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Gastroesophageal reflux disease (GERD) is a common medical condition presenting with heartburn, regurgitation, cough, hoarseness, and/or wheezing. Patients with classic GERD symptoms often do not require diagnostic studies before empirical treatment is initiated. However, if atypical features are present, including alarm symptoms for malignancy, or if symptoms do not respond to conventional treatment, upper endoscopy may be necessary. The optimal management of GERD, which is the subject of debate, depends on the frequency and severity of symptoms. In 2021, the American College of Gastroenterology published updated recommendations for diagnosis and management of GERD. In addition to histamine-2 receptor antagonist or proton-pump inhibitor therapy, which may be prescribed as needed or continuously, lifestyle and dietary modification are often advised. Here, 2 physicians, a primary care practitioner and a gastroenterologist, debate how to manage a patient with GERD symptoms. They discuss the diagnosis of this condition, its initial management, indications for upper endoscopy, and how to care for the patient whose condition does not respond to empirical therapy.

High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302)

Background: The mRNA platform is under investigation for many vaccines, including HIV-1 vaccines. Objective: To evaluate the safety and tolerability of 3 investigational HIV-1 trimer mRNA vaccines. Design: Safety analysis of mRNA vaccination in a phase 1, randomized, open-label trial. (ClinicalTrials.gov: NCT05217641) Setting: Ten research sites in the United States. Participants: 108 volunteers aged 18 to 55 years without HIV-1. Intervention: Investigational HIV-1 BG505 MD39.3 trimer mRNA vaccines (gp140 soluble trimer, gp151 membrane-bound trimer, and gp151 CD4KO membrane-bound trimer) at doses of 100 and 250 mcg at 0, 2, and 6 months. Measurements: Solicited and unsolicited adverse reactions and events reported during the 12 months after the first vaccination. Results: Participants (n = 108) were randomly assigned to 6 vaccine groups. Mild to moderate local and systemic solicited events were common. Eighty participants reported 190 unsolicited adverse events (AEs); 30 were considered to be related to a study product. Most (73%) related AEs were mild, and the rest were moderate. Among related AEs, urticaria was reported by 7 of 108 participants (7% [95% CI, 3% to 13%]), 4 of whom had unresolved, intermittent urticaria at 12 months. In post hoc analyses, demographic characteristics, history of allergy or medication use, and COVID-19 were not associated with urticaria. In a comparison of participants with versus without urticaria, 100% (7 of 7; CI, 65% to 100%) versus 37% (37 of 101; CI, 28% to 46%) reported previous Moderna COVID-19 vaccination, 29% (2 of 7; CI, 8% to 64%) versus 76% (77 of 101; CI, 67% to 84%) reported previous Pfizer–BioNTech COVID-19 vaccination, and 0% (0 of 7; CI, 0% to 35%) versus 5% (5 of 101; CI, 2% to 11%) reported no previous mRNA COVID-19 vaccination. Limitations: Lack of a placebo group, open-label study, and post hoc evaluation of urticarial risk. Conclusion: Urticarial reactions associated with experimental HIV-1 mRNA vaccines were observed in this trial. Studies to investigate the mechanism and approaches to mitigate these reactions are underway to further advance HIV-1 vaccine research. Primary Funding Source: National Institutes of Health, National Institute of Allergy and Infectious Diseases.

Improvements in Cardiometabolic Risk Factors by Weight Reduction: A Post Hoc Analysis of Adults With Obesity Randomly Assigned to Tirzepatide

