Variation In Patient Characteristics Research Articles

Laser-assisted hatching and clinical outcomes in frozen-thawed cleavage-embryo transfers of patients with previous repeated failure.

Assisted hatching (AH) is initially developed to provide an artificial manipulation of the zona pellucida (ZP) to help embryos hatch and improve the capacity of the embryos to implant. However, these effects remain unclear and controversial because of variation in patient characteristics, and it is critical to ascertain the indications for AH and to identify those patients who might benefit from AH. Here, this study aimed to assess the effect of laser-assisted zona thinning hatching technology (LAH) during the frozen-thawed D3 embryos on pregnancy outcomes in patients with previous repeated failures in vitro fertilization-embryo transfer (IVF-ET). To the best of our knowledge, these relationships have not been previously investigated. A retrospective cohort analysis was carried out. Infertility patients with previous repeated failure who underwent assisted reproductive therapy at our in vitro fertilization (IVF) center from May 2014 to May 2016 were enrolled. A total of 415 cleavage FET cycles (225 in the LAH group and 190 in the control group) were analyzed. Clinical outcomes including clinical pregnancy, implantation, live birth, miscarriage, and multiple gestation rates after transfer were compared between the LAH and control groups. The clinical pregnancy (49.3% versus 38.9%) and implantation rates (31.2% versus 24.6%) were significantly higher for the LAH group than the control group (P < 0.05). The live birth (44.8% versus 35.8%), multiple pregnancy (32.4% versus 31.0%), preterm birth (22.8% versus 17.1%), miscarriage (7.2% versus 5.4%), and ectopic rates (1.9% versus 0%) did not differ significantly between the two groups (P > 0.05). This study showed that LAH via zona pellucida (ZP) thinning significantly improves clinical outcomes, particularly clinical pregnancy and implantation rates, associated with FET cycles among patients with previous repeated failure.

Utilizing the Material Extrusion Additive Manufacturing Process to Fabricate an Overmoulding Solution for a Reconfigurable Thoracentesis Training Mannequin

Abstract Current thoracentesis medical training simulators lack tactile realism and do not represent the physiological variations in patient characteristics. This impedes optimal experiential learning. By systematically implementing advanced computer-aided design (CAD) techniques and additive manufacturing (AM) tools, thoracic wall representations for children to adults can be readily fabricated. Clavicular growth rates were used to scale the skeletal models for a wide range of patient demographics. Parametrically modelled mould sets enable the modification of tissue thickness to account for varying thoracic wall thicknesses. The fused deposition modeling (FDM) AM process was used to fabricate the skeletal structures, and complex overmoulding components. Using these advanced engineering tools allows solutions to be introduced quickly, with limited costs, compared to traditional methods.

Real-worldgeographic variations in the use of cardiac implantable electronic devices-The PANORAMA 2 observational cohort study.

Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs). In this prospective, multicenter, observational, multinational study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (Medtronic plc, Minneapolis, MN, USA; either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy -defibrillators, and 5.1% cardiac resynchronization therapy -pacemakers, from 117 hospitals in 23 countries across four geographical regions between 2012 and 2016. For all device types, in all regions, there were fewer females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women, and older patients were less likely to receive a magnetic resonance imaging-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF. We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials. We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations.

Factors associating with differences in the incidence of renal replacement therapy among elderly: data from the ERA-EDTA Registry.

