Developing a core outcome set for future infertility research : An international consensus development study

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form

Perinatal mortality following assisted reproductive technology treatment in Australia and New Zealand, a public health approach for international reporting of perinatal mortality

BACKGROUND There is a need to have uniformed reporting of perinatal mortality for births following assisted reproductive technology (ART) treatment to enable international comparison and benchmarking of ART practice. METHODS The Australian and New Zealand Assisted Reproduction Database was used in this study. Births of ≥ 20 weeks gestation and/or ≥ 400 grams of birth weight following embryos transfer cycles in Australia and New Zealand during the period 2004 to 2008 were included. Differences in the mortality rates by different perinatal periods from a gestational age cutoff of ≥ 20, ≥ 22, ≥ 24, or ≥ 28 weeks (wks) to a neonatal period cutoff of either < 7 or < 28 days after birth were assessed. Crude and specific (number of embryos transferred and plurality) rates of perinatal mortality were calculated for selected gestational and neonatal periods. RESULTS When the perinatal period is defined as ≥ 20 wks gestation to < 28 days after birth, the perinatal mortality rate (PMR) was 16.1 per 1000 births (n = 630). A progressive contraction of the gestational age groups resulted in marked reductions in the PMR for deaths at < 28 days (22 wks 11.0; 24 wks 7.7; 28 wks 5.6); and similarly for deaths at < 7 days (20 wks 15.6, 22 wks 10.5; 24 wks 7.3; 28 wks 5.3). In contrast, a contraction of the perinatal period from < 28 to < 7 days after birth only marginally reduced the PMR from 16.2 to 15.6 per 1000 births which was consistent across all gestational ages. The PMR for single embryo transfer (SET) births (≥ 20 weeks gestation to < 7 days post-birth) was significantly lower (12.8 per 1000 SET births) compared to double embryo transfer (DET) births (PMR 18.3 per 1000 DET births; p < 0.001, Fisher’s Exact Test). Similarly, the PMR for SET births (≥ 22 weeks gestation to < 7 days post-birth) was significantly lower (8.8 per 1000 SET births, p < 0.001, Fisher’s Exact Test) when compared to DET births (12.2 per 1000 DET births). The highest PMR (50.5 per 1000 SET births, 95% CI 36.5-64.5) was for twins following SET births (≥ 20 weeks gestation to < 7 days post-birth) compared to twins following DET (23.9 per 1000 DET births, 95% CI 20.8-27.1). CONCLUSION Reporting of perinatal mortality of ART births is an essential component of quality ART practice. This should include measures that monitor the impact on perinatal mortality of multiple embryo transfer. We recommend that reporting of perinatal deaths following ART treatment, should be stratified for three gestation-specific perinatal periods of ≥ 20, ≥ 22 and ≥ 28 completed weeks to < 7 days post-birth; and include plurality specific rates by SET and DET. This would provide a valuable international evidence-base of PMR for use in evaluating ART policy, practice and new research.Elizabeth A Sullivan, Yueping A Wang, Robert J Norman, Georgina M Chambers, Abrar Ahmad Chughtai and Cynthia M Farquha

\u27I don\u27t want to cause any trouble\u27: the attitudes of hospital patients towards patient empowerment strategies to reduce healthcare-acquired infections

Background: Patients have, traditionally, been assumed to be the passive party in the healthcare-associated infections equation, with relatively little research focused on the patients\u27 perspective. This study aimed to explore the attitudes of hospital patients towards patient empowerment as one of the key components of patient engagement. Methods: Semi-structured interviews were undertaken with surgical patients from a major public hospital in Sydney, Australia. Findings: While participants acknowledged that patients could play a role in preventing infections while in hospital, that role was largely associated with maintaining their own personal hygiene. No reference was made to patients interacting with staff members. Some participants said that they would feel comfortable and happy to engage with staff, while others voiced concerns. Some about not wanting to \u27cause trouble or start fires\u27 and therefore would not tell staff members to perform hand hygiene. Some participants articulated a fear that their care may be negatively affected if they directly engaged or confronted clinicians about their behaviours. Conclusion: We found that patient engagement remains an underused method of preventing healthcare-associated infections, and the deep-seated public fears about individual vulnerabilities still need to be addressed

