Publications by authors named "Tom Marshall"

183 Publications

Renin-angiotensin system inhibitors and susceptibility to COVID-19 in patients with hypertension: a propensity score-matched cohort study in primary care.

BMC Infect Dis 2021 Mar 15;21(1):262. Epub 2021 Mar 15.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Introduction: Renin-angiotensin system (RAS) inhibitors have been postulated to influence susceptibility to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). This study investigated whether there is an association between their prescription and the incidence of COVID-19 and all-cause mortality.

Methods: We conducted a propensity-score matched cohort study comparing the incidence of COVID-19 among patients with hypertension prescribed angiotensin-converting enzyme I (ACE) inhibitors or angiotensin II type-1 receptor blockers (ARBs) to those treated with calcium channel blockers (CCBs) in a large UK-based primary care database (The Health Improvement Network). We estimated crude incidence rates for confirmed/suspected COVID-19 in each drug exposure group. We used Cox proportional hazards models to produce adjusted hazard ratios for COVID-19. We assessed all-cause mortality as a secondary outcome.

Results: The incidence rate of COVID-19 among users of ACE inhibitors and CCBs was 9.3 per 1000 person-years (83 of 18,895 users [0.44%]) and 9.5 per 1000 person-years (85 of 18,895 [0.45%]), respectively. The adjusted hazard ratio was 0.92 (95% CI 0.68 to 1.26). The incidence rate among users of ARBs was 15.8 per 1000 person-years (79 out of 10,623 users [0.74%]). The adjusted hazard ratio was 1.38 (95% CI 0.98 to 1.95). There were no significant associations between use of RAS inhibitors and all-cause mortality.

Conclusion: Use of ACE inhibitors was not associated with the risk of COVID-19 whereas use of ARBs was associated with a statistically non-significant increase compared to the use of CCBs. However, no significant associations were observed between prescription of either ACE inhibitors or ARBs and all-cause mortality.
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http://dx.doi.org/10.1186/s12879-021-05951-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957446PMC
March 2021

Stroke risk following traumatic brain injury: Systematic review and meta-analysis.

Int J Stroke 2021 Apr 4:17474930211004277. Epub 2021 Apr 4.

NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust and 1724University of Birmingham, Birmingham, UK.

Background: Traumatic brain injury is a global health problem; worldwide, >60 million people experience a traumatic brain injury each year and incidence is rising. Traumatic brain injury has been proposed as an independent risk factor for stroke.

Aims: To investigate the association between traumatic brain injury and stroke risk.

Summary Of Review: We undertook a systematic review of MEDLINE, EMBASE, CINAHL, and The Cochrane Library from inception to 4 December 2020. We used random-effects meta-analysis to pool hazard ratios for studies which reported stroke risk post-traumatic brain injury compared to controls. Searches identified 10,501 records; 58 full texts were assessed for eligibility and 18 met the inclusion criteria. The review included a large sample size of 2,606,379 participants from four countries. Six studies included a non-traumatic brain injury control group, all found traumatic brain injury patients had significantly increased risk of stroke compared to controls (pooled hazard ratio 1.86; 95% confidence interval 1.46-2.37). Findings suggest stroke risk may be highest in the first four months post-traumatic brain injury, but remains significant up to five years post-traumatic brain injury. Traumatic brain injury appears to be associated with increased stroke risk regardless of severity or subtype of traumatic brain injury. There was some evidence to suggest an association between reduced stroke risk post-traumatic brain injury and Vitamin K antagonists and statins, but increased stroke risk with certain classes of antidepressants.

Conclusion: Traumatic brain injury is an independent risk factor for stroke, regardless of traumatic brain injury severity or type. Post-traumatic brain injury review and management of risk factors for stroke may be warranted.
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http://dx.doi.org/10.1177/17474930211004277DOI Listing
April 2021

Factors predicting statin prescribing for primary prevention: a historical cohort study.

Br J Gen Pract 2021 25;71(704):e219-e225. Epub 2021 Feb 25.

Institute of Applied Health Research, University of Birmingham, Birmingham.

Background: Initiation of statins for the primary prevention of cardiovascular disease (CVD) should be based on CVD risk estimates, but their use is suboptimal.

Aim: To investigate the factors influencing statin prescribing when clinicians code and do not code estimated CVD risk (QRISK2).

Design And Setting: A historical cohort of patients who had lipid tests in a database (IQVIA Medical Research Data) of UK primary care records.

Method: The cohort comprised 686 560 entries (lipid test results) between 2012 and 2016 from 383 416 statin-naive patients without previous CVD. Coded QRISK2 scores were extracted, with variables used in calculating QRISK2 and factors that might influence statin prescribing. If a QRISK2 score was not coded, it was calculated post hoc. The outcome was initiation of a statin within 60 days of the lipid test result.

Results: Of the entries, 146 693 (21.4%) had a coded QRISK2 score. Statins were initiated in 6.6% (95% confidence interval [CI] = 6.4% to 6.7%) of those with coded and 4.1% (95% CI = 4.0% to 4.1%) of uncoded QRISK2 (<0.001). Statin initiations were consistent with National Institute for Health and Care Excellence guideline recommendations in 85.0% (95% CI = 84.2% to 85.8%) of coded and 44.2% (95% CI = 43.5% to 44.9%) of uncoded QRISK2 groups (<0.001). When coded, QRISK2 score was the main predictor of statin initiation, but total cholesterol was the main predictor when a QRISK2 score was not coded.

Conclusion: When a QRISK2 score is coded, prescribing is more consistent with guidelines. With no QRISK2 score, prescribing is mainly based on total cholesterol. Using QRISK2 is associated with statin prescribing that is more likely to benefit patients. Promoting the routine CVD risk estimation is essential to optimise decision making.
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http://dx.doi.org/10.3399/bjgp20X714065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888748PMC
February 2021

The Epidemiology of UK Autoimmune Liver Disease Varies With Geographic Latitude.

Clin Gastroenterol Hepatol 2021 Jan 22. Epub 2021 Jan 22.

National Institute for Health Research, Birmingham Biomedical Research Centre, Birmingham, United Kingdom; Division of Gastroenterology and Hepatology, Toronto Centre for Liver Disease, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Background& Aims: The epidemiology of autoimmune liver disease (AILD) is challenging to study because of the diseases' rarity and because of cohort selection bias. Increased incidence farther from the Equator has been reported for multiple sclerosis, another autoimmune disease. We assessed the incidence of primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH) in relation to latitude.

