Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint.

INTRODUCTION: Some retrospective data sources, such as electronic health records in the USA, report composite outcome measures not fully validated in psoriatic arthritis (PsA). However, they often contain global assessments, such as a Physician Global Assessment (PhGA) and Patient Global Assessment (PatGA), along with patient-reported pain scores, which individually are considered validated in PsA. This research described the performance characteristics of a 3-item global assessment and pain (GAP) composite endpoint using data from the ixekizumab phase 3 PsA clinical trial program. METHODS: Discrimination of GAP was assessed by comparing placebo to active treatment arms. The magnitude of treatment effect and responsiveness were compared to Disease Activity Index for PsA (DAPSA), clinical DAPSA, DAPSA28, and Psoriatic Arthritis Disease Activity Score (PASDAS) using effect size (ES) and standardized response mean (SRM), respectively. Construct validity was evaluated through correlation among the composite endpoints, and with other physician- and patient-reported outcomes. Change in GAP was compared in patients who reached low disease activity (LDA) levels based on DAPSA, cDAPSA, and PASDAS vs those who did not. RESULTS: GAP discriminated between active treatment and placebo with statistically significant separation as early as week 1. The largest ES/SRM was seen with GAP (2.29/1.74) and PASDAS (2.47/1.68). GAP had the strongest correlation with PASDAS (0.81-0.92) and showed moderate correlations with patient-assessed physical function, low correlations with physician-assessed skin and nail psoriasis, and low to moderate correlation with physician-assessed enthesitis. A significantly greater improvement in GAP was seen in the groups achieving LDA states compared to those not (p < 0.001). CONCLUSION: The GAP composite, an abbreviated endpoint comprising measures common in electronic health records, has promising performance characteristics and could be used to address important clinical questions regarding outcomes and impact of PsA in existing datasets. CLINTRIALS. GOV IDENTIFIER: NCT01695239; NCT02349295.

When doctors are assessing patients with psoriatic arthritis in clinical trials, they use tools, which include questions that patients answer and questions that doctors answer, in addition to a physical exam, to help evaluate how patients are doing. In a routine clinical practice setting, all of these same tools may not be used because they take a longer time to document information during a patient office visit. The goals of this research were to (1) create a new tool, which uses questions that patients and doctors answer, to help doctors evaluate how patients with psoriatic arthritis are doing in routine clinical practice, and (2) to assess if this new tool works as well as older tools. The new tool has fewer questions for the doctor and patient to answer and may take less time to document information but may result in some symptoms that patients experience not being regularly assessed. Data from clinical trials were used to compare the new tool to older tools to evaluate if doctors are able to assess psoriatic arthritis the same way. The results of the study showed that doctors are able to assess patients with psoriatic arthritis similarly with the new tool compared to older tools. This information will increase awareness of the new tool and could make it easier for doctors to evaluate patients with psoriatic arthritis in routine clinical practice.

Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity.

INTRODUCTION: Skin involvement in patients with psoriatic arthritis (PsA) worsens the severity and burden of disease. Ixekizumab (IXE), a selective interleukin (IL)-17A antagonist, was compared to placebo (PBO) in the SPIRIT-P1 (NCT01695239) and SPIRIT-P2 (NCT02349295) studies in patients with PsA and evidence of plaque psoriasis. This post hoc analysis reports musculoskeletal, skin, and nail outcomes through week 24 in patients from SPIRIT-P1 and SPIRIT-P2, stratified by mild, moderate, or psoriasis at baseline. METHODS: This post hoc analysis pooled patients from SPIRIT-P1 and SPIRIT-P2 who were randomly assigned to PBO or IXE 80 mg every 4 weeks (Q4W) or every 2 weeks (Q2W). Efficacy outcomes were analyzed through week 24 by baseline psoriasis severity, defined by percent body surface area (BSA) affected; mild = BSA < 3%, moderate = 3% ≤ BSA ≤ 10%, severe = BSA > 10%. The primary outcomes assessed were the proportion of patients achieving American College of Rheumatology (ACR)20, ACR50, and ACR70 responses. Secondary outcomes included musculoskeletal, disease activity, skin and nail, and health-related quality-of-life measures. RESULTS: Similar proportions of patients achieved ACR20/ACR50/ACR70 over time across all severity subgroups and treatment arms. More than one-third of IXE-treated patients achieved ACR20 at week 4, or ACR50 at week 24, with no significant differences according to psoriasis severity at baseline. Disease activity outcomes were similar through week 24 with both IXEQ4W and IXEQ2W, regardless of psoriasis severity at baseline. There were no significant differences over 24 weeks in the proportions of IXE-treated patients with mild, moderate, or severe baseline psoriasis who achieved Minimal Disease Activity (MDA). Across all severity subgroups, IXE demonstrated Psoriasis Area Severity Index 100 response as early as week 4, and approximately one-third of IXE-treated patients achieved total skin clearance at week 24. CONCLUSION: IXE demonstrated rapid and consistent efficacy in joint, skin, and nail for patients with PsA, regardless of baseline psoriasis severity. TRIAL REGISTRATION: SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295).

