Linda M. Quinn

Prospective evaluation of an index for predicting the risk of major bleeding in outpatients treated with warfarin

PURPOSE To evaluate the accuracy and clinical utility of the Outpatient Bleeding Risk Index for estimating the probability of major bleeding in outpatients treated with warfarin. The index was previously derived in a retrospective cohort of 556 patients from a different hospital (derivation cohort). SUBJECTS AND METHODS We enrolled 264 outpatients starting warfarin (validation cohort) to validate the index prospectively. All patients were identified upon hospital discharge, and physician estimates of the probability of major bleeding were obtained before discharge in the validation cohort. RESULTS Major bleeding occurred in 87 of 820 outpatients (6.5%/yr). The index included four independent risk factors for major bleeding: age 65 years or greater; history of gastrointestinal bleeding; history of stroke; and one or more of four specific comorbid conditions. In the validation cohort, the index predicted major bleeding: the cumulative incidence at 48 months was 3% in 80 low-risk patients, 12% in 166 intermediate-risk patients, and 53% in 18 high-risk patients (c index, 0.78). The index performed better than physicians, who estimated the probability of major bleeding no better than expected by chance. Of the 18 episodes of major bleeding that occurred in high-risk patients, 17 were potentially preventable. CONCLUSIONS The Outpatient Bleeding Risk Index prospectively classified patients according to risk of major bleeding and performed better than physicians. Major bleeding may be preventable in many high-risk patients by avoidance of over-anticoagulation and nonsteroidal anti-inflammatory agents.

Effects of a Multicomponent Intervention on Functional Outcomes and Process of Care in Hospitalized Older Patients: A Randomized Controlled Trial of Acute Care for Elders (ACE) in a Community Hospital

BACKGROUND: Older persons frequently experience a decline in function following an acute medical illness and hospitalization.

Lumbar Interbody Fusion Using the Brantigan I/f Cage for Posterior Lumbar Interbody Fusion and the Variable Pedicle Screw Placement System: Two-year Results From a Food and Drug Administration Investigational Device Exemption Clinical Trial

STUDY DESIGN A carbon fiber-reinforced polymer cage implant filled with autologous bone was designed to separate the mechanical and biologic functions of posterior lumbar interbody fusion. OBJECTIVES To test the safety and efficacy of the carbon cage with pedicle screw fixation in a 2-year prospective study performed at six centers under a protocol approved by the Food and Drug Administration, and to present the data supporting the Food and Drug Administration approved indications. SUMMARY OF BACKGROUND DATA The success of posterior lumbar interbody fusion has been limited by mechanical and biologic deficiencies of the donor bone. Some failures of pedicle screw fixation may be attributable to the absence of adequate load sharing through the anterior column. Combining an interbody fusion device with pedicle screw fixation may address some limitations of posterior lumbar interbody fusion or pedicle screw fixation in cases that are more complex mechanically. METHODS This clinical study of posterior lumbar interbody fusion with pedicle screw fixation involved a prospective group of 221 patients. RESULTS Fusion success was achieved in 176 (98.9%) of 178 patients. In the management of degenerative disc disease in patients with prior failed discectomy surgery, clinical success was achieved in 79 (86%) of 92 patients, and radiographic bony arthrodesis in 91 (100%) of 91 patients. Disc space height, averaging 7.9 mm before surgery, was increased to 12.3 mm at surgery and maintained at 11.7 mm at 2 years. Fusion success was notdiminished over multiple fusion levels. These results were significantly better than those reported in prior literature. Although significant surgical complications occurred, those attributable to the implant devices occurred less frequently and generally were minor. CONCLUSIONS The Brantigan I/F Cage for posterior lumbar interbody fusion and the Variable Screw Placement System are safe and effective for the management of degenerative disc disease.

Why isn’t warfarin prescribed to patients with nonrheumatic atrial fibrillation?

