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1.  Effect of Self-Referral on Bone Mineral Density Testing and Osteoporosis Treatment 
Medical care  2014;52(8):743-750.
Despite national guidelines recommending bone mineral density screening with dual-energy xray absorptiometry (DXA) in women ≥65 years old, many women do not receive initial screening.
To determine the effectiveness of health system and patient-level interventions designed to increase appropriate DXA testing and osteoporosis treatment through (1) an invitation to self-refer for DXA (self-referral), (2) self-referral plus patient educational materials, and (3) usual care (UC, physician referral).
Research Design
Parallel, group-randomized, controlled trials performed at Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Georgia (KPG).
Women ≥ 65 years old without a DXA in past 5 years.
DXA completion rates 90 days after intervention mailing and osteoporosis medication receipt 180 days after initial intervention mailing.
From >12,000 eligible women, those randomized to self-referral were significantly more likely to receive a DXA than UC (13.0 – 24.1% self-referral vs. 4.9 – 5.9% UC, p < 0.05). DXA rates did not significantly increase with patient educational materials. Osteoporosis was detected in a greater proportion of self-referral women compared to UC (p < 0.001). The number needed to receive an invitation to result in a DXA in KPNW and KPG regions was approximately 5 and 12, respectively. New osteoporosis prescription rates were low (0.8 – 3.4%) but significantly greater among self-referral versus UC in KPNW.
DXA rates significantly improved with a mailed invitation to schedule a scan without physician referral. Providing women the opportunity to self-refer may be an effective, low-cost strategy to increase access for recommended osteoporosis screening.
PMCID: PMC4101066  PMID: 24984211
osteoporosis; screening; DXA; randomized controlled trial
2.  Serum Urate Association with Hypertension in Young Adults: Analysis from the Coronary Artery Risk Development in Young Adults Cohort 
Annals of the rheumatic diseases  2012;72(8):1321-1327.
To determine if serum urate concentration is associated with development of hypertension in young adults.
Retrospective cohort analysis from 4752 participants with available serum urate and without hypertension at baseline from the Coronary Artery Risk Development in Young Adults (CARDIA) Study; a mixed race (African-American and White) cohort established in 1985 with 20 years of follow-up data for this analysis. Associations between baseline serum urate concentration and incident hypertension (defined as a blood pressure greater or equal to 140/90 or being on antihypertensive drugs) were investigated in sex-stratified bivariate and multivariable Cox-proportional analyses.
Mean age (standard deviation) at baseline was 24.8 (3.6) years for men and 24.9 (3.7) years for women. Compared with the referent category, we found a greater hazard of developing hypertension starting at 345 μmol/L (5.8 mg/ dL) of serum urate for men and 214 μmol/L (3.6 mg/dL) for women. There was a 25% increase in the hazard of developing hypertension in men (HR1.25 [95% CI 1.15-1.36]) per each mg/dL increase in serum urate but no significant increase in women (HR 1.06 [95%CI 0.97-1.16]).
We found a significant independent association between higher serum urate concentrations and the subsequent hazard of incident hypertension, even at concentrations below the conventional hyperuricemia threshold of 404 μmol/L (6.8 mg/dL).
PMCID: PMC4428756  PMID: 22984170
health services research; hypertension; epidemiology
3.  The Recent Prevalence of Osteoporosis and Low Bone Mass in the United States Based on Bone Mineral Density at the Femoral Neck or Lumbar Spine1 
The goal of our study was to estimate the prevalence of osteoporosis and low bone mass based on bone mineral density (BMD) at the femoral neck and the lumbar spine in adults 50 years and older in the United States (US). We applied prevalence estimates of osteoporosis or low bone mass at the femoral neck or lumbar spine (adjusted by age, sex, and race/ethnicity to the 2010 Census) for the non-institutionalized population age 50 years and older from the National Health and Nutrition Examination Survey 2005–2010 to 2010 US Census population counts to determine the total number of older US residents with osteoporosis and low bone mass. There were over 99 million adults 50 years and older in the US in 2010. Based on an overall 10.3% prevalence of osteoporosis, we estimated that in 2010 10.2 million older adults had osteoporosis. The overall low bone mass prevalence was 43.9%, from which we estimated that 43.4 million older adults had low bone mass. We estimated that 7.7 million non-Hispanic White, 0.5 million non-Hispanic Black, and 0.6 million Mexican American adults had osteoporosis and another 33.8, 2.9, and 2.0 million had low bone mass, respectively. When combined, osteoporosis and low bone mass at the femoral neck or lumbar spine affected an estimated 53.6 million older US adults in 2010. Although most of the individuals with osteoporosis or low bone mass were non-Hispanic White women, a substantial number of men and women from other racial/ethnic groups also had osteoporotic BMD or low bone mass.
