Dysglycemia and incident heart failure among blacks: The jackson heart study.

BACKGROUND: We aimed to investigate the associations of glycemic markers (hemoglobin A1C [HbA1C], fasting plasma glucose [FPG] and glycemic status [normoglycemia, prediabetes and diabetes]) with incident heart failure (HF) and its subtypes, among Blacks. METHODS: We included 2,290 community-dwelling Blacks (64% women, mean age 58 years) without prevalent HF from the Jackson Heart Study who attended the second exam (2005 - 2008). The associations between glycemic markers and incident HF (and subtypes including HF with preserved ejection fraction [HFpEF] and reduced ejection fraction [HFrEF]) were evaluated using Cox proportional hazards regression models, adjusting for risk factors and coronary heart disease. RESULTS: There were 119 incident HF events (48 HFpEF, 58 HFrEF, and 13 unclassified HF events) over a median follow-up of 10.5 years. Higher levels of HbA1C (HR per SD increment, 1.30; 95% CI 1.12, 1.51) and FPG (HR per SD increment FPG: 1.32; 95% CI: 1.17, 1.48) were associated with a higher risk of incident HF. Compared to normal glycemia, diabetes status was associated with a higher risk of incident HF (HR: 1.24; 95%CI: 1.02, 2.05). HbA1C was significantly associated with higher risks of HFpEF (HR per SD increment: 1.41, 95% CI: 1.18, 1.69) and HFrEF (HR per SD increment: 1.32; 95% CI: 1.12, 1.56). FPG was significantly associated with higher risk of HFpEF (HR per SD increment: 1.35, 95% CI: 1.14, 1.62) but not HFrEF (HR per SD increment: 1.12; 95% CI: 0.53, 2.35). CONCLUSIONS: Among community-dwelling Blacks, higher levels of glycemic markers were associated with higher risk of HF subtypes.

Ambulatory Blood Pressure Phenotypes in Adults Taking Antihypertensive Medication with and without CKD.

BACKGROUND AND OBJECTIVES: Recent guidelines recommend out-of-clinic BP measurements. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We compared the prevalence of BP phenotypes between 561 black patients, with and without CKD, taking antihypertensive medication who underwent ambulatory BP monitoring at baseline (between 2000 and 2004) in the Jackson Heart Study. CKD was defined as an albumin-to-creatinine ratio ≥30 mg/g or eGFR <60 ml/min per 1.73 m2. Sustained controlled BP was defined by BP at goal both inside and outside of the clinic and sustained uncontrolled BP as BP above goal both inside and outside of the clinic. Masked uncontrolled hypertension was defined by controlled clinic-measured BP with uncontrolled out-of-clinic BP. RESULTS: CKD was associated with a higher multivariable-adjusted prevalence ratio for uncontrolled versus controlled clinic BP (prevalence ratio, 1.44; 95% CI, 1.02 to 2.02) and sustained uncontrolled BP versus sustained controlled BP (prevalence ratio, 1.66; 95% CI, 1.16 to 2.36). There were no statistically significant differences in the prevalence of uncontrolled daytime or nighttime BP, nondipping BP, white-coat effect, and masked uncontrolled hypertension between participants with and without CKD after multivariable adjustment. After multivariable adjustment, reduced eGFR was associated with masked uncontrolled hypertension versus sustained controlled BP (prevalence ratio, 1.42; 95% CI, 1.00 to 2.00), whereas albuminuria was associated with uncontrolled clinic BP (prevalence ratio, 1.76; 95% CI, 1.20 to 2.60) and sustained uncontrolled BP versus sustained controlled BP (prevalence ratio, 2.02; 95% CI, 1.36 to 2.99). CONCLUSIONS: The prevalence of BP phenotypes defined using ambulatory BP monitoring is high among adults with CKD taking antihypertensive medication.

Dietary Phosphorus and Ambulatory Blood Pressure in African Americans: The Jackson Heart Study.

