Understanding Transient Ischaemic Attack (TIA)

TIA is a complex medical diagnosis with multiple risk factors that may make the management complex and hence difficult for patients to undertake.

source: Family Practice

Summary

Understanding TIA: An Ethnographic Study of TIA Consultations

[Posted 15/Oct/2020]

AUDIENCE: Family Medicine, Internal Medicine

KEY FINDINGS: TIA is a complex medical diagnosis with multiple risk factors that may make the management complex and hence difficult for patients to undertake. Our findings found variability in the conduct, provision of information and patient understanding. Guidance on nationally agreed consultation framework may prove useful. Improved patient education may include individualized/sustained education utilizing multidisciplinary team members across family/primary and secondary care, video or greater online education and improved general public education.

BACKGROUND: Transient ischaemic attack (TIA) is a transient episode of neurological dysfunction. Rapid access TIA clinics have been set up as integrated ‘one-stop’ clinics that aim to investigate, diagnose, educate and implement treatment to reduce the risk of further TIA/stroke.

DETAILS: This study aimed to examine how TIA consultations were conducted by observing the consultations and then interviewing patients. This ethnographic study observed fifteen patient-clinician consultations where a diagnosis of TIA was made within three different TIA outpatient clinics in the East Midlands. All fifteen patients, their accompanying family-members/carers and three stroke clinicians were interviewed. Data analysis was informed by the constant comparative approach. There was considerable variation in the conduct of these consultations across sites and clinicians. This resulted in variation in patient experience and knowledge after the consultation including the ability to recognize TIA-associated risk factors and their management. As TIA symptoms resolve, patients may reduce their need to seek health care services in addition to demonstrating reduced concordance with secondary stroke prevention. Health professionals recognize that this single appointment provides patients with a large amount of information which may be difficult to process. Importantly, there was little discussion about future symptoms and how to respond. A management plan, which considered a patient’s health belief, knowledge and encouraged the involvement of family members, improved information recall.

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Copyright © 2020 Oxford University Press. All rights reserved.

Source: Family Practice. Published August 01, 2020. https://doi.org/10.1093/fampra/cmaa004


FDA Issues Recommendations Regarding Mercury-Containing Dental Amalgam

FDA issued updated recommendations concerning dental amalgam and potential risks to certain high-risk individuals that may be associated with these mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.

source: FDA

Summary

FDA Issues Recommendations for Certain High-Risk Groups Regarding Mercury-Containing Dental Amalgam

[Posted 28/Sep/2020]

AUDIENCE: Dentology, Ob/Gyn, Pediatric, Family Medicine

Part of our role in protecting patients is to regularly evaluate, monitor and update scientific evidence on the risks from medical devices—including issues related to the materials used in devices, such as metals. In the case of implanted and inserted medical devices, where materials may be in contact with the body for extended periods of time, we evaluate safety issues involved with, among other things, the body’s long-term exposure to certain materials, taking into account that sometimes uncertainties remain and more research is needed.

Today, the FDA is issuing updated recommendations concerning dental amalgam and potential risks to certain high-risk individuals that may be associated with these mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.

The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate.

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These groups that may be at a greater risk for potential harmful health effects include:

  • Pregnant women and their developing fetuses;
  • Women who are planning to become pregnant;
  • Nursing women and their newborns and infants;
  • Children, especially those younger than six years of age;
  • People with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s disease or Parkinson’s disease
  • People with impaired kidney function; and
  • People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam.

For over 20 years, the FDA has been reviewing scientific literature, monitoring reports and holding public discussions regarding the public health effects of dental amalgam and amalgam-related mercury vapor. Dental amalgam is a mixture of mercury and a powdered alloy made up of silver, tin and copper. The amalgam releases small amounts of mercury vapor over time. While low-levels of inhaled mercury vapor are generally not harmful to most people, these high-risk individuals may be at increased risk of adverse health outcomes. How much vapor is released can also depend on the age of the filling as well as a person’s habits such as teeth grinding.

