Background
Evidence-based clinical practice guidelines universally recommend patient education, advice to remain active and at work, and exercises as frontline interventions to help people with persistent and/or recurrent episodes of back pain to self-manage [
1]. In spite of this, non-evidence-based practices including excessive testing and imaging, prescription of opioids, spinal injections and surgery are commonly used for these patients, and a significant evidence-practice gap exists [
2]. Leading back pain researchers are calling for implementation of guideline recommendations in order to avoid harmful treatments in all settings globally [
3].
An example of a successful implementation of clinical guideline recommendations is the GLA:D (Good Life with osteoArthritis in Denmark) for the knee and hip [
4]. This program consists of a two-day course that trains clinicians in delivering GLA:D, a standardised evidence-based program for knee and hip pain. GLA:D includes two sessions of patient education and 12 sessions of supervised exercise therapy aimed at teaching patients to self-manage their pain and functional limitations, as well as registration of their data in a clinical database, where they are monitored for one year on a number of outcomes such as pain, physical function, pain medication and quality of life [
5]. Since 2013, more than 1000 physiotherapists have been certified and around 36,000 patients included in the clinical registry in Denmark [
4,
6]. After participating in GLA:D knee and hip, pain decreased by 26–27%, function improved, fewer people took pain-killers and fewer people were on sick leave [
6]. In addition, GLA:D is currently being implemented in Canada, Australia, and China [
6]. The GLA:D approach appears to be an effective, feasible and fast method to implement recommendations from clinical guidelines in clinical practice, and a similar approach might be useful to implement recommendations from clinical guidelines for back pain.
Due to the successful implementation of the GLAD knee and hip program, we had requests from clinicians for a similar program for people with back pain. From our networks and collaboration with clinicians, we also had very positive responses to our initial ideas and we therefore found it timely to develop GLA:D Back.
The overall aim of this project was to develop and implement GLA:D Back, an intervention that compiles elements of effective and generally recommended interventions into a standardised care package that is feasible to be delivered by clinicians in primary care (Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Protocol for a hybrid effectiveness-implementation study, submitted). The intention was to promote self-management for people with persistent or recurrent back pain. A self-management intervention has previously been defined as ‘a structured, taught, or self-taught course with distinct components principally aimed at patients (rather than carers) with the goal of improving the participants’ health status or quality of life by teaching them skills to apply to everyday situations’ [
7]. The following components have been suggested: psychological (including behavioural or cognitive therapy), mind-body therapies (including relaxation, meditation, or guided imagery), physical activity (including any form of exercise), lifestyle (such as dietary advice and sleep management), and pain education (such as understanding the condition and how to take medication effectively).
In this paper, we present the development, theories, and underlying scientific evidence for the GLA:D Back program, which consists of a standardised clinician-delivered care program for back pain comprising group education and supervised exercises aimed at supporting self-management in people seeking care due to persistent and/or recurrent back pain.
Methods
In Section 1, we describe the rationale for developing GLA:D Back, in Section 2, we describe the objectives of the intervention and the hypothesised model of change, Section 3 describes the program design and the underlying theories and evidence, and Section 4, the final content of the program. The implementation and the evaluation of the intervention are described in a separate protocol paper that describes the educational intervention targeted at the clinicians, who will deliver GLA:D Back (Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Protocol for a hybrid effectiveness-implementation study, submitted).
The reporting of the intervention development is inspired by the framework of Intervention Mapping, which is a method for developing behavioural change interventions [
8‐
10]. It is particularly useful in complex intervention development as a theoretical framework for optimising potential effects of a new intervention [
11]. Accordingly, Section 1 is primarily based on literature reviews and extraction of themes relevant for a group-delivered intervention focusing on self-management. Group and consensus discussions led to the outlining of the objectives for the intervention in Section 2. Section 3 is based on literature reviews of the theory and evidence to support the hypothesis derived from the objectives. The components of GLAD Back are described in Section 4 and based on outlined supporting evidence from the literature in Section 3, as well as piloting and feedback from people with back pain participating in the preliminary program and clinicians participating in the initial training and delivery of the care package (Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Protocol for a hybrid effectiveness-implementation study, submitted and Kongsted A, Hartvigsen J, Boyle E, Ris I, Kjaer P, Thomassen L, Vach W: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Feasibility of implementation by a clinician course, submitted). More details can be found under the heading Intervention Development.
Organisation
The planning of the GLA:D Back intervention was led by the primary working group (PK, AK, IR and JH) at the University of Southern Denmark (SDU) with the involvement of invited expert clinicians and a multidisciplinary research group of national and international experts within the field, as well as an advisory board (see Acknowledgements).
Some members of the primary working group (PK, JH) are also involved in the Horizon 2020 project
selfBACK [
12] that aims to develop a digital decision support system for people with back pain to facilitate, improve and reinforce self-management. One of authors involved in the expert group (AA) is leading the Swedish study implementing a similar program called the BetterBack☺ model of care [
13]. The interventions of the GLA:D Back,
selfBACK and BetterBack☺ are developed in parallel and share the same theoretical base and several specific components (Svendsen MJ, Sandal LF, Kjaer P, Nicholl BI, Cooper K, Holtermann A, Mair FS, Hartvigsen J, Stochkendahl MJ, Sogaard K et al: Intervention mapping for developing an app-based decision support system to improve self-management of non-specific low back pain (SELFBACK), in preparation).
