Thomas Macdonald

Thomas Macdonald
University of Dundee · Medicines Monitoring Unit (MEMO), Medical Research institute

BSC, MBCHB, MD

About

297
Publications
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Publications

Publications (297)
Article
Full-text available
Objectives To describe the incidence of adverse events (AEs), reactogenicity symptoms, menstrual changes and overall self-rated improvement in health and well-being after COVID-19 vaccination. Design VAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease...
Article
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Background Obtaining evidence on comparative effectiveness and safety of widely prescribed drugs in a timely and cost-effective way is a major challenge for healthcare systems. Here, we describe the feasibility of the Evaluating Diuretics in Normal Care (EVIDENCE) study that compares a thiazide and thiazide-like diuretics for hypertension as an exe...
Article
Full-text available
Home blood pressure monitor (HBPM) ownership prevalence and the factors that influence it are unclear. This study aimed to investigate factors associated with HBPM ownership among participants in the Treatment in Morning versus Evening (TIME) hypertension study. This study is a sub-analysis of the TIME study, a randomised trial investigating the ef...
Article
Full-text available
Various home blood pressure monitors (HBPMs) are available to the public for purchase but only some are validated against standardised protocols. This study aimed to assess whether HBPMs owned by participants taking part in a clinical trial were validated models. The TIME study is a decentralised randomised trial investigating the effect of antihyp...
Article
Aims: To evaluate, using quantitative and qualitative approaches, published data on the design and conduct of decentralised clinical trials (DCTs). Methods: We searched MEDLINE, EMBASE, CENTRAL, PsycINFO, ProQuest Dissertations and Theses, ClinicalTrials.gov, OpenGrey, and Google Scholar for publications reporting, discussing, or evaluating dece...
Article
Full-text available
Introduction Healthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For com...
Preprint
Full-text available
Background Obtaining evidence on comparative effectiveness and safety of widely prescribed drugs in a timely and cost-effective way is a major challenge for healthcare systems. Here we describe the feasibility of the Evaluating Diuretics in Normal Care (EVIDENCE) study that compares a thiazide and thiazide-like diuretics for hypertension as an exem...
Article
Full-text available
This study investigates factors associated with active participation, and long-term commitment, to home blood pressure monitoring (HBPM) in the TIME study, a remote clinical trial assessing the effectiveness of morning vs. evening dosing of antihypertensive medications on cardiovascular outcomes in adults with hypertension. Participants reporting H...
Article
Aims: We profile the lack of specific regulation for direct-to-patient postal supply (DTP) of clinical trial medications (Investigational Medicinal Products, IMPs) calling for increased efficiency of patient-centred multi-country remote clinical trials. Methods: Questionnaires emailed to 28 European Economic Area (EEA) Medical Product Licensing...
Article
Aims: The aim of the study was to identify actionable learning points from stakeholders in remote decentralised clinical trials (RDCTs) to inform their future design and conduct. Methods: Semistructured interviews were carried out with a purposive sample of stakeholders, including senior managers, trial managers, technology experts, principal in...
Article
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Abstract Objective Effervescent, soluble, dispersible formulations contain considerable amounts of sodium. In 2013, we previously confirmed the association between sodium-containing medications and cardiovascular risks. This study aimed to determine the changes in the prescribing pattern in clinical practice following this publication. Design A lo...
Article
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Background To manage the risk factors and to improve clinical outcomes, patients with stroke commonly receive multiple cardiovascular medications. However, there is a lack of evidence on the optimum combination of medication therapy in the primary care setting after ischemic stroke. Therefore, this study aimed to investigate the effect of multiple...
Article
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Background Hydroxyzine is indicated for the management of anxiety, skin and sleep disorders. In 2015, the European Medicines Agency (EMA) concluded that hydroxyzine was pro‐arrhythmogenic and changes to the product information were implemented in Europe. This study aimed to evaluate their impact in Denmark, Scotland, England and the Netherlands. M...
Preprint
Full-text available
Introduction Healthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For com...
Article
Background Febuxostat and allopurinol are urate-lowering therapies used to treat patients with gout. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency recommended a post-licensing study assessing the cardiovascular safety of febuxostat compared with allopurinol. Methods We did a prospective, randomised...
Article
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Objective: Due to cardiovascular safety concerns, the European Medicines Agency (EMA) recommended new contraindications and changes to product information for diclofenac across Europe in 2013. This study aims to measure its impact among targeted populations. Method: Quarterly interrupted time series regression (ITS) analyses of diclofenac initia...
