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Background: Half of Americans have at least 1 chronic disease. Many in this group, particularly racial/ethnic minorities, lacked insurance coverage and access to care before the Patient Protection and Affordable Care Act (ACA) was enacted. Objective: To determine whether the ACA has had an effect on insurance coverage, access to care, and racial/ethnic disparities among adults with chronic disease. Design: Quasi-experimental policy intervention. Setting: Nationally representative, noninstitutionalized sample in the United States. Patients: 606 277 adults aged 18 to 64 years with a chronic disease. Intervention: Implementation of ACA provisions on 1 January 2014. Measurements: Self-reported insurance coverage, having a checkup, having a personal physician, and not having to forgo a needed physician visit because of cost. Results: After the ACA was implemented, insurance coverage increased by 4.9 percentage points (95% CI, 4.4 to 5.4), not having to forgo a physician visit increased by 2.4 percentage points (CI, 1.9 to 2.9), and having a checkup increased by 2.7 percentage points (CI, 2.2 to 3.4). Having a personal physician did not change (0.3 percentage points [CI, −0.2 to 0.8]). All outcomes varied considerably by state, and coverage increased more in states that expanded Medicaid. Although racial/ethnic minorities had greater improvements in some outcomes, approximately 1 in 5 black and 1 in 3 Hispanic persons with a chronic disease continued to lack coverage and access to care after ACA implementation. Limitation: The study examined data from only the first year of the ACA's major coverage expansion provisions. Conclusion: Although the ACA increased coverage and access for persons with chronic disease, substantial gaps remain, particularly for minorities and those in Medicaid nonexpansion states. Primary Funding Source: None.

GRADE Methods for Guideline Development: Time to Evolve?

Treatment With Ledipasvir–Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial: Annals of Internal Medicine: Vol 166, No 2

Background: Use of interferon and ribavirin to treat chronic hepatitis C virus (HCV) infection in kidney transplant recipients is limited because of the risk for allograft rejection and poor tolerability. Objective: To evaluate the safety and efficacy of the interferon- and ribavirin-free regimen ledipasvir–sofosbuvir in kidney transplant recipients with chronic genotype 1 or 4 HCV infection. Design: Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT02251717) Setting: 5 sites in Europe. Patients: Treatment-naive or -experienced kidney transplant recipients with chronic genotype 1 or 4 HCV infection, with or without compensated cirrhosis, and with an estimated glomerular filtration rate (eGFR) of 40 mL/min or greater were randomly assigned 1:1 to receive ledipasvir (90 mg) and sofosbuvir (400 mg) for 12 or 24 weeks. Measurements: The primary end point was sustained virologic response at 12 weeks after therapy ended (SVR12). Results: Among 114 patients, the median age was 53 years, 58% were male, 91% had genotype 1 infection, 69% were treatment naive, and 15% had compensated cirrhosis. The median eGFR was 56 mL/min (range, 35 to 135 mL/min). One hundred percent of patients (57 of 57) treated for 12 weeks (95% CI, 94% to 100%) and 100% of those (57 of 57) treated for 24 weeks (CI, 94% to 100%) achieved SVR12. Serious adverse events were reported in 13 patients (11%). Of these, 3 events—syncope, pulmonary embolism, and serum creatinine increase—in 3 patients were determined to be treatment related. One patient permanently discontinued treatment because of an adverse event (syncope). The most frequent adverse events overall were headache (n = 22 [19%]), asthenia (n = 16 [14%]), and fatigue (n = 11 [10%]). Limitations: The study was open label, no inferential statistics were planned, and only patients with genotype 1 or 4 infection were included. Few patients with HCV genotype 1a and cirrhosis were enrolled. Conclusion: Treatment with ledipasvir–sofosbuvir for 12 or 24 weeks was well-tolerated and seemed to have an acceptable safety profile among kidney transplant recipients with HCV genotype 1 or 4 infection, all of whom achieved SVR12. Primary Funding Source: Gilead Sciences.