PMCID: PMC4757905  PMID: 24771492
Osteoporosis; Low bone mass; Prevalence; NHANES
4.  Mortality and osteoporotic fractures: is the link causal, and is it modifiable? 
Clinical and experimental rheumatology  2008;26(5 0 51):S125-S137.
Osteoporosis is a global problem with an expected increase in f acture prevalence and public health burden as the world s population ages. Although excess mortality is well-described in those with low bone mineral density as well as those with recent hip and vertebral fractures, some uncertainty remains about whether this link is causal. Survival depends greatly on the fracture types, age, gender, and race. Deaths are predominately due to comorbidities, but may also be attributed to the fracture event itself, either directly or indirectly. The goal of osteoporosis care is prevention of fractures and ultimately reduction in morbidity and mortality. Until recently, there have been no data showing that osteoporosis treatment improves mortality, and even now the extent of these data are rather limited. Large observational cohort studies over considerable time are needed to determine whether improving osteoporosis quality of care will improve mortality rates.
PMCID: PMC4124750  PMID: 19026155
Osteoporosis; hip fractures; vertebral fractures; mortality; epidemiology
5.  Validation of Diagnostic Codes for Subtrochanteric, Diaphyseal, and Atypical Femoral Fractures Using Administrative Claims Data 
Administrative claims databases have large samples and high generalizability. They have been used to evaluate associations of atypical subtrochanteric fractures with bisphosphonates. We developed and assessed accuracy of claims-based algorithms with hospital and physician diagnosis codes for these fractures.
Medical records and radiology reports of all adults admitted at University of Alabama at Birmingham Hospital from 2004-2008 with ICD-9 hospital discharges and surgeons' fracture repair codes for subtrochanteric femoral fractures, and random sample of other femoral fractures were reviewed. An expert panel adjudicated any discordance.
We identified 137 persons with suspected subtrochanteric femoral fractures and randomly selected 50 persons with either suspected diaphyseal femoral fractures or hip fractures other than subtrochanteric and diaphyseal femoral fracture (typical hip fracture). Eleven patients had radiographic features indicative of atypical femoral fractures. The positive predictive value (PPV) of claims-based algorithms varied with primary or secondary positions on discharge diagnoses, and the sources of diagnosis codes. The PPV for fractures ranged 69-89% for subtrochanteric femoral, 89-98% for diaphyseal femoral and 85-98% for typical hip fractures. The PPV of administrative codes for defining a femoral fracture as atypical was low and imprecise.
Claims-based algorithms combining hospital discharges with surgeon's diagnosis codes had high PPV to identify the site of subtrochanteric or diaphyseal femoral fractures versus typical hip fractures. However, claims-based data were not accurate in identifying atypical femoral fractures. These claims algorithms will be useful in future population-based observational studies to evaluate associations between osteoporosis medications and subtrochanteric and diaphyseal femoral fractures.
PMCID: PMC4112756  PMID: 22071028
Atypical femoral fracture; Diagnostic Codes; Administrative Claims Data
6.  Vertebroplasty and Kyphoplasty Are Associated with an Increased Risk of Secondary Vertebral Compression Fractures A Population-based Cohort Study 
Predominantly uncontrolled studies suggest that there may be a greater risk of subsequent vertebral compression fractures (VCFs) associated with vertebroplasty and kyphoplasty. To further understand the risk of VCFs, we conducted a population-based retrospective cohort study using data from a large regional health insurer.
Materials and Methods
Administrative claims procedure codes were used to identify a treatment group of patients receiving either a vertebroplasty or kyphoplasty (treatment group) and a comparison group of patients with a primary diagnosis of VCF who did not receive treatment during the same time period. The main outcomes of interest, validated by two independent medical record reviewers and adjudicated by a physician panel, were any new VCFs within: 1) 90-days; 2) 360-days; and 3) at adjacent vertebral levels. Multivariable logistic regression examined the association of vertebroplasty/kyphoplasty with new VCFs.
