Baseline Observation Period Research Articles

P0952 Effect of a Care Pathway for Inflammatory Bowel Disease on Patient Outcomes and Healthcare Utilization: results of the IBD Value Study

Abstract Background Eight hospitals in the southwest of the Netherlands collaborate to improve care for patients with inflammatory bowel disease (IBD). This collaboration aims to deliver high quality and uniform care across the region. To achieve this, a care pathway (CP) was developed and implemented for the management of IBD with biologicals or small new molecules. The CP is a decision-support tool that provides guidelines for medication prescribing, procedures, treatment adjustments, and recommendations for follow-up. The aim of this study is to evaluate the effect of a CP on patient outcomes and healthcare utilization. Methods We designed a longitudinal multicentre non-randomised cohort study with a baseline observation period (December 2020 – December 2021) and a follow-up period (March 2022 – March 2023), in which adult patients with IBD treated with biologics or small new molecules were included (1). Outcomes were collected according to the International Consortium for Health Outcomes Measurement (ICHOM) standard set from electronic medical records or through validated questionnaires. Effect of the CP on these outcomes were analysed with case-mix adjusted (generalized) linear mixed models. Results A total of 1,173 patients participated in the study, with the majority being female (55%) and a median age of 45 years (IQR 33-58). Most patients had Crohn’s disease (64%). The CP was associated with a 14% increase in the probability of patient-reported disease control (p=0.54). Increases in probability were also observed for patient-reported (β=0.25, p=0.29) and biochemical remission (β=0.17, p=0.37), and the presence of active fistulas (β=0.28, p=0.44). Decreases in probability were found for biological (β=-0.04, p=0.84) and clinician-reported remission (β=-0.16, p=0.48). Emergency room visits (β=-0.32, p=0.18), hospital admissions (β=-0.28, p=0.28), and length of stay (β=-0.23, p=0.20) showed reduction, although these associations were also not significant. The CP had no effect on quality of life (β=0.01, p=0.35) or on anaemia probability (β=0.05, p=0.84). Conclusion A CP for the management of IBD with biologicals and small new molecule has clinically significant potential to reduce healthcare utilization, while improving patient-reported disease control, and biochemical remission. These results emphasize the potential of a CP to improve care for a complex disease as IBD. However, the adherence to the CP and whether these results lead to a reduction in healthcare costs, should be further investigated.

Napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura: a randomized controlled trial.

To observe the efficacy of napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura, and to compare its efficacy with simple napex acupoint thread-embedding and simple metoprolol tartrate tablet. A total of 105 patients with migraine without aura were randomized into a combination group (35 cases, 5 cases dropped out), a thread-embedding group (35 cases, 4 cases dropped out) and a western medication group (35 cases, 2 cases dropped out). In the thread-embedding group, napex acupoint thread-embedding was applied at bilateral Fengchi (GB 20) and points of 1.5 cun nearby to the lower edge of spinous process of cervical 2. In the western medication group, metoprolol tartrate tablet was given orally, 12.5 mg a time, twice a day. In the combination group, napex acupoint thread-embedding combined with oral metoprolol tartrate tablet was delivered. The treatment of 8 weeks was required in the 3 groups. The days of headache attacks, frequency of headache attacks, headache severity (visual analogue scale [VAS] score) and the migraine specific quality of life questionnaire version 2.1 (MSQ) score were observed during baseline period (4 weeks before treatment to before treatment), observation period (1-4 weeks and 5-8 weeks in treatment) and follow-up period (1-4 weeks after treatment completion) respectively, the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% were calculated, and the safety was evaluated in the 3 groups. During the observation period and the follow-up period, the days of headache attacks, frequency of headache attacks and headache VAS scores in the 3 groups were reduced compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the days of headache attacks and the frequency of headache attacks in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05); during the observation period (1-4 weeks in treatment), the headache VAS scores in the combination group and the thread-embedding group were lower than that in the western medication group (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the headache VAS scores in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were increased compared with those of the baseline period (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the role prevention scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05); during the follow-up period, the emotion function scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were higher than those in the thread-embedding group and the western medication group (P<0.05). There was no statistical difference in the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% among the 3 groups (P>0.05), and there were no serious adverse reactions in the 3 groups. Napex acupoint thread-embedding combined with metoprolol tartrate tablet, simple napex acupoint thread-embedding and simple metoprolol tartrate tablet all can reduce the days of headache attacks and the frequency of headache attacks, relieve headache severity and improve the quality of life in patients with migraine without aura. Napex acupoint thread-embedding combined with metoprolol tartrate tablet has a better effect.

