Arch Osteoporos (2015) 10: 24 DOI 10.1007/s11657-015-0222-7
ORIGINAL ARTICLE
Swedish osteoporosis care Emma Jonsson 1 & Daniel Eriksson 1 & Kristina Åkesson 2 & Östen Ljunggren 3 & Stina Salomonsson 4,5 & Fredrik Borgström 1,6 & Oskar Ström 1,6
Received: 11 February 2015 / Accepted: 27 May 2015 / Published online: 11 August 2015 # International Osteoporosis Foundation and National Osteoporosis Foundation 2015
Summary Mini-abstract The objective of this study was to review and describe the current state of Swedish osteoporosis care and to highlight ongoing challenges. This report encompasses quantitative health outcomes based on Swedish registry data as well as organizational and management aspects. Executive summary Swedish osteoporosis care is characterized by a significant burden of disease, difficulties in identifying high-risk patients, and fragmented pathways for patients in need of secondary fracture prevention. This report aimed to describe the current state, gaps, and challenges in Swedish osteoporosis care, using Swedish national databases, questionnaires, and interviews with healthcare representatives. A secondary aim was to develop quality and process measures to compare differences between counties and to use those measures to describe the interaction between quantitative health outcomes and aspects of care organization and management. In conjunction with fractures, a considerably smaller proportion of men are treated than women, and a smaller proportion of older women are treated compared to younger groups.
Between 3 and 16 % of patients receive treatment after a fracture, and the treatment rate in this patient group can likely increase. In addition to an unsatisfactory treatment rate, a limited number of those treated continue treatment throughout the recommended treatment durations, leading to increased risk of fracture. With a substantial variation between counties, there is a clear difficulty to identify non-persistent patients and switch to an alternative treatment. Collaboration around the patient across specialties has been lacking, and systems for secondary prevention have been concentrated to a few counties. However, when this study was conducted, there was a general trend towards implementing regional care programs. This report suggests possible strategies for improving quality of care and, hopefully, it can provide a basis for future evaluations and regional improvement of osteoporosis care in Sweden and other countries. Keywords Fracture . Osteoporosis . Sweden . Treatment patterns
Introduction * Oskar Ström
[email protected] 1
Quantify Research, Hantverkargatan 8, 112 21 Stockholm, Sweden
2
Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
3
Department of Medical Sciences, Uppsala University, Uppsala, Sweden
4
Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden
5
Merck Sharp & Dohme (Sweden), Sollentuna, Sweden
6
LIME/MMC, Karolinska Institutet, Stockholm, Sweden
Background Swedish women are among those at the highest risk of suffering from a fracture when compared at a global level. Each year, thousands of fractures occur because many people remain untreated for osteoporosis while at the same time many undergoing treatment do not continue throughout the recommended treatment duration. There is a broad consensus in the scientific literature that osteoporosis is under-prioritized and under-treated in most industrialized countries [1]. This is also in line with the National Board of Health and Welfare’s recommendation of a fivefold increase in the proportion of
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patients treated [2]. Efforts to reduce this Bcare gap^ can be a cost-effective and important investment that may contribute to better health in an aging population and thereby to the societal economy [3]. A recent international comparison has shown that Sweden is one of the better countries in Europe when it comes to providing coordinated fracture liaison services to case-find patients with bone fragility who have suffered a fracture (i.e., at least 10 % of all Swedish hospitals having a scheme that refers fracture patients over 50 years of age to a BFracture Liaison Service^ with the aim to case-find osteoporotic fracture patients) [4]. However, the provision of fracture liaison services was shown to be distributed unevenly throughout the country. At the same time, when it comes to the difference between the number of people treated with osteoporosis medication and the number of people at high risk of suffering an osteoporotic fracture, the comparison shows that Sweden has the ninth highest difference in Europe. In other words, there is a lot of work left to do. A number of factors contribute to the under-diagnosis of osteoporosis and poor treatment adherence. An earlier study in this area has shown that these factors include the following [5]: & & & &
The asymptomatic nature of the disease Concerns about polypharmacy among patients who may be in need of preventive treatment Costs and time required for investigation and diagnosis The lack of clarity regarding the clinical division of responsibility in relation to the disease
The lack of clarity regarding division of responsibility, for example, means that few patients come to clinical attention by evaluation of risk factors. There are, however, differences between different counties and regions in Sweden when it comes to the quality and efficiency of osteoporosis care. The report Quality and Efficiency in Swedish Healthcare has spread knowledge about regional differences in the ability to identify patients in conjunction with an osteoporotic fracture and offer prevention against additional fractures [6]. The proportion of women who receive preventive treatment within 6 to 12 months of a fracture varies between 8 and 24 %, depending on county. An important step towards improvements in osteoporosis care is to eliminate unjustifiable differences and thereby make it more equal. Equality in care is about making access to healthcare equal regardless of where the patient resides and ensuring that the condition is not forgotten for some other unjustifiable reason. Comparisons, which serve to highlight and assess differences in healthcare, can be a tool to drive quality development forward. However, at a national level, the quality indicator in Quality and Efficiency in Swedish Healthcare shows no improvement since 2010. Further analysis is likely required to find and understand the underlying reasons for the differences and determine what is required to achieve a general
