Blastocyst quality and reproductive and perinatal outcomes: a multinational multicentre observational study.

STUDY QUESTION: Does the transfer of single low-grade blastocysts result in acceptable reproductive and perinatal outcomes compared to the transfer of single good-grade blastocysts? SUMMARY ANSWER: The transfer of single low-grade blastocysts resulted in a reduced live birth rate of around 30% (14% for very low-grade blastocysts) compared to 44% for single good-grade blastocysts, but does not lead to more adverse perinatal outcomes. WHAT IS KNOWN ALREADY: It is known that low-grade blastocysts can result in live births. However, the current studies are limited by relatively small sample sizes and single-centre designs. Furthermore, evidence on perinatal outcomes after transferring low-grade blastocysts is limited. STUDY DESIGN, SIZE, DURATION: We conducted a multi-centre, multi-national retrospective cohort study of 10 018 women undergoing 10 964 single blastocyst transfer cycles between 2009 and 2020 from 14 clinics across Australia, China, and New Zealand. PARTICIPANTS/MATERIALS, SETTING, METHODS: Blastocysts were graded individually based on assessment of the morphology and development of the inner cell mass (ICM) and trophectoderm (TE), and were grouped into three quality categories: good- (AB, AB, or BA), moderate- (BB), and low-grade (grade C for ICM or TE) blastocysts. CC blastocysts were individually grouped as very low-grade blastocysts. Logistic regression with generalized estimating equation was used to analyse the association between blastocyst quality and live birth as well as other reproductive outcomes. Binomial, multinomial logistic, or linear regression was used to investigate the association between blastocyst quality and perinatal outcomes. Odds ratio (OR), adjusted OR (aOR), adjusted regression coefficient, and their 95% CIs are presented. Statistical significance was set at P < 0.05. MAIN RESULTS AND THE ROLE OF CHANCE: There were 4386 good-grade blastocysts, 3735 moderate-grade blastocysts, and 2843 low-grade blastocysts were included in the analysis, for which the live birth rates were 44.4%, 38.6%, and 30.2%, respectively. Compared to good-grade blastocysts, the live birth rate of low-grade blastocysts was significantly lower (aOR of 0.48 (0.41-0.55)). Very low-grade blastocysts were associated with an even lower live birth rate (aOR 0.30 (0.18-0.52)) and their absolute live birth rate was 13.7%. There were 4132 singleton live births included in the analysis of perinatal outcomes. Compared with good-grade blastocysts, low-grade blastocysts had comparable preterm birth rates (<37 weeks, aOR 1.00 (0.65-1.54)), birthweight Z-scores (adjusted regression coefficient 0.02 (0.09-0.14)), and rates of very low birth weight (<1500 g, aOR 0.84 (0.22-3.25)), low birth weight (1500-2500 g, aOR 0.96 (0.56-1.65)), high birth weight (>4500 g, aOR 0.93 (0.37-2.32)), small for gestational age (aOR 1.63 (0.91-2.93)), and large for gestational age (aOR 1.28 (0.97-1.70)). LIMITATIONS, REASONS FOR CAUTION: Due to the nature of the retrospective design, residual confounding could not be excluded. In addition, the number of events for some perinatal outcomes was small. Between-operator and between-laboratory variations in blastocyst assessment were difficult to control. WIDER IMPLICATIONS OF THE FINDINGS: Patients undergoing IVF should be informed that low-grade blastocysts result in a lower live birth rate, however they do not increase the risk of adverse perinatal outcomes. Further research should focus on the criteria for embryos that should not be transferred and on the follow-up of long-term outcomes of offspring. STUDY FUNDING/COMPETING INTEREST(S): H.Z. is supported by a Monash Research Scholarship. B.W.J.M. is supported by a NHMRC Investigator grant (GNT1176437). R.W. is supported by an NHMRC Emerging Leadership Investigator grant (2009767). B.W.J.M. reports consultancy, travel support, and research funding from Merck. The other authors do not have competing interests to disclose. TRIAL REGISTRATION NUMBER: N/A.

Feature Engineering and Process Mining to Enable Hazard Detection in Health Information Technology.

