Obstetric Anesthesia Procedure-Based Workload and Facility Utilization of Society of Obstetric Anesthesia and Perinatology Centers of Excellence Designated Institutions.

BACKGROUND: Optimal workload and staffing for obstetric anesthesia services have yet to be determined. We surveyed Society of Obstetric Anesthesia and Perinatology (SOAP) Centers of Excellence (COE) for Obstetric Anesthesia Care institutions to evaluate procedure-based obstetric anesthesia workload and facility use. METHODS: After institutional review board (IRB) exemption, an online survey instrument (REDCap) was sent by email (1 initial and 2 reminders) to all SOAP COEs. Survey data included the number of deliveries, cesarean delivery rate, neuraxial labor analgesia rate, the number of labor and operating rooms, and the number of in-house and backup obstetric anesthesia providers. Obstetric anesthesia activity was estimated using a time-based workload ratio per provider (Stanford Work Index, 1.0 = clinically working every minute of every hour on duty) during weekday, weeknight, and weekend shifts. We compared workload between academic and nonacademic centers and correlated operating and labor rooms with cesarean and vaginal delivery volume. RESULTS: Fifty-one of 53 surveys were returned (96% response rate). Data from 33 academic and 14 nonacademic US institutions were analyzed. For academic centers, median Stanford Work Index for all staff (included trainees and Certified Registered Nurse Anesthetists) was 0.20 (weekday) and 0.19 (weeknight and weekends); nonacademic centers were 0.33 (weekday, P < .001 versus academic), 0.23 (weeknight, P = .009 versus academic), and 0.23 (weekends, P = .03 versus academic practices). Attending-only Stanford Work Indices were similar between academic and nonacademic centers. Total number of rooms on the obstetric suite (operating, labor, or triage room) was strongly correlated with delivery volume ( R2 = 0.55). CONCLUSIONS: The results outline staffing procedure-based workload ratios and facility utilization at SOAP COEs in the United States. These data can be used by other institutions that provide obstetric anesthesia services to guide their obstetric anesthesia staffing. The importance of considering the workload associated with different shifts and between academic and nonacademic centers is also highlighted. The results show that approximately one-third of an obstetric anesthesiologist's workload is spent on performing procedures. We did not, however, measure the other tasks anesthesiologists practice as peripartum physicians (eg, managing critically ill parturients, doing pre- and postprocedural evaluations, or performing emergent and unexpected procedures), and future studies are required to determine the time required to perform these tasks. Studies to determine the optimal staffing models to handle workload fluctuations and improve outcomes are also required.

Direct Mail Recruitment to a Potential Participant Registry.

Recruitment registries are novel tools to accelerate Alzheimer disease research accrual. Optimal methods to populate such registries remain largely unstudied. We sent postcards with 3 unique taglines (Alzheimer's Prevention Research, brain health research, general research) to 100,000 local residents aged 50 years and older to assess the effectiveness of recruiting to an online recruitment registry by mail. The postcard campaign recruited 273 new registry enrollees (0.27% overall response rate). Neither the response rate nor the demographic characteristics of recruited participants differed by the postcard tagline. These results suggest that direct mail may not be the most cost-effective approach to recruit participants to online registries.

Using Direct-to-Consumer Genetic Testing Results to Accelerate Alzheimer Disease Clinical Trial Recruitment.