BACKGROUND: Higher dietary phosphorus is associated with left ventricular hypertrophy and mortality, which are blood pressure (BP)-related outcomes. For this reason, we hypothesized that dietary phosphorus may be associated with adverse clinic and ambulatory BP patterns. METHODS: Our study included 973 African American adults enrolled in the Jackson Heart Study (2000-2004) with 24-hour ambulatory BP monitoring (ABPM) data at baseline. We quantified dietary phosphorus from a validated Food Frequency Questionnaire as follows: (i) absolute daily intake, (ii) ratio of phosphorus-to-protein intake, (iii) phosphorus density, and (iv) energy-adjusted phosphorus intake. Using multivariable linear regression, we determined associations between dietary phosphorus intake and systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure in clinic and over daytime, nighttime, and 24-hour periods from ABPM. Extent of nocturnal BP dipping was also assessed. Using logistic regression, we modeled relationships between dietary phosphorus intake and clinically relevant qualitative BP phenotypes, such as masked, sustained, or white-coat hypertension and normotension. RESULTS: There were no statistically significant associations between phosphorus intake and SBP or pulse pressure in adjusted models. Most metrics of higher phosphorus intake were associated with lower daytime, nighttime, and clinic DBP. Higher phosphorus intake was not associated with clinic or ABPM-defined hypertension overall, but most metrics of higher phosphorus intake were associated with lower odds of sustained hypertension compared to sustained normotension, white-coat hypertension, and masked hypertension. There were no associations between dietary phosphorus and nocturnal BP dipping. CONCLUSIONS: These data do not support a role for higher phosphorus intake and higher BP in African Americans.

Relation of multi-marker panel to incident chronic kidney disease and rapid kidney function decline in African Americans: the Jackson Heart Study.

BACKGROUND: Few investigations have evaluated the incremental usefulness of multiple biomarkers representing varying physiological pathways for predicting risk of renal outcomes in African Americans. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: We related a multi-marker panel to incident chronic kidney disease (CKD) and rapid kidney function decline (RKFD) in 2813 Jackson Heart Study participants without prevalent CKD at exam 1 (2000-2004) and with complete assays at exam 1 for 9 biomarkers: adiponectin, aldosterone, B-natriuretic peptide [BNP], cortisol, high sensitivity C-reactive protein (hsCRP), endothelin, homocysteine, plasma renin activity and mass. Incident CKD was defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 at exam 3 while RKFD was defined as eGFR ≥30% loss between exams 1 and 3 (8.2 median years). We employed multiple logistic regression model to describe association between the panel and incident CKD and RKFD and used backward elimination strategy to estimate the most parsimonious biomarker model while controlling for conventional risk factors. RESULTS: The multi-marker panel predicted the risk for both incident CKD (odds ratios [OR], 2.72; 95% confidence intervals [CI], 1.63, 4.56; P = 0.001) and RKFD (2.61; 95% CI, 1.67, 4.08; P < 0.001). Per standard deviation increase in log biomarker concentrations were significantly (multivariable adjusted odds ratios, [95% confidence interval], p-value) associated with incident CKD: plasma adiponectin (1.24 [1.07, 1.44], p = 0.005) and leptin (1.3 [1.06, 1.61], p = 0.011), and with RKFD: plasma adiponectin (1.22 [1.06, 1.40], p = 0.006); hsCRP (1.17 [1.01, 1.36], p = 0.031) and aldosterone (0.85 [0.74, 0.96], p = 0.012). Moderate levels (3rd quartile) of aldosterone were inversely associated with incident CKD (0.54 [0.35, 0.82], p = 0.004) while leptin was associated with RKFD (1.64 [1.10, 2.44], p = 0.015). Biomarkers improved CKD risk prediction (P = 0.003) but not RKFD risk prediction (P = 0.10). CONCLUSION: In this community-based sample of African Americans, a multi-marker panel added only moderate predictive improvement compared to conventional risk factors.

Relation of uric acid level to rapid kidney function decline and development of kidney disease: The Jackson Heart Study.