Rate of motor progression in Parkinson's disease: a systematic review and meta-analysis.

The search for neuroprotective treatments for Parkinson's disease (PD) still relies largely on motor disability scales. A limitation of these tools is the strong influence of symptomatic dopaminergic treatment effects. Drawing on a wealth of published information, we conducted a systematic review and meta-analysis of motor progression in PD and its relationships with dopaminergic therapy. We searched Medline, Embase, and Central to identify 84 publications with adequate serial motor scores to calculate progression, expressed as an increase in the percentage of maximum disability. A random-effects model showed motor progression at 2.0% p.a. (95% CI 1.7-2.4%). There were no significant differences by baseline age, sample size, or observation period. However, untreated patients, in 8 publications, progressed at 4.5% p.a. compared to 1.6% p.a. in 76 studies containing individuals on dopaminergic drugs (p = 0.0004, q = 0.003). This was supported by research on phenoconversion in prodromal PD, where motor progression exceeded 5% p.a. in the 2 years before diagnosis. Starting levodopa improved pre-treatment disability by 40.3 ± 15.2%. Practically defined off state measurements increase faster than on scores by a modest degree (p = 0.05). This survey suggests that accurate long-term measurements of motor progression to assess disease-modifying therapies can be conducted despite the sequential commencement of dopaminergic drugs and sample attrition over time. While study designs involving prodromal or untreated PD avoid confounding effects of symptomatic treatment, different assumptions about motor progression may be needed. A defined off state with the levodopa test dose method maximizes information about the medication cycle once dopaminergic therapy has begun.

Vosoritide therapy in children with achondroplasia aged 3−59 months: a multinational, randomised, double-blind, placebo-controlled, phase 2 trial

Vosoritide is a recombinant C-type natriuretic peptide analogue that increases annualised growth velocity in children with achondroplasia aged 5-18 years. We aimed to assess the safety and efficacy of vosoritide in infants and children younger than 5 years. This double-blind, randomised, placebo-controlled, phase 2 trial was done in 16 hospitals across Australia, Japan, the UK, and the USA. Children younger than 60 months with a clinical diagnosis of achondroplasia confirmed by genetic testing and who had completed a baseline growth study or observation period were enrolled into one of three sequential cohorts based on age at screening: 24-59 months (cohort 1); 6-23 months (cohort 2); and 0-5 months (cohort 3). Each cohort included sentinels who received vosoritide to determine appropriate daily drug dose, with the remainder randomly assigned (1:1) within each age stratum (except in Japan, where participants were randomly assigned within each cohort) to receive daily subcutaneous injections of vosoritide (30·0 μg/kg for infants aged 0-23 months; 15·0 μg/kg for children aged 24-59 months) or placebo for 52 weeks. Participants, caregivers, investigators, and the sponsor were masked to treatment assignment. The first primary outcome was safety and tolerability, assessed in all participants who received at least one study dose. The second primary outcome was change in height Z score at 52 weeks from baseline, analysed in all randomly assigned participants. This trial is registered with EudraCT, 2016-003826-18, and ClinicalTrials.gov, NCT03583697. Between May 13, 2018, and March 1, 2021, 75 participants were recruited (37 [49%] females). 11 were assigned as sentinels, whereas 32 were randomly assigned to receive vosoritide and 32 placebo. Two participants discontinued treatment and the study: one in the vosoritide group (death) and one in the placebo group (withdrawal). Adverse events occurred in all 75 (100%) participants (annual rate 204·5 adverse events per patient in the vosoritide group and 73·6 per patient in the placebo group), most of which were transient injection-site reactions and injection-site erythema. Serious adverse events occurred in three (7%) participants in the vosoritide group (decreased oxygen saturation, respiratory syncytial virus bronchiolitis and sudden infant death syndrome, and pneumonia) and six (19%) participants in the placebo group (petit mal epilepsy, autism, gastroenteritis, vomiting and parainfluenza virus infection, respiratory distress, and skull fracture and otitis media). The least-squares mean difference for change from baseline in height Z score between the vosoritide and placebo groups was 0·25 (95% CI -0·02 to 0·53). Children with achondroplasia aged 3-59 months receiving vosoritide for 52 weeks had a mild adverse event profile and gain in the change in height Z score from baseline. BioMarin Pharmaceutical.

Identifying Measures of Suboptimal Healthcare Interaction (SOHI) to Develop a Claims-Based Model for Predicting Patients with Inflammatory Bowel Disease at Risk for SOHI.

