Journal: Ann Intern Med

Sorted by: date / impact
Abstract

Benefits and Risks Associated With Continuation of Anti-Tumor Necrosis Factor After 24 Weeks of Pregnancy in Women With Inflammatory Bowel Disease : A Nationwide Emulation Trial.

Meyer A, Neumann A, Drouin J, Weill A, Carbonnel F, Dray-Spira R
Background
Continuation of biologics for inflammatory disorders during pregnancy is still a difficult decision. Many women with inflammatory bowel diseases (IBDs) stop anti-tumor necrosis factor (anti-TNF) treatment after 24 weeks.
Objective
To evaluate the benefits and risks of anti-TNF continuation after 24 weeks of pregnancy for mothers with IBD and their offspring.
Design
Target trial emulation between 2010 and 2020.
Setting
Nationwide population-based study using the Système National des Données de Santé.
Patients
All pregnancies with birth exposed to anti-TNF between conception and 24 weeks of pregnancy in women with IBD.
Intervention
Continuation of anti-TNF after 24 weeks of pregnancy.
Measurements
Occurrence of maternal IBD relapse up to 6 months after pregnancy, adverse pregnancy outcomes, and serious infections in the offspring during the first 5 years of life was compared according to anti-TNF continuation after 24 weeks of pregnancy using inverse probability-weighted marginal models.
Results
A total of 5293 pregnancies were included; among them, anti-TNF treatment was discontinued before 24 weeks for 2890 and continued beyond 24 weeks for 2403. Continuation of anti-TNF was associated with decreased frequencies of maternal IBD relapse (35.8% vs. 39.0%; adjusted risk ratio [aRR], 0.93 [95% CI, 0.86 to 0.99]) and prematurity (7.6% vs. 8.9%; aRR, 0.82 [CI, 0.68 to 0.99]). No difference according to anti-TNF continuation was found regarding stillbirths (0.4% vs. 0.2%; aRR, 2.16 [CI, 0.64 to 7.81]), small weight for gestational age births (13.1% vs. 12.9%; aRR, 1.01 [CI, 0.88 to 1.17]), and serious infections in the offspring (54.2 vs. 50.2 per 1000 person-years; adjusted hazard ratio, 1.08 [CI, 0.94 to 1.25]).
Limitation
Algorithms rather than clinical data were used to identify patients with IBD, pregnancies, and serious infections.
Conclusion
Continuation of anti-TNF after 24 weeks of pregnancy appears beneficial regarding IBD activity and prematurity, while not affecting neonatal outcomes and serious infections in the offspring.
Primary funding source
None.



Ann Intern Med: 27 Sep 2022; epub ahead of print
Meyer A, Neumann A, Drouin J, Weill A, Carbonnel F, Dray-Spira R
Ann Intern Med: 27 Sep 2022; epub ahead of print | PMID: 36162111
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Evaluation of Harms Reporting in U.S. Cancer Screening Guidelines.

Kamineni A, Doria-Rose VP, Chubak J, Inadomi JM, ... Croswell JM, Burnett-Hartman AN
Background
Cancer screening should be recommended only when the balance between benefits and harms is favorable. This review evaluated how U.S. cancer screening guidelines reported harms, within and across organ-specific processes to screen for cancer.
Objective
To describe current reporting practices and identify opportunities for improvement.
Design
Review of guidelines.
Setting
United States.
Patients
Patients eligible for screening for breast, cervical, colorectal, lung, or prostate cancer according to U.S. guidelines.
Measurements
Information was abstracted on reporting of patient-level harms associated with screening, diagnostic follow-up, and treatment. The authors classified harms reporting as not mentioned, conceptual, qualitative, or quantitative and noted whether literature was cited when harms were described. Frequency of harms reporting was summarized by organ type.
Results
Harms reporting was inconsistent across organ types and at each step of the cancer screening process. Guidelines did not report all harms for any specific organ type or for any category of harm across organ types. The most complete harms reporting was for prostate cancer screening guidelines and the least complete for colorectal cancer screening guidelines. Conceptualization of harms and use of quantitative evidence also differed by organ type.
Limitations
This review considers only patient-level harms. The authors did not verify accuracy of harms information presented in the guidelines.
Conclusion
The review identified opportunities for improving conceptualization, assessment, and reporting of screening process-related harms in guidelines. Future work should consider nuances associated with each organ-specific process to screen for cancer, including which harms are most salient and where evidence gaps exist, and explicitly explore how to optimally weigh available evidence in determining net screening benefit. Improved harms reporting could aid informed decision making, ultimately improving cancer screening delivery.
Primary funding source
National Cancer Institute.



Ann Intern Med: 27 Sep 2022; epub ahead of print
Kamineni A, Doria-Rose VP, Chubak J, Inadomi JM, ... Croswell JM, Burnett-Hartman AN
Ann Intern Med: 27 Sep 2022; epub ahead of print | PMID: 36162112
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Adenoma Detection Rate and Risk for Interval Postcolonoscopy Colorectal Cancer in Fecal Immunochemical Test-Based Screening : A Population-Based Cohort Study.

Wisse PHA, Erler NS, de Boer SY, den Hartog B, ... Dekker E, Spaander MCW
Background
The adenoma detection rate (ADR) is an essential quality indicator for endoscopists performing colonoscopies for colorectal cancer (CRC) screening as it is associated with postcolonoscopy CRCs (PCCRCs). Currently, data on ADRs of endoscopists performing colonoscopies in fecal immunochemical testing (FIT)-based screening, the most common screening method, are scarce. Also, the association between the ADR and PCCRC has not been demonstrated in this setting.
Objective
To evaluate the association between the ADR and PCCRC risk in colonoscopies done after a positive FIT result.
Design
Population-based cohort.
Setting
Dutch, FIT-based, CRC screening program.
Participants
Patients undergoing colonoscopy, done by accredited endoscopists, after a positive FIT result.
Measurements
Quality indicator performance and PCCRC incidence for colonoscopies in FIT-positive screenees were assessed. The PCCRCs were classified as interval, a cancer detected before recommended surveillance, or noninterval. The association between ADR and interval PCCRC was evaluated with a multivariable Cox regression model and PCCRC incidence was determined for different ADRs.
Results
362 endoscopists performed 116 360 colonoscopies with a median ADR of 67%. In total, 209 interval PCCRCs were identified. The ADR was associated with interval PCCRC, with an adjusted hazard ratio of 0.95 (95% CI, 0.92 to 0.97) per 1% increase in ADR. For every 1000 patients undergoing colonoscopy, the expected number of interval PCCRC diagnoses after 5 years was approximately 2 for endoscopists with ADRs of 70%, compared with more than 2.5, almost 3.5, and more than 4.5 for endoscopists with ADRs of 65%, 60%, and 55%, respectively.
Limitation
The relative short duration of follow-up (median, 52 months) could be considered a limitation.
Conclusion
The ADR of endoscopists is inversely associated with the risk for interval PCCRC in FIT-positive colonoscopies. Endoscopists performing colonoscopy in FIT-based screening should aim for markedly higher ADRs compared with primary colonoscopy.
Primary funding source
None.



Ann Intern Med: 27 Sep 2022; epub ahead of print
Wisse PHA, Erler NS, de Boer SY, den Hartog B, ... Dekker E, Spaander MCW
Ann Intern Med: 27 Sep 2022; epub ahead of print | PMID: 36162114
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Patient-Reported Outcomes Measures in Cardiovascular Disease: An Evidence Map of the Psychometric Properties of Health Status Instruments.

Chew DS, Whitelaw S, Vaduganathan M, Mark DB, Van Spall HGC
Background
Patient-reported outcomes (PROs) are important measures of treatment effect and can be used to inform the approval of cardiovascular drugs and devices by the U.S. Food and Drug Administration (FDA).
Purpose
To catalogue the health status patient-reported outcome measures (PROMs) validated in cardiovascular diseases (CVDs), describe their psychometric properties, and assess adherence with both FDA recommendations and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework.
Data sources
MEDLINE, EMBASE, CINAHL, and Allied and Complementary Medicine Database from inception to August 2022.
Study selection
Studies that developed and/or validated health status PROMs in CVD populations.
Data extraction
Two study authors extracted data on CVD type, PROM psychometric properties, and adherence to FDArecommendations. The risk of bias informing the development or validation of PROMs was assessed using the COSMIN framework.
Data synthesis
Fifty health status PROMs (described in 83 studies) were identified, of which 45 were disease specific and 5 were generic. Eleven (22%) of the 50 PROMs validated in CVDs had minimally important differences (MIDs) established, and 8 (16%) reported on the validation of all psychometric properties recommended by the FDA. By COSMIN standards, only 2 PROMs (4%) had all of their psychometric properties rated as sufficient in quality, and 32 PROMs (64%) had less than 50% of psychometric properties rated as sufficient.
Limitation
The quality of reporting varied across included studies.
Conclusion
Of 50 PROMs validated in CVDs, only a small minority reported on the validation of all FDA-recommended psychometric properties, had psychometric properties rated as sufficient by COSMIN, or had MIDs established. Given the use of PROMs to guide FDA approvals of drugs and devices in CVDs, there is a need for better adherence to quality standards in PROM validation.
Primary funding source
None.



Ann Intern Med: 20 Sep 2022; epub ahead of print
Chew DS, Whitelaw S, Vaduganathan M, Mark DB, Van Spall HGC
Ann Intern Med: 20 Sep 2022; epub ahead of print | PMID: 36122377
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis : A Randomized Clinical Trial.