Methods: We performed a retrospective cohort study using anonymized UK primary care records from January 1, 2002, to 2016-05-10. All adults without a baseline diagnosis of AILD were included and followed up until the first occurrence of an AILD diagnosis, death, or they left the database. Latitude was measured as registered general practice rounded down to whole degrees.

Results: The cohort included 8,590,421 records with 53.3 × 10 years of follow-up evaluation from 694 practices. There were 1314 incident cases of PBC, 396 of PSC, and 1034 of AIH. Crude incidences were as follows: PBC, 2.47 (95% CI, 2.34-2.60); PSC, 0.74 (95% CI, 0.67-0.82); and AIH, 1.94 (95% CI, 1.83-2.06) per 100,000 per year. PBC incidence correlated with female sex, smoking, and deprivation; PSC incidence correlated with male sex and nonsmoking; AIH incidence correlated with female sex and deprivation. A more northerly latitude was associated strongly with incidence of PBC: 2.16 (95% CI, 1.79-2.60) to 4.86 (95% CI, 3.93-6.00) from 50°N to 57°N (P = .002) and incidence of AIH: 2.00 (95% CI, 1.65-2.43) to 3.28 (95% CI, 2.53-4.24) (P = .003), but not incidence of PSC: 0.82 (95% CI, 0.60-1.11) to 1.02 (95% CI, 0.64-1.61) (P = .473). Incidence after adjustment for age, sex, smoking, and deprivation status showed similar positive correlations for PBC and AIH with latitude, but not PSC. Incident AIH cases were younger at greater latitude.

Conclusions: We describe an association in the United Kingdom between increased latitude and the incidence of PBC and AIH that requires both confirmation and explanation.
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http://dx.doi.org/10.1016/j.cgh.2021.01.029DOI Listing
January 2021

Phasic modulation of visual representations during sustained attention.

Eur J Neurosci 2020 Dec 15. Epub 2020 Dec 15.

Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, The Netherlands.

Sustained attention has long been thought to benefit perception in a continuous fashion, but recent evidence suggests that it affects perception in a discrete, rhythmic way. Periodic fluctuations in behavioral performance over time, and modulations of behavioral performance by the phase of spontaneous oscillatory brain activity point to an attentional sampling rate in the theta or alpha frequency range. We investigated whether such discrete sampling by attention is reflected in periodic fluctuations in the decodability of visual stimulus orientation from magnetoencephalographic (MEG) brain signals. In this exploratory study, human subjects attended one of the two grating stimuli, while MEG was being recorded. We assessed the strength of the visual representation of the attended stimulus using a support vector machine (SVM) to decode the orientation of the grating (clockwise vs. counterclockwise) from the MEG signal. We tested whether decoder performance depended on the theta/alpha phase of local brain activity. While the phase of ongoing activity in the visual cortex did not modulate decoding performance, theta/alpha phase of activity in the frontal eye fields and parietal cortex, contralateral to the attended stimulus did modulate decoding performance. These findings suggest that phasic modulations of visual stimulus representations in the brain are caused by frequency-specific top-down activity in the frontoparietal attention network, though the behavioral relevance of these effects could not be established.
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http://dx.doi.org/10.1111/ejn.15084DOI Listing
December 2020

Patients' and health professionals' attitudes and perceptions towards the initiation of preventive drugs for primary prevention of cardiovascular disease: a systematic review of qualitative studies.

BJGP Open 2020 Dec 15;4(5). Epub 2020 Dec 15.

Research Fellow, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Background: Statins and antihypertensive agents are recommended for primary prevention of cardiovascular disease (CVD), but they are not always prescribed to eligible patients.

Design & Setting: A systematic review of qualitative studies.

Aim: To explore health professionals' and patients' attitudes towards cardiovascular preventive drugs.

Method: MEDLINE, Embase, PsychINFO, CINAHL, ASSIA, HMIC, Conference Proceedings Citation Index, and Open Grey were searched for studies of qualitative design without restrictions on date or language. Two reviewers performed study selection, data extraction, quality assessment, and thematic synthesis.

Results: In total, 2585 titles and abstracts were screened, yielding 27 studies, of which five met eligibility criteria on full text assessment. These included 62 patients and 47 health professionals. Five themes emerged about patient attitudes: questioning preventive drugs; perceived benefit and risks, such as improving quality of life; patient preferences; trust in health professional judgement; and family, friends, and media influences. Five themes emerged about health professional attitudes: addressing patient concerns and information; duty as a health professional to prescribe; uncertainty about preventive drug prescribing; recognising consequences of prescribing, such as unnecessary medicalisation; and personalised treatment.

Conclusion: The attitudes of patients and health professionals regarding drug initiation for primary prevention reflect the complexity of the patient-health professional encounter in primary practice. For prescribing to be more adherent to guidelines, research should further investigate the patient-health professional relationship and the appropriate communication methods required when discussing drug initiation, specifically for primary prevention.
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http://dx.doi.org/10.3399/bjgpopen20X101087DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7880193PMC
December 2020

Association between the reproductive health of young women and cardiovascular disease in later life: umbrella review.

BMJ 2020 10 7;371:m3502. Epub 2020 Oct 7.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Objective: To consolidate evidence from systematic reviews and meta-analyses investigating the association between reproductive factors in women of reproductive age and their subsequent risk of cardiovascular disease.

Design: Umbrella review.

Data Sources: Medline, Embase, and Cochrane databases for systematic reviews and meta-analyses from inception until 31 August 2019.

Review Methods: Two independent reviewers undertook screening, data extraction, and quality appraisal. The population was women of reproductive age. Exposures were fertility related factors and adverse pregnancy outcomes. Outcome was cardiovascular diseases in women, including ischaemic heart disease, heart failure, peripheral arterial disease, and stroke.

