Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial

Objective To assess the accuracy of general practitioners, practice nurses, and interpretative software in the use of different types of electrocardiogram to diagnose atrial fibrillation. Design Prospective comparison with reference standard of assessment of electrocardiograms by two independent specialists. Setting 49 general practices in central England. Participants 2595 patients aged 65 or over screened for atrial fibrillation as part of the screening for atrial fibrillation in the elderly (SAFE) study; 49 general practitioners and 49 practice nurses. Interventions All electrocardiograms were read with the Biolog interpretative software, and a random sample of 12 lead, limb lead, and single lead thoracic placement electrocardiograms were assessed by general practitioners and practice nurses independently of each other and of the Biolog assessment. Main outcome measures Sensitivity, specificity, and positive and negative predictive values. Results General practitioners detected 79 out of 99 cases of atrial fibrillation on a 12 lead electrocardiogram (sensitivity 80%, 95% confidence interval 71% to 87%) and misinterpreted 114 out of 1355 cases of sinus rhythm as atrial fibrillation (specificity 92%, 90% to 93%). Practice nurses detected a similar proportion of cases of atrial fibrillation (sensitivity 77%, 67% to 85%), but had a lower specificity (85%, 83% to 87%). The interpretative software was significantly more accurate, with a specificity of 99%, but missed 36 of 215 cases of atrial fibrillation (sensitivity 83%). Combining general practitioners' interpretation with the interpretative software led to a sensitivity of 92% and a specificity of 91%. Use of limb lead or single lead thoracic placement electrocardiograms resulted in some loss of specificity. Conclusions Many primary care professionals cannot accurately detect atrial fibrillation on an electrocardiogram, and interpretative software is not sufficiently accurate to circumvent this problem, even when combined with interpretation by a general practitioner. Diagnosis of atrial fibrillation in the community needs to factor in the reading of electrocardiograms by appropriately trained peopl

From breathless to failure:symptom onset and diagnostic meaning in patients with heart failure - a qualitative study

Objectives: To explore 2 key points in the heart failure diagnostic pathway-symptom onset and diagnostic meaning-from the patient perspective. Design: Qualitative interview study. Setting: Participants were recruited from a secondary care clinic in central England following referral from primary care. Participants: Over age 55 years with a recent (<1 year) diagnosis of heart failure confirmed by a cardiologist following initial presentation to primary care. Methods: Semistructured interviews were carried out with 16 participants (11 men and 5 women, median age 78.5 years) in their own homes. Data were audiorecorded and transcribed. Participants were asked to describe their diagnostic journey from when they first noticed something wrong up to and including the point of diagnosis. Data were analysed using the framework method. Results: Participants initially normalised symptoms and only sought medical help when daily activities were affected. Failure to realise that anything was wrong led to a delay in help-seeking. Participants' understanding of the term 'heart failure' was variable and 1 participant did not know he had the condition. The term itself caused great anxiety initially but participants learnt to cope with and accept their diagnosis over time. Conclusions: Greater public awareness of symptoms and adequate explanation of 'heart failure' as a diagnostic label, or reconsideration of its use, are potential areas of service improvement

Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: Screening versus routine practice in detection cluster randomised controlled trial

Objectives : To assess whether screening improves the detection of atrial fibrillation (cluster randomisation) and to compare systematic and opportunistic screening. Design : Multicentred cluster randomised controlled trial, with subsidiary trial embedded within the intervention arm. Setting : 50 primary care centres in England, with further individual randomisation of patients in the intervention practices. Participants : 14,802 patients aged 65 or over in 25 intervention and 25 control practices. Interventions : Patients in intervention practices were randomly allocated to systematic screening (invitation for electrocardiography) or opportunistic screening (pulse taking and invitation for electrocardiography if the pulse was irregular). Screening took place over 12 months in each practice from October 2001 to February 2003. No active screening took place in control practices. Main outcome measure : Newly identified atrial fibrillation. Results : The detection rate of new cases of atrial fibrillation was 1.63% a year in the intervention practices and 1.04% in control practices (difference 0.59%, 95% confidence interval 0.20% to 0.98%). Systematic and opportunistic screening detected similar numbers of new cases (1.62% v 1.64%, difference 0.02%, −0.5% to 0.5%). Conclusion : Active screening for atrial fibrillation detects additional cases over current practice. The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography. Trial registration Current Controlled Trials ISRCTN19633732

Impure placebo as an unsound concept and other problems in the paper by Howick et al. : [eLetter]

Kommentti artikkeliin Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners, Plos One 8(3):e58247. doi: 10.1371/journal.pone.0058247Howick et al. have reported the findings of a survey that addressed the use of placebos among primary care practitioners in the United Kingdom. They adopted methodology similar to that used in previous studies performed in other countries; however, the use of this approach also means that they repeated the conceptual confusion of the previous surveys. Therefore the findings are not useful. ... The paper’s main finding “placebos are commonly used in UK primary care” is not correct. Only 0.9% of the responding general practitioners reported using pure placebos frequently. The frequency with which impure placebos are used is irrelevant because the concept is useless, as described above. Misleading a patient by administering inert substances without the explicit consent of the patient is unethical. The authors' proposal to “develop ethical and cost-effective placebos” is not possible because saving money by misleading patients is unethical. There is substantial conceptual confusion in the area of placebo and placebo-effect research, and the paper by Howick et al. does not help to reduce this confusion.Non peer reviewe

