Helen Richmond

The Effectiveness of Cognitive Behavioural Treatment for Non-Specific Low Back Pain: A Systematic Review and Meta-Analysis.

Objectives To assess whether cognitive behavioural (CB) approaches improve disability, pain, quality of life and/or work disability for patients with low back pain (LBP) of any duration and of any age. Methods Nine databases were searched for randomised controlled trials (RCTs) from inception to November 2014. Two independent reviewers rated trial quality and extracted trial data. Standardised mean differences (SMD) and 95% confidence intervals were calculated for individual trials. Pooled effect sizes were calculated using a random-effects model for two contrasts: CB versus no treatment (including wait-list and usual care (WL/UC)), and CB versus other guideline-based active treatment (GAT). Results The review included 23 studies with a total of 3359 participants. Of these, the majority studied patients with persistent LBP (>6 weeks; n=20). At long term follow-up, the pooled SMD for the WL/UC comparison was -0.19 (-0.38, 0.01) for disability, and -0.23 (-0.43, -0.04) for pain, in favour of CB. For the GAT comparison, at long term the pooled SMD was -0.83 (-1.46, -0.19) for disability and -0.48 (-0.93, -0.04) for pain, in favour of CB. While trials varied considerably in methodological quality, and in intervention factors such as provider, mode of delivery, dose, duration, and pragmatism, there were several examples of lower intensity, low cost interventions that were effective. Conclusion CB interventions yield long-term improvements in pain, disability and quality of life in comparison to no treatment and other guideline-based active treatments for patients with LBP of any duration and of any age. Systematic Review Registration PROSPERO protocol registration number: CRD42014010536.

Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review

Abstract Purpose: To determine if physiotherapist-led cognitive-behavioural (CB) interventions are effective for low back pain (LBP) and described sufficiently for replication. Method: Randomised controlled trials (RCTs) of patients with LBP treated by physiotherapists using a CB intervention were included. Outcomes of disability, pain, and quality of life were assessed using the GRADE approach. Intervention reporting was assessed using the Template for Intervention Description and Replication. Results: Of 1898 titles, 5 RCTs (n = 1390) were identified. Compared to education and/or exercise interventions, we found high-quality evidence that CB had a greater effect (SMD; 95% CI) on reducing disability (−0.19; −0.32, −0.07), pain (−0.21; −0.33, −0.09); and moderate-quality evidence of little difference in quality of life (−0.06; −0.18 to 0.07). Sufficient information was provided on dose, setting, and provider; but not content and procedural information. Studies tended to report the type of CB component used (e.g., challenging unhelpful thoughts) with little detail on how it was operationalised. Moreover, access to treatment manuals, patient materials and provider training was lacking. Conclusions: With additional training, physiotherapists can deliver effective CB interventions. However, without training or resources, successful translation and implementation remains unlikely. Researchers should improve reporting of procedural information, provide relevant materials, and offer accessible provider training. Implications for Rehabilitation Previous reviews have established that traditional biomedical-based treatments (e.g., acupuncture, manual therapy, massage, and specific exercise programmes) that focus only on physical symptoms do provide short-term benefits but the sustained effect is questionable. A cognitive-behavioural (CB) approach includes techniques to target both physical and psychosocial symptoms related to pain and provides patients with long-lasting skills to manage these symptoms on their own. This combined method has been used in a variety of settings delivered by different health care professionals and has been shown to produce long-term effects on patient outcomes. What has been unclear is if these programmes are effective when delivered by physiotherapists in routine physiotherapy settings. Our study synthesises the evidence for this context. We have confirmed with high-quality evidence that with additional training, physiotherapists can deliver CB interventions that are effective for patients with back pain. Physiotherapists who are considering enhancing their treatment for patients with low back pain should consider undertaking some additional training in how to incorporate CB techniques into their practice to optimise treatment benefits and help patients receive long-lasting treatment effects. Importantly, our results indicate that using a CB approach, including a variety of CB techniques that could be easily adopted in a physical therapy setting, provides greater benefits for patient outcomes compared to brief education, exercise or physical techniques (such as manual therapy) alone. This provides further support that a combined treatment approach is likely better than one based on physical techniques alone. Notably, we identified a significant barrier to adopting any of these CB interventions in practice. This is because no study provided a description of the intervention or accessible training materials that would allow for accurate replication. Without access to provider training and/or resources, we cannot expect this evidence to be implemented in practice with optimal effects. Thus, we would urge physiotherapists to directly contact authors of the studies for more information on how to incorporate their interventions into their settings.

Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER)

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. Methods This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. Discussion The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Protocol version Version 2.1; dated 11 January 2017 Trial registration number ISRCTN35358984; Pre-results.

