Concurrent Control Group Research Articles

Evaluation of an mHealth tool to improve nutritional assessment among infants under 6 months in paediatric development clinics in rural Rwanda: Quasi-experimental study.

Infants born preterm, low birthweight or with other perinatal complications require frequent and accurate growth monitoring for optimal nutrition and growth. We implemented an mHealth tool to improve growth monitoring and nutritional status assessment of high risk infants. We conducted a pre–post quasi‐experimental study with a concurrent control group among infants enrolled in paediatric development clinics in two rural Rwandan districts. During the pre‐intervention period (August 2017–January 2018), all clinics used standard paper‐based World Health Organization (WHO) growth charts. During the intervention period (August 2018–January 2019), Kirehe district adopted an mHealth tool for child growth monitoring and nutritional status assessment. Data on length/height; weight; length/height‐for‐age (L/HFA), weight‐for‐length/height (WFL/H) and weight‐for‐age (WFA) z‐scores; and interval growth were tracked at each visit. We conducted a ‘difference‐in‐difference’ analysis to assess whether the mHealth tool was associated with greater improvements in completion and accuracy of nutritional assessments and nutritional status at 2 and 6 months of age. We observed 3529 visits. mHealth intervention clinics showed significantly greater improvements on completeness for corrected age (endline: 65% vs. 55%; p = 0.036), L/HFA (endline: 82% vs. 57%; p ≤ 0.001), WFA (endline: 93% vs. 67%; p ≤ 0.001) and WFL/H (endline: 90% vs. 59%; p ≤ 0.001) z‐scores compared with control sites. Accuracy of growth monitoring did not improve. Prevalence of stunting, underweight and inadequate interval growth at 6‐months corrected age decreased significantly more in the intervention clinics than in control clinics. Results suggest that integrating mHealth nutrition interventions is feasible and can improve child nutrition outcomes. Improved tool design may better promote accuracy.

L-citrulline: A preclinical safety biomarker for the small intestine in rats and dogs in repeat dose toxicity studies

IntroductionGastrointestinal (GI) toxicity is still an issue within drug development, especially for novel oncology drugs. The identification of GI mucosal damage at an early stage with high sensitivity and specificity across preclinical species and humans remains difficult. To date, in preclinical studies, no qualified mechanistic, diagnostic or prognostic biomarkers exist for GI mucosal toxicity. l-citrulline is one of the most promising biomarker candidates used in clinical settings to quantify enterocyte integrity in various small intestinal diseases. l-citrulline is an intermediate metabolic amino acid produced mainly by functional enterocytes of the small intestine, whereby enterocyte loss will cause a drop in circulating l-citrulline. MethodsIn several repeat-dose toxicity studies, plasma l-citrulline has been evaluated as a potential safety biomarker for intestinal toxicity in beagle dogs and Wistar (Han) rats treated with different oncological drug candidates in drug development. Clinical observations and body weight determinations were performed during the pretreatment, treatment and treatment-free recovery period as well as toxicokinetic, gross and histopathology examinations. The quantitative determination of plasma l-citrulline levels during the pretreatment (only dogs), treatment and treatment-free recovery period were performed using an HPLC MS/MS assay. In cynomolgus monkeys, the first investigations on baseline l-citrulline levels were performed. ResultsIn dogs, a dose- and exposure-dependent decrease of up to 50% in plasma l-citrulline was seen without histopathological alterations. However, a decrease of more than 50% in comparison to the individual animal pretreatment value of l-citrulline correlated very well with histopathological findings (intestinal crypt necrosis, villus atrophy, enterocyte loss) and clinical signs (bloody faeces and diarrhoea). During a treatment-free recovery period, a trend of increasing levels was observed in dogs. In rats, absolute l-citrulline plasma levels of treated animals decreased compared to the values of the concurrent control group. This decrease also correlated with the histopathological findings in the small intestine (single cell necrosis and mucosa atrophy). Because of a large physiological variation in l-citrulline plasma levels in dogs and rats, a clear cut-off value for absolute l-citrulline levels predictive of intestinal mucosal toxicity was difficult to establish. However, a > 50% decrease in l-citrulline plasma levels during the treatment period strongly correlated with histopathological findings. DiscussionBased on the performed analysis, a longitudinal investigation of l-citrulline plasma levels for individual animals in the control and treatment groups is essential and pretreatment values of l-citrulline levels in rodents would be highly informative. Overall, further cross-species comparison (Cynomolgus monkey, mouse) and implementation in clinical trials as exploratory biomarker is essential to foster the hypothesis and to understand completely the clinical relevance of l-citrulline as a small intestine biomarker.