Processes
The literature reviews and drafts for Sections 1–4 (
rationale for GLA:D Back, the program objectives, the program design, theories and evidence, and the program) were prepared by the primary working group at SDU in close collaboration with the other authors and people from the multidisciplinary expert group. This was a non-linear process involving literature reviews, group discussions, consensus processes, initial testing and pilot studies [
8,
9].
Intervention development
Section 1,
rationale for GLA:D Back, was based on literature dealing with back pain, its consequences for the individual and the society, prognostic factors for disabling back pain as well as the challenges facing clinicians. Section 2,
program objectives of GLA:D Back, was developed by the primary working group at SDU using an iterative process, with feedback from the expert group, and in collaboration with the
selfBACK [
14] and BetterBack☺ groups [
13]. It included the results from the processes related to Section 3,
program design, theories and evidence, with core elements for the intervention content extracted from clinical guidelines, reviews and randomised controlled trials and these were discussed in the multidisciplinary expert group. Inclusion criteria for the selection of components for the intervention were that they should 1) include patient education, 2) be suitable for groups of patients, 3) be targeting patients with recurrent and/or persistent non-specific back pain, and 4) address factors related to poor outcomes. Consensus on the inclusion of these components was sought over two rounds, where members of the multidisciplinary expert team gave their feedback on, and prioritised, educational aspects and exercises. The first GLA:D Back intervention was then outlined by the authors and further discussed with the multidisciplinary expert team. In Section 4, the final components of the GLA:D Back program were described as well as the testing of this program. The first version of the program was tested initially at the university clinic at SDU by PK, IR and AK and the second version in a pilot study in nine primary care chiropractic and physiotherapy clinics. The detailed results from these studies are reported in separate publications (Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Protocol for a hybrid effectiveness-implementation study, submitted and Kongsted A, Hartvigsen J, Boyle E, Ris I, Kjaer P, Thomassen L, Vach W: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Feasibility of implementation by a clinician course, submitted).
Discussion
This paper describes how we developed the GLA:D Back program for people with persistent or recurrent back pain including its underlying theories and scientific evidence. The overarching aim of the program is to improve the ability of people with persistent or recurrent back pain to self-manage. The elements of GLA:D Back target factors that broadly affect prognosis for pain, activity limitation and deconditioning, and these elements are well suited to self-management. Thus, the novelty as compared with existing self-management interventions for back pain is the integration of patient education and exercise therapy that includes a clear aim to address known prognostic factors for developing back pain related disability. In addition to this, it was a strong focus to make the intervention feasible and acceptable for delivery in primary care after a short training course, and furthermore, that registration of patient outcomes in a clinical registry is a mandatory part of the program. Importantly, contrary to most existing programs, links to theories and existing evidence are made explicit during the course, in education material and in publications such as this one.
Reasons for creating the GLA:D Back included requests from clinicians due to the success of the GLA:D knee and hip program [
5], and our intention to develop an evidence-based care package based on the most recent clinical guidelines available to patients and clinicians. We reviewed and analysed the scientific literature about back pain, its clinical course, related disability, prognostic factors, and qualitative studies about the challenges faced by clinicians when managing people with back pain. We involved clinicians in the reference group but did not systematically study clinicians’ need prior to developing the program. Also, within the multidisciplinary research expert group, many different professions were represented both as clinicians and researchers.
The burden of back pain disability is evident worldwide, not just in Denmark [
15‐
18]. Reducing this burden will not be achieved by GLA:D Back alone. There is an urgent need for system changes and an even larger-scale implementation of evidence across professions and sectors. We could have involved in the design of GLA:D Back more diverse health system stakeholders from the Danish regional health authorities, politicians and professional health care organisations, who are responsible for organising and delivering health care in Denmark. However, our experience has been that this can often be challenging when discussions regress to being about managerial, budget and professional political interests. During the process, we were approached by one regional health authority and we arranged meetings that included representatives from GPs, chiropracto rs and physiotherapists from the five regions of Denmark. This has resulted in a continuing and positive dialogue with the regions and the health care provider representatives. We believe that this on-going dialogue has eventuated because we intended to develop and offer courses in GLA:D Back regardless of objections from administrators or professional organisations with vested political interests.
GLA:D Back is unique as a group intervention because of its close integration of patient education and exercise using an individualised cognitive approach, which is driven by the patient’s personal goals and capacities. In the literature, combined and individualised multifaceted interventions seem to have superior outcomes when compared with interventions that have single-facetted interventions [
37,
95,
117‐
123,
125,
126]. Therefore, we designed the program to implement the key messages from the educational sessions into the exercise sessions. This was possible because GLA:D Back is founded on social cognitive theory, cognitive behavioural theory [
68], operant conditioning [
53], and behavioural change theories [
69], where patients face their individual challenges using an exploratory approach and actively participate in tasks during both the education and exercise sessions.
