Animation Supported Consent Before Elective Laparoscopic Cholecystectomy.

BACKGROUND: Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making. METHODS: Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery ( www.explainmyprocedure.com/lapchole ). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared. RESULTS: The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54, 57, 38 and 24% and in the animation group, 91, 91, 74 and 77%, respectively; p < 0.01 for each comparison. CONCLUSION: The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.

Child-Parent Familial Hypercholesterolemia Screening in Primary Care.

BACKGROUND: Child-parent screening for familial hypercholesterolemia has been proposed to identify persons at high risk for inherited premature cardiovascular disease. We assessed the efficacy and feasibility of such screening in primary care practice. METHODS: We obtained capillary blood samples to measure cholesterol levels and to test for familial hypercholesterolemia mutations in 10,095 children 1 to 2 years of age during routine immunization visits. Children were considered to have positive screening results for familial hypercholesterolemia if their cholesterol level was elevated and they had either a familial hypercholesterolemia mutation or a repeat elevated cholesterol level 3 months later. A parent of each child with a positive screening result for familial hypercholesterolemia was considered to have a positive screening result for familial hypercholesterolemia if he or she had the same mutation as the child or, if no mutations were identified, had the higher cholesterol level of the two parents. RESULTS: The use of a prespecified cholesterol cutoff value of 1.53 multiples of the median (MoM, corresponding to a percentile of 99.2) identified 28 children who had positive screening results for familial hypercholesterolemia (0.3% of the 10,095 children; 95% confidence interval [CI], 0.2 to 0.4), including 20 with a familial hypercholesterolemia mutation and 8 with a repeat cholesterol level of at least 1.53 MoM. A total of 17 children who had a cholesterol level of less than 1.53 MoM also had a familial hypercholesterolemia mutation. The overall mutation prevalence was 1 in 273 children (37 in 10,095; 95% CI, 1 in 198 to 1 in 388). The use of an initial cholesterol cutoff value of 1.35 MoM (95th percentile) plus a mutation, or two cholesterol values of at least 1.50 MoM (99th percentile), identified 40 children who had positive screening results for familial hypercholesterolemia (0.4% of the 10,095 children, including 32 children who had a familial hypercholesterolemia mutation and 8 who did not have the mutation) and 40 parents who had positive screening results for familial hypercholesterolemia. CONCLUSIONS: Child-parent screening was feasible in primary care practices at routine child immunization visits. For every 1000 children screened, 8 persons (4 children and 4 parents) were identified as having positive screening results for familial hypercholesterolemia and were consequently at high risk for cardiovascular disease. (Funded by the Medical Research Council.).

Randomized trial of preventive angioplasty in myocardial infarction.

BACKGROUND: In acute ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to treat the artery responsible for the infarct (infarct, or culprit, artery) improves prognosis. The value of PCI in noninfarct coronary arteries with major stenoses (preventive PCI) is unknown. METHODS: From 2008 through 2013, at five centers in the United Kingdom, we enrolled 465 patients with acute STEMI (including 3 patients with left bundle-branch block) who were undergoing infarct-artery PCI and randomly assigned them to either preventive PCI (234 patients) or no preventive PCI (231 patients). Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia. The primary outcome was a composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. An intention-to-treat analysis was used. RESULTS: By January 2013, the results were considered conclusive by the data and safety monitoring committee, which recommended that the trial be stopped early. During a mean follow-up of 23 months, the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI (infarct-artery-only PCI), which translated into rates of 9 events per 100 patients and 23 per 100, respectively (hazard ratio in the preventive-PCI group, 0.35; 95% confidence interval [CI], 0.21 to 0.58; P<0.001). Hazard ratios for the three components of the primary outcome were 0.34 (95% CI, 0.11 to 1.08) for death from cardiac causes, 0.32 (95% CI, 0.13 to 0.75) for nonfatal myocardial infarction, and 0.35 (95% CI, 0.18 to 0.69) for refractory angina. CONCLUSIONS: In patients with STEMI and multivessel coronary artery disease undergoing infarct-artery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery. (Funded by Barts and the London Charity; PRAMI Current Controlled Trials number, ISRCTN73028481.).

The evaluation of cascade testing for familial hypercholesterolemia.

