Rheumatol Int (2012) 32:3619–3624 DOI 10.1007/s00296-011-2203-5
ORIGINAL ARTICLE
Appraising osteoporosis care gaps Thomas P. Olenginski • Jana L. Antohe • Elaine Sunderlin • Thomas M. Harrington
Received: 14 June 2011 / Accepted: 22 October 2011 / Published online: 20 November 2011 Ó Springer-Verlag 2011
Abstract To evaluate physician response to dual-energy X-ray absorptiometry (DXA) report within the Geisinger Medical Center’s Mobile DXA Program and treatment adherence at 1 year. Between 10/01/2004 and 3/30/2005, 1381 DXA scans were performed in our Mobile DXA Program. Within this cohort, we identified 366 high-risk, drug-naive patients and report the percentage of patients placed on prescription drug therapy within 90 days of DXA result. Additionally, we identified 191 patients with Z-score of -1.0 or worse and report whether laboratory tests were ordered within 90 days of DXA results in this group. Finally, we determined treatment adherence at 1 year. 269 patients (74%) were offered prescription therapy within 3 months of DXA results. Of those, 210 (57%) were still adherent to drug therapy at 1 year. The main reason for discontinuation of treatment was an adverse drug side effect. Additionally, in 50% cases, physicians ordered 1 or more laboratory tests to evaluate low Z-score. Within our Mobile DXA Program, 74% of high-risk, drug-naı¨ve patients were treated. Interestingly, in 50% cases, when a low Z-score was reported, our physicians ordered 1 or more laboratory tests. Treatment adherence was 57% at 1 year. Keywords Osteoporosis DXA Osteoporosis care gap Fracture risk Treatment adherence Bisphosphonates Glucocorticoid induced osteoporosis program T. P. Olenginski (&) J. L. Antohe T. M. Harrington Department of Rheumatology, Geisinger Medical Center, MC 21-52, 100 North Academy Avenue, Danville, PA 17822, USA e-mail:
[email protected] E. Sunderlin Department of Internal Medicine, University of North Carolina, Chapel Hill, NC, USA
Introduction Osteoporosis remains a serious disease exacting profound physical, emotional, healthcare, and other societal costs [1]. This condition is often clinically silent, but the use of DXA testing as a risk stratification tool has become widely available. In addition to DXA, other clinical risk factors have been identified that independently increase a patient’s future fracture risk [2]. In February 2008, the National Osteoporosis Foundation (NOF) clinician’s guide to the diagnosis and treatment of osteoporosis was published and incorporated the new World Health Organization Fracture risk Assessment Tool (FRAX) methodology into clinical practice [3]. Several food and drug administration (FDA)approved drugs are available that have been shown to reduce fracture rates in clinical trials [4–12]. Despite the availability of DXA and proven treatment options, serious clinical care gaps exist and have been documented to affect the initiation of therapy as well as persistence and compliance with therapy. Thus, most patients with osteoporosis, most patients with fragility fractures, and others at serious risk may not be on therapies that have been shown to be effective at reducing complications of this disease state [13–26]. The Geisinger Health System’s Rheumatology Department is particularly committed to excellence in clinical osteoporosis care. Geisinger’s integrated healthcare delivery system, its fully integrated inpatient and outpatient electronic health record (EpicÒ), and the ability to easily communicate within are well documented. This affords us the opportunity to address certain specific issues in clinical osteoporosis care, especially known care gaps reported internationally. Uniform clinical osteoporosis care guidelines were established in 1998 and are electronically available (http://www.geisinger.org/osteo) and continue to
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be updated in an effort to ‘make it easy for our primary care physicians to do the right thing’ [27, 28]. Uniform DXA-reporting guidelines are strictly adhered to in the Department of Rheumatology’s Mobile DXA Program. Initially inaugurated in November of 2001 with its first Mobile DXA diagnostic unit, our current program includes two operational diagnostic units, two dedicated drivers, and three International Society for Clinical Densitometry (ISCD)-certified Technologists that provide diagnostic services to over 20 primary care sites within the Geisinger Health System. Our average DXA patient is 66 years old, and 1/3 patients who have a DXA are classified as highrisk, where the recommendation is made to initiation prescription osteoporosis therapy [28], based on system-driven recommendations. Given this background, and understanding the current clinical landscape, with documented care gaps, we sought to answer three simple but important clinical care questions. First, when a physician receives a DXA report, and the recommendation is made to initiate prescription therapy, how often do our Mobile DXA physician users follow the reported recommendation? Secondly, when recommendations are made to consider ordering laboratory tests in response to a low reported Z-score, how often does that happen? Finally, in those patients initiated on prescription osteoporosis therapy, what percentage of patients is still adherent to therapy at 1 year? In evaluating these questions, we attempt to improve clinical osteoporosis care within our integrated healthcare system and stimulate others to do the same.
