Baseline 6-Min Walk Distance Predicts Survival in Lung Transplant Candidates

In a large, prospectively followed, two-center cohort of patients listed for lung transplantation (n = 376), we used Cox proportional hazards models to determine the importance of baseline 6-min walk distance (6MWD) in predicting patient survival. 6MWD used as a continuous variable was a significant predictor of survival after adjusting for other important covariates when transplant was considered as a time-varying covariate (HR for each 500 ft increase in 6MWD = 0.57, 95% CI: 0.43–0.77, p = 0.0002). 6MWD remained an important predictor of survival in models that considered only survival to transplant (HR for each 500 ft increase in 6MWD = 0.41, 95% CI: 0.27–0.62, p < 0.0001) or survival only after transplant (HR for each 500 ft increase in 6MWD = 0.40, 95% CI: 0.22–0.72, p = 0.002). Unadjusted Kaplan-Meier analysis demonstrates significantly different survival by 6MWD tertiles (<900, 900–1200, or >1200 ft, p-value = 0.0001). In the overall model, 6MWD prediction of survival was relatively homogeneous across disease category (6MWD by disease interaction term, p-value = 0.63). Our results demonstrate a significant relationship between baseline 6MWD and survival among patients listed for lung transplantation that exists across all native disease categories and extends through transplantation. The 6MWD is thus a useful measure of both urgency and utility among patients awaiting lung transplantation.     

Prediction of absolute risk of non-spinal fractures using clinical risk factors and heel quantitative ultrasound

SUMMARY: The relationship between osteoporosis risk factors, bone quantitative ultrasound (QUS) and non-spinal fracture risk was estimated in a cohort of 5,201 postmenopausal women from Spain who were prospectively evaluated during three years. Several clinical risk factors and low heel QUS values were independently associated with non-spinal fracture risk. INTRODUCTION: Low-trauma, non-spinal fractures are a growing source of morbidity and mortality in the elderly. The aim of the present study was to examine the association of heel quantitative ultrasound (QUS) and a series of osteoporosis and fracture risk factors, with incident low energy non-spinal fractures in a population of elderly women, and to incorporate them into fracture prediction models. METHODS: 5,201 women aged 65 or older were enrolled in a three-year cohort study. Participants completed an osteoporosis and fracture risk factors questionnaire. QUS was measured at the heel with a gel-coupled device. Cox-proportional hazard analyses were performed to evaluate the association with the first incident low-trauma non-spinal fracture. RESULTS: Three hundred and eleven women (6.0%) sustained a total of 363 low-trauma fractures, including 133 forearm/wrist, 54 hip, 50 humerus, 37 leg and 17 pelvic fractures. For every standard deviation decrease in the quantitative ultrasound index, the adjusted hazard ratios (95% CI) for any non-vertebral, hip, forearm/wrist, and humerus fractures were 1.31 (1.15-1.49), 1.40 (1.01-1.95), 1.50 (1.19-1.89) and 1.35 (0.97-1.87), respectively. Similar results were observed with other QUS variables. The best predictive models indicated that age, a history of falls, a previous low-trauma fracture, a family history of fracture, a calcium intake from dairy products of less than 250 mg/day, and lower values of QUS parameters were independently associated with the risk of non-spinal fractures. CONCLUSIONS: Both clinical risk factors and QUS are independent predictors of risk of fragility non-spinal fractures. A prediction algorithm using these variables was developed to estimate the absolute risk of non-spinal fractures in elderly women in Spain.     

Could you have said no? A mixed‐methods investigation of consent to HIV tests in four African countries

Introduction

Although most studies report high frequencies of consent to HIV tests, critics argue that clients are subject to pressure, that acceptors later indicate they could not have refused, and that provider-initiated HIV testing raises serious ethical issues. We examine the meaning of consent and why clients think they could not have refused.

Methods

Clients in Burkina Faso, Kenya, Malawi and Uganda were asked about consenting to HIV tests, whether they thought they could have refused and why. Textual responses were analyzed using qualitative and statistical methods.