Clinical validation and evaluation of a novel six-lead handheld electrocardiogram recorder compared to the 12-lead electrocardiogram in unselected cardiology patients (EVALECG Cardio).

Aims: Handheld electrocardiogram (ECG) monitors are increasingly used by both healthcare workers and patients to diagnose cardiac arrhythmias. There is a lack of studies validating the use of handheld devices against the standard 12-lead ECG. The Kardia 6L is a novel handheld ECG monitor which can produce a 6-lead ECG. In this study, we compare the 6L ECG against the 12-lead ECG. Methods and results: A prospective study consisting of unselected cardiac inpatients and outpatients at Leeds Teaching Hospital NHS Trust. All participants had a 12- and 6-lead ECGs. All ECG parameters were analysed by using a standard method template for consistency between independent observers. Electrocardiograms from the recorders were compared by the following statistical methods: linear regression, Bland-Altman, receiver operator curve, and kappa analysis. There were 1015 patients recruited. The mean differences between recorders were small for PR, QRS, cardiac axis, with receiver operator analysis area under the curve (AUC) of >80%. Mean differences for QT and QTc (between recorders) were also small, with AUCs for QT leads of >75% and AUCs for QTc leads of >60%. Key findings from Bland-Altman analysis demonstrate overall an acceptable agreement with few outliers instances (<6%, Bland-Altman analysis). Conclusion: Several parameters recorded by the Kardia 6L (QT interval in all six leads, rhythm detection, PR interval, QRS duration, and cardiac axis) perform closely to the gold standard 12-lead ECG. However, that consistency weakens for left ventricular hypertrophy, QRS amplitudes (Lead I and AVL), and ischaemic changes.

A Systematic Review of the Spectrum of Cardiac Arrhythmias in Sub-Saharan Africa.

Major structural cardiovascular diseases are associated with cardiac arrhythmias, but their full spectrum remains unknown in sub-Saharan Africa (SSA), which we addressed in this systematic review. Atrial fibrillation/atrial flutter (AF/AFL) prevalence is 16-22% in heart failure, 10-28% in rheumatic heart disease, 3-7% in cardiology admissions, but <1% in the general population. Use of oral anticoagulation is heterogenous (9-79%) across SSA. The epidemiology of sudden cardiac arrest/death is less characterized in SSA. Cardiopulmonary resuscitation is challenging, owing to low awareness and lack of equipment for life-support. About 18% of SSA countries have no cardiac implantable electronic devices services, leaving hundreds of millions of people without any access to treatment for advanced bradyarrhythmias, and implant rates are more than 200-fold lower than in the western world. Management of tachyarrhythmias is largely non-invasive (about 80% AF/AFL via rate-controlled strategy only), as electrophysiological study and catheter ablation centers are almost non-existent in most countries. Highlights: - Atrial fibrillation/flutter prevalence is 16-22% in heart failure, 10-28% in rheumatic heart disease, 3-7% in cardiology admissions, and <1% in the general population in sub-Saharan Africa (SSA).- Rates of oral anticoagulation use for CHA2DS2VASC score ≥2 are very diverse (9-79%) across SSA countries.- Data on sudden cardiac arrest are scant in SSA with low cardiopulmonary resuscitation awareness.- Low rates of cardiac implantable electronic devices insertions and rarity of invasive arrhythmia treatment centers are seen in SSA, relative to the high-income countries.

