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Pregnancy Outcomes With Exposure to Second-Generation Antipsychotics During the First Trimester

J Clin Psychiatry. 2022 Jun 8;83(4):21m14081. doi: 10.4088/JCP.21m14081.

ABSTRACT

Objective: To investigate the risk of major congenital malformations associated with exposure to second-generation antipsychotics (SGAs) in the first trimester.

Methods: Pregnant women who received consultation on drug exposure from the Japan Drug Information Institute in Pregnancy from October 2005 to December 2016 were asked to complete a questionnaire at 1 month after the expected delivery date. The questionnaire included items on pregnancy outcome, date of delivery, gestational age at delivery, malformations in the infant that were confirmed by the pediatrician’s report, and the following parameters at birth: height, weight, head circumference, and chest circumference. Odds ratios (ORs) for major congenital malformations among live-born children of pregnant women with SGA exposure during the first trimester (SGA group) relative to children of women not exposed to SGAs and medications known to be teratogenic (comparison group) were estimated using an inverse probability of treatment weighting approach.

Results: Of 404 women with SGA exposure during the first trimester, there were 351 live births, 3 stillbirths, 34 spontaneous abortions, and 16 elective abortions. The rate of major congenital malformations among live-born children was 0.9% (3/351) in the SGA group and 1.8% (70/3,899) in the comparison group. No statistically significant differences were observed in the adjusted OR for major congenital malformations (adjusted OR = 0.44; 95% CI, 0.12-1.48; P = .179).

Conclusions: SGA exposure during the first trimester is not associated with an increased risk of major congenital malformations. These findings might be reassuring for pregnant women who require SGAs.

PMID:35687862 | DOI:10.4088/JCP.21m14081

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Do Antiseptic Coated Sutures Reduce Colo-Colonic Anastomotic Leaks?

Surg Innov. 2022 Jun 10:15533506221106254. doi: 10.1177/15533506221106254. Online ahead of print.

ABSTRACT

BACKGROUND: Colorectal anastomotic leaks remain one of the most significant complications following colorectal surgery. Various interventions to reduce anastomotic leaks have been investigated, however few have resulted in a significant improvement. To date antiseptic coated monofilament sutures for sutured bowel anastomoses have not been assessed, hence this study was undertaken to investigate whether or not triclosan impregnated polydioxanone suture material (PDS) results in fewer anastomotic leaks.

METHODS: A rabbit colo-colonic anastomotic model was developed to compare the tensile strength and local inflammatory response between triclosan coated PDS and uncoated PDS.

RESULTS: Of the 42 anastomoses there were 4 (9.5%) leaks. Of the remaining 38 anastomoses neither the leak pressures, degree of bowel wall inflammation or fibrosis were statistically different (P = .11; .813 and .658 respectively) when comparing the two suture materials.

CONCLUSIONS: In an animal model, triclosan coated PDS is as safe as uncoated PDS in performing colo-colonic anastomosis.

PMID:35687856 | DOI:10.1177/15533506221106254

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Trends in Sexual Behavior and Sexually Transmitted Infections After Initiating Human Immunodeficiency Virus Pre-Exposure Prophylaxis in Men Who Have Sex with Men from Amsterdam, the Netherlands: A Longitudinal Exposure-Matched Study

AIDS Patient Care STDS. 2022 Jun;36(6):208-218. doi: 10.1089/apc.2021.0219.

