Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial.

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants. Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability. Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews. Results: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet's purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable. Conclusion: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.

Implementing evidence-based anticoagulant prescribing: User-centered design findings and recommendations.

Background: Direct oral anticoagulants (DOACs) are widely used medications with an unacceptably high rate of prescription errors and are a leading cause of adverse drug events. Clinical decision support, including medication alerts, can be an effective implementation strategy to reduce prescription errors, but quality is often inconsistent. User-centered design (UCD) approaches can improve the effectiveness of alerts. Objectives: To design effective DOAC prescription alerts through UCD and develop a set of generalizable design recommendations. Methods: This study used an iterative UCD process with practicing clinicians. In three rapid iterative design and assessment stages, prototype alert designs were created and refined using a test electronic health record (EHR) environment and simulated patients. We identified key emergent themes across all user observations and interviews. The themes and final designs were used to derive a set of design guidelines. Results: Our UCD sample comprised 13 prescribers, including advanced practice providers, physicians in training, primary care physicians, and cardiologists. The resulting alert designs embody our design recommendations, which include establishing intended indication, clarifying dosing by renal function, tailoring alert language in drug interactions, facilitating trust in alerts, and minimizing interaction overhead. Conclusions: Through a robust UCD process, we have identified key recommendations for implementing medication alerts aimed at improving evidence-based DOAC prescribing. These recommendations may be applicable to the implementation of DOAC alerts in any EHR systems.

Objective sleep duration and timing predicts completion of in vitro fertilization cycle.

PURPOSE: To examine associations between objectively measured sleep duration and sleep timing with odds of completion of an in vitro fertilization (IVF) cycle. METHODS: This prospective cohort study enrolled 48 women undergoing IVF at a large tertiary medical center between 2015 and 2017. Sleep was assessed by wrist-worn actigraphy, 1-2 weeks prior to initiation of the IVF cycle. Reproductive and IVF cycle data and demographic and health information were obtained from medical charts. Sleep duration, midpoint, and bedtime were examined in relation to IVF cycle completion using logistic regression models, adjusted for age and anti-Müllerian hormone levels. A sub-analysis excluded women who worked non-day shifts to control for circadian misalignment. RESULTS: The median age of all participants was 33 years, with 29% of women >35 years. Ten women had an IVF cycle cancelation prior to embryo transfer. These women had shorter sleep duration, more nocturnal awakenings, lower sleep efficiency, and later sleep timing relative to those who completed their cycle. Longer sleep duration was associated with lower odds of uncompleted IVF cycle (OR = 0.88; 95%CI 0.78, 1.00, per 20-min increment of increased sleep duration). Women with later sleep midpoint and later bedtime had higher odds of uncompleted cycle relative to those with earlier midpoint and earlier bedtime; OR = 1.24; 95%CI 1.09, 1.40 and OR = 1.33; 95%CI 1.17, 1.53 respectively, for 20-min increments. These results were independent of age, anti-Müllerian hormone levels, or sleep duration, and remained significant after exclusion of shift-working women. CONCLUSIONS: Shorter sleep duration and later sleep timing increase the odds of uncompleted cycles prior to embryo transfer.

Body mass index restrictions in fertility treatment: a national survey of OB/GYN subspecialists.

