Outcomes of Different Perioperative Management Strategies of Patients on Chronic Anticoagulation in Elective Total Hip and Knee Arthroplasty
Different anticoagulation-related perioperative management strategies achieve different outcomes following elective arthroplasty in patients with therapeutic chronic anticoagulation. There is contradictory evidence regarding the need for the discontinuation of therapeutic warfarin. Retrospective data showed that individual risk stratification with multi-modal prophylaxis resulted in minimal complications.
KEY FINDINGS: Different anticoagulation-related perioperative management strategies achieve different outcomes following elective arthroplasty in patients with therapeutic chronic anticoagulation. There is contradictory evidence regarding the need for the discontinuation of therapeutic warfarin. Retrospective data showed that individual risk stratification with multi-modal prophylaxis resulted in minimal complications.
BACKGROUND: There are currently different management guidelines for patients undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA) that are on long-term anticoagulation. The timing of discontinuation and restarting the anticoagulation is challenging during the postoperative care, which often involves general practitioners and physiotherapists.
DETAILS: The systematic review followed the PRISMA guidelines and included 3 databases: PubMed/MEDLINE, EMBASE, and Web of Science Core Collection. The risk of bias assessment was performed using the Methodological index for non-randomized studies (MINORS) criteria. Six retrospective studies involving 727 patients with therapeutic anticoagulation (1,540 controls) for elective THA, TKA and revision arthroplasty have been included. The follow-up ranged from 30 days to 1 year postoperatively. All studies evaluated outcomes of warfarin therapeutic anticoagulation versus prophylactic dosages of one or more of the following: warfarin, aspirin, low-molecular-weight heparin (LMWH) and unfractionated low-dose heparin (UFH). One study did not discontinue therapeutic anticoagulation. Two studies reported no significant differences in complications between groups, whilst 3 studies had significantly higher rates of superficial wound infections, revision surgeries, postoperative haematomas, and prosthetic joint infections (PJI).
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Source: Andronic, D., Andronic, O., Ammann, E., et al. (2024). Outcomes of Different Perioperative Management Strategies of Patients on Chronic Anticoagulation in Elective Total Hip and Knee Arthroplasty: A Systematic Review. Family Practice. 2024; 41(5): 629–637. Published: October, 2024. DOI: 10.1093/fampra/cmae020.
Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis
The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care.
KEY FINDINGS: The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care.
BACKGROUND: Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis–associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure.
DETAILS: This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks. A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of -2.6 recurrences per person-year (95% CI, -4.0 to -1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.
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Source: Vodstrcil, L. A., Plummer, E. L., Firley, C. K., et al. (2024). Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis. NEJM. 2025; 392(10): 947-957. Published: March 5, 2025. DOI: 10.1056/NEJMoa2405404.
Pulse Oximetry and Skin Tone in Children
The POSTer-Child study by Vanderbilt University Medical Center reveals that pulse oximetry may overvalue oxygen saturation in pediatric patients with darker skin tones, leading to undertreatment of hypoxemia.
KEY FINDINGS: Authors report a prospective study involving children that showed overestimation of saturation by pulse oximetry that was attributable to skin tone. This overestimation could lead to undertreatment of hypoxemia and contribute to racial inequities in outcomes. Additional studies are needed in populations with a greater proportion of persons with darker skin tone. The findings emphasize that current FDA guidance for pulse-oximeter validation (https://www.fda.gov/media/72470/download?attachment), which recommends only limited involvement of persons with darkly pigmented skin without a formal definition, is inadequate in ensuring equity in pulse-oximetry accuracy. New guidance is currently under consideration. On the basis of these results, there is potential for improvement in both bias and precision.
BACKGROUND: Findings from the Pulse Oximetry and Skin Tone in Children (POSTer-Child) study were published February 12, 2025 in a letter to the editor of The New England Journal of Medicine. First author Joseph Starnes, MD, MPH, is a fellow in Pediatric Cardiology.