Among 48 treatment (51% vertebroplasty, 49% kyphoplasty) and 164 comparison patients, treated patients had a significantly greater risk of secondary VCFs than comparison patients for fractures within 90 days of the procedure or comparison group time point (adjusted odds ratio (OR) = 6.3; 95% confidence interval (CI) 1.7 – 23.0) and within 360 days (adjusted OR = 3.1; 95% CI:1.1 – 8.4). Vertebroplasty and kyphoplasty were associated with a significantly greater rate of adjacent-level fractures as well.
Patients who had undergone vertebroplasty and kyphoplasty had a greater risk of new VCFs compared to patients with prior VCFs who did not undergo either procedure.
PMCID: PMC4089886  PMID: 18797812
7.  Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice 
Arthritis care & research  2012;64(5):640-647.
Although the systematic measurement of disease activity facilitates clinical decision making in rheumatoid arthritis (RA), no recommendations currently exist on which measures should be applied in clinical practice in the US. The American College of Rheumatology (ACR) convened a Working Group (WG) to comprehensively evaluate the validity, feasibility, and acceptability of available RA disease activity measures and derive recommendations for their use in clinical practice.
The Rheumatoid Arthritis Clinical Disease Activity Measures Working Group conducted a systematic review of the literature to identify RA disease activity measures. Using exclusion criteria, input from an Expert Advisory Panel (EAP), and psychometric analysis, a list of potential measures was created. A survey was administered to rheumatologists soliciting input. The WG used these survey results in conjunction with the psychometric analyses to derive final recommendations.
Systematic review of the literature resulted in identification of 63 RA disease activity measures. Application of exclusion criteria and ratings by the EAP narrowed the list to 14 measures for further evaluation. Practicing rheumatologists rated 9 of these 14 measures as most useful and feasible. From these 9 measures, the WG selected 6 with the best psychometric properties for inclusion in the final set of ACR-recommended RA disease activity measures.
We recommend the Clinical Disease Activity Index, Disease Activity Score with 28-joint counts (erythrocyte sedimentation rate or C-reactive protein), Patient Activity Scale (PAS), PAS-II, Routine Assessment of Patient Index Data with 3 measures, and Simplified Disease Activity Index because they are accurate reflections of disease activity; are sensitive to change; discriminate well between low, moderate, and high disease activity states; have remission criteria; and are feasible to perform in clinical settings.
PMCID: PMC4028066  PMID: 22473918
8.  The Relationship of Cardiovascular Risk in Rheumatoid Arthritis Comparing TNFα Blockade with Non-Biologic DMARDs 
The American journal of medicine  2013;126(8):730.e9-730.e17.
Elevated TNFα likely contributes to the excess cardiovascular risk observed in rheumatoid arthritis. We compared the cardiovascular risk in rheumatoid arthritis patients starting a TNFα blocking agent versus a non-biologic disease-modifying anti-rheumatic drug (nbDMARD).
Subjects with rheumatoid arthritis participating in several different US insurance programs between 1998-2007 who received methotrexate were eligible. Those who added a TNFα blocking agent were compared with subjects who added a nbDMARD in Cox regression models stratified by propensity score decile and adjusted for oral glucocorticoid dosage. We examined the composite cardiovascular endpoint of myocardial infarction, stroke, or coronary re-vascularization after six months.
We compared 8,656 new users of a nbDMARD with 11,587 new users of a TNFα blocking agent with similar baseline covariates. Incidence rates per 100 person-years for the composite cardiovascular endpoint were 3.05 (95% CI 2.54 – 3.65) for nbDMARDs and 2.52 (95% CI 2.12-2.98) for TNFα blocking agents. The hazard ratio (HR) for the TNFα blocking agent compared with nbDMARD carrying the first exposure forward was 0.80 (95% CI 0.62 - 1.04), while the HR for the as-treated analysis was 0.71 (95% CI 0.52 - 0.97). The potential cardiovascular benefit of TNFα blocking agents was strongest among persons ≥ 65 years of age (HR 0.52, 95% CI 0.34 – 0.77; p for interaction = 0.075).
Among subjects with rheumatoid arthritis, TNFα blocking agents may be associated with a reduced risk of cardiovascular events compared to a nbDMARD. Randomized controlled clinical trials should be considered to test this hypothesis.
PMCID: PMC4674813  PMID: 23885678
rheumatoid arthritis; TNFα blocking agents; cardiovascular disease
9.  Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size 
Pragmatic clinical trials (PCTs) provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS) for patient recruitment and screening for an osteoporosis PCT in community physician offices.
Materials and methods
We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.
