Kidney biopsy diagnosis in childhood in the Norwegian Kidney Biopsy Registry and the long-term risk of kidney replacement therapy: a 25-year follow-up.

BACKGROUND: There is scarce information on biopsy-verified kidney disease in childhood and its progression to chronic kidney disease stage 5 (CKD 5). This study aims to review biopsy findings in children, and to investigate risk of kidney replacement therapy (KRT). METHODS: We conducted a retrospective long-term follow-up study of children included in the Norwegian Kidney Biopsy Registry (NKBR) and in the Norwegian Renal Registry (NRR) from 1988 to 2021. RESULTS: In total, 575 children with a median (interquartile range, IQR) age of 10.7 (6.1 to 14.1) years were included, and median follow-up time (IQR) after kidney biopsy was 14.3 (range 8.9 to 21.6) years. The most common biopsy diagnoses were minimal change disease (MCD; n = 92), IgA vasculitis nephritis (IgAVN; n = 76), IgA nephropathy (n = 63), and focal and segmental glomerulosclerosis (FSGS; n = 47). In total, 118 (20.5%) of the biopsied children reached CKD 5, median (IQR) time to KRT 2.3 years (7 months to 8.4 years). Most frequently, nephronophthisis (NPHP; n = 16), FSGS (n = 30), IgA nephropathy (n = 9), and membranoproliferative glomerulonephritis (MPGN; n = 9) led to KRT. CONCLUSIONS: The risk of KRT after a kidney biopsy diagnosis is highly dependent on the diagnosis. None of the children with MCD commenced KRT, while 63.8% with FSGS and 100% with NPHP reached KRT. Combining data from kidney biopsy registries with registries on KRT allows for detailed information concerning the risk for later CKD 5 after biopsy-verified kidney disease in childhood. A higher resolution version of the Graphical abstract is available as Supplementary information.

Pain and analgesics in patients with hard-to-heal ulcers: using telemedicine or standard consultations.

OBJECTIVE: To compare consultations carried out via video with those performed in person for patients with painful, hard-to-heal ulcers, with a focus on ulcer pain and pain treatment. A further aim was to investigate predictors for pain and pain treatment. METHOD: This was a register-based, quasi-experimental study based on data from the Swedish Registry of Ulcer Treatment (RUT). A total of 100 patients with hard-to-heal ulcers diagnosed via video consultation were compared with 1888 patients diagnosed in person with regard to pain assessment, intensity and treatment. Ulcer pain intensity was assessed by the visual analogue scale (VAS). Normally distributed variables (age, VAS) were compared between consultation groups using Student's t-test. Non-normally distributed variables (ulcer size, ulcer duration) were compared using the Mann-Whitney U-test, except for healing time, which was analysed with a log-rank test. Categorical variables (gender, ulcer aetiology and prescribed analgesics) were compared using Pearson's chi-square test (χ2). A p value of less than 0.05 was considered to indicate statistical significance. Predictors for pain and pain treatment were analysed in multiple regression analyses. RESULTS: The results showed a high presence of pain; 71% of patients with pain reported severe ulcer pain. There was no significant difference in ability to assess pain by VAS in the group diagnosed via video consultation (90%) compared with the group diagnosed in person (86%) (χ2, p=0.233). A significantly higher amount of prescribed analgesics was found for patients diagnosed via video (84%) compared with patients diagnosed by in-person assessment (68%) (χ2, p=0.044). Predictors for high-intensity pain were female gender or ulcers due to inflammatory vessel disease, while the predictors for receiving analgesics were older age, longer healing time and being diagnosed via video consultation. CONCLUSION: To identify, assess and treat ulcer pain is equally possible via video as by in-person consultation. The results of this study confirm that patients with hard-to-heal ulcers suffer from high-intensity ulcer pain, with a discrepancy between pain and pain relief. Further well-designed randomised controlled studies are necessary to understand how best to deploy telemedicine in ulcer pain treatment.

