Advocating for adequate and reliable funding for sexual and reproductive health and rights: A call to action for clinicians

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Ultrasound imaging of the anal sphincter complex : a review

Endoanal ultrasound is now regarded as the gold standard for evaluating anal sphincter pathology in the investigation of anal incontinence. The advent of three-dimensional ultrasound has further improved our understanding of the twodimensional technique. Endoanal ultrasound requires specialised equipment and its relative invasiveness has prompted clinicians to explore alternative imaging techniques. Transvaginal and transperineal ultrasound have been recently evaluated as alternative imaging modalities. However, the need for technique standardisation, validation and reporting is of paramount importance. We conducted a MEDLINE search (1950 to February 2010) and critically reviewed studies using the three imaging techniques in evaluating anal sphincter integrity.http://www.bir.org.uk/bir-publications-home/bjr---about-the-journal.asp

Outcome of repair of obstetric anal sphincter injuries after three years

OBJECTIVE: To prospectively assess change in bowel symptoms and quality of life (QoL) approximately 3 years after primary repair of obstetric anal sphincter injuries (OASIS). METHODS: Between July 2002 and December 2007 women who attended the perineal clinic at Croydon University Hospital, UK, 9 weeks following primary repair of OASIS were asked to complete the Manchester Health Questionnaire and a questionnaire to obtain a St Mark incontinence score. All women had endoanal scans at this visit. In June 2008 all women were asked to complete the questionnaires again. RESULTS: Of 344 patients who responded to the questionnaires and were included in the analysis, long-term symptoms of fecal urgency, flatus incontinence, and fecal incontinence occurred in 62 (18.0%), 52 (15.1%), and 36 (10.5%), respectively. Overall, there was a significant improvement in fecal urgency (P < 0.001) and flatus incontinence (P < 0.001) from 9 weeks to 3 years. Of 31 women with fecal incontinence symptoms at early follow-up, 28 were asymptomatic at 3 years. However, 33 women developed de novo symptoms. The only predictors of fecal incontinence at 3 years were fecal urgency at 9 weeks (OR 4.65; 95% CI, 1.38–15.70) and a higher St Mark score (OR 1.40; 95% CI, 1.09–1.80). CONCLUSION: Following primary repair of OASIS, the majority of symptoms and QoL significantly improve, unless there is a persistent anal sphincter defect. This highlights the importance of adequate repair

The global burden of disease due to benign gynecological conditions: A call to action

Objective: Focusing on low‐ and middle‐income countries (LMICs), this article uses data from the Global Burden of Disease (GBD) database to highlight the burden of morbidity due to benign gynecological conditions (BGCs). Methods: We analyzed 2019 morbidity data for all BGCs, measured as years lost to disability (YLDs). Disease burden was calculated for individual conditions, BGCs overall, and percentages of overall disease burden from all conditions. The same data extraction was performed for malaria, tuberculosis, and HIV/AIDS for comparison. The data were subcategorized by age and World Bank income level. Results: BGCs are major causes of disease morbidity worldwide. For women aged 15 years and over in high‐income countries (HICs), 3 588 157 YLDs (3.94% of all YLDs) were due to BGC. In LMICs, 18 242 989 YLDs (5.35% of all YLDs) were due to BGCs. The highest burden of BGCs is seen during the reproductive years where conditions driven or exacerbated by reproductive hormones are the major causes of morbidity. In LMICs, for women aged 15–49, 14 574 100 YLDs (7.75% of all YLDs) were due to BGCs, declining to 3 152 313 YLDs (3.04%) in women aged 50–69 and 529 399 YLDs (1.06%) in women age 70+. Conclusion: These data demonstrate a huge burden of morbidity due to BGCs. There is an urgent need for international stakeholders to prioritize the treatment and prevention of BGCs

Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies.

Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common themes related to study design and management. Based on these, we comment and reflect on: (1) the balance that needs to be struck between fidelity to the study design and tailoring to emerging requests from participating sites as part of the research process, and (2) the modifications to the implementation strategies being evaluated. Hybrid trial teams should carefully consider the impact of design selection, trial management decisions, and any modifications to implementation processes and/or support on the delivery of a controlled evaluation. The rationale for these choices should be systematically reported to fill the gap in the literature

Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial

Background Risk factors for maternal infection are clearly recognised, including caesarean section and operative vaginal birth. Antibiotic prophylaxis at caesarean section is widely recommended because there is clear systematic review evidence that it reduces incidence of maternal infection. Current WHO guidelines do not recommend routine antibiotic prophylaxis for women undergoing operative vaginal birth because of insufficient evidence of effectiveness. We aimed to investigate whether antibiotic prophylaxis prevented maternal infection after operative vaginal birth. Methods In a blinded, randomised controlled trial done at 27 UK obstetric units, women (aged ≥16 years) were allocated to receive a single dose of intravenous amoxicillin and clavulanic acid or placebo (saline) following operative vaginal birth at 36 weeks gestation or later. The primary outcome was confirmed or suspected maternal infection within 6 weeks of delivery defined by a new prescription of antibiotics for specific indications, confirmed systemic infection on culture, or endometritis. We did an intention-to-treat analysis. This trial is registered with ISRCTN, number 11166984, and is closed to accrual. Findings Between March 13, 2016, and June 13, 2018, 3427 women were randomly assigned to treatment: 1719 to amoxicillin and clavulanic acid, and 1708 to placebo. Seven women withdrew, leaving 1715 in the amoxicillin and clavulanic acid group and 1705 in the placebo groups. Primary outcome data were missing for 195 (6%) women. Significantly fewer women allocated to amoxicillin and clavulanic acid had a confirmed or suspected infection (180 [11%] of 1619) than women allocated to placebo (306 [19%] of 1606; risk ratio 0·58, 95% CI 0·49–0·69; p<0·0001). One woman in the placebo group reported a skin rash and two women in the amoxicillin and clavulanic acid reported other allergic reactions, one of which was reported as a serious adverse event. Two other serious adverse events were reported, neither was considered causally related to the treatment. Interpretation This trial shows benefit of a single dose of prophylactic antibiotic after operative vaginal birth and guidance from WHO and other national organisations should be changed to reflect this

Isolated rectal buttonhole tears in obstetrics: case series and review of the literature.

INTRODUCTION AND HYPOTHESIS: The management of isolated rectal buttonhole tears is not standardised and can be challenging in an acute obstetric setting. Our aim was to review the published literature and describe management and repair techniques in a case series. METHODS: A literature search was carried out. All results were screened and reviewed. Rectal buttonhole tears following vaginal delivery between April 2012 and January 2020 in our institution were identified. Repair technique and post-operative management were recorded. RESULTS: There were nine published case reports (four instrumental deliveries, two vaginal breech and three normal vaginal deliveries). Four case reports described a two-layer closure and five described a three-layer closure. Two cases were repaired in collaboration with colorectal surgeons. All nine cases made an uneventful recovery. We identified three patients with buttonhole tears all of whom had instrumental deliveries. A colorectal surgeon repaired the tear in two layers in one case, and an obstetrician performed the repair in the other two cases, one in three layers and the other in two layers. One patient had a de-functioning stoma at a later date due to a second breakdown of the recto-vaginal fistula repair. CONCLUSION: Buttonhole tears are rare but techniques of repair vary. Most cases reviewed had an uneventful recovery after repair. We provide standardised steps for repair and management of isolated rectal buttonhole tears along with a video demonstrating the repair technique in an animal tissue (pig) model

Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial

Background: Prolapse affects 30–40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL). Methods: Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577. Findings: The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC −0.03, 95% CI −9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI −£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference −3.83%, 95% CI –6.86% to −0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC). Interpretation: Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate.</p

Review of available national guidelines for obstetric anal sphincter injury.

INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIs) are the most severe form of perineal trauma with potentially devastating effects on a mother's quality of life. There are various national guidelines available for their management. The aim of this study was to review and compare recommendations from published national guidelines regarding management and prevention of OASI. METHODS: We searched the PUBMED, EMBASE, MEDLINE, CINAHL and COCHRANE databases from January 2008 till October 2019 using relevant Medical Subject Headings (MeSH), including all subheadings. The guideline characteristics were mapped and methodological quality assessed with the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool by three independent reviewers. To compare the methodological quality of the guidelines, the interpretation of the six domain scores were taken into consideration. By consensus of the authors, a score of 70% was taken as a cut-off, and scores above this were considered 'high quality'. RESULTS: Thirteen national guidelines on perineal trauma were included and analysed. Nine of these were specific to OASI. There is wide variation in methodological quality and evidence used for recommendations. AGREE scores for overall guideline assessment were > 70% in eight of the guidelines, with Australia-Queensland, Canada, the UK and USA scoring highest. CONCLUSIONS: The wide variation in methodological quality and evidence used for recommendations suggests that there is a need for an agreed international guideline. This will enable healthcare practitioners to follow the same recommendations, with the most recent evidence, and provide evidence-based care to all women globally