The potential developmental neurotoxicity of calcium cyclamate in CD rats

The developmental neurotoxicity of calcium cyclamate was evaluated in Sprague Dawley [Crl:CD(SD)] rats, administered in drinking water, in comparison to a concurrent control group (water) and a positive control group given propylthiouracil (PTU). Calcium cyclamate was administered to F0 females for 4 weeks prior to pairing, throughout mating, gestation and lactation and to F1 offspring from weaning to 12 weeks of age, PTU was administered by gavage to F0 females from Day 6 of gestation up to Day 20 of lactation. Target calcium cyclamate doses were 0, 250, 500 and 1,000 mg/kg bw/day, while the PTU dose was 0.5 mg/kg bw/day. No treatment-related effects of cyclamate were observed in either the F0 or F1 generations on reproductive performance or neurobehavioral development. In comparison, PTU exposure resulted in developmental delays, memory impairment and a number of neuropathological and morphometric outcomes. The results from the unique developmental neurotoxicity study design, corroborate the absence of hyperactivity and any other neurotoxic effects following cyclamate administration at levels up to 878 mg/kg bw/day in F0 females and 784 mg/kg bw/day in F1 animals. This demonstrates the suitability of PTU as a positive control and confirms the safe use of cyclamate as a no-calorie sweetener.

STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients

BackgroundSafe introduction of novel mechanical circulatory support (MCS) devices into clinical practice is a challenging process. Single-arm trials using a control arm from existing database is an effective alternative that could be applied for regulatory approval. This study analyzes the capability of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database to establish objective performance criteria and select patient population that could be used for future single-arm MCS trials. MethodsPatients with INTERMACS profiles IM1-2 and IM3-5, who underwent implantation of isolated left ventricular assist devices between 2014 and 2017, were included. Both cohorts were further stratified into shock and nonshock groups using surrogate markers of shock (extracorporeal membrane oxygenation, temporary ventricular assist device, vasopressor infusions). Survival, transplantation rates, adverse events, 6-minute walk test, and quality-of-life measures were obtained for all 4 groups at 6 and 12 months. ResultsTotal of 7907 patients were divided into IM1-2 (n = 3909), IM3-5 (n = 3998), shock (n = 3469), and nonshock (n = 3040) groups. Recategorization occurred in 11% of patients from the IM3-5 group into the shock group. Overall, patients in the shock group had similar outcomes to the IM1-2 group (1-year survival: 86% vs 85%; P = .74). Patients in the nonshock group also had similar outcomes to the IM3-5 (1-year survival: 90% vs 90%; P = .43). ConclusionsThe INTERMACS database can successfully establish objective performance criteria and concurrent control group for single-arm trials that could be used to support regulatory approval of new, less invasive MCS. INTERMACS data allow reliable comparisons of outcomes and adverse events.

Comparative Effectiveness of a Complex Care Program for High-Cost/High-Need Patients: a Retrospective Cohort Study.

High-cost/high-need (HCHN) adults and the healthcare systems that provide their care may benefit from a new patient-centered model of care involving a dedicated physician and nurse team who coordinate both clinical and social services for a small patient panel. Evaluate the impact of a Complex Care Program (CCP) on likelihood of patient survival and hospital admission in 180 days following empanelment to the CCP. Retrospective cohort study using a quasi-experimental design with CCP patients propensity score matched to a concurrent control group of eligible but unempaneled patients. Kaiser Permanente Mid-Atlantic States (KPMAS) during 2017-2018. Nine hundred twenty-nine CCP patients empaneled January 2017-June 2018, 929 matched control patients for the same period. The KPMAS CCP is a new program consisting of 8 teams each staffed by a physician and nurse who coordinate care across a continuum of specialty care, tertiary care, and community services for a panel of 200 patients with advanced clinical disease and recent hospitalizations. Time to death and time to first hospital admission in the 180 days following empanelment or eligibility. Compared to matched control patients, CCP patients had prolonged time to death (hazard ratio [HR]: 0.577, 95% CI: 0.474, 0.704), and CCP decedents had longer survival (median days 69.5 vs. 53.0, p=0.03). CCP patients had similar time to hospital admission (HR: 1.081, 95% CI: 0.930, 1.258), with similar results when adjusting for competing risk of death (HR: 1.062, 95% CI: 0.914, 1.084). Non-randomized intervention; single healthcare system; patient eligibility limited to specific conditions. The KPMAS CCP was associated with significantly reduced short-term mortality risk for eligible patients who volunteered to participate in this intervention.

