The effectiveness of immediate versus delayed tubal flushing with oil-based contrast in women with unexplained infertility (H2Oil-timing study): study protocol of a randomized controlled trial.

BACKGROUND: In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live births as compared to tubal flushing with water-based contrast during hysterosalpingography. However, it is unknown whether incorporating tubal flushing with oil-based contrast in the initial fertility work-up results to a reduced time to conception leading to live birth when compared to delayed tubal flushing that is performed six months after the initial fertility work-up. We also aim to evaluate the effectiveness of tubal flushing with oil-based contrast during hysterosalpingography versus no tubal flushing in the first six months of the study. METHODS: This study will be an investigator-initiated, open-label, international, multicenter, randomized controlled trial with a planned economic analysis alongside the study. Infertile women between 18 and 39 years of age, who have an ovulatory cycle, who are at low risk for tubal pathology and have been advised expectant management for at least six months (based on the Hunault prediction score) will be included in this study. Eligible women will be randomly allocated (1:1) to immediate tubal flushing (intervention) versus delayed tubal flushing (control group) by using web-based block randomization stratified per study center. The primary outcome is time to conception leading to live birth with conception within twelve months after randomization. We assess the cumulative conception rate at six and twelve months as two co-primary outcomes. Secondary outcomes include ongoing pregnancy rate, live birth rate, miscarriage rate, ectopic pregnancy rate, number of complications, procedural pain score and cost-effectiveness. To demonstrate or refute a shorter time to pregnancy of three months with a power of 90%, a sample size of 554 women is calculated. DISCUSSION: The H2Oil-timing study will provide insight into whether tubal flushing with oil-based contrast during hysterosalpingography should be incorporated in the initial fertility work-up in women with unexplained infertility as a therapeutic procedure. If this multicenter RCT shows that tubal flushing with oil-based contrast incorporated in the initial fertility work-up reduces time to conception and is a cost-effective strategy, the results may lead to adjustments of (inter)national guidelines and change clinical practice. TRIAL REGISTRATION NUMBER: The study was retrospectively registered in International Clinical Trials Registry Platform (Main ID: EUCTR2018-004153-24-NL).

Oil-based versus water-based contrast media for hysterosalpingography in infertile women of advanced age, with ovulation disorders or a high risk for tubal pathology: study protocol of a randomized controlled trial (H2Oil2 study).

BACKGROUND: In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography (HSG) increases ongoing pregnancy and subsequent live birth rates when compared to tubal flushing with water-based contrast. It is currently unclear whether an HSG with oil-based contrast also results in more ongoing pregnancies and live births in women of advanced age, women with ovulation disorders, and women with potential tubal pathology when compared to an HSG with water-based contrast. METHODS: We plan an international, multicentre, open-label, randomized controlled trial (RCT) studying three groups of infertile women who have an indication for tubal patency testing according to their treating physician and additionally; (1) are 39 years of age or older, (2) have an ovulation disorder or (3) have a high risk for tubal pathology based on their medical history. Women with an allergy for iodinated contrast medium are excluded, as are women with diabetes, hyperprolactinemia or untreated hyper- or hypothyroidism, and women with a partner with severe male infertility. After informed consent, women will be randomly allocated to the intervention, tubal flushing with the use of oil-based contrast during HSG or the control group, tubal flushing with the use of water-based contrast during HSG in a 1:1 ratio by the web-based system Castor. The primary endpoint will be ongoing pregnancy leading to live birth with conception within six months after randomization. Secondary outcomes are other pregnancy outcomes, used fertility treatments, adverse events and cost-effectiveness. Based on the expected ongoing pregnancy rate of 17% in the control group and 27% in the intervention group, the sample size will be 930 women (465 per group). Study inclusion is expected to be complete in four years. DISCUSSION: This multicentre RCT will establish whether, for women of advanced age, women with ovulatory disease, and women who have a high risk for tubal pathology, there is a fertility enhancing effect of tubal flushing with oil-based contrast during HSG and whether the use of this contrast medium is cost-effective. Trial Registration The study was prospectively registered in the Netherlands Trial Register on August 1st 2019 as 'H2Oil2' (reference number NL7925, https://www.trialregister.nl/trial/7925 ).

Can humanization theory contribute to the philosophical debate in public health?

