Elizabeth A. Chrischilles

How Many Women Have Osteoporosis

Osteoporosis is widely viewed as a major public health concern, but the exact magnitude of the problem is uncertain and likely to depend on how the condition is defined. Noninvasive bone mineral measurements can be used to define a state of heightened fracture risk (osteopenia), or the ultimate clinical manifestation of fracture can be assessed (established osteoporosis). If bone mineral measurements more than 2 standard deviations below the mean of young normal women represent osteopenia, then 45% of white women aged 50 years and over have the condition at one or more sites in the hip, spine, or forearm on the basis of population‐based data from Rochester, Minnesota. A smaller proportion is affected at each specific skeletal site: 32% have bone mineral values this low in the lumbar spine, 29% in either of two regions in the proximal femur, and 26% in the midradius. Although this overall estimate is substantial, some other serious chronic diseases are almost as common. More importantly, low bone mass is associated with adverse health outcomes, especially fractures. The lifetime risk of any fracture of the hip, spine, or distal forearm is almost 40% in white women and 13% in white men from age 50 years onward. If the enormous costs associated with these fractures are to be reduced, increased attention must be given to the design and implementation of control programs directed at this major health problem.

Improved Survival of Follicular Lymphoma Patients in the United States

PURPOSE Despite several new treatment options, single- and multi-institution analyses have not clarified whether survival patterns in follicular lymphoma (FL) patients have changed in recent decades. We undertook a study using a large population-based registry to analyze survival patterns among patients with FL. PATIENTS AND METHODS Surveillance, Epidemiology, and End Results morphology codes were used to identify 14,564 patients diagnosed with FL between 1978 and 1999. Observed median survival times, Kaplan-Meier survival curves, proportional death hazard ratios, and relative survival rates were calculated. Joinpoint regression analysis was used to identify trends in annual adjusted death hazard ratios. RESULTS An improvement in survival of all patients with FL was observed between each of three diagnosis eras (1978 to 1985, 1986 to 1992, and 1993 to 1999) by log-rank tests. Among patients with stage-specific data, the median survival time improved from 84 months (95% CI, 81 to 88 months) in the 1983 to 1989 era to 93 months (95% CI, 89 to 97 months) in the 1993 to 1999 era. Similar findings were identified across sex and age groups and for subsets including advanced-stage, large-cell FL and the combined subset of small cleaved- and mixed-cell FL. The inter-era survival advantage observed in white patients was not observed for black patients. The relative risk of death decreased by 1.8% per year over the 1983 to 1999 observation period. CONCLUSION The survival of patients with FL in the United States has improved over the last 25 years. The survival improvement may be a result of the sequential application of effective therapies and improved supportive care.

Physician and pharmacist collaboration to improve blood pressure control.

BACKGROUND Studies have demonstrated that blood pressure (BP) control can be improved when clinical pharmacists assist with patient management. The objective of this study was to evaluate if a physician and pharmacist collaborative model in community-based medical offices could improve BP control. METHODS This was a prospective, cluster randomized, controlled clinical trial with clinics randomized to a control group (n = 3) or to an intervention group (n = 3). The study enrolled 402 patients (mean age, 58.3 years) with uncontrolled hypertension. Clinical pharmacists made drug therapy recommendations to physicians based on national guidelines. Research nurses performed BP measurements and 24-hour BP monitoring. RESULTS The mean (SD) guideline adherence scores increased from 49.4 (19.3) at baseline to 53.4 (18.1) at 6 months (8.1% increase) in the control group and from 40.4 (22.6) at baseline to 62.8 (13.5) at 6 months (55.4% increase) in the intervention group (P = .09 for adjusted between-group comparison). The mean BP decreased 6.8/4.5 mm Hg in the control group and 20.7/9.7 mm Hg in the intervention group (P < .05 for between-group systolic BP comparison). The adjusted difference in systolic BP was -12.0 (95% confidence interval [CI], -24.0 to 0.0) mm Hg, while the adjusted difference in diastolic BP was -1.8 (95% CI, -11.9 to 8.3) mm Hg. The 24-hour BP levels showed similar effect sizes. Blood pressure was controlled in 29.9% of patients in the control group and in 63.9% of patients in the intervention group (adjusted odds ratio, 3.2; 95% CI, 2.0-5.1; P < .001). CONCLUSIONS A physician and pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates compared with a control group. Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00201019.

The U.S. Food and Drug Administration's Mini‐Sentinel program: status and direction

The Mini‐Sentinel is a pilot program that is developing methods, tools, resources, policies, and procedures to facilitate the use of routinely collected electronic healthcare data to perform active surveillance of the safety of marketed medical products, including drugs, biologics, and medical devices. The U.S. Food and Drug Administration (FDA) initiated the program in 2009 as part of its Sentinel Initiative, in response to a Congressional mandate in the FDA Amendments Act of 2007.