Combination of umbilical cord mesenchymal stem cells and standard immunosuppressive regimen for pediatric patients with severe aplastic anemia

BackgroundDefects of bone marrow mesenchymal stem cells (BM-MSCs) in proliferation and differentiation are involved in the pathophysiology of aplastic anemia (AA). Infusion of umbilical cord mesenchymal stem cells (UC-MSCs) may improve the efficacy of immunosuppressive therapy (IST) in childhood severe aplastic anemia (SAA).MethodsWe conducted an investigator-initiated, open-label, and prospective phase IV trial to evaluate the safety and efficacy of combination of allogenic UC-MSCs and standard IST for pediatric patients with newly diagnosed SAA. In mesenchymal stem cells (MSC) group, UC-MSCs were injected intravenously at a dose of 1 × 106/kg per week starting on the 14th day after administration of rabbit antithymocyte globulin (ATG), for a total of 3 weeks. The clinical outcomes and adverse events of patients with UC-MSCs infusion were assessed when compared with a concurrent control group in which patients received standard IST alone.ResultsNine patients with a median age of 4 years were enrolled as the group with MSC, while the data of another 9 childhood SAA were analysed as the controls. Four (44%) patients in MSC group developed anaphylactic reactions which were associated with rabbit ATG. When compared with the controls, neither the improvement of blood cell counts, nor the change of T-lymphocytes after IST reached statistical significance in MSC group (both p > 0.05) and there were one (11%) patient in MSC group and two (22%) patients in the controls achieved partial response (PR) at 90 days after IST. After a median follow-up of 48 months, there was no clone evolution occurring in both groups. The 4-year estimated overall survival (OS) rate in two groups were both 88.9% ± 10.5%, while the 4-year estimated failure-free survival (FFS) rate in MSC group was lower than that in the controls (38.1% ± 17.2% vs. 66.7% ± 15.7%, p = 0.153).ConclusionsConcomitant use of IST and UC-MSCs in SAA children is safe but may not necessarily improve the early response rate and long-term outcomes. This clinical trial was registered at ClinicalTrials.gov, identifier: NCT02218437 (registered October 2013).

Sleep disturbances in children with functional gastrointestinal disorders: demographic and clinical characteristics.

Research indicates a deleterious effect of sleep disturbances on pain and illness-related functioning across pediatric populations. Sleep problems in youth with functional gastrointestinal disorders (FGIDs) are understudied, despite studies in adult FGIDs indicating sleep disruptions increase pain and symptom severity. This study sought to better characterize sleep problems in school-age children with FGIDs and to assess relationships with demographic characteristics and gastrointestinal symptoms. Sixty-seven children with FGIDs (pediatric Rome IV criteria) and 59 parents completed questionnaires assessing sleep problems, and children completed a 2-week pain/stooling diary. Sleep problems in this sample were compared with published normative samples, and children above and below the clinical cutoff were compared on demographics and FGID symptoms. Of the sample, 61% were above the clinical cutoff for sleep disturbances, with significantly greater bedtime resistance, sleep onset delay, sleep duration, and daytime sleepiness than the comparison group. Children above the clinical cutoff reported greater mean abdominal pain severity and pain interference. Relative to White participants, Black/African-American participants were more likely to be above the clinical cutoff and indicated more frequent night wakening and symptoms of sleep-disordered breathing, but lower maximum and overall mean abdominal pain severity. Sleep problems in children with FGIDs are common and related to greater day-to-day abdominal pain severity and pain interference. Results suggest sleep-pain relationships may differ across racial/ethnic groups. Assessing sleep in children with FGIDs is important, and further research is needed to assess underlying mechanisms and evaluate sleep as a potential treatment target in this population.

