Effects of the COVID-19 pandemic on secondary care for cardiovascular disease in the UK: an electronic health record analysis across three countries.

BACKGROUND: Although morbidity and mortality from COVID-19 have been widely reported, the indirect effects of the pandemic beyond 2020 on other major diseases and health service activity have not been well described. METHODS AND RESULTS: Analyses used national administrative electronic hospital records in England, Scotland, and Wales for 2016-21. Admissions and procedures during the pandemic (2020-21) related to six major cardiovascular conditions [acute coronary syndrome (ACS), heart failure (HF), stroke/transient ischaemic attack (TIA), peripheral arterial disease (PAD), aortic aneurysm (AA), and venous thromboembolism(VTE)] were compared with the annual average in the pre-pandemic period (2016-19). Differences were assessed by time period and urgency of care.In 2020, there were 31 064 (-6%) fewer hospital admissions [14 506 (-4%) fewer emergencies, 16 560 (-23%) fewer elective admissions] compared with 2016-19 for the six major cardiovascular diseases (CVDs) combined. The proportional reduction in admissions was similar in all three countries. Overall, hospital admissions returned to pre-pandemic levels in 2021. Elective admissions remained substantially below expected levels for almost all conditions in all three countries [-10 996 (-15%) fewer admissions]. However, these reductions were offset by higher than expected total emergency admissions [+25 878 (+6%) higher admissions], notably for HF and stroke in England, and for VTE in all three countries. Analyses for procedures showed similar temporal variations to admissions. CONCLUSION: The present study highlights increasing emergency cardiovascular admissions during the pandemic, in the context of a substantial and sustained reduction in elective admissions and procedures. This is likely to increase further the demands on cardiovascular services over the coming years.

Interventions to improve district-level routine health data in low-income and middle-income countries: a systematic review.

BACKGROUND: Routine health information system(s) (RHIS) facilitate the collection of health data at all levels of the health system allowing estimates of disease prevalence, treatment and preventive intervention coverage, and risk factors to guide disease control strategies. This core health system pillar remains underdeveloped in many low-income and middle-income countries. Efforts to improve RHIS data coverage, quality and timeliness were launched over 10 years ago. METHODS: A systematic review was performed across 12 databases and literature search engines for both peer-reviewed articles and grey literature reports on RHIS interventions. Studies were analysed in three stages: (1) categorisation of RHIS intervention components and processes; (2) comparison of intervention component effectiveness and (3) whether the post-intervention outcome improved above the WHO integrated disease surveillance response framework data quality standard of 80% or above. RESULTS: 5294 references were screened, resulting in 56 studies. Three key performance determinants-technical, organisational and behavioural-were proposed as critical to RHIS strengthening. Seventy-seven per cent [77%] of studies identified addressed all three determinants. The most frequently implemented intervention components were 'providing training' and 'using an electronic health management information systems'. Ninety-three per cent [93%] of pre-post or controlled trial studies showed improvements in one or more data quality outputs, but after applying a standard threshold of >80% post-intervention, this number reduced to 68%. There was an observed benefit of multi-component interventions that either conducted data quality training or that addressed improvement across multiple processes and determinants of RHIS. CONCLUSION: Holistic data quality interventions that address multiple determinants should be continuously practised for strengthening RHIS. Studies with clearly defined and pragmatic outcomes are required for future RHIS improvement interventions. These should be accompanied by qualitative studies and cost analyses to understand which investments are needed to sustain high-quality RHIS in low-income and middle-income countries.

The assessment of a manikin-based low-dose, high-frequency cardiac resuscitation quality improvement program in early UK adopter hospitals.

BACKGROUND: Adult and paediatric basic life support (BLS) training are often conducted via group training with an accredited instructor every 24 months. Multiple studies have demonstrated a decline in the quality of cardio-pulmonary resuscitation (CPR) performed as soon as 3-month post-training. The 'Resuscitation Quality Improvement' (RQI) programme is a quarterly low-dose, high-frequency training, based around the use of manikins connected to a cart providing real-time and summative feedback. We aimed to evaluate the effects of the RQI Programme on CPR psychomotor skills in UK hospitals that had adopted this as a method of BLS training, and establish whether this program leads to increased compliance in CPR training. METHODS: The study took place across three adopter sites and one control site. Participants completed a baseline assessment without live feedback. Following this, participants at the adopter sites followed the RQI curriculum for adult CPR, or adult and infant CPR. The curriculum was split into quarterly training blocks, and live feedback was given on technique during the training session via the RQI cart. After following the curriculum for 12/24 months, participants completed a second assessment without live feedback. RESULTS: At the adopter sites, there was a significant improvement in the overall score between baseline and assessment for infant ventilations (N = 167, p < 0.001), adult ventilations (n = 129, p < 0.001), infant compressions (n = 163, p < 0.001) adult compressions (n = 205, p < 0.001), and adult CPR (n = 249, p < 0.001). There was no significant improvement in the overall score for infant CPR (n = 206, p = 0.08). Data from the control site demonstrated a statistically significant improvement in mean score for adult CPR (n = 22, p = 0.02), but not for adult compressions (N = 18, p = 0.39) or ventilations (n = 17, p = 0.08). No statistically significant difference in improvement of mean scores was found between the grouped adopter sites and the control site. The effect of the duration of the RQI curriculum on CPR performance appeared to be minimal in this data set. Compliance with the RQI curriculum varied by site, one site maintained hospital compliance at 90% over a 1 year period, however compliance reduced over time at all sites. CONCLUSIONS: This data demonstrated an increased adherence with guidelines for high-quality CPR post-training with the RQI cart, for all adult and most infant measures, but not infant CPR. However, the relationship between a formalised quarterly RQI curriculum and improvements in resuscitation skills is not clear. It is also unclear whether the RQI approach is superior to the current classroom-based BLS training for CPR skill acquisition in the UK. Further research is required to establish how to optimally implement the RQI system in the UK and how to optimally improve hospital wide compliance with CPR training to improve the outcomes of in-hospital cardiac arrests.

SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.

Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King's Technology Evaluation Centre, an External Assessment Centre commissioned by the National Institute for Health and Care Excellence, independently critiqued the manufacturer's submissions. The External Assessment Centre found a lack of evidence comparing SecurAcath with alternative approaches to securement (StatLock, suturing, tape securement), with one unpublished randomised controlled trial providing the strongest evidence. The External Assessment Centre conducted a new systematic review and meta-analysis and concluded that there is some evidence indicating the non-inferiority of SecurAcath compared to StatLock. The External Assessment Centre considered the manufacturer's economic model to be appropriate but made revisions to some parameters and noted significant heterogeneity in the included studies. The revised model indicated that StatLock was more cost effective than SecurAcath for catheter indwell times of up to 5 days; however, for medium- and long-term indwell times, SecurAcath was the most cost-effective option. The National Institute for Health and Care Excellence Medical Technologies Guidance MTG 34, issued in June 2017, recommended the adoption of SecurAcath for securing peripherally inserted central catheters within the National Health Service in England.

Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: Protocol for a Prospective, Multicenter Study.

BACKGROUND: In the United Kingdom, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5%-10% who require further treatment. If cancer cannot be ruled out clinically and on the basis of biopsy results, the lesion is surgically removed. One type of precancerous mole, called lentigo maligna, is particularly challenging to delineate and treat. Reflectance confocal microscopy (VivaScope, Caliber Imaging & Diagnostics) is an imaging technique that can supplement dermoscopy in identifying whether a clinically suspicious mole is malignant and can better assess lentigo maligna margins for excision. It allows clinicians to visualize the skin lesion to a depth of 200 microns with subcellular resolution, described as quasi-histological, and therefore better guide more accurate diagnoses. OBJECTIVE: The aim of this paper is to describe a prospective, single blinded, multicenter study to examine patients with clinically suspicious moles or lentigo maligna to determine whether confocal microscopy can both reduce the number of unnecessary biopsies of moles and more accurately guide the surgical excision margins of lentigo maligna. METHODS: This study will prospectively recruit adults into the following two cohorts: diagnostic accuracy and margin delineation. The diagnostic accuracy cohort will assess people with clinically suspicious lesions suspected of being diagnosed with melanoma and having an equivocal finding on dermoscopy or persistent clinical suspicion despite normal dermoscopy. Diagnostic accuracy will include the sensitivity and specificity of VivaScope in comparison with the histological diagnosis as the gold standard for patients. The margin delineation cohort will assess the ability of VivaScope to accurately delineate the margins of lentigo maligna compared with that of dermoscopy alone using margins taken during Mohs micrographic surgery as the gold standard. The primary study outcomes will be the diagnostic accuracy of VivaScope for the first cohort of patients and margin agreement between VivaScope and the final pathology report for the second cohort of patients. RESULTS: Funding for this proposed research is being secured. CONCLUSIONS: The outcomes of the proposed study will indicate how many biopsies of nonmelanoma lesions, which are potentially unnecessary, could be prevented. This would reduce patient anxiety and cost to the National Health Service (NHS) in the United Kingdom. Improved margin delineation of lentigo maligna could also improve the surgical clearance rates and decrease overall cost. The results would demonstrate whether the adoption of VivaScope would potentially benefit patients and the NHS. REGISTERED REPORT IDENTIFIER: RR1-10.2196/9296.

Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices.

Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.

Diagnostic delay and survival in high-grade gliomas - evidence of the 'waiting time paradox'?

INTRODUCTION: We present a retrospective single-centre study to determine whether delays in diagnosis of high-grade glioma (HGG) impact on overall survival (OS). MATERIAL AND METHODS: Consecutive patients diagnosed with HGG at a single neuroscience centre in 2011 were reviewed. Route of referral and time from initial presentation to diagnosis were analysed and correlated with OS. RESULTS: 118 patients were studied - 92 patients with glioblastoma (GBM). Diagnosis of GBM in patients presenting to emergency services was quicker than that through outpatients (8 days vs. 26 days, p < 0.0001), but these patients had significantly worse OS (181 days vs. 386 days p = 0.0075). This trend was observed for the whole cohort (Grade III and GBM), with OS 278 days in patients presenting to emergency services compared with 423 days for patients presenting via outpatients (p = 0.0034). Patients presenting to outpatients were younger (median age: 54 years) compared with patients presenting to emergency services (median age: 62.5 years) (p = 0.0106). There were no other differences between the two groups with respect to the nature of presenting symptoms. CONCLUSION: Earlier diagnosis is paradoxically associated with a worse OS in GBM. An 'aggressive' phenotype with rapid symptomatic deterioration and hence emergency presentation is a poor prognostic factor not influenced by earlier diagnosis.