Pain and analgaesics in patients with hard-to-heal ulcers: using telemedicine or standard consultations.

OBJECTIVE: To compare consultations carried out via video with those performed in person for patients with painful, hard-to-heal ulcers, with a focus on ulcer pain and pain treatment. A further aim was to investigate predictors for pain and pain treatment. METHOD: This was a register-based, quasi-experimental study based on data from the Swedish Registry of Ulcer Treatment (RUT). A total of 100 patients with hard-to-heal ulcers diagnosed via video consultation were compared with 1888 patients diagnosed in person with regard to pain assessment, intensity and treatment. Ulcer pain intensity was assessed by the visual analogue scale (VAS). Normally distributed variables (age, VAS) were compared between consultation groups using Student's t-test. Non-normally distributed variables (ulcer size, ulcer duration) were compared using the Mann-Whitney U-test, except for healing time, which was analysed with a log-rank test. Categorical variables (gender, ulcer aetiology and prescribed analgesics) were compared using Pearson's chi-square test (χ2). A p value of less than 0.05 was considered to indicate statistical significance. Predictors for pain and pain treatment were analysed in multiple regression analyses. RESULTS: The results showed a high presence of pain; 71% of patients with pain reported severe ulcer pain. There was no significant difference in ability to assess pain by VAS in the group diagnosed via video consultation (90%) compared with the group diagnosed in person (86%) (χ2, p=0.233). A significantly higher amount of prescribed analgesics was found for patients diagnosed via video (84%) compared with patients diagnosed by in-person assessment (68%) (χ2, p=0.044). Predictors for high-intensity pain were female gender or ulcers due to inflammatory vessel disease, while the predictors for receiving analgesics were older age, longer healing time and being diagnosed via video consultation. CONCLUSION: To identify, assess and treat ulcer pain is equally possible via video as by in-person consultation. The results of this study confirm that patients with hard-to-heal ulcers suffer from high-intensity ulcer pain, with a discrepancy between pain and pain relief. Further well-designed randomised controlled studies are necessary to understand how best to deploy telemedicine in ulcer pain treatment.

Does the choice of antiepileptic drug affect survival in glioblastoma patients?

Patients with glioblastoma (GBM) often suffer from symptomatic epilepsy. Older antiepileptic drugs (AEDs) which affect the enzyme system cytochrome P450 have been in extensive use, but there is an increasing focus on interactions with other drugs. This study investigated whether newer AEDs with little or no enzyme effect are increasingly preferred. Previous research has indicated that valproate improves survival in GBM. We investigated the impact of AEDs on overall survival in GBM patients. All GBM patients diagnosed in Norway 2004-2010 were included through a linkage of national registries, and follow-up data on the malignancy and drug usage were analyzed. In a multivariate cox proportional-hazards regression, AEDs were adjusted for each other and for relevant factors. Immortal time bias was eliminated with time-dependent variables. The study population was 1263 patients with histologically confirmed GBM. Carbamazepine was the most frequently prescribed AED to patients diagnosed with GBM during 2004-2006, while levetiracetam was increasingly prescribed to patients diagnosed later. Taking AEDs on a reimbursement code of epilepsy was not beneficial for survival. None of the six AEDs valproate, levetiracetam, carbamazepine, oxcarbazepine, lamotrigine or phenytoin significantly altered overall survival. There has been a shift in the prescriptions of AEDs to GBM patients from older to newer AEDs over time. We found no significant survival benefit in GBM patients neither from treatment with AEDs for epilepsy in general, nor from the usage of six separate AEDs.

Impact of varying outcomes and definitions of suicidality on the associations of antiepileptic drugs and suicidality: comparisons from UK Clinical Practice Research Datalink (CPRD) and Danish national registries (DNR).