Whether elevated uric acid (UA) is an independent risk factor for chronic kidney disease (CKD) is not well established. The authors evaluated the relationship of UA with rapid kidney function decline (RKFD) and incident CKD among 3702 African Americans (AAs) in the Jackson Heart Study with serum UA levels measured at baseline exam (2000-2004). RKFD was defined as ≥ 30% eGFR loss and incident CKD as development of eGFR < 60 mL/min/1.73 m2 with a ≥ 25% decline in eGFR between baseline and exam 3 (2009-2013). RKFD and CKD were found in 11.4% and 7.5% of the participants, respectively. In a fully adjusted model, the odds of RKFD (OR, 1.8; 95% CI, 1.25-2.49) and incident CKD (OR, 2.00; 95% CI, 1.31-3.06) were significantly higher among participants in the top UA quartile vs bottom quartile. In the JHS, elevated UA was significantly associated with RKFD and incident CKD.

Obesity and synergistic risk factors for chronic kidney disease in African American adults: the Jackson Heart Study.

Background: African Americans are at high risk for chronic kidney disease (CKD). Obesity may increase the risk for CKD by exacerbating features of the metabolic syndrome and promoting glomerular hyperfiltration. Whether other factors also affecting these pathways may amplify or mitigate obesity-CKD associations has not been investigated. Methods: We studied interactions between obesity and these candidate factors in 2043 African Americans without baseline kidney disease enrolled in the Jackson Heart Study. We quantified obesity as body mass index (BMI), sex-normalized waist circumference and visceral adipose volume measured by abdominal computed tomography at an interim study visit. Interactions were hypothesized with (i) metabolic risk factors (dietary quality and physical activity, both quantified by concordance with American Heart Association guidelines) and (ii) factors exacerbating or mitigating hyperfiltration (dietary protein intake, APOL1 risk status and use of renin-angiotensin system blocking medications). Using multivariable regression, we evaluated associations between obesity measures and incident CKD over the follow-up period, as well as interactions with metabolic and hyperfiltration factors. Results: Assessed after a median of 8 years (range 6-11 years), baseline BMI and waist circumference were not associated with incident CKD. Higher visceral adipose volume was independently associated with incident CKD (P = 0.008) in a nonlinear fashion, but this effect was limited to those with lower dietary quality (P = 0.001; P-interaction = 0.04). In additional interaction models, higher waist circumference was associated with greater risk of incident CKD among those with the low-risk APOL1 genotype (P = 0.04) but not those with a high-risk genotype (P-interaction = 0.02). Other proposed factors did not modify obesity-CKD associations. Conclusions. Higher risks associated with metabolically active visceral adipose volume and interactions with dietary quality suggest that metabolic factors may be key determinants of obesity-associated CKD risk. Interactions between obesity and APOL1 genotype should be considered in studies of African Americans.

Comparison of two classification systems for vesicovaginal fistula.

INTRODUCTION AND HYPOTHESIS: This study aims to compare the prognostic value of two obstetric fistula classification systems. METHODS: Prospective analysis of 202 patients evaluated for obstetric fistula (OF) at the General Referral Hospital of Panzi, Bukavu, DRC, from April through December 2009. Fistula classification using both Goh's and Waaldijk's systems, as well as preoperative, surgical, and follow-up assessment were included. Receiver operating characteristics (ROC) curves were used to compare the accuracy of the two systems to discriminate successful closure from persistent fistula. RESULTS: Two hundred two women underwent fistula repair. Ten were lost to follow-up. At longest follow-up, 181 patients (88.3%) had successful fistula closure. On multivariate analysis, the independent variables of multiparity and a primary or secondary repair were more likely to have a successful closure. In Waaldijk's system, no single component was more predictive of successful closure than another. In Goh's system, type 4 fistulae were more likely to have failed closure compared to those with type 1 or 2 (p = 0.0144). When comparing ROC curves, Goh's system had significantly better ability to predict successful closure than the Waaldijk's system, p = 0.0421. CONCLUSIONS: Waaldijk and Goh are the two most commonly used obstetric fistula classification systems. In this series of OF patients at Panzi Hospital in the Democratic Republic of Congo, Goh's classification system demonstrated a significantly better prediction of OF closure than the Waaldijk's system.