Results

Among 926 respondents, 77% reported they could not have said no, but in fact, 60% actively consented to test, 24% had no objection and only 7% tested without consent. There were few significant associations between categories of consent and their covariates.

Conclusions

Retrospectively asking clients if they could have refused to test for HIV overestimates coercion. Triangulating qualitative and quantitative data suggests a considerable degree of agency.     

Zenith AAA endovascular graft: intermediate-term results of the US multicenter trial

PURPOSE: The intent of this study was to assess the safety and effectiveness of the Zenith AAA Endovascular Graft compared with conventional aneurysm repair. MATERIAL AND METHODS: The study was conducted in a prospective, multicenter, nonrandomized, concurrent control manner. Physiologically similar patients with infrarenal abdominal aortic aneurysms (AAAs) underwent either open surgery or repair with the Zenith AAA Endovascular Graft. Separate analyses of physiologically challenged patients were performed. Follow-up was conducted at hospital discharge and at 1, 6, and 12 months (endovascular repair group) or 1 and 12 months (open surgical repair group). Evaluation included computed tomography, abdominal radiography, laboratory tests, and physical examination. Mortality (AAA-related and overall), morbidity, in-hospital recovery, renal function, and secondary interventions were assessed. Patients in the endovascular repair group were evaluated for change in aneurysm size, endoleak, graft migration, conversion, rupture, and device integrity. Statistical analyses were performed with the Kaplan-Meier method, Blackwelder test, propensity score assessment, two-sample t test, Yates-corrected Pearson chi(2) test, and Fisher exact test. RESULTS: Conventional open surgery was used in 80 patients, and 200 patients underwent repair with the Zenith AAA Endovascular Graft. Technical success was accomplished in 98.8% of patients in the open repair group and 99.5% in the endovascular repair group. Patients in the endovascular repair group had fewer significant adverse events within 30 days (80% vs 57%; P <.001). All-cause mortality was similar (endovascular, 3.5%; open surgery, 3.8%). Aneurysm-related mortality was higher with conventional surgery at 12 months (3.8% vs 0.5%; P =.04). In-hospital recovery and procedural measures were better for endovascular repair in all categories (P <.001). The incidence of endoleak was 17% at 30 days, 7.4% at 12 months, and 5.4% at 24 months. Aneurysm shrinkage (>5 mm) was noted in more than two thirds of patients at 12 months and three fourths of patients at 24 months. Renal dysfunction rate did not differ between groups. Migration (>5 mm) was detected in four (2%) patients through 12 months; none was greater than 10 mm or associated with adverse events through 24 months. Three conversions were performed within 12 months, one because of aneurysm rupture. Secondary procedures were more common in the endovascular group (11% vs 2.5%; P =.03). In total, 351 patients had endografts implanted, and 6 patients were noted to have barb separations through 12-month follow-up. No stent fractures were noted. CONCLUSIONS: The Zenith AAA Endovascular Graft is safe and effective for treatment of infrarenal AAAs. The high likelihood of decrease in aneurysm size provides evidence that treatment of aneurysms with this device reverses the natural history of aneurysmal disease. The importance of long-term follow-up is underscored by the small but defined incidence of barb separation and the potential for unforeseen failure modes.     

Influence of endograft oversizing on device migration, endoleak, aneurysm shrinkage, and aortic neck dilation: results from the Zenith Multicenter Trial