Bennell KL, Schwartz S, Teo PL, Hawkins S, ... Hunter DJ, Hinman RS
Background
Yoga is a mind-body exercise typically done in groups in person, but this delivery method can be inconvenient, inaccessible, and costly. Effective online programs may increase access to exercise for knee osteoarthritis.
Objective
To evaluate the effectiveness of an unsupervised 12-week online yoga program.
Design
Two-group superiority randomized trial. (Australian New Zealand Clinical Trials Registry: ACTRN12620000012976).
Setting
Community.
Participants
212 adults with symptomatic knee osteoarthritis.
Intervention
Both groups received online osteoarthritis information (control). The yoga group also received access to an unsupervised online yoga program delivered via prerecorded videos over 12 weeks (1 video per week, with each session to be performed 3 times per week), with optional continuation thereafter.
Measurements
Primary outcomes were changes in knee pain during walking (0 to 10 on a numerical rating scale) and physical function (0 to 68 on the Western Ontario and McMaster Universities Osteoarthritis Index) at 12 weeks (primary time point) and 24 weeks, analyzed using mixed-effects linear regression models. Secondary outcomes were self-reported overall knee pain, stiffness, depression, anxiety, stress, global change, quality of life, self-efficacy, fear of movement, and balance confidence. Adverse events were also collected.
Results
A total of 195 (92%) and 189 (89%) participants provided 12- and 24-week primary outcomes, respectively. Compared with control at 12 weeks, yoga improved function (between-group mean difference in change, -4.0 [95% CI, -6.8 to -1.3]) but not knee pain during walking (between-group mean difference in change, -0.6 [CI, -1.2 to 0.1]), with more yoga participants than control participants achieving the minimal clinically important difference (MCID) for both outcomes. At 12 weeks, knee stiffness, quality of life, and arthritis self-efficacy improved more with yoga than the control intervention. Benefits were not maintained at 24 weeks. Adverse events were minor.
Limitation
Participants were unblinded.
Conclusion
Compared with online education, an unsupervised online yoga program improved physical function but not knee pain at 12 weeks in people with knee osteoarthritis, although the improvement did not reach the MCID and was not sustained at 24 weeks.
Primary funding source
National Health and Medical Research Council and Centres of Research Excellence.



Ann Intern Med: 20 Sep 2022; epub ahead of print
Bennell KL, Schwartz S, Teo PL, Hawkins S, ... Hunter DJ, Hinman RS
Ann Intern Med: 20 Sep 2022; epub ahead of print | PMID: 36122378
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

The Management of Major Depressive Disorder: Synopsis of the 2022 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline.

McQuaid JR, Buelt A, Capaldi V, Fuller M, ... Wiechers IR, Williams S
Description
In February 2022, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved a joint clinical practice guideline (CPG) for the management of major depressive disorder (MDD). This synopsis summarizes key recommendations.
Methods
Senior leaders within the VA and the DoD assembled a team to update the 2016 CPG for the management of MDD that included clinical stakeholders and conformed to the National Academy of Medicine\'s tenets for trustworthy CPGs. The guideline panel developed key questions, systematically searched and evaluated the literature, created two 1-page algorithms, and distilled 36 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. Select recommendations that were identified by the authors to represent key changes from the prior CPG are presented in this synopsis.
Recommendations
The scope of the CPG is diverse; however, this synopsis focuses on key recommendations that the authors identified as important new evidence and changes to prior recommendations on pharmacologic management, pharmacogenomics, psychotherapy, complementary and alternative therapies, and the use of telemedicine.



Ann Intern Med: 20 Sep 2022; epub ahead of print
McQuaid JR, Buelt A, Capaldi V, Fuller M, ... Wiechers IR, Williams S
Ann Intern Med: 20 Sep 2022; epub ahead of print | PMID: 36122380
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Deep Venous Thrombosis.

Duffett L
Venous thromboembolism (VTE) is the third most common cardiovascular disorder, affecting up to 5% of the population. VTE commonly manifests as lower-extremity deep venous thrombosis (DVT) or pulmonary embolism. Half of these events are associated with a transient risk factor and may be preventable with prophylaxis. Direct oral anticoagulants are effective and safe and carry a lower risk for bleeding than vitamin K antagonists. Many patients with VTE will have a chronic disease requiring long-term anticoagulation. Postthrombotic syndrome affects 25% to 40% of patients with DVT and significantly impacts function and quality of life.



Ann Intern Med: 13 Sep 2022; epub ahead of print
Duffett L
Ann Intern Med: 13 Sep 2022; epub ahead of print | PMID: 36095313
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Development and Validation of the Summary Elixhauser Comorbidity Score for Use With ICD-10-CM-Coded Data Among Older Adults.

Mehta HB, Li S, An H, Goodwin JS, Alexander GC, Segal JB
Background
Older adults have many comorbidities contributing to mortality.
Objective
To develop a summary Elixhauser (S-Elixhauser) comorbidity score to predict 30-day, in-hospital, and 1-year mortality in older adults using the 38 comorbidities operationalized by the Agency for Healthcare Research and Quality (AHRQ).
Design
Retrospective cohort study.
Setting
Medicare beneficiaries from 2017 to 2019.
Patients
Persons hospitalized in 2018 (n = 899 844) and 3 disease-specific hospitalized cohorts.
Measurements
Weights were derived for 38 comorbidities to predict 30-day, in-hospital, and 1-year mortality. The S-Elixhauser score was internally validated and calibrated. Individual Elixhauser comorbidity indicators (38 comorbidities), the modified application of the AHRQ-derived Elixhauser summary score, the Charlson comorbidity indicators (17 comorbidities), and the Charlson summary score were externally validated. The c-statistic was used to evaluate discrimination of a comorbidity score model.
Results
The S-Elixhauser score was well calibrated and internally validated, with a c-statistic of 0.705 (95% CI, 0.703 to 0.707) in predicting 30-day mortality, 0.654 (CI, 0.651 to 0.657) for in-hospital mortality, and 0.743 (CI, 0.741 to 0.744) for 1-year mortality. In external validation of other comorbidity indices for 30-day mortality, the c-statistic was 0.711 (CI, 0.709 to 0.713) for the individual Elixhauser comorbidity indicators, 0.688 (CI, 0.686 to 0.690) for the AHRQ Elixhauser score, 0.696 (CI, 0.694 to 0.698) for the Charlson comorbidity indicators, and 0.690 (CI, 0.688 to 0.693) for the Charlson summary score. In 3 disease-specific populations, the discrimination of the S-Elixhauser score in predicting 30-day mortality ranged from 0.657 to 0.732.
Limitation
Validation of the S-Elixhauser comorbidity score and head-to-head comparison with other comorbidity scores in an external population are needed to evaluate comparative performance.
Conclusion
The S-Elixhauser comorbidity score is well calibrated and internally validated but its advantage over the AHRQ Elixhauser and Charlson summary scores is unclear.
Primary funding source
National Institute on Aging.



Ann Intern Med: 13 Sep 2022; epub ahead of print
Mehta HB, Li S, An H, Goodwin JS, Alexander GC, Segal JB
Ann Intern Med: 13 Sep 2022; epub ahead of print | PMID: 36095314
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population : A Cross-Sectional Study.

Jing Y, Hu J, Luo R, Mao Y, ... Li Q, Yang S
Background
With the widespread use of advanced imaging technology, adrenal tumors are increasingly being identified.
Objective
To investigate the prevalence and characteristics of adrenal tumors in an unselected screening population in China.
Design
Cross-sectional study. (ClinicalTrials.gov: NCT04682938).
Setting
A health examination center in China.
Patients
Adults having an annual checkup were invited to be screened for adrenal tumors by adrenal computed tomography.
Measurements
The participants with adrenal tumors had further evaluation for malignancy risk and adrenal function.
Results
A total of 25 356 participants were screened, 351 of whom were found to have adrenal tumors, for a prevalence of 1.4%. The prevalence increased with age, from 0.2% in participants aged 18 to 25 years to 3.2% in those older than 65 years. Among 351 participants with adrenal tumors, 337 were diagnosed with an adrenocortical adenoma, 14 with another benign nodule, and none with a malignant mass. In 212 participants with an adenoma who completed endocrine testing, 69.3% were diagnosed with a nonfunctioning adenoma, 18.9% with cortisol autonomy, 11.8% with primary aldosteronism, and none with pheochromocytoma. Proportions of nonfunctioning adenomas were similarly high in various age groups (72.2%, 67.8%, and 72.2% in those aged <46, 46 to 65, and ≥66 years, respectively).
Limitation
Only 212 of 337 participants with an adrenocortical adenoma had endocrine testing.
Conclusion
The prevalence of adrenal tumors in the general adult screening population is 1.4%, and most of these tumors are nonfunctioning regardless of patient age. Cortisol and aldosterone secretion are the main causes of functional adenomas.
Primary funding source
National Key Research and Development Program of China and National Natural Science Foundation of China.



Ann Intern Med: 13 Sep 2022; epub ahead of print
Jing Y, Hu J, Luo R, Mao Y, ... Li Q, Yang S
Ann Intern Med: 13 Sep 2022; epub ahead of print | PMID: 36095315
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In patients with CHD, a Mediterranean vs. low-fat diet reduced major CV events at 7 y.

Murff HJ
Source citation
Delgado-Lista J, Alcala-Diaz JF, Torres-Peña JD, et al. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022;399:1876-85. 35525255.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Murff HJ
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063545
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In older adults discharged from hospital, home-based exercise programs improve some outcomes.

Schattner A
Source citation
Lin I, Glinsky J, Dean C, et al. Effectiveness of home-based exercise for improving physical activity, quality of life and function in older adults after hospitalisation: a systematic review and meta-analysis. Clin Rehabil. 2022;36:1170-85. 35522200.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Schattner A
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063548
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Maternal, Infant, and Child Health Outcomes Associated with the Special Supplemental Nutrition Program for Women, Infants, and Children : A Systematic Review.

