IRAS Project ID Research Articles

Is the Current Threshold for Diagnosis of 'Abnormality', Including Non ST Elevation Myocardial Infarction, Using Raised High Sensitivity Troponin Appropriate for a Hospital Population? The CHARIOT Study

Objective: To define the 99th percentile of high sensitivity cardiac troponin I (hs-cTnI) concentration for a hospital population. Design: Prospective study of 20,000 consecutive patients undergoing blood sampling for any reason at a large teaching hospital. Setting: University Hospital Southampton NHS Trust (UHS). Participants: 20,000 consecutive individuals, inpatient or outpatient, undergoing blood tests at UHS for any clinical reason. Hs-cTnI concentrations (Beckman Coulter Access AccuTnI 3 assay) were nested for analysis in all cases except those in whom the supervising physician had requested hs-cTnI for clinical reasons. Main outcome measures: Distribution of hs-cTnI concentrations of all study patients. Results: The 99th percentile of hs-cTnI for the whole population (n=20,000) was 296 ng/L, compared to a manufacturer quoted 99th percentile of 40 ng/L (currently used clinically as the upper limit of normal, ULN). In 1 in 20 (5.4%, n=1080) of the total population hs-cTnI concentrations were above 40 ng/L. After exclusion of individuals diagnosed with an acute myocardial infarction (AMI) (n=122), or those in whom troponin was requested (n=1707), the 99th percentile of the remainder (n=18,171) was 189 ng/L. The 99th percentile for inpatients (n=4759) and outpatients (n=9280) was 563 ng/L and 65 ng/L, respectively. Patients from the emergency department (n=3706) had a 99th percentile of 215 ng/L, with 6.1% (n=491) above the quoted ULN. 39% (n=48) of all individuals from the critical care units (n=123) and 15.7% (n=87) of all medical inpatients had a hs-cTnI concentration above the quoted ULN. Conclusions: In 20,000 consecutive patients undergoing a blood test for any reason at this hospital 1 in 20 have a hs-cTnI above the manufacturer quoted ULN. These data highlight the need for clinical staff to interpret hs-cTnI concentrations carefully, particularly when applying the manufacturer's ULN to diagnose AMI. The use of hs-cTn to diagnose AMI in any patient without a typical history may be flawed. Funding Statement: Unrestricted Research Grant – Beckman Coulter Declaration of Interests: M. Mariathas – none declared, R. Allan – none declared, B. Olechowski – none declared, S. Ramamoorthy – none declared, M. Azor – none declared, Z. Nicholas – none declared, A. Calver – none declared, S. Corbett – none declared, M. Mahmoudi – none declared, J. Rawlins – none declared, I. Simpson – none declared, J. Wilkinson – none declared, C. Kwok- none declared, M. Mamas- none declared, P. Cook – none declared, N. Curzen – unrestricted research grants from: Boston Scientific; Haemonetics; Heartflow; Beckmann Coulter. Speaker fees/consultancy from: Haemonetics, Abbot Vascular; Heartflow; Boston Scientific. Travel sponsorship – Biosensors, Abbot, Lilly/D-S; St Jude Medical, Medtronic. Ethics Approval Statement: This research project was undertaken according to the principles of Good Clinical Practice and the Declaration of Helsinki. The study was approved by the local ethical committee who then referred it to the Health Research Authority (HRA) UK for further approval (Rec reference: 17/SC/0042, IRAS project ID: 215262). The method did not require knowledge or consent from patients.

Treatment in the STAMPEDE era for castrate resistant prostate cancer in the UK: ongoing challenges and underappreciated clinical problems

BackgroundThis study aimed to explore the opinions of healthcare professionals regarding the management of men with advanced prostate cancer with particular emphasis on treatment timing and sequencing; treatment adverse-effects and exercise a supportive therapy.MethodsSemi-structured interviews with a purposively selected group of healthcare professionals involved in prostate cancer care within the NHS, conducted over the phone or face to face. A total of 37 healthcare professionals participated in the interviews including urologists, clinical oncologists, medical oncologists, clinical nurse specialists, general practitioners, physiotherapists, exercise specialists, service managers, clinical commissioners and primary care physicians.ResultsThe availability of newer treatments for advanced prostate cancer as well as results from the STAMPEDE and CHAARTED trials has resulted in new challenges for patients and HCPs. This includes the impact of an increased workload on oncologists, a potential lack of clinical continuity between urology and oncology and uncertainties regarding optimal selection, timing and sequencing of chemotherapy and second-line treatment. Fitness for treatment in advanced prostate cancer populations remains a significant barrier to accessing therapies for patients with a poor performance status. Among this, muscle wastage can significantly affect performance status and consequentially compromise cancer therapy. Exercise was regarded as a potential therapy to mitigate the adverse-effects of treatment including the prevention or reduction in muscle wastage.ConclusionsThere is a lack of data guiding clinicians in this post STAMPEDE and CHAARTED era, work is needed to reassess and optimize the prostate cancer care pathway as it evolves. Exercise should be explored as a therapeutic option to mitigate the effects of long term ADT. Further study from a wider cohort of both prostate cancer care specialists and patients will aid in establishing a highly functioning pathway with optimal individualised care.Trial registrationSustained exercise TrAining for Men wIth prostate caNcer on Androgen deprivation: the STAMINA programme (RP-DG-1213-10,010). REC Reference: 15/SW/0260 IRAS Project ID: 178340 Hospital ID: STH 18391 approved on 24/08/2015.

