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Continuous innovation: developing and using a clinical database with new technology for patient-centred care—the case of the Swedish quality register for arthritis

John Ovretveit, Christina Keller, Helena Hvitfeldt Forsberg, Anna Essén, Staffan Lindblad, Mats Brommels
DOI: http://dx.doi.org/10.1093/intqhc/mzt002 118-124 First published online: 29 January 2013

Abstract

Objective We describe and explain the development of a clinical quality database and its use for different clinical, management and patient empowerment purposes.

Design A longitudinal case study covering 1993–2009.

Setting Rheumatology departments in Swedish hospitals.

Participants Those involved in developing the clinical database and its applications and a limited number of users.

Intervention(s) Different methods for inputting and storing clinical and patient data and for analysing and presenting the data to providers and patients.

Main outcome measure(s) Participants' perceptions of the value of different applications and of influences, which helped and hindered the development of the system.

Results Different innovations were introduced at different times continually to increase the ultility of the clinical data and the clinic- and patient coverage of the clinical data system. Limited interview data show postive patient and provider perceptions of the latest application to collect and present data as time trend visual display in the clinical consultation.

Conclusions A longitudinal perspective revealed how a clinical quality register was developed and how new technologies not imagined in the early 1990s continue to increase the ultility and value of the clinical database. This historical perspective provided limited evidence of impact, but does provide lessons for current strategies for innovation for quality in health care and of the need to consider innovolution processes, rather than discrete innovations, given the rapid pace of change in new technologies. More evidence is needed of the impact of such registers, and of enhancements, on providers and patients and on costs.

  • clinical database
  • quality
  • safety
  • improvement

Background

Innovations in clinical databases and in new ways to support patients with chronic health conditions have great potential to reduce avoidable suffering and costs. But, there are challenges in developing and using these innovations. This paper presents findings from longitudinal case study that documented the development and combination of different information and communications technology innovations for the care of patients suffering with arthritis, using the national Swedish clinical quality database—the ‘arthritis quality registry’. This included enabling patients to input data into the system and to understand trends in their disease symptoms and treatment, which may enable them better to self-manage their condition. The lessons from this innovation have implications for improving care of patients with other chronic diseases and for reducing health-care costs.

A central principle of quality improvement is to test changes using reliable data, or ‘fact-based improvement’ [1]. A clinical database is a system for storing and providing access to clinical information about more than one patient. Most are now in electronic form on one or more computers. They have been developed for a number of purposes, but one is for quality improvement. Recording a patient's demographic, treatment and outcome data makes it possible to assess the results of changes to treatments or to the organization of care [2].

Clinical registers

‘Clinical registry’ is the term often used to describe a clinical database for collecting and providing patient data about one or more health conditions: for example, a primary health-care centre makes a list of all patients with diabetes, or of patients over 75 years old. The scope may be limited to one or more types of patients served by one or more physicians in a group practice, or may cover patients served by a health system or may cover all relevant patients in a nation [3, 4].

An authoritative guide to such registries describes some of their uses: as a tool for observing the course of disease; for understanding variations in treatment and outcomes; for examining factors that influence prognosis and quality of life; for describing care patterns, including appropriateness and disparities; for assessing effectiveness; for monitoring safety and harm; and for measuring quality of care [4].

One of the uses for clinicians is to allow rapid collection of data about disease presentation and outcomes in many patients, giving a ‘real-world’ picture of disease, current treatment practices and outcomes. Hospitals and physician organizations can use a registry to assess compliance with guidelines, to consider aspects of a disease that might otherwise be overlooked, or to enable clinicians to make peer comparisons [5]. Their values to purchasers and funders of health care are to give information about how procedures, devices or pharmaceuticals are used and on their effectiveness in different patient groups. They are also useful for drug or device manufacturers in different ways, such as for clinical trials or to monitor outcomes, including adverse events in real world clinics. It is thought that there is a rapid increase in the number and use of registers, possibly accelerated by new information technology. However, there is little empirical research on the variety of types and uses of registers or of their effectiveness for different purposes.

The data for registries can be entered in different ways. Some electronic medical record (EMR) systems allow registry managers to aggregate data from individual patient EMRs so as to populate the data fields for patients covered by the registry. In theory, patients could input data directly into provider-operated registers (the authors are not aware of any operational example of this). A patient can use an analysis of his/her own data on the registry to manage his/her health and to enable shared decision making with physicians about treatments [6, 7].

