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© 2018 Elsevier Inc. Scientific research indicates that open-label and dose-extending placebos (that patients know are placebos) can elicit behavioral, biological, and clinical outcome changes. In this chapter, we present the state-of-the-art evidence and ethical considerations about open-label and dose-extending placebos, discussing the perspective of giving placebos with a rational, as dose extension of active drugs, or expectancy boosters. Previous comprehensive reviews of placebo use have considered how to harness placebo effects in medicine and the need to focus on elements of the clinical encounter as well as patient–clinician relations. Here, we illustrate the similarities and differences between standard (deceptive) placebos, open-label placebos and dose-extending placebos. We conclude that placebos without deception would override ethical barriers to their clinical use. This paves the way to future large-scale, pragmatic randomized trials that investigate the potential of ethical open-label and dose-extending placebos to improve patients’ outcomes, and reduce side effects.
Trends in survival after a diagnosis of heart failure in the United Kingdom 2000-2017: population based cohort study
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. 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 v 2.9 years, P<0.001). There was a deprivation gap in median survival of 2.4 years between people who were least deprived and those who were most deprived (11.1 v 8.7 years, P<0.001). 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.
Association between heart rate variability and haemodynamic response to exercise in chronic heart failure.
OBJECTIVES: Heart rate variability (HRV) and haemodynamic response to exercise (i.e. peak cardiac power output) are strong predictors of mortality in heart failure. The present study assessed the relationship between measures of HRV and peak cardiac power output. DESIGN: In a prospective observational study of 33 patients (age 54 ± 16 years) with chronic heart failure with reduced left ventricular ejection fraction (29 ± 11%), measures of the HRV (i.e. R-R interval and standard deviation of normal R-R intervals, SDNN) were recorded in a supine position. All patients underwent maximal graded cardiopulmonary exercise testing with non-invasive (inert gas rebreathing) cardiac output assessment. Cardiac power output, expressed in watts, was calculated as the product of cardiac output and mean arterial blood pressure. RESULTS: The mean RR and SDNN were 837 ± 166 and 96 ± 29 ms, peak exercise cardiac power output 2.28 ± 0.85 watts, cardiac output 10.34 ± 3.14 l/min, mean arterial blood pressure 98 ± 14 mmHg, stroke volume 91.43 ± 40.77 ml/beat, and oxygen consumption 19.0 ± 5.6 ml/kg/min. There was a significant but only moderate relationship between the RR interval and peak exercise cardiac power output (r = 0.43, p = 0.013), cardiac output (r = 0.35, p = 0.047), and mean arterial blood pressure (r = 0.45, p = 0.009). The SDNN correlated with peak cardiac power output (r = 0.42, p = 0.016), mean arterial blood arterial (r = 0.41, p = 0.019), and stroke volume (r = 0.35, p = 0.043). CONCLUSIONS: Moderate strength of the relationship between measures of HRV and cardiac response to exercise suggests that cardiac autonomic function is not good indicator of overall function and pumping capability of the heart in chronic heart failure.
