Publications by authors named "Karina W Davidson"

300 Publications

Anhedonic Depression Is Not Associated With Risk of Recurrent Major Adverse Cardiac Events and All-Cause Mortality in Acute Coronary Syndrome Patients.

Ann Behav Med 2021 Oct 12. Epub 2021 Oct 12.

Center for Personalized Health, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.

Background: Depression after acute coronary syndrome (ACS) is common and increases risks of adverse outcomes, but it remains unclear which depression features are most associated with major adverse cardiac events (MACE) and all-cause mortality (ACM).

Purpose: To examine whether a subtype of depression characterized by anhedonia and major depressive disorder (MDD) predicts 1-year MACE/ACM occurrence in ACS patients compared to no MDD history. We also consider other depression features in the literature as predictors.

Methods: Patients (N = 1,087) presenting to a hospital with ACS completed a self-report measure of current depressive symptoms in-hospital and a diagnostic interview assessing MDD within 1 week post-hospitalization. MACE/ACM events were assessed at 1-, 6-, and 12-month follow-ups. Cox regression models were used to examine the association of the anhedonic depression subtype and MDD without anhedonia with time to MACE/ACM, adjusting for sociodemographic and clinical covariates.

Results: There were 142 MACE/ACM events over the 12-month follow-up. The 1-year MACE/ACM in patients with anhedonic depression, compared to those with no MDD, was somewhat higher in an age-adjusted model (hazard ratio [HR] = 1.63, p = .08), but was not significant after further covariate adjustment (HR = 1.24, p = .47). Of the additional depression features, moderate-to-severe self-reported depressive symptoms significantly predicted the risk of MACE/ACM, even in covariate-adjusted models (HR = 1.72, p = .04), but the continuous measure of self-reported depressive symptoms did not.

Conclusion: The anhedonic depression subtype did not uniquely predict MACE/ACM as hypothesized. Moderate-to-severe levels of total self-reported depressive symptoms, however, may be associated with increased MACE/ACM risk, even after accounting for potential sociodemographic and clinical confounders.
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http://dx.doi.org/10.1093/abm/kaab092DOI Listing
October 2021

Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 09;326(12):1186-1191

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Preeclampsia is one of the most serious health problems that affect pregnant persons. It is a complication in approximately 4% of pregnancies in the US and contributes to both maternal and infant morbidity and mortality. Preeclampsia also accounts for 6% of preterm births and 19% of medically indicated preterm births in the US. There are racial and ethnic disparities in the prevalence of and mortality from preeclampsia. Non-Hispanic Black women are at greater risk for developing preeclampsia than other women and experience higher rates of maternal and infant morbidity and perinatal mortality.

Objective: To update its 2014 recommendation, the USPSTF commissioned a systematic review to evaluate the effectiveness of low-dose aspirin use to prevent preeclampsia.

Population: Pregnant persons at high risk for preeclampsia who have no prior adverse effects with or contraindications to low-dose aspirin.

Evidence Assessment: The USPSTF concludes with moderate certainty that there is a substantial net benefit of daily low-dose aspirin use to reduce the risk for preeclampsia, preterm birth, small for gestational age/intrauterine growth restriction, and perinatal mortality in pregnant persons at high risk for preeclampsia.

Recommendation: The USPSTF recommends the use of low-dose aspirin (81 mg/d) as preventive medication for preeclampsia after 12 weeks of gestation in persons who are at high risk for preeclampsia. (B recommendation).
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http://dx.doi.org/10.1001/jama.2021.14781DOI Listing
September 2021

Screening for Chlamydia and Gonorrhea: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 09;326(10):949-956

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Chlamydia and gonorrhea are among the most common sexually transmitted infections in the US. Infection rates are highest among adolescents and young adults of both sexes. Chlamydial and gonococcal infections in women are usually asymptomatic and may lead to pelvic inflammatory disease and its associated complications. Newborns of pregnant persons with untreated infection may develop neonatal chlamydial pneumonia or gonococcal or chlamydial ophthalmia. Infection in men may lead to urethritis and epididymitis. Both types of infection can increase risk of acquiring or transmitting HIV.

Objective: To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for chlamydia and gonorrhea in sexually active adolescents and adults, including pregnant persons.

Population: Asymptomatic, sexually active adolescents and adults, including pregnant persons.

Evidence Assessment: The USPSTF concludes with moderate certainty that screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes with moderate certainty that screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection has moderate net benefit. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.

Recommendation: The USPSTF recommends screening for chlamydia in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF recommends screening for gonorrhea in all sexually active women 24 years or younger and in women 25 years or older who are at increased risk for infection. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men. (I statement).
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http://dx.doi.org/10.1001/jama.2021.14081DOI Listing
September 2021

Incorporation of Social Risk in US Preventive Services Task Force Recommendations and Identification of Key Challenges for Primary Care.