To date, the term ‘clinical register’ has not been used to describe web sites for patients, often run by independent companies, where patients input their self-monitored clinical data. Such companies build a database of patient ‘clinical data’ from this and provide patients with ways to compare their symptoms, treatments and outcomes with ‘patients like me’ [8]. Related to this is the emergence of personal health records (PHRs), which are, ‘An electronic application through which individuals can access, manage and share their health information, and that of others for whom they are authorized, in a private secure, and confidential environment’ [9, 10].

The linking of PHRs and EMRs and linking both to a clinical database or registry are in the early stages, not least because of issues of privacy and data security. About 300 000 US veterans each have their own PHR through ‘my healthevet’ [10], but it is unclear from reports about the extent of linking of this with other veterans' health administration databases [6]. There are no reported examples of patients' individual PHRs being used as sources of data for clinical registries.

Although there are a number of uses for registries and they are increasingly showing their value for managing chronic conditions, there are challenges in developing and using clinical databases: challenges in ensuring that valid data are entered at a low cost and without extra physician time, in ensuring privacy, security and authorized easy access, in providing reports and analyses to different parties in a timely and cost-effective way to influence decisions and in financing development and operation of registers [10].

This paper considers how these and other issues were addressed by drawing on a longitudinal case study of the Swedish arthritis rheumatology register [11]. It describes the methods for the case study, some of the findings and considers how a clinical database was transformed from a research tool to serve purposes as a patient treatment management tool for providers, a patient activation and empowerment tool and a departmental-clinic management tool.

Methods

A longitudinal case evaluation was carried out between 2008 and 2009 covering the period 1994–2009. The case study collected data about aspects of development of the quality register and about how this was used as a basis for other innovations. The study aim was to describe the continuing innovation of the register and its applications and to understand influences that helped and hindered the innovations, so that others could develop and implement similar innovations more effectively.

Part of the method was to use a four-category framework [12] to guide collection of data about,

  1. the content of the innovation and how this changed,

  2. the process through which the innovation was developed, applied, spread and further developed,

  3. the context that influenced its development and how this changed, including the availably of new pharmaceuticals, new types of information technology and financing and

  4. intermediate and patient outcomes that could be attributed to the innovation in part or whole.

Data were collected from semi-structured interviews, local service statistics and documents. The latter included agreements, articles, meeting minutes and presentation materials (Supplementary Appendix). Interviews based on critical incident technique [13] were conducted with the clinician leading the implementation, and the registry manager, the national quality coordinator, researchers and others playing a significant role in the development and implementation of the register (Supplementary Appendix). Limited data about patients perceptions of the innovation were also collected through interviews and a survey between 2004 and 2006 with 44 patients at two clinics, where the patient-centred pilot part of the innovation was introduced [14].

A report of the methods and case is provided in [11], and longer detailed reports are also available from the corresponding author of this paper.

Results

The development of the database and the innovation and spread of the use of the register

The development and spread of the innovation occurred in the following phases:

  1. 1995—start of the quality register in 7 Swedish hospital departments of rheumatology (out of 60 departments at that time),

  2. 2000—use of a stand-alone computer in 1 department, to collect and present data to clinician and patient,

  3. 2006—increasing use by departments of online data entry into the national database and use of benchmarking reports,

  4. 2008—development of patient empowerment web tools and systems for patients and

  5. 2009—all Swedish departments enter data, and a few enable patients to enter their self-assessment data directly from home, and to carry out self-monitoring.

The start of the rheumatology register in 1995

Three ‘context factors’ were described by interviewees as influencing the start of the rheumatology quality register in 1995. One was the development of other quality registers since 1979, which provided examples of the value of collecting clinical data and different protocols for deciding which data to collect and how to collect and report the data. A second was the discovery that early detection of arthritis and intervention could significantly reduce later deterioration and debate in the specialty about how best to speed diagnosis. A third was new more effective combination drug therapies, which increased the need for more careful monitoring and adjustment of medications. Arthritis became viewed as a more treatable disease, and so did the value of assessing outcomes.

The idea of quality register for rheumatoid arthritis was presented at the 1993 annual conference for Swedish physicians. This led to a spontaneous meeting at the conference of about 50 rheumatologists, initiated by the now current registry manager. A task group was formed to develop a prototype for a national monitoring system.

The paper-based register

The first register was based on patients filling out a paper form giving demographic and previous treatment data before the physician consultation. After the consultation, both the patient- and the data about treatment were entered into the quality register by a physician, a nurse or an administrator. At the start, the costs of the unit hosting and running the register were paid by the Ministry of Health and the Federation of Swedish County Councils, and the costs of data entry were borne by the participating departments.

