Risks, solutions and implementation of a participatory ergonomic intervention in 16 day nurseries: A process evaluation of the TOY wait-list cluster-randomized controlled trial.

More evidence-based initiatives to reduce physical work demands during childcare work to prevent ill health and promote the ability to care for the children among childcare workers are needed. In a process evaluation performed alongside a two-arm, cluster-randomized study with a waiting-list control among 16 day nurseries lasting 20-weeks that significantly reduced musculoskeletal pain-related sickness absence we investigated 1) risk factors and solutions perceived by the childcare workers, and 2) implementation of the intervention. Most of the perceived risk factors were categorized as physical (70 %) with most of the suggested solutions also being categorized as physical (61 %). The remaining risk factors were categorized as organizational risk factors (16 %) and psychosocial risk factors (13 %). The remaining solutions were distributed almost equally between the organizational (20 %) and psychosocial categories (19 %). About half (51 %) of the action plans showed high implementation success. Of 16 workshops, 100 % were delivered with a fidelity of 83 %. Average participation, exposure, responsiveness and implementation were 68 %, 56 %, 83 % and 47 %. The implementation score differed for timing of intervention but not for nursery characteristics. This study showed that complex and diverse participatory ergonomic interventions should focus on physical, organizational and psychosocial factors to have a positive effect.

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 >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.

Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial.

Importance: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. Objective: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. Design, Setting, and Participants: This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. Interventions: The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. Main Outcomes and Measures: Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. Results: A total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01). Conclusions and Relevance: Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. Trial Registration: ClinicalTrials.gov Identifier: NCT03798288.

Developing a practice and evidence-based guideline for occupational health and safety professionals to prevent and handle musculoskeletal pain in workplaces.

Practice guidelines can facilitate the translation of evidence-based knowledge into better occupational health and safety (OHS) prevention. This paper describes the development process, findings and content of a practice and evidence-based guideline for musculoskeletal pain (MSP) to OHS professionals in Denmark. We used a participatory process with involvement of more than 100 OHS professionals in the development of the guideline. The guideline contains three sections: 1) Rapid review of risk factors for MSP (Push/pull, Screen work, Lifting, Awkward postures and Psychosocial factors related to MSP) and single- and multi-stranded interventions targeting MSP. 2) Process recommendations for use of the guideline by a three-phase participatory process 3) Practical recommendations that contain advice and methods for the three-phase participatory process. This paper can promote future guideline development, as it provides specific insight into how OHS professionals can be included in the development of practice and evidence-based guideline through a participatory process.

Barriers and facilitators to patient uptake and utilisation of digital interventions for the self-management of low back pain: a systematic review of qualitative studies.

OBJECTIVES: Low back pain (LBP) is a leading contributor to disability globally. Self-management is a core component of LBP management. We aimed to synthesise published qualitative literature concerning digital health interventions (DHIs) to support LBP self-management to: (1) determine engagement strategies, (2) identify barriers and facilitators affecting patient uptake/utilisation and (3) develop a preliminary conceptual model of barriers and facilitators to uptake/utilisation. DESIGN: Systematic review following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. DATA SOURCES: MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER, TRoPHI, Web of Science and OT Seeker, from January 2000 to December 2018, using the concepts: LBP, DHI and self-management. ELIGIBILITY CRITERIA: Peer-reviewed qualitative study (or component) examining engagement with, or barriers and/or facilitators to the uptake/utilisation of an interactive DHI for self-management of LBP in adults (community, primary or secondary care settings). DATA EXTRACTION AND SYNTHESIS: Standardised data extraction form was completed. COREQ (Consolidated criteria for Reporting Qualitative research) checklist was used to assess methodology. Data was synthesised narratively for engagement strategies, thematically for barriers/facilitators to uptake/utilisation and normalisation process theory was applied to produce a conceptual model. RESULTS: We identified 14 191 citations, of which 105 full-text articles were screened, and five full-text articles from four studies included. These were from community and primary care contexts in Europe and the USA, and involved 56 adults with LBP and 19 healthcare professionals. There was a lack of consideration on how to sustain engagement with DHIs. Examination of barriers and facilitators for uptake/utilisation identified four major themes: IT (information technology) usability-accessibility; quality-quantity of content; tailoring-personalisation; and motivation-support. These themes informed the development of a preliminary conceptual model for uptake/utilisation of a DHI for LBP self-management. CONCLUSIONS: We highlight key barriers and facilitators that should be considered when designing DHIs for LBP self-management. Our findings are in keeping with reviews of DHIs for other long-term conditions, implying these findings may not be condition specific. SYSTEMATIC REVIEW REGISTRATION: A protocol for this systematic review was registered with https://www.crd.york.ac.uk/PROSPERO/ (CRD42016051182) on 10 November 2016. https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016051182.

