Dataset Information

Adherence and characteristics of participants enrolled in a standardised programme of patient education and exercises for low back pain, GLA:D® Back - a prospective observational study.

ABSTRACT:

Background

Low back pain is often long-lasting, and implementation of low-cost interventions to improve care and minimise its burden is needed. GLA:D® Back is an evidence-based programme consisting of patient education and supervised exercises for people with low back pain, which was implemented nationwide in primary care clinics in Denmark. To assess how the intervention was received and factors influencing adherence to the program, we aimed to evaluate participants' adherence to the intervention and identified characteristics related to the completion of GLA:D® Back. Specifically, we investigated: 1) level of attendance of participants enrolled in the programme, and 2) participant-related factors associated with low attendance.

Methods

Primary care clinicians delivered GLA:D® Back, a standardised 10-week programme of 2 educational and 16 supervised exercise sessions, to patients with low back pain. Attendance was defined as low, medium or high based on self-reported number of attended sessions. Additional participant-reported data included demographic characteristics, pain, prognostic risk profiles, self-efficacy, illness-beliefs, function and clinician-reported physical performance tests. Results for high, medium, low, and unknown attendance were reported descriptively. Odds ratios for low attendance compared to medium/high attendance were calculated by including all baseline factors in a mixed-model logistic regression model.

Results

Of 1730 participants, 52% had high, 23% medium, and 25% low levels of attendance. Level of attendance was not strongly associated with participants' individual factors, but in combination, prediction of low attendance was fair (AUC 0.77; 95% CI 0.74-0.79). The strongest indicator of low attendance was not completing the baseline questionnaire.

Conclusions

Most participants of a 10-week low back pain programme attended almost all session. Non-response to the baseline questionnaire was strongly associated with low attendance, whereas individual patient characteristics were weakly related to attendance. Not completing baseline questionnaires might be an early indicator of poor adherence in programs for people with persistent low back pain.

Trial registration

The Health Research Ethics for Southern Denmark decided there was no need for ethical approval (S-20172000-93). The Danish data collection has obtained authorisation from the Danish Data Protection Agency as part of the University of Southern Denmark's institutional authorisation (DPA no. 2015-57-0008 SDU no. 17/30591). The trial was registred at ClinicalTrials.gov NCT03570463 .

SUBMITTER: Ris I

PROVIDER: S-EPMC8141215 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundClinical guidelines for management of low back pain (LBP) are not routinely implemented in practice, and guidelines rarely offer tools for implementation. Therefore, we developed GLA:D® Back, a standardised intervention of patient education and supervised exercises. This pilot study tested the feasibility of implementing GLA:D Back in clinical practice in Denmark by delivering a course for physiotherapists and chiropractors. It should further inform the planning of an implementation-effectiveness study using a pre-post group design alongside nation-wide implementation.MethodsThirty-one clinicians from nine clinics participated. Feasibility of implementation was evaluated in terms of adoption and through focus group interviews and a feedback meeting. Patient-level data, including pain, disability, and pain enablement, were collected from (1) LBP patients visiting the clinics during a pre-specified 2-week period 2 months prior to clinicians attending the GLA:D Back course (n = 84), (2) LBP patients consulting during a 2-week period 2 months after the course (n = 77), and (3) those enrolled in GLA:D Back during 4 months after implementation (n = 89). Patient data were collected at baseline and at 4 months.ResultsClinicians' evaluations of the course were positive and resulted in several modifications. The clinical intervention was adopted by all test sites. Most patient characteristics were similar across groups. Patients mainly had persistent LBP (73% > 3 months) and most had been treated for more than 4 weeks at inclusion. Patients in GLA:D Back were more often retired (30% vs. 16% before implementation) and at high risk of poor prognosis (25% vs. 13%). Procedures for data collection were feasible, and outcomes after implementation, especially with GLA:D Back, were as good as or better than before implementation. Recruiting patients and achieving comparable pre- and post-groups was difficult.ConclusionsImplementation of the GLA:D Back clinical intervention in Danish primary care physiotherapy and chiropractic clinics was feasible through a 2-day clinician course. Both clinicians and patients were satisfied with the programme, and patient-reported outcomes were slightly better than outcomes in patients registered before implementation. It was not deemed possible to conduct an implementation-effectiveness trial as part of a nation-wide implementation.