ABSTRACT

Men who have sex with men (MSM) initiating human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) may increase condomless anal sex (CAS) and number of partners, and, consequently, more often acquire sexually transmitted infections (STIs). Using data from the Amsterdam Cohort Studies, we compared sexual behavior and STI among MSM after PrEP-initiation with controls not initiating PrEP. The MSM reported on sexual behavior and were tested for HIV, chlamydia, gonorrhea, and syphilis semi-annually. We matched MSM who initiated PrEP between January 1, 2015 and December 31, 2019 1:1 to MSM who did not use time-dependent propensity scores based on age, sexual behavior, and STI. Primary end-points were number of casual partners, and proportion with CAS and receptive CAS (rCAS) with casual partners, sexualized drug use (SDU), any STI, and anal STI. We modeled end-points during the 4 years before and 2 years after PrEP-initiation or matched PrEP-initiation timepoint by using logistic regression (dichotomous end-points) or negative binomial regression (count end-point), adjusted for calendar year. Two hundred twenty-eight out of the 858 (26.6%) MSM initiated PrEP. We matched 198 out of 228 (86.8%) to a control. Before PrEP-initiation, end-points increased over time in both groups, with no statistically significant difference. The odds of CAS, rCAS, and anal STI were on average higher after than before PrEP-initiation in PrEP initiators, whereas after versus before differences were not observed in controls. After PrEP-initiation, PrEP initiators had statistically significantly more casual partners, and higher odds of CAS, rCAS, SDU, any STI, and anal STI than controls. These findings support frequent STI screening and counseling in MSM using PrEP.

PMID:35687814 | DOI:10.1089/apc.2021.0219

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Matching-adjusted indirect comparison of phase 3 clinical trial outcomes: OC-01 (varenicline solution) nasal spray and cyclosporine a 0.05% ophthalmic emulsion for the treatment of dry eye disease

J Manag Care Spec Pharm. 2022 Jun 10:1-11. doi: 10.18553/jmcp.2022.22005. Online ahead of print.

ABSTRACT

BACKGROUND: Matching-adjusted indirect comparison (MAIC) is a validated and widely accepted statistical method that derives indirect comparisons between treatments when head-to-head studies have not been performed. OBJECTIVE: To compare the efficacy of OC-01 varenicline nasal spray (OC-01 VNS) 0.03 mg to cyclosporine A (CsA) 0.05% ophthalmic emulsion on tear production in patients with dry eye disease based on data from the respective phase 3 clinical trials using the MAIC technique. METHODS: Individual patient data were drawn from the phase 3 registry trial of OC-01 VNS; aggregate data were drawn from 2 phase 3 trials of CsA in the publicly available New Drug Application for CsA 0.05% ophthalmic emulsion (RESTASIS). Using unanchored MAIC methods, the individual patient data were weighted based on 4 clinically relevant baseline variables (age, race, sex, and baseline Schirmer test score [STS]) to produce a weighted OC-01 VNS dataset matched to the key demographics of the CsA dataset. Least-squares mean change from baseline in STS for OC-01 VNS was calculated using the identical analysis of variance model used to calculate the same value for CsA in the RESTASIS New Drug Application, which were then compared. Proportions of subjects with improvement of 10 mm or more from baseline in STS were compared in the weighted OC-01 VNS and CsA dataset. Time points available for comparisons were CsA trials at 3 and 6 months and OC-01 data at 2 and 4 weeks. RESULTS: Data from 511 subjects in the OC-01 VNS phase 3 trial and 585 in the CsA phase 3 trials were analyzed. The least-squares mean STS change from baseline for OC-01 VNS at 2 and 4 weeks was significantly higher than that for CsA at 3 and 6 months (P < 0.0001 for all comparisons). Mean STS improvements were approximately 6-7 mm for OC-01 VNS and approximately 1 mm for CsA. The proportion of subjects with improvement of 10 mm or more from baseline in STS was significantly higher for OC-01 VNS (50.2%) than CsA (11.7 and 17.1% in the 2 CsA studies; P < 0.0001 for both comparisons). CONCLUSIONS: This MAIC analysis demonstrates OC-01 VNS produces significantly greater improvement in mean STS and results in significantly greater numbers of patients with substantial improvement in STS (percentage ≥ 10 mm) compared with CsA. Together, absent more robust data from head-to-head trials, findings may suggest a potentially greater magnitude of improvement achieved with OC-01 VNS compared with CsA for the treatment of dry eye disease within conditions of the analysis methodology. DISCLOSURES: Dr Visco was a consultant for Novartis, Allergan, and Oyster Point, Inc. Ms Hendrix and Drs Macsai and Gibson are employees and shareholders for Oyster Point Pharma, Inc. Drs Sun and Tam participated in clinical research and received funding from Oyster Point Pharma, Inc. Oyster Point Pharma, Inc sponsored the Phase 3 OC-01 (varenicine solution) clinical study from which analysis data are obtained.