This paper will explore the humanization value framework for research, policy and practice with regard to its relevance for public health, specifically the reduction of inequities in health. This proposed framework introduces humanizing values to influence research, policy and practice. The framework is articulated through eight specific constituents of what it is to be human. These dimensions are articulated as humanizing and dehumanizing dimensions that have the potential to guide both research and practice. The paper will then go on to consider these dimensions in relation to the emergent qualities of the potential 'fifth-wave' of public health intervention. The humanization dimensions outlined in this paper were presented as emerging from Husserl's notion of lifeworld, Heidegger's contemplations about human freedom and being with others, and Merleau-Ponty`s ideas about body subject and body object. Husserl's ideas about the dimensions that make up 'lifeworld', such as embodiment, temporality and spatiality, underpin the suggested dimensions of what it is to be human. They are proposed in the paper as together informing a value base for considering the potentially humanizing and dehumanizing elements in systems and interactions. It is then proposed that such a framework is useful when considering methods in public health, particularly in relation to developing new knowledge of what is both humanizing and dehumanizing within research and practice.

Surfing the net for public health resources.

OBJECTIVES: To identify public health open educational resources (OER) available online, map the identified OER to The Public Health Skills and Career Framework (PHSCF), and triangulate these findings with public health practitioners. STUDY DESIGN: Systematic online search for public health OER. METHODS: An online search was undertaken using a pre-defined set of search terms and inclusion/exclusion criteria. Public health OER were then mapped against the UK PHSCF. The findings of the search were discussed with public health specialists to determine whether or not they used these resources. RESULTS: A number of public health OER were identified, located on 42 websites from around the world. Mapping against the UK PHSCF demonstrated a lack of coverage in some areas of public health education. It was noted that many of the OER websites identified were not those generally used in practice, and those sites preferred by public health specialists were not identified by the online search. CONCLUSIONS: Public health OER are available from a number of providers, frequently universities and government organizations. However, these reflect a relatively small pool of original OER providers. Tagging of websites does not always identify their public health content. In addition, users of public health OER may not use search engines to identify resources but locate them using other means.

Sustainable Urban Drainage Systems (SUDS) treatment train assessment tool.

This paper outlines a rationale and scoring system for the stormwater treatment train assessment tool (STTAT) which is a proposed regulatory tool for Sustainable Urban Drainage Systems (SUDS). STTAT provides guidance and regulatory consistency for developers about the requirements of planners and the Scottish Environment Protection Agency (SEPA). The tool balances the risks of pollution to the receiving water body with the treatment provided in a treatment train. It encourages developers to take SUDS into account early, avoiding any misunderstanding of SUDS requirements at the planning stage of a development. A pessimistic view on pollution risks has been adopted since there may be a change of land use on the development in the future. A realistic view has also been taken of maintenance issues and the 'survivability' of a SUDS component. The development of STTAT as a response to the requirements of the Water Framework Directive is explored, the individual scores being given in tabular format for receiving water and catchment risks. Treatment scores are proposed for single SUDS components as well as multiple components within treatment trains. STTAT has been tested on a range of sites, predominantly in Scotland where both development and receiving water information was known. The operational tool in use by SEPA is presented.

Angiodysplasia as a cause of iron deficiency anaemia.

Angiodysplasia, a condition of unknown aetiology, is thought to represent the commonest cause of obscure gastrointestinal bleeding, particularly in the elderly population. The lesions of angiodysplasia, which are small (less than 5 mm) and usually multiple, consist of microvascular abnormalities in the mucosa and submucosa of the bowel wall. They are most commonly found in the caecum and right side of the colon, but have been observed in the stomach, ileum and elsewhere in the colon. The diagnosis is made by either selective visceral angiography and/or colonoscopy, but the lesions cannot be detected on barium studies or with the naked eye at laparotomy. Localisation of the abnormalities by the histopathologist is greatly facilitated by special injection techniques demonstrating the blood vessels of resected colonic specimens prior to fixation and section. Treatment may be conservative (iron replacement) if the anaemia is not severe, by endoscopic fulguration or by colonic resection. Other common causes of gastrointestinal blood loss should always be excluded before the final diagnosis of angiodysplasia is accepted. Although the condition is well recognised as a significant cause of gastrointestinal blood loss a number of questions remain to be answered. The true incidence of angiodysplasia in the population is not known, the aetiology of the condition remains a mystery, although many theories abound.

Noninvasive measurement of renal blood flow with technetium-99m-DTPA in the evaluation of patients with suspected renovascular hypertension.

If a hypertensive patient with renal artery stenosis (RAS) is to benefit from percutaneous transluminal renal angioplasty (PTRA) in terms of a sustained improvement in blood pressure control, one may postulate a demonstrable reduction in renal blood flow (RBF) to that kidney, reversible by PTRA. In a population of 32 hypertensive patients, RAS was present in 23 of 62 kidneys. Eleven of the 32 patients underwent renal revascularization, of whom 6 showed improvement in blood pressure control at 6 mo, i.e., had renovascular hypertension (RVH). There was no correlation between RBF and angiographic appearances of the renal artery. Furthermore, there was no significant difference between RBF in the stenosed kidneys of the patients with RVH compared with the stenosed kidneys of patients without RVH. Individual kidney RBF was 22% (s.d. 11) higher 1-3 wk after PTRA but the increase did not correlate with clinical outcome. Angiotensin converting enzyme (ACE) inhibition increased RBF by 25% (s.d. 25) of baseline flow before PTRA but the increase did not correlate with clinical outcome. Measurement of RBF is of limited value for the prediction of the long-term blood pressure response following PTRA.

