Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials.

IMPORTANCE: Perioperative anemia is a common comorbid condition associated with increased risk of morbidity and mortality in patients undergoing elective surgical procedures. OBJECTIVE: We conducted a systematic literature review (SLR) to determine the efficacy and safety of the use of intravenous ferric carboxymaltose (FCM) for the treatment of perioperative anemia in preoperative, intraoperative, and postoperative elective surgical care. EVIDENCE REVIEW: Studies meeting inclusion criteria for the SLR reported on treatment efficacy in an adult study population randomly allocated to FCM for the treatment of perioperative anemia during the perioperative period. After screening, 10 of 181 identified studies from searches in MEDLINE and EMBASE databases were identified for inclusion in this review. FINDINGS: Preoperative treatment was reported in six studies, intraoperative treatment in one study, postoperative treatment in two studies, and both pre- and postoperative treatment in one study. Together, 1975 patients were studied, of whom 943 were randomized to FCM, of whom 914 received FCM treatment. The 10 studies reported elective surgical populations for colorectal, gastric, orthopedic, abdominal, urologic, plastic, neck, gynecologic, and otolaryngologic procedures. Given the clinical and methodological heterogeneity of the studies, the analyses were limited to qualitative assessments without meta-analyses. All 10 studies reported statistically greater changes in hemoglobin concentration, serum ferritin, and/or transferrin saturation with FCM treatment compared with comparators (placebo, oral iron, standard care, or a combination of these). Two studies reported statistically significant differences in transfusion rate and 2 studies reported significant differences in length of hospital stay between FCM and its comparator(s). CONCLUSIONS AND RELEVANCE: This SLR adds to existing data that administration of FCM in preoperative and postoperative settings improves hematologic parameters. Several studies in the review supported the beneficial effects of FCM in reducing transfusion rate and length of stay. Larger, well-designed, longer-term studies may be needed to further establish the efficacy and safety of FCM in elective surgery patients with perioperative anemia.

Using theory and user-centered design in digital health: The development of the mychoice communication tool to prepare patients and improve informed decision making regarding clinical trial participation.

OBJECTIVE: Designing salient digital health interventions requires theoretically-based formative research and user-center design with stakeholder input throughout impacting content and technology design. mychoice is a theory-based, stakeholder-guided digital health tool to improve clinical trial informed decision making, particularly among African American patients. METHODS: mychoice was developed by (1) mixed-methods formative research, including in-depth interviews (n=16) and surveys (N=41) with African American cancer patients who had and had not participated in a clinical trial; (2) e-tool design process including perceptual mapping analysis to prioritize messages, multi-disciplinary team and stakeholder input; and (3) iterative production and user testing. RESULTS: Interview findings showed that clinical trial participants expressed more positive attributes about and an openness to consider clinical trials, even though they expressed common concerns such as "fear of being a guinea pig". Survey results indicated that clinical trial participants expressed they had been given information to make the decision (P = .001), while those who had not more frequently reported (P > .001) that no one had talked to them about trials. Perceptual mapping indicated that values such as "helping find a cure" or "value to society" had little resonance to those who had not participated, providing message strategy for prototype development. User testing of the tool resulted in modifications; the most significant was the adaptation to a multi-cultural version. CONCLUSIONS: With the promise of digital health interventions, theory-guided, user-centered and best practice development is critical and mychoice serves as an example of the application of these principles.

Correlates to Human Papillomavirus Vaccination Status and Willingness to Vaccinate in Low-Income Philadelphia High School Students.

BACKGROUND: Little is known about the correlates of human papillomavirus (HPV) vaccination or willingness to be vaccinated in urban, minority adolescents. METHODS: Using responses to the 2013 Youth Risk Behavior Survey in Philadelphia, a random sample of high schools provided weighted data representing 20,941 9th to 12th graders. Stratified by either having had or willingness to have the vaccine, bivariate analysis with sexual behavior, preventive health behaviors, mental health, substance use, and demographic characteristics were examined and then multivariable regression models were developed to estimate significant correlates. RESULTS: Respondents were 52.3% female, 84.4% non-White, and 65.9% ≥16 years; 43% reported having had the HPV vaccine, and of those not vaccinated, 66% reported willingness to be vaccinated. Logistic regression models indicate that females (odds ratio [OR] = 3.12, p < .01) and those reporting human immunodeficiency virus (HIV) testing (OR = 2.10, p < .01) were more likely to be vaccinated. Those reporting condom use during last intercourse (OR = 0.40; p = .05) and current marijuana use (OR = 0.37; p = .03) were less likely to indicate willingness to be vaccinated. CONCLUSIONS: Important areas for intervention include addressing misconceptions or feelings of "immunity," especially for those using condoms. Understanding the correlation between HIV testing and HPV vaccination is also an important intervention opportunity for schools hoping to increase adolescent vaccination rates.