Venkataramani M, Ogunwole SM, Caulfield LE, Sharma R, ... Bass EB, Bennett WL
Background
The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is intended to improve maternal and child health outcomes. In 2009, the WIC food package changed to better align with national nutrition recommendations.
Purpose
To determine whether WIC participation was associated with improved maternal, neonatal-birth, and infant-child health outcomes or differences in outcomes by subgroups and WIC enrollment duration.
Data sources
Search (January 2009 to April 2022) included PubMed, Embase, CINAHL, ERIC, Scopus, PsycInfo, and the Cochrane Central Register of Controlled Trials.
Study selection
Included studies had a comparator of WIC-eligible nonparticipants or comparison before and after the 2009 food package change.
Data extraction
Paired team members independently screened articles for inclusion and evaluated risk of bias.
Data synthesis
We identified 20 observational studies. We found: moderate strength of evidence (SOE) that maternal WIC participation during pregnancy is likely associated with lower risk for preterm birth, low birthweight infants, and infant mortality; low SOE that maternal WIC participation may be associated with a lower likelihood of inadequate gestational weight gain, as well as increased well-child visits and childhood immunizations; and low SOE that child WIC participation may be associated with increased childhood immunizations. We found low SOE for differences in some outcomes by race and ethnicity but insufficient evidence for differences by WIC enrollment duration. We found insufficient evidence related to maternal morbidity and mortality outcomes.
Limitation
Data are from observational studies with high potential for selection bias related to the choice to participate in WIC, and participation status was self-reported in most studies.
Conclusion
Participation in WIC was likely associated with improved birth outcomes and lower infant mortality, and also may be associated with increased child preventive service receipt.
Primary funding source
Agency for Healthcare Research and Quality. (PROSPERO: CRD42020222452).



Ann Intern Med: 06 Sep 2022; epub ahead of print
Venkataramani M, Ogunwole SM, Caulfield LE, Sharma R, ... Bass EB, Bennett WL
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063550
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Early Rhythm Control Therapy for Atrial Fibrillation in Low-Risk Patients : A Nationwide Propensity Score-Weighted Study.

Kim D, Yang PS, You SC, Jang E, ... Sung JH, Joung B
Background
Rhythm control is associated with lower risk for adverse cardiovascular outcomes compared with usual care among patients recently diagnosed with atrial fibrillation (AF) with a CHA2DS2-VASc score of approximately 2 or greater in EAST-AFNET 4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial).
Objective
To investigate whether the results can be generalized to patients with low stroke risk.
Design
Population-based cohort study.
Setting
Nationwide claims database of the Korean National Health Insurance Service.
Participants
54 216 patients with AF having early rhythm control (antiarrhythmic drugs or ablation) or rate control therapy that was initiated within 1 year of the AF diagnosis.
Measurements
The effect of early rhythm control on the primary composite outcome of cardiovascular death, ischemic stroke, hospitalization for heart failure, or myocardial infarction was compared between eligible and ineligible patients for EAST-AFNET 4 (CHA2DS2-VASc score, approximately 0 to 1) using propensity overlap weighting.
Results
In total, 37 557 study participants (69.3%) were eligible for the trial (median age, 70 years; median CHA2DS2-VASc score, 4), among whom early rhythm control was associated with lower risk for the primary composite outcome than rate control (hazard ratio, 0.86 [95% CI, 0.81 to 0.92]). Among the 16 659 low-risk patients (30.7%) who did not meet the inclusion criteria (median age, 54 years; median CHA2DS2-VASc score, 1), early rhythm control was consistently associated with lower risk for the primary outcome (hazard ratio, 0.81 [CI, 0.66 to 0.98]). No significant differences in safety outcomes were found between the rhythm and rate control strategies regardless of trial eligibility.
Limitation
Residual confounding.
Conclusion
In routine clinical practice, the beneficial association between early rhythm control and cardiovascular complications was consistent among low-risk patients regardless of trial eligibility.
Primary funding source
The Ministry of Health and Welfare and the Ministry of Food and Drug Safety, Republic of Korea.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Kim D, Yang PS, You SC, Jang E, ... Sung JH, Joung B
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063552
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In ischemic stroke, IV alteplase within 3 h of onset improves functional outcome vs. control.

Eskin B
Source citation
Mun KT, Bonomo JB, Liebeskind DS, et al. Fragility index meta-analysis of randomized controlled trials shows highly robust evidential strength for benefit of < 3 hour intravenous alteplase. Stroke. 2022;53:2069-74. 35543129.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Eskin B
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063553
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In IgA nephropathy, oral methylprednisolone reduced adverse kidney outcomes but increased adverse events.

Hsu CY, Hsu RK
Source citation
Lv J, Wong MG, Hladunewich MA, et al. Effect of oral methylprednisolone on decline in kidney function or kidney failure in patients with IgA nephropathy: the TESTING randomized clinical trial. JAMA. 2022;327:1888-98. 35579642.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Hsu CY, Hsu RK
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063554
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In COVID-19 acute hypoxemia, awake prone positioning vs. usual care did not reduce intubation at 30 d.

Agarwal A, Martin GS
Source citation
Alhazzani W, Parhar KK, Weatherald J, et al. Effect of awake prone positioning on endotracheal intubation in patients with COVID-19 and acute respiratory failure: a randomized clinical trial. JAMA. 2022;327:2104-13. 35569448.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Agarwal A, Martin GS
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063555
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In older LTC residents, transitional care interventions vs. usual care reduce hospital readmissions.

Sewell M
Source citation
Birtwell K, Planner C, Hodkinson A, et al. Transitional care interventions for older residents of long-term care facilities: a systematic review and meta-analysis. JAMA Netw Open. 2022;5:e2210192. 35507344.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Sewell M
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063556
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In type 2 diabetes, SGLT2 inhibitors reduced risk for serious hyperkalemia without increasing hypokalemia.

Rachmasari K, Montori VM
Source citation
Neuen BL, Oshima M, Agarwal R, et al. Sodium-glucose cotransporter 2 inhibitors and risk of hyperkalemia in people with type 2 diabetes: a meta-analysis of individual participant data from randomized, controlled trials. Circulation. 2022;145:1460-70. 35394821.



Ann Intern Med: 06 Sep 2022; epub ahead of print
Rachmasari K, Montori VM
Ann Intern Med: 06 Sep 2022; epub ahead of print | PMID: 36063558
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

From Individualized Interactions to Standardized Schedules: A History of Time Organization in U.S. Outpatient Medicine.

Nguyen MT, Schotland SV, Howell JD
Many outpatient physicians and patients feel that current scheduling systems do not afford enough time for direct patient-physician interaction, leaving patients feeling unheard and physicians feeling demoralized. This dissatisfaction degrades patients\' trust in the health care system and contributes to workforce moral injury and burnout. In the hopes of understanding the roots of this time stress and helping to guide future decisions about how to organize physicians\' time, this article describes changes in the organization of U.S. outpatient physicians\' time, starting from care at home in the late 19th century. It discusses the origins of the appointment system, which was invented to be highly personalized, with assistants adjusting appointment durations to accommodate clinical activities, specific patient needs, and individual physician proclivities. The article then describes how centralization of appointment scheduling became more common as U.S. medicine became increasingly consolidated into larger and larger groups and health systems. This distanced schedulers from the people and care they were organizing and necessitated standardized appointment durations, which did not accommodate individual patient and physician needs. With the rise of managerialism, schedulers became increasingly accountable to administrators rather than patients and physicians. Whereas early appointment systems depended on personal connection between schedulers and the physicians and patients they supported, today\'s schedulers have few such interactions. The widespread shift to centralized scheduling and standardized time slots has contributed to misalignment among time allocation, patient care, and health care workforce well-being and is likely exacerbating ongoing tensions among patients, physicians, and administrators.



Ann Intern Med: 30 Aug 2022; epub ahead of print
Nguyen MT, Schotland SV, Howell JD
Ann Intern Med: 30 Aug 2022; epub ahead of print | PMID: 36037467
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

The Association of Baseline Plasma SARS-CoV-2 Nucleocapsid Antigen Level and Outcomes in Patients Hospitalized With COVID-19.

ACTIV-3/TICO Study Group*
Background
Levels of plasma SARS-CoV-2 nucleocapsid (N) antigen may be an important biomarker in patients with COVID-19 and enhance our understanding of the pathogenesis of COVID-19.
Objective
To evaluate whether levels of plasma antigen can predict short-term clinical outcomes and identify clinical and viral factors associated with plasma antigen levels in hospitalized patients with SARS-CoV-2.
Design
Cross-sectional study of baseline plasma antigen level from 2540 participants enrolled in the TICO (Therapeutics for Inpatients With COVID-19) platform trial from August 2020 to November 2021, with additional data on day 5 outcome and time to discharge.
Setting
114 centers in 10 countries.
Participants
Adults hospitalized for acute SARS-CoV-2 infection with 12 days or less of symptoms.
Measurements
Baseline plasma viral N antigen level was measured at a central laboratory. Delta variant status was determined from baseline nasal swabs using reverse transcriptase polymerase chain reaction. Associations between baseline patient characteristics and viral factors and baseline plasma antigen levels were assessed using both unadjusted and multivariable modeling. Association between elevated baseline antigen level of 1000 ng/L or greater and outcomes, including worsening of ordinal pulmonary scale at day 5 and time to hospital discharge, were evaluated using logistic regression and Fine-Gray regression models, respectively.
Results
Plasma antigen was below the level of quantification in 5% of participants at enrollment, and 1000 ng/L or greater in 57%. Baseline pulmonary severity of illness was strongly associated with plasma antigen level, with mean plasma antigen level 3.10-fold higher among those requiring noninvasive ventilation or high-flow nasal cannula compared with room air (95% CI, 2.22 to 4.34). Plasma antigen level was higher in those who lacked antispike antibodies (6.42 fold; CI, 5.37 to 7.66) and in those with the Delta variant (1.73 fold; CI, 1.41 to 2.13). Additional factors associated with higher baseline antigen level included male sex, shorter time since hospital admission, decreased days of remdesivir, and renal impairment. In contrast, race, ethnicity, body mass index, and immunocompromising conditions were not associated with plasma antigen levels. Plasma antigen level of 1000 ng/L or greater was associated with a markedly higher odds of worsened pulmonary status at day 5 (odds ratio, 5.06 [CI, 3.41 to 7.50]) and longer time to hospital discharge (median, 7 vs. 4 days; subhazard ratio, 0.51 [CI, 0.45 to 0.57]), with subhazard ratios similar across all levels of baseline pulmonary severity.
Limitations
Plasma samples were drawn at enrollment, not hospital presentation. No point-of-care test to measure plasma antigen is currently available.
Conclusion
Elevated plasma antigen is highly associated with both severity of pulmonary illness and clinically important patient outcomes. Multiple clinical and viral factors are associated with plasma antigen level at presentation. These data support a potential role of ongoing viral replication in the pathogenesis of SARS-CoV-2 in hospitalized patients.
Primary funding source
U.S. government Operation Warp Speed and National Institute of Allergy and Infectious Diseases.



