetic injection is the best method of pain control for women undergoing hysteroscopy as outpatients.

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Background Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients.Objectives To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health.Search strategy Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015.Selection criteria We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort.Data collection and analysis Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression.Main results There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with nonparticipants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I 2 = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88).Conclusions Women participating in RCTs on average experienced better outcomes compared with those outside trials.Keywords Neonate, randomised, systematic review, trial participation, women's health.Tweetable abstract Participants in obstetric and gynaecology RCTs experience better outcomes compared with nonparticipants.Please cite this paper as: Nijjar SK, D'Amico MI, Wimalaweera NA, Cooper NAM, Zamora J, Khan KS. Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

ObjeCtive To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy. DesignPragmatic multicentre randomised controlled noninferiority study.setting Outpatient hysteroscopy clinics in 31 UK National Health Service hospitals.PartiCiPants 507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps.interventiOns Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia. Data were collected on women's self reported bleeding symptoms at baseline and at 6, 12, and 24 months. Data were also collected on pain and acceptability of the procedure at the time of polypectomy. Main OutCOMe MeasuresThe primary outcome was successful treatment, determined by the women's assessment of bleeding at six months, with a prespecified non-inferiority margin of 25%. Secondary outcomes included generic (EQ-5D) and disease specific (menorrhagia multi-attribute scale) quality of life, and feasibility and acceptability of the procedure. results 73% (166/228) of women in the outpatient group and 80% (168/211) in the inpatient group reported successful treatment at six months (intention to treat relative risk 0.91, 95% confidence interval 0.82 to 1.02; per protocol relative risk 0.92, 0.82 to 1.02). Failure to remove polyps was higher (19% v 7%; relative risk 2.5, 1.5 to 4.1) and acceptability of the procedure was lower (83% v 92%; 0.90, 0.84 to 0.97) in the outpatient group Quality of life did not differ significantly between the groups. Four uterine perforations, one of which necessitated bowel resection, all occurred in the inpatient group. COnClusiOnsOutpatient polypectomy was non-inferior to inpatient polypectomy. Failure to remove a uterine polyp was, however, more likely with outpatient polypectomy and acceptability of the procedure was slightly lower. trial registratiOnInternational Clinical Trials Registry 65868569.

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Background Vaginoscopy, also known as the 'no-touch' technique, is an alternative method for performing hysteroscopy without the need for a vaginal speculum to view the cervix or cervical instrumentation to grasp and steady the cervix.Objective To examine the effect of a vaginoscopic approach to outpatient hysteroscopy on the patients' experience of pain, compared with a traditional approach using a vaginal speculum.Search strategy MEDLINE, EMBASE, CINAHL and the Cochrane Library were searched for relevant articles. No filters or restrictions were placed on the searches.Selection criteria Randomised controlled trials (RCTs) that assess pain when comparing the vaginoscopic technique versus a traditional hysteroscopy in the outpatient setting.Data collection and analysis Two reviewers independently selected trials. Data were abstracted on quality, characteristics and results.Meta-analyses were performed using the random-effects model to calculate the standardised mean difference (SMD).Main results There were six trials (2851 participants). Data from four of these were meta-analysed, and we found that the use of the vaginoscopic approach to hysteroscopy was less painful than using the traditional technique (SMD )0.44, 95% CI from )0.65 to )0.22, I 2 = 58%). There was no significant difference in the number of failed procedures between groups (P = 0.38).Author's conclusions The vaginoscopic approach to outpatient hysteroscopy is successful and significantly reduces the pain experienced by patients during the procedure, compared with traditional techniques using a vaginal speculum. Vaginoscopy should become standard practice for endoscopic instrumentation of the uterine cavity in the outpatient setting.

Background Studies examining the use of pharmaceutical (prostaglandins, antiprogestogens) and mechanical (osmotic dilators) dilatation of the cervix before hysteroscopy under general anaesthesia have produced conflicting results regarding their effect on cervical dilatation and trauma during the procedure.Objective To compare the effect on pain and need for cervical dilatation of various methods of cervical preparation before outpatient hysteroscopy.Search strategy MEDLINE, EMBASE and CINAHL were searched using a combination of the keywords 'hysteroscopy', 'vaginoscopy', 'cervical ripening', 'laminaria', 'progest*', 'prostaglandin', 'oestrogen' 'cervical preparation' and their associated Medical Subject Headings The Cochrane Library was searched using the keywords 'hysteroscopy' and 'cervical'. There were no limits or filters placed on the searches.Selection criteria Randomised controlled trials that examined women undergoing outpatient hysteroscopy, where the intervention was the use of cervical preparation versus a control or placebo and the outcome was pain assessment.Data collection and analysis Two reviewers independently selected trials. Data were extracted on pain, the effect on dilatation, adverse effects, trauma and feasibility. Data regarding pain and cervical dilatation were unsuitable for meta-analysis. Meta-analyses were performed for adverse effects and feasibility using the random effects models to calculate the Peto odds ratio.Results From 585 abstracts, six studies were selected for inclusion in the systematic review. The results suggest that there may be a benefit of using prostaglandins for postmenopausal women; however, there is no high-quality evidence that giving misoprostol before outpatient hysteroscopy reduces the pain experienced by women of reproductive age. There is some evidence that prostaglandins reduce the force and requirement for dilatation of the cervix beyond 5 mm.Author's conclusions There is no evidence to recommend the routine administration of mifepristone or misoprostol to women before outpatient hysteroscopy. Cervical priming with vaginal prostaglandins may be considered in postmenopausal women if using hysteroscopic systems >5 mm in diameter.