The incidence of renal replacement therapy (RRT) in the general population ≥75years of age varies considerably between countries and regions in Europe. Our aim was to study characteristics and survival of elderly RRT patients and to find explanations for differences in RRT incidence. Patients ≥75years of age at the onset of RRT in 2010-2013 from 29 national or regional registries providing data to the European Renal Association-European Dialysis and Transplant Association Registry were included. Chi-square and Mann-Whitney U tests were used to assess variation in patient characteristics and linear regression was used to study the association between RRT incidence and various factors. Kaplan-Meier curves and Cox regression were employed for survival analyses. The mean annual incidence of RRT in the age group ≥75 years of age ranged from 157 to 924 per million age-related population. The median age at the start of RRT was higher and comorbidities were less common in areas with higher RRT incidence, but overall the association between patient characteristics and RRT incidence was weak. The unadjusted survival was lower in high-incidence areas due to an older age at onset of RRT, but the adjusted survival was similar [relative risk 1.00 (95% confidence interval, 0.97-1.03)] in patients from low- and high-incidence areas. Variation in the incidence of RRT among the elderly across European countries and regions is remarkable and could not be explained by the available data. However, the survival of patients in low- and high-incidence areas was remarkably similar.

Variations in Hospice Utilization and Length of Stay for Medicare Patients With Melanoma

ContextTimely hospice referral is an indicator of high-quality end-of-life care for cancer patients. Variations in patient characteristics associated with hospice utilization and length of stay have been demonstrated in studies of other malignancies but not melanoma. ObjectivesWe sought to understand hospice utilization and patient characteristics associated with variability in use for the older melanoma population. MethodsWe used the Surveillance, Epidemiology, and End Results–Medicare database to identify 13,393 melanoma patients aged 65+ years at time of diagnosis between 2000 and 2009, who died by 12/31/10. The primary outcome was enrollment in hospice with secondary outcome of hospice duration. Patient characteristics associated with variations in hospice enrollment were examined. ResultsAmong 13,393 patients who died with melanoma, 5298 (40%) received hospice care. Of these, 17% were enrolled in hospice for three days or less, while 13% had ≥90 days of hospice care. Despite improvements over time in the proportion of patients who received hospice and those who received at least 90 days of hospice care, late hospice enrollments did not change. Multivariable analysis revealed that patients of older age, with distant disease at time of diagnosis, and residing in rural areas or in census tracts with higher rates of high school completion were more likely to enroll in hospice. ConclusionRates of hospice enrollment increased over time but remained under accepted quality benchmarks with variations evident in those who receive hospice services. Efforts to increase access to earlier hospice care for all patients dying with melanoma are essential.

TCT-443 Geographical Variation in Patient Characteristics, Procedures and Clinical Outcomes after PCI of Left Main Coronary Artery Disease: Analysis from the EXCEL Trial

The international, randomized EXCEL trial reported similar 3-year rates of the primary endpoint of death, stroke or MI after PCI with everolimus-eluting stents vs. CABG in pts with left main coronary artery disease (LMCAD) and low or intermediate SYNTAX scores. Whether geographical differences in

Global geographical variation in patient characteristics in percutaneous coronary intervention clinical trials: A systematic review and meta-analysis

We sought to determine whether there are differences in enrolled patients' risk factors in published percutaneous coronary intervention (PCI) trials between various continents. We systematically identified clinical trials evaluating PCI interventions through PubMed. We reviewed 701 studies between 1990 and 2014 from North America (N=135), Europe (N=403), and Asia (N=163), examining the prevalence of cardiovascular risk factors-hypertension (HTN), diabetes mellitus (DM), hyperlipidemia (HL), smoking, sex, and body mass index. We performed meta-regression with random- and mixed-effects models to compare patient baseline characteristics between continents and linear meta-regression analysis to test trends over time. In meta-regression with random-effects model, North American trials recruited the lowest proportion of male participants (71.32%), followed by Asian (74.41%) and European trials (76.47%; P<.0001). North American trials enrolled the highest proportion of patients with HTN (63.17%, P=.0035) and HL (63.72%, P<.0001), whereas Asia enrolled the highest proportion of DM patients (29.64%, P<.0001) and smoking (38.41%, P=.0144). When adjusting for other moderators such as publication date, body mass index, and sex in meta-regression with mixed-effects model, age was significantly positively correlated with HTN, HL, DM, and smoking (P<.001). Body mass index was significantly higher in Europe and North America than in Asia. All enrollment risk factors demonstrated (β<0.02) statistically significant temporal trends over time, except for sex. There are major continental differences in risk factors among patients enrolled in PCI trials from various continents. Clinical trial results may not be applicable to patient populations from another region.

Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data.

Screening for cancer in patients with unprovoked venous thromboembolism (VTE) often is considered, but clinicians need precise data on cancer prevalence, risk factors, and the effect of different types of screening strategies. To estimate the prevalence of occult cancer in patients with unprovoked VTE, including in subgroups of different ages or those that have had different types of screening. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to 19 January 2016. Prospective studies evaluating cancer screening strategies in adults with unprovoked VTE that began enrolling patients after 1 January 2000 and had at least 12 months of follow-up. 2 investigators independently reviewed abstracts and full-text articles and independently assessed risk of bias. 10 eligible studies were identified. Individual data were obtained for all 2316 patients. Mean age was 60 years; 58% of patients received extensive screening. The 12-month period prevalence of cancer after VTE diagnosis was 5.2% (95% CI, 4.1% to 6.5%). The point prevalence of cancer was higher in patients who had extensive screening than in those who had more limited screening initially (odds ratio [OR], 2.0 [CI, 1.2 to 3.4]) but not at 12 months (OR, 1.4 [CI, 0.89 to 2.1]). Cancer prevalence increased linearly with age and was 7-fold higher in patients aged 50 years or older than in younger patients (OR, 7.1 [CI, 3.1 to 16]). Variation in patient characteristics and extensive screening strategies; unavailability of long-term mortality data. Occult cancer is detected in 1 in 20 patients within a year of receiving a diagnosis of unprovoked VTE. Older age is associated with a higher cancer prevalence. Although an extensive screening strategy initially may detect more cancer cases than limited screening, whether this translates into improved patient outcomes remains unclear. None. (PROSPERO: CRD42016033371).

Hospital variation in allogeneic transfusion and extended length of stay in primary elective hip and knee arthroplasty: a cross-sectional study

ObjectivesOutcomes in total hip and knee arthroplasty (THA and TKA), such as allogeneic transfusions or extended length of stay (LoS), can be used to compare the performance of hospitals. However,...

Seasonal variation in patient characteristics and in-hospital outcomes of Takotsubo syndrome: a nationwide retrospective cohort study in Japan

Although there is reportedly seasonal variation in the occurrence of Takotsubo syndrome (TTS), it is unknown whether there is a relationship between season and patient characteristics, or whether season influences outcomes. Using the Diagnosis Procedure Combination database in Japan, we retrospectively identified 4306 patients (mean age 73.6years) hospitalized with TTS between January 2011 and December 2013. We divided patients into four groups according to season of admission [n=914, Spring (March-May); n=1243, Summer (June-August); n=1245, Autumn (September-November); n=904, Winter (December-February)]. The outcomes were in-hospital mortality and cardiovascular complications. We compared patient backgrounds and outcomes across seasons and estimated the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for outcomes in logistic regression analyses adjusted for multiple propensity scores. Although there was no significant difference in age across seasons, the proportion of males differed significantly (from 18.5% in autumn to 23.9% in winter; p=0.016). The incidence of psychiatric disease (from 4.9% in spring to 7.9% in summer; p=0.025) and sepsis (from 0.8% in winter to 2.6% in summer; p=0.019) also differed significantly with season. In-hospital mortality was not significantly influenced by season (p=0.377): spring, 5.1%; summer, 6.0%; autumn, 4.6%; winter, 6.0%. However, in-hospital mortality ranged widely across months from 3.0% in September to 7.5% in April. The incidence of ventricular tachycardia/fibrillation was significantly different (p=0.038): spring, 2.2% (reference); summer, 3.3% (aOR 1.46, 95% CI 0.84-2.51); autumn, 2.7% (aOR 1.27, 95% CI 0.72-2.22); winter, 4.4% (aOR 1.92, 95% CI 1.11-3.33). Although season did not appear to influence the in-hospital mortality of TTS, monthly variation may exist in the risk of death in patients with TTS. There were significant seasonal variations in the proportions of males, patients with psychiatric disease or sepsis, and the incidence of ventricular arrhythmias among patients with TTS.