The Effect of Unsupervised Home-Based Exercise Training on Physical Functioning Outcomes in Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Exercise training such as balance, aerobic, and resistance training is able to improve physical functioning of older adults. Delivering such exercise regimes at home without supervision may be useful for older adults because they do not have to leave their homes. This systematic review and meta-analysis of randomized controlled trials aimed to establish the effect of unsupervised home-based exercise training regimes on physical functioning (balance and muscle strength) in older adults. PubMed, CINAHL, Medline, Google Scholar, and Scopus databases and reference lists of included investigations were searched. Thirteen randomized controlled trials (RCTs) of exercise training impact on balance and upper body strength with concurrent control groups were included in the analysis. Our analyses revealed that in older adults, unsupervised home-based various exercise training was effective in improving measures of proactive balance (mean difference (MD) = -1.37 s; 95% confidence interval (CI), -2.24, -0.51 s; p = 0.002) and balance test battery (MD: 1.80; 95% CI, 0.46, 3.14 s; p = 0.009). There were no significant differences between the experimental and control groups for upper body strength (p > 0.05). Unsupervised home-based exercise training improves balance in older adults. Future investigations are needed to clarify the mechanisms underlying unsupervised home-based exercise training's effect on this population's physical functioning outcomes.

A Longitudinal Measure of Medical Student Empathy at a Regional Campus

Introduction Empathy is an important characteristic of the ideal physician. Various quantitative measures of empathy have shown a steep decline during the third year of medical school. Methods We had 4 classes of medical students at our regional rural campus complete the Jefferson Scale of Empathy after each of the first 3 years. We report longitudinal results of 30 students, individually matched, including an analysis by gender. Separately, we report the cross-sectional results for 39 of our students as they began medical school. We compare our student scores to other allopathic and osteopathic student scores from large urban campuses. The Baptist Health Madisonville IRB approved the protocol as exempt. Results As they begin medical school, our students have similar scores to those at large urban campuses (difference of 1.1 points, p=.421). After the M-2 year, our students had significantly higher scores than those at urban campuses (5.7 points, p=.002) and after the M-3 year, they show an even larger positive difference (9.0 points, p<.001). As in previous publications, females had higher overall mean scores at each measure, but with our students this was only significant in post-M-2 measures (8.9 points, p=.01). Discussion We conclude that something about our students’ experience during their M-3 year is associated with a smaller decline in empathy measures than reported previously. We propose that some of this difference could be due to a formal professional identity curriculum we implemented recently during the M-3 year. However, without a concurrent or historical control group, we cannot be certain. We offer the concept of measuring empathy before and after curricular change as another useful evaluation tool for medical educators.

Sample size calculation for active-arm trial with counterfactual incidence based on recency assay.

The past decade has seen tremendous progress in the development of biomedical agents that are effective as pre-exposure prophylaxis (PrEP) for HIV prevention. To expand the choice of products and delivery methods, new medications and delivery methods are under development. Future trials of non-inferiority, given the high efficacy of ARV-based PrEP products as they become current or future standard of care, would require a large number of participants and long follow-up time that may not be feasible. This motivates the construction of a counterfactual estimate that approximates incidence for a randomized concurrent control group receiving no PrEP. We propose an approach that is to enroll a cohort of prospective PrEP users and aug-ment screening for HIV with laboratory markers of duration of HIV infection to indicate recent infections. We discuss the assumptions under which these data would yield an estimate of the counterfactual HIV incidence and develop sample size and power calculations for comparisons to incidence observed on an investigational PrEP agent. We consider two hypothetical trials for men who have sex with men (MSM) and transgender women (TGW) from different regions and young women in sub-Saharan Africa. The calculated sample sizes are reasonable and yield desirable power in simulation studies. Future one-arm trials with counterfactual placebo incidence based on a recency assay can be conducted with reasonable total screening sample sizes and adequate power to determine treatment efficacy.

