The Value and Validity of Self-Reported Survey Data on the Rape Experiences of College Students.

Self-reported survey data on the extent and nature of rape and sexual assault experienced by a population represent an important source of information because these crimes often go unreported, and are thus undercounted in law enforcement or other official statistics. This article compares Campus Climate Survey Validation Study (CCSVS) data to Clery Act data in an effort to (1) assess the validity of the CCSVS data and the Clery Act data based on the extent to which they corroborate one another, and (2) estimate the extent to which Clery Act data potentially underestimate the true incidence of rape. The results help to establish the extent to which self-report surveys on sexual victimization are needed to understand the magnitude of the problem among a given population.

Dietary Choline Supplements, but Not Eggs, Raise Fasting TMAO Levels in Participants with Normal Renal Function: A Randomized Clinical Trial.

BACKGROUND: Choline is a dietary precursor to the gut microbial generation of the prothrombotic and proatherogenic metabolite trimethylamine-N-oxide (TMAO). Eggs are rich in choline, yet the impact of habitual egg consumption on TMAO levels and platelet function in human subjects remains unclear. METHODS: Healthy volunteers (41% male, 81% Caucasian, median age 28 years) with normal renal function (estimated glomerular filtration rate >60) were recruited and assigned to 1 of 5 daily interventions for 4 weeks: 1) hardboiled eggs (n = 18); 2) choline bitartrate supplements (n = 20); 3) hardboiled eggs + choline bitartrate supplements (n = 16); 4) egg whites + choline bitartrate supplements (n = 18); 5) phosphatidylcholine supplements (n = 10). Fasting blood and urine samples were collected for quantification of TMAO, its precursors, and platelet aggregometry. RESULTS: Participants' plasma TMAO levels increased significantly in all 3 intervention arms containing choline bitartrate (all P < .0001), but daily ingestion of 4 large eggs (P = .28) or phosphatidylcholine supplements (P = .27) failed to increase plasma TMAO levels. Platelet reactivity also significantly increased in the 3 intervention arms containing choline bitartrate (all P < .01), but not with eggs (P = .10) or phosphatidylcholine supplements (P = .79). CONCLUSIONS: Despite high choline content in egg yolks, healthy participants consuming 4 eggs daily showed no significant increase in TMAO or platelet reactivity. However, choline bitartrate supplements providing comparable total choline raised both TMAO and platelet reactivity, demonstrating that the form and source of dietary choline differentially contributes to systemic TMAO levels and platelet responsiveness.

Treatment of Lower Extremity Fractures in Chronic Spinal Cord Injury: A Systematic Review of the Literature.

OBJECTIVE: To review the literature regarding outcomes of surgical and nonsurgical management of lower extremity (LE) fractures in chronic spinal cord injury (SCI). TYPE: Systematic review. LITERATURE SURVEY: Medline (PubMed), Embase, Cochrane Database of Systemic Reviews, Cochrane Central, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov, International Clinical Trials Registry Platform, and International Standard Randomized Controlled Trials were searched from January 1, 1966, to March 1, 2019. METHODOLOGY: Search was restricted to English language and adults (age ≥ 18 yr). Titles and abstracts were reviewed for relevance to study topics for inclusion. Case reports, reviews, non-SCI population studies, and studies examining fractures at the time of acute SCI were excluded. References of included articles from the original search and task force and external submissions yielded two additional articles that were included in the review after voting by task force members. Data extraction was performed by four task force members using a data extraction form, glossary, and instructions created in Microsoft Excel. Quality assessment was performed by three methodologists using prespecified criteria. SYNTHESIS: Twenty-three articles were included. Use of surgery to treat LE fractures in chronic SCI has increased, though nonoperative management was still more frequently reported. Regardless of type of management, amputations, nonunion/malunion, and pressure injuries were among the most commonly reported complications. Functional and quality of life outcomes were less frequently reported. CONCLUSIONS: There is insufficient evidence to support operative versus nonoperative management as best practice for management of LE fracture of SCI. Existing literature was limited by small sample sizes, lack of randomization or matched study designs, significant heterogeneity in populations and treatment strategies studied, and variability in defining and reporting outcomes of interest. The field would benefit from future research to address study design issues and standardization of outcome reporting to facilitate comparison of outcomes of operative versus nonoperative management.