These uncertainties in the most vulnerable patients are why today we are recommending people who may be at high risk for adverse health effects of mercury exposure use non-mercury alternatives to dental amalgam, such as composite resins and glass ionomer cement fillings. Dental amalgam-related mercury vapor release may be highest during placement or removal of the filling. The FDA is not recommending anyone remove or replace existing amalgam fillings in good condition unless it is considered medically necessary because removing intact amalgam fillings can cause a temporary increase in exposure to mercury vapor and the potential loss of healthy tooth structure, potentially resulting in more risks than benefits. While the available evidence suggests that dental amalgam use has generally declined over recent years, due to more alternative products being offered and used effectively for dental restorations, high-risk individuals, as noted in our recommendations, should discuss alternative products for restoring teeth with their dentist.

Our reviews and discussions have generally arrived at the same conclusion: while the majority of evidence suggests exposure to mercury vapor from dental amalgam fillings doesn’t lead to harmful health effects for most people, there may be some effects in people with certain health issues such as those who are hypersensitive to mercury. Uncertainties remain about: the effects that long-term exposure to dental amalgam may have on the specific high-risk groups we’ve listed above; the potential for mercury in dental amalgam to convert to other mercury compounds in the body; and whether the accumulation of mercury in some body fluids and tissues results in other unintended health outcomes.

We have made these recommendations after hearing from health care professionals, evaluating published literature and considering the public’s comments about dental amalgam and other metal-containing implants. During the November 2019 meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee, which discussed immunological responses to metal-containing implants and dental amalgam, we heard from several speakers, including those representing underserved communities, who expressed concern about the cumulative effect of mercury vapor exposure from dental amalgam, as well as from other (dietary and environmental) sources.

The FDA continues to believe that the benefits of materials in FDA-approved or cleared implantable and insertable medical devices outweigh their risks for most patients. However, we recognize that it is critical to closely monitor and evaluate new benefit-risk related data as biomedical science is always evolving. We continue to gather input from patients, device manufacturers, researchers and physicians to learn more about their experiences, ideas and feedback related to materials in medical devices, such as dental amalgam. We’re committed to advancing new initiatives that are rooted in sound science with a focus on patient safety remaining at the forefront.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: September 24, 2020.


FDA Alerts of Perrigo's Voluntary Albuterol Inhaler Recall

FDA is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine.

source: FDA

Summary

FDA Alerts of Perrigo's Voluntary Albuterol Inhaler Recall

[Posted 23/Sep/2020]

AUDIENCE: Pulmonology, Respiratory Care Practitioners, Family Medicine

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company in Minneapolis, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. FDA urges patients to continue using the inhaler they have on hand.

The albuterol inhaler delivers medication into the body through the airway and lungs, where it opens the airways to treat asthma and other conditions, such as chronic obstructive pulmonary disease (COPD). Patients could face health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation. FDA advises patients to:

  • immediately seek emergency care if needed;
  • use their Perrigo inhaler they have on hand, as needed and as directed by a doctor;
  • have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses; and
  • contact their health care professional or pharmacist with questions.

FDA reminds health care professionals and patients that albuterol inhalers are available through additional manufacturers.

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Perrigo informed FDA it has received several thousand complaints about its product. Most of the complaints were for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s albuterol inhaler, Catalent, stopped producing and distributing the albuterol inhaler products on August 21, 2020, and is currently investigating the malfunction.

The agency asks health care professionals and patients to report unexpected side effects or quality problems associated with albuterol inhalers to FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.
  • Source: FDA

    Published: September 21, 2020.


Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis

Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

source: Ann Fam Med

Summary

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

[Posted 24/Sep/2020]

AUDIENCE: Family Medicine, Orthopedic

KEY FINDINGS: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

BACKGROUND: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA).

DETAILS: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model. Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported.