Influences of clinical experience in the quantification of morphometric sarcopaenia: a cohort study.

Influences of clinical experience in the quantification of morphometric sarcopaenia: a cohort study.

Willingness to Adhere to Current UK Low-Risk Alcohol Guidelines to Potentially Reduce Dementia Risk: A National Survey of People Aged 50 and Over

Background: People over 50 are increasing their alcohol intake, potentially increasing their risk of dementia. This study investigates whether people would be willing to adhere to current UK (low-risk) alcohol guidelines to reduce dementia risk. Methods: A national cross-sectional online survey recruited a non-probabilistic sample of 3,948 individuals aged 50 and over without dementia in the UK. Willingness to comply with low-risk guidelines was predicted using multivariate logistic regression. Relevant variables included physical health, lifestyle, and current alcohol intake. Outcomes: Majority of the sample (90%, n=3,527) reported drinking alcohol at least once a month with 23% (n=795) exceeding the low-risk guidelines (>14 units per week). A larger proportion of men, those who were overweight, and people without a partner reported drinking above the recommended level. Most people who consumed alcohol (n=2,934; 74·3%) appeared willing to adhere to low-risk guidelines if they were told that their risk of having dementia could be reduced. Increased willingness was found in women (OR 1·81; CI 1·47-2·23), in people who had at least one child (OR 1·36; CI 1·09-1·70) and those who slept well (OR 1·45; CI 1·06-2·00). People who were obese (OR 0·72; CI 0·54-0·95), those who drank alcohol above limits (OR 0·13; CI 0·11-0·16), and were smokers (OR 0·56; CI 0·36- 0·88) were less willing to adhere to current guidelines. Interpretation: Men and people with more lifestyle risk factors for common chronic diseases (e.g., smoking, obesity and excess alcohol consumption) are less willing to adhere to current alcohol low-risk guidelines to reduce dementia risk. Funding Statement: Alzheimer's Research UK. Declaration of Interests: DO has received funding from the Alzheimer’s Research UK. MO has received grants from the ESRC, NIHR and EU Commission for dementia care research. All the other authors have no conflict of interest. Ethics Approval Statement: The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Written informed consent was obtained from all participants. All procedures involving human subjects/patients were approved by the East Midlands - Nottingham Research Ethics Committee (IRAS project ID 177280; REC reference 16/EM/0044).

Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT)

IntroductionHigh rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been...

Oxidative stress response in patients with severe aortic stenosis undergoing transcatheter or surgical aortic valve replacement: protocol for a prospective observational study

Background: Myocardial ischemia and reperfusion injury mediated by reactive oxygen species (ROS) related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. The generation of ROS and its clinical impact in patients undergoing transcatheter aortic valve replacement (TAVR) have not been studied. Methods/Design: This is a prospective observational study that will compare the generation of ROS between 12 consecutive patients undergoing TAVR and 12 patients undergoing isolated surgical aortic valve replacement (SAVR) and will determine whether any potential differences are related to the 3-month composite endpoints of cardiovascular mortality, myocardial infarction, stroke, major bleeding or life threatening bleeding. Peripheral blood will be taken immediately before aortic intervention, at the completion of the procedure, 6-8 hours after the procedure, and 24 hours after the procedure for measurements of ROS. Clinical follow-up at 3 months post discharge will be undertaken either in the outpatient clinic or by telephone. Discussion: This study will determine changes in the levels of ROS in patients undergoing TAVR and identify whether any potential changes are correlated with clinical outcomes. Trial registration: ClinicalTrials.gov identifier: NCT02841917; registered on December 29, 2015. Ethics: The study protocol has been approved by the RES Committee North West Liverpool East (IRAS Project ID: 206946). Informed consent: Signed informed consent will be obtained from each patient who wishes to participate in this study.

Platinum segments: a new platinum chain for adjustable upper eyelid loading

PurposeProspective study evaluating outcomes of individually sutured platinum segment chains in upper eyelid loading.MethodsSingle-centre, single-surgeon, prospective study. Upper eyelid loading with 0.4 and 0.2 g platinum segment chains for lagophthalmos....

CRIB—the use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial (RCT) with embedded feasibility study

IntroductionPatients with colorectal cancer report ongoing physical and psychological impairments and a high proportion of these patients are overweight, insufficiently active and high-risk drinkers, putting them at risk of poor...