JAMA 2021 Oct;326(14):1410-1415

Agency for Healthcare Research and Quality, Rockville, Maryland.

Importance: In its mission to improve health, the US Preventive Services Task Force (USPSTF) recognizes the strong relationship between a person's health and social and economic circumstances as well as persistent inequities in health care delivery.

Objective: To assess how social risks have been considered in USPSTF recommendation statements and identify current gaps in evidence needed to expand the systematic inclusion of social risks in future recommendations.

Evidence: The USPSTF commissioned a technical brief that reviewed existing literature on screening and interventions for social risk factors and also audited the 85 USPSTF recommendation statements active as of December 2019 to determine how social risks were addressed in clinical preventive services recommendations.

Findings: Among the 85 USPSTF recommendation statements reviewed, 14 were focused on preventive services that considered health-related social risks. Social risks were commonly referenced in parts of USPSTF recommendations, with 57 of 85 recommendations including some comment on social risks within the recommendation statement, although many comments were not separate prevention services. Social risks were commented on in USPSTF recommendations as part of risk assessment, as a marker of worse health outcomes from the condition of focus, as a consideration for clinicians when implementing the preventive service, and as a research need or gap on the topic.

Conclusions And Relevance: This report identified how social risks have been considered in the USPSTF recommendation statements. It serves as a benchmark and foundation for ongoing work to advance the goal of ensuring that health equity and social risks are incorporated in USPSTF methods and recommendations.
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http://dx.doi.org/10.1001/jama.2021.12833DOI Listing
October 2021

Screening for Prediabetes and Type 2 Diabetes: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 08;326(8):736-743

Tufts University School of Medicine, Boston, Massachusetts.

Importance: An estimated 13% of all US adults (18 years or older) have diabetes, and 34.5% meet criteria for prediabetes. The prevalences of prediabetes and diabetes are higher in older adults. Estimates of the risk of progression from prediabetes to diabetes vary widely, perhaps because of differences in the definition of prediabetes or the heterogeneity of prediabetes. Diabetes is the leading cause of kidney failure and new cases of blindness among adults in the US. It is also associated with increased risks of cardiovascular disease, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis and was estimated to be the seventh leading cause of death in the US in 2017. Screening asymptomatic adults for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment, with the ultimate goal of improving health outcomes.

Objective: To update its 2015 recommendation, the USPSTF commissioned a systematic review to evaluate screening for prediabetes and type 2 diabetes in asymptomatic, nonpregnant adults and preventive interventions for those with prediabetes.

Population: Nonpregnant adults aged 35 to 70 years seen in primary care settings who have overweight or obesity (defined as a body mass index ≥25 and ≥30, respectively) and no symptoms of diabetes.

Evidence Assessment: The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit.

Conclusions And Recommendation: The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions. (B recommendation).
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http://dx.doi.org/10.1001/jama.2021.12531DOI Listing
August 2021

Screening for Gestational Diabetes: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 08;326(6):531-538

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Gestational diabetes is diabetes that develops during pregnancy. Prevalence of gestational diabetes in the US has been estimated at 5.8% to 9.2%, based on traditional diagnostic criteria, although it may be higher if more inclusive criteria are used. Pregnant persons with gestational diabetes are at increased risk for maternal and fetal complications, including preeclampsia, fetal macrosomia (which can cause shoulder dystocia and birth injury), and neonatal hypoglycemia. Gestational diabetes has also been associated with an increased risk of several long-term health outcomes in pregnant persons and intermediate outcomes in their offspring.

Objective: The USPSTF commissioned a systematic review to evaluate the accuracy, benefits, and harms of screening for gestational diabetes and the benefits and harms of treatment for the pregnant person and infant.

Population: Pregnant persons who have not been previously diagnosed with type 1 or type 2 diabetes.

Evidence Assessment: The USPSTF concludes with moderate certainty that there is a moderate net benefit to screening for gestational diabetes at 24 weeks of gestation or after to improve maternal and fetal outcomes. The USPSTF concludes that the evidence on screening for gestational diabetes before 24 weeks of gestation is insufficient, and the balance of benefits and harms of screening cannot be determined.

Recommendation: The USPSTF recommends screening for gestational diabetes in asymptomatic pregnant persons at 24 weeks of gestation or after. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for gestational diabetes in asymptomatic pregnant persons before 24 weeks of gestation. (I statement).
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http://dx.doi.org/10.1001/jama.2021.11922DOI Listing
August 2021

Single case designs for early phase behavioral translational research in health psychology.