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improvement in quality. The National Board of Health and Welfare’s national guidelines for musculoskeletal conditions were published in 2012. The guidelines intended to support prioritization and the use of scientifically evaluated methods. It is widely accepted that healthcare should be based on the best available scientific evidence. The guidelines hopefully serve as a starting point towards higher quality and more equal osteoporosis care. Purpose and outline The current situation (BOsteoporosis^ and BThe current state of Swedish osteoporosis care^ sections) One purpose of this report is to provide a description of the current state of Swedish osteoporosis care. The description provides an objective survey of the current state of Swedish osteoporosis care and tries to describe what gaps exist. Regional comparisons (BTreatment pathway of the osteoporosis patient,^ BTreatment patterns,^ and BHow are the osteoporosis guidelines being implemented in the Swedish healthcare sector?^ sections) A secondary purpose of the study is to develop a number of different quality and process measures that can be used to compare differences between counties and regions. Through the measures, various perspectives of osteoporosis care are gathered, making is possible to analyze which strategies are currently used and what could be done in the healthcare sector to improve the prevention of osteoporotic fractures. The study summarizes the correlation between quantitative health results and aspects of care organization and management along with how these factors indicate quality and effectiveness in Swedish osteoporosis care. Knowledge base (BThe current state of Swedish osteoporosis care,^ BTreatment pathway of the osteoporosis patient,^ BTreatment patterns,^ and BHow are the osteoporosis guidelines being implemented in the Swedish healthcare sector?^ sections) Thirdly, the report can hopefully provide practical information for ongoing improvement work. In many areas of the country, efforts are underway or are being planned for osteoporosis care based on the National Board of Health and Welfare’s guidelines. We believe there is an interest in seeing what is being done and what works in different parts of the country to improve and integrate care pathways. We hope that this survey can contribute to a discussion on how osteoporosis care can be further improved and that the quality and process measures that have been presented can be reapplied in future evaluations.
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This report is aimed to healthcare providers, the public, as well as decision-makers. It is divided into six sections:
to the county or region level. The term Blocal^ refers to the operational level.
Osteoporosis This section provides an introduction to the disease and its epidemiology.
Registry data
The current state of Swedish osteoporosis care This section aims to create a general picture of the level of quality and effectiveness in Swedish osteoporosis care. The description is done with the help of various measures, based on analysis of registry data, published literature, and the report Quality and Efficiency in Swedish Healthcare. Treatment pathway of the osteoporosis patient This describes various organizational aspects of osteoporosis care, what systematic methods are used to identify at-risk patients, and what risk profiles the various counties target when it comes to preventive interventions. The analyses in this section are primarily based on interviews with county representatives and registry data. Treatment patterns Various fracture and medication-related results, which are significant for effective fracture prevention, are described by a number of quality and process measures. These measures are based on detailed analysis of Swedish registry data. How are the osteoporosis guidelines being implemented in the Swedish healthcare sector? This describes how various counties and regions in Sweden are currently working to implement the National Board of Health and Welfare’s national guidelines for musculoskeletal diseases and to improve osteoporosis care. This review is based on interviews with county representatives. Discussion This section provides the work team’s assessment of what is being done and what could be done in the Swedish healthcare sector to prevent osteoporotic fractures.
Data and methodology This study is based on registry-based data from the Swedish Prescribed Drug Register and the National Patient Register as well as interview and questionnaire data from representatives of care providers and counties. Where the source in figures and tables is specified as Bown analysis,^ this refers to our processing of data from these data sources. The study was granted ethical approval by the Regional Ethics Review Board in Stockholm (reg. no. 2013/607-31/5). For simplicity, regions and counties will be collectively referred to as counties in this report. The term Bregional^ in this report refers
From the registries, we identified women and men 50 years of age and older with at least one filled prescription for osteoporosis medication or a registered fracture from 1 January 2007 to 31 December 2011. The research database comprised 243, 000 individuals with a major osteoporotic fracture and 179, 000 individuals with a prescription of osteoporosis medication. Approximately 10 % had records of both a fracture and osteoporosis medication. Data regarding diagnoses and medication were linked to the cause-of-death register. For definitions, diagnosis, and medication codes, see the Appendix. Questionnaire and interview data Information related to the organizational questions was obtained through interviews and questionnaires with representatives from major stakeholders of the osteoporosis care sector in Sweden’s 21 counties and regions. These consisted of 76 representatives from orthopedic clinics, osteoporosis centers, primary care, and healthcare administrations responsible for evidence-based management and development issues as well as osteoporosis care expert groups. Interviews and questionnaire collection were carried out during the spring and fall of 2013. All participants were given the opportunity to review the data.