Incidence of recreational sports-related sudden cardiac arrest in participants over age 12 in a general African population.

BACKGROUND: The incidence of sports-related sudden cardiac arrest (SrSCA) in sub-Saharan Africa is unknown. OBJECTIVE: To determine the incidence of sudden cardiac arrest (SCA) in non-competitive athletes in an urban population of Cameroon, a country in sub-Saharan Africa. METHODS: Two study populations in Cameroon were used. A 12-month, multisource surveillance system of 86 189 inhabitants over 12 years old recorded all deaths in two administrative districts of Douala City. All fields of sports, emergency medical service, local medical examiners and district hospital mortuaries were surveyed. Two blinded cardiologists used a verbal autopsy protocol to determine the cause of death. SCA was identified for all deaths occurring within 1 hour of onset of symptoms. A cross-sectional study was conducted among 793 persons in Yaoundé City, which is the second study population aimed at determining the proportion of people who are physically active. RESULTS: The mean age in the cross-sectional study was 27.3±10.7, with more men (56.2%). The cross-sectional study showed that 69.0% (95% CI 65.8 to 72.2) of the population could be considered to have at least 3 hours of physical activity per week. The surveillance found that among 288 all-cause deaths, 27 (9.4%) were due to SCA. One SrSCA was registered in a 35-year-old woman while running. Merging both sources revealed an SrSCA incidence of 1.7 (95% CI 0.2 to 12.0) cases per 100 000 athletes per year. CONCLUSION: This pioneer study reports the incidence estimates of SrSCA in a sub-Saharan African general population and should be regarded as a first step to a big problem.

Cardiac Pacing Training in Africa: Endorsed by the Africa Heart Rhythm Association (AFHRA): JACC International.

The field of pacing in Africa has evolved in an uncoordinated way across the continent with significant variation in local expertise, cost, and utilization. There are many countries where pacemaker services do not meet one-hundredth of the national demand. Regional, national, and institutional standards for pacemaker qualification and credentials are lacking. This paper reviews the current needs for bradycardia pacing and evaluates what standards should be set to develop pacemaker services in a resource-constrained continent, including the challenges and opportunities of capacity building and training as well as standards for training programs (training prerequisites, case volumes, program content, and evaluation).

Cardiac arrhythmia services in Africa from 2011 to 2018: the second report from the Pan African Society of Cardiology working group on cardiac arrhythmias and pacing.

AIMS: Cardiac arrhythmia services are a neglected field of cardiology in Africa. To provide comprehensive contemporary information on the access and use of cardiac arrhythmia services in Africa. METHODS AND RESULTS: Data on human resources, drug availability, cardiac implantable electronic devices (CIED), and ablation procedures were sought from member countries of Pan African Society of Cardiology. Data were received from 23 out of 31 countries. In most countries, healthcare services are primarily supported by household incomes. Vitamin K antagonists (VKAs), digoxin, and amiodarone were available in all countries, while the availability of other drugs varied widely. Non-VKA oral anticoagulants (NOACs) were unequally present in the African markets, while International Normalized Ratio monitoring was challenging. Four countries (18%) did not provide pacemaker implantations while, where available, the implantation and operator rates were 2.79 and 0.772 per million population, respectively. The countries with the highest pacemaker implantation rate/million population in descending order were Tunisia, Mauritius, South Africa, Algeria, and Morocco. Implantable cardioverter-defibrillator and cardiac resynchronization therapy (CRT) were performed in 15 (65%) and 12 (52%) countries, respectively. Reconditioned CIED were used in 5 (22%) countries. Electrophysiology was performed in 8 (35%) countries, but complex ablations only in countries from the Maghreb and South Africa. Marked variation in costs of CIED that severely mismatched the gross domestic product per capita was observed in Africa. From the first report, three countries have started performing simple ablations. CONCLUSION: The access to arrhythmia treatments varied widely in Africa where hundreds of millions of people remain at risk of dying from heart block. Increased economic and human resources as well as infrastructures are the critical targets for improving arrhythmia services in Africa.