Traditional native tissue versus mesh-augmented pelvic organ prolapse repairs: providing an accurate interpretation of current literature.

The objective of this paper was to review the literature on pelvic organ prolapse (POP) and compare the success of traditional/native tissue versus mesh-augmented repairs. A comprehensive literature review was performed using PubMed and bibliography searches to compare the anatomic success rates of native tissue (NT) and mesh-augmented (MA) prolapse repairs and to analyze outcome measures used to report success rates. Articles were included if anatomic outcomes were stated for the specific compartment of interest and included both prospective and retrospective studies. The published success rates for NT repairs versus MA repairs by anterior, posterior, or apical compartments are reported. When continence is used as the primary outcome measure, anterior NT has a success rate of 54%. Anterior NT success is as low as 30% in some studies, but generally is 88-97% when prolapse is the primary outcome particularly if apical support is included. This compares to the 87-96% success reported for anterior MA. Posterior NT success is 54-81%, which is lower than the 92-97% reported for posterior MA when prolapse is the outcome measure. The success rates for apical NT are 97-98% for uterosacral ligament suspension and 96% for sacrospinous ligament suspension, which compare favorably to sacrocolpopexy (91-100%). There are some differences in the complications reported for NT and MA. The rate of complications is approximately 8% for NT and is reported at 0-19% for MA. The higher rate for MA is largely due to mesh erosion/exposure. When similar outcome measures are compared, the published anatomic success rates of POP of anterior and apical compartmental surgery are similar for NT and MA repairs. There may be a higher rate of complications noted for mesh implantation. POP surgery is complex, and both NT and MA techniques require skills to perform proper compartmental reconstruction. An understanding of the published literature and knowledge of individual surgeon factors are important in deciding which surgical approach to use and how to best counsel patients during informed consent.

Outcomes and complications of transvaginal and abdominal custom-shaped light-weight polypropylene mesh used in repair of pelvic organ prolapse.

STUDY OBJECTIVE: To assess the outcomes and complications of transvaginally placed custom-shaped light-weight polypropylene mesh for repair of pelvic organ prolapse. DESIGN: Retrospective review of medical records (Canadian Task Force classification II-2). SETTING: Two urogynecologic centers. PATIENTS: Between March 2006 and September 2007, 154 women with anterior, posterior, or apical prolapse underwent vaginal reconstructive surgery using custom-shaped transvaginal or abdominal mesh. Surgical procedures were chosen after informed consent. The primary outcome for the study was recurrence of prolapse, defined as POP-Q (Pelvic Organ Prolapse Quantitative) stage II or greater. Secondary end points included perioperative and postoperative complications. INTERVENTIONS: Anterior compartment repair was performed in 94 patients (61%), and posterior compartment repair in 60 (39%). Combined anterior and posterior repairs were performed in 25 patients. Hysterectomy was performed in 27 patients (18%) (abdominal in 1, vaginal in 19, and laparoscopy-assisted in 7). Apical support techniques included sacrospinous fixation in 69 patients (45%), abdominal sacral colpopexy in 30 (19%), and vaginal culdoplasty in 7 (5%). Transobturator sling procedures were performed in 65 patients (42%). MEASUREMENTS AND MAIN RESULTS: Postoperative follow-up exceeded 24 months in all patients. The overall success of these procedures was 97.4%. There were 4 failures (2.6%), defined as stage II prolapse or greater. Comparison of POP-Q points Aa, Ba, C, Ap, and Bp preoperatively and postoperatively revealed statistically significant improvement at each point (p <.001). Complications were observed in 17 patients (11%), with mesh extrusion in 1 (0.7%). CONCLUSIONS: Long-term follow-up demonstrated that use of custom-shaped light-weight polypropylene mesh is safe and effective, with a low rate of complications.