Health Psychol 2021 Aug 9. Epub 2021 Aug 9.

Center for Personalized Health.

Objective: The biomedical research community has long recognized that much of the basic research being conducted, whether in the biological, behavioral or social sciences, is not readily translated into clinical and public health applications. This translational gap is due in part to challenges inherent in moving research findings from basic or discovery research to applied research that addresses clinical or public health problems. In the behavioral and social sciences, research designs typically used in the early phases of translational research are small, underpowered "pilot" studies that may lack sufficient statistical power to test the research question of interest. While this approach is discouraged, these studies are often employed to estimate effect sizes before embarking on a larger trial with adequate statistical power to test the research hypothesis. The goal of this paper is to provide an alternative approach to early phase studies using single case designs (SCDs).

Method: Review basic principles of SCDs; provide a series of hypothetical SCD replication experiments to illustrate (1) how data from SCDs can be analyzed to test the effects of an intervention on behavioral and biological outcomes and (2) how sample sizes can be derived for larger randomized controlled trials (RCTs) based on clinically meaningful effects from SCDs; and review feedback between SCDs and RCTs.

Results: The paper illustrates the use of SCD reversal and multiple baseline designs for early phase translational research.

Conclusion: SCDs provide a flexible and efficient platform for the use of experimental methods in early phase translational research. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/hea0001055DOI Listing
August 2021

A National Call to Action for a Feasible Equitable Approach to Childhood Obesity.

Pediatrics 2021 Jul 29;148(1). Epub 2021 Jun 29.

Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.

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http://dx.doi.org/10.1542/peds.2021-051052DOI Listing
July 2021

Racial and ethnic minority patient participation in N-of-1 trials: perspectives of healthcare providers and patients.

Per Med 2021 07 28;18(4):347-359. Epub 2021 May 28.

Institute for Health System Science, Center for Personalized Health, Feinstein Institutes for Medical Research, Manhasset, NY 11030, USA.

Patients from racial and ethnic minority backgrounds in the USA have historically been under-represented in research trials. Understanding their viewpoints regarding participation in N-of-1 trials is imperative as we design and implement these studies. We conducted six focus groups of racial and ethnic minority patients (n = 25) and providers (n = 9). We used content analysis to identify themes. Our results noted the importance of considering family members in N-of-1 trial recruitment and participation, patients' desire for education as a design feature, for 'lifestyle' changes as a treatment option and for use of nonevidence-based treatments in the design of future N-of-1 trials. Personalized trials have the potential to change the way we deliver primary care and improve disparities for minorities.
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http://dx.doi.org/10.2217/pme-2020-0166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242982PMC
July 2021

Behavioral Counseling Interventions for Healthy Weight and Weight Gain in Pregnancy: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 05;325(20):2087-2093

Tufts University School of Medicine, Boston, Massachusetts.

Importance: The prevalence of overweight and obesity is increasing among persons of childbearing age and pregnant persons. In 2015, almost half of all persons began pregnancy with overweight (24%) or obesity (24%). Reported rates of overweight and obesity are higher among Black, Alaska Native/American Indian, and Hispanic women and lower among White and Asian women. Excess weight at the beginning of pregnancy and excess gestational weight gain have been associated with adverse maternal and infant health outcomes such as a large for gestational age infant, cesarean delivery, or preterm birth.

Objective: The USPSTF commissioned a systematic review to evaluate the benefits and harms of behavioral counseling interventions to prevent adverse health outcomes associated with obesity during pregnancy and to evaluate intermediate outcomes, including excess gestational weight gain. This is a new recommendation.

Population: Pregnant adolescents and adults in primary care settings.

Evidence Assessment: The USPSTF concludes with moderate certainty that behavioral counseling interventions aimed at promoting healthy weight gain and preventing excess gestational weight gain in pregnancy have a moderate net benefit for pregnant persons.

Recommendation: The USPSTF recommends that clinicians offer pregnant persons effective behavioral counseling interventions aimed at promoting healthy weight gain and preventing excess gestational weight gain in pregnancy. (B recommendation).
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http://dx.doi.org/10.1001/jama.2021.6949DOI Listing
May 2021

Introducing the MAVEN Leadership Training Initiative to diversify the scientific workforce.

Elife 2021 05 25;10. Epub 2021 May 25.

Feinstein Institutes for Medical Research, Northwell Health, Manhasset, United States.