Headache at onset of first‐ever ischemic stroke: Clinical characteristics and predictors

No studies have prospectively investigated headache at onset of first-ever ischemic stroke along with a large concurrent control group. Our aims were to answer two important questions: (i) Are headaches at stroke onset causally related to the stroke, and what are their typical clinical characteristics? (ii) What etiology of stroke is associated with these headaches? The study population consisted of 550 patients (mean age=63.1, 54% males) with first-ever ischemic stroke and 192 control patients (mean age=58.7, 36% males) admitted to the emergency room without any acute neurological deficits or serious disorders. All data were collected prospectively, using a standardized case-report form during face-to-face interviews by neurologists. Headache at onset of ischemic stroke was present in 82 (14.9%) of 550 patients. More than half (56%) had a new type of headache (mainly migraine-like) simultaneously with stroke onset, and 36% had headache with altered characteristics (mainly tension-type-like headache). Headaches were associated with cardioembolism (p=0.002, odds ratio [OR]=2.4, 95% confidence interval [CI]=1.4-4.1), posterior circulation stroke (p=0.01, OR=2.0, 95% CI=1.2-3.5), infarcts >15mm (p=0.03, 95% CI=1.1-2.7), infarcts of the cerebellum (p=0.02, OR=2.3, 95% CI=1.1-4.8), good neurological status (p=0.01, OR=2.5, 95% CI=1.2-4.9), and low frequency of large-artery atherosclerosis (p=0.004, OR=0.4, 95% CI=0.2-0.8). At stroke onset, headache of a new type and headache with altered characteristics were related to ischemic stroke. They were associated with certain etiologies of stroke.

Nutrition Care for Poorly Nourished Outpatients Reduces Resource Use and Lowers Costs.

Background and Objectives:Over 25% of United States (US) community-dwelling, older adults are at nutritional risk. Health and cost burdens of poor nutrition can be lowered by nutrition programs for hospital inpatients, but few studies have looked at the impact on outpatients. The objective of our study was to assess outcomes of a nutrition focused quality improvement program (QIP) on healthcare resource use and costs in poorly nourished outpatients.Methods:This pre-post QIP study was implemented at 3 US healthcare system clinics. Included patients (n = 600) were ≥45 years old, had ≥2 chronic conditions, and were enrolled over a 15-month interval. For comparison, historical (n = 600) and concurrent control (n = 600) groups were used. Assessment of poor nutritional status was performed during each patient’s baseline visit. Healthcare resource use (hospitalizations, emergency department visits, and outpatient clinic visits), medication use, and costs were determined for a 90-day interval.Results:QIP patients (mean age 61.6 years) were predominantly female (62.5%) and overweight/obese (81.7%). The proportion of QIP outpatients presenting for healthcare services was significantly reduced compared to both historical and concurrent controls—relative risk reduction (RRR) versus historical (11.6%, P < .001) and versus concurrent (8.9%, P = .003). Of those who presented, RRR for healthcare resource use by QIP was significant in comparison with historical (12.9%, P = .022) but not concurrent controls. No significant differences were observed for medication usage. Lower resource use among QIP patients yielded total cost savings of $290 923 or per-patient savings of $485.Conclusions:Nutrition QIPs in outpatient clinics are feasible and can reduce healthcare resource use and cut costs. Such findings underscore benefits of nutritional interventions for community-dwelling outpatients with poor nutritional status.

Buchholzia coriacea (wonderful kola) seeds induce male reproductive toxicity by suppressing the pituitary-gonadal axis in Wistar rats

The methanolic extract of Buchholzia coriacea seeds (MEBC) has been reported to induce male reproductive toxicity by decreasing sperm parameters and fertility index. To elucidate the possible mechanism(s), the effects of graded doses of MEBC on sex hormones and sperm profile were investigated in this study. The MEBC (e.g., 50, 200, 400, and 600 mg/kg) was administered daily (p.o.) to male Wistar rats for 6 weeks, while a concurrent control group received distilled water (vehicle). Then, the animals were sacrificed under sodium pentobarbital anaesthesia. Weights of organs were recorded, and the sperm profile was determined microscopically. Testosterone, luteinizing hormone (LH), and follicle stimulating hormone (FSH) were assayed from the obtained serum using the ELISA technique. Sperm motility was significantly reduced by MEBC (i.e., 50 and 200 mg/kg), and sperm count reduced in all treated groups in a dose-dependent manner compared with that of the control. Serum testosterone, LH, and FSH decreased in treated rats. A histopathological examination of testes showed a considerable depletion and necrosis of the epithelium of seminiferous tubules. The result suggests that Buchholzia coriacea seeds induce male reproductive toxicity by suppressing the pituitary-gonadal axis.