Weight regain after behavioural weight management programmes and its impact on quality of life and cost effectiveness: evidence synthesis and health economic analyses

Aims We used data from a recent systematic review to investigate weight regain after behavioural weight management programmes (BWMPs, sometimes referred to as lifestyle modification programmes) and its impact on quality-of-life and cost-effectiveness. Materials and Methods Trial registries, databases and forward-citation searching (latest search December 2019) were used to identify randomized trials of BWMPs in adults with overweight/obesity reporting outcomes at ≥12 months, and after programme end. Two independent reviewers screened records. One reviewer extracted data and a second checked them. The differences between intervention and control groups were synthesized using mixed-effect, meta-regression and time-to-event models. We examined associations between weight difference and difference in quality-of-life. Cost-effectiveness was estimated from a health sector perspective. Results In total, 155 trials (n > 150 000) contributed to analyses. The longest follow-up was 23 years post-programme. At programme end, intervention groups achieved –2.8 kg (95%CI –3.2 to –2.4) greater weight loss than controls. Weight regain after programme end was 0.12-0.32 kg/year greater in intervention relative to control groups, with a between-group difference evident for at least 5 years. Quality-of-life increased in intervention groups relative to control at programme end and thereafter returned to control as the difference in weight between groups diminished. BWMPs with this initial weight loss and subsequent regain would be cost-effective if delivered for under £560 (£8.80-£3900) per person. Conclusions Modest rates of weight regain, with persistent benefits for several years, should encourage health care practitioners and policymakers to offer obesity treatments that cost less than our suggested thresholds as a cost-effective intervention to improve long-term weight management

Treatment of Cancer‐Associated Venous Thromboembolism: 12‐month outcomes of the placebo versus rivaroxaban randomisation of the SELECT‐D Trial. (SELECT‐D: 12m)

Background The SELECT‐D trial demonstrated reduction in recurrent venous thromboembolism (VTE) but increased bleeding with rivaroxaban compared to dalteparin for treatment of acute VTE in cancer patients, at 6 months. Uncertainty remains around optimal duration of anticoagulation. Objectives To assess VTE recurrence and bleeding, with anticoagulation or not, beyond 6 months Patients/Methods In SELECT‐D, after 6 months of trial treatment for VTE, patients with active cancer and residual deep vein thrombosis (RDVT) or index pulmonary embolism (PE) were eligible for randomisation to a further 6 months of rivaroxaban or placebo. Patients with no RDVT stopped anticoagulation. Primary outcome was VTE recurrence at 12 months. The second randomisation closed prematurely due to low recruitment when 92 of the planned 300 patients were recruited. Results 92 of 136 eligible patients were randomised to rivaroxaban or placebo. The cumulative VTE recurrence after 6 months from the second randomisation, was 14% with placebo and 4% with rivaroxaban (Hazard Ratio 0.32; 95% CI 0.06‐1.58). The major and clinically‐relevant non‐major bleeding rates were 0% and 0% with placebo; and 5% (95% CI 1‐18%) and 4% (95% CI 1‐17%) with rivaroxaban. In an exploratory analysis, 7 (15.2 %) of 46 placebo patients with RDVT or an index PE experienced recurrent VTE compared to none in the 35 patients in the RDVT‐negative cohort (P=0.03). Conclusion The SELECT‐D trial was underpowered to detect a statistically significant reduction in recurrent VTE with extended anticoagulation. The absence of RDVT and/or index PE, defined a population at low risk of recurrence

Randomized controlled trial of molnupiravir SARS-CoV-2 viral and antibody response in at-risk adult outpatients

Viral clearance, antibody response and the mutagenic effect of molnupiravir has not been elucidated in at-risk populations. Non-hospitalised participants within 5 days of SARS-CoV-2 symptoms randomised to receive molnupiravir (n = 253) or Usual Care (n = 324) were recruited to study viral and antibody dynamics and the effect of molnupiravir on viral whole genome sequence from 1437 viral genomes. Molnupiravir accelerates viral load decline, but virus is detectable by Day 5 in most cases. At Day 14 (9 days post-treatment), molnupiravir is associated with significantly higher viral persistence and significantly lower anti-SARS-CoV-2 spike antibody titres compared to Usual Care. Serial sequencing reveals increased mutagenesis with molnupiravir treatment. Persistence of detectable viral RNA at Day 14 in the molnupiravir group is associated with higher transition mutations following treatment cessation. Viral viability at Day 14 is similar in both groups with post-molnupiravir treated samples cultured up to 9 days post cessation of treatment. The current 5-day molnupiravir course is too short. Longer courses should be tested to reduce the risk of potentially transmissible molnupiravir-mutated variants being generated. Trial registration: ISRCTN3044803