Association Between Traumatic Brain Injury and Dementia in Veterans: A Rapid Systematic Review.

OBJECTIVE: To systematically review the prevalence of dementia in Veterans versus civilians and the association between previous traumatic brain injuries (TBIs) and the risk and timing of dementia onset in Veterans. DESIGN: We systematically searched MEDLINE, PsycINFO, and Cochrane Central Register of Controlled Trials from database inception to October 2018. One reviewer assessed articles for inclusion, evaluated study quality, graded strength of evidence, and extracted data, with second reviewer checking. RESULTS: Forty articles were included, among which 10 presented the best evidence. Evidence suggests that dementia rates are likely similar between Veterans and civilians (10.7% vs 8.8%-11.6%, respectively). Dementia prevalence is likely higher in those with TBI (6%-16%) than in those without (3%-10%), with a possible dose-response relationship between the two. There may also be an association between TBI and early-onset dementia, although this evidence has important limitations. No studies evaluated whether dementia prevalence varied on the basis of combat deployment history or era of conflict. CONCLUSION: Dementia prevalence is likely similar in Veteran and civilian populations, and the risk of dementia is likely increased by TBI. To inform development of screening, prevention, and rehabilitation efforts, research is still needed addressing the mechanism of association and timing of dementia onset. PROTOCOL: PROSPERO; CRD42018107926.

Disclosure of Adverse Events: A Guide for Clinicians.

INTRODUCTION: Children's Hospitals' Solutions for Patient Safety (SPS) acknowledged a recommendation from the American Academy of Pediatrics to develop education programs on the communication of adverse events with patients and families. SPS set out to create a guide that would outline a standardized disclosure process and provide a training curriculum and tools so that providers would feel better prepared to have effective disclosure conversations. METHODS: SPS disclosure work began with the development of a project team made up of 9 network hospitals. The team utilized key driver diagrams and process maps to show the relationship between the project aims, key drivers, and specific interventions. The team developed a training curriculum, guide, and tools for each area of improvement. To ensure these were effective, they were tested using case studies and plan-do-study-act cycles. RESULTS: One of the cohort hospitals piloted the curriculum and tools, training 48 physicians, nurses, executives, and other allied health professionals. Pretest to posttest scores improved from an average of 82.7% to 90.2%. Survey feedback was favorable with 100% of respondents noting that they strongly agree or agree that attending this educational activity increased or improved their competency, performance, and patient outcomes. CONCLUSIONS: Initial testing suggests that the developed curriculum is empowering for frontline clinicians. Materials are available in an electronic format on the SPS external website. As member hospitals implement these materials, they will be evaluating learner satisfaction and provider usage. SPS will seek out feedback from these hospitals to further develop the materials and support clinicians.

"Implementation Is so Difficult": Survey of National Learning Health System Decision-makers Identifies Need For Implementation Information in Evidence Reviews.

BACKGROUND: Evidence use within learning health care systems can improve patient health outcomes. Embedded in the Veterans Health Administration (VHA) since 2007, the Veterans Affairs Evidence Synthesis Program (ESP) provides tailored evidence synthesis services to support VHA's learning health care system goals. As part of the ESP's ongoing quality improvement efforts, we have been surveying our users since 2016. METHODS: We reviewed data from a survey of end-users received between September 5, 2016, and June 10, 2019. The survey assessed: (1) nature of decision-making needs; (2) actions resulting from the report's findings; (3) implementation timeframe; and (4) overall perception of report content. RESULTS: Feedback was received from 66 of the 138 operational partners requesting ESP products during the fiscal year 2015 through 2018. Requests commonly informed clinical guidance (58%), identified future research needs (58%), and determined VHA-specific implementation strategy (47%). A total of 91% of responders used reports, typically within 3 months after completion (82%). Use was typically for VHA publications and/or presentations to inform VHA policy or guidance (26%), to inform intervention/strategy adoption decisions (23%) and for medical device and therapy procurement decisions (21%). Over half (53%) of respondents indicated that it would be useful for ESP reports to include more guidance on implementing findings. CONCLUSION: Our survey of learning health system decision-makers' actual patterns and timing of evidence use provides valuable new information that can further support development of other health system and evidence producer partnerships and identifies key needs for better supporting health systems' uptake of evidence.