Racial and Ethnic Disparities in Interval Colorectal Cancer Incidence: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 166, No 12

Background: Interval colorectal cancer (CRC) accounts for 3% to 8% of all cases of CRC in the United States. Data on interval CRC by race/ethnicity are scant. Objective: To examine whether risk for interval CRC among Medicare patients differs by race/ethnicity and whether this potential variation is accounted for by differences in the quality of colonoscopy, as measured by physicians' polyp detection rate (PDR). Design: Population-based cohort study. Setting: Medicare program. Participants: Patients aged 66 to 75 years who received colonoscopy between 2002 and 2011 and were followed through 2013. Measurements: Kaplan–Meier curves and adjusted Cox models were used to estimate cumulative probabilities and hazard ratios (HRs) of interval CRC, defined as a CRC diagnosis 6 to 59 months after colonoscopy. Results: There were 2735 cases of interval CRC identified over 235 146 person-years of follow-up. A higher proportion of black persons (52.8%) than white persons (46.2%) received colonoscopy from physicians with a lower PDR. This rate was significantly associated with interval CRC risk. The probability of interval CRC by the end of follow-up was 7.1% in black persons and 5.8% in white persons. Compared with white persons, black persons had significantly higher risk for interval CRC (HR, 1.31 [95% CI, 1.13 to 1.51]); the disparity was more pronounced for cancer of the rectum (HR, 1.70 [CI, 1.25 to 2.31]) and distal colon (HR, 1.45 [CI, 1.00 to 2.11]) than for cancer of the proximal colon (HR, 1.17 [CI, 0.96 to 1.42]). Adjustment for PDR did not alter HRs by race/ethnicity, but differences between black persons and white persons were greater among physicians with higher PDRs. Limitation: Colonoscopy and polypectomy were identified by using billing codes. Conclusion: Among elderly Medicare enrollees, the risk for interval CRC was higher in black persons than in white persons; the difference was more pronounced for cancer of the distal colon and rectum and for physicians with higher PDRs. Primary Funding Source: American Cancer Society.

Antibiotic Prescribing for Nonbacterial Acute Upper Respiratory Infections in Elderly Persons

Background: Reducing inappropriate antibiotic prescribing for acute upper respiratory tract infections (AURIs) requires a better understanding of the factors associated with this practice. Objective: To determine the prevalence of antibiotic prescribing for nonbacterial AURIs and whether prescribing rates varied by physician characteristics. Design: Retrospective analysis of linked administrative health care data. Setting: Primary care physician practices in Ontario, Canada (January–December 2012). Patients: Patients aged 66 years or older with nonbacterial AURIs. Patients with cancer or immunosuppressive conditions and residents of long-term care homes were excluded. Measurements: Antibiotic prescriptions for physician-diagnosed AURIs. A multivariable logistic regression model with generalized estimating equations was used to examine whether prescribing rates varied by physician characteristics, accounting for clustering of patients among physicians and adjusting for patient-level covariates. Results: The cohort included 8990 primary care physicians and 185 014 patients who presented with a nonbacterial AURI, including the common cold (53.4%), acute bronchitis (31.3%), acute sinusitis (13.6%), or acute laryngitis (1.6%). Forty-six percent of patients received an antibiotic prescription; most prescriptions were for broad-spectrum agents (69.9% [95% CI, 69.6% to 70.2%]). Patients were more likely to receive prescriptions from mid- and late-career physicians than early-career physicians (rate difference, 5.1 percentage points [CI, 3.9 to 6.4 percentage points] and 4.6 percentage points [CI, 3.3 to 5.8 percentage points], respectively), from physicians trained outside of Canada or the United States (3.6 percentage points [CI, 2.5 to 4.6 percentage points]), and from physicians who saw 25 to 44 patients per day or 45 or more patients per day than those who saw fewer than 25 patients per day (3.1 percentage points [CI, 2.1 to 4.0 percentage points] and 4.1 percentage points [CI, 2.7 to 5.5 percentage points], respectively). Limitation: Physician rationale for prescribing was unknown. Conclusion: In this low-risk elderly cohort, 46% of patients with a nonbacterial AURI were prescribed antibiotics. Patients were more likely to receive prescriptions from mid- or late-career physicians with high patient volumes and from physicians who were trained outside of Canada or the United States. Primary Funding Source: Ontario Ministry of Health and Long-term Care, Academic Medical Organization of Southwestern Ontario, Schulich School of Medicine and Dentistry, Western University, and Lawson Health Research Institute.

