Investigating the veracity of a sample of divergent published trial data in spinal pain

Evidence-based medicine is replete with studies assessing quality and bias, but few evaluating research integrity or trustworthiness. A recent Cochrane review of psychological interventions for chronic pain identified trials with a shared lead author with highly divergent results. We sought to systematically identify all similar trials from this author to explore their risk of bias, governance procedures, and trustworthiness. We searched OVID MEDLINE, EMBASE, CENTRAL, and PEDro from 2010 to December 22, 2021 for trials. We contacted the authors requesting details of trial registration, ethical approval, protocol, and access to the trial data for verification. We used the Cochrane risk-of-bias tool and the Cochrane Pregnancy and Childbirth group's Trustworthiness Screening Tool to guide systematic exploration of trustworthiness. Ten trials were included: 9 compared cognitive behavioural therapy and physical exercise to usual care, exercise alone, or physiotherapy and 1 compared 2 brief cognitive behavioural therapy programmes. Eight trials reported results divergent from the evidence base. Assessment of risk of bias and participant characteristics identified no substantial concerns. Responses from the lead author did not satisfactorily explain this divergence. Trustworthiness screening identified concerns about research governance, data plausibility at baseline, the results, and apparent data duplication. We discuss the findings within the context of methods for establishing the trustworthiness of research findings generally. Important concerns regarding the trustworthiness of these trials reduce our confidence in them. They should probably not be used to inform the results and conclusions of systematic reviews, in clinical training, policy documents, or any relevant instruction regarding adult chronic pain management

PROTOCOL: A mixed methods systematic review on the effects of arts interventions for at‐risk and offending children and young people on behavioural, psychosocial, cognitive and offending outcomes

This is the protocol for a Campbell systematic review. The proposed systematic review question is: What is the effectiveness of arts interventions for at‐risk and offending children and young people (8‐25 years)? There are three objectives: (1) To evaluate evidence on the effectiveness and impact of arts interventions on keeping children safe from involvement in violence and crime; (2) To synthesise evidence on factors impacting the implementation of arts interventions, and barriers and facilitators to participation and achievement of intended outcomes; (3) To develop a theory‐of‐change approach to ensure the development of an evidence‐led framework of the processes by which arts interventions might work in preventing offending behaviours

Rates and predictors of risk of stroke and its subtypes in diabetes: a prospective observational study

Background Small vessel disease is reported to be a more common cause of ischaemic stroke in people with diabetes than in others. However, population based studies have shown no difference between those with and those without diabetes in the subtypes of stroke. We determined the rates and predictors of risk of stroke and its subtypes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. Methods 9795 patients aged 50–75 years with type 2 diabetes were followed up for a median of 5 years. Annual rates were derived by the Kaplan–Meier method and independent predictors of risk by Cox proportional hazards regression analyses. Results The annual rate of stroke was 6.7 per 1000 person years; 82% were ischaemic and caused by small artery disease (36%), large artery disease (17%) and embolism from the heart (13%); 10% were haemorrhagic. Among the strongest baseline predictors of ischaemic or unknown stroke were age (60–65 years, HR 1.98; >65 years, HR 2.35) and a history of stroke or transient ischaemic attack (TIA) (HR 2.06). Other independent baseline predictors were male sex, smoking, history of hypertension, ischaemic heart disease, nephropathy, systolic blood pressure and blood low density lipoprotein (LDL) cholesterol, HbA1c and fibrinogen. A history of peripheral vascular disease, low high density lipoprotein, age and history of hypertension were associated with large artery ischaemic stroke. A history of diabetic retinopathy, LDL cholesterol, male sex, systolic blood pressure, smoking, diabetes duration and a history of stroke or TIA were associated with small artery ischaemic stroke. Conclusions Older people with a history of stroke were at highest risk of stroke, but the prognosis and prognostic factors of subtypes were heterogeneous. The results will help clinicians quantify the absolute risk of stroke and its subtypes for typical diabetes patients.FIELD trial sponsored by Laboratoires Fournier SA, Dijon, France (part of Abbott

The effects of graded motor imagery and its components on chronic pain: A systematic review and meta-analysis

This is the post-print version of the final paper published in The Journal of Pain. The published article is available from the link below. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. Copyright @ 2013 The American Pain Society.Graded motor imagery (GMI) is becoming increasingly used in the treatment of chronic pain conditions. The objective of this systematic review was to synthesize all evidence concerning the effects of GMI and its constituent components on chronic pain. Systematic searches were conducted in 10 electronic databases. All randomized controlled trials (RCTs) of GMI, left/right judgment training, motor imagery, and mirror therapy used as a treatment for chronic pain were included. Methodological quality was assessed using the Cochrane risk of bias tool. Six RCTs met our inclusion criteria, and the methodological quality was generally low. No effect was seen for left/right judgment training, and conflicting results were found for motor imagery used as stand-alone techniques, but positive effects were observed for both mirror therapy and GMI. A meta-analysis of GMI versus usual physiotherapy care favored GMI in reducing pain (2 studies, n = 63; effect size, 1.06 [95% confidence interval, .41, 1.71]; heterogeneity, I2 = 15%). Our results suggest that GMI and mirror therapy alone may be effective, although this conclusion is based on limited evidence. Further rigorous studies are needed to investigate the effects of GMI and its components on a wider chronic pain population.NHMR