Some interviewees reported that the registry manager and other leaders of the registry group had to engage in considerable ‘selling’ and ‘persuasion’ to increase participation in the register. Contracts also were reported to be important between the registry and hospital departments for establishing clear agreements about which data the departments would provide and how and what the registry would provide. Before the start of the register in 1995, there was debate about which data were most needed and about the need for the register: There was much discussion about why we had to do this, and – above all – why everyone should spend so much time on filling-out forms.’ (registry manager)

Some physicians wanted to measure many indicators of the disease and ‘entered too much data’ in the register. Some were reported by the registry manager to be afraid of others assessing the quality of their care. Other interviewees reported also that some physicians thought that the paper-based forms were too expensive and time consuming and found reasons for not including some patients. The more processes and information systems that are imposed on us by someone else, who thinks that this is really great, the more time is lost in close contact with patients, to examine their joints, to treat them properly.’ (Clinical manager) There is no data from the quality register, which I couldn't find in the electronic medical record. Preferably, the two information systems should be interacting.’ (Clinical manager)

Interviewees explained the limited initial participation on the basis that the arthritis register was one of the first ‘disease-oriented’ quality registers and was different from other earlier ‘method-oriented’ registers that recorded surgical procedures. The purposes and functions of the method-oriented quality registers were widely known and accepted, whereas disease-oriented registers were considered untried and different. The arthritis register collected more data about the diagnosis of the patient and recorded all relevant treatment.

Innovation in pharmaceuticals and in side effect recording

Until 1999, the emphasis of the register was on data about treatment of early arthritis. From 1999, more effective and expensive ‘biological’ drugs became available, and also a Swedish law came into force requiring the documentation of the side effects of new pharmaceuticals. The leaders of the registry were able to agree with pharmaceutical companies on an addition to the register to allow recording and reporting of side effects to meet the law, in return for some funding for the registry from these companies. The registry became important as a means for providing details about and justification for the high cost of the new medications, By means of the register we can tell politicians that a certain number of patients need biologic drugs. Without the register we wouldn't have stood a chance.’ (Rheumatologist)

Computer and information and communications technology innovations in 2000—enabling shared decision making

A number of interviewees reported that an ‘important innovation’ occurred in 2000 in the collection and use of data by one department. Rather than filling in paper forms, patients visiting the Karolinska University Hospital department of rheumatology entered their data directly into the department computer that also held the registry data for the department. Patients entered assessments of their general pain, global health, daily function, swelling and tenderness of 28 index joints.

At the same time, a second innovation was reported in the presentation and use of the data in a patient–physician consultation a few minutes after the patient entered the data. Before this consultation, a patient health status index was calculated by the computer: the ‘DAS28’ (Disease Activity Score of 28 joints [15]) from the patient's entries. The computer then presented the score for this visit and for previous visits to the physician and the patient in the consultation on a visual graph. This made it possible for physician and patient together to see changes in disease activity and formulate hypotheses together about the causes of these changes. Hypothesis testing about possible triggers of disease activity was also informed by the data. The system presents graphically on a computer screen, viewed by patient and doctor, the dates of treatments over time, such as drug doses, in parallel with the disease activity scores entered by the patient.

By 2008, 2042 patients were using this pre-consultation data entry method, of the approximately 29 000 patients registered. In this department, the data for the registry were in the department computer. A third innovation in 2001 made it possible for other departments to enter data into the registry online through a web-based interface. This direct data entry, rather than mailing the data, allowed faster updating of the registry and more timely reports to departments.

Patient empowerment innovations

A fifth series of innovations were in empowering patients in the physician consultation and in their self-care. The following innovations have been pioneered at the Karolinska hospital department, although not all of these are used routinely by other clinics at this time:

  1. Shared decision making: the visual display of the disease activity score described above and the treatments over time help the patient to understand why their pain may have varied and help them take a greater role in deciding treatment and lifestyle changes. The sense of control is encouraged and helped by their preparation for the consultation by entering their self-assessments in the pre-consultation session.

  2. Follow-up choice: patients with a controlled inactive disease are given a choice about whether or when to make an appointment, for example when an increase in disease activity and pain occurs. The reduction in regular appointments allowed space in the clinic schedule for patients to make a quick doctor appointment (2 days) when they need it. Two-thirds of these patients now have no scheduled appointments and also have the possibility of the further choice making a specialist nurse appointment for a checkup and discussion of any issues.

  3. Personal experiments: the self-assessment system allows more accurate tracking of disease activity and this helps patient and physician to formulate ‘hypotheses’ to explain increases in activity or pain. The patient is then empowered to test these ‘hypotheses’ through training on how to do ‘personal experiments’.

