Novedades Bibliográficas

Database Updates and Resulting Changes in Data in Study of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy

JAMA - Mar, 16/02/2021 - 02:00
To the Editor My coauthors and I report some database updates and resulting changes in our Original Investigation titled “Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial,” published in the September 17, 2019, issue of JAMA. During the final database cleaning for the final 5-year study database lock, a biannual study-wide audit review of the Pelvic Organ Prolapse Quantification (POPQ) examination data identified some updates that influenced the value of the primary outcome (treatment failure). There were 3 failure events for which a POPQ data correction either increased the time to initial failure (1 patient randomized to undergo hysteropexy) or changed the value of the event from a failure to a nonfailure (1 patient randomized to undergo hysteropexy and 1 randomized to undergo hysterectomy). In addition, there were a few minor database updates that did not affect the primary outcome but altered some of the at-visit failure and failure-type rates. The adjusted hazard ratio of failure for hysteropexy vs hysterectomy changed from 0.62 to 0.61.

Geographic Differences in Uncontrolled Chronic Medical Conditions

JAMA - Mar, 16/02/2021 - 02:00
To the Editor Using Veterans Health Administration records, Dr Baum and colleagues estimated the differences in the prevalence of uncontrolled chronic conditions across the population of veterans who moved and the likelihood of uncontrolled chronic conditions after moving. They also provided an E-value estimating the strength of association that an unknown confounder must explain the observed association. However, this article did not provide a measure of the original strength of the association. It would have been illustrative if the authors had provided an original odds ratio or relative risk of disease for comparison purposes.

The Advantages of Medicare Advantage

JAMA - Mar, 16/02/2021 - 02:00
To the Editor In a recent JAMA Forum, Dr Butler considered the political appeal of Medicare Advantage expansion, including growing enrollment, promotion of managed care, and lower federal spending. However, this appeal misses the purpose of health care reform, succinctly summarized by William Kissick, MD, as the simultaneous achievement of increased access, decreased costs, and improved outcomes. A simpler description is better care to more people for less money.

Wound Dressings for Obese Women After Cesarean Delivery

JAMA - Mar, 16/02/2021 - 02:00
To the Editor In their recent article, Dr Tuuli and colleagues found no difference in the rates of superficial or deep surgical site infection between obese women randomized to prophylactic negative pressure wound therapy vs standard wound dressing after cesarean delivery. We have some concerns, however, about how the standard wound dressings were managed in this study. Negative pressure dressings are designed to be kept intact for a relatively long period on closed incisions, while typical surgical dressings are changed more frequently. In this study, the dressings in the control group were removed after 24 hours. However, the authors did not provide any data about whether these wounds were redressed, frequency of dressing changes, or whether there was any change in the type of dressing after the initial postoperative dressing was removed. Variations in these factors are potential confounders that make it difficult to draw conclusions about the comparative efficacy of negative pressure wound therapy in obese women after cesarean delivery.

Current Comment

JAMA - Mar, 16/02/2021 - 02:00

Diagnosis and Treatment of Anal Fissures in 2021

JAMA - Mar, 16/02/2021 - 02:00
This JAMA Insights Clinical Update reviews the diagnosis and management of anal fissures, including use of supportive, topical, injection, and surgical treatment options.

Audio Highlights

JAMA - Mar, 16/02/2021 - 02:00
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.

Immortal Time Bias in Observational Studies

JAMA - Mar, 16/02/2021 - 02:00
This JAMA Guide to Statistics and Medicine explains immortal time bias, an error in estimating the association between an exposure and an outcome that results from misclassification or exclusion of time intervals; explains how this misclassification or exclusion can occur; and presents approaches to minimize or avoid immortal time bias.

More Scrutiny for Laparoscopic Power Morcellator Procedures

JAMA - Mar, 16/02/2021 - 02:00
In an updated safety communication, the FDA recommended that clinicians who perform laparoscopic power morcellation for gynecologic procedures should do so with a legally marketed containment system to prevent unsuspected cancer from spreading within the abdomen and pelvis.

Advice for n-of-1 Drug Developers

JAMA - Mar, 16/02/2021 - 02:00
The FDA has issued draft recommendations to help developers of antisense oligonucleotide (ASO) therapies for rare, debilitating genetic diseases to conduct human trials with a single participant, known as n-of-1 trials.