In this work, we aim to enhance the reliability of health information technology (HIT) systems by detection of plausible HIT hazards in clinical order transactions. In the absence of well-defined event logs in corporate data warehouses, our proposed approach identifies relevant timestamped data fields that could indicate transactions in the clinical order life cycle generating raw event sequences. Subsequently, we adopt state transitions of the OASIS Human Task standard to map the raw event sequences and simplify the complex process that clinical radiology orders go through. We describe how the current approach provides the potential to investigate areas of improvement and potential hazards in HIT systems using process mining. The discussion concludes with a use case and opportunities for future applications.

Engaging Graduate-Level Distance Learners in Research: A Collaborative Investigation of Rural Aging.

Online educational programs pose challenges to nonresidential graduate students for whom research is a key professional development experience. In this article, the authors share their pedagogical approach to engaging graduate-level online distance learners in research. Five students enrolled in an online master's degree program participated in a directed research course designed to facilitate a semester-long, collaborative, hands-on research experience in gerontology. As such, students recruited participants and conducted phone interviews for a multisite study examining aging in place in rural areas. Several strategies were used to facilitate student engagement and learning, including: regular meetings with faculty mentors, creation of a research team across institutions, interactive training, and technological tools to aid in communication. The authors discuss the process of implementing the project, challenges that arose, strategies for dealing with these issues, and a pedagogical framework that could be used to guide future endeavors of this type.

Understanding barriers and facilitators to the use of Clinical Information Systems for intensive care units and Anesthesia Record Keeping: A rapid ethnography.

OBJECTIVE: This study evaluated the current use of commercial-off-the-shelf Clinical Information Systems (CIS) for intensive care units (ICUs) and Anesthesia Record Keeping (ARK) for operating rooms and post-anesthesia care recovery settings at three Veterans Affairs Medical Centers (VAMCs). Clinicians and administrative staff use these applications at bedside workstations, in operating rooms, at nursing stations, in physician's rooms, and in other various settings. The intention of a CIS or an ARK system is to facilitate creation of electronic records of data, assessments, and procedures from multiple medical devices. The US Department of Veterans Affairs (VA) Office of the Chief of Nursing Informatics sought to understand usage barriers and facilitators to optimize these systems in the future. Therefore, a human factors study was carried out to observe the CIS and ARK systems in use at three VAMCs in order to identify best practices and suggested improvements to currently implemented CIS and ARK systems. METHODS: We conducted a rapid ethnographic study of clinical end-users interacting with the CIS and ARK systems in the critical care and anesthesia care areas in each of three geographically distributed VAMCs. Two observers recorded interactions and/or interview responses from 88 CIS and ARK end-users. We coded and sorted into logical categories field notes from 69 shadowed participants. The team transcribed and combined data from key informant interviews with 19 additional participants with the observation data. We then integrated findings across observations into meaningful patterns and abstracted the data into themes, which translated directly to barriers to effective adoption and optimization of the CIS and ARK systems. RESULTS: Effective optimization of the CIS and ARK systems was impeded by: (1) integration issues with other software systems; (2) poor usability; (3) software challenges; (4) hardware challenges; (5) training concerns; (6) unclear roles and lack of coordination among stakeholders; and (7) insufficient technical support. Many of these barriers are multi-faceted and have associated sub-barriers, which are described in detail along with relevant quotes from participants. In addition, regionalized purchases of different CIS and ARK systems, as opposed to enterprise level purchases, contributed to some of the identified barriers. Facilitators to system use included (1) automation and (2) a dedicated facility-level CIS-ARK Coordinator. CONCLUSIONS: We identified barriers that explain some of the challenges with the optimization of the CIS and ARK commercial systems across the Veterans Health Administration (VHA). To help address these barriers, and evolve them into facilitators, we categorized report findings as (1) interface and system-level changes that vendors or VA healthcare systems can implement; (2) implementation factors under VA control and not under VA control; and (3) factors that may be used to inform future application purchases. We outline several recommendations for improved adoption of CIS and ARK systems and further recommend that human factors engineering and usability requirements become an integral part of VA health information technology (HIT) application procurement, customization, and implementation in order to help eliminate or mitigate some of the barriers of use identified in this study. Human factors engineering methods can be utilized to apply a user-centered approach to application requirements specification, application evaluation, system integration, and application implementation.

The delivery of distance education--is it time for doctoral programs in gerontology?