Understanding the demographic and clinical characteristics of patients with Inflammatory Bowel Disease (IBD) who are likely to experience poor disease outcomes may allow early interventions that can improve health outcomes. To describe demographic and clinical characteristics of patients with ulcerative colitis (UC) and Crohn's disease (CD) with the presence of at least one Suboptimal Healthcare Interaction (SOHI) event, which can inform the development of a model to predict SOHI in members with IBD based on insurance claims, with the goal of offering these patients some additional intervention. We identified commercially insured individuals with IBD between 01 January 2019 and 31 December 2019 using Optum Labs' administrative claims database. The primary cohort was stratified on the presence or absence of ≥1 SOHI event (a SOHI-defining data point or characteristic at a specific time point) during the baseline observation period. SOHI was deployed as the basis for the development of a model to predict which individuals with IBD were most likely to continue to have SOHI within a 1-year timeframe (follow-up SOHI) using insurance claims data. All baseline characteristics were analyzed descriptively. Multivariable logistic regression was used to examine the association of follow-up SOHI with baseline characteristics. Of 19,824 individuals, 6872 (34.7%) were found to have follow-up SOHI. Individuals with follow-up SOHI were more likely to have had similar SOHI events in the baseline period than those with non-SOHI. A significantly greater proportion of individuals with SOHI had ≥1 claims-based C-reactive protein (CRP) test order and ≥1 CRP lab results compared with non-SOHI. Individuals with follow-up SOHI were more likely to incur higher healthcare expenditures and resource utilization as compared with non-SOHI individuals. A few of the most important variables used to predict follow-up SOHI included baseline mesalamine use, count of baseline opioid fills, count of baseline oral corticosteroid fills, baseline extraintestinal manifestations of disease, proxy for baseline SOHI, and index IBD provider specialty. Individuals with SOHI are likely to have higher expenditures, higher healthcare resource utilization, uncontrolled disease, and higher CRP lab results as compared with non-SOHI members. Distinguishing SOHI and non-SOHI patients in a dataset could efficiently identify potential cases of poor future IBD outcomes.

An evening light intervention reduces fatigue and errors during night shifts: A randomized controlled trial

ObjectiveShift work causes circadian rhythms to misalign with the demands of the environment, which has been associated with sleep difficulties and cognitive impairments. Although bright light exposure during night shifts can improve circadian alignment, its implementation is often infeasible. Here, we tested whether light exposure in the evening, before the night shift, could improve fatigue, work performance, mood, and sleep. MethodsFifty-seven healthy nurses who worked full-time rapidly rotating shift schedules completed the study. In a mixed-design randomized controlled trial, participants completed a baseline observation period before following 1 of 2 interventions. The experimental intervention aimed to improve circadian alignment using evening light exposure and morning light avoidance; the control intervention aimed to improve alertness and reduce sleep disturbances by modifying diet. Every morning and evening for 30 days, participants completed measures of fatigue, work-related errors, sleepiness, mood, sleep duration, and sleep quality. ResultsCompared to the baseline observation period, the experimental intervention reduced errors by 67%, while the control intervention reduced them by only 5%. This reduction was partially mediated by fatigue; experimental participants reported less fatigue on work days than control participants (d = 0.25 [0.10, 0.38]). The experimental group also showed a small improvement in mood. Both groups showed reductions in fatigue (d = 0.29 [0.20, 0.36]) and sleepiness (d = 0.21 [0.12, 0.28]) as well as a small increase in sleep duration. ConclusionsInterventions based on evening light may be a feasible and effective strategy to reduce fatigue and errors in night-shift workers.

Compensatory effects of different exercise durations on non-exercise physical activity, appetite, and energy intake in normal weight and overweight adults.