Antibody guided diagnosis and therapy of brain gliomas using radiolabeled monoclonal antibodies against epidermal growth factor receptor and placental alkaline phosphatase.

Twenty-seven patients with brain glioma were scanned using 123I-labeled monoclonal antibodies against epidermal growth factor receptor (EGFR1) or placental alkaline phosphatase (H17E2). Successful localization was achieved in 18 out of 27 patients. Eleven out of 27 patients were also studied using a nonspecific control antibody (11.4.1) of the same immunoglobulin subclass and observable tumor localization was also achieved in five patients. The specificity of targeting was assessed by comparing images obtained with specific and nonspecific antibodies and by examining tumor and normal tissue biopsies after dual antibody administration. Ten patients with recurrent grade III or IV glioma who showed good localization of radiolabeled antibody were treated with 40-140 mCi of 131I-labeled antibody delivered to the tumor area intravenously (n = 5) or by infusion into the internal carotid artery (n = 5). Six patients showed clinical improvement lasting from 6 mo to 3 yr. One patient continues in remission (3 yr after therapy), but the other five who responded initially relapsed 6-9 mo after therapy and died. No major toxicity was attributable to antibody-guided irradiation. Targeted irradiation by monoclonal antibody may be clinically useful and should be explored further in the treatment of brain gliomas resistant to conventional forms of treatment.

Effects of androgens on the transcription of secretory protein genes in rat seminal vesicle.

Run-on transcription in isolated nuclei has been used to study the effects of testosterone on gene expression in rat seminal vesicles. General transcriptional rates were increased by about 6-fold with an additional 2- to 3-fold differential stimulation of the genes for secretory proteins IV and V. These transcriptional changes are insufficient to explain overall changes in cellular mRNA levels, indicating that androgens must also have major effects on post-transcriptional processing of RNA transcripts or on mRNA stability. Analysis of nuclear RNA by Northern blotting with intron probes suggests substantial androgen effects on primary transcript processing.

Hemobilia. A disease in evolution.

Ten patients with hemobilia were treated over a six-year period. Six cases resulted from iatrogenic injury (percutaneous invasive procedures, four; surgical trauma, two); the others were caused by gallstone disease (two), liver trauma (one), and vasculitis (one). Five patients were treated successfully by selective arterial embolization. In the other five patients, embolization was not possible due to previous surgical and/or radiologic procedures, or it was contraindicated, and thus, surgical treatment was undertaken. One of these patients died. There were no long-term sequelae in the remaining nine patients followed up for 12 to 66 months. Selective hepatic arterial embolization is the treatment of choice for hemobilia. Inappropriate embolization or surgery frequently fails to control the bleeding and may also prevent later successful embolization.

The pre-operative embolisation of vascular malformations.

Large arteriovenous malformations frequently require surgical excision in order to prevent or treat the potentially serious problems they can cause ranging from haemorrhage and pain to cardiac failure. The surgery itself is usually difficult and often dangerous due to the serious risk of major intraoperative haemorrhage. Transcatheter arterial embolisation has greatly facilitated the management of small arteriovenous malformations but may only afford temporary relief of symptoms in very large lesions. Recanalisation of occluded vessels and revascularisation via previously insignificant collateral vessels means that large lesions cannot be effectively managed by this method alone. Previous surgery and ligation of feeding vessels may make effective embolisation difficult or impossible and a combined radiological and surgical approach to these lesions may permit definitive treatment. We present three cases in whom the pre-operative embolisation of buttock arteriovenous malformations facilitated successful surgical excision.

Carotid artery stenosis--reassessment of the Doppler criteria.

Few previous studies of the accuracy of duplex Doppler in the assessment of carotid artery stenosis have looked at the accuracy in excluding disease in populations with a significant number of normal arteries. In addition, few studies have compared different criteria for stenosis. Duplex Doppler was used to evaluate the carotid arteries in 80 patients. Two well-described methods for analysing Doppler traces were used and the results were compared with those obtained from non-selective digital subtraction angiography. On the basis of these findings, the Doppler criteria used for carotid stenosis were redefined in terms of changes in peak velocity rather than Doppler frequency shift. Using these criteria, the sensitivity of Doppler in identifying carotid stenosis was 97% (98% sensitivity for greater than 50% stenosis) and specificity was increased from 84% to 93%.