Addressing gender and racial-ethnic disparities at all career stages is a priority for the research community. In this article, we focus on efforts to encourage mid-career women, particularly women of color, to move into leadership positions in science and science policy. We highlight the need to strengthen leadership skills for the critical period immediately following promotion to associate/tenured professor - when formal career development efforts taper off while institutional demands escalate - and describe a program called MAVEN that has been designed to teach leadership skills to mid-career women scientists, particularly those from underrepresented groups.
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http://dx.doi.org/10.7554/eLife.69063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8149121PMC
May 2021

Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 05;325(19):1965-1977

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52 980 persons in the US projected to die of colorectal cancer in 2021. Colorectal cancer is most frequently diagnosed among persons aged 65 to 74 years. It is estimated that 10.5% of new colorectal cancer cases occur in persons younger than 50 years. Incidence of colorectal cancer (specifically adenocarcinoma) in adults aged 40 to 49 years has increased by almost 15% from 2000-2002 to 2014-2016. In 2016, 26% of eligible adults in the US had never been screened for colorectal cancer and in 2018, 31% were not up to date with screening.

Objective: To update its 2016 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for colorectal cancer in adults 40 years or older. The review also examined whether these findings varied by age, sex, or race/ethnicity. In addition, as in 2016, the USPSTF commissioned a report from the Cancer Intervention and Surveillance Modeling Network Colorectal Cancer Working Group to provide information from comparative modeling on how estimated life-years gained, colorectal cancer cases averted, and colorectal cancer deaths averted vary by different starting and stopping ages for various screening strategies.

Population: Asymptomatic adults 45 years or older at average risk of colorectal cancer (ie, no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease; no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer [such as Lynch syndrome or familial adenomatous polyposis]).

Evidence Assessment: The USPSTF concludes with high certainty that screening for colorectal cancer in adults aged 50 to 75 years has substantial net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 45 to 49 years has moderate net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 76 to 85 years who have been previously screened has small net benefit. Adults who have never been screened for colorectal cancer are more likely to benefit.

Recommendation: The USPSTF recommends screening for colorectal cancer in all adults aged 50 to 75 years. (A recommendation) The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years. Evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient's overall health, prior screening history, and preferences. (C recommendation).
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http://dx.doi.org/10.1001/jama.2021.6238DOI Listing
May 2021

Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial.

Gen Hosp Psychiatry 2021 Jul-Aug;71:47-54. Epub 2021 Apr 3.

Columbia University Irving Medical Center, New York, NY, United States of America.

Objective: To evaluate the cost-effectiveness of screening for depression in patients with acute coronary syndrome (ACS) and no history of depression.

Methods: Cost-effectiveness analysis of a randomized trial enrolling 1500 patients with ACS between 2013 and 2017. Patients were randomized to no screening, screening and notifying the primary care provider (PCP), and screening, notifying the PCP, and providing enhanced depression treatment. Outcomes measured were Healthcare utilization, costs, and incremental cost-effectiveness ratios.

Results: 7.1% of patients screened positive for depressive symptoms. There was no significant difference in usage of mental health services, cardiovascular tests and procedures, and medications. Mean total costs in No Screen group ($7440), in Screen, Notify, and Treat group ($6745), and in Screen and Notify group ($6204). The difference was only significant in the Screen and Notify group versus the No Screen group (-$1236, 95% confidence interval -$2388 to -$96). Because mean QALYs were higher (+0.003 QALY in Screen and Notify; +0.004 QALYs in Screen, Notify, and Treat) and mean total costs were lower in both intervention groups, these interventions were cost-effective. There was substantial uncertainty because confidence intervals around cost differences were wide and QALY effects were small.

Conclusion: Depression screening strategies for patients with ACS may be modestly cost-effective.
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http://dx.doi.org/10.1016/j.genhosppsych.2021.04.001DOI Listing
April 2021

Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial.

Gen Hosp Psychiatry 2021 Jul-Aug;71:47-54. Epub 2021 Apr 3.

Columbia University Irving Medical Center, New York, NY, United States of America.

Objective: To evaluate the cost-effectiveness of screening for depression in patients with acute coronary syndrome (ACS) and no history of depression.

Methods: Cost-effectiveness analysis of a randomized trial enrolling 1500 patients with ACS between 2013 and 2017. Patients were randomized to no screening, screening and notifying the primary care provider (PCP), and screening, notifying the PCP, and providing enhanced depression treatment. Outcomes measured were Healthcare utilization, costs, and incremental cost-effectiveness ratios.

Results: 7.1% of patients screened positive for depressive symptoms. There was no significant difference in usage of mental health services, cardiovascular tests and procedures, and medications. Mean total costs in No Screen group ($7440), in Screen, Notify, and Treat group ($6745), and in Screen and Notify group ($6204). The difference was only significant in the Screen and Notify group versus the No Screen group (-$1236, 95% confidence interval -$2388 to -$96). Because mean QALYs were higher (+0.003 QALY in Screen and Notify; +0.004 QALYs in Screen, Notify, and Treat) and mean total costs were lower in both intervention groups, these interventions were cost-effective. There was substantial uncertainty because confidence intervals around cost differences were wide and QALY effects were small.