PMID:35687793 | DOI:10.18553/jmcp.2022.22005

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A bibliometric analysis of research on herbal medicine for obesity over the past 20 years

Medicine (Baltimore). 2022 Jun 10;101(23):e29240. doi: 10.1097/MD.0000000000029240.

ABSTRACT

BACKGROUND: The aim of this study was to analyze published papers on the use of herbal medicine in obesity research over the past 20 years using bibliometric methods and present an overview of global research trends.

METHODS: English articles on herbal medicine for obesity published from 2001 to 2020 were retrieved from the Web of Science Core Collection database using the search terms “herbal” AND “obesity”. Microsoft Office Excel was used to sort and analyze the statistical data. Bibliographic analysis and data visualization were performed using visualization of similarities viewer based on publication year, country of publication, journal, research area, author, affiliated institution, and keywords.

RESULTS: A total of 463 English articles were retrieved, and we observed a trend in which the number of publications on herbal medicine for obesity has gradually increased over the past 20 years. The most productive countries and research organizations in this field were Korea and Kyunghee University, respectively. Many papers have been published in research areas, such as pharmacology pharmacy and integrative complementary medicine, and the journals with the most published articles in this field were Journal of Ethnopharmacology and Evidence-Based Complementary and Alternative Medicine. The main research keywords formed 3 clusters, and keywords with the most occurrences were “obesity,” “adipose-tissue,” and “insulin resistance.”

CONCLUSION: This study presents an overview of the global research trend of herbal medicine for obesity from the bibliographic analysis. An increased understanding of the recently changing research topics provides a new perspective on future research directions. This study may help guide the research in the field of obesity in the future.

PMID:35687773 | DOI:10.1097/MD.0000000000029240

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Sacubitril/Valsartan for heart failure: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Jun 10;101(23):e29149. doi: 10.1097/MD.0000000000029149.

ABSTRACT

BACKGROUND: Sacubitril-valsartan has been shown to have superior effects over angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with heart failure (HF). However, the effects of sacubitril-valsartan have never been systematically evaluated. Therefore, we performed a protocol for systematic review and meta-analysis to evaluate the efficacy and safety of sacubitril-valsartan in patients with HF.

METHODS: We selected 8 databases, including PubMed, the Web of Science, Embase, Cochrane Library, the Chinese National Knowledge Infrastructure, the Chinese Science Journal Database, Wanfang Data, and the Chinese Biomedical Literature Database. The search time was from database establishment to March 2022. Two reviewers will screen the records and include quality studies according to inclusion criteria independently. Two reviewers will assess the risk of bias of the included studies by the “Risk of Bias Assessment Tool” of the Cochrane Handbook for randomized controlled trials. Statistical analysis will be performed with Review Manager software 5.3.

RESULTS: A synthesis of current evidence of sacubitril-valsartan for treating HF will be provided in this protocol.

CONCLUSION: The results of this study will provide a theoretical basis for the clinical use of sacubitril-valsartan to treat HF.

PMID:35687770 | DOI:10.1097/MD.0000000000029149

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The Impact of the Early COVID-19 Pandemic On Inpatient Clinical Experience for Physical Medicine and Rehabilitation Resident Physicians

Am J Phys Med Rehabil. 2022 Jun 8. doi: 10.1097/PHM.0000000000002055. Online ahead of print.