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Source: Sit, R. W. S., Wu, R. W. K., Rabago, D., Reeves, K. D., Chan, D. C. C., Yip, B. H. K., ... Wong, S. Y. S. (2020). Efficacy of intra-articular hypertonic dextrose (Prolotherapy) for knee osteoarthritis: A randomized controlled trial. Annals of Family Medicine, 18(3), 235-242. https://doi.org/10.1370/afm.2520

Published: August 2020


Recall: M Hand Sanitizer by Medek Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

Medek is recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL (NDC 75432-001-02) because FDA analysis found the M Hand Sanitizer to contain methanol and to be subpotent for ethanol.

source: FDA Medwatch

Summary

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

[Posted 14/Sep/2020]

AUDIENCE: All Healthcare Professionals

ISSUE: Medek is recalling all lots of M Hand Sanitizer Alcohol Antiseptic 80% 128 oz/3,785 mL (NDC 75432-001-02) because FDA analysis found the M Hand Sanitizer to contain methanol and to be subpotent for ethanol.

FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination.

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The agency is aware of people ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.

Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA maintains a list of FDA-tested and recalled hand sanitizers on the agency’s website, which will be continually updated as dangerous products are discovered. FDA’s investigation of methanol in certain hand sanitizers is ongoing.

Do not use any products on this list of hand sanitizers with potential methanol contamination, and continue checking this list often as it is being updated daily. This list outlines the information on hand sanitizer labels for consumers to use to identify a product that has been tested by FDA and found to contain methanol. FDA advises consumers not to use hand sanitizers from these companies, or products with these names or NDC numbers.

The agency will provide additional information as it becomes available.

BACKGROUND: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

RECOMMENDATION: FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially:

  • After going to the bathroom
  • Before eating
  • After coughing, sneezing, or blowing one’s nose

If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Source: FDA

Published: September 10, 2020.


Inappropriate Antibiotic Allergy Documentation in Health Records

Family physicians and pharmacists perceive that few documented antibiotic allergies are in fact correct. Electronic health record barriers and communication barriers, as well as a lack of knowledge and facilitating tools, are main causes for numerous inappropriately documented antibiotic allergies and therefore targets for improving documentation in the future.

source: Ann Fam Med

Summary

Inappropriate Antibiotic Allergy Documentation in Health Records: A Qualitative Study on Family Physicians’ and Pharmacists’ Experiences

[Posted 31/Jul/2020]

AUDIENCE: Family Medicine, Pharmacist

KEY FINDINGS: Family physicians and pharmacists perceive that few documented antibiotic allergies are in fact correct. Electronic health record barriers and communication barriers, as well as a lack of knowledge and facilitating tools, are main causes for numerous inappropriately documented antibiotic allergies and therefore targets for improving documentation in the future.

BACKGROUND: It is hypothesized that 90% of antibiotic allergies documented in patients’ health records are not actual, potentially life threatening, type I allergies mediated by IgE. This distinction is important because such documentation increases antibiotic resistance, as more second-choice and broad-spectrum antibiotics are then used. Evidence is lacking regarding causes of this inappropriate documentation. To develop interventions aimed at improving documentation, we explored experiences of family physicians and pharmacists in this area.

DETAILS: We conducted a qualitative study among family physicians and pharmacists using focus group discussions, based on purposeful sampling and a naturalistic approach. Discussions were audio-recorded, transcribed verbatim, and analyzed in duplicate by means of constant comparative technique. We conducted 4 focus group discussions among 34 family physicians and 10 pharmacists, from which 3 main themes emerged: (1) magnitude and awareness of the problem of inappropriate antibiotic allergy documentation, (2) origin of the problem, and (3) approaches for addressing the problem. Participants noted that the magnitude of contamination of medical files with inappropriate documentation leads to skepticism about current documentation. Major hindering factors are electronic health record systems and electronic communication. In addition, family physicians and pharmacists believed they had insufficient knowledge about antibiotic allergies and called for tools to rectify inappropriate allergy documentation and facilitate proper documentation going forward.

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Copyright © 2020 Annals of Family Medicine, Inc. All rights reserved.