DETAILS: Retrospective studies have shown overestimation of oxygen saturation by pulse oximetry in adult and pediatric patients from races that may be associated with darker skin. These retrospective studies share key limitations, including race as a poor surrogate for skin tone and paired measurements of oxygen saturation as assessed by pulse oximetry (SpO2) and of arterial oxygen saturation (SaO2) in the medical record. Limited prospective laboratory-based and clinical studies that used measured skin tone in adults have shown worse pulse-oximeter performance among patients with darker skin than among those with lighter skin. Very few prospective studies have involved children.
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In the Pulse Oximetry and Skin Tone in Children (POSTer-Child) study, authors enrolled 320 patients younger than 21 years of age undergoing cardiac catheterization in 2024. Skin tone was measured with the use of a spectrophotometer. SpO2 was recorded with the use of two pulse oximeters (Nellcor and Masimo) at the exact time of blood sampling for measurement of fractional saturation by co-oximetry. Pulse-oximetry bias (SpO2-SaO2), precision (standard deviation of bias), and accuracy root mean square error (ARMS) were calculated (for all three measures, higher values indicate worse pulse-oximeter performance), as was the percentage of patients with occult hypoxemia (SaO2 of <88% when SpO2 is >=92%). Additional methodologic details are provided in the Supplementary Appendix, available with the full text of this letter at NEJM.org. The population was similar to the U.S. population but showed relative underrepresentation of Hispanic children. A total of 48 of 319 patients (15.0%) identified as Black, and 44 (13.8%) identified as Hispanic.
Average bias was 1.32 percentage points for the Nellcor device and 1.88 percentage points for the Masimo device. Bias was higher among children with darker skin (individual typology angle [ITA] category 5 or 6) than among those with lighter skin (ITA category 1 or 2) for both pulse oximeters (P<0.001). Precision and ARMS were also higher for children with darker skin. ARMS was substantially higher than the Food and Drug Administration (FDA) cutoff of three for children in ITA category 5 or 6. Occult hypoxemia was present in 4 of 56 children (7%) in ITA category 5 or 6 for the Nellcor device and in 5 of 60 children (8%) for the Masimo device, as compared with 0 of 81 children and 3 of 88 children (3%), respectively, in ITA category 1 or 2.
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Source: Starnes, J., Welch, W., Henderson, C. C., et al. (2024). Pulse Oximetry and Skin Tone in Children. NEJM. 2025; 392: 1033-1034; Published: February 17, 2025. DOI: 10.1056/NEJMc2414937.
Global and Regional Causes of Maternal Deaths 2009-20
The findings highlight the need to strengthen key aspects of maternity care, including antenatal services that detect risks early in pregnancy and prevent severe complications; lifesaving obstetrics that can manage critical birth-related emergencies like haemorrhage or embolism, and postnatal care. Most maternal deaths occur during or shortly after childbirth, making this a critical window to save lives.
KEY FINDINGS: Haemorrhage remains the leading cause of death, despite the existence of effective clinical interventions, emphasising the need for improved access to quality health care. The timing of most deaths in the postpartum period demands renewed commitment to improving the provision of postpartum care in addition to intrapartum care. Indirect causes of death require health system approaches to integrate obstetric and non-obstetric care.
BACKGROUND: Maternal mortality is not on track to meet Sustainable Development Goal (SDG) target 3.1 of a global maternal mortality ratio below 70 per 100,000 livebirths by 2030. Updated evidence on causes of death is needed to accelerate progress.
DETAILS: Authors conducted a multi-strategy systematic review to identify causes of maternal deaths occurring in 2009-20. Data sources included civil registration and vital statistics systems data from the WHO Mortality Database, reports published by Member States, and national and subnational journal articles identified via bibliographic databases. Authors used a Bayesian hierarchical model to estimate the maternal cause of death distribution by SDG regions and worldwide. Given the paucity of data on maternal suicide and late maternal deaths occurring beyond 42 days postpartum, additional analyses were conducted to estimate the proportion of maternal deaths from suicide and the ratio of maternal to late maternal deaths (all cause). Globally, the most common cause of maternal death was haemorrhage (27%; 80% uncertainty interval 22-32), followed by indirect obstetric deaths (23%, 18-30), and hypertensive disorders (16%, 14-19). The proportion of haemorrhage deaths varied substantially by region and was highest in sub-Saharan Africa and Western Asia and Northern Africa. The proportion of maternal deaths from hypertensive disorders was highest in Latin America and the Caribbean. Most maternal deaths from haemorrhage and sepsis occurred during the postpartum period. Only 12 countries recorded one or more maternal suicides; of those countries, the proportion of deaths from suicide ranged from below 1% to 26% of maternal deaths. For countries reporting at least one late maternal death (ie, deaths that occur more than 42 days but less than 1 year after the termination of pregnancy), the ratio of late maternal deaths to maternal deaths up to 42 days ranged from <0.01 to 0.07.
