Design of a clinician dashboard to facilitate co-decision making in the management of non-specific low back pain

This paper presents the design of a Clinician Dashboard to promote co-decision making between patients and clinicians. Targeted patients are those with non-specific low back pain, a leading cause of discomfort, disability and absence from work throughout the world. Targeted clinicians are those in primary care, including general practitioners, physiotherapists, and chiropractors. Here, the functional specifications for the Clinical Dashboard are delineated, and wireframes illustrating the system interface and flow of control are shown. Representative scenarios are presented to exemplify how the system could be used for co-decision making by a patient and clinician. Also included are a discussion of potential barriers to implementation and use in clinical practice and a look ahead to future work. This work has been conducted as part of the Horizon 2020 selfBACK project, which is funded by the European Commission

Usability and acceptability of an app (SELFBACK) to support self-management of low back pain: mixed methods study.

Self-management is the key recommendation for managing non-specific low back pain (LBP). However, there are well-documented barriers to self-management, therefore methods of facilitating adherence are required. Smartphone apps are increasingly being used to provide feedback and reinforcement to support self-management of long-term conditions such as LBP. The aim of this study was to assess the usability and acceptability of the selfBACK smartphone app, designed to support and facilitate self-management of non-specific LBP. The app provides weekly self-management plans, comprising physical activity, strength/flexibility exercises, and patient education. The plans are tailored to the patient's characteristics and symptom progress by using case-based reasoning methodology. The study was carried out in two stages, using a mixed-methods approach. All participants undertook surveys and semi-structured telephone interviews were conducted with a subgroup of participants. Stage 1 assessed an app version with only the physical activity component and a web-questionnaire that collects information necessary for tailoring the self-management plans. The physical activity component included monitoring of steps recorded by a wristband, goal-setting, and a scheme for sending personalised, timely and motivational notifications to the user's smartphone. Findings from stage 1 were used to refine the app and inform further development. Stage 2 investigated an app version that incorporated three self-management components (physical activity, exercises and education). A total of sixteen participants (age range 23-71 years) with ongoing or chronic non-specific LBP were included in stage 1, and eleven participants (age range 32-56) were included in stage 2. In stage 1, 94% of participants reported that the baseline questionnaire was easy to answer and 84% found completion time to be acceptable. Overall, participants were positive about the usability of the physical activity component but only 31% found the app functions to be well integrated. 90% of the participants were satisfied with the notifications and 80% perceived the notifications to be personalised. In stage 2, all participants reported that the web-questionnaire was easy to answer and the completion time acceptable. The physical activity and exercise components were rated useful by 80%, while 60% rated the educational component useful. Overall, participants were satisfied with the usability of the app; however, only 50% found the functions to be well integrated and 20% found them to be inconsistent. Overall, 80% of participants reported it to be useful for self-management. The interviews largely reinforced the survey findings in both stages. This study has demonstrated that participants considered the selfBACK app to be acceptable and usable, and that they thought it would be useful for supporting self-management of LBP. However, we identified some limitations and suggestions, which will be useful in guiding further development of the selfBACK app and other mHealth interventions

Interplay between chronic widespread pain and lifestyle factors on the risk of type 2 diabetes: longitudinal data from the Norwegian HUNT Study

Introduction Chronic widespread pain (CWP) and diabetes commonly co-occur; however, it is unclear whether CWP infers an additional risk for diabetes among those with known risk factors for type 2 diabetes. We aimed to examine if CWP magnifies the effect of adverse lifestyle factors on the risk of diabetes. Research design and methods The study comprised data on 25 528 adults in the Norwegian HUNT Study without diabetes at baseline (2006–2008). We calculated adjusted risk ratios (RRs) with 95% CIs for diabetes at follow-up (2017–2019), associated with CWP and body mass index (BMI), physical activity, and insomnia symptoms. The relative excess risk due to interaction (RERI) was calculated to investigate the synergistic effect between CWP and adverse lifestyle factors. Results Compared with the reference group without chronic pain and no adverse lifestyle factors, those with BMI ≥30 kg/m2 with and without CWP had RRs for diabetes of 10.85 (95% CI 7.83 to 15.05) and 8.87 (95% CI 6.49 to 12.12), respectively; those with physical activity <2 hours/ week with and without CWP had RRs for diabetes of 2.26 (95% CI 1.78 to 2.88) and 1.54 (95% CI 1.24 to 1.93), respectively; and those with insomnia symptoms with and without CWP had RRs for diabetes of 1.31 (95% CI 1.07 to 1.60) and 1.27 (95% CI 1.04 to 1.56), respectively. There was little evidence of synergistic effect between CWP and BMI ≥30 kg/m2 (RERI=1.66, 95%CI −0.44 to 3.76), low physical activity (RERI=0.37, 95%CI −0.29 to 1.03) or insomnia symptoms (RERI=−0.09, 95%CI −0.51 to 0.34) on the risk of diabetes. Conclusions These findings show no clear interaction between CWP and adverse lifestyle factors on the risk of diabetes