A total of 160 women (80% of those approached) agreed to complete the osteoporosis screening questions in ten family physicians’ offices. Women using the tablet computer were able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician’s office compared to those using IVRS. Using the proportion of women found to be eligible in this study (almost 20%) and other eligibility scenarios, we determined that between 240 and 670 community physician offices would be needed to recruit ample patients for our hypothetical study.
We found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings. In addition, we used this experience to estimate the number of research sites needed for such a study.
PMCID: PMC3685447  PMID: 23807841
osteoporosis; clinical trial; pragmatic clinical trials; computer applications
10.  The Validity of Claims-Based Algorithms to Identify Serious Hypersensitivity Reactions and Osteonecrosis of the Jaw 
PLoS ONE  2015;10(7):e0131601.
Validation of claims-based algorithms to identify serious hypersensitivity reactions and osteonecrosis of the jaw has not been performed in large osteoporosis populations. The objective of this project is to estimate the positive predictive value of the claims-based algorithms in older women with osteoporosis enrolled in Medicare. Using the 2006-2008 Medicare 5% sample data, we identified potential hypersensitivity and osteonecrosis of the jaw cases based on ICD-9 diagnosis codes. Potential hypersensitivity cases had a 995.0, 995.2, or 995.3 diagnosis code on emergency department or inpatient claims. Potential osteonecrosis of the jaw cases had ≥1 inpatient or outpatient physician claim with a 522.7, 526.4, 526.5, or 733.45 diagnosis code or ≥2 claims of any type with a 526.9 diagnosis code. All retrieved records were redacted and reviewed by experts to determine case status: confirmed, not confirmed, or insufficient information. We calculated the positive predictive value as the number of confirmed cases divided by the total number of retrieved records with sufficient information. We requested 412 potential hypersensitivity and 304 potential osteonecrosis of the jaw records and received 174 (42%) and 84 (28%) records respectively. Of 84 potential osteonecrosis of the jaw cases, 6 were confirmed, resulting in a positive predictive value (95% CI) of 7.1% (2.7, 14.9). Of 174 retrieved potential hypersensitivity records, 95 were confirmed. After exclusion of 25 records with insufficient information for case determination, the overall positive predictive value (95% CI) for hypersensitivity reactions was 76.0% (67.5, 83.2). In a random sample of Medicare data, a claim-based algorithm to identify serious hypersensitivity reactions performed well. An algorithm for osteonecrosis of the jaw did not, partly due to the inclusion of diagnosis codes that are not specific for osteoporosis of the jaw.
PMCID: PMC4498926  PMID: 26161858
11.  Long-term Safety Concerns of Antiresorptive Therapy 
Bisphosphonates prevent the loss of bone mineral content by inhibiting bone resorption. As a result, bone turnover is decreased and bone mineral density maintained or even increased. Currently, bisphosphonates account for approximately 80% of all medications prescribed for osteoporosis.1 Although these medications were well tolerated and safe during large-scale clinical trials, several rare and potentially serious adverse events are reported to be associated with long-term bisphosphonate use from postmarketing reports and epidemiologic studies. These adverse events include osteonecrosis of the jaw (ONJ), atypical fractures, and esophageal cancer. This review summarizes studies examining the association between long-term bisphosphonate use and these adverse outcomes.
PMCID: PMC4420195  PMID: 22023898
Osteoporosis; Anti-resorptive therapy; Safety concerns
12.  Febuxostat: the evidence for its use in the treatment of hyperuricemia and gout 
Core evidence  2010;4:25-36.
Gout is a common and disabling cause of arthritis in middle-aged and elderly populations, with its main predisposing factor being hyperuricemia (serum urate > 6.8 mg/dL). Options for treatment of chronic gout until 2008 were allopurinol, a xanthine oxidase inhibitor, and the group of drugs known as uricosurics that stimulate the renal excretion of uric acid. A proportion of patients, including some with chronic kidney disease and solid organ transplantations, could not be treated with the those therapies because of intolerance, drug interactions, or adverse events. Febuxostat is a nonpurine xanthine oxidase inhibitor, recently approved in Europe and the United States for the treatment of chronic gout.
To review the clinical evidence (phase II and III studies) of the effectiveness and safety of febuxostat for treatment of hyperuricemia and gout.
