Chris Metcalfe
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View article: Development and application of quality assurance methods for interventions in randomised controlled trials of surgical oncology: the ROMIO study (a comparison of minimally invasive and open oesophagectomy)
Development and application of quality assurance methods for interventions in randomised controlled trials of surgical oncology: the ROMIO study (a comparison of minimally invasive and open oesophagectomy) Open
Introduction Results of RCTs are criticised because the quality assurance (QA) of surgical interventions is not considered. This is particularly true in cancer trials, because higher standards of surgery may confer more favourable outcomes…
View article: Trends of poisoning types in Sri Lanka: descriptive analysis of hospital admissions data 2004–2019
Trends of poisoning types in Sri Lanka: descriptive analysis of hospital admissions data 2004–2019 Open
Background Sri Lanka introduced national bans restricting access to highly hazardous pesticides (HHPs) in 2008-11, and in 2013-16. An immediate drop in pesticide poisoning cases was observed after the introduction of the first ban, but the…
View article: Patient‐reported outcome measures in prostate research: a scoping review
Patient‐reported outcome measures in prostate research: a scoping review Open
Objectives To summarise how patient‐reported outcome measures (PROMs) are used in prostate research, specifically in the 10 years after the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) guidelines were introduced. Methods The s…
View article: First Dental Steps intervention: feasibility study of a health visitor led infant oral health improvement programme
First Dental Steps intervention: feasibility study of a health visitor led infant oral health improvement programme Open
View article: intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi‐centre, acceptability and feasibility trial with nested qualitative methods
intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi‐centre, acceptability and feasibility trial with nested qualitative methods Open
Background and aim There is evidence that smoking cessation may improve depression and anxiety symptoms. We assessed the feasibility of implementing and trialling a smoking cessation intervention in services providing cognitive behavioural…
View article: A school-based intervention to improve mental health outcomes for children with cerebral visual impairment (CVI): feasibility cluster randomised trial
A school-based intervention to improve mental health outcomes for children with cerebral visual impairment (CVI): feasibility cluster randomised trial Open
Background Cerebral visual impairment (CVI) refers to brain-related vision difficulties, which are often undiagnosed and may lead to poor mental health outcomes. We have developed an intervention to improve mental health outcomes for affec…
View article: Preventing suicide by restricting access to Highly Hazardous Pesticides (HHPs): A systematic review of international evidence since 2017
Preventing suicide by restricting access to Highly Hazardous Pesticides (HHPs): A systematic review of international evidence since 2017 Open
Suicide is a leading cause of death worldwide. A previous systematic review showed that regulations limiting access to highly hazardous pesticides (HHPs) were successful in preventing suicides. As the WHO strongly supports regulation of pe…
View article: O01 Rapid respiratory microbiological POCTs and antibiotic use in primary care: the RAPID-TEST RCT
O01 Rapid respiratory microbiological POCTs and antibiotic use in primary care: the RAPID-TEST RCT Open
Background Antibiotics are prescribed for over 50% of RTIs in primary care, despite good evidence most patients do not benefit. Rapid multiplex microbiological point-of-care-tests (POCTRM) determine the presence/ absence of respiratory pat…
View article: The Effectiveness of Rivastigmine for Fall Prevention in People with Parkinson's Disease: A Double Blind, Placebo Controlled Multicentre Randomised Trial
The Effectiveness of Rivastigmine for Fall Prevention in People with Parkinson's Disease: A Double Blind, Placebo Controlled Multicentre Randomised Trial Open
View article: Effectiveness of an Environmental Nutrition and Physical Activity Intervention in Early Childhood Education and Care Settings: A Multicentre Cluster Randomised Controlled Trial (NAPSACC UK)
Effectiveness of an Environmental Nutrition and Physical Activity Intervention in Early Childhood Education and Care Settings: A Multicentre Cluster Randomised Controlled Trial (NAPSACC UK) Open
View article: Effectiveness and cost-effectiveness of guided self-help for depression for autistic adults: the Autism Depression Trial (ADEPT-2) – protocol for a multicentre, randomised controlled trial of a remotely delivered low-intensity intervention
Effectiveness and cost-effectiveness of guided self-help for depression for autistic adults: the Autism Depression Trial (ADEPT-2) – protocol for a multicentre, randomised controlled trial of a remotely delivered low-intensity intervention Open
Introduction Depression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression specifically adapted to meet t…
View article: Comparison of cognitive behaviour therapy versus activity management, both delivered remotely, to treat paediatric chronic fatigue syndrome/myalgic encephalomyelitis: the UK FITNET-NHS RCT
Comparison of cognitive behaviour therapy versus activity management, both delivered remotely, to treat paediatric chronic fatigue syndrome/myalgic encephalomyelitis: the UK FITNET-NHS RCT Open
Design Parallel-group randomised controlled trial. Methods Participants Adolescents aged 11–17 years, diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome and with no local specialist treatment centre, were referred to a speci…
View article: A pragmatic cluster randomised controlled trial of air filtration to prevent symptomatic winter respiratory infections (including COVID-19) in care homes (AFRI-c) in England: Trial protocol
A pragmatic cluster randomised controlled trial of air filtration to prevent symptomatic winter respiratory infections (including COVID-19) in care homes (AFRI-c) in England: Trial protocol Open
Background Respiratory tract infections are readily transmitted in care homes. Airborne transmission of pathogens causing respiratory tract illness is largely unmitigated. Portable high-efficiency-particulate-air (HEPA) filtration units ca…
View article: Colonoscopy findings after increasing two‐stool faecal immunochemical test (FIT) cut‐off: Cross‐sectional analysis of the SCREESCO randomized trial