Article
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Objectives: Previous studies have demonstrated that high-dose allopurinol is able to regress left ventricular (LV) mass in cohorts with established cardiovascular disease. The aim of this study was to assess whether treatment with high-dose allopurinol would regress LV mass in a cohort with essential hypertension, LV hypertrophy and well-controlle...
Article
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Introduction The serotonin 5-HT4 receptor agonist prucalopride is approved in the European Union for the treatment of chronic constipation. This offered the unique opportunity to include real-world observational data on cardiovascular safety in the new drug application for approval of prucalopride in the USA. Methods This observational population-...
Article
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Introduction Given prior safety experience with other 5-HT4 agonists for chronic constipation, an observational, population-based cohort study in five data sources from Germany, Sweden, and the UK was conducted to evaluate the cardiovascular safety of prucalopride. Objectives Our objective is to describe the methods and resulting comparability of...
Article
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Background Recruitment to clinical trials can be challenging. Methods that improve the efficiency of trial recruitment are needed to increase successful study completions. The aim of this study was to ascertain whether sending an audio-visual presentation on a digital versatile disc (DVD), along with usual study invitation materials, would improve...
Article
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Background The Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity stage classifies Chronic Obstructive Pulmonary Disease (COPD) into groups based on symptoms, exacerbations and forced expiratory volume in one second (FEV1). This allows patients to change to less severe COPD stages, a novel aspect of assessment not previously eva...
Article
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Introduction: We will use the existing online mechanisms of the Treatment in Morning versus Evening (TIME) study to collect patient-reported outcome measures of sleep quality to determine whether nocturnal dosing of antihypertensives affects sleep quality, when compared with morning dosing.The TIME study aims to determine if morning or evening dos...
Conference Paper
Background Allopurinol is licensed for the prevention of gout. In recent years, several studies have suggested that allopurinol may have beneficial effects on cardiovascular parameters. The ALL-HEART study is a large outcome trial designed to investigate whether allopurinol improves cardiovascular outcomes in patients with ischaemic heart disease[....
Conference Paper
Background The Febuxostat versus Allopurinol Streamlined Trial (FAST) is a prospective, randomised, open-label, blinded endpoint trial comparing the cardiovascular safety of allopurinol and febuxostat in patients with symptomatic hyperuricaemia.¹ The trial includes patients aged over 60 years who are taking chronic allopurinol therapy at baseline a...
Article
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Background: In the PATHWAY-2 study of resistant hypertension, spironolactone reduced blood pressure substantially more than conventional antihypertensive drugs. We did three substudies to assess the mechanisms underlying this superiority and the pathogenesis of resistant hypertension. Methods: PATHWAY-2 was a randomised, double-blind crossover t...
Article
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Background The use of information technology (IT) is now the preferred method of capturing and storing clinical research data. The Treatment In Morning versus Evening (TIME) study predominantly uses electronic data capture and IT to compare morning dosing of hypertensive medication against evening dosing. Registration, consent, participant demograp...
Data
Table S1. Inclusion and Exclusion Criteria Table S2. Home and Clinic Systolic and Diastolic BP by Study Week: Least Squares Means (95% Confidence Intervals) Adjusted for Baseline Covariates Table S3. HSBP Results for Primary End Point (Average of Weeks 4–32) and Hierarchical Co–Primary End Point at Week 32 by Morning and Evening Home BP Readings...
Article
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Background Guidelines for hypertension vary in their preference for initial combination therapy or initial monotherapy, stratified by patient profile; therefore, we compared the efficacy and tolerability of these approaches. Methods and Results We performed a 1‐year, double‐blind, randomized controlled trial in 605 untreated patients aged 18 to 79...
Article
Full-text available
Clopidogrel efficacy is influenced by genetic variation of CYP2C19, however few studies have considered stroke patients. We used electronic medical records (EMR) linked to a bioresource to examine real-world implications of clopidogrel pharmacogenetics in stroke. Patients hospitalized for any arterial thrombo-occlusive event (ATO) who subsequently...
Article
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Aims: Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underutilised despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. Methods: The revie...
Article