Evidence review:
Febuxostat, at doses ranging from 40 to 240 mg/day, is efficacious in reducing serum urate in patients with hyperuricemia and gout, comparing favorably with fixed doses of allopurinol in that respect. Early safety signals with respect to liver test abnormalities and cardiovascular outcomes have not been confirmed in recent large prospective trials but need to be further monitored.
Clinical potential:
Given its low cost and extensive clinical experience, allopurinol will likely remain the first-line drug for management of hyperuricemia and gout. Febuxostat may provide an important option in patients unable to use allopurinol, those with very high serum urate levels, or in the presence of refractory tophi.
PMCID: PMC2899777  PMID: 20694062
febuxostat; gout; hyperuricemia; evidence
13.  Death, Debility, and Destitution Following Hip Fracture 
We examined the effects of hip fracture on mortality, entry into long-term institutional care, and new evidence of poverty. We estimate of the proportion of hip fracture patients who require not just short-term rehabilitation but who become dependent on long-term institutional care, and the risk of becoming newly dependent on Medicaid or eligible for low-income subsidies following hip fracture.
We used data from 2005 through 2010 for a random 5% sample of Medicare beneficiaries (N = 3.1 million) to conduct a retrospective matched cohort study. We used high-dimensional propensity score matching to compare outcomes for patients who experienced a hip fracture with subjects who did not, but had similar propensity for suffering a hip fracture. We then compared the 1-year risk of death, debility, and destitution between groups.
We matched 43,210 hip fracture patients to comparators without a hip fracture. Hip fractures were associated with more than a twofold increase in likelihood of mortality (incidence proportion ratio [IPR] of 2.27, 95% CI, 2.20–2.34), a fourfold increase in likelihood of requiring long-term nursing facility care (IPR, 3.96; 95% CI, 3.77–4.16), and a twofold increase in the probability of entering into low-income status (IPR, 2.14; 95% CI 1.99–2.31) within 1 year following hip fracture compared with subjects without a hip fracture.
Hip fracture in elderly patients resulted in increased death, debility, and destitution. Initiatives that lead to improved treatment of osteoporosis could result in a decrease in incidence of fractures, subsequent death, debility, and destitution for older adults.
PMCID: PMC3976138  PMID: 23873945
Hip fracture; High-dimensional propensity score; Mortality; Osteoporosis.
14.  Use of Health Plan Combined with Registry Data to Predict Clinical Trial Recruitment 
Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients age ≥ 50 receiving anti- tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4,000 patients needed for the trial and to facilitate site selection.
Using national United States data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients’ treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients.
Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1,980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 40-45 largest rheumatology practices.
Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.
PMCID: PMC4199104  PMID: 24346611
pragmatic trial; clinical trial; registry; administrative data; recruitment; rheumatoid arthritis; anti-TNF therapy; herpes zoster; shingles
15.  Non-viral Opportunistic Infections in New Users of TNF Inhibitor Therapy: Results of the SAfety Assessment of Biologic ThERapy (SABER) Study 
Annals of the rheumatic diseases  2013;73(11):1942-1948.
To determine among patients with autoimmune diseases in the United States whether the risk of non-viral opportunistic infections (OIs) was increased among new users of tumor necrosis factor-alpha inhibitors (TNFI), when compared to users of non-biologic agents used for active disease.
We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis-psoriatic arthritis-ankylosing spondylitis (PsO-PsA-AS) patients during 1998–2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programs for the elderly, Tennessee Medicaid, and US Medicaid/Medicare programs. We compared incidence of non-viral OIs among new TNFI users and patients initiating non-biologic disease modifying drugs (DMARDs) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biologic DMARD users.
Within a cohort of 33,324 new TNFI users we identified 80 non-viral OIs, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OIs among new users of TNFI as compared to those initiating non-biologic DMARDs was 2.7 verus 1.7 per 1000-person years[adjusted hazard ratio (aHR): 1.6, 95% CI: 1.0, 2.6)]. Baseline corticosteroid use was associated with non-viral OIs (aHR 2.5, 95% CI: 1.5, 4.0). In the RA cohort, rates of non-viral OIs among new users of infliximab were higher when compared to patients newly starting non-biologic DMARDs (aHR 2.6, 95% CI 1.2, 5.6) or new etanercept users (aHR 2.9, 95% CI: 1.5, 5.4).
In the US, the rate of non-viral OIs was higher among new users of TNFI with autoimmune diseases as compared to non-biologic DMARD users.