A Comprehensive Review of Quality of Life Surveys for Trauma-Affected Communities.

Research shows that exposure to community and domestic violence leads to psychological trauma from childhood through adulthood, which can lead to poor health and early death. A team of health information management (HIM) professionals reviewed existing surveys to determine their suitability for assessing the quality of life (QoL) of people in trauma-affected communities (TACs). Keywords were used to search for papers describing validated QoL surveys. The obtained papers were screened, reviewed, and summarized to determine if they include the aspects needed for assessing QoL in TACs. Survey items from 20 surveys were identified as relevant to this study. Most of these 20 surveys cover one or two domains of QoL, and none of them were specifically designed for people in TACs. Therefore, it is necessary to develop a psychometrically sound assessment tool to quantify the levels of trauma, resilience, and well-being in TACs. HIM professionals have the required skills for this task.

Reducing Serious Safety Events and Priority Hospital-Acquired Conditions in a Pediatric Hospital with the Implementation of a Patient Safety Program.

BACKGROUND: A freestanding children's hospital evaluated the impact of a patient safety program on serious safety events (SSEs) and hospital-acquired conditions (HACs). METHODS: The No Harm Patient Safety Program was developed throughout the organization using a multifaceted approach that included safety moments, leadership rounding, cause analysis changes, event reporting enhancements, error prevention training, leadership training, identifying priority HACs, Eye on Safety Campaign, and safety coaches. The organization set strategic goals for improvement of SSEs and priority HACs. RESULTS: The rate of SSEs decreased from 0.19 in 2014 to 0.09 in 2015. The rate significantly declined from 2015 to 2016 to a rate of 0.00, for a rate difference of -0.00009 (95% confidence interval [CI]: -0.00016, -0.00002; p = 0.012). The organization reached two years without an SSE in July 2017. The central line-associated bloodstream infection rate significantly declined from 2.8 per 1,000 line-days in 2015 to 1.6 in 2016, for a difference of -0.00118 (95% CI: -0.002270, -0.00008; p = 0.036). Surgical site infection rates declined from a 2015 rate of 3.8 infections per 100 procedures to a 2016 rate of 2.6 (p = 0.2962), and catheter-associated urinary tract infection rates declined from a 2015 rate of 2.7 per 1,000 catheter-days to a 2016 rate of 1.4 (p = 0.2770). CONCLUSION: The No Harm Patient Safety Program was interwoven into the organization's strategic mission and values, and key messaging was used to purposefully tie the many interventions being implemented back to it. These interventions were associated with improvements in patient safety outcomes.

Rapid evidence review of the comparative effectiveness, harms, and cost-effectiveness of pharmacogenomics-guided antidepressant treatment versus usual care for major depressive disorder.

OBJECTIVE: This study aims to conduct an evidence review of the effectiveness, harms, and cost-effectiveness of pharmacogenomics-guided antidepressant treatment for major depressive disorder. METHODS: We searched MEDLINE®, the Cochrane Central Registry of Controlled Trials, and PsycINFO through February 2017. We used prespecified criteria to select studies, abstract data, and rate internal validity and strength of the evidence (PROSPERO number CRD42016036358). RESULTS: We included two randomized trials (RCT), five controlled cohort studies, and six modeling studies of mostly women in their mid-40s with few comorbidities. CNSDose (ABCB1, ABCC1, CYP2C19, CYP2D6, UGT1A1) is the only pharmacogenomics test that significantly improved remission (one additional remitting patient in 12 weeks per three genotyped, 95% CI 1.7 to 3.5) and reduced intolerability in an RCT. ABCB1 genotyping leads to one additional remitting patient in 5 weeks per three genotyped (95% CI 3 to 20), but tolerability was not reported. In an RCT, GeneSight (CYP2D6, CYPC19, CYP1A2, SLC6A4, HTR2A) did not statistically significantly improve remission, and evidence is inconclusive about its tolerability. Evidence is generally low strength because RCTs were few and underpowered. Cost-effectiveness is unclear due to lack of directly observed cost-effectiveness outcomes. We found no studies that evaluated whether pharmacogenomics shortens time to optimal treatment, whether improvements were due to switches to genetically congruent medication, or whether effectiveness varies based on test and patient characteristics. CONCLUSIONS: Certain pharmacogenomics tools show promise of improving short-term remission rates in women in their mid-40s with few comorbidities. But, important evidence limitations preclude recommending their widespread use and indicate a need for further research.