Low Back Pain: Investigation of Biases in Outpatient Canadian Physical Therapy.

Previous research suggested that physical therapy services can be influenced by patient characteristics (age, sex, socioeconomic status) or insurance status rather than their clinical need. The aim of this study was to determine whether patient-related factors (age, sex, SES) and the source of reimbursement for physical therapy services (insurance status) influence wait time for, frequency of, and duration of physical therapy for low back pain. This study was an empirical cross-sectional online survey of Canadian physical therapy professionals (defined as including physical therapists and physical rehabilitation specialists). A total of 846 physical therapy professionals received 1 of 24 different (and randomly selected) clinical vignettes (ie, patient case scenarios) and completed a 40-item questionnaire about how they would treat the fictional patient in the vignette as well as their professional clinical practice. Each vignette described a patient with low back pain but with variations in patient characteristics (age, sex, socioeconomic status) and insurance status (no insurance, private insurance, Workers' Compensation Board insurance). The age, sex, and socioeconomic status of the fictional vignette patients did not affect how participants would provide service. However, vignette patients with Workers' Compensation Board insurance would be seen more frequently than those with private insurance or no insurance. When asked explicitly, study participants stated that insurance status, age, and chronicity of the condition were not factors associated with wait time for, frequency of, or duration of treatment. This study used a standardized vignette patient and may not accurately represent physical therapy professionals' actual clinical practice. There appears to be an implicit professional bias in relation to patients' insurance status; the resulting inequity in service provision highlights the need for further research as a basis for national guidelines to promote equity in access to and provision of quality physical therapy services.

Spectrum of renal biopsy finding in idiopathic nephrotic syndrome in children: An 18-month retrospective analysis at a tertiary care pediatric nephrology center in North Karnataka, India

Context: Idiopathic nephrotic syndrome (NS) is the most common glomerular nephropathy in pediatrics, with great variation in patient characteristics in different regions of the world. Difficult childhood NS poses a great diagnostic and management challenge for the treating nephrologists. The histopathological features of NS have been extensively studied by various authors from different regions of the world with a wide variation in the histopathological distribution. We aimed to describe the spectrum of histopathological diagnosis in childhood NS from North Karnataka, India, where there is a high incidence of consanguinity. Aims: The aim of this study is to study the spectrum of histopathology in children who underwent a renal biopsy in our tertiary care pediatric nephrology center. Settings and Design: Retrospective observational study at a tertiary care pediatric nephrology center over 1 year from January 2013 to June 2015. Subjects and Methods: The medical records of all children diagnosed as NS were retrospectively reviewed for demographic data, clinical course, and histopathological diagnosis. Statistical Analysis Used: Descriptive statistics. Results: Twenty-five children underwent biopsy in the study period. Seventeen (68%) were male as compared to 8 (32%) females. Thirteen (52%) of biopsied patients showed minimal change NS, 6 (24%) had focal segmental glomerulosclerosis, and 3 (14%) patients showed IgA nephropathy while 1 patient had mesangioproliferative glomerulonephritis, IgM nephropathy, and Finnish type NS each. Conclusions: Minimal change nephritic syndrome is the major biopsy finding in our part of the country even in steroid-resistant NS. This finding needs to be confirmed with studies with bigger sample size.

Children and Young Adults Who Received Tracheostomies or Were Initiated on Long-Term Ventilation in PICUs.