Source: The Annals of Family Medicine. Published July 2020. DOI: https://doi.org/10.1370/afm.2537


Inappropriate Antibiotic Allergy Documentation in Health Records

Family physicians and pharmacists perceive that few documented antibiotic allergies are in fact correct. Electronic health record barriers and communication barriers, as well as a lack of knowledge and facilitating tools, are main causes for numerous inappropriately documented antibiotic allergies and therefore targets for improving documentation in the future.

source: Ann Fam Med

Summary

Inappropriate Antibiotic Allergy Documentation in Health Records: A Qualitative Study on Family Physicians’ and Pharmacists’ Experiences

[Posted 31/Jul/2020]

AUDIENCE: Family Medicine, Pharmacist

KEY FINDINGS: Family physicians and pharmacists perceive that few documented antibiotic allergies are in fact correct. Electronic health record barriers and communication barriers, as well as a lack of knowledge and facilitating tools, are main causes for numerous inappropriately documented antibiotic allergies and therefore targets for improving documentation in the future.

BACKGROUND: It is hypothesized that 90% of antibiotic allergies documented in patients’ health records are not actual, potentially life threatening, type I allergies mediated by IgE. This distinction is important because such documentation increases antibiotic resistance, as more second-choice and broad-spectrum antibiotics are then used. Evidence is lacking regarding causes of this inappropriate documentation. To develop interventions aimed at improving documentation, we explored experiences of family physicians and pharmacists in this area.

DETAILS: We conducted a qualitative study among family physicians and pharmacists using focus group discussions, based on purposeful sampling and a naturalistic approach. Discussions were audio-recorded, transcribed verbatim, and analyzed in duplicate by means of constant comparative technique. We conducted 4 focus group discussions among 34 family physicians and 10 pharmacists, from which 3 main themes emerged: (1) magnitude and awareness of the problem of inappropriate antibiotic allergy documentation, (2) origin of the problem, and (3) approaches for addressing the problem. Participants noted that the magnitude of contamination of medical files with inappropriate documentation leads to skepticism about current documentation. Major hindering factors are electronic health record systems and electronic communication. In addition, family physicians and pharmacists believed they had insufficient knowledge about antibiotic allergies and called for tools to rectify inappropriate allergy documentation and facilitate proper documentation going forward.

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Copyright © 2020 Annals of Family Medicine, Inc. All rights reserved.

Source: The Annals of Family Medicine. Published July 2020. DOI: https://doi.org/10.1370/afm.2537


Prevalence of IPV and Beliefs About Partner Violence Screening Among Young Men

Among young US men, 9 in 10 support IPV identification by health care clinicians, nearly 1 in 5 report using IPV, but only about 1 in 10 report health care clinicians asking about IPV.

source: Ann Fam Med

Summary

Prevalence of Intimate Partner Violence and Beliefs About Partner Violence Screening Among Young Men

[Posted 16/Jul/2020]

AUDIENCE: Family Medicine

KEY FINDINGS: Among young US men, 9 in 10 support IPV identification by health care clinicians, nearly 1 in 5 report using IPV, but only about 1 in 10 report health care clinicians asking about IPV. These represent missed opportunities for health care IPV identification. Beliefs and experiences regarding health care IPV identification vary by race, education, and men’s IPV perpetration and victimization. These disparities can inform tailored health care identification approaches.

BACKGROUND: Few clinical guidelines focus on how physicians can identify intimate partner violence (IPV) perpetration or victimization among male patients, and little is known of men’s experiences and beliefs regarding screening in health care settings. Our objective was to determine prevalence of men’s experiences with IPV screening in health care settings and associations with men’s beliefs regarding health care clinician identification of IPV.

DETAILS: Using a cross-sectional online survey of a nationally representative sample of 916 men aged 18-35 years, we conducted survey-weighted descriptive analyses to determine IPV prevalence, screening experiences and beliefs, and multivariate logistic regression to examine associations of demographics, IPV perpetration, and IPV victimization with men’s screening experiences and beliefs. Of 916 men surveyed, 19% reported perpetration and 27% reported victimization in relationship with current or previous spouse/partner, 90% believed health care clinicians should ask about perpetration, 92% believed health care clinicians should ask about victimization, but only 11% had been asked about perpetration and 13% about victimization. Beliefs regarding IPV were associated with African American non-Hispanic race, IPV perpetration, and IPV victimization. Experiences being asked about IPV were associated with educational attainment and IPV perpetration.