Results Osteoporosis This section provides an introduction to the disease osteoporosis. The section describes the epidemiology, definition of osteoporosis-related fracture, available treatment options, and consequences and societal costs related to osteoporosisrelated fractures. Figure 1 provides a general description of Swedish osteoporosis care. Summary &
&
For a 70-year old Swedish woman with a prior fracture, the 10-year probability of suffering a major osteoporotic fracture or hip fracture is 26 and 9 %, respectively. Sweden has one of the highest fracture risk levels in the world. The incidence of hip fractures dropped between 2007 and 2011. The greatest change (minus 9 %) occurred in women in the age groups 50 to 64 years and 80 years and older.
24 Page 4 of 41 Fig. 1 Swedish osteoporosis care: overview. The five diagrams below provide key indicators that provide a general description of Swedish osteoporosis care. The key indicators are our own analyses of data collected from the national pharmaceutical registry and patient registry
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1. Major osteoporotic fractures
2. Medicine prescriptions filled at the pharmacy
Distribution of fracture type in women and men in Sweden, 2011, N=63,527
Proportion of osteoporosis-indicated medication in Sweden, 2011, N=103,895
Denosumab 2% Other 3% Zoledronic acid 3%
Vertebra 5%
Raloxifene 2%
Other 18% Hip 29%
Risedronic acid 12% Shoulder and upper arm 18%
Forearm 30%
Alendronic acid 78%
4. Osteoporosis risk factors
3. Fracture and medication in men
Proportion of women and men with any risk factor upon first filling of prescription for some type of osteoporosis medication (index-date), 2011, N=19,814
Proportion of all fractures and pharmaceutical treatments in men, 2011, N=172,097
45 40 35 30 25 20 15 10 5 0
45 40 35 30 25 20 15 10 5 0
29%
13%
Fracture
42% 37% 24%
Older than 75 Prior fracture Glucocorticoids
Medication
5. Age during treatment with alendronic acid Distribution of age at first filling of alendronic acid prescription at pharmacy over 2 years, 2007 to 2011, N=83,053
50
55
60
65
70
75
80
85
90
95
100 Age
1, 2, 3, 4, 5:Regards patients age 50 and older with at least one treatment or fracture type. Medication: ATC G03XC01, H05AA02, H05AA03, M05BA, M05BB, M05BX03, M05BX04. Fracture diagnoses: ICD 10 S32.1-8, S52.5-6, S42.2-3, S72.04, S22, S82.1. Regards both inpatients and outpatient specialist care. 1. ICD 10 S22.x, S32.1-S32.8. 2. Zoledronic acid only regards prescriptions filled at a pharmacy. 4. Proportion of patients with at least one filled prescription of glucocorticoid medication in tablet form, 12 months prior to index date. Proportion with prior fracture within last five years of index date 5. ATC M05BA04.
& & &
Almost one third of all men and 15 % of all women over the age of 85 die within 3 months of suffering a hip fracture. The annual cost for fractures among the elderly was estimated at SEK 12.5 billion in 2010. Among sold osteoporosis medications, the proportion of alendronic acid has increased since 2007 at pace with the price decrease for the medication. In 2011, alendronic acid
&
accounted for approximately 80 % of all osteoporosis medication prescriptions filled via pharmacy. Osteoporosis has traditionally been diagnosed with bone mineral density scan and by evaluating risk factors. The World Health Organization’s (WHO) web-based risk assessment tool (FRAX) is also used to facilitate assessment when there are several risk factors interacting and to simplify communication of fracture risk to patients.