ABSTRACT

The objective of this retrospective, observational study was to quantitatively study the impact of the early COVID-19 pandemic on the inpatient clinical experience of Physical Medicine and Rehabilitation (PM&R) resident physicians in an inpatient rehabilitation facility (IRF) setting. Inpatient clinical experience as evidenced by admissions, rehabilitation diagnosis, medical emergencies, acute care transfers, and resident work hours from January to June 2019 (pre-pandemic) were compared January to June 2020 (immediately before and during pandemic). There was a statistically significant decrease in the mean daily admissions in April 2020 and a significant increase in medically complex admissions in June 2020, reflective of medical patterns due to the pandemic. There was a decrease in mean work hours during the pandemic, but no statistically significant difference in admission rate of other rehabilitation diagnoses, medical emergencies or transfers to acute care. This study demonstrates no substantial pandemic related impact on inpatient clinical experience for PM&R residents in the studied program.

PMID:35687755 | DOI:10.1097/PHM.0000000000002055

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Psychometrics of the Multiple Sclerosis and Magnetic Resonance Imaging Knowledge Patient Questionnaire: A Pilot Study

J Neurosci Nurs. 2022 Jun 6. doi: 10.1097/JNN.0000000000000658. Online ahead of print.

ABSTRACT

BACKGROUND: In the last few decades, the revised diagnostic criteria for multiple sclerosis (MS) and the development of numerous new MS therapies have created the possibility of early diagnosis and opportune MS management. However, these changes, and the mounting emphasis on patient choice and shared decision making, have not been accompanied by improvements in information provided to patients with MS (PwMS). Information provision for PwMS increases disease-related knowledge that may assist them in decision making and quality of life. The purpose of this study was to validate the Multiple Sclerosis and Magnetic Resonance Imaging Knowledge Questionnaire (MSMRIKQ) to improve patients’ shared decision-making capabilities. METHODS: In this methodological study, the instrument development process was completed in 4 stages using principles of measurement theory: (1) establishing a pool of items after patient and clinician panels’ review, (2) evaluating the validity of the scale-both face and content validity, (3) pilot testing the scale, and (4) post-pilot testing statistical analysis of items and scale reliability and validity. RESULTS: The 20-item instrument was finalized based on a panel of MS experts’ and patients’ comments. The final version of the MSMRIKQ was pilot tested with a sample of 46 PwMS. Face validity was established on all MSMRIKQ items. Individual item-level and scale-level content validity indices for universal agreement estimates were acceptable at item-level content validity index = 1 and scale-level content validity index = 1 for the 20 items. The Kuder-Richardson 20 reliability estimate for the entire scale was 0.58; the Kuder-Richardson 20 estimates for the subscales of MS and magnetic resonance imaging knowledge were 0.35 and 0.51, respectively. The split-half reliability with Spearman-Brown correction for the total scale was 0.60. The Poisson regression model was significant for predicting MS knowledge within this population. CONCLUSION: The MSMRIKQ is a basic knowledge instrument for clinical and research use.

PMID:35687725 | DOI:10.1097/JNN.0000000000000658

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Cardiac resynchronization therapy outcomes with left ventricular lead concordant with latest mechanical activation: A meta-analysis

Pacing Clin Electrophysiol. 2022 Jun 10. doi: 10.1111/pace.14549. Online ahead of print.

ABSTRACT

BACKGROUND: For cardiac resynchronization therapy (CRT), image-guided approaches targeting left ventricular (LV) lead placement at the site of latest mechanical activation had inconsistent outcomes. We examined evidence for improved CRT outcomes when LV lead placement concordant with latest mechanical activation occurred.

METHODS: A review of EMBASE and PubMed was performed for randomized controlled trials or prospective observational studies from October 2008 through October 2020 comparing outcomes with concordant versus discordant LV lead placement. Meta-analyses were performed to assess the association between concordance and death, death or heart (HF) hospitalization, ≥ 15% reduction in LV end systolic volume (LVESV), and changes in LVESV or ejection fraction (LVEF).

