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

Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study

Study Question Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting? Summary Answer Consensus definitions for individual core outcomes, contextual statements, and a standardized reporting table have been developed. What is Known Already Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development. Study Design, Size, Duration Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process. Participants/Materials, Setting, Methods Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus development methods. Main Results and the Role of Chance Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines, and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting. Limitations, Reasons for Caution We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries. Wider Implications of the Findings A minimum data set should assist researchers in populating protocols, case report forms, and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals have committed to implementing this core outcome set

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 (RCT) 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, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set

Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study

STUDY QUESTION Can consensus definitions for the core outcome set for infertility be identified in order to recommend a standardized approach to reporting? SUMMARY ANSWER Consensus definitions for individual core outcomes, contextual statements and a standardized reporting table have been developed. WHAT IS KNOWN ALREADY Different definitions exist for individual core outcomes for infertility. This variation increases the opportunities for researchers to engage with selective outcome reporting, which undermines secondary research and compromises clinical practice guideline development. STUDY DESIGN, SIZE, DURATION Potential definitions were identified by a systematic review of definition development initiatives and clinical practice guidelines and by reviewing Cochrane Gynaecology and Fertility Group guidelines. These definitions were discussed in a face-to-face consensus development meeting, which agreed consensus definitions. A standardized approach to reporting was also developed as part of the process. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus development methods. MAIN RESULTS AND THE ROLE OF CHANCE Forty-four potential definitions were inventoried across four definition development initiatives, including the Harbin Consensus Conference Workshop Group and International Committee for Monitoring Assisted Reproductive Technologies, 12 clinical practice guidelines and Cochrane Gynaecology and Fertility Group guidelines. Twenty-seven participants, from 11 countries, contributed to the consensus development meeting. Consensus definitions were successfully developed for all core outcomes. Specific recommendations were made to improve reporting. LIMITATIONS, REASONS FOR CAUTION We used consensus development methods, which have inherent limitations. There was limited representation from low- and middle-income countries. WIDER IMPLICATIONS OF THE FINDINGS A minimum data set should assist researchers in populating protocols, case report forms and other data collection tools. The generic reporting table should provide clear guidance to researchers and improve the reporting of their results within journal publications and conference presentations. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials statement, and over 80 specialty journals have committed to implementing this core outcome set

Nanostructure, electronic device having such nanostructure and method of preparing nanostructures

The compound nanotubes of InP or another II-VI or III-V material show a very large blueshift. Thus, devices with photoluminescent and electroluminescent effects in the visible range of the electromagnetic spectrum are provided by the inclusion of such nanotubes

Fabricating a set of semiconducting nanowires, and electric device comprising a set of nanowires

The method of fabricating a set of semiconducting nanowires ( 10 ) having a desired wire diameter (d) comprises the steps of providing a set of pre-fabricated semiconducting nanowires ( 10 '), at least one pre-fabricated semiconducting nanowire having a wire diameter (d') larger than the desired wire diameter (d), and reducing the wire diameter of the at least one pre-fabricated nanowire ( 10 ') by etching, the etching being induced by light which is absorbed by the at least one pre-fabricated nanowire ( 10 '), a spectrum of the light being chosen such that the absorption of the at least one pre-fabricated nanowire being significantly reduced when the at least one pre-fabricated nanowire reaches the desired wire diameter (d). The electric device ( 100 ) may comprise a set of nanowires ( 10 ) having the desired wire diameter (d). The apparatus ( 29 ) may be used to execute the method according to the invention

Semiconductor device with tunable energy band gap

The present invention relates to a semiconductor device in which energy band gap can be reversibly varied. An idea of the present invention is to provide a device, which is based on a semiconducting material (306) in mechanical contact with a material that exhibits a reversible volume change when properly addressed, e.g. a phase change material (307). The device can, for example, be implemented in light emitting, switching and memory in applications. The semiconducting material can be reversibly strained by applying a local volume expansion to the phase change material. The resulting band gap variation of the semiconducting material can be utilized to tune the color of the light emitted from e.g. an LED or a laser. In other fields of application, contact resistance in semiconductor junctions can be controlled, and this feature is highly advantageous in memories and switches

Nanowire semiconductor device

Semiconductor devices may be fabricated using nanowires. In an example embodiment, a conductive gate may be used to control conduction along the nanowires, in which case one of the contacts is a drain and the other a source. The nanowires may be grown in a trench or through-hole in a substrate or in particular in an epitaxial layer on substrate. In another example embodiment, the gate may be provided only at one end of the nanowires. The nanowires can be of the same material along their length; alternatively different materials can be used, especially different materials adjacent to the gate and between the gate and the base of the trench

The effect of friction on scratch adhesion testing : application to a sol-gel coating on polypropylene

The scratch test has long been used to study the adhesion of coatings. In this test an indenter is drawn across the surface of a coating under an increasing (continuous or stepwise) load. The load (normal to the surface) at which detachment of the coating occurs is termed the critical load. Usually, the magnitude of the critical load is related to the adhesion between the substrate and the coating by some theoretical model. It is well known that apart from the adhesion the critical load depends on several other parameters including the friction coefficient. In this paper a review of theoretical models applicable to scratch adhesion testing is given. Experimental data is used to compare the ability of these theoretical models to describe the effect of friction between the indenter and the coating on the critical load. We applied the scratch test to a model system consisting of a (hybrid) sol-gel coating deposited on polypropylene. The friction coefficient between indenter and coating was varied by a short plasma modification of the surface of the coating, while all other relevant parameters (i.e. interfacial adhesion, layer thickness, E-modulus of the coating, etc.) remained constant. The critical load (normal to the surface) showed a pronounced decrease of more than an order of magnitude with increasing friction coefficient. Several models are discussed and compared to the experimental data. In addition, the effect of substrate pretreatment on coating adhesion was studied. The adhesion of the sol-gel coating induced by microwave oxygen plasma modification of polypropylene is considerably better than the adhesion obtained by wet-chemical modification in chromo-sulfuric acid at room temperature. The adhesion induced by immersion in chromosulfuric acid is shown to be independent of the immersion time between 1 and 10 min

Semiconductor device comprising a pn-heterojunction

An electric device is disclosed comprising a pn-heterojunction ( 4 ) formed by a nanowire ( 3 ) of 111 -V semiconductor material and a semiconductor body ( 1 ) comprising a group IV semiconductor material. The nanowire ( 3 ) is positioned in direct contact with the surface ( 2 ) of the semiconductor body ( 1 ) and has a first conductivity type, the semiconductor body ( 1 ) has a second conductivity type opposite to the first conductivity type, the nanowire ( 3 ) forming with the semiconductor body ( 1 ) a pn-heterojunction ( 4 ). The nanowire of III-V semiconductor material can be used as a diffusion source ( 5 ) of dopant atoms into the semiconductor body. The diffused group III atoms and/or the group V atoms from the III-V material are the dopant atoms forming a region ( 6 ) in the semiconductor body in direct contact with the nanowire ( 3 )