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Introduction to osteoporosis Bone is a living tissue that changes throughout a person’s lifetime. The skeleton is in a state of continual transformation as old and unneeded bone tissue is broken down and new tissue is created. The breakdown process is called bone resorption and is handled by cells called osteoclasts. The building process, which is known as bone formation, is handled by cells called osteoblasts. Bone mass grows in strength from the time we are born up until about 20 to 30 years of age, when bone tissue is at its greatest mass and quality. When we get older, the growth of new bone cells slows down and bone quality deteriorates. If cells break down at a faster pace than new ones are formed, the bones can become porous and the risk of fracture increases. Osteoporosis, Bporous bone,^ is a disease characterized by reduced bone mass and bone structure deterioration, leading to reduced strength and an increased risk of fracture [7]. The diagnosis was defined in 1994 by the WHO based on dual-energy X-ray absorptiometry (DXA) of the bone mineral density (BMD). According to WHO’s criteria, osteoporosis is defined as a BMD of at least 2.5 standard deviations (SD) below the mean for young adults. Osteopenia can be a precursor to osteoporosis and is defined as a BMD of between 1 and 2.5 standard deviations below the mean for young adults. The WHO’s diagnosis criteria are presented in Table 1. Osteopenia is not defined as a disease, but identifying patients with osteopenia makes it possible to capture the majority of those who develop osteoporosis within the next 10 years [3]. The clinical consequence of osteoporosis is fractures caused by bone fragility. A person with osteoporosis does seldom experience any symptoms prior to the fracture that would indicate that bone quality has deteriorated. The fractures that occur are often the result of low-energy trauma, like a fall from a standing height or other mild trauma that would not cause a fracture in a person with normal bone density. The most common osteoporosis-related fractures occur in the hip, forearm, proximal humerus, and vertebrae in the spine. Not all fractures are associated with osteoporosis. This applies to fracture types whose risk does not increase with age and that do not respond to osteoporosis treatment. These include fractures to the hand, foot, ankle, fingers, toes, and skull. Table 1
Declining estrogen levels after menopause cause bone mass to deteriorate more quickly in women than in men. Thus, postmenopausal women are more likely to suffer from bone fragility. Bone density is 12 to 25 % higher in men, depending where in the skeleton bone density is measured [9]. This contributes to a lower fracture incidence in men. Postmenopausal osteoporosis is defined as primary osteoporosis. Other diseases or pharmaceutical treatments can also cause the disease. In such cases, it is defined as secondary osteoporosis. Glucocorticoids (cortisone-like medication), aromatase inhibitors against breast cancer, and castration treatment for prostate cancer are examples of treatments that can cause bones to become fragile. Secondary osteoporosis can be significantly improved through treatment of the underlying cause of the disease. It is therefore important to distinguish whether osteoporosis is due to age-related factors or other diseases and medications. Other risk factors for osteoporotic fracture are as follows: & & & & & & & & &
History of fragility fracture Low body mass index (−1.0) BMD between 1 and 2.5 SD below the mean for young adults in the same population (−2.516 individuals/1,000 residents (best county average)
The target levels are adjusted once per year, and the calculation is standardized by age for comparison between counties and for follow-up within the county. Educational activities Another important measure to introduce new evidence-based material is to spread information through methods such as seminars and lectures. Ongoing education in osteoporosis treatment for healthcare personnel, e.g., updating of treatment alternatives and effective ways to treat and monitor secondary causes, is necessary and should be offered [40]. All counties have indicated that some form of osteoporosisrelated training aimed at primary care physicians has been or is planned to be held. The courses have focused on new treatment recommendations and guidelines. A number of counties indicated that training was arranged in conjunction with implementation of new osteoporosis guidelines in organizations. & & & &
& & &
In Skåne, Sörmland, Östergötland, and Västerbotten, osteoporosis therapy and expert groups have arranged courses aimed at primary care or hospital physicians. Västernorrland, Dalarna, Skåne, and Uppsala have or are planning special training to introduce new osteoporosis guidelines. In Västerbotten, Västra Götaland, Stockholm, and Östergötland, osteoporosis-related courses have been held regularly or on several occasions over the course of the years. In Västerbotten, an osteoporosis expert group invites physicians to lunch lectures each year to communicate new recommendations. They also occasionally hold half-day courses on osteoporosis aimed to physicians. In Västra Götaland and Blekinge, osteoporosis-related courses have been held regularly, including in conjunction with the development of new regional guidelines. Kronoberg, Dalarna, Jämtland, Västernorrland, and Norrbotten provided targeted information on national guidelines. In Värmland and Östergötland, osteoporosis is part of a general education program, which has been organized on several occasions. Gävleborg, for example, invited primary care physicians to osteoporosis-related training in autumn 2013.