Ann Intern Med: 30 Aug 2022; epub ahead of print
ACTIV-3/TICO Study Group*
Ann Intern Med: 30 Aug 2022; epub ahead of print | PMID: 36037469
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update.

DeTora LM, Toroser D, Sykes A, Vanderlinden C, ... Baltzer L, Citrome L
These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.



Ann Intern Med: 30 Aug 2022; epub ahead of print
DeTora LM, Toroser D, Sykes A, Vanderlinden C, ... Baltzer L, Citrome L
Ann Intern Med: 30 Aug 2022; epub ahead of print | PMID: 36037471
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Tea Consumption and All-Cause and Cause-Specific Mortality in the UK Biobank : A Prospective Cohort Study.

Inoue-Choi M, Ramirez Y, Cornelis MC, Berrington de González A, Freedman ND, Loftfield E
Background
Tea is frequently consumed worldwide, but the association of tea drinking with mortality risk remains inconclusive in populations where black tea is the main type consumed.
Objective
To evaluate the associations of tea consumption with all-cause and cause-specific mortality and potential effect modification by genetic variation in caffeine metabolism.
Design
Prospective cohort study.
Setting
The UK Biobank.
Participants
498 043 men and women aged 40 to 69 years who completed the baseline touchscreen questionnaire from 2006 to 2010.
Measurements
Self-reported tea intake and mortality from all causes and leading causes of death, including cancer, all cardiovascular disease (CVD), ischemic heart disease, stroke, and respiratory disease.
Results
During a median follow-up of 11.2 years, higher tea intake was modestly associated with lower all-cause mortality risk among those who drank 2 or more cups per day. Relative to no tea drinking, the hazard ratios (95% CIs) for participants drinking 1 or fewer, 2 to 3, 4 to 5, 6 to 7, 8 to 9, and 10 or more cups per day were 0.95 (95% CI, 0.91 to 1.00), 0.87 (CI, 0.84 to 0.91), 0.88 (CI, 0.84 to 0.91), 0.88 (CI, 0.84 to 0.92), 0.91 (CI, 0.86 to 0.97), and 0.89 (CI, 0.84 to 0.95), respectively. Inverse associations were seen for mortality from all CVD, ischemic heart disease, and stroke. Findings were similar regardless of whether participants also drank coffee or not or of genetic score for caffeine metabolism.
Limitation
Potentially important aspects of tea intake (for example, portion size and tea strength) were not assessed.
Conclusion
Higher tea intake was associated with lower mortality risk among those drinking 2 or more cups per day, regardless of genetic variation in caffeine metabolism. These findings suggest that tea, even at higher levels of intake, can be part of a healthy diet.
Primary funding source
National Cancer Institute Intramural Research Program.



Ann Intern Med: 30 Aug 2022; epub ahead of print
Inoue-Choi M, Ramirez Y, Cornelis MC, Berrington de González A, Freedman ND, Loftfield E
Ann Intern Med: 30 Aug 2022; epub ahead of print | PMID: 36037472
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Periconception Red Blood Cell Folate and Offspring Congenital Heart Disease : Nested Case-Control and Mendelian Randomization Studies.

Chen H, Zhang Y, Wang D, Chen X, ... Huang G, SPCC (Shanghai Preconception Cohort) Group†
Background
Periconception folic acid supplementation has been suggested to protect against congenital heart disease (CHD), but the association between maternal red blood cell (RBC) folate, the gold-standard biomarker of folate exposure, and subsequent offspring CHD risk is lacking.
Objective
To quantify the association between periconception maternal RBC folate and offspring CHD risk.
Design
Prospective, nested, case-control study and 1-sample Mendelian randomization. (ClinicalTrials.gov: NCT02737644).
Setting
29 maternity institutions in 12 districts of Greater Shanghai, China.
Participants
All 197 mothers of offspring with CHD and 788 individually matched mothers of unaffected offspring from the SPCC (Shanghai Preconception Cohort).
Measurements
Maternal RBC folate was measured before or at early pregnancy. Odds ratios [ORs] were estimated using conditional logistic regression after adjustment for covariates. Mendelian randomization was done using the methylenetetrahydrofolate reductase (MTHFR) C677T as the genetic instrument.
Results
Case patients had lower median maternal RBC folate concentrations than control participants (714 nmol/L [interquartile range, 482 to 1008 nmol/L] vs. 788 nmol/L [557 to 1094 nmol/L]). Maternal RBC folate concentrations were inversely associated with offspring CHD (adjusted OR per 100 nmol/L, 0.93 [95% CI, 0.89 to 0.99]). The adjusted OR for mothers with periconception RBC folate of 906 nmol/L or more (vs. <906 nmol/L) was 0.61 (CI, 0.40 to 0.93). Mendelian randomization showed that each 100-nmol increase in maternal RBC folate concentrations was significantly associated with reduced offspring CHD risk (OR, 0.75 [CI, 0.61 to 0.92]).
Limitation
Potential confounding due to unmeasured covariates in the nested case-control study.
Conclusion
Higher maternal RBC folate is associated with reduced offspring CHD risk. For primary CHD prevention, higher target RBC folate levels than currently recommended for neural tube defect prevention may be needed and warrant further study.
Primary funding source
National Key Research and Development Program of China, National Natural Science Foundation of China, China Postdoctoral Science Foundation, and Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences.



Ann Intern Med: 23 Aug 2022; epub ahead of print
Chen H, Zhang Y, Wang D, Chen X, ... Huang G, SPCC (Shanghai Preconception Cohort) Group†
Ann Intern Med: 23 Aug 2022; epub ahead of print | PMID: 35994746
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Risk for Myocardial Infarction, Stroke, and Pulmonary Embolism Following COVID-19 Vaccines in Adults Younger Than 75 Years in France.

Botton J, Jabagi MJ, Bertrand M, Baricault B, ... Zureik M, Dray-Spira R
Background
The BNT162b2 (Pfizer-BioNTech) vaccine has been shown to be safe with regard to risk for severe cardiovascular events (such as myocardial infarction [MI], pulmonary embolism [PE], and stroke) in persons aged 75 years or older. Less is known about the safety of other COVID-19 vaccines or outcomes in younger populations.
Objective
To assess short-term risk for severe cardiovascular events (excluding myocarditis and pericarditis) after COVID-19 vaccination in France\'s 46.5 million adults younger than 75 years.
Design
Self-controlled case series method adapted to event-dependent exposure and high event-related mortality.
Setting
France, 27 December 2020 to 20 July 2021.
Patients
All adults younger than 75 years hospitalized for PE, acute MI, hemorrhagic stroke, or ischemic stroke (n = 73 325 total events).
Measurements
Linkage between the French National Health Data System and COVID-19 vaccine databases enabled identification of hospitalizations for cardiovascular events (MI, PE, or stroke) and receipt of a first or second dose of the Pfizer-BioNTech, mRNA-1273 (Moderna), Ad26.COV2.S (Janssen), or ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccine. The relative incidence (RI) of each cardiovascular event was estimated in the 3 weeks after vaccination compared with other periods, with adjustment for temporality (7-day periods).
Results
No association was found between the Pfizer-BioNTech or Moderna vaccine and severe cardiovascular events. The first dose of the Oxford-AstraZeneca vaccine was associated with acute MI and PE in the second week after vaccination (RI, 1.29 [95% CI, 1.11 to 1.51] and 1.41 [CI, 1.13 to 1.75], respectively). An association with MI in the second week after a single dose of the Janssen vaccine could not be ruled out (RI, 1.75 [CI, 1.16 to 2.62]).
Limitations
It was not possible to ascertain the relative timing of injection and cardiovascular events on the day of vaccination. Outpatient deaths related to cardiovascular events were not included.
Conclusion
In persons aged 18 to 74 years, adenoviral-based vaccines may be associated with increased incidence of MI and PE. No association between mRNA-based vaccines and the cardiovascular events studied was observed.
Primary funding source
None.



Ann Intern Med: 23 Aug 2022; epub ahead of print
Botton J, Jabagi MJ, Bertrand M, Baricault B, ... Zureik M, Dray-Spira R
Ann Intern Med: 23 Aug 2022; epub ahead of print | PMID: 35994748
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma.

Estcourt LJ, Cohn CS, Pagano MB, Iannizzi C, ... Winters JL, Tobian AAR
Description
Coronavirus disease 2019 convalescent plasma (CCP) has emerged as a potential treatment of COVID-19. However, meta-analysis data and recommendations are limited. The Association for the Advancement of Blood and Biotherapies (AABB) developed clinical practice guidelines for the appropriate use of CCP.
Methods
These guidelines are based on 2 living systematic reviews of randomized controlled trials (RCTs) evaluating CCP from 1 January 2019 to 26 January 2022. There were 33 RCTs assessing 21 916 participants. The results were summarized using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. An expert panel reviewed the data using the GRADE framework to formulate recommendations.
Recommendation 1 (outpatient)
The AABB suggests CCP transfusion in addition to the usual standard of care for outpatients with COVID-19 who are at high risk for disease progression (weak recommendation, moderate-certainty evidence).
Recommendation 2 (inpatient)
The AABB recommends against CCP transfusion for unselected hospitalized persons with moderate or severe disease (strong recommendation, high-certainty evidence). This recommendation does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2.
Recommendation 3 (inpatient)
The AABB suggests CCP transfusion in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies detected at admission (weak recommendation, low-certainty evidence).
Recommendation 4 (inpatient)
The AABB suggests CCP transfusion in addition to the usual standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression (weak recommendation, low-certainty evidence).
Recommendation 5 (prophylaxis)
The AABB suggests against prophylactic CCP transfusion for uninfected persons with close contact exposure to a person with COVID-19 (weak recommendation, low-certainty evidence).
Good clinical practice statement
CCP is most effective when transfused with high neutralizing titers to infected patients early after symptom onset.