How does exercise treatment compare with antihypertensive medications? A network meta-analysis of 391 randomised controlled trials assessing exercise and medication effects on systolic blood pressure
© Author(s) (or their employer(s)) 2018. No commercial re-use. See rights and permissions. Published by BMJ. Objective: To compare the effect of exercise regimens and medications on systolic blood pressure (SBP). Data sources: Medline (via PubMed) and the Cochrane Library. Eligibility criteria: Randomised controlled trials (RCTs) of angiotensin-converting enzyme inhibitors (ACE-I), angiotensin-2 receptor blockers (ARBs), β-blockers, calcium channel blockers (CCBs) and diuretics were identified from existing Cochrane reviews. A previously published meta-analysis of exercise interventions was updated to identify recent RCTs that tested the SBP-lowering effects of endurance, dynamic resistance, isometric resistance, and combined endurance and resistance exercise interventions (up to September 2018). Design: Random-effects network meta-analysis. Outcome: Difference in mean change from baseline SBP between comparator treatments (change from baseline in one group minus that in the other group) and its 95% credible interval (95% CrI), measured in mmHg. Results: We included a total of 391 RCTs, 197 of which evaluated exercise interventions (10 461 participants) and 194 evaluated antihypertensive medications (29 281 participants). No RCTs compared directly exercise against medications. While all medication trials included hypertensive populations, only 56 exercise trials included hypertensive participants (≥140 mmHg), corresponding to 3508 individuals. In a 10% random sample, risk of bias was higher in exercise RCTs, primarily due to lack of blinding and incomplete outcome data. In analyses that combined all populations, antihypertensive medications achieved higher reductions in baseline SBP compared with exercise interventions (mean difference 3.96 mmHg, 95% CrI 5.02 to 2.91). Compared with control, all types of exercise (including combination of endurance and resistance) and all classes of antihypertensive medications were effective in lowering baseline SBP. Among hypertensive populations, there were no detectable differences in the SBP-lowering effects of ACE-I, ARB, β-blocker and diuretic medications when compared with endurance or dynamic resistance exercise. There was no detectable inconsistency between direct and indirect comparisons. Although there was evidence of small-study effects, this affected both medication and exercise trials. Conclusions: The effect of exercise interventions on SBP remains under-studied, especially among hypertensive populations. Our findings confirm modest but consistent reductions in SBP in many studied exercise interventions across all populations but individuals receiving medications generally achieved greater reductions than those following structured exercise regimens. Assuming equally reliable estimates, the SBP-lowering effect of exercise among hypertensive populations appears similar to that of commonly used antihypertensive medications. Generalisability of these findings to real-world clinical settings should be further evaluated.
Recently there has been an increased interest cross-linguistically in how speakers use interjections in everyday interaction. A particularly productive line of inquiry deals with what are known as change-of-state tokens, interjections with which speakers claim that there has been a shift in their cognitive state such as their knowledge, understanding, attention, etc. In this paper I explore the variability of the Dutch interjection oh /o/. Focusing on its use in response to informing turns, I argue that as a free-standing particle speakers use it to claim that the information in that prior turn was in some way unexpected: either because it contradicted what the speaker claimed he or she knew, or because it contradicted some presupposition that was encoded in an earlier question. I subsequently discuss the most frequent ways in which oh is combined with other turn components, showing how it is used to respond to announcements of valenced news, to do now-remembering, and to make claims of now-understanding. In closing I show that when oh prefaces additional turn components such as oké, each component deals with a different action-implication of the ongoing sequence and that oh is used to receive the information being conveyed.
Prognosis versus Diagnosis and Test Accuracy versus Risk Estimation: Exploring the Clinical Application of the HEART Score.
In this issue, Fernando et al present a systematic review and meta-analysis assessing the prognostic accuracy of the HEART score for prediction of major adverse cardiac events (MACE) in adult patients presenting with chest pain at the emergency department (ED).1 The authors conclude that the HEART score has excellent performance for prediction of MACE (particularly mortality and myocardial infarction) in chest pain patients and should be the primary clinical decision instrument used for risk-stratification of this patient population. This article is protected by copyright. All rights reserved.