At that time, in accord with the existing 2003 National Osteoporosis Foundation (NOF) Clinical treatment guidelines [27, 29], a patient was classified as high-risk when (a) T-score was -2.1 or worse in post-menopausal women or men over age 50; (b) T-score was -1.6 to -2.0 and one or more major clinical risk factors were present (low body weight \127 lbs, current cigarette smoker, personal osteoporotic fracture, or parental history of spine or hip fracture); (c) T-score was -1.1 or worse and patient was on chronic glucocorticoid therapy [Geisinger specific recommendation based on bisphosphonate efficacy in Glucocorticoid Induced Osteoporosis Program (GIOP)]; or (d) vertebral or hip fracture was uncovered by history, X-ray data, or vertebral fracture assessment (VFA). Such patients would have treatment recommendations uniformly made within DXA report to consider initiating prescription osteoporosis therapy (see Table 1). This study was approved by the Geisinger Health System Internal Review Board. By reviewing the electronic health record (EpicÒ), we determined whether these highrisk, drug-naı¨ve patients were initiated on drug treatment within 3 months of DXA result. Within this same cohort of patients, we also identified 191 patients who had a low Z-score reported (-1.0 or worse), where a uniform recommendation to consider performing a secondary cause bone loss evaluation was made in DXA report and the physician was directed to a smart set link in EpicÒ that outlined a series of tests to consider. Finally, we determined the percentage of patients’ adherent to drug therapy at 1 year and attempted to identify the reasons for discontinuation of treatment by querying office visits, telephone encounters, patient calls, etc. within EpicÒ.
Methods Between 10/01/2004 and 3/30/2005, 1381 DXA scans were performed in our Mobile DXA Program. DXAs were interpreted by one of the 3 ISCD-certified densitometrists. Interpretations strictly adhered to the DXA-reporting guidelines recommended by the ISCD and were clinically driven and linked to existing Osteoporosis Clinical Care Guidelines (http://www.geisinger.org/osteo).
Results Three hundred and thirty-three patients were identified as high-risk and drug-naı¨ve in this cohort. Our analysis revealed that 269 patients (74%) were prescribed osteoporosis therapy within 3 months of DXA result (see Table 2).
Table 1 Uniform DXA reporting for high-risk patients Post-menopausal woman
Treatment with a bisphosphonate (such as alendronate, risedronate, or ibandronate) should be considered. If the patient is unable to use an oral bisphosphonate, another agent such as IV bisphosphonates (ibandronate or zoledronic acid), teriparatide, or a selective estrogen receptor modulator (raloxifene) should be considered
Man 50 and older
Treatment with a bisphosphonate (such as alendronate, risedronate, or ibandronate) should be considered. If the patient is unable to use an oral bisphosphonate, another agent such as IV bisphosphonates (ibandronate or zoledronic acid) and teriparatide should be considered
GIOP
In this individual on glucocorticoids, treatment with a bisphosphonate (such as alendronate, risedronate, or ibandronate) should be considered. If the patient is unable to use an oral bisphosphonate, another agent such as IV bisphosphonates (ibandronate or zoledronic acid), teriparatide, or a selective estrogen receptor modulator (in a woman, off label usage) should be considered
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Table 2 Breakdown of high-risk, drug-naı¨ve patients who received prescription 366 high-risk patients 269 patients started treatment within 90 days 156 patients were on same treatment at 1 year
13 patients started treatment after 90 days
43 patients switched to different treatment
69 patients stopped treatment
11 patients on same treatment at 1 year
2 patients stopped treatment
210 patients were on any FDA-approved medication at 1 year
Table 3 Uniform DXA reporting for low Z-score Uniform DXA reporting for low Z-score
Given the patient’s Z-score (comparison with age-matched controls) that is \-1.0, one should consider secondary causes of low bone mineral density. Studies to consider would include 25-OH vitamin D, CBC, comprehensive metabolic panel, phosphorus, TSH, ESR, PTH, spot urine for hypercalciuria, and testosterone (men only). For EpicÒ providers, use the OSTEOPOROSIS Smart Set [1146]