Selective visceral angiography in obscure postoperative gastrointestinal bleeding.

Postoperative gastrointestinal bleeding may be difficult to diagnose and treat. Selective visceral angiography localised the bleeding site in seven out of ten episodes of obscure postoperative gastrointestinal haemorrhage, and in two cases radiological embolisation was used successfully to control the bleeding. Angiography, preferably during an episode of haemorrhage, is recommended whenever possible for patients with undiagnosed postoperative gastrointestinal bleeding.

A comparison of colonoscopy and selective visceral angiography in the diagnosis of colonic angiodysplasia.

The results of selective visceral angiography and colonoscopy were compared in the diagnosis of angiodysplasia of the large bowel. Fifty six patients were diagnosed as having angiodysplasia on angiography and 34 of these patients also underwent colonoscopy. Twenty three of the colonoscopies were positive giving a diagnostic yield of 68%. Three colonoscopies were negative and eight were incomplete. Colonoscopy was useful in the diagnosis of concomitant disease and also provided the clinician with the therapeutic possibility of electrocoagulation. Colonoscopy at operation proved to be a valuable technique in assessing the extent of angiodysplasia prior to resection.

An emerging model for publishing and using open educational resources in public health.

INTRODUCTION: The open source revolution has enabled the development of open educational resources (OER) and the potential for sharing lessons learned. We present a potential model for publishing OER in public health to inform workforce development. METHODS: As part of the PHORUS (Public Health Open Resources for the University Sector) Project, a review of the literature relating to the development of OER was followed by an online search for OER resources relating specifically to public health. Furthermore, a Delphi study was conducted to identify and prioritize barriers and enablers to the production and use of public health OER. RESULTS: A wide array of OER literature was identified, although there were a limited number of public health-related papers. The key concepts influencing public health OER release found in the literature were identified as quality, ethics and values, rewards, risks and practical aspects, such as technological developments. These concepts were then further developed through the PHORUS project research findings to produce the basis of a potential model for OER development in public health. DISCUSSION/CONCLUSION: The synthesis of a literature review and Delphi study has produced a potential model to guide the development of OER in public health. The model provides a matrix where the questions about whether and how an academic can produce and publish OER are answered, according to various risks and benefits to them and their institution. We hope that this will provide practical assistance and encouragement for the academic public health community to create and share OER.

Hysterosalpingogram: an essential examination following Essure hysteroscopic sterilisation.

OBJECTIVES: The aim of this study was to describe our experience of imaging following hysteroscopic sterilisation with the Essure (Conceptus Inc., Mountain View, San Carlos, CA) microinsert, and to underline the importance of a carefully performed follow-up hysterosalpingogram (HSG) in the management of these patients. METHODS: 18 women underwent the procedure and all returned for follow-up HSG. A standard HSG technique was used and views were acquired to establish microinsert position and tubal occlusion. RESULTS: In 16 of the 18 women, adequate microinsert positioning and bilateral tubal occlusion was present. In one woman, a unilateral microinsert occluded the fallopian tube, whereas the other fallopian tube was ligated with a clip. The final patient underwent two studies; both showed well-positioned microinserts but unilateral free spill from the right fallopian tube. There are no reported pregnancies thus far. CONCLUSION: Essure sterilisation coils have a unique appearance when radiographed and are an effective means of permanently occluding the fallopian tubes. HSG is a rapid and safe method of confirming satisfactory placement and tubal occlusion. Non-HSG imaging techniques are suboptimal at detecting patent fallopian tubes and expose patients to the risk of an unwanted and potentially complicated pregnancy.

Enabling nursing students to focus on the Ottawa Charter and the nurses role in tackling inequalities in health through international exchange.

Student nurses in a transatlantic exchange program explored the role of registered nurses in five countries' public health systems. The Ottawa Charter provided a framework for students to examine the nurse's responsibilities in public health. Students took practice placements in geographically rural a reason another continent and explored inequalities in health care. If nurses are to understand their role in the health care system then they must be taught the scope of their practice including their role in health promotion,public health practice and community development. For this project nursing instructors developed an assignment relevant to the aims and suitable for students in all five nursing programs. Only three of 48 students offered an assignment which focused on building healthy public policy. Nurse educators need to explore this further to ensure nurses of the future are aware of their role and responsibilities in this area and have skills to work effectively to influence and build healthy policy. The international student exchange supported the students' developing understanding of the breadth of initiatives around the globe where nurses are actively engaged in addressing inequalities of health. Findings from an analysis of their assignments are presented in this evaluative report.