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"Reckless, Ian"
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Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial
2015
Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding.
In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532.
Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in the restrictive policy vs 83% (25) in the liberal policy (difference 14%; 95% CI 7–21; p=0·005). Mean last recorded haemoglobin concentration was 116 (SD 24) g/L for patients on the restrictive policy and 118 (20) g/L for those on the liberal policy (difference −2·0 [95% CI −12·0 to 7·0]; p=0·50). Fewer patients received RBCs on the restrictive policy than on the liberal policy (restrictive policy 133 [33%] vs liberal policy 247 [46%]; difference −12% [95% CI −35 to 11]; p=0·23), with fewer RBC units transfused (mean 1·2 [SD 2·1] vs 1·9 [2·8]; difference −0·7 [–1·6 to 0·3]; p=0·12), although these differences were not significant. We noted no significant difference in clinical outcomes.
A cluster randomised design led to rapid recruitment, high protocol adherence, separation in degree of anaemia between groups, and non-significant reduction in RBC transfusion in the restrictive policy. A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding.
NHS Blood and Transplant Research and Development.
Journal Article
Effectiveness of a digital health and financial incentive intervention to promote physical activity in patients with type 2 diabetes: study protocol for a randomised controlled trial with a nested qualitative study—ACTIVATE trial
by
Sanders, James P.
,
Colda, Antoanela
,
Turner, Joanne
in
Biomedicine
,
Blood pressure
,
Cost analysis
2024
Background
The prevention of type 2 diabetes (T2DM) is recognised as a health care priority in the UK. In people living with T2DM, lifestyle changes (e.g. increasing physical activity) have been shown to slow disease progression and protect from the development of associated comorbidities. The use of digital health technologies provides a strategy to increase physical activity in patients with chronic disease. Furthermore, behaviour economics suggests that financial incentives may be a useful strategy for increasing the maintenance and effectiveness of behaviour change intervention, including physical activity intervention using digital health technologies. The Milton Keynes Activity Rewards Programme (MKARP) is a 24-month intervention which combines the use of a mobile health app, smartwatch (Fitbit or Apple watch) and financial incentives to encourage people living with T2DM to increase physical activity to improve health. Therefore, this randomised controlled trial aims to examine the long-term acceptability, health effects and cost-effectiveness of the MKARP on HbA1c in patients living with T2DM versus a waitlist usual care comparator.
Methods
A two-arm, single-centre, randomised controlled trial aiming to recruit 1018 participants with follow-up at 12 and 24 months. The primary outcome is the change in HbA1c at 12 months. Secondary outcomes included changes in markers of metabolic, cardiovascular, anthropometric, and psychological health along with cost-effectiveness. Recruitment will be via annual diabetes review in general practices, retinal screening services and social media. Participants aged 18 or over, with a diagnosis of type 2 diabetes and a valid HbA1c measurement in the last 2 months are invited to take part in the trial. Participants will be individually randomised (1:1 ratio) to receive either the Milton Keynes Activity Rewards Programme or usual care. The intervention will last for 24 months with assessment for outcomes at baseline, 12 and 24 months.
Discussion
This study will provide new evidence of the long-term effectiveness of an activity rewards scheme focused on increasing physical activity conducted within routine care in patients living with type 2 diabetes in Milton Keynes, UK. It will also investigate the cost-effectiveness of the intervention.
Trial registration
ISRCTN 14925701. Registered on 30 October 2023.
Journal Article
Public health perspective on new weight loss medications
2024
New drugs are not the answer to obesity
Journal Article
Secondary spontaneous pneumothorax: a rare complication of pulmonary embolism
by
Ferrett, Colin
,
Mathieson, Philip
,
Reckless, Ian
in
80 years
,
Aged, 80 and over
,
Anticoagulants
2012
An 85-year-old lady presented with a left middle cerebral artery territory infarct. Several days into her admission she became hypoxic and haemodynamically unstable. A CT pulmonary angiogram showed bilateral pulmonary emboli, right-sided parenchymal cavitation due to infarction and an associated large pneumothorax. She was treated successfully with an intercostal drain and anticoagulation. This case describes the rare phenomenon of secondary spontaneous pneumothorax due to pulmonary infarction from pulmonary embolism. The factors associated with the development of infarcts from pulmonary thromboemboli are poorly understood although a number of predisposing conditions and pathological features have been suggested. Pulmonary infarction occurs in around 10% of cases of pulmonary emboli but the complication of secondary spontaneous pneumothorax would appear to be much less common. One should consider pulmonary embolism as the cause of pneumothorax where there is significant clinical suspicion.