To characterize patients who received tracheostomies for airway compromise or were initiated on long-term ventilation for chronic respiratory failure in PICUs and to examine variation in the incidence of initiation, patient characteristics, and modalities across sites. Retrospective cross-sectional analysis. Seventy-three North American PICUs that participated in the Virtual Pediatric Systems, LLC. PICU patients admitted between 2009 and 2011. None. Among 115,437 PICU patients, 1.8% received a tracheostomy or were initiated on long-term ventilation; 1,034 received a tracheostomy only, 717 were initiated on invasive ventilation, and 381 were initiated on noninvasive ventilation. Ninety percent had substantial chronic conditions and comorbidities, including more than 50% with moderate or worse cerebral disability upon discharge. Seven percent were initiated after a catastrophic injury/event. Across sites, there was variation in incidence of tracheotomy and initiation of long-term ventilation, ranging from 0% to 4.6%. There also was variation in patient characteristics, time to tracheotomy, number of extubations prior to tracheostomy, and the use of invasive ventilation versus noninvasive ventilation. Although the PICU incidence of initiation of tracheostomies and long-term ventilation was relatively uncommon, it suggests that thousands of children and young adults receive these interventions each year in North American PICUs. The majority of them have conditions and comorbidities that impose on-going care needs, beyond those required by artificial airways and long-term ventilation themselves.

Geographic variations in the PARADIGM-HF heart failure trial.

AimsThe globalization of clinical trials has highlighted geographic variations in patient characteristics, event rates, and treatment effects. We investigated these further in PARADIGM-HF, the largest and most globally representative trial in heart failure (HF) to date.Methods and resultsWe looked at five regions: North America (NA) 602 (8%), Western Europe (WE) 1680 (20%), Central/Eastern Europe/Russia (CEER) 2762 (33%), Latin America (LA) 1433 (17%), and Asia-Pacific (AP) 1487 (18%). Notable differences included: WE patients (mean age 68 years) and NA (65 years) were older than AP (58 years) and LA (63 years) and had more coronary disease; NA and CEER patients had the worst signs, symptoms, and functional status. North American patients were the most likely to have a defibrillating-device (54 vs. 2% AP) and least likely prescribed a mineralocorticoid receptor antagonist (36 vs. 65% LA). Other evidence-based therapies were used most frequently in NA and WE. Rates of the primary composite outcome of cardiovascular (CV) death or HF hospitalization (per 100 patient-years) varied among regions: NA 13.6 (95% CI 11.7–15.7) WE 9.6 (8.6–10.6), CEER 12.3 (11.4–13.2), LA 11.2 (10.0–12.5), and AP 12.5 (11.3–13.8). After adjustment for prognostic variables, relative to NA, the risk of CV death was higher in LA and AP and the risk of HF hospitalization lower in WE. The benefit of sacubitril/valsartan was consistent across regions.ConclusionThere were many regional differences in PARADIGM-HF, including in age, symptoms, comorbidity, background therapy, and event-rates, although these did not modify the benefit of sacubitril/valsartan.Clinical trial registration URL http://www.clinicaltrials.gov. Unique identifier: NCT01035255.

High-Cost Users of Prescription Drugs: A Population-Based Analysis from British Columbia, Canada.

ObjectiveTo examine variation in pharmaceutical spending and patient characteristics across prescription drug user groups.Data SourcesBritish Columbia's population‐based linked administrative health and sociodemographic databases (N = 3,460,763).Study DesignWe classified individuals into empirically derived prescription drug user groups based on pharmaceutical spending patterns outside hospitals from 2007 to 2011. We examined variation in patient characteristics, mortality, and health services usage and applied hierarchical clustering to determine patterns of concurrent drug use identifying high‐cost patients.Principal FindingsApproximately 1 in 20 British Columbians had persistently high prescription costs for 5 consecutive years, accounting for 42 percent of 2011 province‐wide pharmaceutical spending. Less than 1 percent of the population experienced discrete episodes of high prescription costs; an additional 2.8 percent transitioned to or from high‐cost episodes of unknown duration. Persistent high‐cost users were more likely to concurrently use multiple chronic medications; episodic and transitory users spent more on specialized medicines, including outpatient cancer drugs. Cluster analyses revealed heterogeneity in concurrent medicine use within high‐cost groups.ConclusionsWhether low, moderate, or high, costs of prescription drugs for most individuals are persistent over time. Policies controlling high‐cost use should focus on reducing polypharmacy and encouraging price competition in drug classes used by ordinary and high‐cost users alike.

Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure.

Substantial attention and resources have been directed to improving outcomes of patients with critical illnesses, in particular sepsis, but all recent clinical trials testing various interventions or strategies have failed to detect a robust benefit on mortality. Acute heart failure is also a critical illness, and although the underlying etiologies differ, acute heart failure and sepsis are critical care illnesses that have a high mortality in which clinical trials have been difficult to conduct and have not yielded effective treatments. Both conditions represent a syndrome that is often difficult to define with a wide variation in patient characteristics, presentation, and standard management across institutions. Referring to past experiences and lessons learned in acute heart failure may be informative and help frame research in the area of sepsis. Academic heart failure investigators and industry have worked closely with regulators for many years to transition acute heart failure trials away from relying on dyspnea assessments and all-cause mortality as the primary measures of efficacy, and recent trials have been designed to assess novel clinical composite endpoints assessing organ dysfunction and mortality while still assessing all-cause mortality as a separate measure of safety. Applying the lessons learned in acute heart failure trials to severe sepsis and septic shock trials might be useful to advance the field. Novel endpoints beyond all-cause mortality should be considered for future sepsis trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s40560-016-0151-6) contains supplementary material, which is available to authorized users.

Personalized treatment planning with a model of radiation therapy outcomes for use in multiobjective optimization of IMRT plans for prostate cancer.

PurposeTo build a new treatment planning approach that extends beyond radiation transport and IMRT optimization by modeling the radiation therapy process and prognostic indicators for more outcome-focused decision making.MethodsAn in-house treatment planning system was modified to include multiobjective inverse planning, a probabilistic outcome model, and a multi-attribute decision aid. A genetic algorithm generated a set of plans embodying trade-offs between the separate objectives. An influence diagram network modeled the radiation therapy process of prostate cancer using expert opinion, results of clinical trials, and published research. A Markov model calculated a quality adjusted life expectancy (QALE), which was the endpoint for ranking plans.ResultsThe Multiobjective Evolutionary Algorithm (MOEA) was designed to produce an approximation of the Pareto Front representing optimal tradeoffs for IMRT plans. Prognostic information from the dosimetrics of the plans, and from patient-specific clinical variables were combined by the influence diagram. QALEs were calculated for each plan for each set of patient characteristics. Sensitivity analyses were conducted to explore changes in outcomes for variations in patient characteristics and dosimetric variables. The model calculated life expectancies that were in agreement with an independent clinical study.ConclusionsThe radiation therapy model proposed has integrated a number of different physical, biological and clinical models into a more comprehensive model. It illustrates a number of the critical aspects of treatment planning that can be improved and represents a more detailed description of the therapy process. A Markov model was implemented to provide a stronger connection between dosimetric variables and clinical outcomes and could provide a practical, quantitative method for making difficult clinical decisions.

Individual analysis of patients with HoFH participating in a phase 3 trial with lomitapide: The Italian cohort