BACKGROUND: Generous endograft oversizing has been associated with propensity for aortic neck dilation and subsequent device migration in endografts without suprarenal fixation. Effects of variable oversizing of endografts with suprarenal fixation have been poorly studied. METHODS: Three hundred fifty-one patients underwent endovascular AAA repair (EVAR) in a prospective multicenter trial using the Zenith AAA Endovascular Graft, a fully supported bifurcated 3-piece endograft with barb-enhanced suprarenal stent fixation. Blinded core-laboratory measurement of variables was prospectively recorded at predischarge and at 1, 6, 12, and 24 months after the procedure. Potential influence of endograft oversizing on subsequent aortic neck dilation (minor axis), aneurysm shrinkage (major axis), device migration, endoleak, rupture, open conversion, and death were retrospectively studied. Data are given as mean +/- SEM. RESULTS: Risk of endograft migration (>5mm) at 12 months was 2.3% (6/261). However, patients with endograft oversizing of >30% had a 14% (4/29) migration risk compared with those oversized < or =30% (0.9%, 2/232), P <.002. There was zero device migration by the SVS definition (>10 mm or clinical event). Device oversizing >30% was associated with decreased AAA sac shrinkage (48% vs 77%) and with increased sac enlargement (9.5% vs 0.6%) at 24 months when compared with oversizing of < or =30%, respectively (P =.001). Incidence rate of any endoleak at 12 and 24 months was 8.2% (21/256) and 7.1% (12/169), respectively. Oversizing of endografts by >30% was associated with an increased type II endoleak rate (11 vs 4.7%) that failed to reach statistical significance (P =.27). Aortic neck diameters increased significantly by 6 months (P <.001) but then stabilized through 24 months; the absolute changes at 1 (n = 298), 6 (n = 278), 12 (n = 264), and 24 months (n = 171) were 0.66 +/- 0.10 mm (3.0%), 1.32 +/- 0.11 mm (5.6%), 1.38 +/- 0.12 mm (5.9%), and 1.44 +/- 0.16 mm (6.1%), respectively. Linear regression analysis demonstrated no correlation between endograft oversizing and aortic neck dilation at 12 (P =.86) or 24 months (P =.64). CONCLUSIONS: Device migration and endoleaks were very infrequent after treatment with the Zenith AAA Endovascular Graft. However, endograft oversizing of >30% was associated with an approximately 14-fold increase in device migration (>5 mm) at 12 months and with a approximately 16-fold increased risk of AAA expansion at 24 months. Although further follow-up will be essential to assess whether these early associations continue, avoidance of excessive endograft oversizing is recommended.     

Renal function and safety in stable kidney transplant recipients converted from immediate-release to prolonged-release tacrolimus

This multicenter, open, phase IIIb study assessed short-term efficacy, safety and dose adjustments in adult stable renal transplant recipients converted from tacrolimus twice-daily (BID) to once-daily (QD). Patients receiving unchanged tacrolimus BID for ≥ 12 weeks were enrolled, and after 6-weeks, converted from tacrolimus BID to QD (morning dose) on a 1 : 1 (mg : mg) total daily dose basis, for a further 12 weeks. Primary endpoint: change in steady-state creatinine clearance between treatment phases. Secondary endpoints: biopsy-proven acute rejection (BPAR), patient and graft survival, safety. 128 patients enrolled (mean age 48.9 years; time post-transplant 48.9 months); 91 evaluated for the primary endpoint. Mean total daily dose was 0.06 mg/kg (BID) and 0.07 mg/kg (QD); 79.1% required one/no dose changes post-conversion to maintain recommended blood-trough levels; average dose increase was small (0.6-0.7 mg/day) with more dose increases in patients on the lowest tacrolimus BID doses. Renal function remained stable and non-inferiority of tacrolimus QD against tacrolimus BID was demonstrated. There were no BPAR episodes; patient and graft survival were 100%. Adverse events were few; none led to dose modifications/discontinuation. Tacrolimus BID to tacrolimus QD conversion is straightforward and does not compromise renal function in stable kidney transplant patients in the short term.     

经口内镜下肌切开术、肉毒素注射和球囊扩张治疗贲门失弛缓症的随机对照研究

目的 通过随机对照的临床研究来对比经口内镜下肌切开术(POEM)、肉毒素注射(BTI)和球囊扩张(BD)治疗贲门失弛缓症的安全性和有效性。方法 2011年11月至2012年5月45例贲门失弛缓症患者被随机平均分配到POEM组、BTI组和BD组。对治疗后3个月的疗效和安全性进行对比分析。主要结果是症状缓解率,次要结果是并发症发生率、下食管括约肌压力(LESP)和食管最大宽度。结果 所有45例患者均成功进行了内镜下的治疗,并且治疗后3个月随访成功率为100%。症状缓解率POEM组为100%,BTI组为66.7%,BD组为93.3%,其中POEM组和BTI组两组间的差异有统计学意义(P<0.05),而POEM组与BD组、BD组与BTI组之间差异无统计学意义。并发症发生率POEM组为13.3%,BTI组为0,BD组为6.7%,但3组间的差异无统计学意义。LESP、食管最大宽度在3组之间比较,术前和术后的差异均无统计学意义。结论 治疗后3个月,POEM的症状缓解率高于BTI和BD,而并发症发生率3种方法相似。     