OBJECTIVE: To determine the opinions of selected physicians in our community about use of warfarin for patients with nonrheumatic atrial fibrillation, and to determine the relation of the physicians’ opinions to their practices.DESIGN: Survey of physicians, using eight hypothetical clinical vignettes to characterize physicians’ opinions about use of warfarin in patients with nonrheumatic atrial fibrillation, according to patient age, risk of bleeding, and risk of stroke.SETTING: Two teaching hospitals and five community-based practices.PARTICIPANTS: Eighty physicians who cared for 189 consecutive patients with nonrheumatic atrial fibrillation.MEASUREMENTS AND MAIN RESULTS: The survey response rate was 73%. Nearly all responding physicians (90%) recommended warfarin for at least one vignette. However, physicians recommended warfarin less often for vignettes depicting 85-year-old patients than for matched vignettes depicting 65-year-old patients (odds ratio [OR] 0.03; 95% confidence interval [CI] 0.01, 0.08), and less often for cases with specified risk factors for bleeding than for matched cases without the risk factors (OR 0.01; 95% CI 0.004, 0.03); warfarin was recommended more often for cases with a recent stroke than for matched cases without this history (OR 8.2; 95% CI 3.6, 18). In practice, warfarin was prescribed more often (p<-.05) by physicians reporting good personal experience and by those who had favorable opinions about its use. However, even physicians with good experience and favorable opinions did not prescribe warfarin to half of their patents for whom warfarin was independently judged appropriate.CONCLUSIONS: Physicians’ opinions frequently opposed warfarin for older patients with nonrheumatic atrial fibrillation, and for those with bleeding risk factors. Physicians’ opinions, as well as other barriers to warfarin therapy, most likely contribute to its infrequent prescription.

Failure to prescribe warfarin to patients with nonrheumatic atrial fibrillation.

OBJECTIVE: To determine how often warfarin was prescribed to patients with nonrheumatic atrial fibrillation in our community in 1992 when randomized trials had demonstrated that warfarin could prevent stroke with little increase in the rate of hemorrhage, and to determine whether warfarin was prescribed less frequently to older patients—the patients at highest risk of stroke but of most concern to physicians in terms of the safety of warfarin.DESIGN: Cross-sectional study. Appropriateness of warfarin was classified for each patient based on the independent judgments of three physicians applying relevant evidence and guidelines.SETTING: Two teaching hospitals and five community-based practices.PATIENTS: Consecutive patients with nonrheumatic atrial fibrillation (n=189).MEASUREMENTS AND MAIN RESULTS: Warfarin was prescribed to 44 (23%) of the 189 patients. Warfarin was judged appropriate in 98 patients (52%), of whom 36 (37%) were prescribed warfarin. Warfarin was prescribed to 11 (14%) of 76 patients aged 75 years or older with hypertension, diabetes mellitus, or past stroke, the group at highest risk of stroke. In a multivariable logistic regression model controlling for appropriateness of warfarin and other patient characteristics, patients aged 75 years or older were less likely than younger patients to be treated with warfarin (odds ratio 0.25; 95% confidence interval 0.10, 0.65).CONCLUSIONS: Warfarin was prescribed infrequently to these patients with nonrheumatic atrial fibrillation, especially the older patients and even the patients for whom warfarin was judged appropriate. These findings indicate a substantialopportunity to prevent stroke.

Do Acute Care for Elders Units Increase Hospital Costs? A Cost Analysis Using the Hospital Perspective

OBJECTIVE: To compare the hospital costs of caring for medical patients on a special unit designed to help older people maintain or achieve independence in self‐care activities with the costs of usual care.

The safety and efficacy of the Isola Spinal Implant System for the surgical treatment of degenerative disc disease. A prospective study.