Ann Intern Med: 16 Aug 2022; epub ahead of print
Estcourt LJ, Cohn CS, Pagano MB, Iannizzi C, ... Winters JL, Tobian AAR
Ann Intern Med: 16 Aug 2022; epub ahead of print | PMID: 35969859
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis.

Chew DS, Zhou K, Pokorney SD, Matchar DB, ... Freeman JV, Piccini JP
Background
Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation.
Objective
To determine the optimal strategy for stroke prevention conditional on a patient\'s individual risks for ischemic stroke and bleeding.
Design
Decision analysis with a Markov model.
Data sources
Evidence from the published literature informed model inputs.
Target population
Women and men with nonvalvular AF and without prior stroke.
Time horizon
Lifetime.
Perspective
Clinical.
Intervention
LAAO versus warfarin or direct oral anticoagulants (DOACs).
Outcome measures
The primary end point was clinical benefit measured in quality-adjusted life-years.
Results of base-case analysis
The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA2DS2-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA2DS2-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs.
Results of sensitivity analysis
Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data.
Limitation
Clinical effectiveness data were drawn primarily from studies on the Watchman device.
Conclusion
Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO.
Primary funding source
None.



Ann Intern Med: 16 Aug 2022; epub ahead of print
Chew DS, Zhou K, Pokorney SD, Matchar DB, ... Freeman JV, Piccini JP
Ann Intern Med: 16 Aug 2022; epub ahead of print | PMID: 35969865
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial.

ACTIV-3/TICO Study Group*
Background
Ensovibep (MP0420) is a designed ankyrin repeat protein, a novel class of engineered proteins, under investigation as a treatment of SARS-CoV-2 infection.
Objective
To investigate if ensovibep, in addition to remdesivir and other standard care, improves clinical outcomes among patients hospitalized with COVID-19 compared with standard care alone.
Design
Double-blind, randomized, placebo-controlled, clinical trial. (ClinicalTrials.gov: NCT04501978).
Setting
Multinational, multicenter trial.
Participants
Adults hospitalized with COVID-19.
Intervention
Intravenous ensovibep, 600 mg, or placebo.
Measurements
Ensovibep was assessed for early futility on the basis of pulmonary ordinal scores at day 5. The primary outcome was time to sustained recovery through day 90, defined as 14 consecutive days at home or place of usual residence after hospital discharge. A composite safety outcome that included death, serious adverse events, end-organ disease, and serious infections was assessed through day 90.
Results
An independent data and safety monitoring board recommended that enrollment be halted for early futility after 485 patients were randomly assigned and received an infusion of ensovibep (n = 247) or placebo (n = 238). The odds ratio (OR) for a more favorable pulmonary outcome in the ensovibep (vs. placebo) group at day 5 was 0.93 (95% CI, 0.67 to 1.30; P = 0.68; OR > 1 would favor ensovibep). The 90-day cumulative incidence of sustained recovery was 82% for ensovibep and 80% for placebo (subhazard ratio [sHR], 1.06 [CI, 0.88 to 1.28]; sHR > 1 would favor ensovibep). The primary composite safety outcome at day 90 occurred in 78 ensovibep participants (32%) and 70 placebo participants (29%) (HR, 1.07 [CI, 0.77 to 1.47]; HR < 1 would favor ensovibep).
Limitation
The trial was prematurely stopped because of futility, limiting power for the primary outcome.
Conclusion
Compared with placebo, ensovibep did not improve clinical outcomes for hospitalized participants with COVID-19 receiving standard care, including remdesivir; no safety concerns were identified.
Primary funding source
National Institutes of Health.



Ann Intern Med: 09 Aug 2022; epub ahead of print
ACTIV-3/TICO Study Group*
Ann Intern Med: 09 Aug 2022; epub ahead of print | PMID: 35939810
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

How Would You Treat This Patient With Pulmonary Embolism? : Grand Rounds Discussion From Beth Israel Deaconess Medical Center.

Kanjee Z, Freed JA, Carroll BJ, Reynolds EE
Pulmonary embolism can be acutely life-threatening and is associated with long-term consequences such as recurrent venous thromboembolism and chronic thromboembolic pulmonary hypertension. In 2020, the American Society of Hematology published updated guidelines on the management of patients with venous thromboembolism. Here, a hematologist and a cardiology and vascular medicine specialist discuss these guidelines in the context of the care of a patient with pulmonary embolism. They discuss advanced therapies such as catheter-directed thrombolysis in the short-term management of patients with intermediate-risk disease, recurrence risk stratification at presentation, and ideal antithrombotic regimens for patients whose pulmonary embolism was associated with a transient minor risk factor.



Ann Intern Med: 09 Aug 2022; epub ahead of print
Kanjee Z, Freed JA, Carroll BJ, Reynolds EE
Ann Intern Med: 09 Aug 2022; epub ahead of print | PMID: 35939811
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy : A Cohort Study.

Grebely J, Dore GJ, Altice FL, Conway B, ... Robertson MN, Platt H
Background
Hepatitis C virus (HCV) reinfection after successful treatment may reduce the benefits of cure among people who inject drugs.
Objective
To evaluate the rate of HCV reinfection for 3 years after successful treatment among people receiving opioid agonist therapy (OAT).
Design
A 3-year, long-term, extension study of persons enrolled in the CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) study (ClinicalTrials.gov: NCT02105688).
Setting
55 clinical trial sites in 13 countries.
Patients
Aged 18 years and older with chronic HCV infection with genotypes 1, 4, or 6 receiving stable OAT.
Intervention
No treatments were administered.
Measurements
Serum samples were assessed for HCV reinfection. Urine drug screening was performed.
Results
Among 296 participants who received treatment, 286 were evaluable for reinfection and 199 were enrolled in the long-term extension study. The rate of HCV reinfection was 1.7 [95% CI, 0.8 to 3.0] per 100 person-years; 604 person-years of follow-up). A higher rate of reinfection was seen among people with recent injecting drug use (1.9 [95% CI, 0.5 to 4.8] per 100 person-years; 212 person-years). Ongoing drug use and injecting drug use were reported by 59% and 21% of participants, respectively, at the 6-month follow-up visit and remained stable during 3 years of follow-up.
Limitations
Participants were required to be 80% adherent to OAT at baseline and may represent a population with higher stability and lower risk for HCV reinfection. Rate of reinfection may be underestimated because all participants did not continue in the long-term extension study; whether participants who discontinued were at higher risk for reinfection is unknown.
Conclusion
Reinfection with HCV was low but was highest in the first 24 weeks after treatment completion and among people with ongoing injecting drug use and needle-syringe sharing.
Primary funding source
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.



Ann Intern Med: 09 Aug 2022; epub ahead of print
Grebely J, Dore GJ, Altice FL, Conway B, ... Robertson MN, Platt H
Ann Intern Med: 09 Aug 2022; epub ahead of print | PMID: 35939812
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Eating Disorders.

Uniacke B, Walsh BT
Eating disorders are common behavioral disorders associated with substantial psychological and physical morbidity and mortality. Persons with eating disorders frequently present to primary care providers, who may also be responsible for their general medical management. This article reviews the diagnosis, medical assessment, and treatment of the most common eating disorders.



Ann Intern Med: 09 Aug 2022; epub ahead of print
Uniacke B, Walsh BT
Ann Intern Med: 09 Aug 2022; epub ahead of print | PMID: 35939813
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In diabetes, some statins reduce non-HDL-C better than others vs. placebo.

Tanner M
Source citation
Hodkinson A, Tsimpida D, Kontopantelis E, et al. Comparative effectiveness of statins on non-high density lipoprotein cholesterol in people with diabetes and at risk of cardiovascular disease: systematic review and network meta-analysis. BMJ. 2022;376:e067731. 35331984.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Tanner M
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914251
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Recommendations for use of ezetimibe and/or PCSK9 inhibitors in patients with elevated LDL-C.

Kelsey MD, Newby LK
Source citation
Hao Q, Aertgeerts B, Guyatt G, et al. PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations. BMJ. 2022;377:e069066. 35508320.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Kelsey MD, Newby LK
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914252
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Evaluating the Performance of Centers for Disease Control and Prevention COVID-19 Community Levels as Leading Indicators of COVID-19 Mortality.

Salomon JA, Bilinski A
Background
Centers for Disease Control and Prevention (CDC) defines low, medium, and high \"COVID-19 community levels\" to guide interventions, but associated mortality rates have not been reported.
Objective
To evaluate the diagnostic performance of CDC COVID-19 community level metrics as predictors of elevated community mortality risk.
Design
Time series analysis over the period of 30 May 2021 through 4 June 2022.
Setting
U.S. states and counties.
Participants
U.S. population.
Measurements
CDC \"COVID-19 community level\" metrics based on hospital admissions, bed occupancy, and reported cases; reported COVID-19 deaths; and sensitivity, specificity, and predictive values for CDC and alternative metrics.
Results
Mean and median weekly mortality rates per 100 000 population after onset of high COVID-19 community level 3 weeks prior were 2.6 and 2.4, respectively, (interquartile range [IQR], 1.7 to 3.1) across 90 high episodes in states and 4.3 and 2.1, respectively, (IQR, 0 to 5.4) across 7987 high episodes in counties. In 85 of 90 (94%) episodes in states and 4801 of 7987 (60%) episodes in counties, lagged weekly mortality after onset exceeded 0.9 per 100 000 population, and in 57 of 90 (63%) episodes in states and 4018 of 7987 (50%) episodes in counties, lagged weekly mortality after onset exceeded 2.1 per 100 000, which is equivalent to approximately 1000 daily deaths in the national population. Alternative metrics based on lower hospital admissions or case thresholds were associated with lower mortality and had higher sensitivity and negative predictive value for elevated mortality, but the CDC metrics had higher specificity and positive predictive value. Ratios between cases, hospitalizations, and deaths have varied substantially over time.
Limitations
Aggregate mortality does not account for nonfatal outcomes or disparities. Continuing evolution of viral variants, immunity, clinical interventions, and public health mitigation strategies complicate prediction for future waves.
Conclusion
Designing metrics for public health decision making involves tradeoffs between identifying early signals for action and avoiding undue restrictions when risks are modest. Explicit frameworks for evaluating surveillance metrics can improve transparency and decision support.
Primary funding source
Council of State and Territorial Epidemiologists.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Salomon JA, Bilinski A
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914253
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Reduced dietary sodium did not reduce clinical events in heart failure.

