Neil Edward O'Connell

Brunel University London · Health Economics Research Group

Background The aim of the INSPECT-SR project is to develop a tool to identify problematic RCTs in systematic reviews. In Stage 1 of the project, a list of potential trustworthiness checks was created. The checks on this list must be evaluated to determine which should be included in the INSPECT-SR tool. Methods We attempted to apply 72 trustworthin...

The ENTRUST-PE project convened an international network of experts to develop an integrated framework for enhancing and ensuring the trustworthiness of pain research. This summary introduces and explains the framework for patients and the public.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This executive summary outlines the key features of that framework.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Editors and Publishers.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Institutions that undertake research.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Researchers.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Regulators and Policymakers.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Funders of Research.

The ENTRUST-PE project convened an international, interdisciplinary network to develop an integrated framework for enhancing and facilitating the trustworthiness of pain research. This summary outlines the key features of that framework and presents recommendations for Peer Reviewers of research.

The personal, social and economic burden of chronic pain is enormous. Yet patients with chronic pain, clinicians and the public are often poorly served by an evidence architecture that contains multiple structural weaknesses which reduce confidence in treatment practice. Weaknesses include incomplete research governance, a lack of diversity and inc...

Background Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are l...

Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological feat...

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 in...

Introduction Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological fea...

Background: Chronic pain is a major health and socioeconomic burden, which is prevalent in children and adolescents. Among the most widely used interventions in children and adolescents are physical activity (including exercises) and education about physical activity. Objectives: To evaluate the effectiveness of physical activity, education abou...

We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive behavioural therapy (CBT) and exercise in spinal pain. We identified multiple concerns in eight trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials ("index trials") on results, conclusions and...

Background: Complex regional pain syndrome (CRPS) is a chronic pain condition that usually occurs in a limb following trauma or surgery. It is characterised by persisting pain that is disproportionate in magnitude or duration to the typical course of pain after similar injury. There is currently no consensus regarding the optimal management of CRP...

Retraction is a mechanism for correcting the scientific record and alerts readers when a study contains unreliable or flawed data. Such data may arise from error or research misconduct. Studies examining the landscape of retracted publications provide insight into the extent of unreliable data and its effect on a medical discipline. We aimed to exp...

Background: Pharmacological interventions are the most used treatment for low back pain (LBP). Use of evidence from systematic reviews of the effects of pharmacological interventions for LBP published in the Cochrane Library, is limited by lack of a comprehensive overview. Objectives: To summarise the evidence from Cochrane Reviews of the effica...

Objective To evaluate the comparative effectiveness and safety of analgesic medicines for acute non-specific low back pain. Design Systematic review and network meta-analysis. Data sources Medline, PubMed, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and World Health Organization’s International Clinical Trials Registr...

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...

Trustworthiness in clinical trials for persistent pain with unexplained outlying results

Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear. Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain. Design, setting, and par...

Aims To systematically review randomised control trials (RCT’s) assessing the effectiveness and safety of surgical interventions in adults with plantar fasciopathy (PF). Materials and methods We searched MEDLINE, EMBASE, Web of Science, Google Scholar, the Cochrane Central Register of Controlled Trials, trial registries and references lists. RCT’s...

Background: Complex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is a...

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 au...

Background: Implanted spinal neuromodulation (SNMD) techniques are used in the treatment of refractory chronic pain. They involve the implantation of electrodes around the spinal cord (spinal cord stimulation (SCS)) or dorsal root ganglion (dorsal root ganglion stimulation (DRGS)), and a pulse generator unit under the skin. Electrical stimulation...

We aimed to evaluate the evidence reported to underpin exercise dose in randomised controlled trials (RCTs) using strengthening exercise in RA. We searched six different databases between 1 January 2000 and 3 April 2019. We included RCTs, where a main component of the intervention and/or control used strengthening exercise. Evidence sources cited t...

Background Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded s...

Aim To compare the rate of falls between adults with and without cerebral palsy (CP). Method We used primary care data on 1705 adults with CP and 5115 adults without CP matched for age, sex, and general practice attended. We compared odds of experiencing a fall between adults with and without CP using conditional logistic regression. We compared t...