Objectives: To examine compensatory changes of different exercise durations on non-exercise physical activity (NEPA), appetite, and energy intake (EI) in normal and overweight adults, and to determine if different body mass index of individuals interact with these compensatory effects. Methods: Ten normal weight adults (nine females and one male; age: 24.0 ± 0.4 years; BMI: 20.7 ± 0.5 kg/m2) and ten overweight adults (six females and four males; age: 24.5 ± 0.9 years; BMI: 25.9 ± 0.4 kg/m2) participated in this study. The participants completed two exercise trials: short-duration continuous training (SDCT) and long-duration continuous training (LDCT), i.e., a 40 min short-duration and an 80 min long-duration continuous training in a randomized order. Total physical activity and NEPA were monitored using an accelerometer for seven consecutive days, which involved a two-day baseline observation period (C-pre-Ex), three-day exercise intervention period (Ex), and two-day follow-up period (C-post-Ex). Blood samples were collected for appetite-related hormone analysis. Appetite score was assessed using the visual analogue scale. Energy intake was evaluated by weighing the food and recording diaries. Results: The NEPA evaluation showed that it was higher for SDCT than for LDCT in the C-post-Ex period (F (1, 19) = 8.508, p = 0.009) in the total sample. Moreover, results also indicated that NEPA was lower for LDCT (F (2, 18) = 6.316, p = 0.020) and higher for SDCT (F (2, 18) = 3.889, p = 0.026) in the C-post-Ex period than in the C-pre-Ex and Ex periods in overweight group. Acyl-ghrelin revealed a main effect of time in the total sample and in normal weight and overweight groups; it was lower in the C-post-Ex period than in the C-pre-Ex and Ex periods (all p < 0.05). Total EI analysis revealed no significant changes in either the total sample or in the normal weight and overweight groups. Conclusion: These findings demonstrate that short duration exercise led to a compensatory increment in NEPA, whereas long duration exercise induced a compensatory decrease in NEPA. Moreover, there was a higher and delayed compensatory response in overweight adults than in normal weight adults. Nevertheless, energy intake was not changed across time, regardless of exercise duration.

Risk Factors Associated with Healthcare Utilization for Spine Pain.

This study examined potential risk factors associated with healthcare utilization among patients with spine (i.e., neck and back) pain. A two-stage sampling approach examined spine pain episodes of care among veterans with a yearly outpatient visit for six consecutive years. Descriptive and bivariate statistics, followed by logistic regression analyses, examined baseline characteristics of veterans with new episodes of care who either continued or discontinued spine pain care. A multivariable logistic regression model examined correlates associated with seeking continued spine pain care. Among 331,908 veterans without spine pain episodes of care during the 2-year baseline observation period, 16.5% (n = 54,852) had a new episode of care during the following 2-year observation period. Of those 54,852 veterans, 37,025 had an outpatient visit data during the final 2-year follow-up period, with 53.7% (n = 19,865) evidencing continued spine pain care. Those with continued care were more likely to be overweight or obese, non-smokers, Army veterans, have higher education, and had higher rates of diagnoses of all medical and mental health conditions examined at baseline. Among several important findings, women had 13% lower odds of continued care during the final 2-year observation period, OR 0.87 (0.81, 0.95). A number of important demographics and clinical correlates were associated with increased likelihood of seeking new and continued episodes of care for spine pain; however, further examination of risk factors associated with healthcare utilization for spine pain is indicated.

93. Early Recognition and Response to Increases in Surgical Site Infections (SSI) using Optimized Statistical Process Control (SPC) Charts – the Early 2RIS Trial: A Multicenter Stepped Wedge Cluster Randomized Controlled Trial (RCT)

BackgroundTraditional approaches for SSI surveillance have deficiencies that can delay detection of SSI outbreaks and other clinically important increases in SSI rates. Optimized SPC methods for SSI surveillance have not been prospectively evaluated.MethodsWe conducted a prospective multicenter stepped wedge cluster RCT to evaluate the performance of SSI surveillance and feedback performed with optimized SPC plus traditional surveillance methods compared to traditional surveillance alone. We divided 13 common surgical procedures into 6 clusters (Table 1). A cluster of procedures at a single hospital was the unit of randomization and analysis, and 105 total clusters across 29 community hospitals were randomized to 12 groups of 8-10 clusters (Figure 1). After a 12-month baseline observation period (3/2016-2/2017), the SPC surveillance intervention was serially implemented according to stepped wedge assignment over a 36-month intervention period (3/2017-2/2020) until all 12 groups of clusters had received the intervention. The primary outcome was the overall SSI prevalence rate (PR=SSIs/100 procedures), evaluated with a GEE model with Poisson distribution.Table 1 Figure 1 Schematic for stepped wedge design. The 12-month baseline observation period was followed by the 36-month intervention period, comprised of 12 3-month steps.ResultsOur trial involved prospective surveillance of 237,704 procedures that resulted in 1,952 SSIs (PR=0.82). The overall SSI PR did not differ significantly between clusters of procedures assigned to SPC surveillance (781 SSIs/89,339 procedures; PR=0.87) and those assigned to traditional surveillance (1,171 SSIs/148,365 procedures; PR=0.79; PR ratio=1.10 [95% CI, 0.94–1.30]; P=.25) (Table 2). SPC surveillance identified 104 SSI rate increases that required formal investigations, compared to only 25 investigations generated by traditional surveillance. Among 10 best practices for SSI prevention, 453 of 502 (90%) SSIs analyzed due to SPC detection of SSI rate increases had at least 2 deficiencies (Table 3).Table 2 Poisson regression models comparing surgical site infection (SSI) prevalence rates for procedure clusters receiving statistical process control surveillance to SSI rates for clusters receiving traditional control surveillance.Table 3 Compliance with 10 best practices for surgical site infection (SSI) prevention among 502 SSIs analyzed during SSI investigations generated by statistical process control surveillance.ConclusionSPC methods more frequently detected important SSI rate increases associated with deficiencies in SSI prevention best practices than traditional surveillance; however, feedback of this information did not lead to SSI rate reductions. Further study is indicated to determine the best application of SPC methods to improve adherence to SSI quality measures and prevent SSIs.Disclosures Arthur W. Baker, MD, MPH, Medincell (Advisor or Review Panel member) Susan S. Huang, MD, MPH, Medline (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Molnlycke (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Stryker (Sage) (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)Xttrium (Other Financial or Material Support, Conducted studies in which participating hospitals and nursing homes received contributed antiseptic and cleaning products)