Differing risk profiles for individual fracture sites: Evidence from the global longitudinal study of osteoporosis in women (GLOW)

The purposes of this study were to examine fracture risk profiles at specific bone sites, and to understand why model discrimination using clinical risk factors is generally better in hip fracture models than in models that combine hip with other bones. Using 3-year data from the GLOW study (54,229 women with more than 4400 total fractures), we present Cox regression model results for 10 individual fracture sites, for both any and first-time fracture, among women aged ≥55 years. Advanced age is the strongest risk factor in hip (hazard ratio [HR] = 2.3 per 10-year increase), pelvis (HR = 1.8), upper leg (HR = 1.8), and clavicle (HR = 1.7) models. Age has a weaker association with wrist (HR = 1.1), rib (HR = 1.2), lower leg (not statistically significant), and ankle (HR = 0.81) fractures. Greater weight is associated with reduced risk for hip, pelvis, spine, and wrist, but higher risk for first lower leg and ankle fractures. Prior fracture of the same bone, although significant in nine of 10 models, is most strongly associated with spine (HR = 6.6) and rib (HR = 4.8) fractures. Past falls are important in all but spine models. Model c indices are ≥0.71 for hip, pelvis, upper leg, spine, clavicle, and rib, but ≤0.66 for upper arm/shoulder, lower leg, wrist, and ankle fractures. The c index for combining hip, spine, upper arm, and wrist (major fracture) is 0.67. First-time fracture models have c indices ranging from 0.59 for wrist to 0.78 for hip and pelvis. The c index for first-time major fracture is 0.63. In conclusion, substantial differences in risk profiles exist among the 10 bones considered. © 2012 American Society for Bone and Mineral Research.     

Gender-related differences in clinical and pathological characteristics and therapy of bladder cancer

OBJECTIVE: To confirm the very high male:female ratios previously observed among Spanish bladder cancer patients and to assess gender differences in tumoral characteristics, diagnostic procedures, and treatment in a large series of consecutive bladder cancer patients. PATIENTS AND METHODS: All newly diagnosed bladder cancer patients (n=615) in 17 Spanish hospitals, between 1997-2000, were included. Information was collected both through personal interviews to patients and from medical records using a structured form. RESULTS: Seventy-six percent of tumours were superficial. The male:female ratio was 6.7 and it was similar for superficial and infiltrating tumours. Women were older than men at the diagnosis of bladder cancer (68.2+/-9.4 years versus 65.7+/-9.7 years, p=0.01). Ten percent of superficial tumours in women, versus 3% in men, were classified as "other histological types" (p=0.008). T1GIII tumours were more frequent among men (17% versus 7%, p=0.047). On the other hand, women were more likely to present with 0a-stage tumours (48.6% versus 35.5%, p=0.04), multiple tumours (50% versus 29%, trend test: 0.005), multi-centric tumours (54% versus 38%, p=0.019), and larger infiltrating masses (5.2 cm versus 3.8 cm, p=0.03) than men. Among 0a-stage tumours, only 23% of women compared to 54% of men received transurethral resection (TUR) alone (p=0.002). Women were almost five-fold more likely to receive additional therapies to TUR (p=0.004) after adjusting for age, geographical area, stage, tumoral size, nuclear grade, and multiplicity. CONCLUSION: The study confirms the very high male:female ratio of bladder cancer in Spain. We found substantial differences in the pathological characteristics of tumours from men and women. There was a tendency for women to receive more frequently non-standard, more aggressive, therapy than men.