Generic Glucagon Approved for Severe Hypoglycemia

JAMA - Mar, 16/02/2021 - 02:00
The first generic version of injectable glucagon for treating severe hypoglycemia has received FDA approval. Packaged as an emergency kit with a 1-mg dose, the drug treats extremely low blood glucose in patients with diabetes. The drug is also indicated to slow bowel motion during radiological examinations to provide a clear picture of abdominal and pelvic areas.

Maternal Cardiovascular Health

JAMA - Mar, 16/02/2021 - 02:00
Historically, the focus on the development of atherosclerotic cardiovascular disease has been on individual risk factors. These factors, which are associated with increased risk of myocardial infarction and stroke, were identified in the Framingham Study and other longitudinal observational studies of adults. The traditional risk factors are hypertension, dyslipidemia, obesity, diabetes, and cigarette smoking. Subsequently, other potential risk factors, such as inflammation and insulin resistance, have been included in the discussion. The recognition of risk factors was a substantial advance because it provided clinical targets for intervention. Subsequent research has demonstrated that interventions that result in improvement in risk factors do reduce the risk of morbidity and mortality from cardiovascular disease. Research has shown that these risk factors are present in children and adolescents and are associated with increased prevalence and severity of atherosclerotic lesions in individuals who had autopsies after death due to various causes and trauma.

Error in Results Section

JAMA - Mar, 16/02/2021 - 02:00
The Original Investigation titled “Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial,” published in the September 17, 2019, issue of JAMA, included errors in the data in the Results section. The data have been corrected in the Results section, including in the tables and figures. (All other information in the Results section was correct and is unchanged.)

Hospital Clowns Ease Children’s Symptoms, Review Shows

JAMA - Mar, 16/02/2021 - 02:00
This Medical News article describes a review of studies that examine whether hospital clowns can help alleviate pediatric patients’ symptoms such stress, anxiety, and pain.

Recalibrating the Use of Race in Medical Research

JAMA - Mar, 16/02/2021 - 02:00
This Viewpoint reviews the way race has been used and misused in medical research and urges careful consideration by investigators of how its use might ameliorate or worsen health inequalities.

Accounting for Systemic Racism In USPSTF Recommendation Statements

JAMA - Mar, 16/02/2021 - 02:00
This Viewpoint discusses ways the US Preventive Services Task Force (USPSTF) is working to identify contributions of systemic racism to differences in health outcomes, and to develop evidence-based recommendations to mitigate the effects of social, economic, and structural disadvantage on disease and its related sequelae.

Race and Pharmacogenomics—Personalized Medicine or Misguided Practice?

JAMA - Mar, 16/02/2021 - 02:00
This Viewpoint uses examples of recommendations for race-based pharmacogenetic testing to discuss flaws and inconsistencies with race and ethnicity as surrogates for biology, and the consequences of those deficiencies for clinical decision-making.

Effect of Bamlanivimab Alone vs With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19

JAMA - Mar, 16/02/2021 - 02:00
This randomized clinical trial compares the effects of 3 doses of bamlanivimab monotherapy (700 vs 2800 vs 7000 mg) vs combination bamlanivimab and etesevimab vs placebo on change in day 11 severe acute respiratory syndrome coronavirus 2 viral load in patients with mild to moderate coronavirus disease 2019 (COVID-19).

Neutralizing Monoclonal Antibody for Mild to Moderate COVID-19

JAMA - Mar, 16/02/2021 - 02:00
In this issue of JAMA, Gottlieb et al report the findings of the ongoing BLAZE-1 (Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies) trial, a randomized, phase 2/3 clinical trial of antispike neutralizing monoclonal antibody treatment among 577 outpatients with mild or moderate coronavirus disease 2019 (COVID-19). This report represents the final analysis of the phase 2 portion of this trial and included 5 cohorts (3 groups with varying doses of bamlanivimab monotherapy, 1 group with a combination therapy of bamlanivimab and etesevimab, and a placebo group). The findings for the difference between each of the 3 monotherapy groups compared with the placebo group for the primary end point of change in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) log viral load at day 11 from baseline were not statistically significant, but were statistically significantly different for the primary end point for the combination therapy group compared with the placebo group.

Changes in Abortion in Texas Following an Executive Order Ban During the Coronavirus Pandemic

JAMA - Mar, 16/02/2021 - 02:00
This study assesses changes in abortions performed and at what gestational age following a Texas order postponing non–medically necessary surgeries due to the COVID-19 pandemic compared with abortions performed during the same months in 2019.
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