Hemodynamic performance of mitroflow aortic pericardial bioprosthesis - optimizing management for the small aortic annulus.

BACKGROUND: Documentation of the hemodynamics of the Mitroflow aortic pericardial bioprosthesis has been incomplete. The aim of the study was to provide reference effective orifice areas for the implant calculation of effective orifice area indexes to avoid prosthesis-patient mismatch. METHODS: Echocardiograms were evaluated in 55 patients (39 females, 16 males), mean age 77.0 +/- 6.9 years (range 51-90 years). The mean time of the studies was 11.0 months. The prosthesis sizes and numbers evaluated were 19 mm (n = 13), 21 mm (n = 19), 23 mm (n = 13) and 25 mm (n = 10). RESULTS: Peak aortic velocities averaged from 2.2 to 2.7 m/sec, mean gradients from 10.6 to 15.1 mmHg, peak gradients from 20.7 to 29.7 mmHg, and effective orifice area (EOA) from 1.4 to 1.8 cm (2). When accounting for the subaortic velocity, mean gradients averaged from 7.5 to 10.0 mmHg, and peak gradients averaged 15.1 to 23.5 mmHg. The effective orifice area indexes ranged from 0.8 to 1.0 cm (2)/m (2). The mean postoperative left ventricular mass index was 101.6 gm/m (2). CONCLUSIONS: The IN VIVO effective orifice areas by valve size of the Mitroflow aortic pericardial bioprosthesis provide the opportunity of avoiding obstructive characteristics for all valve sizes, including optimizing the management of the small aortic annulus.

Assessment of baseline age-specific antibody prevalence and incidence of infection to novel influenza A/H1N1 2009.

OBJECTIVES: The objectives of the H1N1 2009 serological surveillance project were twofold: to document (1) the prevalence of cross-reactive antibodies to H1N1 2009 by age group in the population of England prior to arrival of the pandemic strain virus in the UK and (2) the age-specific incidence of infection by month as the pandemic progressed by measuring increases in the proportion of individuals with antibodies to H1N1 2009 by age. METHODS: Residual aliquots of samples submitted to 16 microbiology laboratories in eight regions in England in defined age groups in 2008 and stored by the Health Protection Agency serological surveillance programme were used to document age-stratified prevalence of antibodies to H1N1 2009 prior to the arrival of the pandemic in the UK. Functional antibodies to the H1N1 2009 virus were measured by haemagglutination inhibition (HI) and microneutralisation (MN) assays. For timely measurement of monthly incidence of infection with H1N1 2009 between August 2009 and April 2010, the microbiology serum collections were supplemented by collection of residual sera from chemical pathology laboratories in England. Monthly seroincidence samples were tested by HI only, apart from the final sera collected post pandemic in 2010, which were also tested by MN. Incidence during the pandemic was estimated from changes in prevalence between time points and also by a likelihood-based method. SETTING: Eight regions of England. PARTICIPANTS: Serum samples from patients accessing health care in England from whom blood samples were taken for unrelated microbiological or chemical pathology testing. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Baseline age-specific prevalence of functional antibodies to the H1NI 2009 virus prior to the arrival of the pandemic; changes in antibody prevalence during the period August 2009 to April 2010. RESULTS: Pre-existing cross-reactive antibodies to H1N1 2009 were detected in the baseline sera and increased with age, particularly in those born before 1950. The prediction of immunological protection derived from the baseline serological analysis was consistent with the lower clinical attack rates in older age groups. The high levels of susceptibility in children < 15 years, together with their mixing within school, resulted in the highest attack rates in this age group. Serological analysis by region confirms that there were geographical differences in timing of major pandemic waves. London had a big first wave among the 5- to 14-year age group, with the rest of the country reducing the gap after the second wave. Cumulative incidence in London remained higher throughout the pandemic in each age group. By the end of the second wave it is estimated that as many as 70% of school-aged children in London had been infected. Taken together, these observations are consistent with observations from previous pandemics in 1918, 1957 and 1968 - that the major impact of influenza pandemics is on younger age groups, with a pattern of morbidity and mortality distinct from seasonal influenza epidemics. CONCLUSIONS: Serological analysis of appropriately structured, age-stratified and geographically representative samples can provide an immense amount of information to set in context other measures of pandemic impact in a population, and provide the most accurate measures of population exposure. National scale seroepidemiology studies require cross-agency coordination, multidisciplinary working, and considerable scientific resource. FUNDING: The National Institute for Health Research Health Technology Assessment programme and the Health Protection Agency.