Empowering patients in the hospital as a new approach to reducing the burden of health care-associated infections: the attitudes of hospital health care workers

Background: Any approach promoting a culture of safety and the prevention of health care-associated infections (HCAIs) should involve all stakeholders, including by definition the patients themselves. This qualitative study explored the knowledge and attitudes of health care workers toward the concept of patient empowerment focused on improving infection control practices. Methods: Semi-structured interviews were undertaken with 29 staff from a large hospital in Sydney, Australia. Results: There was virtually unanimous agreement among the participants that patients should be thought of as a stakeholder and should have a role in the prevention of HCAI. However, the degree of patient responsibility and level of system engagement varied. Although very few had previously been exposed to the concept of empowerment, they were accepting of the idea and were surprised that hospitals had not yet adopted the concept. However, they felt that a lack of support, busy workloads, and negative attitudes would be key barriers to the implementation of any empowerment programs. Conclusion: Although the World Health Organization has recommended that patients have a role in encouraging hand hygiene as a means of preventing infection, patient engagement remains an underused method. By extending the concept of patient empowerment to a range of infection prevention opportunities, the positive impact of this intervention will not only extend to the patient but to the system itself

Cost-benefit analysis of a national influenza vaccination program in preventing hospitalisation costs in Australian adults aged 50-64 years old

Introduction: Influenza causes a significant burden among Australian adults aged 50–64, however, vaccine coverage rates remain suboptimal. The National Immunisation Program (NIP) currently funds influenza vaccinations in this age group only for those at high risk of influenza complications. Aims: The main aim of this study was to determine whether a strategy of expanding the government-funded vaccination program to all adults 50–64 in preventing influenza-related hospitalisations will be cost beneficial to the government. Methods: A cost-benefit analysis from a governmental perspective was performed using parameters informed by publicly available databases and published literature. Costs included cost of vaccinations and general practitioner consultation while benefits included the savings from averted respiratory and acute myocardial infarction (AMI) hospitalisations. Results: In the base-case scenario, the proposed policy would prevent 314 influenza/pneumonia, 388 other respiratory and 1482 AMI hospitalisations in a year. The government would save $8.03 million with an incremental benefit-cost ratio of 1.40. Most savings were due to averted AMI hospitalisations. In alternative scenarios cost savings ranged from saving of$31.4 million to additional cost to the government of $15.4 million, with sensitive variation in vaccine administration practices (through general practitioner or pharmacists) and vaccine effectiveness estimates. Discussion: Extension of the NIP to include adults 50–64 years of age is likely to be cost beneficial to the government, although this finding is sensitive to vaccine administration cost, which varies if provided through general practitioners or pharmacists; and to variation in vaccine effectiveness. An increased role of pharmacists in immunisation programs would likely result in cost savings in an expanded adult immunisation program

Translation of Real-Time Infectious Disease Modeling into Routine Public Health Practice

Infectious disease dynamic modeling can support outbreak emergency responses. We conducted a workshop to canvas the needs of stakeholders in Australia for practical, real-time modeling tools for infectious disease emergencies. The workshop was attended by 29 participants who represented government, defense, general practice, and academia stakeholders. We found that modeling is underused in Australia and its potential is poorly understood by practitioners involved in epidemic responses. The development of better modeling tools is desired. Ideal modeling tools for operational use would be easy to use, clearly indicate underlying parameterization and assumptions, and assist with policy and decision making

Ask, speak up, and be proactive: empowering patient infection control to prevent health care-acquired infections