Cardiac Arrhythmias in Africa: Epidemiology, Management Challenges, and Perspectives.

Africa is experiencing an increasing burden of cardiac arrhythmias. Unfortunately, the expanding need for appropriate care remains largely unmet because of inadequate funding, shortage of essential medical expertise, and the high cost of diagnostic equipment and treatment modalities. Thus, patients receive suboptimal care. A total of 5 of 34 countries (15%) in Sub-Saharan Africa (SSA) lack a single trained cardiologist to provide basic cardiac care. One-third of the SSA countries do not have a single pacemaker center, and more than one-half do not have a coronary catheterization laboratory. Only South Africa and several North African countries provide complete services for cardiac arrhythmias, leaving more than hundreds of millions of people in SSA without access to arrhythmia care considered standard in other parts of the world. Key strategies to improve arrhythmia care in Africa include greater government health care funding, increased emphasis on personnel training through fellowship programs, and greater focus on preventive care.

Effect of a brief motivational intervention in reducing alcohol consumption in the emergency department: a randomized controlled trial.

BACKGROUND: Introduction to alcohol consumption early in life increases the risk of alcohol dependency and hence motivational interventions are needed in young patients visiting the emergency department (ED). AIM: This study aims to investigate the efficacy of a brief motivational intervention in reducing alcohol consumption among young ED patients. PATIENTS AND METHODS: This was a blind randomized controlled trial with follow-up at 3 months. Patients were stratified on the basis of age and blood alcohol level of 0.5 g/l or more. A total of 263 patients aged 16-24 were randomized, with 132 patients in the brief motivational intervention group and 131 in the control group, with data collection at 3 months. From September 2011 to July 2012, a psychologist performed the brief motivational intervention 5 days after the patients' discharge. A phone call was made at 1 and 2 months. The control group received a self-assessment leaflet. The reduction in consumption was determined on the basis of the number of drinks consumed in the last week prior to the survey. RESULTS: The mean reduction between number of drinks at baseline and number of drinks at 3 months in the control group was 0.3 and that in the intervention group was 0.9. This reduction in alcohol use in the brief motivational intervention group was not significant. The study did not show an association between brief motivational intervention and repeated drunkenness [relative risk (RR): 0.99, 95% confidence interval (CI): 0.79-1.24], alcohol consumption at least once a month (RR: 0.81, 95% CI: 0.31-2.10) and alcohol consumption at least 10 times during the month (RR: 1.1, 95% CI: 0.96-1.26). CONCLUSION: We did not observe a significant decrease in alcohol consumption among the youth. Further studies are needed to confirm the positive impact of a brief motivational intervention in the ED.

Revisiting Factors Associated With Screen Time Media Use: A Structural Study Among School-Aged Adolescents.

BACKGROUND: Screen-based media overuse has been related to harmful consequences especially among children and adolescents. Given their complex interrelationships, predictors of screen time (ST) should be analyzed simultaneously rather than individually to avoid incomplete conclusions. METHODS: Structural equation models were conducted to examine associations between media ST (television, video games, and computers) along with harmful consequences in adolescents' well-being, such as underweight and overweight, depression, and school failure. Predictors included individual (gender, age, and physical activity), family (structure and socioeconomic background), and substance use variables. We used the Health Behaviour in School-aged Children survey organized in 2014, including eighth- and ninth-grade students living in France (N = 3720). RESULTS: Students reported spending 3 hours per day in front of each media. Spending more than 2 hours behind each of those 3 media was associated with lower life satisfaction, less physical activity, active school bullying, and grade repetition. Socioeconomic status was the most important predictor of ST, whereas regular substance uses showed modest associations. CONCLUSION: The main implication of our findings is to sensitize parents and stakeholders about the limitation of ST, including their own use that adolescents are likely to mimic. Alternative measures such as off-line time should be encouraged.

Statistics on the use of cardiac electronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces.