Project description:BackgroundClinical guidelines recommend that people with back pain be given information and education about their back pain, advice to remain active and at work, and exercises to improve mobility and physical activity. Guidelines, however, rarely describe how this is best delivered. The aim of this paper is to present the development, theories, and underlying evidence for 'GLA:D Back' - a group education and exercise program that translates guideline recommendations into a clinician-delivered program for the promotion of self-management in people with persistent/recurrent back pain.MethodsGLA:D Back, which included a rationale and objectives for the program, theory and evidence for the interventions, and program materials, was developed using an iterative process. The content of patient education and exercise programs tested in randomised trials was extracted and a multidisciplinary team of expert researchers and clinicians prioritised common elements hypothesised to improve back pain beliefs and management skills. The program was tested on eight people with persistent back pain in a university clinic and 152 patients from nine primary care physiotherapy and chiropractic clinics. Following feedback from the clinicians and patients involved, the working version of the program was created.ResultsEducational components included pain mechanisms, pain modulation, active coping strategies, imaging, physical activity, and exercise that emphasised a balance between the sum of demands and the individual's capacity. These were operationalised in PowerPoint presentations with supporting text to aid clinicians in delivering two one-hour patient education lectures. The exercise program included 16 supervised one-hour sessions over 8 weeks, each comprising a warm-up section and eight types of exercises for general flexibility and strengthening of six different muscle groups at four levels of difficulty. The aims of the exercises were to improve overall back fitness and, at the same time, encourage patients to explore variations in movement by incorporating education content into the exercise sessions.ConclusionFrom current best evidence about prognostic factors in back pain and effective treatments for back pain, research and clinical experts developed a ready-to-use structured program - GLA:D® Back - to support self-management for people with persistent/recurrent back pain.

Project description:BackgroundReassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel.MethodsThe main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave.DiscussionThis implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice.Trial registrationClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Project description:BackgroundPractice-based guidelines recommend patient education and exercise as first-line care for low back pain (LBP); however, these recommendations are not routinely delivered in practice. GLA:D® Back, developed in Denmark to assist clinicians to implement guideline recommendations, offers a structured education and supervised exercise program for people with LBP in addition to a clinical registry to evaluate patient outcomes. In this study we evaluated the feasibility of implementing the GLA:D® Back program in Australia. We considered clinician and patient recruitment and retention, program fidelity, exploring clinicians' and patients' experiences with the program, and participant outcome data collection.MethodsClinicians (chiropractors and physiotherapists) were recruited and participated in a 2-day GLA:D® Back training course. Patients were eligible to participate if they had persistent or recurrent LBP. Feasibility domains included the ability to: (1) recruit clinicians to undergo training; (2) recruit and retain patients in the program; (3) observe program fidelity; and (4) perceive barriers and facilitators for GLA:D® Back implementation. We also collected data related to: (5) clinician confidence, attitudes, and behaviour; and (6) patient self-reported outcomes related to pain, disability, and performance tests.ResultsTwenty clinicians (8 chiropractors, 12 physiotherapists) participated in the training, with 55% (11/20) offering GLA:D® Back to their patients. Fifty-seven patients were enrolled in the program, with 67% (38/57) attending the final follow-up assessment. Loss to follow up was mainly due to the effects of the COVID-19 pandemic. We observed program fidelity, with clinicians generally delivering the program as intended. Interviews revealed two clinician themes related to: (i) intervention acceptability; and (ii) barriers and facilitators to implementation. Patient interviews revealed themes related to: (i) intervention acceptability; and (ii) program efficacy. At 3 months follow-up, clinicians demonstrated high treatment confidence and biomedical orientation. Patient outcomes trended towards improvement.ConclusionGLA:D® Back implementation in Australia appears feasible based on clinician recruitment, program acceptability and potential benefits for patient outcomes from the small sample of participating clinicians and patients. However, COVID-19 impacted patient recruitment, retention, and data collection. To scale-up GLA:D® Back in private and public settings, further work is warranted to address associated barriers, and to leverage facilitators.