Results: 32 reviews were included, evaluating multiple risk factors over an average follow-up period of 7-10 years. All except three reviews were of moderate quality. A narrative evidence synthesis with forest plots and tabular presentations was performed. Associations for composite cardiovascular disease were: twofold for pre-eclampsia, stillbirth, and preterm birth; 1.5-1.9-fold for gestational hypertension, placental abruption, gestational diabetes, and premature ovarian insufficiency; and less than 1.5-fold for early menarche, polycystic ovary syndrome, ever parity, and early menopause. A longer length of breastfeeding was associated with a reduced risk of cardiovascular disease. The associations for ischaemic heart disease were twofold or greater for pre-eclampsia, recurrent pre-eclampsia, gestational diabetes, and preterm birth; 1.5-1.9-fold for current use of combined oral contraceptives (oestrogen and progesterone), recurrent miscarriage, premature ovarian insufficiency, and early menopause; and less than 1.5-fold for miscarriage, polycystic ovary syndrome, and menopausal symptoms. For stroke outcomes, the associations were twofold or more for current use of any oral contraceptive (combined oral contraceptives or progesterone only pill), pre-eclampsia, and recurrent pre-eclampsia; 1.5-1.9-fold for current use of combined oral contraceptives, gestational diabetes, and preterm birth; and less than 1.5-fold for polycystic ovary syndrome. The association for heart failure was fourfold for pre-eclampsia. No association was found between cardiovascular disease outcomes and current use of progesterone only contraceptives, use of non-oral hormonal contraceptive agents, or fertility treatment.

Conclusions: From menarche to menopause, reproductive factors were associated with cardiovascular disease in women. In this review, presenting absolute numbers on the scale of the problem was not feasible; however, if these associations are causal, they could account for a large proportion of unexplained risk of cardiovascular disease in women, and the risk might be modifiable. Identifying reproductive risk factors at an early stage in the life of women might facilitate the initiation of strategies to modify potential risks. Policy makers should consider incorporating reproductive risk factors as part of the assessment of cardiovascular risk in clinical guidelines.

Systematic Review Registration: PROSPERO CRD42019120076.
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http://dx.doi.org/10.1136/bmj.m3502DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537472PMC
October 2020

Sodium-glucose co-transporter-2 inhibitors and susceptibility to COVID-19: A population-based retrospective cohort study.

Diabetes Obes Metab 2021 01 19;23(1):263-269. Epub 2020 Oct 19.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are widely prescribed in people with type 2 diabetes. We aimed to investigate whether SGLT2 inhibitor prescription is associated with COVID-19, when compared with an active comparator. We performed a propensity-score-matched cohort study with active comparators and a negative control outcome in a large UK-based primary care dataset. Participants prescribed SGLT2 inhibitors (n = 9948) and a comparator group prescribed dipeptidyl peptidase-4 (DPP-4) inhibitors (n = 14 917) were followed up from January 30 to July 27, 2020. The primary outcome was confirmed or clinically suspected COVID-19. The incidence rate of COVID-19 was 19.7/1000 person-years among users of SGLT2 inhibitors and 24.7/1000 person-years among propensity-score-matched users of DPP-4 inhibitors. The adjusted hazard ratio was 0.92 (95% confidence interval 0.66 to 1.29), and there was no evidence of residual confounding in the negative control analysis. We did not observe an increased risk of COVID-19 in primary care amongst those prescribed SGLT2 inhibitors compared to DPP-4 inhibitors, suggesting that clinicians may safely use these agents in the everyday care of people with type 2 diabetes during the COVID-19 pandemic.
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http://dx.doi.org/10.1111/dom.14203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537530PMC
January 2021

National trends in heart failure mortality in men and women, United Kingdom, 2000-2017.

Eur J Heart Fail 2021 Jan 23;23(1):3-12. Epub 2020 Sep 23.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Aims: To understand gender differences in the prognosis of women and men with heart failure, we compared mortality, cause of death and survival trends over time.

Methods And Results: We analysed UK primary care data for 26 725 women and 29 234 men over age 45 years with a new diagnosis of heart failure between 1 January 2000 and 31 December 2017 using the Clinical Practice Research Datalink, inpatient Hospital Episode Statistics and the Office for National Statistics death registry. Age-specific overall survival and cause-specific mortality rates were calculated by gender and year. During the study period 15 084 women and 15 822 men with heart failure died. Women were on average 5 years older at diagnosis (79.6 vs. 74.8 years). Median survival was lower in women compared to men (3.99 vs. 4.47 years), but women had a 14% age-adjusted lower risk of all-cause mortality [hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.84-0.88]. Heart failure was equally likely to be cause of death in women and men (HR 1.03, 95% CI 0.96-1.12). There were modest improvements in survival for both genders, but these were greater in men. The reduction in mortality risk in women was greatest for those diagnosed in the community (HR 0.83, 95% CI 0.80-0.85).

Conclusions: Women are diagnosed with heart failure older than men but have a better age-adjusted prognosis. Survival gains were less in women over the last two decades. Addressing gender differences in heart failure diagnostic and treatment pathways should be a clinical and research priority.
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http://dx.doi.org/10.1002/ejhf.1996DOI Listing
January 2021

Response.

Clin Trials 2020 08 19;17(4):461-462. Epub 2020 May 19.

Rotman Institute of Philosophy, Western University, London, ON, Canada.

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http://dx.doi.org/10.1177/1740774520920578DOI Listing
August 2020

Comorbidity phenotypes and risk of mortality in patients with ischaemic heart disease in the UK.

Heart 2020 06 9;106(11):810-816. Epub 2020 Apr 9.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Objectives: The objective of this study is to use latent class analysis of up to 20 comorbidities in patients with a diagnosis of ischaemic heart disease (IHD) to identify clusters of comorbidities and to examine the associations between these clusters and mortality.

Methods: Longitudinal analysis of electronic health records in the health improvement network (THIN), a UK primary care database including 92 186 men and women aged ≥18 years with IHD and a median of 2 (IQR 1-3) comorbidities.

Results: Latent class analysis revealed five clusters with half categorised as a low-burden comorbidity group. After a median follow-up of 3.2 (IQR 1.4-5.8) years, 17 645 patients died. Compared with the low-burden comorbidity group, two groups of patients with a high-burden of comorbidities had the highest adjusted HR for mortality: those with vascular and musculoskeletal conditions, HR 2.38 (95% CI 2.28 to 2.49) and those with respiratory and musculoskeletal conditions, HR 2.62 (95% CI 2.45 to 2.79). Hazards of mortality in two other groups of patients characterised by cardiometabolic and mental health comorbidities were also higher than the low-burden comorbidity group; HR 1.46 (95% CI 1.39 to 1.52) and 1.55 (95% CI 1.46 to 1.64), respectively.

Conclusions: This analysis has identified five distinct comorbidity clusters in patients with IHD that were differentially associated with risk of mortality. These analyses should be replicated in other large datasets, and this may help shape the development of future interventions or health services that take into account the impact of these comorbidity clusters.
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http://dx.doi.org/10.1136/heartjnl-2019-316091DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282548PMC
June 2020

The use of electronic healthcare records for colorectal cancer screening referral decisions and risk prediction model development.