PMCID: PMC4273901  PMID: 23852763
opportunistic infection; tumor necrosis factor-alpha; Pneumocystis; tuberculosis; rheumatoid arthritis
16.  Prevention and Treatment of Bone Changes Associated with Exposure to Glucocorticoids 
Current osteoporosis reports  2013;11(4):341-347.
Rheumatologic diseases are associated with a pro-inflammatory state which is thought to lead to many of the bone changes seen in treatment-naive patients. However, glucocorticoids remain a common treatment option for rheumatologic diseases and are known to have a negative impact on bone through direct effects on bone cells and indirect effects on calcium absorption. Despite the anti-inflammatory effect of glucocorticoids, fracture risk rises within the first three months of treatment. As such, osteoporosis prevention and treatment need to be considered in all patients started on chronic glucocorticoids (≥3 months of treatment). For very low risk patients, conservative management with non-pharmacologic strategies may be appropriate. For the moderate to high fracture risk patients treated with glucocorticoids, pharmacologic treatment with one of the four approved medications should be considered. The challenge of educating physicians and patients of the risks of glucocorticoid induced osteoporosis remain.
PMCID: PMC4047972  PMID: 24097304
Osteoporosis; Glucocorticoid; Treatment; Teriparatide; Bisphosphonates; Calcium; Vitamin D; Rheumatoid Arthritis; Lupus; Ankylosing Spondylitis
17.  Improving bone mineral density reporting to patients with an illustration of personal fracture risk 
To determine patients’ preferences for, and understanding of, FRAX® fracture risk conveyed through illustrations.
Drawing on examples from published studies, four illustrations of fracture risk were designed and tested for patient preference, ease of understanding, and perceived risk. We enrolled a convenience sample of adults aged 50 and older at two medical clinics located in the Midwestern and Southern United States. In-person structured interviews were conducted to elicit patient ranking of preference, ease of understanding, and perceived risk for each illustration.
Most subjects (n = 142) were female (64%), Caucasian (76%) and college educated (78%). Of the four risk depictions, a plurality of participants (37%) listed a bar graph as most preferred. Subjects felt this illustration used the stoplight color system to display risk levels well and was the most “clear,” “clean,” and “easy to read”. The majority of subjects (52%) rated the pictogram as the most difficult to understand as this format does not allow people to quickly ascertain their individual risk category.
Communicating risk to patients with illustrations can be done effectively with clearly designed illustrations responsive to patient preference.
Trial Registration Identifier: NCT01507662
PMCID: PMC4260260  PMID: 25743200
Osteoporosis; DXA Scan; Risk; Fracture; Bone; Patient education
18.  OMERACT endorsement of measures of outcome for studies of acute gout 
The Journal of rheumatology  2013;41(3):569-573.
To determine the extent to which OMERACT participants agree that instruments that have been used in clinical trials and measure OMERACT core outcome domains in acute gout fulfil the filter requirements of truth, discrimination and feasibility and to determine where future research efforts need to be directed.
The results of a systematic literature review and analysis of individual-level data from recent clinical studies of acute gout were presented to OMERACT participants. The information was discussed in breakout groups and opinion was defined by subsequent voting in a plenary session. Endorsement was defined as at least 70% of participants voting in agreement with the proposition (where the denominator excluded those participants who did not vote or who voted ‘don’t know’).
The following measures were endorsed for use in clinical trials of acute gout: (1) 5-point Likert scale and/or VAS (0 to 100mm) to measure pain; (2) 4-point Likert scale for joint swelling; (3) 4-point Likert scale for joint tenderness; and (4) 5-point Likert scale for patient global assessment of response to treatment. Measures for the activity limitations domain were not endorsed.
Measures of pain, joint swelling, joint tenderness and patient global assessment in acute gout were endorsed at OMERACT-11. These measures should now be used in clinical trials of acute gout.
PMCID: PMC4162875  PMID: 24334651
gout; outcome measures; psychometrics
19.  Serum urate levels and consumption of common beverages and alcohol among Chinese in Singapore 
Arthritis care & research  2013;65(9):1432-1440.
Western studies suggest that beverages may affect serum urate (SU) levels but data from Asian populations are scarce. We evaluated the associations between beverages and SU levels in Singapore Chinese.
The study population consisted of 483 subjects from the Singapore Chinese Health Study cohort, aged 45-74 years, recruited between 1993 and 1998. Lifestyle factors, medical histories and diet were collected through in-person interviews. SU and other biomarkers were measured from blood collected between 1994 and 1996.
