Inclusion and exclusion criteria used in non-specific low back pain trials: a review of randomised controlled trials published between 2006 and 2012.

BACKGROUND: Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of treatments for nsLBP. METHODS: A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, using a mixed-methods approach to analysis. Study inclusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category. RESULTS: We included 168 studies. Two inclusion themes (anatomical area, and symptoms and signs) were identified. Anatomical area was most reported as between costal margins and gluteal folds (n = 8, 5%), while low back pain (n = 150, 89%) with or without referred leg pain (n = 27, 16%) was the most reported symptom. Exclusion criteria comprised 21 themes. Previous or scheduled surgery (n = 84, 50%), pregnancy (n = 81, 48%), malignancy (n = 78, 46%), trauma (n = 63, 37%) and psychological conditions (n = 58, 34%) were the most common. Sub-themes of exclusion criteria mostly related to neurological signs and symptoms: nerve root compromise (n = 44, 26%), neurological signs (n = 34, 20%) or disc herniation (n = 30, 18%). Specific conditions that were most often exclusion criteria were spondylolisthesis (n = 35, 21%), spinal stenosis (n = 31, 18%) or osteoporosis (n = 27, 16%). CONCLUSION: RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria. Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses. We propose a template for reporting inclusion and exclusion criteria.

Translation and cultural adaptation of evidence-informed leaflets on the work-health interface: a pragmatic approach to cultural adaptation.

AIM: Our aim was to translate and culturally adapt three evidence-informed leaflets on the work-health interface from English into Norwegian. Integral to this aim was the exploration of the quality and acceptability of each of the adapted leaflets to Norwegian-speaking stakeholders; general practitioners, people who deal with health issues in the workplace, and the general population. BACKGROUND: Common health problems, such as musculoskeletal pain, account for most workdays lost and disability benefits in Norway. To facilitate return to work, it may be important to have access to evidence-informed information on the work-health interface for stakeholders involved in sickness absence processes. However, there is limited information material available in Norwegian that is tailored for the different stakeholders. Cultural adaptation is an emerging strategy for implementing health information across different populations and regions. Guidelines on cultural adaptation are not well-suited for translating and adapting evidence-informed health information material. METHODS: We conducted a pragmatic cultural adaptation process informed by existing guidelines. Our conceptual framework for adaptation is situated between adaptation and translation and comprises appraisal, forward- and back-translation, review in multiple steps, sense checking, and re-designing using a transcreation approach. Using an online survey, we aimed to evaluate the overall quality, value, acceptability, and clarity of each of the adapted leaflets to a total of 30 end-users. FINDINGS: We translated and culturally adapted three leaflets from English to Norwegian. Adapted leaflets were found to be clearly presented, acceptable, and valued by 45 Norwegian end-users. No differences in key concepts between original and back-translated leaflets emerged through the review process by the original author and forward translators. We used a pragmatic approach in this study that might be useful to others culturally adapting evidence-informed health information material.

Individual supported work placements (ReISE) for improving sustained return to work in unemployed people with persistent pain: an internal pilot study of a cohort randomised controlled approach.

BACKGROUND: Persistent pain is a frequent cause of sick leave and work disability in Norway. A return-to-work intervention featuring supported work placements, developed in the UK, demonstrated feasibility, and a return-to-work rate of 20% within 6 months was observed in the sample. We sought to adapt the intervention for delivery in Norway and to confirm feasibility prior to a full-scale trial. METHODS: In this internal pilot, we used a pragmatic cohort randomised controlled approach with national recruitment in Norway. We recruited people who were unemployed (for at least 1 month), having persistent pain (for at least 3 months), aged between 18 and 64, and wanting to return to work. We initially recruited people to an observational cohort study of the impact of being unemployed with persistent pain. After baseline measurement, we randomly sub-sampled participants to whom we offered the intervention, which featured individual case management and support, work-familiarisation sessions, and the offer of a 6-week part-time unpaid work placement. We assessed recruitment rates (aiming to recruit 66, and sub-sample 17 within 6 months); optimal recruitment pathways; intervention acceptance rates; the feasibility of data collection; using video links for work-familiarisation sessions and remote case manager support. RESULTS: The pilot ran from June to November 2022. Of 168 people expressing interest, 94 consented. Recruitment posts on Facebook yielded the most 'expressions of interest' (66%, n = 111). After screening for eligibility, we included 55 participants. Of these, 19 were randomised to be offered the intervention. Of these, less than half (n = 8) consented to intervention participation. Remote case manager and work-familiarisation sessions appeared feasible. Following a delay in identifying placements, three participants received offers of work placements, with one starting and completing during the pilot period. Data collection methods were feasible, and no adverse events were reported. CONCLUSIONS: Recruitment and logistical processes, such as remote management by video link, are feasible. However, delivery of the intervention is challenging. In particular, sourcing placements and the time required for identifying appropriate placements was more challenging than anticipated. A full-scale trial is feasible but will require improvements to the placement identification processes. TRIAL REGISTRATION: ISRCTN85437524 (Referring to the ReISE trial, of which this internal pilot was a part), Registered 31 of May 2022 https://doi.org/10.1186/ISRCTN85437524 TRIAL FUNDING: Norwegian Research Council.