Familial hypercholesterolemia (FH) is an autosomal dominant disorder with a high risk of coronary heart disease at a young age that can be reduced by cholesterol-lowering drugs. Computer simulation was used to estimate the screening performance of three strategies of cascade testing for FH (a process of searching for relatives with FH once an individual is diagnosed with FH): (i) testing parents, siblings, and children (1st degree relatives) of an FH index case, (ii) testing (i) and testing 1st degree relatives of subsequently identified relatives with FH, and (iii) testing (ii) and also testing aunts, uncles, nephews, nieces, grandparents, and first cousins (2nd or 3rd degree relatives) when 1st degree relatives of an individual with FH are not available. For cascade testing to achieve detection rates of 80%, (i) 25%, (ii) 11%, and (iii) 8% of FH index cases who are unrelated need to be identified. To identify these unrelated FH index cases, (i) 45% (ii) 23%, and (iii) 17% of all individuals with FH need to be identified independently of cascade testing. Cascade testing is not a suitable method of population screening for FH, because a separate method of systematically identifying new FH index cases is required to achieve a reasonable level of FH detection in the population. Such an alternative systematic method of identifying new cases could itself be the method of population screening.

Animation supported communication on intensive care; a service improvement initiative.

Objective: COVID-19 has created unique challenges for families of patients admitted to intensive care units. Restricted visiting, language barriers and time constraints have limited communication, resulting in a lack of understanding and anxiety. We introduced digital animations to support communication and assessed the impact on families of patients admitted to intensive care. Methods: Multi-language animations explaining mechanical ventilation, (www.explainmyprocedure.com/icu) were introduced at two London intensive care units during the COVID-19 pandemic. Web-links were sent by email. Reported understanding of the treatment, its benefits, risks and alternatives was assessed among family contacts of 71 consecutive patients admitted to intensive care; 39 before the animations were introduced (no animation group) and 32 afterwards (animation group). Reported understanding in the two groups was assessed by telephone questionnaire and compared. Results: Following introduction, all relatives reported they had watched the animation. The proportions who reported complete understanding of mechanical ventilation, its benefits, risks and alternatives, in the no animation group (n = 39) were, respectively, 15%, 28%, 0% and 3% and in the animation group (n = 32), 94%, 97%, 84% and 66% (p < 0.0001 for all comparisons). Conclusion: Family use of online multi-language animations explaining mechanical ventilation is feasible, acceptable and associated with substantial improvement in understanding. The approach is not limited to mechanical ventilation, or to use in a pandemic, and has the potential to be applied to a wide range of treatment and recovery pathways on intensive care.

Child-parent screening for familial hypercholesterolemia.

A pilot study of child-parent screening for familial hypercholesterolemia was undertaken in children aged 1 to 2 years coming for immunization. Of 214 parents asked, 200 agreed to screening (94%). Simultaneous immunization-cholesterol measurement was successful in all children. Population child-parent screening is feasible and acceptable when combined with pediatric immunization.

Serum homocysteine and dementia: meta-analysis of eight cohort studies including 8669 participants.

BACKGROUND: Prospective cohort studies have not been consistent in showing an association between serum homocysteine and dementia. OBJECTIVE: To conduct a meta-analysis of cohort studies that examined the relationship between serum homocysteine and dementia, and to estimate the change in risk of dementia for a unit change in serum homocysteine. METHODS: The data from eight cohort studies (involving 8,669 participants; range of mean ages, 47-81 years; median duration of study, 5 years) of serum homocysteine on the incidence of dementia were combined and the odds ratio of dementia per 5 µmol/L increase in serum homocysteine was determined. RESULTS: There was a statistically significant association between serum homocysteine and the incidence of dementia: the odds ratio for a 5 µmol/L increase in serum homocysteine was 1.35 (95% confidence interval, 1.02-1.79) or 1.50 (1.13-2.00) adjusted for regression dilution bias. The odds ratio for a 3 µmol/L decrease in serum homocysteine (the average reduction expected using folic acid and B12) was 0.78 (0.66-0.93). CONCLUSION: The meta-analysis of epidemiological cohort studies shows a positive association between serum homocysteine and dementia. Although the results do not provide evidence of cause and effect, they do provide an estimate of the expected effect if the relationship were causal; an approximate 20% reduction in risk of dementia from treatment with folic acid and B12.

Potential impact of gradual reduction of fat content in manufactured and out-of-home food on obesity in the United Kingdom: a modeling study.