Hundred and fifty-six of the original group of 269 patients (58%) who began prescription therapy were continuing on therapy at 1 year. Hundred and twelve patients (42%) stopped their prescription therapy, and 1 patient was lost to follow-up (see Table 2). Forty-three of the original 269 treated patients stopped their medication but were switched to alternate prescription osteoporosis treatment. Thus, 199 of the initial 269 treated patients (74%) were adherent to prescription osteoporosis therapy at 1 year. Finally, we identified 13 additional patients who were started on prescription therapy after 3 months of reported DXA results; however, these patients were classified as non-adherent based on our definition. While there is no published consensus guide on a formal evaluation for secondary causes of osteoporosis, we report low Z-scores when -1.0 or less in our DXA-reporting format. In our DXA reports, uniform language is employed to alert ordering physician to this (Table 3). We identified that 50% of patients with a reported low Z-score result in DXA report had one or more laboratory tests ordered in response to the DXA report recommendation (Table 4). Table 5 shows a breakdown of the tests performed by our Table 4 Tests ordered for secondary causes of bone loss Test performed
# performed
% of tests
25-OH Vit. D
81
79.41
I-PTH
76
74.51
TSH
76
74.51
Calcium
73
71.57
Alkaline phosphatase
69
67.65
Phosphorus
58
56.86
Hb/Hct
70
68.63
7
43.75
Free testosterone (men) IEP
7
6.86
Quantitative IG
5
4.9
physicians in evaluating for possible secondary causes of bone loss. Vitamin D deficiency was the most common secondary cause tested for in this group of patients. Importantly, in 73% of cases, the vitamin D (25-hydroxyvitamin D) level was low or inadequate, prompting the physician to act on the low vitamin D result (operationally, vitamin D insufficiency was defined as levels \30 ng/ml for the purposes of this study).
Discussion Osteoporosis clinical care gaps have been identified and reported both here in America as well as internationally [13]. These care gaps include failure to identify high-risk patients, failure to adequately utilize DXA, failure to initiate prescription therapy in appropriate patients, including those with documented fragility fractures, failure to document fractures, etc. [14–26]. In a comprehensive review in a registry of capitated prescription plans, Solomon et al. estimated that only 20–30% of high-risk patients were treated with prescription therapy. Others have reported such inadequate treatment rates [16–19, 22–26]. While problems with drug initiation remain, ongoing adherence and compliance with recommended therapy remains an additional clinical challenge. Studies have documented such adherence problems, especially with oral bisphosphonates [31]. From an integrated healthcare standpoint, the challenge then is not only appropriate initiation of fracture-reducing therapies in the right group of patients, but vigilance and attention to the likelihood that patients may discontinue prescribed therapies. Two intravenous (ibandronate and zoledronic acid) and two subcutaneous FDA-approved therapy exist (teriparatide and denosumab). Such treatment options should stimulate further attention to the important compliance and adherence issues that affect clinical care.
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3622 Table 5 Results of tests ordered for secondary causes of bone loss
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Test
% of tests
Abn. value
% time abnormal
25-OH Vit. D
79.41
21.69
\30
72.8
I-PTH
74.51
35.03
[40
27.6
TSH
74.51
2.25
\0.5
2.9
Testo, free (men)
43.75
8.74
\5.6
42.9
A
14.3
IEP
6.86
Within our health system, we have tried to be attentive to these gaps in osteoporosis care. In 1998, a published set of Clinical Osteoporosis Clinical Care Guidelines was adopted [27], became available in print, and was available on our intranet (http://www.geisinger.org/professionals/ services/osteo/index.html). Importantly, uniform DXAreporting guidelines were adopted with creation of a Geisinger Health System DXA Work Group, with an administrative as well as clinical group of participants. This group encompassed all the available clinically active DXA centers within the entire Geisinger Health System. DXA-reporting standards were adopted to ensure uniform ‘clinical-reporting’. When a ‘high-risk’ patient is classified in a DXA report, the specific language in the report is uniformly the same and all aspects of DXA interpretation are clinically consistent with the ISCD recommendations [32]. VFA technology and reporting have been uniformly integrated within all DXA centers as well [33]. Given this, we had never systematically studied whether our DXA physician users followed the DXA report recommendations, whether a secondary bone loss evaluation was pursued, or whether patients adhered to initiated osteoporosis medications. Geisinger’s Rheumatology Department and Mobile DXA Program have led these efforts. While Mobile DXA Program physician users became increasingly comfortable with the DXA-reporting format, clinical care guidelines, and intranet linkage, it remained important to study their practice patterns after receiving our DXA reports. Previous literature indicated that recipients of clinical DXA reports ordered more DXA scans, but we were unaware of studies examining whether appropriate clinical care was rendered after DXA results were received [34]. As described in our results, we determined that appropriate prescription therapy was started within 90 days of DXA result in 74% of highrisk, drug-naı¨ve patients. This figure is markedly superior to the treatment rate described by Solomon et al. [30], where only 20–30% of high-risk patients were prescribed medications. Reasons for our high prescription therapy use include (a) familiarity with DXA-reporting format, (b) uniformity of DXA reporting in Mobile DXA Program (then, 3 ISCD-certified densitometrists), (c) availability of clinical care guidelines, both published and web-based,