Aims: To provide comprehensive information on the access and use of cardiac implantable electronic devices (CIED) and catheter ablation procedures in Africa. Methods and results: The Pan-African Society of Cardiology (PASCAR) collected data on invasive management of cardiac arrhythmias from 2011 to 2016 from 31 African countries. A specific template was completed by physicians, and additional information obtained from industry. Information on health care systems, demographics, economics, procedure rates, and specific training programs was collected. Considerable heterogeneity in the access to arrhythmia care was observed across Africa. Eight of the 31 countries surveyed (26%) did not perform pacemaker implantations. The median pacemaker implantation rate was 2.66 per million population per country (range: 0.14-233 per million population). Implantable cardioverter-defibrillator and cardiac resynchronization therapy were performed in 12/31 (39%) and 15/31 (48%) countries respectively, mostly by visiting teams. Electrophysiological studies, including complex catheter ablations were performed in all countries from Maghreb, but only one sub-Saharan African country (South Africa). Marked variation in cost (up to 1000-fold) was observed across countries with an inverse correlation between implant rates and the procedure fees standardized to the gross domestic product per capita. Lack of economic resources and facilities, high cost of procedures, deficiency of trained physicians, and non-existent fellowship programs were the main drivers of under-utilization of interventional cardiac arrhythmia care. Conclusion: There is limited access to CIED and ablation procedures in Africa. A quarter of countries did not have pacemaker implantation services, and catheter ablations were only available in one country in sub-Saharan Africa.

Fractional exhaled nitric oxide as a predictor of response to inhaled corticosteroids in patients with non-specific respiratory symptoms and insignificant bronchodilator reversibility: a randomised controlled trial.

BACKGROUND: Chronic non-specific respiratory symptoms are difficult to manage. This trial aimed to evaluate the association between baseline fractional exhaled nitric oxide (FeNO) and the response to inhaled corticosteroids in patients with non-specific respiratory symptoms. METHODS: In this double-blind randomised placebo-controlled trial, we enrolled undiagnosed patients, aged 18-80 years, with cough, wheeze, or dyspnoea and less than 20% bronchodilator reversibility across 26 primary care centres and hospitals in the UK and Singapore. Patients were assessed for 2 weeks before being randomly assigned (1:1) to 4 weeks of treatment with extrafine inhaled corticosteroids (QVAR 80 µg, two puffs twice per day, equivalent to 800 µg per day beclomethasone dipropionate) or placebo. Randomisation was stratified by baseline FeNO measurement: normal (≤25 parts per billion [ppb]), intermediate (>25 tp <40 ppb), and high (≥40 ppb). The primary endpoint was change in Asthma Control Questionnaire (ACQ7) mean score. We used generalised linear modelling to assess FeNO as a predictor of response, estimating an interaction effect between FeNO and treatment on change in ACQ7. We did our primary and secondary analyses in the per-protocol set, which excluded patients with non-completion of the primary endpoint, non-compliance to treatment (ascertained by patient report), and study visits made outside the predefined visit windows. This study is registered on ClinicalTrials.gov, number NCT02294279. FINDINGS: Between Feb 4, 2015, and July 12, 2016, we randomly assigned 294 patients to extrafine inhaled corticosteroid treatment (n=148) or placebo (n=146). Following exclusions due to protocol violations, we analysed 214 patients (114 extrafine inhaled corticosteroids and 100 placebo). We observed a significant interaction between baseline FeNO and treatment group for every 10 ppb increase in baseline FeNO, with the change in ACQ7 greater in the extrafine inhaled corticosteroids group than in the placebo group (difference between groups 0·071, 95% CI 0·002 to 0·139; p=0·044). The most common adverse events were nasopharyngitis (18 [12%] patients in the treatment group vs 13 [9%] in the placebo group), infections and infestations (25 [17%] vs 21 [14%]), and respiratory, thoracic, and mediastinal disorders (13 [9%] vs 17 [12%]). INTERPRETATION: FeNO measurement is an easy and non-invasive tool to use in clinical practice in patients with non-specific respiratory symptoms to predict response to inhaled corticosteroids. Further research is needed to examine its role in patients with evidence of other airway diseases, such as chronic obstructive pulmonary disease. FUNDING: Sponsored by OPRI with partial funding by Circassia and study drugs provided by TEVA.

Hospital quality measures: are process indicators associated with hospital standardized mortality ratios in French acute care hospitals?