Conclusion: Depression screening strategies for patients with ACS may be modestly cost-effective.
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http://dx.doi.org/10.1016/j.genhosppsych.2021.04.001DOI Listing
April 2021

Depression and Incident Cardiovascular Disease-Reply.

JAMA 2021 04;325(16):1680

Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.

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http://dx.doi.org/10.1001/jama.2021.2032DOI Listing
April 2021

Screening for Hypertension in Adults: US Preventive Services Task Force Reaffirmation Recommendation Statement.

JAMA 2021 04;325(16):1650-1656

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Hypertension is a prevalent condition that affects approximately 45% of the adult US population and is the most commonly diagnosed condition at outpatient office visits. Hypertension is a major contributing risk factor for heart failure, myocardial infarction, stroke, and chronic kidney disease.

Objective: To reaffirm its 2015 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for hypertension in adults, the accuracy of office blood pressure measurement for initial screening, and the accuracy of various confirmatory blood pressure measurement methods.

Population: Adults 18 years or older without known hypertension.

Evidence Assessment: Using a reaffirmation deliberation process, the USPSTF concludes with high certainty that screening for hypertension in adults has substantial net benefit.

Recommendation: The USPSTF recommends screening for hypertension in adults 18 years or older with office blood pressure measurement. The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment. (A recommendation).
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http://dx.doi.org/10.1001/jama.2021.4987DOI Listing
April 2021

Using a multistakeholder collaboratory and patient surveys to inform the conduct of personalized (N-of-1) trials.

Health Psychol 2021 Apr;40(4):230-241

Center for Behavioral Cardiovascular Health.

Objective: Personalized trials have the potential to improve the precision of treatment selection and foster patient involvement in clinical decision making. Little is known about the attitudes of patients with multimorbidities. To address this, stakeholders designed and conducted a national survey that determined general attitudes and features of personalized trials that may increase their use among patients with multimorbidities in clinical and research practice.

Method: A multistakeholder collaboratory of patients, clinicians, scientists, methodologists, statisticians, and research disseminators designed a survey to determine the conditions, symptoms, and design attributes most applicable to personalized trials according to patients. A sample of U.S. patients with two or more prespecified personalized-trial-amenable chronic conditions completed the online survey.

Results: Multimorbid participants (N = 501; M age = 56.1 years) showed that some conditions, symptoms or use cases for personalized trials include pain (57.6%), hypertension (38.8%), diabetes (28.8%), sleep problems (27.4%), and depression (23.0%). Overall, 82.0% of the participants with multimorbidities were interested in participating in personalized trials. The percentage that were interested varied by trial attributes, including physician involvement (86.4%), patient-driven treatment selection (88.0%), clinician blinding (59.2%), placebo treatment options (57.5%), and out-of-pocket costs (41.8%).

Conclusion: Participants with multimorbidities identified prevalent use cases that are suited to personalized trials. Participants also identified design features of such trials, including patient-driven treatment selection, active comparators, and nonblinding. This study demonstrates that eliciting input from a collaboratory and patients with multimorbidities can inform research priorities for this rapidly growing patient population and increase adoption by researchers and clinicians alike. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/hea0001058DOI Listing
April 2021

Screening for Vitamin D Deficiency in Adults: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 04;325(14):1436-1442

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Vitamin D is a fat-soluble vitamin that performs an important role in calcium homeostasis and bone metabolism and also affects many other cellular regulatory functions outside the skeletal system. Vitamin D requirements may vary by individual; thus, no one serum vitamin D level cutpoint defines deficiency, and no consensus exists regarding the precise serum levels of vitamin D that represent optimal health or sufficiency.

Objective: To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on screening for vitamin D deficiency, including the benefits and harms of screening and early treatment.

Population: Community-dwelling, nonpregnant adults who have no signs or symptoms of vitamin D deficiency or conditions for which vitamin D treatment is recommended.

Evidence Assessment: The USPSTF concludes that the overall evidence on the benefits of screening for vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults cannot be determined.

Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement).
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http://dx.doi.org/10.1001/jama.2021.3069DOI Listing
April 2021

Postdischarge thromboembolic outcomes and mortality of hospitalized patients with COVID-19: the CORE-19 registry.

Blood 2021 05;137(20):2838-2847

Institute of Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY.