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Copyright © 2020 Annals of Family Medicine, Inc. All rights reserved.

Source: Ann Fam Med. Published July 2020. DOI: https://doi.org/10.1370/afm.2536


Hospitalizations and Deaths Associated with EVALI

Chronic conditions, including cardiac and respiratory diseases and mental health conditions, were common among hospitalized patients with EVALI.

source: NEJM

Summary

Hospitalizations and Deaths Associated with EVALI

[Posted 05/Jun/2020]

AUDIENCE: Family Medicine

KEY FINDINGS: Chronic conditions, including cardiac and respiratory diseases and mental health conditions, were common among hospitalized patients with EVALI.

BACKGROUND: As of January 7, 2020, a total of 2558 hospitalized patients with nonfatal cases and 60 patients with fatal cases of e-cigarette, or vaping, product use-associated lung injury (EVALI) had been reported to the Centres for Disease Control and Prevention (CDC).

DETAILS: In a national study, the characteristics of patients with fatal cases of EVALI with those of patients with nonfatal cases were compared to improve the ability of clinicians to identify patients at increased risk for death from the condition. Health departments reported cases of EVALI to the CDC and included, when available, data from medical-record abstractions and patient interviews. Analyses included all the patients with fatal or nonfatal cases of EVALI that were reported to the CDC as of January 7, 2020. Three case reports of patients who died from EVALI were presented to illustrate the clinical characteristics common among such patients.Most of the patients with fatal or nonfatal cases of EVALI were male (32 of 60 [53%] and 1666 of 2498 [67%], respectively). The proportion of patients with fatal or nonfatal cases was higher among those who were non-Hispanic white (39 of 49 [80%] and 1104 of 1818 [61%], respectively) than among those in other race or ethnic groups. The proportion of patients with fatal cases was higher among those 35 years of age or older (44 of 60 [73%]) than among those younger than 35 years, but the proportion with nonfatal cases was lower among those 35 years of age or older (551 of 2514 [22%]). Among the patients who had an available medical history, a higher proportion of those with fatal cases than those with nonfatal cases had a history of asthma (13 of 57 [23%] vs. 102 of 1297 [8%]), cardiac disease (26 of 55 [47%] vs. 115 of 1169 [10%]), or a mental health condition (32 of 49 [65%] vs. 575 of 1398 [41%]). A total of 26 of 50 patients (52%) with fatal cases had obesity. Half the patients with fatal cases (25 of 54 [46%]) were seen in an outpatient setting before hospitalization or death.

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Source: Werner, A. K. et al. (2020) ‘Hospitalizations and Deaths Associated with EVALI’, New England Journal of Medicine. Massachusetts Medical Society, 382(17), pp. 1589–1598. doi: 10.1056/NEJMoa1915314.

Published: April 2020


Neurological Outcomes of Congenital Zika Syndrome in Toddlers and Preschoolers

For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication

source: The Lancet

Summary

Neurological Outcomes of Congenital Zika Syndrome in Toddlers and Preschoolers: a Case Series

[Posted 27/Apr/2020]

AUDIENCE: Family Medicine

KEY FINDINGS: We describe distinct neurological profiles in the congenital Zika syndrome spectrum, with functional outcomes tending to correlate with these groups. The clinical division of children based on the disease signs proposed here is supported by the literature on central and peripheral nervous system pathology in congenital Zika syndrome. The high prevalence of dyskinetic symptoms merits special attention.

BACKGROUND: Congenital Zika syndrome causes a spectrum of neurological symptoms with varying effects on function that require different therapeutic strategies. To date, this spectrum of effects and its clinical implications have not been completely described. We describe the neurological examination findings in toddlers and preschoolers, including predominant symptom complexes and comorbidities.