The delivery of higher education in gerontology is changing; students are now able to receive an education solely online. Perhaps it is time to consider offering this option at the doctoral level. A needs assessment was conducted to assess whether a doctoral program in gerontology should be created in the Great Plains Interactive Distance Education Alliance (GPIDEA) program. An online survey was sent to 247 students enrolled in the GPIDEA program and to students who had taken a GPIDEA course in gerontology but were not currently enrolled in the program. One hundred and twenty-three students began the survey, although only 120 students completed the survey. Findings indicated students are interested in a doctoral program in gerontology. Approximately 65% of students were interested in obtaining a PhD from a distance education program. However, an applied program focusing on community outreach and leadership was of most interest to students. Students were less interested in research-based programs or in research residency. Therefore, the development of distance education doctoral degree programs in gerontology may need to be created differently than "traditional" formats.

An analysis of electronic health record-related patient safety concerns.

OBJECTIVE: A recent Institute of Medicine report called for attention to safety issues related to electronic health records (EHRs). We analyzed EHR-related safety concerns reported within a large, integrated healthcare system. METHODS: The Informatics Patient Safety Office of the Veterans Health Administration (VA) maintains a non-punitive, voluntary reporting system to collect and investigate EHR-related safety concerns (ie, adverse events, potential events, and near misses). We analyzed completed investigations using an eight-dimension sociotechnical conceptual model that accounted for both technical and non-technical dimensions of safety. Using the framework analysis approach to qualitative data, we identified emergent and recurring safety concerns common to multiple reports. RESULTS: We extracted 100 consecutive, unique, closed investigations between August 2009 and May 2013 from 344 reported incidents. Seventy-four involved unsafe technology and 25 involved unsafe use of technology. A majority (70%) involved two or more model dimensions. Most often, non-technical dimensions such as workflow, policies, and personnel interacted in a complex fashion with technical dimensions such as software/hardware, content, and user interface to produce safety concerns. Most (94%) safety concerns related to either unmet data-display needs in the EHR (ie, displayed information available to the end user failed to reduce uncertainty or led to increased potential for patient harm), software upgrades or modifications, data transmission between components of the EHR, or 'hidden dependencies' within the EHR. DISCUSSION: EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after 'go-live' and despite the sophisticated EHR infrastructure represented in our data source. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. CONCLUSIONS: Because EHR-related safety concerns have complex sociotechnical origins, institutions with long-standing as well as recent EHR implementations should build a robust infrastructure to monitor and learn from them.

The efficacy of a repeated infiltration in prolonging duration of pulpal anesthesia in maxillary lateral incisors.

BACKGROUND: Previous studies have shown declining rates of pulpal anesthesia over 60-minute periods in patients who have received 1.8 milliliters of 2 percent lidocaine with 1:100,000 epinephrine in the maxillary lateral incisor. METHODS: The authors conducted a prospective, randomized, single-blind, crossover study comparing the degree of pulpal anesthesia obtained in 40 adult subjects with two sets of maxillary lateral incisor infiltrations, given in two separate appointments: an initial infiltration of 1.8 mL of 2 percent lidocaine with 1:100,000 epinephrine plus a repeated infiltration of the same anesthetic and dose given 30 minutes after the initial infiltration, and an initial infiltration of 1.8 mL of 2 percent lidocaine with 1:100,000 epinephrine plus a mock repeated infiltration given 30 minutes after the initial infiltration. The authors used an electric pulp tester to test the lateral incisor for anesthesia in two-minute cycles for 90 minutes after the injection. RESULTS: The repeated infiltration improved pulpal anesthesia significantly in the maxillary lateral incisor in the period from 37 through 90 minutes postinjection. CONCLUSION AND CLINICAL IMPLICATIONS: A repeated infiltration of 1.8 mL of 2 percent lidocaine with 1:100,000 epinephrine given 30 minutes after the initial infiltration significantly improved the duration of pulpal anesthesia in the maxillary lateral incisor.

The importance of perspective: evaluation of hospice care from multiple stakeholders.

The literature on hospice care and palliative medicine lacks a focus on the combined and concurrent assessment of services. This deficiency is problematic because research findings are then limited in their scope and applicability to particular stakeholder groups. The current study used the perspective of 72 participants and service delivery personnel of a home-based hospice program to address this perceived problem and limitation in the literature through a program evaluation of the multiple perspectives on a single hospice organization. Interviews were analyzed by stakeholder group and then across stakeholder groups to extract themes. Results include a description of the quality of service delivery and participant satisfaction, areas of current weakness, and ideas for potential growth and development for the program. Findings from this study are compared with previous research on hospice care and the implications of the results to the provision and continued development of hospice care are discussed.

