27 research outputs found
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
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
Dioxins contamination in the feed additive (feed grade cupric sulfate) tied to chlorine industry
Exercise cardiac output is maintained with advancing age in healthy human subjects: cardiac dilatation and increased stroke volume compensate for a diminished heart rate.
The role of inflammation in insulitis and beta-cell loss in type 1 diabetes.
Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disease with a strong inflammatory component. The latest studies indicate that innate immunity and inflammatory mediators have a much broader role in T1DM than initially assumed. Inflammation might contribute to early induction and amplification of the immune assault against pancreatic beta cells and, at later stages, to the stabilization and maintenance of insulitis. Inflammatory mediators probably contribute to the suppression of beta-cell function and subsequent apoptosis; they may also inhibit or stimulate beta-cell regeneration and might cause peripheral insulin resistance. The different effects of inflammation take place in different phases of the course of T1DM, and should be considered in the context of a 'dialog' between invading immune cells and the target beta cells. This dialog is mediated both by cytokines and chemokines that are released by beta cells and immune cells, and by putative, immunogenic signals that are delivered by dying beta cells. In this Review, we divided the role of inflammation in T1DM into three arbitrary stages: induction, amplification and maintenance or resolution of insulitis. These stages, and their progression or resolution, might depend on a patient's genetic background, which contributes to disease heterogeneity.Journal ArticleResearch Support, Non-U.S. Gov'tReviewinfo:eu-repo/semantics/publishe