PURPOSE: The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS: Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate and valproate) using data from UK Clinical Practice Research Datalink (CPRD) alone and linked to UK Hospital Episode Statistics (HES) and UK Office of National Statistics (ONS), and from Danish national registries (DNR). Follow-up started at initiation of one of the study AEDs, divided into exposure periods, a maximum 90-day post-exposure period, and the reference period starting the day after the 90-day post-exposure period ended. Primary outcomes were completed suicide (SUI)/suicide attempt (SA) for CPRD and SUI/deliberate self-harm (DSH) for DNR. We applied adjusted Cox regression analyses and sensitivity analyses with varying outcome definitions. RESULTS: We analyzed 84,524 AED users from CPRD-HES-ONS (1188 SUI/SA; 96 SUI) and 258,180 users from DNR (7561 SUI/DSH; 781 SUI). The adjusted hazard ratios (HRs) on SUI/SA ranged between 1.3 (95% confidence interval (CI): 0.84-2.00) for lamotrigine and 2.7 (1.24-5.81) for phenytoin in CPRD-HES-ONS, and between 0.9 (0.78-1.00) for valproate and 1.8 (1.10-3.07) for phenytoin on SUI/DSH in DNR. HRs for the primary outcomes varied consistently across exposure periods and data sources. HRs for SUI were in general lower, more stable and similar for periods of exposure and the 90-day post-exposure period. CONCLUSION: Applying different outcomes and definitions of suicidality had an impact on the relative risks of suicidality associated with the investigated AEDs with results for SUI being most consistent and reliable.

Risk of suicidal behavior in patients with major depression and bipolar disorder - A systematic review and meta-analysis of registry-based studies.

Suicide is a health priority and one of the most common causes of death in mood disorders. One of the limitations of this type of research is that studies often establish rates of suicide behaviors in mood disorders by using diverse comparison groups or simply monitoring cohort of patients over a time period. In this registry-based systematic review, national registers were identified through searches in six academic databases, and information about the occurrence of suicide behaviors in mood disorders was systematically extracted. Odds ratios were subsequently calculated comparing rates of death by suicide in mood disorders in comparison with age and period matched rates of death by suicide in the general population obtained from country-wide national registers. The aim was to provide the most recent summary of epidemiological and clinical factors associated to suicide in mood disorders whilst calculating the likelihood of death by suicide in mood disorders in comparison with non-affected individuals according to national databases. The study follows the Preferred Reporting Guidelines for Systematic Reviews and Meta-analyses and was prespecify registered on Prospero (CRD42020186857). Results suggest that patients with mood disorders are at substantially increased risk of attempting and dying by suicide. Several epidemiological, clinical and social factors are reported to be associated with clinical populations at risk of suicide. Meta-analyses of completed deaths by suicide suggest that the likelihood for dying by suicide in mood disorders is 8.62 times higher in major depression and 8.66 times higher in bipolar disorder with higher number of untoward events in women compared to men in both conditions. The likelihood of dying by suicide in major depressive disorders is higher in the first year following discharge. Clinical guidelines might consider longer periods of monitoring following discharge from hospital. Overall, due to the higher risk of suicide in mood disorders, efforts should be made to increase detection and prevention whilst focusing on reducing risk in the most severe forms of illness with appropriate treatment to promote response and remission at the earliest convenience.

Implementing findings from (hip) fracture registries.

The National Health Service in England has successfully used learning from its National Hip Fracture Database to drive improvements in care of the most frail orthopaedic trauma patients. While this could simply be viewed as achieving its primary function, the learning with regard to meaningful change that resulted has been applied across the other aspects of trauma to achieve improvements including multiply injured patients within trauma systems (Trauma Audit and Research Network (TARN)) and community level trauma. This work looks at the lessons that can be learned through the inception and running of a national database, in particular how it can be used as a template to achieve improved care in other aspects of orthopaedic trauma. It explains the UK system and the navigation of this to gain political and administrative traction in the creation of a national network and how this momentum was used to achieve a complete overhaul of the trauma system. There are lessons that are applicable across all healthcare systems.