SHS-Related Pediatric Sick Visits are Linked to Maternal Depressive Symptoms among Low-Income African American Smokers: An Opportunity for Intervention in Pediatrics.

Maternal smoking and depressive symptoms are independently linked to poor child health outcomes. However, little is known about factors that may predict maternal depressive symptoms among low-income, African American maternal smokers - an understudied population with children known to have increased morbidity and mortality risks. The objective of this study was to test the hypothesis that secondhand smoke exposure (SHSe)-related pediatric sick visits are associated with significant maternal depressive symptoms among low-income, African American maternal smokers in the context of other depression-related factors. Prior to randomization in a behavioral counseling trial to reduce child SHSe, 307 maternal smokers in Philadelphia completed the CES-D and questionnaires measuring stressful events, nicotine dependence, social support, child health and demographics. CES-D was dichotomized at the clinical cutoff to differentiate mothers with significant vs. low depressive symptoms. Results from direct entry logistic regression demonstrated that maternal smokers reporting more than one SHSe-related sick visit (OR 1.38, p<.001), greater perceived life stress (OR 1.05, p<.001) and less social support (OR 0.82, p<.001) within the last 3 months were more likely to report significant depressive symptoms than mothers with fewer clinic visits, less stress, and greater social support. These results suggest opportunities for future hypothesis-driven evaluation, and exploration of intervention strategies in pediatric primary care. Maternal depression, smoking and child illness may present as a reciprocally-determined phenomenon that points to the potential utility of treating one chronic maternal condition to facilitate change in the other chronic condition, regardless of which primary presenting problem is addressed. Future longitudinal research could attempt to confirm this hypothesis.

Identifying potential adverse effects by patients' ratings: a proof-of-concept study of a novel approach.

OBJECTIVE: Methods to evaluate adverse effects of medications are significantly underdeveloped compared to those for efficacy. In this pilot proof-of-concept study, we preliminarily compared a novel approach-the Symptom Assessment Tool (SAT)-to a systematic and detailed assessment by a physician for identifying symptoms that were potentially adverse effects (sensitivity) and excluding symptoms that were unlikely to be adverse effects (specificity). METHODS: A symptom inventory and rating of symptom severity were completed before starting a psychotropic medication (or increasing its dose), and again 2 weeks later. Each symptom was systematically assessed by the patient-rated SAT and by a physician and was classified as either a potential or unlikely adverse effect. The primary analysis compared the classification of symptoms by the SAT to that by the physician. Potential adverse effects were also subcategorized as possible or probable adverse effects. RESULTS: A sample of 193 symptoms from 15 adults was evaluated, only 37.3% of which were considered potential adverse effects by the physician. Sensitivity of the SAT compared to physician's assessment was 90.3% for potential adverse effects and 97.5% for the subgroup of probable adverse effects. The SAT correctly identified 63.6% of the symptoms as unlikely adverse effects (specificity), and its negative predictive value was 91.7%. CONCLUSIONS: The SAT, appropriate for its intended use as a screening tool, had high sensitivity and moderate specificity and could present physicians with a limited number of potential adverse effects for further assessment and intervention. Further evaluation and refinement of this approach is warranted.

Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: a randomized, parallel group, open-label trial.

BACKGROUND: There is a paucity of controlled clinical data on the best initial therapy for treating patients with bipolar type II (BP II) major depressive episode (MDE). In this analysis, we examined the safety and antidepressant efficacy of short-term venlafaxine versus lithium monotherapy in rapid and non-rapid cycling patients with BP II MDE. We hypothesized that lithium would have superior efficacy to venlafaxine, with fewer syndromal and sub-syndromal hypomanic and mixed mood conversions in the rapid cycling BP II MDE patients. METHODS: Patients were randomized to monotherapy with either venlafaxine 37.5-375 mg daily or lithium 300-2100 mg daily for 12 weeks. The primary outcome measure was the 28-item Hamilton Depression Rating (HAM-D 28), with embedded 'typical' HAM-D 17 and 'atypical' HAM-D 17-R symptom scores. Secondary outcomes included the Young Mania Rating Scale (YMRS), clinical global impressions severity (CGI/S) and change (CGI/C) ratings, the proportion of responders (with > or =50% reduction in baseline HAM-D score) and remitters (with a final HAM-D score or =4 affective episodes per year). We did not employ a patient-recorded daily chrono-record to identify ultra-short mood conversions. The study used a randomized, parallel group, open-label design. CONCLUSION: These observations from this exploratory analysis suggest that venlafaxine monotherapy may be more effective than lithium monotherapy, with a similar mood conversion rate, in rapid and non-rapid cycling patients with BP II MDE. These data support prior observations that venlafaxine monotherapy may be effective initial treatment for BP II MDE.