Background: Tirzepatide reduced weight and improved cardiometabolic risk factors for participants in the SURMOUNT-1 trial. The changes in cardiometabolic risk factors by degree of tirzepatide-induced weight reduction across a wide spectrum of weight loss have not been reported. Objective: To determine changes in cardiometabolic risk factors by weight reduction. Design: Post hoc analysis of the phase 3, randomized, double-blind, SURMOUNT-1 trial (ClinicalTrials.gov: NCT04184622). Setting: 119 sites in 9 countries. Participants: Adults (n = 1605) with obesity, or overweight with weight-related complications (excluding diabetes), randomly assigned to tirzepatide treatment groups. Intervention: Once-weekly tirzepatide, 5, 10, or 15 mg. Measurements: Changes from baseline to week 72 in cardiometabolic risk factors by weight reduction. Results: Participants had a mean age of 45.4 years (SD, 12.2) and mean body mass index of 37.9 kg/m2 (SD, 6.7), and 68% were female. The greater weight reduction categories had higher percentages of female and White participants. Participants who lost at least 35% of their body weight from baseline to week 72 had mean changes of up to −14.2 mm Hg (95% CI, −16.1 to −12.3 mm Hg) for systolic blood pressure, −9.2 mm Hg (CI, −10.6 to −7.8 mm Hg) for diastolic blood pressure, −32.4 cm (CI, −33.5 to −31.3 cm) for waist circumference, −59.7% (CI, −63.6% to −55.3%) for the homeostatic model assessment of insulin resistance (HOMA-IR), and −0.65 percentage point (CI, −0.70 to −0.61 percentage point) for hemoglobin A1c. The relationship between percentage weight reduction and changes in cardiometabolic risk factors seemed mostly linear for waist circumference and blood pressure, with a steeper slope for systolic than diastolic blood pressure. Decreases in HOMA-IR and hemoglobin A1c were observed even with modest weight reduction, with the steepest effect occurring between less than 5% and less than 20% weight reduction. Improvements in levels of triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein cholesterol, and non-HDL cholesterol were primarily observed only after weight reductions greater than 10%. Results were consistent after adjustment for baseline differences. Limitations: The analysis was post hoc and should be regarded as hypothesis-generating. Duration and sample size precluded evaluation of cardiovascular outcomes. Conclusion: In SURMOUNT-1, tirzepatide-associated improvements in cardiometabolic risk factors positively related to the degree of weight reduction, but the pattern varied depending on outcome measure. Primary Funding Source: Eli Lilly and Company.

Guidelines International Network: Principles for Use of Artificial Intelligence in the Health Guideline Enterprise

Description: Artificial intelligence (AI) has been defined by the High-Level Expert Group on AI of the European Commission as “systems that display intelligent behaviour by analysing their environment and taking actions—with some degree of autonomy—to achieve specific goals.” Artificial intelligence has the potential to support guideline planning, development and adaptation, reporting, implementation, impact evaluation, certification, and appraisal of recommendations, which we will refer to as “guideline enterprise.” Considering this potential, as well as the lack of guidance for the use of AI in guidelines, the Guidelines International Network (GIN) proposes a set of principles for the development and use of AI tools or processes to support the health guideline enterprise. Methods: A GIN working group on AI developed these principles, informed by the results of a scoping review and practical examples, through iterative discussion. Recommendations: Eight principles were identified to adhere to when using AI in the guideline context: transparency, preplanning, additionality, credibility, ethics, accountability, compliance, and evaluation. These complementary principles are described in a comprehensive way, but they do not provide detailed instructions on how to use specific AI tools. Although these principles are expected to apply across different contexts and stages of the guideline enterprise, details on their implementation have some degree of flexibility. Guideline development groups choosing to use AI will be able to adequately implement the principles if they ensure aspects such as structured reporting on the use of AI tools, involvement of experts in AI, and allocation of funding for the adequate use of AI tools. The GIN principles may support guideline developers in the responsible and transparent use of AI to ensure trustworthy guidelines.

Incorporating Economic Evidence in Clinical Guidelines: A Framework From the Clinical Guidelines Committee of the American College of Physicians

In recognition of accelerating health care spending and alignment with the American College of Physicians (ACP) principles of promoting high-value care, the ACP Clinical Guidelines Committee (CGC) developed a framework to standardize its approach to identifying, appraising, and considering economic evidence in the development of ACP clinical guidelines. This article presents the CGC’s process for incorporating economic evidence, which encompasses cost-effectiveness analyses, economic outcomes in randomized controlled trials, and resource utilization (intervention cost) data. Economic evidence is one component of ACP recommendations. The CGC first and foremost assesses the certainty of evidence for clinical net benefit of interventions; it then considers patient values and preferences, and only then considers economic evidence to develop recommendations.