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Source: Cresswell, J. A., Alexander, M., Chong, M. Y. C., et al. (2024). Global and Regional Causes of Maternal Deaths 2009-20: A WHO Systematic Analysis. The Lancet Global Health. 2025; Published: March 5, 2025. DOI: 10.1016/S2214-109X(24)00560-6.
Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder
Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.
Summary
A Phase 3 Randomized Clinical Trial
[Posted 11/Mar/2025]
AUDIENCE: Psychiatry, Family Medicine, Nursing
KEY FINDINGS: Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.
BACKGROUND: New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD). Purpose of this study is to investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.
DETAILS: This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample). The primary end point was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events. A total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, -19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, -13.6 [1.2]; n = 134), with LS mean difference, -5.59 (95% CI, -8.79 to -2.38; P .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.
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Source: Davis, L. L., Behl, S., Lee, D., et al. (2024). Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial. JAMA Psychiatry. 2025; 82(3): 218-227. Published: March, 2025. DOI: 10.1001/jamapsychiatry.2024.3996.
The Benefits and Harms of Oral Iron Supplementation in Non-Anaemic Pregnant Women
Prophylactic iron supplementation likely results in a large reduction in maternal anaemia during pregnancy. Evidence surrounding the harms of iron supplementation in the non-anaemic population is poor quality and inconsistent. Randomized controlled trials quantifying the risk of gastrointestinal (GI) disturbance and iron overload are essential to inform iron supplement use and reduce unwarranted variations in international guidelines.
KEY FINDINGS: Prophylactic iron supplementation likely results in a large reduction in maternal anaemia during pregnancy. Future research should qualify the impact of this benefit on women's quality of life and determine which subpopulations benefit most. Evidence surrounding the harms of iron supplementation in the non-anaemic population is poor quality and inconsistent. Randomized controlled trials quantifying the risk of gastrointestinal (GI) disturbance and iron overload are essential to inform iron supplement use and reduce unwarranted variations in international guidelines.
BACKGROUND: Iron deficiency during pregnancy poses a significant risk to both maternal and foetal health. Current international guidelines provide discrepant advice on antenatal iron supplementation for non-anaemic women. Study was aimed to quantify the benefits and harms of routine antenatal supplementation in non-anaemic women.
DETAILS: The Cochrane Library, MEDLINE, Embase, and clinical trial registries were searched for randomized controlled trials and observational studies comparing oral iron supplementation with placebo or no supplement in non-anaemic pregnant women. Risk of bias was assessed for each study and the results were synthesized via meta-analysis. Twenty-three eligible studies were identified with 4492 non-anaemic pregnant women. Supplemented groups had higher haemoglobin [mean difference = 6.95 g/l, 95% confidence interval (CI): 4.81-9.09, P < .001, moderate certainty, I2 = 91%] and ferritin (mean difference = 12.22 ng/ml, 95% CI: 6.92-17.52, P < .001, moderate certainty, I2 = 87%) and were at lower risk of anaemia (relative risk = 0.50, 95% CI: 0.34-0.74, P < .001, high certainty, I2 = 42%, number needed to treat (NNT) = 10). There was no difference in birth weight, preterm birth, and rate of caesarean section. Reporting on harms was inconsistent and there was insufficient evidence to determine an association between iron supplements and any negative outcome.
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Source: Watt, A., Eaton, H., Eastwick-Jones, K., et al. (2024). The Benefits and Harms of Oral Iron Supplementation in Non-Anaemic Pregnant Women: A Systematic Review and Meta-Analysis. Family Practice . 2024; 42(1): cmae079. Published: February, 2025. DOI: 10.1093/fampra/cmae079.
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