G371 Defining transient abnormal myelopoiesis (TAM) and silent tam in neonates with down syndrome

Background and aims Children with Down syndrome (DS) have a 150-fold-increased risk of acute myeloid leukaemia (ML-DS) in the first 5y of life (peak age 12–15 months). ML-DS is preceded by Transient Abnormal Myelopoiesis (TAM), a neonatal pre-leukaemic disorder unique to DS. Recent studies of clinically-diagnosed TAM show acquired mutations in the GATA1 gene in all cases. However, the true clinical spectrum of TAM is unknown since previous retrospective reports have not systematically evaluated blood films or GATA1 mutation status. The purpose of our study was to prospectively determine the clinical, haematological, molecular features and natural history of TAM. Methods Neonates with karyotypically-confirmed DS were prospectively enrolled to the Oxford-Imperial DS Cohort Study (OIDSCS) from October 2006. Detailed clinical and FBC/blood film data were matched to GATA1 mutational analysis by Sanger sequencing/Direct High Performance Liquid Chromatography (Ss/DHPLC). Targeted next-generation-sequencing (NGS) was used to determine clone size and/or detect small (<5%) mutant GATA1 clones. TAM was prospectively defined as: >10% peripheral blood blasts and GATA1 mutation(s) detected by Ss/DHPLC. Silent TAM was defined as: blasts <10% and GATA1 mutation (s) detected by Ss/DHPLC or NGS. Results Of 382 neonates recruited to OIDSCS by June 2014, 39 (10.2%) had TAM. Although no clinical features were specific for TAM, hepatosplenomegaly, pericardial/pleural effusion and skin rash were more common in TAM (p < 0.0001, p < 0.01, p < 0.05) than DS neonates without GATA1 mutations. The only haematological features specific for TAM were blasts >20% and WBC >45 × 109/L. Ten neonates with TAM and 8 without TAM had 11–20% blasts. In 163 DS neonates with blasts <10% screened by NGS, 33(20.2%) had small GATA1 clones (Silent TAM); their clinical and haematological features were indistinguishable from 130/163 without mutations. 4 neonates with TAM received low-dose chemotherapy and 1 died. ML-DS has developed in 4/39 TAM, 1/33 Silent TAM and no DS neonates without GATA1 mutations (median follow-up 57 months, range 18- >60). Conclusion In neonates with DS, acquired mutations in the GATA1 gene are common, often clinically and haematologically silent and confer a risk of ML-DS in TAM and Silent TAM.

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER)

BackgroundMusculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER).MethodsA pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres.DiscussionThe PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN 35358984.

A systematic review and meta-analysis of online versus alternative methods for training licensed health care professionals to deliver clinical interventions

BackgroundOnline training is growing in popularity and yet its effectiveness for training licensed health professionals (HCPs) in clinical interventions is not clear. We aimed to systematically review the literature on the effectiveness of online versus alternative training methods in clinical interventions for licensed Health Care Professionals (HCPs) on outcomes of knowledge acquisition, practical skills, clinical behaviour, self-efficacy and satisfaction.MethodsSeven databases were searched for randomised controlled trials (RCTs) from January 2000 to June 2015. Two independent reviewers rated trial quality and extracted trial data. Comparative effects were summarised as standardised mean differences (SMD) and 95% confidence intervals. Pooled effect sizes were calculated using a random-effects model for three contrasts of online versus (i) interactive workshops (ii) taught lectures and (iii) written/electronic manuals.ResultsWe included 14 studies with a total of 1089 participants. Most trials studied medical professionals, used a workshop or lecture comparison, were of high risk of bias and had small sample sizes (range 21-183). Using the GRADE approach, we found low quality evidence that there was no difference between online training and an interactive workshop for clinical behaviour SMD 0.12 (95% CI -0.13 to 0.37). We found very low quality evidence of no difference between online methods and both a workshop and lecture for knowledge (workshop: SMD 0.04 (95% CI -0.28 to 0.36); lecture: SMD 0.22 (95% CI: -0.08, 0.51)). Lastly, compared to a manual (n = 3/14), we found very low quality evidence that online methods were superior for knowledge SMD 0.99 (95% CI 0.02 to 1.96). There were too few studies to draw any conclusions on the effects of online training for practical skills, self-efficacy, and satisfaction across all contrasts.ConclusionsIt is likely that online methods may be as effective as alternative methods for training HCPs in clinical interventions for the outcomes of knowledge and clinical behaviour. However, the low quality of the evidence precludes drawing firm conclusions on the relative effectiveness of these training methods. Moreover, the confidence intervals around our effect sizes were large and could encompass important differences in effectiveness. More robust, adequately powered RCTs are needed.