Mean age was 57.6 years and 44% were men. The geometric mean of SU was 321 μmol/L (range 157-719 μmol/L). Mean SU levels increased with alcohol consumption (P for trend = 0.024). The mean SU level of daily alcohol drinkers was 42.6 μmol/L higher than that of non-drinkers. Similarly, increasing frequency of green tea intake was associated with rising SU levels. The highest mean SU level was observed in daily green tea drinkers (difference of 25.0 μmol/L) relative to non-drinkers (P for trend = 0.009). Compared to non-drinkers, daily alcohol drinkers had an almost 5-fold increase in association with hyperuricaemia [odds ratio (OR) = 4.83; 95% confidence interval (CI) = 1.10-21.23) while daily green tea drinkers had a 2-fold increase in association with hyperuricaemia (OR=2.12, 95% CI=1.03-4.36). The present study did not show elevated levels of SU in individuals who consumed black tea, coffee, fruit juice or soda.
Alcohol consumption increases SU levels. The finding that daily drinking of green tea is associated with hyperuricaemia needs validation in future studies.
PMCID: PMC3710722  PMID: 23463601
serum urate; coffee; tea; soft drinks; fruit juice; alcohol; Chinese
20.  Obesity, Healthcare Utilization and Health-Related Quality of Life after Fracture in Postmenopausal Women: Global Longitudinal Study of Osteoporosis in Women (GLOW) 
Calcified tissue international  2014;94(2):223-231.
Fractures in obese postmenopausal women may be associated with higher morbidity than in non-obese women. We aimed to compare healthcare utilization, functional status, and health-related quality of life (HRQL) in obese, non-obese and underweight women with fractures. Information from GLOW, started in 2006, was collected at baseline and at 1, 2 and 3 years. In this subanalysis, self-reported incident clinical fractures, healthcare utilization, HRQL and functional status were recorded and examined. Women in GLOW (n = 60,393) were aged ≥55 years, from 723 physician practices at 17 sites in 10 countries. Complete data for fracture and body mass index were available for 90 underweight, 3,270 non-obese and 941 obese women with ≥1 incident clinical fracture during the 3-year follow-up. The median hospital length of stay, adjusted for age, comorbidities and fracture type, was significantly greater in obese than non-obese women (6 vs. 5 days, P = 0.017). Physical function and vitality score were significantly worse in obese than in non-obese women, both before and after fracture, but changes after fracture were similar across groups. Use of anti-osteoporosis medication was significantly lower in obese than in non-obese or underweight women. In conclusion, obese women with fracture undergo a longer period of hospitalization for treatment and have poorer functional status and HRQL than non-obese women. Whether these differences translate into higher economic costs and adverse effects on longer-term outcomes remains to be established.
PMCID: PMC3917823  PMID: 24077896
Fractures; Healthcare utilization; Functional status; Quality of life; Obesity
21.  Biologics and heart failure in rheumatoid arthritis: are we any wiser? 
Current opinion in rheumatology  2008;20(3):327-333.
Purpose of review
To summarize the recent literature concerning the role of TNF-a in heart failure, epidemiology of heart failure in rheumatoid arthritis and risk of heart failure associated with biologic disease-modifying antirheumatic drugs in rheumatoid arthritis.
Recent findings
TNF-a has been implicated in the pathogenesis of heart failure. It has direct deleterious effects on the myocardium in the setting of acute injury or chronic heart failure. In animal models, TNF-a is important in cardiac remodeling, leading to cardiac dysfunction following acute injury. Both incident and worsening heart failure have been reported in patients with rheumatoid arthritis who are treated with anti-TNF-a therapy. Recent cohort studies, however, have shown no increased risk and, in some, a protective effect on the risk of heart failure. Certain traditional cardiovascular risk factors have a relatively lesser contribution to cardiovascular morbidity and mortality in patients with rheumatoid arthritis, suggesting that disease-related perturbations of the cytokine network may contribute to the excess risk of heart failure in these patients.
Overall mortality in rheumatoid arthritis has remained stagnant despite advances in rheumatoid arthritis and heart failure management and improved cardiovascular mortality in the general population. Heart failure prevalence is increased in patients with rheumatoid arthritis and leads to greater mortality. Despite current expert consensus contraindicating the use of anti-TNF-a agents in patients with moderate to severe heart failure, epidemiological studies in rheumatoid arthritis have not consistently substantiated this association.