Quality assessment: implementation and evaluation of compliance to guidelines To describe how different counties work and have worked to introduce osteoporosis guidelines after
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Accordingly, 14 counties were ranked in the dark blue quality category, and seven were ranked in the light blue quality category. No county ended up in the grey category since all counties have plans to improve osteoporosis care or have already introduced improvements (according to the responses received from various representatives). We consider it a shortcoming, however, that only a few counties plan to assess quality development in their own care process and instead choose only to follow the results that the National Board of Health and Welfare present in Quality and Efficiency in Swedish Healthcare. It could be beneficial to perform a more thorough evaluation at the organization level to achieve quality improvements in the future.
Discussion
Fig. 30 Criteria for the work group’s quality assessment: implementation and compliance to guidelines
publication of the national guidelines, the report writers have defined three quality criteria. Figure 30 describes the criteria used as the basis for the assessment, and Table 9 presents the results together with a summary of the factors that form the basis of each county’s assessment. The quality assessment criteria are based on what work is being done or planned to identify where in the care process quality is lacking, what action is being taken to improve quality, and how the development of quality of care and health outcome is monitored at the regional level. The quality assessment is generally based on whether osteoporosis care is prioritized in the counties. To receive the highest grade (dark blue), some type of follow-up of quality and results in the organization must have been performed for the entire care process. Improvement measures must be in place or planned, and there must be a plan for follow-up of quality and results. For the middle grade (light blue), similar criteria apply, but there is no ready-made or selfmade plan for following up results and quality. For the grey level, none of these activities have been carried out. The results indicate that there is generally a good process for implementing the national guidelines for osteoporosis. This is likely because most counties have incorporated processes for evidence-based management processes and have thereby organized implementation of guidelines and other evidence-based support.
In this report, we described the current state of Swedish osteoporosis care. Differences between Swedish counties have been highlighted through a number of quality and process measures related to care organization, management, and treatment patterns. For example, the measures show aspects of the care organization, which over time may affect the ability to prevent osteoporotic fractures along with the consequences for health outcome and costs. By highlighting quality differences and good examples, this report can hopefully contribute to a discussion on how osteoporosis care can be further improved. Description of current situation Quality and Efficiency in Swedish Healthcare’s quality indicator is an official analysis of the quality of osteoporosis care in the Swedish counties. The intention behind such official comparisons is to serve as a catalyst for identifying outcome differences between units and organizations and to assess possible causes. However, there has been no improvement at the national level during the years the osteoporosis indicator has been presented. In this report, we have tried to provide a more in-depth look at the healthcare sector and the regional differences in order to obtain better data to analyze how improvements can be made. The results show that male osteoporosis, an aspect missing in Quality and Efficiency in Swedish Healthcare, is much more under-prioritized than is the case for female osteoporosis. The proportion treated after a fracture in older patient groups is lower compared to younger patient groups where the fracture risk is relatively lower. With the incidence of this disease and the significantly
Arch Osteoporos (2015) 10: 24 Table 9
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Results of quality assessment: implementation and compliance to guidelines
Stockholm
Stockholm County Council has focused on training healthcare professionals in fracture prevention. A project is also underway to develop quality indicator similar to the one used in Quality and Efficiency in Swedish Healthcare but with follow-up at the municipal level.
Uppsala
The county has financed introduction of a new osteoporosis guideline, which is currently being designed and will be communicated to primary care. The implementation will also include a plan for monitoring compliance to guidelines, but at the time of the investigation it was unclear how this would be done.
Sörmland
A development project of the care pathway in the county is underway. At the time of the investigation, there was no plan for follow-up of results.
Östergötland
Through a joint effort by Jönköping and Kalmar, a regional medical program group follows and checks how routines and guidelines function in the county. The clinics write a quality report, which follows the prescription of osteoporosis medication. There are also plans to monitor compliance to guidelines on primary fracture prevention.
Jönköping
A medical program group conducts monitoring of routines in the county. Current improvement measures have been identified and undertaken at different hospitals, and the osteoporosis guideline has been updated as a result of the national guidelines.
Kronoberg
In conjunction with publication of the national guidelines, the county began implementation work with the introduction of a system for secondary prevention and fracture prevention training targeted to healthcare professionals. An expert group on bone fragility and fall prevention shall follow up fracture incidence and prescription of medication.
Kalmar
Kalmar has an evidence-based management organization where regional medical program groups work with guidelines. The regional medical program group for orthopedics /osteoporosis monitors and controls the routines and guidelines in the county. Kalmar also has a representative from primary care who is responsible for following up the results of the Quality and Efficiency in Swedish Healthcare indicator and for drafting an action plan for any improvement measures.