Alvarado F, Borzak S
Source citation
Ezekowitz JA, Colin-Ramirez E, Ross H, et al. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial. Lancet. 2022;399:1391-400. 35381194.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Alvarado F, Borzak S
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914255
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In IBS, a smartphone application for self-managing a FODMAP-lowering diet vs. otilonium bromide reduced symptoms at 8 wk.

Cox JF
Source citation
Carbone F, Van den Houte K, Besard L, et al. Diet or medication in primary care patients with IBS: the DOMINO study-a randomised trial supported by the Belgian Health Care Knowledge Centre (KCE Trials Programme) and the Rome Foundation Research Institute. Gut. 2022. [Epub ahead of print]. 35483886.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Cox JF
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914257
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Preventing Obesity in Midlife Women: A Systematic Review for the Women\'s Preventive Services Initiative.

Cantor AG, Nelson HD, Pappas M, Atchison C
Background
Despite high prevalence rates of obesity in the United States, no clinical guidelines exist for obesity prevention in midlife women who commonly experience weight gain.
Purpose
To evaluate evidence on the effectiveness and harms of behavioral interventions to reduce weight gain and improve health outcomes for women aged 40 to 60 years without obesity.
Data sources
English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (inception to 26 October 2021); ClinicalTrials.gov (October 2021); and reference lists of studies and reviews.
Study selection
Randomized controlled trials (RCTs) enrolling predominantly midlife women comparing behavioral interventions to prevent weight gain with control groups and reporting health outcomes and potential harms.
Data extraction
Dual extraction and quality assessment of individual studies.
Data synthesis
Seven RCTs in 12 publications (n = 51 638) were included. Four RCTs showed statistically significant favorable differences in weight change for counseling interventions versus control groups (mean difference of weight change, -0.87 to -2.5 kg), whereas 1 trial of counseling and 2 trials of exercise showed no differences; 1 of 2 RCTs reported improved quality-of-life measures. Interventions did not increase measures of depression or stress in 1 trial; self-reported falls (37% vs. 29%; P < 0.001) and injuries (19% vs. 14%; P = 0.03) were higher with exercise counseling in 1 trial.
Limitation
Trials were generally small, heterogeneous, and lacked data on harms, long-term health outcomes, and specific patient populations.
Conclusion
Counseling interventions to prevent weight gain in women during midlife may result in modest differences in weight change without causing important harms. More research is needed to determine optimal content, frequency, length, and number of sessions required and should include additional patient populations.
Primary funding source
Health Resources and Services Administration.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Cantor AG, Nelson HD, Pappas M, Atchison C
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914258
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In drug-refractory IBS, group CBT with interoceptive exposure improved symptoms and QoL at 13 wk.

Oliver D, Talley NJ
Source citation
Kikuchi S, Oe Y, Ito Y, et al. Group cognitive-behavioral therapy with interoceptive exposure for drug-refractory irritable bowel syndrome: a randomized controlled trial. Am J Gastroenterol. 2022;117:668-77. 35103022.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Oliver D, Talley NJ
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914262
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Preventing Obesity in Midlife Women: A Recommendation From the Women\'s Preventive Services Initiative.

Chelmow D, Gregory KD, Witkop C, Hoffstetter S, ... Zahn C, Women\'s Preventive Services Initiative*
Description
The Women\'s Preventive Services Initiative (WPSI), a national coalition of women\'s health professional organizations and patient advocacy representatives, developed a recommendation for counseling midlife women aged 40 to 60 years with normal or overweight body mass index (BMI; 18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity with the long-term goals of optimizing health, function, and well-being. This recommendation is intended to guide clinical practice and coverage of clinical preventive health services for the Health Resources and Services Administration and other stakeholders. Clinicians providing preventive health care to women in primary care settings are the target audience for this recommendation.
Methods
The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness and harms of interventions to prevent weight gain and obesity in women aged 40 to 60 years without obesity. Seven randomized clinical trials including 51 638 participants and using various counseling and behavioral interventions were included. Trials indicated favorable weight changes with interventions that were statistically significantly different from control groups in 4 of 5 trials of counseling, but not in 2 trials of exercise. Few harms were reported.
Recommendation
The WPSI recommends counseling midlife women aged 40 to 60 years with normal or overweight BMI (18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity. Counseling may include individualized discussion of healthy eating and physical activity.



Ann Intern Med: 02 Aug 2022; epub ahead of print
Chelmow D, Gregory KD, Witkop C, Hoffstetter S, ... Zahn C, Women's Preventive Services Initiative*
Ann Intern Med: 02 Aug 2022; epub ahead of print | PMID: 35914264
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Ethical Considerations in Precision Medicine and Genetic Testing in Internal Medicine Practice: A Position Paper From the American College of Physicians.

Lehmann LS, Sulmasy LS, Burke W, ACP Ethics, Professionalism and Human Rights Committee*
This American College of Physicians position paper aims to inform ethical decision making for the integration of precision medicine and genetic testing into clinical care. Although the positions are primarily intended for practicing physicians, they may apply to other health care professionals and can also inform how health care systems, professional schools, and residency programs integrate genomics into educational and clinical settings. Addressing the challenges of precision medicine and genetic testing will guide ethical and responsible implementation to improve health outcomes.



Ann Intern Med: 26 Jul 2022; epub ahead of print
Lehmann LS, Sulmasy LS, Burke W, ACP Ethics, Professionalism and Human Rights Committee*
Ann Intern Med: 26 Jul 2022; epub ahead of print | PMID: 35878403
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Associations of Atrial Fibrillation After Noncardiac Surgery With Stroke, Subsequent Arrhythmia, and Death : A Cohort Study.

Siontis KC, Gersh BJ, Weston SA, Jiang R, ... Noseworthy PA, Chamberlain AM
Background
Postoperative atrial fibrillation (AF) after noncardiac surgery confers increased risks for ischemic stroke and transient ischemic attack (TIA). How outcomes for postoperative AF after noncardiac surgery compare with those for AF occurring outside of the operative setting is unknown.
Objective
To compare the risks for ischemic stroke or TIA and other outcomes in patients with postoperative AF versus those with incident AF not associated with surgery.
Design
Cohort study.
Setting
Olmsted County, Minnesota.
Participants
Patients with incident AF between 2000 and 2013.
Measurements
Patients were categorized as having AF occurring within 30 days of a noncardiac surgery (postoperative AF) or having AF unrelated to surgery (nonoperative AF).
Results
Of 4231 patients with incident AF, 550 (13%) had postoperative AF as their first-ever documented AF presentation. Over a mean follow-up of 6.3 years, 486 patients had an ischemic stroke or TIA and 2462 had subsequent AF; a total of 2565 deaths occurred. The risk for stroke or TIA was similar between those with postoperative AF and nonoperative AF (absolute risk difference [ARD] at 5 years, 0.1% [95% CI, -2.9% to 3.1%]; hazard ratio [HR], 1.01 [CI, 0.77 to 1.32]). A lower risk for subsequent AF was seen for patients with postoperative AF (ARD at 5 years, -13.4% [CI, -17.8% to -9.0%]; HR, 0.68 [CI, 0.60 to 0.77]). Finally, no difference was seen for cardiovascular death or all-cause death between patients with postoperative AF and nonoperative AF.
Limitation
The population consisted predominantly of White patients; caution should be used when extrapolating the results to more racially diverse populations.
Conclusion
Postoperative AF after noncardiac surgery is associated with similar risk for thromboembolism compared with nonoperative AF. Our findings have potentially important implications for the early postsurgical and subsequent management of postoperative AF.
Primary funding source
National Institute on Aging.



Ann Intern Med: 26 Jul 2022; epub ahead of print
Siontis KC, Gersh BJ, Weston SA, Jiang R, ... Noseworthy PA, Chamberlain AM
Ann Intern Med: 26 Jul 2022; epub ahead of print | PMID: 35878404
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Telehealth Strategies for the Delivery of Maternal Health Care : A Rapid Review.

Cantor AG, Jungbauer RM, Totten AM, Tilden EL, ... Hermesch AC, McDonagh MS
Background
Telehealth strategies to supplement or replace in-person maternity care may affect maternal health outcomes.
Purpose
To conduct a rapid review of the effectiveness and harms of telehealth strategies for maternal health care given the recent expansion of telehealth arising from the COVID-19 pandemic, and to produce an evidence map.
Data sources
Systematic searches of MEDLINE, the Cochrane Library, CINAHL, Embase, and Scopus for English-language studies (January 2015 to April 2022).
Study selection
Randomized controlled trials (RCTs) and observational studies of maternal care telehealth strategies versus usual care.
Data extraction
Dual data extraction and risk-of-bias assessment of studies, with disagreements resolved through consensus.
Data synthesis
28 RCTs and 14 observational studies (n = 44 894) were included. Maternal telehealth interventions supplemented in-person care for most studies of mental health and diabetes during pregnancy, primarily resulting in similar, and sometimes better, clinical and patient-reported outcomes versus usual care. Supplementing in-person mental health care with phone- or web-based platforms or mobile applications resulted in similar or better mental health outcomes versus in-person care. A reduced-visit prenatal care schedule using telehealth to replace in-person general maternity care for low-risk pregnancies resulted in similar clinical outcomes and higher patient satisfaction versus usual care. Overall, telehealth strategies were heterogeneous and resulted in similar obstetric and patient satisfaction outcomes. Few studies addressed disparities, health equity, or harms.
Limitations
Interventions varied, and evidence was inadequate for some clinical outcomes.
Conclusion
Replacing or supplementing in-person maternal care with telehealth generally results in similar, and sometimes better, clinical outcomes and patient satisfaction compared with in-person care. The effect on access to care, health equity, and harms is unclear.
Primary funding source
Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42021276347).