Background: Over the last decade, there has been a slow shift toward the more active engagement of patients and families in preventing health care-associated infections (HCAIs). This pilot study aimed to examine the receptiveness of hospital patients toward a new empowerment tool aimed at increasing awareness and engagement of patients in preventing HCAI. Methods: Patients from the surgical department were recruited and randomized into 2 groups: active and control. Patients in the active arm were given an empowerment tool, whereas control patients continued with normal practices. Pre- and postsurveys were administered. Results: At the baseline survey, just over half of the participants were highly willing to assist with infection control strategies. Participants were significantly more likely to be willing to ask a doctor or nurse a factual question then a challenging question. After discharge, 23 of the 60 patients reported discussing a health concern with a staff member; however, only 3 participants asked a staff member to wash their hands. Conclusion: Our results suggest that patients would like to be more informed about HCAIs and are willing to engage with staff members to assist with the prevention of infections while in the hospital setting. Further work is going to need to be undertaken to ascertain the best strategies to promote engagement and participation in infection control activities

Current knowledge of COVID-19 and infection prevention and control strategies in healthcare settings: A global analysis.

Objective: In the current absence of a vaccine for COVID-19, public health responses aim to break the chain of infection by focusing on the mode of transmission. We reviewed the current evidence on the transmission dynamics and on pathogenic and clinical features of COVID-19 to critically identify any gaps in the current infection prevention and control (IPC) guidelines. Methods: In this study, we reviewed global COVID-19 IPC guidelines by organizations such as the World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), and the European Centre for Disease Prevention and Control (ECDC). Guidelines from 2 high-income countries (Australia and United Kingdom) and from 1 middle-income country (China) were also reviewed. We searched publications in English on ‘PubMed’ and Google Scholar. We extracted information related to COVID-19 transmission dynamics, clinical presentations, and exposures that may facilitate transmission. We then compared these findings with the recommended IPC measures. Results: Nosocomial transmission of SARS-CoV-2 in healthcare settings occurs through droplets, aerosols, and the oral–fecal or fecal–droplet route. However, the IPC guidelines fail to cover all transmission modes, and the recommendations also conflict with each other. Most guidelines recommend surgical masks for healthcare providers during routine care and N95 respirators for aerosol-generating procedures. However, recommendations regarding the type of face mask varied, and the CDC recommends cloth masks when surgical masks are unavailable. Conclusion: IPC strategies should consider all the possible routes of transmission and should target all patient care activities involving risk of person-to-person transmission. This review may assist international health agencies in updating their guidelines

A model of influenza infection and vaccination in children aged under 5 years in Beijing, China

Background Children aged under 5 years are particularly vulnerable to influenza infection. In this study, we aim to estimate the number and incidence of influenza among young children and estimate the impact of childhood vaccination in different scenarios from 2013/14 to 2016/17 seasons. Methods The number and incidence rate of influenza infections among children aged under 5 years in Beijing was estimated by scaling up observed surveillance data. Then, we used a susceptible–exposed–infected–recovery (SEIR) model to reproduce the weekly number of influenza infections estimated in Beijing during the study seasons, and to estimate the number and proportion of influenza-attributed medically attended acute respiratory infections (I-MAARI) averted by vaccination in each season. Finally, we evaluated the impact of alternative childhood vaccination programs with different coverage and speed of vaccine distribution. Results The estimated average annual incidence of influenza in children aged under 5 years was 33.9% (95% confidence interval (CI): 27.5%, 47.2%) during the study period. With the actual coverage during the included seasons at around 2.9%, an average of 3.9% (95%CI: 3.5%, 4.4%) I-MAARI was reduced compared to a no-vaccination scenario. Reaching 20%, 40%, 50%, 60%, 80% and 100% vaccine coverage would lead to an overall I-MAARI reduction of 25.3%, 42.7%, 51.9%, 57.0%, 65.3% and 71.2%. At 20% coverage scenario, an average of 28.8% I-MAARI will be prevented if intensive vaccination implemented in 2 months since the vaccine released. Conclusion In Beijing, the introduction of a program for vaccinating young children, even at relatively low vaccine coverage rates, would considerably reduce I-MAARI, particularly if the vaccines can be quickly delivered