Background
There has been an increasing international interest in developing, improving and evaluating healthcare systems not only in terms of service, e.g. availability, but also in terms of other outcomes relevant to creating value for the different stakeholders, above all for the patients [
1‐
3]. One source of information are clinical registries, which by collecting data about medical interventions, procedures and outcomes, monitoring adherence to national guidelines, and benchmarking performance between health care providers at various levels can be instrumental in improving the quality of health care [
4]. The Swedish national quality registries (NQRs) are observational clinical registries containing information about two important knowledge systems involved in improvement, i.e. “generalizable scientific evidence” and “performance measurement” [
5]. NQRs have been stated to improve quality of care [
6,
7] and to enable fact-based decisions by patients, clinicians and managers about better care [
8]. Information in the NQRs can also be used for new and more efficient research. The development of NQRs have contributed to Sweden’s strong position in the areas of acute cardiac care, diabetes care and hip replacement surgery, and among the best survival rates after heart attack, stroke, breast and colorectal cancer [
9]. Altogether, these possibilities provide strategies for building learning healthcare systems [
4,
10]. NQRs have also been recognised as a way to follow-up on the effects on decisions at a policy level and the performance of the healthcare system [
11]. National clinical-quality registries have been developed in Australia [
12], and the Swedish NQRs may inspire other countries as well [
11].
The Swedish NQRs have also long been seen as a “largely untapped resource” [
4], especially when it comes to using the registries for research but also for quality improvement (QI) [
11,
13,
14]. In recent years, patient involvement and self-reported experience have been recognised as a gap in quality registries. The use of clinical quality registries for QI in health care has been of interest also outside Sweden (e.g., [
15‐
18]). However, the effective use of clinical registry data seems to be hampered by shortcomings in design of the digital systems [
10,
19], the lack of engagement by local staff and managers [
19], and low interest among researchers for using quality registries for research purposes [
4,
20].
To fulfil the identified potential of the NQRs more knowledge on how their use can be enhanced is needed. An opportunity for such studies arose when a five-year national investment initiative was launched in 2012 in order to promote the use of the Swedish NQRs for clinical development and QI, patient interaction, and research. The Swedish Government and the authorities responsible for healthcare jointly invested more than SEK 1.5 billion on the development of the NQRs. Accordingly, the aim of this study was to investigate what the registry management perceived as barriers and facilitators for the use of NQRs in QI, research, and interaction with patients, and the main activities undertaken to enhance their use for these purposes. The aim was further to identify potential differences between various types of NQRs for their use in these three areas.
Methods
A multiple case study design [
21] based on analyses of interviews was used to investigate the NQR’s conditions and strategies. This approach is considered relevant for research into open systems where events, processes and context cannot be controlled, as in this study [
21]. We employed an inductive approach when analysing the data, but as we were guided by previous research on quality registries as well as our own experience in managing clinical databases, we applied content analysis rather than a theory generating technique.
Setting
In Sweden, the responsibility for financing and organising health services lies upon the 21 counties and regions. Services are tax-funded and provided mainly by public providers, but the share of private services with public funding has increased, especially in primary health care. In the Swedish setting a care commissioner is “a state authority, county council and municipality in the case of such health and medical care that an authority, county council or municipality is responsible for, and other legal entity or individual entrepreneur who carries out health and medical care” [
22]. In this decentralised system, the national government uses laws and regulations, but also soft governance measures such as national guidelines and national initiatives to steer the healthcare sector [
23].
National quality registries in Sweden
In Sweden, quality registries collect information from registry users to calculate and report on quality of care indicators. In contrast to internal quality development systems, NRQs collect information from numerous care providers. The first national quality registry, initiated in 1975 by orthopedic surgeons, was the Swedish Knee Arthroplasty Register. It has since then been followed by an increasing number of registries, today more than 100, focusing on specific disorders or healthcare processes [
8]. Three certification levels were introduced in 2012 to assess the maturity and quality of a registry based on a set of indicators [
14]. The certification process is led by an executive committee appointed by the Swedish Association of Local Authorities and Regions (SALAR). Members of the committee represent different stakeholders in Swedish health care and are responsible for allocation of funding.