Thromboembolic events, including venous thromboembolism (VTE) and arterial thromboembolism (ATE), and mortality from subclinical thrombotic events occur frequently in coronavirus disease 2019 (COVID-19) inpatients. Whether the risk extends postdischarge has been controversial. Our prospective registry included consecutive patients with COVID-19 hospitalized within our multihospital system from 1 March to 31 May 2020. We captured demographics, comorbidities, laboratory parameters, medications, postdischarge thromboprophylaxis, and 90-day outcomes. Data from electronic health records, health informatics exchange, radiology database, and telephonic follow-up were merged. Primary outcome was a composite of adjudicated VTE, ATE, and all-cause mortality (ACM). Principal safety outcome was major bleeding (MB). Among 4906 patients (53.7% male), mean age was 61.7 years. Comorbidities included hypertension (38.6%), diabetes (25.1%), obesity (18.9%), and cancer history (13.1%). Postdischarge thromboprophylaxis was prescribed in 13.2%. VTE rate was 1.55%; ATE, 1.71%; ΑCM, 4.83%; and MB, 1.73%. Composite primary outcome rate was 7.13% and significantly associated with advanced age (odds ratio [OR], 3.66; 95% CI, 2.84-4.71), prior VTE (OR, 2.99; 95% CI, 2.00-4.47), intensive care unit (ICU) stay (OR, 2.22; 95% CI, 1.78-2.93), chronic kidney disease (CKD; OR, 2.10; 95% CI, 1.47-3.0), peripheral arterial disease (OR, 2.04; 95% CI, 1.10-3.80), carotid occlusive disease (OR, 2.02; 95% CI, 1.30-3.14), IMPROVE-DD VTE score ≥4 (OR, 1.51; 95% CI, 1.06-2.14), and coronary artery disease (OR, 1.50; 95% CI, 1.04-2.17). Postdischarge anticoagulation was significantly associated with reduction in primary outcome (OR, 0.54; 95% CI, 0.47-0.81). Postdischarge VTE, ATE, and ACM occurred frequently after COVID-19 hospitalization. Advanced age, cardiovascular risk factors, CKD, IMPROVE-DD VTE score ≥4, and ICU stay increased risk. Postdischarge anticoagulation reduced risk by 46%.
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http://dx.doi.org/10.1182/blood.2020010529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8032474PMC
May 2021

Effectiveness of SARS-CoV-2 Decontamination and Containment in a COVID-19 ICU.

Int J Environ Res Public Health 2021 03 3;18(5). Epub 2021 Mar 3.

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, NY 11549, USA.

Health care systems in the United States are continuously expanding and contracting spaces to treat patients with coronavirus disease 2019 (COVID-19) in intensive care units (ICUs). As a result, hospitals must effectively decontaminate and contain severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in constructed and deconstructed ICUs that care for patients with COVID-19. We assessed decontamination of a COVID-19 ICU and examined the containment efficacy of combined contact and droplet precautions in creating and maintaining a SARS-CoV-2-negative ICU "antechamber". To examine the efficacy of chemical decontamination, we used high-density, semi-quantitative environmental sampling to detect SARS-CoV-2 on surfaces in a COVID-19 ICU and COVID-19 ICU antechamber. Quantitative real-time polymerase chain reaction was used to measure viral RNA on surfaces. Viral location mapping revealed the distribution of viral RNA in the COVID-19 ICU and COVID-19 ICU antechamber. Results were further assessed using loop-mediated isothermal amplification. We collected 224 surface samples pre-decontamination and 193 samples post-decontamination from a COVID-19 ICU and adjoining COVID-19 ICU antechamber. We found that 46% of antechamber objects were positive for SARS-CoV-2 pre-decontamination despite the construction of a swinging door barrier system, implementation of contact precautions, and installation of high-efficiency particulate air filters. The object positivity rate reduced to 32.1% and viral particle rate reduced by 95.4% following decontamination. Matched items had an average of 432.2 ± 2729 viral copies/cm pre-decontamination and 19.2 ± 118 viral copies/cm post-decontamination, demonstrating significantly reduced viral surface distribution ( < 0.0001). Environmental sampling is an effective method for evaluating decontamination protocols and validating measures used to contain SARS-CoV-2 viral particles. While chemical decontamination effectively removes detectable viral RNA from surfaces, our approach to droplet/contact containment with an antechamber was not highly effective. These data suggest that hospitals should plan for the potential of aerosolized virions when creating strategies to contain SARS-CoV-2.
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http://dx.doi.org/10.3390/ijerph18052479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7967612PMC
March 2021

Screening for Hearing Loss in Older Adults: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 03;325(12):1196-1201

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Age-related sensorineural hearing loss is a common health problem among adults. Nearly 16% of US adults 18 years or older report difficulty hearing. The prevalence of perceived hearing loss increases with age. Hearing loss can adversely affect an individual's quality of life and ability to function independently and has been associated with increased risk of falls, hospitalizations, social isolation, and cognitive decline.