Across-subjects multiple baseline trial of exposure-based cognitive-behavioral therapy for severe irritability: a study protocol

IntroductionIrritability is defined as a tendency towards anger in response to frustration. Clinically, impairing irritability is a significant public health problem. There is a need for mechanism-based psychotherapies targeting severe...

593 Ambient Room Temperature in a Burn Intensive Care Unit - A Quality Improvement Project

Abstract Introduction In patients with burns &amp;gt; 20% TBSA, hypermetabolism, evaporative water loss, infection risk and discomfort are all amplified by exposure to cold ambient temperatures. Post-operative patient hypothermia is also detrimental. It is essential to not only maintain a warm patient room temperature, but also to be able to rapidly increase room temperature in the burn ICU. The purpose of this study was to measure typical patient room temperatures in a burn ICU at an adult regional ABA-verified burn center, and to evaluate our ability to intervene and raise room temperature. Methods The ambient temperatures of nine patient rooms were recorded from 14 June to 14 August, 2019. Temperature was measured every minute by a wall-mounted smart sensor placed at standardized positions away from windows or electronic equipment. All devices were tested prior to use, with temperature and humidity accurate and standardized to &amp;lt; 0.2oC and 2% respectively at 18-25oC. Data was transmitted to a mobile smartphone. On 15 August 2019 all room temperatures were manually adjusted to ‘maximum’. This was identified as a sound change initiative, and replicated a potential medical order to increase the ambient temperature should a hypothermic patient be imminently returning from the operating room or resuscitation area after admission. Results Over the baseline observation period (Figure 1) the mean ± SD room temperature was 23.3 ± 1oC. Temperatures deviated below a mean of 22oC during 166 hours per room (11.5%, range 3–362). Following the intervention on 15 August (Figure 2), ambient temperature increased minimally in 6/9 rooms and only by 2–3°C in two rooms (mean rise of 1.03oC; range -0.88oC to 3.26oC). Conclusions The burn ICU rooms are relatively cold and our ability to raise ambient temperature quickly is limited. Further QI change ideas include: 1) a facility engineering assessment 2) set alarms on the smart sensors to alert staff when room temperature falls below a designated threshold. Applicability of Research to Practice This project has identified an important future QI initiative to maintain warm ambient patient room temperatures in the burn ICU.

Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial.

To assess the feasibility and efficacy of implementing "Family Care Rituals" as a means of engaging family members in the care of patients admitted to the ICU with a high risk of ICU mortality on outcomes including stress-related symptoms in family members. Prospective, before-and-after intervention evaluation. Two U.S. academic medical ICU's, and one Italian academic medical/surgical ICU. Family members of patients who had an attending predicted ICU mortality of greater than 30% within the first 24 hours of admission. A novel intervention titled "Family Care Rituals" during which, following a baseline observation period, family members enrolled in the intervention phase were given an informational booklet outlining opportunities for engagement in care of the patient during their ICU stay. Primary outcome was symptoms of post-traumatic stress disorder in family members 90 days after patient death or ICU discharge. Secondary outcomes included symptoms of depression, anxiety, and family satisfaction. At 90-day follow-up, 131 of 226 family members (58.0%) responded preintervention and 129 of 226 family members (57.1%) responded postintervention. Symptoms of post-traumatic stress disorder were significantly higher preintervention than postintervention (39.2% vs 27.1%; unadjusted odds ratio, 0.58; p = 0.046). There was no significant difference in symptoms of depression (26.5% vs 25.2%; unadjusted odds ratio, 0.93; p = 0.818), anxiety (41.0% vs 45.5%; unadjusted odds ratio, 1.20; p = 0.234), or mean satisfaction scores (85.1 vs 89.0; unadjusted odds ratio, 3.85; p = 0.052) preintervention versus postintervention 90 days after patient death or ICU discharge. Offering opportunities such as family care rituals for family members to be involved with providing care for family members in the ICU was associated with reduced symptoms of post-traumatic stress disorder. This intervention may lessen the burden of stress-related symptoms in family members of ICU patients.