Sexual-moral attitudes, love styles, and mate selection.

Students at a southwestern university were surveyed to test the interrelations of three constructs: sexual-moral attitudes, love styles, and attraction criteria. Following the procedures of the National Health and Social Life Survey, from which the sexual-moral attitude items were obtained, we conducted a cluster analysis to create attitudinal groupings. We obtained four clusters representing various nuances of liberalism and conservatism. When compared on love styles, the clusters differed primarily on ludus and pragma. Not only did some of the liberal clusters differ from some of the conservative ones on love styles, but there were also some differences within liberalism and within conservatism. Cluster differences also emerged on the attraction criteria.

Research in long-term care: issues, dilemmas, and challenges from the public purchaser's perspective.

Expenditures for long-term care for older Americans are sizable and likely to increase as the population ages. As the largest purchaser of health care for this group of citizens, the Centers for Medicare & Medicaid Services (CMS) is working to improve the quality of the long-term care services it purchases through quality monitoring and enforcement, providing information to beneficiaries about quality of care and enhancing resources to improve quality. Although CMS has used the best scientific information available to inform the planning of quality initiative projects, there are a number of issues, dilemmas, and challenges for which the research base is insufficient to fully answer programmatic needs. In many instances, research needs in the long-term care setting differ substantially from those in acute care. Using the Nursing Home Quality Initiative as an example, this article presents a descriptive, conceptual discussion of strategic issues and a summary of research that would be valuable in informing critical areas of decision-making in quality and outcomes research over the next decade. The issues, dilemmas, and challenges discussed are grouped into 5 categories: measurement methods and tools, uses of quality data, organizational and cultural factors, information and informatics, and impact evaluation and research.

Alendronate reduces the risk of multiple symptomatic fractures: results from the fracture intervention trial.

OBJECTIVES: To evaluate the effect of alendronate on the occurrence rate of multiple svmptomatic fractures and on the risk of multiple symptomatic fractures (likelihood of having more than one fracture diagnosed because of the symptoms the fractures caused over the study period) among women with osteoporosis. DESIGN: Primary analysis of data from a randomized, placebo-controlled, double-blind trial. SETTING: Eleven community-based clinical research centers. PARTICIPANTS: Subset of women enrolled in the Fracture Intervention Trial: aged 55 to 81 and having at least one morphometric vertebral fracture at baseline (n=2,027) or having no vertebral fracture but meeting prevailing World Health Organization bone mineral density criteria for osteoporosis (T-score < or =2.5 at the femoral neck)(n = 1,631). INTERVENTION: All participants reporting calcium intake of 1,000 mg/day or less received a supplement of 500 mg calcium and 250 IU cholecalciferol. Participants were randomly assigned to placebo or alendronate sodium (5 mg/day for 2 years and 10 mg/day for the remainder of the study). Average total follow-up was 4.3 years. MEASUREMENTS: Symptomatic fractures were diagnosed by personal physicians and confirmed by review of radiological data by an expert committee blinded to treatment assignments. RESULTS: Eighty-six of 1,817 women receiving placebo experienced multiple symptomatic fractures during the follow-up period, compared with 51 of 1,841 receiving alendronate. Reduction of risk for multiple symptomatic fractures combined was 42% (relative risk (RR) = 0.58, 95% confidence interval (CI) = 0.41, 0.81) and for multiple symptomatic vertebral fractures was 84% (RR = 0.16,95% Cl = 0.05, 0.42). Cumulative incidence curves showed divergence after as little as 3 months of treatment, with a statistically significant (P = .044) reduction at 6 months for multiple symptomatic vertebral fractures. When all fractures over the follow-up period were included, the occurrence rates of all symptomatic fractures and symptomatic vertebral fractures were 34% and 63% lower, respectively, with alendronate than with placebo. These reductions were sustained during the follow-up period. All reductions in risk were consistent across predefined subgroups: age (<75 vs > or =75), morphometric vertebral fracture(present vs absent), prior clinical fracture since age 45 (yes vs no), and whether the subject had fallen in the 12 months before randomization. CONCLUSIONS: These data demonstrate that treatment with alendronate reduces the risk of multiple symptomatic fractures during a treatment period averaging 4.3 years. The reductions were consistent across prespecified sub-groups. This effect is evident early in treatment and is sustained.