The HEART score in predicting major adverse cardiac events in patients presenting to the emergency department with possible acute coronary syndrome: Protocol for a systematic review and meta-analysis 11 Medical and Health Sciences 1117 Public Health and Health Services 11 Medical and Health Sciences 1102 Cardiorespiratory Medicine and Haematology
© 2018 The Author(s). Background: Acute coronary syndrome (ACS) is a common, sometimes difficult to diagnose spectrum of diseases occurring after abrupt reduction in blood flow through a coronary artery. Given the diagnostic challenge, it is sensible for emergency physicians to have an approach to prognosticate patients with possible ACS. Multiple prediction models have been developed to help identify patients at increased risk of adverse outcomes. The HEART score is the first model to be derived, validated, and undergo clinical impact studies in emergency department (ED) patients with possible ACS. Objective: To develop a protocol for a prognostic systematic review of the literature evaluating the HEART score as a predictor of major adverse cardiac events (MACE) in patients presenting to the ED with possible ACS. Methods/design: This protocol is reported according to the PRISMA-P statement and is registered on PROSPERO. All methodological tools to be used are endorsed by the Cochrane Prognosis Methods Group. Pre-defined eligibility criteria are provided. Multiple strategies will be used to identify potentially relevant studies. Studies will be selected and data extracted using standardised forms based on the CHARMS checklist. The QUIPS tool will be used to assess the risk of bias within individual studies. Outcome measures will include prevalence, risk ratio, and absolute risk reduction for MACE within 6 weeks of ED evaluation, comparing HEART scores 0-3 versus 4-10. HEART score prognostic performance will be evaluated with the concordance (C) statistic (model discrimination), observed to expected events ratio (model calibration), and a decision curve analysis. Reporting biases and methodological, clinical, and statistical heterogeneity will be scrutinised. Unless deemed inappropriate, a meta-analysis and pre-defined subgroup and sensitivity analyses will be performed. Overall judgements about evidence quality and strength of recommendations will be summarised using the GRADE approach. Discussion: This review will identify, select, and appraise studies evaluating the prognostic performance of the HEART score, producing results of interest to emergency physicians. These results may encourage shared clinical decision-making in the ED by facilitating risk communication with patients and health care providers.
© 2019, The Author(s), under exclusive licence to Springer Nature America, Inc. Insomnia is a common disorder linked with adverse long-term medical and psychiatric outcomes. The underlying pathophysiological processes and causal relationships of insomnia with disease are poorly understood. Here we identified 57 loci for self-reported insomnia symptoms in the UK Biobank (n = 453,379) and confirmed their effects on self-reported insomnia symptoms in the HUNT Study (n = 14,923 cases and 47,610 controls), physician-diagnosed insomnia in the Partners Biobank (n = 2,217 cases and 14,240 controls), and accelerometer-derived measures of sleep efficiency and sleep duration in the UK Biobank (n = 83,726). Our results suggest enrichment of genes involved in ubiquitin-mediated proteolysis and of genes expressed in multiple brain regions, skeletal muscle, and adrenal glands. Evidence of shared genetic factors was found between frequent insomnia symptoms and restless legs syndrome, aging, and cardiometabolic, behavioral, psychiatric, and reproductive traits. Evidence was found for a possible causal link between insomnia symptoms and coronary artery disease, depressive symptoms, and subjective well-being.
Erratum: Correction to: Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature (BMC medicine (2016) 14 (10))
The original article  contains a minor error whereby the dates for year of first launch and year of first report of adverse reaction for iophendylate in e-Appendix Table 1 are mistakenly presented as 1946 and 1975 respectively.
Associations between the household environment and stunted child growthin rural India: a cross-sectional analysis
Stunting is a major unresolved and growing health issue for India. Yet there remains scant evidence for the development and application of integrated, multifactorial child health interventions across India’s most rural communities. We examine the associations between household environmental characteristics and stunting in children under 5 years across rural Rajasthan, India. We used DHS-3 India data from 1194 children living across 109,041 interviewed households. Multiple logistic regression analyses independently examined the association between (1) main source of drinking water, (2) main type of sanitation facilities, (3) main cooking fuel type, and (4) agricultural land ownership and stunting adjusting for child age. After adjusting for child age, household access to (1) improved drinking water source was associated with a 23% reduced odds (OR=0·77, 95% CI 0·5 to 1·00), (2) improved sanitation facility was associated with 41% reduced odds (OR=0·51, 95% CI 0·3 to 0·82), and (3) agricultural land ownership was associated with a 30% reduced odds of childhood stunting (OR 0·70, 95% CI 0·51 to 0·94). Cooking fuel source was not associated with stunting. Although further research is needed, intervention programmes should consider shifting from nutrition-specific to nutrition-sensitive solutions to address India’s childhood malnutrition crisis. Results and implications are discussed.