Objective: To update its 2012 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on screening for hearing loss in adults 50 years or older.

Population: Asymptomatic adults 50 years or older with age-related hearing loss.

Evidence Assessment: Because of a lack of evidence, the USPSTF concludes that the benefits and harms of screening for hearing loss in asymptomatic older adults are uncertain and that the balance of benefits and harms cannot be determined. More research is needed.

Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for hearing loss in older adults. (I statement).
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http://dx.doi.org/10.1001/jama.2021.2566DOI Listing
March 2021

Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 Mar;325(10):962-970

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Lung cancer is the second most common cancer and the leading cause of cancer death in the US. In 2020, an estimated 228 820 persons were diagnosed with lung cancer, and 135 720 persons died of the disease. The most important risk factor for lung cancer is smoking. Increasing age is also a risk factor for lung cancer. Lung cancer has a generally poor prognosis, with an overall 5-year survival rate of 20.5%. However, early-stage lung cancer has a better prognosis and is more amenable to treatment.

Objective: To update its 2013 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the accuracy of screening for lung cancer with low-dose computed tomography (LDCT) and on the benefits and harms of screening for lung cancer and commissioned a collaborative modeling study to provide information about the optimum age at which to begin and end screening, the optimal screening interval, and the relative benefits and harms of different screening strategies compared with modified versions of multivariate risk prediction models.

Population: This recommendation statement applies to adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

Evidence Assessment: The USPSTF concludes with moderate certainty that annual screening for lung cancer with LDCT has a moderate net benefit in persons at high risk of lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking.

Recommendation: The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. (B recommendation) This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.
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http://dx.doi.org/10.1001/jama.2021.1117DOI Listing
March 2021

Overcoming challenges in preventive cardiology research.

Eur J Prev Cardiol 2020 Jun 2. Epub 2020 Jun 2.

Department of Medicine, Northwell Health, USA.

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http://dx.doi.org/10.1177/2047487320928175DOI Listing
June 2020

Experimental Designs to Optimize Treatments for Individuals: Personalized N-of-1 Trials.

JAMA Pediatr 2021 Apr;175(4):404-409

Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York.

Conventional randomized clinical trials (RCTs) compare treatment effectiveness to provide support for evidence-based treatments that can be generalized to the average patient. However, the information obtained from RCTs may not always be useful for selecting the best treatment for individual patients. This article presents a complementary approach to identifying optimized treatments using experimental designs that focus on individuals. Personalized, or N-of-1, designs provide both a comparative analysis of treatments and a functional analysis demonstrating that changes in patient symptoms are likely because of the treatment implemented. This approach contributes to the zeitgeist of personalized medicine and provides clinicians with a paradigm for investigating optimal treatments for rare diseases for which RCTs are not always feasible, identifying personally effective treatments for patients with comorbidities who have historically been excluded from most RCTs, handling clinical situations in which patients respond idiosyncratically (either positively or negatively) to treatment, and shortening the time lag between identification and implementation of an evidence-based treatment. These designs merge experimental analysis of behavior methods used for decades in psychology with new methodological and statistical advances to assess significance levels of changes in individual patients, and they can be generalized to larger populations for meta-analytic purposes. This article presents a case for why these models are needed, an overview of how to apply personalized designs for different types of clinical scenarios, and a brief discussion of challenges associated with interpretation and implementation of personalized designs. The goal is to empower pediatricians to take personalized trial designs into clinical practice to identify optimal treatments for their patients.
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http://dx.doi.org/10.1001/jamapediatrics.2020.5801DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351788PMC
April 2021

Examination of patient characteristics and hydroxychloroquine use based on the US Food and Drug Administration's recommendation: a cross-sectional analysis in New York.

BMJ Open 2021 02 8;11(2):e042965. Epub 2021 Feb 8.

Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health, Hempstead, New York, USA

Objective: To describe the pattern of hydroxychloroquine use and examine the association between hydroxychloroquine use and clinical outcomes arising from changes in the US Food and Drug Administration (FDA)'s recommendation during the coronavirus disease 2019 (COVID-19) pandemic.

Design: A retrospective cross-sectional analysis.

Setting And Participants: We included hospitalised adult patients at Northwell Health hospitals with confirmed COVID-19 infections between 1 March 2020 and 11 May 2020. We categorised changes in the FDA's recommendation as pre-FDA approval (1 March 2020-27 March 2020), FDA approval (28 March 2020-23 April 2020), and FDA warning (24 April 2020-11 May 2020). The hydroxychloroquine-treated group received at least one dose within 48 hours of hospital admission.