A mixed methods systematic review on the effects of arts interventions for children and young people at‐risk of offending, or who have offended on behavioural, psychosocial, cognitive and offending outcomes: A systematic review

Background: Young people who enter the justice system experience complex health and social needs, and offending behaviour is increasingly recognised as a public health problem. Arts interventions can be used with the aim of preventing or reducing offending or reoffending. Objectives: 1. To evaluate evidence on the effectiveness and impact of arts interventions on keeping children and young people safe from involvement in violence and crime. 2. To explore factors impacting the implementation of arts interventions, and barriers and facilitators to participation and achievement of intended outcomes. 3. To develop a logic model of the processes by which arts interventions might work in preventing offending behaviours. Search Methods: We searched AMED, Academic Search Complete; APA PsycInfo; CINAHL Plus; ERIC; SocIndex; SportDiscus, Medline, CENTRAL, Web of Science, Scopus, PTSDPubs and Performing Arts Periodicals Database, Sage, the US National Criminal Justice Reference Service, the Global Policing and British Library EThOS databases, and the National Police Library from inception to January 2023 without language restrictions. Selection Criteria: We included randomised and non‐randomised controlled trials and quasi‐experimental study designs. We included qualitative studies conducted alongside intervention trials investigating experiences and perceptions of participants, and offering insight into the barriers and facilitators to delivering and receiving arts interventions. We included qualitative and mixed methods studies focused on delivery of arts interventions. We included studies from any global setting. We included studies with CYP (8–25 years) who were identified as at‐risk of offending behaviour (secondary populations) or already in the criminal justice system (tertiary populations). We included studies of interventions involving arts participation as an intervention on its own or alongside other interventions. Primary outcomes were: (i) offending behaviour and (ii) anti‐pro‐social behaviours. Secondary outcomes were: participation/attendance at arts interventions, educational attainment, school attendance and engagement and exclusions, workplace engagement, wellbeing, costs and associated economic outcomes and adverse events. Data Collection and Analysis: We included 43 studies (3 quantitative, 38 qualitative and 2 mixed methods). We used standard methodological procedures expected by The Campbell Collaboration. We used GRADE and GRADE CERQual to assess the certainty of and confidence in the evidence for quantitative and qualitative data respectively. Main Results: We found insufficient evidence from quantitative studies to support or refute the effectiveness of arts interventions for CYP at‐risk of or who have offended for any outcome. Qualitative evidence suggested that arts interventions may lead to positive emotions, the development of a sense of self, successful engagement in creative practices, and development of positive personal relationships. Arts interventions may need accessible and flexible delivery and are likely to be engaging if they have support from staff, family and community members, are delivered by professional artists, involve culturally relevant activity, a youth focus, regularity and a sustainable strategy. We found limited evidence that a lack of advocacy, low funding, insufficient wider support from key personnel in adjacent services could act as barriers to success. Methodological limitations resulted in a judgement of very low confidence in these findings. Authors' Conclusions: We found insufficient evidence from quantitative studies to support or refute the effectiveness of arts interventions for CYP at‐risk of offending or who have offended for any outcome. We report very low confidence about the evidence for understanding the processes influencing the successful design and delivery of arts interventions in this population of CYP and their impact on behavioural, psychosocial, cognitive and offending outcomes

Complex regional pain syndrome: advances in epidemiology, pathophysiology, diagnosis, and treatment.

Complex regional pain syndrome (CRPS) is a rare pain disorder that usually occurs in a limb after trauma. The features of this disorder include severe pain and sensory, autonomic, motor, and trophic abnormalities. Research from the past decade has offered new insights into CRPS epidemiology, pathophysiology, diagnosis, and treatment. Early identification of individuals at high risk of CRPS is improving, with several risk factors established and some others identified in prospective studies during the past 5 years. Better understanding of the pathophysiological mechanisms of CRPS has led to its classification as a chronic primary pain disorder, and subtypes of CRPS have been updated. Procedures for diagnosis have also been clarified. Although effective treatment of CRPS remains a challenge, evidence-based integrated management approaches provide new opportunities to improve patient care. Further advances in diagnosis and treatment of CRPS will require coordinated, international multicentre initiatives