BACKGROUND: Results of associations between process and mortality indicators, both used for the external assessment of hospital care quality or public reporting, differ strongly across studies. However, most of those studies were conducted in North America or United Kingdom. Providing new evidence based on French data could fuel the international debate on quality of care indicators and help inform French policy-makers. The objective of our study was to explore whether optimal care delivery in French hospitals as assessed by their Hospital Process Indicators (HPIs) is associated with low Hospital Standardized Mortality Ratios (HSMRs). METHODS: The French National Authority for Health (HAS) routinely collects for each hospital located in France, a set of mandatory HPIs. Five HPIs were selected among the process indicators collected by the HAS in 2009. They were measured using random samples of 60 to 80 medical records from inpatients admitted between January 1st, 2009 and December 31, 2009 in respect with some selection criteria. HSMRs were estimated at 30, 60 and 90 days post-admission (dpa) using administrative health data extracted from the national health insurance information system (SNIIR-AM) which covers 77% of the French population. Associations between HPIs and HSMRs were assessed by Poisson regression models corrected for measurement errors with a simulation-extrapolation (SIMEX) method. RESULTS: Most associations studied were not statistically significant. Only two process indicators were found associated with HSMRs. Completeness and quality of anesthetic records was negatively associated with 30 dpa HSMR (0.72 [0.52-0.99]). Early detection of nutritional disorders was negatively associated with all HSMRs: 30 dpa HSMR (0.71 [0.54-0.95]), 60 dpa HSMR (0.51 [0.39-0.67]) and 90 dpa HSMR (0.52 [0.40-0.68]). CONCLUSION: In absence of gold standard of quality of care measurement, the limited number of associations suggested to drive in-depth improvements in order to better determine associations between process and mortality indicators. A smart utilization of both process and outcomes indicators is mandatory to capture aspects of the hospital quality of care complexity.

Epidemiology of sudden cardiac death in Cameroon: the first population-based cohort survey in sub-Saharan Africa.

Background: Incidence estimates of sudden cardiac death (SCD) in sub-Saharan Africa (SSA) are unknown. Method: Over 12 months, the household administrative office and health community committee within neighbourhoods in two health areas of Douala, Cameroon, registered all deaths among 86 188 inhabitants aged >18 years. As part of an extended multi-source surveillance system, the Emergency Medical Service (EMS), local medical examiners and district hospital mortuaries were also surveyed. Whereas two physicians investigated every natural death, two cardiologists reviewed all unexpected natural deaths. Results: There were 288 all-cause deaths and 27 (9.4%) were SCD. The crude incidence rate was 31.3 [95% confidence interval (CI): 20.3-40.6]/100 000 person-years. The age-standardized rate by the African standard population was 33.6 (95% CI: 22.4-44.9)/100 000 person-years. Death occurred at night in 37% of cases, including 11% of patients who died while asleep. Out-of-hospital sudden cardiac arrest occurred in 63% of cases, 55.5% of which occurred at home. Of the 88.9% cases of witnessed cardiac arrest, 63% occurred in the presence of a family member and cardiopulmonary resuscitation was attempted only in 3.7%. Conclusion: The burden of SCD in this African population is heavy with distinct characteristics, whereas awareness of SCD and prompt resuscitation efforts appear suboptimal. Larger epidemiological studies are required in SSA in order to implement preventive measures, especially in women and young people.

Inappropriate implantable cardioverter-defibrillator shocks in Brugada syndrome: Pattern in primary and secondary prevention.

BACKGROUND: Inappropriate implantable cardioverter-defibrillator (ICD) shocks is a common complication in Brugada syndrome. However, the incidence in recipients of ICD for primary and secondary prevention is unknown. METHOD AND RESULTS: We compared the rate of inappropriate shocks in patients with Brugada syndrome that had an ICD for primary and secondary prevention. We studied 51 patients, 86.5% of whom were males. Their mean age at diagnosis was 47 ± 11 years. Eighteen (35%) were asymptomatic, while 25 (49%) experienced syncope prior to implantation. Eight (16%) patients were resuscitated from ventricular fibrillation before implantation. During a mean follow-up of 78 ± 46 months, none of the asymptomatic patients experienced appropriate therapy, whereas 21.6% of symptomatic patients had ≥1 shock. Inappropriate shock occurred in 7 (13.7%) patients, with a mean IS of 6.57 ± 6.94 shocks per patient occurring 16.14 ± 10.38 months after implantation. There was a trend towards higher incidence of inappropriate shock in the asymptomatic group (p = 0.09). The interval from implantation to inappropriate shock occurrence was 13.91 ± 12.98 months. The risk of IS at 3 years was 13.7%, which eventually plateaued over the time. CONCLUSION: Inappropriate shock is common in Brugada syndrome during the early periods after an ICD implantation, and seems to be more likely in asymptomatic patients. This finding may warrant a review of the indications for ICD implantation, especially in the young and apparently healthy population of patients with Brugada syndrome.