© 2014 American College of Emergency Physicians. Study objective: We examine acute stroke patients' decisions and delays en route to the hospital after onset of symptoms. Methods: This was a qualitative study carried out in the West Midlands, United Kingdom. Semistructured interviews were conducted with 30 patients (6 accompanied by partners). Patients were asked about their previous experience of having had a stroke and their initial engagement with health services. "One sheet of paper" and thematic analyses were used. Results: Three potential types of delay were identified from onset of symptoms to accessing stroke care in the hospital: primary delays caused by lack of recognition of symptoms or not dealing with symptoms immediately, secondary delays caused by initial contact with nonemergency services, and tertiary delays in which health service providers did not interpret the patients' presenting symptoms as suggestive of stroke. The main factors determining the speed of action by patients were the presence and influence of a bystander and the perceived seriousness of symptoms. Conclusion: Despite campaigns to increase public awareness of stroke symptoms, the behavior of both patients and health service providers apparently led to delays in the recognition of and response to stroke symptoms, potentially reducing access to optimum and timely acute specialist assessment and treatment for acute stroke.
© 2014 American College of Emergency Physicians. Study objective We examine acute stroke patients' decisions and delays en route to the hospital after onset of symptoms. Methods This was a qualitative study carried out in the West Midlands, United Kingdom. Semistructured interviews were conducted with 30 patients (6 accompanied by partners). Patients were asked about their previous experience of having had a stroke and their initial engagement with health services. "One sheet of paper" and thematic analyses were used. Results Three potential types of delay were identified from onset of symptoms to accessing stroke care in the hospital: primary delays caused by lack of recognition of symptoms or not dealing with symptoms immediately, secondary delays caused by initial contact with nonemergency services, and tertiary delays in which health service providers did not interpret the patients' presenting symptoms as suggestive of stroke. The main factors determining the speed of action by patients were the presence and influence of a bystander and the perceived seriousness of symptoms. Conclusion Despite campaigns to increase public awareness of stroke symptoms, the behavior of both patients and health service providers apparently led to delays in the recognition of and response to stroke symptoms, potentially reducing access to optimum and timely acute specialist assessment and treatment for acute stroke.
Computerized decision: support systems (CDSS) are available to assist clinicians in the therapeutic management of oral anticoagulation. We report the findings relating to CDSS for oral anticoagulation management of a primary-care-based systematic review which largely focused on near-patient testing. Seven papers were reviewed which covered four different systems. The methodology of these papers was generally poor, although one randomized controlled trial showed improved therapeutic control associated with computerized management compared with human performance.
Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial
© 2019, Springer Nature Limited. Background: The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. Methods: Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. Results: Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. Conclusions: A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m2 reduces healthcare costs and improves health more than advising weight loss.
Is Doctor Referral to a Low-Energy Total Diet Replacement Program Cost-Effective for the Routine Treatment of Obesity?
© 2019 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS) Objective: The study objective was to estimate the cost-effectiveness of a commercially provided low-energy total diet replacement (TDR) program compared with nurse-led behavioral support. Methods: A multistate life table model and the weight reduction observed in a randomized controlled trial were used to evaluate the quality-adjusted life-years and direct health care costs (in United Kingdom 2017 prices) over a lifetime with TDR versus nurse-led support in adults who had obesity, assuming that (i) weight returns to baseline over 5 years and (ii) a 1-kg weight loss is maintained after 5 years following TDR. Results: The per-person costs of the TDR and nurse-led programs were £796 and £34, respectively. The incremental cost-effectiveness ratio of TDR was £12,955 (95% CI: £8,082-£17,827) assuming that all weight lost is regained and £3,203 (£2,580-£3,825) assuming that a 1-kg weight loss is maintained after 5 years. TDR was estimated to be more cost-effective (i.e., lower incremental cost-effectiveness ratios) in older adults and those with a higher BMI, with little difference by gender. Conclusions: At current retail prices and with plausible long-term weight regain trajectories, TDR is projected to be cost-effective in adults with obesity and could be considered as an option to treat obesity in routine health care settings.