Project description:BackgroundCurrent evidence supports the use of exercise-based treatment for chronic low back pain that encourages the patient to assume an active role in their recovery. Walking has been shown it to be an acceptable type of exercise with a low risk of injury. However, it is not known whether structured physical activity programmes are any more effective than giving advice to remain active.Methods/designThe proposed study will test the feasibility of using a pedometer-driven walking programme, as an adjunct to a standard education and advice session in participants with chronic low back pain. Fifty adult participants will be recruited via a number of different sources. Baseline outcome measures including self reported function; objective physical activity levels; fear-avoidance beliefs and health-related quality of life will be recorded. Eligible participants will be randomly allocated under strict, double blind conditions to one of two treatments groups. Participants in group A will receive a single education and advice session with a physiotherapist based on the content of the 'Back Book'. Participants in group B will receive the same education and advice session. In addition, they will also receive a graded pedometer-driven walking programme prescribed by the physiotherapist. Follow up outcomes will be recorded by the same researcher, who will remain blinded to group allocation, at eight weeks and six months post randomisation. A qualitative exploration of participants' perception of walking will also be examined by use of focus groups at the end of the intervention. As a feasibility study, treatment effects will be represented by point estimates and confidence intervals. The assessment of participant satisfaction will be tabulated, as will adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists. This information will be used to modify the planned interventions to be used in a larger randomised controlled trial.DiscussionThis paper describes the rationale and design of a study which will test the feasibility of using a structured, pedometer-driven walking programme in participants with chronic low back pain.Trial registration[ISRCTN67030896].

Project description:BackgroundThe Good Life with osteoArthritis in Denmark (GLA:D®) program was implemented in Canada in 2017 with the aim of making treatment guideline-recommended care available to the 4 million Canadians with knee and hip osteoarthritis (OA). This report describes the GLA:D® Canada program, registry and data collection procedures, and summarizes the sociodemographic and clinical profile of participants with knee and hip OA to inform the scientific research community of the availability of these data for future investigations and collaborations.MethodsThe GLA:D® program consists of three standardized components: a training course for health care providers, a group-based patient education and exercise therapy program, and a participant data registry. Patients seeking care for knee or hip OA symptoms and enrolling in GLA:D® are given the option to provide data to the GLA:D® Canada registry. Participants agreeing to provide data complete a pre-program survey and are followed up after 3-, and 12-months. Data collected on the pre-program and follow-up surveys include sociodemographic factors, clinical characteristics, health status measures, and objective physical function tests. These variables were selected to capture information across relevant health constructs and for future research investigations.ResultsAt 2022 year-end, a total of 15,193 (11,228 knee; 3,965 hip) participants were included in the GLA:D® Canada registry with 7,527 (knee; 67.0%) and 2,798 (hip; 70.6%) providing pre-program data. Participants were 66 years of age on average, predominately female, and overweight or obese. Typically, participants had knee or hip problems for multiple years prior to initiating GLA:D®, multiple symptomatic knee and hip joints, and at least one medical comorbidity. Before starting the program, the average pain intensity was 5 out of 10, with approximately 2 out of 3 participants using pain medication and 1 in 3 participants reporting a desire to have joint surgery. Likewise, 9 out 10 participants report having previously been given a diagnosis of OA, with 9 out 10 also reporting having had a radiograph, of which approximately 87% reported the radiograph showed signs of OA.ConclusionWe have described the GLA:D® Canada program, registry and data collection procedures, and provided a detailed summary to date of the profiles of participants with knee and hip OA. These individual participant data have the potential to be linked with local health administrative data registries and comparatively assessed with other international GLA:D® registries. Researchers are invited to make use of these rich datasets and participate in collaborative endeavours to tackle questions of Canadian and global importance for a large and growing clinical population of individuals with hip and knee OA.