The predictive validity of quality of evidence grades for the stability of effect estimates was low: a meta-epidemiological study.

OBJECTIVE: To determine the predictive validity of the U.S. Evidence-based Practice Center (EPC) approach to GRADE (Grading of Recommendations Assessment, Development and Evaluation). STUDY DESIGN AND SETTING: Based on Cochrane reports with outcomes graded as high quality of evidence (QOE), we prepared 160 documents which represented different levels of QOE. Professional systematic reviewers dually graded the QOE. For each document, we determined whether estimates were concordant with high QOE estimates of the Cochrane reports. We compared the observed proportion of concordant estimates with the expected proportion from an international survey. To determine the predictive validity, we used the Hosmer-Lemeshow test to assess calibration and the C (concordance) index to assess discrimination. RESULTS: The predictive validity of the EPC approach to GRADE was limited. Estimates graded as high QOE were less likely, estimates graded as low or insufficient QOE more likely to remain stable than expected. The EPC approach to GRADE could not reliably predict the likelihood that individual bodies of evidence remain stable as new evidence becomes available. C-indices ranged between 0.56 (95% CI, 0.47 to 0.66) and 0.58 (95% CI, 0.50 to 0.67) indicating a low discriminatory ability. CONCLUSION: The limited predictive validity of the EPC approach to GRADE seems to reflect a mismatch between expected and observed changes in treatment effects as bodies of evidence advance from insufficient to high QOE.

A case study of pooled-studies publications indicated potential for both valuable information and bias.

OBJECTIVES: Pooled-studies publications (PSPs) present statistical analyses of multiple randomized controlled trials without a systematic literature search or critical appraisal. We explored the characteristics of PSPs and their potential impact on a systematic review (SR). STUDY DESIGN AND SETTING: We systematically evaluated PSPs excluded from an SR of second-generation antidepressants. We analyzed their basic characteristics, risk of bias, and the effect of new data on review conclusions. RESULTS: We identified 57 PSPs containing a median of five trials (range, 2-11) and 1,233 patients (range, 117-2,919). Ninety-six percent of PSPs were industry funded, and 49% of PSPs contained unpublished data. The median number of citations for PSPs was 29 (range, 0-549). Only 7% planned pooling a priori, and 19% combined trials with identical protocols. Fifty-nine percent of PSPs eligible for general efficacy provided no new data. For some subgroups and accompanying symptoms (e.g., anxiety, insomnia, melancholia, fatigue, sex, and race), more than 30% of PSPs presented entirely new data or data that could alter the strength of the evidence available in the SR. CONCLUSION: In this case study, PSPs provided new information on subgroups and secondary outcomes; however, guidance for reviewers and development of a system to assess their susceptibility to bias are required.

Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is used as a bone graft substitute in spinal fusion, which unites (fuses) bones in the spine. The accuracy and completeness of journal publications of industry-sponsored trials on the effectiveness and harms of rhBMP-2 has been called into question. PURPOSE: To independently assess the effectiveness and harms of rhBMP-2 in spinal fusion and reporting bias in industry-sponsored journal publications. DATA SOURCES: Individual-patient data (IPD) from 17 industry-sponsored studies; related internal documents; and searches of MEDLINE (1996 to August 2012), other databases, and reference lists. STUDY SELECTION: Randomized, controlled trials (RCTs) and cohort studies of rhBMP-2 versus any control and uncontrolled studies of harms. DATA EXTRACTION: Effectiveness outcomes in IPD were recalculated using consistent definitions. Study characteristics and results were abstracted by 1 investigator and confirmed by another. Two investigators independently assessed quality using predefined criteria. DATA SYNTHESIS: Thirteen RCTs and 31 cohort studies were included. For lumbar spine fusion, rhBMP-2 and iliac crest bone graft were similar in overall success, fusion, and other effectiveness measures and in risk for any adverse event, although rates were high across interventions (77% to 93% at 24 months from surgery). For anterior lumbar interbody fusion, rhBMP-2 was associated with nonsignificantly increased risk for retrograde ejaculation and urogenital problems. For anterior cervical spine fusion, rhBMP-2 was associated with increased risk for wound complications and dysphagia. At 24 months, the cancer risk was increased with rhBMP-2 (risk ratio, 3.45 [95% CI, 1.98 to 6.00]), but event rates were low and cancer was heterogeneous. Early journal publications misrepresented the effectiveness and harms through selective reporting, duplicate publication, and underreporting. LIMITATIONS: Outcome assessment was not blinded, and ascertainment of harms in trials was poor. No trials were truly independent of industry sponsorship. CONCLUSION: In spinal fusion, rhBMP-2 has no proven clinical advantage over bone graft and may be associated with important harms, making it difficult to identify clear indications for rhBMP-2. Earlier disclosure of all relevant data would have better informed clinicians and the public than the initial published trial reports did. PRIMARY FUNDING SOURCE: Yale University and Medtronic.

Does the use of an assistive device by nurses impact peripheral intravenous catheter insertion success in children?

Peripheral intravenous (PIV) access is a common and essential component for the medical management of the hospitalized child. Delayed or failed PIV insertion can increase the risk for complications from delayed intravenous treatment. Repetitive PIV insertion attempts can cause psychological trauma to the child and decrease family satisfaction. This study examined the success of two vein visualization assistive devices in aiding PIV insertions performed by pediatric medical-surgical nurses. During the 11-month investigation period, PIV insertion success was significantly higher when no assistive device was used compared to assisted methods. Implications for practice and further research are discussed.

A fluorescence polarization assay for identifying ligands that bind to vascular endothelial growth factor.

Vascular endothelial growth factor (VEGF) is a homodimeric proangiogenic protein that induces endothelial cell migration and proliferation primarily through interactions with its major receptors, VEGFR-1 and VEGFR-2. Inhibitors of one or both of these VEGF-receptor interactions could be beneficial as therapeutics for diseases caused by dysfunctional angiogenesis (e.g., cancer). Others have reported small peptides that bind to the VEGF dimer at surface regions that are recognized by the receptors. Here we report the development of a fluorescence polarization assay based on the binding to VEGF of a derivative of one of these peptides that has been labeled with BODIPY-tetramethylrhodamine (BODIPY(TMR)). This 384-well format assay is tolerant to dimethyl sulfoxide (DMSO, up to 4% [v/v]) and has a Z' factor of 0.76, making it useful for identifying molecules that associate with the receptor-binding surface of the VEGF dimer.

H/D exchange- and mass spectrometry-based strategy for the thermodynamic analysis of protein-ligand binding.

The equilibrium unfolding properties of four model protein systems were characterized using SUPREX (stability of unpurified proteins from rates of H/D exchange). SUPREX is an H/D exchange- and mass spectrometry-based technique for measuring the free energy (DeltaGf) and m-value (deltaDeltaGf/delta[denaturant]) associated with the folding/unfolding reaction of a protein. The model proteins in this study (calmodulin, carbonic anhydrase II, RmlB, Bcl-xL) were chosen to test the applicability of SUPREX to the thermodynamic analysis of larger (> approximately 15 kDa) or multidomain proteins. In the absence of ligand, DeltaGf and m-values for these proteins could not be evaluated using the conventional data acquisition and analysis methods previously established for SUPREX. However, ligand-bound forms of the proteins were amenable to conventional SUPREX analyses, and it was possible to evaluate reasonably accurate and precise binding free energies of selected ligands. In some cases, protein-ligand dissociation constants (Kd values) could also be ascertained. The SUPREX-derived binding free energies and Kd values evaluated here were in good agreement with those reported on the same complexes using other techniques.