Clinical Information Search
Search Results for "depression"
- Online Learning Center (10)
- Policy Library (251)
- Performance Measures (13)
- Annals of Internal Medicine (1698)
- Annals of Internal Medicine: Clinical Cases (75)
- IM Matters (173)
- ACP Hospitalist (267)
- ACP Diabetes Monthly (52)
- ACP Gastroenterology Monthly (61)
Displaying 151 - 160 of 251 in Policy Library
Displaying 151 - 160 of 1698 in Annals of Internal Medicine
These Annals of Internal Medicine results only contain recent articles.
- Visit annals.org to search all content back to 1927.
- View Annals of Internal Medicine CME by topic here.
How Would You Screen This Patient for Colorectal Cancer?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 175, No 10
Colorectal cancer (CRC) is the third leading cause of cancer death for men and women in the United States, with an estimated 52 580 people expected to die in 2022. Most frequently, CRC is diagnosed among persons aged 65 to 74 years. However, among persons younger than 50 years, incidence rates have been increasing since the mid-1990s. In 2021, partially because of the rising incidence, the U.S. Preventive Services Task Force (USPSTF) recommended CRC screening for adults aged 45 to 49 years (Grade B recommendation). Options for CRC screening include stool-based and direct visualization tests. The USPSTF did not recommend a specific screening test; rather, its guidance was to select a test after a discussion with the patient. Here, a primary care physician and a gastroenterologist discuss the recommendation to begin CRC screening at age 45, review options for CRC screening, and discuss how to choose among the available options.
Comparative Effectiveness of Team-Based Care With and Without a Clinical Decision Support System for Diabetes Management: A Cluster Randomized Trial: Annals of Internal Medicine: Vol 176, No 1
Background: Uncontrolled hyperglycemia, hypercholesterolemia, and hypertension are common in persons with diabetes. Objective: To compare the effectiveness of team-based care with and without a clinical decision support system (CDSS) in controlling glycemia, lipids, and blood pressure (BP) among patients with type 2 diabetes. Design: Cluster randomized trial. (ClinicalTrials.gov: NCT02835287) Setting: 38 community health centers in Xiamen, China. Patients: 11 132 persons aged 50 years or older with uncontrolled diabetes and comorbid conditions, 5475 receiving team-based care with a CDSS and 5657 receiving team-based care alone. Intervention: Team-based care was delivered by primary care physicians, health coaches, and diabetes specialists in all centers. In addition, a computerized CDSS, which generated individualized treatment recommendations based on clinical guidelines, was implemented in 19 centers delivering team-based care with a CDSS. Measurements: Coprimary outcomes were mean reductions in hemoglobin A1c (HbA1c) level, low-density lipoprotein cholesterol (LDL-C) level, and systolic BP over 18 months and the proportion of participants with all 3 risk factors controlled at 18 months. Results: During the 18-month intervention, HbA1c levels, LDL-C levels, and systolic BP significantly decreased by −0.9 percentage point (95% CI, −0.9 to −0.8 percentage point), −0.49 mmol/L (CI, −0.53 to −0.45 mmol/L) (−19.0 mg/dL [CI, −20.4 to −17.5 mg/dL]), and −9.1 mm Hg (CI, −9.9 to −8.3 mm Hg), respectively, in team-based care with a CDSS and by −0.6 percentage point (CI, −0.7 to −0.5 percentage point), −0.32 mmol/L (CI, −0.35 to −0.29 mmol/L) (−12.5 mg/dL [CI, −13.6 to −11.3 mg/dL]), and −7.5 mm Hg (CI, −8.4 to −6.6 mm Hg), respectively, in team-based care alone. Net differences were −0.2 percentage point (CI, −0.3 to −0.1 percentage point) for HbA1c level, −0.17 mmol/L (CI, −0.21 to −0.12 mmol/L) (−6.5 mg/dL [CI, −8.3 to −4.6 mg/dL]) for LDL-C level, and −1.5 mm Hg (CI, −2.8 to −0.3 mm Hg) for systolic BP. The proportion of patients with controlled HbA1c, LDL-C, and systolic BP was 16.9% (CI, 15.7% to 18.2%) in team-based care with a CDSS and 13.0% (CI, 11.7% to 14.3%) in team-based care alone. Limitation: There was no usual care control, and clinical outcome assessors were unblinded; the analysis did not account for multiple comparisons. Conclusion: Compared with team-based care alone, team-based care with a CDSS significantly reduced cardiovascular risk factors in patients with diabetes, but the effect was modest. Primary Funding Source: Xiamen Municipal Health Commission.
Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 175, No 10
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.
Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine–Topiramate to Prevent Exposure During Pregnancy
Background: The U.S. Food and Drug Administration approved phentermine–topiramate for obesity in 2012 and required a Risk Evaluation and Mitigation Strategy (REMS) to prevent prenatal exposure. No such requirement was introduced for topiramate. Objective: To evaluate the rate of prenatal exposure, contraceptive use, and pregnancy testing among patients with phentermine–topiramate compared with topiramate or other antiobesity medications (AOMs). Design: Retrospective cohort study. Setting: Nationwide health insurance claims database. Participants: Females aged 12 to 55 years with no infertility diagnosis or sterilization procedure. Patients with other indications for topiramate were excluded to identify a cohort that was likely treated for obesity. Measurements: Patients initiated use of phentermine–topiramate, topiramate, or an AOM (liraglutide, lorcaserin, or bupropion–naltrexone). Pregnancy at treatment initiation, conception during treatment, contraceptive use, and pregnancy testing outcomes were ascertained. Measurable confounders were adjusted for, and extensive sensitivity analyses were done. Results: A total of 156 280 treatment episodes were observed. Adjusted prevalence of pregnancy at treatment initiation was 0.9 versus 1.6 per 1000 episodes (prevalence ratio, 0.54 [95% CI, 0.31 to 0.95]) for phentermine–topiramate versus topiramate. The incidence rate of conception during treatment was 9.1 versus 15.0 per 1000 person-years (rate ratio, 0.61 [CI, 0.40 to 0.91]) for phentermine–topiramate versus topiramate. Both outcomes were similarly lower for phentermine–topiramate compared with AOM. Prenatal exposure was marginally lower in topiramate users compared with AOM users. Approximately 20% of patients in all cohorts had at least 50% of treatment days covered by contraceptives. Few patients had pregnancy tests before treatment (≤5%), but this was more common among phentermine–topiramate users. Limitations: Outcome misclassification; unmeasured confounding due to lack of prescriber data to account for possible clustering and spillover effects. Conclusion: Prenatal exposure seemed to be significantly lower among phentermine–topiramate users under the REMS. Pregnancy testing and contraceptive use appeared to be inadequate for all groups, which deserves attention to prevent the remaining potential exposures. Primary Funding Source: None.
Assessing Heterogeneity of Treatment Effect in Real-World Data
Increasing availability of real-world data (RWD) generated from patient care enables the generation of evidence to inform clinical decisions for subpopulations of patients and perhaps even individuals. There is growing opportunity to identify important heterogeneity of treatment effects (HTE) in these subgroups. Thus, HTE is relevant to all with interest in patients' responses to interventions, including regulators who must make decisions about products when signals of harms arise postapproval and payers who make coverage decisions based on expected net benefit to their beneficiaries. Prior work discussed HTE in randomized studies. Here, we address methodological considerations when investigating HTE in observational studies. We propose 4 primary goals of HTE analyses and the corresponding approaches in the context of RWD: to confirm subgroup effects, to describe the magnitude of HTE, to discover clinically important subgroups, and to predict individual effects. We discuss other possible goals including exploring prognostic score– and propensity score–based treatment effects, and testing the transportability of trial results to populations different from trial participants. Finally, we outline methodological needs for enhancing real-world HTE analysis.
Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 175, No 12
Background: Parkinson disease (PD) is associated with α-synuclein (αS) aggregation within enteric neurons. ENT-01 inhibits the formation of αS aggregates and improved constipation in an open-label study in patients with PD. Objective: To evaluate the safety and efficacy of oral ENT-01 for constipation and neurologic symptoms in patients with PD and constipation. Design: Randomized, placebo-controlled phase 2b study. (ClinicalTrials.gov: NCT03781791) Setting: Outpatient. Patients: 150 patients with PD and constipation. Intervention: ENT-01 or placebo daily for up to 25 days. After baseline assessment of constipation severity, daily dosing was escalated to the prokinetic dose, the maximum dose (250 mg), or the tolerability limit, followed by a washout period. Measurements: The primary efficacy end point was the number of complete spontaneous bowel movements (CSBMs) per week. Neurologic end points included dementia (assessed using the Mini-Mental State Examination [MMSE]) and psychosis (assessed using the Scale for the Assessment of Positive Symptoms adapted for PD [SAPS-PD]). Results: The weekly CSBM rate increased from 0.7 to 3.2 in the ENT-01 group versus 0.7 to 1.2 in the placebo group (P < 0.001). Improvement in secondary end points included SBMs (P = 0.002), stool consistency (P < 0.001), ease of passage (P = 0.006), and laxative use (P = 0.041). In patients with dementia, MMSE scores improved by 3.4 points 6 weeks after treatment in the ENT-01 group (n = 14) versus 2.0 points in the placebo group (n = 14). Among patients with psychosis, SAPS-PD scores improved from 6.5 to 1.7 six weeks after treatment in the ENT-01 group (n = 5) and from 6.3 to 4.4 in the placebo group (n = 6). ENT-01 was well tolerated, with no deaths or drug-related serious adverse events. Adverse events were predominantly gastrointestinal, including nausea (34.4% [ENT-01] vs. 5.3% [placebo]; P < 0.001) and diarrhea (19.4% [ENT-01] vs. 5.3% [placebo]; P = 0.016). Limitation: Longer treatment periods need to be investigated in future studies. Conclusion: ENT-01 was safe and significantly improved constipation. Primary Funding Source: Enterin, Inc.
Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy: A Cohort Study: Annals of Internal Medicine: Vol 175, No 12
Background: Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared with no mAb treatment. Objective: To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19–related hospital admission or emergency department (ED) visit, COVID-19–associated delivery, or mortality. Design: Retrospective, propensity score–matched, cohort study. Setting: UPMC Health System from 30 April 2021 to 21 January 2022. Participants: Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test). Intervention: Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment. Measurements: Drug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19–related hospital admission or ED visit, COVID-19–associated delivery, or mortality. Results: Among 944 pregnant persons (median age [interquartile range (IQR)], 30 years [26 to 33 years]; White (79.5%; n = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]), 552 received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR, 123 to 227), and most persons received sotrovimab (69%; n = 382). Of those with known vaccination status, 392 (62%) were fully vaccinated. Drug-related adverse events were uncommon (n = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19–associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score–matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19–related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, there was no difference in the propensity score–matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%). Limitations: Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients. Conclusion: In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. There was no difference in 28-day COVID-19–associated outcomes and non-COVID-19–related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score–matched cohort. Primary Funding Source: No funding was received for this study.