Mindfulness-based skills training group for parents of obsessive-compulsive disorder-affected children: A caregiver-focused intervention

Background and purposeParents of children with obsessive-compulsive disorder (OCD) report significant emotional and socio-occupational impacts. There is, however, currently insufficient support for these parents. This study examined a mindfulness-based intervention for parents of OCD-affected children, investigating its feasibility and impact on parental ability to tolerate their child's OCD-related distress, in addition to exploring potential indirect effects. Materials and methodsParents of OCD-affected children (n = 39) completed an eight-week baseline observation period followed by eight, weekly manualized mindfulness-based intervention group sessions. Measures of parental tolerance of child distress, dispositional mindfulness, family accommodation, family functioning, and OCD symptom severity were collected. ResultsIn comparison to the baseline observation period, parental tolerance of child distress and dispositional mindfulness significantly improved following mindfulness training. No other temporal differences were observed. Parents reported high satisfaction. ConclusionMindfulness-based skills training for parents of OCD-affected youth appears to be feasible and to significantly increase tolerance related to the child's distress. Clinical trial registration numberNCT03212703.

Reducing Repetitive and Reflexive Diagnostic Phlebotomy in an Intensive Care Unit: A Quality Improvement Project

Background Laboratory testing is a core component of contemporary medical care. However, repetitive diagnostic phlebotomy has been associated with anemia and higher transfusion burden, both of which are associated with increased mortality. The potential harm of repetitive blood testing is particularly pronounced in the intensive care unit (ICU). Critically ill patients receive a high volume of blood tests due to their need for intensive intervention and monitoring. In addition, ICU patients often suffer from anemia of inflammation which impairs effective erythropoiesis and may exacerbate net red cell loss resulting from repetitive blood testing. Aim Modeling data suggests that a 15% decrease in the amount of blood drawn may result in clinically meaningful decrease in ICU anemia.We aimed to reduce the average volume of blood collected per patient-day by 15% by June 30, 2019 by developing and implementing a patient-centered, diagnostic phlebotomy strategy in the Medical-Surgical Intensive Care Unit (MSICU) at an academic tertiary care center in Toronto, Canada. Methods A series of change strategies were implemented in a single-site, 25-bed MSICU between February and July 2019. The strategy included: stake-holder engagement, education sessions, process changes to encourage patient-centered lab ordering, electronic order set modifications to deter open-ended and unnecessary lab ordering, order changes to facilitate add-on testing, and audit and feedback regarding the average volume of blood collected per patient-day in the MSICU. Baseline data from July 2018 to January 2019 was collected retrospectively using administrative data. The main outcome measure was average volume of blood collected per patient-day in the MSICU. Balance measures included average discrete blood draws, ICU length of stay and mortality. The statistical stability of the main outcome measure over time was explored with Shewhart chart (I-chart) analysis. The student's T-Test was also used to compare the mean blood collected per patient-day in the ICU at baseline versus post-intervention. Results Baseline data from July 2018 to January 2019 revealed a mean of 46.8 mL of blood was collected per patient-day (including wastage). The volume of blood collected per patient-day was stable during the baseline observation period. Direct observations and process mapping of the blood ordering processes suggested that repetitive and reflexive blood testing was common in the MSICU. Change strategies were successively introduced between February and June 2019. During the study period average blood volume collected decreased from 46.8ml per patient-day to 36.0 mL per patient day. Special cause variation was observed 6 weeks into the intervention (p &amp;lt; 0.001). The average number of discrete blood draws also decreased from 4.1 to 3.7 per patient day. Conclusion Sequential, patient-centered interventions discouraging reflexive and unnecessarily repetitive blood testing in an ICU were associated with a significant decrease in average blood volumes collected per patient-day. Future analyses will explore whether the observed decrease in daily phlebotomy volumes was associated with any changes in patient outcomes such as transfusion burden, ICU length of stay and mortality. Disclosures Sholzberg: Novartis: Honoraria; Amgen: Honoraria, Research Funding.