Journal Article
Ten minutes with Dr Ian Reckless, Medical Director, Milton Keynes University Hospital NHS Foundation Trust
by
Reckless, Ian
,
Berendt, Anthony
in
10 minutes with
,
Appointments & personnel changes
,
clinical leadership
2020
Correspondence to Dr Anthony Berendt, Oxford, UK; a.berendt@ntlworld.com Biography Ian Reckless is Medical Director at Milton Keynes University Hospital NHS Foundation Trust, and Consultant in Stroke and General Medicine in Milton Keynes and at Oxford University Hospitals NHS Foundation Trust. Tell us a little bit about your leadership role and how it is changing as a result of the pandemic? I am Medical Director of a single site acute hospital. [...]staff are having to knuckle down to a period of intense working, and they are being forced to question fundamentals; working well outside their comfort zones and with staff ratios that would shock in normal times.
Journal Article
Avoiding Errors in Adult Medicine
by
Reckless, Ian
,
Bonser, Jonathan
,
Reynolds, D. John
in
State Medicine - legislation & jurisprudence - Great Britain
2013,2012
Some of the most important and best lessons in a doctor's career are learnt from mistakes. However, an awareness of the common causes of medical errors and developing positive behaviours can reduce the risk of mistakes and litigation. Written for junior medical staff and consultants, and unlike any other clinical management title available, Avoiding Errors in Adult Medicine identifies and explains the most common errors likely to occur in an adult medicine setting - so that you won't make them. The first section in this brand new guide discusses the causes of errors in adult medicine. The second and largest section consists of case scenarios and includes expert and legal comment as well as clinical teaching points and strategies to help you engage in safer practice throughout your career. The final section discusses how to deal with complaints and the subsequent potential medico-legal consequences, helping to reduce your anxiety when dealing with the consequences of an error. Invaluable during the Foundation Years, Specialty Training and for Consultants, Avoiding Errors in Adult Medicine is the perfect guide to help tackle the professional and emotional challenges of life as a physician.
Accuracy of UK Rapid Test Consortium (UK-RTC) “AbC-19 Rapid Test” for detection of previous SARS-CoV-2 infection in key workers: test accuracy study
2020
AbstractObjectiveTo assess the accuracy of the AbC-19 Rapid Test lateral flow immunoassay for the detection of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.DesignTest accuracy study.SettingLaboratory based evaluation.Participants2847 key workers (healthcare staff, fire and rescue officers, and police officers) in England in June 2020 (268 with a previous polymerase chain reaction (PCR) positive result (median 63 days previously), 2579 with unknown previous infection status); and 1995 pre-pandemic blood donors.Main outcome measuresAbC-19 sensitivity and specificity, estimated using known negative (pre-pandemic) and known positive (PCR confirmed) samples as reference standards and secondly using the Roche Elecsys anti-nucleoprotein assay, a highly sensitive laboratory immunoassay, as a reference standard in samples from key workers.ResultsTest result bands were often weak, with positive/negative discordance by three trained laboratory staff for 3.9% of devices. Using consensus readings, for known positive and negative samples sensitivity was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was 97.9% (97.2% to 98.4%). Using an immunoassay reference standard, sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but 84.7% (80.6% to 88.1%) among other people with antibodies. This is consistent with AbC-19 being more sensitive when antibody concentrations are higher, as people with PCR confirmation tended to have more severe disease whereas only 62% (218/354) of seropositive participants had had symptoms. If 1 million key workers were tested with AbC-19 and 10% had actually been previously infected, 84 700 true positive and 18 900 false positive results would be projected. The probability that a positive result was correct would be 81.7% (76.8% to 85.8%).ConclusionsAbC-19 sensitivity was lower among unselected populations than among PCR confirmed cases of SARS-CoV-2, highlighting the scope for overestimation of assay performance in studies involving only PCR confirmed cases, owing to “spectrum bias.” Assuming that 10% of the tested population have had SARS-CoV-2 infection, around one in five key workers testing positive with AbC-19 would be false positives.Study registrationISRCTN 56609224.
Journal Article
Secondary spontaneous pneumothorax: a rare complication of pulmonary embolism
2012
An 85-year-old lady presented with a left middle cerebral artery territory infarct. Several days into her admission she became hypoxic and haemodynamically unstable. A CT pulmonary angiogram showed bilateral pulmonary emboli, right-sided parenchymal cavitation due to infarction and an associated large pneumothorax. She was treated successfully with an intercostal drain and anticoagulation. This case describes the rare phenomenon of secondary spontaneous pneumothorax due to pulmonary infarction from pulmonary embolism. The factors associated with the development of infarcts from pulmonary thromboemboli are poorly understood although a number of predisposing conditions and pathological features have been suggested. Pulmonary infarction occurs in around 10% of cases of pulmonary emboli but the complication of secondary spontaneous pneumothorax would appear to be much less common. One should consider pulmonary embolism as the cause of pneumothorax where there is significant clinical suspicion.
Report