BACKGROUND: Manufactured and out-of-home foods contribute to excessive calories and have a critical role in fueling the obesity epidemic. We propose a 20% fat reduction in these foods. OBJECTIVES: To evaluate the potential impact of the proposed strategy on energy intake, obesity and related health outcomes in the population. METHODS: We used the National Diet and Nutrition Survey rolling program (NDNS RP) data to calculate fat and energy contributions from 46 manufactured and out-of-home food categories. We considered a gradual fat reduction-focusing on SFA-in these categories to achieve a 20% reduction in 5 years. We estimated the reduction in energy intake in the NDNS RP population and predicted the body weight reduction using a weight loss model. We scaled up the body weight reduction to the UK adult population. We estimated reductions in overweight/obesity and type 2 diabetes cases. We calculated the reductions of LDL, ischemic heart disease (IHD), and stroke deaths that could be prevented from the SFA reduction. RESULTS: The selected categories contributed to 38.6% of the population's energy intake. By the end of the fifth year, our proposed strategy would reduce the mean energy intake by 67.6 kcal/d/person (95% CI: 66.1-68.8). The energy reduction would reduce the mean body weight by 2.7 kg (95% CI: 2.6-2.8). The obesity prevalence would be reduced by 5.3% and the overweight prevalence by 1.5%, corresponding to 3.5 and 1 million cases of obesity and overweight, respectively, being reduced in the United Kingdom. The body weight reduction could prevent 183,000 (95% CI: 171,000-194,000) cases of type 2 diabetes over 2 decades. Energy from SFA would fall by 2.6%, lowering LDL by 0.13 mmol/L and preventing 87,560 IHD deaths (95% CI: 82,260-112,760) and 9520 stroke deaths (95% CI: 4400-14,660) over 20 years. CONCLUSIONS: A modest fat reduction (particularly in SFA) in widely consumed foods would prevent obesity, type 2 diabetes, and cardiovascular disease.

Reaching detection targets in familial hypercholesterolaemia: Comparison of identification strategies.

BACKGROUND AND AIMS: Familial hypercholesterolaemia (FH) is a common and preventable cause of premature heart attack but in most nations only a small proportion of FH-positive individuals have been identified. The aim of this study was to estimate the time to close this FH detection gap. METHODS: We developed a model to estimate the time to identify different proportions of FH in the population for three identification strategies (i) Cascade Testing (FH-mutation testing in relatives of someone with an FH mutation) (ii) Child-parent Screening (testing children for cholesterol and FH mutations during 1-year immunisation and parents of FH-positive children) and (iii) Child-parent Cascade Screening (integrating the first two methods). We used publicly available data to compare the strategies in terms of the time to identify 25%, 50% and 75% of all FH cases in the UK (current target is 25% in 5 years). For Child-parent Cascade Screening, we applied the model to other populations that have reported FH identification levels. RESULTS: In the UK, 25% of FH individuals would be identified after 47 years for Cascade Testing, 12 years for Child-parent Screening and 8 years for Child-parent Cascade Screening; 50% identification after 146, 33 and 19 years and 75% after 334, 99 and 41 years respectively. For Child-parent Cascade Screening, the times to identify 50% FH were, for Netherlands, Norway, Japan, Canada, USA, Australia/NZ, South Africa and Russia, 0, 5, 13, 15, 16, 18, 21, and 30 years respectively. CONCLUSIONS: Child-parent Cascade Screening is the fastest strategy for identifying FH in the population. The model is applicable to any country to estimate the time to close the FH detection gap (www.screenfh.com).

Should fractional flow reserve follow angiographic visual inspection to guide preventive percutaneous coronary intervention in ST-elevation myocardial infarction?

AIMS: We aimed to quantify the effect of preventive percutaneous coronary intervention (PCI to non-infarct arteries) on cardiac death and non-fatal myocardial infarction (MI) in patients with ST-elevation myocardial infarction (STEMI) according to whether the decision to carry out preventive PCI was based on angiographic visual inspection (AVI alone) or AVI plus fractional flow reserve (FFR) if AVI showed significant stenosis (AVI plus FFR). METHODS AND RESULTS: Randomized trials comparing preventive PCI with no preventive PCI in STEMI without shock were identified by a systematic literature search and categorized according to whether they used AVI alone or AVI plus FFR to select patients for preventive PCI. Random effects meta-analyses and tests of heterogeneity were used to compare the two categories in respect of cardiac death and MI as a combined outcome and individually. Eleven eligible trials were identified. For cardiac death and MI, the relative risk estimates for AVI alone vs. AVI plus FFR were 0.39 (0.25-0.61) and 0.85 (0.57-1.28), respectively (P = 0.01 for difference), for cardiac death, alone the estimates were 0.36 (0.19-0.71) and 0.79 (0.36-1.77), respectively (P = 0.15 for difference), and for MI alone, 0.41 (0.23-0.73) and 0.98 (0.62-1.56), respectively (P = 0.04 for difference). CONCLUSION: In preventive PCI among STEMI patients, AVI alone achieves a ∼60% reduction in cardiac death and MI but selecting patients using FFR in AVI positive patients loses much of the benefit. Angiographic visual inspection is best used without FFR in this group of patients.

Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative.

OBJECTIVE: Patient understanding of angiography and angioplasty is often incomplete at the time of consent. Language barriers and time constraints are significant obstacles, particularly in the urgent setting. We introduced digital animations to support consent and assessed the effect on patient understanding. METHODS: Multi-language animations explaining angiography and angioplasty (www.explainmyprocedure.com/heart) were introduced at nine district hospitals for patients with acute coronary syndrome before urgent transfer to a cardiac centre for their procedure. Reported understanding of the reason for transfer, the procedure, its benefits and risks in 100 consecutive patients were recorded before introduction of the animations into practice (no animation group) and in 100 consecutive patients after their introduction (animation group). Patient understanding in the two groups was compared. RESULTS: Following introduction, 83/100 patients reported they had watched the animation before inter-hospital transfer (3 declined and 14 were overlooked). The proportions of patients who understood the reason for transfer, the procedure, its benefits and risks in the no animation group were 58%, 38%, 25% and 7% and in the animation group, 85%, 81%, 73% and 61%, respectively. The relative improvement (ratio of proportions) was 1.5 (95% CI 1.2 to 1.8), 2.1 (1.6 to 2.8), 2.9 (2.0 to 4.2) and 8.7 (4.2 to 18.1), respectively (p<0.001 for all comparisons). CONCLUSION: Use of animations explaining angiography and angioplasty is feasible before urgent inter-hospital transfer and was associated with substantial improvement in reported understanding of the procedure, its risks and its benefits. The approach is not limited to cardiology and has the potential to be applied to all specialties in medicine.

Integration of child-parent screening and cascade testing for familial hypercholesterolaemia.

OBJECTIVE: To integrate child-parent screening and cascade testing into a single pathway-child-parent cascade screening (CPCS), for the identification of familial hypercholesterolaemia in the population and to estimate the number of new familial hypercholesterolaemia cases identified per child screened and the associated costs. METHODS: We applied the results from the published MRC Child-Parent Screening Study to 10,000 children, together with cascade testing first degree relatives of parents with a familial hypercholesterolaemia mutation identified by child-parent screening. We estimated the number of familial hypercholesterolaemia cases identified per child screened, the median cost per familial hypercholesterolaemia case identified and the median cost per child screened to identify one case using a range of cholesterol and familial hypercholesterolaemia mutation testing costs. We present a case study to illustrate the application of CPCS in practice. RESULTS: CPCS identifies one new familial hypercholesterolaemia case per 70 children screened at a median estimated cost of £960 per new familial hypercholesterolaemia case or £4 per child screened. CPCS identifies an average of four new familial hypercholesterolaemia cases per family. In the case study, six new familial hypercholesterolaemia cases were identified, and preventive treatment started in five, with the index child expected to start when older. CONCLUSION: CPCS for familial hypercholesterolaemia are complementary strategies. The sustainability of cascade testing relies on identifying new unrelated index cases. This is achieved with population-wide child-parent screening. Integrated CPCS is currently better than either method of familial hypercholesterolaemia detection alone. It has the potential to identify all, or nearly all, individuals with familial hypercholesterolaemia in the population at low cost.

Randomized Crossover Trial of Phosphate-binding Medication on Serum Phosphate Levels in Patients With Aortic Stenosis.