The Aftermath of Hip Fracture: Discharge Placement, Functional Status Change, and Mortality

The authors prospectively explored the consequences of hip fracture with regard to discharge placement, functional status, and mortality using the Survey on Assets and Health Dynamics Among the Oldest Old (AHEAD). Data from baseline (1993) AHEAD interviews and biennial follow-up interviews were linked to Medicare claims data from 1993-2005. There were 495 postbaseline hip fractures among 5,511 respondents aged >or=69 years. Mean age at hip fracture was 85 years; 73% of fracture patients were white women, 45% had pertrochanteric fractures, and 55% underwent surgical pinning. Most patients (58%) were discharged to a nursing facility, with 14% being discharged to their homes. In-hospital, 6-month, and 1-year mortality were 2.7%, 19%, and 26%, respectively. Declines in functional-status-scale scores ranged from 29% on the fine motor skills scale to 56% on the mobility index. Mean scale score declines were 1.9 for activities of daily living, 1.7 for instrumental activities of daily living, and 2.2 for depressive symptoms; scores on mobility, large muscle, gross motor, and cognitive status scales worsened by 2.3, 1.6, 2.2, and 2.5 points, respectively. Hip fracture characteristics, socioeconomic status, and year of fracture were significantly associated with discharge placement. Sex, age, dementia, and frailty were significantly associated with mortality. This is one of the few studies to prospectively capture these declines in functional status after hip fracture.

A Cluster Randomized Trial to Evaluate Physician/Pharmacist Collaboration to Improve Blood Pressure Control

This was a prospective, cluster randomized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years (mean, 61 years). Pharmacists made recommendations to physicians for patients in the intervention clinics (n=101) but not patients in the control clinics (n=78). The mean adjusted difference in systolic blood pressure (BP) between the control and intervention groups was 8.7 mm Hg (95% confidence interval [CI], 4.4–12.9), while the difference in diastolic BP was 5.4 mm Hg (CI, 2.8–8.0) at 9 months. The 24‐hour BP levels showed similar effects, with a mean systolic BP level that was 8.8 mm Hg lower (CI, 5.0–12.6) and a mean diastolic BP level that was 4.6 mm Hg (CI, 2.4–6.8) lower in the intervention group. BP was controlled in 89.1% of patients in the intervention group and 52.9% in the control group (adjusted odds ratio, 8.9; CI, 3.8–20.7; P<.001). Physician/pharmacist collaboration achieved significantly better mean BP values and overall BP control rates, primarily by intensification of medication therapy and improving patient adherence.

Evaluation of hypertensive patients after care provided by community pharmacists in a rural setting.

We evaluated blood pressure control, quality of life, quality of care, and satisfaction of patients who were monitored by specially trained community pharmacists in a group medical practice. After participating in an intensive skill development program, pharmacists performed in an interdisciplinary team in a rural clinic. The primary objective was assessed by evaluating outcome variables at 6 months compared with baseline in 25 patients randomly assigned to a study group. A control group of 26 patients was also evaluated to determine if outcome variables remained constant from baseline to 6 months. Systolic blood pressure was reduced in the study group (151 mm Hg baseline, 140 mm Hg at 6 mo, p<0.001) and diastolic blood pressure was significantly lower at 2, 4, and 5 months compared with baseline. Ratings from a blinded peer review panel indicated significant improvement in the appropriateness of the blood pressure regimen, going from 8.7 ± 4.7 to 10.9 ± 4.5 in the study group (p<0.01), but they did not change in the control group. Several quality of life scores improved significantly in the study group after 6 months (p<0.05). These included physical functioning (61.6 vs 70.7), physical role limitations (56.8 vs 72.8), and bodily pain (60.0 vs 71.7) at baseline and 6 months, respectively. There were no significant changes in the control group. Patient satisfaction scores were consistently higher in the study group at the end of the study. Our results indicate that when community pharmacists in a clinic setting are trained and included as members of the primary care team, significant improvements in blood pressure control, quality of life, and patient satisfaction can be achieved.