Rapid Cycle Deliberate Practice Simulation Curriculum Improves Pediatric Trauma Performance: A Prospective Cohort Study.

Simulation-based medical education allows learners to refine and maintain clinical skills especially for high-stake situations such as trauma resuscitation. Despite the primary and secondary survey being its foundation, literature shows poor adherence with overall rates as low as 13%. This study evaluates the impact of rapid cycle deliberate practice (RCDP) on primary and secondary survey skill retention. We hypothesized that RCDP-trained surgery residents will have real-world clinical improvement in their survey completion in pediatric trauma resuscitations. We developed an RCDP trauma resuscitation curriculum. Videos of trauma resuscitations before and after curriculum implementation were scored by 2 blinded reviewers using a modified Pediatric Trauma Assessment Scoring Tool. Actual trauma care by residents who had received the curriculum (study group) was compared with care provided by residents who had not received the curriculum (precurriculum historical control group and a concurrent control group who provided care without receiving the curriculum). One hundred eighty-eight videos were scored with 98 in study group, 33 in concurrent control group, and 57 in historical control group. There was a significant improvement in primary survey performance between study group and historical control group (P < 0.001), but no difference between study group and concurrent control group. There was a significant improvement between study group and 2 control groups in secondary survey performance (both P < 0.001). The RCDP curriculum led to significant improvement in surgical residents' trauma survey performance and had clinical impact on actual patients, which is rare in pediatric trauma simulation literature.

Candida-Acinetobacter-Pseudomonas Interaction Modelled within 286 ICU Infection Prevention Studies.

Background: Whether Candida interacts to enhance the invasive potential of Acinetobacter and Pseudomonas bacteria cannot be resolved within individual studies. There are several anti-septic, antibiotic, anti-fungal, and non-decontamination-based interventions to prevent ICU acquired infection. These effective prevention interventions would be expected to variably impact Candida colonization. The collective observations within control and intervention groups from numerous ICU infection prevention studies simulates a multi-centre natural experiment with which to evaluate Candida, Acinetobacter and Pseudomonas interaction (CAPI). Methods: Eight Candidate-generalized structural equation models (GSEM), with Candida, Pseudomonas and Acinetobacter colonization as latent variables, were confronted with blood culture and respiratory tract isolate data derived from >400 groups derived from 286 infection prevention studies. Results: Introducing an interaction term between Candida colonization and each of Pseudomonas and Acinetobacter colonization improved model fit in each case. The size of the coefficients (and 95% confidence intervals) for these interaction terms in the optimal Pseudomonas (+0.33; 0.22 to 0.45) and Acinetobacter models (+0.32; 0.01 to 0.5) were similar to each other and similar in magnitude, but contrary in direction, to the coefficient for exposure to topical antibiotic prophylaxis (TAP) on Pseudomonas colonization (−0.45; −0.71 to −0.2). The coefficient for exposure to topical antibiotic prophylaxis on Acinetobacter colonization was not significant. Conclusions: GSEM modelling of published ICU infection prevention data supports the CAPI concept. The CAPI model could account for some paradoxically high Acinetobacter and Pseudomonas infection incidences, most apparent among the concurrent control groups of TAP studies.

An Implementation-Effectiveness Study of a Perioperative Delirium Prevention Initiative for Older Adults.