Classification of female genito-urinary tract fistula: a comprehensive review.

INTRODUCTION AND HYPOTHESIS: The aim of this paper is to review proposed classifications for genito-urinary fistulae. METHODS: A comprehensive literature review of historical texts, peer review publications, and abstracts was used to compile a listing of the existing genito-urinary fistula classification systems. RESULTS: The absence of an accepted standardized classification for female genito-urinary fistulae has resulted in the proliferation of a number of individually devised categorizations. Fistulae are described by size, location, degree of vaginal scarring, and type (whether it involves the bladder, rectum, intestines, uterus, etc). In addition, most classification systems have not been subjected to outcomes research, making them primarily descriptive in nature. CONCLUSIONS: There is a lack of consensus among fistula surgeons in adopting a standardized classification system or systems. Comparative assessment of studies and outcomes is not possible without a standardized classification system. Currently, there is no accepted standardized classification for female genito-urinary fistula.

Prevalence of benign microscopic hematuria among women with interstitial cystitis: implications for evaluation of genitourinary malignancy.

OBJECTIVES: To assess the prevalence of benign microscopic hematuria among a cohort of women with clinical interstitial cystitis (IC). METHODS: A total of 100 women were prospectively assessed for microscopic hematuria with postvoid sterile catheterization. The evaluation for all patients included urine culture, potassium sensitivity test (PST), cystoscopy with hydrodistension under general anesthesia, and symptom assessment with the Pelvic Pain and Urgency/Frequency (PUF) questionnaire. RESULTS: The mean age +/- SD was 37 +/- 15 years, with no difference noted in those with or without microscopic hematuria (P = 0.71). Microscopic hematuria was present in 24 (24%) of the 100 women. No patient had gross hematuria, positive urine culture, or cystoscopic findings suspicious for malignancy. The mean PUF score was 17 +/- 6. The PST was positive in 92 (92%) of 100 women, and 8 patients had only cystoscopic findings diagnostic of IC. The likelihood of a positive PST or positive cystoscopic findings among patients with microscopic hematuria was similar to that of patients without microscopic hematuria. The PST results correlated with the cystoscopic findings (P < 0.001). Of 36 patients with positive cystoscopic findings, 28 (78%) had a positive PST, and 28 (30%) of 92 with a positive PST had positive cystoscopy findings. CONCLUSIONS: In this cohort of women with IC, the prevalence of benign microscopic hematuria was 24%. These data suggest that in women at low risk of genitourinary malignancy who have clinical IC, microscopic hematuria may be an incidental finding.

Life skills and subjective well-being of people with disabilities: a canonical correlation analysis.

This study examined the canonical relationships between a set of life skill variables and a set of subjective well-being variables among a national sample of vocational rehabilitation clients in the USA. Self-direction, work tolerance, general employability, and self-care were related to physical, family and social, and financial well-being. This analysis also found that communication skill is related to family and social well-being, while psychological well-being is not related to any life skills in the set. The results showed that vocational rehabilitation services aimed to improve life functioning will lead to an improvement in subjective quality of life.

Psychometric validation of a subjective well-being measure for people with spinal cord injuries.