INTRODUCTION: The apolipoprotein E (APOE) gene is the strongest known genetic risk factor for sporadic Alzheimer disease (AD). APOE can be used as an enrichment strategy or inclusion criterion for AD prevention trials. Personal genomics companies market direct-to-consumer (DTC) genetic tests, including APOE. We assessed DTC APOE testing usage among enrollees of the University of California Irvine Consent-to-Contact Registry, an online recruitment registry, and attitudes toward using this information in clinical trial recruitment. METHODS: We emailed links to an electronic survey to registry enrollees age 50 years or older. We assessed participants' use of DTC services, willingness to learn APOE status, and willingness to share genetic information. Logistic regression models assessed relationships between DTC testing usage and demographic characteristics, and with willingness to share results to assist trial recruitment. RESULTS: Among 1312 responders (57% response rate), few (7%) had used DTC testing for APOE. Non-Hispanic Asian enrollees were 93% less likely to have used DTC testing, compared with non-Hispanic Whites [95% confidence interval: (0.01, 0.67)]. Willingness to share APOE information for study recruitment was >90% for both users and nonusers. CONCLUSIONS: Matching participants to trials on the basis of DTC APOE information may be an effective way to streamline AD prevention trial recruitment.

Continuous wound infusion catheter as part of a multimodal analgesia regimen for post-Caesarean delivery pain: a quality improvement impact study.

Background: The role of continuous wound infusion catheters as part of a multimodal analgesia strategy after Caesarean delivery is unclear. We introduced continuous wound infusion catheters to our multimodal analgesia regimen to evaluate the impact on analgesic outcomes after Caesarean delivery. Methods: After institutional review board (IRB) approval, a 4-month practice change was instituted as a quality improvement initiative. In addition to multimodal analgesia, continuous wound infusion catheters for up to 3 days were offered on alternate weeks for all women undergoing Caesarean deliveries. The primary outcome was postoperative in-hospital opioid consumption. Secondary outcomes were static and dynamic pain scores at 24 and 72 h, time until first analgesic request, opioid-related side-effects, length of stay, satisfaction (0-100%), and continuous wound infusion catheter-related complications. Results: All women scheduled for Caesarean delivery (n=139) in the 4-month period were included in the analysis, with 70 women receiving continuous wound infusion catheters, and 69 in the control group. Opioid consumption (continuous wound infusion catheter group 11.3 [7.5-61.9] mg morphine equivalents vs control group 30.0 [11.3-48.8] mg morphine equivalents), pain scores (except 24 h resting pain scores which were higher in the control group 2 [1-3] vs 1.5 [0-3] in the continous wound infusion catheters group; P=0.05), side-effects, length of stay, and complications were similar between groups. Satisfaction scores at 24 h were higher with continuous wound infusion catheters (100% [91-100%] vs 90% [86-100%]; P=0.003) with no differences at 72 h. One patient demonstrated symptoms of systemic local anaesthetic toxicity which resolved without significant harm. Conclusions: The addition of continuous wound infusion catheters to a multimodal analgesia regimen for post-Caesarean delivery pain management demonstrated minimal clinically significant analgesic benefits. Future studies are needed to explore the use of continuous wound infusion catheters in populations that may benefit most from this intervention.

Effect of Aducanumab Approval on Willingness to Participate in Preclinical Alzheimer's Disease Trials.

BACKGROUND: Clinical trials now test promising therapies in the preclinical stages of Alzheimer's disease (AD). Participant willingness to enroll in different types of preclinical AD trials is understudied and whether the FDA approval of aducanumab affected these attitudes is unknown. OBJECTIVE: To evaluate preferences toward three preclinical AD trial scenarios and whether the FDA approval of aducanumab changed willingness to participate among potential trial participants. METHODS: Through an electronic survey, we asked enrollees in a recruitment registry age 50-79 to rate their willingness (using a 6-point Likert scale) to enroll in three hypothetical preclinical AD trial scenarios: an in-clinic infused monoclonal antibody intervention, a home-infused monoclonal antibody intervention, and an oral BACE inhibitor intervention. We administered the survey before and after the FDA approval of aducanumab. We used a generalized estimating equation model to assess group differences in preference for the trial scenarios. We used a paired t-test to determine if willingness to participate (using total willingness across three scenarios as the outcome) changed after the FDA decision. RESULTS: At baseline, the mean participant willingness was highest in the in-clinic infusion scenario. There was no significant change in willingness to participate, overall, after the FDA decision. Participants who were independently aware of the FDA's decision (prior to the second survey) demonstrated reduced willingness to participate; participants unaware of the FDA decision demonstrated no change. CONCLUSION: Willingness to participate in preclinical AD trials may have been negatively affected by the FDA's decision to approve aducanumab among those aware of the decision.