Preterm Birth and Low Birth Weight after In Utero Exposure to Antiretrovirals Initiated during Pregnancy in Yaoundé, Cameroon.

BACKGROUND: Effects of antiretroviral therapy (ART) on birth outcomes remain controversial. OBJECTIVE: To assess the impact of antenatal exposure to ART on the occurrence of preterm birth (PTB) and low birth weight (LBW). METHODS: A cross-sectional study conducted at the Essos Hospital Center in Yaounde from 2008 to 2011 among HIV vertically exposed infants with two distinct maternal antiretroviral experiences: monotherapy group (Zidovudine, ZDV) and the combination ART group (cART). Mothers already receiving cART before pregnancy were ineligible. In both groups, events of PTB (<37 weeks) and LBW (<2,500g) were analyzed using univariate and multivariate logistic regression; with p<0.05 considered statistically significant. RESULTS: Of the 760 infants, 481 were born from cART-exposed mothers against 279 from maternal-ZDV. Median maternal CD4 count was 378 [interquartile range (IQR): 253-535] cells/mm3. Median duration of ART at onset of delivery was 13 [IQR: 10-17] weeks. In the cART-group, 64.9% (312/481) of mothers were exposed to Zidovudine/Lamuvidine/Nevirapine and only 2% (9/481) were on protease inhibitor-based regimens. Events of PTB were not significantly higher in the cART-group compared to the ZDV-group (10.2% vs. 6.4% respectively, p = 0.08), while onsets of LBW were significantly found in the cART-group compared to ZDV-group (11.6% vs. 7.2% respectively, p = 0.05). Other factors (parity, maternal age at delivery or CD4 cell count) were not associated with PTB. CONCLUSION: cART, initiated during pregnancy, would be an independent factor of LBW. In the era of option B+ (lifelong ART to all HIV-pregnant women), further studies would guide towards measures limiting onsets of LBW.

Hospital comparisons based on mortality: revisiting the choice of postadmission timeframe and evaluating the contribution of cause-of-death data, France, 2009.

BACKGROUND: In-hospital mortality is widely used to judge the quality of hospital care, but is biased by discharge patterns. Fixed-timeframe indicators have thus been recommended. However, the 30-day postadmission indicator may underestimate hospital-wide mortality, as patients dying in hospital >30 days after admission are considered as survivors. OBJECTIVES: To identify the most relevant timeframes and to assess the contribution of cause-of-death data. METHODS: The 2009 French hospital discharge database was linked to vital status records and to the causes of death register for 11.5 million hospital stays by beneficiaries of French general health insurance. Correlations and agreements between the 30-day hospital standardized mortality ratio (HSMR) and the in-hospital, 60-, 90-, 180-, and 365-day postadmission HSMRs were estimated. RESULTS: A total of 7.8%, 1.5%, and 0.5% of patients who died during their hospital stay were considered as survivors by the 30-, 60-, and 90-day HSMRs, respectively. The 30-day HSMR correlated strongly with the 60-day HSMR (Pearson coefficient=0.92), and their agreement on outlier status was excellent (κ coefficient=0.80). The association remained substantial at 90 days, but weakened at 180 days and even more so at 365 days. Regardless of the timeframe, exclusion of deaths likely due to independent causes barely modified the indicators. CONCLUSIONS: This nationwide study shows that 60- and 90-day HSMRs encompass in-hospital deaths better than the 30-day HSMR, while capturing the same interhospital variations. They should thus be preferred. The contribution of cause-of-death data to hospital-wide indicators seems negligible.