Gotland In Gotland, a project is underway to improve osteoporosis care, and two deficiencies have been identified – the treatment pathway and access to bone density measurements. Measures were planned to be introduced during 2013/2014. At the time of the investigation, there were no plans to monitor the quality of osteoporosis care. Blekinge
The county's osteoporosis guideline was updated in 2011 and is considered by the county to be in line with the national guidelines. The county administrative board does not conduct monitoring of compliance to guidelines.
Skåne
Region Skåne has an osteoporosis expert group which in 2013/2014 will draft a regional osteoporosis guideline with a regional Fracture Liaison Service, with local applications. All orthopedic clinics in the region have been allocated extra resources to establish a fracture coordinator in 2014. Funds have also been allocated for implementation and training within the framework of the osteoporosis guideline. A local quality registry shall be established in order to follow a number of quality indicators for osteoporosis care.
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Halland
Region Halland does not have an evidence-based management organization, but various organizations have their own projects to improve osteoporosis care and perform follow-ups. Staff at the orthopedic clinic have initiated improvement of the care pathway and evaluates the established routines for risk assessment of patients with fragility fractures. There is no regional follow-up of the quality of osteoporosis care or compliance to guideline.
Västra Götaland
Västra Götaland is applying a systematic approach to implementation of the national guidelines. The region finances additional costs for implementing guidelines, and three times a year administrations are compensated based on number of DXA measurements and medications prescribed. The results are presented in annual reports. Other quality indicators related to the number of osteoporotic fractures are also monitored. The regional commission has also led to various follow-up assignments, such as introducing a regional osteoporosis guideline with system for secondary prevention for secondary prevention. Discussions are underway as to how the county can improve osteoporosis care through measures such as introducing different systems for secondary prevention. There are no plans to monitor any results.
Värmland
Örebro
When the national guidelines were published, a care gap analysis was conducted and then compared in a regional seminar. Among other things, the county has had an osteoporosis guideline and system for secondary prevention for secondary prevention in place since 2011. At the time of the investigation, there were no own plans for monitoring the results beyond following the National Board of Health and Welfare's evaluations.
Västmanland
In conjunction with the publication of the national guidelines, a care gap analysis was performed. This led to the county council allocating resources to make improvements in the care process. An analysis group shall evaluate compliance to the guidelines and orthopedics will likely conduct monitoring of the number of patient referrals for investigation after osteoporotic fracture.
Dalarna
Dalarna performed a gap analysis when the national guidelines were published. Based on the analysis, a mission statement was drafted for the different aspects of musculoskeletal diseases. This includes a description of the guidelines and what must be done in the county to implement them. The concerned organizations were tasked with implementing the methods specified and monitoring the results.
Gävleborg A work group is working to develop an osteoporosis guideline and to introduce routines for secondary prevention. The county council has allocated resources, particularly to increase prescription of medication. The county council follows the prescription of osteoporosis medication through interim reports. Västernorrland
Västernorrland has an evidence-based management organization that consists of a steering committee and a work group. In 2013, the work group worked to develop an “osteoporosis treatment line”, which is intended to describe responsibilities within primary care and hospital care. A training program directed to healthcare professionals is planned in order to introduce the new treatment line. The county council has a model for pay-for-performance in relation to prescription of osteoporosis medication in primary care.
Jämtland The county council plans to improve osteoporosis care by introducing a system for secondary prevention for secondary prevention. At the time of the investigation, there were no plans to monitor compliance to guidelines. Västerbotten
In conjunction with publication of the national guidelines, a gap analysis was performed to study the difference between the guidelines and the current situation in the county. During 2013/2014, work is in progress to improve the areas highlighted during the inventory of the current situation. At the time of the investigation, there were no plans to monitor compliance to guidelines.
Norrbotten
Norrbotten has an expert group for musculoskeletal diseases that works to receive guidelines, analyze the guidelines in relation to current practice and develop recommendations. A project is underway to improve the areas identified as deficient. There are plans to introduce “internal controls” to evaluate osteoporosis treatment patterns.
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higher fracture risk among the elderly, it is desirable to improve diagnostics in this group.