A quality registry is a structured and automated collection of information about patients, initiated in order to develop and secure care quality and to make comparisons on regional and national level [
24] and can also be used for research. Each registry must have a county council as legally responsible, and are subject to the laws regulating government authorities [
8]. Registries consist of a steering group, a registry holder and a registry management team (including e.g. coordinator, administrator).
Since the 1990s, registries have been able to apply for funding from national agencies such as the National Board of Health and Welfare and SALAR. In 2012, a national initiative was launched to enhance the use of NQRs for clinical development and QI, patient interaction, and research. During 5 years (2012–2016), the Swedish Government and the authorities responsible for healthcare jointly invested just over SEK 1.5 billion (in excess of the regular funding) to further develop the NQRs. Six regional Quality Registry Centres (QRCs) were also financed within this initiative to support NQRs to reach the goals of the initiative [
25].
The original purpose of the NQRs was to agree on and spread best practice. Today, the purpose has expanded to encompass research and benchmarking, which has put an emphasis on the need to guarantee the quality of the NQRs. On a national, regional or hospital level, aggregated data is compiled to compare different care providers’ results or outcomes. To support the improvement of local clinical practices, data are or need to be real-time and fed back to practitioners [
26]. Furthermore, fruitful interaction with different stakeholders requires that relevant data are collected and made available for those target groups, mainly clinicians, decision-makers on different levels, and patients.
Selection of NQRs
The selection was done iteratively in several steps in order to obtain a purposive sample. The following steps and criteria were applied. Firstly, having a certification level of 1 or 2 served as an inclusion criteria. At the time of the selection (Feb, 2015), 41 registries were certified at level 1 or 2. Secondly, NQRs were selected to show wide variation based on type of registry [
8,
20] ensuring that at least one from the following categories were included: intervention registry; diagnosis registry; and registry with a focus on prevention, palliative care, or psychiatry. Finally, the chosen NQRs were to represent the six QRCs situated in different regions in Sweden. The categorisation into different registry types is somewhat arbitrary since some registries, for example the Swedish Hernia Register, the Registry of Gynecological Surgery, and the National Prostate Cancer Registry of Sweden, could be considered both as intervention registries and diagnosis registries (Table
1). The same applies for Senior alert and the Swedish Palliative Care Registry, which could be considered palliative/preventive registries but also intervention registries with a life-long follow-up.
Table 1
Overview of the characteristics of the nine National Quality Registries studied
Acute disease/short care episode | - Swedish National Forensic Psychiatric Registry - Swedish National Registry of Gynecological Surgery - Swedish Hernia Registry | | |
Chronic disease/life-long follow-up | | - Infectious Disease Registry HIVa - Swedish Registry of Congenital Heart Disease - Swedish Follow-up Programme for Cerebral Palsy - National Prostate Cancer Registry of Swedena | - Senior alert - Swedish PalliativeaCare Registry |
Interview process
Data collection consisted of 18 individual interviews with two persons representing each NQR. Prior to the interviews one researcher (EG) approached registry holders to inform about the study, obtain informed consent to participate and book a time for a telephone interview. The registry holders were also asked to provide a second name from the registry management team who was approached in the same way. All persons approached accepted to be interviewed. Interviews were conducted in Swedish from March to June 2015 by three researchers (MAS, EG or VS). A semi-structured interview guide was developed with open-ended questions concerning how the registry had been working in order to meet the three main areas for the use of NQRs. The questions were formulated in line with the aim and focused on the following themes: action strategies, targets, activities, interaction with others, and facilitating and hindering factors. Interviews lasted from 45 min to 1 h, were recorded and transcribed verbatim.
Documents and websites were used to familiarise ourselves with the NQRs, i.e., by providing descriptions of missions, goals and activities and the scope of the NQR. The NQR organisation and financial reporting was analysed to objectify statements about staffing and financial resources.