The implementation of systematic monitoring of cognition in children with cerebral palsy in Sweden and Norway.

PURPOSE: Children with cerebral palsy (CP) are at risk of cognitive impairments and need to be cognitively assessed to allow for individualized interventions, if applicable. Therefore, a systematic protocol for the follow-up of cognition in children with CP, CPCog, with assessments offered at five/six and 12/13 years of age, was developed. This report presents and discusses assessment practices in Sweden and Norway following the introduction of CPCog and a quality improvement project in Norway aimed at increasing the number of children offered cognitive assessments. MATERIALS AND METHODS: A questionnaire investigating assessment practices was sent to pediatric habilitation centers in Sweden and Norway. In Norway, the habilitation centers also participated in a quality improvement project aimed at increasing adherence to the CPCog protocol. RESULTS: Of the respondents, 64-70% report that they assess cognition in children with all degrees of motor impairment, and 70-80% assess at the ages recommended in CPCog. Following the quality improvement project in Norway, the percentage of children assessed increased from 34 to 62%. CONCLUSIONS: The findings illustrate that the provision of information is not sufficient to change practice. Implementation of new re/habilitation procedures is aided by targeting health care practices individually.Implications for rehabilitationChildren with cerebral palsy (CP) have increased risk of cognitive impairments that require intervention.Assessments of cognition should be offered to all children with CP because the nature of cognitive impairments may vary.Introducing a follow-up protocol of how and when to perform cognitive assessments is a step towards ensuring equal access to the services for all children with CP.A quality improvement project might be a viable method for implementing a protocol into everyday clinical practice.

Exploring the Gantt chart as a tool to highlight double report in case series published during the first wave of the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, some studies describing different aspects of the infection included very similar participants, rising suspicion about double reporting. We aimed to evaluate the Gantt chart as a tool to highlight possible double reporting. The chart is routinely used in business applications to depict tasks of a project, by plotting horizontal bars against time, showing their time span and overlaps. METHODS: All case reports and case series of pregnant women with COVID-19, published by July 15, 2020, were included. Initial and final dates of participants' enrollment, country, city, hospital, and number of pregnancies were plotted in the Gantt chart. Bars stand for enrollment dates of each study, according to hospital and city, thus allowing comparisons. RESULTS: We included 116 articles in the present analysis. The Gantt chart highlighted papers in which some participants were likely the same, thus allowing easier identification of double reporting of cases. Combining all information and pregnancy characteristics and outcomes helped to recognize duplications when the authors did not acknowledged the previous publication. CONCLUSIONS: Unintended double reporting may occur, especially in exceptional times. The Gantt chart may help researchers to visually identify potential duplications, thus avoiding biased estimates in systematic reviews or meta-analysis.

Insulin Pump Treatment in Adults with Type 1 Diabetes in the Capital Region of Denmark: Design and Cohort Characteristics of the Steno Tech Survey.

INTRODUCTION: Insulin pump therapy can improve quality of life and glycaemic outcomes for many people with type 1 diabetes (T1D). The multidimensional Steno Tech Survey study aims to investigate why some insulin pump users do not achieve treatment goals. In this article, we present the study design and analyse differences in population characteristics between responders and non-responders. METHODS: In June 2020, all 1591 insulin pump users (≥ 18 years) in the Capital Region of Denmark were invited to participate in an online questionnaire that evaluated several dimensions of insulin pump self-management and psychosocial health. Demographic, socioeconomic and clinical characteristics, including age, sex and HbA1c, of the cohort were identified via national registries. Predictors of questionnaire response/non-response were explored with logistic regression analysis. RESULTS: In the full study population, 58% were female, median age was 42 years and median HbA1c was 58 mmol/mol (7.5%); 30% had HbA1c < 53 mmol/mol (7.0%). In total, 770 individuals (48%) responded to the questionnaire. Logistic regression analysis showed that 50+ years of age (odds ratio [OR] = 2.3, 95% confidence interval [CI]: 1.4-3.8), female sex (OR = 1.3, CI: 1.02-1.6), being married (OR = 1.8, CI: 1.3-2.4) and having long higher education (OR = 1.6, CI: 1.004-2.5) were significantly associated with a higher likelihood of responding to the survey; the opposite was found for HbA1c from 64 to < 75 mmol (8.0-9.0%) (OR = 0.6, CI: 0.4-0.8) and HbA1c ≥ 75 mmol/mol (≥ 9.0%) (OR = 0.2, CI: 0.1-0.3). CONCLUSIONS: The established Steno Tech cohort enables future analysis of a range of psychosocial and behavioural aspects of insulin pump self-management. Interpretation and generalization of findings should consider observed differences between responders and non-responders.