Primary Outcome: A composite of intubation and inpatient death.

Results: The percentages of patients who were treated with hydroxychloroquine were 192/2202 (8.7%) pre-FDA approval, 2902/6741 (43.0%) FDA approval, and 176/1066 (16.5%) FDA warning period (p<0.001). Using propensity score matching, there was a higher rate of the composite outcome among patients treated with hydroxychloroquine (49/192, 25.5%) compared with no hydroxychloroquine (66/384, 17.2%) in the pre-FDA approval period (p=0.03) but not in the FDA approval period (25.5% vs 22.6%, p=0.08) or the FDA warning (21.0% vs 15.1%, p=0.11) periods. Coincidently, there was an increase in number of patients with COVID-19 and disease severity during the FDA approval period (24.1% during FDA approval vs 21.4% during pre-FDA approval period had the composite outcome). Hydroxychloroquine use was associated with increased odds of the composite outcome during the pre-FDA approval period (OR=1.65 (95% CI 1.09 to 2.51)) but not during the FDA approval (OR=1.17 (95% CI 0.99 to 1.39)) and FDA warning (OR=1.50 (95% CI 0.94 to 2.39)) periods.

Conclusions: Hydroxychloroquine use was associated with adverse clinical outcomes only during the pre-FDA approval period but not during the FDA approval and warning periods, even after adjusting for concurrent changes in the percentage of patients with COVID-19 treated with hydroxychloroquine and the number (and disease severity) of hospitalised patients with COVID-19 infections.
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http://dx.doi.org/10.1136/bmjopen-2020-042965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7871686PMC
February 2021

Screening for Asymptomatic Carotid Artery Stenosis: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 02;325(5):476-481

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Carotid artery stenosis is atherosclerotic disease that affects extracranial carotid arteries. Asymptomatic carotid artery stenosis refers to stenosis in persons without a history of ischemic stroke, transient ischemic attack, or other neurologic symptoms referable to the carotid arteries. The prevalence of asymptomatic carotid artery stenosis is low in the general population but increases with age.

Objective: To determine if its 2014 recommendation should be reaffirmed, the US Preventive Services Task Force (USPSTF) commissioned a reaffirmation evidence review. The reaffirmation update focused on the targeted key questions on the potential benefits and harms of screening and interventions, including revascularization procedures designed to improve carotid artery blood flow, in persons with asymptomatic carotid artery stenosis.

Population: This recommendation statement applies to adults without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms referable to the carotid arteries.

Evidence Assessment: The USPSTF found no new substantial evidence that could change its recommendation and therefore concludes with moderate certainty that the harms of screening for asymptomatic carotid artery stenosis outweigh the benefits.

Recommendation: The USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general adult population. (D recommendation).
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http://dx.doi.org/10.1001/jama.2020.26988DOI Listing
February 2021

Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: US Preventive Services Task Force Recommendation Statement.

JAMA 2021 Jan;325(3):265-279

Tufts University School of Medicine, Boston, Massachusetts.

Importance: Tobacco use is the leading preventable cause of disease, disability, and death in the US. In 2014, it was estimated that 480 000 deaths annually are attributed to cigarette smoking, including second hand smoke exposure. Smoking during pregnancy can increase the risk of numerous adverse pregnancy outcomes (eg, miscarriage and congenital anomalies) and complications in the offspring (including sudden infant death syndrome and impaired lung function in childhood). In 2019, an estimated 50.6 million US adults (20.8% of the adult population) used tobacco; 14.0% of the US adult population currently smoked cigarettes and 4.5% of the adult population used electronic cigarettes (e-cigarettes). Among pregnant US women who gave birth in 2016, 7.2% reported smoking cigarettes while pregnant.

Objective: To update its 2015 recommendation, the USPSTF commissioned a review to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons.

Population: This recommendation statement applies to adults 18 years or older, including pregnant persons.

Evidence Assessment: The USPSTF concludes with high certainty that the net benefit of behavioral interventions and US Food and Drug Associated (FDA)-approved pharmacotherapy for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial. The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial. The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized clinical trials on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence.

Recommendations: The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and FDA-approved pharmacotherapy for cessation to nonpregnant adults who use tobacco. (A recommendation) The USPSTF recommends that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco. (A recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant persons. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of e-cigarettes for tobacco cessation in adults, including pregnant persons. The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety. (I statement).
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http://dx.doi.org/10.1001/jama.2020.25019DOI Listing
January 2021
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