Postoperative delirium is a common and serious problem for older adults. To better align local practices with delirium prevention consensus guidelines, we implemented a 5-component intervention followed by a quality improvement (QI) project at our institution. This hybrid implementation-effectiveness study took place at 2 adult hospitals within a tertiary care academic health care system. We implemented a 5-component intervention: preoperative delirium risk stratification, multidisciplinary education, written memory aids, delirium prevention postanesthesia care unit (PACU) orderset, and electronic health record enhancements between December 1, 2017 and June 30, 2018. This was followed by a department-wide QI project to increase uptake of the intervention from July 1, 2018 to June 30, 2019. We tracked process outcomes during the QI period, including frequency of preoperative delirium risk screening, percentage of "high-risk" screens, and frequency of appropriate PACU orderset use. We measured practice change after the interventions using interrupted time series analysis of perioperative medication prescribing practices during baseline (December 1, 2016 to November 30, 2017), intervention (December 1, 2017 to June 30, 2018), and QI (July 1, 2018 to June 30, 2019) periods. Participants were consecutive older patients (≥65 years of age) who underwent surgery during the above timeframes and received care in the PACU, compared to a concurrent control group <65 years of age. The a priori primary outcome was a composite of perioperative American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use (Beers PIM) medications. The secondary outcome, delirium incidence, was measured in the subset of older patients who were admitted to the hospital for at least 1 night. During the 12-month QI period, preoperative delirium risk stratification improved from 67% (714 of 1068 patients) in month 1 to 83% in month 12 (776 of 931 patients). Forty percent of patients were stratified as "high risk" during the 12-month period (4246 of 10,494 patients). Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12. We analyzed medication use in 7212, 4416, and 8311 PACU care episodes during the baseline, intervention, and QI periods, respectively. Beers PIM administration decreased from 33% to 27% to 23% during the 3 time periods, with adjusted odds ratio (aOR) 0.97 (95% confidence interval [CI], 0.95-0.998; P = .03) per month during the QI period in comparison to baseline. Delirium incidence was 7.5%, 9.2%, and 8.5% during the 3 time periods with aOR of delirium of 0.98 (95% CI, 0.91-1.05, P = .52) per month during the QI period in comparison to baseline. A perioperative delirium prevention intervention was associated with reduced administration of Beers PIMs to older adults.

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression.

Nonpharmacological and accessible therapies that engage individuals in self-management are needed to address depressive symptoms in pregnancy. The 12-week "Mindful Moms" intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful physical activity using prenatal yoga. This longitudinal pilot study evaluated the feasibility, acceptability, and preliminary effects of the "Mindful Moms" intervention in pregnant women with depressive symptoms. We evaluated enrollment and retention data (feasibility) and conducted semistructured interviews (acceptability). We evaluated the intervention's effects over time on participants' depressive symptoms, anxiety, perceived stress, self-efficacy, and maternal-child attachment, and we compared findings to an archival comparison group, also assessed longitudinally. Enrollment and retention rates and positive feedback from participants support the intervention's acceptability and feasibility. "Mindful Moms" participants experienced decreases in depressive symptoms, perceived stress, anxiety, ruminations, and maternal-child attachment and no change in physical activity self-efficacy from baseline to postintervention. Comparisons of the "Mindful Moms" intervention to the comparison groups over time indicated differences in depressive symptoms between all groups and a trend in differences in perceived stress. Results support the feasibility and acceptability of "Mindful Moms" for pregnant women with depressive symptoms and suggest that further research is warranted to evaluate this intervention for reducing depressive and related symptoms. Lack of a concurrent control group, with equivalent attention from study staff, and no randomization limit the generalizability of this study; yet, these preliminary findings support future large-scale randomized controlled trials to further evaluate this promising intervention.

System-Wide Accelerated Implementation of Telemedicine in Response to COVID-19: Mixed Methods Evaluation