Individual supported work placements (ReISE) for improving sustained return to work in unemployed people with persistent pain: study protocol for a cohort randomised controlled trial with embedded economic and process evaluations.

BACKGROUND: Around one-third of workdays lost in Norway are due to musculoskeletal conditions, with persistent (chronic) pain being the most frequent cause of sick leave and work disability. Increasing work participation for people with persistent pain improves their health, quality of life, and well-being and reduces poverty; however, it is not clear how to best help unemployed people who have persistent pain to return to work. The aim of this study is to examine if a matched work placement intervention featuring case manager support and work-focused healthcare improves return to work rates and quality of life for unemployed people in Norway with persistent pain who want to work. METHODS: We will use a cohort randomised controlled approach to test the effectiveness and cost-effectiveness of a matched work placement intervention featuring case manager support and work-focused healthcare compared to those receiving usual care in the cohort alone. We will recruit people aged 18-64, who have been out of work for at least 1 month, had pain for more than 3 months, and want to work. Initially, all (n = 228) will be recruited to an observational cohort study on the impact of being unemployed with persistent pain. We will then randomly select one in three to be offered the intervention. The primary outcome of sustained return to work will be measured using registry and self-reported data, while secondary outcomes include self-reported levels of health-related quality of life and physical and mental health. Outcomes will be measured at baseline and 3, 6, and 12 months post-randomisation. We will run a process evaluation parallel to the intervention exploring implementation, continuity of the intervention, reasons for participating, declining participation, and mechanisms behind cases of sustained return to work. An economic evaluation of the trial process will also be conducted. DISCUSSION: The ReISE intervention is designed to increase work participation for people with persistent pain. The intervention has the potential to improve work ability by collaboratively navigating obstacles to working. If successful, the intervention may be a viable option for helping people in this population. TRIAL REGISTRATION: ISRCTN Registry 85,437,524 Registered on 30 March 2022.

Opportunities and challenges around adapting supported employment interventions for people with chronic low back pain: modified nominal group technique.

PURPOSE: To identify and rank opportunities and challenges around adapting supported employment interventions for people with chronic low back pain (LBP). METHODS: Delegates from an international back and neck research forum were invited to join an expert panel. A modified nominal group technique (NGT) was used with four stages: silent generation, round robin, clarification, and ranking. Ranked items were reported back and ratified by the panel. RESULTS: Nine experienced researchers working in the fields related to LBP and disability joined the panel. Forty-eight items were generated and grouped into 12 categories of opportunities/challenges. Categories ranked most important related respectively to policy and legislation, ensuring operational integration across different systems, funding interventions, and managing attitudes towards work and health, workplace flexibility, availability of "good" work for this client group, dissonance between client and system aims, timing of interventions, and intervention development. CONCLUSIONS: An expert panel believes the most important opportunities/challenges around adapting supporting employment interventions for people with chronic LBP are facilitating integration/communication between systems and institutions providing intervention components, optimising research outputs for informing policy needs, and encouraging discussion around funding mechanisms for research and interventions. Addressing these factors may help improve the quality and impact of future interventions.Implications for rehabilitationInteraction pathways between health, employment, and social systems need to be improved to effectively deliver intervention components that necessarily span these systems.Research-policy communication needs to be improved by researchers and policy makers, so that research outputs can be consumed by policy makers, and so that researchers recognise the gaps in knowledge needed to underpin policy.Improvements in research-policy communication and coordination would facilitate the delivery of research output at a time when it is likely to make the most impact on policy-making.Discussion and clarification surrounding funding mechanisms for research and interventions may facilitate innovation generally.