Background Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting. Method Patients aged 60 years and over with osteoar...
Article
OBJECTIVE: To study pregnancy rates after appendectomy and/or tonsillectomy. DESIGN: Population-based cohort study using the United Kingdom (U.K.) primary health care–based Clinical Practice Research Datalink (CPRD). SETTING: Not applicable. PATIENT(S): Female patients who underwent appendectomy, tonsillectomy, or both from 1987 to 2012 and appropr...
Article
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Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART stu...
Article
Background: Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to pa...
Article
Objective: To study pregnancy rates after appendectomy and/or tonsillectomy. Design: Population-based cohort study using the United Kingdom (U.K.) primary health care-based Clinical Practice Research Datalink (CPRD). Setting: Not applicable. Patient(s): Female patients who underwent appendectomy, tonsillectomy, or both from 1987 to 2012 and...
Article
Full-text available
Introduction Nocturnal blood pressure (BP) appears to be a better predictor of cardiovascular outcome than daytime BP. The BP lowering effects of most antihypertensive therapies are often greater in the first 12 h compared to the next 12 h. The Treatment In Morning versus Evening (TIME) study aims to establish whether evening dosing is more cardiop...
Article
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Aims: To investigate whether acid suppression medicines (ASMs) increase the risk of bacterial gastroenteritis. Methods: A population-based, propensity-score matched cohort study using a record-linkage database in Tayside, Scotland. The study consisted of 188,323 exposed to ASMs [proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RA)] a...
Article
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Patient recruitment into clinical trials is a major challenge, and the elderly, socially deprived and those with multiple comorbidities are often underrepresented. The idea of paying patients an incentive to participate in research is controversial, and evidence is needed to evaluate this as a recruitment strategy. In this study, we sought to asses...
Article
Hypertension is the most common preventable cause of cardiovascular disease. Home blood pressure monitoring (HBPM) is a self-monitoring tool that can be incorporated into the care for patients with hypertension and is recommended by major guidelines. A growing body of evidence supports the benefits of patient HBPM compared with office-based monitor...
Article
Full-text available
Potassium depletion by thiazide diuretics is associated with a rise in blood glucose. We assessed whether addition or substitution of a potassium-sparing diuretic, amiloride, can prevent glucose intolerance and improve blood pressure control. Methods We undertook a parallel-group, randomised, double-blind trial in 11 secondary and 2 primary care s...
Article
Full-text available
Aims Spironolactone is widely used to treat heart failure, hypertension and liver disease with increased usage in recent years. Spironolactone has endocrine effects that could influence cancer risks and historical reports suggest possible links with increased risk of certain types of cancer. The aim of this study was to assess the effect of spirono...
Article
Full-text available
Optimal drug treatment for patients with resistant hypertension is undefined. We aimed to test the hypotheses that resistant hypertension is most often caused by excessive sodium retention, and that spironolactone would therefore be superior to non-diuretic add-on drugs at lowering blood pressure. Methods: In this double-blind, placebo-controlle...
Article
Full-text available
Background Potassium depletion by thiazide diuretics is associated with a rise in blood glucose. We assessed whether addition or substitution of a potassium-sparing diuretic, amiloride, can prevent glucose intolerance and improve blood pressure control. Methods We undertook a parallel-group, randomised, double-blind trial in 11 secondary and 2 prim...
Article
Full-text available
Introduction: Resistant hypertension is inadequately controlled blood pressure (BP) despite treatment with at least three BP-lowering drugs. A popular hypothesis is that resistant hypertension is due to excessive Na(+)-retention, and that 'further diuretic therapy' will be superior to alternative add-on drugs. Methods and analysis: Placebo-contr...
Article
Exaggerated blood pressure (BP) response to exercise predicts future hypertension. However, there is considerable lack of understanding regarding the mechanism of how this abnormal response is generated, and how it relates to the future establishment of cardiovascular disease. The authors studied 82 healthy male volunteers without cardiovascular ri...
Article
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Introduction: Thiazide diuretics are associated with increased risk of diabetes mellitus. This risk may arise from K(+)-depletion. We hypothesised that a K(+)-sparing diuretic will improve glucose tolerance, and that combination of low-dose thiazide with K(+)-sparing diuretic will improve both blood pressure reduction and glucose tolerance, compar...
Article
Full-text available
Introduction: Previous studies have suggested that more intensive initial therapy for hypertension results in better long-term blood pressure (BP) control. We test this hypothesis comparing initial monotherapy with dual therapy in the management of essential hypertension. Methods and analysis: The study is a prospective, multicentre, double-blin...