PURPOSE: Aortic stenosis is a common cause of valvular heart disease with no means of prevention. The recognized association between aortic stenosis and serum phosphate raises the possibility of preventing progression of the disorder by using phosphate-binding drugs, but there is uncertainty whether such treatment lowers serum phosphate levels in patients without diagnosed renal failure. This pilot study was conducted to answer this question in patients with aortic stenosis. METHODS: A randomized, double-blind, crossover trial of the phosphate-binding drug sevelamer was conducted in 72 patients. Patients were prescribed sevelamer 0.8 g (low-dose), sevelamer 2.4 g (high-dose), and matching placebo, 3 times daily with food; each regimen lasted 6 weeks and was allocated at random. Serum phosphate levels were measured at the end of each treatment period, and within-person levels were compared. FINDINGS: Sixty-one patients completed the 3 treatment periods. There was no significant difference in the mean end-treatment phosphate levels across all patients (3.38, 3.36, and 3.31 mg/dL with placebo, low-dose sevelamer, and high-dose sevelamer, respectively). Post hoc analysis showed a reduction in phosphate levels with increasing sevelamer dose in the highest baseline phosphate quartile group; a 0.3 mg/dL reduction (mean, 4.09 mg/dL with placebo, 3.95 mg/dL with low-dose sevelamer, and 3.79 mg/dL with high-dose sevelamer; Ptrend = 0.027). IMPLICATIONS: Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution. This hypothesis-generating result requires confirmation in an independent study. If confirmed, a trial of sevelamer in preventing the progression of aortic stenosis may be justified in patients with high phosphate levels. ISRCTN Registry identifier: ISRCTN17365679.

Current management of children and young people with heterozygous familial hypercholesterolaemia - HEART UK statement of care.

This consensus statement on the management of children and young people with heterozygous familial hypercholesterolaemia (FH) addresses management of paediatric FH in the UK, identified by cascade testing when a parent is diagnosed with FH and for those diagnosed following incidental lipid tests. Lifestyle and dietary advice appropriate for children with FH; suggested low density lipoprotein cholesterol (LDL-C) targets and the most appropriate lipid-lowering therapies to achieve these are discussed in this statement of care. Based on the population prevalence of FH as ~1/250 and the UK paediatric population, there are approximately 50,000 FH children under 18 years. Currently only about 550 of these children and young people have been identified and are under paediatric care.

A 16-week, randomized, double-blind, placebo-controlled, crossover trial to quantify the combined effect of an angiotensin-converting enzyme inhibitor and a beta-blocker on blood pressure reduction.

BACKGROUND: Although beta-blockers and angiotensin-converting enzyme (ACE) inhibitors are often used together, there is a lack of quantitative evidence for the efficacy of this combination in reducing blood pressure (BP). OBJECTIVE: The aim of this randomized, double-blind, placebo-controlled, crossover study was to quantify the combined effect of a beta-blocker (atenolol) and an ACE inhibitor (lisinopril) in lowering BP. METHODS: Participants who were > or = 40 years of age and enrolled in the hypertension or anticoagulation clinics at St. Bartholomew's Hospital, London, United Kingdom, were randomized to 3 consecutive 4-week treatments consisting of atenolol 25 mg plus placebo, lisinopril 5 mg plus placebo, and atenolol 25 mg plus lisinopril 5 mg, plus a period of 2 placebos. At the end of each period, seated BP was measured in the right arm using electronic monitors. RESULTS: The mean placebo-adjusted peak BP reductions among the 47 participants (mean age, 62 [range 42-82] years; 75% male; 70% white/30% Asian; mean baseline BP, 145/82 mm Hg) who completed all 4 periods were significantly greater with the combination of both drugs than with either drug alone (P < 0.001). The systolic reductions were 22.9 mm Hg with combination treatment, 16.1 mm Hg with atenolol treatment, and 12.5 mm Hg with lisinopril treatment, and the diastolic reductions were 13.9, 9.8, and 6.8 mm Hg, respectively. The BP-lowering effect of the 2 drugs together was similar to that expected from the sum of each alone, allowing for the reduced effect of 1 drug given the lower pretreatment BP due to the other. The incremental systolic BP reduction from the 2 drugs together compared with 1 alone was 79% (95% CI, 54%-126%) of the expected additive effect, 88% (95% CI, 58%-130%) for diastolic BP, and 84% (95% CI, 65%-118%) for the mean of systolic and diastolic BP. CONCLUSIONS: The combination of the beta-blocker atenolol 25 mg plus the ACE inhibitor lisinopril 5 mg was associated with a significantly greater decrease in BP compared with either alone. The BP reduction with the combination treatment was similar to and statistically consistent with the 2 drugs having additive effects. Clinical Trials Identification Number: ISRCTN97280940.