Differences in characteristics, treatments and outcomes in patients with non-ST-elevation myocardial infarction: novel insights from four national European continuous real-world registries.

AIMS: To study baseline characteristics, in-hospital managements and mortality of non-ST-elevation myocardial infarction (NSTEMI) patients in different European countries. METHODS AND RESULTS: NSTEMI patients enrolled in the national myocardial infarction (MI) registries [EMIR; n = 5817 (Estonia), HUMIR; n = 30 787 (Hungary), NORMI; n = 33 054 (Norway), and SWEDEHEART; n = 49 533 (Sweden)] from 2014 to 2017 were included and presented as aggregated data. The median age at admission ranged from 70 to 75 years. Current smoking status was numerically higher in Norway (24%), Estonia (22%), and Hungary (19%), as compared to Sweden (17%). Patients in Hungary had a high rate of diabetes mellitus (37%) and hypertension (84%). The proportion of performed coronary angiographies (58% vs. 75%) and percutaneous coronary interventions (38% vs. 56%), differed most between Norway and Hungary. Prescription of dual antiplatelet therapy at hospital discharge ranged from 60% (Estonia) to 81% (Hungary). In-hospital death ranged from 3.5% (Sweden) to 9% (Estonia). The crude mortality rate at 1 month was 12% in Norway and 5% in Sweden (5%), whereas the 1-year mortality rates were similar (20-23%) in Hungary, Estonia, and Norway and 15% in Sweden. CONCLUSION: Cross-comparisons of four national European MI registries provide important data on differences in risk factors and treatment regiments that may explain some of the observed differences in death rates. A unified European continuous MI registry could be an option to better understand how implementation of guideline-recommended therapy can be used to reduce the burden of cardiovascular disease.

Association between ß-blocker dose and quality of life after myocardial infarction: a real-world Swedish register-linked study.

BACKGROUND: ß-blockers are routinely administered to patients following myocardial infarction (MI), yet their potential effect on health-related quality of life (HRQoL) is not entirely understood. We investigated the relationship between two different doses of ß-blockers with HRQoL following MI. METHODS AND RESULTS: This nationwide observational study used Swedish national registries to collate sociodemographic, clinical, medication, and HRQoL {the latter operationalized using EuroQol [European Quality of Life Five Dimensions Questionnaire (EQ-5D)]}. Estimates at 6-10 weeks and 12-14 months post-MI follow-up from pooled linear and logistic models were calculated after multiple imputation. We identified 35 612 patients with first-time MI, discharged with ß-blockers, and enrolled in cardiac rehabilitation between 2006 and 2015. Upon discharge, patients were either dispensed <50% [24 082 (67.6%)] or ≥50% [11 530 (32.4%)] of the target dosage, as defined in previous trials. After adjusting for pre-defined covariates, neither the EQ-5D Index nor the Emotional Distress items were statistically different between groups. The EQ-VAS score was significantly lower in patients treated with ≥50% target ß-blocker dose than those treated with <50% of the target dose [-0.87 [-1.23, -0.46], P < .001]. Results were similar at the 12-month follow-up and across sub-groups separated by sex and age. CONCLUSION: No difference in HRQoL was found among patients taking <50% vs. ≥50% of the target ß-blocker dose, except for the EQ-VAS in which higher scores were reported in those taking a lower dose. The clinical meaningfulness of this statistical significance is likely low.