The transcribed interviews were analysed iteratively using both conventional and directed content analysis [
27]. Two researchers (MAS and VS) separately read all transcripts to obtain an overview and understanding of the data. This was followed by a second reading where the same two researchers, separately, linked the findings to the study aim through coding and subcategorising. The analysis identified activities that the NQR management team focused on in order to reach the goals of the national initiative, i.e., to enhance the use of NQRs in QI, research, and interaction with patients. The information was compiled in a detailed matrix of their vision, activities, actors, and support from QRCs. Validation of the categorisation was done by a third researcher (EG) by going through four interviews (two from MAS and VS, respectively) independently coding them as above. The three researchers then discussed codes in order to ascertain consensus.
As for addressing change barriers and facilitators in healthcare, a directed content analysis approach was applied using Grol and Wensing’s model [
28] for the main categories
Innovation, Individual professional, Patient,
Social context, Organisational context, and
Economic and political context. A bottom-up approach was used for identifying and naming subcategories. Illustrative quotes were selected to exemplify each category. The translation of the quotes were made when finalising the manuscript and verified by all authors.
Discussion
This study, based on information from nine well-developed Swedish NQRs, has shown that they are perceived as an innovation with high potential for QI, research and knowledge development, and for patient involvement, but that the use for these purposes is still in its infancy.
One major facilitator for enhancing the use of the NQRs was having sufficient funding. The recent national investment initiative enabled the development of areas previously identified by the NQR management teams. The relatively recent focus on value-based health care was pointed out as an especially positive facilitator, as well as other contemporary national healthcare investments aiming at QI and public benchmarking. The current focus on value-based health care has also stimulated patient involvement and the increased use of PROMs and PREMs in registries. However, real patient involvement will require more direct interaction with both individual patients and groups of patients. For example, patient and patient representatives can add important perspectives of the care process, choice of variables, and data presentation if involved in the NQR steering group or in focus groups. This is something that has been encouraged by the national initiative, but a lot remains to be done. During patient consultation, clinical measures are complemented with patient dependent measures providing opportunities for a shared and more holistic overview of the patient’s health status, which can facilitate patient interaction and co-production of care [
3,
29]. It will, however, depend on whether patients are invited to participate and able to engage.
A major barrier was users having to perform double registration due to shortcomings in design of the digital systems which has also been pointed out in other studies [
11,
13]. Less capacity is then left for actually using the data for e.g. QI work, and the situation makes patient involvement and research more difficult [
10,
19]. Another barrier was the lack of authority on behalf of the registry management teams to request participation in the registry as well as in QI activities based on registry outcomes. The registry management teams were aware of the fact that they do not have the mandate to “force” the units to use the NQRs. Their option to impact healthcare professionals is rather to use “peer pressure, shaming and a sense of moral responsibility” described as potential compliance mechanisms [
30]. Studies have revealed a shortage of supportive structure in terms of committed and accountable leadership at the political and clinical levels [
13,
30] as well as a lack of engagement on behalf of the local staff and managers in using quality registries for QI work [
4,
19,
20]. The lack of formal mandate was also pointed out by QRCs as a main challenge when supporting NQRs to be used in healthcare organisations [
25].
In fact, one could say that this whole initiative lacks a multilevel approach in accordance with Ferlie & Shortell’s Framework for change, which is characterised by four essential core properties needed in order to really achieve change and thereby improved quality of care. These core properties are: “1) leadership at all levels; 2) a pervasive culture that supports learning throughout the care process; 3) an emphasis on the development of effective teams; and 4) greater use of information technologies for both continuous improvement work and external accountability” [
31]. The national initiative has so far mostly been focused on number four, through increasing the use of NQRs whereas less emphasis has been on numbers one to three, which concern leadership, change of culture and behaviours. Furthermore, it is important to understand that barriers to change exist at different levels; both individual, team, organisation, and system levels. Strategies for change need to be tailored for each and every one of these levels [
31,
32].