BackgroundAs the COVID-19 pandemic disrupted medical practice, telemedicine emerged as an alternative to outpatient visits. However, it is not known how patients and physicians responded to an accelerated implementation of this model of medical care.ObjectiveThe aim of this study is to report the system-wide accelerated implementation of telemedicine, compare patient satisfaction between telemedicine and in-person visits, and report provider perceptions.MethodsThis study was conducted at the UC Christus Health Network, a large private academic health network in Santiago, Chile. The satisfaction of patients receiving telemedicine care in March and April 2020 was compared to those receiving in-person care during the same period (concurrent control group) as well as in March and April 2019 (retrospective control group). Patient satisfaction with in-person care was measured using the Net Promoter Score (NPS) survey. Patient satisfaction with telemedicine was assessed with an online survey assessing similar domains. Providers rated their satisfaction and responded to open-ended questions assessing challenges, strategies used to address challenges, the diagnostic process, treatment, and the patient-provider relationship.ResultsA total of 3962 patients receiving telemedicine, 1187 patients from the concurrent control group, and 1848 patients from the retrospective control group completed the surveys. Satisfaction was very high with both telemedicine and in-person services. Overall, 263 physicians from over 41 specialties responded to the survey. During telemedicine visits, most providers felt their clinical skills were challenged (61.8%). Female providers felt more challenged than male providers (70.7% versus 50.9%, P=.002). Surgeons, obstetricians, and gynecologists felt their clinical skills were challenged the least, compared to providers from nonsurgical specialties (P<.001). Challenges related to the delivery modality, diagnostic process, and patient-provider relationship differed by provider specialty (P=.046, P<.001, and P=.02, respectively).ConclusionsTelemedicine implemented in response to the COVID-19 pandemic produced high patient and provider satisfaction. Specialty groups perceived the impact of this new mode of clinical practice differently.

Anti-Inflammatory Effects of Exercise on Metabolic Syndrome Patients: A Systematic Review and Meta-Analysis.

Increments in inflammatory indicators and low levels of physical activity are correlated to the expansion of the metabolic syndrome (MetS). The purpose of this study was to establish if exercise training ameliorates inflammatory status in MetS patients. PubMed, CINAHL, and Medline, Google Scholar, and Scopus databases and reference lists of included studies were searched. Twenty randomized controlled trials (RCTs) of exercise-training impact on inflammatory markers (tumor necrosis factor (TNF) α, C-reactive protein (CRP), interleukin (IL) 6, IL-8, IL-10, and IL-18) with concurrent control groups were included in this analysis. Results demonstrated an overall significant decrease in serum levels of TNF-α (mean difference (MD): -1.21 pg/ml; 95% confidence interval (CI): -1.77, -0.66), CRP (MD: -0.52 mg/l; 95% CI: -0.79, -0.25), IL-8 (MD: -1.31 pg/ml; 95% CI: -2.57, -0.06), and a significant increase in IL-10 (MD: 0.48 pg/ml; 95% CI: 0.10, 0.86). But exercise training did not change the level of IL-6 (MD: -0.69 pg/ml; 95% CI: -1.53, 0.14) and IL-18 (MD: -53.01 pg/ml; 95% CI: -166.64, 60.62). Exercise training improves TNF-α, CRP, IL-8, and IL-10 levels in patients with MetS. For some variables, isolated aerobic exercise, and combined aerobic and resistance exercise appears to be optimal. Future research is needed to clarify the mechanisms underlying exercise training's effect on this population's inflammatory markers. More studies are required to confirm these findings.

Implementing High-Reliability Organization Principles Into Practice: A Rapid Evidence Review.

To promote a safety culture and reduce harm, health care systems are adopting high-reliability organization (HRO) principles. This rapid review synthesizes HRO frameworks, metrics, and implementation effects to help inform health systems' efforts toward becoming HROs. Bibliographic databases were searched from 2010 to 2019. One reviewer used prespecified criteria to assess articles for inclusion, evaluate study quality, extract data, and grade strength of evidence with second reviewer checking. Twenty-three articles were identified: 8 described frameworks, 9 examined metrics, and 9 evaluated implementation outcomes. Five common strategies for HRO implementation emerged (developing leadership, supporting a culture of safety, providing training and learning, building data systems, and implementing quality improvement interventions). The Joint Commission's and Institute for Healthcare Improvement's frameworks emerged as the most comprehensive and widely applicable. The Joint Commission's Oro 2.0 metric for evaluating HRO progress similarly stood out as it was developed through broad stakeholder input and was validated by external researchers. Multicomponent HRO interventions delivered for at least 2 years were associated with improved process and patient safety outcomes. Because each HRO intervention was only supported by a single poor or fair-quality study-none of which contained a concurrent control group-a causal relationship between any HRO initiative and outcomes could not be established. Health care system adoption of HRO principles is associated with improved safety outcomes, yet the level of evidence is low. Priorities for future HRO studies include use of concurrent control groups and examination of specific outcomes measurements.