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.

Inter-Rater Reliability of Ergonomic Work Demands for Childcare Workers Using the Observation Instrument TRACK.

The aim of this study is to evaluate the inter-rater reliability of a newly developed instrument-TRACK (observaTion woRk demAnds Childcare worK) for observations of ergonomic work demands in childcare work. Two trained raters conducted thirty hours of concurrent observation of fifteen childcare workers in three different day nurseries. Inter-rater reliability of ergonomic work demands was evaluated using Gwet's Agreement Coefficient (AC1) and interpreted by the Landis and Koch benchmark scale. Twenty ergonomic work demand items were evaluated. Inter-rater reliability was 'almost perfect' for nine items (AC1 0.81-1.00), 'substantial' for four items (AC1 0.61-0.80), 'moderate' for four items (AC1 0.41-0.60), 'fair' for two items (AC1 0.21-0.40), and 'slight' (AC1 0.00-0.20) for one item. No items had 'poor' (AC1 < 0.00) agreement. The instrument is reliable for assessing ergonomic work demands in childcare in real-life settings.

An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial.

BACKGROUND: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. OBJECTIVE: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. METHODS: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. RESULTS: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. CONCLUSIONS: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. TRIAL REGISTRATION: ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14720.

Improving work for the body - a participatory ergonomic intervention aiming at reducing physical exertion and musculoskeletal pain among childcare workers (the TOY-project): study protocol for a wait-list cluster-randomized controlled trial.

BACKGROUND: The prevalence of musculoskeletal pain (MSP) is persistently high throughout the world. Work-related factors such as high physical workload (lifting, bending and twisting of the back) are considered to be among the main causes of MSP. Work in childcare includes the need to lift, carry, and support children in a range of activities, requiring several demanding postures and movements, such as bending forward and twisting of the back and sitting on the floor. Participatory ergonomics may represent a solution for decreasing the physical workload to reduce MSP. We present the protocol of a study aiming to evaluate the effect and process of a participatory ergonomics intervention designed to reduce physical exertion during work and MSP (including MSP interfering with work) among childcare workers. METHODS/DESIGN: This study will use a two-arm cluster-randomized design employing a wait-list control, with childcare institutions forming the clusters. Three workshops will be conducted during the 4-month intervention period. Participants will identify risk factors for strenuous work and MSP, develop solutions for reducing the identified risk factors, and implement them in their team. An ergonomic consultant will guide the process. The data collection will consist of questionnaires and objective measures of heart rate and physical activity, observations of physical workload, and information on sickness absence based on company records. Primary outcomes are physical exertion during work and MSP (including pain-related work interference) measured at 4 months. Secondary outcomes measured at 4 months are sickness absence due to MSP; objectively measured occupational physical activity and heart rate; and self-reported self-efficacy, employee involvement, and need for recovery. Alongside the trial, a process evaluation and an economic evaluation will be conducted. DISCUSSION: The study will evaluate the effect and process of a participatory ergonomics intervention to reduce physical exertion at work and MSP among childcare workers. By performing a cluster-randomized controlled trial with an effect evaluation based on both objective and self-reported measures with the addition of a process evaluation and economic evaluation, this study will contribute to the evidence for prevention of MSP among a less studied occupational group. Results are expected in 2018-2019. TRIAL REGISTRATION: ISRCTN, ISRCTN10928313 . Registered on 11 January 2017.