PMCID: PMC4097098  PMID: 18388526
anti-TNF-a agents; biologic disease-modifying antirheumatic drugs; heart failure; rheumatoid arthritis
22.  Multimodal Intervention to Improve Osteoporosis Care in Home Health Settings: Results from a Cluster Randomized Trial 
To test an evidence-implementation intervention to improve the quality of care in the home health care setting for patients at high risk for fractures.
We conducted a cluster randomized trial of a multimodal intervention targeted at home care for high-risk patients (prior fracture or physician-diagnosed osteoporosis) receiving care in a statewide home health agency in Alabama. Offices throughout the state were randomized to receive the intervention or to usual care. The primary outcome was the proportion of high-risk home health patients treated with osteoporosis medications. A t-test of difference in proportions was conducted between intervention and control arms and constituted the primary analysis. Secondary analyses included logistic regression estimating the effect of individual patients being treated in an intervention arm office on the likelihood of a patient receiving osteoporosis medications. A follow-on analysis examined the effect of an automated alert built into the electronic medical record that prompted the home health care nurses to deploy the intervention for high risk patients using a pre-post design.
Among the offices in the intervention arm the average proportion of eligible patients receiving osteoporosis medications post-intervention was 19.1%, compared with 15.7% in the usual care arm (difference in proportions 3.4%, 95% CI: −2.6 −9.5%). The overall rates of osteoporosis medication use increased from 14.8% prior to activation of the automated alert to 17.6% afterward, a non-significant difference.
The home health intervention did not result in a significant improvement in use of osteoporosis medications in high risk patients.
PMCID: PMC4089895  PMID: 23536256
Osteoporosis; Home Care Services; Quality Improvement; Secondary Prevention
24.  Developing a bone mineral density test result letter to send to patients: a mixed-methods study 
To use a mixed-methods approach to develop a letter that can be used to notify patients of their bone mineral density (BMD) results by mail that may activate patients in their bone-related health care.
Patients and methods
A multidisciplinary team developed three versions of a letter for reporting BMD results to patients. Trained interviewers presented these letters in a random order to a convenience sample of adults, aged 50 years and older, at two different health care systems. We conducted structured interviews to examine the respondents’ preferences and comprehension among the various letters.
A total of 142 participants completed the interview. A majority of the participants were female (64.1%) and white (76.1%). A plurality of the participants identified a specific version of the three letters as both their preferred version (45.2%; P<0.001) and as the easiest to understand (44.6%; P<0.01). A majority of participants preferred that the letters include specific next steps for improving their bone health.
Using a mixed-methods approach, we were able to develop and optimize a printed letter for communicating a complex test result (BMD) to patients. Our results may offer guidance to clinicians, administrators, and researchers who are looking for guidance on how to communicate complex health information to patients in writing.
PMCID: PMC4051798  PMID: 24940049
osteoporosis; DXA; test results; patient education; fracture risk; patient activation
25.  Improving osteoporosis care in high-risk home health patients through a high intensity intervention 
Contemporary clinical trials  2011;33(1):206-212.
We developed and tested a multi-modal intervention, delivered in the home health care setting, aimed at increasing osteoporosis treatment rates to prevent fractures.
Material and Methods
The intervention focused on home health nurses. Key components included: nursing education; development of a nursing care plan; patient teaching materials and creation of physician materials. Nursing education consisted of a lecture covering osteoporosis, fracture risks and prevention, and the effectiveness of anti-osteoporosis treatment options. Patients received education materials concerning osteoporosis and anti-osteoporosis medications. A pocket-sized treatment algorithm card and standardized order sets were prepared for physicians. Focus groups of physicians and nurses were conducted to obtain feedback on the materials and methods to facilitate effective nurse-physician communication. Successful application required nurses to identify patients with a fracture history, initiate the care plan, prompt physicians on risk status, and provide patient education. The intervention was piloted in one field office.
In the year prior to the intervention, home health patients (n=92) with a fracture history were identified in the pilot field office and only 20 (22%) received osteoporosis prescription therapy. In the three months following the intervention, 21 newly enrolled patients were identified and 9 (43%) had received osteoporosis prescription medications.
Home health care provides a venue where patients and physicians can be informed by nurses about osteoporosis and fracture risks and, consequently, initiate appropriate therapy. This multi-modal intervention is easily transportable to other home health agencies and adaptable to other medical conditions and settings.
PMCID: PMC4045407  PMID: 22005175
osteoporosis; home health; fracture; dissemination; cluster randomized trial; patient education

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