Registrations of Patients with Renal Cell Carcinoma in the Nationwide Danish Renal Cancer Database versus the Danish Cancer Registry: Data Quality, Completeness and Survival (DaRenCa Study-3).

BACKGROUND: The Danish multidisciplinary renal cancer group (DaRenCa) established the nationwide database DaRenCaData in 2010. The Danish Cancer Registry (DCR) has been considered the golden standard. In contrast to DCR, DaRenCaData required the diagnosis to be histologically or cytologically verified. DaRenCaData and DCR have not previously been compared. PATIENTS AND METHODS: We included patients with renal cell carcinoma registered in DaRenCaData and/or DCR from August 1st 2010 to December 31st 2015. We computed completeness and positive predictive value (PPV) of a diagnosis in DaRenCaData compared with DCR, 1-year, 3-year and 5-year mortality rate ratios, and relative survival. RESULTS: We identified 4890 patients in the two registries. Of these, 4326 were registered in DaRenCaData and 4714 in DCR. Completeness of DaRenCaData was 88% [95% CI, 87-89%] and increased during the period from 82% to 94%. The PPV was 96% [95% CI, 95-97%]. A total of 4150 patients (85%) were found in both registries, 4% (176 patients) in DaRenCaData only, and 12% (564 patients) in DCR only. The relative survival was higher for patients in DaRenCaData vs DCR; the 1-year and 5-year relative survival was 85% vs 81% and 65% vs 59%, respectively. Compared with patients registered in both registries, the mortality rates were higher in patients registered in DaRenCaData only (1-year hazard ratio (HR)=2.84 [95% CI, 2.20-3.68]) or DCR only (1-year HR=4.29 [95% CI, 3.72-4.93]). Observed in both registries, survival improved over time with a 7% yearly reduction in death based on estimations of 1-year mortality rate ratios. CONCLUSION: DaRenCaData had high and increasing completeness and high PPV, establishing it as a high-quality research database. Observed in both registries, renal cell carcinoma mortality declined over time; patients only registered in DCR or DaRenCaData had poorer outcomes. This study points to the importance of assessing the inclusion criteria when interpreting registry-based studies.

Trends in Knee and Hip Arthroplasty in Chile Between 2004 and 2019.

Introduction The purpose of this study is to describe the incidence rate (IR) per 100,000 inhabitants of arthroplasty in Chile between 2004 and 2019, emphasizing knee and hip arthroplasty. Methods This is a cross-sectional study. Patients who underwent arthroplasty between 2004 and 2019 were identified in the free access database of the Chilean Department of Statistics and Health Information (DEIS), which depends directly on the Ministry of Health. This register stores all hospital discharges of the country from private or public health centers. The trend during the period of study was analyzed using Spearman's correlation. Results From a total of 111,303 patients, 133,518 arthroplasties were performed. Hip arthroplasty (HA) accounted for 73.35%, followed by knee arthroplasty (KA) (23,92%). A significant upward trend was found in HA (rho=0.95, p<0.000) and KA (rho=0.98, p<0.000). Most of the surgeries were done within the Public Health Network (61,6%), but 20% of patients affiliated with public insurance underwent arthroplasty in a private center. Patients above 60 years of age affiliated with private insurance underwent 1.8 HA and 2.5 KA for every one HA and KA undergone by patients of the same age group who were affiliated with public insurance. Conclusion HA was more frequent than KA. A significant gap was found in the incidence of arthroplasty as compared to countries belonging to the Organization for Cooperation and Economic Development, given by a less aged population and by inequity in health access. Wider coverage and a national registry for arthroplasty must be considered in Chilean health policies.