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Mean value
(d) Medical Grand Rounds dedicated to Osteoporosis care over study period, (e) accessibility of communicating with densitometrists by staff messaging within EpicÒ, etc. While this was not formally studied, our Mobile DXA users repeatedly emphasized these messages of success to us on a consistent basis. Uniformly, when DXA scan includes a Z-score of -1.0 at any skeletal site, this is included in DXA report, along with consistent language to ‘consider secondary causes of bone calcium loss’ (see Table 3). Likewise, within the DXA report, there is a reminder that an osteoporosis smart set can be accessed, where an easily accessible EHR section highlights available tests to order [comprehensive metabolic panel, complete blood count with differential (CBC), sedimentation rate (ESR), phosphorus, 25-hydroxyvitamin D, intact-parathyroid hormone (PTH), thyroidstimulating hormone (TSH), immune electrophoresis (IEP), quantitative immunoglobulins, testosterone, random urine for calcium and creatinine to estimate 24-h urinary calcium excretion, endomysial and gliadin antibodies). In response to the recommendation to consider one or more of these tests, when Z-score of -1.0 or worse was reported, in 50% of patients, our DXA physician users ordered 1 or more such laboratory tests. While we are unaware of any publication offering a consensus statement on this clinical practice, some interesting observations emerged [35]. The most common laboratory test ordered was a 25-hydroxyvitamin D level. In 73% of ordered vitamin D levels, the result identified vitamin D insufficiency (25-hydroxyvitamin D level \30 ng/ml), where specific clinical attention and intervention were necessary. These findings reemphasized the documented clinical importance of vitamin D deficiency [36]. Most importantly, our Mobile DXA physician users have applied clinical care that favorably affects day to day osteoporosis care. After the study results on vitamin D testing were known, we have addended our DXA reports to more pro-actively consider vitamin D testing, even in the absence of low reported Z-scores. Similar to other reports on drug adherence in an osteoporotic population, we document that only 57% patients remain on drug at 1 year [31]. Fortunately, we determined that some patients who stopped drug were reinitiated on alternate prescription therapy, and a small percentage of
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patients were initiated on therapy after 3 months post-DXA results. Identified reasons for stopping therapy were side effects (especially gastrointestinal), cost constraints, and others. Unfortunately, it was very difficult to identify more specific reasons for stopping prescription therapy in our retrospective study and EHR chart queries. Specific attention and scrutiny for the patient likely to stop medication in clinical osteoporosis care today cannot be overemphasized. Newman et al. [37] report [90% drug adherence rate in a specialized pathway of care they termed GIOP in the Geisinger Health System. This program aimed to educate patients regarding the adverse bone health risks of chronic glucocorticoid therapy, measure patient education retention, and closely monitor bone health within that population. Reasons to explain the success reported included the scheduled follow-up care visits (baseline, at 6 months and at 1 year) and phone call contact to assess adherence and query for possible side effects related to prescribed medications. Appreciating the known problem of treatment discontinuation rates in osteoporosis care, individual practitioners, integrated health systems, and others are challenged to better study and address solutions to this adherence problem in everyday osteoporosis care, apart from the GIOP population. In conclusion, 74% of drug-naı¨ve, high-risk patients were prescribed osteoporosis medication within 90 days of DXA report in our Mobile DXA Program. While we are encouraged by the results of our study, we are not satisfied and aim to reach better drug therapy initiation rates, achieve better adherence, etc. Hopefully, similar studies and subsequent findings will prompt changes in healthcare delivery that effectively influence the clinical care of osteoporosis. Conflict of interest of interest.
The authors declare that they have no conflict
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