  4. Online cognitive behavioural therapy programmes are provided to support lifestyle changes.

  5. Online and other activities are given to share experience with fellow patients and provide mutual support.

  6. Online and other methods to involve patients in suggesting improvements to clinical services and in designing the changes.

  7. Self-assessment data entry at home. This seventh patient empowerment innovation was in Dalarna county. Here, patients assess and enter their disease activity at home with their own online user interface with the database.

The spread of the quality register

There was a rapid increase from 7 clinics using the register in 1995 to 40 by 1999. The increase slowed during 2000–2005 from 40 to 44, but the number of patients covered increased from 4625 to 16 131, indicating that the participating clinics were including more patients over time (Figs 1 and 2).

Figure 1

Percentage of clinics included in the Swedish rheumatology quality register 1995–2009.

Figure 2

Percent of patients included in the Swedish rheumatology quality register 1995–2009.

Estimates of the percentage coverage of the register out of the total Swedish population with rheumatoid arthritis are less certain because of varying approaches to defining and estimating ‘the total Swedish population with rhematoid arthritis’ and defining which patients could benefit from being on the register. For example, the coverage could increase, if the register were to include patients whose disease is managed by approaches other than medications (such as new internet and mobile applications). Nevertheless, a rough estimate of coverage is shown in Fig. 2 that displays the prevalence of patients diagnosed and receiving biological drug treatment over time [16, 17].

Although 100% of clinics were participating in 2012, their involvement in and use of the register for improvement varied. Some only enter data into the register. Those that use the data in the register reported three main uses. The first was comparing medications or outcomes with similar departments and populations. The second was use by patients and physicians of the information that the system can present to them about symptoms and medications over time in the shared decision-making consultation, described above. The third use, by a few departments, is for the patient to enter data from home over the Internet. The department then uses these data to offer the option of follow-up via specialist nurse support, rather than regular appointments.

Patient and provider results

Only limited data are available about patients' and providers' perceptions about the patient-centred point of care register service. Interviews with 44 patients found patient satisfaction with this service to be high and included the following frequent comments, about the data entry system using a visual display to enter pain scores and presentation of the treatments and pain scores over time: ‘Quick’; ‘Easy and efficient’; ‘Gives the patient more time with the provider’.

Other comments made by individual patients included, ‘Clear’, ‘Easy overview’, ‘Easy to follow-up—you can easily see progress’; ‘You can see the effect of your treatment’; ‘I have the same data and information as my physician’; ‘When used at home I could spend more time with the questions and looking at the overview’; ‘It helps me remember what to talk to my physician about’; and ‘Questions come up that I don't think would have done so without the system’ [14].

The case study gathered provider perceptions of the 2008 system documenting consistently high satisfaction and perceived advantages. Comments made by physicians included: You get an overview of the disease [by means of the register], and that is difficult to achieve by only unstructured, longitudinal notes. You get structured and quantified data, which makes it easier to evaluate the actual health status of the patient (rheumatology department researcher). To read the health status overview before the medical consultation saves ten minutes, which I can use to examine the patient, instead of trying to scroll through, e.g. 750 pages of written medical records.’ (Clinical manager) It is like having a third person in the room … But it feels secure and comfortable, as the computer presents facts and not guesses or beliefs … The patient tells me that he or she doesn't feel very well. Then I look at the results from the laboratory tests or the [DAS28] index, and I can confirm that the patient's health status has deteriorated. It is a fact and not just a vague perception or whimpering.’ (Rheumatologist) With the register, some patients really dare to tell me that they only take four pills each day instead of eight, which I prescribed. I think that this brings a clarity and an honesty [to the medical consultation], and finally perhaps compliance will increase because the patients feel involved … Treatment will be more equal as all patients have the opportunity to measure disease activity – and then you will discover the patients that really have a high disease activity. And that might not be those patients who complain a lot or make many telephone calls.’ (Clinical manager)

Some providers felt that the utility of the system could be improved: A connection to the electronic medical record would reduce time to register data. (Head of rheumatology unit) More diagnoses and variables could help us include more patients. (Clinical manager)

Discussion

There a few reports of the development and spread of large-scale registers [18] or which highlight how new technologies can transform their value. The clinical value and cost-effectiveness of such registries remain unproven. This case study describes the development and use of a Swedish arthritis quality register and how its value and use were significant improved with information technology and presents a preliminary assessment of its impact on patient care, satisfaction and outcomes. It provides some evidence that may be of use to others developing clinical databases that include patient-reported outcomes and those who are considering how to use information technology to improve patient care. It shows how different technologies can be used to make the maximum use of clinical data about populations of patients for different purposes, once these data are collected and stored digitally.