Primary Care Physician Volume and Quality of Diabetes Care: A Population-Based Cohort Study: Annals of Internal Medicine: Vol 166, No 4

Background: A relationship between higher patient volume and both better quality of care and better outcomes has been shown for many acute care conditions. Whether a volume–quality relationship exists for the outpatient management of chronic diseases is uncertain. Objective: To explore the association between primary care physician volume and quality of diabetes care. Design: Cohort study. Setting: The study was conducted using linked population-based health care administrative data in Ontario, Canada. Patients: 1 018 647 adults with diabetes in 2011 who received care from 9014 primary care physicians. Two measures of volume were ascertained for each physician: overall ambulatory volume (representing time available to devote to chronic disease management during patient encounters) and diabetes-specific volume (representing disease-specific expertise). Measurements: Quality of care was measured over a 2-year period using 6 indicators: disease monitoring (eye examination, hemoglobin A1c testing, and low-density lipoprotein cholesterol testing), prescribing appropriate medications (angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers and statins), and adverse clinical outcomes (emergency department visits for hypoglycemia or hyperglycemia). Results: Higher overall ambulatory volume was associated with lower rates of appropriate disease monitoring and medication prescription. In contrast, higher diabetes-specific volume was associated with better quality of care across all 6 indicators. Limitation: Only a select set of quality indicators and potential confounders could be ascertained from available data. Conclusion: Primary care physicians with busier ambulatory patient practices delivered lower-quality diabetes care, but those with greater diabetes-specific experience delivered higher-quality care. These findings show that relationships between physician volume and quality can be extended from acute care to outpatient chronic disease care. Health policies or programs to support physicians with a low volume of patients with diabetes may improve care. Primary Funding Source: Canadian Institutes of Health Research.

Should We Offer Medication to Reduce Breast Cancer Risk?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 165, No 3

In November 2013, the U.S. Preventive Services Task Force issued a guideline on medications for risk reduction of primary breast cancer in women. Although mammography can detect early cases, it cannot prevent development of breast cancer. Tamoxifen and raloxifene are selective estrogen receptor modulators that have been shown to reduce the risk for estrogen receptor–positive breast cancer and are approved by the U.S. Food and Drug Administration (FDA) for this indication. However, neither medication reduces the risk for estrogen receptor–negative breast cancer or all-cause mortality. The Task Force concluded that postmenopausal women with an estimated 5-year risk for breast cancer of 3% or greater will probably have more net benefit than harm and recommends that clinicians engage in shared, informed decision making about these medications. The American Society of Clinical Oncology issued a practice guideline on use of pharmacologic interventions for breast cancer in 2013. It recommends that women aged 35 years or older at increased risk, defined as a 5-year absolute risk for breast cancer of 1.66% or greater, discuss breast cancer prevention medications with their primary care practitioner. The Society includes the aromatase inhibitor exemestane in addition to tamoxifen and raloxifene as a breast cancer prevention medication, although exemestane is not FDA approved for this indication. Here, an oncologist and an internist discuss how they would balance these recommendations and what they would suggest for an individual patient.

Should We Treat for Subclinical Hypothyroidism?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 164, No 11

In May 2015, the U.S. Preventive Services Task Force issued a guideline on screening for thyroid disease that included a systematic evidence review and an update of its 2004 recommendations. The review assessed the effect of treating screen-detected subclinical thyroid dysfunction on health outcomes. It found adequate evidence that treating subclinical hypothyroidism does not provide clinically meaningful improvements in blood pressure, body mass index, bone mineral density, lipid levels, or quality-of-life measures. The review also concluded that evidence was inadequate to determine whether screening for thyroid dysfunction reduced cardiovascular disease or related morbidity and mortality. In separate guidelines, the American Association of Clinical Endocrinologists and American Thyroid Association advocated aggressive case-finding and recommended screening persons with certain clinical conditions or characteristics rather than the general population. These societies argue that subclinical hypothyroidism adversely affects cardiovascular outcomes and thus merits case-finding. Here, 2 experts discuss their perspectives on whether treating subclinical hypothyroidism reduces morbidity and mortality, whether there are harms of treatment, and how they would balance the benefits and harms of treatment both in general and for a specific patient.