How Would You Manage This Patient With Obesity? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

In 2022, 1 in 8 people in the world were living with obesity, and lifestyle interventions that include diet, exercise, and behavioral modification have been the foundation for management of obesity. Recently, pharmacologic therapies have been developed for management of obesity, the newest of these being glucagon-like peptide 1 receptor agonists. With the development of new pharmacologic options, the American Gastroenterological Association developed a guideline in 2022 to provide evidence-based recommendations for the pharmacologic management of obesity in adults and recommended, for adults with obesity or overweight with weight-related complications who have had an inadequate response to lifestyle interventions, adding pharmacologic agents to lifestyle interventions over continuing lifestyle interventions alone. In this article, 2 experts review the available evidence to answer the following questions: How effective are lifestyle interventions for the treatment of obesity? How effective are pharmacologic interventions for the treatment of obesity? Given these options, how do you engage in a shared decision-making discussion to develop a mutually agreed-on treatment plan?

Evaluation of a Region-Wide Hospital-Based Violence Intervention Program: A Pilot Cohort Study: Annals of Internal Medicine: Vol 178, No 8

Background: Violent injury survivors are at risk for revictimization. The St. Louis area hospital-based violence intervention program (HVIP), Life Outside of Violence (LOV), is the first multisystem, region-wide HVIP in the United States. Objective: To describe the LOV program during its pilot phase and evaluate violent reinjury 1 year after index injury among LOV participants. Design: Pilot observational cohort study of violently injured patients. Setting: Data were queried from the program’s multisystem data repository, which contains individual encounter-level data for all violent injury visits from the 2 adult and 2 pediatric LOV-partner level 1 trauma hospitals. Participants: Patients eligible for LOV who were violently injured between 15 August 2018 and 31 December 2022 and enrolled in LOV, matched to control participants of nonenrolled LOV-eligible patients selected from the data repository using propensity score matching. Intervention: Participation in the LOV program. Measurements: Sociodemographic characteristics, predictors of LOV enrollment, and returning to a LOV partner hospital with a violent reinjury within 1 year of index injury. The probability of violent reinjury and 95% CIs were compared between LOV participants and control participants using Kaplan–Meier estimates. Results: 233 of 3744 eligible patients enrolled in LOV. Of 198 LOV-enrolled participants matched to 388 nonenrolled control participants, Kaplan–Meier estimates for 1-year probability of reinjury were 7.6% (95% CI, 3.8% to 11.2%) among LOV participants and 7.4% (CI, 4.8% to 10.0%) in control participants. Limitation: This pilot study cannot provide precise estimates of LOV intervention efficacy. Conclusion: Although no informative evidence of differences in reinjury probability for LOV participants was seen, findings suggest that the overwhelming risk in which our patients are immersed cannot be overcome by an approach scaled for individual-level impact. Primary Funding Source: Missouri Foundation for Health.

Effectiveness of Synchronous Postdischarge Contacts on Health Care Use and Patient Satisfaction: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 178, No 2

Background: Postdischarge contacts (PDCs) after hospitalization are common practice, but their effectiveness in reducing use of acute care after discharge remains unclear. Purpose: To assess the effects of PDC on 30-day emergency department (ED) visits, 30-day hospital readmissions, and patient satisfaction. Data Sources: MEDLINE, Embase, and CINAHL searched from 2012 to 25 May 2023. Study Selection: Randomized and nonrandomized trials of PDC within 7 days. Data Extraction: Two investigators independently screened articles and assessed risk of bias (ROB). Single reviewers extracted data, with verification by second investigators. Random-effects meta-analyses were done on outcomes shared by at least 3 studies, and the certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. Data Synthesis: Of 13 included studies (11 randomized trials [RTs]), 12 delivered PDCs via telephone. Three of 11 RTs were rated as having low ROB, with 1 rated high. Most PDC interventions (n = 10) consisted of single telephone contacts, often within 3 days. Eight studies focused on patients identified as higher-risk by the authors. There were no differences in 30-day ED use (5 RTs; 3054 patients; risk difference, 0.00 [95% CI, −0.02 to 0.03]; moderate certainty) or 30-day hospital readmissions (7 RTs; 7075 patients; risk difference, 0.00 [CI, −0.02 to 0.02]; moderate certainty) with PDC. Limitation: Adherence and fidelity to PDC interventions were poorly described, and only 1 study investigated nontelephone PDC. Conclusion: Postdischarge contacts within 7 days of discharge were not associated with reductions in 30-day ED use or readmissions compared with usual care. Health systems should reconsider the utility of universal PDCs because multifaceted interventions targeting higher-risk patients may be necessary to reduce use of acute care after discharge. Primary Funding Source: Department of Veterans Affairs. (PROSPERO: CRD42023465675)