Background and aimsThe efficacy and safety of lomitapide as adjunct treatment for adults with homozygous familial hypercholesterolaemia (HoFH) have been confirmed in a phase 3 trial. Given the small number of patients (N = 29), and variations in patient characteristics, examining individual cases provides additional details regarding patient management with lomitapide. Here, we examine the details of the Italian patient cohort in the phase 3 trial. Methods and resultsThe methodology of the multinational, single-arm, open-label, 78-week, dose-escalation, phase 3 trial has been previously reported. The current report details the Italian cohort of six patients (three males, three females) based on individual patient data, individual patient histories and narratives, and by mean data ± SD.Lomitapide was administered according to the dose-escalation protocol. At Week 78, concentrations of low-density lipoprotein-cholesterol were decreased by a mean of 42.6 ± 21.8% compared with baseline. Lomitapide was similarly well tolerated in the Italian cohort as in the entire study population. The most common adverse events were gastrointestinal symptoms. One patient showed an increase in liver transaminases >5× upper limit of normal that resolved after lomitapide treatment was reduced and maintained at a lower dose. ConclusionThe efficacy, safety and tolerability of lomitapide demonstrated in the Italian subgroup of patients are consistent with findings in the entire study population, and illustrate the broad applicability of lomitapide therapy across genotypes and clinical phenotypes. These data also provide an insight into the management of lomitapide use in a cohort of patients within a clinical trial protocol.Clinicaltrials.gov Identifier: NCT00730236.

Variation in Patient Characteristics and Outcomes Between Early and Delayed Surgery in Poor-Grade Aneurysmal Subarachnoid Hemorrhage.

There is no consensus regarding the optimal timing for surgery for poor-grade aneurysmal subarachnoid hemorrhage. To retrospectively evaluate variation in patient characteristics and outcomes between early and delayed surgery groups. Poor-grade aneurysmal subarachnoid hemorrhage was defined as a World Federation of Neurosurgical Societies grade of IV or V after resuscitation. Early surgery was defined as surgery performed within 72 hours of ictus, and delayed surgery was defined as surgery after 72 hours. Outcomes were assessed by modified Rankin score. The mean time of follow-up was 12.5 ± 3.4 months. Of the 118 patients included in the study, 80 (68%) underwent early surgery and 38 (32%) underwent delayed surgery. Patients with brain herniation (P < .001) and a lower Fisher grade (P = .02) more often underwent early surgery. Patients in the early group more often underwent decompressive craniectomy (P < .001). Postoperative complications and length of hospital stay did not differ, and outcomes were similar between the 2 groups. Forty (34%) patients had an excellent outcome (modified Rankin score 0-1). Multivariate analysis showed a slight trend toward an excellent outcome in the early surgery group. Younger age, World Federation of Neurosurgical Societies grade IV after resuscitation, and middle cerebral artery aneurysms were independent predictors of an excellent outcome. Although patients with brain herniation and a lower Fisher grade were more likely to undergo early surgery, there was a slight trend toward an excellent outcome in the early surgery group. Patients with a younger age, World Federation of Neurosurgical Societies grade IV after resuscitation, and middle cerebral artery aneurysms were more likely to experience an excellent outcome.

Integration of TB-HIV services at an ANC facility in Frances Baard District, Northern Cape, South Africa.

Integrated tuberculosis-human immunodeficiency virus (TB-HIV) service delivery as part of maternal health services, including antenatal care (ANC), is widely recommended. This study assessed the implementation of collaborative TB-HIV service delivery at a hospital-based ANC service unit. A record review of a random sample of 308 pregnant women attending the ANC service between April 2011 and February 2012 was conducted. Data were extracted from registers and patient case notes. Outcomes included the proportion of women who underwent HIV counselling and testing (HCT), CD4 count testing, antiretroviral treatment (ART), cotrimoxazole preventive treatment (CPT), TB screening and isoniazid preventive treatment (IPT). Analysis measured variations in patient characteristics associated with service delivery. All women underwent HCT; 80% of those who tested HIV-positive were screened for TB. Most (85.9%) of the HIV-positive women received a CD4 count. However, only 12.9% of eligible women received ART prophylaxis onsite, only 35.7% were referred for initiation of ART, only 42.3% commenced IPT and none received CPT or further investigations for TB. HIV-negative women had 2.6 higher odds (95%CI 1.3-5.3) of receiving TB screening than their HIV-positive counterparts. Although the identification of HIV-positive women and TB suspects was adequate, implementation of other TB-HIV collaborative activities was sub-optimal.