BMC Gastroenterol 2020 Mar 25;20(1):78. Epub 2020 Mar 25.

Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

Background: The database used for the NHS Bowel Cancer Screening Programme (BCSP) derives participant information from primary care records. Combining predictors with FOBTs has shown to improve referral decisions and accuracy. The richer data available from GP databases could be used to complement screening referral decisions by identifying those at greatest risk of colorectal cancer. We determined the availability of data for key predictors and whether this information could be used to inform more accurate screening referral decisions.

Methods: An English BCSP cohort was derived using the electronic notifications received from the BCSP database to GP records. The cohort covered a period between 13th May 2009 to 17th January 2017. Completeness of variables and univariable associations were assessed. Risk prediction models were developed using Cox regression and multivariable fractional polynomials with backwards elimination. Optimism adjusted performance metrics were reported. The sensitivity and specificity of a combined approach using the negative FOBT model plus FOBT positive patients was determined using a probability equivalent to a 3% PPV NICE guidelines level.

Results: 292,059 participants aged 60-74 were derived for the BCSP screening cohort. A model including the screening test result had a C-statistic of 0.860, c-slope of 0.997, and R of 0.597. A model developed for negative screening results only had a C-statistic of 0.597, c-slope of 0.940, and R of 0.062. Risk predictors included in the models included; age, sex, alcohol consumption, IBS diagnosis, family history of gastrointestinal cancer, smoking status, previous negatives and whether a GP had ordered a blood test. For the combined screening approach, sensitivity increased slightly from 53.90% (FOBT only) to 58.82% but at the expense of an increased referral rate.

Conclusions: This research has identified several potential predictors for CRC in a BCSP population. A risk prediction model developed for BCSP FOBT negative patients was not clinically useful due to a low sensitivity and increased referral rate. The predictors identified in this study should be investigated in a refined algorithm combining the quantitative FIT result. Combining data from multiple sources enables fuller patient profiles using the primary care and screening database interface.
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http://dx.doi.org/10.1186/s12876-020-01206-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7093989PMC
March 2020

The stability of the ADO score among UK COPD patients from The Health Improvement Network.

ERJ Open Res 2020 Jan 10;6(1). Epub 2020 Feb 10.

Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.

The ADO (age, dyspnoea, airflow obstruction) score predicts 3-year overall mortality among chronic obstructive pulmonary disease (COPD) patients. Information on the changes in COPD prognostic scores is sparse and it is unclear if the ADO score should be measured serially. We followed 4804 UK COPD patients with three or more ADO measurements from The Health Improvement Network (2005-2014) in a retrospective open cohort design. Patient's ADO scores were calculated once per year unless an obstruction or dyspnoea measurement was missing. Cox regression models assessed the independent role of serial ADO scores on mortality. The associations between baseline patient characteristics and long-term change in ADO scores were assessed using linear mixed effect models. Fewer than 7% of patients had worsened ( increased) by ≥1 point per year after a median follow-up of 4.4 years. There was strong evidence that patients with more rapid worsening in ADO scores had increased mortality (hazard ratio 2.00 (95% CI 1.59-2.52) per 1 point increase in ADO per year). More rapid ADO score worsening was seen among current smokers (rate difference 0.059 (95% CI 0.031-0.087); p=0.001) and ex-smokers (0.028 (95% CI 0.003-0.054); p=0.032) and patients with depression (0.038 (95% CI 0.005-0.071); p=0.022), while overweight (-0.0347 (95% CI -0.0544- -0.0150); p=0.001) and obese (-0.0412 (95% CI -0.0625- -0.0198); p<0.001) patients had a less rapid ADO score worsening. Serial assessment of the ADO score can identify patients with worsening disease and update their prognosis, especially for patients who smoke, are depressed or have lower body mass index.
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http://dx.doi.org/10.1183/23120541.00196-2019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008137PMC
January 2020

Polypill for prevention of cardiovascular diseases - Authors' reply.

Lancet 2020 02;395(10222):414-415

Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran 1411713135, Iran. Electronic address:

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http://dx.doi.org/10.1016/S0140-6736(19)32966-6DOI Listing
February 2020

Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing: a systematic review and economic evaluation.

Health Technol Assess 2020 01;24(3):1-164

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Background: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with an increased risk of stroke and congestive heart failure. Lead-I electrocardiogram (ECG) devices are handheld instruments that can be used to detect AF at a single time point in people who present with relevant signs or symptoms.

Objective: To assess the diagnostic test accuracy, clinical impact and cost-effectiveness of using single time point lead-I ECG devices for the detection of AF in people presenting to primary care with relevant signs or symptoms, and who have an irregular pulse compared with using manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care.

Data Sources: MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, PubMed, Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects and the Health Technology Assessment Database.

Methods: The systematic review methods followed published guidance. Two reviewers screened the search results (database inception to April 2018), extracted data and assessed the quality of the included studies. Summary estimates of diagnostic accuracy were calculated using bivariate models. An economic model consisting of a decision tree and two cohort Markov models was developed to evaluate the cost-effectiveness of lead-I ECG devices.

Results: No studies were identified that evaluated the use of lead-I ECG devices for patients with signs or symptoms of AF. Therefore, the diagnostic accuracy and clinical impact results presented are derived from an asymptomatic population (used as a proxy for people with signs or symptoms of AF). The summary sensitivity of lead-I ECG devices was 93.9% [95% confidence interval (CI) 86.2% to 97.4%] and summary specificity was 96.5% (95% CI 90.4% to 98.8%). One study reported limited clinical outcome data. Acceptability of lead-I ECG devices was reported in four studies, with generally positive views. The de novo economic model yielded incremental cost-effectiveness ratios (ICERs) per quality-adjusted life-year (QALY) gained. The results of the pairwise analysis show that all lead-I ECG devices generated ICERs per QALY gained below the £20,000-30,000 threshold. Kardia Mobile (AliveCor Ltd, Mountain View, CA, USA) is the most cost-effective option in a full incremental analysis.

Limitations: No published data evaluating the diagnostic accuracy, clinical impact or cost-effectiveness of lead-I ECG devices for the population of interest are available.

Conclusions: Single time point lead-I ECG devices for the detection of AF in people with signs or symptoms of AF and an irregular pulse appear to be a cost-effective use of NHS resources compared with MPP followed by a 12-lead ECG in primary or secondary care, given the assumptions used in the base-case model.