Ann Intern Med: 26 Jul 2022; epub ahead of print
Cantor AG, Jungbauer RM, Totten AM, Tilden EL, ... Hermesch AC, McDonagh MS
Ann Intern Med: 26 Jul 2022; epub ahead of print | PMID: 35878405
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Comparing Racial Differences in Emphysema Prevalence Among Adults With Normal Spirometry: A Secondary Data Analysis of the CARDIA Lung Study.

Liu GY, Khan SS, Colangelo LA, Meza D, ... Carnethon MR, Kalhan R
Background
Computed tomography (CT) imaging complements spirometry and may provide insight into racial disparities in respiratory health.
Objective
To determine the difference in emphysema prevalence between Black and White adults with different measures of normal spirometry results.
Design
Observational study using clinical data and spirometry from the CARDIA (Coronary Artery Risk Development in Young Adults) study obtained in 2015 to 2016 and CT scans done in 2010 to 2011.
Setting
4 U.S. centers.
Participants
Population-based sample of Black and White adults.
Measurements
Self-identified race and visually identified emphysema on CT in participants with different measures of \"normal\" spirometry results, calculated using standard race-specific and race-neutral reference equations.
Results
A total of 2674 participants (485 Black men, 762 Black women, 659 White men, and 768 White women) had both a CT scan and spirometry available for analysis. Among participants with a race-specific FEV1 between 80% and 99% of predicted, 6.5% had emphysema. In this group, emphysema prevalence was 3.9-fold (95% CI, 2.1- to 7.1-fold; 15.5% vs. 4.0%) higher among Black men than White men and 1.9-fold (CI, 1.0- to 3.8-fold; 6.6% vs. 3.4%) higher among Black women than White women. Among participants with a race-specific FEV1 between 100% and 120% of predicted, 4.0% had emphysema. In this category, Black men had a 6.4-fold (CI, 2.2- to 18.7-fold; 13.9% vs. 2.2%) higher prevalence of emphysema than White men, whereas Black and White women had a similar prevalence of emphysema (2.6% and 2.0%, respectively). The use of race-neutral equations to identify participants with an FEV1 percent predicted between 80% and 120% attenuated racial differences in emphysema prevalence among men and eliminated racial differences among women.
Limitation
No CT scans were obtained during the most recent study visit (2015 to 2016) when spirometry was done.
Conclusion
Emphysema is often present before spirometry findings become abnormal, particularly among Black men. Reliance on spirometry alone to differentiate lung health from lung disease may result in the underrecognition of impaired respiratory health and exacerbate racial disparities.
Primary funding source
National Institutes of Health.



Ann Intern Med: 19 Jul 2022; epub ahead of print
Liu GY, Khan SS, Colangelo LA, Meza D, ... Carnethon MR, Kalhan R
Ann Intern Med: 19 Jul 2022; epub ahead of print | PMID: 35849828
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

How the Gender Wage Gap for Primary Care Physicians Differs by Compensation Approach : A Microsimulation Study.

Ganguli I, Mulligan KL, Phillips RL, Basu S
Background
The physician gender wage gap may be due, in part, to productivity-based compensation models that undervalue female practice patterns.
Objective
To determine how primary care physician (PCP) compensation by gender differs when applying existing productivity-based and alternative compensation models.
Design
Microsimulation.
Setting
2016 to 2019 national clinical registry of 1222 primary care practices.
Participants
Male and female PCPs matched on specialty, years since medical school graduation, practice site, and sessions worked.
Measurements
Net annual, full-time-equivalent compensation for male versus female PCPs, under productivity-based fee-for-service, panel size-based capitation without or with risk adjustment, and hybrid payment models. Microsimulation inputs included patient and visit characteristics and overhead expenses.
Results
Among 1435 matched male (n = 881) and female (n = 554) PCPs, female PCP panels included patients who were, on average, younger, had lower diagnosis-based risk scores, were more often female, and were more often uninsured or insured by Medicaid rather than by Medicare. Under productivity-based payment, female PCPs earned a median of $58 829 (interquartile range [IQR], $39 553 to $120 353; 21%) less than male PCPs. This gap was similar under capitation ($58 723 [IQR, $42 141 to $140 192]). It was larger under capitation risk-adjusted for age alone ($74 695 [IQR, $42 884 to $152 423]), for diagnosis-based scores alone ($114 792 [IQR, $49 080 to $215 326] and $89 974 [IQR, $26 175 to $173 760]), and for age-, sex-, and diagnosis-based scores ($83 438 [IQR, $28 927 to $129 414] and $66 195 [IQR, $11 899 to $96 566]). The gap was smaller and nonsignificant under capitation risk-adjusted for age and sex ($36 631 [IQR, $12 743 to $73 898]).
Limitation
Panel attribution based on office visits.
Conclusion
The gender wage gap varied by compensation model, with capitation risk-adjusted for patient age and sex resulting in a smaller gap. Future models might better align with primary care effort and outcomes.
Primary funding source
None.



Ann Intern Med: 19 Jul 2022; epub ahead of print
Ganguli I, Mulligan KL, Phillips RL, Basu S
Ann Intern Med: 19 Jul 2022; epub ahead of print | PMID: 35849829
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Long-Term Services and Supports for Older Adults: A Position Paper From the American College of Physicians.

Crowley R, Atiq O, Hilden D, Health and Public Policy Committee of the American College of Physicians*
The number of Americans aged 65 years or older is expected to increase in the coming decades. Because the risk for disability increases with age, more persons will need long-term services and supports (LTSS) to help with bathing, eating, dressing, and other everyday tasks. Long-term services and supports are delivered in nursing homes, assisted living facilities, the person\'s home, and other settings. However, the LTSS sector faces several challenges, including keeping patients and staff safe during the COVID-19 pandemic, workforce shortages, quality problems, and fragmented coverage options. In this position paper, the American College of Physicians offers policy recommendations on LTSS coverage, financing, workforce, safety and quality, and emergency preparedness and calls on policymakers and other stakeholders to reform and improve the LTSS sector so that care is high quality, accessible, equitable, and affordable.



Ann Intern Med: 12 Jul 2022; epub ahead of print
Crowley R, Atiq O, Hilden D, Health and Public Policy Committee of the American College of Physicians*
Ann Intern Med: 12 Jul 2022; epub ahead of print | PMID: 35816710
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Impact of Hepatitis C Treatment Uptake on Cirrhosis and Mortality in Persons Who Inject Drugs : A Longitudinal, Community-Based Cohort Study.

Cepeda JA, Thomas DL, Astemborski J, Rudolph JE, ... Kirk GD, Mehta SH
Background
Hepatitis C virus (HCV) infection can be cured, and the United States has joined the World Health Organization in calling for HCV elimination by 2030. However, historically low uptake of HCV treatment among people who inject drugs (PWID) threatens HCV elimination and exacerbates social and racial health disparities.
Objective
To assess whether all-oral HCV treatments were accessed by PWID and reduced liver disease burden and mortality.
Design
Community-based, longitudinal cohort study of persons with a history of injection drug use.
Setting
Baltimore, Maryland.
Participants
1323 participants enrolled in the ALIVE (AIDS Linked to the IntraVenous Experience) study from 2006 to 2019 and chronically infected with HCV.
Measurements
Liver stiffness measures (LSMs) by transient elastography, HCV RNA, and mortality from the National Death Index.
Results
Among 1323 persons with evidence of chronic HCV infection at baseline, the median age was 49 years. Most were Black (82%), male (71%), and HIV-negative (66%). The proportion in whom HCV RNA was detected decreased from 100% (by definition) in 2006 to 48% in 2019. Across 10 350 valid LSMs, cirrhosis was detected in 15% of participants in 2006, 19% in 2015, and 8% in 2019. Undetectable HCV RNA was significantly associated with reduced odds of cirrhosis (adjusted odds ratio, 0.28 [95% CI, 0.17 to 0.45]) and reduced all-cause mortality risk (adjusted hazard ratio, 0.54 [CI, 0.38 to 0.77]).
Limitation
Noninvasive markers of liver fibrosis have not been validated in persons with sustained virologic response.
Conclusion
Many community-based PWID in Baltimore are receiving HCV treatment, which is associated with sharp decreases in liver disease and mortality. Additional efforts will be needed to reduce residual barriers to treatment and to eliminate HCV as a public health threat for PWID.
Primary funding source
National Institutes of Health.



Ann Intern Med: 12 Jul 2022; epub ahead of print
Cepeda JA, Thomas DL, Astemborski J, Rudolph JE, ... Kirk GD, Mehta SH
Ann Intern Med: 12 Jul 2022; epub ahead of print | PMID: 35816712
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Bipolar Disorder.

Bauer MS
Bipolar disorder (BD) affects approximately 2% of U.S. adults and is the most costly mental health condition for commercial insurers nationwide. Rates of BD are elevated among persons with depression, anxiety disorders, and substance use disorders-conditions frequently seen by primary care clinicians. In addition, antidepressants can precipitate manic or hypomanic symptoms or rapid cycling in persons with undiagnosed BD. Thus, screening in these high-risk groups is indicated. Effective treatments exist, and many can be safely and effectively administered by primary care clinicians.



Ann Intern Med: 12 Jul 2022; epub ahead of print
Bauer MS
Ann Intern Med: 12 Jul 2022; epub ahead of print | PMID: 35816713
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In COVID-19 acute hypoxemic respiratory failure, awake prone positioning vs. the supine position reduces intubations.

Mehta A, Bansal M, Vallabhajosyula S
Source citation
Li J, Luo J, Pavlov I, et al. Awake prone positioning for non-intubated patients with COVID-19-related acute hypoxaemic respiratory failure: a systematic review and meta-analysis. Lancet Respir Med. 2022;10:573-83. 35305308.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Mehta A, Bansal M, Vallabhajosyula S
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785529
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Antinucleocapsid Antibodies After SARS-CoV-2 Infection in the Blinded Phase of the Randomized, Placebo-Controlled mRNA-1273 COVID-19 Vaccine Efficacy Clinical Trial.