Perspectives in the Rapidly Evolving Treatment Landscape of Multiple Myeloma: Expert Review of New Data Presentations from ASH 2019.

The number and type of therapeutic options available to treat patients with multiple myeloma has risen dramatically over recent years, offering exciting opportunities to significantly improve the future management of this currently incurable disease. Some of the latest advances in the settings of newly diagnosed and relapsed/refractory multiple myeloma were presented at the 61st Annual Meeting of the American Society of Hematology (Orlando, Florida, December 7 to 10, 2019) and are reviewed in this article with accompanying expert commentary. Presentations covered the use of registry-generated real-world data to define the characteristics of 'functional' high-risk patients in order to enable early therapeutic intervention for this poor-prognosis subset; studies that reported impressive new and updated data with novel combinations of targeted agents across different settings, including biomarker-specific subgroups; and promising early-phase data with novel immunotherapeutic approaches, such as bispecific antibodies and chimeric antigen receptor T-cell B-cell maturation antigen-directed therapies. This review offers insights into how these latest developments may fit within the rapidly evolving treatment landscape. The adoption and optimal use of novel therapies may be impacted by logistical challenges such as limited funding and access to necessary infrastructure to provide these treatments. In this manuscript, we focus particularly on Asia-Pacific regions and identify areas for development, such as establishment of robust national registries, promotion of investigator-initiated trials, compassionate-use treatment programs, and collaboration between jurisdictions with similar patterns of care. The hope is that such efforts will augment research outputs and ultimately translate into improved patient outcomes in the real world.

Societal costs due to meningococcal disease: a national registry-based study.

PURPOSE: Limited detailed evidence exists on the societal costs of meningococcal disease. The objective of this study was to estimate the average 5-year societal cost of events attributable to meningococcal disease in Denmark. METHODS: The study was based on the nationwide Danish registries. Incident patients diagnosed with meningococcal disease were identified and each matched with two controls, using direct matching on age, gender, and level of education. Siblings constituted a secondary control population where one patient was matched with one sibling control without meningococcal disease. Costs related to health care in the primary and secondary sectors, prescription medicine, municipality home care services and costs of production loss, ie, estimated loss of yearly earnings, were included (1997-2015). RESULTS: The incidence of meningococcal disease fluctuated between 1980 and 2015. The average attributable societal costs were highest the first year after diagnosis, with costs equaling USD 18,920 per event in the primary study population (matched controls) and USD 16,169 in the secondary study population (sibling controls). Hospital admission costs accounted for 65% and production loss for 30%; however, having a lifetime perspective and including loss due to premature death further increase the costs of meningococcal disease events. CONCLUSION: The costs of meningococcal disease are substantial, and the estimated costs of event may be informative in evaluating the impact of preventive interventions targeting meningococcal disease.

Predictors of an inadequate defibrillation safety margin at ICD implantation: insights from the National Cardiovascular Data Registry.

BACKGROUND: Defibrillation testing is often performed to establish effective arrhythmia termination, but predictors and consequences of an inadequate defibrillation safety margin (DSM) remain largely unknown. OBJECTIVES: The aims of this study were to develop a simple risk score predictive of an inadequate DSM at implantable cardioverter-defibrillator (ICD) implantation and to examine the association of an inadequate DSM with adverse events. METHODS: A total of 132,477 ICD Registry implantations between 2010 and 2012 were analyzed. Using logistic regression models, factors most predictive of an inadequate DSM (defined as the lowest successful energy tested <10 J from maximal device output) were identified, and the association of an inadequate DSM with adverse events was evaluated. RESULTS: Inadequate DSMs occurred in 12,397 patients (9.4%). A simple risk score composed of 8 easily identifiable variables characterized patients at high and low risk for an inadequate DSM, including (with assigned points) age <70 years (1 point); male sex (1 point); race: black (4 points), Hispanic (2 points), or other (1 point); New York Heart Association functional class III (1 point) or IV (3 points); no ischemic heart disease (2 points); renal dialysis (3 points); secondary prevention indication (1 point); and ICD type: single-chamber (2 points) or biventricular (1 point) device. An inadequate DSM was associated with greater odds of complications (odds ratio: 1.22; 95% confidence interval: 1.09 to 1.37; p = 0.0006), hospital stay >3 days (odds ratio: 1.24; 95% confidence interval: 1.19 to 1.30; p < 0.0001), and in-hospital mortality (odds ratio: 1.96; 95% confidence interval: 1.63 to 2.36; p < 0.0001). CONCLUSIONS: A simple risk score identified ICD recipients at risk for an inadequate DSM. An inadequate DSM was associated with an increased risk for in-hospital adverse events.