Future Work: Studies assessing how the use of lead-I ECG devices in this population affects the number of people diagnosed with AF when compared with current practice would be useful.

Study Registration: This study is registered as PROSPERO CRD42018090375.

Funding: The National Institute for Health Research Health Technology Assessment programme.
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http://dx.doi.org/10.3310/hta24030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6983912PMC
January 2020

Lead-I ECG for detecting atrial fibrillation in patients attending primary care with an irregular pulse using single-time point testing: A systematic review and economic evaluation.

PLoS One 2019 23;14(12):e0226671. Epub 2019 Dec 23.

Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.

Background: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with increased risk of stroke and congestive heart failure. Lead-I electrocardiogram (ECG) devices are handheld instruments that can detect AF at a single-time point.

Purpose: To assess the diagnostic test accuracy, clinical impact and cost effectiveness of single-time point lead-I ECG devices compared with manual pulse palpation (MPP) followed by a 12-lead ECG for the detection of AF in symptomatic primary care patients with an irregular pulse.

Methods: Electronic databases (MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process, EMBASE, PubMed and Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database) were searched to March 2018. Two reviewers screened the search results, extracted data and assessed study quality. Summary estimates of diagnostic accuracy were calculated using bivariate models. Cost-effectiveness was evaluated using an economic model consisting of a decision tree and two cohort Markov models.

Results: Diagnostic accuracy The diagnostic accuracy (13 publications reporting on nine studies) and clinical impact (24 publications reporting on 19 studies) results are derived from an asymptomatic population (used as a proxy for people with signs or symptoms of AF). The summary sensitivity of lead-I ECG devices was 93.9% (95% confidence interval [CI]: 86.2% to 97.4%) and summary specificity was 96.5% (95% CI: 90.4% to 98.8%). Cost effectiveness The de novo economic model yielded incremental cost effectiveness ratios (ICERs) per quality adjusted life year (QALY) gained. The results of the pairwise analysis show that all lead-I ECG devices generate ICERs per QALY gained below the £20,000-£30,000 threshold. Kardia Mobile is the most cost effective option in a full incremental analysis. Lead-I ECG tests may identify more AF cases than the standard diagnostic pathway. This comes at a higher cost but with greater patient benefit in terms of mortality and quality of life.

Limitations: No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the target population are available.

Conclusions: The use of single-time point lead-I ECG devices in primary care for the detection of AF in people with signs or symptoms of AF and an irregular pulse appears to be a cost effective use of NHS resources compared with MPP followed by a 12-lead ECG, given the assumptions used in the base case model.

Registration: The protocol for this review is registered on PROSPERO as CRD42018090375.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226671PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6927656PMC
April 2020

Stepped-wedge trials should be classified as research for the purpose of ethical review.

Clin Trials 2019 12;16(6):580-588

Rotman Institute of Philosophy, Western University, London, ON, Canada.

Background: All studies classified as research involving human participants require research ethics review. Most regulation and guidance on ethical oversight of research involving human participants was written for pharmacotherapy interventions. Interpretation of such guidance for cluster-randomized trials and stepped-wedge trials, which commonly evaluate complex non-therapeutic interventions such as knowledge translation, public health, or health service delivery interventions, can pose challenges to researchers and regulators.

Current Guidance: The provides guidance on the ethical oversight and consent procedures for cluster-randomized trials, and while not explicit, this includes stepped-wedge trials. Yet, stepped-wedge trials have unique characteristics that differentiate them from standard cluster-randomized trials. In particular, they can be used to evaluate knowledge translation interventions within the context of a routine health system rollout; they may have a non-randomized design; and the decision to implement the intervention is not always made by the researcher. Many stepped-wedge trials do not undergo ethical review and do not report trial registration. This suggests that those undertaking these studies and research ethics committees perceive them as non-research activities.

Recommendations: Through an ethical analysis of two case studies, we argue that stepped-wedge trials, like parallel arm cluster trials, are systematic investigations designed to produce generalizable knowledge. We contend that stepped-wedge trials usually include human research participants, which may be patients, health care providers, or both. Stepped-wedge trials are therefore research involving human participants for the purpose of ethical review. Nevertheless, the use of a waiver or alteration of consent may be appropriate in many stepped-wedge trials due to the infeasibility of obtaining informed consent and the low-risk nature of the interventions. To ensure that traditional ethical principles such as respect for persons are upheld, these studies must undergo research ethics review.
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http://dx.doi.org/10.1177/1740774519873322DOI Listing
December 2019

Temporal variation in the diagnosis of resolved atrial fibrillation and the influence of performance targets on clinical coding: cohort study.

BMJ Open 2019 11 21;9(11):e030454. Epub 2019 Nov 21.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK

Objectives: To investigate whether the introduction of performance targets for anticoagulation in atrial fibrillation (AF) was associated with a change in use of the 'resolved AF' code.

Design: Retrospective cohort studies.

Setting: Data from The Health Improvement Network, a UK database of electronic patient records, from 2000 to 2016.

Participants: 250 788 adult patients aged ≥18 years with a diagnosis of AF, including 14 757 with an incident diagnosis of 'resolved AF'.

Main Outcome Measures: Annual and monthly incidence of 'resolved AF' from 2000 to 2016. Among patients with 'resolved AF', for each year we calculated median duration of the preceding AF diagnosis and the proportion prescribed anticoagulants prior to 'resolved AF'.

Results: Incidence of 'resolved AF' increased from 5.7 to 26.3 per 1000 person-years between 2005 and the introduction of AF performance targets in 2006. Compared with the years prior to the introduction of the performance targets, incidence has remained higher in every year since their implementation. Since 2007, monthly incidence has been highest between January and March. Between 2005 and 2006, median duration between AF and 'resolved AF' diagnoses increased from 276 days (9 months) to 1343 days (3 years 8 months). Among 'resolved AF' patients with CHADS-VASc score ≥1, 81.9% (95% CI 81.1 to 82.6) had no current anticoagulant prescription, and 62.3% (95% CI 61.4 to 63.2) had no record of any anticoagulant prescription.