Self-reported information needs of anesthesia residency applicants and analysis of applicant-related web sites resources at 131 United States training programs.

BACKGROUND: Despite the use of web-based information resources by both anesthesia departments and applicants, little research has been done to assess these resources and determine whether they are meeting applicant needs. Evidence is needed to guide anesthesia informatics research in developing high-quality anesthesia residency program Web sites (ARPWs). METHODS: We used an anonymous web-based program (SurveyMonkey, Portland, OR) to distribute a survey investigating the information needs and perceived usefulness of ARPWs to all 572 Stanford anesthesia residency program applicants. A quantitative scoring system was then created to assess the quality of ARPWs in meeting the information needs of these applicants. Two researchers independently analyzed all 131 ARPWs in the United States to determine whether the ARPWs met the needs of applicants based on the scoring system. Finally, a qualitative assessment of the overall user experience of ARPWs was developed to account for the subjective elements of the Web site's presentation. RESULTS: Ninety-eight percent of respondents reported having used ARPWs during the application process. Fifty-six percent reported first visiting the Stanford ARPW when deciding whether to apply to Stanford's anesthesia residency program. Multimedia and Web 2.0 technologies were "very" or "most" useful in "learning intangible aspects of a program, like how happy people are" (42% multimedia and Web 2.0 versus 14% text and photos). ARPWs, on average, contained only 46% of the content items identified as important by applicants. The average (SD) quality scores among all ARPWs was 2.06 (0.59) of 4.0 maximum points. The mean overall qualitative score for all 131 ARPWs was 4.97 (1.92) of 10 points. Only 2% of applicants indicated that the majority (75%-100%) of Web sites they visited provided a complete experience. CONCLUSION: Anesthesia residency applicants rely heavily on ARPWs to research programs, prepare for interviews, and formulate a rank list. Anesthesia departments can improve their ARPWs by including information such as total hours worked and work hours by rotation (missing in 96% and 97% of ARPWs) and providing a valid web address on the Fellowship and Residency Electronic Interactive Database Access System (FREIDA) (missing in 28% of ARPWs).

Racial and ethnic differences in older adults' willingness to be contacted about Alzheimer's disease research participation.

INTRODUCTION: We sought to examine the association of race/ethnicity with willingness to engage in studies that involve procedures typical of Alzheimer's disease (AD) clinical trials and determine whether any observed differences could be explained by research attitudes. METHODS: We studied 2749 adults aged ≥50 years who enrolled in a community-based recruitment registry. RESULTS: Compared to non-Hispanic (NH) whites (n = 2393, 87%), Hispanics (n = 191, 7%), NH Asians (n = 129, 5%) and NH blacks (n = 36, 1%) were 44%, 46%, and 64% less willing, respectively, to be contacted for studies that have requirements typical of AD prevention trials, namely: cognitive testing, brain imaging, blood draws, and investigational medications. Mediation by research attitudes was explored, but did not explain the observed differences. DISCUSSION: Our findings suggest that ethnoracial minorities are less willing to engage in studies that are typical of AD prevention trials. Future work should focus on understanding the factors that drive these differences.

Education and Message Framing Increase Willingness to Undergo Research Lumbar Puncture: A Randomized Controlled Trial.