Sex differences in device therapy for heart failure: utilization, outcomes, and adverse events.

BACKGROUND: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. METHODS: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. RESULTS: Ninety percent of the studies evaluated included ≤ 35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. CONCLUSIONS: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex.

Enrollment and monitoring of women in post-approval studies for medical devices mandated by the Food and Drug Administration.

BACKGROUND: Disease presentation, prevalence, and treatment effects vary by sex, thus it is important to ensure adequate participation of both sexes in medical device post-approval studies (PAS). METHODS: The goals of this study were to determine the participation rate of women in PAS mandated by the Food and Drug Administration (FDA) and if participation varied by clinical area. The study also evaluated the frequency in which enrollment by sex is reported by applicant reports and FDA reviews, as well as the frequency in which final study reports analyze whether outcomes differ by sex. RESULTS: Of 89 studies with enrollment completed, data on sex of participants were available in 93% of submitted reports, while data on enrollment by sex was evaluated and noted in 43% of FDA review memos. Study participation varied by clinical area, with female participation ranging from 32% in cardiovascular PAS to 90% in PAS for reconstructive devices. Of 53 completed studies, data on enrollment by sex was provided in 49 of the final reports. Of these 14% included a multivariate analysis that included sex as a covariate and 4% included a subgroup analysis for female participants. CONCLUSIONS: Data on sex was not routinely assessed in FDA reviews. Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews. FDA will continue working with applicants to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat.

Left bundle branch block predicts better survival in women than men receiving cardiac resynchronization therapy: long-term follow-up of ∼ 145,000 patients.

OBJECTIVES: The goal of this study was to test the hypothesis that in recipients of cardiac resynchronization therapy defibrillators (CRT-D), conventional left bundle branch block (LBBB) diagnosis predicts better survival in women than in men. BACKGROUND: New York Heart Association class I and II patients without LBBB do not benefit from CRT-D, and women have better survival after CRT-D than men. Separate analysis suggests that QRS duration thresholds for LBBB diagnosis differ according to sex, and conventional LBBB electrocardiographic criteria are falsely positive in men more frequently than in women. METHODS: We analyzed Medicare records from 144,642 CRT-D recipients between 2002 and 2008 that were followed up for up to 90 months. Medicare billing data were used to determine age, sex, race, and comorbidities. Hazard ratios (HRs) were calculated to assess if conventional LBBB diagnosis had different prognostic significance according to sex. RESULTS: In univariate analysis, LBBB was associated with a 31% reduction in death in women (HR: 0.69 [95% confidence interval (CI): 0.67 to 0.71]) but only a 16% reduction in death in men (HR: 0.84 [95% CI: 0.82 to 0.85]). In multivariable analyses controlling for comorbidities, LBBB was associated with a 26% reduction in death in women (HR: 0.74 [95% CI: 0.71 to 0.77]) and a 15% reduction in death in men (HR: 0.85 [95% CI: 0.83 to 0.87]). A significant interaction (p < 0.0001) between sex and LBBB was seen. CONCLUSIONS: LBBB diagnosis is associated with greater survival in women than in men receiving CRT-D, and this discrepancy is not explained by differences in measured comorbidities. Possible explanations for this difference include that LBBB may have different prognostic significance according to sex or that LBBB diagnosis is more often false-positive in men compared with women.

Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System.

BACKGROUND: The Food and Drug Administration (FDA) became aware of lead fracture and inappropriate shock events related to Sprint Fidelis leads in January 2007. The manufacturer announced a voluntary market withdrawal in October 2007. AIM: Our aim was to retrospectively evaluate this safety signal using disproportionality analysis to estimate whether disproportionality analysis could have detected this particular safety signal earlier than actually occurred. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database contains reports on device-related adverse events, of which, FDA receives several hundred thousand every year. For each manufacturer, a list of the top lead brand names was ranked by frequency of reports. We used the Multi-item Gamma Poisson Shrinker (MGPS) method for analysis. We isolated 11 top-reported implantable cardioverter defibrillator (ICD) lead brand names. Using MGPS methodology, we calculated the one-sided 95% lower confidence bound EB05 on the empirical Bayes geometric mean of the reporting ratio. RESULTS: We performed individual MGPS analysis for each of the top reported adverse events in 2006 for ICD leads. Fidelis had the highest EB05 scores for lead fractures and inappropriate shock. DISCUSSION: Through disproportionality analysis of the MAUDE database, we were able to identify known safety signals associated with the Medtronic Sprint Fidelis lead. CONCLUSION: If utilized at the time, this disproportionality analysis would have identified signals earlier for lead fractures, oversensing, high impedance, and inappropriate shock.