RESULTS: From 5,897 citations, 9 publications (8 studies) with 1355 patients were selected; 975 with a concordant LV lead and 380 with a discordant lead. Mean age was 66 to 68, 82% were male, and 64% had ischemic cardiomyopathy. Meta-analyses demonstrated a statistically significant reduction in death/HF hospitalization at 2 years (OR 0.38; 95% CI 0.16, 0.92) and LVESV at 6 months (mean difference [MD] -13.4%; 95% CI -6.7%, -20.0%), and an increase in LVEF (MD 4.03; 95% CI 0.77, 7.30) with the concordant LV lead. There were trends towards decreased death at 2 years (OR 0.49; 95% CI 0.19, 1.23) and ≥ 15% reduction in LVESV at 6 months (OR 3.81; 95% CI 0.24, 61.24) with concordant LV lead placement.

CONCLUSIONS: A concordant LV lead was associated with better CRT outcomes. Further study of feasible methods to achieve LV lead concordance is needed. This article is protected by copyright. All rights reserved.

PMID:35687711 | DOI:10.1111/pace.14549

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Application Effects of SBAR Communication Mode in ICU Nursing Physical Restraint Shift

Altern Ther Health Med. 2022 Jun 10:AT7430. Online ahead of print.

ABSTRACT

CONTEXT: Correct and effective handovers of patients’ information during shift changes can ensure patients’ safety and can help an incoming shift of nurses to continuously monitor patients’ psychological problems and avoid unnecessary physical restraints. Development of a standard procedure for handover of patients who have been physically restrained has important clinical significance related to the smooth continuation of nursing work and assurance of the quality of care.

OBJECTIVE: The study intended to investigate the clinical effects of the situation-background-assessment-recommendation (SBAR) communication mode on the quality of the information passed during shift changes about patients in intensive care units (ICUs) who had been physically restrained and to compare it to the clinical effects obtained using traditional methods of communication.

DESIGN: The study was a retrospective analysis of the process used by nurses who were passing patient’s information during shift changes when caring for patients who had been physically restrained.

SETTING: The study took place in an ICU at the Second Hospital of Hebei Medical University in Shijiazhuang, Hebei, China.

PARTICIPANTS: Participants were 21 nurses caring for 239 ICU patients under physical restraint at the Second Hospital.

INTERVENTION: Of the 239 patients, 118 had been hospitalized between March 1 and March 15, 2018 and were assigned to the control group, and 121 had been hospitalized between June 1 and June 15, 2018 and were assigned to the intervention group. An ICU Physical Restraint Handover Order was established according to the SBAR communication mode. The intervention group used the SBAR communication mode and the control group used the hospital’s routine communication mode for the physical restraint of a patient during a nursing shift.

OUTCOME MEASURES: The study measured the differences between the groups in the nurses’ passing rates based on standards for the use of physical restraints, the quality of handover of information during shift changes about patients under physical restraint, the quality of the documentation written by nurses about the physical restraint, and the nurses’ satisfaction with the handover of information during a shift change.

RESULTS: Among the patient, 112 in the intervention group (92.56%) and 92 in the control group (77.97%) were qualified for physical restraint. A statistically significant difference existed between the two groups in the passing rate for the use of physical restraints (P = .001). The quality score for the handovers during shift changes of patients under physical restraint in the intervention group was 95.46 ± 2.50 and for the control group was 91.08 ± 3.57, with the difference being statistically significant (P = .030). The quality score for the nursing documentation for the intervention group, at 97.21 ± 1.49, was higher than that of the control group, at 90.78 ± 3.42, and the difference was statistically significant (P < .001). The nurses’ satisfaction score for the intervention group, at 98.14 ± 1.01 was higher than that of the control group, at 92.57 ± 1.86, and the difference was statistically significant (P = .006).

CONCLUSIONS: The use of the SBAR communication mode to improve the information passed to nurses about patients under physical restraint during a shift change can improve the quality of the physical restraint and nurses’ satisfaction and has a better clinical-application effect than the traditional methods used during shift changes.

PMID:35687709