Event detection using population-based health care databases in randomized clinical trials: a novel research tool in interventional cardiology.

AIM: To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials. BACKGROUND: Randomized clinical trials often focus on short-term efficacy and safety in a controlled environment. Trial follow-up may be linked with study-related investigations and differ from routine clinical practice. Because treatment and control in randomized trials differ from daily practice, trial results may have reduced general applicability and may be of limited value in clinical decision-making. Further, it is economically very costly to conduct randomized clinical trials. METHODS AND RESULTS: Population-based health care databases collect data continuously and prospectively, and make it possible to monitor lifelong outcomes of cardiac interventions in large numbers of patients. This strengthens external validity by eliminating the effects of study-related monitoring or diagnostic tests. Further, follow-up data can be obtained at low expense. Importantly, data sources encompassing a complete population are likely to reflect clinical practice. Because population-based health care databases collect data for quality-control and administrative purposes unrelated to scientific investigations, certain biases, such as nonresponse bias, recall bias, and bias from losses to follow-up, can be avoided. CONCLUSION: Event detection using population-based health care databases is a new research tool in interventional cardiology that may allow large, low-cost, randomized clinical trials to reflect daily clinical practice, covering a broad range of patients and end points with complete lifelong follow-up.

Low body mass index but not obesity is associated with in-hospital adverse events and mortality among implantable cardioverter-defibrillator recipients: insights from the National Cardiovascular Data Registry.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are placed in patients at risk for sudden cardiac death, but the procedure may cause adverse events. Patient body habitus may be an important factor responsible for ICD implantation complications. We assessed whether underweight or obese compared with normal weight patients, as defined by body mass index (BMI), were at increased risk for adverse events from ICD implantation. METHODS AND RESULTS: We studied 83 312 first-time ICD recipients in the National Cardiovascular Data Registry-ICD Registry implanted between April 2010 and June 2011. Using hierarchical multivariable logistic regression adjusted for patient demographic and clinical characteristics, we examined the association of BMI with in-hospital complications, length of hospital stay, and mortality. Underweight (BMI ≤ 18.5 kg/m(2)) patients comprised 1.7% of the cohort (n=1434), whereas obese (BMI ≥ 30 kg/m(2)) patients comprised 40.1% (n=33 339). Overall, a higher proportion of underweight patients experienced complications (normal weight, 2.3%; obese, 2.1%; underweight 5.2%; P<0.0001) and death (normal weight, 0.3%; obese, 0.3%; underweight 0.8%; P=0.026) as a result of ICD implantation. After multivariable adjustment, underweight ICD recipients had a greater odds of complications (odds ratio [OR], 2.15; 95% confidence interval [CI], 1.68 to 2.75; P<0.0001), hospital stay >3 days (OR, 1.62; 95% CI, 1.38 to 1.89; P<0.0001), and in-hospital death (OR, 2.27; 95% CI, 1.21 to 4.27; P=0.011) compared with normal weight patients. Obese patients did not exhibit any meaningful differences in the same outcomes. CONCLUSIONS: In a large, real-world population, underweight first-time ICD recipients experienced significantly more periprocedural complications, prolonged hospital stays, and in-hospital death compared with normal weight patients.