Inappropriate Prescribing Predicts Adverse Drug Events in Older Adults

BACKGROUND Explicit measures of potentially inappropriate prescribing, such as the Beers criteria, have been associated with risk for adverse drug events (ADEs). However, no such link has been established for actual inappropriate prescribing using implicit measures. OBJECTIVE To determine whether an implicit measure of inappropriate prescribing can predict ADE risk. METHODS Patients were veterans aged 65 years and older who were seen in primary care clinics and participated in a randomized controlled trial of a pharmacist-physician collaborative intervention. Inappropriate prescribing was determined at baseline, using the 2003 Beers criteria as an explicit measure and the Medication Appropriateness Index (MAI) as an implicit measure. A modified MAI scoring approach was designed to target ADE risk and was used in addition to standard scoring. ADEs that occurred during the 3 months following baseline were assessed by patient interview and plausibility verification by blinded pharmacist review. Logistic regression analysis was used to determine whether inappropriate prescribing predicted risk for an ADE, controlling for potential confounding factors. RESULTS Of 236 patients, 34 (14.4%) experienced an ADE. Inappropriate prescribing was common at baseline, with 48.7% of patients receiving a Beers criteria drug and 98.7% of patients having an inappropriate rating on at least 1 MAI criterion. Modified MAI scoring, but not other measures of inappropriate prescribing, significantly predicted ADE risk. For every unit increase in modified MAI score (3.1 +/- 3.5; mean +/- SD), the adjusted 3-month odds of an ADE increased 13% (OR 1.13; 95% CI 1.02 to 1.26). For example, patients with a modified MAI score of 3, near the precise mean score of 3.1, were at a nearly 40% greater risk for an ADE compared with patients with a score of zero. CONCLUSIONS Implicit measurement of actual inappropriate prescribing predicted ADE risk, an important clinical outcome. This finding helps confirm the validity of prior studies that have relied on explicit measures to link potentially inappropriate prescribing to adverse health outcomes.

Self-reported adverse drug reactions and related resource use : a study of community-dwelling persons 65 years of age and older

OBJECTIVE To describe the incidence and health resource consequences of self-reported adverse drug reactions (ADRs) and their relation to self-perceived health, number of medications used, and age in a geographically based population 65 years of age and older. DESIGN A survey of a defined population. PARTICIPANTS Three thousand, one hundred seventy noninstitutionalized persons 65 years of age and older residing in two Iowa counties. MEASUREMENTS Reports of ADRs (elicited using an open-ended questionnaire); names of drugs involved; descriptions of reactions and related health resource use; self-perceived health status (at the first annual follow-up); and number of medications (from the baseline interview). RESULTS Ten percent (95% CI, 8.97 to 11.09) of respondents reported one or more ADRs. Three quarters of respondents who reported ADRs contacted a physician. Of these, half indicated that a laboratory test had been ordered, and 7% reported a hospitalization due to the reaction. Advanced age alone was associated with decreased risk in women; a similar trend in men was not statistically significant. However, persons with poorer health status and those who reported the greatest prior use of medications were most likely to report reactions. CONCLUSIONS In this study of noninstitutionalized elderly persons, advanced age did not appear to be associated with increased risk for self-reported ADRs. We could not determine whether the decrease in ADR reports among the oldest respondents represented true diminished ADR occurrence or altered ADR detection and reporting capabilities. When projected to the elderly community-dwelling U.S. population, 2.2 million annual physician visits, 1.1 million laboratory tests, and 146,000 hospitalizations may result from ADRs.

Asthma and Farm Exposures in a Cohort of Rural Iowa Children

Epidemiologic studies of farm children are of international interest because farm children are less often atopic, have less allergic disease, and often have less asthma than do nonfarm children—findings consistent with the hygiene hypothesis. We studied a cohort of rural Iowa children to determine the association between farm and other environmental risk factors with four asthma outcomes: doctor-diagnosed asthma, doctor-diagnosed asthma/medication for wheeze, current wheeze, and cough with exercise. Doctor-diagnosed asthma prevalence was 12%, but at least one of these four health outcomes was found in more than a third of the cohort. Multivariable models of the four health outcomes found independent associations between male sex (three asthma outcomes), age (three asthma outcomes), a personal history of allergies (four asthma outcomes), family history of allergic disease (two asthma outcomes), premature birth (one asthma outcome), early respiratory infection (three asthma outcomes), high-risk birth (two asthma outcomes), and farm exposure to raising swine and adding antibiotics to feed (two asthma outcomes). The high prevalence of rural childhood asthma and asthma symptoms underscores the need for asthma screening programs and improved asthma diagnosis and treatment. The high prevalence of asthma health outcomes among farm children living on farms that raise swine (44.1%, p = 0.01) and raise swine and add antibiotics to feed (55.8%, p = 0.013), despite lower rates of atopy and personal histories of allergy, suggests the need for awareness and prevention measures and more population-based studies to further assess environmental and genetic determinants of asthma among farm children.