Health-related quality of life in young adults born small for gestational age : a prospective cohort study

Background Individuals born small for gestational age (SGA) have an increased risk of several adverse health outcomes, but their health-related quality of life (HRQoL) across young adulthood has yet to be studied. The main aim of this study was to investigate if being born SGA at term is associated with poor HRQoL at 32 years of age. A second aim was to explore longitudinal changes in HRQoL from age 20 to 32 years. Methods In the prospective NTNU Low Birth Weight in a Lifetime Perspective study, 56 participants born SGA and 68 non-SGA control participants completed the Short Form 36 Health Survey (SF-36) at age 32 years to assess HRQoL. The SF-36 was also administrated at age 20 and 28 years. Longitudinal changes in the eight SF-36 domains and the two component summaries from 20 to 32 years were analyzed by linear mixed models. In total, 82 adults born SGA and 98 controls participated at least once and were included in the longitudinal analyses. Results At age 32 years the participants born SGA scored 14.8 (95% CI 4.7 to 25.3) points lower in the SF-36 role-physical domain compared with the control group, i.e. more problems with work or other daily activities due to physical health problems. The longitudinal analyses showed significant group differences from 20 to 32 years in the role-emotional domain, and in the physical and mental component summaries. Among participants born SGA, the physical component summary decreased from age 20 to 28 years (-3.2, 95% CI -5.0 to -1.8), while the mental component summary (6.0, 95% CI 2.9 to 8.6) and role-emotional domain score (19.3, 95% CI 9.9 to 30.3) increased, but there were no further changes from 28 to 32 years. There were no longitudinal changes in the control group from 20 to 32 years. Conclusion Overall, individuals born SGA at term reported similar HRQoL at age 32 years compared with non-SGA controls. Self-perceived mental health improved during young adulthood among individuals born SGA, while self-perceived physical health deteriorated. The latter findings warrant further investigation.Peer reviewe

Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial

Background Sexual assault and rape are the traumatic life events with the highest probability for posttraumatic stress disorder (PTSD), which can have devastating consequences for those aficted by the condition. Studies indicate that modifed prolonged exposure (mPE) therapy may be efective in preventing the development of PTSD in recently traumatized individuals, and especially for people who have experienced sexual assault. If a brief, manualized early intervention can prevent or reduce post-traumatic symptoms in women who have recently experienced rape, healthcare services targeted for these populations (i.e., sexual assault centers, SACs) should consider implementing such interventions as part of routine care. Methods/design This is a multicenter randomized controlled add-on superiority trial that enrolls patients attending sexual assault centers within 72 h after rape or attempted rape. The objective is to assess whether mPE shortly after rape can prevent the development of post-traumatic stress symptoms. Patients will be randomized to either mPE plus treatment as usual (TAU) or TAU alone. The primary outcome is the development of post-traumatic stress symptoms 3 months after trauma. Secondary outcomes will be symptoms of depression, sleep difculties, pelvic foor hyperactivity, and sexual dysfunction. The frst 22 subjects will constitute an internal pilot trial to test acceptance of the intervention and feasibility of the assessment battery. Discussion This study will guide further research and clinical initiatives for implementing strategies for preventing post-traumatic stress symptoms after rape and provide new knowledge about which women may beneft the most from such initiatives and for revising existing treatment guidelines within this area

App-delivered self-management intervention trial selfBACK for people with low back pain: protocol for implementation and process evaluation

Background: Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. Objective: This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. Methods: The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. Results: The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. Conclusions: This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. Trial Registration: ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID): DERR1-10.2196/20308

Using intervention mapping to develop a decision support system–based smartphone app (selfBACK) to support self-management of nonspecific low back pain: development and usability study

Background: International guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions. Objective: The aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability. Methods: The first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of &gt;2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study. Results: A behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory. Conclusions: We describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management