Follmann D, Janes HE, Buhule OD, Zhou H, ... El Sahly HM, Baden LR
Background
Immunoassays for determining past SARS-CoV-2 infection have not been systematically evaluated in vaccinated persons in comparison with unvaccinated persons.
Objective
To evaluate antinucleocapsid antibody (anti-N Ab) seropositivity in mRNA-1273 (Moderna) vaccinees with breakthrough SARS-CoV-2 infection.
Design
Nested substudy of a phase 3 randomized, double-blind, placebo-controlled vaccine efficacy trial. (ClinicalTrials.gov: NCT04470427).
Setting
99 sites in the United States, July 2020 through March 2021.
Participants
Participants were aged 18 years or older, had no known history of SARS-CoV-2 infection, and were at risk for SARS-CoV-2 infection or severe COVID-19. Substudy participants were diagnosed with SARS-CoV-2 infection during the trial\'s blinded phase.
Intervention
2 mRNA-1273 or placebo injections 28 days apart.
Measurements
Nasopharyngeal swabs from days 1 and 29 (vaccination days) and from symptom-prompted illness visits were tested for SARS-CoV-2 via polymerase chain reaction (PCR). Serum samples from days 1, 29, and 57 and the participant decision visit (PDV, when participants were informed of treatment assignment; median day 149) were tested for anti-N Abs by the Elecsys immunoassay.
Results
Among 700 participants with PCR-confirmed COVID-19 illness during the blinded phase of the trial (through March 2021), seroconversion to anti-N Abs (median of 53 days after diagnosis) occurred in 21 of 52 mRNA-1273 vaccinees (40% [95% CI, 27% to 54%]) versus 605 of 648 placebo recipients (93% [CI, 92% to 95%]). Each 1-log increase in SARS-CoV-2 viral copies at diagnosis was associated with 90% higher odds of anti-N Ab seroconversion (odds ratio, 1.90 [CI, 1.59 to 2.28]).
Limitation
The scope was restricted to mRNA-1273 vaccinees and the Elecsys assay, the sample size was small, data on Delta and Omicron infections were lacking, and the analysis did not address a prespecified objective of the trial.
Conclusion
Vaccination status should be considered when interpreting seroprevalence and seropositivity data based solely on anti-N Ab testing. Primary Funding source: National Institute of Allergy and Infectious Diseases of the National Institutes of Health.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Follmann D, Janes HE, Buhule OD, Zhou H, ... El Sahly HM, Baden LR
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785530
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Quantifying Individual-Level Inaccuracy in Glomerular Filtration Rate Estimation : A Cross-Sectional Study.

Shafi T, Zhu X, Lirette ST, Rule AD, ... Guallar E, Butler J
Background
Although the population-level differences between estimated glomerular filtration rate (eGFR) and measured glomerular filtration rate (mGFR) are well recognized, the magnitude and potential clinical implications of individual-level differences are unknown.
Objective
To quantify the magnitude and consequences of the individual-level differences between mGFRs and eGFRs.
Design
Cross-sectional study.
Setting
Four U.S. community-based epidemiologic cohort studies with mGFR.
Patients
3223 participants in 4 studies.
Measurements
The GFRs were measured using urinary iothalamate and plasma iohexol clearance; the eGFR was calculated from serum creatinine concentration alone (eGFRCR) and with cystatin C. All GFR results are presented as mL/min/1.73 m2.
Results
The participants\' mean age was 59 years; 32% were Black, 55% were women, and the mean mGFR was 68. The population-level differences between mGFR and eGFRCR were small; the median difference (mGFR - eGFR) was -0.6 (95% CI, -1.2 to -0.2); however, the individual-level differences were large. At an eGFRCR of 60, 50% of mGFRs ranged from 52 to 67, 80% from 45 to 76, and 95% from 36 to 87. At an eGFRCR of 30, 50% of mGFRs ranged from 27 to 38, 80% from 23 to 44, and 95% from 17 to 54. Substantial disagreement in chronic kidney disease staging by mGFR and eGFRCR was present. Among those with eGFRCR of 45 to 59, 36% had mGFR greater than 60 whereas 20% had mGFR less than 45; among those with eGFRCR of 15 to 29, 30% had mGFR greater than 30 and 5% had mGFR less than 15. The eGFR based on cystatin C did not provide substantial improvement.
Limitation
Single measurement of mGFR and serum markers without short-term replicates.
Conclusion
A substantial individual-level discrepancy exists between the mGFR and the eGFR. Laboratories reporting eGFR should consider including the extent of this uncertainty to avoid misinterpretation of eGFR as an mGFR replacement.
Primary funding source
National Institutes of Health.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Shafi T, Zhu X, Lirette ST, Rule AD, ... Guallar E, Butler J
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785532
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

A Framework for the Development of Living Practice Guidelines in Health Care.

El Mikati IK, Khabsa J, Harb T, Khamis M, ... Akl EA, Living Guidelines Group†
Background
Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence.
Objective
To develop a framework that characterizes the processes of development of living practice guidelines in health care.
Design
First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders.
Setting
International.
Participants
Multidisciplinary group of 51 persons who have experience with guidelines.
Measurements
Not applicable.
Results
A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization\'s adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication.
Limitation
This study does not provide detailed or practical guidance for how the described concepts would be best implemented.
Conclusion
The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines.
Primary funding source
None.



Ann Intern Med: 05 Jul 2022; epub ahead of print
El Mikati IK, Khabsa J, Harb T, Khamis M, ... Akl EA, Living Guidelines Group†
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785533
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

COVID-19 diagnosis, but not vaccination, was linked to increased risk for immune-mediated neurologic events.

Forster D
Source citation
Li X, Raventós B, Roel E, et al. Association between covid-19 vaccination, SARS-CoV-2 infection, and risk of immune mediated neurological events: population based cohort and self-controlled case series analysis. BMJ. 2022;376:e068373. 35296468.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Forster D
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785537
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In former smokers with COPD, HEPA and carbon filter air cleaners improved moderate exacerbations but not QoL.

Steinberg DI
Source citation
Hansel NN, Putcha N, Woo H, et al. Randomized clinical trial of air cleaners to improve indoor air quality and chronic obstructive pulmonary disease health: results of the CLEAN AIR study. Am J Respir Crit Care Med. 2022;205:421-30. 34449285.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Steinberg DI
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785538
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In critically ill patients with COVID-19, antiplatelet therapy did not increase organ support-free days at 21 d.

Athale J, Danner RL
Source citation
REMAP-CAP Writing Committee for the REMAP-CAP Investigators. Effect of antiplatelet therapy on survival and organ support-free days in critically ill patients with COVID-19: a randomized clinical trial. JAMA. 2022;327:1247-59. 35315874.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Athale J, Danner RL
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785539
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

ESCMID recommendations for COVID-19 testing in asymptomatic persons to prevent transmission in health care.

Macdonald L
Source citation
Carrara E, Ong DS, Hussein K, et al. ESCMID guidelines on testing for SARS-CoV-2 in asymptomatic individuals to prevent transmission in the health care setting. Clin Microbiol Infect. 2022;28:672-80. 35124258.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Macdonald L
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785540
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

ACG-CAG provided suggestions for periendoscopic management of anticoagulants and antiplatelets.

Lichtenstein DR, Dharmadhikari ND
Source citation
Abraham NS, Barkun AN, Sauer BG, et al. American College of Gastroenterology-Canadian Association of Gastroenterology clinical practice guideline: management of anticoagulants and antiplatelets during acute gastrointestinal bleeding and the periendoscopic period. Am J Gastroenterol. 2022;117:542-58. 35297395.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Lichtenstein DR, Dharmadhikari ND
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785542
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

Effect of Social Needs Case Management on Hospital Use Among Adult Medicaid Beneficiaries : A Randomized Study.

Brown DM, Hernandez EA, Levin S, De Vaan M, ... Roth A, Brewster AL
Background
Case management programs assisting patients with social needs may improve health and avoid unnecessary health care use, but little is known about their effectiveness.
Objective
This large-scale study assessed the population-level impact of a case management program designed to address patients\' social needs.
Design
Single-site randomized encouragement design with administrative enrollment from an eligible population and intention-to-treat analysis. Study participants were enrolled between August 2017 and December 2018 and followed for 1 year. (ClinicalTrials.gov: NCT04000074).
Setting
Contra Costa County, an economically and culturally diverse community in the San Francisco Bay Area.
Participants
57 972 randomized enrollments of adult Medicaid patients at elevated risk for health care use (top 15%) to the intervention or control group.
Intervention
Enrollees were offered 12 months of social needs case management, which provided more intensive services to patients with higher demonstrated needs.
Measurements
Medical use was measured via emergency department (ED) visits and inpatient admissions, some of which were classified as avoidable.
Results
Participants in the intervention group visited the ED at ratios of 0.96 (95% CI, 0.91 to 1.00) for all visits and 0.97 (CI, 0.92 to 1.03) for avoidable visits relative to the control group. The intervention group was hospitalized at ratios of 0.89 (CI, 0.81 to 0.98) for all admissions and 0.72 (CI, 0.55 to 0.88) for avoidable admissions.
Limitations
Only 40% of the intervention group engaged with the program. The program was in continual development during the trial period.
Conclusion
Although social needs case management programs may reduce health care use, these savings may not cover full program costs. More work is needed to identify ways to increase patient uptake and define characteristics of successful programs.
Primary funding source
Contra Costa Health Services via the Medicaid waiver program.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Brown DM, Hernandez EA, Levin S, De Vaan M, ... Roth A, Brewster AL
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785543
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:
Abstract

In AF, CV benefits of catheter ablation vs. medical therapy may vary by age.

Almhri A, Leong DP
Source citation
Bahnson TD, Giczewska A, Mark DB, et al. Association between age and outcomes of catheter ablation versus medical therapy for atrial fibrillation: results from the CABANA trial. Circulation. 2022;145:796-804. 34933570.



Ann Intern Med: 05 Jul 2022; epub ahead of print
Almhri A, Leong DP
Ann Intern Med: 05 Jul 2022; epub ahead of print | PMID: 35785544
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.