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&
Differences between counties & The work to improve osteoporosis care throughout the country faces clear challenges. Different local conditions and heterogeneous populations may likely contribute to overall differences between counties. For example, it may be difficult for a large region to unify all healthcare units with the same strategies and goals, and heterogeneous populations could make it difficult to get different aspects of osteoporosis care to work on a broad front. Integrated processes for secondary prevention to capture all types of osteoporotic fractures may lead to an increased proportion of patients receiving secondary preventive treatment. However, it is unclear whether different ways of organizing the system or system for secondary prevention would lead to better results, since conditions differ between the various counties and areas. It is also unclear whether the introduction of systems for secondary prevention will over time make it possible to achieve the National Board of Health and Welfare’s target of 60 to 70 % treated after a fracture. Possible strategies In response to the publication of the national guidelines and previously reported quality differences, such as those reported in Quality and Efficiency in Swedish Healthcare, counties have been required to analyze what is causing the quality differences and to rectify problems identified in the care process. Systems for secondary fracture prevention have been a prioritized measure in all of the counties. Such care pathways require systematic routines in units that take care of osteoporosis-related fractures. The routines must ensure extensive identification and investigation of underlying risk factors and must provide timely intervention and patient follow-up. The national guidelines have set clinical decision-making rules for investigation and treatment. However, the national guidelines have a low degree of control in the healthcare sector, and it is up to the regional healthcare systems to implement them. Guidelines alone are probably not enough to create routines. They must be anchored locally in the organizations. The goal should be better equality in osteoporosis care and the prevention of additional osteoporotic fractures among the population. The opinion of the work group is that a number of conditions should be fulfilled to be able to eliminate unjustified differences in care:
Decision-makers must support work to eliminate quality deficiencies by allocating resources and establishing routines, in order to identify and adjust deficiencies in the local care process. There must be strategies for systematic monitoring of compliance to guidelines and routines and whether these generate any results and quality improvements in relation to health outcome.
There are currently strong driving forces throughout Sweden to change and improve aspects of the organization and management of the healthcare system. These will hopefully lead to better health-related outcomes. To reduce differences and to enhance the overall quality of care, there may be a need for more continuous monitoring and encouragement from the client organizations of healthcare provision. Differences in care and treatment can be important to elucidate and analyze, as they may affect differences in health outcomes. Examples of possible strategies are to systematically and continuously collect data on different methods to improve care and its effects and to map out potential differences in access to resources. For example, regional audits could be designed to compare health-related outcomes in different care units with different types, or lack thereof, of different intervention programs targeted at patients with an incident fracture. A further example is to continuously collect information on methods and initiatives together with evidence and results from audits, which might facilitate the spread of initiatives for an improved osteoporosis care. As formulation and implementation of care pathways is still ongoing, no results are seen as yet in, e.g., the Quality and Efficiency in Swedish Healthcare indicator. There is, however, a very promising ambition to improve the outcome in the future. The selected quality and process measures presented in this report could be monitored continuously in the individual counties to maintain focus on good development. Acknowledgments Dohme (Sweden).
This study was sponsored by Merck Sharp &
Conflicts of interest EJ, DE, FB, and OS have previously consulted for companies marketing products for osteoporosis.
Appendix Definitions Study population
&
There must be systematic routines that can capture patients regardless of where they live, what type of fracture they suffered, or that their condition was forgotten for some unjustifiable reason.
Data on all patients in Sweden were retrieved from the National Patient Register and the Prescribed Drug Register, which are linked to the Cause of Death Register. Table 10
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shows details of data and study period, i.e., the time frame in which data about identified patients is collected. Inclusion criteria include the following:
Fracture codes
& &
Table 11
Age 50 and older At least one filled prescription of osteoporosis medication or a registered fracture, between 1 January 2007 and 31 December 2011 Exclusion criteria are as follows:
Index dates Two separate index dates were used in this report: (1) patients who filled their first prescription of osteoporosis medication and (2) patients with fracture. & &
Start of treatment: no registered filling of a prescription of osteoporosis medication in the pre-index period (24 months) First fracture: no registered fracture in the pre-index period (5 years)
When Bfracture-free^ or Bwithout prior fracture^ is indicated in the report, this means no registered fracture during the 5 years prior to treatment start. When Bfirst treatment^ or Bstart of treatment^ is indicated, this means no registered filling of a prescription of osteoporosis medication within 24 months.
Treatment persistence In this report, treatment persistence is defined as the total time from start of treatment to discontinuation of treatment. This is measured as the time from the first filling of a prescription until the last filled prescription runs out. Patients can have gaps between filled dosages, but is defined as non-persistent if the gap exceeds 8 weeks, including the length of the filled dosage. The analyses take into account any potential accumulation of medication from overlapping prescriptions.