Colonoscopy findings after increasing two‐stool faecal immunochemical test (FIT) cut‐off: Cross‐sectional analysis of the SCREESCO randomized trial Open
Background We determined the impact of an increased two‐stool faecal immunochemical test (FIT) cut‐off on colonoscopy positivity and relative sensitivity and specificity in the randomized controlled screening trial screening of Swedish col…
View article: Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial
Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial Open
Introduction Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observatio…
View article: Rapid respiratory microbiological point-of-care-testing and antibiotic prescribing in primary care: Protocol for the RAPID-TEST randomised controlled trial
Rapid respiratory microbiological point-of-care-testing and antibiotic prescribing in primary care: Protocol for the RAPID-TEST randomised controlled trial Open
Background Antibiotics are prescribed for over 50% of respiratory tract infections in primary care, despite good evidence of there being no benefit to the patient, and evidence of over prescribing driving microbial resistance. The high tre…
View article: Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality
Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality Open
Importance The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-ter…
View article: Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial
Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial Open
View article: Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial
Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial Open
Objective This study investigated if hybrid oesophagectomy with minimally invasive gastric mobilization and thoracotomy enabled faster recovery than open surgery. Methods In eight UK centres, this pragmatic RCT recruited patients for oesop…
View article: HepFREEPak: protocol for a multi-centre, prospective observational study examining efficacy and impact of current therapies for the treatment of hepatitis C in Pakistan and reporting resistance to antiviral drugs: study protocol
HepFREEPak: protocol for a multi-centre, prospective observational study examining efficacy and impact of current therapies for the treatment of hepatitis C in Pakistan and reporting resistance to antiviral drugs: study protocol Open
Background Pakistan has one of the highest burdens of Hepatitis C virus (HCV) infection globally. To achieve the World Health Organization’s goals for HCV elimination, there is a need for substantial scale-up in testing, treatment, and a r…
View article: The role of endoscopist adenoma detection rate in in sex differences in colonoscopy findings: cross-sectional analysis of the SCREESCO randomized controlled trial
The role of endoscopist adenoma detection rate in in sex differences in colonoscopy findings: cross-sectional analysis of the SCREESCO randomized controlled trial Open
This study provides no evidence that endoscopist skill measured by ADR underlies the sex difference in adenoma detection at colonoscopy. This study has trial number NCT02078804 and is registered with ClinicalTrials.gov.
View article: OGC O01 Minimally invasive or open oesophagectomy for localised oesophageal cancer: long-term follow-up of the ROMIO pragmatic randomised controlled trial
OGC O01 Minimally invasive or open oesophagectomy for localised oesophageal cancer: long-term follow-up of the ROMIO pragmatic randomised controlled trial Open
Background Patients with localised oesophageal cancer are frequently offered neoadjuvant treatment and surgery, with the benefit of improved survival but an expected at least short term negative impact on quality of life (QoL). Minimally i…
View article: A large-scale, multi-centre, prospective observational study to treat hepatitis C in Pakistan and assess resistance to antiviral drugs (HepFREEPak): study protocol
A large-scale, multi-centre, prospective observational study to treat hepatitis C in Pakistan and assess resistance to antiviral drugs (HepFREEPak): study protocol Open
Background: Pakistan has one of the highest burdens of Hepatitis C virus (HCV) infection globally. To achieve the World Health Organization’s goals for HCV elimination, there is a need for substantial scale-up in testing, treatment, and a …
View article: Suicide Rates in High-Risk High-Harm Perpetrators of Domestic Abuse in England and Wales
Suicide Rates in High-Risk High-Harm Perpetrators of Domestic Abuse in England and Wales Open
Background A limited amount of research indicates a high prevalence of mental illness in perpetrators of domestic abuse (DA). Aims Estimate the suicide rate in high-risk high-harm perpetrators of DA. Method We utilized data collected as pa…
View article: Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial
Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial Open
Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settin…
View article: Investigating the factors associated with meaningful improvement on the SF-36-PFS and exploring the appropriateness of this measure for young people with ME/CFS accessing an NHS specialist service: a prospective cohort study
Investigating the factors associated with meaningful improvement on the SF-36-PFS and exploring the appropriateness of this measure for young people with ME/CFS accessing an NHS specialist service: a prospective cohort study Open
Objectives Paediatric myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is relatively common and disabling, but little is known about the factors associated with outcome. We aimed to describe the number and characteristics of you…
View article: Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis
Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis Open
Background The factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more challenging due to child developmental stages, involving additional participants, and proxy…
View article: Data from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer
Data from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer Open
Epidemiologic studies suggest that diet can alter prostate cancer risk. This study aimed to establish the feasibility and acceptability of dietary modification in men at increased risk of prostate cancer. Men were invited with a PSA level …
View article: Supplementary Figure 1 from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer
Supplementary Figure 1 from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer Open
Figure of changes in lycopene and green tea intake over 6 months
View article: Supplementary Figure 1 from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer
Supplementary Figure 1 from ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer Open
Figure of changes in lycopene and green tea intake over 6 months