Reluctance to undergo lumbar puncture (LP) is a barrier to neurological disease biomarker research. We assessed whether an educational intervention increased willingness to consider research LP and whether message framing modified intervention effectiveness. We randomly assigned 851 recruitment registry enrollees who had previously indicated they were unwilling to be contacted about studies requiring LP to gain or loss framed video educational interventions describing the procedure and the probability of experiencing adverse events. The gain framed intervention emphasized the proportion of individuals free of adverse events; the loss frame emphasized the proportion experiencing adverse events. The primary outcome for the study was the participant's post-intervention agreement to be contacted about studies requiring LP. Participants were mean (SD) age 60.1 years (15.7), 69% female (n = 591), and mostly college educated and white. Among the 699 participants who completed the study, 43% (95% CI: 0.39, 0.47; n = 301) changed their response to agree to be contacted about studies requiring LP. We estimated that participants randomized to the gain framed intervention had 67% higher odds of changing their response compared to those randomized to the loss frame (Odds Ratio = 1.67; 95% CI: 1.24, 2.26; p < 0.001). A classification and regression tree model identified participants' pre-intervention willingness as the strongest predictor of changing response. Education, in particular education that alerts participants to the probability of not experiencing adverse events, may be an effective tool to increase participation rates in research requiring LP.

All in the mind? Estimating the effect of mental health on health behaviours.

BACKGROUND: Health behaviours and mental illness have been found to be strongly correlated, both across and within individuals. However, establishing the precise nature of this link, particularly in terms of causality and its direction, remains a challenge. Much of the relevant existing research follow an experimental design and focus on measuring how changes in health behaviours affect mental health. OBJECTIVE: The study examines changes in mental health and health behaviours within individuals across time and evaluates the evidence for a causal pathway from psychological distress to risky health behaviours. METHOD: Using a population representative longitudinal survey providing data from Australian households, this study employs a fixed-effects panel model framework to account for unobserved time-invariant individual heterogeneity. An instrumental variable estimation strategy is employed to specifically evaluate the evidence of a causal pathway from psychological distress to risky health behaviours. RESULTS: The results confirm strong within-individual associations between psychological distress and health behaviours. Further evidence supports a causal relationship from psychological distress to health behaviours, though only for men and lifestyle habits. The case for a direct causal pathway is less straightforward when considering dietary habits, and potentially also for women. This lack of clarity suggests at least some of the observed within-individual associations reflect causal effects of psychological distress on risky health behaviours. CONCLUSIONS: Given the substantial burden of disease associated with unhealthy behaviours, further research examining potential causal pathways from mental health to health behaviours should be a priority, as there is the potential to reduce health burden through mental health improvements.

Constructing a Local Potential Participant Registry to Improve Alzheimer's Disease Clinical Research Recruitment.

Potential participant registries are tools to address the challenge of slow recruitment to clinical research. In particular, registries may aid recruitment to secondary prevention clinical trials for Alzheimer's disease (AD), which enroll cognitively normal older individuals meeting specific genetic or biomarker criteria. Evidence of registry effectiveness is sparse, as is guidance on optimal designs or methods of conduct. We report our experiences of developing a novel local potential participant registry that implemented online enrollment and data collection. In the first year of operation, 957 individuals submitted email addresses to the registry, of whom 592 self-reported demographic, family history, and medical data. In addition, registrants provided information related to their interest and willingness to be contacted about studies. Local earned media and community education were the most effective methods of recruitment into the registry. Seventy-six (26%) of 298 registrants contacted about studies in the first year enrolled in those studies. One hundred twenty-nine registrants were invited to enroll in a preclinical AD trial, of whom 25 (18%) screened and 6 were randomized. These results indicate that registries can aid recruitment and provide needed guidance for investigators initiating new local registries.

Attitudes toward Potential Participant Registries.