Project description:Study designSystematic review of Randomised controlled trials.ObjectivesWith the increasing incidence of back pain among children and its untold implications to their future, back education tailored in an effective way would be indicated. However literature appears unsettled. This study aims to review available literature to determine the effect of school-based back education in preventing and managing low back pain in school children.MethodsRandomized controlled trials carried out on elementary and secondary school children of ages 6 to 18 years and published in English language were included. Back education taught in hospitals or other settings were excluded. Primary outcome was back pain prevalence and secondary outcomes were constituted from the study characteristics of selected studies which includes: back behavior, knowledge, postural habits, physical activity, fear-avoidance beliefs, back pack carriage, pain intensity, skills and self efficacy. Databases searched were PEDro, HINARI, PubMed, Cochrane, and Google Scholar. Available stiudies from 2000 to March 2022 were retrieved. Quality of studies were assessed using the PEDro scale. Obtained studies were descriptively analyzed.ResultsA total 8420 studies were retrieved and 8 studies (with 1239 participants) were included in this review. Four studies each assessed back knowledge and back behavior, and two assessed back pain prevalence. There were improvements in back knowledge and back behaviour, but effectiveness of back care education on back pain prevalence was not conclusive. Forms of education used involved the indirect method of conditioning the environment and the direct method which made use of theory, practical lessons and educational books and materials.ConclusionBack care education programmes in schools are effective in improving back care knowledge, behavior and reduction in low back pain frequency. Reduction in back pain prevalence is not conclusive. Back care education could be incorporated as part of schools' education programmes. Limitations include exclusion of non English language studies and inconsistent outcome measures.Funding sourceNone.RegistrationThis review protocol was registered under the International platform of Registered systematic review and meta-analysis protocol (INPLASY) with the registration number; INPLASY202310044 and DOI number; https://doi.org/10.37766/inplasy2023.1.0044.

Project description:BackgroundOsteoarthritis (OA) affecting the knee or hip is highly prevalent in the general population and has associated high disease burden. Early identification of modifiable risk factors that prevent, limit, or resolve disease symptoms is critical. Foot pain may represent a potentially modifiable factor however little is known about the prevalence of foot pain in people with knee or hip OA nor whether foot pain is associated with clinical characteristics. The main aim of this study was therefore to determine the prevalence of foot pain in people with knee or hip OA attending an education and supervised exercise-based intervention in Denmark (GLA:D®) and determine if baseline demographic or clinical characteristics are associated with foot pain.MethodsAnalysis was conducted on baseline data of 26,003 people with symptomatic knee or hip OA completing a pain mannequin as part of the Good Life with osteoArthritis in Denmark (GLA:D®) primary care programme. Odds Ratios (OR) and 95% confidence intervals (CI) were calculated to estimate the strength of association between baseline clinical characteristics (including pain severity in worst knee/hip joint, number of painful knee/hip joints, pain medication use and physical activity level) and the presence of baseline foot pain.ResultsTwelve percent of participants (n = 3,049) reported foot pain. In those people with index knee OA (n = 19,391), knee pain severity (OR 1.01 CI 1.00, 1.01), number of painful knee/hip joints (OR 1.67 CI 1.58, 1.79), and use of pain medication (OR 1.23 CI 1.12, 1.36) were statistically associated with foot pain. Excluding use of pain medication, similar associations were seen in those with index hip OA.ConclusionTwelve percent of people with knee or hip OA participating in GLA:D® had foot pain. Those with worse knee/hip pain, and greater number of painful joints were more likely to report foot pain. This study is the first to demonstrate a significant relationship between clinical characteristics and foot pain in people with knee or hip OA participating in education and supervised exercise. Future investigation should consider the role that foot pain may play on knee and hip related outcomes following therapeutic intervention.

Project description:ObjectivePost-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi.Key pointsIncluding all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocation to trial arm. Ineligible participants are sometimes enrolled, due to measurement or human error. Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria. We assumed no safety risk of azithromycin treatment; their inclusion in the trial and subsequent analysis of the intervention effect therefore mirrors clinical practice. Senior trial investigators considered diurnal variations in the measurement of lung function, advantages of retaining a higher sample size and advice from the Data Safety and Monitoring Board and Trial Steering Committee, and decided to include these participants in primary analysis. We planned and reported analyses including and excluding these participants, and in our case the interpretation of treatment effect was consistent.ConclusionThe decision, by senior investigators, on whether to exclude enrolled participants, should reflect issues of safety, treatment efficacy, statistical power and measurement error. As long as decisions are made prior to finalising the statistical analysis plan for the trial, the risk of exclusions creating bias should be minimal. The decision taken should be transparently reported and a sensitivity analysis can present the opposite decision.