These elements could have been introduced in different ways. We chose to adapt the framework of the GLA:D program for knee and hip pain because this framework has been successful and is well known to clinicians in Denmark [
5]. The GLA:D framework includes three mandatory elements: 1) a course for clinicians, 2) education and supervised exercise for patients and 3) evaluation using data gathered via a registry.
The GLA:D Back program is a generic care package potentially implementable in different health systems. Similar principles have been applied in the Swedish BetterBack☺ model of care [
13] and the Horizon 2020 project
selfBACK (Svendsen MJ, Sandal LF, Kjaer P, Nicholl BI, Cooper K, Holtermann A, Mair FS, Hartvigsen J, Stochkendahl MJ, Sogaard K et al: Intervention mapping for developing an app-based decision support system to improve self-management of non-specific low back pain (SELFBACK), in preparation) [
12], which provide potential for comparing future research outcomes. However, the content of the BetterBack☺ model of care is specifically adapted to the Swedish health care system while the
selfBACK intervention is delivered using smartphone technology.
Other studies have already developed self-management programs that target psychosocial factors in chronic low back pain, for example, `Back on Track´ [
140], and for osteoarthritis and low back pain in the `SOLAS´ study [
141]. Both studies have outlined comprehensive theory for their intervention components with particular focus on education that addresses modifiable risk factors. Clinical trials are planned in both studies [
142,
143] but so far, we have only seen promising results from the feasibility of the clinician training [
144]. These studies inform and support our development of the GLA:D Back intervention. However, we believe that stronger integration between the theoretical components of patient education and performing higher dose individualised exercises will improve the probability of success with our intervention.
There is no generally agreed instrument designed to measure self-management. However, a very recent review identified 14 different proxy measures in 25 RCTs for self-management of which self-efficacy was the most common [
145], although self-efficacy and self-management are different constructs.
GLA:D Back is built on the best available and generally recommended evidence for the management of people with persistent or recurrent back pain [
1]. All the components of education, exercise and cognitive approaches included in GLA:D Back have been evaluated and found effective in numerous clinical trials. GLA:D Back has not been tested for effectiveness in a randomised clinical trial prior to implementation in Denmark but we have set up an ambitious implementation and evaluation plan to document the effects for individuals and society (Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J: GLA:D® Back: Implementation of group-based patient education integrated with exercises to support self-management of back pain. Protocol for a hybrid effectiveness-implementation study, submitted). Furthermore, plans for randomised controlled trials are underway in Canada and Australia and these will, together with the implementation and outcomes research, inform future revisions and modifications of the program.
Acknowledgements
We would like to acknowledge Associate Professor Lotte O’Neill from the SDU Centre for Teaching and Learning for her input to defining learning goals and evaluating the clinician course. The selfBACK project (European Union Horizon 2020 research and innovation programme, grant agreement No. 689043) is acknowledged for sharing its resources in the development of GLA:D Back, and in particular Louise Fleng Sandal and Line Thomassen for their responsibilities in developing and recording the exercise components. We also acknowledge the multidisciplinary expert group whose members are:
Paul Jarle Mork, Department of Public Health and Nursing at the Norwegian University of Science and Technology, Trondheim, Norway.
Karen Søgaard, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark.
Line Thomassen, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark.
Thomas Bredal, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark.
Rikke Krüger Jensen, Nordic Institute of Chiropractic and Clinical Biomechanics, Denmark.
Lars Morso, Centre for Quality, Region of Southern Denmark, Denmark.
Greg Kawchuk, Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Canada.
Lisbeth Hartvigsen, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark.
Malene Jagd Svendsen, National Research Centre for the Working Environment, Copenhagen, Denmark.
All authors of this manuscript were members of this group.
Finally, the GLA:D Back advisory group is acknowledged for its input to the project. Its members are:
Professor Ewa M Roos, Centre for Muscle and Joint Health, SDU, Denmark.
Professor Birgitta Öberg, Department of Medical and Health Sciences, Linköping University, Sweden.
Director and research leader Henrik Wulff Christensen, Nordic Institute of Chiropractic and Clinical Biomechanics, Denmark.
Associate Professor Christian von Plessen, Centre for Quality, Region of Southern Denmark, Denmark.
Professor Jens Søndergaard, Research Unit for General Practice, University of Southern Denmark, Denmark.
Associate Professor Søren T Skou, Centre for Muscle and Joint Health, University of Southern Denmark, Denmark.
Professor Bart Koes, Department of General Practice, Erasmus MC, The Netherlands.
Professor Chris Maher, Sydney School of Public Health, The University of Sydney, Australia.
Professor Berit Schiøttz-Christensen, The Spine Centre of Southern Denmark, Denmark.
Associate Professor Tonny Andersen, Department of Psychology, University of Southern Denmark, Denmark.
Business Developer Lars Stig Møller, University of Southern Denmark IRO, Denmark.
Professor Per Nilsen, Department of Medical and Health Sciences, Linköping University, Sweden.
Werner Vach, Department of Orthopedics and Traumatology, University Hospital Basel, Switzerland.