Conclusion: The introduction of AF performance targets was followed by a large increase in use of the 'resolved AF' code, particularly in the months immediately before practices make their anticoagulant performance target submissions. Although most AF patients are prescribed anticoagulants, few patients diagnosed with 'resolved AF' are prescribed anticoagulants and most have never been prescribed them. Untreated patients are much more likely to be coded as having 'resolved AF'.
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http://dx.doi.org/10.1136/bmjopen-2019-030454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887086PMC
November 2019

Adherence and persistence to direct oral anticoagulants in atrial fibrillation: a population-based study.

Heart 2020 01 10;106(2):119-126. Epub 2019 Oct 10.

Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.

Background: Despite simpler regimens than vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), adherence (taking drugs as prescribed) and persistence (continuation of drugs) to direct oral anticoagulants are suboptimal, yet understudied in electronic health records (EHRs).

Objective: We investigated (1) time trends at individual and system levels, and (2) the risk factors for and associations between adherence and persistence.

Methods: In UK primary care EHR (The Health Information Network 2011-2016), we investigated adherence and persistence at 1 year for oral anticoagulants (OACs) in adults with incident AF. Baseline characteristics were analysed by OAC and adherence/persistence status. Risk factors for non-adherence and non-persistence were assessed using Cox and logistic regression. Patterns of adherence and persistence were analysed.

Results: Among 36 652 individuals with incident AF, cardiovascular comorbidities (median CHADSVASc[Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category] 3) and polypharmacy (median number of drugs 6) were common. Adherence was 55.2% (95% CI 54.6 to 55.7), 51.2% (95% CI 50.6 to 51.8), 66.5% (95% CI 63.7 to 69.2), 63.1% (95% CI 61.8 to 64.4) and 64.7% (95% CI 63.2 to 66.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. One-year persistence was 65.9% (95% CI 65.4 to 66.5), 63.4% (95% CI 62.8 to 64.0), 61.4% (95% CI 58.3 to 64.2), 72.3% (95% CI 70.9 to 73.7) and 78.7% (95% CI 77.1 to 80.1) for all OACs, VKA, dabigatran, rivaroxaban and apixaban. Risk of non-adherence and non-persistence increased over time at individual and system levels. Increasing comorbidity was associated with reduced risk of non-adherence and non-persistence across all OACs. Overall rates of 'primary non-adherence' (stopping after first prescription), 'non-adherent non-persistence' and 'persistent adherence' were 3.5%, 26.5% and 40.2%, differing across OACs.

Conclusions: Adherence and persistence to OACs are low at 1 year with heterogeneity across drugs and over time at individual and system levels. Better understanding of contributory factors will inform interventions to improve adherence and persistence across OACs in individuals and populations.
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http://dx.doi.org/10.1136/heartjnl-2019-315307DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6993026PMC
January 2020

Hemispheric Asymmetry of Globus Pallidus Relates to Alpha Modulation in Reward-Related Attentional Tasks.

J Neurosci 2019 11 2;39(46):9221-9236. Epub 2019 Oct 2.

Centre for Human Brain Health, School of Psychology, University of Birmingham, B15 2TT Birmingham, United Kingdom.

Whereas subcortical structures such as the basal ganglia have been widely explored in relation to motor control, recent evidence suggests that their mechanisms extend to the domain of attentional switching. We here investigated the subcortical involvement in reward related top-down control of visual alpha-band oscillations (8-13 Hz), which have been consistently linked to mechanisms supporting the allocation of visuospatial attention. Given that items associated with contextual saliency (e.g., monetary reward or loss) attract attention, it is not surprising that the acquired salience of visual items further modulates. The executive networks controlling such reward-dependent modulations of oscillatory brain activity have yet to be fully elucidated. Although such networks have been explored in terms of corticocortical interactions, subcortical regions are likely to be involved. To uncover this, we combined MRI and MEG data from 17 male and 11 female participants, investigating whether derived measures of subcortical structural asymmetries predict interhemispheric modulation of alpha power during a spatial attention task. We show that volumetric hemispheric lateralization of globus pallidus (GP) and thalamus (Th) explains individual hemispheric biases in the ability to modulate posterior alpha power. Importantly, for the GP, this effect became stronger when the value saliency parings in the task increased. Our findings suggest that the GP and Th in humans are part of a subcortical executive control network, differentially involved in modulating posterior alpha activity in the presence of saliency. Further investigation aimed at uncovering the interaction between subcortical and neocortical attentional networks would provide useful insight in future studies. Whereas the involvement of subcortical regions into higher level cognitive processing, such as attention and reward attribution, has been already indicated in previous studies, little is known about its relationship with the functional oscillatory underpinnings of said processes. In particular, interhemispheric modulation of alpha band (8-13 Hz) oscillations, as recorded with magnetoencephalography, has been previously shown to vary as a function of salience (i.e., monetary reward/loss) in a spatial attention task. We here provide novel insights into the link between subcortical and cortical control of visual attention. Using the same reward-related spatial attention paradigm, we show that the volumetric lateralization of subcortical structures (specifically globus pallidus and thalamus) explains individual biases in the modulation of visual alpha activity.
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http://dx.doi.org/10.1523/JNEUROSCI.0610-19.2019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855688PMC
November 2019

Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial.

Lancet 2019 08;394(10199):672-683

Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran; Digestive Oncology Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran; Liver and Pancreaticobiliary Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address:

Background: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease.

Methods: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985.

Findings: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; p=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group.

Interpretation: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs.

Funding: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou.
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http://dx.doi.org/10.1016/S0140-6736(19)31791-XDOI Listing
August 2019

Multimorbidity and emergency department visits by a homeless population: a database study in specialist general practice.

Br J Gen Pract 2019 Aug 1;69(685):e515-e525. Epub 2019 Jul 1.

University of Birmingham, Birmingham.

Background: Estimating healthcare needs of the homeless is associated with challenges in identifying the eligible population.

Aim: To explore the demographic characteristics, disease prevalence, multimorbidity, and emergency department visits of the homeless population.

Design And Setting: EMIS electronic database of patient medical records and Quality and Outcomes Framework (QOF) data of all 928 patients registered with a major specialist homeless primary healthcare centre based in the West Midlands in England, from the period of October 2016 to 11 October 2017.

Method: Prevalence data on 21 health conditions, multimorbidity, and visits to emergency departments were explored and compared with the general population datasets.

Results: Most homeless people identified were male (89.5%), with a mean age of 38.3 (SD = 11.5) years, and of white British origin (22.1%). Prevalence of substance (13.5%) and alcohol dependence (21.3%), hepatitis C (6.3%), and multimorbidity (21.3%) were markedly higher than in the general population. A third (32.5%) had visited the emergency department in the preceding 12 months. Emergency department visits were associated with a patient history of substance (odds ratio [OR] = 2.69) and alcohol dependence (OR = 3.14).