PURPOSE: The researchers examined the factorial validity and the concurrent validity of the Sense of Well-Being Inventory (SWBI) based on a sample of Canadians with spinal cord injuries (SCI) in the community. METHOD: One hundred thirty-two participants were recruited from the Alberta, Saskatchewan, Nova Scotia, and Manitoba chapters of the Canadian Paraplegic Association. Mean age of participants was 45.82 years (SD=15.67), and 77% were men. The participants were asked to complete a research packet containing a demographic questionnaire, the SWBI, and the brief version of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF). RESULTS: Factor analysis yield four factors (Psychological Well-Being, Financial Well-Being, Social and Family Well-Being, and Physical Well-Being) similar to the original SWBI. In addition, the SWBI factors in the present study correlated moderately well with the corresponding factors in the WHOQOL-BREF and with demographic variables appropriate to the respective subscale. CONCLUSIONS: The factorial validity and the concurrent validity of the SWBI were generally supported. The SWBI, as a subjective well-being measure developed specifically to relate to disability and rehabilitation, appears useful for use with people with SCI in the community.

Counselors' and consumers' derived criteria for assessing the effectiveness of rehabilitation services.

This study surveyed a group of rehabilitation counselors and consumers to obtain their consensus regarding alternative measures to assess the effectiveness of vocational rehabilitation service interventions. Results suggest that in addition to employment outcomes, other factors such as psychological, social, and economic well-being should be considered.

Measurement and interpretation of pneumococcal IgG levels for clinical management.

The detection of pneumococcal IgG antibodies is helpful for the evaluation of response to pneumococcal vaccination and need for revaccination. Results generated by the clinical assay which is currently used, in which the 23 valent polysaccharide vaccine is the antigen, were compared to those obtained by a capsular polysaccharide serotype-specific assay that measures IgG antibodies to 9 common serotypes causing invasive disease. Discrepancies in 21/47 (45%) of the results were observed in a direct comparison between the two assays. In each case a positive titre was obtained on the clinical assay but IgG levels on the serotype-specific assay were below the putative protective level of 0.2 micro g/ml for at least one of the 9 serotypes assayed. The generation of false positives by the current clinical assay is due to its lack of specificity. Antibodies to C-polysaccharide and all of the 23 serotypes included in the pneumococcal polysaccharide vaccine are incorporated into the final titre whereas the serotype-specific assay adsorbs out noncapsular polysaccharide antibodies. The discrepancies between the two assays highlight the importance of standardized assays that measure putative correlates of protection and demonstrate the need to re-evaluate the current clinical assay. A tool that allows the interpretation of the results of the serotype-specific assay is provided and its potential for assessing individual susceptibility levels to vaccine preventable pneumococcal infection is discussed.

Quality of life outcomes after heart transplantation in individuals bridged to transplant with ventricular assist devices.

BACKGROUND: Increasing numbers of individuals receive ventricular assist devices (VADs) as bridges to heart transplantation. Physical morbidity risks and benefits, and quality of life (QOL) during VAD support have been documented. Effects of pre-transplant VAD support on functional and QOL outcomes after transplantation have received no empirical attention. METHODS: Sixty-three VAD patients who received heart transplants underwent QOL evaluations of physical functioning, emotional and cognitive well-being, and social functioning at 2, 7, and 12 months after transplant (response rate = 95%). Ninety patients who had not received VADs--matched to the VAD group on cardiac-related and sociodemographic characteristics--served as longitudinal controls. RESULTS: Both VAD and non-VAD groups showed similar levels and similar, statistically significant (p < 0.05) improvement in physical functioning (sleep, body care, mobility, ambulation, overall functional status, number of somatic complaints) across the study period. Emotional well-being (elevated depressive, anxiety, and anger symptoms; post-traumatic stress disorder rate) was stable or improved in both groups, and VAD patients showed significantly lower anxiety rates. The VAD patients' post-transplant cognitive status was significantly poorer. The VAD patients were significantly less likely to return to employment; other social functioning measurers (daily concerns, interpersonal activities/involvement, role function) showed mixed effects. Cognitive impairment explained much of the association between VAD support and post-transplant employment. CONCLUSIONS: Although post-transplant physical and emotional recovery is similar in VAD and non-VAD patients, VAD patients retain more cognitive impairment and show mixed changes in social functioning. Increased attention to strategies to maximize VAD patients' cognitive capacity is required to facilitate social reintegration.