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Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial: Annals of Internal Medicine: Vol 168, No 12
This article has been corrected. The original version (PDF) is appended to this article as a Supplement. Background: Primary care models that offer comprehensive, accessible care to all patients may provide insufficient resources to meet the needs of patients with complex conditions who have the greatest risk for hospitalization. Objective: To assess whether augmenting usual primary care with team-based intensive management lowers utilization and costs for high-risk patients. Design: Randomized quality improvement trial. (ClinicalTrials.gov: NCT03100526) Setting: 5 U.S. Department of Veterans Affairs (VA) medical centers. Patients: Primary care patients at high risk for hospitalization who had a recent acute care episode. Intervention: Locally tailored intensive management programs providing care coordination, goals assessment, health coaching, medication reconciliation, and home visits through an interdisciplinary team, including a physician or nurse practitioner, a nurse, and psychosocial experts. Measurements: Utilization and costs (including intensive management program expenses) 12 months before and after randomization. Results: 2210 patients were randomly assigned, 1105 to intensive management and 1105 to usual care. Patients had a mean age of 63 years and an average of 7 chronic conditions; 90% were men. Of the patients assigned to intensive management, 487 (44%) received intensive outpatient care (that is, ≥3 encounters in person or by telephone) and 204 (18%) received limited intervention. From the pre- to postrandomization periods, mean inpatient costs decreased more for the intensive management than the usual care group (−$2164 [95% CI, −$7916 to $3587]). Outpatient costs increased more for the intensive management than the usual care group ($2636 [CI, $524 to $4748]), driven by greater use of primary care, home care, telephone care, and telehealth. Mean total costs were similar in the 2 groups before and after randomization. Limitations: Sites took up to several months to contact eligible patients, limiting the time between treatment and outcome assessment. Only VA costs were assessed. Conclusion: High-risk patients with access to an intensive management program received more outpatient care with no increase in total costs. Primary Funding Source: Veterans Health Administration Primary Care Services.
Benefits and Harms of Cranial Electrical Stimulation for Chronic Painful Conditions, Depression, Anxiety, and Insomnia: A Systematic Review: Annals of Internal Medicine: Vol 168, No 6
Background: Cranial electrical stimulation (CES) is increasingly popular as a treatment, yet its clinical benefit is unclear. Purpose: To review evidence about the benefits and harms of CES for adult patients with chronic painful conditions, depression, anxiety, and insomnia. Data Sources: Several databases from inception to 10 October 2017 without language restrictions and references from experts, prior reviews, and manufacturers. Study Selection: Randomized controlled trials of CES versus usual care or sham CES that reported pain, depression, anxiety, or sleep outcomes in any language. Data Extraction: Single-reviewer extraction checked by another; dual independent quality assessment; strength-of-evidence grading by the first author with subsequent group discussion. Data Synthesis: Twenty-eight articles from 26 randomized trials met eligibility criteria. The 2 trials that compared CES with usual care were small, and neither reported a statistically significant benefit in pain or anxiety outcomes for patients with fibromyalgia or anxiety, respectively. Fourteen trials with sham or placebo controls involving patients with painful conditions, such as headache, neuromuscular pain, or musculoskeletal pain, had conflicting results. Four trials done more than 40 years ago and 1 from 2014 provided low-strength evidence of a possible modest benefit compared with sham treatments in patients with anxiety and depression. Trials in patients with insomnia (n = 2), insomnia and anxiety (n = 1), or depression (n = 3) had inconclusive or conflicting results. Low-strength evidence suggested that CES does not cause serious side effects. Limitation: Most trials had small sample sizes and short durations; all had high risk of bias due to inadequate blinding. Conclusion: Evidence is insufficient that CES has clinically important effects on fibromyalgia, headache, neuromusculoskeletal pain, degenerative joint pain, depression, or insomnia; low-strength evidence suggests modest benefit in patients with anxiety and depression. Primary Funding Source: Veterans Affairs Quality Enhancement Research Initiative. (PROSPERO: CRD42016023951)
Synopsis of the 2017 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: Management of Type 2 Diabetes Mellitus
Description: In April 2017, the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) approved a joint clinical practice guideline for the management of type 2 diabetes mellitus. Methods: The VA/DoD Evidence-Based Practice Work Group convened a joint VA/DoD guideline development effort that included a multidisciplinary panel of practicing clinician stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions in collaboration with the ECRI Institute, which systematically searched and evaluated the literature through June 2016, developed an algorithm, and rated recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. Recommendations: This synopsis summarizes key features of the guideline in 7 areas: patient-centered care and shared decision making, glycemic biomarkers, hemoglobin A1c target ranges, individualized treatment plans, outpatient pharmacologic treatment, glucose targets for critically ill patients, and treatment of hospitalized patients.
Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 168, No 7
Background: Chronic pain is common and challenging to treat. Although cognitive behavioral therapy (CBT) is efficacious, its benefit in disadvantaged populations is largely unknown. Objective: To evaluate the efficacy of literacy-adapted and simplified group CBT versus group pain education (EDU) versus usual care. Design: Randomized controlled trial. (ClinicalTrials.gov: NCT01967342) Setting: Community health centers serving low-income patients in Alabama. Patients: Adults (aged 19 to 71 years) with mixed chronic pain. Interventions: CBT and EDU delivered in 10 weekly 90-minute group sessions. Measurements: Self-reported, postintervention pain intensity (primary outcome) and physical function and depression (secondary outcomes). Results: 290 participants were enrolled (70.7% of whom were women, 66.9% minority group members, 72.4% at or below the poverty level, and 35.8% reading below the fifth grade level); 241 (83.1%) participated in posttreatment assessments. Linear mixed models included all randomly assigned participants. Members of the CBT and EDU groups had larger decreases in pain intensity scores between baseline and posttreatment than participants receiving usual care (estimated differences in change scores—CBT: −0.80 [95% CI −1.48 to −0.11]; P = 0.022; EDU: −0.57 [CI, −1.04 to −0.10]; P = 0.018). At 6-month follow-up, treatment gains were not maintained in the CBT group but were still present in the EDU group. With regard to physical function, participants in the CBT and EDU interventions had greater posttreatment improvement than those receiving usual care, and this progress was maintained at 6-month follow-up. Changes in depression (secondary outcome) did not differ between either the CBT or EDU group and the usual care group. Limitations: Participants represented a single health care system. Self-selection bias may have been present. Conclusion: Simplified group CBT and EDU interventions delivered at low-income clinics significantly improved pain and physical function compared with usual care. Primary Funding Source: Patient-Centered Outcomes Research Institute.
Pharmacist-Led Chronic Disease Management: A Systematic Review of Effectiveness and Harms Compared With Usual Care
Background: Increased involvement of pharmacists in patient care may increase access to health care and improve patient outcomes. Purpose: To determine the effectiveness and harms of pharmacist-led chronic disease management for community-dwelling adults. Data Sources: MEDLINE, Cochrane Library, CINAHL, and International Pharmaceutical Abstracts from 1995 through February 2016, and reference lists of systematic reviews and included studies. Study Selection: 65 patient populations in 63 studies conducted in the United States of any design reported outcomes of pharmacist-led chronic disease management versus a comparator for community-dwelling adults in the United States. Studies set in retail pharmacies were excluded. Data Extraction: Data extraction done by a single investigator was confirmed by a second investigator; risk of bias was assessed by 2 investigators; and strength of evidence was determined by consensus. Data Synthesis: Pharmacist-led care was associated with similar numbers of office visits, urgent care or emergency department visits, and hospitalizations (moderate-strength evidence) and medication adherence (low-strength evidence) compared with usual care (typically continuing a prestudy visit schedule). Pharmacist-led care increased the number or dose of medications received and improved study-selected glycemic, blood pressure, and lipid goal attainment (moderate-strength evidence). Mortality and clinical events were similar (low-strength evidence). Evidence on patient satisfaction was mixed and insufficient. The reporting of harms was limited. Limitations: Interventions were heterogeneous. Studies were typically short-term and designed to assess physiologic intermediate outcomes rather than clinical events. Reporting of many clinical outcomes of interest was limited, and often they were not the study-defined primary end points. Conclusion: Pharmacist-led chronic disease management was associated with effects similar to those of usual care for resource utilization and may improve physiologic goal attainment. Further research is needed to determine whether increased medication utilization and goal attainment improve clinical outcomes. Primary Funding Source: Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative.
Efficacy and Safety of Bisphosphonates for Complex Regional Pain Syndrome: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 179, No 2
Background: Clinical guidelines recommend bisphosphonates for complex regional pain syndrome (CRPS) despite limited evidence of efficacy. Purpose: To determine the efficacy and safety of bisphosphonates compared with placebo for CRPS. Data Sources: MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and 3 trial registries from inception to 16 September 2025. Study Selection: Randomized controlled trials enrolling adults with CRPS (type I or II) to bisphosphonate treatment or placebo. Data Extraction: Primary outcomes were pain intensity and adverse events. Data were synthesized with random-effects meta-analyses. Risk of bias and certainty of evidence were assessed using the Cochrane Risk of Bias 2 Tool and GRADE (Grading of Recommendations Assessment, Development and Evaluation). Data Synthesis: Eleven trials (754 participants; CRPS type I, 97%), evaluating alendronate (n = 2), clodronate (n = 1), neridronate (n = 5), pamidronate (n = 1), and zoledronate (n = 2), were included. Bisphosphonates may result in little to no difference in pain intensity in the immediate term (≤4 weeks; 0-to-100 scale; mean difference [MD], −9.1 [95% CI, −19.2 to 1.1]; low certainty). In the short term (>4 weeks to 3 months; primary time point), bisphosphonates may reduce pain intensity (MD, −10.0 [CI, −18.9 to −1.1]; low certainty), and in the medium term (>3 to 6 months), they may result in little to no difference in pain intensity (MD, 8.0 [CI, −15.4 to 31.4]; low certainty). The evidence is very uncertain about the effects of bisphosphonates on pain intensity in the long term (>6 months; MD, −2.5 [CI, −19.6 to 14.6]). Bisphosphonates probably increase risk for adverse events (risk ratio, 1.1 [CI, 1.0 to 1.2]; moderate certainty). Limitations: High heterogeneity and uncertain medium- and long-term effects. Evidence mostly applies to CRPS type I and includes non–U.S.-approved formulations (neridronate, clodronate). Conclusion: Bisphosphonates may reduce CRPS pain intensity in the short term, but treatment is accompanied by adverse events. Future research should resolve uncertainty around which patients with CRPS are most likely to benefit from bisphosphonates. Primary Funding Source: None. (PROSPERO: CRD42024559783)