Adblock Usage in Web Advertisement

Web users are increasingly turning to ad blockers to avoid ads, which are often perceived as annoying or an invasion of privacy. While there has been significant research into the factors driving ad blocker adoption and the detrimental effect to ad publishers on the Web, the resulting effects of ad blocker usage on Web users’ browsing experience is not well understood. To approach this problem, we conduct a retrospective natural field experiment using Firefox browser usage data, with the goal of estimating the effect of ad blocking on user engagement with the Web. We focus on new users who installed an ad blocker after a baseline observation period, to avoid comparing different populations. Their subsequent browser activity is compared against that of a control group, whose members do not use ad blockers, over a corresponding observation period, controlling for prior baseline usage. In order to estimate causal effects, we employ propensity score matching on a number of other features recorded during the baseline period. In the group that installed an ad blocker, we find significant increases in both active time spent in the browser (+28% over control) and the number of pages viewed (+15% over control), while seeing no change in the number of searches. Additionally, by reapplying the same methodology to other popular Firefox browser extensions, we show that these effects are specific to ad blockers. We conclude that ad blocking has a positive impact on user engagement with the Web, suggesting that any costs of using ad blockers to users’ browsing experience are largely drowned out by the utility that they offer.

The CVC and CRBSI: don’t use it and lose it!

In a recent article in Intensive Care Medicine, van der Kooi and colleagues report on the PROHIBIT trial aimed at preventing catheter-related bloodstream infections (CRBSI) in intensive care units (ICU) [1]. Following a baseline observation period, the investigators randomly allocated 14 ICUs to interventions that included a catheter insertion and care and hand hygiene improvement strategies. Participating ICUs were geographically distributed in Europe among 11 culturally diverse countries and were university-affiliated in one half of cases. Catheter insertion practices and hand hygiene adherence improved with the assigned interventions and these had significant reduction in the primary outcome of incidence density of CRBSI...

Preventing Hereditary Angioedema Attacks in Children Using Cinryze®: Interim Efficacy and Safety Phase 3 Findings

Background: Hereditary angioedema (HAE) is a rare genetic disease causing unpredictable and potentially life-threatening subcutaneous and submucosal edematous attacks. Cinryze® (Shire ViroPharma Inc., Lexington, MA, USA), a nanofiltered C1 inhibitor (C1-INH), is approved in Europe for the treatment, preprocedure prevention, and routine prophylaxis of HAE attacks, and for the routine prophylaxis of attacks in the USA. This phase 3 study assessed the safety and efficacy of 2 C1-INH doses in preventing attacks in children aged 6-11 years. Methods: A randomized single-blind crossover study was initiated in March 2014. Results for the first 6 patients completing the study are reported here. After a 12-week qualifying observation period, patients were randomly assigned to 1 of 2 C1-INH doses, 500 or 1,000 U, every 3-4 days for 12 weeks and crossed over to the alternative dose for a second 12-week period. The primary efficacy endpoint was the number of angioedema attacks per month. Results: Six females with HAE type I and a median age of 10.5 years received 2 doses of C1-INH (500 and 1,000 U). The mean (SD) difference in the number of monthly angioedema attacks between the baseline observation period and the treatment period was -1.89 (1.31) with 500 U and -1.89 (1.11) with 1,000 U. During the treatment periods, cumulative attack severity, cumulative daily severity, and the number of attacks needing acute treatment were lower. No serious adverse events or study drug discontinuations occurred. Conclusions: Interim findings from this study indicate that routine prevention with intravenous administration of C1-INH is efficacious, safe, and well tolerated in children ≥6 years of age.

Buying health: assessing the impact of a consumer-side vegetable subsidy on purchasing, consumption and waste.