PURPOSE: To explore the attitudes of reproductive endocrinology and infertility (REI) and maternal-fetal medicine (MFM) subspecialists regarding the necessity and appropriateness of body mass index (BMI) cutoffs for women seeking fertility treatment. METHODS: Members of the Society for Reproductive Endocrinology and Infertility (SREI) and the Society for Maternal Fetal Medicine (SMFM) were invited to participate in a survey querying their knowledge of existing institutional or clinic BMI policies and personal opinions regarding upper and lower BMI cutoffs for a range of fertility treatments, including oral ovulation agents, gonadotropins, and in vitro fertilization. RESULTS: Respondents included 398 MFMs and 201 REIs. The majority of REI and MFM providers agreed with upper limit BMI cutoffs (72.5% vs 68.2%, p = 0.29), but REIs were twice as likely to support lower limit BMI restrictions compared to MFMs (56.2% vs 28.4%, p < 0.0001). Those who supported upper BMI restrictions were more likely to be female and report existing institutional BMI cutoffs. The majority of respondents (99.3%) believed that an official statement to guide clinicians should be issued by a national professional organization. CONCLUSIONS: Although practice patterns widely vary, the majority of REIs and MFMs believe that there should be a BMI cutoff above which women should not be offered immediate fertility treatment. Furthermore, there is a reported need for a written statement by a national professional organization to guide clinical practice and to ensure that OB/GYN subspecialists are providing consistent, fair, and safe recommendations to infertile women at the extremes of BMI.

Sleep in women undergoing in vitro fertilization: a pilot study.

OBJECTIVE: Sleep disturbances are thought to be frequent in women undergoing IVF despite minimal research of this hypothesis. Our goal was to longitudinally assess sleep duration and disturbances in women undergoing IVF and assess impact of habitual sleep duration on oocytes retrieved, an important outcome in IVF. METHODS: Actigraphy and questionnaire batteries containing sleep and psychometric instruments were performed prior to and throughout 24 IVF cycles. RESULTS: TST <7 h was present in 46%, 57%, 69%, and 42% of baseline, stimulation, post-oocyte retrieval, and post-embryo transfer recordings. ESS >10 was noted in 24%, 33%, and 36% of cycles during baseline, stimulation, and post-embryo transfer. PSQI >5 was noted in 57%, 43%, and 29% of cycles during baseline, stimulation, and post-embryo transfer. TST (F = 2.95, p = 0.04) and ESS (F = 4.36, p = 0.02) were the only sleep metrics in which a significant main effect of time was found by mixed models analysis. The final linear regression model chosen by stepwise selection to best explain the variability in oocytes retrieved included anti-mullerian hormone, day three follicle stimulating hormone, and baseline TST and explained 40% of the variance in oocytes retrieved (adjusted R2 = 0.40, p = 0.03). Although not statistically significant, a trend towards a linear association between baseline TST and oocytes retrieved was seen with an increase of oocytes retrieved by 1.5 for every hour increase in TST (p = 0.09). CONCLUSIONS: This is the first study to describe, with subjective and objective measures, sleep disturbances present throughout the IVF cycle. Importantly, a trend towards a linear relationship between TST and oocytes retrieved was found in this pilot study. Sleep may be a modifiable target to improve outcomes in women undergoing IVF and further investigations are needed.

Predicting postoperative day 1 hematocrit levels after uncomplicated hysterectomy.

OBJECTIVE: To develop a model for predicting postoperative hematocrit levels after uncomplicated hysterectomy. METHODS: In a retrospective study, data were analyzed from the Michigan Surgery Quality Collaborative for non-emergent hysterectomies performed for benign indications among women aged at least 18 years between January 1, 2012, and April 4, 2014. Linear mixed models were used for univariate and multivariate analyses. RESULTS: The model was developed with data from 4747 hysterectomies and validated on 1184 cases. In the mixed multivariate analysis, higher postoperative day 1 (POD1) hematocrit levels were associated with higher weight (B=0.03222, P<0.001), higher preoperative hematocrit (B=0.6587, P<0.001), and non-vaginal hysterectomy (B=0.2815, P=0.0055). Lower POD1 hematocrit was associated with higher preoperative platelet count (B=-0.00457, P<0.001), greater estimated blood loss (B=-0.00652, P<0.001), and larger intraoperative crystalloid volume (B=-0.3303, P<0.001). The final model predicted POD1 hematocrit within 4% points of the actual value for 91.7% of cases in the validation set. CONCLUSION: Use of the model after uncomplicated hysterectomy might help to support the practice of selectively conducting postoperative hematocrit tests after hysterectomy in a clinically thoughtful and cost-effective manner.