Conclusion: A high prevalence of substance and alcohol dependence, and hepatitis C, exists among the homeless population. Their emergency department visit rate is 60 times that of the general population and the extent of multimorbidity, despite their lower mean age, is comparable with that of 60-69-year-olds in the general population. Because of multimorbidity, homeless people are at risk of fragmentation of care. Diversification of services under one roof, preventive services, and multidisciplinary care are imperative.
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http://dx.doi.org/10.3399/bjgp19X704609DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6607834PMC
August 2019

Raincloud plots: a multi-platform tool for robust data visualization.

Wellcome Open Res 2019 1;4:63. Epub 2019 Apr 1.

MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.

Across scientific disciplines, there is a rapidly growing recognition of the need for more statistically robust, transparent approaches to data visualization. Complementary to this, many scientists have called for plotting tools that accurately and transparently convey key aspects of statistical effects and raw data with minimal distortion. Previously common approaches, such as plotting conditional mean or median barplots together with error-bars have been criticized for distorting effect size, hiding underlying patterns in the raw data, and obscuring the assumptions upon which the most commonly used statistical tests are based. Here we describe a data visualization approach which overcomes these issues, providing maximal statistical information while preserving the desired 'inference at a glance' nature of barplots and other similar visualization devices. These "raincloud plots" can visualize raw data, probability density, and key summary statistics such as median, mean, and relevant confidence intervals in an appealing and flexible format with minimal redundancy. In this tutorial paper, we provide basic demonstrations of the strength of raincloud plots and similar approaches, outline potential modifications for their optimal use, and provide open-source code for their streamlined implementation in R, Python and Matlab ( https://github.com/RainCloudPlots/RainCloudPlots). Readers can investigate the R and Python tutorials interactively in the browser using Binder by Project Jupyter.
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http://dx.doi.org/10.12688/wellcomeopenres.15191.1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6480976PMC
April 2019

Patient and Clinician Perspectives on Electronic Patient-Reported Outcome Measures in the Management of Advanced CKD: A Qualitative Study.

Am J Kidney Dis 2019 08 16;74(2):167-178. Epub 2019 Apr 16.

Centre for Patient Reported Outcomes Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom; Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom.

Rationale & Objective: Chronic kidney disease (CKD) can substantially affect patients' health-related quality of life. Electronic patient-reported outcome measures (ePROMs) may capture symptoms and health-related quality of life and assist in the management of CKD. This study explored patient and clinician views on the use of a renal ePROM system.

Study Design: Qualitative study.

Setting & Participants: 12 patients with stage 4 or 5 CKD (non-dialysis dependent); 22 clinicians (6 CKD community nurses, 1 clinical psychologist, 10 nephrologists, 3 specialist registrars, and 2 renal surgeons) in the United Kingdom.

Analytical Approach: Semi-structured interviews and focus group discussion during which patients received paper versions of the Kidney Disease Quality of Life-36 and the Integrated Patient Outcome Scale-Renal to exemplify the type of content that could be included in an ePROM. Thematic analysis of interview transcripts.

Results: 4 themes were identified: (1) general opinions of PROMs, (2) potential benefits and applications of an ePROM system, (3) practical considerations for the implementation of ePROMs, and (4) concerns, barriers, and facilitators. Patients were willing to complete ePROMs on a regular basis as part of their care despite clinician concerns about patient burden. Patients assessed the questionnaires favorably. Clinicians suggested that the extent of adoption of renal ePROM systems in routine clinical settings should be based on evidence of significant impact on patient outcomes. Clinicians were concerned that an ePROM system may raise patient expectations to unrealistic levels and expose clinicians to the risk for litigation. Patients and clinicians identified potential benefits and highlighted issues and concerns that need to be addressed to ensure the successful implementation of the renal ePROM system.

Limitations: Transferability of the findings may be limited because only English-speaking participants were recruited to the study.

Conclusions: A renal ePROM system may play a supportive role in the routine clinical management of patients with advanced CKD if the concerns of clinicians and patients can be sufficiently addressed.
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http://dx.doi.org/10.1053/j.ajkd.2019.02.011DOI Listing
August 2019

Patients' and health professionals' attitudes and perceptions towards the initiation of preventive drugs for primary prevention of cardiovascular disease: protocol for a systematic review of qualitative studies.

BMJ Open 2019 04 11;9(4):e025587. Epub 2019 Apr 11.

Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK.

Introduction: Lipid-lowering drugs and antihypertensive agents can be prescribed for the primary prevention of cardiovascular disease. In some cases, patients eligible for primary prevention of cardiovascular disease according to the European guidelines are not always started on preventive drugs. Existing research explores the attitudes of health professionals and patients towards cardiovascular preventive drugs but does not always differentiate between the attitudes towards drug initiation for primary or secondary prevention. We aim to systematically review qualitative studies assessing health professionals' and patients' attitudes and perceptions towards drug initiation for primary prevention of cardiovascular disease.

Methods And Analysis: MEDLINE, MEDLINE In Process, EMBASE, PsycINFO, CINAHL, Applied Social Sciences Index and Abstracts, Conference Proceedings Citation Index (Web of Science), Healthcare Management Information Consortium, and Open Grey will be searched without restrictions on date or language of publication. Searches will be limited to studies of qualitative design, standalone or in the context of a mixed-method design, focusing on cardiovascular drug initiation for primary prevention. The primary outcome is the attitudes of health professionals and patients towards drug initiation for primary prevention of cardiovascular disease. Two reviewers will independently carry out the study selection, data extraction and quality assessment. The Critical Appraisal Skills Programme Qualitative Research Checklist will be used to assess the quality of included studies. The findings will be analysed using Thomas and Harden's thematic synthesis approach.

Ethics And Dissemination: This systematic review does not require ethical approval as primary data will not be collected. The results of the study will be published in a peer-reviewed journal and presented at relevant conferences.

Prospero Registration Number: CRD42018095346.
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http://dx.doi.org/10.1136/bmjopen-2018-025587DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500290PMC
April 2019

Fear of complaints.

Authors:
Tom Marshall

BMJ 2019 03 15;364:l1147. Epub 2019 Mar 15.

University of Birmingham, Birmingham B15 2TT, UK.