Indeed, the great variety of strategies among quality registries to achieve the three goals of the national initiative, i.e., to increase their use for QI, research, and patient engagement, may reflect that more emphasis was put, on the national level, on policy formulation than policy implementation. We find the model for evidence-informed policy formulation and implementation, presented by Strehlenert et al. [
33] enlightening in this respect. The national initiative did have an element of “capacity building”, as six regional QRCs were established to support NQRs. In terms of implementation, the annual cycle of funding application and reporting acted as “raising awareness” among NQRs about the targets. But there was less emphasis on supporting the “adoption” of strategies among NQRs, as well as “implementation” and “maintenance” in terms of integrating the NQR strategies into their ordinary operations. More focus on those elements of policy implementation could have improved the efforts of NQRs to reach the goals, and, subsequently, increased the success of the national initiative.
The registry management teams used three different strategies to enhance the use of NQRs within the three focus areas: ensuring registering of correct and complete data, ensuring updated and understandable information available for all stakeholders, and intensifying cooperation with relevant stakeholders. However, the need of improving methodological competence among registry researchers, especially concerning use of epidemiologic methods, did not surface as a chosen strategy to enhance the use of NQRs. This has been emphasized by Adami and Hernan [
4] as a crucial strategy for increasing the value of NQRs within research. Additionally, the possibilities of using NQRs for randomised trials – even mega trials as has been pointed out by Lauer et al. [
34] – was not mentioned as a possible strategy. There is a risk that the NQRs will remain an “untapped resource” when it comes to using NQRs for research purposes as long as such strategic approaches are overlooked [
4].
Furthermore, there were no examples in our study, that the registry management teams offered support for benchmarking processes. Such processes differ from standard quality improvement processes by “the dynamic of comparing and learning from each other” [
35] and the “comparative evaluation and identification of the underlying causes leading to high levels of performance” [
35,
36]. The strategies mentioned to support the improvement of the results of less successful organisations were described in terms of classical internal quality improvement projects without the elements of benchmarking, i.e., learning from those with the best results in order to understand what makes their organisations so successful. Such initiatives would not only clarify the need for change of practice but also contribute to the insight into the contextual barriers (organisational, social, and professional) in their own organisation that counteract desirable changes [
32].
The characteristics of the NQRs have an influence on their use. This study showed that the type of registry and its potential use may be connected to what kind of data is registered, the specific condition or type of care process followed, whether it is acute/short or chronic/life-long intervention, and if the registry focuses on diagnosis or on risk assessments and prevention. This has also been observed by Fredriksson et al. [
14] studying the usefulness of using data from the NQRs for QI. These observations should guide further studies on strategies to promote the use of NQRs.
Methodological considerations
Most of the previous studies involving NQRs have focused on one registry or addressed the NQRs as a phenomenon (e.g. [
8,
11,
13]). This study is based on nine NQRs out of approximately 100. We used sampling methods aiming at maximising variation and registry purpose. However, generalisation to all registries should be made with caution. The registries are managed by a limited number of people and out of them we chose the registry holder who in turn chose one of his or her colleagues that had knowledge on the use of the registry in the three focus areas. Interviews with e.g. non-registry staff could possibly have provided more variation in views. To ensure reliability in analyses three researchers were involved and we checked for validity, in both a-priori categories and inductive analyses. Websites and documents complemented the interview, but they risk being biased by efforts to present NQRs in a favourable way.
Conclusions
This study has shown that the potential use of NQRs for QI, research and interaction with stakeholders is related to the funding of the registries and that a recent national investment initiative contributed to already ongoing purposeful work to strengthen what was seen as facilitating factors (such as technical development) and likewise counteract perceived barriers (such as lack of authority). Whether this in fact led to the intended goal of the initiative: increased use of NQRs for QI, research and interaction with stakeholders, has not been examined in this study.
The way the registries in fact are used for these purposes is a question for the end-users, i.e. the clinicians, the researchers and the patients. For future national investment initiatives, where an increased use of the registries is desirable, the needs of these end-users must be in focus. Since there is a great variation between different types of registries it is reasonable to believe that there is variation in prerequisites when it comes to enhancing their use for QI, research and interaction with stakeholders. However, the end-users of the different registries may all have in common a need for information on and training in the methodology of registry based research as well as benchmarking methodology, i.e. how to learn from best practices, and how to involve patients and families in patient centred care.