Table 10
Data and study period
Included fractures are those fractures least likely to have ocFracture codes
Fracture type
ICD-10
Fracture of the rib(s), sternum, and thoracic spine Fracture of thoracic vertebra Multiple fractures of thoracic spine
S22.0 S22.1
Fracture of sternum Fracture of rib
S22.2 S22.3
Multiple fractures of ribs
S22.4
Flail chest
S22.5
Fracture of other parts of bony thorax Fracture of bony thorax, part unspecified
S22.8 S22.9
Fracture of lumbar spine and pelvis Fracture of sacrum Fracture of coccyx Fracture of ilium Fracture of acetabulum
S32.1 S32.2 S32.3 S32.4
Fracture of pubis Multiple fractures of lumbar spine and pelvis Fracture of other and unspecified parts of lumbar spine and pelvis Fracture of shoulder and upper arm Fracture of upper end of humerus
S32.5 S32.7 S32.8
Fracture of shaft of humerus Fracture of forearm Fracture of lower end of radius Fracture of lower end of both ulna and radius Fracture of femur
S42.3
Fracture of the neck of femur Pertrochanteric fracture Subtrochanteric fracture Fracture of shaft of femur Fracture of lower end of femur Fracture of lower leg, including ankle Fracture of upper end of tibia
S42.2
S52.5 S52.6 S72.0 S72.1 S72.2 S72.3 S72.4 S82.1
curred as the result of a high-energy trauma. The fracture types and the related International Classification of Diseases 10th version (ICD-10) codes are listed in Table 11. ATC codes
Register
Start date
End date
The National Patient Register The Swedish Prescribed Drug Register The Cause of Death Register
1 January 1998 1 July 2005
31 December 2011 31 December 2012
1 January 1998
31 December 2012
In Sweden, alendronic acid is recommended as the first-line treatment for osteoporosis. Zoledronic acid, risedronic acid, and denosumab are recommended as second-line treatment options. Medications with lower priority according to Swedish guidelines are raloxifene, teriparatide, strontium
Arch Osteoporos (2015) 10: 24
Page 39 of 41 24
ranelate, and ibandronate. Price, year of introduction, and subsidy limit are presented in Table 3 of the report. Table 12 below shows medications and ATC codes that were included in the report. In some counties, zoledronic acid is procured on requisition. As the Prescribed Drug Register does not collect Table 12
ATC codes
Medication
Table 13 ATC
Note
Antiresorptive therapies Bisphosphonates Etidronic acid Alendronic acid
M05BA01 M05BA04
Oral Oral
Ibandronate
M05BA06
Oral, 1 M and IV 3 M
Risedronic acid
M05BA07
Oral
Zoledronic acid
M05BA08
Etidronic acid/calcium Risedronic acid/calcium
M05BB01 M05BB02
IV infusion, 12 M Oral Oral
Alendronic acid/calcium Risedronic acid Calcium/cholecalciferol
M05BB03
Oral
M05BB04
Oral
ICD-10 codes: osteoporosis
Diagnosis
ICD-10
Osteoporosis with pathological fracture
M80
Oral SC injection, 6M
Postmenopausal osteoporosis with pathological fracture
M80.1
Postoophorectomy osteoporosis with pathological fracture Osteoporosis of disuse with pathological fracture
M80.2 M80.3
Postsurgical malabsorption osteoporosis with pathological fracture
M80.4
Drug-induced osteoporosis with pathological fracture Idiopathic osteoporosis with pathological fracture Other osteoporosis with pathological fracture Unspecified osteoporosis with pathological fracture
M80.5
Selective estrogen receptors Raloxifene Bazedoxifene Anabolic therapies
G03XC01 G03XC02
Teriparatide Parathyroid hormone (1–84) Other related medications Hormone replacement therapy Glucocorticoida
H05AA02 H05AA03
G03CX01, G03CA03, G03F, G03XC01 H02AB, H02BA
Cortisone-like medication used to treat inflammatory diseases; associated with increased risk of osteoporosis and osteoporotic fractures [34]
M80.9 Osteoporosis without pathological fracture
Osteoporosis in diseases classified elsewhere
Note
M80.0
M80.8
Other antiresorptive therapies Strontium ranelate M05BX03 Denosumab M05BX04
a
data on such products, many patients treated with zoledronic acid have been excluded in analyses.
M81 M81.0 M81.1 M81.2 M81.3 M81.4
Postmenopausal osteoporosis Postoophorectomy osteoporosis Osteoporosis of disuse Postsurgical malabsorption osteoporosis Drug-induced osteoporosis
M81.5 M81.6 M81.8 M81.9
Idiopathic osteoporosis Localized osteoporosis Other osteoporosis Osteoporosis, unspecified
M82 M82.0 M82.1 M82.8
Osteoporosis in multiple myelomatosis Osteoporosis in endocrine disorders Osteoporosis in other diseases classified elsewhere
24 Page 40 of 41
Osteoporosis codes Table 13 below provides the ICD-10 codes for osteoporosis diagnoses.
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