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http://dx.doi.org/10.1136/bmj.l1147DOI Listing
March 2019

Trends in survival after a diagnosis of heart failure in the United Kingdom 2000-2017: population based cohort study.

BMJ 2019 02 13;364:l223. Epub 2019 Feb 13.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.

Objectives: To report reliable estimates of short term and long term survival rates for people with a diagnosis of heart failure and to assess trends over time by year of diagnosis, hospital admission, and socioeconomic group.

Design: Population based cohort study.

Setting: Primary care, United Kingdom.

Participants: Primary care data for 55 959 patients aged 45 and overwith a new diagnosis of heart failure and 278 679 age and sex matched controls in the Clinical Practice Research Datalink from 1 January 2000 to 31 December 2017 and linked to inpatient Hospital Episode Statistics and Office for National Statistics mortality data.

Main Outcome Measures: Survival rates at one, five, and 10 years and cause of death for people with and without heart failure; and temporal trends in survival by year of diagnosis, hospital admission, and socioeconomic group.

Results: Overall, one, five, and 10 year survival rates increased by 6.6% (from 74.2% in 2000 to 80.8% in 2016), 7.2% (from 41.0% in 2000 to 48.2% in 2012), and 6.4% (from 19.8% in 2000 to 26.2% in 2007), respectively. There were 30 906 deaths in the heart failure group over the study period. Heart failure was listed on the death certificate in 13 093 (42.4%) of these patients, and in 2237 (7.2%) it was the primary cause of death. Improvement in survival was greater for patients not requiring admission to hospital around the time of diagnosis (median difference 2.4 years; 5.3 2.9 years, P<0.001). There was a deprivation gap in median survival of 0.5 years between people who were least deprived and those who were most deprived (4.6 v 4.1 years, P<0.001) [corrected].

Conclusions: Survival after a diagnosis of heart failure has shown only modest improvement in the 21st century and lags behind other serious conditions, such as cancer. New strategies to achieve timely diagnosis and treatment initiation in primary care for all socioeconomic groups should be a priority for future research and policy.
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http://dx.doi.org/10.1136/bmj.l223DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372921PMC
February 2019

Alpha and alpha-beta phase synchronization mediate the recruitment of the visuospatial attention network through the Superior Longitudinal Fasciculus.

Neuroimage 2019 03 31;188:722-732. Epub 2018 Dec 31.

Department of Neuroscience, Imaging and Clinical Sciences, "G. D'Annunzio University" of Chieti-Pescara, 66100, Chieti, Italy; Institute for Advanced Biomedical Technologies, "G. D'Annunzio University" of Chieti-Pescara, 66100, Chieti, Italy. Electronic address:

It is well known that attentional selection of relevant information relies on local synchronization of alpha band neuronal oscillations in visual cortices for inhibition of distracting inputs. Additionally, evidence for long-range coupling of neuronal oscillations between visual cortices and regions engaged in the anticipation of upcoming stimuli has been more recently provided. Nevertheless, on the one hand the relation between long-range functional coupling and anatomical connections is still to be assessed, and, on the other hand, the specific role of the alpha and beta frequency bands in the different processes underlying visuo-spatial attention still needs further clarification. We address these questions using measures of linear (frequency-specific) and nonlinear (cross-frequency) phase-synchronization in a cohort of 28 healthy subjects using magnetoencephalography. We show that alpha band phase-synchronization is modulated by the orienting of attention according to a parieto-occipital top-down mechanism reflecting behavior, and its hemispheric asymmetry is predicted by volume's asymmetry of specific tracts of the Superior-Longitudinal-Fasciculus. We also show that a network comprising parietal regions and the right putative Frontal-Eye-Field, but not the left, is recruited in the deployment of spatial attention through an alpha-beta cross-frequency coupling. Overall, we demonstrate that the visuospatial attention network features subsystems indexed by characteristic spectral fingerprints, playing different functional roles in the anticipation of upcoming stimuli and with diverse relation to fiber tracts.
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http://dx.doi.org/10.1016/j.neuroimage.2018.12.056DOI Listing
March 2019

Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice.

Br J Gen Pract 2018 Dec 5;68(677):e844-e851. Epub 2018 Nov 5.

Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford.

Background: Oral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.

Aim: To investigate the implementation of the software in UK general practice.

Design And Setting: Process evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.

Method: An initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.

Results: In a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.

Conclusion: Automated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.
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http://dx.doi.org/10.3399/bjgp18X699809DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6255240PMC
December 2018

Incidence of indications for tonsillectomy and frequency of evidence-based surgery: a 12-year retrospective cohort study of primary care electronic records.

Br J Gen Pract 2019 Jan 5;69(678):e33-e41. Epub 2018 Nov 5.

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Background: Neither the incidence of indications for childhood tonsillectomy nor the proportion of tonsillectomies that are evidence-based is known.

Aim: To determine the incidence of indications for tonsillectomy in UK children, and the proportion of tonsillectomies meeting evidence-based criteria.

Design And Setting: A retrospective cohort study of electronic medical records of children aged 0-15 years registered with 739 UK general practices contributing to a research database.

Method: Children with recorded indications for tonsillectomy were identified from electronic medical records. Evidence-based indications included documented sore throats of sufficient frequency and severity (Paradise criteria); periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis syndrome (PFAPA); or tonsillar tumour. Other indications were considered non-evidence-based. The numbers of children subsequently undergoing tonsillectomy was then identified. The numbers with evidence-based and non-evidence-based indications for surgery among children who had undergone tonsillectomy were determined.

Results: The authors included 1 630 807 children followed up for 7 200 159 person-years between 2005 and 2016. Incidence of evidence-based indications for tonsillectomy was 4.2 per 1000 person years; 13.6% (2144/15 760) underwent tonsillectomy. Incidence of childhood tonsillectomy was 2.5 per 1000 person years; 11.7% (2144/18 281) had evidence-based indications, almost all with Paradise criteria. The proportion of evidence-based tonsillectomies was unchanged over 12 years. Most childhood tonsillectomies followed non-evidence-based indications: five to six sore throats (12.4%) in 1 year, two to four sore throats (44.6%) in 1 year, sleep disordered breathing (12.3%), or obstructive sleep apnoea (3.9%).

Conclusion: In the UK, few children with evidence-based indications undergo tonsillectomy and seven in eight of those who do (32 500 of 37 000 annually) are unlikely to benefit.
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http://dx.doi.org/10.3399/bjgp18X699833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6301361PMC
January 2019