To measure the impact of a reimbursement-based consumer subsidy on vegetable expenditures, consumption and waste. Two-arm randomized controlled trial; two-week baseline observation period, three-week intervention period. Participants' vegetable expenditures, consumption and waste were monitored using receipts collection and through an FFQ. During the intervention period, the treatment group received reimbursement of up to 50 US dollars ($) for purchased vegetables. Participants were solicited from Palo Alto, CA, USA using materials advertising a 'consumer behavior study' and a small participation incentive. To prevent selection bias, solicitation materials did not describe the specific behaviour being evaluated. One hundred and fifty potential participants responded to the solicitations and 144 participants enrolled in the study; 138 participants completed all five weekly surveys. Accounting for the control group (n 69) and the two-week baseline period, the intervention significantly impacted the treatment group's (n 69) vegetable expenditures (+$8.16 (sd 2.67)/week, P<0.01), but not vegetable consumption (+1.3 (sd 1.2) servings/week, P=0.28) or waste (-0.23 (sd 1.2) servings/week, P=0.60). The consumer subsidy significantly increased participants' vegetable expenditures, but not consumption or waste, suggesting that this type of subsidy might not have the effects anticipated. Reimbursement-based consumer subsidies may therefore not be as useful a policy tool for impacting vegetable consumption as earlier studies have suggested. Moreover, moderation analysis revealed that the subsidy's effect on participants' vegetable expenditures was significant only in men. Additional research should seek to determine how far reaching gender-specific effects are in this context. Further research should also examine the effect of a similar consumer subsidy on high-risk populations and explore to what extent increases in participants' expenditures are due to the purchase of more expensive vegetables, purchasing of vegetables during the study period that were consumed outside the study period, or a shift from restaurant vegetable consumption to grocery vegetable consumption.

Use of provider-level dashboards and pay-for-performance in venous thromboembolism prophylaxis.

Despite safe and cost-effective venous thromboembolism (VTE) prevention measures, VTE prophylaxis rates are often suboptimal. Healthcare reform efforts emphasize transparency through programs to report performance and payment incentives through pay-for-performance programs. To sequentially examine an individualized physician dashboard and pay-for-performance program to improve VTE prophylaxis rates among hospitalists. Retrospective analysis of 3144 inpatient admissions. After a baseline observation period, VTE prophylaxis compliance was compared during both interventions. A 1060-bed tertiary care medical center. Thirty-eight part-time and full-time academic hospitalists. A Web-based hospitalist dashboard provided VTE prophylaxis feedback. After 6 months of feedback only, a pay-for-performance program was incorporated, with graduated payouts for compliance rates of 80% to 100%. Prescription of American College of Chest Physicians' guideline-compliant VTE prophylaxis and subsequent pay-for-performance payments. Monthly VTE prophylaxis compliance rates were 86% (95% confidence interval [CI]: 85-88), 90% (95% CI: 88-93), and 94% (95% CI: 93-96) during the baseline, dashboard, and combined dashboard/pay-for-performance periods, respectively. Compliance significantly improved with the use of the dashboard (P = 0.01) and addition of the pay-for-performance program (P = 0.01). The highest rate of improvement occurred with the dashboard (1.58%/month; P = 0.01). Annual individual physician performance payments ranged from $53 to $1244 (mean $633; standard deviation ±$350). Direct feedback using dashboards was associated with significantly improved compliance, with further improvement after incorporating an individual physician pay-for-performance program. Real-time dashboards and physician-level incentives may assist hospitals in achieving higher safety and quality benchmarks.

Impact of clinical decision support on head computed tomography use in patients with mild traumatic brain injury in the ED

BackgroundReduction of unnecessary head computed tomographies (CTs) in patients with mild traumatic brain injury (MTBI) was recently endorsed by American College of Emergency Physicians (ACEP) in the “Choosing Wisely” campaign. We examined the impact of computerized clinical decision support (CDS) on head CT utilization in MTBI emergency department (ED) visits. MethodsWe conducted a 2-year cohort study at a level 1 trauma center and compared our results with the National Hospital Ambulatory Medical Care Survey from 2009 to 2010. All adult patients discharged from the ED with MTBI-associated diagnoses were included. After a baseline observation period at our institution, real-time CDS was implemented. Based upon the clinical history entered, low utility orders triggered an alert to clinicians, suggesting imaging studies might not adhere to evidence-based guidelines. Clinicians could cancel the order or ignore the alert. Primary outcome was intensity of head CT use in MTBI ED visits. Secondary outcomes included rates of delayed imaging and delays in diagnosing radiologically significant findings. χ2, logistic regression, and process control chart assessed preintervention and postintervention differences. ResultsIn study patients, 58.1% of MTBI-related visits resulted in head CT preintervention vs 50.3% postintervention (13.4% relative decrease, P = .005), a change not detected in controls (73.3% vs 76.9%, P = .272). Study cohort patients not receiving a head CT during their index visit were neither more nor less likely to receive one in the subsequent 7 days (6.7% preintervention vs 9.4% postintervention, P = .231). Rates of delayed diagnosis of radiologically significant findings were unchanged (0% vs 0%). ConclusionsEvidence-based CDS can reduce low utility imaging for MTBI.