Difficult participant recruitment is a consistent barrier to successful medical research. Potential participant registries represent an increasingly common intervention to overcome this barrier. A variety of models for registries exist, but few data are available to instruct their design and implementation. To provide such data, we surveyed 110 cognitively normal research participants enrolled in a longitudinal study of aging and dementia. Seventy-four (67%) individuals participated in the study. Most (78%, CI: 0.67, 0.87) participants were likely to enroll in a registry. Willingness to participate was reduced for registries that required enrollment through the Internet using a password (26%, CI: 0.16, 0.36) or through email (38%, CI: 0.27, 0.49). Respondents acknowledged their expectations that researchers share information about their health and risk for disease and their concerns that their data could be shared with for-profit companies. We found no difference in respondent preferences for registries that shared contact information with researchers, compared to honest broker models that take extra precautions to protect registrant confidentiality (28% versus 30%; p = 0.46). Compared to those preferring a shared information model, respondents who preferred the honest broker model or who lacked model preference voiced increased concerns about sharing registrant data, especially with for-profit organizations. These results suggest that the design of potential participant registries may impact the population enrolled, and hence the population that will eventually be enrolled in clinical studies. Investigators operating registries may need to offer particular assurances about data security to maximize registry enrollment but also must carefully manage participant expectations.

Acute opioid withdrawal is associated with increased neural activity in reward-processing centers in healthy men: A functional magnetic resonance imaging study.

BACKGROUND: Opioid analgesics are frequently prescribed for chronic pain. One expected consequence of long-term opioid use is the development of physical dependence. Although previous resting state functional magnetic resonance imaging (fMRI) studies have demonstrated signal changes in reward-associated areas following morphine administration, the effects of acute withdrawal on the human brain have been less well-investigated. In an earlier study by our laboratory, ondansetron was shown to be effective in preventing symptoms associated with opioid withdrawal. The purpose of this current study was to characterize neural activity associated with acute opioid withdrawal and examine whether these changes are modified by ondansetron. METHODS: Ten participants were enrolled in this placebo-controlled, randomized, double-blind, crossover study and attended three acute opioid withdrawal sessions. Participants received either placebo or ondansetron (8Ymg IV) before morphine administration (10Ymg/70Ykg IV). Participants then underwent acute naloxone-precipitated withdrawal during a resting state fMRI scan. Objective and subjective opioid withdrawal symptoms were assessed. RESULTS: Imaging results showed that naloxone-precipitated opioid withdrawal was associated with increased neural activity in several reward processing regions, including the right pregenual cingulate, putamen, and bilateral caudate, and decreased neural activity in networks involved in sensorimotor integration. Ondansetron pretreatment did not have a significant effect on the imaging correlates of opioid withdrawal. CONCLUSIONS: This study presents a preliminary investigation of the regional changes in neural activity during acute opioid withdrawal. The fMRI acute opioid withdrawal model may serve as a tool for studying opioid dependence and withdrawal in human participants.

Endothelin-induced modulation of neuropeptide Y and norepinephrine release from the rat mesenteric bed.

The effect of three endothelin (ET) agonists [ET-1, ET-3, and sarafotoxin (STX6C)] on the nerve stimulation-induced release of norepinephrine (NE) and neuropeptide Y-immunoreactive compounds (NPY-ir) from the perfused mesenteric arterial bed of the rat as well as the effect on perfusion pressure were examined. ET-1, ET-3, and STX6C all produced a significant, concentration-dependent decrease in the evoked release of NPY-ir but had no effect on the release of NE. In contrast, all three ETs potentiated the nerve stimulation-induced increase in perfusion pressure. The inhibition of nerve stimulation-induced NPY-ir release by ET-1 was significantly blocked by the ET(A)/ET(B) antagonist PD-142893 and the ET(B) antagonist RES-701-1 but not by the ET(A) antagonist BQ-123. The potentiation of the nerve stimulation-induced increase in perfusion pressure by ET-1 was significantly blocked by PD-142893 and BQ-123 and attenuated by RES-701-1. Prior exposure of the preparation to indomethacin or meclofenamate failed to alter the attenuation of the evoked release of NPY-ir or the potentiation of the increase in perfusion pressure produced by ET-1 or ET-3. These results are consistent with the idea that sympathetic cotransmitters can be preferentially modulated by paracrine mediators at the vascular neuroeffector junction.