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

Community-based post-stroke service provision and challenges: a national survey of managers and inter-disciplinary healthcare staff in Ireland

<p>Abstract</p> <p>Background</p> <p>The extent of stroke-related disability typically becomes most apparent after patient discharge to the community. As part of the Irish National Audit of Stroke Care (INASC), a national survey of community-based allied health professionals and public health nurses was conducted. The aim was to document the challenges to service availability for patients with stroke in the community and to identify priorities for service improvement.</p> <p>Methods</p> <p>The study was a cross-sectional tailored interview survey with key managerial and service delivery staff. As comprehensive listings of community-based health professionals involved in stroke care were not available, a cascade approach to information gathering was adopted. Representative regional managers for services incorporating stroke care (N = 7) and disciplinary allied health professional and public health nurse managers (N = 25) were interviewed (94% response rate).</p> <p>Results</p> <p>Results indicated a lack of formal, structured community-based services for stroke, with no designated clinical posts for stroke care across disciplines nationally. There was significant regional variation in availability of allied health professionals. Considerable inequity was identified in patient access to stroke services, with greater access, where available, for older patients (≥ 65 years). The absence of a stroke strategy and stroke prevalence statistics were identified as significant impediments to service planning, alongside organisational barriers limiting the recruitment of additional allied health professional staff, and lack of sharing of discipline-specific information on patients.</p> <p>Conclusions</p> <p>This study highlighted major gaps in the provision of inter-disciplinary team community-based services for people with stroke in one country. Where services existed, they were generic in nature, rarely inter-disciplinary in function and deficient in input from salient disciplines. Challenges to optimal care included the need for strategic planning; increased funding of healthcare staff; increased team resources and teamwork; and removal of service provision barriers based on age. There were notably many challenges beyond funding. Similar evaluations in other healthcare systems would serve to provide comparative lessons to serve to tackle this underserved aspect of care for patients with stroke and their families.</p

Search for Z \u27 -\u3e e(+) e(-) using dielectron mass and angular distribution

We search for Z(\u27) bosons in dielectron events produced in p (p) over bar collisions at root s=1.96 TeV, using 0.45 fb(-1) of data accumulated with the Collider Detector at Fermilab II detector at the Fermilab Tevatron. To identify the Z(\u27)-\u3e e(+)e(-) signal, both the dielectron invariant mass distribution and the angular distribution of the electron pair are used. No evidence of a signal is found, and 95% confidence level lower limits are set on the Z(\u27) mass for several models. Limits are also placed on the mass and gauge coupling of a generic Z(\u27), as well as on the contact-interaction mass scales for different helicity structure scenarios