Potential Clinical and Economic Impacts of Cutbacks in the President’s Emergency Plan for AIDS Relief Program in South Africa: A Modeling Analysis: Annals of Internal Medicine: Vol 178, No 4

Background: Future U.S. congressional funding for the President’s Emergency Plan for AIDS Relief (PEPFAR) program is uncertain. Objective: To evaluate the clinical and economic impacts of abruptly scaling back PEPFAR funding ($460 million) from South Africa’s total HIV budget ($2.56 billion) in 2024. Design: Model-based analysis of 100%, 50%, and 0% PEPFAR funding with proportional decreases in HIV diagnosis rates (26.0, 24.3, 22.6 per 100 person-years [PY]), 1-year treatment engagement (people with HIV [PWH] receiving/initiating antiretroviral therapy: 92.2%/80.4%, 87.1%/76.0%, 82.0%/71.5%), and primary prevention (4.0%, 2.2%, 0.5% reduction in incidence with no programming [1.24 per 100 PY]). Data Sources: Published HIV care continuum; PEPFAR funding estimates. Target Population: South African adults (HIV prevalence, 16.2%; incidence, 0.32 per 100 PY). Time Horizon: Lifetime. Perspective: Health care sector. Intervention: PEPFAR funded 100% (PEPFAR_100%), 50% (PEPFAR_50%), or 0% (PEPFAR_0%). Outcome Measures: HIV infections, life expectancy, and lifetime costs (2023 U.S. dollars). Results of Base-Case Analysis: With current HIV programming (PEPFAR_100%), 1 190 000 new infections are projected over 10 years; life expectancy would be 61.42 years for PWH, with lifetime costs of $11 180 per PWH. Reduced PEPFAR funding (PEPFAR_50% and PEPFAR_0%) would add 286 000 and 565 000 new infections, respectively. PWH would lose 2.02 and 3.71 life-years with nominal lifetime cost reductions of $620 per PWH and $1140 per PWH that would be offset at the population level by more PWH requiring treatment for infection. Results of Sensitivity Analysis: Countries with similar HIV prevalence and greater reliance on PEPFAR funding could experience disproportionately higher incremental infections and survival losses. Limitation: Budget fungibility and exact programmatic implications of reducing PEPFAR funding are unknown. Conclusion: Abrupt PEPFAR cutbacks would have immediate and long-term detrimental effects on epidemiologic and clinical HIV outcomes in South Africa. Primary Funding Source: National Institutes of Health.

How Would You Treat This Inpatient With Type 2 Diabetes Mellitus? Grand Rounds Discussion From Beth Israel Deaconess Medical Center

Management of hospitalized patients with type 2 diabetes mellitus (T2DM) presents unique challenges. Two recently released guidelines, one from the American Diabetes Association and the other from the Endocrine Society, provide useful recommendations and evidence review to inform the care of medical inpatients with T2DM. These guidelines mostly agree, although there are slight differences in their recommendations. In these rounds, 2 expert diabetologists discuss their approach to inpatient management of T2DM, specifically regarding inpatient glycemic goals on the medical ward, the use of noninsulin antihyperglycemic medications, and patient safety strategies for patients receiving long-acting insulin. They conclude with recommendations for Mr. D, a real patient with T2DM admitted with a recurrent foot infection.

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