Study Design This is a prospective study designed in consultation with and approved by the Food and Drug Administration with the purpose of determining the safety and efficacy of the Isola Spinal Implant System for the surgical treatment of patients with degenerative disc disease. Objectives To report the results of the degenerative disc disease group from the Isola Investigational Device Exemption study, which was done to determine whether the Isola Spinal Implant System is a safe and effective treatment. Summary of Background Data The safety and efficacy of transpedicular instrumentation as an adjunct in achieving lumbar spine fusion are still debated. Methods Hospital Investigational Review Board approval of the study protocol was obtained at the 10 participating centers. One hundred twenty patients (49 men and 71 women; average age, 54 years [range, 25–83 years]) were enrolled. Clinical and radiographic follow‐up evaluation was done using protocols established prospectively. Results Of the 120 patients, 12 (10%) had device‐related problems. There were two operative and four device‐related complications after surgery. Six other patients had their implants removed either for local pain (two) or for looseness or breakage (four). Of 118 patients eligible for follow‐up evaluation at 24 months, 107 (91%) were available for study. Fusion was achieved in 97 (91%) patients. Average combined function and pain scores improved by 2.6 points (P < 0.0001). Clinical success, as measured by combining function and pain scores, was achieved in 65% of the patients by the most stringent criteria and 73% by less stringent criteria. Clinical success was significantly higher in patients who had not had previous surgery than in those who had, 77% versus 57% (P = 0.04). Conclusions The present study suggests that the Isola Spinal Implant System can be safely used, is an effective adjunct in the achievement of fusion, and yields an acceptable number of successful clinical outcomes, especially when considering the preponderance of previously operated patients included in this group.

Workers Without Paid Sick Leave Less Likely To Take Time Off For Illness Or Injury Compared To Those With Paid Sick Leave

Paid sick leave is an important employer-provided benefit that helps people obtain health care for themselves and their dependents. But paid sick leave is not universally available to US workers. Little is known about paid sick leave and its relationship to health behaviors. Contrary to public health goals to reduce the spread of illness, our findings indicate that in 2013 both full- and part-time working adults without paid sick leave were more likely than workers with that benefit to attend work when ill. Those without paid sick leave were 3.0 times more likely to forgo medical care for themselves and 1.6 times more likely to forgo medical care for their family compared to working adults with paid sick leave benefits. Moreover, the lowest-income group of workers without paid sick leave were at the highest risk of delaying and forgoing medical care for themselves and their family members. Policy makers should consider the potential public health implications of their decisions when contemplating guaranteed sick leave benefits.

Factors related to recidivism for youthful offenders

Little is known about youth who were previously placed in a detention facility and what factors predict a subsequent recidivism to placement. This study of a two-county juvenile offender population (one urban and one rural) investigates what demographic, educational, mental health, substance dependence, and court-related variables predict recidivism to detention placement. Findings from logistic regression analysis indicate that seven variables significantly predict juvenile offenders’ recidivism placement, some expected and some unexpected. Predictors that made recidivism more likely include youth with a previous conduct disorder diagnosis, a self-reported previous suicide attempt, age, and number of court offenses. Conversely, predictors that made recidivism less likely include race (Caucasian), a previous attention-deficit hyperactivity disorder diagnosis, and a misdemeanor conviction. These findings indicate that the use of a community-based suicide and mental health screening and referral approach may help to identify and assist these high-risk youth in receiving needed services prior to juvenile court involvement or during delinquency adjudication.

Paid sick leave and preventive health care service use among U.S. working adults

Managing work and health care can be a struggle for many American workers. This paper explored the relationship between having paid sick leave and receiving preventive health care services, and hypothesized that those without paid sick leave would be less likely to obtain a range of preventive care services. In 2016, cross-sectional data from a sample of 13,545 adults aged 18-64 with current paid employment from the 2015 National Health Interview Survey (NHIS) were examined to determine the relationship between having paid sick leave and obtaining eight preventive care services including: (1) blood pressure check; (2) cholesterol check; (3) fasting blood sugar check; (4) having a flu shot; (5) having seen a doctor for a medical visit; (6) getting a Pap test; (7) getting a mammogram; (8) getting tested for colon cancer. Findings from multivariable logistic regressions, holding 10 demographic, work, income, and medical related variables stable, found respondents without paid sick leave were significantly less likely to report having used six of eight preventive health services in the last 12months. The significant findings remained robust even for workers who had reported having been previously told they had risk factors related to the preventive services. These findings support the idea that without access to paid sick leave, American workers risk foregoing preventive health care which could lead to the need for medical care at later stages of disease progression and at a higher cost for workers and the American health care system as a whole.