The case study is subject to important limitations. Although it draws on documentary data, the other data used from interviews were from a small sample of mostly advocates for the register and relied on their memory of events. Hindsight over-coherence and bias are likely. Similarly, a small sample of interviews was used to assess perceptions of impact and about possible outcomes of the registry. This paper, thus, provides little evidence of impact on providers or patients, and any conclusions need to be viewed in the light of the little evidence on these subjects from this or from other research.

Despite these caveats, a number of observations emerge that may be of use to others in developing clinical databases. There a few reports of the development and spread of large-scale registers [18] or which highlight how new technologies can transform their value. Although limited, the case study is of interest to others developing clinical databases and considering how to use information technology to improve patient care. It shows how different technologies can be used to make the maximum use of clinical data about populations of patients for different purposes, once this data are collected and stored digitally.

The later innovations that accelerated the use of the register concerned direct data entry and reporting. Participation in the register was said to be lower in the early stages because data were entered by patients and providers onto paper forms and then submitted for data entry onto the register. This added time and costs to the visit that were not viewed to be justified by the reports posted back some time later by the register organizers.

Moving from paper- to direct-data entry for patients and for providers over the internet reduced time and costs. It made data entry instant and allowed instant comparative reporting back to the provider and patient. This was made possible not just by the Internet interface, but also by new powerful software that allowed the provider to present time-trend comparisons of disease activity and treatment, shortly after the patient inputted their recent scores. New display software allowed this to be presented visually on a screen in ways in which patients could understand and discuss with the provider.

It was the addition of these innovations that transformed the value of the register for a range of purposes that also included higher level comparative reports for management purposes. These were a second-generation set of innovations built on the register data and infrastructure. The third generation of innovations, which are under development, are to use mobile communications technologies to enter in data and to enable patient self-management.

The longitudinal and context-sensitive case study method used in the research revealed number of features of clinical database innovation:

  1. A network effect: the more physicians and departments entering data, the more valuable the data became because this increased the validity of the comparisons and assessments that were possible.

  2. The database allowed for multiple uses: originally a database for research, it was later used to record medication side effects to meet regulatory requirements, to track the effects of quality improvements in clinics, to provide individual physicians and units with comparative feedback for management purposes and to enable patients to take a greater part in their treatment and self-care.

  3. Clinician ownership, leadership and functionality: the physician leadership and ownership of the register were essential to start and develop the register, but even then, take-up was slow and data entry was considered to be too time consuming by many.

  4. Spreading or scaling up an innovation: in addition to physician champions, scale up also required an infrastructure of organization and systems to enable the spread of participation and also planning and execution with accountability for development and use of the register.

  5. The pace of change: in 1995 no one foresaw the Internet, software and mobile communications technology of 2012, or the increasing significance of chronic illness. Yet, the investment was made, and the infrastructure built, which then enabled the current uses of the register and future uses such as genetic research and others that we cannot imagine.

  6. Financial issues: starting, developing and operating a clinical database requires finance for staff time and systems. Yet, the case shows that this basic infrastructure then makes it possible to add later innovations that allowed the use of the data for different purposes for different parties. The Swedish government–physician cooperation, while aware of costs and savings to different parties, was able to subsidize start-up and development without knowing the later value and use to which the system was to be put. Participating departments funded the time and systems changes they needed to make, and the national system and its spread was funded by national government, with partial funding from pharmaceutical companies. The commercial exploitation of the patient-centred care system is one possible future development.

Conclusion

Quality registries can be used for a number of purposes. This and other studies provide limited evidence of their impact on providers or patients, or about costs. This lack of strong evidence needs to be borne in mind when deciding about adoption and development.

Evidence from this case study suggests that their development and spread requires energetic clinical champions and attention to and expertise in planning, organization, financing and information technology systems. New information technology and the Internet are opening up the possibility for greater patient involvement in providing clinical data and in their using data provided by, or supplemented by a register. It is transforming the value of clinical databases in ways that were not imagined even 5 years ago.

By viewing the development of the register over time, different sub-innovations in an ‘inno-volutionary’ process were highlighted. The case showed the influences that helped to move the ideas into routine practice and also those that present challenges to similar and further innovation, especially investment and operational financing challenges, if too narrow, too short and too calculative a ‘pay-back’ perspective is taken. A new generation of mobile IT-supported registers is emerging that can allow patients to make real-time adjustments to their treatments and lifestyle.

Acknowledgements

The research on which this paper is based draws on a case study funded by VINNOVA (Swedish Governmental Agency for Innovation Systems) and The Vårdal Foundation, Sweden.

References

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