DETAILS: This study is a case-series neurological evaluation of 75 children with congenital Zika syndrome in Campina Grande, Brazil. The study is part of a cohort of children with congenital Zika syndrome that started in 2015 and is still ongoing. Children with Zika virus infection detected during pregnancy (mothers exhibited rash and were followed and diagnosed by fetal ultrasound abnormalities or RT-PCR) or through microcephaly screening after birth, using Intergrowth 21 guidelines, were selected by laboratory and radiological criteria. Children were examined during a 10-day period in September, 2018, and underwent neurological interview, examination, and assessment of functional outcomes and comorbidities. Children were divided in groups of predominant corticospinal or neuromuscular clinical signs and the associations between these groups and clinical comorbidities were assessed. All of the children recruited to the study from Nov 29, 2015 to Nov 30, 2017 had imaging correlates of congenital Zika syndrome. Children were assigned to groups depending on the signs exhibited, either corticospinal or neuromuscular, with or without dyskinetic signs. 75 children completed the evaluation, 38 (51%) girls and 37 (49%) boys. Median age was 33 months (range 26–40 months; IQR 29–34). Microcephaly was present at birth in 56 (75%) children, and 19 (25%) children were born with normal head circumference, 15 of whom later developed microcephaly. Neurological examination grouped four children as having isolated dyskinetic signs, 48 children were assigned to the corticospinal group and 23 into the neuromuscular group. Dyskinetic findings were present in 30 (40%) children, either alone (four [5%]) or combined with corticospinal (19 [40%] of 48) or neuromuscular (seven [30%] of 23) findings. Comorbidities were highly prevalent, and the neuromuscular group had worse functional outcomes, evaluated by gross motor function (p=0.026), manual abilities (p=0.0013), and communication function (p<0.0005) classification scales, than the corticospinal group, whereas pneumonia (p<0.0005) and urinary tract infections (p<0.0005) were more frequent in the corticospinal group. Cortical hyperexcitability was supported by several clinical correlates, such as early onset epilepsy, persistence of primitive reflexes, and dystonia.

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FUNDING: Brazilian National Council for Scientific and Technological Development and by the Coordination for the Improvement of Higher Education Personnel.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Source: The Lancet. Published March 18, 2020. DOI:https://doi.org/10.1016/S2352-4642(20)30041-9


The Effect of Warfarin Administration Time on Anticoagulation Stability (INRange)

Administration time has no statistically significant nor clinically important impact on the stability of warfarin's anticoagulant effect.

source: Ann Fam Med

Summary

The Effect of Warfarin Administration Time on Anticoagulation Stability (INRange): A Pragmatic Randomized Controlled Trial

[Posted 12/Mar/2020]

AUDIENCE: Family Medicine, Cardiology, Internal Medicine

KEY FINDINGS: Administration time has no statistically significant nor clinically important impact on the stability of warfarin’s anticoagulant effect. Patients should take warfarin whenever regular compliance would be easiest.

BACKGROUND: Without supporting evidence, clinicians commonly recommend that warfarin be taken in the evening. We conducted a randomized controlled trial to evaluate the effect of administration time (morning vs evening) on the stability of warfarin’s anticoagulant effect.

DETAILS: A total of 236 primary care physicians serving 54 western Canadian communities mailed letters of invitation to all their warfarin-using patients. Eligible patients were community-dwelling warfarin users (any indication) with at least 3 months of evening warfarin use and no plans for discontinuation. Participants were randomized (by web-based allocation) to morning vs continued evening warfarin ingestion. We used the Rosendaal method to determine the proportion of time within therapeutic range (TTR) of the international normalized ratio (INR) blood test month 2 to 7 postrandomization vs the 6 months prerandomization. The primary outcome was the percent change in proportion of time outside target INR range (with an a priori minimum clinically important difference of ±20%). All analyses were intention to treat. Between March 8, 2015 and September 30, 2016, we randomized 109 participants to morning and 108 to evening warfarin use. TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, –0.1%; P = .97; 95% CI for the difference, –6.1% to 5.9%). The difference in percent change in proportion of time outside the therapeutic INR range (obtained via Hodges-Lehmann estimation of the difference in medians) was 4.4% (P = .62; 95% CI for the difference, –17.6% to 27.3%).

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Copyright © 2020 Annals of Family Medicine, Inc. All rights reserved.

Source: Ann Fam Med. Published February 2020. doi: 10.1370/afm.2488


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