The Relationship of Obesity to Hospice Use and Expenditures: A Cohort Study: Annals of Internal Medicine: Vol 166, No 6

Background: Obesity complicates medical, nursing, and informal care in severe illness, but its effect on hospice use and Medicare expenditures is unknown. Objective: To describe the associations between body mass index (BMI) and hospice use and Medicare expenditures in the last 6 months of life. Design: Retrospective cohort. Setting: The HRS (Health and Retirement Study). Participants: 5677 community-dwelling Medicare fee-for-service beneficiaries who died between 1998 and 2012. Measurements: Hospice enrollment, days enrolled in hospice, in-home death, and total Medicare expenditures in the 6 months before death. Body mass index was modeled as a continuous variable with a quadratic functional form. Results: For decedents with BMI of 20 kg/m2, the predicted probability of hospice enrollment was 38.3% (95% CI, 36.5% to 40.2%), hospice duration was 42.8 days (CI, 42.3 to 43.2 days), probability of in-home death was 61.3% (CI, 59.4% to 63.2%), and total Medicare expenditures were $42 803 (CI, $41 085 to $44 521). When BMI increased to 30 kg/m2, the predicted probability of hospice enrollment decreased by 6.7 percentage points (CI, −9.3 to −4.0 percentage points), hospice duration decreased by 3.8 days (CI, −4.4 to −3.1 days), probability of in-home death decreased by 3.2 percentage points (CI, −6.0 to −0.4 percentage points), and total Medicare expenditures increased by $3471 (CI, $955 to $5988). For morbidly obese decedents (BMI ≥40 kg/m2), the predicted probability of hospice enrollment decreased by 15.2 percentage points (CI, −19.6 to −10.9 percentage points), hospice duration decreased by 4.3 days (CI, −5.7 to −2.9 days), and in-home death decreased by 6.3 percentage points (CI, −11.2 to −1.5 percentage points) versus decedents with BMI of 20 kg/m2. Limitation: Baseline data were self-reported, and the interval between reported BMI and time of death varied. Conclusion: Among community-dwelling decedents in the HRS, increasing obesity was associated with reduced hospice use and in-home death and higher Medicare expenditures in the last 6 months of life. Primary Funding Source: Robert Wood Johnson Foundation Clinical Scholars Program.

Effect of Temporal Changes in Therapeutic Exposure on Self-reported Health Status in Childhood Cancer Survivors

Background: The effect of temporal changes in cancer therapy on health status among childhood cancer survivors has not been evaluated. Objective: To compare proportions of self-reported adverse health status outcomes among childhood cancer survivors across 3 decades. Design: Cross-sectional. (ClinicalTrials.gov: NCT01120353) Setting: 27 North American institutions. Participants: 14 566 adults, who survived for 5 or more years after initial diagnosis (median age, 27 years; range, 18 to 48 years), treated from 1970 to 1999. Measurements: Patient report of poor general or mental health, functional impairment, activity limitation, or cancer-related anxiety or pain was evaluated as a function of treatment decade, cancer treatment exposure, chronic health conditions, demographic characteristics, and health habits. Results: Despite reductions in late mortality and the proportions of survivors with severe, disabling, or life-threatening chronic health conditions (33.4% among those treated from 1970 to 1979 and 21.0% among those treated from 1990 to 1999), those reporting adverse health status did not decrease by treatment decade. Compared with survivors diagnosed in 1970 to 1979, those diagnosed in 1990 to 1999 were more likely to report poor general health (11.2% vs. 13.7%; P < 0.001) and cancer-related anxiety (13.3% vs. 15.0%; P < 0.001). From 1970 to 1979 and 1990 to 1999, the proportions of survivors reporting adverse outcomes were higher (P < 0.001) among those with leukemia (poor general health, 9.5% and 13.9%) and osteosarcoma (pain, 23.9% and 36.6%). Temporal changes in treatment exposures were not associated with changes in the proportions of survivors reporting adverse health status. Smoking, not meeting physical activity guidelines, and being either underweight or obese were associated with poor health status. Limitation: Considerable improvement in survival among children diagnosed with cancer in the 1990s compared with those diagnosed in the 1970s makes it difficult to definitively determine the effect of risk factors on later self-reported health status without considering their effect on mortality. Conclusion: Because survival rates after a diagnosis of childhood cancer have improved substantially over the past 30 years, the population of survivors now includes those who would have died in earlier decades. Self-reported health status among survivors has not improved despite evolution of treatment designed to reduce toxicities. Primary Funding Source: The National Cancer Institute.

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