Introduction Plantar fasciopathy (PF) is a degenerative condition of the plantar fascia, secondary to repetitive overloading. For the majority, PF is self-limiting with greater than 80% of those affected gaining complete resolution within 1 year. However, persistent symptoms develop in approximately 10% of cases. Clinical practice guidelines for fi...

Objective: To compare the incidence of noncommunicable diseases between adults with and without cerebral palsy (CP). Methods: A cohort study was conducted using primary care data from the Clinical Practice Research Datalink. Cox models, stratified by matched set and adjusted for potential confounders, were fitted to compare the risk of any nonco...

Background: People with cerebral palsy (CP) may be at increased risk of musculoskeletal conditions due to various factors including malnutrition and abnormal levels of skeletal loading. This study aimed to compare the incidence of osteoporosis, osteoarthritis and inflammatory musculoskeletal diseases between adults with and without CP. Methods:...

Background: Chronic pain, considered to be pain lasting more than three months, is a common and often difficult to treat condition that can significantly impact upon function and quality of life. Treatment typically includes pharmacological and non-pharmacological approaches. Transcutaneous electrical nerve stimulation (TENS) is an adjunct non-pha...

Background: Chronic pain, considered to be pain lasting more than three months, is a common and often difficult to treat condition that can significantly impact upon function and quality of life. Treatment typically includes pharmacological and non-pharmacological approaches. Transcutaneous electrical nerve stimulation (TENS) is an adjunct non-pha...

Aim To compare mortality rates for cardiovascular disease, cancer, and respiratory disease between adults with cerebral palsy (CP) and the general population. Method A cohort study was conducted using data from adults with CP in England, identified through a primary care data set (the Clinical Practice Research Datalink), with linked data on death...

Importance Cerebral palsy (CP) is considered a pediatric condition despite most individuals with CP living into adulthood. Thus, there is a lack of evidence in adults with CP, which includes a paucity of research examining mental health in this population. Objectives To determine the risk of depression and anxiety in adults with CP compared with a...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To answer the clinical question: 'what analgesic medicine shall I prescribe this patient with chronic low back pain to reduce their pain?'. The objectives are to determine the analgesic effects, safety, effect on function, and relative rank according to analgesi...

Background: This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic...

Background: This is an updated version of the original Cochrane Review published in 2010, Issue 9, and last updated in 2014, Issue 4. Non-invasive brain stimulation techniques aim to induce an electrical stimulation of the brain in an attempt to reduce chronic pain by directly altering brain activity. They include repetitive transcranial magnetic...

The burden that low back pain (LBP) presents to sufferers and society is well established. This ubiquitous condition is served by a complex global clinical marketplace offering a wide range of assessment alternatives and accompanying interventions. Yet, while the costs of care are rising, the global burden does not appear to be diminishing. Conside...

As a potential high-yield tool for disseminating information that can reach many people, social media is transforming how clinicians, the public, and policy makers are educated and find new knowledge associated with research-related information. Social media is available to all who access the internet, reducing selected barriers to acquiring origin...

Introduction: International clinical guidelines for Complex Regional Pain Syndrome recommend a wide range and variation of rehabilitation therapies as the core treatment. It is likely that most therapists employ a range of approaches when managing people with Complex Regional Pain Syndrome but a recent Cochrane review identified little evidence rel...

Chronic pain can be associated with movement abnormalities. The primary motor cortex (M1) has an essential role in the formulation and execution of movement. A number of changes in M1 function have been reported in studies of people with chronic pain. This review systematically evaluated the evidence for altered M1 structure, organization, and func...

Background/aim Resistance training is beneficial for rehabilitation in many clinical conditions, though this has not been systematically reviewed in burns. The objective was to determine the effectiveness of resistance training on muscle strength, lean mass, function, quality of life and pain, in children and adults after burn injury. Methods Me...

Background: Neuropathic pain, which is due to nerve disease or damage, represents a significant burden on people and society. It can be particularly unpleasant and achieving adequate symptom control can be difficult. Non-pharmacological methods of treatment are often employed by people with neuropathic pain and may include transcutaneous electrica...

The presence of bimodal outcome distributions has been used as a justification for conducting responder analyses, in addition to, or in place of analyses of the mean between-group difference, in clinical trials and systematic reviews of interventions for pain. The aim of this study was to investigate the distribution of participants' pain outcomes...

Background: Cerebral palsy (CP) is a neurodevelopmental disorder resulting from an injury to the developing brain. It is the most common form of childhood disability with prevalence rates of between 1.5 and 3.8 per 1000 births reported worldwide. The primary impairments associated with CP include reduced muscle strength and reduced cardiorespirato...

Given the scale and cost of the low back pain problem, it is imperative that healthcare professionals involved in the care of people with low back pain have access to up-to-date, evidence-based information to assist them in treatment decision-making. Clinical guidelines exist to promote the consistent best practice, to reduce unwarranted variation...

Navigating the maze of evidence relating to clinical effectiveness in chronic pain is a challenge. In order to do it successfully we need an understanding of the various sources of bias and error that can occur in clinical trials, the broader biases and imperfect practices in the clinical research ecosystem, and all the ways in which we personally...

Objective: The presence of bimodal outcome distributions has been used as a justification for conducting responder analyses, in addition to, or in place of analyses of mean difference, in clinical trials and systematic reviews of interventions for pain. The aim of this study was to investigate the distribution of participants' pain outcomes for ev...

Upregulation of defensive reflexes such as the nociceptive flexion reflex (NFR) has been attributed to sensitisation of peripheral and spinal nociceptors and is often considered biomarkers of pain. Experimental modulation of defensive reflexes raises the possibility that they might be better conceptualised as markers of descending cognitive control...

Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tes...

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Background: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews, 2005, Issue 4 (and last updated in the Cochrane Database of Systematic Reviews, 2013 issue 8), on local anaesthetic blockade (LASB) of the sympathetic chain to treat people with complex regional pain syndrome (CRPS). Objectives:...

Perspective: Several lines of evidence suggest that body perception might be disturbed in people with chronic low back pain, possibly contributing to the condition and offering a potential target for treatment. The Fremantle Back Awareness Questionnaire was developed as a quick and simple way of measuring back specific body-perception in people wi...

Background: Complex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery. When it occurs, it is associated with significant pain and disability. It is thought to arise and persist as a consequence of a maladaptive pro-inflammatory response and disturbances in sympathetically-med...

Introduction Primary motor cortical (M1) adaptation in the form of altered organisation and function is hypothesised to underpin motor dysfunction observed in chronic pain. The aim of this review is to assess the evidence for altered M1 organisation and function in chronic pain. Methods and analysis Systematic review and meta-analysis. We will sear...

NICE has developed a medtech innovation briefing (MIB) on the Active‑B12 assay for diagnosing vitamin B12 deficiency. The Abbott ARCHITECT Active‑B12 assay is a test for detecting levels of serum holotranscobalamin, which is the metabolically available component of vitamin B12, and can be used as a marker of vitamin B12 deficiency. Four diagnostic...

NICE has developed a medtech innovation briefing (MIB) on the BD MAX Enteric Bacterial Panel for identifying pathogens in contagious gastroenteritis. The BD MAX Enteric Bacterial Panel (EBP) is an assay that detects common enteric bacterial pathogens (which can cause gastroenteritis) from stool samples in 2–3 hours; current standard culture method...

There is no shortage of treatment approaches offered to sufferers of pain. The maze of options presents patients and clinicians with difficult choices. Key to making those choices is evidence of treatment effectiveness provided by clinical trials and systematic reviews. Recent growth in the number of clinical trials and systematic reviews, of both...

Not recommended; early promise is fading fast as trial methods improve Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that delivers low intensity direct current stimulation to the brain through electrodes applied to the skin over the target area. It has been found to modulate cortical excitability at the...

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary aim of this systematic review is to evaluate the effect of exercise interventions on activity, participation, and health-related quality of life (HRQoL) in adults and children with CP. The secondary aim is to evaluate the effect of exercise intervent...

Complex regional pain syndrome (CRPS), perhaps more than any other chronic pain disorder, is perplexing. It is highly disabling, particularly once it has “set in,” and it has a tendency to polarize the community—some view it as a quasidiagnosis to obscure malingering or conceal substandard clinical skills,¹ and others as a multiple system overprote...